tavi,transcatheter aortic valve replacement, tavi,tavr,

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AORTIC STENOSIS

Severe symptomatic aortic stenosis carries a poor prognosis. Surgical aortic valve replacement has been the standard of care in adults with severe symptomatic AS. The risks associated with surgical aortic valve replacement are increased in: (High Risk Population)

Elderly patients: + Following Co Morbidity Severe systolic heart failure CVD CAD PVD CKD Ch respiratory dysfunction.

Transcatheter aortic valve implantation(TAVI) has been developed as an alternative to the surgical approach in high-risk population.

Dr. Alain Cribier..

TAVIMore than 30,000 patients with severe symptomatic aortic stenosis considered high risk for surgery have undergone the treatment. This technique is still in its early stages, but rapidly growing evidence has been developed through observational studies, national and device-specific registries,and randomizedclinical trials.

Indication:Currently, there are no established indications or guidelines for TAVR in the United States. Indications are based on following trial and consensus. PARTNER Trial - Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.N Engl J Med. 2010 Oct 21. 363(17):1597-607. ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement.J Am Coll Cardiol. 2012 Mar 27. 59(13):1200-54.

Indication No 1: Patients with calcific aortic valve stenosis with the following echocardiographic criteria:

Mean gradient greater than 40 mm Hg or jet velocity more than 4 m/s and an initial aortic valve area (AVA) of less than 0.8 cm2or indexed effective orifice area (EOA) of less than 0.5 cm2/m2;

Qualifying AVA baseline measurement must be within 45 days of the date of the procedure

Indication No 2: One cardiac interventionalist and 2 experienced cardiothoracic surgeons agree that medical factors either preclude operation or are high risk for surgical aortic valve replacement, based on a conclusion that the probability of death or serious irreversible morbidity exceeds the probability of meaningful improvement. The surgeons' consult notes shall specify the medical or anatomic factors leading to that conclusion and include a printout of the calculation of the Society of Thoracic Surgeons (STS) score to additionally identify the risks in the patient; at least 1 of the cardiac surgeon assessors must have physically evaluated the patient

Indication No 3: Patient is deemed to have symptomatic aortic valve stenosis, as differentiated from symptoms related to comorbid conditions and as demonstrated by New York Heart Association (NYHA) functional class II or greater.

In the European Union, Transcatheter Aortic Valve Implantation is performed in patients with severe aortic stenosis who are high-risk surgical candidates with a logistic EuroScore of more than 20% and in patients who have a contraindication to surgical aortic valve replacement.

Contraindications and exclusion criteria for TAVI are as follows: Evidence of an acute MI at 1 month or less before the intended treatment (defined as Q-wave MI, or nonQ-wave MI with CK-MB twice normal in the presence of MB elevation and/or troponin level elevation [WHO definition].

Contraindications.

Aortic valve is a congenital unicuspid or congenital bicuspid valve or is noncalcified.Mixed aortic valve disease ( AS+ AR) with predominant AR (>3+).Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of screening evaluation.

Contraindications.Need for emergency surgery for any reasonHOCM with or without obstruction.Severe left ventricular dysfunction with LVEF of less than 20%.Severe pulmonary hypertension RV dysfunction.Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.

ContraindicationsA known contraindication or hypersensitivity to all anticoagulation regimens or an inability to undergo anticoagulation for the study procedure.Native aortic annulus smaller than 18 mm or larger than 25 mm as measured with echo.MRI-confirmed stroke or TIA within 6 months (180 days) of the procedure.

ContraindicationsEstimated life expectancy of less than 12 months due to noncardiac comorbid conditions.Severe incapacitating dementia.Severe MR. Renal insufficiency (creatinine level >3 mg/dL) and/or end-stage renal disease requiring chronic dialysis at the time of screening.

Contraindications:

Significant aortic disease, including abdominal aortic or thoracic aortic aneurysm defined as a maximal luminal diameter of 5 cm or greater, marked tortuosity, atheroma or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta.

Severe "unfolding" and tortuosity of the thoracic aorta.

Aortic RegurgitationAR is typically paravalvular mild or mild-moderate severityMost AR disappears or reduces at 1 yr follow-up.

Embolic protection device

Left main coronary artery occlusion resulting from a bulky leaflet displaced over the ostium. Successful percutaneous intervention restored left coronaryflow.

The principal transcatheter aortic valve implantation devices currently in use:(A) Edwards Sapien XT bioprosthesis and(B) Medtronic CoreValve bioprosthesis

Implanted since 2002Transfemoral, transapical, alternate access routesBovine pericardium leafletsCobalt-chromium balloon expandable stentAnnular fixationSub coronary implant

Edwards Sapien Valve

Medtronic CoreValvePenrose program was the first CoreValve program in CO, NM, UT, WYRetrograde approach onlyEquine Pericardium LeafletsNitinol Self-ExpandingAnnular and Supra-coronary fixation18fr delivery systemOffers a 31mm valve size

TAVI PROCEDURE

Conclusion.Catheter based treatment of aortic stenosis is improving.Restenosis after valvuloplasty has been overcome after development of TAVI.Indications for TAVI can be expanded after the availability of follow up of patients of the cohort.Team approach is essential for successful procedure.Training required for performance of TAVI and dedicated imaging instruments.Patient selection is complex.

Advancing TAVI, changing lives what have we learned after 10 years

Prof. Dr. med. Christian Hengstenberg

University Hospital Regensburg, Germany

Advancing TAVI, changing lives what have we learned after 10 years

Population needs, growing proportion of elderly patients, developments in surgery

TAVI patients: previously not operated on

Advances in Team: the Regensburg experience

Technology for access route, sizing: 3D-TEE, MSCT

Optimal setting: hybrid operation theatre

Valve and delivery systems, new valves

Strategy

Development of population in Germany from 1910 to 2060

Heart valve disease will be

an important issue for the

future!

1910 1950 2008 2060

Cardiac surgery in over 70

year old patients

1994-2010

Age structure in patients with cardiac surgery

Isolated bypass graftings 1994-2010

- 5% / year

Surgical intervention should

be performed

promptly once

even minor

symptoms occur

Ross J Jr, Circulation 1968;38 (Suppl 1)

C.M. Otto. Heart 2000

Prognosis of severe aoric stenosis

Charlson E et al. J Heart Valve Dis2006;15:312-321,

Iung B et al. European Heart Journal 2003;24:1231-1243

Bouma B J et al. Heart 1999;82:143-148

EU US

40

68 59

60

32 41

0%

25%

50%

75%

100%

Charlson

2006

Lung 2003 Bouma 1999

Untreated

Surgically Treated

Many older patients with severe and symptomatic AS are not treated yet!

Isolated aortic valve replacement Germany 2000-2010

TAVI

SAVR

TAVI

SAVR

Isolated aortic valve replacement The Regensburg numbers

50% transfemoral

50% transapical

Transcutanous aortic valve implantation (TAVI) two different systems

Edwards Sapien XT Transfemoral, transapical

Ballon expanding, bvine pericardium

CoreValve-Medtronic transfemoral

Self expanding, pocine pericardium

Advances in the team Learning curve of Regensburg

Advances in technology - access route 3D reconstruction of multisclice CT

9,6 mm

8 mm

Advances in technology distance of coronary ostium in MSCT

Advances in technology Optimal sizing of prothesis

Aorten-Annulus in PLAX (sagittal):

2D-TEE:

3D-TEE:

MSCT:

Advances in technology Optimal sizing of prothesis 2D-TEE

20 mm

Advances in technology Optimal sizing of prothesis 3D-TEE

19,6 mm

Advances in technology Optimal sizing of prothesis MSCT

sagittal: 19,4 mm

coronary: 25,0 mm

Advances in technology Optimal sizing of prothesis results

14.3 mm

Aortic annulus in PLAX (sagittal): 2D-TEE 20,0 mm 3D-TEE 19,6 mm MSCT 19