Faculty Bibliography

A total artificial heart (TAH) is the sole remaining option for patients with biventricular failure who cannot be rescued by left ventricular assist devices (LVADs) alone. However, the pulsatile TAH in clinical use today has limitations: large pump size, unknown durability, required complex anticoagulation regimen, and association with significant postsurgical complications. That pump is noisy; its large pneumatic driving lines traverse the body, with bulky external components for its drivers. Continuous-flow pumps, which caused a paradigm shift in the LVAD field, have already contributed to the rapidly evolving development of TAHs. Novel continuous-flow TAHs are only in preclinical testing or developmental stages. We here review the current state of TAHs, with recommended requirements for the TAH of the future.

There is insufficient data on patients with small body size to determine if this should be considered a risk factor for continuous-flow left ventricular assist device (CF-LVAD) support. We sought to evaluate survival outcomes, adverse events, and functional status of CF-LVAD patients with body surface area (BSA) <1.5 m in a large national registry. Adults with BSA < 1.5 m (n = 128) implanted with a HeartMate II (HMII)-LVAD from the Interagency Registry for Mechanically Assisted Circulatory Support registry from April 2008 to December 2012 formed this cohort. Outcomes were compared with HMII bridge to transplant (BTT) and destination therapy (DT) post approval studies. The majority of patients were female (n = 106, 83%). A total of 64% (n = 82) were implanted for BTT and 36% (n = 46) for DT. The median BSA (range) was 1.44 (1.19-1.49) and 1.45 (1.25-1.49) m for BTT and DT, respectively. Overall survival 1 year post implant was 81% +/- 5% for BTT and 84% +/- 6% for DT. The most common adverse events for BTT and DT patients were bleeding (0.91, 0.88 events/patient year) and driveline infection (16%, 0.28 events/patient year). Six months post implantation, 87% of BTT and 77% of DT patients were New York Heart Association functional class I or II. Post implant survival, functional status improvement, and adverse event profile for adult BTT and DT HMII patients with BSA < 1.5 m are favorable and comparable with outcomes published in the overall patient population.

Appropriate early anticoagulation after left ventricular assist device (LVAD) implantation has not been established with practices ranging from no anticoagulation to early heparinization. The goal of this study was to evaluate the efficacy and morbidity of three strategies before initiating oral anticoagulation therapy. This was a noninterventional, retrospective, matched historical control cohort study. The primary and secondary endpoints were thrombotic complications (TCs) and bleeding up to 30 days post-LVAD implantation. There was a significant difference in the overall rate of TCs between strategies (p = 0.017). The incidence of TCs was significantly lower in the heparin group versus no bridging (4.9 vs. 27.0%, p = 0.008) on univariate analysis. On multivariate analysis, heparin was independently associated with a lower odds of TCs (odds ratio [OR], 0.10; 95% confidence interval [CI], 0.01-0.85). No differences were observed in bleeding between groups (p = 0.127) on univariate analysis; however, heparin was independently associated with increased odds of bleeding compared with no bridging on multivariate analysis (OR, 2.93; 95% CI, 1.15-7.43). Compared with no bridging, bivalirudin did not significantly differ in TC or bleeding events. Heparin seems to be the most effective regimen to use post-LVAD implantation but may increase the patient's risk for bleeding.

End-stage heart failure affects thousands of children yearly and mechanical circulatory support is used at many points in their care. Extracorporeal membrane oxygenation supports both the failing heart and lungs, which has led to its use as an adjunct to cardiopulmonary resuscitation as well as in post-operative cardiogenic shock. Continuous-flow ventricular assist devices (VAD) have replaced pulsatile-flow devices in adults and early studies have shown promising results in children. The Berlin paracorporeal pulsatile VAD recently gained U.S. Food and Drug Administration approval and remains the only VAD approved in pediatrics. Failing univentricular hearts and other congenitally corrected lesions are new areas for mechanical support. Finding novel uses, improving durability, and minimizing complications are areas of growth in pediatric mechanical circulatory support.

BACKGROUND: We recently reported using bench testing that the Thoratec HeartMate II at 6,000 rpm contributed to hemodynamics when the heart had not recovered well, making weaning assessment questionable. In this bench study, we characterized hemodynamics and pump flow of the HeartWare HVAD at 1,800 rpm, the lowest speed commonly used to assess clinical recovery. METHODS: The HVAD was operated in a mock loop at 1,800, 2,400, and 3,000 rpm. We acquired pressure-flow curves in each steady state. In pulsatile mode with the pneumatic ventricle (heart simulator) activated, pump flow, total flow, and aortic pressure (AoP) data were obtained under conditions simulating normal heart function or heart failure. RESULTS: A large regurgitant flow during diastole was confirmed during normal heart function at 1,800 rpm support; however, the net flow was zero, and there was no difference in mean AoP between 1,800 rpm support and no HVAD support. In contrast, in the heart failure condition, HVAD flow at 1,800 rpm significantly contributed to mean AoP and total flow, because there was less regurgitant flow. CONCLUSIONS: Similar to the results for the HeartMate II at 6,000 rpm, we found that the net pump flow generated by the HeartWare HVAD at 1,800 rpm depends on the degree of residual left ventricular (LV) function. In the setting of improved LV function, at 1,800 rpm we noted a large regurgitant flow. Although this "marker" can serve as a useful indicator for recovery, assessing recovery at this speed is flawed unless measures are taken to prevent regurgitant flow.

Failure of the right ventricle represents a significant clinical problem and may have different causes, with rates varying between 5% and 50% in patients supported by a left ventricular assist device (LVAD). However, treatment options and device development for right ventricular failure (RVF) have significantly lagged behind those for LVADs. Newer technologies designed or adapted for RV support are needed to provide adequate long-term circulatory support. In this review, we discuss (1) the significance of RVF and its physiologic implications, (2) device constraints affecting treatment options for RVF, and (3) implantable VADs potentially available for RV support.

The choice of optimal operative access technique for mechanical circulatory support device implantation ensures successful postoperative outcomes. In this study, we retrospectively evaluated the median sternotomy and lateral thoracotomy incisions for placement of the Cleveland Clinic continuous-flow total artificial heart (CFTAH) in a bovine model. The CFTAH was implanted in 17 calves (Jersey calves; weight range, 77.0-93.9 kg) through a median sternotomy (n = 9) or right thoracotomy (n = 8) for elective chronic implantation periods of 14, 30, or 90 days. Similar preoperative preparation, surgical techniques, and postoperative care were employed. Implantation of the CFTAH was successfully performed in all cases. Both methods provided excellent surgical field visualization. After device connection, however, the median sternotomy approach provided better visualization of the anastomoses and surgical lines for hemostasis confirmation and repair due to easier device displacement, which is severely limited following right thoracotomy. All four animals sacrificed after completion of the planned durations (up to 90 days) were operated through full median sternotomy. Our data demonstrate that both approaches provide excellent initial field visualization. Full median sternotomy provides larger viewing angles at the anastomotic suture line after device connection to inflow and outflow ports.

BACKGROUND: Diabetes mellitus (DM) is a risk factor for mortality among patients with heart failure as well as for patients who undergo cardiothoracic surgery. However it is unknown whether DM is associated with increased mortality or major complications during continuous-flow left ventricular assist device (CF-LVAD) support. METHODS AND RESULTS: We retrospectively reviewed 300 consecutive adults who received CF-LVADs at a single center in the years 2006-2013; 129 patients had DM before LVAD, as defined by American Diabetes Association criteria (HbA1c >/=6.5% and/or taking DM medications). Compared with the non-DM group, DM patients were older, with a higher pre-LVAD body mass index, more ischemic heart failure etiology, and higher pre-LVAD creatinine. Ninety-three patients died on LVAD support, 43 with DM and 50 without DM (P = .4526). After control for 9 covariates in a Cox proportional hazards model, DM was unassociated with all-cause mortality (hazard ratio 0.883, 95% confidence interval 0.571-1.366; P = .5768). Diabetes was also unassociated with the adverse event end points of stroke/transient ischemic attack, intracerebral hemorrhage, pump thrombosis, and device-related infections. CONCLUSIONS: Diabetes is common in LVAD recipients (43% of the present cohort) but does not increase mortality or rates of major adverse events during CF-LVAD support.