Summary
Background
Transcatheter valve-in-valve (VIV) implantation in failing bioprosthesis is an emerging field in cardiology.
Aim
To report on a French multicentre experience and a literature review of tricuspid VIV implantation.
Methods
We approached different institutions and collected 10 unpublished cases; a literature review identified 71 patients, including our 10 cases. Clinical aspects and haemodynamic data are discussed.
Results
Among our 10 unpublished cases, the reason for implantation was significant tricuspid stenosis ( n = 4), significant tricuspid regurgitation ( n = 1) or mixed lesion ( n = 5). Implantation was performed under general anaesthesia at mean age 28 ± 17 years. The 22 mm Melody valve was implanted in seven patients; the Edwards SAPIEN valve was implanted in three patients. The procedure succeeded in all cases, despite two embolizations in the right cardiac chambers; in both cases, the valve was stabilized close to the tricuspid annulus using a self-expandable stent, before implantation of a second Edwards SAPIEN valve. Functional class improved in all but one case. Mean diastolic gradient decreased from 9 ± 2.45 mmHg to 3.65 ± 0.7 mmHg ( p = 0.007); no more than trivial regurgitation was noticed. Among the published cases, the Melody valve was implanted in 41 patients, the Edwards SAPIEN valve in 29 patients and the Braile valve in one patient. Short-term results were similar for our 10 cases, but mid-term results are not yet available.
Conclusions
Tricuspid VIV implantation using the Melody or Edwards SAPIEN valves is a feasible and effective procedure for selected patients with failing bioprosthesis.
Résumé
Contexte
Le remplacement valvulaire percutanée avec la technique « valve-in-valve » (VIV) dans une bioprothèse défaillante est une technique innovante en cardiologie.
Objectif
Le but de cette étude est de rapporter une expérience française dans le remplacement tricuspide VIV et une revue de la littérature.
Méthodes
Nous avons approché différents centres et collecté 10 cas non publiés. Une revue de la littérature a pu identifier 71 patients incluant nos 10 patients.
Resultats
Cas non publiés : les raisons du remplacement étaient une sténose tricuspide significative ( n = 4), une fuite tricuspide significative ( n = 1) et une lésion mixte ( n = 5). La mise en place a été effectuée à un âge moyen de 28 ± 17 ans. Une valve Melody de 22 mm a été implantée chez 7 patients, une valve SAPIEN d’Edwards chez 3 patients. L’implantation a réussi chez tous les patients malgré 2 embolisations dans les cavités droites : la valve a été stabilisée contre l’anneau tricuspide avec un stent auto-expansif avant l’implantation d’une seconde valve SAPIEN d’Edwards. Chez tous les patients sauf un, la classe fonctionnelle s’est améliorée. Le gradient tricuspide est passé de 9 ± 2,45 mmHg à 3,65 ± 0,7 mmHg ( p = 0,007), et les patients n’avaient plus de fuite tricuspide ou une minuscule. La revue de la littérature : une valve Melody a été implantée chez 41 patients, une valve Edwards SAPIEN chez 29 patients, et une valve Braile chez un patient. Les résultats immédiats sont comparables à ceux de cette série mais les résultats à moyen terme ne sont pas encore disponibles. Les aspects cliniques et hémodynamiques sont discutés.
Conclusion
Le remplacement tricuspide par une technique VIV utilisant la valve Melody ou la valve SAPIEN d’Edwards est réalisable et efficace chez des patients sélectionnés avec une bioprothèse défaillante.
Background
Tricuspid valve disease is not rare, and can be observed in Ebstein’s anomaly and after ventricular septal defect closure or Fallot repair, rheumatic valve disease or endocarditis; it can also be caused by annulus dilatation secondary to pulmonary hypertension. Patients with this disease often require tricuspid valve replacement with a bioprosthesis, and need reinterventions over time because of valve degeneration . However, reoperative valve replacement carries a higher risk of mortality and morbidity for these patients, who are usually in poor clinical condition compared with when they had the initial valve replacement . The procedure may be also very challenging in terms of the technical aspects of the correction itself, with a risk of extensive damage to the myocardium and the atrioventricular junction. Transcatheter VIV implantation has recently emerged as a therapeutic approach for failing bioprosthetic valves. The presence of prosthetic material provides a support for the valved stent. There are a few publications on the use of both the Edwards SAPIEN™ valve (Edwards Lifesciences, Irvine, CA, USA) and the Melody ® valve (Medtronic Inc., Minneapolis, MN, USA), but most are case reports. This study describes a French multicentre experience (unpublished) and a literature review of tricuspid VIV implantation; technical aspects are discussed.
Methods
A data sheet was circulated to different centres involved in percutaneous pulmonary valve implantation and known to have performed transcatheter tricuspid VIV implantation. For each patient, the following data were collected: age; weight; sex; initial diagnosis; number of previous surgical interventions; number of previous tricuspid valve procedures; preprocedure clinical condition; indication for tricuspid valve repair; characteristics of the implanted tricuspid prosthesis; pre- and postechocardiographic data; complications; and follow-up. We report here on 10 cases from four centres. Most of the investigators belong to the ‘Groupe de cathétérisme interventionnel pédiatrique et congénitale, filiale de cardiologie pédiatrique et congénitale de la Société française de cardiologie’.
In addition, we searched the online medical database ‘PubMed’ for all publications on ‘tricuspid VIV implantation’ using both the Melody and the Edwards SAPIEN valves. We reviewed patient data, procedural details, valve performance and outcome.
Continuous data are presented as means ± standard deviations (range). Paired t tests and Wilcoxon tests were used to compare pre- and post-procedure gradients within patients.
Results
French multicentre experience of tricuspid VIV implantation
Patient population
Table 1 outlines the baseline characteristics of the 10 study patients; most of the patients had congenital heart disease. Mean age at implantation was 28 ± 17 years (range 9–60 years); five patients were aged ≤ 18 years at implantation. The mean time period between tricuspid bioprosthesis implantation and dysfunction requiring VIV implantation was 12 ± 9.7 years (range 3–32 years). The size of the dysfunctional valve ranged from 23 to 33 mm (mean 29.5 ± 3.6 mm). All patients presented signs of right heart failure. Five patients were in New York Heart Association (NYHA) functional class III, three were in class II and two were in class IV. In addition, two patients presented with protein-losing enteropathy. After a multidisciplinary discussion, the patients were referred for percutaneous VIV implantation.
| Patient | Age (years) | Sex | Weight (kg) | Pathology | Valve size (mm) | Valve type |
|---|---|---|---|---|---|---|
| 1 | 16 | M | 45 | Ebstein’s anomaly | 27 | Mosaic |
| 2 | 15 | M | 59 | Ebstein’s anomaly | 33 | CE |
| 3 | 60 | F | 61 | Ebstein’s anomaly | ||
| 4 | 14 | F | 54 | Ventricular septal defect closure | 23 | Mitroflow |
| 5 | 26 | F | 68 | Tricuspid dysplasia | 31 | CE |
| 6 | 9 | M | 22 | Arterial duct, pulmonary artery hypertension | 27 | CE |
| 7 | 33 | F | 59 | Cardiomyopathy | 33 | CE |
| 8 | 44 | M | 85 | Tricuspid atresia, Fontan type | ||
| 9 | 49 | M | 57 | Rheumatic | 33 | CE |
| 10 | 17 | M | 55 | Ebstein’s anomaly | 29 | CE |
At baseline, the tricuspid maximal gradient was 16 ± 2.5 mmHg and the mean gradient was 9 ± 2.4 mmHg. Reason for VIV implantation was a predominant tricuspid stenosis (defined as mean gradient > 5 mmHg) ( n = 4), a significant tricuspid regurgitation (moderate-to-severe tricuspid regurgitation) ( n = 1) or a mixed lesion combining significant tricuspid stenosis and regurgitation ( n = 5).
Procedures
Informed consent was obtained from all patients. The procedure was done under general anaesthesia. Owing to potential complications requiring emergency surgery, surgical backup was available for most of the implantations. Balloon sizing, using a low-pressure balloon catheter to delineate the dimension of the annulus, was employed in nine patients; predilatation using a high-pressure balloon was performed in five patients. Before implantation, prestenting was done in six patients, including one who had four stents implanted to reduce the annulus size before implantation of a 22-mm Melody valve. All patients underwent successful VIV implantation: the Melody valve was used in seven patients; the Edwards SAPIEN valve was used in three patients.
No periprocedural death, myocardial infarction, stroke or stent fracture occurred. Two embolizations of the Edwards SAPIEN valve within the right ventricle and the right atrium were observed. In both cases, the valve was stabilized close to the tricuspid annulus by overlapping stents, using a self-expandable Sinus-XL stent (OptiMed, Ettlingen, Germany) and then a balloon-expandable stent, before successful implantation of a second Edwards SAPIEN valve ( Fig. 1 ). Ventricular ectopics were noticed in two patients; these resolved in a few days.
Haemodynamic outcomes
The mean gradient decreased from 9 ± 2.45 mmHg to 3.65 ± 0.7 mmHg ( p = 0.007). The degree of valve regurgitation improved in all patients ( Table 2 ).
| Patient | Type of lesion | Valved stent | Mean gradient (mmHg) | Regurgitation | Balloon sizing | Prestenting | Pacing | Complications | ||
|---|---|---|---|---|---|---|---|---|---|---|
| Pre | Post | Pre | Post | |||||||
| 1 | TS + TR | Edwards 23 | 10 | 4 | Moderate | Trivial | Yes | No | Yes | Migration |
| 2 | TS + TR | Edwards 26 | 6 | 4 | Severe | Trivial | Yes | One Max™ LD stent a | Yes | |
| 3 | TS + TR | Melody 22 | 8 | 5 | Severe | None | Yes | Two covered CP™ stents b ; one Max LD stent + one CP stent | Yes | |
| 4 | TS | Melody 22 | 9 | 4 | Mild | None | Yes | No | No | |
| 5 | TS | Edwards 29 | 10 | 4 | No | One Max LD stent; one CP stent | No | Migration; ectopics | ||
| 6 | TS | Melody 22 | 14 | 3 | Mild | Trivial | Yes | No | No | |
| 7 | TR | Melody 22 | 2.9 | Severe | Trivial | Yes | One covered CP stent; one Mega™ LD stent a | No | ||
| 8 | TS | Melody 22 | 10 | 3.6 | Mild | None | Yes | One Max LD stent; one covered CP stent | No | Ectopics |
| 9 | TS + TR | Melody 22 | 8 | 3 | Severe | None | Yes | One covered CP stent; one Mega LD stent | No | |
| 10 | TS + TR | Melody 22 | 6 | 3 | Severe | Trivial | Yes | No | No | |
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