Six-month outcome of transapical transcatheter aortic valve implantation in the initial seven patients

Transcription

1 European Journal of Cardio-thoracic Surgery 31 (2007) Six-month outcome of transapical transcatheter aortic valve implantation in the initial seven patients Jian Ye *, Anson Cheung, Samuel V. Lichtenstein *, Sanjeevan Pasupati, Ronald G. Carere, Christopher R. Thompson, Ajay Sinhal, John G. Webb Abstract Divisions of Cardiac Surgery and Cardiology, St. Paul s Hospital, University of British Columbia, Vancouver, Canada Received 31 August 2006; received in revised form 3 October 2006; accepted 6 October 2006 Background: The current treatment of choice for symptomatic aortic stenosis is aortic valve replacement (AVR) with cardiopulmonary bypass (CPB), but AVR is associated with significant operative morbidity and mortality in elderly patients with multiple co-morbid conditions. We recently reported the first successful aortic valve implantation procedure (AVI) via a mini-thoracotomy and left ventricular apical puncture without cardiopulmonary bypass. We now report 6-month follow-up in our initial seven patients. Methods: Seven patients (77 10 years old) with symptomatic aortic stenosis were deemed to be non-surgical candidates for AVR and not suitable for a transfemoral percutaneous heart valve implantation due to aorto-iliac disease. The predicted 30-day operative mortality was 31 23% according to logistic Euroscore. Patients underwent minimally invasive transapical AVI. With the guidance of fluoroscopy and transesophageal echocardiography, balloon predilation was followed by deployment of a 26 mm Cribier Edwards TM valve (Edwards Lifesciences Inc., Irvine, CA) during rapid ventricular pacing to reduce forward flow and cardiac motion. Results: Valve implantation was successful in all seven patients. There were no intra-procedural mortalities or complications. Thirty-day operative mortality was 14%. One patient died at day 12 due to pneumonia. Two patients died from non-cardiac diseases at day 51 and 85. The remaining four patients completed 6-month follow-up. The aortic valve area increased from to and cm 2 at 1 and 6 months, respectively. The mean transaortic gradient was reduced from 32 8to10 5 and 11 8 mmhg at 1 and 6 months, respectively. Following AVI, none or trivial, mild, and moderate aortic regurgitation was observed in 4, 2, and 1 patients, respectively. There were no valve-related complications during the follow-up. Conclusion: Aortic valve implantation can successfully be performed via a minimally invasive apical approach without the need for cardiopulmonary bypass. The early results in this initial series are encouraging. This initial experience suggests that the minimally invasive transapical approach is a viable alternative for patients in whom open-heart surgery is not feasible or poses unacceptable risks. # 2007 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved. Keywords: Aorta; Catheter; Stenosis; Valves; Valvuloplasty 1. Introduction Aortic valve replacement (AVR) with cardiopulmonary bypass (CPB) has been the only treatment modality that offers both symptomatic relief and the potential for improved long-term survival, and hence is the treatment of choice for patients with symptomatic severe degenerative aortic stenosis [1]. Symptomatic patients managed medically have a poor prognosis [2 4] and the hope of durable benefit with balloon aortic valvuloplasty has not been realized [4 6]. However, since many patients with symptomatic severe Presented at the joint 20th Annual Meeting of the European Association for Cardio-thoracic Surgery and the 14th Annual Meeting of the European Society of Thoracic Surgeons, Stockholm, Sweden, September 10 13, * Corresponding authors. Address: Division of Cardiothoracic Surgery, St. Paul s Hospital, Room 489, 1081 Burrard Street, Vancouver, BC, Canada V6Z 1Y6. Tel.: ; fax: addresses: jye@providencehealth.bc.ca (J. Ye), svlichtenstein@providencehealth.bc.ca (S.V. Lichtenstein). aortic stenosis have significant co-morbidities, open heart AVR with CPB can be associated with an unacceptable perioperative mortality and morbidity. Several groups have pursued the development of transcatheter valves [7 13]. Percutaneous aortic valve implantation (AVI) in humans was first performed as a femoral transvenous procedure with antegrade access to the aortic valve [14 16]. Subsequently, Webb and co-workers [17,18] reported a femoral transarterial procedure. Our group s initial animal developmental work utilized direct balloon catheter implantation of an aortic valve through the left ventricular apex [12]. Recently, we reported the first successful case in which the transarterial delivery system was utilized to implant an aortic valve via the apex of the left ventricle without CPB in human [19,20]. Subsequently, we have reported our 1-month follow-up data in seven patients who underwent transapical transcatheter aortic valve implantation [21]. We have now completed 6-month clinical and echocardiographic follow-up in this cohort of patients /$ see front matter # 2007 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved. doi: /j.ejcts

2 J. Ye et al. / European Journal of Cardio-thoracic Surgery 31 (2007) who underwent transapical aortic valve implantation via a left mini-thoracotomy without CPB. 2. Methods The procedure was approved by the Therapeutic Products Directorate, Department of Health and Welfare, Ottawa, Canada, for compassionate clinical use in patients deemed not to be candidates for routine surgery and unsuitable for percutaneous trans-femoral arterial valve implantation Patients All patients had symptomatic severe aortic stenosis and were judged to be at unacceptably high risk for routine openheart AVR with CPB because of significant co-morbidity. Mortality risk as estimated by logistic Euroscore [22] was 31 23%. Patients were initially assessed for percutaneous transfemoral arterial valve implantation but were unsuitable due to atherosclerosis or unfavorable anatomy in the aorta and/or ilio-femoral arteries. The clinical characteristics of our initial seven patients are shown in Table 1. The Euroscore of each patient is listed in Table 1. Three patients (Patients 2, 4, and 5) had low Euroscore, however, they were not accepted for conventional AVR because in patient 2 conventional AVR was abandoned due to porceline aorta, patient 4 had multiple stroke with dementia, and patients 5 had end-stage lung disease Prosthetic valve system The Cribier Edwards TM valve (Edwards Lifesciences Inc., Irvine, CA) is constructed from a tubular slotted stainless steel stent with an attached equine pericardial trileaflet valve (Fig. 1). A sewn fabric cuff covers the left ventricular portion of the prosthesis. In-vitro durability of the prosthetic valve has been repeatedly demonstrated to be in excess of 200 million Table 1 Patient characteristics cardiac cycles, corresponding to over 5 years of life. Valves are supplied sterile in glutaraldehyde. Currently, only 23 and 26 mm external diameter prostheses are available for transapical use. Based on our percutaneous experience, the 26 mm prosthesis was considered appropriate for an echocardiographic annulus diameter of mm. A mechanical crimping device is utilized to attach the prosthesis onto a specially constructed balloon deployment catheter. In these initial apical access cases, we utilized the catheter delivery system designed for percutaneous femoral arterial access [17]. For the transapical approach, the occlusive fabric skirt must be mounted proximally on the balloon catheter. In this system, the balloon delivery catheter shaft is contained within a steerable guiding catheter that can be actively flexed by rotation of an external handle Procedure Patients were premedicated with aspirin, clopidogrel, and vancomycin. Procedures were performed by a team of cardiac surgeons and cardiologists in an operating room equipped with fluoroscopy. General anesthesia was utilized. Double lumen intubation was found to be unnecessary because lung deflation was not required during the procedure. We now use single lumen intubation in all cases. The apex of the left ventricle was identified by palpation and fluoroscopy. The pleural space overlying the apex (the fifth or sixth intercostal space) was entered via an approximately 5 cm anterolateral mini-thoracotomy. The pericardium over the apex of the left ventricle was identified and opened. Temporary epicardial ventricular pacing wires were placed on the left ventricle. Reliable capture was assured at a rate of between 160 and 220 beats per minute with a reduction in systemic systolic arterial pressure to below 60 mmhg. During valvuloplasty and prosthesis deployment, rapid pacing was utilized to minimize transaortic flow and cardiac motion [19,21]. Characteristic Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Patient 6 Patient 7 Age (year)/sex 76/F 77/F 76/M 70/M 63/M 90/M 91/M Body mass index Hypertension Yes No Yes Yes No Yes No Diabetes Yes No No Yes No No No Limiting lung disease Yes No No No Yes No No CAD Yes Yes Yes Yes Yes Yes Yes Prior CABG No No Yes No Yes No No Stroke No No No Yes No Yes Yes Atrial fibrillation No No No Yes No Yes No Severe PVD Yes Yes Yes No No Yes Yes GFR* <60 No Yes No No No No No Chest radiation No No No No Yes No No Porcelain aorta Yes Yes No No No No No Pulmonary HTN Yes No No No No Yes Yes LVEF (%) NYHA class Angina No No No No Yes Yes Yes Syncope No No No No No Yes No Logistic Euroscore CAD, coronary artery disease; CABG, coronary artery bypass; PVD, peripheral vascular disease; GFR, glomerular filtration rate; HTN, hypertension; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association.

3 18 J. Ye et al. / European Journal of Cardio-thoracic Surgery 31 (2007) Fig. 1. (A) The prosthesis is constructed of stainless steel stent incorporating an equine pericardial trileaflet valve and fabric cuff. (B) The prosthesis is crimped onto a valvuloplasty balloon catheter. The thin portion of the left ventricular apex was identified by finger palpation and confirmed by simultaneous transesophageal echocardiographic imaging (TEE). Two paired orthogonal U-shaped sutures with pledgets were placed into the myocardium and passed through tensioning tourniquets. Heparin was administered to achieve an activated clotting time of >250 s. An arterial needle puncture allowed placement of a 7 French sheath through the apex into the left ventricular cavity utilizing a standard over the wire technique. A wire (0.035 in. J-curve Amplatz extra stiff TM, Cook Inc.) was advanced through the aortic valve, around the arch and into the descending aorta for stability. If necessary a balloon catheter (Berman TM, Cook Inc.) was utilized to direct the wire in the direction of arterial flow past mitral chordae and around the aortic arch (rarely required). The 7F sheath was then exchanged for a 14 French sheath. A valvuloplasty balloon (20 22 mm, Z-Med TM, Numed Inc., Hopkington, NY) was advanced over the wire to the level of the ascending aorta, evacuated of air and test inflated with diluted contrast. The balloon was withdrawn to the level of the valve as determined by fluoroscopy and TEE. Rapid pacing was initiated and when an adequate reduction in systemic arterial pressure was achieved the balloon was rapidly inflated and deflated [19,21]. The 14 French sheath was exchanged over the wire for a 24 French sheath for valve delivery. The prosthetic valve mounted on a delivery balloon supported by a steerable catheter was introduced through the sheath over the Amplatzer wire. The prosthetic valve was advanced to the aortic valve and placed at the level of fluoroscopically visible valvular calcium. Aortic root angiography via a pigtail catheter introduced from the femoral artery and TEE were used to further aid positioning. When an adequate reduction in systemic arterial pressure was achieved with rapid pacing, the prosthetic valve was deployed using a rapid manual inflation/deflation of the delivery balloon (Fig. 2). Following deployment, valve function was assessed by Fig. 2. Positioning of the prosthetic valve was assessed with TEE and aortography and rapid deployment of the prosthetic valve performed under rapid ventricular pacing.

4 J. Ye et al. / European Journal of Cardio-thoracic Surgery 31 (2007) Table 2 Procedural characteristics Characteristic N = 7 patients (%) Fig. 3. Transesophageal echocardiogram revealed that the tissue valve was well seated with unrestricted leaflet opening. TEE (Fig. 3) and angiography. In two of the seven patients, paravalvular insufficiency was excessive and dilatation of the prosthesis was repeated. After removal of the left ventricular sheath, hemostasis was secured with the previously placed pledgeted sutures. The pericardium was approximated to prevent myocardial herniation but allow drainage. A left chest tube was placed [19,21]. Patients were maintained on aspirin indefinitely and clopidogrel for at least 1 month. Transthoracic echocardiography was performed prior to discharge or transfer to another hospital. The authors did not observe any obstruction of coronary ostia in this cohort of patients after the deployment of the tissue valve Follow-up All patients have been carefully followed by both cardiac surgeons and cardiologists. Clinical assessment was performed by either the patients cardiologists or cardiac surgeons. Follow-up echocardiography was performed at 1 and 6 months. We have completed 6-month follow-up in this initial cohort of seven patients who underwent minimally invasive transapical aortic valve implantation Statistical analysis Normally distributed data were reported as mean stanstandard deviation. Non-parametric data were reported as median (inter quartile range). No statistical analysis was performed due to limited sample size in this series. 3. Results 3.1. Intraoperative results Transapical aortic valve implantation via a left minithoracotomy without CPB was successfully performed in all Aortic annulus diameter (mm) mm aortic prosthesis 7 patients 100 Valvuloplasty successful 7 patients 100 Valve implantation successful 7 patients 100 Post-deployment re-dilatation 2 patients 33 Procedure time (min) Fluoroscopy time (min) 16 4 Ventilator time (min) Chest tube removal (days) Blood loss in 24 h (ml) Blood transfusion 2 patients 29 Mortality at 30 days 1 patients 14 Median hospital stay (days) (6 patients) a 8 (6,14) b a Prior to discharge or transfer. Median (IQR). seven patients with severe symptomatic aortic stenosis. All patients received 26 mm diameter prostheses. Paravalvular regurgitation was moderate by TEE in two patients in whom redilation resulted in further expansion of the prosthesis and a satisfactory reduction in paravalvular regurgitation. At the completion of the procedure, aortic insufficiency grade was 1 (1,2) by TTE. There was no obstruction of coronary ostia in this cohort of patients and no intraoperative complications or mortality. We did not experience any hemostatic problems in closing the puncture site of the left ventricular apex. All patients tolerated the procedure very well. Procedural characteristics are shown in Table Clinical follow-up Of the first seven patients, five patients were discharged home and one transferred to another hospital for convalescent care. The 7th patient, who had a predicted surgical mortality of 58% based on the logistic Euroscore, died at day 12 due to pneumonia. The median hospital stay prior to discharge or transfer was 8 (6,14) days. The delayed hospital discharge was mainly due to preoperatively comorbidities. There were no significant postoperative complications, except pleural effusion requiring tube drainage in one patient, and lower urinary tract infection in another patient. At 1- and 6-month follow-up, preoperative symptoms related to severe aortic stenosis were either resolved or significantly improved. Postoperative NYHA class remained unchanged in only one patient who had end-stage lung disease that existed preoperatively. This patient died from his end-stage lung disease at postoperative day 51. Another patient died from cancer at day 85. The other four patients continue to do well with significantly improved quality of life Echocardiographic follow-up Echocardiography was performed prior to hospital discharge (seven patients), and at 1 month (six patients) and 6 month (four patients). Echocardiography performed prior to hospital discharge demonstrated (1) well-seated aortic valves with normal valve function in all seven patients, (2) moderate paravalvular regurgitation in one patient, mild paravalvular regurgitation in two patients, and non or trivial

5 20 J. Ye et al. / European Journal of Cardio-thoracic Surgery 31 (2007) Table 3 Echo characteristics Echo parameter Pre procedure, N = 7 Post procedure N = 7 1 month, N = 6 6 months, N = 4 Aortic valve area a Aortic mean gradient Ejection fraction 49% 9% 52% 13% 54% 8% 60% 9% Aortic regurgitation b [Grade:1 4] c 1 (1,2) 1 (1,2) 2 (1,2) 1 (0,2) Mitral regurgitation b [Grade: 1 4] c 3 (2,3) 2 (1,4) 2 (1,2) 2 (1,2) a Unable to calculate in three patients. Regurgitation reported: median (IQR). c Regurgitation was graded as 1:trivial; 2:mild; 3:moderate; 4:severe. paravalvular regurgitation in four patients, (3) aortic valve area of cm 2, and (4) mean transaortic gradient of 10 7 mmhg. These measurements were maintained at 1- and 6-month follow-up (Table 3). In no patient did paravalvular insufficiency appear clinically significant. Decreases in mitral regurgitation were observed at 1- and 6-month echocardiographic follow-up (Table 3). LV function shows an improving trend at 6-month follow-up (Table 3). 4. Discussion Aortic valve replacement is the treatment of choice in patients with severe symptomatic acquired aortic stenosis, offering both symptomatic relief and the potential of improved long-term survival [1]. Symptomatic patients managed medically have a poor prognosis [2 4]. Balloon valvuloplasty is palliative and although it may result in temporary relief of symptoms, benefit is modest and restenosis certain [6,23]. Unfortunately, many potential surgical candidates have significant co-morbid conditions and open-heart surgery with CPB may pose risks that are unacceptable to them or their physicians. According to the Society of Thoracic Surgery Database ( ) surgical aortic valve replacement carries a rate of serious complication or mortality of 16.8%. Operative risk is increased in the setting of co-morbid conditions including advanced age [24,25]. Our patients were judged poor candidates for routine surgery with an estimated logistic Euroscore operative mortality of 31 23%. The observed 30-day mortality of 14% is encouraging. The feasibility of percutaneous valve implantation was first demonstrated in an animal model by Anderson et al. [7]. Subsequently several groups, including our own, pursued the development of percutaneous heart valves [7 13]. Percutaneous aortic valve implantation in humans was first performed as a transvenous transseptal procedure with antegrade access to the aortic valve by Cribier et al. [14,15]. However, the technical complexity and associated risks with this procedure appear likely to limit its widespread application. Authors reported the development of a transarterial retrograde technique with which initial results have been favorable [17,18]. Evaluation of this procedure is ongoing and remains encouraging. Although the transfemoral arterial procedure has proven successful, some patients are poorly suited to this approach due to femoral, iliac or aortic size, tortuosity, aneurysm, atheroma, or dissection. This has led to the further development of an alterative approach via the left ventricular apex for aortic valve implantation, which is independent of central and/or peripheral arterial size, anatomy, or diseases. Our initial percutaneous valve development had utilized direct balloon catheter implantation from the left ventricular apex in a porcine model [12]. Subsequently, we reported the first successful case of aortic valve implantation via a left mini-thoracotomy and the left ventricular apex without CPB in human [19] and our initial experience in this approach [21]. Valvuloplasty data suggests that stroke is a surprisingly infrequent occurrence despite heavy aortic valve calcification [6,23]. It is likely that the calcific debris familiar to surgeons replacing the aortic valve results from violation of the aortic valve endothelium when resecting the valve. If this covering is kept intact during valvuloplasty and valve deployment, embolization does not occur despite displacement or even crumbling of the calcium within this covering. Coronary obstruction or stroke could conceivably occur due to embolization of friable valvular debris, although this has not been observed with percutaneous valve implantation [17]. In this initial series of seven patients, aortic valvuloplasty and deployment of the aortic prostheses were not associated with stroke or coronary obstruction. Device embolization was an unpredictable concern during early percutaneous experience. However, with accurate positioning, sizing, and deployment techniques, prosthesis embolization appears to be rare as reflected in this initial apical access experience. Furthermore, the inappropriate positioning of prosthesis may be less frequent using the left ventricular apex approach given the nature of its antegrade approach and very short distance to reach the valve. The transapical transcatheter approach to aortic valve implantation is safe and reliable with minimal operative risks and good early outcome as reflected in this series. The postoperative recovery, length of hospital stay, and late survival are dependent on preoperative comorbidities. This minimally invasive aortic valve implantation appears to be an acceptable approach to symptomatic aortic stenosis in patients who are deemed to be non-surgical candidates. The procedure provides immediate relief of AS-related symptoms and significantly improves quality of life. Trivial to mild paravalvular regurgitation appears to be common immediately after successful deployment of prosthesis. However, no worsening of the paravalvular regurgitation was observed during the 6-month follow-up, and in no patient did the residual paravalvular leak appear clinically significant in this series. Significant prosthetic regurgitation was not observed in any patients, and aortic valvular area and transvalvular gradient were stable during 6-month follow-up.

6 J. Ye et al. / European Journal of Cardio-thoracic Surgery 31 (2007) In summary, aortic valve implantation is feasible via a minimally invasive apical approach without the need for cardiopulmonary bypass. The early results in the initial series are favorable. This initial experience suggests minimally invasive transapical approach is a new, viable alternative for patients in whom open-heart surgery is not feasible or poses unacceptable risks. References [1] Schwarz F, Baumann P, Manthey J, Hoffmann M, Schuler G, Mehmel HC, Schmitz W, Kubler W. The effect of aortic valve replacement on survival. Circulation 1982;66(5): [2] Ross JJ, Braunwald E. Aortic stenosis. Circulation 1968;38(1 Suppl):61 7. [3] ACC/AHA. ACC/AHA guidelines for the management of patients with valvular disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Patients with Valvular Heart Disease). J Am Coll Cardiol 1998;32: [4] Otto CM, Mickel MC, Kennedy JW, Alderman EL, Bashore TM, Block PC, Brinker JA, Diver D, Ferguson J, Holmes Jr DR. Three-year outcome after balloon aortic valvuloplasty: insights into prognosis of valvular aortic stenosis. Circulation 1994;89: [5] Lieberman EB, Bashore TM, Hermiller JB, Wilson JS, Pieper KS, Keeler GP, Pierce CH, Kisslo KB, Harrison JK, Davidson CJ. Balloon aortic valvuloplasty in adults: failure of procedure to improve long-term survival. J Am Coll Cardiol 1995;26: [6] Feldman T. Core curriculum for interventional cardiology: percutaneous valvuloplasty. Catheter Cardiovasc Interv 2003;60: [7] 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: [8] Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde FMBL. Trans-catheter implantation of balloon-expandable prosthetic heart valves, early results in an animal model. Circulation 2001;104(Suppl 2):I552. [9] Boudjemline Y, Bonhoeffer P. Steps toward percutaneous aortic valve replacement. Circulation 2002;105: [10] Boudjemline Y, Bonhoeffer P. Percutaneous implantation of a valve in the descending aorta in lambs. Eur Heart J 2002;23: [11] Boudjemline Y, Bonhoeffer P. Steps toward percutaneous aortic valve replacement. Circulation 2002;105(6): [12] Webb JG, Munt B, Makkar R, Naqvi T, Dang N. A percutaneous stentmounted valve for treatment of aortic or pulmonary valve disease. Cathet Cardiovasc Interv 2004;63: [13] Grube E, Laborde JC, Zickmann B, Gerckens U, Felderhoff T, Sauren B, Bootsveld A, Buellesfeld L, Iversen S. First report on a human percutaneous transluminal implantation of a self-expanding valve prosthesis for interventional treatment of aortic valve stenosis. 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Validation of european system for cardiac operative risk evaluation (EuroSCORE) in North American cardiac surgery. Eur J Cardiothorac Surg 2002;22(1): [23] O Neill WW. Predictors of long-term survival after percutaneous aortic valvuloplasty: report of the Mansfield Scientific Balloon Aortic Valvuloplasty Registry. J Am Coll Cardiol 1991;17(1): [24] Sundt TM, Bailey MS, Moon MR, Mendeloff EN, Huddleston CB, Pasque MK, Barner HB, Gay Jr WB. Quality of life after aortic valve replacement at the age of >80 years. Circulation 2000;102(19 Suppl 3):III70 4. [25] Mullany CJ. Aortic valve surgery in the elderly. Cardiol Rev 2000;8: Appendix A. Conference discussion Dr O. Oto (Izmir, Turkey): As I had presented at the ESC meeting in Barcelona this year, this incision can be done over the aorta easily with just 5 cm of incision, and minimally invasive aortic valve replacement can be easily done with the pump with completely conventional surgical armamentarium. Then this operation can cover any surgical risks, any high-risk patients as well. So while you are making an incision, why don t you do it with a routine conventional surgical armamentarium so that we can perform it on any case with any kind of valve? Dr Ye: You mentioned minimally invasive aortic valve replacement. I believe that to do the aortic valve replacement you still need use cardiopulmonary bypass, right? You still need cardiopulmonary bypass during the minimally invasive procedure. For this procedure basically you don t need any cannulation or bypass equipment. Our patients were sick with very high operative risk. In some patients predicted mortality was 50 or 60%. And I believe if you don t use cardiopulmonary bypass, perioperative mortality and morbidity would be significantly reduced. This approach without use of cardiopulmonary bypass system would be safer for the very elderly person or sick patient. Dr H. Alsisi (Cairo, Egypt): First, do you have any way to measure the degree of calcification that in some cases you will not be able to dilate the aortic valve before inserting this valve through the apex of the heart and the risks of emboli from the calcific lesions when you extend the balloon and comment about the paravalvular leak, or any failure? Did you have any failure to dilate the aortic valve, and what do you do if there is severe aortic regurg and you should not inflate the valve at this time? Dr Ye: I have not had this kind of situation so far. For a severely calcified aortic valve, there is a possibility of having difficulty to dilate the valve. In our series we haven t seen this kind of problem. Dr Alsisi: What is the backup strategy if something happens like this? You will have the bypass ready to go immediately on bypass, or what do you do preoperatively if this situation would happen? It is not in the mind that this might happen? Dr Ye: I guess there is a possibility, but actually I haven t had this experience. I just want to emphasize that this procedure is only for a compassionate use in our patient group. So basically the patient would not be a surgical candidate. We already discussed it with the patient before the procedure. All the patients were assessed by two cardiologists and two cardiac surgeons independently to determine if the patient was a surgical candidate or not. If there is anyone who is a surgical candidate, we will not proceed with this procedure. Before the procedure the patients were told that if any disaster happened, we would not going to put them on the pump. That is why there is no cardiopulmonary bypass pump in OR.