The late-breaking WATCH-TAVR trial demonstrated that performing a Watchman left atrial appendage occlusion (LAAO) simultaneously with transcatheter aortic valve replacement (TAVR) is a safe and cost-effective approach for patients with severe aortic stenosis and atrial fibrillation (AFib).[1] This type of combined structural heart interventional procedures has peaked the interest of Medicare and may become more common in the years to come.
The trial's findings were presented at TCT 2023 in San Francisco by Samir Kapadia, MD, chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine at the Sydell and Arnold Miller Family Heart, Vascular and Thoracic Institute at Cleveland Clinic. Kapadia said in an interview with Cardiovascular Business that this combined approach not only simplifies patient care, but also reduces the economic burden on healthcare systems. It saves the patient from an extra procedure, for example, and offers reductions in anesthesia and procedure time. It also eliminates the need for an extra CT scan for preplanning and reduces the number of required catheters.
Kapadia added that the same venous guide catheter for the temporary TAVR pacing lead can be used to guide the LAA device, and the Watchman portion of the procedure uses the same vascular access point.
"Forty percent of TAVR patients have AFib in the high-risk group and there are about 20% in the low-risk group. So it's a very large population of TAVR patients," Kapadia explained. "The study was designed for non-inferiority to say that if you're doing two procedures, we are not hurting anybody's safety. It turns out that the non-inferiority was met. The overall risks of dying, staying in the hospital, having contrast nephropathy, none of them were higher in the combined procedure compared to single procedure."
Details of the WATCH-TAVR trial
The WATCH-TAVR trial's primary endpoint was a composite of all-cause mortality, stroke, and major/life-threatening bleeding over a two-year period.
Results of the trial revealed that the combined procedure was noninferior to TAVR alone. The rates of adverse events, including mortality, hospital stays, and contrast nephropathy, were not higher in patients who underwent the simultaneous procedures.
Through two years, the primary endpoint of all-cause mortality, stroke or major/life-threatening bleeding was 33.9% in patients treated with the combined procedure and 37.2% in those treated with TAVR alone, a difference that met criteria for noninferiority with a P < 0.001. The trial did not show superiority.
Reducing healthcare costs with combined procedures
As we move toward a more patient-centric and cost-effective healthcare system, the results of this trial could become a crucial building block for future advancements in cardiovascular procedures.
Combining LAAO with TAVR offers several advantages, including potential cost savings. By performing both procedures in a single session, the need for additional resources, such as catheters and access points, is minimized, leading to reduced costs. Furthermore, patients avoid the expenses associated with a second hospital admission.
The WATCH-TAVR trial's success has the potential to reshape the landscape of cardiac procedures, emphasizing the advantages of combining different interventions in a single session. Kapadia and his team are actively discussing with Centers for Medicare and Medicaid Services (CMS) the possibility of creating a combined reimbursement code that reflects the value of this approach. They have been receptive to the idea, he said.
Even if it results in slightly reduced payments for the procedures, this strategic shift in patient care may pave the way for future trials. It opens up new possibilities for combining other complementary procedures.
Kapadia believes there will be a big push in the next few years to combine more procedures into one-stop-shops for patients to boost cardiology department efficiency, patient satisfaction and even outcomes.
"AFib ablation and Watchmen are happening together, and Watchman may happen together with CardioMEMS. So there are so many things that are complimentary in the same patients and this trial shows that we can do it relatively safely together. I think there is a good chance that we can potentially make this a reality," Kapadia explained.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com