Latest Advances in Paravalvular Leak

A special issue of Journal of Clinical Medicine (ISSN 2077-0383). This special issue belongs to the section "Cardiology".

Deadline for manuscript submissions: closed (20 March 2023) | Viewed by 5834

Special Issue Editors


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Guest Editor
Cardiology Department, IRCCS University, Galeazzi Sant’Ambrogio Hospital, Via Cristina Belgioioso, 173, 20157 Milan, Italy
Interests: interventional cardiology; congenital and structural heart diseases
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Guest Editor
Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
Interests: interventional cardiology; structural heart diseases

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Guest Editor
Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
Interests: interventional cardiology; structural heart diseases

Special Issue Information

Dear Colleagues,

Paravalvular leak (PVL) is a common complication associated with surgical valve replacement and more recently transcatheter valve implantation procedures. Approximately 1% to 5% of patients undergoing mitral or aortic valve replacement experience PVL of various severities, ranging from asymptomatic to life-threatening such as hemolysis, heart failure, and increased risk of endocarditis. Similarly, significant paravalvular aortic regurgitation after transcatheter aortic valve implantation (TAVI) is associated with poor short- and long-term prognosis and underlines the importance of the assessment and treatment of post-TAVI PVL.

Early recognition and intervention are imperative for appropriate management, as medical therapy is not effective. Available imaging techniques such as different echocardiographic modalities, multidimensional computed tomography, and cardiac nuclear resonance in defining the complex anatomy, position, size of the leakage and its quantification are essential for pre-procedural planning. Defect location and shape can present challenges to crossing the leak. Pre-procedure planning for access route is useful to improve procedure success and further optimize outcomes. In particular, intraprocedural fusion of real-time three-dimensional transesophageal echocardiography and cardiac fluoroscopy imaging on the same display have undoubtedly improved the navigation, safety, and efficacy of this technically challenging procedure.

A repeated surgical procedure is generally related to high perioperative risk. For the high-risk symptomatic PVL patient, catheter-based closure conversely has significantly less morbidity and represents a viable therapeutic alternative, with a high success and low complication rate.

The results of systematic review and meta-analysis suggest that successful trans-catheter PVL reduction is associated with a decrease in cardiac mortality and functional class improvement in patients unsuitable for surgical correction.

A surprising number of different devices, vascular plugs, and more recently newly dedicated devices have been used to close aortic or mitral paravalvular leaks. Nevertheless, transcatheter interventions have followed a difficult path of development. The difficulties have been mostly linked to technical issues, such as visualization of the defect and suboptimal delivery systems.

The Special Issue will summarize the most relevant data on the clinical, diagnostic, and technical aspects of PVL treatment and will point out to its limitations and future development.

We hope that this Special Issue “Latest Advances in Paravalvular Leak” will contribute to an increase in the understanding of the problem and will foster international collaboration on the development in this area.

Prof. Dr. Eustaquio Maria Onorato
Prof. Dr. Grzegorz Smolka
Prof. Dr. Wojtek Wojakowski
Guest Editors

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Keywords

  • Percutaneous interventions
  • Paravalvular leak
  • Echocardiography
  • Fusion imaging modalities
  • Intraprocedural guidance
  • Paravalvular leak closure technique

Published Papers (3 papers)

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Research

12 pages, 1798 KiB  
Article
Correlation of Clinical Outcomes with the Prominent Indication of Transcatheter Paravalvular Leak Closure: A Multicenter Experience
by Thekla Lytra, Konstantinos Kalogeras, Theodoros Pesiridis, Carmen Moldovan, Michael Andrew Vavuranakis, Georgia Vogiatzi, Evaggelos Oikonomou, Petros Dardas, Michail Chrissoheris, Vlasis Ninios and Manolis Vavuranakis
J. Clin. Med. 2023, 12(12), 4047; https://doi.org/10.3390/jcm12124047 - 14 Jun 2023
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Abstract
Background: A paravalvular leak (PVL) is a complication following valve replacement, which may lead to heart failure and hemolysis. The aim of this study is to investigate whether the clinical outcome after transcatheter PVL closure differs according to the prominent indication of the [...] Read more.
Background: A paravalvular leak (PVL) is a complication following valve replacement, which may lead to heart failure and hemolysis. The aim of this study is to investigate whether the clinical outcome after transcatheter PVL closure differs according to the prominent indication of the procedure (symptoms of heart failure or hemolysis). Methods: The data of consecutive patients who had transcatheter treatment for PVL between July 2011 and September 2022 in five Greek centers were analyzed. The primary endpoint was the technical, and clinical success rates with regards to the prominent indication of paravalvular leak closure. The secondary endpoints included the evaluation and comparison of the clinical and technical success in relation to the type of valve that was treated (aortic or mitral) as well as the survival analysis in relation to the closure indication and type of valve that was treated. Results: In total, 60 patients were retrospectively studied (39% men, mean age 69.5 ± 11 years). Regarding the primary outcomes, the technical success in patients mainly suffering from hemolysis was 86.1%, while in those presenting heart failure it was 95.8%, p = 0.387. Furthermore, the clinical success was 72.2% and 87.5% among hemolysis and heart failure patients, respectively, p = 0.210. During the follow-up period, the two-year survival rates were significantly better for patients treated for the aortic valve (78.94%) compared to those in the mitral position (48.78%), p = 0.014. In total, 25 patients died (41.7%) during 24 months of follow-up. Conclusions: Transcatheter paravalvular leak closure can be performed with high technical and clinical success rates without any difference according to the prominent indication of closure. Full article
(This article belongs to the Special Issue Latest Advances in Paravalvular Leak)
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14 pages, 17964 KiB  
Article
3D-Printing to Plan Complex Transcatheter Paravalvular Leaks Closure
by Vlad Ciobotaru, Victor-Xavier Tadros, Marcos Batistella, Eric Maupas, Romain Gallet, Benoit Decante, Emmanuel Lebret, Benoit Gerardin and Sebastien Hascoet
J. Clin. Med. 2022, 11(16), 4758; https://doi.org/10.3390/jcm11164758 - 15 Aug 2022
Cited by 5 | Viewed by 1546
Abstract
Background: Percutaneous closure of paravalvular leak (PVL) has emerged as an alternative to surgical management in selected cases. Achieving complete PVL occlusion, while respecting prosthesis function remains challenging. A multimodal imaging analysis of PVL morphology before and during the procedure is mandatory to [...] Read more.
Background: Percutaneous closure of paravalvular leak (PVL) has emerged as an alternative to surgical management in selected cases. Achieving complete PVL occlusion, while respecting prosthesis function remains challenging. A multimodal imaging analysis of PVL morphology before and during the procedure is mandatory to select an appropriate device. We aim to explore the additional value of 3D printing in predicting device related adverse events including mechanical valve leaflet blockade, risk of device embolization and residual shunting. Methods: From the FFPP registries (NCT05089136 and NCT05117359), we included 11 transcatheter PVL closure procedures from three centers for which 3D printed models were produced. Cardiac CT was used for segmentation for 3D printed models (3D-heartmodeling, Caissargues, France). Technology used a laser to fuse very fine powders (TPU Thermoplastic polyurethane) into a final part-laser sintering technology (SLS) with an adapted elasticity. A simulation on 3D printed model was performed using a set of occluders. Results: PVLs were located around aortic prostheses in six cases, mitral prostheses in four cases and tricuspid ring in one case. The device chosen during the simulation on the 3D printed model matched the one implanted in eight cases. In the three other cases, a similar device type was chosen during the procedures but with a different size. A risk of prosthesis leaflet blockade was identified on 3D printed models in four cases. During the procedure, the occluder was removed before release in one case. In another case the device was successfully repositioned and released. In two patients, leaflet impingement was observed post-operatively and surgical device removal had to be performed. Conclusion: In a case-series of complex transcatheter PVL closure procedures, hands-on simulation testing on 3D printed models proved its usefulness to plan and facilitate these challenging procedures. Full article
(This article belongs to the Special Issue Latest Advances in Paravalvular Leak)
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16 pages, 2648 KiB  
Article
Safety, Efficacy and Long-Term Outcomes of Patients Treated with the Occlutech Paravalvular Leak Device for Significant Paravalvular Regurgitation
by Eustaquio Maria Onorato, Francesco Alamanni, Manuela Muratori, Grzegorz Smolka, Wojtek Wojakowski, Piotr Pysz, Aleksejus Zorinas, Diana Zakarkaite, Hélène Eltchaninoff, Pierre-Yves Litzer, François Godart, Patrick Calvert, Christos Christou, Abdurashid Mussayev, Bindo Missiroli, Igor Buzaev, Salvatore Curello, Tullio Tesorio and Antonio Luca Bartorelli
J. Clin. Med. 2022, 11(7), 1978; https://doi.org/10.3390/jcm11071978 - 01 Apr 2022
Cited by 5 | Viewed by 2298
Abstract
Between December 2014 and March 2021, 144 patients with aortic (Ao) or mitral (Mi) paravalvular leaks (PVLs) were enrolled at 21 sites in 10 countries. Safety data were available for 137 patients, who were included in the safety analysis fraction (SAF), 93 patients [...] Read more.
Between December 2014 and March 2021, 144 patients with aortic (Ao) or mitral (Mi) paravalvular leaks (PVLs) were enrolled at 21 sites in 10 countries. Safety data were available for 137 patients, who were included in the safety analysis fraction (SAF), 93 patients with Mi PVLs and 44 patients with Ao PVLs. The full analysis set (FAS) comprised 112 patients with available stratum (aortic/mitral leak) as well as baseline (BL), 180-day or later assessments (2 years). Procedural success (implantation of the device with a proper closure of the PVL, defined as reduction in paravalvular regurgitation of ≥one grade as assessed by echocardiography post implantation) was achieved in 91.3% of FAS patients with Mi PVLs and in 90.0% of those with Ao PVLs. The proportion of patients suffering from significant or severe heart failure (HF), classified as New York Heart Association (NYHA) class III/IV, decreased from 80% at baseline to 14.1% at 2-year follow-up (FAS). The proportion of FAS patients needing hemolysis-related blood transfusion decreased from 35.5% to 3.8% and from 8.1% to 0% in Mi patients and Ao patients, respectively. In total, 35 serious adverse events (SAEs) were reported in 27 patients (19.7%) of the SAF population. The SAEs considered possibly or probably related to the device included device embolization (three patients), residual leak (two patients) and vascular complication (one patient). During follow-up, 12/137 (8.8%) patients died, but none of the deaths was considered to be device-related. Patients implanted with the Occlutech Paravalvular Leak Device (PLD) showed long-lasting improvements in clinical parameters, including NYHA class and a reduced dependency on hemolysis-related blood transfusions. Full article
(This article belongs to the Special Issue Latest Advances in Paravalvular Leak)
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