A new international study has found that heart patients experience better outcomes when cardiologists follow a standardized approach during transcatheter aortic valve replacement (TAVR), a minimally invasive procedure for treating severe aortic stenosis.
Published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI), the study highlights the benefits of using a specific technique—known as the cusp overlap technique (COT)—when implanting self-expanding TAVR valves. Researchers found that this method leads to consistent, positive results and significantly lowers the risk of complications, including the need for a permanent pacemaker.
The findings come from the Optimize PRO study, which followed more than 600 patients treated with transfemoral TAVR between 2019 and 2023. All patients received the Evolut PRO or Evolut PRO+ valve from medical device maker Medtronic. The procedures were conducted across 50 healthcare centers worldwide.
Each patient underwent clinical and echocardiographic evaluations at the time of the procedure and again at discharge. Follow-up exams were conducted after 30 days, and a one-year follow-up is planned.
Based on years of clinical experience, the study authors developed a set of best practices, which included the use of the Lunderquist Double-Curve Extra-Stiff guidewire by Cook Medical. They also created a four-part checklist for applying the cusp overlap technique.
Four Steps in the COT Checklist:
Use of a reconstructed CT angiography overlay showing the cusp overlap view.
A fluoroscopic image confirming the guidewire’s correct placement in the left ventricle.
A fluoroscopic image showing 3 mm depth in the cusp overlap view after full contact below the noncoronary cusp.
Final aortography performed using the cusp overlap view.
Key Findings
The average patient age was 79, and 47% were women. Most had hypertension, and many also had diabetes or a history of heart rhythm disorders.
Patients treated using the standardized protocol had a 30-day combined rate of death or stroke of just 5.1%. Mortality alone was 0.8%, while disabling stroke was 1.7%. The rate of permanent pacemaker implantation (PPMI)—a common complication—was 11.1%.
Importantly, no patients were found to have moderate or severe aortic regurgitation at discharge. Minimal or no regurgitation was observed in over 76% of patients. Similarly, 76.4% had no or trace paravalvular regurgitation (PVR), while 23.6% had mild PVR.
The median hospital stay was just two days, and many patients were able to go home the next day.
Following the full four-step checklist made a clear difference. In cases where the checklist was followed, the 30-day PPMI rate was 6.4%. In cases where it was not followed, the rate rose to 18.5%.
Use of the recommended Lunderquist guidewire was also linked to better outcomes. It was used in 80.7% of procedures. In those cases, the PPMI rate was 9%, compared to 19% when it wasn’t used.
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