Access Site Complications Often Related to Closure Failure in TAVR Procedures

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Vascular complications are not uncommon in patients undergoing transcatheter aortic valve replacement (TAVR) via the transfemoral route, reports an observational study published online July 23, 2012, ahead of print in the American Journal of Cardiology. Nearly two-thirds of such events are related to arteriotomy closure failure, with larger sheath size and female sex both predicting increased risk.

Investigators led by Nicolas M. Van Mieghem, MD, of Erasmus Medical Center (Rotterdam, The Netherlands), gathered data from the PRAGMATIC registry on access site complications in 986 patients treated at 5 experienced European centers from November 2005 to August 2011. All underwent TAVR via transfemoral access; device type was evenly split between CoreValve (Medtronic, Minneapolis, MN) and Sapien (Edwards Lifesciences, Irvine, CA). Endpoints were defined according to Valve Academic Research Consortium criteria.

Sheath Size, Gender Key Predictors

Overall, the rate of major vascular complications was 14%, while life-threatening/disabling bleeding occurred in 11% of patients and major bleeding in 18%. Bailout intervention was required in 12% of cases.

Major vascular complications were more common, however, in patients treated with sheath sizes larger than 19 Fr compared with smaller sheaths (22% vs. 12%; P < 0.001), as were bailout interventions (20% vs. 10%; P < 0.001). Major bleeding, meanwhile, happened more often in patients who underwent percutaneous rather than surgical access and closure (19% vs. 11%; P = 0.007).

Among the 81% of patients treated with an exclusively percutaneous strategy, closure device failure was responsible for 64% of major vascular complications and 29% of life-threatening/disabling bleeds.

On multivariable analysis, independent predictors of major vascular complications were female gender (adjusted OR 1.63; 95% CI 1.12-2.36) and sheath size greater than 19 Fr (adjusted OR 2.87; 95% CI 1.68-4.91). Life-threatening/disabling bleeding was also predicted by female gender (adjusted OR 2.04; 95% CI 1.31-3.17) and larger sheath size (adjusted OR 1.86; 95% CI 1.02-3.38) as well as by the presence of peripheral arterial disease (adjusted OR 2.14; 95% CI 1.27-3.61) and percutaneous access (adjusted OR 2.39; 95% CI 1.16-4.89).

Importantly, the learning curve had an effect on bleeding risk, with a decrease shown in the second half of patients treated as operators gained experience (adjusted OR 0.45; 95% CI 0.27-0.73). However, the learning curve had no significant effect on the likelihood of major vascular complications (adjusted OR 0.83; 95% CI 0.54-1.27).

Also on multivariate analysis, life-threatening/disabling bleeding strongly predicted 30-day mortality (HR 4.85; 95% CI 2.45-9.62) but the occurrence of major vascular complications did not (HR 1.24; 95% CI 0.60-2.56).

Progressing Toward a Smaller Profile

In an e-mail communication with TCTMD, Dr. Van Mieghem pointed out that the “study covered a wide time span so it was kind of expected that the incidence of access site complications [would] be at the higher end of what is presented nowadays.” The “most striking element,” he added, was that such a large portion of complications followed closure device failure, an unanticipated finding.

Dr. Van Mieghem characterized the relationship between sheath size and outcome as “reassuring,” in that the field is “on the verge of introducing 16-Fr and even 14-Fr device systems. So we can safely conclude that the number of vascular complications will only go down with technological refinements (smaller delivery systems) and more reliable closure device technologies.”

Overall, the findings represent “yet another argument that the TAVR procedure is becoming safer and may justify a shift to lower-risk patient populations where the stakes are higher and the competition with [surgical valve replacement] is fierce,” Dr. Van Mieghem concluded.

Josep Rodés-Cabau, MD, of Laval University (Quebec City, Canada), told TCTMD in a telephone interview that the findings confirm what is already known about TAVR-related complications but in a larger series. “When you’re talking about complication rates of 10% or higher, I think that we all agree this is an unresolved issue,” he said. “It’s an impossible dream to think that we will get even close to zero, but we should be lower than 10%. We should improve.”

Surgical access for TAVR is still a valid approach in borderline cases or those involving calcification, Dr. Rodés-Cabau added.

As the paper notes, “Undoubtedly, in selected cases (eg, heavily calcified peripheral arteries, focal atherolerotic disease, etc), surgical cutdown can offer superior arterial access control because of direct visualization of the target vessel during arteriotomy and closure.”

Tailoring TAVR to Women

Concerning women’s tendency to develop more complications, Dr. Van Mieghem noted that “The gender issue with invasive procedures is something we experience again and again whether it is in percutaneous coronary interventions or cardiac surgery. We know the iliofemoral vasculature has a smaller caliber in females. I think the issue of gender-related vascular complications will be less of an issue with smaller-profile systems.”

Sometimes operators “push the envelope” in women undergoing transfemoral TAVR, Dr. Rodés-Cabau noted, advising that alternative approaches should be considered for borderline cases.

Dr. Van Mieghem agreed. “With the growing experience of alternative access strategies, we have more treatment options. The local heart teams should decide which access strategy would fit best based on detailed multimodality imaging assessment of the upper and lower vascular tree (invasive angiography, [multislice] CT),” he noted, stressing “the importance of the ratio of sheath size to vessel diameter. Borderline iliofemoral trees should be avoided in favor of transapical, transaxillary, or direct aortic access [through a ministernotomy or minithoracotomy].”

‘No Substitute for Good Preparation’

In an e-mail communication with TCTMD, Ted Feldman, MD, of Evanston Hospital (Evanston, IL), said the study “is unique in terms of reviewing a large number of cases in a real world multicenter registry. Most prior reports represent selected cases from trials, or single-center reports. This report is large enough to give a clear picture of the frequency of vascular complications and to characterize the differences between early and late experience, and between surgical and percutaneous access and closure methods.”

According to Dr. Feldman, the “lack of observation of a learning curve effect [on vascular complications] is remarkable and may reflect the level of expertise of the participating centers.”

It is evident that “careful patient evaluation and selection was utilized to make decisions regarding [access strategy]. This highlights the general principle that there is no substitute for good preparation,” he noted, adding that without a comparison of bleeding rates among centers it is impossible to know whether operator or technique differences might be at work.

 

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Source:
Van Mieghem NM, Tchetche D, Chieffo A, et al. Incidence, predictors, and implications of access site complications with transfemoral transcatheter aortic valve implantation. Am J Cardiol. 2012;Epub ahead of print.

 

 

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