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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-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
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
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