LISBON, Portugal — An off-pump surgical procedure designed to restore the failing heart to normal morphology improves left ventricular end-systolic volumes (LVESV) and end-diastolic volumes (LVEDV) in chronic heart failure patients at six months and one year, according to the results of a small phase 1 study.
The surgery, which utilizes titanium anchors (Revivent, BioVentrix) to pull and exclude scarred and acontractile myocardium from the ventricular chamber, also resulted in improvements in the six-minute-walk test, NYHA class, and quality of life at six and 12 months, report investigators.
The study, known as CONFIGURE-HF , was presented this week during the late-breaking clinical-trials session at Heart Failure Congress 2013 , a meeting of the European Society of Cardiology Heart Failure Association, by Dr John Teerlink (University of California, San Francisco). "The idea is that we have made tremendous advances in the treatment of heart failure with all of the agents that we have," Teerlink told heartwire , "but we still have these patients who have these huge hearts that have been so scarred and so damaged that no amount of drug is going to help them. So the question has always been is there something we can do for those hearts that will help those patients."
Attempting to Improve Where STICH Failed
This was also the concept behind the Surgical Treatment for Ischemic Heart Failure (STICH) trial, a study that investigated the benefits of surgical ventricular reduction (SVR). That study, which was incredibly slow in enrolling patients, was ultimately negative. Even though heart surgery with SVR reduced end-systolic volume index (ESVI)--the volume of the left ventricle indexed to the patient's size--more than CABG alone, this made no difference in angina, heart-failure symptoms, the six-minute-walk test, or clinical outcomes, including death and hospitalization.
Still, Teerlink said the concept of ventricular reduction has not been abandoned, because there remain questions about whether the SVR technique used in STICH was effective enough in reducing ventricular volumes. In CONFIGURE-HF, the surgical reconstruction is reserved for patients with myocardial scarring in the anteroseptal region, as well as in the apex of the heart. Surgeons place an anchor in the right ventricle, along the septal juncture, and a second anchor at the external end of the myocardial scar. The two anchors are drawn together in order to plicate the scar tissue.
"What this effectively does, because of the way it is aligned along the heart's axis, is reestablish to some degree the normal ellipsoid geometry of the heart, as well as reduce volumes and wall stress, all of which we think are related to longer-term improvements in outcomes," said Teerlink.
Just 26 patients were enrolled in the study. All were on optimal medical therapy and had an ejection fraction of 28% at baseline. The patients were equally split among those with NYHA class 2 and class 3 heart failure. Despite the six-month and 12-month improvements in LVESV, LVEDV, and other heart-failure–related end points, Teerlink said it is still early in the game with the procedure and urged caution in interpreting echocardiographic end points. Dr Marco Metra (University of Brescia, Italy), the scheduled discussant during the session, also warned against overinterpreting the results, especially the subjective measures, given that the trial was unblinded.
However, Teerlink and Metra expressed some optimism in terms of the reduction percentage LVESV following surgical reconstruction. In STICH, the reduction percentage following SVR was 19%, whereas the percentage was 33% in CONFIGURE-HF, which suggests a better and more consistent result with the procedure. But, as Teerlink noted, the numbers are small and patients might be highly selected in CONFIGURE-HF, so future studies will determine whether this procedure gains any traction.
Heartwire from Medscape © 2013 Medscape, LLC
Cite this: Ventricular Reshaping Surgery Rises Again in Heart Failure: CONFIGURE-HF Phase 1 Results - Medscape - May 29, 2013.