Transcatheter Closure Of Paravalvular Leaks Research Articles

Early Outcomes Following Transcatheter Closure With the Amplatzer Vascular Plug and Duct Occluder for Mitral Paravalvular Leak in Japanese Patients.

Transcatheter closure of paravalvular leak (PVL) has become an established treatment for patients at prohibitive surgical risk. However, few studies have examined the feasibility of transcatheter closure using Amplatzer occluders in Japanese patients with mitral PVL. Twelve patients (mean [±SD] age 78±7 years) with heart failure, hemolytic anemia, or both after surgical mitral prosthetic valve replacement (mechanical valve, 75%) underwent transcatheter PVL closure with Amplatzer Vascular Plug II (AVP-II)/Amplatzer Duct Occluder II (ADO-II) between 2014 and 2021 at Toho University Ohashi Medical Center. We examined procedural, in-hospital, 30-day, and 1-year outcomes. All procedures were performed under general anesthesia using an antegrade transseptal approach, and the procedures were successful in all cases. The mean (±SD) number of Amplatzer occluders deployment per patient was 2.9±1.1, and in 2 patients the combined use of ADO-II was required. The mitral PVL grade decreased notably from 3+ to 1+, with residual PVL being mild or absent in 9 patients. There were no all-cause mortalities, major adverse events, or device-related complications at the 30-day follow-up. At 1 year, all-cause mortality was 16.7% and 3 (25%) patients required reintervention because of the recurrence of clinical symptoms. Our findings suggest that transcatheter PVL closure with AVP-II/ADO-II can be feasible and safe in Japanese patients with mitral PVL, leading to satisfactory early clinical outcomes.

Transcatheter closure management of mitral paravalvular leakage: A single center experience.

Paravalvular leakage (PVL) is a common complication after artificial valve replacement. Transcatheter paravalvular leak closure (PVT), an efficient, safe, and minimally invasive treatment for PVL patients. The purpose of this study was to present our experience with transcatheter closure of mitral paravalvular leakage (PVL) after surgical valve replacement in our center. A cohort of 81 consecutive patients with mitral PVLs was treated with transcatheter closure between September 2014 and December 2022. We reviewed the demographics, clinical features, therapeutic modalities and follow-up results. The patients' charts were used for retrospective analysis. Eighty-one patients from one center were enrolled in this study. The median age of the patients was 63 ± 11 years. The median LVEF was 51% ± 7%, and the median regurgitation volume was 11.5 ± 10.1 mL. Sealing with occlusion was successful in 70 patients, and the technical success rate was 86.5%. The median regurgitation volume was reduced to 1.95 ± 2.6 mL. The major adverse event was hemolysis, which affected 19 patients, 17 of whom required blood transfusion. Three patients required secondary open surgery due to bleeding. Three patients died during the hospital stay, and all of their deaths were caused by hemolysis-related complications. The median hospital stay was 10.3 ± 6.3 days. During the follow-up period, 2 patients died, and none of their deaths were caused by surgery. The New York Heart Association classification increased in all patients during the 6-month follow-up. Transcatheter mitral PVL closure requires complex catheter techniques. However, this technique is minimally invasive and has a shorter hospital stay. Interventional mitral PVL closure is a safe and efficacious technique for high-risk surgical patients with symptomatic paravalvular regurgitation.

Transcatheter Paravalvular Leak Closure With Covered Stent Tract and Vascular Plug: Tootsie Roll Technique

BackgroundTranscatheter closure of transcatheter heart valve (THV)–related paravalvular leak (PVL) is associated with a high failure rate with available devices due to the complex interaction of THV and aortic/mitral annulus. ObjectivesThis study reports on novel transcatheter techniques to treat PVL after THV. MethodsThe authors describe consecutive patients who underwent PVL closure after transcatheter aortic valve replacement (TAVR) or transcatheter mitral valve replacement (TMVR). A covered self-expanding stent (Viabahn) was deployed in the defect to create a seal between the THV and annulus. A vascular plug (Amplatzer Vascular Plug 2 [AVP2] or AVP4) was then deployed inside the covered stent to obliterate PVL. ResultsEight patients with THV-related PVL were treated using this method (aortic [3 SAPIEN, 1 Evolut], mitral [2 SAPIEN-in-MAC (mitral annular calcification), 2 M3 TMVR). Various combinations of stents and plugs were used (5 mm × 2.5 cm Viabahn + 6 mm AVP4 [n = 2], 8 mm × 2.5 cm Viabahn + 10 mm AVP2 [n = 5], and 10 mm × 5.0 cm Viabahn + 12 mm AVP2 [n = 1]). All had technical success with immediate elimination of target PVL, without in-hospital complications. None had signs of postprocedure hemolysis. All patients were discharged alive (median 3.5 days [Q1-Q3: 1.0-4.8 days]). No residual PVL was seen at discharge, except for 1 patient with mild regurgitation due to another untreated PVL location. One patient died before 30 days due to complication of valve-in-MAC TMVR. In remaining patients, none had recurrence of PVL at 30 days. Symptoms decreased to NYHA functional class I/II in 6 patients. NYHA functional class III symptoms remained in 1 patient with mitral regurgitation awaiting subsequent valve replacement procedure. ConclusionsThe technique of sequential deployment of a covered stent and vascular plug may effectively treat THV-related PVL.

Correlation of Clinical Outcomes with the Prominent Indication of Transcatheter Paravalvular Leak Closure: A Multicenter Experience.

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). 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. 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. Transcatheter paravalvular leak closure can be performed with high technical and clinical success rates without any difference according to the prominent indication of closure.

Left main coronary artery embolization after transcatheter paravalvular leak closure

Left main coronary artery embolization after transcatheter paravalvular leak closure

3D printing from transesophageal echocardiography for planning mitral paravalvular leak closure - feasibility study.

Transcatheter closure of paravalvular leak (PVL) is still a demanding procedure due to the complex anatomy of PVL channels and risk of interference between the implanted occluder and surrounding structures. Efforts are made to improve procedural outcomes in transcatheter structural heart interventions by establishing treatment strategy in advance with the use of 3D-printed physical models based on data obtained from cardiac computed tomography (CT) studies. In this feasibility study 3D printing of PVL models based on data recorded during transesophageal echocardiography (TEE) examinations was evaluated. 3D-TEE data of patients with significant PVL around mitral valve prostheses were used to prepare 3D models. QLab software was used to export DICOM images in Cartesian DICOM format of each PVL with the surrounding tissue. Image segmentation was performed in Slicer, a free, open-source software package used for imaging research. Models were printed to actual size with the Polyjet printer with a transparent, rigid material. We measured dimensions of PVLs both in TEE recordings and printed 3D models. The results were correlated with sizes of occluding devices used to close the defects. In 7 out of 8 patients, there was concordance between procedurally implanted occluders and pre-procedurally matched closing devices based on 3D-printed models. 3D-printing from 3D-TEE is technically feasible. Both shape and location of PVLs are preserved during model preparation and printing. It remains to be tested whether 3D printing would improve outcomes of percutaneous PVL closure.

Predictors of clinical success after transcatheter paravalvular leak closure: An international prospective multicenter registry

Predictors of clinical success after transcatheter paravalvular leak closure: An international prospective multicenter registry

Procedural Tools and Technics for Transcatheter Paravalvular Leak Closure: Lessons from a Decade of Experience

Prosthetic paravalvular leaks (PVLs) are associated with congestive heart failure and hemolysis. Surgical PVL closure carries high risks. Transcatheter implantation of occluding devices in PVL is a lower risk but challenging procedure. Of the available devices, only two have been specifically approved in Europe for transcatheter PVL closure (tPVLc): the Occlutech® Paravalvular Leak Device (PLD) and Amplatzer™ ParaValvular Plug 3 (AVP 3). Here, we review the various tools and devices used for tPVLc, based on three observational registries including 748 tPVLc procedures performed in 2005-2021 at 33 centres in 11 countries. In this case, 12 registry investigators with over 20 tPVLc procedures each described their practical tips and tricks regarding imaging, approaches, delivery systems, and devices. They considered three-dimensional echocardiography to be the cornerstone of PVL assessment and procedure guidance. Anterograde trans-septal mitral valve and retrograde aortic approaches were used in most centres, although some investigators preferred the transapical approach. Hydrophilic-coated low-profile sheaths were used most often for device deployment. The AVP 3 and PLD devices were chosen for 89.0% of procedures. Further advances in design and materials are awaited. These complex procedures require considerable expertise, and experience accumulated over a decade has no doubt contributed to improve practices.

Predictors of clinical success after transcatheter para-valvular leak closure: an international prospective multicentre registry

Abstract Background Prosthetic paravalvular leaks (PVLs) are associated with congestive heart failure and haemolysis, for which the standard treatment is open-heart surgery with the attendant risks to the patient. Transcatheter closure has emerged as an alternative. Patient selection criteria for the best option are needed. We aimed to identify predictors of clinical success after transcatheter PVL closure. Purpose We aimed to identify predictors of clinical success after transcatheter PVL closure. Methods Consecutive patients referred to 24 European centres for transcatheter PVL closure in 2017–2019 were included in a prospective registry (Fermeture de Fuite ParaProthétique, FFPP). Clinical success was absence of any of the following within 1 month: re-admission for heart failure, blood transfusion, open-heart valvular surgery, and death. Results We included 216 symptomatic patients, who underwent 238 percutaneous PVL closure procedures on the mitral (64.3%), aortic (34.0%), or tricuspid (1.7%) valve. The prosthesis was mechanical in 53.3% and biological in 45.3% of procedures. All patients were symptomatic with heart failure, haemolytic anaemia, and the association of both conditions in 48.9%, 7.8% and 43.3%. One, two and three PVL were addressed during the same procedure in 69.6%, 26.6% and 3.8% respectively. Mitral and aortic PVL were severe in 35.3% and 13.8% (p<0.001). PVL was punctiform or extended to 1/8 or 1/4 of valve circumference in 18.6%, 52.4% and 28.1% of cases. A total of 331 devices were implanted. More than one device (up to 5) was implanted in 34.2% of procedures. Vascular plug 3, muscular ventricular septal defect occluder, vascular plug 2 and paravalvular leak device were the most frequently used devices, implanted in 45.0%, 16.0%, 14.2% and 13.6%, respectively. Successful device(s) implantation(s) within the leak and leak reduction ≤ grade 2 occurred in 85.0% and 91.4% of patients with mitral and aortic procedures, respectively (p=0.164), with major intra-procedural adverse event rates of 3.3% and 1.2%, respectively (p=0.371). The clinical success rates were 77.8% and 88.9% following mitral and aortic procedures, respectively (p=0.01). By multivariate logistic regression analysis, technical failure, mechanical valve and haemolytic anaemia were independently associated with absence of clinical success (odds ratios [95% CIs]: 7.7 [2.0–25.0], p=0.002; 3.6 [1.1–11.1], p=0.036 and 3.7 [1.2–11.9], p=0.025; respectively). Conclusion Transcatheter PVL closure is efficient and safe in symptomatic patients but is more challenging and associated with an increased risk of clinical failure when performed in patients with hemolysis and/or on a mechanical valve. Funding Acknowledgement Type of funding sources: Private hospital(s). Main funding source(s): The study is promoted and financially supported by Groupe Hospitalier Paris Saint Joseph

TCT-499 Multicenter Experience of Transcatheter Paravalvular Leak Closure: Technical Success and Clinical Follow-up Based on the Indication of PVL Closure and Type of Valve Treated

TCT-499 Multicenter Experience of Transcatheter Paravalvular Leak Closure: Technical Success and Clinical Follow-up Based on the Indication of PVL Closure and Type of Valve Treated

3D-Printing to Plan Complex Transcatheter Paravalvular Leaks Closure.

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.

Paravalvular Regurgitation: an Overview of Indications for Closure and Management Strategies.

Paravalvular leak (PVL) after surgical or transcatheter valve replacement is common, occurring in up to one-third of patients. As a method to avoid open surgery, transcatheter closure of PVL has become an established therapy in selected cases. To facilitate procedural success, baseline comprehensive assessment by echocardiography and cardiac computed tomography (CCT), intraprocedural guidance by echocardiography and fluorography, and appropriate wire rail techniques are essential. We present examples of how to treat challenging PVL cases in the aortic and mitral positions. Although challenging, transcatheter PVL repair is effective and safe for treatment of PVL in selected cases by experienced operators.

Mitral Paravalvular Leak: Clinical Implications, Diagnosis and Management.

Paravalvular leak incidence after mitral surgical replacement ranges from 7% to 17%. Between 1% and 5% of these are clinically significant. Large PVLs can cause important clinical manifestations such as heart failure or haemolysis. Current guidelines consider that surgical reparation is the gold-standard therapy in symptomatic patients with paravalvular leak. However, these recommendations are based in non-randomized observational registries. On the other hand, transcatheter paravalvular leak closure has shown excellent results with a low rate of complications, and nowadays it is considered the first option in selected patients in some experienced centres. In this review, we summarize the clinical manifestations, diagnosis, procedural details, and results of transcatheter mitral PVL closure.

Transcatheter paravalvular leak closure is an effective alternative to surgical repair with respect to 5-year outcomes

Abstract Introduction Paravalvular leakage (PVL) is a relatively common complication of heart valve replacement, associated with heart failure and increased mortality. Transcatheter PVL closure may be a promising alternative to surgical repair, especially in high-risk patients. Purpose Assessment of safety and efficacy of transcatheter PVL closure compared to surgical repair. Methods This is a retrospective single-centre study including all consecutive patients who underwent either transcatheter PVL closure between January 2013 and December 2020, or surgical repair between March 2015 and December 2020. Primary endpoints were 5-year all-cause mortality and the composite of 5-year cardiovascular mortality and rehospitalization for the underlying condition. Secondary endpoints were technical success and individual patient success at one year according to the PVL Academic Research Consortium. Results Of the 129 patients included, 85 went for transcatheter repair and 44 went for surgical repair. As compared to surgical repair, patients undergoing transcatheter PVL closure were older (71 years vs. 64,5 years; p≤0,01) and more symptomatic (NYHA class III & IV; 76,5% vs. 59,1%; p=0,04). At 5 years, transcatheter PVL closure was comparable to surgery in terms of the primary composite endpoint (HR: 1,20; 95% CI: 0,68–2,13; p=0,54), all-cause mortality (HR: 1,70; 95% CI: 0,82–3,50; p=0,15) and rehospitalization for the underlying condition (HR: 1,12; 95% CI: 0,54–2,89; p=0,780). Rates of technical success (92,9% vs. 95,5%; p=0,58) and individual patient success at one year (70,6% vs. 77,3%; p=0,87) were similar between transcatheter PVL closure and surgery respectively. Transcatheter PVL closure was associated with shorter in-hospital stay (7 days vs. 14 days; p≤0,01). Conclusion These findings support the use of transcatheter closure of PVL, especially in high-risk patients. Long term survival remains temperate in these challenging patients. Funding Acknowledgement Type of funding sources: None.

Transcatheter paravalvular leak closure: catch me if you can.

Transcatheter paravalvular leak closure: catch me if you can.

Percutaneous paravalvular leak closure with their outcomes: A single center experience.

Background:Transcatheter paravalvular leak (PVL) closure in recent times has emerged as a safe and effective alternate to redo-surgical repair. We sought to examine the clinical efficacy and safety of percutaneous PVL closure at our center.Methods and Results:A retrospective study from August 2012 to December 2019 of 19 patients who underwent 21 procedures for PVL closure. The mean age was 49.25 ± 14.72 years. The target valve was mitral in 11 (57%) and aortic in 7 (36%) cases. One (5%) patient had prosthetic valve in left atrioventricular valve with congenitally corrected transposition of great arteries. Majority of the cohort presented with heart failure without hemolysis (89%), with most of them being in NYHA functional class III (57%) or class IV (21%). A procedural success of 85% was achieved. Post procedure severity of regurgitation reduced from severe in thirteen patients and moderate in six patients to moderate in two patients and mild in fourteen patients. Symptomatic improvement was observed in all cases who had successful closure with NYHA function class improving from 3 ± 0.64 to 1.6 ± 0.94. The mean follow-up duration was 21 ± 13 months (median 24 months). There was one (4.7%) mortality with cumulative survival from all-cause mortality of 95%.Conclusion:The results of percutaneous PVL closure appear encouraging in our series with modest number of patients and offers a promising alternative to redo-surgery in this high-risk cohort.

Long-term echocardiographic findings after TAVR: 5-year follow-up in 400 consecutive patients

A little is known about long-term hemodynamic performance of the transcatheter heart valves (THVs). The aim of the present study was to assess hemodynamic outcome, structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) in patients treated with transcatheter aortic valve replacement (TAVR) five or more years ago. All consecutive patients treated at Bologna and Florence University Hospitals with TAVR between January 2008 and December 2013 were analyzed in a retrospective registry with regards to demographic, procedural and outcome data as well as follow-up data on mortality and echocardiographic characteristics. Standardized definitions were used to define outcomes and durability of the THVs. 400 patients were included in the study, mostly treated with transfemoral TAVR (71.8%), using first generation balloon-expandable (37%) or self-expanding (63%) devices. The 1-year mortality was 21.8% (87 patients) and 5-year mortality was 53.8% (215 patients). Median follow-up was 45.5months (14.0-68.9) totaling 1516.7 patient/years, with the longest follow-up being 10.25years. At least one follow-up echocardiogram was available for 320 patients (80%), SVD occurred in 19 of these patients (5.94%): moderate in 17 patients (5.31%) and severe in two patients (0.63%). The hemodynamic presentation was stenosis in most of the cases (12 patients). Late BVF was registered in 10 patients (3.13%) and this was mainly driven by transcatheter paravalvular leak closure (six patients) with subsequent good long-term outcome. Our results confirm that TAVR appears to be a long-lasting treatment strategy with low rates of structural valve degeneration and valve failure.

Transcatheter Closure of Mitral Paravalvular Leak via Multiple Approaches.

Objectives The purpose of this study was to review the experiences with transcatheter closure of mitral PVL after surgical valve replacement. Background Transcatheter closure of paravalvular leak (PVL) is an intricate alternative to surgical closure. But it represents one of the most intricate procedures in the field of structural heart interventions, especially for patients with mitral PVL. Methods From January 2015 through January 2019, 35 patients with mitral PVL after valve replacement underwent transcatheter closure. We reviewed the catheter techniques, perioperative characteristics, and prognosis. The median follow-up was 26 (3–48) months. Results Acute procedural success was achieved in 33/35 (94.3%) patients. Twenty-five patients had single mitral prosthetic valve replacements; 10 had combined aortic and mitral prosthetic valve replacements previously; 28 had mechanical valves; and 7 had bioprosthetic valves. All percutaneous procedures were performed with local anesthesia except for seven transapical cases with general anesthesia. Multiple approaches were used: transfemoral, transapical, and transseptal via an arteriovenous loop. Multiple devices were deployed. There were no hospital deaths. The procedural time was 67–300 (124 ± 62) minutes. Fluoroscopic time was 17–50 (23.6 ± 12.1) minutes. The hospital stay was 5–17 (8.3 ± 3.2) days. Complications included recurrent hemolysis, residual regurgitation, acute renal insufficiency, and anemia. Twenty-seven (77.1%) patients improved by ≥1 New York Heart Association functional class at the 1-year follow-up. Conclusions Transcatheter mitral PVL closure requires complex catheter techniques. However, this minimally invasive treatment could provide reliable outcomes and shorter hospital stays in selected patients. This trial is registered with NCT02917980.

Transbrachial Access for Transcatheter Closure of Paravalvular Leak Following Prosthetic Valve Replacement.

Background: Transcatheter closure of paravalvular leak (PVL) has evolved into an alternative to surgery in high-risk patients. In this study, we introduce a new access for transcatheter closure of PVL and seek to evaluate the feasibility and safety of this access.Methods: We retrospectively analyzed patients undergoing transbrachial access for transcatheter mitral or aortic PVL closure (August 2017–November 2019) at our hospital. All patients underwent puncture of the brachial artery under local anesthesia.Results: The study population included 11 patients, with an average age of 55.91 ± 14.82 years. Ten out of 11 patients were successfully implanted with devices via the brachial artery approach, and one patient was converted to the transseptal approach. The technical success rate of transbrachial access was 90.9%. Mean NYHA functional class improved from 3.1 ± 0.5 before the procedure to 1.9 ± 0.5 after PVL closure. Severe paravalvular regurgitation (PVR) in five patients and moderate PVR in six patients prior to the procedure were significantly reduced to mild in four patients and none in seven patients after the procedure. Complications included one case of pseudoaneurysm and one case of moderate hemolysis aggravation after closure. One patient had an unknown cause of sudden death within 24 h after the procedure. The half-year mortality rate during follow-up was 9.1% (1/11).Conclusions: Transbrachial access for transcatheter closure of PVL may be a feasible and safe treatment and should include well-selected patients. It has several potential advantages of simplifying the procedure process and reducing postprocedural bed rest time.

Transcatheter closure of paravalvular leak: Multicenter experience and follow-up

BackgroundParavalvular leak (PVL) is a common complication following valve replacement, which leads to heart failure and hemolysis. Transcatheter PVL closure has emerged as a reliable alternative with promising results. We quote the combined three-center experience of PVL patients treated percutaneously. MethodsConsecutive patients treated percutaneously for PVL were retrospectively studied. Procedural characteristics, inhospital, and long-term clinical outcomes were assessed. Technical (successful deployment) and clinical (NYHA and/or hemolysis improvement) success were evaluated. ResultsIn total, 39 patients treated for PVL in either the aortic (12 patients) or the mitral (27 patients) position were studied. Amplatzer Vascular Plug III was the most commonly used device among the 45 devices totally implanted. Postprocedurally, the rates of at least moderate PVL (87.5% preprocedurally vs 10.5% at discharge) and functional status (mean NYHA class 2.8 ± 0.7 on admission vs 1.5 ± 0.8 at follow-up) were statistically significantly improved.Total population technical success rate was 89.7%, being comparable between patients treated for mitral or aortic valve PVLs (92.6% vs 83.3%, respectively). Clinical success was achieved in 82.1% of patient cohort without statistical difference among those with isolated aortic or mitral PVL or among those with PVL closure an indication of heart failure or hemolysis. During a mean follow-up of 33.5 months, five patients died, including one periprocedural death. ConclusionsThis multicenter recorded experience confirms that percutaneous PVL closure can be performed with high technical and clinical success rates and limited complications that lead to significant PVL reduction and functional status improvement.