One-hundred Consecutive Physician-Modified Fenestrated Endovascular Aneurysm Repair of Pararenal and Thoracoabdominal Aortic Aneurysms Using the Terumo TREO Stent Graft.

BACKGROUND: Fenestrated endovascular aortic aneurysm repair (FEVAR) has been widely applied for the treatment of pararenal (PAA) and thoracoabdominal aortic aneurysms (TAAA). If custom-made devices or off-the-shelf devices are not available, physician-modified endografts (PMEGs) are an alternative device option. Several different endograft platforms have been used for PMEG; however, minimal data exists on utilizing the Terumo TREO abdominal stent graft system in this setting. The purpose of this study was to evaluate our single-center experience treating PAA and TAAA, with a physician-modified FEVAR, using the Terumo TREO platform. METHODS: A prospective database of consecutive patients with PAA and TAAA treated at a single center, with a FEVAR, utilizing a PMEG device between March 2021 and September 2023 was queried for those having a Terumo TREO device implanted. The demographics, operative details, and postoperative complications were analyzed. The rates of technical success, type I or III endoleak, branch vessel status, reintervention, and 2-year survival were also assessed. RESULTS: Of the 153 patients who underwent FEVAR with a PMEG device during the study period, 100 had repair using a Terumo TREO stent graft. The mean age of the cohort was 73.7 ± 7.0 years with the majority suffering from hypertension (n = 94, 94%), coronary artery disease (n = 51, 51%), and chronic obstructive pulmonary disease (n = 40, 40%). Thirty-four patients (34%) had a prior failed EVAR device in place. The mean aneurysm size was 66.0 ± 13.7 mm, with 58 (50%) patients classified as PAA and 30 (30%) patients as an extent IV TAAA. Six (6%) patients presented with symptomatic/ruptured aneurysms. The average number of target arteries incorporated per patient was 3.8 ± 0.6. The overall technical success was 99%, procedure time was 218 ± 116 min, contrast volume was 82 ± 21 mL, and cumulative air kerma was 3,054 ± 1,560 mGy. Postoperative complications were present in 20 patients (20%), and 2 patients (2%) died within 30 days. Rates of type I or III endoleak, branch vessel stenosis or occlusion, and reintervention were 2%, 1%, and 7%, respectively. The two-year overall survival was 87%. CONCLUSIONS: Treatment of PAA and the extent IV TAAA using a physician-modified fenestrated Terumo TREO endograft is safe and effective. This large, early experience using the Terumo TREO platform supports preferential use of this device in this setting due to the device design and low likelihood of type I or III endoleak.

Comparative outcomes of physician-modified fenestrated/branched endovascular aortic aneurysm repair in the setting of prior failed endovascular aneurysm repair.

OBJECTIVE: Endovascular treatment of aortic aneurysms involving renal-mesenteric arteries, especially in the setting of prior failed endovascular aneurysm repair (EVAR) typically requires fenestrated/branched endovascular aneurysm repair (F/BEVAR) with a custom-made device (CMD). CMDs are limited to select centers, and physician-modified endografts are an alternative treatment platform. Currently, there is no data on the outcomes of physician-modified F/BEVAR (PM-F/BEVAR) in the setting of failed prior EVAR. The purpose of this study was to evaluate the use of PM-F/BEVAR in patients with prior failed EVAR. METHODS: A prospective database of consecutive patients treated at a single center with PM-F/BEVAR between March 2021 and November 2022 was retrospectively reviewed. The cohort was stratified by presence of a failed EVAR (type Ia endoleak or aneurysm development proximal to a prior EVAR) prior to PM-F/BEVAR. Demographics, operative details, and postoperative complications were compared between the groups using univariate analysis. One-year survival and freedom from reintervention were compared using the Kaplan-Meier method. RESULTS: A total of 103 patients underwent PM-F/BEVAR during the study period; 27 (26%) were in the setting of prior EVAR. Patients with prior failed EVAR had similar age (75.2 ± 7.7 vs 71.5 ± 8.8 years; P = .058), male gender (n = 24 ; 89% vs n = 57 ; 75%; P = .130), and comorbid conditions except higher incidence of moderate-to-severe chronic obstructive pulmonary disease (n = 7 ; 26% vs n = 7 ; 9%; P = .047). Overall, aneurysm diameter was 65.5 ± 13.9 mm with aneurysms categorized as juxta-/pararenal in 43% and thoracoabdominal in 57%, with no differences between the groups. Twelve patients (14%) presented with symptomatic/ruptured aneurysms. The average number of target arteries incorporated per patient was 3.8. Four different aortic devices were modified with a greater proportion of Terumo TREO devices used in the failed EVAR group (P = .03). There was no difference in procedure time, radiation dose, or iodinated contrast use between groups. Overall technical success was 99%. Rates of 30-day mortality (n = 0 ; 0% vs n = 3 ; 4%; P = .565) and major adverse events (n = 6 ; 22% vs n = 16 ; 21%; P = 1.0) were similar between groups. For the overall cohort, rates of type 1 or 3 endoleak, branch vessel stenosis/occlusion, and reintervention were 2%, 1%, and 8%, respectively, with no difference between groups. One-year survival (failed EVAR 94% vs no EVAR 82%; P = .756) was similar between groups. CONCLUSIONS: PM-F/BEVAR is a safe and effective treatment for patients with aneurysms involving the renal-mesenteric arteries in the setting of prior failed EVAR where additional technical challenges may be present. Additional follow-up is warranted to demonstrate long-term efficacy, but early results are encouraging and similar to those using CMDs.

Safety and feasibility of a novel bi-directional portal vein access kit during transjugular intrahepatic portosystemic shunt creation.

BACKGROUND: Transjugular intrahepatic portosystemic shunt (TIPS) creation remains as one of the more technically challenging endovascular procedures. Portal vein access from the hepatic vein often requires multiple needle passes, which increases procedure times, risk of complications, and radiation exposure. With its bi-directional maneuverability, the Scorpion X access kit may be a promising tool for easier portal vein access. However, the clinical safety and feasibility of this access kit has yet to be determined. MATERIALS AND METHODS: In this retrospective study, 17 patients (12 male, average age 56.6 ± 9.01) underwent TIPS procedure using Scorpion X portal vein access kits. The primary endpoint was time taken to access the portal vein from the hepatic vein. The most common indications for TIPS were refractory ascites (47.1%) and esophageal varices (17.6%). Radiation exposure, total number of needle passes, and intraoperative complications were recorded. Average MELD Score was 12.6 ± 3.39 (range: 8-20). RESULTS: Portal vein cannulation was successfully achieved in 100% of patients during intracardiac echocardiography-assisted TIPS creation. Total fluoroscopy time was 39.31 ± 17.97 min; average radiation dose was 1036.76 ± 644.15 mGy, while average contrast dose was 120.59 ± 56.87 mL. The average number of passes from the hepatic vein to the portal vein was 2 (range: 1-6). Average time to access the portal vein once the TIPS cannula was positioned in the hepatic vein was 30.65 ± 18.64 min. There were no intraoperative complications. CONCLUSIONS: Clinical utilization of the Scorpion X bi-directional portal vein access kit is both safe and feasible. Utilizing this bi-directional access kit resulted in successful portal vein access with minimal intraoperative complications. LEVEL OF EVIDENCE: Retrospective cohort.

Experimental Analysis of Radiation Protection Offered by a Novel Exoskeleton-Based Radiation Protection System versus Conventional Lead Aprons.

PURPOSE: To evaluate the radiation protection offered by an exoskeleton-based radiation protection system (Stemrad MD) and to compare it with that offered by conventional lead aprons. METHODS: The experimental setup involved 2 anthropomorphic phantoms, an operator, a patient, and a C-arm as the x-ray radiation source. Thermoluminescent detectors were used to measure radiation doses to different radiosensitive body parts on the operator phantom both with the exoskeleton and a conventional lead apron at the left radial and right femoral positions. Detected radiation doses for the exoskeleton and lead apron for different body parts and positions were compared. RESULTS: At the left radial position, the mean radiation dose (mGy) reduction by the exoskeleton compared with that by the lead apron was >90% for the left eye lens (0.22 ± 0.13 vs 5.18 ± 0.08; P < .0001), right eye lens (0.23 ± 0.13 vs 4.98 ± 0.10; P < .0001), left head (0.11 ± 0.16 vs 3.53 ± 0.07; P < .0001), right head (0.27 ± 0.09 vs 3.12 ± 0.10; P < .0001), and left brain (0.04 ± 0.08 vs 0.46 ± 0.07; P < .0001). At the right femoral position, radiation reduction was >90% for the left eye lens (0.14 ± 0.10 vs 4.16 ± 0.09; P < .0001), right eye lens (0.06 ± 0.08 vs 1.90 ± 0.11; P < .0001), left head (0.10 ± 0.08 vs 4.39 ± 0.08; P < .0001), left brain (0.03 ± 0.07 vs 1.44 ± 0.08; P < .0001), right brain (0.00 ± 0.14 vs 0.11 ± 0.13; P = .06), and thyroid (0.04 ± 0.07 vs 0.27 ± 0.09; P < .0001). Protection of the torso was equivalent to that offered by conventional lead aprons. CONCLUSIONS: The exoskeleton-based system provided superior radiation protection to the physician compared with that provided by conventional lead aprons. The effects are particularly impactful for the brain, eye lens, and head areas.

StemRad MD, An Exoskeleton-Based Radiation Protection System, Reduces Ergonomic Posture Risk Based on a Prospective Observational Study.

OBJECTIVE: Poor ergonomic posture during interventional procedures might lead to increased physical discomfort and work-related musculoskeletal disorders. Adjunctive equipment such as lead aprons (LAs) has been shown to increase ergonomic posture risk (EPR). The objective of this study was to evaluate the effectiveness of StemRad MD (StemRad Ltd., Tel Aviv, Israel), a weightless exoskeleton-based radiation protective ensemble, in reducing EPR on the operator using wearable inertial measurement unit (IMU) sensors. METHODS: A prospective, observational study was conducted at an academic hospital. Inertial measurement unit sensors were affixed to the upper back of 9 interventionalists to assess ergonomic risk posture during endovascular procedures while wearing a traditional LA or the StemRad MD radiation protection system. Total fluoroscopy time, procedure type, and ergonomic risk postures were recorded and analyzed. RESULTS: Twenty-one cases were performed with StemRad MD and 30 with LAs. Mean procedure time for the StemRad MD procedures was 48.4±23.3 minutes (range: 24-106 min), and for LA procedures, it was 34.66±25.83 minutes (range: 6-100 min) (p=.060). The operators assumed low-risk ergonomic positions in 96.1% of StemRad MD cases and in 62.9% of LA cases (p=.001), and high-risk ergonomic positions in 0% and 6.2%, respectively (p=.80). Mean EPR score for StemRad MD was 1.16, and for the LA, it was 1.49 (p=.001). CONCLUSIONS: StemRad MD significantly reduces the EPR to the torso compared with a LA-based radiation protection system. CLINICAL IMPACT: Poor ergonomic posture during interventional procedures might leas to work-related musculoskeletal disorders for healthcare workers. StemRad MD, a weightless, exoskeleton-based radiation protection system was shown to significantly reduce ergonomic posture risk to the torso compared to conventional lead aprons. This might lead to reduced physical discomfort for procedure-based specialists.

Cloud-based fusion imaging improves operative metrics during fenestrated endovascular aneurysm repair.

OBJECTIVE: Endovascular treatment of complex aortic pathology has been associated with increases in procedural-related metrics, including the operative time and radiation exposure. Three-dimensional fusion imaging technology has decreased the radiation dose and iodinated contrast use during endovascular aneurysm repair. The aim of the present study was to report our institutional experience with the use of a cloud-based fusion imaging platform during fenestrated endovascular aneurysm repair (FEVAR). METHODS: A retrospective review of a prospectively maintained aortic database was performed to identify all patients who had undergone FEVAR with commercially available devices (Zenith Fenestrated; Cook Medical Inc, Bloomington, IN) between 2013 and 2020 and all endovascular aneurysm repairs performed using Cydar EV Intelligent Maps (Cydar Medical, Cambridge, UK). The Cydar EV cohort was reviewed further to select all FEVARs performed with overlay map guidance. The patient demographic, clinical, and procedure metrics were analyzed, with a comparative analysis of FEVAR performed without and with the Cydar EV imaging platform. Patients were excluded from comparative analysis if the data were incomplete in the dataset or they had a documented history of prior open or endovascular abdominal aortic aneurysm repair. RESULTS: During the 7-year study period, 191 FEVARs had been performed. The Cydar EV imaging platform was implemented in 2018 and used in 124 complex endovascular aneurysm repairs, including 69 consecutive FEVARs. A complete dataset was available for 137 FEVARs. With exclusion to select for de novo FEVAR, a comparative analysis was performed of 53 FEVAR without and 63 with Cydar EV imaging guidance. The cohorts were similar in patient demographics, medical comorbidities, and aortic aneurysm characteristics. No significant difference was noted between the two groups for major adverse postoperative events, length of stay, or length of intensive care unit stay. The use of Cydar EV resulted in nonsignificant decreases in the mean fluoroscopy time (69.3 ± 28 minutes vs 66.2 ± 33 minutes; P = .598) and operative time (204.4 ± 64 minutes vs 186 ± 105 minutes; P = .278). A statistically significant decrease was found in the iodinated contrast volume (105 ± 44 mL vs 83 ± 32 mL; P = .005), patient radiation exposure using the dose area product (1,049,841 mGy/cm2 vs 630,990 mGy/cm2; P < .001) and cumulative air kerma levels (4518 mGy vs 3084 mGy; P = .02) for patients undergoing FEVAR with Cydar EV guidance. CONCLUSIONS: At our aortic center, we have observed a trend toward shorter operative times and significant reductions in both iodinated contrast use and radiation exposure during FEVAR using the Cydar EV intelligent maps. Intelligent map guidance improved the efficiency of complex endovascular aneurysm repair, providing a safer intervention for both patient and practitioner.

Transgluteal approach to hypogastric artery aneurysm type II endoleak.

An enlarging internal iliac artery aneurysm secondary to a type II endoleak after endovascular aortic repair is an uncommon entity. It carries a significant rupture risk and mortality if not addressed. The present patient had had a 6.8-cm, rapidly growing, excluded hypogastric aneurysm. The results included both a failed transarterial approach and successful percutaneous transgluteal internal iliac artery aneurysm embolization using XperCT software (Philips Healthcare, Andover, MA) for guidance. The salient points included that treatment of the "nidus" alone will not be sufficient for complete endoleak embolization, the use of direct endoleak sac angiography might better delineate the inflow and outflow dynamics than conventional transarterial angiography, and XperCT guidance (Philips Healthcare) can facilitate complex endoleak access.

A case of spontaneous uterine artery pseudoaneurysm in a primigravid woman at 16 weeks gestation.

We report a case of a uterine artery pseudoaneurysm in a 29-year-old primigravid woman at 16 weeks gestation. The woman presented to the emergency room with lower left quadrant pain and vaginal bleeding. Ultrasound revealed a left adnexal mass consistent with a pseudoaneurysm. Percutaneous thrombin injection was chosen to avoid contrast and radiation risks to the fetus. Ultrasound demonstrated thrombosis of the pseudoaneurysm with no evidence of fetal distress. On postprocedure day 2, the patient presented again with similar complaints of lower quadrant pain and vaginal bleeding. The pseudoaneurysm was found to have recanalized and a decision was made to treat with computed tomography angiography and coil embolization. The procedure was successful, with angiography revealing an incidental branch of the pseudoaneurysm that was subsequently embolized.

Uterine artery pseudoaneurysm and embolisation during pregnancy.

Uterine artery pseudoaneurysm in pregnancy is a dangerous condition as rupture can be catastrophic due to the large volume of uterine blood flow. We present a case of a healthy, young woman with a desired pregnancy at 15 weeks of gestation incidentally discovered to have a pseudoaneurysm of the uterine artery during a routine prenatal ultrasound. She underwent initial thrombin injection followed by endovascular coil embolisation of the left uterine artery and carried the pregnancy to term without further complications.

Acute gouty arthritis following percutaneous cryoablation of renal cell carcinoma.

We report a case of acute gouty monoarthritis of the left ankle in a 58-year-old female with chronic renal insufficiency after cryoablation of a 3.8 cm left renal cell carcinoma. The patient's symptoms resolved after intravenous Solumedrol and did not recur at her 1-month follow-up visit. To the best of our knowledge, this is the first reported case of acute gouty monoarthritis after cryoablation of a renal cell carcinoma lesion in a patient with underlying chronic renal insufficiency. Clinicians should be vigilant of the potential for this complication in at-risk patient populations.

Positive Impact of an Aortic Center Designation.

BACKGROUND: In January 2015, we created a multidisciplinary Aortic Center with the collaboration of Vascular Surgery, Cardiac Surgery, Interventional Radiology, Anesthesia and Hospital Administration. We report the initial success of creating a Comprehensive Aortic Center. METHODS: All aortic procedures performed from January 1, 2015 until December 31, 2016 were entered into a prospectively collected database and compared with available data for 2014. Primary outcomes included the number of all aortic related procedures, transfer acceptance rate, transfer time, and proportion of elective/emergent referrals. RESULTS: The Aortic Center included 5 vascular surgeons, 2 cardiac surgeons, and 2 interventional radiologists. Workflow processes were implemented to streamline patient transfers as well as physician and operating room notification. Total aortic volume increased significantly from 162 to 261 patients. This reflected an overall 59% (P = 0.0167) increase in all aorta-related procedures. We had a 65% overall increase in transfer requests with 156% increase in acceptance of referrals and 136% drop in transfer denials (P < 0.0001). Emergent abdominal aortic cases accounted for 17% (n = 45) of our total aortic volume in 2015. The average transfer time from request to arrival decreased from 515 to 352 min, although this change was not statistically significant. We did see a significant increase in the use of air-transfers for aortic patients (P = 0.0041). Factorial analysis showed that time for transfer was affected only by air-transfer use, regardless of the year the patient was transferred. Transfer volume and volume of aortic related procedures remained stable in 2016. CONCLUSIONS: Designation as a comprehensive Aortic Center with implementation of strategic workflow systems and a culture of "no refusal of transfers" resulted in a significant increase in aortic volume for both emergent and elective aortic cases. Case volumes increased for all specialties involved in the center. Improvements in transfer center and emergency medical services communication demonstrated a trend toward more efficient transfer times. These increases and improvements were sustainable for 2 years after this designation.

Configuration affects parallel stent grafting results.

OBJECTIVE: A number of adjunctive "off-the-shelf" procedures have been described to treat complex aortic diseases. Our goal was to evaluate parallel stent graft configurations and to determine an optimal formula for these procedures. METHODS: This is a retrospective review of all patients at a single medical center treated with parallel stent grafts from January 2010 to September 2015. Outcomes were evaluated on the basis of parallel graft orientation, type, and main body device. Primary end points included parallel stent graft compromise and overall endovascular aneurysm repair (EVAR) compromise. RESULTS: There were 78 patients treated with a total of 144 parallel stents for a variety of pathologic processes. There was a significant correlation between main body oversizing and snorkel compromise (P = .0195) and overall procedural complication (P = .0019) but not with endoleak rates. Patients were organized into the following oversizing groups for further analysis: 0% to 10%, 10% to 20%, and >20%. Those oversized into the 0% to 10% group had the highest rate of overall EVAR complication (73%; P = .0003). There were no significant correlations between any one particular configuration and overall procedural complication. There was also no significant correlation between total number of parallel stents employed and overall complication. Composite EVAR configuration had no significant correlation with individual snorkel compromise, endoleak, or overall EVAR or procedural complication. The configuration most prone to individual snorkel compromise and overall EVAR complication was a four-stent configuration with two stents in an antegrade position and two stents in a retrograde position (60% complication rate). The configuration most prone to endoleak was one or two stents in retrograde position (33% endoleak rate), followed by three stents in an all-antegrade position (25%). There was a significant correlation between individual stent configuration and stent compromise (P = .0385), with 31.25% of retrograde stents having any complication. CONCLUSIONS: Parallel stent grafting offers an off-the-shelf option to treat a variety of aortic diseases. There is an increased risk of parallel stent and overall EVAR compromise with <10% main body oversizing. Thirty-day mortality is increased when more than one parallel stent is placed. Antegrade configurations are preferred to any retrograde configuration, with optimal oversizing >20%.

Early Experience with Snorkels and Chimneys for Expanding the Indications for Use of Endovascular Aneurysm Repair.

BACKGROUND: Although fenestrated and branched devices for juxtarenal and paravisceral aneurysms are available worldwide, limited ultrasound availability has perpetuated widespread utilization of adjunctive techniques for the endovascular treatment of these aneurysms. The objective of the study is to report on the technical feasibility and short-term durability of parallel grafts for juxtarenal and paravisceral aneurysms. METHODS: We performed a retrospective review of a prospectively collected endovascular aneurysm repair database, including all patients who underwent a parallel stent procedure. End points included were the following: (1) number of vessels snorkeled; (2) endoleaks; (3) morbidity and mortality; and (4) snorkel graft patency. RESULTS: Forty patients (85% male, mean 77.8 years) were treated for primary aneurysms (26), para-anastomotic aneurysms (6) following prior open repair, and endoleaks (8) following prior endovascular repair. Sixty-nine visceral vessels were preserved. Bilateral femoral arteries were accessed, as well as the left upper extremity via percutaneous (n = 5) brachial, open brachial (n = 15), or open axillary (n = 20) artery exposure with conduit. The mean length of surgery was 253 min with median intensive care unit stay of 2 days. There were 6 endoleaks noted, 8 access site complications, 1 perioperative death, and 3 branch vessel stent occlusions. We have a mean follow-up time of 17.6 months (range 3-44). CONCLUSIONS: Parallel stent-graft repair for paravisceral aneurysms is feasible and has acceptable technical/clinical success and complication rates. Although long-term follow-up is still needed, this technique fills the gap in endovascular options for poor open surgical candidates in whom fenestrated devices are not available.

Rapid aneurysm growth after transarterial chemoembolization.

Chemotherapy has been anecdotally related to aneurysm growth, but no correlation has been noted to date for localized transarterial chemoembolization. We present the case of a 64-year-old man with clearly documented accelerated aortic and iliac artery aneurysm dilation after two rounds of transarterial chemoembolization for hepatocellular carcinoma. Given the large size with rapid growth of his aneurysms and inability to be listed for transplant consideration before repair, he was offered endovascular repair and was successfully treated.

Treatment of type II endoleaks with ethylene-vinyl-alcohol copolymer (Onyx).

We report our single-center experience in treating 101 type II endoleaks with ethylene-vinyl-alcohol copolymer (EVOH, Onyx). In all, 65 endoleaks were embolized transarterially, and 36 were treated through a translumbar approach. Since the first transarterial embolization, when we began attempts to treat all patients initially via common femoral access, 58 (65.9%) of 88 patients were successfully embolized transarterially. All endoleaks in the translumbar group were successfully treated. At a median follow-up length of 15 weeks, a decrease or stabilization in aneurysm size was observed in 39 (73.6%) of the 53 endoleaks that had adequate follow-up computed tomography imaging. The overall residual endoleak rate was 34.0%. There was no difference in efficacy when comparing transarterial and translumbar approaches. We demonstrate that in most cases, transarterial access of the endoleak nidus is feasible, and controlled embolization is possible using EVOH. Furthermore, EVOH appears effective in long-term stabilization of aneurysm size and in preventing residual endoleaks.

32P as an adjunct to standard therapy for locally advanced unresectable pancreatic cancer: a randomized trial.

This prospective randomized trial was undertaken to determine the added efficacy of (32)P in treating locally advanced unresectable pancreatic cancer. Thirty patients with biopsy proven locally advanced unresectable adenocarcinoma of the pancreas were assessable after receiving 5-fluorouracil and radiation therapy with or without (32)P, followed by gemcitabine. Intratumoral (32)P dose was determined by tumor size and volume and was administered at months 0, 1, 2, 6, 7, and 8. Tumor cross-sectional area and liquefaction were determined at intervals by computed tomography scan. Tumor liquefaction occurred in 78% of patients receiving (32)P and in 8% of patients not receiving (32)P, although tumor cross-sectional area did not decrease. Serious adverse events occurred more often per patient for patients receiving (32)P (4.2 +/- 3.1 vs. 1.8 +/- 1.9; p = 0.03) leading to more hospitalizations. Death was because of disease progression (23 patients), gastrointenstinal hemorrhage (4 patients), and stroke (1 patient). One patient not receiving (32)P and one receiving (32)P are alive at 28 and 13 months, respectively. (32)P did not prolong survival (7.4 +/- 5.5 months with (32)P vs. 11.5 +/- 8.0 months without (32)P, p = 0.16). (32)P promoted tumor liquefaction, but did not decrease tumor size. Intratumoral (32)P was associated with more serious adverse events and did not improve survival for locally advanced unresectable pancreatic cancer.

Duplex scan surveillance after carotid angioplasty and stenting: a rational definition of stent stenosis.

OBJECTIVE: A duplex ultrasound (DUS) surveillance algorithm used after carotid endarterectomy (CEA) was applied to patients after carotid stenting and angioplasty (CAS) to determine the incidence of high-grade stent stenosis, its relationship to clinical symptoms, and the outcome of reintervention. METHODS: In 111 patients who underwent 114 CAS procedures for symptomatic (n = 62) or asymptomatic (n = 52) atherosclerotic or recurrent stenosis after CEA involving the internal carotid artery (ICA), DUS surveillance was performed 300 cm/s, diastolic velocity >125 cm/s, internal carotid artery stent/proximal common carotid artery ratio >4) involving the stented arterial segment prompted diagnostic angiography and repair when >75% diameter-reduction stenosis was confirmed. Criteria for >50% CAS stenosis was a PSV >150 cm/s with a PSV stent ratio >2. RESULTS: All 114 carotid stents were patent on initial DUS imaging, including 90 (79%) with PSV <150 cm/s (94 +/- 24 cm/s), 23 (20%) with PSV >150 cm/s (183 +/- 34 cm/s), and one with high-grade, residual stenosis (PSV = 355). During subsequent surveillance, 81 CAS sites (71%) exhibited no change in stenosis severity, nine sites demonstrated stenosis regression to <50% diameter reduction, and five sites developed velocity spectra of a high-grade stenosis. Angiography confirmed >75% diameter reduction in all six CASs with DUS-detected high-grade stenosis, all patients were asymptomatic, and treatment consisted of endovascular (n = 5) or surgical (n = 1) repair. During the mean 33-month follow-up period, three patients experienced ipsilateral, reversible neurologic events at 30, 45, and 120 days after CAS; none was associated with severe stent stenosis. No stent occlusions occurred, and no patient with >50% CAS stenosis on initial or subsequent testing developed a permanent ipsilateral permanent neurologic deficit or stroke-related death. CONCLUSION: DUS surveillance after CAS identified a 5% procedural failure rate due to the development of high-grade in-stent stenosis. Both progression and regression of stent stenosis severity was observed on serial testing, but 70% of CAS sites demonstrated velocity spectra consistent with <50% diameter reduction. The surveillance algorithm used, including reintervention for asymptomatic high-grade CAS stenosis, was associated with stent patency and the absence of disabling stroke.

TIPS versus peritoneovenous shunt in the treatment of medically intractable ascites: a prospective randomized trial.

OBJECTIVE: We undertook a prospective randomized clinical trial comparing TIPS to peritoneovenous (PV) shunts in the treatment of medically intractable ascites to establish relative efficacy and morbidity, and thereby superiority, between these shunts. METHODS: Thirty-two patients were prospectively randomized to undergo TIPS or peritoneovenous (Denver) shunts. All patients had failed medical therapy. RESULTS: After TIPS versus peritoneovenous shunts, median (mean +/- SD) duration of shunt patency was similar: 4.4 months (6 +/- 6.6 months) versus 4.0 months (5 +/- 4.6 months). Assisted shunt patency was longer after TIPS: 31.1 months (41 +/- 25.9 months) versus 13.1 months (19 +/- 17.3 months) (P < 0.01, Wilcoxon test). Ultimately, after TIPS 19% of patients had irreversible shunt occlusion versus 38% of patients after peritoneovenous shunts. Survival after TIPS was 28.7 months (41 +/- 28.7 months) versus 16.1 months (28 +/- 29.7 months) after peritoneovenous shunts. Control of ascites was achieved sooner after peritoneovenous shunts than after TIPS (73% vs. 46% after 1 month), but longer-term efficacy favored TIPS (eg, 85% vs. 40% at 3 years). CONCLUSION: TIPS and peritoneovenous shunts treat medically intractable ascites. Absence of ascites after either is uncommon. PV shunts control ascites sooner, although TIPS provides better long-term efficacy. After either shunt, numerous interventions are required to assist patency. Assisted shunt patency is better after TIPS. Treating medically refractory ascites with TIPS risks early shunt-related mortality for prospects of longer survival with ascites control. This study promotes the application of TIPS for medically intractable ascites if patients undergoing TIPS have prospects beyond short-term survival.

Patency of infrarenal aortic side branches determines early aneurysm sac behavior after endovascular repair.

In this study we sought to determine whether initial abdominal aortic aneurysm (AAA) sac anatomy, morphology, and side branch patency influence changes in aneurysm size and development of endoleak following endovascular repair. A blinded, retrospective review of preintervention CT scans and angiograms was conducted on 70 consecutive patients treated for infrarenal AAA (mean size 6.0 +/- 0.8 cm) by AneuRx stent-graft exclusion. Initial AAA diameter and side branch (inferior mesenteric artery [IMA], lumbar artery pair) patency, AAA clot/sac diameter ratio, wall thrombus and calcification distributions, attachment site anatomy, endograft size, and other clinical parameters were correlated with postoperative persistent side branch patency, presence of type II endoleak, and change in AAA diameter (increase/decrease ? 5 mm) using contingency table analyses. Patients underwent CT scanning and/or color duplex imaging at 1 month and at 3 (with endoleak) or 6 (without) month intervals postoperatively with 50 patients followed beyond 6 months (mean follow-up 11 +/- 7 months). The majority of patients possessed patent side branches prior to intervention (lumbar [n = 60, 86%], IMA [n = 45, 64%]). Development of type II endoleak or persistence of side branches could not be predicted (p > 0.05) from preoperative AAA side branch patency or any of the other initial anatomic AAA variables. On serial post-repair CT or duplex cans, 42% (19/45) of IMAs and 27% (16/60) of lumbar artery pairs remained patent. For patients followed beyond 6 months, type II endoleaks persisted in half (13/25) of the patients with patent side branches with roughly equal proportions fed by IMA and lumbar sources. Persistent side branches or presence of type II endoleak was associated with AAA expansion or the failure of aneurysm size diminution after endografting (p <0.01). Aneurysm sac regression was most likely in the absence of endoleak and patent side branches. We conclude that persistent side branch patency not only fuels development of type II endoleak but also influences early aneurysm sac behavior after endovascular repair. Optimal anatomic patient selection for endografting may not be possible on the basis of our initial experience, since preoperative AAA variables did not predict persistence of side branches or type II endoleaks.