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Background: A multicenter clinical trial conducted from 2005 to 2008 of a continuous flow left ventricular assist device (LVAD) resulted in Food and Drug Administration approval for bridge to transplantation. The purpose of this analysis was to determine changes in posttrial outcomes in widespread commercial use since the clinical trial. Methods: We compared outcomes of 486 patients who received a continuous flow LVAD as a bridge to transplantation at 36 centers during the clinical trial (March 2005 to April 2008) with outcomes of 1,496 posttrial patients who received a continuous flow LVAD at 83 centers (April 2008 to September 2010 as reported to the Interagency Registry for Mechanically Assisted Circulatory Support). Results: Baseline data were comparable between groups. Cumulative follow-up was 511 and 1,082 patient-years for trial and posttrial patients, respectively, and average support duration was 12.6 ± 14.0 and 8.7 ± 7.1 months. Kaplan-Meier survival improved at 1 year from 76% (trial) to 85% (posttrial). The percentage of patients undergoing transplantation in the first year decreased from 48% in the trial period to 39% in the posttrial period. Quality of life metrics improved by 3 months in both groups. Conclusions: The survival rate of a large group of continuous flow LVAD patients in a real-world setting after Food and Drug Administration market approval for bridge to transplantation has improved since the clinical trial. These data show that excellent outcomes have been maintained with dissemination of new LVAD technology from a clinical trial phase to more broad based use in the period after market approval. [ABSTRACT FROM AUTHOR]

Background: Internal cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) reduce mortality, but are underutilized in routine clinical practice. The use of these devices in patients at the time of an initial evaluation at an advanced heart failure and cardiac transplantation center is unknown. Methods: We retrospectively analyzed consecutive patients who were enrolled in a database examining parameters of cardiopulmonary exercise testing in chronic heart failure (CHF) patients at the time of an initial outpatient evaluation at a tertiary care center. Rates of ICD and CRT use in eligible patients were determined. Results: Two hundred two patients had an average age of 54 ± 13 years and an average peak oxygen consumption (pVO2) of 12.5 ± 4.5 mL/kg/min. Of 97 patients eligible for an ICD only, 57% had an ICD at the time of evaluation. Sixty-four percent of ICD-eligible male patients had an ICD compared to 36% of ICD-eligible female patients (P = 0.015). Of 105 patients meeting criteria for CRT, 54% had a CRT device. There was no difference between CRT use in eligible male and female patients. Conclusions: ICDs and CRT are underutilized in patients with severe CHF at the time of evaluation at a tertiary care center despite young age, objective functional limitation, and active consideration for advanced CHF therapies. Female patients have lower rates of ICD use than male patients. (PACE 2010; 988–993) [ABSTRACT FROM AUTHOR]

Background: A shortage of donation after brain death (DBD) donors for heart transplantation (HT) persists. Recent improvements in organ procurement from donation after circulatory death (DCD) donors and promising early results of DCD-HTs from Europe and Australia have renewed interest in DCD-HT.Objectives: The current study evaluated donor and recipient characteristics, early outcomes, and potential impact of adult DCD-HT in the United States.Methods: The United Network for Organ Sharing registry was used to identify and compare adult DCD donors based on their use for HT between January 2020 and February 2021. Adult DCD-HTs with available post-HT outcomes data were compared with contemporary adult DBD-HTs during study period using Cox-regression analysis and propensity-matching.Results: Of the 3,611 adult DCD donors referred during the study period, 136 were used for HT. DCD donors used for HT were younger (median age 29 years), and most were male (90%), and blood type O (79%). On comparing DCD-HT (n = 127) and DBD-HT (n = 2,961) meeting study criteria and with available data on post-HT outcomes, there was no significant difference in 30-day or 6-month mortality, primary graft failure up to 30 days, or other outcomes including in-hospital stroke, pacemaker insertion, hemodialysis, and post-HT length of hospital stay. Results were similar in propensity matched DCD-HT and DBD-HT cohorts. The number of potential adult DCD donors referred has increased substantially (n = 871 in 2010 to n = 3,045 in 2020), and the authors estimated that widespread adoption of DCD-HT could lead to approximately 300 additional adult HTs in the United States annually.Conclusions: This preliminary analysis of adult DCD-HTs from the United States showed favorable early outcomes and suggested a potential for substantial increase in adult HT volumes with use of DCD donors. [ABSTRACT FROM AUTHOR]

Background: The MOMENTUM 3 study (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) has demonstrated that the HeartMate 3 (HM3) pump is associated with reduced strokes compared with the HeartMate II (HMII) device. We now perform a comprehensive analysis of stroke events to evaluate their longitudinal occurrence, clinical correlates, patterns, and impact on outcome across the 2-year duration of support.Methods: MOMENTUM 3 is a randomized controlled trial of the HM3 centrifugal-flow pump versus the HMII axial-flow pump in patients with advanced heart failure, regardless of the intended goal of support (bridge to transplantation or destination therapy). Baseline and postimplantation clinical correlates of stroke events were assessed with multivariable analyses. Longitudinal patterns, including device association, type of stroke (hemorrhagic versus ischemic), changing severity of impairment assessed with the modified Rankin Scale (disabling [modified Rankin Scale score >3] versus nondisabling [modified Rankin Scale score ≤3]) over time, and association with outcome, were determined.Results: In 361 patients with the intended implant (189 HM3 and 172 HMII), 65 strokes (40 ischemic strokes and 25 hemorrhagic strokes) occurred in 52 patients at a median of 131 (range, 1-733) days. No difference in stroke rate was noted between 0 and 180 days of follow-up between devices. However, stroke incidence in the long-term period (181-730 days after left ventricular assist device) was 3.3 times lower for the HM3 group (HM3: 0.04 versus HMII: 0.13 events per patient-year; odds ratio, 0.23; 95% CI, 0.08-0.63; P=0.01). Treatment with the HM3 pump was the only independent predictor of lower stroke events. We found no direct association of blood pressure or antithrombotic regimens with observed stroke rates. A stroke event significantly lowered 2-year postimplantation survival regardless of subtype or initial severity of neurological impairment compared with patients without a stroke (43±12% for hemorrhagic stroke, 57±9% for ischemic stroke, 51±11% for disabling, and 51±11% for nondisabling compared with 85±2% 2-year survival for patients without stroke).Conclusions: The HM3 pump is associated with a marked reduction in stroke rates compared with the HMII device, with benefits observed in the long-term period (>6 months). The occurrence of stroke of any type (hemorrhagic and ischemic) or of any functional severity (disabling and nondisabling) is predictive of a poor 2-year clinical outcome.Clinical Trial Registration: URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT02224755. [ABSTRACT FROM AUTHOR]

Introduction: Donation after circulatory death (DCD) donors are becoming an important source of organs for heart-transplantation (HT), but there are limited data regarding their use in multiorgan-HT., Methods: Between January 2020 and June 2023, we identified 87 adult multiorgan-HTs performed using DCD-donors [77 heart-kidney, 6 heart-lung, 4 heart-liver] and 1494 multiorgan-HTs using donation after brain death (DBD) donors (1141 heart-kidney, 165 heart-lung, 188 heart-liver) in UNOS. For heart-kidney transplantations (the most common multiorgan-HT combination from DCD-donors), we also compared donor/recipient characteristics, and early outcomes, including 6-month mortality using Kaplan-Meier (KM) and Cox hazards-ratio (Cox-HR)., Results: Use of DCD-donors for multiorgan-HTs in the United States increased from 1% in January to June 2020 to 12% in January-June 2023 (p < 0.001); but there was a wide variation across UNOS regions and center volumes. Compared to recipients of DBD heart-kidney transplantations, recipients of DCD heart-kidney transplantations were less likely to be of UNOS Status 1/2 at transplant (35.06% vs. 69.59%) and had lower inotrope use (22.08% vs. 43.30%), lower IABP use (2.60% vs. 26.29%), but higher durable CF-LVAD use (19.48% vs. 12.97%), all p < 0.01. Compared to DBD-donors, DCD-donors used for heart-kidney transplantations were younger [28(22-34) vs. 32(25-39) years, p = 0.004]. Recipients of heart-kidney transplantations from DCD-donors and DBD-donors had similar 6-month survival using both KM analysis, and unadjusted and adjusted Cox-HR models, including in propensity matched cohorts. Rates of PGF and in-hospital outcomes were also similar., Conclusions: Use of DCD-donors for multiorgan-HTs has increased rapidly in the United States and early outcomes of DCD heart-kidney transplantations are promising., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Non-ST-segment myocardial infarction (NSTEMI) occurs frequently in a growing population of patients with chronic heart failure (HF) and end-stage renal disease (ESRD) but outcomes with invasive management approaches are unknown. We sought to determine in-hospital outcomes with percutaneous coronary intervention (PCI) in comparison with medical management only. The National Inpatient Sample was used to capture hospitalizations in the United States from 2006 to 2019. Admissions for NSTEMI in patients with chronic HF and ESRD were identified by International Classification of Diseases codes. The cohort was divided into those that received PCI or medical management only. In-hospital outcomes were compared by multivariable logistic regression and propensity matching. In 27,433 hospitalizations, 8,004 patients (29%) underwent PCI, and 19,429 (71%) were managed with medications only. PCI was associated with lower adjusted odds of death during hospitalization (adjusted odds ratio 0.59, 95% confidence interval 0.52 to 0.66, p <0.01). This association remained consistent after propensity matching (adjusted odds ratio 0.56, 95% confidence interval 0.49 to 0.64, p <0.01) and was apparent across all subtypes of HF. Patients with PCI had greater duration (5, 3, to 9 vs, 5, 3 to 8 days, p <0.01) and cost of hospitalization ($107,942, 70,230 to $173,182 vs, $44,156, 24,409 to $80,810, p <0.01). In conclusion, patients with HF and ESRD admitted for NSTEMI experienced lower in-hospital mortality with PCI in comparison with medical therapy only. Invasive percutaneous revascularization may be reasonable for appropriately selected patients with HF and ESRD but randomized controlled trials are needed to determine its safety and efficacy in this high-risk population., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

The Jarvik 2000 bridge to transplant investigational device exemption study was a multicentered, prospective study of 150 UNOS status I patients implanted with the Jarvik 2000 between 2005 and 2012. During the study period, there were numerous modifications of the system that included converting from pin to cone bearings. Results were analyzed for three cohorts: total (n = 150), pin (n = 128), and cone (n = 22). Baseline demographics included age (52 ± 13), gender (79% male), size (BSA 1.98), and etiology (37% idiopathic dilated cardiomyopathy; 43% Ischemic). Seventy percent of patients were either INTERMACS 1 or 2. The primary endpoint-defined as successful transplantation or listing at 180 days (prespecified at 65%; 95% lower CI: 57%)-was successfully achieved for the total cohort (67.3%; 95% CI: 59.5%-74.3%; p = 0.006). In subgroup analysis of the more contemporary, cone-bearing group, the primary endpoint was met in 91% (95% CI: 72%-97.5%; p = 0.001). Compared with pin patients, cone-bearing patients had less hemolysis as well as decreased end-organ dysfunction. Functional and quality of life scores improved after implantation independent type of bearing. In conclusion, despite a particularly sick patient population, the Jarvik 2000 was shown to be effective in supporting the advanced HF patient., (Copyright © ASAIO 2022.)

The 13th annual report from The Society of Thoracic Surgeons (STS) Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) highlights outcomes for 27,314 patients receiving continuous-flow durable left ventricular assist devices (LVAD) during the last decade (2012-2021). In 2021, 2464 primary LVADs were implanted, representing a 23.5% reduction in the annual volume compared with peak implantation in 2019 and an ongoing trend from the prior year. This decline is likely a reflection of the untoward effects of the coronavirus disease 2019 pandemic and the change in the United States heart transplant allocation system in 2018. The last several years have been characterized by a shift in device indication and type, with 81.1% of patients now implanted as destination therapy and 92.7% receiving an LVAD with full magnetic levitation in 2021. However, despite an older, more ill population being increasingly supported preimplant with temporary circulatory devices in the recent (2017-2021) vs prior (2012-2016) eras, the 1- and 5-year survival continues to improve, at 83.0% and 51.9%, respectively. The adverse events profile has also improved, with a significant reduction in stroke, gastrointestinal bleeding, and hospital readmissions. Finally, we examined the impact of the change in the heart transplant allocation system in 2018 on LVAD candidacy, implant strategy, and outcomes. In the competing-outcomes analysis, the proportion of transplant-eligible patients receiving a transplant has declined from 56.5% to 46.0% at 3 years, whereas the proportion remaining alive with ongoing support has improved from 24.1% to 38.1% at 3 years, underscoring the durability of the currently available technology., (Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The safety and effectiveness of oral anticoagulation (OAC) after an ischemic stroke in older patients with heart failure (HF) without atrial fibrillation remains uncertain., Methods: Utilizing Get With The Guidelines Stroke national clinical registry data linked to Medicare claims from 2009-2014, we assessed the outcomes of eligible patients with a history of HF who were initiated on OAC during a hospitalization for an acute ischemic stroke. The cumulative incidences of adverse events were calculated using Kaplan-Meier curves and adjusted Cox proportional hazard ratios were compared between patients discharged on or off OAC., Results: A total of 8,261 patients from 1,370 sites were discharged alive after an acute ischemic stroke and met eligibility criteria. Of those, 747 (9.0%) were initiated on OAC.  Patients on OAC were younger (77.2±8.0 vs. 80.5±8.9 years, p<0.01). After adjustment for clinical covariates, the likelihood of 1 year mortality was higher in those on OAC (aHR: 1.22, 95% CI 1.05-1.41, p<0.01), while no significant differences were noted for ICH (aHR: 1.34, 95% CI 0.69-2.59, p=0.38) and recurrent ischemic stroke (aHR: 0.78, 95% CI 0.54-1.15, p = 0.21).  The likelihood of all-cause bleeding (aHR: 1.59, 95% CI 1.29-1.96, p<0.01) and all-cause re-hospitalization (aHR: 1.14, 95% CI 1.02-1.27, p = 0.02) was higher for those on OAC., Conclusion: Initiation of OAC after an ischemic stroke in older patients with HF in the absence of atrial fibrillation is associated with death, bleeding and re-hospitalization without an associated reduction in recurrent ischemic stroke. If validated, these findings raise caution for prescribing OAC to such patients., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: One of the goals of the revised 6-tiered US adult heart allocation policy was to improve risk stratification of patients to lower exception status utilization for transplant listing. We sought to define the characteristics and outcomes of waitlisted patients using exception status and to examine region- and center-level differences in utilization of exception status in the new heart allocation system., Methods: This retrospective cohort analysis of the United Network for Organ Sharing database included adult waitlisted patients for heart transplant between October 18, 2018, and June 30, 2020, in the United States, stratified by use of exception status versus standard criteria., Results: Out of 6351 patients, 1907 (30.0%) were waitlisted under exception status. Patients using exception status were more likely to have a nonischemic cause of heart failure, blood type O, United Network for Organ Sharing status 2 at listing and were less likely to have a durable left ventricular assist device at listing. Exception status utilization varied significantly between and within United Network for Organ Sharing regions. Listing by exception criteria was associated with a significantly higher incidence of heart transplantation compared with listing by standard criteria (hazard ratio, 1.25 [1.15-1.38], P <0.001), without increased risk of death or delisting for worsening clinical status (hazard ratio, 0.83 [0.65-1.05], P =0.12) after multivariable adjustment., Conclusions: The status tiers of the new heart allocation system may not fully capture medical urgency and complexity of waitlisted patients as assessed by transplant physicians and review committees and may limit the ability to develop a heart allocation score.

Background: Patients with heart failure (HF) often have multiple chronic conditions that may impact health-related quality of life (HRQOL) despite HF therapy. We sought to determine the association between noncardiac comorbidities and HRQOL in ambulatory patients with advanced HF., Methods: Baseline data from 373 subjects in REVIVAL (Registry Evaluation of Vital Information for Ventricular Assist Devices in Ambulatory Life) were analyzed using multivariable general linear models to evaluate the relationship between comorbidities and HRQOL (EuroQol Visual Analogue Scale, EQ-5D-3L Index Score, and Kansas City Cardiomyopathy Questionnaire). The primary independent variables were a comorbidity index (sum of 14 noncardiac conditions), a residual comorbidity index (without depression), and depression alone. The median (25th to 75th percentile) number of comorbidities was 3 (2-4)., Results: Increasing comorbidity burden was associated with a reduction in generic (EQ-5D Index, P =0.005) and HF-specific (Kansas City Cardiomyopathy Questionnaire, P =0.001) HRQOL. The residual comorbidity index was not associated with HRQOL when depression included in the model independently, while depression was associated with HRQOL across all measures. Participants with depression (versus without) scored on average 13 points (95% CI, 8-17) lower on the EuroQol Visual Analogue Scale, 0.15 points (95% CI, 0.12-0.18) lower on the EQ-5D Index, and 24.9 points (95% CI, 21.2-28.5) lower on the Kansas City Cardiomyopathy Questionnaire overall summary score., Conclusions: While noncardiac comorbidities were prevalent in ambulatory advanced HF patients, only depression was associated with decreased generic and HF-specific HRQOL. Other than depression, the presence of noncardiac comorbidities should not impact expected gains in HRQOL following ventricular assist device implantation, provided the conditions are not a contraindication to implant. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01369407.

Aim: Preoperatively elevated pulmonary vascular resistance (PVR) is a contraindication to heart transplantation (HT). Transpulmonary pressure gradient (TPG) is one of the main variables used in PVR determination (ie, PVR = TPG/cardiac output). Unlike PVR, which is subject to the shortcoming of cardiac output estimation, TPG is directly measured. We aimed to evaluate the relationship of TPG obtained before left ventricular assist device (LVAD) implantation on post-HT survival., Methods and Results: A total of 490 patients were implanted with Heartmate II LVADs in the multicenter Heartmate II Bridge-to-Transplantation clinical trial, and 416/490 had pre-LVAD TPG data available. Outcomes during LVAD support and after HT stratified by both PVR and TPG were studied. The median pre-LVAD TPG was 10 mm Hg. Baseline demographic and clinical characteristics were similar for patients with and without TPG >10 mm Hg. Outcomes during LVAD support (ie, recovery to LVAD explantation, HT, or ongoing device support) for patients below and above the median TPG were similar. However, post-HT 1-year survival rate was significantly higher for patients with TPG ≤10 mm Hg compared with those with TPG >10 mm Hg (91% vs 80%; P = .016). Analysis based on the median PVR of 2.68 Wood units did not stratify post-HTx 1-year survival rates between the groups (89% vs 83%; P = .25)., Conclusions: Elevated TPG, rather than high PVR, before LVAD implantation was associated with increased mortality following HT. Pre-LVAD TPG may be useful to identify a cohort that requires close follow-up with serial hemodynamic monitoring before HT., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Peripartum cardiomyopathy (PPCM) is a pregnancy-associated cause of heart failure. Given the significant impact of heart failure on healthcare, we sought to identify etiologies and predictive factors for readmission in PPCM. We queried the 2013 to 2014 National Readmissions Database to identify patients admitted with a diagnosis of PPCM. Patients who were readmitted within 30 days were evaluated to identify etiologies and predictors of readmission. We identified 6,977 index admissions with PPCM. Of the 6,880 (98.6%) patients who survived the index hospitalization, 30-day readmission rate was 13%. Seventy-six percent of readmitted patients were admitted once, and the other 24% were readmitted at least twice within 30 days of discharge. Length of stay was ≥8 days (adjusted odds ratio [aOR] 2.80, 95% confidence interval [CI] 2.08 to 3.77), multiparity (aOR 2.07, 95% CI 1.09 to 3.92), coronary artery disease (aOR 2.28, 95% CI 1.42 to 3.67), and long-term anticoagulation use (aOR 2.51, 95% CI 1.73 to 3.64) were independently associated with increased risk of 30-day readmission. Among the readmissions, 48% were due to cardiac causes, where PPCM and related complications (24%) were the most common cardiac cause followed by heart failure (16%). The annual cost of stay for index admissions was $64.2 million (average cost for index admission was $16,892). The annual charges attributed to readmission within 30 days were ≈$9 million. Cardiac etiologies were the most common cause for 30-day readmissions in PPCM patients, with a readmission rate of 13%. Long-term anticoagulation use, multiparity, coronary disease and length of stay predicted higher 30-day readmission., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Recent trends on outcomes in cardiogenic shock (CS) complicating acute myocardial infarction (AMI) suggest improvements in early survival. However, with the ever-changing landscape in management of CS, we sought to identify age-based trends in these outcomes and mechanical circulatory support (MCS) use among patients with both AMI and non-AMI associated shock., Methods: We queried the 2005-2014 Nationwide Inpatient Sample databases to identify patients with a diagnosis of cardiogenic shock. Trends in the incidence of hospital-mortality, and use of MCS such as intra-aortic balloon pump (IABP), Impella/TandemHeart (IMP), and extra corporeal membrane oxygenation (ECMO) were analyzed within the overall population and among different age-categories (50 and under, 51-65, 66-80 and 81-99 years). We also made comparisons between patient groups admitted with CS complicating AMI and those with non-AMI associated CS., Results: We studied 144,254 cases of CS, of which 55.4% cases were associated with an AMI. Between 2005 and 2014, an overall decline in IABP use (29.8-17.7%; ptrend < 0.01), and an uptrend in IMP use (0.1-2.6%; ptrend < 0.01), ECMO use (0.3-1.8%; ptrend < 0.01) and in-hospital mortality (44.1-52.5% AMI related, 49.6-53.5% non-AMI related; ptrend < 0.01) was seen. Patients aged 81-99 years had the lowest rate of MCS use (14.8%), whereas those aged 51-65 years had highest rate of MCS use (32.3%). Multivariable analysis revealed that patients aged 51-65 years (aOR 1.46, 95% CI 1.40-1.52; p<0.001), 66-80 years (aOR 2.51, 95% CI 2.39-2.63; p<0.01) and 81-99 years (aOR 5.04, 95% CI 4.78-5.32; p<0.01) had significantly higher hospital mortality compared to patients aged ≤ 50 years. Patients admitted with CS complicating AMI were older and had more comorbidities, but lower hospital mortality (45.0 vs. 48.2%; p < 0.001) when compared to non-AMI related CS. We also noted that the proportion of patients admitted with CS complicating AMI significantly decreased from 2005 to 2014 (65.3-45.6%; ptrend < 0.01) whereas those admitted without an associated AMI increased., Conclusions: IABP use has declined whereas IMP and ECMO use has increased over time among CS admissions. Older age was associated with an incrementally higher independent risk for hospital mortality. Recent trends indicate an increase in both proportion of patients admitted with CS without associated AMI and in-hospital mortality across all CS admissions irrespective of AMI status.

Background: Early readmissions contribute significantly to heart failure-related morbidity and negatively affect quality of life. Data on left ventricular assist device (LVAD)-related 30-day readmissions are scarce and limited to small studies., Methods and Results: Patients undergoing LVAD implantation between January 2013 and November 2014 who survived the index hospitalization were identified in the Nationwide Readmissions Database. We analyzed the incidence, predictors, causes, and costs of 30-day readmissions. Of 2510 LVAD recipients, 788 (31%) were readmitted within 30 days. Length of index hospitalization ≥31 days (hazard ratio [HR], 1.26; 95% confidence interval [CI], 1.07-1.50) and female sex (HR, 1.19; 95% CI, 1.01-1.42) were associated with a higher risk of 30-day readmission, whereas private insurance (HR, 0.83; 95% CI, 0.70-0.99), pre-LVAD use of short-term mechanical circulatory support (HR, 0.53; 95% CI, 0.29-0.98), and discharge to a short-term hospital facility (HR, 0.41; CI, 0.21-0.78) were associated with a lower risk. Cardiac causes accounted for 23.8% of readmissions: heart failure (13.4%) and arrhythmias (8.1%). Noncardiovascular causes accounted for 76.2% of readmissions: infection (30.2%), bleeding (17.6%), and device-related causes (8.2%). Mean length of stay for readmission was 10.7 days (median, 6 days), and average hospital cost per readmission was $34 948±2457., Conclusions: Early readmissions are frequent after LVAD implantation even in contemporary times. Preimplant identification of high-risk patients, and a protocol-driven follow-up using a multidisciplinary approach will be needed to reduce readmissions and improve outcomes., (© 2018 American Heart Association, Inc.)

Objectives: A post-approval (PA) study for destination therapy (DT) was required by the Food and Drug Administration (FDA) to determine whether results with the HeartMate (HM) II (Thoratec, Pleasanton, California) left ventricular assist device (LVAD) in a commercial setting were comparable to results during the DT multicenter pivotal clinical trial., Background: New device technology developed in the clinical research setting requires validation in a real-world setting., Methods: The PA study was a prospective evaluation of the first 247 HM II patients identified pre-operatively as eligible for DT in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) registry. Patients were enrolled from January to September 2010 at 61 U.S. centers and followed for 2 years. A historical comparison group included patients (n = 133 at 34 centers) enrolled in the primary data cohort in the DT pivotal trial (TR). Survival rates and adverse events for the PA group were obtained from the INTERMACS registry., Results: Baseline characteristics were similar for PA versus TR. Forty-five percent of PA patients were in INTERMACS profiles 1 to 2 and 28% were in profile 3. Adverse events in the PA group were similar or lower than those in the TR group, including improvements in device-related infection (0.22 vs. 0.47) and post-operative bleeding requiring surgery (0.09 vs. 0.23) events per patient-year. Kaplan-Meier survival at 2 years was 62% (PA group) versus 58% (TR group). PA group survival at 1 and 2 years was 82 ± 5% and 69 ± 6% for INTERMACS profiles 4 to 7 (n = 63) versus 72 ± 3% and 60 ± 4% for profiles 1 to 3 (n = 184). The median length of stay after surgery was reduced by 6 days in the PA group versus the TR group., Conclusions: Results in a commercial patient care setting for the DT population supported the original pivotal clinical trial findings regarding the efficacy and risk profile of the HM II LVAD. Survival was best in patients who were not inotrope-dependent (INTERMACS profiles 4 to 7)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Aortic insufficiency (AI) is increasingly recognized as a complication of continuous flow left ventricular assist device support; however, its long-term prevalence, clinical significance, and efficacy of potential interventions are not well known., Methods and Results: We studied the prevalence and management of AI in 232 patients with continuous flow left ventricular assist device at our institution. Patients with aortic valve (AV) surgery before left ventricular assist device implantation were excluded from analysis. To examine the prevalence of de novo AI, patients without preoperative AI were divided into a retrospective and a prospective cohort based on whether a dedicated speed optimization study had been performed at the time of discharge. Forty-three patients underwent AV repair at the time of implant, and 3 subsequently developed greater than mild AI. In patients without surgical AV manipulation and no AI at the time of implant, Kaplan-Meier analysis revealed that freedom from greater than mild de novo AI at 1 year was 77.6±4.2%, and that at least moderate AI is expected to develop in 37.6±13.3% after 3 years. Nonopening of the AV was strongly associated with de novo AI development in patients without prospective discharge speed optimization. Seven of 21 patients with at least moderate AI developed symptomatic heart failure requiring surgical intervention., Conclusions: AI is common in patients with continuous flow left ventricular assist devices and may lead to clinical decompensation requiring surgical correction. The prevalence of AI is substantially less in patients whose AV opens, and optimized loading conditions may reduce AI prevalence in those patients in whom AV opening cannot be achieved.