The BLISTER Score: A Novel, Externally Validated Tool for Predicting Cardiac Implantable Electronic Device Infections, and Its Cost-Utility Implications for Antimicrobial Envelope Use.

BACKGROUND: Antimicrobial envelopes reduce the incidence of cardiac implantable electronic device infections, but their cost restricts routine use in the United Kingdom. Risk scoring could help to identify which patients would most benefit from this technology. METHODS: A novel risk score (BLISTER [Blood results, Long procedure time, Immunosuppressed, Sixty years old (or younger), Type of procedure, Early re-intervention, Repeat procedure]) was derived from multivariate analysis of factors associated with cardiac implantable electronic device infection. Diagnostic utility was assessed against the existing PADIT score (Prior procedure, Age, Depressed renal function, Immunocompromised, Type of procedure) in both standard and high-risk external validation cohorts, and cost-utility models examined different BLISTER and PADIT score thresholds for TYRX (Medtronic; Minneapolis, MN) antimicrobial envelope allocation. RESULTS: In a derivation cohort (n=7383), cardiac implantable electronic device infection occurred in 59 individuals within 12 months of a procedure (event rate, 0.8%). In addition to the PADIT score constituents, lead extraction (hazard ratio, 3.3 [95% CI, 1.9-6.1]; P<0.0001), C-reactive protein >50 mg/L (hazard ratio, 3.0 [95% CI, 1.4-6.4]; P=0.005), reintervention within 2 years (hazard ratio, 10.1 [95% CI, 5.6-17.9]; P<0.0001), and top-quartile procedure duration (hazard ratio, 2.6 [95% CI, 1.6-4.1]; P=0.001) were independent predictors of infection. The BLISTER score demonstrated superior discriminative performance versus PADIT in the standard risk (n=2854, event rate: 0.8%, area under the curve, 0.82 versus 0.71; P=0.001) and high-risk validation cohorts (n=1961, event rate: 2.0%, area under the curve, 0.77 versus 0.69; P=0.001), and in all patients (n=12 198, event rate: 1%, area under the curve, 0.8 versus 0.75, P=0.002). In decision-analytic modeling, the optimum scenario assigned antimicrobial envelopes to patients with BLISTER scores ≥6 (10.8%), delivering a significant reduction in infections (relative risk reduction, 30%; P=0.036) within the National Institute for Health and Care Excellence cost-utility thresholds (incremental cost-effectiveness ratio, £18 446). CONCLUSIONS: The BLISTER score (https://qxmd.com/calculate/calculator_876/the-blister-score-for-cied-infection) was a valid predictor of cardiac implantable electronic device infection, and could facilitate cost-effective antimicrobial envelope allocation to high-risk patients.

Cost-effectiveness analysis of leadless cardiac resynchronization therapy.

BACKGROUND: The Wireless Stimulation Endocardially for CRT (WiSE-CRT) system is a novel technology used to treat patients with dyssynchronous heart failure (HF) by providing leadless cardiac resynchronization therapy (CRT). Observational studies have demonstrated its safety and efficacy profile, however, the treatment cost-effectiveness has not previously been examined. METHODS: A cost-effectiveness evaluation of the WiSE-CRT System was performed using a cohort-based economic model adopting a "proportion in state" structure. In addition to the primary analysis, scenario analyses and sensitivity analyses were performed to test for uncertainty in input parameters. Outcomes were quantified in terms of quality-adjusted life year (QALY) differences. RESULTS: The primary analysis demonstrated that treatment with the WiSE-CRT system is likely to be cost-effective over a lifetime horizon at a QALY reimbursement threshold of £20 000, with a net monetary benefit (NMB) of £3781 per QALY. Cost-effectiveness declines at time horizons shorter than 10 years. Sensitivity analyses demonstrated that average system battery life had the largest impact on potential cost-effectiveness. CONCLUSION: Within the model limitations, these findings support the use of WiSE-CRT in indicated patients from an economic standpoint. However, improving battery technology should be prioritized to maximize cost-effectiveness in times when health services are under significant financial pressures.

Antiplatelet and Anti-Coagulation Therapy for Left-Sided Catheter Ablations: What Is beyond Atrial Fibrillation?

Aim: International guidelines on the use of anti-thrombotic therapies in left-sided ablations other than atrial fibrillation (AF) are lacking. The data regarding antiplatelet or anticoagulation strategies after catheter ablation (CA) procedures mainly derive from AF, whereas for the other arrhythmic substrates, the anti-thrombotic approach remains unclear. This survey aims to explore the current practices regarding antithrombotic management before, during, and after left-sided endocardial ablation, not including atrial fibrillation (AF), in patients without other indications for anti-thrombotic therapy. Material and Methods: Electrophysiologists were asked to answer a questionnaire containing questions on antiplatelet (APT) and anticoagulation therapy for the following left-sided procedures: accessory pathway (AP), atrial (AT), and ventricular tachycardia (VT) with and without structural heart disease (SHD). Results: We obtained 41 answers from 41 centers in 15 countries. For AP, before ablation, only four respondents (9.7%) used antiplatelets and two (4.9%) used anticoagulants. At discharge, APT therapy was prescribed by 22 respondents (53.7%), and oral anticoagulant therapy (OAC) only by one (2.4%). In patients with atrial tachycardia (AT), before ablation, APT prophylaxis was prescribed by only four respondents (9.7%) and OAC by eleven (26.8%). At discharge, APT was recommended by 12 respondents (29.3%) and OAC by 24 (58.5%). For VT without SHD, before CA, only six respondents (14.6%) suggested APT and three (7.3%) suggested OAC prophylaxis. At discharge, APT was recommended by fifteen respondents (36.6%) and OAC by five (12.2%). Regarding VT in SHD, before the procedure, eight respondents (19.5%) prescribed APT and five (12.2%) prescribed OAC prophylaxis. At discharge, the administration of anti-thrombotic therapy depended on the LV ejection fraction for eleven respondents (26.8%), on the procedure time for ten (24.4%), and on the radiofrequency time for four (9.8%), with a cut-off value from 1 to 30 min. Conclusions: Our survey indicates that the management of anti-thrombotic therapy surrounding left-sided endocardial ablation of patients without other indications for anti-thrombotic therapy is highly variable. Further studies are necessary to evaluate the safest approach to these procedures.

Leadless Pacing: Therapy, Challenges and Novelties.

Leadless pacing is a rapidly growing field. Initially designed to provide right ventricular pacing for those who were contraindicated for conventional devices, the technology is growing to explore the potential benefit of avoiding long-term transvenous leads in any patient who requires pacing. In this review, we first examine the safety and performance of leadless pacing devices. We then review the evidence for their use in special populations, such as patients with high risk of device infection, patients on haemodialysis, and patients with vasovagal syncope who represent a younger population who may wish to avoid transvenous pacing. We also summarise the evidence for leadless cardiac resynchronisation therapy and conduction system pacing and discuss the challenges of managing issues, such as system revisions, end of battery life and extractions. Finally, we discuss future directions in the field, such as completely leadless cardiac resynchronisation therapy-defibrillator devices and whether leadless pacing has the potential to become a first-line therapy in the near future.

The role of conduction system pacing in patients with atrial fibrillation.

Conduction system pacing (CSP) has emerged as a promising novel delivery method for Cardiac Resynchronisation Therapy (CRT), providing an alternative to conventional biventricular epicardial (BiV) pacing in indicated patients. Despite increasing popularity and widespread uptake, CSP has rarely been specifically examined in patients with atrial fibrillation (AF), a cohort which forms a significant proportion of the heart failure (HF) population. In this review, we first examine the mechanistic evidence for the importance of sinus rhythm (SR) in CSP by allowing adjustment of atrioventricular delays (AVD) to achieve the optimal electrical response, and thus, whether the efficacy of CSP may be significantly attenuated compared to conventional BiV pacing in the presence of AF. We next evaluate the largest clinical body of evidence in this field, related to patients receiving CSP following atrioventricular nodal ablation (AVNA) for AF. Finally, we discuss how future research may be designed to address the vital question of how effective CSP in AF patients is, and the potential hurdles we may face in delivering such studies.

Interatrial Septal Mass Secondary to Rosai-Dorfman Disease: A Rare Cause of Complete Heart Block.

Varying degrees of atrioventricular block can be associated with old age or a manifestation of an ischemic, metabolic, or infective pathology. In patients with no clear explanation, it is important to investigate secondary causes. Our case describes the first case of an adult with Rosai-Dorfman histiocytosis presenting with complete heart block. (Level of Difficulty: Advanced.).

Pacing interventions in non-responders to cardiac resynchronization therapy.

Non-responders to Cardiac Resynchronization Therapy (CRT) represent a high-risk, and difficult to treat population of heart failure patients. Studies have shown that these patients have a lower quality of life and reduced life expectancy compared to those who respond to CRT. Whilst the first-line treatment for dyssynchronous heart failure is "conventional" biventricular epicardial CRT, a range of novel pacing interventions have emerged as potential alternatives. This has raised the question whether these new treatments may be useful as a second-line pacing intervention for treating non-responders, or indeed, whether some patients may benefit from these as a first-line option. In this review, we will examine the current evidence for four pacing interventions in the context of treatment of conventional CRT non-responders: CRT optimization; multisite left ventricular pacing; left ventricular endocardial pacing and conduction system pacing.

Leadless Cardiac Pacing: New Horizons.

Since the introduction of transvenous cardiac pacing leads, pacemaker system design has remained similar for several decades. Progressive miniaturisation of electronic circuitry and batteries has enabled a smaller, single pacing unit comprising the intracardiac electrodes, generator and computer. This review explores the development of leadless pacing, the clinical trials comparing leadless to transvenous pacing in addition to the future developments of multi-chamber leadless pacing.

Effects of haemodynamically atrio-ventricular optimized His bundle pacing on heart failure symptoms and exercise capacity: the His Optimized Pacing Evaluated for Heart Failure (HOPE-HF) randomized, double-blind, cross-over trial.

AIMS: Excessive prolongation of PR interval impairs coupling of atrio-ventricular (AV) contraction, which reduces left ventricular pre-load and stroke volume, and worsens symptoms. His bundle pacing allows AV delay shortening while maintaining normal ventricular activation. HOPE-HF evaluated whether AV optimized His pacing is preferable to no-pacing, in a double-blind cross-over fashion, in patients with heart failure, left ventricular ejection fraction (LVEF) ≤40%, PR interval ≥200 ms and either QRS ≤140 ms or right bundle branch block. METHODS AND RESULTS: Patients had atrial and His bundle leads implanted (and an implantable cardioverter-defibrillator lead if clinically indicated) and were randomized to 6 months of pacing and 6 months of no-pacing utilizing a cross-over design. The primary outcome was peak oxygen uptake during symptom-limited exercise. Quality of life, LVEF and patients' holistic symptomatic preference between arms were secondary outcomes. Overall, 167 patients were randomized: 90% men, 69 ± 10 years, QRS duration 124 ± 26 ms, PR interval 249 ± 59 ms, LVEF 33 ± 9%. Neither peak oxygen uptake (+0.25 ml/kg/min, 95% confidence interval [CI] -0.23 to +0.73, p = 0.3) nor LVEF (+0.5%, 95% CI -0.7 to 1.6, p = 0.4) changed with pacing but Minnesota Living with Heart Failure quality of life improved significantly (-3.7, 95% CI -7.1 to -0.3, p = 0.03). Seventy-six percent of patients preferred His bundle pacing-on and 24% pacing-off (p < 0.0001). CONCLUSION: His bundle pacing did not increase peak oxygen uptake but, under double-blind conditions, significantly improved quality of life and was symptomatically preferred by the clear majority of patients. Ventricular pacing delivered via the His bundle did not adversely impact ventricular function during the 6 months.

Biventricular endocardial pacing and left bundle branch area pacing for cardiac resynchronization: Mechanistic insights from electrocardiographic imaging, acute hemodynamic response, and magnetic resonance imaging.

BACKGROUND: Biventricular endocardial pacing (BiV-endo) has demonstrated superior cardiac resynchronization compared to conventional biventricular epicardial pacing (BiV-epi). Left bundle branch area pacing (LBBAP) may also achieve effective cardiac resynchronization therapy (CRT). OBJECTIVE: The purpose of this study was to compare the acute electrical and hemodynamic effects of BiV-epi, BiV-endo, and LBBAP delivered from the LV endocardium and to assess how myocardial scar affects response. METHODS: Eleven patients with heart failure and indications for CRT underwent a temporary pacing study with electrocardiographic imaging (ECGi) and hemodynamic assessment. BiV-endo was delivered by stimulation of the left ventricular (LV) lateral wall, and LBBAP was delivered by stimulation of the LV septum, at the site of a Purkinje potential. LV activation time (LVAT-95), LV dyssynchrony index (LVDI), biventricular activation time (BIVAT-90), and biventricular dyssynchrony index (BIVDI) were calculated. Myocardial scar was assessed using magnetic resonance imaging (MRI). RESULTS: The protocol was completed in 10 patients. Compared to BiV-epi (LVAT-95: 79.2 ± 13.1 ms; LVDI: 26.6 ± 3.4 ms) LV resynchronization was superior during BiV-endo (LVAT-95: 48.5 ± 14.9 ms; P = .001; LVDI: 16.6 ± 6.4 ms; P = .002) and LBBAP (LVAT-95: 48.9 ± 12.5 ms; P = .001; LVDI: 15.3 ± 3.4 ms; P = .001). Biventricular resynchronization was similarly superior during BiV-endo and LBBAP vs BiV-epi (BIVAT-90 and BIVDI; P <.05). The rate of acute hemodynamic responders was higher during BiV-endo (90%) and LBBAP (70%) vs BiV-epi (50%). The benefits of LBBAP (but not BiV-endo) on LV resynchronization were attenuated when septal scar was present in a subset of 8 patients who underwent MRI. CONCLUSION: Our findings suggest superior electrical resynchronization and a higher proportion of acute hemodynamic responders during BiV-endo and LBBAP compared to BiV-epi. Electrical resynchronization was similar between BiV-endo and LBBAP; however, septal scar seemed to attenuate response to LBBAP.

Single-center experience of temporary-permanent pacemaker use in COVID-19 patients supported with veno-venous ECMO: A case series.

INTRODUCTION: In the first year of the COVID-19 pandemic, nine out of 129 patients (7%) developed life-threatening bradycardia episodes ultimately requiring a TPPM, whilst being supported with VV-ECMO for severe COVID-19 ARDS in our tertiary cardio-pulmonary failure center. ANALYSIS: All subjects had asystole due to sinus node dysfunction and experienced at least one episode involving cardiopulmonary resuscitation. Most bradycardic events were seen in the context of vagal hypersensitivity. Mean time from general ICU admission to TPPM insertion was 20.6 ± 8.9 days. One patient developed a large chest wall hematoma weeks after TPPM implantation, no other TPPM-related issues were observed. No patient required a long-term pacing system. Six-months survival rate was high (89%). CONCLUSION: These findings suggested that transient life-threatening sinus node disease is not uncommon in ECMO-dependent COVID-19 ARDS patients. TPPM with an active fixation lead is sometimes needed to facilitate ongoing ICU care, however, long-term permanent pacing was not required.

The role of guidance in delivering cardiac resynchronization therapy: A systematic review and network meta-analysis.

Background: Positioning the left ventricular lead at the optimal myocardial segment has been proposed to improve cardiac resynchronization therapy (CRT) response. Objectives: We performed a systematic review and network meta-analysis evaluating echocardiographic and clinical response delivered with different guidance modalities compared to conventional fluoroscopic positioning. Methods: Randomized trials with ≥6 months follow-up comparing any combination of imaging, electrical, hemodynamic, or fluoroscopic guidance were included. Imaging modalities were split whether one modality was used: cardiac magnetic resonance (CMR), speckle-tracking echocardiography (STE), single-photon emission computed tomography, cardiac computed tomography (CT), or a combination of these, defined as "multimodality imaging." Results: Twelve studies were included (n = 1864). Pair-wise meta-analysis resulted in significant odds of reduction in left ventricular end-systolic volume (LVESV) >15% (odds ratio [OR] 1.50, 95% confidence interval [CI] 1.05-2.13, P = .025) and absolute reduction in LVESV (standardized mean difference [SMD] -0.25, 95% CI -0.43 to -0.08, P = .005) with guidance. CMR (OR 55.3, 95% CI 4.7-656.9, P = .002), electrical (OR 17.0, 95% CI 2.9-100, P = .002), multimodality imaging (OR 4.47, 95% CI 1.36-14.7, P = .014), and hemodynamic guidance (OR 1.29-28.0, P = .02) were significant in reducing LVESV >15%. Only STE demonstrated a significant reduction in absolute LVESV (SMD -0.38, 95% CI -0.68 to -0.09, P = .011]. CMR had the highest probability of improving clinical response (OR 17.9, 95% CI 5.14-62.5, P < .001). Conclusion: Overall, guidance improves CRT outcomes. STE and multimodality imaging provided the most reliable evidence of efficacy. Wide CIs observed for results of CMR guidance suggest more powered studies are required before a clear ranking is possible.

Transvenous lead extraction in conduction system pacing.

Conduction System Pacing (CSP) delivered by His Bundle Pacing (HBP) or Left Bundle Pacing (LBP) are exciting novel interventions in the field of Cardiac Resynchronization Therapy (CRT). As the evidence base for CSP grows, the volume of implants worldwide is projected to rise significantly in the coming years. As such, physicians will be confronted with increasingly prevalent and vital issues arising in long-term follow up, including the management of infected, malfunctioning, or redundant CSP leads. Transvenous lead extraction (TLE) is the first-line option for removal of pacing leads when indicated in these circumstances. The evidence base for TLE in the context of CSP is still in its infancy. In this article, we first provide a brief overview of TLE. We then examine the data on the long-term performance of HBP leads. Next, we describe the features of the Medtronic Select Secure 3,830 lead, and how experience of TLE of this lead in the paediatric population has informed our practice. Finally, we review the current evidence for TLE in HBP and LBP, and discuss how future studies can address gaps in our current knowledge.

Leadless Left Bundle Branch Area Pacing in Cardiac Resynchronisation Therapy: Advances, Challenges and Future Directions.

Leadless left bundle branch area pacing (LBBAP) represents the merger of two rapidly progressing areas in the field of cardiac resynchronisation therapy (CRT). It combines the attractive concepts of pacing the native conduction system to allow more physiological activation of the myocardium than conventional biventricular pacing, with the potential added benefits of avoiding long-term complications associated with transvenous leads via leadless left ventricular endocardial pacing. This perspective article will first review the evidence for the efficacy of leadless pacing in CRT. We then summarise the procedural steps and pilot data for leadless LBBAP, followed by a discussion of the safety and efficacy of this novel technique. Finally, we will examine how further mechanistic evidence may shed light to which patients may benefit most from leadless LBBAP, and how improvements in current experience and technology could promote widespread uptake and expand current clinical indications.

Atrial pacing to suppress ventricular arrhythmias in the critically ill patients: a case report.

Background: Atrial and ventricular arrhythmias are common in the critically ill due to a variety of factors including sepsis, myocardial ischaemia, renal dysfunction, and electrolyte disturbances. Anti-arrhythmic medications can be useful to control arrhythmias but can result in bradycardia and haemodynamic compromise. A paced atrial rhythm alongside normal atrioventricular conduction can be helpful to treat bradycardia, prevent arrhythmias, and support cardiac output. Case summary: A 55-year-old gentleman with pseudomonas pneumonia, respiratory failure necessitating mechanical haemodynamic support, and subsequent coronary ischaemia presented to the intensive care unit. Paroxysms of atrial fibrillation and ventricular arrhythmias caused haemodynamic embarrassment and presented an ongoing clinical challenge as anti-arrhythmic medications resulted in bradycardia and Torsade de Pointes. Atrial pacing mediated intrinsic conduction via the His-Purkinje system inhibited ventricular ectopy and further arrhythmia breaking the tachycardia-bradycardia cycle; this stabilized the patient, facilitated ongoing intensive therapy unit care and promoted recovery. Conclusion: Atrial pacing mediated intrinsic conduction via the His-Purkinje system is an effective approach to suppress ventricular ectopy and sustained arrhythmias whilst protecting the patient from haemodynamically compromising bradycardia.

Dispersion of repolarization increases with cardiac resynchronization therapy and is associated with left ventricular reverse remodeling.

PURPOSE: Cardiac resynchronization therapy (CRT) reduces ventricular activation times and electrical dyssynchrony, however the effect on repolarization is unclear. In this study, we sought to investigate the effect of CRT and left ventricular (LV) remodeling on dispersion of repolarization using electrocardiographic imaging (ECGi). METHODS: 11 patients with heart failure and electrical dyssynchrony underwent ECGi 1-day and 6-months post CRT. Reconstructed epicardial electrograms were used to create maps of activation time, repolarization time (RT) and activation recovery intervals (ARI) and calculate measures of RT, ARI and their dispersion. ARI was corrected for heart rate (cARI). RESULTS: Compared to baseline rhythm, LV cARI dispersion was significantly higher at 6 months (28.2 ± 7.7 vs 36.4 ± 7.2 ms; P = 0.03) but not after 1 day (28.2 ± 7.7 vs 34.4 ± 6.8 ms; P = 0.12). There were no significant differences from baseline to CRT for mean LV cARI or RT metrics. Significant LV remodeling (>15% reduction in end-systolic volume) was an independent predictor of increase in LV cARI dispersion (P = 0.04) and there was a moderate correlation between the degree of LV remodeling and the relative increase in LV cARI dispersion (R = -0.49) though this was not statistically significant (P = 0.12). CONCLUSION: CRT increases LV cARI dispersion, but this change was not fully apparent until 6 months post implant. The effects of CRT on LV cARI dispersion appeared to be dependent on LV reverse remodeling, which is in keeping with evidence that the risk of ventricular arrhythmia after CRT is higher in non-responders compared to responders.

Leadless left ventricular endocardial pacing for cardiac resynchronization therapy: A systematic review and meta-analysis.

BACKGROUND: Leadless left ventricular (LV) endocardial pacing to achieve cardiac resynchronization therapy (CRT) is a novel procedure for treatment of patients with dyssynchronous heart failure. Current evidence is limited to observational studies with small patient numbers. OBJECTIVE: The purpose of this systematic review and meta-analysis was to assess the safety and efficacy of leadless LV endocardial pacing. METHODS: A literature search was conducted through PubMed, EMBASE, and Cochrane databases. Mean differences (MDs) in New York Heart Association (NYHA) functional class and LV ejection fraction (LVEF) from baseline to 6 months postprocedure were combined using a random effects model. Heterogeneity was evaluated using the Cochrane Q test, I2, meta-regression, and sensitivity analysis. Funnel plots were constructed to detect publication bias. RESULTS: Five studies with 181 patients were included in the final analysis. Procedural success rate was 90.6%. Clinical response rate was 63%, with mean improvement in NYHA functional class of 0.43 (MD -0.43; 95% confidence interval [CI] -0.76 to -0.1; P = .01), with high heterogeneity (P <.001; I2 = 81.1%). There was a mean increase in LVEF of 6.3% (MD 6.3; 95% CI 4.35-8.19; P <.001, with low heterogeneity (P = 0.84; I2 <0.001%). The echocardiographic response rate was 54%. Procedure-related complication and mortality rates were 23.8% and 2.8%, respectively. CONCLUSION: The efficacy of leadless LV endocardial pacing for CRT supports its use as a second-line therapy in patients in whom standard CRT is not possible or has been ineffective. Improvements in safety profile will facilitate widespread uptake in the treatment of these patients.

Takotsubo syndrome and complete heart block, which came first? A case report.

BACKGROUND: In 2018, the European Society of Cardiology published two consensus documents on takotsubo syndrome (TTS), which include the current consensus on nomenclature, diagnosis, management, and complications. However, little is mentioned on the association with complete heart block (CHB), except that 'AV block [occurs in] 2.9% of cases'. Complete heart block is a recognized rare association of TTS, but causation is often unclear. Does CHB trigger TTS or vice-versa? Here, we present a case of TTS associated with CHB. CASE SUMMARY: An 89-year-old woman presented with a transient loss of consciousness, acute chest pain, and dyspnoea. A few days prior to this her daughter died suddenly of a myocardial infarction. On presentation, troponin levels were elevated, the electrocardiogram showed CHB with a broad QRS and an echo showed apical akinesis and ballooning. Angiographic investigation excluded significant coronary artery disease. A dual-chamber pacemaker was implanted after a brief period of temporary pacing. Ventricular function normalized during follow-up and her underlying rhythm remained CHB. DISCUSSION: Takotsubo syndrome may be triggered by both emotional and physical stressors. Complete heart block is recognized association, but causation is often unclear. In our case, a clear emotional trigger was identified suggesting the TTS may have precipitated CHB not vice versa.

The long-term outcomes of cardiac implantable electronic devices implanted via the femoral route.

BACKGROUND: Conventional superior access for cardiac implantable electronic devices (CIEDs) is not always possible and femoral CIEDs (F-CIED) are an alternative option when leadless systems are not suitable. The long-term outcomes and extraction experiences with F-CIEDs, in particular complex F-CIED (ICD/CRT devices), remain poorly understood. METHODS: Patients referred for F-CIEDs implantation between 2002 and 2019 at two tertiary centers were included. Early complications were defined as ≤30 days following implant and late complications >30 days. RESULTS: Thirty-one patients (66% male; age 56 ± 20 years; 35% [11] patients with congenital heart disease) were implanted with F-CIEDs (10 ICD/CRT and 21 pacemakers). Early complications were observed in 6.5% of patients: two lead displacements. Late complications at 6.8 ± 4.4 years occurred in 29.0% of patients. This was higher with complex F-CIED compared to simple F-CIED (60.0% vs. 14.3%, p = .02). Late complications were predominantly generator site related (n = 8, 25.8%) including seven infections/erosions and one generator migration. Eight femoral generators and 14 leads (median duration in situ seven [range 6-11] years) were extracted without complication. CONCLUSIONS: Procedural success with F-CIEDs is high with clinically acceptable early complication rates. There is a notable risk of late complications, particularly involving the generator site of complex devices following repeat femoral procedures. Extraction of chronic F-CIED in experienced centers is feasible and safe.