Ann Thorac Surg 2007;83:284-287
© 2007 The Society of Thoracic Surgeons
Case Reports
Implantation of the CoreValve Percutaneous Aortic Valve
Yoan Lamarche, MDa,
Raymond Cartier, MDa,
André Y. Denault, MDb,
Arsène Basmadjian, MDc,
Colin Berry, MD, PhDa,
Jean-Claude Laborde, MDd,
Raoul Bonan, MDc,*
a Department of Surgery, Montréal Heart Institute and "Université de Montréal," Montréal, Québec, Canada
b Department of Anesthesiology, Montréal Heart Institute and "Université de Montréal," Montréal, Québec, Canada
c Department of Cardiology, Montréal Heart Institute and "Université de Montréal," Montréal, Québec, Canada
d Department of Cardiology, Clinique Pasteur, Toulouse, France
Accepted for publication May 31, 2006.
* Address correspondence to Dr Bonan, Department of Medicine, Montréal Heart Institute, 5000 Belanger St, Montréal, Québec H1T1C8, Canada (Email: raoul.bonan{at}mmic.net).
| Drs Bonan and Laborde disclose that they have a financial relationship with CoreValve, Inc.
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Abstract
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Surgical aortic valve replacement is the only recommended treatment for significant aortic valve stenosis. Percutaneous aortic valve replacement appears to be a novel option for high-risk patients. We report the implantation of the ReValving system (CoreValve, Paris, France) in a 64-year-old woman who was refused aortic valve replacement surgery for critical aortic stenosis and left ventricular dysfunction because of severe pulmonary fibrosis. After anesthesia, the patient was put on femorofemoral cardiopulmonary bypass, and underwent a balloon valvuloplasty with subsequent retrograde aortic valve replacement by the ReValving system. Transesophageal echocardiographic monitoring of the patient’s hemodynamics showed immediate improvements of the valvular area and left ventricular ejection fraction and only traces of paravalvular leaks. The patient was easily weaned from ventilation and resumed activity soon after the surgery. A multidisciplinary approach is presently necessary to offer a reliable and safe procedure.
Aortic surgery is associated with a low risk in most patients [1]. Extreme-risk candidates who are denied aortic valve replacement despite critical aortic stenosis have a poor prognosis [2]. Percutaneous valve replacement therapy is a new alternative for high-risk surgical patients [3]. Percutaneous aortic valve replacement using a balloon-expandable bioprosthesis was described in 2002 in a patient [4] for compassionate use. We report a patient who received the CoreValve ReValving aortic prosthesis (CoreValve, Paris, France), a self-expandable bioprosthesis, with special attention to the multidisciplinary medical team approach.
The patient was a 64-year-old woman with severe idiopathic pulmonary fibrosis with 0.62 liters forced expiratory volume in 1 second (FEV1) and 0.65 liters functional capacity. She required permanent oxygen supplementation. She also had a significant aortic stenosis (0.61 cm2), with a depressed left ventricular function (left ventricular ejection fraction [LVEF] of 0.20) and pulmonary hypertension. She had New York Heart Association class IV dyspnea. Her Parsonnet score was 35 (predicted operative mortality, 10% to 25%). Heart surgery was declined by two university multidisciplinary teams, and a palliative balloon aortic valvuloplasty was performed first in May 2005 as a bridge to a future percutaneous intervention.
After approval for compassionate use by the Montreal Heart Institute Ethics Committee and the accessibility of the device under special access by the federal health agency, the patient was offered a percutaneous aortic valve replacement in December 2005. Complete information of the risks and benefits was described to the patient and accepted.
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The Valve
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The CoreValve Aortic Valve Prosthesis is a self-expanding heart valve frame designed for the replacement of the native or already-in-place bioprosthetic aortic heart valve. The prosthesis consists of a frame and a biologic valve [3]. The CoreValve consists of a three-part self-expanding frame made from laser cut nitinol tubing (Fig 1). The upper part (aortic level) of the frame increases the prosthesis fixation to the aorta wall and axes the system parallel to the blood flow. The middle part (commissural level) carries the valve (porcine pericardium). The convex shape of this level is opposed to the concavity of the coronary sinus to preserve natural hemodynamic flow. The lower conical part covered by pericardium (annulus level) firmly anchors the prosthesis to the aortic annulus, preventing any migration and paravalvular leaks by creating a high radial force.
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Fig 1. CoreValve ReValving Prosthesis. Upper part (aortic level), middle part (commissural level), lower part (annulus level).
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Because of the self-expanding nature of the frame with a radial force of the order of >2.5 kg force at the annulus, it can adapt to noncircular local anatomies and does not recoil after expansion.
The CoreValve prosthesis is preloaded and compressed in a 21-French outer diameter catheter. The prosthesis is then delivered from the right femoral artery in a retrograde fashion under femorofemoral cardiopulmonary bypass (CPB) which prevents prosthesis movement during deployment.
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Anesthesiology Considerations
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To allow transesophageal echocardiographic monitoring, the most prudent anesthetic technique is to induce anesthesia in an awake patient with topical anesthesia, with continuous control of systemic arterial pressure. This allows anesthesia induction in a smoother fashion and prevents the acute effect of anesthesia induction and positive pressure ventilation. Regional brain oxygenation was monitored throughout the procedure using the INVOS 4100 (Somanetics Corporation, Troy, MI).
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Surgical and Interventional Considerations
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The left and right femoral arteries and left femoral vein were exposed for prosthesis insertion and CPB. Beforehand, a 4F pigtail for contrast injection was positioned in the ascending aorta through the right radial artery. When the activated clotting time exceeded 480, CPB was initiated and reached an output of 2.4 L/m2. A 23-mm balloon (Numed, Hopkinton, New York) was advanced through the aortic valve and valvuloplasty was performed. The 23-mm ReValving system was introduced and the valve advanced to its aortic position. The deployment was monitored through fluoroscopy and angiography guidance under full cardiopulmonary support (Fig 2).
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Fig 2. Postdeployment angiogram shows good opacification of the dominant left main/circumflex and anterior descending artery and no valve regurgitation.
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CPB lasted 26 minutes and was weaned uneventfully. A postimplantation angiogram (Fig 3) demonstrated correct positioning and absence of paravalvular leak. A transesophageal echocardiogram demonstrated a 1.4 cm2 aortic valve area, a .35 LVEF, and two trace paravalvular leaks.
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Follow-Up
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The patient was extubated 3 hours after the procedure and was kept under close surveillance in the intensive care unit for 5 days. Platelet consumption was monitored. After a nadir of 78,000 on day 3, the platelet count returned to within normal limits by discharge on day 9. The rest of the hospitalization was uneventful. Transthoracic echocardiograms on days 7, 30, and 90 confirmed the aortic valve area and the improved LVEF. By 3 months, her clinical status was improved but dependent of her pulmonary condition.
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Comment
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The CoreValve ReValving System has been used previously in more than 26 patients outside North America [5] after preliminary experimental data (more than 35 animal procedures) [3]. The indications for its use include severe symptomatic aortic stenosis in patients deemed unsuitable for open procedures by two cardiac surgeons. As the present prosthesis attains a final diameter of 23 mm, its use is restricted to annuli diameter between 19 mm and 24 mm. Patients with important thoracic or abdominal aortic atherosclerosis cannot undergo the procedure. The femoral arteries must be larger than 7 mm. When implantation is problematic, alternative strategies include implantation of a second prosthesis within the first implanted valve, or a high-risk open surgical procedure.
By April 22, 2006, the experience with the 21F catheter consisted of 42 patients with a mean Logistic Euroscore of 23.6%: procedural success in 39 of 42 patients; immediate aortic valve area, 1.6 cm2 (range, 1.1 to 2.3 cm2), 30-day mortality, 7; and mean follow-up, 5 months (range, 1 to 15 months). The other clinical percutaneous valvular option is the balloon-expandable Cribier-Edwards prosthesis (Edwards LifeSciences, Irvine, CA). Implantation of this prosthesis has been reported with antegrade, retrograde and transapical approaches, under cardiopulmonary bypass or fast ventricular pacing [6].
The CoreValve percutaneous aortic valve prosthesis can be safely implanted in selected patients with severe aortic stenosis who are not candidates for conventional surgery. Multidisciplinary contribution is necessary to offer the safest conditions and care for aortic valve stenosis in high-risk candidates.
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References
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- Bernstein AD, Parsonnet V. Bedside estimation of risk as an aid for decision-making in cardiac surgery Ann Thorac Surg 2000;69:823-828.[Abstract/Free Full Text]
- Horstkotte D, Loogen F. The natural history of aortic valve stenosis Eur Heart J 1988;9(Suppl E):57.[Abstract]
- Laborde J-C, Grube E, Tixier D, Bonan R. The CoreValve in the aortic positionIn: Hijazi ZM, Bonhoeffer P, Feldman T, Ruiz CE, editors. Transcatheter valve repair. 1st ed. Abingdon, Oxon, UK: Taylor and Francis; 2006. pp. 175-186.
- Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description Circulation 2002;106:3006-3008.[Abstract/Free Full Text]
- Grube E, Laborde JC, Zickmann B, et al. First report on a human percutaneous transluminal implantation of a self-expanding valve prosthesis for interventional treatment of aortic valve Cath Cardiovasc Intervent 2005;66:465-469.
- Webb JG, Chandavimol M, Thompson CR, et al. Percutaneous aortic valve implantation retrograde from the femoral artery Circulation 2006;113;:842-850.[Abstract/Free Full Text]
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Abstract
Introduction
