Sarah Schettle

Role of ventricular assist therapy for patients with heart failure and restrictive physiology: Improving outcomes for a lethal disease.

BACKGROUND Restrictive cardiomyopathy (RCM) patients have poor prognosis due to progressive heart failure characterized by impaired ventricular filling of either or both ventricles. The goal of this study was to evaluate the outcome of end-stage RCM patients after left ventricular assist device (LVAD) implantation and to determine factors that may be associated with improved survival. METHODS This investigation is a retrospective study of prospectively collected data that include 28 consecutive patients with end-stage RCM who received continuous-flow LVADs at the Mayo Clinic, Rochester, Minnesota. Outcome was assessed by survival with LVAD support until heart transplantation or all-cause mortality. RESULTS The mean follow-up time post-LVAD implantation was 448 ± 425 days. The mean hospitalization time was 29 ± 19 days and was complicated mainly by post-operative right ventricular (RV) failure requiring short-term medical support. The short-term in-hospital mortality was 14%. Ten patients underwent heart transplantation with 100% survival post-transplant during the follow-up period. One-year survival for patients with LVADs without transplantation was 64%, and was not significantly different between amyloidosis and non-amyloidosis patients. Larger left ventricle (LV) end-diastolic and end-systolic dimensions were significantly associated with improved survival rates (RR = 0.94 and 0.95, p < 0.05, respectively), and left ventricular end-diastolic diameter (LVEDD) ≤46 mm was associated with increased mortality post-LVAD implantation. CONCLUSIONS LVAD is a feasible, life-saving therapy for end-stage heart failure related to RCM, especially as a bridge to transplant and in patients with larger LV dimensions.

Continuous-flow left ventricular assist devices and gastrointestinal bleeding: Potential role of danazol

Gastrointestinal (GI) bleeding is a common complication and a major cause of hospitalizations in patients supported with axial continuous-flow left ventricular assist devices (LVADs). Danazol was used in a small series of patients with congenital von Willebrand disease (VWD) to treat GI bleeding secondary to arteriovenous malformations (AVMs). We initiated danazol therapy in an LVAD patient with recurrent GI bleeding due to AVMs. Our hypothesis was that similar to treatment of AVMs in VWD, Danazol would be efficacious for LVAD patients.

Attenuation in Peripheral Endothelial Function After Continuous Flow Left Ventricular Assist Device Therapy Is Associated With Cardiovascular Adverse Events

BACKGROUND Patients with heart failure (HF) have abnormal endothelial function. Although use of a continuous flow left ventricular assist device (CF-LVAD) results in significant hemodynamic improvement, the effects on systemic endothelial function are unclear. METHODS AND RESULTS Eighteen HF patients with CF-LVAD implantation were included in this prospective observational study. We measured reactive hyperemia index (RHI) before and after CF-LVAD implantation to evaluate sequential changes in endothelial function. Patients were followed clinically for the occurrence of adverse cardiovascular events, a composite of death, thrombosis, bleeding, HF, renal failure, and arrhythmia. Preoperative RHI was 1.77±0.39. Early in the postoperative period (7-14 days after operation) RHI significantly decreased to 1.19±0.31 (P<0.001, compared with preoperative RHI). At first and second follow-up (4-6 weeks and 3-7 months after operation) RHI remained lower at 1.48±0.50 (P=0.030) and 1.26±0.37 (P=0.002), respectively, compared with preoperative RHI. The decrease in early postoperative RHI relative to preoperative RHI was significantly associated with adverse cardiovascular events after CF-LVAD (age-adjusted risk ratio for 0.25 decrease in RHI, 1.35; 95% confidence interval: 1.13-1.62, P=0.001). CONCLUSIONS Peripheral endothelial function had a significant and persistent decline up to 5 months following implantation of CF-LVAD, and this decline was associated with adverse cardiovascular events. These findings may provide insight into some of the vascular complications following CF-LVAD in HF patients.

Impact of Diabetes Mellitus on Outcomes in Patients Supported With Left Ventricular Assist Devices: A Single Institutional 9-Year Experience

Background Diabetes mellitus (DM) is a risk factor for morbidity and mortality in patients with heart failure. The effect of DM on post–left ventricular assist device (LVAD) implantation outcomes is unclear. This study sought to investigate whether patients with DM had worse outcomes than patients without DM after LVAD implantation and whether LVAD support resulted in a better control of DM. Methods and Results We retrospectively reviewed 341 consecutive adults who underwent implantation of LVAD from 2007 to 2016. Patient characteristics and adverse events were studied and compared between patients with and without DM. One hundred thirty-one patients (38%) had DM. Compared with patients without DM, those with DM had higher rates of ischemic cardiomyopathy, LVAD implantation as destination therapy, and increased baseline body mass index. In a proportional hazards (Cox) model with adjustment for relevant covariates and median follow-up of 16.1 months, DM was associated with increased risk of all-cause mortality (hazard ratio, 1.73; 95% confidence interval: 1.18–2.53; P=0.005) and increased risk of nonfatal LVAD-related complications, including a composite of stroke, pump thrombosis, and device infection (hazard ratio, 2.1; 95% confidence interval: 1.35–3.18; P=0.001). Preoperative hemoglobin A1c was not significantly associated with mortality or adverse events among patients with DM. LVAD implantation resulted in a remarkable decrease in hemoglobin A1c levels (7.4±1.9 pre-LVAD versus 6.0±1.5 and 6.3±1.4 after 3 and 12 months post-LVAD, respectively; P<0.0001) and a significant reduction in requirements of DM medications. Conclusions DM is associated with increased rates of all-cause mortality and major adverse events despite favorable glycemic control after LVAD implantation.

Percutaneous Driveline Fracture Following Implantation of the HeartMate II Left Ventricular Assist Device: How Durable is Driveline Repair?

Durability of the percutaneous driveline is critical for the optimal long-term support of patients after left ventricular assist device (LVAD) implantation. There are no data specifically examining the durability of major repair for driveline fracture or its effect on patient outcomes. Between May 2004 and August 2014, 560 patients underwent implantation with the HeartMate II LVAD at our respective institutions. Median age at LVAD implantation was 59 years (range 18–82 years) and 465 patients (83%) were male. The indication for LVAD implantation was bridge to transplant (BTT) in 296 patients (53%). Follow-up was available in all early survivors (n = 519) for a total of 940 patient-years of support (median 1.1 years, max. 10.4 years). Percutaneous driveline fracture was identified in 17 patients (3.2%), eight of whom were implanted as destination therapy. Median time from LVAD implantation to driveline fracture was 1.3 years (range, from 4 months to 3.8 years). Two of these patients underwent device exchange as primary treatment, while 15/17 (88%) underwent repair. Three of these 15 patients required a driveline reintervention, including device exchange (n = 1), rerepair (n = 1), and ungrounded cables (n = 1). Median time of support after driveline repair was 10 months (range from 3 months to 5.4 years). There were no late deaths after driveline repair during the follow-up period with 14/15 patients (93%) active on support and one having undergone transplant. The incidence of percutaneous driveline fracture after HeartMate II LVAD implantation is low (3.9%). The majority of driveline repairs for driveline fracture are durable with reintervention required in a minority of patients. There was no adverse effect of driveline fracture requiring repair on late outcome noted in this series with all patients either active on support or transplanted at last follow-up.

LEFT VENTRICULAR ASSIST DEVICE THERAPY IN PATIENTS WITH ADULT CONGENITAL HEART DISEASE

As a result of advancements in surgical repair and treatment, there are an increasing number of patients with congenital heart disease surviving into adulthood. Continuous flow left ventricular assist devices (LVAD) have been infrequently used in those patients that develop end stage heart failure,

Hemodynamic Assessment of Patients With and Without Heart Failure Symptoms Supported by a Continuous-Flow Left Ventricular Assist Device

Objective: To investigate differences in invasive hemodynamic parameters and outcomes in patients with and without heart failure (HF) symptoms after left ventricular assist device (LVAD) implantation. Patients and Methods: We performed a single‐center retrospective analysis of 51 symptomatic patients and 50 patients with resolved HF symptoms who underwent right‐sided heart catheterization (RHC) after LVAD implantation from March 1, 2007, through June 30, 2016. Patient characteristics and outcomes including all‐cause mortality and right ventricular (RV) failure were compared between groups. Results: Fifty‐one patients had development of HF symptoms after LVAD implantation and underwent RHC a mean ± SD of 243.7±288 days postoperatively. Fifty asymptomatic LVAD recipients underwent routine RHC 278.6±205 days after implantation. Compared with patients who had resolved HF symptoms, symptomatic patients were older, more likely to be male, and more likely to have ischemic cardiomyopathy. Symptomatic patients had higher right atrial pressure (P<.001), mean pulmonary arterial pressure (P<.001), and pulmonary capillary wedge pressure (P<.001). Improvements in right atrial pressure, mean pulmonary arterial pressure, and pulmonary capillary wedge pressure before and after LVAD implantation were less remarkable in symptomatic patients. The frequency of RV dysfunction was significantly higher among symptomatic patients than patients with resolved HF symptoms (P=.001). Symptomatic patients displayed significantly higher risk of all‐cause mortality (hazard ratio, 3.0; 95% CI, 1.3‐6.5; P=.007) and RV failure (hazard ratio, 6.2; 95% CI, 1.3‐29.7; P=.02) independent of other predictors of outcome. Conclusion: Patients with recurrent HF symptoms after LVAD implantation display more profound hemodynamic derangements, greater burden of RV failure, and increased rates of all‐cause mortality compared with LVAD recipients with resolved HF symptoms.