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Performing transcatheter aortic valve replacement (TAVR) with only local anesthesia under fluoroscopic guidance is feasible and safe in high-risk surgical patients with severe aortic stenosis, according to a study published online May 9, 2012, ahead of print in JACC: Cardiovascular Interventions.

For the single-center, prospective study, Hélène Eltchaninoff, MD, of the University of Rouen (Rouen, France), and colleagues looked at 151 consecutive patients who underwent TAVR via transfemoral access with either the Sapien (n = 78; Edwards Lifesciences, Irvine, CA) or the Sapien XT (n = 73; Edwards Lifesciences) prostheses using local anesthesia (lidocaine 2%; 20-30 mL) and fluoroscopic guidance from May 2006 to January 2011.

The primary endpoint (composite of all-cause mortality, major stroke, life-threatening bleeding, stage 3 acute kidney injury [AKI], periprocedural MI, major vascular complication, and repeat procedure for valve-related dysfunction at 30 days), was similar between the 2 device groups (table 1).

Table 1. Thirty-Day Safety Outcomes

Overall procedural success was 95.4% (93.6% with Sapien vs. 97.3% with Sapien XT; P = 0.28). Five Sapien cases (3.3%) had to be converted to general anesthesia due to complications. Two of these patients (aortic dissection and annulus rupture) did not survive surgery, whereas the other 3 patients had uneventful outcomes. There were no cases of conversion to general anesthesia or surgery in the Sapien XT group. Vasopressors were required in 7 patients (5.5%).

Secondary endpoints, including NYHA functional class, hemodynamic parameters, aortic valve area, and mean valvular gradient, improved in both device groups. Moderate-to-important aortic regurgitation was infrequent.

A ‘Valuable Alternative’

In an e-mail communication with TCTMD, Dr. Eltchaninoff said that her team has been performing TAVR with local anesthesia since 2002, so they were not surprised by the findings.

“We [inferred] that it was not painful when using local anesthesia, that hemodynamics were stable, and thus there was no need for general anesthesia,” she wrote. “In our experience, our simplified strategy is feasible and safe. It makes the procedure simpler and faster.”

The authors emphasize that the invention of smaller sheath sizes has enabled local anesthesia with conscious sedation to become a “valuable alternative.”

In an accompanying editorial, Danny Dvir, MD, of Washington Hospital Center (Washington, DC), and colleagues, agree.

“The minimalist approach of local anesthesia and [conscious sedation] is obviously attractive in frail, elderly, high-risk patients,” they write. “It is assumed that when using minimal amounts of sedative agents, the hemodynamic effects attributable to these drugs will be minimal as well.”

Expert Hands Make the Difference

However, they acknowledge that anesthetic management of TAVR patients has been a “subject of controversy.” Because most of the important trials and registries have not provided data on sedation techniques, little is known about which method is best.

“[I]t is difficult to make an informed evidence-based choice about the best anesthetic management practice in this group of patients,” Dr. Dvir and colleagues write. Also, because all of the data published on this topic have come from nonrandomized trials, they should be viewed as “‘hypothesis generating’ only.”

In an interview with TCTMD, Philippe Généreux, MD, of Columbia University Medical Center (New York, NY), added that using local anesthesia and a simplified approach without transesophageal echocardiography (TEE) as an adjunct tool for valve positioning could negatively affect patients, especially in the hands of beginner operators.

“With TEE, you can optimize the result of the valve implantation and change the outcomes,” he said. “If you didn’t have it, you would question yourself and maybe you won’t even find the answer. The major complications happen about 3% to 5% of the time, but you need to be able to react fast and that reaction time can change everything for the patients.”

He continued that while positive results with the simplified technique show advancement in TAVR evolution, clinicians should be cautious about assimilating this into practice at the current time. Because the majority of TAVR centers in the United States are so new, Dr. Généreux said he would expect it to take at least 2 to 3 years before TAVR is performed routinely with local anesthesia in this country.

“At the beginning [of learning to perform TAVR], you want to be in total control. This study shows that it’s feasible, which is great. But it’s feasible and safe in expert hands, and that’s the message,” he said, adding that some experienced US centers could probably perform TAVR in this manner now, but may be reluctant to do so because of the PARTNER mandate to use TEE in all cases.

“It’s doable, but you run the risk of missing complications or not optimizing the procedure as much as you should,” he said, emphasizing that an anesthesiologist and general anesthesia equipment should be on stand-by in case of an emergency during the procedure.

Dr. Généreux suggested using intracardiac echocardiography or other adjunctive imaging modalities for the current optimization of TAVR. Also, a smaller TEE with a pediatric probe could potentially make conscious sedation possible without compromising safety, he said.

Study Details

The mean logistic EuroScore for all patients was 22.8 ± 11.8%, and was significantly lower in the Sapien XT group compared with the Sapien group (17.4 vs. 27.8%, P< 0.0001). A history of MI, CABG, balloon aortic valvuloplasty, and chest irradiation were less frequent in the Sapien XT group. All other variables were similar between the 2 groups. Procedural duration was markedly shorter in the Sapien XT group, whereas contrast volume was greater due to additional use of contrast associated with the “pre-close” technique.

2. Dvir D, Jhaveri R, Pichard AD. The minimalist approach for transcatheter aortic valve replacement in high-risk patients. J Am Coll Cardiol Intv. 2012;Epub ahead of print.

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• French Registry Provides Window into Real-World TAVR Use 
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• Comprehensive French TAVI Registry Shows Promising Results

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