Major Procedure-related Complications Research Articles

Laser-Assisted Removal of Embedded Vena Cava Filters: A 5-Year First-in-Human Study

Many patients are subjected to the potential risks and morbidity associated with an indwelling inferior vena cava (IVC) filter when standard methods fail to remove the filter. We evaluated the safety and effectiveness of the excimer laser sheath technique for removing embedded IVC filters. Over a 5-year period, 251 consecutive patients undergoing laser-assisted filter retrieval were prospectively enrolled. There were 103 men and 148 women (mean, 46 years; range, 15-82 years). Indications for retrieval included symptomatic acute IVC thrombosis, chronic IVC occlusion, and/or pain from filter penetration. Retrieval was also performed to prevent risks from prolonged implantation and potentially to eliminate the need for lifelong anticoagulation. After retrieval failed using three times the standard retrieval force (digitally measured), treatment escalation was attempted using a laser sheath powered by a 308-nm XeCl laser. Success was defined as complete filter detachment and removal from the body. Primary safety outcomes were major procedure-related complications. Laser-assisted retrieval was successful in 249 of 251 patients (99.2%) (95%CI, 97.2%-99.9%), with a mean implantation of 979days, range: 37-7,098days (> 19 years), among retrievable-type filters (n= 211) and permanent-type filters (n= 40). Average force during failed attempts without laser was 6.7 vs3.8 lbs during laser-assisted retrievals (P< .0001). The major complication rate was 1.6%(95%CI, 0.4%-4.0%), and all were successfully treated. Successful retrieval allowed cessation of anticoagulation in 45 of 46 patients (98%) (95%CI, 88%-99%) and alleviated filter-related morbidity in 55 of 57 patients (96%) (95%CI, 88%-99%). The excimer laser sheath technique is safe and effective for removing embedded IVC filters refractory to standard retrieval and high force. This technique can be used to alleviate or prevent filter-related morbidity and may allow cessation of filter-related anticoagulation. ClinicalTrials.gov; No.: NCT01158482; URL: www.clinicaltrials.gov.

First North American experience with the transfemoral ACURATE-neoTM self-expanding transcatheter aortic bioprosthesis.

Transcatheter aortic valve implantation (TAVI) has become a therapeutic alternative for patients presenting with severe symptomatic aortic stenosis and considered at high-surgical risk. Paravalvular leak (PVL), conduction disorders, and coronary obstruction remain unresolved procedure-related complications. The aim of this manuscript was to report the first North American experience with the ACURATE-neoTM aortic bioprosthesis and its ACURATE-TFTM delivery system (Symetis S.A., Ecublens, Switzerland). Transfemoral ACURATE-neoTM aortic valve implantation was performed in 20 patients. Clinical and echocardiographic assessment was performed at baseline, postprocedure and at least 30 days. Outcomes were assessed according to valvular academic research consortium (VARC-2) criteria. The mean age was 82.7 ± 7.0 years with a mean logistic-EuroSCORE-II of 5.0 ± 2.9% and Society of Thoracic Surgeons score of 4.7 ± 2.3%. Device success was achieved in all patients. The mean distance between the aortic-annulus and the left main coronary artery ostium was 14.3 ± 3.2 mm, and eight (40%) patients had <12 mm. At 30 days, there were no deaths, conversions to surgery, or major procedure-related complications. New-pacemaker implantation was required in one (5.3%) patient. ACURATE-neoTM implantation resulted in a significant reduction in mean transvalvular gradient (49.9 ± 15.8 to 9.7 ± 5.7 mm Hg, P < 0.0001) and increase in effective-orifice area (0.65 ± 0.16 to 1.83 ± 0.36 cm2 , P = 0.001) at hospital discharge. Paravalvular leak was absent in four (20%) patients, trace in nine (45%) patients, and mild in seven (35%) patients. Hospital discharge occurred at a mean of 7.0 ± 4.5 days, and all patients were in NYHA class I-II at a mean follow-up of 8.6 ± 2.3 months. The present initial North American experience shows that the ACURATE-neoTM aortic bioprosthesis was safely and successfully implanted by transfemoral approach. The special design of this newer-generation device affords a stable and predictable implantation, while providing optimal hemodynamic performance with a relatively low rate of PPI. © 2016 Wiley Periodicals, Inc.

Doxycycline poudrage: An old agent for a new technique

BackgroundPleurodesis is an, if not the most, important palliative option for management of symptomatic malignant pleural effusion (MPE). Asbestos-free calibrated talc is the most effective agent known for pleurodesis. Unfortunately, this agent is not available in many countries including Egypt. Doxycycline is an old agent used for pleurodesis. No data exists about doxycycline poudrage via thoracoscopy for pleurodesis in malignant pleural effusion. ObjectiveTo assess the efficacy, safety and outcome of medical thoracoscopic doxycycline poudrage in symptomatic MPE. MethodsThis is a prospective cohort clinical study. Thirty patients with symptomatic MPE were enrolled in March 2013 through March 2014. Medical thoracoscopic pleurodesis was done using oral forms of doxycycline. Patients were followed up for 90 days after the procedure. Efficacy was judged both clinically and radiologically. Procedure-related complications were recorded. ResultsPatients were 20 males and 10 females. Mean age±SD was 57.67±13.29years. The most common primary neoplasms were lung cancer and breast cancer (both, n=11). After 90days, 19 out of 22 surviving patients (86.4%, 95%CI=59.8–94.8%) had successful pleurodesis. No procedure-related major complications were recorded. Minor adverse effects included pain (28.6%), fever (25%) and wound infection (10.7%). Survival rate at 90dayswas 78.6%. Mean duration of hospitalization was 1.93±0.92days. ConclusionDoxycycline, as an old agent, when poudraged during medical thoracoscopy proved to be safe and effective agent for pleurodesis in symptomatic malignant pleural effusion.

Preoperative Epoxy Embolization Facilitates the Safe and Effective Resection of Venous Malformations in the Hand and Forearm.

The standard of care for treatment of low-flow venous malformations (VMs) is percutaneous sclerotherapy. These lesions are seldom surgically resected, especially if the malformation is in an anatomically difficult location. Percutaneous sclerotherapy is safe and effective. However, the drawbacks to sclerotherapy are the need for repeated treatments and risks of skin ulceration, deep venous thrombosis, scarring/contractures, and nerve damage. Surgical resection can be difficult because of intraoperative bleeding, intraoperative lesional decompression, and difficulty in localization. We describe our initial experience with 11 patients who underwent surgical resection of VMs located in the hand and forearm after preembolization of 27 total sites using n-butyl-cyanoacrylate or ethylene vinyl alcohol copolymer. Of the 11 patients treated, 5 had focal VMs, 3 had multifocal VMs, and 3 had diffuse VMs throughout the affected extremity. Four of the 5 patients with focal VMs were followed for at least 1 year, and no further treatment was required. All 3 of the patients with diffuse VMs have required ongoing treatment. No major functional impairments were reported, and there were no major procedure-related complications. Overall, embolization of the malformation before surgical resection facilitated localization, demarcation, and removal of the lesion.

Ultrasound-Assisted Catheter-Directed Thrombolysis: A Novel and Promising Endovascular Therapeutic Modality for Intermediate-Risk Pulmonary Embolism.

Intermediate-risk pulmonary embolism (PE), also known as submassive PE, occurs in a substantial group of patients and carries a significant mortality risk. With adequate risk stratification, catheter-directed techniques could be used as a therapeutic approach in the intermediate-risk PE. Ultrasound-assisted catheter-directed thrombolysis (UCDT) represents a novel endovascular technique with good clinical and safety outcomes. Ultrasound-assisted catheter-directed thrombolysis can achieve reduction in the thrombus burden and improvement of pulmonary hemodynamics and right ventricular (RV) dysfunction and/or dilatation, without major procedure-related complications, major bleeding, or hemorrhagic strokes. This narrative review will focus on the major studies involving the efficacy and safety of UCDT in the intermediate-risk PE population. Prospective, randomized clinical trials with long-term follow-up and a large sample size are needed for further evaluation of mortality benefit and to further define which subgroup of patients may benefit from this novel endovascular technique.

Left atrial appendage occlusion in high-risk patients with non-valvular atrial fibrillation

ObjectivePercutaneous left atrial appendage (LAA) occlusion has been developed as a viable option for stroke and thromboembolism prevention in patients with non-valvular atrial fibrillation (NVAF) and at high risk for...

Outcome of the Z-expandable metallic stent for Budd-Chiari syndrome and segmental obstruction of the inferior vena cava.

Treatment of segmental obstruction of the inferior vena cava (SOIVC) with Z-expandable metallic stents (Z-EMS) is controversial and data on long-term follow-up are lacking. We aimed to evaluate the long-term outcomes of the use of a Z-EMS for Budd-Chiari syndrome (BCS) patients with SOIVC. Between August 2004 and December 2014, 37 consecutive BCS patients with SOIVC were referred for Z-EMS treatment and subsequently underwent follow-up in our department. Data were collected retrospectively and follow-up observations were made 1, 2, 2-5, and 5-10 years postoperatively. Percutaneous transluminal balloon angioplasty and Z-EMS placement were technically successful in all patients. Major procedure-related complications occurred in four of 37 patients (10.81%). Follow-up for 61.89±41.45 months in 37 patients indicated portal hypertension in one patient 4 months after stent placement and symptoms were resolved by transjugular intrahepatic portosystemic stent shunting. Hepatocellular carcinoma was observed in four patients and five patients died during follow-up. Reocclusion of the inferior vena cava occurred in four patients (10.81%, 4/41) and all reocclusions were managed by percutaneous transluminal balloon angioplasty. Cumulative 1-, 2-, 2-5-, and 5-10-year primary patency rates were 94.60% (35/37), 93.33% (28/30), 88.89% (24/27), and 85.0% (17/20), respectively. Cumulative 1-, 2-, 2-5-, and 5-10-year secondary patency rates were 100% at all time-points. These data suggest that Z-EMS implantation is an efficacious, safe, and curative approach for BCS with SOIVC because satisfactory long-term outcomes were achieved. Long-term follow-up is required to ascertain stent patency and hepatocellular carcinoma occurrence.

Early Experience in the Management of Postoperative Lymphatic Leakage Using Lipiodol Lymphangiography and Adjunctive Glue Embolization

PurposeTo evaluate the safety and efficacy of Lipiodol lymphangiography and 3 adjunctive N-butyl cyanoacrylate (NBCA) glue embolization techniques for the management of postoperative lymphatic leakage. Materials and MethodsThis retrospective study included 27 patients with postoperative lymphatic leakage (17 with ascites, 3 with chylothorax, 6 with lymphoceles, and 1 with a skin fistula) who underwent Lipiodol lymphangiography for diagnostic and therapeutic purposes in 3 tertiary referral centers between August 2010 and January 2016. Adjunctive glue embolization was performed as needed by using 3 different techniques: “lymphopseudoaneurysm” embolization, closest upstream lymph node embolization, or direct upstream lymphatic vessel embolization. ResultsSixteen patients were observed to determine the therapeutic effect of lymphangiography, and 8 patients (50%) recovered without further embolization. In 16 patients, including 11 who underwent immediate embolization after lymphangiography and 5 who underwent delayed embolization, a total of 28 embolizations (12 lymphopseudoaneurysms, 14 lymph nodes, and 2 lymphatic vessels) were performed. The technical and clinical success rates of the adjunctive embolizations were 89% (25 of 28) and 94% (15 of 16), respectively. The overall clinical success rate was 85% (23 of 27). The median time from initial lymphangiography to recovery was 5 days. No procedure-related major complications were reported. ConclusionsLipiodol lymphangiography and adjunctive glue embolization techniques appear safe and provide promising efficacy for the management of postoperative lymphatic leakage.

Single-centre experience of extending indications for percutaneous intraportal islet autotransplantation (PIPIAT) after pancreatic surgery to prevent diabetes: feasibility, radiological aspects, complications and clinical outcome.

Islet allotransplantation is a less invasive alternative to surgical pancreas transplantation for Type 1 diabetes, while percutaneous intraportal islet autotransplantation (PIPIAT) is usually performed after pancreatic surgery to prevent diabetes. Our aim was to assess the feasibility, radiological aspects, complications and clinical outcome of PIPIAT following pancreatic surgery for not only chronic pancreatitis but also benign and malignant nodules. From 2008 to 2012, 41 patients were enrolled for PIPIAT 12-48 h after pancreatic surgery (extended pancreatic surgery for chronic pancreatitis and benign/malignant neoplasms). PIPIAT was performed using a combined ultrasonography and fluoroscopy-guided technique (4-F catheter). PIPIAT feasibility, median follow-up and metabolic (insulin independence rate, graft function based on C-peptide levels) and oncologic outcomes were recorded. PIPIAT was not performed in 7/41 patients (4 cases for an inadequate islet mass, 2 cases for haemodynamic instability and 1 case for islet culture contamination), while it was successfully performed in 34/34 patients. Procedure-related major complications occurred in four patients: two bleedings requiring transfusions, one patient with left portal vein thrombosis and one patient with sepsis. Median follow-up duration was 546 days. Insulin independence was achieved in 15/34 (44%) patients, partial graft function in 16/34 (47%) patients and no function in 3/34 (9%) patients. None of the 17 patients with malignant nodules developed liver metastases during follow-up. PIPIAT, performed under ultrasound and fluoroscopy combined guidance and not requiring immunosuppression, is feasible, with a relatively low complication rate and a better metabolic outcome than allotransplantation. PIPIAT can prevent pancreatogenic diabetes. Ultrasound is a useful tool for the guidance and monitoring of PIPIAT.

Charcoal suspension tattoo: new tool for the localization of malignant laterocervical lymph nodes.

We present a retrospective study to evaluate safety and effectiveness of ultrasound (US)-guided tattooing with charcoal of suspicious laterocervical lymph nodes. When an open biopsy of a laterocervical lymph node is needed, the choice of the lymph node to excise and examine is fundamental to avoid rebiopsy. Surgeons tend to choose the most surgical approachable enlarged lymph node that does not always correspond to the one with worst echographic aspect. We present 16 cases of patients with laterocervical adenopathy with inconclusive or non-adequate results at fine needle aspiration cytology addressed to open biopsy. Those patients underwent US-guided preoperative injection of a charcoal suspension inside the lymph node to excise to mark it, and then excisional biopsy was performed. Sixteen marked lesions (100%) were detected intraoperatively and dissected. The injected charcoal was detected intraoperatively in all cases. In 14 patients (87, 5%) it was inside the lesion; in two cases (12, 5%), the charcoal suspension was found in the tissues above the lesion. The procedure was well tolerated in all cases. No major procedure-related complications were encountered. US-guided charcoal tattooing is a new, safe, well-tolerated, and easy-to-perform technique for the marking of US suspicious laterocervical lymph nodes. This preliminary study shows a high technical success rate (76%) and high percentage of intraoperative detection of marked lesions (100%) with a low rate of complications.

Combination Therapies in the Management of Large (≥ 5 cm) Hepatocellular Carcinoma: Microwave Ablation Immediately Followed by Transarterial Chemoembolization

PurposeTo evaluate the safety and efficacy of microwave (MW) ablation combined with transarterial chemoembolization in a single stage for the treatment of large (≥ 5 cm) hepatocellular carcinoma (HCC). Materials and MethodsFrom March 2013 to January 2015, 66 patients (54 men and 12 women; mean age, 54 y; range, 29–83 y) with 72 large HCC lesions were included in this study. Eighteen (27.3%) had Barcelona Clinic Liver Cancer class B disease, and 48 (72.7%) had class C disease. Seventy-nine percent of patients (n = 52) had hepatitis B virus infection. The average tumor size was 9.0 cm ± 3.9, ranging from 5 to 19 cm. MW ablation was performed under ultrasound guidance, immediately followed by chemoembolization. Local tumor response, progression-free survival (PFS), and overall survival (OS) were assessed. ResultsThe technique was successfully performed in all patients. Complete response (CR) was achieved in 28 cases (42.4%), and partial response (PR) was achieved in 34 cases (51.5%) at 1 month after the procedure. The objective response rate (ie, CR plus PR) was 93.9%. Median PFS and OS times were 9 months and 21 months, respectively. The 6-, 12-, and 18-month OS rates were 93.9%, 85.3%, and 66.6%, respectively. Hemorrhage was detected in three patients and arteriovenous fistula in two patients after MW ablation; all were promptly treated with embolization. There were no liver abscesses, bile-duct injuries, or other major procedure-related complications. ConclusionsMW ablation immediately followed by chemoembolization is safe and effective in the treatment of large HCC lesions.

Systematic review of drug eluting balloon angioplasty for arteriovenous haemodialysis access stenosis.

Native or prosthetic arteriovenous (AV) fistulas are preferred for permanent haemodialysis (HD) access. These are marked with circuit steno-occlusive disease leading to dysfunction or even failure. Late failure rates have been reported as high as 50%. Standard angioplasty balloons are an established percutaneous intervention for HD access stenosis. Reported restenosis rates remain high and practice guidelines recommend a wide 6-month primary patency (PP) of at least 50% for any intervention. Neointimal hyperplasia is one of the main causes for access circuit stenosis. Drug eluting balloon (DeB) angioplasty has been proposed as an alternative intervention to reduce restenosis by local drug delivery and possible inhibition of this process. To systematically assess the reported efficacy and safety of DeB angioplasty in percutaneous management of prosthetic and autologous HD access stenosis. Protocol for the review was developed following the PRISMA-P 2015 statement. An electronic database (Medline, EMBASE, Clinical Trials.gov and Cochrane CENTRAL) search was conducted to identify articles reporting on the use of DeB intervention in HD AV access. Backward and forward citation search as well as grey literature search was performed. The MOOSE statement and PRISMA 2009 statement were followed for the reporting of results. Data from the included studies comparing DeBs with non-DeBs were pooled using a random effects meta-analysis model and reported separately on randomised and non-randomised studies. Six studies reported on 254 interventions in 162 participants (mean 27 ± 10 SD). The pooled mean and median duration of follow-up was 12 and 13 months (range 6-24 months). These comprised two randomised control trials (RCTs) and four cohort studies. Participant's mean age was 64 ± 5 years and 61% were male. Target lesions (TLs) ranged from under 2 mm to 5.9 mm and 51 were reported as de novo stenosis. Device failure described as wasting of the DeB was reported in two studies (55% and 92.8%). At 6 months TL PP was reported between 70% to 97% for DeBs in the RCTs and cohort studies, and 0% to 26% for non-DeBs. TLs treated with DeBs were associated with a higher primary patency at 6 months as compared to non-DeB balloons (RCTs: odds ratio [OR] 0.25, 95% CI 0.08 to 0.77 and I2 = 19%, cohort studies: OR 0.10, 95% CI 0.03 to 0.31 and an I2 = 20%). No procedure-related major or minor complications were reported. Current literature reports DeBs as being safe and may convey some benefit in terms of improved rate of restenosis when used to treat AV access disease. However, this body of evidence is small and clinically heterogeneous. A large multicentre RCT may help to clarify the role of DeBs in the percutaneous treatment of AV HD access stenosis.

A Leadless Intracardiac Transcatheter Pacing System

BackgroundA leadless intracardiac transcatheter pacing system has been designed to avoid the need for a pacemaker pocket and transvenous lead.MethodsIn a prospective multicenter study without controls, a transcatheter pacemaker was implanted in patients who had guideline-based indications for ventricular pacing. The analysis of the primary end points began when 300 patients reached 6 months of follow-up. The primary safety end point was freedom from system-related or procedure-related major complications. The primary efficacy end point was the percentage of patients with low and stable pacing capture thresholds at 6 months (≤2.0 V at a pulse width of 0.24 msec and an increase of ≤1.5 V from the time of implantation). The safety and efficacy end points were evaluated against performance goals (based on historical data) of 83% and 80%, respectively. We also performed a post hoc analysis in which the rates of major complications were compared with those in a control cohort of 2667 patients with transvenous pacemakers from six previously published studies.ResultsThe device was successfully implanted in 719 of 725 patients (99.2%). The Kaplan–Meier estimate of the rate of the primary safety end point was 96.0% (95% confidence interval [CI], 93.9 to 97.3; P<0.001 for the comparison with the safety performance goal of 83%); there were 28 major complications in 25 of 725 patients, and no dislodgements. The rate of the primary efficacy end point was 98.3% (95% CI, 96.1 to 99.5; P<0.001 for the comparison with the efficacy performance goal of 80%) among 292 of 297 patients with paired 6-month data. Although there were 28 major complications in 25 patients, patients with transcatheter pacemakers had significantly fewer major complications than did the control patients (hazard ratio, 0.49; 95% CI, 0.33 to 0.75; P=0.001).ConclusionsIn this historical comparison study, the transcatheter pacemaker met the prespecified safety and efficacy goals; it had a safety profile similar to that of a transvenous system while providing low and stable pacing thresholds. (Funded by Medtronic; Micra Transcatheter Pacing Study ClinicalTrials.gov number, NCT02004873.)

Embolisation for life-threatening haemoptysis complicated by systemic artery-pulmonary circulation shunts.

Tertiary referral centre. To retrospectively observe the characteristics of bronchial angiograms in the setting of systemic artery-pulmonary circulation shunts (SPS), and to evaluate the safety and effectiveness of bronchial artery embolisation (BAE) for these patients with life-threatening haemoptysis. The records of life-threatening haemoptysis patients with SPS who presented to a tertiary referral centre from January 2009 to March 2014 were reviewed. SPS consisted of bronchial artery-pulmonary artery shunt (AAS) in 30 cases, bronchial artery-pulmonary vein shunt (AVS) in 4 cases, non-bronchial systemic artery-pulmonary circulation shunt (n-BPS) in 7 cases and more than one type of SPS in 4 cases (AAS and AVS in 3 cases, three types of SPS in 1 case). BAE using polyvinyl alcohol (PVA) was successful in 97.8% (44/45) of the patients. Cumulative rates of freedom from recurrence at 1 month, 1 year and 2 years were respectively 97.8%, 93.2% and 85.4%. No major procedure-related complications occurred. No significant differences were found in recurrence rates or cumulative haemoptysis control rates among patients with different types of SPS complications (P = 0.55 and 0.46, respectively). BAE with PVA was safe and effective for life-threatening haemoptysis complicated by SPS.

Long Term Outcome in Patients with Esophageal Stenting for Cancer Esophagus - Our Experience at a Rural Hospital of Punjab, India.

Cancer of the esophagus is among the leading cause of cancer deaths in Punjab, India. Patients generally present with dysphagia as their first symptom and more often they have advanced disease at the time of presentation to a tertiary care centre. Palliative procedures have important roles in this setting. Stenting is the best option to palliate the symptoms of dysphagia, from which patient is suffering the most. To know the success rate, early and long term complications and mortality in esophageal stenting, when it was done in malignant esophageal stricture patients. One hundred patients, who had undergone esophageal stenting from January 2012 to January 2015, were included in the study. We retrospectively analysed the data for patient characteristics, causes of non-operability, early and long term complications, re-interventions, efficacy and mortality. Out of 100 patients, indications for stenting were locally advanced disease not amenable to surgery (52%), metastatic disease (35%), CVA (1%), cardiac and respiratory problem (8%), un-willing for surgery in 5% of patients. Majority of patients (94%) had squamous cell carcinoma, while only 6% had adenocarcinoma. 84% of patients presented with dysphagia with or without chest pain and recurrent cough while 16% had recurrent vomiting. 58% had dysphagia to liquids and solids and 17% had complete dysphagia. After stenting 93% had significant improvement in dysphagia score from median of 3 to 1. Post procedure stay was 3.61±1.0 days. One patient had procedure related major complication in the form of post procedural bleed (after 16 days of stenting) leading to death of that patient. Minor complications were present in 52 patients treated conservatively not affecting the efficacy of procedure. These include pain after stenting (38%), stent obstruction (23%) and stent migration (6%). All the minor complications were treated conservatively except in six patients in whom re-stenting was done. Esophageal stenting is relatively safe procedure with short stay of the patient in the hospital. Although, it helps in alleviating patients' morbidity very effectively and reliably, there are many technical glitches, which needs to be kept into account and patient should be properly counseled before the procedure to prevent and manage post procedure complications and medico legal aspects.

Long-term safety and outcome of percutaneous transhepatic venous balloon angioplasty for Budd-Chiari syndrome.

The restenosis following percutaneous transluminal balloon angioplasty (PTBA) is high for Budd-Chiari syndrome (BCS) patients with hepatic venous obstruction (HVO). We aim to evaluate the safety and long-term outcome of PTBA with a large balloon catheter in a large series of patients with HVO. Between January 2005 and December 2013, 93 consecutive BCS patients with HVO were referred for PTBA and subsequently underwent color Doppler ultrasonography or angiography follow-up. Data were retrospectively collected, and follow-up observations were performed at 1-, 2-, 2- to 5-, and 5- to 8-years postoperatively. Percutaneous transluminal balloon angioplasty was technically successful in all patients. Ninety-one patients (97.85%) were treated with PTBA and two with PTBA and stent. Major procedure-related complications occurred in six of the 93 patients (6.45%). The cumulative 1-, 2-, 2- to 5-, and 5- to 8-year primary patency rates were 97.5%, 92.9%, 90%, and 86.5%, respectively. Cumulative 1-, 2-, 2- to 5-, and 5- to 8-year secondary patency rates were 100%, 100%, 98.6%, and 97.3%, respectively. Mean and median primary patency rates were 51.50 ± 3.01 months and 55.0 ± 3.63 months, respectively. Cumulative 1-, 2-, 2- to 5-, and 5- to 8-year survival rates were 98.75%, 98.6%, 100%, and 100%, respectively. Mean and median survival times were 53.10 ± 3.04 months and 55.0 ± 3.64 months, respectively. Percutaneous transluminal balloon angioplasty with a large balloon is a safe and effective treatment that could provide excellent rates of long-term patency and survival for the majority of Chinese patients with BCS and HVO.

Predictors of positive angiography and evaluation of the outcome of transcatheter control of non variceal upper gastrointestinal hemorrhage

PurposeTo identify clinical factors influencing the positive angiographic findings identifying the bleeding source by angiography and to evaluation of the clinical outcome of embolization in angiography positive and in empiric embolization without identifying the bleeding source of upper gastrointestinal (UGI) bleeding. Materials and methodsTwenty-one patients were candidates for transcatheter angiography and embolization and followed up for 3–38months. ResultsTranscatheter angiography and embolization was technically and clinically successful in 95% and 86% respectively. Angiography identified the source in 11/20 and no source of bleeding seen in 9/20 in whom empiric embolization was carried out. Technical and clinical success or complications were not different. No procedure related major complications were encountered. Early and late mortalities were not different. Blood transfusion requirement and rate of hemoglobin drop were higher in positive compared to empiric group 9 vs 7U and 5.7 vs 6.5g/dL respectively (p=0.02), (p=0.1). Coagulopathy was found in 64% (n=7) in positive and in 38% (n=3) in empiric group (p=0.02). Recurrent UGI bleeding was noticed in patients with coagulopathy and were treated by coils alone. ConclusionTranscatheter angiography and embolization is safe and effective. Embolization can be done empirically even when angiographically negative is based on endoscopic localization of bleeding source.

Endovascular reconstruction of unruptured intradural vertebral artery dissecting aneurysms with the Pipeline embolization device

BackgroundDissecting aneurysms of the vertebral artery (VA) are difficult to treat using current surgical and endovascular techniques.ObjectiveTo analyze retrospectively the efficacy and safety of flow diverters in the treatment of...

FIRST NORTH AMERICAN EXPERIENCE WITH THE ENGAGER SELF-EXPANDING TRANSCATHETER AORTIC VALVE: INSIGHTS FROM THE LONDON HEALTH SCIENCE CENTRE HEART TEAM

BackgroundThe second-generation Engager valve consists of bovine pericardial leaflets mounted on a self-expandable frame. The device is specifically designed with anatomic orientation capabilities for accurate position and implantation by transapical access. The aim of this study was to report the initial North American experience with the Engager self-expanding transcatheter aortic valve implantation (TAVI).MethodsTransapical-TAVI with the Engager bioprosthesis was performed in a hybrid operating room under general anesthesia and transesophageal echocardiography guidance as complementary imaging tool. Clinical and echocardiographic data were prospectively gathered.ResultsA total of 4 patients (mean age of 80±6 years, logistic EuroSCORE of 19±8% and STS-score of 5±1%) were included. Reasons for refusing surgical aortic valve replacement where either previous coronary artery bypass grafting with adherent grafts, porcelain aorta, or age/frailty. The valve was anatomically oriented and successfully implanted in all patients. There were no conversions to surgery or major procedure-related complications. Engager implantation resulted in significant reduction of mean transvalvular gradient (50±18 mmHg to 15±6 mmHg, P=0.012). Pacemaker implantation was necessary in 1 patient. Hospital discharge occurred at a mean of 5±2 days and none of the patients showed paravalvular regurgitation at discharge echocardiogram.ConclusionTransapical Engager valve implantation was safe and effective for the treatment of elderly patients with aortic stenosis at high surgical risk. The anatomic orientation and anchoring within the native leaflets can avoid coronary obstruction, and allow optimal hemodynamic performance and avoidance of paravalvular regurgitation. BackgroundThe second-generation Engager valve consists of bovine pericardial leaflets mounted on a self-expandable frame. The device is specifically designed with anatomic orientation capabilities for accurate position and implantation by transapical access. The aim of this study was to report the initial North American experience with the Engager self-expanding transcatheter aortic valve implantation (TAVI). The second-generation Engager valve consists of bovine pericardial leaflets mounted on a self-expandable frame. The device is specifically designed with anatomic orientation capabilities for accurate position and implantation by transapical access. The aim of this study was to report the initial North American experience with the Engager self-expanding transcatheter aortic valve implantation (TAVI). MethodsTransapical-TAVI with the Engager bioprosthesis was performed in a hybrid operating room under general anesthesia and transesophageal echocardiography guidance as complementary imaging tool. Clinical and echocardiographic data were prospectively gathered. Transapical-TAVI with the Engager bioprosthesis was performed in a hybrid operating room under general anesthesia and transesophageal echocardiography guidance as complementary imaging tool. Clinical and echocardiographic data were prospectively gathered. ResultsA total of 4 patients (mean age of 80±6 years, logistic EuroSCORE of 19±8% and STS-score of 5±1%) were included. Reasons for refusing surgical aortic valve replacement where either previous coronary artery bypass grafting with adherent grafts, porcelain aorta, or age/frailty. The valve was anatomically oriented and successfully implanted in all patients. There were no conversions to surgery or major procedure-related complications. Engager implantation resulted in significant reduction of mean transvalvular gradient (50±18 mmHg to 15±6 mmHg, P=0.012). Pacemaker implantation was necessary in 1 patient. Hospital discharge occurred at a mean of 5±2 days and none of the patients showed paravalvular regurgitation at discharge echocardiogram. A total of 4 patients (mean age of 80±6 years, logistic EuroSCORE of 19±8% and STS-score of 5±1%) were included. Reasons for refusing surgical aortic valve replacement where either previous coronary artery bypass grafting with adherent grafts, porcelain aorta, or age/frailty. The valve was anatomically oriented and successfully implanted in all patients. There were no conversions to surgery or major procedure-related complications. Engager implantation resulted in significant reduction of mean transvalvular gradient (50±18 mmHg to 15±6 mmHg, P=0.012). Pacemaker implantation was necessary in 1 patient. Hospital discharge occurred at a mean of 5±2 days and none of the patients showed paravalvular regurgitation at discharge echocardiogram. ConclusionTransapical Engager valve implantation was safe and effective for the treatment of elderly patients with aortic stenosis at high surgical risk. The anatomic orientation and anchoring within the native leaflets can avoid coronary obstruction, and allow optimal hemodynamic performance and avoidance of paravalvular regurgitation. Transapical Engager valve implantation was safe and effective for the treatment of elderly patients with aortic stenosis at high surgical risk. The anatomic orientation and anchoring within the native leaflets can avoid coronary obstruction, and allow optimal hemodynamic performance and avoidance of paravalvular regurgitation.

Clinical Impact of Percutaneous Transhepatic Insertion of Metal Biliary Endoprostheses for Palliation of Jaundice and Facilitation of Chemotherapy

To describe the technique and report on the clinical benefit of percutaneous transhepatic metal biliary endoprosthesis (TMBE) placement for the palliation of malignant biliary obstruction (MBO). This is a retrospective single-center case series of 31 TMBE placements between October 2007 and October 2011 in 29 patients with inoperable MBO who failed endoscopic drainage and were not candidates for surgical resection. The mean age was 66.4 years. Eastern Cooperative Oncology Group performance scores were ≤2 in all patients. Data on procedural success, clinical and radiologic markers of stent patency, procedure-related complications, return to medically treatable status, benefit from chemotherapy, and survival were recorded. All TMBE procedures were successful with no major procedure-related complications, and all patients improved clinically. Mean preprocedural and postprocedural bilirubin concentrations were 228.9±138.4 and 39.9.0±33.6 μmol/L, respectively (P<0.0001). Mean overall survival and occlusion-free survival were 9.355±2.425 months (95% confidence interval [4.60-14.12]) and 4.678±0.720 months (95% confidence interval [3.27-6.09]), respectively. Chemotherapy was initiated or reinstated in 16 patients (55%), 7 of whom (44%) demonstrated stable disease or partial response. Three patients were lost to follow-up. TMBE provides acceptable palliation for patients with inoperable MBO who have failed endoscopic drainage. Stents appear to remain patent for the remainder of the patient's life in most cases and may facilitate the first induction or reinstatement of chemotherapy with further clinical response in some patients.