"We were surprised by the substantial improvements in quality of life and physical activity experienced by patients of all ages, particularly the most elderly, who also seemed to experience fewer bleeding complications, infections and strokes compared to younger patients," Dr. Joanna Chikwe of Cedars-Sinai Medical Center in Los Angeles told Reuters Health by email. "Although this confirms our own clinical experience with new-generation devices, we were impressed to see similar results reproduced throughout the U.S."
"The most surprising finding was that older patients had fewer strokes, infections and major bleeding complications compared to younger patients," she said. "We believe this reflects a much more cautious approach to selecting older patients for this therapy compared to young patients, the majority of whom received LVADs because major illness and other risk factors disqualified them from heart transplantation."
"However," she added, "it is important to recognize that almost half of the elderly patients in our study were dependent on inotropes or temporary mechanical circulatory support before LVAD implant, so were still high-risk."
As reported in the Journal of the American College of Cardiology, Dr. Chikwe and colleagues analyzed data from the Interagency Registry for Mechanically Assisted Circulatory Support database. The primary outcome was adjusted survival. Secondary outcomes included quality of life; 6-minute walk distance; stroke; device malfunction; and rehospitalization, stratified by patient age.
The median follow-up was 15 months.
The cohort (78% men; 51% on destination therapy) included 16,808 patients (68.9%) ages <65; 6,418 (26.3%) ages 65-75; and 1,182 (4.8%) >75.
Competing outcomes analysis demonstrated 34% mortality for those <65; 54% for those 65-75; and 66% for those >75.
Newer-generation devices were associated with reduced late mortality (hazard ratio, 0.35).
Stroke, device malfunction or thrombosis, and rehospitalizations decreased with increasing age. However, those over 75 tended to experience fewer AEs than those ages 65-75 - for example, 8.7 gastrointestinal bleeding events per 100 patient-months versus 9.3; 2.2 versus 2.5 strokes; and 19.1 versus 20.2 rehospitalizations.
Overall, the median 6-minute walk distance increased from 0 feet to 1,065 feet and quality of life measured by a visual analog scale (0, worst health; 100 best health) improved from 40 to 75.
Dr. Chikwe said, "We believe these findings are potentially practice-changing. The majority of the six million patients with heart failure in the US are elderly, but each year only one hundred or so patients aged >75 years received this transformative therapy in our national study."
"We believe this is because most clinicians are unaware that major strides in device technology and therapeutics have driven huge improvements in quality of life and physical activity that could benefit patients who are too elderly to qualify for heart transplants," she said.
That said, she added, "LVAD therapy is expensive and requires long-term specialist follow-up, so cost may become a barrier to supporting the growing population of elderly patients with advanced heart failure with this therapy."
Dr. Francis Pagani of the University of Michigan, author of a related editorial, commented in an email to Reuters Health, "LVAD therapy represents a viable option for selected elderly patients with advanced heart failure. Based upon the number of patients included in the study compared to the number of likely elderly patients with advanced heart failure, it is likely that LVAD therapy is underutilized as a treatment option."
Like Dr. Chikwe, he noted, "Elderly patients actually experienced fewer adverse events with LVAD therapy compared to younger patients. Newer LVAD pumps that have recently been introduced have shown greater benefit in the elderly relative to the benefit observed in younger patients."
SOURCE: https://bit.ly/3z12pix and https://bit.ly/38UzrWU Journal of the American College of Cardiology, online August 23, 2021.
By Marilynn Larkin
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