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 Native at Heart 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)
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
High Euroscore Patients, n(%) 410 (82) 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
AV Pathology: Stenosis 3% 73% 24% 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
Pre-op Medication Drug Treatment (%) Beta Blockers 73 ACE Inhibitors 39 AT Inhibitors 12 Diuretics 55 Digoxin 6 Calcium Channel Blockers Statins 27 ASA 24 Clopidogrel 12 Coumadin 18 6
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 Significantly lower in all cases 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
Size of prosthesis 80 SOLO Freedom 70 60 50 40 30 20 10 0 21mm 23mm 25mm 27mm
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 <0,05 PW (mm) 11.1 ± 1.4 10.9 ± 1.8 10.7 ± 1.1 10.4 ± 1.1 10.2 ± 1.4 ns Peak Gradient (mmhg) 68.9 ± 27.6 15.4 ± 7.6 15.8 ± 7.1 15.6 ± 6.5 15.2 ± 8.1 <0,001 Mean Gradient (mmhg) 45.3 ± 17.8 10.1 ± 6.6 10.2 ± 2.7 10.1 ± 1.7 10 ± 1.1 <0,001 Peak Velocity (cm/sec) 4.1 ± 0.9 1.7 ± 0.8 1.8 ± 0.8 1.8 ± 0.5 1.7 ± 0.4 <0,001
60 LV End-diastolic Diameter (mm) 50 40 30 20 10 0 Preoperative Postoperative 3m 6m 12m
45 40 35 30 25 20 15 10 5 0 LV End-systolic Diameter (mm) Preoperative Postoperative 3m 6m 12m
14 Intra-ventricular Septum (mm) 12 10 p<0.05 8 6 4 2 0 Preoperative Postoperative 3m 6m 12m
14 Posterior Wall (mm) 12 10 8 6 4 2 0 Preoperative Postoperative 3m 6m 12m
120 Peak Gradient (mmhg) 100 80 p<0.001 60 40 20 0 Preoperative Postoperative 3m 6m 12m
70 Mean Gradient (mmhg) 60 50 p<0.001 40 30 20 10 0 Preoperative Postoperative 3m 6m 12m
6 Peak Velocity (cm/sec) 5 p<0.001 4 3 2 1 0 Preoperative Postoperative 3m 6m 12m
Post-op AV Regurgitation Postoperative 3 months 6 months 12 months Relative frequency (%) Mean Grade 1,6 2,2 1 1 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!