News | Structural Heart | January 25, 2017

Heart Surgery Excellent Option for Elderly Patients with Aortic Stenosis

Sub-analysis of PARTNER-IIA trial finds mortality for surgical aortic valve replacement non-inferior to TAVR

SAVR, surgical aortic valve replacement, elderly patients, aortic stenosis, Society of Thoracic Surgeons, clinical study

January 25, 2017 — Elderly patients with aortic stenosis (AS) and medium surgical risk experienced better than expected results after undergoing traditional surgical aortic valve replacement (SAVR), according to research presented at the 53rd Annual Meeting of The Society of Thoracic Surgeons.

“In an era that includes both SAVR and transcatheter aortic valve replacement (TAVR), it is clear that the treatment for aortic stenosis has changed,” said Vinod H. Thourani, M.D., from Emory University in Atlanta, who led the study. “But even with the availability of the relatively new TAVR procedure, SAVR remains a safe and effective way to treat aortic stenosis in intermediate-risk, elderly patients.”

Thourani and colleagues from 15 other institutions performed an in-depth analysis of SAVR outcomes in patients who participated in the Placement of Aortic Transcatheter Valves (PARTNER-IIA) trial. In the PARTNER-IIA trial, conducted from December 2011 to November 2013, 1,011 severe aortic stenosis, intermediate-risk patients were randomized in 57 North American centers to SAVR. Of these, 937 patients had surgical valve implantation and ultimately composed the study group for this research. The mean age was 82 years old, and 55 percent were male.

In their analyses, researchers found that the operative mortality was 4.1 percent, somewhat lower than the STS predicted risk models — a tool for surgeons to predict the patient risk of death or illness following open aortic valve replacement. “The outcomes in intermediate-risk patients who received SAVR were excellent, showing that mortality is non-inferior to TAVR,” said Thourani. “This was better than expected.”

According to Thourani, approximately 15 percent of all patients undergoing SAVR in the United States are intermediate-risk. SAVR is the replacement of the aortic valve, the main valve separating the heart from the rest of the body, through an incision in the chest. During this procedure, the patient is placed on the heart-lung machine while the aorta (main blood vessel of the body) is opened and the defective valve is replaced with an artificial valve.

TAVR was approved in the United States in late 2011, providing an alternative therapy for high-risk patients with AS who previously were refused SAVR. Prior to TAVR, SAVR was the only effective long-term therapeutic option for patients.

In addition to a lower than expected mortality rate from SAVR, researchers were surprised to learn that prosthesis-patient mismatch was common, with 33 percent of patients receiving a surgical valve that was too small. However, according to Thourani, this did not affect the mortality. The study also showed a greater risk of in-hospital stroke among SAVR. “In the past, there were no formal neurological assessments, meaning that previous rates possibly were understated,” explained Thourani. “The PARTNER-IIA study was one of the first times that neurological evaluations following the SAVR procedure were conducted, so further research in this area is required.”

AS is the most common acquired valve disease in elderly patients and affects nearly 3 percent of those over the age of 75, according to the American Heart Association. The ability to safely treat AS has become increasingly important; the US Census Bureau reports that the elderly population in the United States is projected to almost double, from the most current estimate of 43 million in 2012 to 80 million by the year 2050.

“Patients with aortic stenosis must realize how important it is that they are evaluated by a dedicated heart valve team that can help them understand the variety of options available and shepherd them into the most informed decision,” said Thourani.

Future research includes a randomized PARTNER-III study that will evaluate TAVR and SAVR in low-risk patients.

The Partner IIa Trial was presented as a late-breaking study at the 2016 Amerucabn College of Cardiology (ACC). Read the article “Sapien 3 Outperforms Surgery in ACC.16 Late-breaker.”

Watch a video disciussion with Thourani on this trial at ACC.16.

The trial also helped expand the current FDA indications for the Sapien Valve. Read the article “FDA Expands Sapien TAVR Valve Indication to Intermediate-Risk Patients.”

The other authors of the study were Wilson Szeto, M.D., Susheel Kodali, M.D., Eugene Blackstone, M.D., Ashley Lowry, M.D., Raj Makkar, M.D., Mathew Williams, M.D., Joseph Bavaria, M.D., Howard Herrmann, M.D., Hersh Maniar, M.D., Vasilis Babaliaros, M.D., Craig Smith, M.D., Alfredo Trento, M.D., Paul Corso, M.D., Augusto Pichard, M.D., D. Craig Miller, M.D., Lars Svensson, M.D., Samir Kapadia, M.D., Gorav Ailawadi, M.D., Rakesh Suri, M.D., Kevin Greason, M.D., Rebecca Hahn, M.D., Wael Jaber, M.D., Jessica Forcillo, M.D., Maria Alu, M.D., Martin Leon, M.D., and Michael Mack, M.D.

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