Closed Loop Stimulation reduces the incidence of atrial high-rate episodes compared to conventional rate-adaptive pacing in patients with sinus node dysfunctions.

BACKGROUND AND AIMS: Subclinical atrial fibrillation (AF) is associated with increased risk of progression to clinical AF, stroke, and cardiovascular death. We hypothesized that in pacemaker patients requiring dual-chamber rate-adaptive (DDDR) pacing, Closed Loop Stimulation (CLS) integrated into the circulatory control system through intracardiac impedance monitoring would reduce the occurrence of atrial high-rate episodes (AHREs) compared to conventional DDDR pacing. METHODS: Patients with sinus node dysfunctions (SND) and an implanted pacemaker or defibrillator were randomly allocated to dual-chamber CLS (n=612) or accelerometer-based DDDR pacing (n=598) and followed for 3 years. The primary endpoint was time to the composite endpoint of first AHRE lasting ≥6 minutes, stroke, or transient ischemic attack (TIA). All AHREs were independently adjudicated using intracardiac electrograms. RESULTS: The incidence of the primary endpoint was lower in the CLS arm (50.6%) than in the DDDR arm (55.7%), primarily due to the reduction in AHREs lasting between 6 hours and 7 days. Unadjusted site-stratified hazard ratio (HR) for CLS versus DDDR was 0.84 (95%-CI, 0.72-0.99; p=0.035). After adjusting for CHA2DS2-VASc score, the HR remained 0.84 (95%-CI, 0.71-0.99; p=0.033). In subgroup analyses, the incremental benefit of CLS was greatest in patients without atrioventricular block (HR, 0.76; p=0.006) and in patients without AF history (HR, 0.73; p=0.010). The contribution of stroke/TIA to the primary endpoint (1.3%) was low and not statistically different between study arms. CONCLUSIONS: Dual-chamber CLS in patients with SND is associated with a significantly lower AHRE incidence than conventional DDDR pacing.

Short-duration head-up tilt test potentiated with sublingual nitroglycerin in suspected vasovagal syncope: the fast Italian protocol.

BACKGROUND: The traditional nitroglycerin (NTG) head-up tilt test (HUTT) is time-consuming and the test duration is a barrier to widespread utilization in clinical practice. It was hypothesized that a short-duration protocol is not inferior to the traditional protocol regarding the positivity rate and has a similar distribution of hemodynamic response. METHODS AND RESULTS: Patients undergoing HUTT were randomized 1:1 to a 10 min passive phase plus a 10 min 0.3 mg NTG if the passive phase was negative (Fast) or to a 20 min passive phase plus a 15 min 0.3 mg NTG if the passive phase was negative (Traditional). A sample size of 277 patients for each group achieved 80% power to detect an expected difference of 0% with a non-inferiority margin of -10% using a one-sided t-test and assuming a significant level alpha of 0.025. A total of 554 consecutive patients (mean age 46.6 ± 19.3 years, 47.6% males) undergoing HUTT for suspected vasovagal syncope were randomly assigned to the Fast (n = 277) or Traditional (n = 277) protocol. A positive response was defined as the induction of syncope in presence of hypotension/bradycardia, and was observed in 167 (60.3%) patients with Fast and in 162 (58.5%) patients with the Traditional protocol. There was a trend of lesser vasodepressor response (14.8% Fast vs. 20.6% Traditional) which was significant during the passive phase (P = 0.01). CONCLUSION: The diagnostic value of the Fast HUTT protocol is similar to that of the Traditional protocol and therefore the Fast protocol can be used instead of the Traditional protocol.

Outcomes of transvenous lead extraction in octogenarians using bidirectional rotational mechanical sheaths.

BACKGROUND: Outcomes of transvenous lead extraction (TLE) are well reported in the general population, However, data on safety, efficacy of TLE in octogenarians with a long lead dwell time, using powered extraction tools are limited. The aim of this multicenter study was to evaluate the safety, effectiveness of TLE in octogenarians using the bidirectional rotational mechanical sheaths and mid-term outcome after TLE. METHODS: The study population comprised 83 patients (78.3% male; mean age 85 ± 3 years; [range 80-94 years]) with 181 target leads. All the leads (mean implant duration 112 ± 77 months [range 12-377]) were extracted exclusively using the Evolution RL sheaths (Cook Medical, Bloomington, IN, USA). RESULTS: The main indication for TLE was infection in 84.3% of cases. Complete procedural success rate, clinical success rate, per lead were 93.9% and 98.3%, respectively. Failure of lead extraction was seen in 1.7% of leads. The additional use of a snare was required in 8.4% of patients. Major complications occurred in one patient (1.2%). Thirty-day mortality after TLE was 6%. During a mean time follow-up of 22 ± 21 months, 24 patients (29%) died. No procedure-related mortality occurred. Predictors of mortality included ischemic cardiomyopathy (HR 4.35; 95% CI 1.87-10.13; p = .001), left ventricularejection fraction ≤35% (HR 7.89; 95% CI 3.20-19.48; p < .001), and TLE for systemic infection (HR 4.24; 95% CI 1.69-10.66; p = .002). CONCLUSIONS: At experienced centers bidirectional rotational mechanical sheaths combined with different mechanical tools and femoral approach allowreasonable success and safety in octogenarian with long lead dwell time. Patient's age should not influence the decision to extract or not the leads, although the 30-day and mid-term mortality are significant, especially in the present of specific comorbidities.

Outcomes of transvenous lead extraction of very old leads using bidirectional rotational mechanical sheaths: Results of a multicentre study.

INTRODUCTION: Lead dwell time >10 years is a recognized predictor for transvenous lead extraction (TLE) failure and complications. Data on the efficacy and safety of TLE using the bidirectional rotational mechanical sheaths in patients with very old leads are lacking. In this multicenter study, we reported the outcomes of transvenous rotational mechanical lead extraction in patients with leads implanted for ≥10 years. METHODS: A total of 441 leads (median: 159 months [135-197]; range: 120-487) in 189 consecutive patients were removed with the Evolution RL sheaths (Cook Medical, Bloomingtom, IN, USA) and mechanical ancillary tools supporting the procedures. RESULTS: The main indication for TLE was infection in 74% of cases. Complete procedural success rate, clinical success rate, per lead were 94.8% and 98.2%, respectively. Failure of lead extraction was seen in 1.8% of leads. The additional use of a snare via the femoral approach was required in 9% of patients. Lead dwell time was the only predictor of incomplete led removal (odds ratio: 1.009; 95% confidence interval [CI]: 1.003-1.014; p = .002). Four major complication (2%) were encountered. During a mean time follow-up of 31 ± 27 months, 21 patients (11%) died. No procedure-related mortality occurred. Predictors of mortality included severe left ventricular systolic dysfunction (hazard ratio [HR]: 8.06; 95% CI: 2.99-21.73; p = .001), TLE for infection (HR: 8.0; 95% CI: 1.04-62.5; p = .045), diabetes (HR: 3.7; 95% CI: 1.48-9.5; p = .005), and previous systemic infection (HR: 3.1; 95% CI: 1.17-8.24; p = .022). Incomplete lead removal or failure lead extraction did not impact on survival during follow-up. CONCLUSION: Our findings demonstrated that the use of bidirectional rotational TLE mechanical sheaths combined with different mechanical tools and femoral approach allows reasonable success and safety in patients with very old leads at experienced specialized centers.

Removal of an active fixation coronary sinus pacing lead 5 years postimplant: A case report.

Active fixation for a lead in the coronary sinus may be essential to select the optimal left ventricular pacing site, maximize the effectiveness of cardiac resynchronization therapy (CRT) and avoid dislodgement. The Medtronic Attain Stability lead allows fixation through a side helix concentric with the lead body. Although electrical performance of such a lead is well known, evidence of extractability remains poor especially in the long term. We describe the removal of an Attain Stability lead 63 months after implantation which, to the best of our knowledge, is the longest implant duration that has ever been reported, in an 81-year-old male patient. It was successfully achieved using simple traction and rotation maneuvers, demonstrating the long-term removal feasibility of such device.

Inadvertent left ventricular placement of ICD lead through the left subclavian artery right positioned in a patient with situs viscerum inversus and Kartagener syndrome.

Inadvertent placement of pacemaker and implantable cardioverter-defibrillator (ICD) leads in the left ventricle is a rare but well-recognized complication of device implantation. We report a case of an unicameral ICD lead inadvertently placed through the left subclavian artery right positioned, across the aortic valve into the left ventricle, in a patient with situs viscerum inversus. A transthoracic echocardiogram about a month after the procedure showed an unusual course of the lead. The lead was successfully removed without complications or sequelae. .

Remote assessment of QT interval: A new perspective for implantable cardiac monitors.

BACKGROUND: There is an unmet need for simple tools for monitoring QT intervals. The feasibility of measuring the QT interval on the single­lead subcutaneous electrocardiogram (subECG) recorded and transmitted by implantable cardiac monitors (ICMs) has never been tested. METHODS: We performed a standard ECG in patients who had already been implanted with a long sensing vector ICM (BIOMONITOR, Biotronik SE&Co.) to calculate the corrected QT interval in lead II (QTc ECG). The QTc was then evaluated on the subECG provided by ICM both by using the programmer printout (QTc subECG) and the snapshot transmitted via home monitoring (QTc HM). Values were compared with Bland-Altman analyses. RESULTS: The study cohort consisted of 23 ICM recipients (age 58 ± 19 years, 35% female) implanted mainly for unexplained syncope (78%). The mean QTc ECG interval was 404 ± 31 ms. The T-wave was visible and QTc could be calculated in all patients using the ICM programmer printout and in 21 (91%) patients remotely. The QTc subECG and QTc HM were 405 ± 34 and 406 ± 32 ms. Compared to the QTc ECG, Bland-Altman analyses revealed a bias of -0.9 (95% confidence interval: -6.8/4.9) ms and 0.1 (-12.7/12.9) ms for QTc subECG and QTc HM, respectively. CONCLUSIONS: The QTc interval can be reliably estimated on in-person and remote subECG in most patients without bias compared to the ECG lead II assessment. This technology has the potential to facilitate remote QT interval monitoring.

Theophylline in patients with syncope without prodrome, normal heart, and normal electrocardiogram: a propensity-score matched study verified by implantable cardiac monitor.

AIMS: Syncope without prodromes in subjects with normal heart and normal electrocardiogram (ECG) is classified as non-classical neurally mediated syncope and is characterized by low adenosine plasma levels (APLs) and frequent asystolic syncope. We assessed the efficacy of theophylline, a non-selective adenosine receptor antagonist, in preventing syncopal events. METHODS AND RESULTS: Participants received an implantable cardiac monitor, underwent APL measurement, and received oral theophylline at maximum tolerated dose (starting dose 300 mg b.i.d.). They were compared with a historical cohort of untreated patients with implantable cardiac monitor who had the same inclusion criteria and were balanced with the propensity score (PS) method as regard age, sex, lifetime syncopal episodes, APL, and antihypertensive drugs. Primary endpoint was time to first syncopal recurrence at 24 months. There were 76 patients in the theophylline group and 58 in the control group. Syncope recurred in 25 (33%) patients in the theophylline group and in 27 (47%) patients in the control group, with an estimated 2-year recurrence rate of 33% and 60%, respectively, and a hazard ratio of 0.53 [95% confidence interval (CI), 0.30-0.95; P = 0.034]. Most of the benefit of theophylline is derived from reduction of syncope due to asystolic atrioventricular (AV) block (hazard ratio of 0.13; 95% CI, 0.03-0.58; P = 0.008). Thirty (39%) patients discontinued theophylline after a median of 6.4 (interquartile range 1.7-13.8) months due to side effects. CONCLUSION: Theophylline was effective in preventing recurrences in patients with syncope without prodromes, normal heart, and normal ECG. The benefit was greater in patients with syncope due to asystolic AV block. CLINICALTRIALS.GOV IDENTIFIER: NCT03803215.

The Impact of COVID-19 Outbreak on Syncope Units Activities in Italy: A Report from the Italian Multidisciplinary Working Group on Syncope (GIMSI).

The aim of our study was to evaluate the impact of the COVID-19 outbreak on Syncope Units (SUs) Activities in Italy. Methods: Data about types of SU activities and admissions were obtained from 10 SUs throughout Italy, certified by the Italian Multidisciplinary Working Group on Syncope (GIMSI), from 10 March 2020 to 31 December 2020 and compared with the same time frame in 2019. Results: A remarkable reduction in overall non-invasive diagnostic tests (-67%; p < 0.001) and cardiac invasive procedure. Elective cardiac pacing procedures disclosed a significant decrease (-62.7%; p < 0.001); conversely, the decrease of urgent procedures was not significant (-50%; p = 0.08). There was a significantly increased rate of patients who underwent both telemedicine follow-up visits (+225%, p < 0.001) and cardiac implantable electronic devices (CIEDs) remote monitoring follow-up visits (+100%; p < 0.001). Conclusion: The COVID-19 outbreak was associated with a remarkable decrease in all clinical activities of Syncope Units in Italy, including both non-invasive tests and cardiac invasive procedures; conversely, a significant increase in telehealth activities was shown.

Cardiac Involvement in COVID-19 Patients: A Contemporary Review.

Background: The widely variable clinical manifestations of SARS-CoV2 disease (COVID-19) range from asymptomatic infections to multiple organ failure and death. Among the organs affected is the heart. This does not only affect people who already have previous cardiovascular problems, but also healthy people. This is a reason not to overlook any symptoms or to perform targeted examinations, even if apparently unrelated to the heart, for quick recognition and timely therapy. Aim of the study: This review recapitulates the current state of knowledge on the potential mechanisms and manifestation of myocarditis in patients with COVID-19 infection. Methods: A web-based search of published data was performed for all relevant studies on patients diagnosed with a COVID-19-induced acute myocarditis, and a total of 50 reports were included. The analysis of the studies evaluated highlights a male predominance, with the average age of patients being 55 years. The most common presenting symptoms included fever, shortness of breath, cough, and chest pain. Among ECG changes, non-specific ST-segment and T-wave amplitude alterations and ventricular tachycardia episodes were reported. Finally, we wanted to use a general evaluation without distinguishing between various countries, taking into consideration only the peer or reviewer, regardless of the declared value of the journals that have been published. Results and critical findings: The most common presenting symptoms included fever, shortness of breath, cough, and chest pain. Among ECG changes, non-specific ST-segment and T-wave amplitude alterations and ventricular tachycardia episodes were reported. In most patients, elevated levels of cardiac and inflammatory biomarkers were measured. Left ventricular dysfunction and hypokinesis were commonly exhibited symptoms. Cardiac Magnetic Resonance Imaging (CMRI) confirmed the diagnosis of myocarditis with features of cardiac edema and cardiac injury. Nine patients underwent histopathological examination. Treatment with corticosteroids and immunoglobulins was the most applied strategy following the administration of antivirals. Discussion: Despite the exponentially growing knowledge on the management of COVID-19 infection, current available data on SARS-CoV2-correlated myocarditis are still limited, and several difficulties may be encountered in the differential diagnosis of acute myocarditis in the context of COVID-19 disease. Conclusions: While diagnostic criteria and evaluation strategies for myocarditis are well described, no guidelines for the diagnosis and treatment of myocarditis in COVID-19 patients have yet been established. Therefore, further research is needed to advance the understanding of this disease process and define the most appropriate strategic approach in these patients.

Dalbavancin Efficacy and Impact on Hospital Length-of-Stay and Treatment Costs in Different Gram-Positive Bacterial Infections.

BACKGROUND AND OBJECTIVES: The study aimed to evaluate the impact of dalbavancin therapy on both hospital length-of-stay (LOS) and treatment-related costs, as well as to describe the clinical outcome, in a retrospective cohort of patients with diverse Gram-positive bacterial infections, hospitalized in different specialty Units. METHODS: From July 2017 to July 2019, clinical and sociodemographic data were collected for all hospitalized patients switched to dalbavancin for the treatment of Gram-positive infections. LOS and treatment-related costs were assessed and compared to a hypothetical scenario where the initial standard antimicrobial therapy would have been administered in hospital for the same duration as dalbavancin. RESULTS: A total of 50 patients were enrolled. The observed infections were: acute bacterial skin and skin structure infections (ABSSSIs, 12 patients), complicated ABSSSIs (eight patients), osteoarticular infections (18 patients), vascular graft or cardiovascular implantable electronic devices (CIED) infections (12 patients). After a median of 14 [interquartile range (IQR) 7-28] days, the in-hospital antimicrobial therapy was switched to dalbavancin 1500 mg. When appropriate, considering the site and the clinical course of the infection, 1500 mg doses were repeated every 14 days until recovery. Overall, 49/50 (98%) patients reported clinical success at the end of therapy. No relapses were observed in 37 patients for whom a median follow-up of 150 (IQR 30-180) days was available. By switching to dalbavancin, a median of €8,259 (IQR 5644-17,270) and 14 hospital days (IQR 22-47) per patient were saved. CONCLUSIONS: In this experience, the use of dalbavancin contributed to shorten LOS and treatment-related costs, especially in difficult Gram-positive infections requiring prolonged therapy.

The human coronaviruses (HCoVs) and the molecular mechanisms of SARS-CoV-2 infection.

In humans, coronaviruses can cause infections of the respiratory system, with damage of varying severity depending on the virus examined: ranging from mild-to-moderate upper respiratory tract diseases, such as the common cold, pneumonia, severe acute respiratory syndrome, kidney failure, and even death. Human coronaviruses known to date, common throughout the world, are seven. The most common-and least harmful-ones were discovered in the 1960s and cause a common cold. Others, more dangerous, identified in the early 2000s and cause more severe respiratory tract infections. Among these the SARS-CoV, isolated in 2003 and responsible for the severe acute respiratory syndrome (the so-called SARS), which appeared in China in November 2002, the coronavirus 2012 (2012-nCoV) cause of the Middle Eastern respiratory syndrome (MERS) from coronavirus, which exploded in June 2012 in Saudi Arabia, and actually SARS-CoV-2. On December 31, 2019, a new coronavirus strain was reported in Wuhan, China, identified as a new coronavirus beta strain ß-CoV from group 2B, with a genetic similarity of approximately 70% to SARS-CoV, the virus responsible of SARS. In the first half of February, the International Committee on Taxonomy of Viruses (ICTV), in charge of the designation and naming of the viruses (i.e., species, genus, family, etc.), thus definitively named the new coronavirus as SARS-CoV-2. This article highlights the main knowledge we have about the biomolecular and pathophysiologic mechanisms of SARS-CoV-2.

Usefulness of 18F-FDG PET/CT in Patients with Cardiac Implantable Electronic Device Suspected of Late Infection.

The presence of a cardiovascular implantable electronic device (CIED) can be burdened by complications such as late infections that are associated with significant morbidity and mortality and require immediate and effective treatment. The aim of this study was to evaluate the role of 18F-fluorodeoxyglucose positron-emission tomography/computed tomography (18F-FDG PET/CT) in patients with suspected CIED infection. Fifteen patients who performed a 18F-FDG PET/CT for suspicion of CIED infection were retrospectively analyzed; 15 patients, with CIED, that underwent 18F-FDG PET/CT for oncological reasons, were also evaluated. Visual qualitative analysis and semi-quantitative analysis were performed. All patients underwent standard clinical management regardless 18F-FDG PET/CT results. Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) resulted as 90.91%, 75%, 86.67%, 90.91% and 75% respectively. Maximum standardized uptake values (SUVmax) and semi-quantitative ratio (SQR) were collected and showed differences statistically significant between CIED infected patients and those who were not. Exploratory cut-off values were derived from receiver operating characteristic (ROC) curves for SUVmax (2.56) and SQR (4.15). This study suggests the clinical usefulness of 18F-FDG PET/CT in patients with CIED infection due to its high sensitivity, repeatability and non-invasiveness. It can help the clinicians in decision making, especially in patients with doubtful clinical presentation. Future large-scale and multicentric studies should be conducted to establish precise protocols about 18F-FDG PET/CT performance.

What we have learned for the future about COVID-19 and healthcare management of it?

BACKGROUND AND AIM OF THE WORK: COVID-19 is a current global pandemic. However, comprehensive global data analyses for its healthcare management are lacking. METHODS: In this study we have researched through published scientific articles and international health care  guidelines to find out actually about our knowledge for this new pandemic from SARS-CoV-2 and related COVID-19 disease that emerged from December 2019 in China in order to better manage this health emergency. RESULTS: The pathogens represented by microorganisms (bacteria, mycetes or viruses) show their effect after days and are responsible for epidemics/pandemics as dangerous as the greater their possibility of transmission, especially by inhalation, and therefore their infectivity. CONCLUSIONS: The appearance of new pathogenic viruses for humans such as the COVID -19, which previously were found only in the animal world occurs through the spillover (is the third documented of an animal coronavirus to humans), it is thought that it could also be the same also for the origin of this virus. Furthermore, the trend of this pandemic in one of the countries most affected by Italy after China was also considered.

Multicenter experience with the Evolution RL mechanical sheath for lead extraction using a stepwise approach: Safety, effectiveness, and outcome.

BACKGROUND: In addition to the Evolution RL sheath, tools by Cook Medical (Bloomington, IN, USA), supporting lead extraction (LE), are available. Data on their use are not reported in detail in previous studies. Moreover, data regarding outcome are lacking. The aim was to evaluate the safety and effectiveness of the Evolution sheath (Evolution RL and Evolution Shortie, Cook Medical) by using a stepwise approach with the available extraction tools and the outcome. METHODS: A total of 393 leads in 198 consecutive patients were removed with the Evolution RL sheath and ancillary tools using a stepwise approach. RESULTS: The main indication for LE was infection in 125 (63.1%) cases. The mean implant duration was 95.4 ± 59.7 months. According to our stepwise approach, the Evolution Shortie RL sheath was used in all cases and complete LE was achieved in 24 (12.2%) cases. The Evolution RL was used in 174 (87.8%) cases and the SteadySheath Evolution tissue stabilization sheath (Cook Medical) in 87 (44%) because of tenacious fibrosis anchored targeted leads. Compression coil (OneTie, Cook Medical) was used in 141 (71%) cases. Complete procedural success rate, clinical success rate, and lead removal with clinical success rate were 97%, 99%, and 99.5%, respectively. One major complication (0.5%) and 10 (5%) minor complications were encountered. During a mean time follow-up of 12 ± 9 months, 14 (7%) patients died. Predictors of mortality included impaired renal function (HR 5.7; 95% CI 1.9-17.6; P = 0.002), extraction because of infection (hazard ratio [HR] 4.0; 95% confidence interval [CI] 1-18.1; P = 0.045), and diabetes (HR 3.2; 95% CI 1.1-9.8; P = 0.036). CONCLUSIONS: Lead extraction using the Evolution RL bidirectional rotational mechanical sheath and ancillary tools in a systematic stepwise approach was effective and safe.

Head-to-head comparison of peak upright bicycle and post-treadmill echocardiography in detecting coronary artery disease: a randomized, single-blind crossover study.

BACKGROUND: Post-treadmill digital echocardiography (post-TME) is the most widely used form of exercise echocardiography, but ischemia can rapidly resolve in the postexercise period; peak upright bicycle digital echocardiography (UBE) has the advantage of providing images at peak exercise that reflect normal physiology. However, the comparative accuracy of the two methods in detecting ischemia in the same patients is unknown. To compare the relative diagnostic value of peak UBE and post-TME in detecting coronary artery disease, both tests were performed in 86 consecutive patients undergoing coronary angiography. METHODS: Eighty-six patients referred for evaluation of coronary disease underwent peak UBE (starting at 25 W, with 25-W increments every 3 min) and post-TME (Bruce protocol) in a random sequence. Digitized images of peak UBE and post-TME were interpreted in a random and blinded fashion. RESULTS: More transient wall motion abnormalities were detected with peak UBE than post-TME (55 vs 42, P < .001), and such exercise-induced wall motion abnormalities were more extensive (5.5 ± 3.0 vs 3.4 ± 2.1 dyskinetic segments, P < .001) and more severe (regional wall motion score index, 2.7 ± 0.5 vs 2.5 ± 0.5; P = .003). By angiography, 59 patients had coronary artery disease (a coronary stenosis of ≥50% diameter narrowing); the sensitivity of peak UBE for detecting coronary artery disease was greater than that of post-TME in the population as a whole (88% vs 66%, P < .01) and in the single-vessel subgroup (72% vs 44%, P < .05), with no worsening in specificity (89% vs 89%, P = NS). CONCLUSIONS: Peak UBE is more capable of detecting ischemia than post-TME, and this is achieved with no worsening of specificity. Thus, peak UBE should be preferred in patients able to perform bicycle exercise.