790 results on '"Mack MJ"'
Search Results
2. Mortality 10 Years After Percutaneous or Surgical Revascularization in Patients With Total Coronary Artery Occlusions
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Kawashima, H, Takahashi, K, Ono, M, Hara, H, Wang, R, Gao, C, Sharif, F, Mack, MJ, Holmes, DR, Jr, Morice, MC, Head, SJ, Kappetein, AP, Thuijs, Daan, Milojevic, Milan, Noack, T, Mohr, FW, Davierwala, PM, Serruys, PWJC, Onuma, Y, Kawashima, H, Takahashi, K, Ono, M, Hara, H, Wang, R, Gao, C, Sharif, F, Mack, MJ, Holmes, DR, Jr, Morice, MC, Head, SJ, Kappetein, AP, Thuijs, Daan, Milojevic, Milan, Noack, T, Mohr, FW, Davierwala, PM, Serruys, PWJC, and Onuma, Y
- Abstract
Background: The long-term clinical benefit after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in patients with total occlusions (TOs) and complex coronary artery disease has not yet been clarified. Objectives: The objective of this analysis was to assess 10-year all-cause mortality in patients with TOs undergoing PCI or CABG. Methods: This is a subanalysis of patients with at least 1 TO in the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) study, which investigated 10-year all-cause mortality in the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trial, beyond its original 5-year follow-up. Patients with TOs were further stratified according to the status of TO recanalization or revascularization. Results: Of 1,800 randomized patients to the PCI or CABG arm, 460 patients had at least 1 lesion of TO. In patients with TOs, the status of TO recanalization or revascularization was not associated with 10-year all-cause mortality, irrespective of the assigned treatment (PCI arm: 29.9% vs. 29.4%; adjusted hazard ratio [HR]: 0.992; 95% confidence interval [CI]: 0.474 to 2.075; p = 0.982; and CABG arm: 28.0% vs. 21.4%; adjusted HR: 0.656; 95% CI: 0.281 to 1.533; p = 0.330). When TOs existed in left main and/or left anterior descending artery, the status of TO recanalization or revascularization did not have an impact on the mortality (34.5% vs. 26.9%; adjusted HR: 0.896; 95% CI: 0.314 to 2.555; p = 0.837). Conclusions: At 10-year follow-up, the status of TO recanalization or revascularization did not affect mortality, irrespective of the assigned treatment and location of TOs. The present study might support contemporary practice among high-volume chronic TO-PCI centers where recanalization is primarily offered to patients for the management of angina refractory to medical therapy when myocardial viability is confirmed.
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- 2021
3. Revascularization for unprotected left main stem coronary artery stenosis stenting or surgery
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Taggart, DP, Kaul, S, Boden, WE, Ferguson, TB, Guyton, RA, Mack, MJ, Sergeant, PT, Shemin, RJ, Smith, PK, and Yusuf, S
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surgical procedures, operative - Abstract
For coronary artery disease with unprotected left main stem (LMS) stenosis, coronary artery bypass grafting (CABG) is traditionally regarded as the "standard of care" because of its well-documented and durable survival advantage. There is now an increasing trend to use drug-eluting stents for LMS stenosis rather than CABG despite very little high-quality data to inform clinical practice. We herein: 1) evaluate the current evidence in support of the use of percutaneous revascularization for unprotected LMS; 2) assess the underlying justification for randomized controlled trials of stenting versus surgery for unprotected LMS; and 3) examine the optimum approach to informed consent. We conclude that CABG should indeed remain the preferred revascularization treatment in good surgical candidates with unprotected LMS stenosis.
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- 2016
4. Causes of Death Following PCI Versus CABG in Complex CAD 5-Year Follow-Up of SYNTAX
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Milojevic, Milan, Head, Stuart, Parasca, Catalina, Serruys, PWJC (Patrick), Mohr, FW, Morice, MC, Mack, MJ, Stahle, E, Feldman, E, Feldman, TE, Dawkins, KD, Colombo, A, Kappetein, Arie-Pieter, Holmes, DR, Cardiothoracic Surgery, and Cardiology
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surgical procedures, operative ,SDG 3 - Good Health and Well-being ,cardiovascular diseases - Abstract
BACKGROUND There are no data available on specific causes of death from randomized trials that have compared coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI). OBJECTIVES The purpose of this study was to investigate specific causes of death, and its predictors, after revascularization for complex coronary disease in patients. METHODS An independent Clinical Events Committee consisting of expert physicians who were blinded to the study treatment subclassified causes of death as cardiovascular (cardiac and vascular), noncardiovascular, or undetermined according to the trial protocol. Cardiac deaths were classified as sudden cardiac, related to myocardial infarction (MI), and other cardiac deaths. RESULTS In the randomized cohort, there were 97 deaths after CABG and 123 deaths after PCI during a 5-year follow-up. After CABG, 49.4% of deaths were cardiovascular, with the greatest cause being heart failure, arrhythmia, or other causes (24.6%), whereas after PCI, the majority of deaths were cardiovascular (67.5%) and as a result of MI (29.3%). The cumulative incidence rates of all-cause death were not significantly different between CABG and PCI (11.4% vs. 13.9%, respectively; p = 0.10), whereas there were significant differences in terms of cardiovascular (5.8% vs. 9.6%, respectively; p = 0.008) and cardiac death (5.3% vs. 9.0%, respectively; p = 0.003), which were caused primarily by a reduction in MI-related death with CABG compared with PCI (0.4% vs. 4.1%, respectively; p
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- 2016
5. Incidence, Characteristics, Predictors, and Outcomes of Repeat Revascularization After Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting The SYNTAX Trial at 5 Years
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Parasca, Catalina, Head, Stuart, Milojevic, Milan, Mack, MJ, Serruys, PWJC (Patrick), Morice, M-C, Mohr, FW, Feldman, TE, Colombo, A, Dawkins, KD, Holmes, DR, Jr, Kappetein, Arie-Pieter, Cardiothoracic Surgery, and Cardiology
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- 2016
6. Incidence, predictors and outcomes of incomplete revascularization after percutaneous coronary intervention and coronary artery bypass grafting: a subgroup analysis of 3-year SYNTAX data
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Head, Stuart, Mack, MJ, Holmes, DR, Mohr, FW, Morice, MC, Serruys, PWJC (Patrick), Kappetein, Arie-Pieter, Pagano, D, Taggart, DP, Cardiothoracic Surgery, and Cardiology
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Male ,Reoperation ,Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Randomization ,medicine.medical_treatment ,Coronary Artery Disease ,Revascularization ,Coronary artery bypass surgery ,Risk Factors ,Angioplasty ,Internal medicine ,medicine ,Humans ,cardiovascular diseases ,Myocardial infarction ,Angioplasty, Balloon, Coronary ,Coronary Artery Bypass ,Aged ,Unstable angina ,business.industry ,Percutaneous coronary intervention ,Drug-Eluting Stents ,General Medicine ,Middle Aged ,Prognosis ,medicine.disease ,Surgery ,Treatment Outcome ,surgical procedures, operative ,Cardiovascular Diseases ,Conventional PCI ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business ,Follow-Up Studies - Abstract
OBJECTIVE: To assess whether incomplete revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) has an effect on long-term outcomes. METHODS: During a heart team discussion to evaluate whether patients were eligible for randomization in the SYNTAX trial, both the cardiologist and surgeon agreed on which vessels needed revascularization. This statement was compared with the actual revascularization after treatment. Incomplete revascularization was defined as when a preoperatively identified vessel with a lesion was not revascularized. Outcomes were major adverse cardiac or cerebrovascular events (MACCE), the composite safety endpoint of death/ stroke/myocardial infarction (MI), and individual MACCE components death, MI and repeat revascularization at 3 years. Predictors of incomplete revascularization were explored. RESULTS: Incomplete revascularization was found in 43.3% (388/896) PCI and 36.8% (320/870) CABG patients. Patients with complete revascularization by PCI had lower rates of MACCE (66.5 versus 76.2%, P< 0.001), the composite safety endpoint (83.4 versus 87.9%, P = 0.05) and repeat revascularization (75.5 versus 83.9%, P< 0.001), but not death and MI. In the CABG group, no difference in outcomes was seen between incomplete and complete revascularization groups. Incomplete revascularization was identified as independent predictor of MACCE in PCI (HR = 1.55, 95% CI 1.15–2.08, P = 0.004) but not CABG patients. Independent predictors of incomplete revascularization by PCI were hyperlipidaemia (OR = 1.59, 95% CI 1.04–2.42, P = 0.031), a total occlusion (OR = 2.46, 95% CI 1.66–3.64, P < 0.001) and the number of vessels (OR = 1.58, 95% CI 1.41–1.77, P< 0.001). Independent predictors of incomplete revascularization by CABG were unstable angina (OR = 1.42, 95% CI 1.02–1.98, P= 0.038), diffuse disease or narrowed ( < 2 mm) segment distal to the lesion (OR = 1.87, 95% CI 1.31–2.69, P = 0.001) and the number of vessels (OR = 1.70, 95% CI 1.53–1.89, P < 0.001). CONCLUSIONS: Despite the hypothesis-generating nature of this data, this study demonstrates that incomplete revascularization is associated with adverse events during follow-up after PCI but not CABG.
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- 2011
7. 2012 ACCF/AATS/SCAI/STS Expert Consensus Document on Transcatheter Aortic Valve Replacement
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Holmes, DR, Mack, MJ, Kaul, S, Agnihotri, A, Alexander, KP, Bailey, SR, Calhoon, JH, Carabello, BA, Desai, MY, Edwards, FH, Francis, GS, Gardner, TJ, Kappetein, Arie-Pieter, Linderbaum, JA, Mukherjee, C, Mukherjee, D, Otto, CM, Ruiz, CE, Sacco, RL, Smith, D, Thomas, JD, Harrington, RA, Bhatt, L, Ferrari, VA, Fisher, JD, Garcia, MJ, Gentile, F, Gilson, MF, Hernandez, A, Jacobs, AK, Moliterno, DJ, Weitz, HH, and Cardiothoracic Surgery
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- 2012
8. SYNTAX run-in phase: Insights into contemporary practice patterns in Europe and North America for 3-vessel and left main coronary disease
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Serruys, PWJC (Patrick), Mohr, FW, Morice, MC, Kappetein, Arie-Pieter, Holmes, DR, Mack, MJ, Dawkins, KD, Stahle, E, Colombo, A, Pomar, JL, van den Brand, M, Koglin, J, Russell, MW, Cardiology, and Cardiothoracic Surgery
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- 2005
9. The rationale for Heart Team decision-making for patients with stable, complex coronary artery disease
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Head, Stuart, Kaul, S, Mack, MJ, Serruys, PWJC (Patrick), Taggart, DP, Holmes, DR, Leon, MB, Marco, J, Bogers, Ad, Kappetein, Arie-Pieter, Head, Stuart, Kaul, S, Mack, MJ, Serruys, PWJC (Patrick), Taggart, DP, Holmes, DR, Leon, MB, Marco, J, Bogers, Ad, and Kappetein, Arie-Pieter
- Abstract
Stable complex coronary artery disease can be treated with coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or medical therapy. Multidisciplinary decision-making has gained more emphasis over the recent years to select the most optimal treatment strategy for individual patients with stable complex coronary artery disease. However, the so-called Heart Team concept has not been widely implemented. Yet, decision-making has shown to remain suboptimal; there is large variability in PCI-to-CABG ratios, which may predominantly be the consequence of physician-related factors that have raised concerns regarding overuse, underuse, and inappropriate selection of revascularization. In this review, we summarize these and additional data to support the statement that a multidisciplinary Heart Team consisting of at least a clinical/non-invasive cardiologist, interventional cardiologist, and cardiac surgeon, can together better analyse and interpret the available diagnostic evidence, put into context the clinical condition of the patient as well as consider individual preference and local expertise, and through shared decision-making with the patient can arrive at a most optimal joint treatment strategy recommendation for patients with stable complex coronary artery disease. In addition, other aspects of Heart Team decision-making are discussed: the organization and logistics, involvement of physicians, patients, and assisting personnel, the need for validation, and its limitations.
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- 2013
10. Interaction between endothelin and vasodilators in the human internal mammary artery.
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He, GW, primary, Yang, CQ, additional, Mack, MJ, additional, Acuff, TE, additional, Ryan, WH, additional, and Starr, A, additional
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- 1994
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11. Inhibitory effects of calcium antagonists on alpha-adrenoceptor- mediated contraction in the human internal mammary artery.
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He, GW, primary, Acuff, TE, additional, Ryan, WH, additional, Yang, CQ, additional, Douthit, MB, additional, Bowman, RT, additional, and Mack, MJ, additional
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- 1994
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12. Relationship between vein graft failure and subsequent clinical outcomes after coronary artery bypass surgery.
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Lopes RD, Mehta RH, Hafley GE, Williams JB, Mack MJ, Peterson ED, Allen KB, Harrington RA, Gibson CM, Califf RM, Kouchoukos NT, Ferguson TB Jr, Alexander JH, Project of Ex Vivo Vein Graft Engineering via Transfection IV (PREVENT IV) Investigators, Lopes, Renato D, Mehta, Rajendra H, Hafley, Gail E, Williams, Judson B, Mack, Michael J, and Peterson, Eric D
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- 2012
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13. Saphenous vein grafts with multiple versus single distal targets in patients undergoing coronary artery bypass surgery: one-year graft failure and five-year outcomes from the Project of Ex-Vivo Vein Graft Engineering via Transfection (PREVENT) IV trial.
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Mehta RH, Ferguson TB, Lopes RD, Hafley GE, Mack MJ, Kouchoukos NT, Gibson CM, Harrington RA, Califf RM, Peterson ED, Alexander JH, Project of Ex-vivo Vein Graft Engineering via Transfection (PREVENT) IV Investigators, Mehta, Rajendra H, Ferguson, T Bruce, Lopes, Renato D, Hafley, Gail E, Mack, Michael J, Kouchoukos, Nicholas T, Gibson, C Michael, and Harrington, Robert A
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- 2011
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14. On-pump versus off-pump CABG.
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Puskas JD, Mack MJ, and Smith CR
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- 2010
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15. Transcatheter cardiac valve interventions.
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Brinkman WT and Mack MJ
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- 2009
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16. Intraoperative coronary graft assessment.
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Mack MJ and Mack, Michael J
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- 2008
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17. Efficacy and safety of pyridoxal 5'-phosphate (MC-1) in high-risk patients undergoing coronary artery bypass graft surgery: the MEND-CABG II randomized clinical trial.
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Alexander JH, Emery RW Jr, Carrier M, Ellis SJ, Mehta RH, Hasselblad V, Menasche P, Khalil A, Cote R, Bennett-Guerrero E, Mack MJ, Schuler G, Harrington RA, Tardif JC, MEND-CABG II Investigators, Alexander, John H, Emery, Robert W Jr, Carrier, Michel, Ellis, Stephen J, and Mehta, Rajendra H
- Abstract
Context: Coronary artery bypass graft (CABG) surgery is frequently performed and effective; however, perioperative complications related to ischemia-reperfusion injury, including myocardial infarction (MI), remain common and result in significant morbidity and mortality. MC-1, a naturally occurring pyridoxine metabolite and purinergic receptor antagonist, prevents cellular calcium overload and may reduce ischemia-reperfusion injury. Phase 2 trial data suggest that MC-1 may reduce death or MI in high-risk patients undergoing CABG surgery.Objective: To assess the efficacy and safety of MC-1 administered immediately before and for 30 days after surgery in patients undergoing CABG surgery.Design, Setting, and Participants: The MC-1 to Eliminate Necrosis and Damage in Coronary Artery Bypass Graft Surgery II Trial, a phase 3, multicenter, randomized, double-blind, placebo-controlled trial, with 3023 intermediate- to high-risk patients undergoing CABG surgery with cardiopulmonary bypass enrolled between October 2006 and September 2007 at 130 sites in Canada, the United States, and Germany.Interventions: Patients received either MC-1, 250 mg/d (n = 1519), or matching placebo (n = 1504) immediately before and for 30 days after CABG surgery.Main Outcome Measures: The primary efficacy outcome was cardiovascular death or nonfatal MI, defined as a creatine kinase (CK) MB fraction of at least 100 ng/mL or new Q waves through postoperative day 30.Results: The primary efficacy outcome occurred in 140 of 1510 patients (9.3%) in the MC-1 group and 133 of 1486 patients (9.0%) in the placebo group (risk ratio, 1.04; 95% confidence interval, 0.83-1.30; P = .76). All-cause mortality was higher among patients assigned to MC-1 than placebo at 4 days (1.0% vs 0.3%; P = .03) but was similar at 30 days (1.9% vs 1.5%; P = .44). There was no difference in the 8- to 24-hour CK-MB area under the curve between the MC-1 and placebo groups (median, 270 [interquartile range, 175-492] vs 268 [interquartile range, 170-456] hours x ng/mL; P = .11).Conclusion: In this population of intermediate- to high-risk patients undergoing CABG surgery, MC-1 did not reduce the composite of cardiovascular death or nonfatal MI.Trial Registration: clinicaltrials.gov Identifier: NCT00402506 [ABSTRACT FROM AUTHOR]- Published
- 2008
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18. Comparing on-pump and off-pump coronary artery bypass grafting: numerous studies but few conclusions. A scientific statement from the American Heart Association Council on Cardiovascular Surgery and Anesthesia in collaboration with the Interdisciplinary Working Group on Quality of Care and Outcomes Research.
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Sellke FW, DiMaio JM, Caplan LR, Ferguson TB, Gardner TJ, Hiratzka LF, Isselbacher EM, Lytle BW, Mack MJ, Murkin JM, Robbins RC, and American Heart Association
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- 2005
19. Implantable cardioverter-defibrillators.
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Mack MJ, Nash I, van Veldhuisen DJ, Voors AA, Patwala A, Schlosshan D, Williams SG, Bardy GH, Lee KL, Mark DB, Kadish AH, McClellan MB, and Tunis SR
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- 2005
20. Personal adjustment of chronically ill old people under home care.
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Mack MJ
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- 1953
21. Percutaneous mitral valve repair: a fertile field of innovative treatment strategies.
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Mack MJ
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- 2006
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22. Cardiac surgery: the future is minimal!
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Mack MJ and Mack, M J
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- 2000
23. Coronary sinus in the management of functional mitral regurgitation: the mother lode or fool's gold?
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Mack MJ
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- 2006
24. Sirolimus-eluting coronary stents.
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Mack MJ, Drenth DJ, Zijlstra F, Boonstra PW, Moses JW, and Leon MB
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- 2004
25. Coronary-artery bypass surgery versus stenting for multivessel disease.
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Mack MJ
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- 2001
26. 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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27. A comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: The Randomized, phase II study to Evaluate the sAfety and pharmacokinetics of oraL dabIGatran etexilate in patients after heart valve replacemeNt (RE-ALIGN)
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Van de Werf F, Brueckmann M, Connolly SJ, Friedman J, Granger CB, Härtter S, Harper R, Kappetein AP, Lehr T, Mack MJ, Noack H, and Eikelboom JW
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- 2012
28. Letter by Van de Werf et al regarding article, "using dabigatran in patients with stroke: a practical guide for clinicians".
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Van de Werf F, Connolly SJ, Kappetein AP, Brueckmann M, Mack MJ, Granger CB, Eikelboom J, Van de Werf, Frans, Connolly, Stuart J, Kappetein, Arie Pieter, Brueckmann, Martina, Mack, Michael J, Granger, Christopher B, and Eikelboom, John
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- 2012
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29. On-pump versus off-pump coronary artery bypass surgery in a matched sample of women: a comparison of outcomes.
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Mack MJ, Brown P, Houser F, Katz M, Kuglemass A, Simon A, Battaglia S, Tarkington L, Culler S, and Becker E
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- 2004
30. Patient selection and current practice strategy for off-pump coronary artery bypass surgery.
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Magee MJ, Coombs LP, Peterson ED, and Mack MJ
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- 2003
31. Transcatheter versus surgical aortic-valve replacement in high-risk patients.
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Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, and Akin JJ
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- 2011
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32. Cost-Effectiveness of Transcatheter Aortic Valve Replacement Compared With Surgical Aortic Valve Replacement in High-Risk Patients With Severe Aortic Stenosis: Results of the PARTNER (Placement of Aortic Transcatheter Valves) Trial (Cohort A)
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Reynolds MR, Magnuson EA, Lei Y, Wang K, Vilain K, Li H, Walczak J, Pinto DS, Thourani VH, Svensson LG, Mack MJ, Miller DC, Satler LE, Bavaria J, Smith CR, Leon MB, Cohen DJ, and PARTNER Investigators
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- 2012
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33. The clinical development of percutaneous heart valve technology: a position statement of the Society of Thoracic Surgeons (STS), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography and Interventions (SCAI)
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Vassiliades TA Jr., Block PC, Cohn LH, Adams DA, Borer JS, Feldman T, Holmes DR, Laskey WK, Lytle BW, Mack MJ, Williams DO, Society of Thoracic Surgeons, American Association for Thoracic Surgery, and Society for Cardiovascular Angiography and Interventions
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- 2005
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34. Beating-heart implantation of adjustable length mitral valve chordae: acute and chronic experience in an animal model
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Friedrich W. Mohr, Ottavio Alfieri, Francesco Maisano, Joerg Seeburger, Micaela Cioni, Hugo Vanermen, Volkmar Falk, Michael J. Mack, University of Zurich, Maisano, F, Cioni, M, Seeburger, J, Falk, V, Mohr, Fw, Mack, Mj, Alfieri, Ottavio, and Vanermen, H.
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Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,medicine.medical_treatment ,Prosthesis Implantation ,610 Medicine & health ,2705 Cardiology and Cardiovascular Medicine ,law.invention ,law ,Internal medicine ,Mitral valve ,medicine ,Cardiopulmonary bypass ,Animals ,Minimally Invasive Surgical Procedures ,Thoracotomy ,Papillary muscle ,Ultrasonography, Interventional ,Mitral regurgitation ,Mitral valve repair ,Cardiopulmonary Bypass ,Sheep ,business.industry ,Suture Techniques ,Mitral Valve Insufficiency ,General Medicine ,Prostheses and Implants ,Papillary Muscles ,Surgery ,10020 Clinic for Cardiac Surgery ,2746 Surgery ,Disease Models, Animal ,medicine.anatomical_structure ,2740 Pulmonary and Respiratory Medicine ,Cardiology ,Chordae Tendineae ,Mitral Valve ,Chordae tendineae ,Cardiology and Cardiovascular Medicine ,business - Abstract
Objective: This study aimed to determine the acute and chronic performance of a new system designed to conduct beating-heart implantation and off-pump adjustment of neochordal length. Methods: In 14 adult sheep (group A) selected to undergo beating-heart cardiopulmonary bypass, the left atrium was opened through a left thoracotomy. Two or more primary chordae in the A2 region were severed to produce a model of a flail leaflet. A chordal adjustment mechanism (V-Chordal, Valtech Cardio Ltd., Or-Yehuda, Israel) was affixed to the head of the papillary muscle. The system includes two adjustable neochordae. The distal end of the neochordae was sutured to the flail segment without estimating the appropriate length. The neochordal length was adjusted off-pump under real-time echo-guidance. The adjustment tool was removed and the atriotomy was closed with a purse-string suture. Control animals (group B, n=4) were implanted with the conventional neochordae. Animals in both groups were sacrificed 3 months after the procedure. Results: In both groups, prior to repair, mitral regurgitation (MR) was severe in all animals. In group A, following adjustment of neochordae, MR was absent in all animals, with the exception of two animals that had residual 2+ MR irresponsive to neochordae adjustments. In group B, MR was 2+ in two of the four animals following repair. At 3 months, mitral competence was stable in all animals. At necropsy, normal healing of the papillary head and leaflet was observed in both the groups. Conclusions: The V-Chordal system simplifies the process of neochordal implantation and precise off-pump adjustment of the neochordal length to correct MR occurring due to a flail leaflet. This technology may improve the technical feasibility for adoption of chordal repair during open or minimally invasive surgical procedures
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- 2017
35. Neochordae Implantation Made Easy with an Adjustable Device Early Report of Acute and Chronic Animal Experiments
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Paolo Denti, Friedrich W. Mohr, Hugo Vanermen, Michael J. Mack, Volkmar Falk, Ottavio Alfieri, Francesco Maisano, Joerg Seeburger, Maisano, F, Denti, P, Vanermen, Hk, Seeburger, J, Falk, V, Mohr, Fw, Mack, Mj, and Alfieri, Ottavio
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Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Mitral regurgitation ,Pathology ,Beating heart ,business.industry ,General Medicine ,medicine.disease ,Surgery ,law.invention ,law ,Cardiopulmonary bypass ,Medicine ,Mitral valve prolapse ,Implant ,Delivery system ,business ,Cardiology and Cardiovascular Medicine ,Tissue ingrowth - Abstract
Objective Neochordae implantation is a well-established surgical solution for the treatment of mitral valve prolapse. The main limitation to wide usage of the technique has been the difficulty associated with accurate determination of neochordal length. We describe a system specifically designed to facilitate rapid, uncomplicated implantation and off-pump, beating heart adjustment of neochordae. Methods Five swine underwent implantation of the adjustable neochordal system (V-Chordal; Valtech Cardio LTD, Israel) while on cardiopulmonary bypass after cutting native chordae to create a significant lesion. Neochordae length was adjusted with millimeter-level resolution, off-pump after discontinuation from bypass. Results In all animals, the implant was successful. Under echocardiographic monitoring, flail lesions were corrected in all cases, using the anatomic landmarks or the degree of mitral regurgitation for real-time guidance. At postmortem gross examination, the implant and the neochordae were completely healed with evidence of tissue ingrowth. Conclusions Preliminary animal experience suggests that the V-Chordal-adjustable neochordae system can be safely and effectively implanted, with accurate and precise adjustment of chordal length. The design of the device is suitable for a minimally invasive environment because of the long, flexible shafted design of the delivery system.
- Published
- 2010
36. 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
- Published
- 2011
37. Five-Year Outcomes of Measured and Predicted Prosthesis-Patient Mismatch following Transcatheter Aortic Valve Implantation.
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Al-Azizi K, Moubarak G, Mohiuddin A, Szerlip M, Potluri S, Harrington K, Schaffer J, Brinkman W, Alsaid A, Wang Z, Ladner J, Gunukula R, Parro C, Ma TW, Stoler R, Chugh Y, Banerjee S, Mixon T, Widmer RJ, Caldera A, Contreras JC, Krueger A, Gray W, DiMaio JM, and Mack MJ
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- Humans, Male, Female, Aged, 80 and over, Retrospective Studies, Survival Rate trends, Aged, Aortic Valve surgery, Postoperative Complications epidemiology, Incidence, Prosthesis Fitting, Risk Factors, Transcatheter Aortic Valve Replacement adverse effects, Aortic Valve Stenosis surgery, Heart Valve Prosthesis, Prosthesis Design
- Abstract
Data on the long-term outcomes of prosthesis patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI) remain controversial. This study aimed to investigate the incidence and clinical outcomes of measured PPM (PPM
M ) and predicted PPM (PPMP ) in patients who underwent TAVI. This is a retrospective analysis of 3,016 patients who underwent TAVI at a large health care system between 2012 and 2021. Effective orifice area indexed to body surface area (EOAi) was measured at discharge using the continuity equation. EOAi was predicted according to the published predictive tables for each model and size of the valve. Primary end point was 5-year survival rate. Mean age was 80 years, and 55.6% were male. The mean Society of Thoracic Surgeons risk score was 4.66%. 74.9% of patients received a balloon-expandable valve (BEV), and 25.1% received a self-expanding valve (SEV). The incidence of severe PPM was markedly lower when defined by predicted versus measured EOAi (0.8% vs 6.3%, p <0.001) and when assessed in SEV versus BEV (5.3% vs 6.6%, p = 0.02). Neither severe PPMp nor severe PPMM was associated with 5-year mortality (hazard ratio 1.26, 95% confidence interval 0.96 to 1.66, p = 0.095; hazard ratio 1.03, 95% confidence interval 0.42 to 2.49, p = 0.954, respectively), irrespective of the presence of high residual pressure gradient. Neither BEV nor SEV was associated with an increased 5-year mortality, irrespective of PPM definition or severity. In this large health care system analysis, neither severe PPMP nor severe PPMM was associated with 5-year all-cause mortality. There was no difference between BEV and SEV in terms of mortality, irrespective of the definition or severity of PPM., Competing Interests: Declaration of competing interest Dr. Al-Azizi: proctor/consultant Edwards Lifesciences, consultant/Advisory Board Medtronic, consultant Boston Scientific, and Speaker Bureau Philips. Dr. Szerlip: Edwards Lifesciences, proctor, speaker, and consultant; Abbott Vascular, advisory board, consultant, and proctor; Medtronic, steering committee; and Boston Scientific, speaker. Dr. Stoler: proctor and advisory board: MDT, BSCI, and Edwards; advisory board: Biotronik. Dr. Mack: Abbott, Trial Co-PI; Edwards Life Sciences, Trial Co-PI; and Medtronic, Trial Study Chair; all uncompensated. Dr. Potluri: advisory board, proctor, and speaker: Medtronic, Boston Scientific, Abbott, and Cordis; proctor and speaker: Edwards, Terumo, and AstraZeneca. The remaining authors have no competing interests to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)- Published
- 2024
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38. Transcatheter Valve-in-Valve Replacement With Balloon- Versus Self-Expanding Valves in Patients With Degenerated Stentless Aortic Bioprosthesis.
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Moubarak G, Salih M, Eisenga J, McCullough K, Ramos OG, Banwait J, Al-Azizi K, Mack MJ, DiMaio JM, and Szerlip MI
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- Humans, Male, Female, Aged, Retrospective Studies, Aortic Valve surgery, Aged, 80 and over, Treatment Outcome, Transcatheter Aortic Valve Replacement methods, Bioprosthesis, Prosthesis Failure, Prosthesis Design, Heart Valve Prosthesis, Aortic Valve Stenosis surgery
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Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) has been associated with favorable outcomes in patients with degenerated stentless bioprosthesis. However, whether the outcomes after ViV TAVR for failed stentless bioprosthesis differ between balloon-expandable valves (BEVs) and self-expanding valves (SEVs) remains unknown. Therefore, we retrospectively analyzed 59 consecutive patients who underwent ViV TAVR for failed stentless bioprsothesis with BEVs (n = 42) versus SEVs (n = 17) in a single-health care system between 2013 and 2022. Overall, the mean age was 70.8 years and 74.6% were men. The mean transcatheter valve size was 26.3 ± 2.2 mm for BEVs and 26.4 ± 4 mm for SEVs (p = 0.93). The mean Society of Thoracic Surgeons score was 6.0 ± 3.6 for BEVs and 7.5 ± 5.5 for SEVs (p = 0.22). Compared with patients who received BEVs, those who received SEVs had higher rates of device malposition (2.4% vs 23.5%, p <0.01), postdeployment balloon dilation (11.9% vs 35.5%, p = 0.04) and need for a second transcatheter device (2.4% vs 35.5%, p <0.01). However, both groups showed similar improvement in aortic valve function at 30-day and 1-year follow-up (incidence of 1-year severe patient-prosthesis mismatch in BEVs: 17.6% vs 14.3% in SEVs, p = 0.78). The 1- and 3-year mortality did not differ between BEVs and SEVs (11.9% vs 11.8% and 25% vs 30%, respectively, Log rank p = 0.9). In conclusion, performing ViV TAVR for failed stentless bioprsothesis is technically challenging, especially when using SEVs; however, satisfactory positioning is possible in most cases, with excellent hemodynamic and clinical outcomes with BEVs and SEVs., Competing Interests: Declaration of competing interest Karim Al-Azizi is a proctor/consultant for Edwards Lifesciences, consultant/part of the advisory board for Medtronic, consultant for Boston Scientific, and part of the speaker bureau for Philips. Michael Mack is a trial coprincipal investigator for Abbott and Edwards Life sciences and a trial study chair for Medtronic—all uncompensated. Molly Szerlip is a proctor, speaker, and consultant for Edwards Lifesciences; part of the advisory board, consultant, and proctor for Abbott Vascular; part of the steering committee for Medtronic; and speaker and consultant for Boston Scientific. The remaining authors have no competing interest to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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39. Transcatheter Valve Replacement in Severe Tricuspid Regurgitation.
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Hahn RT, Makkar R, Thourani VH, Makar M, Sharma RP, Haeffele C, Davidson CJ, Narang A, O'Neill B, Lee J, Yadav P, Zahr F, Chadderdon S, Eleid M, Pislaru S, Smith R, Szerlip M, Whisenant B, Sekaran NK, Garcia S, Stewart-Dehner T, Thiele H, Kipperman R, Koulogiannis K, Lim DS, Fowler D, Kapadia S, Harb SC, Grayburn PA, Sannino A, Mack MJ, Leon MB, Lurz P, and Kodali SK
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Background: Severe tricuspid regurgitation is associated with disabling symptoms and an increased risk of death. Data regarding outcomes after percutaneous transcatheter tricuspid-valve replacement are needed., Methods: In this international, multicenter trial, we randomly assigned 400 patients with severe symptomatic tricuspid regurgitation in a 2:1 ratio to undergo either transcatheter tricuspid-valve replacement and medical therapy (valve-replacement group) or medical therapy alone (control group). The hierarchical composite primary outcome was death from any cause, implantation of a right ventricular assist device or heart transplantation, postindex tricuspid-valve intervention, hospitalization for heart failure, an improvement of at least 10 points in the score on the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS), an improvement of at least one New York Heart Association (NYHA) functional class, and an improvement of at least 30 m on the 6-minute walk distance. A win ratio was calculated for the primary outcome by comparing all possible patient pairs, starting with the first event in the hierarchy., Results: A total of 267 patients were assigned to the valve-replacement group and 133 to the control group. At 1 year, the win ratio favoring valve replacement was 2.02 (95% confidence interval [CI], 1.56 to 2.62; P<0.001). In comparisons of patient pairs, those in the valve-replacement group had more wins than the control group with respect to death from any cause (14.8% vs. 12.5%), postindex tricuspid-valve intervention (3.2% vs. 0.6%), and improvement in the KCCQ-OS score (23.1% vs. 6.0%), NYHA class (10.2% vs. 0.8%), and 6-minute walk distance (1.1% vs. 0.9%). The valve-replacement group had fewer wins than the control group with respect to the annualized rate of hospitalization for heart failure (9.7% vs. 10.0%). Severe bleeding occurred in 15.4% of the valve-replacement group and in 5.3% of the control group (P = 0.003); new permanent pacemakers were implanted in 17.4% and 2.3%, respectively (P<0.001)., Conclusions: For patients with severe tricuspid regurgitation, transcatheter tricuspid-valve replacement was superior to medical therapy alone for the primary composite outcome, driven primarily by improvements in symptoms and quality of life. (Funded by Edwards Lifesciences; TRISCEND II ClinicalTrials.gov number, NCT04482062.)., (Copyright © 2024 Massachusetts Medical Society.)
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- 2024
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40. Quality of Life After Transcatheter Tricuspid Valve Replacement: 1-Year Results From TRISCEND II Pivotal Trial.
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Arnold SV, Hahn RT, Thourani VH, Makkar R, Makar M, Sharma RP, Haeffele C, Davidson CJ, Narang A, O'Neill B, Lee J, Yadav P, Zahr F, Chadderdon S, Eleid M, Pislaru S, Smith R, Szerlip M, Whisenant B, Sekaran N, Garcia S, Stewart-Dehner T, Grayburn PA, Sannino A, Snyder C, Zhang Y, Mack MJ, Leon MB, Lurz P, Kodali S, and Cohen DJ
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Background: Severe tricuspid regurgitation (TR) often causes substantial impairment in patient-reported health status (ie, symptoms, physical and social function, and quality of life), which may improve with transcatheter tricuspid valve replacement (TTVR)., Objectives: We performed an in-depth analysis of health status of patients enrolled in the TRISCEND (Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device) II pivotal trial to help quantify the benefit of intervention to patients., Methods: The TRISCEND II pivotal trial randomized 400 patients with symptomatic and severe or greater TR 2:1 to TTVR with the EVOQUE tricuspid valve replacement system plus optimal medical therapy (OMT) or OMT alone. Health status was assessed with the Kansas City Cardiomyopathy Questionnaire and the 36-Item Short Form Health Survey. Changes in health status over 1 year were compared between treatment groups using mixed-effects repeated-measures models., Results: The analysis cohort included 392 patients, of whom 259 underwent attempted TTVR and 133 received OMT alone (mean age 79.2 ± 7.6 years, 75.5% women, 56.1% with massive or torrential TR). Patients had substantially impaired health status at baseline (mean Kansas City Cardiomyopathy Questionnaire Overall Summary Score [KCCQ-OS] 52.1 ± 22.8; mean 36-Item Short Form Health Survey physical component summary score 35.2 ± 8.4). TTVR+OMT patients reported significantly greater improvement in both disease-specific and generic health status at each follow-up time point. Mean between-group differences in the KCCQ-OS favored TTVR+OMT at each time point: 11.8 points (95% CI: 7.4-16.3 points) at 30 days, 20.8 points (95% CI: 16.1-25.5 points) at 6 months, and 17.8 points (95% CI: 13.0-22.5 points) at 1 year. In subgroup analyses, TTVR+OMT improved health status to a greater extent among patients with torrential or massive TR vs severe TR (treatment effect 23.3 vs 22.6 vs 11.3; interaction P = 0.049). At 1 year, 64.6% of TTVR+OMT patients were alive and well (KCCQ-OS ≥60 points and no decline of ≥10 points from baseline) compared with 31.0% with OMT alone., Conclusions: Compared with OMT alone, treatment of patients with symptomatic and severe or greater TR with TTVR+OMT resulted in substantial improvement in patients' symptoms, function, and quality of life. These benefits were evident 30 days after TTVR, continued to increase through 6 months, and remained durable through 1 year. (TRISCEND II Pivotal Trial [Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device]; NCT04482062)., Competing Interests: Funding Support and Author Disclosures The TRISCEND II pivotal trial and this analysis were funded by Edwards Lifesciences. Analyses were designed and conducted independently by the academic investigators. Dr Arnold has received research grants from the U.S. Food and Drug Administration and National Institutes of Health/National Heart, Lung, and Blood Institute. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, Philips Healthcare, and Siemens Healthineers; has held institutional consulting contracts with no direct compensation with Abbott Structural, Anteris, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; and has served as the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry sponsored valve trials with no direct industry compensation. Dr Thourani has received research/advisor fees from Abbott Vascular, Artivion, CroíValve, Boston Scientific, and Edwards Lifesciences; has received research grants from Medtronic, Highlife, Innovalve, JenaValve, and HalfMoon; and owns equity in Dasi Simulation. Dr Makkar has received research grants from Edwards Lifesciences, Abbott Vascular, Boston Scientific, JenaValve, and Medtronic; and has received travel support from Edwards Lifesciences, JenaValve, Abbott Vascular, and Boston Scientific. Dr Makar has received consulting fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, GE Healthcare, and PiCardia. Dr Sharma has received consulting fees from Edwards Lifesciences. Dr Haeffele has received consulting fees from Edwards Lifesciences and Shifamed. Dr Davidson has served as an uncompensated advisor for and received research grant support from Edwards Lifesciences. Dr Narang has received speaker fees from Edwards Lifesciences, Abbott Laboratories, and Bristol Myers Squibb. Dr O’Neill has received consulting fees from Edwards Lifesciences. Dr Lee has received consulting fees from Edwards Lifesciences. Dr Yadav has received consulting and speaker fees from Edwards Lifesciences, Abbott Vascular, and Boston Scientific; has received advisory board honoraria from Dasi Simulations and Trisol; and owns equity in Dasi Simulations and Opus. Dr Zahr has received consulting fees, research grants, and educational grants from Edwards Lifesciences and Medtronic. Dr Chadderdon has received consulting fees from Edwards Lifesciences and Medtronic; and has received research funding from GE Healthcare and Siemens Healthineers. Dr Smith has received research grants from Edwards Lifesciences, Medtronic, and Artivion, which are managed through the Baylor Scott & White research institute; has received speaker fees from Edwards Lifesciences and Medtronic; and has received advisory board honoraria from Edwards Lifesciences and Enable CV. Dr Szerlip has received consulting fees from Edwards Lifesciences; has received speaker fees from Edwards Lifesciences, Cardiovascular Innovations, the Society for Cardiovascular Angiography and Interventions, and Boston Scientific; and has received advisory board honoraria from Abbott Vascular. Dr Whisenant has received consulting fees from Edwards Lifesciences and Abbott Vascular. Dr Garcia has received consulting and proctor fees from Edwards Lifesciences, Medtronic, Abbott Structural Heart, JC Medical, and Boston Scientific. Dr Grayburn has received research grants from Abbott Vascular, CardioValve, Cardiomech, Edwards Lifesciences, Medtronic, NeoChord, Restore Medical, and 4C Medical; and has received advisory board honoraria from Abbott Vascular, CardioValve, Edwards Lifesciences, Medtronic, and 4C Medical. Dr Sannino has received research grants from Edwards Lifesciences and Venus Medtech. Dr Mack has received consulting fees and research grants from Edwards Lifesciences. Dr Lurz has received institutional fees and research grants from Abbott Vascular, Edwards Lifesciences, and ReCor; has received honoraria from Edwards Lifesciences, Abbott Medical, Innoventric, ReCor, and Boehringer Ingelheim; and owns stock options in Innoventric. Dr Kodali has received consulting fees from Anteris, TriCares, X-Dot, MicroInterventional Devices, Supira, Adona, Tioga, Helix Valve Repair, Moray Medical, and Nyra; has received advisory board honoraria from Dura Biotech, Thubrikar Aortic Valve, Philips, Medtronic, Boston Scientific, and Abbott; and has received institutional research funding from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. Dr Cohen has received research grants from the U.S. Food and Drug Administration, National Institutes of Health/National Heart, Lung, and Blood Institute, Edwards Lifesciences, Abbott, Boston Scientific, Medtronic, Philips, Corvia, Zoll Medical, and iRhythm; and has received consulting income from Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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41. Trends in Transcatheter Aortic Valve Replacement Outcomes: Insights From the STS/ACC TVT Registry.
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Arnold SV, Manandhar P, Vemulapalli S, Kosinski AS, Batchelor WB, Thourani VH, Mack MJ, and Cohen DJ
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Importance: Although transcatheter aortic valve replacement (TAVR) outcomes in the US have improved substantially since 2011, it is unknown whether these trends have continued since 2019., Objective: To examine changes in risk-adjusted TAVR outcomes from 2019 to 2022 and to examine any noteworthy trends over time., Design, Setting, and Participants: This cohort study examined data from patients with severe aortic stenosis treated with TAVR at 786 US hospitals between January 1, 2019, and March 31, 2022, included in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies (TVT) Registry., Exposure: Patients who underwent TAVR., Main Outcomes and Measures: The primary outcome was 30-day mortality, and the secondary outcomes were in-hospital mortality and 30-day composite adverse events. To understand factors explaining these trends, a series of logistic regression models was constructed for each outcome, with time as the primary explanatory variable. After adjusting for changing patent characteristics and procedural factors, a series of exploratory analyses was performed to examine the extent to which these findings could be explained by several plausible hypotheses., Results: This study's analytic cohort included a total of 210 495 patients. Median (IQR) patient age was 79 (73-85) years, and 91 313 patients (43.4%) were female. Median (IQR) STS predicted risk of mortality (PROM) was 3.3% (2.0%-5.3%). There were no significant changes in unadjusted 30-day mortality from quarter 1 of 2019 (2.4%) to the end of quarter 1 of 2022 (2.2%) (P for trend = .10), with an unadjusted odds ratio (OR) for time of 0.98 per year (95% CI, 0.94-1.01). After adjusting for patient characteristics, the OR increased to 1.05 per year (95% CI, 1.02-1.08), which increased further after adjusting for procedural characteristics to 1.09 per year (95% CI, 1.05-1.13). In exploratory analyses, there were no meaningful changes in the adjusted odds of death after excluding sites that entered the STS/ACC TVT Registry in 2019 or later (OR, 1.09; 95% CI, 1.05-1.13), low-volume sites (OR, 1.09; 95% CI, 1.06-1.13), low-risk patients (OR, 1.11; 95% CI, 1.07-1.15), patients with a bicuspid aortic valve (OR, 1.09; 95% CI, 1.05-1.13), in-hospital deaths (OR, 1.08; 95% CI, 1.03-1.14), or patients who experienced a major vascular complication (OR, 1.09; 95% CI, 1.05-1.12)., Conclusions and Relevance: In this observational cohort study performing a national analysis of outcomes after TAVR, it was found that risk-adjusted 30-day mortality increased modestly from January 2019 to March 2022. However, no site-level, patient-related, or process-related factors were identified that could explain these findings. Although the absolute increase in risk-adjusted mortality during the study period was relatively small, these findings warrant continued surveillance.
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- 2024
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42. Risk of Transfusion in Isolated Coronary Artery Bypass Graft: Models Developed From The Society of Thoracic Surgeons Database.
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Edgerton JR, Filardo G, Pollock BD, da Graca B, Ogola GO, DiMaio JM, and Mack MJ
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- Humans, Male, Female, Risk Assessment, Aged, Middle Aged, Thoracic Surgery, Retrospective Studies, United States epidemiology, Coronary Artery Disease surgery, Coronary Artery Bypass adverse effects, Blood Transfusion statistics & numerical data, Databases, Factual, Societies, Medical
- Abstract
Background: Perioperative blood transfusion is associated with adverse outcomes and higher costs after coronary artery bypass graft (CABG) surgery. We developed risk assessments for patients' probability of perioperative transfusion and the expected transfusion volume to improve clinical management and resource use., Methods: Among 1,266,545 consecutive (2008-2016) isolated CABG operations in The Society of Thoracic Surgeons Adult Cardiac Surgery Database, 657,821 (51.9%) received perioperative transfusions of red blood cells (RBC), fresh frozen plasma (FFP), cryoprecipitate, and/or platelets. We developed "full" models to predict perioperative transfusion of any blood product, and of RBC, FFP, or platelets. Using least absolute shrinkage and selection operator model selection, we built a rapid risk score based on 5 variables (age, body surface area, sex, preoperative hematocrit, and use of intra-aortic balloon pump)., Results: C statistics for the full model were 0.785, 0.815, 0.707, and 0.699 for any blood product, RBC, FFP, and platelets, respectively. C statistics for rapid risk assessments were 0.752, 0.785, 0.670, and 0.661 for any blood product, RBC, FFP, and platelets, respectively. The observed vs expected risk plots showed strong calibration for full models and risk assessment tools; absolute differences between observed and expected risks of transfusion were <10.8% in each percentile of expected risk. Risk assessment-predicted probabilities of transfusion were strongly and nonlinearly associated (P < .0001) with total units transfused., Conclusions: These robust and well-calibrated risk assessment tools for perioperative transfusion in CABG can inform surgeons regarding patients' risks and the number of RBC, FFP, and platelets units they can expect to need. This can aid in optimizing outcomes and increasing efficient use of blood products., Competing Interests: Disclosures The authors have no conflicts of interest to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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43. Health Care Resource Utilization Following Acute Myocardial Infarction: Findings from the RECORD-MI Registry.
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Talha KM, Hammonds K, Alhamdow A, Bennett MM, Bomar JVA, Ettlinger JA, Martinez-Traba M, Hartgers-Gubbels ES, Priest EL, Shaver CN, Afzal A, Widmer RJ, Gottlieb RL, Mack MJ, and Butler J
- Abstract
The contemporary health care resource utilization after an acute myocardial infarction (MI) is not well-known. All patients admitted because of MI between January 2015 and December 2021 across 28 hospitals in the Baylor Scott & White Health system were studied. Patient characteristics and outcomes, including all-cause and cardiovascular (CV) rehospitalizations, emergency department (ED) visits, and outpatient visits were evaluated. Of 6,804 patients admitted because of MI, 6,556 were discharged alive. The median age was 69 years, 60% were men, and 77% had non-ST-elevation MI; 17% (1,090) had multivessel disease. The number of patients with first all-cause readmissions within 30 days, 3 months, and 12 months of discharge were 844 (13%), 1,372 (21%), and 2,306 (35%), respectively, with a higher readmission rate in patients with non-ST-elevation MI, previous heart failure (HF), new-onset HF, and left ventricular ejection fraction ≤40%. ED visits at 12 months for any cause were 2,401 (37%), of which 1,321 (55%) were for any CV cause, with a higher incidence in patients with previous HF. Of the 6,556 patients, 4,102 (63%) had at least 1 primary care visit in the past year, 5,009 (76%) had CV specialty visits, and 3,860 (59%) had non-CV visits, with a similar distribution across subgroups. Patients hospitalized with an MI had a high risk of subsequent hospital readmissions and ED and outpatient visits, especially those with a previous HF diagnosis and those discharged with an MI and HF diagnosis., Competing Interests: Declaration of competing interest Dr. Butler reports financial support was provided by Boehringer Ingelheim & Eli Lilly and Company Diabetes Alliance. Dr. Afzal reports a relationship with AstraZeneca that includes: speaking and lecture fees. Dr. Alhamdow reports a relationship with Boehringer Ingelheim GmbH that includes: employment. Dr. Hartgers-Gubbels reports a relationship with Boehringer Ingelheim GmbH that includes: employment. Dr. Martinez-Traba reports a relationship with Boehringer Ingelheim GmbH that includes: employment. Dr. Butler reports a relationship with Abbott that includes: consulting or advisory. Dr. Butler reports a relationship with American Regent Inc that includes: consulting or advisory. Dr. Butler reports a relationship with Amgen Inc that includes: consulting or advisory. Dr. Butler reports a relationship with Applied Therapeutics Inc that includes: consulting or advisory. Dr. Butler reports a relationship with AskBio that includes: consulting or advisory. Dr. Butler reports a relationship with Astellas that includes: consulting or advisory. Dr. Butler reports a relationship with AstraZeneca that includes: consulting or advisory and speaking and lecture fees. Dr. Butler reports a relationship with Bayer that includes: consulting or advisory. Dr. Butler reports a relationship with Boehringer Ingelheim that includes: consulting or advisory and speaking and lecture fees. Dr. Butler reports a relationship with Boston Scientific Corporation that includes: consulting or advisory. Dr. Butler reports a relationship with Bristol Myers Squibb Co that includes: consulting or advisory. Dr. Butler reports a relationship with Cardiac Dimensions Inc that includes: consulting or advisory. Dr. Butler reports a relationship with Cardiocell that includes: consulting or advisory. Dr. Butler reports a relationship with Cardior that includes: consulting or advisory. Dr. Butler reports a relationship with Cardiorem that includes: consulting or advisory. Dr. Butler reports a relationship with CSL Behring that includes: consulting or advisory. Dr. Butler reports a relationship with CVRx Inc that includes: consulting or advisory. Dr. Butler reports a relationship with Cytokinetics Inc that includes: consulting or advisory. Dr. Butler reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Dr. Butler reports a relationship with Daxor that includes: consulting or advisory. Dr. Butler reports a relationship with Element Science that includes: consulting or advisory. Dr. Butler reports a relationship with Faraday that includes: consulting or advisory. Dr. Butler reports a relationship with Foundry that includes: consulting or advisory. Dr. Butler reports a relationship with G3P that includes: consulting or advisory. Dr. Butler reports a relationship with Innolife that includes: consulting or advisory. Dr. Butler reports a relationship with Impulse Dynamics that includes: consulting or advisory and speaking and lecture fees. Dr. Butler reports a relationship with Imbria that includes: consulting or advisory. Dr. Butler reports a relationship with Inventiva that includes: consulting or advisory. Dr. Butler reports a relationship with Ionis that includes: consulting or advisory. Dr. Butler reports a relationship with Lexicon that includes: consulting or advisory. Dr. Butler reports a relationship with Eli Lilly and Company that includes: consulting or advisory and speaking and lecture fees. Dr. Butler reports a relationship with LivaNova that includes: consulting or advisory. Dr. Butler reports a relationship with Janssen that includes: consulting or advisory. Dr. Butler reports a relationship with Medtronics that includes: consulting or advisory. Dr. Butler reports a relationship with Merck & Co Inc that includes: consulting or advisory. Dr. Butler reports a relationship with Occlutech that includes: consulting or advisory. Dr. Butler reports a relationship with Owkin Inc that includes: consulting or advisory. Dr. Butler reports a relationship with Novartis that includes: consulting or advisory and speaking and lecture fees. Dr. Butler reports a relationship with Novo Nordisk Inc that includes: consulting or advisory. Dr. Butler reports a relationship with Pfizer that includes: consulting or advisory. Dr. Butler reports a relationship with Pharmacosmos that includes: consulting or advisory. Dr. Butler reports a relationship with PharmaIN that includes: consulting or advisory. Dr. Butler reports a relationship with Prolaio that includes: consulting or advisory. Dr. Butler reports a relationship with Regeneron that includes: consulting or advisory. Dr. Butler reports a relationship with Renibus Therapeutics, Inc. that includes: consulting or advisory. Dr. Butler reports a relationship with Roche that includes: consulting or advisory. Dr. Butler reports a relationship with Salamandra that includes: consulting or advisory. Dr. Butler reports a relationship with Sanofi that includes: consulting or advisory. Dr. Butler reports a relationship with SC Pharma that includes: consulting or advisory. Dr. Butler reports a relationship with Secretome that includes: consulting or advisory. Dr. Butler reports a relationship with Sequana that includes: consulting or advisory. Dr. Butler reports a relationship with SQ Innovation that includes: consulting or advisory. Dr. Butler reports a relationship with Tenex that includes: consulting or advisory. Dr. Butler reports a relationship with Tricog that includes: consulting or advisory. Dr. Butler reports a relationship with Ultromics that includes: consulting or advisory. Dr. Butler reports a relationship with Vifor that includes: consulting or advisory. Dr. Butler reports a relationship with ZOLL that includes: consulting or advisory. Dr. Gottlieb reports a relationship with Alnylam Pharmaceuticals Inc that includes: consulting or advisory, funding grants, and speaking and lecture fees. Dr. Gottlieb reports a relationship with AstraZeneca that includes: consulting or advisory and funding grants. Dr. Gottlieb reports a relationship with Eli Lilly and Company that includes: consulting or advisory and funding grants. Dr. Gottlieb reports a relationship with Pfizer that includes: funding grants and speaking and lecture fees. Dr. Gottlieb reports a relationship with Johnson & Johnson that includes: funding grants. Dr. Priest reports a relationship with AstraZeneca that includes: funding grants. Dr. Priest reports a relationship with Owkin Inc that includes: funding grants. The remaining authors have no competing interests to declare., (Copyright © 2024. Published by Elsevier Inc.)
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- 2024
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44. Left Atrial Improvement in Patients With Secondary Mitral Regurgitation and Heart Failure: The COAPT Trial.
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Pio SM, Medvedofsky D, Delgado V, Stassen J, Weissman NJ, Grayburn PA, Kar S, Lim DS, Redfors B, Snyder C, Zhou Z, Alu MC, Kapadia SR, Lindenfeld J, Abraham WT, Mack MJ, Asch FM, Stone GW, and Bax JJ
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- Humans, Male, Female, Aged, Treatment Outcome, Time Factors, Aged, 80 and over, Middle Aged, Risk Factors, Heart Atria physiopathology, Heart Atria diagnostic imaging, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation mortality, Mitral Valve Insufficiency physiopathology, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency mortality, Mitral Valve Insufficiency surgery, Mitral Valve Insufficiency etiology, Heart Failure physiopathology, Heart Failure therapy, Heart Failure mortality, Heart Failure diagnostic imaging, Atrial Function, Left, Mitral Valve physiopathology, Mitral Valve diagnostic imaging, Mitral Valve surgery, Recovery of Function, Cardiac Catheterization adverse effects, Cardiac Catheterization instrumentation
- Abstract
Background: Functional mitral regurgitation induces adverse effects on the left ventricle and the left atrium. Left atrial (LA) dilatation and reduced LA strain are associated with poor outcomes in heart failure (HF). Transcatheter edge-to-edge repair (TEER) of the mitral valve reduces heart failure hospitalization (HFH) and all-cause death in selected HF patients., Objectives: The aim of this study was to evaluate the impact of LA strain improvement 6 months after TEER on the outcomes of patients enrolled in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial., Methods: The difference in LA strain between baseline and the 6-month follow-up was calculated. Patients with at least a 15% improvement in LA strain were labeled as "LA strain improvers." All-cause death and HFH were assessed between the 6- and 24-month follow-up., Results: Among 347 patients (mean age 71 ± 12 years, 63% male), 106 (30.5%) showed improvement of LA strain at the 6-month follow-up (64 [60.4%] from the TEER + guideline-directed medical therapy [GDMT] group and 42 [39.6%] from the GDMT alone group). An improvement in LA strain was significantly associated with a reduction in the composite of death or HFH between the 6-month and 24-month follow-up, with a similar risk reduction in both treatment arms (P
interaction = 0.27). In multivariable analyses, LA strain improvement remained independently associated with a lower risk of the primary composite endpoint both as a continuous variable (adjusted HR: 0.94 [95% CI: 0.89-1.00]; P = 0.03) and as a dichotomous variable (adjusted HR: 0.49 [95% CI: 0.27-0.89]; P = 0.02). The best outcomes were observed in patients treated with TEER in whom LA strain improved., Conclusions: In symptomatic HF patients with severe mitral regurgitation, improved LA strain at the 6-month follow-up is associated with subsequently lower rates of the composite endpoint of all-cause mortality or HFH, both after TEER and GDMT alone. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [COAPT]; NCT01626079)., Competing Interests: Funding Support and Author Disclosures The COAPT trial was sponsored by Abbott. Dr Delgado received speaker fees from Abbott Vascular, Edwards Lifesciences, Merck Sharp and Dohme, and GE Healthcare. Dr Stassen has received funding from the European Society of Cardiology (European Society of Cardiology Training Grant App000064741). Dr Weissman is associate director of an academic echocardiography core laboratory (MedStar Health Research Institute) with institutional contracts with Abbott, Neovasc, Ancora, Mitralign, Medtronic, Boston Scientific, Edwards Lifesciences, Biotronik, and Livanova. Dr Grayburn has received grant support from Abbott Vascular, Medtronic, Boston Scientific, Cardiovalve, Edwards Lifesciences, W. L. Gore, Medtronic, and NeoChord; and has received consulting fees from Abbott Vascular, Edwards Lifesciences, W. L. Gore, and 4C Medical. Dr Kar has received consulting fees and is an Advisory Board member at Boston Scientific; has received consulting fees and stock equity from Valcare; and has received consulting fees from W.L. Gore and Medtronic. Dr Lim has received research grant support from Abbott, Boston Scientific, Edwards, and Medtronic; has received consultant fees from LagonaTech, Valgen, and Venus; and is an Advisory Board member for Ancora and Philips. Dr Lindenfeld has received research grant support from AstraZeneca; and has received consulting fees from Abbott Vascular, CVRx, Edwards Lifesciences, RESMED, Relypsa, Boehringer Ingelheim, and V-Wave. Dr Abraham has received research grant support from the National Heart, Lung, and Blood Institute (National Institutes of Health 1 UG3/UH3 HL140144-01, 08/01/18-07/31/22, “Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Readmission/Mortality in Patients with Heart Failure and Central Sleep Apnea [LOFT-HF]”); has received consulting income from Abbott Vascular, Boehringer-Ingelheim, and Zoll Respicardia; has received speaker honoraria from Impulse Dynamics; and has received salary support from V-Wave Medical. Dr Mack has served as coprimary investigator for the PARTNER Trial for Edwards Lifesciences and COAPT trial for Abbott; and has served as study chair for the APOLLO trial for Medtronic. Dr Asch is the Director of the Core Laboratories at MedStar Health Research Institute, which has institutional contracts (no personal compensation) with Abbott, Neovasc, Ancora, Mitralign, Medtronic, Boston Scientific, Edwards Lifesciences, Biotronik, and Livanova. 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, Cardiomech, Gore, Amgen, Adona Medical, and Millennia Biopharma; and has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter. Dr Stone’s daughter is an employee at Medtronic; and Dr Stone’s employer, Mount Sinai Hospital, has received research support from Abbott, Abiomed, Bioventrix, Cardiovascular Systems Inc, Phillips, Biosense-Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-wave. Dr Bax has received speaker fees from Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
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45. Structural Cardiac Interventions in Patients With Heart Failure: JACC Scientific Statement.
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Hahn RT, Lindenfeld J, Lim SD, Mack MJ, and Burkhoff D
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- Humans, Heart Valve Diseases surgery, Heart Valve Diseases therapy, Cardiac Surgical Procedures methods, Cardiomyopathy, Dilated therapy, Cardiomyopathy, Dilated physiopathology, Heart Failure therapy
- Abstract
Pathologic left ventricular remodeling and valvular heart disease may contribute to the clinical presentation and outcomes of patients presenting with heart failure, and limit the effectiveness of guideline-directed medical therapy. Although surgical interventions including surgical ventricular restoration techniques and valve repair or replacement are effective therapies, there is growing evidence that transcatheter interventions may be options for patients with persistent symptoms of heart failure despite optimal medical therapy, where surgical options may be limited. This scientific statement will review the current available and investigational percutaneous strategies for the management of structural contributors to heart failure: dilated left ventricular cardiomyopathies and valvular heart disease., Competing Interests: Funding Support and Author Disclosures Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, Philips Healthcare, and Siemens Healthineers; and has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Edwards Lifesciences, Medtronic and Novartis. Dr Lindenfeld has received consulting fees from Abbott Structural, Axon, Alleviant, AstraZeneca, Boston Scientific, CVRx, Edwards Lifesciences, Merck, Medtronic, VWave, Vascular Dynamics, and Whiteswell; and has received research grants from AstraZeneca, Volumetrix, and Sensible Medical. Dr Lim has received consultant fees for Philips, Venus, and Valgen; and has received research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Mack has served as the coprincipal investigator or study chair for clinical trials sponsored by Abbott, Edwards Lifesciences, and Medtronic. Dr Burkhoff has received institutional support from Abiomed, Alleviant, Axon Therapies, Edwards Lifesciences, and Fire1; and has received consulting fees from Aquapass, Axon Therapies, BackBeat Medical, Corvia, BioMind, Impulse Dynamics, and Therox/Zoll., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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46. Left and right ventricular longitudinal systolic function following aortic valve replacement in the PARTNER 2 trial and registry.
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Silva I, Ternacle J, Hahn RT, Salah-Annabi M, Dahou A, Krapf L, Salaun E, Guzzetti E, Xu K, Clavel MA, Bernier M, Beaudoin J, Cremer PC, Jaber W, Rodriguez L, Asch FM, Weismann NJ, Bax J, Ajmone N, Alu MC, Kallel F, Mack MJ, Webb JG, Kapadia S, Makkar R, Kodali S, Herrmann HC, Thourani V, Leon MB, and Pibarot P
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- Humans, Male, Female, Aged, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement methods, Risk Assessment, Systole, Aged, 80 and over, Treatment Outcome, Stroke Volume physiology, Echocardiography, Ventricular Dysfunction, Left diagnostic imaging, Ventricular Dysfunction, Left physiopathology, Registries, Aortic Valve Stenosis surgery, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis physiopathology, Heart Valve Prosthesis Implantation methods, Heart Valve Prosthesis Implantation adverse effects
- Abstract
Aims: Evaluation of left and right ventricular (RV) longitudinal systolic function may enhance risk stratification following aortic valve replacement (AVR). The study objective was to evaluate the changes in left and RV longitudinal systolic function and RV-pulmonary artery (RV-PA) coupling from baseline to 30 days and 1 year after AVR., Methods and Results: Left ventricular (LV) longitudinal strain (LS), tricuspid annulus plane systolic excursion (TAPSE), and RV-PA coupling were evaluated in patients from the PARTNER 2A surgical AVR (SAVR) arm (n = 985) and from the PARTNER 2 SAPIEN 3 registry (n = 719). TAPSE and RV-PA coupling decreased significantly following SAVR, but remained stable following TAVR. Lower LV LS, TAPSE, or RV-PA coupling at baseline was associated with increased risk of the composite of death, hospitalization, and stroke at 5 years [adjusted hazard ratios (HRs) for LV LS < 15%: 1.24, 95% confidence interval (CI) 1.05-1.45, P = 0.001; TAPSE < 14 mm: 1.44, 95% CI 1.21-1.73, P < 0.001; RV-PA coupling < 0.55 mm/mmHg: 1.32, 95% CI 1.07-1.63, P = 0.011]. Reduced TAPSE at baseline was the most powerful predictor of the composite endpoint at 5 years. Patients with LV ejection fraction <50% at baseline had increased risk of the primary endpoint with SAVR (HR: 1.34, 95% CI 1.08-1.68, P = 0.009) but not with TAVR (HR: 1.12, 95% CI 0.88-1.42). Lower RV-PA coupling at 30 days showed the strongest association with cardiac mortality., Conclusion: SAVR but not TAVR was associated with a marked deterioration in RV longitudinal systolic function and RV-PA coupling. Lower TAPSE and RV-PA coupling at 30 days were associated with inferior clinical outcomes at 5 years. In patients with LVEF < 50%, TAVR was associated with superior 5-year outcomes., Competing Interests: Conflict of interest: J.T. is consultant for Abbott, Philips Healthcare, and General Electric. R.T.H. reports speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, and Philips Healthcare; she has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Edwards Lifesciences, Medtronic, and Novartis; she is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored tricuspid valve trials, for which she receives no direct industry compensation. M.-A.C. has research grant with Medtronic and core laboratory contract with Edwards Lifesciences without direct compensation. W.J. is consultant for Boston Scientific and BridgeBio. F.M.A. and N.J.W. have institutional research grants as directors of an academic core lab from Edwards, Abbott, Medtronic, Boston Scientific, Biotronik, Corcyn, and Foldax. They have no personal disclosures. N.A. received speakers fees from Abbott Vascular, GE Healthcare, and Philips ultrasound and research grants from Alnylam and Pfizer. H.C.H. reports institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, Highlife, Medtronic, and WL Gore; consulting fees from Edwards Lifesciences, Medtronic, Wells Fargo, and WL Gore; and equity in Holistick Medical and Micro Interventional Devices. M.J.M. has served as a Co-Pi for clinical trials for Abbott and Edwards Lifesciences and as Study Chair for a trial for Medtronic. All roles were uncompensated. V.T. is consultant or researcher for Abbott Vascular, Boston Scientific, CryoLife, Edwards Lifesciences, Medtronic, and Shockwave. The other authors have nothing to disclose., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)
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- 2024
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47. TRISCEND II: Novel Randomized Trial Design for Transcatheter Tricuspid Valve Replacement.
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Grayburn PA, Kodali SK, Hahn RT, Lurz P, Thourani VH, Kozorovitsky ER, Gilmore SY, Vinekar C, Zhang B, Boulware K, Krzmarzick AM, Nguyen D, Vu MT, Feldman T, Mack MJ, and Leon MB
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- Humans, Prospective Studies, Heart Valve Prosthesis, Treatment Outcome, Tricuspid Valve Insufficiency surgery, Heart Valve Prosthesis Implantation methods, Cardiac Catheterization methods, Tricuspid Valve surgery
- Abstract
Severe tricuspid regurgitation remains largely undertreated given limited treatment options. Transcatheter tricuspid valve interventions have emerged as a promising therapy for these patients, and the TRISCEND II pivotal trial is the first randomized controlled trial to evaluate transcatheter tricuspid valve replacement (TTVR). The TRISCEND II pivotal trial studies the transcatheter EVOQUE (Edwards Lifesciences, Irvine, California) tricuspid valve replacement system using a United States Food and Drug Administration Breakthrough Device Designation-a program intended to provide timely access to medical devices by speeding up development, assessment, and review. The TRISCEND II trial is a prospective, multicenter trial that randomizes patients with symptomatic severe tricuspid regurgitation to treatment with either TTVR in conjunction with optimal medical therapy or optimal medical therapy alone. The trial's novel 2-phase design evaluates 30-day safety and 6-month effectiveness end points for the first 150 patients in the initial phase and a 1-year safety and effectiveness end point for the full cohort of 400 patients in the second phase. The TRISCEND II trial's 2-phase trial design provided an opportunity for early review and led to the first commercial approval of a TTVR system. In conclusion, the design of the TRISCEND II trial will likely inform future transcatheter tricuspid device trials., Competing Interests: Declaration of competing interest Dr. Grayburn receives grant support from Abbott Vascular, CardioMech, Cardiovalve, Edwards Lifesciences, Medtronic, Neochord, Restore Medical, and 4C Medical and Advisory Board/Consultant fees from Abbott Vascular, Edwards Lifesciences, Medtronic, and 4C Medical. Dr. Kodali reports institutional research grants from Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, and JenaValve; and is a consultant to Admedus, TriCares, TriFlo, X-Dot, MicroInterventional Devices, Supira, Adona, Tioga, Helix Valve Repair, and moray Medical and serves on advisory boards for Dura Biotech, Thubrikar Aortic Valve Inc., Phillips, Medtronic, and Boston Scientific. Dr. Hahn reports speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Edwards Lifesciences, Medtronic, and Novartis; and is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored tricuspid valve trials, for which she receives no direct industry compensation. Dr. Lurz has received institutional fees and research grants from Abbott Vascular, Edwards Lifesciences, and ReCor, honoraria from Edwards Lifesciences, Abbott Medical, Innoventric, ReCor, and Boehringer Ingelheim, and has stock options with Innoventric. Dr. Thourani is an advisor or researcher for Artivion, AtriCure, Abbott Vascular, Boston Scientific, Edwards Lifesciences, JenaValve, and Shockwave. Dr. Mack reports consulting fees and research grants from Edwards Lifesciences. Dr. Leon reports institutional clinical research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Efraim Kozorovitsky, Suzanne Gilmore, Chandan Vinekar, Bonnie Zhang, Kristin Boulware, Ann Krzmarzick, Don Nguyen, Minh Vu, and Dr Feldman are employed by Edwards Lifesciences., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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48. One-Year Outcomes of Transseptal Mitral Valve-in-Valve in Intermediate Surgical Risk Patients.
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Malaisrie SC, Guerrero M, Davidson C, Williams M, de Brito FS Jr, Abizaid A, Shah P, Kaneko T, Poon K, Levisay J, Yu X, Pibarot P, Hahn RT, Blanke P, Leon MB, Mack MJ, and Zajarias A
- Subjects
- Humans, Female, Male, Aged, Prospective Studies, Time Factors, Treatment Outcome, Risk Factors, Middle Aged, Risk Assessment, Aged, 80 and over, United States, Mitral Valve Stenosis surgery, Mitral Valve Stenosis physiopathology, Mitral Valve Stenosis mortality, Mitral Valve Stenosis diagnostic imaging, Hemodynamics, Stroke etiology, Stroke mortality, Mitral Valve surgery, Mitral Valve physiopathology, Mitral Valve diagnostic imaging, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation mortality, Bioprosthesis, Cardiac Catheterization instrumentation, Cardiac Catheterization adverse effects, Cardiac Catheterization mortality, Mitral Valve Insufficiency surgery, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency physiopathology, Mitral Valve Insufficiency mortality, Prosthesis Design, Prosthesis Failure, Recovery of Function
- Abstract
Background: Transcatheter mitral valve-in-valve replacement offers a less-invasive alternative for high-risk patients with bioprosthetic valve failure. Limited experience exists in intermediate-risk patients. We aim to evaluate 1-year outcomes of the PARTNER 3 mitral valve-in-valve study., Methods: This prospective, single-arm, multicenter study enrolled symptomatic patients with a failing mitral bioprosthesis demonstrating greater than or equal to moderate stenosis and regurgitation and Society of Thoracic Surgeons score ≥3% and <8%. A balloon-expandable transcatheter heart valve (SAPIEN 3, Edwards Lifesciences) was used via a transeptal approach. The primary end point was the composite of all-cause mortality and stroke at 1 year., Results: A total of 50 patients from 12 sites underwent mitral valve-in-valve from 2018 to 2021. The mean age was 70.1±9.7 years, mean Society of Thoracic Surgeons score was 4.1%±1.6%, and 54% were female. There were no primary end point events (mortality or stroke) through 1 year, and no left-ventricular outflow tract obstruction, endocarditis, or mitral valve reintervention was reported. Six patients (12%) required rehospitalization, including heart failure (n=2), minor procedural side effects (n=2), and valve thrombosis (n=2; both resolved with anticoagulation). An additional valve thrombosis was associated with no significant clinical sequelae. From baseline to 1 year, all subjects with available data had none/trace or mild (grade 1+) mitral regurgitation and the New York Heart Association class improved in 87.2% (41/47) of patients., Conclusions: Mitral valve-in-valve with a balloon-expandable valve via transseptal approach in intermediate-risk patients was associated with improved symptoms and quality of life, adequate transcatheter valve performance, and no mortality or stroke at 1-year follow-up., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03193801., Competing Interests: Dr Malaisrie reports institutional research grants from Edwards Lifesciences, Medtronic, and Terumo Medical Corporation and consulting/speaker fees from Edwards Lifesciences, Terumo Medical Corporation, and Artivion; Dr Guerrero reports institutional research grants from Edwards Lifesciences; Dr Davidson reports institutional research grants from Edwards Lifesciences and Abbott Vascular and consulting/speaker fees from Edwards Lifesciences; Dr Williams reports institutional research grants from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific and consulting/speaker fees from Medtronic; Dr de Brito is a proctor for Medtronic, Edwards Lifesciences, and Boston Scientific; Dr Shah reports institutional research grants from Edwards Lifesciences, Medtronic, and Abbott Vascular and consulting/speaker fees from Edwards Lifesciences; Dr Kaneko reports consulting/speaker fees from Edwards Lifesciences, Medtronic, and Abbott Vascular; Dr Poon reports institutional research grants from Edwards Lifesciences and consulting/speaker fees from Edwards Lifesciences and Anteris; Dr Yu is an employee of Edwards Lifesciences; Dr Pibarot reports institutional research grants from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Success; Dr Hahn reports speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, and Philips Healthcare; she has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Edwards Lifesciences, Medtronic and Novartis; she is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored tricuspid valve trials, for which she receives no direct industry compensation; Dr Blanke reports consulting/speaker fees from Edwards Lifesciences and LARALAB; Dr Leon reports institutional research grants from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular; Dr Mack has served as trial coprimary investigator for Edwards Lifesciences and Abbott Vascular and has served as a study chair for Medtronic; Dr Zajarias reports consulting/speaker fees from Edwards Lifesciences and Medtronic. The other authors report no conflicts.
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- 2024
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49. A Guide to Transcatheter Aortic Valve Design and Systematic Planning for a Redo-TAV (TAV-in-TAV) Procedure.
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Bapat VN, Fukui M, Zaid S, Okada A, Jilaihawi H, Rogers T, Khalique O, Cavalcante JL, Landes U, Sathananthan J, Tarantini G, Tang GHL, Blackman DJ, De Backer O, Mack MJ, and Leon MB
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- Humans, Treatment Outcome, Risk Factors, Clinical Decision-Making, Aortic Valve Stenosis surgery, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis physiopathology, Terminology as Topic, Predictive Value of Tests, Transcatheter Aortic Valve Replacement instrumentation, Transcatheter Aortic Valve Replacement adverse effects, Heart Valve Prosthesis, Prosthesis Design, Aortic Valve surgery, Aortic Valve diagnostic imaging, Aortic Valve physiopathology, Reoperation
- Abstract
Transcatheter aortic valve replacement (TAVR) has become more common than surgical aortic valve replacement since 2016, with over 200,000 procedures globally each year. As patients increasingly outlive their TAVR devices, managing these cases is a growing concern. Treatment options include surgical removal of the old TAVR device (transcatheter aortic valve [TAV] explant) or implantation of a new transcatheter aortic valve (redo TAV). Redo TAV is complex because of the unique designs of TAV devices; compatibility issues; and the need for individualized planning based on factors such as implant depth, shape, and coronary artery relationships. This review serves as a comprehensive guide for redo TAV, detailing the design characteristics of TAV devices, device compatibility, standardized terminology, and a structured approach for computed tomography analysis. It aims to facilitate decision making, risk identification, and achieving optimal outcomes in redo TAV procedures., Competing Interests: Funding Support and Author Disclosures Dr Bapat has served as a consultant for Medtronic, Edwards Lifesciences, Abbott, Anteris, Meril Lifesciences, and Boston Scientific. Dr Jilaihawi has received institutional research grants and consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic Inc; and has received institutional research grants from Boston Scientific and Pi-Cardia. Dr Rogers is a consultant for Edwards Lifesciences, Medtronic, Boston Scientific, and Transmural Systems; serves on advisory boards for Medtronic and Boston Scientific; holds an equity interest in Transmural Systems; and is a coinventor on patents, assigned to National Institutes of Health, for transcatheter electrosurgery devices. Dr Khalique is a consultant for Edwards Lifesciences, Restore Medical, Croivalve, Heartflow, and Vdyne; and holds equity in Triflo. Dr Cavalcante is a consultant for 3Mensio, 4C Medical, Abbott Structural, Anteris, Boston Scientific, Edwards Lifesciences, JenaValve, Medtronic, and Siemens Healthineers. Dr Landes has received consulting fees from Edwards Lifesciences. Dr Sathananthan has received speaker fees from Edwards Lifesciences, Medtronic, NVT Medical, and Boston Scientific; is a consultant for Edwards Lifesciences, Boston Scientific, Medtronic, and Anteris; and serves as chief medical officer for structural division of Boston Scientific. Dr Tarantini has received lecture fees from Medtronic, Edwards Lifesciences, Abbott, and Boston Scientifics. Dr Tang has received speaker honoraria and has served as a physician proctor, consultant, advisory board member, TAVR publications committee member, APOLLO trial screening committee member, and IMPACT MR steering committee member for Medtronic; has received speaker honoraria and has served as a physician proctor, consultant, advisory board member, and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific and JenaValve, a consultant and physician screening committee member for Shockwave Medical, a consultant for NeoChord, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Blackman is a consultant, proctor, and advisory board member for Medtronic and Abbott Vascular; and has received institutional research grants from Medtronic. Dr De Backer has received institutional research grants and consulting fees from Abbott and Boston Scientific. Dr Mack served as co–primary investigator for the PARTNER trial for Edwards Lifesciences and the COAPT trial for Abbott; and has served as study chair for the APOLLO trial for Medtronic. Dr Leon has received institutional grants for clinical research from Abbott, Boston Scientific, Edwards Lifesciences, JenaValve, and Medtronic; and has received stock options (equity) for advisory board participation in Valve Medical, Picardia, and Venus MedTech. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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50. Transcatheter heart valve explant with infective endocarditis-associated prosthesis failure and outcomes: the EXPLANT-TAVR international registry.
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Marin-Cuartas M, Tang GHL, Kiefer P, Fukuhara S, Lange R, Harrington KB, Saha S, Hagl C, Kleiman NS, Goel SS, Kempfert J, Werner P, Petrossian GA, Geirsson A, Desai ND, Chu MWA, Bhadra OD, Shults C, Garatti A, Vincent F, Grubb KJ, Goldberg JB, Mack MJ, Modine T, Denti P, Kaneko T, Bapat VN, Reardon MJ, Borger MA, and Zaid S
- Subjects
- Humans, Male, Female, Aged, Device Removal, Heart Valve Prosthesis adverse effects, Bioprosthesis adverse effects, Treatment Outcome, Aged, 80 and over, Postoperative Complications epidemiology, Postoperative Complications etiology, Registries, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement mortality, Prosthesis Failure, Prosthesis-Related Infections epidemiology, Prosthesis-Related Infections mortality, Endocarditis surgery, Endocarditis mortality
- Abstract
Background and Aims: Surgical explantation of transcatheter heart valves (THVs) is rapidly increasing, but there are limited data on patients with THV-associated infective endocarditis (IE). This study aims to assess the outcomes of patients undergoing THV explant for IE., Methods: All patients who underwent THV explant between 2011 and 2022 from 44 sites in the EXPLANT-TAVR registry were identified. Patients with IE as the reason for THV explant were compared to those with other mechanisms of bioprosthetic valve dysfunction (BVD)., Results: A total of 372 patients from the EXPLANT-TAVR registry were included. Among them, 184 (49.5%) patients underwent THV explant due to IE and 188 (50.5%) patients due to BVD. At the index transcatheter aortic valve replacement, patients undergoing THV explant for IE were older (74.3 ± 8.6 vs. 71 ± 10.6 years) and had a lower Society of Thoracic Surgeons risk score [2.6% (1.8-5.0) vs. 3.3% (2.1-5.6), P = .029] compared to patients with BVD. Compared to BVD, IE patients had longer intensive care unit and hospital stays (P < .05) and higher stroke rates at 30 days (8.6% vs. 2.9%, P = .032) and 1 year (16.2% vs. 5.2%, P = .010). Adjusted in-hospital, 30-day, and 1-year mortality was 12.1%, 16.1%, and 33.8%, respectively, for the entire cohort, with no significant differences between groups. Although mortality was numerically higher in IE patients 3 years postsurgery (29.6% for BVD vs. 43.9% for IE), Kaplan-Meier analysis showed no significant differences between groups (P = .16)., Conclusions: In the EXPLANT-TAVR registry, patients undergoing THV explant for IE had higher 30-day and 1-year stroke rates and longer intensive care unit and hospital stays. Moreover, patients undergoing THV explant for IE had a higher 3-year mortality rate, which did not reach statistical significance given the relatively small sample size of this unique cohort and the reduced number of events., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)
- Published
- 2024
- Full Text
- View/download PDF
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