Registry Data Show Low Complication Rates With Open Surgical Access for Transfemoral TAVR

Open surgical access can be used regularly for transfemoral TAVR in intermediate-risk patients without resulting in high rates of vascular or bleeding complications, according to a study published online August 17, 2015, ahead of print in the American Journal of Cardiology. The strategy may be advantageous in patients at high bleeding risk.

Florence Leclercq, MD, PhD, of the University Hospital of Montpellier (Montpellier, France), and colleagues analyzed data on 396 consecutive patients (median age 85 years; 55% women) who underwent transfemoral TAVR with exclusive use of open surgical access at their center between January 2010 and February 2014. Median logistic EuroSCORE was 15.2%.

All procedures were preceded by balloon aortic valvuloplasty and done using 16- to 20-Fr sheath systems under general anesthesia. Most patients (73.2%) received the balloon-expandable Sapien XT valve (Edwards Lifesciences) and the rest received the self-expanding CoreValve (Medtronic). Median procedure length was 68 minutes, which included 13 minutes for open surgical access.

As defined by Valve Academic Research Consortium (VARC)-2 criteria, the rates of major and minor vascular complications at 30 days were 2.3% and 4.0%, respectively. Surgical or percutaneous management of a complication was required in 2.3%.

Major vascular complications included 5 dissections, 2 hematomas, a false aneurysm, and a thoracic aortic dissection. Minor complications consisted of 13 hematomas and 1 case each of fistula, dissection, and femoral artery thrombosis.

Nonvascular complications at the access site that were deemed related to the surgical approach occurred in 7 patients—1 hematoma infection and 2 cases each of lymphocele, lymphorrhea, and scar dissension.

According to Bleeding Academic Research Consortium (BARC) definitions, 4.6% of patients had life-threatening or major bleeding and 3.3% had minor bleeding. Transfusions were required in 13.7% of patients, but 81.5% of those involved only a single unit of red blood cells.

Median length of stay was 5 days, although it was longer in patients who had vascular complications (7 days; P < .001).

Mortality at 30 days and 1 year was unrelated to vascular complications. The need for transfusion was not associated with 1-month mortality (P = .7) but did correlate with 1-year mortality (P = .02). On multivariate analysis, the only predictors of vascular complications were diabetes (OR 2.5; 95% CI 1.1-6.1) and chronic kidney failure (OR 3.0; 95% CI 1.0-9.0).

Better Control of Complications?

Earlier TAVR studies, which were conducted with first-generation devices and without the use of standardized definitions, reported vascular complication rates ranging from 8% to 31%. More recent studies using modified VARC-2 criteria have suggested that those rates have fallen due to the development of newer devices and smaller delivery systems, improved patient screening, and greater operator experience, Dr. Leclercq and colleagues note. Nonetheless, major vascular complications continue to be relatively common after TAVR.

Fully percutaneous access has been adopted in some centers, but the open surgical approach is still used in many hospitals, the investigators report. Which approach is better continues to be debated, but at least 1 recent study suggests that vascular complication risk is similar with the 2 strategies.

“The [open surgical] approach may have been viewed as more predictable, offering more direct control during adverse events,” the authors write. “Conversely, the [percutaneous approach] is considered as less invasive, especially with the use of small-diameter sheaths, and [is] associated in some studies with significantly lower postprocedural length of stay than the surgical route.”

Exclusive use of open surgical access may have resulted in the low rates of complications seen here for several reasons, according to Dr. Leclercq and colleagues. The technique, which is simple for a vascular surgeon and can be done relatively quickly, enables choice of the best location in the artery for cannulation, thereby decreasing the risk of dissection, they say.

In addition, when a vascular complication occurs, “it may be controlled and repaired more easily and more rapidly than with the [percutaneous] approach and the prognosis is probably better,” they say. “The low rate of major bleeding observed in our study is probably the result of this better control of [vascular complications].”

And there does not appear to be a penalty to pay in terms of length of stay, as patients undergoing transfemoral TAVR with open surgical access are able to stand up the day after the procedure, similar to those who undergo the intervention with fully percutaneous access, the authors say. They point out that “the median duration of hospitalization in our study (5 days) compared favorably to recent reports.”

Open surgical access can even be used as more centers begin using a “minimalist” TAVR strategy that involves local anesthesia and earlier discharge, particularly for patients with a high bleeding risk, such as women and those with extreme body mass indexes, Dr. Leclercq told TCTMD in an email.

Superiority Claims Unfounded

The low rate of vascular complications observed in the current study does not support the superiority of open surgical access over fully percutaneous access “given the lack of a comparator group as well as the absence of key procedural covariates that are known to drive vascular complication risk, such as the sheath outer diameter-to-minimal artery diameter ratio,” Jay S. Giri, MD, MPH, of the Hospital of the University of Pennsylvania (Philadelphia, PA), told TCTMD in an email. Additionally, procedures were performed by experienced operators.

“It is reasonable to believe that with the use of current-generation low-profile TAVR delivery systems in patients who undergo careful vascular access planning, similar results could be expected from a wide range of high-volume operators regardless of access approach,” he said.

Other studies have shown that vascular complication rates do not differ between the open surgical and percutaneous approaches, although the latter has been consistently associated with shorter lengths of stay, Dr. Giri pointed out.

Isaac George, MD, of Columbia University Medical Center (New York, NY), said the percutaneous approach has numerous other benefits.

“It eliminates the need for excessive analgesia, which can prolong hospital stay (as was evident in this study),” he told TCTMD in an email. “It allows more early mobilization without concern for wound breakdown. There is a significantly lower risk of wound infection. Patients greatly prefer not having an incision. Finally, by doing a completion angiogram, the vessel can be evaluated for injury prior to completion, [a process that] largely mitigates major vascular issues if done properly.”

Dr. George acknowledged that the complication rates seen in this study are lower than those in the original PARTNER data, but said the difference is most likely due to reductions in sheath size and not to the open surgical approach.

“An open cutdown is an unnecessary and outdated practice,” he concluded. “There are questionable benefits which are not fully substantiated in this paper and unfortunately, this paper provides no useful information for practicing physicians, reflecting TAVR practice from over 5 to 8 years ago when larger sheath sizes greater than 20 Fr where common.”

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Source: 
Leclercq F, Akodad M, Macia J-C, et al. Vascular complications and bleeding after transfemoral transcatheter aortic valve implantation performed through open surgical access. Am J Cardiol. 2015;Epub ahead of print.

Related Stories:

• Transfemoral TAVR Carries Similar Vascular Complication Risk With or Without Surgical Cutdown
• Fewer Vascular Complications as TAVR Evolves
• PARTNER Analysis: Vascular Complications Common in Transfemoral TAVR