30 results on '"Shahim B"'
Search Results
2. Coronary angiography and intervention after transcatheter aortic valve implantation (TAVI): the nationwide SWEDEHEART registry
- Author
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Nilsson, K, primary, Shahim, B, additional, Settergren, M, additional, and James, S, additional
- Published
- 2023
- Full Text
- View/download PDF
3. Management of dyslipidaemia in patients with coronary heart disease: Results from the ESC-EORP EUROASPIRE V survey in 27 countries
- Author
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De Backer, Guy Jankowski, Piotr Kotseva, Kornelia and Mirrakhimov, Erkin Reiner, Zeljko Ryden, Lars Tokgozoglu, Lale Wood, David De Bacquer, Dirk Abreu, A. Aguiar, C. and Badariene, J. Bruthans, J. Castro Conde, A. Cifkova, R. and Crowley, J. Davletov, K. De Smedt, D. De Sutter, J. and Deckers, J. W. Dilic, M. Dolzhenko, M. Druais, H. and Dzerve, V. Erglis, A. Fras, Z. Gaita, D. Gotcheva, N. and Grobbee, D. E. Gyberg, V. Ali, H. Hasan Heuschmann, P. and Hoes, A. W. Lalic, N. Lehto, S. Lovic, D. Maggioni, A. P. Mancas, S. Marques-Vidal, P. Mellbin, L. Milicic, D. Oganov, R. Pogosova, N. Stagmo, M. Stoerk, S. and Sundvall, J. Tsioufis, K. Vulic, D. Wood, D. A. and Jennings, C. Adamska, A. Adamska, S. Mellbin, L. and Tuomilehto, J. Schnell, O. Fiorucci, E. Glemot, M. and Larras, F. Missiamenou, V. Maggioni, A. Taylor, C. and Ferreira, T. Lemaitre, K. Raman, L. Sundvall, J. and DeSmedt, D. De Sutter, J. Willems, A. M. De Pauw, M. and Vervaet, P. Bollen, J. Dekimpe, E. Mommen, N. Van Genechten, G. Dendale, P. Bouvier, C. A. Chenu, P. and Huyberechts, D. Persu, A. Dilic, M. Begic, A. Nalbantic, A. Durak Dzubur, A. Hadzibegic, N. Iglica, A. Kapidjic, S. Bico, A. Osmanagic Resic, N. Bajramovic, N. Sabanovic and Zvizdic, F. Vulic, D. Kovacevic-Preradovic, T. and Popovic-Pejicic, S. Djekic, D. Gnjatic, T. Knezevic, T. and Kovacevic-Preradovic, T. Kos, Lj Popovic-Pejicic, S. and Stanetic, B. Topic, G. Gotcheva, N. Georgiev, Borislav and Terziev, A. Vladimirov, G. Angelov, A. Kanazirev, B. and Nikolaeva, S. Tonkova, D. Vetkova, M. Milicic, D. and Bosnic, A. Dubravcic, M. Glavina, M. Mance, M. and Pavasovic, S. Samardzic, J. Batinic, T. Crljenko, K. and Delic-Brkljacic, D. Dula, K. Golubic, K. Klobucar, I. and Kordic, K. Kos, N. Nedic, M. Olujic, D. Sedinic, V. and Blazevic, T. Pasalic, A. Percic, M. Sikic, J. Bruthans, J. Cifkova, R. Hasplova, K. Sulc, P. Wohlfahrt, P. and Mayer, Jr., O. Cvicela, M. Filipovsky, J. Gelzinsky, J. and Hronova, M. Hasan-Ali, H. Bakery, S. Mosad, E. Hamed, H. B. Ibrahim, A. Elsharef, M. A. Kholef, E. F. Shehata, A. and Youssef, M. Elhefny, E. Farid, H. Moustafa, T. M. and Sobieh, M. S. Kabil, H. Abdelmordy, A. Lehto, S. and Kiljander, E. Kiljander, P. Koukkunen, H. Mustonen, J. and Cremer, C. Frantz, S. Haupt, A. Hofmann, U. Ludwig, K. and Melnyk, H. Noutsias, M. Karmann, W. Prondzinsky, R. and Herdeg, C. Hoevelborn, T. Daaboul, A. Geisler, T. and Keller, T. Sauerbrunn, D. Walz-Ayed, M. Ertl, G. Leyh, R. Stoerk, S. Heuschmann, P. Ehlert, T. Klocke, B. and Krapp, J. Ludwig, T. Kaes, J. Starke, C. Ungethuem, K. and Wagner, M. Wiedmann, S. Tsioufis, K. Tolis, P. and Vogiatzi, G. Sanidas, E. Tsakalis, K. Kanakakis, J. and Koutsoukis, A. Vasileiadis, K. Zarifis, J. Karvounis, C. and Crowley, J. Gibson, I. Houlihan, A. Kelly, C. O'Donnell, M. Bennati, M. Cosmi, F. Mariottoni, B. Morganti, M. and Cherubini, A. Di Lenarda, A. Radini, D. Ramani, F. and Francese, M. G. Gulizia, M. M. Pericone, D. Davletov, K. and Aigerim, K. Bekbolat, Z. Amirov, B. Assembekov, B. and Chernokurova, E. Ibragimova, F. Kodasbayev, A. Markova, A. and Asanbaev, A. Toktomamatov, U. Tursunbaev, M. Zakirov, U. and Abilova, S. Arapova, R. Bektasheva, E. Esenbekova, J. and Neronova, K. Asanbaev, A. Baigaziev, K. Toktomamatov, U. and Zakirov, U. Baitova, G. Zheenbekov, T. Erglis, A. and Andrejeva, T. Bajare, I. Kucika, G. Labuce, A. Putane, L. Stabulniece, M. Dzerve, V. Klavins, E. Sime, I. and Badariene, J. Gedvilaite, L. Peciuraite, D. Sileikiene, V. and Skiauteryte, E. Solovjova, S. Sidabraite, R. Briedis, K. and Ceponiene, I. Jurenas, M. Kersulis, J. Martinkute, G. and Vaitiekiene, A. Vasiljevaite, K. Veisaite, R. Plisiene, J. Siurkaite, V. Vaiciulis, Z. Czarnecka, D. Koziel, P. and Podolec, P. Nessler, J. Gomula, P. Mirek-Bryniarska, E. and Bogacki, P. Wisniewski, A. Pajak, A. Wolfshaut-Wolak, R. and Bucko, J. Kaminski, K. Lapinska, M. Paniczko, M. and Raczkowski, A. Sawicka, E. Stachurska, Z. Szpakowicz, M. and Musial, W. Dobrzycki, S. Bychowski, J. Kosior, D. A. and Krzykwa, A. Setny, M. Kosior, D. A. Rak, A. Gasior, Z. and Haberka, M. Gasior, Z. Haberka, M. Szostak-Janiak, K. and Finik, M. Liszka, J. Botelho, A. Cachulo, M. Sousa, J. Pais, A. Aguiar, C. Durazzo, A. Matos, D. and Gouveia, R. Rodrigues, G. Strong, C. Guerreiro, R. and Aguiar, J. Abreu, A. Cruz, M. Daniel, P. Morais, L. and Moreira, R. Rosa, S. Rodrigues, I. Selas, M. Gaita, D. and Mancas, S. Apostu, A. Cosor, O. Gaita, L. Giurgiu, L. Hudrea, C. Maximov, D. Moldovan, B. Mosteoru, S. and Pleava, R. Ionescu, M. Parepa, I. Pogosova, N. and Arutyunov, A. Ausheva, A. Isakova, S. Karpova, A. and Salbieva, A. Sokolova, O. Vasilevsky, A. Pozdnyakov, Y. and Antropova, O. Borisova, L. Osipova, I. Lovic, D. and Aleksic, M. Crnokrak, B. Djokic, J. Hinic, S. Vukasin, T. Zdravkovic, M. Lalic, N. M. Jotic, A. Lalic, K. and Lukic, L. Milicic, T. Macesic, M. Gajovic, J. Stanarcic and Stoiljkovic, M. Djordjevic, D. Kostic, S. Tasic, I. and Vukovic, A. Fras, Z. Jug, B. Juhant, A. Krt, A. and Kugonjic, U. Chipayo Gonzales, D. Gomez Barrado, J. J. and Kounka, Z. Marcos Gomez, G. Mogollon Jimenez, M. V. Ortiz Cortes, C. Perez Espejo, P. Porras Ramos, Y. Colman, R. and Delgado, J. Otero, E. Perez, A. Fernandez-Olmo, M. R. and Torres-LLergo, J. Vasco, C. Barrenada, E. Botas, J. and Campuzano, R. Gonzalez, Y. Rodrigo, M. de Pablo, C. and Velasco, E. Hernandez, S. Lozano, C. Gonzalez, P. and Castro, A. Dalmau, R. Hernandez, D. Irazusta, F. J. and Velez, A. Vindel, C. Gomez-Doblas, J. J. Garcia Ruiz, V. and Gomez, L. Gomez Garcia, M. Jimenez-Navarro, M. Molina Ramos, A. Marzal, D. Martinez, G. Lavado, R. Vidal, A. and Bostrom-Nilsson, V. Kjellstrom, B. Shahim, B. Smetana, S. and Hansen, O. Stensgaard-Nake, E. Deckers, J. W. Klijn, A. J. Mangus, T. J. P. Peters, R. J. G. Reimer, W. Scholte Op and Snaterse, M. Aydogdu, S. Erol, C. Oturk, S. Kaya, C. Tulunay Ahmetoglu, Y. Ergene, O. Akdeniz, B. Cirgamis, D. Kultursay, S. Akkoyun H. Kayikcioglu, M. Catakoglu, A. B. and Cengel, A. Kocak, A. A. Agirbasli, M. A. Aciksari, G. and Cekin, M. E. Kaya, E. B. Kocyigit, D. Ongen, Z. and Ozmen, E. Sansoy, V. Kaya, A. Oktay, V. Temizhan, A. and Unal, S. Yakut, I. Kalkan, A. K. Bozkurt, E. Kasapkara, H. A. Dolzhenko, M. Faradzh, C. Hrubyak, L. Konoplianyk, L. Kozhuharyova, N. Lobach, L. Nesukai, V. Nudchenko, O. and Simagina, T. Yakovenko, L. Azarenko, V. Potabashny, V. and Bazylevych, A. Bazylevych, M. Kaminska, K. Panchenko, L. and Shershnyova, O. Ovrakh, T. Serik, S. Kolesnik, T. and Kosova, H. Adamska, A. Adamska, S. Jennings, C. Atkin, A. Hoye P. Fellowes, D. Lindsay, S. Atkinson, C. and Kranilla, C. Vinod, M. Beerachee, Y. Bennett, C. Broome, M. Bwalya, A. Caygill, Lindsay Dinning, L. Gillespie, A. and Goodfellow, R. Guy, J. Idress, T. Mills, C. Morgan, C. Oustance, N. Singh, N. Yare, M. Jagoda, J. M. and Bowyer, H. Christenssen, V. Groves, A. Jan, A. Riaz, A. and Gill, M. Sewell, T. A. Gorog, D. Baker, M. De Sousa, P. Mazenenga, T. Porter, J. Haines, F. Peachey, T. and Taaffe, J. Wells, K. Ripley, D. P. Forward, H. McKie, H. and Pick, S. L. Thomas, H. E. Batin, P. D. Exley, D. and Rank, T. Wright, J. Kardos, A. Sutherland, S. -B. Wren, L. Leeson, P. Barker, D. Moreby, B. Sawyer, J. and Stirrup, J. Brunton, M. Brodison, A. Craig, J. Peters, S. Kaprielian, R. Bucaj, A. Mahay, K. Oblak, M. and Gale, C. Pye, M. McGill, Y. Redfearn, H. Fearnley, M. and EUROASPIRE V Collaborators Writing Comm Sci Steering Executive Comm Coordinating Ctr Diabet Ctr Data Management Ctr Stat Anal Ctr Cent Lab Study Ctr Org Investigators Other
- Abstract
Background and aims: One of the objectives of the ESC-EORP EUROASPIRE V survey is to determine how well European guidelines on the management of dyslipidaemias are implemented in coronary patients. Methods: Standardized methods were used by trained technicians to collect information on 7824 patients from 130 centers in 27 countries, from the medical records and at a visit at least 6 months after hospitalization for a coronary event. All lipid measurements were performed in one central laboratory. Patients were divided into three groups: on high-intensity LDL-C-lowering-drug therapy (LLT), on low or moderate-intensity LLT and on no LLT. Results: At the time of the visit, almost half of the patients were on a high-intensity LLT. Between hospital discharge and the visit, LLT had been reduced in intensity or interrupted in 20.8% of the patients and had been started or increased in intensity in 11.7%. In those who had interrupted LLT or had reduced the intensity, intolerance to LLT and the advice of their physician were reported as the reason why in 15.8 and 36.8% of the cases, respectively. LDL-C control was better in those on a high-intensity LLT compared to those on low or moderate intensity LLT. LDL-C control was better in men than women and in patients with self-reported diabetes. Conclusions: The results of the EUROASPIRE V survey show that most coronary patients have a less than optimal management of LDL-C. More professional strategies are needed, aiming at lifestyle changes and LLT adapted to the need of the individual patient.
- Published
- 2019
4. P5085Optimizing outreach strategy to identify individuals at risk for diabetes and/or cardiovascular disease: a study of the Sodertalje municipality in Sweden
- Author
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Shahim, B S, primary, Bolt Christmas, O S, additional, Gyberg, V G, additional, Hasselberg, S H, additional, Mellbin, L M, additional, and Ryden, L R, additional
- Published
- 2018
- Full Text
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5. Cause-specific death in heart failure across the ejection fraction spectrum: A comprehensive assessment of over 100 000 patients in the Swedish Heart Failure Registry.
- Author
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Settergren C, Benson L, Shahim A, Dahlström U, Thorvaldsen T, Savarese G, Lund LH, and Shahim B
- Subjects
- Humans, Female, Male, Sweden epidemiology, Aged, Aged, 80 and over, Heart Failure physiopathology, Heart Failure mortality, Heart Failure epidemiology, Stroke Volume physiology, Registries, Cause of Death trends
- Abstract
Aim: To assess cause-specific death in patients with heart failure with preserved, mildly reduced, and reduced ejection fraction (HFpEF, HFmrEF, and HFrEF)., Methods and Results: Data were analysed from the Swedish Heart Failure Registry (SwedeHF) and the National Patient Register of patients enrolled in SwedeHF 2000-2021. Cox proportional hazards regression models were performed and adjusted for age, sex and time period. Among 100 584 patients (23% HFpEF, 23% HFmrEF, 53% HFrEF), median age (interquartile range) was 75 (66-82) and 36% were female. Of those who died within 5 years, most deaths were ascribed to cardiovascular (CV) causes across all ejection fraction (EF) categories. Within 5 years, HFpEF had higher adjusted risk of non-CV death (hazard ratio [HR] 1.33, 95% confidence interval [CI] 1.28-1.38, p < 0.001) and lower adjusted risk of CV death (HR 0.85, 95% CI 0.82-0.88, p < 0.001) compared to HFrEF. Ischaemic heart disease (IHD) and cancer were the most common causes of CV and non-CV death regardless of EF category. The incidence rate of CV death due to IHD was highest in HFrEF while incidence rates of CV death due to pulmonary vascular disease, stroke, valvular heart disease and atrial fibrillation increased with increasing EF. The incidence rates of non-CV deaths due to cancer, respiratory disease, and infections increased with increasing EF., Conclusion: Cardiovascular death was more common than non-CV death across all EF categories although the risk of non-CV death within 5 years was higher with increasing EF. IHD and cancer were the most common causes of CV and non-CV deaths, respectively, regardless of EF category., (© 2024 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
- Published
- 2024
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6. Epidemiology, Clinical Characteristics and Cause-specific Outcomes in Heart Failure with Preserved Ejection Fraction.
- Author
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Kapelios CJ, Shahim B, Lund LH, and Savarese G
- Abstract
Heart failure (HF) is a global pandemic affecting 64 million people worldwide. HF with preserved ejection fraction (HFpEF) has traditionally received less attention than its main counterpart, HF with reduced ejection fraction (HFrEF). The incidence and prevalence of HFpEF show geographic variation and are increasing over time, soon expected to surpass those of HFrEF. Morbidity and mortality rates of HFpEF are considerable, albeit lower than those of HFrEF. This review focuses on the burden of HFpEF, providing contemporary data on epidemiology, clinical characteristics and comorbidities, cause-specific outcomes, costs and pharmacotherapy., Competing Interests: Disclosure: LHL has received grants from AstraZeneca, Vifor, Boston Scientific, Boehringer Ingelheim, Novartis and MSD; consulting fees from Vifor, AstraZeneca, Bayer, Pharmacosmos, MSD, Medscape, Sanofi, Lexicon, MyoKardia, Boehringer Ingelheim, Servier, Edwards Life Sciences and Alleviant; speaker honoraria from Abbott, Orion Pharma, Medscape, Radcliffe Group, AstraZeneca, Novartis, Boehringer Ingelheim and Bayer; patent and stock for AnaCardio; is a board member of Heart Failure Association of the ESC and Swedish Society of Cardiology, HF Working Group; and is on the Cardiac Failure Review editorial board; this did not influence peer review. GS has received grants from Vifor Pharma, Novartis, Boehringer Ingelheim, Boston Scientific, AstraZeneca, Pharmacosmos, Merck, Bayer, Cytokinetics and Horizon 2022; consulting fees from TEVA, Ministero dell’Istruzione, Università e Ricerca, Medical Education Global Solutions, Atheneum, Genesis, Vifor Pharma and L’Agence nationale de la recherche; honoraria from Servier, Roche, Cytokinetics, Translational Medicine Academy Foundation, Medtronic, Medical Education Global Solutions, Dynamicom Education, AstraZeneca, Vifor Pharma and Novartis; expenses paid by Boehringer Ingelheim; and has participated on the advisory boards of AstraZeneca, Edwards, Uppsala Clinical Research Center (UCR), Vifor and Servier. All other authors have no conflicts of interest to declare., (Copyright © The Author(s), 2023. Published by Radcliffe Group Ltd.)
- Published
- 2023
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7. Reply to 'Aortic regurgitation for adverse cardiovascular events: Really harmless or just hidden?'
- Author
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Shahim A, Shahim B, and Lund LH
- Subjects
- Humans, Heart, Aortic Valve Insufficiency, Heart Failure
- Published
- 2023
- Full Text
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8. Global Public Health Burden of Heart Failure: An Updated Review.
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Shahim B, Kapelios CJ, Savarese G, and Lund LH
- Abstract
Heart failure (HF) is a rapidly growing public health issue with an estimated prevalence of 64 million people globally. Although the incidence of HF has stabilised worldwide and seems to be declining in developed countries, the prevalence is increasing due to the ageing of the population, improved survival after MI and improved treatment and survival of patients with HF. Yet, HF remains associated with high mortality and morbidity, poor quality of life and functional capacity, and confers a substantial burden to the healthcare system. The prevalence, incidence, mortality and morbidity rates reported show geographical variations, depending on the different aetiologies and clinical characteristics observed among patients with HF. In this review, we provide an overview of the global epidemiology of HF with updated data on prevalence, incidence, mortality and morbidity worldwide., Competing Interests: Disclosures: GS has received funding from Vifor Pharma, Boehringer Ingelheim, AstraZeneca, Merck, Cytokinetics, Novartis, Boston Scientific, Pharmacosmos, Bayer and Horizon; consulting fees from Teva, MedEd Global Solutions, Genesis Medical, Agence Nationale de la Recherche, Muir Health, Atheneum and Vifor Pharma; honoraria from Servier, Cytokinetics, Medtronic, Dynamicom Education, Vifor Pharma, Roche, TMA Healthcare Ltd, MedEd Global Solutions, AstraZeneca, Novartis; and has participated on advisory boards for AstraZeneca, Uppsala Clinical Research Center, Servier, Edwards and Vifor Pharma. LHL has received grants from AstraZeneca, Vifor Pharma, Boston Scientific, Boehringer Ingelheim, Novartis; consulting fees from Merck, Vifor Pharma, AstraZeneca, Bayer, Pharmacosmos, MSD, Medscape, Sanofi, Lexicon, Myokardia, Boehringer Ingelheim, Servier, Edwards Life Sciences and Alleviant Medical; speaker’s honoraria from Abbott, Orion Pharma, Medscape, Radcliffe, AstraZeneca, Novartis, Boehringer Ingelheim and Bayer; has stock ownership in AnaCardio; is a board member for the European Society of Cardiology Heart Failure Association and the Swedish Society of Cardiology; and is on the Cardiac Failure Review editorial board; this did not influence peer review. All other authors have no conflicts of interest to declare., (Copyright © The Author(s), 2023. Published by Radcliffe Group Ltd.)
- Published
- 2023
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9. Prevalence, clinical characteristics and outcomes of heart failure patients with or without isolated or combined mitral and tricuspid regurgitation: An analysis from the ESC-HFA Heart Failure Long-Term Registry.
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Adamo M, Chioncel O, Benson L, Shahim B, Crespo-Leiro MG, Anker SD, Coats AJS, Filippatos G, Lainscak M, McDonagh T, Mebazaa A, Piepoli MF, Rosano GMC, Ruschitzka F, Savarese G, Seferovic P, Shahim A, Popescu BA, Iung B, Volterrani M, Maggioni AP, Metra M, and Lund LH
- Subjects
- Humans, Prevalence, Prospective Studies, Stroke Volume, Registries, Treatment Outcome, Retrospective Studies, Tricuspid Valve Insufficiency epidemiology, Tricuspid Valve Insufficiency complications, Heart Failure epidemiology, Heart Failure complications, Mitral Valve Insufficiency epidemiology, Mitral Valve Insufficiency complications, Ventricular Dysfunction, Left complications
- Abstract
Aim: Mitral regurgitation (MR) and tricuspid regurgitation (TR) are common in patients with heart failure (HF). The aim of this study was to investigate prevalence, clinical characteristics and outcomes of patients with or without isolated or combined MR and TR across the entire HF spectrum., Methods and Results: The ESC-HFA EORP HF Long-Term Registry is a prospective, multicentre, observational study including patients with HF and 1-year follow-up data. Outpatients without aortic valve disease were included and stratified according to isolated or combined moderate/severe MR and TR. Among 11 298 patients, 7541 (67%) had no MR/TR, 1931 (17%) isolated MR, 616 (5.5%) isolated TR and 1210 (11%) combined MR/TR. Baseline characteristics were differently distributed across MR/TR categories. Compared to HF with reduced ejection fraction, HF with mildly reduced ejection fraction was associated with a lower risk of isolated MR (odds ratio [OR] 0.69; 95% confidence interval [CI] 0.60-0.80), and distinctly lower risk of combined MR/TR (OR 0.51; 95% CI 0.41-0.62). HF with preserved ejection fraction (HFpEF) was associated with a distinctly lower risk of isolated MR (OR 0.42; 95% CI 0.36-0.49), and combined MR/TR (OR 0.59; 95% 0.50-0.70), but a distinctly increased risk of isolated TR (OR 1.94; 95% CI 1.61-2.33). All-cause death, cardiovascular death, HF hospitalization and combined outcomes occurred more frequently in combined MR/TR, isolated TR and isolated MR versus no MR/TR. The highest incident rates were observed in isolated TR and combined MR/TR., Conclusion: In a large cohort of outpatients with HF, prevalence of isolated and combined MR and TR was relatively high. Isolated TR was driven by HFpEF and was burdened by an unexpectedly poor outcome., (© 2023 European Society of Cardiology.)
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- 2023
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10. Prevalence, characteristics and prognostic impact of aortic valve disease in patients with heart failure and reduced, mildly reduced, and preserved ejection fraction: An analysis of the ESC Heart Failure Long-Term Registry.
- Author
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Shahim B, Shahim A, Adamo M, Chioncel O, Benson L, Crespo-Leiro MG, Anker SD, Coats AJS, Filippatos G, Lainscak M, McDonagh T, Mebazaa A, Piepoli MF, Rosano GMC, Ruschitzka F, Savarese G, Seferovic P, Volterrani M, Crespo Leiro M, Segovia Cubero J, Amir O, Palic B, Maggioni AP, Metra M, and Lund LH
- Subjects
- Humans, Prognosis, Prospective Studies, Prevalence, Stroke Volume, Registries, Ventricular Function, Left, Heart Failure, Ventricular Dysfunction, Left, Aortic Valve Stenosis complications, Aortic Valve Stenosis epidemiology
- Abstract
Aims: To assess the prevalence, clinical characteristics, and outcomes of patients with heart failure (HF) with or without moderate to severe aortic valve disease (AVD) (aortic stenosis [AS], aortic regurgitation [AR], mixed AVD [MAVD])., Methods and Results: Data from the prospective ESC HFA EORP HF Long-Term Registry including both chronic and acute HF were analysed. Of 15 216 patients with HF (62.5% with reduced ejection fraction, HFrEF; 14.0% with mildly reduced ejection fraction, HFmrEF; 23.5% with preserved ejection fraction, HFpEF), 706 patients (4.6%) had AR, 648 (4.3%) AS and 234 (1.5%) MAVD. The prevalence of AS, AR and MAVD was 6%, 8%, and 3% in HFpEF, 6%, 3%, and 2% in HFmrEF and 4%, 3%, and 1% in HFrEF. The strongest associations were observed for age and HFpEF with AS, and for left ventricular end-diastolic diameter with AR. AS (adjusted hazard ratio [HR] 1.43, 95% confidence interval [CI] 1.23-1.67), and MAVD (adjusted HR 1.37, 95% CI 1.07-1.74) but not AR (adjusted HR 1.13, 95% CI 0.96-1.33) were independently associated with the 12-month composite outcome of cardiovascular death and HF hospitalization. The associations between AS and the composite outcome were observed regardless of ejection fraction category., Conclusions: In the ESC HFA EORP HF Long-Term Registry, one in 10 patients with HF had AVD, with AS and MAVD being especially common in HFpEF and AR being similarly distributed across all ejection fraction categories. AS and MAVD, but not AR, were independently associated with increased risk of in-hospital mortality and 12-month composite outcome, regardless of ejection fraction category., (© 2023 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
- Published
- 2023
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11. Minimum Core Data Elements for Transcatheter Mitral Therapies: Scientific Statement by PASSION CV, HVC, and TVTR.
- Author
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Vemulapalli S, Simonato M, Ben Yehuda O, Wu C, Feldman T, Popma JJ, Sundareswaren K, Krohn C, Hardy KM, Guibone K, Christensen B, Alu MC, Ng VG, Chau KH, Chen S, Shahim B, Vincent F, MacMahon J, James S, Mack M, Leon MB, Thourani VH, Carroll J, and Krucoff MW
- Subjects
- Aged, Humans, United States, Treatment Outcome, Catheters, Centers for Medicare and Medicaid Services, U.S., Multicenter Studies as Topic, Medicare, Cardiology
- Abstract
Mitral regurgitation is the most common valvular disease and is estimated to affect over 5 million Americans. Real-world data collection contributes to safety and effectiveness evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, and clinical best practice research. We aimed to establish a minimum core data set in mitral interventions to promote efficient, reusable real-world data collection for all of these purposes. Two expert task forces separately evaluated and reconciled a list of candidate elements derived from: 1) 2 ongoing transcatheter mitral trials; and 2) a systemic literature review of high-impact mitral trials and U.S multicenter, multidevice registries. From 703 unique data elements considered, unanimous consensus agreement was achieved on 127 "core" data elements, with the most common reasons for exclusion from the minimum core data set being burden or difficulty in accurate assessment (41.2%), duplicative information (25.0%), and low likelihood of affecting outcomes (19.6%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established and implemented into the national Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapies Registry 127 interoperable, reusable core data elements to support more efficient, consistent, and informative transcatheter mitral device evidence for regulatory submissions, safety surveillance, best practice development, and hospital quality assessments., Competing Interests: Funding Support and Author Disclosures Dr Vemulapalli has received grants/contracts from the American College of Cardiology, Society of Thoracic Surgeons, National Institutes of Health (R01 and SBIR), Food and Drug Administration (NEST cc), Abbott, Boston Scientific, and Cytokinetics; and is on the advisory board or is a consultant for Edwards Lifesciences, Medtronic, American College of Physicians, and Total CME. Ms Alu has received institutional research funding from Abbott and Edwards Lifesciences. Dr Shahim has received a research grant from the Stockholm county research council. Dr James has been a proctor for Medtronic. Dr Leon has received institutional grants for clinical research from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Thourani has been an advisor for Abbott Vascular, ARtivion, Atricure, Boston Scientific, Edwards Lifesciences, Medtronic, and Shockwave. Dr Carroll has received institutional grants for clinical trials from Edwards Lifesciences, Medtronic, and Abbott; and has been a consultant for Abbott. Dr Krucoff has received grants from Abbott Vascular, Boston Scientific, Medtronic, Mitre Medical, OrbusNeich, and 4C Medical; and has been a consultant for Abbott Vascular, Boston Scientific, Medtronic, Mitre Medical, OrbusNeich, and 4C Medical., (Copyright © 2023 American College of Cardiology Foundation. All rights reserved.)
- Published
- 2023
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12. Impact of Peripheral Artery Disease in Patients With Heart Failure Undergoing Transcatheter Mitral Valve Repair: The COAPT Trial.
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Shahim B, Cohen DJ, Ben-Yehuda O, Redfors B, Kar S, Lim DS, Arnold SV, Li Y, Lindenfeld J, Abraham WT, Mack MJ, and Stone GW
- Subjects
- Humans, Cardiac Catheterization adverse effects, Mitral Valve diagnostic imaging, Mitral Valve surgery, Treatment Outcome, Heart Failure, Heart Valve Prosthesis Implantation methods, Mitral Valve Insufficiency complications, Mitral Valve Insufficiency surgery, Peripheral Arterial Disease
- Abstract
Background Peripheral artery disease (PAD) and heart failure (HF) often coexist. Whether PAD influences outcomes of transcatheter mitral valve repair (TMVr) in patients with HF and severe secondary mitral regurgitation is unknown. The objectives are to assess the impact of PAD on outcomes of TMVr plus guideline-directed medical therapy (GDMT) versus GDMT alone in patients with HF and secondary mitral regurgitation. Methods and Results The COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) randomized patients with HF with ≥moderate-to-severe secondary mitral regurgitation to TMVr with MitraClip implant plus GDMT versus GDMT alone. We evaluated the relationship between PAD and 2-year outcomes in the COAPT trial and examined whether PAD modified the benefits of TMVr. Among 614 patients enrolled, 109 (17.8%) had PAD. By multivariable analysis, PAD was independently associated with 2-year mortality (adjusted hazard ratio [adjHR], 1.51 [95% CI, 1.07-2.15]) but not HF hospitalizations. Compared with GDMT alone, TMVr reduced the 2-year risk of death in patients without PAD (adjHR, 0.42 [95% CI, 0.30-0.60]) but not those with PAD (adjHR, 1.27 [95% CI, 0.72-2.27]; P
interaction =0.001). In contrast, TMVr reduced HF hospitalizations consistently in patients with (adjHR, 0.65 [95% CI, 0.35-1.23]) and without (adjHR, 0.42 [95% CI, 0.31-0.57]) PAD ( Pinteraction =0.22). Improvements in health status and exercise capacity at 2 years with TMVr compared with GDMT alone were similar in degree, irrespective of PAD status ( Pinteraction =0.76 and 0.64, respectively). Conclusions In patients with HF and severe secondary mitral regurgitation, the reduced mortality with TMVr in the overall COAPT study population was not observed in the subgroup of patients with PAD. However, TMVr reduced HF hospitalizations and improved health status and exercise capacity consistently in patients with and without PAD. Registration Clinical Trial Name: Cardiovascular Outocmes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (The COAPT Trial); URL: https://www.clinicaltrials.gov/; Unique identifier: NCT01626079. https://clinicaltrials.gov/ct2/show/NCT01626079.- Published
- 2023
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13. On-Treatment Platelet Reactivity and Ischemic Outcomes in Patients With Diabetes Mellitus: Two-Year Results From ADAPT-DES.
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Shahim B, Redfors B, Stuckey TD, Liu M, Zhou Z, Witzenbichler B, Weisz G, Rinaldi MJ, Neumann FJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Brodie BR, Srdanovic I, Madhavan MV, Mazzaferri EL Jr, Mehran R, Ben-Yehuda O, Kirtane AJ, and Stone GW
- Subjects
- Humans, Platelet Aggregation Inhibitors adverse effects, Prospective Studies, Risk Factors, Blood Platelets, Clopidogrel therapeutic use, Clopidogrel pharmacology, Ischemia etiology, Treatment Outcome, Percutaneous Coronary Intervention adverse effects, Coronary Artery Disease complications, Diabetes Mellitus etiology
- Abstract
Background Diabetes mellitus and high platelet reactivity (HPR) on clopidogrel are both associated with increased risk of ischemic events after percutaneous coronary intervention, but whether the HPR-associated risk of adverse ischemic events differs by diabetes mellitus status is unknown. Methods and Results ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective, multicenter registry of patients treated with coronary drug-eluting stents. HPR was defined as P2Y12 reaction units >208 by the VerifyNow point-of-care assay. Cox multivariable analysis was used to assess whether HPR-associated risk of major adverse cardiac events (MACE; cardiac death, myocardial infarction, or stent thrombosis) varied for patients with insulin-treated diabetes mellitus (ITDM), non-ITDM, and no diabetes mellitus. Diabetes mellitus and HPR were included in an interaction analysis. Of 8582 patients enrolled, 2429 (28.3%) had diabetes mellitus, of whom 998 (41.1%) had ITDM. Mean P2Y12 reaction units were higher in patients with diabetes mellitus versus without diabetes mellitus, and HPR was more frequent in patients with diabetes mellitus. HPR was associated with consistently increased 2-year rates of MACE in patients with and without diabetes mellitus ( P
interaction =0.36). A significant interaction was present between HPR and non-insulin-treated diabetes mellitus versus ITDM for 2-year MACE (adjusted hazard ratio [HR] for non-ITDM, 2.28 [95% CI, 1.39-3.73] versus adjusted HR for ITDM, 1.02 [95% CI, 0.70-1.50]; Pinteraction =0.01). Conclusions HPR was more common in patients with diabetes mellitus and was associated with an increased risk of MACE in both patients with and without diabetes mellitus. In patients with diabetes mellitus, a more pronounced effect of HPR on MACE was present in lower-risk non-ITDM patients than in higher-risk patients with ITDM. Registration URL: https://clinicaltrials.gov/ct2/show/NCT00638794; Unique identifier: NCT00638794. ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents).- Published
- 2023
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14. Neutrophil-to-Lymphocyte Ratios in Patients Undergoing Aortic Valve Replacement: The PARTNER Trials and Registries.
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Shahim B, Redfors B, Lindman BR, Chen S, Dahlen T, Nazif T, Kapadia S, Gertz ZM, Crowley AC, Li D, Thourani VH, Kodali SK, Zajarias A, Babaliaros VC, Guyton RA, Elmariah S, Herrmann HC, Cohen DJ, Mack MJ, Smith CR, Leon MB, and George I
- Subjects
- Aortic Valve surgery, Humans, Lymphocytes, Neutrophils, Registries, Risk Factors, Severity of Illness Index, Treatment Outcome, Aortic Valve Stenosis, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation methods
- Abstract
Background The neutrophil-to-lymphocyte ratio (NLR) as a marker of systemic inflammation has been associated with worse prognosis in several chronic disease states, including heart failure. However, few data exist on the prognostic impact of elevated baseline NLR or change in NLR levels during follow-up in patients undergoing transcatheter or surgical aortic valve replacement (TAVR or SAVR) for aortic stenosis. Methods and Results NLR was available in 5881 patients with severe aortic stenosis receiving TAVR or SAVR in PARTNER (Placement of Aortic Transcatheter Valves) I, II, and S3 trials/registries (median [Q1, Q3] NLR, 3.30 [2.40, 4.90]); mean NLR, 4.10; range, 0.5-24.9) and was evaluated as continuous variable and categorical tertiles (low: NLR ≤2.70, n=1963; intermediate: NLR 2.70-4.20, n=1958; high: NLR ≥4.20, n=1960). No patients had known baseline infection. High baseline NLR was associated with increased risk of death or rehospitalization at 3 years (58.4% versus 41.0%; adjusted hazard ratio [aHR], 1.39; 95% CI, 1.18-1.63; P <0.0001) compared with those with low NLR, irrespective of treatment modality. In both patients treated with TAVR and patients treated with SAVR, NLR decreased between baseline and 2 years. A 1-unit observed decrease in NLR between baseline and 1 year was associated with lower risk of death or rehospitalization between 1 year and 3 years (aHR, 0.86; 95% CI, 0.82-0.89; P <0.0001). Conclusions Elevated baseline NLR was independently associated with increased subsequent mortality and rehospitalization after TAVR or SAVR. The observed decrease in NLR after TAVR or SAVR was associated with improved outcomes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00530894, NCT0134313, NCT02184442, NCT03225001, NCT0322141.
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- 2022
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15. Minimum Core Data Elements for Evaluation of TAVR: A Scientific Statement by PASSION CV, HVC, and TVT Registry.
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Simonato M, Vemulapalli S, Ben-Yehuda O, Wu C, Wood L, Popma J, Feldman T, Krohn C, Hardy KM, Guibone K, Christensen B, Alu MC, Chen S, Ng VG, Chau KH, Shahim B, Vincent F, MacMahon J, James S, Mack M, Leon MB, Thourani VH, Carroll J, and Krucoff M
- Subjects
- Aged, Aortic Valve surgery, Humans, Medicare, Multicenter Studies as Topic, Registries, Risk Factors, Time Factors, Treatment Outcome, United States, Aortic Valve Stenosis diagnosis, Aortic Valve Stenosis surgery, Transcatheter Aortic Valve Replacement
- Abstract
Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, as well as clinical research and real-world implementation through appropriate use criteria. The essential minimum core dataset for these purposes has not previously been defined but is necessary to promote efficient, reusable real-world data collection supporting quality, regulatory, and clinical applications. The authors performed a systematic review of the published research for high-impact TAVR studies and U.S. multicenter, multidevice registries. Two expert task forces, one from the Predictable and Sustainable Implementation of National Cardiovascular Registries/Heart Valve Collaboratory and another from The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry convened separately and then met to reconcile a final list of essential data elements. From 276 unique data elements considered, unanimous consensus agreement was achieved on 132 "core" data elements, with the most common reasons for exclusion from the minimum core dataset being burden or difficulty in accurate assessment (36.9%), duplicative information (33.3%), and low likelihood of affecting outcomes (10.7%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence for regulatory submissions, safety surveillance, best practice, and hospital quality assessments., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2022
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16. Transporting Results of TAVR Trials to the Real World: A Long and Winding Road.
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Shahim B and Cohen DJ
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- Humans, Treatment Outcome, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Heart Valve Prosthesis Implantation, Transcatheter Aortic Valve Replacement adverse effects
- Abstract
Competing Interests: Funding Support and Author Disclosures Dr Cohen has received research grant support and consulting income from Medtronic, Edwards Lifesciences, Abbott, and Boston Scientific. Dr Shahim has reported that she has no relationships relevant to the contents of this paper to disclose.
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- 2021
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17. Sex-Specific Outcomes of Transcatheter Mitral-Valve Repair and Medical Therapy for Mitral Regurgitation in Heart Failure.
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Kosmidou I, Lindenfeld J, Abraham WT, Rinaldi MJ, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Gaba P, Rogers JH, Shahim B, Redfors B, Zhang Z, Mack MJ, and Stone GW
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- Cardiac Catheterization, Female, Humans, Male, Quality of Life, Treatment Outcome, Heart Failure surgery, Heart Failure therapy, Heart Valve Prosthesis Implantation, Mitral Valve Insufficiency surgery
- Abstract
Objectives: This study sought to assess the sex-specific outcomes in patients with heart failure (HF) with 3+ and 4+ secondary mitral regurgitation (SMR) treated with transcatheter mitral valve repair (TMVr) plus guideline-directed medical therapy (GDMT) versus GDMT alone in the COAPT trial., Background: The impact of sex in patients with HF and severe SMR treated with TMVr with the MitraClip compared with GDMT alone is unknown., Methods: Patients were randomized 1:1 to TMVr versus GDMT alone. Two-year outcomes were examined according to sex., Results: Among 614 patients, 221 (36.0%) were women. Women were younger than men and had fewer comorbidities, but reduced quality of life and functional capacity at baseline. In a joint frailty model accounting for the competing risk of death, the 2-year cumulative incidence of the primary endpoint of all HF hospitalizations (HFH) was higher in men compared with women treated with GDMT alone. However, the relative reduction in HFHs with TMVr was greater in men (HR: 0.43; 95% CI: 0.34-0.54) than women (HR: 0.78; 95% CI: 0.57-1.05) (P
interaction = 0.002). A significant interaction between TMVr versus GDMT alone treatment and time was present for all HFHs in women (HR: 0.57; 95% CI: 0.39-0.84, and HR: 1.39; 95% CI: 0.83-2.33 between 0-1 year and 1-2 years after randomization, respectively, Pinteraction = 0.007) but not in men (HR: 0.48; 95% CI: 0.36-0.64, and HR: 0.33; 95% CI: 0.21-0.51; Pinteraction = 0.16). Female sex was independently associated with a lower adjusted risk of death at 2 years (HR: 0.64; 95% CI: 0.46-0.90; P = 0.011). TMVr consistently reduced 2-year mortality compared with GDMT alone, irrespective of sex (Pinteraction = 0.99)., Conclusions: In the COAPT trial, TMVr with the MitraClip resulted in improved clinical outcomes compared with GDMT alone, irrespective of sex. However, the impact of TMVr in reducing HFH was less pronounced in women compared with men beyond the first year after treatment. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Tria] [COAPT]; NCT01626079)., Competing Interests: Funding Support and Author Disclosures The COAPT trial was sponsored by Abbott. Dr Kosmidou has received research grant support from Amgen. Dr Lindenfeld has received research grant support from AstraZeneca; and consulting fees from Abbott Vascular, AstraZeneca, CVRx, Edwards Lifesciences, Impulse Dynamics, Boehringer Ingelheim, VoluMetrix, and V-Wave. Dr Abraham has received research grant support and consulting fees from Abbott Vascular. Dr Rinaldi has received advisory-board fees from Boston Scientific; teaching-course fees from Abbott and Edwards Lifesciences; consulting fees from Abbott, Boston Scientific, and Edwards Lifesciences; research support and grants from Boston Scientific; and proctor fees from Abbott and Edwards Lifesciences. Dr Kapadia holds stock options in Navigate Cardiac Structures, Inc. Dr Rajagopal has received consultant fees from Abbott Vascular; has served on the steering committee for TRILUMINATE study (sponsored by Abbott); screening committee for Medtronic Intrepid; and is founder and CEO of Opus Medical Therapies. Dr Sarembock has served on an advisory board and as a consultant for Boston Scientific. Dr Rogers has received research grant support from Abbott, Boston Scientific, and Edwards Lifesciences; and has served as a consultant for Abbott, Baylis, Boston Scientific, and Gore. Dr Mack has served as co-primary investigator for the PARTNER trial for Edwards Lifesciences and COAPT trial for Abbott and has served as study chair for the APOLLO trial for Medtronic. Dr Stone has received speaker fees or other honoraria from Cook, Terumo, and Orchestra Biomed; has served as consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, Matrizyme, Cardiomech; and has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, MedFocus family of funds, and Valfix. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2021
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18. Impact of Diabetes on Outcomes After Transcatheter Mitral Valve Repair in Heart Failure: COAPT Trial.
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Shahim B, Ben-Yehuda O, Chen S, Redfors B, Madhavan MV, Kar S, Lim DS, Asch FM, Weissman NJ, Cohen DJ, Arnold SV, Liu M, Lindenfeld J, Abraham WT, Mack MJ, and Stone GW
- Subjects
- Cardiac Catheterization, Humans, Mitral Valve surgery, Quality of Life, Treatment Outcome, Diabetes Mellitus epidemiology, Heart Failure complications, Heart Failure therapy, Mitral Valve Insufficiency complications, Mitral Valve Insufficiency surgery
- Abstract
Objectives: This paper sought to determine whether diabetes influences the outcomes of transcatheter mitral valve repair (TMVr) in patients with heart failure (HF) and secondary mitral regurgitation (SMR)., Background: Diabetes is associated with worse outcomes in patients with HF., Methods: The COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With functional Mitral Regurgitation) trial randomized HF patients with 3+ or 4+ SMR to MitraClip plus guideline-directed medical therapy (GDMT) versus GDMT alone. Two-year outcomes were evaluated in patients with versus without diabetes., Results: Of 614 patients, 229 (37.3%) had diabetes. Diabetic patients had higher 2-year rates of death than those without diabetes (40.8% vs 32.3%, respectively; adjusted P = 0.04) and tended to have higher rates of HF hospitalization (HFH) (HFH: 50.1% vs 43.0%, respectively; adjusted P = 0.07). TMVr reduced the 2-year rate of death consistently in patients with (30.3% vs 49.9%, respectively; adjusted HR: 0.51; 95% CI: 0.32 to 0.81) and without (27.0% vs 38.3%, respectively; adjusted HR: 0.57; 95% CI: 0.39-0.84) diabetes (P
interaction = 0.72). TMVr also consistently reduced the 2-year rates of HFH in patients with (32.2% vs 54.8%, respectively; adjusted HR: 0.41; 95% CI: 0.28-0.58) and without (41.5% vs 59.0%, respectively; adjusted HR: 0.54: 95% CI 0.35-0.82) diabetes (Pinteraction = 0.33). Greater movements in quality-of-life (QOL) and exercise capacity occurred with TMVr than with GDMT alone, regardless of diabetic status., Conclusions: Among HF patients with severe SMR in the COAPT trial, those with diabetes had a worse prognosis. Nonetheless, diabetic and nondiabetic patients had consistent reductions in the 2-year rates of death and HFH and improvements in QOL and functional capacity following TMVr treatment using the MitraClip than with maintenance on GDMT alone. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [COAPT]; NCT01626079)., Competing Interests: Funding Support and Author Disclosures The COAPT trial was supported by Abbott. Dr Shahim is supported by the Foundation Blanceflor and the Swedish Heart-Lung Foundation. Dr Madhavan has received an institutional grant to Columbia University Irving Medical Center from the National Institutes of Health/National Heart Lung Blood Institute grant T32 HL007854. Dr Kar is a consultant and an advisory board member for Boston Scientific; and is a consultant for and holds stock equity in Valcare; and is a consultant for WL Gore and Medtronic. Dr Lim has received research support from Abbott, Edwards Lifesciences, Medtronic, and WL Gore; and is a consultant for Abbott, Edwards Lifesciences, Keystone Heart, Pipeline, Siemens, Valgen, and Venus; and is an advisory board member for Ancora and Venus; and holds equity in 510Kardiac and Venus. Drs. Asch and Weissman have institutional contracts with Abbott, Neovasc, Ancora, Mitralign, Medtronic, Boston Scientific, Edwards Lifesciences, Biotronik, and Livanova. Dr Cohen has received research support from Abbott, Medtronic, Edwards Lifesciences, and Boston Scientific; and is a consultant for Abbott, Medtronic, Edwards Lifesciences, and Boston Scientific. Dr Lindenfeld has received research support from AstraZeneca; and is a consultant for Abbott Vascular, AstraZeneca, CVRx, Edwards Lifesciences, Impulse Dynamics, Boehringer Ingelheim, VoluMetrix, and V-Wave. Dr Abraham has received research support from Abbott Vascular; and he is a consultant for Abbott Vascular. Dr Mack has served as co-primary investigator for the PARTNER trial for Edwards Lifesciences, the COAPT trial for Abbott, and as study chair for the APOLLO trial for Medtronic. Dr Stone has received speaker and honoraria fees from Cook, Terumo, and Orchestra Biomed; and is a consultant for Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, WL Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, Matrizyme, and Cardiomech; and holds equity in Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, and MedFocus family of funds, Valfix. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2021
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19. Postoperative Atrial Fibrillation or Flutter Following Transcatheter or Surgical Aortic Valve Replacement: PARTNER 3 Trial.
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Shahim B, Malaisrie SC, George I, Thourani VH, Biviano AB, Russo M, Brown DL, Babaliaros V, Guyton RA, Kodali SK, Nazif TM, Kapadia S, Pibarot P, McCabe JM, Williams M, Genereux P, Lu M, Yu X, Alu M, Webb JG, Mack MJ, Leon MB, and Kosmidou I
- Subjects
- Aftercare, Aortic Valve diagnostic imaging, Aortic Valve surgery, Humans, Patient Discharge, Risk Factors, Severity of Illness Index, Treatment Outcome, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis epidemiology, Aortic Valve Stenosis surgery, Atrial Fibrillation diagnosis, Atrial Fibrillation epidemiology, Atrial Fibrillation etiology, Heart Valve Prosthesis Implantation adverse effects, Transcatheter Aortic Valve Replacement adverse effects
- Abstract
Objectives: The aim of this study was to assess the incidence and prognostic impact of early and late postoperative atrial fibrillation or flutter (POAF) in patients with severe aortic stenosis (AS) treated with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR)., Background: There is an ongoing controversy regarding the incidence, recurrence rate, and prognostic impact of early (in-hospital) POAF and late (postdischarge) POAF in patients with AS undergoing TAVR or SAVR., Methods: In the PARTNER (Placement of Aortic Transcatheter Valve) 3 trial, patients with severe AS at low surgical risk were randomized to TAVR or SAVR. Analyses were performed in the as-treated population excluding patients with preexistent atrial fibrillation or flutter., Results: Among 781 patients included in the analysis, early POAF occurred in 152 (19.5%) (18 of 415 [4.3%] and 134 of 366 [36.6%] following TAVR and SAVR, respectively). Following discharge, 58 new or recurrent late POAF events occurred within 1 year following the index procedure in 55 of 781 patients (7.0%). Early POAF was not an independent predictor of late POAF following discharge (odds ratio: 1.04; 95% CI: 0.52-2.08; P = 0.90). Following adjustment, early POAF was not an independent predictor of the composite outcome of death, stroke, or rehospitalization (hazard ratio: 1.10; 95% CI: 0.64-1.92; P = 0.72), whereas late POAF was associated with an increased adjusted risk for the composite outcome (hazard ratio: 8.90; 95% CI: 5.02-15.74; P < 0.0001), irrespective of treatment modality., Conclusions: In the PARTNER 3 trial, early POAF was more frequent following SAVR compared with TAVR. Late POAF, but not early POAF, was significantly associated with worse outcomes at 2 years, irrespective of treatment modality., Competing Interests: Funding Support and Author Disclosures The PARTNER 3 trial was funded by Edwards Lifesciences. Dr Malaisrie is a consultant for Edwards Lifesciences, Medtronic, and Abbott. Dr George is a consultant for Edwards Lifesciences. Dr Thourani does research and is a consultant for Abbott Vascular, Allergen, Boston Scientific, CryoLife, Edwards Lifesciences, Gore Vascular, and JenaValve. Dr Babaliaros has received institutional research funding from Abbott, Edwards Lifesciences, and Medtronic; has received consulting fees from Edwards Lifesciences; and holds equity in Transmural Systems. Dr Kodali has received institutional research grants from Edwards Lifesciences, Medtronic, and Abbott; has received consulting fees from Abbott, Admedus, and Meril Life; and holds equity options from Biotrace Medical and Thubrikar Aortic Valve. Dr Nazif is a consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Genereux has received consulting fees from Abbott Vascular, Abiomed, Boston Scientific, Cardinal Health, Cardiovascular Systems, Edwards Lifesciences, Medtronic, Opsens, Siemens, SoundBite Medical Solutions, Sig.Num, Saranas, Teleflex, and Tryton Medical; and has equity in Pi-Cardia, Sig.Num, SoundBite Medical Solutions, Saranas, and Puzzle Medical. Drs Lu and Yu are employees of Edwards Lifesciences. Ms Alu has received institutional research support (no direct compensation) from Abbott and Edwards Lifesciences. Dr Webb is a proctor and consultant for Edwards Lifesciences. Dr Mack has received institutional research support (no direct physician compensation) from Edwards Lifesciences. Dr Leon has received institutional research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and is a consultant or advisory board member for Medtronic, Boston Scientific, Gore, Meril Life, and Abbott. Dr Kosmidou has received institutional research support from Amgen; and is a consultant for Sanofi. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2021
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20. Long-term follow-up after ultrathin vs. conventional 2nd-generation drug-eluting stents: a systematic review and meta-analysis of randomized controlled trials.
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Madhavan MV, Howard JP, Naqvi A, Ben-Yehuda O, Redfors B, Prasad M, Shahim B, Leon MB, Bangalore S, Stone GW, and Ahmad Y
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- Absorbable Implants, Follow-Up Studies, Humans, Prosthesis Design, Randomized Controlled Trials as Topic, Treatment Outcome, Coronary Artery Disease surgery, Drug-Eluting Stents, Percutaneous Coronary Intervention
- Abstract
Aims: Contemporary 2nd-generation thin-strut drug-eluting stents (DES) are considered standard of care for revascularization of patients undergoing percutaneous coronary intervention. A previous meta-analysis of 10 randomized controlled trials (RCTs) with 11 658 patients demonstrated a 16% reduction in the 1-year risk of target lesion failure (TLF) with ultrathin-strut DES compared with conventional 2nd-generation thin-strut DES. Whether this benefit is sustained longer term is not known, and newer trial data may inform these relative outcomes. We therefore sought to perform an updated systematic review and meta-analysis of RCTs comparing clinical outcomes with ultrathin-strut DES (≤70 µm strut thickness) with conventional 2nd-generation thin-strut DES., Methods and Results: We performed a random-effects meta-analysis of all RCTs comparing ultrathin-strut DES to conventional 2nd-generation thin-strut DES. The pre-specified primary endpoint was long-term TLF, a composite of cardiac death, myocardial infarction (MI), or clinically driven target lesion revascularization (CD-TLR). Secondary endpoints included the components of TLF, stent thrombosis (ST), and all-cause death. There were 16 eligible trials in which 20 701 patients were randomized. The weighted mean follow-up duration was 2.5 years. Ultrathin-strut DES were associated with a 15% reduction in long-term TLF compared with conventional 2nd-generation thin-strut DES [relative risk (RR) 0.85, 95% confidence interval (CI) 0.76-0.96, P = 0.008] driven by a 25% reduction in CD-TLR (RR 0.75, 95% CI 0.62-0.92, P = 0.005). There were no significant differences between stent types in the risks of MI, ST, cardiac death, or all-cause mortality., Conclusions: At a mean follow-up of 2.5 years, ultrathin-strut DES reduced the risk of TLF, driven by less CD-TLR compared with conventional 2nd-generation thin-strut DES, with similar risks of MI, ST, cardiac death, and all-cause mortality., (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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- 2021
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21. Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Stenosis.
- Author
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Vincent F, Ternacle J, Denimal T, Shen M, Redfors B, Delhaye C, Simonato M, Debry N, Verdier B, Shahim B, Pamart T, Spillemaeker H, Schurtz G, Pontana F, Thourani VH, Pibarot P, and Van Belle E
- Subjects
- Aged, Aged, 80 and over, Female, Humans, Male, Aortic Valve Stenosis surgery, Bicuspid Aortic Valve Disease surgery, Transcatheter Aortic Valve Replacement methods
- Abstract
After 15 years of successive randomized, controlled trials, indications for transcatheter aortic valve replacement (TAVR) are rapidly expanding. In the coming years, this procedure could become the first line treatment for patients with a symptomatic severe aortic stenosis and a tricuspid aortic valve anatomy. However, randomized, controlled trials have excluded bicuspid aortic valve (BAV), which is the most frequent congenital heart disease occurring in 1% to 2% of the total population and representing at least 25% of patients 80 years of age or older referred for aortic valve replacement. The use of a less invasive transcatheter therapy in this elderly population became rapidly attractive, and approximately 10% of patients currently undergoing TAVR have a BAV. The U.S. Food and Drug Administration and the "European Conformity" have approved TAVR for low-risk patients regardless of the aortic valve anatomy whereas international guidelines recommend surgical replacement in BAV populations. Given this progressive expansion of TAVR toward younger and lower-risk patients, heart teams are encountering BAV patients more frequently, while the ability of this therapy to treat such a challenging anatomy remains uncertain. This review will address the singularity of BAV anatomy and associated technical challenges for the TAVR procedure. We will examine and summarize available clinical evidence and highlight critical knowledge gaps regarding TAVR utilization in BAV patients. We will provide a comprehensive overview of the role of computed tomography scans in the diagnosis, and classification of BAV and TAVR procedure planning. Overall, we will offer an integrated framework for understanding the current role of TAVR in the treatment of bicuspid aortic stenosis and for guiding physicians in clinical decision-making.
- Published
- 2021
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22. Pulmonary Hypertension in Transcatheter Mitral Valve Repair for Secondary Mitral Regurgitation: The COAPT Trial.
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Ben-Yehuda O, Shahim B, Chen S, Liu M, Redfors B, Hahn RT, Asch FM, Weissman NJ, Medvedofsky D, Puri R, Kapadia S, Sannino A, Grayburn P, Kar S, Lim S, Lindenfeld J, Abraham WT, Mack MJ, and Stone GW
- Subjects
- Echocardiography methods, Female, Humans, Male, Middle Aged, Prognosis, Risk Assessment methods, Risk Assessment statistics & numerical data, Risk Factors, Severity of Illness Index, Treatment Outcome, Cardiac Catheterization methods, Heart Failure etiology, Heart Failure physiopathology, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation methods, Hypertension, Pulmonary etiology, Hypertension, Pulmonary physiopathology, Mitral Valve diagnostic imaging, Mitral Valve pathology, Mitral Valve surgery, Mitral Valve Insufficiency complications, Mitral Valve Insufficiency diagnosis, Mitral Valve Insufficiency physiopathology, Mitral Valve Insufficiency surgery, Postoperative Complications diagnosis, Postoperative Complications mortality
- Abstract
Background: Pulmonary hypertension worsens prognosis in patients with heart failure (HF) and secondary mitral regurgitation (SMR)., Objectives: This study sought to determine whether baseline pulmonary hypertension influences outcomes of transcatheter mitral valve repair (TMVr) in patients with HF with SMR., Methods: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, 614 patients with HF with moderate-to-severe or severe SMR were randomized to TMVr with the MitraClip plus guideline-directed medical therapy (GDMT) (n = 302) versus GDMT alone (n = 312). Baseline pulmonary artery systolic pressure (PASP) estimated from echocardiography was categorized as substantially increased (≥50 mm Hg) versus not substantially increased (<50 mm Hg)., Results: Among 528 patients, 184 (82 TMVr, 102 GDMT) had PASP of ≥50 mm Hg (mean: 59.1 ± 8.8 mm Hg) and 344 (171 TMVr, 173 GDMT) had PASP of <50 mm Hg (mean: 36.3 ± 8.1 mm Hg). Patients with PASP of ≥50 mm Hg had higher 2-year rates of death or HF hospitalization (HFH) compared to those with PASP of <50 mm Hg (68.8% vs. 49.1%; adjusted hazard ratio: 1.52; 95% confidence interval: 1.17 to 1.97; p = 0.002). Rates of death or HFH were reduced by TMVr versus GDMT alone, irrespective of baseline PASP (p
interaction = 0.45). TMVr reduced PASP from baseline to 30 days to a greater than GDMT alone (adjusted least squares mean: -4.0 vs. -0.9 mm Hg; p = 0.006), a change that was associated with reduced risk of death or HFH between 30 days and 2 years (adjusted hazard ratio: 0.91 per -5 mm Hg PASP; 95% confidence interval: 0.86 to 0.96; p = 0.0009)., Conclusions: Elevated PASP is associated with a worse prognosis in patients with HF with severe SMR. TMVr with the MitraClip reduced 30-day PASP and 2-year rates of death or HFH compared with GDMT alone, irrespective of PASP., Competing Interests: Author Disclosures The COAPT trial was funded by Abbott. Drs. Ben-Yehuda, Shahim, and Redfors are employees of the Cardiovascular Research Foundation which has received research grants in connection with the COAPT trial from Abbott; they have no personal financial relationships with Abbott. Dr. Hahn has received speaker fees from Boston Scientific Corporation, Baylis Medical, Edwards Lifesciences, and Medtronic; has been a consultant for Abbott Structural, Edwards Lifesciences, Gore & Associates, Medtronic, Navigate, and Philips Healthcare; has received nonfinancial support from 3mensio; has equity with Navigate; and is the chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Drs. Asch and Weissman are the director and associate director, respectively, of an academic echocardiography core laboratory with institutional contracts with Abbott, Neovasc, Ancora, Medtronic, Boston Scientific, Edwards Lifesciences, Biotronik, and Livanova. Dr. Grayburn has received research grant support from Abbott, Edwards Lifesciences, Medtronic, W.L. Gore, and Boston Scientific; has consulted for Abbott, Edwards, Medtronic, and Neochord; and has imaging core laboratory contracts with Edwards Lifesciences, Neochord, W.L. Gore, and Cardiovalve. Dr. Kar has received research grant support from Abbott, Boston Scientific, Edwards Lifesciences, and Mitralign; and has received consulting income from Abbott and Boston Scientific. Dr. Lim has received research grant support and consulting fees from Abbott Vascular. Dr. Lindenfeld has received consulting fees from Abbott, AstraZeneca, Edwards Lifesciences, Relypsa, Boehringer Ingelheim, V-Wave, CVRx, and Impulse Dynamics; and has received research grant support from AstraZeneca. Dr. Abraham has received research grant support from Abbott; and has received consulting fees from Abbott and Edwards Lifesciences. Dr. Mack has served as coprincipal investigator for the Edwards Lifesciences–sponsored PARTNER 3 trial and the Abbott-sponsored COAPT trial; and has served as study chairman for the Medtronic-sponsored APOLLO trial. Dr. Stone has received speaker honoraria from Cook and Terumo; has served as a consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, and Matrizyme; and owns equity/options in Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, the MedFocus family of funds, and Valfix. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2020
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23. Transcatheter Mitral Valve Repair in Patients With and Without Cardiac Resynchronization Therapy: The COAPT Trial.
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Kosmidou I, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant BK, Kipperman RM, Boudoulas KD, Redfors B, Shahim B, Zhang Z, Mack MJ, and Stone GW
- Subjects
- Aged, Aged, 80 and over, Female, Heart Failure diagnosis, Heart Failure mortality, Heart Failure physiopathology, Hospitalization, Humans, Male, Middle Aged, Mitral Valve physiopathology, Mitral Valve Insufficiency diagnosis, Mitral Valve Insufficiency mortality, Mitral Valve Insufficiency physiopathology, Quality of Life, Recovery of Function, Severity of Illness Index, Time Factors, Treatment Outcome, United States, Cardiac Catheterization adverse effects, Cardiac Catheterization instrumentation, Cardiac Resynchronization Therapy adverse effects, Cardiac Resynchronization Therapy mortality, Heart Failure therapy, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation mortality, Mitral Valve surgery, Mitral Valve Insufficiency surgery
- Abstract
Background: In the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation), treatment of heart failure (HF) patients with moderate-severe or severe secondary mitral regurgitation with transcatheter mitral valve repair (TMVr) using the MitraClip plus guideline-directed medical therapy (GDMT) reduced 2-year rates of HF hospitalization and all-cause mortality compared with GDMT alone. Whether the benefits of the MitraClip extend to patients with previously implanted cardiac resynchronization therapy (CRT) is unknown. We sought to examine the effect of prior CRT in patients enrolled in COAPT., Methods: Patients (N=614) with moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated doses of GDMT were randomized 1:1 to the MitraClip (TMVr arm) versus GDMT only (control arm). Outcomes were assessed according to prior CRT use., Results: Among 614 patients, 224 (36.5%) had prior CRT (115 and 109 randomized to TMVr and control, respectively) and 390 (63.5%) had no CRT (187 and 203 randomized to TMVr and control, respectively). Patients with CRT had similar 2-year rates of the composite of death or HF hospitalization compared with those without CRT (57.6% versus 55%, P =0.32). Death or HF hospitalization at 2 years was lower with TMVr versus control treatment in patients with prior CRT (48.6% versus 67.2%, hazard ratio, 0.60 [95% CI, 0.42-0.86]) and without CRT (42.5% versus 66.9%, hazard ratio, 0.52 [95% CI, 0.39-0.69]; adjusted P
interaction =0.23). The effects of TMVr with the MitraClip on reducing the 2-year rates of all-cause death (adjusted Pinteraction =0.14) and HF hospitalization (adjusted Pinteraction =0.82) were also consistent in patients with and without CRT as were improvements in quality-of-life and exercise capacity., Conclusions: In the COAPT trial, TMVr with the MitraClip improved the 2-year prognosis of patients with HF and moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated GDMT, regardless of prior CRT implantation. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01626079.- Published
- 2020
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24. Impact of Tricuspid Regurgitation on Clinical Outcomes: The COAPT Trial.
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Hahn RT, Asch F, Weissman NJ, Grayburn P, Kar S, Lim S, Ben-Yehuda O, Shahim B, Chen S, Liu M, Redfors B, Medvedofsky D, Puri R, Kapadia S, Sannino A, Lindenfeld J, Abraham WT, Mack MJ, and Stone GW
- Subjects
- Aged, Aged, 80 and over, Echocardiography trends, Female, Follow-Up Studies, Heart Failure epidemiology, Humans, Male, Middle Aged, Mitral Valve Insufficiency epidemiology, Surgical Instruments trends, Treatment Outcome, Tricuspid Valve Insufficiency epidemiology, Heart Failure diagnostic imaging, Heart Failure surgery, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency surgery, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency surgery
- Abstract
Background: The presence of tricuspid regurgitation (TR) may affect prognosis in patients with mitral regurgitation (MR)., Objectives: This study sought to determine the impact of TR on outcomes in patients with heart failure and severe secondary MR randomized to guideline-directed medical therapy (GDMT) or edge-to-edge repair with the MitraClip in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial., Methods: A total of 614 patients with symptomatic heart failure with moderate to severe (3+) or severe (4+) secondary MR were randomized to maximally tolerated GDMT plus MitraClip or GDMT alone; 599 had core laboratory evaluable echocardiograms. Patients were divided into 2 groups by baseline TR severity: none/trace/mild TR (≤Mild TR) (n = 501 [83.6%]) and moderate/severe TR (≥Mod TR) (n = 98 [16.4%]). Two-year composite endpoints of death or heart failure hospitalization (HFH) and the individual endpoints were analyzed., Results: Patients with ≥Mod TR were more likely to be New York Heart Association functional class III/IV (p < 0.0001) and have a Society of Thoracic Surgeons score of ≥8 (p < 0.0001), anemia (p = 0.02), chronic kidney disease (p = 0.003), and higher N-terminal pro-B-type natriuretic peptide (p = 0.02) than those with ≤Mild TR. Patients with ≥Mod TR had more severe MR (p = 0.0005) despite smaller left ventricular volumes (p = 0.005) and higher right ventricular systolic pressure (p < 0.0001). At 2 years, the composite rate of death or HFH was higher in patients with ≥Mod TR compared with ≤Mild TR treated with GDMT alone (83.0% vs. 64.3%; hazard ratio: 1.74; 95% confidence interval: 1.24 to 2.45; p = 0.001) but not following MitraClip (48.2% vs. 44.0%; hazard ratio: 1.14; 95% confidence interval: 0.71 to 1.84; p = 0.59). Rates of death or HFH, as well as death and HFH alone, were reduced by MitraClip compared with GDMT, irrespective of baseline TR grade (p
interaction = 0.16, 0.29, and 0.21 respectively)., Conclusions: Patients with severe secondary MR who also had ≥Mod TR had worse clinical and echocardiographic characteristics and worse clinical outcomes compared to those with ≤Mild TR. Within the COAPT trial, MitraClip improved outcomes in patients with and without ≥Mod TR severity compared with GDMT alone. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [COAPT]; NCT01626079)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2020
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25. BMI, Infarct Size, and Clinical Outcomes Following Primary PCI: Patient-Level Analysis From 6 Randomized Trials.
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Shahim B, Redfors B, Chen S, Thiele H, Eitel I, Gkargkoulas F, Crowley A, Ben-Yehuda O, Maehara A, and Stone GW
- Subjects
- Aged, Female, Heart Failure mortality, Heart Failure physiopathology, Heart Failure therapy, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Obesity mortality, Obesity physiopathology, Patient Readmission, Predictive Value of Tests, Randomized Controlled Trials as Topic, Risk Assessment, Risk Factors, ST Elevation Myocardial Infarction diagnostic imaging, ST Elevation Myocardial Infarction mortality, ST Elevation Myocardial Infarction physiopathology, Stroke Volume, Time Factors, Tomography, Emission-Computed, Single-Photon, Treatment Outcome, Ventricular Function, Left, Body Mass Index, Myocardium pathology, Obesity diagnosis, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention mortality, ST Elevation Myocardial Infarction therapy
- Abstract
Objectives: The aim of this study was to examine the association between body mass index (BMI), infarct size (IS) and clinical outcomes., Background: The association between obesity, IS, and prognosis in patients undergoing primary percutaneous coronary intervention (pPCI) for ST-segment elevation myocardial infarction is incompletely understood., Methods: An individual patient-data pooled analysis was performed from 6 randomized trials of patients undergoing pPCI for ST-segment elevation myocardial infarction in which IS (percentage left ventricular mass) was assessed within 1 month (median 4 days) after randomization using either cardiac magnetic resonance (5 studies) or
99m Tc sestamibi single-photon emission computed tomography (1 study). Patients were classified as normal weight (BMI <25 kg/m2 ), overweight (25 kg/m2 ≤BMI <30 kg/m2 ), or obese (BMI ≥30 kg/m2 ). The multivariable models were adjusted for age, sex, hypertension, hyperlipidemia, current smoking, left main or left anterior descending coronary artery infarct, baseline TIMI (Thrombolysis In Myocardial Infarction) flow grade 0 or 1, prior myocardial infarction, symptom-to-first device time, and study., Results: Among 2,238 patients undergoing pPCI, 644 (29%) were normal weight, 1,008 (45%) were overweight, and 586 (26%) were obese. BMI was not significantly associated with IS, microvascular obstruction, or left ventricular ejection fraction in adjusted or unadjusted analysis. BMI was also not associated with the 1-year composite risk for death or heart failure hospitalization (adjusted hazard ratio: 1.21 [95% confidence interval: 0.74 to 1.71] for overweight vs. normal [p = 0.59]; adjusted hazard ratio: 1.21 [95% confidence interval 0.74 to 1.97] for obese vs. normal [p = 0.45]) or for death or heart failure hospitalization separately. Results were consistent when BMI was modeled as a continuous variable., Conclusions: In this individual patient-data pooled analysis of 2,238 patients undergoing pPCI for ST-segment elevation myocardial infarction, BMI was not associated with IS, microvascular obstruction, left ventricular ejection fraction, or 1-year rates of death or heart failure hospitalization., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2020
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26. Long-Term Outcomes After Revascularization for Stable Ischemic Heart Disease: An Individual Patient-Level Pooled Analysis of 19 Randomized Coronary Stent Trials.
- Author
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Madhavan MV, Redfors B, Ali ZA, Prasad M, Shahim B, Smits PC, von Birgelen C, Zhang Z, Mehran R, Serruys PW, Maehara A, Leon MB, Kirtane AJ, and Stone GW
- Subjects
- Aged, Female, Humans, Male, Middle Aged, Myocardial Ischemia diagnostic imaging, Myocardial Ischemia mortality, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention mortality, Prosthesis Design, Randomized Controlled Trials as Topic, Recurrence, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Drug-Eluting Stents, Myocardial Ischemia therapy, Percutaneous Coronary Intervention instrumentation
- Abstract
Background: Whether revascularization improves prognosis in stable ischemic heart disease is controversial., Methods: Individual patient-level data from 19 prospective, randomized stent trials were pooled. Rates of 5-year major adverse cardiovascular events (MACE; a composite of cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization) were assessed and compared after percutaneous coronary intervention with bare-metal stents (BMS) and first-generation and second-generation drug-eluting stents (DES1 and DES2, respectively). Poisson multivariable regression analysis was performed to identify predictors of adverse events., Results: Among 10 987 patients treated with percutaneous coronary intervention for stable ischemic heart disease, 1550, 2776, and 6661 received BMS, DES1, and DES2, respectively. The 5-year rates of MACE progressively declined with evolution in stent technology (BMS: 24.1% versus DES1: 17.9% versus DES2: 13.4%, P <0.0001). However, MACE rates between 1 and 5 years increased from BMS to DES1, then declined with DES2 (BMS: 7.4% versus DES1: 10.2%, DES2: 8.5%, P =0.02)., Conclusions: Patients with stable ischemic heart disease remain at substantial risk for long-term MACE after revascularization with percutaneous coronary intervention, even with contemporary DES. New approaches to reduce the ongoing risk of MACE beyond 1 year after stent implantation are necessary.
- Published
- 2020
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27. Cardiogenic shock triggered by phaeochromocytoma crisis after an oral glucose tolerance test: a case report.
- Author
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Shahim B, Faxén UL, Stern R, and Freyschuss A
- Abstract
Background: Phaeochromocytomas are rare catecholamine-producing tumours which typically present with comparatively benign symptoms such as headache, palpitations, sweating, hypertension, and insulin resistance. In rare cases, severe cardiac manifestations have been reported. We describe a patient who developed severe hypoglycaemia after an oral glucose tolerance test (OGTT), potentially triggering a phaeochromocytoma crisis and cardiogenic shock. To the best of our knowledge, only four other cases of hypoglycaemia after OGTT have been reported in patients with phaeochromocytoma, of which none developed a phaeochromocytoma crisis., Case Summary: A 53-year-old woman with hypertension, dyslipidaemia, and prediabetes presented to the Emergency Department with hypoxia, hyperglycaemia, lactic acidosis, severe left ventricular dysfunction, and pulmonary oedema followed by cardiogenic shock. Onset of symptoms was only few hours after an OGTT during which she had developed severe transient hypoglycaemia. Angiography was performed due to elevated troponin levels and showed a midventricular contraction pattern typical of takotsubo. This was subsequently confirmed by cardiac magnetic resonance imaging. The patient's condition improved during the first 36 h and she was discharged home on Day 7. A positive catecholamine test prompted readmission to the Endocrinology Unit, where computer tomography confirmed the diagnosis of phaeochromocytoma. An adrenalectomy was performed, and the diagnosis was verified histopathologically., Discussion: The possibility of a phaeochromocytoma must be considered as a potential triggering factor in patients presenting with takotsubo cardiomyopathy, in particular, when blood glucose levels fluctuate between severe hypo- and hyperglycaemia., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2019
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28. On the prognostic value of post-load glucose in patients with coronary artery disease.
- Author
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Rydén L, Shahim B, and Standl E
- Subjects
- Glucose, Humans, Prognosis, Acute Coronary Syndrome, Coronary Artery Disease, Diabetes Mellitus
- Published
- 2018
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29. Undetected dysglycaemia common in primary care patients treated for hypertension and/or dyslipidaemia: on the need for a screening strategy in clinical practice. A report from EUROASPIRE IV a registry from the EuroObservational Research Programme of the European Society of Cardiology.
- Author
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Shahim B, Gyberg V, De Bacquer D, Kotseva K, De Backer G, Schnell O, Tuomilehto J, Wood D, and Rydén L
- Subjects
- Adolescent, Adult, Aged, Algorithms, Biomarkers blood, Blood Glucose analysis, Blood Pressure drug effects, Cross-Sectional Studies, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 epidemiology, Dyslipidemias blood, Dyslipidemias diagnosis, Dyslipidemias epidemiology, Europe epidemiology, Female, Glucose Intolerance blood, Glucose Intolerance epidemiology, Glycated Hemoglobin analysis, Humans, Hypertension diagnosis, Hypertension epidemiology, Hypertension physiopathology, Lipids blood, Male, Middle Aged, Predictive Value of Tests, Prevalence, Registries, Risk Factors, Young Adult, Diabetes Mellitus, Type 2 diagnosis, Dyslipidemias drug therapy, Glucose Intolerance diagnosis, Glucose Tolerance Test, Hypertension drug therapy, Hypoglycemic Agents therapeutic use, Hypolipidemic Agents therapeutic use, Mass Screening methods
- Abstract
Background: Dysglycaemia defined as type 2 diabetes (T2DM) and impaired glucose tolerance (IGT), increases the risk of cardiovascular disease (CVD). The negative impact is more apparent in the presence of hypertension and/or dyslipidaemia. Thus, it seems reasonable to screen for dysglycaemia in patients treated for hypertension and/or dyslipidaemia. A simple screening algorithm would enhance the adoption of such strategy in clinical practice., Objectives: To test the hypotheses (1) that dysglycaemia is common in patients with hypertension and/or dyslipidaemia and (2) that initial screening with the Finnish Diabetes Risk Score (FINDRISC) will decrease the need for laboratory based tests., Methods: 2395 patients (age 18-80 years) without (i) a history of CVD or TDM2, (ii) prescribed blood pressure and/or lipid lowering drugs answered the FINDRISC questionnaire and had an oral glucose tolerance test (OGTT) and HbA1c measured., Results: According to the OGTT 934 (39%) had previously undetected dysglycaemia (T2DM 19%, IGT 20%). Of patients, who according to FINDRISC had a low, moderate or slightly elevated risk 20, 34 and 41% and of those in the high and very high-risk category 49 and 71% had IGT or T2DM respectively. The OGTT identified 92% of patients with T2DM, FPG + HbA1c 90%, FPG 80%, 2hPG 29% and HbA1c 22%., Conclusions: (1) The prevalence of dysglycaemia was high in patients treated for hypertension and/or dyslipidaemia. (2) Due to the high proportion of dysglycaemia in patients with low to moderate FINDRISC risk scores its initial use did not decrease the need for subsequent glucose tests. (3) FPG was the best test for detecting T2DM. Its isolated use is limited by the inability to disclose IGT. A pragmatic strategy, decreasing the demand for an OGTT, would be to screen all patients with FPG followed by OGTT in patients with IFG.
- Published
- 2018
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30. The Prognostic Value of Fasting Plasma Glucose, Two-Hour Postload Glucose, and HbA 1c in Patients With Coronary Artery Disease: A Report From EUROASPIRE IV: A Survey From the European Society of Cardiology.
- Author
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Shahim B, De Bacquer D, De Backer G, Gyberg V, Kotseva K, Mellbin L, Schnell O, Tuomilehto J, Wood D, and Rydén L
- Subjects
- Adult, Cholesterol blood, Cohort Studies, Coronary Artery Disease complications, Diabetes Mellitus etiology, Exercise, Fasting, Female, Follow-Up Studies, Glucose Tolerance Test, Humans, Male, Middle Aged, Postprandial Period, Prognosis, Proportional Hazards Models, Societies, Medical, Surveys and Questionnaires, Blood Glucose metabolism, Coronary Artery Disease blood, Diabetes Mellitus blood, Diabetes Mellitus diagnosis, Diabetes Mellitus epidemiology, Glycated Hemoglobin metabolism
- Abstract
Objective: Three tests are recommended for identifying dysglycemia: fasting glucose (FPG), 2-h postload glucose (2h-PG) from an oral glucose tolerance test (OGTT), and glycated hemoglobin A
1c (HbA1c ). This study explored the prognostic value of these screening tests in patients with coronary artery disease (CAD)., Research Design and Methods: FPG, 2h-PG, and HbA1c were used to screen 4,004 CAD patients without a history of diabetes (age 18-80 years) for dysglycemia. The prognostic value of these tests was studied after 2 years of follow-up. The primary end point included cardiovascular mortality, nonfatal myocardial infarction, stroke, or hospitalization for heart failure and a secondary end point of incident diabetes., Results: Complete information including all three glycemic parameters was available in 3,775 patients (94.3%), of whom 246 (6.5%) experienced the primary end point. Neither FPG nor HbA1c predicted the primary outcome, whereas the 2h-PG, dichotomized as <7.8 vs. ≥7.8 mmol/L, was a significant predictor (hazard ratio 1.38, 95% CI 1.07-1.78; P = 0.01). During follow-up, diabetes developed in 78 of the 2,609 patients (3.0%) without diabetes at baseline. An FPG between 6.1 and 6.9 mmol/L did not predict incident diabetes, whereas HbA1c 5.7-6.5% and 2h-PG 7.8-11.0 mmol/L were both significant independent predictors., Conclusions: The 2h-PG, in contrast to FPG and HbA1c , provides significant prognostic information regarding cardiovascular events in patients with CAD. Furthermore, elevated 2h-PG and HbA1c are significant prognostic indicators of an increased risk of incident diabetes., (© 2017 by the American Diabetes Association.)- Published
- 2017
- Full Text
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