Low Occurrence of Infections and Death in a Real-World Cohort of Patients with Cardiac Implantable Electronic Devices.

BACKGROUND: The incidence of infections and death in patients implanted with cardiac implantable electronic devices (CIEDs) is not fully known yet. AIM: To describe the incidence of CIED-related infection and death, and their potential predictors in a contemporary cohort of CIED patients. METHODS: All consecutive patients implanted with a CIED at our institution were prospectively enrolled. Follow-up visits were performed 2 weeks after CIED implantation for all patients, and then every 6 months for implantable cardioverter defibrillator (ICD)/cardiac resynchronization therapy (CRT) patients and every 12 months for pacemaker (PM) patients. The adjudication of CIED-related infections was performed by two independent investigators and potential disagreement was resolved by a senior investigator. RESULTS: Between September 2016 and August 2020, a total of 838 patients were enrolled (34.6% female; median age 77 (69.6-83.6); median PADIT score 2 (2-4)). PMs were implanted in 569 (68%) patients and ICD/CRT in 269 (32%) patients. All patients had pre-implant antibiotic prophylaxis and 5.5% had an antibiotic-eluting envelope. Follow-up data were available for 832 (99.2%) patients. After a median follow-up of 42.3 (30.2-56.4) months, five (0.6%) patients had a CIED-related infection and 212 (25.5%) patients died. Using multivariate Cox regression analysis, end-stage chronic kidney disease (CKD) requiring dialysis and therapy with corticosteroids was independently associated with a higher risk of infection (hazard ratio (HR): 14.20; 95% confidence interval (CI) 1.48-136.62 and HR: 14.71; 95% CI 1.53-141.53, respectively). Age (HR: 1.07; 95% CI 1.05-1.09), end-stage CKD requiring dialysis (HR: 6.13; 95% CI 3.38-11.13) and history of atrial fibrillation (HR: 1.47; 95% CI 1.12-1.94) were independently associated with all-cause death. CONCLUSIONS: In a contemporary cohort of CIED patients, mortality was substantially high and associated with clinical factors depicting a population at risk. On the other hand, the incidence of CIED-related infections was low.

Implantation of cardiac electronic devices in active COVID-19 patients: Results from an international survey.

BACKGROUND: Cardiac implantable electronic device (CIED) implantation rates as well as the clinical and procedural characteristics and outcomes in patients with known active coronavirus disease 2019 (COVID-19) are unknown. OBJECTIVE: The purpose of this study was to gather information regarding CIED procedures during active COVID-19, performed with personal protective equipment, based on an international survey. METHODS: Fifty-three centers from 13 countries across 4 continents provided information on 166 patients with known active COVID-19 who underwent a CIED procedure. RESULTS: The CIED procedure rate in 133,655 hospitalized COVID-19 patients ranged from 0 to 16.2 per 1000 patients (P <.001). Most devices were implanted due to high-degree/complete atrioventricular block (112 [67.5%]) or sick sinus syndrome (31 [18.7%]). Of the 166 patients in the study survey, the 30-day complication rate was 13.9% and the 180-day mortality rate was 9.6%. One patient had a fatal outcome as a direct result of the procedure. Differences in patient and procedural characteristics and outcomes were found between Europe and North America. An older population (76.6 vs 66 years; P <.001) with a nonsignificant higher complication rate (16.5% vs 7.7%; P = .2) was observed in Europe vs North America, whereas higher rates of critically ill patients (33.3% vs 3.3%; P <.001) and mortality (26.9% vs 5%; P = .002) were observed in North America vs Europe. CONCLUSION: CIED procedure rates during known active COVID-19 disease varied greatly, from 0 to 16.2 per 1000 hospitalized COVID-19 patients worldwide. Patients with active COVID-19 infection who underwent CIED implantation had high complication and mortality rates. Operators should take these risks into consideration before proceeding with CIED implantation in active COVID-19 patients.

Radiotherapy-induced malfunctions of cardiac implantable electronic devices in cancer patients.

The number of patients with cardiac implantable electronic devices (CIEDs) requiring radiation therapy (RT) for cancer treatment is increasing. The purpose of this study is to estimate the prevalence, possible predictors, and clinical impact of RT-related CIEDs malfunctions. We retrospectively reviewed the medical records of all pacemaker (PM)/implantable cardioverter-defibrillator (ICD) patients who underwent RT in the last 14 years. One hundred and twenty-seven patients who underwent 150 separate RT courses were analysed (99 with a PM and 27 with an ICD). Of note, 21/127 (16.6%) patients were PM-dependent. Neutron-producing RT was used in 37/139 (26.6%) courses, whereas non-neutron-producing RT was used in 102/139 (73.4%) courses. The cumulative dose (Dmax) delivered to the CIED exceeded 5 Gy only in 2/132 (1.5%) cases. Device malfunctions were observed in 3/150 (2%) RT courses, but none was life-threatening or led to a major clinical event and all were resolved by CIED reprogramming. In all cases, the Dmax delivered to the CIED was < 2 Gy. Two malfunctions occurred in the 37 patients treated with neutron-producing RT (5.4%), and 1 malfunction occurred in the 102 patients treated with non-neutron-producing RT (1%) (p = 0.17). Device relocation from the RT field was performed in 2/127 (1.6%) patients. RT in patients with CIED is substantially safe if performed in an appropriately organized environment, with uncommon CIEDs malfunctions and no major clinical events. Neutron-producing energies, rather than Dmax, seem to increase the risk of malfunctions. Device interrogation on a regular basis is advised to promptly manage CIED malfunctions.

Cardiac device therapy in patients with left ventricular dysfunction and heart failure: 'real-world' data on long-term outcomes (mortality, hospitalizations, days alive and out of hospital).

BACKGROUND: The impact on long-term outcomes of implantable cardioverter defibrillators (ICDs) and biventricular defibrillators for cardiac resynchronization (CRT-D) devices in 'real world' patients with heart failure (HF) needs to be assessed in terms of clinical effectiveness. METHODS AND RESULTS: A registry including consecutive HF patients who underwent a first implant of an ICD (891 patients) or a CRT-D device (709 patients) in 2006-2010 was followed (median 1487 days and 1516 days, respectively), collecting administrative data on survival, all-cause hospitalizations, cardiovascular or HF hospitalizations, and days alive and out of hospital (DAOH). Survival free from death/cardiac transplant was 61.9% and 63.8% at 5 years for ICD and CRT-D patients, respectively. Associated comorbidities (Charlson Comorbidity Index) had a significant impact on death/cardiac transplant, as well as on hospitalizations. The median values of DAOH% were 97.4% for ICD and 97.7% for CRT-D patients, but data were highly skewed, with the lower quartile of DAOH% values including values ranging between 0% and 52.8% for ICD and between 0% and 56.1% for CRT-D patients. Charlson Comorbidity Index was a very strong predictor of DAOH%. CONCLUSIONS: Patients who were implanted in 'real world' clinical practice with an ICD or a CRT-D device have, on average, a relatively favourable outcome, with a survival of around 62-64% at 5 years, but with an important burden of hospitalizations. Comorbidities, as evaluated by means of the Charlson Comorbidity Index, have a significant impact on outcomes in terms of mortality/heart transplant, hospitalizations and days spent alive and out of hospital.

Cardiac resynchronization therapy: implant rates, temporal trends and relationships with heart failure epidemiology.

BACKGROUND: Consensus guidelines define indications for cardiac resynchronization therapy (CRT), but the variability in implant rates in 'real world' clinical practice, as well as the relationship with the epidemiology of heart failure are not defined. METHODS AND RESULTS: In Emilia-Romagna, an Italian region with around 4.4 million inhabitants, a registry was instituted to collect data on implanted devices for CRT, with (CRT-D) or without defibrillation (CRT-P) capabilities. Data from all consecutive patients resident in this region who underwent a first implant of a CRT device in years 2006-2010 were collected and standardized (considering each of the nine provinces of the region). The number of CRT implants increased progressively, with a 71% increase in 2010 compared to 2006. Between 84 and 90% of implants were with CRT-D devices. The variability in standardized implant rates among the provinces was substantial and the ratio between the provinces with the highest and the lowest implant rates was always greater than 2. Considering prevalent cases of heart failure in the period 2006-2010, the proportion of patients implanted with CRT per year ranged between 0.23 and 0.30%. CONCLUSIONS: The application in 'real world' clinical practice of CRT in heart failure is quite heterogeneous, with substantial variability even among areas belonging to the same region, with the need to make the access to this treatment more equitable. Despite the increased use of CRT, its overall rate of adoption is low, if a population of prevalent heart failure patients is selected on the basis of administrative data on hospitalizations.

Indexed maximal left atrial volume predicts response to cardiac resynchronization therapy.

AIMS: Cardiac resynchronization therapy (CRT) has shown morbidity and mortality benefits in patients with advanced congestive heart failure (HF). Since about one-third of the patients did not appear to respond to CRT, it would seem reasonable to try to identify patients more accurately before implantation. Left atrial (LA) dimension has been proposed as a powerful outcome predictor in patients with heart disease. Accordingly, the aim of this study is to prospectively assess the predictive value of LA for selecting CRT responders. METHODS: Fifty two consecutive patients with refractory HF, sinus rhythm and left bundle branch block were enrolled in the study and planned for CRT implantation. Clinical and echocardiographic evaluations were performed before CRT implantation and after 6 months. Three LA volumes indexed to body surface area (iLAV) were computed to evaluate the LA complexity: maximal LAV (iLAVmax), LAV just before atrial systole (iLAVpre), and minimal LAV (iLAVpost). CRT responders were defined as those who presented a reduction of >10% in LVESVi at 6-month follow-up. RESULTS: Responders (63%) and nonresponders (37%) had similar baseline clinical characteristics and pre-implantation LV volumes. However, baseline LA volumes were significantly associated with the extent of LV reverse remodeling: in particular, baseline iLAVmax was remarkably lower in responders than in nonresponders (50.2±14.1 ml/m(2) vs 65.8±15.7 ml/m(2), p=0.001) resulting predictive for CRT response. CONCLUSION: Patients with small iLAV result as better responders to CRT than larger one. iLAVmax is an independent predictor of LV reverse remodeling and allows to indentify the best candidates for CRT.

Cardiac resynchronization therapy-defibrillator improves long-term survival compared with cardiac resynchronization therapy-pacemaker in patients with a class IA indication for cardiac resynchronization therapy: data from the Contak Italian Registry.

AIMS: In candidates for cardiac resynchronization therapy (CRT), the choice between pacemaker (CRT-P) and defibrillator (CRT-D) implantation is still debated. We compared the long-term prognosis of patients who received CRT-D or CRT-P according to class IA recommendations of the European Society of Cardiology (ESC) and who were enrolled in a multicentre prospective registry. METHODS AND RESULTS: A total of 620 heart failure patients underwent successful implantation of a CRT device and were enrolled in the Contak Italian Registry. This analysis included 266 patients who received a CRT-D and 108 who received a CRT-P according to class IA ESC indications. Their survival status was verified after a median follow-up of 55 months. During follow-up, 73 CRT-D and 44 CRT-P patients died (rate 6.6 vs. 10.4%/year; log-rank test, P = 0.020). Patients receiving CRT-P were predominantly older, female, had no history of life-threatening ventricular arrhythmias, and more frequently presented non-ischaemic aetiology of heart failure, longer QRS durations, and worse renal function. However, the only independent predictor of death from any cause was the use of CRT-P (hazard ratio, 1.97; 95% confidence interval, 1.21-3.16; P = 0.007). CONCLUSION: The implantation of CRT-D, rather than CRT-P, may be preferable in patients presenting with current class IA ESC indications for CRT. Indeed, CRT-D resulted in greater long-term survival and was independently associated with a better prognosis.

Effect of cardiac resynchronization therapy on left atrial reverse remodeling: role of echocardiographic AV delay optimization.

BACKGROUND/OBJECTIVES: Cardiac resynchronization therapy (CRT) improves left ventricular (LV) function in patients with advanced heart failure (HF) and there are some evidences about beneficial effects also on left atrial (LA) dimension and function. The contribution of atrioventricular delay (AVD) optimization on LA changes has not been evaluated. The purpose of the present study was to further investigate the effect of CRT on LA reverse remodelling and to evaluate the contribution of AVD optimization. METHODS AND RESULTS: From the Cardiology Department of Piacenza Hospital and Modena University Hospital fifty one patients with refractory systolic HF and left bundle branch block were prospectively enrolled before CRT implantation. Patients were 1:1 randomized to either an optimized AVD (AV Opt group) determined by continuous wave Doppler aortic velocity-time integral (VTI) or an empiric AVD of 110 ms (AV Fixed group). Optimal AVD was defined as the AVD that yielded the largest aortic VTI at one of eight tested AV intervals (between 60 and 200 ms). LA volumes and emptying fractions were assessed by two-dimensional echocardiography at baseline and 6 months after CRT. At 6-month follow-up, CRT induced LA reverse remodeling in the whole population (maximal LA volume: 55.8 ± 16.4 ml/m² vs 50.3 ± 18.9 ml/m², p=0.006; pre-systolic LA volume: 47.0 ± 15.2 ml/m² vs 41.4 ± 17.4 ml/m², p=0.003; post-systolic LA volume: 36.4 ± 15.0 ml/m² vs 30.3 ± 18.0 ml/m(2), p=0.001); nevertheless, no substantial difference was observed about LA structural and functional remodeling between both AV Opt group and AV Fixed group. CONCLUSION: CRT induces LA reverse remodeling that appears independent from AVD optimization.

Indexed left atrial volume predicts the recurrence of non-valvular atrial fibrillation after successful cardioversion.

AIMS: Atrial fibrillation (AFib) induces remodelling of the left atrium (LA). Indexed LA volume (iLAV) as more accurate measure of LA size has not been evaluated as predictor of recurrence of AFib after cardioversion. METHODS AND RESULTS: We identified 411 adults (mean age 64.1 ± 11.4 years, 34.5% women) who underwent successful cardioversion and with no history of other atrial arrhythmia, stroke, congenital heart disease, valvular dysfunction, surgery, thyroid dysfunction, acute or chronic inflammatory disease, and pacemaker. All echocardiographic data were retrieved from the laboratory database. iLAV was measured off-line using Simpson's method. Clinical characteristics and recurrence of clinical AFib were determined by review of medical records. Patients with scheduled follow-up of at least 6 months were included. About 250 patients (60.8%) developed AFib recurrence after a median (25th-75th percentile) follow-up of 345.0 (210.0-540.0) days. Patients with AFib recurrence had significantly greater iLAV than patients without AFib recurrence (39.7 ± 8.4 vs. 31.4 ± 4.6, P < 0.001). Each mL/m(2) increase in iLAV was associated with a 30% increased risk of AFib recurrence [odds ratio (OR) 1.30, confidence interval (CI) 1.23-1.38, P < 0.001]. In a multivariable model, each mL/m(2) increase in iLAV was independently associated with a 21% increase in the risk of AFib recurrence (OR 1.21, CI 1.11-1.30, P < 0.001). The areas under receiver operating characteristic curves, generated to compare LA diameter and iLAV as predictors of AFib recurrence, were 0.59 ± 0.3 and 0.85 ± 0.2, respectively (P < 0.001). CONCLUSION: The present study is the first to show that larger iLAV before cardioversion, as a more accurate measure of LA remodelling than LA diameter, is strongly and independently associated with higher risks of AFib recurrence.

Radiofrequency catheter ablation of common atrial flutter in a patient with anomalous inferior vena cava and azygos continuation.

We describe a case of isthmus-dependant atrial flutter ablation with a superior approach due to an anomalous inferior vena cava (IVC), azygos, and emiazygos continuation. A 56-year-old man was referred to our institution for the treatment of a common atrial flutter. Two years prior, the patient had an attempted electrophysiological study not performed due to the inability to advance the guidewire through IVC. A computed tomography of the abdominal venous system revealed the absence of the subrenal IVC, azygos, and emiazygos continuation. Following double puncture of the left subclavian vein, two catheters were inserted into the coronary sinus and into the right atrium. Programmed atrial stimulation was performed and a sustained isthmus-dependant right atrial tachycardia was obtained. After 11 applications of radiofrequency energy with an inversion technique, sinus rhythm was restored and a repeat atrial programmed stimulation failed to induce any arrhythmia.

Evidence of reverse remodeling after long-term biventricular stimulation for resynchronization in patients with wide QRS selected on the basis of echocardiographic electromechanical delays.

BACKGROUND: There is increasing evidence that cardiac resynchronization therapy (CRT) may trigger an inverse remodeling process leading to decreased left ventricular (LV) volumes in patients with heart failure and wide QRS. However, it is still important to simplify patient selection and achieve a widely applicable parameter to better stratify patients who are candidates for CRT. METHODS: Eighteen patients (13 males, 5 females, mean age 67.5 +/- 7.2 years) with advanced heart failure due to ischemic (n = 12) or idiopathic dilated cardiomyopathy (n = 6) and complete left bundle branch block received biventricular pacing. The patients were considered eligible in the presence of echocardiographic evidence of intra- and interventricular asynchrony, defined on the basis of LV electromechanical delay. Investigations were performed before pacemaker implantation (at baseline), the day after, and 3 and 6 months later. RESULTS: Two patients died before the first outpatient examination. There were 15 (83%) responders to reverse remodeling among the remainder. In the overall population, there was a significant and progressive improvement in LV sphericity indexes, ejection fraction, mitral regurgitation area and LV volumes (p < 0.001). The improvement in the interventricular mechanical delay after CRT was significantly correlated with the decrease in LV end-systolic volume (r2 = 0.2558, p = 0.04). CONCLUSIONS: CRT reduces LV volumes in patients with advanced heart failure, complete left bundle branch block and detailed documentation of ventricular asynchrony prior to therapeutic pacing. Broadly applicable Doppler echocardiographic measures may increase the specificity of the long-term response to CRT in terms of LV performance.