Kılıç, Ahmet

ABSTRACT Background and Aim This study aimed to provide updated nationwide data on outcomes in heart transplantation for amyloid cardiomyopathy (ACM) compared with other cardiomyopathy etiologies. Methods United Network for Organ Sharing data for patients over 18 who underwent heart transplant for ACM, and other cardiomyopathies including DCM, ICM, RCM, and CHD were reviewed from 2001 through 2022. The data were analyzed with a propensity score‐matched analysis comparing ACM patients with transplant for the cardiomyopathies to measure primary outcomes, including 5‐year, 10‐year, and all‐cause mortality accounting for differences at baseline. Results Of 21 457 heart transplant recipients who met eligibility criteria, there was a 100% increase in the number of heart transplants for ACM from 2010 to 2020 ( p < 0.001). The unadjusted mortality did not differ significantly among ACM, DCM, ICM, RCM, and CHD groups, and 5‐year mortality was comparable between ACM and DCM patients. ACM patients had a significantly lower incidence of postoperative stroke ( p = 0.044), and risk factors for ACM transplant mortality were identified as mechanical ventilation at the time of transplant (HR: 3.8, p = 0.023) and older donor age (HR: 1.1, p = 0.015). Conclusions The number of heart transplants for ACM has increased in recent years, and overall outcomes in these ACM transplants have been similar compared to those for other cardiomyopathies. Despite historical concerns regarding poor prognosis and amyloid recurrence, carefully screened ACM patients can benefit from heart transplantation. Further research and optimization of ACM patient eligibility criteria alongside investigation of concurrent adjunctive therapies could optimize treatment of ACM with heart transplantation.

Introduction and hypothesis: Recent data have indicated an increase in the rate of early, confirmed pump thrombosis of the HeartMate II (HMII) left ventricular assist device. Factors related to this increase were not known, but one of the hypotheses was change in clinical management over time. The PREVENT ( PREVEN tion of Heartmate II Pump T hrombosis through Clinical Management) study was designed to evaluate the impact of clinical practices developed to reduce the risk of HMII pump thrombosis. Methods: PREVENT is a prospective, multi-center, single-arm, non-randomized study of up to 300 patients at up to 25 sites. Patient and pump management, including implant technique, anticoagulation, and pump settings are guided by protocol (Table 1). Primary endpoint is incidence of confirmed pump thrombosis at 3 months, with a total follow-up of 6 months. Presented here are the preliminary results from the first 100 subjects enrolled. Results: Median age was 61 years [25-79], 87% were male, and 79% were destination therapy. At implant, 9% were in INTERMACS Profile1, 68% Profiles 2-3, and 22% Profiles 4-7. Preliminary analysis of 90-day outcomes demonstrated an incidence of 1% for confirmed and 2% for suspected thrombosis with a 38% incidence of INTERMACS-defined bleeding. Adherence to the protocol recommendations was as follows: 91% of the pumps were anchored, 97% of the patients were bridged with heparin, median pump speed at 1 month was 9190 [range: 8400-10000], with 93% of the patients having a pump speed > 8600, and 78% of the patients having pump speeds > 9000. Median INR per patient was 2.2 [IQR: 2.0-2.4]. Overall Kaplan-Meier survival was 93%. Conclusions: Preliminary results are encouraging and suggest good adherence to the PREVENT protocol and low rates of pump thrombosis without a resultant increase in bleeding complications. Overall survival after HM II implantation remains excellent.