Lifeline Registry of Endovascular Aneurysm Repair: Registry data report

SPECIAL REPORT

Lifeline Registry of Endovascular Aneurysm Repair: Registry data report Lifeline Registry o f E n d o v a s c u l a r A n e u r y s m Repair S t e e r i n g C o m m i t t e e Purpose: The goal of the Lifeline Endovascular Registry is to provide a minimal, yet comprehensive, data set of patient follow-up that can evaluate the long-term safety of endovascular grafts used in abdominal aortic aneurysm repair. Methods: Follow-up data have been collected on 1757 patients for this first report, including 1646 endovascular graft recipients and 111 surgical patients receiving treatment for abdominal aortic aneurysm. Results: Logistic regression of 1-year survival indicates that the factors most likely to decrease 1-year survival for the surgical group are renal failure and larger aneurysm size. For the endovascular graft recipients, the presence of renal failure, chronic obstructive pulmonary disease, congestive heart failure, larger aneurysm size, and increased age demonstrates a decrease in 1-year survival. Approximately 80% (1309) of the endovascular recipients have been followed for 1 year. Of these 1309 patients, 17% (222) have incurred an endoleak, and enlargement of the aneurysm has occurred in 4.6% (60). There was a total of 80 (4.9%) endovascular graft recipients converted to surgery. The most prevalent factors causing conversion to surgery were an increase in aneurysm diameter, aneurysm rupture, and the presence of a proximal endoleak. Conclusions: Although the data collected by the Registry thus far are limited, we anticipate rapid expansion of the Registry to include data from other manufacturers and investigators. Nevertheless, early data analysis does demonstrate the importance of surveillance of endovascular graft recipients. Through the collection and analysis of Registry data, adverse events continue to be captured, enabling the monitoring of long-term safety of endovascular grafts and the evaluation of graft performance. Data on comorbidities and postoperative factors, collected and evaluated for their effect on survival of the graft recipients, also provide information on optimal patient selection and management. We expect that the next report will support and expand on these findings, providing continuing evidence of the value of a national endovascular registry. (J Vase Surg 2002;35:616-20.)

The Lifeline Registry of Endovascular Aneurysm Repair has the goal of collecting long-term data on patients receiving endovascular grafts (EGs) and surgical patients. These data will be used to evaluate the aggregate safety and effectiveness of EGs in treating aneurysmal disease. This is the first data report from the Registry. The information presented herein represents data on two EG devices. PRELIMINARY RESULTS D e m o g r a p h i c data. Follow-up data have been collected on 1757 patients that were treated for an abdomi-

Competition of interest: The Lifi:linc Foundation has financial support from the following manufacturers, which are listcd in the article: CR Bard, Boston Scientific, Cook, Cordis, Edwards Litizsciences,Endologix, WL Gore & Associates, Gnidant, Medtronic AVE, and Sulzer Vascutek. Additional information about the Lifeline Registry can be tbund at http://www.lifelineregistry.org. Reprint requests: Sonja McKinlay, PhD, NERI, 9 Galen St, Watertown, MA 02472 (e-mail: [email protected]). Copyright © 2002 by Thc Society for Vascular Surgery and The American Association fbr Vascular Surgery. 0 7 4 1 - 5 2 1 4 / 2 0 0 2 / $ 3 5 . 0 0 + 0 24,/1/122232 doi: 10.1067/mva.2002.122232

616

nal aortic aneurysm. There are 1646 EG recipients registered from 40 clinical centers and 111 surgical patients from 18 centers (Fig 1, Table I). Whites comprise the overwhelming majority of the EG group (92.3%; 1519) and the surgical group (97.3%; 108). The majority of the patients receiving a graft (88.6%) or surgery (76.6%) were male (Table II). The mean age for graft recipients was 73.1 years, whereas the mean age fbr surgical patients was 71.1 years (Fig 2). The most prevalent risk factors in this patient population are hypertension, myocardial infarction, and chronic obstructive pulmonary disease (COPD). Both groups have similar baseline risk factors; however, EG recipients have significantly less hypertension than the surgical group (Table III). P r o c e d u r e data. The majority o f the aneurysms (85.7%) are between 40 and 70 mm, with nearly 50% in the range 50 to 59 mm. Both groups have a similar distrib u t i o n of aneurysm diameter. The significantly fewer patients with aneurysms in the 50 to 59 m m range in the surgical group may be a chance result in a multitesting environment. The m e a n aneurysm size for the surgical group is 55.1 mm, and for EG recipients, it is 55.7 m m (Table IV).

JOURNAL OF VASCULARSURGERY Volume 35, Number 3

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Fig 1. Patient distribution among sites. EG recipients make up the majority of patients in the Registry, even at sites with surgical patients.

T a b l e I. Patient distribution among sites

T a b l e II. Gender distribution*

Clinical centers EG (40 centers)

Mean Median

41.2 patients 25.5 patients

EG

SuEAical

Surgery (18 ct'.nters)

Ge**der

n

%

6.2 patients 5.5 patients

Female Male Total

187 1459 1646

11.4 88.6 100

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%

26 85 111

23.4 76.6 100

*Both groups are predominantly male. However, the surgical group includes significantlymore women than the EG group (P < .0001).

T a b l e I I I . Basclinc risk factors EG Risk factor

Myocardial infarction Hypertension Diabetes Renal insufficiency COPD CHF

n

613 1051 188 65 483 183

&~rgery %

n

%

37.2 63.9 l1.4 4.0 29.3 11.1

43 79 11 5 33 8

38.7 71.2 9.9 4.5 29.7 7.2

Three noticeable causes o f conversion to open surgery, aside from implant failure, are an increase in aneurysm diameter, rupture of the aneurysm, or a proximal endoleak from the endovascular graft (Table V), A d v e r s e e v e n t data. Adverse events were tracked at immediate postprocedure, discharge, 3 months postprocedure, 6 months postprocedure, and annually for 5 years. A total o f 1646 E G patients have participated in the Lifeline Registry. Table VI shows the number o f patients that have been seen tbr each data collection point. At most o f the

P value

.762 .004 .757 .8 .915 .268

visits, endolcaks were observed in at least 20% o f the graft recipients. The percentage o f deaths for graft recipients (14.9%) is similar to the percentage of deaths in the surgical group (12.6%). H o w e v e r , the cause o f death varies b e t w e e n groups. Deaths in the graft p o p u l a t i o n were primarily caused b y c a r d i o p u l m o n a r y arrest, myocardial infarction, cancer, and other, u n k n o w n causes. In contrast, deaths in the surgical group were primarily caused by pneumonia and cardiac arrest (Table VII).

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Fig 5. Effect of aneurysm size on survival for EG group. The probability of graft recipient survival is inversely proportional to aneurysm diameter. As aneurysm diameter increases, the probability that a graft recipient survives decreases.

T a b l e IV. A n e u r y s m diameter distribution at baseline EG Size

Unknown <40 mm 40-49mm 50-59mm 60-69mm 70-79 mm ~80 mm Total

Surgery

n

21 40 329 776 309 124 47 1646

%

n

%

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8 3 28 42 21 6 3 111

7.2 2.7 25.2 37.8 18.9 5.4 2.7 100

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T a b l e V. Surgical conversion cause a n d rate*

SURVIVAL ANALYSIS

Cause

Logistic regression o f 1-year survival indicates t h a t the factors m o s t likely to decrease 1-year survival for the surgical g r o u p are the p r e s e n c e o f renal failure a n d larger a n e u r y s m size. H o w e v e r , for the E G g r o u p , the factors are the presence o f renal failure, C O P D , congestive h e a r t failure ( C H F ) , larger a n e u r y s m size, a n d increased age. U s i n g Cox p r o p o r t i o n a l hazards models, the resulting survival curves are given in Figs 3, 4, a n d 5.

Aneurysm diameter increase Aneurysm rupture Proximal endoleak Distal endoleak Left iliac endoleak IM branch endoleak Lumbar branch endoleak Modular disconnection endoleak Endoleak source unknown Migration Loss of device integrity Implant failure Unknown

n

% of all conversions

8 11 9 1 1 1 2 1 6 5 2 44 4

10.0 13.8 11.3 1.3 1.3 1.3 2.5 1.3 7.5 6.3 2.5 55.0 5.0

*This table is not mutually exclusive. Patients with multiple causes for con version are listed more than once. Total number of patients converted is 80. IM, Infkrior mesenteric.

CONCLUSION Early data analysis d e m o n s t r a t e s t h e i m p o r t a n c e o f surveillance of EG recipients. Through the collection a n d analysis o f R e g i s t r y data, adverse e v e n t s w e r e capt u r e d , e n a b l i n g t h e m o n i t o r i n g o f l o n g - t e r m safety o f EGs and the evaluation of graft performance. Furt h e r m o r e , data o n c o m o r b i d i t i e s a n d p o s t o p e r a t i v e fact o r s w e r e c o l l e c t e d a n d e v a l u a t e d for t h e i r e f f e c t o n

620

JOURNAL OF VASCULAR SURGERY March 2002

Lifeline Registry

T a b l e V I . A d v e r s e events o f E G p a t i e n t s by t i m e p o i n t Event

Postprocedure n (%)

Discharge n (%)

Endoleak 407 (24.7) 4551 (28.4) Rupture 0 (0) 3 (0.2) Enlarged N/A 73 (4.6) aneurysnl Prosthesis 1 (0.1) 9 (0.6) migration Loss of device N/A 0 integrity Obstruction 55 (0.3) 13 (0.8) Change in 155 (1) 10 (0.6) graft alignment Total patients 1646 (100) 15589 (96.55) seen at this time

3 months n (%)

6 months n (%)

12 months n (%)

90 (20.4) 0 (0) 12 (2.7)

327 (23.3) 0 (0) 67 (4.8)

222 (17) 1 (0.1) 60 (4.6)

2 (0.4)

11 (0.8)

0 2 (0.4) 55 (1.i) 441 (6.8)

2 4 months n (%)

36 months n (%)

198 (21.4) 7 (0.8) 61 (6.6)

61 (14.7) 1 (0.2) 36 (8.7)

2 (0.2)

48(55.2)

30 (7.2)

3 (0.2)

3 (0.2)

8 (0.9)

7 (0.55) 1 (0.1)

9 (0.7) 6 (0.55)

1403 (855.2) 1309 (79.55)

48 months n (%)

60 months n (%)

16 (20.8) 0 (0) 7 (9)

1 (100) 0 (0) 0

7 (9)

1 (100)

7 (1.7)

0

0

4 (0.4) 55 (0.55)

1 (0.2) 3 (0.7)

3 (3.9) 0

0 0

926 (556.2)

4155 (255.2)

77 (46.8)

1 (0.1)

T a b l e V I I . P r i m a r y causes o f d e a t h EG Ca use

AAA rupture Cardiopulmonary arrest Cardiac arrest Myocardial infarction Respiratory failure Cardiac, other CHF COPD Pneumonia Pulmonary, other Cerebrovascular accident Renal failure Cancer Sepsis TAA rupture Other* Unknown Total

n

4 29 12 26 20 12 12 ,5 11 3 10 6 36 5 4 11 39 245t

Surgery %

1.6 1 1.8 4.9 10.6 8.2 4.9 4.9 2.0 4.5 1.2 4.1 2.4 14.7 2.0 1.6 4.5 15.9 100

n

1 0 2 1 1 0 1 0 3 0 0 0 3 0 0 2 0 14;t

%

7.1 5 0 14.3 7.I5 7.1 5 0 7.15 0 2 1.4 0 0 0 2 1.4 0 0 14.3 0 100

A A A , Abdominal aortic aneurysm; TAA, thoracic aortic aneurysm. *Other includes anoxic encephalopathy, mtraabdominal hemorrhage, hepatic fhilurc (2), amyotrophic lateral sclerosis complications, dementia, ischemic col-

litis, bowel obstruction, gastrointestinal bleeding (2), diabetes mcllitus. t14.9% of EG recipients. *12.6% of the surgical population.

survival o f t h e g r a f t r e c i p i e n t s . A l t h o u g h t h e s u r g i c a l d a t a c o l l e c t e d b y t h e R e g i s t r y t h u s far are l i m i t e d , a d d i t i o n a l d a t a f r o m o t h e r m a n u f a c t u r e r s will facilitate m o r e informative comparisons with the graft experience. We

expect that the next report, with considerably more d a t a , will s u p p o r t a n d e x p a n d t h e s e f i n d i n g s a n d p r o vide continuing evidence of the value of a national e n d o v a s c u l a r registry.