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Determinants of Functional Capacity and Quality of Life After Implantation of a Durable Left Ventricular Assist Device.

ABSTRACT: Continuous-flow left ventricular assist devices (LVAD) are increasingly used as destination therapy in patients with end-stage heart failure and, with recent improvements in pump design, adverse event rates are decreasing. Implanted patients experience improved survival, quality of life (QoL) and functional capacity (FC). However, improvement in FC and QoL after implantation is not unequivocal, and this has implications for patient selection and preimplantation discussions with patients and relatives. This article identifies preimplantation predictors of lack of improvement in FC and QoL after continuous-flow LVAD implantation and discusses potential mechanisms, allowing for the identification of potential factors that can be modified. In particular, the pathophysiology behind insufficient improvement in peak oxygen uptake is discussed. Data are included from 40 studies, resulting in analysis of >700 exercise tests. Mean peak oxygen uptake was 13.4 ml/kg/min (equivalent to 48% of predicted value; 259 days after implantation, range 31-1,017 days) and mean 6-minute walk test distance was 370 m (182 days after implantation, range 43-543 days). Finally, the interplay between improvement in FC and QoL is discussed.

SUBMITTER: Mirza KK

PROVIDER: S-EPMC7592460 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Determinants of Functional Capacity and Quality of Life After Implantation of a Durable Left Ventricular Assist Device.

Mirza Kiran K KK Gustafsson Finn F

Cardiac failure review 20200301

Continuous-flow left ventricular assist devices (LVAD) are increasingly used as destination therapy in patients with end-stage heart failure and, with recent improvements in pump design, adverse event rates are decreasing. Implanted patients experience improved survival, quality of life (QoL) and functional capacity (FC). However, improvement in FC and QoL after implantation is not unequivocal, and this has implications for patient selection and preimplantation discussions with patients and rela ...[more]

PMID: 33133643

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Project description:Background Factors related to health-related quality of life (HRQOL) 2 years after left ventricular assist device (LVAD) implantation are unknown. We sought to determine whether preimplant intended goal of LVAD therapy (heart transplant candidate [short-term group], uncertain heart transplant candidate [uncertain group], and heart transplant ineligible [long-term group]) and other variables were related to HRQOL 2 years after LVAD implantation. Methods and Results Our LVAD sample (n=1620) was from INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). Using the EuroQol-5 Dimension Questionnaire (EQ-5D-3L), a generic HRQOL measure, and the Kansas City Cardiomyopathy Questionnaire (KCCQ-12), a heart failure-specific HRQOL measure, multivariable linear regression modeling was conducted with the EQ-5D-3L Visual Analog Scale (VAS) score and KCCQ-12 overall summary score (OSS) as separate dependent variables. Two years after LVAD implant, the short-term group had a significantly higher mean VAS score versus the uncertain and long-term groups (short-term: 75.18 [SD, 20.62]; uncertain: 72.27 [SD, 20.33]; long-term: 70.87 [SD, 22.09], P=0.01); differences were not clinically meaningful. Two-year mean scores did not differ by group for the KCCQ-12 OSS (short-term, 67.85 [SD, 20.61]; uncertain, 67.79 [SD, 19.31]; long-term, 67.08 [SD, 21.49], P=0.80). Factors associated with a worse VAS score 2 years postoperatively (n=1205) included not working; not having a short-term LVAD; and postoperative neurological dysfunction, greater health-related stress, coping poorly, less VAD self-care confidence, and less satisfaction with VAD surgery, explaining 28% of variance (P<0.001). Factors associated with a worse KCCQ-12 OSS 2 years postoperatively (n=1250) included not working; history of high body mass index and diabetes mellitus; and postoperative renal dysfunction, greater health-related stress, coping poorly, less VAD self-care confidence, less satisfaction with VAD surgery, and regret regarding VAD implantation, accounting for 36% of variance (P<0.001). Conclusions Factors related to HRQOL 2 years after LVAD implantation include demographic, clinical, and psychological variables.

Project description:BackgroundThe HeartMate 3 (HM3) left ventricular assist device (LVAD) (Abbott, Inc, Chicago, Ill) is a fully magnetically levitated centrifugal implantable pump used to treat patients with chronic heart failure. The MOMENTUM (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) trial demonstrated that patients treated with the HM3 experienced reduced need for reoperation for LVAD replacement compared with a control group receiving an axial flow design, Heartmate II (Abbott, Inc). However, there are few reports of using HM3 as the replacement pump in patients who already are supported by a durable LVAD and experience a device-related complication necessitating replacement.MethodsAn institutional LVAD database was used to identify 19 consecutive patients who underwent pump replacement to HM3 (group 1) versus 85 consecutive control patients who underwent pump replacement to either Heartmate II or HeartWare Ventricular Assist Device (Medtronic Inc, Minneapolis, Minn) (group 2), at a single institution from January 2010 to August 2018. Patient baseline characteristic and outcomes were obtained from a prospectively maintained database. The primary endpoint was a composite of freedom from death or need for another replacement surgery.ResultsThere was no difference between the groups in heart failure etiology, indication for replacement, as well as the average days on the previous pump or the type of previous pump. The HM3 group did have a significantly greater body mass index (37 vs 31.6 P = .01), a greater number of previous LVAD implants (36.8% vs 5.9%, had 2 previous LVADs, P < .001), and a greater number of previous sternotomies (31.6% vs 7.1%, had 3 previous sternotomies, P = .001). No difference was found between the groups in terms of postoperative adverse event rates. With regards to the primary endpoint, the patients with HM3 replacements (group 1) versus group 2 experienced significantly greater freedom from either death or need for another replacement during the follow-up period (P = .039). During follow-up, there were no thrombosis events for the patients who received replacement with HM3.ConclusionsLVAD replacement with HM3 can be performed safely and may be considered as the pump of choice in patients requiring LVAD replacement.

Project description:Importance:Hospitalizations for durable left ventricular assist device (LVAD) implants are expensive and increasingly common. Insights into center-level variation in Medicare spending for these hospitalizations are needed to inform value improvement efforts. Objective:To examine center-level variation in Medicare spending for durable LVAD implant hospitalizations and its association with clinical outcomes. Design, Setting, and Participants:Retrospective cohort study of linked Medicare administrative claims and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) clinical data comprising 106 centers in the United States providing durable LVAD implant. Centers were grouped into quartiles based on the mean price-standardized Medicare spending of their patients. The study included Medicare beneficiaries receiving primary durable LVAD implant between January 2008 and December 2014. Data were analyzed between November 2017 and October 2018. Main Outcomes and Measures:Price-standardized Medicare payments and clinical outcomes. Overall and component (facility diagnosis-related group payments, outlier payments, physician services) payments and clinical outcomes (postimplant length of stay and adverse events) were compared across payment quartiles. Results:The study sample included 4442 hospitalized patients, with mean (SD) age of 63.0 (10.8) years, 18.7% female, 27.2% nonwhite, and 6.1% Hispanic ethnicity. Among 4442 hospitalizations, the mean (SD) price-standardized Medicare payment was $176 825 ($60 286) and ranged from $122 953 to $271 472 across 106 centers. The difference in price-standardized payments between lowest and highest spending quartiles was $55 446 ($152 714 vs $208 160; 36%; P < .001), with outlier payments making up most of the difference ($42 742; 77%), followed by DRG ($6929; 13%) and physician services ($5774; 10%). After risk standardization, there was a modest decline in the difference in payments between quartiles ($53 221; 35%), with outlier payments accounting for a larger proportion of the difference (84%). After adjusting for patient characteristics, higher price-standardized payment quartiles were associated with longer postimplant length of stay but were not associated with any adverse events. Conclusions and Relevance:Medicare payments for durable LVAD implant hospitalizations vary widely across centers; this was not well explained by prices or case mix. While associated with longer postimplant length of stay, increased spending was not associated with adverse events. As the supply and demand for durable LVAD therapy continues to rise, identifying opportunities to reduce variation in spending from both explained and unexplained sources will ensure high-value use.

Dataset Information

Determinants of Functional Capacity and Quality of Life After Implantation of a Durable Left Ventricular Assist Device.

Publications

Determinants of Functional Capacity and Quality of Life After Implantation of a Durable Left Ventricular Assist Device.

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