Success and complication rates of conduction system pacing: a meta-analytical observational comparison of left bundle branch area pacing and His bundle pacing.

BACKGROUND: Left bundle branch area pacing (LBBAP) and His bundle pacing (HBP) are the main strategies to achieve conduction system pacing (CSP), but only observational studies with few patients have compared the two pacing strategies, sometimes with unclear results given the different definitions of the feasibility and safety outcomes. Therefore, we conducted a meta-analysis aiming to compare the success and complications of LBBAP versus HBP. METHODS: We systematically searched the electronic databases for studies published from inception to March 22, 2023, and focusing on LBBAP versus HBP. The study endpoints were CSP success rate, device-related complications, CSP lead-related complications and non-CSP lead-related complications. RESULTS: Fifteen observational studies enrolling 2491 patients met the inclusion criteria. LBBAP led to a significant increase in procedural success [91.1% vs 80.9%; RR: 1.15 (95% CI: 1.08-1.22); p < 0.00001] with a significantly lower complication rate [1.8% vs 5.2%; RR: 0.48 (95% CI: 0.29-0.78); p = 0.003], lead-related complications [1.1% vs 4.3%; RR: 0.38 (95% CI: 0.21-0.72); p = 0.003] and lead failure/deactivation [0.2% vs 3.9%; RR: 0.16 (95% CI: 0.07-0.35); p < 0.00001] than HBP. No significant differences were found between CSP lead dislodgement and non-CSP lead-related complications. CONCLUSION: This meta-analysis of observational studies showed a higher success rate of LBBAP compared to HBP with a lower incidence of complications.

Safety and Performance of the Micra VR Leadless Pacemaker in a Japanese Cohort　- Comparison With Global Studies.

BACKGROUND: The Micra leadless pacemaker has demonstrated favorable outcomes in global trials, but its real-world performance and safety in a Japan-specific population is unknown.Methods and Results: Micra Acute Performance (MAP) Japan enrolled 300 patients undergoing Micra VR leadless pacemaker implantation in 15 centers. The primary endpoint was the acute (30-day) major complication rate. The 30-day and 6-month major complication rates were compared to global Micra studies. All patients underwent successful implantation with an average follow-up of 7.23±2.83 months. Compared with previous Micra studies, Japanese patients were older, smaller, more frequently female, and had a higher pericardial effusion risk score. 11 acute major complications were reported in 10 patients for an acute complication rate of 3.33% (95% confidence interval: 1.61-6.04%), which was in line with global Micra trials. Pericardial effusion occurred in 4 patients (1.33%; 3 major, 1 minor). No procedure or device-related deaths occurred. Frailty significantly improved from baseline to follow-up as assessed by Japan Cardiovascular Health Study criteria. CONCLUSIONS: In a Japanese cohort, implantation of the Micra leadless pacemaker had a high success rate and low major complication rate. Despite the Japan cohort being older, smaller, and at higher risk, the safety and performance was in line with global Micra trials.

Atrial Fibrillation and Transvenous Lead Extraction-A Comprehensive Subgroup Analysis of the GermAn Laser Lead Extraction RegistrY (GALLERY).

Background: Atrial fibrillation is the most common arrhythmia and has been described as driver of cardiovascular morbidity and risk factor for cardiac device-related complications, as well as in transvenous lead extraction (TLE). Objectives: Aim of this study was to characterize the procedural outcome and risk-factors of patients with atrial fibrillation (AF) undergoing TLE. Methods: We performed a subgroup analysis of all AF patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) database. Predictors for all-cause mortality were assessed. Results: A total number of 510 patients with AF were identified with a mean age of 74.0 ± 10.3 years. Systemic infection (38.4%) was the leading cause for TLE, followed by local infection (37.5%) and lead dysfunction (20.4%). Most of the patients (45.9%) presented with pacemaker systems to be extracted. The total number of leads was 1181 with a 2.3 ± 0.96 leads/patient. Clinical procedural success was achieved in 97.1%. Occurrence of major complications was 1.8% with a procedure-related mortality of 1.0%. All-cause mortality was high with 5.9% and septic shock being the most common cause. Systemic device infection (OR: 49.73; 95% CI: 6.56−377.09, p < 0.001), chronic kidney disease (CKD; OR: 2.67; 95% CI: 1.01−7.03, p = 0.048) and a body mass index < 21 kg/m2 (OR: 6.6; 95% CI: 1.68−25.87, p = 0.007) were identified as independent predictors for all-cause mortality. Conclusions: TLE in AF patients is effective and safe, but in patients with systemic infection the mortality due to septic shock is high. Systemic infection, CKD and body mass index <21 kg/m2 are risk factors for death in patient with AF undergoing TLE.

No Room for Excess Room: Cobra Head Deformity of Both Discs of an Amplatzer Atrial Septal Occluder Device.

To our knowledge, this is the first case in the literature citing cobra head deformity of both atrial discs. A large delivery sheath with excess room possibly led to deformity in our case. This case highlights the importance of following manufacturer- recommended sheath sizes for optimal device implantation.

Aquablation, Prostatic Urethral Lift, and Transurethral Water Vapor Therapy: A Comparison of Device-Related Adverse Events in a National Registry.

Purpose: Aquablation, prostatic urethral lift (PUL), and transurethral water vapor therapy (TWVT) have demonstrated efficacy for the treatment of benign prostatic hyperplasia (BPH). Our objective was to describe device malfunctions and complications to help guide procedural selection and performance. Materials and Methods: The Manufacturer and User Facility Device Experience (MAUDE) database was examined for reports related to the use of these three procedures for the treatment of BPH between January 1, 2015, and July 1, 2020. Reports were evaluated for device malfunctions and surgical complications using a previously described externally validated classification system developed for the MAUDE database. Chi square analysis was used for statistical comparison between groups. Results: A total of 391 adverse events were reported: aquablation (n = 102), PUL (n = 132), and TWVT (n = 157). There were 79 (78%) severe or life-threatening adverse events for aquablation vs 69 (52%) for PUL vs 24 (15%) for TWVT (p < 0.001). There were 4 cases of rectal perforation with aquablation and 25 cases of the PUL implants needing to be removed or causing a problem with a later procedure. Blood transfusion frequencies were aquablation-32 (31%), PUL-21 (16%), and TWVT-1 (1%). The most common device malfunctions were: aquablation-motion error (n = 8), handpiece fracture/attachment malfunction (n = 8); PUL-device misfire (n = 27), needle fragmentation (n = 21); TWVT-unresolvable error message (n = 19). Conclusions: In a national database, aquablation and PUL had noteworthy complications or device-related malfunctions such as rectal perforation and the improper placement or failed deployment of the PUL implants. Both patients and providers should be aware of potential risks when selecting these novel BPH treatments.

A cross-sectional analysis of 284 complications for lumbar disc replacements from medical device reports maintained by the United States Food and Drug Administration.

BACKGROUND CONTEXT: Lumbar disc replacement (LDR) is a motion sparing procedure for degenerative disc disease. When compared to lumbar fusion, this procedure may reduce complications, reoperations, operative time, and length of stay. However, the extent of overall complications related to LDR has not been well defined in the literature. PURPOSE: Demonstrate the complication profile of popular LDR implants reported to the Food and Drug Administration (FDA). STUDY DESIGN: Retrospective database review. PATIENT SAMPLE: Nationwide database of reported complications related to LDR products from patients throughout the country. OUTCOME MEASURES: Complications related to LDR. METHODS: Data files from January 1, 2004 to April 1, 2021 were queried using the publicly accessible Manufacturer and User Facility Device Experience (MAUDE) database and Alternative Summary Reporting program. Three LDR ("Charité," "Prodisc-L," and "Activ L") products were analyzed for complications. Data collected included the date the reports were received by the FDA, the type of complication, complication event description, and the source of the report. The complication event description was utilized to determine the completion of the investigation. Entries with insufficient information were excluded. Complications were further divided into two categories, device and non-device related. RESULTS: A total of 431 complication entries were found between January 1, 2004, and April 1, 2021. After screening for duplicates and events with insufficient information there were 284 total complications. The total complications were then further divided into implant and non-implant related. The five most common overall complications were lumbar pain (49 entries, 17.25%), migration of implant (42 entries, 14.78%), polyethylene dislodged (37 entries, 13.0%), insertion of device problem (37 entries, 13.0%), device handling problem (12 entries, 4.22%). The most common implant related complication, along with the number of MAUDE entries for each implant was migration of implant for Charité (n=6); Migration of implant for ActivL (n=24); Polyethylene dislodged for ProdiscL (n=32). Of the 284 total complications analyzed, 86 (30.28%) of the entries were deemed "investigation completed." The majority of reports were submitted from the manufacturer and company representative (66.2%, 14.8 % respectively). There were no entries related to LDR within the Alternative Summary Reporting search. CONCLUSIONS: This study outlined the complications of LDR implants from the MAUDE database which have not always been highlighted in previously published studies. The findings of this study provide insight into the potential targets for improvement in future LDR design and surgical techniques to reduce complications and ensure the safe utilization of these implants.

Outflow graft obstruction in patients with the HM 3 LVAD: A percutaneous approach.

BACKGROUND: The use of the HeartMate 3 (HM3) left ventricular assist device (LVAD) is expanding. Despite being associated with lower rates of adverse events and increased survival, outflow graft obstruction (OGO) has been reported in patients with HM3. The incidence and best management of this serious complication remain unclear. METHODS: We describe six cases of HM3 OGO occurring in five patients in our institutional HM3 cohort. Four cases underwent computed tomography angiography and in two percutaneous angiography was directly performed to confirm the diagnosis. In four cases, percutaneous repair of the OG was performed using common interventional cardiology (IC) techniques. RESULTS: Our institutional incidence of OGO was 7% (event rate of 0.05 per patient year); much higher than the previously reported incidence of 1.6%. All cases occurred in the bend relief covered segment. Only two patients had apparent OG twisting, and in two, OGO occurred despite placement of an anti-twist clip at the time of implant. External compression seems to play a role in most cases. Balloon "graftoplasty" and stent deployment via the femoral artery alleviated the obstruction and normalized LVAD flow in all patients who underwent percutaneous repair. The use of self-expanding stents allowed for downsizing of the procedural access site to 10 Fr. No serious procedure-related complications occurred. CONCLUSION: OGO is common in HM3 patients, external compression due to biomaterial accumulated surrounding the OG is a common etiology. Percutaneous repair using standard IC techniques is safe and feasible in cases of compression with or without partial twisting.

Pacemaker lead-associated tricuspid regurgitation in patients with or without pre-existing right ventricular dilatation.

BACKGROUND: Transcatheter tricuspid valve intervention became an option for pacemaker lead-associated tricuspid regurgitation. This study investigated the progression of tricuspid regurgitation (TR) in patients with or without pre-existing right ventricular dilatation (RVD) undergoing pacemaker implantation. METHODS: Patients were included if they had implantation of transtricuspid pacemaker lead and completed echocardiography before and after implantation. The cohort was divided in patients with and without RVD (cut-off basal RV diameter ≥ 42 mm). TR was graded in none/mild, moderate, and severe. Worsening of one grade was defined as progression. Survival analyses were plotted for 10 years. RESULTS: In total, 990 patients were analyzed (24.5% with RVD). Progression of TR occurred in 46.1% of patients with RVD and in 25.6% of patients without RVD (P < 0.001). Predictors for TR progression were RV dilatation (OR 2.04; 95% CI 1.27-3.29; P = 0.003), pre-existing TR (OR 4.30; 95% CI 2.51-7.38; P < 0.001), female sex (OR 1.68; 95% CI 1.16-2.43; P = 0.006), single RV lead (OR 1.67; 95% CI 1.09-2.56; P = 0.018), mitral regurgitation (OR 2.08; 95% CI 1.42-3.05; P < 0.001), and enlarged left atrium (OR 1.98; 95% CI 1.07-3.67; P = 0.03). Survival-predictors were pacemaker lead-associated TR (HR 1.38; 95% CI 1.04-1.84; P = 0.028), mitral regurgitation (HR 1.34; 95% CI 1.02-1.77; P = 0.034), heart failure (HR 1.75; 95% CI 1.31-2.33; P < 0.001), kidney disease (HR 1.62; 95% CI 1.25-2.11; P < 0.001), and age ≥ 80 years (HR 2.84; 95% CI 2.17-3.71; P < 0.001). CONCLUSIONS: Patients with RVD receiving pacemaker suffered from increased TR progression, leading to decreased survival.

Transvenous extraction of permanent pacemaker and defibrillator leads: Reduced procedural complexity and higher procedural success rates in patients with infective versus noninfective indications.

INTRODUCTION: Transvenous lead extraction (TLE) is critical in the long-term management of patients with cardiac implanted electronic devices (CIEDs). The aim of the study is to evaluate the outcomes of TLE and to investigate the impact of infection. METHODS AND RESULTS: Data of patients undergoing extraction of permanent pacemaker and defibrillator leads during October 2014-September 2019 were prospectively analyzed. Overall, 242 consecutive patients (aged 71.0 ± 14.0 years, 31.4% female), underwent an equal number of TLE operations for the removal of 516 leads. Infection was the commonest indication (n = 201, 83.1%). Mean implant-to-extraction duration was 7.6 ± 5.4 years. Complete procedural success was recorded in 96.1%, and clinical procedural success was achieved in 97.1% of attempted lead extractions. Major complications occurred in two (0.8%) and minor complications in seven (2.9%) patients. Leads were removed exclusively by using locking stylets in 65.7% of the cases. In the subgroup of noninfective patients, advanced extraction tools were more frequently required compared to patients with CIED infections, to extract leads (success only with locking stylet: 55.8% vs. 67.8%, p = .032). In addition, patients without infection demonstrated lower complete procedural success rates (90.7% vs. 97.2%, p = .004), higher major complication rates (2.4% vs. 0.5%, p = .31) and longer procedural times (136 ± 13 vs. 111 ± 15 min, p = .001). CONCLUSIONS: Our data demonstrate high procedural efficacy and safety and indicate that in patients with noninfective indications, the procedure is more demanding, thus supporting the hypothesis that leads infection dissolves and/or prohibits the formation of fibrotic adherences.

A cross-sectional analysis of 1347 complications for cervical disc replacements from medical device reports maintained by the United States Food and Drug Administration.

BACKGROUND CONTEXT: Cervical disc replacement (CDR) has increased in popularity over the past decade based on published outcomes from FDA IDE studies with narrowly defined inclusion and exclusion criteria. A low rate of complications was noted in these studies. The broader complication profile for CDR in widespread clinical practice has yet to be described. PURPOSE: To outline the complications reported to the FDA regarding commonly used CDR products STUDY DESIGN/SETTING: Retrospective database review PATIENT SAMPLE: Nationwide database of reported complications related to CDR products from patients across the country OUTCOME MEASURES: Complications related to CDR METHODS: We queried the MAUDE database and Alternative Summary Reporting (ASR) data files submitted between January 2005 to March 2020. The complications listed for seven FDA-approved CDR implants were analyzed. The entries in the databases were cataloged for complication type, date of entry, source of report, and whether the investigation was "complete". Reports that had too little information to extract relevant data were excluded. RESULTS: There were 1,517 entries identified in the MAUDE database. After removal of duplicate entries and entries without sufficient information, there were 1,347 entries analyzed. The top five complications were (1) migration of implant (338 entries, 25.2%) (2) insertion problem/failure (312 entries, 23.3%) (3) neck pain (203 entries, 15.2%) (4) heterotopic ossification (108 entries, 8.1%) and (5) radiculopathy (90 entries, 8.1%). The number of analyzed implant-related MAUDE entries and most common implant-related complication for each implant was 209 entries for insertion problem/failure for Mobi-C; 158 entries for migration of implant for ProDisc-C; 154 entries for insertion problem/failure for Bryan cervical disc; 130 entries for migration of implant for Prestige cervical disc; 49 entries for migration of implant for PCM cervical disc; 12 entries for migration of implant for M6 and 10 entries for migration of implant for Secure-C. Only 263 entries (19.5%) were deemed "complete". Most entries were from the manufacturer/company representative/distributor (923 entries, 70%). There were no entries related to cervical disc replacement devices within the ASR data. CONCLUSIONS: The MAUDE database highlights complications related to CDR implants that may not be emphasized in currently published studies. It is important to understand this broad complication profile for CDR to ensure safe utilization of this new technology.

Recomendações para o manejo de dispositivos cardíacos eletrônicos implantáveis post mortem / Recommendations for the post-mortem management of cardiac implantable electronic devices

O manejo de dispositivos cardíacos eletrônicos implantáveis de pacientes que evoluem a óbito tem sido motivo de controvérsia. Em nosso meio, não há recomendações uniformes, estando baseadas exclusivamente em protocolos institucionais e em costumes regionais. Quando o cadáver é submetido para cremação, além de outros cuidados, recomenda-se a retirada do dispositivo devido ao risco de explosão e dano do equipamento crematório. Principalmente no contexto da pandemia causada pelo SARS-Cov-2, a orientação e organização de unidades hospitalares e serviços funerários é imprescindível para minimizar o fluxo de pessoas em contato com fluidos corporais de indivíduos falecidos por COVID-19. Nesse sentido, a Sociedade Brasileira de Arritmias Cardíacas elaborou este documento com orientações práticas, tendo como base publicações internacionais e recomendação emitida pelo Conselho Federal de Medicina do Brasil.

The management of cardiac implantable electronic devices after death has become a source of controversy. There are no uniform recommendations for such management in Brazil; practices rely exclusively on institutional protocols and regional custom. When the cadaver is sent for cremation, it is recommended to remove the device due to the risk of explosion and damage to crematorium equipment, in addition to other precautions. Especially in the context of the SARS-CoV-2 pandemic, proper guidance and organization of hospital mortuary facilities and funeral services is essential to minimize the flow of people in contact with bodily fluids from individuals who have died with COVID-19. In this context, the Brazilian Society of Cardiac Arrhythmias has prepared this document with practical guidelines, based on international publications and a recommendation issued by the Brazilian Federal Medical Council.

Use of laser iridoplasty in iris incarceration of a glaucoma drainage device.

PURPOSE: To describe the use of laser iridoplasty to release iris incarceration occluding a glaucoma drainage device. OBSERVATIONS: A 46-year-old male with uncontrolled type 1 diabetes mellitus presented with neovascular glaucoma and subsequently had a glaucoma drainage device implanted for control of intraocular pressure. One month post-operatively, he presented with a significantly elevated intraocular pressure, thought to be due to poor drainage from iris incarceration in the device. He had recently developed a vitreous hemorrhage and hyphema, and he had florid neovascularization of the iris, thus raising concern that traditional neodymium:yttrium-aluminum-garnet (Nd:YAG) iridotomy would promote re-formation of the hyphema. Thus, a diode solid-state laser iridoplasty was performed around the site of incarceration, resulting in successful release of the iris from the device without hyphema formation. CONCLUSIONS AND IMPORTANCE: Glaucoma drainage devices are effective tools to help control intraocular pressure. However, they risk post-operative complications, such as iris incarceration within the device, that prevents them from functioning properly. In such cases, Nd:YAG laser iridotomy is often used around the site of incarceration, thus releasing it from the device. In this case report, we describe how diode solid-state laser can be used to release the iris incarceration via iridoplasty. Such iridoplasty may result in a decreased likelihood of hyphema formation as compared to Nd:YAG iridotomy, so this provides a superior alternative in patients with a propensity for developing a hyphema, such as in patients with iris neovascularization.

Comparison of device-specific adverse event profiles between Impella platforms.

BACKGROUND: The Impella (Abiomed) ventricular support system is a family of temporary mechanical circulatory support (MCS) devices used to treat patients with cardiogenic shock, acute cardiogenic decompensation, and for high-risk percutaneous or surgical revascularization. These devices include the percutaneously implanted 2.5/cardiac power (CP) and the surgically implanted 5.0/left direct (LD). Despite the beneficial effects and increased usage of these devices, data to assess adverse outcomes and guide clinician decision-making between the Impella CP and 5.0/LD are limited. METHODS: This is a retrospective analysis of 91 consecutive patients who required at least 24 h of Impella support, from January 1, 2015 to December 31, 2019. Groups were stratified based on either initial Impella CP or 5.0/LD placement. Clinical outcomes and in-hospital complications were compared. RESULTS: Impella CP was implanted in 66 patients (mean age: 61 ± 15 years, male 71.2%) and Impella 5.0/LD was implanted in 25 patients (mean age: 62 ± 9 years, male 84.0%). There was greater stability of device position (p = .033), less incidence of hemolysis (p < .001), and less frequent need for additional MCS (p = .001) in patients implanted with the Impella 5.0/LD compared with Impella CP in this study cohort. Patients with Impella 5.0/LD were more likely to survive from Impella and survive to discharge. CONCLUSIONS: This study suggests that for patients who require temporary MCS for more than 24 h, the Impella 5.0/LD may have a more favorable device-specific adverse profile compared with the Impella CP.

Impact on All-Cause and Cardiovascular Mortality of Cardiac Implantable Electronic Device Complications: Results From the POINTED Registry.

OBJECTIVES: This study aimed to determine how CIED-related complications affect all-cause and cardiovascular mortality over a long-term follow-up. BACKGROUND: Although complications related to implantable electronic device (CIED) implantation are steadily increasing in Europe, little is known about the impact of complications other than device infection on mortality. METHODS: The POINTED (Impact on Patient Outcome and health care utilization of cardiac ImplaNTable Electronic Device complications) registry was a prospective, multicenter, observational study designed to collect data on complications in patients undergoing de novo CIED implantation (NCT03612635). All consecutive patients were enrolled in 6 high-volume centers between January 2010 and December 2012 and followed up for at least 3 years. A complication was defined as any CIED-related adverse event requiring surgical revision after implantation. RESULTS: During follow-up (median 56.9 months), we observed 283 complications in 263 of 2811 consecutive patients (71 ± 14 years of age, 66.7% men). Early complications (≤30 days) were associated with significantly lower cumulative survival from cardiovascular death in comparison with late complications and with freedom from complications. On multivariate analysis, early complication, pneumothorax, and pocket hematoma were significantly associated with a higher risk of all-cause death, while device infection remained the only complication significantly associated with a higher risk of cardiovascular death. CONCLUSIONS: All CIED-related complications are associated with an increased risk of cardiovascular mortality, and early complications are associated with an increased risk of all-cause mortality. These data underline the importance of specific measures aimed at reducing CIED complications and improving their management.

Financial and resource costs of transvenous lead extraction in a high-volume lead extraction centre.

OBJECTIVES: Transvenous lead extraction (TLE) poses a significant economic and resource burden on healthcare systems; however, limited data exist on its true cost. We therefore estimate real-world healthcare reimbursement costs of TLE to the UK healthcare system at a single extraction centre. METHODS: Consecutive admissions entailing TLE at a high-volume UK centre between April 2013 and March 2018 were prospectively recorded in a computer registry. In the hospital's National Health Service (NHS) clinical coding/reimbursement database, 447 cases were identified. Mean reimbursement cost (n=445) and length of stay (n=447) were calculated. Ordinary least squares regressions estimated the relationship between cost (bed days) and clinical factors. RESULTS: Mean reimbursement cost per admission was £17 399.09±£13 966.49. Total reimbursement for all TLE admissions was £7 777 393.51. Mean length of stay was 16.3±15.16 days with a total of 7199 bed days. Implantable cardioverter-defibrillator and cardiac resynchronisation therapy defibrillator devices incurred higher reimbursement costs (70.5% and 68.7% higher, respectively, both p<0.001). Heart failure and prior valve surgery also incurred significantly higher reimbursement costs. Prior valve surgery and heart failure were associated with 8.3 (p=0.017) and 5.5 (p=0.021) additional days in hospital, respectively. CONCLUSIONS: Financial costs to the NHS from TLE are substantial. Consideration should therefore be given to cost/resource-sparing potential of leadless/extravascular cardiac devices that negate the need for TLE particularly in patients with prior valve surgery and/or heart failure. Additionally, use of antibiotic envelopes and other interventions that reduce infection risk in patients receiving transvenous leads should be considered.

Detection and management of inadequate vascular access device implantation in the subclavian artery. / Detección y manejo de implantación inadecuada de reservorio venoso central en arteria subclavia.

We present a case of a female patient with ovarian cancer who had an inadvertent vascular access device implantation in the subclavian artery, being detected after 10 days. She was successfully treated with a covered stent without immediate complications.

Inappropriate implantable cardioverter defibrillator shocks due to atrial far-field on the tip-to-ring channel for lead dislodgement.

We reported a case of inappropriate implantable cardioverter defibrillator shocks, due to atrial far-field on the tip-to-ring channel of the fast electrical activity during atrial fibrillation, caused by lead dislocation in the right ventricle outflow tract. During these episodes the can-to-right ventricle coil signal correctly recorded the ventricular activity. The shock storm stopped when an antitachycardia pacing restored sinus rhythm.

Predictors of mortality and outcomes in transvenous lead extraction for systemic and local infection cohorts.

BACKGROUND: Transvenous lead extraction (TLE) may be necessary due to infective and noninfective indications. We aim to identify predictors of 30-day mortality and risk factors between infective versus noninfective groups and systemic versus local infection subgroups. METHODS: A total of 925 TLEs between October 2000 and December 2016 were prospectively collected and dichotomized (infective group n = 505 vs noninfective group n = 420 and systemic infection n = 164 vs local infection n = 341). RESULTS: All-cause major complication including deaths was significantly higher (5.1%, n = 26 vs 1.2%, n = 5, P = 0.001) as well as 30-day mortality (4.0%, n = 20 vs 0.2%, n = 1, P < 0.001) in the infective group compared to the noninfective group. Both subgroups (systemic vs local infection) were balanced for demographics. All-cause major complication including deaths was significantly higher (9.1%, n = 15 vs 3.2%, n = 11, P = 0.008) as well as all-cause 30-day mortality (7.9%, n  = 13 vs 2.1%, n = 7, P = 0.003) in the systemic infection subgroup compared to the local infection subgroup. CONCLUSION: Patients undergoing TLE for infective indications are at greater risk of 30-day all-cause mortality compared to noninfective patients. Patients undergoing TLE for systemic infective indications are at greater risk of 30-day all-cause mortality compared to patients with local infection. Renal impairment, systemic infection, and elevated preprocedure C-reactive protein are independent predictors of 30-day all-cause mortality in patients undergoing TLE for an infective indication.

Safety of insertion of the copper IUD and LNG-IUS in nulliparous women: a systematic review.

OBJECTIVE: Intrauterine contraception (IUC) is one of the more effective contraceptive methods for women at highest risk of unintended pregnancy. This includes younger, often nulliparous, women; however, uptake has been relatively low in this group. METHODS: In February 2017 we conducted a systematic review of randomised controlled trials, prospective and retrospective observational studies to identify barriers to IUC use in nulliparous women. RESULTS: Study quality was poor. No differences in rates of infection or expulsions between nulliparous and parous were seen. Fertility rates following removal appeared no different from the general population. Higher rates insertion difficulty, insertion failure and pain during insertion were observed in nulliparous women. CONCLUSION: A long-acting reversible contraceptive method such as IUC reduces the risk of unintended pregnancy since user failure is minimised. Evidence-based information about the advantages and disadvantages of IUC is required to inform decision-making and dispel any myths and misperceptions. Potential barriers to IUC use in nulliparous women, particularly concerns around infection, significantly higher rates of device expulsion and adverse effects on fertility, do not appear to be justified. IUC is appropriate for all medically-eligible women, including nulliparous women, and should be included in the range of contraceptive options discussed during counselling.