More than 200 million people worldwide experience peripheral artery disease (PAD). Peripheral artery disease (PAD) is a disease in which blood vessels from the heart to the legs become narrowed, causing pain when walking. Approximately 1 in 10 people have this. It progresses to chronic limb threatening ischemia (CLTI), a progressive form of PAD. CLTI patients often experience severe pain even when at rest, which is usually caused by a buildup of fatty plaque that blocks blood flow to the legs and feet. Patients with CLTI face an increased risk of amputation, cardiovascular disease, and early death, but research on the impact of this condition on quality of life remains limited.

Investigators from both Brigham and Women’s Hospital (BWH) and Massachusetts General Hospital (MGH), founding members of Massachusetts General Brigham and Boston Medical Center (BMC), sought to address this issue. Following previous research highlighting the clinical results of the BEST-CLI trial (Best Endovascular Therapy and Best Surgical Therapy for Patients with Critical Limb Ischemia), New England Journal of Medicine (NEJM), The research team assessed patients’ health-related quality of life before and after revascularization treatment.Results are posted below Circulation.

Matthew Menard, M.D., co-director of BWH’s endovascular surgery program and co-principal investigator of BEST, said, “Our study shows that patients with CLTI have a significantly lower quality of life compared to many other chronic conditions. “This shows that it is extremely low.” -CLI. “Our findings show that revascularization, which restores adequate blood flow to the legs, significantly improves quality of life. This confirms that it plays an important role in optimizing health.”

Patients with CLTI who are candidates for surgical treatment often have two options. One is a surgical bypass (bypass), where the surgeon restores blood and oxygen to the lower extremity by reconstructing a blocked blood vessel, or an endovascular procedure (endo), where a stent or stent is placed. A catheter is inserted into the artery and opened to allow blood flow to the blockage.

Funded by the National Heart, Lung, and Blood Institute and with ongoing post-enrollment support from the Novo Nordisk Foundation, the BEST-CLI trial included patients in the United States, Canada, Finland, Italy, and New Mexico. More than 1,800 CLTI patients from 150 study sites were enrolled. The researchers assessed how clinical outcomes (previously reported in NEJM) and quality of life indicators differed between revascularization procedures.

“Healthcare in general is moving toward a more patient-centered model of care, which means considering an evidence-based approach to what is best for each patient. “Quality of life is one of the key factors in this decision,” the co-directors said. Researcher Dr. Kenneth Rosenfield, MGH Division of Cardiology, Director of Vascular Medicine and Interventions.

The researchers divided the 1,528 participants into two cohorts. The first cohort consisted of her 1,193 patients, all of whom had available high-quality single-segment great saphenous veins (SSGSV). This has been shown in previous studies to be optimal for bypass. The second cohort consisted of her 335 patients who did not have her SSGSV ​​available. Patients in both cohorts were randomized to receive bypass or endo surgery. Researchers assessed quality of life by administering a self-administered survey that asked participants about pain levels, activities of daily living, disease symptoms and severity, physical activity, and mental health (anxiety and depression). did. Surveys were collected at baseline, 30 days, 3 months, and 12 months after treatment, and once a year thereafter until the end of the study.

“Patient-reported outcome measures are essential to understanding the patient experience,” said Co-Principal Investigator, Interim Chair of the Department of Surgery, Chair and Professor of Vascular and Endovascular Surgery at BMC. said Arik Farber, MD, MBA. He received his doctorate in surgery and radiology from Boston University Chobanian and Avedisyan School of Medicine. “However, these metrics are rarely used and sometimes ignored. Here we saw an opportunity to listen to the patient and use it to improve his CLTI outcomes. ”

Although clinical results from previously published trials showed that patients treated by bypass had fewer major amputations and less need for revision surgery than those treated with Endo, There was no significant difference in quality of life. Findings revealed that regardless of cohort and whether they received bypass or endo treatment, participants generally experienced significant improvements in their quality of life after treatment. They further highlighted that the vast majority of CLTI patients reported poor quality of life when they entered the study, prior to receiving treatment.

This study is limited in that patients completed quality of life questionnaires at separate periods during the study period, but these time points do not necessarily coincide with significant health events such as additional revascularization or amputation. There wasn’t. Furthermore, research on the quality of life of PAD patients is still lacking, and there are no specific indicators to assess the quality of life of PAD or CLTI patients.

Going forward, the team aims to assess the differences in cost-effectiveness of these procedures and how cost, among other factors, impacts patients’ quality of life and overall health. Masu.

“The next step is to integrate quality of life measures into more sophisticated care plans that consider the patient’s clinical condition and the cost-effectiveness of treatment options for both the patient and the health system’s viability. ,” Farber said.