Transfemoral TAVR Carries Similar Vascular Complication Risk With or Without Surgical Cutdown

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A fully percutaneous approach to transfemoral transcatheter aortic valve replacement (TAVR) yields a similar rate of vascular complications compared with procedures using surgical cutdown, according to a retrospective study published online July 15, 2014, ahead of print in Circulation: Cardiovascular Interventions. Moreover, the percutaneous-only method shortens the length of hospital stay.

Complication Rates the Same, Length of Stay Differs

Patients who received a fully percutaneous procedure had a shorter hospital stay (7.5 vs 9.9 days; P = .003) and a lower rate of major vascular complications at 30 days (11% vs 20%; P = .03). The most common complications in both groups were iliofemoral perforation/vascular damage and iliofemoral dissection. There was no difference in all-cause in-hospital mortality between the groups.

After propensity matching, the difference in major vascular complications disappeared, but the disparity in the length of hospital stay remained (table 1).

Table 1. Outcomes After Propensity Matching

Female Sex, Sheath Oversizing Tied to Complications

Multivariate analysis revealed 2 predictors of overall vascular complications:

•   Female sex (OR 2.2; 95% CI 1.1-4.3)

•  Sheath oversizing (per 1-mm increase in the difference between sheath outer diameter and minimal artery diameter; OR 1.4; 95% CI 1.1-1.8)

Sheath oversizing also doubled the risk of major vascular complications (OR 2.0; 95% CI 1.4-2.9).

When patients were divided into tertiles of sheath oversizing, the rate of overall vascular complications increased from 9% for those with the least oversizing to 31% for those with the most oversizing (P = .002), with similar trends seen for major vascular complications and length of stay.

“Naturally, with technological improvements, sheath size will continue to decrease, making vascular access complications with transfemoral TAVR less common overall,” the authors point out. “However, in the individual patient, even with reduced sheath sizes, our results indicate that careful preprocedure planning with respect to the relationship between [sheath outer diameter] and [minimal artery diameter] will continue to be warranted because this proves to be the strongest predictor of vascular complications.”

Although an individual case might warrant oversizing, Dr. Giri emphasized to TCTMD in a telephone interview, “There’s no such thing as a safe oversize.”

Percutaneous ‘the Preferred Approach’

Dr. Giri and colleagues observe that “no previous study has examined the association of the [fully percutaneous] and [open surgical] approaches with vascular complications in a wide cross section of patient risk groups with the full range of sheath sizes currently being used in the United States.”

Even so, Dr. Giri said in the interview that previous studies “are relatively consistent with what we’re saying.” Although none have found the percutaneous approach to be better in terms of reducing vascular complications, “the good news [here] is that… it’s not inferior,” he added.

The shorter hospital stay with the percutaneous approach combined with the lack of a difference in vascular complications makes the optimal choice of technique clear, Dr. Giri said.

“Our group feels that the percutaneous approach is the preferred approach when the preevaluation has revealed that both are good options,” he said. “The bottom line is that patients would prefer to leave faster, and it potentially decreases costs.”  

Caveat: Length of Stay for Surgical Cutdown Patients Has Improved

In a telephone interview with TCTMD, Josep Rodés-Cabau, MD, of Laval University (Quebec City, Canada), agreed that recovery can be faster with the percutaneous approach but pointed out a caveat to the interpretation of the difference in length of stay observed in the study.

Dr. Rodés-Cabau said he suspected that most of the patients in the open surgical group were treated in the early days of TAVR before the researchers switched to a predominantly percutaneous approach. Over time, the postoperative care of these patients has improved and that needs to be taken into account when looking at the length-of-stay data, he said.

Another consideration, Dr. Rodés-Cabau noted, is that the study operators are highly experienced in structural procedures, “so it probably has to be shown whether or not this is reproducible in centers with less experience and lower volumes.”

 Source:

Kadakia MB, Herrmann HC, Desai ND, et al. Factors associated with vascular complications in patients undergoing balloon-expandable transfemoral transcatheter aortic valve replacement via open versus percutaneous approaches. Circ Cardiovasc Interv. 2014;Epub ahead of print.

•  Dr. Rodés-Cabau reports serving as a consultant to Edwards Lifesciences and St. Jude Medical.  

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