Catheterization and Cardiovascular Interventions 00:00–00 (2014)

Case Report Elective Valve-in-Valve Implantation for Migration of a CoreValve in a Patient With Bicuspid Aortic Valve Stenosis Yutaka Tanaka,1* MD, PhD, Masashi Tanaka,2 MD, PhD, and Shigeru Saito,1 MD Transcatheter aortic valve implantation for bicuspid aortic valve stenosis (BAVS) is controversial, as its unfavorable anatomy may lead to device dislocation or malfunctioning. If device failure occurs, the bailout intervention can be more complex and technically challenging. We here report a unique case of late migration of a CoreValve (Medtronic, MN) implanted in a patient with BAVS, who was successfully treated with elective valve-in-valve implantation using the first valve as a firm scaffold after waiting for it to adhere at the migrated position. This new strategy may represent a useful salvage option for some patients with prosthesis migration. VC 2014 Wiley Periodicals, Inc. Key words: aortic valve disease; transcatheter valve implantation; structural heart disease intervention

INTRODUCTION

Several studies have reported that transcatheter aortic valve implantation (TAVI) is feasible for patients with bicuspid aortic valve stenosis (BAVS); however, there are still some technical issues to be solved [1–5]. The CoreValve (Medtronic, MN) implantation procedure for BAVS commonly includes a relatively high implantation, which is often used in an attempt to achieve good radial strength at annuli with massive paravalvular leakage [3,6]. The incidence of CoreValve dislocation is reported to be 3–12%, and an unfavorable anatomy, such as a curving of the ascending aorta, is considered as one of the anatomic risk factors for dislocation [6,7]. Importantly, bailout procedures can be more complex and cause critical secondary complications [8]. Here, we report a unique case of a late upward migration of a CoreValve (Medtronic) implanted in a patient with BAVS, who was successfully treated using the elective valve-in-valve (VIV) strategy after the first valve had been adhered and firmly fixed at the migrated position. Importantly, we followed this case for 1 year and confirmed the favorable clinical course.

(indexed aortic valve area, 0.27 cm2; peak velocity, 6.5 m/sec; mean pressure gradient, 96 mm Hg) and lung cancer, which was considered surgically curable. The patient had undergone multi-slice computed tomography (MSCT) for evaluation of aortic root anatomies (Table I). The root showed two unbalanced leaflets with asymmetric bulky calcifications and curving of the dilated ascending aorta (Fig. 1). Although a treatment plan was being devised, the patient experienced a subendocardial infarction and showed hemodynamic instability with pulmonary congestion, and consequently, she required catecholamine and 1

Department of Cardiology and Catheterization Laboratory, Shonan Kamakura General Hospital, Kamakura, Japan 2 Department of Cardiovascular Surgery, Shonan Kamakura General Hospital, Kamakura, Japan Conflict of interest: Nothing to report. *Correspondence to: Yutaka Tanaka, MD, PhD, Department of Cardiology and Catheterization Laboratory, Shonan Kamakura General Hospital, 1370-1 Okamoto, Kamakura, Kanagawa 247-8533, Japan. E-mail: [email protected] Received 18 September 2014; Revision accepted 14 December 2014

CASE REPORT

We here report the case of an 83-year-old woman (height, 147 cm; weight, 35 kg) with critical BAVS C 2014 Wiley Periodicals, Inc. V

DOI: 10.1002/ccd.25796 Published online 00 Month 2014 in Wiley Online Library (wileyonlinelibrary.com)

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Tanaka et al. TABLE I. Multi-Slice Computed Tomography Findings Parameter Major  minor aortic annulus diameter Aortic annulus perimeter Ascending aorta diameter Sinus of valsalva width Sinus of valsalva height Sinotubular junction width

Fig. 1. (A) Volume rendering showing the dilated ascending aorta. (B–F) Multi-planar reconstruction images showing the stenosed bicuspid aortic valve. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]

mechanical ventilation. Balloon valvuloplasty was performed as bridge therapy, using a 15-mm Z-Med II catheter (NuMED, NY), after which the patient could be weaned off the ventilator. Since the perioperative risks were regarded significant (logistic EuroSCORE, 29.06%; Society of Thoracic Surgeons Predicted Risk of Mortality score, 7.7%), TAVI was instead considered. Informed patient consent and approval from the institutional review board were obtained, and the procedure was performed under general anesthesia utilizing both fluoroscopic and transesophageal echocar-

Observed value 21  20 mm 65.6 (20.9  3.14) mm 38.7  38.1 mm 28.4–37.3 mm 21.8–26.7 mm 27.6–29.4 mm

diographic (TEE) guidance. Pre-implantation balloon valvuloplasty was performed with an 18-mm Z-Med II catheter. A third-generation 26-mm CoreValve prosthesis was implanted at a very high position through the right femoral artery and slightly dislocated just after the release (Fig. 2). Aortic root angiogram and TEE showed moderate paravalvular leakage. Additional procedures for moderate paravalvular leakage were considered, but were not performed, owing to the patient being hemodynamically stable and due to concerns that additional complications resulting from the complex procedures may have been critical for the patient at the moment. The in-hospital course was uneventful with careful follow-up, and the patient was discharged 6 days after the procedure with improvement of the heart failure. However, 19 days after discharge, she was readmitted for acute dyspnea, and TEE showed severe aortic regurgitation of undetermined origin. MSCT finally revealed that the implanted CoreValve had migrated into the ascending aorta (Fig. 3). A multidisciplinary meeting was held, and a re-attempt at TAVI was decided rather than bailout surgery. The second TAVI was performed 57 days after the first procedure. We initially attempted pulling up the CoreValve above the sinotubular junction by using the Amplatz GooseNeck Microsnare Kit (35 mm; ev3, Plymouth, MN). However, the CoreValve was strongly attached to the calcified aortic valve and could not be moved (Fig. 4A). Subsequently, we instead performed VIV implantation. A second 26-mm CoreValve was successfully implanted at a lower position through the first one with post-dilatation, using a 22-mm Tyshak balloon (NuMED, NY) (Fig. 4B and C). After implantation of the second valve, no aortic regurgitation, including paravalvular and transvalvular leakage, was noted (Fig. 4D and E). No procedural complications, except a new ventricular branch block, were noted, and the patient was discharged 6 days after the procedure with significant improvement. CT conducted 2 months later showed good fixation of both prostheses at the appropriate positions (Fig. 5). At the latest follow-up, 1 year after the VIV procedure, the patient was in quite good condition without any symptom or cardiovascular event. Transthoracic

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

Elective VIV for CoreValve Migration

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Fig. 2. (A, B) Fluoroscopic images captured during and after CoreValve implantation. Catheterization hemodynamics (C) before and (D) after implantation.

echocardiography confirmed excellent function of the prosthesis (indexed aortic valve area, 1.80 cm2; peak velocity, 2.4 m/sec; mean pressure gradient, 11 mm Hg), with the absence of residual regurgitation. DISCUSSION

This clinical course of the present patient provided two important clinical suggestions regarding TAVI for BAVS. First, BAVS with a curving of dilated ascending aorta is one of the unfavorable anatomies for CoreValve implantation, and can lead to dislocation and/or late migration. For patients with such an unfavorable anatomy, careful follow-up for at least a few weeks after implantation is necessary. Second, when late prosthesis migration occurs, elective VIV implantation upon waiting for the fixation of the migrated prosthesis is safe, and should be included among the possible salvage strategies. In this case, the prosthesis was accidentally implanted in a too high position, resulting in dislocation just after the release due to asymmetric bulky calcifications and curving of the ascending aorta. We believe that curving of the dilated ascending aorta just above the sinotubular junction prevented permanent anchoring at the ascending aorta and continuously pushed out the outflow portion of the first prosthesis, causing it to migrate late after implantation. BAVS is often accompanied with unbalanced leaflets with asymmetric bulky calcifications and a dilated ascending aorta, which may represent potential risk factors for CoreValve dislocation and migration [7,9,10]. Although predictive factors for late migration have not been clarified, a too high implantation position might also be associated with the late migration. In hindsight,

Fig. 3. Aortography and multi-planar reconstruction images showing bioprosthesis migration.

additional procedures could potentially have been performed at the same time. However, on the other hand, sequential complex procedures might have caused other complications, which could have been critical for the patient [7,8]. If perfect CoreValve anchoring cannot be achieved and the continuous distortion is excessive, careful echocardiographic follow-up is required. Once prosthesis failure is suspected, MSCT, which can precisely detect the anatomical structure and prosthesis position, is one of the best tools for the diagnosis and the evaluation of the therapeutic strategy.

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

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Tanaka et al.

Fig. 4. (A–C) Fluoroscopic images captured during VIV implantation. Catheterization hemodynamics (D) before and (E) after VIV implantation.

There are several possible managements for CoreValve dislocation. For too deep implantations, implantation of a second valve in the first one, but in a higher position, or adjustment of the device position using a snare, can be attempted [11,12]. For the upward migration, on the other hand, retraction of the prosthesis above the sinotubular junction using a snare and implantation of a second valve in the correct annular position can be performed [6]. However, prosthesis retraction is technically challenging and curving of the ascending aorta may impede retraction of the prosthesis. Additionally, there might be a risk of aortic dissection or perforation, especially in BAVS patients, owing to a genetic defect in the ascending aorta [8,9]. In contrast, elective second valve implantation, i.e. elective VIV after the firm fixation of the migrated prosthesis, appears safe and effective. We were able to wait for 2 months for the first prosthesis to be adhered without any critical events occurring, although there are currently no data on the appropriate period for

prosthesis adhesion. In the second TAVI procedure, we confirmed that the first prosthesis was firmly fixed at the migrated position, and subsequently performed VIV implantation using the first valve as a firm scaffold. By fixing the second valve within the first one, the risk of additional migration could be mitigated. Importantly, we were able to confirm a favorable longterm outcome 1 year later, indicating that this strategy may be useful for prosthesis migration in a subset of patients.

CONCLUSION

BAVS is often accompanied with curving of the dilated ascending aorta, which may be a risk factor for CoreValve migration, even weeks after the procedure. Elective VIV implantation after waiting for the fixation of the migrated prosthesis appears feasible, safe, and effective; and this new strategy should be included among the possible salvage options.

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

Elective VIV for CoreValve Migration

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Fig. 5. (A–C) Computed tomography images of the second CoreValve inside the first CoreValve taken 2 months after the valve-in-valve procedure. The purple-colored valve is the migrated CoreValve frame and the pink-colored valve is the second valve. Yellow indicates valve calcification. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]

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ACKNOWLEDGMENTS

The authors thank J.C. Laborde, MD (St George’s Hospital) and H. Danenberg, MD (Hadassah-Hebrew University Medical Center) for their helpful advice on the procedure. Also we appreciate K. Iwasaki, Ph.D (Center for Advanced Biomedical Sciences/TWIns, Waseda University) and K. Asato for the generous support and encouragement.

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Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

Elective valve-in-valve implantation for migration of a Corevalve in a patient with bicuspid aortic valve stenosis.

Transcatheter aortic valve implantation for bicuspid aortic valve stenosis (BAVS) is controversial, as its unfavorable anatomy may lead to device disl...
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