227 results on '"Sabik, Jf"'
Search Results
2. Outcomes After Coronary Stenting or Bypass Surgery for Men and Women With Unprotected Left Main Disease: The EXCEL Trial
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Serruys, PWJC, Cavalcante e Silva, Rafael, Collet, C, Kappetein, Arie-Pieter, Sabik, JF, Banning, AP, Taggart, DP, Sabate, M, Pomar, J, Boonstra, P W, Lembo, NJ, Onuma, Y, Simonton, CA, Morice, MC, McAndrew, T, Dressler, O, Stone, GW, Graduate School, ACS - Heart failure & arrhythmias, Cardiology, and Cardiothoracic Surgery
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surgical procedures, operative ,cardiovascular diseases - Abstract
Objectives: The aim of the present study was to assess outcomes after coronary artery bypass grafting surgery (CABG) and percutaneous coronary intervention (PCI) according to sex in a large randomized trial of patients with unprotected left main disease. Background: In the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial, sex had a significant interaction effect with revascularization strategy, and women had an overall higher mortality when treated with PCI than CABG. Methods: The EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial was a multinational randomized trial that compared PCI with everolimus-eluting stents and CABG in patients with unprotected left main disease. The primary endpoint was the composite of all-cause death, myocardial infarction, or stroke at 3 years. Results: Of 1,905 patients randomized, 1,464 (76.9%) were men and 441 (23.1%) were women. Compared with men, women were older; had higher prevalence rates of hypertension, hyperlipidemia, and diabetes; and were less commonly smokers but had lower coronary anatomic burden and complexity (mean SYNTAX score 24.2 vs. 27.2, p < 0.001). By multivariate analysis, sex was not independently associated with either the primary endpoint (hazard ratio [HR]: 1.10; 95% confidence interval [CI]: 0.82 to 1.48; p = 0.53) or all-cause death (HR: 1.39; 95% CI: 0.92 to 2.10; p = 0.12) at 3 years. At 30 days, all-cause death, myocardial infarction, or stroke had occurred in 8.9% of woman treated with PCI, 6.2% of women treated with CABG, 3.6% of men treated with PCI, and 8.4% of men treated with CABG (p for interaction = 0.003). The 3-year rate of the composite primary endpoint was 19.7% in women treated with PCI, 14.6% in women treated with CABG, 13.8% in men treated with PCI, and 14.7% in men treated with CABG (p for interaction = 0.06). These differences were driven by higher periprocedural rates of myocardial infarction in women after PCI and in men after CABG. Conclusions: In patients with unprotected left main disease in the EXCEL trial, sex was not an independent predictor of adverse outcomes after revascularization. However, women undergoing PCI had a trend toward worse outcomes, a finding related to associated comorbidities and increased periprocedural complications. Further studies are required to determine the optimal revascularization modality in women with complex coronary artery disease.
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- 2018
3. Left Main Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Prior Cerebrovascular Disease Results From the EXCEL Trial
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Diamond, J, Madhavan, MV, Sabik, JF, Serruys, PWJC, Kappetein, Arie-Pieter, Leon, MB, Taggart, DP, Berland, J, Morice, MC, Gersh, BJ, Kandzari, DE, Dressler, O, Stone, GW, and Cardiothoracic Surgery
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- 2018
4. Outcomes After Left Main Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting According to Lesion Site Results From the EXCEL Trial
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Gershlick, A H, Kandzari, DE, Banning, A, Taggart, DP, Morice, MC, Lembo, NJ, Brown, W M, Banning, AP, Merkely, B, Horkay, F, van Boven, AJ, Boonstra, P W, Dressler, O, Sabik, JF, Serruys, PWJC, Kappetein, Arie-Pieter, Stone, GW, and Cardiothoracic Surgery
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- 2018
5. Everolimus-eluting stents or bypass surgery for left main coronary artery disease
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Stone, Gw, Sabik, Jf, Serruys, Pw, Simonton, Ca, Généreux, P, Puskas, J, Kandzari, De, Morice, Mc, Lembo, N, Brown WM 3rd, Taggart, Dp, Banning, A, Merkely, B, Horkay, F, Boonstra, Pw, van Boven AJ, Ungi, I, Bogáts, G, Mansour, S, Noiseux, N, Sabaté, M, Pomar, J, Hickey, M, Gershlick, A, Buszman, P, Bochenek, A, Schampaert, E, Pagé, P, Dressler, O, Kosmidou, I, Mehran, R, Pocock, Sj, Kappetein, Ap, van Es GA, Leon, Mb, Gersh, B, Chaturvedi, S, Kint, Pp, Valgimigli, M, Colombo, A, Costa, M, Di Mario, C, Ellis, S, Fajadet, J, Fearon, W, Kereiakes, D, Makkar, R, Mintz, Gs, Moses, Jw, Teirstein, P, Ruel, M, Sergeant, P, Mack, M, Fontana, G, Mohr, Fw, Nataf, P, Smith, C, Boden, B, Fox, K, Maron, D, Steg, G, Blackstone, E, Juni, P, Parise, H, Wallentin, L, Bertrand, M, Krucoff, M, Turina, M, Ståhle, E, Tijssen, J, Brill, D, Atkins, C, Applegate, B, Argenziano, M, Faly, Rc, Dauerman, H, Davidson, C, Griffith, B, Reisman, M, Rizik, D, Sakwa, M, Shemin, R, Romano, M, Hamm, C, Gummert, J, Tamburino, C, Alfieri, O, Savina, C, de Bruyne, B, Machado, Fp, Uva, S, Moccetti, T, Siclari, F, Hildick Smith, D, Szekely, L, Erglis, A, Stradins, P, Abizaid, A, Bento Sousa LC, Belardi, J, Navia, D, Park, Sj, Lee, Jw, Meredith, I, Smith, J, Yehuda, Ob, Schneijdenberg, R, Ronden, J, Jonk, J, Jonkman, A, van Remortel, E, de Zwart, I, Elshout, L, de Vries, T, Andreae, R, Tol van, J, Teurlings, E, Balachandran, S, Breazna, A, Jenkins, P, Mcandrew, T, Marx, So, Connolly, Mw, Hong, Mk, Weinberger, J, Wong, Sc, Dizon, J, Biviano, A, Morrow, J, Wang, D, Corral, M, Alfonso, M, Sanchez, R, Wright, D, Djurkovic, C, Lustre, M, Jankovic, I, Sanidas, E, Lasalle, L, Maehara, A, Matsumura, M, Sun, E, Iacono, S, Greenberg, T, Jacobson, J, Pullano, A, Gacki, M, Liu, S, Cohen, Dj, Magnuson, E, Baron, Sj, Wang, K, Traylor, K, Worthley, S, Stuklis, R, Barbato, E, Stockman, B, Dubois, C, Meuris, B, Vrolix, M, Dion, R, Bento de Souza LC, Costantini, C, Woitowicz, V, Hueb, W, Stolf, N, Beydoun, H, Baskett, R, Curtis, M, Kieser, T, Doucet, S, Pellerin, M, Hamburger, J, Cook, R, Kutryk, M, Peterson, M, Madan, M, Fremes, S, Mehta, S, Cybulsky, I, Prabhakar, M, Peniston, C, Welsh, R, Macarthur, R, Berland, J, Bessou, Jp, Carrié, D, Glock, Y, Darremont, O, Deville, C, Grimaud, Jp, Soula, P, Lefèvre, T, Maupas, E, Durrleman, N, Silvestri, M, Houel, R, Pratt, A, Francis, J, Van Belle, E, Vicentelli, A, Luchner, A, Hilker, M, Endemann, Dh, Felix, S, Wollert, Hg, Walther, T, Erbel, R, Jacob, H, Kahlert, P, Kupatt, C, Näbauer, M, Schmitz, C, Scholtz, W, Börgermann, J, Schuler, G, Borger, M, Davierwala, P, Fontos, G, Székely, L, Bedogni, F, Panisi, P, Berti, S, Glauber, M, Marzocchi, A, Di Bartolomeo, R, Merlo, M, Guagliumi, G, Fenili, F, Napodano, M, Gerosa, G, Ribichini, F, Faggian, Giuseppe, Saccà, S, Giacomin, A, Mignosa, C, Tumscitz, C, Savini, C, Van Mieghem, N, von Birgelen, C, Grandjean, J, Kubica, J, Anisimowicz, L, Zmudka, K, Sadowski, J, Hernández García, J, Such, M, Macaya, C, Rodríguez Hernández JE, Maroto, L, Serra, A, Padro, J, Tenas, Ms, De Souza, A, Egred, M, Clark, S, Trivedi, U, Jain, A, Uppal, R, Redwood, S, Young, C, Stables, Rh, Pullan, M, Uren, N, Pessotto, R, Abu Fadel, M, Peyton, M, Allaqaband, S, O’Hair, D, Bachinsky, W, Mumtaz, M, Blankenship, J, Casale, A, Brott, B, Davies, J, Brown, D, Cannon, L, Talbott, J, Chang, G, Macheers, S, Choi, J, Henry, C, Cutlip, D, Khabbaz, K, Das, G, Liao, K, Diver, D, Thayer, J, Dobies, D, Fliegner, K, Fischbein, M, Feldman, T, Pearson, P, Foster, M, Briggs, R, Giugliano, G, Engelman, D, Gordon, P, Ehsan, A, Grantham, J, Allen, K, Grodin, J, Jessen, M, Gruberg, L, Taylor JR Jr, Gupta, S, Hermiller J., Jr, Heimansohn, D, Iwaoka, R, Chan, B, Kander, Nh, Duff, S, Brown, W, Karmpaliotis, D, Kini, A, Filsoufi, F, Kong, D, Lin, S, Kutcher, M, Kincaid, E, Leya, F, Bakhos, M, Liberman, H, Halkos, M, Lips, D, Eales, F, Mahoney, P, Rich, J, Barreiro, C, Cheng, W, Metzger, C, Greenfield, T, Moses, J, Palacios, I, Macgillivray, T, Perin, E, Del Prete, J, Pompili, V, Kilic, A, Ragosta, M, Kron, I, Rashid, J, Mueller, D, Riley, R, Reimers, C, Patel, N, Resar, J, Shah, A, Schneider, J, Landvater, L, Reardon, M, Shavelle, D, Baker, C, Singh, J, Maniar, H, Wei, L, Strain, J, Zapolanski, A, Taheri, H, Ad, N, Tannenbaum, M, Prabhakar, G, Waksman, R, Corso, P, Wang, J, Fiocco, M, Wilson, Bh, Steigel, Rm, Chadwick, S, Zidar, F, Oswalt, J., Stone, Gregg W., Sabik, Joseph F., Serruys, Patrick W., Simonton, Charles A., Généreux, Philippe, Puskas, John, Kandzari, David E., Morice, Marie Claude, Lembo, Nichola, Brown, W. Morri, Taggart, David P., Banning, Adrian, Merkely, Béla, Horkay, Ferenc, Boonstra, Piet W., Van Boven, Ad J., Ungi, Imre, Bogáts, Gabor, Mansour, Samer, Noiseux, Nicola, Sabaté, Manel, Pomar, José, Hickey, Mark, Gershlick, Anthony, Buszman, Pawel, Bochenek, Andrzej, Schampaert, Erick, Pagé, Pierre, Dressler, Ovidiu, Kosmidou, Ioanna, Mehran, Roxana, Pocock, Stuart J., Kappetein, A. Pieter, for the EXCEL Trial Investigators:, [. . ., Antonio, Marzocchi, DI BARTOLOMEO, Roberto, ], . ., and Cardiothoracic Surgery
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Male ,medicine.medical_specialty ,medicine.medical_treatment ,Coronary Artery Disease ,Kaplan-Meier Estimate ,030204 cardiovascular system & hematology ,law.invention ,Coronary artery disease ,03 medical and health sciences ,0302 clinical medicine ,Percutaneous Coronary Intervention ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Clinical endpoint ,Drug-Eluting Stent ,Humans ,Everolimus ,030212 general & internal medicine ,cardiovascular diseases ,Coronary Artery Bypass ,Aged ,Female ,Middle Aged ,Drug-Eluting Stents ,business.industry ,Coronary Artery Bypa ,Medicine (all) ,Percutaneous coronary intervention ,General Medicine ,medicine.disease ,Surgery ,Cardiac surgery ,Everolimu ,surgical procedures, operative ,Bypass surgery ,Conventional PCI ,Cardiology ,business ,medicine.drug ,Human - Abstract
BACKGROUND: Patients with obstructive left main coronary artery disease are usually treated with coronary-artery bypass grafting (CABG). Randomized trials have suggested that drug-eluting stents may be an acceptable alternative to CABG in selected patients with left main coronary disease. METHODS: We randomly assigned 1905 eligible patients with left main coronary artery disease of low or intermediate anatomical complexity to undergo either percutaneous coronary intervention (PCI) with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). Anatomic complexity was assessed at the sites and defined by a Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score of 32 or lower (the SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature, with 0 as the lowest score and higher scores [no upper limit] indicating more complex coronary anatomy). The primary end point was the rate of a composite of death from any cause, stroke, or myocardial infarction at 3 years, and the trial was powered for noninferiority testing of the primary end point (noninferiority margin, 4.2 percentage points). Major secondary end points included the rate of a composite of death from any cause, stroke, or myocardial infarction at 30 days and the rate of a composite of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses. RESULTS: At 3 years, a primary end-point event had occurred in 15.4% of the patients in the PCI group and in 14.7% of the patients in the CABG group (difference, 0.7 percentage points; upper 97.5% confidence limit, 4.0 percentage points; P=0.02 for noninferiority; hazard ratio, 1.00; 95% confidence interval, 0.79 to 1.26; P=0.98 for superiority). The secondary end-point event of death, stroke, or myocardial infarction at 30 days occurred in 4.9% of the patients in the PCI group and in 7.9% in the CABG group (P
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- 2017
6. Quality-of-Life After Everolimus-Eluting Stents or Bypass Surgery for Left-Main Disease Results From the EXCEL Trial
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Baron, SJ, Chinnakondepalli, K, Magnuson, EA, Kandzari, DE, Puskas, JD, Ben-Yehuda, O, Es, Gerrit-anne, Taggart, DP, Morice, MC, Lembo, NJ, Brown, W M, Banning, A, Simonton, CA, Kappetein, Arie-Pieter, Sabik, JF, Serruys, PWJC (Patrick), Stone, GW, Cohen, DJ, Cardiology, and Cardiothoracic Surgery
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- 2017
7. Coronary-Artery Bypass Grafting
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Blackstone Eh, Raza S, and Sabik Jf rd
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medicine.medical_specialty ,Cardiopulmonary Bypass ,Bypass grafting ,business.industry ,Treatment outcome ,MEDLINE ,General Medicine ,Arteries ,030204 cardiovascular system & hematology ,Article ,law.invention ,Surgery ,03 medical and health sciences ,0302 clinical medicine ,medicine.anatomical_structure ,Text mining ,Treatment Outcome ,law ,Cardiopulmonary bypass ,medicine ,Humans ,030212 general & internal medicine ,Coronary Artery Bypass ,business ,Artery - Published
- 2016
8. Functional ischemic mitral regurgitation: myocardial viability as a predictor of postoperative outcome after isolated coronary artery bypass grafting.
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Mihaljevic T, Gillinov AM, and Sabik JF 3rd
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- 2009
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9. Coronary artery bypass graft patency and competitive flow.
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Sabik JF 3rd, Blackstone EH, Sabik, Joseph F 3rd, and Blackstone, Eugene H
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- 2008
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10. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.
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Fihn SD, Gardin JM, Abrams J, Berra K, Blankenship JC, Dallas AP, Douglas PS, Foody JM, Gerber TC, Hinderliter AL, King SB 3rd, Kligfield PD, Krumholz HM, Kwong RY, Lim MJ, Linderbaum JA, Mack MJ, Munger MA, Prager RL, and Sabik JF
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- 2012
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11. Does location of the second internal thoracic artery graft influence outcome of coronary artery bypass grafting?
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Sabik JF III, Stockins A, Nowicki ER, Blackstone EH, Houghtaling PL, Lytle BW, and Loop FD
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- 2008
12. A benchmark for evaluating innovative treatment of left main coronary disease.
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Sabik JF III, Blackstone EH, Firstenberg M, and Lytle BW
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- 2007
13. Occurrence and risk factors for reintervention after coronary artery bypass grafting.
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Sabik JF 3rd, Blackstone EH, Gillinov AM, Smedira NG, and Lytle BW
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- 2006
14. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines Developed in Collaboration With the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and Society of Thoracic Surgeons.
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Hillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, Cigarroa JE, Disesa VJ, Hiratzka LF, Hutter AM Jr, Jessen ME, Keeley EC, Lahey SJ, Lange RA, London MJ, Mack MJ, Patel MR, Puskas JD, Sabik JF, and Selnes O
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- 2011
15. Do postoperative hemodynamic parameters add prognostic value for mortality after surgical aortic valve replacement?
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Velders BJJ, Vriesendorp MD, Asch FM, Dagenais F, Lange R, Reardon MJ, Rao V, Sabik JF 3rd, Groenwold RHH, and Klautz RJM
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Background: Although various hemodynamic parameters to assess prosthetic performance are available, prosthesis-patient mismatch (PPM) is defined exclusively by effective orifice area (EOA) index thresholds. Adjusting for the Society of Thoracic Surgeons predicted risk of mortality (STS PROM), we aimed to explore the added value of postoperative hemodynamic parameters for the prediction of all-cause mortality at 5 years after aortic valve replacement., Methods: Data were obtained from the Pericardial Surgical Aortic Valve Replacement (PERIGON) Pivotal Trial, a multicenter prospective cohort study examining the performance of the Avalus bioprosthesis. Candidate predictors were assessed at the first follow-up visit; patients who had no echocardiography data, withdrew consent, or died before this visit were excluded. Candidate predictors included peak jet velocity, mean pressure gradient, EOA, predicted and measured EOA index, Doppler velocity index, indexed internal prosthesis orifice area, and categories for PPM. The performance of Cox models was investigated using the c-statistic and net reclassification improvement (NRI), among other tools., Results: A total of 1118 patients received the study valve, of whom 1022 were eligible for the present analysis. In univariable analysis, STS PROM was the sole significant predictor of all-cause mortality (hazard ratio, 1.40; 95% confidence interval, 1.26-1.55). When extending the STS PROM with single hemodynamic parameters, neither the c-statistics nor the NRIs demonstrated added prognostic value compared to a model with STS PROM alone. Similar findings were observed when multiple hemodynamic parameters were added., Conclusions: The STS PROM was found to be the main predictor of patient prognosis. The additional prognostic value of postoperative hemodynamic parameters for the prediction of all-cause mortality was limited., Competing Interests: Dr Velders reported institutional research grant and speaker fees paid to his department by 10.13039/100004374Medtronic. Dr Vriesendorp reported institutional research support and reimbursement of travel expenses from 10.13039/100004374Medtronic. Dr Asch reported institutional grants or research contracts from Medtronic, Abbott, Edwards Lifesciences, Boston Scientific, 10.13039/501100005035Biotronik, Corcym, and HLT Medical. Dr Dagenais reported serving as a lecturer, consultant, and proctor for Cook Medical; a proctor and lecturer for Medtronic; and a lecturer for Edwards Lifesciences. Dr Lange reported serving as a consultant for Medtronic, being a stockholder in and receiving royalties from Medtronic, and consulting for HighLife Medical. Dr Reardon reported consulting for Medtronic, Abbott Medical, Boston Scientific, Gore Medical, and Transverse Medical, with fees paid to his department. Dr Rao reported consulting for Medtronic, Gore, and Abbott and serving on an advisory board for Medtronic. Dr Sabik was the North American Principal Investigator for the PERIGON Pivotal Trial, Medtronic. Dr Groenwold reported no conflicts of interest. Dr Klautz was European Principal Investigator of the PERIGON Pivotal Trial and reported research support and consultation fees from 10.13039/100004374Medtronic. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest., (© 2023 The Author(s).)
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- 2023
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16. Outcomes of Surgical Bioprosthetic Aortic Valve Replacement in Patients Aged ≤65 and >65 Years.
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Kiaii BB, Moront MG, Patel HJ, Ruel M, Bensari FN, Kress DC, Liu F, Klautz RJM, and Sabik JF 3rd
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- Aged, Female, Humans, Male, Middle Aged, Aortic Valve diagnostic imaging, Aortic Valve surgery, Hemodynamics, Prosthesis Design, Treatment Outcome, Aortic Valve Stenosis, Bioprosthesis, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation adverse effects
- Abstract
Background: Implantation of a bioprosthetic valve is a reasonable choice for patients aged > 65 years. For middle-aged patients there is less certainty about whether a mechanical or bioprosthetic valve is best., Methods: The Pericardial Surgical Aortic Valve Replacement (PERIGON) Pivotal Trial is evaluating the safety and efficacy of the Avalus bioprosthesis (Medtronic). We evaluated clinical and echocardiographic outcomes through 5 years of follow-up, stratified by age ≤ 65 and >65 years., Results: Two hundred seventy-one patients (24.2%) were ≤65 years old and 847 (75.8%) >65 years old. Most patients in both groups were men (217 [80.1%] vs 623 [73.6%], respectively; P = .031). Younger patients had a lower Society of Thoracic Surgeons risk of mortality (1.1% ± 0.9% vs 2.2% ± 1.4%, P < .001), better baseline New York Heart Association class (P = .004), and fewer comorbidities than older patients. At 5 years mortality was lower among younger than older patients (5.3% vs 14.0%, P < .001) and no cases of structural valve deterioration occurred in either group. Effective orifice area was similar between age groups (P = .11), and mean gradient was 13.9 ± 5.4 vs 12.0 ± 4.1 mm Hg (P < .001). Multivariable linear regression identified several parameters associated with mean aortic gradient at 5 years, including baseline age and mean aortic gradient, discharge stroke volume index and EOA, and implanted valve size. Ninety-five percent of patients were in New York Heart Association class I/II through 5 years in both age groups (P = .85)., Conclusions: Findings from this analysis demonstrate satisfactory safety, hemodynamic performance, and durability of the Avalus bioprosthesis through a 5-year follow-up in patients aged ≤ 65 and >65 years., (Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)
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- 2023
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17. A mysterious case of chest pain, dyspnea, and palpitations in a healthy young female: Citalopram or robotic minithoracotomy?
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Golzarian H, Turnow M, Elston S, Kannan P, Chakraborty S, Widmer MB, Mughal S, Kohan S, Nguyen M, Sabik JF, and Patel SM
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- 2023
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18. Impact of Periprocedural Adverse Events After PCI and CABG on 5-Year Mortality: The EXCEL Trial.
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Jain SS, Li D, Dressler O, Kotinkaduwa L, Serruys PW, Kappetein AP, Sabik JF, Morice MC, Puskas J, Kandzari DE, Karmpaliotis D, Lembo NJ, Brown WM 3rd, Banning AP, and Stone GW
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- Humans, Treatment Outcome, Coronary Artery Bypass, Comorbidity, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease surgery, Percutaneous Coronary Intervention
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Background: The relative risks for different periprocedural major adverse events (MAE) after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) on subsequent mortality have not been described., Objectives: The aim of this study was to assess the association between periprocedural MAE occurring within 30 days postprocedure and early and late mortality after left main coronary artery revascularization by PCI and CABG., Methods: In the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, patients with left main disease were randomized to PCI vs CABG. The associations between 12 prespecified nonfatal MAE and subsequent 5-year all-cause and cardiovascular death in 1,858 patients were examined using logistic regression., Results: One or more nonfatal MAE occurred in 111 of 935 patients (11.9%) after PCI and 419 of 923 patients (45.4%) after CABG (P < 0.0001). Patients with MAE were older and had more baseline comorbidities. Within 5 years, all-cause death occurred in 117 and 87 patients after PCI and CABG, respectively. Experiencing an MAE was a strong independent predictor of 5-year mortality after both PCI (adjusted OR: 4.61; 95% CI: 2.71-7.82) and CABG (adjusted OR: 3.25; 95% CI: 1.95-5.41). These associations were present within the first 30 days and between 30 days and 5 years postprocedure. Major or minor bleeding with blood transfusion ≥2 U was an independent predictor of 5-year mortality after both procedures. Stroke, unplanned revascularization for ischemia, and renal failure were significantly associated with mortality only after CABG., Conclusions: In the EXCEL trial, nonfatal periprocedural MAE were strongly associated with early and late mortality after both PCI and CABG for left main disease., Competing Interests: Funding Support and Author Disclosures The EXCEL trial was funded by Abbott Vascular. Dr Serruys has received consulting fees from Sinomed, Philips/Volcano, Xeltis, SMT, Novartix, and Meril Life. Dr A. Pieter Kappetein is an employee of Medtronic. Dr Sabik has received consulting fees from Medtronic; and is an advisory board member for Medtronic Cardiac Surgery. Dr Morice is a shareholder and chief executive officer of the European Cardiovascular Research Center; and is a minor shareholder of Electroducer. Dr Puskas has received consulting fees from Medtronic; and receives royalties for surgical instruments he designed that are marketed by Scanlan International. Dr Kandzari has received institutional research and grant support from Abbott Vascular, Biotronik, Boston Scientific, Cardiovascular Systems, Medtronic, and Teleflex; and has received consulting honoraria from Cardiovascular Systems and Medtronic. Dr Karmpaliotis has received honoraria from Abiomed, Abbott Vascular, and Boston Scientific; and holds equity in Saranas, Soundbite, and Traverse Vascular. Dr Lembo is an advisory board member for Abbott Vascular; and is on the Speakers Bureaus of Abbott Vascular, Boston Scientific, Medtronic, and Abiomed. Dr Banning has received honoraria from Abbott Vascular and Boston Scientific; and has received an institutional educational grant from Boston Scientific. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, and Infraredx; has served as a consultant to Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, Gore, and Amgen; and has equity or options from Ancora, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter. Dr Stone’s daughter is an employee of Medtronic. Dr Stone’s employer, Mount Sinai Hospital, receives research support from Abbott, Abiomed, Bioventrix, Cardiovascular Systems, Phillips, Biosense Webster, Shockwave, Vascular Dynamics, and V-Wave. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2023
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19. Endoscopic vs Open Vein Harvest in Drug-Eluting Stents or Bypass Surgery for Left Main Disease Trial.
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Jarrett CM, Pelletier M, Abu-Omar Y, Baeza C, Elgudin Y, Markowitz A, Vega PR, Dressler O, Kappetein AP, Serruys PW, Stone GW, and Sabik JF 3rd
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- Humans, Constriction, Pathologic, Saphenous Vein transplantation, Endoscopy, Treatment Outcome, Coronary Artery Disease surgery, Drug-Eluting Stents, Myocardial Infarction, Stroke
- Abstract
Background: We investigated outcomes of coronary artery bypass grafting (CABG) with endoscopic vein harvest (EVH) vs open vein harvest (OVH) within the Evaluation of XIENCE Versus CABG (EXCEL) trial., Methods: All patients in EXCEL randomized to CABG were included in this study. For this analysis, the primary end points were ischemia-driven revascularization (IDR) and graft stenosis or occlusion at 5 years. Additional end points were as follows: a composite of death from any cause, stroke, or myocardial infarction; bleeding; blood product transfusion; major arrhythmia; and infection requiring antibiotics. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses., Results: Of the 957 patients randomized to CABG, 686 (71.7%) received at least 1 venous graft with 257 (37.5%) patients in the EVH group and 429 (62.5%) patients in the OVH group. At 5 years, IDR was higher (11.5% vs 6.7%; P = .047) in the EVH group. At 5 years, rates of graft stenosis or occlusion (9.7% vs 5.4%; P = .054) and the primary end point (17.4% vs 20.9%; P = .27) were similar. In-hospital bleeding (11.3% vs 13.8%; P = .35), in-hospital blood product transfusion (12.8% vs 13.1%; P = .94), and infection requiring antibiotics within 1 month (13.6% vs 16.8%; P = .27) were similar between EVH and OVH patients. Major arrhythmia in the hospital (19.8% vs 13.5%; P = .03) and within 1 month (21.8% vs 15.4%; P = .03) was higher in EVH patients., Conclusions: IDR at 5 years was higher in the EVH group. EVH and OVH patients had similar rates of graft stenosis or occlusion and the composite of death, stroke, or myocardial infarction at 5 years., (Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)
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- 2023
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20. Pledgeted versus nonpledgeted sutures in aortic valve replacement: Insights from a prospective multicenter trial.
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Velders BJJ, Vriesendorp MD, Sabik JF 3rd, Dagenais F, Labrousse L, Bapat V, Aldea GS, Anyanwu AC, Cai Y, and Klautz RJM
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Objective: The objective of this study was to compare short- and midterm clinical and echocardiographic outcomes according to the use of pledgeted sutures during aortic valve replacement., Methods: Patients with aortic stenosis or regurgitation requiring aortic valve replacement were enrolled in a prospective cohort study to evaluate the safety of a new stented bioprosthesis. Outcomes were analyzed according to the use of pledgets (pledgeted group) or no pledgets (nonpledgeted group). The primary outcome was a composite of thromboembolism, endocarditis, and major paravalvular leak at 5 years of follow-up. Secondary outcomes included multiple clinical endpoints and hemodynamic outcomes. Propensity score matching was performed to adjust for prognostic factors, and subanalyses with small valve sizes (<23 mm) and suturing techniques were performed., Results: The pledgeted group comprised 640 patients (59%), and the nonpledgeted group 442 (41%), with baseline discrepancies in demographic characteristics, comorbidities, and stenosis severity. There were no differences between groups in any outcome. After propensity score matching, the primary outcome occurred in 41 (11.7%) patients in the pledgeted and 36 (9.8%) in the nonpledgeted group ( P = .51). The effective orifice area was smaller in the pledgeted group ( P = .045), whereas no difference was observed for the mean or peak pressure gradient. Separate subanalyses with small valve sizes and suturing techniques did not show relevant differences., Conclusions: In this large propensity score-matched cohort, comprehensive clinical outcomes were comparable between patients who underwent aortic valve replacement with pledgeted and nonpledgeted sutures up to 5 years of follow-up, but pledgets might lead to a slightly smaller effective orifice area in the long run., (© 2022 The Author(s).)
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- 2022
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21. Association of Volume and Outcomes in 234 556 Patients Undergoing Surgical Aortic Valve Replacement.
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Thourani VH, Brennan JM, Edelman JJ, Thibault D, Jawitz OK, Bavaria JE, Higgins RSD, Sabik JF 3rd, Prager RL, Dearani JA, MacGillivray TE, Badhwar V, Svensson LG, Reardon MJ, Shahian DM, Jacobs JP, Ailawadi G, Szeto WY, Desai N, Roselli EE, Woo YJ, Vemulapalli S, Carroll JD, Yadav P, Malaisrie SC, Russo M, Nguyen TC, Kaneko T, Tang G, Ruel M, Chikwe J, Lee R, Habib RH, George I, Leon MB, and Mack MJ
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- Aortic Valve surgery, Humans, Risk Factors, Treatment Outcome, Aortic Valve Stenosis, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation methods, Transcatheter Aortic Valve Replacement adverse effects
- Abstract
Background: The relationship between institutional volume and operative mortality after surgical aortic valve replacement (SAVR) remains unclear., Methods: From January 2013 to June 2018, 234 556 patients underwent isolated SAVR (n = 144 177) or SAVR with coronary artery bypass grafting (CABG) (n = 90 379) within the Society of Thoracic Surgeons Adult Cardiac Surgery Database. The association between annualized SAVR volume (group 1 [1-25 SAVRs], group 2 [26-50 SAVRs], group 3 [51-100 SAVRs], and group 4 [>100 SAVRs]) and operative mortality and composite major morbidity or mortality was assessed. Random effects models were used to evaluate whether historical (2013-2015) SAVR volume or risk-adjusted outcomes explained future (2016-2018) risk-adjusted outcomes., Results: The annualized median number of SAVRs per site was 35 (interquartile range, 22-59; isolated aortic valve replacement [AVR], 20; AVR with CABG, 13). Among isolated SAVR cases, the mean operative mortality and composite morbidity or mortality were 1.5% and 9.7%, respectively, at the highest-volume sites (group 4), with significantly higher rates among progressively lower-volume groups (P trend < .001). After adjustment, lower-volume centers had increased odds of operative mortality (group 1 vs group 4 [reference]: adjusted odds ratio [AOR] for SAVR, 2.24 [95% CI, 1.91-2.64]; AOR for SAVR with CABG, 1.96 [95% CI, 1.67-2.30]) and major morbidity or mortality (AOR for SAVR, 1.53 [95% CI, 1.39-1.69]; AOR for SAVR with CABG, 1.46 [95% CI, 1.32-1.61]) compared with the highest-volume institutions. Substantial variation in outcomes was observed across hospitals within each volume category, and prior outcomes explained a greater proportion of hospital operative outcomes than did prior volume., Conclusions: Operative outcomes after SAVR with or without CABG is inversely associated with institutional procedure volumes; however, prior outcomes are more predictive of future outcomes than is prior volume. Given the excellent outcomes observed at many lower-volume hospitals, procedural outcomes may be preferable to procedural volumes as a quality metric., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)
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- 2022
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22. Why the categorization of indexed effective orifice area is not justified for the classification of prosthesis-patient mismatch.
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Vriesendorp MD, Deeb GM, Reardon MJ, Kiaii B, Bapat V, Labrousse L, Rao V, Sabik JF 3rd, Gearhart E, and Klautz RJM
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- Aortic Valve diagnostic imaging, Aortic Valve surgery, Bioprosthesis, Clinical Trials as Topic, Humans, Obesity complications, Risk Factors, Treatment Outcome, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation methods
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Objectives: Although the impact of prosthesis-patient mismatch (PPM) on survival has been widely studied, there has been little debate about whether the current definition of PPM truly reflects hemodynamic obstruction. This study aimed to validate the categorization of indexed effective orifice area (EOAi) for the classification of PPM., Methods: In total, 2171 patients who underwent aortic valve replacement with a surgical stented bioprosthesis in 5 trials (CoreValve US High-Risk, SURTAVI [Surgical Replacement and Transcatheter Aortic Valve Implantation Trial], Evolut Low Risk, PERIGON [PERIcardial SurGical AOrtic Valve ReplacemeNt] Pivotal Trial for the Avalus valve, and PERIGON Japan) were used for this analysis. The echocardiographic images at the 1-year follow-up visit were evaluated to explore the association between EOAi and mean aortic gradient and its interaction with other patient characteristics, including obesity. In addition, different criteria of PPM were compared with reflect elevated mean aortic gradients (≥20 mm Hg)., Results: A relatively smaller exponential decay in mean aortic gradient was found for increasing EOAi, as the slope on the log scale was -0.83 versus -2.5 in the publication from which the current cut-offs for PPM originate. The accuracy of the American Society of Echocardiography, Valve Academic Research Consortium-2, and European Association of Cardiovascular Imaging definitions of PPM to reflect elevated mean aortic gradients was 49%, 57%, and 57%, respectively. The relation between EOAi and mean aortic gradient was not significantly different between obese and non-obese patients (P = .20)., Conclusions: The use of EOAi thresholds to classify patients with PPM is undermined by a less-pronounced exponential relationship between EOAi and mean aortic gradient than previously demonstrated. Moreover, recent adjustment for obesity in the definition of PPM is not supported by these data., (Copyright © 2020 The Author(s). Published by Elsevier Inc. All rights reserved.)
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- 2022
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23. Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes.
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Klautz RJM, Dagenais F, Reardon MJ, Lange R, Moront MG, Labrousse L, Weissman NJ, Rao V, Patel HJ, Liu F, and Sabik JF
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- Aged, Animals, Aortic Valve surgery, Cattle, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prosthesis Design, Treatment Outcome, Aortic Valve Insufficiency surgery, Aortic Valve Stenosis surgery, Bioprosthesis adverse effects, Endocarditis surgery, Heart Valve Prosthesis adverse effects, Heart Valve Prosthesis Implantation adverse effects, Thromboembolism etiology
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Objectives: This analysis evaluated the safety, durability and haemodynamic performance of a stented bovine pericardial valve through 5 years of follow-up in patients with an indication for surgical aortic valve replacement., Methods: Kaplan-Meier analysis was used to estimate the incidence of survival and valve-related thromboembolism, major paravalvular leak, endocarditis, structural valve deterioration (SVD) and reintervention. The mean aortic gradient and New York Heart Association (NYHA) functional class were also evaluated., Results: A total of 1118 patients have received the Avalus valve; 564 have completed the 5-year follow-up. The median follow-up was 4.85 years (4810 patient-years total follow-up). At baseline, the mean age was 70.2 ± 9.0 years; 75.1% of patients were male. The Society of Thoracic Surgeons predicted risk of mortality was 2.0 ± 1.4%. Most patients were in NYHA functional class II (46.8%) or III (40.3%). At the 5-year follow-up, the overall Kaplan-Meier survival rate was 88.1% (85.9-90.0%). The Kaplan-Meier event rates were 5.6% (4.3-7.2%) for thromboembolism, 4.4% (3.2-6.0%) for endocarditis, 0.2% (0.0-0.7%) for a major paravalvular leak and 3.2% (2.3-4.6%) for reintervention. There were no cases of SVD. The mean gradient decreased from 42.1 ± 17.1 mmHg at baseline, to 13.1 ± 4.7 mmHg at discharge and remained stable at 12.5 ± 4.6 mmHg at 5 years. More than 95% of patients were in NYHA functional class I/II 5 years after surgery., Conclusions: The findings of a high survival rate, excellent safety, no SVD and stable haemodynamic performance and functional status through 5 years of follow-up are encouraging. Additional follow-up is needed to assess the long-term durability of this contemporary surgical bioprosthesis., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)
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- 2022
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24. Outcomes of great vessel debranching to facilitate thoracic endovascular aortic repair.
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Patel AJ, Ambani RN, Sarode AL, King AH, Baeza CR, Elgudin Y, Colvard BD, Kumins NH, Kashyap VS, Sabik JF, and Cho JS
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- Aged, Aorta, Thoracic diagnostic imaging, Aorta, Thoracic surgery, Blood Vessel Prosthesis, Humans, Male, Middle Aged, Retrospective Studies, Stents, Treatment Outcome, Ulcer surgery, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic surgery, Blood Vessel Prosthesis Implantation, Endovascular Procedures
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Objective: With the expanding application of endovascular technology, the need to deploy into zone 0 has been encountered on occasion. In the present study, we evaluated the outcomes of great vessel debranching (GVD) as a method of extending the proximal landing zone to facilitate thoracic endovascular aortic repair (TEVAR)., Methods: We performed a single-center retrospective review of all patients who had undergone GVD followed by TEVAR between May 2013 and December 2020. The primary outcome was primary patency of all targeted vessels, with all-cause perioperative mortality as a secondary outcome. Kaplan-Meier analysis was used to account for censoring of mortality and primary patency. The extent of hybrid aortic repairs was characterized into type I (GVD plus TEVAR without ascending aorta or aortic arch reconstruction, type II (GVD plus TEVAR with ascending aorta reconstruction), and type III (GVD plus TEVAR with ascending aorta and aortic arch reconstruction with an elephant trunk (soft [surgical] or frozen [endovascular]])., Results: A total of 42 patients (23 men [54.8%]; mean age, 62.2 ± 11.2 years) had undergone GVD, with 122 vessels revascularized (42 innominate, 42 left common carotid, and 38 left subclavian arteries). The indication for TEVAR was aneurysmal degeneration from aortic dissection in 32 patients (76.2%), a thoracic aneurysm in 9 patients (21.4%), and a perforated aortic ulcer in 1 patient (2.4%). The median duration between GVD and TEVAR was 82 days. The mean follow-up period was 25.7 ± 23.5 months. Type I repair was performed in 4, type II in 16, and type III in 22 patients. The perioperative mortality, stroke, and paraplegia rates were 9.5%, 7.1%, and 2.4%, respectively. Neither the extent of repair (P = .80) nor a history of aortic repair (P = .90) was associated with early mortality. Of the 38 patients who had survived the perioperative period, 6 had died >30 days postoperatively. At 36 months, the survival estimate was 68.6% (95% confidence interval, 45.7%-83.4%). The overall primary patency of the innominate artery, left common carotid artery, and left subclavian artery was 100%, 89.5%, and 94.1%, respectively. The primary-assisted patency rate was 100% for all the vessels., Conclusions: We found GVD to be a safe and effective method of extending the proximal landing zone into zone 0 with outstanding primary patency rates. Further studies are required to confirm the safety and longer term durability for these patients., (Copyright © 2022 Society for Vascular Surgery. All rights reserved.)
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- 2022
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25. Cost-Effectiveness of Percutaneous Coronary Intervention Versus Bypass Surgery for Patients With Left Main Disease: Results From the EXCEL Trial.
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Magnuson EA, Chinnakondepalli K, Vilain K, Serruys PW, Sabik JF, Kappetein AP, Stone GW, and Cohen DJ
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- Aged, Cost-Benefit Analysis, Humans, Medicare, Randomized Controlled Trials as Topic, Treatment Outcome, United States, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease surgery, Drug-Eluting Stents, Percutaneous Coronary Intervention methods
- Abstract
Background: The EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) demonstrated in patients with left main coronary artery disease, no significant difference between coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) with everolimus-eluting stents for the composite end point of death, stroke, or myocardial infarction at 5 years. However, all-cause mortality at 5 years was higher with PCI. Long-term cost-effectiveness of these 2 strategies has heretofore not been evaluated., Methods: From 2010 to 2014, 1905 patients with left main coronary artery disease were randomized to CABG (n=957) or PCI (n=948). Costs ($2019) were assessed over 5 years using resource-based costing and Medicare reimbursement rates. Health utilities were assessed using the EuroQOL 5-dimension questionnaire. Five-year EXCEL data in combination with US lifetables were used to develop a Markov model to evaluate lifetime cost-effectiveness. An incremental cost-effectiveness ratio <$50 000 per quality-adjusted life year (QALY) gained was considered highly cost-effective., Results: Index revascularization procedure costs were $4,850/patient higher with CABG, and total costs for the index hospitalization were $17 610/patient higher with CABG ($32 297 versus $19 687, P <0.001). Cumulative 5-year costs were $20 449/patient higher with CABG. CABG was projected to increase lifetime costs by $21 551 while increasing quality-adjusted life expectancy by 0.49 QALYs, yielding an incremental cost-effectiveness ratio of $44 235/QALY. In a post hoc sensitivity analysis using mortality hazard ratios from a meta-analysis of all randomized CABG versus PCI in left main disease trials, the gain associated with CABG was 0.08 to 0.14 QALYs, resulting in an incremental cost-effectiveness ratio of $139 775 to $232 710/QALY gained., Conclusions: Based on data from the EXCEL trial, CABG is an economically attractive revascularization strategy compared with PCI over a lifetime horizon for patients with significant left main coronary artery disease. However, this conclusion is sensitive to the long-term mortality rates with the 2 strategies, and CABG is no longer highly cost-effective when substituting the pooled treatment effect from the 4 major PCI versus CABG trials for left main disease., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT01205776.
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- 2022
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26. Reply: The forced correlation between ISCHEMIA and the inaccurate CABG recommendations of the 2021 American College of Cardiology/American Heart Association/Society for cardiovascular Angiography coronary revascularization guidelines.
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Bakaeen FG, Ruel M, Girardi LN, and Sabik JF 3rd
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- 2022
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27. The American Association for Thoracic Surgery and The Society of Thoracic Surgeons reasoning for not endorsing the 2021 ACC/AHA/SCAI Coronary Revascularization Guidelines.
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Sabik JF 3rd, Bakaeen FG, Ruel M, Moon MR, Malaisrie SC, Calhoon JH, Girardi LN, and Guyton R
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- American Heart Association, Humans, Myocardial Ischemia surgery, Societies, Medical, United States, Myocardial Revascularization standards, Practice Guidelines as Topic
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- 2022
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28. Outcomes of Vascular Closure Device Use After Transfemoral Coronary Intervention: Insights From the EXCEL Trial.
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Kuno T, Claessen BE, Guedeney P, Serruys PW, Sabik JF 3rd, Simonton CA, Kandzari DE, Morice MC, Zhang Z, Dressler O, Mehran R, Ben-Yehuda O, Kappetein AP, and Stone GW
- Subjects
- Femoral Artery surgery, Hemorrhage epidemiology, Hemorrhage etiology, Hemorrhage prevention & control, Humans, Treatment Outcome, Coronary Artery Disease diagnosis, Coronary Artery Disease surgery, Percutaneous Coronary Intervention adverse effects, Vascular Closure Devices
- Abstract
Objectives: To assess the safety and efficacy of using vascular closure devices (VCDs) in percutaneous coronary intervention (PCI) for left main coronary artery disease (LM-CAD)., Background: VCDs provide rapid hemostasis for patients undergoing PCI with transfemoral access (TFA); however, the safety and efficacy of VCDs continues to be debated., Methods: We analyzed data from the EXCEL trial in patients with LM-CAD in whom PCI was performed via TFA with vs without VCD. The primary endpoint was a composite of death, myocardial infarction (MI), or stroke. Bleeding Academic Research Consortium (BARC) type 2-5 bleeding at 30 days was also assessed. Propensity-score matching analysis was used., Results: Among 694 patients with LM-CAD undergoing TFA-PCI, 423 (61.0%) received VCDs (collagen plug, 320 [75.7%]; suture mediated, 55 [13.0%]; others, 48 [11.3%]). Patients with and without VCD use had similar 30-day rates of BARC type 2-5 bleeding (5.0% vs 6.7%, respectively; P=.30) and BARC type 3-5 bleeding (2.1% vs 3.7%, respectively; P=.20). There were no significant differences in the rates of death, MI, or stroke in patients with and without VCD use at 30 days (4.7% vs 4.1%, respectively; P=.74) or at 5 years (20.3% vs 24.2%, respectively; P=.16). These results were similar after adjustment., Conclusion: In the EXCEL trial, LM-CAD PCI via TFA using VCD was associated with similar 30-day rates of bleeding and comparable early and late major adverse cardiovascular events compared with manual compression.
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- 2021
29. Implications of Biomarker Discordance After Coronary Artery Revascularization: The EXCEL Trial.
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Redfors B, Gregson J, Ben-Yehuda O, Serruys PW, Kappetein AP, Sabik JF 3rd, Pocock SJ, and Stone GW
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- Biomarkers blood, Cause of Death trends, Coronary Artery Disease blood, Coronary Artery Disease mortality, Humans, Postoperative Period, Survival Rate trends, United States epidemiology, Coronary Artery Disease surgery, Coronary Vessels surgery, Creatine Kinase, MB Form blood, Myocardial Revascularization, Randomized Controlled Trials as Topic, Troponin blood
- Published
- 2021
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30. Fifty-Seventh Annual Meeting, The Society of Thoracic Surgeons.
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Sabik JF 3rd
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- Humans, Congresses as Topic, Societies, Medical, Surgeons, Thoracic Surgery
- Published
- 2021
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31. Antithrombotic therapy and bleeding events after aortic valve replacement with a novel bioprosthesis.
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Klautz RJM, Vriesendorp MD, Dagenais F, Labrousse L, Bapat V, Moront MG, Misfeld M, Gearhart E, Kappetein AP, and Sabik JF 3rd
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Objective: Several recent-generation surgical tissue valves have been found to have bleeding rates exceeding rates recommended by regulatory bodies. We explored bleeding events using data from the Pericardial Surgical Aortic Valve Replacement (PERIGON) Pivotal Trial for the Avalus valve (Medtronic, Minneapolis, Minn) to examine whether this end point remains relevant for the evaluation of bioprostheses., Methods: Patients (n = 1115) underwent aortic valve replacement. Bleeding and thromboembolic event episodes in patients within 3 years postimplant were analyzed for frequency, timing, and severity, focusing on patients taking antiplatelet/anticoagulant medications at the time of the event. Clinical and hemodynamic outcomes are also reported., Results: At 3 years, the Kaplan-Meier cumulative probability estimate of all-cause death was 7.2% (cardiac, 3.6%; valve-related, 1.1%). The Kaplan-Meier cumulative probability estimates of all and major hemorrhage were 8.7% and 5.2%, respectively. Ninety-nine bleeding events occurred in 86 patients: most occurred >30 days postsurgery. Among the 51 late major bleeds, in 5 cases the patients were taking anticoagulant/antiplatelet medication for prophylaxis after surgical aortic valve replacement at the time of the event, whereas the remaining patients were taking medications for other reasons. Age (hazard ratio, 1.035; 95% confidence interval, 1.004-1.068), peripheral vascular disease (hazard ratio, 2.135; 95% confidence interval, 1.106-4.122), renal dysfunction (hazard ratio, 1.920; 95% confidence interval, 1.055-3.494), and antithrombotic medication use at the time of the event (hazard ratio, 1.417; 95% confidence interval, 1.048-1.915) were associated with late bleeds (major and minor)., Conclusions: Overall clinical outcomes demonstrated low mortality and few complications except for major bleeding. Most bleeding events occurred >30 days after surgery and in patients taking antiplatelet and/or anticoagulation for indications other than postimplant prophylaxis., (Copyright © 2019. Published by Elsevier Inc.)
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- 2021
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32. Sizing Strategy and Implant Considerations for the Avalus Valve.
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Moront MG, Sabik JF 3rd, Reardon MJ, Dagenais F, Lange R, Walther T, Kerendi F, and Klautz RJM
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- Aortic Valve, Humans, Prosthesis Design, Prosthesis Fitting, Aortic Valve Disease surgery, Bioprosthesis, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation methods
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Hemodynamic performance of the Avalus valve through 3 years after implant is comparable to that of contemporary surgical bioprostheses. Many variables affect hemodynamic outcomes, including surgical technique. This article describes our experience with the Avalus bioprosthesis and strategies to achieve optimal hemodynamic performance., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)
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- 2020
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33. Effect of red blood cell storage duration on major postoperative complications in cardiac surgery: A randomized trial.
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Koch CG, Sessler DI, Duncan AE, Mascha EJ, Li L, Yang D, Figueroa P, Sabik JF 3rd, Mihaljevic T, Svensson LG, and Blackstone EH
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- Aged, Female, Follow-Up Studies, Hospital Mortality trends, Humans, Incidence, Length of Stay, Male, Postoperative Complications epidemiology, Retrospective Studies, Single-Blind Method, Survival Rate trends, United States epidemiology, Blood Preservation methods, Cardiac Surgical Procedures methods, Erythrocyte Transfusion methods, Erythrocytes, Postoperative Complications prevention & control
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Background: Although observational studies suggest an association between transfusion of older red blood cell (RBC) units and increased postoperative risk, randomized trials have not supported this. The objective of this randomized trial was to test the effect of RBC storage age on outcomes after cardiac surgery., Methods: From July 2007 to May 2016, 3835 adults undergoing coronary artery bypass grafting, cardiac valve procedures, or ascending aorta repair, either alone or in combination, were randomized to transfusion of RBCs stored for ≤14 days (younger units) or for ≥20 days (older units) intraoperatively and throughout the postoperative hospitalization. According to protocol, 2448 patients were excluded because they did not receive RBC transfusions. Among the remaining 1387 modified intent-to-treat patients, 701 were randomized to receive younger RBC units (median age, 11 days) and the remaining 686 to receive older units (median age, 25 days). The primary endpoint was composite morbidity and mortality, analyzed using a generalized estimating equation (GEE) model. The trial was discontinued midway owing to enrollment constraints., Results: A total of 5470 RBC units were transfused, including 2783 in the younger RBC storage group and 2687 in the older RBC storage group. The GEE average relative-effect odds ratio was 0.77 (95% confidence interval [CI], 0.50-1.19; P = .083) for the composite morbidity and mortality endpoint. In-hospital mortality was lower for the younger RBC storage group (2.1% [n = 15] vs 3.4% [n = 23]), as was occurrence of other adverse events except for atrial fibrillation, although all CIs crossed 1.0., Conclusions: This clinical trial, which was stopped at its midpoint owing to enrollment constraints, supports neither the efficacy nor the futility of transfusing either younger or older RBC units. The effects of transfusing RBCs after even more prolonged storage (35-42 days) remains untested., (Copyright © 2019 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2020
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34. Aortic Valve Replacement in Bioprosthetic Failure: Insights From The Society of Thoracic Surgeons National Database.
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Kalra A, Raza S, Hussain M, Shorbaji K, Delozier S, Deo SV, Khera S, Kleiman NS, Reardon MJ, Kolte D, Gupta T, Mustafa R, Bhatt DL, and Sabik JF 3rd
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- Aged, Aged, 80 and over, Databases, Factual, Female, Heart Valve Prosthesis adverse effects, Humans, Male, Middle Aged, Postoperative Complications etiology, Retrospective Studies, Stroke etiology, Aortic Valve surgery, Bioprosthesis adverse effects, Heart Valve Prosthesis Implantation adverse effects, Prosthesis Failure
- Abstract
Background: This study was conducted to determine the current nationwide trends and outcomes of reoperative surgical aortic valve replacement (SAVR) performed for a degenerated bioprosthesis., Methods: Data from The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database were used. All patients who underwent isolated reoperative SAVR for a degenerated aortic bioprosthesis between January 2012 and December 2016 were included. Patients who had other concomitant cardiac surgery procedures or active endocarditis were excluded. Changes during this period were tracked with trend analyses., Results: The number of patients undergoing SAVR for bioprosthetic failure increased substantially between 2012 and 2014 (782 in 2012 to 844 in 2013 and to 900 in 2014; relative change, +7.25%); this trend reversed significantly between 2015 and 2016 (decreased to 873 in 2015 and to 840 in 2016; relative change, -3.4%; P = .005). Patients were older in 2012-2014 (65.80 ± 13.52 years) compared with 2015-2016 (64.45 ± 12.91 years; P = .001). Mean STS-predicted mortality risk score decreased from 4.55% in 2012-2014 to 4.25% in 2015-2016 (P = .001). There was no difference in postoperative stroke (1.80% vs 1.80%, P = .87), renal failure requiring dialysis (2.7% vs 2.8%, P = .69), or operative mortality (3.5% vs 4.0%, P = .36) after reoperative SAVR in 2012-2014 and 2015-2016, respectively., Conclusions: The number of patients undergoing SAVR for a degenerated bioprosthesis is decreasing in the United States, particularly among older and high-risk patients. These trends may reflect the adoption of valve-in-valve transcatheter aortic valve replacement for a degenerated bioprosthesis after its United States Food and Drug Administration approval in 2015., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)
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- 2020
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35. Implications of Alternative Definitions of Peri-Procedural Myocardial Infarction After Coronary Revascularization.
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Gregson J, Stone GW, Ben-Yehuda O, Redfors B, Kandzari DE, Morice MC, Leon MB, Kosmidou I, Lembo NJ, Brown WM 3rd, Karmpaliotis D, Banning AP, Pomar J, Sabaté M, Simonton CA, Dressler O, Kappetein AP, Sabik JF 3rd, Serruys PW, and Pocock SJ
- Subjects
- Coronary Artery Bypass adverse effects, Coronary Artery Bypass mortality, Coronary Artery Disease mortality, Coronary Artery Disease surgery, Female, Follow-Up Studies, Humans, Male, Mortality trends, Myocardial Infarction etiology, Myocardial Infarction mortality, Myocardial Revascularization adverse effects, Myocardial Revascularization trends, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention mortality, Postoperative Complications etiology, Postoperative Complications mortality, Treatment Outcome, Coronary Artery Bypass trends, Coronary Artery Disease diagnostic imaging, Myocardial Infarction diagnostic imaging, Percutaneous Coronary Intervention trends, Postoperative Complications diagnostic imaging
- Abstract
Background: Varying definitions of procedural myocardial infarction (PMI) are in widespread use., Objectives: This study sought to determine the rates and clinical relevance of PMI using different definitions in patients with left main coronary artery disease randomized to percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) surgery in the EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial., Methods: The pre-specified protocol definition of PMI (PMI
Prot ) required a large elevation of creatine kinase-MB (CK-MB), with identical threshold for both procedures. The Third Universal Definition of MI (types 4a and 5) (PMIUD ) required lesser biomarker elevations but with supporting evidence of myocardial ischemia, different after PCI and CABG. For the PMIUD , troponins were used preferentially (available in 49.5% of patients), CK-MB otherwise. The multivariable relationship between each PMI type and 5-year mortality was determined., Results: PMIProt occurred in 34 of 935 (3.6%) patients after PCI and 56 of 923 (6.1%) patients after CABG (difference -2.4%; 95% confidence interval [CI]: -4.4% to -0.5%; p = 0.015). The corresponding rates of PMIUD were 37 (4.0%) and 20 (2.2%), respectively (difference 1.8%; 95% CI: 0.2% to 3.4%; p = 0.025). Both PMIProt and PMIUD were associated with 5-year cardiovascular mortality (adjusted hazard ratio [HR]: 2.18 [95% CI: 1.13 to 4.23] and 2.87 [95% CI: 1.44 to 5.73], respectively). PMIProt was associated with a consistent hazard of cardiovascular mortality after both PCI and CABG (pinteraction = 0.86). Conversely, PMIUD was strongly associated with cardiovascular mortality after CABG (adjusted HR: 11.94; 95% CI: 4.84 to 29.47) but not after PCI (adjusted HR: 1.14; 95% CI: 0.35 to 3.67) (pinteraction = 0.004). Results were similar for all-cause mortality and with varying PMIUD biomarker definitions. Only large biomarker elevations (CK-MB ≥10× upper reference limit and troponin ≥70× upper reference limit) were associated with mortality., Conclusions: The rates of PMI after PCI and CABG vary greatly with different definitions. In the EXCEL trial, the pre-specified PMIProt was associated with similar hazard after PCI and CABG, whereas PMIUD was strongly associated with mortality after CABG but not after PCI. (EXCEL Clinical Trial [EXCEL]; NCT01205776)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2020
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36. The fallacy of indexed effective orifice area charts to predict prosthesis-patient mismatch after prosthesis implantation.
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Vriesendorp MD, De Lind Van Wijngaarden RAF, Head SJ, Kappetein AP, Hickey GL, Rao V, Weissman NJ, Reardon MJ, Moront MG, Sabik JF, and Klautz RJM
- Subjects
- Aortic Valve diagnostic imaging, Aortic Valve surgery, Humans, Prosthesis Design, Prosthesis Fitting, Treatment Outcome, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation adverse effects
- Abstract
Aims: Indexed effective orifice area (EOAi) charts are used to determine the likelihood of prosthesis-patient mismatch (PPM) after aortic valve replacement (AVR). The aim of this study is to validate whether these EOAi charts, based on echocardiographic normal reference values, can accurately predict PPM., Methods and Results: In the PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Pivotal Trial, 986 patients with aortic valve stenosis/regurgitation underwent AVR with an Avalus valve. Patients were randomly split (50:50) into training and test sets. The mean measured EOAs for each valve size from the training set were used to create an Avalus EOAi chart. This chart was subsequently used to predict PPM in the test set and measures of diagnostic accuracy (sensitivity, specificity, and negative and positive predictive value) were assessed. PPM was defined by an EOAi ≤0.85 cm2/m2, and severe PPM was defined as EOAi ≤0.65 cm2/m2. The reference values obtained from the training set ranged from 1.27 cm2 for size 19 mm up to 1.81 cm2 for size 27 mm. The test set had an incidence of 66% of PPM and 24% of severe PPM. The EOAi chart inaccurately predicted PPM in 30% of patients and severe PPM in 22% of patients. For the prediction of PPM, the sensitivity was 87% and the specificity 37%. For the prediction of severe PPM, the sensitivity was 13% and the specificity 98%., Conclusion: The use of echocardiographic normal reference values for EOAi charts to predict PPM is unreliable due to the large proportion of misclassifications., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2020
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37. Coronary Artery Bypass Grafting in Cancer Patients: Prevalence and Outcomes in the United States.
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Guha A, Dey AK, Kalra A, Gumina R, Lustberg M, Lavie CJ, Sabik JF 3rd, and Addison D
- Subjects
- Aged, Cardiovascular Diseases surgery, Case-Control Studies, Coronary Artery Bypass adverse effects, Coronary Artery Bypass economics, Female, Hospital Costs, Humans, Length of Stay, Outcome Assessment, Health Care statistics & numerical data, Postoperative Hemorrhage epidemiology, Prevalence, Registries, Retrospective Studies, United States epidemiology, Cardiovascular Diseases epidemiology, Coronary Artery Bypass statistics & numerical data, Hospital Mortality, Neoplasms epidemiology
- Abstract
Objective: To characterize the contemporary efficacy and utilization patterns of coronary artery bypass grafting (CABG) in specific cancer types., Methods: We leveraged the data from the National Inpatient Sample and plotted trends of utilization and outcomes of isolated CABG (with no other additional surgeries during the same hospitalization) procedures from January 1, 2003, through September 1, 2015. Propensity score matching was used to assess for potential differences in outcomes by type of cancer status among contemporary (2012-2015) patients., Results: Overall, the utilization of CABG decreased over time (250,677 in 2003 vs 134,534 in 2015, P<.001). However, the proportion of those with comorbid cancer increased (7.0% vs 12.6%, P<.001). Over time, in-hospital mortality associated with CABG use in cancer remained unchanged (.9% vs 1.0%, P=.72); yet, cancer patients saw an increase in associated major bleeding (4.5% vs 15.3%, P<.001) and rate of stroke (.9% vs 1.5%, P<.001) over time. In-hospital cost-of-care associated with CABG-use in cancer also increased over time ($29,963 vs $33,636, P<.001). When stratified by cancer types, in-hospital mortality was not higher in breast, lung, prostate, colon cancer, or lymphoma versus non-cancer CABG patients (all P>.05). However, there was a significantly higher prevalence of major bleeding but not stroke in patients with breast and prostate cancer only compared with non-cancer CABG patients (P<.01). Discharge dispositions were not found to be different between cancer sub-groups and non-cancer patients (P>.05), except for breast cancer patients who had lower home care, but higher skilled care disposition (P<.001)., Conclusion: Among those undergoing CABG, the prevalence of comorbid cancer has steadily increased. Outside of major bleeding, these patients appear to share similar outcomes to those without cancer indicating that CABG utilization should be not be declined in cancer patients when otherwise indicated. Further research into the factors underlying the decision to pursue CABG in specific cancer sub-groups is needed., (Copyright © 2020 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)
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- 2020
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38. Considerations for an optimal definition of procedural myocardial infarction.
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Stone GW, Ben-Yehuda O, Sabik JF, Kappetein AP, and Serruys PW
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- Coronary Artery Bypass, Humans, Coronary Artery Disease, Myocardial Infarction diagnosis, Percutaneous Coronary Intervention
- Published
- 2020
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39. Impact of left ventricular ejection fraction on clinical outcomes after left main coronary artery revascularization: results from the randomized EXCEL trial.
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Thuijs DJFM, Milojevic M, Stone GW, Puskas JD, Serruys PW, Sabik JF 3rd, Dressler O, Crowley A, Head SJ, and Kappetein AP
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- Coronary Vessels, Humans, Stroke Volume, Treatment Outcome, Ventricular Function, Left, Coronary Artery Disease epidemiology, Coronary Artery Disease surgery, Heart Failure, Percutaneous Coronary Intervention
- Abstract
Aim: To evaluate the impact of left ventricular ejection fraction (LVEF) on 3-year outcomes in patients with left main coronary artery disease (LMCAD) undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in the EXCEL trial., Methods and Results: The EXCEL trial randomized patients with LMCAD to PCI with everolimus-eluting stents (n = 948) or CABG (n = 957). Among 1804 patients with known baseline LVEF, 74 (4.1%) had LVEF <40% [heart failure with reduced ejection fraction (HFrEF)], 152 (8.4%) LVEF 40-49% [heart failure with mid-range ejection fraction (HFmrEF)] and 1578 (87.5%) LVEF ≥50% (heart failure with preserved ejection fraction). Patients with HFrEF vs. HFmrEF vs. preserved LVEF experienced a longer postoperative hospital stay (9.0 vs. 7.0 vs. 6.0 days, P = 0.02) with greater peri-procedural complications after CABG, while hospital stay after PCI was unaffected by LVEF (1.5 vs. 2.0 vs. 1.0 days, P = 0.20). The composite primary endpoint of death, stroke, or myocardial infarction at 3 years was 29.3% (PCI) vs. 27.6% (CABG) in patients with HFrEF, 16.2% vs. 15.0% in patients with HFmrEF, and 14.5% vs. 14.6% in those with preserved LVEF, respectively (P
interaction = 0.90). Smoothing spline analysis demonstrated that the 3-year risk of all-cause death increased when LVEF decreased, both in patients undergoing CABG and PCI., Conclusion: In the EXCEL trial, the composite rate of death, stroke or myocardial infarction at 3 years was significantly higher in patients with HFrEF compared with HFmrEF or preserved LVEF, driven by an increased rate of all-cause death. No significant differences after PCI vs. CABG were observed among patients with HFrEF, HFmrEF and preserved LVEF. Longer-term follow-up could provide important insights on differences in clinical outcomes that might emerge over time., Clinical Trial Registration: ClinicalTrials.gov Identifier NCT01205776., (© 2020 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)- Published
- 2020
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40. Impact of non-respect of SYNTAX score II recommendation for surgery in patients with left main coronary artery disease treated by percutaneous coronary intervention: an EXCEL substudy.
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Modolo R, Chichareon P, van Klaveren D, Dressler O, Zhang Y, Sabik JF, Onuma Y, Kappetein AP, Stone GW, and Serruys PW
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- Cohort Studies, Coronary Artery Bypass, Humans, Prospective Studies, Treatment Outcome, Coronary Artery Disease surgery, Percutaneous Coronary Intervention
- Abstract
Objectives: The SYNTAX score II (SSII) was developed from the SYNTAX trial to predict the 4-year all-cause mortality after left main or multivessel disease revascularization and to facilitate the decision-making process. The SSII provides the following treatment recommendations: (i) coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) (equipoise risk), (ii) CABG preferred (excessive risk for PCI) or (iii) PCI preferred (excessive risk for CABG). We sought to externally validate SSII and to investigate the impact of not abiding by the SSII recommendations in the randomized EXCEL trial of PCI versus CABG for left main disease., Methods: The calibration plot of predicted versus observed 4-year mortality was constructed from individual values of SSII in EXCEL. To assess overestimation versus underestimation of predicted mortality risk, an optimal fit regression line with slope and intercept was determined. Prospective treatment recommendations based on SSII were compared with actual treatments and all-cause mortality at 4 years., Results: SSII variables were available from EXCEL trial in 1807/1905 (95%) patients. For the entire cohort, discrimination was possibly helpful (C statistic = 0.670). SSII-predicted all-cause mortality at 4 years overestimated the observed mortality, particularly in the highest-risk percentiles, as confirmed by the fit regression line [intercept 2.37 (1.51-3.24), P = 0.003; slope 0.67 (0.61-0.74), P < 0.001]. When the SSII-recommended treatment was CABG, randomized EXCEL patients treated with PCI had a trend towards higher mortality compared with those treated with CABG (14.1% vs 5.3%, P = 0.07) in the as-treat population. In the intention-to-treat population, patients randomized to PCI had higher mortality compared with those randomized to CABG (15.1% vs 4.1%, P = 0.02), when SSII recommended CABG., Conclusions: In the EXCEL trial of patients with left main disease, the SSII-predicted 4-year mortality overestimated the 4-year observed mortality with a possibly helpful discrimination. Non-compliance with SSII CABG treatment recommendations (i.e. randomized to PCI) was associated with higher 4-year all-cause mortality., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)
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- 2020
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41. Fifty-Sixth Annual Meeting, The Society of Thoracic Surgeons.
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Sabik JF 3rd
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- Congresses as Topic, Humans, Louisiana, Cardiac Surgical Procedures methods, Societies, Medical, Surgeons, Thoracic Surgery
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- 2020
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42. Effect of Baseline Anemia on Outcomes After Left Main Coronary Revascularization.
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Gaba P, Serruys PW, Sabik JF 3rd, Kappetein AP, Chen S, Morice MC, Kandzari DE, Crowley A, Mehran R, and Stone GW
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- Anemia blood, Anemia mortality, Coronary Artery Bypass mortality, Coronary Artery Disease blood, Coronary Artery Disease mortality, Humans, Percutaneous Coronary Intervention mortality, Treatment Outcome, Anemia surgery, Coronary Artery Bypass trends, Coronary Artery Disease surgery, Percutaneous Coronary Intervention trends
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- 2020
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43. Mortality After Repeat Revascularization Following PCI or CABG for Left Main Disease: The EXCEL Trial.
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Giustino G, Serruys PW, Sabik JF 3rd, Mehran R, Maehara A, Puskas JD, Simonton CA, Lembo NJ, Kandzari DE, Morice MC, Taggart DP, Gershlick AH, Ragosta M 3rd, Kron IL, Liu Y, Zhang Z, McAndrew T, Dressler O, Généreux P, Ben-Yehuda O, Pocock SJ, Kappetein AP, and Stone GW
- Subjects
- Aged, Coronary Angiography, Coronary Artery Bypass adverse effects, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease mortality, Drug-Eluting Stents, Female, Humans, Male, Middle Aged, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention instrumentation, Reoperation adverse effects, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Coronary Artery Bypass mortality, Coronary Artery Disease therapy, Percutaneous Coronary Intervention mortality, Reoperation mortality
- Abstract
Objectives: The aim of this study was to investigate the incidence and impact on mortality of repeat revascularization after index percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD)., Background: The impact on mortality of the need of repeat revascularization following PCI or CABG in patients with unprotected LMCAD is unknown., Methods: All patients with LMCAD and site-assessed low or intermediate SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) scores randomized to PCI (n = 948) or CABG (n = 957) in the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial were included. Repeat revascularization events were adjudicated by an independent clinical events committee. The effect of repeat revascularization on mortality through 3-year follow-up was examined in time-varying Cox regression models., Results: During 3-year follow-up, there were 346 repeat revascularization procedures among 185 patients. PCI was associated with higher rates of any repeat revascularization (12.9% vs. 7.6%; hazard ratio: 1.73; 95% confidence interval: 1.28 to 2.33; p = 0.0003). Need for repeat revascularization was independently associated with increased risk for 3-year all-cause mortality (adjusted hazard ratio: 2.05; 95% confidence interval: 1.13 to 3.70; p = 0.02) and cardiovascular mortality (adjusted hazard ratio: 4.22; 95% confidence interval: 2.10 to 8.48; p < 0.0001) consistently after both PCI and CABG (p
int = 0.85 for both endpoints). Although target vessel revascularization and target lesion revascularization were both associated with an increased risk for mortality, target vessel non-target lesion revascularization and non-target vessel revascularization were not., Conclusions: In the EXCEL trial, repeat revascularization during follow-up was performed less frequently after CABG than PCI and was associated with increased mortality after both procedures. Reducing the need for repeat revascularization may further improve long-term survival after percutaneous or surgical treatment of LMCAD. (EXCEL Clinical Trial; NCT01205776)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2020
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44. Contemporary Trends and Outcomes of Percutaneous and Surgical Aortic Valve Replacement in Patients With Cancer.
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Guha A, Dey AK, Arora S, Cavender MA, Vavalle JP, Sabik JF III,, Jimenez E, Jneid H, and Addison D
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- Aged, Aged, 80 and over, Aortic Valve diagnostic imaging, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis mortality, Databases, Factual, Female, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation mortality, Hospital Mortality, Humans, Inpatients, Male, Middle Aged, Neoplasms diagnosis, Neoplasms mortality, Postoperative Complications mortality, Risk Assessment, Risk Factors, Time Factors, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement mortality, Treatment Outcome, United States epidemiology, Aortic Valve surgery, Aortic Valve Stenosis surgery, Heart Valve Prosthesis Implantation trends, Neoplasms epidemiology, Outcome and Process Assessment, Health Care trends, Transcatheter Aortic Valve Replacement trends
- Abstract
Background Patients with cancer and severe aortic stenosis are often ineligible for surgical aortic valve replacement (SAVR). Patients with cancer may likely benefit from emerging transcatheter aortic valve replacement (TAVR), given its minimally invasive nature. Methods and Results The US-based National Inpatient Sample was queried between 2012 and 2015 using International Classification of Diseases, Ninth Revision, Clinical Modification ( ICD-9-CM ), codes to identify all hospitalized adults (aged ≥50 years), who had a primary diagnosis of aortic stenosis. We examined the effect modification of cancer on the relative use rate, outcomes, and dispositions associated with propensity-matched cohort TAVR versus SAVR. Overall, 47 295 TAVRs (22.6% comorbid cancer) and 113 405 SAVRs (15.2% comorbid cancer) were performed among admissions with aortic stenosis between 2012 and 2015. In the year 2015, patients with cancer saw relatively higher rates of TAVR use compared with SAVR (relative use rate
TAVR versus relative use rateSAVR , 67.8% versus 57.2%; P <0.0001). Among patients with cancer, TAVR was associated with lower odds of acute kidney injury (odds ratio, 0.64; 95% CI, 0.54-0.75) and major bleeding (odds ratio, 0.44; 95% CI, 0.38-0.51]), with no differences in in-hospital mortality and stroke compared with SAVR. In addition, TAVR was associated with higher odds of home discharge (odds ratio, 1.92; 95% CI, 1.68-2.19) compared with SAVR among patients with cancer. Lower risk of acute kidney injury was noted in cancer versus noncancer ( P <0.001) undergoing TAVR versus SAVR in effect modification analysis. Conclusions TAVR use has increased irrespective of cancer status, with a greater increase in cancer versus noncancer. In patients with cancer, there was an association of TAVR with lower periprocedural complications and better disposition when compared with patients undergoing SAVR.- Published
- 2020
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45. Stability After Initial Decline in Coronary Revascularization Rates in the United States.
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Raza S, Deo SV, Kalra A, Zia A, Altarabsheh SE, Deo VS, Mustafa RR, Younes A, Rao SV, Markowitz AH, Park SJ, Costa MA, Simon DI, Bhatt DL, and Sabik JF 3rd
- Subjects
- Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, United States, Coronary Artery Bypass statistics & numerical data, Percutaneous Coronary Intervention statistics & numerical data, Procedures and Techniques Utilization statistics & numerical data
- Abstract
Background: It remains uncertain how advances in revascularization techniques, availability of new evidence, and updated guidelines have influenced the annual rates of coronary revascularization in the United States., Methods: We used the Nationwide Inpatient Sample data from 2005 to 2014 with appropriate weighting to determine national procedural volumes. To present accurately overall percutaneous coronary intervention (PCI) rates, PCI with same-day discharge numbers per year were estimated from the available literature and added to annual PCI procedures performed., Results: Annual PCI rate declined from 353 per 100,000 adults in 2005 to 277 per 100,000 adults in 2009 (P < .001) but remained stable thereafter (P = .50). Annual coronary artery bypass grafting (CABG) rate declined steadily, at a shallower slope than PCI, from 120 per 100,000 in 2005 to 93 per 100,000 in 2009 (P = .02) but remained stable thereafter (P = .60). Similar trends were seen in men and women. Both PCI and CABG rates were lower in women than men over the study period (PCI, 482 to 324/100,000 in men vs 232 to 153/100,000 in women; CABG, 172 to 118/100,000 in men vs 64 to 38/100,000 in women). Annual PCI rates were higher than CABG rates in patients of all age groups including in younger patients (age < 50) and octogenarians. The proportion of coronary revascularization procedures performed per insurance type remained relatively similar across the study period., Conclusions: Annual rates of coronary revascularization have changed significantly over time, potentially because of advances in revascularization techniques, availability of new evidence, and updated guidelines. Rates of PCI declined more steeply than CABG before plateauing but remained higher than rates of CABG across the study period., (Copyright © 2019 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)
- Published
- 2019
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46. Association of Acute Venous Thromboembolism With In-Hospital Outcomes of Coronary Artery Bypass Graft Surgery.
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Panhwar MS, Ginwalla M, Kalra A, Gupta T, Kolte D, Khera S, Bhatt DL, and Sabik JF 3rd
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- Aged, Coronary Artery Bypass mortality, Databases, Factual, Female, Hospital Costs, Hospital Mortality, Humans, Incidence, Inpatients, Length of Stay, Male, Middle Aged, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, United States epidemiology, Venous Thromboembolism economics, Venous Thromboembolism mortality, Venous Thromboembolism therapy, Coronary Artery Bypass adverse effects, Venous Thromboembolism epidemiology
- Abstract
Background While venous thromboembolism (VTE) prophylaxis is a strong recommendation after most surgeries, it is controversial in cardiac surgeries such as coronary artery bypass grafting (CABG), because of perceived low VTE incidence and increased bleeding risk. Prior studies may not have been adequately powered to study outcomes of VTE in this population. We sought to investigate the postoperative incidence and outcomes of CABG patients using a large national inpatient database. Methods and Results We utilized the 2013 to 2014 National Inpatient Sample to identify all patients >18 years of age who underwent CABG (without concomitant valvular procedures), and had VTE during the hospital stay. We then compared clinically relevant outcomes in patients with and without VTE. We identified 331 950 CABG procedures. Of these, 1.3% (n=4205) had VTE. Patients with VTE were more likely to be older (mean 67.2±10.4 years versus 65.2±10.4 years, P <0.001). VTE was associated with higher incidence of inpatient mortality (6.8% versus 1.7%; adjusted odds ratio 1.92 [95% CI 1.40-2.65]; P <0.001) and complications. VTE was also associated with higher cost (mean±SE $81 995±$923 versus $48 909±$55) and longer length of stay (mean±SE 17.06±0.16 days versus 8.52±0.01 days). Conclusions Our analysis of >330 000 CABG procedures suggests that while postoperative VTE after CABG is rare, it is associated with increased morbidity and mortality. Randomized controlled trials are needed to identify optimal strategies for VTE prophylaxis in these patients.
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- 2019
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47. Left Main Coronary Artery Disease Revascularization According to the SYNTAX Score.
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Shlofmitz E, Généreux P, Chen S, Dressler O, Ben-Yehuda O, Morice MC, Puskas JD, Taggart DP, Kandzari DE, Crowley A, Redfors B, Mehdipoor G, Kappetein AP, Sabik JF 3rd, Serruys PW, and Stone GW
- Subjects
- Aged, Cardiovascular Agents administration & dosage, Clinical Decision-Making, Coronary Angiography, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease mortality, Drug-Eluting Stents, Everolimus administration & dosage, Female, Humans, Male, Middle Aged, Patient Selection, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Coronary Artery Bypass adverse effects, Coronary Artery Bypass mortality, Coronary Artery Disease therapy, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention instrumentation, Percutaneous Coronary Intervention mortality
- Abstract
Background: The SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS), a measure of anatomic coronary artery disease (CAD) extent and complexity, has proven useful in past studies to determine the absolute and relative prognosis after revascularization with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). We sought to assess contemporary outcomes after PCI and CABG in patients with left main CAD according to SS and revascularization type from a large randomized trial., Methods: The EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) randomized patients with left main CAD and site-assessed SS≤32 to PCI with everolimus-eluting stents or CABG. Four-year outcomes were examined according to angiographic core laboratory-assessed SS using multivariable Cox proportional hazards regression., Results: A total of 1840 patients with left main CAD randomized to PCI (n=914) versus CABG (n=926) had angiographic core laboratory SS assessment. The mean SS was 26.5±9.3 (range 5-74); 24.1% of patients had angiographic core laboratory-assessed SS ≥33. The 4-year rate of the primary major adverse cardiac event end point of death, stroke, or myocardial infarction was similar between PCI and CABG (18.6% versus 16.7%, respectively; P=0.40) and did not vary according to SS (P
interaction =0.33). Rates of ischemia-driven revascularization rose with increasing SS after PCI, but not after CABG. As a result, the major secondary composite end point of major adverse cardiac or cerebrovascular events (major adverse cardiac event or ischemia-driven revascularization) occurred more frequently with PCI than CABG (28.0% versus 22.0%, P=0.01), a difference which rose progressively with increasing SS (Pinteraction =0.03)., Conclusions: In the EXCEL trial, the 4-year primary composite major adverse cardiac event end point of death, myocardial infarction, or stroke was similar after PCI with everolimus-eluting stents and CABG and was independent of the baseline anatomic complexity and extent of CAD. In contrast, the relative and absolute hazard of major adverse cardiac or cerebrovascular events with PCI compared with CABG rose progressively with the SS. These data should be considered by the heart team when deciding between PCI versus CABG for revascularization in patients with left main CAD., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier NCT01205776.- Published
- 2019
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48. Off-Pump Versus On-Pump Bypass Surgery for Left Main Coronary Artery Disease.
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Benedetto U, Puskas J, Kappetein AP, Brown WM 3rd, Horkay F, Boonstra PW, Bogáts G, Noiseux N, Dressler O, Angelini GD, Stone GW, Serruys PW, Sabik JF, and Taggart DP
- Subjects
- Aged, Cause of Death trends, Coronary Artery Bypass, Off-Pump methods, Coronary Artery Disease mortality, Female, Global Health, Humans, Male, Middle Aged, Prognosis, Survival Rate trends, Treatment Outcome, Coronary Artery Bypass methods, Coronary Artery Disease surgery, Percutaneous Coronary Intervention methods
- Abstract
Background: Concerns remain for a greater risk of incomplete revascularization and reduced survival with off-pump coronary artery bypass grafting (CABG) surgery compared with on-pump surgery particularly in patients with left main disease and extensive underlying myocardial ischemia., Objectives: This study sought to compare outcomes following off-pump versus on-pump surgery for left main disease by performing a post hoc analysis from the multicenter, randomized EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial., Methods: The EXCEL trial was designed to compare percutaneous coronary intervention with everolimus-eluting stents versus CABG in patients with left main disease. CABG was performed with or without cardiopulmonary bypass (on-pump vs. off-pump surgery) according to the discretion of the operator. The 3-year outcomes in the off-pump and on-pump groups were compared using inverse probability of treatment weighting (IPTW) for treatment effect estimation., Results: Among 923 CABG patients, 652 and 271 patients underwent on-pump and off-pump surgery, respectively. Despite a similar extent of disease, off-pump surgery was associated with a lower rate of revascularization of the left circumflex coronary artery (84.1% vs. 90.0%; p = 0.01) and right coronary artery (31.1% vs. 40.6%; p = 0.007). After IPTW adjustment for baseline differences, off-pump surgery was associated with a significantly increased risk of 3-year all-cause death (8.8% vs. 4.5%; hazard ratio: 1.94; 95% confidence interval: 1.10 to 3.41; p = 0.02) and a nonsignificant difference in the risk for the composite endpoint of death, myocardial infarction, or stroke (11.8% vs. 9.2%; hazard ratio: 1.28; 95% confidence interval: 0.82 to 2.00; p = 0.28)., Conclusions: Among patients with left main disease treated with CABG in the EXCEL trial, off-pump surgery was associated with a lower rate of revascularization of the coronary arteries supplying the inferolateral wall and an increased risk of 3-year all-cause death compared with on-pump surgery., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2019
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49. Impact of large periprocedural myocardial infarction on mortality after percutaneous coronary intervention and coronary artery bypass grafting for left main disease: an analysis from the EXCEL trial.
- Author
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Ben-Yehuda O, Chen S, Redfors B, McAndrew T, Crowley A, Kosmidou I, Kandzari DE, Puskas JD, Morice MC, Taggart DP, Leon MB, Lembo NJ, Brown WM, Simonton CA, Dressler O, Kappetein AP, Sabik JF, Serruys PW, and Stone GW
- Subjects
- Aged, Case-Control Studies, Coronary Artery Disease blood, Coronary Artery Disease diagnostic imaging, Creatine Kinase, MB Form analysis, Drug-Eluting Stents adverse effects, Everolimus therapeutic use, Female, Humans, Male, Middle Aged, Mortality trends, Myocardial Infarction epidemiology, Myocardial Infarction metabolism, Perioperative Period statistics & numerical data, Prognosis, Prospective Studies, Pulmonary Disease, Chronic Obstructive complications, Stroke Volume physiology, Ventricular Function, Left physiology, Coronary Artery Bypass adverse effects, Coronary Artery Disease therapy, Myocardial Infarction etiology, Myocardial Infarction mortality, Percutaneous Coronary Intervention adverse effects
- Abstract
Aims: The prognostic implications of periprocedural myocardial infarction (PMI) after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) remain controversial. We examined the 3-year rates of mortality among patients with and without PMI undergoing left main coronary artery intervention randomized to PCI with everolimus-eluting stents vs. CABG in the large-scale, multicentre, prospective, randomized EXCEL trial., Methods and Results: By protocol, PMI was defined using an identical threshold for PCI and CABG [creatinine kinase-MB (CK-MB) elevation >10× the upper reference limit (URL) within 72 h post-procedure, or >5× URL with new Q-waves, angiographic vessel occlusion, or loss of myocardium on imaging]. Cox proportional hazards modelling was performed controlling for age, sex, hypertension, diabetes mellitus, left ventricular ejection fraction, SYNTAX score, and chronic obstructive pulmonary disease (COPD). A total of 1858 patients were treated as assigned by randomization. Periprocedural MI occurred in 34/935 (3.6%) of patients in the PCI group and 56/923 (6.1%) of patients in the CABG group [odds ratio 0.61, 95% confidence interval (CI) 0.40-0.93; P = 0.02]. Periprocedural MI was associated with SYNTAX score, COPD, cross-clamp duration and total procedure duration, and not using antegrade cardioplegia. By multivariable analysis, PMI was associated with cardiovascular death and all-cause death at 3 years [adjusted hazard ratio (HR) 2.63, 95% CI 1.19-5.81; P = 0.02 and adjusted HR 2.28, 95% CI 1.22-4.29; P = 0.01, respectively]. The effect of PMI was consistent for PCI and CABG for cardiovascular death (Pinteraction = 0.56) and all-cause death (Pinteraction = 0.59). Peak post-procedure CK-MB ≥10× URL strongly predicted mortality, whereas lesser degrees of myonecrosis were not associated with prognosis., Conclusion: In the EXCEL trial, PMI was more common after CABG than PCI, and was strongly associated with increased 3-year mortality after controlling for potential confounders. Only extensive myonecrosis (CK-MB ≥10× URL) was prognostically important., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2019
- Full Text
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50. Impact of chronic obstructive pulmonary disease on prognosis after percutaneous coronary intervention and bypass surgery for left main coronary artery disease: an analysis from the EXCEL trial.
- Author
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Huang X, Redfors B, Chen S, Liu Y, Ben-Yehuda O, Puskas JD, Kandzari DE, Merkely B, Horkay F, van Boven AJ, Boonstra PW, Sabik JF, Serruys PW, Kappetein AP, and Stone GW
- Subjects
- Aged, Coronary Angiography, Coronary Artery Disease complications, Coronary Artery Disease diagnosis, Coronary Vessels diagnostic imaging, Coronary Vessels surgery, Female, Humans, Incidence, Male, Prognosis, Risk Factors, Severity of Illness Index, Survival Rate trends, Time Factors, Treatment Outcome, United States epidemiology, Coronary Artery Disease surgery, Drug-Eluting Stents, Percutaneous Coronary Intervention methods, Postoperative Complications epidemiology, Propensity Score, Pulmonary Disease, Chronic Obstructive complications, Risk Assessment methods
- Abstract
Objectives: Percutaneous coronary intervention (PCI) is often favoured over coronary artery bypass grafting (CABG) surgery for revascularization in patients with chronic obstructive pulmonary disease (COPD). We studied whether COPD affected clinical outcomes according to revascularization in the Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial, in which PCI with everolimus-eluting stents was non-inferior to CABG for the treatment of patients with left main coronary artery disease and low or intermediate SYNTAX scores., Methods: Patients with a history of COPD were propensity score matched to those without COPD. Outcomes at 30 days and 3 years in both groups were compared in patients randomized to PCI versus CABG., Results: COPD status was available for 1901 of 1905 randomized patients (99.8%), 148 of whom had COPD (7.8%). Propensity score matching yielded 135 patients with COPD and 675 patients without COPD. Patients with COPD had higher 3-year rates of the primary composite end point of death, myocardial infarction or stroke (31.7% vs 14.5%, P < 0.0001), death (17.1% vs 7.5%, P = 0.0005) and myocardial infarction (18.3% vs 7.3%, P < 0.0001), but not stroke (3.3% vs 2.9%, P = 0.84). There were no statistically significant interactions in the relative risks of PCI versus CABG for the primary composite end point in patients with and without COPD at 30 days [hazard ratio (HR) 0.39, 95% confidence interval (CI) 0.12-1.21 vs HR 0.55, 95% CI 0.29-1.06; Pinteraction = 0.61] or at 3 years (HR 0.85, 95% CI 0.46-1.56 vs HR 1.28, 95% CI 0.84-1.94; Pinteraction = 0.27)., Conclusions: In the EXCEL trial, COPD was independently associated with poor prognosis after left main coronary artery disease revascularization. The relative risks of PCI versus CABG at 30 days and 3 years were consistent in patients with and without COPD., Clinical Trial Registration Number: http://www.clinicaltrials.gov; NCT01205776., (© The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)
- Published
- 2019
- Full Text
- View/download PDF
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