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Background: The LATERAL trial validated the safety and efficacy of the thoracotomy approach for implantation of the HeartWare HVAD System, leading to Food and Drug Administration approval. We sought to analyze 24-month adverse event (AE) rates, including a temporal analysis of the risk profile, associated with the thoracotomy approach for the HVAD system., Methods: AEs from the LATERAL trial were evaluated over 2 years postimplant. Data was obtained from the Interagency Registry for Mechanically Assisted Circulatory Support database for 144 enrolled United States and Canadian patients. Temporal AE profiles were expressed as events per patient year., Results: During 162.5 patient years of support, there were 25 driveline infections (0.15 events per patient year), 50 gastrointestinal bleeds (0.31 events per patient year), and 21 strokes (0.13 events per patient year). Longitudinal AE analysis at follow-up intervals of <30 and 30 to 180 days, and 6 to 12 and 12 to 24 months revealed the highest AE rate at <30 days, with a decrease in total AEs within the first 6 months. After 6 months, most AE rates either stabilized or decreased through 2 years, including a 95% overall freedom from disabling stroke., Conclusions: Two-year follow-up of the LATERAL trial revealed a favorable morbidity profile in patients supported with the HVAD system, as AE rates were more likely to occur in the first 30 days postimplant, and overall AE rates were significantly reduced after 6 months. Importantly, 2-year freedom from disabling stroke was 95%. These data further support the improving AE profile of patients on long-term HVAD support. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02268942.

Background: Severe symptomatic aortic stenosis (AS) is associated with high mortality without intervention. The impact of waiting time for aortic valve replacement (AVR), either surgically or transcatheter, has not been reported., Methods: From January 2008 to December 2012, we identified 1,005 patients with severe symptomatic AS. AVR was recommended for 823 patients (82%). Of these 823 patients, 721 (87.6%) underwent AVR. We modeled overall survival (OS) since AVR recommendation or intervention date using Cox and multistate models., Results: Overall, the median (first, third quartiles) waiting time until operation was 2.9 (1.3, 5.1) weeks. Mortality at these times was lower (p<0.001) in the AVR group (1.2%, 0.3%, 1.7%, respectively) than in the group that did not receive AVR (6.9%, 2.9%, 9.8%, respectively). Thirty-day mortality after AVR was 3.9% (3.2% surgical AVR [SAVR] and 7.0% transcatheter AVR [TAVR]). In patients receiving AVR, waiting time was not associated with increased mortality. Mortality while waiting for AVR was 3.7% and 11.6% at 1 and 6 months, respectively. Mortality while waiting for TAVR was higher than that for SAVR (1-, 6-, and 12-month mortality of 3.7%, 8.0%, and 9.6%, respectively, in SAVR group and 3.8%, 23.3%, and 27.5%, respectively, in TAVR group; p<0.001)., Conclusions: Some patients do not receive AVR in a timely fashion, and prolonged waiting time for AVR is associated with mortality greater than the AVR operative mortality. Although waiting time was not associated with poor operative outcomes after AVR, many patients may die while waiting for AVR. Patients should receive AVR on a semiurgent, not elective, basis., (Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Heart transplantation requires substantial personal, financial, and psychosocial resources. Using an existing multisite data set, we examined predictors of mortality at 5 to 10 years after heart transplantation., Methods: All 555 participants completed a self-report quality of life instrument. Of these patients, 55 (10%) died 5 to 10 years after heart transplantation. Statistical analyses included frequencies, means, Pearson correlation coefficients, and Cox proportional hazard modeling., Results: Educational level and higher levels of social and economic satisfaction were predictive of improved survival. Conversely, married status, more cumulative infections, the presence of hematologic disorders, higher New York Heart Association (NYHA) class, and poor adherence to medical care predicted worse survival., Conclusions: Demographic, clinical, psychosocial, and behavioral factors were important predictors of long-term survival after heart transplantation. These findings have important implications for patient selection for heart transplantation, as well as for posttransplantation care., (Copyright © 2013 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to determine whether results with the HeartMate (HM) II left ventricular assist device (LVAD) (Thoratec Corporation, Pleasanton, California) in a commercial setting are comparable to other available devices for the same indication., Background: After a multicenter pivotal clinical trial conducted from 2005 to 2008, the U.S. Food and Drug Administration approved the HM II LVAD for bridge to transplantation (BTT). A post-approval study was required by the U.S. Food and Drug Administration to determine whether results with the device in a commercial setting are comparable to other available devices for the same indication., Methods: The study was a prospective evaluation of the first 169 consecutive HM II patients enrolled in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) who were listed for transplant or likely to be listed. Patients were enrolled from April through August 2008 at 77 U.S. centers and followed for at least 1 year after implant. A comparison group (COMP) included all patients (n = 169 at 27 centers) enrolled in the INTERMACS registry with other types of LVADs (79% HeartMate XVE, 21% Implantable Ventricular Assist Device [Thoratec Corporation]) for the same BTT indication in the same time period. Survival rates, adverse events, and quality of life with the EuroQol EQ-5D visual analog scale were obtained in the INTERMACS registry., Results: Baseline characteristics were similar, but creatinine and blood urea nitrogen were lower in the HM II versus COMP groups, and there were fewer patients in the highest-risk INTERMACS patient profile Number 1 (24% for HM II vs. 39% for COMP). Adverse event rates were similar or lower for HM II versus COMP for all events. Bleeding was the most frequent adverse event for both groups (1.44 vs. 1.79 events/patient-year). Operative 30-day mortality for HM II was 4% versus 11% for COMP. The percentage of patients reaching transplant, cardiac recovery, or ongoing LVAD support by 6 months was 91% for HM II and 80% for COMP, and the Kaplan-Meier survival for patients remaining on support at 1 year was 85% for HM II versus 70% for COMP. Quality of life was significantly improved at 3 months of support and sustained through 12 months in both groups compared with baseline., Conclusions: The results in a post-market approval, actual patient care setting BTT population support the original findings from the pivotal clinical trial regarding the efficacy and risk profile of the HM II LVAD. These data suggest that dissemination of this technology after approval has been associated with continued excellent results., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Our study compared health-related quality of life (HRQOL) among cardiac surgical patient groups before and after cardiac operations for isolated surgical procedures and examined cardiac surgical patient HRQOL within the context of United States population norms., Methods: Of 2524 patients undergoing cardiac operations, 370 underwent isolated procedures (coronary artery bypass grafting, 136; aortic valve repair or replacement, 96; mitral valve repair or replacement, 92; Maze procedures, 46) between April 18, 2004, and June 30, 2008. They completed Short Form 36 questionnaires at baseline, at 3, 6, and 12 months postoperatively, and annually thereafter. Statistical analyses included χ(2), analysis of variance, longitudinal modeling, and longitudinal multivariable analyses., Results: Overall, the 370 cardiac surgical patients were 61.5 ± 11.9 years old, 70% men, and 76% white. Significant baseline differences in HRQOL existed among the cardiac surgical groups. Physical and mental components of the Short Form 36 improved from baseline to within 3 to 6 months postoperatively and remained stable through 3 years for all groups. When demographic and clinical covariates were held constant, the effect of cardiac surgical type on postsurgical HRQOL changes was not significant., Conclusions: HRQOL improves early after cardiac operations and remains relatively constant long-term, independently of procedure type., (Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)