Implantation of a catheter-based self-expanding pulmonary valve in congenital heart surgery: results of a pilot study☆

Wattenwyl, Robert von; Arnold, Raoul; Siepe, Matthias; Beyersdorf, Friedhelm; Schlensak, Christian

doi:10.1016/j.ejcts.2010.11.041

Cited by 5 publications

(9 citation statements)

References 12 publications

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“…The No-React® Injectible valve was introduced as a modern surgical valve replacement for minimally invasive and even off-pump procedures [1][2][3][4][5][6]. The potential advantages were ease of implantation, favourable tissue constitution and a perfect landing zone for a percutaneous valve-in-valve.…”

Section: Discussionmentioning

confidence: 99%

“…The potential advantages were ease of implantation, favourable tissue constitution and a perfect landing zone for a percutaneous valve-in-valve. We introduced the valve in our clinical practice with these theoretical advantages in mind, and were satisfied with the initial performance [3,5]. However, we decided to wait to see the mid-term results before using the prosthesis on a broader basis.…”

Section: Discussionmentioning

confidence: 99%

“…Prior to implantation, the valve requires surgical manipulation before the correct position can be obtained. The introducing material has also needed improvement [3,5]. In particular, deployment of the self-expandable No-React® stent system is accompanied by a notorious jump during its injection, carrying a relatively high risk for accidental dislodgement.…”

Section: Discussionmentioning

confidence: 99%

“…The pulmonary valve was replaced with the No-React® injectable valve in 7 patients with a median age of 9 (range 1-24) years at our institution between 2006 and 2010. Our implantation strategy and technique have been reported [3,5]. Our outpatient department followed all these 7 patients carefully.…”

Section: Methodsmentioning

confidence: 99%

“…The No-React® Injectable BioPulmonic™ valve (BioIntegral Surgical, Inc., Mississauga, ON, Canada) was introduced almost 10 years ago as a helpful tool for minimally invasive off-pump replacement of the pulmonary valve [1,2]. The acute and initial results were encouraging [1][2][3][4][5], and have been recently updated by another short-term series [6]. We carefully followed our patient cohort to evaluate the mid-to long-term performance of this stented type of No-React® valve.…”

Section: Introductionmentioning

confidence: 99%

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No-React® Injectable BioPulmonic™ Valves Re-evaluated: Discouraging Follow-up Results

Siepe¹,

Höhn²,

Fleck³

et al. 2016

Thorac cardiovasc Surg

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OBJECTIVES: The No-React® Injectable BioPulmonic™ valve (BioIntegral) was introduced for minimally invasive off-pump replacement of the pulmonary valve almost 10 years ago. We present our mid-to long-term follow-up results. METHODS: We conducted a retrospective analysis of all 7 patients treated at our institution at the median age of 9 (range 1-24) years. The children underwent cardiac catheterization when worsening strain on the right heart was suspected after examining their medical history and/or observing significant changes on echocardiography. RESULTS: After a median follow-up period lasting 5.2 (range 0.7-6.7) years, all patients presented the indication for recatheterization, particularly because the maximum instantaneous velocity measured by Doppler had revealed systolic gradients of a median 63 (dP 18-74) mmHg across the right ventricular outflow. Catheterization confirmed severe stenosis in 2, and moderate stenosis together with moderate insufficiency in 4 patients. We observed two principal failure mechanisms: technical problems resulting from poor alignment to the right ventricular outflow tract and structural problems leading to neointimal proliferation even in cases with appropriate prosthesis positioning. At median of 5.7 (0.7-7) years after implantation, 6 of the 7 patients underwent valve rereplacement. Redo surgery was necessary in 3, and percutaneous valve-in-valve implantation in the remaining 3 patients. Histological analysis of two explanted valves confirmed significant neointima proliferation and thickened valve cusps leading to stenosis of the graft. CONCLUSIONS: These mid-term results after implantation of the No-React® Injectable BioPulmonic™ valve are disappointing. Graft failure was mainly due to neointimal formation and valve malposition.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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