Registry Studies Focus on Different TAVR Access Routes

SAN FRANCISCO, CALIF.—New data from the UK TAVI Registry demonstrate a lower patient risk profile for patients undergoing transfemoral TAVR compared with the transapical and subclavian routes.

Daniel J. Blackman, MD, of Leeds General Infirmary in the United Kingdom, presented outcomes of TAVR according to valve type and access route using data from the large-scale UK TAVI Registry. The researchers examined 1,620 procedures performed from January 2007 through December 2010 (50-50 split between Core

Valve and Sapien). The majority of valves were implanted by the transfemoral route. More than half of the Sapien implants (Edwards Lifesciences) were transapical, in contrast to almost 90% of CoreValve implants (Medtronic) performed by the transfemoral route.

Mortality at 30 days was significantly higher in patients undergoing transapical TAVR (Sapien: 11.2%) vs. the transfemoral (CoreValve: 5.2%; Sapien: 4.3%) and subclavian (CoreValve: 4.4%) approaches (P<.001). Further, at 1 year, both transapical (74.5%) and subclavian (75.4%) TAVR approaches were associated with lower survival when compared with the transfemoral approach (Sapien: 84.5%; CoreValve: 80.8%).

Outcomes such as major vascular complications and blood transfusions were higher with apical and subclavian TAVR compared with femoral (see Figure 1).Registry Studies Figure 1

Overall patient risk was higher with the apical and subclavian routes

Mean logistic EuroSCORE also was significantly higher with transapical (21) and subclavian (22) TAVR compared with transfemoral TAVR (Sapien: 16; CoreValve: 17; P<.001).

As described in the initial publication of the UK TAVI Registry data, Blackman said the incidence of aortic regurgitation >2 was more frequent in patients undergoing transfemoral TAVR (Sapien: 8.4%; CoreValve: 13.4%) than transapical (6.4%) or subclavian (9.5%) TAVR, with the trend favoring CoreValve. Need for permanent pacing was also greater with CoreValve, irrespective of access route (transfemoral: 21.6%; subclavian: 22.1% vs. Sapien transfemoral: 6.2%; Sapien transapical: 5.6%).

The researchers also observed a similar learning curve with the three major access routes that improved over time from 2007 to 2010.

Blackman said these outcomes compare favorably with the published UK TAVI Registry series.

CoreValve subclavian registry

Also at the featured clinical research session, Anna Sonia Petronio, MD, presented 2-year results of a single-center, propensity-case-controlled registry of subclavian vs. transfemoral TAVR.

“The subclavian approach is a safe alternative with similar early- and long-term results compared to the femoral approach,” Petronio, of the University of Pisa in Italy, concluded.

Registry Studies Figure 2

In the study, the subclavian approach was used in 141 consecutive patients. This group was propensity score matched with a control group of 141 patients who underwent TAVR via the transfemoral approach. Procedural success rate was 98% for subclavian and 95% for transfemoral. According to an abstract that accompanied the presentation, Petronio and colleagues reported that device success was 96.5% vs. 97.9% in the transfemoral vs. subclavian groups (P=.47), with intraprocedural mortality of 1.4% vs. 0.7% (P=.56). The rate of suboptimal CoreValve deployment was 13.5% with the subclavian approach vs. 14.2% with the transfemoral approach (P=.81). The learning curve for the subclavian approach lead to a lower use of general anesthesia after the first four cases (from 74.4% to 44.9%; P=.001); this did not affect procedural success and duration.

Overall, survival at 2 years was 74.6% with the subclavian approach vs. 72.1% with the transfemoral approach (P=.72). Freedom from cardiac death was similar between the transfemoral and subclavian approaches (88.7% vs. 87.1%; P=.82) and freedom from MACCE was also similar (82.3% for both groups; P=.57).

Common in-hospital complications observed with both the subclavian and femoral approaches included new left bundle branch block and the need for pacemaker. Rate of acute renal failure was higher with the femoral approach, while the incidence of major and minor vascular complications was similar in the two groups. However, the subclavian approach was more effective in guaranteeing a reduction in bleeding related to the vascular access, according to Petronio (see Figure 2).

  • Dr. Blackman reports serving as a proctor for Medtronic.
  • Dr. Petronio reports receiving consulting fees from Medtronic.