SHA24/074003

Transapical Aortic Valve Implantation

SHA, GHA , Riyadh, Feb 2013

SHA, GHA , Riyadh, Feb 2013

SHA, GHA , Riyadh, Feb 2013

SHA, GHA , Riyadh, Feb 2013

Fundamentals for TAVI Program

(4 T) Theory (Rationale) Team work Training Technology &Equipments SHA, GHA , Riyadh, Feb 2013

Joint Task Force Positioning Paper: ”‟Transcatheter valve implantations for patients with Aortic Stenosis

Technique is feasible and provides hemodynamic ″ ″ and clinical improvements for up to 2 years This technique should be restricted to high-risk″ ″ patients or those with contraindications for surgery SHA, GHA , Riyadh, Feb 2013

Team

Work

Training

SHA, GHA , Riyadh, Feb 2013

Technology & Equipment

INDICATIONS

Patient Selection  The following are the four steps of patient

selection:

 confirmation the severity of AS;  evaluation of symptoms;  analysis of the Risk of surgery / Evaluation of

life expectancy and quality of life;  assessment of the feasibility and exclusion of contraindications for TAVI.

SHA, GHA , Riyadh, Feb 2013

:Transapical Indication  Diffuse Peripheral Vessels  Small vessel Diameter  (less than 6 mm) For Novaflex system

 Porcelain Aorta  Extensive tortuosity of vessels  Unable to cross native valve & Failure of BAV  TF procedural complications

SHA, GHA , Riyadh, Feb 2013

!!Not Only Euro & STS score

SHA, GHA , Riyadh, Feb 2013

( TAVI ) :The Saudi experience

.Immediate and 18 Months Follow-Up

Prince Sultan Cardiac Center & King Faisal Specialist Hospital and Research Center, Riyadh , Saudi Arabia

TAVI The Saudi Experience April 2009 – October 2010 (Total of 42 patients)

27 TA Ed Sabien

15 TF Ed Sabien

SHA, GHA , Riyadh, Feb 2013

OBJECTIVES: To evaluate the immediate and intermediate results of Edward’s Sapien Transfemoral (TF) and Transapical (TA) TAVI done in Saudi Arabia with 18 months F/U.

SHA, GHA , Riyadh, Feb 2013

TAVI Patient’s Data Edwards Sapien Valve (N=42) Demographic Data Demographic Data

Min/Max

Average

Euroscore

49/ 10

38+ 13

Age (yrs)

105/ 55

+ 880.9

F/M) Gender )

42 / 18

EF

65 / 25

PAP (s)

80/ 25

42.9%

SHA, GHA , Riyadh, Feb 2013

%47.9+7

49.6+10 mmHg

TAVI Patient’s Data Edwards Sapien Valve (N=42) Demographic Data COPD

15/42

35.7%

Renal Impairment ((Cr>200 CVA

18/42

42.9%

8/42

19%

PVD

25/42

59.5%

Porcelain Aorta

7/42

16.7%

CAD or previous PCI

57.1%

Pre-TAVI PCI

24/42 9/42

Previous CABG

11/42

% 26.2

SHA, GHA , Riyadh, Feb 2013

21.4%

(Technique) Transapical to Transfemoral Ratio (n=42)

SHA, GHA , Riyadh, Feb 2013

Edwards Sapien Valve Size 23 mm Vs Size 26 mm (42=(n

SHA, GHA , Riyadh, Feb 2013

TAVI Patient’s Data Edwards Sapien Valve (N=42)

Postoperative Outcome Demographic Data

Min/Max

Mean

Hospital Stay (days)

30<-- 2

8.5+4 days (Median 7 days(

Over all Mortality (1 month)

42/ 5

11.9%

18 month Survival

37/42

88.1%

88.1%

month survival 18

SHA, GHA , Riyadh, Feb 2013

TAVI 6m, 12m, 18m Survival ( (n=42

SHA, GHA , Riyadh, Feb 2013

Post TAVI Paravalvular Leak ((n=42

SHA, GHA , Riyadh, Feb 2013

TAVI Patient’s Data Edwards Sapien Valve

(N=42)

Postoperative Data DATA Postoperative Peak AV Gradient Postoperative EF Postoperative PAP

MIN/MAX

Mean

P value

33 - 8

10.8+4 mmHg 52.2+4%

p<0.0001

37.8+ 6 mmHg

P<0.033

65% – 25 80 – 25 mm Hg

SHA, GHA , Riyadh, Feb 2013

P<0.012

TAVI Patientâ&#x20AC;&#x2122;s Data Edwards Sapien Valve

(N=42)

Postoperative Complications Cardiac Tamponade

2/42

% 4.8

Apical Tear

1/42

2.4 %

Coronary artery occlusion/Embolisation

1/42

2.4 %

Postoperative Bleeding (Reopening)

3/42

% 7.1

SHA, GHA , Riyadh, Feb 2013

TAVI Patientâ&#x20AC;&#x2122;s Data Edwards Sapien Valve (N=42) Postoperative Complications

Postop PPM

1/42

% 2.4

Postop CVA

1 / 42

2.4%

Postop Dialysis

5/42

11.9 %

Vascular Complications Re-intubation

2/42

% 4.8

3/42

7.1%

Wound Infection

2/42

% 4.8

SHA, GHA , Riyadh, Feb 2013

[Eur J Cardiothorac Surg. 2012 Aug 11. [Epub ahead of print

Transapical aortic valve replacement in extreme-risk patients: .outcome, risk factors and mid-term results

.Ferrari E, Namasivayam J, Marcucci C, Gronchi F, Berdajs D, Niclauss L, von Segesser LK

( extreme-risk' patients underwent transapical TAVR (TA-TAVR '40 (. EuroSCORE above 35%) , Variables were analysed as risk factors for hospital and mid-term mortality .and a 2-year follow-up (FU) was obtained Mean FU time was 24 months: actuarial survival estimates for all-cause mortality at 6 months, 1 year, 18 months and 2 years were 68, 57, 54 and .54%, respectively

:CONCLUSIONS TA-TAVR in extreme-risk patients carries a moderate risk of hospital mortality.

Severe comorbidities and presence of residual paravalvular leakages affect the mid-term survival, whereas surviving patients have an acceptable quality of life .without rehospitalizations for cardiac decompensation SHA, GHA , Riyadh, Feb 2013

CLINICAL RESEARCH

European Heart Journal (2010) 31, 1398–1403 doi:10.1093/eurheartj/ehq060

Valvular heart disease

Transapical aortic valve implantation in 100 consecutive patients: comparison to propensitymatched conventional aortic valve replacement Thomas W alther 1,* , Gerhard Schuler 2, Michael A. Borger 1, Jo¨rg Kempfert 1, Jo¨ rg Seeburger 1, Yvonne Ru¨ckert 1, Jo¨rg Ender 3, Axel Linke 2, Markus Scholz 4, Volkmar Falk 1, and Friedrich W . Mohr 1 1

Department of Cardiac Surgery, Heartcenter, University Leipzig, Herzzentrum, Klinik fu¨r Herzchirurgie, Stru¨mpellstrasse 39, Leipzig 04289, Germany; 2 Department of Cardiology, 3

4

Epidemiology, Leipzig, Germany Received 14 July 2009; revised 15 December 2009; accepted 19 January 2010; online publish-ahead-of-print 16 March 2010

A im s To evaluate the outcome of transapical aortic valve implantation (TA-AVI) in comparison to conventional surgery. .....................................................................................................................................................................................

Met hods One hundred consecutive high-risk patients with symptomatic aortic valve stenosis received TA-AVI using the and r esult s Edwards SAPIEN TM pericardial xenograft between February 2006 and January 2008. Patient age was 82.7+ 5 years, 77 were females, logistic EuroSCORE predicted risk of mortality was 29.4+ 13% and Society Thoracic Surgeons score risk for mortality was 15.2+ 8.3%. Propensity score analysis was used to identify a control group of patients that underwent conventional aortic valve replacement (C-AVR). Transapical aortic valve implantation was performed successfully in 97 patients, whereas three patients required early conversion. There were no new onset neurological events in the TA-AVI group and early extubation was performed in 82 patients. Echocardiography revealed good valve function with low transvalvular gradients in all patients. Thirty-day survival was 90+ 3 vs.

85+ 4% for TA-AVI vs. C-AVR, and 1-year survival was 73+ 4 vs. 69+ 5%(P¼ 0.55). .....................................................................................................................................................................................

Conclusion Transapical aortic valve implantation is a safe, minimally invasive, and off-pump technique to treat high-risk patients with aortic stenosis. Results of the initial 100 patients are good and compare favourably to conventional surgery.

----------------------------------------------------------------------------------------------------------------------------------------------------------Keywords

Aortic valve † Aortic stenosis † Transcatheter † Transapical aortic valve implantation † Aortic valve replacement

: CONCLUSION  TA-AVI is a feasible technique for high risk AS

WHENEVER THE VASCULAR ACCESS IS DIFFICULT, with high success rate and acceptable complications.

 Long term results and Survival benefits still to

be determined.

SHA, GHA , Riyadh, Feb 2013