Midterm Experience with the Self-Expandable Venus P-Valve™ for Percutaneous Pulmonary Valve Replacement in Large Right Ventricular Outflow Tracts

Background. Preliminary results with the recently certified self-expandable Venus P-Valve™ designed for percutaneous pulmonary valve implantation in patients with dilated right ventricular outflow tracts are encouraging, but experience is limited. We therefore assessed our early and midterm outcomes...

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Published inJournal of interventional cardiology Vol. 2024; pp. 1 - 9
Main Authors Kramer, Peter, Schleiger, Anastasia, Duong, Phuoc, Berger, Felix
Format Journal Article
LanguageEnglish
Published Wiley 22.05.2024
John Wiley & Sons, Inc
Subjects
Online AccessGet full text
ISSN0896-4327
1540-8183
1540-8183
DOI10.1155/2024/5728998

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Abstract Background. Preliminary results with the recently certified self-expandable Venus P-Valve™ designed for percutaneous pulmonary valve implantation in patients with dilated right ventricular outflow tracts are encouraging, but experience is limited. We therefore assessed our early and midterm outcomes with the Venus P-Valve™. Methods. Twenty patients who underwent Venus P-Valve™ implantation in our institution were included in this retrospective study. Procedural data and clinical, imaging, and hemodynamic data at baseline and last follow-up were recorded and analyzed. Results. Mean patient age was 35.0 ± 16.8 years, and five patients were <18 years of age. Procedural success was 100%, and there was no major valve-related procedural complication. At last follow-up (median 0.5 (range 0.1–6.6) years), valve function was excellent in all patients. Two patients had mild regurgitation after 6.2 and 6.6 years, respectively, while all other patients had no or only trace regurgitation. Flow was unobstructed with a mean gradient estimated by echocardiography of 12 ± 4 mmHg. NYHA functional class improved significantly (p=0.009), and right ventricular dimensions significantly decreased (right ventricular end-diastolic diameter 56±9 mm vs. 44±8 mm) (p<0.001). Transient benign ventricular arrhythmias were frequent. One patient experienced a severe arrhythmia with sustained ventricular tachycardia during follow-up. Conclusions. Early and midterm results with the Venus P-Valve™ are excellent. It considerably extends the interventional options and offers a safe and effective alternative to surgery in patients with large right ventricular outflow tracts. Larger multi-institutional studies with longer follow-up duration are required to reliably assess the long-term performance and possible long-term complications of the Venus P-Valve™.
AbstractList Background. Preliminary results with the recently certified self-expandable Venus P-Valve™ designed for percutaneous pulmonary valve implantation in patients with dilated right ventricular outflow tracts are encouraging, but experience is limited. We therefore assessed our early and midterm outcomes with the Venus P-Valve™. Methods. Twenty patients who underwent Venus P-Valve™ implantation in our institution were included in this retrospective study. Procedural data and clinical, imaging, and hemodynamic data at baseline and last follow-up were recorded and analyzed. Results. Mean patient age was 35.0 ± 16.8 years, and five patients were <18 years of age. Procedural success was 100%, and there was no major valve-related procedural complication. At last follow-up (median 0.5 (range 0.1–6.6) years), valve function was excellent in all patients. Two patients had mild regurgitation after 6.2 and 6.6 years, respectively, while all other patients had no or only trace regurgitation. Flow was unobstructed with a mean gradient estimated by echocardiography of 12 ± 4 mmHg. NYHA functional class improved significantly (p=0.009), and right ventricular dimensions significantly decreased (right ventricular end-diastolic diameter 56±9 mm vs. 44±8 mm) (p<0.001). Transient benign ventricular arrhythmias were frequent. One patient experienced a severe arrhythmia with sustained ventricular tachycardia during follow-up. Conclusions. Early and midterm results with the Venus P-Valve™ are excellent. It considerably extends the interventional options and offers a safe and effective alternative to surgery in patients with large right ventricular outflow tracts. Larger multi-institutional studies with longer follow-up duration are required to reliably assess the long-term performance and possible long-term complications of the Venus P-Valve™.
Background. Preliminary results with the recently certified self-expandable Venus P-Valve™ designed for percutaneous pulmonary valve implantation in patients with dilated right ventricular outflow tracts are encouraging, but experience is limited. We therefore assessed our early and midterm outcomes with the Venus P-Valve™. Methods. Twenty patients who underwent Venus P-Valve™ implantation in our institution were included in this retrospective study. Procedural data and clinical, imaging, and hemodynamic data at baseline and last follow-up were recorded and analyzed. Results. Mean patient age was 35.0±16.8years, and five patients were <18years of age. Procedural success was 100%, and there was no major valve-related procedural complication. At last follow-up (median 0.5 (range 0.1-6.6) years), valve function was excellent in all patients. Two patients had mild regurgitation after 6.2 and 6.6years, respectively, while all other patients had no or only trace regurgitation. Flow was unobstructed with a mean gradient estimated by echocardiography of 12±4mmHg. NYHA functional class improved significantly (p=0.009), and right ventricular dimensions significantly decreased (right ventricular end-diastolic diameter 56±9mm vs. 44±8mm) (p<0.001). Transient benign ventricular arrhythmias were frequent. One patient experienced a severe arrhythmia with sustained ventricular tachycardia during follow-up. Conclusions. Early and midterm results with the Venus P-Valve™ are excellent. It considerably extends the interventional options and offers a safe and effective alternative to surgery in patients with large right ventricular outflow tracts. Larger multi-institutional studies with longer follow-up duration are required to reliably assess the long-term performance and possible long-term complications of the Venus P-Valve™.
Background . Preliminary results with the recently certified self-expandable Venus P-Valve™ designed for percutaneous pulmonary valve implantation in patients with dilated right ventricular outflow tracts are encouraging, but experience is limited. We therefore assessed our early and midterm outcomes with the Venus P-Valve™. Methods . Twenty patients who underwent Venus P-Valve™ implantation in our institution were included in this retrospective study. Procedural data and clinical, imaging, and hemodynamic data at baseline and last follow-up were recorded and analyzed. Results . Mean patient age was 35.0 ± 16.8 years, and five patients were <18 years of age. Procedural success was 100%, and there was no major valve-related procedural complication. At last follow-up (median 0.5 (range 0.1–6.6) years), valve function was excellent in all patients. Two patients had mild regurgitation after 6.2 and 6.6 years, respectively, while all other patients had no or only trace regurgitation. Flow was unobstructed with a mean gradient estimated by echocardiography of 12 ± 4 mmHg. NYHA functional class improved significantly ( p = 0.009 ), and right ventricular dimensions significantly decreased (right ventricular end-diastolic diameter 56±9 mm vs. 44±8 mm) ( p < 0.001 ). Transient benign ventricular arrhythmias were frequent. One patient experienced a severe arrhythmia with sustained ventricular tachycardia during follow-up. Conclusions . Early and midterm results with the Venus P-Valve™ are excellent. It considerably extends the interventional options and offers a safe and effective alternative to surgery in patients with large right ventricular outflow tracts. Larger multi-institutional studies with longer follow-up duration are required to reliably assess the long-term performance and possible long-term complications of the Venus P-Valve™.
Audience Academic
Author Schleiger, Anastasia
Duong, Phuoc
Berger, Felix
Kramer, Peter
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SubjectTerms Cardiac patients
Tachycardia
Valves
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Title Midterm Experience with the Self-Expandable Venus P-Valve™ for Percutaneous Pulmonary Valve Replacement in Large Right Ventricular Outflow Tracts
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