Pocket Revision Research Articles

His bundle pacing implantation in octogenarian patients: a substudy of the PACE-CONDUCT trial

Abstract Background His bundle pacing (HBP) is gaining recognition as a valuable alternative for the management of various cardiac conduction disorders. This substudy, conducted within the framework of the PACE-CONDUCT trial, investigates the outcomes of HBP implantation in patients aged 80 years and older, comparing them with a younger cohort. Methods We examined a total of 61 consecutive patients who underwent HBP implantation, utilizing DDD pacemakers, CRT-P, or CRT-D devices, during the years 2021 to 2023. Patients were categorized into two subgroups: those aged younger than 80 years and those aged 80 years or older. The mean age of the entire cohort was 73 years, spanning from 51 to 86 years, with 15 patients (comprising 24.6% of the total) falling into the octogenarian category. His bundle threshold was assessed on the day of implantation, one day post-implantation, and four weeks post-implantation. All HBP implantations were deemed successful, incorporating both selective and non-selective His bundle pacing. Complications were classified as major (necessitating lead or pocket revision) or minor (requiring no revision). Threshold values were converted to volts per milliseconds (volts x milliseconds) for statistical analysis, conducted with IBM SPSS Statistics 29.0. Results Initial analysis revealed a consistent success rate of HBP implantation across all patients, with no discernible differences between the two age groups. Threshold measurements at the day of implantation and after one day indicated no differences between the younger and the older group. However, at the four-week mark, a statistically significant lower threshold of His bundle pacing was observed in the octogenarian group (one-sided p-value 0.028), suggesting a faster stabilization to the chronic threshold of the active fixation His Bundle lead. The comparison of major and minor complications between the age groups, conducted using chi-square tests, revealed no age-related discrepancies. Conclusions This substudy of the PACE-CONDUCT trial underscores the feasibility and safety of His bundle pacing implantation in octogenarian patients, comparable to their younger counterparts. While no initial threshold variations are observed, the octogenarian group demonstrated improved His bundle pacing thresholds approximately four weeks post-implantation. Importantly, the study revealed no heightened complication risk associated with advanced age, affirming that very old patients aged 80 or older can derive the benefits of His bundle pacing without increased complication rates. Given the relatively modest patient cohort in this study, further investigations are warranted to validate and extend these findings.T-tests and Chi square tests

Clinical impact of capsulectomy during cardiac implantable electronic device generator replacement: a prospective randomized trial.

The avascular capsule around the generator of the cardiac implantable electronic device (CIED) could be susceptible to bacterial colonization and source of infection. Capsulectomy during CIED generator replacement may be beneficial in preventing device infection, but there is a lack of evidence. This prospective randomized trial, conducted from December 2013 to December 2019, included 195 patients divided equally into two groups. In the intervention group (n = 97), capsule removal was performed on the floor of the pocket, while it was not performed in the control group (n = 98). In both groups, swab culture was performed in the pocket. The primary outcome was the occurrence of device infection requiring pocket revision. A total of 195 patients were included (mean age 70.2 ± 13.6years, 55.4% women), with an average follow-up period of 54.3 ± 28.9months. Among 182 patients undergoing microbiological cultures of pockets, 19 (10.4%) were confirmed positive, and Staphylococcus species were identified most frequently. The primary outcome occurred in 4 (2.1%), and there was no significant difference between the two groups (3.1% vs. 1.0%, p = 0.606). Hematoma has occurred in 10 patients (3.1% vs. 7.1%, p = 0.338), one of them required wound revision. In multivariable analysis, the occurrence of hematoma was the only independent risk factor associated with device infection (HR 13.6, 95% CI 1.02-181.15, p = 0.048). In this long-term prospective study, capsulectomy during the replacement of the generator did not reduce the incidence of device infection. There was no association between bacterial colonization in the capsule around the generator and CIED infection.

Measures to Prevent Infection in Cardiac Implantable Electronic Device Replacements or Upgrades.

Cardiac implantable electronic device (CIED) infections represent one of the most threatening complications associated with device implantation, due to an increase in morbidity and mortality rates, as well as healthcare costs. Besides, it is important to highlight that when compared to the initial implantation of a device, the risks associated with procedures like generator changes, lead and pocket revisions, or device upgrades double. Consequently, to address this issue, various scoring systems, like the PADIT (Prior Procedures, Age, Depressed Renal Function, Immunocompromised Status, Type of Procedure), the RI-AIAC (Ricerca Sulle Infezioni Associate a ImpiAnto o Sostituzione di CIED), and the Shariff score, along with predictive models, have been developed to identify patients at a greater risk of infection. Moreover, several interventions have been assessed to evaluate their role in infection prevention ranging from improving skin preparation and surgical techniques to considering alternative strategies such as the subcutaneous Implantable Cardioverter-Defibrillator (ICD). Methods like antimicrobial prophylaxis, pocket irrigation, chlorhexidine gluconate pocket lavage, capsulectomy, and the use of antibacterial envelopes have been also explored as preventive measures. In this review, we provide a comprehensive assessment of CIED infections in patients undergoing repeat procedures and the strategies designed to reduce the risk of these infections.

The effect of body mass index on complications in cardiac implantable electronic device surgery.

Cardiac implantable electronic device (CIED) procedures are prone to complications. In our study, we investigated the effect of body mass index (BMI) on CIED-related complications. 1676 patients who had undergone CIED surgery (de novo implantation, system upgrade, generator change, pocket revision or lead replacement) at two heart centers in Turkey and met the study criteria were included in our study. For analysis of primary and secondary endpoints, patients were classified as non-obese (BMI<25kg/m2 ), overweight (25 ≤ BMI<30kg/m2 ), and obese (BMI ≥ 30kg/m2 ). The primary endpoint was accepted as cumulative events, including the composite of clinically significant hematoma (CSH), pericardial effusion or tamponade, pneumothorax, and infection related to the device system. Secondary outcomes included each component of cumulative events. The rate of cumulative events, defined as primary outcome, was higher in the obese patient group, and we found a significant difference between the groups (3.0%, 4.3%, 8.9%, p=.001). CSH and pneumothorax rates were significantly higher in the obese patient group (0.3%, 0.9%, 1.9%, p=.04; 1.0%, 1.4%, 3.3%, p=.04, respectively). According to our multivariate model analysis; gender (OR:1.882, 95%CI:1.156-3.064, p=.01), hypertension (OR:4.768, 95%CI:2.470-9.204, p<.001), BMI (OR:1.069, 95%CI:1.012-1.129, p=.01) were independent predictors of cumulative events rates. Periprocedural complications associated with CIED (especially hematoma and pneumothorax) are more common in the group with high BMI.

Aging and cardiac implantable electronic device complications: is the procedure safe in older patients?

In this study, we investigated whether there is a higher incidence of cardiac implantable electronic devices (CIED) procedures related complications in older (≥ 75years) than in younger (< 75years) patients. This retrospective cohort study enrolled patients who had undergone CIED procedures (de novo implantation, system upgrade, generator substitution, pocket revision or lead replacement) at two heart centers in Turkey between January 2011 and May 2023. The primary composite endpoint included clinically significant hematoma (CSH), pericardial effusion or tamponade, pneumothorax, and infection related to the device system. Secondary outcomes included each component of the composite end point. The overall sample included 1923 patients (1419 < 75years and 504 aged ≥ 75years). There was no difference between the groups in terms of cumulative events defined as primary outcome (3.5% vs. 4.4%, p = 0.393). Infection related to device system was significantly higher in the ≥ 75 age group (1.8% vs. 3.4%, p = 0.034). There was no significant difference between the groups in terms of clinically significant hematoma and pneumothorax (0.7% vs. 0.4%, p = 0.451, 1.4% vs. 1.0%, p = 0.477, respectively). In multivariate model analysis, no association was found between age ≥ 75years and infection related to the device system. Infection rates were relatively higher in the patient group aged ≥ 75years. This patient group should be evaluated more carefully in terms of infection development before and after the procedure.

Topical Tranexamic Acid in Primary Breast Augmentation Surgery: Short- and Long-term Outcomes.

Breast augmentation mammaplasty (BAM) remains the most popular cosmetic procedure done worldwide. Bleeding in this procedure increases the chance of capsular contracture. Tranexamic acid (TXA), an antifibrinolytic, has been widely used by other surgical specialties to reduce bleeding. We aimed to evaluate the use of TXA in BAM surgery. This was a single-surgeon case series of all patients who underwent primary BAM from March 2017 to March 2018 and received topical TXA spray to the implant pocket before implant insertion. Early postoperative complications and long-term outcomes, such as capsular contracture and revisional surgery, were recorded and described. Two hundred and eighty-eight patients were included in the study with an overall complication rate of 2.8% over 5 years. No patients had postoperative bleeding or hematoma formation. One patient had a seroma, managed with ultrasound drainage. Complications requiring reoperation included rippling (3, 1.0%), pocket revision (2, 0.7%), capsule contracture (1, 0.3%) and rupture (1, 0.3%). This study highlights the safety and potential benefits of the use of topical TXA in breast augmentation, with low bleeding and capsular contracture rates.

Safety of epinephrine-containing local anaesthesia in CIED implantations

Abstract Funding Acknowledgements Type of funding sources: None. Background Cardiac implantable electronic devices (CIED) are common. Permanent pacemaker implantations can improve quality of life of patients with sick-sinus syndrome and prolong survival in those with infranodal high-grade AV block. Nonetheless, pocket haemathoma can be problematic post CIED implantation, especially with the increasing use of oral anticoagulants and antiplatelet agents (especially P2Y12 inhibitors) in the at-risk population. The use of epinephrine in local anaesthetic is common in UK but remains controvesial with 2021 EHRA consensus statement recommending its avoidance(1). Aim To compare the rate of pocket haemathoma and subsequent haemathoma drainage and pocket revisions in CIED patients who have received epinephrine-containing local anaesthetia versus local anesthesia without epinephrine. Methods Retrospective, observational studies across a disctrict general hospital and tertiary cardiology hospital, involving a total of 377 consecutive CIED patients over the course of 2021 - 2022. Patients' demographics, comorbidities, peri-procedural medication use and complication events were retrived from electronic data base. Types of local anaesthesia were recorded. Results and Outcomes Out of 377 patients, 184 patients received 1% epinephrine-containing local anaesthesia (Group 1) and 193 patients received plain local anesthesia only (Group 2). In terms of baseline demographics (age and gender distribution), associated comorbidities (treated hypertension, diabetes type 2, ischaemic heart disease, hypercholesterolemia, smoker) were not statistically different between both groups. Number of leads implanted (DDD vs VVI vs ILR) were not statistically different (26.6% DDD pacemaker and 65.8% VVI pacemaker in Group 1 versus 34.8% DDD and 57.0% VVI in Group 2, p=0.143). Periprocedural usage of oral anticoagulations (38.6% vs 30.5%,p=0.102) and single or dual antiplatelet agents (31.5% vs 29.0%, p=0.796) were not different between both groups. Overall complication rates were low and not statistically different between both groups: 4.35% in Group 1 versus 6.74% in Group2. Only 1 patient received epinephine-containing local anesthesia experienced pocket haemathoma against 6 patients who received plain local anaesthsia (0.543% vs 3.11%,p=0.122). No patients require evacuation of haemathoma, drainage or subsequent pocket revision (p= 1.0). Summary: The results of this retrospective observational study demonstrated that 1% epinephrine-containing local anesthesia for CIED implantation is not associated with increased risk of pocket haemathoma, no increased risk of haemathoma evacuation, drainage or pocket revision. This is despite peri-procedural anticoagulation or antiplatelet use exceeding 70%. This "real-life" result is incongruent with the published MAITRE study which formed the basis for the 2021 EHRA expert consensus statement. Recommendation surrounding epinephrine-containing local anaesthesia in CIED implantation may need to be reviewed.

Clinical impact of capsulectomy during cardiac implantable electronic device generator replacement: a prospective randomized trial

Abstract Funding Acknowledgements Type of funding sources: None. Background The avascular capsule around the generator of cardiac implantable electronic device (CIED) could be susceptible for bacterial colonization and source of infection. Capsulectomy during CIED generator replacement may be beneficial in preventing device infection, but there is a lack of evidence. Methods This study was a prospective randomized trial. Patients receiving generator replacement were enrolled from December 2013 to December 2019. A total of 195 patients were 1:1 randomly assigned, for patients in the intervention group (n=97), capsule removal was performed on the floor of the pocket during generator replacement but not for patients in the control group (n=98). In both groups, microbiological culture was performed in the pocket. The primary outcome was the occurrence of device infection requiring pocket revision. Results Of the 195 patients included (mean age 70.2 ± 13.6years, 55.4% women), 54 (27.7%) included additional lead revision, 19 (9.7%) had biventricular device. Among 182 patients undergoing microbiological cultures of pockets, 19 (10.4%) were confirmed positive, 4 S. epidermidis (21.1%) and 3 S. aureus (15.8%) were identified most frequently. The primary outcome occurred in 4 (2.1%), and there was no significant difference between the two groups (Intervention group 3 (3.1%) vs Control group 1 (1.0%), p=0.606). Hematoma was occurred in 10 patients (Intervention group 3 (3.1%) vs Control group 7 (7.1%), p=0.338), one of them required wound revision. In multivariable analysis, the occurrence of hematoma was the only independent risk factor associated with device infection. (HR 13.6, 95% CI 1.02-181.15, p=0.048). Conclusion In this study, capsulectomy during replacement of generator did not reduce the incidence of device infection. There was no association between bacterial colonization in the capsule around the generator and CIED infection.

Role of the implantable loop recorder in clinical practice: insights on indications, diagnostic yield and therapeutic implications from a single, high volume, tertiary care centre experience

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Besides the established class I indication for the evaluation of patients with recurrent syncope of uncertain origin, implantable loop recorders (ILRs) have been increasingly used for other diagnostic purposes (e.g. detection of atrial fibrillation (AF) following cryptogenic stroke). Purpose To describe the main indications to ILR and to investigate procedural parameters, outcomes and diagnostic yield of ILR in a single, high-volume tertiary care centre. Methods All patients undergoing ILR implantation between November 2007 and April 2022 were consecutively enrolled in this study. Clinical characteristics of patients, procedural data and outcomes were collected. The indications to ILR implantation were divided into four categories: 1) AF detection in patients with recent cryptogenic stroke or peripheral thromboembolism [CRYSP], 2) recurrent syncope of uncertain origin [RSUO], 3) monitoring of ventricular arrhythmic events [VAE] in patients with predisposing cardiomyopathy/channelopathy, 4) monitoring of AF burden or relapse [AFB]. The main endpoint of the study was the diagnostic yield (number of definitive diagnoses made) and the time to diagnosis following ILR implantation. The occurrence of acute or subacute complications was used as a secondary safety endpoint. Results Overall, 1442 patients underwent ILR implantation (mean age 65 years, 43% female). The two main indications to ILR were AF detection following CRYSP and RSUO (42% and 34% of all implantations respectively, table 1). The commonest site of implantation was the left parasternal position (902 patients, 63%), median procedural time was 20 minutes (IQR 15-25). During a median follow-up of 397 days (134-1094), infections requiring ILR extraction or pocket revision occurred in 13 patients (0.9%). A definitive diagnosis was achieved in 500 (35%) patients after a median time of 206 days (IQR 60-533) [table 1 shows details and action taken following diagnosis for each indication subgroup]. At multivariable analysis, age and PR interval duration were significantly associated with the need for PM/ICD implantation among patients receiving ILR for RSUO whilst age was associated with AF detection among those with CRYSP (table 2). Conclusions In this cohort of patients use of ILR was associated with a good diagnostic yield regardless of the initial indication, triggered timely therapeutic actions and was overall safe.

An alternative to transvenous lead extraction in selected patients with CIED infections: a retrospective outcome study

Abstract Funding Acknowledgements Type of funding sources: None. Background Cardiac implantable electronic devices (CIED) implants are rising in an older, more co-morbid population [1]. The prevalence of CIED infection ranges from 1-4% [2, 3]. Whilst complete extraction of all transvenous hardware is recommended for infected, eroded or pre-eroding CIEDs [4], this approach is not without risk [5] and may be unacceptable to some patients [6]. Long term data on a more conservative strategy is lacking. We report on our experience of conservative management with pocket revision as a primary strategy in carefully selected patients. Method A retrospective review of all CIED revision procedures at a large tertiary centre, over a 7-year period was undertaken with a mean follow up of 39 months. Results 86 patients underwent 96 revision procedures. 7 patients required further revisions and 13 went on to undergo CIED extraction by the end of follow up. There was no in hospital mortality and all patients were alive at 30 days. Overall mortality at 12 months was 8.1% (7 deaths), increasing to 24.4% (21 deaths) at end of follow up. Conclusion Our data provides important outcome information on an alternative strategy to lead extraction in carefully selected patients where the risk of extraction is perceived to be unacceptable. The absence of systemic infection appears to predict better outcomes than previously reported, and over two-thirds of patients remained complication free at 12 months.

Replacement Adaptor 09106 for patients with a dynamic graciloplasty or patients with sacral neuromodulation and abdominal implantable pulse generators: a retrospective, single centre, Stage 2a/2b development IDEAL case series.

Due to the introduction of a new implantable pulse generator (IPG), the Interstim II, patients with either a dynamic graciloplasty or an abdominally placed IPG for sacral neuromodulation could not undergo surgery to replace their IPG in the case of end of battery life. For these patients, the Medtronic Replacement Adaptor 09106 was created. This retrospective case series aims to study safety and feasibility of the Medtronic Replacement Adaptor 09106 in patients with abdominally placed IPGs. Seventeen patients (11 women, six men) received a replacement adaptor with a follow-up of 6months. Outcome measures consisted of a bowel habit diary. Adverse events were classified using the Clavien-Dindo classification. Outcome measures in the bowel habit diaries after replacement (feasibility) did not differ significantly from outcome measures before replacement. Adverse events occurred in four out of 17 patients (24%): two patients initially showed pocket site pain (Clavien-Dindo Grade I), which resolved without intervention. One patient suffered from poor wound closure (Clavien-Dindo Grade II) and one patient had persisting pocket pain (Clavien-Dindo Grade IIIa) for which a pocket revision was performed. Statistical analyses were performed making paired comparisons using a Wilcoxon signed rank test. The Medtronic Replacement Adaptor 09106 is a valuable option for patients with dynamic graciloplasty or sacral neuromodulation and abdominal IPG and has complication rates similar to replacement of the Interstim without Replacement Adaptor 09106.

A Comparative Study of Secondary Procedures after Subpectoral and Prepectoral Single-Stage Implant-Based Breast Reconstruction.

Implant-based breast reconstruction (IBR) is the most commonly used procedure to reconstruct the breast after mastectomy. The advantages and disadvantages of subpectoral versus prepectoral implant placement remain a matter of debate. This study compares the need for secondary aesthetic procedures between prepectoral and subpectoral IBR. This is a retrospective cohort study of consecutive patients who underwent subpectoral or prepectoral IBR between 2015 and 2018 under a single surgeon at a tertiary breast unit. The primary endpoint was the number of secondary procedures performed to improve the aesthetic outcome. Secondary endpoints included the number of secondary procedures during the first year. A total of 271 one-stage IBRs were performed (subpectoral, n = 128 in 74 patients; prepectoral, n = 143 in 84 patients). Overall, more patients required secondary procedures in the subpectoral group (36.5% versus 19%; P = 0.014), although through longer follow-up. The most common procedures were pocket revision and implant exchange [11.7% versus 3.5% ( P = 0.010); 11.7% versus 4.2% ( P = 0.021)], whereas fat grafting was similar between the two groups (46% versus 40.5%; P = 0.777). When adjusted for follow-up time, there was no significant difference in the number of secondary procedures undertaken in the subpectoral versus the prepectoral group (21% versus 16%, respectively; P = 0.288) at 1 year. The requirement for secondary procedures at 1 year was not different between groups. The need for fat grafting was not increased following prepectoral IBR. Therapeutic, III.

P12 SUBCUTANEOUS IMPLANTABLE CARDIOVERTER–DEFIBRILLATOR AFTER TRANSVENOUS LEAD EXTRACTION: SAFETY, EFFICACY AND OUTCOME

Abstract Background Subcutaneous implantable cardioverter defibrillator (S–ICD) is a suitable alternative for trans–venous–ICD (TV–ICD) patients underwent transvenous lead extraction (TLE) for any reason, but limited data are available about outcome of s–ICD patients implanted after TLE. Methods Thirty–six consecutive patients underwent TLE of TV–ICD and subsequent S–ICD implantation in our center were included in this prospective single–center observational study (72.2% male, median age 52 years–old). Results During a median follow-up of 31 months, 3 patients (8.3%) experienced appropriate therapy and 7 patients (19.4%) experienced complications including innapropriate therapy (IAT) (n = 4; 11.1%), pulse generator decubitus with no evidence of infection (n = 2; 5.5%) and ineffective therapy (n = 1; 2.7%). Reasons of IAT were: T–wave oversensing in one patient and extracardiac signals in the remaining 3 patients. Of note, 2 patients who experienced IAT had a left–ventricular assist device (LVAD) for refractory heart failure (HF). Premature device explantation and TV–ICD re–implantation occurred in 4 patients (11%) for pulse generator decubitus despite surgical pocket revisions (n = 2), for recurrent IAT despite reprogramming (n = 1) and ineffective therapy during arrhythmic storm (n = 1). Eight patients (22.2%) died, 3 patients (9%) underwent LVAD implantation due refractory HF during follow-up. Six patients died because of refractory HF, 1 patient died due to intracerebral hemorrhage and 1 due to sarcoidosis. There were no documented deaths associated with the procedure or the S–ICD system itself. No patient had the device removed because of a perceived need for antitachycardia pacing (ATP) or the necessity of pacing or cardiac resynchronization therapy despite 9 patients (25%) after TLE of a two–chamber ICD and one patient (3%) after TLE of a CRT–D. Univariate predictors of death included hypertension (HR 22.72; p = 0.02), diabetes (HR 10.64; p = 0.001), ischemic heart disease (HR 5.92; p = 0.01) and NYHA class &amp;gt; = II (p = 0.04). We did not observed any predictors for complications including IATs and device-related complications requiring surgical revision. Conclusions S–ICD implantaion after TLE of TV–ICD is safy and effective. Baseline clinical characterisctics including ischemic heart disease, diabetes, hypertension and NYHA class &amp;gt; = II are associated with worse survival.

Risk profiles and outcomes of patients receiving antibacterial cardiovascular implantable electronic device envelopes: A retrospective analysis.

BACKGROUNDCardiovascular implantable electronic devices (CIEDs) are implanted in an increasing number of patients each year, which has led to an increase in the risk of CIED infection. Antibacterial CIED envelopes locally deliver antibiotics to the implant site over a short-term period and have been shown to reduce the risk of implant site infection. These envelopes are derived from either biologic or non-biologic materials. There is a paucity of data examining patient risk profiles and outcomes from using these envelope materials in the clinical setting and comparing these results to patients receiving no envelope with their CIED implantation.AIMTo evaluate risk profiles and outcomes of patients who underwent CIED procedures with an antibacterial envelope or no envelope.METHODSAfter obtaining Internal Review Board approval, the records of consecutive patients who underwent a CIED implantation procedure by a single physician between March 2017 and December 2019 were retrospectively collected from our hospital. A total of 248 patients within this period were identified and reviewed through 12 mo of follow up. The CIED procedures used either no envelope (n = 57), a biologic envelope (CanGaroo®, Aziyo Biologics) that was pre-hydrated by the physician with vancomycin and gentamicin (n = 89), or a non-biologic envelope (Tyrx™, Medtronic) that was coated with a resorbable polymer containing the drug substances rifampin and minocycline by the manufacturer (n = 102). Patient selection for receiving either no envelope or an envelope (and which envelope to use) was determined by the treating physician. Statistical analyses were performed between the 3 groups (CanGaroo, Tyrx, and no envelope), and also between the No Envelope and Any Envelope groups by an independent, experienced biostatistician. RESULTSOn average, patients who received any envelope (biologic or non-biologic) were younger (70.7 ± 14.0 vs 74.9 ± 10.6, P = 0.017), had a greater number of infection risk factors (81.2% vs 49.1%, P < 0.001), received more high-powered devices (37.2% vs 5.8%, P = 0.004), and were undergoing more reoperative procedures (47.1% vs 0.0%, P < 0.001) than patients who received no envelope. Between the two envelopes, biologic envelopes tended to be used more often in higher risk patients (84.3% vs 78.4%) and reoperative procedures (62.9% vs 33.3%) than non-biologic envelopes. The rate of CIED implant site pocket infection was low (any envelope 0.5% vs no envelope 0.0%) and was statistically equivalent between the two envelope groups. Other reported adverse events (lead dislodgement, lead or pocket revision, device migration or erosion, twiddler’s syndrome, and erythema/fever) were low and statistically equivalent between groups (biologic 2.2%, non-biologic 3.9%, no envelope 1.8%). CONCLUSIONCIED infection rates for biologic and non-biologic antibacterial envelopes are similar. Antibacterial envelopes may benefit patients who are higher risk for infection, however additional studies are warranted to confirm this.

Long-Term Implications of Pacemaker Insertion in Younger Adults: A Single Centre Experience

The long-term implications of pacemaker insertion in younger adults are poorly described in the literature. We performed a retrospective analysis of consecutive younger adult patients (18-50 yrs) undergoing pacemaker implantation at a quaternary hospital between 1986-2020. Defibrillators and cardiac resynchronisation therapy devices were excluded. All clinical records, pacemaker checks and echocardiograms were reviewed. Eighty-one (81) patients (median age 41.0 yrs IQR=35-47.0, 53% male) underwent pacemaker implantation. Indications were complete heart block (41%), sinus node dysfunction (33%), high grade AV block (11%) and tachycardia-bradycardia syndrome (7%). During a median 7.9 (IQR=1.1-14.9) years follow-up, nine patients (11%) developed 13 late device-related complications (generator or lead malfunction requiring reoperation [n=11], device infection [n=1] and pocket revision [n=1]). Five (5) of these patients were <40 years old at time of pacemaker insertion. At long-term follow-up, a further nine patients (11%) experienced pacemaker-related morbidity from inadequate lead performance managed with device reprogramming. Sustained ventricular tachycardia was detected in two patients (2%). Deterioration in ventricular function (LVEF decline >10%) was observed in 14 patients (17%) and seven of these patients required subsequent biventricular upgrade. Furthermore, four patients (5%) developed new tricuspid regurgitation (>moderate-severe). Of 69 patients with available long-term pacing data, minimal pacemaker utilisation (pacing <5% at all checks) was observed in 13 (19%) patients. Pacemaker insertion in younger adults has significant long-term implications. Clinicians should carefully consider pacemaker insertion in this cohort given risk of device-related complications, potential for device under-utilisation and issues related to lead longevity. In addition, patients require close follow-up for development of structural abnormalities and arrhythmias.

Working on the dirty side-the ipsilateral subclavian access for temporary pacing after lead extraction.

BackgroundTemporary pacing is necessary in pacemaker‐dependent patients after transvenous lead extraction (TLE) for cardiac implantable electronic device infection. In case of unavailability of other accesses, we propose to use the ipsilateral subclavian access (ISA) combined with a standard permanent active fixation lead for the temporary pacemaker and present preliminary data.MethodsWe consecutively enrolled patients undergoing TLE who received a temporary pacemaker using the ISA between August 2016 and April 2020 at our centre.ResultsDuring the observation period, 36 patients undergoing TLE for pocket infection (72.2%), endocarditis (25.0%) or other causes received a temporary pacemaker over the ISA. Their mean age was 77.0 ± 10.7 years, and 13.9% were female. Complete TLE was achieved in 94.4%. There were no major periprocedural complications. Intra‐hospital mortality was 11.1%. Pocket revision was performed in 19.4%. During long‐term follow‐up (23 ± 13 months), 8.3% had a relapse of local pocket infection and 2.8% needed rehospitalization for reintervention.ConclusionsTemporary pacing using a standard permanent active fixation lead using the ISA is a convenient alternative to conventional venous accesses. However, risks of implanting a lead into a previously infected area have to be taken into account.

An Alternative to Transvenous Lead Extraction in Selected Patients with CIED Infections—A Retrospective Outcome Study

Cardiac implantable electronic device (CIED) implants are rising in an older, more co-morbid population. The prevalence of CIED infection ranges from 1–4%. Whilst complete extraction of all transvenous hardware is recommended for infected, eroded, or pre-eroding CIEDs, this approach is not without risk and may be unacceptable to some patients. Long-term data on a more conservative strategy is lacking. We report on our experience of conservative management with pocket revision as a primary strategy in carefully selected patients. Method: A retrospective review of all CIED revision procedures was undertaken at a large tertiary center, over a 7-year period, with a mean follow-up timeframe of 39 months. Results: A total of 86 patients underwent 96 revision procedures; 7 patients required further revisions and 13 went on to undergo CIED extraction by the end of the follow-up period. The overall rate of mortality at 12 months was 8.1%, increasing to 24.4% at the end of the follow-up period. Conclusion: Our data provide important outcome information on an alternative strategy to lead extraction in carefully selected patients where the risk of extraction is perceived to be unacceptable. The absence of systemic infection appears to predict better outcomes than previously reported, and over two-thirds of patients remained complication-free at 12 months.

598 Are risk scores sufficient to stratify patients undergoing lead extraction? A single-centre analysis

Abstract Aims Device implantation is growing exponentially, as well as associated infections, ranging from isolated pocket erosion to endocarditis and bacteraemia, all worsening the prognosis of patients with frailty and comorbidity. Transvenous lead extraction (TLE) can resolve the complications, although a 1-year mortality risk of up to 25% is reported; despite higher health costs, prolonged hospitalization, and poor quality of life, strategies for predicting increased infection risk and reduced infection incidence are yet missing. Currently applied clinical scores do not consider etiologic microbial agents. We aimed to assess whether PADIT and UPCM scores could be implemented when bacteria or fungi are known to be causative of infection, and how these agents affected the outcome. Methods and results A retrospective analysis of patients undergone cardiac implantable electronic device (CIED) pocket revision, and/or TLE between 2016 and 2021 was performed. For each procedure, microbiological samples of both generator pocket tissue and intracardiac portions of the leads were analysed. In addition, blood cultures were performed in three sets. Transesophageal echocardiography was performed in all cases for ruling out suspected endocarditis. Spearman ad Pearson coefficients were tested for correlation among microorganism, prior infection and/or procedure, PADIT and UPCM scores; a P-value less than 0.05 was considered significant. We analysed 14 patients (10 males, 4 females, mean age ± SD: 72 ± 13): one case (4%) affected by pocket erosion, seven cases (50%) affected by both pocket site and lead infection (with associated bacteraemia in one subject), and one case (4%) due to lead-related infective endocarditis. Of these, five (36%) underwent device replacement, while nine (64%) to extraction or pocket/lead revision. Nine (64%) patients had positive culture examinations (Figure 1). The correlation method gave a statistically significant association between Gram- infection and prior sepsis (r 0.63; P-value 0.02). We considered the number of procedures on the same pocket and/or CIED previous infections as markers of frailty and increased infectious risk. As expected, the PADIT score, but not UPCM, significantly correlated with the number of previous procedures (r 0.70; P-value 0.006). Indeed, both scores had a similar infectious risk prediction. Conclusions In our analysis, predictive PADIT score of infectious risk performed better than UPCM, while both proved their reliability in identifying high-risk patients. The absence of correlation between UPCM score and infective agents is not conclusive, but probably due to the small sample size. Interestingly, growing rate of device reinfection correlates with the risk of Gram- bacterial infection. Thus, the integration of the microbiological data in the current prediction models could significantly increase their performance.

Long-term implications of pacemaker insertion in younger adults: a single centre experience

Abstract Background The long-term implications of pacemaker insertion in younger adults are poorly described in the literature. Methods We performed a retrospective analysis of consecutive younger adult patients (18–50 years) undergoing pacemaker implantation at a quaternary hospital between 1986–2020. Defibrillators and cardiac resynchronisation therapy devices were excluded. All clinical records, pacemaker checks and echocardiograms were reviewed. Results 81 patients (39.5±9.6 years, 53% male) underwent pacemaker implantation. Indications were complete heart block (41%), sinus node dysfunction (33%), high grade AV block (11%) and tachycardia-bradycardia syndrome (7%). During a median 7.6 (IQR=0.6–14.8) years follow-up, 9 patients (11%) developed 13 late device-related complications (generator or lead malfunction requiring reoperation (n=11), device infection (n=1) and pocket revision (n=1)). Five of these patients were &amp;lt;40 years old at time of pacemaker insertion. At long-term follow-up, a further 9 patients (11%) experienced significant symptoms from inadequate lead performance managed with device reprogramming. Sustained ventricular tachycardia was detected in 2 patients (2%). Deterioration in ventricular function (LVEF decline &amp;gt;10%) was observed in 14 patients (17%) and 7 of these patients required subsequent biventricular upgrade. Furthermore, 4 patients (5%) developed new tricuspid regurgitation (≥ moderate-severe). Of 69 patients with available long-term pacing data, minimal pacemaker utilisation (pacing &amp;lt;5% at all checks) was observed in 13 (19%) patients. Conclusions Pacemaker insertion in younger adults has significant long-term implications. Clinicians should carefully consider pacemaker insertion in this cohort given risk of device-related complications, potential for device under-utilisation and issues related to lead longevity. In addition, patients require close follow-up for development of structural abnormalities and arrhythmias. Funding Acknowledgement Type of funding sources: None.

Antibiotic selection and risk profiles in patients receiving antibacterial cardiovascular implantable electronic device envelopes – a real world sample and analysis

Abstract Background The use of a cardiovascular implantable electronic device (CIED) envelope impregnated with antibiotics provides short-term local antibiotic delivery in the implant pocket and may lower infection risk. Biologic antibacterial (BIO) envelopes, such as the porcine extracellular matrix (ECM) device hydrated with antibiotics, facilitate active remodeling of the pocket into vital, vascularized tissue and provide short-term local antibiotic delivery. Limited clinical data is available on real-world clinician patient selection criteria, antibiotic choices, or clinical outcomes. Purpose To explore antibiotic hydration solution physician choices with respect to patient profiles, and to determine post-implant infection outcomes in patients receiving a CIED BIO envelope. Methods A post-hoc sub-analysis of a multicenter, non-randomized study of 1017 patients receiving a biologic envelope (hydrated with or without antibiotics) during CIED procedures (SECURE Study) assessed antibiotic hydration choices, patient risk profiles, and the type and timing of infection for days 0–90 post procedure. Patient selection and antibiotic hydration choice were at the discretion of the treating physician. Results 850 patients received BIO envelopes, with a mean age of 71.9 years, and 60.5% having ≥2 standard infection risk factors. High power devices accounted for 47.6% and reoperations for 44.0% of the procedures. Antibiotic choice for envelope hydration prior to implantation is described in Table 1 below. Also, antibiotic combinations with gentamicin were used in 18.1% and other antibiotic combinations in 9.2% of patients. Patients receiving gentamicin hydrated BIO envelopes (BIO+G) trended toward fewer pocket infections vs. those without gentamicin (BIO-G) (0.0% vs. 1.6%, p=0.070) but the overall pocket infection rate of 1.2% was not significantly different based upon antibiotic choice. In a multivariate logistic regression model designed to predict the total infection rate, the use of gentamicin was associated with a 3-fold reduction in likelihood of infection, OR 3.0 (1.0–10.0); AUC=0.70. No differences in overall infection rates among patients undergoing lead or pocket revision only procedures (0.0% vs. 0.0%) or other major adverse events were observed based upon antibiotic usage. Conclusions Real world clinical decision-making regarding antibiotic choice for biologic antibacterial envelopes varies among implanting clinicians and influences observed outcomes. The use of biologic antibacterial envelopes hydrated with gentamicin was associated with a lower likelihood of infection within 90 days when compared to biologic envelopes hydrated without gentamicin. Clinical trials to optimize patient selection processes and determine the best antibiotic choice when employing a CIED envelope merit further investigation. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): The work was supported by Aziyo Biologics, Inc. Table 1. BIO Envelope Hydration