Heart Replacement Therapy Research Articles

(738) - Need and Supply of Heart Replacement Therapy in Italy, with U.S. as Benchmark

(738) - Need and Supply of Heart Replacement Therapy in Italy, with U.S. as Benchmark

Anticoagulation management in mechanical circulatory support.

Heart failure continues to be a worldwide epidemic, effecting over 23 million persons. Despite advances in medical therapy, the disease is progressive and a significant proportion of patients will need advanced heart replacement therapy. Continuous flow assist devices have become a standard approach for many patients both as a bridge to cardiac transplantation and as destination therapy (DT). However, device related complications such as bleeding and thrombosis continue to hinder further advancements of this technology. The field is rapidly advancing and efforts to reduce pump complications are directed towards improving hemocompatibility and maximizing blood flow without clinically significant hemolysis, areas of stasis or turbulent flow.

Abstract 18846: Heart Rate Reserve, a Prognostic Marker for Heart Failure Hospitalizations and Adverse Outcomes

Introduction: Heart Failure hospitalization (HFH) is a major clinical event and economic burden. Heart Rate Reserve (HRR), a marker of chronotropic incompetence is associated with mortality, but its prognostic value in HF progression is unknown. Methods: In this multi-center study, HF patients with NYHA class 2-3, in sinus rhythm, on stable medical therapy underwent a cardiopulmonary exercise test (CPET) from 2008-2013 at Columbia University Medical Center and were prospectively followed for 3 endpoints: HFH, inotrope dependence or worse, and heart replacement therapy or death (HRT-D). Various clinical variables including HRR were evaluated and included in risk score models. The models with highest significance were validated in an independent cohort from Montefiore Medical Center Results: In the derivative cohort of 135 patients, low pVO2, HRR, and LVEF were significantly associated with all 3 endpoints. Using ROC analysis, HRR<45% was equivalent to pVO2<14 ml/kg/min in predicting all outcomes. The model using LVEF<30%, pVO2<14 ml/kg/min and HRR<45% as binary cut-offs (total score: 0-3) was able to stratify patients into different risk strata for freedom from HFH (p<0.001, Fig-1), freedom from inotrope dependence or worse (p<0.001) and from HRT-D (p<0.001, Fig-2) at 1 year. A simpler model using LVEF<30% and HRR<45% (total score: 0-2) was also able to risk stratify patients (p<0.001). These results were validated in an independent cohort of 294 patients. Conclusions: HRR is a strong predictor of outcomes in advanced HF. If a metabolic cart is unavailable, a simple risk score using HRR<45% and LVEF<30% alone can help clinicians identify patients at highest risk for HFH.

Ten-year survival and prognostic markers in one thousand patients with advanced heart failure. A single-centre analysis.

Patients with advanced heart failure (HF) represent a pool of candidates for heart transplantation and long-term mechanical circulatory support devices. The aim of our study was to determine simple and reliable markers of one-year mortality for selection of the most suitable patients for heart replacement therapy. One thousand consecutive patients with HF (mean age 49 ± 10.9 years; 86.8% males) referred to a single tertiary centre from January 1998 to January 2010 in order to assess the indication for heart transplantation were enrolled. Kaplan-Meier survival analysis was performed. Independent mortality predictors were established using logistic regression analysis. The mean follow-up was 4.3 ± 2.7 years (range 1-12 years). Cumulative survival was as follows: 1-year survival 83%, 3-year 63%, 5-year 50%, 7-year 39%, and 10-year 23%. Independent predictors of 1-year mortality included coronary artery disease, left ventricular diastolic diameter >79 mm, plasma sodium <135 mmol/L, the need for intravenous treatment at hospital admission (diuretics and/or inotropes), and furosemide dose at discharge >240 mg/day. Short-term prognosis of HF patient can be estimated based on simple parameters. Patients with signs of poor prognosis should be referred to tertiary centres to be considered for heart replacement therapy.

Comparison of Outcomes After Heart Replacement Therapy in Patients Over 65 Years Old

There are currently no well-defined, evidence-based guidelines for management of end-stage heart failure in patients over 65, and the decisions to use mechanical circulatory support with left ventricular assist device (LVAD), either as a bridge to transplantation or destination therapy, or isolated heart transplantation (HTx) remain controversial. We aimed to compare the outcomes after the implementation of three heart replacement strategies in this high-risk population. We conducted a retrospective cohort study of all patients between the ages of 65 and 72 receiving a continuous-flow LVAD as bridge to transplantation or destination therapy or isolated HTx at our center between 2005 and 2012. The patients were stratified according to treatment strategy into three groups: group D (destination LVAD, n = 23), group B (bridge to transplantation LVAD, n = 43), and group H (HTx alone, n = 47). The primary outcomes of interest were survival to discharge and 2-year overall survival. The patients in group D were significantly older, had a higher prevalence of ischemic cardiomyopathy, and had a higher pulmonary vascular resistance than did patients in groups B or H. There were no significant differences between groups in survival to discharge (87% D vs 83.7% B vs 87.2% H, p = 0.88) or 2-year overall survival (75.7% D vs 68.7% B vs 80.9% H, log-rank p = 0.47). The incidence rates of readmission were 1.1 events/patient·year in group D and 0.5 events/patient·year in group H. There was no significant difference in perioperative, short-term, and medium-term survival between the treatment groups. However, the LVAD patients had a higher incidence of readmission. Larger trials are needed to refine differences in long-term survival, quality of life, and resource utilization for elderly patients requiring heart replacement therapy.

Acquired von Willebrand Disease During CentriMag Support Is Associated with High Prevalence of Bleeding During Support and After Transition to Heart Replacement Therapy

The Levitronix CentriMag is a magnetically levitated centrifugal-flow pump that can be implanted rapidly in the operating room for both right and left ventricular support. Recently, continuous-flow pumps have been associated with excessive bleeding, which can be at least partially explained by acquired von Willebrand disease (vWD). We investigated whether acquired vWD occurs during CentriMag support and determined the frequency of bleeding complications during device support as well as after transition to long-term support. We found that acquired vWD is common early post CentriMag implantation and is associated with frequent bleeding events and high requirement of blood products.

Implantable Ventricular Assist Device Use in the Immunosuppressed Patient

Purpose A shortcoming of ventricular assist device (VAD) therapy is risk of driveline, pocket, or device infection. It is not uncommon for heart replacement therapy candidates to be on immunosuppressants. However, a VAD may not be offered, due to a theoretical infection risk. This study examined outcomes of patients with implantable VADs on immunosuppressants. Methods and Materials All patients on immunosuppressants receiving an implantable VAD between January 1996 and October 2012 were reviewed. All implantable pulsatile and non-pulsatile devices were included. Peripherally inserted VADs were excluded. Results Twenty-four patients were identified. Eight (33%) were on multiple immunosuppressants for prior transplant: 5 heart, 3 renal. The 16 remaining were on prednisone for thyrotoxicosis (n=6), myocarditis (n=3), sarcoidosis (n=3), pulmonary fibrosis (n=2), lupus erythematosis, and steroid abuse (n=1, each). Mean age was 44±19 years, with 88% male. Devices included 18 LVADs (4 pulsatile and 14 continuous-flow), and 6 BiVADs. Two LVAD patients received subsequent peripheral RVADs. All prior heart transplants required biventricular support. Overall, 92% of indications were bridge to transplant, with 73% transplanted, and 2 patients lost to follow-up. During a median 123 days on device (range 33-1102), 33% developed device-related infections: 4 driveline, 5 pocket, and one device. There was no 30-day mortality, with 87% 1-year survival. [ figure 1 ][ figure 1 ] Death resultant from sepsis occurred in 3 patients. Conclusions It is reasonable to utilize implantable VADs for heart replacement therapy in immunosuppressed patients. Prior transplant confers no additional infectious risk. VAD usage is successful as a bridge to transplant.