Long-Term Outcome of Open or Endovascular Repair of Abdominal Aortic Aneurysm

Jorg L. De Bruin, M.D., Annette F. Baas, M.D., Jaap Buth, M.D., Monique Prinssen, M.D., et al

The New England Journal of Medicine May 2010 vol 362

DREAM TRIAL

Presented by Ram Kumar Shrestha

AAA- a pathological focal dilatation of the aorta >30mm 1.5 times the adjacent diameter of the normal aorta 90 % of AAA is infrarenal, fusiform morphology Juxtarenal and suprarenal AAA F>M
Etiology Atherosclerosis But clinically significant peripheral occlusive disease is unusual and present in <10 %

Clinical presentationSymptomatic Back pain/abdominal pain +- pulsatile abdominal mass Asymptomatic Natural history of AAA Expand -------> Rupture staccato pattern of growth Average aggregate growth 3-4mm/year Large aneurysm expand faster Rupture Risk directly related to aneurysm size Rupture risk low for <5.5cm, then rise exponentially F>M A rapid expansion >0.5cm/6 months
Fleming C et al: Ann Intern Med 142:203,2005 Lederle FA et al: Arch Intern Med 160:1117, 2000

Indication for Repair Ruptured AAA mortality rate- 71-77% Elective Surgical Repair MR 2-6 Symptomatic AAA 80% 1 year Mortality rate without repair 80% 1 year survival rate with repair Asymtomatic AAA Size AP diameter >55mm Rupture risk <1% for size <5.5cm >20% for size ~7.0 cm

Management Option
1. Regular USG assessment of aneurysm size for asymtomatic <5.5cm 2. Open Surgical Procedure 3. Endoluminal Procedure

Advantage of Open Surgical Repair AAA permanently eliminated Risk of aneurysm recurrance/delayed rupture -nil Direct assessment of Colon integrity

Disadvantage/Complications Cardiac arrhythmias, MI GI Complications- , Ischaemic Colitis, aortoenteric fistula Renal Failure Prosthesis infection

Advantage of Endoluminal Procedure Minimally invasive procedure Superior in pts unfit for surgery due to age/comorbidities Short convalescence period

Disadvantage/complications Anatomic Eligibility required Endoleaks/rupture Migration cost

Endovascular Repair is superior to Open repair in perioperative survival benefit.

Long term data lacking Concerns regarding durability of this procedure Delayed risk of rupture Reinterventions

AIMTo provide long term data on compare EVAR and Open Repair

Methodology:

A multicentered 26 centre in Netherland+ 4 in Belgium

Long term median duration 6.4 years

Randomized controlled trial Computer generated Permuated block sequence Stratification in blocks of 4 patients

Study Patients
Patients with AAA >= 5 cm

Suitable for both Open and Endovascular Repair

Suitability determined by cardiologist or internist for open repair and for endovascular repair determined by means of endograft dependent anatomical criteria

Ideal Characteristics of an Aneurysm for Endovascular Abdominal Aortic Aneurysm Repair

Neck length (mm) Neck diameter (mm) Aortic neck angle () Neck mural calcification (% circumference) Neck luminal thrombus (% circumference) Common iliac artery diameter (mm) 20 Common iliac artery length (mm) External iliac artery diameter (mm) >15 >18, <32 <60 <50

<50 between 8
>20 >7

EXCLUSION CRITERIA

-emergency aneurysm repair -inflammatory aneurysm -anatomical variation eg horse shoe kidney -connective tissue disease -hx of organ transplantation -life expectancy of less than 2 yrs

DATA COLLECTION AND FOLLOW UP

F/U Schedule: 30 days, 6,12,18 and 24 months Questionnaire about physical and mental health Every 6 months thereafter

EVAR Group- annual f/u with CT Yearly Open Group- advised to see physician
At 5 year: Both group f/u with CT Scan

PRIMARY OUTCOME A. Rate of Death from any cause Inhospital Death: any death occurring within 30 days After the original procedure or any death occurring more than 30 days after procedure but during same hospital stay Cardiovascular cause: MI, CHF, Cardiac arrest, Stroke, ruptured aneurysm Noncardiovascular: cancer, Pulmonary conditions, miscellaneous disorder

B. Reintervention: Any surgical or reintervention procedure that was related to the primary aneurysm repair procedure. Indication for reintervention: 1. Graft related indications: thrombo-occlusive disease,
Endoleak type 1 or endotension, endograft migration, prosthesis infection, graft material failure, paraanastomotic aneurysm and aneurysm rupture

2. Wound related indications: incisional hernia and wound

infection

3.Local or sytemic indications: bleeding, endoleak type 2, Ileus

RESULT

Enrollment and Outcome

Baseline Characteristics
Characteristics Open repair n= 178

Age- yr
Male sex-no(%) Pts with SVC/ISCVS risk factor score-% DM Tobacco use Hypertension Hyperlipidemia

69.6+-6.8
161(90.4) 9.6 55.1 54.5 52.6

Endovascular repair P value n = 173 70.7+-6.6 0.13 161(93.1) 10.4 64.2 58.4 47 0.44 .86 .10 .52 .33

Carotid Disease
Cardiac disease Renal Disease Pulmonary disease Sum of SVS/ISVC Risk Factor scores FEV1 L/sec BMI ASA class- no(%) I Healthy II Mild Systemic Disease IIISevere Systemic disease

15.2
46.6 8.4 18.5 4.5+-2.5 2.6+-0.7 26.6+-4.1 44(24.7) 110(61.8) 24(13.5)

14.5
41.0 7.5 27.7 4.4+-2.5 2.5+-0.7 26.3+-3.4 37(21.4) 122(70.5) 14(8.1)

.88
.33 .85 .04 .61 .27 .47 .53 .09 .12

Medications use no(%) Beta Blocker Statin Antiplatelet agent ACEi CCB 92(51.7) 72(41.9) 72(40.4) 50(28.1) 32(18) 76(43.9) 63(37.3) 70(40.5) 58(33.5) 30(17.3) .17 .44 1.00 .30 .89

Anticoagulant

27(15.2)

20(11.6)

.35

Overall Survival
Cumulative survival rate after 6 years Open repair 69.9% Endovascular -68.9% p=0.97

Kaplan-Meier estimate Of survival

Cause of Death

Open repair overall 60 Inhospital death 8, after discharge 51, 1 prior to surgery 20 cardiovascular cause 40 non cardiovascular Endovascular repairOverall 58 Inhospital death 2 after discharge 55, 1 prior to surgery 16 cardiovascular cause 42 non cardiovascular)

Reintervention Cumulative rate of freedom from reintervention Open repair 81.9% Endovascular repair 70.4% P=0.03

Reintervention Open Group: Correction of incisional hernia EVAR Group: Endograft related complications such as Endoleak and Endograft Migration

Discussion Inhospital Death is less in Endovascular group in this study and consistent with the findings of other studies.
study DREAM TRIAL EVAR-1 TRIAL Open % 4.6 4.7 Endovascular % 1.2 1.7

OVER TRIAL
ACE Trial

3.0

0.5

The pulmonary comlications has been implicated as the cause of death in Open group

Short term Survival benefit counterbalanced by mid term Rise in mortality in Endovascular group. However the rise in mortality observed were because of Miscellaneous cause rather than endograft related. The Midterm rise in mortality in endovascular group were Not found in OVER Trial. Endovascular Repair is Durable, and there is no Disadvantage in overall long term survival.

Stastically significant high reintervention rate in Endovascular repair is Due to Graft related indications Thromboocclusive disease Endoleak But the most of the reintervention were occurred after 4 yrs after the procedure. OVER TRIAL and EVAR 1 Trial reported less intervention In Endovascular group- Short term data reported, no 4 year Data included. Incisional hernia is the most common wound related Indication for reintervention in Open repair.

Conclusion: Endovascular and Open Repair of AAA Similar Rate of long term survival

Rate of secondary intervention is higher in endovascular repair in long run.

Both types of repair complement each other in AAA Management. The Comorbid conditions and anatomic Criterion needed to be considered before selecting the Repair method

Limitation
1. Outcome based on size not studied. 2. Device specific Outcome- reintervention rate 3. QOL other than reintervention ?? 4. Biasness on follow up Less Ct reporting in Open group Might have affected finding of more graft related problem in Endovascular group

Thank You