The PARTNER-3 Continued Access Trial: TAVR in low-risk patients
Brigham and Women’s Hospital is one of two centers in New England currently participating in the PARTNER 3 Continued Access Trial that offers transcatheter aortic valve replacement (TAVR) to low-risk patients undergoing valve replacement for severe aortic stenosis.
“I have a lot of patients with severe aortic stenosis who are excellent candidates for TAVR, but they are in the low-risk category. I want to offer them TAVR, but I have to tell them they aren’t sick enough,” said Marc P. Pelletier, MD, Surgical Director of the TAVR Program. He joined the Heart & Vascular Center’s Structural Heart Team in 2016.
Ten patients have been enrolled into this low-risk TAVR registry. Members of the Structural Heart Team are contributing to the safety data for the continued access protocol. The original study results will be presented at the 2019 American College of Cardiology (ACC) meeting.
“We want to better understand whether TAVR is legitimate treatment option for healthy patients who have a long horizon of life and will ultimately outlast their valves,” said Pinak Bipin Shah, MD, Director of the Cardiac Catheterization Lab, where most TAVRs are performed at the Brigham.
A 2018 study in the American College of Cardiology assessed the safety and short-term efficacy of TAVR in 200 low-risk patients (mean age 74 years). Results showed that TAVR was associated with zero mortality and disabling stroke at 30 days. These low-risk patients also showed shorter lengths of hospital stay, lower rates of atrial fibrillation and paravalvular leak, and similar rates of requiring a permanent pacemaker.
“We are also evaluating durability in the continued access trial. We want to know how long TAVR valves last in this low-risk population. It might be a decade before we have definitive data on durability, but we’re excited to help answer this important question that will help expand the treatment to more patients,” said Dr. Shah.
EARLY TAVR trial: Early intervention in asymptomatic aortic stenosis patients
The Brigham is also participating in the EARLY TAVR (Evaluation of TAVR Compared to Surveillance for Patients with Asymptomatic Severe Aortic Stenosis) trial that is investigating early TAVR intervention on patients with severe aortic stenosis without symptoms.
“An emerging body of literature suggests that waiting until a patient is symptomatic can lead to irreversible changes in the heart, even when a patient may not be limited by aortic stenosis,” explained Dr. Shah.
The Structural Heart Team enrolled its first patient in the EARLY TAVR trial in April of 2018 and will continue to enroll patients for about 2-to-3 years. About 10 patients with asymptomatic severe aortic stenosis have received a TAVR at the Brigham as part of the EARLY TAVR trial.
Multidisciplinary, Multimodality, Minimalist (3M) Approach to TAVR
As more patients qualify for TAVR, many institutions face the challenge of moving patients through the system quickly and efficiently. How often can evaluations be offered? How many TAVRs can be performed in a day, a week? Can patients visit multiple providers—and receive all of their imaging and tests—in a single day?
The Brigham’s increasingly efficient TAVR program, which led to it becoming the first in New England to reach 1,000 TAVRs, resulted in its participation in the Multimodality, Minimalist (3M) Approach to TAVR. Sponsored by Edwards Lifesciences, the trial is examining the inner workings of Brigham’s TAVR Program, looking for operational efficiencies.
“We’ve built many efficiencies into our TAVR Program,” said Dr. Shah. “For example, we usually see patients within a week after referral. We also try to make sure patients see all of their specialists and get all of their testing in the same day. And we can usually treat patients within 2-to-3 weeks after their evaluation.”
Dr. Shah added that the Brigham has the infrastructure to perform TAVRs any day of the week, which maximizes access and has contributed to the high TAVR volume at BWH, while ensuring patients don’t have to wait too long in the hospital for their procedure.
“The goal of the 3M trial is to examine how our TAVR program is achieving its high volume with such speed and efficiency. It will allow us to improve our efficiency, while also serving as a model for other TAVR programs to potentially improve their volume and achieve better outcomes,” said Dr. Pelletier.