113 results on '"Witberg G"'
Search Results
2. Acute ischemic stroke complicating tavi. predictors, outcomes, and treatment associated outcomes
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Kheifets, M, primary, Kruchin, B, additional, Aviram, I, additional, Vaknin-Assa, H, additional, Barnea, R, additional, Findler, M, additional, Perl, L, additional, Witberg, G, additional, Codner, P, additional, Talmor-Barkan, Y, additional, Rephaeli, G, additional, Uriel, E, additional, Kornowski, R, additional, and Levi, A, additional
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- 2023
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3. 5-year outcomes of patients with mitral structural valve deterioration treated with transcatheter valve in valve implantation
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Schamroth Pravda, N, primary, Mishaev, R, additional, Levi, A, additional, Witberg, G, additional, Shapira, Y, additional, Orvin, K, additional, Talmor Barkan, Y, additional, Hamdan, A, additional, Sharoni, R, additional, Perl, L, additional, Sagie, A, additional, Vaknin Assa, H, additional, Kornowski, R, additional, and Codner, P, additional
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- 2022
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4. Association of socioeconomic status measures with physical activity and subsequent frailty in older adults
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Kheifets, M, primary, Goshen, A, additional, Goldbourt, U, additional, Witberg, G, additional, Eisen, A, additional, Kornowski, R, additional, and Gerber, Y, additional
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- 2022
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5. Characteristics of aortic root and vascular anatomy in bicuspid versus tricuspid aortic valve anatomy
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Hamdan, A, primary, Witberg, G, additional, Perlman, G, additional, Aviv, Y, additional, Shiyovich, A, additional, Vaknin Assa, H, additional, Abid Assali, A, additional, Lessick, J, additional, Kerner, A, additional, Segev, A, additional, Barabash, I, additional, Goitein, O, additional, Brodov, Y, additional, Finkelstein, A, additional, and Kornowski, R, additional
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- 2021
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6. Venous thromboembolism prophylaxis with anticoagulation in septic patients: a prospective cohort study
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Zusman, O., Paul, M., Farbman, L., Daitch, V., Akayzen, Y., Witberg, G., Avni, T., Gafter-Gvili, A., and Leibovici, L.
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- 2015
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7. Transcatheter Replacement of Transcatheter Versus Surgically Implanted Aortic Valve Bioprostheses
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Landes, U, Sathananthan, J, Witberg, G, de Backer, O, Sondergaard, L, Abdel-Wahab, M, Holzhey, D, Kim, WK, Hamm, C, Buzzatti, N, Montorfano, M, Ludwig, S, Conradi, L, Seiffert, M, Guerrero, M, El Sabbagh, A, Rodés-Cabau, J, Guimaraes, L, Codner, P, Okuno, T, Pilgrim, T, Fiorina, C, Colombo, A, Mangieri, A, Eltchaninoff, H, Nombela-Franco, L, van Wiechen, Maarten, van Mieghem, Nicolas, Tchétché, D, Schoels, WH, Kullmer, M, Tamburino, C, Sinning, JM, Al-Kassou, B, Perlman, GY, Danenberg, H, Ielasi, A, Fraccaro, C, Tarantini, G, De Marco, F, Redwood, SR, Lisko, JC, Babaliaros, VC, Laine, M, Nerla, R, Castriota, F, Finkelstein, A, Loewenstein, I, Eitan, A, Jaffe, R, Ruile, P, Neumann, FJ, Piazza, N, Alosaimi, H, Sievert, H, Sievert, K, Russo, M, Andreas, M, Bunc, M, Latib, A, Godfrey, R, Hildick-Smith, D, Chuang, MYA, Blanke, P, Leipsic, J, Wood, DA, Nazif, T M, Kodali, S, Barbanti, M, Kornowski, R, Leon, MB, Webb, JG, Landes, U, Sathananthan, J, Witberg, G, de Backer, O, Sondergaard, L, Abdel-Wahab, M, Holzhey, D, Kim, WK, Hamm, C, Buzzatti, N, Montorfano, M, Ludwig, S, Conradi, L, Seiffert, M, Guerrero, M, El Sabbagh, A, Rodés-Cabau, J, Guimaraes, L, Codner, P, Okuno, T, Pilgrim, T, Fiorina, C, Colombo, A, Mangieri, A, Eltchaninoff, H, Nombela-Franco, L, van Wiechen, Maarten, van Mieghem, Nicolas, Tchétché, D, Schoels, WH, Kullmer, M, Tamburino, C, Sinning, JM, Al-Kassou, B, Perlman, GY, Danenberg, H, Ielasi, A, Fraccaro, C, Tarantini, G, De Marco, F, Redwood, SR, Lisko, JC, Babaliaros, VC, Laine, M, Nerla, R, Castriota, F, Finkelstein, A, Loewenstein, I, Eitan, A, Jaffe, R, Ruile, P, Neumann, FJ, Piazza, N, Alosaimi, H, Sievert, H, Sievert, K, Russo, M, Andreas, M, Bunc, M, Latib, A, Godfrey, R, Hildick-Smith, D, Chuang, MYA, Blanke, P, Leipsic, J, Wood, DA, Nazif, T M, Kodali, S, Barbanti, M, Kornowski, R, Leon, MB, and Webb, JG
- Abstract
Background: Surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) are now both used to treat aortic stenosis in patients in whom life expectancy may exceed valve durability. The choice of initial bioprosthesis should therefore consider the relative safety and efficacy of potential subsequent interventions. Objectives: The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs). Methods: Data were collected on 434 TAV-in-TAV and 624 TAV-in-SAV consecutive procedures performed at centers participating in the Redo-TAVR international registry. Propensity score matching was applied, and 330 matched (165:165) patients were analyzed. Principal endpoints were procedural success, procedural safety, and mortality at 30 days and 1 year. Results: For TAV-in-TAV versus TAV-in-SAV, procedural success was observed in 120 (72.7%) versus 103 (62.4%) patients (p = 0.045), driven by a numerically lower frequency of residual high valve gradient (p = 0.095), ectopic valve deployment (p = 0.081), coronary obstruction (p = 0.091), and conversion to open heart surgery (p = 0.082). Procedural safety was achieved in 116 (70.3%) versus 119 (72.1%) patients (p = 0.715). Mortality at 30 days was 5 (3%) after TAV-in-TAV and 7 (4.4%) after TAV-in-SAV (p = 0.570). At 1 year, mortality was 12 (11.9%) and 10 (10.2%), respectively (p = 0.633). Aortic valve area was larger (1.55 ± 0.5 cm2 vs. 1.37 ± 0.5 cm2; p = 0.040), and the mean residual gradient was lower (12.6 ± 5.2 mm Hg vs. 14.9 ± 5.2 mm Hg; p = 0.011) after TAV-in-TAV. The rate of moderate or greater residual aortic regurgitation was similar, but mild aortic regurgitation was more frequent after TAV-in-TAV (p = 0.003). Conclusions: In propensity score–matched cohorts of TAV-in-TAV versus TAV-in-SAV patients, TAV-in-TAV was associated with higher procedural success and similar procedural safety or mortality.
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- 2021
8. Transcatheter Treatment of Residual Significant Mitral Regurgitation Following TAVR: A Multicenter Registry
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Witberg, G, Codner, P, Landes, U, Brabanti, M, Valvo, R, De Backer, O, Ooms, JF, Sievert, K, El Sabbagh, A, Jimenez-Quevedo, P, Brennan, PF, Sedaghat, A, Masiero, G, Werner, P, Overtchouk, P, Watanabe, Y, Montorfano, M, Bijjam, VR, Hein, M, Fiorina, C, Arzamendi, D, Rodriguez-Gabella, T, Fernandez-Vazquez, F, Baz, JA, Laperche, C, Grasso, C, Branca, L, Estevez-Loureiro, R, Benito-Gonzalez, T, Santos, IJA, Ruile, P, Mylotte, D, Buzzatti, N, Piazza, N, Andreas, M, Tarantini, G, Sinning, JM, Spence, MS, Nombela-Franco, L, Guerrero, M, Sievert, H, Sondergaard, L, Van Mieghem, NM, Tchetche, D, Webb, JG, Kornowski, R, and Cardiology
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Aged, 80 and over ,Mitral Valve Insufficiency ,aortic stenosis ,Aortic Valve Stenosis ,TAVR ,Severity of Illness Index ,mitral regurgitation ,TMVR/r ,Transcatheter Aortic Valve Replacement ,Treatment Outcome ,Aortic Valve ,Humans ,Registries ,Aged - Abstract
OBJECTIVES The aim of this study was to describe baseline characteristics, and periprocedural and mid-term outcomes of patients undergoing transcatheter mitral valve interventions post-transcatheter aortic valve replacement (TAVR) and examine their clinical benefit. BACKGROUND The optimal management of residual mitral regurgitation (MR) post-TAVR is challenging. METHODS This was an international registry of 23 TAVR centers. RESULTS In total, 106 of 24,178 patients (0.43%) underwent mitral interventions post-TAVR (100 staged, 6 concomitant), most commonly percutaneous edge-to-edge mitral valve repair (PMVR). The median interval post-TAVR was 164 days. Mean age was 79.5 +/- 7.2 years, MR was >moderate in 97.2%, technical success was 99.1%, and 30-day device success rate was 88.7%. There were 18 periprocedural complications (16.9%) including 4 deaths. During a median follow-up of 464 days, the cumulative risk for 3-year mortality was 29.0%. MR grade and New York Heart Association (NYHA) functional class improved dramatically; at 1 year, MR was moderate or less in 90.9% of patients (mild or less in 69.1%), and 85.9% of patients were in NYHA functional class I/II. Staged PMVR was associated with lower mortality versus medical treatment (57.5% vs. 30.8%) in a propensity-matched cohort (n = 156), but this was not statistically significant (hazard ratio: 1.75; p = 0.05). CONCLUSIONS For patients who continue to have significant MR, remain symptomatic post-TAVR, and are anatomically suitable for transcatheter interventions, these interventions are feasible, safe, and associated with significant improvement in MR grade and NYHA functional class. These results apply mainly to PMVR. A staged PMVR strategy was associated with markedly lower mortality, but this was not statistically significant. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter Valve Registry [AMTRAC]; NCT04031274) (C) 2020 by the American College of Cardiology Foundation.
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- 2020
9. Residential exposure to greenness and mortality in a cardio-oncologic population
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Ashri, S, Cohen, G, Itzhaki Ben Zadok, O, Moran, M, Broday, D M, Steinberg, D M, Keinan-Boker, L, Witberg, G, Bental, T, Golan, L, Kornowski, R, and Gerber, Y
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- 2024
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10. P4640Validation of the PRECISE-DAPT Score in a real-world cohort of patients undergoing coronary stent implantation
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Witberg, G, primary, Zusman, O Z, additional, Bental, T, additional, Plakht, I, additional, Gabbay, H, additional, Gerber, Y, additional, and Kornowski, R, additional
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- 2019
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11. P4589The prognostic impact of the Medina classification in bifurcation lesion percutaneous coronary intervention
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Perl, L, primary, Witberg, G, additional, Vaknin-Assa, H, additional, Kornowski, R, additional, and Assali, A, additional
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- 2019
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12. Angiogram based fractional flow reserve in patients with dual/triple vessel coronary artery disease
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Omori, H., primary, Witberg, G., additional, Kawase, Y., additional, Tanigaki, T., additional, Okamoto, S., additional, Hirata, T., additional, Sobue, Y., additional, Ota, H., additional, Kamiya, H., additional, Okubo, M., additional, Valzer, O., additional, Kornowski, R., additional, and Matsuo, H., additional
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- 2019
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13. P6333Transcatheter aortic valve implantation futility risk model development and validation among treated aortic stenosis patients
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Zusman, O., primary, Landes, U., additional, Orvin, K., additional, Levi, A., additional, Witberg, G., additional, Assali, A., additional, Vaknin-Assa, H., additional, Sharony, R., additional, Hamdan, A., additional, Shapira, Y., additional, Sagie, A., additional, and Kornowski, R., additional
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- 2017
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14. Venous thromboembolism prophylaxis with anticoagulation in septic patients: a prospective cohort study
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Zusman, O., primary, Paul, M., additional, Farbman, L., additional, Daitch, V., additional, Akayzen, Y., additional, Witberg, G., additional, Avni, T., additional, Gafter-Gvili, A., additional, and Leibovici, L., additional
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- 2014
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15. Is 90 the new 80? Temporal trends in nonagenarians undergoing percutaneous coronary interventions.
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Rahat O, Kheifets M, Bental T, Abigail Vons S, Tishler O, Lerman TT, Kaufman C, Perl L, Greenberg G, Codner P, Witberg G, Vaknin-Assa H, Kornowski R, and Levi A
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- Humans, Aged, 80 and over, Female, Male, Age Factors, Percutaneous Coronary Intervention trends, Coronary Artery Disease surgery, Coronary Artery Disease epidemiology, Coronary Artery Disease mortality
- Abstract
Background: Coronary artery disease (CAD) is a leading cause of death in the elderly population. Data regarding percutaneous coronary interventions (PCIs) in nonagenarians are scarce, and differences in long term outcomes between generations remain unclear. We aimed to study the pattern and temporal trends of nonagenarians treated with PCI., Materials and Methods: A total of 14,695 patients underwent PCI between 2009-2020. We identified 2,034 (13.8%) octogenarians (age 80-89), and 222 (1.5%) nonagenarians (age 90-99). Endpoints included mortality and major adverse cardiac events (MACE) at 1 year., Materials and Methods: A total of 14,695 patients underwent PCI between 2009-2020. We identified 2,034 (13.8%) octogenarians (age 80-89), and 222 (1.5%) nonagenarians (age 90-99). Endpoints included mortality and major adverse cardiac events (MACE) at 1 year., Results: The number of nonagenarians undergoing PCI has increased substantially during the study time period, from 89 patients in the earlier time period (2009-2014) to 133 patients in the later time period (2015-2020). At 1-year, nonagenarians had significantly higher rates of both death (24.3% vs. 14.9%, p<0.01), and MACE (30.6% vs. 22.0%, p<0.01), as compared to octogenarians. The cumulative survival rate was higher among octogenarians both in the early and late time period (p<0.01 and p=0.039, respectively). A significant reduction in nonagenarian MACE rates were observed during the study time period, resulting in a non-significant difference in MACE rates in the later time period between both groups., Conclusion: The number of nonagenarians who undergo PCI is on the rise. While their clinical outcomes are inferior as compared to younger age groups, improvement was noted in the late time period., Competing Interests: Declaration of competing interest The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Southern Society for Clinical Investigation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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16. Trimethylamine-N-Oxide and Related Metabolites: Assessing Cardiovascular Risk in the Dallas Heart Study.
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Talmor-Barkan Y, Yu J, Yacovzada NS, Pravda NS, Ayers C, de Lemos JA, Tang WHW, Hazen SL, Eisen A, Witberg G, Kornowski R, and Neeland IJ
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- Humans, Male, Female, Middle Aged, Case-Control Studies, Adult, Texas epidemiology, Risk Assessment methods, Cardiovascular Diseases epidemiology, Cardiovascular Diseases blood, Atherosclerosis epidemiology, Atherosclerosis blood, Aged, Biomarkers blood, Risk Factors, Heart Disease Risk Factors, Methylamines blood, Betaine blood, Betaine analogs & derivatives, Carnitine blood, Choline blood
- Abstract
Objective: To evaluate the association between trimethylamine N-oxide (TMAO) and related metabolites with adverse cardiovascular events in a multiethnic urban primary prevention population., Methods: We performed a case-control study of 361 participants of the Dallas Heart Study, including 88 participants with an incident atherosclerotic cardiovascular disease (ASCVD) event and 273 controls matched for age, sex, and body mass index without an ASCVD event during 12 years of follow-up (January 1, 2000, through December 31, 2015). Plasma levels of TMAO, choline, carnitine, betaine, and butyrobetaine were measured by mass spectrometry. The differential odds for incident ASCVD by metabolite levels between cases and controls were compared by a conditional logistic regression model adjusted for cardiovascular risk factors., Results: Participants with incident ASCVD had higher levels of TMAO and related metabolites compared with those without ASCVD (P<.05 for all). Those with plasma TMAO concentrations in quartile 4 had a more than 2-fold higher odds of ASCVD compared with those in quartile 1 (odds ratio, 2.77 [95% CI, 1.05 to 7.7; P=.04] for hard ASCVD and 2.41 [95% CI, 1.049 to 5.709; P=.04]). Similar trends were seen with the related metabolites choline, betaine, carnitine, and butyrobetaine., Conclusion: Our results suggest that TMAO and related metabolites are independently associated with ASCVD events. Although further studies are needed, measurement of TMAO and related metabolites may have a role in ASCVD risk stratification for primary prevention., (Copyright © 2024 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)
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- 2024
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17. Greenness Exposure and Mortality Risk in a Cardio-Oncologic Population.
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Ashri S, Cohen G, Zadok OIB, Moran M, Broday DM, Steinberg DM, Keinan-Boker L, Witberg G, Bental T, Golan L, Shafran I, Kornowski R, and Gerber Y
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Background and Aims: Knowledge is lacking on the relationship between greenness and mortality in cancer survivors who experience coronary artery disease (CAD), a cardio-oncologic population. We aimed to investigate the association between residential greenness exposure and all-cause mortality in a cardio-oncologic population., Methods: Cancer survivors undergoing percutaneous coronary intervention at the Rabin Medical Center in Israel between 2004 and 2014 were included in the study. Clinical data were collected from medical records during index hospitalization and from the Israeli National Cancer Registry. Residential greenness was estimated by the normalized difference vegetation index (NDVI), a satellite-based index derived from Landsat imagery at a 30-meter spatial resolution, with larger values indicating higher levels of vegetative density (ranging between -1 to 1). Mortality follow-up data were obtained through the end of 2021. Cox models were used to assess the hazard ratios (HRs) for all-cause mortality per 1SD increase in NDVI., Results: Among 1,331 patients analyzed [mean (SD) age, 75.6 (10.2) years, 373 (28%) females], the mean (SD) NDVI within a 300-meter radius was 0.12 (0.03). During a median follow-up period of 12.0 (IQR 9.2-14.7) years, 883 (66%) participants died. After adjustment for potential confounding factors, including residential socioeconomic status, air pollution, and smoking, NDVI was inversely associated with mortality hazard [HR (95% CI) = 0.93 (0.86, 0.99); p=.042]. The association was stronger among individuals with more recently (<10 years) diagnosed cancer [HR (95% CI) = 0.89 (0.81, 0.98); p=.019]., Conclusion: In a cohort of cardio-oncologic patients, greenness was independently associated with lower mortality., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2024
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18. AI-Assisted Clinical Decision Making in Interventional Cardiology: The Potential of Commercially Available Large Language Models.
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Itelman E, Witberg G, and Kornowski R
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- Humans, Artificial Intelligence, Percutaneous Coronary Intervention instrumentation, Patient Selection, Decision Support Systems, Clinical, Predictive Value of Tests, Cardiology, Clinical Decision-Making, Decision Support Techniques
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- 2024
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19. Outcomes of Drug-Eluting Balloons for In-Stent Restenosis: Large Cohort Analysis and Single-Center Clinical Experience.
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Kheifets M, Rahat O, Bental T, Levi A, Vaknin-Assa H, Greenberg G, Codner P, Witberg G, Kornowski R, and Perl L
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- Humans, Female, Male, Aged, Percutaneous Coronary Intervention methods, Percutaneous Coronary Intervention adverse effects, Treatment Outcome, Prospective Studies, Middle Aged, Angioplasty, Balloon, Coronary methods, Follow-Up Studies, Coronary Restenosis epidemiology, Coronary Restenosis diagnosis, Drug-Eluting Stents adverse effects, Registries
- Abstract
Background: The use of drug-eluting balloons (DEBs) remains clinically relevant in the contemporary era of drug-eluting stent percutaneous coronary interventions (DES-PCI), especially in the setting of in-stent restenosis (ISR). Our goal was to assess the outcomes of ISR patients in a large prospective registry., Methods: A total of 2329 consecutive patients with ISR-PCI (675 using DEB and 1654 with DES) were treated in our medical centre from 2010 to 2021. Clinical end points included mortality and major adverse cardiac events (MACE) at 1 year. Clinical outcomes were adjusted for multiple confounders., Results: Mean ages (65.9 ± 11.0 vs 66.1 ± 10.5; P = 0.73) and percentages of female patients (16.6% vs 18.2%; P = 0.353) were similar between both ISR groups. Patients treated with DEB for ISR suffered more from diabetes, hypertension, and previous myocardial infarction (P < 0.01 for all) and presented more frequently with acute coronary syndrome (40.0% vs 34.4%; P = 0.01) compared with patients treated with DES for ISR. One-year MACE was significantly higher in the DEB ISR-PCI group (23.4% vs 19.6%; P = 0.002) compared to the DES ISR-PCI group, but no significant differences in mortality were observed at 1 year between the groups. After adjustment for multiple confounders, DEB ISR-PCI was not associated with increased MACE at 1 year (P = 0.55)., Conclusions: In our large experience, patients treated with DEB for ISR-PCI have higher baseline risk and sustained increased MACE rates compared with DES ISR-PCI patients. After adjustment for confounding variables, clinical outcomes are similar between the groups at 1 year after PCI., (Copyright © 2024 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)
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- 2024
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20. Reply: Further Analyses Required for Cerebral Embolic Protection Devices.
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Levi A, Witberg G, and Kornowski R
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- Humans, Treatment Outcome, Risk Factors, Risk Assessment, Endovascular Procedures instrumentation, Endovascular Procedures adverse effects, Embolic Protection Devices, Intracranial Embolism prevention & control, Intracranial Embolism etiology, Intracranial Embolism diagnostic imaging
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- 2024
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21. Outcomes and predictors of left ventricle recovery in patients with severe left ventricular dysfunction undergoing transcatheter aortic valve implantation.
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Witberg G, Levi A, Talmor-Barkan Y, Barbanti M, Valvo R, Costa G, Frittitta V, de Backer O, Willemen Y, van Der Dorpel M, Mon M, Sugiura A, Sudo M, Masiero G, Pancaldi E, Arzamendi D, Santos-Martinez S, Baz JA, Steblovnik K, Mauri V, Adam M, Wienemann H, Zahler D, Hein M, Ruile P, Aodha BN, Grasso C, Branca L, Estévez-Loureiro R, Amat-Santos IJ, Mylotte D, Bunc M, Tarantini G, Nombela-Franco L, Sondergaard L, Van Mieghem NM, Finkelstein A, and Kornowski R
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- Humans, Aortic Valve surgery, Heart Ventricles, Stroke Volume, Treatment Outcome, Ventricular Function, Left, Multicenter Studies as Topic, Clinical Studies as Topic, Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement adverse effects, Ventricular Dysfunction, Left
- Abstract
Background: Data on the likelihood of left ventricle (LV) recovery in patients with severe LV dysfunction and severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) and its prognostic value are limited., Aims: We aimed to assess the likelihood of LV recovery following TAVI, examine its association with midterm mortality, and identify independent predictors of LV function., Methods: In our multicentre registry of 17 TAVI centres in Western Europe and Israel, patients were stratified by baseline LV function (ejection fraction [EF] >/≤30%) and LV response: no LV recovery, LV recovery (EF increase ≥10%), and LV normalisation (EF ≥50% post-TAVI)., Results: Our analysis included 10,872 patients; baseline EF was ≤30% in 914 (8.4%) patients and >30% in 9,958 (91.6%) patients. The LV recovered in 544 (59.5%) patients, including 244 (26.7%) patients whose LV function normalised completely (EF >50%). Three-year mortality for patients without severe LV dysfunction at baseline was 29.4%. Compared to this, no LV recovery was associated with a significant increase in mortality (adjusted hazard ratio 1.32; p<0.001). Patients with similar LV function post-TAVI had similar rates of 3-year mortality, regardless of their baseline LV function. Three variables were associated with a higher likelihood of LV recovery following TAVI: no previous myocardial infarction (MI), estimated glomerular filtration rate >60 mL/min, and mean aortic valve gradient (mAVG) (expressed either as a continuous variable or as a binary variable using the standard low-flow, low-gradient aortic stenosis [AS] definition)., Conclusions: LV recovery following TAVI and the extent of this recovery are major determinants of midterm mortality in patients with severe AS and severe LV dysfunction undergoing TAVI. Patients with no previous MI and those with an mAVG >40 mmHg show the best results following TAVI, which are at least equivalent to those for patients without severe LV dysfunction. (ClinicalTrials.gov: NCT04031274).
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- 2024
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22. The Impact of Cerebral Embolic Protection Devices on Characteristics and Outcomes of Stroke Complicating TAVR.
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Levi A, Linder M, Seiffert M, Witberg G, Pilgrim T, Tomii D, Barkan YT, Van Mieghem NM, Adrichem R, Codner P, Hildick-Smith D, Arunothayaraj S, Perl L, Finkelstein A, Loewenstein I, De Backer O, Barnea R, Tarantini G, Fovino LN, Vaknin-Assa H, Mylotte D, Wagener M, Webb JG, Akodad M, Colombo A, Mangieri A, Latib A, Kargoli F, Giannini F, Ielasi A, Søndergaard L, Aviram I, Lerman TT, Kheifets M, Auriel E, and Kornowski R
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- Humans, Treatment Outcome, Risk Factors, Aortic Valve diagnostic imaging, Aortic Valve surgery, Transcatheter Aortic Valve Replacement, Ischemic Stroke etiology, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Aortic Valve Stenosis complications, Stroke diagnostic imaging, Stroke etiology, Stroke prevention & control, Embolic Protection Devices
- Abstract
Background: Acute ischemic stroke remains a serious complication of transcatheter aortic valve replacement (TAVR). Cerebral embolic protection devices (CEPD) were developed to mitigate the risk of acute ischemic stroke complicating TAVR (AISCT). However, the existing body of evidence does not clearly support CEPD efficacy in AISCT prevention., Objectives: In a cohort of patients with AISCT, we aimed to compare the characteristics and outcomes of patients who have had unprotected TAVR (CEPD-) vs CEPD-protected TAVR (CEPD+)., Methods: Data were derived from an international multicenter registry focusing on AISCT. We included all patients who experienced ischemic stroke within 72 hours of TAVR. Stroke severity was assessed using the National Institutes of Health Stroke Scale (NIHSS). Primary outcomes were neurologic disability status according to the modified Rankin Score at 30 days, and 6-month all-cause death. Propensity score matched analysis was used to control for differences between groups., Results: In 18,725 TAVR procedures, 416 AISCT (2.2%) within 72 hours were documented, of which 376 were in the CEPD- TAVR group and 40 in the CEPD+ TAVR group. Although the middle cerebral artery stroke rate was similar in both groups (29.7% CEPD- vs 33.3% CEPD+; P = 0.71), AISCT in the CEPD+ group was characterized by a lower rate of internal carotid artery occlusion (0% vs 4.7%) and higher rate of vertebrobasilar system strokes (15.4% vs 5.7%; P = 0.04). AISCT was severe (NIHSS ≥15) in 21.6% CEPD- and 23.3% CEPD+ AISCT (P = 0.20). Disabling stroke rates (modified Rankin Score >1 at 30 days) were 47.3% vs 42.5% (P = 0.62), and 6-month mortality was 31.3% vs 23.3% (P = 0.61), in the CEPD- and CEPD+ groups, respectively. In the propensity score matched cohort, disabling stroke rates were 56.5% vs 41.6% (P = 0.16), and 6-month mortality was 33% vs 19.5% (P = 0.35), in the CEPD- and CEPD+ groups, respectively., Conclusions: In a large cohort of patients with AISCT, the use of CEPD had little effect on stroke distribution, severity, and outcomes., Competing Interests: Funding Support and Author Disclosures Dr Seiffert has received speaker or advisory fees from Abbott Vascular, Abiomed, Amgen, AstraZeneca, Boston Scientific, Bristol Myers Squibb, Daiichi-Sankyo, Edwards Lifesciences, Inari Medical, Medtronic, Pfizer, Shockwave Medical, and Siemens Healthineers; and a research grant from Boston Scientific—all unrelated to the submitted work. Dr Pilgrim has received institutional research grants from Edwards Lifesciences, Boston Scientific, and Biotronik; and personal fees from Biotronik, Boston Scientific, Medtronic, Abbott, and Edwards Lifesciences. Dr Van Mieghem has received research grant support from Abbott Vascular, Boston Scientific, Medtronic, Edwards Lifesciences, Daiichi-Sankyo, and AstraZeneca, and advisory/consultancy/speaker fees from JenaValve, Anteris, Siemens, Pie Medical, Materialise, Amgen, Abbott Vascular, Boston Scientific, Medtronic, Daiichi-Sankyo, Teleflex, and PulseCath BV. Dr Perl is a consultant for Edwards Lifesciences. Dr De Backer has received research grants and consultant fees from Abbott and Boston Scientific. Dr Wagener has received educational support from Medtronic. Dr Webb has been a consultant to, and has received research funding from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Akodad has received research funding from Medtronic, Biotronik, MUSE Explore, and Federation Française de Cardiologie; and is a consultant for Medtronic and Edwards Lifesciences. Dr Mangieri has received an institutional research grant from Boston Scientific; and has served on a medical advisory board for Boston Scientific. Dr Latib has served on advisory boards for Medtronic and Abbott; and has been a consultant to Edwards Lifesciences. Dr Søndergaard is chief medical officer at Abbott Structural Heart; and has received consultant fees and/or institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and SMT. 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. All rights reserved.)
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- 2024
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23. Novel plasma biomarkers of coronary artery calcium incidence or progression: Insights from the prospective multi-ethnic Dallas Heart Study cohort.
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Grinberg T, Eisen A, Talmor-Barkan Y, Kornowski R, Hamdan A, Witberg G, Ayers C, Joshi P, Rohatgi A, Khera A, de Lemos JA, and Neeland IJ
- Subjects
- Humans, Male, Adult, Female, Calcium metabolism, Prospective Studies, Coronary Vessels diagnostic imaging, Coronary Vessels metabolism, Incidence, Risk Factors, Biomarkers metabolism, Calcium, Dietary, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease epidemiology, Atherosclerosis metabolism, Vascular Calcification diagnostic imaging, Vascular Calcification epidemiology, Vascular Calcification metabolism
- Abstract
Background and Aims: Identifying the association of novel plasma biomarkers with coronary artery calcium (CAC) incidence or progression may provide insights into the pathophysiology of atherogenesis and plaque formation., Methods: Participants of the Dallas Heart Study (DHS), a multi-ethnic cohort of ambulatory individuals at low-intermediate risk for future atherosclerotic cardiovascular disease (ASCVD), who had their blood tested for 31 biomarkers reflecting multiple pathophysiological pathways, underwent 2 serial non-contrast computed tomography assessments for CAC a median ∼7 years apart. The collected biomarkers were explored for association with CAC incidence or progression using univariate and multivariate analysis., Results: A total of 1424 participants were included; mean age 43 years, 39 % male, and nearly half African-American. Over a 7-year interval between the two CAC measurements, 340 participants (23.9 %) had CAC incidence or progression, 105 (7.4 %) with incident CAC, and 309 (21.7 %) with CAC progression. Although several plasma biomarkers were associated with CAC incidence or progression in a univariate model, only soluble intercellular adhesion molecule-1 (sICAM-1), related to atherosclerosis by the inflammatory pathway, remained independently associated in a multivariate model adjusted for traditional risk factors., Conclusions: Further studies are needed to characterize the role of sICAM-1 in CAC evolvement to establish whether it has a pivotal mechanistic contribution or is rather an innocent bystander. Alternate measures of coronary atherosclerosis may be needed to elucidate contributors to atherosclerosis incidence or progression., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Neeland has been a speaker/consultant for Boehringer-Ingelheim/Lilly Alliance and Bayer Pharmaceuticals and has been an advisory board member for AMRA Medical, Boehringer Ingelheim, Bayer, and Lilly. Dr. Eisen has been a speaker/consultant/ Advisory board member for Boehringer-Ingelheim, Bayer, Novo Nordisk, AstraZeneca, Pfizer, Neopharm, Medison Pharma, and Sanofi. Dr. de Lemos reports grant support from Roche Diagnostics and Abbott Diagnostics, consulting fees from Quidel Cardiovascular, Inc., Cytokinetics and Glaxo Smith Kline, honoraria for participation in endpoint committees from Beckman Coulter and Siemens Health Care Diagnostics, and fees for participation in Data Monitoring Committees from Astra Zeneca, Novo Nordisk, Eli Lilly, Regeneron, Amgen, and Verve Therapeutics., (Copyright © 2024 Elsevier B.V. All rights reserved.)
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- 2024
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24. Percutaneous Coronary Interventions Using a Ridaforolimus-Eluting Stent in Patients at High Bleeding Risk.
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Kornowski R, Konigstein M, Jonas M, Assali A, Vaknin-Assa H, Segev A, Danenberg H, Halabi M, Roguin A, Kerner A, Lev E, Karamasis GV, Johnson TW, Anderson R, Blaxill J, Jadhav S, Hoole S, Witberg G, Issever MO, Ben-Yehuda O, and Baumbach A
- Subjects
- Humans, Platelet Aggregation Inhibitors therapeutic use, Prospective Studies, Treatment Outcome, Hemorrhage chemically induced, Stents, Drug Therapy, Combination, Drug-Eluting Stents, Acute Coronary Syndrome drug therapy, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention methods, Thrombosis etiology, Coronary Artery Disease drug therapy, Sirolimus analogs & derivatives
- Abstract
Background: Patients treated with percutaneous coronary intervention are often considered to be at a high bleeding risk (HBR). Drug-eluting stents have been shown to be superior to bare-metal stents in patients with HBR, even when patients were given abbreviated periods of dual antiplatelet therapy (DAPT). Short DAPT has not been evaluated with the EluNIR ridaforolimus-eluting stent. The aim of this study was to evaluate the safety and efficacy of a shortened period of DAPT following implantation of the ridaforolimus-eluting stent in patients with HBR., Methods and Results: This was a prospective, multicenter, binational, single-arm, open-label trial. Patients were defined as HBR according to the LEADERS-FREE (Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug-Coated Stent versus the Gazelle Bare-Metal Stent in Patients at High Bleeding Risk) trial criteria. After percutaneous coronary intervention, DAPT was given for 1 month to patients presenting with stable angina. In patients presenting with an acute coronary syndrome, DAPT was given for 1 to 3 months, at the investigator's discretion. The primary end point was a composite of cardiac death, myocardial infarction, or stent thrombosis up to 1 year (Academic Research Consortium definite and probable). Three hundred fifteen patients undergoing percutaneous coronary intervention were enrolled, and 56.4% presented with acute coronary syndrome; 33.7% were receiving oral anticoagulation. At 1 year, the primary end point occurred in 15 patients (4.9%), meeting the prespecified performance goal of 14.1% ( P <0.0001). Stent thrombosis (Academic Research Consortium definite and probable) occurred in 2 patients (0.6%). Bleeding Academic Research Consortium type 3 and 5 bleeding occurred in 6 patients (1.9%)., Conclusions: We observed favorable results in patients with HBR who underwent percutaneous coronary intervention with a ridaforolimus-eluting stent and received shortened DAPT, including a low rate of ischemic events and low rate of stent thrombosis., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03877848.
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- 2024
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25. Percutaneous coronary intervention with ridaforolimus eluting-stents in small vessel coronary artery disease.
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Arow Z, Konigstein M, Vaknin-Assa H, Witberg G, Jonas M, Kerner A, Cafri C, Rubinshtein R, Segev A, Roguin A, Issever MO, Gabarin M, Pereg D, Assali A, and Koifman E
- Subjects
- Humans, Constriction, Pathologic, Prospective Studies, Prosthesis Design, Treatment Outcome, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease therapy, Coronary Artery Disease etiology, Drug-Eluting Stents, Percutaneous Coronary Intervention
- Abstract
Introduction: The ridaforolimus-eluting stent (RES) system uses a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus., Aim of Study: To assess the safety and efficacy of small diameter (2.25 mm) RES (EluNIR) in small coronary artery disease., Methods: A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameter of ≥2.25 mm to ≤2.5 mm. The primary endpoint was combined device success, defined as final in-stent residual diameter stenosis <30%, without 30-day major adverse cardiovascular events (MACE)., Results: A total of 81 patients were enrolled in the study. Twenty-three patients (28%) had acute coronary syndrome (ACS) at presentation and 37 (46%) had prior myocardial infarction (MI). Most of the target lesions were located in the circumflex coronary artery (44%) and were classified as B2/C grade according to the American Heart Association/American College of Cardiology classification. The final mean minimal lumen diameter, mean reference vessel diameter, and mean residual percent diameter stenosis were 2.0 ± 0.2 mm, 2.3 ± 0.1 mm, and 14 + 6.6%, respectively. The primary endpoint of device success without 30-day MACE was achieved in 98.8% of the patients. Target lesion failure (TLF) at 6 months was 1.2%. Thirty-day and 1-year MACE rates were 1.2% and 2.5%, respectively., Conclusion: The EluNIR 2.25 mm stent shows excellent results in small coronary artery disease and adds another tool in the treatment of this complex lesion type., (© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)
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- 2024
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26. The Clinical SYNTAX score predicts survival better than the SYNTAX score in coronary revascularization.
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Barac YD, Witberg G, Assali A, Klempfner R, Krutzwald-Josefson E, Rubchevsky V, Abergel E, Kornowski R, and Aravot D
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- Humans, Coronary Angiography, Treatment Outcome, Risk Factors, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease surgery, Percutaneous Coronary Intervention
- Abstract
Background: The Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) trial showed that the SYNTAX score (SS) is a useful tool for customizing revascularization treatment for patients with multivessel coronary disease. In the past decade, the Clinical SS (CSS) has emerged as a comprehensive tool. This novel tool considers the SS as well as patient clinical parameters such as age, creatinine clearance, and ejection fraction, which were shown to be relevant for patient prognosis. Thus, in the current work we set out to compare the survival predictive values of the SS versus the CSS and their future application in real-world implementation of the revascularization guidelines., Methods: This study was a subanalysis of data collected in a prospective national registry in Israel that enrolled consecutive patients with left main and/or 2- to 3-vessel coronary artery disease involving the proximal or mid-left anterior descending artery; the MULTI-vessel Coronary Artery Disease (MULTICAD). The revascularization method was chosen by the physicians taking care of the patients at each hospital and the patients were followed for 5 years. Patients were categorized according to their SS, the CSS, and their revascularization method (primary coronary intervention [PCI] vs coronary artery bypass grafting [CABG]) and patient survival were compared., Results: A total of 585 patients were enrolled in the study and were followed for 5 years. The median CSS was 27, with 288 patients showing a CSS ≥27, with a mean CSS of 47.85 and a mean SS of 29.05. At 3 and 5 years post-treatment, the CSS ≥27 group had a lower survival probability, CSS ≥27 was associated with a lower survival probability among patients who underwent PCI compared with those who underwent CABG. More specifically, the high-CSS CABG group had a 5-year mortality rate of 16.8%, whereas the high-CSS PCI group had a 5-year mortality rate of 32.2%. In a comparison of SS with CSS for the 5-year mortality outcome prediction, CSS was superior to SS with a higher area under the curve., Conclusions: This prospective registry of real-world revascularization strategies in patients with multivessel disease showed that CSS is a better predictive tool of postrevascularization survival than SS. Moreover, it showed that surgical revascularization in patients with CSS ≥27 is associated with better all-cause mortality outcome after CABG as compared with after PCI. This attests to the need for a score that considers clinical parameters in a real-world scenario., (Copyright © 2022 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2024
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27. Cardiac Magnetic Resonance Imaging in COVID-19 Vaccine-Associated Myocarditis Compared With Classical Myocarditis.
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Aviv Y, Shiyovich A, Plakht Y, Witberg G, Weissman M, Shafir G, Kornowski R, and Hamdan A
- Abstract
Background: Studies comparing COVID-19 vaccine-associated and classical myocarditis (CM) are lacking., Objectives: The purpose of this study was to compare cardiac magnetic resonance (CMR) imaging findings and short-term clinical outcomes in patients with messenger RNA COVID-19 postvaccination myocarditis (PVM) and CM., Methods: This was a retrospective study of patients with myocarditis: 31 with PVM and 46 with CM. Patients underwent a CMR protocol scan including T1 and T2 sequences. Late gadolinium enhancement (LGE) was expressed as percentage of left ventricular myocardial mass and the extracellular volume was calculated based on precontrast and postcontrast T1 images. Clinical outcomes included heart failure hospitalizations and mortality., Results: Study patients were predominantly male (81% in PVM vs 89% in CM, P = 0.330). Patients with PVM had lower T1 values compared with CM (1,064.2 ± 67.0 ms vs 1,081.6 ± 41.9 ms, P = 0.032), although T2 and extracellular volume values were similar in both groups. Left ventricular ejection fraction and LGE were similar in both groups. The most frequent location of LGE was the basal inferolateral wall. PVM more commonly demonstrated a mid-wall LGE pattern while CM demonstrated a subepicardial LGE pattern. Compared with CM, patients with PVM were more likely to have a pericardial effusion (42% vs 17%, P = 0.018) and pericardial LGE (38% vs 13%, P = 0.009). During short-term follow-up (median 300 days for PVM, 319 days for CM), there were no deaths or heart failure hospitalizations in either group., Conclusions: Our study shows similar CMR imaging findings and short-term outcomes in PVM and CM, although PVM was associated with milder myocardial abnormalities and more frequent pericardial involvement., Competing Interests: The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2023 The Authors.)
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- 2023
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28. Transcatheter aortic valve implantation in patients with extra-small aortic annuli.
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Tirado-Conte G, Rodés-Cabau J, Oteo JF, Pan M, Muñoz E, Witberg G, Cheema AN, Alpieri A, Lopez D, Amat-Santos IJ, Akodad M, Ojeda S, Serra V, Garcia-Blas S, Alfonso F, De Backer O, Asmarats L, Muñoz A, Hamdan A, Toggweiler S, Del Valle R, Salido L, Cruz-González I, Estevez-Loureiro R, Martin Alfaro LE, Gheorge L, Dabrowski M, Berenguer A, Arzamendi D, Saia F, Webb JG, Sondergaard L, and Nombela-Franco L
- Subjects
- Humans, Female, Male, Aortic Valve diagnostic imaging, Aortic Valve surgery, Prosthesis Design, Risk Factors, Treatment Outcome, Transcatheter Aortic Valve Replacement adverse effects, Aortic Valve Stenosis surgery, Heart Valve Prosthesis
- Abstract
Background: A small aortic annulus (SAA) is a risk factor for prosthesis-patient mismatch (PPM) in patients undergoing surgical or transcatheter aortic valve implantation (TAVI). Data regarding TAVI in patients with extra-SAA are scarce., Aims: The aim of this study was to analyse the safety and efficacy of TAVI in patients with extra-SAA., Methods: A multicentre registry study including patients with extra-SAA (defined as an aortic annulus area <280 mm
2 and/or perimeter <60 mm) undergoing TAVI was established. Primary efficacy and safety endpoints were defined as device success and early safety at 30 days, respectively, using the Valve Academic Research Consortium-3 criteria, and were analysed according to valve type: self-expanding (SEV) versus balloon-expandable (BEV)., Results: A total of 150 patients were included, of which 139 (92.7%) were women, and 110 (73.3%) received an SEV. Intraprocedural technical success was 91.3%, with a higher rate in patients receiving an SEV (96.4% vs 77.5% with BEV; p=0.001). Overall, 30-day device success was 81.3%, (85.5% with SEV vs 70.0% with BEV; p=0.032). The primary safety endpoint occurred in 72.0% of patients (with no difference between groups; p=0.118). Severe PPM occurred in 12% (9.0% with SEV and 24.0% with BEV; p=0.039), with no impact on all-cause mortality, cardiovascular mortality, or heart failure readmission at 2-year follow-up., Conclusions: TAVI is a safe and feasible treatment in patients with extra-SAA with a high rate of technical success. The use of SEV was associated with a lower rate of intraprocedural complications, higher device success at 30 days and better haemodynamic outcomes compared to BEV.- Published
- 2023
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29. More on Myocarditis after BNT162b2 Vaccination in Israeli Adolescents. Reply.
- Author
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Witberg G
- Subjects
- Humans, Adolescent, BNT162 Vaccine, Israel epidemiology, Myocarditis epidemiology, Myocarditis etiology
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- 2023
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30. Transcatheter Interventions for Atrioventricular Dysfunction in Patients with Adult Congenital Heart Disease: An International Case Series.
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Schamroth Pravda N, Vaknin Assa H, Sondergaard L, Bajoras V, Sievert H, Piayda K, Levi A, Witberg G, Shapira Y, Hamdan A, Perl L, Vig S, Blieden L, Kornowski R, Hirsch R, and Codner P
- Abstract
Introduction: A substantial proportion of patients with adult congenital heart disease (ACHD) suffer from worsening valvular dysfunction in adulthood. Transcatheter valve interventions can offer a therapeutic alternative to surgery for those at high surgical risk. There is emerging but limited data on transcatheter interventions for atrioventricular (AV) valve dysfunction in patients with ACHD., Methods: We compiled an international collaborative multi-center registry focusing on adult patients with congenital heart disease undergoing transcatheter AV valve interventions (repair or replacement). Included were patients from three international centers who underwent procedures between 2016 and 2022. Demographic, clinical, and procedural data were compiled., Results: Nine patients with ACHD underwent AV valve interventions. The median age was 48 years (IQR (37; 56), 55% women). At baseline, seven patients (78%) were in NYHA functional class III and two (22%) were in NYHA functional class II. The diagnosis of ACHD varied. Three valve interventions were performed on the subpulmonary AV valve and six on the systemic AV valve. The primary valvular pathology was regurgitation (six patients, 78%). Five procedures were valve-in-valve interventions, and four procedures were transcatheter edge-to-edge repair procedures. There were no major complications or peri-procedural complications or peri-procedural mortality. One patient developed a suspected non-obstructive thrombus on the valve that was medically treated. One patient did not improve clinically following the procedure and underwent a heart transplant, one patient died 6 months following the procedure due to a cardiovascular implantable electronic device infection. At one year, six patients were in NYHA functional class I, and one patient was in NYHA functional class III. In conclusion, transcatheter AV heart valve interventions are feasible and safe procedures in carefully selected ACHD patients. These procedures can offer an effective treatment option in these younger patients with high surgical risk.
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- 2023
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31. Head-to-head efficacy and safety of rivaroxaban, apixaban, and dabigatran in an observational nationwide targeted trial.
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Talmor-Barkan Y, Yacovzada NS, Rossman H, Witberg G, Kalka I, Kornowski R, and Segal E
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- Humans, Dabigatran adverse effects, Rivaroxaban adverse effects, Retrospective Studies, Anticoagulants, Gastrointestinal Hemorrhage chemically induced, Brain Ischemia, Stroke diagnosis, Stroke epidemiology, Stroke prevention & control, Atrial Fibrillation diagnosis, Atrial Fibrillation drug therapy, Atrial Fibrillation chemically induced
- Abstract
Aims: The advantages of direct oral anticoagulants (DOACs) over warfarin are well established in atrial fibrillation (AF) patients, however, studies that can guide the selection between different DOACs are limited. The aim was to compare the clinical outcomes of treatment with apixaban, rivaroxaban, and dabigatran in patients with AF., Methods and Results: We conducted a retrospective, nationwide, propensity score-matched-based observational study from Clalit Health Services. Data from 141 992 individuals with AF was used to emulate a target trial for head-to-head comparison of DOACs therapy. Three-matched cohorts of patients assigned to DOACs, from January-2014 through January-2020, were created. One-to-one propensity score matching was performed. Efficacy/safety outcomes were compared using KaplanMeier survival estimates and Cox proportional hazards models. The trial included 56 553 patients (apixaban, n = 35 101; rivaroxaban, n = 15 682; dabigatran, n = 5 770). Mortality and ischaemic stroke rates in patients treated with rivaroxaban were lower compared with apixaban (HR,0.88; 95% CI,0.78-0.99; P,0.037 and HR 0.92; 95% CI,0.86-0.99; P,0.024, respectively). No significant differences in the rates of myocardial infarction, systemic embolism, and overall bleeding were noticed between the different DOACs groups. Patients treated with rivaroxaban demonstrated lower rate of intracranial haemorrhage compared with apixaban (HR,0.86; 95% CI,0.74-1.0; P,0.044). The rate of gastrointestinal bleeding in patients treated with rivaroxaban was higher compared with apixaban (HR, 1.22; 95% CI,1.01-1.44; P, 0.016)., Conclusion: We demonstrated significant differences in outcomes between the three studied DOACs. The results emphasize the need for randomized controlled trials that will compare rivaroxaban, apixaban, and dabigatran in order to better guide the selection among them., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2022
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32. A Tale of 2 mRNA Vaccines: The Spring of Hope, The Winter of Despair.
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Witberg G and Richter I
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- Humans, Adaptation, Psychological, mRNA Vaccines, Myocarditis, Pericarditis
- Abstract
Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Published
- 2022
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33. Myocarditis after BNT162b2 Vaccination in Israeli Adolescents.
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Witberg G, Magen O, Hoss S, Talmor-Barkan Y, Richter I, Wiessman M, Aviv Y, Grinberg T, Shiyovich A, Schamroth-Pravda N, Auster O, Dagan N, Birk E, Balicer R, and Kornowski R
- Subjects
- Adolescent, Humans, Israel epidemiology, Vaccination adverse effects, White People, BNT162 Vaccine adverse effects, BNT162 Vaccine therapeutic use, Myocarditis epidemiology, Myocarditis etiology, COVID-19 prevention & control
- Published
- 2022
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34. Myocarditis Following COVID-19 Vaccination: A Follow-up Magnetic Resonance Imaging Study.
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Shiyovich A, Plakht Y, Witberg G, Aviv Y, Shafir G, Kornowski R, and Hamdan A
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- Humans, Follow-Up Studies, Magnetic Resonance Imaging methods, Predictive Value of Tests, Vaccination adverse effects, COVID-19 prevention & control, COVID-19 Vaccines adverse effects, Myocarditis diagnostic imaging, Myocarditis etiology, Myocarditis pathology
- Published
- 2022
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35. Myocarditis following COVID-19 vaccination in adolescents: Cardiac magnetic resonance imaging study.
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Shiyovich A, Plakht Y, Witberg G, Rotstein A, Aviv Y, Wiessman M, Kornowski R, and Hamdan A
- Abstract
Introduction: Vaccination-associated myocarditis was reported following COVID-19 vaccine initially among persons aged 16 or older and recently among adolescents aged 12-15., Objectives: To describe the clinical and cardiac magnetic resonance (CMR) characteristics of adolescents aged 12-15 with myocarditis following the administration of the BNT162b2 mRNA COVID-19 vaccine., Methods: CMR of adolescents (age 12-15) with a clinical diagnosis of myocarditis within 42 days following the first COVID-19 vaccine were analyzed., Results: A total of 182,605 adolescent were vaccinated, out of which 9 were diagnosed with clinically adjudicated myocarditis while CMR was performed in 5/9 patients (56%). Median age was 15 years (range 13-15), 4/5 (80%) males. All the patients we previously healthy. The ECG upon presentation was abnormal in 3/5 (60%) of patients. All cases were classified as clinically mild and no patient required inotropes or mechanical circulatory support treatment. The median follow-up time, for the 5-included patients, was 206 (IQR 192-229, range 179-233) days. During the follow-up, no re-admissions, deaths, or any other cardiac events have occurred.The median time between the diagnosis to the CMR was 104 days (range 27-149). The median left ventricular ejection fraction was within normal range 65% (range 62-69). Native T1 was available in four patients, the local T1 value was increased in three of them. T2 values were available in two patients and were all within normal range. The median late gadolinium enhancement (LGE) was 2% (range 0-6%) with inferolateral wall being the most common location (3/5). The patterns of the LGE were as following: (i) mid-wall in 3 patients; (ii) epicardial in 1-patient. LGE in the pericardium was present in 2/5 patients with pericardial effusion present in 4/5 patients with a median diameter of 4 mm (range 3-5 mm) at end-systole., Conclusions: CMR findings and clinical course of adolescents with COVID-19 vaccination associated myocarditis, are similar to those of older patients, being relatively mild and potentially implying favorable outcomes., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Shiyovich, Plakht, Witberg, Rotstein, Aviv, Wiessman, Kornowski and Hamdan.)
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- 2022
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36. Management and Outcome of Acute Ischemic Stroke Complicating Transcatheter Aortic Valve Replacement.
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Levi A, Linder M, Seiffert M, Witberg G, Pilgrim T, Tomii D, Talmor-Barkan Y, Van Mieghem NM, Adrichem R, Codner P, Smith DH, Arunothayaraj S, Perl L, Finkelstein A, Loewenstein I, Findler M, Søndergaard L, De Backer O, Wang C, Barnea R, Tarantini G, Fovino LN, Vaknin-Assa H, Mylotte D, Lunardi M, Raphaeli G, Webb JG, Akodad M, Colombo A, Mangieri A, Latib A, Kargoli F, Giannini F, Ielasi A, Cockburn J, Higgen FL, Aviram I, Gitto M, Hokken TW, Auriel E, and Kornowski R
- Subjects
- Aortic Valve diagnostic imaging, Aortic Valve surgery, Humans, Postoperative Complications etiology, Registries, Risk Factors, Treatment Outcome, Aortic Valve Stenosis complications, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Ischemic Stroke, Stroke diagnostic imaging, Stroke etiology, Stroke therapy, Transcatheter Aortic Valve Replacement adverse effects
- Abstract
Background: Despite advances in transcatheter aortic valve replacement (TAVR), periprocedural acute ischemic stroke remains a concern., Objectives: The aims of this study were to investigate acute ischemic stroke complicating TAVR (AISCT) and to describe the indications and outcomes of interventions to treat AISCT., Methods: An international multicenter registry was established focusing on AISCT within 30 days of TAVR. Stroke severity was assessed using the National Institutes of Health Stroke Scale. Primary outcomes were 1-year all-cause death and neurologic disability status at 90 days according to modified Rankin scale score., Results: Of 16,615 TAVR procedures, 387 patients with AISCT were included (2.3%). Rates of 1-year death were 28.9%, 35.9%, and 77.5% in patients with mild, moderate, and severe stroke, respectively (P < 0.001). Although 348 patients were managed conservatively, 39 patients (10.1%) underwent neurointervention (NI) with either mechanical thrombectomy (n = 26) or thrombolytic therapy (n = 13). In a subanalysis excluding patients with mild stroke, there was no clear 1-year survival benefit for NI compared with conservative management (47.6% vs 41.1%, respectively; P = 0.78). In a logistic regression model controlling for stroke severity, NI was associated with 2.9-fold odds (95% CI: 1.2-7.0; P = 0.016) of independent survival at 90 days., Conclusions: AISCT carries significant morbidity and mortality, which is correlated with stroke severity. The present findings suggest that neurologic disability for patients with moderate or worse stroke could potentially be improved by timely intervention and highlight the importance of collaboration between cardiologists and neurologists to optimize AISCT outcomes., Competing Interests: Funding Support and Author Disclosures Dr Pilgrim has received research grants to the institution from Edwards Lifesciences, Boston Scientific, and Biotronik; has received personal fees from Biotronik and Boston Scientific; has received other compensation from HighLife SAS and Medira; and is a proctor for Medtronic. Dr De Backer has received research grants and consulting fees from Abbott and Boston Scientific. Dr Søndergaard has received consulting fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Van Mieghem has received research grant support from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, PulseCath BV, and Daiichi Sankyo; and has received advisory fees from Abbott, Boston Scientific, Ancora, Medtronic, PulseCath BV, and Daiichi Sankyo. Dr Webb has been a consultant to and has received research funding from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Cockburn is a proctor for Boston Scientific. Dr Seiffert has served as a consultant for JenaValve and Boston Scientific; has received travel compensation from Edwards Lifesciences, JenaValve, Boston Scientific, and Biotronik; and has received speaker honoraria from Medtronic. Dr Mangieri has received a research grant (to the institution) from Boston Scientific; and has served on a medical advisory board for Boston Scientific. Dr Latib has served on advisory boards for Medtronic and Abbott; and has been a consultant to Edwards Lifesciences. Dr Akodad has received research funding from Medtronic, Biotronik, MUSE Explore, and Federation Française de Cardiologie. Dr Perl is a consultant for Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022. Published by Elsevier Inc.)
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- 2022
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37. Outcomes of Redo Transcatheter Aortic Valve Replacement According to the Initial and Subsequent Valve Type.
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Landes U, Richter I, Danenberg H, Kornowski R, Sathananthan J, De Backer O, Søndergaard L, Abdel-Wahab M, Yoon SH, Makkar RR, Thiele H, Kim WK, Hamm C, Buzzatti N, Montorfano M, Ludwig S, Schofer N, Voigtlaender L, Guerrero M, El Sabbagh A, Rodés-Cabau J, Mesnier J, Okuno T, Pilgrim T, Fiorina C, Colombo A, Mangieri A, Eltchaninoff H, Nombela-Franco L, Van Wiechen MPH, Van Mieghem NM, Tchétché D, Schoels WH, Kullmer M, Barbanti M, Tamburino C, Sinning JM, Al-Kassou B, Perlman GY, Ielasi A, Fraccaro C, Tarantini G, De Marco F, Witberg G, Redwood SR, Lisko JC, Babaliaros VC, Laine M, Nerla R, Finkelstein A, Eitan A, Jaffe R, Ruile P, Neumann FJ, Piazza N, Sievert H, Sievert K, Russo M, Andreas M, Bunc M, Latib A, Bruoha S, Godfrey R, Hildick-Smith D, Barbash I, Segev A, Maurovich-Horvat P, Szilveszter B, Spargias K, Aravadinos D, Nazif TM, Leon MB, and Webb JG
- Subjects
- Aortic Valve diagnostic imaging, Aortic Valve surgery, Humans, Prosthesis Design, Registries, Risk Factors, Treatment Outcome, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Heart Valve Prosthesis, Transcatheter Aortic Valve Replacement
- Abstract
Background: As transcatheter aortic valve (TAV) replacement is increasingly used in patients with longer life expectancy, a sizable proportion will require redo TAV replacement (TAVR). The unique configuration of balloon-expandable TAV (bTAV) vs a self-expanding TAV (sTAV) potentially affects TAV-in-TAV outcome., Objectives: The purpose of this study was to better inform prosthesis selection, TAV-in-TAV outcomes were assessed according to the type of initial and subsequent TAV., Methods: Patients from the Redo-TAVR registry were analyzed using propensity weighting according to their initial valve type (bTAV [n = 115] vs sTAV [n = 106]) and subsequent valve type (bTAV [n = 130] vs sTAV [n = 91])., Results: Patients with failed bTAVs presented later (vs sTAV) (4.9 ± 2.1 years vs 3.7 ± 2.3 years; P < 0.001), with smaller effective orifice area (1.0 ± 0.7 cm
2 vs 1.3 ± 0.8 cm2 ; P = 0.018) and less frequent dominant regurgitation (16.2% vs 47.3%; P < 0.001). Mortality at 30 days was 2.3% (TAV-in-bTAV) vs 0% (TAV-in-sTAV) (P = 0.499) and 1.7% (bTAV-in-TAV) vs 1.0% (sTAV-in-TAV) (P = 0.612); procedural safety was 72.6% (TAV-in-bTAV) vs 71.2% (TAV-in-sTAV) (P = 0.817) and 73.2% (bTAV-in-TAV) vs 76.5% (sTAV-in-TAV) (P = 0.590). Device success was similar according to initial valve type but higher with subsequent sTAV vs bTAV (77.2% vs 64.3%; P = 0.045), primarily because of lower residual gradients (10.3 mm Hg [8.9-11.7 mm Hg] vs 15.2 mm Hg [13.2-17.1 mm Hg]; P < 0.001). Residual regurgitation (moderate or greater) was similar after bTAV-in-TAV and sTAV-in-TAV (5.7%) and nominally higher after TAV-in-bTAV (9.1%) vs TAV-in-sTAV (4.4%) (P = 0.176)., Conclusions: In selected patients, no association was observed between TAV type and redo TAVR safety or mortality, yet subsequent sTAV was associated with higher device success because of lower redo gradients. These findings are preliminary, and more data are needed to guide valve choice for redo TAVR., Competing Interests: Funding Support and Author Disclosures Dr Webb is a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, and Boston Scientific. Dr Kim is a proctor for and has received speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, and Medtronic. Dr Abdel-Wahab has received speaker honoraria and/or consultancy fees to the hospital on his behalf from Boston Scientific and Medtronic. Dr Barbanti is a consultant for Edwards Lifesciences; and is an advisory board member for Biotronik. Dr Søndergaard has received consulting fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. Dr Redwood is a proctor for and has received lecture fees from Edwards Lifesciences. Dr Hamm is an advisory board member for Medtronic. Dr Sinning has received speaker honoraria and research grants from Medtronic, Boston Scientific, and Edwards Lifesciences. Dr Sathananthan is a consultant to Edwards Lifesciences. Dr Schofer has received speaker fees and travel compensation from Boston Scientific; and has received travel compensation from Edwards Lifesciences and Abbott/St. Jude Medical. Dr Andreas is a proctor, consultant, and speaker for Edwards Lifesciences, Abbott, and Medtronic; and has received institutional grants from Edwards Lifesciences, Abbott, Medtronic, and LSI. Dr Guerrero has received research grant support from Abbott Vascular and Edwards Lifesciences. Dr Castriota is a proctor for Medtronic and Boston Scientific. Dr Nazif is a consultant for or has received honoraria from Edwards Lifesciences, Medtronic, Boston Scientific, Biotrace, and Baylis Medical; and is a consultant for and holds equity in Venus Medtech. Dr Pilgrim has received research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; and has received speaker fees from Boston Scientific and Biotronik. Dr Babaliaros is a consultant to Edwards Lifesciences; and holds equity in Transmural Systems. Dr Van Mieghem has received institutional research grants and consulting fees from Abbott, Boston Scientific, Medtronic, Daiichi Sankyo, and PulseCath; and has received institutional research grant support from Edwards Lifesciences. Dr Latib has received institutional research and grant support from Abbott, Boston Scientific, Medtronic, and Edwards Lifesciences; and has received personal consulting honoraria from Abbott, Edwards Lifesciences, and Medtronic. Dr Hildick-Smith is a proctor and adviser for Boston Scientific, Medtronic, and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022. Published by Elsevier Inc.)- Published
- 2022
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38. Myocarditis following COVID-19 vaccination: magnetic resonance imaging study.
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Shiyovich A, Witberg G, Aviv Y, Eisen A, Orvin K, Wiessman M, Grinberg T, Porter A, Kornowski R, and Hamdan A
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- Adult, Contrast Media, Female, Gadolinium, Humans, Magnetic Resonance Imaging, Cine, Male, Retrospective Studies, Vaccination adverse effects, Young Adult, BNT162 Vaccine adverse effects, COVID-19 prevention & control, Myocarditis diagnostic imaging, Myocarditis etiology
- Abstract
Aims: To describe the cardiac magnetic resonance (CMR) imaging findings of patients who developed myocarditis following messenger RNA (mRNA) coronavirus disease 2019 (COVID-19) vaccination., Methods and Results: The present study retrospectively evaluated patients with clinically adjudicated myocarditis within 42 days of the first Pfizer-BNT162b2 mRNA COVID-19 vaccination, between 20 December 2020 and 24 May 2021 who underwent CMR. A total of 15 out 54 patients (28%) with myocarditis underwent a CMR and were included, 100% males, median age of 32 years (interquartile range = 22.5-40). Most patients presented with chest pain (87%) and had an abnormal electrocardiogram (79%). The severity of the disease was mild in 67% and intermediate in 33%. All patients survived and one patient was readmitted during the study period. CMR was performed at a median of 65 days (range 3-130 days) following diagnosis. Median ejection fraction was 58% (range 51-74%) global- and regional wall motion abnormalities were present in one and three patients, respectively. Native T1 was available in 13/15 patients (2/3 in 3 T and 11/12 in the 1.5 T), with increased values among 6/13. Late gadolinium enhancement (LGE) was found among 13/15 patients with a median of 2% (range 0-15%) with inferolateral wall being the most common location (8/13). The patterns of the LGE were: mid-wall in six patients; epicardial in five patients; and mid-wall and epicardial in two patients., Conclusions: Among patients who were diagnosed with post-vaccination clinical myocarditis, CMR imaging findings are mild and consistent with 'classical myocarditis'. The short-term clinical course and outcomes were favourable., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)
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- 2022
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39. Center Valve Preference and Outcomes of Transcatheter Aortic Valve Replacement: Insights From the AMTRAC Registry.
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Witberg G, Landes U, Talmor-Barkan Y, Richter I, Barbanti M, Valvo R, De Backer O, Ooms JF, Islas F, Marroquin L, Sedaghat A, Sugiura A, Masiero G, Armario X, Fiorina C, Arzamendi D, Santos-Martinez S, Fernández-Vázquez F, Baz JA, Steblovnik K, Mauri V, Adam M, Merdler I, Hein M, Ruile P, Codner P, Grasso C, Branca L, Estévez-Loureiro R, Benito-González T, Amat-Santos IJ, Mylotte D, Bunc M, Tarantini G, Nombela-Franco L, Søndergaard L, Van Mieghem NM, Finkelstein A, and Kornowski R
- Subjects
- Aged, 80 and over, Aortic Valve diagnostic imaging, Aortic Valve surgery, Humans, Prosthesis Design, Registries, Risk Factors, Treatment Outcome, Aortic Valve Insufficiency diagnostic imaging, Aortic Valve Insufficiency etiology, Aortic Valve Insufficiency surgery, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Heart Valve Prosthesis, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement methods
- Abstract
Background: Data on outcomes of transcatheter aortic valve replacement (TAVR) using balloon-expandable valves (BEVs) or self-expandable valves (SEVs) as well as the impact of center valve preference on these outcomes are limited., Objectives: The aim of this study was to compare outcomes of TAVR procedures using third-generation BEVs and SEVs stratified by center valve preference., Methods: In a multicenter registry (n = 17), 13 centers exhibited valve preference (66.6%-90% of volume) and were included. Outcomes were compared between BEVs and SEVs stratified by center valve preference., Results: In total, 7,528 TAVR procedures (3,854 with SEVs and 3,674 with BEVs) were included. The mean age was 81 years, and the mean Society of Thoracic Surgeons score was 5.2. Baseline characteristics were similar between BEVs and SEVs. Need for pacemaker implantation was higher with SEVs at BEV- and SEV-dominant centers (17.8% vs 9.3% [P < 0.001] and 12.7% vs 10.0% [P = 0.036], respectively; HR: 1.51; P for interaction = 0.021), risk for cerebrovascular accident was higher with SEVs at BEV-dominant but not SEV-dominant centers (3.6% vs 1.1% [P < 0.001] and 2.2% vs 1.4% [P = 0.162]; HR: 2.08; P for interaction < 0.01). Aortic regurgitation greater than mild was more frequent with SEVs at BEV-dominant centers and similar with BEVs regardless of center dominance (5.2% vs 2.8% [P < 0.001] and 3.4% vs 3.7% [P = 0.504], respectively). Two-year mortality was higher with SEVs at BEV-dominant centers but not at SEV-dominant centers (21.9% vs 16.9% [P = 0.021] and 16.8% vs 16.5% [P = 0.642], respectively; HR: 1.20; P for interaction = 0.032)., Conclusions: Periprocedural outcomes, aortic regurgitation greater than mild, and 2-year mortality are worse when TAVR is performed using SEVs at BEV-dominant centers. Outcomes are similar regardless of valve type at SEV-dominant centers. The present results stress the need to account for this factor when comparing BEV and SEV outcomes. (The Aortic+Mitral Transcatheter [AMTRAC] Valve Registry; NCT04031274)., Competing Interests: Funding Support and Author Disclosures Dr Van Miegham has received research grant support from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, PulseCath BV, and Daiichi-Sankyo; and has received advisory fees from Abbott, Boston Scientific, Ancora, Medtronic, PulseCath BV, and Daiichi-Sankyo. Dr Barbanti has received consulting fees from Edwards Lifesciences. Dr Grasso is a proctor for Abbott Vascular. Dr De Backer has received research grants and consulting fees from Abbott and Boston Scientific. Dr Andreas is a proctor for Abbott and Edwards Lifesciences; and has received advisory board fees from Medtronic. Dr Estévez-Loureiro is a consultant for Abbott Vascular and Boston Scientific. Dr Nombela-Franco has received consulting fees from Edwards Lifesciences; and is a proctor for Abbott. Dr Søndergaard has received consulting fees and/or institutional research support from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and SMT. Dr Amat-Santos is a proctor for Boston Scientific. Dr Finkelstein is a proctor for Edwards Lifesciences and Medtronic; and has received consulting fees from Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2022
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40. Association of socioeconomic status measures with physical activity and subsequent frailty in older adults.
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Kheifets M, Goshen A, Goldbourt U, Witberg G, Eisen A, Kornowski R, and Gerber Y
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- Aged, Exercise, Female, Frail Elderly, Humans, Male, Residence Characteristics, Social Class, Socioeconomic Factors, Frailty diagnosis, Frailty epidemiology
- Abstract
Background: Despite increased recognition, frailty remains a significant public health challenge., Objective: we aimed to assess the role of education and income, as well as neighborhood socioeconomic status, on physical activity and subsequent frailty in older adults., Methods: Using a population-based cohort of older adults, this study examined the relationship between socioeconomic status (SES) factors, physical activity and frailty. The study included 1,799 participants (mean [SD], 74.6 (6.2), 53.3% female) from the "National Health and Nutrition Survey of Older Adults Aged 65 and Over in Israel", conducted in 2005-2006. A follow-up interview was performed 12-14 years later in a subgroup of 601 subjects (mean [SD], age 84[4]; 56% women). Self-reported leisure-time physical activity (LTPA) was measured at both baseline and follow-up. SES measures were assessed at baseline. Frailty was measured at follow-up, using the Fried's Phenotype Model., Results: All SES measures were strongly and positively associated with LTPA (all p < 0.001). Eighty-two participants (14%) were classified as frail at follow-up. After age and sex adjustment and accounting for attrition bias using inverse probability weighting, baseline LTPA (OR = 2.77, 95% CI: 1.57-4.90, for inactivity; OR = 1.41, 95% CI: 0.75-2.68, for insufficient activity, compared with sufficient activity, P
trend < 0.001) was inversely associated with incident frailty. The association persisted after further adjustment for SES and comorbidity., Conclusion: Among older individuals, multiple SES measures were positively associated with LTPA, which was a strong predictor of lower subsequent frailty risk., (© 2022. The Author(s).)- Published
- 2022
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41. Tricuspid Structural Valve Deterioration Treated with a Transcatheter Valve-in-Valve Implantation: A Single-Center Prospective Registry.
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Schamroth Pravda N, Vaknin Assa H, Levi A, Witberg G, Shapira Y, Vaturi M, Orvin K, Talmor Barkan Y, Hamdan A, Mishaev R, Sharoni R, Perl L, Sagie A, Kornowski R, and Codner P
- Abstract
The valve-in-valve (ViV) technique is an emerging alternative for the treatment of bioprosthetic structural valve deterioration (SVD) in the tricuspid position. We report on the outcomes of patients treated by a transcatheter tricuspid valve-in-valve (TT-ViV) implantation for symptomatic SVD in the tricuspid position during the years 2010-2019 at our center. Three main outcomes were examined during the follow-up period: TT-ViV hemodynamic data per echocardiography, mortality and NYHA functional class. Our cohort consisted of 12 patients with a mean age 65.4 ± 11.9 years, 83.3% male. The mean time from initial valve intervention to TT-ViV was 17.4 ± 8.7 years. The indications for TT-ViV were varied (41.7% for predominant regurgitation, 33.3% for predominant stenosis and 25.0% with a mixed pathology). All patients were treated with a balloon-expandable device. The mean follow-up was 3.4 ± 1.3 years. Tricuspid regurgitation was ≥ moderate in 57.2% of patients prior to the procedure and this decreased to 0% following the procedure. The mean transtricuspid valve gradients mildly decreased from the mean pre-procedural values of 9.0 mmHg to 7.0 mmHg at one month following the procedure ( p = 0.36). Mortality at one year was 8.0% (95% CI 0-23). At the baseline, 4 patients (33.3%) were in NYHA functional class III/IV; this was reduced to 2 patients (18.2%) at the one year follow-up and both were in NYHA III. The TT-ViV procedure offered a safe, feasible and less invasive treatment option for patients with SVD in our detailed cohort.
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- 2022
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42. Five-Year Outcomes of Patients With Mitral Structural Valve Deterioration Treated With Transcatheter Valve in Valve Implantation - A Single Center Prospective Registry.
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Schamroth Pravda N, Mishaev R, Levi A, Witberg G, Shapira Y, Orvin K, Barkan YT, Hamdan A, Sharoni R, Perl L, Sagie A, Assa HV, Kornowski R, and Codner P
- Abstract
The Valve-in-Valve (ViV) technique is an emerging alternative for the treatment of bioprosthetic structural valve deterioration (SVD) in the mitral position. We report on intermediate-term outcomes of patients with symptomatic SVD in the mitral position who were treated by transcatheter mitral valve-in-valve (TM-ViV) implantation during the years 2010-2019 in our center. Three main outcomes were examined during the follow-up period: NYHA functional class, TM-ViV hemodynamic data per echocardiography, and mortality. Our cohort consisted of 49 patients (mean age 77.4 ± 10.5 years, 65.3% female). The indications for TM-ViV were mainly for regurgitant pathology (77.6%). All 49 patients were treated with a balloon-expandable device. The procedure was performed via transapical access in 17 cases (34.7%) and transfemoral vein/trans-atrial septal puncture in 32 cases (65.3%). Mean follow-up was 4.4 ± 2.0 years. 98% and 91% of patients were in NYHA I/II at 1 and 5 years, respectively. Mitral regurgitation was ≥moderate in 86.3% of patients prior to the procedure and this decreased to 0% ( p < 0.001) following the procedure and was maintained over 2 years follow-up. The mean trans-mitral valve gradients decreased from pre-procedural values of 10.1 ± 5.1 mmHg to 7.0 ± 2.4 mmHg at 1 month following the procedure ( p = 0.03). Mortality at 1 year was 16% (95%, CI 5-26) and 35% (95%, CI 18-49) at 5 years. ViV in the mitral position offers an effective and durable treatment option for patients with SVD at high surgical risk., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Schamroth Pravda, Mishaev, Levi, Witberg, Shapira, Orvin, Barkan, Hamdan, Sharoni, Perl, Sagie, Assa, Kornowski and Codner.)
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- 2022
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43. Clinical outcomes of transcatheter aortic valve implantation in patients younger than 70 years rejected for surgery: the AMTRAC registry.
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Witberg G, Landes U, Codner P, Barbanti M, Valvo R, De Backer O, Ooms JF, McInerney A, Masiero G, Werner P, Armario X, Fiorina C, Arzamendi D, Santos-Martinez S, Baz JA, Steblovnik K, Mauri V, Adam M, Merdler I, Hein M, Ruile P, Russo M, Musumeci F, Sedaghat A, Sugiura A, Grasso C, Branca L, Estévez-Loureiro R, Amat-Santos IJ, Mylotte D, Andreas M, Bunc M, Tarantini G, Nombela-Franco L, Søndergaard L, Van Mieghem NM, Finkelstein A, and Kornowski R
- Subjects
- Aged, Aortic Valve surgery, Humans, Male, Middle Aged, Registries, Risk Factors, Treatment Outcome, Aortic Valve Stenosis surgery, Heart Valve Prosthesis Implantation methods, Transcatheter Aortic Valve Replacement adverse effects
- Abstract
Background: The mean age of transcatheter aortic valve implantation (TAVI) patients is steadily decreasing., Aims: The aim of the study was to describe the characteristics, the indications for and the outcomes of TAVI in patients <70 years old., Methods: All patients undergoing TAVI (n=8,626) from the 18 participating centres between January 2007 and June 2020 were stratified by age (>70). For patients <70, the indications for TAVI were extracted from Heart Team discussions and the baseline characteristics and mortality were compared between the two groups., Results: Overall, 640 (7.4%) patients were <70 (9.1% during 2018-2020, p<0.001); the mean age was 65.0±2.3 years. The younger patients were more often male, with bicuspid valves or needing valve-in-valve procedures. They had a higher prevalence of lung disease and diabetes. In 80.7% of cases, the Heart Team estimated an increased surgical risk and TAVI was selected, reflected by an STS score >4% in 20.4%. Five-year mortality was similar (29.4 vs 29.8%, HR 0.95, p=0.432) in the <70 and >70 groups. In the <70 group, mortality was higher for those referred for TAVI due to an increased surgical risk compared to those referred for other reasons (31.6 vs 24.5%, HR 1.23, p=0.021). Mortality was similar regardless of the STS stratum in patients judged by the Heart Team to be at increased surgical risk (32.6 vs 30.4%, HR 0.98, p=0.715)., Conclusions: Use of TAVI in patients <70 is becoming more frequent. The main reason for choosing TAVI is due to an increased surgical risk not adequately represented by the STS score. The outcomes for these patients are similar to those for older TAVI patients. Dedicated trials of TAVI/SAVR in younger patients are needed to guide decisions concerning expansion of TAVI indications. ((ClinicalTrials.gov: NCT04031274).
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- 2022
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44. A Case Series of Myocarditis Following Third (Booster) Dose of COVID-19 Vaccination: Magnetic Resonance Imaging Study.
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Shiyovich A, Witberg G, Aviv Y, Kornowski R, and Hamdan A
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Background: Myocarditis has been reported following the first two doses of Pfizer-BNT162b2 messenger RNA (mRNA) COVID-19 vaccination. Administration of a third dose (booster) of the vaccine was initiated recently in Israel., Objective: The aim of this study was to describe the characteristics of patients referred for cardiac magnetic resonance (CMR) imaging with myocarditis following the booster., Methods: Patients referred for CMR imaging with a clinical diagnosis of myocarditis within 21 days following the booster, between July 13 and November 11, 2021, were analyzed., Results: Overall, 4 patients were included, 3/4 (75%) were men, and the mean age was 27 ± 10 years. The time from booster administration to the onset of symptoms was 5.75 ± 4.8 days (range 2-14). Obstructive coronary artery disease was excluded in 3 of the patients (75%). CMR was performed 34 ± 15 days (range 8-47 days) following the 3rd vaccination. The mean left ventricular ejection fraction was 61 ± 7% (range 53-71%), and regional wall motion abnormalities were present in one of the patients. Global T1 was increased in one of the patients, while focal T1 values were increased in 3 of the patients. Global T2 was increased in one of the patients, while focal T2 values were increased in all the patients. Global ECV was increased in 3 of the patients, while focal ECV was increased in all the patients. Median late gadolinium enhancement (LGE) was 4 ± 3% (range 1-9%), with the inferolateral segment as the most common location (3 of the 4 patients). All the patients met the Updated Lake Louise Criteria., Conclusions: Patient characteristics and CMR imaging findings of myocarditis following the administration of the booster vaccine are relatively mild and consistent with those observed with the first two doses. Although larger-scale prospective studies are necessary, these initial findings are somewhat reassuring., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Shiyovich, Witberg, Aviv, Kornowski and Hamdan.)
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- 2022
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45. Biodegradable polymer drug-eluting stents versus durable polymer drug-eluting stents for percutaneous coronary intervention: a contemporary registry-based analysis.
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Levi A, Kheifets M, Bental T, Perl L, Codner P, Witberg G, Talmor-Barkan Y, Landes U, Samara A, Greenberg G, Erez A, Vaknin-Assa H, and Kornowski R
- Subjects
- Absorbable Implants statistics & numerical data, Aged, Drug-Eluting Stents standards, Durable Medical Equipment statistics & numerical data, Female, Humans, Male, Middle Aged, Percutaneous Coronary Intervention methods, Percutaneous Coronary Intervention statistics & numerical data, Propensity Score, Registries statistics & numerical data, Treatment Outcome, Absorbable Implants standards, Drug-Eluting Stents statistics & numerical data, Durable Medical Equipment standards
- Abstract
Aims: We aimed to compare the long-term outcomes of patients undergoing percutaneous coronary intervention (PCI) with biodegradable polymer drug-eluting stents (BP-DES) versus durable polymer drug-eluting stents (DP-DES)., Methods and Results: Among 11 517 PCIs with second-generation DES performed in our institution between 2007 and 2019, we identified 8042 procedures performed using DP-DES and 3475 using BP-DES. The primary outcome was target lesion failure, the composite target lesion revascularization (TLR), target vessel myocardial infarction and death. Propensity score matching was used to create a well-balanced cohort. Mean follow-up was 4.8 years. Of the 3413 matched pairs, 21% were females, and the mean age was 66 years. At 1 year, the primary outcome occurred in 8.3% patients versus 7.1% (P = 0.07), and TLR rate was 3% versus 2% (P = 0.006) in patients with DP-DES and BP-DES respectively. Within 5 years, the primary outcome occurred in 23.1% versus 23.4% (P = 0.44), and the rate of TLR was 7.2% versus 6.5% (P = 0.07) in patients with DP-DES and BP-DES, respectively., Conclusion: Similar rates of the composite outcome were observed throughout the entire follow-up. Target lesion revascularization rates were lower in the BP-DES group at 1-year but equalized within 5 years., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2022
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46. Acute myocarditis caused by COVID-19 disease and following COVID-19 vaccination.
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Kornowski R and Witberg G
- Subjects
- COVID-19 Vaccines adverse effects, Humans, Male, SARS-CoV-2, United States, Vaccination adverse effects, COVID-19 diagnosis, COVID-19 prevention & control, Myocarditis complications, Myocarditis etiology
- Abstract
Myocarditis and pericarditis are inflammatory conditions of the heart that present a range of symptoms, often including chest pain, fatigue, breathlessness and palpitations that may be irregular due to cardiac rhythm disturbances. Myocarditis has been proposed to account for a fraction of cardiac injury among patients infected with SARS-CoV-2 and associated systemic inflammation; and it might be one of the reasons for the high mortality seen in COVID-19 patients. Furthermore, following vaccination with mRNA COVID-19 vaccines (ie, Comirnaty and Spikevax), myocarditis and pericarditis can develop within a few days of vaccination, particularly following the second dose. Based on recent reviewed data, the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have determined that the risk for both of these conditions is overall 'very rare' (~1 in 10 000 vaccinated people may be clinically affected), with the highest risk among younger males. Both EMA and FDA agree that the benefits of all authorised COVID-19 vaccines continue to outweigh their risks, given the threat of serious COVID-19 illness and related complications. Since myocarditis has a very wide clinical spectrum, ranging from mild to fulminant life-threatening disease, we present in this review a sum of the latest findings and considerations for the proper diagnosis and management of affected patients., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2022
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47. Mechanical vs Bioprosthetic Aortic Valve Replacement in Patients Younger Than 70 Years of Age: A Hazard Ratio Meta-analysis.
- Author
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Leviner DB, Witberg G, Levi A, Landes U, Schwartz N, Shiran A, Kornowski R, and Sharoni E
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- Aortic Valve Disease surgery, Humans, Middle Aged, Mortality, Aortic Valve surgery, Bioprosthesis adverse effects, Heart Valve Prosthesis adverse effects, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation methods, Long Term Adverse Effects etiology, Long Term Adverse Effects mortality, Postoperative Complications classification, Postoperative Complications epidemiology, Postoperative Complications etiology, Postoperative Complications surgery, Reoperation statistics & numerical data
- Abstract
Background: The choice between mechanical valves (MVs) and bioprosthetic valves (BVs) in patients undergoing aortic valve surgery is complex, requiring a balance between the inferior durability of BV and the indicated long-term anticoagulation therapy with MV. This is especially challenging in the middle age group (< 70 years), which has seen an increased use of BV over recent years., Methods: A meta-analysis of randomised controlled trials (RCTs), observational studies using propensity score matching (PSM) and inverse probability weighting (IPW) was conducted to examine the clinical outcomes of patients < 70 years of age undergoing aortic valve replacement. The primary outcome was overall long-term mortality. Secondary outcomes included bleeding events, reoperation, systemic thromboembolism, and cerebrovascular accident., Results: Fifteen studies (1 RCT, 12 PSM studies, and 2 IPW studies; aggregated sample size 16,876 patients) were included. Median follow-up was 7.8 years. Mortality was higher with BVs vs MVs (hazard ratio [HR] 1.22, 95% confidence interval [CI] 1.00-1.49), as was reoperation (HR 3.05, 95% CI 2.22-4.19). Bleeding risk was lower with BVs (HR 0.58, 95% CI 0.48-0.69), and the risk of stroke was similar in both valve types (HR 0.96, 95% CI 0.83-1.11) CONCLUSIONS: This broadest meta-analysis comparing BV and MV suggests a survival benefit for MVs in patients < 70 years of age. This should lead to reassessment of current patterns used in the choice of valves for patients < 70 among the cardiothoracic surgery community., (Copyright © 2021 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)
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- 2022
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48. Clinical Outcomes of FFRangio-Guided Treatment for Coronary Artery Disease.
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Witberg G, Bental T, Levi A, Talmor-Barkan Y, Rotholz A, Tanigaki T, Nakayama M, Omori H, Itakura R, Kawase Y, Matsuo H, and Kornowski R
- Subjects
- Coronary Angiography, Coronary Vessels, Humans, Treatment Outcome, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease therapy, Fractional Flow Reserve, Myocardial, Percutaneous Coronary Intervention adverse effects
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- 2022
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49. Myocarditis after Covid-19 Vaccination in a Large Health Care Organization.
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Witberg G, Barda N, Hoss S, Richter I, Wiessman M, Aviv Y, Grinberg T, Auster O, Dagan N, Balicer RD, and Kornowski R
- Subjects
- Adolescent, Adult, Age Distribution, Comorbidity, Delivery of Health Care, Echocardiography, Female, Hospitalization statistics & numerical data, Humans, Incidence, Israel epidemiology, Kaplan-Meier Estimate, Male, Middle Aged, Myocarditis epidemiology, Patient Acuity, Retrospective Studies, Sex Distribution, Ventricular Dysfunction, Left epidemiology, Ventricular Dysfunction, Left etiology, Young Adult, BNT162 Vaccine adverse effects, COVID-19 prevention & control, Myocarditis etiology
- Abstract
Background: Reports have suggested an association between the development of myocarditis and the receipt of messenger RNA (mRNA) vaccines against coronavirus disease 2019 (Covid-19), but the frequency and severity of myocarditis after vaccination have not been extensively explored., Methods: We searched the database of Clalit Health Services, the largest health care organization (HCO) in Israel, for diagnoses of myocarditis in patients who had received at least one dose of the BNT162b2 mRNA vaccine (Pfizer-BioNTech). The diagnosis of myocarditis was adjudicated by cardiologists using the case definition used by the Centers for Disease Control and Prevention. We abstracted the presentation, clinical course, and outcome from the patient's electronic health record. We performed a Kaplan-Meier analysis of the incidence of myocarditis up to 42 days after the first vaccine dose., Results: Among more than 2.5 million vaccinated HCO members who were 16 years of age or older, 54 cases met the criteria for myocarditis. The estimated incidence per 100,000 persons who had received at least one dose of vaccine was 2.13 cases (95% confidence interval [CI], 1.56 to 2.70). The highest incidence of myocarditis (10.69 cases per 100,000 persons; 95% CI, 6.93 to 14.46) was reported in male patients between the ages of 16 and 29 years. A total of 76% of cases of myocarditis were described as mild and 22% as intermediate; 1 case was associated with cardiogenic shock. After a median follow-up of 83 days after the onset of myocarditis, 1 patient had been readmitted to the hospital, and 1 had died of an unknown cause after discharge. Of 14 patients who had left ventricular dysfunction on echocardiography during admission, 10 still had such dysfunction at the time of hospital discharge. Of these patients, 5 underwent subsequent testing that revealed normal heart function., Conclusions: Among patients in a large Israeli health care system who had received at least one dose of the BNT162b2 mRNA vaccine, the estimated incidence of myocarditis was 2.13 cases per 100,000 persons; the highest incidence was among male patients between the ages of 16 and 29 years. Most cases of myocarditis were mild or moderate in severity. (Funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.)., (Copyright © 2021 Massachusetts Medical Society.)
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- 2021
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50. A meta-analysis of randomized controlled trials comparing percutaneous coronary intervention with optimal medical therapy in stable obstructive coronary artery disease.
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Lerman TT, Witberg G, and Kornowski R
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- Coronary Artery Disease epidemiology, Coronary Artery Disease therapy, Humans, Pulmonary Disease, Chronic Obstructive epidemiology, Randomized Controlled Trials as Topic statistics & numerical data, Coronary Artery Disease classification, Percutaneous Coronary Intervention methods, Pulmonary Disease, Chronic Obstructive therapy
- Abstract
Background: The optimal treatment for patients suffering from stable obstructive coronary artery disease (SOCAD) is controversial. Many studies have examined the value of performing percutaneous coronary intervention (PCI) in these patients but so far no study has been able to demonstrate an improvement in outcomes by performing PCI in addition to optimal medical therapy (OMT). This study aimed to examine the added value of performing PCI plus OMT vs. OMT alone regarding cardiovascular outcomes., Methods and Results: We performed a systematic search and a meta-analysis for randomized controlled trials comparing PCI plus OMT vs. OMT in SOCAD patients. We included six trials (N = 11 144) with follow-up ranges 2.2-11.4 years. The pooled analysis showed no significant difference between PCI + OMT vs. OMT group regarding all-cause mortality, odds ratio (OR) = 0.98 [confidence interval (CI) 0.86-1.12, P = 0.79, I2 = 0%]. In addition, we have found no difference between the two groups regarding cardiovascular mortality, OR = 0.91 (CI 0.76-1.08, P = 0.27, I2 = 24%). Moreover, there was no difference in the incidence of myocardial infarction, OR = 0.92 (CI 0.81-1.04, P = 0.18, I2 = 49%)., Conclusion: Our results suggest that there is no improvement in cardiovascular outcomes of patients with SOCAD by performing PCI plus OMT vs. OMT alone. This study provides an insight that should be taken under consideration in the management of SOCAD patients., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)
- Published
- 2021
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