Frailty and the selection of patients for destination therapy left ventricular assist device.
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ABSTRACT:
SUBMITTER: Flint KM
PROVIDER: S-EPMC3869992 | biostudies-literature | 2012 Mar
REPOSITORIES: biostudies-literature
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Frailty and the selection of patients for destination therapy left ventricular assist device.
Flint Kelsey M KM Matlock Daniel D DD Lindenfeld Joann J Allen Larry A LA
Circulation. Heart failure 20120301 2
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Project description:The left ventricular assist device was originally designed to be surgically implanted as a bridge to transplantation for patients with chronic end-stage heart failure. On the basis of the REMATCH trial, the US Food and Drug Administration and the US Centers for Medicare & Medicaid Services approved permanent implantation of the left ventricular assist device as a destination therapy in Medicare beneficiaries who are not candidates for heart transplantation. The use of the left ventricular assist device as a destination therapy raises certain ethical challenges. Left ventricular assist devices can prolong the survival of average recipients compared with optimal medical management of chronic end-stage heart failure. However, the overall quality of life can be adversely affected in some recipients because of serious infections, neurologic complications, and device malfunction. Left ventricular assist devices alter end-of-life trajectories. The caregivers of recipients may experience significant burden (e.g., poor physical health, depression, anxiety, and posttraumatic stress disorder) from destination therapy with left ventricular assist devices. There are also social and financial ramifications for recipients and their families. We advocate early utilization of a palliative care approach and outline prerequisite conditions so that consenting for the use of a left ventricular assist device as a destination therapy is a well informed process. These conditions include: (1) direct participation of a multidisciplinary care team, including palliative care specialists, (2) a concise plan of care for anticipated device-related complications, (3) careful surveillance and counseling for caregiver burden, (4) advance-care planning for anticipated end-of-life trajectories and timing of device deactivation, and (5) a plan to address the long-term financial burden on patients, families, and caregivers.Short-term mechanical circulatory devices (e.g. percutaneous cardiopulmonary bypass, percutaneous ventricular assist devices, etc.) can be initiated in emergency situations as a bridge to permanent implantation of ventricular assist devices in chronic end-stage heart failure. In the absence of first-person (patient) consent, presumed consent or surrogate consent should be used cautiously for the initiation of short-term mechanical circulatory devices in emergency situations as a bridge to permanent implantation of left ventricular assist devices. Future clinical studies of destination therapy with left ventricular assist devices should include measures of recipients' quality of end-of-life care and caregivers' burden.
| S-EPMC2527574 | biostudies-literature
Project description:Background The relevance of sex and preimplant factors for clinical outcomes among patients with left ventricular assist devices intended for destination therapy is unclear. Methods and Results INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) data (2006-2017) from 6771 men and 1690 women with left ventricular assist devices as destination therapy were analyzed to evaluate the contribution of preimplant clinical, demographic, and clinically judged psychosocial characteristics to time until death, heart transplant, device explant due to recovery, or complication-related device replacement. Associations of sex with time until each competing outcome were evaluated using cumulative incidence functions and event-specific Cox proportional hazards models. Women were younger, more likely to have nonischemic diagnoses, and reported less substance abuse but were more likely to be unmarried, not working for an income, overweight, and depressed than men. After 2 years, women had higher probabilities for recovery (3.7% versus 1.6%, P<0.001) and device replacement (12.1% versus 10%, P=0.019) than men but not for death and transplant (P>0.12). The sex differences remained after controlling for covariates (adjusted hazard ratio [HRadj] recovery, 1.85; 95% CI, 1.30-2.70; P<0.001; HRadj device replacement, 1.22; 95% CI, 1.04-1.33; P=0.015). Female-specific diagnoses (eg, postpartum heart failure) contributed to women's enhanced rate of recovery. Demographic and psychosocial factors were unrelated to women's increased event rates. Conclusions In destination therapy, women have higher rates of device replacement and recovery than men. The latter was partly explained by female-specific diagnoses. Standardized assessments of psychosocial characteristics are needed to elucidate their association with sex differences in outcomes.
| S-EPMC9075087 | biostudies-literature
Project description:BackgroundLeft ventricular assist devices (LVAD) are a therapeutic option in patients with advanced heart failure (HF) not a candidate for cardiac transplant as destination therapy (DT). However, important uncertainties remain regarding the use of LVAD in the long-term in real practice settings. When planning registries, it is important to choose the appropriate outcomes that ensure comparability and reduce the possibility of bias.AimThe purpose of this study was to establish a minimum dataset (MDS) that should be collected in all LVAD for DT registries to meet the needs and demands of Health Technology Assessment (HTA) doers and health professionals.MethodsTo design the MDS for LVAD, a preliminary list of outcome domains and data items were developed attending to the gaps and research needs derived from existing evidence coming from HTA carried out at the European Network of Health Technology Assessment (EUnetHTA) level. The list of data items and domains was agreed upon by all involved HTA organizations and a three-round Delphi was conducted among an experienced panel of cardiologists to rate the importance of the items for measuring uncertainty gaps.ResultsAfter the three-round Delphi process, the expert panel reached a consensus regarding eighteen outcomes and forty-seven variables divided into seven main domains (safety, effectiveness, patient acceptability, satisfaction, healthcare system impact, pharmaceutical management, and technique-related factors).ConclusionsThe MDS of outcomes and measures, developed based on research gaps and needs, can allow for standardizing data collection and improving the quality of data for decision making and practice.
| S-EPMC11811952 | biostudies-literature
Project description:BackgroundProgressive renal insufficiency is frequent in heart failure patients with a left ventricular assist device (LVAD). The optimal strategy for long-term dialysis in LVAD patients and its effect on quality-of-life in these patients remain to be determined.Case summaryOur 55-year-old patient with pre-existing renal insufficiency received an LVAD as destination therapy because of advanced ischaemic heart failure. Six years after implantation, he developed end-stage renal disease for which peritoneal dialysis (PD) was initiated. Left ventricular assist device flow alterations during ultrafiltration did not cause clinical or technical problems. The patient's exercise capacity increased and quality-of-life improved. Over 7.5 years after LVAD implantation and 16 months after PD initiation, he died from encephalitis.DiscussionDespite initial improvement, renal function often gradually decreases after LVAD implantation. Data on long-term renal replacement therapy in LVAD patients are limited. Haemodialysis is most commonly applied. Conceptually, however, PD has advantages over haemodialysis including less bloodstream infections, less haemodynamic shifts, and the comfort of the ambulant setting. This case illustrates that PD in an LVAD patient is feasible and improves quality-of-life. Key factors contributing to successful PD in LVAD patients may be a good right ventricular function and close cardiology-nephrology collaboration.
| S-EPMC8523880 | biostudies-literature
Project description:BackgroundFamily caregivers of patients with a destination therapy left ventricular assist device play a central and formalized role in postimplant care. We aimed to characterize longitudinal stress, predictors and correlates of stress, and coping processes among left ventricular assist device caregivers.MethodsWe performed a sequential, exploratory, mixed-methods study from 6 diverse left ventricular assist device programs. The primary outcome for the quantitative analysis was the Perceived Stress Scale-10 at 6 months (0-40). Based on the quantitative findings and guided by the Transactional Model of Stress and Coping, semistructured interviews explored causes of stress and coping processes. Integration was performed during the qualitative and interpretation phase.ResultsA total of 96 caregivers met inclusion criteria for quantitative analysis. Mean (SD) Perceived Stress Scale score was 14.3 (5.5) preimplant and 11.8 (6.9) at 6 months. Preimplant, only decreased preparedness for caregiving was associated with higher Perceived Stress Scale score at 6 months. At 6 months, increased caregiver depressive symptoms, decreased caregiver preparedness for caregiving, and lower patient quality of life were associated with higher Perceived Stress Scale score. Qualitative analysis of 25 caregivers revealed the causes of stress coalesced around 3 themes: (1) lack of preparedness to be a caregiver, (2) uniqueness of stress for the caregiver and patient situation, and (3) caregiving responsibilities physically and emotionally impacting caregivers. To cope with stress, most caregivers employed emotion-focused coping.ConclusionsIn family caregivers of patients with a left ventricular assist device, higher perceived stress was associated with lower caregiver preparedness, higher caregiver depressive symptoms, and lower patient quality of life. Emotion-focused coping strategies were common for caregivers. Future work should better prepare caregivers for this role and support them through the caregiving experience. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02344576.
| S-EPMC8559583 | biostudies-literature
Project description:Molecular analysis of the effect left ventricular assist device (LVAD) support has on congestive heart failure patients. Keywords = Congestive heart failure, left ventricular assist device, eNOS, gene, dimethylarginine dimethylaminohydrolase Keywords: other
2003-09-01 | GSE430 | GEO
Project description:BackgroundImplanting centers often require the identification of a dedicated caregiver before destination therapy left ventricular assist device (DT LVAD) implantation; however, the caregiver experience surrounding this difficult decision is relatively unexplored.Methods and resultsFrom October 2012 through July 2013, we conducted semistructured, in-depth interviews with caregivers of patients considering DT LVAD. Data were analyzed using a mixed inductive and deductive approach. We interviewed 17 caregivers: 10 caregivers of patients living with DT LVAD, 6 caregivers of patients who had died with DT LVAD, and 1 caregiver of a patient who had declined DT LVAD. The themes identified, which could also be considered dialectical tensions, are broadly interpreted under 3 domains mapping to decision context, process, and outcome: (1) the stark decision context, with tension between hope and reality; (2) the challenging decision process, with tension between wanting loved ones to live and wanting to respect loved ones' wishes; and (3) the downstream decision outcome, with tension between gratitude and burden.ConclusionsDecision-making surrounding DT LVAD should incorporate decision support for patients and caregivers. This should include a focus on caregiver burden and the predictable tensions that caregivers experience.
| S-EPMC4365422 | biostudies-literature
Project description:The increasing adoption of left ventricular assist devices (LVADs) into clinical practice is related to a combination of engineering advances in pump technology and improvements in understanding the appropriate clinical use of these devices in the management of patients with advanced heart failure. This review intends to assist the clinician in identifying candidates for LVAD implantation, to examine long-term outcomes and provide an overview of the common complications related to use of these devices.
| S-EPMC4824332 | biostudies-other
Project description:BackgroundAlthough left ventricular assist device (LVAD) implantation is associated with improved survival, long-term impact on functional class is less well understood in high-risk implants. We undertook this study to better understand how destination therapy (DT) LVAD implantation affects patient functional status and predictors of functional improvement.MethodsWe conducted a single-center, retrospective review of all primary LVAD implantations. Primary outcome was New York Heart Association (NYHA) functional class. An improved sustainable functional improvement was defined as being alive at 1-year with NYHA class I or II symptoms. Multivariable logistic regression was performed to identify predictors of sustainable functional improvement.ResultsFrom 2017 to 2023, 151 primary LVAD implantations were performed. Operative mortality was 7.95% (n=12). At 6-month follow-up, 113 (92.62%) of patients had experienced an improvement in functional class with 35 (28.69%) class I, 53 (43.44%) class II, 29 (23.77%) class III, and 5 (4.10%) class IV. At 12 months, 86 (91.49%) patients had sustained improvement in NYHA class with 32 (34.04%) class I, 40 (42.55%) class II, 19 (20.21%) class III, and 3 (3.19%) class IV. At 2 years, 57 (91.94%) patients still experienced improved symptoms. On multivariable logistic regression analysis, an ischemic etiology of heart failure (HF) was associated with a sustainable functional improvement [odds ratio: 5.53 (95% confidence interval: 1.06-28.89), P=0.04].ConclusionsLVAD implantation is associated with significant functional improvement as measured by NYHA class. The high-risk cohort showed similar improvement in functional status. In our series, the best predictor of a sustainable improvement in functional status is an ischemic etiology of HF.
| S-EPMC11494542 | biostudies-literature
Project description:ObjectiveTo assess the benefit of proactive palliative medicine consultation for delineation of goals of care and quality-of-life preferences before implantation of left ventricular assist devices as destination therapy (DT).Patients and methodsWe retrospectively reviewed the cases of patients who received DT between January 15, 2009, and January 1, 2010.ResultsOf 19 patients identified, 13 (68%) received proactive palliative medicine consultation. Median time of palliative medicine consultation was 1 day before DT implantation (range, 5 days before to 16 days after). Thirteen patients (68%) completed advance directives. The DT implantation team and families reported that preimplantation discussions and goals of care planning made postoperative care more clear and that adverse events were handled more effectively. Currently, palliative medicine involvement in patients receiving DT is viewed as routine by cardiac care specialists.ConclusionProactive palliative medicine consultation for patients being considered for or being treated with DT improves advance care planning and thus contributes to better overall care of these patients. Our experience highlights focused advance care planning, thorough exploration of goals of care, and expert symptom management and end-of-life care when appropriate.
| S-EPMC3104909 | biostudies-literature