Intravascular Microaxial Left Ventricular Assist Device Manufacturer Payments to Cardiologists and Use of Devices.

This study examines whether payments from a left ventricular assist device manufacturer to cardiologists performing percutaneous coronary intervention were associated with any use of the devices.

Trends, Perioperative Adverse Events, and Survival of Patients With Left Ventricular Assist Devices Undergoing Noncardiac Surgery.

Importance: Information regarding the performance and outcomes of noncardiac surgery (NCS) in patients with left ventricular assist devices (LVADs) is scarce, with limited longitudinal follow-up data that are mostly limited to single-center reports. Objective: To examine the trends, patient characteristics, and outcomes associated with NCS among patients with LVAD. Design, Setting, and Participants: This cohort study examined patients enrolled in Medicare undergoing durable LVAD implantation from January 2012 to November 2017 with follow-up through December 2017. The study included all Medicare Provider and Analysis Review Part A files for the years 2012 to 2017. Patients identified by International Classification of Diseases, Ninth Revision Clinical Modification (ICD-9-CM) and International Classification of Diseases, Tenth Revision (ICD-10) procedure codes for new LVAD implantation were included. Data analysis was performed from November 2019 to February 2020. Exposures: NCS procedures were identified using the ICD-9-CM and ICD-10 procedural codes and divided into elective and urgent or emergent. Main Outcomes and Measures: The primary outcome was major adverse cardiovascular events (MACEs), defined as in-hospital or 30-day all-cause mortality, ischemic stroke, or intracerebral hemorrhage after NCS. Early (<60 days after NCS) and late (≥60 days after NCS) mortality after NCS were analyzed in both subgroups using time-varying covariate and landmark analysis using patients who did not undergo NCS as reference. Results: Of the 8118 patients with LVAD (mean [SD] age, 63.4 [10.8] years; 6484 men [79.9%]), 1326 (16.3%, or approximately 1 in 6) underwent NCS, of which 1000 procedures (75.4%) were emergent or urgent and 326 (24.6%) were elective. There was no difference in age between patients who underwent NCS and patients who did not (mean [SD] age, 63.6 [10.6] vs 63.4 [10.9] years). The number of NCS procedures among patients with LVAD increased from 64 in 2012 to 304 in 2017. The median (interquartile range) time from LVAD implantation to NCS was 309 (133-606) days. The most frequent type of NCS was general (613 abdominal, pelvic, and gastrointestinal procedures [46.2%]). Perioperative MACEs occurred in 169 patients (16.9%) undergoing emergent or urgent NCS and 23 patients (7.1%) undergoing elective NCS. Urgent or emergent NCS was associated with higher mortality early (adjusted hazard ratio [aHR], 8.78; 95% CI, 7.20-10.72; P < .001) and late (aHR, 1.71; 95% CI, 1.53-1.90; P < .001) after NCS compared with patients with LVAD who did not undergo NCS. Elective NCS was also associated with higher mortality early (aHR, 2.65; 95% CI, 1.74-4.03; P < .001) and late (aHR, 1.29; 95% CI, 1.07-1.56; P = .008) after NCS. Conclusions and Relevance: One of 6 patients with LVAD underwent NCS. Perioperative MACEs were frequent. Higher mortality risk transcended the early postoperative period in urgent or emergent and elective surgical procedures.

Clinical presentation and outcomes in women and men with advanced heart failure.

OBJECTIVE: To examine clinical characteristics and outcomes in women and men referred for advanced heart failure (HF) therapies such as left ventricular assist device (LVAD) or heart transplantation (HTx). Design: A retrospective study of 429 (23% women) consecutive adult HF patients not on inotropic or mechanical circulatory support with left ventricular ejection fraction ≤45% referred for assessment of advanced HF therapies at a single tertiary institution between 2002 and 2016. Clinical characteristics and outcomes were compared in women and men, and all patients underwent right heart catheterization (RHC). Results: At evaluation, women were younger than men (48 ± 13 vs. 51 ± 12 years, p = .02), and less likely to have ischemic cardiomyopathy. There were no significant differences in NYHA class, contemporary HF therapy use, or physical examination findings, except for lower jugular vein distension and body surface area in women. On RHC, women had lower cardiac filling pressures, but similar pulmonary vascular resistance and cardiac index. Peak oxygen uptake from cardiopulmonary exercise testing was similar in both sexes. At total follow-up time, there were 164 deaths (21% vs. 44%, p < .0001), 46 LVADs (3% vs. 13%, p = .005), 110 HTxs (32% vs. 25%, p = .15), and 82 HTxs without requiring LVAD (29% vs. 16%, p = .03) in women and men. The time from RHC to HTx (±LVAD) was significantly shorter in women compared to men. Female sex was significantly associated with higher survival independent of time-trend, age, and comorbidities. Conclusion: At evaluation, hemodynamics were less deranged in women. A higher proportion of women received HTx, their waitlist time was shorter, and survival greater.

Is the Affordable Care Act Medicaid Expansion Linked to Change in Rate of Ventricular Assist Device Implantation for Blacks and Whites?

BACKGROUND: The Affordable Care Act (ACA) has been associated with increased heart transplant listings among blacks, who are disproportionately uninsured. It is unclear whether the ACA is also associated with increased ventricular assist device implantation in blacks. METHODS: Using Healthcare Cost and Utilization Project Data State Inpatient Databases from 19 states and Washington DC, we analyzed 1157 patients from early-adopter states (ACA Medicaid expansion by January 2014) and 785 patients from nonadopter states (no implementation from 2013 to 2014). Piecewise Poisson regression with a discontinuity was used to estimate change in census-adjusted rates of ventricular assist device implants by race and ACA adopter status 1 year before and after January 2014. RESULTS: Following the ACA Medicaid expansion, the proportional change in rate increased significantly among blacks from early adopter (1.40 [95% CI, 1.12-1.75], pre 0.57/100 000 to post-ACA 0.80/100 000) but not nonadopter states (1.25 [95% CI, 0.98-1.58], pre 0.40/100 000 to post-ACA 0.50/100 000). However, the early and nonadopter changes in implantation rates were not statistically different from each other (P=0.50). There were no immediate changes in whites in either state group following the ACA Medicaid expansion (early adopter, 1.12 [95% CI, 0.98-1.29], pre 0.27/100 000 to post-ACA 0.30/100 000; nonadopter, 0.98 [95% CI, 0.82-1.16], pre 0.27/100 000 to post-ACA 0.26/100 000). CONCLUSIONS: Among eligible states participating in Healthcare Cost and Utilization Project Data State Inpatient Databases, the ACA was not associated with immediate changes in ventricular assist device implantation rates by race. Although a significant increase in implantation rate was observed among blacks from early-adopter states, the change was not statistically different from the change seen in nonadopter states.

The Society of Thoracic Surgeons Intermacs 2019 Annual Report: The Changing Landscape of Devices and Indications.

BACKGROUND: The field of mechanical circulatory support has been impacted by the approval of new continuous-flow left ventricular assist devices (LVADs) and changes to the United States heart allocation system. METHODS: Primary isolated continuous-flow LVAD implants in The Society of Thoracic Surgeons Intermacs registry from January 2014 through September 2019 were evaluated. Survival and freedom from major adverse events were compared between axial-flow, centrifugal-flow with hybrid levitation (CF-HL), and centrifugal-flow with full magnetic levitation (CF-FML) devices. RESULTS: Of 2603 devices implanted in 2014, 1824 (70.1%) were axial flow and 1213 (46.6%) were destination therapy (DT); through September 2019, 1752 devices were implanted, but only 37 (2.1%) were axial flow and 1230 (70.2%) were DT. Implants were performed in 13,016 patients between 2014 and 2018. Patients receiving implants in 2017-2018 compared with 2014-2016 were more likely to be at Intermacs profile 1 (17.1% vs 14.3%, P < .001) and to have preimplant temporary mechanical circulatory support (34.8% vs 29.3%, P < .001). Overall survival and freedom from major adverse events were higher with CF-FML devices. In multivariable analysis of survival between CF-HL and CF-FML, device type was not a significant early hazard, but the use of CF-HL devices had a late hazard ratio for death of 3.01 (P < .001). CONCLUSIONS: Over the past 5 years, centrifugal-flow LVADs have become the dominant technology and DT the most common implant strategy. While outcomes with CF-FML devices are promising, comparisons with other devices from nonrandomized registry studies should be made with caution.

Trends and Cost of Heart Transplantation and Left Ventricular Assist Devices: Impact of Proposed Federal Cuts.

OBJECTIVES: The purpose of this study was to compare trends of use, in-hospital mortality, and annual expenditures associated with orthotopic heart transplantation (OHT) and left ventricular assist device (LVAD) implantation. In view of the changing health care landscape, we assessed the impact of federal funding cuts on Medicare and Medicaid beneficiaries seeking these procedures. BACKGROUND: Use and cost trends associated with OHT and LVAD are not well defined. Moreover, little is known about the economic contribution of Medicare and Medicaid for these procedures. METHODS: Using the National Inpatient Sample from 2009 through 2014, the study identified index hospitalizations for OHT and LVAD. The aforementioned trends and inflation-adjusted cost analyses were performed. RESULTS: A total of 28,765 hospitalizations associated with OHT or LVAD were identified. The number of index hospitalizations for OHT increased from 1,795 to 2,140, whereas the number of LVAD implants increased from 2,205 to 3,645 (ptrend <0.001 for both). Unadjusted in-hospital mortality declined significantly from 17% to 12% (ptrend = 0.013) but remained unchanged for OHT (4.5% and 6.6%, respectively; ptrend = 0.30). The annual expenditure increased from ∼$288 to $451 million for OHT and from ∼$400 to $800 million for LVAD during the study period. Overall, Medicare and Medicaid contributed to more than 50% of the costs associated with these hospitalizations. CONCLUSIONS: With increasing use and annual expenditure, OHT and LVAD account for more than 1 billion dollars of the health care budget. In-hospital mortality associated with LVAD has continued to decline but has remained higher than that with OHT. Medicare and Medicaid beneficiaries seeking these procedures would be adversely affected by the proposed cuts.

National trends, predictors of use, and in-hospital outcomes in mechanical circulatory support for cardiogenic shock.

AIMS: Despite rising rates of cardiogenic shock (CS), data on trends and in-hospital outcomes of short-term non-durable mechanical circulatory support (MCS) are limited. Thus, we aimed to identify recent national trends in MCS utilisation in the USA, patient-level predictors of MCS use, and in-hospital outcomes in CS inclusive of extracorporeal membrane oxygenation (ECMO). METHODS AND RESULTS: Hospitalisations of US adults with a discharge diagnosis of CS, from January 2004 to December 2014, in the National Inpatient Sample were included. Rates of MCS were stratified by device type and clinical presentation. Outcomes included in-hospital mortality, hospitalisation costs, and number of procedures. A total of 183,516 hospitalisations with CS (47,636 [25.9%] involving MCS) were included. MCS recipients were younger, less frequently female, received more procedures, had higher costs, and more frequently presented with MI (MCS vs. non-MCS: 71.6% vs. 42.9%; p<0.0001). Growth in CS hospitalisations (214.4%) outpaced annual MCS use (160.0%), with relative declines in intra-aortic balloon pump use starting in 2008. Right heart catheterisation rates for both groups remained low (MCS vs. non-MCS: 5.9% vs. 3.3%; p<0.0001). In-hospital mortality declined but remained high in both groups (MCS vs. non-MCS [2014]: 32.7% vs. 41.5%; p<0.0001). CONCLUSIONS: In-hospital mortality for CS has declined but remains high. Rates of CS have outpaced MCS utilisation which remains uncommon in non-MI hospitalisations with shock. MCS is associated with utilisation of other procedures during hospitalisation.

Outcomes of catheter ablation of ventricular tachycardia with mechanical hemodynamic support: An analysis of the Medicare database.

INTRODUCTION: There is a paucity of data in favor of mechanical support during catheter ablation of ventricular tachycardia (VT). This study investigated the outcomes of VT ablation associated with mechanical support using percutaneous ventricular assist device (PVAD) versus intra-aortic balloon pump (IABP). METHODS AND RESULTS: We retrospectively examined the outcomes of patients who underwent VT ablation associated with PVAD versus IABP from 2010 to 2013, captured by the Medicare Inpatient Standard Analytic File database. Data from 345 patients (PVAD = 230, IABP = 115) were examined. On admission, the incidence of heart failure was higher in PVAD (84.3% vs. 73.0%; P = 0.01) with similar rates of renal failure in PVAD versus IABP (33.0% vs. 37.4%; P = 0.42). However, PVAD was associated with reduced in-hospital cardiogenic shock (9.1% vs. 23.5%; P  <  0.001), renal failure (11.7% vs. 21.7%; P = 0.01), and length of stay (8.4 ± 7.9 vs. 10.6 ± 7.5; P < 0.001), but with greater hospital discharges to home/self-care (66.0% vs. 51.6%; P = 0.02). Index mortality (6.5% vs. 19.1%; P = 0.001) and mortality in patients with cardiogenic shock (18.2% vs. 41.2%; P = 0.03) were significantly lower with PVAD versus IABP. Furthermore, PVAD was associated with lower all-cause (27.0% vs. 38.7%; P = 0.04) and heart failure-related (21.4% vs. 33.3%; P = 0.03) 30-day hospital readmissions, but with similar redo-VT ablation rates at 1 year (10.2% vs. 14.0%; P = 0.34). CONCLUSION: Among the cases captured by the Medicare database, catheter ablation of VT associated with mechanical support using PVAD was associated with reduced in-hospital cardiogenic shock, renal failure, length of stay, hospital readmissions and mortality, but no difference in redo-VT ablation at 1 year.

New Innovations in Circulatory Support With Ventricular Assist Device and Extracorporeal Membrane Oxygenation Therapy.

The past decade has seen an exponential increase in the application and development of durable long-term as well as nondurable short-term mechanical circulatory support for cardiogenic shock and acute or chronic heart failure. Support has evolved from bridge-to-transplant to destination therapy, bridge to rescue, bridge to decision making, and bridge to a bridge. Notable trends include device miniaturization, minimally invasive and/or percutaneous insertion, and efforts to superimpose pulsatility on continuous flow. We can certainly anticipate that innovation will accelerate in the months and years to come. However, despite-or perhaps because of-the enhanced equipment now available, mechanical circulatory support is an expensive, complex, resource-intensive modality. It requires considerable expertise that should preferably be centralized to highly specialized centers. Formidable challenges remain: systemic inflammatory response syndromes and vasoplegia after device insertion; postoperative sepsis; optimal anticoagulation regimens to prevent device-induced thrombosis and cerebral thromboembolism; wound site, intracranial, and gastrointestinal bleeding; multisystem injury and failure; patient dissatisfaction (even when providers consider the procedure a "success"); and ethical decision making in conditions of futility.

Indicações de dispositivos mecânicos de suporte na insuficiência cardíaca refratár / Indications of mechanical support devices in refractory heart failur

A insuficiência cardíaca refratária e o choque cardiogênico estão relacionados aelevadas taxas de mortalidade e a baixa qualidade de vida. As estratégias de tratamento para esses pacientes foram limitadas, nos últimos anos, às terapias farmacológicas que pouco modificaram a evolução da doença. Entretanto, com o desenvolvimento tecnológico em dispositivos mecânicos de suporte circulatório, diversas modalidades terapêuticas utilizando diferentes tipos de tecnologia proporcionam melhor suporte hemodinâmico, diminuição e reversão de disfunções orgânicas causadas pela insuficiência cardíaca.Esses dispositivos quando indicados corretamente melhoram os desfechos clínicos de pacientes que aguardam transplante cardíaco e dos que não são candidatos a transplante. Atualmente, observam-se indicações cada vez mais precoces de dispositivos de suporte circulatório, tornando-os uma terapia essencial no manejo de pacientes cominsuficiência cardíaca refratária ou choque cardiogênico. Esta revisão abordará os principais tipos de dispositivos disponíveis em nosso país e suas indicações...

The refractory heart failure and cardiogenic shock are related to high rates of mortality and poor quality of life. Treatment strategies for these patients have been limited in the last yearsto pharmacological therapies that change only slightly the evolution of the disease. However, with technological advances in mechanical devices for circulatory assistance, various therapeutic modalities using different types of technology provide better hemodynamic support, reduction and reversal of organic dysfunction caused by heart failure. When properly indicated,these devices can provide better clinical outcomes of patients on heart transplantation waiting list and those who are not candidates for transplantation. Contemporarily, indications for mechanical support devices are occurring increasingly earlier, making them an essential therapy in the management of patients with refractory heart failure or cardiogenic shock.This review covers the different types of devices available in our country and its indications...

Use of Post-acute Care Services and Readmissions After Left Ventricular Assist Device Implantation in Privately Insured Patients.

BACKGROUND: Very little is known about health care resource utilization, including post-acute care use and hospital readmissions, after left ventricular assist device (LVAD) implantation. METHODS AND RESULTS: Administrative claims from a database of multiple United States health plans were used to identify patients that received an LVAD (ICD-9 code 37.66) and survived to hospital discharge from January 1-2006, through September 30-2013. Post-acute care use was defined as a skilled nursing facility or rehabilitation stay within 90 days after hospital discharge. Patients were censored at heart transplantation or end of coverage through December 31-2013. Of 583 patients (mean age 55 years, 77% male), 223 (38.3%) used post-acute care services, more commonly in patients with diabetes, who required hemodialysis, and who had LVADs implanted at hospitals in more populated areas, with more beds, and in the northeast region (P < .05 for each). The most common reasons for readmission were device complications, heart failure, and arrhythmia. Readmission risk was higher in patients who had diabetes, peripheral vascular disease, and longer hospital length of stay, but it did not differ by post-acute care use. CONCLUSIONS: Use of post-acute care services varies based on hospital characteristics. We found no association between post-acute care use and readmission risk after LVAD implantation.

Inhaled Milrinone After Left Ventricular Assist Device Implantation.

BACKGROUND: Proven strategies to reduce right ventricular (RV) dysfunction after continuous-flow left ventricular assist device (CF-LVAD) implantation are lacking. We sought to evaluate the tolerability, feasibility, efficacy, and pharmacokinetics of inhaled milrinone (iMil) delivery after CF-LVAD implantation. METHODS AND RESULTS: We prospectively evaluated fixed-dose nebulized iMil delivered into a ventilator circuit for 24 hours in 10 postoperative CF-LVAD (Heartmate-II) patients. Tolerability (arrhythmias, hypotension, and hypersensitivity reaction), efficacy (hemodynamics), pharmacokinetics (plasma milrinone levels), and cost data were collected.Mean age was 56 ± 9 years, 90% were male, and mean INTERMACS profile was 2.5 ± 0.8. No new atrial arrhythmia events occurred, although 3 (30%) ventricular tachycardia (1 nonsustained, 2 sustained) events occurred. Sustained hypotension, drug hypersensitivity, death, or need for right ventricular assist device were not observed. Invasive mean pulmonary arterial pressure from baseline to during iMil therapy was improved (P = .017). Mean plasma milrinone levels (ng/mL) at baseline, and 1, 4, 8, 12, and 24 hours were 74.2 ± 35.4, 111.3 ± 70.9, 135.9 ± 41.5, 205.0 ± 86.7, 176.8 ± 61.3 187.6 ± 105.5, respectively. Reduced institutional cost was observed when iMil was compared with nitric oxide therapy over 24 hours ($165.29 vs $1,944.00, respectively). CONCLUSIONS: iMil delivery after CF-LVAD implantation was well tolerated, feasible, and demonstrated favorable hemodynamic, pharmacokinetic, and cost profiles. iMil therapy warrants further study in larger clinical trials.

The Use of Pediatric Ventricular Assist Devices in Children's Hospitals From 2000 to 2010: Morbidity, Mortality, and Hospital Charges.

OBJECTIVE: The use of ventricular assist devices has increased dramatically in adult heart failure patients. However, the overall use, outcome, comorbidities, and resource utilization of ventricular assist devices in pediatric patients have not been well described. We sought to demonstrate that the use of ventricular assist devices in pediatric patients has increased over time and that mortality has decreased. DESIGN: A retrospective study of the Pediatric Health Information System database was performed for patients 20 years old or younger undergoing ventricular assist device placement from 2000 to 2010. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Four hundred seventy-five pediatric patients were implanted with ventricular assist devices during the study period: 69 in 2000-2003 (era 1), 135 in 2004-2006 (era 2), and 271 in 2007-2010 (era 3). Median age at ventricular assist device implantation was 6.0 years (interquartile range, 0.5-13.8), and the proportion of children who were 1-12 years old increased from 29% in era 1 to 47% in era 3 (p = 0.002). The majority of patients had a diagnosis of cardiomyopathy; this increased from 52% in era 1 to 72% in era 3 (p = 0.003). Comorbidities included arrhythmias (48%), pulmonary hypertension (16%), acute renal failure (34%), cerebrovascular disease (28%), and sepsis/systemic inflammatory response syndrome (34%). Two hundred forty-seven patients (52%) underwent heart transplantation and 327 (69%) survived to hospital discharge. Hospital mortality decreased from 42% in era 1 to 25% in era 3 (p = 0.004). Median hospital length of stay increased (37 d [interquartile range, 12-64 d] in era 1 vs 69 d [interquartile range, 35-130] in era 3; p < 0.001) and median adjusted hospital charges increased ($630,630 [interquartile range, $227,052-$853,318] in era 1 vs $1,577,983 [interquartile range, $874,463-$2,280,435] in era 3; p < 0.001). Factors associated with increased mortality include age less than 1 year (odds ratio, 2.04; 95% CI, 1.01-3.83), acute renal failure (odds ratio, 2.1; 95% CI, 1.26-3.65), cerebrovascular disease (odds ratio, 2.1; 95% CI, 1.25-3.62), and extracorporeal membrane oxygenation (odds ratio, 3.16; 95% CI, 1.79-5.60). Ventricular assist device placement in era 3 (odds ratio, 0.3; 95% CI, 0.15-0.57) and a diagnosis of cardiomyopathy (odds ratio, 0.5; 95% CI, 0.32-0.84), were associated with decreased mortality. Large-volume centers had lower mortality (odds ratio, 0.55; 95% CI, 0.34-0.88), lower use of extracorporeal membrane oxygenation, and higher charges. CONCLUSIONS: The use of ventricular assist devices and survival after ventricular assist device placement in pediatric patients have increased over time, with a concomitant increase in resource utilization. Age under 1 year, certain noncardiac morbidities, and the use of extracorporeal membrane oxygenation are associated with worse outcomes. Lower mortality was seen at larger volume ventricular assist device centers.

Heart transplantation versus continuous-flow left ventricular assist device: comprehensive cost at 1 year.

BACKGROUND: With health care reform firmly on the horizon, it is critical to understand the costs associated with new technologies such as continuous-flow left ventricular assist device (CF-LVAD) compared with well established treatments such as heart transplantation (HT). Scarce data exist describing the costs of these 2 therapies after 1 year of support. METHODS AND RESULTS: The study population consisted of 20 consecutive subjects who underwent implantation of a CF-LVAD and 20 consecutive subjects who underwent HT and survived ≥1 year. Comprehensive cost calculation included all direct and indirect costs from day of operation through 365 days and were inflation adjusted to 2010 US dollars. Hospital charges were converted to costs with the use of hospital-specific cost-to-charge ratios and were analyzed by time segment as well as cost center. The total 1-year cost was higher in the CF-LVAD group, although this difference did not reach statistical significance ($369,519 [interquartile range [IQR] $321,020-$520,395] vs $329,648 [IQR $278,924-$395,456]; P = .242). In both groups, the index admission constituted >50% of the total 1-year cost and the major drivers of expense by cost center were organ/device acquisition, room and board, and professional fees. CONCLUSIONS: Patients surviving to 1 year on CF-LVAD support accrued costs similar to those of HT recipients; however, the total cost, at more than one-third of a million dollars, remains high. Reduction in the postoperative length of stay offers an avenue for significant cost savings.

Cost-effectiveness of left ventricular assist devices (LVADs) for patients with advanced heart failure: analysis of the British NHS bridge to transplant (BTT) program.

BACKGROUND: A previous cost-effectiveness analysis showed that bridge to transplant (BTT) with early design left ventricular assist devices (LVADs) for advanced heart failure was more expensive than medical management while appearing less beneficial. Older LVADs were pulsatile, but current second and third generation LVADs are continuous flow pumps. This study aimed to estimate comparative cost-effectiveness of BTT with durable implantable continuous flow LVADs compared to medical management in the British NHS. METHODS AND RESULTS: A semi-Markov multi-state economic model was built using NHS costs data and patient data in the British NHS Blood and Transplant Database (BTDB). Quality-adjusted life years (QALYs) and incremental costs per QALY were calculated for patients receiving LVADs compared to those receiving inotrope supported medical management. LVADs cost £80,569 ($127,887) at 2011 prices and delivered greater benefit than medical management. The estimated probabilistic incremental cost-effectiveness ratio (ICER) was £53,527 ($84,963)/QALY (95%CI: £31,802-£94,853; $50,479-$150,560) (over a lifetime horizon). Estimates were sensitive to choice of comparator population, relative likelihood of receiving a heart transplant, time to transplant, and LVAD costs. Reducing the device cost by 15% decreased the ICER to £50,106 ($79,533)/QALY. CONCLUSIONS: Durable implantable continuous flow LVADs deliver greater benefits at higher costs than medical management in Britain. At the current UK threshold of £20,000 to £30,000/QALY LVADs are not cost effective but the ICER now begins to approach that of an intervention for end of life care recently recommended by the British NHS. Cost-effectiveness estimates are hampered by the lack of randomized trials.

Organ allocation in adults with congenital heart disease listed for heart transplant: impact of ventricular assist devices.

BACKGROUND: Adults with congenital heart disease (CHD) listed for heart transplantation are rarely supported by ventricular assist devices (VADs). This may be a disadvantage to their priority for organ allocation. We sought to determine the relationship between VAD implantation and successful transplantation among patients listed for heart transplant. METHODS: Adults with CHD patients (N = 1,250) were identified from the United Network for Organ Sharing (UNOS) database from 1985 to 2010 and compared to patients without congenital etiology for heart failure (N = 59,606). VAD use at listing, listing status, status upgrades and reasons for upgrade prior to transplant were trended at 5-year intervals and appropriate statistical comparisons were made between groups. RESULTS: Since 1985, VAD use prior to transplant has increased significantly in patients without CHD, but not in CHD patients (17% vs 3% in 2006 to 2010, p < 0.0001). CHD patients were more likely to be listed as Status 2, compared to those without (66% vs 40%, p < 0.001 for 2006 to 2010), and less likely to be upgraded to Status 1 after listing (43% vs 55%, p = 0.03). Among those upgraded to Status 1, CHD patients were less likely to have a VAD at transplant than those without (3% vs 18%, p = 0.005). VAD use was more likely to result in death in CHD patients. CONCLUSIONS: VAD use is less common in CHD patients than in patients without CHD, both at the time of listing and transplantation. Reduced VAD use appears to contribute to lower listing status and organ allocation. These differences have grown more disparate over time. Separate criteria for organ allocation for CHD patients may be justified.