Treatment Of Paravalvular Leak Research Articles

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.

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.

Interventional treatment of para-valvular leaks after prosthetic valve replacement with plug devices -first results from a prospective registry

Abstract Background Interventional closure of symptomatic paravalvular leaks (PVL) after surgical or interventional valve replacement by plug implantation has emerged as an alternative to surgical correction, which is associated with high morbitity and mortality rates. To date, data on procedural efficacy and clinical outcome after transcatheter closure with plugs is sparse, especially prospective data are missing. Methods We analysed data from a multi-center prospective registry on interventional PVL closure with plug devices. Results Between 06/2012 and 04/2020 55 interventions were performed with different numbers of plugs (maximal 4) in 51 patients at 9 hospitals. Interventions were performed in 15 women and 36 men at high surgical risk for repeat surgery. 48% of procedures were performed for mitral PVLs and 52% procedures were performed for aortic PVLs. Mean age of the population treated was 69±13 years and mean log. Euro-Score I was 22.5±14.2%. Patients were treated by implantation of Amplatzer Vascular Plug III (80%) and Occlutec occluders (9%). Aortic PVLs were treated using a retrograde transfemoral access, mitral PVLs were treated using either a transseptal (25/26) or transapical access (1/26) with 3-dimensional transesophageal echocardiographic and fluoroscopic guidance. Indication for PVL closure was previous surgery (n=39), high-risk patients (n=24), heart failure (n=22), age (n=20) and hemolysis (n=12). 40 patients had NYHA class III/IV at admission. Interventional closure of PVL was completely successful in 40 procedures (73%), partially successful in 7 procedures (13%) and failed in 7 procedures (13%). NYHA class I/II after PVL closure was achieved in 75% patients. However, 8 out of 12 patients with hemolysis as indication still hemolyzed at discharge. Complications occurred in 16% of patients. In-hospital mortality rate was 4% of procedures (2/51). After hospital discharge no death occurred during 30-day follow-up. Conclusions In this prospective interventional PVL registry inclusion rate was lower than expected. There was an equal distribution of aortal and mitral PVLs. At least partial success could be achieved in 86% of patients, with significant functional improvement in most patients. In this high risk population hospital mortaliy was low (4%), indicating that interventional PVL treatment should be the treatment of choice, when discussed by a heart team. Funding Acknowledgement Type of funding sources: None.

Editorial comment: "Plug-In Hybrid"-Are we ready for this in heart valve surgery?

If we think about plug-in hybrids, the treatment of paravalvular leaks in cardiac surgery may not be the first thing that comes to mind. Yet, there appears to be an attractive analogy between the plug in hybrid car and an interventional device that may be "plugged in" intra-operatively to treat a paravalvular leak. Both technologies provide additional degrees of freedom to the fields, combine different technologies but may also be criticized for their increase in cost, introduction of new problems and their questionable practical need. We address this analogy based on a case series presented in this issue of the Journal of Cardiac Surgery.

Acute fulminant hemolysis after transcatheter mitral valve replacement for mitral annular calcification

Transcatheter mitral valve replacement (TMVR) is emerging as an alternative treatment strategy to surgery for patients with severe mitral annular calcification (MAC) who are not candidates for traditional mitral valve surgery. Paravalvular leak (PVL) is common following TMVR for severe MAC and can lead to heart failure symptoms and/or intravascular hemolysis, the latter of which usually is clinically stable. We report the case of a 67-year-old woman with symptomatic severe aortic stenosis and mitral stenosis with MAC in the setting of prior chest irradiation who was treated initially with transcatheter aortic valve replacement followed by TMVR at a later date (Sapien S3 system; Edwards Lifesciences). Immediately following TMVR, she developed acute profound hemolysis which manifested with hemoglobinuria, transfusion-dependent anemia, and acute renal failure requiring renal replacement therapy. She was treated with post-dilation balloon valvuloplasty after failed transcatheter PVL closure 10 days following TMVR with resulting improvement in the PVL. The hemolytic anemia resolved and renal function recovered without the need for continued hemodialysis 2 months later and stabilization of glomerular filtration rate at 6 months. This case highlights a potential severe complication of TMVR in MAC and suggests that improvement in hemolysis and late recovery of renal function may occur following treatment of PVL.

Transcatheter and Surgical Management of Mitral Paravalvular Leak: Long-Term Outcomes

ObjectivesThe aim of this study was to report the use trends and immediate and long-term outcomes of a large cohort of patients who underwent redo surgery or transcatheter repair of paravalvular leaks (PVLs) at a tertiary referral center. BackgroundPercutaneous treatment of mitral PVL has emerged as an alternative to surgical treatment in high-risk surgical candidates. There are limited data on the utilization trends, safety, and efficacy of both procedures in the management of mitral PVL. MethodsPatients who underwent treatment of mitral PVL at the Mayo Clinic between January 1995 and December 2015 were enrolled. Utilization trends, procedural details, technical success, and in-hospital and long-term outcomes were assessed. ResultsThree hundred eighty-one patients underwent percutaneous (n = 195) or surgical (n = 186) treatment of mitral PVLs. The mean age was 66 ± 12 years, and 37% of patients had bioprosthetic valves. Technical success was higher in the surgical group (95.5% vs. 70.1%; p < 0.001). In-hospital major adverse events were more common after surgery (22.5% vs. 7.7%; p < 0.001). In-hospital death occurred in 3.1% and 8.6% of patients undergoing percutaneous and surgical treatment, respectively (p = 0.027). However, in a multivariate logistic regression analysis, only active endocarditis, chronic renal failure, and severe mitral annular calcifications were significant predictors of in-hospital mortality. Reintervention rates were similar (11.3% vs. 17.2% in the percutaneous and surgical groups, respectively; p = 0.10), with the majority of reinterventions in the percutaneous group occurring early because of residual leak or persistent hemolysis. After risk adjustment, there was no significant difference in long-term survival between patients who underwent surgical versus transcatheter treatment of PVLs. ConclusionsIn contemporary practice, patients with symptomatic mitral PVLs are best treated with an integrated team approach incorporating both surgical and percutaneous techniques. Patient selection and timing of intervention are critical to achieve optimal results.

Outcomes After Paravalvular Leak Closure: Transcatheter Versus Surgical Approaches

ObjectivesThe aim of this study was to compare outcomes of transcatheter intervention (TI) versus surgical intervention (SI) for paravalvular leak (PVL). BackgroundData comparing the treatment of PVL with TI and SI are limited. MethodsA retrospective cohort study was conducted comparing baseline characteristics, procedural details, and 1-year survival in consecutive patients who underwent TI or SI for moderate or greater PVL from 2007 to 2016. The primary outcome was a composite of death, reintervention for PVL, or readmission for congestive heart failure–related symptoms at 1 year. ResultsOf 114 patients, 56 underwent TI and 58 underwent SI. PVL locations were mitral, aortic, and pulmonary in 69 (60.5%), 39 (34.2%), and 6 (5.3%) patients, respectively. At baseline, TI patients were older (age 71 vs. 62 years; p = 0.010) and had fewer cases of active endocarditis (0.0% vs. 25.9%, p < 0.001) than SI patients. The TI group had a shorter post-operative stay (4 vs. 8 days; p < 0.001), a shorter intensive care unit stay (0 vs. 3 days; p < 0.001), and fewer readmissions at 30 days (8.9% vs. 25.9%; p = 0.017). There were no differences in the primary endpoint (TI 33.9% vs. SI 39.7%; p = 0.526) or 1-year survival (TI 83.9% vs. SI 75.9%; p = 0.283) between groups. ConclusionsIn this study, TI for PVL closure had comparable 1-year clinical outcomes with SI, even after adjusting for differences in baseline characteristics, with less in-hospital morbidity and 30-day rehospitalization. Although further study is needed, these findings support the increased implementation of TI for PVL closure at experienced institutions.

Percutaneous Closure of Paravalvular Leaks: A Systematic Review.

Paravalvular leak (PVL) is an uncommon yet serious complication associated with the implantation of mechanical or bioprosthetic surgical valves and more recently recognized with transcatheter aortic valves implantation (TAVI). A significant number of patients will present with symptoms of congestive heart failure or haemolytic anaemia due to PVL and need further surgical or percutaneous treatment. Until recently, surgery has been the only available therapy for the treatment of clinically significant PVLs despite the significant morbidity and mortality associated with re-operation. Percutaneous treatment of PVLs has emerged as a safe and less invasive alternative, with low complication rates and high technical and clinical success rates. However, it is a complex procedure, which needs to be performed by an experienced team of interventional cardiologists and echocardiographers. This review discusses the current understanding of PVLs, including the utility of imaging techniques in PVL diagnosis and treatment, and the principles, outcomes and complications of transcatheter therapy of PVLs.

Long-term results after surgical treatment of paravalvular leak in the aortic and mitral position

ObjectivesThe aim of this study was to determine immediate results and long-term outcomes after surgical management of paravalvular leak (PVL). MethodsBetween 1995 and 2012, a total of 190 patients underwent primary surgical repair (n = 142) or valve replacement (n = 48) for a PVL at our institution. The PVL was mild in 6 (3%) patients, moderate in 85 (45%), moderate to severe in 84 (44%), and severe in 15 (8%). Among these, 120 (63%) had PVL in the mitral position, 63 (33%) had PVL in the aortic position, and 7 (4%) had PVL in both valves. Mean follow-up was 5.3 ± 4.6 years. ResultsMean age at surgery was 63 ± 12 years (64% men). Operative mortality occurred in 13 (7%) patients (10 [8%] in mitral; 2 [3%] in aortic; and 1 [14%] in double valve procedures). Survival at 1, 5, and 10 years was 85% ± 3%, 73% ± 4%, and 56% ± 5%, respectively. The cumulative incidence of PVL recurrence was 3% ± 1%, 14% ± 3%, and 32% ± 6%, at 1, 5, and 10 years, respectively. The number of previous surgeries was a predictor of survival and PVL recurrence. Freedom from New York Heart Association class ≥III was 96% ± 2%, 82% ± 4%, and 58% ± 6%, at 1, 5, and 10 years, respectively. The freedom from rehospitalization for heart failure was 92% ± 2%, 83% ± 4%, and 67% ± 6%, at 1, 5, and 10 years. ConclusionsSurgical treatment of PVL resulted in acceptable outcomes. Nevertheless, the continued risk of PVL recurrence is higher in patients who have had multiple previous surgeries. More studies are needed to compare these results with the transcatheter PVL reduction technique.

In vitro hemodynamic testing of Amplatzer plugs for paravalvular leak occlusion after transcatheter aortic valve implantation

ObjectiveWe aimed to in-vitro test Amplatzer devices (Amplatzer Vascular Plug II and Amplatzer Vascular Plug III, SJM, St. Paul, MN) in closing PVL generated by transcatheter balloon expandable aortic valve prosthesis in order to quantify the effective treatment of PVL. BackgroundTranscatheter aortic valve implantation (TAVI) procedures represent the treatment of choice for high risk patients. Despite evolving technologies paravalvular leak (PVL) is still a major unaddressed issue. This severe complication significantly impairs long-term survival. Percutaneous treatment of this complication is usually performed with the implantation of not specifically designed and not approved vascular devices. MethodsA 26mm Sapien XT (Edwards Lifesciences, Irvine, CA) was implanted in a rubber aortic root and a semi-elliptical shape PVL was created. The vascular occluder devices were implanted in the PVL and hemodynamic performance was tested in a pulse duplicator according to international standard ISO 5840-3:2013. Different type of comparison tests together with high speed camera recording allowed us to define the global efficiency of the occluders and their interaction with the transcatheter prosthesis. ResultsThe results revealed that the use of vascular plugs was not per se sufficient to produce an effective or substantial reduction of PVL with a maximum efficiency of less than 50%. Recorded video showed clearly that the vascular plug always interfered with the leaflet of the prosthetic valve. ConclusionsCurrently used devices do not guarantee effective treatment of PVL and may otherwise compromise the structural integrity of the prosthetic valve implanted. Specifically designed devices are required. Condensed abstractDespite evolving technologies, paravalvular leak (PVL) is still a major unaddressed issue after transcatheter aortic valve implantation. Percutaneous treatment of this complication is usually performed with the implantation of Amplatzer devices not specifically designed and not approved for this specific use. We tested Amplatzer devices in a pulse duplicator to occlude PVL generated after implantation of a 26mm SAPIENT XT prosthesis. The results revealed that the use of vascular plugs was not per se sufficient to produce an effective or substantial reduction of PVL. The video showed clearly that the vascular plug always interfered with the leaflet of the prosthetic valve.

Have we found the ideal plug for post‐TAVR paravalvular leaks?

Have we found the ideal plug for post‐TAVR paravalvular leaks?

Percutaneous treatment of paravalvular leaks after transcatheter aortic valve implantation with the CoreValve self-expanding bioprosthesis

Percutaneous treatment of paravalvular leaks after transcatheter aortic valve implantation with the CoreValve self-expanding bioprosthesis

Bioprosthetic Mitral Valve Endocarditis After Percutaneous Device Closure of Severe Paravalvular Leak

A large mitral paravalvular leak in a 63-year-old patient was closed by percutaneous placement of 2 Amplatzer Septal Occluder (AGA Medical Corporation, Plymouth, MN) devices. The patient had a residual paravalvular leak and subsequently developed infective endocarditis that was successfully treated by removal of all hardware and implantation of a new valve. Transcatheter treatment of paravalvular leaks may be useful in select patients who are poor candidates for open surgery; however, one must be aware of the potential complications. This report underscores the risk of device infection that may be increased if there is turbulence related to residual paravalvular leaks.

Paravalvular Aortic Leak After Transcatheter Aortic Valve Replacement

Transcatheter aortic valve replacement (TAVR) is now well-established as the standard of care for patients with severe symptomatic aortic stenosis who are deemed inoperable,1 and is seen as an alternative treatment option to surgical aortic valve replacement (SAVR) in a subset of patients with high postoperative mortality.2 The native valve is typically not removed but instead crushed by the superimposed bioprosthesis, which can result in an incomplete seal of the bioprosthetic valve and aortic annulus, with subsequent occurrence of paravalvular leak (PVL). Two types of Transcatheter Heart Valves (THV) that have been widely used, the balloon-expandable Edwards valve (Cribier-Edwards, Edwards SAPIEN and Edwards SAPIEN XT) by Edwards Lifesciences, and the self-expandable CoreValve by Medtronic, have been described in detail elsewhere.3,4 Despite the evolving technology of transcatheter valves, PVL post-TAVR is common, with a wide range of reported incidences (Table 1). Most importantly, PVL has been associated with increased short- and long-term mortality post-TAVR, and is seen as a barrier to more widespread use of this promising technique.5–13 This article describes the incidence, causes, and predictors of PVL, as well as its impact on clinical outcomes. Methods of prevention, diagnosis, and treatment of PVL are also reviewed. View this table: Table 1. TAVR Studies and Registries Reporting Incidence of PVL in >100 Patients Aortic regurgitation is characterized as either central or paravalvular. Pathological central regurgitation occurs in diseased native valves or damaged prosthetic valves, whereas minor central regurgitation is often a physiological feature of some bioprosthetic valves by virtue of their design. On the other hand, PVL is a complication only of aortic valve prostheses and occurs more commonly post-TAVR (Figure 1) than after SAVR. Figure 1. Parasternal longitudinal axis transthoracic echocardiography view showing mild paravalvular leak post–transcatheter heart valve deployment. Arrow indicates the site of paravalvular leak. Various multicenter …

Transcatheter prosthetic paravalvular leak closure

Summary Paravalvular leak affects up to 27% of all prosthetic heart valves implanted by conventional surgery. Patients with paravalvular regurgitation can be asymptomatic or may present with symptoms of congestive heart failure and/or haemolytic anaemia. Assessment and quantification of these paravalvular leaks are difficult since transthoracic colour flow Doppler images may be obscured by annular calcifications and prosthetic material. Surgical re-intervention is the conventional treatment of choice for severe cases but is associated with significant morbidity and mortality, and is not always successful because of underlying tissue fragility. Over the last decade, transcatheter treatment of paravalvular leaks has emerged as an attractive alternative to surgery for high-risk patients and is now favoured as the initial approach in some experienced centres. Transcatheter repair is technically feasible in 60 to 90% of cases according to different published series. Technical success is associated with clinical improvement in 50 to 90% of the cases.

Mitral Stenosis Caused by an Amplatzer Occluder Device Used to Treat a Paravalvular Leak

Paravalvular leaks following valve replacement can result in heart failure and hemolysis. Surgical intervention is the treatment of choice, but it carries substantial risk of morbidity and mortality. Percutaneous techniques using devices designed for congenital heart disease are increasingly applied to the treatment of paravalvular leaks. We present the case of a mitral paravalvular leak treated with an Amplatzer occluder device. Unfortunately, the device occluded flow through the mitral valve, resulting in symptomatic mitral stenosis requiring surgical intervention.

Treatment of paravalvular leaks through interventional techniques

Paravalvular leaks are a relevant complication after both surgical and interventional valve replacement. Approximately 1-5% of patients undergoing mitral or aortic valve replacement experience some sort of paravalvular leakage with varying clinical importance, ranging from asymptomatic to life-threatening. Repeated surgery has usually been considered the first choice to solve this problem, but this approach carries a high operative risk with mortality rates of up to 16% and an increased risk for re-leaks compared to the initial procedure. Transcatheter closure of paravalvular leaks using occluder devices has first been described in 1992. Since then, this technique slowly evolved with various technical improvements, being now a suitable alternative to redo-surgery in patients at high surgical risk with appropriate defect geometries. Particularly the introduction of specifically designed devices as well as improved imaging tools such as three-dimensional real-time echocardiography facilitate the procedure, likely to play an increasingly important role in the future.

Diagnostyka i leczenie przezskórne pacjentów z przeciekami okołozastawkowymi

Diagnostyka i leczenie przezskórne pacjentów z przeciekami okołozastawkowymi

Closure of prosthetic paravalvular leaks: a long way to go

Cardiac valve replacement, albeit a well-established and safe procedure, is associated with a significant risk of complications. Symptomatic paravalvular leak (PVL) is a significant post-operative complication of cardiac valve replacement. The prevalence of this complication along with the long-term significance of asymptomatic leaks remains unknown. When these patients develop worsening heart failure or severe haemolysis that requires multiple transfusions from paravalvular regurgitation, the current recommendation is for closure of the leak. The recommended approach has been surgical closure until transcatheter techniques were introduced by Hourihan et al .1 There have been significant innovations in occlusive devices over the past 20 years; however, there are no specifically designed device(s) for the treatment of PVLs. Percutaneous device closure of PVLs has become an attractive alternative to surgical closure. This has further been enhanced by the ability to integrate multi-imaging modalities that have helped to define the pre-operative anatomy as well as to plan and guide the percutaneous closure procedure, resulting in improved outcomes. Since no single imaging modality has the capability to provide all the crucial information that is required for percutaneous closure of PVLs, in our centre we utilize an integrated multiple imaging modalities within a bi-plane cardiac catheterization laboratory. The following modalities assist in the assessment and guidance of percutaneous closure of PVLs. ### Echocardiography Echocardiography is a multifaceted tool used for the diagnosis, quantification, and guidance of treatment of paravalvular prosthetic valve leaks. ### Diagnosis Two-dimensional (2D) echocardiography with spectral and colour Doppler flow images are frequently used for the non-invasive diagnosis of PVLs. Transthoracic echocardiography (TTE) in various imaging planes obtained from the parasternal, apical, subxyphoid, and suprasternal windows helps to define the site of the leak ( Figure 1A ). However, the jet of prosthetic valvular and/or PVL may be overshadowed by the prosthetic valve, thus underestimating the degree of leak …