“…Open surgical correction for the treatment of PVL is associated with high morbidity, mortality, and recurrent PVL ( 5 ). The advent of advanced percutaneous skills and imaging modalities has allowed transcatheter PVL closure to evolve.…”
Section: Discussionmentioning
confidence: 99%
“…Although a variety of endovascular plugs have been tested, none are approved by the FDA for PVL closure. Among commercially available products, the Amplatzer family of plugs (St Jude Medical/Abbott Vascular) have been used most commonly with variable success and operator experience ( 1 , 3 , 5 , 7 , 8 ). Incomplete PVL closure resulting in heart failure and refractory hemolysis remains the most important limitation; this is particularly true among large complex PVL defects, in which multiple plugs are required.…”
Section: Discussionmentioning
confidence: 99%
“…Transcatheter PVL closure was introduced as a less invasive alternative to surgery ( 3 , 4 , 5 ), and is presently accepted as a Class IIa recommendation by the American Heart Association/American College of Cardiology for higher-risk patients with symptomatic heart failure and/or intractable hemolysis ( 6 ). Despite this, there are presently no U.S. Food and Drug Administration (FDA)–approved PVL closure devices, and although the body of evidence involves the use of fenestrated closure devices, incomplete closure and refractory hemolysis often limits their success ( 5 ). …”
A variety of fenestrated vascular plugs have been used to seal paravalvular leaks with meaningful success; however, incomplete closure and refractory hemolysis remains a common problem. We describe the feasibility and rationale of their first experience using a nonfenestrated Cardioform Septal Occluder (Gore Medical, Flagstaff, Arizona) to treat a giant mitral paravalvular leak. (
Level of Difficulty: Advanced.
)
“…Open surgical correction for the treatment of PVL is associated with high morbidity, mortality, and recurrent PVL ( 5 ). The advent of advanced percutaneous skills and imaging modalities has allowed transcatheter PVL closure to evolve.…”
Section: Discussionmentioning
confidence: 99%
“…Although a variety of endovascular plugs have been tested, none are approved by the FDA for PVL closure. Among commercially available products, the Amplatzer family of plugs (St Jude Medical/Abbott Vascular) have been used most commonly with variable success and operator experience ( 1 , 3 , 5 , 7 , 8 ). Incomplete PVL closure resulting in heart failure and refractory hemolysis remains the most important limitation; this is particularly true among large complex PVL defects, in which multiple plugs are required.…”
Section: Discussionmentioning
confidence: 99%
“…Transcatheter PVL closure was introduced as a less invasive alternative to surgery ( 3 , 4 , 5 ), and is presently accepted as a Class IIa recommendation by the American Heart Association/American College of Cardiology for higher-risk patients with symptomatic heart failure and/or intractable hemolysis ( 6 ). Despite this, there are presently no U.S. Food and Drug Administration (FDA)–approved PVL closure devices, and although the body of evidence involves the use of fenestrated closure devices, incomplete closure and refractory hemolysis often limits their success ( 5 ). …”
A variety of fenestrated vascular plugs have been used to seal paravalvular leaks with meaningful success; however, incomplete closure and refractory hemolysis remains a common problem. We describe the feasibility and rationale of their first experience using a nonfenestrated Cardioform Septal Occluder (Gore Medical, Flagstaff, Arizona) to treat a giant mitral paravalvular leak. (
Level of Difficulty: Advanced.
)
Background: Paravalvular leaks (PVLs) occur in up to 17% of patients after valve replacement. Due to the high morbidity and mortality associated with re-operation, percutaneous transapical (TA) closure has been introduced as an alternative to the surgical repair and percutaneous transcatheter closure in the treatment of PVLs. Here, we evaluated the outcomes of patients who underwent TA-closure for PVLs at the our centre.Methods: This study analyzed records of 12 patients with 13 problematic mechanical valves who underwent treatment at our hospital from April 2015 to November 2018. All procedures were performed under general anesthesia, with preoperative CT reconstruction and guidance by three-dimensional transesophageal echocardiography (3D-TEE). Results: Our data showed that all the TA punctures were successful with delivery sheath sizes that ranged from 5-7 Fr. Out of the 13 valves, 10 were single leaks (76.9%) and were all closed by a single occluder. There were 2 double leaks (15.3%) which were closed by two single bigger devices, while the remaining double leak was corrected by two separate devices. The median duration of the procedure was 82 minutes (IQR, 65-85 minutes). In addition, the mean postoperative ICU stay was 4 days (IQR, 1-2 days) and mean duration from procedure to hospital discharge was 7 days (IQR, 4-7 days). One patient died prior to the discharge. Conclusion: Taken together, our data demonstrates that percutaneous TA is safe and is associated with a low complication rate and procedure-related mortality. Multiple leaks and diameter of ≥ 10 mm might increase the risk for residual regurgitation.
“…1 Metallic occlusive devices have been developed to percutaneously occlude vessels or intracardiac openings, such as atrial or ventricular septal defects. 2 These devices have then been adopted to address paravalvular leaks (PVL) in patients that have high operative risks. 3 The first descriptions of such techniques date back to the early 90 s. 4 To address PVL in patients undergoing conventional (mostly redo) surgery, different surgical options exist for even challenging situations.…”
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.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.