Prosthetic Paravalvular Leak Research Articles

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.

Review of Prosthetic Paravalvular Leaks: Diagnosis and Management.

Paravalvular leak (PVL) is a relatively uncommon complication associated with prosthetic valve implantation. PVL can occasionally lead to serious adverse consequences such as congestive heart failure, infective endocarditis, and hemolytic anemia. Surgical re-operation carries a high mortality risk. Transcatheter closure therapy provides a viable alternative for the treatment of this disorder with reasonable procedural and clinical success. The recent advent of hybrid imaging modalities has increased procedural success. This article summarizes the pathophysiology, clinical characteristics, and treatment modalities surroundings prosthetic paravalvular leak.

Diagnostic accuracy of cardiac computed tomographic angiography and transesophageal echocardiography in evaluation of patients with prosthetic paravalvular leakage.

Computed Tomography (CT) scan has been well addressed to provide diagnostic information for patients with prosthetic heart valve (PHV) dysfunction. However, its role in the assessment of patients with prosthetic paravalvular leakage (PVL) has not been studied thoroughly. So, this study was conducted to assess the feasibility, reproducibility, and accuracy of CT for diagnosis of prosthetic PVL using surgical findings as the reference standard. This was a prospective cohort study that was conducted on 26 consecutive patients with suspected prosthetic PVL who underwent both transesophageal echocardiography (TEE) and 64-slice ECG-gated CT. The gold standard was the intraoperative findings. Surgery was performed on 26 patients. There was an excellent degree of agreement between CT and intraoperative findings for diagnosis, localization of prosthetic PVL. The perimeter of prosthetic PVL measured by CT was strongly correlated with echocardiographic severity of PVL by TEE (Spearman's Correlation Coefficient, r=.83, p=.0014). This study demonstrates that cardiac CT showed comparable diagnostic accuracy to TEE and intraoperative findings for the detection, localization, and assessment of severity of prosthetic PVL. Moreover, CT was shown to be useful in detection of other findings related to prosthetic cardiac valves.

Feasibility, efficacy and safety of transbrachial access for interventional therapy on paravalvular leak post surgical valve replacement

Objective: To investigate the feasibility, efficacy and safety of transbrachial access for interventional therapy on prosthetic paravalvular leak (PVL) post surgical valve replacement. Methods: This is a retrospective study. Patients with PVL after surgical valve replacement who underwent interventional therapy via the brachial artery approach in Structural heart disease center of Fuwai hospital between August 2017 and October 2019, were included. All patients underwent puncture of the brachial artery under local anesthesia, angiography and transcatheter closure procedure were performed. The procedure was performed under transthoracic echocardiography (TTE) guidance. Baseline data, operation data and pre-and post-operative TTE examination results were collected and analyzed. Postoperative complications were recorded and operational adverse events were obtained during follow up in the outpatient department after discharge. The operation success rate was calculated, which was defined as the degree of perivalvular regurgitation decrease by 1 grade and above according to TTE without interfering the valve movement and coronary artery blood flow within 30 days after occluder placement. Results: A total of 10 patients were enrolled in this study, the mean age was (57.5±14.6) years, and 6 patients were males. There were 7 cases with aortic PVL, and 3 cases with mitral PVL. Except for one patient who was converted to the femoral vein-transseptal approach, the other 9 patients were successfully implanted with the devices via the brachial artery approach. The operation time was (103.3±34.0) minutes, and there was no need for rigorous bed rest after the operation. The median hospital stay was 7.5 (3.0, 9.8) days. The operation success rate was 9/10 via the brachial artery approach. The differences in the degree of perivalvular regurgitation, New York Heart Association (NYHA) classification, left ventricular end diastolic diameter and left atrial diameter before and after operation were statistically significant (all P<0.05). One case developed new hemolysis with renal insufficiency on the second day after procedure and discharged after successful dialysis. Another case experienced complication of brachial artery pseudoaneurysm after procedure and discharged after successful treatment with thrombin injection. The mean follow-up time was (14.3±7.9) months. During the follow-up, NYHA classification remained as Ⅰ/Ⅱ in 9 patients, no operational adverse events were observed. Conclusions: Transbrachial access for interventional therapy on PVL post surgical valve replacement is a feasible, effective, and safe procedure. It has the advantages of simplifying the operation process and reducing postoperative bed rest time.

Cardiovascular magnetic resonance and transesophageal echocardiography in patients with prosthetic valve\xa0paravalvular leaks: towards an accurate quantification and stratification

BackgroundObjective assessment of prosthetic paravalvular leak (PVL) is complex and challenging even in transesophageal echocardiography (TEE). Our aim was to assess the value of cardiovascular magnetic resonance (CMR) in quantifying PVL in aortic (AVR) or mitral valve (MVR) replacement.MethodsThirty-one patients (62 ± 15.1 years, 63% males) with a preliminary diagnosis of significant PVL (AVR, n-23; MVR, n = 8) were recruited. The TEE PVL grading was based on the semi-quantitative (SQ) TEE according to the VARC II PVL classification (%PVL: mild < 10%; moderate 10%–30%; severe > 30%). Non-contrast CMR studies were acquired at 1.5 T with a quantitative approach (phase-contrast velocity encoded imaging). The CMR PVL severity was classified according to regurgitant fraction (RF: (1) mild ≤ 20%, (2) moderate 21%–39%, or (3) severe ≥ 40%).ResultsAll patients revealed symptoms of heart failure (71%: New York Heart Association [NYHA] II; 91%: N-terminal pro-B-type natriuretic peptide [NT-proBNP] > 150 pg/ml) and typical cardiovascular disease risk factors. The SQ-TEE results revealed several categories: (1) mild (n = 5; 16%), (2) moderate (n = 21; 67%), and (3) severe (n = 5; 16%) PVL. However, CMR PVL RF reclassified the severity of PVL: (1) mild to moderate (in 80%), (2) moderate to severe (in 47%), and (3) severe to moderate (in 40%). The receiver operating characteristic analysis showed that SQ-TEE and CMR PVL-vol and -RF predicted the upper tertile of NT-proBNP (> 2000 pg/ml) with the best sensitivity for CMR parameters.ConclusionThe SQ-TEE showed moderate agreement with CMR and underestimated a considerable number of AVR or MVR-PVL.

The Role of Three-Dimensional Transesophageal Echocardiography in the Assessment of Mitral Prosthetic Paravalvular Leak

The Role of Three-Dimensional Transesophageal Echocardiography in the Assessment of Mitral Prosthetic Paravalvular Leak

Added value of three-dimensional transesophageal echocardiography in management of mitral paravalvular leaks.

Prosthetic paravalvular leak (PVL) is a well-known serious complication following surgically as well as percutaneously implanted prosthetic valves. It usually happens due to incomplete sealing of the prosthetic ring to the native cardiac tissue whether immediately postoperative or considerably later as a complication of infective endocarditis, etc Surgery has been always the treatment of choice for clinically significant PVLs. However, percutaneous transcatheter closure therapy has become a successful alternative in carefully selected group of patients. Echocardiography is a cornerstone in the initial diagnosis, assessment of the severity and location of the PVL. Furthermore, it plays a crucial role in the assessment of the feasibility for percutaneous closure and during intra-procedural guidance. Transesophageal echocardiography (TEE) has the advantage over transthoracic echocardiography (TTE) of not being affected by the acoustic shadow of the mitral prosthesis that usually hides the regurgitation jets and makes TTE evaluation difficult. Three-dimensional (3D) TEE has been shown to provide better diagnostic accuracy compared to two-dimensional (2D) TEE as regard to evaluation of PVLs especially in patients with more than one PVL. This is due to better delineation of the location, shape, and size of the PVL and equally important during guiding the transcatheter percutaneous closure.

Severe Mitral Annular Calcification and Mitral Valve Surgery: An Algorithmic Approach to Management

The management of mitral valve dysfunction in the setting of substantial mitral annular calcification (MAC) remains controversial and is one of the most challenging problems in mitral valve surgery. The physiopathology of severe MAC is related to a combination of progressive, degenerative and active calcium deposition in the annulus that is often multifactorial, but largely attributable to aging and chronic disease conditions. Given the fact that overall life expectancy in the elderly population are increasing, it is imperative to understand contemporary and future therapeutic options since this MAC is likely going to be a frequent problem faced by the next generation of cardiac surgeons. This review provides a relevant synthesis of existing literature and aims to assess the efficacy of existing therapeutic choices for patients with mitral valve dysfunction and 'big' MAC with a goal of minimizing postoperative complications (e.g. left ventricular outflow tract obstruction, prosthetic paravalvular leak, valve embolization, and stroke) that can be achieved via a multidisciplinary heart team approach.

Percutaneous closure of prosthetic paravalvular leaks – Should it be considered the first therapeutic option?

Percutaneous closure of prosthetic paravalvular leaks – Should it be considered the first therapeutic option?

Percutaneous closure of mitral paravalvular leaks: Focus on imaging and technique

Symptomatic prosthetic paravalvular leakage is a rare clinical condition occurring in up to 5% of patients after valve surgery. Symptoms include haemolytic anaemia, heart failure or both. Leaks tend to be more common in the mitral compared to the aortic position. Three dimensional transoesophageal echocardiography (3D TOE) is essential prior and during percutaneous leak closure. This imaging technique allows to qualify and quantify the leak and to judge feasibility of a percutaneous approach. It also enables the choice of the most appropriated closure device prior to intervention. During the procedure, 3D TOE guides adequate crossing of the leak and device deployment. It also fi nally allows assessment of the acute procedural result. Percutaneous closure should be considered as the fi rst choice therapy if closure is judged feasible based on 3D TOE assessment. This procedure is currently performed in a limited number of patients by relatively few operators and is characterised by a long learning curve. Currently, literature data are scarce and reported acute procedural success is roughly around 70 to 80%. Intervention is mostly performed with vascular plugs or ventricular septum defect closure devices. Recently, dedicated implants have been made available. Their role has been limited to hybrid procedures from a transapical retrograde approach.

Percutaneous Transapical Closure of Cardiac Apex and Mitral Prosthetic Paravalvular Leak is Feasible and Alternative Approach to the Surgery

Percutaneous Transapical Closure of Cardiac Apex and Mitral Prosthetic Paravalvular Leak is Feasible and Alternative Approach to the Surgery

Abstract 12766: Dissection of the Interventricular Septum: Echocardiographic Features

Objective: Dissection of the interventricular septum (IVS) is an extremely rare entity. An institutional data base review identified 13 pts with the diagnosis, confirmed by cardiac surgery. The purpose of the study was to determine the value of transthoracic echocardiography (TTE) in establishing the diagnosis and to summarize the TTE features of IVS dissection. Methods: The 13 pts with IVS dissection, 8 males and 5 females (age range: 36-75 yrs) were taken from 789,114 TTEs performed between 1985 and 2014. The etiology, anatomical location, echocardiographic morphology, and color Doppler findings of the IVS dissection were noted. Results: The incidence of IVS dissection in our center was 0.000016 %. Among 13 patients with IVS dissection, the right sinus of Valsalva (RSOV) was involved in 11 pts. In 5 pts, a single aneurysm of the RSOV dissected into the IVS. In 4 pts, aortic valve (AoV) endocarditis was associated with the IVS dissection, including one pt with a bicuspid AoV infection, 2 pts with absess formation adjacent to an AoV replacement, one pt. with a combination of a bicuspid AoV and RSOV dissecting into the IVS, and one pt with an AoV prosthetic paravalvular leak following absess formation dissecting into the IVS. In one patient, a bicuspid AoV valve combined with RSOV dissected into the IVS. Also, in one pt, mechanical AoV prosthetic replacement was complicated by annular detachment and a severe paravalvular leak. In all 11 pts with RSOV involvement, TTE showed a dissecting cystic-like mass in the IVS from the base to mid-septum or confined to the septal base. The path of the dissection in all these pts was traced to the RSOV. Also, communications between the dissection and the aortic root were seen in these 11 patients. In the other 2 pts, IVS dissection followed septal rupture due to a myocardial infarction. In these pts, communication between the dissection and the right ventricle was seen. Conclusions: The study showed that dissections of the IVS usually commenced in the RSOV, due to either congenital anomalies or infective endocarditis, or following AoV replacement. The other cause of IVS dissection is a myocardial infarction. The TTE characteristic of IVS dissection is a cystic-like mass in the IVS.

Percutaneous transcatheter obliteration of mitral prosthetic paravalvular leaks

Percutaneous transcatheter obliteration of mitral prosthetic paravalvular leaks

The combination of percutaneous transapical and transseptal closure of cardiac apex and prosthetic mitral paravalvular leak with loop technique

Article history: Received 11 October 2015 Accepted 18 October 2015 Available online 19 October 2015 Firstly, we decided to try the percutaneous transapical approach with a needle without left minithoracotomy. Under general anesthesia, we performed coronary angiography in order to not puncture the left anterior descending artery in apical region (Fig. 2). After that, under TEE and fluoroscopic angiographic guidance, transapical cannulation of the left ventricle from the sixth intercostal area and midclavicular region with a needle was performed and a 6 F sheath was inserted to

Intraoperative three-dimensional transesophageal echocardiography for assessing the defect geometries of mitral prosthetic paravalvular leak during transcatheter closure

BackgroundParavalvular leaks (PVLs) are a common complication of prosthetic valve replacement. Use of the transcatheter intervention technique is a suitable alternative in high-risk patients who may not tolerate repeat surgery. Common reasons for failure of this demanding intervention include poor imaging quality and unsuitable anatomy. The purpose of this study was to assess the usefulness and the incremental value of real-time three-dimensional (RT 3D) transesophageal echocardiography (TEE) over two-dimensional (2D) TEE findings in the evaluation of the geometry and track of mitral PVLs during transcatheter closure. MethodsFive patients with six mitral PVLs at high risk for repeat surgery underwent transcatheter leak closure. Intraoperative RT 3DTEE was used to assess the location, shape, number, and size of the defects. Transapical approaches were used in all cases with fluoroscopic and RT 3D TEE guidance of the wire and catheter, device positioning, and assessment of residual leak after the procedure. ResultsIn all of the cases, defects with irregular crescent shapes and distorted tracks were clearly delineated by RT 3D TEE. This was compared to those results obtained through 2D TEE, which was unable to characterize the defects. Three cases showed small leaks, which were completely occluded with a patent ductus arteriosus (PDA) device in two cases, and a muscular ventricular septal defect (mVSD) occluder combined with coil devices in one case. One case involved a large leak and early device embolization of the muscular VSD occluder, which was removed surgically, and demonstrated a crescent–shaped defect. One patient had two releaks 2 months subsequent to the procedure due to two new extended leaks at the tails of the crescent–shaped defect. ConclusionRT 3D TEE can clearly delineate the geometries of defects in their entirety, including shape, size, and location of the defect and track canal. It would also appear that RT 3D TEE is superior to 2D TEE in the process of guiding the wire through the difficult canal anatomy, facilitating the overall procedure. The small mitral PVLs can be completely occluded, but subsequent complications occurred with large defect closures because of embolization or releak. Therefore, transcatheter closure of PVLs seems to be an attractive alternative for these patients, but newer occluder designs that better conform to leak geometry will be required to improve outcomes.

Use of cardiac CT angiography to assist in the diagnosis and treatment of aortic prosthetic paravalvular leak: A practical guide

Percutaneous repair of aortic paravalvular regurgitation can help avoid the need for repeat valve surgery. Although the initial diagnosis of paravalvular regurgitation is usually made with echocardiography, cardiac CT angiography helps to determine the site and morphology of these leaks. The utility of CT is highly dependent on the quality of the data. Herein, we describe a systematic approach to image acquisition and interpretation of cardiac CT angiography in patients with aortic paravalvular regurgitation, which integrates findings from echocardiography. This approach can be used to minimize inaccuracies in the diagnosis and enhance the procedural success for percutaneous repair of aortic paravalvular regurgitation.

Percutaneous intervention is not always problem-solving in prosthetic paravalvular leakage.

Percutaneous intervention is not always problem-solving in prosthetic paravalvular leakage.

Cardiac imaging in prosthetic paravalvular leaks.

Prosthetic paravalvular leaks (PVL) is an uncommon but serious complication after surgical valve replacement. Although surgery has been the traditional treatment of choice in hemodynamically significant PVL, percutaneous transcatheter closure is emerging as a novel and less invasive option for patients with high operative risk. Cardiac imaging, especially two- and three-dimensional transoesophageal echocardiography, plays an essential role in the diagnosis, guidance of intervention and subsequently in the evaluation of the outcomes of the procedure. The aim of this manuscript is to review the role of cardiac imaging techniques in the interventional management of patients with symptomatic PVL.

Open transapical approach to transcatheter paravalvular leakage closure: a preliminary experience.

Significant prosthetic paravalvular leakage (PVL) could have serious clinical consequences and impairs survival. Reoperation is associated with a high mortality rate, and transcatheter closure is a new treatment modality for high-risk patients. The goal of this study was to determine safety and midterm clinical efficacy of transcatheter PVL closure using an open transapical approach. All consecutive patients who underwent transcatheter PVL closure in our center were prospectively enrolled. Pre- and postprocedural quality of life and 6-minute walk test were ascertained. All outcomes were defined according to the Valve Academic Research Consortium-2 consensus document. In total, 37 consecutive patients (mean age 67±12 years, 65% male, logistic European System for Cardiac Operative Risk Evaluation 27±17%, Society of Thoracic Surgeons score 7±4%) with severe symptomatic PVL in mitral (81%) or aortic (19%) position underwent transcatheter PVL closure. Procedure success was 86%. Early safety at 30 days (ie, event-free survival) was 84%. The 1-year survival rate was 66%. New York Heart Association functional class and quality of life significantly improved. Clinical efficacy (ie, survival free of stroke, rehospitalization, New York Heart Association 3/4, and device-related dysfunction) was 49% at 3 months and 31% at 1 year. Moderate to severe residual PVL was associated with all-cause mortality (hazard ratio, 3.9; 95% confidence interval, 1.2-12.1; P=0.03). The open transapical approach to PVL closure in high-risk patients has a high procedural success rate with an acceptable risk of adverse outcomes. This is the first study to prove an increased functional capacity and quality of life after transapical PVL closure. Residual PVL is associated with 1-year mortality.

PW090 The Effect of Hemolysis on Serum Lipid Levels in Patients Suffering from Mitral and/or Aortic Prosthetic Paravalvular Leakage

PW090 The Effect of Hemolysis on Serum Lipid Levels in Patients Suffering from Mitral and/or Aortic Prosthetic Paravalvular Leakage