Background:
Left ventricular assist device (LVAD) unloading and hemodynamic support in patients with advanced chronic heart failure can result in significant improvement in cardiac function allowing LVAD removal, however the rate of this is generally considered to be low. This prospective multicenter non-randomized study (RESTAGE-HF) investigated whether a protocol of optimized LVAD mechanical unloading, combined with standardized specific pharmacological therapy to induce reverse remodeling and regular testing of underlying myocardial function, could produce a higher incidence of LVAD explantation.
Methods:
Forty patients with chronic advanced heart failure from non-ischemic cardiomyopathy receiving the Heartmate II LVAD were enrolled from 6 centers. LVAD speed was optimized with an aggressive pharmacological regimen and regular echocardiograms were performed at reduced LVAD speed (6000rpm, no net flow) to test underlying myocardial function. The primary endpoint was the proportion of patients with sufficient improvement of myocardial function to reach criteria for explantation within 18 months with sustained remission from HF (freedom from transplant/VAD/death) at 12 months.
Results:
Prior to LVAD age was 35.1±10.8 years, 67.5% were male, heart failure mean duration was 20.8±20.6 months, 95% required inotropic and 20% temporary mechanical support, left ventricular ejection fraction (LVEF) was 14.5±5.3%, end-diastolic diameter (LVEDD) 7.33±0.89cm, end-systolic diameter (LVESD) 6.74±0.88cm, PA saturations were 46.7±9.2% and pulmonary capillary wedge pressure (PCWP) was 26.2±7.6mmHg. Four enrolled patients did not undergo the protocol due to medical complications unrelated to the study procedures. Overall 40% of all enrolled (16/40) patients achieved the primary endpoint, p<0.0001, with 50% (18/36) of patients receiving the protocol being explanted within 18 months (pre-explant LVEF 57±8%; LVEDD 4.81±0.58cm; LVESD 3.53±0.51cm; PCWP 8.1±3.1mmHg; PA sats 63.6±6.8% at 6000rpm). Overall 19 patients were explanted (19/36, 52.3% of those receiving the protocol). The fifteen ongoing explanted patients are now 2.26±0.97years post explant. Post-explantation survival free from LVAD or transplantation was 90% at 1-year and 77% at 2 and 3 years.
Conclusions:
In this multicenter prospective study, this strategy of LVAD support combined with a standardized pharmacologic and cardiac function monitoring protocol resulted in a high rate of LVAD explantation and was feasible and reproducible with explants occurred in all six participating sites.
BackgroundMany patients with heart failure continue cardiac resynchronization therapy (CRT) after continuous flow left ventricular assist device (CF‐LVAD) implant. We report the first multicenter study to assess the impact of CRT on clinical outcomes in CF‐LVAD patients.Methods and ResultsAnalysis was performed on 488 patients (58±13 years, 81% male) with an implantable cardioverter defibrillator (ICD) (n=223) or CRT‐D (n=265) who underwent CF‐LVAD implantation at 5 centers from 2007 to 2015. Effects of CRT on mortality, hospitalizations, and ventricular arrhythmia incidence were compared against CF‐LVAD patients with an ICD alone. Baseline differences were noted between the 2 groups in age (60±12 versus 55±14, P<0.001) and QRS duration (159±29 versus 126±34, P=0.001). Median biventricular pacing in the CRT group was 96%. During a median follow‐up of 478 days, Kaplan–Meier analysis showed no difference in survival between groups (log rank P=0.28). Multivariate Cox regression demonstrated no survival benefit with type of device (ICD versus CRT‐D; P=0.16), whereas use of amiodarone was associated with increased mortality (hazard ratio 1.77, 95% confidence interval 1.1–2.8, P=0.01). No differences were noted between CRT and ICD groups in all‐cause (P=0.06) and heart failure (P=0.9) hospitalizations, ventricular arrhythmia incidence (43% versus 39%, P=0.3), or ICD shocks (35% versus 29%, P=0.2). During follow‐up, 69 (26%) patients underwent pulse generator replacement in the CRT‐D group compared with 36 (15.5%) in the ICD group (P=0.003).ConclusionsIn this large, multicenter CF‐LVAD cohort, continued CRT was not associated with improved survival, hospitalizations, incidence of ventricular arrhythmia and ICD therapies, and was related to a significantly higher number of pulse generator changes.
Screening using a low-dose CT scan is associated with high cost, repeated radiation exposure, and low accrual. The high sensitivity, convenience, and low cost of breath analysis for carbonyl cancer markers suggests that it has the potential to become a primary screening modality for lung cancer.
Unlike the lung allocation score, currently, there is no quantitative scoring system available for patients on heart transplant waiting list. By using United Network for Organ Sharing (UNOS) data, we aim to generate a scoring system based on the recipient and donor risk factors to predict posttransplant survival. Available UNOS data were queried between 2005 and 2013 for heart transplant recipients aged ≥18 years to create separate cox-proportional hazard models for recipient and donor risk scoring. On the basis of risk scores, recipients were divided into five groups and donors into three groups. Kaplan-Meier curves were used for survival. Total 17,131 patients had heart transplant within specified time period. Major factors within high-risk groups were body mass index > 30 kg/m (46%), mean pulmonary artery pressure >30 mmHg (65%), creatinine > 1.5 mg% (63%), bilirubin > 1.5 mg% (54%), noncontinuous-flow left ventricular assist devices (45%) for recipients and gender mismatch (81%) and ischemia time >4 hours (88%) for donors. Survival in recipient groups 1, 2, 3, 4, and 5 at 5 years was 81, 80, 77, 74, and 62%, respectively, and in donor groups 1, 2, and 3 at 5 years was 79, 77, and 70%, respectively (p < 0.001). Combining donor and recipient groups based on scoring showed acceptable survival in low-risk recipients with high-risk donor (75% at 5 years). A higher recipient and donor risk score are associated with worse long-term survival. A low-risk recipient transplanted with high-risk donor has acceptable survival at 5 years, but high-risk recipient combined with a high-risk donor has marginal results. Using an objective scoring system could help get the best results when utilizing high-risk donors.
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