Impact of Aortic Valve Design, component materials and manufacturing processes on valve performance for pericardial tissue valves

History and FutureofAortic Valve ImplantationOTTAVIO ALFIERIS.Raffaele University HospitalMilanoAetiologies of Single Valvular Heart Diseases in the Euro Heart Survey

(Iung. Eur Heart J 2003;24:1244-53)43% 13% 32% 12%

AS is the most frequent native vhdAortic Stenosis: SurvivalNEJM 1997;337;32-41 and UK Heart Valve RegistryYears% Survival31545% alive97.2% aliveOnset of symptomsSurgeryFailureSyncopeAngina3The natural history of AS is well definedAge(years) 70 years(%) 1 comorbidity(%)AS6912 5636AR5816 2526MS5813 1822MR6514 4442Patient Characteristics in the Euro Heart Survey(Iung. Eur Heart J 2003;24:1244-53)

pts with AS and are often old with comorbidities Surgical Risk vs. BenefitPoor value:PatientPurchaserPhysicianOptimumValueSurgical RiskClinical BenefitLimitedValueIncreasing age?5With inccreasing age the surgical risk is also increasing tto the point that there is no more clinica benefit

22 centres, 67,764 patients, 4,743 octogenarians

Central Cardiac Audit Database, UK6Survival after Isolated Aortic Surgeryin patients aged 80+: Influence of pulmonary diseaseNo lung diseaseCOPD/emphysema/asthmaDischarge96.7%75.7%1 year90.6%69.6%2 years88.9%54.9%5 years63.6%20.0%Central Cardiac Audit Database, UK7The effect of comorbidities on results is strikingSurvival after Isolated Aortic Surgery in patients aged 80+: Influence of peripheral vascular diseaseNo PVDPVDDischarge96.0%79.6%1 year90.2%68.2%2 years88.3%52.3%5 years57.8%28.5%Central Cardiac Audit Database, UK8

One third of patients did not undergo surgery because of age, comorbidities or LV dysfunctionNot surprisingly.In Europe, an estimated 32% of patients with valvular heart disease are not being operated because of concomitant medical illnesses that makes them high risk Severe AS : Valve Area 0.6 cm/m BSA or Mean Gradient 50 mmHgSymptomatic AS : NYHA Class III or IV or AnginaAortic Stenosis 75 yearsN=408No Severe AS(n=114)Severe AS(n=284)No SymptomsN=68SymptomsN=216InterventionN=144 (67%)No InterventionN=72 (33%)NYHA III :106NYHA IV : 36Angina : 148Severe symptomatic AS (Iung. Eur Heart J 2005;26:2714-20)Many pts with AS are not referred to surgeryAt least 30-40% of Cardiologists AS Patients Go Untreated

Severe Symptomatic Aortic StenosisPercent of Cardiology Patients TreatedBouma B J et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart 1999;82:143-148Iung B et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. European Heart Journal2003;24:1231-1243 (*includes both Aortic Stenosis and Mitral Regurgitation patients)Pellikka, Sarano et al. Outcome of 622 Adults with Asymptomatic, Hemodynamically Significant Aortic Stenosis During Prolonged Follow-Up. Circulation 2005Charlson E et Decision-making and outcomes in severe symptomatic aortic stenosis al.. J Heart Valve Dis2006;15:312-321No AVRAVRUnder-treatment especially prevalent among patients managed by Primary Care physicians111111The information produced by the euro heart survey is also provided and replicated by other studiesAortic Valve ImplantationThe Evolving ProcessConventional midline sternotomySurgical through Minimal IncisionOn pump, arrested heart sutureless valve replacementTransaortic, beating heart deliveryTransapical deliveryPercutaneous - antegrade or retrogradeInvasiveness

For all the above(what I said up to now) tretment of AS has been evolving over time: In term of invasiveness the real breakthrough is the transcatheter treatment of aortic stenosis without arresting the heart and without using ECCF.I.M. Balloon Aortic Valvuloplasty19850100200First attempt of treating non surgical AS patientsThousand of cases performed worldwide Hemodynamic / symptomatic improvement No effect on patients survivalONE MAIN LIMITATION Early valve restenosis: 80% at one yearBAV

THE LANCET, JANUARY 11, 1986

F.I.M.: 20mm BalloonSept 1985Transcatheter treatment of aortic stenosis started more than 20 years ago with the FIM ballon valvuloplasty..

Observational Study in Cadavers Hearts- PHV Implantation/Retention Force, February 24, 2002. THE GOAL.14Since the very beginning then was evident that the goal should be not the dilatation of the aortiv valve but the implantation of a new valv in ortthotopic position F.I.M. Balloon Aortic Valvuloplasty1985Concept ofstented valve, to rule out post-BAV valvular restenosis19871989First animal implantation (balloon exp) in pigPost mortem studies of intra-valvular stentingPercutaneous Valve Technology (prototypes)1999First animal implantation(self exp)2000Large series of animal implantation2000-02F.I.M. PHV implantation2002Feasibility Studies (antegrade)2002-03First in Man Corevalve 25 F2004International TF Feasibility Studies2005-07CE mark commercialization200720 years15In a bit more than 20 years fror first bav to ce mark and commercialization.In this slide important historical contribution in this process are indicated Ce mark was obtained after several feasibility studiesThe pioneersHenning Andersen (May 1st 1989)First successful pig implant Granted with 2 patentsAlain Cribier (April 16, 2002)Parallel research and proof of conceptImplanted first percutaneous aortic valve on a patient via an antegrade approach

16Add comments regarding proctor statusSolution:Combined schedule of all proctoring/training events

8 days post-implantationF.I.M Alain Cribier 2002F.I.M. and Feasibility Studiespre CE approvalRESULTSProcedural success about 90%Mortality at 30 days ranges from 5 to 18%Acute myocardial infarction in 2 to 11%Severe AR in about 5%Vascular complications in 10 to 15%Stroke in 3 to 9%AV bock in 4 to 20%Survival :70 to 80% at 2 y.In the process to obtain the CE mark data from a number of fim and feasibility studies were determinant and these are the data

Edwards SAPIENCore ValveCE-MARKED DEVICES

(Transfemoral / Transaxillary)(Transfemoral / Transapical)Generation 125FrEndovascularGeneration 221FrEndovascularGeneration 318FrPercutaneous14 patients65 patients>3000 patients 2004-20052005-2006May 2006*CoreValve evolutionAfter the commercialization some modifications took place to facilitate the procedure and to improve results The caliber of the introdicing sheat General anesthesiaSurgical cutdown/repairVentricular assistanceDec. 2006Nov. 2006

Pre-closing with ProStar Local Anesthesia Beating heart Valve delivery without rapid pacing No cardiac assistance18 French Procedural ProgressEvolution to a real cath lab procedurewithin the first 40 Patients of 18 Fr study Oct. 2006And as a matter of fact the procedure became simpler as demonstrated here

Developments and Improvments

UntreatedEquine TissueCribier-Edwards THV23mmEdwards SAPIEN THV23mm, 26mmTreatedBovine TissueDurabilityHeamodynamic Performance Profile Ease of Use

Edwards SAPIEN THV II23mm, 26mmLow profileCobalt-chrome

Ascendra Introducer Sheath 26Fr.RetroFlex IIEdwards SAPIEN2222Developments and improvments occurred also in the Edwards deviceRETROFLEX DELIVERY SYSTEM

Stainless Steel Braid BETTER TORQUEFront end rotational grip SINGLE HANDED ARTICULATIONEdwards SAPIEN evolution23Changes were also introduced in the delivery system particularly with the active and precious contribution of Jhon Webb

Soon after the ce mark approval and then commercialization.the professional societes (both) considered quite appropriate to create a joint task force to produce a document.. To function as guideline. To help in establishing a clinical practice in this emerging field: and this document is still valid in many aspects although we all know that this document can only be of temporary value due to its natureTAVI is reserved to pts. withsevere AS and symptoms whoare inoperable or at high riskfor surgery

INDICATIONThis is still valid although new indications will be emerging in a little whileSTEPS OF PTS. SELECTION-Confirmation of severity of AS-Evaluation of symptoms-QoL-Analysis of surgical risk-Evaluation of life expectancy-Assessment of feasibility and exlusion of contraindications Also the steps in pts selection are still valid and would like briefly to review them for youGradients and Valve Area ECHO TT and TEEHemodynamicsCTMRIDobutamine testingSeverity of aortic stenosis

Severity of aortic stenosis has to be well assessed by measurements of gradients27Aortic valve area assessmentMDCT vs MRI vs TEE vs TTEPouleur AC , et al, Radiology, 2007;244: 745-754

MDCT MRI TEE

Severity of aortic stenosis should also be assessed measuring the area . One of the different methods is enough since there is a good correlation among the various methods28Analysis of surgical riskLogistic Euroscore > 20STS Score > 10 (new M & M)

ParsonnetAmbler

Mini Nutritional Assesment (Geriatric Version)

Analysis of the surgical risk is an other important step. Using scores is important but the final decision should be based on clinical evaluation. As a matter of fact many important factors are not included in the EURO score or STS score as porcelaine aorta previous operation previous radiation liver cyrrosis etc. and frailty because every pt. is different29Contraindicatios (general)Aortic annulus (too small or to large)Bicuspid valve ( ? )Asymmetric heavy valvular calcificationAortic root dilatation (for self-expandable)Presence of LV thrombus

General contraindications are still valid.Annular measurements

TT= 20error survivalerror survivalMonths post ProcedureSurvivalSource All Cause Mortality -- Transfemoral ApproachStratified by Logistic EuroSCORE(April 30, 2009 Data)

TF Vasc KM Graph1110.9898000.005050.0050510.98980.93860.87930.01880.01880.01650.016510.98980.86910.81470.03250.03250.02170.021710.98980.85240.76390.03590.03590.02680.02680.9940.97710.78060.74740.05170.05170.02870.02870.9940.97710.71790.71690.06380.06380.03250.03250.9940.97710.71790.69480.06380.06380.0350.0350.9820.96690.71790.69480.06380.06380.0350.0350.9820.96690.65270.69480.08510.08510.0350.0350.96990.96440.65270.67650.08510.08510.03860.03860.96990.96440.65270.65540.08510.08510.04280.04280.95790.95420.57110.65540.10660.10660.04280.04280.95790.95420.57110.62090.10660.10660.05260.05260.95790.95420.62090.05260.05260.95790.94660.95790.94660.95790.94660.95790.93890.95790.93890.95790.93890.95170.93380.95170.93380.95170.93380.95170.92610.95170.92610.95170.92610.95170.92090.95170.92090.95170.92090.95170.91840.95170.91840.95170.91840.95170.91580.95170.91580.95170.9080.95170.9080.95170.9080.95170.90540.95170.90540.95170.90020.95170.90020.95170.89760.95170.89760.95170.8950.95170.8950.95170.88980.95170.88980.95170.88980.95170.88460.95170.88460.95170.88460.95170.8820.95170.8820.95170.8820.94520.8820.94520.8820.94520.8820.94520.8820.93860.8820.93860.8820.93860.8820.93860.87930.93860.87930.93860.87930.93860.87930.93860.87930.93860.87930.93860.87930.93860.87930.93860.87930.93860.87090.93860.87090.93860.87090.93860.87090.93860.87090.93860.87090.93860.86770.93860.86770.93860.86770.93860.86440.93860.86440.93860.86440.92850.86440.92850.86440.92850.86440.92850.86110.92850.86110.92850.86110.92850.86110.92850.85760.92850.85760.92850.85760.92850.85760.92850.850.92850.850.92850.850.89490.84610.89490.84610.89490.84610.89490.8420.89490.8420.89490.8420.89490.83790.89490.83790.89490.83790.89490.83370.89490.83370.89490.83370.89490.83370.89490.82920.89490.82920.89490.82920.89490.82920.89490.82920.89490.82920.89490.82440.89490.82440.89490.82440.89490.81950.89490.81950.89490.81950.88250.81470.88250.81470.88250.81470.88250.81470.88250.81470.88250.81470.88250.81470.86910.81470.86910.81470.86910.81470.86910.81470.86910.81470.86910.81470.86910.81470.86910.81470.86910.8090.86910.8090.86910.8090.86910.8090.86910.8090.86910.8090.86910.8030.86910.8030.86910.8030.86910.8030.86910.8030.86910.8030.86910.8030.86910.8030.85240.8030.85240.8030.85240.8030.85240.79030.85240.79030.85240.78390.85240.78390.85240.78390.85240.78390.85240.78390.85240.77740.85240.77740.85240.77740.85240.77080.85240.77080.85240.77080.85240.77080.85240.77080.85240.77080.85240.76390.85240.76390.85240.76390.85240.76390.85240.76390.85240.76390.85240.76390.85240.76390.85240.76390.85240.76390.85240.75630.85240.75630.83060.75630.83060.75630.83060.75630.83060.75630.80750.75630.80750.75630.80750.75630.80750.75630.80750.75630.80750.75630.80750.75630.80750.75630.80750.75630.78060.75630.78060.75630.78060.75630.78060.74740.78060.74740.78060.74740.78060.74740.78060.74740.78060.74740.78060.74740.78060.74740.78060.74740.75060.74740.75060.74740.75060.74740.75060.74740.75060.74740.75060.74740.75060.73760.75060.73760.71790.72770.71790.72770.71790.72770.71790.72770.71790.72770.71790.72770.71790.72770.71790.71690.71790.71690.71790.71690.71790.71690.71790.71690.71790.71690.71790.70580.71790.70580.71790.70580.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.71790.69480.65270.69480.65270.69480.65270.69480.65270.69480.65270.67650.65270.67650.65270.67650.65270.67650.65270.67650.65270.67650.65270.67650.65270.67650.65270.65540.65270.65540.65270.65540.65270.65540.65270.65540.65270.65540.65270.65540.65270.65540.65270.65540.65270.65540.65270.65540.65270.65540.57110.65540.57110.65540.57110.65540.57110.65540.57110.65540.57110.65540.57110.62090.57110.62090.57110.62090.57110.62090.57110.62090.57110.62090.57110.62090.57110.62090.57110.62090.57110.62090.57110.62090.57110.62090.57110.62090.57110.62090.57110.62090.57110.62090.57110.62090.57110.62090.57110.62090.57110.62090.57110.62090.57110.62090.57110.6209

Error bars at 1 se (Greenwood)< 20>= 20error survivalerror survivalMonths post ProcedureSurvivalSource All Cause Mortality -- Transapical ApproachStratified by Logistic EuroSCORE(April 30, 2009 Data)

TA Vasc KM Graph110.99010.98640.005690.005690.009550.009550.99010.98640.95910.91470.01160.01160.02360.02360.99010.98640.91480.85970.01840.01840.03270.03270.99010.98640.88820.84220.02340.02340.03650.03650.98350.97260.8760.82210.0260.0260.04070.04070.98350.97260.82880.82210.03620.03620.04070.04070.98350.97260.82880.82210.03620.03620.04070.04070.98010.96570.82880.79170.03620.03620.04930.04930.98010.96570.82880.79170.03620.03620.04930.04930.98010.95870.82880.79170.03620.03620.04930.04930.98010.95870.82880.750.03620.03620.06190.06190.98010.95870.79810.750.04610.04610.06190.06190.97680.95870.79810.750.04610.04610.06190.06190.97680.95870.65620.10310.10310.97680.95870.97680.95870.97680.95870.97680.95870.97680.95870.97330.95870.97330.95870.97330.95870.97330.94430.97330.94430.97330.94430.97330.94430.97330.9370.97330.9370.96980.9370.96980.9370.96980.9370.96980.9370.96980.92960.96980.92960.96980.92960.96630.92960.96630.92960.96630.92960.96630.92960.96270.92960.96270.92960.96270.92960.96270.92230.96270.92230.96270.92230.96270.92230.96270.92230.96270.92230.95910.92230.95910.92230.95910.92230.95910.91470.95910.91470.95910.91470.95910.91470.95910.91470.95910.91470.95910.91470.94660.91470.94660.91470.94660.91470.94230.91470.94230.91470.94230.91470.94230.9060.94230.9060.94230.9060.93780.9060.93780.9060.93780.9060.93780.9060.93780.9060.93780.89550.93780.89550.93780.89550.93780.89550.93280.89550.93280.89550.93280.89550.93280.88430.93280.88430.93280.88430.93280.88430.93280.88430.93280.88430.92750.8720.92750.8720.92750.8720.92750.85970.92750.85970.92750.85970.92750.85970.92750.85970.92160.85970.92160.85970.92160.85970.92160.85970.92160.85970.92160.85970.92160.85970.92160.85970.92160.85970.92160.85970.91480.85970.91480.85970.91480.85970.91480.85970.91480.85970.91480.85970.91480.85970.91480.85970.91480.85970.91480.85970.91480.85970.91480.85970.91480.85970.91480.85970.91480.85970.91480.85970.91480.85970.91480.85970.90610.85970.90610.85970.90610.85970.90610.85970.89730.85970.89730.85970.89730.85970.89730.85970.89730.85970.88820.85970.88820.85970.88820.85970.88820.85970.88820.85970.88820.84220.88820.84220.88820.84220.88820.84220.88820.84220.88820.84220.88820.84220.88820.84220.88820.84220.88820.84220.88820.84220.88820.84220.88820.84220.88820.84220.88820.84220.8760.82210.8760.82210.8760.82210.8760.82210.8760.82210.8760.82210.8760.82210.8760.82210.8760.82210.8760.82210.8760.82210.8760.82210.8760.82210.8760.82210.8760.82210.8760.82210.86070.82210.86070.82210.86070.82210.86070.82210.8450.82210.8450.82210.8450.82210.8450.82210.8450.82210.82880.82210.82880.82210.82880.82210.82880.82210.82880.82210.82880.82210.82880.82210.82880.82210.82880.82210.82880.82210.82880.82210.82880.82210.82880.82210.82880.82210.82880.82210.82880.82210.82880.82210.82880.82210.82880.82210.82880.82210.82880.82210.82880.82210.82880.79170.82880.79170.82880.79170.82880.79170.82880.79170.82880.79170.82880.79170.82880.79170.82880.79170.82880.79170.82880.79170.82880.79170.82880.79170.82880.79170.82880.79170.82880.79170.82880.79170.82880.79170.82880.79170.82880.79170.82880.79170.82880.79170.82880.750.82880.750.82880.750.79810.750.79810.750.79810.750.79810.750.79810.750.79810.750.79810.750.79810.750.79810.750.79810.750.79810.750.79810.750.79810.750.79810.750.79810.750.79810.750.79810.750.79810.750.79810.750.79810.750.79810.65620.79810.65620.79810.65620.79810.65620.79810.65620.79810.65620.79810.65620.79810.65620.79810.65620.79810.65620.79810.65620.79810.65620.79810.65620.79810.65620.79810.65620.79810.65620.79810.65620.79810.65620.79810.65620.79810.65620.79810.6562

Error bars at 1 se (Greenwood)< 30>= 30error survivalerror survivalMonths post ProcedureSurvivalSource All Cause Mortality -- Transfemoral ApproachStratified by Logistic EuroSCORE(April 30, 2009 Data)

TA Vasc at Risk110.985510.005860.00586000.985510.94250.95450.01160.01160.03140.03140.985510.90660.8390.01590.01590.06120.06120.985510.88620.80250.01940.01940.06850.06850.97820.97730.86880.80250.02260.02260.06850.06850.97820.97730.84790.72960.02650.02650.09340.09340.97820.97730.84790.72960.02650.02650.09340.09340.97580.95450.83370.72960.02960.02960.09340.09340.97580.95450.83370.72960.02960.02960.09340.09340.97340.95450.83370.72960.02960.02960.09340.09340.97340.95450.81340.72960.03510.03510.09340.09340.97340.95450.79310.72960.03970.03970.09340.09340.97090.95450.79310.72960.03970.03970.09340.09340.97090.95450.72960.09340.09340.97090.95450.97090.95450.97090.95450.97090.95450.97090.95450.96840.95450.96840.95450.96840.95450.96330.95450.96330.95450.96330.95450.96330.95450.96070.95450.96070.95450.95820.95450.95820.95450.95820.95450.95820.95450.95560.95450.95560.95450.95560.95450.9530.95450.9530.95450.9530.95450.9530.95450.95040.95450.95040.95450.95040.95450.94780.95450.94780.95450.94780.95450.94780.95450.94780.95450.94780.95450.94520.95450.94520.95450.94520.95450.94250.95450.94250.95450.94250.95450.94250.95450.94250.95450.94250.95450.94250.95450.93350.95450.93350.95450.93350.95450.93040.95450.93040.95450.93040.95450.92730.95450.92730.95450.92730.95450.92730.9280.92730.9280.92730.9280.92730.9280.92730.9280.92730.90070.92730.90070.92730.90070.92730.90070.92340.90070.92340.90070.92340.90070.91950.90070.91950.90070.91950.90070.91950.90070.91950.90070.91950.90070.91530.87260.91530.87260.91530.87260.91110.87260.91110.87260.91110.87260.91110.87260.91110.87260.90660.87260.90660.87260.90660.87260.90660.87260.90660.87260.90660.87260.90660.87260.90660.87260.90660.87260.90660.87260.90660.8390.90660.8390.90660.8390.90660.8390.90660.8390.90660.8390.90660.8390.90660.8390.90660.8390.90660.8390.90660.8390.90660.8390.90660.8390.90660.8390.90660.8390.90660.8390.90660.8390.90660.8390.90660.80250.90660.80250.90660.80250.90660.80250.90.80250.90.80250.90.80250.90.80250.90.80250.89320.80250.89320.80250.89320.80250.89320.80250.89320.80250.88620.80250.88620.80250.88620.80250.88620.80250.88620.80250.88620.80250.88620.80250.88620.80250.88620.80250.88620.80250.88620.80250.88620.80250.88620.80250.88620.80250.88620.80250.86880.80250.86880.80250.86880.80250.86880.80250.86880.80250.86880.80250.86880.80250.86880.80250.86880.80250.86880.80250.86880.80250.86880.80250.86880.80250.86880.80250.86880.80250.86880.80250.85860.80250.85860.80250.85860.80250.85860.80250.85860.72960.85860.72960.85860.72960.85860.72960.85860.72960.84790.72960.84790.72960.84790.72960.84790.72960.84790.72960.84790.72960.84790.72960.84790.72960.84790.72960.84790.72960.84790.72960.84790.72960.84790.72960.84790.72960.84790.72960.84790.72960.84790.72960.84790.72960.84790.72960.84790.72960.84790.72960.84790.72960.84790.72960.83370.72960.83370.72960.83370.72960.83370.72960.83370.72960.83370.72960.83370.72960.83370.72960.83370.72960.83370.72960.83370.72960.83370.72960.83370.72960.83370.72960.83370.72960.83370.72960.83370.72960.83370.72960.83370.72960.83370.72960.83370.72960.83370.72960.81340.72960.81340.72960.81340.72960.79310.72960.79310.72960.79310.72960.79310.72960.79310.72960.79310.72960.79310.72960.79310.72960.79310.72960.79310.72960.79310.72960.79310.72960.79310.72960.79310.72960.79310.72960.79310.72960.79310.72960.79310.72960.79310.72960.79310.72960.75340.72960.75340.72960.75340.72960.75340.72960.75340.72960.75340.72960.75340.72960.75340.72960.75340.72960.75340.72960.75340.72960.75340.72960.75340.72960.75340.72960.75340.72960.75340.72960.75340.72960.75340.72960.75340.72960.75340.72960.75340.72960.75340.72960.75340.7296

Error bars at 1 se (Greenwood)NoYeserror survivalerror survivalMonths post ProcedureSurvivalSource All Cause Mortality -- Transfemoral ApproachStratified by Major Vascular Complication(May 1, 2009 Data)

TA Vasc KM Data110.99460.91670.003090.003090.07980.07980.99460.91670.89990.750.01280.01280.1250.1250.99460.91670.8340.750.01790.01790.1250.1250.99460.91670.79270.750.02170.02170.1250.1250.98390.91670.76130.750.0250.0250.1250.1250.98390.91670.72250.750.02920.02920.1250.1250.98390.91670.70470.750.0310.0310.1250.1250.97310.91670.70470.750.0310.0310.1250.1250.97310.91670.690.750.03370.03370.1250.1250.96770.91670.6750.750.03610.03610.1250.1250.96770.91670.65820.750.0390.0390.1250.1250.95690.91670.63620.750.04340.04340.1250.1250.95690.91670.61080.750.04860.04860.1250.1250.95690.91670.750.1250.1250.95160.91670.95160.91670.95160.91670.94610.91670.94610.91670.94610.91670.94070.91670.94070.91670.94070.91670.93520.91670.93520.91670.93520.91670.93150.91670.93150.91670.93150.91670.93150.83330.93150.83330.93150.83330.92970.83330.92970.83330.92230.83330.92230.83330.92230.83330.92050.83330.92050.83330.91860.750.91860.750.91670.750.91670.750.91490.750.91490.750.91120.750.91120.750.91120.750.90750.750.90750.750.90750.750.90560.750.90560.750.90560.750.90370.750.90370.750.90370.750.90370.750.90180.750.90180.750.90180.750.89990.750.89990.750.89990.750.89990.750.89990.750.89990.750.89990.750.89990.750.89990.750.89370.750.89370.750.89370.750.89370.750.89370.750.89370.750.89130.750.89130.750.89130.750.88890.750.88890.750.88890.750.88630.750.88630.750.88630.750.88380.750.88380.750.88380.750.88380.750.88120.750.88120.750.88120.750.88120.750.87550.750.87550.750.87550.750.86390.750.86390.750.86390.750.86090.750.86090.750.86090.750.85790.750.85790.750.85790.750.85480.750.85480.750.85480.750.85480.750.85160.750.85160.750.85160.750.85160.750.85160.750.85160.750.84810.750.84810.750.84810.750.84470.750.84470.750.84470.750.83770.750.83770.750.83770.750.83770.750.83770.750.83770.750.83770.750.8340.750.8340.750.8340.750.8340.750.8340.750.8340.750.8340.750.8340.750.82990.750.82990.750.82990.750.82990.750.82990.750.82990.750.82570.750.82570.750.82570.750.82570.750.82570.750.82570.750.82570.750.82570.750.82110.750.82110.750.82110.750.81190.750.81190.750.80720.750.80720.750.80720.750.80720.750.80720.750.80250.750.80250.750.80250.750.79770.750.79770.750.79770.750.79770.750.79770.750.79770.750.79270.750.79270.750.79270.750.79270.750.79270.750.79270.750.79270.750.79270.750.79270.750.79270.750.79270.750.78680.750.78680.750.7810.750.7810.750.7810.750.7810.750.77490.750.77490.750.77490.750.77490.750.77490.750.77490.750.77490.750.77490.750.77490.750.76820.750.76820.750.76820.750.76130.750.76130.750.76130.750.76130.750.76130.750.76130.750.76130.750.76130.750.76130.750.75390.750.75390.750.75390.750.75390.750.75390.750.75390.750.74620.750.74620.750.73090.750.73090.750.73090.750.73090.750.73090.750.73090.750.73090.750.72250.750.72250.750.72250.750.72250.750.72250.750.72250.750.71360.750.71360.750.71360.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.70470.750.690.750.690.750.690.750.690.750.6750.750.6750.750.6750.750.6750.750.6750.750.6750.750.6750.750.6750.750.65820.750.65820.750.65820.750.65820.750.65820.750.65820.750.65820.750.65820.750.65820.750.65820.750.65820.750.65820.750.63620.750.63620.750.63620.750.63620.750.63620.750.63620.750.63620.750.61080.750.61080.750.61080.750.61080.750.61080.750.61080.750.61080.750.61080.750.61080.750.61080.750.61080.750.61080.750.61080.750.61080.750.61080.750.61080.750.61080.750.61080.750.61080.750.61080.750.61080.750.61080.750.61080.75

Error bars at 1 se (Greenwood)NoYeserror survivalerror survivalMonths post ProcedureSurvivalSource All Cause Mortality -- Transfapical ApproachStratified by Major Vascular Complication(May 1, 2009 Data)

TA Vasc Log Rank110.983810.006550.00655000.983810.93870.96540.01270.01270.01970.01970.983810.90290.88330.0170.0170.03970.03970.983810.87980.86120.02120.02120.04440.04440.97570.98860.86020.86120.02480.02480.04440.04440.97570.98860.8370.82020.02910.02910.05820.05820.97570.98860.8370.82020.02910.02910.05820.05820.97290.97730.82150.82020.03240.03240.05820.05820.97290.97730.82150.82020.03240.03240.05820.05820.97020.97730.82150.82020.03240.03240.05820.05820.97020.97730.79990.82020.03810.03810.05820.05820.97020.97730.79990.73820.03810.03810.09380.09380.96740.97730.79990.73820.03810.03810.09380.09380.96740.97730.73820.09380.09380.96740.97730.96740.97730.96740.97730.96740.97730.96740.97730.96740.96540.96740.96540.96740.96540.96170.96540.96170.96540.96170.96540.96170.96540.95890.96540.95890.96540.95610.96540.95610.96540.95610.96540.95610.96540.95320.96540.95320.96540.95320.96540.95030.96540.95030.96540.95030.96540.95030.96540.94750.96540.94750.96540.94750.96540.94460.96540.94460.96540.94460.96540.94460.96540.94460.96540.94460.96540.94160.96540.94160.96540.94160.96540.93870.96540.93870.96540.93870.96540.93870.96540.93870.96540.93870.96540.93870.96540.92870.96540.92870.96540.92870.96540.92520.96540.92520.96540.92520.96540.92170.96540.92170.96540.92170.96540.92170.95050.92170.95050.92170.95050.92170.95050.92170.95050.92170.93490.92170.93490.92170.93490.92170.93490.91740.93490.91740.93490.91740.93490.91740.91910.91740.91910.91740.91910.91740.91910.91740.91910.91740.91910.91270.9030.91270.9030.91270.9030.9080.9030.9080.9030.9080.9030.9080.9030.9080.9030.90290.9030.90290.9030.90290.9030.90290.9030.90290.9030.90290.9030.90290.9030.90290.9030.90290.9030.90290.9030.90290.88330.90290.88330.90290.88330.90290.88330.90290.88330.90290.88330.90290.88330.90290.88330.90290.88330.90290.88330.90290.88330.90290.88330.90290.88330.90290.88330.90290.88330.90290.88330.90290.88330.90290.88330.90290.86120.90290.86120.90290.86120.90290.86120.89550.86120.89550.86120.89550.86120.89550.86120.89550.86120.88780.86120.88780.86120.88780.86120.88780.86120.88780.86120.87980.86120.87980.86120.87980.86120.87980.86120.87980.86120.87980.86120.87980.86120.87980.86120.87980.86120.87980.86120.87980.86120.87980.86120.87980.86120.87980.86120.87980.86120.86020.86120.86020.86120.86020.86120.86020.86120.86020.86120.86020.86120.86020.86120.86020.86120.86020.86120.86020.86120.86020.86120.86020.86120.86020.86120.86020.86120.86020.86120.86020.86120.84880.86120.84880.86120.84880.86120.84880.86120.84880.82020.84880.82020.84880.82020.84880.82020.84880.82020.8370.82020.8370.82020.8370.82020.8370.82020.8370.82020.8370.82020.8370.82020.8370.82020.8370.82020.8370.82020.8370.82020.8370.82020.8370.82020.8370.82020.8370.82020.8370.82020.8370.82020.8370.82020.8370.82020.8370.82020.8370.82020.8370.82020.8370.82020.82150.82020.82150.82020.82150.82020.82150.82020.82150.82020.82150.82020.82150.82020.82150.82020.82150.82020.82150.82020.82150.82020.82150.82020.82150.82020.82150.82020.82150.82020.82150.82020.82150.82020.82150.82020.82150.82020.82150.82020.82150.82020.82150.82020.79990.82020.79990.82020.79990.82020.79990.73820.79990.73820.79990.73820.79990.73820.79990.73820.79990.73820.79990.73820.79990.73820.79990.73820.79990.73820.79990.73820.79990.73820.79990.73820.79990.73820.79990.73820.79990.73820.79990.73820.79990.73820.79990.73820.79990.73820.75540.73820.75540.73820.75540.73820.75540.73820.75540.73820.75540.73820.75540.73820.75540.73820.75540.73820.75540.73820.75540.73820.75540.73820.75540.73820.75540.73820.75540.73820.75540.73820.75540.73820.75540.73820.75540.73820.75540.73820.75540.73820.75540.73820.75540.7382

Error bars at 1 se (Greenwood)NoYeserror survivalerror survivalMonths post ProcedureSurvivalSource All Cause Mortality -- Transfemoral ApproachStratified by Major or Minor Vascular Complication(May 1, 2009 Data)

TF Vasc at Risk110.99450.960.003160.003160.03920.03920.99450.960.90120.80.01290.01290.080.080.99450.960.83970.68920.01780.01780.10030.10030.99450.960.79740.68920.02180.02180.10030.10030.98350.960.76520.68920.02530.02530.10030.10030.98350.960.72580.68920.02950.02950.10030.10030.98350.960.70780.68920.03140.03140.10030.10030.97250.960.70780.68920.03140.03140.10030.10030.97250.960.6930.68920.0340.0340.10030.10030.96880.920.6780.68920.03650.03650.10030.10030.96880.920.6610.68920.03930.03930.10030.10030.95960.880.6390.68920.04370.04370.10030.10030.95960.880.61340.68920.04890.04890.10030.10030.95960.880.68920.10030.10030.95410.880.95410.880.95410.880.94850.880.94850.880.94850.880.94290.880.94290.880.94290.880.93730.880.93730.880.93730.880.93360.880.93360.880.93360.880.93360.840.93360.840.93360.840.93170.840.93170.840.92410.840.92410.840.92410.840.92220.840.92220.840.92030.80.92030.80.91840.80.91840.80.91650.80.91650.80.91270.80.91270.80.91270.80.90890.80.90890.80.90890.80.9070.80.9070.80.9070.80.90510.80.90510.80.90510.80.90510.80.90310.80.90310.80.90310.80.90120.80.90120.80.90120.80.90120.80.90120.80.90120.80.90120.80.90120.80.90120.80.89480.80.89480.80.89480.80.89480.80.89480.80.89480.80.89240.80.89240.80.89240.80.89240.74670.89240.74670.89240.74670.88980.74670.88980.74670.88980.74670.88720.74670.88720.74670.88720.74670.88720.74670.88450.74670.88450.74670.88450.74670.88450.74670.87870.74670.87870.74670.87870.74670.86670.74670.86670.74670.86670.74670.86360.74670.86360.74670.86360.74670.86050.74670.86050.74670.86050.74670.85740.74670.85740.74670.85740.74670.85740.74670.8540.74670.8540.74670.8540.74670.8540.74670.8540.74670.8540.74670.85050.74670.85050.74670.85050.74670.84690.74670.84690.74670.84690.74670.83970.74670.83970.74670.83970.74670.83970.74670.83970.74670.83970.74670.83970.74670.83970.68920.83970.68920.83970.68920.83970.68920.83970.68920.83970.68920.83970.68920.83970.68920.83550.68920.83550.68920.83550.68920.83550.68920.83550.68920.83550.68920.83120.68920.83120.68920.83120.68920.83120.68920.83120.68920.83120.68920.83120.68920.83120.68920.82660.68920.82660.68920.82660.68920.81710.68920.81710.68920.81230.68920.81230.68920.81230.68920.81230.68920.81230.68920.80750.68920.80750.68920.80750.68920.80260.68920.80260.68920.80260.68920.80260.68920.80260.68920.80260.68920.79740.68920.79740.68920.79740.68920.79740.68920.79740.68920.79740.68920.79740.68920.79740.68920.79740.68920.79740.68920.79740.68920.79140.68920.79140.68920.78540.68920.78540.68920.78540.68920.78540.68920.77920.68920.77920.68920.77920.68920.77920.68920.77920.68920.77920.68920.77920.68920.77920.68920.77920.68920.77230.68920.77230.68920.77230.68920.76520.68920.76520.68920.76520.68920.76520.68920.76520.68920.76520.68920.76520.68920.76520.68920.76520.68920.75780.68920.75780.68920.75780.68920.75780.68920.75780.68920.75780.68920.750.68920.750.68920.73430.68920.73430.68920.73430.68920.73430.68920.73430.68920.73430.68920.73430.68920.72580.68920.72580.68920.72580.68920.72580.68920.72580.68920.72580.68920.71680.68920.71680.68920.71680.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.70780.68920.6930.68920.6930.68920.6930.68920.6930.68920.6780.68920.6780.68920.6780.68920.6780.68920.6780.68920.6780.68920.6780.68920.6780.68920.6610.68920.6610.68920.6610.68920.6610.68920.6610.68920.6610.68920.6610.68920.6610.68920.6610.68920.6610.68920.6610.68920.6610.68920.6390.68920.6390.68920.6390.68920.6390.68920.6390.68920.6390.68920.6390.68920.61340.68920.61340.68920.61340.68920.61340.68920.61340.68920.61340.68920.61340.68920.61340.68920.61340.68920.61340.68920.61340.68920.61340.68920.61340.68920.61340.68920.61340.68920.61340.68920.61340.68920.61340.68920.61340.68920.61340.68920.61340.68920.61340.68920.61340.6892

Error bars at 1 se (Greenwood)NoYeserror survivalerror survivalMonths post ProcedureSurvivalSource All Cause Mortality -- Transfapical ApproachStratified by Major or Minor Vascular Complication(May 1, 2009 Data)

TF Vasc KM DataTransapical All cause mortality by Major or Minor Vascular Complication: Source data as of 01MAY2009 Patients at Risk by StrataNoYesTimeAt RiskSurvivalStandard ErrorLow CL SurvivalHigh CL SurvivalAt RiskSurvivalStandard ErrorLow CL SurvivalHigh CL Survival05460.99450.00320.98831.0000250.96000.03920.88321.000014250.90120.01290.87590.9264170.80000.08000.64320.956822110.83970.01780.80480.8746120.68920.10030.49270.885831490.79740.02180.75470.840280.68920.10030.49270.885841050.76520.02530.71570.814740.68920.10030.49270.88585840.72580.02950.66800.783630.68920.10030.49270.88586710.70780.03140.64620.769320.68920.10030.49270.88587570.70780.03140.64620.769320.68920.10030.49270.88588460.69300.03400.62630.759720.68920.10030.49270.88589410.67800.03650.60650.749420.68920.10030.49270.885810320.66100.03930.58400.738020.68920.10030.49270.885811270.63900.04370.55330.724720.68920.10030.49270.885812110.61340.04890.51760.709210.68920.10030.49270.88581310.61340.04890.51760.709200.68920.10030.49270.8858

TF Vasc Log RankTransapical All cause mortality by Major or Minor Vascular Complication: Source data as of 01MAY2009LifetimeNoCensoredStdErrLCL_SurvivalUCL_SurvivalYesCensoredStdErrLCL_SurvivalUCL_Survival01011101100.99450.003160.988310.960.03920.8832100.99450.99450.003160.988310.960.03920.883210.03290.99450.003160.988310.960.03920.883210.03290.98350.005460.97280.99420.960.03920.883210.03290.98350.98350.005460.97280.99420.960.03920.883210.06570.98350.005460.97280.99420.960.03920.883210.06570.97250.007010.95870.98620.960.03920.883210.09860.97250.007010.95870.98620.960.03920.883210.09860.96880.007450.95420.98340.920.05430.813710.13140.96880.007450.95420.98340.920.05430.813710.13140.95960.008440.94310.97610.880.0650.752610.13140.95960.95960.008440.94310.97610.880.0650.752610.16430.95960.008440.94310.97610.880.0650.752610.16430.95410.008970.93650.97170.880.0650.752610.16430.95410.95410.008970.93650.97170.880.0650.752610.19710.95410.008970.93650.97170.880.0650.752610.19710.94850.009470.930.96710.880.0650.752610.19710.94850.94850.009470.930.96710.880.0650.752610.230.94850.009470.930.96710.880.0650.752610.230.94290.009950.92340.96250.880.0650.752610.230.94290.94290.009950.92340.96250.880.0650.752610.26280.94290.009950.92340.96250.880.0650.752610.26280.93730.01040.91690.95770.880.0650.752610.26280.93730.93730.01040.91690.95770.880.0650.752610.29570.93730.01040.91690.95770.880.0650.752610.29570.93360.01070.91260.95450.880.0650.752610.29570.93360.93360.01070.91260.95450.880.0650.752610.32850.93360.01070.91260.95450.880.0650.752610.32850.93360.01070.91260.95450.840.07330.69630.98370.32850.93360.93360.01070.91260.95450.840.07330.69630.98370.36140.93360.01070.91260.95450.840.07330.69630.98370.36140.93170.01080.91040.95290.840.07330.69630.98370.42710.93170.01080.91040.95290.840.07330.69630.98370.42710.92410.01140.90180.94650.840.07330.69630.98370.42710.92410.92410.01140.90180.94650.840.07330.69630.98370.460.92410.01140.90180.94650.840.07330.69630.98370.460.92220.01150.89960.94480.840.07330.69630.98370.49280.92220.01150.89960.94480.840.07330.69630.98370.49280.92030.01170.89750.94320.80.080.64320.95680.52570.92030.01170.89750.94320.80.080.64320.95680.52570.91840.01180.89530.94150.80.080.64320.95680.55850.91840.01180.89530.94150.80.080.64320.95680.55850.91650.01190.89310.93990.80.080.64320.95680.59140.91650.01190.89310.93990.80.080.64320.95680.59140.91270.01220.88890.93660.80.080.64320.95680.59140.91270.91270.01220.88890.93660.80.080.64320.95680.62420.91270.01220.88890.93660.80.080.64320.95680.62420.90890.01240.88460.93320.80.080.64320.95680.62420.90890.90890.01240.88460.93320.80.080.64320.95680.68990.90890.01240.88460.93320.80.080.64320.95680.68990.9070.01250.88240.93160.80.080.64320.95680.68990.9070.9070.01250.88240.93160.80.080.64320.95680.72280.9070.01250.88240.93160.80.080.64320.95680.72280.90510.01270.88030.92990.80.080.64320.95680.72280.90510.90510.01270.88030.92990.80.080.64320.95680.75560.90510.90510.01270.88030.92990.80.080.64320.95680.78850.90510.01270.88030.92990.80.080.64320.95680.78850.90310.01280.87810.92820.80.080.64320.95680.78850.90310.90310.01280.87810.92820.80.80.080.64320.95680.82140.90310.01280.87810.92820.80.080.64320.95680.82140.90120.01290.87590.92640.80.080.64320.95680.82140.90120.90120.01290.87590.92640.80.080.64320.95680.85420.90120.90120.01290.87590.92640.80.080.64320.95680.88710.90120.90120.01290.87590.92640.80.080.64320.95680.91990.90120.90120.01290.87590.92640.80.80.080.64320.95680.95280.90120.90120.01290.87590.92640.80.080.64320.95680.98560.90120.90120.01290.87590.92640.80.80.080.64320.956810.90120.01290.87590.92640.80.080.64320.95681.01850.90120.01290.87590.92640.80.080.64320.95681.01850.89480.01330.86870.92090.80.080.64320.95681.01850.89480.89480.01330.86870.92090.80.80.080.64320.95681.05130.89480.89480.01330.86870.92090.80.080.64320.95681.08420.89480.89480.01330.86870.92090.80.080.64320.95681.1170.89480.89480.01330.86870.92090.80.80.080.64320.95681.14990.89480.01330.86870.92090.80.080.64320.95681.14990.89240.01350.86590.91880.80.080.64320.95681.14990.89240.89240.01350.86590.91880.80.080.64320.95681.18280.89240.01350.86590.91880.80.080.64320.95681.18280.89240.01350.86590.91880.74670.09070.56890.92451.18280.89240.89240.01350.86590.91880.74670.09070.56890.92451.21560.89240.01350.86590.91880.74670.09070.56890.92451.21560.88980.01370.86290.91670.74670.09070.56890.92451.21560.88980.88980.01370.86290.91670.74670.09070.56890.92451.24850.88980.01370.86290.91670.74670.09070.56890.92451.24850.88720.01390.85990.91440.74670.09070.56890.92451.24850.88720.88720.01390.85990.91440.74670.09070.56890.92451.28130.88720.88720.01390.85990.91440.74670.09070.56890.92451.31420.88720.01390.85990.91440.74670.09070.56890.92451.31420.88450.01410.85680.91220.74670.09070.56890.92451.31420.88450.88450.01410.85680.91220.74670.74670.09070.56890.92451.3470.88450.88450.01410.85680.91220.74670.09070.56890.92451.37990.88450.01410.85680.91220.74670.09070.56890.92451.37990.87870.01460.850.90730.74670.09070.56890.92451.37990.87870.87870.01460.850.90730.74670.09070.56890.92451.41270.87870.01460.850.90730.74670.09070.56890.92451.41270.86670.01560.83610.89730.74670.09070.56890.92451.41270.86670.86670.01560.83610.89730.74670.09070.56890.92451.44560.86670.01560.83610.89730.74670.09070.56890.92451.44560.86360.01580.83260.89470.74670.09070.56890.92451.44560.86360.86360.01580.83260.89470.74670.09070.56890.92451.47840.86360.01580.83260.89470.74670.09070.56890.92451.47840.86050.01610.8290.89210.74670.09070.56890.92451.47840.86050.86050.01610.8290.89210.74670.09070.56890.92451.51130.86050.01610.8290.89210.74670.09070.56890.92451.51130.85740.01630.82530.88940.74670.09070.56890.92451.51130.85740.85740.01630.82530.88940.74670.09070.56890.92451.54410.85740.85740.01630.82530.88940.74670.09070.56890.92451.5770.85740.01630.82530.88940.74670.09070.56890.92451.5770.8540.01660.82150.88660.74670.09070.56890.92451.5770.8540.8540.01660.82150.88660.74670.09070.56890.92451.60990.8540.8540.01660.82150.88660.74670.09070.56890.92451.64270.8540.8540.01660.82150.88660.74670.09070.56890.92451.67560.8540.8540.01660.82150.88660.74670.09070.56890.92451.70840.8540.01660.82150.88660.74670.09070.56890.92451.70840.85050.01690.81730.88360.74670.09070.56890.92451.70840.85050.85050.01690.81730.88360.74670.09070.56890.92451.74130.85050.01690.81730.88360.74670.09070.56890.92451.74130.84690.01720.81320.88070.74670.09070.56890.92451.74130.84690.84690.01720.81320.88070.74670.09070.56890.92451.77410.84690.01720.81320.88070.74670.09070.56890.92451.77410.83970.01780.80480.87460.74670.09070.56890.92451.77410.83970.83970.01780.80480.87460.74670.09070.56890.92451.8070.83970.83970.01780.80480.87460.74670.09070.56890.92451.83980.83970.83970.01780.80480.87460.74670.09070.56890.92451.87270.83970.83970.01780.80480.87460.74670.09070.56890.92451.90550.83970.83970.01780.80480.87460.74670.09070.56890.92451.93840.83970.01780.80480.87460.74670.09070.56890.92451.93840.83970.01780.80480.87460.68920.10030.49270.88581.93840.83970.83970.01780.80480.87460.68920.10030.49270.88581.97130.83970.83970.01780.80480.87460.68920.10030.49270.885820.83970.01780.80480.87460.68920.10030.49270.88582.00410.83970.83970.01780.80480.87460.68920.68920.10030.49270.88582.0370.83970.83970.01780.80480.87460.68920.68920.10030.49270.88582.06980.83970.83970.01780.80480.87460.68920.10030.49270.88582.10270.83970.01780.80480.87460.68920.10030.49270.88582.10270.83550.01820.79990.87120.68920.10030.49270.88582.10270.83550.83550.01820.79990.87120.68920.10030.49270.88582.13550.83550.83550.01820.79990.87120.68920.68920.10030.49270.88582.20120.83550.83550.01820.79990.87120.68920.10030.49270.88582.23410.83550.83550.01820.79990.87120.68920.10030.49270.88582.26690.83550.01820.79990.87120.68920.10030.49270.88582.26690.83120.01860.79480.86770.68920.10030.49270.88582.26690.83120.83120.01860.79480.86770.68920.10030.49270.88582.29980.83120.83120.01860.79480.86770.68920.10030.49270.88582.33260.83120.83120.01860.79480.86770.68920.10030.49270.88582.39840.83120.83120.01860.79480.86770.68920.10030.49270.88582.43120.83120.83120.01860.79480.86770.68920.10030.49270.88582.49690.83120.83120.01860.79480.86770.68920.10030.49270.88582.56260.83120.01860.79480.86770.68920.10030.49270.88582.56260.82660.01910.78920.8640.68920.10030.49270.88582.56260.82660.82660.01910.78920.8640.68920.10030.49270.88582.59550.82660.01910.78920.8640.68920.10030.49270.88582.59550.81710.020.77780.85630.68920.10030.49270.88582.62830.81710.020.77780.85630.68920.10030.49270.88582.62830.81230.02050.77220.85240.68920.10030.49270.88582.62830.81230.81230.02050.77220.85240.68920.10030.49270.88582.6940.81230.81230.02050.77220.85240.68920.10030.49270.88582.72690.81230.81230.02050.77220.85240.68920.10030.49270.88582.75980.81230.02050.77220.85240.68920.10030.49270.88582.75980.80750.02090.76650.84840.68920.10030.49270.88582.75980.80750.80750.02090.76650.84840.68920.68920.10030.49270.88582.85830.80750.02090.76650.84840.68920.10030.49270.88582.85830.80260.02130.76070.84440.68920.10030.49270.88582.85830.80260.80260.02130.76070.84440.68920.10030.49270.88582.89120.80260.80260.02130.76070.84440.68920.10030.49270.88582.9240.80260.80260.02130.76070.84440.68920.10030.49270.88582.95690.80260.80260.02130.76070.84440.68920.10030.49270.88582.98970.80260.02130.76070.84440.68920.10030.49270.88582.98970.79740.02180.75470.84020.68920.10030.49270.88582.98970.79740.79740.02180.75470.84020.68920.10030.49270.885830.79740.02180.75470.84020.68920.10030.49270.88583.02260.79740.79740.02180.75470.84020.68920.10030.49270.88583.05540.79740.79740.02180.75470.84020.68920.10030.49270.88583.12110.79740.79740.02180.75470.84020.68920.10030.49270.88583.1540.79740.79740.02180.75470.84020.68920.10030.49270.88583.18690.79740.79740.02180.75470.84020.68920.10030.49270.88583.21970.79740.79740.02180.75470.84020.68920.10030.49270.88583.25260.79740.79740.02180.75470.84020.68920.10030.49270.88583.31830.79740.02180.75470.84020.68920.10030.49270.88583.31830.79140.02250.74740.83540.68920.10030.49270.88583.35110.79140.02250.74740.83540.68920.10030.49270.88583.35110.78540.02310.74020.83060.68920.10030.49270.88583.3840.78540.78540.02310.74020.83060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TA Vasc Major at RiskTransapical All cause mortality by Major or Minor Vascular Complication: Source data as of 01MAY2009TestChi-SquareDFPr > Chi-SquareLog-Rank1.255310.2625Wilcoxon3.002410.0831-2Log(LR)1.117710.2904

TA Vasc Major KM DataTransfemoral All cause mortality by Major or Minor Vascular Complication: & study data as of 01MAY2009 Patients at Risk by StrataNoYesTimeAt RiskSurvivalStandard ErrorLow CL SurvivalHigh CL SurvivalAt RiskSurvivalStandard ErrorLow CL SurvivalHigh CL Survival03710.98380.00660.97100.9967881.00000.00001.00001.000012990.93870.01270.91380.9635700.96540.01970.92681.000021490.90290.01700.86950.9363450.88330.03970.80560.961131040.87980.02120.83820.9213350.86120.04440.77420.94834790.86020.02480.81160.9089230.86120.04440.77420.94835700.83700.02910.77990.8940160.82020.05820.70610.93436620.83700.02910.77990.8940150.82020.05820.70610.93437530.82150.03240.75790.8850130.82020.05820.70610.93438470.82150.03240.75790.8850130.82020.05820.70610.93439410.82150.03240.75790.8850120.82020.05820.70610.934310370.79990.03810.72520.8745100.82020.05820.70610.934311340.79990.03810.72520.874590.73820.09380.55430.922112190.79990.03810.72520.874560.73820.09380.55430.92211380.75540.05620.64520.865600.73820.09380.55430.92211420.75540.05620.64520.865600.73820.09380.55430.92211520.75540.05620.64520.865600.73820.09380.55430.92211610.75540.05620.64520.865600.73820.09380.55430.9221

TA Vasc Major Log RankTransfemoral All cause mortality by Major or Minor Vascular Complication: & study data as of 01MAY2009LifetimeNoCensoredStdErrLCL_SurvivalUCL_SurvivalYesCensoredStdErrLCL_SurvivalUCL_Survival01011101100.98380.006550.9710.9967101100.98380.98380.006550.9710.996710110.03290.98380.006550.9710.996710110.03290.97570.008020.95990.99140.98860.01130.966510.03290.97570.97570.008020.95990.99140.98860.01130.966510.06570.97570.008020.95990.99140.98860.01130.966510.06570.97290.008450.95640.98950.97730.01590.946110.09860.97290.008450.95640.98950.97730.01590.946110.09860.97020.008850.95280.98750.97730.01590.946110.09860.97020.97020.008850.95280.98750.97730.97730.01590.946110.13140.97020.008850.95280.98750.97730.01590.946110.13140.96740.009250.94930.98560.97730.01590.946110.13140.96740.96740.009250.94930.98560.97730.01590.946110.19710.96740.009250.94930.98560.97730.97730.01590.946110.230.96740.96740.009250.94930.98560.97730.01590.946110.26280.96740.96740.009250.94930.98560.97730.97730.01590.946110.29570.96740.96740.009250.94930.98560.97730.97730.01590.946110.32850.96740.009250.94930.98560.97730.01590.946110.32850.96740.009250.94930.98560.96540.01970.926810.32850.96740.96740.009250.94930.98560.96540.01970.926810.36140.96740.009250.94930.98560.96540.01970.926810.36140.96170.010.94210.98140.96540.01970.926810.36140.96170.010.94210.98140.96540.96540.01970.926810.39430.96170.96170.010.94210.98140.96540.01970.926810.42710.96170.010.94210.98140.96540.01970.926810.42710.95890.01040.93850.97930.96540.01970.926810.460.95890.01040.93850.97930.96540.01970.926810.460.95610.01070.9350.97710.96540.01970.926810.460.95610.95610.01070.9350.97710.96540.96540.01970.926810.49280.95610.95610.01070.9350.97710.96540.01970.926810.52570.95610.01070.9350.97710.96540.01970.926810.52570.95320.01110.93150.97490.96540.01970.926810.52570.95320.95320.01110.93150.97490.96540.01970.926810.55850.95320.01110.93150.97490.96540.01970.926810.55850.95030.01140.92790.97270.96540.01970.926810.59140.95030.01140.92790.97270.96540.96540.01970.926810.62420.95030.01140.92790.97270.96540.96540.01970.926810.65710.95030.01140.92790.97270.96540.01970.926810.65710.94750.01170.92440.97050.96540.01970.926810.65710.94750.94750.01170.92440.97050.96540.01970.926810.68990.94750.01170.92440.97050.96540.01970.926810.68990.94460.01210.92090.96820.96540.01970.926810.75560.94460.94460.01210.92090.96820.96540.01970.926810.78850.94460.94460.01210.92090.96820.96540.01970.926810.82140.94460.01210.92090.96820.96540.96540.01970.926810.85420.94460.94460.01210.92090.96820.96540.01970.926810.88710.94460.01210.92090.96820.96540.01970.926810.88710.94160.01240.91740.96590.96540.01970.926810.88710.94160.94160.01240.91740.96590.96540.96540.01970.926810.91990.94160.01240.91740.96590.96540.01970.926810.91990.93870.01270.91380.96350.96540.01970.926810.91990.93870.93870.01270.91380.96350.96540.96540.01970.926810.95280.93870.93870.01270.91380.96350.96540.01970.926810.98560.93870.93870.01270.91380.96350.96540.96540.01970.9268110.93870.01270.91380.96350.96540.01970.926811.01850.93870.93870.01270.91380.96350.96540.96540.01970.926811.05130.93870.01270.91380.96350.96540.01970.926811.05130.92870.01380.90160.95570.96540.01970.926811.05130.92870.92870.01380.90160.95570.96540.01970.926811.08420.92870.01380.90160.95570.96540.01970.926811.08420.92520.01420.89750.9530.96540.01970.926811.08420.92520.92520.01420.89750.9530.96540.96540.01970.926811.1170.92520.01420.89750.9530.96540.01970.926811.1170.92170.01450.89320.95020.96540.01970.926811.1170.92170.92170.01450.89320.95020.96540.96540.01970.926811.14990.92170.01450.89320.95020.96540.01970.926811.14990.92170.01450.89320.95020.95050.02430.90280.99821.14990.92170.92170.01450.89320.95020.95050.95050.02430.90280.99821.18280.92170.92170.01450.89320.95020.95050.95050.02430.90280.99821.21560.92170.92170.01450.89320.95020.95050.95050.02430.90280.99821.24850.92170.01450.89320.95020.95050.02430.90280.99821.24850.92170.01450.89320.95020.93490.02850.87910.99081.24850.92170.92170.01450.89320.95020.93490.02850.87910.99081.28130.92170.92170.01450.89320.95020.93490.02850.87910.99081.31420.92170.01450.89320.95020.93490.02850.87910.99081.31420.91740.01510.88780.9470.93490.02850.87910.99081.31420.91740.91740.01510.88780.9470.93490.93490.02850.87910.99081.3470.91740.01510.88780.9470.93490.02850.87910.99081.3470.91740.01510.88780.9470.91910.03210.85610.9821.3470.91740.91740.01510.88780.9470.91910.03210.85610.9821.37990.91740.91740.01510.88780.9470.91910.03210.85610.9821.41270.91740.91740.01510.88780.9470.91910.91910.03210.85610.9821.44560.91740.91740.01510.88780.9470.91910.03210.85610.9821.47840.91740.01510.88780.9470.91910.03210.85610.9821.47840.91270.01570.88190.94360.9030.03540.83360.97231.47840.91270.91270.01570.88190.94360.9030.9030.03540.83360.97231.51130.91270.01570.88190.94360.9030.03540.83360.97231.51130.9080.01640.87590.940.9030.03540.83360.97231.51130.9080.9080.01640.87590.940.9030.9030.03540.83360.97231.54410.9080.9080.01640.87590.940.9030.9030.03540.83360.97231.5770.9080.9080.01640.87590.940.9030.03540.83360.97231.60990.9080.01640.87590.940.9030.03540.83360.97231.609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
TF Vasc Major at RiskTransfemoral All cause mortality by Major or Minor Vascular Complication: Source data as of 01MAY2009TestChi-SquareDFPr > Chi-SquareLog-Rank0.011210.9156Wilcoxon0.097510.7549-2Log(LR)0.002110.9632

TF Vasc Major KM DataTransapical All cause mortality by Major Vascular Complication: & study data as of 01MAY2009 Patients at Risk by StrataNoYesTimeAt RiskSurvivalStandard ErrorLow CL SurvivalHigh CL SurvivalAt RiskSurvivalStandard ErrorLow CL SurvivalHigh CL Survival05590.99460.00310.98861.0000120.91670.07980.76031.000014340.89990.01280.87480.925080.75000.12500.50500.995022170.83400.01790.79880.869260.75000.12500.50500.995031520.79270.02170.75010.835250.75000.12500.50500.995041060.76130.02500.71220.810330.75000.12500.50500.99505850.72250.02920.66530.779620.75000.12500.50500.99506710.70470.03100.64390.765520.75000.12500.50500.99507570.70470.03100.64390.765520.75000.12500.50500.99508460.69000.03370.62400.756020.75000.12500.50500.99509410.67500.03610.60420.745920.75000.12500.50500.995010320.65820.03900.58180.734520.75000.12500.50500.995011270.63620.04340.55110.721320.75000.12500.50500.995012110.61080.04860.51560.706010.75000.12500.50500.99501310.61080.04860.51560.706000.75000.12500.50500.9950

TF Vasc Major Log RankTransapical All cause mortality by Major Vascular Complication: & study data as of 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0.1250.5050.995110.63620.04340.55110.72130.750.1250.5050.99511.00620.63620.63620.04340.55110.72130.750.1250.5050.99511.0390.63620.63620.04340.55110.72130.750.750.1250.5050.99511.07190.63620.04340.55110.72130.750.1250.5050.99511.07190.61080.04860.51560.7060.750.1250.5050.99511.20330.61080.61080.04860.51560.7060.750.1250.5050.99511.2690.61080.61080.04860.51560.7060.750.1250.5050.99511.4990.61080.61080.04860.51560.7060.750.1250.5050.99511.76180.61080.61080.04860.51560.7060.750.1250.5050.99511.82750.61080.61080.04860.51560.7060.750.1250.5050.99511.89320.61080.61080.04860.51560.7060.750.1250.5050.99511.92610.61080.61080.04860.51560.7060.750.1250.5050.99511.95890.61080.61080.04860.51560.7060.750.1250.5050.99511.99180.61080.61080.04860.51560.7060.750.1250.5050.995120.61080.04860.51560.7060.750.1250.5050.99512.02460.61080.61080.04860.51560.7060.750.1250.5050.99512.09030.61080.61080.04860.51560.7060.750.1250.5050.99512.15610.61080.61080.04860.51560.7060.750.750.1250.5050.99512.25460.61080.61080.04860.51560.7060.750.1250.5050.99512.3860.61080.61080.04860.51560.7060.750.1250.5050.99512.45170.61080.61080.04860.51560.7060.750.1250.5050.99512.51750.61080.61080.04860.51560.7060.750.1250.5050.99512.58320.61080.61080.04860.51560.7060.750.1250.5050.99512.64890.61080.61080.04860.51560.7060.750.1250.5050.995130.61080.04860.51560.7060.750.1250.5050.99513.56880.61080.61080.04860.51560.7060.750.1250.5050.995140.61080.04860.51560.7060.750.1250.5050.995

TF Death by Euro at Risk (30)Transapical All cause mortality by Major Vascular Complication: Source data as of 01MAY2009TestChi-SquareDFPr > Chi-SquareLog-Rank0.102710.7486Wilcoxon1.404110.236-2Log(LR)0.003310.9539

TF Death by Euro KM Data (30)Transfemoral All cause mortality by Major Vascular Complication: & study data as of 01MAY2009 Patients at Risk by StrataNoYesTimeAt RiskSurvivalStandard ErrorLow CL SurvivalHigh CL SurvivalAt RiskSurvivalStandard ErrorLow CL SurvivalHigh CL Survival04150.98550.00590.97410.9970441.00000.00001.00001.000013330.94250.01160.91970.9654360.95450.03140.89301.000021690.90660.01590.87540.9378250.83900.06120.71920.958931190.88620.01940.84810.9243200.80250.06850.66820.93684890.86880.02260.82450.9131130.80250.06850.66820.93685780.84790.02650.79600.899880.72960.09340.54660.91266690.84790.02650.79600.899880.72960.09340.54660.91267590.83370.02960.77580.891770.72960.09340.54660.91268530.83370.02960.77580.891770.72960.09340.54660.91269460.83370.02960.77580.891770.72960.09340.54660.912610400.81340.03510.74450.882370.72960.09340.54660.912611360.79310.03970.71520.870970.72960.09340.54660.912612210.79310.03970.71520.870940.72960.09340.54660.91261380.75340.05400.64750.859300.72960.09340.54660.91261420.75340.0540.64750.859300.72960.09340.54660.91261520.75340.0540.64750.859300.72960.09340.54660.91261610.75340.0540.64750.859300.72960.09340.54660.9126

TF Death by Euro Log Rank (30)Transfemoral All cause mortality by Major Vascular Complication: & study data as of 01MAY2009LifetimeNoCensoredStdErrLCL_SurvivalUCL_SurvivalYesCensoredStdErrLCL_SurvivalUCL_Survival01011101100.98550.005860.97410.997101100.98550.98550.005860.97410.99710110.03290.98550.005860.97410.99710110.03290.97820.007170.96420.99230.97730.02250.933210.03290.97820.97820.007170.96420.99230.97730.02250.933210.06570.97820.007170.96420.99230.97730.02250.933210.06570.97580.007560.9610.99060.95450.03140.89310.09860.97580.007560.9610.99060.95450.03140.89310.09860.97340.007920.95780.98890.95450.03140.89310.09860.97340.97340.007920.95780.98890.95450.03140.89310.13140.97340.007920.95780.98890.95450.03140.89310.13140.97090.008280.95470.98710.95450.03140.89310.13140.97090.97090.008280.95470.98710.95450.03140.89310.19710.97090.97090.008280.95470.98710.95450.03140.89310.230.97090.97090.008280.95470.98710.95450.03140.89310.26280.97090.97090.008280.95470.98710.95450.03140.89310.29570.97090.97090.008280.95470.98710.95450.95450.03140.89310.32850.97090.008280.95470.98710.95450.03140.89310.32850.96840.008640.95140.98530.95450.03140.89310.32850.96840.96840.008640.95140.98530.95450.03140.89310.36140.96840.008640.95140.98530.95450.03140.89310.36140.96330.009310.9450.98150.95450.03140.89310.36140.96330.96330.009310.9450.98150.95450.95450.03140.89310.39430.96330.96330.009310