Implications from neurologic assessment of brain protection for total arch replacement from a randomized trial.

OBJECTIVE: The study objective was to perform a randomized trial of brain protection during total aortic arch replacement and identify the best way to assess brain injury. METHODS: From June 2003 to January 2010, 121 evaluable patients were randomized to retrograde (n = 60) or antegrade (n = 61) brain perfusion during hypothermic circulatory arrest. We assessed the sensitivity of clinical neurologic evaluation, brain imaging, and neurocognitive testing performed preoperatively and 4 to 6 months postoperatively to detect brain injury. RESULTS: A total of 29 patients (24%) experienced neurologic events. Clinical stroke was evident in 1 patient (0.8%), and visual changes were evident in 2 patients; all had brain imaging changes. A total of 14 of 95 patients (15%) undergoing both preoperative and postoperative brain imaging had evidence of new white or gray matter changes; 10 of the 14 patients had neurocognitive testing, but only 2 patients experienced decline. A total of 17 of 96 patients (18%) undergoing both preoperative and postoperative neurocognitive testing manifested declines of 2 or more reliable change indexes; of these 17, 11 had neither imaging changes nor clinical events. Thirty-day mortality was 0.8% (1/121), with no neurologic deaths and a similar prevalence of neurologic events after retrograde and antegrade brain perfusion (22/60, 37% and 15/61, 25%, respectively; P = .2). CONCLUSIONS: Although this randomized clinical trial revealed similar neurologic outcomes after retrograde or antegrade brain perfusion for total aortic arch replacement, clinical examination for postprocedural neurologic events is insensitive, brain imaging detects more events, and neurocognitive testing detects even more. Future neurologic assessments for cardiovascular procedures should include not only clinical examination but also brain imaging studies, neurocognitive testing, and long-term assessment.

A direct comparison of early and late outcomes with three approaches to carotid revascularization and open heart surgery.

OBJECTIVES: The aim of this study was a comparison of risk-adjusted outcomes of 3 approaches to carotid revascularization in the open heart surgery (OHS) population. BACKGROUND: Without randomized clinical trials, the best approach to managing coexisting severe carotid and coronary disease remains uncertain. Staged carotid endarterectomy (CEA) followed by OHS or combined CEA and OHS are commonly used. A recent alternative is carotid artery stenting (CAS). METHODS: From 1997 to 2009, 350 patients underwent carotid revascularization within 90 days before OHS at a tertiary center: 45 staged CEA-OHS, 195 combined CEA-OHS, and 110 staged CAS-OHS. The primary composite endpoint was all-cause death, stroke, and myocardial infarction (MI). Staged CAS-OHS patients had higher prevalence of previous stroke (p = 0.03) and underwent more complex OHS. Therefore, the propensity score adjusted multiphase hazard function models with modulated renewal to account for staging, and competing risks were used. RESULTS: Using propensity analysis, staged CAS-OHS and combined CEA-OHS had similar early hazard phase composite outcomes, whereas staged CEA-OHS incurred the highest risk driven by interstage MI. Subsequently, staged CAS-OHS patients experienced significantly fewer late hazard phase events compared with both staged CEA-OHS (adjusted hazard ratio: 0.33; 95% confidence interval: 0.15 to 0.77; p = 0.01) and combined CEA-OHS (adjusted hazard ratio: 0.35; 95% confidence interval: 0.18 to 0.70; p = 0.003). CONCLUSIONS: Staged CAS-OHS and combined CEA-OHS are associated with a similar risk of death, stroke, or MI in the short term, with both being better than staged CEA-OHS. However, the outcomes significantly favor staged CAS-OHS after the first year.

The contemporary management of splenic artery aneurysms.

OBJECTIVES: The management of patients with splenic artery aneurysms (SAAs) is variable since the natural history of these aneurysms is poorly delineated. The objective of this study was to review our experience with open repair, endovascular therapy, and observation of SAAs over a 14-year interval. METHODS: Between January 1, 1996 and December 31, 2009, 128 patients with SAAs were evaluated. Sixty-two patients underwent surgical repair (n = 13) or endovascular coil/glue ablation (n = 49), while 66 patients underwent serial observation. The original medical records and computed tomography (CT) imaging were reviewed. Statistical analyses were performed using χ(2) or Fisher's exact test for categorical patient characteristics and t-test for continuous variables. Kaplan-Meier estimates for survival were calculated. Mortality was verified via the Social Security Death Index. RESULTS: Patients (61 ± 11 years, 69% female) were investigated for abdominal symptoms (49%) or had the incidental finding of SAA (mean size, 2.4 ± 1.4 cm). Seven patients (5.5%) presented with rupture and were treated emergently with two perioperative mortalities (29%). Patients requiring surgical or endovascular treatment were more likely male (40% vs 21%, P = .031), younger (58 vs 64 years; P = .004), and current smokers (18% vs 5%; P = .035). Increased aneurysm calcification was associated with decreased SAA size (P = .013). The mean aneurysm size at initial diagnosis was 1.67 cm for patients undergoing observation and 3.13 cm for the treated group (P < .001). Endovascular repair was safe and durable with a mean 1.5-mm regression in SAA size over 2 years. The mean rate of growth for observed SAA was 0.2 mm/y. Ten-year survival was 89.4% (95% confidence interval: 82.0, 97.4) for all patients (observed group, 94.9%; treated group, 85.1%; P = .18). No late aneurysm-related mortality was identified. CONCLUSIONS: Ruptured SAAs are lethal. Large SAAs can undergo endovascular ablation safely with durable SAA regression. Smaller SAAs (<2 cm) grow slowly and carry a negligible rupture risk.

The management of severe aortoiliac occlusive disease: endovascular therapy rivals open reconstruction.

OBJECTIVE: Aortobifemoral bypass (ABF) grafting has been the traditional treatment for extensive aortoiliac occlusive disease (AIOD). This retrospective study compared the outcomes and durability of recanalization, percutaneous transluminal angioplasty, and stenting (R/PTAS) vs ABF for severe AIOD. METHODS: Between 1998 and 2004, 86 patients (161 limbs) underwent ABF (n = 75) or iliofemoral bypass (n = 11), and 83 patients (127 limbs) underwent R/PTAS. All patients had severe symptomatic AIOD (claudication, 53%; rest pain, 28%; tissue loss, 12%; acute limb ischemia, 7%). The analyses excluded patients treated for aneurysms, extra-anatomic procedures, and endovascular treatment of iliac stenoses. Original angiographic imaging, medical records, and noninvasive testing were reviewed. Kaplan-Meier estimates for patency and survival were calculated and univariate analyses performed. Mortality was verified by the Social Security database. RESULTS: The ABF patients were younger than the R/PTAS patients (60 vs 65 years; P = .003) and had higher rates of hyperlipidemia (P = .009) and smoking (P < .001). All other clinical variables, including cardiac status, diabetes, symptoms at presentation, TransAtlantic Inter-Society Consensus stratification, and presence of poor outflow were similar between the two groups. Patients underwent ABF with general anesthesia (96%), often with concomitant treatment of femoral or infrainguinal disease (61% endarterectomy, profundaplasty, or distal bypass). Technical success was universal, with marked improvement in ankle-brachial indices (0.48 to 0.84, P < .001). Patients underwent R/PTAS with local anesthesia/sedation (78%), with a 96% technical success rate and similar hemodynamic improvement (0.36 to 0.82, P < .001). At the time of R/PTAS, 21% of patients underwent femoral endarterectomy/profundaplasty or bypass (n = 5) for concomitant infrainguinal disease. Limb-based primary patency at 3 years was significantly higher for ABF than for R/PTAS (93% vs 74%, P = .002). Secondary patency rates (97% vs 95%), limb salvage (98% vs. 98%), and long-term survival (80% vs 80%) were similar. Diabetes mellitus and the requirement of distal bypass were associated with decreased patency (P < .001). Critical limb ischemia at presentation (tissue loss, hazard ratio [HR], 8.1; P < .001), poor outflow (HR, 2; P = .023), and renal failure (HR, 2.5; P = .02) were associated with decreased survival. CONCLUSION: R/PTAS is a suitable, less invasive alternative to ABF for the treatment of severe AIOD. Repair of the concomitant femoral occlusive disease is often needed regardless of open or endovascular treatment. Infrainguinal disease negatively affects the durability of the procedure and patient survival.

Evolution of carotid stenting: regulatory issues.

Although carotid angioplasty and stenting have been performed for more than 20 years, the regulations surrounding its performance have remained a controversial issue. Intervention in the cerebral vascular bed is the only area in which regulations have limited the applicability of interventional techniques to vascular disease. Whether or not this is the correct approach remains to be seen, but knowledge of the regulations and requirements surrounding the performance of carotid stenting are of paramount importance for those performing these procedures. A review of the regulations affecting everything from the institutions to the physicians performing these procedures, as outlined in this article, will be helpful in clarifying for physicians and institutions what is mandated before performing carotid intervention.