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Endovascular stenting of abdominal aortic aneurysm in patients unfit for elective open surgery
RESEARCH LETTERS 5
Schanen C, Francke U. A severely affected male born into a Rett syndrome kindred supports X-linked inheritance and allows extension of the exclusion map. Am J Hum Genet 1998; 63: 267–69.
University Department of Medical Genetics and Regional Genetic Service, St Mary’s Hospital, Manchester M13 0JH, UK (J Clayton-Smith FRCP, P Watson BSc, S Ramsden PhD, G C M Black FRCOphth) and University Department of Ophthalmology, Manchester Royal Eye Hospital, Manchester (G C M Black FRCOphth) Correspondence to: Dr Jill Clayton-Smith
Endovascular stenting of abdominal aortic aneurysm in patients unfit for elective open surgery R J F Laheij, C J van Marrewijk, on behalf of the Eurostar group Endovascular aneurysm repair is useful for patients who are judged unfit for surgery. We investigated the outcome of endovascular repair of abdominal aortic aneurysm in patients fit and unfit for surgery. The 1-year cumulative survival for patients unfit for surgery and patients unfit for general anaesthesia was 20% and 23%, respectively. The overall health status of patients was an important predictor of survival after endovascular repair. The risks of endovascular aneurysm repair might, therefore, exceed that of non-operative management. Caution should be used when advising these patients about endovascular repair.
Endovascular stenting of abdominal aortic aneurysms, introduced at the beginning of the 1990s, is thought to be especially useful for patients unfit for elective surgery.1 In highrisk patients, however, just as in other types of patients, the decision to treat must be based on knowledge of the potential risks and benefits. We aimed to investigate and compare the outcome of endovascular repair of abdominal aortic aneurysms in patients in good medical condition with those who were judged unfit for open surgery or general anaesthesia. We obtained data on characteristics of patients, vascular risk factors, operative technical details, and outcome from the EUROpean collaborators registry on Stent-graft Techniques for abdominal aortic Aneurysm Repair (EUROSTAR).2 All patients received information about the registry and consented to have their data included in the study. Standard case-record forms were sent by the EUROSTAR organisation to participating institutions, who completed and returned them after the discharge of each patient and after each outpatient visit. Information from clinical examinations and imaging studies was obtained before and during the procedure, before discharge, at months 1, 3, 6, 12, 18, and 24, and yearly thereafter. The overall general medical condition of patients, as determined by the surgeon or anaesthetist at the different centres, was characterised on case-report forms as unfit for open surgery or unfit for anaesthesia. We recorded details of all
deaths and assessed mortality during follow-up by KaplanMeier survival analysis. Between 1994 and April 2000, 2442 patients with abdominal aortic aneurysms underwent endovascular repair in 80 institutions; 245 (10%) patients were unfit for open surgery and 97 (4%) were unfit for general anaesthesia. The main reasons for denying elective abdominal aortic aneurysm repair were: cardiovascular disease (127 patients), pulmonary disease (72), cardiovascular and pulmonary disease (23), functional state (24), malignant disorders (20), other (68), and unknown (eight). Patients were aged 37–93 years (mean 71). The maximum transverse diameter of the aorta was 56 mm (SD 11·5). Commercially manufactured devices were used in most patients (99%). The mean follow-up period was 12 months (range 0–60). 78 patients died within 30 days of surgery—59 (3%) who were fit for open surgery or anaesthesia, 15 (6%) who were unfit for open surgery, and four (4%) who were unfit for general anaesthesia. 56 patients unfit for open surgery or general anaesthesia died during follow-up, compared with 157 fit for surgery. The most common causes of death were cardiovascular disease (22 vs 55 patients), pulmonary disease (seven vs eight), and malignant disease (five vs 31). Only one patient died following rupture and the cause of death of two patients was unknown. The 1-year cumulative survival rates of patients fit and unfit for an open procedure, and those unfit for general anaesthesia differed significantly (each p=0·001, figure). The overall health status of patients was an important predictor of survival after endovascular repair. More than 20% of the high-risk patients died within 1 year, and they probably did not benefit from aneurysm repair. This high mortality corresponds with observations from other studies.3 Whether this finding was an additional effect of treatment or the result of the natural course of comorbidity is unclear. Reported annual rupture risks for aneurysms between 50 mm and 60 mm in patients with a poor medical condition varies from 3% to 12%.4 The attendant risks of endovascular abdominal aortic aneurysm repair might, therefore, exceed non-operative management. This issue is being addressed currently by a national randomised trial in the UK. Until the results of this trial are known, endovascular aneurysm repair in high-risk patients should be considered cautiously. The EUROSTAR data include the early experience of the contributors and a large proportion of first-generation endovascular devices.5 As clinicians gain more experience and the technology associated with endovascular repair evolves, better results can be anticipated. Our data reinforce the effect of selection of patients on results. When high-risk patients are being considered for aneurysm repair, the potential gain in longevity for the individual and whether or not this is deemed to be worthwhile is the most important factor to consider. 1
100 2
Cumulative proportion (%)
90 80
3
70 60
4
50 40
5
30
Patients fit for open surgery or anaesthesia Patients unfit for open surgery Patients unfit for anaesthesia
20 10 0 0
20 30 40 Follow-up (months) Kaplan-Meier curves for survival of patients
832
10
50
60
Ernst CB. Abdominal aortic aneurysm. N Engl J Med 1993; 328: 1167–72. Harris PL, Buth J, Mialhe C, Myhre HO, Norgen L. The need for clinical trials of endovascular abdominal aortic aneurysm stent-graft repair: the EUROSTAR-project. J Endovasc Surg 1997; 4: 72–77. Walker SR, Macierewics J, MacSweeney ST, et al. Mortality rates following endovascular repair of abdominal aortic aneurysms. J Endovasc Surg 1999; 6: 233–38. Jones A, Cahill D, Gardham R. Outcome in patients with a large abdominal aortic aneurysm considered unfit for surgery. Br J Surg 1998; 85: 1382–84. Cuypers Ph, Buth J, Harris PL, Gevers E, Laheij R, on behalf of the EUROSTAR Collaborators. Realistic expectations for patients with stent-graft treatment of abdominal aortic aneurysms: results of a European multicentre registry. Eur J Endovasc Surg 1999; 17: 507–16.
Department of Vascular Surgery, Catharina Hospital, PO Box 1350, 5602 ZA Eindhoven, Netherlands (R J F Laheij PhD, C J van Marrewijk MSc) Correspondance to: Dr Robert Laheij (e-mail: [email protected])
THE LANCET • Vol 356 • September 2, 2000
For personal use only. Not to be reproduced without permission of The Lancet.
Schanen C, Francke U. A severely affected male born into a Rett syndrome kindred supports X-linked inheritance and allows extension of the exclusion map. Am J Hum Genet 1998; 63: 267–69.
University Department of Medical Genetics and Regional Genetic Service, St Mary’s Hospital, Manchester M13 0JH, UK (J Clayton-Smith FRCP, P Watson BSc, S Ramsden PhD, G C M Black FRCOphth) and University Department of Ophthalmology, Manchester Royal Eye Hospital, Manchester (G C M Black FRCOphth) Correspondence to: Dr Jill Clayton-Smith
Endovascular stenting of abdominal aortic aneurysm in patients unfit for elective open surgery R J F Laheij, C J van Marrewijk, on behalf of the Eurostar group Endovascular aneurysm repair is useful for patients who are judged unfit for surgery. We investigated the outcome of endovascular repair of abdominal aortic aneurysm in patients fit and unfit for surgery. The 1-year cumulative survival for patients unfit for surgery and patients unfit for general anaesthesia was 20% and 23%, respectively. The overall health status of patients was an important predictor of survival after endovascular repair. The risks of endovascular aneurysm repair might, therefore, exceed that of non-operative management. Caution should be used when advising these patients about endovascular repair.
Endovascular stenting of abdominal aortic aneurysms, introduced at the beginning of the 1990s, is thought to be especially useful for patients unfit for elective surgery.1 In highrisk patients, however, just as in other types of patients, the decision to treat must be based on knowledge of the potential risks and benefits. We aimed to investigate and compare the outcome of endovascular repair of abdominal aortic aneurysms in patients in good medical condition with those who were judged unfit for open surgery or general anaesthesia. We obtained data on characteristics of patients, vascular risk factors, operative technical details, and outcome from the EUROpean collaborators registry on Stent-graft Techniques for abdominal aortic Aneurysm Repair (EUROSTAR).2 All patients received information about the registry and consented to have their data included in the study. Standard case-record forms were sent by the EUROSTAR organisation to participating institutions, who completed and returned them after the discharge of each patient and after each outpatient visit. Information from clinical examinations and imaging studies was obtained before and during the procedure, before discharge, at months 1, 3, 6, 12, 18, and 24, and yearly thereafter. The overall general medical condition of patients, as determined by the surgeon or anaesthetist at the different centres, was characterised on case-report forms as unfit for open surgery or unfit for anaesthesia. We recorded details of all
deaths and assessed mortality during follow-up by KaplanMeier survival analysis. Between 1994 and April 2000, 2442 patients with abdominal aortic aneurysms underwent endovascular repair in 80 institutions; 245 (10%) patients were unfit for open surgery and 97 (4%) were unfit for general anaesthesia. The main reasons for denying elective abdominal aortic aneurysm repair were: cardiovascular disease (127 patients), pulmonary disease (72), cardiovascular and pulmonary disease (23), functional state (24), malignant disorders (20), other (68), and unknown (eight). Patients were aged 37–93 years (mean 71). The maximum transverse diameter of the aorta was 56 mm (SD 11·5). Commercially manufactured devices were used in most patients (99%). The mean follow-up period was 12 months (range 0–60). 78 patients died within 30 days of surgery—59 (3%) who were fit for open surgery or anaesthesia, 15 (6%) who were unfit for open surgery, and four (4%) who were unfit for general anaesthesia. 56 patients unfit for open surgery or general anaesthesia died during follow-up, compared with 157 fit for surgery. The most common causes of death were cardiovascular disease (22 vs 55 patients), pulmonary disease (seven vs eight), and malignant disease (five vs 31). Only one patient died following rupture and the cause of death of two patients was unknown. The 1-year cumulative survival rates of patients fit and unfit for an open procedure, and those unfit for general anaesthesia differed significantly (each p=0·001, figure). The overall health status of patients was an important predictor of survival after endovascular repair. More than 20% of the high-risk patients died within 1 year, and they probably did not benefit from aneurysm repair. This high mortality corresponds with observations from other studies.3 Whether this finding was an additional effect of treatment or the result of the natural course of comorbidity is unclear. Reported annual rupture risks for aneurysms between 50 mm and 60 mm in patients with a poor medical condition varies from 3% to 12%.4 The attendant risks of endovascular abdominal aortic aneurysm repair might, therefore, exceed non-operative management. This issue is being addressed currently by a national randomised trial in the UK. Until the results of this trial are known, endovascular aneurysm repair in high-risk patients should be considered cautiously. The EUROSTAR data include the early experience of the contributors and a large proportion of first-generation endovascular devices.5 As clinicians gain more experience and the technology associated with endovascular repair evolves, better results can be anticipated. Our data reinforce the effect of selection of patients on results. When high-risk patients are being considered for aneurysm repair, the potential gain in longevity for the individual and whether or not this is deemed to be worthwhile is the most important factor to consider. 1
100 2
Cumulative proportion (%)
90 80
3
70 60
4
50 40
5
30
Patients fit for open surgery or anaesthesia Patients unfit for open surgery Patients unfit for anaesthesia
20 10 0 0
20 30 40 Follow-up (months) Kaplan-Meier curves for survival of patients
832
10
50
60
Ernst CB. Abdominal aortic aneurysm. N Engl J Med 1993; 328: 1167–72. Harris PL, Buth J, Mialhe C, Myhre HO, Norgen L. The need for clinical trials of endovascular abdominal aortic aneurysm stent-graft repair: the EUROSTAR-project. J Endovasc Surg 1997; 4: 72–77. Walker SR, Macierewics J, MacSweeney ST, et al. Mortality rates following endovascular repair of abdominal aortic aneurysms. J Endovasc Surg 1999; 6: 233–38. Jones A, Cahill D, Gardham R. Outcome in patients with a large abdominal aortic aneurysm considered unfit for surgery. Br J Surg 1998; 85: 1382–84. Cuypers Ph, Buth J, Harris PL, Gevers E, Laheij R, on behalf of the EUROSTAR Collaborators. Realistic expectations for patients with stent-graft treatment of abdominal aortic aneurysms: results of a European multicentre registry. Eur J Endovasc Surg 1999; 17: 507–16.
Department of Vascular Surgery, Catharina Hospital, PO Box 1350, 5602 ZA Eindhoven, Netherlands (R J F Laheij PhD, C J van Marrewijk MSc) Correspondance to: Dr Robert Laheij (e-mail: [email protected])
THE LANCET • Vol 356 • September 2, 2000
For personal use only. Not to be reproduced without permission of The Lancet.