2/28/2010. Speakers s name: Paul Chiam. I have the following potential conflicts of interest to report: NONE. Antegrade transvenous transseptal route

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1 Transcatheter Aortic Valve Implantation Asian perspective Speakers s name: Paul Chiam Paul TL Chiam MBBS, MRCP, FACC I have the following potential conflicts of interest to report: NONE Consultant National Heart Center Singapore 1 st human 2002 by Cribier et al Antegrade transvenous transseptal route Edwards-Sapiens Balloon expandable, stainless steel frame Bovine (formerly equine) pericardial leaflets CE marked; FDA randomized trial enrolment complete 23mm and 26mm diameters Approximately 14mm and 16mm height 1

2 Chiam at al. Am Heart J 2009 Chiam at al. Am Heart J 2009 CoreValve Self-expandable expandable THV Nitinol frame Porcine pericardial leaflets Longer device CE marked; awaiting FDA approval for randomized trial Retrograde, transfemoral Subclavian artery cutdown in PVD Easier deployment 18 F sheath Vascular injury less of an issue 2

3 30-d mortality 1 st half 14.3% 2 nd half 8.3% 168 patients; TF 113, TA 55 Median EuroScore 28.6% Median STS 9.1 Procedural success 94.1% (1 st half 89% 2 nd half 98%) 30-d mortality 11.3% (TF 8% vs TA 18.2%, p= 0.07) 30-d mortality TF: 12.3% 3.6%; TA: 20.5% 11.1% CVA 4.2% (TF 5.3% vs TA 1.8%, p= 0.43) 1 yr survival 74% Paravalvular leak common, generally mild Webb et al. Circulation 2009 Webb et al. Circulation 2009 SOURCE registry Transfemoral N= 305 Current results Walther et al Transapical N= 168 Mean EuroScore 26.4% Procedural success 95% Mean EuroScore 27% Procedural success 92.8% Procedural mortality 0.3% 30-d mortality 6.4% CVA 3.4% Presented at TCT d mortality 15% CVA 2.9% Pooled results show overall 30-d mortality ~ 10% Procedural success 94 98% TCT

4 FRANCE registry FRench Aortic National Corevalve and Edwards registry 244 patients 16 centres Prospective registry AS < 0.6cm2 NYHA at least II High surgical risk Edwards: TF 39%; TA 29% Corevalve: TF 27%, SC 5% Similar baseline charateristics except higher PVD in TA and SC groups 30-d mortality Edwards TF (n=95) Corevalve TF (n=66) Edwards TA (n=71) Corevalve SC (n=12) 8.4% 15.1% 16.9% 8.3% 0.32 Stroke 2.1% 3.0% - 8.3% 0.16 PPM rate 5.3% 27.2% 4.2% 25% <0.001 Vascular injury 5.2% 7.5% 7.0% 8.3% 0.83 Transfusion 8.4% 13.6% 27.4% 83.3% <0.001 Device success 97% Sustained hemodynamic and clinical improvement Results between devices comparable, except for higher PPM rate with Corevalve p TF program Feb 2009 TA program Mar 2009 in Asia Case selection: Deemed at high risk for open AVR or non-operable operable by 2 surgeons Case discussed at our combined conference 4

5 Pre-procedure work up: Echo Cardiac cath/ ilio-femoral angio/ root aortogram Duplex ilio-femoral arteries ± CT of the distal aorta and iliofemoral vessels ± CTA of the heart Procedure: GA, TEE Groin cutdown or anterolateral thoracotomy 10 cases to date 4 transfemoral, 6 transapical Mean age: 72 yrs (55 86) 5 males, 5 females Mean AVA: 0.69 cm2 ( cm2) Mean EuroScore: 16.6% 8 x 23mm THV, 2 x 26mm THV Other high risk reasons: Previous mastectomy + irradiation 2 Previous CABG heart with adherent cardiac structures 1 Porcelain aorta 1 Previous MVR + elderly female + frail Familial hyperlipidemia + CABG + CVAs + bilat CEA (diffuse restenosis of both CCAs/ ICAs) + occluded R vertebral + L subclavian stent + PAD Severe COPD Transfemoral procedure Catheter used 5

6 Valve crossed and valvuloplasty performed Valve crimped in cath lab 22F or 24F sheath placed Retroflex catheter placed in a loader Assembly advanced into sheath Retroflex catheter navigated around arch THV placed within the native valve Position assessed by aortograms and TEE Rapid pacing initiated THV balloon inflated and deflated Pacing turned off 6

7 Catheter and wire removed Transapical procedure Position, gradient and AR assessed by TEE Aortogram Final result 7

8 Results: 8 successful cases 2 deaths 1 TF approach due to iliac artery rupture (despite suitable anatomy) due to aortic dissection 1 TA approach due to migration of THV and subsequent hemodynamic compromise Other complications: 1 limited iliac artery dissection (TF) 2 pleural effusions (TA) 1 resolved, 1 required pleurocentesis Remaining 8 were well at 1 month 1-2 NYHA class improvement Average MPG: 12 mmhg (9 20) Paravalvular leak trivial (3), mild (1), none (4) Conclusions: feasible in Asian patients although not without complications?? Due to smaller build,??? Increased fraility (esp elderly females) Further data required to refine selection criteria and validate role of in Asian patients Awaiting device improvements: Sapien XT THV cobalt chromuim stent (compared to current stainless steel) lower profile THV Retroflex 3 delivery catheter facilitate crossing of aortic valve Need for TA Current Edwards sheath size is 22F (~ 8.3mm) 18F sheath by 4 th quarter 2010 (hopefully)!!! Current CoreValve sheath size 18F (~6.7mm) However, significant minority of Asians may have ilio- femoral < 6mm 18F delivery sheath reduced vessel size required and reduced vessel injury Particularly if also concomitant PAD 8

9 Iliac dimensions in Asian patients referred for U/S of aorto-iliacs - Stenosis > 50% present in 12% - Iliac tortuosity mod-severe in 10% - Age 80 years significant predictor of vessels < 6mm 412 patients, mean age 66 ± 12 yrs in selected bicuspid AS?? How to assess these technologies and approaches? Percutaneous Transcatheter Heart Valve Implantation in a Bicuspid Aortic Valve Chiam et al. JACC Cardiovascular Interventions (In press) JACC Cardiovascular Interventions

10 Implantation: ease and accuracy Immediate: dislodgement / embolization, valve hemodynamics Peri-procedural (up to 30-days) MACCE Short term (up to 1 yr) Valve function, symptom improvement, LV indices Long term (> 1 yr) Valve durability, QOL Complications common to both: Vascular injury (femoral route) Valve embolization Misplacement Coronary obstruction Inducing MR Paravalvular leak?? Stent fracture Solution: Smaller profile device Retrievable and repositionable Improved devices Profile Deliverability Retrievability Repositionability Durability What is the future Demonstration of non-inferiority to surgical AVR in high risk groups Am Heart J 2009; 157: Extending indications to lower risk populations 10

11 Impact of on treatment of AS More patients can now be offered treatment Choice of surgical valves? More bioprosthesis at younger age?? Treatment of severe asymptomatic disease Longer term durability data will determine these issues FIM devices 11

12 Pre-clinical devices Thank you 12