Elderly patients enjoy improvements in quality of life and functional outcomes similar to those experienced by younger patients after left ventricular assist device (LVAD) implantation, but with fewer late major complications, new registry data show.
"When you talk about who is impacted by end-stage heart failure, it's hundreds of thousands of patients, of which the majority are elderly, and when you look at the number of LVADs implanted, it's in the thousands. So clearly there is a huge population of patients that is underserved," study author Joanna Chikwe, MD, told theheart.org | Medscape Cardiology. "Hopefully, this research brings this to the forefront as an option for those patients."
Although current consensus guidelines recommend LVADs as a bridge to transplantation or destination therapy for patients with stage D heart failure (HF), the risk for major complications, such as pump thrombosis, stroke, bleeding, and infection, has been a barrier.
Newer materials technology and engineering, including fully magnetic levitation devices, however, have reduced thrombogenicity and the requirement for aggressive anticoagulation and provide a greater barrier to sepsis, observed Chikwe, from the Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles. Current-generation LVADs are also significantly smaller than older models, so the surgery involved in implantation is less morbid.
To better understand contemporary outcomes, the investigators, led by James Kirklin, MD, University of Alabama at Birmingham, and colleagues analyzed national data from 24,408 adults (78% male, 66% White) who received durable LVADs from January 2010 to March 2020 in the Society of Thoracic Surgeons (STS) Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) database.
As reported in the August 31 issue of the Journal of the American College of Cardiology, 51% of devices were placed as destination therapy, 22% as a bridge to transplant, and 27% as a bridge to candidacy.
Most patients (68.9%) were younger than 65 years, 26.3% were 65 to 75 years of age, and 4.8% were older than 75 years.
In a competing risk analysis, mortality on LVAD support at 5 years was 33.5% in patients younger than 65 years, 54.4% in those 65 to 75 years, and 66.2% for the elderly cohort older than 75 years.
Notably, 3-year survival in the elderly cohort improved significantly over the decade — up from 43.0% in 2010 to 2012, to 46.3% in 2013 to 2016, and 55.7% in 2017 to 2020 (P = .004).
Rates of late stroke, device malfunction or thrombosis, infection, and rehospitalization were lowest in the oldest cohort and highest in the youngest cohort (P < .01 for all comparisons except infection, where the 65- to 75-year age group and the older than 75-year age group were not statistically different).
"We were very surprised by that and I think there are a few potential explanations, one of which is that older patients were much more cautiously selected than younger patients. You might be implanting LVADs in much sicker younger patients," she said.
In fact, younger patients were more likely than older patients to present in cardiogenic shock, to have a left ventricular ejection fraction below 20%, and to have comorbid major stroke and pulmonary hypertension.
In contrast, bleeding rates were lowest among patients younger than 65 years and highest among those 65 to 75 years (P < .05 for both).
Independent predictors of late mortality were major psychiatric illness, limited social support, and frailty.
Interestingly, patients older than 65 years receiving newer-generation full magnetic levitation devices had significantly better late survival on support than those receiving older LVAD models (hazard ratio, 0.35; 95% CI, 0.25 - 0.49).
These data support the hypothesis that the elderly might derive sustained benefit from the new smaller, more hemocompatible LVAD models because they're less able to tolerate physiologic insults than younger patients and, "consequently, device-related complications, particularly bleeding and thrombosis, may be more likely to result in hospital admission, major morbidity, and mortality," the authors write.
Asked which newer-generation models could be particularly beneficial, Chikwe replied: "HeartMate 3 is the main winner in this…. It’s doing the heavy lifting."
In an accompanying editorial, Francis Pagani, MD, University of Michigan, Ann Arbor, agreed that pump thrombosis and stroke are likely more devastating to elderly patients and "that reduction of these particular complications and improvement in hemocapatibility of the HeartMate 3 device likely has greatest benefit in the elderly population."
One of the key take-home messages from the study is that patients have better quality of life and functional capacity after LVAD implantation, Chikwe noted.
Quality-of-life scores on the EQ-5D questionnaire improved from a median of 40 preoperatively to a median of 75 at 1 year (P < .001), with all age groups seeing a median increase of 30 points at 1 year.
"A shift of about 15 or 20 points on the scales is significant and important for an individual and we were seeing much bigger shifts with LVAD implantation and that's not driven by the fact that you're taking people with the worst quality of life and improving it slightly; that was seen across the whole population," she said.
Despite limited mobility in most patients prior to implant, median 6-minute walk distance also increased from 0 to 1065 feet among 4321 patients with preoperative and 1-year data. The change was greatest in the younger cohorts, but those older than 75 still upped their game by a median of 456 feet.
"These attributes of the therapy are key essentials, particularly in the elderly who do not have transplantation as an alternative or 'bail out' strategy if quality of life were not to improve," writes Pagani.
"Although living longer is an important goal of any advanced therapy, living well has equally profound implications," he observed.
Pagani pointed out that the proportion of patients in the STS Intermacs database receiving durable LVADs jumped from 49.5% in 2017 to 78.1% by 2020, reflecting shifting priorities in the 2018 transplant allocation system in the United States, which delegated durable LVADs largely to those ineligible for heart transplantation.
Yet the number of durable LVAD recipients older than 75 years was only 280 from 2010 to 2012 and 425 from 2017 to 2020.
"As noted by the authors, these observations correctly suggest that durable LVAD therapy is likely underutilized in the elderly population," he said.
The study was funded and designed by the Society of Thoracic Surgeons (STS). Senior author James K. Kirklin, MD, reports partial salary support, paid to his institution, from the STS. All other authors report having no relevant relationships to disclose. Pagani has served on the scientific advisory board of FineHeart.
Medscape Medical News © 2021
Cite this: Elderly HF Patients Reap Big Benefits, but Miss Out on LVADs - Medscape - Aug 25, 2021.