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Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients
Deeb, G. 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Scott, McDaniel, Sharon S., Pack, Angelina, White, Wendi, Young, Travis S. , Burgess, Pam, Pu, Min , Upadhya, Bharathi , Applegate, Robert J., Kon, Neal D., Arnan, Martinson, Baghshomali, Sanam, Bishop, L. R., Bradbury, Edward, Gandhi, Sanjay , Kincaid, Edward H., Lefkowitz, David , Lisle, Benjamin, Batteria, Melissa, Rerisi, Elizabeth, Stepinowski, Kimberly, Senicola, Tanya, Goncalves, John, Schubach, Scott , Schwartz, Richard, Antaky, Karin, Christiansen, C, Marzo, Kevin , Michel, Kathleen, Varghese, Princy , Wirkowski, Elizieta, Lévesque, Linda E. , Cleman, Michael , Forrest, John K. , Hashim, Sabet, Mangi, Abeel A. , Amin, Hardick, Darr, Umer, Dewar, Michael, Faheem, Osman, Geirsson, Arnar , Kaleel, Abdel Salam, Kaple, Ryan , Lansky, Alexandra, Grory, Brian Mac, Pfau, Steven , Schindler, Joseph , Yuh, David D., Serruys, Patrick W , Limaye, Kaustubh , Windecker, Stephan , Reardon, Michael J , Bode, Felix J , Mieghem, Nicolas M. 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Scott , Ng, Ken, Bates, Michael, Grey, William, Rose, Geoffrey, Scherer, Markus, Martin, Jerry, Cheng, Wen, Kar, Saibal , Mody, Cyrus, Ramzy, Danny , Sohn, Jeanie, Hahn, Rebecca T , Contreras, Jose Gutierrez, Kummer, Benjamin R. , Miller, Eliza C. , Nazif, Tamim , Qureshi, Abid, Rostanski, Sara , Willey, Joshua , Yaghi, Shadi , Rosenbloom, Michael, Schell, Wendy, Huang, Hong , Ali, Omar, Henry, Scott, Bleiziffer, Sabine , Hengstenberg, Christian , Brenner, Susanne, Kasel, Albert Markus , Kreuzpointner, Robert , Poppert, Holger , Seifert, Christian, Voß, Bernhard , Cowhig, Dahlia, Newbold, Stephanie, Velazquez, Eric J. , Harrison, J. Kevin, Hughes, George Chad , Ali, Yasmin, Gokhale, Sankalp , Hendry, Robert, Hernandez, Christian, Klein, Michael, Kolls, Brad J. , Maldonado, Andres M. 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JAMA Cardiology | August 24, 2022 | Volume: 7 | Issue: 10 | Pages: 1000
Importance In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited. Objective To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. Design, Setting, and Participants SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021. Intervention Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis. Main Outcomes and Measures The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years. Results A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P < .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm 2 vs 1.8 [0.6] cm 2 ; P < .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P < .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention. Conclusions and Relevance Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.
Carotid access for transcatheter aortic valve replacement: A meta‐analysis
Sharma, Sharan Prakash , Ghuneim, Angela, Harder, William, David, Shukri , Choksi, Nishit, Kondur, Snigdha, Kambhatla, Swathi, Kambhatla, Sujata, Kondur, Ashok , Sharma, Sharan Prakash , Chaudhary, Rahul
Catheterization and Cardiovascular Interventions | September 5, 2020 | Volume: 97 | Issue: 4 | Pages: 723-733
AbstractObjectiveWe sought to evaluate the feasibility and safety of carotid access transcatheter aortic valve replacement (TAVR) by performing a meta‐analysis of published cases.BackgroundSeveral case series and regional data have provided initial basis for carotid access TAVR in patients with prohibitive femoral approach. We performed this meta‐analysis to provide further evidence of feasibility and safety of carotid TAVR.MethodsWe searched PubMed, EMBASE, CINAHL, and Cochrane CENTRAL for any study on carotid access TAVR involving ⩾5 patients since inception till March 1, 2020. Random‐effects model was used to compute overall effects. The outcomes analyzed were all‐cause mortality, Transient ischemic attack (TIA)/stroke, need for permanent pacemaker (PPM) implantation, pericardial tamponade, access site complications, major bleeding, and length of stay.ResultsThere was a total of 17 retrospective studies (n = 2082) with a median follow‐up of 1 month. Mean age of the patient was 80 years. Mean Euroscore and STS scores were 15 ± 6.2 and 7.9 ± 3.3, respectively. The procedural success rate was 99%. The rate of all‐cause mortality was 6.7% (range 4.6–9.7%, p < .001, I2 = 67%). Incidence of TIA/stroke was 3.9% (range 3.1–4.8%, p < .001, I2 = 0%) and PPM implantation was 16.7% (range 12.5–21.9%, p < .001, I2 = 56%). Rate of pericardial tamponade, vascular complication, and major bleeding were 1.7, 2.5, and 7%, respectively. Average length of hospital stay was 7.7 days.ConclusionOur results show that transcarotid approach is a feasible option in patients with prohibitive femoral access for TAVR.