Late Procedure-related Complications Research Articles

Use of EndoAnchors during index endovascular aortic aneurysm repair in patients with hostile proximal aortic neck anatomy.

Standard endovascular aortic aneurysm repair (EVAR) is sometimes the only treatment option for patients with hostile aortic neck anatomy, but it carries an increased risk of both early and late procedure-related complications. The aim of this study was to report on single-center experience with the Heli-FX EndoAnchors (Medtronic, Santa Rosa, CA) as an adjunctive procedure to endovascular aneurysm repair (EVAR) for prevention and perioperative treatment of proximal neck complications in patients with hostile neck anatomy. MATERIALS AND METHODS:Asingle-centre, retrospective study evaluating 24 consecutive patients treated with EndoAnchors during the index EVAR procedure between November 2018 and August 2021. EndoAnchor implantation was indicated for cases with hostile proximal aortic neck anatomy characterised by the presence of at least one of the following parameters: length of 28 mm, angle of >60°, circumferential thrombus/calcification involving ≥50%, and reverse taper. Median follow-up period was 22.5 months (IQR 2-31.5 months) with no aneurysm-related death, rupture, or conversion to open surgical repair during the follow-up. The procedural success rate was 100%, with no type Ia endoleak at the completion angiography. Amean of 7 EndoAnchors was used per patient (range 4-12). There were no EndoAnchor fractures and dislocations or stent graft fabric damage due to anchor implants.Twenty-three patients (95.8%) remained free of type Ia endoleak and migration on follow-up imaging. Aneurysm sac regression was observed in 13 patients (54.1%), while in 8 patients (33.3%) the sac remained stable. Sac enlargement was present in 1 patient (4.2%) due to late type Ia endoleak. Twopatients were lost to the follow-up immediately after the procedure.Between two groups of patients (sac regression versus failure to regress), the larger initial diameter of the proximal neck was the only significant independent factor associated with a lower possibility of sac regression (p= 0,021). The use of EndoAnchors during the index EVAR procedure in cases with challenging aortic neck anatomy with or without perioperative type Ia endoleak was associated with good midterm results and led to sac regression in most of the patients (Tab. 4, Fig. 3, Ref. 31).

B-PO05-114 SAFETY OUTCOMES OF SAME-DAY DISCHARGE FOLLOWING ABLATION FOR ATRIAL FIBRILLATION OR LEFT ATRIAL FLUTTER

Overnight monitoring after ablation of atrial fibrillation is the standard protocol. This approach stems from the concern for complications within 24 hours after the procedure. Advances in intra-cardiac echocardiogram, increased resolution of 3D electro-anatomical mapping, force-sensing catheters, and improved vascular access management have allowed for a significant decrease in cardiac perforation or groin hematomas. In addition to increased safety, the concerns related to hospital stays during COVID era signaled the need for same day discharge (SDD) consideration. Compare the safety outcomes and patient satisfaction on discharges the same day of procedure versus current standard of care. This study enrolled patients who underwent catheter ablation for atrial fibrillation or left atrial flutter from June 2020 to January 2021 at the University of Cincinnati Medical Center. SDD group was composed of patients who were free from complications for a minimum of 8 hours post procedure and discharged home the same day. The complications monitored during the 8-hours included hypotension with suspected tamponade, stroke, groin hematomas, or any abnormal rhythms noted on predischarge ECG. Standard of care was defined as those patients who remained in the hospital for 24-hours post procedure. Studied outcomes compared the procedure-related complications occurring within versus after the 8-hours post-procedure in the two groups. Additionally, an informal patient satisfaction survey was conducted between the two groups by collecting data from the next day phone follow-up and 1-month clinic visit. A total of 100 patients met inclusion criteria. Fifty-six (56%) patients were in the SDD group, whereas 44 (44%) received standard of care. Same-day discharge and standard of care patients had no significant difference in late procedure-related complications (less than 1% in both groups). Additionally, the SDD group displayed equivalent patient satisfaction as compared to the standard of care patients on follow-up phone call. Compared to the standard of care, same-day discharge provides equivalent patient safety and satisfaction. This has great implications for healthcare economics, especially in COVID-19 era.

Real life experience with atrial fibrillation cryoballoon ablation: results from a nationwide registry

Abstract Cryoballoon ablation (CBA) is an effective strategy for AF management. The Russian Cryoballoon Atrial Fibrillation Ablation Registry (NCT03040037) is a prospective observational multicenter national registry that aims to provide real-world efficacy, safety and outcomes of this technology. Purpose To evaluate the CBA efficacy, types of adverse events following CBA based on a multicenter nationwide registry. Materials and methods A web-based registry platform was developed for prospective data entry. The platform consisted of 8 sections: AF ablation experience, patient and CBA characteristics, periprocedural management, 12-month FU, redo procedures, early and late procedure-related complications. Inclusion criteria were the following: indications for AF catheter ablation, planned CBA, a signed informed consent. 32 ablation centers and 1118 patients (572 males, a mean age 68.3±11.4) were included into the registry. Paroxysmal AF was presented in 722 pts, persistent AF – 350 pts, long standing persistent AF – 46 pts. The main underlying diseases were hypertension, coronary artery disease, chronic heart failure; less commonly - hypertrophic cardiomyopathy and dilated cardiomyopathy. The mean LA diameter was 44.7±11.1 mm, LVEF was 62.6±10.8%. The mean BMI was 32.3±3.5 kg/m2. Cardioversion prior to CBA was performed in 32.8%. There were different strategies of AF recurrence documentation: ECG, 24-hour ECG monitor, ECG loop recorder implantation. Results The mean temperature of cryoablation was −45.7±17.4 C. The mean fluoroscopy time was 23.98 mins. The mean patient procedure duration was 108.46 mins [min 30; max 266]. The combination of RFA and CBA was reported in 9 cases. Periprocedural anticoagulant therapy included: uninterrupted NOACs (535 pts), bridge anticoagulation (365 pts), uninterrupted warfarin (67 pts), anticoagulation initiated only after CBA (151 pts). Transesophageal echo-guided CBA was performed in 126 cases, intracardiac echocardiography-guided CBA was performed in 474 cases. Esophageal temperature was controlled in 16 cases. A 12-months follow-up was completed in 906 pts (81.0%). Arrhythmia recurrence was documented in 238 cases (21.3%), mainly AF. Elective cardioversions were performed in 39 pts. Redo ablation procedures were performed in 122 cases. There were a wide range of antithrombotic therapy, as well as pts without anticoagulants despite the fact of AF recurrence. There were 35 (3.1%) CBA-related major adverse events. Esophageal damage was found in 3 cases. There were registered 3 deaths (1 – oncology, and 2 due to unknown cause), 1 MI, 3 persistent phrenic nerve dysfunctions, 3 valve dysfunctions. Conclusion This nationwide registry represents contemporary safety and efficacy of CBA for AF. A high success rate of the procedure has been shown during 12 months post procedure. Although a total low number of procedure-related complications has been noted, the occurrence of life-threatening adverse events calls for a caution. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): Government of the Russian Federation

P1422Low incidence of major procedure-related adverse events of cryoballoon ablation in real practice: an interim analysis of the Russian national prospective cryoablation registry

Abstract OnBehalf On Behalf Of the National Cryoballoon Registry Investigators Background Cryoballoon ablation (CBA) is an effective strategy for atrial fibrillation (AF) management. The Russian Cryoballoon Atrial Fibrillation Ablation Registry (NCT03040037) is a prospective observational multicenter national registry that aims to provide real-world efficacy, safety and outcomes of this technology. Methods A specialized Web-based registry platform was developed for prospective data entry. The platform consists of 8 sections: AF ablation clinic experience and operator experience, patient characteristics, CBA procedure characteristics, periprocedural patient management (including drug therapy), 12-moths follow-up with scheduled and unscheduled visits, redo procedure characteristics, early and late procedure-related complications. Patient inclusion criteria were the following: indications for AF catheter ablation, planned CBA, a signed informed consent. Results To date thirty-one clinics have joined the Registry, and 830 patients (477 males, a mean age 65.4 ± 11.3 years) were included. The mean BMI was 33.2 ± 3.3 kg/m2. Paroxysmal AF was presented in 688 pts, persistent AF – 111 pts, long standing persistent AF – 31 pts. The main underlying diseases were hypertension (75%), coronary artery disease (11%), chronic heart failure (25%); less commonly - hypertrophic cardiomyopathy (1.4%) and dilated cardiomyopathy (0.7%). The mean LA diameter was 45.4 ± 10.2 mm, and LVEF was 65.4 ± 12.6%. Periprocedural anticoagulant therapy included uninterrupted NOACs (313 pts), bridge anticoagulation (327 pts), uninterrupted warfarin (45 pts), anticoagulation initated only after CBA (32 pts). The mean temperature of cryoablation was -44.6 ± 16.3 C. Transesophageal echo-guided CBA was performed in 92 cases , intracardiac echocardiography-guided - in 465 cases. There were 5 (0.6%) cases of hemopericardium, and pericardiocentesis was required in 1 (0.1%) case only. Periprocedural TIA was diagnosed in 1 (0.1%) patient with bridge anticoagulation, no stroke occurred. Transient phrenic nerve injury was detected in 18 (2.1%) patients, persistent palsy – in 1 (0.1%) patient. Two cases of esophageal injury were reported, no surgery was required and healing was reported in both patients. The data collection is ongoing. Conclusion We report early results of the ongoing national CBA Registry. There was a low number of major procedure-related adverse events in real clinical practice among centers with different AF ablation experience. Long-term follow up of the included patients will be reported in the future. Abstract Figure. Antithrombotic therapy and CBA

2657 Novel Use of Radiofrequency Ablation in the Treatment of AVMs of Small Bowel Mucosa

INTRODUCTION: Radiofrequency ablation (RFA) is a well-authorized treatment in a number of gastrointestinal conditions such as dysplastic Barrett’s, gastric antral vascular ectasia and biliary stricture. We are presenting a case series focused on the use of RFA in the treatment of small bowel AVMs through small bowel enteroscopy, using a novel through the scope radio frequency ablation catheter. CASE DESCRIPTION/METHODS: Cases: This case series encompasses five cases using a new through the scope radio frequency ablation caterer to treat AVMs found in the small bowel and cecum. The age for these patients ranged from 56 to 72 years old, with two being males and three being females. Our patients presented for various reasons, including abdominal pain, abnormal CT findings, and gastrointestinal bleeding. Colonoscopies and endoscopies on these patients were unremarkable. All patients underwent single balloon enteroscopy, and multiple arteriovenous malformations (AVMs) were found. AVMs were successfully ablated using a novel through the scope radio frequency ablation catheter (RFA-SB). AVMs in these patients were found in the cecum, jejunum, ileum and stomach. 12 J/cm2 energy was applied with each paddle application. All patients recovered well after the procedure and follow up CBC showed improvement in their hematocrit. No immediate or late procedure related complications were reported. DISCUSSION: AVMs are one of the common causes of gastrointestinal bleeding. Ablation of AVMs in the small bowel has typically utilized argon plasma coagulation (APC) as a treatment modality. This case series looks at the use of a new RFA-SB as a new treatment modality for small bowel AVMs. This series is novel, due to the length of the new RFA catheter, as it is able to pass through a 200 cm small bowel enteroscope with better maneuverability and providing a uniform therapy than traditionally used APC technique without healthy tissue damage and achieving satisfactory hemostasis.

Retrospective study of immediate postoperative electron radiotherapy for therapy-resistant earlobe keloids

Keloid resection followed by adjuvant radiotherapy is the most efficacious treatment for keloids. However, for earlobe keloids, an optimal protocol for the total dose and fractions of adjuvant radiation has not yet been established. We retrospectively analyzed the efficacy and safety of immediate three-fraction electron radiotherapy after operation for resistant earlobe keloids. From 2011 to 2017, three-fraction electron radiotherapy with single dose of 5 Gy was given postoperatively to 23 patients with 30 keloids in our hospital. The first fraction of adjuvant radiotherapy was administered within 2 h of surgery, and the other two sessions were completed within the next day or two. Five (16.7%) primary keloids and 25 (83.3%) recurrent keloids were examined in this study. The primary endpoint was the local control rate, which was 86.7% after a median follow-up of 26 months (14–93 months). Secondary endpoints were acute and late procedure-related complications, and no severe complications were observed after combination therapy. Our results suggest that three-fraction electron radiotherapy after excision within 2 days of surgery is a safe and effective protocol for the prevention of earlobe keloid recurrence that can also improve patient compliance and comfort.

Randomized Controlled Trial of Aquablation versus Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia: One-year Outcomes

To report 1-year safety and efficacy outcomes after either Aquablation or transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia (BPH) METHODS: This double-blinded, multicenter prospective randomized controlled trial assigned 181 patients with BPH-related moderate-to-severe lower urinary tract symptoms to either electrocautery-based prostate resection (TURP) or Aquablation. Efficacy endpoints included reduction in International Prostate Symptom Score and improvement in uroflow parameters. The primary safety endpoint was the occurrence of Clavien-Dindo persistent grade 1 or grade 2 or higher complications. BPH symptom score improvements were similar across groups with 12-month reduction of 15.1 points after TURP or Aquablation. In both groups, mean maximum urinary flow rates increased markedly postoperatively, with mean improvements of 10.3 cc/s for Aquablation versus 10.6 cc/s for TURP (P = .8632). At 1 year, Prostate-specific antigen (PSA) was reduced significantly (P < .01) in both groups by 1 point; the reduction was similar across groups (P = .9125). Surgical retreatment for BPH rates for TURP were 1.5% and Aquablation 2.6% within 1 year from the study procedure (P = not significant (NS)). The rate of late complications was low, with no procedure-related adverse events after month 6. The 1-year outcomes after TURP and Aquablation were similar and the rate of late procedure-related complications was low. (ClinicalTrials.gov number, NCT02505919).

A Novel Technique for Endoscopic Ultrasound-guided Pancreaticogastrostomy: Duct Access Without Cautery Using Angioplasty Balloon

Introduction: Endoscopic ultrasound (EUS) - guided pancreaticogastrostomy (PG) has been used as an alternative to surgery and/or conventional endoscopic techniques to drain the pancreatic duct in cases of pancreatic duct strictures, stenotic pancreaticodigestive tract anastomosis (PD) and/or disconnected pancreatic duct syndrome (DPDS). Previous techniques employ use of needle-knife cautery, bougie dilation or a stent extraction screw to allow stent passage across the muscular gastric wall and pancreatic parenchyma. This can result in complications such as bleeding, perforation or acute pancreatitis. Moreover, passing standard balloon through pancreatic parenchyma into a small duct has a substantial risk of duct leak if the procedure fails. INTERVENTION:We present a novel technique employing EUS guided puncture and opacification of the PD with a 19-gauge (n=2) or a 22-gauge (n=3) needle, passage of 0.018 guidewire, creation of a trans-gastric fistula using a small shaft diameter (4 Fr) angioplasty balloon and subsequent ductal decompression with a plastic endoprosthesis (reverse insertion of a 3 Fr plastic pigtail stent over 0.018 wire with pigtail beginning to form in the duct to keep the stent in place). Methods: This is a retrospective study conducted at a single tertiary care center in Minneapolis, MN. An EUS-guided PG was offered to patients when conventional ERCP and/or EUS-guided rendezvous access to drain the pancreatic duct failed. A total of 5 patients were included in the study. Main outcomes that we report include technical success of the procedure and procedure related complications. Results: Indications for the duct drainage were DPDS (n=3) and stenotic PD anastomosis after Whipple procedure (n=2). Mean PD diameter was 4.3 mm (n=5). Technical success was achieved in 100% of the cases (5/5) and the angioplasty balloon passed easily over the guidewire without noticeable resistance in all cases. There were no immediate or late procedure related complications in our cohort of patients. Conclusion: EUS-guided PD decompression via creation of a transgastric fistula using a small shaft diameter angioplasty balloon and maintained via reverse placement of a small diameter pigtail plastic endoprothesis is a safe and technically simple alternative when conventional endoscopic techniques for PD access fail. Use of a small caliber angioplasty balloon provides easy access across the muscular gastric wall without the need for cautery, bougie or screw dilation.817_A Figure 1. Demographics, diagnostic findings and therapeutic first interventions in pancreatic duct drainage817_B Figure 2. Procedure related outcomes

Vertebral Augmentation

Vertebral compression fractures are a prevalent and growing public health problem associated with significant morbidity and economic cost. Most commonly, they occur in osteoporotic patients but are also seen in patients with metastatic cancer and secondary to trauma. Appropriate and timely treatment is imperative. When conservative treatments are inadequate, minimally invasive techniques, such as vertebroplasty and kyphoplasty, can provide substantial pain relief, improve function, and enhance quality of life. For appropriate patient selection, a comprehensive evaluation is essential to confirm the presence of concordant pain. Both vertebroplasty and kyphoplasty are performed percutaneously under radiographic guidance, and cement is injected into the collapsed vertebral body to provide strength and stability. Awareness of early and late procedure-related complications is necessary for perioperative planning. Overall, vertebral augmentation is a safe and efficacious procedure for patients suffering from pain related to vertebral compression fractures. This review contains 10 figures, 5 tables, and 74 references. Key words: adjacent level fractures, axial low back pain, cement injection, cement leakage, kyphoplasty, osteoporosis, parapedicular, polymethylmethacrylate, spinal metastasis, transpedicular, vertebral augmentation, vertebral compression fracture, vertebroplasty

CARDIAC RHYTHM DEVICE PROCEDURE RELATED COMPLICATIONS - TRACKING AND NEED FOR CONTINUOUS QUALITY IMPROVEMENT PROGRAMS

BACKGROUND: Patients with PMs or ICDs may be exposed to significant electromagnetic fields (EMF) from high voltage transmission lines (HVTL), which may interact with their device. To our knowledge, the rate of electromagnetic interference (EMI) has not been quantified nor have the circumstances of these EMIs. These were the objectives of the current registry. METHOD: Between February 2012 and March 2014, 18 296 device interrogations from patient visits to the PM/ICD clinic were reviewed (11 640 from PMs and 6 656 from ICDs). Fifty patients were recruited after noise episodes were seen during a routine follow-up interrogation. Only 10% of patients with noise episodes refused recruitment in the registry. Recruited patients were asked to keep a detailed log of their activities and travels. Their devices were then re-interrogated after 1, 4 and 12 weeks. Noise events registered on the devices interrogated in the PM/ICD clinic were correlated with a geographical map of the EMFs created by HVTLs, provided by Hydro-Quebec, the province of Quebec’s hydroelectric producer. RESULTS: Two patients were lost to follow-up. Of the remaining 48, 25 had further interference episodes for a total number of 1,080 episodes. Of these, 985 (91.2%) took place at home, 76 (7.1%), during an unknown activity (no activity recorded in the patient log at the time of the interference) and 19 (1.8%), during travels where a HVTL was identified in the vicinity. All of these travels, but one, were in motor vehicles which acted as a Faraday cage and shielded the patients and device from the electric field generated by the HVTLs. No episode was associated with a movement directly under a HVTL, on foot. There was no difference in the morphology of the noise signals based on the type of activity. A single inappropriate mode switch was noted as a result of the noise episodes. There was no relation between patient reported symptoms and the noise episodes. CONCLUSION: The overall rate of EMI is very low (0.3%) and the majority of episodes occur in the home environment. Despite the large number of patients sampled, there were no episodes of EMI linked to passage under a HVTL, which is reassuring from a public safety standpoint.

Su1565 EUS-Guided Choledochoduodenostomy or Hepaticogastrostomy to Malignant Distal Biliary Obstruction: a Prospective Comparative Trial

Su1565 EUS-Guided Choledochoduodenostomy or Hepaticogastrostomy to Malignant Distal Biliary Obstruction: a Prospective Comparative Trial Fernando Marson*, Paulo Sakai, Kiyoshi Hashiba, Everson L. Artifon Surgery Department, University of Sao Paulo Introduction: EUS-guided access to the bile duct is a novel technique that allows biliary drainage when standard ERCP is not feasible. When rendezvous procedure and/or anterograde interventions cannot be done as primary options, the alternative of creating a new fistula, a choledochoduodenostomy or hepaticogastrostomy can still be performed in selected patients. Aim: To compare the outcomes of two different drainage routes: choledochoduodenostomy and hepaticogastrostomy in selected patients that failed ERCP, rendezvous and anterograde intervention with distal malignant obstruction. Patients and Methods: Between April-2010 and July 2012 32 consecutive patients were elected to receive either a EUS-guided choledochoduodenostomy or EUS-guided hepaticogastrostomy. All patients had distal unresectable malignant biliary obstruction and had failed standard ERCP and EUS-guided rendezvous or anterograde intervention. Data including indications, success rate, technique, complications with a 3 month follow-up were prospectively collected in a database. All procedures were performed in a tertiary Endoscopic Unit. A partially covered SEMS (Boston Scientific, Wallflex,10 mm, 6 cm) was used in all procedures. After a EUS-guided bile duct puncture (choledochoduodenostomy) or a EUS-guided left hepatic duct puncture (hepaticogastrostomy) a cholangiogram was obtained followed by advancement of a 0,035 inch guide wire. Track dilation to allow passage of the stent delivery system was performed using a wire-guided needle-knife and bougies. Results: Thirty-two cases (15 hepaticojejunostomies and 17 choledochoduodenostomies) were performed. Indications for the procedure were pancreatic cancer (20 pts), extrinsic compression from metastasis (06) papillary tumor (02), neuroendocrine tumor (02), gallbladder cancer (01) and duodenal cancer (01). All patients were jaundiced and had both intra and extra-hepatic biliary dilation with elevated LFT‘s. Mean procedure time was 47 min. Three patients (2 choledochoduodenostomies and 1 hepaticojejunostomy) failed biliary drainage due to inability to advance the stent and were referred to surgery. Procedure success rate were similar in both groups: 93% for hepaticojejunostomy and 88% for choledochoduodenostomy. Immediate post-procedure complications occurred in 13% of the hepaticojejunostomy group (1 bleeding and 1 bacteremia) and 17% in the choledochoduodenostomy group (1 biloma, 1 bleeding and 1 stent migration). All immediate complications were successfully managed nonsurgically except the stent migration. No late procedure related complications were found in both groups during the follow-up time. Conclusion: Statistical analysis revealed no difference in the procedure time (p 0,24), success and complication rate (p 0,766) in this series. More studies are warranted to clarify the role of each drainage route.

Minilaparoscopic Varicocelectomy with Preservation of Testicular Artery and Lymphatic Vessels by Using Intracorporeal Knot‐tying Technique: Five‐year Experience

In this study we present our experience using minilaparoscopic intracorporeal knot tying to ligate internal spermatic veins (ISV) while sparing the spermatic artery and lymphatics. Minilaparoscopic varicocelectomies were performed in 87 patients between January 2004 and January 2009. All varicoceles were detected clinically according to the World Health Organization (WHO) classification and confirmed by scrotal color Doppler ultrasonography. The surgical indications were scrotal symptoms in 71, infertility in 16, and both conditions in 2. Three 3.5 mm minilaparoscopic ports were used for the operation. The ISVs were dissected and then ligated with intracorporeal knot-tying. The testicular artery and lymphatic vessels were carefully preserved to minimize procedure-related complications. Unilateral laparoscopic varicocelectomy was performed in 21 (24.2%) patients and bilateral in 66 (75.8%). Mean operative time was 71.1 ± 29.2 and 46.8 ± 12.6 min for bilateral and unilateral varicocelectomies, respectively. All patients were discharged within 24 h after surgery. Neither immediate major nor late procedure-related complications were noted. Of the 71 patients with scrotal symptoms, the symptoms completely subsided in 55 (77.5%) and partially subsided in 10 (14.1%). Only one (1.2%) recurrent varicocele was detected within a mean follow-up of 21 months (range = 3-42). Neither hydrocele formation nor testicular atrophy was found during the follow-up period. Our 5-year experience revealed that minilaparoscopic varicocelectomy with sparing of artery and lymphatic vessels could safely and effectively ligate all spermatic veins and preserve spermatic arteries and lymphatic channels without leading to a high varicocele persistence or recurrence.

Hybrid aortic reconstruction for treatment of recurrent aortic obstruction after stage 1 single ventricle palliation: Medium term outcomes and results of redilation

We describe a hybrid approach to the treatment of aortic obstruction after stage 1 palliation (S1P) of hypoplastic left heart syndrome. Recurrent aortic obstruction is a common problem after S1P of hypoplastic left heart syndrome. Even mild aortic obstruction is poorly tolerated so early and definitive therapy is desirable. Although stent implantation is an effective treatment for aortic obstruction in older children and adults, technical issues due to small vessels and concerns regarding future potential for expansion have generally precluded the use of stents in this setting. Six patients underwent hybrid aortic reconstruction (HAR) in the operating room or catheterization laboratory, with the interventional cardiologist and cardiac surgeon working in cooperation. Patients had a mean weight of 5.8 kg (2.9-7.7) and a mean age of 5.6 months (0.5-12.9) at the time of HAR. Five patients had undergone prior balloon angioplasty at a mean age of 2.8 months (2.1-3.5), and five had moderately depressed single ventricular function prior to HAR. The balloons used had a diameter of 7-10 mm and introducer sheath size ranged from 6 to 10 F. There were no immediate or late procedure related complications. Stent redilation was performed in 5 patients for relief of recurrent obstruction or to keep pace with somatic growth. At a median follow up of 4.8 years (0.2-7.9), there were 3 patients progressing well after Fontan palliation and 3 deaths. HAR allows for placement of stents that can ultimately reach adult size in small infants who have recurrent aortic obstruction after balloon angioplasty following S1P. Advantages include freedom from delivery sheath constraints when determining stent type/size, facilitation of precise stent position, and avoidance of vascular damage or hemodynamic compromise during the procedure. Longer follow-up and larger experience are required to determine if this therapy will provide a long-term solution to this difficult problem.

Clinical experience with a novel subcutaneous implantable defibrillator system in a single center

BackgroundImplantable cardioverter-defibrillators (ICDs) reduce mortality in both primary and secondary prevention, but are associated with substantial short- and long-term morbidity. A totally subcutaneous ICD (S-ICD) system has been developed. We report the initial clinical experience of the first 31 patients implanted at our hospital.MethodsAll patients had an ICD indication according to the ACC/AHA/ESC guidelines. The first 11 patients were part of the reported CE trial. The implantation was performed without fluoroscopy. The device was implanted subcutaneously in the anterior axillary line, with a parasternal lead tunneled from the xiphoid to the manubrial–sternal junction. Ventricular fibrillation (VF) was induced to assess detection accuracy and defibrillation efficacy using 65 J shocks.ResultsPost-implant, 52 sustained episodes of VF were induced. Sensitivity was 100% and induced conversion efficacy was 100% (with standard polarity in 29 patients). Mean time to therapy was 13.9 ± 2.5 s (range 11–21.6 s). Late procedure-related complications were observed in 2 of the first 11 implantations (lead migration). During follow-up, spontaneous ventricular arrhythmias occurred in four patients, with accurate detection of all episodes. Inappropriate therapy was observed in five patients. Recurrences were prevented with reprogramming.ConclusionsThe S-ICD system can be implanted without the use of fluoroscopy by using anatomical landmarks only. Episodes of VF were accurately detected using subcutaneous signals, and all induced and clinical episodes were successfully converted. The S-ICD system is a viable alternative to conventional ICD systems for selected patients.

Acompanhamento clínico de pacientes portadores de cardioversor-desfibrilador implantável

To report appropriate (AT) and inappropriate (IT) ICD therapies in patients with ischemic and nonischemic heart disease, as well as early and late procedure-related complications. One hundred and fifty-five patients (119 male and 36 female), mean age 47 years (21-88), who underwent ICD implantation between 1994 and March 2003 were analyzed. Patients were divided into the following groups: Group I--Post-AMI patients (n = 80); Group II--Patients with nonischemic heart disease and LV ejection fraction < 40% (n = 45), Chagas disease (n = 18), idiopathic dilated cardiomyopathy (n= 12), hypertensive disease (n = 8), hypertrophic cardiomyopathy (n = 4) and valvular heart disease (n = 3); Group III--Patients with arrhythmogenic right ventricular dysplasia (n = 13); and Group IV--Patients with channelopathies: Brugada Syndrome (n = 8) and idiopathic ventricular arrhythmias (n = 9). All patients underwent electrophysiological study (EPS) with induction of sustained ventricular arrhythmia ICD implantation. During the 26-month mean follow up, a high rate of appropriate ICD therapies (antitachycardia pacing and/or shock) was observed (46%) in the four groups, with no statistically significant difference. The four groups did not differ in either overall (8.4%) or arrhythmic mortality (1.3%). There was no correlation between appropriate ICD therapies and initial clinical presentation or inducible ventricular arrhythmia at EPS, and a 4% incidence of early and late procedure-related complications was found. The high incidence of appropriate ICD therapy and low rate of sudden death in the patients studied suggest that ICD is a valuable strategy in the management of ischemic and nonischemic patients previously selected by means of EPS.

Palliation of inoperable esophageal tumor with endoscopic intubation

Access to expensive equipment and costly self-expanding metal endoprostheses is limited in some regions where unresectable esophageal cancer is not infrequent. The aim of this study was to review the long-term results of palliation of malignant esophageal obstruction using low-priced conventional plastic stents. 103 patients with dysphagia due to inoperable esophageal cancer underwent esophageal intubation under endoscopic control alone, without general anesthesia, by the pulsion method. Stents mounted on their delivery device were inserted over an endoscopically placed guide wire. Improvement in swallowing was seen in 100%. Dysphagia scores have improved from 3.64+/-0.21 to 1.08+/-0.17. Major early procedure-related morbidity was low (0.6%), with 1 intramural perforation and no transmural perforation at all. Minimal mucosal bleeding was seen with 48 cases (46.6%). Procedure-related mortality was 0%. Late procedure-related complications requiring further endoscopic procedures occurred in 13.5% (tube occlusion: 8.7%, tube dislocation: 4.8%). Our 7 day mortality was 0% and 5 patients had died within 30 days, usually from the disease itself. Those surviving the procedure (>7 days) had a mean survival of 209 days. Esophageal plastic stents can be accurately and safely placed under direct endoscopic control with lower costs. Therefore, endoscopic intubation remains a useful palliative treatment for patients with unresectable carcinoma of the esophagus.

Donor Lymphocyte Infusion: The Use of Alloreactive and Tumor-Reactive Lymphocytes for Immunotherapy of Malignant and Nonmalignant Diseases in Conjunction with Allogeneic Stem Cell Transplantation

Donor lymphocyte infusion (DLI), pioneered in Jerusalem in January 1987, represents the first proof of principle of the absolute efficacy of immunotherapy as a means of curing cancer. Immunotherapy with alloreactive donor lymphocytes can eliminate "the last tumor cell" even in patients with hematological malignancies resistant to maximally tolerated doses of chemoradiotherapy. Alloreactive lymphocytes that can mediate anti-tumor effects following induction of host-versus-graft tolerance induced by transplantation of donor stem cells, can induce graft-versus-malignancy (GVM) effects which are usually accompanied by graft-versus-host disease (GVHD). However, occasionally GVM effects may also be accomplished independently of clinically overt GVHD. Interestingly, allogeneic donor lymphocytes may also eliminate undesirable host-derived hematopoietic cells in a large number of nonmalignant indications including genetic diseases, diseases caused by deficiency of stem cell products, and autoimmune disorders mediated by self-reactive lymphocytes. The cumulative clinical experience suggests feasibility of effective induction of graft-versus-leukemia (GVL); graft-versus-lymphoma (GVLy); graft-versus-multiple myeloma, as well as graft-versus-solid tumors (GVT), well-documented in patients with renal and breast cancer, even in patients with resistant disease that have failed myeloablative chemoradiotherapy. These observations that suggested that cell therapy by donor lymphocytes is the main therapeutic benefit of bone marrow transplantation (BMT) led to development of the nonmyeloablative approach for safer allogeneic stem cell transplantation. Nonmyeloablative stem cell transplantation (NST) makes it possible to offer an option for cure to elderly patients with no upper age limit, as well as to patients with poor performance status not considered eligible for conventional BMT. Using well-tolerated NST regimen, allogeneic stem cell transplantation can be accomplished with minimal procedure-related toxicity and mortality, possibly even on an outpatient basis. Immunotherapy mediated by adoptive allogeneic cell-mediated immunotherapy can be further improved by utilizing specifically immune donor lymphocytes, thus maximizing their efficacy against undesirable target cells of host origin on the one hand, while minimizing their ontoward efficacy against normal cells of host origin that could result in GVHD on the other. Taken together, DLI and subsequently NST, may have opened new horizons for treatment of life-threatening malignant and nonmalignant disorders correctable by allogeneic stem cell transplantation. It is anticipated that further improvement of reactivity and specificity of donor lymphocytes will lead to safer clinical application of cell therapy for a larger number of indications toward improving disease-free survival in a large number of indications while minimizing immediate and late procedure-related complications.

Endoscopic palliation of oesophageal carcinoma with Atkinson prosthesis

To assess the degree of palliation, the associated morbidity and mortality and to compare our results with other published series, we reviewed our use of the Atkinson prosthesis in 100 consecutive patients for the palliation of unresectable oesophageal carcinoma. The group had a mean age of 71.2 +/- 2.3 years. All prostheses were placed by the pulsion method. Intubation was successful in 91%. Improvement in swallowing was seen in 82.1%. Major early procedure-related morbidity was high at 23% with 11 perforations (11%). Procedure-related mortality was 12%. Those aged 70 years or more had a 34.5% risk of morbidity and 15.5% risk of dying from the procedure. Late procedure-related complications requiring further endoscopic procedures occurred in 27%. Our 7 day mortality was 14.7% (14 patients) and 31 patients (32.6%) had died within 30 days, usually from the disease itself. Those surviving the procedure (> 7 days) had a mean survival of 105 (range 9-735) days. We obtained acceptable palliation but with a significant morbidity and mortality. Endoscopic intubation remains a useful palliative treatment for patients with unresectable carcinoma of the oesophagus and cardia.