Alex Powell

Risk Stratification and Outcomes of Transluminal Endografting for Abdominal Aortic Aneurysm: 7-Year Experience and Long-term Follow-up

PURPOSE To determine early and late outcomes of transluminal endografting (TE) in patients with abdominal aortic aneurysm (AAA), stratified by predicted risk of procedure-related mortality with conventional operation. MATERIALS AND METHODS A retrospective study was conducted in consecutive risk-stratified AAA patients undergoing TE at a not-for-profit cardiovascular referral center from March 1994 through November 2000 with follow-up through February 2001. With use of conventional risk strata (0 = low, 1 = minimal, 2 = moderate, and 3 = high), predicted procedure-related mortalities were 0%-1% in stratum 0 (n = 40), 1%-3% in stratum 1 (n = 118), 3%-8% in stratum 2 (n = 116), and 8%-30% in stratum 3 (n = 31). Main outcome measures were: (i) TE procedural success, (ii) procedure-related mortality, (iii) major nonfatal complications, (iv) composite adverse outcome (ii + iii), (v) length of stay (LOS), (vi) freedom from AAA rupture, (vii) late survival, (viii) late complications, and (ix) endoleaks and their classification and management. RESULTS Women were significantly less likely than men to qualify for and undergo endografting: 24 of 91 (26.4%) women underwent TE, compared to 281 of 684 (41.1%) men. Of 305 attempted TE procedures, 291 (95.4%) were successful, four (1.3%) were urgently converted to open repair, and 10 (3.3%) were aborted. Procedure-related mortalities occurred in eight cases (2.6%) overall and one of 40 (2.5%), one of 118 (0.8%), four of 116 (3.4%), and two of 31 (6.5%) cases for risk strata 0-3, respectively. Perioperative survivors were significantly younger than nonsurvivors (74.3 y +/- 9 vs 81.6 y +/- 5.1; P =.0087). Forty-six patients (15.1%) had major complications. Composite adverse outcome was worse for patients in stratum 3 than those in stratum 1 (P =.0296) and those in strata 0, 1, and 2 combined (P =.026). Procedure-related mortality declined with institutional experience, from 4% among the first 100 patients undergoing TE to 1% among the last 105. For strata 0-3, median LOS were 2, 3, 3, and 4 days, respectively. Seventy patients (22.9%) had 75 endoleaks, of which 30 necessitated additional procedures, 17 self-resolved, and 22 were untreated as of March 1, 2001. Five patients with endoleak died of unrelated causes. One late-onset type IA endoleak (26 mo) resulted in the only AAA rupture and death in the follow-up period among the 291 patients who underwent successful transluminal endograft implantation. Actuarial survival rates at 1 year after TE were 90.3% +/- 1.9% for the overall study group and 97.5% +/- 2.5%, 94% +/- 2.5%, 86.9% +/- 3.3%, and 81.3% +/- 7.7% for risk strata 0-3, respectively. At 5 years, overall actuarial survival was 69.6% +/- 6.1%. Thirty-eight late deaths were attributable to post-TE AAA rupture (n = 1), AAA rupture late after failed TE with no further treatment (n = 1), other cardiovascular disorders (n = 7), cancer (n = 15), other causes (n = 10), and unknown causes (n = 4). Late deaths occurred in risk strata 0-3 at the following rates: two of 40 (5%), 10 of 118 (8.5%), 16 of 116 (13.8%), and 10 of 31 (32.3%), respectively (stratum 0 vs stratum 3, P =.0017; stratum 1 vs stratum 3, P =.003). CONCLUSIONS TE is safe and confers durable protection against AAA rupture in treated populations. Still, protection is not absolute in patients with endoleaks, because late AAA enlargement and even rupture can occur. Given current knowledge, technology, and practice, careful patient selection and close surveillance of patients after implantation of transluminal endografts is essential.

Initial results of reteplase in the treatment of acute lower extremity arterial occlusions.

PURPOSE To assess the feasibility and efficacy of reteplase in transcatheter arterial thrombolysis for lower extremity occlusive disease. MATERIALS AND METHODS Fifteen consecutive patients with acute lower extremity ischemia due to occlusive disease were treated by means of catheter-directed thrombolysis with reteplase. Following diagnostic angiography, thrombolysis was started either from an antegrade puncture site in cases of femoropopliteal occlusions, or from the contralateral groin in cases of thrombosis of the iliac artery, common femoral artery, or infrainguinal bypass grafts. Reteplase was infused at a rate of either 0.5 U/h (six patients) or 1.0 U/h (nine patients). RESULTS Complete thrombolysis was achieved in all of the nine (100%) patients in the 1.0 U/h group and in four of six (66%) patients in the 0.5 U/h group for a combined success rate of 13 of 15 (87%). Clinical success was achieved in 11 of 15 patients overall (73%). Major bleeding complications occurred in none of the 9 patients in the 1.0 U/h group and in one (16%) of the six patients in the 0.5 U/h group for an overall rate of 6%. CONCLUSIONS Reteplase shows promise as an alternative to urokinase in the treatment of lower extremity ischemia due to arterial occlusive disease.

The Influence of Female Gender on the Outcome of Endovascular Abdominal Aortic Aneurysm Repair

PURPOSE Women appear to have a greater risk of death than men after open surgery for abdominal aortic aneurysm (AAA). The aim of this study is to compare outcomes after endovascular AAA repair in men and women. MATERIALS AND METHODS From March 1994 to November 2000, 305 patients (281 men and 24 women) underwent AAA repair with use of endovascular techniques. Outcomes measured included perioperative mortality, percentage of procedures aborted or converted to open abdominal AAA repair, deployment success rate, angiographic success rate, major complication rate, and percentage of patients with endoleaks. RESULTS Patients of both genders were comparable with respect to mean age (74.4 in men vs 75.9 in women; NS). According to the Society for Vascular Surgery/International Society of Cardiovascular Surgery risk stratification method, men and women were also comparable in age risk score (0.60 vs 0.67; NS), pulmonary risk score (0.50 vs 0.83; NS), and renal risk score (0.28 vs 0.17; NS). However, the cardiac risk score was higher in men (1.31 vs 0.80; P <.05) and maximum AAA diameter was greater in men (57.0 mm vs 52.1 mm; P <.01). Eight perioperative deaths (2.6%) occurred (2.8% of men, 0% of women; NS). Proportionately more procedures were aborted in women than men: four (16.7%) versus six (2.1%; P <.01). Conversion to open repair occurred in four men (1.4%) and no women (NS). Deployment success was achieved in 96.4% of men and 83.3% of women (P <.01). Angiographic success was achieved in 84.1% of men and 80% of women (NS). Of 46 major complications, 42 (14.9%) occurred in 281 men and four (16.7%) occurred in 24 women (NS). Sixty-seven patients had endoleaks: 60 were men (22.1%) and seven were women (35%; NS). CONCLUSIONS There was no difference between men and women with respect to perioperative mortality and major complication rates. These findings indicate that being a woman does not adversely influence the outcome of endovascular AAA repair. However, women had a higher rate of aborted procedures. Precise preoperative evaluation may help reduce this problem in women.

Bivalirudin as an Anticoagulation Agent: Safety and Efficacy in Peripheral Interventions

PURPOSE Traditionally, unfractionated heparin is used to prevent thrombotic complications in peripheral interventions. The purpose of this study is to evaluate the use of bivalirudin as the anticoagulant agent for peripheral interventions. MATERIALS AND METHODS A retrospective analysis of 108 patients who underwent 110 peripheral interventions between January 2002 and January 2004 and received bivalirudin as the sole anticoagulation agent was conducted at Baptist Cardiac and Vascular Institute. Interventions were performed in the following areas: iliac, femoropopliteal, and distal (n = 55), carotid (n = 31), vertebral (n = 1), renal (n = 14), aorta (n = 7), and subclavian (n = 2). The following procedural and clinical endpoints were examined: death, requirement of urgent surgery or surgery during the same admission, urgent percutaneous revascularization in the same treated vessel, thrombotic or embolic events, bleeding events, and groin complications. RESULTS A total of 266 lesions were dilated in 185 arteries. There were no procedural mortalities, procedural success was 99.1%, and the complication rate was 3.6%. There was one embolic stroke (0.9%), one thrombosis (0.9%), and two groin hematomas (1.8%). No patient required urgent surgery or reintervention in the same treated vessel. No complications were noted at 7 days after the procedure. There were two interventions by postprocedure day 30: toe amputation and groin debridement. CONCLUSION Bivalirudin is a safe alternative to unfractionated heparin as the anticoagulation agent in peripheral interventions. This study shows that the complication profile is comparable to other bivalirudin studies. Bivalirudin is effective, easy to use, and is associated with few bleeding complications.

Ultrasound-accelerated vs Standard Catheter-directed Thrombolysis—A Comparative Study in Patients with Iliofemoral Deep Vein Thrombosis

PURPOSE To compare the thrombolytic efficacy and safety of standard catheter-directed thrombolysis (CDT) and ultrasound (US)-accelerated thrombolysis (UAT) for the treatment of iliofemoral deep vein thrombosis (DVT). MATERIALS AND METHODS All medical records of patients who underwent CDT or UAT for DVT between June 2004 and October 2011 at a single tertiary care center were reviewed. Target vein patency was graded according to a reporting standard by an independent interventional radiologist. RESULTS CDT was performed in 19 patients and UAT in 64 patients. The baseline parameters and DVT characteristics, including the duration of symptoms, the location, and the extension did not differ significantly between groups. Both treatment modalities were associated with a similar substantial resolution of thrombus load (CDT = 89%; interquartile range [IQR], 70%-100%; UAT = 82%; IQR, 55%-92% (P = .560). No significant differences in the lytic drug infusion rates, the total lytic doses, the total infusion time, and the use of adjunctive procedures were observed between groups. Major and minor bleeding complications were observed in 8.4% and 4.8% of the patients, with no difference between the treatment groups (P = .709 and P = .918, respectively). During a median follow-up of 35 months (20-55 months), three deaths and 16 cases of repeated thrombosis were observed. The estimated mean event-free survival time was longer after CDT (69 mo) compared with UAT (33 mo) (log-rank test P = .310). CONCLUSIONS The present study failed to prove any substantial clinical benefit provided by UAT with regard to effectiveness or safety compared with standard CDT. Given the added costs of the US delivery device, prospective randomized data are needed to justify its widespread use for DVT treatment.

The Reentry Catheter: A Second Chance for Endoluminal Reentry at Difficult Lower Extremity Subintimal Arterial Recanalizations

From January 2005 to July 2008, a retrospective study was conducted at a single institution to investigate technical success of the use of a reentry device (Outback LTD reentry catheter) in aortoiliac and femoropopliteal artery recanalization in 34 patients (18 men; mean age +/- SD, 72 years +/- 11) in whom the conventional guide wires and catheters failed to reenter the true lumen. True lumen reentry was achieved in 87% (n = 23) and 91% (n = 11) of patients with femoropopliteal and aortoiliac occlusions, respectively. The overall technical success rate with the device was 88% (n = 34). The device success rate in Transatlantic Inter-Society Consensus II class D lesions was significantly lower than in lower lesion classes (71.4% vs 100%; P < .05). No procedure-related complications were encountered. In conclusion, the use of the reentry catheter enhances the likelihood of successful subintimal recanalization of chronic occlusions in femoropopliteal and aortoiliac arteries.

The DENALI Trial: An Interim Analysis of a Prospective, Multicenter Study of the Denali Retrievable Inferior Vena Cava Filter

PURPOSE To assess safety and effectiveness of a nitinol retrievable inferior vena cava (IVC) filter in patients who require caval interruption to protect against pulmonary embolism (PE). MATERIALS AND METHODS Two hundred patients with temporary indications for an IVC filter were enrolled in this prospective, multicenter clinical study. Patients undergoing filter implantation were to be followed for 2 years or for 30 days after filter retrieval. At the time of the present interim report, all 200 patients had been enrolled in the study, and 160 had undergone a retrieval attempt or been followed to 6 months with their filter in place. Primary study endpoints included technical and clinical success of filter placement and retrieval. Patients were also evaluated for recurrent PE, new or worsening deep vein thrombosis, and filter migration, fracture, penetration, and tilt. RESULTS Clinical success of placement was achieved in 94.5% of patients (172 of 182), with a one-sided lower limit of the 95% confidence interval of 90.1%. Technical success rate of filter placement was 99.5%. Technical success rate of retrieval was 97.3%; 108 filters were retrieved in 111 attempts. In two cases, the filter apex could not be engaged with a snare, and one device was engaged but could not be removed. Filter retrievals occurred at a mean indwell time of 165 days (range, 5-632 d). There were no instances of filter fracture, migration, or tilt greater than 15° at the time of retrieval or 6-month follow-up. CONCLUSIONS In this interim report, the nitinol retrievable IVC filter provided protection against pulmonary embolism, and the device could be retrieved with a low rate of complications.

Influence of Stent Type on Hemodynamic Depression after Carotid Artery Stent Placement

PURPOSE To assess the effect of stent type on hypotension and bradycardia after carotid artery stent placement. MATERIALS AND METHODS A retrospective analysis on a prospectively maintained database was conducted in 256 patients (126 men; mean age, 71.8 years +/- 8.6; 194 de novo lesions) undergoing carotid artery stent placement between January 1996 and January 2007 by using self-expanding stents. Braided Elgiloy stents (Wallstents) were used in 44 of the 256 patients (17.2%) and slotted-tube nitinol stents were deployed in 212 (82.8%). Bivariate and multivariable logistic regression models were used to determine the influence of stent design on procedural and 24-hour hypotension and bradycardia. RESULTS Procedural hemodynamic depression (HD) was encountered in 73 of the 256 patients (28.5%) due to hypotension in 24 (9.4%), bradycardia in 12 (4.7%), or both in 37 (14.5%) patients. Rates of procedural hypotension were 11.3% with nitinol stents and 0% with braided Elgiloy stents (P = .0188). Persistent postprocedural HD occurred in 91 of the 256 patients (35.5%) due to hypotension in 40 patients (15.6%), bradycardia in 23 (9.0%), or both in 28 (10.9%). Within a multivariable analysis adjusted for clinically relevant factors affecting rates of HD, the use of braided Elgiloy stents was associated with a decreased rate of procedural hypotension (odds ratio: 0.165; 95% confidence interval: 0.038, 0.721; P = .017). Procedural hypotension and bradycardia were not correlated to incidence of major adverse events but were associated with an increased duration of hospital stay (P = .0059 and P = .0335, respectively). CONCLUSIONS Nitinol stents are associated with a higher risk of hypotension as compared to braided Elgiloy stents during carotid artery stent placement.

Imaging of endoleaks.

The endovascular repair of abdominal aortic aneurysms is gaining widespread acceptance worldwide. It relies on the exclusion of the aneurysm sac from arterial pressure/blood flow to reduce the pressure within it and therefore prevent the fatal complication of rupture. The presence of an endoleak is clear evidence that communication between the native circulation and the aneurysm sac persists. Unfortunately, direct measurement of the sac pressure is not a practical or safe method for routine detection or follow-up of endoleaks. Therefore, a fast, safe, sensitive, and reproducible method must be available. Although many imaging modalities have been and continue to be investigated, computed tomography angiography remains the gold standard. This article describes the various modalities used for the detection of endoleaks and discusses their imaging characteristics.

Postoperative management: type I and III endoleaks.

The purpose of this article is to help the reader understand the importance of imaging findings and treatment strategies for type I and III endoleaks. Although the appearance of these leaks on computed tomography can be somewhat unremarkable and similar in appearance to type II endoleaks, it is critically important for the treating physician to make the correct diagnosis, as these endoleak types signify an incompletely treated aneurysm. Once the diagnosis of a type I or III endoleak is made, the next step in treatment is to identify the cause of the endoleak. Incomplete initial graft expansion, further arterial dilation, endograft migration, component separation, and tears within the graft fabric are all possible causes of type I and III endoleaks. A combination of computed tomography, plain film radiography, and diagnostic angiography may be necessary to make the diagnosis and identify the underlying cause of the complication. Once all of these factors have been determined, a decision has to be made of whether the endoleak can be treated through additional endovascular means or if endovascular therapy has failed for the patient, making open surgical revision necessary to treat the aneurysm. Illustrative cases of all endoleak types and their treatments are the focus of this article.