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 resultsDOMENICO PALOMBOVascular and Endovascular UnitIRCCS San Martino University Hospital - IST GenoaUniversity of Genoa
3 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.
10 Our studyCAROTID 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 Our study Technically challenging? Shunting more difficult? Worst end-point visualization?Longer operating and clamping time?Lower re-stenosis rate?
12 ObjectiveOUR STUDYThe 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 techniqueVERSUSSecond group eversion Etheredge technique
13 ObjectiveOUR STUDYThe 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.
14 Materials and Methods Inclusion criteria: Patients older than 50 years Planned admission to our ward to undergo carotid endarterectomyOUR STUDY
15 Materials and Methods Exclusion criteria: Restenosis Hostile neck Anatomical features :Kinking of internal carotid arteryHigh carotid artery bifurcationOUR STUDY
16 Materials and Methods TYPE OF TREATMENT OUR STUDY All the patients were administered apreoperatory duplex ultrasound of theCarotid Arteries, in order to establish thefeasibility of both surgeries. Once thepatient was deemed fit for the enlistment,he/she was random assigned to one of thetwo groupsTYPE OF TREATMENTEversion endarterectomyAccording to DeBakeyEversion endarterectomyAccording to Etheredge
17 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 dataFollow up: clinical dataFollow up: tecnical dataOUR STUDY
18 Materials and Methods RESTENOSIS DEGREE: <50% mild OUR STUDYRESTENOSIS DEGREE:<50% mild≥50%-70% moderate70% a99% seriousReintervention: restenosis >80%This evaluation has been made with duplex ultrasound, using the ECST parameters, and correlating this measurements with PSV
19 Materials and MethodsTo 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 ENLIST136 each group.A total of 272 patients to enlistOUR STUDY
20 Materials and Methods Surgical Procedure General Anesthesia Stump Pressure CheckCerebral/Somatic Oximeter (INVOS)Quality control with duplex ultrasound intraoperatively after surgeryOUR STUDY
21 Materials and Methods Technically challenging? Shunting more difficult?Worst end-point visualization?Longer operating and clamping time?Lower re-stenosis rate?
22 Preliminary Results January 2010- October 2013 A total of 272 patients to enlistPatients Enlisted 254254135119
23 * Pz with stroke or tia within 6 months before surgery Preliminar Results January October 2013EVERSION DeBakeyPATIENTS 135EVERSION EtheredgePATIENTS 119FEMALE31,9%25,2%MALE68,1%74,8%EVERSION DeBakeyPATIENTS 135EVERSION EtheredgePATIENTS 119SYMPTOMATIC *8,9%10,1%ASYMPTOMATIC91,1%89,9%* Pz with stroke or tia within 6 months before surgery
24 Mean duration of clamping (min) Preliminary Results January October 2013Surgery dataEVERSION DeBakeyEVERSION EtheredgepMean duration of clamping (min)43,9444,74Shunt (%)4,4%1,6%0 , 8 (N.S.)Stump pressure: > or < mmHg
25 Preliminary Results January 2010- October 2013 Difference in shunt use for De Bakey eversion vs Etheredge eversion was not statistically significant.
26 Morbi-mortality and major neurological complication Preliminary Results January October 2013Morbi-mortality and major neurological complication30 DAYSDE BAKEY EVERSION GROUP PZ1 Cerebral hyperperfusion syndrome (0,9%)1 Stroke (0,9%)1 Respiratory distress syndrome (0,9%)ETHEREDGE EVERSION GROUP PZnoneDifference in morbi-mortality and major complications of DeBakey eversion vs Etheredge was not statistically significant.
27 Preliminary Results January 2010- October 2013 Re-stenosi > 70 %12-month follow-up on 205 patientDBET12 Months4 (3,79%)3 (2,66%)n.s
28 Overall number of patient re-treated at 12 months FU Preliminary Results January October 201312-month follow-up on 205 patientIndication to treatment if re-stenosis > 80%3 patients re-treated6 months2 patients re-treated12 monthsOverall number of patient re-treated at 12 months FU5 pt
29 Preliminary Results January 2010- October 2013 Results showed:Technical feasibilityComparable morbi-mortality rateComparable restenosis rateComparable operating time
30 Not be the first to use the new, Not be the last to leave the old Pope Alessandro VIII