Search

Background: Present guidelines endorse complete removal of cardiovascular implantable electronic devices (pacemakers/defibrillators), including extraction of all intracardiac electrodes, not only for systemic infections, but also for localized pocket infections., Objectives: The authors evaluated the efficacy of delivering continuous, in situ-targeted, ultrahigh concentration of antibiotics (CITA) into the infected subcutaneous device pocket, obviating the need for device/lead extraction., Methods: The CITA group consisted of 80 patients with pocket infection who were treated with CITA during 2007-2021. Of them, 9 patients declined lead extraction because of prohibitive operative risk, and 6 patients had questionable indications for extraction. The remaining 65 patients with pocket infection, who were eligible for extraction, but opted for CITA treatment, were compared with 81 patients with pocket infection and similar characteristics who underwent device/lead extraction as primary therapy., Results: A total of 80 patients with pocket infection were treated with CITA during 2007-2021. CITA was curative in 85% (n = 68 of 80) of patients, who remained free of infection (median follow-up 3 years [IQR: 1.0-6.8 years]). In the case-control study of CITA vs device/lead extraction, cure rates were higher after device/lead extraction than after CITA (96.2% [n = 78 of 81] vs 84.6% [n = 55 of 65]; P = 0.027). However, rates of serious complications were also higher after extraction (n = 12 [14.8%] vs n = 1 [1.5%]; P = 0.005). All-cause 1-month and 1-year mortality were similar for CITA and device/lead extraction (0.0% vs 3.7%; P = 0.25 and 12.3% vs 13.6%; P = 1.00, respectively). Extraction was avoided in 90.8% (n = 59 of 65) of extraction-eligible patients treated with CITA., Conclusions: CITA is a safe and effective alternative for patients with pocket infection who are unsuitable or unwilling to undergo extraction. (Salvage of Infected Cardiovascular Implantable Electronic Devices [CIED] by Localized High-Dose Antibiotics; NCT01770067)., Competing Interests: Funding Support and Author Disclosures Dr Topaz is developer and patent holder of TopClosure Tension Relief and Vcare α and MeCare systems, and heads and holds shares in IVT Medical, the manufacturer of these devices. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction: Conflicting data exist on the prognostic significance of permanent pacemaker (PPM) implantation after transcatheter aortic valve replacement (TAVR)., Objective: The purpose of this study was to evaluate whether PPM implantation after TAVR is associated with adverse outcomes., Methods: A retrospective analysis of a cohort comprised patients enrolled in a prospective registry between 2008 and 2019. Participants were allocated into 3 groups: patients without a prior pacemaker (n = 930 [75%]), those with previous pacemaker implantation (n = 118 [10%]), and those with pacemaker implantation after TAVR (n = 191 [15%]). The primary outcome included death and heart failure hospitalizations at 1 year. Secondary outcomes included death and heart failure hospitalizations stratified by pacing burden., Results: A total of 1239 patients underwent TAVR with a median follow-up period of 2.3 years (interquartile range 1-4 years). Patients with previous and new pacemaker implantation were older (84 [80-88], 84 [80-88], and 82 [78-86] years; P = .009) and had lower baseline left ventricular ejection fraction (50% ± 15%, 55% ± 12%, and 56% ± 12%; P < .001). Patients who underwent new pacemaker implantation had higher combined outcome of death and heart failure hospitalizations (21%,12%, and 14%; P = .01). New pacemaker implantation was associated with almost twice the risk of 1-year mortality (odds ratio 1.85; 95% confidence interval 1.13-3.02; P = .014). Pacing burden, however, was not associated with the primary outcome. Furthermore, no significant difference was observed at long-term follow-up (cumulative probability to develop the primary end point at 3 years was 57% ± 2% [without PPM], 57% ± 6% [prior PPM], 54% ± 4% [new PPM]; P = .52)., Conclusion: Pacemaker implantation after TAVR is associated with higher 1-year adverse outcome, but this attenuates over time, suggesting that competing factors may play a role. Interestingly, pacing burden is not associated with adverse clinical course., (Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Aims: The aims of this study is to characterize the transvenous lead extraction (TLE) population with active (A) compared with passive fixation (PFix) leads and to compare the safety, efficacy, and ease of extracting active fixation (AFix) compared with PFix right atrial (RA) and right ventricular (RV) leads., Methods and Results: The European Lead Extraction ConTRolled Registry (ELECTRa) was analysed. Patients were divided into three groups; those with only AFix, only PFix, and combined Fix leads. Three outcomes were defined. Difficult extraction, complete radiological, and clinical success. Multivariate model was used to analyse the independent effect of Fix mechanism on these outcomes. The study included 2815 patients, 1456 (51.7%) with only AFix leads, 982 (34.9%) with only PFix leads, and 377 (13.4%) with combined Fix leads. Patients with AFix leads were younger with shorter lead dwelling time. Infection was the leading cause for TLE among the combined Fix group with lowest rates among AFix group. No difference in complications rates was noted between patients with only AFix vs. PFix leads. Overall, there were 1689 RA (1046 AFix and 643 PFix) and 2617 RV leads (1441 AFix and 1176 PFix). Multivariate model demonstrated that PFix is independently associated with more difficult extraction for both RA and RV leads, lower radiological success in the RA but has no effect on clinical success., Conclusion: Mechanism of Fix impact the ease of TLE of RA and RV leads and rates of complete radiological success in the RA but not clinical success. These findings should be considered during implantation and TLE procedures., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

Heart transplantation (HT) in patients with prior cardiovascular implantable electronic devices (CIEDs) is becoming more common, in parallel with the increased use of CIEDs for patients with advanced heart failure. Complete removal of CIED components during HT is not always feasible, and it is thus surprising that the literature addressing the implications of retained CIED components is limited. Indeed, there are neither guidelines nor consensus regarding the need for removal of these CIED fragments. This issue is nonetheless becoming important in light of the increase in the percentage of HT candidates having CIEDs, on the one hand, and newer therapeutic immunosuppressive protocols with higher bacterial infection potential, on the other. Thus, with the aim to study the implications of retained CIED fragments as a step towards establishing a therapeutic approach for the unique population of HT recipients with CIED remnants, we present here a case series of HT patients with retained CIED fragments who developed complications of infections together with a review of the available literature.

Background: The prognosis of patients with untreated cardiac implantable electronic device (CIED) infection is poor. Whether removal of all leads by a successful transvenous lead extraction (TLE) procedure changes the prognosis is unclear., Objective: To identify predictors of mortality in patients with CIED infection despite successful TLE., Methods: Retrospective single-center analysis of prospectively collected database from consecutive patients undergoing TLE at our center. Predictors for mortality were identified and a score predicting high mortality rate was calculated., Results: A total of 371 consecutive patients underwent TLE, of whom 337 (90.8%) had complete hardware removal. Most were extracted due to infectious causes (81.3%). Approximately one-third (35%) died during a mean follow-up of 1056 ± 868 days. There was significantly higher mortality observed in the infectious group. Multivariate logistic regression models for infectious group only identified creatinine and albumin measurements as risk markers for 30 days mortality (odds ratio [OR], 1.68; 95% confidence interval [CI], 1.19-2.38; P = .003 and OR, 0.4; 95% CI, 0.16-0.97; P = .039, respectively). A risk score was created based on cutoff values of creatinine ≥2md/dL (1 point) and albumin ≤3.5 g/dL (1 point). A value of 2 points predicted a 50% chance of 30-day mortality and a 75% chance of 1-year mortality (P < .0001 for both)., Conclusions: Creatinine and albumin can be used as a combined risk score to successfully identify patients at risk of death despite undergoing a successful TLE procedure for infectious reasons. This score could help decision making when contemplating on conservative antibiotic treatment vs TLE., (© 2020 Wiley Periodicals, Inc.)

Aims: The present study sought to determine predictors for success and outcomes of patients who underwent cardiac implantable electronic devices (CIED) extraction indicated for systemic or local CIED related infection in particular where complete lead removal could not be achieved., Methods and Results: ESC-EORP ELECTRa (European Lead Extraction ConTRolled Registry) is a European prospective lead extraction registry. Out of the total cohort, 1865/3510 (52.5%) patients underwent removal due to CIED related infection. Predictors and outcomes of failure were analysed. Complete removal was achieved in 1743 (93.5%) patients, partial (<4 cm of lead left) in 88 (4.7%), and failed (>4 cm of lead left) in 32 (1.8%) patients. Removal success was unrelated to type of CIED infection (pocket or systemic). Predictors for failure were older leads and older patients [odds ratio (OR) 1.14 (1.08-1.19), P < 0.0001 and OR 2.68 (1.22-5.91), P = 0.0146, respectively]. In analysis by lead, predictors for failure were: pacemaker vs. defibrillator removal and failure to engage the locking stylet all the way to the tip [OR 0.20 (0.04-0.95), P = 0.03 and OR 0.32 (0.13-0.74), P = 0.008, respectively]. Significantly higher complication rates were noted in the failure group (40.6% vs. 15.9 for partial and 8.7% for success groups, P < 0.0001). Failure to remove a lead was a strong predictor for in hospital mortality [hazard ratio of 2.05 (1.01-4.16), P = 0.046]., Conclusion: A total of 6.5% of infected CIED patients failed attempted extraction. Only were >4 cm of lead remained resulted in higher procedural complications and mortality rates., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Introduction: Cardiac implantable electronic device (CIED) trans venous lead extraction (TLE) is technically challenging. Whether the use of a laser sheath reduces complications and improves outcomes is still in debate. We therefore aimed at comparing our experience with and without laser in a large referral center., Methods: Information of all patients undergoing TLE was collected prospectively. We retrospectively compared procedural outcomes prior to the introduction of the laser sheath lead extraction technique to use of laser sheath., Results: During the years 2007-2017, there were 850 attempted lead removals in 407 pts. Of them, 339 (83%) were extracted due to infection, device upgrade/lead malfunction in 42 (10%) cases, and other (7%). Complete removal (radiological success) of all leads was achieved in (88%). Partial removal was achieved in another 6% of the patients. Comparison of cases prior to and after laser technique introduction, showed that with laser, a significantly smaller proportion of cases required conversion to femoral approach [31/275 (6%) laser vs. 40/132 (15%) non-laser; p<0.001]. However, success rates of removal [259/275 (94%) vs. 124/132 (94%) respectively; p = 0.83] and total complication rates [35 (13%) vs. 19 (14%) respectively; p = 0.86] did not differ prior to and after laser use. In multivariate analysis, laser-assisted extraction was an independent predictor for no need for femoral extraction (OR = 0.39; 95% CI 0.23-0.69; p = 0.01)., Conclusion: Introduction of laser lead removal resulted in decreased need to convert to femoral approach, albeit without improving success rates or preventing major complications., Competing Interests: The authors have declared that no competing interests exist.

Background: Pacemaker pocket early post-implantation inflammation (EPII) is defined as clinical signs of local erythema without any systemic signs of infection occurring early after implantation. Data on the best treatment regimen for apparent superficial EPII is scarce., Objectives: To investigate the prognostic value of medical treatment, rather than extraction surgery, in patients with EPII., Methods: Data from 6013 consecutive patients who underwent cardiac implantable electronic device (CIED) implantation or replacement from 2007-2015 were retrospectively analyzed; 40 (0.7%) presented with EPII. Our goal was the absence of major complications and to avoidance of extraction., Results: Patients with EPII were initially treated medically. Nineteen (47%) (group A) recovered with antibiotic treatment only. In the other 21 patients (53%) (group B), CIED extraction was performed. Group B had more major complications compared to group A (15 [71%] vs. 0 [0%], P < 0.001). The only significant difference in baseline characteristics was history of non-initial procedure. While 86% of group B patients had a previous non-initial procedure, only 53% of group A patients underwent previous replacement (P < 0.05). In multivariate analysis, previous non-initial procedure was the only predictor for need of extraction at 1 year, hazard ratio 3.5, 95% confidence interval 1.001-11.73, P < 0.05., Conclusions: Conservative treatment in patients with EPII after non-initial procedure can lead to serious adverse events resulting in the need for extraction. Close follow-up and aggressive treatment should be considered early in the therapeutic course.

Permanent cardiac pacing is the only effective solution for patients with symptomatic bradycardia and heart block. About 10% of patients undergoing implantation of the conventional pacing system develop complications related to the subcutaneous pocket or the leads and in pediatric patients lead problems may rise in up to 30% of the patients. The leadless pacemaker devices were developed in order to minimize some of those complications. We present a case of an 11-year-old patient who presented after the sudden death of his older brother, with recurrent episodes of syncope and documented prolonged sinus pauses. The patient underwent percutaneous implantation of a leadless Micra™ pacemaker device with optimal results.

Background: Transvenous lead extraction remains a challenging procedure with inherent risk and associated complications., Objective: We sought to characterize and evaluate predictors of delayed shock after transvenous lead extraction with no intraprocedural complications., Methods: We retrospectively analyzed data of 217 consecutive patients who underwent extraction between 2010 and 2015. The primary end point was sudden onset of shock more than 4 hours after the completion of the procedure. Shock was defined as at least 30 minutes of persistent hypotension, necessitating vasopressors. Patients with mechanical or hemorrhagic shock were excluded., Results: Seventeen patients (9%) developed delayed shock during the first 24 hours. Reasons for shock were sepsis (47%) or no apparent cause (53%). In multivariate analysis, patients with delayed shock had significantly lower glomerular filtration rate (median estimated glomerular filtration rate 53 mL/min vs 73 mL/min; P = .001), had more signs of systemic infection before extraction (fever, bacteremia, and leukocytosis; P < .05), and had more lead/tip remnants (29% vs 3%; P < .001). Patients presenting with delayed shock had significantly higher mortality rates at 1-year follow-up (10 [59%] vs 40 [23%], respectively; P < .01). Multivariate analysis adjusted for 1-year mortality risk was 114% higher (hazard ratio 2.14; 95% confidence interval 1.02-4.47; P < .05) in patients presenting with delayed shock., Conclusion: We describe a previously unrecognized clinical phenomenon of delayed shock developing after extraction. Patients with predictors of this condition at baseline should be identified and followed up closely. Even with prompt treatment, long-term mortality rates remain high., (Copyright © 2017. Published by Elsevier Inc.)

Background: Transvenous lead extraction can lead to tricuspid valve damage., Objectives: To assess the incidence, risk factors and clinical outcome of tricuspid regurgitation (TR) following lead extraction., Methods: We prospectively collected data on patients who underwent lead extraction at the Sheba Medical Center prior to laser use (i.e., before 2012). Echocardiography results before and following the procedure were used to confirm TR worsening, defined as an echocardiographic increase of at least one TR grade. Various clinical and echocardiographic parameters were analyzed as risk factors for TR. Clinical and echocardiographic follow-up was conducted to assess the clinical significance outcome of extraction-induced TR., Results: Of 152 patients who underwent lead extraction without laser before 2012, 86 (56%) (192 electrodes) had echocardiography results before and within one week following the procedure. New or worsening TR was discovered in 13 patients (15%). Use of mechanical tools and younger age at extraction were found on multivariate analysis to be factors for TR development (P = 0.04 and P = 0.03 respectively). Average follow-up was 22.25 ± 21.34 months (range 8-93). There were no significant differences in the incidence of right-sided heart failure (50% vs. 23%, P = 0.192) or hospitalizations due to heart failure exacerbations (37.5% vs. 11%, P = 0.110). No patient required tricuspid valve repair or replacement. Death rates were similar in the TR and non-TR groups (20% vs. 33%)., Conclusions: TR following lead extraction is not uncommon but does not seem to affect survival or outcomes such as need for valve surgery. Its long-term effects remain to be determined.

Aims: To compare different coronary sinus (CS) leads and delivery systems (DSs) for left ventricular pacing., Methods and Results: Delivery systems-related (including CS dissection and dislocations during sheath/stylet removal) and lead-related (including failure to accomplish implantations and long-term malfunctions resulting in abandonment or repositioning/replacing of the lead) complications between systems and leads were compared. We used Medtronic (MDT) attain DS (n = 123) with over-the-wire (OTW) (4193, 4194) and stylet-driven (2187) leads, and Guidant (GDT) DS (n = 126) with Easytrak OTW leads (4513, 4518, and 4525). Coronory sinus dissection occurred in 6/123 (5%) cases using the MDT DS vs. 7/126 (6%) with GDT DS (P= NS). Dislocations during sheath/stylet removal occurred in 8/123 cases (6%) with MDT DS, and in 8/126 (6%) with GDT DS (P= NS). Failure to achieve successful implantation occurred in 6/32 (19%) of the 2187 leads, in 11/87(13%) of the 4193/4194 leads, in 7/94(7%) of the 4513/4518 leads, and in 4/29 (14%) of the 4525 leads (P= NS). Long-term lead-related complications occurred in 5/32 (15%) of the 2187 leads, 19/80 (23%) of the 4193/4194 leads, 19/93 (20%) of the 4513/4518 leads, and 2/28 (7%) of the 4525 leads (P= NS)., Conclusion: No significant differences in complication rates between systems and leads were observed.

Aims: To compare the clinical response of patients with right ventricular apical pacing (RVAP) upgraded to cardiac resynchronization therapy (CRT) to that of previously nonpaced heart failure (HF) patients who had de novo CRT implantation., Background: The role of CRT in patients with wide QRS and HF due to RVAP is less well established than in other CRT candidates., Methods: Ninety-eight consecutive patients with CRT were studied (mean age 70, mean ejection fraction 0.23). Group A: patients having RVAP prior to CRT implantation (n = 25), group B: patients without prior RVAP (n = 73). Clinical and echocardiographic parameters were recorded prior to, and 3 months after, CRT implantation., Results: Group A patients had a wider QRS at baseline compared to group B (203 +/- 32 ms vs 163 +/- 30 ms respectively, P < 0.001), and a shorter 6-minute walking distance (222 +/- 118 m vs 362 +/- 119 m, respectively, P < 0.005). Otherwise, clinical and echocardiographic parameters were not different. At follow up, group A patients had an average 0.7 +/- 0.5 decrease in their NYHA functional class, compared to 0.3 +/- 0.7 in group B patients (P < 0.05). Six-minute walking distance increased by 93 +/- 113 m in group A, versus 36 +/- 120 m in group B (P = 0.22). There was no difference in echocardiographic response to CRT between the groups., Conclusions: HF patients with prior RVAP demonstrate clinical improvement after upgrading to CRT that is comparable, and in some aspects, even better than that observed in HF patients with native conduction delay who undergo de novo CRT implantation.