TAVI procedures with combined Sapien and CoreValve prosthesis:

early experience in a single Center

Gian Luca Martinelli MDCV Surgery Dept.

S Anna Hospital – Catanzaro - Italy

Yes

Femoral Access

Evaluation Y/N

Femoral Access

Evaluation Y/N

Yes No No

Not in Study

Transfemoral VS

1:1 Randomization

1:1 Randomization

1:1 Randomization

Transfemoral

Medical Management ControlVS

Cohort B

Yes

No

AVR Control

Trans apical

AVR Control

OPERABLEASSESMENT

VS

Cohort A ~650 pts ~350 pts

Yes

Femoral Access

Evaluation Y/N

Femoral Access

Evaluation Y/N

Yes No No

Not in Study

Transfemoral VS

1:1 Randomization

1:1 Randomization

1:1 Randomization

Transfemoral

Medical Management ControlVS

Cohort B

Yes

No

AVR Control

Trans apical

AVR Control

OPERABLEASSESMENT

VS

Cohort A ~650 pts ~350 pts

• Fully enrolled. • 1st results by Q4-2010

PARTNER IDEThe world’s first and only prospective, multicenter, randomized clinical trial to

compare transcatheter heart valve replacement to conventional AVR and medicalmanagement.

Primary endpoint: one year survival plus extensive 5-year follow-up

Indications to TAVI procedure at S.Anna Hospital

Symptomatic Severe Aortic Stenosis

• Operative High Risk scores ( logES > 20%)

• Controindications to open surgery

• More recently, age over 80.

129129 patients were submitted to TAVIprocedure between 2010/2011

Patients CharacteristicsVariable TAVI ( N= 129)

Age, y 80,4 ± 5.5

Female gender, n(%) 76( 58.4%)

NYHA class 3.2 ± 0.5

IMA n(%) 58(45%)

Neurological dysfuction or stroke n(%) 36(28%)

Chronic Kidney failure n(%) 29(23%)

COPD n(%) 60(47%)

Liver cirrosis 10(8%)

Previous open heart surgery n(%) 9 (6.9)

Previous PCI n(%) 13 (10.7)

Previous PMK implantation n(%) 14(11%)

Atrial Fibrillation, n(%) 5(4%)

Logistic Euroscore, % 22.3 ± 11

VASCULAR ACCESSSapien100 and CoreValve 29

75% of cases in general anesthesia

Transfemoral 98

Transaortic 3

Transapical 28

Early results

• Global In-hospital Mortality : 13/129 (10.1%)

• 5 related to the procedure (aortic dissection, anulus rupture, occlusion of right coronary, 2 embolizations)

• 2 Low Cardiac output

• 2 ARDS

• 2 MOF

• 1 ICH

• 1 GI bleeding

Early results according to vascular access

• In-hospital Mortality (TF approach): 5/98 (5.1%)• mean LogES: 20.4. ± 12.8%

• mean LogES ( death group) 35.3 ± 28.3%

• In-hospital Mortality (TA approach): 7/28 (25%)• mean LogES: 26.1 ± 14.4%

• mean LogES ( death group) 38.7 ± 18.5%

Perioperative Complications

• 5 cases of conversion to AVR ( only 1 death): • 1 Embolization into the Aorta

• 2 Embolization into the Ventricular Cavity

• 1 Residual Severe AR

• 1 Rupture on Non Coronary Sinus

• IMA 2 pts (1.5%)

• Stroke: 2 pts (1.5%)

• Major Vascular complication: 6 pts (4.6%)

• Minor Vascular complications: 6 pts (4.6%)

• Acute Renal Failure (VARC) 9 pts (6.9%)

• PMK implantation 8 pts ( 6.2%)

SURVIVAL (Kaplan-Meyer Method)Follow-up: 9.9 ± 7 mth

Late Death: 9 pts1 Cardiac related8 Non Cardiac related

2 late reoperations:1 endocarditisSevere AR in valve in valve with bioprosthetic failure

9.5 + 3.1

EF>50

30>EF>50

EF<30

EF>50

30>EF>50

EF<30

EF>50

30>EF>50

EF<30

At Fup, only 1 pt has more than AR > 2

p<0.01

p=0.2p<0.01

p=0.3

p<0.01p=0.2

p<0.01

p=0.1

Goal of the procedure

Reduction of AR after 30 min

Valve in Valve

Treatment of AR>2+ after procedure

• Valve in valve

• BAV

• Repositioning of prosthesis

• AVR

Prosthesis Embolization

Embolia in ventricolo (spina)

Prosthesis Embolization

Prosthesis Embolization

Coronary occlusion

Coronary occlusion

Successful THV PROGRAM

Patient-Focused Multidisciplinary Heart ValveTeam Approach

RadiologistRadiologist

EchocardiographistEchocardiographist

CardiologistCardiologistCardiac SurgeonCardiac Surgeon

AnesthesiologistAnesthesiologist

Excellent Visualization

Patient Selection

Patient Management

Procedure Planning

Hybrid Suite

TAVI is an approachto the patient….

not just a procedure

Conclusion

THANK YOU

Late Endocarditis

Treatment of bioproshesis degeneration: the role of TAVI

Role of TAVI in isolated AR

Eco pre e post impianto di Attanasio su centricity redux di TD

Multidisciplinary Imaging Approach

Between Dec 2010 and Jan 2012

325 patients were treated for isolated AS.

129129 patients were submitted to TAVIprocedure

Sapient XT(77.5%)

CoreValve(22.5%)

TF

TA

TAo

TF

TAo

75% in general anesthesia

Operative Data70

28

2

28

1