Sapien Valve Keeps Delivering in Jobs for Which It Was Not Designed

We recently published the success of balloon-expandable Sapien valve when used as mitral valve replacement. We now hear about its success as pulmonary valve replacement.

válvula Sapien en posición pulmonar

Previous experiences with this prosthesis for aortic valve replacement have encouraged many operators to attempt fixing other valves. At first, there were exceptional cases considered compassionate treatments. However, experience has accumulated and lead to papers being published.

The acute outcome of pulmonary valve replacement with the Sapien valve is excellent in all types of right ventricular outflow tract, although more cases and longer follow-up are still needed.

There are limited papers on pulmonary valve replacement with Sapien XT or Sapien 3.

Data were collected retrospectively and included in a large multicenter registry of patients who received the XT or S3 as pulmonary valve replacement. Patient and procedure characteristics were analyzed, and so were the short term results, according to the type of right ventricular outflow tract anatomy.


Read also: Sapien 3 Performs Well in “Jobs” for Which It Is Not Designed.


Analysis included 774 patients: 397 (51%) with a native or patched outflow tract, 183 (24%) with a conduit, and 194 (25%) with a bioprosthetic valve.

Sapien 3 was used in 78% of patients, and the remainder received the XT model. Most also received the valve with the biggest diameter (29 mm).

Adverse events were reported in 10% of the population, with no difference between outflow tract anatomy.

About 14 patients underwent emergency surgery, and 9 had a second valve implanted. In 1.7% of cases tricuspid valve injury was documented, and 1.3% of patients had new moderate to severe pulmonary regurgitation not present before implantation.


Read also: Balloon-Expandable Valve Outdoes Itself.


The vast majority of patients was discharged with an excellent valve function, but 8.5% had moderate or greater pulmonary regurgitation or a >40 mmHg gradient.

Median follow-up was 12 months. During follow-up, about 9 patients were diagnosed with endocarditis and 17 underwent surgery or received a new transcatheter replacement.

Conclusion

The short term results for balloon-expandable valve implantation as pulmonary valve replacement are very good in all types of right ventricle outflow tract anatomy.

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Original Title: Transcatheter Pulmonary Valve Replacement With the Sapien Prosthesis.

Reference: Shabana Shahanavaz et al. J Am Coll Cardiol 2020;76:2847–58.  


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