Summary
Background
Percutaneous implantation of pulmonary valves has recently been introduced into clinical practice.
Aim
To analyse data of patients treated in France between April 2008 and December 2010.
Methods
Prospective, observational, multi-centric survey by means of a database registry of the Filiale de cardiologie pédiatrique et congénitale.
Results
Sixty-four patients were included, with a median (range) age of 21.4 (10.5–77.3) years. The majority (60.9%) of the patients were New York Heart Association (NYHA) class II. The most common congenital heart disease was tetralogy of Fallot with or without pulmonary atresia (50%). Indication for valve implantation was stenosis in 21.9%, regurgitation in 10.9% and association of stenosis and regurgitation in 67.2%. Implantation was successful in all patients. Pre-stenting was performed in 96.9% of cases. Median (range) procedure time was 92.5 (25–250) minutes. No significant regurgitation was recorded after the procedure, and the trans-pulmonary gradient was significantly reduced. Early minor complications occurred in five cases (7.8%). Three patients died during a median follow-up of 4.6 (0.2–5.2) years, two from infectious endocarditis and one from end-stage cardiac failure. Surgical reintervention was required in three patients. Follow-up with magnetic resonance imaging demonstrated significant improvements in right ventricular volumes and pulmonary regurgitation in mixed and regurgitant lesions.
Conclusions
Transcatheter pulmonary valve implantation is highly feasible and mid-term follow-up demonstrates sustained improvement of right ventricular function. Late endocarditis is of concern, therefore longer follow-up in more patients is urgently needed to better assess long-term outcome.
Clinical trial registration
Résumé
Contexte
La valvulation pulmonaire percutanée a récemment été introduite en pratique clinique.
Buts
Analyser les données des patients traités en France entre avril 2008 et décembre 2010.
Méthodes
Étude prospective, observationnelle, multicentrique sous la forme d’un registre sous l’égide de la filiale de cardiologie pédiatrique et congénitale de la Société française de cardiologie.
Résultats
Soixante-quatre patients ont été inclus à un âge médian de 21,4 (10,5–77,3) ans. La majorité (60,9 %) était en classe New York Heart Association (NYHA) II. La cardiopathie congénitale la plus fréquente était la tétralogie de Fallot avec ou sans atrésie pulmonaire (50 %). L’indication de valvulation était une sténose pure chez 21,9 %, une régurgitation chez (10,9 %) et l’association d’une sténose et d’une régurgitation chez 67,2 %. La valvulation a été réalisée avec succès chez tous les patients. Un préstenting a été fait chez 96,9 % des cas. La durée moyenne (intervalle) de la procédure était de 92,5 (25–250) minutes. Il n’y avait pas de régurgitation significative après la procédure, et le gradient transpulmonaire a été significativement réduit. Des complications mineures sont survenues dans cinq cas (7,8 %). Trois patients sont décédés durant le suivi median de 4,6 (0,2–5,2) ans, deux d’une endocardite infectieuse et un d’une insuffisance cardiaque terminale. Des réinterventions chirurgicales ont été pratiquées chez trois patients. Le suivi par l’imagerie à résonnance magnétique nucléaire a montré une amélioration significative des volumes ventriculaires droits et de la régurgitation pulmonaire dans les lésions mixtes et régurgitantes.
Conclusions
La valvulation pulmonaire par cathétérisme interventionnel est faisable. Le suivi à moyen terme montre une amélioration significative de la fonction ventriculaire droite. Les endocardites tardives sont une préoccupation importante. Des études avec un suivi plus long et un plus grand nombre de patient sont indispensables afin de mieux évaluer le devenir à long terme.
Background
Right ventricular outflow tract (RVOT) dysfunction after repair of congenital and structural heart disease has been treated, during the past four decades, by surgical placement of a conduit between the right ventricle and the pulmonary artery . Due to patient growth and conduit degeneration, these conduits have to be replaced frequently over the course of a lifetime . Transcatheter approaches for the management of dysfunctional RVOT have evolved over time, from high-pressure balloon dilation and stent implantation to transcatheter pulmonary valve implantation (TPVI) . Since the introduction of TPVI, the majority of studies have reported its feasibility with excellent results .
Our study reports on a national multicentre registry supported by the Filiale de cardiologie pédiatrique et congénitale (FCPC) and funded by the Ministery oh Health (Soutien aux Techniques Innovantes et Coûteuses, 2008).
Methods
Selection criteria and study design
From May 2008 to December 2010, a prospective, observational, multicentre registry was used to assess indications, results and complications of TPVI with the Melody ® valve (Medtronic Inc., Minneapolis, MN, USA) in patients with dysfunctional RVOT conduits. A grant was offered by the French Ministry of Health under the protocol “Soutien aux Techniques Innovantes et Coûteuses 2008” to study TPVI with the Melody ® valve in 64 patients.
Patients with obstruction, pulmonary regurgitation or mixed lesions were included. RVOT procedures included balloon dilatation with or without bare metal stent insertion and TPVI. Patients were enrolled in five tertiary academic centres in France (Necker Hospital for Sick Children, Paris; George-Pompidou European Hospital, Paris; Institut Hospitalier Jacques-Cartier, Massy; Unit for children and adults with congenital heart defects, Bordeaux and La Timone Hospital, Marseille). Patients were included according to each implanting centres’ indications and practice, based on the usual criteria used for surgical or TPVI:
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symptomatic patients with Doppler mean gradient > 35 mmHg and/or at least moderate pulmonary regurgitation;
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asymptomatic patients with the following criteria by: magnetic resonance imaging (MRI) (right ventricular end-diastolic volume index > 150 mL/m 2 or Z-score > 4; right ventricular end-systolic volume index > 80 mL/m 2 ; right ventricular ejection fraction < 47%; left ventricular ejection fraction < 55%; large RVOT aneurysm) and/or electrocardiography (sustained tachyarrhythmia related to right heart volume load with QRS duration > 140 ms) and/or echocardiography (mean Doppler gradient > 40 mmHg) and/or haemodynamics (RVOT obstruction with RV systolic pressure ≥ 2/3 systemic pressure).
Procedural and follow-up data were entered in to a database approved by an institutional review board. Demographic data, procedural details and immediate and mid-term outcomes and complications were obtained for all patients. Patients with native RVOT, native pulmonary valve stenosis and age < 5 years and/or weight < 25 kg were excluded. Patients with active endocarditis, infection or sepsis, pregnancy or central vein occlusion were also excluded. During pre-implantation catheterization, patients in whom a coronary compression was diagnosed were also excluded. The survey was approved by the national ethics committee. Written informed consent was obtained from each patient and/or his/her parents or legal guardian. The study is registered at the National Institute of Health website ( http://www.clinicaltrials.gov ) with identifier NCT01250327 .
Pre-procedure evaluation
All patients underwent a pre-procedure clinical evaluation including electrocardiogram (ECG), echocardiography (assessment of biventricular function, pulmonary regurgitation and right ventricular pressure), chest X-ray, exercise testing, MRI (assessment of ventricular volumes by manually tracing the epicardial and endocardial borders and evaluation of ejection fraction and pulmonary regurgitation fraction).
Diagnostic catheterization
Cardiac catheterization was performed under sedation or general anaesthesia. RVOT stenosis was deemed as the primary indication if the RVOT peak-to-peak gradient and RV pressure were > 25 mmHg and > 2/3 systemic pressure, respectively. Pulmonary regurgitation was deemed to be the primary indication in the presence of angiographically significant pulmonary regurgitation with an RVOT peak systolic pressure ≤ 25 mmHg. Patients who did not meet the specific criteria for RVOT stenosis or regurgitation were classified as mixed lesions.
Procedure
The Medtronic Melody ® Transcatheter Pulmonary Valve (Model PB10) was implanted, according to the technique previously described . Risk for coronary compression was assessed with aortic root angiogram in two views (lateral and four-chamber views) and/or selective coronary angiogram, prior to and during high-pressure balloon inflation. Importantly, we ensured that the size of the balloon used to assess coronary compression always matched the expected diameter of the bare metal stent or Melody ® valve. Most of the patients had pre-stenting of the RVOT with CP (NuMed Inc., Hopkinton, NY, USA) and/or ev3 LD Max (ev3 Endovascular Inc., Plymouth, MN, USA) .
Data reporting
Data collected for each patient included their congenital cardiac lesions, the substrate of RVOT (conduit, bioprosthesis or pericardial patch reconstruction of outflow tract), the number and type of previous surgeries and their New York Heart Association (NYHA) class. The following primary outcomes were collected: procedural success (no or trivial regurgitation on post-implantation angiogram and a post-implantation peak-to-peak gradient ≤ 20 mmHg), complications, TPVI-related death and mid-term follow-up success.
Patients were evaluated (clinical assessment, ECG, chest X-ray and echocardiography) 24 hours after implantation, at 1, 3, 6 and 12 months and every year. Echocardiographic data were collected: any significant (> trivial) pulmonary regurgitation, systolic right ventricular pressure (if tricuspid regurgitation), ventricular diameters and function. MRI was performed within 6 months after TPVI. Cine-angiogram looking for stent fractures was performed at any time during follow-up in case of increased RVOT gradient during follow-up, signs of pulmonary embolism, appearance of or increase in pulmonary regurgitation, with or without stent fractures on standard X-ray. Stent fractures with no clinical repercussion or haemodynamic consequences were disregarded. The follow-up information was collected from the patient’s chart. Any death or reintervention occurring during follow-up was fully investigated.
Statistical analysis
PASW statistics 17.0 (SPSS Inc., SPSS, Chicago, USA) was used for statistical analysis. Data are expressed as mean (standard deviation [SD] or range) if normally distributed or as median (range). Nominal variables are expressed as numbers and percentages. Student’s paired t test was used to evaluate the difference after TPVI. Categorical variables were compared using the χ 2 test, the Wilcoxon signed-rank test and the Mann–Whitney U test. Kaplan–Meier actuarial survival curves were obtained. All tests were two-sided and a P value of < 0.05 was considered statistically significant.
Results
Patient characteristics
Characteristics of the 64 included patients are reported in Table 1 . The majority (60.9%) of the patients were NYHA class II, while no patient was class IV. Indications for valve implantation was pure stenosis in 14 patients (21.9%), pure regurgitation in seven (10.9%) and association of stenosis and regurgitation in 43 (67.2%).
| All patients ( n = 64) | |
|---|---|
| Age at TPVI (years) | 21.4 (10.5–77.3) |
| Women | 38 (59.4) |
| NYHA class | |
| I | 16 (25.0) |
| II | 39 (60.9) |
| III | 9 (14.1) |
| Congenital heart disease | |
| TOF–PA-VSD | 32 (50.0) |
| Common arterial trunk | 9 (14.1) |
| LVOT disease post Ross surgery | 8 (12.5) |
| DORV and variants | 6 (9.4) |
| Transposition of the great arteries | 5 (7.8) |
| Pulmonary stenosis | 3 (4.7) |
| cc-TGA | 1 (1.6) |
| Previous surgeries | |
| 1 | 10 (15.6) |
| 2 | 24 (37.5) |
| 3 | 18 (28.1) |
| 4 | 9 (14.1) |
| 5 | 3 (4.7) |
| Primary indication(s) number (%) | |
| Pulmonary stenosis and regurgitation | 43 (67.2) |
| Pulmonary stenosis | 14 (21.9) |
| Pulmonary regurgitation | 7 (10.9) |
| Pre-stenting | 62 (96.9) |
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