Pandemic Prompts Closer Look at Same-Day Discharge After TAVI

Concerns over reimbursement need to be solved before this protocol can be used going forward, study author says.

Pandemic Prompts Closer Look at Same-Day Discharge After TAVI

Sending home select patients who have had elective, minimalist TAVI with no complications the same day as their procedure is safe and feasible, according to an analysis of one high-volume center’s protocol, which was put in place when COVID-19 was taking hold.

“When the pandemic hit, amidst the concern and planning of what to do, our heart team started a conversation almost immediately about how can we brainstorm ways to move forward through the pandemic and not restrict access to care for our patients specifically with aortic stenosis,” senior author Chandan M. Devireddy MD, MBA (Emory University Hospital Midtown, Atlanta, GA), told TCTMD.

They had previously discussed the possibility of same-day discharge (SDD) at their institution, but it had never been done. The desire to minimize potential patient exposure to the virus and also free up hospital beds tipped the scales. “Things have changed quite a bit, but at that time many patients were hesitant to come anywhere near a hospital even if they were suffering from NYHA class III/IV symptoms from aortic stenosis,” Devireddy said. Once they finalized their protocol, “there were several patients that said okay, we'll consider coming in but only if we're part of this pathway. They just would not even consider coming into the hospital for a night.”

Commenting on the study for TCTMD, Philippe Généreux, MD (Morristown Medical Center, NJ), who has been a long-time proponent of early discharge after TAVI, said the findings illustrate a growing need for efficiency in medicine beyond COVID-19’s challenges. “[The pandemic] really put pressure on us to be more efficient but at the same time, to be safe,” he said. “We did same-day discharge before, but now really the pandemic accelerated or triggered the need for more same-day discharge.

“This is something that we're going to see more and more commonly,” he continued. “As TAVR advances, I think we're going to be less and less complacent and we probably are going to keep this pandemic-triggered efficiency as a collateral.”

Safe and Feasible

In their paper, published online December 31, 2020, ahead of print in Catheterization and Cardiovascular Interventions, Devireddy along with Emily Perdoncin, MD (Emory University Hospital Midtown, Atlanta, GA), and colleagues outline their same-day discharge TAVI pathway, which was in place between March and July 2020. Patients received imaging-guided femoral access and nurse-led conscious sedation, although a final determination of eligibility for same-day discharge was made following the procedure based on patient history, outcome, and postprocedure clinical status.

Among the 122 patients who underwent TAVI over the study period, 29 patients (23.7%) were discharged via the SDD protocol. Patients were most commonly ineligible to go home the same day because of new conduction abnormalities (21.5%) and general anesthesia (10.7%).

Compared with the 128 patients treated between July 2018 and July 2020 who were discharged the day after TAVI at their institution but would have qualified for the SDD pathway, there were no differences in the primary endpoints of mortality, delayed pacemaker placement, stroke, and cardiovascular readmission at 30 days. Additionally, neither group had any in-hospital complications.

30-Day Outcomes

 

SDD

(n = 29)

NDD

(n = 128)

P Value

Mortality

0

0

-

Delayed Pacemaker Placement

0

0.8%

> 0.99

Stroke

0

0.8%

> 0.99

Cardiovascular Readmission

0

5.5%

0.35


Stenosis severity was similar between the study and control arms. Additionally, procedural characteristics were comparable between the groups, with trends toward greater use of embolic protection among the next-day discharge patients (28.9% vs 17.2%; P = 0.20) and higher use of self-expanding valves in the SDD group (17.2% vs 7.0%; P = 0.14).

At 30 days, aortic valve mean gradient trended higher for those discharged home the next day (12.5 vs 10.6 mm Hg; P = 0.05) and the average peak velocity was similar between the two groups (2.5 vs 2.2 m/s; P = 0.06). Lastly, the percentage of patients with NYHA class III or greater symptoms at 30-day follow-up was similar between the two groups (3.2% vs 3.6%; P > 0.99).

Reimbursement Questions

Généreux said that regardless of whether a patient is discharged home the same day or the next day, early discharge should be the goal for appropriate patients. “Obviously when you finish at 4 PM or 5 PM, the patient kind of missed the window to be discharged safely home because you still want to observe him for 6-8 hours and you don't want to discharge the guy at midnight,” he said. “But when you have a length of stay less than 24 hours after a valve replacement, I think this is pretty good and this is what we should aim for.”

From the patient quality of life and quality of care standpoint, that's a big deal. Chandan M. Devireddy

The protocol at his institution is similar to that used in the study. However, Généreux said his team performs remote monitoring on every patient discharged the same day as their TAVI with a Zio Patch (iRhythm) and that they also use the Early Bird system (Saranas) to detect any in-hospital bleeds.

Devireddy explained that his institution stopped their SDD protocol as of early August 2020 due to potential concerns over reimbursement and readily available hospital beds. “In the initial phases, we were told from the regulators that there was a willingness to be flexible with payment definitions and the overall regulatory picture around an inpatient procedure,” he said. “But after our initial experience and as we moved further along in the pandemic, there was just more uncertainty.”

While he has yet to hear of any cases where patients were completely denied coverage, “there was definitely enough smoke of that as a possibility and folks didn't want to take the chance of having to deal with fire,” Devireddy added. “So, I think a lot of centers have been hesitant to go in full-scale unless they've got an absolute blessing from the healthcare administration that the procedures will be reimbursed. We're in an active process of discussion with our administrative team to see if there's a way that we can move forward that makes everybody happy, especially given the recent surge” in COVID-19 cases.

What ultimately needs to be resolved is the definition of an inpatient procedure, which relevant to Centers for Medicare & Medicaid Services (CMS) reimbursement, he said. “If you do a TAVR and they go home the same day, are you somehow violating the principle and the idea of how TAVR was approved by CMS in the first place?”

Outside of the pandemic, Devireddy noted that there are several tangible benefits to discharging TAVI patients early. “Patients with aortic stenosis typically are higher risk in general than I think your standard PCI patient, so if a patient like this can recover at home, it's one less day in the hospital, one less day of nosocomial infection, less chance of things like hospital-related falls or potential errors, and the benefit of just being able to recover in a place that's familiar to them and around friends and family,” he said. “Just from the patient quality-of-life and quality-of-care standpoint, that's a big deal.”

Sources
Disclosures
  • Perdoncin reports no relevant conflicts of interest.
  • Devireddy reports serving as a consultant for Medtronic, Edwards Lifesciences, Shockwave Medical, and ReCor Medical. His employer has research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific.
  • Généreux reports serving as a consultant for Edwards Lifesciences, Medtronic, Saranas, Shockwave, and Teleflex.

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