A study in Circulation: Cardiovascular Interventions found that 30-day readmission rates for transaortic valve replacement (TAVR) procedures and traditional surgical aortic valve replacement (SAVR) were similar, in spite of growing momentum for the minimally invasive TAVR treatment paradigm.
The readmission rates were around 20% for all patients, including those 80 or older, those with congestive heart failure and those who had a TAVR implanted via the transfemoral (through the veins in the leg) approach.
The study was based on data of 617 severe aortic stenosis patients who received TAVR via a delivery catheter and 1,981 patients who had their implant installed using open heart surgery. The registry data is from New York's Cardiac Surgery Reporting System, and was collected between January 2011 and November 2012.
Heart failure was the most common reason for readmission, accounting for 21.9% of readmissions in the TAVR group and 19.2% in the SAVR group. Other reasons for readmission after TAVR included postoperative infection (responsible for 11% of readmissions), hemorrhage or hematoma (5.5%), stroke or transient ischemic attack (4.1%), and respiratory failure (4.1%). For the surgical group, the reasons included cardiac rhythm disorders (responsible for 9.6% of readmissions), stroke or transient ischemic attack (5.5%), pneumonia (5.5%), pneumothorax/pleural effusion (5.5%), and GI bleeding (5.5%), reports cardiology news source TCTMD in a summary of the study.
Median total length of stay, including any readmissions, was 9 days for patients receiving a TAVR and 11 days for patients in the SAVR group.
The results are somewhat surprising because the implantation of TAVRs using a delivery catheter is less invasive than open heart surgery.
TAVRs have achieved wide adoption among patients who are too old or frail for open heart surgery, but their use in intermediate risk patients is subject to a great deal of debate within the cardiology community, which is still trying to optimize use of the relatively new treatment paradigm.
Use in intermediate risk patients is expected to increase over time. But in a previous interview, the Sorin Group's U.S. medical director, Dr. Brian Duncan, touted multiple studies that were presented at a recent cardiology conference, which he said found that the company's sutureless surgical aortic valve replacement (SAVR) is superior to transcatheter aortic valve replacements (TAVR). Patients receiving Sorin's valve had a lower 30-day mortality rate than those who received TAVR, but were at higher risk of permanent pacemaker implantation, according to the study data.
|Edwards Lifesciences' Sapien XT--Courtesy of Edwards|
One caveat of the study is its use of fairly old data. Edwards' ($EW) first-generation Sapien valve was the only FDA-approved TAVR on the market at that time. It's now in its third generation. Improvements include a new skirt at the base of the device--described by the company as a cuff of fabric surrounding the valve frame--to minimize paravalvular leakage, or the leakage of blood around the valve.
Medtronic's ($MDT) CoreValve franchise has entered the market since the study's patients were treated. The latest generation CoreValve Evolut R is a repositionable device, meaning it can be retrieved and moved in reverse via its delivery catheter once the valve is initially positioned, allowing cardiologists to make minor adjustments, resulting in fewer complications like paravalvular leak.
TCTMD reports that another recent study of TAVRs in the American Journal of Cardiology concluded that open surgical access of TAVRs implanted using the transfemoral approach can be used regularly in intermediate risk patients because it does not lead to high rates of bleeding or other vascular complications.