System For Closure Research Articles

Cardio-respiratory exercise testing early after the use of the Angio-Seal system for arterial puncture site closure after coronary angioplasty

The vascular closure device (VCD) Angio-Seal is an easy-to-use system for the closure of arterial puncture sites after percutaneous coronary intervention (PCI), and allows for early mobilisation of the patient. However, little data are available about exercising early after the use of VCD's in PCI patients. A total of 230 consecutive patients were screened. Of these, 45 (20%) were excluded due to the inability to perform exercise testing, or anatomical conditions which prevented the insertion of a VCD. The 185 remaining patients (139 male, mean age 68 ± 12 years) received Angio-Seal after PCI. After four hours, 30 patients (16%) showed a small local haematoma, 11 patients (6%) complained about minor -and one patient (0.5%) about strong- groin pain. There were no major bleeding complications, six pseudo-aneurysmata, and one arterio-venous fistula. Overall, nine patients (6%) showed moderate to severe groin problems. Patients without major complications underwent bicycle cardiopulmonary exercise testing the subsequent day. Exercise testing was performed up to 136 ± 60 W in 176 patients (94%). Maximum workload was 104 ± 33 W, peak oxygen consumption 17.6 ± 5.1 ml/min/kg, and oxygen consumption at the anaerobic threshold 15.4 ± 4.2 ml/min/kg. After exercise testing there were no cardiovascular complications noted. In patients receiving VCD after PCI, exercise testing above the anaerobic threshold was feasible after Angio-Seal deployment in those patients with no complications after the use of the device.

Premere occlusion system for transcatheter patent foramen ovale closure: Mid‐term results of a single‐center registry

Transcatheter closure of patent foramen ovale (PFO) with rigid devices may be problematic in patients with long channel PFO: alternative devices with asymmetrical opening and more physiological positioning may be preferable in such cases. We present the mid-term results of transcatheter closure of PFO with Premere Occlusion System, a device studied for this specific anatomy, in a single-center registry of adults with previous cerebral ischemia. During a 53-months period (July 1, 2005 to December 1, 2009) 70 patients (48 females and 22 males, mean age 38 ± 6.7 years) with previous stroke were admitted in our center for transcatheter closure of PFO with Premere Occlusion System on the basis of absence of moderate or severe atrial septal aneurysm (ASA) on Transesophageal echocardiography and intracardiac echocardiography (< 3RL or 3LR ASA and length of PFO channel >10 mm). The procedure was successful in all of the patients with no peri-operative and in-hospital complications. Forty-six 20 mm and twenty-four 25 mm Premere devices were implanted. Rates of procedural success, predischarge occlusion, and complication were: 100%, 95.7% and 0%, respectively. On mean follow-up of 40 ± 10.9 months (range 6-54), the follow-up occlusion rate was 98.5%. During follow-up, no cases of permanent atrial fibrillation, aortic/atrial erosion, device thrombosis, or atrioventricular valve inferences were noted. The mid-term outcomes of our registry suggests that the Premere Occlusion System may be an excellent device for patients with long-channel PFO and absence of moderate/severe ASA, offering a physiological and anatomically respective closure of PFO also in patients with hypertrophic rims.

Classification of proximal endovenous closure levels and treatment algorithm

Endovenous closure is a common method to treat saphenous vein incompetence. Despite attempts to prevent it, some patients have extension of thrombus above the ideal site of closure immediately below the epigastric vein. We have developed a classification system for the level of saphenous vein closure to guide further therapy after endovenous treatment. A six-tier classification system was developed, based on thrombus proximity to the epigastric or femoral vein, and an algorithm for treatment, based on level of closure was applied to all patients. Five hundred consecutive patients underwent radio-frequency ablation of the saphenous vein; it was successfully closed in 498 (99.6%) patients. Thirteen patients (2.6%) experienced thrombus bulging into the femoral vein or adherent to its wall, which was treated with anticoagulation. All of these patients had thrombus retraction to the level of the saphenofemoral junction (SFJ) in an average of 16 days with concurrent anticoagulation. No femoral deep venous thrombosis (DVT) occurred in the series. There was a significantly higher rate of proximal thrombus extension in those patients with a history of DVT and those with a great saphenous vein (GSV) diameter of >8 mm (P < .02). A classification system for saphenous endovenous closure which extends above the epigastric vein has been helpful in guiding management. A GSV diameter at the SFJ of >8 mm and a history of DVT results in significantly higher rates of proximal thrombus extension into the femoral vein. A short course of LMWH, until clot retracts back into the saphenous vein, is therapeutic. Management of the patients with thrombus flush with the femoral vein wall still needs to be defined, but the outcome from these patients is generally benign.

A new system for crack closure of cementitious materials using shrinkable polymers

This paper presents details of an original crack-closure system for cementitious materials using shrinkable polymer tendons. The system involves the incorporation of unbonded pre-oriented polymer tendons in cementitious beams. Crack closure is achieved by thermally activating the shrinkage mechanism of the restrained polymer tendons after the cement-based material has undergone initial curing. The feasibility of the system is demonstrated in a series of small scale experiments on pre-cracked prismatic mortar specimens. The results from these tests show that, upon activation, the polymer tendon completely closes the preformed macro-cracks and imparts a significant stress across the crack faces. The potential of the system to enhance the natural autogenous crack healing process and generally improve the durability of concrete structures is addressed.

New endoscopic over-the-scope clip system for closure of a chronic tracheoesophageal fistula

New endoscopic over-the-scope clip system for closure of a chronic tracheoesophageal fistula

Evaluation of a self-centering patch system for closure of muscular ventricular septal defects in a pig model

Objective: Closure of muscular ventricular septal defects (mVSDs) beyond the moderator band is still challenging. Recently, we established a new hybrid technique for closure of mVSDs on the beating heart. Here, we evaluated a self-centering patch system for this technique.

Cystic Duct Closure by Sealing With Bipolar Electrocoagulation

Cystic duct leakage after cholecystectomy is not uncommon and is a potentially serious complication. The aim of this study was to assess a bipolar sealing system (LigaSure) for closure of the cystic duct. The records from consecutive laparoscopic cholecystectomies performed in 2 hospitals with closure of the cystic duct with LigaSure after informed consent were recorded and complications and morbidity registered. The records were compared with those of patients undergoing laparoscopic cholecystectomy with closure of the cystic duct with clips during the same period. During the study period, 218 laparoscopic cholecystectomies were performed; 102 of these were performed with the LigaSure. One patient was excluded due to violation of the protocol. We experienced no cases of cystic duct leakage, but in one patient, bile leakage from the gallbladder bed was observed probably due to a small aberrant duct. The LigaSure system was safe and effective for closure and division of the cystic duct in laparoscopic cholecystectomy.

Novel over-the-scope-clip system for gastrotomy closure in natural orifice transluminal endoscopic surgery (NOTES): an ex vivo comparison study

Secure transluminal closure remains a fundamental barrier to clinical introduction of natural orifice transluminal endoscopic surgery (NOTES). Current NOTES closure modalities either do not provide secure closure or are too challenging to apply in vivo. The aims of this study were to evaluate gastric closure using the over-the-scope clip (OTSC) system in a previously described experimental setup, comparing the acute strength with a gold standard (hand surgical suturing). Comparison was done using an ex vivo porcine stomach experimental setup. The gastric opening was created by a needle knife puncture followed by dilation with 18-mm balloon. Control gastrotomies (n = 15; surgical suturing) showed a mean leak pressure of 206 mmHg (SD 59). A noninferiority design required a sample size of 11 specimens for the OTSC group. Closure comprised: (i) approximation of muscular layers using a flexible twin grasper; (ii) pulling the tissue into the OTSC cap at the tip of the scope; (iii) releasing the clip. Main outcome measures were leak pressure of closed gastrotomies, leak location, and time needed for adequate closure. Closure was successful in all specimens in a median of 3 minutes. Closed gastrotomies showed air leakage at mean pressure of 233 mmHg (SD 47), which was non-inferior compared with the predetermined gold standard (P = 0.003). Closure of gastric incisions to meet a predetermined leak pressure criterion was attainable and easy with the OTSC system. In vivo survival animal experiments are needed to further evaluate this promising closure modality.

Percutaneous Epicardial Left Atrial Appendage Closure: Preliminary Results of an Electrogram Guided Approach

Pharmacologic therapies to prevent stroke in atrial fibrillation (AF) have numerous limitations, prompting the development of device-based therapies. We investigated whether an electrogram-based approach using a novel hollow suture can safely capture and ligate the left atrial appendage (LAA). A novel system for closure of the LAA within the confines of the closed pericardium with a single sheath puncture was tested in 4 dogs. The tool used to grasp the appendage was fitted with electrodes and utilized electrical navigation to identify and confirm LAA capture. A hollow suture preloaded with a mechanical support wire to permit its manipulation and fluoroscopic visualization was advanced over the grasper, and the wire removed after the suture was positioned. The LAA was successfully closed in all dogs. In 2 dogs, after closure, a thoracotomy was performed and the LAA amputated without bleeding, confirming closure integrity. Necropsy confirmed closure in all animals. Using electrical navigation, percutaneous epicardial LAA ligation with a remotely tightened suture was performed successfully within the confines of the intact pericardial space. This technique may allow decreasing the risk of stroke in AF patients without the need for thoracotomy or an endocardially placed prosthetic device.

An over-the-scope clip (OTSC) system for closure of iatrogenic colon perforations: results of an experimental survival study in pigs

Perforation of the colon is a relatively rare complication of flexible endoscopy of the lower gastrointestinal tract. It has a reported incidence from between 0.2 % in diagnostic procedures to 0.5 % - 3 % in therapeutic procedures. Given the growing number of colonoscopies, the absolute number of iatrogenic perforations is not unimportant. The treatment of choice is most often surgical repair, since reliable and simple endoscopic techniques for perforation closure are currently unavailable. We aimed to evaluate our novel over-the-scope clip (OTSC) system for closure of iatrogenic perforations. We have developed a nitinol clip that will capture perforations of 10 - 15 mm, compressing the lesions until healing. The OTSC was studied in a prospective experimental trial in pigs (50 - 60 kg, n=10) for the closure of an iatrogenic perforation of approximately 5 --10 mm on the serosal side, that was created by repeated endoscopic biopsy. The follow-up period was 12 weeks. Follow-up colonoscopy was performed at 4 and 12 weeks. Successful, tight closure of the lesion with absence of peritonitis in the postoperative course was the primary endpoint of the study. Nine animals had an uneventful clinical course. At termination of the study, macroscopic and microscopic examination of the clipping sites in the bowel wall showed normal tissue healing. One animal died 1 day postoperatively for reasons unrelated to the procedure. In this experimental study the OTSC clip system was found to be a simple and secure closure method for iatrogenic colon perforations, and thus might be an alternative to surgical repair.

Endoscopic Treatment of the “Sump Syndrome” after Choledochoduodenostomy: A New Technique using an Amplatzer Septal Occluder

A 58-year-old male patient had been suffering for 35 years from recurrent cholangitis, biliary sludge and infection-induced stone formation after open cholecystectomy because of empyema of the gallbladder and severe acute and delayed postoperative complications. The pathophysiological origin of this chronic "sump syndrome" was a choledochoduodenostomy which had been performed prophylactically at the time of the initial operation. The patient agreed to an experimental treatment option with use of an Amplatzer atrial-septal defect (ASD) occluder for closure of the symptomatic choledochoduodenal fistula. The double-disc occluder was introduced through a 9 French diameter and 90 cm long sheath side to side with a duodenoscope. Under endoscopic and fluoroscopic guidance the distal disc was opened in the common bile duct, then retracted against the fistula's orifice. Subsequently, the proximal disc was unfolded in the duodenum, while the 9 mm waist between the two discs filled and shut the fistula. No side effects or complications were detected. The day after the procedure, endoscopic evaluation demonstrated the correct position of the occluder and closure of the fistula. Over a period of 12 months, repeated assessments did not reveal any major problems. The patient felt a significant subjective improvement. The use of a self-expanding occluder system for closure of a choledochoduoenotomy complicated by chronic and symptomatic duodenocholedochal reflux might therefore represent an enrichment of the equipment of interventional endoscopists.

An Improvised Wound Closure System

Skin stretching harnesses the same viscoelastic properties of the skin as expansion, with the difference that the forces are applied externally and not internally. An improvised system for wound closure is presented. The system is assembled using silicone vascular loops used as sutures and the flow controllers of intravenous sets as locking devices. The wounds are gradually closed by increasing the tension applied by the devices. The system has been applied to nine traumatic wounds in six patients. The average size of the wounds was 70 cm; the average number of devices used was 4.3 (range, 1-9; median, 3); the average time to achieve closure was 1.55 days (range, 0-2 days; median, 2 days). This system permits the closure of wounds not suitable for closure by primary intention and avoids the use of skin grafts or flaps.

Clinical application of vacuum pack system for temporary abdominal closure

To investigate the clinical application of a new temporary abdominal wound closure,vacuum system for temporary management of the open abdomen. Vacuum pack system consisted of polyethylene sheet,surgical towel,silicone drain, adhesive plastic drape. Clinical data of the patients undergoing exploratory celiotomy were recorded,and the indications for such temporary abdominal closure and its complications were reviewed. Thirteen trauma patients underwent such vacuum abdominal closure for 15 times, including 5 times (33.3%) for increased intra- abdominal pressure so that tension-free fascial closure was unable to achieve, 4 times (26.7%) for reexploration, 2 times (13.3%) for damage control, and 4 times (26.7%) for combined factors. Finally, seven patients (53.8%) received direct closure and 5 patients (38.5%) received skin grafting after granulation because the defect could not be closed directly. One patient (7.7%) died before abdominal closure was attempted. None of the patients developed enterocutaneous fistula and evisceration. Three patients (23.1%) developed intra-abdominal abscess. The vacuum pack is a better temporary abdominal wound closure device, and primary closure can be achieved in most of the patients. The technique is simple and easily mastered with a low complication rate.

Novel laser tissue-soldering technique for dural reconstruction

The goal of this study was to use a modified version of the CO2 laser-soldering system to develop a simple and reliable technique for the repair of dural defects after excision of brain tumors. The authors used a CO2 fiber optic laser system that they had developed for heating, monitoring, and controlling tissue temperature in situ and in real time, thereby reducing damage to the brain parenchyma. They adapted the system for dural closure by using free fascial grafts in a porcine model. Measures for estimation of reconstruction quality included visual assessment under magnification and direct measurements of adhesive strength and cerebrospinal fluid leak (CSF) pressure. Reliable soldering was achieved in 54 of 57 experiments, providing a 95% success rate. The average peak adhesive strength was 82 +/- 3 mN/cm2. The measured leak pressure of the fascia-dura mater bond was 66 +/- 5 mm Hg. Conventional suturing performed using Prolene stitches resulted in immediate CSF leakage from areas between the stitches and from the area of the needle hole itself. Fascia-dura mater soldering using the CO2 laser is feasible and may support CSF pressure up to six times higher than normal intracranial pressure. Findings of this study may provide a basis for the development of new tools for dural reconstruction.

′Sure closure′-skin stretching system, our clinical experience

ABSTRACT Objective: In clinical practice of reconstructive surgery one of the problems one routinely comes across is skin and soft tissue defects, which require coverage. Coverage of such wounds requires primary/secondary closure, skin grafting or flaps. The objective of our clinical series was to assess the efficacy of sure closure skin stretching system for closure of defects which otherwise would have required major flap cover or skin grafting. Methods: Our series included five patients with different causes and types of wound defects namely:1. Post-traumatic soft tissue defect on dorsum of hand.2. Post fasciotomy wound on leg (anterolateral aspect).3. Abdominal wound dehiscence following surgery for enterocutaneous fistula.4. Leg soft tissue defect following dehiscence of fasciocutaneous flap.5. Secondary defect following harvesting a lateral arm/forearm free flap.The device was applied to skin edges after preparing the wound under local anesthesia and the skin edges were brought together by turning the skin-stretching knob. After adequate approximation of the edges of the wound it was sutured by conventional suturing techniques.Results: All the wounds could be successfully closed using the skin stretching system in our series. The time taken for the closure ranged from 2 to 48 h. Conclusions: Sure closure skin stretching system is an effective device for closing some of the skin defects which otherwise would have required skin flaps or grafts. In all the patients wound closure could be achieved by this method and was carried out under local anesthesia. Use of this technique is simple and helps to reduce the morbidity and cost of treatment by allowing the reconstructive surgeon to avoid using major flaps or grafts.

′Sure closure′-skin stretching system, our clinical experience

Objective: In clinical practice of reconstructive surgery one of the problems one routinely comes across is skin and soft tissue defects, which require coverage. Coverage of such wounds requires primary/secondary closure, skin grafting or flaps. The objective of our clinical series was to assess the efficacy of sure closure skin stretching system for closure of defects which otherwise would have required major flap cover or skin grafting. Methods: Our series included five patients with different causes and types of wound defects namely: 1. Post-traumatic soft tissue defect on dorsum of hand. 2. Post fasciotomy wound on leg (anterolateral aspect). 3. Abdominal wound dehiscence following surgery for enterocutaneous fistula. 4. Leg soft tissue defect following dehiscence of fasciocutaneous flap. 5. Secondary defect following harvesting a lateral arm/forearm free flap. The device was applied to skin edges after preparing the wound under local anesthesia and the skin edges were brought together by turning the skin-stretching knob. After adequate approximation of the edges of the wound it was sutured by conventional suturing techniques. Results: All the wounds could be successfully closed using the skin stretching system in our series. The time taken for the closure ranged from 2 to 48 h. Conclusions: Sure closure skin stretching system is an effective device for closing some of the skin defects which otherwise would have required skin flaps or grafts. In all the patients wound closure could be achieved by this method and was carried out under local anesthesia. Use of this technique is simple and helps to reduce the morbidity and cost of treatment by allowing the reconstructive surgeon to avoid using major flaps or grafts.

A new technical approach for sternal closure with suture anchors (Dogan technique).

Various methods for sternal approximation have been described previously. Some patients undergoing these procedures are at risk for sternal dehiscence and mediastinitis. We used a different method, with a suture anchor system, for median sternotomy closure as an alternate technique in patients with a high risk of postoperative sternal dehiscence and sternal nonunion. Suture anchor systems have been developed principally for the fixation of tendons or ligaments to the bone. We first used the suture anchor system for median sternotomy closure, although it has been frequently used in various orthopedic surgical procedures. In this report, we describe the use, after fresh cadaveric tests, of an alternative technique in a patient undergoing coronary artery bypass grafting. There were no complications due to the suture anchor device, and successful application was performed for sternotomy fixation after surgical procedure in a patient. The standard techniques have several disadvantages, such as osteomyelitis, chondritis, cutting into the sternum and sternal dehiscence, prolonged hospitalization, and increased mortality and morbidity due to the listed complications, but these devices may protect the wire from cutting into the sternal bone. We propose suture anchors for reapproximation of the sternum to decrease the complications related to surgical steel wires. We therefore consider this technique to be easy, safe, and effective in patients with diabetes mellitus or severe osteoporosis considered to have risk for sternal dehiscence postoperatively. Another advantage of this suture system is that the titanium wire makes it more magnetic resonance compatible than systems using surgical steel wire.

Research Report: The Wadi el-Jarf Site: A Harbor of Khufu on the Red Sea

Wadi el-Jarf, located south of Zarafana, has parallels to two other Red Sea sites, Ain Sukhna (Ayn Soukhna) and Mersa/Wadi Gawasis. Over the course of two campaigns (2011-2012), an elaborate complex of storage galleries (some for storage of boat parts), including a system for closure, was excavated, as were camps, facilities for pottery production, dry-stone structures, and an L-shaped jetty with associated stone anchors. Inscriptional evidence allows for interpretation of the organization of the site and a date (reign of Khufu). Seemingly the earliest Egyptian harbor installation on the Red Sea, it may have been superceded by Ain Sukhna.

Congenital Heart Disease In Adults: A Historical Perspective

Congenital Heart Disease In Adults: A Historical Perspective

A new bipolar feedback-controlled sealing system for closure of the cystic duct and artery.

Bile leaks are serious complications after laparoscopic cholecystectomy. The aim of this study was to evaluate the feasibility of closure of the cystic duct with a new feedback-controlled bipolar sealing system (LigaSure). Ten domestic pigs underwent open cholecystectomy with the cystic duct and artery dissected and sealed with the new bipolar sealing system (LigaSure). Four and 8 days postoperatively, 5 pigs each were sacrificed and the closure of the cystic duct was evaluated. The cystic stump and the common bile duct were excised for histological examination. None of the pigs had a bile leak or a biliary peritonitis. There were no signs of postoperative bleeding or inflammation in Calot's triangle. Histology showed total necrosis of the cystic duct in the first two pigs due to too much energy used. The remaining specimens showed a regularly scaling zone without necrosis in 7 cases, and in one case a partial necrosis in the mucosa only was found. Cystic artery and cystic duct closure with the new device may be an alternative to the clip. Further trials should evaluate the feasibility and safety of the new device in the clinical setting.