Experience with 500 Stentless Aortic Valve Replacements

Dimitrios C. Iliopoulos, MD

Cardiac Surgeon

Ass. Professor of Surgery

University of Athens, School of Medicine

I declare no conflict of interest

Burden of Valve Disease in the US

Year 2000 ➔ 2030

Disease

AS 2.5 millions ➔ 4.6 millions MR 2.7 millions ➔ 4.8 millions

Stentless Aortic Valves Ideal for:

• Patients > 60 years old

• Patients < 60 years old with ↑ risk of thromboembolism

• Small annulus

• Concomittant procedures (↓ cross – clamp time)

Freedom SOLO • Superior haemodynamics

• Faster to implant (one suture line)

• Maximization of flow in small annuli

• Outflow side already scalloped

• May avoid annulus enlargement

• No fabric reinforcement

• Soft and pliable tissue

• Detoxified valve and ready for use

• Expected reduction of calcification

• Clinically proven design

(18 yrs of Pericarbon stented model and

10 yrs of stentless) Native at Heart

Different Implant Techniques

Outflow suture line

Freedom SOLO: Technique

Supra-Annular

• No material within the annulus

• 100% orifice-to-annulus ratio

Implant Technique: Suturing

Suggested order

• Each suture is tied at the midpoint

• Running suture from the midpoint to the top of the post, taking large bites

Implant Technique: Suturing

• Once at the top, each suture is passed through the patient aortic wall

• Adjacent sutures are then tied

Our published initial experience…

128 patients

Protocol

500 patients undergoing AVR with SOLO Freedom aortic valve ± Concomitant procedures

U/S: preoperatively, immediate – 3 months – 6 months – 12 months postoperatively

Mean follow up: 57 months

Patient Demographics

Age (y) 78.5±4.4

Gender (M:F) 271:229

BSA, mean±SD 1.8±0.17

NYHA, mean±SD 2.3±0.8

I-II, n(%) 379 (76)

III-IV, n(%) 121 (24)

Euroscore II, mean±SD 9.04±2.7

High Euroscore Patients, n(%) 410 (82)

AV Pathology: Stenosis

3%

24%

73%

Mild

Moderate

Severe

Valves Pathology

Aortic Valve (%) Mitral Valve (%)

AV Regurgitation 21.1 MV Stenosis 9

Mixed Lesion 18.2

MV

Regurgitation 48.5

BAV 2.7 Mixed Lesion 3

Endocarditis 3

Risk factors

Comorbidities (%)

CAD 45.5

Hypertension 75.8

DM 42.2

Renal dysfunction 12.1

Dyslipidemia 36.4

Pulmonary hypertension 12.1

AFib 27.3

Previous Cardiac Surgery (%)

CABG 6

AVR 6

Pre-op Medication Drug Treatment (%)

Beta Blockers 73

ACE Inhibitors 39

AT Inhibitors 12

Diuretics 55

Digoxin 6

Calcium Channel Blockers

6

Statins 27

ASA 24

Clopidogrel 12

Coumadin 18

Laboratory Work-up

Pre-op Work-up, mean±SD

Hemoglobin 12.4 ± 1.7 HCT 38.3 ± 5 RBC 4471562 ± 726933 PLT 200250 ± 50211

Post-op Work-up, mean±SD

min Hgb 9.2 ± 0.9 min HCT 27.9 ± 2.9 min RBC 3215312 ± 378519 min PLT 65219 ± 31322 Post-op Day 3.7 ± 1.4

Significantly lower in all cases

Size of prosthesis

0

10

20

30

40

50

60

70

80

21mm 23mm 25mm 27mm

SOLO Freedom

Intra-operative data

Transfusion, mean±SD FFP 3.9 ± 2 RBC 2.8 ± 1.6 PLT 2.9 ± 3.8

Cross-clamp time (min), mean±SD 89 ± 30 CBP time (min), mean±SD 121 ± 38 SOLO time (min), mean±SD 42.7 ± 12.4

Concomitant Operation, (%) CABG 30 MVR 21 Other 18

Solely AVR only in the 40% of the patients !!

Post-operative data

ICU Stay (h), mean±SD 68 ± 17 Hospital Stay (d), mean±SD 8.3±2.7

In-hospital mortality (%) 4.2 Time to death (d), mean±SD 7.2±11.2 Cause of death, % Cardiogenic shock 33 Bleeding 33 Infection 33 Re-operation (%) 2 Reason for re-op (%) Bleeding 100

All patients had high Euroscore II

U/S Data

Preoperative Postoperative 3m 6m 12m p-value

LVEDD (mm) 51.2 ± 8.23 48.4 ± 5.8 47.3 ± 7.5 46.3 ± 6.4 45.5 ± 7.9 ns

LVESD (mm) 34.3 ± 7.9 32.4 ± 8.2 31.1 ± 8.2 30.3 ± 5.8 30.1 ± 8.7 ns

IVS(mm) 12.3 ± 2.1 12.4 ± 1.9 10.3 ± 1.3 10.4 ± 1.5 10.1 ± 1.3

0

10

20

30

40

50

60

Preoperative Postoperative 3m 6m 12m

LV End-diastolic Diameter (mm)

0

5

10

15

20

25

30

35

40

45

Preoperative Postoperative 3m 6m 12m

LV End-systolic Diameter (mm)

0

2

4

6

8

10

12

14

Preoperative Postoperative 3m 6m 12m

Intra-ventricular Septum (mm)

p

0

2

4

6

8

10

12

14

Preoperative Postoperative 3m 6m 12m

Posterior Wall (mm)

0

20

40

60

80

100

120

Preoperative Postoperative 3m 6m 12m

Peak Gradient (mmHg)

p

0

10

20

30

40

50

60

70

Preoperative Postoperative 3m 6m 12m

Mean Gradient (mmHg)

p

0

1

2

3

4

5

6

Preoperative Postoperative 3m 6m 12m

Peak Velocity (cm/sec)

p

Post-op AV Regurgitation

Postoperative 3 months 6 months 12 months

Relative frequency (%)

1,6 2,2 1 1

Mean Grade

1 1 1 1

Type Left Sinus Of Valsalva

Left Sinus of Valsalva –

Paravalvular

Left Sinus Of Valsalva

Left Sinus Of Valsalva

Kaplan-Meier Analysis

Mortality Hazard

Surgical tips for easy implantation

Use 4-0 for thick or 5-0 prolene for thin aortic wall Oversize the aortic root (1 or 2 size bigger) Do not hesitate to stabilize the valve with external pledgeted sutures (especially

after local decalcification) Do not hesitate to implant in calcified roots (local decalcification) 1-2 mm higher in non-coronary sinus to avoid prosthetic aortic valve replacement

insufficiency Be flexible:

no one root is perfectly symmetrical modify the implantation

Take-home message

Easy and fast implantation

Ideal for small annulus

Excellent Hemodynamics

Earlier Left Ventricular Reverse Remodelling

Thank you !