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Perspective randomized study on eversion carotid endarterectomy : DeBakey-Van Maele technique vs Etheredge technique. Preliminary results DOMENICO PALOMBO.

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Presentation on theme: "Perspective randomized study on eversion carotid endarterectomy : DeBakey-Van Maele technique vs Etheredge technique. Preliminary results DOMENICO PALOMBO."— Presentation transcript:

1 Perspective randomized study on eversion carotid endarterectomy : DeBakey-Van Maele technique vs Etheredge technique. Preliminary results DOMENICO PALOMBO Vascular and Endovascular Unit IRCCS San Martino University Hospital - IST Genoa University of Genoa

2 INTRODUCTION

3 reduced incidence of restenosis in the group receiving EA for eversion, without finding differences in the incidence of stroke during follow up. 1) Cao P. et al. Eversion versus conventional carotid endarterectomy for preventing stroke (review). The Cochrane Library 2009 issue 4. Surgical techniques INTRODUCTION But which technique for the eversion?

4 Restenosis Follow-up INTRODUCTION

5 Endarterectomy according De Bakey (EDB) INTRODUCTION

6

7 Endarterectomy according Etheredge (EE) INTRODUCTION

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9 Which Eversion endarterectomy: ? INTRODUCTION EEEDB

10 Our study CAROTID SURGERY A COMPARISON BETWEEN TWO TECHNIQUES A RANDOMIZED PROSPECTIVE STUDY ON RESTENOSIS RATE Domenico Palombo Vascular and Endovascular Unit A.O.U. San Martino – IST Genova Unviversity of Genova

11 Technically challenging? Shunting more difficult? Worst end-point visualization? Longer operating and clamping time? Lower re-stenosis rate? Our study

12 Objective The primary aim of our study is to evaluate and compare the rate of carotid restenosis between two groups of patients that underwent Eversion Endarterectomy. First group eversion DeBakey technique VERSUS Second group eversion Etheredge technique OUR STUDY

13 Objective The secondary aim of our study is to evaluate and compare the rate of morbi-mortality and major neurological complications between two groups of patients that underwent Eversion Endarterectomy. OUR STUDY

14 Inclusion criteria: Patients older than 50 years Planned admission to our ward to undergo carotid endarterectomy Materials and Methods OUR STUDY

15 Exclusion criteria: Restenosis Hostile neck Anatomical features : Kinking of internal carotid artery High carotid artery bifurcation Materials and Methods OUR STUDY

16 All the patients were administered a preoperatory duplex ultrasound of the Carotid Arteries, in order to establish the feasibility of both surgeries. Once the patient was deemed fit for the enlistment, he/she was random assigned to one of the two groups TYPE OF TREATMENT Eversion endarterectomy According to Etheredge Eversion endarterectomy According to DeBakey Materials and Methods OUR STUDY

17 Personal Data Case history data Perioperatory clinical data: about the state of neck blood vessels (evaluation of near-occlusion/ occlusion or kinking of vertebral and carotid arteries of both sides), possible cerebral symptoms (TIA, amaurosis, stroke), about the surgery (stump pressure, duration of clamping, possible use of shunt, monitoring of blood pressure) Post-operatory clinical data Follow up: clinical data Follow up: tecnical data Materials and Methods OUR STUDY

18 RESTENOSIS DEGREE: <50% mild ≥50%-70% moderate 70% a99% serious Reintervention: restenosis >80% This evaluation has been made with duplex ultrasound, using the ECST parameters, and correlating this measurements with PSV Materials and Methods OUR STUDY

19 To calculate the required number of patients it was used the Chi-square statistical test (alfa 0.05, power 80%). The statistical formula used is Pocock’s. NUMBER OF SUBJECTS TO ENLIST 136 each group. A total of 272 patients to enlist Materials and Methods OUR STUDY

20 Surgical Procedure General Anesthesia Stump Pressure Check Cerebral/Somatic Oximeter (INVOS) Quality control with duplex ultrasound intraoperatively after surgery Materials and Methods OUR STUDY

21 Technically challenging? Shunting more difficult? Worst end-point visualization? Longer operating and clamping time? Lower re-stenosis rate? Materials and Methods

22 Preliminary Results January 2010- October 2013 Patients Enlisted 254 A total of 272 patients to enlist 254 135 119

23 Preliminar Results January 2010- October 2013 EVERSION DeBakey PATIENTS 135 EVERSION Etheredge PATIENTS 119 FEMALE31,9%25,2% MALE 68,1%74,8% EVERSION DeBakey PATIENTS 135 EVERSION Etheredge PATIENTS 119 SYMPTOMATIC *8,9%10,1% ASYMPTOMATIC91,1%89,9% * Pz with stroke or tia within 6 months before surgery

24 Preliminary Results January 2010- October 2013 Surgery data EVERSION DeBakey EVERSION Etheredge p Mean duration of clamping (min) 43,9444,74 Shunt (%)4,4%1,6%0, 8 (N.S.) Stump pressure: > or < 35 mmHg

25 Difference in shunt use for De Bakey eversion vs Etheredge eversion was not statistically significant. Preliminary Results January 2010- October 2013

26 Morbi-mortality and major neurological complication 30 DAYS DE BAKEY EVERSION GROUP 135 PZ 1 Cerebral hyperperfusion syndrome (0,9%) 1 Stroke (0,9%) 1 Respiratory distress syndrome (0,9%) ETHEREDGE EVERSION GROUP 119 PZ none Preliminary Results January 2010- October 2013 Difference in morbi-mortality and major complications of DeBakey eversion vs Etheredge was not statistically significant.

27 Preliminary Results January 2010- October 2013 DB ET 12 Months4 (3,79%) 3 (2,66%)n.s Re-stenosi > 70 % 12-month follow-up on 205 patient

28 3 patients re-treated 6 months 12 months2 patients re-treated 12-month follow-up on 205 patient Preliminary Results January 2010- October 2013 Indication to treatment if re-stenosis > 80% Overall number of patient re-treated at 12 months FU 5 pt

29 Preliminary Results January 2010- October 2013 Results showed: Technical feasibility Comparable morbi-mortality rate Comparable restenosis rate Comparable operating time

30 Not be the first to use the new, Not be the last to leave the old Pope Alessandro VIII

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