Early outcomes of pulmonary valve replacement with the mitroflow bovine pericardial bioprosthesis

Sarah A Schubert; John L Myers; Allen R Kunselman; Joseph B Clark

doi:10.1016/j.athoracsur.2014.12.081

Early outcomes of pulmonary valve replacement with the mitroflow bovine pericardial bioprosthesis

Ann Thorac Surg. 2015 May;99(5):1692-8; discussion 1698-9. doi: 10.1016/j.athoracsur.2014.12.081. Epub 2015 Mar 25.

Authors

Sarah A Schubert¹, John L Myers², Allen R Kunselman³, Joseph B Clark⁴

Affiliations

¹ Department of Surgery, University of Virginia School of Medicine, Charlottesville, Virginia.
² Department of Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania; Department of Surgery, Penn State College of Medicine, Hershey, Pennsylvania.
³ Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.
⁴ Department of Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania; Department of Surgery, Penn State College of Medicine, Hershey, Pennsylvania. Electronic address: jclark7@hmc.psu.edu.

PMID: 25818568
DOI: 10.1016/j.athoracsur.2014.12.081

Abstract

Background: Bovine pericardial valves are often used for pulmonary valve replacement (PVR) in patients with previously repaired congenital heart disease. Attention has recently focused on the safety of the Mitroflow (Sorin Group USA, Arvada, CO) bovine pericardial valve after a national alert describing several cases of sudden valve failure in young patients. In response, we reviewed our experience using the Mitroflow bioprosthesis for PVR.

Methods: Medical records were reviewed for all patients who underwent PVR using a Mitroflow valve at our center (2008-2013).

Results: The cohort included 84 patients with a median age of 18.3 years (range, 0.8-62.1 years) and weight of 48.4 kg (range, 5.7-167.8 kg). Indications for surgical intervention included native outflow tract insufficiency (59 patients), valved conduit failure (20 patients), and isolated prosthetic valve failure (5 patients). Median length of stay was 3 days (range, 2-13 days). There were no hospital deaths. Median follow-up was 2.4 years (range, 0.2-5.6 years). Pulmonary valve insufficiency and peak gradient increased with time. At latest follow-up, freedom from insufficiency greater than or equal to a moderate degree was 83%, and freedom from a peak gradient greater than or equal to 50 mm Hg was 92%. Reintervention was required in 4 patients. One patient experienced endocarditis and underwent surgical PVR (0.6 years after initial intervention). Three patients underwent transcatheter treatment for valve stenosis including PVR (at 4.2 and 4.4 years in 2 patients) and balloon valvuloplasty (at 5.2 years in the third patient). Kaplan-Meier freedom from reintervention at 5 years was 81%.

Conclusions: Early outcomes using the Mitroflow bovine pericardial valve for PVR in children and adults with repaired congenital heart disease appear acceptable and similar to reported outcomes for other tissue valve options. Valve failure from premature structural deterioration was not observed.

MeSH terms

Adolescent
Adult
Animals
Bioprosthesis*
Cattle
Child
Child, Preschool
Female
Heart Defects, Congenital / complications*
Heart Defects, Congenital / surgery
Heart Valve Diseases / complications
Heart Valve Diseases / surgery*
Heart Valve Prosthesis Implantation*
Heart Valve Prosthesis*
Humans
Infant
Male
Middle Aged
Pericardium
Prosthesis Design
Pulmonary Valve*
Retrospective Studies
Treatment Outcome
Young Adult