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Prosthetic Heart Valve Solutions | St. Jude Medical

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Paravalvular leaks (PVLs) are a well-recognized complication of mechanical or bioprosthetic surgical valve replacement. It is estimated that more than 60,000 patients per year undergo surgical heart valve replacement in the United States, with a reported incidence of 5% to 15% for some form of PVL.1 Most PVLs are small and clinically benign; however, larger PVLs can manifest in heart failure or hemolysis, necessitating either surgical or percutaneous repair.2 Although surgical repair has historically been the standard treatment for severe PVLs, “re-do” surgery confers increased morbidity and mortality; therefore, development of less-invasive percutaneous PVL closure techniques has gained momentum within the field of structural interventional cardiology.

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Despite medical therapies, however, many patients will continue to experience worsening NYHA functional class and intractable hemolytic anemia, necessitating reoperation. Unfortunately, repeat surgery is often unsuccessful, with a high incidence of recurrence as the original anatomical problems persist, resulting in reformation of PVLs.8 Furthermore, these patients are generally sicker than at the time of the index surgical procedure, and therefore, reoperation carries markedly higher morbidity and mortality rates (Table 1). In a case series by Akins et al, a total of 136 patients underwent surgical correction of a PVL (32% aortic and 68% mitral, 48% primary repair and 52% replacement of prosthesis), and the operative mortality and preoperative stroke rates were 6.6% and 5.1%, respectively.4 Ten-year mortality in that series was 70%, with similar perioperative and long-term mortality rates reported by other investigators.5,6

Mechanical Heart Valves | St. Jude Medical

The first successful transcatheter closure of PVLs was reported by Hourihan and colleagues in 1992 with the use of the Rashkind double-umbrella closure technique. 9 No specific device has since been developed or approved by the US Food and Drug Administration for percutaneous PVL repair. Therefore, the choice of percutaneous therapeutic options is limited to the offlabel use of closure devices designed for repair of other cardiac defects. The Amplatzer family of closure devices (St. Jude Medical, Inc., St. Paul, MN), including the septal occluder, VSD muscular occluder, duct occluder, and vascular plugs, has gained favor and are the devices most commonly used off-label for transcatheter PVL repair.10 In the United States, the Amplatzer Vascular Plugs (AVP) II and IV (St. Jude Medical, Inc.) are commonly used. The AVP IV has the advantage of being delivered through a 0.038-inch diagnostic catheter lumen and can be placed in very serpiginous and longtunnel PVLs, such as those that occur after transcatheter aortic valve replacement. The AVP III device (St. Jude Medical, Inc.) has a thin rectangular shape that is designed to conform to a crescent-shaped PVL defect and has been used with success, although it is not currently available in the United States. Device selection and sizing requires careful examination of the PVL anatomy, specifically the diameter and length of the defect, and its relationship to the surrounding cardiac structures.

In the majority of patients, PVLs occur within the first 6 months after surgical valve replacement. Infective endocarditis is the most common cause of PVL and is more prevalent in patients undergoing valve replacement for active native valve endocarditis, with a risk ranging from 0.06% to 5.4%.2 Anatomically speaking, one factor leading to PVL is thinning of the mitral valve annulus due to myxomatous degeneration, resulting in an increased risk of stitch dehiscence. Furthermore, annular calcification may cause suture breakage or prevention of appropriate apposition of the prosthetic ring to the tissue annulus, leading to dehiscence and PVL. Prosthesis and annular size mismatch, especially in a markedly dilated left ventricle, can cause retraction of the valve annulus ring away from the prosthesis, contributing to PVL formation.

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The antegrade approach is performed via a transseptal puncture in the usual fashion with a BRK needle (St. Jude Medical, Inc.) and a Mullins sheath (Medtronic, Inc., Minneapolis, MN) through which a diagnostic catheter is then advanced into the left atrium. A Terumo floppy Glidewire is used to cross the paravalvular defect, and the diagnostic catheter is advanced over the wire into the left ventricle. The floppy Glidewire can then be exchanged for a more supportive wire. The Mullins sheath is then exchanged for the device delivery sheath, which is used to deploy the closure device within the defect. An arteriovenous loop can be used if additional support is required by directing the Terumo floppy Glidewire from the left ventricle out to the level of the descending aorta and subsequently snaring and externalizing the wire through the femoral arterial sheath.

T1 - Echocardiographic diagnosis of incomplete St. Jude's bileaflet valvular closure after mitral valve replacement with subvalvular preservation

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  • Aortic and mitral valve replacement with the St

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In a separate series by Ruiz et al,12 57 percutaneous PVL closures were performed in 43 patients, of which, 84% had congestive heart failure and predominantly involved the mitral prosthesis (n = 38). Procedural success was achieved in 86% of the patients, with 28 of 35 patients improved by at least 1 NYHA functional class. No periprocedural death was reported, and the survival rates for patients at 6, 12, and 18 months after PVL closures were 91.9%, 89.2%, and 86.5%, respectively.

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At our institution, percutaneous repair of PVL is generally a first-line approach to these patients if it is believed to be technically feasible. A 61-year-old man was referred to our institution with NYHA class II to III with a dilated left atrium, atrial fibrillation, and systolic dysfunction (left ventricular ejection fraction, 40%). The patient was initially well until 2007, when he presented with severe shortness of breath and was found to have acute heart failure from a ruptured chord. He underwent emergent repair but had recurrent mitral regurgitation in 2009, necessitating mitral valve replacement with a Carbomedics valve (Sorin Group, Milan, Italy). Echocardiography demonstrated a significant 3+ PVL located lateral and anterior to the valve. Laboratory findings demonstrated anemia consistent with mild hemolysis (hemoglobin, 12.6 g/dL; lactate dehydrogenase, 322 U/L; haptoglobin, 1 mg/dL). Given the patient’s two previous sternotomies and higher risk for reoperation, he was referred for percutaneous repair of the PVL after informed consent was obtained.

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Besides the usual complications related to percutaneous interventions, including thromboembolic events, iatrogenic cardiac injury, and vascular complications, several complications are inherent to transcatheter closure of PVLs. Impingement of the prosthetic valve leaflet during systole can prevent proper valve closure, leading to a sudden increase in the regurgitant volume. A more feared complication is obstruction of a mechanical tilting-disk valve, which may be pulled shut after device deployment or tilting of the closure device after deployment, blocking prosthetic valve leaflets.14 Other complications include device embolization, bioprosthetic leaflet erosion, or complete heart block due to deployment of a closure device at the level of the junction of the interventricular and interatrial septum that houses the atrioventricular node.

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T1 - Comprehensive hemodynamic assessment of 368 normal St. Jude Medical mechanical mitral valve prostheses based on early postimplantation echocardiographic studies

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