Time in Therapeutic Range Significantly Impacts Survival and Adverse Events in Destination Therapy Patients.

The study aim was to examine the impact time in therapeutic range (TTR, International Normalized Ratio [INR] 2.0-3.0) has on survival and adverse events in patients receiving the HeartWare HVAD System in the ENDURANCE and ENDURANCE Supplemental Trials. Evaluable subjects (n = 495) had >1 INR value recorded 1-24 months postimplant and were categorized as: low TTR (10-39%), moderate TTR (40-69%), and high TTR (≥70%). Baseline characteristics, adverse events, and survival were analyzed. Low TTR patients experienced higher rates of major bleeding (1.69 vs. 0.54 events per patient year [EPPY]; p < 0.001), GI bleeding (1.22 vs. 0.38 EPPY; p < 0.001), stroke (0.47 vs. 0.17 EPPY; p < 0.001), thrombus requiring exchange (0.05 vs. 0.01 EPPY; p = 0.02), infection (1.44 vs. 0.69 EPPY; p < 0.001), and renal dysfunction (0.23 vs. 0.05 EPPY; p < 0.001) compared with high TTR. Moderate TTR had higher rates of major bleeding (0.75 vs. 0.54 EPPY; p < 0.001), thrombus requiring exchange (0.05 vs. 0.01 EPPY; p = 0.007), cardiac arrhythmia (0.32 vs. 0.24 EPPY; p = 0.04), and infection (0.90 vs. 0.69 EPPY; p = 0.001) compared with high TTR. Two year survival was greater among moderate and high versus low cohorts (Log-rank p = 0.001). The significant reduction in morbidity and mortality in destination therapy (DT) HVAD patients with well-controlled TTR (≥70%) emphasizes the importance of vigilant anticoagulation management.

Outcomes of pre- heart transplantation desensitization in a series of highly sensitized patients bridged with left ventricular assist devices.

Desensitization therapy for heart transplantation (HT) candidates can shorten transplant wait times and broaden the donor pool. Specific evidence-based recommendations on both protocols and indications are lacking. We retrospectively assessed left ventricular assist devices-bridged candidates who received pre-HT desensitization therapy. The therapeutic protocol consisted of intravenous immunoglobulin and rituximab followed by bortezomib and plasmapheresis if an insufficient response was achieved. Desensitization was attempted in 10 patients; only 7 tolerated therapy and underwent transplant. For those patients, median decrease in unacceptable calculated panel reactive antibody was 11%; there was no significant decrease for 3 patients. Post-desensitization adverse events were observed in all patients which included coagulopathy, bone marrow suppression, and infection. Median time to first infection was 16 days. One patient had clinically significant rejection and 3 patients had uptrending donor-specific antibodies. Decisions to proceed with desensitization should be individualized understanding potential risks and benefits.

A case series of patients with left ventricular assist devices and concomitant mechanical heart valves.

Mechanical heart valves left in situ at the time of left ventricular assist device (LVAD) implantation are thought to potentially increase the risk of thromboembolism. Recommendations exist to replace dysfunctional mechanical mitral valves and any mechanical aortic valves at the time of LVAD implantation. Due to potential increases in cardiopulmonary bypass time and associated comorbidities with valve replacement, leaving a functional mechanical valve in place at LVAD implantation has been suggested to be a safe option. We retrospectively reviewed all patients with prior mechanical mitral or aortic valves undergoing LVAD implantation at our center between 2012 and 2017. Echocardiograms were read by a single cardiologist to assess for mechanical valve dysfunction. We identified 15 patients. Five patients had major bleeding requiring transfusion. On follow-up, 2 patients had hemorrhagic stroke and 2 had transient ischemic attach/ischemic stroke. In addition, 2 patients had LVAD thrombosis and 2 patients had LVAD driveline malfunction. Mild mechanical valve regurgitation was identified on follow-up echocardiograms of 2 patients. Rate of complications in patients with mechanical valves undergoing LVAD implantation was comparable to that reported for the general LVAD population. Leaving a functional mechanical valve in place at the time of LVAD implantation could be a reasonable alternative to valve replacement. More data are required to further guide patient care in these individuals.

Venoarterial extracorporeal membrane oxygenation use in staged combined heart-kidney transplant.

Outside of heart and lung transplantation, only few cases have been reported describing venoarterial extracorporeal membrane oxygenation (VA-ECMO) use in solid organ transplantation. We present a case of a staged combined heart-kidney transplant in which VA-ECMO was utilized after a complicated orthotopic heart transplantation to successfully complete the subsequent renal transplantation.

Treatment of HeartMate II Short-to-Shield Patients With an Ungrounded Cable: Indications and Long-Term Outcomes.

Despite modifications and a procedure to externally replace the distal portion of the percutaneous lead, damage to the wiring insulation causing an electrical short to ground, referred to as a short to shield (STS), has become an important factor in the longevity of the HeartMate II left ventricular assist device (LVAD). Device exchange has been the suggested treatment option. The aim of this study was to evaluate the long-term clinical outcomes of patients with an STS supported on an ungrounded cable. A retrospective review of all patients (n = 479) implanted with a HeartMate II at our center between January 2008 and December 2017 was performed. Patients with a documented STS maintained on an ungrounded cable were examined. Patient characteristics, time from device implantation to STS, treatment strategies, and duration of support on an ungrounded cable were summarized. The association between support with an ungrounded cable and clinical outcomes was evaluated. A total of 53 (11% of 479) patients (83% males and 81% destination therapy) with an STS were supported on an ungrounded cable for a median duration of 195 days (range 2 days to 3.3 years). Patients were more active (New York Heart Association [NYHA] p < 0.001, 6 minute walk test [6MWT] p = 0.003) and had a trend toward increased weight gain (p = 0.055) from time of implant to STS. Duration of support before the STS was 1.9 years (range 165 days to 8.6 years). Twenty-two patients were treated directly with an ungrounded cable and 31 patients underwent an external driveline repair and still required an ungrounded cable within 2 days (range 0 days to 1.3 years). During the study period, 38 patients were maintained on an ungrounded cable: 21 patients were ongoing for 299 days (range 114 days to 2.8 years), 11 patients transplanted after 79 days (range 7-295 days), four patients died because of comorbid conditions after 1.6 years (range 141 days to 3.2 years), one patient exchanged for thrombosis after 229 days, and one patient explanted after 279 days. The other 15 patients developed a phase-to-phase electrical short after 51 days (range 2 days to 3.3 years): 14 patients underwent a successful pump exchange and one patient transplanted within 2 days. No patients died because of support with an ungrounded cable or worsening lead damage necessitating device exchange. With extended durations of support, some patients with a HeartMate II LVAD will experience device failure in the form of an STS. Select patients with an STS can be safely supported on an ungrounded cable for several years with close monitoring. This treatment approach should be considered before a device exchange.

Multicenter experience with durable biventricular assist devices.

BACKGROUND: Severe right ventricular failure necessitating a right ventricular assist device (RVAD) complicates 6% to 11% of left ventricular assist device (LVAD) implants. Patient outcomes for those receiving durable continuous-flow VADs in a biventricular configuration (i.e., BiVAD) have been reported in limited case series. METHODS: Data from United States centers with ≥ 6 BiVAD implants were collected. Characteristics and outcomes of patients receiving contemporaneous (i.e., same surgery) vs staged implantation of the HVAD as a BiVAD were compared. RESULTS: From 2011 to 2017, 46 patients received durable BiVADs and had the following characteristics: median age, 46 years (interquartile range [IQR], 19-67 years), non-ischemic cardiomyopathy (80%), bridge to transplant (83%), Interagency Registry for Mechanically Assisted Circulatory Support Profile 1 or 2 (92%), use of temporary circulatory support (37%), right atrial pressure 19 mm Hg (IQR, 14-23 mm Hg), and cardiac index of 1.6 liters/min/m2 (IQR, 1.2-2.1 liters/min/m2). Operative mortality was 33%. Equal numbers of patients received a right atrial or right ventricular implant. Contemporaneous BiVAD implantation occurred in 31 patients (67%), and compared with 15 patients (33%) with staged implants, these patients had a shorter intensive care unit length of stay of 12 days (IQR, 7-23 days) vs 42 days (IQR, 28-48 days, p = 0.035) and were more likely to be discharged from the hospital on BiVAD support (61% vs 27%, p = 0.04). RVAD thrombosis developed in 17 patients (37%). Patients with contemporaneous BiVAD implants had a 1-year survival of 74% compared with 40% in staged BiVAD patients (p = 0.11). CONCLUSIONS: Patients receiving durable BiVADs represent a critically ill patient population with severe biventricular failure who have high operative mortality and RVAD thrombosis rates. The 1-year survival for patients receiving contemporaneous BiVADs in experienced centers mirrors other contemporary durable biventricular support strategies.

The development of aortic insufficiency in continuous-flow left ventricular assist device-supported patients.

BACKGROUND: Significant aortic insufficiency (AI) after left ventricular assist device (LVAD) placement affects device performance and end-organ perfusion. This study examined the development and progression of AI after implantation of continuous-flow LVAD. METHODS: Seventy-nine patients undergoing Heart Mate II (Thoratec Corp, Pleasanton, CA) LVAD implantation for predominantly destination therapy (n = 69 [87%]) were examined. Preoperative and postoperative echocardiograms for all patients were reviewed at the intervals of 0 to 3, 3 to 6, 6 to 12, 12 to 18, and 18 to 24 months. AI was graded on an interval scale of 0, none; 0.5, trivial; 1, mild; 1.5, mild to moderate; 2, moderate; 2.5, moderate to severe; and 3, severe. Development and progression of AI were analyzed. RESULTS: The incidence of significant AI (mild or greater) was 52% (n = 41). Median time to AI development was 187 days. The median duration of VAD support was 761 days. Mild AI developed in 41 patients (52%). No severe AI developed. In the Cox regression model (hazard ratio [95% confidence interval]), aortic valve closure (2.51 [1.06 to 5.89]; p = 0.03), and age (1.04 [1.008 to 1.08]; p = 0.01) were independent predictors of AI development. There was no difference in mortality rates in the two groups (p = 0.40 by log-rank test). A mixed-model linear regression analysis showed a significant overall progression of AI over time (ß ± standard error, 0.06 ± 0.02; p = 0.006). CONCLUSIONS: AI develops over time in a significant number of Heart Mate II LVAD patients. AI is more common in patients with closed aortic valves and in the older age group. As more patients require long-term VAD support, the development of AI will need careful attention and monitoring.