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Clinical Effectiveness in the Treatment of Abdominal Aortic Aneurysms Julie Ann Freischlag, M.D. Department Director, Surgery Johns Hopkins Medical Institution.

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Presentation on theme: "Clinical Effectiveness in the Treatment of Abdominal Aortic Aneurysms Julie Ann Freischlag, M.D. Department Director, Surgery Johns Hopkins Medical Institution."— Presentation transcript:

1 Clinical Effectiveness in the Treatment of Abdominal Aortic Aneurysms Julie Ann Freischlag, M.D. Department Director, Surgery Johns Hopkins Medical Institution Surgeon-in-Chief Johns Hopkins Hospital 1

2 2

3 There is no standard definition for comparative effectiveness. 3

4 IOM Definition “the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care.” 4

5 Patient Protection and Affordable Act 2010 Terminated Federal Coordinating Council for CER Established non-profit PCORI To identify research priorities Overseen by Board of Governors, assisted by Advisory panels CER findings may not be construed as mandates, guides or recommendations for payment, coverage or treatments 5

6 EFFECTIVENESS Represents outcomes from a treatment or health intervention in real practical settings (e.g., the real world) 6

7 EFFICACY Represents outcomes achieved from treatment or health intervention under ideal circumstances (clinical trials) 7

8 Abdominal Aortic Aneurysms 13th leading cause of death in US10th leading cause of death in menTotal - 15,000 deaths/year 8

9 Abdominal Aortic Aneurysms cigarette smoking (8:1)hypertension (40% with AAA) genetic predisposition (30% have a first order relative with an aneurysm) hemodynamic factors 9 Risk Factors

10 Abdominal Aortic Aneurysms 4.0 - 5.4 cm 0.5 - 1.0% 6.0 - 7.0 cm 6.6% > 7.0 cm 19% Risk of Rupture (yearly) 10 Bernstein, AnnSurg 200:255, 1984

11 EFFECTIVENESSEFFECTIVENESS 11

12 Impact of hospital teaching status on survival from ruptured abdominal aortic aneurysm repair Robert A Meguid MDMPH, Benjamin S. Brooke, MD Bruce A. Perler MDMBA, and Julie A. Freischlag MD, Baltimore, Maryland JVS: 2009;50:243-50 12

13 Methods Utilized the Nationwide Inpatient Sample (NIS) file between 1998 – 2004 Diagnosis of ruptured abdominal aortic aneurysm Outcomes were discharge or in–hospital death and patient variables (age, gender, race and comorbidities) Hospital level independent variables (teaching hospital, volume of open AAA and EVAR for rAAA) 13

14 Results 11,470 patients diagnosed with rAAA on discharge summary 4,441 (38.7%) did not undergo surgical repair 6,636 underwent open AAA for rAAA 369 underwent EVAR for rAAA 5,500 males (78.5%); average age 74 14

15 Results Of 6,636 open repairs, perioperative mortality was 42% Mortality was lower at teaching hospitals (39.3% vs 44.5%; p<.05) (General Surgery training hospital – 38.7%; Vascular Surgery training hospital – 34.3%) 25% decrease in-hospital death at Vascular Surgery training hospital 15

16 Results Of the 369 EVAR repairs, perioperative mortality was 33.3% Mortality at teaching hospital was 26% vs 47.2% at non-TH (p<.001) 25.2% at GSTH and 38.7% non-GSTH (p=.01) 19.8% at VSTH and 39.0% at non-VSTH (p<.001) 16

17 Conclusions In addition to factors associated with teaching hospitals in general, the type of specialty training within teaching institutions is a critical factor. 17

18 Ruptured Rate of Large Abdominal Aortic Aneurysms in Patients Refusing or Unfit for Elective Repair Lederle, Johnson, Wilson, Ballard, Jordan, Blebea, Litooy, Freischlag, Bandyk, Rapp, Salam, Veteran’s Affairs Cooperative Study #417 Investigators JAMA 2002: 287:2968 - 2972 18

19 Objective: To determine the incidence of rupture in patients with large AAA in a prospective cohort study in 47 Veterans Affairs Medical Centers 19

20 Patients: Veterans (n=198) with AAA at least 5.5cm for whom elective AAA repair was not planned because of medical contraindication or patient refusal Patients were enrolled between April 1995 and April 2000 and followed up through July 2000 (mean 1.52 years) 20

21 Results: Outcomes ascertainment was complete for all patientsThere were 112 deaths (57%) and autopsy rate was 46%45 patients had probable AAA rupture 21

22 Results: 1 –year incidence of probable rupture by initial AAA diameter: 5.5 - 5.9cm 9.4% 6.0 - 6.9cm10.2% 6.5 - 6.9cm 19.1% 7.0cm or greater32.5% The likelihood of the AAA reaching 8.0cm during follow- up resulted in at 25.7% rupture rate in 6 months 22

23 Conclusions: The rupture rate is substantial in high–operative risk patients with AAA of at least 5.5cm in diameter and increases with larger diameter. 23

24 Rural Hospitals Face a Higher Burden of Ruptured AAA and are more likely to Transfer Patients for Emergent Repair Rubie Sue Maybury, MD, MPH 1 David C. Chang, PhD, MPH, MBA 2 Julie A. Freischlag, MD, FACS 3 1 Department of Surgery, Georgetown University Hospital 2 Department of Surgery, University of California San Diego 3 Department of Surgery, The Johns Hopkins Medical Institution

25 Objective To assess how rural hospital location influences: ● ruptured AAA presentation ● transfer after ruptured AAA AAA Elective presentation Ruptured presentation Admitted Transferred Dead Alive ● death after ruptured AAA

26 67,376 patients with elective AAA repair or rAAA Age < 50 years: 532 Traumatic aortic aneurysm: 6 Thoracic aneurysm: 22 Thoracoabdominal aneurysm: 105 Aortic aneurysm, site NOS: 8 Transferred in : 754 Rural/urban status unknown: 18,916 47,033 patients analyzed for ruptured presentation Elective AAA repairs: 40,203 6,830 patients with rAAA analyzed for transfer Transferred to an outside hospital: 148 6,682 patients with rAAA analyzed for death Results Subject Inclusion/Exclusion

27 Rural (n=2,624)Urban (n=44,409)p-value Age, mean (years)73.873.3 0.005 Male sex, %74.978.5<0.001 Race, % White Black Hispanic Other 97.1 1.8 0.5 0.6 92.1 3.4 2.7 1.9 <0.001 Insurance Status, % Medicare Private Medicaid Uninsured/other 81.7 13.7 1.0 3.6 77.7 18.9 1.4 2.0 <0.001 Charlson’s index, median 2.1 2.0 0.002 Results Unadjusted Analysis

28 Rural (n=2,642)Urban (n=45,145)p-value Teaching hospital, %30.3%55.7%<0.001 Annual elective AAA repair volume 0 1-14 ≥15 11.1% 47.2% 41.7% 0.7% 17.2% 82.2% <0.001 GPs per 100,000 population 83.084.9 0.021 Vascular surgeons per 100,000 population 2.9 1.1<0.001 Results Unadjusted Analysis

29 Ruptured Presentation 1, OR (95% CI) Transfer 1, OR (95% CI) In-hospital death 1,2, OR (95% CI) Rural location 2.47 (1.90 – 3.19)* 1.80 (1.14 – 2.85)*0.96 (0.73 – 1.27) Teaching hospital 0.79 (0.68 – 0.92)*0.65 (0.37 – 1.15) 0.94 (0.81 – 1.09) Hospital annual elective AAA repair volume 0 1-14 ≥15 N/A 16.1 (9.0 – 28.9)* 2.26 (1.27 – 4.01)* Ref 1.70 (1.23 – 2.32)* 1.28 (1.11 – 1.48)* Ref GPs per capita, increase by 10/100,00 0.97 (0.94 – 1.00)*N/A Vascular surgeons per capita, increase by 10/100,000 0.59 (0.39 – 0.90)* 0.67 (0.08 – 5.91)0.64 (0.44 – 0.92)* 1 adjusted for age, sex, race, insurance, Charlson’s index, calendar year, 2 adjusted for repair type Results Adjusted Analysis

30 Rural hospitals face a disproportionate burden of rAAA. Rural hospitals are more likely than urban hospitals to transfer patients with rAAA, leading to delay in repair. For patients who are not transferred, mortality is similar at rural and urban hospitals. Conclusions

31 EFFICACY 31

32 Immediate Repair Compared with Surveillance of Small Abdominal Aortic Aneurysms Aneurysm Detection and Management Veterans Affairs Cooperative Study Group NEJM 2002:346:1437 - 44 32

33 Purpose: 33 To determine if elective surgical repair of small abdominal aortic aneurysms improves survival

34 Results 569 patients immediate open repair 567 surveillance 34 By the end of the study, 92.6% of open repair had undergone operation and 61.6% were in the surveillance group

35 Results: Primary end point was death from any cause and was not significantly different in the 2 groups. (1.21, 95% confidence intervals, 0.95 – 1.54) No reduction in rate of death related to abdominal aortic aneurysm in the immediate – repair groups (3.0%) as compared with the surveillance group (2.6%) Mortality rate in immediate open repair was 2.7% 35

36 Results: 11 of the surveillance group ruptured (0.6%) resulting in 7 deaths Rate of hospitalization related to AAA was 39% lower in the surveillance group 36

37 Conclusion: 37 Survival is not improved by elective repair of AAA smaller than 5.5cm, even when operative mortality is low.

38 Two-Year Comparison of Endovascular and Open Repair of Abdominal Aortic Aneurysm Frank A. Lederle, MD Julie A. Freischlag, MD Tassos C. Kyriakides, PhD Frank T. Padberg Jr, MD Jon S. Matsumura, MD Ted R. Kohler, MD Peter H. Lin, MD Jessie M. Jean-Claude, MD Dolores F. Cikrit, MD Kathleen M. Swanson, MS RPh Peter N. Peduzzi, Ph D for the Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group

39 Design 39 Multicenter randomized trial AAA ≥ 5.0 cm, candidate for both procedures Open repair vs. any FDA- approved EVR system 1º outcome = mortality

40 OVER Patient Characteristics 99.3% male 87% white Mean age: 70 years Mean wt: 90 kg Current smoker: 41% Coronary artery disease: 41% AAA diameter < 5.5 cm: 43% ≥ 6.0 cm: 27% 40 EVR system: Cook Zenith: 39%, Gore Excluder: 37% Medtronic Aneurx: 21%, Guidant/Endologix: 3%

41 Outcome EVROpen n = 444n = 437 No.(%) Total deaths 31 (7.0)41 (9.4) Cause of death AAA-related6 (1.4)13 (3.0) Within 30 days after repair1 (0.2)10 (2.3)P = 0.006 Within 30 days or inpatient2 (0.5)13 (3.0)P = 0.004 AAA < 5.5 cm1 (0.5)5 (2.6) AAA > 5.5 cm1 (0.4)8 (3.2)P = 0.02 Cardiovascular9 (2.0)4 (0.9) Cancer10 (2.3)13 (3.0) Other5 (1.1)7 (1.6) Unknown1 (0.2)4 (0.9) 41

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43 Other outcomes: EVR group: 134 endoleaks in 110 pts (25%) → 20 secondary therapeutic procedures in 17 pts Open group: 31 incisional hernias (7.1%) → 25 secondary therapeutic procedures in 22 pts 43 No ruptures identified at 2 years

44 44

45 Conclusions: No significant difference in the primary outcome of total mortality in this two-year analysis Post-op mortality was lower for EVR than open, and lower for both procedures than in earlier trials. Secondary procedures, AAA-related hospitalizations, & claudication were more frequent after EVR, but NS No difference in major morbidities, QOL, ED No increased late mortality after EVR by two years Longer term data are needed to fully assess the relative merits of the two procedures 45

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