Swedish Vascular Registry. Outcomes of endovascular abdominal aortic aneurysm repair compared with open surgical repair in high-risk patients: results from the Swedish Vascular Registry

Department of Vascular Surgery, Karolinska University Hospital, Stockholm, Sweden.
Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter (Impact Factor: 3.02). 10/2008; 48(6):1382-8; discussion 1388-9. DOI: 10.1016/j.jvs.2008.07.009
Source: PubMed


The management of infrarenal aortic aneurysms in high-risk patients remains a challenge. Endovascular aneurysm repair (EVAR) is associated with superior short-term mortality rates but unclear long-term results and has not been shown to improve survival in patients unfit for open repair (OR). The aim of this population-based study was to evaluate the outcome after elective EVAR compared with OR in a high-risk patient cohort.
Prospectively collected data from January 2000 to December 2006 were retrieved from the Swedish Vascular Registry. The high-risk cohort was defined as age >or=60 years, American Anesthesiologists Association (ASA) class 3 or 4, and at least one cardiac, pulmonary, or renal comorbidity. These criteria were met by 217 of 1000 EVAR patients and 483 of 2831 OR patients. Primary end points were 30-day and 1-year all-cause mortality. Kaplan-Meier curves for survival and multivariate Cox regression analyses were performed.
The crude 30-day and 1-year all-cause mortality rates for EVAR vs OR for the whole treatment group (n = 3831) were 1.8% vs 2.8% and 8.0% vs 7.2%, respectively. In the high-risk cohort (n = 700), EVAR patients were approximately 2 years older and renal insufficiency and diabetes mellitus were more common, and smoking was more prevalent in the OR group. About two-thirds of EVAR procedures were performed at university hospitals and one-half of OR procedures were performed at county hospitals. In the high-risk cohort, there was no difference in mortality at 30-days (EVAR, 4.6% vs OR, 3.3%), but OR had lower 1-year mortality (8.5% vs 15.9%; P = .003). More bleeding complications occurred in the EVAR group, but more pulmonary complications occurred in the OR group; however, there was no difference in cardiac, cerebrovascular, or renal complications. The mean follow-up was 3.4 years. EVAR was associated with increased mortality risk after adjusting for age, ASA class, and comorbidities (hazard ratio, 1.50; 95% confidence interval, 1.07-2.12; P = .02). Kaplan-Meier survival analysis showed a lower mortality rate for patients undergoing OR, which remained during follow-up (P = .001).
Elective OR of aortic aneurysms seems to have a better outcome compared with EVAR in this specific, population-based, high-risk patient cohort after adjusting for covariates. We cannot confirm the benefit of EVAR from previous registry studies with a similar high-risk definition. In clinical practice, OR may be at least as good as EVAR in high-risk patients fit for surgery.

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    ABSTRACT: Summary Endovascular abdominal aortic aneurysm repair (EVAR) has become an alternative method to open surgical repair of abdominal aortic aneurysm (AAA) since the early 90’s. In our center this method was used in 2003 for the first time. Aim of the Study: The aim of the single-center study is to evaluate 30 days and 1 year outcomes of EVAR of abdominal aortic aneurysm in the years 2003–2008. Materials and Methods: Between January 2003 and December 2008, 172 patients who had undergone elective EVAR were retrospectively analyzed. The interdisciplinary consensus among angiologist, interventional radiologist and vascular surgeon was reached to repair the aneurysm by EVAR. All patients underwent preoperative contrast-enhanced computed tomography (CT) to evaluate AAA anatomy. Tortuous iliac artery in CT was an indication to arteriography. Follow-up investigation included a clinical examination at 3, 6 and 12 months, duplex ultrasound scanning was performed at 3 and 6 months. Computed tomography (CT) scans were always performed at 1 and 12 months and in case of any abnormality on the duplex ultrasound scanning. Results: Stentgraft implantation was successful in 168 (97.5 %) of 172 attempted cases. 2 patients died because of circulatory insufficiency. 1 patient required conversion and 1 patient iliaco-iliaco bypass because of inability to deploy the stentgraft. Early complications included deaths and intraoperative device-related problems. There were 26 early complications (15 %) defined as occurring within 30 days after surgery. 12 months after the primary operation the control tests were carried out among 142 patients (82.5 %). There were 22 late complications among 142 patients, who received full followup. 7 patients died from unknown reasons. The hospital has lost track of other 30 patients. Conclusion: The method of endovascular technology is a technique to save lives of patients suffering from serious comorbidities. However, it is crucial to develop other, more effective methods in order to decrease the number of early and late complications. Zusammenfassung Die endovaskuläre Aneurysmatherapie stellt eine Alternative zum konventionellen Verfahren bei Bauchaortenaneurysma (BAA) dar. In unserem Krankenhaus wurde diese Methode zum ersten Mal im Jahr 2003 angewendet. Ziel: Das Ziel unserer Untersuchung war die Beurteilung der Ergebnisse der endovaskulären Aneurysmatherapie in 2003–2008 nach 30 Tagen und einem Jahr. Material und Methoden: Vom Januar 2003 bis Dezember 2008 erhielten 172 Patienten mit einem BAA gemeinsam durch Angiologen, Radiologen und Gefäßchirurgen eine endovaskuläre Aneurysmatherapie. Alle Patienten erhielten präoperativ eine Kontrastmittel-Computertomographie. Eine geschlängelte A. iliaca externa verlangte eine Angiographie. Die Funktion der Stentprothese wurde nach 3, 6 und 12 Monaten durch klinische Untersuchung, nach 3 und 6 Monaten durch eine Duplexsonographie und nach einem und 12 Monaten durch ein CT weiter kontrolliert. Auch bei Abnormalitäten in der Duplexsonographie wurde ein CT durchgeführt. Ergebnisse: Bei 168 Patienten von 172 Patienten (97,5 %) war die Stentimplantation erfolgreich. Zwei Patienten verstarben an Kreislaufinsuffizienz. Ein Patient verlangte eine Konversion zur chirurgischen Therapie und ein Patient einen iliakoiliakalen Bypass, weil sich bei ihm der kurze kontralaterale Schenkel nicht entfaltete. Frühkomplikationen berücksichtigten Todesfälle und intraoperative prothesenspezifische Komplikationen. Es waren 26 Frühkomplikationen (15 %), definiert als Komplikationen innerhalb von 30 Tagen, zu verzeichnen. Zwölf Monate nach der primären Operation hatten wir Kontakt mit 142 Patienten (82,5 %), bei denen 22 Spätkomplikationen aufgetreten waren. Sieben Patienten verstarben an unklarer Ursache. Schlussfolgerung: Die endovaskuläre Aneurysmatherapie ist eine lebensrettende Technik für Hochrisikopatienten. Allerdings ist es notwendig, noch bessere Methoden zu entwickeln, um die Anzahl der Komplikationen zu reduzieren.
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    ABSTRACT: In the trend of the endovascular revolution for occlusive arterial disease, management of aneurysmal disease has known an analogous change in the nineties. Elective endo-aneurysmal stentgrafting (EVAR or endovascular aneurysm repair) is nowadays of widespread application in contemporary practice all over the world, sometimes by over-enthusiast proponents. There is a burden of recent publications on that topic. Critical analysis of relevant data reveal compelling evidence that elective EVAR is a safe procedure with a threefold reduced 30-day morbidity-mortality, when compared to conventional open aneurysm repair. EVAR also deemed efficace in terms of AAA rupture prevention. At the other hand, mid-term follow-up revealed that EVAR does not endure at the long-term in any late survival benefit, compared to open AAA repair. The major concern and drawback of EVAR is its higher cost and the need for indefinite, life-long surveillance, with a 20% reintervention rate (almost catheter-based endovascularly) at 5-year follow-up. In this review-paper, short-term gains of EVAR are balanced against the inherent disadvantages and long-term losses. According best available evidence, EVAR should not longer be the first choice for high-risk patients, judged unfit for open aneurysm repair. There also exist doubt on the use of EVAR in young fit patients with an anticipated long life expectancy. In approximately half of the AAA patients, EVAR can be considered as the appropriate treatment option.
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