Cardiac implantable electronic devices replacements in patients followed by remote monitoring during COVID-19 lockdown.

Aims: Following coronavirus disease (COVID-19) outbreak, the Italian government adopted strict rules of lockdown and social distancing. The aim of our study was to assess the admission rate for cardiac implantable electronic devices (CIEDs) replacement procedures in Campania, the 3rd-most-populous region of Italy, during COVID-19 lockdown. Methods and results: Data were sourced from 16 referral hospitals in Campania from 10 March to 4 May 2020 (lockdown period) and during the same period in 2019. We retrospectively evaluated consecutive patients hospitalized for CIEDs replacement procedures during the two observational periods. The number and type of CIEDs replacement procedures among patients followed by remote monitoring (RM), the admission rate, and the type of hospital admission between the two observational periods were compared. In total, 270 consecutive patients were hospitalized for CIEDs replacement procedures over the two observation periods. Overall CIEDs replacement procedures showed a reduction rate of 41.2% during COVID-19 lockdown. Patients were equally distributed for sex (P = 0.581), and both age [median 76 years (IQR: 68-83) vs. 79 years (IQR: 68-83); P = 0.497]. Cardiac implantable electronic devices replacement procedures in patients followed by RM significantly increased (IR: +211%; P < 0.001), mainly driven by the remarkable increase rate trend of both PM (IR: +475%; P < 0.001) and implantable cardiac defibrillator replacement procedures (IR: +67%, P = 0.01), during COVID-19 lockdown compared with 2019 timeframe. Conclusions: We showed a significant increase trend rate of replacement procedures among CIEDs patients followed by RM, suggesting the hypothesis of its increased use to closely monitoring and to optimize the hospital admission time during COVID-19 lockdown.

Effects of COVID-19 lockdown on arrhythmias in patients with implantable cardioverter-defibrillators in southern Italy.

Background: The effects of lockdown on non-COVID patients are varied and unexpected. The aim is to evaluate the burden of cardiac arrhythmias during a lockdown period because of COVID-19 pandemics in a population implanted with cardiac defibrillators and followed by remote monitoring. Methods: In this retrospective, multicentre cohort study, we included 574 remotely monitored implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) recipients implanted before January 1, 2019, at seven hospitals in the Campania region, comparing the burden of arrhythmias occurred during the lockdown period because of COVID-19 epidemics (from March 9 to May 1, 2020) with the arrhythmias burden of the corresponding period in 2019 (reference period). Data collection was performed through remote monitoring. Results: During the lockdown period, we observed ventricular tachyarrhythmias (ventricular tachycardia or fibrillation) in 25 (4.8%) patients while in seasonal reference period we documented ventricular tachyarrhythmias in 12 (2.3%) patients; the comparison between the periods is statistically significant (P < .04). Atrial arrhythmias were detected in 38 (8.2%) subjects during the lockdown period and in 24 (5.2%) during the reference period (P < .004). Conclusion: In seven hospitals in the Campania region, during the pandemic lockdown period, we observed a higher burden of arrhythmic events in ICD/CRT-D patients through device remote monitoring.

Ultra-high-density mapping to guide effective His-bundle pacing.

Permanent His bundle pacing is a physiological alternative to right ventricular pacing, resulting in a lower probability of pacing-induced cardiomyopathy and left ventricular ejection fraction deterioration. The combined use of UHD mapping systems allows precise and detailed information on the His bundle location, possibly providing more pacing option locations.

Effective nonapical left ventricular pacing with quadripolar leads for cardiac resynchronization therapy.

BACKGROUND: Current guidelines recommend avoiding apical left ventricular (LV) pacing for cardiac resynchronization therapy (CRT). AIMS: We investigated the feasibility of nonapical pacing with the current quadripolar LV lead technology. METHODS: We analyzed consecutive patients who received CRT with an LV quadripolar lead. The post--implantation position of each electrode of the LV lead was designated as basal, mid, or apical. The pacing capture threshold (PCT) and phrenic nerve stimulation (PNS) threshold were assessed for each electrode. RESULTS: We enrolled 168 patients. A total of 8 CRT defibrillators were from Biotronik (with Sentus OTW QP leads), 98 were from Boston Scientific (with 21 Acuity X4 Spiral and 77 Acuity X4 Straight leads), and 62 from St. Jude Medical (with Quartet leads). The median (interquartile range) number of electrodes at nonapical segments per patient was 3 (1-4) with Biotronik Sentus leads, 4 (3-4) with spiral -design Boston Scientific leads, 4 (3-4) with straight Boston Scientific leads, and 3 (3-4) with St. Jude Medical Quartet leads (P = 0.045). Three patients (38%) with Biotronik Sentus leads, 21 (100%) with spiral -design Boston Scientific leads, 69 (90%) with straight -design Boston Scientific leads, and 49 (79%) with St. Jude Medical Quartet leads (P <0.001) had at least 1 electrode located at nonapical segments linked with a PNS -PCT safety margin of more than 2 V. During the 6-month follow -up, PNS was detected in 4 patients and was eliminated with reprogramming. No significant changes in PCT were detected during follow -up. CONCLUSIONS: Quadripolar leads allowed nonapical pacing with acceptable electrical parameters in the majority of CRT recipients, although differences were found among the currently available devices.

Usefulness of Hemodynamic Device-Based Optimization in Heterogeneous Patients Implanted with Cardiac Resynchronization Therapy Defibrillator.

Optimization of the atrioventricular (AV) and interventricular (VV) timings of the CRT is the most supposed correctable variable to improve the rate of CRT responder. The aim of the present study has been to evaluate if there is a specific subgroup of patients who can actually benefit the most from a hemodynamic optimization of AV. This is a prospective, observational single-center study that enrolled consecutive patients with clinical indication for CRT; all patients were implanted with CRT-D devices with SonR technology, able to automatically adjust AV and VV delay on a weekly basis. Among 57 patients, 39 (69%) showed a LVESV reduction > 15%. The SonR was able to modify the pacing parameters, but an increase of left atrial diameter was associated to a reduced AV variability, suggesting that an impaired left atrial function could potentially reduce the ability of the SonR algorithm to adjust the correct timing of pacing. Graphical abstract Patients with respectively a high (A) and low (B) AV timing variability, among several parameters that could potentially influence the AV timing, only left atrial dimensions demonstrated a significant impact. In fact an increase of left atrial diameter was associated to a reduced AV variability, suggesting that an impaired left atrial function could potentially reduce the ability of the SonR algorithm to adjust the correct timing of pacing.

Clinical and economic impact of multipoint left ventricular pacing: A comparative analysis from the Italian registry on multipoint pacing in cardiac resynchronization therapy (IRON-MPP).

INTRODUCTION: Early evidence suggests that multipoint left ventricular pacing (MPP) may improve response to cardiac resynchronization therapy (CRT). It is unknown whether this benefit is sustained and cost-effective. We used real-world data to evaluate long-term impact of MPP-ON clinical status, heart failure hospitalizations (HFH) and costs. METHODS: The Italian registry on multipoint left ventricular pacing is a prospective, multicenter registry of patients implanted with MPP-enabled CRT devices. For this analysis, clinical and echocardiographic data were collected through 24 months and compared between patients with (MPP-ON) or without (MPP-OFF) early MPP activation at implant. The total cost of each HFH was estimated with national Italian reimbursement rates. RESULTS: The study included 190 MPP-OFF and 128 MPP-ON patients with similar baseline characteristics. At 1 and 2 years, the MPP-ON group had lower rates of HFH vs MPP-OFF (1-year hazard ratio [HR]: 0.14, P = .0014; 2-year HR: 0.38, P = .009). The finding persisted in a subgroup of patients with consistent MPP activation through follow-up (1-year HR: 0.19; P = .0061; 2-year HR: 0.39, P = .022). Total HFH per-patient costs were lower in the MPP-ON vs the MPP-OFF group at 1 year (€101 ± 50 vs €698 ± 195, P < .001) and 2 years (€366 ± 149 vs €801 ± 203, P = .038). More MPP-ON patients had ≥5% improvement in ejection fraction (76.8% vs 65.4%, P = .025) and clinical composite score (66.7% vs 47.5%, P = .01). CONCLUSIONS: In this multicenter clinical study, early MPP activation was associated with a significant reduction in cumulative HFH and related costs after 1 and 2 years of follow-up.

Electrical treatment of atrial arrhythmias in heart failure patients implanted with a dual defibrillator CRT device. Results from the TRADE-HF study.

BACKGROUND: Ventricular and atrial arrhythmias commonly occur in heart failure patients and are a significant source of symptoms, morbidity and mortality. Some specific generators referred to as dual defibrillators, Dual CRT-Ds, have the ability to treat atrial and ventricular arrhythmias. TRADE-HF is a prospective two-arm randomized study aimed at assessing the benefits of complete automatic management of atrial arrhythmias in patients implanted with a dual CRT-D. METHODS: Primary objective of the TRADE-HF study was to document reduction of unplanned hospital admission for cardiac reasons or death for cardiovascular causes or progression to permanent AF, by comparing fully-automatic device driven therapy for atrial tachycardia or fibrillation (AT/AF) to an in-hospital approach for treatment of symptomatic AT/AF. Randomized Patients were followed every 6months for 3years to assess the primary objective. RESULTS: Four-hundred-twenty patients have been enrolled in the study. At the end of the study 30 subjects died for cardiovascular causes, 60 had at least one hospitalization for cardiovascular causes and 14 developed permanent AF. Eighty-seven patients experienced a composite event. Hazard Ratio for device-managed automatic therapy arm compared to traditional was 0.987 (95% CI: 0.684-1.503; p=0.951). The primary endpoint analysis resulted in no difference between the device managed and in-hospital treatment arm. CONCLUSION: The TRADE-HF study failed to demonstrate a reduction in the composite of unplanned hospitalizations for cardiovascular causes or death for cardiovascular causes or progression to permanent AF using automatic atrial therapy compared to a traditional approach including hospitalization for symptomatic episodes and/or in-hospital treatment of AT/AF.

Work-related outcome after acute coronary syndrome: Implications of complex cardiac rehabilitation in occupational medicine.

OBJECTIVES: Coronary heart disease is frequent in the working-age population. Traditional outcomes, such as mortality and hospital readmission, are useful for evaluating prognosis. Fit-for-work is an emerging outcome with clinical as well as socioeconomic significance. We describe the possible benefit of a cardiac rehabilitation (CR) program for return to work (RTW) after acute coronary syndrome (ACS). MATERIAL AND METHODS: We evaluated 204 patients with recent ACS. They were divided into 4 groups on the basis of their occupational work load: very light (VL), light (L), moderate (M), and heavy (H). Work-related outcomes were assessed with the Work Performance Scale (WPS) of the Functional Status Questionnaire and as "days missed from work" (DMW) in the previous 4 weeks. The variables considered for outcomes were percent ejection fraction, functional capacity expressed in metabolic equivalents (METs), and participation or non-participation in the CR program (CR+ and CR-). RESULTS: One hundred thirty (66%) patients took part in the CR program. Total WPS scores for CR+ and CR- subgroups were VL group: 18±4 vs. 14±4 (p < 0.001), L group: 18±3 vs. 14±3 (p < 0.0001), M group: 19±3 vs. 16±3 (p < 0.003), and H group: 20±4 vs. 17±3 (p < 0.006). Fewer DMW were reported by the CR+ group. CONCLUSIONS: Non-participation in CR was a consistent cause of poorer work-related outcomes. Our findings indicate that CR and occupational counseling play a very important role in worker recovery and subsequent reintegration in the workplace, in particular among clerical workers.

The clinical benefit of cardiac resynchronization therapy optimization using a device-based hemodynamic sensor in a patient with dilated cardiomyopathy: a case report.

INTRODUCTION: Results on the evolution of the clinical status of patients undergoing cardiac resynchronization therapy with a defibrillator after automatic optimization of their cardiac resynchronization therapy are scarce. We observed a rapid and important change in the clinical status of our non-responding patient following activation of a sensor capable of weekly atrioventricular and interventricular delays' optimization. CASE PRESENTATION: A 78-year-old Caucasian man presented with dilated cardiomyopathy, left bundle branch block, a left ventricular ejection fraction of 35 %, New York Heart Association class III/IV heart failure, and paroxysmal atrial fibrillation. Our patient was implanted with a cardiac resynchronization device with a defibrillator and the SonRtip atrial lead. Right ventricular and left ventricular leads were also implanted. Because of the recurrence of atrial fibrillation, the automatic optimization was set off at discharge. Consequently, the device did not optimize atrioventricular and interventricular delays (programming at discharge: 125 ms for the atrioventricular delay and 0 ms for the interventriculardelay). Our patient was treated with an anti-arrhythmic drug. Five months after implantation, his clinical status remained impaired (left ventricular ejection fraction = 30 %). The SonR signal amplitude had also decreased from 0.52 g to 0.29 g. Nevertheless, because our patient was no longer presenting with atrial fibrillation, the anti-arrhythmic treatment was stopped and the SonR optimization system was activated. After 2 months of automatic cardiac resynchronization therapy with defibrillator optimization, our patient's clinical status had significantly improved (left ventricular ejection fraction = 60 %, New York Heart Association class II) and the SonR signal amplitude had doubled shortly after the first weekly automatic optimization. CONCLUSION: In this non-responding patient, device-based automatic cardiac resynchronization therapy optimization was shown to significantly improve his clinical status.

A novel fluoroscopic method of measuring right-to-left interlead distance as a predictor of reverse left ventricular remodeling after cardiac resynchronization therapy.

PURPOSE: In spite of technological breakthroughs, the choice of a suitable location for the coronary sinus (CS) lead in biventricular implants is still mostly empiric. The aim of this study was to investigate the utility of a radiological index-the distance between the right ventricular (RV) and CS lead tips on fluoroscopic recordings, measured by means of a new method-as a tool for selecting the most profitable left ventricular (LV) lead position. METHODS: Forty-nine consecutive patients (36 male, 13female; mean age 63 ± 19 year), in whom the LV electrode was implanted in a lateral/postero-lateral position in the CS, were evaluated immediately after implantation. The fluoroscopic distances between the RV and LV lead tips were calculated off-line in antero-posterior (2DAP) and latero-lateral (2DLL) projections by means of integrated software. RESULTS: On 1-year follow-up evaluation, 53 % patients were classed as responders (R) (>15 % reduction in LV end-systolic volume) and 47 % as non-responders (NR). On receiver-operating curve analysis, 2DAP and 2DLL showed cut-off values of 81 mm and 51 mm, respectively. In discriminating between R and NR, 2DAP >81 mm displayed 95 % specificity and 74 % sensitivity, while 2DLL >51 mm displayed 74 % specificity and 92 % sensitivity. On multivariate analysis, the cut-off values of 2DAP and 2DLL were significantly predictive of R to CRT. CONCLUSIONS: In our single-center prospective experience, RV-LV interlead distance measured by means of a novel method on fluorographic recordings correlated with CRT response. The use of this method as an intra-operative guide to identifying suitable lead placement in the CS needs evaluating on-line and on a large scale.

Separate origin of left anterior descending artery and left circumflex artery from left aortic sinus of Valsalva: visualization by multislice computed tomography before and after coronary artery bypass graft.

A 59-year-old woman was admitted to our hospital because of atypical chest pain. Stress ECG test was inconclusive. The patient underwent contrast-enhanced 16-slice computed tomography which demonstrated the absence of left main, and separate but adjacent ostia of the left anterior descending artery (LAD) and the left circumflex artery (CX) from the left coronary aortic sinus of Valsalva and severe narrowing of their proximal tracts. Conventional coronary angiography confirmed the diagnosis. Some time later, the patient underwent coronary artery bypass graft by left internal mammary artery graft to the LAD and Y-saphenous vein bypass to the obtuse marginal branch of CX. Multislice computed tomography (MSCT) scan, 1 year later, revealed the patency of grafts. MSCT, with the aid of postprocessing techniques, is an accurate and precise, noninvasive tool for the visualization of coronary artery anatomy, identification of coronary stenoses and evaluation of coronary artery bypass grafts.

Usefulness of multislice computed tomography to assess patency of coronary artery stents versus conventional coronary angiography.

BACKGROUND: The aim of the present study was to assess the in-stent restenosis and occlusion of coronary artery stents by multislice computed tomography (MSCT) compared with conventional coronary angiography in patients with atypical chest pain and not practicable/non-conclusive stress test. METHODS: Between December 2004 and March 2006, 81 patients were scheduled and of these 72 (65 men, mean age 61 years) with 90 stents underwent MSCT angiography using a 16-slice scanner, Toshiba Aquilion 16, 8-12 months after stent placement. RESULTS: Of the 90 stents, 71 (79%) could be assessed and 19 (21%) were excluded because the image quality at the stent level was incompatible with diagnostic assessment. This results in sensitivity, specificity, and positive and negative predictive values for all assessable stents in the identification of occlusion and/or in-stent restenosis of 82, 96, 87, and 94%, respectively. When the 19 uninterpretable stents were included in the analysis, the diagnostic accuracy of MSCT in detecting in-stent restenosis and occlusion resulted in a sensitivity of 82%, specificity of 71%, positive predictive value of 40%, and negative predictive value of 94%. CONCLUSION: The results of the study suggest that MSCT angiography is a useful method for evaluating patency/occlusion of large (>or=3 mm) coronary stents in symptomatic patients with atypical chest pain and concomitant not practicable/non-conclusive exercise or stress imaging test.