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

results

DOMENICO PALOMBOVascular and Endovascular Unit

IRCCS San Martino University Hospital - IST GenoaUniversity of Genoa

INTRODUCTION

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?

Restenosis Follow-up

INTRODUCTION

Endarterectomy according De Bakey (EDB)

INTRODUCTION

INTRODUCTION

Endarterectomy according Etheredge (EE)

INTRODUCTION

INTRODUCTION

Which Eversion endarterectomy:

??

INTRODUCTION

EEEDB

Our study

CAROTID SURGERYCAROTID SURGERYA COMPARISON BETWEEN A COMPARISON BETWEEN

TWO TECHNIQUESTWO TECHNIQUES

A RANDOMIZED PROSPECTIVE A RANDOMIZED PROSPECTIVE STUDY ON RESTENOSIS RATE STUDY ON RESTENOSIS RATE

Domenico Palombo Domenico Palombo Vascular and Endovascular UnitVascular and Endovascular UnitA.O.U. San Martino – IST GenovaA.O.U. San Martino – IST Genova

Unviversity of GenovaUnviversity of Genova

Technically challenging?Shunting more difficult?

Worst end-point visualization?Longer operating and clamping time?

Lower re-stenosis rate?

Our study

ObjectiveObjective

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

OUR STUDY

ObjectiveObjective

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

OUR STUDY

Inclusion criteria:

Patients older than 50 years

Planned admission to our ward to undergo carotid endarterectomy

Materials and MethodsMaterials and Methods

OUR STUDY

OUR STUDY

Exclusion criteria:

• Restenosis

• Hostile neck

• Anatomical features :

• Kinking of internal carotid artery

• High carotid artery bifurcation

Materials and MethodsMaterials and Methods

OUR STUDY

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 Etheredge

Eversion endarterectomyAccording to DeBakey

Materials and MethodsMaterials and MethodsOUR OUR STUDY

STUDY

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 MethodsMaterials and Methods

OUR STUDY

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 MethodsMaterials and MethodsOUR STUDY

OUR STUDY

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 MethodsMaterials and Methods

OUR STUDY

OUR STUDY

Surgical Procedure

General Anesthesia

Stump Pressure Check

Cerebral/Somatic Oximeter (INVOS)

Quality control with duplex ultrasound intraoperatively after surgery

Materials and MethodsMaterials and Methods

OUR STUDY

OUR STUDY

Technically challenging?Shunting more difficult?

Worst end-point visualization?Longer operating and clamping time?

Lower re-stenosis rate?

Materials and MethodsMaterials and Methods

Preliminary ResultsPreliminary ResultsJanuary 2010- October 2013January 2010- October 2013

Patients Enlisted 254A total of 272 patients to enlist

254

135 119

Preliminar ResultsPreliminar ResultsJanuary 2010- October 2013January 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

Preliminary ResultsPreliminary ResultsJanuary 2010- October 2013January 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

Difference in shunt use for De Bakey eversion vs Etheredge eversion was not

statistically significant.

Preliminary ResultsPreliminary ResultsJanuary 2010- October 2013January 2010- October 2013

Morbi-mortality and major neurological complication

30 DAYS

DE BAKEY EVERSION GROUP 135 PZ1 Cerebral hyperperfusion syndrome (0,9%)

1 Stroke (0,9%)1 Respiratory distress syndrome (0,9%)

ETHEREDGE EVERSION GROUP 119 PZnone

Preliminary ResultsPreliminary ResultsJanuary 2010- October 2013January 2010- October 2013

Difference in morbi-mortality and major complications of DeBakey eversion vs

Etheredge was not statistically significant.

Preliminary ResultsPreliminary ResultsJanuary 2010- October 2013January 2010- October 2013

DB ET12 Months 4 (3,79%) 3 (2,66%) n.s

Re-stenosi > 70 %

12-month follow-up on 205 patient

3 patients re-treated 6 months

12 months

2 patients re-treated

12-month follow-up on 205 patient

Preliminary ResultsPreliminary ResultsJanuary 2010- October 2013January 2010- October 2013

Indication to treatment if re-stenosis > 80%

Overall number of patient re-treated at

12 months FU

5 pt

Preliminary ResultsPreliminary ResultsJanuary 2010- October 2013January 2010- October 2013

Results showed:

Technical feasibilityComparable morbi-mortality rate

Comparable restenosis rateComparable operating time

Not be the first to use the new, Not be the last to leave the old

Pope Alessandro VIII