Percutaneous Paravalvular Leak Closure Research Articles

Transcatheter mitral paravalvular closure: a single centre experience with techniques and outcomes

Background In patients with symptomatic mitral PVL, successful transcatheter reduction of the PVL to less than mild is associated with significant improvement in short- and midterm survival. Objectives In this study, we present our single-centre, same operators’ experience on percutaneous paravalvular leak closure with techniques and outcomes. Methods In this retrospective observational designed study, we retrieved hospital records of patients with a surgical history of mechanical or biological prosthetic valve replacement and who subsequently underwent transcatheter mitral paravalvular leak closure (TMPLC). All procedures were performed by the same operators. Results A total of 45 patients with 58 PVDs underwent TMPLC using 60 devices. All patients had moderate or severe mitral paravalvular regurgitation associated with symptomatic HF (15.6%), clinically significant haemolytic anaemia (57.8%) or both (26.7%). The technical success rate was 91.4%, with 53 defects successfully occluded. The clinical success rate was 75.6%. Among the clinical success parameters, the preprocedural median ejection fraction increased from 45% (35–55) to 50% (40–55) (p = .04). Mitral gradients decreased from max/mean 18/8 mmHg to max/mean 16/7 mmHg; p = .02). Haemoglobin levels increased from 9.9 (8.5–11.1) to 11.1 (3–13); p = .003. LDH levels decreased from 875 (556–1125) to 435 (314–579); p: <.001. All-cause 30-day and in-hospital mortality rates were the same at 8.9%. Conclusion This single-centre study with a limited number of patients confirmed that TMPLC is a safe and effective procedure to improve symptoms and severity of PVL.

Percutaneous paravalvular leak closure after transcatheter aortic valve implantation: the international PLUGinTAVI Registry.

Data regarding the safety and long-term effectiveness of percutaneous closure of paravalvular leak (PVL) after transcatheter aortic valve implantation (TAVI) are scarce. This study aims to present alarge multicentre international experience of percutaneous post-TAVI PVL closure. All patients who underwent percutaneous post-TAVI PVL closure in 14 hospitals across Europe and North America between January 2018 and October 2022 were included. Overall, 45 patients (64% male) were enrolled. The median age was 80 years (75-84). Among them, 67% and 33% had self-expanding and balloon-expandable valve implantations, respectively. Baseline post-TAVI PVL was severe in 67% of cases and moderate in the rest. The time from index TAVI to PVL closure procedure was 16.1 (8.7-34.8) months. Most patients were in NYHA Class III and IV (73%) before the procedure, and 40% had referred hospitalisations for heart failure between TAVI and the PVL closure procedure. Successful PVL closure was achieved in 94%, reducing regurgitation to ≤mild in 91% and moderate in the rest. The Amplatzer Valvular Plug III was the most frequently used device (27 cases), followed by the Amplatzer Valvular Plug 4. The incidence of severe adverse events was 11%. None of the patients died during the index hospitalisation. During long-term follow-up (21.7±16.2 months), the all-cause mortality rate was 14%, and patients presented improvement in functional status and asignificant reduction in the rate of hospitalisation for heart failure (from 40% to 6%). Percutaneous PVL closure is afeasible and safe option for treating post-TAVI leaks. Successful PVL reduction to mild or less could be associated with acute and long-lasting improvements in clinical outcomes.

Simultaneous percutaneous closure of aortic paravalvular leak and residual shunt of ventricular septal defect.

Simultaneous percutaneous closure of aortic paravalvular leak and residual shunt of ventricular septal defect.

Percutaneous Closure of Paravalvular Leak After Tricuspid Valve Replacement for Ebstein's Anomaly

Percutaneous Closure of Paravalvular Leak After Tricuspid Valve Replacement for Ebstein's Anomaly

Mitral Paravalvular Leak 3D Printing from 3D-Transesophageal Echocardiography.

Paravalvular leaks can be detected in almost 15% of patients after mitral valve prosthesis implantation. This complication can result in congestive heart failure and hemolysis. Despite advancements in non-invasive imaging, percutaneous closure of paravalvular leaks is not always successful. Therefore, efforts are made to improve treatment outcomes by using 3D-printed models of defects as pre-procedural support for interventional cardiologists. Retrospectively, 3D-transesophageal echocardiography recordings of 8 patients with clinically significant mitral paravalvular leaks were analyzed. Qlab Software was used to export DICOM images of each paravalvular leak channel, including surrounding tissue. Image segmentation was performed in 3D Slicer, a free, open-source software package used for imaging research. Models were printed to actual size with the poly jet Stratasys Objet 30 printer with a transparent, rigid material. Duration of model preparation and printing, as well as the total cost, was calculated. Mean total time of model preparation was 430.5 ± 196 minutes. 3D-printing from 3D-transesophageal echocardiography is technically feasible. Both shape and location of paravalvular leaks are preserved during model preparation and printing. It remains to be tested if 3D-printing would improve outcomes of percutaneous paravalvular leaks 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.

Percutaneous Closure of Mitral Paravalvular Leak: Long-Term Results in a Single-Center Experience.

Background: Paravalvular leak occurs in 5–17% of patients following surgical valve replacement, more often in mitral position. The prognosis without treatment is poor. Percutaneous device closure represents an alternative to repeat surgery. The objective of this work is to evaluate the medium and long-term results in the percutaneous closure of PVL in mitral prosthesis. Methods: This observational study is based on a retrospective registry including consecutive mitral PVL cases undergoing percutaneous closure at a single tertiary-care center from April 2010 to December 2020. The safety and efficacy results of the procedure, at 90 days and in the long term, were analyzed. Also, predictors of procedure failure and long-term events were identified. Results: A total of 128 consecutive mitral paravalvular leak closure procedures were included. Technical success was achieved in 115 (89.8%) procedures. The presence of multiple PVLs was the sole factor that independently predicted procedural failure. Median follow-up of our sample was 41.8 months (mean 47.7 ± 35.7 months). Underlying hemolytic anemia as the indication for PVL closure, a recent admission for decompensated HF, and lack of improvement in functional class emerged as consistent predictors of MACE and death during long-term follow-up, while lack of procedural success during the first PVL procedure and chronic kidney disease were also associated with MACE during follow-up. Conclusions: Percutaneous mitral PVL closure displayed high technical and procedural success rates, with an acceptable safety profile, in a high-risk population. Percutaneous mitral PVL closure achieved an improvement in short- and long-term functional class and a reduction of hemolysis in the vast majority of patients. In addition, long-term survival in our study was good, in particular for patients undergoing successful PVL closure procedures.

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.

Transesophageal Echocardiography (TEE)-Guided Paravalvular Leak (PVL) Closure: Expanding Horizons Beyond Operating Room

AbstractParavalvular leak (PVL) is a common, yet challenging entity occurring due to dehiscence of the annular tissue around the prosthetic valve, resulting in regurgitation of blood retrogradely. Although any prosthetic valve can be subjected to the risk of developing PVL, it is most commonly reported with the mitral valve followed by the aortic valve. The incidence of mitral PVL is around 7 to 17%, whereas with the aortic valve it is 5 to 10%. Symptomology can vary from asymptomatic patients with mild PVL to disabling symptoms pertaining to heart failure and hemolysis. TEE plays a pivotal role in the overall assessment along with procedural guidance for their closure. Multiple two-dimensional (2D) imaging views are required to scan the entire sewing ring diameter of a prosthetic valve. Three-dimensional (3D) TEE can give crucial information such as the number, size, shape, and circumference of the defects. 3D mitral en face view can give anatomical localization of the defect. During the procedure, TEE can assist in the confirmation of the position of the guidewire through the defect and not through the prosthetic valve. It also helps to conform to the adequate positioning of the vascular plug device and unrestrictive movement of the native prosthetic heart valve. TEE when combined with fluoroscopy can help in real-time guidance of passage of the guidewire and transcatheter device in relation to the prosthetic valve. Recently, Ahmed et al have named this technology as “Fusion Technique,” where they have combined real-time 2D and 3D TEE with fluoroscopy to facilitate the closure of PVL. Now that the time of minimally invasive surgery has taken over conventional surgery and fast tracking and enhanced recovery after surgery (ERAS) is the need of the moment, percutaneous PVL closure is preferred over surgical PVL closure. A study done by Gakrinho et al showed that percutaneous PVL closure has a reasonable success rate along with a low complication rate and the results are comparable to surgical treatment in high-risk patients. We hereby share our experience of the successful closure of PVL via the transcatheter technique using various 2D and 3D techniques.

Percutaneous paravalvular leak closure: a single-centre experience of 54 cases

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Clinically significant paravalvular leak (PVL) occurs in 5-10% of patients undergoing surgical aortic and 5-17% patients undergoing surgical mitral valve replacement and even more often after trancutaneous aortic valve implantation (TAVI). Surgical repair of a PVL is associated with a 30-day mortality of approximately 10%. Percutaneous closure of PVL (pPVLC) has emerged as an alternative to surgical repair. Aim We retrospectively analysed the success rate and clinical outcomes of patients with significant PVL, who were turned down from re-do cardiac surgery, and treated with pPVLC at our tertiary referral centre. Methods Patients who were admitted for pPVLC between 27th of September, 2009 and 21st of April, 2021 were enrolled into the study. 30-day and 1-year mortality rates were assessed. Technically successful pPVLC was defined as stable device position, and minimum 1 grade reduction in PVL severity. Results pPVLC was performed in 54 cases (32 males, 22 females, mean age: 69.5 ± 10.9 yrs). The main indication for closure was heart failure (81%) and haemolysis (19%). The median time since valve surgery was 4.5 yrs (IQR: 0.9-15.2 yrs). Regarding the leaks, 70% (n = 38) were in mitral position (mechanical vale: 33 cases, bioprosthesis: 5 cases) and 30% (n = 16) in aortic position (mechanical valve: 12 cases, bioprosthesis: 2 cases, TAVI: 2 cases). A total of 53 leaks were identified in mitral position (one leak: 25 cases, two leaks: 11 cases, three leaks: 2 cases), and 25 leaks in aortic position (9 cases, 5 cases and two cases resp.). In mitral position 1 device was used in 73% of cases, 2 devices in 21%, and 3 devices in 6%. In aortic position: 62%, 19%, and 19 % resp. Techinal succes was achieved in 49 case (91%). The 30-day mortality was 8%, the 1-year mortality 21%. Conclusions Patients with significant PVL represent an extreme or even prohibitive surgical risk cohort. In these high risk individuals percutaneous PVL offers a safe alternative to surgical PVL repair and appears particularly effective in patients presenting with heart failure or haemolysis.

Echocardiographic guidance in transcatheter structural cardiac interventions.

Catheter-based treatment of structural heart diseases (SHD) has seen tremendous advances in the past decades, thanks to the development of new devices and advances in imaging techniques. Today, we have an extensive armamentarium of imaging tools for preprocedural planning, intraprocedural guidance and follow-up of SHD. Intraprocedural guidance is based mainly on transoesophageal echocardiography; however, other imaging modalities are used as complementary or alternative techniques, each of them with its strengths and weaknesses. Thus, a multimodality imaging approach provides added values in this setting. As the field of imaging parallels the continuous technical improvements, this review will describe the state of the art imaging techniques, focusing on echocardiography during procedural guidance of the most common catheter-based interventions, providing tips and tricks for interventional cardiologists: in particular, how to guide transseptal crossing; left atrial appendage closure; transcatheter mitral or tricuspid valve repair or replacement; percutaneous closure of patent foramen ovale and atrial defects; and percutaneous closure of paravalvular leaks. Open challenges for the near future are the need for physicians with specific technical skills and competencies in SHD imaging, more attention to high levels of radiation exposure, and optimisation of intraprocedural and post-procedural evaluation.

Quality of life after percutaneous paravalvular leak closure - a prospective registry.

Presence of paravalvular leaks (PVLs) can lead to heart failure, which decreases quality of life (QoL). Percutaneous closure is becoming the first-line treatment of PVLs, but whether such a procedure could improve QoL in these patients has never been examined. To examine changes in scores of the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and Kansas City Cardiomyopathy Questionnaire (KCCQ) after percutaneous PVL closure. Forty subjects with heart failure symptoms and at least moderate PVL were included in this prospective registry. QoL was assessed at baseline and during a 12-month follow-up after percutaneous PVL closure by MLHFQ and KCCQ questionnaires. Changes in NT-proBNP and lactate dehydrogenase (LDH) levels were also analyzed. Technical success (TS) was achieved in 97.5% of cases and procedural success (PS) in 85% of cases. In the group with PS a significant decrease in MLHFQ score as well as an increase in scores of all KCCQ domains was observed. No statistically significant changes were observed in the group without PS, mainly due to the small sample size. Percutaneous PVL closure is associated with better QoL during a 12-month follow-up provided PS was achieved. Due to the low number of subjects in whom PS was not achieved, it is not possible to determine the influence of a failed procedure in this group of patients.

Use of radial access to create an arterio-arterial loop to facilitate the percutaneous closure of paravalvular aortic leak. Is it feasible?

Use of radial access to create an arterio-arterial loop to facilitate the percutaneous closure of paravalvular aortic leak. Is it feasible?

Update in Paravalvular Leak Closure.

Given the low occurrence of clinically important paravalvular leak (PVL), there are no large registries or trials in this space to investigate management strategies. This review integrates newer evidence, particularly in imaging guidance for these complex procedures, novel techniques and approaches that our group has taken, as well as approaches to more complex PVL plugging reported in case reports. Perhaps the largest area of growth in the management of PVL is the use of advanced imaging in both pre-procedure evaluation and intra-procedural guidance with gated cardiac CT, 3D TEE, and fluoroscopy fusion technologies. Outside the USA, a new device, the Occlutech PLD, has become available with early data indicating high success rates. There remains little randomized data to support the efficacy of percutaneous PVL closure. Gated cardiac CT has become key to the pre-procedure evaluation for transcatheter closure as it allows for increased procedural efficiency and more accurate pre-procedure planning, particularly when combined with 3D printing. Intra-procedural TEE-fluoro fusion allows for more rapid crossing of defects by providing a visual target for interventionalists. The advent of purpose-built devices for PVL closure may further increase the efficacy and efficiency of percutaneous closure, but significant barriers remain for approval of these devices in the USA.

Long-term outcomes of catheter-based intervention for clinically significant paravalvular leak.

In most centres, clinically significant percutaneous paravalvular leak (PVL) closure following valve replacement surgery is reserved for those considered high-risk for surgery. There is a paucity of data regarding the long-term outcomes of these patients. Our goals were to assess the long-term outcomes of patients undergoing percutaneous PVL closure. A total of 100 consecutive transcatheter PVL closure procedures (74 mitral, 26 aortic) were performed in 95 patients between February 2005 and August 2019 at our hospital. Data collected included procedural success rates, indication-specific outcomes and mortality. Mean follow-up was 5.6±6.1 years, mean age 62.6±15.2 years, and 45.4% were female. The device was successfully implanted in 88 procedures (88.0%). Patients who presented with heart failure (n=57) had a significant improvement in NYHA classification (29.2% Class III/IV versus 100.0%, p<0.001). For patients who presented with haemolytic anaemia (n=38), haemoglobin increased (11.94±1.634 vs 9.72±1.49, p<0.001) and LDH levels were reduced (1,354.90±1,225.55 vs 2,039.40±1,347.20, p<0.001) following the procedure. Rates of mortality were 3.8% at 90 days, 15.6% after 1 year, and 27.2% after 5 years. For patients who are deemed intermediate- to high-risk for repeat surgery, transcatheter PVL closure shows reasonable clinical success rates, with a significant improvement in symptoms, and a relatively low rate of periprocedural complications.

Percutaneous Closure of Aortic and Mitral Paravalvular Leaks—Diagnostic and Therapeutic Considerations

Paravalvular leak (PVL) represents a suboptimal procedural outcome resulting in an eccentric regurgitant jet following surgical or transcatheter aortic or mitral valve replacements. In this review, the role of integrated imaging modalities, including transthoracic echocardiography, transesophageal echocardiography, cardiac computed tomography, and cardiac magnetic resonance imaging, for the diagnosis and evaluation of aortic and mitral PVL is comprehensively discussed. Interventional procedures for aortic or mitral PVL using various percutaneous closure devices are reviewed. Clinical outcomes of percutaneous closure of PVL in aortic and mitral valves are summarized. PVL occurs in 6% to 15% of aortic valve and 7% to 17% of mitral valve procedures. Percutaneous device closure of PVL has shown an improved survival benefit. Successful reduction in PVL is associated with improved clinical outcomes. Multimodal imaging and inter-disciplinary discussion are essential for a high success rate of percutaneous closure of PVL. Further research on the pathophysiology of PVL and factors affecting complications are needed. A PVL closure device with various available shapes might be helpful for increasing procedural success rates.

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.

Successful percutaneous closure of aortic paravalvular leak in a patient with repeated episodes of open-heart surgery

Successful percutaneous closure of aortic paravalvular leak in a patient with repeated episodes of open-heart surgery

Photo-Realistic Echocardiography Imaging During Percutaneous Paravalvular Leak Closure.

Percutaneous paravalvular leak (PVL) closure is established as an alternative to surgery in selected cases. Transesophageal echocardiography is crucial to perform detailed imaging during the procedure. Photo-realistic rendering views (TrueVue, Philips Healthcare, Best, the Netherlands) have been

Üç Ayrı Paravalvüler Defektin Transapikal Yol ile Dört Ayrı Cihazla Kapatılması

Paravalvular leaks (PVL) that complicate prosthetic valve replacement may be observed in 2%-12% of the patients after mitral valve replacement and 1%-5% of the patients after aortic valve replacement. The percutaneous closure of PVL is considered as a less invasive alternative to a surgical closure for symptomatic relief in high-risk patients. The objective of this case report is to present a successful transapical closure of three separate mitral paravalvular defects with four devices in a patient with severe hemolysis.