Heart patients benefit when cardiologists follow a standardized TAVR protocol
As transcatheter aortic valve replacement (TAVR) continues to gain momentum as a go-to treatment option for patients with severe aortic stenosis, cardiologists and device manufacturers alike are working to identify new ways to make the procedure as safe and effective as possible.
According to a new global study published in JSCAI, for example, following a standardized protocol and using the cusp overlap technique (COT) when implanting a self-expanding TAVR valve is associated with consistently positive outcomes and a minimized risk of complications. The COT is especially important, researchers explained, because it dramatically reduces the odds of permanent pacemaker implantation (PPMI).
A closer look at Optimize PRO
The Optimize PRO study included data from more than 600 patients who underwent transfemoral TAVR at one of 50 facilities around the world from 2019 to 2023. All patients received an Evolut PRO or Evolut PRO+ TAVR valve from Medtronic.
Clinical and echocardiographic evaluations were performed on each patient at the time of treatment and at discharge. Follow-up assessments took place after 30 days, and a one-year follow-up was also scheduled. Best practices were determined by the study’s authors based on years of TAVR experience. Using the Lunderquist Double-Curve Extra-Stiff guidewire from Cook Medical, for example, was specifically recommended.
In addition, the group established a COT compliance checklist that included four steps:
- A reconstructed computed tomography angiography overlay of the cusp overlap view;
- A fluoroscopic image of the wire appropriately positioned in the left ventricle;
- A fluoroscopic image demonstrating 3 mm depth in the cusp overlap view after full annular contact below the noncoronary cusp (NCC); and
- A final aortography performed in the cusp overlap view.
Exploring the data
The mean age for these patients was 79.1 years old, 47% of patients were women and the mean Society of Thoracic Surgeons score was 3.2%. Hypertension was the most common comorbidity, followed by diabetes, a history of arrhythmia, prior percutaneous coronary intervention and a history of atrial fibrillation or atrial flutter.
Following the TAVR recommendations included in the study’s standardized protocol was associated with a 30-day rate of all-cause mortality or stroke of 5.1%. The all-cause mortality and disabling stroke rates after 30 days were 0.8% and 1.7%, respectively. The PPMI rate was 11.1%. No patients showed signs of moderate or severe aortic regurgitation at discharge, and no/trace aortic regurgitation was present in 76.2% of patients. No/trace paravalvular regurgitation (PVR), meanwhile, was present in 76.4% of patients, and mild PVR was seen the other 23.6%. The median length of stay was two days, and many patients were eligible for next-day discharge.
The four-part COT checklist was followed for 50.3% of TAVR cases and not followed in 39.7%. It was unclear if the checklist was followed or not in the other 10% of cases. PPMI after 30 days was seen in 6.4% of cases where the checklist was followed and 18.5% of cases where it was not followed.
The Lunderquist guide wire, meanwhile, was used for 80.7% of cases; not using it was linked to a significantly higher PPMI rate (19%) than using it (9%).
Another key takeaway was the fact that implementing a specific TAVR protocol may be associated with a learning curve as cardiologist adjust. While more than one-third of participating sites had no cases of PPMI after 30 days, just 12 sites accounted for 43.1% of PPMI cases.
“The Optimize PRO study was conducted to evaluate the standardization of procedures in a diverse group of aortic stenosis patients worldwide,” wrote first author Kendra J. Grubb, MD, MHA, MSc, a veteran cardiothoracic surgery specialist with Emory University who now serves as Medtronic’s chief medical officer, and colleagues. “The study aimed to determine whether implementing best practices for Evolut PRO/PRO+ implants improved 30-day outcomes across international structural heart centers with varying practice techniques. The study found outcomes are reproducible when the essential steps of the protocols are followed. These findings further support the standardization of best practices for TAVR with Evolut.”
Co-author Hemal Gada shares his perspective
Interventional cardiologist Hemal Gada, MD, medical director of the structural heart program at UPMC Pinnacle in Harrisburg, Pennsylvania, and president of its Heart and Vascular Institute, was a co-author of Optimize PRO. He spoke to Cardiovascular Business about his team’s efforts to help educate cardiologists about the best techniques to consider when deploying these self-expanding TAVR valves.
“What we were targeting was something that would be able to be embraced not just in the United States, and not just in the United States and Canada, but something that would have international appeal,” he said. “Having a homogeneous, simple procedure with just a few steps that you need to follow improves patient outcomes.”
Gada emphasized the importance of these initial findings from Optimize PRO, especially the reduced pacemaker rate and minimal PVR.
“We know the clinical performance of this transcatheter heart valve platform is excellent,” he said. “Getting these types of acute outcomes, I think, puts it head and shoulders above the others in its class.”
Medtronic, the company behind the self-expanding Evolut platform, did fund this analysis.
Click here to read the full study in JSCAI, a Society for Cardiovascular Angiography & Interventions journal.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.