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Three-year outcomes with a contemporary self-expanding transcatheter valve from the Evolut PRO US Clinical Study

Wyler von Ballmoos, Moritz C; Reardon, Michael J; Williams, Mathew R; Mangi, Abeel A; Kleiman, Neal S; Yakubov, Steven J; Watson, Daniel; Kodali, Susheel; George, Isaac; Tadros, Peter; Zorn, George L; Brown, John; Kipperman, Robert; Oh, Jae K; Qiao, Hongyan; Forrest, John K
BACKGROUND:Paravalvular regurgitation (PVR) following transcatheter aortic valve replacement (TAVR) is associated with increased morbidity and mortality. PVR continues to plague TAVR jeopardizing long-term results. New device iterations, such as the self-expandable Evolut PRO valve, aim to decrease PVR while maintaining optimal hemodynamics. This study sought to evaluate clinical and hemodynamic performance of the Evolut PRO system at 3 years. METHODS:The Evolut PRO US Clinical Study included 60 patients at high or extreme surgical risk undergoing TAVR with the Evolut PRO valve at 8 centers in the United States. Clinical outcomes were evaluated using Valve Academic Research Consortium (VARC)-2 criteria and included all-cause mortality, cardiovascular mortality, disabling stroke and valve complications. An independent core laboratory centrally assessed all echocardiographic measures. RESULTS:, and 88.2% of patients had no or trace PVR. The remaining patients had mild PVR. Most of the surviving patients (80.6%) had New York Heart Association class I symptoms at 3 years. CONCLUSION/CONCLUSIONS:Outcomes at 3-years following TAVR with a contemporary self-expanding prosthesis are favorable, with no signal of valve deterioration, excellent hemodynamics including very low prevalence of PVR.
PMID: 33199247
ISSN: 1878-0938
CID: 4684412

Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk

Leon, Martin B; Mack, Michael J; Hahn, Rebecca T; Thourani, Vinod H; Makkar, Raj; Kodali, Susheel K; Alu, Maria C; Madhavan, Mahesh V; Chau, Katherine H; Russo, Mark; Kapadia, Samir R; Malaisrie, S Chris; Cohen, David J; Blanke, Philipp; Leipsic, Jonathon A; Williams, Mathew R; McCabe, James M; Brown, David L; Babaliaros, Vasilis; Goldman, Scott; Herrmann, Howard C; Szeto, Wilson Y; Genereux, Philippe; Pershad, Ashish; Lu, Michael; Webb, John G; Smith, Craig R; Pibarot, Philippe
BACKGROUND:In low surgical risk patients with symptomatic severe aortic stenosis, the PARTNER 3 (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis) trial demonstrated superiority of transcatheter aortic valve replacement (TAVR) versus surgery for the primary endpoint of death, stroke, or re-hospitalization at 1 year. OBJECTIVES/OBJECTIVE:This study determined both clinical and echocardiographic outcomes between 1 and 2 years in the PARTNER 3 trial. METHODS:This study randomly assigned 1,000 patients (1:1) to transfemoral TAVR with the SAPIEN 3 valve versus surgery (mean Society of Thoracic Surgeons score: 1.9%; mean age: 73 years) with clinical and echocardiography follow-up at 30 days and at 1 and 2 years. This study assessed 2-year rates of the primary endpoint and several secondary endpoints (clinical, echocardiography, and quality-of-life measures) in this as-treated analysis. RESULTS:Primary endpoint follow-up at 2 years was available in 96.5% of patients. The 2-year primary endpoint was significantly reduced after TAVR versus surgery (11.5% vs. 17.4%; hazard ratio: 0.63; 95% confidence interval: 0.45 to 0.88; p = 0.007). Differences in death and stroke favoring TAVR at 1 year were not statistically significant at 2 years (death: TAVR 2.4% vs. surgery 3.2%; p = 0.47; stroke: TAVR 2.4% vs. surgery 3.6%; p = 0.28). Valve thrombosis at 2 years was increased after TAVR (2.6%; 13 events) compared with surgery (0.7%; 3 events; p = 0.02). Disease-specific health status continued to be better after TAVR versus surgery through 2 years. Echocardiographic findings, including hemodynamic valve deterioration and bioprosthetic valve failure, were similar for TAVR and surgery at 2 years. CONCLUSIONS:At 2 years, the primary endpoint remained significantly lower with TAVR versus surgery, but initial differences in death and stroke favoring TAVR were diminished and patients who underwent TAVR had increased valve thrombosis. (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [PARTNER 3]; NCT02675114).
PMID: 33663731
ISSN: 1558-3597
CID: 4806972

Progression of Tricuspid Regurgitation After Surgery for Ischemic Mitral Regurgitation

Bertrand, Philippe B; Overbey, Jessica R; Zeng, Xin; Levine, Robert A; Ailawadi, Gorav; Acker, Michael A; Smith, Peter K; Thourani, Vinod H; Bagiella, Emilia; Miller, Marissa A; Gupta, Lopa; Mack, Michael J; Gillinov, A Marc; Giustino, Gennaro; Moskowitz, Alan J; Gelijns, Annetine C; Bowdish, Michael E; O'Gara, Patrick T; Gammie, James S; Hung, Judy; Miller, Marissa A; Taddei-Peters, Wendy C; Buxton, Dennis; Caulder, Ron; Geller, Nancy L; Gordon, David; Jeffries, Neal O; Lee, Albert; Moy, Claudia S; Gombos, Ilana Kogan; Ralph, Jennifer; Weisel, Richard D; Gardner, Timothy J; O'Gara, Patrick T; Rose, Eric A; Gelijns, Annetine C; Parides, Michael K; Ascheim, Deborah D; Moskowitz, Alan J; Bagiella, Emilia; Moquete, Ellen; Chang, Helena; Chase, Melissa; Foo, James; Chen, Yingchun; Goldfarb, Seth; Gupta, Lopa; Kirkwood, Katherine; Dobrev, Edlira; Levitan, Ron; O'Sullivan, Karen; Overbey, Jessica; Santos, Milerva; Williams, Deborah; Weglinski, Michael; Williams, Paula; Wood, Carrie; Ye, Xia; Nielsen, Sten Lyager; Wiggers, Henrik; Malgaard, Henning; Mack, Michael; Adame, Tracine; Settele, Natalie; Adams, Jenny; Ryan, William; Smith, Robert L; Grayburn, Paul; Chen, Frederick Y; Nohria, Anju; Cohn, Lawrence; Shekar, Prem; Aranki, Sary; Couper, Gregory; Davidson, Michael; Bolman, R Morton 3rd; Burgess, Anne; Conboy, Debra; Lawrence, Rita; Noiseux, Nicolas; Stevens, Louis-Mathieu; Prieto, Ignacio; Basile, Fadi; Dionne, Joannie; Fecteau, Julie; Blackstone, Eugene H; Gillinov, A Marc; Lackner, Pamela; Berroteran, Leoma; Dolney, Diana; Fleming, Suzanne; Palumbo, Roberta; Whitman, Christine; Sankovic, Kathy; Sweeney, Denise Kosty; Geither, Carrie; Doud, Kristen; Pattakos, Gregory; Clarke, Pamela A; Argenziano, Michael; Williams, Mathew; Goldsmith, Lyn; Smith, Craig R; Naka, Yoshifumi; Stewart, Allan; Schwartz, Allan; Bell, Daniel; Van Patten, Danielle; Sreekanth, Sowmya; Smith, Peter K; Alexander, John H; Milano, Carmelo A; Glower, Donald D; Mathew, Joseph P; Harrison, J Kevin; Welsh, Stacey; Berry, Mark F; Parsa, Cyrus J; Tong, Betty C; Williams, Judson B; Ferguson, T Bruce; Kypson, Alan P; Rodriguez, Evelio; Harris, Malissa; Akers, Brenda; O'Neal, Allison; Puskas, John D; Thourani, Vinod H; Guyton, Robert; Baer, Jefferson; Baio, Kim; Neill, Alexis A; Voisine, Pierre; Senechal, Mario; Dagenais, François; O'Connor, Kim; Dussault, Gladys; Ballivian, Tatiana; Keilani, Suzanne; Speir, Alan M; Magee, Patrick; Ad, Niv; Keyte, Sally; Dang, Minh; Slaughter, Mark; Headlee, Marsha; Moody, Heather; Solankhi, Naresh; Birks, Emma; Groh, Mark A; Shell, Leslie E; Shepard, Stephanie A; Trichon, Benjamin H; Nanney, Tracy; Hampton, Lynne C; Mangusan, Ralph; Michler, Robert E; D'Alessandro, David A; DeRose, Joseph J Jr; Goldstein, Daniel J; Bello, Ricardo; Jakobleff, William; Garcia, Mario; Taub, Cynthia; Spevak, Daniel; Swayze, Roger; Sookraj, Nadia; Perrault, Louis P; Basmadjian, Arsène-Joseph; Bouchard, Denis; Carrier, Michel; Cartier, Raymond; Pellerin, Michel; Tanguay, Jean François; El-Hamamsy, Ismail; Denault, André; Demers, Philippe; Jonathan Lacharité, Sophie Robichaud; Horvath, Keith A; Corcoran, Philip C; Siegenthaler, Michael P; Murphy, Mandy; Iraola, Margaret; Greenberg, Ann; Sai-Sudhakar, Chittoor; Hasan, Ayseha; McDavid, Asia; Kinn, Bradley; Pagé, Pierre; Sirois, Carole; Latter, David; Leong-Poi, Howard; Bonneau, Daniel; Errett, Lee; Peterson, Mark D; Verma, Subodh; Feder-Elituv, Randi; Cohen, Gideon; Joyner, Campbell; Fremes, Stephen E; Moussa, Fuad; Christakis, George; Karkhanis, Reena; Yau, Terry; Farkouh, Michael; Woo, Anna; Cusimano, Robert James; David, Tirone; Feindel, Christopher; Garrard, Lisa; Fredericks, Suzanne; Mociornita, Amelia; Mullen, John C; Choy, Jonathan; Meyer, Steven; Kuurstra, Emily; Gammie, James S; Young, Cindi A; Beach, Dana; Villanueva, Robert; Acker, Michael A; Atluri, Pavan; Woo, Y Joseph; Mayer, Mary Lou; Bowdish, Michael; Starnes, Vaughn A; Shavalle, David; Matthews, Ray; Javadifar, Shadi; Romar, Linda; Kron, Irving L; Ailawadi, Gorav; Johnston, Karen; Dent, John M; Kern, John; Keim, Jessica; Burks, Sandra; Gahring, Kim; Bull, David A; Desvigne-Nickens, Patrice; Dixon, Dennis O; Haigney, Mark; Holubkov, Richard; Jacobs, Alice; Miller, Frank; Murkin, John M; Spertus, John; Wechsler, Andrew S; Sellke, Frank; McDonald, Cheryl L; Byington, Robert; Dickert, Neal; Dixon, Dennis O; Ikonomidis, John S; Williams, David O; Yancy, Clyde W; Fang, James C; Giannetti, Nadia; Richenbacher, Wayne; Rao, Vivek; Furie, Karen L; Miller, Rachel; Pinney, Sean; Roberts, William C; Walsh, Mary N; Hung, Judy; Zeng, Xin; Kilcullen, Niamh; Hung, David; Keteyian, Stephen J; Brawner, Clinton A; Aldred, Heather; Browndyke, Jeffrey; Toulgoat-Dubois, Yanne
BACKGROUND:Whether to repair nonsevere tricuspid regurgitation (TR) during surgery for ischemic mitral valve regurgitation (IMR) remains uncertain. OBJECTIVES:The goal of this study was to investigate the incidence, predictors, and clinical significance of TR progression and presence of ≥moderate TR after IMR surgery. METHODS:Patients (n = 492) with untreated nonsevere TR within 2 prospectively randomized IMR trials were included. Key outcomes were TR progression (either progression by ≥2 grades, surgery for TR, or severe TR at 2 years) and presence of ≥moderate TR at 2 years. RESULTS:Patients' mean age was 66 ± 10 years (67% male), and TR distribution was 60% ≤trace, 31% mild, and 9% moderate. Among 2-year survivors, TR progression occurred in 20 (6%) of 325 patients. Baseline tricuspid annular diameter (TAD) was not predictive of TR progression. At 2 years, 37 (11%) of 323 patients had ≥moderate TR. Baseline TR grade, indexed TAD, and surgical ablation for atrial fibrillation were independent predictors of ≥moderate TR. However, TAD alone had poor discrimination (area under the curve, ≤0.65). Presence of ≥moderate TR at 2 years was higher in patients with MR recurrence (20% vs. 9%; p = 0.02) and a permanent pacemaker/defibrillator (19% vs. 9%; p = 0.01). Clinical event rates (composite of ≥1 New York Heart Association functional class increase, heart failure hospitalization, mitral valve surgery, and stroke) were higher in patients with TR progression (55% vs. 23%; p = 0.003) and ≥moderate TR at 2 years (38% vs. 22%; p = 0.04). CONCLUSIONS:After IMR surgery, progression of unrepaired nonsevere TR is uncommon. Baseline TAD is not predictive of TR progression and is poorly discriminative of ≥moderate TR at 2 years. TR progression and presence of ≥moderate TR are associated with clinical events. (Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting [CABG] Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation, NCT00806988; Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation, NCT00807040).
PMID: 33573741
ISSN: 1558-3597
CID: 5450812

Three-Dimensional Imaging and Dynamic Modeling of Systolic Anterior Motion of the Mitral Valve

Vainrib, Alan; Massera, Daniele; Sherrid, Mark V; Swistel, Daniel G; Bamira, Daniel; Ibrahim, Homam; Staniloae, Cezar; Williams, Mathew R; Saric, Muhamed
Left ventricular outflow tract (LVOT) obstruction in hypertrophic cardiomyopathy (HCM) is often caused by systolic anterior motion (SAM) of the mitral valve caused by the interplay between increased left ventricular (LV) wall thickness and an abnormal mitral valve anatomy and geometry. Three-dimensional (3D) echocardiographic imaging of the mitral valve has revolutionized the practice of cardiology, paving the way for new methods to see and treat valvular heart disease. Here we present the novel and incremental value of 3D transesophageal echocardiography (TEE) of SAM visualization. This review first provides step-by-step instructions on acquiring and optimizing 3D TEE imaging of SAM. It then describes the unique and novel findings using standard 3D TEE rendering as well as dynamic mitral valve modeling of SAM from 3D data sets, which can provide a more detailed visualization of SAM features. The findings include double-orifice LVOT caused by the residual leaflet, the dolphin smile phenomenon, and delineation of SAM width. Finally, the review discusses the essential role of 3D TEE imaging for preprocedural assessment and intraprocedural guidance of surgical and novel percutaneous treatments of SAM.
PMID: 33059963
ISSN: 1097-6795
CID: 4641632

Consensus Document on Non-Suitability for Transcatheter Mitral Valve Repair by Edge-to-Edge Therapy

Lim, D S; Herrmann, H C; Grayburn, P; Koulogiannis, K; Ailawadi, G; Williams, M; Ng, V G; Chau, K H; Sorajja, P; Smith, R L; Guerrero, M; Daniels, D; Granada, J F; Mack, M J; Leon, M B; McCarthy, P
EMBASE:2012308194
ISSN: 2474-8706
CID: 4909532

Transcatheter Mitral Valve Edge-to-Edge Repair for Patients With Surgical Mitral Valve Repair Failure and Severe Mitral Regurgitation [Meeting Abstract]

Ibrahim, Homam; Staniloae, Cezar; Alkhalil, Ahmad; Pushkar, Illya; Sattar, Adil; Williams, Mathew
ISI:000715526900356
ISSN: 0735-1097
CID: 5074302

Computed Tomography Annular Dimensions: A Novel Method to Compare Prosthetic Valve Hemodynamics

Deeb, G Michael; Popma, Jeffrey J; Chetcuti, Stanley J; Yakubov, Steven J; Mumtaz, Mubashir; Gleason, Thomas G; Williams, Mathew R; Gada, Hemal; Oh, Jae K; Li, Shuzhen; Boulware, Michael J; Kappetein, Arie Pieter; Reardon, Michael J
BACKGROUND:Cardiac Surgical Societies Valve Labeling Task Force consensus document acknowledged inconsistent sizing and labelling of prosthetic heart valves. This study compared labeled size, internal diameter, and hemodynamics of different surgical and transcatheter valve types implanted into the same size annulus, measured by pre-procedural computed tomography (CT). METHODS:Patients were retrospectively sorted into 3 CT- annular diameter size groups: small (<23mm), medium (23-26mm), and large (>26mm). Surgical valves were sorted into 4 categories based on tissue and design: (stentless porcine, standard stented bovine, wraparound stented bovine and stented porcine). Comparisons were made within the surgical types and to a transcatheter valve. Echocardiograms were independently assessed and CTs were centrally measured. RESULTS:726 surgical and 923 transcatheter valve paired data sets were analyzed. Among the various valve types implanted into the same size CT annulus there were significant differences for size, internal diameter, and hemodynamics within all 3 size groups. Root enlargement procedures occurred in 1.2% with no differences across valve types or size groups. Transcatheter valve hemodynamics were similar to stentless valves and were significantly better than all stented valves. There was no difference in hemodynamics between the 2 bovine stented valve types and stented porcine valves were inferior to all valve types. CONCLUSIONS:This study documents prosthetic heart valve sizing and labelling inconsistencies exist. Using preoperative CT annular dimensions is the most accurate method to compare size, internal diameter, and hemodynamics of bioprosthetic aortic valves because it compares values between various valve types implanted into the same size annulus.
PMID: 32289296
ISSN: 1552-6259
CID: 4401332

TCT CONNECT-342 Outcomes of MitraClip Repair in Primary Mitral Regurgitation Patients With STS Repair Score of Less Than 6% and STS Replacement Score of Less Than 8%: Results From the Global EXPAND Study [Meeting Abstract]

Tang, G; Williams, M; Rinaldi, M; Denti, P; Kini, A; Lerakis, S; Morse, A; Rodriguez, E; Maisano, F; Kar, S
Background: Transcatheter mitral valve repair with the MitraClip system has been shown to be safe and effective for the treatment of significant primary mitral regurgitation (MR) in patients deemed prohibitive risk for surgery. This analysis evaluated the outcomes of MitraClip repair in primary MR subjects with STS PROM (Society of Thoracic Surgeons Predicted Risk of Mortality) score <6% for surgical repair and <8% for replacement from the global EXPAND (A Contemporary, Prospective Study Evaluating Real-World Experience of Performance and Safety for the Next Generation of MitraClip Devices) study.
Method(s): EXPAND is a prospective, multicenter, international, single-arm study that enrolled subjects at 57 centers in Europe and the United States. All echocardiograms were analyzed by an independent echo core laboratory, and major adverse events were adjudicated by an independent clinical events committee. Study outcomes included MR severity, procedural outcomes, major adverse events, New York Heart Association functional class and KCCQ (Kansas City Cardiomyopathy Questionnaire) score.
Result(s): Four hundred and twenty subjects with primary MR had adequate baseline echocardiographic imaging for assessment by the echo core laboratory. Of the 420 subjects, at least 166 patients either had an STS repair score <6% and an STS replacement score <8%. Average age was 77.2 +/- 10.4 years old, and 54% of the subjects were men. STS PROM score for surgical repair was 2.9 +/- 1.3% and replacement was 4.6 +/- 1.8%. Echo core laboratory-adjudicated acute procedural success, defined as survival to discharge with a successful implant resulting in reduction to MR severity <=2+, was achieved in 93.4% of the subjects. Clinical events committee-adjudicated all-cause mortality rate at 30 days was 1.2% (n = 2), and major adverse events rate was 4.2% (n = 7). MR reduction to <=2+ and MR <=1+ were achieved in 98% and 89% of subjects at 30 days, respectively. The reduction in MR severity was also associated with a significant reduction in left ventricle end-diastolic dimension (52.9 +/- 6.8 mm to 49.9 +/- 7.2 mm; n = 144; p < 0.0001) and volume (126.1 +/- 50.5 ml to 114.5 +/- 44.9 ml; n = 138; p < 0.0001). There were also improvements in functional capacity (69% New York Heart Association functional class III/IV at baseline vs. 18% at 30 days; p < 0.0001) and quality of life (mean change in KCCQ score from baseline to 30 days: +18.7 +/- 24.0; p < 0.0001). Univariate analysis of MR reduction (2 grades or more) were baseline MR severity (p < 0.0001), peak E velocity (p < 0.037), mean mitral gradient (p < 0.026), presence of ruptured chordae (p < 0.001), leaflet flail (p < 0.0002), leaflet billowing (p < 0.0001), and prolapse or flail gap (p < 0.037).
Conclusion(s): In patients with primary MR and an STS repair risk score <6% and replacement score <8%, the MitraClip NTR and XTR system was found to be safe and effective at reducing MR and improving left ventricular remodeling and was associated with significant improvements in quality of life and functional capacity. Categories: STRUCTURAL: Valvular Disease: Mitral
Copyright
EMBASE:2008355533
ISSN: 1558-3597
CID: 4659302

TCT CONNECT-468 Postoperative Atrial Fibrillation or Flutter Following Transcatheter or Surgical Aortic Valve Replacement for Severe Aortic Stenosis in Patients at Low Surgical Risk: An Analysis From the PARTNER 3 Trial [Meeting Abstract]

Shahim, B; Malaisrie, S C; George, I; Thourani, V; Russo, M; Biviano, A; Mack, M; Brown, D L; Babaliaros, V; Guyton, R; Kodali, S; Nazif, T; Genereux, P; Makkar, R; Williams, M; McCabe, J; Webb, J; Lu, M; Yu, X; Leon, M; Kosmidou, I
Background: We sought to determine the incidence and clinical impact of new-onset postoperative atrial fibrillation or flutter (POAF) in low-risk patients with severe aortic stenosis treated with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR).
Method(s): In the PARTNER 3 trial, patients with severe aortic stenosis at low surgical risk were randomized to TAVR or SAVR. POAF was defined as any atrial fibrillation occurring within the index hospitalization. Analyses were performed in the as-treated population; patients with preexistent AF were excluded. Outcomes at 2 years were analyzed according to POAF.
Result(s): Among 781 patients included in the analysis, POAF occurred in 152 (19.5%) (TAVR: 18/415 [4.3%]; SAVR: 134/366 [36.6%]). Compared with patients without POAF, those with POAF were older (74.7 vs. 73.0, p = 0.0013). At 2 years, patients with new POAF had similar unadjusted rates of the primary composite outcome of all-cause death, stroke or procedure/device or heart failure-related rehospitalization (16.6% vs. 12.0%, p = 0.10), and the individual endpoints of rehospitalization (12.1% vs. 8.7%, p = 0.19) and all-cause death (2.7% vs. 2.6%, p = 0.93). In contrast, patients with new POAF had higher rates of all bleeding (33.7% vs. 21.0%, p = 0.007) and major bleeding (14.5% vs. 8.3%, p = 0.016) and a trend toward a higher rate of stroke (4.6% vs. 2.1%, p = 0.07) at 2 years compared with patients without POAF. In adjusted analyses, POAF did not predict the primary composite outcome (hazard ratio [HR]: 1.11; 95% confidence interval [CI]: 0.64 to 1.92; p = 0.71), rehospitalization (HR: 1.24; 95% CI: 0.65 to 2.36; p = 0.51), all-cause death (HR: 0.97; 95% CI: 0.29 to 3.21; p = 0.96), stroke (HR: 1.61; 95% CI: 0.5 to 5.18; p = 0.42), or bleeding (HR: 1.15; 95% CI: 0.0.80 to 1.66; p = 0.44) at 2 years. There was no interaction between treatment modality and POAF on the primary composite outcome (p interaction = 0.51).
Conclusion(s): In the PARTNER 3 trial, in low-risk patients undergoing TAVR or SAVR, the development of POAF was more frequent following SAVR than TAVR and was not associated with increased adjusted risk for the composite outcome of death, stroke, or procedure/device or heart failure-related rehospitalization at 2 years, irrespective of treatment modality. Categories: STRUCTURAL: Valvular Disease: Aortic
Copyright
EMBASE:2008355389
ISSN: 1558-3597
CID: 4659312

TCT CONNECT-89 Impact of Pre-Existent Atrial Fibrillation on Clinical Outcomes After Transcatheter or Surgical Aortic Valve Replacement for Severe Aortic Stenosis: An Analysis From the PARTNER 3 Trial [Meeting Abstract]

Kosmidou, I; Malaisrie, S C; George, I; Thourani, V; Biviano, A; Russo, M; Brown, D L; Babaliaros, V; Guyton, R; Kodali, S; McCabe, J; Williams, M; Genereux, P; Lu, M; Yu, X; Shahim, B; Alu, M; Webb, J; Mack, M; Leon, M
Background: This study sought to determine the clinical impact of pre-existent atrial fibrillation or flutter (AF) in low-risk patients with severe aortic stenosis (AS) treated with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) in the randomized PARTNER 3 trial.
Method(s): Patients with severe AS at low surgical risk were randomized 1:1 to TAVR versus SAVR. Analyses were performed in the as-treated population. Clinical outcomes at 2 years were analyzed according to pre-existent AF.
Result(s): Among 948 patients included in the analysis, 452 (47.7%) underwent SAVR and 496 (52.3%) underwent TAVR. History of AF was present in 168 patients (17.6%) (88 of 452 [19.5%] and 80 of 496 [16.1%] treated with SAVR and TAVR, respectively). Compared with patients without AF, patients with AF were more frequently men and Caucasian, and had a more frequent history of prior pacemaker implant and higher body mass index. At 2 years, patients with AF had higher unadjusted rates of the composite outcome of death, stroke, or rehospitalization (21.2% vs. 12.9%; p = 0.007) and rehospitalization (15.3% vs. 9.4%; p = 0.03) but not all-cause death (3.8 vs. 2.6%; p = 0.45) or stroke (4.8% vs. 2.6%; p = 0.12). In adjusted analyses, patients with AF had a higher risk for the composite outcome of death, stroke, or rehospitalization (hazard ratio [HR]: 1.80; 95% confidence interval [CI]: 1.20 to 2.71; p = 0.0046) and rehospitalization (HR: 1.8; 95% CI: 0.12 to 2.90; p = 0.015), but not death (HR: 1.26; 95% CI: 0.49 to 3.20; p = 0.63) or stroke (HR: 2.11; 95% CI: 0.86 to 5.23; p = 0.10). There was no interaction between treatment modality and AF on the composite outcome (p inter = 0.83).
Conclusion(s): In the PARTNER 3 trial, low surgical risk patients with severe AS and preexistent AF had increased risk for the composite outcome of death, stroke, or rehospitalization at 2 years compared with patients without AF, irrespective of treatment with TAVR or SAVR. Categories: STRUCTURAL: Valvular Disease: Aortic
Copyright
EMBASE:2008355195
ISSN: 1558-3597
CID: 4659322