TAVI registries showing greater success with experience, upgrades
As European clinics gain experience and new TAVI systems incorporate design improvements, the rates of procedure-related complications are sinking fast, according to registry data.
Researchers provided updates from the Source/Source XT, Prevail XT, and France 2 registries during the TCT conference, TCT Daily reported.
Dr. Martyn Thomas of St. Thomas’ Hospital in London announced that major complications associated with TAVI had gone down between the Source studies of Edwards Lifesciences’ (NYSE:EW) Sapien device and the Source XT studies of the Sapien XT device, which features a cobalt-chromium frame and additional valve sizing.
The cobalt-chromium frame gives the Sapien XT system a lower profile, allowing for delivery via a smaller catheter, spokeswoman Sarah Huoh told MassDevice.com in an email. The Sapien XT is also more similar in design to Edwards’ surgical valves.
30-day all-cause mortality in the Source trial was 9.6% and cardiac mortality was 4%, but in the Source XT trials all-cause mortality sank to 6.3% and cardiac mortality was 2.6%.
"I’m glad to say that the incidence of [procedural] complications is now extremely low," Thomas said, adding that physicians have also learned to better handle major issues, leading to sinking rates of death from major bleeding and vascular complications.
In the France 2 registry evaluating Edwards’ Sapien device and Medtronic’s (NYSE:MDT) CoreValve TAVI system, the devices showed similar rates of vascular complications and stroke, according to Dr. Hélène Eltchaninoff of the University of Rouen in France, who presented the data.
That registry included nearly 4,000 patients, 67% of which received Sapien and 33% received CoreValve, according to TCT Daily. Nearly
The major difference between the devices was the need for post-TAVI pacemaker implantation, with 24% of CoreValve patients needing a pacemaker compared with only 11.8% of Sapien patients.
However, that so-called "pacemaker issue" may be on the decline. Physicians have come up with a handful of strategies that may reduce the need for patients to receive pacemakers alongside heart valves, and the rate of post-CoreValve pacemaker implantation has come down in recent years.
TAVI continues to look good, but there’s room for improvement
Studies of transcatheter aortic valve implantation continue to affirm that the technology beats medical management for certain patients, but procedural aspects of patient treatment still have some room to grow, researchers said.
New imaging and sizing advances as well as new TAVI access routes are on the way, Dr. Eberhard Grube of the University Bonn in Germany told TCT 2012 attendees.
The field could also use some news guidelines, TCT course director from Colombia University Medical Center Dr. Martin Leon noted. Researchers should focus efforts on developing a dedicated TAVI risk score, preferred access, procedural details and other elements that could help physicians reduce complications associated with treatment.
Concerns about the transapical approach
Researchers expressed concern about the potential for valve leakage following TAVI specifically via the transapical approach, which involves access via an incision under the left breast, directly below the heart.
Researcher Leif Thuesen presented the results of the Danish Staccato trial, which was cut short prematurely after enrolling 70 patients and noting several adverse events over a 12-month period.
Safety monitors recommended halting the trial following reports of strokes, renal failure and patient deaths, but the main issue was paravalvular leakage, according to Thuesen. More than 40% of patients had minor leakage and 13% had moderate or severe leakage, TCT Daily reported.