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Repair of Prosthetic Mitral Valve Paravalvular Leak Using an OffPump Transapical Approach Vinod H. Thourani, MD, Colleen M. Smith, BA, Robert A. Guyton, MD, Peter Block, MD, David Liff, MD, Patrick Willis, MD, Stamatios Lerakis, MD, Chesnal D. Arepalli, MD, Sharon Howell, RDCS, Bryon J. Boulton, MD, James Stewart, MD, and Vasilis Babaliaros, MD Division of Cardiothoracic Surgery, Joseph B. Whitehead Department of Surgery; Division of Cardiology, Department of Medicine; and Department of Cardiothoracic Imaging, Emory University School of Medicine, Atlanta, Georgia Patients who present with significant paravalvular regurgitation after mitral valve replacement remain a difficult patient population and high-risk surgical candidates. We present 3 cases of transapical closure of mitral valve paravalvular leak (PVL) after mitral valve replacement using Amplatzer closure devices (AGA Medical Corp, Plymouth, MN). All 3 patients experienced decreased regurgitation at the site of the closure as well as symptomatic improvement in their heart failure. (Ann Thorac Surg 2012;94:275–78) © 2012 by The Society of Thoracic Surgeons A lthough uncommon, paravalvular leak (PVL) of previously replaced mitral valves has a reported incidence of 3% to 12.5%. Most leaks become apparent in the first 6 months after the original procedure, but many patients remain asymptomatic and do not require further surgical intervention. However symptomatic patients often have associated heart failure, hemolytic anemia, arrhythmias, and infective endocarditis [1]. Many patients with symptomatic PVL will benefit from a second surgical intervention by sternotomy or right thoracotomy for repair of the PVL or replacement of the valve in patients with an unstable prosthesis. However in patients considered very high risk for an open surgical procedure, the best method of treatment for mitral valve PVL remains a difficult clinical scenario. An alternative technique for repair of the anterolateral mitral valve PVL in this patient population has been the transfemoral approach. For some patients with a PVL in the posterolateral or posteromedial (septal) portion of the mitral valve prosthesis, access to the defect using the transfemoral approach is particularly difficult. Here we present 3 high-risk patients with mitral valve PVLs who underwent repair using a transapical ap- Accepted for publication Dec 6, 2011. Address correspondence to Dr Thourani, Division of Cardiothoracic Surgery, Joseph B. Whitehead Department of Surgery, Emory University Hospital Midtown, 550 Peachtree St, 6th Flr, Medical Office Tower, Atlanta, GA 30308; e-mail: [email protected]. © 2012 by The Society of Thoracic Surgeons Published by Elsevier Inc CASE REPORT THOURANI ET AL TRANSAPICAL MV PARAVALVULAR LEAK REPAIR 275 proach with Amplatzer ventricular septal defect (VSD) or patent ductus arteriosus occluders. Case Reports Surgical Technique Initially, femoral venous and arterial access was obtained using 6F catheters. The patients then underwent an epicardial ultrasonographically guided left minithoracotomy incision. Two U mattress sutures were placed in the anterolateral portion of the heart, close to the second diagonal coronary artery. Left ventricular access was achieved and a 0.035-inch Terumo wire was used to cross the PVL into the left atrium. A 14F sheath was placed within the left atrium followed by 2 Amplatz extra-stiff wires (0.035 inch). Care was taken to land the tips of these wires within the left atrium and not into the pulmonary veins. Although a 14F sheath is not always required, it is helpful when placing 2 Amplatzer devices simultaneously. Intraoperative transesophageal echocardiography (TEE) was used to guide crossing of the PVL, sizing of the PVL with angioplasty balloon, placement of the Amplatzer device, and assessment of resolution of the PVL before closure (Fig 1). All procedures were performed without cardiopulmonary bypass and all patients were extubated on postoperative day 0. Patient 1 Our first patient was a 61-year-old woman with a history of rheumatic heart disease, transient ischemic attack, hypertension, atrial fibrillation, and a mechanical mitral valve, who had previously undergone 3 mitral valve replacements (1 with concomitant aortic valve replacement). She presented with New York Heart Association (NYHA) class IV heart failure and severe hemolytic anemia and was found to have a PVL on the posterolateral mitral valve annulus by TEE. A transfemoral transcatheter approach was initially attempted to repair the PVL, but the attempt was aborted because of the unfavorable angulation of the pathway of the leak across the bioprosthesis into the left ventricle. The patient was then taken to the hybrid operating room, where a transapical approach was used to repair the leak with a 6-mm Amplatzer VSD occluder device, after which the leak showed a decrease from ⫹4 to ⫹2, and 3-dimensional (3D) TEE showed the device to be correctly deployed. Postoperatively the patient required blood transfusions and was given erythropoietin for her hemolytic anemia. Follow-up echocardiograms documented decreasing PVL until 9-month follow-up when no residual leak was noted and the hemolytic anemia had resolved. The patient experienced a decrease in her NYHA symptoms from class IV at the time of operation to class II by the 20-month follow-up. Patient 2 Patient 2 was a 59-year-old woman with a history of morbid obesity, insulin-dependent diabetes mellitus 0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2011.12.035 FEATURE ARTICLES Ann Thorac Surg 2012;94:275–78 276 CASE REPORT THOURANI ET AL TRANSAPICAL MV PARAVALVULAR LEAK REPAIR Ann Thorac Surg 2012;94:275–78 Fig 1. Fluoroscopy demonstrating (A) positioning of the ventricular septal defect (VSD) closure device (arrow), (B) left atrial deployment (arrow), (C) left ventricular deployment (arrow), and (D) final results (arrow). FEATURE ARTICLES type 2, hypertension, and a porcine mitral valve and had previously undergone 2 mitral valve replacements. She presented with NYHA class III heart failure and was found to have a severe posteromedial mitral valve PVL by TEE (Fig 2A). This patient was at high risk of morbidity with redo sternotomy; furthermore the location of her PVL as well as her obesity made a transfemoral percutaneous approach unlikely to be successful. Therefore she Fig 2. (A) Transesophageal echocardiography (TEE) showing preoperative paravalvular leak (PVL). (B) TEE showing postoperative PVL. (C) Three-dimensional TEE showing postoperative double device closure (solid and dashed arrow). Ann Thorac Surg 2012;94:275–78 underwent a transapical repair of the leak using both a 10-mm Amplatzer VSD occluder device and a 12-mm/ 10-mm Amplatzer patent ductus arteriosus occluder device. Intraoperative 3D TEE demonstrated a decrease in the PVL from severe to mild and showed that both devices were appropriately located (Figure 2B and C). At 3-month follow-up, the patient’s symptoms of heart failure had decreased from NYHA class IV to class II. Patient 3 277 with symptoms of NYHA class IV heart failure and was found to have a severe posteromedial mitral valve PVL adjacent to the atrial septum as well as a mild anterolateral jet seen by TEE and cardiac magnetic resonance imaging (MRI) (Fig 3A and B). Because of the severe leak’s location in proximity to the atrial septum and the history of severe mitral annular calcification, a transapical approach was deemed the more appropriate surgical option. Repair was performed using a 10-mm Amplatzer VSD occluder device. Intraoperative TEE demonstrated a decrease in severity of the PVL from severe to minimal, with an appropriately positioned device (Fig 3C). At discharge the patient’s symptoms of heart failure had decreased from NYHA class IV to class I. A postoperative cardiac MRI demonstrated no evidence of PVL at the site of the Amplatzer device, although it continued to demonstrate a mild PVL at the lateral mitral valve annulus (Fig 3D). At the 6-month follow-up, the patient was in FEATURE ARTICLES Our third patient was a 53-year-old man with a history of hypertension and a porcine mitral valve who had previously undergone concomitant mitral valve replacement and coronary artery bypass of a saphenous vein graft to the posterior descending coronary artery. He had a history of a heavily calcified posterior mitral valve annulus, and successful replacement of his valve was considered unlikely with another open operation. He presented CASE REPORT THOURANI ET AL TRANSAPICAL MV PARAVALVULAR LEAK REPAIR Fig 3. (A) Preoperative cardiac magnetic resonance imaging (MRI) (true fast imaging with steady state precession [trueFISP] image) showing posteromedial paravalvular leak (PVL) (arrow). (B) Preoperative transesophageal echocardiography (TEE) showing severe posteromedial PVL (solid arrow) and mild anterolateral PVL (dashed arrow). (C) Postoperative TEE showing VSD device closure of posteromedial PVL (arrow). (D) Postoperative cardiac MRI (trueFISP image) showing closed posteromedial PVL (solid arrow) and persistent anterolateral PVL (dashed arrow). 278 CASE REPORT THOURANI ET AL TRANSAPICAL MV PARAVALVULAR LEAK REPAIR NYHA class I, but on follow-up MRI his PVL in the anterolateral aspect of the mitral valve had increased to moderate, although he had no evidence of PVL at the site of repair. Comment FEATURE ARTICLES The American Heart Association consensus guidelines include a class I recommendation for mitral valve surgical procedures in patients with chronic, severe mitral regurgitation and NYHA functional class II, III, or IV symptoms in the absence of severe left ventricular dysfunction [2]. In stable patients with prosthetic valve dysfunction, repeated traditional mitral valve replacement is the recommended treatment for PVL. However reoperation for repair of PVL is associated with higher morbidity and mortality than the original procedure, with in-hospital mortality rates of 13%, 15%, and 37% for the first, second, and third reoperations, respectively [3]. In addition, each reoperation carries an increased risk of recurrence of the leak. Therefore alternative approaches may be considered in patients who have undergone multiple sternotomies, have hostile mediastinum, have a history of coronary artery bypass grafts that cross the midline, have other significant risk factors that preclude a repeated sternotomy, or who cannot tolerate cardiopulmonary bypass. The most common alternative approach remains the percutaneous transfemoral transseptal repair [1]. When performing a transfemoral mitral valve PVL repair, an antegrade transseptal or retrograde (through the aortic valve) approach, or both, may be used. This technique avoids a thoracotomy and has been performed with technical success rates of 60% to 90% in selected patients [1]. It is of note that a retrograde approach is precluded in patients who have received a previous mechanical aortic valve. Limited data exist on the outcomes of transfemoral mitral valve PVL repairs; with available series reporting at most 10 to 27 patients [1, 4, 5]. These series show success in eliminating or reducing the PVL, leading to improvement of heart failure symptoms. Hemolytic anemia was reported to have resolved in 60% to 83% of patients [1]. A small number of patients who did not require blood transfusions before the procedure manifested transfusion-dependent hemolytic anemia after placement of the PVL closure device. There are some additional reports of adverse outcomes after transfemoral catheter repair of PVLs, including stroke, arrhythmia, cardiac perforation, interference of the new device with function of the mitral valve, late device dislodgement, and renal failure [1, 5–7]. In the event of inadequate closure, a second transcatheter attempt can be made or patients can undergo definitive surgical intervention at no increased risk after the catheterization. Very few reports are available describing the transapical approach as used in our patients [7, 8]. These cases suggest that posterior and septal mitral Ann Thorac Surg 2012;94:275–78 valve PVL are difficult to approach transfemorally and therefore a transapical approach may be preferred. The transapical approach provides direct access to the mitral valve and avoids traversing the aorta or aortic valve. Other advantages to this approach are that it allows for the passage of a larger catheter so that multiple devices can be deployed simultaneously to close large defects. Secondary to the direct approach, these cases can be performed in less than 1 to 2 hours and may result in less fluoroscopy time. Importantly, there are very few perioperative deaths reported as a result of transcatheter PVL repair despite the fact that it is commonly attempted in more high-risk patients [1]. None of the available reports of PVL repair using the transapical approach indicate perioperative mortality. Although the outcomes of both transfemoral and transapical approaches are similar, these procedures could benefit from the development of specific devices to facilitate leak closure. These results suggest that for select patients, transapical repair is a safe and effective option for treatment of symptomatic mitral valve prostheses PVL. Although this technique should not substitute for open surgical repair of mitral valve PVL in low- or medium-risk patients or in those with an unstable prosthesis, it does provide physicians an alternative treatment for this difficult high-risk patient population. References 1. Latson LA. Transcatheter closure of paraprosthetic valve leaks after surgical mitral and aortic valve replacements. Expert Rev Cardiovasc Ther 2009;7:507–14. 2. Bonow RO, Carabello BA, Chatterjee K, et al. 2008 Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease). Circulation 2008;118:e523– 661. 3. Echevarria JR, Bernal JM, Rabasa JM, Morales D, Revilla Y, Revuelta JM. Reoperation for bioprosthetic valve dysfunction. A decade of clinical experience. Eur J Cardiothorac Surg 1991;5:523– 6. 4. Shapira Y, Hirsch R, Kornowski R, et al. Percutaneous closure of perivalvular leaks with Amplatzer occluders: feasibility, safety, and shortterm results. J Heart Valve Dis 2007;16:305–13. 5. Moscucci M, Deeb GM, Bach D, Eagle KA, Williams DM. Coil embolization of a periprosthetic mitral valve leak associated with severe hemolytic anemia. Circulation 2001; 104:E85– 6. 6. Ussia GP, Scandura S, Calafiore AM, et al. Images in cardiovascular medicine. Late device dislodgement after percutaneous closure of mitral prosthesis paravalvular leak with Amplatzer muscular ventricular septal defect occluder. Circulation 2007;115:e208 –10. 7. Lim DS, Ragosta M, Dent JM. Percutaneous transthoracic ventricular puncture for diagnostic and interventional catheterization. Catheter Cardiovasc Interv 2008;71:915– 8. 8. Lang N, Kozlik-Feldmann R, Dalla Pozza R, et al. Hybrid occlusion of a paravalvular leak with an Amplatzer septal occluder after mechanical aortic and mitral valve replacement. J Thorac Cardiovasc Surg 2010;139:221–2.