Incidence and Predictors of Infections and All-Cause Death in Patients with Cardiac Implantable Electronic Devices: The Italian Nationwide RI-AIAC Registry.

BACKGROUND: The incidence of infections associated with cardiac implantable electronic devices (CIEDs) and patient outcomes are not fully known. AIM: To provide a contemporary assessment of the risk of CIEDs infection and associated clinical outcomes. METHODS: In Italy, 18 centres enrolled all consecutive patients undergoing a CIED procedure and entered a 12-months follow-up. CIED infections, as well as a composite clinical event of infection or all-cause death were recorded. RESULTS: A total of 2675 patients (64.3% male, age 78 (70-84)) were enrolled. During follow up 28 (1.1%) CIED infections and 132 (5%) deaths, with 152 (5.7%) composite clinical events were observed. At a multivariate analysis, the type of procedure (revision/upgrading/reimplantation) (OR: 4.08, 95% CI: 1.38-12.08) and diabetes (OR: 2.22, 95% CI: 1.02-4.84) were found as main clinical factors associated to CIED infection. Both the PADIT score and the RI-AIAC Infection score were significantly associated with CIED infections, with the RI-AIAC infection score showing the strongest association (OR: 2.38, 95% CI: 1.60-3.55 for each point), with a c-index = 0.64 (0.52-0.75), p = 0.015. Regarding the occurrence of composite clinical events, the Kolek score, the Shariff score and the RI-AIAC Event score all predicted the outcome, with an AUC for the RI-AIAC Event score equal to 0.67 (0.63-0.71) p < 0.001. CONCLUSIONS: In this Italian nationwide cohort of patients, while the incidence of CIED infections was substantially low, the rate of the composite clinical outcome of infection or all-cause death was quite high and associated with several clinical factors depicting a more impaired clinical status.

Concomitant screening of coronary artery disease and lung cancer with a new ultrafast-low-dose Computed Tomography protocol: A pilot randomised trial.

We performed a pilot randomised study to assess the feasibility and radiation exposure of a new computed tomography (CT) protocol that allows screening of both coronary artery disease (CAD) and lung cancer. Current or former heavy smokers at high lung cancer risk with indication to cardiac CT for suspected or known CAD were randomised to undergo concomitant CT evaluation of either cardiac or thoracic area or cardiac CT only. Out of 129 subjects deemed eligible for the study, 110 agreed to participate and were randomised to simultaneous cardiac and lung CT (Gr.A; n = 55) or cardiac CT only (Gr.B; n = 55). The feasibility (i.e. adequate visualization of coronary artery segments) was noninferior with simultaneous cardiac and lung CT compared with the standard cardiac CT (870 of 889 segments [97%] in Gr.A vs 878/890 segments [99%] in Gr.B; mean difference 2.0% [90% confidence interval: -0.3% to 4.1%]). The safety (i.e. effective radiation dose) of the concomitant cardiac and lung CT protocol was noninferior to the standard cardiac CT (1.5 [95% confidence intervals: 1.2-1.7] vs. 1.4 [95% confidence intervals: 1.1-1.6] mSv; mean difference 0.1 mSv [90% confidence interval: -0.2 to 0.3 mSv]). In the two groups, a total of 25 significant (>70%) coronary stenoses were found at cardiac CT (9/55 cases of Gr.A vs 11/55 cases of Gr.B). Pulmonary nodules >2 mm were detected in 7 of the 55 Gr.A subjects. This pilot randomised study shows that concomitant CAD and lung cancer screening by means of a new CT protocol is both feasible and safe, thus allowing a comprehensive evaluation of both cardiac and thoracic regions during one CT scanning only. (ClinicalTrials.gov Identifier: NCT03727958).

Detection of Biofilm-associated Implant Pathogens in Cardiac Device Infections: High Sensitivity of Sonication Fluid Culture Even in the Presence of Antimicrobials.

INTRODUCTION: Sonication showed more sensitivity than traditional culture in the diagnosis of device infections. Aims of the study were to assess the role of sonication in the microbiological diagnosis and management of cardiac device infections (CDIs), to evaluate the sensitivity of sonication in patients on antimicrobial therapy at the time of device removal, and to analyze biofilm formation of the isolated strains. MATERIALS AND METHODS: A total of 90 devices (31 generators and 59 electrodes) collected from 31 patients with infection underwent sonication before culture. Devices were sonicated for 5 min and centrifuged at 3200 rpm for 15 min. Intraoperative traditional cultures were performed in 26 patients. Microorganisms were identified using conventional methods. Staphylococcal strains were tested for slime production. RESULTS: Microbiological diagnosis was achieved in 28 patients (90%). Sonicate fluid was positive in 68/90 (76%) of devices (27/31 [87%] generators and 41/59 [69%] electrodes), whereas intraoperative pocket swabs grew bacteria in 10/26 patients (38%, P = 0.0007). Among leads, 37/59 (62.7%) yielded bacteria even in the absence of vegetation. Coagulase-negative Staphylococci accounted for 83.8% (57/68) of the total; Staphylococcus aureus and Gram-negative bacilli were found in 4.4% (3/68) and 5.8% (4/68), respectively. Biofilm production was present in 15/22 (69%) staphylococcal strains. Overall, patients on therapy (n = 23) had a microbiological diagnosis in 20/23 (86.9%) and 7/22 (30.4%) through sonication and intraoperative cultures, respectively (P = 0.0002). DISCUSSION: Our data showed the high sensitivity of sonication in the diagnosis of CDIs, even in patients under antimicrobial therapy. CONCLUSION: Sonication represents an essential tool for both diagnosis and management of CDIs.

Comparison of partners-heart failure algorithm vs care alert in remote heart failure management.

AIM: To compare the utility of the partners-heart failure (HF) algorithm with the care alert strategy for remote monitoring, in guiding clinical actions oriented to treat impending HF. METHODS: Consecutive cardiac resynchronization-defibrillator recipients were followed with biweekly automatic transmissions. After every transmission, patients received a phone contact in order to check their health status, eventually followed by clinical actions, classified as "no-action", "non-active" and "active". Active clinical actions were oriented to treat impending HF. The sensitivity, specificity, positive and negative predictive values and diagnostic accuracy of the partners-HF algorithm vs care alert in determining active clinical actions oriented to treat pre-HF status and to prevent an acute decompensation, were also calculated. RESULTS: The study population included 70 patients with moderate to advanced systolic HF and QRS duration longer than 120 ms. During a mean follow-up of 8 ± 2 mo, 665 transmissions were collected. No deaths or HF hospitalizations occurred. The sensitivity and specificity of the partners-HF algorithm for active clinical actions oriented to treat impending HF were 96.9% (95%CI: 0.96-0.98) and 92.5% (95%CI: 0.90-0.94) respectively. The positive and negative predictive values were 84.6% (95%CI: 0.82-0.87) and 98.6% (95%CI: 0.98-0.99) respectively. The partners-HF algorithm had an accuracy of 93.8% (95%CI: 0.92-0.96) in determining active clinical actions. With regard to active clinical actions, care alert had a sensitivity and specificity of 11.05% (95%CI: 0.09-0.13) and 93.6% respectively (95%CI: 0.92-0.95). The positive predictive value was 42.3% (95%CI: 0.38-0.46); the negative predictive value was 71.1% (95%CI: 0.68-0.74). Care alert had an accuracy of 68.9% (95%CI: 0.65-0.72) in determining active clinical actions. CONCLUSION: The partners-HF algorithm proved higher accuracy and sensitivity than care alert in determining active clinical actions oriented to treat impending HF. Future studies in larger populations should evaluate partners-HF ability to improve HF-related clinical outcomes.

Bidirectional tachycardia after an acute intravenous administration of digitalis for a suicidal gesture.

Acute digoxin intoxication is a life-threating condition associated with severe cardiotoxicity. Female gender, age, low lean body mass, hypertension, and renal insufficiency may worsen the prognosis. Arrhythmias caused by digitalis glycosides are characterized by an increased automaticity coupled with concomitant conduction delay. Bidirectional tachycardia is pathognomonic of digoxin intoxication, but it is rarely observed. An 83-year-old woman was admitted to the Emergency Department after self-administration of 5 mg of digoxin i.v. for suicidal purpose. Her digoxin serum concentration was 17.4 ng/mL. The patient developed a bidirectional tachycardia and the Poison Control Center of the hospital provided digoxin immune fab. Bidirectional tachycardia quickly reversed and the patient remained stable throughout the hospital stay. This case shows that a multiple disciplinary approach, involving cardiologists and toxicologists, is essential for the management of digoxin intoxication. The optimal treatment of this rare event depends on the clinical conditions and on the serum drug concentration of the patient. Digoxin immune fab represents a safe, effective, and specific method for rapidly reversing digitalis cardiotoxicity and should be started as soon as the diagnosis is defined.

Sonication of explanted cardiac implants improves microbial detection in cardiac device infections.

The sonication technique has been shown to be a promising tool for microbiological diagnosis of device-related infections. We evaluated the usefulness of the sonication method for pathogen detection in 80 explanted cardiac components collected from 40 patients, and the results were compared with those of conventional cultures. Forty subjects undergoing cardiac device removal were studied: 20 had cardiac device infection, and 20 subjects underwent elective generator replacement or revision in the absence of infection. Sonication of explanted devices was more sensitive than traditional culture for microbial detection (67% and 50%, respectively; P = 0.0005). The bacterial count detected in sonication fluid culture was significantly higher than that detected in traditional culture in both infected (P = 0.019) and uninfected (P = 0.029) devices. In the infected patients, sonication fluid culture yielded a significantly higher rate of pathogen detection in explanted electrodes than traditional culture (65% versus 45%; P = 0.02), while no differences were found in the generators. Ten strains were detected only through sonication fluid culture: 6 Staphylococcus epidermidis strains, 1 Staphylococcus hominis strain, 2 Corynebacterium striatum strains, and 1 Brevundimonas sp. Neither the type nor the duration of antimicrobial therapy before device removal had an effect on the diagnostic performance of sonication fluid culture (P = 0.75 and P = 0.56, respectively). In the patients without infection, sonication fluid culture was positive in 8 cases (40%), whereas conventional culture was positive in only 4 (20%). In summary, the sonication technique improves the microbiological diagnosis of explanted cardiac devices.

Retrospective case-control analysis of patients with staphylococcal infections receiving daptomycin or glycopeptide therapy.

Glycopeptides have been considered the antimicrobials of choice for serious meticillin-resistant Staphylococcus aureus (MRSA) and meticillin-resistant coagulase-negative staphylococci (MR-CoNS) infections for several years. Daptomycin is a new option for the treatment of these infections, including those exhibiting reduced susceptibility to glycopeptides. The aim of this study was to compare glycopeptides and daptomycin for the treatment of infections caused by MRSA or MR-CoNS. Data for 106 patients with bloodstream infections (bacteraemia or infective endocarditis) or skin and soft-tissue infections (SSTIs) were retrospectively reviewed, of which 43 were treated with daptomycin (DAP group) and 63 were treated with vancomycin or teicoplanin (GLYCO group). Patients included in the two comparison groups were homogeneous in terms of age, risk factors and clinical severity. Aetiology was mainly represented by MRSA in both groups, followed by various species of MR-CoNS. Daptomycin was used more frequently in patients with central venous catheter-associated bacteraemia or pacemaker-associated infection. Patients with SSTIs included in the GLYCO group had a longer mean duration of antibiotic therapy (18.2 days vs. 14.6 days; P=0.009) and a longer mean length of hospital stay (28.2 days vs. 19.6 days; P=0.01) compared with those included in the DAP group. A longer mean duration of antibiotic therapy was also observed in patients with bloodstream infections receiving glycopeptide therapy (25.6 days vs. 18 days; P=0.004). In conclusion, the good clinical efficacy of daptomycin is associated with a more rapid resolution of the clinical syndrome and a reduced length of hospitalisation. This latter aspect may have important pharmacoeconomic implications, promoting the use of daptomycin in the clinical setting.

Additive value of right ventricular dyssynchrony indexes in predicting the success of cardiac resynchronization therapy: a speckle-tracking imaging study.

BACKGROUND: The purpose of our study was to analyze the evolution of left and right ventricular (LV, RV) parameters before and after cardiac resynchronization therapy (CRT) using speckle-tracking imaging (STI). METHODS AND RESULTS: Eighty-one patients with dilated cardiomyopathy (New York Heart Association functional class III or IV), left bundle branch block (QRS ≥120 ms), and LV ejection fraction ≤35% were studied with STI echocardiography before and after CRT. LV longitudinal (LV-SD12-l), radial (LV-SD6-r), and circumferential (LV-SD6-c) intraventricular dyssynchrony and LV twist (LV-t) were determined. RV dyssynchrony (RV-SD6) was defined as the standard deviation of the 6 time to peak systolic strain values. At 6 months' follow-up after CRT, the degree of dyssynchrony correlated significantly with LV ejection fraction improvement and end-systolic volume reduction. In receiver operating characteristic curve analysis, the following variables predictive of successful CRT were obtained: LV-SD12-l (area under the curve [AUC] 0.69), LV-SD6-c (AUC 0.66), LV-SD6-r (AUC 0.79), LV-t (AUC 0.81), and RV-SD6+LV-SD6-r (AUC 0.83). By combining LV and RV intraventricular dyssynchrony (LV-SD12-l + LV-SD6-r + RV-SD6), the AUC was significantly improved to 0.89 (P < .005 compared with RV-SD6+LV-SD6-r; P < .001 compared with LV-t). CONCLUSIONS: Our data show that assessment of RV dyssynchrony parameters has an incremental value in the evaluation of candidates for CRT and may supplement LV dyssynchrony information.

Upstream effect for atrial fibrillation: still a dilemma?

Atrial fibrillation is the most common arrhythmia in clinical practice. Ion channel blocking agents are often characterized by limited long-term efficacy and several side effects. In addition, ablative invasive procedures are neither easily accessible nor always efficacious. The "upstream therapy," which includes angiotensin-converting enzyme inhibitors, aldosterone receptor antagonists, statins, glucocorticoids, and ω-3 poly-unsaturated fatty acids, targets arrhythmia substrate, influencing atrial structural and electrical remodeling that play an essential role in atrial fibrillation induction and maintenance. The mechanisms involved and the most important clinical evidence regarding the upstream therapy influence on atrial fibrillation are presented in this review. Some open questions are also proposed.

Efficacy of ivabradine administration in patients affected by inappropriate sinus tachycardia.

BACKGROUND: Inappropriate sinus tachycardia (IST) is characterized by an elevated heart rate (HR) at rest and an exaggerated HR response to physical activity or emotional stress. Beta-blockers and calcium channel blockers are the first-line therapy but sometimes are poorly tolerated due to side effects. OBJECTIVE: The purpose of this study was to evaluate the efficacy and safety of ivabradine, a selective inhibitor of the I(f) current of the sinoatrial node, in patients affected by IST. METHODS: Eighteen consecutive symptomatic patients (2 men and 16 women; mean age 45 +/- 15 years) affected by IST were enrolled in the study. Every patient underwent resting ECG, 24-hour Holter ECG, and exercise ECG at baseline and at 3-month and 6-month follow-up. RESULTS: Sixteen patients (14 women; mean age 41 +/- 14 years) completed the study. Holter ECG assessment showed a significant reduction of medium HR (P <.001) and maximal HR (P <.001, basal vs 3-6 months; P = .02, 3 vs 6 months). Minimal HR slightly decreased at 3 months and then stabilized (P = .49, 3 vs 6 months) despite an increased drug dose. Stress test showed a significant decrease at rest (P <.001) and maximal HR (P <.05), suggesting an increased tolerance to physical stress, which was confirmed by a progressive increase of maximal load reached (>100 W) during stress test at 3 months (75%) and 6 months (85%). One patient was excluded because of phosphenes despite dose lowering, and another patient did not complete the protocol. CONCLUSION: Ivabradine could represent an effective and safe alternative to calcium channel blockers and beta-blockers for treatment of IST.