Transcatheter Pulmonary Valve Replacement With Sapien Prosthesis

Dec 08, 2020
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Authors:
Shahanavaz S, Zahn EM, Levi DS, et al.
Citation:
Transcatheter Pulmonary Valve Replacement With the Sapien Prosthesis. J Am Coll Cardiol 2020;76:2847-2858.
Summary By:
Bina Ahmed, MD, FACC

Quick Takes

  • This is the largest report of patients undergoing transcatheter pulmonary valve replacement (TPVR) using the Sapien device.
  • Treatment was associated with high technical success rates (97%).
  • Major complications occurred in 10% of patients and included need for urgent surgery, need for second implant, and tricuspid valve injury.

Study Questions:

What are short-term outcomes of patients who underwent transcatheter pulmonary valve replacement (TPVR) with a Sapien XT or S3 valve?

Methods:

Data were analyzed retrospectively from a multicenter registry for patients who underwent attempted TPVR with a Sapien XT or S3 valve. Patient-related, procedural, and short-term outcomes data were characterized overall and according to type of right ventricular outflow tract (RVOT) anatomy.

Results:

Twenty-three centers enrolled a total of 774 patients: 397 (51%) with a native/patched RVOT; 183 (24%) with a conduit; and 194 (25%) with a bioprosthetic valve. The S3 was used in 78% of patients, and the XT was used in 22%, with most patients receiving a 29-mm (39%) or 26-mm (34%) valve. The implant was technically successful in 754 (97.4%) patients. Serious adverse events were reported in 67 patients (10%), with no difference between RVOT anatomy groups. Fourteen patients underwent urgent surgery. Nine patients had a second valve implanted. Among patients with available data, tricuspid valve injury was documented in 11 (1.7%), and nine others (1.3%) had new moderate or severe regurgitation 2 grades higher than pre-implantation, for 20 (3.0%) total patients with tricuspid valve complications. Valve function at discharge was excellent in most patients, but 58 (8.5%) had moderate or greater pulmonary regurgitation or maximum Doppler gradients >40 mm Hg. During limited follow-up (n = 349; median 12 months), nine patients were diagnosed with endocarditis, and 17 additional patients underwent surgical valve replacement or valve-in-valve TPVR.

Conclusions:

Acute outcomes after TPVR with balloon-expandable valves were generally excellent in all types of RVOT. Additional data and longer follow-up will be necessary to gain insight into these issues.

Perspective:

This study reports outcomes among a large cohort of patients undergoing transcatheter pulmonary valve replacement using a ballon-expandable Sapien device. Highlights include high success rate (97%), serious complications including need for urgent surgery, need for second implant; tricuspid valve injury (3%) occurred in 10% of patients. Despite high procedural success rates, 58 patients had residual moderate or greater pulmonary regurgitation, nine developed endocarditis, and 17 needed repeat intervention in follow-up. Though these findings are exciting and encouraging, much work remains to optimize use of existing transcatheter platforms to treat the spectrum of pulmonic valve disease.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Cardiac Surgery and VHD, Interventions and Structural Heart Disease

Keywords: Cardiac Surgical Procedures, Endocarditis, Heart Valve Diseases, Heart Valve Prosthesis, Patient Discharge, Pulmonary Valve Insufficiency, Transcatheter Aortic Valve Replacement, Tricuspid Valve


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