Tighter is better: Can a simple and cost-free parameter predict response to cardiac synchronization therapy?

BACKGROUND: Several studies have evaluated the role of QRS duration (QRSd) or QRS narrowing as a predictor of response to cardiac resynchronization therapy (CRT) to reduce nonresponders. AIM: Our study aimed to determine the correlation between the relative change in QRS index (QI) compared to clinical outcome and prognosis in patients who underwent CRT implantation. METHODS: A three-centers study involving 398 patients with a CRT device was conducted. Clinical, echocardiographic and pharmacological variables, QRSd before and after CRT implantation and QI were measured. RESULTS: In a 6-month follow-up, a significant improvement in left ventricular ejection fraction (LVEF), left ventricular end-diastolic and systolic volumes (LVEDV and LVESV) were observed. QI was related to reverse remodeling (multiple r-squared: 0.48, adjusted r-squared: 0.43, p = .001), and the cut-off value that best predicted LV reverse remodeling after 6 months of CRT was 12.25% (AUC 0.7, p = .001). At 24 months, a statistically significant difference was found between patients with a QI ≤ 12.25% and those with a QI > 12.25% regarding NYHA class worsening (p = .04). The mean of the QI of patients who died from cardiovascular causes was lower than patients who died of other causes (p = .0179). A correlation between pre-CRT QRSd/LVEDV and QI was observed (r = + 0.20; p = .0003). A higher QRSd/LVEDV ratio was associated with an improved LVEF, LVEDV, and LVESV (p < .0001) at follow-up. CONCLUSIONS: QI narrowing after CRT was related to greater echocardiographic reverse remodeling and a lower rate of adverse events (death or cardiovascular hospitalizations). The QI can improve the prediction of adverse events in a population with CRT regardless of comorbidities according to the Charlson Comorbidity Index. QI could be used to predict CRT response.

Leadless pacemakers as a new alternative for pacemaker lead-related superior vena cava syndrome: A case report.

Superior vena cava (SVC) syndrome is a rare disease induced by thrombosis and consequent occlusion of SVC, negatively affecting morbidity and mortality. The incidence of SVC syndrome from central venous catheters and pacemaker or defibrillator leads is increasing. Optimal treatment of pacemaker or defibrillator-related SVC syndrome is not well defined. Lead extraction causes mechanical trauma to the vessel wall. In addition, subsequent device implantation on the contralateral side can be an added factor for venous occlusion. The use of leadless pacemakers could be an interesting option to reduce the risk of SVC restenosis after lead extraction. We report a clinical case of PM leads-related SVC syndrome referred to our centers and treated with transvenous lead extraction, leadless pacemaker implantation and subsequent percutaneous angioplasty and stenting of the SVC and left innominate vein.

Impact of COVID-19 lockdown in patients with implantable cardioverter and cardiac resynchronization therapy defibrillators: insights from daily remote monitoring transmissions.

In Italy, a strict lockdown was imposed from 8 March 2020 to stop the spread of the coronavirus disease 2019 (COVID-19). We explored the effect of this lockdown on data transmitted by remote monitoring (RM) of implantable cardioverter and cardiac resynchronization therapy defibrillators (ICDs/CRT-Ds). RM daily transmissions from ICDs and CRT-Ds were analyzed and compared in two consecutive 1 month frames pre and post-lockdown: period I (7 February-7 March 2020) and period II (8 March-7 April 2020). The study cohort included 180 patients (81.1% male, 63.3% ICDs and 36.7% CRT-Ds) with a median age of 70 (interquartile range 62-78) years. The median value of physical activity provided by accelerometric sensors showed a significant reduction between period I and II [13.1% (8.2-18.1%) versus 9.4% (6.3-13.8%), p < 0.001]. Eighty nine % of patients decreased their activity, for 43.3% the relative reduction was ≥ 25%. The mean heart rate decreased significantly [69.2 (63.8-75.6) bpm vs 67.9 (62.7-75.3) bpm, p < 0.001], but with greater reduction (≈3 beats/minute) in patients aged < 70 years. Resting heart rate and thoracic impedance showed minor variations. No differences were observed in device pacing % and arrhythmias. In cardiac patients, the lockdown imposed to contain COVID-19 outbreak significantly reduced the amount of physical activity and the mean heart rate. These side effects of in-home confinement quarantine should be taken in consideration for frail patients.

The influence of age on the psychological profile of patients with cardiac implantable electronic devices: results from the Italian population in a multicenter study conducted by the European Heart Rhythm Association.

BACKGROUND: Cardiac implantable electronic devices (CIEDs) are widely used to treat bradyarrhythmias or improve the prognosis of patients with heart failure (HF). AIMS: To evaluate age-related (≤ 75 vs. > 75 years) attitudes, worries, psychological effects and needs in an Italian CIEDs population. METHODS: Patients attending their periodical ambulatory evaluation received a questionnaire conceived by the European Heart Rhythm Association Scientific Initiatives Committee as part of a multicenter, multinational snapshot survey. Seven countries participated in the study, and 1646 replies were collected. Of these, 437 (27%) were from Italy. Present results refer to the Italian population only. CIEDs were stratified into devices to treat bradycardia or HF. RESULTS: The use of CIEDs was more common in advanced age. Older patients needed less information about CIEDs than younger ones (p = 0.044), who would prefer to be better informed about CIEDs-related consequences on psychologic profile (p = 0.045), physical (p < 0.001) and sexual (p < 0.001) activities, and driving limitations (p = 0.003). When compared to older subjects, younger individuals experienced more difficulties (p = 0.035), especially in their professional (p < 0.001) and private life (p = 0.033), feeling their existence was limited by the device (p < 0.001). Conversely, quality of life (HRQL) more often improved in the elderly (p = 0.001). Information about what to do with CIEDs at the end of life is scant independently of age. CONCLUSIONS: HRQL after CIEDs implantation improves more frequently in older patients, while the psychological burden of CIEDs is usually higher in younger patients. End of life issues are seldom discussed.

Severe Spontaneous Echo Contrast/Auricolar Thrombosis in "Nonvalvular" AF: Value of Thromboembolic Risk Scores.

BACKGROUND: Patients with atrial fibrillation (AF) have an increased thromboembolic risk that can be estimated with risk scores and sometimes require oral anticoagulation therapy (OAT). Despite correct anticoagulation, some patients still develop left atrial spontaneous echo contrast (SEC) or thrombosis. The value of traditional risk scores (R2 CHADS2 , CHADS2 , and CHA2 DS2 -VASc) in predicting such events remains controversial. METHODS AND RESULTS: The aim of our study was to explore variables linked to severe SEC or atrial thrombosis and evaluate the performance of traditional risk scores in identifying these patients. In order to do this, we retrospectively analyzed 568 patients with nonvalvular nonparoxysmal AF who underwent electrical cardioversion from January 2011 to December 2016 after OAT for a minimum of 4 weeks. A transesophageal echocardiogram was performed in 265 patients for various indications, and 24 exhibited left atrial SEC or thrombosis. Female gender, history of heart failure or left ventricular ejection fraction <40%, and high levels (>1 mg/dL) of C-reactive protein (CRP) were independently associated with left atrial SEC/thrombosis. A score composed by these factors (denominated HIS [Heart Failure, Inflammation, and female Sex]) showed a sensitivity of 79% and a specificity of 60% (area under receiver operating characteristic curve 0.695, P = 0.002) in identifying patients with a positive transesophageal echo; traditional risk scores did not perform as well. CONCLUSIONS: In patients with persistent AF and suboptimal anticoagulation, a risk score composed by history of heart failure, high CRP, and female gender identifies patients at high risk of left atrial SEC/thrombosis when its value is >1.

Prognostic Impact of QRS Axis Deviation in Patients Treated With Cardiac Resynchronization Therapy.

INTRODUCTION: QRS duration and morphology are currently recognized as recommended criteria for the selection of CRT candidates. It has recently been shown that patients with left bundle branch block (LBBB) derive substantial clinical benefit from CRT. The aim of this study is to investigate the prognostic impact of QRS axis deviation (AD) in HF patients with LBBB undergoing CRT. METHODS AND RESULTS: We retrospectively evaluated 707 HF patients with LBBB who underwent CRT at five centers. Baseline QRS axis was defined as normal (NA: -30° to 90°), right axis deviation (RAD: 90° to 180°) and left axis deviation (LAD: <-30°). The primary endpoint was a composite of all cause death/HF hospitalization. The risk of endpoint by AD was evaluated with both Kaplan-Meier and Cox proportional hazard analysis. Among 707 patients (73% M, median age: 71 [62,77] years), 323 (46%) had NA, 359 (51%) LAD, and 25 (3.5%) RAD. Baseline clinical characteristics were similar between the three groups. Over a mean follow-up of 32 ± 25 months, 141 deaths occurred (21%) and 36% (n = 255) met with the composite endpoint. A significantly higher proportion of RAD patients (52%) reached the endpoint (LAD 40%, NA 30%). KM analysis showed that RAD and LAD patients had worse event free survival and in multivariate analysis both LAD (HR: 1.40; 95% CI: 1.05-1.86; P = 0.021) and RAD (HR: 2.49; 95% CI: 1.31-4.74; P = 0.005) were independently associated with worse clinical outcome. CONCLUSIONS: Right or left axis deviation in the presence of LBBB in HF patients undergoing CRT are independent predictors of poor prognosis.

Simplified Selvester Score: a practical electrocardiographic instrument to predict response to CRT.

AIMS: To investigate the LBBB Selvester Scoring System (LBBB-SSc) and the Simplified-SSc prognostic impact in predicting response to CRT, all cause and cardiac mortality, heart failure (HF) hospitalizations and onset of arrhythmias in HF patients undergoing CRT. METHODS: We retrospectively evaluated LBBB-SSc and Simplified-SSc of 172 consecutive HF patients with true-LBBB who underwent CRT. Response to CRT was defined as the improvement of LVEF of at least 10% or as the reduction of LVESV of at least 15% at 6-month follow-up. Logistic regression analysis and Cox proportional hazard analysis were performed to evaluate each endpoint related risk according to LBBB-SSc and Simplified-SSc. RESULTS: The LBBB-SSc and the Simplified-SSc were inversely correlated with response to CRT. Myocardial scar at both scores was independently associated to non-response to CRT. No correlation was observed between LBBB-SSc or Simplified-SSc and other endpoints. CONCLUSIONS: In HF patients with true-LBBB, Simplified-SSc is able to predict response to CRT.

CHADS2 and CHA2DS2-VASc scores to predict morbidity and mortality in heart failure patients candidates to cardiac resynchronization therapy.

AIMS: CHADS2 and CHA2DS2-VASc scores are pivotal in assessing the risk of stroke in atrial fibrillation patients, and were recently proved to predict hospitalizations and mortality in specific clinical settings. Aim of this study was to evaluate whether these scores could predict clinical outcomes [first hospitalization for heart failure (HF) and a combined event of HF hospitalization and death for any cause] in patients candidates to cardiac resynchronization therapy and implantable defibrillator (CRT-D). METHODS AND RESULTS: In a retrospective multicentre Italian study, we enrolled 559 consecutive HF patients candidates to CRT-D, and we grouped them in three pre-specified risk classes: low (CHADS2/CHA2DS2-VASc 1-2), moderate (CHADS2/CHA2DS2-VASc 3-4), and high (CHADS2 5-6/CHA2DS2-VASc 5-8). All patients underwent regular follow-up at implanting centres every 6 months; data collection was extended till the 72th month of follow-up. At a median FU of 30 months, 143 patients (25.4%) were hospitalized for HF and 110 (19.5%) died. Event-free survival analysis showed a significant difference according to baseline CHADS2 and CHA2DS2-VASc scores (Log-Rank for HF P < 0.001 for CHADS2 and CHA2DS2-VASc; Log-Rank for combined end-point P = 0.001 for CHADS2, P < 0.001 for CHA2DS2-VASc). At multivariate analysis, independent predictors of endpoints were: previous atrial fibrillation (AF) or AF at implant, NYHA class, QRS duration and the CHA2DS2-VASc score (for HF hospitalization P = 0.013; for the combined event, P = 0.007), while the CHADS2 score was not independently associated with either the end-points. CONCLUSION: In CRT-D patients, pre-implant CHA2DS2-VASc score is an independent predictor of major clinical events at 30-month follow-up.

[New frontiers in pacing: from myocardial pacing to conduction system pacing]. / Nuove frontiere dell'elettrostimolazione: dal pacing del miocardio comune al pacing del sistema di conduzione.

For many years, cardiac pacing has been based on the stimulation of right ventricular common myocardium to correct diseases of the conduction system. The birth and the development of cardiac resynchronization have led to growing interest in the correction and prevention of pacing-induced dyssynchrony. Many observational studies and some randomized clinical trials have shown that conduction system pacing (CSP) can not only prevent pacing-induced dyssynchrony but can also correct proximal conduction system blocks, with reduction of QRS duration and with equal or greater effectiveness than biventricular pacing. Based on these results, many Italian electrophysiologists have changed the stimulation target from the right ventricular common myocardium to CSP. The two techniques with greater clinical impact are the His bundle stimulation and the left bundle branch pacing. The latter, in particular, because of its easier implantation technique and better electric parameters, is spreading like wildfire and is representing a real revolution in the cardiac pacing field. However, despite the growing amount of data, until now, the European Society of Cardiology guidelines give a very limited role to CSP.

Application of the Seattle Heart Failure Model in patients on cardiac resynchronization therapy.

BACKGROUND: The Seattle Heart Failure Model (SHFM) is a multimarker risk assessment tool able to predict outcome in heart failure (HF) patients. AIM: To assess whether the SHFM can be used to risk-stratify HF patients who underwent cardiac resynchronization therapy with (CRT-D) or without (CRT) an implantable defibrillator. METHODS AND RESULTS: The SHFM was applied to 342 New York Heart Association class III-IV patients who received a CRT (23%) or CRT-D (77%) device. Discrimination and calibration of SHFM were evaluated through c-statistics and Hosmer-Lemeshow (H-L) goodness-of-fit test. Primary endpoint was a composite of death from any cause/cardiac transplantation. During a median follow-up of 24 months (25th-75th percentile [pct]: 12-37 months), 78 of 342 (22.8%) patients died; seven patients underwent urgent transplantation. Median SHFM score for patients with endpoint was 5.8 years (25th-75th pct: 4.25-8.7 years) versus 8.9 years (25th-75th pct: 6.6-11.8 years) for those without (P < 0.001). Discrimination of SHFM was adequate for the endpoint (c-statistic always ranged around 0.7). The SHFM was a good fit of death from any cause/cardiac transplantation, without significant differences between observed and SHFM-predicted survival. CONCLUSION: The SHFM successfully stratifies HF patients on CRT/CRT-D and can be reliably applied to help clinicians in predicting survival in this clinical setting.

Electrocardiographic criteria of true left bundle branch block: a simple sign to predict a better clinical and instrumental response to CRT.

BACKGROUND: Cardiac resynchronization therapy (CRT) has proved to be very effective in improving morbidity and mortality in patients affected with severe congestive heart failure. Its efficacy has been shown to be greater in patients with left bundle branch block (LBBB). The aim of our study was to verify if newly proposed criteria for true LBBB identify patients with a better clinical and instrumental response to CRT. METHODS: Between May 2007 and April 2011, 111 patients with left ventricular ejection fraction (LVEF) ≤ 35% and LBBB morphology received a CRT device and were divided into two groups according to QRS morphology. Group 1 (61 patients) consisted of patients with "true" LBBB morphology; group 2 (50 patients) consisted of patients with "false" LBBB. The primary endpoint was the utility of criteria for true LBBB to predict a composite endpoint of all-cause mortality and hospital admission with heart failure. The secondary endpoint was the utility of the same criteria to predict an absolute increase in LVEF ≥ 10%. RESULTS: "False" LBBB morphology and a dose of bisoprolol <5 mg at last follow-up were the only parameters related to clinical outcome in multivariate analysis (respectively: hazard ratio [HR] 3.98, confidence interval [CI] 95% 1.51-10.48; HR 0.15, CI 95% 0.05-0.43). "True" LBBB morphology was the only variable significantly related to a greater increase in LVEF (HR 4.57, CI 95% 1.36-8.28). CONCLUSION: True LBBB morphology is related to a higher event-free survival rate in CRT patients and better echocardiographic response.

[Management of infections in patients with cardiac implantable electronic devices]. / La gestione delle infezioni nei pazienti portatori di dispositivi impiantabili.

Implantation of pacemakers and cardiac defibrillators is a life-saving treatment but can put our patients at risk of infections, increasing morbidity and mortality and prolonging hospitalization with a significant financial healthcare burden. A preventive strategy is crucial but, while several strategies such as administration of intravenous antibiotic therapy before implantation are well recognized, other uncertainties remain. The main gaps regard the use of periprocedural measures, including antibacterial envelope to prevent device infection, the appropriate management of antithrombotic therapy before and after device implantation and timing of device reimplantation. To address these issues, some important randomized clinical trials and a European Heart Rhythm Association consensus document have recently been published. The aim of this article is to review current knowledge on the management of infections in patients with cardiac implantable electronic devices to help not only electrophysiologists, but also physicians in their daily practice.

Reduction of admissions for urgent and elective pacemaker implant during the COVID-19 outbreak in Northern Italy.

AIMS: The coronavirus disease-19 (COVID-19) outbreak has been recently associated with lower hospitalization rates for acute coronary syndromes. Aim of the study was to investigate whether a similar behaviour is observed in admissions for urgent pacemaker implant. METHODS: This retrospective study included 1315 patients from 18 hospitals in Northern Italy with a high number of COVID-19 cases. Hospitalization rates for urgent pacemaker implant were compared between the following periods: 20 February to 20 April 2020 (case period); from 1 January to 19 February 2020 (intra-year control period); from 20 February to 20 April 2019 (inter-year control period). RESULTS: The incidence rate of urgent implants was 5.0/day in the case period, 6.0/day in the intra-year control period and 5.8/day in the inter-year control period. Incidence rate in the case period was significantly lower than both the intra-year [incidence rate ratio (IRR): 0.81, 95% CI 0.67-0.99, P = 0.040] and inter-year control periods (IRR: 0.79, 95% CI 0.66-0.95, P = 0.012); this reduction was highest after the national lockdown (IRR 0.68, 95% CI 0.52-0.91, P = 0.009). The prevalence of residents in rural areas undergoing urgent pacemaker implant was lower in the case period (36%) than in both the intra-year (47%, P = 0.03) and inter-year control periods (51%, P = 0.002). Elective pacemaker implants also decreased in the case period, with the incidence rate here being 3.5/day vs. 6.4/day in the intra-year (-45%) and 6.9/day in the inter-year period (-49%). CONCLUSION: Despite severe clinical patterns, the COVID-19 outbreak has negatively affected the population presentation to Emergency Departments for bradyarrhythmias requiring urgent pacemaker implant in Northern Italy. This mainly occurred after the national lockdown and concerned patients living in rural areas.

Actions elicited during scheduled and unscheduled in-hospital follow-up of cardiac devices: results of the ATHENS multicentre registry.

AIM: The number of cardiac implantable electronic devices (CIEDs) is continuously growing and this translates into a high number of in-hospital follow-ups. This workload justifies the increasing popularity of remote monitoring systems for the follow-up of CIEDs. The ATHENS registry was designed to find out what actions are taken during in-hospital follow-up of CIEDs at 10 different centres in Northern Italy. METHODS AND RESULTS: Between 1 March 2010 and 30 June 2010, all patients who came to our centres for a follow-up of their CIEDs were enrolled in the registry. We defined as visit with an action (VWA) a follow-up that elicited an action in that patient. The primary endpoint was the prevalence of VWA on the whole population. The secondary endpoints were: prevalence of VWA on the pacemaker (PM) population; prevalence of VWA on the implantable cardioverter defibrillator (ICD) population; prevalence of VWA on the cardiac resynchronization therapy (CRT) population; predictors of VWA in univariate and multivariate analyses. A total of 3362 patients were recruited. The primary endpoint was reached in 762 patients, 22.8% of patients (95% CI 21.4-24.3). The prevalence of action was highest for CRT (29.8%), followed by PM (22.8%) and ICD (18.6%). In a multivariate model, the prevalence of action was higher for CRT, than for PM and was lowest for ICD and it was higher for unscheduled visits and first visits than for scheduled visits. CONCLUSIONS: Our registry demonstrates that 'some actions' are taken during about 20% of scheduled in-hospital follow-up of CIEDs. These data should encourage the use of remote follow-up systems.

A case of inefficient defibrillation during thoracotomy.

We describe the case of an accidental intraoperative ventricular fibrillation that could not be interrupted by a 35-J shock fired by an implantable cardioverter defibrillator (ICD). We believe that the iatrogenic pneumothorax induced by thoracotomy during the epicardial lead implant temporarily changed the intrathoracic impedance, causing an increase in defibrillation threshold. This possible change in impedance with resulting ineffective interruption of arrhythmia should be taken in consideration when a thoracotomy is planned in a patient bearing an ICD.

Remote monitoring temporal trends during COVID-19 pneumonia in patients with implanted defibrillators.

It is unknown whether some of the clinical parameters transmitted by remote monitoring (RM) of cardiac implanted devices could show recurrent patterns caused by COVID-19 infection. Our aim was to describe RM daily temporal trends for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) recipients during COVID-19 infection. A 65-year-old woman with a CRT-D had a sudden increase of approximately 15 bpm and 10 bpm in nocturnal and mean heart rate, respectively, 11 days before hospitalization for COVID-19 pneumonia. At the same time physical activity decreased progressively and continuously. A 78-year-old woman with an ICD showed significant changes in RM trends starting from the COVID-19-related symptoms: strong decrease in physical activity, progressive increase in mean and nocturnal heart rate, irregular trend of heart rate variability, and rapid drop in thoracic impedance. Two months later, on hospitalization, computed tomography showed a "crazy-paving" pattern of the lungs, which is a clinical picture of COVID-19 pneumonia with concomitant pleural effusion. .

[Arrhythmias and sudden death in neuromuscular disorders]. / Aritmie e morte improvvisa nelle malattie neuromuscolari.

Neuromuscular diseases (NMD) are a broadly defined group of disorders that all involve injury or dysfunction of peripheral nerves, neuromuscular junction or muscle, often with dominant or recessive pattern of inheritance. Cardiac involvement is uncommon, in particular with cardiomyopathies and brady/tachyarrhythmias. The causes of cardiac involvement are unclear: replacement fibrosis, alteration of membrane permeability, sympathetic hyperactivity, or accumulation of toxic metabolites can play a role in the pathogenesis of cardiac disorders. The early diagnosis is of pivotal importance to prevent evolution of the disease: electrocardiographic alterations and arrhythmias, particularly if associated with family history for cardiomyopathy or sudden death, can be an early signal of cardiomyopathy associated with NMD. Genetic analysis can improve prognostic stratification, particularly related to arrhythmic risk, and guide to a tailored therapy.

Oral anticoagulation and clinical outcomes in COVID-19: An Italian multicenter experience.

BACKGROUND: Since the body of evidence addressing the coagulation derangements caused by Coronavirus disease (COVID-19) has been constantly growing, we investigated whether pre-hospitalization oral anticoagulation (OAC) or in-hospital heparin treatment could have a protective role among COVID-19 patients. METHOD: In this cohort study, consecutive COVID-19 patients admitted to four different Italian Institutions were enrolled. Baseline demographic, clinical, laboratory, and radiological characteristics, as well as in-hospital treatment and outcomes were evaluated. The primary outcome was mortality. RESULTS: A total of 844 COVID-19 patients were enrolled as study cohort, n = 65 (7.7%) taking OACs prior to hospitalization. Regarding clinical outcomes, OAC patients developed acute hypoxemic respiratory failure (AHRF) more frequently than non-OAC patients as well as presenting a higher mortality rate (44.6% vs 19.8%, p < 0.001). At overall multivariate logistical regression, use of heparin (n = 394, 46.6%) was associated with a better chance of survival to hospital discharge (OR 0.60 [0.38-0.94], p < 0.001), in particular in patients with AHRF, with no association found with the use of OACs. In a sub-analysis, the highest mortality rate was found for AHRF patients when heparin was not administered. CONCLUSION: In our cohort, OACs appeared to be ineffective in reducing mortality rate, while heparin resulted to be a useful treatment when lung disease was sufficiently severe, potentially suggesting a crucial role of microthrombosis in severe COVID-19. Due to the relatively small number of COVID-19 patients treated with OACs included in our analysis and their higher number of comorbidities, larger studies are needed in order to confirm our findings.

Impact of prior statin use on clinical outcomes in COVID-19 patients: data from tertiary referral hospitals during COVID-19 pandemic in Italy.

BACKGROUND: Epidemiological evidence suggests that anti-inflammatory and immunomodulatory properties of statins may reduce the risk of infections and infection-related complications. OBJECTIVE: We aimed to assess the impact of prior statin use on coronavirus disease (COVID-19) severity and mortality. METHODS: In this observational multicenter study, consecutive patients hospitalized for COVID-19 were enrolled. In-hospital mortality and severity of COVID-19 assessed with National Early Warning Score (NEWS) were deemed primary and secondary outcomes, respectively. Propensity score (PS) matching was used to obtain balanced cohorts. RESULTS: Among 842 patients enrolled, 179 (21%) were treated with statins before admission. Statin patients showed more comorbidities and more severe COVID-19 (NEWS 4 [IQR 2-6] vs 3 [IQR 2-5], p < 0.001). Despite having similar rates of intensive care unit admission, noninvasive ventilation, and mechanical ventilation, statin users appeared to show higher mortality rates. After balancing pre-existing relevant clinical conditions that could affect COVID-19 prognosis with PS matching, statin therapy confirmed its association with a more severe disease (NEWS ≥5 61% vs. 48%, p = 0.025) but not with in-hospital mortality (26% vs. 28%, p = 0.185). At univariate logistic regression analysis, statin use was confirmed not to be associated with mortality (OR 0.901; 95% CI: 0.537 to 1.51; p = 0.692) and to be associated with a more severe disease (NEWS≥5 OR 1.7; 95% CI 1.067-2.71; p = 0.026). CONCLUSIONS: Our results did not confirm the supposed favorable effects of statin therapy on COVID-19 outcomes. Conversely, they suggest that statin use should be considered as a proxy of underlying comorbidities, which indeed expose to increased risks of more severe COVID-19.

Use of the new rotating dilator sheath TightRail™ for lead extraction: A bicentric experience.

AIM: The aim of this study is to assess the safety and efficacy of the new bidirectional rotational mechanical sheath TightRail™ (Spectranetics) for lead extraction. METHODS AND RESULTS: This is a bicentric prospective study that included patients who underwent a transvenous lead extraction (TLE) in two Italian centers (San Raffaele Hospital and Humanitas Gavazzeni Hospital). From November 2016 to December 2018, 26 patients underwent a TLE procedure in which the TightRail™ was used. The new TightRail Sub-C was used in 20 (76%) patients to overcome the fibrosis between the vessel and the first rib. Median age was 69 (IQR 60.7-79.5) years. The indication for TLE were infection (57.7%) or lead dysfunction (42.3%). A total of 57 leads (range 1-4), 40 of which using the TightRail (range 1-4), were extracted. Overall mean implant duration was 98.2.0 ± 66.5 months. Mean age of the lead extracted with the TightRail sheath was 99.1 ± 70.2 months and was higher compared to that of the leads extracted manually (84.4 ± 60.3 months, P = .001). The overall clinical success was 100% and complete procedural success without the use of a snare was achieved in 98.3%. There were no cases of death or major complications and only two minor complications occurred. All patients were event-free at 6-month follow-up. CONCLUSION: This initial experience using the TightRail™ suggests a high safety and efficacy profile for extractions in a wide range of lead age.