News Features

Same-Day TAVR: Anomaly or Wave of the Future?

By L.A. McKeown


Recent improvements in TAVR devices and techniques have led to declines in the average length of hospital stay. But while 2 to 3 days is rapidly becoming the norm for some patients at more experienced US centers, a surprising case report—published online July 21, 2015, ahead of print in Catheterization and Cardiovascular Interventions—raises the question of whether an overnight stay is even necessary for some patients. 

Multiple sources told TCTMD that, although the situation is unique, it may signal a change in attitudes toward TAVR.

Investigators led by Philippe Généreux, MD, of Hôpital du Sacré-Coeur de Montréal (Montréal, Canada), successfully performed transfemoral TAVR with the Sapien XT (Edwards Lifesciences) in a 65-year-old man. There were no complications, and the patient was discharged home a mere 10 hours after the procedure.

At baseline, he had severe aortic stenosis (NYHA class III) with a mean gradient of 46 mm Hg, an aortic valve area of 0.8 cm2, and an LVEF of 40%. The patient was not a candidate for surgery due to hostile chest stemming from thoracic radiation-induced CAD that had been treated with prior CABG and PCI. His baseline renal function was normal, and his STS score predicted a 6% chance of 30-day mortality.

TAVR was performed with no intubation and under conscious sedation with minimal instrumentation. Six hours after the procedure the patient was allowed to ambulate, which was well tolerated, and 4 hours after that he was discharged home. He was followed daily by phone, and reported resuming normal daily activity on day 2. TTE, ECG, and laboratory tests revealed no adverse events at days 5 or 30, and the patient was classified NYHA class I by 6 months.

Taking Up the Challenge

In a telephone interview with TCTMD, Howard C. Herrmann, MD, of the Hospital of the University of Pennsylvania (Philadelphia, PA), commented that the case is “a nice demonstration of how far we have come with TAVR, but it’s more of an extreme example of what can be done rather than what should be done in a general sense. Still, 10 years ago no one would have anticipated this occurring.”

Ted Feldman, MD, of Evanston Hospital (Evanston, IL), agreed, telling TCTMD in a telephone interview that the case is emblematic of the rapid streamlining of TAVR, comparing it to the “leaps and bounds” that have been seen over the years with PCI. “A generation ago if you had told family members of someone who had just had a STEMI that everything looks good after the PCI and the patient will likely go home tomorrow, they would be in disbelief,” he said. “We are at the beginning of that same sea change with TAVR.”

Dr. Feldman noted that the recent FDA approvals of both the balloon-expandable Sapien 3 valve (Edwards Lifesciences) and repositionable self-expanding Evolut R device (Medtronic) are likely to make earlier discharge even more feasible as more patients have “perfect femoral access outcomes.” Still, he cautioned, the case is “on the front end of the trend” and not something that most clinicians would consider for their TAVR patients.

Line Dancing on Day 5

Dr. Généreux and colleagues acknowledge that same-day discharge is challenging, but they say strict principles may help identify those patients in whom it may be possible. These include procedural factors such as absence of major complications, patient-specific factors including cognitive and behavioral abilities, and environmental factors such as adequate support at home, proximity to the center, and capacity for next-day phone follow-up.

Sending the patient home that day “was not something I thought about prior to the procedure,” Dr. Généreux said in a telephone interview with TCTMD, adding that about one-third of TAVR patients at his center are discharged home the following day as long as there are no complications during the overnight observation, with the remainder typically discharged within 48 hours.

“This patient was definitely unusual in that he was young and also very active,” Dr. Généreux observed, explaining that the patient was his first case for the day. “When I went to check on him at noon, he was sitting up in bed eating lunch and asked me if he could go home that night.”

Dr. Généreux said he weighed the fact that “there were absolutely no complications and he was motivated to go home” against the possible risks. “By late afternoon he was walking the hallway and joking with me, and he promised to follow all instructions so I agreed to the discharge.”

Dr. Généreux admitted to having a bit of unease after the patient went home and checking in on him first thing the next morning. “There were absolutely no bleeding issues, nothing,” he said. “He later told me that he went line dancing on day 5.”

The Reimbursement Conundrum

According to Dr. Herrmann, average length of stay in the United States has dropped from 7-10 days in the early years of TAVR to 5-7 days in recent years, with intermediate-risk patients treated at the most experienced centers often going home on day 2 or 3.

But unlike in Canada where the same-day TAVR case was performed, the United States has stricter rules tied into Medicare reimbursement that inflict financial penalties for sending patients home early. Dr. Herrmann referred to the “perverse transfer penalty,” whereby Medicare will withhold payment for home healthcare needs related to the procedure.

“So while it may make sense to send a patient home on day 1 with a visiting nurse on days 2 and 3, you actually lose money compared with keeping them until day 3,” he said. “Not that that should be the criterion by which we make these decisions, but it is certainly one that hospitals look at.” However, Dr. Herrmann said these calculations may begin to change soon, because geometric mean length of stay is expected to be lowered and therefore penalties should be fewer.

On the whole, shortening length of stay and predicting who can safely go home earlier is a goal to work toward in TAVR, he added. In a recent paper, Dr. Herrmann and colleagues describe how utilization of a fast-track protocol at 2 institutions identified a subgroup of transfemoral TAVR patients—with a mean age of about 85 years—in whom ICU and post-operative length of stay were substantially reduced and direct costs were lowered by approximately $10,000 with no compromise of care.

While navigating Medicare rules and penalties clearly can be tricky, a free app developed by Christopher U. Meduri, MD, MPH, of Piedmont Heart Institute (Atlanta, GA), and Brian J. Potter, MD, MSc, of Centre Hospitalier de l’Université de Montréal (Montreal, Canada), aims to make the process easier. Known as Post-TAVR, it helps clinicians calculate the optimum number of days of hospital stays for US patients based on Medicare reimbursement rules.

Several Unknowns

Reimbursement aside, same-day discharge in TAVR patients is “a complicated issue that isn’t purely medical,” Dr. Herrmann added.

“We all recognize that bad things can happen when you are hospitalized more than necessary and it makes sense to send patients home as soon as they are ready to go home, but we need to be certain that doing so the same day doesn’t have more risks than benefits,” he said. For example, no data exist on the risk of bleeding in TAVR patients sent home the same day.

“If the risk of bleeding is 1 in 10, which it certainly may be, I don’t think we are going to be sending too many patients home,” he said. “Similarly, are we going to be comfortable that AV block is so rare that it can’t occur in the first 24 to 48 hours? What about readmission rates?”

Dr. Hermann added that medication titrations are common in the days after TAVR, asking, “Are we going to send patients home on the medication they came in on, or what we think they are going to need? What will the readmission rates be for those in whom we guess wrong?”

Moreover, sending a TAVR patient home the same day is only practical for an operators’ first case, as it was here, Dr. Hermann observed. Otherwise there would not be enough time during the course of the day for observation.

Why the Rush?

David J. Cohen, MD, MSc, of Saint Luke’s Mid America Heart Institute (Kansas City, MO), added that while allowing patients to spend the night in their own bed instead of the hospital is nice, “most patients who undergo TAVR in my experience don’t view staying in the hospital 1 or 2 nights as a big inconvenience, and they are not of the age where they need to rush home to take care of their kids or something.”

Dr. Cohen acknowledged that greater operator experience, improved techniques, and lower risk patients are driving the move toward earlier discharge, and he noted that several patients at his institution have gone home the next day, including one implanted with a CoreValve. While he is unaware of any same-day cases that have been done with CoreValve, it would be theoretically possible if the patient already had a pacemaker, he said.

But Dr. Herrmann questioned the impetus for same-day discharge, concluding that with so many things to try to improve upon in the TAVR world, “it doesn’t strike me as necessary to strive toward [this].”

Dr. Généreux said he understands the criticism and believes that same-day discharge should be done sparingly.

“I felt it was appropriate for this 1 patient, and it’s not something I have replicated since then. It was the perfect combination of a patient willing to go home, a perfect outcome with no complications, and perfect timing because he was the first case and had 10 hours of observation.

“That being said, this isn’t something I would anticipate doing in more than 1% of my patients,” he concluded. “And I most certainly would never compromise the safety of a patient to prove a concept.”

 

Source: 
Genereux P, Demers P, Poulin F. Same day discharge after transcatheter aortic valve replacement: are we there yet? Cath Cardiovasc Interv. 2015;Epub ahead of print. 

Disclosures:

  • Dr. Genereux reports receiving speaker honoraria from Edwards Lifesciences. 
  • Dr. Feldman reports receiving consulting fees and grants from Abbott Vascular, Boston Scientific, and Edwards Lifesciences.
  • Dr. Hermann reports receiving research funding to his institution from multiple TAVR device manufacturers and serving as a consultant to Edwards Lifesciences. 
  • Dr. Cohen reports receiving research support and consulting income from multiple device and pharmaceutical companies and speaking honoraria from AstraZeneca. 

Related Stories:

 

 

Comments

Aortic Valve