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Ann Thorac Surg 2009;87:1943-1946. doi:10.1016/j.athoracsur.2008.11.034
© 2009 The Society of Thoracic Surgeons
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Case Reports

Transapical Transcatheter Treatment of a Stenosed Aortic Valve Bioprosthesis Using the Edwards SAPIEN Transcatheter Heart Valve

Kaj-Erik Klaaborg, MDa, Henrik Egeblad, MDb, Carl-Johan Jakobsen, MDc, Kim Terp, MDa, Christian Lindskov, MDc, Henning Rud Andersen, MDb, Leif Thuesen, MDb,*

a Department of Thoracic and Cardiovascular Surgery, Aarhus University Hospital, Skejby, Denmark
b Department of Cardiology, Aarhus University Hospital, Skejby, Denmark
c Department of Anesthesiology, Aarhus University Hospital, Skejby, Denmark

Accepted for publication November 10, 2008.

* Address correspondence to Dr Thuesen, Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus N, 8200, Denmark (Email: leif.thuesen{at}ki.au.dk).


   Abstract
Top
 Abstract
Introduction
 Comment
 References
 
Transcatheter transapical or transfemoral aortic valve replacement has emerged as an alternative therapy of severe, symptomatic valvular aortic stenosis in surgically nonamenable patients. We report a transapical treatment of a severely stenosed 21-mm aortic Mitroflow valve bioprosthesis (Sorin Group, Vancouver, British Columbia, Canada) in an 82-year-old woman using a 23-mm Edwards SAPIEN Transcatheter Heart Valve (Edwards Lifesciences, Irvine, CA).


   Introduction
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 Abstract
 Introduction
Comment
 References
 
Surgical replacement of degenerated bioprosthetic valves is associated with increased perioperative risk [1, 2]. These procedures are reoperations often in elderly patients with considerable comorbidities. Transcatheter transapical or transfemoral aortic valve replacement has emerged as an alternative therapy of severe, symptomatic valvular aortic stenosis in surgically nonamenable patients [3–8]. This novel technique for the treatment of degenerated valvular bioprostheses has been described in a few patients [9, 10]. At present, the treatment of a 23-mm Mitroflow valve (Sorin Group, Vancouver, British Columbia, Canada) using the CoreValve System (CoreValve, Irvine, CA) has been published [10]. Also, a degenerated 21-mm Perimount prosthesis (Edwards Lifesciences, Irvine, CA) was successfully treated by transapical implantation of a cuffed transcatheter valve (Edwards Lifesciences, Irvine, CA) [11]. We report transapical treatment of a stenosed 21 mm Mitroflow aortic valve prosthesis using the Edwards SAPIEN Transcatheter Heart Valve (THV; Edwards Lifesciences).

An 82-year-old woman underwent aortic valve replacement (21-mm Mitroflow) in 2002 because of severe aortic valve stenosis. Two years later, she was treated with a DDD pacemaker because of sick sinus syndrome. The patient also had intermittent claudication because of stenoses of the iliac and femoral arteries. Since 2007, the patient experienced a rapidly deteriorating condition with shortness of breath, chest pain, and overt heart failure.

Significant stenoses of the right and the circumflex coronary arteries were treated with drug-eluting stents, but with no clinical improvement. The aortic bioprosthesis was found to be severely stenosed, with a valve area of 0.4 cm2 and a peak gradient of 100 mm Hg according to transthoracic (TTE) and transesophageal echocardiography (TEE). Left ventricular function was normal. The systolic pulmonary pressure was 65 mm Hg according to TTE. Renal function was moderately impaired (serum creatinine, 140 µmol/L).

The patient was considered for conventional aortic valve replacement, but with a logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) of 53%, the perioperative risk was considered unacceptably high. Instead, we suggested dilatation of the stenotic prosthesis and transapical insertion of an Edwards SAPIEN THV. We were aware—and the patient was informed—that this would be an experimental and nonrecommended use of the device. In advance, we had compared a Mitroflow 21-mm valve with a 23-mm Edwards SAPIEN THV, and found it possible to cover the Mitroflow cusps if the SAPIEN THV was implanted about 3 mm below the ring of the Mitroflow valve. We anticipated that this position would secure stability and optimal functional result of the stent valve implantation.

The procedure was performed with extensive hemodynamic monitoring under general anesthesia but without artificial cardiopulmonary support. Through a 5-cm-long thoracotomy in the fifth left intercostal space and after insertion of myocardial pacing electrodes, the left ventricle was punctured at the apex. A soft, 0.35-inch J-tip wire was inserted through the stenosed aortic valve prosthesis. A right coronary catheter was used to change to an Amplatz Extra Stiff 0.35-inch wire (Cook Medical, Bloomington, IN). A 14F introducer sheath was inserted over the guidewire, with the tip of the sheath positioned in the middle of the left ventricle.

During rapid cardiac pacing (220 beats/min), the aortic valve bioprosthesis was dilated with a 5-cm-long, 23-mm dilatation balloon catheter (Fig 1). We changed to a 26F sheath, and the 23-mm Edwards SAPIEN THV was implanted during rapid pacing (220 beats/min) within the degenerated Mitroflow valve. Fluoroscopy was used to position the inflow part of the stent valve just below the ring of the Mitroflow valve as planned (Figs 2 and 3). Go


Figure 1
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  		Fig 1. Predilatation with a 23-mm balloon. At maximal dilatation, a waist was seen at the radio opaque ring of the Mitroflow valve.

 

Figure 2
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  		Fig 2. Positioning of the unexpanded stent valve. The stent valve delivery system was well aligned.

 

Figure 3
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  		Fig 3. Edwards SAPIEN Transcatheter Heart Valve deployed within the Mitroflow valve. Note the waist of the stent at the level of the Mitroflow valve ring.

 
Hemodynamically, the patient recovered rapidly after deflation of the stent valve balloon. Intraoperative TEE and an aortography showed a well functioning stent valve with minimal central leakage. The patient was extubated immediately after the procedure and had a fast and uneventful recovery. She was discharged from the hospital 2 weeks after the procedure in markedly improved condition. TTE and TEE before discharge showed normal left ventricular function and a mild central aortic valve regurgitation with a vena contracta of 3 mm (Fig 4). However, the peak Doppler pressure gradient over the stent valve was 40 mm Hg; after the primary valve replacement in 2002, the peak Doppler pressure gradient was 20 mm Hg across the Mitroflow valve. The calculated valve area was 1.0 cm2 according to TTE, and this was confirmed by planimetry of TEE images (Fig 4).


Figure 4
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  		Fig 4. Transesophageal echocardiography. (A and B) The 23-mm Edwards SAPIEN valve is closed and open in three-dimensional echocardiograms. (C and D) The valve is closed and open by two-dimensional echocardiography. (C) The yellow vena contracta of the valve insufficiency flow is shown. (D) The opening area (O) of the Edwards SAPIEN valve was measured to 1 cm2 by planimetry.

 

   Comment
Top
 Abstract
 Introduction
 Comment
References
 
We report that (1) a degenerated and severely stenotic Mitroflow valve prosthesis can be treated successfully by means of the Edwards SAPIEN THV, (2) the implanted 23-mm stent valve had an acceptable function, although it was implanted in a 21-mm valve prosthesis and despite some underexpansion of the in-flow part of the stent valve (Fig 3), and (3) after implantation, the valve area and peak gradient were less favorable than after Edwards SAPIEN THV valve treatment of native aortic valve stenoses.

Before implanting the Edwards SAPIEN THV, we discussed several potential problems:

1 Where to position the valve?
2 Could the stent valve be expanded properly?
3 Would the flow characteristics of the stent valve be impaired by insufficient expansion?
4 Would there be a leakage between the Mitroflow valve and the Edwards SAPIEN THV?

We decided to position the inferior edge of the stent valve immediately below the radiopaque ring of the Mitroflow valve. We anticipated that a position too low might result in insufficient dilatation and opening of the agglutinated leaflets of the Mitroflow valve. Conversely, a position just above the Mitroflow valve ring might be too high and result in obstruction of the coronary arteries or peripheral dislodgement of the Edwards SAPIEN THV. The apical approach allowed an excellent alignment between the Edwards SAPIEN THV Ascendra delivery system and the aortic root. The choice of position was apparently a correct decision, because the implanted Edwards SAPIEN THV remained in a stable position and covered the degenerated leaflets of the Mitroflow valve.

The concern of underexpansion was handled using a 23-mm dilatation balloon for predilatation. During the balloon predilatation, we suspected and noticed that the Mitroflow valve could only be partially dilated. We found, however, that the waist of the dilatation balloon was sufficiently small to proceed with the procedure (Fig 1). During and after the implantation of the Edwards SAPIEN THV, a moderate waist of the stent was observed. A smaller waist may be seen after Edwards SAPIEN THV treatment of genuine aortic valve stenoses. The moderate waist of the stent valve did not result in failure of the valve leaflet function. However, the waist probably resulted in the Doppler pressure gradient of 40 mm Hg across the Edwards SAPIEN THV and a valve area of only 1 cm2, features less favorable than after implantation of a stent valve in a native aortic valve stenosis.

At present, the Edwards SAPIEN THV Valve is commercially available in a 23- and a 26-mm version. When used in stenotic genuine aortic valves, the stent valve is usually oversized by 2 to 3 mm to secure stability and minimize paravalvular leakage. It is possible that oversizing should not be done in the valve-in-valve situation, and that a 21-mm device (not commercially available) might have performed better in the present case. Nevertheless, the treatment resulted in marked hemodynamic and clinical improvement compared with the pretreatment situation

As in previous reports, the present case may give rise to some optimism concerning stent valve treatment of degenerated bioprosthetic heart valves. However, these procedures are still highly experimental, and extended follow-up are needed to evaluate the potential of the treatment.


   References
Top
 Abstract
 Introduction
 Comment
 References
 

  1. Jamieson WRE, Rosado LJ, Munro AI, et al. Carpentier-Edwards standard porcine bioprosthesis: Primary tissue failure (structural valve deterioration) by age groups Ann Thorac Surg 1988;46:155-162.[Abstract/Free Full Text]
  2. Bonow RO, Carabello BA, Kanu C, et al. 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 Circulation 2006;114:e84-e231.[Free Full Text]
  3. Andersen HR, Knudsen LL, Hasenkam JM. Transluminal implantation of artificial heart valves. Description of a new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs. Eur Heart J 1992;13:704-708.[Abstract/Free Full Text]
  4. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis Circulation 2002;106:3006-3008.[Abstract/Free Full Text]
  5. Webb JG, Pasupati S, Humphries K, et al. Percutaneous transarterial aortic valve replacement in selected high-risk patients with aortic stenosis Circulation 2007;116:755-763.[Abstract/Free Full Text]
  6. Grube E, Schuler G, Buellesfeld L, et al. Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome J Am Coll Cardiol 2007;50:69-76.[Medline]
  7. Ye J, Cheung A, Lichtenstein SV, et al. Transapical aortic valve implantation in humans J Thorac Cardiovasc Surg 2006;131:1194-1196.[Free Full Text]
  8. Walther T, Falk V, Borger MA, et al. Minimally invasive transapical beating heart aortic valve implantation–proof of concept Eur J Cardiothorac Surg 2007;31:9-15.[Abstract/Free Full Text]
  9. Webb JG. Transcatheter valve in valve implants for failed prosthetic valves Catheter Cardiovasc Interv 2007;70:765-766.[Medline]
  10. Wenaweser P, Buellesfeld L, Gerckens U, Grube E. Percutaneous aortic valve replacement for severe aortic regurgitation in degenerated bioprosthesis: the first valve in valve procedure using the Corevalve Revalving system Catheter Cardiovasc Interv 2007;70:760-764.[Medline]
  11. Walther T, Kempfert J, Borger MA, et al. Human minimally invasive off-pump valve-in-a-valve implantation Ann Thorac Surg 2008;85:1072-1073.[Abstract/Free Full Text]



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