Endotherapy of leaks and fistula

Perforations, leaks and fistula involving gastrointestinal (GI) tract are increasing encountered in clinical practice. There is a changing paradigm for their management with surgical approach being replaced by conservative approach including endoscopic therapy. Clips (through the scope and over the scope) and covered stent are front runners for endotherapy for GI leaks and fistula. Over the scope clips introduced recently, can treat larger defects compared to through the scope clips. Covered stents are suited for larger defects and those associated with luminal narrowing. However cervical esophagus, gastro-esophageal junction, stomach and right colonic lesions may be better for clip therapy rather than stenting. Recent developments in this field include use of endovac therapy which consists of a sponge with suction device, biodegradable stent, use of fibrin glue and some endo-suturing device. Conservative therapy with no surgical or endoscopic intervention, may be suitable for a small subset of patients. An algorithm based on location, size of defect, associated stricture, infection and available expertise needs to be developed to reduce the mortality and morbidity of this difficult clinical problem.     

Endoscopic closure of a gastrocolic fistula using the over-the-scope-clip-system

Gastrointestinal (GI) defects such as fistulas and leaks can be potentially closed endoscopically using hemo-clips and loops. However, hemoclips may not allow for closure of large defects and they do not exert enough tensile force to keep fibrotic defects larger than 5 mm approximated. Herein we present a case of successful endoscopic closure of a gastrocolic fistula in a severely malnourished patient with complex post-surgical upper GI anatomy. We strongly believe that this device is a major breakthrough for the management of various types of discontinuity defects or fistulas. In addition, we show the usefulness of placing a direct jejunostomy using the double balloon enteroscopy (DBE) technique during the same procedure. The concept of providing direct jejunal feedings while allowing for upper gas-trointestinal bowel rest to promote the healing of the minimally invasive endoscopic operation is novel. Thus, our case is unique and exemplifies the utility of mini-mally invasive endoscopic endoluminal surgery.     

Novel treatment options for perforations of the upper gastrointestinal tract:Endoscopic vacuum therapy and over-the-scope clips

Endoscopic management of leakages and perforations of the upper gastrointestinal tract has gained great importance as it avoids the morbidity and mortality of surgical intervention.In the past years,covered selfexpanding metal stents were the mainstay of endoscopic therapy.However,two new techniques are now available that enlarge the possibilities of defect closure:endoscopic vacuum therapy(EVT),and over-the-scope clip(OTSC).EVT is performed by mounting a polyurethane sponge on a gastric tube and placing it into the leakage.Continuous suction is applied via the tube resulting in effective drainage of the cavity and the induction of wound healing,comparable to the application of vacuum therapy in cutaneous wounds.The system is changed every 3-5 d.The overall success rate of EVT in the literature ranges from 84%to 100%,with a mean of 90%;only few complications have been reported.OTSCs are loaded on a transparent cap which is mounted on the tip of a standard endoscope.By bringing the edges of the perforation into the cap,by suction or by dedicated devices,such as anchor or twin grasper,the OTSC can be placed to close the perforation.For acute endoscopy associated perforations,the mean success rate is 90%(range:70%-100%).For other types of perforations(postoperative,other chronic leaks and fistulas)success rates are somewhat lower(68%,and59%,respectively).Only few complications have been reported.Although first reports are promising,further studies are needed to define the exact role of EVT and OTSC in treatment algorithms of upper gastrointestinal perforations.     

How to do when PFO closure failed under routine guidance:the first clinical experience for PFO closure

Patent foramen ovale(PFO)is the most common abnormality of fetal origin and is affecting approximately 25%of the worldwide adult population.[1]During the past two decades,instead of surgical closure,catheter-based procedures to close the PFO have become widely used among patients.Periprocedural guidance with fluoroscopy,transesophageal echocardiography(TEE)or intracardiac echocardiography have been the mainstream technique to ensure a safe and successful procedure.     

The North American Immune Tolerance Registry: contributions to the thirty-year experience with immune tolerance therapy

Summary.  The North American Immune Tolerance Registry (NAITR) began in 1992 as a project of the ISTH Factor VIII/IX Subcommittee with the goal of further determining immune tolerance induction (ITI) practices in Canada and the United States. This retrospective registry study, published in 2002, was limited in its capacity to provide definitive answers to many unresolved ITI practice issues. Nonetheless, it played a role in developing guidelines for current ITI practice and in generating hypotheses that must now be examined through rigorous prospective data collection efforts. For haemophilia A, the logical next step has been the initiation of international prospective randomized studies of ITI outcome relative to factor VIII (FVIII) dose and purity for subjects with high titre inhibitors. Both trials will additionally provide platforms for translational study of the immunology of tolerance, a prelude to the next generation of safe and effective tolerizing strategies. For the less common problem of FIX inhibitor eradication, prospective randomized studies will not be a feasible way to confirm the NAITR observations. Coordinated international efforts will still be required to prospectively collect data on ITI outcome to document new potentially effective therapeutic strategies for inhibitor eradication. These registries will hopefully also serve to identify potential subjects for scientific studies of immunology of haemophilia B-related allergic phenomena, a devastating complication of FIX antibody development.     

Somatostatin analogues for the prevention of pancreatic fistula after open pancreatoduodenectomy: A nationwide analysis

BackgroundSomatostatin analogues (SA) are currently used to prevent postoperative pancreatic fistula (POPF) development. However, its use is controversial. This study investigated the effect of different SA protocols on the incidence of POPF after pancreatoduodenectomy in a nationwide population.MethodsAll patients undergoing elective open pancreatoduodenectomy were included from the Dutch Pancreatic Cancer Audit (2014–2017). Patients were divided into six groups: no SA, octreotide, lanreotide, pasireotide, octreotide only in high-risk (HR) patients and lanreotide only in HR patients. Primary endpoint was POPF grade B/C. The updated alternative Fistula Risk Score was used to compare POPF rates across various risk scenarios.Results1992 patients were included. Overall POPF rate was 13.1%. Lanreotide (10.0%), octreotide-HR (9.4%) and no protocol (12.7%) POPF rates were lower compared to the other protocols (varying from 15.1 to 19.1%, p = 0.001) in crude analysis. Sub-analysis in patients with HR of POPF showed a significantly lower rate of POPF when treated with lanreotide (10.0%) compared to no protocol, octreotide and pasireotide protocol (21.6–26.9%, p = 0.006). Octreotide-HR and lanreotide-HR protocol POPF rates were comparable to lanreotide protocol, however not significantly different from the other protocols. Multivariable regression analysis demonstrated lanreotide protocol to be positively associated with a low odds-ratio (OR) for POPF (OR 0.387, 95% CI 0.180–0.834, p = 0.015). In-hospital mortality rates were not affected.ConclusionUse of lanreotide in all patients undergoing pancreatoduodenectomy has a potential protective effect on POPF development. Protocols for HR patients only might be favorable too. However, future studies are warranted to confirm these findings.     

The North American experience with the Ablate and Pace Trial (APT) for medically refractory atrial fibrillation.

The Ablate and Pace Trial (APT) was a prospective registry study of clinical outcomes and survival following ablation and pacing therapy for medically refractory atrial fibrillation. One hundred and fifty-six patients were enrolled at 16 centres in North America. The mean patient age was 66 +/- 11 years, with mean left ventricular ejection fraction of 48% +/- 18%. Seventy-eight percent of the patients had structural heart disease. During one year of follow up, multiple measures of quality-of-life showed significant and sustained improvement following ablation and pacing therapy. Also, left ventricular ejection increased significantly for patients with baseline left ventricular ejection fraction <45%. Metabolic exercise testing showed trends toward improved exercise tolerance; however, these did not achieve statistical significance. The one year overall survival was 85%, with 3% of patients experiencing sudden death. In summary, this large, non-randomized, trial showed significant improvement in quality of life and left ventricular function following ablation and pacing therapy. Ablation and pacing therapy is a viable strategy for palliative management of patients with medically refractory, highly symptomatic atrial fibrillation.     

Percutaneous suture-mediated closure of femoral access sites deployed through the procedure sheath: initial clinical experience with a novel vascular closure device.

The objective of this study was to assess the initial safety and feasibility of a novel suture-mediated device for closure of femoral access sites immediately after diagnostic or interventional cardiac catheterization. In a prospective study, 150 patients (mean age, 61.5 years; 109 male) underwent femoral access closure with a novel suture closure device (Superstitch, Sutura) immediately after diagnostic (n = 106) or interventional (n = 44) catheterization procedures, independently of the coagulation status. All patients were monitored for 24 hr after the procedure. The closure device was successfully deployed in 92% of patients. Immediate hemostasis was achieved in 77% of patients with no differences between patients undergoing diagnostic catheterization or coronary interventions (79% vs. 73%; P = 0.659). After 2 min of additional light manual compression, hemostasis was achieved in 92% of patients. There was one major complication requiring vascular surgery (0.7%). The novel suture closure device is a safe and effective device that allows for immediate closure of femoral puncture sites after both diagnostic and interventional procedures with a low rate of major complications.     

A novel percutaneous technique for accessing the normal pericardium: a single-center successful experience of 53 porcine procedures

Recently, the pericardial space has been under consideration as an ideal site for prevention and treatment of coronary artery and heart disease. Historically, safe percutaneous entry has not been possible to sample or remove pericardial fluids for diagnostic purposes or to employ therapeutic agents in the absence of a sizable pericardial effusion. A non-surgical percutaneous approach to permit rapid access to the normal or minimally effused pericardial space holds high potential for considerable diagnostic and therapeutic utility. This study examines the utility of the PerDUCER pericardial access device, a simplistic approach to permit percutaneous access to the normal, minimal or diseased pericardial space, in a large series of animals (swine). The PerDUCER , inserted through the introducer sheath in a sub-xiphoid position, allowed capture and delivery of the intrapericardial guidewire into the pericardial space in all animals. The procedure was well tolerated by all animals and exhibited no signs of significant adverse hemodynamic effects. Twelve animals were sacrificed immediately after the experiment, while 41 animals were sacrificed 28 days after the procedure. Histologic examination showed no occurrence of epicardial vessel or myocardial damage. In addition, no late complications were found related to pericardial access with the PerDUCER . This initial experiment demonstrates that the PerDUCER provides an efficient, safe and effective technique to gain pericardial access in the normal or minimal pericardial space to obtain diagnostic sampling of the pericardial fluids and renders local intrapericardial delivery of therapeutic agents a possibility.