Health‐Related Quality of Life in Older Patients With Advanced Heart Failure: Findings From the SUSTAIN‐IT Study

Grady, Kathleen L.; Andrei, Adin-Cristian; Elenbaas, Christian; Warzecha, Anna; Baldridge, Abigail S.; Kao, Andrew; Spertus, John A.; Pham, D.; Dew, Mary Amanda; Hsich, Eileen; Cotts, William; Hartupee, Justin; Pamboukian, Salpy V.; Pagani, Francis D.; Petty, Michael; Lampert, Brent C.; Johnson, Maryl R.; Murray, Margaret; Takeda, Koji; Yuzefpolskaya, M.; Silvestry, Scott C.; Kirklin, James K.; Yancy, Clyde W.

doi:10.1161/jaha.121.024385

Cited by 10 publications

(10 citation statements)

References 34 publications

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“…The same was true for many data on baseline patient characteristics and outcome parameters. Many studies from our analysis did not include or report data on patient’s functional heart failure status (e.g., NYHA class) or LV function although these factors already have been proven extensively to have a large impact on quality of life [ 79 , 80 ]. However, many of the included trials either showed data on medical outcome (improvement of functional NYHA class, improvement of measured LV function) or parameters of psychological well-being (quality of life, mental diseases).…”

Section: Discussionmentioning

confidence: 99%

The Impact of Cardiac Devices on Patients’ Quality of Life—A Systematic Review and Meta-Analysis

Willy

Ellermann

Reinke

et al. 2022

JCDD

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The implantation of cardiac devices significantly reduces morbidity and mortality in patients with cardiac arrhythmias. Arrhythmias as well as therapy delivered by the device may impact quality of life of patients concerned considerably. Therefore we aimed at conducting a systematic search and meta-analysis of trials examining the impact of the implantation of cardiac devices, namely implantable cardioverter-defibrillators (ICD), pacemakers and left-ventricular assist devices (LVAD) on quality of life. After pre-registering the trial with the PROSPERO database, we searched Medline, PsycINFO, Web of Science and the Cochrane databases for relevant publications. Study quality was assessed by two independent reviewers using standardized protocols. A total of 37 trials met our inclusion criteria. Of these, 31 trials were cohort trials while 6 trials used a randomized controlled design. We found large pre-post effect sizes for positive associations between quality of life and all types of devices. The effect sizes for LVAD, pacemaker and ICD patients were g = 1.64, g = 1.32 and g = 0.64, respectively. There was a lack of trials examining the effect of implantation on quality of life relative to control conditions. Trials assessing quality of life in patients with cardiac devices are still scarce. Yet, the existing data suggest beneficial effects of cardiac devices on quality of life. We recommend that clinical trials on cardiac devices routinely assess quality of life or other parameters of psychological well-being as a decisive study endpoint. Furthermore, improvements in psychological well-being should influence decisions about implantations of cardiac devices and be part of patient education and may impact shared decision-making.

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Section: Discussionmentioning

confidence: 99%

The Impact of Cardiac Devices on Patients’ Quality of Life—A Systematic Review and Meta-Analysis

Willy

Ellermann

Reinke

et al. 2022

JCDD

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“…Reasons for not approaching patients included being too sick, timing of surgery, administrative reasons (eg, staffing issues), and other reasons. 26 Of 393 eligible enrollees, those who underwent surgery and had complete data at baseline, 3 months, or 6 months for either of the 2 outcomes (EQ-5D VAS or KCCQ-12) comprised the sample for this report (n=305): 68 HT MCS, 93 HT non-MCS, and 144 long-term MCS. Reasons for not undergoing HT or long-term MCS implant are listed in Figure 1 .…”

Section: Resultsmentioning

confidence: 99%

“…Our data were from the SUSTAIN-IT study (Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support). 26 Dr Andrei had full access to all data in the study and takes responsibility for its integrity and data analysis. For this report, we used a prospective, longitudinal, multi-site, observational design.…”

Section: Methodsmentioning

confidence: 99%

“…We hypothesized that factors associated with change in HRQOL will include comorbidities, patient group, and postoperative adverse events. We divided HT patients into 2 groups, with and without pretransplant MCS because we identified differences in HRQOL by HT group at enrollment 25 , 26 and wanted to determine if these differences persist early after HT. Examination of 3 time points (baseline, 3 months, and 6 months) is supported in the MCS HRQOL literature.…”

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confidence: 99%

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Health-Related Quality of Life in Older Patients With Heart Failure From Before to Early After Advanced Surgical Therapies: Findings From the SUSTAIN-IT Study

Grady

Kao

Spertus

et al. 2022

Circ: Heart Failure

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Background: Restoring health-related quality of life (HRQOL) is a therapeutic goal for older patients with advanced heart failure. We aimed to describe change in HRQOL in older patients (60–80 years) awaiting heart transplantation (HT) with or without pretransplant mechanical circulatory support (MCS) or scheduled for long-term MCS, if ineligible for HT, from before to 6 months after these surgeries and identify factors associated with change. Methods: Patients from 13 US sites completed the EuroQol 5-dimension 3L questionnaire and Kansas City Cardiomyopathy Questionnaire-12 at baseline and 3 and 6 months after HT or long-term MCS. Analyses included univariate comparisons and multivariable linear regression. Results: Among 305 participants (cohort mean age=66.2±4.7 years, 78% male, 84% White, 55% New York Heart Association class IV), 161 underwent HT (n=68 with and n=93 without pretransplant MCS), and 144 received long-term MCS. From baseline to 3 months, EuroQol 5-dimension visual analog scale scores improved in HT patients without pretransplant MCS (54.5±24.3 versus 75.9±16.0, P <0.001) and long-term MCS patients (45.7±22.9 versus 66.2± 20.9, P <0.001); while Kansas City Cardiomyopathy Questionnaire-12 overall summary scores improved in all 3 groups (HT without pretransplant MCS: 47.2±20.9 versus 77.4±20.1, P <0.001; long-term MCS: 35.3±20.2 versus 58.6±22.0, P <0.001; and HT with pretransplant MCS: 58.3±23.6 versus 72.1±23.5, P =0.002). No further HRQOL improvement was found from 3 to 6 months. Factors most significantly associated with change in HRQOL, baseline 3 months, were right heart failure and 3-month New York Heart Association class, and 3 to 6 months, were 6-month New York Heart Association class and major bleeding. Conclusions: In older heart failure patients, HRQOL improved from before to early after HT and long-term MCS. At 6 postoperative months, HRQOL of long-term MCS patients was lower than one or both HT groups. Understanding change in HRQOL from before to early after these surgeries may enhance decision-making and guide patient care. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02568930.

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“…Additional inclusion and exclusion criteria have been previously described. 27 Caregivers were approached after patients were enrolled, before implantation of long-term MCS or while awaiting HT. Caregivers were included if they were identified by the patient as the primary caregiver (ie, an unpaid family member or friend who helps the patient with self-care), age ≥21 years, able to speak, read, and write English, willing to participate, and able to provide informed consent.…”

Section: Sites and Samplementioning

confidence: 99%

Change in Caregiver Health-Related Quality of Life From Before to Early After Surgery: SUSTAIN-IT Study

Chuzi

Wilcox

Kao

et al. 2023

Circ: Heart Failure

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BACKGROUND: Information about health-related quality of life (HRQOL) among caregivers of older patients with heart failure who receive heart transplantation (HT) and mechanical circulatory support (MCS) is sparse. We describe differences and factors associated with change in HRQOL before and early post-surgery among caregivers of older heart failure patients who underwent 3 surgical therapies: HT with pretransplant MCS (HT MCS), HT without pretransplant MCS (HT non-MCS), and long-term MCS. METHODS: Caregivers of older patients (60–80 years) from 13 US sites completed the EQ-5D-3 L visual analog scale (0 [worst]–100 [best] imaginable health state) and dimensions before and 3 and 6 months post-surgery. Analyses included linear regression, t tests, and nonparametric tests. RESULTS: Among 227 caregivers (HT MCS=54, HT non-MCS=76, long-term MCS=97; median age 62.7 years, 30% male, 84% White, 83% spouse/partner), EQ-5D visual analog scale scores were high before (84.8±14.1) and at 3 (84.7±13.0) and 6 (83.9±14.7) months post-surgery, without significant differences among groups or changes over time. Patient pulmonary hypertension presurgery (β=−13.72 [95% CI, −21.07 to −6.36]; P <0.001) and arrhythmia from 3 to 6 months post-operatively (β=−14.22 [95% CI, −27.41 to −1.02]; P =0.035) were associated with the largest decrements in caregiver HRQOL; patient marital/partner status (β=6.21 [95% CI, 1.34–11.08]; P =0.013) and presurgery coronary disease (β=8.98 [95% CI, 4.07–13.89]; P <0.001) were associated with the largest improvements. CONCLUSIONS: Caregivers of older patients undergoing heart failure surgeries reported overall high HRQOL before and early post-surgery. Understanding factors associated with caregiver HRQOL may inform decision-making and support needs. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02568930.

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Health‐Related Quality of Life in Older Patients With Advanced Heart Failure: Findings From the SUSTAIN‐IT Study

Cited by 10 publications

References 34 publications

The Impact of Cardiac Devices on Patients’ Quality of Life—A Systematic Review and Meta-Analysis

The Impact of Cardiac Devices on Patients’ Quality of Life—A Systematic Review and Meta-Analysis

Health-Related Quality of Life in Older Patients With Heart Failure From Before to Early After Advanced Surgical Therapies: Findings From the SUSTAIN-IT Study

Change in Caregiver Health-Related Quality of Life From Before to Early After Surgery: SUSTAIN-IT Study

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