The short-term results of minimally invasive transcatheter valve-in-valve implantation to treat failed biological heart valve protheses are "excellent," but patients must be closely monitored due to some notable cases of suboptimal systolic-valve performance, according to early data from a multi-center trial.
In findings presented last week at the American Assn. for Thoracic Surgery’s annual meeting in Minneapolis researchers reported on 45 transcatheter aortic-valve cases performed at 11 medical centers in Finland, Sweden, Norway, and Denmark between May 2008 and January 2012.
"Early experience of valve-in-valve implantation is excellent," Dr. Leo Ihlberg of the Heart & Lung Center of Helsinki University Hospital, Finland, said in a statement, according to heartwire. "A subset of patients are left with high transvalvular gradients with unknown long-term effects, so long-term surveillance after implantation is mandatory."
Complications and procedure-related incidents were relatively low in patients followed for an average of 14 months. There were no intra-procedural deaths and the technical success rate was 95.6%, with 1 second valve implantation and 1 conversion to open surgery, Ihlberg reported.
The trial focused on high-risk patients with an average age of 80.6, according to researchers. Of the 45 patients studied, 26 of were male, and all patients were in NYHA class 3 or 4.
The mean duration of time from surgery to patients’ valve failure was 9 years, and the main mode of failure, in 51%, was stenosis, followed by regurgitation in 29%.
Major complications occurring within 30 days included stroke in 2.2% of patients, periprocedural heart attack in 4.4%, and major vascular complication in 2.2% of patients.
After 1 month, all patients, with 1 exception, had either no paravalvular leaks in the valves or mild ones.
The trend of using biological aortic valves, which are known for limited lifespans, in younger patients may give rise to a generation of recipients in need of replacement, increasing demand for technology like valve-in-valve implantation, Ihlberg noted.
Dr. Mathew Williams of Heart Valve Center at New York-Presbyterian Hospital/Columbia University Medical Center in New York, pointed to a promising future for the valve-in-valve approach based on the study data.
"I think this is an exciting procedure that really represents a sweet spot for transcatheter-valve implantation," he said. "This is an observational study, and the data were well presented. Fortunately, now a lot more of us are able to do this procedure."
Williams noted that initial reports recommended getting to the failed biological valve via the transapical-access approach, which was was used in about half of patients in the study, but Ihlberg suggested making decisions on case-by-case basis.
"I would say the access is up to the discretion and preference of the operator and partly the devices used in the center," Ihlberg said. "I still like the surgical short access and the idea of landing the device exactly on the target – I like to think of it as landing a helicopter on an aircraft carrier."