Luminaries in Structural Heart

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The Luminaries in Structural Heart podcast offers an inside look at the people shaping the future of cardiology. Through engaging and thoughtful conversations, the series explores each guest’s personal journey, academic milestones, and perspectives on the most relevant and timely topics in contemporary invasive cardiology. Hosted by distinguished cardiac surgeons and interventional cardiologists with deep expertise in structural heart interventions, the podcast delivers meaningful dialogue, global insights, and expert commentary from some of the field’s most influential voices.

  1. Oct 22

    HALT and Thrombosis After TAVR: What Is Really Happening?

    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 relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. 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 The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are contraindicated in patients who cannot tolerate Nitinol (titanium or nickel), gold (for Evolut FX and Evolut FX+ Systems alone), an anticoagulation/antiplatelet regimen, or who have active bacterial endocarditis or other active infections. Warnings General Implantation of the Evolut PRO+, Evolut FX, and Evolut FX+ Systems should be performed only by physicians who have received Medtronic Evolut PRO+, Evolut FX, or Evolut FX+ training. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. Transcatheter aortic valve (bioprosthesis) Accelerated deterioration due to calcific degeneration of the bioprostheses may occur in: children, adolescents, or young adults; patients with altered calcium metabolism (e.g., chronic renal failure or hyperthyroidism). Precautions General Clinical long-term durability has not been established for the bioprosthesis. Evaluate bioprosthesis performance as needed during patient follow-up. The safety and effectiveness of the Evolut PRO+, Evolut FX, and Evolut FX+ Systems have not been evaluated in the pediatric population. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in the following patient populations: Patients who do not meet the criteria for symptomatic severe native aortic stenosis as defined: (1) symptomatic severe high-gradient aortic stenosis — aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient ≥ 40 mm Hg, or a peak aortic-jet velocity ≥ 4.0 m/s; (2) symptomatic severe low-flow, low-gradient aortic stenosis — aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient 30 mm per the baseline diagnostic imaging or a surgical bioprosthetic or failed transcatheter aortic annulus size 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) 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.

  2. Sep 28

    Early Career Growth & Leadership

    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 relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. 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 The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are contraindicated in patients who cannot tolerate Nitinol (titanium or nickel), gold (for Evolut FX and Evolut FX+ Systems alone), an anticoagulation/antiplatelet regimen, or who have active bacterial endocarditis or other active infections. Warnings General Implantation of the Evolut PRO+, Evolut FX, and Evolut FX+ Systems should be performed only by physicians who have received Medtronic Evolut PRO+, Evolut FX, or Evolut FX+ training. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. Transcatheter aortic valve (bioprosthesis) Accelerated deterioration due to calcific degeneration of the bioprostheses may occur in: children, adolescents, or young adults; patients with altered calcium metabolism (e.g., chronic renal failure or hyperthyroidism). Precautions General Clinical long-term durability has not been established for the bioprosthesis. Evaluate bioprosthesis performance as needed during patient follow-up. The safety and effectiveness of the Evolut PRO+, Evolut FX, and Evolut FX+ Systems have not been evaluated in the pediatric population. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in the following patient populations: Patients who do not meet the criteria for symptomatic severe native aortic stenosis as defined: (1) symptomatic severe high-gradient aortic stenosis — aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient ≥ 40 mm Hg, or a peak aortic-jet velocity ≥ 4.0 m/s; (2) symptomatic severe low-flow, low-gradient aortic stenosis — aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient 30 mm per the baseline diagnostic imaging or a surgical bioprosthetic or failed transcatheter aortic annulus size 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) 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.

  3. Sep 21

    Coronary Cannulation and Access Strategies After TAVR

    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 relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. 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 The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are contraindicated in patients who cannot tolerate Nitinol (titanium or nickel), gold (for Evolut FX and Evolut FX+ Systems alone), an anticoagulation/antiplatelet regimen, or who have active bacterial endocarditis or other active infections. Warnings General Implantation of the Evolut PRO+, Evolut FX, and Evolut FX+ Systems should be performed only by physicians who have received Medtronic Evolut PRO+, Evolut FX, or Evolut FX+ training. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. Transcatheter aortic valve (bioprosthesis) Accelerated deterioration due to calcific degeneration of the bioprostheses may occur in: children, adolescents, or young adults; patients with altered calcium metabolism (e.g., chronic renal failure or hyperthyroidism). Precautions General Clinical long-term durability has not been established for the bioprosthesis. Evaluate bioprosthesis performance as needed during patient follow-up. The safety and effectiveness of the Evolut PRO+, Evolut FX, and Evolut FX+ Systems have not been evaluated in the pediatric population. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in the following patient populations: Patients who do not meet the criteria for symptomatic severe native aortic stenosis as defined: (1) symptomatic severe high-gradient aortic stenosis — aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient ≥ 40 mm Hg, or a peak aortic-jet velocity ≥ 4.0 m/s; (2) symptomatic severe low-flow, low-gradient aortic stenosis — aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient 30 mm per the baseline diagnostic imaging or a surgical bioprosthetic or failed transcatheter aortic annulus size 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) 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.

  4. Aug 13

    Does SMART Translate? A Real-World Look at Small-Annulus TAVR

    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 relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. 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 The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are contraindicated in patients who cannot tolerate Nitinol (titanium or nickel), gold (for Evolut FX and Evolut FX+ Systems alone), an anticoagulation/antiplatelet regimen, or who have active bacterial endocarditis or other active infections. Warnings General Implantation of the Evolut PRO+, Evolut FX, and Evolut FX+ Systems should be performed only by physicians who have received Medtronic Evolut PRO+, Evolut FX, or Evolut FX+ training. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. Transcatheter aortic valve (bioprosthesis) Accelerated deterioration due to calcific degeneration of the bioprostheses may occur in: children, adolescents, or young adults; patients with altered calcium metabolism (e.g., chronic renal failure or hyperthyroidism). Precautions General Clinical long-term durability has not been established for the bioprosthesis. Evaluate bioprosthesis performance as needed during patient follow-up. The safety and effectiveness of the Evolut PRO+, Evolut FX, and Evolut FX+ Systems have not been evaluated in the pediatric population. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in the following patient populations: Patients who do not meet the criteria for symptomatic severe native aortic stenosis as defined: (1) symptomatic severe high-gradient aortic stenosis — aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient ≥ 40 mm Hg, or a peak aortic-jet velocity ≥ 4.0 m/s; (2) symptomatic severe low-flow, low-gradient aortic stenosis — aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient 30 mm per the baseline diagnostic imaging or a surgical bioprosthetic or failed transcatheter aortic annulus size 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) 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 o

  5. Jun 22

    TAV-in-SAV: Techniques, Sizing, and Outcomes

    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 relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. 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 The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are contraindicated in patients who cannot tolerate Nitinol (titanium or nickel), gold (for Evolut FX and Evolut FX+ Systems alone), an anticoagulation/antiplatelet regimen, or who have active bacterial endocarditis or other active infections. Warnings General Implantation of the Evolut PRO+, Evolut FX, and Evolut FX+ Systems should be performed only by physicians who have received Medtronic Evolut PRO+, Evolut FX, or Evolut FX+ training. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. Transcatheter aortic valve (bioprosthesis) Accelerated deterioration due to calcific degeneration of the bioprostheses may occur in: children, adolescents, or young adults; patients with altered calcium metabolism (e.g., chronic renal failure or hyperthyroidism). Precautions General Clinical long-term durability has not been established for the bioprosthesis. Evaluate bioprosthesis performance as needed during patient follow-up. The safety and effectiveness of the Evolut PRO+, Evolut FX, and Evolut FX+ Systems have not been evaluated in the pediatric population. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in the following patient populations: Patients who do not meet the criteria for symptomatic severe native aortic stenosis as defined: (1) symptomatic severe high-gradient aortic stenosis — aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient ≥ 40 mm Hg, or a peak aortic-jet velocity ≥ 4.0 m/s; (2) symptomatic severe low-flow, low-gradient aortic stenosis — aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient 30 mm per the baseline diagnostic imaging or a surgical bioprosthetic or failed transcatheter aortic annulus size 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) 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.

  6. Mar 9

    Why is bicuspid still a challenge? ft. Lucas Seibolt, MD and Rony Lahoud, MD

    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 relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. 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 The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are contraindicated in patients who cannot tolerate Nitinol (titanium or nickel), gold (for Evolut FX and Evolut FX+ Systems alone), an anticoagulation/antiplatelet regimen, or who have active bacterial endocarditis or other active infections. Warnings General Implantation of the Evolut PRO+, Evolut FX, and Evolut FX+ Systems should be performed only by physicians who have received Medtronic Evolut PRO+, Evolut FX, or Evolut FX+ training. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. Transcatheter aortic valve (bioprosthesis) Accelerated deterioration due to calcific degeneration of the bioprostheses may occur in: children, adolescents, or young adults; patients with altered calcium metabolism (e.g., chronic renal failure or hyperthyroidism). Precautions General Clinical long-term durability has not been established for the bioprosthesis. Evaluate bioprosthesis performance as needed during patient follow-up. The safety and effectiveness of the Evolut PRO+, Evolut FX, and Evolut FX+ Systems have not been evaluated in the pediatric population. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in the following patient populations: Patients who do not meet the criteria for symptomatic severe native aortic stenosis as defined: (1) symptomatic severe high-gradient aortic stenosis — aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient ≥ 40 mm Hg, or a peak aortic-jet velocity ≥ 4.0 m/s; (2) symptomatic severe low-flow, low-gradient aortic stenosis — aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient 30 mm per the baseline diagnostic imaging or a surgical bioprosthetic or failed transcatheter aortic annulus size 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) 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.

  7. Mar 9

    Post-TAVR Optimization ft. Sarah Kennedy, NP and Jessica Kiska, NP

    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 relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. 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 The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are contraindicated in patients who cannot tolerate Nitinol (titanium or nickel), gold (for Evolut FX and Evolut FX+ Systems alone), an anticoagulation/antiplatelet regimen, or who have active bacterial endocarditis or other active infections. Warnings General Implantation of the Evolut PRO+, Evolut FX, and Evolut FX+ Systems should be performed only by physicians who have received Medtronic Evolut PRO+, Evolut FX, or Evolut FX+ training. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. Transcatheter aortic valve (bioprosthesis) Accelerated deterioration due to calcific degeneration of the bioprostheses may occur in: children, adolescents, or young adults; patients with altered calcium metabolism (e.g., chronic renal failure or hyperthyroidism). Precautions General Clinical long-term durability has not been established for the bioprosthesis. Evaluate bioprosthesis performance as needed during patient follow-up. The safety and effectiveness of the Evolut PRO+, Evolut FX, and Evolut FX+ Systems have not been evaluated in the pediatric population. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in the following patient populations: Patients who do not meet the criteria for symptomatic severe native aortic stenosis as defined: (1) symptomatic severe high-gradient aortic stenosis — aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient ≥ 40 mm Hg, or a peak aortic-jet velocity ≥ 4.0 m/s; (2) symptomatic severe low-flow, low-gradient aortic stenosis — aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient 30 mm per the baseline diagnostic imaging or a surgical bioprosthetic or failed transcatheter aortic annulus size 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) 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.

  8. 11/07/2025

    Breaking Barriers: Women with AS – A Conversation with Dr. Kendra Grubb and Dr. Janine Eckstein

    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 relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. 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 The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are contraindicated in patients who cannot tolerate Nitinol (titanium or nickel), gold (for Evolut FX and Evolut FX+ Systems alone), an anticoagulation/antiplatelet regimen, or who have active bacterial endocarditis or other active infections. Warnings General Implantation of the Evolut PRO+, Evolut FX, and Evolut FX+ Systems should be performed only by physicians who have received Medtronic Evolut PRO+, Evolut FX, or Evolut FX+ training. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. Transcatheter aortic valve (bioprosthesis) Accelerated deterioration due to calcific degeneration of the bioprostheses may occur in: children, adolescents, or young adults; patients with altered calcium metabolism (e.g., chronic renal failure or hyperthyroidism). Precautions General Clinical long-term durability has not been established for the bioprosthesis. Evaluate bioprosthesis performance as needed during patient follow-up. The safety and effectiveness of the Evolut PRO+, Evolut FX, and Evolut FX+ Systems have not been evaluated in the pediatric population. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in the following patient populations: Patients who do not meet the criteria for symptomatic severe native aortic stenosis as defined: (1) symptomatic severe high-gradient aortic stenosis — aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient ≥ 40 mm Hg, or a peak aortic-jet velocity ≥ 4.0 m/s; (2) symptomatic severe low-flow, low-gradient aortic stenosis — aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient 30 mm per the baseline diagnostic imaging or a surgical bioprosthetic or failed transcatheter aortic annulus size 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) 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. Cautio

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