Percutaneous Paravalvular Leak Closure in Failed Surgical Valves Feasible

In patients with a failed surgical valve replacement, percutaneous closure of paravalvular leak is associated with high procedural success and offers outcomes comparable to surgery, according to registry data presented during a Featured Clinical Research session at TCT 2015.

Paravalvular leak occurs in 5% to 17% of mitral valve replacement patients and 5% to 10% of aortic valve replacement patients, including both TAVR and annuloplasty. “Repeat surgery is a high-risk strategy, with 30-day mortality in the range of 8% to 12%,” said Patrick Calvert, BMBCh, MRCP, PhD, of Queen Elizabeth Hospital, Birmingham, United Kingdom. Previous research on percutaneous closure, he noted, has been limited to small, single-center studies.

The retrospective registry of British and Irish patients treated between 2004 and 2015 included 308 paravalvular leak closures in 259 patients from 20 centers.

Favorable results

The rate of procedural success was 91%, with 19% requiring repeated
attempts. Most procedures were elective (80.9%), and fewer were urgent (17.6%) or emergent (1.6%). The target valve in most procedures was either the mitral (44.4%) or the aortic valve (47.5%).

Calvert reported that death and MACE rates over a median follow-up of 110 days (primary endpoint) compared favorably with surgery (Table).

Several factors were independently associated with death. These included paravalvular leak at follow-up (P = .037), NYHA class at follow-up (P = .015) and baseline creatinine level (P = .001). Leak at follow-up was also independently associated with MACE (P = .002).

At baseline, 61% of patients had severe paravalvular leak while 34% had moderate leak. Following the procedure, severe leak persisted in 6.7%, moderate leak in 18.6%, mild leak in 41.3%, and no leak in 33.3%. Those with no or mild leak after the procedure had significantly better cumulative survival than those with moderate or severe leak (P = .032). The same was true of cumulative survival free from MACE (P < .001).

“Percutaneous device closure is feasible, with results comparing favorably to surgery,” Calvert noted. “Critically, achieving a leak of mild or less was associated with less death and less MACE.”

According to Calvert, oblong devices including the Amplatzer Vascular Plug III (St. Jude Medical) and the Occlutech PLD (Occlutech), which were used in 68% and 3.9% of the cases in the registry, respectively, were associated with nonsignificant trends for less leak at follow-up and better functional results. He called this finding regarding the devices “hypothesis-generating.” Neither device is currently approved by the FDA, but both are CE marked.

Disclosures:

• Calvert reports receiving consultant/honoraria fees from AstraZeneca, has been a proctor for St. Jude Medical and has received travel and accommodations from Biosensors and St. Jude Medical.