657 results on '"Kirklin, JK"'
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2. Merging of the Pediatric Interagency Registry for Mechanically Assisted Circulatory Support (PediMACS) with an Exyernal Administrative Database Using Indirect Patient Identifiers to Develop a More Comprehensive Platform for Health Economics and Outcomes Research
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Dai, D, primary, Huang, YH, additional, Shamszad, P, additional, Rossano, JW, additional, Cantor, RS, additional, Hall, M, additional, and Kirklin, JK, additional
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- 2018
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3. PRM39 - Merging of the Pediatric Interagency Registry for Mechanically Assisted Circulatory Support (PediMACS) with an Exyernal Administrative Database Using Indirect Patient Identifiers to Develop a More Comprehensive Platform for Health Economics and Outcomes Research
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Dai, D, Huang, YH, Shamszad, P, Rossano, JW, Cantor, RS, Hall, M, and Kirklin, JK
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- 2018
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4. Second Intermacs Annual Report: More Than 1000 Primary LVAD Implants
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Kirklin, JK, Naftel, DC, Kormos, RL, Stevenson, LW, Pagani, FD, Miller, MA, Ulisney, KL, Baldwin, JT, and Young, JB
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Article - Published
- 2010
5. Is the 'Perfect Fontan' operation routinely achievable in the modern era?
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Kirklin JK, Brown RN, Bryant AS, Naftel DC, Colvin EV, Bennett Pearce F, Romp RL, Johnson WH, Lau YR, McMahon WS, Knott-Craig CJ, and Pacifico AD
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- 2008
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6. Ventricular assist devices as a bridge to heart transplantation in children.
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Bastardi HJ, Naftel DC, Webber SA, Dillis S, Kirklin JK, and Blume ED
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The increase in time waiting for appropriate pediatric allografts for heart transplantation has mandated the use of long-term mechanical assistance in the pediatric population. Extracorporeal membrane oxygenation support has been routinely used but is limited by both its inability to provide support without life-threatening complications for longer than 2 to 3 weeks as well as the inability of patients to achieve mobility. For the past 10 years, pediatric programs have increasing experience with the use of ventricular assist devices (VADs) to bridge patients to heart transplant. This retrospective study analyzed the clinical features and outcomes of 99 pediatric patients who underwent VAD implant as a bridge to heart transplant. METHODS: Between 1993 and 2003, the Pediatric Heart Transplant Study Group enrolled 2,375 patients (age 1 day-17.9 years) listed for heart transplant from 23 participating centers. Four percent (99 patients) of those listed received VAD support as a bridge to transplantation. Seventy-seven (77%) patients survived to transplant with a mean time on support of 57 days. There were 17 deaths on support and 5 bridged to recovery. Overall incidence of adverse events was similar to the adult data with a 19% risk of stroke. There was no difference in 5-year survival after transplant for patients on VAD at time of transplant compared with those (n = 2,293) not requiring VAD (77% vs 73%, P = .8). These data suggest that despite the lack of pediatric specific devices and relatively high adverse event rate, VADs may be used as a bridge to transplant therapy in appropriate-sized children with the expectation of a successful outcome in most patients. [ABSTRACT FROM AUTHOR]
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- 2008
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7. Outcome of listing for cardiac transplantation for failed Fontan: a multi-institutional study.
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Bernstein D, Naftel D, Chin C, Addonizio LJ, Gamberg P, Blume ED, Hsu D, Canter CE, Kirklin JK, Morrow WR, and Pediatric Heart Transplant Study
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- 2006
8. Outcomes of children bridged to heart transplantation with ventricular assist devices: a multi-institutional study.
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Blume ED, Naftel DC, Bastardi HJ, Duncan BW, Kirklin JK, Webber SA, and Pediatric Heart Transplant Study Investigators
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- 2006
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9. Mechanical circulatory support therapy as a bridge to transplant or recovery (new advances)
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Kirklin JK and Holman WL
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- 2006
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10. Transesophageal echocardiographic diagnosis of aortic arch-left innominate vein fistula.
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Vengala S, Nanda NC, Sidhu MS, Dod HS, Agrawal G, Singh V, and Kirklin JK
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We present a patient with aortic arch-left innominate vein (LIV) fistula diagnosed by transesophageal echocardiography. Also, an interrupted linear echo was noted within the dilated LIV with flow signals moving across the area of interruption, suggestive of left innominate vein pseudo-aneurysm or dissection. The patient subsequently underwent successful surgical repair of the fistula.(ECHOCARDIOGRAPHY, Volume 22, January 2005) [ABSTRACT FROM AUTHOR]
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- 2005
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11. Primary angiosarcoma of the heart: CT characteristics
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Shin, MS, primary, Kirklin, JK, additional, Cain, JB, additional, and Ho, KJ, additional
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- 1987
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12. Images in clinical medicine. Mapping the atrioventricular node.
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Epstein AE, Kirklin JK, Epstein, Andrew E, and Kirklin, James K
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- 2007
13. Lymphoproliferative disorders after paediatric heart transplantation: a multi-institutional study.
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Webber SA, Naftel DC, Fricker FJ, Olesnevich P, Blume ED, Addonizio L, Kirklin JK, Canter CE, and Pediatric Heart Transplant Study
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- 2006
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14. Prevalence and Impact of Recurrent Rejection on Pediatric Heart Transplant Recipients: A PHTS Multi-Institutional Analysis.
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Amdani S, Kirklin JK, Cantor R, Koehl D, Lal A, Chau P, Curren V, Edelson JB, Parent JJ, Victor H, Burnette A, and Lamour JM
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- Humans, Male, Child, Female, Prevalence, Child, Preschool, Adolescent, Retrospective Studies, Infant, United States epidemiology, Heart Transplantation adverse effects, Graft Rejection epidemiology, Graft Rejection immunology, Recurrence
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Background: Studies evaluating the prevalence and impact of recurrent rejection (RR) in pediatric heart transplant (HT) are sparse., Objectives: The purpose of this study was to describe prevalence and impact of RR on cardiac allograft vasculopathy (CAV) and graft loss after pediatric HT., Methods: Data on HT from January 1, 2000, to June 30, 2020, in the Pediatric Heart Transplant Society database were included. Freedom from RR (≥2 rejection episodes) was compared by era (early: 2000-2009; current: 2010-2020). Outcomes for children experiencing RR were compared with those experiencing 0 or 1 rejection episodes and by type of RR (antibody-mediated rejection [AMR], acute cellular rejection [ACR], mixed [ACR/AMR])., Results: Of 6,342 HT recipients, 1,035 (17%) experienced RR. In the current era, pediatric HT recipients were less likely to experience RR (P < 0.001). Freedom from CAV was similar for those experiencing RR to those experiencing 0 or 1 episode (96.6% vs 95.3% vs 96.6%); and similar regardless of the type of RR (AMR, ACR, or mixed) (65.5% vs 82.9% vs 100%) (P > 0.05). Freedom from graft loss was significantly lower for those experiencing RR to those experiencing 0 or 1 episode (56.3% vs 72.3% vs 82.3%) and lower for those experiencing recurrent mixed rejection or recurrent AMR compared with those experiencing recurrent ACR (65.3% vs 50% vs 81.8%). Black children experiencing RR subsequently had lower freedom from CAV and graft loss than White children (P < 0.05 for all)., Conclusions: Although prevalence of RR has decreased, children experiencing RR are at greatly increased risk for losing their graft, particularly those who have recurrent mixed or antibody-mediated rejection., Competing Interests: Funding Support and Author Disclosures Dr Amdani is the site principal investigator for a multicenter study led by the University of Michigan and has received no salary support. Dr Kirklin has received royalties related to IT software development in registry database design developed at and licensed from the University of Alabama at Birmingham; has received payments from Kirklin Solutions Co database development and analytics and partial salary support in his role as Director of the data center for STS Intermacs/Pedimacs Registries; and serves as Chair of the Data and Safety Monitoring Board for Xeltis cardiac conduit clinical trial and Chair of the Data and Safety Monitoring Board for Carmat TAH clinical trial. Dr Lal is a site PI for the TEAMMATE trial, with grant funding from the United States Department of Defense (W81XWH-17-1-0532). Dr Edelson has received grant support from Enduring Hearts and the University of Pennsylvania McCabe Award; and has received honoraria from Abbott Technologies. 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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15. Early Outcomes for Management of Atrioventricular Septal Defect-Tetralogy of Fallot in the Last Decade: A Congenital Heart Surgeons' Society Study.
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Callahan CP, Argo MB, McCrindle BW, Barron DJ, Jegatheeswaran A, Honjo O, Polimenakos AC, Turek JW, Dabal RJ, Kirklin JK, DeCampli WM, Eghtesady P, and Overman DM
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Background: We sought to determine the management and early outcomes of complete atrioventricular septal defect-tetralogy of Fallot (AVSD-TOF) for a contemporary multicenter cohort., Methods: Of 739 participants in the Congenital Heart Surgeons' Society AVSD cohort (January 2012-May 2021), 40 had AVSD-TOF. We first compared survival differences for patients with AVSD-TOF versus those with isolated AVSD using propensity matching. Secondly, for patients with AVSD-TOF, we compared staged (n = 16) versus primary (n = 24) repair by assessing the following: patient characteristics, progression of atrioventricular valve (AVV) regurgitation, and time-related reoperation and survival., Results: Five-year survival was similar between matched AVSD-TOF and isolated AVSD groups (80% vs 81%, P = .9). Compared with primary repair patients, staged patients had smaller pulmonary valve annulus Z-score measured at first presentation (-2.2 vs -2.9, P = .006). All staged patients (12 Blalock-Thomas-Taussig shunts, 3 right-ventricular-outflow-tract stents, 1 ductal stent) survived to complete repair. Freedom from AVSD-related reoperation five years post-AVSD-TOF repair was 57% after staged versus 90% after primary repair ( P < .05) and left AVV reoperations were the most frequent reintervention. Survival five years after AVSD-TOF repair was 80% (63% after staged vs 90% after primary repair; P = .08)., Conclusions: Patients undergoing AVSD-TOF repair have similar survival compared with matched isolated AVSD patients. Although approximately half of AVSD-TOF patients had initial palliation and all survived to complete repair, staged repair patients had lower survival and a higher reintervention rate compared with primary repair patients. The decision to pursue staged versus primary repair for future babies with AVSD-TOF remains challenging and should be chosen based on individual circumstances., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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- 2024
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16. Management of Tricuspid Atresia With Normally Related Great Arteries and Left-Sided Obstruction.
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Palacio AM, Williams WG, Barron DJ, Argo MB, Jegatheeswaran A, Jacobs ML, Bondarenko I, Welke KF, Kirklin JK, Karamlou T, Alsoufi B, and McCrindle BW
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Background: Tricuspid atresia (TA) is the second most common form of functionally univentricular heart. For patients with TA and normally related great arteries (Type I), left ventricular outflow tract obstruction (LVOTO) is rare., Methods: From the Congenital Heart Surgeons' Society multi-institutional cohort of 445 patients with Type I TA enrolled from 1999 to 2024 from 42 sites, 14 infants (3%) had interventions for associated LVOTO, either at presentation or after their first TA-related intervention., Results: Of seven infants initially undergoing Norwood/Damus-Kaye-Stansel (DKS), six survived to Stage II, of whom five survived with one developing pulmonary hypertension and four achieving Fontan. An additional seven infants who were first managed with pulmonary artery band placement subsequently had bidirectional superior cavopulmonary anastomosis (BCPA) and a DKS procedure; there were six survivors, all achieving Fontan. All ten survivors who underwent the Fontan procedure had normal left ventricular and mitral valve function at the latest follow-up. The overall Kaplan-Meier survival estimate at 20 years for these 14 patients was 79% (70% CI, 66%-88%), and the median follow-up was 8.3 years (0.24-21.5)., Conclusions: While infants with TA and transposition of the great arteries are more likely to have LVOTO, this can also occur in the setting of normally related great arteries. Infants with Type I TA and LVOTO can be managed in the neonatal period with the Norwood procedure ensuring complete arch relief with acceptable outcomes. If LVOTO becomes evident after initial pulmonary artery band placement, a subsequent DKS procedure facilitates satisfactory success to Fontan., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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- 2024
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17. Invited Commentary: Establishment of a Global Platform for the Treatment of Congenital Heart Disease by "Creation and Unification of National Congenital Heart Surgery Databases and Registries": It's Time!
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St Louis JD, Jacobs JP, Bateson BP, Tchervenkov CI, Austin EH, and Kirklin JK
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Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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- 2024
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18. Defining optimal left ventricular assist device short-term outcomes may provide insight into programmatic quality assessment.
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Cowger JA, Molina E, Deng L, Kanwar M, Shah P, Cogswell R, Gosev I, Cantor RS, Dardas TF, Kirklin JK, Rogers JG, Cleveland JC, Sandau KE, McIlvennan CK, Kaczorowski D, Estep JD, and Pagani FD
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- Humans, Male, Female, Middle Aged, Retrospective Studies, Time Factors, Registries, Treatment Outcome, Quality Assurance, Health Care, Aged, Follow-Up Studies, Survival Rate trends, Postoperative Complications epidemiology, United States, Adult, Heart-Assist Devices, Heart Failure surgery, Heart Failure therapy, Heart Failure mortality, Quality of Life
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Background: Patients have substantial variability in perioperative outcomes after left ventricular assist device (LVAD) implant. A perioperative multidimensional tool integrating mortality, adverse events (AEs), and patient-reported outcomes to assist in quality improvement initiatives is needed., Methods: Patients undergoing HeartMate 3 LVAD implant (January 1, 2017 to January 31, 2024) in the Society of Thoracic Surgeons' Intermacs registry were studied. Cox proportional hazard multivariable analyses incorporating AEs as time-varying covariates for mortality out to 180 days was used to generate the INtermacs Short term composITE quality score (INSITE score derivation), reflecting the adjusted hazard ratio (HR) for mortality contributed by each AE, applying the global ranking methodology. In those alive and on support at 6 months, multivariable logistic regression (odds ratio) was used to examine the impact of AEs on health-related quality of life (QOL) at 180 days, captured through the INSITE-QOL score. Failure to achieve ≥1 point increase in visual analog scale from baseline was the event., Results: Of 13,148 patients, 4,389 (33.4%) suffered at least 1 AE or death through 180 days. Stroke (survival: HR 13.1; QOL: HR 1.7), dialysis (survival: HR 31.4; QOL: HR 4.2), prolonged respiratory failure (survival: HR 5.7; QOL: HR 2.3), reoperation (survival: HR 3.4; QOL: HR 1.6), and right heart failure (survival: 5.0; QOL: HR 1.4), contributed to both mortality and failure to improve QOL at 180 days (all p < 0.05). The median INSITE and INSITE-QOL scores were 0.0 [0.0, 1.6] and 0.0 [0.0, 0.0], respectively. At 9.4% (n = 17) of centers, a high INSITE score (≥13) was present in 15% of patients, while the top 25% of centers had perfect INSITE-QOL scores in at least 75% of patients., Conclusions: AEs after LVAD confer differential impact on mortality and QOL, enabling the development of global rank outcome scores. Given the high mortality hazard conferred by 180-day AEs, center-specific quality interventions aimed at reducing early complications provide the greatest opportunity to improve long-term survival and QOL., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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19. The Society of Thoracic Surgeons Intermacs 2024 Annual Report: Focus on Outcomes in Younger Patients.
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Meyer DM, Nayak A, Wood KL, Blumer V, Schettle S, Salerno C, Koehl D, Cantor R, Kirklin JK, Jacobs JP, Cascino T, Pagani FD, and Kanwar MK
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The 15th Annual Report from The Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support includes 29,634 continuous-flow left ventricular assist devices from the 10-year period between 2014 and 2024. The outcomes reported here demonstrate continued improved survival in the current era of fully magnetically levitated devices, with a significantly higher 1-year (85.7% vs 78.4%) and 5-year (59.7% vs 43.7%) survival than those receiving non-magnetically levitated devices. Magnetically levitated device recipients are experiencing a lower incidence of adverse events, including freedom from gastrointestinal bleeding (72.6%), device malfunction (82.9%), and stroke (86.7%) at 5 years. Additionally, a focus on a subgroup of patients younger than 50 years of age has demonstrated both superior outcomes in survival (91.6% survival at 1 year and 72.6% survival at 5 years) and decreased incidence of adverse events compared with older recipients. This younger cohort also demonstrated more tolerance to the characteristics of sex, race, ethnicity, and psychosocial indicators that are associated with worse outcomes after heart transplantation. Based upon these data, a potential net prolongation of life may be realized by considering prolonged left ventricular assist device support prior to heart transplantation in this population. These analyses provide preliminary data that could positively influence adoption of left ventricular assist device technology in groups previously not seen as candidates for this therapy, while providing a more responsible donor allocation strategy for advanced heart failure patients., Competing Interests: Disclosures Dan M. Meyer is on the clinical advisory board of PercAssist Corp. Aditi Nayak is on the clinical advisory board of PumpinHeart Limited, Ireland. Katherine L. Wood reports a relationship with Abbott that includes consulting or advisory. Sarah Schettle reports a relationship with the Medtronic Advisory Panel, and consulting with Abbott. James K. Kirklin discloses receiving partial salary support from the Society of Thoracic Surgeons (STS) as Director of the Data Center for STS Intermacs and being part owner and President of Kirklin Solutions, Inc., a University of Alabama at Birmingham (UAB) healthcare technology start-up company. Francis D. Pagani is a noncompensated ad-hoc scientific advisor for Abbott, Berlin Heals, FineHeart, and Medtronic, a non-compensated medical monitor for Abiomed, Scientific advisor for BrioHealth with travel compensation; and a member of the Data and Safety Monitoring Board (DSMB) for Carmat; and receives partial salary support from Blue Cross / Blue Shield of Michigan as Associate Director of the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative. Manreet K. Kanwar is on the Advisory Board for Abiomed, Abbott and CorWave, on CEC for BiVACOR, and a speaker for Abiomed. The other authors have no conflicts of interest to disclose., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)
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- 2024
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20. Heart transplantation for pediatric patients with malignant arrhythmias: Indications and Outcomes.
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Atallah J, Urschel S, Kirklin JK, Cantor R, Zhao H, Motiuk J, Hoffman TM, Weisert M, Lytrivi ID, Singh NM, Azeka E, and Wittlieb-Weber CA
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Background: Arrhythmias can lead to cardiac arrest and heart failure. When intractable, heart transplantation (HTX) can become the only viable treatment. This rare high-risk cohort has not been reported as a distinct group., Objective: The purpose of this study was to characterize the outcomes of pediatric patients listed for HTX with the primary indication being malignant arrhythmia (MA)., Methods: Using the Pediatric Heart Transplant Society prospective registry, we identified all patients younger than 18 years listed between 2014 and 2022. MA as the listing indication was categorized into primary tachyarrhythmia (PT), inherited arrhythmia (IA), congenital heart disease, and cardiomyopathy (CM) with secondary arrhythmia. Demographic, listing, and transplant data were analyzed., Results: Among 4630 patients listed and 3317 transplanted, MA was the indication in 63 (1.4%) and 49 (1.5%), respectively. Patients with MA were categorized as PT in 11 (17%), IA in 4 (6%), congenital heart disease in 6 (10%), and CM in 42 (67%). Compared with the non-MA cohort, patients listed for MA were older (mean age 10.6 ± 6.2 years vs 6.1 ± 6.2 years; P < .01), more likely to present with cardiac arrest (43% vs 11%; P < .01), and less likely to be in the intensive care unit (40% vs 58%; P < .01) or on inotropes (30% vs 60%; P < .01) at the time of listing. Outcomes including waitlist mortality, transplantation, posttransplant survival, and freedom from rejection were comparable to those of the non-MA cohort., Conclusion: Patients with MA constitute a small proportion of those listed for HTX in childhood. CM was the most common category, while IA and PT were rare. Their waitlist mortality and posttransplant outcomes were comparable to those of the non-MA cohort., Competing Interests: Disclosures Dr Wittlieb-Weber is a consultant for Pfizer (no conflict related to this study). Dr Kirklin is President of Kirklin Solutions, Inc. (no conflict related to this study). The remaining authors have no conflicts to disclose., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)
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- 2024
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21. Early stroke following durable left ventricular assist device (LVAD) implantation: An analysis of the Society of Thoracic Surgeons Intermacs National Database.
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Molina EJ, Goldstein D, Cantor RS, Kanwar MK, Meyer D, Jorde U, Saeed O, Wood K, Rudraraju RR, Lewis S, Kirklin JK, Pagani FD, and Kilic A
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Background: Stroke remains a devastating complication of durable left ventricular assist device (LVAD) therapy. This study evaluated the incidence and risk factors for early stroke within 7 days following LVAD implantation investigating both traditional pre-implant and new intraoperative variables collected by The Society of Thoracic Surgeons (STS) Intermacs National Database., Methods: STS Intermacs was queried for patients undergoing implantation of a fully magnetically levitated centrifugal LVAD between November 25, 2020 and June 30, 2023. STS Intermacs stroke definitions were used to identify patients who suffered a stroke within the first 7 postoperative days (POD). A multivariable logistic regression model was created to generate adjusted odd ratios (OR) for variables associated with early stroke., Results: Among 6,950 patients in the study cohort, 5.9% (413/6950) developed a stroke after a median follow-up of 11 months, with 50% (205/413) of strokes occurring within 7 days after LVAD implantation. Of the strokes occurring during POD 0-7, 70% (144/205) occurred on POD 0-2. By multivariable analysis, the following factors were associated with early stroke: older age (70 vs 50; OR 1.4, p = 0.0129), white race (OR 1.5, p = 0.0078), pre-implant temporary mechanical circulatory support (MCS) bridge (temporary LVAD only: OR 1.6, extracorporeal membrane oxygenation [ECMO] only: OR 1.7, combination of both devices: OR 3.3; p = 0.0001) and presence of an unremoved left atrial clot (OR 8.0, p < 0.0001)., Conclusions: A significant proportion of strokes occur within the first 7 days following LVAD implantation, particularly within the first 2 days. In addition to pre-implant variables, we identified modifiable intraoperative factors associated with stroke that provide an opportunity for further risk mitigation and improvement in quality of care., (Copyright © 2024. Published by Elsevier Inc.)
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- 2024
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22. Predicting Stroke for Pediatric Patients Supported With Ventricular Assist Devices: A Pedimacs Report.
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Ashfaq A, Lorts A, Rosenthal D, Adachi I, Rossano J, Davies R, Simpson KE, Maeda K, Wisotzkey B, Koehl D, Cantor RS, Jacobs JP, Peng D, Kirklin JK, and Morales DLS
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- Humans, Child, Male, Female, Child, Preschool, Infant, Adolescent, Incidence, Retrospective Studies, Risk Factors, Heart Failure therapy, United States epidemiology, Risk Assessment, Heart-Assist Devices adverse effects, Stroke epidemiology, Stroke etiology, Registries
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Background: The Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) provides detailed understanding on pediatric patients supported with ventricular assist devices (VADs). We sought to identify important variables affecting the incidence of stroke in pediatric VADs., Methods: Between 2012 and 2022, 1463 devices in 1219 patients were reported to Pedimacs from 40 centers in patients aged <19 years at their first VAD implantation. Multiphase parametric hazard modeling was used to identify risk factors for stroke among all device types., Results: Of the 1219 patients, the most common devices were implantable continuous (472 [39%]), followed by paracorporeal pulsatile (342 [28%]), and paracorporeal continuous (327 [27%]). Overall freedom from stroke at 6 months was higher in the recent era (2012-2016; 80.2% [95% CI, 77.1%-82.9%] vs 2017-2023; 87.9% [95% CI, 86.2%-89.4%], P = .009). Implantable continuous VADs had the highest freedom from stroke at 3 months (92.7%; 95% CI, 91.1%-93.9%) and 6 months (91.1%; 95% CI, 89.3%-92.6%), followed by paracorporeal pulsatile (87.0% [95% CI, 84.8%-88.9%] and 82.8% [95% CI, 79.8%-85.5%], respectively), and paracorporeal continuous (76.0% [95% CI, 71.8%-79.5%] and 69.5% [95% CI, 63.4%-74.8%], respectively) VADs. Parametric modeling identified risk factors for stoke early after implant and later. Overall, and particularly for paracorporeal pulsatile devices, early stroke risk has decreased in the most recent era (hazard ratio, 5.01). Among implantable continuous devices, cardiogenic shock was the major risk factor. For patients <10 kg, early hazard was only seen in the previous era. For congenital patients, early hazard was seen in nonimplantable device use and use of extracorporeal membrane oxygenation., Conclusions: The overall stroke rate has decreased from 20% to 15% at 6 months, with particular improvement among paracorporeal pulsatile devices. Risk factor analyses offer insights for identification of higher stroke risk subsets and further management refinements., Competing Interests: Disclosures Joseph Rossano reports a relationship with Bayer Corporation that includes: consulting or advisory; with Merck & Co Inc that includes: consulting or advisory; with Cytokinetics Inc that includes: consulting or advisory; with Bristol-Myers Squibb Co that includes: consulting or advisory; and with American Regent Inc that includes: consulting or advisory. James Kirklin reports a relationship with The Society of Thoracic Surgeons that includes: employment. David Morales reports a relationship with Abbott that includes: consulting or advisory; with Azyio that includes: consulting or advisor; with Xeltis BV that includes: consulting or advisory; with Berlin Heart GmbH that includes: consulting or advisory; with CorMatrix Cardiovascular Inc that includes: consulting or advisory; and with SynCardia Systems LLC that includes: consulting or advisory. The other authors have no conflicts of interest to disclose., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)
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- 2024
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23. Mechanical circulatory support early after pediatric heart transplantation-an analysis from the Pediatric Heart Transplant Society.
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Simmonds J, Zangwill SD, Wisotzkey B, Cantor R, Zhao H, Kirklin JK, and Gupta D
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Background: The use of early mechanical circulatory support (MCS) following pediatric heart transplantation is not well-published. This paper attempts to uncover the incidence, predisposing factors, and outcomes of MCS in a large, international cohort., Methods: The Pediatric Heart Transplant Society Database (an international, prospective, event-driven database) was retrospectively analyzed for all cases of primary heart transplant over an 11-year period (2010-2020), dividing the cohort based on need for MCS within 30 days of transplantation., Results: Of 4,321 primary transplants, 249 (5.8%) required MCS (230 ECMO (Extracoporeal Membranous Oxygenation), 19 ventricular assist device). In a Cox proportional hazard model, congenital heart disease (p = 0.0002), older donor age (p < 0.0001), and longer ischemic time (p = 0.018) were each related to an increased need for MCS; increasing recipient body surface area (p < 0.0001) and increasing donor left ventricular ejection fraction (p = 0.016) were both correlated with less MCS use. One-year survival in those requiring MCS was 54.2%, compared with 94.8% in those who did not need MCS (p < 0.0001). Later survival in patients surviving to 1 year was similar between the groups., Conclusions: MCS is used infrequently following pediatric heart transplant and is related to donor, recipient, and transplant factors. Although mortality is high, those surviving the first year post transplant have excellent outcomes. Judicious use in those patients who would otherwise perish is therefore justified., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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24. Association of Novel Ventricular Assist Device Self-report Measures With Overall Health-Related Quality of Life.
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Grady KL, Burns JL, Allen LA, Stehlik J, Teuteberg J, McIlvennan CK, Kirklin JK, Beiser DG, Lindenfeld J, Denfeld QE, Lee CS, Kiernan M, Cella D, Klein L, Walsh MN, Ruo B, Adler E, Rich J, Pham DT, Yancy C, Murks C, Bedjeti K, and Hahn EA
- Abstract
Background: Few study authors examined factors influencing health-related quality of life (HRQOL) early after left ventricular assist device (LVAD) implantation., Objective: The purpose of this study was to determine whether 5 novel self-report measures and other variables were significantly associated with overall HRQOL at 3 months after LVAD surgery., Methods: Patients were recruited between October 26, 2016, and February 29, 2020, from 12 US sites. Data were collected before LVAD implantation and at 3 months post LVAD implantation. Overall HRQOL measures included the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) overall summary score (OSS) and EuroQol 5-dimension- 3L visual analog scale. Potential factors associated with overall HRQOL included 5 novel self-report measures (Satisfaction with Treatment, Being Bothered by VAD Self-care and Limitations, VAD Team Communication, Self-efficacy regarding VAD Self-care, and Stigma), and demographic and clinical characteristics. Statistics included regression analyses., Results: Of enrollees, 242 completed self-report measures at baseline, and 142 completed measures 3 months postoperatively. Patients were 55 ± 13 years old, with 21% female, 24% non-White, 39% high school or lower educated, and 47% destination therapy. Using the KCCQ-12 OSS, higher Satisfaction with Treatment was associated with a higher KCCQ-12 OSS; Being Bothered by VAD Self-care and Limitations, high school or lower education, chest incision pain, cardiac dysrhythmias within 3 postoperative months, and peripheral edema were associated with a worse KCCQ-12 OSS (R2 = 0.524). Factors associated with a worse 3-month EuroQol 5-dimension-3L visual analog scale were female sex, adverse events within 3 months post implantation (cardiac dysrhythmias, bleeding, and venous thrombosis), and chest incision pain (R2 = 0.229). No factors were associated with a higher EuroQol 5-dimension-3L visual analog scale score at 3 months., Conclusions: Two novel measures, demographics, postimplantation adverse events, and symptoms were associated with post-LVAD KCCQ-12 OSS early after surgery., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2024
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25. Clinical outcomes after a biopsy diagnosis of antibody-mediated rejection in pediatric heart transplant recipients.
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Everitt MD, Pahl E, Koehl DA, Cantor RS, Kirklin JK, Reed AC, Thrush P, Zinn M, McCormick AD, Yester J, Schauer JS, and Lee DW
- Abstract
Background: Extending survival after heart transplant (HT) is of paramount importance for childhood recipients of HT. Acute rejection is a significant event, and biopsy remains the most specific means for distinguishing between cellular (ACR) and antibody-mediated rejection (AMR)., Methods: All children in the Pediatric Heart Transplant Society Registry who underwent HT between January 2015 and June 2022 and had ≥1 rejection episode were included. Survival was compared between AMR and ACR-only. Secondary outcomes of infection, malignancy, and cardiac allograft vasculopathy (CAV) were assessed. Risk factors for graft loss after AMR were identified using Cox proportional hazard modeling., Results: Among 906 children with rejection, 697 (77%) with complete biopsy information were included. AMR was present on biopsy in 261 (37%) patients; ACR-only was present in 436 (63%). Time to rejection was earlier for AMR, median time from HT to rejection 0.11 versus 0.29 years, p = 0.0006. Survival after AMR in the 1st year was lower than survival after ACR-only. Predictors of graft loss after AMR were younger age at HT, congenital heart disease, and rejection with hemodynamic compromise. There was no difference in time to CAV, infection, or malignancy after rejection between groups., Conclusions: The largest analysis of pediatric HT rejection with biopsy data to identify AMR underscores the continued importance of AMR on survival. AMR is associated with higher graft loss versus ACR when occurring in the first-year post-HT. Predictors of graft loss after AMR identify patients who may benefit from increased surveillance or augmented maintenance immunosuppression., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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26. The World Society for Pediatric and Congenital Heart Surgery: 2024 Update of the World Database for Pediatric and Congenital Heart Surgery.
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St Louis JD, Collum CS, Pennington JK, Broser T, Rudraraju R, Cleggett M, Love JA, Potter P, Bateson B, Juaneda I, Cervantes JL, Lee C, Jacobs JP, Austin EH, and Kirklin JK
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- Humans, Child, Global Health statistics & numerical data, Pediatrics statistics & numerical data, Heart Defects, Congenital surgery, Heart Defects, Congenital mortality, Cardiac Surgical Procedures statistics & numerical data, Cardiac Surgical Procedures mortality, Databases, Factual, Societies, Medical statistics & numerical data
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Background: The World Database for Pediatric and Congenital Heart Surgery (WDPCHS), sponsored by the World Society for Pediatric and Congenital Heart Surgery (WSPCHS), provides complex congenital heart surgery outcomes analyses for member programs. This report represents the seven-year descriptive analysis of outcomes from active members of the WDPCHS., Methods: Individual institutions submit data based on the specific procedure via a password protected platform. The data are collected, stored, and analyzed at Kirklin Solutions Inc., based in Birmingham, Alabama. This report presents a descriptive analysis of these procedures submitted from January 1, 2017, to December 31, 2023., Results: A total of 50,174 procedures were submitted with an overall mortality of 4.6%. The majority of submissions were from Asian countries. The majority of cases submitted from these countries were of STAT mortality category I and II. Repair of a ventricular septal defect (with a mortality of 0.8%) and correction of tetralogy of Fallot (2.0% mortality) were the most common procedures submitted to the database., Conclusions: The WSPCHS accomplished one of its missions in 2017 when the WDPCHS began accepting data from pediatric and congenital heart surgery programs across the globe. In doing so, it became one of the first organizations to create a platform for the exchange of knowledge and experience, regardless of the socioeconomic status of the particular program or country., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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- 2024
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27. A comparison of quality-adjusted life years in older adults after heart transplantation versus long-term mechanical support: Findings from the SUSTAIN-IT study.
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Grady KL, Dew MA, Pagani FD, Spertus JA, Hsich E, Yuzefpolskaya M, Lampert B, Kirklin JK, Petty M, Kao A, Yancy C, Hartupee J, Pamboukian SV, Johnson M, Murray M, Wu T, and Andrei AC
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- Humans, Male, Female, Aged, Middle Aged, Aged, 80 and over, Time Factors, Follow-Up Studies, Survival Rate trends, United States epidemiology, Age Factors, Heart Transplantation, Quality-Adjusted Life Years, Heart Failure surgery, Heart Failure therapy, Quality of Life, Heart-Assist Devices
- Abstract
Background: The quality-adjusted life year (QALY) measures disease burden and treatment, combining overall survival and health-related quality of life (HRQOL). We estimated QALYs in 3 groups of older patients (60-80 years) with heart failure (HF) who underwent heart transplantation (HT, with pre-transplant mechanical circulatory support [HT MCS] or HT without pre-transplant MCS [HT Non-MCS]) or long-term MCS (destination therapy). We also identified factors associated with gains in QALYs through 24 months follow-up., Methods: Of 393 eligible patients enrolled (10/1/15-12/31/18) at 13 U.S. sites, 161 underwent HT (n = 68 HT MCS, n = 93 HT Non-MCS) and 144 underwent long-term MCS. Survival and HRQOL data were collected through 24 months. QALY health utilities were based on patient self-report of EQ-5D-3L dimensions. Mean-restricted QALYs were compared among groups using generalized linear models., Results: For the entire cohort, mean age in years closest to surgery was 67 (standard deviation, SD: 4.7), 78% were male, and 83% were White. By 18 months post-surgery, sustained significant differences in adjusted average ± SD QALYs emerged across groups, with the HT Non-MCS group having the highest average QALYs (24-month window: HT Non-MCS = 22.58 ± 1.1, HT MCS = 19.53 ± 1.33, Long-term MCS = 19.49 ± 1.3, p = 0.003). At 24 months post-operatively, a lower gain in QALYs was associated with HT MCS, long-term MCS, a lower pre-operative LVEF, NYHA class III or IV before surgery, and an ischemic or other etiology of HF., Conclusions: Determination of QALYs may provide important information for policy makers and clinicians to consider regarding benefits of HT and long-term MCS as treatment options for older patients with HF., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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28. Social Determinants of Health and Outcomes After Pediatric Ventricular Assist Device Implantation.
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West CL, Zhao H, Cantor R, Sood V, Lal AK, Beaty C, Kirklin JK, and Peng DM
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- Humans, Female, Male, Child, Child, Preschool, Infant, Adolescent, Retrospective Studies, Kaplan-Meier Estimate, Treatment Outcome, United States epidemiology, Proportional Hazards Models, Infant, Newborn, Heart-Assist Devices, Social Determinants of Health, Heart Failure surgery, Heart Failure therapy, Registries
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Background: Limited research exists on the influence of social determinants of health (SDOH) on outcomes in pediatric patients with advanced heart failure receiving mechanical circulatory support., Methods: Linkage of the Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) and Society of Thoracic Surgeon's Congenital Heart Surgery Database (STS-CHSD) identified pediatric patients who underwent ventricular assist device (VAD) implantation from 2012 to 2022 with available residential zip codes. Utilizing the available zip codes, each patient was assigned a Childhood Opportunity Index (COI) score. Level of childhood opportunity, race, and insurance type were used as proxies for SDOH. Major outcomes included death, transplant, alive with device, and recovery. Secondary outcomes were adverse events. Statistical analyses were performed using the Kaplan-Meier survival, competing risk analyses, and multivariable Cox proportional hazards model., Results: Three hundred seventeen patients were included in the study. Childhood opportunity level and insurance status did not significantly impact morbidity or mortality after VAD implantation. White race was associated with reduced 1-year survival (71% in White vs. 87% in non-White patients, p = 0.05) and increased risk of pump thrombosis (p = 0.02)., Conclusion: Childhood opportunity level and insurance status were not linked to morbidity and mortality in pediatric patients after VAD implantation. Notably, White race was associated with higher mortality rates. The study underscores the importance of considering SDOH in evaluating advanced therapies for pediatric heart failure and emphasizes the need for accurate socioeconomic data collection in future studies and national registries., (© 2024 Wiley Periodicals LLC.)
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- 2024
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29. Efficient measurement of multiple ventricular assist device patient-reported outcomes: Creation of a 20-item profile from the MCS A-QOL study.
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Grady KL, Kallen MA, Cella D, Allen LA, Lindenfeld J, McIlvennan CK, Beiser DG, Walsh MN, Denfeld QE, Lee CS, Ruo B, Murks C, Stehlik J, Kirklin JK, Teuteberg J, Adler E, Kiernan M, Rich J, Bedjeti K, and Hahn EA
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- Humans, Male, Cross-Sectional Studies, Female, Middle Aged, Adult, Surveys and Questionnaires, Aged, Heart-Assist Devices, Patient Reported Outcome Measures, Quality of Life, Heart Failure surgery, Heart Failure therapy, Heart Failure psychology
- Abstract
Background: Patient-reported outcome (PRO) measures of distinct concepts are often put together into patient profile assessments. When brief, profile assessments can decrease respondent burden and increase measure completion rates. In this report, we describe the creation of 5 self-reported 4-item short forms and the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL) 20-item profile to assess PROs specific to adjustment and health-related quality of life (HRQOL) among patients who undergo left ventricular assist device (LVAD) implantation., Methods: Using a cross-sectional sample of patients (n = 620) who underwent LVAD implantation at 12 U.S. sites or participated in the MyLVAD.com support group, we created 5 4-item short forms: Satisfaction with Treatment, ventricular assist device (VAD) Team Communication, Being Bothered by VAD Self-care and Limitations, Self-efficacy Regarding VAD self-care, and Stigma, which we combined into a 20-item profile. Analyses included intercorrelations among measures, Cronbach's alpha (i.e., internal consistency reliability)/score-level-specific reliability, and construct validity., Results: The 620 patients were mean age = 57 years, 78% male, 70% White, and 56% on destination therapy LVADs. Intercorrelations among the 5 4-item measures were low to moderate (≤0.50), indicating they are associated yet largely distinct, and correlations with calibrated measures and 6-item short forms were ≥0.76, indicating their ability to reflect full-item bank scores. Internal consistency reliability for the 5 4-item short forms ranged from acceptable (≥0.70) to good (≥0.80). Construct validity was demonstrated for these measures., Conclusions: Our 5 4-item short forms are reliable and valid and may be used individually or together as a 20-item profile to assess adjustment and HRQOL in patients who undergo LVAD implantation., Competing Interests: Disclosure statement Kathleen L. Grady, PhD, RN – NIH Grants (NIA and NHLBI) and payment of room reservation by NIH as faculty at the Ten-day Seminar; lecturer (registration fees paid for meeting: Heart Failure Society of America, American Heart Association, International Society for Heart and Lung Transplantation, and American College of Cardiology); leadership or fiduciary role (ISHLT Board of Directors, Foundation Board, Research Oversight Committee, Governance Committee, Leadership Advisory Forum, and chair, Grants and Awards Committee). Michael Kallen, PhD – Deceased; ICMJE Disclosure Form not completed. Larry A. Allen, MD, MHS – Grant from PCORI and NIH; Consultant for ACI Clinical, Boston Scientific, Cytokinetics, Novartis, UpToDate, and Quidel. JoAnn Lindenfeld, MD –Consulting fees from Abbott, Alleviant, Axon, Astra Zenaca, Boston Scientific, CVRx, Merck, Medtronic, VWave, Edwards Lifesciences, Whiteswell, and Vascular Dynamicx. Colleen K. McIlvennan, PhD, DNP, ANP – Grant from PCORI and Cambia Health Foundation; HFSA Board of Directors. Christopher S. Lee, PhD, RN – DSMB chair: COMBAT-DS; US Department of Health and Human Services: National Advisory Council (member). Josef Stehlik, MD – Grants from Natera and Merck and consulting for Medtronic, Natera, and TransMedics. James K. Kirklin, MD – Intellectual properties for IT software development in registry database design developed at and licensed from the University of Alabama at Birmingham; chair of DSMB for Xeltis cardiac conduit clinical trial, chair of DSMB for Carmat TAH clinical trial, chair XVIVO Clinical Safety Monitoring Board; President World Society for Pediatric and Congenital Heart Surgery; common stock in Kirklin Solutions Co. Database development and analytics (20% ownership; $3.75 per share; current market value $700,000); partial salary support as Director of the Data Center for STS Intermacs/Pedimacs (no payments for any of these roles related to this publication). Jeffrey Teuteberg, MD – Consultant for Abbott, CareDx, Medtronic and Takeda; Lecturer for CareDx, Cytokinetics, Medtronic, and Paragonix. Eric Adler, MD – Grants from Lexeo Therapeutics, Rocket Pharmaceuticals, and California Institute for Regenerative Medicines; Royalties or licenses from Lexeo Therapeutics, Rocket Pharmaceuticals, and Papillion Therapeutics; consulting fees from Abiomed, Norvartis, Abbott, Ionis, Kiniska, Sana, Medtronic, and Cytokinetics; payment for expert testimony on behalf of Astro Zeneca; patents planned, issued or pending: Method for treating Danon disease and other disorders of autophagy and ex vivo genetic modification of hematopoietic cells for the treatment of Danon Disease; participation on DSMB: Edwards Lifesciences, Ancora Heart, and Corstasis Therapeutics; leadership or fiduciary role: Chief Science Officer for Lexeo Therapeutics, Scientific Advisory Board for Sarnoff Foundation, and Board of Directors for Papillion Therapeutics; stock or stock options: Rocket Pharmaceuticals, Lexeo Therapeutics, Corstasis Therapeutics, and Papillion Therapeutics. Michael Kiernan, MD – Steering Committee: Medtronic and Endotronix. The other authors have no conflicts of interest to disclose. Michael Kallen, PhD, MPH, coauthor and statistician/psychometrician for MCS A-QOL and this paper, passed away on July 27, 2023. His contributions to this manuscript were substantial and his passion for the development of patient-reported outcome measures was inspiring. He was a kind and gentle person who is genuinely missed by Beth Hahn, my co-PI on MCS A-QOL, and me. Words cannot adequately express our deep sense of gratitude and loss. This work was sponsored by the National Institutes of Health, National Heart Lung and Blood Institute (NHLBI), Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL, [R01HL130502], Grady K.L. and Hahn E.A. [co-PIs])., (Copyright © 2024. Published by Elsevier Inc.)
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- 2024
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30. Waitlist Outcomes for Pediatric Heart Transplantation in the Current Era: An Analysis of the Pediatric Heart Transplant Society Database.
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Butts RJ, Toombs L, Kirklin JK, Schumacher KR, Conway J, West SC, Auerbach S, Bansal N, Zhao H, Cantor RS, Nandi D, and Peng DM
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- Humans, Child, Male, Female, Child, Preschool, Infant, Adolescent, Risk Factors, Treatment Outcome, Infant, Newborn, Heart Transplantation mortality, Waiting Lists mortality, Databases, Factual
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Background: Waitlist mortality (WM) remains elevated in pediatric heart transplantation. Allocation policy is a potential tool to help improve WM. This study aims to identify patients at highest risk for WM to potentially inform future allocation policy changes., Methods: The Pediatric Heart Transplant Society database was queried for patients <18 years of age indicated for heart transplantation between January 1, 2010 to December 31, 2021. Waitlist mortality was defined as death while awaiting transplant or removal from the waitlist due to clinical deterioration. Because WM is low after the first year, analysis was limited to the first 12 months on the heart transplant list. Kaplan-Meier analysis and log-rank testing was conducted to compare unadjusted survival between groups. Cox proportional hazard models were created to determine risk factors for WM. Subgroup analysis was performed for status 1A patients based on body surface area (BSA) at time of listing, cardiac diagnosis, and presence of mechanical circulatory support., Results: In total 5974 children met study criteria of which 3928 were status 1A, 1012 were status 1B, 963 were listed status 2, and 65 were listed status 7. Because of the significant burden of WM experienced by 1A patients, further analysis was performed in only patients indicated as 1A. Within that group of patients, those with smaller size and lower eGFR had higher WM, whereas those patients without congenital heart disease or support from a ventricular assist device (VAD) at time of listing had decreased WM. In the smallest size cohort, cardiac diagnoses other than dilated cardiomyopathy were risk factors for WM. Previous cardiac surgery was a risk factor in the 0.3 to 0.7 m
2 and >0.7 m2 BSA groups. VAD support was associated with lower WM other than in the single ventricle cohort, where VAD was associated with higher WM. Extracorporeal membrane oxygenation and mechanical ventilation were associated with increased risk of WM in all cohorts., Conclusions: There is significant variability in WM among status-1A patients. Potential refinements to current allocation system should factor in the increased WM risk we identified in patients supported by extracorporeal membrane oxygenation or mechanical ventilation, single ventricle congenital heart disease on VAD support and small children with congenital heart disease, restrictive cardiomyopathy, or hypertrophic cardiomyopathy., Competing Interests: None.- Published
- 2024
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31. Impact of prolonged ischemic time on pediatric heart transplantation outcomes: Improved outcomes in the most recent era.
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Auerbach SR, Arshad A, Azeka E, Cantor RS, Kirklin JK, Koehl D, Menteer J, Peng DM, Ravekes W, Shaw FR, Shih R, Simmonds J, and Ballweg J
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- Humans, Male, Female, Child, Child, Preschool, Infant, Time Factors, Adolescent, Retrospective Studies, Graft Rejection epidemiology, Heart Defects, Congenital surgery, Treatment Outcome, Follow-Up Studies, Risk Factors, Survival Rate trends, Heart Transplantation, Graft Survival
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Background: Impacts of ischemic time (IT) on pediatric heart transplant outcomes are multifactorial. We aimed to analyze the effect of prolonged IT on graft loss after pediatric heart transplantation. We hypothesized that graft survival with prolonged IT has improved across eras., Methods: Patients <18 years old in the Pediatric Heart Transplant Society database were included (N=6,765) and stratified by diagnosis and era (1993-2004, 2005-2009, and 2010-2019). Severe graft failure (SGF) was defined as death, retransplant, or need for mechanical circulatory support in the first 7 days post-transplant. Descriptive statistical methods were used to compare differences between patient characteristics and IT. Kaplan-Meier survival analysis compared freedom from graft loss, rejection, and infection. Multivariable analysis was performed for graft loss and SGF (hazard and logistic regression modeling, respectively)., Results: Diagnoses were cardiomyopathy (N = 3,246) and congenital heart disease (CHD; N = 3,305). CHD were younger, more likely to have an IT ≥4.5 hours, and more likely to require extracorporeal membrane oxygenation or mechanical ventilation at transplant (all p < 0.001). Median IT was 3.6 hours (interquartile range 2.98-4.31; range 0-10.5). IT was associated with early graft loss (HR 1.012, 95% CI 1.005-1.019), but not when analyzed only in the most recent era. IT was associated with SGF (OR 1.016 95%CI 1.003-1.030)., Conclusions: Donor IT was independently associated with an increased risk of graft loss, albeit with a small effect relative to other risk factors. Graft survival with prolonged IT has improved in the most recent era but the risk of SGF persists., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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32. Uncertain benefit of statins in pediatric heart transplant recipients: A PHTS analysis.
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Townsend M, Khoury M, Koehl D, Kirklin JK, Cantor R, Beasley G, Chen CY, Boyle G, Parent JJ, Baez Hernandez N, and Halnon N
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- Humans, Child, Male, Female, Adolescent, Child, Preschool, Retrospective Studies, Incidence, Graft Rejection prevention & control, Graft Rejection epidemiology, Infant, Follow-Up Studies, Postoperative Complications prevention & control, Postoperative Complications epidemiology, Heart Transplantation, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Graft Survival drug effects
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Background: Cardiac allograft vasculopathy (CAV) is a leading cause of graft failure in pediatric heart transplant recipients (HTRs). Early statin use has been shown to reduce CAV incidence and all-cause mortality in adult HTRs. We sought to evaluate the contemporary prevalence and trends of statin use in pediatric HTRs and the association between statin use with CAV development and graft failure., Methods: Patients aged <17 years at the time of primary heart transplant who survived to ≥3 years without CAV were identified from the Pediatric Heart Transplant Society database (2001-2018). Statin use in the first 3 years posttransplant was defined as consecutive, intermediate, or absent. Kaplan-Meier survival, multivariable modeling, and propensity score-matched analyses evaluated associations between statin use and CAV incidence and graft survival, with subanalyses performed on subjects aged ≥10 years at transplant., Results: Among 3,485 (of which 1,086 aged ≥10 years) HTRs, 584 (17%) received consecutive statin therapy, 647 (19%) received intermediate use, and 2,254 (65%) received no statin therapy. Statin use varied widely between sites, with increasing use in the ≥10-year-old cohort over time. By multivariate analysis, statin use was not associated with graft loss. Consecutive statin use was also not associated with graft survival or freedom from CAV development when compared to absent statin use in unmatched or propensity-matched analyses., Conclusions: While statins remain commonly utilized in pediatric HTRs, early consecutive statin therapy did not decrease CAV incidence or graft loss. The differing effects of statins on CAV development and progression in pediatric vs adult HTRs suggest differing risk and mediating factors and require further study., (Copyright © 2023 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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33. Changing Strategy Between Bridge to Transplant and Destination LVAD Therapy After the First 3 Months: Analysis of the STS-INTERMACS Database.
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Rali AS, Inampudi C, Zalawadiya S, Shah A, Teuteberg JJ, Stewart GC, Cantor RS, Deng L, Jacobs JP, Kirklin JK, and Stevenson LW
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- Humans, Gastrointestinal Hemorrhage etiology, Time Factors, Treatment Outcome, Retrospective Studies, Heart Failure epidemiology, Heart Failure surgery, Heart Transplantation adverse effects, Heart-Assist Devices adverse effects
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Background: Left ventricular assist devices (LVADs) have been implanted as bridge to transplantation (BTT), bridge to candidacy (BTC) or destination therapy (DT) on the basis of relative and absolute contraindications to transplantation. Multiple factors may lead to changes in the strategy of support after LVAD implantation., Methods: Based on INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) 2012-2020 data, 11,262 patients survived to 3 months on continuous-flow LVADs with intent of BTT or DT. Preimplant characteristics and early events post-LVAD were analyzed in relation to changes in BTT or DT strategy during the next 12 months., Results: Among 3216 BTT patients at 3 months, later transplant delisting or death without transplant occurred in 536 (16.7%) and was more common with age, profiles 1-2, renal dysfunction, and independently for prior cardiac surgery (HR 1.25, 95% CI 1.04-1.51; P = 0.02). Post-LVAD events of infections, gastrointestinal bleeding, stroke, and right heart failure as defined by inotropic therapy, predicted delisting and death, as did in-hospital location at 3 months (HR 1.67, 95% CI 1.20-2.33; P = 0.0024). Of 8046 patients surviving to 3 months with the intent of destination therapy, 750 (9.3%) subsequently underwent listing or transplantation, often with initial histories of acute HF (HR 1.70, 95% CI 1.27-2.27; P = 0.0012) or malnutrition-cachexia (1.73, 95% CI 1.14-2.63; P = 0.0099). Multiple gastrointestinal bleeding events (≥ 4) with LVAD increased transition from BTT to DT (HR 4.22, 95% CI 1.46-12.275; P = 0.0078) but also from DT to BTT (HR 5.17, 95% CI 1.92-13.9; P = 0.0011)., Conclusions: Implant strategies change over time in relation to preimplant characteristics and adverse events post implant. Preimplant recognition of factors predicting later change in implant strategy will refine initial triage, whereas further reduction of post-LVAD complications will expand options, including eventual consideration of heart transplantation., Competing Interests: DISCLOSURES None of the authors have any conflicts of interest pertaining to this manuscript. No external funding was received for this project., (Copyright © 2023 Elsevier Inc. All rights reserved.)
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- 2024
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34. Seventh Annual Society of Thoracic Surgeons Pedimacs Report.
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Peng DM, Davies RR, Simpson KE, Shugh SB, Morales DLS, Jacobs JP, Butto A, Joong A, Conway J, Schindler K, Griffiths ER, Koehl D, Cantor RS, Kirklin JK, Rossano JW, and Adachi I
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- Child, Humans, Treatment Outcome, Registries, Retrospective Studies, Heart Failure surgery, Heart Transplantation, Heart Defects, Congenital, Heart-Assist Devices, Surgeons
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Background: The Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs), supported by The Society of Thoracic Surgeons, provides detailed information on pediatric patients supported with ventricular assist devices (VADs)., Methods: From September 19, 2012, to December 31, 2022, 1463 devices in 1219 patients aged <19 years were reported to the registry from 40 North American hospitals., Results: Cardiomyopathy remains the most common underlying etiology (59%), followed by congenital heart disease (26%) and myocarditis (8%). Implantable continuous devices were most common (39%) type, followed by paracorporeal pulsatile (28%) and paracorporeal continuous (27%) devices. At 6 months after VAD implantation, a favorable outcome (transplant, recovery, or alive on device) was achieved in 85% of patients, which was greatest among those on implantable continuous VADs (92%) and least for paracorporeal continuous VADs (68%), although the patient population supported on these devices is different., Conclusions: This Seventh Pedimacs Report demonstrates the continued importance of VADs in the treatment of children. With the complexity of cardiac physiologies and sizes of patients, multiple types of devices are used, including paracorporeal continuous, paracorporeal pulsatile, and implantable continuous devices. The preoperative risk factors and differences in patient populations may account for some of the differences in survival observed among these devices. This report, along with other collaborative work, continues to advance the care of this challenging and vulnerable population., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)
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- 2024
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35. Three decades of collaboration through the Pediatric Heart Transplant Society Registry: A journey through registry data with a highlight on children with single ventricle anatomy.
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Richmond ME, Conway J, Kirklin JK, Cantor RS, Koehl DA, Lal AK, McDonald N, Gajarski R, Lin KY, Singh RK, Fenton M, Asante-Korang A, Amdani S, Auerbach SR, and Everitt MD
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- Child, Humans, Adolescent, Routinely Collected Health Data, Registries, Waiting Lists, Retrospective Studies, Heart Transplantation, Cardiomyopathies, Heart Defects, Congenital surgery, Univentricular Heart
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Background: The Pediatric Heart Transplant Society (PHTS) Registry was founded 30 years ago as a collaborative effort among like-minded providers of this novel life-saving technique for children with end-stage heart failure. In the intervening decades, the data from the Registry have provided invaluable knowledge to the field of pediatric heart transplantation. This report of the PHTS Registry provides a comprehensive look at the data, highlighting both the longevity of the registry and one unique aspect of the PHTS registry, allowing for exploration into children with single ventricle anatomy., Methods: The PHTS database was queried from January 1, 1993 to December 31, 2019 to include pediatric (age < 18 years) patients listed for HT. For our analysis, we primarily analyzed patients by era. The early era was defined as children listed for HT from January 1, 1993 to December 31, 2004; middle era January 1, 2005 to December 31, 2009; and recent era January 1, 2010 to December 31, 2019. Outcomes after listing and transplant, including mortality and morbidities, are presented as unadjusted for risk, but compared across eras., Results: Since 1993, 11 995 children were listed for heart transplant and entered into the PHTS Registry with 9755 listed during the study period. The majority of listings occurred within the most recent era. Waitlist survival improved over the decades as did posttransplant survival. Other notable changes over time include fewer patients experiencing allograft rejection or infection after transplant. Waitlist and posttransplant survival have changed dramatically in patients with single ventricle physiology and significantly differ by stage of single ventricle palliation., Summary: Key points from this PHTS Registry summary and focus on patients with single ventricle congenital heart disease in particular, include the changing landscape of candidates and recipients awaiting heart transplant. There is clear improvement in waitlist and transplant outcomes for children with both cardiomyopathy and congenital heart disease alike., (© 2023 Wiley Periodicals LLC.)
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- 2024
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36. Reply: Is Total Cardiac Volume Optimal for Pediatric Cardiac Transplant Donor-Recipient Matching?
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Amdani S, Koehl D, Cantor R, and Kirklin JK
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- Child, Humans, Cardiac Volume, Tissue Donors, Heart, Retrospective Studies, Graft Survival, Heart Failure surgery, Heart Transplantation
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- 2024
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37. Assessing Donor-Recipient Size Mismatch in Pediatric Heart Transplantation: Lessons Learned From Over 7,500 Transplants.
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Amdani S, Aljohani OA, Kirklin JK, Cantor R, Koehl D, Schumacher K, Nandi D, Khoury M, Dreyer W, Rose-Felker K, Nasman C, and Kemna MS
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- Humans, Child, Retrospective Studies, Tissue Donors, Graft Survival, Tissue and Organ Procurement, Heart Failure, Heart Transplantation
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Background: To date, no studies have identified an optimal metric to match donor-recipient (D-R) pairs in pediatric heart transplantation (HT)., Objectives: This study sought to identify size mismatch metrics that predicted graft survival post-HT., Methods: D-R pairs undergoing HT in Pediatric Heart Transplant Society database from 1993 to 2021 were included. Effects of size mismatch by height, weight, body mass index, body surface area, predicted heart mass, and total cardiac volume (TCV) on 1- and 5-year graft survival and morbidity outcomes (rejection and cardiac allograft vasculopathy) were evaluated. Cox models with stepwise selection identified size metrics that independently predicted graft survival., Results: Of 7,715 D-R pairs, 36.0% were well matched (D-R ratio: -20% to +20%) by weight, 39.0% by predicted heart mass, 50.0% by body surface area, 57.0% by body mass index, 71.0% by height, and 93.0% by TCV. Of all size metrics, only D-R mismatch by height and TCV predicted graft survival at 1 and 5 years. Effects of D-R size mismatch on graft survival were nonlinear. At both 1 and 5 years post-HT, D-R undersizing and oversizing by height led to increased graft loss, with graft loss observed more frequently with undersizing. Moderately undersized donors by height (D-R ratio: <-30%) frequently experienced rejection post-HT (P < 0.001). Assessing D-R size matching by TCV, minimal donor undersizing was protective, while oversizing up to 25% was not associated with increased graft loss., Conclusions: In pediatric HT, D-R appear most optimally matched using TCV. Only D-R size mismatch by TCV and height independently predicts graft survival. Standardizing size matching across centers may reduce donor discard., Competing Interests: Funding Support and Author Disclosures Dr Amdani is a site principal investigator for a multicenter study led by the University of Michigan (reports no salary support). Dr Kirklin has received partial support as principle investigator of the INTERMACS National Heart, Lung, and Blood Institute–sponsored registry for U.S. mechanical circulatory support (funding paid through institution). 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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38. The Society of Thoracic Surgeons Intermacs 2023 Annual Report: Focus on Magnetically Levitated Devices.
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Jorde UP, Saeed O, Koehl D, Morris AA, Wood KL, Meyer DM, Cantor R, Jacobs JP, Kirklin JK, Pagani FD, and Vega JD
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- Humans, Societies, Medical, Registries, Treatment Outcome, Heart Failure surgery, Heart Failure etiology, Heart-Assist Devices adverse effects, Thrombosis etiology
- Abstract
The 14th Annual Report from The Society of Thoracic Surgeons (STS) Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) describes outcomes of 27,493 patients with a continuous-flow left ventricular assist device (LVAD) from the past decade (2013-2022). In 2022, 2517 primary LVADs were implanted, of which 2512 (99.8%) were fully magnetically levitated (Mag-Lev) devices. This shift to nearly exclusive use of a Mag-Lev device led us to examine its outcomes compared with contemporary (2018-2022) and historical (2013-2017) non-Mag-Lev cohorts. Patients supported by a Mag-Lev device (n = 10,920) had a higher 1- and 5-year survival of 86% (vs 79% and 81%, P < .0001) and 64% (vs 44% and 44%, P < .0001), respectively, than those receiving non-Mag-Lev devices during the contemporary and historical eras. Over 5 years, freedom from gastrointestinal bleeding (72% vs 60%, P < .0001), stroke (87% vs 67%, P < .0001), and device malfunction/pump thrombus (83% vs 54%, P < .0001), but not device-related infection (61% vs 64%, P = .93), was higher with Mag-Lev devices compared with non-Mag-Lev support during the contemporary era. In this large primacy cohort of real-world patients with advanced heart failure, this report underscores marked improvements in short- and intermediate-term survival and reduction of adverse events with a contemporary Mag-Lev LVAD., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)
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- 2024
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39. Primary or Delayed Repair for Complete Atrioventricular Septal Defect, Tetralogy of Fallot, and Ventricular Septal Defect: Relationship to Country Economic Status.
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Bateson BP, Deng L, Ange B, Austin E, Dabal R, Bowser T, Pennington J, Sivakumar S, Lee C, Truong NLT, Jacobs J, Cervantes J, Jagannath BR, Jonas RA, Kirklin JK, and St Louis J
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- Humans, Child, Infant, Economic Status, Treatment Outcome, Retrospective Studies, Tetralogy of Fallot surgery, Heart Septal Defects surgery, Heart Septal Defects, Ventricular surgery
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Objective: Primary repair in the first six months of life is routine for tetralogy of Fallot, complete atrioventricular septal defect, and ventricular septal defect in high-income countries. The objective of this analysis was to understand the utilization and outcomes of palliative and reparative procedures in high versus middle-income countries., Methods: The World Database of Pediatric and Congenital Heart Surgery identified patients who underwent surgery for: tetralogy of Fallot, complete atrioventricular septal defect, and ventricular septal defect. Patients were categorized as undergoing primary repair, repair after prior palliation, or palliation only. Country economic status was categorized as lower middle, upper middle, and high, defined by the World Bank. Multiple logistic regression models were utilized to identify independent predictors of hospital mortality., Results: Economic categories included high (n = 571, 5.3%), upper middle (n = 5,342, 50%), and lower middle (n = 4,793, 49.7%). The proportion of patients and median age with primary repair were: tetralogy of Fallot, 88.6%, 17.7 months; complete atrioventricular septal defect, 83.4%, 7.7 months; and ventricular septal defect, 97.1%, ten months. Age at repair was younger in high income countries ( P < .0001). Overall mortality after repair was lowest in high income countries. Risk factors for hospital mortality included prematurity, genetic syndromes, and urgent or emergent operations (all P < .05)., Conclusions: Primary repair was selected in >90% of patients, but definitive repair was delayed in lower and upper middle income countries compared with high-income countries. Repair after prior palliation versus primary repair was not a risk factor for hospital mortality. Initial palliation continues to have a small but important role in the management of these three specific congenital heart defects., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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- 2024
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40. Novel measures to assess ventricular assist device patient-reported outcomes: Findings from the MCS A-QOL study.
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Grady KL, Kallen MA, Beiser DG, Lindenfeld J, Teuteberg J, Allen LA, McIlvennan CK, Rich J, Yancy C, Lee CS, Denfeld QE, Kiernan M, Walsh MN, Adler E, Ruo B, Stehlik J, Kirklin JK, Bedjeti K, Cella D, and Hahn EA
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- Humans, Male, Middle Aged, Quality of Life, Reproducibility of Results, Patient Reported Outcome Measures, Heart-Assist Devices, Heart Failure surgery
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Background: Generic and heart failure-specific measures do not capture unique aspects of living with a ventricular assist device (VAD). Using state-of-the-science psychometric measurement methods, we developed a measurement system to assess post-ventricular assist device adjustment and health-related quality of life (HRQOL)., Methods: Patients were recruited from 10/26/16-2/29/20 from 12 U.S. VAD programs. We created a dataset of participants (n = 620) enrolled before left (L)VAD implantation, with data at 3- or 6- months post-implantation (group1 [n = 154]), and participants enrolled after LVAD implantation, with data at one timepoint (group 2 [n = 466]). We constructed 5 item banks: 3 modified from existing measures and 2 new measures. Analyses included item response theory (IRT) modeling, differential item functioning tests for systematic measurement bias, and indicators of reliability and validity., Results: Of 620 participants, 56% (n = 345) were implanted as destination therapy, 51% (n = 316) were <12 months post-implantation, mean age = 57.3 years, 78% (n = 485) male, 70% (n = 433) White, 58% (n = 353) married/partnered, and 58% (n = 357) with >high school education. We developed 5 new VAD item banks/measures: 6-item VAD Team Communication; 12-item Self-efficacy Regarding VAD Self-care; 11-item Being Bothered by VAD Self-care and Limitations; 7-item Satisfaction with Treatment; and 11-item Stigma. Cronbach's alpha reliability ranged from good (≥0.80) to excellent (≥0.90) for item banks/measures. All measures, except VAD Team Communication, demonstrated at least moderate correlations (≥0.30) with construct validity indicators., Conclusions: These measures meet IRT modeling assumptions and requirements; scores demonstrate reliability and validity. Use of these measures may assist VAD clinicians to inform patients about VADs as a treatment option and guide post-VAD interventions., (Copyright © 2023 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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41. Risk factors for 1-year allograft loss in pediatric heart transplant patients using machine learning: An analysis of the pediatric heart transplant society database.
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Wisotzkey BL, Jaeger B, Asante-Korang A, Brickler M, Cantor RS, Everitt MD, Kirklin JK, Koehl D, Mantell BS, Thrush PT, and Kuhn M
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- Humans, Child, Risk Factors, Risk Assessment, Machine Learning, Allografts, Heart Transplantation, Heart Defects, Congenital
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Background: Pediatric heart transplant patients are at greatest risk of allograft loss in the first year. We assessed whether machine learning could improve 1-year risk assessment using the Pediatric Heart Transplant Society database., Methods: Patients transplanted from 2010 to 2019 were included. The primary outcome was 1-year graft loss free survival. We developed a prediction model using cross-validation, by comparing Cox regression, gradient boosting, and random forests. The modeling strategy with the best discrimination and calibration was applied to fit a final prediction model. We used Shapley additive explanation (SHAP) values to perform variable selection and to estimate effect sizes and importance of individual variables when interpreting the final prediction model., Results: Cumulative incidence of graft loss or mortality was 7.6%. Random forests had favorable discrimination and calibration compared to Cox proportional hazards with a C-statistic (95% confidence interval [CI]) of 0.74 (0.72, 0.76) versus 0.71 (0.69, 0.73), and closer alignment between predicted and observed risk. SHAP values computed using the final prediction model indicated that the diagnosis of congenital heart disease (CHD) increased 1 year predicted risk of graft loss by 1.7 (i.e., from 7.6% to 9.3%), need for mechanical circulatory support increased predicted risk by 2, and single ventricle CHD increased predicted risk by 1.9. These three predictors, respectively, were also estimated to be the most important among the 15 predictors in the final model., Conclusions: Risk prediction models used to facilitate patient selection for pediatric heart transplant can be improved without loss of interpretability using machine learning., (© 2023 Wiley Periodicals LLC.)
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- 2023
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42. Widening care gap in VAD therapy.
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Conway J, Amdani S, Morales DLS, Lorts A, Rosenthal DN, Jacobs JP, Rossano J, Koehl D, Kirklin JK, and Auerbach SR
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- Young Adult, Child, Humans, Aged, Adult, Treatment Outcome, Retrospective Studies, Heart Failure surgery, Heart Failure etiology, Heart-Assist Devices adverse effects, Heart Transplantation, Stroke etiology
- Abstract
Background: The removal of the HeartWare ventricular assist device (HVAD) due to pump malfunctions and inferior outcomes compared to HeartMate 3 (HM3) in adults has created a care gap for younger patients. It is unclear if the reported HVAD survival differs by age and if the initial experience with HM3 can bridge the gap., Methods: Using the Society of Thoracic Surgeons (STS) Intermacs and Pedimacs registries, durable ventricular assist device (VAD) implants between September 2012 and December 2021 were identified. Young adults (YA) were defined as <40 years old in Intermacs. Patients were excluded if they had an isolated right VAD (RVAD) or were implanted as destination therapy (DT). Survival analysis by Kaplan-Meier (KM) and competing outcomes curves was performed, and 1-year survival is reported., Results: The Intermacs cohort consisted of YA (n = 1226; HVAD 818; HM3 408) with a median age of YA of 32.07 (26.66-36.27) years and weight (wt) of 83.2 (68-104.2) kg. Most had cardiomyopathy (CM) (92.2%). The Pedimacs cohort was 668 patients (median age 9.47 [1.82-14.23] years, wt 27.2 [10-57.05] kg), and most also had CM (70.5%). Device breakdown included HVAD (n = 326), Berlin EXCOR (n = 277), and HM3 (n = 65). HVAD survival differed by age in adults, with YA fairing better than adults >40 years old (88.8% vs 79.4% at 1 year, p < 0.0001). YA survival was also better compared to Pedimacs patient (88.9% vs 83.7%, p = 0.0002), but when competing events were analyzed, mortality was similar to YA (9.2% vs 9.6%, p = 0.1) with a higher proportion of patient undergoing transplant at 1 year in Pedimacs (74% vs 31.3%, p < 0.0001). Survival by device differed between HVAD and HM3 in YA (88.8% vs 94.4%, p = 0.0025). This difference in device survival was not seen in all children (83.7% vs 87.3%, p = 0.21), including those ≥25 kg. Adverse event profiles also differed across the groups with adults seeing less adverse events with the HM3, but the same was not found (including stroke) in the pediatric cohort. Survival outcomes for patients between 10 and 25 kg were similar with the HVAD compared to the Berlin Heart EXCOR (p = 0.4290), with similarities in stroke risk., Conclusion: The removal of the HVAD device may result in a care gap in younger patient whose survival outcomes do not mirror that of older adults. The HM3 can fill a portion of this gap with good survival, but there remains a subset of pediatric patients that, based on initial HM3 use, will no longer have access to intracorporeal support and therefore, despite reasonable outcomes with the Berlin Heart EXCOR, will not be able to be discharged home. Lastly, it is essential that future changes to the availability of devices take into account the various patient populations that utilize the device to avoid unintended consequences of access inequality., (Copyright © 2023 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)
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- 2023
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43. Contemporary outcomes of pediatric cardiac transplantation with a positive retrospective crossmatch.
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Lytrivi ID, Koehl D, Esteso P, Frandsen EL, Gibbons MK, Kirklin JK, Cantor R, Lamour JM, Putschoegl A, Shugh S, Williams RJ, and Pearce FB
- Abstract
Background: A positive crossmatch (+ XM) has traditionally been associated with adverse outcomes following pediatric heart transplantation. However, more recent studies suggest that favorable intermediate-term outcomes may be achieved despite a + XM. This study's hypothesis is that children with a + XM have similar long-term survival, but higher rate of complications such as rejection, coronary allograft vasculopathy (CAV), and infection, compared to patients with a negative (-) XM., Methods: The Pediatric Heart Transplant Society Registry (PHTS) database was queried from 2010-2021 for all patients <18 years of age with a known XM. Baseline demographics were compared between + XM and - XM groups using appropriate parametric and non-parametric group comparisons. Cox Proportional Hazards Modeling was used to identify risk factors for post-transplant graft loss, rejection, and CAV., Results: Of 4599 pediatric heart transplants during the study period, XM results were available for 3914 (85%), of which 373 (9.5%) had a + XM. Univariate analysis showed lower 10-year survival for patients with + XM (HR = 1.3, p = .04). Multivariate analyses revealed no significant difference in 10-year survival in the 2 groups; however, time to first rejection (p = .0001) remained significantly shorter in the + XM group., Conclusions: Pediatric patients transplanted across a + XM experience earlier rejection; however, after multivariate adjustment, + XM is not independently associated with intermediate-term graft loss. The risk of heart transplantation against a + XM must be balanced with the ongoing risk of waitlist mortality., (© 2023 Wiley Periodicals LLC.)
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- 2023
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44. Hospital Mortality and Adverse Events Following Repair of Congenital Heart Defects in Developing Countries.
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Bateson BP, Deng L, Ange B, Austin E, Dabal R, Broser T, Pennington J, Sivakumar S, Lee C, Truong NLT, Jacobs JP, Cervantes J, Kirklin JK, and St Louis J
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- Child, Humans, Infant, Child, Preschool, Hospital Mortality, Developing Countries, Risk Factors, Heart Defects, Congenital surgery, Cardiac Surgical Procedures adverse effects
- Abstract
Background: Mortality associated with the correction of congenital heart disease has decreased to approximately 2% in developed countries and major adverse events are uncommon. Outcomes in developing countries are less well defined. The World Database for Pediatric and Congenital Heart Surgery was utilized to compare mortality and adverse events in developed and developing countries., Methods: A total of 16,040 primary procedures were identified over a two-year period. Centers that submitted procedures were dichotomized to low/middle income (LMI) and high income (HI) by the Gross National Income per capita categorization. Mortality was defined as any death following the primary procedure to discharge or 90 days inpatient. Multiple logistic regression models were utilized to identify independent predictors of mortality., Results: Of the total number of procedures analyzed, 83% (n = 13,294) were from LMI centers. Among all centers, the mean age at operation was 2.2 years, with 36% (n = 5,743) less than six months; 85% (n = 11,307) of procedures were STAT I/II for LMI centers compared with 77% (n = 2127) for HI centers ( P < .0001). Overall mortality across the cohort was 2.27%. There was a statistical difference in mortality between HI centers (0.55%) versus LMI centers (2.64%) ( P < .0001). After adjustment for other risk factors, the risk of death remained significantly higher in LMI centers (odds ratio: 2.36, 95% confidence interval: 1.707-3.27)., Conclusion: Although surgical expertise has increased across the globe, there remains a disparity with some outcomes associated with the correction of congenital heart disease between developing and developed countries. Further studies are needed to identify specific opportunities for improvement., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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- 2023
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45. The impact of obesity and LVAD-bridging on heart transplant candidate outcomes: a linked STS INTERMACS - OPTN/UNOS data analysis.
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Alba AC, Kirklin JK, Cantor RS, Deng L, Ross HJ, Jacobs JP, Rao V, Hanff TC, and Stehlik J
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- Adult, Humans, Overweight complications, Obesity complications, Obesity epidemiology, Data Analysis, Treatment Outcome, Retrospective Studies, Heart-Assist Devices, Heart Transplantation, Heart Failure complications, Heart Failure surgery
- Abstract
Background: Limited data integrating waitlist and postheart transplant (HT) mortality have evaluated outcomes of left ventricular assist device (LVAD)-bridged strategy vs no LVAD according to patient characteristics. We evaluated waitlist and post-HT mortality in LVAD-bridged vs nonbridged patients based on body mass index (BMI)., Methods: We included linked adults listed for HT in Organ Procurement and Transplant Network/United Network for Organ Sharing and patients receiving durable LVAD as bridge to HT or candidacy in Society of Thoracic Surgeons/Interagency Mechanical Circulatory Support databases (2010-2019). Using BMI at listing or LVAD implant, we categorized patients as underweight (<18.5 kg/m
2 ), normal weight (18.5-24.99 kg/m2 ), overweight (25-29.99 kg/m2 ), and obese (≥30 kg/m2 ). Kaplan-Meier analysis and multivariable Cox proportional hazards models informed the effect of LVAD-bridged and nonbridged strategy by BMI on waitlist, post-HT, and overall mortality (including waitlist and post-HT mortality)., Results: Among 11,216 LVAD-bridged and 17,122 nonbridged candidates, bridged candidates were more frequently obese (37.3% vs 28.6%) (p < 0.001). Multivariable analysis indicated increased waitlist mortality in LVAD-bridged vs nonbridged with overweight (Hazard ratio (HR) 1.18, 95% confidence interval (CI) 1.02-1.36) or obesity (HR 1.35, 95%CI 1.17-1.56) in comparison to normal weight candidates (HR 1.02, 95%CI 0.88-1.19) (p-interaction < 0.001). Post-transplant mortality was not statistically different in LVAD-bridged vs nonbridged patients across BMI categories (p-interaction = 0.26). There was a nonsignificant graded increase in overall mortality in LVAD-bridged with overweight (HR 1.53, 95%CI 1.39-1.68) or obesity (HR 1.61, 95%CI 1.46-1.78) compared to nonbridged patients (p-interaction = 0.13)., Conclusions: LVAD-bridged candidates with obesity had higher waitlist mortality compared to nonbridged candidates with obesity. Post-transplant mortality was similar in LVAD-bridged and nonbridged patients, but obesity remained associated with increased mortality in both groups. This study may aid clinicians and advanced heart failure patients with obesity in decision-making., (Copyright © 2023 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)- Published
- 2023
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46. Hybrid palliation versus nonhybrid management for a multi-institutional cohort of infants with critical left heart obstruction.
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Argo MB, Barron DJ, Bondarenko I, Eckhauser A, Gruber PJ, Lambert LM, Paramananthan T, Rahman M, Winlaw DS, Yerebakan C, Alsoufi B, DeCampli WM, Honjo O, Kirklin JK, Prospero C, Ramakrishnan K, St Louis JD, Turek JW, O'Brien JE Jr, Pizarro C, Anagnostopoulos PV, Blackstone EH, Jacobs ML, Jegatheeswaran A, Karamlou T, Stephens EH, Polimenakos AC, Haw MP, and McCrindle BW
- Abstract
Objective: To compare patient characteristics and overall survival for infants with critical left heart obstruction after hybrid palliation (bilateral pulmonary artery banding with or without ductal stenting) versus nonhybrid management (eg, Norwood, primary transplantation, biventricular repair, or transcatheter/surgical aortic valvotomy)., Methods: From 2005 to 2019, 1045 infants in the Congenital Heart Surgeons' Society critical left heart obstruction cohort underwent interventions across 28 institutions. Using a balancing score propensity analysis, 214 infants who underwent hybrid palliation and 831 infants who underwent nonhybrid management were proportionately matched regarding variables significantly associated with mortality and variables noted to significantly differ between groups. Overall survival between the 2 groups was adjusted by applying balancing scores to nonparametric estimates., Results: Compared with the nonhybrid management group, infants who underwent hybrid palliation had lower birth weight, smaller gestational age, and higher prevalence of in-utero interventions, noncardiac comorbidities, preoperative mechanical ventilation, absent interatrial communication, and moderate or severe mitral valve stenosis (all P values < .03). Unadjusted 12-year survival after hybrid palliation and nonhybrid management, was 55% versus 69%, respectively. After matching, 12-year survival after hybrid palliation versus nonhybrid management was 58% versus 63%, respectively (P = .37). Among matched infants born weighing <2.5 kg, 2-year survival after hybrid palliation versus nonhybrid management was 37% versus 51%, respectively (P = .22)., Conclusions: Infants born with critical left heart obstruction who undergo hybrid palliation have more high-risk characteristics and anatomy versus infants who undergo nonhybrid management. Nonetheless, after adjustment, there was no significant difference in 12-year survival after hybrid palliation versus nonhybrid management. Mortality remains high, and hybrid palliation confers no survival advantage, even for lower-birth-weight infants., (Copyright © 2023 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2023
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47. Survival in Pediatric Patients With Ventricular Assist Devices: A Special Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) Report.
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Ashfaq A, Lorts A, Rosenthal D, Adachi I, Rossano J, Davies R, Simpson KE, Maeda K, Wisotzkey B, Koehl D, Cantor RS, Jacobs JP, Peng D, Kirklin JK, and Morales DLS
- Abstract
Background: The Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) provides detailed understanding on pediatric patients supported with ventricular assist devices (VADs). We sought to identify important variables affecting mortality in pediatric VADs., Methods: Patients aged <19 years, from 2012 to 2021, were included. Survival analyses were performed using Kaplan-Meier. Parametric hazard modeling was used to identify risk factors for death., Results: Of the 1109 patients, the most common devices were implantable continuous (IC, 448 [40%]), followed by paracorporeal pulsatile (PP, 306 [28%]), paracorporeal continuous (PC, 293 [26%]), and percutaneous (58 [5%]). Patients with percutaneous device, infants, congenital heart disease, biventricular support, and Interagency Registry for Mechanically Assisted Circulatory Support profile 1 had worse overall survival at 6 months. Positive outcome was 83% at 6 months. Consistent with their cohort composition, device type positive outcomes at 6 months were IC, 92%; PP, 84%; and PC, 69%. Parametric hazard modeling for overall survival showed an early hazard for death with biventricular support, congenital heart disease (CHD), intubation before implantation, PC device, and renal impairment, whereas a constant hazard was associated with ascites. For patients <10 kg, parametric modeling showed an early hazard for CHD, intubation, and renal impairment. Modeling in CHD patients showed an early hazard for biventricular support, renal impairment, and use of PC/PP devices., Conclusions: This multivariable analysis of the complete Pedimacs database demonstrates that illness at VAD implantation, diagnosis, and strategy of support affect survival and differ by device type. We hope this is the first step in creating a predictive tool to help providers and families have informed expectations., (Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)
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- 2023
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48. Outcomes After Hybrid Palliation for Infants With Critical Left Heart Obstruction.
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Argo MB, Barron DJ, Eghtesady P, Yerebakan C, DeCampli WM, Alsoufi B, Honjo O, Jacobs JP, Paramananthan T, Rahman M, Lambert LM, Jegatheeswaran A, Carrillo SA, Husain SA, Ramakrishnan K, Caldarone CA, Karamlou T, Nelson J, Mannie C, Romano JC, Turek JW, Blackstone EH, Galantowicz ME, Kirklin JK, Mitchell ME, and McCrindle BW
- Subjects
- Infant, Humans, Treatment Outcome, Heart Ventricles diagnostic imaging, Heart Ventricles surgery, Heart Ventricles abnormalities, Heart Block, Palliative Care, Retrospective Studies, Hypoplastic Left Heart Syndrome surgery, Fontan Procedure, Tricuspid Valve Insufficiency
- Abstract
Background: Hybrid palliation (bilateral pulmonary artery banding with or without ductal stenting) is an initial management strategy for infants with critical left heart obstruction and serves as palliation until subsequent operations are pursued., Objectives: This study sought to determine patient characteristics and factors associated with subsequent outcomes for infants who underwent hybrid palliation., Methods: From 2005 to 2019, 214 of 1,236 prospectively enrolled infants within the Congenital Heart Surgeons' Society's critical left heart obstruction cohort underwent hybrid palliation across 24 institutions. Multivariable hazard modeling with competing risk methodology was performed to determine risk and factors associated with outcomes of biventricular repair, Fontan procedure, transplantation, or death., Results: Preoperative comorbidities (eg, prematurity, low birth weight, genetic syndrome) were identified in 70% of infants (150 of 214). Median follow-up was 7 years, ranging up to 17 years. Overall 12-year survival was 55%. At 5 years after hybrid palliation, 9% had biventricular repair, 36% had Fontan procedure, 12% had transplantation, 35% died without surgical endpoints, and 8% were alive without an endpoint. Factors associated with transplantation were absence of ductal stent, older age, absent interatrial communication, smaller aortic root size, larger tricuspid valve area z-score, and larger left ventricular volume. Factors associated with death were low birth weight, concomitant genetic syndrome, cardiopulmonary bypass use during hybrid palliation, moderate to severe tricuspid valve regurgitation, and smaller ascending aortic size., Conclusions: Mortality remains high after hybrid palliation for infants with critical left heart obstruction. Nonetheless, hybrid palliation may facilitate biventricular repair for some infants and for others may serve as stabilization for intended functional univentricular palliation or primary transplantation., Competing Interests: Funding Support and Author Disclosures The CHSS-CRQ was supported financially by CHSS members and participating institutions. Dr Argo has received funding from the CHSS John W. Kirklin/David Ashburn Fellowship, The Hospital for Sick Children Division of Cardiovascular Surgery, and The University of Wisconsin Department of Surgery. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2023
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49. PROMIS: Physical, Mental and Social Health Outcomes Improve From Before to Early After LVAD Implant: Findings From the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL) Study.
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Hahn EA, Allen LA, Lee CS, Denfeld QE, Stehlik J, Cella D, Lindenfeld J, Teuteberg JJ, McIlvennan CK, Kiernan MS, Beiser DG, Walsh MN, Adler ED, Ruo B, Kirklin JK, Klein L, Bedjeti K, Cummings PD, Burns JL, Vela AM, and Grady KL
- Subjects
- Humans, Male, Female, Middle Aged, Patient Reported Outcome Measures, Adult, Aged, Surveys and Questionnaires, Time Factors, Treatment Outcome, Follow-Up Studies, Adaptation, Psychological, Health Status, Heart-Assist Devices psychology, Quality of Life psychology, Heart Failure psychology, Heart Failure surgery, Heart Failure therapy, Mental Health
- Abstract
Study participants (n = 272) completed 12 Patient-Reported Outcomes Measurement Information System (PROMIS) physical, mental and social health measures (questionnaires) prior to implantation of a left ventricular assist device (LVAD) and again at 3 and 6 months postimplant. All but 1 PROMIS measure demonstrated significant improvement from pre-implant to 3 months; there was little change between 3 and 6 months. Because PROMIS measures were developed in the general population, patients with an LVAD, their caregivers and their clinicians can interpret the meaning of PROMIS scores in relation to the general population, helping them to monitor a return to normalcy in everyday life., Competing Interests: Disclosures CSL reports grants or contracts from NIH and QED Medical Research Foundation; JS reports grants from Natera; BR, PCORI, UCSD) and consulting fees from LAA, ACI Clinical, Amgen, Boston Scientific, Cytokinetics, and Novartis; JS reports from Medtronic; JL reports from Abbott, AstraZeneca, Alleviant, Boston Scientific, Merck, CVRx, VWave, and Edwards; EDA reports from Abiomed, Novartis, Abbott, Ionis Pharmaceuticals, Sana Biotechnology, Medtronic, Lexeo Pharmaceuticals, and Cytokinetics; KLG reports payment or honoraria from Amgen; JJT reports CareDx, Medtronic, and Paragonix; MSK reports from Medtronic; BR reports TEACH faculty development program; KLG reports AHA, payment for expert testimony (EDA: Astra Zeneca), meeting/travel support; MSK reports Abbott; KLG: ISHLT, AHA); Data Safety Monitoring Board or Advisory Board; JJT reports from CareDx, Medtronic, Abiomed, Takeda, Abbott; MSK reports Medtronic; JKK reports Carmat and Xeltis clinical trials), leadership or fiduciary role (EDA Papillon Therapeutics, ResQ Pharmaceuticals); JKK reports ISHLT Research Foundation, International Society for Heart & Lung Transplantation; KLG reports ISHLT; LAA reports being associate editor of Circulation: Heart Failure; DC reports being President-elect, PROMIS Health Organization; JKK reports being Director of the Data Center for STS-Intermacs Registry for Mechanical Circulatory Support., (Copyright © 2023 Elsevier Inc. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF
50. Impact of adverse events on health-related quality of life after left ventricular assist device implantation: An STS INTERMACS analysis.
- Author
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Kilic A, Kwon JH, Grady KL, Singletary BA, Kilic A, Everitt M, Cleveland J, Cantor RS, Blackmon S, Breathett K, McKellar S, Keebler M, Kirklin JK, and Stehlik J
- Subjects
- Humans, Quality of Life, Registries, Treatment Outcome, Heart-Assist Devices adverse effects, Heart Failure surgery, Respiratory Insufficiency, Kidney Diseases
- Abstract
Background: We sought to quantify the impact of pre- and postoperative variables on health-related quality of life (HRQOL) after left ventricular assist device (LVAD) implantation., Methods: Primary durable LVAD implants between 2012 and 2019 in the Interagency Registry for Mechanically Assisted Circulatory Support were identified. Multivariable modeling using general linear models assessed the impact of baseline characteristics and postimplant adverse events (AEs) on HRQOL as assessed by the EQ-5D visual analog scale (VAS) and the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ) at 6 months and 3 years., Results: Of 22,230 patients, 9,888 had VAS and 10,552 had KCCQ reported at 6 months, and 2,170 patients had VAS and 2,355 had KCCQ reported at 3 years postimplant. VAS improved from a mean of 38.2 ± 28.3 to 70.7 ± 22.9 at 6 months and from 40.1 ± 27.8 to 70.3 ± 23.1 at 3 years. KCCQ improved from 28.2 ± 23.9 to 64.3 ± 23.2 at 6 months and from 29.8 ± 23.7 to 63.0 ± 23.7 at 3 years. Preimplant variables, including baseline VAS, had small effect sizes on HRQOL while postimplant AEs had large negative effect sizes. Recent stroke, respiratory failure, and renal dysfunction had the largest negative effect on HRQOL at 6 months, while recent renal dysfunction, respiratory failure, and infection had the largest negative effect at 3 years., Conclusions: AEs following LVAD implantation have large negative effects on HRQOL in early and late follow-up. Understanding the impact of AEs on HRQOL may assist shared decision-making regarding LVAD eligibility. Continued efforts to reduce post-LVAD AEs are warranted to improve HRQOL in addition to survival., (Copyright © 2023 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF
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