Heart transplantation versus continuous-flow left ventricular assist device: comprehensive cost at 1 year.

BACKGROUND: With health care reform firmly on the horizon, it is critical to understand the costs associated with new technologies such as continuous-flow left ventricular assist device (CF-LVAD) compared with well established treatments such as heart transplantation (HT). Scarce data exist describing the costs of these 2 therapies after 1 year of support. METHODS AND RESULTS: The study population consisted of 20 consecutive subjects who underwent implantation of a CF-LVAD and 20 consecutive subjects who underwent HT and survived ≥1 year. Comprehensive cost calculation included all direct and indirect costs from day of operation through 365 days and were inflation adjusted to 2010 US dollars. Hospital charges were converted to costs with the use of hospital-specific cost-to-charge ratios and were analyzed by time segment as well as cost center. The total 1-year cost was higher in the CF-LVAD group, although this difference did not reach statistical significance ($369,519 [interquartile range [IQR] $321,020-$520,395] vs $329,648 [IQR $278,924-$395,456]; P = .242). In both groups, the index admission constituted >50% of the total 1-year cost and the major drivers of expense by cost center were organ/device acquisition, room and board, and professional fees. CONCLUSIONS: Patients surviving to 1 year on CF-LVAD support accrued costs similar to those of HT recipients; however, the total cost, at more than one-third of a million dollars, remains high. Reduction in the postoperative length of stay offers an avenue for significant cost savings.

Antiplatelet Therapy and Adverse Hematologic Events During Heart Mate II Support.

BACKGROUND: Hematologic adverse events are common during continuous flow left ventricular assist device support; yet, their relation to antiplatelet therapy, including aspirin (ASA) dosing, is uncertain. METHODS AND RESULTS: A single-center retrospective review of all patients supported by a continuous flow left ventricular assist device (Heart Mate II) from June 2006 to November 2014 was conducted. Patients were categorized into 3 groups: (1) ASA 81 mg+dipyridamole 75 mg daily (n = 26) with a target international normalized ratio (INR) of 2 to 3 from June 2006 to August 2009; (2) ASA 81 mg daily (n = 18) from September 2009 to August 2011 with a target INR of 1.5 to 2; and (3) ASA 325 mg daily from September 2011 to November 2014 with a target INR of 2 to 3 (n = 70). Hemorrhagic and thrombotic outcomes were retrieved ≤ 365 days after implantation. Cumulative survival free from adverse events was calculated using Kaplan-Meier curves and Cox proportional hazard ratios were generated. Hemorrhagic events occurred in 6 patients on ASA 81 mg+dipyridamole (26%; 0.42 events per patient year; mean INR at event, 2.2), 4 patients on ASA 81 mg (22%; 0.38 events per patient year; mean INR at event, 2.0), and in 38 patients on ASA 325 mg (54%; 1.4 events per patient year; mean INR at event, 2.2); P = 0.004. Patients on ASA 325 mg had a higher adjusted hazard ratio of 2.9 (95% confidence interval, 1.2-7.0 versus ASA 81 mg+dipyridamole; P = 0.02) and 3.4 (95% confidence interval, 1.2-9.5 versus ASA 81 mg; P = 0.02) for hemorrhagic events. Thrombotic events rates were not different between groups. CONCLUSIONS: High-dose ASA in Heart Mate II patients treated concomitantly with warfarin is associated with an increased hazard of bleeding but does not reduce thrombotic events.

Watchful Waiting in Continuous-Flow Left Ventricular Assist Device Patients With Ongoing Hemolysis Is Associated With an Increased Risk for Cerebrovascular Accident or Death.

BACKGROUND: Management of hemolysis in the setting of suspected device thrombosis in continuous-flow left ventricular assist device patients varies widely, ranging from watchful waiting with intensified antithrombotic therapy to early surgical device exchange. The aim of this study was to compare the outcomes of hemolysis events treated with surgical interventions versus medical management alone. METHODS AND RESULTS: A retrospective review of Heartmate II continuous-flow left ventricular assist device patients at 2 centers from January 2009 to September 2014 was completed. Patients were categorized as surgical management if hemolysis refractory to intensification of standard antithrombotic therapy was treated surgically. The primary end point was the first occurrence of cerebrovascular accident (CVA) or death. Sixty-four hemolysis events occurred in 49/367 patients implanted with Heartmate II continuous-flow left ventricular assist devices. Of 49 primary hemolysis events, 24 were treated with surgical interventions. After surgical treatment, 1 patient died and 2 experienced CVAs, as compared with 3 deaths and 9 CVAs in the 25 patients who remained on intensified antithrombotic therapy alone. The 1-year freedom from CVA or death was 87.5% and 49.5% in the surgical and medical cohorts, respectively (P=0.027). Resolution of a primary hemolysis event without CVA or death occurred in 21/24 patients treated with surgical interventions and in 13/25 who remained on medical therapy alone. A similar association between treatment and outcome was noted in the 15 recurrent hemolysis events. CONCLUSIONS: Hemolysis refractory to intensification of antithrombotic therapy identifies continuous-flow left ventricular assist device patients at major risk for CVA and death. Early device exchange should be considered to minimize these risks.