Minimalist Transfemoral TAVR Reduces Costs Without Adversely Affecting Clinical Outcomes

CHICAGO, IL—A simplified, “minimalist” approach to transcatheter aortic valve replacement, performed without general anesthesia and developed to get patients mobile early and discharged quickly, results in significant cost savings without posing an increased risk to patients, according to new data from a US hospital that set out to study the strategy.

In patients with significant comorbidities, such as those with chronic obstructive pulmonary disease (COPD), minimalist TAVR might also be associated with be a reduction in mortality, say investigators.

“I really feel that the evolution of minimalist TAVR is very similar to what we saw with coronary stenting in that initially there was a steep learning curve with us trying to understand what the procedure would do to the patient,” Vasilis Babaliaros, MD (Emory University School of Medicine, Atlanta, GA), told TCTMD. “Coronary stenting began with a surgeon on standby in the surgical block downstairs and now has evolved into something much different. I think minimalist TAVR is moving in that direction because the results are so consistent.”

Presenting data at TVT 2016 in Chicago, IL, Babaliaros said the desire to simplify the procedure emerged out of necessity—their clinical program at Emory University was growing so fast and the procedure was too expensive in its current form. With hospitals in Europe already performing simplified TAVR, including those performed by Alain Cribier, MD (Université de Rouen, France) and colleagues, the Emory program was designed to adopt a similar approach.

“We really wanted to change how we were doing things,” Babaliaros said. “We wanted to simplify the procedure [and] we were running out of resources, so we had this idea to follow what some of the Europeans were doing, which was to have a simplified procedure but also to maintain the superior outcomes we talk about, such as good short- and long-term results, while decreasing resource utilization and cost. Part of that idea involves the transition from general anesthesia to conscious sedation, avoiding lines, avoiding Foley catheters, and avoiding transesophageal echocardiography [TEE].”

The minimalist transfemoral TAVR procedure used local anesthesia, minimal conscious sedation, and transthoracic echocardiography (TTE). To facilitate early discharge with the minimalist approach, Babaliaros said they worked with nurses and other hospital staff to identify patients who could move directly from the catheterization laboratory to the telemetry unit rather than to the intensive care unit (ICU). Patients treated with a standard TAVR in the hybrid operating room under general anesthesia are transferred from the operating room to the ICU for extubation and recovery, but patients treated via the minimalist approach were allowed directly to the hospital floor if they didn’t have neurologic events, vascular complications, or heart block (new left bundle branch block was allowed).

Expanding on Their Previous Report

In 2014, Babaliaros and colleagues published data comparing transfemoral TAVR with the original Sapien device (Edwards Lifesciences) using the minimalist approach in the catheterization laboratory versus the standard approach in a hybrid operating room. In that analysis, the researchers reported equivalent midterm mortality rates between the minimalist and standard approaches, but the minimalist approach cost $9,982 less than TAVR performed in the hybrid operating room. 

Speaking in a session on TAVR “Highlights and Controversies,” Babaliaros said their approach is to identify candidates for the minimalist transfemoral TAVR procedure based on anatomical rather than clinical risk. Such patients must have straightforward vascular access, weigh less than 100 kg, have no barriers to emergent intubation, be in good mental health, and be without chronic pain. The existence of chronic kidney disease or diabetes, for example, does not impact candidacy for the minimalist approach, he explained. After the procedure, patients are walking in 4 to 6 hours and attempt to eat immediately.

Among 411 patients treated with the minimalist approach at their center, the rates of major stroke, rehospitalization, and death at 30 days were not statistically different among those discharged the next day compared with standard discharge. There were trends toward less major and minor vascular complications, and significantly less need for a permanent pacemaker among those discharged the next day. More than 70% of patients discharged the next day had no paravalvular leak, which was significantly greater than those discharged later. Overall, minimalist TAVR with next-day discharge saved approximately $10,000 compared with standard discharge.

“We’re doing same-day admission and next-day discharge,” Babaliaros told TCTMD. “This means we have talked to the family and we know what type of social support they have, and where they’re going to go after the procedure. We’re moving into early mobilization and getting them home quickly. And we can reproduce that with pretty good consistency. It comes with a massive cost savings, and we think it’s better for the patient. We show it’s not only equivalent, but probably in very high-risk clinical patients—those who can’t tolerate general anesthesia, an endotracheal tube, something down their esophagus, or anything in the bladder—we have shaved all that extra risk while maintaining a good outcome.”

Babaliaros also presented data from the Society of Thoracic Surgeons/American College of Cardiology TVT Registry, which even suggested reduced 30-day mortality and mortality/stroke rates with moderate sedation compared with general anesthesia. In the registry, approximately 25% of patients were treated with moderate sedation. 

Not Completely Without Risks

Howard Herrmann, MD (Perelman School of Medicine at the University of Pennsylvania, Philadelphia), who was not involved in the study, said they have adopted a “fast-track” protocol for TAVR procedures at their hospital, which is also designed to skip the ICU and get patients out of the hospital quickly. The majority of their TAVR procedures are performed under non-intubation anesthesia with the transfemoral approach, with patients undergoing modified anesthesia care (MAC) administered by an anesthesiologist. This is a higher level of sedation compared with conscious sedation (but less than general anesthesia), said Herrmann.

“We’re 90% MAC and about 50% of our patients go on the fast track and don’t go to the ICU,” he told TCTMD. “Our average length of stay is just over 2 days. We usually monitor for an extra day and don’t have patients ambulate until the following day. A morning case, maybe they can ambulate in the evening, but if it’s an afternoon case, we usually keep them in bed rest overnight so their first ambulation isn’t at midnight when they could develop a groin complication. It also allows us to do a little extra monitoring for arrhythmias and the need for pacemaker, which might not creep up until day two or three”—something that might explain the lower rate of pacemaker implantation in the Emory series.

Likewise, the lack of TEE use might also explain why the risk of paravalvular leak was not increased among patients treated via the simplified approach and discharged the next day. TEE can be used to carefully screen for complications and paravalvular leak, including trace leaks that might not show up on TTE. However, Hermann noted that as the valves improve with newer generations, paravalvular leak might be less of issue. At their center, they also have eliminated TEE in the majority of patients, he added.

“Sometimes it’s just about medication,” said Herrmann. “These are elderly patients. Sometimes they’re not ready to go right home. It’s hard to discharge a patient on day one if they don’t have family in the area. Also, you’ve fixed their aortic valve, so maybe they don’t need all the same medications they needed before you fixed their aortic valve. Maybe their diuretics can be reduced? Sometimes it’s hard to tell on day one or even day two what that requirement is going to be.”

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