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SURGICAL TECHNIQUE ___________________________________________________________

Management of Transcatheter Aortic Valve Embolization into the Left Ventricle Lynda Otalvaro, M.D.,* Abdulla Damluji, M.D., MPH,* Carlos E. Alfonso, M.D.,* Donald B. Williams, M.D.,y and Alan W. Heldman, M.D.* *Cardiovascular Division and the Elaine and Sydney Sussman, Cardiac Catheterization Laboratory, Miami, Florida; and yDivision of Cardiothoracic Surgery, Department of Surgery, University of Miami Miller School of Medicine, Miami, Florida ABSTRACT Embolization of transcatheter aortic valve replacement (TAVR) prostheses is a rare and serious procedural complication. While embolization into the aorta can sometimes be managed by transcatheter techniques, embolization into the left ventricle (LV) often requires immediate open heart surgery. We report three TAVR cases complicated by LV embolization. In each case, successful implantation of a second transcatheter prosthesis was accomplished, followed by surgical removal of the first embolized device. doi:

10.1111/jocs.12475 (J Card Surg 2015;30:360–363) Transcatheter aortic valve replacement (TAVR) may rarely be complicated by transcatheter heart valve (THV) embolization.1–3 We report our experience managing left ventricular embolization in three cases. The Institutional Review Board of the University of Miami Miller School of Medicine approved reporting these cases. Case #1 A 79-year-old male with severe symptomatic aortic stenosis (AS), prior coronary bypass grafting, and recent stenting of the left main coronary presented with acute congestive heart failure. Echocardiography showed an aortic valve area of 0.7 cm2, mean gradient 57 mmHg, and LV ejection fraction 0.55–0.60. The Society of Thoracic Surgeons predicted risk of operative mortality (STS score) for surgical aortic valve replacement (SAVR) was 7.0 %. Transfemoral TAVR was done by predilation with a 23 mm balloon (Z-Med, B/Braun interventional system, Bethlehem, PA, USA) followed by implantation of a 26 mm Edwards SAPIEN Valve

Conflict of interest: Drs. Heldman and Williams–research support, Edwards LifeSciences. The authors would like to acknowledge the following physicians for their assistance in the care of our patients and program development: Dr Mauricio G. Cohen, Dr Roger G. Carrillo, Dr Claudia A. Martinez, and Dr Eduardo de Marchena. Drs. Otalvaro & Damluji contributed equally to this manuscript. Address for correspondence: Alan W. Heldman, M.D., Cardiovascular Division, University of Miami Miller School of Medicine, Clinical Research Building, 1120 NW 14th Street, Suite 1118, Miami, Florida 33136. Fax: þ305-243-1731; e-mail: [email protected]

using the Retroflex delivery system (Edwards Lifescience, Irvine, CA, USA). After deployment, the valve was ‘‘low’’ (i.e., mostly on the LV side of the native annulus), and there was severe regurgitation (Movie 1). Deployment of a second, valve-in-valve prosthesis was planned. During delivery of this second device, the first valve was dislodged and migrated into the left ventricle (Fig. 1). Decision making included plans to 1) attempt to keep the embolized valve on the guidewire, and 2) deploy the second valve in the normal position. Both of these were accomplished, and there was mild residual aortic valve regurgitation. The transfemoral device’s sheath was exchanged for an arterial cannula, and femoral cardiopulmonary bypass was established. Through a right thoracotomy, the patient’s heart was fibrillated transiently, then Waterston’s groove was opened into the left atrium to expose the mitral valve. Through the mitral valve, the embolized device was identified in the left ventricle and was reoriented onto the surgeon’s finger to ensure it was not entangled in the mitral apparatus. The device’s frame was crushed in the LV using a large clamp and then was removed through the mitral valve. Intraaortic balloon pumping (IABP) was used during separation from cardiopulmonary bypass. Following surgery, echocardiography showed the second TAVR was in good position mild aortic insufficiency (AI). His 22-day hospitalization was complicated by right diaphragmatic paralysis, pneumonia, acute kidney injury (AKI), and complete atrioventricular block. A permanent pacemaker was implanted and he was discharged to a rehabilitation facility. At a 24-month follow-up visit,

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Figure 1. Deployment of second valve. First THV embolized distally in patient #1

he had New York Heart Association (NYHA) functional class I exercise tolerance and echocardiographic mild AI. Case #2 A 67-year-old male had severe symptomatic AS, morbid obesity, and severe obstructive pulmonary disease. He presented with a rapid decline in functional capacity. Echocardiography showed an aortic valve area of 0.6 cm2, mean gradient 46 mmHg, and LV ejection fraction of 0.55–0.60. The STS score was 1.0 %; however, because of dense ascending aortic calcification, SAVR was not feasible and TAVR was planned. Computed tomography (CT) angiography showed the average diameter of the aortic valve annulus was 26 mm. Transfemoral TAVR was performed over an Amplatz Extra-Stiff guidewire (Cook Medical, Bloomington, IN, USA); the native valve was dilated with a 23 mm balloon, followed by implantation of a 26 mm Edwards Sapien valve during rapid ventricular pacing. During expansion of the valve, it migrated inferiorly into the left ventricular outflow tract (LVOT) below the level of the native valve and could not be pulled back into position. Despite this, the patient remained hemodynamically stable (Fig. 2A). We decided to treat the patient with a second valve; however, during advancement of the second device the first valve embolized into the left ventricular outflow tract. In this case, we again maintained the embolized valve on the guidewire and deployed the second valve successfully at the aortic annulus. Aortography showed minimal paravalvular aortic regurgitation. The embolized valve in the LV remained on the guidewire (Fig. 2B). In part because the chest was very large, we approached this problem via median sternotomy. There was massive left ventricular hypertrophy and heavy calcification of the aorta. Femoral cardiopulmonary bypass was initiated. The heart was fibrillated and the left atrium was opened; the atrium was very small and, together with the patient’s size, made visualization of the mitral valve impossible. The aorta was cross-clamped and cold cardioplegia was

Figure 2. (A) Embolization into the LVOT in patient #2. (B) Deployment of second THV. First valve on the guidewire.

given. An apical left ventriculotomy was made and the valve was easily identified and removed. There were no major complications in hospital and he was discharged home. At a four-month follow-up visit, he was doing well with NYHA functional class II exercise tolerance and no echocardiographic AI. Case #3 An 80-year-old male with severe symptomatic AS, two prior coronary bypass surgeries, LV systolic dysfunction and heart failure, type II diabetes mellitus, chronic kidney disease, and a recent endovascular abdominal aortic aneurysm repair presented with dyspnea on minimal exertion and typical angina pectoris. Echocardiography showed AVA 0.6 cm2, mean gradient of 41 mmHg, and left ventricular ejection fraction (LVEF) 0.35. There was severe three-vessel coronary disease with total occlusion of the right coronary. There were patent aortocoronary vein grafts to the circumflex and left anterior descending artery (LAD). Severe narrowing of the left main coronary into

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the proximal LAD branch was treated with stenting. The STS score was 6.3 %. Gated CT angiography showed the average aortic annulus diameter was 24.1 mm. Because of pelvic artery atherosclerosis, recent abdominal aortic aneurysm repair, and the position of the coronary bypass grafts, neither transfemoral nor transaortic approaches to TAVR were feasible, so transapical access was planned for TAVR. An IABP was inserted. Via a left anterior thoracotomy, the LV apex was identified and was prepared by dissection from dense adhesions and placement of pledgeted 3–0 monofilament pursestring sutures. The left heart was catheterized antegrade from the LV apex, and over an Amplatz Super Stiff wire (Boston Scientific) valvuloplasty and TAVR were performed with an Ascendra sheath (Edwards Lifesciences, Irvine, CA, USA), a 23-mm balloon, and a 26 mm Edwards SAPIEN valve. During valve deployment, the prosthesis ejected backward into the LV (Fig. 3A and Fig. 3B). Decision making included plans to 1) maintain the free valve in

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the LV on the wire and catheter, 2) reintroduce the tapered dilator of the Ascendra sheath and advance the sheath antegrade through the free valve, allowing for 3) implantation of a second valve. These were accomplished, and a second 26 mm Edwards SAPIEN valve was prepared and deployed satisfactorily. There was no regurgitation seen on transesophageal echocardiography (TEE). We then planned to remove the transapical catheters and wires to permit removal of the free prosthesis via the LV apex, but upon removal of the guidewire, the free valve was observed on fluoroscopy to rotate in the LV chamber such that within five heartbeats it had inverted and lodged in the LV outflow tract, entirely obstructing cardiac ejection. Femoral cardiopulmonary bypass was initiated, and ventricular fibrillation was induced. The catheter was removed from the LV apex, and a clamp introduced through this site. Using fluoroscopic guidance, the occlusive device was captured and removed through a small apical left ventriculotomy. The LV was repaired with two felt strips and 3–0 monofilament sutures. The patient was defibrillated into a paced rhythm, and he was then weaned from cardiopulmonary bypass. His course was further complicated by retroperitoneal bleeding requiring surgical left common iliac artery repair, and ureteral injury. A nephrostomy tube was placed. His ICU course was complicated by acute kidney and liver injury, pneumonia, pelvic deep vein thrombosis, stroke with hemiparesis and dysarthria, and atrial fibrillation. His hospital course was prolonged but he had no further heart failure. The LV ejection fraction was in the low normal range immediately following valve replacement. A gastrojejunostomy tube was placed for feeding, a caval filter was implanted, and systemic anticoagulation was given. He was transferred to a nursing care facility for rehabilitation. During his recovery period he developed urinary tract infection and pneumonia then septic shock, causing his demise five months after the valve procedure. DISCUSSION

Figure 3. (A) Transapical approach showing THV in LV in patient #3; the sheath has been advanced through the valve. (B) Transapical approach, deployment of second THV. The first has moved into LVOT.

The efficacy and feasibility of TAVR have been well documented in large multicenter clinical trials and registries.3–5 TAVR can be complicated by device malpositioning or migration after initial positioning (i.e., the valve moves up or down, leading to embolization into the aorta or left ventricle, respectively).6,7 The Valve Academic Research Consortium VARC-2 defined embolization by prosthesis movement ‘‘during or after deployment such that it loses contact with the aortic annulus.’’8 A recent meta-analysis found an incidence of valve embolization of 1.3 %.9 In an analysis of PARTNER trial data, the transfemoral approach was associated with more ventricular migration compared to the transapical approach.10 Reasons for embolization can often be identified,6 and causes for LV embolization may include 1) ‘‘watermelon seeding’’ of the balloon against a relatively small sinotubular space, 2) malpositioning during deployment, including because the radiographic projection angle did not delineate the level of the native annulus, 3) overcompensation for

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ventricular ejection during deployment, 4) movement of the catheter and wire relationship during balloon expansion, 5) dislodgement of an incompletely anchored device during valve-in-valve delivery. Aortic embolization of TAVR devices has been treated by endovascular techniques; deployment of ascending, arch, or descending aorta has been associated with favorable outcomes if management is prompt.11 In contrast, ventricular embolization requires surgery. From our single-center experience of 393 cases of Edwards TAVR and 97 CoreValve we identified three cases of ventricular embolization (incidence less than 1 %). From this experience we propose the following lessons. Maintaining the embolized valve on a guidewire is important, as a free Edwards-Sapien valve can quickly reverse and occlude LV outflow, necessitating extreme surgical maneuvers and resuscitation. When retrograde (transfemoral or direct aortic) TAVR is complicated by LV embolization, the deployment of a second valve in the correct position before removing the first one allows surgery to proceed after correction without the requirement of SAVR, and in some cases without aortic crossclamping. This sequence was less successful in a case of transapical TAVR with LV embolization. Another strategy described is to recapture the device onto its balloon in the LV, and to remove this system through the apex12 before delivering a second TAVR; our experience suggests that this might be a preferred approach for transapical TAVR with LV embolization. A third alternative for the transapical approach would be to deliver the second valve through the free first valve, then recapture the first valve on the balloon and remove it from the apex. Femoral cardiopulmonary bypass and induced ventricular fibrillation (or cardioplegia) allow removal through an apical ventriculotomy. While removal via the left atrium is possible, we speculate that the apical approach might be less likely to result in mitral valve injury.

2. Raiten JM, Gutsche JT, Horak J, Augoustides JG Critical care management of patients following transcatheter aortic valve replacement. F1000Research 2013;2:62. 3. Webb JG, Altwegg L, Boone RH, et al. Transcatheter aortic valve implantation: Impact on clinical and valverelated outcomes. Circulation 2009;119:3009–3016. 4. Zajarias A, Cribier AG Outcomes and safety of percutaneous aortic valve replacement. J Am College Cardiol 2009;53: 1829–1836. 5. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. New Engl J Med 2011;364:2187–2198. 6. Fassa AA, Himbert D, Vahanian A Mechanisms and management of TAVR-related complications. Nature Rev Cardiol 2013;10:685–695. 7. Tuzcu EM: Transcatheter aortic valve replacement malposition and embolization: Innovation brings solutions also new challenges. Catheterization Cardiovasc Interv 2008;72:579–580. 8. Kappetein AP, Head SJ, Genereux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: The Valve Academic Research Consortium-2 consensus document. J Am College Cardiol 2012;60:1438–1454. 9. Khatri PJ, Webb JG, Rodes-Cabau J, et al. Adverse effects associated with transcatheter aortic valve implantation: A meta-analysis of contemporary studies. Ann Internal Med 2013;158:35–46. 10. Makkar RR, Jilaihawi H, Chakravarty T, et al. Determinants and outcomes of acute transcatheter valve-in-valve therapy or embolization: A study of multiple valve implants in the U.S. PARTNER trial (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve). J Am College Cardiol 2013;62:418–430. 11. Tay EL, Gurvitch R, Wijeysinghe N, et al. Outcome of patients after transcatheter aortic valve embolization. JACCCardiovascular Interv 2011;4:228–234. 12. Astarci P, Desiron Q, Glineur D, et al. Transapical explantation of an embolized transcatheter valve. Interactive Cardiovasc Thorac Surg 2011;13:1–2.

REFERENCES

SUPPORTING INFORMATION

1. Webb JG, Chandavimol M, Thompson CR, et al. Percutaneous aortic valve implantation retrograde from the femoral artery. Circulation 2006;113:842–850.

Movie 1. Transesophageal echocardiographic image(s) illustrating severe aortic regurgitation and the transcatheter heart valve embolization into the left ventricle.

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Management of transcatheter aortic valve embolization into the left ventricle.

Embolization of transcatheter aortic valve replacement (TAVR) prostheses is a rare and serious procedural complication. While embolization into the ao...
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