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Transvenous lead extraction (TLE) has evolved as one of the most crucial treatment options for patients with cardiac device-related systemic infection (CDRSI).The aim of this study was to characterize the procedural outcome and risk factors of patients with CDRSI undergoing TLE.A subgroup analysis of patients with CDRSI of the GALLERY (GermAn Laser Lead Extraction RegistrY) database was performed. Predictors for complications, procedural failure, and all-cause mortality were evaluated.A total of 722 patients (28.6%) in the GALLERY had "systemic infection" as extraction indication. Patients with CDRSI were older (70.1 ± 12.2 years vs 67.3 ± 14.3 years; P.001) and had more comorbidities than patients with local infections or noninfectious extraction indications. There were no differences in complete procedural success (90.6% vs 91.7%; P = .328) or major complications (2.5% vs 1.9%; P = .416) but increased procedure-related (1.4% vs 0.3%; P = .003) and all-cause in-hospital mortality (11.1% vs 0.6%; P.001) for patients with CDRSI. Multivariate analyses revealed lead age ≥10 years as a predictor for procedural complications (odds ratio [OR] 3.23; 95% confidence interval [CI] 1.58-6.60; P = .001). Lead age ≥10 years (OR 2.57; 95% CI 1.03-6.46; P = .04) was also a predictor for procedural failure. We identified left ventricular ejection fraction30% (OR 1.70; 95% CI 1.00-2.99; P = .049), age ≥75 years (OR 2.1; 95% CI 1.27-3.48; P = .004), chronic kidney disease (OR 1.92; 95% CI 1.17-3.14; P = .01), and overall procedural complications (OR 5.15; 95% CI 2.44-10.84; P.001) as predictors for all-cause mortality.Patients with CDRSI undergoing TLE demonstrate an increased rate of all-cause in-hospital, as well as procedure-related mortality, despite having comparable procedural success rates. Given these data, it seems paramount to develop preventive strategies to detect and treat CDRSI in its earliest stages.

Background: The incidence of cardiac implantable electronic device (CIED)-related complications, as well as the prevalence of obesity, is rising worldwide. Transvenous laser lead extraction (LLE) has grown into a crucial therapeutic option for patients with CIED-related complications but the impact of obesity on LLE is not well understood. Methods and Results: All patients (n = 2524) from the GermAn Laser Lead Extraction RegistrY (GALLERY) were stratified into five groups according to their body mass index (BMI

Aims The subcutaneous cardioverter-defibrillator (S-ICD) may be a valuable option in patients after successful transvenous lead extraction (TLE) without indication for pacemaker therapy and persistent risk of sudden cardiac death. The aim of this study was to evaluate device performance, postoperative outcome, and safety in patients who received a S-ICD after TLE compared to patients who underwent de-novo S-ICD implantation. Methods A retrospective analysis of all patients included into our institution's S-ICD database between September 2010 and May 2019 was conducted.The patients were divided in two groups, depending on whether they had received their S-ICD after TLE (n = 31) or de-novo (n = 113). Results The TLE group was significantly older with a mean age of 54.3 ± 15.7 versus 46.7 ± 14.4 years; p = .007. Leading S-ICD indication in the TLE group was previous infection (50%), whereas in the de-novo group the S-ICD was primarily chosen due to young patient age (74.6%). Median duration of follow-up was 527.0 versus 472.5 days, respectively; p = .576. Most common complication during follow-up was inappropriate ICD therapy (12.9% vs. 13.3%); p = 1.000. Pocket erosion/infection occurred in 3.2% versus 3.5% with no reported cases of systemic (re-)infection in either group; p = 1.000. All-cause mortality was low (6.2% vs. 2.7%) and entirely unrelated to S-ICD implantation or the device itself; p = .293. Conclusion The S-ICD is a safe and effective alternative for patients after TLE with very similar results regarding device performance and postoperative outcome, when compared to patients who underwent de-novo S-ICD implantation.

Aims The GermAn Laser Lead Extraction RegistrY: GALLERY is a retrospective, national multicentre registry, investigating the safety and efficacy of laser lead extraction procedures in Germany. Methods and results Twenty-four German centres that are performing laser lead extraction have participated in the registry. All patients, treated with a laser lead extraction procedure between January 2013 and March 2017, were consecutively enrolled. Safety and efficacy of laser lead extraction were investigated. A total number of 2524 consecutive patients with 6117 leads were included into the registry. 5499 leads with a median lead dwell time of 96 (62–141) months were treated. The mean number of treated leads per patient was 2.18 ± 1.02. The clinical procedural success rate was 97.86% and the complete lead removal was observed in 94.85%. Additional extraction tools were used in 6.65% of cases. The rate of procedural failure was 2.14% with lead age ≥10 years being its only predictor. The overall complication rate was 4.32%, including 2.06% major and 2.26% minor complications. Procedure-related mortality was 0.55%. Female sex and the presence of abandoned leads were predictors for procedure-related complications. The all-cause in-hospital mortality was 3.56% with systemic infection being the strongest predictor, followed by age ≥75 years and chronic kidney disease. Conclusion In the GALLERY, a high success- and low procedure-related complication rates have been demonstrated. In multivariate analysis, female sex and the presence of abandoned leads were predictors for procedure-related complications, while the presence of systemic infection, age ≥75 years, and chronic kidney disease were independent predictors for all-cause mortality.

Background The number of patients requiring lead extraction has been increasing in recent years. Despite significant advances in operator experience and technique, unexpected complications may occur. Prophylactic placement of femoral sheaths allows for immediate endovascular access for emergency procedures and may shorten response time in the event of complications. Objective The purpose of this study was to assess the benefits of routine prophylactic femoral access in patients undergoing transvenous lead extraction (TLE) and to evaluate the methods, frequency, and efficacy of the emergency measures used in those patients. Methods We conducted a retrospective analysis of patients who underwent TLE from January 2012 to February 2019. The data were analyzed with regard to procedural complications and deployment of emergency measures via femoral access. Results Two hundred eighty-five patients (mean age 65.3 ± 15.5 years) were included in the study. Median lead dwell time was 84 months (interquartile range 58–144). Overall complication rate was 4.2% (n = 12), with 1.8% major complications (n = 5). Clinical success rate was 97.2%. Procedure-related mortality was 1.1% (n = 3). Femoral sheaths were actively engaged in 9.1% (n = 26) of cases. Deployment of snares was the most common intervention (n = 10), followed by prophylactic (n = 6) or emergency placement (n = 1) of occlusion balloons, temporary pacing (n = 3), venous angioplasty (n = 3), diagnostic venography (n = 3), and extracorporeal membrane oxygenation (n = 1). We did not observe any femoral vascular complications due to prophylactic sheath placement. Conclusion Routine prophylactic placement of femoral sheaths shortens response time and quickly establishes control in the event of various complications that may occur during TLE procedures.

Background Eosinophilic myocarditis (EM) is a rare form of myocarditis. Clinical presentation is various, includes cardiogenic shock and can often be fatal. Diagnosis is based on myocardial eosinophilic infiltration in endomyocardial biopsy. Mechanical circulatory support (MCS) is often required in patients suffering from severe cardiogenic shock. Among the available MCS options the “ECMELLA” concept, a combination of left ventricular venting by Impella® device and extracorporeal life support (ECLS) is possibly able to provide the necessary time frame for diagnostics and initiation of anti-inflammatory medication in patients with fulminant myocarditis. Case presentation We report a case of a 38‐year‐old woman who was presented to us in severe cardiogenic shock, quickly requiring hemodynamic support by an Impella CP® device. Further dramatic hemodynamic deterioration accompanied by multi-organ dysfunction required escalation of MCS via ECLS as veno‐arterial extracorporeal membrane oxygenation (VA-ECMO). After histopathological diagnosis of EM, our patient was put on immunosuppressive therapy with prednisolone. Recovery of both right and left ventricular function allowed explanation of VA-ECMO on day 4 and further hemodynamic improvement allowed removal of the Impella® device on day 9. The patient was discharged after 7 weeks with fully restored cardiac function and in a good neurological state. Conclusions In severe cardiac shock due to fulminant EM the ECMELLA concept as bridge-to-recovery seems to be a valid option to provide the required time for diagnostics and specific therapy.

OnBehalf GALLERY investigators Background The number of cardiac implantable electronic device (CIED)-associated complications such as infection, lead dysfunction or thrombotic events is continuously rising and thus making transvenous lead extraction (TLE) an ever more needed procedure in clinical practice today. Patients with abandoned leads represent a special cohort with a potentially higher susceptibility to CIED-related infections and vascular complications. Moreover, according to literature abandoned leads seem to be associated with more procedural complications and mortality during TLE. Aim The aim of this study was to provide an insight on safety, procedural outcome and risk prediction on pacemaker patients with abandoned leads undergoing TLE from the largest national laser-sheath registry to date. Methods + Results: We conducted a retrospective analysis of the GALLERY database, which collected 2533 patients undergoing TLE in Germany between 2013 and 2017. Out of 903 pacemaker patients, who underwent TLE, 226 patients (25.0%) with abandoned leads were identified. Those patients had a higher number of leads per patient (3.2 ± 0.8 vs. 1.9 ± 0.3; ns) and longer lead dwell-times (168.0 ± 89.7 vs. 123.0 ± 69.2 months; p < 0.0001) compared to pacemaker patients without abandoned leads. There were no differences in age (71.5 vs. 72.3 years; ns), body mass index (26.5 ± 4.5 vs. 26.78 ± 4.8 kg/m2; ns) or gender distribution (69.0 vs. 66.5% male; ns). Leading indication for TLE was device infection with no difference between groups (79.7 vs 77.8 %; ns). There were no differences in terms of pacemaker dependency, length of hospitalization or comorbidities. Patients with abandoned leads had longer procedure times (112.0 ± 69.0 vs. 86.4 ± 53.0 minutes; p < 0.0001) and a higher incidence of procedural complications (6.6 vs. 3.1%; p = 0.03), but there were no differences in neither procedural and clinical success rates (96.5 vs. 97.3%; ns), nor all-cause mortality (1.33 vs. 2.66%; ns). Multivariate logistic regression revealed abandoned leads (OR 2.1, CI 1.0-4.4, p = 0.04) and female gender (OR 2.4, CI 1.2-4.9, p = 0.02) as independent predictors for procedural complications. Systemic infection (OR 5.4, CI 2.0-14.8, p = 0.001) and chronic kidney disease (OR 4.0, CI 1.5-10.7, p = 0.007) were strong predictors for all-cause mortality in patients with indwelling pacemaker. Patient age > 75 years (OR 3.9, CI 2.7-5.6, p < 0.0001) and a lead dwell-time > 10 years (OR 1.6, CI 1.1-2.2, p = 0.01) were identified as risk factors for an infectious cause for TLE. Conclusion Abandoned leads are frequently encountered in pacemaker patients undergoing TLE and pose an important risk factor for procedural complications. Systemic CIED-related infections are the strongest driver of mortality in this patient cohort and urgently call for further improvements in early diagnosis and prevention.

Anorexia nervosa is a potentially life-threatening eating disorder, characterized by an abnormally low body weight. This case report illustrates a 22-year old female with cardiac arrest due to a refeeding syndrome in a patient with anorexia nervosa. It features the successful use of extracorporeal cardiopulmonary resuscitation in a case of severe left ventricular dysfunction resulting in a favorable outcome.Conclusion. We present the first case of a cardiac arrest due to a refeeding syndrome in anorexia nervosa featuring the successful use of an extracorporeal cardiopulmonary resuscitation approach as a bridge to full recovery.

BACKGROUND Many patients awaiting heart transplantation (HTX) have a cardiac implantable electronic device (CIED). Lead removal is often still a part of the HTX procedure. Abandoned lead fragments carry a risk for infections and prohibit magnetic resonance imaging (MRI) imaging. This study evaluated the concept of an elective lead management algorithm after HTX. METHODS AND RESULTS Between 2009 and 2018, 102 consecutive patients with previously implanted CIED underwent HTX. Lead removal by manual traction during HTX was performed in 74 patients until December 2014. Afterward, treatment strategy was changed and 28 patients received elective lead extraction procedures in a hybrid operating room (OR) using specialized extraction tools. Total of 74 patients with 157 leads underwent lead extraction by manual traction during HTX. The mean lead age was 32.3 ± 38.7 months. Postoperative X-ray revealed abandoned intravascular lead fragments in 31(41.9%) patients, resulting in a complete lead extraction rate of only 58.1%. The high rate of unsuccessful lead extractions led to the change in the extraction strategy in 2015. Since then, HTX was performed in 28 CIED patients. In those patients, 64 leads with a mean lead age of 53.8 ± 42.8 months were treated in an elective lead extraction procedure. No major or minor complications occurred during lead extraction. All leads could be removed completely, resulting in a procedural success rate of 100%. CONCLUSION Our results demonstrate that chronically implanted leads should be removed in an elective procedure, using appropriate extraction tools. This enables complete lead extraction, which reduces the infection risk in this patient population with the necessity for permanent immunosuppressive therapy and allows further MRI surveillance.

Introduction Comparative data of early recurrence rates of atrial fibrillation (ERAF) following second-generation cryoballoon (CB-G2) and radiofrequency current (RFC) ablation for pulmonary vein isolation (PVI) in paroxysmal AF (PAF) are rare. We randomized PAF patients into either PVI with CB-G2 (group 1) or PVI with a combined RFC-approach applying contact force (CF) with the endpoint of unexcitability (group 2) to investigate ERAF. Methods In group 1 ( n = 30), CB-G2-PVI was performed. After CF-PVI in group 2 ( n = 30), bipolar pacing on the ablation line and additional ablation until unexcitability was conducted. Follow-up included 48 h of in-hospital monitoring followed by 5-day Holter ECGs 1, 2, 3, 6, 12 months postablation to evaluate ERAF. Results Acute PVI was reached in 100% of group 2 and in 99% of group 1. Shorter procedure durations (98.0 ± 21.9 vs. 114.3 ± 18.7 min, P < 0.05) but extended fluoroscopy times (15.4 ± 3.9 vs. 10.0 ± 4.3 min, P < 0.05) were found in the CB-G2 group. Ten non-severe complications occurred (6 vs. 4 in group 1 and 2, P = 0.73). In group 2, five patients suffered from ERAF vs. seven patients in group 1 ( P = 0.67). The time until the occurrence of ERAF was shorter in group 2 (1 day (q1–q3: 1−4.5)) when compared with group 1 (22 (q1–q3: 6−54) days, P = 0.025). Conclusion ERAF rates were equal among groups; however, they occurred earlier in the initial phase after RFC ablation when compared with CB-G2. PVI utilizing cryoablation is associated with shorter procedure durations but extended fluoroscopy time while being similarly secure.

Background/Objectives: The companies concentrate in M&A or investment for leading a VR technology, which is the one of the biggest issues in ICT industry. As VR market gets bigger, the patent litigation of NPE comes to a threatening issue. This litigation consumes a lot of money and time, so for that it has a purpose to suggest the way to minimize a company’s damage. Methods/Statistical analysis: We will search whether the VR tech market develops or not, through the trend of patent application. As VR market gets bigger, we suggest the way to correspond to the litigation of NPE, which is the one of threatening issues. At first, by making a NPE list that is threatening for, monitoring patents that NPE is gathering with. Second, by monitoring VR tech patents, analyzes the related patents if there’s a patent gathered from NPE for the cases of changed authority. Third, acquiring a date of issue to correspond for patent litigation when submitted a VR tech application. Findings: As VR market gets bigger, companies are spending on research and development to secure a share of the market with the better technology. Applies for patent to exercise the right of this technology, there are some NPE which makes profit from the litigation between companies without spending on research and development. This is a way to correspond the litigation with these NPE, the company suggested the way to protect this right by monitoring a status of patent purchase in the area of research and development. Patents to continuous purchased and technologies with a potential source of litigation prevent by designing around a patent or reinforcing. And above all, the patent grant a right to the person who submit patent application first uses the provisional application that can preoccupy a filing date of patent. So for that, company may protect the final result, which researched and developed by spent time and expense, moreover expect to minimize the damage of company from the patent litigation t. Improvements/Applications: When the advanced patent was applied to the market retained VR technology, the company may minimize the damage from the patent litigation by securing the filing date of patent and corresponding of litigation through the NPE monitoring.