Major Procedure-related Complications Research Articles

A prospective, multicenter study of a double stent system for palliative treatment of malignant extrahepatic biliary obstructions.

A double stent system (covered stent in uncovered stent) was designed to provide long-term patency without tumor ingrowth or stent-related complications, such as stent migration, cholecystitis, or pancreatitis. To investigate the safety and efficacy of double stents in patients with malignant extrahepatic biliary obstructions. This prospective, nonrandomized, multicenter study enrolled 160 consecutive patients (102 men; mean age, 64 years; range, 33-91 years) with malignant extrahepatic biliary obstructions treated with a double stent system from January 2010 to March 2012. The technical success rate of the double stent placement was 100%. No stent migration was observed. Procedure-related minor (self-limiting hemobilia [n = 6] and cholangitis [n = 2]) and major (pancreatitis [n = 16], cholecystitis [n = 3], and hepatic abscess [n = 2]) complications occurred in a total of 29 patients. The mean serum bilirubin level, which was 8.9 ± 5.6 mg/dL before drainage, decreased to 2.2 ± 4.6 mg/dL 1 month after stent placement (P < 0.001). Successful internal drainage was achieved in 148 patients (92.5%). During the mean follow-up period of 205 days, acute cholecystitis (n = 3) and hepatic abscess (n = 2) occurred in five patients. The median patient survival and stent patency time were 135 days (95% confidence interval [CI], 96-160 days) and 114 days (95% CI, 83-131 days), respectively. Of 153 patients, 22 (14.4%) presented with stent dysfunction due to sludge incrustation (n = 17), tumor overgrowth (n = 4), or blood clot (n = 1), and required repeat intervention. Tumor ingrowth was not observed in any of these patients. Percutaneous treatment of malignant extrahepatic biliary obstruction using a double stent safely and effectively achieves internal biliary drainage.

Predictors of Long-Term Survival Following Transvenous Extraction of Defibrillator Leads.

Little data exist on long-term outcomes following extraction of implantable cardioverter defibrillator (ICD) leads, particularly for noninfectious indications. We sought to identify predictors of long-term survival after ICD lead extraction. We retrospectively reviewed ICD lead extractions at our institution (n = 508). Procedural outcomes and long-term survival were ascertained by medical records review. Indication for lead extraction was infection in 32.5% and lead failure in 61.8%. Mean dwell time of the oldest extracted lead was 5.1 ± 5.9 years. Complete procedural success was achieved in 96.5% of cases. Major procedure-related complications occurred in 1.6% with six periprocedural deaths. During a mean follow-up of 866 ± 798 days, survival was significantly worse among patients with infection as the indication for extraction. At 1 year after extraction, survival among those with infection was 88.2%, compared to 95.0% in the lead failure cohort (P < 0.001). Procedural failure was a significant predictor of long-term mortality, even after excluding periprocedural deaths. In multivariate models, the presence of chronic kidney disease, increased number of leads requiring extraction, lower ejection fraction, and procedural failure were predictors of mortality. Despite high rates of procedural success, infectious indication for ICD lead extraction is associated with increased long-term mortality. In contrast, among patients undergoing extraction for lead failure, long-term survival was excellent. The presence of procedural failure was a significant predictor of long-term mortality. Further studies will be necessary to better understand the mechanisms by which procedural failure may adversely impact long-term outcomes.

Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT): Initial Results From a Prospective Multicenter Registry

Systemic thrombolysis for acute pulmonary embolism (PE) carries up to a 20% risk of major bleeding, including a 2% to 5% risk of hemorrhagic stroke. We evaluated the safety and effectiveness of catheter-directed therapy (CDT) as an alternative treatment of acute PE. One hundred one consecutive patients receiving CDT for acute PE were prospectively enrolled in a multicenter registry. Massive PE (n = 28) and submassive PE (n = 73) were treated with immediate catheter-directed mechanical or pharmacomechanical thrombectomy and/or catheter-directed thrombolysis through low-dose hourly drug infusion with tissue plasminogen activator (tPA) or urokinase. Clinical success was defined as meeting all the following criteria: stabilization of hemodynamics; improvement in pulmonary hypertension, right-sided heart strain, or both; and survival to hospital discharge. Primary safety outcomes were major procedure-related complications and major bleeding events. Fifty-three men and 48 women (average age, 60 years [range, 22-86 years]; mean BMI, 31.03 ± 7.20 kg/m2) were included in the study. The average thrombolytic doses were 28.0 ± 11 mg tPA (n = 76) and 2,697,101 ± 936,287 International Units for urokinase (n = 23). Clinical success was achieved in 24 of 28 patients with massive PE (85.7%; 95% CI, 67.3%-96.0%) and 71 of 73 patients with submassive PE (97.3%; 95% CI, 90.5%-99.7%). The mean pulmonary artery pressure improved from 51.17 ± 14.06 to 37.23 ± 15.81 mm Hg (n = 92) (P < .0001). Among patients monitored with follow-up echocardiography, 57 of 64 (89.1%; 95% CI, 78.8%-95.5%; P < .0001) showed improvement in right-sided heart strain. There were no major procedure-related complications, major hemorrhages, or hemorrhagic strokes. CDT improves clinical outcomes in patients with acute PE while minimizing the risk of major bleeding. At experienced centers, CDT is a safe and effective treatment of both acute massive and submassive PE. ClinicalTrials.gov; No.: NCT01097928; URL: www.clinicaltrials.gov.

Minimally invasive salvage therapy for transplanted renal allografts

Purpose: To evaluate the effectiveness of interventional therapy for complications of transplanted renal allografts. Materials and methods: Between January 2009 and March 2014, 14 patients underwent interventional therapy for complications of renal allografts. Complications included transplant renal artery stenosis (TRAS), TRAS combined with pseudoaneurysms, transplant renal venous kinking and ureteral obstruction (UO). Serum creatinine (S.Cr) levels were evaluated before and after procedure. The characteristics and procedure outcomes of these patients with vascular and nonvascular complications were also analyzed. Results: All primary procedures were successfully performed, which included percutaneous transluminal angioplasty (PTA) for TRAS (n = 4), stenting and coil embolization for TRAS combined with pseudoaneurysms (n = 1), stenting for renal vein kinking (n = 2), and percutaneous nephrostomy (PCN) for UO (n = 7) and secondary antegrade stent placement in six UO patients after 1 week of PCN. No major procedure related complications occurred. S.Cr level subsequently improved from 6.0 ± 3.6 to 2.6 ± 2.1 mg/dL (p < 0.001), as well as patients’ clinical features within 1 week after procedure. In our study, the onset time of vascular complications was earlier (<6 months) than nonvascular complications with significant difference (p < 0.001). During follow-up, the patient with TRAS and pseudoaneurysms suffered acute rejection 1 month after treatment and received transplant renal artery embolization. One patient with TRAS showed restenosis 4 months after procedure, and was retreated successfully with stenting. Thirteen cases reserved their transplanted renal allografts. Conclusion: Interventional therapy could be prior considered for transplanted renal allograft complications as its effectiveness and minimal invasiveness in saving the transplanted renal grafts.

Minimally Invasive Percutaneous Treatment of Small Renal Tumors with Irreversible Electroporation: A Single-Center Experience

PurposeTo evaluate whether irreversible electroporation (IRE) can be used as an ablation technique for small renal tumors (T1a cancers or small benign tumors) and to describe features after ablation on computed tomography (CT) or magnetic resonance (MR) imaging. Materials and MethodsIn this retrospective study, 20 patients (mean age, 65 y ± 12.8 y) underwent CT-guided IRE of T1a renal carcinoma (n = 13) or small benign or indeterminate renal masses < 4 cm in size (n = 7). Mean tumor size was 2.2 cm ± 0.7. The ablation area was verified with contrast-enhanced imaging performed immediately after the procedure to determine technical success. Imaging was performed 6 weeks (20 of 20 patients), 6 months (15 of 20), and 12 months (6 of 20) after ablation. Medical records and CT/MR imaging features of all patients were reviewed for recurrence, symptoms, and complications after treatment. ResultsTechnical success was achieved in all patients (100%); there were no major procedure-related complications. Minor complications occurred in 7 patients, including self-limiting perinephric hematomas, pain difficult to control, and urinary retention. Mean procedure time was 2.0 hours ± 0.7. At 6 weeks, 2 patients required salvage therapy because of incomplete ablation. At 6 months, all 15 patients with imaging studies available had no evidence of recurrence. At 1 year, 1 patient (1 of 6) was noted to have experienced recurrence. CT/MR imaging after IRE ablation demonstrated an area of nonenhancement in the treatment zone that involuted over ~6 months. ConclusionsRenal IRE appears to be a safe treatment for small renal tumors. Tumors treated with IRE demonstrated nonenhancement in the treatment zone with involution on follow-up CT/MR imaging.

Left Atrial Appendage Occlusion Device and Novel Oral Anticoagulants Versus Warfarin for Stroke Prevention in Nonvalvular Atrial Fibrillation: Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Nonvalvular atrial fibrillation is the most common arrhythmia. Patients with nonvalvular atrial fibrillation are at increased risk of stroke; therefore, we evaluated the efficacy and safety of different approaches to prevent this major complication. We conducted electronic database searches of phase III randomized controlled trials. The groups were novel oral anticoagulants, Watchman left atrial appendage occlusion device (DEVICE), and warfarin. Efficacy outcomes were stroke or systemic embolism, and all-cause mortality. Safety outcome was major bleeding and procedure-related complications. A subgroup analysis of the elderly population was done. We used random-effects model to compare pooled outcomes and tested for heterogeneity. Odds ratios (ORs) and 95% confidence intervals (CIs) were computed for each outcome. Seven randomized controlled trials (n=73,978) were included. There was a significant difference favoring novel oral anticoagulants for systemic embolism (OR, 0.84; 95% CI, 0.72-0.97; P=0.01), all-cause mortality (OR, 0.89; 95% CI, 0.84-0.94; P<0.001), and safety outcomes (OR, 0.79; 95% CI, 0.65-0.97; P=0.026) compared with warfarin. No difference was seen between DEVICE and warfarin for efficacy end points; however, DEVICE had more complications (OR, 1.85; 95% CI, 1.14-3.01; P=0.012). In the elderly (6 randomized controlled trials, n=30,699), systemic embolism was favored with novel oral anticoagulants over warfarin (OR, 0.77; 95% CI, 0.68-0.87; P≤0.001). No evidence of significant publication bias was found. Novel oral anticoagulants is superior to warfarin for stroke prevention in nonvalvular atrial fibrillation. This benefit was also observed in the elderly population. DEVICE is a reasonable noninferior alternative to warfarin for stroke prevention, but cautious use is essential given safety concerns.

Non-contrast cardiac resynchronization therapy implantation is feasible in case of renal insufficiency

Renal insufficiency (RI) is frequent in patients eligible for cardiac resynchronization therapy (CRT) and may be worsened by the use of contrast agents. We sought to determine the feasibility of CRT implantation without contrast injection in patients with contraindication to iodine. Patients eligible for CRT and presenting with RI were prospectively included (non-contrast NC group). A contemporary control group (CG) of CRT patients with contrast injection was used for comparison. An over-the-wire coronary sinus (CS) lead with an angled distal tip was selected for this "blind harpooning" technique. Seventeen patients in the NC group were included (78 ± 7 years). Serum creatinine was 208 ± 86 μmol/L (glomerular filtration rate 33 ± 15 mL/min/1.73 m(2)). CG included 25 patients (70 ± 7 years, serum creatinine 85 ± 21 μmol/L). CRT implantation was successful in 16/17 patients (94.1 %) without contrast injection. The mean procedure and fluoroscopy times were similar in the two groups: 146 ± 29 in the NC group versus 153 ± 25 min (p = 0.57) and 25 ± 12 in the NC group versus 23 ± 16 min (p = 0.7) respectively. The mean CS lead implantation time was 36 ± 19 (NC group) versus 39 ± 15 min (p = 0.64). No major procedure-related complications were observed in both groups. CRT implantation is feasible in the majority of the cases (94.1 %) without contrast injection and without lengthening the procedure time in patients with RI.

PTU-331 Day case oesophageal self expanding metallic stent (sems) placement is safe and saves bed days:

<h3>Introduction</h3> SEMS is an accepted endoluminal palliative treatment for symptom control in patients with oesophageal cancer. Current practice of SEMS placement including techniques, pre and post procedure care varies widely across the UK; with many hospitals admitting patients both pre and post procedure.¹ <h3>Aim</h3> To evaluate the safety and effectiveness of day case SEMS placement for oesophagogastric cancer. <h3>Method</h3> Retrospective case note review of all patients undergoing SEMS placement from Jan 2012 to Dec 2014 was performed. Day case patients were admitted to the endoscopy unit in the morning, standard consent and sedation procedures was followed. SEMS inserted under radiological and endoscopic or endoscopic guidance alone. Patients were monitored for 1.5–2 hrs post procedure, nurse led discharge with a prescription for oral liquid opiates, antiemetics and Proton pump inhibitors. All had telephonic access to a dedicated cancer specialist nurse during working hours and on call team out of hours. Inpatients needing stenting followed similar protocol for post-procedure care. Relevant outcomes data was collected and statistical analyses were performed on GraphPad Prism Version 6 and Epi Info 7. <h3>Results</h3> 138 procedures were carried out on 127 patients (41 women, 86 men) with a median age 78.2 (IQR 69–83.25, Range 52–96). 93 patients had adenocarcinoma, 26 squamous cell carcinoma, 6 extrinsic compression and 2 benign diseases. SEMS deployment was successfully achieved in all 138 procedures, 79 as day case (DC) and the rest 59 as inpatients (IP). Median stent length used was comparable in the groups DC 11 cm (IQR 10–12), IP 11 cm (IQR 10–12.5). Good dysphagia alleviation was obtained in both groups (dysphagia scores: IP cohort pre-stent 2.7 ± 0.16, post-stent 0.57 ± 0.66 P &lt; 0.001; DC cohort pre-stent 2.63 ± 0.11, post-stent 0.48 ± 0.17 P &lt; 0.001). Median survival was 136 days (IQR 43–171) in IP group and 125 days (IQR 29.65–183.5) in DC group. DC cohort reported more post procedure pain requiring analgesia and reflux symptoms as compared to IP. Bleeding (minor), stent migration and 30 day mortality was comparable in the two groups. No major procedure related complications reported. <h3>Conclusion</h3> SEMS placement as day case is safe and complication rates and mortality is equivalent to inpatients. In our hospital, the basic cost of a general medical hospital bed day is £330, thereby equating to a £26000 in total cost saving per day of admission in bed cost. Day case SEMS produced a reduction in hospital admissions and hospital bed day occupancy with major cost savings. <h3>Disclosure of interest</h3> None Declared. <h3>Reference</h3> The Royal College of Surgeons of England, National Oesophago-gastric Cancer Audit, 2013

Percutaneous placement of peritoneal dialysis catheters in resource-limited developing countries as an alternative to conventional placement methods

Background: The percutaneous placement of peritoneal dialysis (PD) catheters using conscious sedation with ultrasound and fluoroscopic guidance is underutilised and has several advantages over the open surgical and laparoscopic placement methods, especially in the resource-limited developing world. Objectives: To describe our patients’ demographics and clinical characteristics, our method of PD catheter placement within the Radiology Department at Kimberley Provincial Hospital, compare our early complication types and frequencies, overall peritonitis rate and one-year catheter survival rate with findings in the international literature and, by demonstrating comparable outcomes, propose that percutaneous placement be considered as a feasible alternative to conventional placement techniques. Method: We conducted a retrospective study on 25 patients who had their PD catheters inserted between January 2009 and May 2013. Medical records were reviewed for demographic and clinical information as well as type and frequency of early (within 30 days) and late (between 30 days and one-year) complications related to the PD catheter. Early complication types and frequencies were then compared with similar internationally published data. The overall peritonitis rate, in terms of episodes per patient-year, was calculated and compared with international recommendations, and our one-year catheter survival rate was calculated using the Kaplan Meier method and compared with similarly calculated international studies.Results: The study group comprised 16 male and 9 female patients with a median age of 44 years. Hypertension was the primary cause of end-stage renal disease (ESRD), and was found in 10 (40%) patients. Our early exit site infection rate of 12% was slightly higher than that found in the literature. Literature varies on the overall infection rates; however, our overall peritonitis rate of 0.75 episodes per patient-year was higher than that recommended by the International Society of Peritoneal Dialysis. This finding might be attributed to the lower socio-economic grouping of our patients and the small number in the study group. All but two peritonitis cases were successfully treated with antibiotics, and we had no major procedure-related complications. Our early peritonitis rate of 8%, as well as the other early complication types and rates, and our one-year catheter survival rate of 84%, compared favourably with international studies. Conclusion: Percutaneous PD catheter placement under conscious sedation with the aid of ultrasound and fluoroscopy is a sound alternative to conventional methods in the resourcelimited developing world.

Characteristics and Diagnostic Yield of Pediatric Colonoscopy in Taiwan

Colonoscopy of the lower gastrointestinal tract has diagnostic and therapeutic value. This retrospective study aimed to investigate the indications, complications, and diagnostic yield of diagnostic colonoscopy among Taiwanese children. The application of colonoscopy performed on children aged < 18 years between 1998 and 2010 in a referral tertiary center in Southern Taiwan was reviewed. Data on age, gender, indications, complications, and colonoscopic and final diagnoses were collected and analyzed. One hundred and ninety-two children with 201 colonoscopies and 27 sigmoidoscopies were enrolled. The rate of successful ileocecal approach was 77.5%. The most common indication was lower gastrointestinal bleeding (LGIB; 53.5%), followed by chronic abdominal pain (20.6%), iron deficiency anemia (IDA; 11.8%), and chronic diarrhea (11.4%). There were 144 patients (75%) with a conclusive diagnosis in their first colonoscopy, including nonspecific colitis (23.4%), polyp (20.4%), and inflammatory bowel disease (8.3%). The diagnostic yields of colonoscopy according to the major indications were 77.3% in LGIB, 68.1% in chronic abdominal pain, 66.7% in IDA, and 79.2% in chronic diarrhea. Among the patients with LGIB, juvenile polyp (26.4%) was the most common etiology. There were no major procedure-related complications. LGIB is the most common indication for pediatric colonoscopy. Pediatric colonoscopy is most effective in diagnosing pediatric LGIB and chronic diarrhea.

Major complications due to transjugular liver biopsy: Incidence, management and outcome

The purpose of this study was to retrospectively evaluate the incidence of intraperitoneal bleeding and other major complications of transjugular liver biopsy (TJLB) and analyze their outcome and management. The clinical files of 341 consecutive patients who had TJLB were retrospectively analyzed. There were 237 men and 104 women (mean age: 51.38±12.8 years; range: 17-89 years). All patients had TJLB because standard percutaneous transhepatic biopsy was contraindicated. Patients' files were reviewed to search for major and minor procedure-related complications during or immediately after TJLB. TJLBs were technically successful in 331/341 patients (97.07%; 95%CI: 94.67-98.58%). Major complications consisted exclusively of intraperitoneal bleeding due to liver capsule perforation and were observed in 2/341 patients (0.59%; 95%CI: 0.07-2.10%). They were treated using transcatheter arterial or venous embolization with a favorable outcome. The most frequent minor complications were abdominal pain (35/341; 10.26%; 95%CI: 7.25-13.99%) and supraventricular arrhythmia (15/341; 4.40%; 95%CI: 2.48-7.15%). No cases of inadvertent injury of the carotid artery were observed. Major complications during TJLB are extremely rare and can be managed using arterial or venous embolization with a favorable outcome. Our results reinforce the general assumption that TJLB is a safe and well-tolerated technique.

Clinical effect of double coaxial self-expandable metallic stent in management of malignant colon obstruction.

We aimed to evaluate the clinical effectiveness and safety of double coaxial self-expandable metallic stent (DCSEMS) in management of malignant colonic obstruction as a bridge to surgery or palliation for inoperable patients. Between April 2006 and December 2012, 49 patients (27 males and 22 females; median age, 68 years; age range, 38-91 years) were selected to receive decompressive therapy for malignant colonic obstruction by implanting a DCSEMS. Application of DCSEMS was attempted in 49 patients under fluoroscopic guidance. The obstruction was located in the transverse colon (n=2), descending colon (n=7), sigmoid colon (n=24), rectosigmoid junction (n=6), and the rectum (n=10). The intended use of DCSEMS was as a bridge to elective surgery in 23 patients and palliation in 26 patients. Clinical success, defined as >50% dilatation of the stent with subsequent symptomatic improvement, was achieved in 48 of 49 patients (98%). The stent was properly inserted in all patients. No immediate major procedure-related complications occurred. One patient in the bridge-to-surgery group had colon perforation three days after DCSEMS application. Four patients had late migrations of the double stent. Application of DCSEMS is safe and effective in management of malignant colonic obstruction; it prevents stent migration and tumor ingrowth and lowers perforation rate during the stent application.

Ethanol sclerotherapy of ovarian endometrioma: a safe and effective minimal invasive procedure. Preliminary results

ObjectiveTo study if ultrasound-guided aspiration with ethanol sclerosis is a safe and effective treatment for endometriomas. Study designWe conducted a prospective study of 25 women with 27 endometriomas (two bilateral) measuring 4–10cm in diameter with no suspected malignancy, who underwent ultrasound-guided aspiration and ethanol sclerosis between August 2010 and July 2014. Patients were followed up by ultrasound at 6, 12, 24, and 36 months to identify rates of complication and recurrence. Clinical characteristics of the patients (age, history of infertility, previous surgery, and abdominal pain), the cysts (location, diameter, and volume) and the procedure (duration and complications) were recorded. Kaplan–Meier survival curves were used to analyze the recurrence rates by SPSS statistical software. ResultsThe recurrence rate after sclerosis was 12%. The mean length of follow-up was 17 (SD 9.9) months. Although no major procedure-related complications were recorded, minor complications included three cases of low abdominal pain during the procedure (10.7%) and two cases of abdominal ethanol extravasation (7.1%). ConclusionUltrasound-guided aspiration and ethanol sclerotherapy are a safe and effective treatment for endometriomas measuring 4–10cm in diameter with no evidence of malignancy. This conservative treatment could possibly achieve a symptomatic cure while preserving healthy ovarian tissue, thereby improving fertility outcomes and avoiding early menopause.

Clinical Risk Factors Affecting Procedure-Related Major Neurological Complications in Unruptured Intracranial Aneurysms

PurposeThe operative risk and natural history rupture risk for the treatment of unruptured intracranial aneurysms (UIAs) should be evaluated. The purpose of this study was to report our experience with treating UIAs and to outline clinical risk factors associated with procedure-related major neurological complications.Materials and MethodsWe treated 1158 UIAs in 998 patients over the last 14 years. All patients underwent operation performed by a single microvascular surgeon and two interventionists at a single institution. Patient factors, aneurysm factors, and clinical outcomes were analyzed in relation to procedure-related complications.ResultsThe total complication rate was 22 (2.2%) out of 998 patients. Among them, complications developed in 14 (2.3%) out of 612 patients who underwent microsurgery and in 8 (2.1%) out of 386 patients who underwent endovascular procedures. One patient died due to intraoperative rupture during an endovascular procedure. The procedure-related complication was highly correlated with age (p=0.004), hypertension (p=0.002), and history of ischemic stroke (p<0.001) in univariate analysis. The multivariate analysis revealed previous history of ischemic stroke (p=0.001) to be strongly correlated with procedure-related complications.ConclusionA history of ischemic stroke was strongly correlated with procedure-related major neurological complications when treating UIAs. Accordingly, patients with UIAs who have a previous history of ischemic stroke might be at risk of procedure-related major neurological complications.

Long-Term Results of Combined Aortoiliac and Infrainguinal Arterial Reconstruction for the Treatment of Critical Limb Ischemia

This study was designed to investigate our long-term experience with combined iliac endovascular therapy (EVT) and infrainguinal bypass to treat critical limb ischemia (CLI) and compare outcomes to those of patients who underwent surgery for aortoiliac lesions. From April 2000 to June 2013, 57 patients (58 limbs) underwent an infrainguinal bypass combined with aortoiliac reconstruction to treat CLI. Eighteen limbs were treated by bypass alone and 8 limbs were treated by bypass with EVT for aortoiliac lesions (Bypass group). Thirty-two limbs were subjected to EVT alone for iliac lesions (EVT group). Preoperative limb ischemia was more severe in the EVT group. There were no significant differences in major procedure-related complications (χ(2) test, P = 0.853), systemic complications (P = 0.853), and mortality (P = 0.916) between the 2 groups. The limb salvage rates were 92% at 1, 3, and 5 years in the Bypass group and 93% at 1, 3, and 5 years in the EVT group, with no significant difference observed between the groups (Kaplan-Meier, log-rank test, P = 0.616). Infrainguinal surgical reconstruction combined with an iliac EVT is an acceptable strategy for managing patients with CLI.

0086: Non-contrast cardiac resynchronization therapy implantation is feasible in case of renal insufficiency

Renal insufficiency (RI) is frequent in patients eligible for cardiac resynchronization therapy (CRT) and may be worsened by the use of contrast agents. We sought to determine the feasibility of CRT implantation without contrast injection in patients with contraindication to iodine. Patients eligible for CRT and presenting with RI were prospectively included (non-contrast NC group). A contemporary control group (CG) of CRT patients with contrast injection was used for comparison. An over-the-wire coronary sinus (CS) lead with angled distal tip was selected for this “blind harpooning” technique. A lateral branch was targeted at first intention in a left anterior oblique fluoroscopic view. In case of failure, a contrast injection was then allowed if no lateral branch was found with the « blind » strategy. 9 patients in the NC group were included (78±8 y). Serum creatinine was 204±72[imol/L (clearance 34.2±17ml/min). CG included 10 patients (69,8±7 y, serum creatinine 98.7±23[imol/L). CRT implantation was successful in 8/9 patients (88.9%) without contrast injection. Patient 9 was finally implanted with CS opacification after failure of the NC technique. Mean procedure time and fluoroscopy time were similar in the two groups:146±26 in the NC group versus 157±25 min (p = 0.34) and 24.8±15 in the NC group versus 24.5±20 min (p = 0.96) respectively. Mean CS lead implantation time was 45±21 (NC group) versus 37±12 min (p = 0.24). No major procedure-related complications were observed in both groups. CRT implantation is feasible in the majority of the cases (88.9%) without contrast injection and without lengthening procedure time in patients with RI.

Transradial percutaneous coronary intervention for chronic total occlusion of coronary artery disease using sheathless standard guiding catheters

ObjectivesOur aim was to evaluate the feasibility and safety of routine transradial approach (TRA) percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) lesions using the sheathless technique with standard guiding catheters. BackgroundTransradial approach PCI was applied for CTO lesions. A major limitation of TRA CTO PCI is the inability to use large guiding catheters because of the relatively small size of the radial artery. Therefore, the sheathless technique for TRA PCI has been recently developed. However, reports on TRA CTO PCI using the sheathless technique are still lacking. MethodsSixty-eight patients with CTO lesions were enrolled for TRA PCI using the sheathless technique with standard guiding catheters. The baseline characteristics, coronary angiographic characteristics and major procedure or access site related complications were compared between procedure success and procedure failure group to determine the predictors of success in sheathless CTO PCI. In-hospital and 30-day clinical outcomes were also evaluated in this study. Routine assessments of radial artery occlusion via Doppler ultrasound and pulse oximeter were recorded during one-year clinical follow-up. ResultsThe mean duration of CTO by history was 31.8±42.3months. The 7 Fr standard guiding catheter was used with the sheathless technique in 91.2%, and bilateral sheathless approach in 42.6% of the study patients. The procedure-related complications included coronary perforation needing covered stent deployment (2.9%), cardiac tamponade (2.9%), collateral perforation needing coil deployment (4.4%), and contrast induced nephropathy (2.9%). Only 2 patients (2.9%) experienced forearm ecchymosis at the radial artery access sites. In-hospital mortality and 30-day all-cause mortality were 2.9%, and 30-day MACEs were 1.5%. The rate of radial artery occlusion during one-year clinical follow-up was only 3.0%. ConclusionsIt is feasible and safe to routinely use the sheathless technique with standard guiding catheters for TRA CTO PCI, with a low incidence of procedure-related complications and long-term radial artery occlusion.

Paclitaxel-Coated versus Plain Balloon Angioplasty for Dysfunctional Arteriovenous Fistulae: One-Year Results of a Prospective Randomized Controlled Trial

PurposeTo report 1-year results of a single-center randomized controlled trial comparing paclitaxel-coated balloon (PCB) versus high-pressure plain balloon angioplasty for the treatment of failing arteriovenous fistulae (AVFs). Materials and MethodsForty patients (26 men; mean age, 61 y ± 14.63) were randomized at 1:1 to undergo PCB (n = 20) or high-pressure balloon (HPB; n = 20) angioplasty of dysfunctional AVFs. There were no significant differences in baseline demographics between groups. Enrollment required a clinical diagnosis of a dysfunctional AVF attributed to a single stenotic lesion verified with digital subtraction angiography. Primary endpoints included device success, anatomic success, clinical success, and target lesion revascularization (TLR)–free survival. Secondary endpoints included dialysis circuit primary patency and procedure-related complication rates. ResultsDevice success rates were 100% in the HPB group and 35% in the PCB group (P < 0001): further dilation with an HPB was needed to achieve anatomic success in 13 of 20 cases in the PCB group (65%). Anatomic and clinical success rates were 100% in both groups. TLR-free survival (PCB, 308 d; HPB, 161 d; hazard ratio [HR], 0.478; 95% confidence interval [CI], 0.236–0.966; P = .03) and access circuit primary patency (PCB, 270 d; HPB, 161 d; HR, 0.479; 95% CI, 0.237–0.968; P = .04) were significantly in favor of PCB angioplasty. No minor or major procedure-related complications occurred. ConclusionsIn this single-center study, the use of PCBs resulted in superior TLR-free survival and dialysis access circuit primary patency of dysfunctional AVFs. However, additional HPB postdilation was required in the majority of cases.

Determining Factors in Diagnosing Pulmonary Sarcoidosis by Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

Although the role of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) in pulmonary sarcoidosis has previously been investigated, the determining factors in diagnosing sarcoidosis by EBUS-TBNA without rapid on-site evaluation (ROSE) are unclear. Patients with clinically and radiographically suspected sarcoidosis underwent EBUS-TBNA without ROSE in a prospective study. Presence of non-caseating epithelioid cell granulomas was pathologic evidence of sarcoidosis. The EBUS-TBNA was performed in 120 patients, 111 of whom had confirmed sarcoidosis. For the patients with sarcoidosis (62 stage I, 49 stage II) EBUS-TBNA provided sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 93.69%, 100%, 100%, 56.25%, and 94.17%, respectively, in the diagnosis of sarcoidosis. Diagnostic yield of EBUS-TBNA for sarcoidosis was associated with disease stage, but not associated with serum angiotensin converting enzyme level, number of lymph node stations sampled per patient, or total number of passes performed per patient. At EBUS-TBNA, 284 mediastinal and hilar lymph nodes were aspirated in 111 patients. Multivariate logistic regression revealed that short-axis diameter and more than 1 needle pass per lymph node were independent risk factors associated with positive pathology. No major procedure-related complications were observed. Endobronchial ultrasound-guided transbronchial needle aspiration is a safe procedure with high sensitivity for diagnosing sarcoidosis, having a higher diagnostic yield in stage I than stage II. To obtain a higher diagnostic yield of EBUS-TBNA in pulmonary sarcoidosis without ROSE, operators should select the largest mediastinal or hilar lymph node accessible and puncture with 3 to 5 passes.

Postpartum Hemorrhage from Extravasation or Pseudoaneurysm: Efficacy of Transcatheter Arterial Embolization Using N-Butyl Cyanoacrylate and Comparison with Gelatin Sponge Particle

PurposeTo evaluate the safety and effectiveness of transcatheter arterial embolization (TAE) using N-butyl cyanoacrylate (NBCA) for the treatment of active postpartum hemorrhage (PPH) and compare the efficacy of NBCA with gelatin sponge particles. Materials and MethodsFrom January 2004 to September 2013, 26 patients with PPH underwent TAE using NBCA as the primary embolic material. All patients were actively bleeding, and 12 (46.2%) had coagulopathy. TAE was performed using 1:2–1:4 mixtures of NBCA and ethiodized oil with or without use of a coil or gelatin sponge. To compare the efficacy of NBCA with conventional embolic material, 50 patients with active bleeding who underwent TAE using gelatin sponge were also analyzed. ResultsAngiograms demonstrated pseudoaneurysm or extravasation or both. The technical and clinical success rates were 100% and 92.3% (24 of 26 patients), respectively, for NBCA and 98% and 86.0% (43 of 50 patients), respectively, for gelatin sponge. In the NBCA group, one patient recovered with conservative management, and the other patient died because of multiorgan dysfunction. There were no major or minor procedure-related complications. ConclusionsTAE using NBCA as the primary embolic agent is an effective method for treating PPH with extravasation or pseudoaneurysm; NBCA is comparable to gelatin sponge particles. TAE using NBCA seems to fill pseudoaneurysms and make devascularization more effective than using gelatin sponge.