Cardiac replacement therapies: outcomes and costs for heart transplantation versus circulatory assist.

OBJECTIVES: Growing number of patients with terminal heart failure and a shortage of heart donors have increased use of short- and long-term mechanical circulatory support (MCS). Few studies have analyzed survival rates and healthcare costs for heart transplantation (HTx), with or without extracorporeal membrane oxygenation (ECMO) and left ventricular assist device (LVAD). DESIGN: In a retrospective, single-center study, data were analyzed from patients listed for HTx who died on the waiting list (DWL, n = 12), underwent HTx (n = 206), had ECMO as bridge to HTx (ECHTx, n = 15), or received LVAD treatment, either isolated (LVAD, n = 19) or bridging to HTx (LVADHTx, n = 26) during 2005-2012. Survival and hospital costs were assessed. RESULTS: One- and five-year survival rates were 96% and 83% for the LVADHTx group, 92% and 81% for HTx, 70% and 70% for ECHTx, 48% and 36% for LVAD and 0% for the DWL group (overall survival, p < 0.001). Total hospital cost at one year was $102,101 ± 202,604 for DWL, $151,685 ± 86,892 for HTx, $292,078 ± 101,915 for ECHTx, $427,337 ± 365,154 for LVAD, and $600,897 ± 198,109 for LVADHTx. CONCLUSION: The LVADHTx and HTx groups showed excellent one- and five-year survival. The combined group of DWL and HTx patients had similar survival to the combined groups of MCS, but use of LVAD pre-transplant quadrupled the cost.

Outcome in refractory out-of-hospital cardiac arrest before and after implementation of an ECPR protocol.

AIM: To compare the outcomes in patients with refractory out-of-hospital cardiac arrest (OHCA) fulfilling the criteria for extracorporeal cardiopulmonary resuscitation (ECPR) before and after implementation of an ECPR protocol, whether the patient received ECPR or not. METHODS: We compared cardiac arrest registry data before (2014-2015) and after (2016-2019) implementation of the ECPR protocol. The ECPR criteria were presumed cardiac origin, witnessed arrest with ventricular fibrillation, bystander CPR, age 18-65, advanced life support (ALS) within 15 min and ALS > 10 min without return of spontaneous circulation (ROSC). The primary outcome was 30-day survival; the secondary outcomes were sustained ROSC, neurological outcome and the proportion of patients transported with ongoing ALS. RESULTS: There were 1086 and 3135 patients in the pre- and post-implementation sample; 48 (4%) and 100 (3%) met the ECPR criteria, respectively. Of these, 21 (44%) vs. 37 (37%) were alive after 30 days, p = 0.4, and 30 (63%) vs. 50 (50%) achieved sustained ROSC, p = 0.2. All survivors in the pre-implementation sample had cerebral performance category 1-2 vs. 30 (81%) in the post-implementation sample, p = 0.03. Of the patients fulfilling the ECPR criteria, 7 (15%) and 26 (26%), p = 0.1, were transported with ongoing ALS in the pre- and post-implementation sample, respectively. CONCLUSIONS: There were no differences in 30-day survival or prehospital ROSC in patients with refractory OHCA before and after initiation of an ECPR protocol.

Long-term continuous flow mechanical biventricular support: 9 years and counting.

We report 2 continuous flow HeartWareTM left ventricular assist devices successfully used in a patient with advanced heart failure of giant cell myocarditis origin in a biventricular configuration. Despite technical challenges of adapting a left ventricular assist device engineered for systemic pressure to function as a right ventricular assist device, the addition of dynamic banding on the right ventricular assist device outflow graft allowed successful adaptation of afterload. This patient has now been on biventricular configuration support for 9 years, and remains stable to this day.

Influence of the ECMO circuit on the concentration of nutritional supplements.

Circulating compounds such as drugs and nutritional components might adhere to the oxygenator fibers and tubing during ECMO support. This study evaluated the amount of nutritional supplements adsorbed to the ECMO circuit under controlled ex vivo conditions. Six identical ECMO circuits were primed with fresh human whole blood and maintained under physiological conditions at 36 °C for 24 h. A dose of nutritional supplement calculated for a 70 kg patient was added. 150 mL volume was drawn from the priming bag for control samples and kept under similar conditions. Blood samples were obtained at predetermined time points and analyzed for concentrations of vitamins, minerals, lipids, and proteins. Data were analyzed using mixed models with robust standard errors. No significant differences were found between the ECMO circuits and the controls for any of the measured variables: cobalamin, folate, vitamin A, glucose, minerals, HDL cholesterol, LDL cholesterol, total cholesterol, triglycerides or total proteins. There was an initial decrease and then an increase in the concentration of cobalamin and folate. Vitamin A concentrations decreased in both groups over time. There was a decrease in concentration of glucose and an increased concentration of lactate dehydrogenase over time in both groups. There were no significant alterations in the concentrations of nutritional supplements in an ex vivo ECMO circuit compared to control samples. The time span of this study was limited, thus, clinical studies over a longer period of time are needed.

Accelerometer Detects Pump Thrombosis and Thromboembolic Events in an In vitro HVAD Circuit.

Pump thrombosis and stroke are serious complications of left ventricular assist device (LVAD) support. The aim of this study was to test the ability of an accelerometer to detect pump thrombosis and thromboembolic events (TEs) using real-time analysis of pump vibrations. An accelerometer sensor was attached to a HeartWare HVAD and tested in three in vitro experiments using different pumps for each experiment. Each experiment included thrombi injections sized 0.2-1.0 mL and control interventions: pump speed change, afterload increase, preload decrease, and saline bolus injections. A spectrogram was calculated from the accelerometer signal, and the third harmonic amplitude was used to test the sensitivity and specificity of the method. The third harmonic amplitude was compared with the pump energy consumption. The acceleration signals were of high quality. A significant change was identified in the accelerometer third harmonic during the thromboembolic interventions. The third harmonic detected thromboembolic events with higher sensitivity/specificity than LVAD energy consumption: 92%/94% vs. 72%/58%, respectively. A total of 60% of thromboembolic events led to a prolonged third harmonic amplitude change, which is indicative of thrombus mass residue on the impeller. We concluded that there is strong evidence to support the feasibility of real-time continuous LVAD monitoring for thromboembolic events and pump thrombosis using an accelerometer. Further in vivo studies are needed to confirm these promising findings.

International coordinator survey results on the outpatient management of patients with the HeartWare® ventricular assist system.

PURPOSE: While the HeartWare® Ventricular Assist System (HVAS) is a successful therapy for end-stage heart failure, outpatient management methods can vary significantly and require further investigation. METHODS: A survey to assess the long-term HVAS patient management and monitoring strategies was completed by 36 international heart centers that currently have over 1,450 patients on VAD support either at home or in the hospital. Multiple choice questions examined VAD program characteristics, anticoagulation management, driveline exit-site dressing and showering recommendations, blood pressure and pump parameter monitoring, and patient discharge protocols. RESULTS: Outpatient international normalized ratio (INR) was most frequently measured every 3-4 days (28.6%), and the most frequent schedule for changing driveline exit site dressings was 3 times per week (30.6%). Only 25.7% of centers required their patients to measure blood pressure at home. A subgroup analysis was performed to assess the influence of center experience and larger centers generally had more frequent monitoring compared to smaller centers. CONCLUSIONS: This survey showed specific differences in outpatient management strategies that were previously unreported. However, further studies with correlations to patient outcomes are necessary to determine optimal patient management recommendations.

Hospital costs fell as numbers of LVADs were increasing: experiences from Oslo University Hospital.

BACKGROUND: The current study was undertaken to examine total hospital costs per patient of a consecutive implantation series of two 3rd generation Left Ventricle Assist Devices (LVAD). Further we analyzed if increased clinical experience would reduce total hospital costs and the gap between costs and the diagnosis related grouped (DRG)-reimbursement. METHOD: Cost data of 20 LVAD implantations (VentrAssist™) from 2005-2009 (period 1) were analyzed together with costs from nine patients using another LVAD (HeartWare™) from 2009-June 2011 (period 2). For each patient, total costs were calculated for three phases - the pre-LVAD implantation phase, the LVAD implantation phase and the post LVAD implant phase. Patient specific costs were obtained prospectively from patient records and included personnel resources, medication, blood products, blood chemistry and microbiology, imaging and procedure costs including operating room costs. Overhead costs were registered retrospectively and allocated to the specific patient by predefined allocation keys. Finally, patient specific costs and overhead costs were aggregated into total hospital costs for each patient. All costs were calculated in 2011-prices. We used regression analyses to analyze cost variations over time and between the different devices. RESULTS: The average total hospital cost per patient for the pre-LVAD, LVAD and post-LVAD for period 1 was $ 585, 513 (range 132, 640- 1 247, 299), and the corresponding DRG- reimbursement (2009) was $ 143, 192 . The mean LOS was 54 days (range 12- 127). For period 2 the total hospital cost per patient was $ 413, 185 (range 314, 540- 622, 664) and the corresponding DRG- reimbursement (2010) was $ 136, 963. The mean LOS was 49 days (range 31- 93).The estimates from the regression analysis showed that the total hospital costs, excluding device costs, per patient were falling as the number of treated patients increased. The estimate from the trend variable was -14, 096 US$ (CI -3, 842 to -24, 349, p < 0.01). CONCLUSION: There were significant reductions in total hospital costs per patient as the numbers of patients were increasing. This can possibly be explained by a learning effect including better logistics, selection and management of patients.

Costs and reimbursement gaps after implementation of third-generation left ventricular assist devices.

BACKGROUND: The purpose of this study was to compare and contrast total hospital costs and subsequent reimbursement of implementing a new program using a third-generation left ventricular assist device (LVAD) in Norway. METHODS: Between July 2005 and March 2008, the total costs of treatment for 9 patients were examined. Costs were calculated for three periods-the pre-implantation LVAD phase, the LVAD implantation phase and the post-implantation LVAD phase-as well as for total hospital care. Patient-specific costs were obtained prospectively from patient records and included personnel resources, medication, blood products, blood chemistry and microbiology, imaging, and procedure costs including operating room costs. Overhead costs were registered retrospectively and allocated to the specific patient by pre-defined allocation keys. Finally, patient-specific costs and overhead costs were aggregated into total patient costs. RESULTS: The average total patient cost in 2007 U.S. dollars was $735,342 and the median was $613,087 (range $342,581 to $1,256,026). The mean length of stay was 77 days (range 40 to 127 days). For the LVAD implantation phase, the mean cost was $457,795 and median cost was $458,611 (range $246,239 to $677,680). The mean length of stay for the LVAD implantation phase was 55 days (range 25 to 125 days). The diagnosis-related group (DRG) reimbursement (2007) was $143,192. CONCLUSIONS: There is significant discrepancy between actual hospital costs and the current Norwegian DRG reimbursement for the LVAD procedure. This discrepancy can be partly explained by excessive costs related to the introduction of a new program with new technology. Costly innovations should be considered in price setting of reimbursement for novel technology.