www.elsevier.com/locate/ejctsEuropean Journal of Cardio-thoracic Surgery 31 (2007) 16—21

Six-month outcome of transapical transcatheter aortic valveimplantation 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

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

Abstract

Background: The current treatment of choice for symptomatic aortic stenosis is aortic valve replacement (AVR) with cardiopulmonary bypass(CPB), but AVR is associatedwith significant operativemorbidity andmortality in elderly patients withmultiple co-morbid conditions.We recentlyreported the first successful aortic valve implantation procedure (AVI) via a mini-thoracotomy and left ventricular apical puncture withoutcardiopulmonary bypass. We now report 6-month follow-up in our initial seven patients. Methods: Seven patients (77 � 10 years old) withsymptomatic aortic stenosis were deemed to be non-surgical candidates for AVR and not suitable for a transfemoral percutaneous heart valveimplantation due to aorto-iliac disease. The predicted 30-day operative mortality was 31 � 23% according to logistic Euroscore. Patientsunderwent minimally invasive transapical AVI. With the guidance of fluoroscopy and transesophageal echocardiography, balloon predilation wasfollowed by deployment of a 26 mm Cribier—EdwardsTM valve (Edwards Lifesciences Inc., Irvine, CA) during rapid ventricular pacing to reduceforward flow and cardiac motion. Results: Valve implantation was successful in all seven patients. There were no intra-procedural mortalities orcomplications. Thirty-day operative mortality was 14%. One patient died at day 12 due to pneumonia. Two patients died from non-cardiacdiseases at day 51 and 85. The remaining four patients completed 6-month follow-up. The aortic valve area increased from 0.7 � 0.3 to 1.8 � 0.7and 1.5 � 0.5 cm2 at 1 and 6 months, respectively. The mean transaortic gradient was reduced from 32 � 8 to 10 � 5 and 11 � 8 mmHg at 1 and 6months, 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 aminimally invasive apical approach without the need for cardiopulmonary bypass. The early results in this initial series are encouraging. Thisinitial experience suggests that the minimally invasive transapical approach is a viable alternative for patients in whom open-heart surgery is notfeasible 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 cardiopulmonarybypass (CPB) has been the only treatment modality thatoffers both symptomatic relief and the potential forimproved long-term survival, and hence is the treatmentof choice for patients with symptomatic severe degenerativeaortic stenosis [1]. Symptomatic patients managed medicallyhave a poor prognosis [2—4] and the hope of durable benefitwith 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 forCardio-thoracic Surgery and the 14th Annual Meeting of the European Societyof Thoracic Surgeons, Stockholm, Sweden, September 10—13, 2006.* Corresponding authors. Address: Division of Cardiothoracic Surgery, St.

Paul’s Hospital, Room 489, 1081 Burrard Street, Vancouver, BC, Canada V6Z1Y6. Tel.: +1 604 806 9349; fax: +1 604 806 8375.

E-mail addresses: jye@providencehealth.bc.ca (J. Ye),svlichtenstein@providencehealth.bc.ca (S.V. Lichtenstein).

1010-7940/$ — see front matter # 2007 European Association for Cardio-Thoracic Sdoi:10.1016/j.ejcts.2006.10.023

aortic stenosis have significant co-morbidities, open heartAVR with CPB can be associated with an unacceptableperioperative mortality and morbidity.

Several groups have pursued the development of trans-catheter valves [7—13]. Percutaneous aortic valve implanta-tion (AVI) in humans was first performed as a femoraltransvenous procedure with antegrade access to the aorticvalve [14—16]. Subsequently, Webb and co-workers [17,18]reported a femoral transarterial procedure. Our group’sinitial animal developmental work utilized direct ballooncatheter implantation of an aortic valve through the leftventricular apex [12]. Recently, we reported the firstsuccessful case in which the transarterial delivery systemwas utilized to implant an aortic valve via the apex of the leftventricle without CPB in human [19,20]. Subsequently, wehave reported our 1-month follow-up data in seven patientswho underwent transapical transcatheter aortic valveimplantation [21]. We have now completed 6-month clinicaland echocardiographic follow-up in this cohort of patients

urgery. Published by Elsevier B.V. All rights reserved.

J. Ye et al. / European Journal of Cardio-thoracic Surgery 31 (2007) 16—21 17

who underwent transapical aortic valve implantation via aleft mini-thoracotomy without CPB.

2. Methods

The procedure was approved by the Therapeutic ProductsDirectorate, Department of Health and Welfare, Ottawa,Canada, for compassionate clinical use in patients deemednot to be candidates for routine surgery and unsuitable forpercutaneous trans-femoral arterial valve implantation.

2.1. Patients

All patients had symptomatic severe aortic stenosis andwere judged to be at unacceptably high risk for routine open-heart AVR with CPB because of significant co-morbidity.Mortality risk as estimated by logistic Euroscore [22] was31 � 23%. Patients were initially assessed for percutaneoustransfemoral arterial valve implantation but were unsuitabledue to atherosclerosis or unfavorable anatomy in the aortaand/or ilio-femoral arteries. The clinical characteristics ofour initial seven patients are shown in Table 1. The Euroscoreof each patient is listed in Table 1. Three patients (Patients 2,4, and 5) had low Euroscore, however, they were notaccepted for conventional AVR because in patient 2conventional AVR was abandoned due to porceline aorta,patient 4 had multiple stroke with dementia, and patients 5had end-stage lung disease.

2.2. Prosthetic valve system

The Cribier—EdwardsTM valve (Edwards Lifesciences Inc.,Irvine, CA) is constructed from a tubular slotted stainless steelstent with an attached equine pericardial trileaflet valve(Fig. 1).A sewn fabric cuff covers the left ventricular portionofthe prosthesis. In-vitro durability of the prosthetic valve hasbeen repeatedly demonstrated to be in excess of 200 million

Table 1Patient characteristics

Characteristic Patient 1 Patient 2 Patient 3

Age (year)/sex 76/F 77/F 76/MBody mass index 22 22 27Hypertension Yes No YesDiabetes Yes No NoLimiting lung disease Yes No NoCAD Yes Yes YesPrior CABG No No YesStroke No No NoAtrial fibrillation No No NoSevere PVD Yes Yes YesGFR* <60 No Yes NoChest radiation No No NoPorcelain aorta Yes Yes NoPulmonary HTN Yes No NoLVEF (%) 35 60 50NYHA class 4 3 2Angina No No NoSyncope No No NoLogistic Euroscore 41 7 66

CAD, coronary artery disease; CABG, coronary artery bypass; PVD, peripheral vascventricular ejection fraction; NYHA, New York Heart Association.

cardiac cycles, corresponding to over 5 years of life. Valves aresupplied sterile in glutaraldehyde. Currently, only 23 and26 mm external diameter prostheses are available fortransapical use. Based on our percutaneous experience, the26 mm prosthesis was considered appropriate for an echo-cardiographic annulus diameter of 20—25 mm.

A mechanical crimping device is utilized to attach theprosthesis onto a specially constructed balloon deploymentcatheter. In these initial apical access cases, we utilized thecatheter delivery system designed for percutaneous femoralarterial access [17]. For the transapical approach, theocclusive fabric skirt must be mounted proximally on theballoon catheter. In this system, the balloon deliverycatheter shaft is contained within a steerable guidingcatheter that can be actively flexed by rotation of anexternal handle.

2.3. Procedure

Patients were premedicated with aspirin, clopidogrel, andvancomycin. Procedures were performed by a team ofcardiac surgeons and cardiologists in an operating roomequipped with fluoroscopy. General anesthesia was utilized.Double lumen intubation was found to be unnecessarybecause lung deflation was not required during theprocedure. We now use single lumen intubation in all cases.The apex of the left ventricle was identified by palpation andfluoroscopy. The pleural space overlying the apex (the fifth orsixth intercostal space) was entered via an approximately5 cm anterolateral mini-thoracotomy. The pericardium overthe apex of the left ventricle was identified and opened.Temporary epicardial ventricular pacing wires were placedon the left ventricle. Reliable capture was assured at a rate ofbetween 160 and 220 beats per minute with a reduction insystemic systolic arterial pressure to below 60 mmHg. Duringvalvuloplasty and prosthesis deployment, rapid pacing wasutilized to minimize transaortic flow and cardiac motion[19,21].

Patient 4 Patient 5 Patient 6 Patient 7

70/M 63/M 90/M 91/M22 26 23 21Yes No Yes NoYes No No NoNo Yes No NoYes Yes Yes YesNo Yes No NoYes No Yes YesYes No Yes NoNo No Yes YesNo No No NoNo Yes No NoNo No No NoNo No Yes Yes50 60 50 402 3 3 3No Yes Yes YesNo No Yes No10 8 57 58

ular disease; GFR, glomerular filtration rate; HTN, hypertension; LVEF, left

J. Ye et al. / European Journal of Cardio-thoracic Surgery 31 (2007) 16—2118

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 avalvuloplasty balloon catheter.

The thin portion of the left ventricular apex was identifiedby finger palpation and confirmed by simultaneous transe-sophageal echocardiographic imaging (TEE). Two pairedorthogonal U-shaped sutures with pledgets were placed intothe myocardium and passed through tensioning tourniquets.Heparin was administered to achieve an activated clottingtime of >250 s. An arterial needle puncture allowedplacement of a 7 French sheath through the apex into theleft ventricular cavity utilizing a standard over the wiretechnique. A wire (0.035 in. J-curve Amplatz extra stiffTM,Cook Inc.) was advanced through the aortic valve, around thearch and into the descending aorta for stability. If necessary aballoon catheter (BermanTM, Cook Inc.) was utilized to directthe wire in the direction of arterial flow past mitral chordaeand around the aortic arch (rarely required). The 7F sheathwas then exchanged for a 14 French sheath. A valvuloplastyballoon (20—22 mm, Z-MedTM, Numed Inc., Hopkington, NY)was advanced over the wire to the level of the ascending

Fig. 2. Positioning of the prosthetic valve was assessed with TEE and aortography anpacing.

aorta, evacuated of air and test inflated with dilutedcontrast. The balloon was withdrawn to the level of thevalve as determined by fluoroscopy and TEE. Rapid pacingwas initiated and when an adequate reduction in systemicarterial pressure was achieved the balloon was rapidlyinflated and deflated [19,21].

The 14 French sheath was exchanged over the wire for a 24French sheath for valvedelivery.Theprosthetic valvemountedon a delivery balloon supported by a steerable catheter wasintroduced through the sheath over the Amplatzer wire. Theprosthetic valve was advanced to the aortic valve and placedat the level of fluoroscopically visible valvular calcium. Aorticroot angiography via a pigtail catheter introduced from thefemoral artery and TEE were used to further aid positioning.When an adequate reduction in systemic arterial pressure wasachievedwith rapid pacing, the prosthetic valvewas deployedusing a rapidmanual inflation/deflation of the delivery balloon(Fig. 2). Following deployment, valve functionwas assessed by

d rapid deployment of the prosthetic valve performed under rapid ventricular

J. Ye et al. / European Journal of Cardio-thoracic Surgery 31 (2007) 16—21 19

Fig. 3. Transesophageal echocardiogram revealed that the tissue valve waswell seated with unrestricted leaflet opening.

Table 2Procedural characteristics

Characteristic N = 7 patients (%)

Aortic annulus diameter (mm) 22.4 � 1.026 mm aortic prosthesis 7 patients 100Valvuloplasty successful 7 patients 100Valve implantation successful 7 patients 100Post-deployment re-dilatation 2 patients 33Procedure time (min) 218 � 18Fluoroscopy time (min) 16 � 4Ventilator time (min) 434 � 283Chest tube removal (days) 2.3 � 2.0Blood loss in 24 h (ml) 286 � 157Blood transfusion 2 patients 29Mortality at 30 days 1 patients 14Median hospital stay (days) (6 patients) a 8 (6,14)b

a Prior to discharge or transfer.b Median (IQR).

TEE (Fig. 3) and angiography. In two of the seven patients,paravalvular insufficiency was excessive and dilatation of theprosthesis was repeated. After removal of the left ventricularsheath, hemostasis was secured with the previously placedpledgeted sutures. The pericardium was approximated topreventmyocardial herniation but allow drainage. A left chesttube was placed [19,21]. Patients were maintained on aspirinindefinitely and clopidogrel for at least 1month. Transthoracicechocardiographywasperformedprior todischargeor transferto another hospital. The authors did not observe anyobstruction of coronary ostia in this cohort of patients afterthe deployment of the tissue valve.

2.4. Follow-up

All patients have been carefully followed by both cardiacsurgeons and cardiologists. Clinical assessment was per-formed by either the patients’ cardiologists or cardiacsurgeons. Follow-up echocardiography was performed at 1and 6 months. We have completed 6-month follow-up in thisinitial cohort of seven patients who underwent minimallyinvasive transapical aortic valve implantation.

2.5. Statistical analysis

Normally distributed data were reported as mean � stan-standard deviation. Non-parametric data were reported asmedian (inter quartile range). No statistical analysis wasperformed due to limited sample size in this series.

3. Results

3.1. Intraoperative results

Transapical aortic valve implantation via a left mini-thoracotomy without CPB was successfully performed in all

seven patients with severe symptomatic aortic stenosis. Allpatients received 26 mm diameter prostheses. Paravalvularregurgitation was moderate by TEE in two patients in whomredilation resulted in further expansion of the prosthesis anda satisfactory reduction in paravalvular regurgitation. At thecompletion of the procedure, aortic insufficiency grade was 1(1,2) by TTE. There was no obstruction of coronary ostia inthis cohort of patients and no intraoperative complications ormortality. We did not experience any hemostatic problems inclosing the puncture site of the left ventricular apex. Allpatients tolerated the procedure very well. Proceduralcharacteristics are shown in Table 2.

3.2. Clinical follow-up

Of the first seven patients, five patients were dischargedhome and one transferred to another hospital for convales-cent care. The 7th patient, who had a predicted surgicalmortality of 58% based on the logistic Euroscore, died at day12 due to pneumonia. The median hospital stay prior todischarge or transfer was 8 (6,14) days. The delayed hospitaldischarge was mainly due to preoperatively comorbidities.There were no significant postoperative complications,except pleural effusion requiring tube drainage in onepatient, and lower urinary tract infection in another patient.At 1- and 6-month follow-up, preoperative symptoms relatedto severe aortic stenosis were either resolved or significantlyimproved. Postoperative NYHA class remained unchanged inonly one patient who had end-stage lung disease that existedpreoperatively. This patient died from his end-stage lungdisease at postoperative day 51. Another patient died fromcancer at day 85. The other four patients continue to do wellwith significantly improved quality of life.

3.3. Echocardiographic follow-up

Echocardiography was performed prior to hospital dis-charge (seven patients), and at 1 month (six patients) and 6month (four patients). Echocardiography performed prior tohospital discharge demonstrated (1) well-seated aorticvalves with normal valve function in all seven patients, (2)moderate paravalvular regurgitation in one patient, mildparavalvular regurgitation in two patients, and non or trivial

J. Ye et al. / European Journal of Cardio-thoracic Surgery 31 (2007) 16—2120

Table 3Echo characteristics

Echo parameter Pre procedure, N = 7 Post procedure N = 7 1 month, N = 6 6 months, N = 4

Aortic valve area 0.7 � 0.3 1.6 � 0.6 1.8 � 0.7a 1.5 � 0.5Aortic mean gradient 32 � 8 10 � 7 10 � 5 11 � 8Ejection fraction 49% � 9% 52% � 13% 54% � 8% 60% � 9%Aortic regurgitationb [Grade:1—4]c 1 (1,2) 1 (1,2) 2 (1,2) 1 (0,2)Mitral regurgitationb [Grade: 1—4]c 3 (2,3) 2 (1,4) 2 (1,2) 2 (1,2)

a Unable to calculate in three patients.b Regurgitation reported: median (IQR).c Regurgitation was graded as 1:trivial; 2:mild; 3:moderate; 4:severe.

paravalvular regurgitation in four patients, (3) aortic valvearea of 1.6 � 0.6 cm2, and (4) mean transaortic gradient of10 � 7 mmHg. These measurements were maintained at 1-and 6-month follow-up (Table 3). In no patient didparavalvular insufficiency appear clinically significant.Decreases in mitral regurgitation were observed at 1- and6-month echocardiographic follow-up (Table 3). LV functionshows an improving trend at 6-month follow-up (Table 3).

4. Discussion

Aortic valve replacement is the treatment of choice inpatients with severe symptomatic acquired aortic stenosis,offering both symptomatic relief and the potential ofimproved long-term survival [1]. Symptomatic patientsmanaged medically have a poor prognosis [2—4]. Balloonvalvuloplasty is palliative and although it may result intemporary relief of symptoms, benefit is modest andrestenosis certain [6,23].

Unfortunately, many potential surgical candidates havesignificant co-morbid conditions and open-heart surgery withCPB may pose risks that are unacceptable to them or theirphysicians. According to the Society of Thoracic SurgeryDatabase (1998—2001) surgical aortic valve replacementcarries a rate of serious complication or mortality of 16.8%.Operative risk is increased in the setting of co-morbidconditions including advanced age [24,25]. Our patients werejudged poor candidates for routine surgery with an estimatedlogistic Euroscore operative mortality of 31 � 23%. Theobserved 30-day mortality of 14% is encouraging.

The feasibility of percutaneous valve implantation wasfirst demonstrated in an animal model by Anderson et al. [7].Subsequently several groups, including our own, pursued thedevelopment of percutaneous heart valves [7—13]. Percuta-neous aortic valve implantation in humans was firstperformed as a transvenous transseptal procedure withantegrade access to the aortic valve by Cribier et al. [14,15].However, the technical complexity and associated risks withthis procedure appear likely to limit its widespreadapplication.

Authors reported the development of a transarterialretrograde technique with which initial results have beenfavorable [17,18]. Evaluation of this procedure is ongoing andremains encouraging. Although the transfemoral arterialprocedure has proven successful, some patients are poorlysuited to this approach due to femoral, iliac or aortic size,tortuosity, aneurysm, atheroma, or dissection. This has led tothe further development of an alterative approach via the

left ventricular apex for aortic valve implantation, which isindependent of central and/or peripheral arterial size,anatomy, or diseases. Our initial percutaneous valve devel-opment had utilized direct balloon catheter implantationfrom the left ventricular apex in a porcine model [12].Subsequently, we reported the first successful case of aorticvalve implantation via a left mini-thoracotomy and the leftventricular apex without CPB in human [19] and our initialexperience in this approach [21].

Valvuloplasty data suggests that stroke is a surprisinglyinfrequent occurrence despite heavy aortic valve calcifica-tion [6,23]. It is likely that the calcific debris familiar tosurgeons replacing the aortic valve results from violation ofthe aortic valve endothelium when resecting the valve. If thiscovering is kept intact during valvuloplasty and valvedeployment, embolization does not occur despite displace-ment or even crumbling of the calcium within this covering.Coronary obstruction or stroke could conceivably occur dueto embolization of friable valvular debris, although this hasnot been observed with percutaneous valve implantation[17]. In this initial series of seven patients, aorticvalvuloplasty and deployment of the aortic prostheses werenot associated with stroke or coronary obstruction. Deviceembolization was an unpredictable concern during earlypercutaneous experience. However, with accurate position-ing, sizing, and deployment techniques, prosthesis emboliza-tion appears to be rare as reflected in this initial apical accessexperience. Furthermore, the inappropriate positioning ofprosthesis may be less frequent using the left ventricularapex approach given the nature of its antegrade approachand very short distance to reach the valve.

The transapical transcatheter approach to aortic valveimplantation is safe and reliable with minimal operative risksand good early outcome as reflected in this series. Thepostoperative recovery, length of hospital stay, and latesurvival are dependent on preoperative comorbidities. Thisminimally invasive aortic valve implantation appears to be anacceptable approach to symptomatic aortic stenosis inpatients who are deemed to be non-surgical candidates.The procedure provides immediate relief of AS-relatedsymptoms and significantly improves quality of life.

Trivial to mild paravalvular regurgitation appears to becommon immediately after successful deployment of pros-thesis. However, no worsening of the paravalvular regurgita-tion was observed during the 6-month follow-up, and in nopatient did the residual paravalvular leak appear clinicallysignificant in this series. Significant prosthetic regurgitationwas not observed in any patients, and aortic valvular area andtransvalvular gradient were stable during 6-month follow-up.

J. Ye et al. / European Journal of Cardio-thoracic Surgery 31 (2007) 16—21 21

In summary, aortic valve implantation is feasible via aminimally invasive apical approach without the need forcardiopulmonary bypass. The early results in the initial seriesare favorable. This initial experience suggests minimallyinvasive transapical approach is a new, viable alternative forpatients in whom open-heart surgery is not feasible or posesunacceptable 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):1105—10.

[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/Amer-ican Heart Association Task Force on Practice Guidelines (Committee onManagement of Patients with Valvular Heart Disease). J Am Coll Cardiol1998;32:486—588.

[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 afterballoon aortic valvuloplasty: insights into prognosis of valvular aorticstenosis. Circulation 1994;89:642—50.

[5] Lieberman EB, Bashore TM, Hermiller JB, Wilson JS, Pieper KS, Keeler GP,Pierce CH, Kisslo KB, Harrison JK, Davidson CJ. Balloon aortic valvulo-plasty in adults: failure of procedure to improve long-term survival. J AmColl Cardiol 1995;26:1522—8.

[6] Feldman T. Core curriculum for interventional cardiology: percutaneousvalvuloplasty. Catheter Cardiovasc Interv 2003;60:48—56.

[7] Andersen HR, Knudsen LL, Hasenkam JM. Transluminal implantation ofartificial heart valves. Description of a new expandable aortic valve andinitial results with implantation by catheter technique in closed chestpigs. Eur Heart J 1992;13:704—8.

[8] Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Der-umeaux G, Anselme F, Laborde FMBL. Trans-catheter implantation ofballoon-expandable prosthetic heart valves, early results in an animalmodel. Circulation 2001;104(Suppl 2):I552.

[9] Boudjemline Y, Bonhoeffer P. Steps toward percutaneous aortic valvereplacement. Circulation 2002;105:775—8.

[10] Boudjemline Y, Bonhoeffer P. Percutaneous implantation of a valve in thedescending aorta in lambs. Eur Heart J 2002;23:1045—9.

[11] Boudjemline Y, Bonhoeffer P. Steps toward percutaneous aortic valvereplacement. Circulation 2002;105(6):775—8.

[12] Webb JG, Munt B, Makkar R, Naqvi T, Dang N. A percutaneous stent-mounted valve for treatment of aortic or pulmonary valve disease. CathetCardiovasc Interv 2004;63:89—93.

[13] Grube E, Laborde JC, Zickmann B, Gerckens U, Felderhoff T, Sauren B,Bootsveld A, Buellesfeld L, Iversen S. First report on a human percuta-neous transluminal implantation of a self-expanding valve prosthesis forinterventional treatment of aortic valve stenosis. Catheter CardiovascInterv 2005;66:465—9.

[14] Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Der-umeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheterimplantation of an aortic valve prosthesis for calcific aortic stenosis.Circulation 2002;106:3006—8.

[15] Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Sebagh L, Bash A,Nusimovici D, Litzler PY, Bessou JP, Leon MR. Early experience withpercutaneous transcatheter implantation of heart valve prosthesis forthe treatment of end-stage inoperable patients with calcific aorticstenosis. J Am Coll Cardiol 2004;43:698—703.

[16] Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Nercolini D, TapieroS, Litzler P, Bessou J, Babaliaros V. Treatment of calcific aortic stenosiswith the percutaneous heart valve. Mid-term follow-up from the initialfeasibility studies: the French experience. J Am Coll Cardiol2006;47:1214—23.

[17] Webb JG, Chandavimol M, Thompson C, Ricci DR, Carere R, Munt B, BullerCE, Pasupati S, Lichtenstein S. Percutaneous aortic valve implantationretrograde from the femoral artery. Circulation 2006;113:842—50.

[18] Chandavimol M, McClure SJ, Carere R, Thompson CR, Ricci DR, MacKay M,Webb JG. Percutaneous aortic valve implantation: a case report. Can JCardiol. 2006, [in press].

[19] Ye J, Cheung A, Lichtenstein SV, Carere RG, Thompson CR, Pasupati S,Webb JG. Transapical aortic valve implantation in man. J Thorac Cardi-ovasc Surg 2006;131:1194—6.

[20] Lichtenstein SV. Closed heart surgery. Back to the future. J ThoracCardiovasc Surg 2006;113.

[21] Lichtenstein SV, Cheung A, Ye J, Thompson CR, Carere RG, Pasupati S,Webb JG. Transapical Transcatheter aortic valve implantation in humans.initial clinical experience. Circulation 2006;114:591—6.

[22] Nashef SA, Roques F, Hammill BG, Peterson ED, Michel P, Grover FL, WyseRK, Ferguson T. Validation of european system for cardiac operative riskevaluation (EuroSCORE) in North American cardiac surgery. Eur J Cardi-othorac Surg 2002;22(1):101—5.

[23] O’Neill WW. Predictors of long-term survival after percutaneous aorticvalvuloplasty: report of the Mansfield Scientific Balloon Aortic Valvulo-plasty Registry. J Am Coll Cardiol 1991;17(1):193—8.

[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 atthe age of >80 years. Circulation 2000;102(19 Suppl 3):III70—4.

[25] Mullany CJ. Aortic valve surgery in the elderly. Cardiol Rev 2000;8:333—9.

Appendix A. Conference discussion

Dr O. Oto (Izmir, Turkey): As I had presented at the ESC meeting inBarcelona this year, this incision can be done over the aorta easily with just5 cm of incision, and minimally invasive aortic valve replacement can be easilydone 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 routineconventional surgical armamentarium so that we can perform it on any casewith any kind of valve?

Dr Ye: You mentioned minimally invasive aortic valve replacement. Ibelieve that to do the aortic valve replacement you still need usecardiopulmonary bypass, right? You still need cardiopulmonary bypass duringthe minimally invasive procedure. For this procedure basically you don’t needany cannulation or bypass equipment. Our patients were sick with very highoperative risk. In some patients predicted mortality was 50 or 60%. And Ibelieve if you don’t use cardiopulmonary bypass, perioperative mortality andmorbidity would be significantly reduced. This approach without use ofcardiopulmonary bypass system would be safer for the very elderly person orsick patient.

Dr H. Alsisi (Cairo, Egypt): First, do you have any way to measure thedegree of calcification that in some cases you will not be able to dilate theaortic valve before inserting this valve through the apex of the heart and therisks of emboli from the calcific lesions when you extend the balloon andcomment about the paravalvular leak, or any failure? Did you have any failureto dilate the aortic valve, and what do you do if there is severe aortic regurgand you should not inflate the valve at this time?

Dr Ye: I have not had this kind of situation so far. For a severely calcifiedaortic valve, there is a possibility of having difficulty to dilate the valve. In ourseries we haven’t seen this kind of problem.

Dr Alsisi: What is the backup strategy if something happens like this? Youwill have the bypass ready to go immediately on bypass, or what do you dopreoperatively if this situation would happen? It is not in the mind that thismight happen?

Dr Ye: I guess there is a possibility, but actually I haven’t had thisexperience. I just want to emphasize that this procedure is only for acompassionate use in our patient group. So basically the patient would not be asurgical candidate. We already discussed it with the patient before theprocedure. All the patients were assessed by two cardiologists and two cardiacsurgeons independently to determine if the patient was a surgical candidate ornot. If there is anyone who is a surgical candidate, wewill not proceedwith thisprocedure. Before the procedure the patients were told that if any disasterhappened, wewould not going to put them on the pump. That is why there is nocardiopulmonary bypass pump in OR.