Publications by authors named "Federico Migliore"

112 Publications

Totally Peripheral Approach for ICD Lead Vegetation Removal in a GUCH patient.

J Cardiovasc Electrophysiol 2021 Apr 6. Epub 2021 Apr 6.

Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.

AngioVac system (AngioDynamics, Latham, NY) has already proved to be a useful tool in the treatment of thrombotic and endocarditic formations concerning the venous district. Herein, the AngioVac aspiration system combined with the bidirectional rotational Evolution mechanical sheath lead extraction was used for an effective and safety cardiac-device-related-infective-endocarditis removal in a GUCH patient through a totally peripheral approach. This article is protected by copyright. All rights reserved.
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http://dx.doi.org/10.1111/jce.15032DOI Listing
April 2021

Extraction of a very old His bundle pacing lead: A safe and effective procedure?

Pacing Clin Electrophysiol 2021 Mar 24. Epub 2021 Mar 24.

Cardiology Department, Arrhythmia and Electrophysiology Unit, Santa Maria Della Misericordia Hospital, Rovigo, Italy.

Permanent His bundle pacing (HBP) has rapidly been adapted into clinical practice in recent years as a physiologic pacing. The 3830 (Medtronic Inc, MN, USA) pacing lead commonly used for HBP is lumenless, and there are limited reports available on extraction of this lead. No data exists on transvenous lead extraction (TLE) of very old HBP lead. Concerns remain about injury to the conduction system during extraction and the lack of lumen for placing a locking stylet for TLE when powered sheaths are required. We reported a unique case of TLE of very old HBP lead (14 years and 3 months) and other two leads, such as passive atrial and passive right ventricular apex backup.
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http://dx.doi.org/10.1111/pace.14227DOI Listing
March 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

"Apical sparing" T-wave inversion in a case of mid-ventricular takotsubo syndrome.

Pacing Clin Electrophysiol 2021 Mar 18;44(3):559-563. Epub 2021 Jan 18.

Department of Cardiac, Thoracic and Vascular Sciences and Public Health, University of Padova, Padova, Italy.

Previous studies showed that myocardial edema correlates with dynamic T-wave inversion and QTc prolongation in a variety of acute cardiovascular diseases including takotsubo syndrome (TTS). We reported the case of a patient with "atypical" (mid-ventricular) TTS showing a unique pattern of diffuse T-wave inversion that spared only the apical precordial leads V3-V4. Cardiac magnetic resonance (CMR) showed myocardial edema involving all mid-ventricular segments but not the apex. Both ECG and CMR normalized at follow-up evaluation. This case further reinforces the theory of an association between presence and regional distribution of acute myocardial inflammation and dynamic repolarization changes.
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http://dx.doi.org/10.1111/pace.14165DOI Listing
March 2021

Successful jugular implantable defibrillator lead extraction with bidirectional rotational mechanical sheath.

Pacing Clin Electrophysiol 2021 Mar 12;44(3):557-558. Epub 2021 Jan 12.

Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.

Bidirectional rotational mechanical sheath is an effective and safe technique for transvenous lead extraction of chronically implanted leads. However, data about powered mechanical sheath through jugular vein are lacking. Our report demonstrated that bidirectional rotational mechanical sheath represents an effective and safe approach for removal of chronically implanted jugular leads.
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http://dx.doi.org/10.1111/pace.14160DOI Listing
March 2021

Subcutaneous implantable cardioverter-defibrillator and left ventricular assist devices for refractory heart failure: attention to possible interference.

J Cardiovasc Med (Hagerstown) 2021 Jan 4;Publish Ahead of Print. Epub 2021 Jan 4.

Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.

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http://dx.doi.org/10.2459/JCM.0000000000001148DOI Listing
January 2021

Characteristics and hospital course of patients admitted for acute cardiovascular diseases during the coronavirus disease-19 outbreak.

J Cardiovasc Med (Hagerstown) 2021 01;22(1):29-35

Department of Cardiac, Thoracic and Vascular Sciences and Public Health, University of Padova, Padua, Italy.

Introduction: During the coronavirus disease-19 (COVID-19) outbreak in spring 2020, people may have been reluctant to seek medical care fearing infection. We aimed to assess the number, characteristics and in-hospital course of patients admitted for acute cardiovascular diseases during the COVID-19 outbreak.

Methods: We enrolled all consecutive patients admitted urgently for acute myocardial infarction, heart failure or arrhythmias from 1 March to 31 May 2020 (outbreak period) and 2019 (control period). We evaluated the time from symptoms onset to presentation, clinical conditions at admission, length of hospitalization, in-hospital medical procedures and outcome. The combined primary end point included in-hospital death for cardiovascular causes, urgent heart transplant or discharge with a ventricular assist device.

Results: A similar number of admissions were observed in 2020 (N = 210) compared with 2019 (N = 207). Baseline characteristics of patients were also similar. In 2020, a significantly higher number of patients presented more than 6 h after symptoms onset (57 versus 38%, P < 0.001) and with signs of heart failure (33 versus 20%, P = 0.018), required urgent surgery (13 versus 5%, P = 0.004) and ventilatory support (26 versus 13%, P < 0.001). Hospitalization duration was longer in 2020 (median 10 versus 8 days, P = 0.03). The primary end point was met by 19 (9.0%) patients in 2020 versus 10 (4.8%) in 2019 (P = 0.09).

Conclusion: Despite the similar number and types of unplanned admissions for acute cardiac conditions during the 2020 COVID-19 outbreak compared with the same period in 2019, we observed a higher number of patients presenting late after symptoms onset as well as longer and more complicated clinical courses.
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http://dx.doi.org/10.2459/JCM.0000000000001129DOI Listing
January 2021

Arrhythmogenic Cardiomyopathy.

Eur Heart J 2020 12;41(47):4457-4462

Department of Cardiac, Thoracic and Vascular Sciences and Public Health, University of Padua Medical School, Padua, Italy.

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http://dx.doi.org/10.1093/eurheartj/ehaa719DOI Listing
December 2020

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

Conduction disorders after aortic valve replacement with rapid-deployment bioprostheses: early occurrence and one-year evolution.

Ann Cardiothorac Surg 2020 Sep;9(5):396-407

Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.

Background: Rapid-deployment bioprostheses represent one of the newest aortic valve substitutes introduced into clinical practice. The aim of this retrospective single-center study was to evaluate the occurrence of conduction disorders (CDs) after rapid-deployment aortic valve implantation at discharge and at 1-year follow-up, and to identify risk factors for CDs and permanent pacemaker implantation (PPI).

Methods: All patients who reached 1-year follow-up after isolated or combined aortic valve replacement (AVR) with rapid-deployment bioprostheses (Intuity Elite, Edwards Lifesciences, Irvine, CA) at our institution were included in this study. Standard 12-lead electrocardiograms (ECGs) were recorded before the procedure (within 24 hours), after the procedure as soon as the patient was moved to the intensive care unit (ICU), every day during in-hospital stay and at 1-year follow-up. The primary endpoint was the incidence of postoperative CDs at discharge and at 1-year follow up. Patients were divided in two groups: those who developed the primary endpoint (Group CD) and those who didn't (Group Non-CD).

Results: A total of 98 consecutive patients were included in the study. At discharge, the primary endpoint occurred in 40 patients (40.8%). In particular, new CDs and PPI occurred in 33 (33.7%) and in 7 (7.1%) patients, respectively. Valve size was the only independent predictor of primary endpoint at discharge. At 1-year, 30 patients (31.3%) presented with CDs or pacemaker-induced rhythm. In particular, in 25 patients of Group CD (64.1%), 1-year follow-up ECG revealed the persistence of the same CD as at discharge or pacemaker-induced rhythm, while 14 patients (35.9%) showed recovery of their CD. Age and prosthesis size were identified as independent predictors of CDs/pacemaker-induced rhythm at 1-year follow-up.

Conclusions: According to our data, nearly 40% of patients develop a new CD after rapid-deployment aortic valve implantation. Of these, one third recover after one year. Bioprosthesis size and age were identified as independent risk factors for occurrence of CD after surgery.
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http://dx.doi.org/10.21037/acs-2020-surd-14DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7548210PMC
September 2020

Screening of unknown atrial fibrillation through handheld device in the elderly.

J Geriatr Cardiol 2020 Aug;17(8):495-501

Department of Cardio-Thoraco-Vascular Sciences and Public Health, University of Padova, Padova, Italy.

Objective: To estimate the prevalence of unknown atrial fibrillation (AF) in the elderly population of the Veneto Region, Italy.

Methods: 1820 patients aged ≥ 65 years with no history of AF and not anticoagulated were enrolled in primary-care settings. They underwent an opportunistic electrocardiogram screening with a handheld device (MyDiagnostick) designed to specifically detect AF. The electrocardiogram recordings were reviewed by the researchers, who confirmed the presence of AF.

Results: The device detected an arrhythmia in 143 patients, which was confirmed as AF in 101/143 (70.6%), with an overall prevalence of AF of 5.5% (101/1820). Prevalence of unknown AF resulted in 3.6% in patients aged 65-74 years, and 7.5% in patients age 75 or older, and increased according to CHADS-VASc score: 3.5% in patients with a score of 1 or 2, 5.6% in patients with a score of 3, 7.0% in patients with a score of 4, and 7.2% in patients with a score ≥ 5. The detection rate was significantly higher in patients with mild symptoms compared to asymptomatic counterparts (24.1% 4.0%, < 0.0001). At multivariate analysis, congestive heart failure and age ≥ 75 years-old were independent predictors for screen-detected AF.

Conclusions: An opportunistic screening with handheld device revealed an unexpectedly high prevalence of unknown AF in elderly patients with mild symptoms. Prevalence increased with age and CHADS-VASc score.
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http://dx.doi.org/10.11909/j.issn.1671-5411.2020.08.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7475215PMC
August 2020

Diagnosis of arrhythmogenic cardiomyopathy: The Padua criteria.

Int J Cardiol 2020 11 16;319:106-114. Epub 2020 Jun 16.

Department of Cardiac, Thoracic and Vascular Sciences and Public Health, University of Padova, Italy.

The original designation of "Arrhythmogenic right ventricular (dysplasia/) cardiomyopathy"(ARVC) was used by the scientists who first discovered the disease, in the pre-genetic and pre-cardiac magnetic resonance era, to describe a new heart muscle disease predominantly affecting the right ventricle, whose cardinal clinical manifestation was the occurrence of malignant ventricular arrhythmias. Subsequently, autopsy investigations, genotype-phenotype correlations studies and the increasing use of contrast-enhancement cardiac magnetic resonance showed that the fibro-fatty replacement of the myocardium represents the distinctive phenotypic feature of the disease that affects the myocardium of both ventricles, with left ventricular involvement which may parallel or exceed the severity of right ventricular involvement. This has led to the new designation of "Arrhythmogenic Cardiomyopathy" (ACM), that represents the evolution of the original term of ARVC. The present International Expert Consensus document proposes an upgrade of the criteria for diagnosis of the entire spectrum of the phenotypic variants of ACM. The proposed "Padua criteria" derive from the diagnostic approach to ACM, which has been developed over 30 years by the multidisciplinary team of basic researchers and clinical cardiologists of the Medical School of the University of Padua. The Padua criteria are a working framework to improve the diagnosis of ACM by introducing new diagnostic criteria regarding tissue characterization findings by contrast-enhanced cardiac magnetic resonance, depolarization/repolarization ECG abnormalities and ventricular arrhythmia features for diagnosis of the left ventricular phenotype. The proposed diagnostic criteria need to be further validated by future clinical studies in large cohorts of patients.
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http://dx.doi.org/10.1016/j.ijcard.2020.06.005DOI Listing
November 2020

Evaluation of mexiletine effect on conduction delay and bradyarrhythmic complications in patients with myotonic dystrophy type 1 over long-term follow-up.

Heart Rhythm 2020 11 7;17(11):1944-1950. Epub 2020 Jun 7.

Department of Cardiac, Thoracic and Vascular Sciences and Public Health, University of Padova, Padova, Italy.

Background: Myotonic dystrophy type 1 (DM1) is a multisystemic disorder characterized by progressive cardiac conduction impairment, arrhythmias, and sudden death. Mexiletine is a sodium channel blocker drug used by patients with DM1 for treatment of myotonia, even though definitive proof of its safety over long-term follow-up is lacking.

Objective: The purpose of this study was to assess the impact of mexiletine for treatment of neurological symptoms on the composite endpoint of significant electrocardiogram modification (new onset or worsening of atrioventricular [AV] or intraventricular conduction delay) and bradyarrhythmic complications requiring pacemaker (PM) implantation (advanced AV block, symptomatic sinus pause >3 seconds).

Methods: This retrospective longitudinal study included a series of consecutive patients with genetically confirmed DM1 evaluated at our neurology and cardiology clinics from January 1, 2011, to January 1, 2020, who received mexiletine 200 mg twice daily. Patients with a PM, implantable cardioverter-defibrillator, or severe conduction abnormality (PQ interval ≥230 ms, complete bundle branch block, or atrial fibrillation) at enrollment were excluded.

Results: The study comprised 18 mexiletine-treated patients and 68 mexiletine-free controls. Over median follow-up of 53 months, the endpoint was reached by 4 (22%) mexiletine-treated patients and 23 (33%) non-mexiletine-treated patients (log-rank P = .45). In 3 non-mexiletine-treated patients, bradyarrhythmic complications requiring PM implantation were observed. At univariable analysis, only the presence of mild conduction delay (first-degree AV block with PQ interval <230 ms or left anterior fascicular block) at baseline predicted the endpoint (hazard ratio 2.22; 95% confidence interval 1.04-4.76).

Conclusion: Mexiletine 200 mg twice daily is safe in patients with DM1 and no severe conduction abnormality.
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http://dx.doi.org/10.1016/j.hrthm.2020.05.043DOI Listing
November 2020

Axillary vein access for permanent pacemaker and implantable cardioverter defibrillator implantation: Fluoroscopy compared to ultrasound.

Pacing Clin Electrophysiol 2020 06 29;43(6):566-572. Epub 2020 May 29.

Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.

Background: Axillary vein access (AVA) using fluoroscopic landmarks is an effective and safe approach for cardiac implantable electronic devices (CIEDs) implantation. However, it may result in a higher radiation exposure. Ultrasound-guided axillary access (USAA) is an effective alternative technique to conventional subclavian access for CIEDs implantation. Studies comparing USAA and AVA using fluoroscopic landmarks are lacking. The purpose of this study was to compare the safety, efficacy, and radiation exposure data of the USAA approach with the AVA using fluoroscopic landmarks.

Methods: The study population included 95 consecutive patients (61% male, median age 78 years [71-85 years]) referred for CIEDs implantation using AVA with fluoroscopic landmark (n = 46) or USAA (n = 49). Baseline characteristics and radiation exposure data (Air-Kerma [mGy], DAP [Gy-cm ], fluoroscopy time [seconds], and X-rays emission time [seconds]) were compared according to the technique used for the AVA.

Results: Axillary vein was successfully accessed in 45 of 49 (92%) patients using ultrasound and in 42 of 46 (91%) patients using fluoroscopic landmarks (P = 1.00). Air-Kerma, DAP, fluoroscopy time, and X-rays emission time were shorter for USAA group compared with AVA using fluoroscopic landmarks (11 mGy [8-20] vs 37 mGy [24-81], P < .00001; 3 Gy-cm [2-5] vs 10 Gy-cm [6-16], P < .00001; 97 seconds [62-163] vs 271 seconds [185-365], P < .00001; and 7 seconds [4-10] vs 21 seconds [13-39], P < .00001). There were no significant differences between the two groups in median implant procedure time (P = .55). We did not encounter any acute or long-term complications in both groups.

Conclusions: Ultrasound-guided axillary vein cannulation for CIEDs implantation is a feasible and safe alternative approach and offers a significant reduction in fluoroscopy times without increasing procedural time.
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http://dx.doi.org/10.1111/pace.13940DOI Listing
June 2020

Ultrasound-guided serratus anterior plane block for subcutaneous implantable cardioverter defibrillator implantation using the intermuscular two-incision technique.

J Interv Card Electrophysiol 2020 Mar 3;57(2):303-309. Epub 2020 Jan 3.

Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Via N. Giustiniani 2, 35121, Padova, Italy.

Purpose: Operative anaesthetic requirements and perioperative discomfort are barriers to wide adoption of the subcutaneous implantable cardioverter defibrillator (S-ICD) system, especially when the intermuscular technique is used because of the greater amount of tissue dissection. The procedure is most commonly performed under general anaesthesia (GA). There is growing interest in transitioning away from the routine use of GA and towards several alternative anaesthesia modalities for the S-ICD implant procedure without the involvement of an anaesthesiologist. We assessed the feasibility of ultrasound-guided serratus anterior plane block (US-SAPB) in patients undergoing S-ICD implantation with the intermuscular two-incision technique.

Methods: The study population included 38 consecutive patients (84% male; median, 53 [46-62] years) who received S-ICD implantation using the intermuscular two-incision technique. All procedures were performed under US-SAPB and conscious sedation without the involvement of an anaesthesiologist.

Results: The average procedure time was 67 ± 14 min. No patient experienced significant haemodynamic changes or oxygen desaturation during the period of the US-SAPB procedure and sedation; there was no need for pharmacological interventions. The entire procedure was well tolerated without discomfort or complications and with no need for GA, except in one (2.6%) patient who received GA with a laryngeal mask airway. Patients always remained able to respond appropriately to neurological monitoring during the S-ICD implantation procedure. There were no procedure-related complications.

Conclusions: US-SAPB and the intermuscular two-incision technique may be a promising safe and feasible combination for S-ICD implantation, overcoming the potential barrier to wider S-ICD adoption in clinical practice.
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http://dx.doi.org/10.1007/s10840-019-00669-xDOI Listing
March 2020

Clinical predictors of pocket hematoma after cardiac device implantation and replacement.

J Cardiovasc Med (Hagerstown) 2020 Feb;21(2):123-127

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

Aims: Pocket hematoma is a common complication of cardiac implantable electronic device (CIED) procedures. the aim of the study was to research the clinical factors associated with pocket hematoma formation after CIED implantation or replacement and to identify the best perioperative antithrombotic management.

Methods: We retrospectively analyzed 500 consecutive patients who underwent to CIED implantation or replacement at our center from November 2014.

Results: Among our population, 206 patients (41.2%) were on anticoagulant therapy at the time of the intervention: 68 (13.6%) on ongoing Warfarin; 111 (22.2%) on low-molecular-weight heparin (LMWH); and 27 (5.4%) on ongoing direct oral anticoagulants. Antiplatelet therapy was present in 262 (52.4%) patients: in particular, 50 (10%) were on dual antiplatelet therapy, 64 (12.8%) were on single antiplatelet therapy and anticoagulant therapy, whereas 12 (2.4%) were on anticoagulant with dual antiplatelet therapy.Incidence of pocket hematoma after CIEDs implantation was of 4.6%. Considering the different perioperative anticoagulant strategies, patients on LMWH presented the higher hematoma rate [11/100 patients (11.0%), P < 0.001]. At the multivariate analysis, anticoagulant with dual antiplatelet therapy (P = 0.021, OR 6.3, IC 1.3-30.8), left ventricular ejection fraction (LVEF) less than 30% (P < 0.001, OR 7.4, IC 2.7-20.4), and use of LMWH (P = 0.008, OR 3.8, IC 1.4-10.6) resulted the strongest predictors of pocket hematoma (Hosmer test = 0.899).Considering replacement procedures, incidence of pocket hematoma was of 4.4%. The incidence was higher after ICD/CRT-D replacement. The majority of pocket hematoma occurred in patients with mechanical valve prosthesis (3/4 cases, 75%, P < 0.001).

Conclusion: The use of LMWH and a low LVEF expose patients to a higher risk of pocket hematoma after CIED procedures. Anticoagulant with dual antiplatelet therapy and LMWH should be avoided.
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http://dx.doi.org/10.2459/JCM.0000000000000914DOI Listing
February 2020

[The subcutaneous implantable cardioverter-defibrillator in clinical practice].

G Ital Cardiol (Rome) 2019 Nov;20(11):641-650

Dipartimento Cardio-Toraco-Vascolare, Università degli Studi, Padova.

Overcoming lead-related complications, the subcutaneous implantable cardioverter-defibrillator (S-ICD) represents the greatest advancement in the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Due to the absence of leads within the body, the S-ICD requires an innovative approach for sensing of subcutaneous signals and defibrillation. The aim of this review is to analyze the current evidence regarding patient selection, technical aspects such as the implant technique, programming and follow-up, as well as complications and troubleshooting of this innovative technology.
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http://dx.doi.org/10.1714/3254.32225DOI Listing
November 2019

Twiddler's Syndrome Combined With Subclavian Crush Syndrome: A Case of ICD Lead Failure and Potential Challenging Lead Extraction.

J Invasive Cardiol 2019 Nov;31(11):E340

Department of Cardiac Thoracic and Vascular Sciences, University of Padova, Via N. Giustiniani 2 35121 Padova, Italy.

Our report demonstrates how Twiddler's syndrome associated with subclavian crush syndrome may result in a challenging transvenous lead extraction. Thus, it should be performed in centers with experience with the appropriate tools.
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November 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

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

Pacing Clin Electrophysiol 2019 07 2;42(7):989-997. Epub 2019 May 2.

Department of Cardiology and Cardiothoracic Surgery, Arrhythmia Unit and Electrophysiology Laboratories, Ospedale San Raffaele, Milan, Italy.

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.
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http://dx.doi.org/10.1111/pace.13700DOI Listing
July 2019

Multicentre experience with the second-generation subcutaneous implantable cardioverter defibrillator and the intermuscular two-incision implantation technique.

J Cardiovasc Electrophysiol 2019 06 13;30(6):854-864. Epub 2019 Mar 13.

Cardiovascular Department, University of Trieste, Trieste, Italy.

Introduction: The recently developed second-generation subcutaneous implantable cardioverter defibrillator (S-ICD) and the intermuscular two-incision implantation technique demonstrate potential favorable features that reduce inappropriate shocks and complications. However, data concerning large patient populations are lacking. The aim of this multicentre prospective study was to evaluate the safety and outcome of second-generation S-ICD using the intermuscular two-incision technique in a large population study.

Methods And Results: The study population included 101 consecutive patients (75% male; mean age, 45 ± 13 years) who received second-generation S-ICD (EMBLEM; Boston Scientific, Marlborough, MA) implantation using the intermuscular two-incision technique as an alternative to the standard implantation technique. Twenty nine (29%) patients were implanted for secondary prevention. Twenty four (24%) patients had a previously implanted transvenous ICD. All patients were implanted without any procedure-related complications. Defibrillation testing was performed in 80 (79%) patients, and ventricular tachycardia was successfully converted at less than or equal to 65 J in 98.75% (79/80) of patients without pulse generator adjustments. During a median follow-up of 21 ± 10 months, no complications requiring surgical revision or local or systemic device-related infections were observed. Ten patients (9.9%) received appropriate and successful shocks for ventricular arrhythmias. Three (2.9%) patients experienced inappropriate shocks due to oversensing the cardiac signal (n = 1), noncardiac signal (n = 1), and a combination of both cardiac and noncardiac signals (n = 1), with one patient requiring device explantation. No patients required device explantation due to antitachycardia pacing indications.

Conclusions: According to our multicentre study, second-generation S-ICD implanted with the intermuscular two-incision technique is an available safe combination and appears to be associated with a low risk of complications, such as inappropriate shocks.
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http://dx.doi.org/10.1111/jce.13894DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6850019PMC
June 2019

Subcutaneous implantable cardioverter defibrillator in patients with arrhythmogenic right ventricular cardiomyopathy: Results from an Italian multicenter registry.

Int J Cardiol 2019 04 12;280:74-79. Epub 2019 Jan 12.

Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Italy. Electronic address:

Background: Despite expanding indication of the subcutaneous implantable cardioverter defibrillator (S-ICD) in clinical practice, limited data exists on safety and efficacy of S-ICD in arrhythmogenic right ventricular cardiomyopathy (ARVC) patients. The aim of this multicenter study was to evaluate the safety and efficacy of S-ICD in ARVC patients.

Methods: The study population included 44 consecutive patients with definite ARVC diagnosis according to the 2010 ITF criteria (57% male, mean age 37 ± 17 years [range 10-75 years]) who received an S-ICD. Eighteen (41%) patients were implanted for secondary prevention.

Results: At implant, all inducible patients (34/44) had conversion of ventricular fibrillation at 65 J. No early complications occurred. During a median follow-up of 12 months (7-19), 3 (6.8%) patients experienced complications requiring surgical revision. No local or systemic device-related infections were observed. Six patients (14%) received a total of 61 appropriate and successful shocks on ventricular arrhythmias. Six (14%) patients experienced 8 inappropriate shocks for oversensing of cardiac signal (4 cases) and non-cardiac signal (4 cases) with one patient requiring device explantation. No patients had the device explanted due to the need for antitachycardia pacing.

Conclusions: The study shows that S-ICD provides safe and effective therapy for termination of both induced and spontaneous malignant ventricular tachyarrhythmias with high energy shocks in ARVC patients, but the risk of inappropriate shocks and complications needing surgical revision should be considered.
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http://dx.doi.org/10.1016/j.ijcard.2019.01.041DOI Listing
April 2019

Subcutaneous Implantable Cardioverter-Defibrillator in Patients With Arrhythmogenic Right Ventricular Cardiomyopathy/Dysplasia: A Transatlantic Experience.

J Am Heart Assoc 2018 11;7(21):e008782

1 Division of Cardiology Department of Medicine Johns Hopkins Hospital Baltimore MD.

Background Despite growing use of the subcutaneous implantable cardioverter-defibrillator (S- ICD ), its clinical role in arrhythmogenic right ventricular cardiomyopathy/dysplasia ( ARVC /D) patients remains undefined. We aim to elucidate the cardiac phenotype, implant characteristics, and long-term efficacy regarding appropriate therapy and complications in ARVC /D patients with an S- ICD implant. Methods and Results A transatlantic cohort of ARVC /D patients who underwent S- ICD implantation was analyzed for clinical characteristics, S- ICD therapy, and long-term outcome including device-related complications. The cohort included 29 patients (52% male, 76% probands, 59% with ARVC /D-associated mutation, 59% primary prevention [no prior sustained ventricular arrhythmias], and 45% first-generation S- ICD devices). At implant, all inducible patients (27/29) had conversion of induced ventricular fibrillation. Two patients (7%) had superficial infections of the incision site that were treated conservatively. Over a median follow-up of 3.16 years (interquartile range: 2.21-4.51 years), all episodes (6 patients, 4% per year) of sustained ventricular arrhythmias were appropriately detected and treated. Six patients (21%) experienced 39 inappropriate shocks, with 3 requiring device explantation. Oversensing of noncardiac signal (n=4; especially myopotentials) and cardiac signal (n=4) was the most frequent etiology. No lead or device dislodgement, infection, skin erosion, or explantation related to need for antitachycardia pacing was noted. Conclusions S- ICD can effectively treat both induced and spontaneous ventricular arrhythmias in patients with ARVC /D. The rate of inappropriate shocks, although considerable, is comparable to that in ARVC /D patients treated with transvenous ICD s. When they occurred, inappropriate shocks were primarily due to cardiac and, uniquely, noncardiac oversensing. We suggest potential strategies for minimizing inappropriate therapy.
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http://dx.doi.org/10.1161/JAHA.118.008782DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6404172PMC
November 2018

Brugada Syndrome: In Search of a Cause.

J Am Coll Cardiol 2018 12;72(22):2758-2760

Department of Cardiac, Thoracic, and Vascular Sciences, University of Padua, Padua, Italy.

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http://dx.doi.org/10.1016/j.jacc.2018.08.2199DOI Listing
December 2018

Use and outcomes of subcutaneous implantable cardioverter-defibrillator (ICD) after transvenous ICD extraction: An analysis of current clinical practice and a comparison with transvenous ICD reimplantation.

Heart Rhythm 2019 04 24;16(4):564-571. Epub 2018 Oct 24.

Second Cardiology Division, University Hospital of Pisa, Pisa, Italy.

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) does not require the insertion of any leads into the cardiovascular system.

Objective: The aims of the study were to describe current practice and to measure outcomes associated with S-ICD or standard single-chamber transvenous ICD (TV-ICD) use after TV-ICD explantation.

Methods: We analyzed all consecutive patients who underwent transvenous extraction of an ICD and subsequent implantation of an S-ICD or a single-chamber TV-ICD at 12 Italian centers from 2011 to 2017.

Results: A total of 229 patients were extracted and subsequently reimplanted with an S-ICD (90; 39%) or a single-chamber TV-ICD (139; 61%). S-ICD implantation increased from 9% in 2011 to 85% in 2017 (P < .001). Patients reimplanted with an S-ICD were younger (53 ± 13 years vs 60 ± 18 years; P = .011) and more frequently had undergone extraction owing to infection (73% vs 52%; P < .001). The rates of complications at follow-up were comparable between groups (hazard ratio 0.97; 95% confidence interval 0.49-1.92; P = .940). No lead failures, systemic infections, or system-related deaths occurred in the S-ICD group. In the TV-ICD group, 1 lead fracture occurred and 2 systemic infections were reported, resulting in death in 1 case. In the S-ICD group, the rate of complications was lower when the generator was positioned in a sub- or intermuscular pocket (hazard ratio 0.21; 95% confidence interval 0.05-0.87; P = .048).

Conclusion: Our results show an increasing use of S-ICD over the years in patients undergoing TV-ICD explantation. An S-ICD is preferably adopted in young patients, mostly in the case of infection. The complication rate was comparable between groups and decreased when a sub- or intermuscular S-ICD generator position was adopted.
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http://dx.doi.org/10.1016/j.hrthm.2018.10.026DOI Listing
April 2019

Sport activity in patients with implantable defibrillator: Playing with death?

Eur J Prev Cardiol 2019 05 18;26(7):760-763. Epub 2018 Oct 18.

Department of Cardiac, Thoracic, and Vascular Sciences, University of Padua, Italy.

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http://dx.doi.org/10.1177/2047487318805584DOI Listing
May 2019

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

The stricter criteria for Class I CRT indication suggested by the 2016 ESC Guidelines reliably exclude patients with a worse prognosis in comparison with the 2013 ESC indication criteria.

Int J Cardiol 2018 Dec 8;273:162-167. Epub 2018 Sep 8.

Mediterranean Clinic, Naples, Italy.

Background: The European Society of Cardiology (ESC) Guidelines published in 2016 modified indications for cardiac resynchronization therapy (CRT) in comparison with the 2013 ESC Guidelines. The aim of this analysis was to evaluate the impact of the stricter criteria suggested by the 2016 ESC Guidelines on patient outcome in a real-world population.

Methods: We collected data on 930 consecutive patients with complete outcome information who had undergone CRT implantation from 2011 to 2013 from the CRT-MORE registry. Patients were classified according to 2013 (Reference) and 2016 (Current) ESC Guidelines. The primary end-point of the study was death from any cause and heart failure hospitalization.

Results: According to the Reference Guidelines, 650 (69.9%) patients met Class I indications, 190 (20.4%) Class IIa, 39 (4.2%) Class IIb and 51 (5.5%) Class III. According to the Current Guidelines, 563 (60.5%) patients met Class I indications, 145 (15.6%) Class IIa, 108 (11.6%) Class IIb and 114 (12.3%) Class III. On comparing the Reference and Current Guidelines, the 538 patients who confirmed their Class I indication had a better outcome in terms of freedom from the combined end-point of heart failure (HF) hospitalization or death from any cause (hazard ratio (HR) of 0.64; 95% CI 0.42 to 0.99; p = 0.0436) when compared to the 112 patients who lost their class I indication (84 moved to class IIb and 28 moved to class III).

Conclusions: The stricter criteria for Class I CRT indication suggested by the 2016 ESC Guidelines excluded about 20% of patients with a worse prognosis.

Clinical Trial Registration: CRT MORE: Cardiac Resynchronization Therapy Modular Registry URL: http://clinicaltrials.gov/Identifier:NCT01573091.
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http://dx.doi.org/10.1016/j.ijcard.2018.09.027DOI Listing
December 2018