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Novel Computed Tomography Classification for Bioprosthetic Aortic Valve Degeneration: Guiding Trial of Anticoagulation or Reintervention [Letter]
Nakashima, Makoto; Williams, Mathew; He, Yuxin; Du, Run; Saric, Muhamed; Staniloae, Cezar; Querijero, Michael; Pushkar, Illya; Kapitman, Anna; Jilaihawi, Hasan
PMID: 33640385
ISSN: 1876-7605
CID: 4800972
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 3Â 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 3Â 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
Long-term outcomes after transcatheter aortic valve replacement with minimal contrast in chronic kidney disease
Rzucidlo, Justyna; Jaspan, Vita; Paone, Darien; Jilaihawi, Hasan; Xia, Yuhe; Kapitman, Anna; Nakashima, Makoto; He, Yuxin; Ibrahim, Homam; Pushkar, Illya; Neuburger, Peter J; Saric, Muhamed; Bamira, Daniel; Paschke, Sonja; Kalish, Chloe; Staniloae, Cezar; Shah, Binita; Williams, Mathew
BACKGROUND:Patients with renal insufficiency have poor short-term outcomes after transcatheter aortic valve replacement (TAVR). METHODS:Retrospective chart review identified 575 consecutive patients not on hemodialysis who underwent TAVR between September 2014 and January 2017. Outcomes were defined by VARC-2 criteria. Primary outcome of all-cause mortality was evaluated at a median follow-up of 811 days (interquartile range 125-1,151). RESULTS:Preprocedural glomerular filtration rate (GFR) was ≥60 ml/min in 51.7%, 30-60 ml/min in 42.1%, and < 30 ml/min in 6.3%. Use of transfemoral access (98.8%) and achieved device success (91.0%) did not differ among groups, but less contrast was used with lower GFR (23 ml [15-33], 24 ml [14-33], 13 ml [8-20]; p < .001). Peri-procedural stroke (0.7%, 2.1%, 11.1%; p < .001) was higher with lower GFR. Core lab analysis of preprocedural computed tomography scans of patients who developed a peri-procedural stroke identified potential anatomic substrate for stroke in three out of four patients with GFR 30-60 ml/min and all three with GFR <30 ml/min (severe atheroma was the most common subtype of anatomical substrate present). Compared to GFR ≥60 ml/min, all-cause mortality was higher with GFR 30-60 ml/min (HR 1.61 [1.00-2.59]; aHR 1.61 [0.91-2.83]) and GFR <30 ml/min (HR 2.41 [1.06-5.48]; aHR 2.34 [0.90-6.09]) but not significant after multivariable adjustment. Follow-up echocardiographic data, available in 63%, demonstrated no difference in structural heart valve deterioration over time among groups. CONCLUSIONS:Patients with baseline renal insufficiency remain a challenging population with poor long-term outcomes despite procedural optimization with a transfemoral-first and an extremely low-contrast approach.
PMID: 33180381
ISSN: 1522-726x
CID: 4665422
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
Cost-effectiveness of coronary artery bypass grafting plus mitral valve repair versus coronary artery bypass grafting alone for moderate ischemic mitral regurgitation
Ferket, Bart S; Thourani, Vinod H; Voisine, Pierre; Hohmann, Samuel F; Chang, Helena L; Smith, Peter K; Michler, Robert E; Ailawadi, Gorav; Perrault, Louis P; Miller, Marissa A; O'Sullivan, Karen; Mick, Stephanie L; Bagiella, Emilia; Acker, Michael A; Moquete, Ellen; Hung, Judy W; Overbey, Jessica R; Lala, Anuradha; Iraola, Margaret; Gammie, James S; Gelijns, Annetine C; O'Gara, Patrick T; Moskowitz, Alan J; 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; 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; Chen, Yingchun; Goldfarb, Seth; Gupta, Lopa; Kirkwood, Katherine; Dobrev, Edlira; Levitan, Ron; O'Sullivan, Karen; Overbey, Jessica; Santos, Milerva; 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; 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; 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; 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; Perrault, Louis P; Basmadjian, Arsène-Joseph; Bouchard, Denis; Carrier, Michel; Cartier, Raymond; Pellerin, Michel; Tanguay, Jean François; El-Hamamsy, Ismail; Denault, André; Demers, Philippe; Robichaud, Sophie; 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; 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; Keteyian, Stephen J; Brawner, Clinton A; Aldred, Heather; Hung, Judy; Zeng, Xin; Mathew, Joseph P; Browndyke, Jeffrey; Toulgoat-Dubois, Yanne
OBJECTIVE:The Cardiothoracic Surgical Trials Network reported that left ventricular reverse remodeling at 2 years did not differ between patients with moderate ischemic mitral regurgitation randomized to coronary artery bypass grafting plus mitral valve repair (n = 150) or coronary artery bypass grafting alone (n = 151). To address health resource use implications, we compared costs and quality-adjusted survival. METHODS:We used individual patient data from the Cardiothoracic Surgical Trials Network trial on survival, hospitalizations, quality of life, and US hospitalization costs to estimate cumulative costs and quality-adjusted life years. A microsimulation model was developed to extrapolate to 10 years. Bootstrap and deterministic sensitivity analyses were performed to address uncertainty. RESULTS:In-hospital costs were $59,745 for coronary artery bypass grafting plus mitral valve repair versus $51,326 for coronary artery bypass grafting alone (difference $8419; 95% uncertainty interval, 2259-18,757). Two-year costs were $81,263 versus $67,341 (difference 13,922 [2370 to 28,888]), and quality-adjusted life years were 1.35 versus 1.30 (difference 0.05; -0.04 to 0.14), resulting in an incremental cost-effectiveness ratio of $308,343/quality-adjusted life year for coronary artery bypass grafting plus mitral valve repair. At 10 years, its costs remained higher ($107,733 vs $88,583, difference 19,150 [-3866 to 56,826]) and quality-adjusted life years showed no difference (-0.92 to 0.87), with 5.08 versus 5.08. The likelihood that coronary artery bypass grafting plus mitral valve repair would be considered cost-effective at 10 years based on a cost-effectiveness threshold of $100K/quality-adjusted life year did not exceed 37%. Only when this procedure reduces the death rate by a relative 5% will the incremental cost-effectiveness ratio fall below $100K/quality-adjusted life year. CONCLUSIONS:The addition of mitral valve repair to coronary artery bypass grafting for patients with moderate ischemic mitral regurgitation is unlikely to be cost-effective. Only if late mortality benefits can be demonstrated will it meet commonly used cost-effectiveness criteria.
PMID: 31375378
ISSN: 1097-685x
CID: 5451272
Preload functional status and stroke volume in sepsis [Meeting Abstract]
Sahatjian, J; Douglas, I; Alapat, P; Corl, K; Exline, M; Forni, L; Holder, A; Kaufman, D; Levy, M; Martin, G; Seeley, E; Self, W; Weingarten, J; Williams, M; Hansell, D
Introduction: Cardiac function is known to be negatively impacted by sepsis. Monitoring Cardiac Output (CO) and Stroke volume (SV) trends over the course of treatment may provide insight into cardiac function and may be used to predict patient outcome.
Objective(s): The goal of this study was to explore the relationship between the change in cardiac output over time in septic shock.
Method(s): FRESH is randomized controlled study, evaluating hemodynamics in critically ill patients with sepsis or septic shock (NCT02837731). Patients randomized to PLR guided resuscitation received hemodynamic monitoring for 72 or until ICU discharge, whichever occurred first (Starling SV, Cheetah Medical). Patients that exhibited an improvement in stroke volume at 12, 24, 36 and 48 hours were compared to those who did not exhibit improvement. Overall improvement in stroke volume (first SV measurement compared to last SV measurement) was also compared between groups.
Result(s): 90 patients with septic shock received hemodynamic monitoring over a 72 hour monitoring period. 60 % were female, and the average age was 61 years. Overall, 44% of assessments demonstrated a fluid responsive positive response after receiving initial resuscitation fluid of 2.3 L. Patients who exhibited improved SV at 24 and 36 hours exhibited a decreased fluid balance over the course of their ICU stay at both 24 hours (1.06 +/- 3.40 vs 3.15 +/- 4.38, p=0.029) and 36 hours (1.18 +/- 2.58 vs 3.41 +/- 4.52, p=0.032). Notably, patients who exhibited an overall improvement in SV also required less hours on vasopressors (34.50 +/- 41.03 vs 64.28 +/- 65.07, p=0.05) and decreased ICU length of stay (3.93 +/- 3 vs 5.59 +/- 5.24 days, p=0.08) (Figure 1).
Conclusion(s): We have previously shown that patients who improve SV in response to the resuscitation exhibited improved outcome. Trending cardiac output over the 72 hour monitoring period revealed additional usefulness in predicting patients with improved outcome. The results highlight the importance of trending hemodynamics in therapy
EMBASE:634009141
ISSN: 2197-425x
CID: 4784612
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
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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
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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
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EMBASE:2008355195
ISSN: 1558-3597
CID: 4659322
Bicuspid Aortic Valve Morphology and Outcomes After Transcatheter Aortic Valve Replacement
Yoon, Sung-Han; Kim, Won-Keun; Dhoble, Abhijeet; Milhorini Pio, Stephan; Babaliaros, Vasilis; Jilaihawi, Hasan; Pilgrim, Thomas; De Backer, Ole; Bleiziffer, Sabine; Vincent, Flavien; Schmidit, Tobias; Butter, Christian; Kamioka, Norihiko; Eschenbach, Lena; Renker, Matthias; Asami, Masahiko; Lazkani, Mohamad; Fujita, Buntaro; Birs, Antoinette; Barbanti, Marco; Pershad, Ashish; Landes, Uri; Oldemeyer, Brad; Kitamura, Mitusnobu; Oakley, Luke; Ochiai, Tomoki; Chakravarty, Tarun; Nakamura, Mamoo; Ruile, Philip; Deuschl, Florian; Berman, Daniel; Modine, Thomas; Ensminger, Stephan; Kornowski, Ran; Lange, Rudiger; McCabe, James M; Williams, Mathew R; Whisenant, Brian; Delgado, Victoria; Windecker, Stephan; Van Belle, Eric; Sondergaard, Lars; Chevalier, Bernard; Mack, Michael; Bax, Jeroen J; Leon, Martin B; Makkar, Raj R
BACKGROUND:Bicuspid aortic stenosis accounts for almost 50% of patients undergoing surgical aortic valve replacement in the younger patients. Expanding the indication of transcatheter aortic valve replacement (TAVR) toward lower-risk and younger populations will lead to increased use of TAVR for patients with bicuspid aortic valve (BAV) stenosis despite the exclusion of bicuspid anatomy in all pivotal clinical trials. OBJECTIVES/OBJECTIVE:This study sought to evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices. METHODS:Patients with BAV confirmed by central core laboratory computed tomography (CT) analysis were included from the international multicenter BAV TAVR registry. BAV morphology including the number of raphe, calcification grade in raphe, and leaflet calcium volume were assessed with CT analysis in a masked fashion. Primary outcomes were all-cause mortality at 1 and 2 years, and secondary outcomes included 30-day major endpoints and procedural complications. RESULTS:A total of 1,034 CT-confirmed BAV patients with a mean age of 74.7 years and Society of Thoracic Surgeons score of 3.7% underwent TAVR with contemporary devices (n = 740 with Sapien 3; n = 188 with Evolut R/Pro; n = 106 with others). All-cause 30-day, 1-year, and 2-year mortality was 2.0%, 6.7%, and 12.5%, respectively. Multivariable analysis identified calcified raphe and excess leaflet calcification (defined as more than median calcium volume) as independent predictors of 2-year all-cause mortality. Both calcified raphe plus excess leaflet calcification were found in 269 patients (26.0%), and they had significantly higher 2-year all-cause mortality than those with 1 or none of these morphological features (25.7% vs. 9.5% vs. 5.9%; log-rank p < 0.001). Patients with both morphological features had higher rates of aortic root injury (p < 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016). CONCLUSIONS:Outcomes of TAVR in bicuspid aortic stenosis depend on valve morphology. Calcified raphe and excess leaflet calcification were associated with increased risk of procedural complications and midterm mortality. (Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry; NCT03836521).
PMID: 32854836
ISSN: 1558-3597
CID: 4581542