Clinical outcomes of MANTA vs suture-based vascular closure devices after transcatheter aortic valve replacement: An updated meta-analysis

Objective: A recently published randomized control trial showed different results with suture-based vascular closure device (VCD) than plug-based VCD in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). The learning curve for MANTA device is steep, while the learning curve for suture based VCD is shallow as the devices are quite different. In this meta-analysis, we have compared suture-based (ProGlide and Prostar XL) vs plug-based VCDs (MANTA). Methods: We performed a meta-analysis of all published studies (using PubMed/Medline and Cochrane databases) reporting the clinical outcome of plug-based vs suture-based VCDs in transfemoral TAVR patients. Results: We included nine studies with a total of 2865 patients (plug-based n ¼ 1631, suture-based n ¼ 1234). There was no significant difference in primary outcome of all bleeding when using plugbased as opposed to suture-based VCDs (RR 1.14 [0.62e2.06] I2 ¼ 72%). There was no significant difference in the incidence of secondary outcomes between two groups including major life threatening bleeding (RR 1.16 [0.38e3.58] I2 ¼ 65%), major vascular complications (RR 0.84 [0.35e2.00] I2 ¼ 55%), minor vascular complications (RR 1.05 [0.56e1.95] I2 ¼ 42%), pseudo aneurysm (RR 1.84 [0.11e29.98] I 2 ¼ 44%), stenosis-dissection (RR 0.98 [0.66e1.47] I2 ¼ 0%), VCD failure (RR 1.71 [0.96e3.04] I2 ¼ 0%), and blood transfusion (RR 1.01 [0.38e2.71], I2 ¼ 61%). Conclusion: Large bore arteriotomy closure with plug-based VCD was not superior to suture-based VCDs in this transfemoral TAVR population. There was very frequent use of secondary VCDs in suture-based VCD group which is not practical when using MANTA. Additional high-powered studies are required to determine the safety and efficacy of MANTA device.

Efficiency of Air Bubble Removal in Preparation of Low-Profile Angioplasty Balloon Catheter: Bench-Top Comparison of Six Methods / 신경중재치료의학

PURPOSE: Complete removal of air bubbles from balloons for neurovascular angioplasty is cumbersome. We compared the preparation difficulty, air removal efficiency, and air collection pattern of six different balloon catheter preparation methods to propose a better preparation method for both initial and second balloon uses, especially for small-profile angioplasty balloon catheters. MATERIALS AND METHODS: A total of 18 neurovascular angioplasty balloon catheters with nominal diameters of 2 mm were prepared to test six different preparation methods: the instruction for use method (method A), simplified method using a syringe (method B) and four newly devised preparation methods using inflating devices (methods C–F). Serial radiographs were obtained while the balloons were gradually inflated. We measured the time for each preparation and the bubble number, analyzed their distribution in the balloon, and calculated the contrast filling ratio (contrast filling area/total balloon area) for initial and second ballooning. The whole process was repeated three times. RESULTS: The preparation time varied widely (11.5 seconds [method D] to 73.3 seconds [method A]). On initial inflation, the contrast filling ratio at 8 atm was the highest (100%) with methods A and F. On second inflation, the ratio was again highest with method A (99.5%), followed by method F (99.2%). Initial ballooning tended to show a uniform pattern of single bubble in the distal segment of the balloon; in contrast, second ballooning showed varying patterns in which the bubbles were multiple and randomly distributed. CONCLUSION: None of the six methods were able to completely exclude air bubbles from the balloon catheters including the second ballooning; however, the method of repeating aspiration with high-volume inflating device (method F) could be a practical option considering the simplicity and efficiency of preparation.

The Incidence of Riata Defibrillator Lead Failure: a Single-Center Experience

Riata defibrillator leads were recalled due to a high failure rate. This study measured the incidence of externalized conductor (EC) and electrical dysfunction (ED) and sought to determine the predictors of ED with Riata defibrillator leads. We enrolled patients who received Riata® or Riata® ST silicone defibrillator leads at our center between January 2003 and December 2010. The presence of EC was evaluated with chest radiography. The incidence rates were measured at 5 years after lead implantation. We also investigated the rates of ED and other clinical events during the follow-up period. A total of 44 patients were analyzed. The total cumulative incidence of EC was 27.3%. During the median dwell time (80 months), the incidence of ED was 22.7%. Patients with ED were younger (46.5 vs. 56.5 years, P = 0.018) and had a higher prevalence of cardiomyopathy than those without ED (60.0% vs. 20.6%, P = 0.043). ECs were most frequently detected in patients who underwent X-ray analysis 3–5 years after lead implantation (44.4%). In contrast, ED had a bimodal incidence pattern, with peaks at 5 years (7.0%) and 9 years (5.3%). There was no difference in ED-free survival rate between patients with and without EC (P = 0.628). Given the delayed occurrence of EC and ED after implantation of Riata defibrillator leads, long-term close monitoring is critically important.

Large Steel Tank Fails and Rockets to Height of 30 meters - Rupture Disc Installed Incorrectly

At a brewery, the base plate-to-shell weld seam of a 90-m3 vertical cylindrical steel tank failed catastrophically. The 4 ton tank "took off" like a rocket leaving its contents behind, and landed on a van, crushing it. The top of the tank reached a height of 30 m. The internal overpressure responsible for the failure was an estimated 60 kPa. A rupture disc rated at < 50 kPa provided overpressure protection and thus prevented the tank from being covered by the European Pressure Equipment Directive. This safeguard failed and it was later discovered that the rupture disc had been installed upside down. The organizational root cause of this incident may be a fundamental lack of appreciation of the hazards of large volumes of low-pressure compressed air or gas. A contributing factor may be that the standard piping and instrumentation diagram (P&ID) symbol for a rupture disc may confuse and lead to incorrect installation. Compressed air systems are ubiquitous. The medium is not toxic or flammable. Such systems however, when operated at "slight overpressure" can store a great deal of energy and thus constitute a hazard that ought to be addressed by safety managers.

Successful Retrieval of a Fractured Guidewire during Extracorporeal Membrane Oxygenator Insertion / 대한내과학회지

Recently, the use of extracorporeal membrane oxygenation has evolved rapidly and there is potential for expanding its use. There are many complications associated with extracorporeal membrane oxygenation, but the fracture of a guidewire has been reported to be very rare during extracorporeal membrane oxygenation insertion. We describe our experience of successfully removing a fractured 0.038-inch guidewire using a catheter wedge with balloon inflation following a fracture that occurred during insertion of extracorporeal membrane oxygenation through the left femoral vein.

Implantable Cardioverter-Defibrillator Lead Extraction by Conventional Traction and Counter-Traction Technique

A 46-year-old man presented to our institution with inappropriate implantable cardioverter-defibrillator (ICD) shock delivery. The ICD (single chamber, dual shock coils) was implanted for sustained monomorphic ventricular tachycardia with unstable hemodynamics and underlying systolic left ventricular dysfunction. ICD interrogation revealed recurrent episodes of ICD shock due to noise sensing and increased impedance of right ventricular-lead. With the impression of lead fracture, ICD lead extraction was performed. The fractured ICD lead was completely removed by traction of locking stylet and counter-traction of polypropylene dilator sheath. A new lead was inserted and the patient was discharged without complications after 2 days. To our knowledge, this is the first report on ICD lead extraction by conventional traction and counter-traction technique in Korea.

Implantable Cardioverter-Defibrillator Lead Extraction by Conventional Traction and Counter-Traction Technique

A 46-year-old man presented to our institution with inappropriate implantable cardioverter-defibrillator (ICD) shock delivery. The ICD (single chamber, dual shock coils) was implanted for sustained monomorphic ventricular tachycardia with unstable hemodynamics and underlying systolic left ventricular dysfunction. ICD interrogation revealed recurrent episodes of ICD shock due to noise sensing and increased impedance of right ventricular (RV)-lead. With the impression of lead fracture, ICD lead extraction was performed. The fractured ICD lead was completely removed by traction of locking stylet and counter-traction of polypropylene dilator sheath. A new lead was inserted and the patient was discharged without complications after 2 days. To our knowledge, this is the first report on ICD lead extraction by conventional traction and counter-traction technique in Korea.

Clinical Outcomes of Cochlear Reimplantation Due to Device Failure

OBJECTIVES: The aim of this study was to evaluate the clinical features of cochlear reimplantation due to device failure. METHODS: The medical records of 30 patients who had undergone a revision cochlear implantation were retrospectively reviewed. Causes of revision operations, number of electrode channels inserted, and postoperative speech performances were analyzed. RESULTS: Device failure (N=12, 38.7%) and hematoma (N=3, 9.6%) were the two most common reasons for revision surgery. In patients with device failure, the number of electrode channels reinserted was equal to, or more than the number of channels inserted during initial implantation. Speech performance scores remained the same, or improved after reimplantation in patients with device failure. CONCLUSION: Device failure was the most common cause of revision operation in patients with cochlear implanttion. Contrary to expectation, new electrodes were fully inserted without difficulty in all reimplantation cases. Intracochlear damage due to reimplantation appeared to be clinically insignificant.

Clinical Outcomes of Cochlear Reimplantation Due to Device Failure

OBJECTIVES: The aim of this study was to evaluate the clinical features of cochlear reimplantation due to device failure. METHODS: The medical records of 30 patients who had undergone a revision cochlear implantation were retrospectively reviewed. Causes of revision operations, number of electrode channels inserted, and postoperative speech performances were analyzed. RESULTS: Device failure (N=12, 38.7%) and hematoma (N=3, 9.6%) were the two most common reasons for revision surgery. In patients with device failure, the number of electrode channels reinserted was equal to, or more than the number of channels inserted during initial implantation. Speech performance scores remained the same, or improved after reimplantation in patients with device failure. CONCLUSION: Device failure was the most common cause of revision operation in patients with cochlear implanttion. Contrary to expectation, new electrodes were fully inserted without difficulty in all reimplantation cases. Intracochlear damage due to reimplantation appeared to be clinically insignificant.

Magnet Displacement Following Cochlear Implantation / 대한이비인후과학회지

BACKGROUND AND OBJECTIVES: To describe a rare complication of cochlear implantation, such as magnet displacement which can be diagnosed easily with simple skull radiographs and treated with minimal surgery. MATERIALS AND METHOD: The record of male who experienced CI magnet dislodgement was reviewed. RESULTS: The patient was seen with a displaced magnet under the skin 15 days after a head trauma (1 month after implantation). The patient was implanted with the Nucleus 24 device at the age of 3 years. Plain skull radiographs showed the dislocated magnet. Surgery was limited to the revision of the receiver/stimulator site and reinsertion of the magnet to its pocket. Intraoperative neural response telemetry was normal in the patient. Postoperative auditory responses were as good as those measured before the complication. CONCLUSION: The displaced magnet can be successfully managed by a simple revision procedure. The possibility of magnet migration should be considered in cases of device malfunction.