Study Supports Safety of Forgoing ICU Stay After TAVR in Selected Patients


Confirming what has become common practice, a single-center study shows that TAVR can be performed safely without the need for admission to the intensive care unit (ICU) in a subset of patients selected on the basis of simple clinical, electrocardiographic, and transthoracic echocardiographic criteria.

The take home.   Study Supports Safety of Forgoing ICU Stay After TAVR in Selected Patients

Roughly one-third of patients (34.5%) were classified as low risk and skipped the ICU after the procedure; only one of those patients had a complication, which was deemed minor, Florence Leclercq, MD, PhD (Arnaud de Villeneuve Hospital, Montpellier, France), and colleagues report online ahead of print in the American Journal of Cardiology.

The rest of the patients were considered high risk and were transferred to the ICU post-TAVR. Roughly one-quarter of them (26.7%) had clinical events, mostly conductive disorders requiring permanent or transient pacing.

“Combined with the possibility of early discharge, this ‘minimalist’ approach of [TAVR] may optimize efficiency and cost-effectiveness of the procedure,” the authors write.

In recent years, improvements in operator experience, valve technology, and patient selection, as well as a trend toward treating lower-risk patients, have resulted in a marked reduction in complications associated with TAVR. Because of this, and to accommodate larger numbers of patients, centers have begun triaging lower-risk patients to non-ICU recovery areas.

Triage Strategy Has High Negative Predictive Value

To assess the safety and feasibility of doing so at their center, Leclercq and colleagues prospectively looked at outcomes among 177 consecutive patients who underwent TAVR between December 2014 and July 2015, excluding patients who underwent valve-in-valve procedures or TAVR via transaortic or transapical access. All patients were not considered to be candidates for surgical valve replacement after an assessment by the Heart Team.

The balloon-expandable Sapien 3 valve (Edwards Lifesciences) was used in 83.6% of patients, with the rest receiving the self-expanding CoreValve prosthesis (Medtronic). The vast majority of the procedures involved transfemoral access (94.4%) and general anesthesia with orotracheal intubation (96.1%).

Before the procedure, 42.9% of patients were classified as high risk and were destined for the ICU regardless of how the procedure went, mostly due to an LVEF below 40%, the decision to use the CoreValve prosthesis without a previous pacemaker in place, or complete right bundle branch block. During and up to 2 hours after the procedure, another 22.6% of patients converted from low to high risk because of the occurrence of complications requiring ICU transfer, mostly new conductive disorders. Thus, 65.5% of patients were classified as high risk for the analysis.

The remaining low-risk patients were monitored in an anesthesia recovery room for 2 hours after the procedure and were then admitted to a conventional cardiology unit.

Overall, 32 patients had at least one clinical event; all but one were in the high-risk group. The lone low-risk patient had a noncompressive pericardial effusion that was considered minor. The patient was temporarily transferred to the ICU, but returned to the conventional unit after 12 hours.

“Considering our selection criteria, patients admitted to [the conventional cardiology unit] . . . can be managed safely without any major complication and, therefore, the negative predictive value of this triage strategy was very high (98.4%),” the authors note.

Of the 31 high-risk patients who had events, 26 developed conductive disorders requiring permanent or transient pacing. Major vascular complications or bleeding were seen in only two, although one died due to major bleeding.

Length of stay did not differ based on risk assessment, but patients who developed a complication had a longer average stay compared with those who did not (5.4 vs 3.7 days; P < 0.001).

Tailoring Post-TAVR Care Based on Risk Level is Essential

Leclercq et al point out that recent studies have shown that early discharge after TAVR—made possible at least partly by avoidance of the ICU—is feasible, safe, and cost-effective in patients selected based on criteria similar to those used in the current study.

Considering the trend toward using TAVR in lower-risk patients, they add, an increasing number of patients going to the ICU “may be a crucial problem, particularly in high-volume centers, because the number of critical care beds is limited.”

Commenting on the study for TCTMD, Isaac George, MD (NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, NY), pointed out that ICU admission is no longer the standard of care for high-volume TAVR centers.

“For high-volume centers, it is imperative to be able to triage TAVR patients appropriately to the level of care required; excessive care as well as insufficient care can each lead to its own set of problems,” he said in an email. “At our center, we allow fast track for low-risk patients with similar criteria to a 4-hour recovery area, [which is] then followed by the floor in up to 40% of patients. In centers with limited ICU resources, this strategy is a must to accommodate higher volumes.”

The current study, George said, shows that patients who undergo uncomplicated TAVR can safely avoid the ICU.

“The findings are similar to anecdotal reports for fast-track recovery, but also highlight the importance of conduction disturbance as a limiting procedural factor for early-discharge TAVR,” he added. “Whether this should influence the choice of valve device is a matter of great debate.”

The study also raises other questions, he said, including whether longer-term outcomes are similar when comparing a minimalist approach with standard monitoring; whether lower-risk patients should undergo a more invasive procedure involving transesophageal echocardiography and general anesthesia to obtain an optimal result at the cost of a longer hospital stay; and how best to manage warfarin-treated patients who are otherwise low risk.

“For now, minimalist procedures and their outcomes have to be carefully adjudicated, and these study findings can only be applied to high-risk patients,” George said. “A minimalist strategy needs to be independently studied in a randomized trial for [patients at] each level of risk.”

 


 

 

 

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Sources
  • Leclercq F, Iemmi A, Lattuca B, et al. Feasibility and safety of transcatheter aortic valve implantation performed without intensive care unit admission. Am J Cardiol. 2016;Epub ahead of print.

Disclosures
  • Leclercq did not make any statement regarding conflicts of interest.
  • George reports no relevant conflicts of interest.

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