Next-Day Discharge Safe After Uncomplicated Transfemoral TAVR

Discharging patients within 24 hours of a transfemoral TAVR procedure performed without complications appears to be a safe approach, data from a single Italian center suggest. The findings may have implications for patient care in the COVID-19 era, experts say.

There were no differences in rates of mortality or rehospitalization for heart failure through the first year between patients discharged the next day and those who left the hospital later, according to researchers led by Giuliano Costa, MD, and Marco Barbanti, MD (both of Policlinico-Vittorio Emanuele Hospital, University of Catania, Italy).

Patients with a prior permanent pacemaker implant (PPI) and those with a preprocedural CT angiography assessment were more likely to receive next-day discharge, they report in a study published in the August issue of EuroIntervention.

“Although different studies have already demonstrated the feasibility of early or next-day discharge after transfemoral TAVR, the vast majority of them took into account highly selected patients,” mostly excluding those with comorbidities associated with longer hospitalizations, Barbanti told TCTMD in an email. “In our study, we have included all consecutive patients referring to our [center] for TAVR. We then showed that a next-day discharge strategy is feasible and safe in a notable percentage of unselected TAVR patients.”

This study, commented David Wood, MD (University of British Columbia, Vancouver, Canada), “confirms what’s already out there in two large prospective multicenter trials, the 3M TAVI study and the FAST-TAVI study, . . . that basically said in carefully selected patients, early—ie, next-day—discharge is both efficacious and safe. And so it builds on the existing evidence base.”

Facilitating next-day discharge using a minimalist treatment approach has taken on even greater importance during the COVID-19 pandemic, when healthcare resources are being strained to the limits and use of many cardiovascular procedures and tests is being restricted or stopped altogether, both Wood and Janarthanan Sathananthan, MBChB (University of British Columbia), stressed in a joint interview with TCTMD.

Use of TAVR has been expanding into lower-risk patients, which has implications for hospital resource use, and prior to the pandemic there was already movement toward more next-day or early discharge, Sathananthan noted. “In the current COVID pandemic, centers are going to be under pressure for resources, and so showing that they can still provide essential cardiovascular care by having a very short length of stay [and] minimal use of hospital resources and also mitigating the risk of patients contracting COVID while they’re in hospital is going to be key,” he said.

Barbanti said he agrees with Wood and Sathananthan, who co-authored an accompanying editorial. The COVID-19 crisis has required efforts to minimize hospitalizations and contact between cardiac patients and healthcare workers whenever possible, he noted. “In this setting, minimalist TAVR programs are totally in harmony with this necessity and helps national health services to continue offering an appropriate treatment to patients with severe aortic stenosis even during this difficult time.”

Streamlining TAVR

In recent years, indications for TAVR have expanded to encompass a broader group of patients. This has led some groups to work on simplifying pathways “to identify a more efficient system for patient assessment screening, to optimize the TAVI procedure without compromising its safety, to accelerate patient recovery and mobilization after the procedure, and to minimize unnecessary use of medical resources,” Costa, Barbanti, and colleagues write in the paper.

In the current study, the investigators set out to evaluate the safety of discharging patients within 24 hours of an uncomplicated transfemoral TAVR procedure performed with a minimalist approach (local anesthesia and only angiographic guidance with transthoracic echocardiography as backup). The analysis included 1,232 patients who were successfully treated and discharged from their center between June 2007 and August 2018. Patients had a mean age of 80.9 and, on average, had intermediate surgical risk (STS score 4.4%). Most (73.9%) were treated with a self-expanding valve.

Eligibility for discharge within 24 hours was determined using the following criteria: NYHA class II or less; no chest pain attributable to cardiac ischemia; no untreated major arrhythmias; no fever during the last 24 hours and no signs of an infectious cause; independent mobilization and able to self-care; preserved diuresis; blood creatinine increase of less than 0.3 mg/dL from baseline; stable hemoglobin in two consecutive samples; no paravalvular leak with aortic regurgitation less than moderate; no stroke/TIA; and no hemodynamic instability. Ultimately, 13.0% of patients were discharged within a day, although Barbanti said that figure was about 35% in the last 2 years of the study period.

Those in the next-day discharge group had lower rates of prior stroke, pre-existing A-fib, and NYHA class III/IV disease, higher rates of previous pacemaker implantation and preprocedural CT angiography, and a larger native aortic valve area. All of those differences were eliminated after propensity matching, which resulted in 160 matched pairs of patients.

In the matched analyses, there were no differences between the next-day and later discharge groups in all-cause mortality (1.2% vs 0; P = 0.16) or CV mortality (0.6% vs 0; P = 0.32) at 30 days, with no cases of MI, disabling stroke, or rehospitalization in either group.

Outcomes remained similar through 1 year of follow-up, with no differences in all-cause mortality (6.3% vs 8.1%; P = 0.52), stroke (0.6% vs 2.5%; P = 0.18), rehospitalization for heart failure (2.5% in each group; P = 1.00), or the composite of all-cause death or heart failure rehospitalization (P = 0.69).

In an analysis that excluded patients with a procedure-related complication, predictors of next-day discharge were a prior PPI (OR 2.06; 95% CI 1.21-3.51) and availability of preprocedural CT angiography assessment (OR 1.71; 95% CI 1.15-2.54). A pre-existing pacemaker provides “protection in case of new-onset advanced atrioventricular disease block related to TAVI, avoiding the necessity of close rhythm monitoring after the procedure as well as additional immobilization for PPI,” the authors say. And CT angiography before the procedure “facilitates selecting the most suitable device considering the anatomy of the aortic root and iliofemoral vascular axes, thus permitting in particular a decrease in vascular complication rates.”

Minimalist Approach Crucial in the COVID-19 Era

In their editorial, Wood and Sathananthan say that achieving early discharge in a high proportion of patients after transfemoral TAVR requires “an entire clinical pathway,” explaining that “the key principles of a successful ‘minimalist’ approach are achieving optimized preprocedural, periprocedural, and postprocedural care for patients undergoing TAVI.”

Wood and Sathananthan’s group in Vancouver has developed such a pathway (which has evolved into the Benchmark Program from Edwards Lifesciences) that centers can adopt to achieve these goals and hit certain targets in their patients undergoing transfemoral TAVR. Those targets include rates of mortality, stroke, and vascular complications no higher than 1%, a next-day discharge rate of at least 80%, a 30-day readmission rate below 5%, and a permanent pacemaker rate of 5% to 6%.

Wood said the appetite among TAVR centers around the world to follow the minimalist approach has increased during the pandemic. “The amazing thing is people are so motivated over the last 5 or 6 months to do that because, as we all know, you can’t be taking up beds in the middle of a pandemic.” To be able to say that “these TAVI patients can come in safely, be admitted the day of the procedure, have a 20- or 30-minute procedure, and be in the room less than an hour, and more than 80% can go home the next day and more than 95% can go home within 48 hours, that completely changes the game,” he said.

Prior to COVID-19, training sites in the minimalist approach required multiday in-person visits, but Wood said that over the past several months, they’ve been activating sites virtually through video meetings. “That’s going to change not just how we do education and knowledge translation and proctoring, whatever you want to call it, during the pandemic,” he said. “I think that’s going to be a long-term change.”

A “silver lining” of the COVID-19 pandemic, Wood said, is that previous barriers to wider adoption of minimalist TAVR practices “have kind of melted away during the pandemic.” Patients with aortic stenosis, regardless of their surgical risk, have a high risk of major adverse outcomes in the short term, he noted. “We have the evidence, this study adds to it, that it is safe, and more importantly, it allows us to treat patients during a pandemic that otherwise might not be treated and would suffer very adverse outcomes or die.”