Transcatheter Valve-in-valve Procedure Improves Short-term Outcomes In High-risk Patients

"These results propose that a transcatheter valve-in-valve process whitethorn connection an important short-term objective use successful selected high-risk patients," said main interrogator Dimytri Siqueira, MD, PhD, main of interventions successful nan Acquired Valvular Heart Disease conception astatine nan Dante Pazzanese Institute of Cardiology successful Sao Paulo. "However, semipermanent follow-up of diligent outcomes is basal to amended understand durability and nan wide domiciled of this attack successful objective practice."

The mitral valve, 1 of 4 valves successful nan heart, controls humor travel from nan near atrium (the heart's upper-left chamber) to nan near ventricle (the heart's main pumping chamber). It consists of 2 flaps of tissue, aliases leaflets, that unfastened to let humor travel and adjacent pinch each heartbeat. Severe mitral valve illness tin lead to bosom failure, precocious humor unit successful nan lungs and an elevated consequence for humor clots and stroke. Women are much apt than men to create mitral valve disease.

The modular curen for terrible mitral valve illness is open-heart room to either repair aliases switch nan mitral valve pinch a prosthetic valve. If replacement is required, astir patients now take to get a prosthetic valve made of animal insubstantial alternatively than 1 made of metal, Siqueira said, to debar having to return lifelong blood-thinning medicine to forestall humor clots from forming connected aliases adjacent a metallic valve. Over time, however, valves made of animal insubstantial (derived from pigs aliases cows, known arsenic bioprosthetic valves) deteriorate and request to beryllium replaced. Siqueira estimated that up to 30% of patients request to person a repetition mitral valve replacement aft astir 10 years, astatine which constituent they are older and whitethorn person different wellness problems that make open-heart room riskier. Studies person shown that astir 7% of patients tin dice of complications from these "redo" surgeries, compared pinch little than 1% who dice aft a first mitral valve replacement surgery.

Transcatheter mitral valve-in-valve (mVIV) has emerged arsenic a minimally invasive replacement to redo mitral valve replacement room (rMVR) successful patients who cannot acquisition repetition open-heart surgery. The mVIV process involves utilizing a agelong elastic conduit called a catheter to spot a caller prosthetic valve wrong nan patient's poorly functioning one. Until now, however, nan outcomes of mVIV and rMVR had not been compared successful a randomized, controlled trial, Siqueira said.

The investigator-initiated SURVIV proceedings enrolled 150 patients (average property 58, 72% women) astatine 7 centers successful Brazil. Many participants had underlying rheumatic valve disease, a communal origin of mitral valve illness successful middle- and low-income countries, which often leads to valve replacement astatine a younger property and increases nan likelihood of consequent interventions.

In nan United States, nan mean property for a first mitral valve room is astir 64 years old, and galore patients whitethorn request a repetition room successful their 70s aliases 80s. By contrast, successful Brazil, wherever rheumatic valvular bosom illness is still common, patients often acquisition their first mitral valve room successful their 30s aliases 40s and request a 2nd replacement valve room 10 to 15 years later, Siqueira said.

All patients were considered suitable candidates for some repetition open-heart room and nan mVIV procedure. Seventy percent had precocious humor unit successful their lungs, while 50% had atrial fibrillation, a rapid, irregular heartbeat that elevates consequence for humor clots, changeable and bosom failure. About a 4th had already undergone much than 1 anterior mitral valve surgery.

Patients were randomly assigned to person a caller mitral valve via either mVIV aliases rMVR. The study's superior endpoint was a composite of decease from immoderate origin and disabling changeable astatine 1 year. Key secondary endpoints included awesome complications specified arsenic decease from bosom illness aliases a stroke, awesome bleeding and kidney failure.

At 1 year, nan superior endpoint occurred successful 20.8% of patients assigned to rMVR and successful 5.3% of those treated pinch mVIV. This quality was mostly driven by events occurring successful nan early postoperative period, Siquiera said. In-hospital deaths were higher successful nan surgical group (12.5% vs. 0%), reflecting nan greater invasiveness of redo room successful this population, he said. Acute kidney wounded and life-threatening aliases awesome bleeding complications were besides much often observed aft surgery, while changeable rates were debased successful some groups.

The study has respective limitations, including its comparatively mini size and that it was performed successful a azygous country—making it little generalizable to populations pinch different objective characteristics, wellness attraction systems aliases underlying causes of mitral valve disease. In addition, galore participants had precocious mitral valve dysfunction related to rheumatic bosom disease, and pulmonary hypertension was common—factors that whitethorn summation surgical risk. It was besides not imaginable to unsighted patients and their physicians to which process patients were receiving, though members of an independent master committee that adjudicated diligent outcomes were blinded. Finally, nary information are disposable connected semipermanent diligent outcomes aliases valve durability for patients treated pinch mVIV versus modular surgery. The researchers scheme to travel nan patients successful nan study for a full of 10 years to effort to reply these questions.

SURVIV was an investigator-initiated study funded by nan Dante Pazzanese Institute of Cardiology, pinch further support from Edwards Lifesciences, which manufactures (and donated) nan transcatheter valves utilized successful nan study.

Siqueira will coming nan study, "Redo-Surgery Versus Transcatheter Valve-In-Valve for Mitral Bioprosthetic Dysfunction: The SURVIV Trial," connected Sunday, March 29, astatine 4:00 p.m. CT / 21:00 UTC in the Main Tent, Great Hall.