Rajesh Malik

Five-year results for the Talent enhanced Low Profile System abdominal stent graft pivotal trial including early and long-term safety and efficacy

OBJECTIVES The pivotal trial of the Talent enhanced Low Profile System (eLPS; Medtronic Vascular, Santa Rosa, Calif) stent graft evaluated short and long-term safety and efficacy of endovascular aneurysm repair (EVAR). These data and a confirmatory group assessing the performance of the CoilTrac delivery system supported the United States premarket approval application for the device. METHODS The pivotal trial was a prospective, nonrandomized study conducted at 13 sites from February 2002 to April 2003. The study group (n = 166) underwent EVAR using the Talent eLPS stent graft. The control group (n = 243) underwent open surgical AAA repair. Data for this group were obtained from the Society for Vascular Surgery Endovascular AAA Surgical Controls project. Outcomes were compared at 30 days and 12 months. Additional 5-year follow-up was obtained for the eLPS group. A single-center cohort of 137 patients was the confirmatory group for the assessment of the clinical performance of the CoilTrac delivery system, with analysis of outcomes <or=30 days from the procedure. RESULTS AAA anatomy with neck length as short as 3 mm and maximum neck diameter of 32 mm were included in the eLPS group. EVAR was superior to open repair for periprocedural outcomes, including mean procedure duration (167.3 vs 196.4 minutes, P < .001), blood transfusion (18.2% vs 56.8%, P < .001), median intensive care unit stay (19.3 vs 74.3 hours, P < .001), and mean hospital stay (3.6 vs 8.2 days, P < .001). Freedom from major adverse events was 89.2% for EVAR at 30 days vs 44.0% (P < .001) and 81.3% vs 42.4% at 1 year (P < .001). Freedom from all-cause mortality and aneurysm-related mortality (ARM) was 93.7% and 98.2% for EVAR vs 92.4% and 96.7% for the controls. Through 5 years for the EVAR group, rates of freedom from all-cause mortality, ARM, aneurysm rupture, and conversion to surgery were 69.8%, 96.5%, 98.2%, and 99.1%, respectively, with one conversion to surgery, 25 secondary reinterventions, and five site-reported instances of stent graft migration. The technical success rate for the CoilTrac confirmatory group was 100%, with no aneurysm rupture or conversion to open repair at 30 days. The 30-day all-cause mortality rate was 1.5% (2 of 137). CONCLUSIONS In a population with challenging anatomic characteristics, EVAR with the Talent eLPS and use of the CoilTrac delivery system compared favorably with open repair through 1 year. Sustained protection from ARM, with minimal reinterventions, was attained through 5 years.

Outcome of elective endovascular abdominal aortic aneurysm repair in octogenarians and nonagenarians

OBJECTIVE Compared to open repair of abdominal aortic aneurysms (AAA), endovascular aneurysm repair (EVAR) is associated with decreased perioperative morbidity and mortality. This study sought to examine the outcomes of EVAR in patients >or=80 years of age. METHODS This was a retrospective review from a prospectively maintained computerized database. A total of 322 patients aged >or=80 underwent elective EVAR from January 1997 to November 2007. Mean age was 84 years +/- 3.4 years (range, 80-95 years), and 78.5% were male. Mean aneurysm size was 62 mm +/- 12 mm (range, 39-110 mm). RESULTS Mean procedural blood loss was 350 mL (range, 50-2700 mL), and 13.9% required intraoperative transfusion. Mean length of postoperative stay was 2.46 days (median, 1 day; range, 1-42 days), with 54.3% of patients discharged on the first postoperative day. There were 25 (7.8%) perioperative major adverse events. The most common were categorized as device-related (6), cardiac (4), gastrointestinal (4), and bleeding/hematoma (3). The perioperative 30-day mortality rate was 3.1% (10 of 322). Mean follow-up was 25.7 months (range, 1-110 months). Overall, 47 patients (14.6%) required secondary intervention, 7 patients (2.2%) underwent conversion to open repair, and 4 patients (1.2%) died from AAA rupture. Endoleaks occurred in 95 patients (29.4%), with 20 type I, 48 type II, and 27 of indeterminate type; of these, 10 patients with type I endoleaks underwent secondary intervention. Freedom from all-cause mortality at 1 year was 84.3% and at 5 years was 27.4%. Freedom from aneurysm-related mortality at 5 years was 92.9%. CONCLUSION EVAR in octogenarians is associated with high procedural success and low perioperative morbidity and mortality. The midterm results of this study support the use of EVAR in this patient population. Further studies are needed to predict short-term and long-term mortality risk, and treatment for other causes of death.

Predicting embolic potential during carotid angioplasty and stenting: Analysis of captured particulate debris, ultrasound characteristics, and prior carotid endarterectomy

INTRODUCTION Extracranial carotid stenoses exhibit significant variance in embolic potential, with restenotic lesions having a particularly low propensity for embolization. This study sought to identify characteristics associated with increased generation of embolic debris during carotid angioplasty and stenting (CAS). METHODS Captured particulate was available for analysis in 56 consecutive patients. Demographics were mean age, 74 years (range, 60-94 years); mean stenosis, 88% (range, 70%-99%); symptomatic, 27%; prior carotid endarterectomy (CEA), 27%; prior radiotherapy, 7%. Plaque echogenicity, heterogenicity, ulceration, and irregularity were assessed with B-mode duplex ultrasound analysis. Gray scale median (GSM) was calculated from normalized B-mode VHS video recordings. Calcification and degree of stenosis were determined angiographically. Captured particulate debris was evaluated for total number; number >200 microm, >500 microm, >1000 microm; mean and median size. Hematoxylin and eosin, trichrome, and von Kossa stains were used for histologic analysis of captured material. RESULTS Restenotic carotid stenoses after prior CEA generated minimal embolic debris compared with primary stenoses. Four of 15 patients (27%) with restenotic lesions demonstrated embolic particles; all debris was <500 microm. All 41 patients with primary stenoses had some embolic debris; particulate size was >200 microm in 91%, >500 microm in 72%, and >1000 microm in 43%. In primary lesions, the number and size of captured particulate correlated with GSM and with the combined ultrasound findings of echogenicity, heterogenicity, and luminal irregularity/ulceration (P < .02, 95% confidence interval, 4.5-27.6). None of these ultrasound factors correlated independently with embolic particulate (P = NS). Patients aged >70 years exhibited more total particles (8.1 vs 2.3, P = .008) and increased mean particle size (370 vs 157 mum, P = .02). No significant correlation was observed between the number and size of captured embolic particulate and any other variable (stenosis percentage, prior radiotherapy, preprocedural symptoms, periprocedural symptoms, and calcification). Histologically, the embolic debris consisted of extensive amorphous, acellular proteinaceous material. Calcium debris in the embolic particulate was associated with heavily and moderately calcified lesions. CONCLUSIONS Considerable variation exists in the number and size of embolic particles generated during CAS. Embolic potential is positively correlated with lesion GSM and the combination of lesion echogenicity, heterogenicity, and irregularity. Restenosis after prior CEA is associated with minimal embolic particulate generation, suggesting that embolic protection may not be necessary for CAS of restenotic lesions.

The effect of a hospitalist comanagement service on vascular surgery inpatients

OBJECTIVE Vascular surgery patients have increased medical comorbidities that amplify the complexity of their care. We assessed the effect of a hospitalist comanagement service on inpatient vascular surgery outcomes. METHODS We divided 1059 patients into two cohorts for comparison: 515 between January 2012 and December 2012, before the implementation of a hospitalist comanagement service, and 544 between January 2013 and October 2013, after the initiation of a hospitalist comanagement service. Nine vascular surgeons and 10 hospitalists participated in the hospitalist comanagement service. End points measured were in-hospital mortality, length of stay (LOS), 30-day readmission rates, visual analog scale pain scores (0-10), inpatient adult safety assessments using the Agency for Healthcare Research and Quality (AHRQ) Patient Safety Indicators, and resident perceptions assessed by survey. RESULTS The in-hospital mortality rate decreased from 1.75% to 0.37% after the implementation of the hospitalist comanagement service (P = .016), with a decrease in the observed-to-expected ratio from 0.89 to 0.22. The risk-adjusted in-hospital mortality decreased from 1.56% to 0.0008% (P = .003). Mean LOS was lower in the base period, at 5.1 days vs 5.5 days (P < .001), with an observed-to-expected ratio of 0.83 and 0.78, respectively. The risk-adjusted LOS increased from 4.2 days to 4.3 days (P < .001). The overall 30-day readmission rate was unchanged, at 23.1% compared with 22.8% (P = .6). The related 30-day readmission rate was also similar, at 11.5% compared with 11.4% (P = .5). Patients reporting no pain during hospitalization increased from 72.8% before the hospitalist comanagement service to 77.8% after (P = .04). Reports of moderate pain decreased from 14% to 9.6% (P = .016). Mild and severe pain scores were similar between the two groups. Adult safety measured by AHRQ demonstrated a decrease from three to zero patients in the number of deaths among surgical patients with treatable complications (P = .04). Most house staff reported that the comanagement program had a positive effect on patient care and education. CONCLUSIONS The hospitalist comanagement service has resulted in a significant decrease in in-hospital mortality rates, patient safety, as measured by AHRQ, and improved pain scores. Resident surveys demonstrated perceived improvement in patient care and education. Continued observation will be necessary to assess the long-term effect of the hospitalist comanagement service on quality metrics.

Early Results for Below-Knee Bypasses Using Distaflo

In patients who require lower extremity revascularization, prosthetic graft is a reasonable alternative in the absence of a suitable autologous vein conduit. However, prosthetic bypass grafts have limited patency, especially for infrageniculate reconstruction. Polytetrafluoroethylene grafts were geometrically modified at the distal end to increase their patency. The authors reviewed their experience with the Distaflo graft in patients who required lower extremity below-knee popliteal and tibial bypasses when no suitable autologous vein conduit was available. Chart review was conducted of the 57 patients who underwent 60 lower extremity bypasses over a 3-year period between June 2003 and April 2006. Twenty-four revascularizations were constructed to the tibial outflow sites, whereas the remaining grafts were placed to the below-knee (28) and above-knee (8) popliteal artery, respectively. Study endpoints were primary, assisted primary, secondary patency, and limb salvage at the time of follow-up. Distaflo bypass was performed at the infrageniculate level in 86.7% of cases (28 below-knee popliteal, 24 tibial). Mean follow-up time was 12 months (range, 0.5-37.5 months). At 1 year, primary, assisted primary, and secondary patencies and limb salvage rates for below-knee popliteal bypasses were 83.5%, 89.5%, 94.7%, and 94.4%, respectively. Primary, assisted primary, and secondary patencies and limb salvage rates for tibial bypasses were 44.4%, 44.4%, 63.2%, and 74.9%, respectively. Distaflo precuffed graft is a good alternative conduit for below-knee popliteal and tibial lower extremity reconstructions in the absence of an autologous vein and appears to have promising early patency and limb salvage rates even when used for tibial bypasses.

Tips and techniques in carotid artery stenting

Significant technical advances have made carotid artery stenting an option for high-risk patients. These advances bring forth new challenges that must be overcome. Preprocedural planning is essential for optimal outcome for every patient given the high risk for significant neurologic complications. In this article we describe a standard approach for performing carotid artery stenting and techniques used to circumvent challenges that may be encountered. In addition, implementation of modifications and advanced techniques in challenging cases may allow successful treatment of carotid stenosis. Maintenance of proficiency in carotid artery stenting requires significant and ongoing experience.

Staged hybrid open and endovascular exclusion of a symptomatic thoracoabdominal aortic aneurysm in a high-risk patient

Thoracoabdominal aortic aneurysms have a higher prevalence in the elderly, who are often poor surgical candidates. These extensive aneurysms may be lethal if left untreated. Conventional open repair has proven to be a major task, involving cardiopulmonary bypass, aortic cross-clamping and expeditious repair of an inaccessible structure involving two body cavities. Endovascular repair has become a viable option to treat isolated descending thoracic aneurysms and infrarenal abdominal aortic aneurysms. However, endovascular techniques alone have been less applicable for treating complex aortic aneurysms, including those involving visceral vessels. Therefore, a hybrid open and endovascular approach with visceral debranching has become an increasingly favorable alternative for patients with these complex conditions. We report a case in which a staged hybrid approach was used for successful exclusion of an extensive thoracoabdominal aortic aneurysm in a symptomatic, high-risk patient who would not have been an appropriate candidate for open surgical repair.