Early Discharge After Transfemoral TAVR Safe in Selected Patients
Early discharge after transfemoral TAVR is feasible and safe in patients without major complications, according to a study published online January 31, 2015, ahead of print in the American Journal of Cardiology. The results support the cost-effectiveness of the interventional procedure compared with surgery in selected patients, according to the authors.
Researchers led by Eric Durand, MD, PhD, of the University Hospital of Rouen (Rouen, France), retrospectively analyzed 337 patients who underwent transfemoral TAVR with the Sapien XT prosthesis (Edwards Lifesciences) and local anesthesia at their institution from October 2009 to November 2013. About one-third (n = 121) were discharged early (≤ 3 days), while the rest (n = 216) were discharged late (>3 days).
The early discharge group was less symptomatic and had less renal failure, A-fib, and previous balloon aortic valvuloplasty. Patients discharged late were less likely to have a preexisting pacemaker and had higher baseline creatinine. Also, procedural duration was shorter and contrast volume lower in patients with early discharge, but there were no differences in valve size and proportion of valve-in-valve procedures.
While those discharged early vs late were less likely to have residual regurgitation ≥ grade 2 (P = .03) on postprocedural echo, there were no differences in mean aortic gradient or LVEF. None of the patients in the early discharge group had stroke, life-threatening bleeding, acute MI, or acute kidney injury (AKI) stage 2-3 before discharge. Major bleeding/vascular complications and need for transfusions also was lower in the earlier discharge group.
Death/Rehospitalization Risk Similar With Early, Late Discharge
The combined rate of death and rehospitalization from discharge to 30 days (primary endpoint) was similar between the early and late discharge groups (3.3% vs 5.1%; P = .58), and no patients in the early group died. One of the 2 deaths in the late discharge group was attributed to life-threatening bleeding combined with AKI stage 3, while the other resulted from major stroke.
The proportion of patients readmitted within 30 days was low and similar between the groups, and none of the early discharge patients presented with delayed high-degree atrioventricular block.
Multivariable analysis identified preexisting pacemaker (adjusted OR 2.27; 95% CI 1.01-5.26) and absence of AKI (adjusted OR 0.99; 95% CI 0.98-0.99) as predictors of early discharge and previous balloon aortic valvuloplasty (adjusted OR 0.44; 95% CI 0.22-0.91) and postprocedural blood transfusion (adjusted OR 0.10; 95% CI 0.03-0.42) as predictors of late discharge.
A Reasonable Option for Many
There is no consensus on how long patients should be monitored after transfemoral TAVR, Dr. Durand and colleagues observe, noting that no prior studies have evaluated the feasibility and safety of early discharge.
“[E]arly discharge has emerged in our group as a reasonable option, considering the reduction of required sheath size, a careful selection of patients [that avoids] compassionate cases, and the growing experience of the operators,” they write. “Obviously, the occurrence of any major complication after [TAVR] as well as [procedures done] in hemodynamically unstable patients require prolonged recovery and do not allow [for] an early discharge.”
Additionally, the fact that most major complications after Sapien XT implantation occur within 48 hours further supports the acceptability of early discharge, according to the authors.
In a telephone interview with TCTMD, Peter C. Block, MD, of Emory University Hospital (Atlanta, GA), said his team has previously reported that most transfemoral TAVR patients can be safely released at 48 hours—a timeframe that applies to at least 60% of TAVR patients treated at Emory.
“These are all patients who… are done not with general anesthesia but with conscious sedation, so they are essentially awake the whole time and there’s never a question of having intubation and anesthesia in the room,” Dr. Block said, adding that smaller devices allow for the transfemoral approach to be “much more user-friendly for people who even have moderate peripheral vascular disease.”
As for valve type, he said there should be no difference in outcomes whether patients are treated with a Sapien valve or the CoreValve device (Medtronic). “[P]acemakers are more frequently needed after CoreValve insertion,” Dr. Block said. “But people are learning how to minimize pacemaker need in CoreValve patients as well. So everyone’s moving toward the same target, which is to get patients out quickly and not to [put] them asleep if possible.”
The authors conclude that a prospective study is needed to confirm their results.
Given that bleeding requiring transfusion most often leads to late discharge, Dr. Durand and colleagues suggest “careful selection of patients, smaller size devices, and avoiding a loading dose of clopidogrel before the procedure.”
Ultimately, TAVR could be “economically attractive” compared with surgery for transfemoral patients who can be safely sent home early, they say.
TAVR using local anesthesia “really saves in hospital costs because it takes patients out of the hybrid operating room and puts them in a cath lab,” which requires the presence of fewer healthcare professionals, Dr. Block said. “The more of this kind of thing that we can learn to do safely, the better we will be able to understand the costs vs the benefits and the actual reimbursements for transcatheter aortic valve replacement, which is a very tricky business.”
Since Medicare reimbursements for TAVR vary, Dr. Block explained, operators can potentially be financially penalized for “trying to get patients out of the hospital quickly, for example, to go to another facility.” However, this study represents “a major step forward in allowing us to think about getting patients out of the hospital quickly and… safely,” he concluded.
Durand E, Eltchaninoff H, Canville A, et al. Feasibility and safety of early discharge after transfemoral transcatheter aortic valve implantation with the Edwards Sapien-XT prosthesis. Am J Cardiol. 2015;Epub ahead of print.
The paper provides no statement regarding conflicts of interest for Dr. Durand.
Dr. Block reports no relevant conflicts of interest.
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Yael L. Maxwell is Senior Medical Journalist for TCTMD and Section Editor of TCTMD's Fellows Forum. She served as the inaugural…Read Full Bio