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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-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
Therapeutic blockade of inflammation in severe COVID-19 infection with intravenous n-acetylcysteine
Ibrahim, Homam; Perl, Andras; Smith, Deane; Lewis, Tyler; Kon, Zachary; Goldenberg, Ronald; Yarta, Kinan; Staniloae, Cezar; Williams, Mathew
Glucose 6-phosphate dehydrogenase (G6PD) deficiency facilitates human coronavirus infection due to glutathione depletion. G6PD deficiency may especially predispose to hemolysis upon coronavirus disease-2019 (COVID-19) infection when employing pro-oxidant therapy. However, glutathione depletion is reversible by N-acetylcysteine (NAC) administration. We describe a severe case of COVID-19 infection in a G6PD-deficient patient treated with hydroxychloroquine who benefited from intravenous (IV) NAC beyond reversal of hemolysis. NAC blocked hemolysis and elevation of liver enzymes, C-reactive protein (CRP), and ferritin and allowed removal from respirator and veno-venous extracorporeal membrane oxygenator and full recovery of the G6PD-deficient patient. NAC was also administered to 9 additional respirator-dependent COVID-19-infected patients without G6PD deficiency. NAC elicited clinical improvement and markedly reduced CRP in all patients and ferritin in 9/10 patients. NAC mechanism of action may involve the blockade of viral infection and the ensuing cytokine storm that warrant follow-up confirmatory studies in the setting controlled clinical trials.
PMCID:7374140
PMID: 32707089
ISSN: 1521-7035
CID: 4539812
The COVID-19 Pandemic and Acute Aortic Dissections in New York: A Matter of Public Health [Letter]
El-Hamamsy, Ismail; Brinster, Derek R; DeRose, Joseph J; Girardi, Leonard N; Hisamoto, Kazuhiro; Imam, Mohammed N; Itagaki, Shinobu; Kurlansky, Paul A; Lau, Christopher; Nemeth, Samantha; Williams, Mathew; Youdelman, Benjamin A; Takayama, Hiroo
PMCID:7228708
PMID: 32422182
ISSN: 1558-3597
CID: 4443832
Subclinical Leaflet Thrombosis in Transcatheter and Surgical Bioprosthetic Valves: PARTNER 3 Cardiac Computed Tomography Substudy
Makkar, Raj R; Blanke, Philipp; Leipsic, Jonathon; Thourani, Vinod; Chakravarty, Tarun; Brown, David; Trento, Alfredo; Guyton, Robert; Babaliaros, Vasilis; Williams, Mathew; Jilaihawi, Hasan; Kodali, Susheel; George, Isaac; Lu, Michael; McCabe, James M; Friedman, John; Smalling, Richard; Wong, Shing Chiu; Yazdani, Shahram; Bhatt, Deepak L; Bax, Jeroen; Kapadia, Samir; Herrmann, Howard C; Mack, Michael; Leon, Martin B
BACKGROUND:Subclinical leaflet thrombosis, characterized by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion observed on 4-dimensional computed tomography (CT), may represent a form of bioprosthetic valve dysfunction. OBJECTIVES/OBJECTIVE:The U.S. Food and Drug Administration mandated CT studies to understand the natural history of this finding, differences between transcatheter and surgical valves, and its association with valve hemodynamics and clinical outcomes. METHODS:The PARTNER 3 (The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low-Risk Patients With Aortic Stenosis) CT substudy randomized 435 patients with low-surgical-risk aortic stenosis to undergo transcatheter aortic valve replacement (n = 221) or surgery (n = 214). Serial 4-dimensional CTs were performed at 30 days and 1 year and were analyzed independently by a core laboratory. RESULTS:The incidence of HALT increased from 10% at 30 days to 24% at 1 year. Spontaneous resolution of 30-day HALT occurred in 54% of patients at 1 year, whereas new HALT appeared in 21% of patients at 1 year. HALT was more frequent in transcatheter versus surgical valves at 30 days (13% vs. 5%; p = 0.03), but not at 1 year (28% vs. 20%; p = 0.19). The presence of HALT did not significantly affect aortic valve mean gradients at 30 days or 1 year. Patients with HALT at both 30 days and 1 year, compared with those with no HALT at 30 days and 1 year, had significantly increased aortic valve gradients at 1 year (17.8 ± 2.2 mm Hg vs. 12.7. ± 0.3 mm Hg; p = 0.04). CONCLUSIONS:Subclinical leaflet thrombosis was more frequent in transcatheter compared with surgical valves at 30 days, but not at 1 year. The impact of HALT on thromboembolic complications and structural valve degeneration needs further assessment.
PMID: 32553252
ISSN: 1558-3597
CID: 4486472
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
Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: The PARTNER 3 Trial
Pibarot, Philippe; Salaun, Erwan; Dahou, Abdellaziz; Avenatti, Eleonora; Guzzetti, Ezequiel; Annabi, Mohamed-Salah; Toubal, Oumhani; Bernier, Mathieu; Beaudoin, Jonathan; Ong, Géraldine; Ternacle, Julien; Krapf, Laura; Thourani, Vinod H; Makkar, Raj; Kodali, Susheel K; Russo, Mark; Kapadia, Samir R; Malaisrie, S Chris; Cohen, David J; Leipsic, Jonathon; Blanke, Philipp; Williams, Mathew R; McCabe, James M; Brown, David L; Babaliaros, Vasilis; Goldman, Scott; Szeto, Wilson Y; Généreux, Philippe; Pershad, Ashish; Alu, Maria C; Xu, Ke; Rogers, Erin; Webb, John G; Smith, Craig R; Mack, Michael J; Leon, Martin B; Hahn, Rebecca T
Background: The objective of this study is to compare echocardiographic findings in low risk patients with severe aortic stenosis (AS) following surgical (SAVR) or transcatheter aortic valve replacement (TAVR). Methods: The Placement of Aortic Transcatheter Valves 3 (PARTNER 3) trial randomized 1000 patients with severe AS and low surgical risk to undergo either transfemoral TAVR with the balloon-expandable SAPIEN 3 valve or SAVR. Transthoracic echocardiograms obtained at baseline, and at 30 days and 1 year post-procedure were analyzed by a consortium of 2 echocardiography core laboratories. Results: The percentage of moderate/severe aortic regurgitation (AR) was low and not statistically different between TAVR vs. SAVR groups (30 days: 0.8% vs. 0.2%; p=0.38). However, mild AR was more frequent following TAVR vs. SAVR (30 days: 28.8% vs. 4.2 %; p<0.001). At 1 year, mean transvalvular gradient (13.7±5.6 vs. 11.6±5.0 mmHg; p=0.12) and aortic valve area (1.72±0.37 vs. 1.76±0.42 cm2; p=0.12) were similar in TAVR vs. SAVR. The percentage of severe prosthesis-patient mismatch (PPM) at 30 days was low and similar between TAVR and SAVR (4.6 vs. 6.3%, p=0.30). Valvulo-arterial impedance (Zva), which reflects total left ventricular hemodynamic burden, was lower with TAVR vs. SAVR at 1 year (3.7±0.8 vs. 3.9±0.9 mmHg/mL/m2 ; p<0.001). Tricuspid annulus plane systolic excursion (TAPSE) decreased and the percentage of moderate/severe tricuspid regurgitation increased from baseline to 1 year in SAVR, whereas remained unchanged in TAVR. Irrespective of treatment arm, high Zva and low TAPSE, but not moderate/severe AR or severe PPM, were associated with increased risk of the composite endpoint of mortality, stroke and re-hospitalization at 1 year. Conclusions: In patients with severe AS and low surgical risk, TAVR with the SAPIEN 3 valve was associated with similar percentage of moderate/severe AR compared with SAVR, but higher percentage of mild AR. Transprosthetic gradients, valve areas, percentage of severe PPM, and LV mass regression were similar in TAVR versus SAVR. SAVR was associated with significant deterioration of RV systolic function and greater tricuspid regurgitation, which persisted at 1 year. High Zva and low TAPSE were associated with worse outcome at 1 year whereas AR or severe PPM were not. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT02675114.
PMID: 32272848
ISSN: 1524-4539
CID: 4379032
LONG TERM MORTALITY AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATINTS WITH CHRONIC KIDNEY DISEASE NOT ON HEMODIALYSIS [Meeting Abstract]
Rzucidlo, J; Jaspan, V; Shah, B; Paone, D; Pushkar, I; Kapitman, A; Ibrahim, H; Hisamoto, K; Neuburger, P; Saric, M; Staniloae, C; Vainrib, A; Bamira, D; Jilaihawi, H; Querijero, M; Williams, M
Background Patients with chronic kidney disease (CKD) have poor short-term outcomes after transcatheter aortic valve replacement (TAVR). Methods Retrospective review identified 575 consecutive patients not on hemodialysis (HD) who underwent TAVR at a single center between September 2014 and January 2017. Patients were stratified by pre-procedural glomerular filtration rate (GFR) [>60 (n=297), 30-60 (n=242), and <30 (n=36)]. Outcomes were defined by VARC-2 criteria. Median follow-up was 811 days. Results Transfemoral artery access (TFA), used in 98.8%, and VARC-2 defined procedural success, achieved in 81.4%, did not differ between groups. However, rates of peri-procedural stroke (0.7%, 2.1%, 11.1%; p<0.001) and acute kidney injury (0%, 1.7%, 8.3%; p<0.001) were higher with lower GFR. When compared to GFR >60, risk of all-cause mortality was higher with GFR 30-60 (Hazard ratio (HR) 1.61 [1.00-2.59]) and GFR <30 (HR 2.41 [1.06-5.49]). After adjustment for differences in baseline and procedural characteristics, all-cause mortality remained higher with GFR <60 (adjusted HR 1.67 [1.03-2.70]) compared with GFR >60. Rate of long-term all-cause mortality was higher with lower GFR (10.1%, 16.5%, 19.4%). Kaplan-Meier mortality estimates are shown. Conclusion Few patients with a pre-procedural GFR <30 but not HD undergo TAVR. Despite high use of TFA and no difference in procedural success rate, long-term all-cause mortality after TAVR is higher in patients with pre-procedural CKD. [Figure presented]
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EMBASE:2005039522
ISSN: 1558-3597
CID: 4381162
DYNAMIC CHANGES IN THE MITRAL ANNULUS IMPLICATIONS FOR SCREENING FOR TRANSCATHETER MITRAL VALVE REPLACEMENT [Meeting Abstract]
Pushkar, I; Nakashima, M; Tovar, J; Kalish, C; Vainrib, A; Ibrahim, H; Hisamoto, K; Peter, N; Latson, L; Querijero, M; Saric, M; Williams, M; Jilaihawi, H
Background Computed tomography (CT) has become the standard of care for assessment for the suitability for transcatheter mitral valve replacement (TMVR); however, variation in mitral annular measurements across the cardiac cycle has thus far been poorly studied. Because of this, currently TMVR assessment is cumbersome and involves the assessment of multiple phases. We sought to further understand variation in mitral annular dimensions with the cardiac cycle and assess its potential implications for Methods A total of 118 patients presented to the heart valve clinic and underwent CT for possible TMVR assessment and were consecutively studied with multiphase CT. The mitral annulus was measured in 10 phases using 3mensio mitral planning software and several parameters collected including perimeter, area, anterior-posterior (AP) dimension and commissure-commissure (CC) dimension. Results Of the 118 patients screened, 83.9% had predominant MR, 10.2% mixed MS/MR and 5.9% predominant MS. Changes in perimeter, Area, AP and CC dimensions are shown (figure). Comparison of largest and smallest mean measurements for each phase for perimeter, Area, AP and CC dimensions showed a 2.02%, 4.36%, 8.09% and 2.86% variation respectively. Conclusion In contrast to the dynamism of the aortic annulus and neo-LVOT, the mitral annulus does not vary significantly. This may allow limitation of radiation restricting CT acquisitions to mid-systole where the neo-LVOT is smallest. [Figure presented]
Copyright
EMBASE:2005039219
ISSN: 1558-3597
CID: 4381172