Endovascular versus Open Repair of Abdominal Aortic. Ashish Jai Kishan

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Endovascular versus Open Repair of Abdominal Aortic Aneurysm: 

Endovascular versus Open Repair of Abdominal Aortic Aneurysm May 20 th 2010

Background : 

Background AAA- prev. esp older men. As size of AA , so risk of rupture. T’fore, prophylactic repair with insertion of prosthetic graft. 1951-open surgical repair. 1986-Mini. invasive EV A repair

Slide 3: 

3 RCT comparing EV & O repair AAA -shown marked benefit of EV-with respect to 30-day operative mortality. T’fore, EV repair has become a common t/t option.

Slide 4: 

EUROSTAR Registry- ( European Collaborators on Stent/Graft Techniques for AA Repair) , provides data for mean follow-up of only 3 yrs on pats who received 1 st generation endografts, which had relatively poor performance as compared with endografts that are currently in use.

Slide 5: 

Good-quality data regarding longer-term durability, $ & effects of EV repair are limited. In current trial, ie EVAR 1 trial, authors ‘ve compared long-term results of EV vs O of large A.

Slide 6: 

EVAR Trial 1 : A multi-centred RCT comparing EVAR & O repair in pats considered fit for O repair. EVAR Trial 2 : A multi-centred RCT comparing EVAR with medical t/t against medical t/t alone for pats considered unfit for O repair.

Methods : 

Methods

Slide 8: 

1999-2004- 37 hospitals UK, 1252 pats with large A(≥5.5 cm) randomly assigned:- either EV/O 626 pats assigned- each gp. Pats followed-rates of death, graft-related cxs, reinterventions,till end of ‘09

Slide 9: 

Pats who weren’t considered candidates for O repair but for EV repair were offered enrollment in Endovascular Aneurysm Repair 2 (EVAR 2) trial. Pats encouraged to undergo repair within 1 mth after randomization.

Slide 10: 

CT-at 1 & 3 mths in pats undergoing EV repair & annually in all pats in 2 study gps. 1 ry outcome -death from any cause, included A-related death, graft-related cxs & graft-related reinterventions.

RESULTS: 

RESULTS

Slide 12: 

1 st Sep ’99 to 31 st Aug ’04- 1252 pats in EVAR 1- equally & randomly divided into 2 gps. No signi. Diff. b/w 2 t/t gps with respect to baseline characteristics

Slide 15: 

Pats followed till 1 st Sep ‘09 (min 5 yrs; max 10 yrs). Median follow-up until death/end of study 6 yrs & 1% lost to follow-up in terms of mortality. During study,1216 A-repair performed, including 8 emergency

Slide 16: 

Pats undergoing A repair, median time from randomization to surgery- 44 days in EV repair & 35 days O-repair gp .

OPERTATIVE MORTALITY : 

OPERTATIVE MORTALITY

Slide 18: 

30 Days after surgery, death In Ev Gp 11/614 patients (1.8%) (including 1 pat- emergency repair) In O Gp 26/602 patients (4.3%) (including 1 pat-emergency repair)

Slide 19: 

In EVAR 2, 30 day operative mortality was 13/150, 9% significantly > than 1.7% 30 day mortality for EVAR in EVAR 1 trial (p<0.0001).

Slide 20: 

Of 12 pats in EV-repair gp who didn’t undergo A-repair: 7 died within 6 mth after randomization (3 as result of rupture), 3 physically ineligible, 1 declined surgery, & 1 anatomically unsuitable

Slide 21: 

Of the 24 patients in O-repair gp: 7 died within 6 mth (3 as result of rupture), 7 physically ineligible, 8 declined surgery (of whom 3 died), & 2 had an unknown reason

Graft-Related Cxs & Reinterventions: 

Graft-Related Cxs & Reinterventions

Graft-Related Cxs & Reinterventions: 

Overall rates of graft-related Cxs & reinterventions were > by a factor of 3 to 4 in EV -repair group than open-repair group Graft-Related Cxs & Reinterventions

COST : 

COST

Slide 31: 

Mean cost of primary A-repair. EV gp $19,698 , O gp $17,917 M. cost of A-related readmissions EV gp $3,454 , O gp $669 8 yrs follow-up, total avg. cost of A-related procedures EV gp $4,568 > O-repair group

Slide 32: 

1 ry admission & later admissions for graft related reinterventions contributed almost equally to cost difference.

Discussion : 

Discussion

Slide 34: 

Results over median follow-up period of 6 yrs confirmed previously published midterm findings that operative mortality a/ w EV-repair of AAA was only a third of that a/w O-repair & A-related mortality was < during early yrs after EV repair

Slide 35: 

H/e, early benefit -completely lost in longer term,with >A-related mortality after 4 yrs in EV gp than O gp. No signi diff. in total mortality b/w the 2 study gps. Rate of graft-related cxs after EV repair remained substantial after 4 yrs, as did need for reinterventions.

Slide 36: 

2 ndry rupture after A repair- reported only after EV repair & appeared to explain long-term >in A-related mortality. In contrast, O repair was very durable but was a/w > operative mortality.

Slide 37: 

These findings ‘ve implications for selection of patients for EV repair, choices for patients, surveillance after repair, & cost-effectiveness. Results also confirm -careful long-term followup of surgical innovations is essential.

Slide 38: 

After postoperative period , Half of all deaths were attributed to CV ds (including A). Cancer-Just over one quarter A-related- 20 pats in EV gp & 6 O gp

Slide 39: 

2 of late deaths in O gp were from graft ruptures in patients who had been assigned to O repair but had undergone EV repair. In total, 25 2 ndry A ruptures were reported, & of those 18 (72.0%) were fatal.

Slide 40: 

Therefore, loss of A-related survival benefit in the EV-repair group would appear to be attributable principally to endograft rupture. Many of patients in whom such an event occurred had graft-related cxs that were detected before rupture.

Limitations: 

Limitations

Slide 42: 

1st , although trial used 2 nd & 3 rd generation endografts, subsequent iterations of grafts would now be more com. choices of device. Long-term durability of these later iterations hasn’t been evaluated, but is hoped they would be a/w < cxs rates.

Slide 43: 

2 nd ,trial started 3 yrs before standardized reporting of graft-related Cxs. Thus, reporting of cxs reflected assessments made by radiologists in participating centers, & these reports were not evaluated in core laboratory.

Slide 44: 

3 rd , authors didn’t record outpatient procedures, which would ‘ve included minor procedures, eg diagnostic angiography, that are often performed after EV repair to obtain more detailed information on any potential cxs.

Conclusion : 

Conclusion

Slide 46: 

Pat who underwent either EV/ O Repair , EV was a/w a significantly < operative mortality. H/e, no signi diff seen in total mortality/ A-related mortality in long term. EV repair was a/w > rates of cxs & reinterventions & was more costly.

Slide 47: 

Current interpretation for EVAR 1 EVAR had an ongoing 3% better A-related survival than O repair but no demonstrable all-cause mortality/ HRQL benefit. Need for interventions mandates ongoing surveillance & longer follow-up for detailed cost-effectiveness evaluation.

Slide 48: 

Current interpretation for EVAR 2 Considerable 30 D operative mortality in pats already unfit for O repair of their A. EVAR didn’t improve longer-term survival & a/w need for continued surveillance & re-interventions, at substantially > cost.

Slide 49: 

Current interpretation for EVAR 2 Thus, in these sick pats emphasis has shifted towards improving pat fitness before considering EVAR, particularly in terms of cardiac, resp & renal fxn. Ongoing follow-up of these patients is an important priority.

Slide 50: 

Thank you