Merits of Minimalist TAVR: Patient Satisfaction and a Better Bottom Line

CHICAGO, IL—A “minimalist” approach to transcatheter aortic valve replacement can be safely done without an increased risk of patient morbidity or mortality at experienced hospitals, according to several presentations at TVT 2017.

In a session devoted to simplified TAVR pathways, including some single-center results, researchers outlined the many reasons for adopting protocols that see patients treated without general anesthesia and moved from the catheterization laboratory directly to the telemetry floor and discharged the next day.

“What do patients want?” asked Vinod Thourani, MD (Emory University, Atlanta, GA), one of the pioneers of the minimalist TAVR critical-care pathway. “They all want excellent outcomes. They want the least invasive option possible, a quick return to normal activity, the least amount of morbidity, and the shortest hospitalization. That’s really where minimalism comes into play.”

The biggest impact is what we do once the patient is finished with the procedure. Christopher Meduri

Christopher Meduri, MD (Piedmont Heart and Vascular Institute, Atlanta, GA), said the minimalist approach, which he instead calls an “optimized” TAVR protocol, means physicians are no longer just proceduralists, but rather are stewards of the entire process of care.

“What does minimalist mean?” Meduri asked TCTMD. “That you just keep people awake, or is it what you do after the procedure? I think ‘minimalist’ is the wrong term and ‘optimized’ is more appropriate. That could be minimizing what we do during the procedure but also optimizing what we do afterwards. The biggest impact is what we do once the patient is finished with the procedure—are we getting them up and ambulatory? Are we avoiding narcotics and sedatives? Essentially, are we getting them to as normal a state of health as quickly as possible?”

The Emory University Experience

Since 2007, the structural heart and valve center at Emory University has performed 1,900 TAVR cases, with 1,020 taking place in the cath lab. Of these, more than 700 patients have been sent directly to the telemetry floor—rather than the intensive care unit—to recover after the procedure and 298 have been discharged the next day.

In-hospital and 30-day mortality rates among high-risk patients treated via the simplified protocol were 1.2% and 1.4%, respectively. Major vascular complications occurred in 3.8% of patients and the need for a permanent pacemaker was just 6.9%. Since 2014, Thourani said ICU utilization has declined significantly as have their labor costs.

[W]e didn’t want to be trading length of stay for worse outcomes. Kendra Grubb

“As you decrease your labor costs, guess what, it doesn’t help your reimbursement but it helps your bottom line, which is obviously something for us to think about,” said Thourani.    

Kendra Grubb, MD (University of Louisville, KY), also provided a snapshot of “awake” TAVR at their smaller, lower-volume center. During the presentation, she highlighted the financial impact that competition played in their decision-making. Although Jewish Hospital/University of Louisville has the largest TAVR experience in Kentucky—they were first to offer TAVR and participated in PARTNER 2—other hospitals are now in on the action.

“Basically, we had outside pressures,” said Grubb. “There were going to be two other TAVR sites within our small pool of patients, a population of about one million.”

Given patient preferences for the simpler approach and its early success, physicians opted for minimalist TAVR as one way to stand out from the crowd. The program was started in 2014, and they have now treated 300 patients to date without general anesthesia. Their early results, which they assessed after 50 cases, revealed no in-hospital mortality and two deaths at 30 days. Major vascular complications occurred in two patients.

Overall, there was no significant difference in outcomes when compared with 50 patients treated with general anesthesia (prior to the minimalist program starting), said Grubb.

“This was very important to us because we didn’t want to be trading length of stay for worse outcomes,” she said. “We found that there was no difference whatsoever at that time period. However, we did notice our discharge-to-home rate was almost 80% [with awake TAVR] versus less than 60% with general anesthesia.”

Making Money, Losing Money

Axel Linke, MD (University of Leipzig, Germany), who moderated the session and has established a dedicated TAVR recovery ward at his hospital, said the minimalist approach is almost nonexistent in his country.

“In Germany, you have to keep them in the hospital for at least 5 days to be fully reimbursed,” said Linke. “So, financially, it doesn’t make sense to discharge them on day 2 or day 3 because you’re going to lose thousands of dollars per day. The economic situation is a different one. [US hospitals are] making money by sending patients home early. We lose money when we send them home early.”

Linke cautioned physicians about being overzealous in stripping TAVR down to the bare minimum, likening the procedure to flying a plane. While the pilot may be well prepared, turbulence can result in unexpected trouble in the cockpit, as well as in the cath lab. Like Meduri, he said there isn’t a clear consensus on what constitutes minimalist TAVR, and while as simple as possible might be the goal, this is not the same thing as doing the procedure as well as possible.

Didier Tchétché, MD (Clinique Pasteur, Toulouse, France), said his institution currently performs 600 TAVRs per year with the minimalist approach. As a result, procedure times are shorter and patient recovery is better (early ambulation is stressed). “So far, we’ve had almost no waiting list,” he said. “If we want to be a big center, we have to be able to treat all these patients. We now treat patients every day, [doing] two, five, or seven procedures every day.”  

To TCTMD, Meduri said he doesn’t believe there is a universal minimalist protocol that will work at every hospital, but there is no debate on the importance of getting patients moving as soon as quickly possible after TAVR. At their center, where they have performed approximately 600 minimalist/optimized TAVR cases, the discharge-to-home rate is close to 95%, which is up from 60%. 

If a patient requires assisted medical services or cardiac rehabilitation after minimalist TAVR, “then something else happened in the context where I feel I didn’t do right,” said Meduri. “But if I’m able to get you back to the same state of health quickly, that tells me we at least did it in the right fashion.”

Randomized, Controlled Data Coming Soon

The Emory physicians had performed TAVR for 5 years before starting the minimalist program, or approximately 300 cases. In doing so, they transitioned from transesophageal echocardiography to transthoracic echocardiography, which they say is critical for minimalist’s success.

Speaking during the session, Thourani said that while their goals are to minimize the procedure and cost, “patient safety is paramount.” Not every patient is a candidate for minimalist TAVR, he noted, and all cases are reviewed in detail by the heart team. Patients eligible for minimalist TAVR have straightforward vascular access, weigh less than 100 kg, have coronary arteries of an acceptable height, no barriers to emergent intubation if needed, no chronic pain, and are of sound mental health.

David Wood, MD (Vancouver General Hospital, Canada), and John Webb, MD (St. Paul’s Hospital, Vancouver, Canada), are currently leading the Multidisciplinary, Multimodality, but Minimalist Approach to TAVR Study, a trial testing the efficacy, feasibility, and safety of the Vancouver 3M Clinical Pathway protocol in patients undergoing elective transfemoral TAVR. There were 13 North American centers participating in the now finished study comparing conventional TAVR versus a minimalist approach, and results will be presented at TCT 2017 in Denver, CO.