ACC17: Noninvasive intervention for open heart surgery candidates performs well in clinical trial
There were no significant differences in rates of all-cause mortality or disabling stroke after two years between patients treated with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR), according research published by the New England Journal of Medicine.
The Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial tracked outcomes for 864 patients treated with TAVR and 796 who underwent surgery.
- Patients in the TAVR group generally experienced better results in the first 30 days following treatment, including lower rates of stroke, lower rates of new onset atrial fibrillation and lower rates of acute kidney injury.
Patients at intermediate- or high-risk for open surgery have what seems to be a safe alternative available to them. All-cause mortality rate in the TAVR group was 11.4% versus 11.6% in the SAVR group and disabling stroke rate was 12.6% in the TAVR group versus 14% in the SAVR group.
Aortic stenosis is a common condition that restricts blood flow through the heart and is most likely to develop due to damage caused while aging by calcium or scarring. Patients with severe cases of aortic stenosis have traditionally required open heart surgery to replace the aortic valve. However, TAVR uses a catheter to implant a replacement valve. The intervention offers similar outcomes to surgery over two years and some immediate benefits.
“Near-term results showed critical insights for the therapy,” principal investigator Dr. Michael Reardon said in a statement. “In the first 30 days, patients treated with TAVR experienced statistically lower rates of stroke, lower rates of new onset atrial fibrillation, a quicker hospital discharge, less acute kidney injury and transfusions, and an improved quality of life.”
TAVR also appears to be cost-effective. TAVR costs are approximately $11,260 more per patient than SAVR costs, according to a study published January 2016 by the Journal of the American College of Radiology. However, researchers determined that quality-of-life improvements experienced by TAVR patients showed significant value to the increased costs.
- The New England Journal of Medicine Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients
- Journal of the American College of Cardiology Cost-Effectiveness of Transcatheter Aortic Valve Replacement With a Self-Expanding Prosthesis Versus Surgical Aortic Valve Replacement
- Medtronic Landmark SURTAVI Clinical Trial Shows Transcatheter Aortic Valve Replacement (TAVR) with the Self-Expanding Platform Performs as Well as Surgery in Intermediate Risk Severe Aortic Stenosis Patients