Catheterization and Cardiovascular Interventions 85:916–919 (2015)

Transapical JenaValve in a Patient with Mechanical Mitral Valve Prosthesis Katie E. O’ Sullivan,1 MB BCh, BAO, MRCSI, Ivan Casserly,2 MB BCh, and John Hurley,1* MB BCh, FRCSI We report the first case of transcatheter aortic valve replacement implantation using JenaValveTM in a patient with mechanical mitral valve prosthesis. We believe that the design features of this valve may be particularly suited for use in this setting. VC 2014 Wiley Periodicals, Inc.

Key words: aortic disease; mitral valve disease; transcatheter valve implantation

INTRODUCTION

Transcatheter aortic valve replacement (TAVR) is well-established as a treatment option for patients with severe symptomatic aortic stenosis (AS), who are at high risk for surgical aortic valve replacement [1]. Patients with prior mechanical mitral valve replacement have been excluded from randomized controlled trials of TAVR, due to concerns over possible interference between the mitral prostheses and the TAVR valve. As experience with TAVR technology has evolved, a number of patients with mechanical mitral valves have been treated with TAVR, although the scenario continues to present a technical challenge. The JenaValveTM is a next generation transapical TAVR valve consisting of a porcine root valve mounted on a low-profile nitinol stent. The valve is fully retrievable and repositionable. Although a limited number of TAVR implantations in the presence of mechanical mitral valve prostheses have been reported, there are no previously published cases utilizing the JenaValveTM [2,3]. We report our experience with one such case and discuss the features of the JenaValveTM that we believe offer some advantage for use in this particular scenario. CASE

A 60-year-old woman with severe AS was referred to our high-risk aortic valve clinic for consideration for TAVR. The patient had an extensive medical history including pulmonary hypertension, chronic obstructive pulmonary disease, an 80-pack-year smoking history, previous stroke, chronic atrial fibrillation, type 2 diabetes mellitus, and a history of mechanical mitral valve replacement using a Medtronic Hall disc valve combined with coronary artery bypass grafting 10 years previously. Her functional status was poor, with shortC 2014 Wiley Periodicals, Inc. V

ness of breath on minimal exertion (NYHA Class III). She had been repeatedly admitted with right-sided heart failure in the months preceding referral. Her STS-PROM and EuroSCORE 2 were 6.55 and 6.48%, respectively. In an attempt to confirm that AS was the cause for these repeated presentations and assess for potential clinical improvement with TAVR, a balloon valvuloplasty was performed. Good symptomatic relief was obtained following valvuloplasty, which supported the clinical decision to proceed with TAVR. Contrast computed tomography showed the presence of severely calcified and tortuous iliofemoral arteries bilaterally with a maximum diameter of 4 mm, ruling out the option of TAVR using femoral access. Therefore, a transapical approach was planned. Given concerns surrounding the potential interference with the existing mechanical valve prosthesis, a JenaValveTM was selected as it was felt that this valve design minimized the risk of interaction between the aortic prosthesis and the mechanical mitral valve [4]. A Heart Team including cardiothoracic surgeons and interventional cardiologists performed the procedure in a hybrid catheterization laboratory under general 1

Department of Cardiothoracic Surgery, Mater Misericordiae University Hospital, Dublin, 7, Ireland 2 Department of Cardiology, Mater Private Hospital, Dublin, Ireland Conflict of interest: Nothing to report. *Correspondence to: John Hurley, Department of Cardiothoracic Surgery, Mater Misericordiae University Hospital, Dublin 7, Ireland. E-mail: [email protected] Received 23 September 2013; Revision accepted 25 January 2014 DOI: 10.1002/ccd.25415 Published online 29 January 2014 in Wiley Online Library (wileyonlinelibrary.com)

Mechanical Mitral Valve Prosthesis

Fig. 1. Preprocedural computed tomography image illustrating the relationship between the aortic annulus and the mechanical mitral prosthesis. Measured distance between the two was 4.8 mm. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]

anesthesia with transesophageal echo guidance. On the basis of an aortic annular measurement of 23.9 mm, a 25 mm JenaValveTM had been selected and preprocedural imaging performed. Measured distance between the aortic annulus and mechanical mitral prosthesis was 4.8 mm (Fig. 1), and distances between the aortic annulus and the right and left coronary ostia were 16.2 and 8.1 mm, respectively. A left anterior minithoracotomy was performed overlying the sixth intercostal space. The pericardium was dissected and opened at the apex of the heart. Two plegeted purse strings were placed in the apex and the left ventricular cavity was accessed using the Seldinger technique first with a soft guidewire followed by a stiff guidewire which was advanced into the descending aorta. Balloon valvuloplasty was performed under rapid ventricular pacing. After removal of the balloon, the sheathless 32-Fr delivery catheter was advanced through the apex to the ascending thoracic aorta. The positioning feelers were released and oriented with respect to the coronary sinuses. The delivery system was then pulled back to position the feelers deep in the coronary sinuses (Fig. 2) the lower part of the stent was released, clipping the native leaflets to the valve while the remaining upper portion of the valve was unfolded (Fig. 3). Complete valve deployment was performed under fluoroscopic control under beating heart conditions without rapid pacing. Transesophageal echo (TEE) was used after the valve was deployed to assess satisfactory positioning of the JenaValveTM, transvalvular gradients, interference with the mechanical prosthesis, paravalvular, and central regurgitation. TEE was not used during the case. The post procedural pressure gradient across the aortic valve was 12 mm Hg, and there was no evidence

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Fig. 2. Jena ValveTM partially deployed with “feelers” situated in the aortic sinuses.

Fig. 3. Jena ValveTM fully deployed.

of paravalvular leakage (Fig. 4). Standard surgical closure of the left ventricular apex was performed. The patient was extubated the following day and recommenced on intravenous heparin 24 hr following the procedure. A left pleural effusion which required placement of a pleural drain complicated recovery. She was discharged on warfarin therapy on the 12th-post operative day. DISCUSSION

We report the first successful TAVR implantation of a JenaValveTM in a patient with a mechanical mitral prosthesis. The main concern with TAVR in the

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

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O’ Sullivan et al. TABLE I. Summary of Published Cases of TAVI Implantation in the Presence of a Mechanical Mitral Valve Authors Transapical approach Rodes-Cabau et al. [2] Scherner et al. [5] Chao et al. [6] Drews et al. [7] Beller et al. [8] Transfemoral approach Bruschi et al. [3] Kahlert et al. [9] Beller et al. [8] Garcia et al. [10] Bruschi et al. [11] Transaortic approach Bruschi et al. [11]

Fig. 4. Post procedural transesophageal echocardiography demonstrating the absence of paravalvular leakage after valve implantation. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]

presence of a mechanical mitral valve prosthesis is the potential for interaction between the two valves with interference with the function of the mitral valve. A secondary concern is the potential for an increased risk of paravalvular regurgitation due to asymmetrical stent dilation in the left ventricular outflow tract (LVOT) below the annulus. Despite these concerns, since 2008 [2], approximately 25 cases of patients with mechanical mitral prostheses treated with TAVR have been reported (Table I). Of the 25 cases reported, the TAVR valve was successfully deployed in all patients. There was transient dysfunction of a Bjork–Shiley tilting valve due to contact with the delivery system during a transapical procedure requiring temporary withdrawal of the delivery system [7]. This complication would appear to be less likely to occur using a retrograde approach [3,9–11]. However, it does seems likely that further unpublished cases have also been performed, and that lower rates of technical success and higher rates of complications may have gone unreported due to publication bias. The JenaValveTM transapical system received CEmark approval in Europe in 2011 and prospective data collection is ongoing [12]. The system consists of a full porcine root valve mounted on a low-profile selfexpanding nitinol stent (Fig. 5). Technical features include active clip fixation of the native aortic valve leaflets thereby reducing radial forces on cardiac and aortic structures. Treede et al. report good initial experience with use of the valve in 60 patients with a success rate of 89.6% [13]. Overall, 30-day mortality of 7.6% reported compares favorably to the recently published series of transapical TAVR reported by

Publication date

Valve

Patient number

2008 2009 2010 2010 2011

ES ES ES ES ES

1 1 1 2 4

2009 2009 2011 2011 2013

MCV MCV ES SXT MCV

4 1 1 3 5

2013

MCV

2

MCV, Medtronic Corevalve; ES, Edward Sapien; SXT, Sapien XT * two patients via direct aortic approach.

Fig. 5. The JenaValveTM consists of a full porcine root valve mounted on a low-profile self-expanding nitinol stent. Arrow demonstrates the “feelers.” [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]

D’Onofrio et al. who describe a 30-day mortality rate of 9.9% [14]. The design of the JenaValveTM offers some potential advantage in treating patients with a mechanical mitral prosthesis. If the valve is deployed correctly, the feelers in the aortic sinuses prevent the lower margin of the valve stent reaching more than 2 mm into the LVOT below the plane of the aortic annulus (Fig. 6). Given that the typical distance between the aortic annulus and a mechanical mitral prosthesis is 10 6 1 mm [8], the descent of the JenaValveTM into the LVOT of  2 mm offers what appears to be a reasonable safety margin in preventing an interaction between the two protheses. Additionally, the minimal length of valve stent in the LVOT reduces the risk of asymmetric stent expansion due to the presence of the rigid

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

Mechanical Mitral Valve Prosthesis

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REFERENCES 1. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363(17):1597–1607. 2. Rodes-Cabau J, Dumont E, Miro S, Doyle D, De Larochelliere R, Clavel MA, et al. Apical aortic valve implantation in a patient with a mechanical valve prosthesis in mitral position. Circ Cardiovasc Interv 2008;1(3):233. 3. Bruschi G, De Marco F, Oreglia J, Colombo P, Fratto P, Lullo F, et al. Percutaneous implantation of CoreValve aortic prostheses in patients with a mechanical mitral valve. Ann Thorac Surg 2009;88(5):e50–e52. 4. Wendt D, Thielmann M, Price V, Kahlert P, Kuhl H, Kamler M, et al. Coronary ostium topography: An implication for transcatheter aortic valve implantation? Minim Invasive Ther Allied Technol. 2013;22(2):65–72. 5. Scherner M, Strauch J, Haldenwang P, Baer F, Wahlers T. Successful transapical aortic valve replacement in a patient with a previous mechanical mitral valve replacement. Ann Thorac Surg 2009;88(5):1662–1663. 6. Chao VT, Chiam PT, Tan YS, Transcatheter aortic valve implantation with preexisting mechanical mitral prosthesis—Use of CT angiography. J Invasive Cardiol 2010;22(7):339–340. 7. Drews T, Pasic M, Buz S, Unbehaun A, Dreysse S, Kukucka M, et al. Transapical aortic valve implantation after previous mitral valve surgery. J Thorac Cardiovasc Surg 2011;142(1):84–88. Fig. 6. Illustration of the JenaValveTM fully deployed with the feelers sitting in the coronary sinuses. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]

mitral prosthesis. This may potentially reduce the risk of paravalvular leak in this circumstance, and may also have a beneficial impact on valve leaflet longevity. Our experience with the JenaValve in this setting demonstrated a number of advantages; however, further data are required to validate the arguments we have made. Until further experience with the JenaValve is attained, our hypotheses regarding the particular suitability of the JenaValve in the setting of mechanical valve prostheses will remain as such. CONCLUSIONS

To our knowledge, this is the first reported case of TAVR implantation using JenaValveTM in a patient with mechanical mitral valve prosthesis. Although further data are required to support its usefulness in this setting, we believe that the design features of this valve may be particularly suited.

8. Beller CJ, Bekeredjian R, Krumsdorf U, Leipold R, Katus HA, Karck M, et al. Transcatheter aortic valve implantation after previous mechanical mitral valve replacement: Expanding indications? Heart Surg Forum. 2011;14(3):E166–E170. 9. Kahlert P, Eggebrecht H, Thielmann M, Wendt D, Jakob H, Sack S, et al. Transfemoral aortic valve implantation in a patient with prior mechanical mitral valve replacement. Herz 2009;34(8):645–647. 10. Garcia E, Albarran A, Heredia-Mantrana J, Guerrero-Pinedo F, Rodriguez J, Hernandez-Antolin R, et al. Transcatheter aortic valve implantation in patients with a mechanical mitral valve. Rev Esp Cardiol 2011;64(11):1052–1055. 11. Bruschi G, De Marco F, Barosi A, Colombo P, Botta L, Nonini S, et al. Self-expandable transcatheter aortic valve implantation for aortic stenosis after mitral valve surgery. Interact Cardiovasc Thorac Surg 2013;17(1):90–95. 12. Treede H, Rastan A, Ferrari M, Ensminger S, Figulla HR, Mohr FW. JenaValve. EuroIntervention 2012;8 Suppl Q:Q88–Q93. 13. Treede H, Mohr FW, Baldus S, Rastan A, Ensminger S, Arnold M, et al. Transapical transcatheter aortic valve implantation using the JenaValve system: Acute and 30-day results of the multicentre CE-mark study. Eur J Cardiothorac Surg 2012;41(6):e131–e138. 14. D’Onofrio A, Salizzoni S, Agrifoglio M, Cota L, Luzi G, Tartara PM, et al. Medium term outcomes of transapical aortic valve implantation: Results from the italian registry of transapical aortic valve implantation. Ann Thorac Surg 2013;96(3): 830–836.

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

Transapical JenaValve in a patient with mechanical mitral valve prosthesis.

We report the first case of transcatheter aortic valve replacement implantation using JenaValve™ in a patient with mechanical mitral valve prosthesis...
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