Mitral Paravalvular Leak Closure Research Articles

Impact of percutaneous mitral paravalvular leak closure on the natural history of recurrent gastrointestinal bleeding.

Impact of percutaneous mitral paravalvular leak closure on the natural history of recurrent gastrointestinal bleeding.

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.

Impact of a Successful Percutaneous Mitral Paravalvular Leak Closure on Long-term Major Clinical Outcomes

BackgroundPercutaneous mitral paravalvular leak (PVL) closure techniques are an effective and safe alternative to surgical treatment, but data regarding long-term outcomes are scarce. We aim to describe the impact of successful percutaneous mitral PVL closure on long-term outcomes. MethodsAll consecutive patients in whom a first-attempt percutaneous mitral PVL closure was performed in a single tertiary centre between January 2010 and October 2021 were included. Clinical variables, procedural details, and procedural success were collected. Patients were classified based on procedural success, defined as no more than mild residual leak. All-cause mortality was the primary endpoint. Cardiovascular death and heart failure hospitalizations (HFHs) were key secondary endpoints. ResultsNinety patients (median age 72.5 years [66.0-78.4]; median EuroSCORE-II 8.2 [5.3-12.46]) were included. Although reduction of at least 1 degree in PVL severity was achieved in 82 (91.1%), procedural success was achieved in 47 (52.2%). Chronic kidney disease, previous surgery for PVL, and the presence of multiple jets were independently associated with procedural failure. After a median follow-up of 3.2 (1.2-5.2) years, mortality rate was higher in the procedural failure group (27.3 per 100 patients-years) compared with the group with successful closure (8.2 per 100 patient-years). Procedural failure was associated with all-cause death (adjusted hazard ratio [aHR], 2.59; 95% confidence interval [CI], 1.41-4.78), cardiovascular death (aHR, 3.53; 95% CI, 1.67-7.49) and HFH (aHR, 3.27; 95% CI,1.72-6.20). ConclusionsA successful reduction in PVL to mild or absent is associated with improved rates of all-cause death, cardiovascular death, and HFHs.

Complex Mitral Paravalvular Leak Closure: 3D Printing to the Rescue

Complex Mitral Paravalvular Leak Closure: 3D Printing to the Rescue

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.

Transcatheter Mitral Paravalvular Leak Closure Using Arteriovenous Rail Across Aortic Bileaflet Mechanical Prosthesis: Multimodality Imaging Approach.

Transcatheter Mitral Paravalvular Leak Closure Using Arteriovenous Rail Across Aortic Bileaflet Mechanical Prosthesis: Multimodality Imaging Approach.

Closing Mitral Paravalvular Leak: Comparing Catheter-based Transapical Option against Surgical Treatment Option

Purpose: The goal of this study was to compare the closure of catheter-based transapical option against surgical treatment option for mitral paravalvular leak. &#x0D; Methodology: The study employed a retrospective observational study design to compare closure of mitral paravalvular leak using catheter-based transapical option and surgical treatment option. The study had a sample size of 76 patients who were grouped into surgical group or catheter group. The surgical group was allocated 49 patients after re-do surgery while the catheter group was allocated 27 patients after transapical catheter–based treatment.&#x0D; Findings: According to the study’s result, in-hospital myocardial necrosis occurred in 9 (18%) cases in the surgical group and none in the catheter group, p = 0.018. Procedure-related life-threatening bleeding occurred in 9 (18%) patients in the surgical group and none in the catheter group, p = 0.018. Nine (18%) patients died in 30 days in the surgical group, and none died in the catheter group, p = 0.039. A mean follow-up was 3.3 years. No difference was found between the groups by the degree of residual paravalvular regurgitation either at discharge or at follow-up. During the follow-up, 19 (39%) patients died in the surgical group and 2 (7%) among the catheter patients.&#x0D; Conclusion: Transapical catheter-based closure of mitral paravalvular leak seems to be a safer treatment procedure than conventional re-do surgery, and the effectiveness of these procedures does not differ.

A Comparison of the Catheter-Based Transapical and Surgical Treatment Modalities for Mitral Paravalvular Leak.

Background: There is a lack of studies where the outcomes of mitral paravalvular leak treatment were compared between surgery and catheter-based closure. The aim of this study was to compare the outcomes of re-do surgery with transapical catheter-based paravalvular leak closure. Methods: This is a retrospective observational study at a single institution; 76 patients were included. According to the treatment, two groups were formed: the “Surgical” group (49 patients after re-do surgery) and the “Catheter” group (27 patients after transapical catheter–based treatment). Results: In-hospital myocardial infarction occurred in 9 (18%) cases in the “Surgical” group and none in the “Catheter” group, p = 0.018. Procedure-related life-threatening bleeding occurred in 9 (18%) patients in the “Surgical” group and none in the “Catheter” group, p = 0.018. Nine (18%) patients died in 30 days in the “Surgical” group, and none died in the “Catheter” group, p = 0.039. A mean follow-up was 3.3 years. No difference was found between the groups by the degree of residual paravalvular regurgitation either at discharge or at follow-up. During the follow-up, 19 (39%) patients died in the “Surgical” group and 2 (7%) among the “Catheter” patients. Conclusions: Transapical catheter-based closure of mitral paravalvular leak seems to be a safer treatment procedure than conventional re-do surgery, and the effectiveness of these procedures does not differ.

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.

Free floating mitral paravalvular leak closure device.

Free floating mitral paravalvular leak closure device.

Rate of transesophageal echocardiography related complications during 1229 TEE-guided structural heart disease procedures

Abstract Funding Acknowledgements Type of funding sources: None. Background/Introduction: Transesophageal echocardiography (TEE) has long provided excellent diagnostic imaging of left-sided valvular pathology with an excellent safety profile; however, recent data has suggested an increased risk of injury related to TEE guidance. Purpose This study aims to evaluate the incidence and nature of TEE-related oropharyngeal or esophageal complications in patients undergoing TEE-guided structural heart procedures and identify associated risk factors. Methods We reviewed consecutive patients undergoing TEE-guided structural heart procedures from 2005-2020. All procedures were performed under general anesthesia. TEE-related oropharyngeal or esophageal complications were defined as those occurring within 30 days of the procedure resulting in i) persistent dysphagia, odynophagia, or upper gastrointestinal bleeding requiring prolonged endotracheal intubation, therapeutic endoscopic or surgical intervention, or diagnostic imaging that demonstrated oropharyngeal or esophageal injury. ii) upper gastrointestinal bleed requiring transfusion, hemodynamic compromise warranting mechanical or pharmacologic support; or iii) oropharyngeal or esophageal complications leading to death. For multivariate analysis, all variables with a p &amp;lt; 0.15 at univariate analysis were included in the model. Results Among 1229 adult patients undergoing TEE-guided structural heart procedures between 2005-2020, 274 underwent a transcatheter aortic valve replacement (TAVR) with the remaining 955 undergoing either mitral valve transcatheter edge-to-edge repair (mTEER, n = 278), mitral paravalvular leak closure (PVLC, n = 354), mitral valve-in-valve replacement (VIV, n = 41), or left atrial appendage closure (LAAO, n = 282). Of these, 6 (0.5 %) had TEE-related complications; 0% TAVR, 0% VIV, 0.36% LAAO, 0.28% PVLC, 1.41% mTEER (p = 0.14). Of the six patients with complications 3 required at least one day of prolonged tracheal intubation and one a blood transfusion. None required surgical repair. Factors associated with increased complication risk (Table) included a prior history of gastrointestinal bleed (Odds ratio 5.44 [0.98-30.04; p = 0.05]) and longer procedural time (OR per 30 min 1.15 [1.01-1.31, p = 0.03]). Patients undergoing mTEER had an increased risk of complication (OR 6.76 [1.23-37.1 p = 0.03]) and longer procedural time (OR per 30 mins 1.15[1.01-1.31, p = 0.04]) compared to other all other procedures. Conclusion(s): In a large series of patients undergoing cardiac structural interventions under general anesthesia with TEE-guidance, rates of TEE-induced injury were low. Risk of oropharyngeal or esophageal complications was increased with longer procedure times, prior gastrointestinal bleeding history, increased age, increased pre-procedural creatinine, procedural type being mTEER and in male patients, lower height. Abstract Table

Percutaneous closure of multiple mitral paravalvular leaks

Percutaneous closure of multiple mitral paravalvular leaks

Multimodality cardiac imaging for guidance of transapical transcatheter aortic valve implantation and mitral paravalvular leak closure.

Multimodality cardiac imaging for guidance of transapical transcatheter aortic valve implantation and mitral paravalvular leak closure.

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.

Multimodality Cardiac Imaging for Procedural Planning and Guidance of Transcatheter Mitral Valve Replacement and Mitral Paravalvular Leak Closure.

Transcatheter mitral valve interventions are an evolving and growing field in which multimodality cardiac imaging is essential for diagnosis, procedural planning, and intraprocedural guidance. Currently, transcatheter mitral valve-in-valve with a balloon-expandable valve is the only form of transcatheter mitral valve replacement (TMVR) approved by the FDA, but valve-in-ring and valve-in-mitral annular calcification interventions are increasingly being performed. Additionally, there are several devices under investigation for implantation in a native annulus. Paravalvular leak (PVL) is a known complication of surgical or transcatheter valve implantation, where regurgitant flow occurs between the prosthetic sewing ring and the native mitral annulus. We sought to describe the role and applications of multimodality cardiac imaging for TMVR, and PVL closure, including the use of Cardiovascular Computed Tomography Angiography and 3-Dimensional Transesophageal Echocardiography for diagnosis, prosthetic valve evaluation, pre-procedural planning, and intraprocedural guidance, as well as evolving technologies such as fusion imaging and 3D printing.

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.

Three-dimensional echo guidance of percutaneous mitral paravalvular leak closure

Three-dimensional echo guidance of percutaneous mitral paravalvular leak closure

TCTAP A-114 New Technique of Transseptal Mitral Paravalvular Leak Closure with a Steerable Sheath (VALE Study)

TCTAP A-114 New Technique of Transseptal Mitral Paravalvular Leak Closure with a Steerable Sheath (VALE Study)

Peratrial Device Closure of Different Locations of Mitral Paravalvular Leaks

The current approaches of transcatheter closure of mitral paravalvular leak (MPVL) have different drawbacks. The challenges come from transseptal puncture, accessing the MPVL site, and the absence of dedicated delivery systems. This study introduces a novelperatrial approach for device closure of different locations of MPVLs using a probe-assisted delivery system under three-dimensional transesophageal echocardiography. A 4.0-cm minithoracotomy incision was made in the fourth right interspaces. The right atrium and the interatrial septum were punctured and dilated, followed by a guidewire passing through the septum. A specially designed J-shaped bendable hollow probe was advanced into the left atrium. The steerable probe was adjusted to cross the MPVL and introduced a stiff guidewire into the left ventricle. A 7F short delivery sheath was advanced over the wire through the MPVL into the left ventricle. A proper-sized muscular septal occluder was then selected and deployed. Transesophageal echocardiography revealed complete occlusion in 7 of 8 patients after a follow-up of 6 months to 4 years. Mild residual paravalvular regurgitation occurred in an early patient. In 2 patients with a crescent-shaped MPVL, two guidewires were advanced into the left ventricle across the leak, and double devices were deployed sequentially. All patients' symptoms improved by at least one New York Heart Association functional class. The peratrial technique can access and close MPVLs at different locations through a right minithoracotomy approach. This technique has the advantages of easy transseptal puncture, easy access to the MPVL site, and no exposure to radiation.