Luminaries in Structural Heart

In this episode, Dr. Ashwin Murthy and Dr. Nima Aghili explore HALT after TAVR, including its imaging characteristics, contributing factors, clinical significance, and natural progression. They discuss when to monitor versus treat HALT, anticoagulation strategies, and key insights from the GALILEO trial.

Indications

The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥8% at 30 days, based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Contraindications

Warnings

Precautions

—the degenerated TAV presents with a significant concomitant paravalvular leak (between the prosthesis and the native annulus),

—the degenerated TAV is not securely fixed in the native annulus, or is not structurally intact (for example, frame fracture) or

—the risk of coronary obstruction or sinus sequestration after Evolut PRO+, Evolut FX, or Evolut FX+ implantation is high. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in patient populations presenting with the following: Blood dyscrasias as defined as leukopenia (WBC < 1,000 cells/mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states; congenital unicuspid valve; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation [3-4+]); moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation; hypertrophic obstructive cardiomyopathy; new or untreated echocardiographic evidence of intracardiac mass, thrombus, or vegetation; native aortic annulus size < 18 mm or > 30 mm per the baseline diagnostic imaging or a surgical bioprosthetic or failed transcatheter aortic annulus size < 17 mm or > 30 mm; transarterial access unable to accommodate an 18 Fr introducer sheath or the 14 Fr equivalent Evolut PRO+ inline sheath when using model D-EVPROP2329US or Evolut FX Delivery Catheter System with inline sheath when using model D-EVOLUTFX-2329 or transarterial access unable to accommodate a 22 Fr introducer sheath or the 18 Fr equivalent Evolut PRO+ inline sheath when using model D-EVPROP34US or Evolut FX Delivery Catheter System with inline sheath when using model D-EVOLUTFX-34; prohibitive left ventricular outflow tract calcification; sinus of Valsalva anatomy that would prevent adequate coronary perfusion; significant aortopathy requiring ascending aortic replacement; moderate to severe mitral stenosis; severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%; symptomatic carotid or vertebral artery disease; and severe basal septal hypertrophy with an outflow gradient.

Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure to the vapors. Damage may result from forceful handling of the catheter. Prevent kinking of the catheter when removing it from the packaging. The bioprosthesis size must be appropriate to fit the patient’s anatomy. Proper sizing of the devices is the responsibility of the physician. Refer to the Instructions for Use for available sizes. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. Patients must present with transarterial access vessel diameters of ≥ 5 mm when using models D-EVPROP2329US/D-EVOLUTFX-2329 or ≥ 6 mm when using models D-EVPROP34US/D-EVOLUTFX-34, or patients must present with an ascending aortic (direct aortic) access site ≥ 60 mm from the basal plane for both systems. Implantation of the bioprosthesis should be avoided in patients with aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) of > 30° for right subclavian/axillary access or > 70° for femoral and left subclavian/axillary access. For subclavian/axillary access, patients with a patent left internal mammary artery (LIMA) graft must present with access vessel diameters that are either ≥ 5.5 mm when using models D-EVPROP2329US/D-EVOLUTFX-2329 or ≥ 6.5 mm when using models D-EVPROP34US/D-EVOLUTFX-34. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. For transfemoral access, use caution in patients who present with multiplanar curvature of the aorta, acute angulation of the aortic arch, an ascending aortic aneurysm, or severe calcification in the aorta and/or vasculature. If ≥ 2 of these factors are present, consider an alternative access route to prevent vascular complications. Limited clinical data are available for transcatheter aortic valve replacement in patients with a congenital bicuspid aortic valve who are deemed to be at low surgical risk. Anatomical characteristics should be considered when using the valve in this population. In addition, patient age should be considered as long-term durability of the valve has not been established.

During Use If a misload is detected during fluoroscopic inspection, do not attempt to reload the bioprosthesis. Discard the entire system. Inflow crown overlap that has not ended before the 4th node within the capsule increases the risk of an infold upon deployment in constrained anatomies, particularly with moderate-severe levels of calcification and/or bicuspid condition. Do not attempt to direct load the valve. After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. Excessive contrast media may cause renal failure. Prior to the procedure, measure the patient’s creatinine level. During the procedure, monitor contrast media usage. Conduct the procedure under fluoroscopy. Fluoroscopic procedures are associated with the risk of radiation damage to the skin, which may be painful, disfiguring, and long-term. For TAV in TAV procedures, failed valve size and patient anatomy must be considered before implantation of the Evolut PRO+, Evolut FX, or Evolut FX+ bioprosthesis to ensure patient safety (for example, to avoid coronary obstruction).

Potential adverse events

Potential risks associated with the implantation of the Evolut PRO+, Evolut FX, or Evolut FX+ transcatheter aortic valve may include, but are not limited to, the following: • death • myocardial infarction, cardiac arrest, cardiogenic shock, or cardiac tamponade • coronary occlusion, obstruction, or vessel spasm (including acute coronary closure) • cardiovascular injury (including rupture, perforation, tissue erosion, or dissection of vessels, ascending aorta trauma, ventricle, myocardium, or valvular structures that may require intervention) • emergent surgical or transcatheter intervention (e.g., coronary artery bypass, heart valve replacement, valve explant, percutaneous coronary intervention [PCI], balloon valvuloplasty) • prosthetic valve dysfunction (regurgitation or stenosis) due to fracture; bending (out-of-round configuration) of the valve frame; underexpansion of the valve frame; calcification; pannus; leaflet wear, tear, prolapse, or retraction; poor valve coaptation; suture breaks or disruption; leaks; mal-sizing (prosthesis-patient mismatch); malposition (either too high or too low)/malplacement – prosthetic valve migration/embolization • prosthetic valve endocarditis • prosthetic valve thrombosis • delivery catheter system malfunction resulting in the need for additional recrossing of the aortic valve and prolonged procedural time • delivery catheter system component embolization  • stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), or other neurological deficits • individual organ (e.g., cardiac, respiratory, renal [including acute kidney failure]) or multi-organ insufficiency or failure • major or minor bleeding that may require transfusion or intervention (including life-threatening or disabling bleeding) • vascular access-related complications (e.g., dissection, perforation, pain, bleeding, hematoma, pseudoaneurysm, irreversible nerve injury, compartment syndrome, arteriovenous fistula, or stenosis) • mitral valve regurgitation or injury • conduction system disturbances (e.g., atrioventricular node block, left bundle-branch block, asystole), which may require a permanent pacemaker • infection (including septicemia) • hypotension or hypertension • hemolysis • peripheral ischemia • General surgical risks applicable to transcatheter aortic valve implantation: • bowel ischemia • abnormal lab values (including electrolyte imbalance) • allergic reaction to antiplatelet agents, contrast medium, or anesthesia • exposure to radiation through fluoroscopy and angiography • permanent disability.

Please reference the Evolut PRO+, Evolut FX, and Evolut FX+ Instructions for Use for more information regarding indications, warnings, precautions, and potential adverse events.

Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician.

The commercial name of the Evolut™ PRO+ device is Medtronic Evolut™ PRO+ System, the commercial name of the Evolut™ FX device is Medtronic Evolut™ FX System, and the commercial name of the Evolut™ FX+ device is Medtronic Evolut™ FX+ System.

Join host Andrea Scotti and guest Puja Parikh as they discuss career growth in cardiology—covering mentorship, research, publishing, and leadership strategies to help early career physicians build impactful, successful paths in structural heart. #StructuralHeart, #InterventionalCardiology, #LuminariesInStructuralHeart, #MedEd, #CardiologyCommunity

Indications

The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥8% at 30 days, based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Contraindications

Warnings

Precautions

—the degenerated TAV presents with a significant concomitant paravalvular leak (between the prosthesis and the native annulus),

—the degenerated TAV is not securely fixed in the native annulus, or is not structurally intact (for example, frame fracture) or

—the risk of coronary obstruction or sinus sequestration after Evolut PRO+, Evolut FX, or Evolut FX+ implantation is high. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in patient populations presenting with the following: Blood dyscrasias as defined as leukopenia (WBC < 1,000 cells/mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states; congenital unicuspid valve; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation [3-4+]); moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation; hypertrophic obstructive cardiomyopathy; new or untreated echocardiographic evidence of intracardiac mass, thrombus, or vegetation; native aortic annulus size < 18 mm or > 30 mm per the baseline diagnostic imaging or a surgical bioprosthetic or failed transcatheter aortic annulus size < 17 mm or > 30 mm; transarterial access unable to accommodate an 18 Fr introducer sheath or the 14 Fr equivalent Evolut PRO+ inline sheath when using model D-EVPROP2329US or Evolut FX Delivery Catheter System with inline sheath when using model D-EVOLUTFX-2329 or transarterial access unable to accommodate a 22 Fr introducer sheath or the 18 Fr equivalent Evolut PRO+ inline sheath when using model D-EVPROP34US or Evolut FX Delivery Catheter System with inline sheath when using model D-EVOLUTFX-34; prohibitive left ventricular outflow tract calcification; sinus of Valsalva anatomy that would prevent adequate coronary perfusion; significant aortopathy requiring ascending aortic replacement; moderate to severe mitral stenosis; severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%; symptomatic carotid or vertebral artery disease; and severe basal septal hypertrophy with an outflow gradient.

Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure to the vapors. Damage may result from forceful handling of the catheter. Prevent kinking of the catheter when removing it from the packaging. The bioprosthesis size must be appropriate to fit the patient’s anatomy. Proper sizing of the devices is the responsibility of the physician. Refer to the Instructions for Use for available sizes. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. Patients must present with transarterial access vessel diameters of ≥ 5 mm when using models D-EVPROP2329US/D-EVOLUTFX-2329 or ≥ 6 mm when using models D-EVPROP34US/D-EVOLUTFX-34, or patients must present with an ascending aortic (direct aortic) access site ≥ 60 mm from the basal plane for both systems. Implantation of the bioprosthesis should be avoided in patients with aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) of > 30° for right subclavian/axillary access or > 70° for femoral and left subclavian/axillary access. For subclavian/axillary access, patients with a patent left internal mammary artery (LIMA) graft must present with access vessel diameters that are either ≥ 5.5 mm when using models D-EVPROP2329US/D-EVOLUTFX-2329 or ≥ 6.5 mm when using models D-EVPROP34US/D-EVOLUTFX-34. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. For transfemoral access, use caution in patients who present with multiplanar curvature of the aorta, acute angulation of the aortic arch, an ascending aortic aneurysm, or severe calcification in the aorta and/or vasculature. If ≥ 2 of these factors are present, consider an alternative access route to prevent vascular complications. Limited clinical data are available for transcatheter aortic valve replacement in patients with a congenital bicuspid aortic valve who are deemed to be at low surgical risk. Anatomical characteristics should be considered when using the valve in this population. In addition, patient age should be considered as long-term durability of the valve has not been established.

During Use If a misload is detected during fluoroscopic inspection, do not attempt to reload the bioprosthesis. Discard the entire system. Inflow crown overlap that has not ended before the 4th node within the capsule increases the risk of an infold upon deployment in constrained anatomies, particularly with moderate-severe levels of calcification and/or bicuspid condition. Do not attempt to direct load the valve. After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. Excessive contrast media may cause renal failure. Prior to the procedure, measure the patient’s creatinine level. During the procedure, monitor contrast media usage. Conduct the procedure under fluoroscopy. Fluoroscopic procedures are associated with the risk of radiation damage to the skin, which may be painful, disfiguring, and long-term. For TAV in TAV procedures, failed valve size and patient anatomy must be considered before implantation of the Evolut PRO+, Evolut FX, or Evolut FX+ bioprosthesis to ensure patient safety (for example, to avoid coronary obstruction).

Potential adverse events

Potential risks associated with the implantation of the Evolut PRO+, Evolut FX, or Evolut FX+ transcatheter aortic valve may include, but are not limited to, the following: • death • myocardial infarction, cardiac arrest, cardiogenic shock, or cardiac tamponade • coronary occlusion, obstruction, or vessel spasm (including acute coronary closure) • cardiovascular injury (including rupture, perforation, tissue erosion, or dissection of vessels, ascending aorta trauma, ventricle, myocardium, or valvular structures that may require intervention) • emergent surgical or transcatheter intervention (e.g., coronary artery bypass, heart valve replacement, valve explant, percutaneous coronary intervention [PCI], balloon valvuloplasty) • prosthetic valve dysfunction (regurgitation or stenosis) due to fracture; bending (out-of-round configuration) of the valve frame; underexpansion of the valve frame; calcification; pannus; leaflet wear, tear, prolapse, or retraction; poor valve coaptation; suture breaks or disruption; leaks; mal-sizing (prosthesis-patient mismatch); malposition (either too high or too low)/malplacement – prosthetic valve migration/embolization • prosthetic valve endocarditis • prosthetic valve thrombosis • delivery catheter system malfunction resulting in the need for additional recrossing of the aortic valve and prolonged procedural time • delivery catheter system component embolization  • stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), or other neurological deficits • individual organ (e.g., cardiac, respiratory, renal [including acute kidney failure]) or multi-organ insufficiency or failure • major or minor bleeding that may require transfusion or intervention (including life-threatening or disabling bleeding) • vascular access-related complications (e.g., dissection, perforation, pain, bleeding, hematoma, pseudoaneurysm, irreversible nerve injury, compartment syndrome, arteriovenous fistula, or stenosis) • mitral valve regurgitation or injury • conduction system disturbances (e.g., atrioventricular node block, left bundle-branch block, asystole), which may require a permanent pacemaker • infection (including septicemia) • hypotension or hypertension • hemolysis • peripheral ischemia • General surgical risks applicable to transcatheter aortic valve implantation: • bowel ischemia • abnormal lab values (including electrolyte imbalance) • allergic reaction to antiplatelet agents, contrast medium, or anesthesia • exposure to radiation through fluoroscopy and angiography • permanent disability.

Please reference the Evolut PRO+, Evolut FX, and Evolut FX+ Instructions for Use for more information regarding indications, warnings, precautions, and potential adverse events.

Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician.

The commercial name of the Evolut™ PRO+ device is Medtronic Evolut™ PRO+ System, the commercial name of the Evolut™ FX device is Medtronic Evolut™ FX System, and the commercial name of the Evolut™ FX+ device is Medtronic Evolut™ FX+ System.

Join Dr. Guilherme Attizzani and Dr. Jai Parekh for an expert discussion on coronary cannulation and access strategies after TAVR, highlighting commissural alignment, device evolution, procedural techniques, and evidence demonstrating reliable coronary access and improved outcomes with contemporary Evolut platforms.

Indications

The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥8% at 30 days, based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Contraindications

Warnings

Precautions

—the degenerated TAV presents with a significant concomitant paravalvular leak (between the prosthesis and the native annulus),

—the degenerated TAV is not securely fixed in the native annulus, or is not structurally intact (for example, frame fracture) or

—the risk of coronary obstruction or sinus sequestration after Evolut PRO+, Evolut FX, or Evolut FX+ implantation is high. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in patient populations presenting with the following: Blood dyscrasias as defined as leukopenia (WBC < 1,000 cells/mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states; congenital unicuspid valve; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation [3-4+]); moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation; hypertrophic obstructive cardiomyopathy; new or untreated echocardiographic evidence of intracardiac mass, thrombus, or vegetation; native aortic annulus size < 18 mm or > 30 mm per the baseline diagnostic imaging or a surgical bioprosthetic or failed transcatheter aortic annulus size < 17 mm or > 30 mm; transarterial access unable to accommodate an 18 Fr introducer sheath or the 14 Fr equivalent Evolut PRO+ inline sheath when using model D-EVPROP2329US or Evolut FX Delivery Catheter System with inline sheath when using model D-EVOLUTFX-2329 or transarterial access unable to accommodate a 22 Fr introducer sheath or the 18 Fr equivalent Evolut PRO+ inline sheath when using model D-EVPROP34US or Evolut FX Delivery Catheter System with inline sheath when using model D-EVOLUTFX-34; prohibitive left ventricular outflow tract calcification; sinus of Valsalva anatomy that would prevent adequate coronary perfusion; significant aortopathy requiring ascending aortic replacement; moderate to severe mitral stenosis; severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%; symptomatic carotid or vertebral artery disease; and severe basal septal hypertrophy with an outflow gradient.

Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure to the vapors. Damage may result from forceful handling of the catheter. Prevent kinking of the catheter when removing it from the packaging. The bioprosthesis size must be appropriate to fit the patient’s anatomy. Proper sizing of the devices is the responsibility of the physician. Refer to the Instructions for Use for available sizes. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. Patients must present with transarterial access vessel diameters of ≥ 5 mm when using models D-EVPROP2329US/D-EVOLUTFX-2329 or ≥ 6 mm when using models D-EVPROP34US/D-EVOLUTFX-34, or patients must present with an ascending aortic (direct aortic) access site ≥ 60 mm from the basal plane for both systems. Implantation of the bioprosthesis should be avoided in patients with aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) of > 30° for right subclavian/axillary access or > 70° for femoral and left subclavian/axillary access. For subclavian/axillary access, patients with a patent left internal mammary artery (LIMA) graft must present with access vessel diameters that are either ≥ 5.5 mm when using models D-EVPROP2329US/D-EVOLUTFX-2329 or ≥ 6.5 mm when using models D-EVPROP34US/D-EVOLUTFX-34. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. For transfemoral access, use caution in patients who present with multiplanar curvature of the aorta, acute angulation of the aortic arch, an ascending aortic aneurysm, or severe calcification in the aorta and/or vasculature. If ≥ 2 of these factors are present, consider an alternative access route to prevent vascular complications. Limited clinical data are available for transcatheter aortic valve replacement in patients with a congenital bicuspid aortic valve who are deemed to be at low surgical risk. Anatomical characteristics should be considered when using the valve in this population. In addition, patient age should be considered as long-term durability of the valve has not been established.

During Use If a misload is detected during fluoroscopic inspection, do not attempt to reload the bioprosthesis. Discard the entire system. Inflow crown overlap that has not ended before the 4th node within the capsule increases the risk of an infold upon deployment in constrained anatomies, particularly with moderate-severe levels of calcification and/or bicuspid condition. Do not attempt to direct load the valve. After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. Excessive contrast media may cause renal failure. Prior to the procedure, measure the patient’s creatinine level. During the procedure, monitor contrast media usage. Conduct the procedure under fluoroscopy. Fluoroscopic procedures are associated with the risk of radiation damage to the skin, which may be painful, disfiguring, and long-term. For TAV in TAV procedures, failed valve size and patient anatomy must be considered before implantation of the Evolut PRO+, Evolut FX, or Evolut FX+ bioprosthesis to ensure patient safety (for example, to avoid coronary obstruction).

Potential adverse events

Potential risks associated with the implantation of the Evolut PRO+, Evolut FX, or Evolut FX+ transcatheter aortic valve may include, but are not limited to, the following: • death • myocardial infarction, cardiac arrest, cardiogenic shock, or cardiac tamponade • coronary occlusion, obstruction, or vessel spasm (including acute coronary closure) • cardiovascular injury (including rupture, perforation, tissue erosion, or dissection of vessels, ascending aorta trauma, ventricle, myocardium, or valvular structures that may require intervention) • emergent surgical or transcatheter intervention (e.g., coronary artery bypass, heart valve replacement, valve explant, percutaneous coronary intervention [PCI], balloon valvuloplasty) • prosthetic valve dysfunction (regurgitation or stenosis) due to fracture; bending (out-of-round configuration) of the valve frame; underexpansion of the valve frame; calcification; pannus; leaflet wear, tear, prolapse, or retraction; poor valve coaptation; suture breaks or disruption; leaks; mal-sizing (prosthesis-patient mismatch); malposition (either too high or too low)/malplacement – prosthetic valve migration/embolization • prosthetic valve endocarditis • prosthetic valve thrombosis • delivery catheter system malfunction resulting in the need for additional recrossing of the aortic valve and prolonged procedural time • delivery catheter system component embolization  • stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), or other neurological deficits • individual organ (e.g., cardiac, respiratory, renal [including acute kidney failure]) or multi-organ insufficiency or failure • major or minor bleeding that may require transfusion or intervention (including life-threatening or disabling bleeding) • vascular access-related complications (e.g., dissection, perforation, pain, bleeding, hematoma, pseudoaneurysm, irreversible nerve injury, compartment syndrome, arteriovenous fistula, or stenosis) • mitral valve regurgitation or injury • conduction system disturbances (e.g., atrioventricular node block, left bundle-branch block, asystole), which may require a permanent pacemaker • infection (including septicemia) • hypotension or hypertension • hemolysis • peripheral ischemia • General surgical risks applicable to transcatheter aortic valve implantation: • bowel ischemia • abnormal lab values (including electrolyte imbalance) • allergic reaction to antiplatelet agents, contrast medium, or anesthesia • exposure to radiation through fluoroscopy and angiography • permanent disability.

Please reference the Evolut PRO+, Evolut FX, and Evolut FX+ Instructions for Use for more information regarding indications, warnings, precautions, and potential adverse events.

Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician.

The commercial name of the Evolut™ PRO+ device is Medtronic Evolut™ PRO+ System, the commercial name of the Evolut™ FX device is Medtronic Evolut™ FX System, and the commercial name of the Evolut™ FX+ device is Medtronic Evolut™ FX+ System.

In this new episode, Marcus R. Burns, DNP, RCIS, AACC, Structural Interventional Cardiology at Minneapolis Heart Institute (MHI)/Abbott Northwestern, shares how his team evaluated their own small-annulus TAVR outcomes and compared their real-world experience with findings from the SMART trial. Marcus discusses what prompted the analysis, how his team collected and followed their institutional data through three years, and how their findings compared with trends observed in SMART. He also shares how these insights have influenced their approach to valve selection, hemodynamics, longitudinal follow-up, and heart-team decision-making for patients with small annuli.

Indications

The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥8% at 30 days, based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Contraindications

Warnings

Precautions

—the degenerated TAV presents with a significant concomitant paravalvular leak (between the prosthesis and the native annulus),

—the degenerated TAV is not securely fixed in the native annulus, or is not structurally intact (for example, frame fracture) or

—the risk of coronary obstruction or sinus sequestration after Evolut PRO+, Evolut FX, or Evolut FX+ implantation is high. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in patient populations presenting with the following: Blood dyscrasias as defined as leukopenia (WBC < 1,000 cells/mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states; congenital unicuspid valve; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation [3-4+]); moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation; hypertrophic obstructive cardiomyopathy; new or untreated echocardiographic evidence of intracardiac mass, thrombus, or vegetation; native aortic annulus size < 18 mm or > 30 mm per the baseline diagnostic imaging or a surgical bioprosthetic or failed transcatheter aortic annulus size < 17 mm or > 30 mm; transarterial access unable to accommodate an 18 Fr introducer sheath or the 14 Fr equivalent Evolut PRO+ inline sheath when using model D-EVPROP2329US or Evolut FX Delivery Catheter System with inline sheath when using model D-EVOLUTFX-2329 or transarterial access unable to accommodate a 22 Fr introducer sheath or the 18 Fr equivalent Evolut PRO+ inline sheath when using model D-EVPROP34US or Evolut FX Delivery Catheter System with inline sheath when using model D-EVOLUTFX-34; prohibitive left ventricular outflow tract calcification; sinus of Valsalva anatomy that would prevent adequate coronary perfusion; significant aortopathy requiring ascending aortic replacement; moderate to severe mitral stenosis; severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%; symptomatic carotid or vertebral artery disease; and severe basal septal hypertrophy with an outflow gradient.

Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure to the vapors. Damage may result from forceful handling of the catheter. Prevent kinking of the catheter when removing it from the packaging. The bioprosthesis size must be appropriate to fit the patient’s anatomy. Proper sizing of the devices is the responsibility of the physician. Refer to the Instructions for Use for available sizes. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. Patients must present with transarterial access vessel diameters of ≥ 5 mm when using models D-EVPROP2329US/D-EVOLUTFX-2329 or ≥ 6 mm when using models D-EVPROP34US/D-EVOLUTFX-34, or patients must present with an ascending aortic (direct aortic) access site ≥ 60 mm from the basal plane for both systems. Implantation of the bioprosthesis should be avoided in patients with aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) of > 30° for right subclavian/axillary access or > 70° for femoral and left subclavian/axillary access. For subclavian/axillary access, patients with a patent left internal mammary artery (LIMA) graft must present with access vessel diameters that are either ≥ 5.5 mm when using models D-EVPROP2329US/D-EVOLUTFX-2329 or ≥ 6.5 mm when using models D-EVPROP34US/D-EVOLUTFX-34. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. For transfemoral access, use caution in patients who present with multiplanar curvature of the aorta, acute angulation of the aortic arch, an ascending aortic aneurysm, or severe calcification in the aorta and/or vasculature. If ≥ 2 of these factors are present, consider an alternative access route to prevent vascular complications. Limited clinical data are available for transcatheter aortic valve replacement in patients with a congenital bicuspid aortic valve who are deemed to be at low surgical risk. Anatomical characteristics should be considered when using the valve in this population. In addition, patient age should be considered as long-term durability of the valve has not been established.

During Use If a misload is detected during fluoroscopic inspection, do not attempt to reload the bioprosthesis. Discard the entire system. Inflow crown overlap that has not ended before the 4th node within the capsule increases the risk of an infold upon deployment in constrained anatomies, particularly with moderate-severe levels of calcification and/or bicuspid condition. Do not attempt to direct load the valve. After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. Excessive contrast media may cause renal failure. Prior to the procedure, measure the patient’s creatinine level. During the procedure, monitor contrast media usage. Conduct the procedure under fluoroscopy. Fluoroscopic procedures are associated with the risk of radiation damage to the skin, which may be painful, disfiguring, and long-term. For TAV in TAV procedures, failed valve size and patient anatomy must be considered before implantation of the Evolut PRO+, Evolut FX, or Evolut FX+ bioprosthesis to ensure patient safety (for example, to avoid coronary obstruction).

Potential adverse events

Potential risks associated with the implantation of the Evolut PRO+, Evolut FX, or Evolut FX+ transcatheter aortic valve may include, but are not limited to, the following: • death • myocardial infarction, cardiac arrest, cardiogenic shock, or cardiac tamponade • coronary occlusion, obstruction, or vessel spasm (including acute coronary closure) • cardiovascular injury (including rupture, perforation, tissue erosion, or dissection of vessels, ascending aorta trauma, ventricle, myocardium, or valvular structures that may require intervention) • emergent surgical or transcatheter intervention (e.g., coronary artery bypass, heart valve replacement, valve explant, percutaneous coronary intervention [PCI], balloon valvuloplasty) • prosthetic valve dysfunction (regurgitation or stenosis) due to fracture; bending (out-of-round configuration) of the valve frame; underexpansion of the valve frame; calcification; pannus; leaflet wear, tear, prolapse, or retraction; poor valve coaptation; suture breaks or disruption; leaks; mal-sizing (prosthesis-patient mismatch); malposition (either too high or too low)/malplacement – prosthetic valve migration/embolization • prosthetic valve endocarditis • prosthetic valve thrombosis • delivery catheter system malfunction resulting in the need for additional recrossing of the aortic valve and prolonged procedural time • delivery catheter system component embolization  • stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), or other neurological deficits • individual organ (e.g., cardiac, respiratory, renal [including acute kidney failure]) or multi-organ insufficiency or failure • major or minor bleeding that may require transfusion or intervention (including life-threatening or disabling bleeding) • vascular access-related complications (e.g., dissection, perforation, pain, bleeding, hematoma, pseudoaneurysm, irreversible nerve injury, compartment syndrome, arteriovenous fistula, or stenosis) • mitral valve regurgitation or injury • conduction system disturbances (e.g., atrioventricular node block, left bundle-branch block, asystole), which may require a permanent pacemaker • infection (including septicemia) • hypotension or hypertension • hemolysis • peripheral ischemia • General surgical risks applicable to transcatheter aortic valve implantation: • bowel ischemia • abnormal lab values (including electrolyte imbalance) • allergic reaction to antiplatelet agents, contrast medium, or anesthesia • exposure to radiation through fluoroscopy and angiography • permanent disability.

Please reference the Evolut PRO+, Evolut FX, and Evolut FX+ Instructions for Use for more information regarding indications, warnings, precautions, and potential adverse events.

Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician.

The commercial name of the Evolut™ PRO+ device is Medtronic Evolut™ PRO+ System, the commercial name of the Evolut™ FX device is Medtronic Evolut™ FX System, and the commercial name of the Evolut™ FX+ device is Medtronic Evolut™ FX+ System.

Angel Caldera, MD, interviews Paul Mahoney, MD, on TAV-in-SAV for failed bioprosthetic valves. They review patient selection, valve sizing, and coronary obstruction risk using CT planning. The discussion highlights leaflet modification, stroke considerations, anticoagulation strategies, and the ever-evolving balance between redo surgery and transcatheter approaches.

Indications

The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥8% at 30 days, based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Contraindications

Warnings

Precautions

—the degenerated TAV presents with a significant concomitant paravalvular leak (between the prosthesis and the native annulus),

—the degenerated TAV is not securely fixed in the native annulus, or is not structurally intact (for example, frame fracture) or

—the risk of coronary obstruction or sinus sequestration after Evolut PRO+, Evolut FX, or Evolut FX+ implantation is high. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in patient populations presenting with the following: Blood dyscrasias as defined as leukopenia (WBC < 1,000 cells/mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states; congenital unicuspid valve; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation [3-4+]); moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation; hypertrophic obstructive cardiomyopathy; new or untreated echocardiographic evidence of intracardiac mass, thrombus, or vegetation; native aortic annulus size < 18 mm or > 30 mm per the baseline diagnostic imaging or a surgical bioprosthetic or failed transcatheter aortic annulus size < 17 mm or > 30 mm; transarterial access unable to accommodate an 18 Fr introducer sheath or the 14 Fr equivalent Evolut PRO+ inline sheath when using model D-EVPROP2329US or Evolut FX Delivery Catheter System with inline sheath when using model D-EVOLUTFX-2329 or transarterial access unable to accommodate a 22 Fr introducer sheath or the 18 Fr equivalent Evolut PRO+ inline sheath when using model D-EVPROP34US or Evolut FX Delivery Catheter System with inline sheath when using model D-EVOLUTFX-34; prohibitive left ventricular outflow tract calcification; sinus of Valsalva anatomy that would prevent adequate coronary perfusion; significant aortopathy requiring ascending aortic replacement; moderate to severe mitral stenosis; severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%; symptomatic carotid or vertebral artery disease; and severe basal septal hypertrophy with an outflow gradient.

Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure to the vapors. Damage may result from forceful handling of the catheter. Prevent kinking of the catheter when removing it from the packaging. The bioprosthesis size must be appropriate to fit the patient’s anatomy. Proper sizing of the devices is the responsibility of the physician. Refer to the Instructions for Use for available sizes. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. Patients must present with transarterial access vessel diameters of ≥ 5 mm when using models D-EVPROP2329US/D-EVOLUTFX-2329 or ≥ 6 mm when using models D-EVPROP34US/D-EVOLUTFX-34, or patients must present with an ascending aortic (direct aortic) access site ≥ 60 mm from the basal plane for both systems. Implantation of the bioprosthesis should be avoided in patients with aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) of > 30° for right subclavian/axillary access or > 70° for femoral and left subclavian/axillary access. For subclavian/axillary access, patients with a patent left internal mammary artery (LIMA) graft must present with access vessel diameters that are either ≥ 5.5 mm when using models D-EVPROP2329US/D-EVOLUTFX-2329 or ≥ 6.5 mm when using models D-EVPROP34US/D-EVOLUTFX-34. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. For transfemoral access, use caution in patients who present with multiplanar curvature of the aorta, acute angulation of the aortic arch, an ascending aortic aneurysm, or severe calcification in the aorta and/or vasculature. If ≥ 2 of these factors are present, consider an alternative access route to prevent vascular complications. Limited clinical data are available for transcatheter aortic valve replacement in patients with a congenital bicuspid aortic valve who are deemed to be at low surgical risk. Anatomical characteristics should be considered when using the valve in this population. In addition, patient age should be considered as long-term durability of the valve has not been established.

During Use If a misload is detected during fluoroscopic inspection, do not attempt to reload the bioprosthesis. Discard the entire system. Inflow crown overlap that has not ended before the 4th node within the capsule increases the risk of an infold upon deployment in constrained anatomies, particularly with moderate-severe levels of calcification and/or bicuspid condition. Do not attempt to direct load the valve. After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. Excessive contrast media may cause renal failure. Prior to the procedure, measure the patient’s creatinine level. During the procedure, monitor contrast media usage. Conduct the procedure under fluoroscopy. Fluoroscopic procedures are associated with the risk of radiation damage to the skin, which may be painful, disfiguring, and long-term. For TAV in TAV procedures, failed valve size and patient anatomy must be considered before implantation of the Evolut PRO+, Evolut FX, or Evolut FX+ bioprosthesis to ensure patient safety (for example, to avoid coronary obstruction).

Potential adverse events

Potential risks associated with the implantation of the Evolut PRO+, Evolut FX, or Evolut FX+ transcatheter aortic valve may include, but are not limited to, the following: • death • myocardial infarction, cardiac arrest, cardiogenic shock, or cardiac tamponade • coronary occlusion, obstruction, or vessel spasm (including acute coronary closure) • cardiovascular injury (including rupture, perforation, tissue erosion, or dissection of vessels, ascending aorta trauma, ventricle, myocardium, or valvular structures that may require intervention) • emergent surgical or transcatheter intervention (e.g., coronary artery bypass, heart valve replacement, valve explant, percutaneous coronary intervention [PCI], balloon valvuloplasty) • prosthetic valve dysfunction (regurgitation or stenosis) due to fracture; bending (out-of-round configuration) of the valve frame; underexpansion of the valve frame; calcification; pannus; leaflet wear, tear, prolapse, or retraction; poor valve coaptation; suture breaks or disruption; leaks; mal-sizing (prosthesis-patient mismatch); malposition (either too high or too low)/malplacement – prosthetic valve migration/embolization • prosthetic valve endocarditis • prosthetic valve thrombosis • delivery catheter system malfunction resulting in the need for additional recrossing of the aortic valve and prolonged procedural time • delivery catheter system component embolization  • stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), or other neurological deficits • individual organ (e.g., cardiac, respiratory, renal [including acute kidney failure]) or multi-organ insufficiency or failure • major or minor bleeding that may require transfusion or intervention (including life-threatening or disabling bleeding) • vascular access-related complications (e.g., dissection, perforation, pain, bleeding, hematoma, pseudoaneurysm, irreversible nerve injury, compartment syndrome, arteriovenous fistula, or stenosis) • mitral valve regurgitation or injury • conduction system disturbances (e.g., atrioventricular node block, left bundle-branch block, asystole), which may require a permanent pacemaker • infection (including septicemia) • hypotension or hypertension • hemolysis • peripheral ischemia • General surgical risks applicable to transcatheter aortic valve implantation: • bowel ischemia • abnormal lab values (including electrolyte imbalance) • allergic reaction to antiplatelet agents, contrast medium, or anesthesia • exposure to radiation through fluoroscopy and angiography • permanent disability.

Please reference the Evolut PRO+, Evolut FX, and Evolut FX+ Instructions for Use for more information regarding indications, warnings, precautions, and potential adverse events.

Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician.

The commercial name of the Evolut™ PRO+ device is Medtronic Evolut™ PRO+ System, the commercial name of the Evolut™ FX device is Medtronic Evolut™ FX System, and the commercial name of the Evolut™ FX+ device is Medtronic Evolut™ FX+ System.

Dr. Lucas Seibolt and Dr. Rony Lahoud examine the complexities of treating bicuspid aortic valve disease in the TAVR era. This episode dives into anatomical considerations, procedural nuances, and emerging data—offering insights to help clinicians navigate one of the field’s most persistent challenges.

Indications

The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥8% at 30 days, based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Contraindications

Warnings

Precautions

—the degenerated TAV presents with a significant concomitant paravalvular leak (between the prosthesis and the native annulus),

—the degenerated TAV is not securely fixed in the native annulus, or is not structurally intact (for example, frame fracture) or

—the risk of coronary obstruction or sinus sequestration after Evolut PRO+, Evolut FX, or Evolut FX+ implantation is high. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in patient populations presenting with the following: Blood dyscrasias as defined as leukopenia (WBC < 1,000 cells/mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states; congenital unicuspid valve; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation [3-4+]); moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation; hypertrophic obstructive cardiomyopathy; new or untreated echocardiographic evidence of intracardiac mass, thrombus, or vegetation; native aortic annulus size < 18 mm or > 30 mm per the baseline diagnostic imaging or a surgical bioprosthetic or failed transcatheter aortic annulus size < 17 mm or > 30 mm; transarterial access unable to accommodate an 18 Fr introducer sheath or the 14 Fr equivalent Evolut PRO+ inline sheath when using model D-EVPROP2329US or Evolut FX Delivery Catheter System with inline sheath when using model D-EVOLUTFX-2329 or transarterial access unable to accommodate a 22 Fr introducer sheath or the 18 Fr equivalent Evolut PRO+ inline sheath when using model D-EVPROP34US or Evolut FX Delivery Catheter System with inline sheath when using model D-EVOLUTFX-34; prohibitive left ventricular outflow tract calcification; sinus of Valsalva anatomy that would prevent adequate coronary perfusion; significant aortopathy requiring ascending aortic replacement; moderate to severe mitral stenosis; severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%; symptomatic carotid or vertebral artery disease; and severe basal septal hypertrophy with an outflow gradient.

Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure to the vapors. Damage may result from forceful handling of the catheter. Prevent kinking of the catheter when removing it from the packaging. The bioprosthesis size must be appropriate to fit the patient’s anatomy. Proper sizing of the devices is the responsibility of the physician. Refer to the Instructions for Use for available sizes. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. Patients must present with transarterial access vessel diameters of ≥ 5 mm when using models D-EVPROP2329US/D-EVOLUTFX-2329 or ≥ 6 mm when using models D-EVPROP34US/D-EVOLUTFX-34, or patients must present with an ascending aortic (direct aortic) access site ≥ 60 mm from the basal plane for both systems. Implantation of the bioprosthesis should be avoided in patients with aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) of > 30° for right subclavian/axillary access or > 70° for femoral and left subclavian/axillary access. For subclavian/axillary access, patients with a patent left internal mammary artery (LIMA) graft must present with access vessel diameters that are either ≥ 5.5 mm when using models D-EVPROP2329US/D-EVOLUTFX-2329 or ≥ 6.5 mm when using models D-EVPROP34US/D-EVOLUTFX-34. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. For transfemoral access, use caution in patients who present with multiplanar curvature of the aorta, acute angulation of the aortic arch, an ascending aortic aneurysm, or severe calcification in the aorta and/or vasculature. If ≥ 2 of these factors are present, consider an alternative access route to prevent vascular complications. Limited clinical data are available for transcatheter aortic valve replacement in patients with a congenital bicuspid aortic valve who are deemed to be at low surgical risk. Anatomical characteristics should be considered when using the valve in this population. In addition, patient age should be considered as long-term durability of the valve has not been established.

During Use If a misload is detected during fluoroscopic inspection, do not attempt to reload the bioprosthesis. Discard the entire system. Inflow crown overlap that has not ended before the 4th node within the capsule increases the risk of an infold upon deployment in constrained anatomies, particularly with moderate-severe levels of calcification and/or bicuspid condition. Do not attempt to direct load the valve. After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. Excessive contrast media may cause renal failure. Prior to the procedure, measure the patient’s creatinine level. During the procedure, monitor contrast media usage. Conduct the procedure under fluoroscopy. Fluoroscopic procedures are associated with the risk of radiation damage to the skin, which may be painful, disfiguring, and long-term. For TAV in TAV procedures, failed valve size and patient anatomy must be considered before implantation of the Evolut PRO+, Evolut FX, or Evolut FX+ bioprosthesis to ensure patient safety (for example, to avoid coronary obstruction).

Potential adverse events

Potential risks associated with the implantation of the Evolut PRO+, Evolut FX, or Evolut FX+ transcatheter aortic valve may include, but are not limited to, the following: • death • myocardial infarction, cardiac arrest, cardiogenic shock, or cardiac tamponade • coronary occlusion, obstruction, or vessel spasm (including acute coronary closure) • cardiovascular injury (including rupture, perforation, tissue erosion, or dissection of vessels, ascending aorta trauma, ventricle, myocardium, or valvular structures that may require intervention) • emergent surgical or transcatheter intervention (e.g., coronary artery bypass, heart valve replacement, valve explant, percutaneous coronary intervention [PCI], balloon valvuloplasty) • prosthetic valve dysfunction (regurgitation or stenosis) due to fracture; bending (out-of-round configuration) of the valve frame; underexpansion of the valve frame; calcification; pannus; leaflet wear, tear, prolapse, or retraction; poor valve coaptation; suture breaks or disruption; leaks; mal-sizing (prosthesis-patient mismatch); malposition (either too high or too low)/malplacement – prosthetic valve migration/embolization • prosthetic valve endocarditis • prosthetic valve thrombosis • delivery catheter system malfunction resulting in the need for additional recrossing of the aortic valve and prolonged procedural time • delivery catheter system component embolization  • stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), or other neurological deficits • individual organ (e.g., cardiac, respiratory, renal [including acute kidney failure]) or multi-organ insufficiency or failure • major or minor bleeding that may require transfusion or intervention (including life-threatening or disabling bleeding) • vascular access-related complications (e.g., dissection, perforation, pain, bleeding, hematoma, pseudoaneurysm, irreversible nerve injury, compartment syndrome, arteriovenous fistula, or stenosis) • mitral valve regurgitation or injury • conduction system disturbances (e.g., atrioventricular node block, left bundle-branch block, asystole), which may require a permanent pacemaker • infection (including septicemia) • hypotension or hypertension • hemolysis • peripheral ischemia • General surgical risks applicable to transcatheter aortic valve implantation: • bowel ischemia • abnormal lab values (including electrolyte imbalance) • allergic reaction to antiplatelet agents, contrast medium, or anesthesia • exposure to radiation through fluoroscopy and angiography • permanent disability.

Please reference the Evolut PRO+, Evolut FX, and Evolut FX+ Instructions for Use for more information regarding indications, warnings, precautions, and potential adverse events.

Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician.

The commercial name of the Evolut™ PRO+ device is Medtronic Evolut™ PRO+ System, the commercial name of the Evolut™ FX device is Medtronic Evolut™ FX System, and the commercial name of the Evolut™ FX+ device is Medtronic Evolut™ FX+ System.

Join Sarah Kennedy and Jessica Kiszka as they explore best practices for optimizing post-TAVR care. From discharge planning to long-term follow-up, this episode highlights practical strategies to improve patient outcomes, streamline workflows, and support lifetime management in today’s evolving structural heart landscape.

Indications

The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥8% at 30 days, based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Contraindications

Warnings

Precautions

—the degenerated TAV presents with a significant concomitant paravalvular leak (between the prosthesis and the native annulus),

—the degenerated TAV is not securely fixed in the native annulus, or is not structurally intact (for example, frame fracture) or

—the risk of coronary obstruction or sinus sequestration after Evolut PRO+, Evolut FX, or Evolut FX+ implantation is high. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in patient populations presenting with the following: Blood dyscrasias as defined as leukopenia (WBC < 1,000 cells/mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states; congenital unicuspid valve; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation [3-4+]); moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation; hypertrophic obstructive cardiomyopathy; new or untreated echocardiographic evidence of intracardiac mass, thrombus, or vegetation; native aortic annulus size < 18 mm or > 30 mm per the baseline diagnostic imaging or a surgical bioprosthetic or failed transcatheter aortic annulus size < 17 mm or > 30 mm; transarterial access unable to accommodate an 18 Fr introducer sheath or the 14 Fr equivalent Evolut PRO+ inline sheath when using model D-EVPROP2329US or Evolut FX Delivery Catheter System with inline sheath when using model D-EVOLUTFX-2329 or transarterial access unable to accommodate a 22 Fr introducer sheath or the 18 Fr equivalent Evolut PRO+ inline sheath when using model D-EVPROP34US or Evolut FX Delivery Catheter System with inline sheath when using model D-EVOLUTFX-34; prohibitive left ventricular outflow tract calcification; sinus of Valsalva anatomy that would prevent adequate coronary perfusion; significant aortopathy requiring ascending aortic replacement; moderate to severe mitral stenosis; severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%; symptomatic carotid or vertebral artery disease; and severe basal septal hypertrophy with an outflow gradient.

Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure to the vapors. Damage may result from forceful handling of the catheter. Prevent kinking of the catheter when removing it from the packaging. The bioprosthesis size must be appropriate to fit the patient’s anatomy. Proper sizing of the devices is the responsibility of the physician. Refer to the Instructions for Use for available sizes. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. Patients must present with transarterial access vessel diameters of ≥ 5 mm when using models D-EVPROP2329US/D-EVOLUTFX-2329 or ≥ 6 mm when using models D-EVPROP34US/D-EVOLUTFX-34, or patients must present with an ascending aortic (direct aortic) access site ≥ 60 mm from the basal plane for both systems. Implantation of the bioprosthesis should be avoided in patients with aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) of > 30° for right subclavian/axillary access or > 70° for femoral and left subclavian/axillary access. For subclavian/axillary access, patients with a patent left internal mammary artery (LIMA) graft must present with access vessel diameters that are either ≥ 5.5 mm when using models D-EVPROP2329US/D-EVOLUTFX-2329 or ≥ 6.5 mm when using models D-EVPROP34US/D-EVOLUTFX-34. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. For transfemoral access, use caution in patients who present with multiplanar curvature of the aorta, acute angulation of the aortic arch, an ascending aortic aneurysm, or severe calcification in the aorta and/or vasculature. If ≥ 2 of these factors are present, consider an alternative access route to prevent vascular complications. Limited clinical data are available for transcatheter aortic valve replacement in patients with a congenital bicuspid aortic valve who are deemed to be at low surgical risk. Anatomical characteristics should be considered when using the valve in this population. In addition, patient age should be considered as long-term durability of the valve has not been established.

During Use If a misload is detected during fluoroscopic inspection, do not attempt to reload the bioprosthesis. Discard the entire system. Inflow crown overlap that has not ended before the 4th node within the capsule increases the risk of an infold upon deployment in constrained anatomies, particularly with moderate-severe levels of calcification and/or bicuspid condition. Do not attempt to direct load the valve. After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. Excessive contrast media may cause renal failure. Prior to the procedure, measure the patient’s creatinine level. During the procedure, monitor contrast media usage. Conduct the procedure under fluoroscopy. Fluoroscopic procedures are associated with the risk of radiation damage to the skin, which may be painful, disfiguring, and long-term. For TAV in TAV procedures, failed valve size and patient anatomy must be considered before implantation of the Evolut PRO+, Evolut FX, or Evolut FX+ bioprosthesis to ensure patient safety (for example, to avoid coronary obstruction).

Potential adverse events

Potential risks associated with the implantation of the Evolut PRO+, Evolut FX, or Evolut FX+ transcatheter aortic valve may include, but are not limited to, the following: • death • myocardial infarction, cardiac arrest, cardiogenic shock, or cardiac tamponade • coronary occlusion, obstruction, or vessel spasm (including acute coronary closure) • cardiovascular injury (including rupture, perforation, tissue erosion, or dissection of vessels, ascending aorta trauma, ventricle, myocardium, or valvular structures that may require intervention) • emergent surgical or transcatheter intervention (e.g., coronary artery bypass, heart valve replacement, valve explant, percutaneous coronary intervention [PCI], balloon valvuloplasty) • prosthetic valve dysfunction (regurgitation or stenosis) due to fracture; bending (out-of-round configuration) of the valve frame; underexpansion of the valve frame; calcification; pannus; leaflet wear, tear, prolapse, or retraction; poor valve coaptation; suture breaks or disruption; leaks; mal-sizing (prosthesis-patient mismatch); malposition (either too high or too low)/malplacement – prosthetic valve migration/embolization • prosthetic valve endocarditis • prosthetic valve thrombosis • delivery catheter system malfunction resulting in the need for additional recrossing of the aortic valve and prolonged procedural time • delivery catheter system component embolization  • stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), or other neurological deficits • individual organ (e.g., cardiac, respiratory, renal [including acute kidney failure]) or multi-organ insufficiency or failure • major or minor bleeding that may require transfusion or intervention (including life-threatening or disabling bleeding) • vascular access-related complications (e.g., dissection, perforation, pain, bleeding, hematoma, pseudoaneurysm, irreversible nerve injury, compartment syndrome, arteriovenous fistula, or stenosis) • mitral valve regurgitation or injury • conduction system disturbances (e.g., atrioventricular node block, left bundle-branch block, asystole), which may require a permanent pacemaker • infection (including septicemia) • hypotension or hypertension • hemolysis • peripheral ischemia • General surgical risks applicable to transcatheter aortic valve implantation: • bowel ischemia • abnormal lab values (including electrolyte imbalance) • allergic reaction to antiplatelet agents, contrast medium, or anesthesia • exposure to radiation through fluoroscopy and angiography • permanent disability.

Please reference the Evolut PRO+, Evolut FX, and Evolut FX+ Instructions for Use for more information regarding indications, warnings, precautions, and potential adverse events.

Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician.

The commercial name of the Evolut™ PRO+ device is Medtronic Evolut™ PRO+ System, the commercial name of the Evolut™ FX device is Medtronic Evolut™ FX System, and the commercial name of the Evolut™ FX+ device is Medtronic Evolut™ FX+ System.

In this episode, Dr. Kendra Grubb and Dr. Janine Eckstein take a closer look at the unique challenges faced by women with aortic stenosis (AS) and explore how transcatheter aortic valve replacement (TAVR) is transforming outcomes for female patients. They dive into the disparities in clinical outcomes between women undergoing surgical aortic valve replacement (SAVR) versus TAVR, and share their insights on how tailored approaches to care can help improve patient outcomes.

For additional context, check out this meta-analysis by Panoulas VF et al., which highlights how women have historically shown worse clinical outcomes with surgery compared to TAVR.

Tune in to hear Dr. Grubb and Dr. Eckstein’s perspectives on this important topic and learn how advancements in structural heart therapies are helping to address gender-specific challenges in treating AS.

Indications

The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥8% at 30 days, based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Contraindications

Warnings

Precautions

—the degenerated TAV presents with a significant concomitant paravalvular leak (between the prosthesis and the native annulus),

—the degenerated TAV is not securely fixed in the native annulus, or is not structurally intact (for example, frame fracture) or

—the risk of coronary obstruction or sinus sequestration after Evolut PRO+, Evolut FX, or Evolut FX+ implantation is high. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in patient populations presenting with the following: Blood dyscrasias as defined as leukopenia (WBC < 1,000 cells/mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states; congenital unicuspid valve; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation [3-4+]); moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation; hypertrophic obstructive cardiomyopathy; new or untreated echocardiographic evidence of intracardiac mass, thrombus, or vegetation; native aortic annulus size < 18 mm or > 30 mm per the baseline diagnostic imaging or a surgical bioprosthetic or failed transcatheter aortic annulus size < 17 mm or > 30 mm; transarterial access unable to accommodate an 18 Fr introducer sheath or the 14 Fr equivalent Evolut PRO+ inline sheath when using model D-EVPROP2329US or Evolut FX Delivery Catheter System with inline sheath when using model D-EVOLUTFX-2329 or transarterial access unable to accommodate a 22 Fr introducer sheath or the 18 Fr equivalent Evolut PRO+ inline sheath when using model D-EVPROP34US or Evolut FX Delivery Catheter System with inline sheath when using model D-EVOLUTFX-34; prohibitive left ventricular outflow tract calcification; sinus of Valsalva anatomy that would prevent adequate coronary perfusion; significant aortopathy requiring ascending aortic replacement; moderate to severe mitral stenosis; severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%; symptomatic carotid or vertebral artery disease; and severe basal septal hypertrophy with an outflow gradient.

Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure to the vapors. Damage may result from forceful handling of the catheter. Prevent kinking of the catheter when removing it from the packaging. The bioprosthesis size must be appropriate to fit the patient’s anatomy. Proper sizing of the devices is the responsibility of the physician. Refer to the Instructions for Use for available sizes. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. Patients must present with transarterial access vessel diameters of ≥ 5 mm when using models D-EVPROP2329US/D-EVOLUTFX-2329 or ≥ 6 mm when using models D-EVPROP34US/D-EVOLUTFX-34, or patients must present with an ascending aortic (direct aortic) access site ≥ 60 mm from the basal plane for both systems. Implantation of the bioprosthesis should be avoided in patients with aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) of > 30° for right subclavian/axillary access or > 70° for femoral and left subclavian/axillary access. For subclavian/axillary access, patients with a patent left internal mammary artery (LIMA) graft must present with access vessel diameters that are either ≥ 5.5 mm when using models D-EVPROP2329US/D-EVOLUTFX-2329 or ≥ 6.5 mm when using models D-EVPROP34US/D-EVOLUTFX-34. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. For transfemoral access, use caution in patients who present with multiplanar curvature of the aorta, acute angulation of the aortic arch, an ascending aortic aneurysm, or severe calcification in the aorta and/or vasculature. If ≥ 2 of these factors are present, consider an alternative access route to prevent vascular complications. Limited clinical data are available for transcatheter aortic valve replacement in patients with a congenital bicuspid aortic valve who are deemed to be at low surgical risk. Anatomical characteristics should be considered when using the valve in this population. In addition, patient age should be considered as long-term durability of the valve has not been established.

During Use If a misload is detected during fluoroscopic inspection, do not attempt to reload the bioprosthesis. Discard the entire system. Inflow crown overlap that has not ended before the 4th node within the capsule increases the risk of an infold upon deployment in constrained anatomies, particularly with moderate-severe levels of calcification and/or bicuspid condition. Do not attempt to direct load the valve. After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. Excessive contrast media may cause renal failure. Prior to the procedure, measure the patient’s creatinine level. During the procedure, monitor contrast media usage. Conduct the procedure under fluoroscopy. Fluoroscopic procedures are associated with the risk of radiation damage to the skin, which may be painful, disfiguring, and long-term. For TAV in TAV procedures, failed valve size and patient anatomy must be considered before implantation of the Evolut PRO+, Evolut FX, or Evolut FX+ bioprosthesis to ensure patient safety (for example, to avoid coronary obstruction).

Potential adverse events

Potential risks associated with the implantation of the Evolut PRO+, Evolut FX, or Evolut FX+ transcatheter aortic valve may include, but are not limited to, the following: • death • myocardial infarction, cardiac arrest, cardiogenic shock, or cardiac tamponade • coronary occlusion, obstruction, or vessel spasm (including acute coronary closure) • cardiovascular injury (including rupture, perforation, tissue erosion, or dissection of vessels, ascending aorta trauma, ventricle, myocardium, or valvular structures that may require intervention) • emergent surgical or transcatheter intervention (e.g., coronary artery bypass, heart valve replacement, valve explant, percutaneous coronary intervention [PCI], balloon valvuloplasty) • prosthetic valve dysfunction (regurgitation or stenosis) due to fracture; bending (out-of-round configuration) of the valve frame; underexpansion of the valve frame; calcification; pannus; leaflet wear, tear, prolapse, or retraction; poor valve coaptation; suture breaks or disruption; leaks; mal-sizing (prosthesis-patient mismatch); malposition (either too high or too low)/malplacement – prosthetic valve migration/embolization • prosthetic valve endocarditis • prosthetic valve thrombosis • delivery catheter system malfunction resulting in the need for additional recrossing of the aortic valve and prolonged procedural time • delivery catheter system component embolization  • stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), or other neurological deficits • individual organ (e.g., cardiac, respiratory, renal [including acute kidney failure]) or multi-organ insufficiency or failure • major or minor bleeding that may require transfusion or intervention (including life-threatening or disabling bleeding) • vascular access-related complications (e.g., dissection, perforation, pain, bleeding, hematoma, pseudoaneurysm, irreversible nerve injury, compartment syndrome, arteriovenous fistula, or stenosis) • mitral valve regurgitation or injury • conduction system disturbances (e.g., atrioventricular node block, left bundle-branch block, asystole), which may require a permanent pacemaker • infection (including septicemia) • hypotension or hypertension • hemolysis • peripheral ischemia • General surgical risks applicable to transcatheter aortic valve implantation: • bowel ischemia • abnormal lab values (including electrolyte imbalance) • allergic reaction to antiplatelet agents, contrast medium, or anesthesia • exposure to radiation through fluoroscopy and angiography • permanent disability.

Please reference the Evolut PRO+, Evolut FX, and Evolut FX+ Instructions for Use for more information regarding indications, warnings, precautions, and potential adverse events.

Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician.

The commercial name of the Evolut™ PRO+ device is Medtronic Evolut™ PRO+ System, the commercial name of the Evolut™ FX device is Medtronic Evolut™ FX System, and the commercial name of the Evolut™ FX+ device is Medtronic Evolut™ FX+ System.

In this episode of the Structural Heart Podcast: Luminaries Series, host Dr. Daniel O’Hair welcomes Dr. Daniel Spoon, a unique voice in the field of interventional cardiology, to discuss the often-overlooked mental stress faced by interventional cardiologists. The conversation delves into the high-pressure nature of cardiovascular interventions, where physicians must navigate unpredictable emergencies, long hours, and life-and-death situations—all while maintaining composure and precision. Dr. Spoon shares his unique journey from orthopedic surgery to interventional cardiology, highlighting the emotional and psychological demands of the profession and the strategies he has developed to manage them.

The discussion explores burnout, work-life balance, and the importance of mental resilience in sustaining a long and fulfilling career. Dr. Spoon draws from sports psychology principles to explain how managing stress, maintaining self-awareness, and fostering team cohesion can enhance performance and well-being. The episode also emphasizes the need for better mental health training in medical education, equipping future physicians with the tools to handle stress effectively. Ultimately, this episode serves as a candid and insightful reflection on the challenges of modern cardiology and the mindset required to thrive in this demanding field. UC202506521 EN.

Indications

The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥8% at 30 days, based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Contraindications

Warnings

Precautions

—the degenerated TAV presents with a significant concomitant paravalvular leak (between the prosthesis and the native annulus),

—the degenerated TAV is not securely fixed in the native annulus, or is not structurally intact (for example, frame fracture) or

—the risk of coronary obstruction or sinus sequestration after Evolut PRO+, Evolut FX, or Evolut FX+ implantation is high. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in patient populations presenting with the following: Blood dyscrasias as defined as leukopenia (WBC < 1,000 cells/mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states; congenital unicuspid valve; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation [3-4+]); moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation; hypertrophic obstructive cardiomyopathy; new or untreated echocardiographic evidence of intracardiac mass, thrombus, or vegetation; native aortic annulus size < 18 mm or > 30 mm per the baseline diagnostic imaging or a surgical bioprosthetic or failed transcatheter aortic annulus size < 17 mm or > 30 mm; transarterial access unable to accommodate an 18 Fr introducer sheath or the 14 Fr equivalent Evolut PRO+ inline sheath when using model D-EVPROP2329US or Evolut FX Delivery Catheter System with inline sheath when using model D-EVOLUTFX-2329 or transarterial access unable to accommodate a 22 Fr introducer sheath or the 18 Fr equivalent Evolut PRO+ inline sheath when using model D-EVPROP34US or Evolut FX Delivery Catheter System with inline sheath when using model D-EVOLUTFX-34; prohibitive left ventricular outflow tract calcification; sinus of Valsalva anatomy that would prevent adequate coronary perfusion; significant aortopathy requiring ascending aortic replacement; moderate to severe mitral stenosis; severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%; symptomatic carotid or vertebral artery disease; and severe basal septal hypertrophy with an outflow gradient.

Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure to the vapors. Damage may result from forceful handling of the catheter. Prevent kinking of the catheter when removing it from the packaging. The bioprosthesis size must be appropriate to fit the patient’s anatomy. Proper sizing of the devices is the responsibility of the physician. Refer to the Instructions for Use for available sizes. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. Patients must present with transarterial access vessel diameters of ≥ 5 mm when using models D-EVPROP2329US/D-EVOLUTFX-2329 or ≥ 6 mm when using models D-EVPROP34US/D-EVOLUTFX-34, or patients must present with an ascending aortic (direct aortic) access site ≥ 60 mm from the basal plane for both systems. Implantation of the bioprosthesis should be avoided in patients with aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) of > 30° for right subclavian/axillary access or > 70° for femoral and left subclavian/axillary access. For subclavian/axillary access, patients with a patent left internal mammary artery (LIMA) graft must present with access vessel diameters that are either ≥ 5.5 mm when using models D-EVPROP2329US/D-EVOLUTFX-2329 or ≥ 6.5 mm when using models D-EVPROP34US/D-EVOLUTFX-34. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. For transfemoral access, use caution in patients who present with multiplanar curvature of the aorta, acute angulation of the aortic arch, an ascending aortic aneurysm, or severe calcification in the aorta and/or vasculature. If ≥ 2 of these factors are present, consider an alternative access route to prevent vascular complications. Limited clinical data are available for transcatheter aortic valve replacement in patients with a congenital bicuspid aortic valve who are deemed to be at low surgical risk. Anatomical characteristics should be considered when using the valve in this population. In addition, patient age should be considered as long-term durability of the valve has not been established.

During Use If a misload is detected during fluoroscopic inspection, do not attempt to reload the bioprosthesis. Discard the entire system. Inflow crown overlap that has not ended before the 4th node within the capsule increases the risk of an infold upon deployment in constrained anatomies, particularly with moderate-severe levels of calcification and/or bicuspid condition. Do not attempt to direct load the valve. After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. Excessive contrast media may cause renal failure. Prior to the procedure, measure the patient’s creatinine level. During the procedure, monitor contrast media usage. Conduct the procedure under fluoroscopy. Fluoroscopic procedures are associated with the risk of radiation damage to the skin, which may be painful, disfiguring, and long-term. For TAV in TAV procedures, failed valve size and patient anatomy must be considered before implantation of the Evolut PRO+, Evolut FX, or Evolut FX+ bioprosthesis to ensure patient safety (for example, to avoid coronary obstruction).

Potential adverse events

Potential risks associated with the implantation of the Evolut PRO+, Evolut FX, or Evolut FX+ transcatheter aortic valve may include, but are not limited to, the following: • death • myocardial infarction, cardiac arrest, cardiogenic shock, or cardiac tamponade • coronary occlusion, obstruction, or vessel spasm (including acute coronary closure) • cardiovascular injury (including rupture, perforation, tissue erosion, or dissection of vessels, ascending aorta trauma, ventricle, myocardium, or valvular structures that may require intervention) • emergent surgical or transcatheter intervention (e.g., coronary artery bypass, heart valve replacement, valve explant, percutaneous coronary intervention [PCI], balloon valvuloplasty) • prosthetic valve dysfunction (regurgitation or stenosis) due to fracture; bending (out-of-round configuration) of the valve frame; underexpansion of the valve frame; calcification; pannus; leaflet wear, tear, prolapse, or retraction; poor valve coaptation; suture breaks or disruption; leaks; mal-sizing (prosthesis-patient mismatch); malposition (either too high or too low)/malplacement – prosthetic valve migration/embolization • prosthetic valve endocarditis • prosthetic valve thrombosis • delivery catheter system malfunction resulting in the need for additional recrossing of the aortic valve and prolonged procedural time • delivery catheter system component embolization  • stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), or other neurological deficits • individual organ (e.g., cardiac, respiratory, renal [including acute kidney failure]) or multi-organ insufficiency or failure • major or minor bleeding that may require transfusion or intervention (including life-threatening or disabling bleeding) • vascular access-related complications (e.g., dissection, perforation, pain, bleeding, hematoma, pseudoaneurysm, irreversible nerve injury, compartment syndrome, arteriovenous fistula, or stenosis) • mitral valve regurgitation or injury • conduction system disturbances (e.g., atrioventricular node block, left bundle-branch block, asystole), which may require a permanent pacemaker • infection (including septicemia) • hypotension or hypertension • hemolysis • peripheral ischemia • General surgical risks applicable to transcatheter aortic valve implantation: • bowel ischemia • abnormal lab values (including electrolyte imbalance) • allergic reaction to antiplatelet agents, contrast medium, or anesthesia • exposure to radiation through fluoroscopy and angiography • permanent disability.

Please reference the Evolut PRO+, Evolut FX, and Evolut FX+ Instructions for Use for more information regarding indications, warnings, precautions, and potential adverse events.

Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician.

The commercial name of the Evolut™ PRO+ device is Medtronic Evolut™ PRO+ System, the commercial name of the Evolut™ FX device is Medtronic Evolut™ FX System, and the commercial name of the Evolut™ FX+ device is Medtronic Evolut™ FX+ System.

Join hosts Dr. Dan O'Hair and Dr. Suzanne Baron in this compelling episode as they engage with esteemed guests Dr. Howard Herrmann and Dr. Michael Reardon, principal investigators of the SMART and Evolut Low Risk trials, respectively. 

Together, they explore the evolving landscape of structural heart interventions, analyzing groundbreaking data, clinical implications, and the future of patient care. From trial design to real-world applications, Dr. Herrmann and Dr. Reardon share firsthand insights into the science shaping tomorrow’s standards in cardiology.

Whether you're a clinician, researcher, or simply passionate about cardiovascular innovation, this episode delivers invaluable perspectives straight from the frontlines of clinical discovery.

Indications

The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥8% at 30 days, based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Contraindications

Warnings

Precautions

—the degenerated TAV presents with a significant concomitant paravalvular leak (between the prosthesis and the native annulus),

—the degenerated TAV is not securely fixed in the native annulus, or is not structurally intact (for example, frame fracture) or

—the risk of coronary obstruction or sinus sequestration after Evolut PRO+, Evolut FX, or Evolut FX+ implantation is high. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in patient populations presenting with the following: Blood dyscrasias as defined as leukopenia (WBC < 1,000 cells/mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states; congenital unicuspid valve; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation [3-4+]); moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation; hypertrophic obstructive cardiomyopathy; new or untreated echocardiographic evidence of intracardiac mass, thrombus, or vegetation; native aortic annulus size < 18 mm or > 30 mm per the baseline diagnostic imaging or a surgical bioprosthetic or failed transcatheter aortic annulus size < 17 mm or > 30 mm; transarterial access unable to accommodate an 18 Fr introducer sheath or the 14 Fr equivalent Evolut PRO+ inline sheath when using model D-EVPROP2329US or Evolut FX Delivery Catheter System with inline sheath when using model D-EVOLUTFX-2329 or transarterial access unable to accommodate a 22 Fr introducer sheath or the 18 Fr equivalent Evolut PRO+ inline sheath when using model D-EVPROP34US or Evolut FX Delivery Catheter System with inline sheath when using model D-EVOLUTFX-34; prohibitive left ventricular outflow tract calcification; sinus of Valsalva anatomy that would prevent adequate coronary perfusion; significant aortopathy requiring ascending aortic replacement; moderate to severe mitral stenosis; severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%; symptomatic carotid or vertebral artery disease; and severe basal septal hypertrophy with an outflow gradient.

Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure to the vapors. Damage may result from forceful handling of the catheter. Prevent kinking of the catheter when removing it from the packaging. The bioprosthesis size must be appropriate to fit the patient’s anatomy. Proper sizing of the devices is the responsibility of the physician. Refer to the Instructions for Use for available sizes. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. Patients must present with transarterial access vessel diameters of ≥ 5 mm when using models D-EVPROP2329US/D-EVOLUTFX-2329 or ≥ 6 mm when using models D-EVPROP34US/D-EVOLUTFX-34, or patients must present with an ascending aortic (direct aortic) access site ≥ 60 mm from the basal plane for both systems. Implantation of the bioprosthesis should be avoided in patients with aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) of > 30° for right subclavian/axillary access or > 70° for femoral and left subclavian/axillary access. For subclavian/axillary access, patients with a patent left internal mammary artery (LIMA) graft must present with access vessel diameters that are either ≥ 5.5 mm when using models D-EVPROP2329US/D-EVOLUTFX-2329 or ≥ 6.5 mm when using models D-EVPROP34US/D-EVOLUTFX-34. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. For transfemoral access, use caution in patients who present with multiplanar curvature of the aorta, acute angulation of the aortic arch, an ascending aortic aneurysm, or severe calcification in the aorta and/or vasculature. If ≥ 2 of these factors are present, consider an alternative access route to prevent vascular complications. Limited clinical data are available for transcatheter aortic valve replacement in patients with a congenital bicuspid aortic valve who are deemed to be at low surgical risk. Anatomical characteristics should be considered when using the valve in this population. In addition, patient age should be considered as long-term durability of the valve has not been established.

During Use If a misload is detected during fluoroscopic inspection, do not attempt to reload the bioprosthesis. Discard the entire system. Inflow crown overlap that has not ended before the 4th node within the capsule increases the risk of an infold upon deployment in constrained anatomies, particularly with moderate-severe levels of calcification and/or bicuspid condition. Do not attempt to direct load the valve. After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. Excessive contrast media may cause renal failure. Prior to the procedure, measure the patient’s creatinine level. During the procedure, monitor contrast media usage. Conduct the procedure under fluoroscopy. Fluoroscopic procedures are associated with the risk of radiation damage to the skin, which may be painful, disfiguring, and long-term. For TAV in TAV procedures, failed valve size and patient anatomy must be considered before implantation of the Evolut PRO+, Evolut FX, or Evolut FX+ bioprosthesis to ensure patient safety (for example, to avoid coronary obstruction).

Potential adverse events

Potential risks associated with the implantation of the Evolut PRO+, Evolut FX, or Evolut FX+ transcatheter aortic valve may include, but are not limited to, the following: • death • myocardial infarction, cardiac arrest, cardiogenic shock, or cardiac tamponade • coronary occlusion, obstruction, or vessel spasm (including acute coronary closure) • cardiovascular injury (including rupture, perforation, tissue erosion, or dissection of vessels, ascending aorta trauma, ventricle, myocardium, or valvular structures that may require intervention) • emergent surgical or transcatheter intervention (e.g., coronary artery bypass, heart valve replacement, valve explant, percutaneous coronary intervention [PCI], balloon valvuloplasty) • prosthetic valve dysfunction (regurgitation or stenosis) due to fracture; bending (out-of-round configuration) of the valve frame; underexpansion of the valve frame; calcification; pannus; leaflet wear, tear, prolapse, or retraction; poor valve coaptation; suture breaks or disruption; leaks; mal-sizing (prosthesis-patient mismatch); malposition (either too high or too low)/malplacement – prosthetic valve migration/embolization • prosthetic valve endocarditis • prosthetic valve thrombosis • delivery catheter system malfunction resulting in the need for additional recrossing of the aortic valve and prolonged procedural time • delivery catheter system component embolization  • stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), or other neurological deficits • individual organ (e.g., cardiac, respiratory, renal [including acute kidney failure]) or multi-organ insufficiency or failure • major or minor bleeding that may require transfusion or intervention (including life-threatening or disabling bleeding) • vascular access-related complications (e.g., dissection, perforation, pain, bleeding, hematoma, pseudoaneurysm, irreversible nerve injury, compartment syndrome, arteriovenous fistula, or stenosis) • mitral valve regurgitation or injury • conduction system disturbances (e.g., atrioventricular node block, left bundle-branch block, asystole), which may require a permanent pacemaker • infection (including septicemia) • hypotension or hypertension • hemolysis • peripheral ischemia • General surgical risks applicable to transcatheter aortic valve implantation: • bowel ischemia • abnormal lab values (including electrolyte imbalance) • allergic reaction to antiplatelet agents, contrast medium, or anesthesia • exposure to radiation through fluoroscopy and angiography • permanent disability.

Please reference the Evolut PRO+, Evolut FX, and Evolut FX+ Instructions for Use for more information regarding indications, warnings, precautions, and potential adverse events.

Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician.

The commercial name of the Evolut™ PRO+ device is Medtronic Evolut™ PRO+ System, the commercial name of the Evolut™ FX device is Medtronic Evolut™ FX System, and the commercial name of the Evolut™ FX+ device is Medtronic Evolut™ FX+ System.