Transcatheter Pulmonary Valve Replacement With the Sapien Prosthesis

Shahanavaz, Shabana; Zahn, Evan M.; Levi, Daniel S.; Aboulhousn, Jamil A.; Hascoët, Sébastien; Qureshi, Athar M.; Porras, Diego; Morgan, Gareth J.; Heaton, Holly Bauser; Martin, Mary Hunt; Keeshan, Britton; Asnes, Jeremy D.; Kenny, Damien; Ringewald, Jeremy M.; Zablah, Jenny E.; Ivy, Margaret P.; Morray, Brian H.; Torres, Alejandro; Berman, Darren P.; Gillespie, Matthew J.; Chaszczewski, Kasey J.; Zampi, Jeffrey D.; Walsh, Kevin; Plessis, Julien; Goldstein, Bryan H; Sathanandam, Shyam; Karsenty, Clément; Balzer, David T.; McElhinney, Doff B.

doi:10.1016/j.jacc.2020.10.041

Cited by 68 publications

(50 citation statements)

References 33 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Compared to other series, this series had a similar proportion of patients with tetralogy of Fallot as the underlying congenital defect (1)(2)(3)(4)(5). These studies report 0-4% of patients requiring a reintervention during follow-up, a range that includes our reported 1%.…”

Section: Relation To Prior Studiesmentioning

confidence: 57%

“…Transcatheter pulmonary valve replacement (TPVR) has become an accepted modality of pulmonary valve replacement in suitable candidates. Large studies have demonstrated favorable hemodynamic profile in the midterm with both the Melody (Medtronic Inc., Minneapolis, MN, USA) and Edwards Sapien Transcatheter Heart Valve (Edwards Lifesciences, Irvine, CA, USA) (1)(2)(3)(4)(5). As the population of patients with congenital heart defects continues to age, understanding the role of TPVR in the interventional armamentarium becomes of increasing importance.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Transcatheter pulmonic valve implantation in adult patients with prior congenital heart surgery

Spigel

Adachi

Binsalamah

et al. 2021

Ann Cardiothorac Surg

Self Cite

View full text Add to dashboard Cite

Background: Transcatheter pulmonary valve replacement (TPVR) is now an established modality for pulmonary valve replacement in suitable candidates. We aim to describe our experience with TPVR in adults.Methods: This is a descriptive study of all TPVR performed in adults with congenital heart disease at a single institution from 2010-2020. All adult patients (defined as 18 years old or older at TPVR) were included. Time-to-event outcomes were described using Kaplan-Meier estimates with 95% confidence intervals (CIs).Results: Out of a total of 200 patients that had undergone TPVR, 81 patients (57% male) met the inclusion criteria, with a median age and weight of 26 years (IQR 21-37) and 71.0 kg (IQR 54.6-89.0), respectively.In the cohort, 45 (56%) patients had tetralogy of Fallot. While 53 (65%) patients received a Melody valve, a Sapien valve (S3 in 20, XT in eight) was implanted in the rest. Pre-stenting was performed in 49 (52%) patients. One patient died of severe heart failure a year following TPVR. One patient had a second TPVR performed 2.2 years following initial TPVR for severe pulmonary regurgitation. Valve survival at 2.2 years was 94% (95% CI: 87-100%). Four patients developed endocarditis. Endocarditis-free survival was 89% (95% CI: 80-100%) at three years.Conclusions: Our experience suggests favorable results of TPVR in adults with congenital heart disease.Additional research would be warranted with a focus on total valve longevity and patient reported outcomes, in order to improve the understanding of TPVR in this population and further refine this technology.

show abstract

Section: Relation To Prior Studiesmentioning

confidence: 57%

Section: Introductionmentioning

confidence: 99%

Transcatheter pulmonic valve implantation in adult patients with prior congenital heart surgery

Spigel

Adachi

Binsalamah

et al. 2021

Ann Cardiothorac Surg

Self Cite

View full text Add to dashboard Cite

show abstract

“…Inclusion was limited to those patients receiving an Edwards SAPIEN XT valve, a device that has been recently replaced by the S3 bioprosthesis, which presents improved features such as a better delivery system, an outer sealing skirt, a greater height, and a specific stent‐frame cell design. Currently mostly S3 valves are implanted 28,30 . Therefore, our results may not reflect strictly the most recent clinical practices.…”

Section: Discussionmentioning

confidence: 80%

Edwards SAPIEN XT transcatheter pulmonary valve implantation: 5‐year follow‐up in a French Registry

Ruz

Plessis

Houeijeh

et al. 2021

Cathet Cardio Intervent

View full text Add to dashboard Cite

Objectives This study sought to investigate patient intermediate‐term outcomes after transcatheter pulmonary valve replacement (TPVR) with Edwards SAPIEN valve. Background The Edwards SAPIEN valve, initially designed for percutaneous aortic valve replacement, has been approved for TPVR in patients with dysfunctional right ventricular outflow tracts (RVOT), but only short‐term follow‐up has been reported. Methods From 2011 to 2016, 62 patients undergoing successful TPVR using the SAPIEN XT valve were consecutively included into the study. Primary efficacy and safety endpoints were defined as freedom from valve‐reintervention and freedom from infective endocarditis at last follow‐up, respectively. Results The primary efficacy outcome was met for 87.1% patients after a mean follow‐up of 4.6 ± 1.8 years, corresponding to a freedom of reintervention at 5 years of 89% (95% CI 74.8–95.6%). Reinterventions were exclusively due to recurrent obstruction, no significant valvular regurgitation was observed. One case of infective endocarditis was reported, corresponding to a rate of 0.35% per patient‐year (95% CI 0.01–2.00%). At 5 years, freedom from infective endocarditis was 98.4% (95% CI 89.1–99.8%). Six patients died or were transplanted due to advanced cardiac failure, without relationship with TPVR. In univariate analysis, reintervention was associated with young age, a smaller tube‐graft, a higher pulmonary valve gradient after the procedure and a ratio of largest implanted stent diameter to invasive balloon conduit diameter over 1.35. Conclusions This study documents the mid‐term safety and efficacy of the Edwards SAPIEN XT valve in patients with dysfunctional RVOT, and identifies a patient profile associated with an uncertain benefit–risk balance.

show abstract

“…Renal protection strategies such as pre-hydration, sodium bicarbonate administration or N-acetylcysteine administration could have been employed to justify a contrast angiographic evaluation of this patient’s RVOT [ 16 , 26 ]. The most extensive report to date on patients with Sapien 3 PPVI reports complication rates of 10% accounting for all RVOT substrates [ 27 ]. Our ongoing practice remains such that in the immediate post-PPVI evaluation of patients with RVOT conduits and calcified homografts, we perform RVOT angiography to assess for contained or uncontained tissue rupture.…”

Section: Discussionmentioning

confidence: 99%

“…All other patients had normal pre-and post-procedural renal biochemistry. Median BUN was 17.5 mg/dl (6-23) before the interven-tion and 16.5 mg/dl (11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27) afterwards (normal range: 7-25 mg/dl). Mean serum creatinine of 0.77 mg/dl (0.41-1.43) before the intervention and 0.78 mg/dl (0.49-1.45) after the intervention (normal range: 0.70-1.30 mg/dl).…”

Section: Baseline Characteristicsmentioning

confidence: 99%

Contrast-free percutaneous pulmonary valve replacement: a safe approach for valve-in-valve procedures

O’Callaghan¹,

Zablah²,

Leahy³

et al. 2021

pwki

View full text Add to dashboard Cite

Introduction: Percutaneous pulmonary valve replacement (PPVI) continues to gather pace in pediatric and adult congenital practice. This is fueled by an expanding repertoire of devices, techniques and equipment to suit the heterogenous anatomical landscape of patients with lesions of the right ventricular outflow tract (RVOT). Contrast-induced nephropathy is a real risk for teenagers and adults with congenital heart disease (CHD).Aim: To present a series of patients who underwent PPVI without formal RVOT angiography and propose case selection criteria for patients who may safely benefit from this approach.Material and methods: We retrospectively collected PPVI data from the preceding 2 years at our institution identifying patients who had been listed as suitable for consideration for contrast-free PPVI from our multidisciplinary team (MDT) meeting based on predefined criteria. Demographic, clinical, imaging and hemodynamic data were collected. Data were analyzed using SPSS.Results: Twenty-one patients were identified. All patients had a technically successful implantation with improvements seen in invasive and echocardiographic hemodynamic measurements. 90% of patients had a bio-prosthetic valve (BPV) in situ prior to PPVI. One patient had a complication which may have been recognized earlier with post-intervention RVOT contrast injection.Conclusions: Zero-contrast PPVI is technically feasible and the suitability criteria for those who might benefit are potentially straightforward. The advent of fusion and 3D imaging in cardiac catheterization laboratories is likely to expand our capacity to perform more procedures with less contrast. Patients with bio-prosthetic valves in the pulmonary position may benefit from contrast-free percutaneous pulmonary valve implantation.

show abstract

Transcatheter Pulmonary Valve Replacement With the Sapien Prosthesis

Cited by 68 publications

References 33 publications

Transcatheter pulmonic valve implantation in adult patients with prior congenital heart surgery

Transcatheter pulmonic valve implantation in adult patients with prior congenital heart surgery

Edwards SAPIEN XT transcatheter pulmonary valve implantation: 5‐year follow‐up in a French Registry

Contrast-free percutaneous pulmonary valve replacement: a safe approach for valve-in-valve procedures

Contact Info

Product

Resources

About