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A groundbreaking study has determined that Transcatheter Aortic-Valve implantation (TAVI) treatment is non-inferior to Surgical Aortic-Valve Replacement (SAVR) for low and intermediate surgical risk patients suffering from severe aortic stenosis.
The study, led by Dr. Stefan Blankenberg and conducted across 38 sites in Germany, aimed to fill the knowledge gap concerning optimal treatment strategies for low-risk patients eligible for both TAVI and SAVR procedures. The patients were followed-up to track the number of fatal and nonfatal strokes or deaths from any cause within one year following treatment.
Out of 1414 patients, 701 received TAVI and 713 underwent SAVR, with the mean age of the patients being 74 years old. After one year, the Kaplan-Meier estimate of the primary outcome was significantly lower in the TAVI group when compared to the SAVR group, demonstrating TAVI’s non-inferiority. Death rates were almost halved, and stroke incidences also decreased in the TAVI group compared to those in the SAVR group.
This new research follows up on a similar study conducted in 2017, which compared TAVR and SAVR for intermediate-risk patients. That study likewise found TAVR to be a non-inferior alternative to surgery at the 24-month mark.
Both studies reveal varied and different potential complications associated with each procedure. Patients undergoing surgery reported higher rates of acute kidney injury, atrial fibrillation, and blood transfusions. On the other hand, patients receiving TAVR experienced higher rates of residual aortic regurgitation and need for pacemaker implantation.
The findings from these two complementary studies show that TAVI can indeed be a non-inferior treatment strategy to SAVR for low to intermediate-risk patients. However, each approach may come with its unique set of complications, and thus, the optimal treatment should be selected based on a thorough consideration of the patient’s condition and other relevant factors.
INFORMATION BOX:
– Aortic stenosis is a condition where the aortic valve narrows, hindering blood flow from your heart into your aorta and onward to the rest of your body.
– TAVI is a less invasive procedure than SAVR, and is often used for patients who may not be able to withstand the strain of an open-heart surgery.
– Despite the promising results, it’s essential that healthcare providers consider the patient’s overall health and specific heart condition before deciding on the appropriate treatment strategy.
Reference 1: Blankenberg, Stefan, et al. “Transcatheter or Surgical Treatment of Aortic-Valve Stenosis.” New England Journal of Medicine, 8 April 2024.
Reference 2: Reardon, Michael J., et al. “Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients.” New England Journal of Medicine, 6 April 2017.
Reference 3: NCT03112980, ClinicalTrials.gov