Robert Larbalestier

A Prospective, Multicenter Trial of the VentrAssist Left Ventricular Assist Device for Bridge to Transplant : Safety and Efficacy

BACKGROUND The increasing prevalence of chronic heart failure has stimulated the ongoing development of left ventricular assist devices (LVADs) for both bridge-to-transplant (BTT) and destination therapy (DT). The aim of this prospective, multicenter clinical trial was to determine the efficacy and safety of a third-generation LVAD, the VentrAssist, in a BTT cohort. METHODS Patients (n = 33) with end-stage chronic heart failure who required circulatory support as BTT therapy were implanted with a VentrAssist device. The primary outcome was survival until transplant or transplant eligibility with the device in situ at trial end-point (Day 154 after implant). The secondary outcomes were pump flow index and end-organ function. Safety, patient functional status and resource use were also assessed. RESULTS At trial end-point, the success rate was 82% (39.4% transplanted, 42.4% transplant-eligible). The LVAD pump flow index (median >or=2.7 liters/min/m(2)) was sufficient to maintain an adequate circulation and significantly improve end-organ function. Of the 77 protocol-defined serious adverse events, most occurred within 30 days of implantation. No patients died as a direct result of pump failure or malfunction. After implantation, patient functional status improved, with 70% of patients achieving hospital discharge, and resource use was reduced. CONCLUSIONS This trial demonstrated a favorable efficacy and safety profile for use of the VentrAssist LVAD in BTT patients.

Management Options to Treat Gastrointestinal Bleeding in Patients Supported on Rotary Left Ventricular Assist Devices: A Single‐Center Experience

Gastrointestinal (GI) bleeding in ventricular assist devices (VADs) has been reported with rotary devices. The pathophysiological mechanisms and treatments are in evolution. We performed a retrospective review of GI bleeding episodes for all VADs implanted at our institution. Five male patients experienced GI bleeding-age 63.6 ± 3.64 years. VAD type VentrAssist n = 1, Jarvik 2000 n = 2, and HeartWare n = 2. All patients were anticoagulated as per protocol with antiplatelet agents (aspirin and/or clopidogrel bisulfate [Plavix] and warfarin (therapeutic international normalized ratio 2.0-3.5). There was no prior history of gastric bleeding in this group. Ten episodes of bleeding requiring blood transfusion occurred in five patients. Some patients had multiple episodes (1 × 5, 1 × 2, 3 × 1). The events occurred at varying times post-VAD implantation (days 14, 21, 26, 107, 152, 189, 476, 582, 669, and 839). Octreotide (a long-acting somatostatin analogue that reduces splanchnic arterial and portal blood flow) was administered subcutaneously or intravenously. Three patients received infusions of adrenaline at 1 µg/min to enhance pulsatility. Anticoagulation was interrupted during bleeding episodes but successfully introduced post bleeding event. GI bleeding is a significant complication of VAD therapy. In this article, we discuss diagnosis and management options.

Preoperative intraaortic balloon pumps in high-risk patients undergoing open heart surgery.

BACKGROUND The use of the preoperative intraaortic balloon pump (IABP) in patients with severe left ventricular dysfunction or unstable angina with critical coronary anatomy is becoming more frequent as surgical casemix changes. The aim of this study was to determine the impact of preoperative IABP use on survival in high-risk patients having open heart surgery. METHODS Prospectively collected data for 645 consecutive patients were reviewed. Patients receiving an IABP were identified and grouped as follows: group A (preoperative IABP for high-risk nonemergent cases), group B (preoperative IABP for emergent cases), and group C (intra/postoperative IABP). Risk-adjusted hospital mortality rates in these three groups was compared using the modified Parsonnet score for preoperative risk stratification. RESULTS IABPs were used in 101 cases (16%). The predicted versus actual hospital mortality rate was 20% versus 5.7% in group A, 32.1% versus 47.6% in group B, and 12.6% versus 22.2% in group C (group A vs group B, p = 0.0014; group A vs group C, p = 0.012). IABP-related morbidity occurred in 3% of cases (all in group C). CONCLUSIONS Risk-adjusted mortality was significantly lower in high-risk cases with preoperative IABPs compared with emergent cases and intraoperative/postoperative IABPs. We encourage the use of preoperative IABPs in selected high-risk patients.

Extent of Coronary and Myocardial Disease and Benefit From Surgical Revascularization in LV Dysfunction

BACKGROUND Patients with ischemic left ventricular dysfunction have higher operative risk with coronary artery bypass graft surgery (CABG). However, those whose early risk is surpassed by subsequent survival benefit have not been identified. OBJECTIVES This study sought to examine the impact of anatomic variables associated with poor prognosis on the effect of CABG in ischemic cardiomyopathy. METHODS All 1,212 patients in the STICH (Surgical Treatment of IsChemic Heart failure) surgical revascularization trial were included. Patients had coronary artery disease (CAD) and ejection fraction (EF) of ≤35% and were randomized to receive CABG plus medical therapy or optimal medical therapy (OMT) alone. This study focused on 3 prognostic factors: presence of 3-vessel CAD, EF below the median (27%), and end-systolic volume index (ESVI) above the median (79 ml/m(2)). Patients were categorized as having 0 to 1 or 2 to 3 of these factors. RESULTS Patients with 2 to 3 prognostic factors (n = 636) had reduced mortality with CABG compared with those who received OMT (hazard ratio [HR]: 0.71; 95% confidence interval [CI]: 0.56 to 0.89; p = 0.004); CABG had no such effect in patients with 0 to 1 factor (HR: 1.08; 95% CI: 0.81 to 1.44; p = 0.591). There was a significant interaction between the number of factors and the effect of CABG on mortality (p = 0.022). Although 30-day risk with CABG was higher, a net beneficial effect of CABG relative to OMT was observed at >2 years in patients with 2 to 3 factors (HR: 0.53; 95% CI: 0.37 to 0.75; p<0.001) but not in those with 0 to 1 factor (HR: 0.88; 95% CI: 0.59 to 1.31; p = 0.535). CONCLUSIONS Patients with more advanced ischemic cardiomyopathy receive greater benefit from CABG. This supports the indication for surgical revascularization in patients with more extensive CAD and worse myocardial dysfunction and remodeling. (Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease [STICH]; NCT00023595).

Chronic extra-aortic balloon counterpulsation: First-in-human pilot study in end-stage heart failure

BACKGROUND Some patients continue to have significant heart failure symptoms despite optimal medical therapy. METHODS We describe a first-in-human experience with an implantable non-blood-contacting extra-ascending aortic counterpulsation heart assist system (C-Pulse) in 5 end-stage heart failure patients, aged 54 to 73 years. RESULTS All patients improved by 1 NYHA class and improvements in invasive hemodynamics were documented in 3 patients. Three of 5 patients (60%) had infectious complications. Two patients were explanted at 5 and 7 weeks, respectively, as a result of mediastinal infection related to the implant procedure. One patient was successfully transplanted at 1 month and 1 remained hemodynamically improved on the device at 6 months but suffered infective complications. The device and protocol have been modified as a result of this pilot study with a further multicenter safety study underway. CONCLUSIONS Although feasibility of this device is suggested by this pilot study, safety and efficacy will need to be examined in a larger cohort with longer follow-up.

Incidence and prognosis of vascular complications after transcatheter aortic valve implantation.

OBJECTIVE Transcatheter aortic valve implantation (TAVI) has gained increasing global popularity as a minimally invasive option for high-risk cardiac patients. However, this operation is not without risk, particularly of significant vascular complications that increase the morbidity, mortality, and overall cost of the procedure. We aim to present our experience of TAVI-related vascular complications, including the morbidity and cost impacts of these events. METHODS A case-series study was performed for all patients undergoing TAVI at our center. Vascular complications were defined according to the 2011 Valve Academic Research Consortium standardized end points. The data were prospectively collected from February 2009 to April 2012, and the outcomes were entered into a database and cross-checked with the hospital notes. RESULTS TAVI was performed on 100 patients in our center during the study period, and the 30-day mortality was 6%. Access approaches included 81 transfemoral, 18 transapical, and one trans-subclavian access. The average patient age was 84.9 years, and 65% of the patients were male. Among the transfemoral procedures, there were 16 vascular access-related complications (VAC), including nine major and seven minor complications. The major complications included aortic dissection, iliac arterial rupture, femoral dissection, false aneurysms, and distal embolization, all of which required surgical or endovascular repair. An apical false aneurysm and an apical tear were major VAC of the transapical group, with the latter resulting in death. Patients with VAC had higher blood transfusion requirements (4.1 ± 4.5 units vs 0.9 ± 2.2 units; P = .004), greater length of hospital stay (16.4 ± 10.7 days vs 6.5 ± 5.1 days; P = .001), and increased cost (A

First Successful Bridge to Myocardial Recovery With a HeartWare HVAD

93,448 ± 21,435 vs A

Extent of coronary and myocardial disease and benefit from surgical revascularization in ischemic LV dysfunction [Corrected].

69,932 ± 15,007; P = .002) compared with the non-VAC group. The predictors of vascular complications using multivariate analysis included European System for Cardiac Operative Risk Evaluation (odds ratio, 1.06; 95% confidence interval, 1.02-1.10; P = .001) and diabetes mellitus (odds ratio, 5.07; 95% confidence interval, 1.17-21.88; P = .03). Occurrence of major VAC did not affect in-hospital or 30-day mortality rates and was not associated with poorer survival. CONCLUSIONS Vascular complications affect perioperative management and outcomes following TAVI. Our findings show that these complications often require urgent surgical or endovascular repair and result in increased blood transfusions, greater length of hospital stay, and significantly increased costs. Diabetes mellitus and logistic European System for Cardiac Operative Risk Evaluation may be predictive of VAC and should be considered during TAVI patient selection.

Cardiac reoperations in octogenerians

In this report we describe the first successful bridge to myocardial recovery with the HeartWare HVAD. Assessment for explantation included serial echocardiography, hemodynamic monitoring, metabolic analysis and manipulation of pump speed, both at rest and during exercise. A protocol for assessing the degree of myocardial recovery without stopping the device is described.

Clinical Outcomes of Patients Treated With Pulmonary Vasodilators Early and in High Dose After Left Ventricular Assist Device Implantation.

BACKGROUND Patients with ischemic left ventricular dysfunction have higher operative risk with coronary artery bypass graft surgery (CABG). However, those whose early risk is surpassed by subsequent survival benefit have not been identified. OBJECTIVES This study sought to examine the impact of anatomic variables associated with poor prognosis on the effect of CABG in ischemic cardiomyopathy. METHODS All 1,212 patients in the STICH (Surgical Treatment of IsChemic Heart failure) surgical revascularization trial were included. Patients had coronary artery disease (CAD) and ejection fraction (EF) of ≤35% and were randomized to receive CABG plus medical therapy or optimal medical therapy (OMT) alone. This study focused on 3 prognostic factors: presence of 3-vessel CAD, EF below the median (27%), and end-systolic volume index (ESVI) above the median (79 ml/m(2)). Patients were categorized as having 0 to 1 or 2 to 3 of these factors. RESULTS Patients with 2 to 3 prognostic factors (n = 636) had reduced mortality with CABG compared with those who received OMT (hazard ratio [HR]: 0.71; 95% confidence interval [CI]: 0.56 to 0.89; p = 0.004); CABG had no such effect in patients with 0 to 1 factor (HR: 1.08; 95% CI: 0.81 to 1.44; p = 0.591). There was a significant interaction between the number of factors and the effect of CABG on mortality (p = 0.022). Although 30-day risk with CABG was higher, a net beneficial effect of CABG relative to OMT was observed at >2 years in patients with 2 to 3 factors (HR: 0.53; 95% CI: 0.37 to 0.75; p<0.001) but not in those with 0 to 1 factor (HR: 0.88; 95% CI: 0.59 to 1.31; p = 0.535). CONCLUSIONS Patients with more advanced ischemic cardiomyopathy receive greater benefit from CABG. This supports the indication for surgical revascularization in patients with more extensive CAD and worse myocardial dysfunction and remodeling. (Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease [STICH]; NCT00023595).