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

INTRODUCTION

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

INTRODUCTION Restenosis Follow-up

Endarterectomy according INTRODUCTION Endarterectomy according De Bakey (EDB)

INTRODUCTION

Endarterectomy according Etheredge (EE) INTRODUCTION Endarterectomy according Etheredge (EE)

INTRODUCTION

Eversion endarterectomy: INTRODUCTION Which Eversion endarterectomy: ? EDB EE

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

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

Objective OUR STUDY 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

Objective OUR STUDY 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.

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

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

Materials and Methods TYPE OF TREATMENT OUR STUDY 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 DeBakey Eversion endarterectomy According to Etheredge

Materials and Methods 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 OUR STUDY

Materials and Methods RESTENOSIS DEGREE: <50% mild OUR STUDY 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 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 OUR STUDY

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

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

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

* Pz with stroke or tia within 6 months before surgery Preliminar Results January 2010- October 2013 EVERSION DeBakey PATIENTS 135 EVERSION Etheredge PATIENTS 119 FEMALE 31,9% 25,2% MALE 68,1% 74,8% EVERSION DeBakey PATIENTS 135 EVERSION Etheredge PATIENTS 119 SYMPTOMATIC * 8,9% 10,1% ASYMPTOMATIC 91,1% 89,9% * Pz with stroke or tia within 6 months before surgery

Mean duration of clamping (min) Preliminary Results January 2010- October 2013 Surgery data EVERSION DeBakey EVERSION Etheredge p Mean duration of clamping (min) 43,94 44,74 Shunt (%) 4,4% 1,6% 0 , 8 (N.S.) Stump pressure: > or < 35 mmHg

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

Morbi-mortality and major neurological complication Preliminary Results January 2010- October 2013 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 Difference in morbi-mortality and major complications of DeBakey eversion vs Etheredge was not statistically significant.

Preliminary Results January 2010- October 2013 Re-stenosi > 70 % 12-month follow-up on 205 patient DB ET 12 Months 4 (3,79%) 3 (2,66%) n.s

Overall number of patient re-treated at 12 months FU Preliminary Results January 2010- October 2013 12-month follow-up on 205 patient Indication to treatment if re-stenosis > 80% 3 patients re-treated 6 months 2 patients re-treated 12 months Overall number of patient re-treated at 12 months FU 5 pt

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

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