Publications by authors named "Paolo De Filippo"

36 Publications

Challenges in remote monitoring of cardiac implantable electronic devices in 2021.

Kardiol Pol 2021 Mar 26. Epub 2021 Mar 26.

Patients with cardiac implantable electronic devices (CIEDs) have been usually scheduled for routine in hospital visits, in addition they are now monitored remotely. Remote monitoring of CIEDs is a valuable tool to screen and triage patients at very high risk of deterioration. The continuous expansion of remote monitoring in real world brought a substantial increase of published evidence about the topic; therefore, this review aims to summarize residual challenges and gaps of knowledge in the field. Challenges that were identified to be solved comprise warranty of data security and accessibility, integration with clinical repositories, patients' selection and persistence, and resources availability. Future improvements of telemedicine will need to face with these important residual challenges.
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http://dx.doi.org/10.33963/KP.15899DOI Listing
March 2021

Elective replacement of a 4-year-old leadless pacemaker: New approach for end-of-life management.

J Cardiovasc Electrophysiol 2021 Apr 18;32(4):1171-1173. Epub 2021 Feb 18.

Cardiac Electrophysiology and Pacing Unit, ASST Papa Giovanni XXIII, Bergamo, Italy.

We report the first case of new technique of replacement of a Micra TPS, due to battery depletion. A 38-year-old patient was admitted due to battery depletion of a TPS, after 44 months of regular pacemaker functioning. After routine implantation of a new TPS, we use a snare loop inserted in the delivery system to capture the old TPS. We believe this approach a good option not to abandon the depleted device, to avoid possible electrical interference or space occupation in right ventricle. This new approach allows to change the strategy during procedure and does not increase significantly the procedure costs.
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http://dx.doi.org/10.1111/jce.14946DOI Listing
April 2021

Worldwide Survey of COVID-19-Associated Arrhythmias.

Circ Arrhythm Electrophysiol 2021 03 7;14(3):e009458. Epub 2021 Feb 7.

Department of Medicine, Division of Cardiology, Columbia University Vagelos College of Physicians & Surgeons (E.J.C., S. Kochav, I.G., A.B., H.G., E.Y.W.).

[Figure: see text].
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http://dx.doi.org/10.1161/CIRCEP.120.009458DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7982128PMC
March 2021

Pediatric catheter ablation at the beginning of the 21st century: results from the European Multicenter Pediatric Catheter Ablation Registry 'EUROPA'.

Europace 2021 Mar;23(3):431-440

Unita di Elettrofisiologia ed Elettrostimolazione Cardiaca, Ospedale Papa Giovanni XXIII, Bergamo, 24127, Italy.

Aims: Contemporary data from prospective multicentre registries on catheter ablation in pediatric patients are sparse. Aim of the European Pediatric Catheter Ablation Registry EUROPA was to contribute data to fill this gap of knowledge.

Methods And Results: From July 2012 to June 2017, data on catheter ablation in pediatric patients (≤18 years of age) including a 1-year follow-up from five European pediatric EP centres were collected prospectively. A total of 683 patients (mean age 12.4 ± 3.9 years, mean body weight 50.2 ± 19 kg) were enrolled. Target tachycardia was WPW/atrioventricular-nodal re-entrant tachycardia (AVRT) in 380 (55.7%) patients, AVNRT in 230 (33.8%) patients, ventricular tachycardia (VT) in 24 (3.5) patients, focal atrial tachycardia (FAT) in 20 (2.9%) patients, IART in 14 (2%) patients, and junctional ectopic tachycardia in 3 (0.45) patients. Overall procedural success was 95.6%. Compared with all other substrates, success was significantly lower in FAT patients (80%, n = 16, P = 0.001). Mean procedure duration was 136 ± 67 min and mean fluoroscopy time was 4.9 ± 6.8 min. Major complications occurred in 0.7% of the patients. No persisting AV block requiring permanent pacing was reported. At 1-year follow-up (605/683 patients, 95%), tachycardia recurrence was reported in 7.8% of patients. Recurrence after VT ablation (33%) was significantly higher (P = 0.001) than after ablation of all other substrates.

Conclusion: The present study proves overall high efficacy and safety of catheter ablation of various tachycardia substrates in pediatric patients. Of note, complication rate was exceptionally low. Long-term success was high except for patients after VT ablation.
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http://dx.doi.org/10.1093/europace/euaa325DOI Listing
March 2021

Implantation technique and optimal subcutaneous defibrillator chest position: a PRAETORIAN score-based study.

Europace 2020 12;22(12):1822-1829

Department of Experimental, Diagnostic and Specialty Medicine, Institute of Cardiology, University of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy.

Aims: The traditional technique for subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation involves three incisions and a subcutaneous pocket. Recently, a two-incision and intermuscular (IM) technique has been adopted. The PRAETORIAN score is a chest radiograph-based tool that predicts S-ICD conversion testing. We assessed whether the S-ICD implantation technique affects optimal position of the defibrillation system according to the PRAETORIAN score.

Methods And Results: We analysed consecutive patients undergoing S-ICD implantation. The χ2 test and regression analysis were used to determine the association between the PRAETORIAN score and implantation technique. Two hundred and thirteen patients were enrolled. The S-ICD generator was positioned in an IM pocket in 174 patients (81.7%) and the two-incision approach was adopted in 199 (93.4%). According to the PRAETORIAN score, the risk of conversion failure was classified as low in 198 patients (93.0%), intermediate in 13 (6.1%), and high in 2 (0.9%). Patients undergoing the two-incision and IM technique were more likely to have a low (<90) PRAETORIAN score than those undergoing the three-incision and subcutaneous technique (two-incision: 94.0% vs. three-incision: 78.6%; P = 0.004 and IM: 96.0% vs. subcutaneous: 79.5%; P = 0.001). Intermuscular plus two-incision technique was associated with a low-risk PRAETORIAN score (hazard ratio 3.76; 95% confidence interval 1.01-14.02; P = 0.04). Shock impedance was lower in PRAETORIAN low-risk patients than in intermediate-/high-risk categories (66 vs. 96 Ohm; P = 0.001). The PRAETORIAN score did not predict shock failure at 65 J.

Conclusion: In this cohort of S-ICD recipients, combining the two-incision technique and IM generator implantation yielded the lowest PRAETORIAN score values, indicating optimal defibrillation system position.

Clinical Trial Registration: http://clinicaltrials.gov/ Identifier: NCT02275637.
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http://dx.doi.org/10.1093/europace/euaa231DOI Listing
December 2020

[Grey zones on new oral anticoagulants in atrial fibrillation. Expert opinion].

G Ital Cardiol (Rome) 2020 Feb;21(2):103-110

Dipartimento di Cardiologia, Azienda Ospedaliera "Brotzu", Cagliari.

Clinical guidelines, while representing an objective reference to perform appropriate treatment choices, contain grey zones, where recommendations are not supported by solid evidence. In a conference held in Bergamo in October 2018, an attempt was made to highlight some of the main grey zones in Cardiology and, through a comparison between experts, to draw shared conclusions that can illuminate our clinical practice. This manuscript contains the statements of the symposium concerning the controversies regarding new oral anticoagulants (NOACs) and atrial fibrillation (AF). The manuscript represents the organization of the meeting, with an initial review of current guidelines on this topic, followed by an expert presentation of pros (white) and cons (black) related to the identified "gaps of evidence". For every issue is then reported the response derived from the votes of the experts and the public, the discussion and, finally, the highlights, which are intended as practical "take home messages" to be used in everyday clinical practice. The first topic concerns the indication for anticoagulant therapy in patients with subclinical AF revealed by implanted devices. The second issue examines the opportunity to use NOACs in oncological patients with AF. The third gap evaluates the necessity of anticoagulating patients with AF and CHA2DS2-VASc 1 or CHA2DS2-VASc 2 if women. The last "gap in evidence" concerns the preference of triple or double therapy in patients with AF and acute coronary syndrome/coronary stenting. The work has also been implemented with evidences deriving from important randomized studies published after the date of the Conference.
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http://dx.doi.org/10.1714/3300.32703DOI Listing
February 2020

Real-life outcome of implantable cardioverter-defibrillator and cardiac resynchronization defibrillator replacement/upgrade in a contemporary population: observations from the multicentre DECODE registry.

Europace 2019 Oct;21(10):1527-1536

Azienda Ospedaliero-Universitaria di Bologna, Via Massarenti n. 9, Bologna, Italy.

Aims: The benefit of prolonged implantable cardioverter-defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) therapy following device replacement is hindered by clinical and procedure-related adverse events (AEs). Adverse events rate is highest in more complex devices and at upgrades, as per the REPLACE registry experience, but is changing owing to the improvement in device technology and medical care. We aimed at understanding the extent and type of AEs in a contemporary Italian population.

Methods And Results: Detect long-term complications after ICD replacement (DECODE) was a prospective, single-arm, multicentre cohort study aimed at estimating medium- to long-term AEs in a large population of patients undergoing ICD/cardiac resynchronization defibrillator replacement/upgrade from 2013 to 2015. We prospectively analysed all clinical and device-related AEs at 12-month follow-up (FU) of 983 consecutive patients (median age 71 years, 76% male, 55% ischaemic, 47% CRT-D) followed for 353 ± 49 days. Seven percent of the patients died (60.6% for cardiovascular reasons), whereas 104 AEs occurred; 43 (4.4%) patients needed at least one surgical action to treat the AE. Adverse events rates were 3.3/100 years lead-related, 3.4/100 years bleedings, and 1.6/100 years infective. The primary endpoint was predicted by hospitalization in the month prior to the procedure [hazard ratio (HR) = 2.23, 1.16-4.29; 0.0169] and by upgrade (HR = 1.75, 1.02-2.99, 0.0441). One hundred and twelve (11.4%) patients met the combined endpoint of death from any cause, cardiac implantable electronic device (CIED)-related infection, and surgical action/hospitalization required to treat the AE. Hospitalization within 30 days prior to the procedure (HR = 2.07, 1.13-3.81; 0.0199), anticoagulation (HR = 1.97, 1.26-3.07; 0.003), and ischaemic cardiomyopathy (HR = 1.67, 95% confidence interval 1.06-2.63; P = 0.0276) were associated with the combined endpoint during FU.

Conclusions: Adverse events following CIED replacement/upgrade are lower than previously reported, possibly owing to improved patients care. Hospitalization in the month prior to the procedure, upgrade, and clinical profile (anticoagulation, ischaemic cardiomyopathy) hint to increased risk, suggesting an individualized planning of the procedure to minimize overall AEs.

Clinical Trial Registration: URL: http://clinicaltrials.gov/ Identifier: NCT02076789.
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http://dx.doi.org/10.1093/europace/euz166DOI Listing
October 2019

Time to therapy delivery and effectiveness of the subcutaneous implantable cardioverter-defibrillator.

Heart Rhythm 2019 10 29;16(10):1531-1537. Epub 2019 May 29.

Institute of Cardiology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Policlinico S.Orsola-Malpighi, Bologna, Italy.

Background: At the time of subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation, successful termination of ventricular fibrillation (VF) is confirmed. A previous study reported cases of prolonged time to therapy during defibrillation testing.

Objectives: We sought to evaluate the time to therapy, identify possible predictors of delay, and investigate the impact of delayed therapy on VF conversion.

Methods: We analyzed consecutive patients with S-ICDs who underwent initial conversion testing at a shock energy of 65 J in 53 Italian centers.

Results: We analyzed 570 patients (467 [82%] male; mean age 48 ± 15 years; mean body mass index 25 ± 6 kg/m; mean ejection fraction 47% ± 17%). General anesthesia was used in 165 (29%) of patients, with sub- or intermuscular positioning of the generator in (422; 74%). Cardioversion was successful at 65 J in 557 (97.7%) of patients. In 12 patients (2.1%) the shock did not convert VF, and in 1 patient the shock was not delivered because of noise from entrapped subcutaneous air. All failures were successfully managed by reprogramming or repositioning the device. The mean time to therapy was 15 ± 3 seconds, and it exceeded 18 seconds in 51 patients (9%). Independent predictors of delayed therapy (18 seconds) were ejection fraction (odds ratio [OR] 0.98; 95% confidence interval [CI] 0.96-0.99; P = .016) and a 2× gain programmed (OR 3.66; 95% CI 1.44-9.30; P = .006). Effectiveness at 65 J was not associated with time to therapy (OR 1.13; 95% CI 0.97-1.32; P = .122).

Conclusion: In this analysis of a large population of patients with S-ICDs, delayed therapy during defibrillation testing occurred less frequently than previously reported and had no effect on VF conversion success. Delayed therapies seemed more common when a vector with a 2× gain was programmed.
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http://dx.doi.org/10.1016/j.hrthm.2019.05.028DOI Listing
October 2019

Remote monitoring of subcutaneous implantable cardioverter defibrillators.

J Interv Card Electrophysiol 2018 Dec 1;53(3):373-381. Epub 2018 Oct 1.

Marche Polytechnic University, Ancona, Italy.

Background: Remote monitoring (RM) of implantable cardioverter defibrillators (ICD) has been shown to improve patient safety and reduce in-office visits. The subcutaneous ICD (S-ICD) is an effective alternative to transvenous ICD and has recently been endowed with the RM function. However, the RM communicator for S-ICD requires patient interaction to activate data transmission. We assessed patient compliance and acceptance.

Methods: Patients with S-ICD received the communicator and were followed up for 15 months. Weekly remote transmissions were programmed. Compliance with checks was measured as the number of checks performed by the patient divided by the number of automatic notifications by the communicator. A questionnaire on acceptance of the system was administered to patients.

Results: A total of 106 patients were analyzed. The proportion of weekly checks properly executed by the patients was 94% during the first 3 months and 93% from months 12 to 15. Of the checks performed, 93% were on the same day as the automatic notification. On a patient basis, compliance with weekly checks was > 85% (less than one check missed per month) in 88% of patients during the first 3 months and in 82% from months 12 to 15 (p = 0.615). No variables emerged as predictors of lower (≤ 85%) long-term compliance with weekly checks. During follow-up, 49 alerts were transmitted and the mean delay between the detected event and the patient transmission was 2 ± 2 days. The majority of patients found the system easy to use and felt confident about being remotely monitored.

Conclusions: The level of patient compliance with remote checks is high with current technology for RM of S-ICD. The vast majority of data transmissions are consistently performed on a weekly basis on the day scheduled.
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http://dx.doi.org/10.1007/s10840-018-0459-3DOI Listing
December 2018

Subcutaneous implantable cardioverter defibrillator in cardiomyopathies and channelopathies.

J Cardiovasc Med (Hagerstown) 2018 Nov;19(11):633-642

Department of Cardiac, Thoracic and Vascular Sciences, University of Padova.

: Cardiomyopathies and channelopathies are heterogeneous disorders that increase the risk of sudden cardiac death (SCD). Implantable cardioverter-defibrillator (ICD) therapy is safe and effective for preventing SCD in patients at risk for malignant ventricular arrhythmias. Because of the poor positive predictive value of current risk stratification tools, the majority of patients implanted with an ICD will never receive a life-saving therapy but will be exposed to the risk of complications such as device infection, lead failure and inappropriate therapy. Subcutaneous ICD (S-ICD) now constitutes a valuable alternative to conventional transvenous ICD in patients with cardiomyopathies and channelopathies as it provides protection from SCD while avoiding the risks of intravascular lead infection or failure. This may be particularly advantageous for young patients with a very long life expectancy. On the other hand, S-ICD cannot deliver antitachycardia pacing or antibradycardia pacing. The purpose of this article is to review the available evidence and the future perspectives of S-ICD therapy in patients with cardiomyopathies or channelopathies.
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http://dx.doi.org/10.2459/JCM.0000000000000712DOI Listing
November 2018

Subcutaneous implantable cardioverter defibrillator implantation: An analysis of Italian clinical practice and its evolution.

Int J Cardiol 2018 Dec 31;272:162-167. Epub 2018 Jul 31.

Second Cardiology Division, Cardio-Thoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy.

Background: The subcutaneous implantable cardioverter defibrillator (S-ICD) is a relatively novel alternative to the transvenous ICD for the treatment of life-threatening ventricular arrhythmias, and is currently used in the clinical practice of several centers. The aim of this analysis was to describe current Italian practice regarding S-ICD implantation and its evolution over the years.

Methods: We analyzed 607 consecutive patients (78% male, 48 ± 16 years) who underwent S-ICD implantation in 39 Italian centers from 2013 to 2017.

Results: Structural cardiomyopathy was present in 78% of patients and 30% of patients received their device for secondary prevention. The proportion of patients with dilated cardiomyopathy and with left ventricular ejection fraction ≤35% increased from ≤2014 to 2017 (from 38% to 58%, from 33% to 53%, respectively; both p < 0.05). Almost all procedures (97%) were performed in electrophysiology laboratories. Over the last 4 years, the 2-incision implantation technique has been widely adopted, with sub- or inter-muscular positioning of the generator, under local anesthesia or deep sedation (≤2014 versus 2017: all p < 0.001). Defibrillation testing was performed in 81% of patients. Shock energy of ≤65 J was successful in 93.9% of patients and the overall cardioversion success rate at ≤80 J was 99.8%.

Conclusions: Our analysis confirmed that the S-ICD continues to be preferentially used in specific patients (younger, less frequently with dilated cardiomyopathy and low ejection fraction.). Nonetheless, we noted a trend toward the wider use of S-ICD in patients with dilated cardiomyopathy and systolic dysfunction over the years. Novel approaches have been adopted while the acute efficacy of the system has remained stably high.
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http://dx.doi.org/10.1016/j.ijcard.2018.07.139DOI Listing
December 2018

Subcutaneous implantable cardioverter defibrillator eligibility according to a novel automated screening tool and agreement with the standard manual electrocardiographic morphology tool.

J Interv Card Electrophysiol 2018 Jun 3;52(1):61-67. Epub 2018 Mar 3.

University Hospital of Pisa, Pisa, Italy.

Purpose: Since subcutaneous implantable cardioverter defibrillator (S-ICD) introduction, the pre-implant screening based on a dedicated manual ECG tool (MST) was required to assure adequate sensing by the S-ICD. A novel automated screening tool (AST) has been recently developed. We assessed and compared the pass rate with AST and MST, and we measured the agreement between screening tools.

Methods: Three electrodes were positioned at locations mimicking the placement of the S-ICD, and ECG recordings were collected in the supine and standing postures at rest. The three sensing vectors were analyzed with the MST and the AST. Eligibility was defined by the presence of at least one or two appropriate vectors in both postures.

Results: A total of 235 patients with an indication to ICD and no need for permanent pacing were enrolled. At least one suitable vector was identified in 214 (91%) patients with MST and 221 (94%) patients with AST (p = 0.219). At least two vectors were appropriate in 162 (69%) patients with MST and 187 (80%) patients with AST (p = 0.008). Overall, out of 1587 ECG analyzed, 1035 (65%) qualifying leads were identified with MST and 1111 (70%) with AST (p = 0.004). The agreement between the results of MST and AST ECG analysis was moderate (Kappa = 0.570; standard error = 0.022; CI = 0.526-0.613). The results were consistent regardless of the underlying cardiomyopathy. The most frequent reason for screening failure with MST was a high-amplitude T-wave (31% of failures). With AST, 23% of recordings that failed with MST for high-amplitude T-wave were classified as acceptable.

Conclusion: The AST is associated with higher pass rate than the standard MST. It seems more tolerant of high-amplitude T-waves. Consequently, the agreement between MST and AST findings was only moderate.
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http://dx.doi.org/10.1007/s10840-018-0326-2DOI Listing
June 2018

Transvenous pacing in pediatric patients with bipolar lumenless lead: Ten-year clinical experience.

Int J Cardiol 2018 Mar 4;255:45-49. Epub 2018 Jan 4.

Cardiac Electrophysiology and Pacing Unit, Cardiovascular Department, Ospedale Papa Giovanni XXIII, Bergamo, Italy.

Introduction: A number of challenges can affect long-term performance of endocardial implanted systems in pediatric patients. Select Secure™ lead offers potential advantages for this population. This analysis aims to evaluate long-term performance of this lead in children, with and without congenital heart disease.

Methods: A retrospective analysis of all patients younger than 16years, implanted with at least one Select Secure™ lead at our institution, was performed. Clinical patient characteristics, electrical lead parameters, implant related complications, occurrence of surgical revisions and other complications were analyzed.

Results: From 2006 to 2016, 40 pediatric patients (26 males; age: 10.3±4.6years) underwent a cardiac device implantation with at least one Select Secure™ lead. Axillary vein access was chosen in 77.5% of the procedures. The intra-atrial loop of the leads was successfully created and the generator was placed in a sub-pectoral pocket in all patients. A total of 57 Select Secure™ leads were implanted: 23 in the right atrium and 34 in the right ventricle. PM/ICDs implantation was uneventful in all 40 patients. One lead, dislodged the day after implantation, was successfully extracted and replaced in the same day. Adequate pacing parameters were achieved during a follow-up of 6±2.9years (range 0.9-10.8years).

Conclusions: In a pediatric population, the Select Secure™ lead used in the axillary vein, the creation of an intra-atrial loop and the placement of the generator in a sub-pectoral pocket ensured a safe implantation of pacemaker or ICD and an effective stimulation at medium-term follow-up.
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http://dx.doi.org/10.1016/j.ijcard.2018.01.007DOI Listing
March 2018

Clinical outcomes of AF patients treated with the first and second-generation of circular mapping and ablation catheter: insights from a real world multicenter experience.

J Interv Card Electrophysiol 2017 Dec 5;50(3):245-251. Epub 2017 Sep 5.

Ospedale Papa Giovanni XXIII, Bergamo, Italy.

Purpose: Complete pulmonary vein isolation (PVI) is the best documented target for catheter ablation, and different technologies have shown comparable outcomes. The multielectrode phased-RF/duty cycled (PhRF/DC) pulmonary vein ablation catheter (PVAC) and its second generation (PVAC-GOLD) have shown promising clinical results in single and multicenter experiences. Our aim is to assess and compare the safety and efficacy in the real clinical practice among two generations of circular PhRF/DC catheters by performing PVI in patients suffering from recurrent atrial fibrillation (AF).

Methods: Eighty-four AF patients treated with PVAC and 64 with PVAC-GOLD were prospectively followed in five Italian cardiology centers in the mainframe of the 1STOP-ClinicalService project.

Results: Fluoroscopic and total procedure time were significantly different in the two groups. In particular, in the PVAC-GOLD group, the mean fluoroscopic time was 22.8 ± 12.7 min vs 31.6 ± 18.9 in the PVAC group (p = 0.002), and the mean total procedure duration was 117.6 ± 36.0 vs 147.4 ± 40.6, in the PVAC-GOLD group and the PVAC group, respectively (p = 0.001). Only two out of 148 patients reported a peri-procedural complication. Over 20.9 ± 12.0 months of follow-up, AF recurrence occurred in 58 patients. Kaplan-Meier freedom from AF recurrence did not differ between the two groups (64.1 ± 10% in the PVAC group vs 68.2 ± 9% in the PVAC-GOLD group at 1 year, p = ns).

Conclusions: In our multicenter analysis, AF ablation using two generations of circular PhRF/DC catheters is safe and effective. No difference was observed in terms of safety and efficacy of the AF ablation between the two catheters, with the mean procedural time being shorter in the PVAC-GOLD group.
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http://dx.doi.org/10.1007/s10840-017-0278-yDOI Listing
December 2017

External closed-circuit cooling system for management of patients after device implantation: A feasibility study.

Int J Cardiol 2017 Aug 19;241:235-237. Epub 2017 Apr 19.

Cardiac Electrophysiology and Pacing Unit, Cardiovascular Department, Ospedale Papa Giovanni XXIII, Bergamo, Italy. Electronic address:

Background: In the first 24h after pacemaker or implantable cardioverter/defibrillator (ICD) implantation or replacement, the occurrence of hematoma and pain in the surgically treated region is not infrequent and may result in re-intervention and/or more severe complications, such as infections. Currently, the post-implant phase management is very empiric. The aim of this study was to test the clinical applicability and usefulness of an external close-circuit cooling system for the management of the early post-implant period in patients with high risk of hematoma due to anticoagulant and/or antiplatelet therapy.

Methods: We studied 135 patients (78M; 71±11years) with high risk of hematoma occurrence after pace-maker (63 patients) or ICD (72 patients) implantation or replacement. Immediately after the intervention, a closed-circuit cooling system (CAREPACE™ system, Zamar, Italy) was externally applied on the pre-pectoral region to each patient and maintained for 24h. The system has a compressive pad and a refrigerating circuit in which non-toxic glycolic fluid is pumped. The fluid temperature was set and kept at 5°C for the whole period.

Results: The compressive and cooling effect of the system was well tolerated by all the patients at the temperature set. Four patients complained of noise due to machine operation, but in none the treatment was interrupted. The average length of hospital stay was 2.8±0.4days. No clinically significant hematoma was observed at discharge and after one month follow-up visit.

Conclusions: This new system can be used for the management of the early phase after device implantation or replacement and appears clinically useful and well tolerated. Further studies on a larger scale are needed to test the potential reduction of post-intervention complications and the cost-effectiveness of this device.
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http://dx.doi.org/10.1016/j.ijcard.2017.04.048DOI Listing
August 2017

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

Int J Cardiol 2017 Jun 19;236:181-186. Epub 2017 Jan 19.

Cardiology Dept., DIMES Department, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy and Cardiology Division, Department of Diagnostics, Clinical and Public Health Medicine. University of Modena and Reggio Emilia, Policlinico di Modena, Modena, Italy.

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.
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http://dx.doi.org/10.1016/j.ijcard.2017.01.101DOI Listing
June 2017

Effectiveness of subcutaneous implantable cardioverter-defibrillator testing in patients with hypertrophic cardiomyopathy.

Int J Cardiol 2017 Mar 4;231:115-119. Epub 2017 Jan 4.

Fondazione ARCARD, Florence, Italy.

Background: Subcutaneous ICD (S-ICD) is a promising option for Hypertrophic Cardiomyopathy (HCM) patients at risk of Sudden Cardiac Death (SCD). However, its effectiveness in terminating ventricular arrhythmias in HCM is yet unresolved.

Methods: Consecutive HCM patients referred for S-ICD implantation were prospectively enrolled. Patients underwent one or two attempts of VF induction by the programmer. Successful conversion was defined as any 65J shock that terminated VF (not requiring rescue shocks). Clinical and instrumental parameters were analyzed to study predictors of conversion failure.

Results: Fifty HCM patients (34 males, 40±16years) with a mean BMI of 25.2±4.4kg/m2 were evaluated. Mean ESC SCD risk of was 6.5±3.9% and maximal LV wall thickness (LVMWT) was 26±6mm. In 2/50 patients no arrhythmias were inducible, while in 7 (14%) only sustained ventricular tachycardia was induced and cardioverted. In the remaining 41 (82%) patients, 73 VF episodes were induced (1 episode in 14 and >1 in 27 patients). Of these, 4 (6%) spontaneously converted. In 68/69 (98%) the S-ICD successfully cardioverted, but failed in 1 (2%) patient, who needed rescue defibrillation. This patient was severely obese (BMI 36) and LVMWT of 25mm. VF was re-induced and successfully converted by the 80J reversed polarity S-ICD.

Conclusions: Acute DT at 65J at the implant showed the effectiveness of S-ICD in the recognition and termination of VT/VF in all HCM patients except one. Extreme LVH did not affect the performance of the device, whereas severe obesity was likely responsible for the single 65J failure.
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http://dx.doi.org/10.1016/j.ijcard.2016.12.187DOI Listing
March 2017

Intermuscular pocket for subcutaneous implantable cardioverter defibrillator: Single-center experience.

J Arrhythm 2016 Jun 23;32(3):223-6. Epub 2016 Feb 23.

Cardiac Electrophysiology and Pacing Unit, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo 24127, Italy.

The subcutaneous implantable cardioverter defibrillator (S-ICD) is a novel device now accepted in clinical practice for treating ventricular arrhythmias. In 14 consecutive patients, S-ICD devices were placed in the virtual space between the anterior surface of the serratus anterior muscle and the posterior surface of the latissimus dorsi muscle. During a mean follow up of 9 months, no dislocations, infections, hematoma formations, or skin erosions were observed. Intermuscular implantation of the S-ICD could be a reliable, safe, and appealing alternative to the standard subcutaneous placement.
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http://dx.doi.org/10.1016/j.joa.2016.01.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4913147PMC
June 2016

Device Longevity in a Contemporary Cohort of ICD/CRT-D Patients Undergoing Device Replacement.

J Cardiovasc Electrophysiol 2016 07 17;27(7):840-5. Epub 2016 Jun 17.

Institute of Cardiology, University of Bologna, Policlinico S.Orsola-Malpighi, Bologna, Italy.

Introduction: The longevity of defibrillators (ICD) is extremely important from both a clinical and economic perspective. We studied the reasons for device replacement, the longevity of removed ICD, and the existence of possible factors associated with shorter service life.

Methods And Results: Consecutive patients who underwent ICD replacement from March 2013 to May 2015 in 36 Italian centers were included in this analysis. Data on replaced devices were collected. A total of 953 patients were included in this analysis. In 813 (85%) patients the reason for replacement was battery depletion, while 88 (9%) devices were removed for clinical reasons and the remaining 52 because of system failure (i.e., lead or ICD generator failure or a safety advisory indication). The median service life was 5.9 years (25th-75th percentile, 4.9-6.9) for single- and dual-chamber ICD and 4.9 years (25th-75th percentile, 4.0-5.7) for CRT-D. On multivariate analysis, the factors CRT-D device, SC/DC ICD generator from Biotronik, percentage of ventricular pacing, and the occurrence of a system failure were positively associated with a replacement procedure. By contrast, the device from Boston Scientific was an independent protective factor against replacement. Considerable differences were seen in battery duration in both ICD and CRT-D. Specifically, Biotronik devices showed the shortest longevity among ICD and Boston Scientific showed the longest longevity among CRT-D (log-rank test, P < 0.001 for pairwise comparisons).

Conclusion: Several factors were associated with shorter service life of ICD devices: CRT-D, occurrence of system failure and percentage of ventricular pacing. Our results confirmed significant differences among manufacturers.
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http://dx.doi.org/10.1111/jce.12990DOI Listing
July 2016

Detect Long-term Complications After ICD Replacement (DECODE): Rationale and Study Design of a Multicenter Italian Registry.

Clin Cardiol 2015 Oct 18;38(10):577-84. Epub 2015 Aug 18.

Institute of Cardiology, University of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy.

The replacement of implantable cardioverter-defibrillators (ICDs) may give rise to considerable clinical consequences, the importance of which is underrated by the medical community. Replacement-related adverse events are difficult to identify and require monitoring of both short-term complications and long-term patient outcome. The aim of this study is to perform a structured evaluation of both short- and long-term adverse events and a cost analysis of consecutive ICD replacement procedures. Detect Long-term Complications After ICD Replacement (DECODE) is a prospective, single-arm, multicenter cohort study designed to estimate long-term complication rates (at 12 months and 5 years) in patients undergoing ICD generator replacement. The study will also evaluate predictors of complications, patient management before and during the replacement procedure in clinical practice, and the costs related to use of health care resources. About 800 consecutive patients with standard indications for ICD generator replacement will be enrolled in this study. The decision to undertake generator replacement/upgrade will be made according to the investigators' own judgment (which will be recorded). Patients will be followed for 60 months through periodic in-hospital examinations or remote monitoring. Detailed data on complications related to ICD replacement in current clinical practice are still lacking. The analysis of adverse events will reveal the value of new preventive strategies, thereby yielding both clinical and economic benefits. Moreover, assessment of complication rates after ICD replacement in a real-life setting will help estimate the actual long-term cost of ICD therapy and assess the real impact of increasing ICD longevity on cost-effectiveness.
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http://dx.doi.org/10.1002/clc.22440DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6490824PMC
October 2015

Cavotricuspid isthmus ablation and subcutaneous monitoring device implantation in a 2-year-old baby with 2 SCN5A mutations, sinus node dysfunction, atrial flutter recurrences, and drug induced long-QT syndrome: a tricky case of pediatric overlap syndrome?

J Cardiovasc Electrophysiol 2015 Mar 30;26(3):346-9. Epub 2014 Nov 30.

Cardiac Electrophysiology and Pacing Unit, Cardiovascular Department, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.

We describe the case of 2-year-old baby with compound heterozygosity for paternal and maternal alleles mutation of α-subunit of the cardiac sodium channel (SCN5A), sinus node dysfunction, atrial flutter recurrences, and drug induced long-QT syndrome. In this setting, we chose at first to perform linear ablation of cavotricuspid isthmus resulting in a bidirectional isthmus block. As a second step, we decided to implant a miniaturized loop recorder that, with a minimally invasive procedure, permits us to follow the development of the disease in order to define the future strategy. After 8 months follow-up, automatic daily loop-recorder transmissions disclose the complete absence of any arrhythmia along with asymptomatic ventricular pauses due to sinus node dysfunction. Echocardiography shows normal findings, in particular no left ventricular dysfunction.
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http://dx.doi.org/10.1111/jce.12570DOI Listing
March 2015

A contemporary European experience with surgical septal myectomy in hypertrophic cardiomyopathy.

Eur Heart J 2012 Aug 20;33(16):2080-7. Epub 2012 Apr 20.

Dipartimento Cardiovascolare, Ospedali Riuniti, Bergamo 24128, Italy.

Aims: The recent American College of Cardiology and American Heart Association Guidelines on hypertrophic cardiomyopathy (HCM) have confirmed surgical myectomy as the gold standard for non-pharmacological treatment of obstructive HCM. However, during the last 15 years, an extensive use of alcohol septal ablation has led to the virtual extinction of myectomy programmes in several European countries. Therefore, many HCM candidates for myectomy in Europe cannot be offered the option of this procedure. The purpose of our study is to report the difficulties and results in developing a myectomy programme for HCM in a centre without previous experience with this procedure.

Methods And Results: The clinical course is reported of 124 consecutive patients with obstructive HCM and heart failure symptoms who underwent myectomy at a single European centre between 1996 and 2010. The median follow-up was 20.3 months (inter-quartile range: 3.9-40.6 months). No patients were lost to follow-up. A cumulative incidence of HCM-related death after myectomy was 0.8, 3.3, and 11.2% at 1, 5, and 10 years, respectively, including one operative death (procedural mortality 0.8%). The left ventricular (LV) outflow gradient decreased from 95 ± 36 mmHg before surgery to 12 ± 6 mmHg at most recent evaluation (P < 0.001), with none of the patients having a significant residual LV outflow gradient. Of the 97 patients in New York Heart Association functional class III-IV before surgery, 93 (96%) were in class I-II at most recent evaluation (P < 0.001).

Conclusion: Our results show that the development of a myectomy programme at a centre without previous experience with this procedure is feasible and can lead to highly favourable clinical results.
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http://dx.doi.org/10.1093/eurheartj/ehs064DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3418509PMC
August 2012

Curative ablation in a 12-month-old baby with severe ventricular systolic dysfunction and incessant ventricular tachycardia.

Europace 2011 Jul 18;13(7):1052-5. Epub 2011 Mar 18.

Cardiovascular Department, Clinical Electrophysiology, Ospedali Riuniti Bergamo, Largo Barozzi 1, Bergamo, Italy.

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http://dx.doi.org/10.1093/europace/eur054DOI Listing
July 2011

Treatment of atrial fibrillation with a dual defibrillator in heart failure patients (TRADE HF): protocol for a randomized clinical trial.

Trials 2011 Feb 15;12:44. Epub 2011 Feb 15.

U.O. di Cardiologia, Ospedale S, Anna, Como, Italy.

Background: Heart failure(HF) and atrial fibrillation(AF) frequently coexist in the same patient and are associated with increased mortality and frequent hospitalizations. As the concomitance of AF and HF is often associated with a poor prognosis, the prompt treatment of AF in HF patients may significantly improve outcome.

Methods/design: Recent implantable cardiac resynchronization (CRT) devices allow electrical therapies to treat AF automatically. TRADE-HF (trial registration: NCT00345592; http://www.clinicaltrials.gov) is a prospective, randomized, double arm study aimed at demonstrating the efficacy of an automatic, device-based therapy for treatment of atrial tachycardia and fibrillation(AT/AF) in patients indicated for CRT. The study compares automatic electrical therapy to a traditional more usual treatment of AT/AF: the goal is to demonstrate a reduction in a combined endpoint of unplanned hospitalizations for cardiac reasons, death from cardiovascular causes or permanent AF when using automatic atrial therapy as compared to the traditional approach involving hospitalization for symptoms and in-hospital treatment of AT/AF.

Discussion: CRT pacemaker with the additional ability to convert AF as well as ventricular arrhythmias may play a simultaneous role in rhythm control and HF treatment. The value of the systematic implantation of CRT ICDs with the capacity to deliver atrial therapy in HF patients at risk of AF has not yet been explored. The TRADE-HF study will assess in CRT patients whether a strategy based on automatic management of atrial arrhythmias might be a valuable option to reduce the number of hospital admission and to reduce the progression the arrhythmia to a permanent form.

Trial Registration: NCT00345592.
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http://dx.doi.org/10.1186/1745-6215-12-44DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3049181PMC
February 2011

Malignant perinatal variant of long-QT syndrome caused by a profoundly dysfunctional cardiac sodium channel.

Circ Arrhythm Electrophysiol 2008 Dec 2;1(5):370-8. Epub 2008 Dec 2.

Department of Medicine, Vanderbilt University, Nashville, TN 37232-0275, USA.

Background: Inherited cardiac arrhythmia susceptibility contributes to sudden death during infancy and may contribute to perinatal and neonatal mortality, but the molecular basis of this risk and the relationship to genetic disorders presenting later in life is unclear. We studied the functional and pharmacological properties of a novel de novo cardiac sodium channel gene (SCN5A) mutation associated with an extremely severe perinatal presentation of long-QT syndrome in unrelated probands of different ethnicity.

Methods And Results: Two subjects exhibiting severe fetal and perinatal ventricular arrhythmias were screened for SCN5A mutations, and the functional properties of a novel missense mutation (G1631D) were determined by whole-cell patch clamp recording. In vitro electrophysiological studies revealed a profound defect in sodium channel function characterized by approximately 10-fold slowing of inactivation, increased persistent current, slowing of recovery from inactivation, and depolarized voltage dependence of activation and inactivation. Single-channel recordings demonstrated increased frequency of late openings, prolonged mean open time, and increased latency to first opening for the mutant. Subjects carrying this mutation responded clinically to the combination of mexiletine with propranolol and survived. Pharmacologically, the mutant exhibited 2-fold greater tonic and use-dependent mexiletine block than wild-type channels. The mutant also exhibited enhanced tonic (2.4-fold) and use-dependent block ( approximately 5-fold) by propranolol, and we observed additive effects of the 2 drugs on the mutant.

Conclusions: Our study demonstrates the molecular basis for a malignant perinatal presentation of long-QT syndrome, illustrates novel functional and pharmacological properties of SCN5A-G1631D, which caused the disorder, and reveals therapeutic benefits of propranolol block of mutant sodium channels in this setting.
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http://dx.doi.org/10.1161/CIRCEP.108.788349DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2725366PMC
December 2008

Ablate and pace as bail-out therapy in a patient with Fontan correction and malignant atrial tachycardia.

Europace 2009 Sep 22;11(9):1245-7. Epub 2009 Jul 22.

Cardiovascular Department Cardiac Electrophysiology, Ospedali Riuniti di Bergamo, Largo Barozzi 1, 24128 Bergamo, Italy.

Atrial tachyarhthmias complicating Fontan correction may have a 'malignant' clinical presentation seriously impairing the patient haemodynamic. Current strategies are surgical total cavopulmonary connection with or without antiarrhythmic surgery or transcatheter ablation. We describe the case of a patient who previously underwent atriocaval Fontan correction and later presented with refractory atrial tachycardia responsible for relapsing syncope. After a failed attempt at surgical conversion, and while waiting for heart transplantation, he was submitted to ablation of the atrioventricular node through an aortic retrograde approach and ventricular pacing through the coronary sinus tree. One year later, the patient is doing well, displaying a stable functional recovery and excellent pacing lead performances. An ablate and pace approach may deserve consideration in selected Fontan patients experiencing life-threatening atrial arrhythmias.
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http://dx.doi.org/10.1093/europace/eup186DOI Listing
September 2009