Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients The ROADMAP Study 2-Year Results

OBJECTIVES The authors sought to provide the pre-specified primary endpoint of the ROADMAP (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients) trial at 2 years. BACKGROUND The ROADMAP trial was a prospective nonrandomized observational study of 200 patients (97 with a left ventricular assist device [LVAD], 103 on optimal medical management [OMM]) that showed that survival with improved functional status at 1 year was better with LVADs compared with OMM in a patient population of ambulatory New York Heart Association functional class IIIb/IV patients. METHODS The primary composite endpoint was survival on original therapy with improvement in 6-min walk distance \u3e= 75 m. RESULTS Patients receiving LVAD versus OMM had lower baseline health-related quality of life, reduced Seattle Heart Failure Model 1-year survival (78% vs. 84%; p = 0.012), and were predominantly INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profile 4 (65% vs. 34%; p \u3c 0.001) versus profiles 5 to 7. More LVAD patients met the primary endpoint at 2 years: 30% LVAD versus 12% OMM (odds ratio: 3.2 [95% confidence interval: 1.3 to 7.7]; p = 0.012). Survival as treated on original therapy at 2 years was greater for LVAD versus OMM (70 +/- 5% vs. 41 +/- 5%; p \u3c 0.001), but there was no difference in intent-to-treat survival (70 +/- 5% vs. 63 +/- 5%; p = 0.307). In the OMM arm, 23 of 103 (22%) received delayed LVADs (18 within 12 months; 5 from 12 to 24 months). LVAD adverse events declined after year 1 for bleeding (primarily gastrointestinal) and arrhythmias. CONCLUSIONS Survival on original therapy with improvement in 6-min walk distance was superior with LVAD compared with OMM at 2 years. Reduction in key adverse events beyond 1 year was observed in the LVAD group. The ROADMAP trial provides risk-benefit information to guide patient- and physician-shared decision making for elective LVAD therapy as a treatment for heart failure. (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients [ROADMAP]; NCT01452802

Donor Heart Utilization following Cardiopulmonary Arrest and Resuscitation: Influence of Donor Characteristics and Wait Times in Transplant Regions

Background. Procurement of hearts from cardiopulmonary arrest and resuscitated (CPR) donors for transplantation is suboptimal. We studied the influences of donor factors and regional wait times on CPR donor heart utilization. Methods. From UNOS database (1998 to 2012), we identified 44,744 heart donors, of which 4,964 (11%) received CPR. Based on procurement of heart for transplantation, CPR donors were divided into hearts procured (HP) and hearts not procured (HNP) groups. Logistic regression analysis was used to identify predictors of heart procurement. Results. Of the 4,964 CPR donors, 1,427 (28.8%) were in the HP group. Donor characteristics that favored heart procurement include younger age (25.5 ± 15 yrs versus 39 ± 18 yrs, P≤0.0001), male gender (34% versus 23%, P≤0.0001), shorter CPR duration (<15 min versus >30 min, P≤0.0001), and head trauma (60% versus 15%). Among the 11 UNOS regions, the highest procurement was in Region 1 (37%) and the lowest in Region 3 (24%). Regional transplant volumes and median waiting times did not influence heart procurement rates. Conclusions. Only 28.8% of CPR donor hearts were procured for transplantation. Factors favoring heart procurement include younger age, male gender, short CPR duration, and traumatic head injury. Heart procurement varied by region but not by transplant volumes or wait times

Additive Costs of Postoperative Complications for Isolated Coronary Artery Bypass.

Complications after open-heart surgery result in an increased length of stay and greater financial burdens for all. The purpose of this study was to measure the additive costs of postoperative complications for selected subgroups of patients after coronary artery bypass grafts in the Commonwealth of Virginia. A multiyear statewide data repository with clinical and billing data was used to measure outcomes for the period 2004 to 2007. The Society of Thoracic Surgeons records matched with Universal Billing (UB-04) charge data for all payers were used to estimate the additive costs of cardiac surgical outcomes using cost-to-charge ratios. Additive cost was defined as the difference between the baseline cost of an average case with no complications and one with a postoperative morbidity or mortality. Multivariate analysis was used to account for important covariates and apportion incremental costs. The baseline cost of isolated coronary artery bypass grafting (CABG) cases with no complications during the study period was $26,056. Isolated atrial fibrillation was the most frequently cited complication and had the lowest additive cost ($2,574). Additive costs for isolated CABG patients were greatest for those cases involving prolonged ventilation ($40,704), renal failure ($49,128), mediastinitis ($62,773), and operative mortality ($49,242). Additive costs can serve as an indicator for pursuing quality improvement initiatives. Our results suggest additive costs vary according to type of postoperative complication and comorbidities. Regional collaborations of multidisciplinary groups in cardiac surgery are an effective means to implement quality guidelines and drive down additive costs

Exercise Capacity in Patients with The Total Artificial Heart

There is a dearth of information regarding the functional abilities of patients with the total artificial heart (TAH). Increased utilization of the TAH and patient discharge to home with the portable unit necessitates a shift in focus to quality of life, which includes quantifying and ultimately optimizing functional capacity. To date only single patient case studies have described the exercise response of the TAH patient. Fourteen patients with the TAH underwent cardiopulmonary exercise testing (CPX) with concurrent analysis of TAH device function. All device settings remained fixed during testing. Peak oxygen consumption (VO2) [0.872 L·min (IQR = 0.828-1.100 L·min)], %-predicted peak VO2 [36% (IQR = 32-42%)], and ventilatory anaerobic threshold (VAT) [0.695 L·min (IQR = 0.542-0.845 L·min)] were markedly reduced in the TAH compared with predicted normal values. Determinants of VO2 using device-generated hemodynamics revealed a blunted cardiac output (CO) (+9% increase) and exaggerated oxygen extraction with exercise. Peak VO2 strongly correlated with resting (R=+0.548, P=0.045), VAT (R=+0.780, P=0.001), and peak exercise CO (R=+0.672, P=0.008). Patients with the TAH have significantly impaired exercise performance. The limitations to CPX performance appear to be related to limited ability of the pump to modulate output for activity and reduced oxygen carrying capacity