Massachusetts General Hospital

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Presentation transcript:

Massachusetts General Hospital Effect of Nonadherence to Instructions For Use on Outcomes of Endovascular Treatment of Ruptured Abdominal Aortic Aneurysms Linda J. Wang, MD, MBA Massachusetts General Hospital Good afternoon and thank you for the opportunity to present our work

Disclosures None We have no disclosures

Ruptured AAA (rAAA) For the treatment of ruptured abdominal aortic aneurysms, endovascular repair has become the preferred modality.

EVAR Anatomic Constraints However, anatomic constraints, can limit EVAR utilization and compromise performance.

IFU Nonadherence IFU non-adherence rates: 38% to 69% High rates of IFU nonadherence have been reported in elective AAA repair, ranging from 38 to 69% IFU non-adherence rates: 38% to 69%

Objectives Assess rates of IFU nonadherence in rAAA patients treated with EVAR Assess effect of IFU nonadherence on rAAA outcomes However EVAR IFU nonadherence has not been studied in ruptured populations. Furthermore, the effect of IFU nonadherence on outcomes has yet to be assessed. To that end this study sought to assess…

Methods Review of all rAAA repairs in the VQI, 2003-2018 Neck-specific IFU violations assessed: Diameter >28mm Length <15mm Angulation >60 Cohorts: All open and endovascular repairs in the Vascular Quality Initiative from 2003-2018 were reviewed. Neck-specific IFU violations were assessed and included diameter >28mm, length <15mm, and angulation >60. rEVAR IFU compliant (cIFU) IFU non-compliant (nIFU)

Methods Review of all rAAA repairs in the VQI, 2003-2018 Neck-specific IFU violations assessed: Diameter >28mm Length <15mm Angulation >60 Cohorts: Among ruptured patients treated with EVAR, those with at least one IFU violation were compared to IFU compliant patients rEVAR IFU compliant (cIFU) IFU non-compliant (nIFU) VS

Methods Review of all rAAA repairs in the VQI, 2003-2018 Neck-specific IFU violations assessed: Diameter >28mm Length <15mm Angulation >60 Cohorts: Propensity-matched This non-IFU compliant EVAR cohort was also compared to a propensity matched cohort of ruptured patients who underwent open repair rOSR rEVAR p-rOSR vs IFU compliant (cIFU) IFU non-compliant (nIFU) p-nIFU VS

Methods Primary outcomes: Perioperative complications: CV, pulmonary, renal, bowel/limb ischemia, reoperation 30-day mortality 1-year mortality Univariate analysis, Cox regression, Kaplan-Meier analysis Primary outcomes included perioperative major complications and 30-day and 1-year mortality. Univariate analysis, Cox regression, and Kaplan-Meier analysis were performed.

rEVAR: cIFU vs nIFU cIFU n=595 nIFU n=317 p Demographics Age, years Demographics cIFU n=595 nIFU n=317 p Age, years 73  10 .47 Sex, female 105 (18%) 73 (23%) .051 Caucasian race 520 (87%) 282 (89%) .49 Comorbidities Hypertension 448 (75%) 241 (77%) .66 CHF 83 (14%) 40 (13%) .60 Smoking history 452 (77%) 245 (77%) .78 COPD 156 (26%) 82 (26%) .97 Diabetes 107 (18%) 50 (16%) .40 Max AAA dia, mm* 70 (58,85) 76 (61,90) .002 Among EVAR patients, the compliant and noncompliant cohorts were similar with respect to demographics * median (IQR)

rEVAR: cIFU vs nIFU cIFU n=595 nIFU n=317 p Demographics Age, years Demographics cIFU n=595 nIFU n=317 p Age, years 73  10 .47 Sex, female 105 (18%) 73 (23%) .051 Caucasian race 520 (87%) 282 (89%) .49 Comorbidities Hypertension 448 (75%) 241 (77%) .66 CHF 83 (14%) 40 (13%) .60 Smoking history 452 (77%) 245 (77%) .78 COPD 156 (26%) 82 (26%) .97 Diabetes 107 (18%) 50 (16%) .40 Max AAA dia, mm* 70 (58,85) 76 (61,90) .002 Except nIFU tended to have larger maximal aortic diameters * median (IQR)

rEVAR: cIFU vs nIFU cIFU n=595 nIFU n=317 p Perioperative Outcomes MI Perioperative Outcomes cIFU n=595 nIFU n=317 p MI 34 (6%) 30 (10%) .03 Respiratory complication 74 (13%) 69 (22%) <.001 Stroke 13 (2%) 9 (3%) .54 Death 45 (14%) 42 (22%) .01 Major complication, any 158 (27%) 107 (34%)

rEVAR: 1-Year Survival p=.06

P-matched: nIFU EVAR vs OSR Demographics nIFU n=172 OSR p Age, years 74  9 1 Sex, female 40 (23%) 38 (22%) .80 Caucasian race 156 (91%) 165 (96%) .052 Comorbidities Hypertension 134 (78%) 130 (77%) .75 CHF 15 (9%) .96 Smoking history 136 (79%) COPD 42 (4%) 42 (24%) Diabetes 25 (15%) 27 (16%) .76 Max AAA dia, mm 74  22 75  20 .87 The propensity matched open and noncompliant EVAR cohorts were similar with respect to demographics

P-matched: nIFU EVAR vs OSR Perioperative Outcomes nIFU n=172 OSR p MI 16 (9%) 29 (18%) .02 Respiratory complication 35 (21%) 70 (44%) <.001 Stroke 4 (2%) 2 (4%) .54 Death 37 (22%) 55 (32%) .03 Major complication, any 57 (33%) 110 (68%)

P-matched: 1-Year Survival

Predictors 30-day Mortality

Conclusion >1/3 rAAA EVAR patients fall outside of IFU guidelines Among EVAR, non-compliant IFU patients have worse outcomes than compliant IFU patients After matching, non-compliant IFU EVAR patients have better perioperative morbidity than patients undergoing open repair This analysis demonstrated that over one-third of ruptured AAA patients who undergo EVAR fall outside of IFU guidelines. This nonadherent IFU cohort has worse outcomes when compared to IFU-compliant rEVAR patients. However, when comparing these patients to those undergoing open repair, nonadherent IFU rEVAR patients have lower perioperative morbidity and mortality. This study suggests that IFU nonadherence rates are high in patients undergoing rEVAR, but neck-specific IFU violations are not necessarily an absolute contraindication for stent graft repair. Endovascular treatment in patients with less favorable anatomy has significantly lower morbidity compared to open repair.

Thank you Questions?