6,115 results on '"Sorajja, P."'
Search Results
2. Impact of age on hospital outcomes after catheter ablation for ventricular tachycardia
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Min Choon Tan, Yong Hao Yeo, Qi Xuan Ang, Chrystina Kiwan, Olubadewa Fatunde, Justin Z. Lee, Aneesh Tolat, and Dan Sorajja
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adult ,catheter ablation ,elderly ,hospital outcome ,ventricular tachycardia ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Abstract Background The real‐world data on the safety profile of ventricular tachycardia (VT) ablation among elderly patients is not well‐established. This study aimed to evaluate the procedural outcomes among those aged 18–64 years versus those aged ≥65 years who underwent catheter ablation of VT. Method Using the Nationwide Readmissions Database, our study included patients aged ≥18 years who underwent VT catheter ablation between 2017 and 2020. We divided the patients into non‐elderly (18–64 years old) and elderly age groups (≥65 years old). We then analyzed the in‐hospital procedural outcome and 30‐day readmission between these two groups. Results Our study included 2075 (49.1%) non‐elderly patients and 2153 (50.9%) elderly patients who underwent VT ablation. Post‐procedurally, elderly patients had significantly higher rates of prolonged index hospitalization (≥7 days; 35.5% vs. 29.3%, p
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- 2024
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3. Sinus Tachycardia: a Multidisciplinary Expert Focused Review.
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Mayuga, Kenneth, Fedorowski, Artur, Ricci, Fabrizio, Gopinathannair, Rakesh, Dukes, Jonathan, Gibbons, Christopher, Hanna, Peter, Sorajja, Dan, Chung, Mina, Benditt, David, Sheldon, Robert, Ayache, Mirna, AbouAssi, Hiba, Grubb, Blair, Hamdan, Mohamed, Stavrakis, Stavros, Singh, Tamanna, Goldberger, Jeffrey, Muldowney, James, Belham, Mark, Kem, David, Akin, Cem, Bruce, Barbara, Zahka, Nicole, Fu, Qi, Van Iterson, Erik, Raj, Satish, Fouad-Tarazi, Fetnat, Goldstein, David, Stewart, Julian, Olshansky, Brian, and Shivkumar, Kalyanam
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autonomic dysfunction ,hyperthyroidism ,inappropriate sinus tachycardia ,post-COVID syndrome ,postural orthostatic tachycardia syndrome ,sinus tachycardia ,COVID-19 ,Humans ,Postural Orthostatic Tachycardia Syndrome ,Tachycardia ,Sinus - Abstract
Sinus tachycardia (ST) is ubiquitous, but its presence outside of normal physiological triggers in otherwise healthy individuals remains a commonly encountered phenomenon in medical practice. In many cases, ST can be readily explained by a current medical condition that precipitates an increase in the sinus rate, but ST at rest without physiological triggers may also represent a spectrum of normal. In other cases, ST may not have an easily explainable cause but may represent serious underlying pathology and can be associated with intolerable symptoms. The classification of ST, consideration of possible etiologies, as well as the decisions of when and how to intervene can be difficult. ST can be classified as secondary to a specific, usually treatable, medical condition (eg, pulmonary embolism, anemia, infection, or hyperthyroidism) or be related to several incompletely defined conditions (eg, inappropriate ST, postural tachycardia syndrome, mast cell disorder, or post-COVID syndrome). While cardiologists and cardiac electrophysiologists often evaluate patients with symptoms associated with persistent or paroxysmal ST, an optimal approach remains uncertain. Due to the many possible conditions associated with ST, and an overlap in medical specialists who see these patients, the inclusion of experts in different fields is essential for a more comprehensive understanding. This article is unique in that it was composed by international experts in Neurology, Psychology, Autonomic Medicine, Allergy and Immunology, Exercise Physiology, Pulmonology and Critical Care Medicine, Endocrinology, Cardiology, and Cardiac Electrophysiology in the hope that it will facilitate a more complete understanding and thereby result in the better care of patients with ST.
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- 2022
4. Tricuspid Valve Leaflets–Lead Interaction
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Davide Margonato, MD, Maurice Enriquez-Sarano, MD, Cheng Wang, MD, Asa Phichaphop, MD, Atsushi Okada, MD, PhD, Hideki Koike, MD, Miho Fukui, MD, PhD, Nadira Hamid, MD, John Lesser, MD, Paul Sorajja, MD, Vinayak Bapat, MD, and João L. Cavalcante, MD
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cardiac computed tomography ,cardiac implantable electronic device ,tricuspid regurgitation ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
The diagnostic approach toward the management of cardiac implantable electronic device–related tricuspid regurgitation is challenging and undefined. Functional cardiac computed tomography angiography provides a complementary role to echocardiography in the evaluation of lead-leaflet interaction which can help the clinical decision-making process, as presented in this case series.
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- 2024
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5. Temporal Trends, Outcomes, and Predictors of Next‐Day Discharge and Readmission Following Uncomplicated Evolut Transcatheter Aortic Valve Replacement: A Propensity Score–Matched Analysis
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Wayne B. Batchelor, Carlos E. Sanchez, Paul Sorajja, James E. Harvey, Benjamin Z. Galper, Anapoorna Kini, Patricia Keegan, Kendra J. Grubb, Ruth Eisenberg, and Toby Rogers
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30‐day readmission ,next‐day discharge ,self‐expanding transcatheter aortic valve replacement ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Background Next‐day discharge (NDD) outcomes following uncomplicated self‐expanding transcatheter aortic valve replacement have not been studied. Here, we compare readmission rates and clinical outcomes in NDD versus non‐NDD transcatheter aortic valve replacement with Evolut. Methods and Results Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry patients (n=29 597) undergoing elective transcatheter aortic valve replacement with self‐expanding supra‐annular valves (Evolut R, PRO, and PRO+) from July 2019 to June 2021 were stratified by postprocedure length of stay: ≤1 day (NDD) versus >1 day (non‐NDD). Propensity score matching was used to compare risk adjusted 30‐day readmission rates and 1‐year outcomes in NDD versus non‐NDD, and multivariable regression to determine predictors of NDD and readmission. Between the first and last calendar quarter, the rate of NDD increased from 45.4% to 62.1% and median length of stay decreased from 2 days to 1. Propensity score matching produced relatively well‐matched NDD and non‐NDD cohorts (n=10 549 each). After matching, NDD was associated with lower 30‐day readmission rates (6.3% versus 8.4%; P
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- 2024
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6. Adverse events in cryoballoon ablation for pulmonary vein isolation: Insight from the Food and Drug Administration Manufacturer and User Facility Device Experience
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Min Choon Tan, Jian Liang Tan, Wei Jun Lee, Komandoor Srivathsan, Dan Sorajja, Hicham El Masry, Luis R. Scott, and Justin Z. Lee
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adverse events ,atrial fibrillation ,cryoballoon ablation ,outcome assessment ,pulmonary vein isolation ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Abstract Background Real‐world clinical data on the adverse events related to the use of cryoballoon catheter for pulmonary vein isolation remains limited. Objective To report and describe the adverse events related to the use of Artic Front cryoballoon catheters (Arctic Front, Arctic Front Advance, and Arctic Front Advance Pro) reported in the Food and Drug Administration's (FDA) Manufacturers and User Defined Experience (MAUDE) database. Methods We reviewed all the adverse events reported to the FDA MAUDE database over a 10.7‐year study period from January 01, 2011 to September 31, 2021. All events were independently reviewed by two physicians. Results During the study period, a total of 320 procedural‐related adverse events reported in the MAUDE database were identified. The most common adverse event was transient or persistent phrenic nerve palsy (PNP), accounting for 48% of all events. This was followed by cardiac perforation (15%), pulmonary vein stenosis (8%), transient ischemic attack or stroke (6%), vascular injury (4%), transient or persistent ST‐elevation myocardial infarction (3%), hemoptysis (2%), pericarditis (2%), and esophageal ulcer or fistula (1%). There were six reported intra‐procedural death events as a result of cardiac perforation. Conclusion The two most common procedural adverse events associated with cryoballoon ablation were PNP and cardiac perforation. All cases of procedural mortality were due to cardiac perforation.
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- 2023
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7. Subcutaneous implantable cardioverter‐defibrillator noise following left ventricular assist device implantation
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Banveet Kaur Khetarpal, Awad Javaid, Justin Z. Lee, Fred Kusumoto, Siva K. Mulpuru, Dan Sorajja, Yong‐Mei Cha, and Komandoor Srivathsan
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electromagnetic interference ,left ventricular assist device ,oversensing ,subcutaneous implantable cardioverter defibrillator ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Abstract Background The incidence and impact of noise in a subcutaneous implantable cardioverter defibrillator (S‐ICD) after left ventricular assist device (LVAD) implantation is not well established. Methods We performed a retrospective study of patients implanted with LVAD and with a pre‐existing S‐ICD between January 2005 and December 2020 at the three Mayo Clinic centers (Minnesota, Arizona, and Florida). Results Of the 908 LVAD patients, a pre‐existing S‐ICD was present in 9 patients (mean age 49.1 ± 13.7 years, 66.7% males), 100% with Boston Scientific third‐generation EMBLEM MRI S‐ICD, 11% with HeartMate II (HM II), 44% with HeartMate 3 (HM 3), and 44% with HeartWare (HW) LVAD. The incidence of noise from LVAD‐related electromagnetic interference (EMI) was 33% and was only seen with HM 3 LVAD. Multiple measures attempted to resolve noise, including using alternative S‐ICD sensing vector, adjusting S‐ICD time zone, and increasing LVAD pump speed, were unsuccessful, necessitating S‐ICD device therapies to be turned off permanently. Conclusions The incidence of LVAD‐related S‐ICD noise is high in patients with concomitant LVAD and S‐ICD with significant impact on device function. As conservative management failed to resolve the EMI, the S‐ICDs had to be programmed off to avoid inappropriate shocks. This study highlights the importance of awareness of LVAD‐SICD device interference and the need to improve S‐ICD detection algorithms to eliminate noise.
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- 2023
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8. 3-Dimensional Multiplanar Reconstruction With Transesophageal Echocardiography for Alcohol Septal Ablation
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Konstaninos Voudris, MD, PhD, John Lesser, MD, Paul Sorajja, MD, and Nadira Hamid, MD
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alcohol septal ablation ,multiplanar reconstruction ,transesophageal echocardiography ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
This study described the first experience with 3-dimensional multiplanar reconstruction transesophageal echocardiography to guide percutaneous alcohol septal ablation. This study demonstrated that 3-dimensional transesophageal echocardiography multiplanar reconstruction allowed for simultaneous assessment of the targeted myocardial area from left ventricular base to apex, akin to imaging seen with spatial imaging with cardiac magnetic resonance. (Level of Difficulty: Intermediate.)
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- 2023
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9. Sinus Node Dysfunction After Percutaneous Transcatheter Closure of Right Coronary Artery–Superior Vena Cava Fistula
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Anil Sriramoju, MD, Mustafa Suppah, MD, Chieh-Ju Chao, MD, Dan Sorajja, MD, John Sweeney, MD, Sailendra Naidu, MD, and Richard Lee, MD
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embolization ,fistula ,junctional rhythm ,palpitations ,sinus node ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Congenital right coronary artery-superior vena cava (RCA-SVC) fistula is rare and typically does not manifest any symptoms until the fifth decade of life. The present case demonstrates a 48-year-old woman who developed Sinus node dysfunction of unknown cause after Percutaneous coil embolization of the RCA-SVC fistula requiring permanent pacemaker. (Level of Difficulty: Intermediate.)
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- 2023
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10. Paravalvular Regurgitation: an Overview of Indications for Closure and Management Strategies
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Sato, Hirotomo and Sorajja, Paul
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- 2022
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11. Sex differences in methylation profiles are apparent in medulloblastoma, particularly among SHH tumors
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Rachel M. Moss, Natali Sorajja, Lauren J. Mills, Christopher L. Moertel, Thanh T. Hoang, Logan G. Spector, David A. Largaespada, and Lindsay A. Williams
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medulloblastoma ,sex differences ,methylation ,survival ,pediatric and young adult cancer ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
BackgroundMedulloblastoma, the most common malignant pediatric brain tumor, displays marked sex differences in prevalence of the four main molecular subgroups: SHH, WNT, Group 3 and Group 4. Males are more frequently diagnosed with SHH, Group 3 and 4 tumors, which have worse prognoses than WNT tumors. Little is known about sex differences in methylation profiles within subgroups.MethodsUsing publicly available methylation data (Illumina HumanMethylation450K array), we compared beta values for males versus females. Differentially methylated positions (DMP) by sex within medulloblastoma subgroups were identified on the autosomes. DMPs were mapped to genes and Reactome pathway analysis was run by subgroup. Kaplan-Meier survival curves (Log-Rank p-values) were assessed for each sex within subgroup. MethylCIBERSORT was used to investigate the tumor microenvironment using deconvolution to estimate the abundances of immune cell types using DNA methylation data.ResultsThere were statistically significant differences in sex by medulloblastoma subgroups (chi-squared p-value=0.00004): Group 3 (n=144; 65% male), Group 4 (n=326; 67% male), SHH (n=223; 57% male) and WNT (n=70; 41% male). Females had worse survival than males for SHH (p-value=0.02). DMPs by sex were identified within subgroups: SHH (n=131), Group 4 (n=29), Group 3 (n=19), and WNT (n=16) and validated in an independent dataset. Unsupervised hierarchical clustering showed that sex-DMPs in SHH did not correlate with other tumor attributes. Ten genes with sex DMPs (RFTN1, C1orf103, FKBP1B, COL25A1, NPDC1, B3GNT1, FOXN3, RNASEH2C, TLE1, and PHF17) were shared across subgroups. Significant pathways (p
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- 2023
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12. Mitral Valve Transcatheter Edge-to-Edge Repair Volumes and Trends
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Kris Kumar, Timothy F. Simpson, Harsh Golwala, Adnan K. Chhatriwalla, Scott M. Chadderdon, Robert L. Smith, Howard K. Song, Ryan R. Reeves, Paul Sorajja, and Firas E. Zahr
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Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Background. Despite an association between operator volumes and procedural success, there remains an incomplete understanding of the contemporary utilization and procedural volumes for mitral valve transcatheter edge-to-edge repair (MTEER). We aimed to identify annual operator procedural volumes, temporal trends, and geographic variability for MTEER among Medicare patients in the United States (US). Methods. We queried the National Medicare Provider Utilization and Payment Database for a CPT code (33418) specific for MitraClip device from 2015 through 2019. We analyzed annual operator procedural volumes and incidence and identified longitudinal and geographic trends in MTEER utilization. Results. From 2015 through 2019, a total of 27,034 MTEER procedures were performed among Medicare patients in the US. The nationwide incidence increased from 6.2 per 100,000 patients in 2015 to 23.8 per 100,000 patients in 2019, a 283% increase over the study period (Ptrend
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- 2023
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13. Use of Flecainide in Stable Coronary Artery Disease: An Analysis of Its Safety in Both Nonobstructive and Obstructive Coronary Artery Disease
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Ashraf, Hasan, Ko, Nway Ko, Ladia, Vatsal, Agasthi, Pradyumna, Prendiville, Tadhg, O’Herlihy, Fergus, Pujari, Sai Harika, Mulpuru, Siva K., Scott, Luis, and Sorajja, Dan
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- 2021
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14. Three-Year Outcomes Following TAVR in Younger (<75 Years) Low-Surgical-Risk Severe Aortic Stenosis Patients.
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Modine T, Tchétché D, Van Mieghem NM, Deeb GM, Chetcuti SJ, Yakubov SJ, Sorajja P, Gada H, Mumtaz M, Ramlawi B, Bajwa T, Crouch J, Teirstein PS, Kleiman NS, Iskander A, Bagur R, Chu MWA, Berthoumieu P, Sudre A, Adrichem R, Ito S, Huang J, Popma JJ, Forrest JK, and Reardon MJ
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- Humans, Male, Female, Aged, Treatment Outcome, Risk Factors, Time Factors, Risk Assessment, Age Factors, Middle Aged, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation mortality, Heart Valve Prosthesis Implantation instrumentation, Prosthesis Design, Bioprosthesis, Aortic Valve Stenosis surgery, Aortic Valve Stenosis mortality, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis physiopathology, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement mortality, Transcatheter Aortic Valve Replacement instrumentation, Aortic Valve surgery, Aortic Valve diagnostic imaging, Aortic Valve physiopathology, Severity of Illness Index, Heart Valve Prosthesis, Stroke mortality, Stroke etiology
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Background: Transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis, but data are limited on younger, low-risk patients. This analysis compares outcomes in low-surgical-risk patients aged <75 years receiving TAVR versus surgery., Methods: The Evolut Low Risk Trial randomized 1414 low-risk patients to treatment with a supra-annular, self-expanding TAVR or surgery. We compared rates of all-cause mortality or disabling stroke, associated clinical outcomes, and bioprosthetic valve performance at 3 years between TAVR and surgery patients aged <75 years., Results: In patients <75 years, 352 were randomized to TAVR and 351 to surgery. Mean age was 69.1±4.0 years (minimum 51 and maximum 74); Society of Thoracic Surgeons Predicted Risk of Mortality was 1.7±0.6%. At 3 years, all-cause mortality or disabling stroke for TAVR was 5.7% and 8.0% for surgery ( P =0.241). Although there was no difference between TAVR and surgery in all-cause mortality, the incidence of disabling stroke was lower with TAVR (0.6%) than surgery (2.9%; P =0.019), while surgery was associated with a lower incidence of pacemaker implantation (7.1%) compared with TAVR (21.0%; P <0.001). Valve reintervention rates (TAVR 1.5%, surgery 1.5%, P =0.962) were low in both groups. Valve performance was significantly better with TAVR than surgery with lower mean aortic gradients ( P <0.001) and lower rates of severe prosthesis-patient mismatch ( P <0.001). Rates of valve thrombosis and endocarditis were similar between groups. There were no significant differences in rates of residual ≥moderate paravalvular regurgitation., Conclusions: Low-risk patients <75 years treated with supra-annular, self-expanding TAVR had comparable 3-year all-cause mortality and lower disabling stroke compared with patients treated with surgery. There was significantly better valve performance in patients treated with TAVR., Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT02701283., Competing Interests: Dr Modine is a consultant and Senior Advisory Board member for Medtronic. Dr Tchétché is a consultant for Medtronic. Dr Van Mieghem receives grants from Medtronic during the conduct of the trial and grants from Abbott Vascular, Edwards Lifesciences, Boston Scientific, Abiomed, PulseCath BV, and Daiichi Sankyo outside the submitted work. Dr Chetcuti receives personal fees from Medtronic; grants from Edwards, Boston Scientific, and Jena (paid to institution) during conduct of trial; and on an advisory board for Biotrace and Jena valve without remuneration. Dr Yakubov receives grants from Boston Scientific and Medtronic (paid to institution) and personal fees from Medtronic during the conduct of the trial. Dr Sorajja is a consultant to Boston Scientific and Medtronic. Dr Gada receives personal fees from Medtronic, Abbott Vascular, Becton Dickenson, and Boston Scientific outside the submitted work. Dr Mumtaz is a consultant and has received honoraria and research grants from Medtronic, Edwards, Atricure, Teleflex, Foldax, Japanese Organization for Medical Device Development, and Abbott. Dr Ramlawi receives grants, personal fees, and nonfinancial support from Medtronic, Liva Nova, and AtriCure. Dr Bajwa is a consultant for Medtronic. Dr Teirstein receives research grant and honoraria from Abbott, Boston Scientific, Cordis, and Medtronic, and serves on an advisory board for Boston Scientific and Medtronic. Dr Kleiman receives clinical trial reimbursement to his institution (Houston Methodist DeBakey Heart and Vascular Center) during the conduct of the trial. Dr Bagur serves as a consultant for Medtronic. Dr Chu receives Speakers’ honoraria from Medtronic, Edwards Lifesciences, Terumo Aortic and Artivion. Dr Huang is an employee and shareholder of Medtronic, plc. Dr Popma is a full-time employee and shareholder for Medtronic. Dr Forrest receives grant support/research contracts and consultant fees/honoraria/Speakers Bureau fees from Edwards Lifesciences and Medtronic. Dr Reardon receives grants from Medtronic (paid to institution) during conduct of trial, and consulting fees from Abbott, Boston Scientific, and Gore Medical (paid to institution) outside of the submitted work. The other authors report no conflicts.
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- 2024
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15. Biventricular reverse-remodeling after transcatheter mitral valve replacement with the Tendyne™ system.
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Fukui M, Sorajja P, Muller DW, Walser-Kuntz E, Stanberry LI, Babaliaros VC, Thourani VH, Dumonteil N, Walters D, Dahle G, Grayburn PA, Eng MH, Chuang ML, Sun B, Blanke P, Duncan A, and Cavalcante JL
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Competing Interests: Declaration of competing interest Dr. Cavalcante has received consulting fees from 4C Medical, Abbott Structural, Anteris, AriaCV, Boston Scientific, Edwards Lifesciences, HighLife, Medtronic, VDyne, WL Gore, Xylocor; has received research grant support from Abbott Northwestern Hospital Foundation; Dr. Sorajja has received consulting fees from 4C Medical, Abbott Structural, Adona, Boston Scientific, Cultiv8, Edwards Lifesciences, Foldax, GE Medical, GLG, LAZA, Medtronic, Phillips, WL Gore, vDyne, xDot; Dr. Muller has received consulting fees from Medtronic, Edwards Lifesciences, Abbott structure; has received research grants from Medtronic, Abbott structure, HighLife Medical; Dr. Babaliaros has received consulting fees from Edwards Lifesciences; Dr. Dumonteil has received consulting fees from Abbott structure, Boston Scientific, Edwards LifeSciences and Medtronic; Dr Dahle has received consulting fee from Abbott Structural; Dr. Grayburn has received consulting fee from Abbott Vascular, Edwards Lifesciences, Medtronic, and 4C Medical; Dr. Eng has received consulting fees from Edwards Lifesciences and Medtronic; Dr. Blanke has received consulting fees from Edwards Lifesciences and Laralab; Dr. Duncan has received consulting fees from Abbott Vascular, Edwards LifeSciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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- 2024
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16. Advanced Imaging Assessment of the Impact of Tricuspid Regurgitation on Cardiac Remodeling: The TRILUMINATE Pivotal Imaging Substudy.
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Cavalcante JL, Scherer M, Fukui M, Lerakis S, Harb S, Pursnani A, Schwartz JG, Kapadia S, Ricciardi MJ, Khalique O, Kodali S, Shah D, Little SH, Sekaran N, Whisenant B, Flueckiger P, Yadav P, Emaminia A, Batchelor W, Kellman P, Lin Z, Trusty PM, Hahn RT, Adams D, and Sorajja P
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Background: The impact of tricuspid regurgitation (TR) on cardiac remodeling has not been thoroughly studied in a randomized controlled trial using advanced imaging., Objectives: The goal of this analysis was to provide comparative longitudinal changes in right heart remodeling using cardiac magnetic resonance and time-resolved functional computed tomography (4D-CT) in patients with symptomatic severe TR randomized to TriClip vs medical therapy (control)., Methods: TRILUMINATE Pivotal (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal) is an international randomized controlled trial in symptomatic patients with severe TR. A prospective imaging substudy was performed on TRILUMINATE Pivotal subjects at 10 sites. Cardiac magnetic resonance and 4D-CT were performed following dedicated imaging protocols at baseline and at 30 days, and a final 4D-CT at 1 year (all assessed by an imaging core lab)., Results: Sixty-nine randomized subjects (31 TriClip, 38 control) were enrolled. TR volume significantly decreased with TriClip at 30 days (P < 0.0001; 70% reduction). A strong association (r = 0.90; P < 0.0001) was observed between changes in TR volume and right ventricular end-diastolic volume at 30 days. Significant reductions in right ventricular end-diastolic volume (12% reduction; P < 0.001) and tricuspid annular area (11% reduction; P < 0.0001) were seen at 30 days and sustained through 1 year with TriClip. No meaningful changes were observed in the control group., Conclusions: Advanced imaging from the TRILUMINATE Pivotal imaging substudy demonstrated that TriClip effectively reduced TR. Significant cardiac remodeling was observed at 30 days and sustained at 1 year. With TriClip, the extent of cardiac remodeling was associated with the degree of TR reduction. (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal; NCT03904147)., Competing Interests: Funding Support and Author Disclosures This study was funded by Abbott. Dr Cavalcante has received consulting fees from 4C Medical, Abbott, Alleviant, Anteris, Boston Scientific, Circle Cardiovascular Imaging, Edwards Lifesciences, JenaValve, JC Medical, Medtronic, Novo Nordisk, Pie Medical, Siemens Healthineers, Shockwave, and Zoll; and has received research grant support Abbott Structural, Allina Health Foundation, JenaValve, and National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI). Dr Scherer has received consulting/speaker fees/honoraria from Abbott, Boston Scientific, Edwards Lifesciences, HeartFlow, Philips, and Siemens; and has received institutional grant/research support from Boston Scientific and HeartFlow. Dr Fukui has served as a consultant for Edwards Lifesciences and Anteris. Dr Harb has served as a speaker for Edwards Lifesciences; and has served as a consultant and speaker for Abbott, Boston Scientific, and TeraRecon. Dr Schwartz has served as a consultant for Abbott, Boston Scientific, Cordis, Edwards Lifesciences, Medtronic, and Phillips. Dr Ricciardi has received consultant and speaker fees from Abbott. Dr Khalique has received consulting fees from Siemens, Philips, Edwards, Croivalve, Triflo, and Restore Medical. Dr Kodali has received grant/research support from Boston Scientific, Edwards Lifesciences, and Medtronic; has received consulting fees/honoraria from Ancora Heart Inc, Aria CV Inc, Dura Biotech, Thubrikar Aortic Valve Inc, and Valfix Medical; and has owned equity from Admedus Regen Pty Ltd., Dura Biotech, Supira Medical, and Trisol Medical. Dr Whisenant has received consulting fees/honoraria from Abbott and Edwards Lifesciences. Dr Yadav is a consultant/speaker for Edwards Lifesciences, Abbott Vascular, Boston Scientific, and Medtronic; is on the Medical Advisory Board of Dasi Simulations, Trisol, and Opus; and has equity in Dasi Simulations and Opus. Dr Emaminia has received consultant fees from Abbott. Dr Batchelor has consulted for Abbott, Edwards, Boston Scientific, and Medtronic; and has received research support from Abbott and Boston Scientific. Dr Lin is an employee of Abbott. Dr Trusty is an employee of Abbott. Dr Hahn has served as a speaker for Abbott, Baylis Medical, Edwards Lifesciences, and Philips. Dr Adams has served as the national coprincipal investigator of Abbott TRILUMINATE Pivotal Trial, Medtronic APOLLO US Pivotal Trial, ReChord US Pivotal Trial, and Medtronic CoreValve US Pivotal Trial. Dr Sorajja has served as a consultant for Boston Scientific, Edwards Lifesciences, Evolution Medical, Medtronic, Shifamed, TriFlo, and WL Gore; has served as a member of the advisory board for VDyne and Anteris; and has served as the principal investigator of clinical trials for Abbott and HighLife. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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17. Tricuspid transcatheter edge-to-edge repair for severe tricuspid regurgitation: 1-year outcomes from the TRILUMINATE randomized cohort.
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Tang GHL, Hahn RT, Whisenant BK, Hamid N, Naik H, Makkar RR, Tadros P, Price MJ, Singh GD, Fam NP, Kar S, Mehta SR, Bae R, Sekaran NK, Warner T, Makar M, Zorn G, Benza R, Jorde UP, McCarthy PM, Thourani VH, Ren Q, Trusty PM, Sorajja P, and Adams DH
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Background: Tricuspid regurgitation (TR) is a right-sided valvular disease independently associated with morbidity and mortality. The TRILUMINATE Pivotal trial is the first randomized, controlled trial assessing the impact of TR reduction with tricuspid transcatheter edge-to-edge repair (T-TEER)., Objective: Outcomes from the full randomized cohort of the TRILUMINATE Pivotal trial have not been previously reported, and the additional enrollment may further support the safety and effectiveness of T-TEER through 1 year., Methods: The TRILUMINATE Pivotal trial is an international RCT of T-TEER with the TriClip device in patients with symptomatic, severe TR. Adaptive trial design allowed enrollment past the primary analysis population. The primary outcome was a hierarchical composite of all-cause mortality or tricuspid valve surgery, heart failure hospitalizations (HFH), and quality-of-life improvement measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 1 year., Results: Between August 21, 2019 and June 29, 2022, 572 subjects were randomized, including the primary cohort (n=350) and subsequent enrollment (n=222). Subjects were elderly (78.1±7.8 years) and predominantly female (58.9%), with atrial fibrillation (87.8%) and prior HFH (23.8%). The primary endpoint was met for the full cohort (win ratio=1.84, p<0.0001). Freedom from all-cause mortality and tricuspid valve surgery through 12 months was 90.6% and 89.9% for the device and control groups, respectively (p=0.82). Annualized HFH rate was comparable between device and control subjects (0.17 vs 0.20 events/patient-year, p=0.40). A significant treatment effect was observed for change in quality of life with 49.5% of device subjects achieving a ≥15-point KCCQ score improvement (compared to 25.6% of control subjects, p<0.0001). All secondary endpoints favored T-TEER: moderate or less TR at 30 days (88.9% vs 5.3%, p<0.0001), KCCQ change at 1 year (13.0±1.4 vs -0.5±1.4 points, p<0.0001), and six-minute walk distance change at 1 year (1.7±7.5 vs -27.4±7.4 meters, p<0.0001). Freedom from major adverse events was 98.9% for T-TEER (vs. performance goal: 90%, p<0.0001)., Conclusions: TriClip was safe and effective in the full randomized cohort of TRILUMINATE Pivotal with significant TR reduction and improvements in six-minute walk distance and health status. Rates of all-cause mortality or TV surgery and HFH through 1 year were not reduced by T-TEER., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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18. Percutaneous Edge-to-Edge Repair for Tricuspid Regurgitation: 3-Year Outcomes From the TRILUMINATE Study.
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Nickenig, Georg, Lurz, Philipp, Sorajja, Paul, von Bardeleben, Ralph Stephan, Sitges, Marta, Tang, Gilbert H.L., Hausleiter, Jörg, Trochu, Jean-Noel, Näbauer, Michael, Heitkemper, Megan, Ying, Shih-Wa, Weber, Marcel, and Hahn, Rebecca T.
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- 2024
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19. In Vivo Computed Tomography Sizing for Redo-Transcatheter Aortic Valve Replacement in Evolut Valves: Impact on Sizing, Feasibility, and Prosthesis-Patient Mismatch.
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Atsushi Okada, Miho Fukui, Zaid, Syed, Thao, Kiahltone R., Walser-Kuntz, Evan, Stanberry, Larissa I., Burns, Marcus R., Hideki Koike, Cheng Wang, Phichaphop, Asa, Lesser, John R., Cavalcante, João L., Sorajja, Paul, and Bapat, Vinayak N.
- Abstract
BACKGROUND: SAPIEN3 (S3) is a ubiquitous redo-transcatheter aortic valve (TAV) replacement alternative for degenerated Evolut valves, but S3 sizing for S3-in-Evolut remains unclear. We sought to compare the impact of in vivo computed tomography (CT)-sizing on redo-TAV feasibility for S3-in-Evolut with traditional bench-sizing. METHODS: CT scans of 290 patients treated using Evolut R/PRO/PRO+ between July 2015 and December 2021 were analyzed. S3-in-Evolut was simulated using S3 outflow/neoskirt plane (NSP) at node-6, -5, and -4. CT-sizing for S3 was determined by averaging 4 areas of the Evolut stent frame at NSP level and 3 nodes below. Redo-TAV was deemed feasible if the NSP was below the coronaries, or the narrowest valve (virtual S3)-to-aorta distance was >4 mm. Risk of prosthesis-patient mismatch was estimated using predicted indexed-effective orifice area. RESULTS: Compared with bench-sizing, CT-sizing yielded smaller S3 size in 82% at node-6, 81% at node-5, and 84% at node-4. Factors associated with CT-sizing less than bench-sizing were larger index Evolut size, underexpansion of index Evolut, and shallower implant depth (all P<0.05). CT-sizing increased redo-TAV feasibility by +8% at node-6, +10% at node-5, and +4% at node-4. Redo-TAV feasibility increased with annulus size, sinotubular junction dimensions, coronary heights, index Evolut size, deeper Evolut implant depth, and lower NSP levels (all P<0.05). CT-sizing had a slightly higher estimated risk of severe prosthesis-patient mismatch (9% at node-6, 7% at node-5, and 6% at node-4), which could be mitigated by changing the NSP. CONCLUSIONS: CT-sizing for S3-in-Evolut is associated with higher feasibility of redo-TAV compared with bench-sizing, potentially reducing the risk of excessive oversizing and S3 underexpansion. Further validation using real-world clinical data is necessary. [ABSTRACT FROM AUTHOR]
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- 2024
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20. Empirical Ablation to Prevent Sequential Purkinje System Recruitment
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Pattara Rattanawong, MD, Vatsal Ladia, MBBS, MD, MHA, Nareg Minaskeian, MD, Dan Sorajja, MD, Win-Kuang Shen, MD, and Komandoor S. Srivathsan, MD
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ablation ,idiopathic ventricular fibrillation ,sudden cardiac death ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
We report 3 cases (mean age 48.3 ± 11.6 years) of idiopathic ventricular fibrillation (IVF), in which a triggering premature ventricular complex leading to IVF could not be identified. All patients underwent posterior fascicle transection with empirical linear ablation of the mid-Purkinje potentials identified along the left ventricular interventricular inferior septum, and no ventricular fibrillation recurrence was documented in any of the patients. (Level of Difficulty: Advanced.)
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- 2021
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21. Natural history and clinical significance of isolated complete left bundle branch block without associated structural heart disease
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Hasan Ashraf, Pradyumna Agasthi, Robert J. Siegel, Sai Harika Pujari, Mohamed Allam, Win Kuang Shen, Komandoor Srivathsan, Dan Sorajja, Hicham El Masry, William K. Freeman, Farouk Mookadam, Siva Mulpuru, and Reza Arsanjani
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Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Published
- 2021
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22. Natural history observations in moderate aortic stenosis
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Yu Du, Mario Gössl, Santiago Garcia, Maurice Enriquez-Sarano, Joao L. Cavalcante, Richard Bae, Go Hashimoto, Miho Fukui, Bernardo Lopes, Aisha Ahmed, Christian Schmidt, Larissa Stanberry, Ross Garberich, Steven M. Bradley, Robert Steffen, and Paul Sorajja
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Moderate ,Aortic stenosis ,Outcomes ,Survival ,Aortic valve replacement ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Abstract Background The natural history of patients with moderate aortic stenosis (AS) is poorly understood. We aimed to determine the long-term outcomes of patients with moderate AS. Methods We examined patients with moderate AS defined by echocardiography in our healthcare system, and performed survival analyses for occurrence of death, heart failure (HF) hospitalization, and progression of AS, with accounting for symptoms, left ventricular dysfunction, and comorbidities. Results We examined 729 patients with moderate AS (median age, 76 years; 59.9 % men) with a median follow-up of 5.0 years (interquartile range: 2.0 to 8.1 years). The 5-year overall survival was 52.3 % (95 % confidence interval [CI]: 48.6 % to 56.0 %) and survival free of death or HF hospitalization was 43.2 % (95 % CI: 39.5 % to 46.9 %). Worse New York Heart Association (NYHA) functional class was associated with poor long-term survival, with mortality rates ranging from 7.9 % (95 % CI: 6.6–9.2 %) to 25.2 % (95 % CI: 20.2–30.3 %) per year. Among patients with minimal or no symptoms, no futility markers, and preserved left ventricular function, 5-year overall survival was 71.9 % (95 % CI: 66.4–77.4 %) and survival free of death or HF hospitalization was 61.4 % (95 % CI: 55.5–67.3 %). Risk factors associated with adverse events were age, NYHA class, low ejection fraction and high aortic valve velocity (all p
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- 2021
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23. Computed Tomography Planning for Transcatheter Mitral Valve Replacement
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Go Hashimoto, MD, Bernardo B.C. Lopes, MD, Hirotomo Sato, MD, PhD, Miho Fukui, MD, PhD, Santiago Garcia, MD, Mario Gössl, MD, PhD, Maurice Enriquez-Sarano, MD, Paul Sorajja, MD, Vinayak N. Bapat, MD, John Lesser, MD, and João L. Cavalcante, MD
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MDCT ,Mitral regurgitation ,TMVR ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Transcatheter mitral valve replacement (TMVR) is a rapidly evolving treatment for mitral regurgitation. As with transcatheter aortic valve replacement, multidetector computed tomography analysis plays a central role in defining the candidacy, device selection and safety for TMVR procedures. This contemporary review will describe in detail the multidetector computed tomography data collection, analysis, and planning for TMVR procedures in patients with native mitral regurgitation as well as in those with failed surgical prosthetic mitral valve replacement or surgical mitral valve repair.
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- 2022
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24. Multicenter Clinical Management Practice to Optimize Outcomes Following Tendyne Transcatheter Mitral Valve Replacement
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Alison Duncan, FRCP, PhD, Gry Dahle, MD, PhD, Lenard Conradi, MD, Nicholas Dumonteil, MD, John Wang, MD, Nimesh Shah, MD, Benjamin Sun, MD, Paul Sorajja, MD, Gorav Ailawadi, MD, Jason H. Rogers, MD, Cesare Quarto, PhD, FRCS, and Brian Bethea, MD
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Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Published
- 2022
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25. Left atrial to coronary sinus shunting for treatment of heart failure with mildly reduced or preserved ejection fraction: The ALT FLOW Early Feasibility Study 1-year results.
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Urey MA, Hibbert B, Jorde U, Eckman P, Simard T, Labinaz M, Nazer B, Wiley M, Gupta B, Sauer A, Shah H, Sorajja P, Pineda AM, Missov E, Mahmud E, Kahwash R, Lilly S, Latib A, Murthy S, Fam N, Garcia S, Chung ES, Klein L, Cheng R, Houston BA, Amoroso NS, Chang L, Gafoor S, Chaudhry SP, Hermiller J, Schwartz JG, Aldaia L, Koulogiannis K, Gray WA, and Zahr F
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- Humans, Female, Male, Aged, Treatment Outcome, Middle Aged, Echocardiography methods, Quality of Life, Cardiac Catheterization methods, Prospective Studies, Ventricular Function, Left physiology, Follow-Up Studies, Hemodynamics physiology, Heart Failure physiopathology, Heart Failure surgery, Heart Failure therapy, Feasibility Studies, Stroke Volume physiology, Heart Atria physiopathology, Heart Atria diagnostic imaging, Coronary Sinus physiopathology
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Aims: Patients with heart failure and mildly reduced or preserved ejection fraction have limited therapeutic options. The ALT-FLOW Early Feasibility Study evaluated safety, haemodynamics and outcomes for the APTURE transcatheter shunt system, a novel left atrium to coronary sinus shunt in these patients., Methods and Results: Safety and shunt implantation success was evaluated for all 116 enrolled patients. An analysis population of implanted patients with a left ventricular ejection fraction (LVEF) >40% (n = 95) was chosen to assess efficacy via paired comparison between baseline and follow-up haemodynamic (3 and 6 months), and echocardiographic, clinical and functional outcomes (6 months and 1 year). Health status and quality of life outcomes were assessed using the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS). The primary safety endpoint, major adverse cardiac, cerebral, and renal events, and reintervention through 30 days, occurred in 3/116 patients (2.6%). All implanted shunts were patent at 1 year. In patients with LVEF >40%, the mean (95% confidence interval) reduction in exercise pulmonary capillary wedge pressure (PCWP) at 20 W was -5.7 (-8.6, -2.9) mmHg at 6 months (p < 0.001). At baseline, 8% had New York Heart Association class I-II status and improved to 68% at 1 year (p < 0.001). KCCQ-OSS at baseline was 39 (35, 43) and improved at 6 months and 1 year by 25 (20-30) and 27 (22-32) points, respectively (both p < 0.0001). No adverse changes in haemodynamic and echocardiographic indices of right heart function were observed at 1 year. Overall, the reduction in PCWP at 20 W and improvement in KCCQ-OSS in multiple subgroups were consistent with those observed for the entire population., Conclusions: In patients with heart failure and LVEF >40%, the APTURE shunt demonstrated an acceptable safety profile with significant sustained improvements in haemodynamic and patient-centred outcomes, underscoring the need for further evaluation of the APTURE shunt in a randomized trial., (© 2024 European Society of Cardiology.)
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- 2024
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26. Wide QRS complex and the risk of major arrhythmic events in Brugada syndrome patients: A systematic review and meta‐analysis
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Pattara Rattanawong, Jakrin Kewcharoen, Chol Techorueangwiwat, Chanavuth Kanitsoraphan, Raktham Mekritthikrai, Narut Prasitlumkum, Prapaipan Puttapiban, Poemlarp Mekraksakit, Wasawat Vutthikraivit, and Dan Sorajja
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Brugada syndrome ,Major arrhythmic events ,wide QRS ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Abstract Background Brugada syndrome (BrS) is an inherited arrhythmic disease associated with an increased risk of major arrhythmic events (MAE). Previous studies reported that a wide QRS complex may be useful as a predictor of MAE in BrS patients. We aimed to assess the correlation of wide QRS complex with MAE by a systematic review and meta‐analysis. Methods We comprehensively searched the databases of MEDLINE and EMBASE from inception to June 2019. Included studies were cohort and case control studies that reported QRS duration and the relationship between wide QRS complex (>120 milliseconds) and MAE (sudden cardiac death, sudden cardiac arrest, ventricular fibrillation, sustained ventricular tachycardia, or appropriate shock). Data from each study were combined using the random‐effects model. Results Twenty‐two studies from 2007 to 2018 were included in this meta‐analysis involving 4,814 BrS patients. The mean age was 46.1 ± 12.8 years. The patients were predominately men (77.6%). Wide QRS duration was an independent predictor of MAE (pooled risk ratio 1.55, 95% confidence interval: 1.04‐2.30, P = .30, I2 = 38.4%). QRS duration was wider in BrS who had history of MAE (weight mean difference = 8.12 milliseconds, 95% confidence interval: 5.75‐10.51 milliseconds). Conclusions Our study demonstrated that QRS duration is wider in BrS who had history of MAE, and a wide QRS complex is associated with 1.55 times higher risk of MAE in BrS populations. Wide QRS complex can be considered for risk stratification in prediction of MAE in patients with BrS, especially when considering implantable cardioverter‐defibrillator placement in asymptomatic patients.
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- 2020
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27. Transcatheter Left Ventricular Restoration in Patients With Heart Failure
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Hamid, NADIRA, JORDE, ULRICH P., REISMAN, M. A.R.K., LATIB, AZEEM, LIM, D. SCOTT, JOSEPH, SUSAN M., KURLIANSKAYA, ALENA, POLONETSKY, O. L.E.G., NEUZIL, P. E.T.R., REDDY, VIVEK, FOERST, JASON, GADA, HEMAL, GRUBB, KENDRA J., SILVA, GUILHERME, KEREIAKES, D. E.A.N., SHREENIVAS, SATYA, PINNEY, S. E.A.N., DAVIDAVICIUS, GIEDRIUS, SORAJJA, P. A.U.L., BOEHMER, JOHN P., KLEBER, FRANZ X., PERIER, PATRICK, VAN MIEGHEM, NICOLAS M., DUMONTEIL, NICOLAS, LEON, MARTIN B., BURKHOFF, DANIEL, Hamid, NADIRA, JORDE, ULRICH P., REISMAN, M. A.R.K., LATIB, AZEEM, LIM, D. SCOTT, JOSEPH, SUSAN M., KURLIANSKAYA, ALENA, POLONETSKY, O. L.E.G., NEUZIL, P. E.T.R., REDDY, VIVEK, FOERST, JASON, GADA, HEMAL, GRUBB, KENDRA J., SILVA, GUILHERME, KEREIAKES, D. E.A.N., SHREENIVAS, SATYA, PINNEY, S. E.A.N., DAVIDAVICIUS, GIEDRIUS, SORAJJA, P. A.U.L., BOEHMER, JOHN P., KLEBER, FRANZ X., PERIER, PATRICK, VAN MIEGHEM, NICOLAS M., DUMONTEIL, NICOLAS, LEON, MARTIN B., and BURKHOFF, DANIEL
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Background: Left ventricular (LV) volume reshaping reduces myocardial wall stress and may induce reverse remodeling in patients with heart failure with reduced ejection fraction. The AccuCinch Transcatheter Left Ventricular Restoration system consists of a series of anchors connected by a cable implanted along the LV base that is cinched to the basal free wall radius. We evaluated the echocardiographic and clinical outcomes following transcatheter left ventricular restoration. Methods and Results: We analyzed 51 heart failure patients with a left ventricular ejection fraction between 20% and 40%, with no more than 2+ mitral regurgitation treated with optimal medical therapy, who subsequently underwent transcatheter left ventricular restoration. Serial echocardiograms, Kansas City Cardiomyopathy Questionnaire scores, and 6-minute walk test distances were measured at baseline through 12 months. Primary analysis end point was change in end-diastolic volume at 12 months compared with baseline. Patients (n = 51) were predominantly male (86%) with a mean age of 56.3 ± 13.1 years. Fluoroscopy showed LV free wall radius decreased by a median of 9.2 mm amounting to a 29.6% decrease in the free wall arc length. At 12 months, the LV end-diastolic volume decreased by 33.6 ± 34.8 mL (P < .01), with comparable decreases in the LV end-systolic volume. These decreases were associated with significant improvements in the overall Kansas City Cardiomyopathy Questionnaire score (16.4 ± 18.7 points; P < .01) and 6-minute hall walk test distance (45.9 ± 83.9 m; P < .01). There were no periprocedural deaths; through the 1-year follow-up, 1 patient died (day 280) and 1 patient received a left ventricular assist device (day 13). Conclusions: In patients with heart failure with reduced ejection fraction without significant mitral regurgitation receiving optimal medical therapy, the AccuCinch System resulted in decreases of LV volume, as well as improved quality of life and exerci
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- 2023
28. Natural history observations in moderate aortic stenosis
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Du, Yu, Gössl, Mario, Garcia, Santiago, Enriquez-Sarano, Maurice, Cavalcante, Joao L., Bae, Richard, Hashimoto, Go, Fukui, Miho, Lopes, Bernardo, Ahmed, Aisha, Schmidt, Christian, Stanberry, Larissa, Garberich, Ross, Bradley, Steven M., Steffen, Robert, and Sorajja, Paul
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- 2021
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29. Incidence, Predictors, and Outcomes of Unplanned Coronary Angiography After Transcatheter Aortic Valve Replacement.
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Phichaphop A, Okada A, Fukui M, Koike H, Wang C, Margonato D, Walser-Kuntz E, Stanberry LI, Hamid N, Cavalcante JL, Enriquez-Sarano M, Lesser JR, Bapat VN, and Sorajja P
- Abstract
Background: Assessment of coronary artery disease (CAD) is critical in managing severe aortic stenosis. Unplanned coronary angiography after TAVR, with or without percutaneous coronary intervention, may present significant challenges., Objectives: The aim of this study was to evaluate the incidence, predictors, and outcomes of unplanned coronary angiography after transcatheter aortic valve replacement (TAVR)., Methods: All TAVR procedures between July 2015 and December 2021 were examined for the occurrence of unplanned angiography and for procedural success with percutaneous coronary intervention if attempted, and a machine learning prediction model was created., Results: Among 1,444 patients (median age 81 years, 59% men), 6.7% had unplanned post-TAVR angiography, 45% within the first year. The most common indication was acute coronary syndrome, which occurred in 3.3% overall. Patients with preprocedural CAD (50.1%) had a significantly higher incidence of unplanned angiography (10.5% vs 2.9%; P < 0.001) in comparison with others. In multivariable analysis, factors associated with unplanned angiography were age (>75 years; HR: 0.46; 95% CI: 0.30-0.71; P < 0.001), mean aortic valve gradient (HR: 0.82; 95% CI: 0.68-0.98; P = 0.031), dialysis (HR: 2.68; 95% CI: 1.07-6.74; P = 0.036), and CAD (HR: 2.96; 95% CI: 1.76-4.98; P < 0.001). In multivariate models, these same variables had areas under the curve of 0.71 to 0.77 for 5-year prediction of unplanned angiography., Conclusions: Unplanned angiography post-TAVR occurs in about 1 in 15 patients, with about one-half occurring within the first year, about one-half due to acute coronary syndrome, and pre-existing CAD being the strongest predictor. For those considering TAVR and who have or are at risk for CAD, a comprehensive strategy to facilitate lifetime management is needed., Competing Interests: Funding Support and Author Disclosures Dr Sorajja has received consulting fees from 4C Medical, Abbott Structural, Adona, Boston Scientific, Edwards Lifesciences, Foldax, GE Medical, Laza, Medtronic, Philips, VDYNE, WL Gore, and xDot. Dr Cavalcante has received consulting fees from 4C Medical, Abbott Structural, Alleviant, Anteris, Boston Scientific, Circle Cardiovascular Imaging, Edwards Lifesciences, JenaValve, JC Medical, Medtronic, Novo Nordisk, Pie Medical, Siemens Healthineers, Shockwave, Zoll. Dr Hamid has received consulting fees from Abbott Structural, AMX, 4C medical technologies, Alleviant Medical, Edwards Lifesciences, JenaValve, Philips, GE, Vdyne, WL Gore, xDot. Dr Enriquez-Sarano has received consulting fees from Cryolife, Edwards Lifescience, Highlife, and ChemImage. Dr Bapat has received consulting fees from Abbott Structural, Anteris, Boston Scientific, Edwards Lifesciences, and Medtronic. All other authors have reported that they have no relationship relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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30. Impact of Renal and Liver Function on Clinical Outcomes Following Tricuspid Valve Transcatheter Edge-to-Edge Repair.
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Jorde UP, Benza R, McCarthy PM, Ailawadi G, Whisenant B, Makkar R, Tadros P, Naik H, Fam N, Sauer AJ, Murthy S, Kar S, von Bardeleben RS, Hahn RT, Hamid N, Zbinden J, Sorajja P, and Adams D
- Abstract
Background: The TRILUMINATE Pivotal trial is a prospective, randomized, controlled study of patients with severe tricuspid regurgitation (TR). Venous congestion due to TR may lead to end-organ dysfunction and failure. The potential to reverse or stop further deterioration in end-organ function is an important goal of treatment., Objectives: This study sought to examine changes in end-organ function after tricuspid transcatheter edge-to-edge repair (TEER) and assess the association of baseline end-organ function with heart failure (HF) hospitalizations and mortality., Methods: Subjects were randomized 1:1 to either the TEER group (TriClip System + medical therapy) or control group (medical therapy alone). Laboratory assessments and TR grading were performed at baseline and at all follow-up visits (discharge, 30 days, 6 months, and 12 months). An independent echocardiography core laboratory assessed TR severity and an independent clinical events committee adjudicated adverse events., Results: A total of 572 subjects were enrolled and randomized (285 TEER, 287 control patients). Patients with moderate-to-severe end-organ impairment (estimated glomerular ejection fraction [eGFR] <45 mL/min/1.73 m
2 or Model for End-Stage Liver Disease excluding INR [MELD-XI] >15) at baseline had increased incidence of HF hospitalization and death through 12 months, regardless of treatment. There were no statistically significant differences between TEER and control patients in eGFR or MELD-XI at 12 months. In subgroup analyses examining only successful TEER patients (moderate or less TR at discharge) compared with control patients, as well as when censoring patients with normal baseline values, both eGFR (+3.55 ± 1.04 mL/min/1.73 m2 vs 0.07 ± 1.10 mL/min/1.73 m2 ; P = 0.022) and MELD-XI (-0.52 ± 0.18 vs 0.34 ± 0.18; P = 0.0007) improved., Conclusions: Baseline end-organ function was associated with HF hospitalization and death in patients with severe TR. At 12 months, eGFR and MELD-XI scores were not statistically significantly different between the overall TEER and control groups. In patients who had successful TEER, statistically significant, yet small, favorable changes occurred for both eGFR and MELD-XI. Further investigation is needed to assess whether these changes in end-organ function after successful TEER are clinically meaningful and reduce HF hospitalization or death. (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal [TRILUMINATE Pivotal]; NCT03904147)., Competing Interests: Funding Support and Author Disclosures The TRILUMINATE Pivotal trial was funded and sponsored by Abbott. Dr Jorde has received consulting fees from Abbott and Edwards Lifesciences. Dr Benza has received consulting fees from Abbott and Bayer HealthCare Pharmaceuticals Inc; and has been an endpoint review committee member for United Therapeutics. Dr McCarthy has been a coprincipal investigator of REPAIR-MR (unpaid) for Abbott; has served on advisory boards for Abbott and egnite; has received royalties from Edwards Lifesciences; and has received speaker fees from Medtronic, Edwards Lifesciences, and Atricure. Dr Ailawadi has received consulting fees from Abbott, Edwards Lifesciences, and Medtronic. Dr Whisenant has received consulting fees from Abbott and Edwards Lifesciences. Dr Makkar has received grants and institutional research support from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; has received consulting fees from Cordis Corporation and Medtronic; and has performed unpaid trial activities for Abbott, Boston Scientific, and Edwards Lifesciences. Dr Tadros has received consulting fees from Abbott and Edwards Lifesciences. Dr Naik has received consulting fees from Abbott, Boston Scientific, and Edwards Lifesciences. Dr Fam has received consulting fees from Abbott. Dr Sauer has received grants and institutional research support from Saint Luke’s Mid America Heart Institute, Bayer, CSL Vifor, Pfizer, Rivus, AstraZeneca, Novo Nordisk, Impulse Dynamics, 35Pharma, Abbott, Boston Scientific, General Prognostics, Acorai, Story Health, and Amgen; and has received honoraria for speaking or advising from Bayer, CSL Vifor, Abbott, Impulse Dynamics, Boston Scientific, Edwards Lifesciences, Acorai, Story Health, and General Prognostics. Dr Kar has received consulting fees from Abbott, Boston Scientific, InterShunt, Medtronic, Peija, V-Wave, W.L. Gore, and Medtronic; and has served as co-principal investigator of the EXPAND and REPAIR MR trials for Abbott. Dr von Bardeleben has performed unpaid trial activities for Abbott, Edwards Lifesciences, and University of Göttingen (IIT); and has served on advisory boards or speakers bureaus for Abbott, Bioventrix, Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, and NeoChord. Dr Hahn has received speaker fees from Abbott, Baylis Medical Company Inc, Edwards Lifesciences, Medtronic, and Philips. Dr Hamid has received consulting fees from 4C Medical Technologies, Inc, Alleviant Medical, Inc, AMX, Anteris Technologies Corporation, Edwards Lifesciences, Philips, Valcare Med Ltd, VDyne, and W.L. Gore & Associates, Inc. Dr Zbinden has been a senior clinical scientist for Abbott. Dr Sorajja is co-principal investigator for the TRILUMINATE Pivotal trial; has served on advisory boards for Anteris Technologies and VDyne; and has received consulting fees from Boston Scientific, Edwards Lifesciences, Evolution Medical, Medtronic, Shifamed, TriFlo, and W.L. Gore & Associates, Inc. Dr Adams is co-principal investigator for the TRILUMINATE Pivotal trial; and receives royalties from Edward Lifesciences and Medtronic. Dr Murthy has reported that she has no relationships relevant to the contents of this paper to disclose., (Copyright © 2024. Published by Elsevier Inc.)- Published
- 2024
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31. Should Routine CT Follow-Up Be Considered After TAVR?
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Fukui M and Sorajja P
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Competing Interests: Dr Fukui has served as a consultant for Edwards Lifesciences. Dr Sorajja has served as consultant for 4C Medical, Abbott Structural, Adona Shifamed, Boston Scientific, Foldax, GE Medical, Haemonetics, Laza, Medtronic, Philipps, xDot, and VDyne.
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- 2024
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32. A Bright Future for Tricuspid Repair Success.
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Sorajja P and Hamid N
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- Humans, Cardiac Surgical Procedures methods, Cardiac Surgical Procedures trends, Tricuspid Valve Insufficiency surgery, Tricuspid Valve surgery, Tricuspid Valve diagnostic imaging
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Competing Interests: Funding Support and Author Disclosures Dr Sorajja has received consulting fees from 4C Medical, Abbott Structural, Adona, Boston Scientific, Edwards Lifesciences, Evolution Medical, Laza, Medtronic, Philips, vDyne, and xDot. Dr Hamid has received consulting fees from 4C Medical, Abbott Structural, Anteris, Edwards Lifesciences, Alleviant Medical, vDyne, WL Gore, and Laza.
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- 2024
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33. In Vivo Computed Tomography Sizing for Redo-Transcatheter Aortic Valve Replacement in Evolut Valves: Impact on Sizing, Feasibility, and Prosthesis-Patient Mismatch.
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Okada A, Fukui M, Zaid S, Thao KR, Walser-Kuntz E, Stanberry LI, Burns MR, Koike H, Wang C, Phichaphop A, Lesser JR, Cavalcante JL, Sorajja P, and Bapat VN
- Subjects
- Humans, Male, Female, Aged, Treatment Outcome, Aged, 80 and over, Risk Factors, Retrospective Studies, Reoperation, Tomography, X-Ray Computed, Heart Valve Prosthesis, Aortic Valve surgery, Aortic Valve diagnostic imaging, Aortic Valve physiopathology, Feasibility Studies, Transcatheter Aortic Valve Replacement instrumentation, Transcatheter Aortic Valve Replacement adverse effects, Prosthesis Design, Aortic Valve Stenosis surgery, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis physiopathology, Predictive Value of Tests
- Abstract
Background: SAPIEN3 (S3) is a ubiquitous redo-transcatheter aortic valve (TAV) replacement alternative for degenerated Evolut valves, but S3 sizing for S3-in-Evolut remains unclear. We sought to compare the impact of in vivo computed tomography (CT)-sizing on redo-TAV feasibility for S3-in-Evolut with traditional bench-sizing., Methods: CT scans of 290 patients treated using Evolut R/PRO/PRO+ between July 2015 and December 2021 were analyzed. S3-in-Evolut was simulated using S3 outflow/neoskirt plane (NSP) at node-6, -5, and -4. CT-sizing for S3 was determined by averaging 4 areas of the Evolut stent frame at NSP level and 3 nodes below. Redo-TAV was deemed feasible if the NSP was below the coronaries, or the narrowest valve (virtual S3)-to-aorta distance was >4 mm. Risk of prosthesis-patient mismatch was estimated using predicted indexed-effective orifice area., Results: Compared with bench-sizing, CT-sizing yielded smaller S3 size in 82% at node-6, 81% at node-5, and 84% at node-4. Factors associated with CT-sizing less than bench-sizing were larger index Evolut size, underexpansion of index Evolut, and shallower implant depth (all P <0.05). CT-sizing increased redo-TAV feasibility by +8% at node-6, +10% at node-5, and +4% at node-4. Redo-TAV feasibility increased with annulus size, sinotubular junction dimensions, coronary heights, index Evolut size, deeper Evolut implant depth, and lower NSP levels (all P <0.05). CT-sizing had a slightly higher estimated risk of severe prosthesis-patient mismatch (9% at node-6, 7% at node-5, and 6% at node-4), which could be mitigated by changing the NSP., Conclusions: CT-sizing for S3-in-Evolut is associated with higher feasibility of redo-TAV compared with bench-sizing, potentially reducing the risk of excessive oversizing and S3 underexpansion. Further validation using real-world clinical data is necessary., Competing Interests: Dr Bapat has received consulting fees from Abbott Structural, Medtronic, Boston Scientific, Edwards Lifesciences. Dr Cavalcante has received consulting fees from 4C, Abbott Structural, Anteris, AriaCV, Boston Scientific, Edwards Lifesciences, HighLife, Medtronic, VDyne, WL Gore, Xylocor; has received research grant support from Abbott Northwestern Hospital Foundation; Dr Sorajja has received consulting fees from 4C Medical, Abbott Structural, Adona, Boston Scientific, Edwards Lifesciences, Evolution Medical, Foldax, GE Medical, Laza, Medtronic, Phillips, WL Gore, vDyne, xDot; has received institutional research grant support from Abbott Structural, Edwards Lifesciences, Medtronic and Boston Scientific. The other authors report no conflicts.
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- 2024
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34. Clinical outcomes and predictors of transapical transcatheter mitral valve replacement: the Tendyne Expanded Clinical Study.
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Conradi L, Ludwig S, Sorajja P, Duncan A, Bethea B, Dahle G, Babaliaros V, Guerrero M, Thourani V, Dumonteil N, Modine T, Garatti A, Denti P, Leipsic J, Chuang ML, Blanke P, Muller DW, and Badhwar V
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- Humans, Male, Female, Aged, Treatment Outcome, Aged, 80 and over, Heart Valve Prosthesis, Risk Factors, Middle Aged, Mitral Valve Insufficiency surgery, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency physiopathology, Mitral Valve Insufficiency mortality, Heart Valve Prosthesis Implantation methods, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation instrumentation, Mitral Valve surgery, Mitral Valve diagnostic imaging, Mitral Valve physiopathology, Cardiac Catheterization methods, Cardiac Catheterization adverse effects, Cardiac Catheterization instrumentation
- Abstract
Background: Transcatheter mitral valve replacement (TMVR) is a therapeutic option for patients with severe mitral regurgitation (MR) who are ineligible for conventional surgery. There are limited data on the outcomes of large patient cohorts treated with TMVR., Aims: This study aimed to investigate the outcomes and predictors of mortality for patients treated with transapical TMVR., Methods: This analysis represents the clinical experience of all patients enrolled in the Tendyne Expanded Clinical Study. Patients with symptomatic MR underwent transapical TMVR with the Tendyne system between November 2014 and June 2020. Outcomes and adverse events up to 2 years, as well as predictors of short-term mortality, were assessed., Results: A total of 191 patients were treated (74.1±8.0 years, 62.8% male, Society of Thoracic Surgeons Predicted Risk of Mortality 7.7±6.6%). Technical success was achieved in 96.9% (185/191), and there were no intraprocedural deaths. At 30-day, 1- and 2-year follow-up, the rates of all-cause mortality were 7.9%, 30.8% and 40.5%, respectively. Complete MR elimination (MR <1+) was observed in 99.3%, 99.1% and 96.3% of patients, respectively. TMVR treatment resulted in consistent improvement of New York Heart Association Functional Class and quality of life up to 2 years (both p<0.001). Independent predictors of early mortality were age (odds ratio [OR] 1.11; p=0.003), pulmonary hypertension (OR 3.83; p=0.007), and institutional experience (OR 0.40; p=0.047)., Conclusions: This study investigated clinical outcomes in the full cohort of patients included in the Tendyne Expanded Clinical Study. The Tendyne TMVR system successfully eliminated MR with no intraprocedural deaths, resulting in an improvement in symptoms and quality of life. Continued refinement of clinical and echocardiographic risks will be important to optimise longitudinal outcomes.
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- 2024
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35. Changing Context and Goals for Transcatheter Mitral Therapy.
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Sorajja P
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- Humans, Treatment Outcome, Heart Valve Prosthesis, Risk Factors, Clinical Decision-Making, Recovery of Function, Hemodynamics, Cardiac Catheterization instrumentation, Cardiac Catheterization adverse effects, Mitral Valve diagnostic imaging, Mitral Valve surgery, Mitral Valve physiopathology, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation adverse effects, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency physiopathology, Mitral Valve Insufficiency surgery, Mitral Valve Insufficiency therapy
- Abstract
Competing Interests: Funding Support and Author Disclosures Dr Sorajja has received consulting fees from 4C Medical, Abbott Structural, Adona, Boston Scientific, Edwards Lifesciences, Evolution Medical, Laza, Medtronic, Philips, vDyne, and xDot.
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- 2024
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36. 3-Year Outcome of Tendyne Transcatheter Mitral Valve Replacement to Treat Severe Symptomatic Mitral Valve Regurgitation.
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Duncan A, Sorajja P, Dahle G, Denti P, Badhwar V, Conradi L, Babaliaros V, and Muller D
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- Humans, Treatment Outcome, Time Factors, Male, Female, Aged, Hemodynamics, Aged, 80 and over, Mitral Valve Insufficiency physiopathology, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency surgery, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation adverse effects, Cardiac Catheterization instrumentation, Cardiac Catheterization adverse effects, Mitral Valve surgery, Mitral Valve physiopathology, Mitral Valve diagnostic imaging, Heart Valve Prosthesis, Severity of Illness Index, Prosthesis Design, Recovery of Function
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- 2024
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37. Preprocedural Computed Tomography Planning for Surgical Aortic Valve Replacement.
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Okada, Atsushi, Beckmann, Erik, Rocher, Erick E., Fukui, Miho, Wang, Cheng, Phichaphop, Asa, Koike, Hideki, Thao, Kiahltone R., Willett, Andrew, Walser-Kuntz, Evan, Stanberry, Larissa I., Enriquez-Sarano, Maurice, Lesser, John R., Sun, Benjamin, Steffen, Robert J., Sorajja, Paul, Cavalcante, João L., and Bapat, Vinayak N.
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Selection of transcatheter valve size using preprocedural computed tomography (CT) is standardized and well established. However, valve sizing for surgical aortic valve replacement (SAVR) is currently performed intraoperatively by using sizers, which may result in variation among operators and risk for prosthesis-patient mismatch. This study evaluated the usefulness of CT annulus measurement for SAVR valve sizing. This study included patients who underwent SAVR using Inspiris or Magna Ease and received preoperative electrocardiogram-gated CT imaging. Starting from June 2022, study investigators applied a CT sizing algorithm using CT-derived annulus size to guide minimum SAVR label size. The final decision of valve selection was left to the operating surgeon during SAVR. The study compared the appropriateness of valve selection (comparing implanted size with CT-predicted size) and prosthesis-patient mismatch rates without aortic root enlargement between 2 cohorts: 102 cases since June 2022 (CT sizing cohort) and 180 cases from 2020 to 2021 (conventional sizing cohort). Implanted size smaller than CT predicted size and severe prosthesis-patient mismatch were significantly lower by CT sizing than by conventional sizing (12% vs 31% [ P =.001] and 0% vs 6% [ P =.039], respectively). Interoperator variability was a factor associated with implanted size smaller than CT predicted with conventional sizing, whereas it became nonsignificant with CT sizing. Applying CT sizing to SAVR led to improved valve size selection, less prosthesis-patient mismatch, and less interoperator variability. CT sizing for SAVR could also be used to predict prosthesis-patient mismatch before SAVR and identify patients who need aortic root enlargement. [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2024
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38. 3D Navigation and Intraprocedural Intracardiac Echocardiography Imaging for Tricuspid Transcatheter Edge-to-Edge Repair.
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Hamid, Nadira, Aman, Edris, Bae, Richard, Scherer, Markus, Smith, Thomas W.R., Schwartz, Jonathan, Rinaldi, Michael, Singh, Gagan, and Sorajja, Paul
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- 2024
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39. Comprehensive Myocardial Assessment by Computed Tomography: Impact on Short-Term Outcomes After Transcatheter Aortic Valve Replacement.
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Koike, Hideki, Fukui, Miho, Treibel, Thomas, Stanberry, Larissa I., Cheng, Victor Y., Enriquez-Sarano, Maurice, Schmidt, Stephanie, Schelbert, Erik B., Wang, Cheng, Okada, Atsushi, Phichaphop, Asa, Sorajja, Paul, Bapat, Vinayak N., Leipsic, Jonathon, Lesser, John R., and Cavalcante, João L.
- Abstract
Quantification of myocardial changes in severe aortic stenosis (AS) is prognostically important. The potential for comprehensive myocardial assessment pre–transcatheter aortic valve replacement (TAVR) by computed tomography angiography (CTA) is unknown. This study sought to evaluate whether quantification of left ventricular (LV) extracellular volume—a marker of myocardial fibrosis—and global longitudinal strain—a marker of myocardial deformation—at baseline CTA associate with post-TAVR outcomes. Consecutive patients with symptomatic severe AS between January 2021 and June 2022 who underwent pre-TAVR CTA were included. Computed tomography extracellular volume (CT-ECV) was derived from septum tracing after generating the 3-dimensional CT-ECV map. Computed tomography global longitudinal strain (CT-GLS) used semi-automated feature tracking analysis. The clinical endpoint was the composite outcome of all-cause mortality and heart failure hospitalization. Among the 300 patients (80.0 ± 9.4 years of age, 45% female, median Society of Thoracic Surgeons Predicted Risk of Mortality score 2.80%), the left ventricular ejection fraction (LVEF) was 58% ± 12%, the median CT-ECV was 28.5% (IQR: 26.2%-32.1%), and the median CT-GLS was −20.1% (IQR: −23.8% to −16.3%). Over a median follow-up of 16 months (IQR: 12-22 months), 38 deaths and 70 composite outcomes occurred. Multivariable Cox proportional hazards model, accounting for clinical and echocardiographic variables, demonstrated that CT-ECV (HR: 1.09 [95% CI: 1.02-1.16]; P = 0.008) and CT-GLS (HR: 1.07 [95% CI: 1.01-1.13]; P = 0.017) associated with the composite outcome. In combination, elevated CT-ECV and CT-GLS (above median for each) showed a stronger association with the outcome (HR: 7.14 [95% CI: 2.63-19.36]; P < 0.001). Comprehensive myocardial quantification of CT-ECV and CT-GLS associated with post-TAVR outcomes in a contemporary low-risk cohort with mostly preserved LVEF. Whether these imaging biomarkers can be potentially used for the decision making including timing of AS intervention and post-TAVR follow-up will require integration into future clinical trials. [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2024
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40. Coronary revascularization and use of hemodynamic support in acute coronary syndromes
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Iosif Xenogiannis, Peter Tajti, M. Nicholas Burke, Ivan Chavez, Mario Gössl, Michael Mooney, Anil Poulose, Paul Sorajja, Jay Traverse, Yale Wang, and Emmanouil S. Brilakis
- Subjects
Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Cardiogenic shock develops in up to 10% of patients with acute myocardial infarction and continues to have high mortality. Early invasive treatment is the default therapeutic approach in these patients. On the basis of the results of the CULPRIT-SHOCK trial, culprit-only revascularization during the acute phase is preferred over multivessel revascularization. Routine use of intra-aortic balloon pump (IABP) is not recommended; however, the use of mechanical circulatory support has been increasing despite limited observational data to support its use. Several studies support multivessel revascularization in patients with uncomplicated ST-segment elevation acute myocardial infarction and simple nonculprit lesions to improve subsequent clinical outcomes. Keywords: Multivessel coronary artery disease, Cardiogenic shock, Acute coronary syndromes, STEMI, Non-STEMI
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- 2019
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41. MitraClip After Failed Surgical Mitral Valve Repair—An International Multicenter Study
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Zouhair Rahhab, David Scott Lim, Stephen H. Little, Maurizio Taramasso, Shingo Kuwata, Matteo Saccocci, Corrado Tamburino, Carmelo Grasso, Christian Frerker, Theresa Wißt, Ross Garberich, Jörg Hausleiter, Daniel Braun, Eleonora Avenatti, Victoria Delgado, Gian Paolo Ussia, Fausto Castriota, Roberto Nerla, Hüseyin Ince, Alper Öner, Rodrigo Estevez‐Loureiro, Azeem Latib, Damiano Regazzoli, Nicolo Piazza, Hind Alosaimi, Peter P. T. de Jaegere, Jeroen Bax, Danny Dvir, Francesco Maisano, Paul Sorajja, Michael J. Reardon, and Nicolas M. Van Mieghem
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MitraClip ,recurrent mitral regurgitation ,surgical mitral valve repair ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Background Recurrence of mitral regurgitation (MR) after surgical mitral valve repair (SMVR) varies and may require reoperation. Redo mitral valve surgery can be technically challenging and is associated with increased risk of mortality and morbidity. We aimed to assess the feasibility and safety of MitraClip as a treatment strategy after failed SMVR and identify procedure modifications to overcome technical challenges. Methods and Results This international multicenter observational retrospective study collected information for all patients from 16 high‐volume hospitals who were treated with MitraClip after failed SMVR from October 29, 2009, until August 1, 2017. Data were anonymously collected. Technical and device success were recorded per modified Mitral Valve Academic Research Consortium criteria. Overall, 104 consecutive patients were included. Median Society of Thoracic Surgeons score was 4.5% and median age was 73 years. At baseline, the majority of patients (82%) were in New York Heart Association class ≥III and MR was moderate or higher in 86% of patients. The cause of MR pre‐SMVR was degenerative in 50%, functional in 35%, mixed in 8%, and missing/unknown in 8% of patients. The median time between SMVR and MitraClip was 5.3 (1.9–9.7) years. Technical and device success were 90% and 89%, respectively. Additional/modified imaging was applied in 21% of cases. An MR reduction of ≥1 grade was achieved in 94% of patients and residual MR was moderate or less in 90% of patients. In‐hospital all‐cause mortality was 2%, and 86% of patients were in New York Heart Association class ≤II. Conclusions MitraClip is a safe and less invasive treatment option for patients with recurrent MR after failed SMVR. Additional/modified imaging may help overcome technical challenges during leaflet grasping.
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- 2021
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42. Coronavirus Disease 2019 Catheterization Laboratory Survey
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Subhash Banerjee, Giuseppe Tarantini, Mazen Abu‐Fadel, Avantika Banerjee, Bertis B. Little, Paul Sorajja, Mehdi H. Shishehbor, and Emmanouil S. Brilakis
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coronavirus disease 2019 ,COVID‐19 ,catheterization laboratory ,survey ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Background The coronavirus disease 2019 pandemic is expected to affect operations and lifestyles of interventional cardiologists around the world in unprecedented ways. Timely gathering of information on this topic can provide valuable insight and improve the handling of the ongoing and future pandemic outbreaks. Methods and Results A survey instrument developed by the authors was disseminated via e‐mail, text messaging, WhatsApp, and social media to interventional cardiologists between April 6, 2020, and April 11, 2020. A total of 509 responses were collected from 18 countries, mainly from the United States (51%) and Italy (36%). Operators reported significant decline in coronary, structural heart, and endovascular procedure volumes. Personal protective equipment was available to 95% of respondents; however FIT‐tested N95 or equivalent masks were available to only 70%, and 74% indicated absence of coronavirus disease 2019 pretesting. Most (83%) operators expressed concern when asked to perform cardiac catheterization on a suspected or confirmed coronavirus disease 2019 patient, primarily because of fear of viral transmission (88%). Although the survey demonstrated significant compliance with social distancing, high use of telemedicine (69%), and online education platforms (80%), there was concern over impending financial loss. Conclusions Our survey indicates significant reduction in invasive procedure volumes and concern for viral transmission. There is near universal adoption of personal protective equipment; however, coronavirus disease 2019 pretesting and access to FIT‐tested N95 masks is suboptimal. Although there is concern over impending financial loss, substantial engagement in telemedicine and online education is reported.
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- 2020
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43. Guidance on Short‐Term Management of Atrial Fibrillation in Coronavirus Disease 2019
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Pattara Rattanawong, Win Shen, Hicham El Masry, Dan Sorajja, Komandoor Srivathsan, Arturo Valverde, and Luis R. Scott
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antiarrhythmic drug ,atrial fibrillation ,COVID‐19 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Abstract Atrial fibrillation is a common clinical manifestation in hospitalized patients with coronavirus disease 2019 (COVID‐19). Medications used to treat atrial fibrillation, such as antiarrhythmic drugs and anticoagulants, may have significant drug interactions with emerging COVID‐19 treatments. Common unintended nontherapeutic target effects of COVID‐19 treatment include potassium channel blockade, cytochrome P 450 isoenzyme inhibition or activation, and P‐glycoprotein inhibition. Drug‐drug interactions with antiarrhythmic drugs and anticoagulants in these patients may lead to significant bradycardia, ventricular arrhythmias, or severe bleeding. It is important for clinicians to be aware of these interactions, drug metabolism changes, and clinical consequences when choosing antiarrhythmic drugs and anticoagulants for COVID‐19 patients with atrial fibrillation. The objective of this review is to provide a practical guide for clinicians who are managing COVID‐19 patients with concomitant atrial fibrillation.
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- 2020
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44. Invasive versus non-invasive assessment of valvuloarterial impedance in severe aortic stenosis
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Lisa Stanberry, Aisha Ahmed, Paul Sorajja, Joao L Cavalcante, and Mario Gossl
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Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Background As a measure of the global left ventricular afterload, valvuloarterial impedance (ZVA) can be estimated using transthoracic echocardiography (TTE) and invasive measuring methods. The objective of this study was to compare the performance of TTE in measuring ZVA with invasive haemodynamics, direct Fick and thermodilution (TD), in patients with severe aortic stenosis (AS).Methods This is a retrospective cohort study of 66 patients with severe AS who underwent TTE and bilateral heart catheterisation preaortic valve replacement. ZVA was calculated non-invasively from TTE and invasively using TD and Fick. The differences in measurements were estimated using a generalised estimating equation approach. The exchangeability of the measurements from different methods was evaluated under binary risk stratification rules.Results The mean±SD ZVA by TTE was 4.6±1.4 vs 4.9±1.6 by TD vs 4.3±1.2 mm Hg m2/mL by Fick. From multivariate analyses, ZVA by TTE was 5.9% (95% CI −15.0 to 2.5) lower than by TD and 5.9% (95% CI −1.5 to 12.8) higher than by Fick. At the same time, ZVA by TD was 12.5% (3.0 to 22.9) higher than with Fick. Risk classifications for ZVA-based binary decision rules showed poor agreement between TTE and invasive methods (kappa ≤0.3).Conclusions The differences in ZVA estimates between TTE and invasive standards do not appear to exceed those between the standards. As such TTE-based estimates may be deemed acceptable as a clinical measure of global haemodynamic load. However, TTE-based and invasive measurements may not be interchangeable to identify patients at risk using binary classification rules based on ZVA.
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- 2020
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45. Impact of the Commercial Introduction of Transcatheter Mitral Valve Repair on Mitral Surgical Practice
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Hiroki Niikura, Mario Gössl, Richard Bae, Benjamin Sun, Judah Askew, Kevin Harris, Karol Mudy, Craig Strauss, Larissa Stanberry, Andrea Sweeney, and Paul Sorajja
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halo effect ,MitraClip ,mitral regurgitation ,mitral surgery ,transcatheter mitral valve repair ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Background There has been uncertainty regarding the effect of transcatheter mitral valve repair (TMVr) with MitraClip on cardiac surgical practice. Our aim was to examine the impact of the commercial introduction of TMVr to a comprehensive mitral program. Methods and Results We evaluated 875 patients (aged 69±14 years; 58% men) who underwent transcatheter or mitral surgical procedures over a 6‐year period at our institution. Main outcomes were changes in surgical procedural volume after TMVr introduction and short‐term mortality for surgical and TMVr procedures. The numbers of patients treated with MitraClip, isolated mitral repair, and any mitral surgery were 249, 292, and 626 patients, respectively. Compared with surgery, patients with MitraClip were older (aged 82±8 versus 64±12 years; P
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- 2020
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46. Diverse perspectives and training paths in cardiology: An analysis of authorship in the Journal of the American College of Cardiology
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Barbara A. Danek, Aris Karatasakis, Judit Karacsonyi, Bavana V. Rangan, Shuaib Abdullah, Paul Sorajja, Subhash Banerjee, and Emmanouil S. Brilakis
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Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Background: The role of women and foreign medical graduates (FMGs) in cardiology research published in the United States has received limited study. Methods: We examined the characteristics of the first and last authors of all original contributions and review articles published in the Journal of the American College of Cardiology from October 1, 2015, to October 1, 2016. Results: A total of 345 articles were identified, with 687 first and last authors originating from ≥50 different countries. Overall, 17% of authors were women (20% of the first and 14% of the last authors). Overall, 86% of authors held a medical degree (MD) or equivalent, and 25% of those also held another advanced degree (PhD, MPH, and/or MBA). The proportion of authors with an advanced degree in addition to an MD/equivalent was higher among foreign graduates and international contributors as compared with American graduates (31% vs. 30% vs. 17%, respectively, p
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- 2019
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47. Intermodality Comparison Of Myocardial Extracellular Volume Fraction Assessment In Patients Undergoing TAVR Or TMVR Evaluation
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Lesser, A., primary, Koike, H., additional, Schmidt, S., additional, Cheng, V., additional, Fukui, M., additional, Okada, A., additional, Wang, C., additional, Phichaphop, A., additional, Bapat, V., additional, Sorajja, P., additional, Enriquez-Sarano, M., additional, Lesser, J., additional, and Cavalcante, J., additional
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- 2023
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48. DurAVR TAVI First-in-Human Study Confirms Excellent Haemodynamics to One Year
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Poon, K., primary, Meduri, C., additional, Kodali, S., additional, Sorajja, P., additional, Feldt, K., additional, Garg, P., additional, Cavalcante, J., additional, Hamid, N., additional, Sathananthan, J., additional, Bapat, V., additional, and Sinhal, A., additional
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- 2023
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49. Deformation Of Transcatheter Heart Valve After Mitral Valve-in-valve Associates With Hypoattenuating Leaflet Thickening
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Fukui, M., primary, Cavalcante, J., additional, Okada, A., additional, Burns, M., additional, Koike, H., additional, Enriquez-Sarano, M., additional, Lesser, J., additional, Sorajja, P., additional, and Bapat, V., additional
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- 2023
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50. Impact Of Comprehensive Computed Tomography Assessment With Extracellular Volume And Longitudinal Strain Analysis On Transcatheter Aortic Valve Replacement Outcomes
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Koike, H., primary, Schmidt, S., additional, Cheng, V., additional, Fukui, M., additional, Okada, A., additional, Wang, C., additional, Phichaphop, A., additional, Bapat, V., additional, Sorajja, P., additional, Enriquez-Sarano, M., additional, Lesser, J., additional, and Cavalcante, J., additional
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- 2023
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