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Eur J Cardiothorac Surg 2007;31:9-15. doi:10.1016/j.ejcts.2006.10.034
Copyright © 2007, European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved
a Department of Cardiac Surgery, Heartcenter, University Leipzig, Leipzig, Germany
b Department of Cardiac Surgery, Cardiopulmonary Research Science and Technology Institute, Dallas, TX, USA
c Department of Thoracic and Cardiovascular Surgery, JW-Goethe University, Frankfurt, Germany
d Department of Cardiology, Heartcenter, University Leipzig, Leipzig, Germany
Received 13 October 2006; received in revised form 29 October 2006; accepted 30 October 2006.
* Corresponding author. Address: Universität Leipzig, Herzzentrum, Klinik für Herzchirurgie, Strümpellstr. 39, 04289 Leipzig, Germany. Tel.: +49 341 865 1424; fax: +49 341 865 1452. (Email: walt{at}medizin.uni-leipzig.de).
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Abstract |
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 Top Abstract 1. Introduction2. Methods3. Results4. DiscussionReferences |
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Key Words: Aortic valve replacement • Transapical aortic valve implantation • Minimally invasive cardiac surgery • Beating heart cardiac surgery • Transcatheter valve implantation
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1. Introduction |
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TopAbstract1. Introduction2. Methods3. Results4. DiscussionReferences |
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1 cm2
[3]. Current conventional surgical techniques consist of partial or complete sternotomy with extracorporeal circulation (ECC) and cardioplegic cardiac arrest. In parallel with an overall increasing life expectancy more and more elderly patients are being diagnosed with AS. Besides older age additional perioperative risk factors may be present such as low ejection fraction, pulmonary hypertension, respiratory dysfunction, renal failure or peripheral arterial occlusive disease. Such co-morbidities are associated with an increased perioperative risk, particularly for mortality. Truly minimally invasive strategies may be an important treatment option for such high-risk patients. Important areas of development include minimizing the overall surgical trauma by potentially avoiding a sternotomy, avoiding the use of ECC and implanting the prostheses on the beating heart thereby avoiding cardiac arrest.
The aim of our study was to evaluate the feasibility of minimally invasive transapical aortic valve implantation (TAP-AVI) on the beating heart in high-risk patients.
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2. Methods |
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TopAbstract1. Introduction2. Methods3. Results4. DiscussionReferences |
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2.1 Patient selection
Patient selection was performed on the basis of an increased perioperative risk profile according to the EuroSCORE scale [6]. Patients with 
9 points indicating a risk for mortality of >11% according to the logistic EuroSCORE were considered suitable for inclusion into the study. Detailed echocardiographic analysis was then performed in order to delineate the diameter of the aortic annulus as well as the distribution of cusp calcification, presence of fused commissures, tricuspid or biscuspid pathology as well as presence of severe eccentric calcification. Patients with an aortic annulus 24 mm and equally distributed calcification were considered suitable for inclusion in the study. The therapeutic option of TAP-AVI was discussed extensively with the patients and family members. This discussion focused on the overall risk profile of the individual patient, on the preoperative activities of daily living and the motivation of the individual patient, and on the ongoing results of the new technique. All patients considered suitable for inclusion into the study gave informed consent; no one opted for a conventional surgical approach.
2.2 Cribier-Edwards prosthesis
The Cribier-Edwards prosthesis is a pericardial xenograft mounted on a stainless steel stent and is available in two sizes—23 mm and 26 mm (Edwards Lifesciences, Irvine, CA, USA). Comparable to other pericardial xenografts, the valve has three cusps and three commissures. The stainless steel stent has a very low profile when fully expanded. The lower inflow portion of the valve is covered with polyethylene terephthalate (PET) cloth. The prosthesis is the same device as used in recent clinical percutaneous approaches [7–9] (see Fig. 1
). The sutureless stent-fixed aortic valve was prepared for transapical antegrade delivery under sterile conditions in the operating room by a technician just prior to implantation. The delivery catheter was flushed with a heparinized saline solution. The deployment balloon was primed with a mixture of saline and contrast that was free of air. The valve was crimped onto the deployment balloon so that it was equidistant between two radiopaque markers and was able to be passed through the 33F transapical delivery sheath. All valve deployments were performed using standard volumetric inflation of the balloon.
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2.4 Transapical aortic valve implantation (TAP-AVI): operative technique
The patients were placed in a supine position with the left chest slightly elevated. The left sided femoral vessels were dissected, either for cannulation for ECC (on pump procedure) or to place a venous guidewire (off pump procedure) for safety reasons in order to be prepared for fast cannulation. In addition a femoral arterial sheath (6F) was inserted and an aortic root pigtail catheter for angiographic visualization was placed. High dose heparin (300 IU/kg) was given for on-pump cases, and low dose heparin (5000 IU) was used for off-pump procedures with a target activated clotting time of 180–200 s. An anterolateral minithoracotomy (5–7 cm) was then performed in the fifth intercostal space to access the apex of the heart. The pericardium was incised longitudinally and fixed with stay sutures allowing persistent ventilation of the lungs. A bipolar epicardial pacing wire was placed and tested. Two apical purse-string sutures with Teflon felt pledgets were placed with an inner diameter of approximately 2–3 cm. The left ventricular apex was punctured and a soft guidewire passed antegradely across the stenotic aortic valve under fluoroscopic and echocardiographic monitoring. A 14F soft sheath was introduced and positioned across the aortic valve. A 035'' super-stiff guide-wire (Amplatz super-stiff; 260 cm, Boston Scientific) was then positioned across the aortic arch and ‘anchored’ into the descending aorta. The sheath was partially withdrawn and a 20 mm balloon valvuloplasty catheter positioned under fluoroscopic and echocardiographic guidance. Balloon valvuloplasty was performed once during a brief episode of rapid ventricular pacing (150/min.). The balloon catheter and apical sheath were withdrawn and a 33F transapical delivery sheath inserted bluntly. The valve was then inserted using the specific application system. After careful de-airing of the sheath the valve was positioned so that the annulus bisects the stent. Fluoroscopic and echocardiographic imaging was used to position the valve and single shot aortic root angiography was used to confirm the intraannular position below the coronary ostia. During a second brief episode of rapid ventricular pacing, the valve was near instantaneously implanted using rapid balloon inflation. Rapid pacing was then stopped and hemodynamic function allowed to recover. Repeat dilatation was indicated in the presence of moderate paravalvular leakage. Valve function was immediately assessed by using angiographic and echocardiographic visualization. The transapical sheath was removed and the apex securely closed with the purse-string sutures. ECC was weaned, if necessary, and the cannulas removed and protamine administered. Intercostal blockade was performed using Ropivacaine. The pericardium was partially closed over the apex and a left lateral chest tube inserted. The incision was closed in a standard fashion. A schematic illustration of TAP-AVI is displayed in Fig. 2
, and perioperative images are displayed in Fig. 3
a–c. Postoperative device specific medical therapy consisted only of aspirin 100 mg daily.
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3. Results |
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TopAbstract1. Introduction2. Methods3. Results4. DiscussionReferences |
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Valve implantation was successful in 29 of 30 patients (96.7%). One patient with severe eccentric calcification of one of the native aortic valve cusps required early conversion to full sternotomy: In this patient balloon dilatation was more gradual rather than instantaneous. The valve slipped downwards due to the eccentric calcification, resulting in a fixed position in the left ventricular outflow tract and subsequent severe mitral valve incompetence. Conversion to conventional valve replacement was successfully performed.
There was no neurological event and no stroke in any of the patients. Perioperative laboratory examination did not reveal any relevant increase in myocardial enzymes despite performing apical puncture and applying apical purse-string sutures. Further perioperative results and early postoperative outcomes are summarized in Table 3 .
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3.3 Morbidity and mortality
In-hospital morbidity is summarized in Table 4
. A total of seven patients had a completely uneventful postoperative course without any complications. Three patients (10%) died in-hospital, all due to non-valvular causes. One patient died on postoperative day (POD) 86 and one on POD 18 due to an acute abdomen followed by multiorgan failure. The third patient suffered severe biventricular myocardial failure preoperatively during induction of anesthesia. Valve implantation was performed during resuscitation as salvage procedure. Despite good valve function the patient subsequently died on postoperative day 3 due to low cardiac output syndrome. Autopsy confirmed correct valve positioning and patent coronary arteries in all three patients who died.
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3.4 Echocardiographic results
Echocardiographic results for the 29 patients who successfully underwent valve implantation are shown in Table 5
. Preoperative and early postoperative (pre-discharge) transthoracic echocardiographic measurements are displayed. A small amount of aortic incompetence was diagnosed in 14 patients prior to discharge. Incompetence was transvalvular in five (all mild) and paravalvular in nine of these patients, respectively. None of these patients had any signs of hemolysis or clinically or hemodynamically important insufficiency.
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4. Discussion |
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TopAbstract1. Introduction2. Methods3. Results4. DiscussionReferences |
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4.1 Concept of TAP-AVI
We believe the concept of transapical aortic valve implantation (TAP-AVI) is logical and feasible due to several factors: (a) Previous experience of uncomplicated left ventricular apical deairing after open heart surgery that has been safely performed for decades. (b) The relatively easy access to the left ventricular apex via a standard anterolateral minithoracotomy. (c) The relatively short distance from to the left ventricular apex to the aortic valve, allowing for exact and direct manipulation of any device. (d) The antegrade direction employed when traversing the severely stenosed native valve as well as the antegrade introduction of the prosthesis. All these factors may result in the transapical procedure being the preferred approach when compared to the retrograde transfemoral arterial and transseptal femoral venous approaches that have been applied [7–9]. Several experimental studies have been performed prior to starting clinical studies, also proving the feasibility as well as the safety of the transapical techniques [4,5,11]. TAP-AVI procedure will be a valuable and promising technique in the future.
4.2 Other approaches for transcatheter valve implantation/research activities
There may be several other approaches for transcatheter heart valve implantation in the future, reflected by multiple research efforts in this field [11–16]. One major issue to be determined is the optimal stent material. Two options currently exist: Nitinol, a self-expanding material that is introduced using an application system or steel, which requires active balloon dilatation. At present CoreValve, a porcine pericardial valve mounted on a nitinol stent with transfemoral retrograde delivery, is being studied at several centers. Initial single center clinical results in 25 patients have been recently presented [17]. The present study compares favorably to those results, especially in view of a significantly higher patient risk profile and a lower in hospital mortality.
4.3 Patient selection
Patient selection is the most critical factor determining the outcome of any clinical study. When performing a study on high-risk elderly patients, selection may be even more important. The current study is a consecutive series including all patients that met the inclusion criteria during the study period and that were considered as high risk for conventional surgery. Very few moribund patients were not accepted for surgical treatment during this time period at our institution. We usually do not consider any patient with severe symptomatic aortic valve stenosis to be a non-surgical candidate. Thus the study population presented reflects the upper edge risk profile of patients currently operated on for symptomatic aortic stenosis at our institution.
4.4 Clinical and hemodynamic results
This is a clinical series of 30 high-risk patients with severe aortic valve stenosis and significant co-morbidities. The high surgical risk of these patients is well reflected by a logistic EuroSCORE predicted risk for mortality of 27.1 ± 12.2% as well as by a significant number of additional morbidities as shown in Table 2. In view of these risks, the perioperative outcomes are excellent. We believe this can be attributed to the minimally invasive nature of TAP-AVI including avoidance of a sternotomy incision, implantation of the valves on the beating heart and thereby avoiding ischemia, and by avoiding ECC altogether in a significant proportion of patients.
Fortunately there were no neurological events in this study. This is extremely encouraging as we could prove that the rate of neurological events is low even in patients undergoing aortic valvotomy in presence of calcified cusps.
In the early postoperative period, however, there were some morbidities as indicated in Table 4. This is not unexpected, as we were treating relatively old patients (mean age 82 years) with substantial co-morbidities, as mentioned before.
Regarding hemodynamic function, all patients had complete and instantaneous relief of aortic stenosis after valve implantation. Excellent hemodynamic function of the Cribier-Edwards prosthesis was documented by postoperative echocardiographic examinations, as summarized in Table 5. The excellent hemodynamic function can be attributed to the valve design with a short and, most importantly, relatively low-profile stent. The valve design minimizes valve-intrinsic obstruction, which may be present with conventional stented xenografts. The very low maximum blood flow velocities compare very well to conventional stented or even stentless xenografts in the aortic position.
Potential paravalvular leakage is the major concern when using transcatheter valve implantation techniques. To minimize this risk, we applied an oversizing technique whereby the implanted valve size is at least 2 mm larger than the native aortic valve annulus. In addition, the distribution of annular as well as native aortic valve cusp calcification is an important consideration. Patients presenting with equally distributed calcification will probably have a lower risk of suffering post-implant paravalvular leakage. In this series we did not observe any relevant clinical consequences for the patients with postoperative paravalvular leakage. In the future there may be additional techniques, such as self-sealing cuffs for example, to further minimize the risk of paravalvular leakage.
4.5 Team approach
TAP-AVI is a new technique combining conventional surgical knowledge with techniques traditionally applied in the catheterization laboratory, usually by cardiologists. Availability of a modern angiographic system is of utmost importance for good visualization during valve implantation and thus a successful outcome. A hybrid operating room is the optimal setting for successful implementation of a transcatheter valve implantation program. In addition, good cooperation between all disciplines involved – cardiac surgeons, cardiologists and anesthesiologists – will lead to further establishment of these new techniques and successful treatment of high-risk patients.
4.6 Minimally invasive transapical aortic valve implantation—a clinical reality
Minimally invasive off pump transcatheter aortic valve implantation is a clinical reality. The most important difference between conventional and transcatheter aortic valve implantation is the attitude of surgeons and cardiologists towards these techniques. Open-mindedness together with flexibility will lead to further successful applications. Some years ago neither surgeons nor cardiologists would have foreseen that aortic valve implantation would be possible on the beating heart, without ECC and without a sternotomy. Thus TAP-AVI has rapidly evolved into a truly minimally invasive procedure for the treatment of high-risk patients suffering symptomatic aortic valve disease.
4.7 Future direction
Based on these successful initial results, we believe TAP-AVI will be performed by more and more groups at different centers. However, some skepticism remains within the surgical and cardiological communities. Therefore prospective randomized studies should be performed, comparing transapical as well as transfemoral transcatheter valve implantation techniques, to the gold standard of conventional aortic valve replacement surgery. Future protocols are being developed at present.
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Acknowledgments |
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References |
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TopAbstract1. Introduction2. Methods3. Results4. DiscussionReferences |
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J. G. Webb Percutaneous Aortic Valve Replacement Will Become a Common Treatment for Aortic Valve Disease J. Am. Coll. Cardiol. Intv., April 1, 2008; 1(2): 122 - 126. [Abstract] [Full Text] [PDF]
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N. V. Vasilyev, I. Melnychenko, K. Kitahori, F. P. Freudenthal, A. Phillips, R. Kozlik-Feldmann, I. S. Salgo, P. J. del Nido, and E. A. Bacha Beating-heart patch closure of muscular ventricular septal defects under real-time three-dimensional echocardiographic guidance: A preclinical study J. Thorac. Cardiovasc. Surg., March 1, 2008; 135(3): 603 - 609. [Abstract] [Full Text] [PDF]
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T. Walther, J. Kempfert, M. A. Borger, J. Fassl, V. Falk, J. Blumenstein, M. Dehdashtian, G. Schuler, and F. W. Mohr Human Minimally Invasive Off-Pump Valve-in-a-Valve Implantation Ann. Thorac. Surg., March 1, 2008; 85(3): 1072 - 1073. [Abstract] [Full Text] [PDF]
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R. Zegdi, V. Ciobotaru, M. Noghin, G. Sleilaty, A. Lafont, C. Latremouille, A. Deloche, and J.-N. Fabiani Is it reasonable to treat all calcified stenotic aortic valves with a valved stent? Results from a human anatomic study in adults. J. Am. Coll. Cardiol., February 5, 2008; 51(5): 579 - 584. [Abstract] [Full Text] [PDF]
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L. K. von Segesser Impact Factor 2.106 reached by the European Journal of Cardio-thoracic Surgery on its 20th anniversary in 2007 Eur. J. Cardiothorac. Surg., February 1, 2008; 33(2): 141 - 142. [Full Text] [PDF]
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 T. Walther, P. Simon, T. Dewey, G. Wimmer-Greinecker, V. Falk, M. T. Kasimir, M. Doss, M. A. Borger, G. Schuler, D. Glogar, et al. Transapical Minimally Invasive Aortic Valve Implantation: Multicenter Experience Circulation, September 11, 2007; 116(11_suppl): I-240 - I-245. [Abstract] [Full Text] [PDF]
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T. Walther, V. Falk, T. Dewey, J. Kempfert, F. Emrich, B. Pfannmuller, P. Broske, M. A. Borger, G. Schuler, M. Mack, et al. Valve-in-a-Valve Concept for Transcatheter Minimally Invasive Repeat Xenograft Implantation J. Am. Coll. Cardiol., July 3, 2007; 50(1): 56 - 60. [Abstract] [Full Text] [PDF]
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D. Kalavrouziotis, K. J. Buth, and J.-F. Legare Patient selection for minimally invasive aortic valve implantation Eur. J. Cardiothorac. Surg., July 1, 2007; 32(1): 188 - 188. [Full Text] [PDF]
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T. Walther, V. Falk, M. A. Borger, and F. W. Mohr Reply to Kalavrouziotis et al. Eur. J. Cardiothorac. Surg., July 1, 2007; 32(1): 189 - 190. [Full Text] [PDF]
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