Studies Show Valve-in-Valve TAVR Successful for Failed Surgical Bioprostheses

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Two studies add further support for valve-in-valve transcatheter aortic valve replacement (TAVR) to treat failed surgical aortic bioprostheses. Both studies, published in the November 2011 issue of JACC: Cardiovascular Interventions, show high rates of procedural success and good functional outcomes.

In the first study, researchers led by Holger Eggebrecht, MD, of the University of Duisburg-Essen (Essen, Germany), and colleagues report data on 47 patients undergoing transfemoral (n = 25) or transapical (n = 22) valve-in-valve TAVR for failed bioprosthetic aortic valves at 9 sites in Germany and Switzerland.

Most patients were severely symptomatic, with 96% of them in New York Heart Association (NYHA) functional class III or higher prior to TAVR. The mode of failure prompting need for TAVR was stenosis (47%), regurgitation (32%), or a mixture of both (21%). The Sapien or Sapien XT devices (Edwards Lifesciences, Irvine, CA) were used in 75% of patients, with the remaining patients receiving the CoreValve Revalving System (Medtronic, Minneapolis, MN).

Patient mean age was 80.3 ± 7.1 years, and mean logistic EuroSCORE was 35.0 ± 18.5%. At baseline, the mean gradient across the bioprosthesis was 38 ± 15 mm Hg, and the valve orifice area was 0.90 ± 0.42 cm². Bioprostheses had been implanted surgically a mean of 113 ± 65 (range, 9 to 261) months before the valve-in-valve TAVR procedure.

High Success, Acceptable Mortality

The technical success rate was 100%, with at least 1 stent valve successfully implanted into the failed surgical bioprosthesis. In addition, implantation height of the stent prosthesis within the bioprosthesis was judged as “ideal” by the operator in 92% of cases.

One death occurred during the procedure as a result of refractory low-output cardiac failure. Procedural complications occurred in 9 patients (19%) and predominantly consisted of vascular access complications.

After implantation, the mean transvalvular gradient was significantly reduced to 17 ± 10 mm Hg, whereas the aortic valve area was increased to 1.61 ± 0.47 cm² (P < 0.001 vs. baseline). However, 44% with available data on transvalvular gradients after the procedure had increased mean transvalvular gradients ≥ 20 mm Hg.

With respect to valve competence, none or only mild regurgitation was observed in 98% at the end of the procedure, with no case of moderate or severe regurgitation.

During the in-hospital period, 16 patients (34%) developed additional complications. New permanent pacemaker implantation was performed in 5 patients (11%). The rate of new pacemaker implantation was nonsignificantly higher in patients undergoing CoreValve implantation compared with those undergoing Sapien valve implantation (33% vs. 6%; P = 0.109).

The 30-day mortality rate was 17% (including the 1 procedural death). Of these 8 deaths, 5 were cardiac related and occurred in patients treated transapically while the remaining 3 involved infectious or septic complications.

According to Dr. Eggebrecht and colleagues, the multicenter data extend the findings of previous single-center reports supporting the feasibility and high rate of success for valve-in-valve TAVR in ‘real-world’ clinical practice.

“The already existing efforts at improving technology along with better postoperative management are likely to improve the future outcomes of [valve-in-valve TAVR] in this high-risk patient population,” they add.

More Valve-in-Valve Affirmation with CoreValve

In the second study, Luca Testa, MD, PhD, of Istituto Clinico Sant'Ambrogio (Milan, Italy), and colleagues report on 25 high-risk patients with a failed surgical bioprosthesis who underwent valve-in-valve TAVR with the CoreValve Revalving System, 22 by a transfemoral approach and 3 via axillary access. Patients/prostheses were divided into 2 groups: mainly stenotic (n = 9) and mainly regurgitant (n = 16).

The mean age of patients was 82.4 ± 3.2 years, with a mean logistic EuroSCORE of 31.5 ± 14.8%.

Like the German researchers, the Italian group reports an implantation success rate of 100%. In the stenotic group, peak transaortic gradient decreased from 77.6 ± 21.6 mm Hg to 34.6 ± 19.4 mm Hg (P = 0.001). Valve area increased nonsignificantly, and there was no significant change in left ventricular ejection fraction post procedure.

In the regurgitant group, the peak transaortic gradient significantly decreased from 36.8 ± 22.4 mm Hg to 20.2 ± 7.2 mm Hg (P = 0.01). In all but 2 patients in this group, no significant regurgitation was observed post-implantation, and LVEF did not improve.

Overall, no deaths occurred during the procedure. The mortality rate at 30 days was 12%.

By mean follow-up of 6 months, an additional death occurred as a result of severe respiratory insufficiency and a pacemaker implantation for a new complete atrioventricular block was required. However, there were no additional strokes, MIs, major bleeds, or repeat valve interventions. The mortality rate at 60 days was 16%. The need for pacemaker implantation at that time also was 16%.

Echocardiographic parameters at last follow-up showed a persistent good result after valve implantation and improvement in NYHA functional class in all patients to class I or II.

“In centers with expertise in [CoreValve Revalving System]-TAVI in native stenotic aortic valves, valve-in-valve implantation for failed aortic bioprostheses is feasible and effective, with good valve performance and symptom improvement persisting at midterm,” the study authors write.

“Moreover, [CoreValve Revalving System]-TAVI, which was introduced for the treatment of stenotic aortic valves, proved effective, even in those patients with predominantly regurgitant xenografts,” they add.”

Dr. Testa and colleagues further suggest that their data serve as a proof-of-concept, “which may significantly affect the treatment of patients with a failed aortic bioprosthesis, still considered an off-label indication, deemed at prohibitive risk for a surgical redo.”

  

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Sources:
1. Eggebrecht H, Schäfer U, Treede H, et al. Valve-in-valve transcatheter aortic valve implantation for degenerated bioprosthetic heart valves. J Am Coll Cardiol Intv. 2011;4:1218 1227.

2. Bedogni F, Laudisa ML, Pizzocri S, et al. Transcatheter valve-in-valve implantation using CoreValve Revalving System for failed surgical aortic bioprostheses. J Am Coll Cardiol Intv. 2011;4:1228-1234.

 

 

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