[Prevention, diagnosis and treatment of cardiac implantable electronic device infections. Position paper of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC)]. / Prevenzione, diagnosi e trattamento delle infezioni dei dispositivi cardiaci elettronici impiantabili. Position paper dell'Associazione Italiana di Aritmologia e Cardiostimolazione (AIAC).

The number of cardiac implantable electronic device (CIED) implantations has increased over recent years as a result of population growth, increasing life expectancy, adoption of guidelines, and better access to healthcare. Device-related infection is, however, one of the most serious complications of CIED therapy associated with significant morbidity, mortality, and financial healthcare burden. Although many preventive strategies such as administration of intravenous antibiotic therapy before implantation are well recognized, uncertainties still exist about other regimens. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, anti-bacterial envelopes, prolonged antibiotics post-implantation, and others. The key aspect to successful treatment of definite CIED infections is complete removal of all parts of the system and transvenous hardware, including the device and all leads. Thus, transvenous lead extraction has been increasing. Expert consensus statements on how to prevent, diagnose, and treat CIED infections and on lead extraction have been published by the European Heart Rhythm Association in 2020 and 2018, respectively. The aim of this AIAC position paper is to describe the current knowledge on the risks for device-related infections and to assist healthcare professionals in their clinical decision making regarding its prevention, diagnosis, and management by providing the latest update of the most effective strategies.

Procedure, management, and outcome of subcutaneous implantable cardioverter-defibrillator extraction in clinical practice.

AIMS: Subcutaneous implantable cardioverter-defibrillator (S-ICD) therapy is expanding rapidly. However, there are few data on the S-ICD extraction procedure and subsequent patient management. The aim of this analysis was to describe the procedure, management, and outcome of S-ICD extractions in clinical practice. METHODS AND RESULTS: We enrolled consecutive patients who required complete S-ICD extraction at 66 Italian centres. From 2013 to 2022, 2718 patients undergoing de novo implantation of an S-ICD were enrolled. Of these, 71 required complete S-ICD system extraction (17 owing to infection). The S-ICD system was successfully extracted in all patients, and no complications were reported; the median procedure duration was 40 (25th-75th percentile: 20-55) min. Simple manual traction was sufficient to remove the lead in 59 (84%) patients, in whom lead-dwelling time was shorter [20 (9-32) months vs. 30 (22-41) months; P = 0.032]. Hospitalization time was short in the case of both non-infectious [2 (1-2) days] and infectious indications [3 (1-6) days]. In the case of infection, no patients required post-extraction intravenous antibiotics, the median duration of any antibiotic therapy was 10 (10-14) days, and the re-implantation was performed during the same procedure in 29% of cases. No complications arose over a median of 21 months. CONCLUSION: The S-ICD extraction was safe and easy to perform, with no complications. Simple traction of the lead was successful in most patients, but specific tools could be needed for systems implanted for a longer time. The peri- and post-procedural management of S-ICD extraction was free from complications and not burdensome for patients and healthcare system. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov/Identifier: NCT02275637.

Pacemaker dependency after transcatheter aortic valve implantation: incidence, predictors and long-term outcomes.

AIMS: The aims of this study were to determine the appropriateness of permanent pacemaker implantation (PPI) after TAVI through an analysis of PM dependency at follow-up, and to assess long-term outcomes of patients undergoing PPI after TAVI. METHODS AND RESULTS: From June 2007 to February 2018, 1,116 consecutive patients without prior PM underwent TAVI in our institution. We assessed the incidence and predictors of PM dependency of patients who underwent PPI within 30 days, and also the six-year outcomes among patients who did not undergo PPI at 30 days. At 30 days, PPI was reported in 145 patients (13.0%). Rates of PM dependency were 35.7%, 35.8% and 33.3% at 1, 6 and 12 months, respectively. Analysing PPI timing, implantation on day 1 was found to be a predictor of PM dependency at six months (OR 20.7 [95% CI: 3.4-126.7]; p=0.001) and 12 months (OR 7.5 [95% CI: 1.4-40.2]; p=0.019). An interaction between PM dependency and the presence of baseline right bundle branch block (RBBB) at six months (pinteraction=0.024) and 12 months (pinteraction=0.028) was reported when PPI was performed on the same day as TAVI. At six years, patients who received a PM at 30 days showed a higher all-cause death rate (KM estimate 41.7% vs 57%; plog-rank=0.034). CONCLUSIONS: Among patients receiving PPI after TAVI, PM dependency rates were about 33-36% at one year. Patients with a baseline RBBB undergoing PPI at day 0 or at day 1 when severe CDs persisted for 24 hours after TAVI, irrespective of baseline CDs, had a higher chance of being PM-dependent at follow-ups. Finally, PPI after TAVI was associated with increased six-year mortality.

Ventricular arrhythmias in aortic valve stenosis before and after transcatheter aortic valve implantation.

AIMS: Transcatheter aortic valve implantation (TAVI) is a therapeutic treatment for patients with severe aortic stenosis (AS) at high surgical risk. Although the procedure is associated with a reduction in total mortality, there are no data regarding changing in the incidence of premature ventricular contractions (PVCs) and ventricular arrhythmias (VAs) after TAVI. The aim of this study was to assess the incidence of VAs before and after TAVI. METHODS AND RESULTS: We enrolled 237 patients who underwent TAVI at our centre. Ninety-one patients were excluded for the following reasons: presence of prior permanent pacemaker (PPM) (n = 20), new PPM implant after TAVI (n = 48), death during the follow-up period (n = 16), and lost at follow-up (n = 7). Finally, 146 patients were included in our analysis. The presence of VAs was evaluated in all patients recording a 24 h Holter monitoring before the procedure and after 1 and 12 months. Ventricular arrhythmias were classified according to a modified Lown grading system. Before the procedure, isolates PVCs (grade 1-2 of Lown grading system) were present in 34.9% of patients (n = 51). Complex PVCs (grade 3-4a-4b of Lown grading system) were present in 48.6% of the population (multifocal PVCs in 32 patients, 21.9%; pairs in 25 patients, 17.1%; ventricular tachycardia in 14 patients, 9.6%). One month after the procedure, we observed statistically significant incidence decrease of arrhythmias of grade 3 (from 21.9 to 17.1%) and grade 4 (pairs from 17.1 to 12.3%; ventricular tachycardia from 9.6 to 4.8%). After 12 months, there was a further significant reduction in the frequency and severity of PVCs. In particular, 45.8% of patients had isolates PVCs (<30 in all given hours of monitoring in 45 patients, 30.8%; higher than 30 in any hour of monitoring in 22 patients, 15%) while the frequency of complex arrhythmias was reduced to 16.4% (multifocal PVCs in 13 patients, 9%; couplets 8 patients, 5.5% and ventricular tachycardia in 3 patients, 2.0%). The difference was statistically significant (P < 0.01). CONCLUSION: This study indicates that VAs are common in patients with AS. We observed a significant decrease in the incidence and severity of PVCs since the first month after TAVI. Furthermore, after 1 year follow-up there was a further and significant reduction in the frequency of complex PVCs. This may be related to the benefits determined by valve replacement on left ventricular function.

Selection of patient for cardiac resynchronization therapy: role of QT corrected dispersion.

AIMS: About 30 to 50% of patients undergoing cardiac resynchronization therapy (CRT) may not show clinical or echocardiographic improvement, despite fulfilling guidelines recommendations for CRT. For this reason, we need a more accurate method to assess CRT eligibility. The aims of this study were to verify, on a 12-month follow-up, the usefulness of QT corrected dispersion (QTcD) in a patient's selection for CRT. METHODS: We stratified 53 patients who underwent CRT, into two groups based on the estimation of QTcD, that is, QTcD > 60 ms and QTcD ≤ 60 ms. In all patients were performed New York Heart Association (NYHA) class determination, six-minute walking test, QtcD, and QRS measurements, and complete echocardiographic assessment at 1, 3, 6, and 12 months after implantation. RESULTS: At baseline, there were no significant differences in clinical, echocardiographic, and electrocardiographic parameters duration between two groups. At 12-month follow-up between the two groups, there were significant differences in NYHA (1.2 ± 0.4 vs 2 ± 0.6; P < 0.01), six-minute walking distance (422 ± 68 vs 364 ± 68; P < 0.01), left ventricular (LV) ejection fraction (34 ± 7% vs 28 ± 6%; P < 0.01), LV end-diastolic diameter (57 ± 7 vs 63 ± 8; P < 0.01), and LV intraventricular dyssynchrony (24 ± 14 vs 39 ± 23; P < 0.01). CONCLUSION: This study suggests that QTc dispersion in addition to QRS duration could improve the sensitivity of electrocardiogram in a patient's selection for CRT.

Incidence rate and predictors of permanent pacemaker implantation after transcatheter aortic valve implantation with self-expanding CoreValve prosthesis.

BACKGROUND: Conduction disorders and permanent pacemaker (PPM) implantation are common complications in patients undergoing transcatheter aortic valve implantation (TAVI). Previous studies, evaluating small populations, have identified several different predictors of PPM implantation after TAVI. The aim of this study was to assess the incidence rate of conduction disorders and the predictors of postoperative PPM requirement in a large series of patients undergoing TAVI. METHODS: Data were analyzed from 181 consecutive patients at high-risk surgery who underwent TAVI at our institute between July 2007 and April 2011. All patients underwent implantation of the third-generation percutaneous self-expanding CoreValve® prosthesis (CoreValve, Inc., Irvine, CA, USA). In all patients, a 12-lead electrocardiogram and a 24-h holter monitoring was recorded before and after the procedure in order to assess the presence of conduction disorders. Clinical data, preoperative conduction disorders, echocardiographic patterns, and procedural data were tested as predictors of PPM implantation after TAVI. RESULTS: Left bundle branch block (LBBB) was the most common conduction disorder, with an incidence of 50.3% at discharge. Fifty-two (32.1%) patients developed a persistent complete AVB requiring PPM implantation. PPM implantation was strongly correlated with the presence of preoperative right bundle branch block (RBBB) which was found to be the only independent predictor of PPM implantation (HR 16.5, CI 3.3-82.3, p < 0.001). CONCLUSIONS: LBBB and PPM implantation requirement after TAVI are common occurrences using the self-expanding CoreValve prosthesis. In this large series of consecutive patients, only RBBB was found to be a strong predictor of PPM requirement.

Functional and clinical implications of cardiac resynchronization therapy on outcomes of diabetic patients with heart failure.

AIMS: To compare functional and structural changes of the left ventricle and long-term clinical outcomes in diabetic and nondiabetic patients with heart failure undergoing cardiac resynchronization therapy (CRT). METHODS: Sixty-eight patients with heart failure undergoing CRT were included: 18 were diabetic patients and 50 nondiabetic patients. The CRT eligibility was established by echocardiographic assessments. RESULTS: CRT improved ventricular geometry and dyssynchrony in both diabetic and nondiabetic patients, with no significant difference in the magnitude of the effects on the left ventricular function. Over a median follow-up of 30.6 ± 6.2 months, there were no significant differences in the rates of any cause death (16.7 vs. 14.0%, P = 0.72), cardiac death (11.1 vs. 8.0%, P = 0.65) and heart rehospitalization (5.6 vs. 6.0%, P = 1.0), between diabetic and nondiabetic patients, respectively. Diabetes was not found to be an independent factor associated with worse clinical outcome. CONCLUSION: Resynchronization therapy provided significant functional and hemodynamic improvements in both diabetic and nondiabetic patients. Long-term prognosis in heart failure patients with diabetes was comparable with that in those without diabetes.

Intraoperative defibrillation threshold testing during implantable cardioverter-defibrillator insertion: do we really need it?

BACKGROUND: The assessment of defibrillation efficacy using a safety margin of 10 J has long been the standard of care for insertion of implantable cardioverter-defibrillator (ICD), but physicians are concerned about complications related to induction test. Therefore, the need for testing has been recently questioned. The aim of our study was to assess the impact of defibrillation threshold (DFT) testing of ICD on the efficacy of ICD therapy. METHODS: We analyzed data obtained from follow-up visits of 122 consecutive patients who underwent ICD implantation at our institute from April 1996 to June 2008, with (n = 42) or without (n = 80) DFT testing. Patients in the DFT group were less likely to be men (83.3% vs 96.3%, P < .031) than those in the non-DFT group. Conversely, the 2 groups were similar in age, left ventricular ejection fraction at baseline, functional class, and underlying cardiovascular disease. Results during a 12-month follow-up, 13 (31.0%) and 30 (37.5%) ventricular tachyarrhythmic episodes were recorded in the DFT and non-DFT groups, respectively (P = .472). Antitachycardia pacing (ATP) terminated most of episodes, reducing the need of defibrillation at 7.7% in the DFT group and 3.3% in the non-DFT group (P = .533). Similar percentages of inappropriate ATP interventions (7.1% vs 3.8%, P = .413) and shock deliveries (2.4% vs 5.0%, P = .659) were recorded between DFT and non-DFT groups. CONCLUSIONS: At 1-year follow-up, the performance of DFT testing does not seem to add any significant efficacy advantage in patients undergoing ICD implantation. Prospective randomized trials and long-term follow-up are warranted to clarify whether routine DFT testing may be safely abandoned leading to a revision of current guidelines.

Early conduction disorders following percutaneous aortic valve replacement.

BACKGROUND: Percutaneous aortic valve replacement (PAVR) may be an alternative therapy for patients with severe aortic stenosis who are denied valve surgery because of age and comorbidity. Data are few regarding the incidence of early conduction disorders (CD) after PAVR. We examined the incidence and characteristics of CD in the immediate postoperative period after PAVR, and the need for permanent pacemaker (PPM) implantation. METHODS AND RESULTS: Between June 2007 and June 2008 30 patients (mean age = 82.1 +/- 8.5 years) underwent PAVR in our institution. The incidence of new, postoperative CD, diagnosed by 12-lead or 24-hour Holter electrocardiogram, was 68.0%. Left bundle branch block was the most common conduction abnormality, with an incidence of 45.8%. The incidence of complete atrioventricular block requiring PPM implantation was 20%. CONCLUSIONS: We observed a higher incidence of early conduction disorders and need for PPM implantation after PAVR than generally reported after surgery. Whether this observation is clinically important requires larger prospective studies and follow up.