Small Study Supports Transaortic TAVR as Better Option Than Transapical

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Transcatheter aortic valve replacement (TAVR) by the transaortic route may result in less bleeding and fewer vascular complications than the transapical route, rendering the former technique preferable when a transfemoral procedure is not possible in inoperable patients with severe aortic stenosis. Results of a small study were scheduled for publication online April 9, 2013, ahead of print in the Journal of the American College of Cardiology.

Joel A. Lardizabal, MD, of the University of Miami Miller School of Medicine (Miami, FL), and colleagues looked at 44 patients with severe aortic stenosis who underwent transaortic TAVR at their institution between January 2012 and June 2012. These patients were compared with a cohort of 76 patients who received transapical TAVR between May 2009 and June 2012. All patients received a Sapien transcatheter heart valve (Edwards Lifesciences, Irvine, CA), and all had inadequate iliofemoral access.

All patients in the transaortic group were deemed inoperable, while most of the patients in the transapical group (87%) were eligible for surgical aortic valve replacement.

Acute technical success as defined by the Valve Academic Research Consortium (VARC) was similar in the transaortic (89%) and transapical groups (84%; P = 0.59). At 30 days, the VARC combined safety endpoint was also similar between the 2 groups, as were mortality and life-threatening/disabling bleeding. However, major bleeding and total bleeding/vascular complications were lower in the transaortic group (table 1).

Table 1. Thirty-Day Outcomes

 

Transaortic TAVR(n = 44)

Transapical TAVR
(n = 76)

P Value

VARC Combined Safety Endpointa

20%

29%

0.50

Mortality

14%

14%

1.00

Life-threatening and Disabling Bleeding

14%

13%

1.00

Major Bleeding

11%

28%

0.04

Total Bleeding and Vascular Complications

27%

46%

0.05

a VARC combined safety endpoint: all-cause mortality, major stroke, disabling bleeding, severe acute kidney injury, postprocedure MI, major vascular complication, and repeat procedure for valve-related dysfunction.

The authors note that 28% of transapical patients showed significant blood loss during access site closure, while a 61% relative reduction in perioperative blood transfusion was demonstrated in transaortic patients. 

In addition, median ICU stay was halved in the transoartic group (3 days vs. 6 days; P = 0.01); transaortic patients also showed a trend for shorter median length of hospital stay (8.0 days vs. 10.0 days; P = 0.14).

Learning Curve Not as Steep for Transaortic

To investigate the learning curve for both procedures, the study authors compared the first 20 cases with subsequent cases in the transaortic and transapical groups. The rate of procedural adverse events did not change between the first 20 (15%) and subsequent cases (14%) in the transapical group (P = 1.00). However, such complications did not occur at all after the first 20 cases in the transaortic group (20% vs. 0%; P = 0.04), “suggesting a more favorable technical learning curve,” according to the authors.

Other outcomes such as technical device success, 30-day mortality, and 30-day VARC safety did not change between the early and later experience in either group.

“TAVR via the [transaortic] approach, using the commercially-available device in the [United States], is technically feasible and appears to be associated with favorable outcomes in inoperable patients with severe [aortic stenosis] who are not candidates for [transfemoral] access,” the authors conclude. “The [transaortic] approach expands the current alternative options for TAVR access sites, and development of a dedicated delivery platform is recommended to further improve its efficacy and safety.”

Dr. Lardizabal and colleagues note that the study, the largest cohort of patients to undergo transaortic TAVR in the United States, was performed without the newer-generation Sapien XT valve and delivery system (Ascendra-2, Edwards), which are commercially available in Europe but not the United States.

In addition, the authors’ transaortic TAVR program was halted after the implementation of the 2012 Medicare national coverage determinations for TAVR, limiting reimbursement to transfemoral procedures.

Data Make Sense

In a telephone interview with TCTMD, Brian K. Whisenant, MD, of the University of Utah (Salt Lake City, UT), called the reductions in bleeding and vascular complications and ICU stay seen with the transaortic group “clinically meaningful.” He added that “it makes sense because the apex has bleeding complications, and that’s one of the real limits [of transapical TAVR], but this is the first [study] I’ve seen that shows you can reduce those.”

Dr. Whisenant noted that transaortic access allows for a more controlled procedure. “When you’ve got that sheath in the apex, it tends to fall apart and cause more vascular damage because it’s muscle and unstable, and it’s a beating heart. People want to keep their sheath time very short in the apex,” he said. “When you’ve got an aorta, it’s a much more stable position and there’s not quite the sense of urgency.”

Dr. Whisenant added that the observed differences in the learning curve also make sense. “There is a learning curve with the transaortic procedure, but it seems like particularly when you get past the learning curve it’s a very safe procedure,” he said. “The transapical procedure has these inherent complications that will probably never go away.”

Additional key data should come with the PARTNER 2 trial, “but eventually we ought to have an FDA approved indication for transoartic delivery, I think that’s where it’s heading,” Dr. Whisenant said. “In the PARTNER 2 trial people are probably thinking about transapical first and reserving transaortic for patients who for some reason aren’t indicated for transapical procedures, whether that’s because of chronic lung disease or frailty. But I wonder if that’s moving the other way around, where people are going to start thinking transaortic first and reserving transapical for patients who aren’t great transaortic candidates because of aortic disease or other issues. I’m not really sure, but I think they’re compelling data.”

 


Source:
Lardizabal JA, O’Neill BP, Desai HV, et al. The transaortic approach for transcatheter aortic valve replacement: Initial clinical experience in the United States. J Am Coll Cardiol. 2013; Epub ahead of print.

 

 

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Disclosures
  • Drs. Lardizabal and Whisenant report no relevant conflicts of interest.

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