Advanced Heart Failure Treated with Continuous-Flow Left Ventricular Assist Device

Slaughter, Mark S.; Rogers, Joseph G.; Milano, Carmelo A.; Russell, Stuart D.; Conte, John V.; Feldman, David S.; Sun, Benjamin; Tatooles, Antone; Delgado, Reynolds M.; Long, James W.; Wozniak, Thomas; Ghumman, Waqas; Farrar, David J.; Frazier, O.H.

doi:10.1056/nejmoa0909938

Cited by 2,778 publications

(1,965 citation statements)

References 22 publications

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“…Survival, transplantation rates, and hospitalizations were similar during follow‐up. Mortality rates noted in our study are comparable to randomized trials of CF‐LVAD as well as prior studies evaluating ICD therapies in LVADs 1, 2, 6, 19, 20…”

Section: Discussionsupporting

confidence: 87%

“…VAs are commonly seen following LVAD implantation, with the incidence ranging from 24% to 52% 2, 13, 21, 22. Multiple mechanisms contribute but delayed incidence of VAs is mostly secondary to pre‐existing substrate combined with a lack of favorable remodeling from the LVADs 23, 24.…”

Section: Discussionmentioning

confidence: 99%

“…Continuous flow LVADs (CF‐LVADs) have been shown to improve mortality, morbidity, functional status, and quality of life in patients with advanced HF 2, 3, 4. Ventricular arrhythmias, however, are commonly seen in patients with LVAD,5, 6, 7 and the vast majority of LVAD recipients who had implantable cardioverter defibrillators (ICDs) continue to receive ICD therapies post‐LVAD implant 8.…”

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confidence: 99%

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Cardiac Resynchronization Therapy and Clinical Outcomes in Continuous Flow Left Ventricular Assist Device Recipients

Gopinathannair

Roukoz

Bhan

et al. 2018

JAHA

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BackgroundMany patients with heart failure continue cardiac resynchronization therapy (CRT) after continuous flow left ventricular assist device (CF‐LVAD) implant. We report the first multicenter study to assess the impact of CRT on clinical outcomes in CF‐LVAD patients.Methods and ResultsAnalysis was performed on 488 patients (58±13 years, 81% male) with an implantable cardioverter defibrillator (ICD) (n=223) or CRT‐D (n=265) who underwent CF‐LVAD implantation at 5 centers from 2007 to 2015. Effects of CRT on mortality, hospitalizations, and ventricular arrhythmia incidence were compared against CF‐LVAD patients with an ICD alone. Baseline differences were noted between the 2 groups in age (60±12 versus 55±14, P<0.001) and QRS duration (159±29 versus 126±34, P=0.001). Median biventricular pacing in the CRT group was 96%. During a median follow‐up of 478 days, Kaplan–Meier analysis showed no difference in survival between groups (log rank P=0.28). Multivariate Cox regression demonstrated no survival benefit with type of device (ICD versus CRT‐D; P=0.16), whereas use of amiodarone was associated with increased mortality (hazard ratio 1.77, 95% confidence interval 1.1–2.8, P=0.01). No differences were noted between CRT and ICD groups in all‐cause (P=0.06) and heart failure (P=0.9) hospitalizations, ventricular arrhythmia incidence (43% versus 39%, P=0.3), or ICD shocks (35% versus 29%, P=0.2). During follow‐up, 69 (26%) patients underwent pulse generator replacement in the CRT‐D group compared with 36 (15.5%) in the ICD group (P=0.003).ConclusionsIn this large, multicenter CF‐LVAD cohort, continued CRT was not associated with improved survival, hospitalizations, incidence of ventricular arrhythmia and ICD therapies, and was related to a significantly higher number of pulse generator changes.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Cardiac Resynchronization Therapy and Clinical Outcomes in Continuous Flow Left Ventricular Assist Device Recipients

Gopinathannair

Roukoz

Bhan

et al. 2018

JAHA

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“…It is worth noting that published data showed that the initial device strategy did not necessarily correspond to the final use of the device; BTT and DT are unlikely to be mutually exclusive categories 25, 28, 29. For example, in the randomized controlled trial of LVAD (continuous‐flow device vs. pulsatile‐flow device), 13% of DT patients received a donor heart within 2 years after implantation 30. On the other hand, less than 50% of BTT patients had received a donor heart 2 years after LVAD implantation 31.…”

Section: Discussionmentioning

confidence: 99%

Cost‐effectiveness of left ventricular assist devices for patients with end‐stage heart failure: analysis of the French hospital discharge database

Tadmouri¹,

Blomkvist²,

Landais³

et al. 2017

ESC Heart Failure

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AimsAlthough left ventricular assist devices (LVADs) are currently approved for coverage and reimbursement in France, no French cost‐effectiveness (CE) data are available to support this decision. This study aimed at estimating the CE of LVAD compared with medical management in the French health system.Methods and resultsIndividual patient data from the ‘French hospital discharge database’ (Medicalization of information systems program) were analysed using Kaplan–Meier method. Outcomes were time to death, time to heart transplantation (HTx), and time to death after HTx. A micro‐costing method was used to calculate the monthly costs extracted from the Program for the Medicalization of Information Systems. A multistate Markov monthly cycle model was developed to assess CE. The analysis over a lifetime horizon was performed from the perspective of the French healthcare payer; discount rates were 4%. Probabilistic and deterministic sensitivity analyses were performed. Outcomes were quality‐adjusted life years (QALYs) and incremental CE ratio (ICER). Mean QALY for an LVAD patient was 1.5 at a lifetime cost of €190 739, delivering a probabilistic ICER of €125 580/QALY [95% confidence interval: 105 587 to 150 314]. The sensitivity analysis showed that the ICER was mainly sensitive to two factors: (i) the high acquisition cost of the device and (ii) the device performance in terms of patient survival.ConclusionsOur economic evaluation showed that the use of LVAD in patients with end‐stage heart failure yields greater benefit in terms of survival than medical management at an extra lifetime cost exceeding the €100 000/QALY. Technological advances and device costs reduction shall hence lead to an improvement in overall CE.

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“…Continuous‐flow LV assist devices (LVADs) are becoming the standard of care for management of refractory advanced heart failure patients 14, 15, 16, 17. Although implantation of an LVAD leads to mechanical unloading of the LV, may induce ventricular reverse remodeling, and generally improves TR in the short term,18, 19, 20 nonimprovement of significant preoperative TR or TR worsening (namely “residual TR”) is observed in some patients during mid‐ to long‐term LVAD support.…”

Section: Introductionmentioning

confidence: 99%

Prevalence, Predictors, and Prognostic Value of Residual Tricuspid Regurgitation in Patients With Left Ventricular Assist Device

Nakanishi

Homma

Han

et al. 2018

JAHA

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BackgroundAlthough implantation of a left ventricular assist device (LVAD) generally improves tricuspid regurgitation (TR) in short‐term follow‐up, the clinical significance of residual TR in patients with mid‐ to long‐term LVAD support is unknown. This study aimed to identify the prevalence, predictors, and prognostic value of residual TR in LVAD patients in association with tricuspid valve (TV) deformation.Methods and ResultsThe study cohort consisted of 127 patients who underwent LVAD implantation without TV procedure and were supported with LVAD at least 1 year. All patients underwent echocardiographic examination preoperatively and 1 year after LVAD implantation. TR was quantitatively assessed by ratio of TR color jet area/right atrial area, and significant residual TR was defined as ≥20% of %TR at follow‐up echocardiographic examination. Detailed echocardiographic measurements were also performed, including TV annulus diameter, TV leaflet displacement, and left ventricular and right ventricular systolic function. LVAD implantation significantly improved ratio of TR color jet area/right atrial area as well as left ventricular and right ventricular systolic function and tethering distance (all P<0.05), whereas it enlarged TV annulus diameter (P=0.002). Significant residual TR was observed in 30 (23.6%) patients. Age, preoperative TV annulus diameter, and residual mitral regurgitation were significantly associated with significant residual TR (all P<0.05), whereas TV tethering was not. During a mean follow‐up of 21±17 months, patients with residual TR had significantly higher mortality than those without residual TR (log‐rank P<0.001).ConclusionsSignificant residual TR was observed in ≈25% patients supported with LVAD over 1 year and was associated with unfavorable outcome.

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Advanced Heart Failure Treated with Continuous-Flow Left Ventricular Assist Device

Cited by 2,778 publications

References 22 publications

Cardiac Resynchronization Therapy and Clinical Outcomes in Continuous Flow Left Ventricular Assist Device Recipients

Cardiac Resynchronization Therapy and Clinical Outcomes in Continuous Flow Left Ventricular Assist Device Recipients

Cost‐effectiveness of left ventricular assist devices for patients with end‐stage heart failure: analysis of the French hospital discharge database

Prevalence, Predictors, and Prognostic Value of Residual Tricuspid Regurgitation in Patients With Left Ventricular Assist Device

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