TAVR Feasible for Inoperable Patients with Severe Regurgitation Alone

Transcatheter aortic valve replacement (TAVR) may be a safe and effective treatment for patients with severe native aortic valve regurgitation (NAR) but no stenosis who are not candidates for surgery, according to an analysis of a worldwide registry of 43 patients at 14 centers.

All patients underwent TAVR with the CoreValve prosthesis (Medtronic) after having been diagnosed with severe NAR. None had aortic stenosis but 17 had annular calcification documented by CT or transoesophageal echocardiography.

According to lead investigator David Roy, MD, of St. George’s Hospital in London, United Kingdom, implantation of a transcatheter valve was performed   in 97.7% of patients, although 8 patients (18.6%) needed a second valve during the index procedure due to residual regurgitation. There was no annular calcification in each of those 8 patients (p=0.014). A transfemoral approach was used in 35 patients, a subclavian approach in 4, direct aortic in 3 and right carotid approach in  1 patient .

Patients’ mean age was 75.3 years and 53% were women. The prevalence of severe comorbidities at the time of the procedure was high, with a mean logistic EuroSCORE of 26.9±17.9%, and Society of Thoracic Surgeons score of 10.2±5.3%.

Grade 1 or less regurgitation was present post procedure in 34 patients, grade 2 in 7 patients, and grade 3 in 2 patients. At 30 days, the incidence of all-cause mortality was 9.3% (4 patients, with 1 death due to cardiovascular mortality). The rate of major stroke was 4.7% at 30 days , and there were no MIs according to Valve Academic Research Consortium criteria. At 12 months, all-cause mortality was 21.4%, with 3 deaths attributed to cardiovascular mortality.

A challenging new indication for TAVR

“TAVR for aortic regurgitation is an exciting new indication for this technology that requires different techniques and anatomical variables to implant a functioning prosthesis in the anatomical position,” Roy said. “While there is a slightly higher incidence of needing a second valve to achieve an acceptable result with current technology, new-generation retrievable valves will be ideal for this indication.”

Roy noted that TAVR has gained acceptance among interventional cardiologists as a treatment for high-risk surgical patients with severe aortic stenosis. Many interventionalists believe that it may someday replace conventional surgical aortic valve replacement as the technology continues to improve, he added.

Even though there is published evidence from randomized, controlled trials and registries that TAVR is an acceptable treatment for such patients, no evidence has been published regarding its use for pure NAR, he said. The only two TAVR valves on the market, CoreValve and the Sapien device (Edwards Lifesciences), are approved for treatment of aortic stenosis, making TAVR for NAR an off-label use.

“The findings show that TAVR may be an  acceptable treatment for selected patients with NAR who are deemed inoperable or [at] extreme surgical risk, with promising procedural and clinical outcomes in this high risk subset of patients,” Roy told TCT Daily.

Disclosures:

Dr. Roy reports no relevant conflicts of interest.