Publications by authors named "Maria Grazia Bongiorni"

167 Publications

Risk stratification of patients undergoing transvenous lead extraction with the ELECTRa Registry Outcome Score (EROS): an ESC EHRA EORP European lead extraction ConTRolled ELECTRa registry analysis.

Europace 2021 Feb 22. Epub 2021 Feb 22.

School of Biomedical Engineering and Imaging Sciences, King's College London, St Thomas' Hospital, London SE1 7EH, UK.

Aims: Transvenous lead extraction is associated with a significant risk of complications and identifying patients at highest risk pre-procedurally will enable interventions to be planned accordingly. We developed the ELECTRa Registry Outcome Score (EROS) and applied it to the ELECTRa registry to determine if it could appropriately risk-stratify patients.

Methods And Results: EROS was devised to risk-stratify patients into low risk (EROS 1), intermediate risk (EROS 2), and high risk (EROS 3). This was applied to the ESC EORP European Lead Extraction ConTRolled ELECTRa registry; 57.5% EROS 1, 31.8% EROS 2, and 10.7% EROS 3. Patients with EROS 3 or 2 were significantly more likely to require powered sheaths and a femoral approach to complete procedures. Patients with EROS 3 were more likely to suffer procedure-related major complications including deaths (5.1 vs. 1.3%; P < 0.0001), both intra-procedural (3.5 vs. 0.8%; P = 0.0001) and post-procedural (1.6 vs. 0.5%; P = 0.0192). They were more likely to suffer post-procedural deaths (0.8 vs. 0.2%; P 0.0449), cardiac avulsion or tear (3.8 vs. 0.5%; P < 0.0001), and cardiovascular lesions requiring pericardiocentesis, chest tube, or surgical repair (4.6 vs. 1.0%; P < 0.0001). EROS 3 was associated with procedure-related major complications including deaths [odds ratio (OR) 3.333, 95% confidence interval (CI) 1.879-5.914; P < 0.0001] and all-cause in-hospital major complications including deaths (OR 2.339, 95% CI 1.439-3.803; P = 0.0006).

Conclusion: EROS successfully identified patients who were at increased risk of significant procedural complications that require urgent surgical intervention.
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http://dx.doi.org/10.1093/europace/euab037DOI Listing
February 2021

Is 40 Joules Enough to Successfully Defibrillate With Subcutaneous Implantable Cardioverter Defibrillators?

JACC Clin Electrophysiol 2021 Jan 21. Epub 2021 Jan 21.

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

Objectives: This study evaluated the efficacy of conversion test performed at 40 J (defibrillation margin ≥40 J), and factors potentially associated with test failure were identified.

Background: Current subcutaneous implantable cardioverter-defibrillator (S-ICD) devices deliver a maximum of 80 J. Functional defibrillation testing is recommended at S-ICD implantation, and it is usually conducted by delivering a shock energy of 65 J to ensure a safety defibrillation margin ≥15 J. Although high rates of successful conversion were reported at 65 J, limited data exist on the defibrillation margin extent.

Methods: Ventricular fibrillation was induced and conversion test was performed by delivering a 40-J shock in 308 patients. Success was defined as termination of ventricular fibrillation by the first shock delivered in standard polarity. The S-ICD system positioning was evaluated with the PRAETORIAN score using bidirectional chest X-rays.

Results: The generator was positioned in an intermuscular pocket in 301 patients (98%) and the lead was implanted by means of a 2-incision technique. The PRAETORIAN score was <90 (low risk of conversion failure) in 293 (95%) patients. Overall, ventricular fibrillation termination occurred in 259 (84%) patients with 40 J. Male gender (odds ratio [OR]: 3.79; 95% confidence interval [CI]: 1.09 to 13.14; p = 0.036), body mass index (OR: 1.09; 95% CI: 1.01 to 1.19; p = 0.036), dilated cardiomyopathy with reduced ejection fraction (OR: 0.42; 95% CI: 0.20 to 0.87; p = 0.019), and PRAETORIAN score >50 (OR: 2.93; 95% CI: 1.26 to 6.83; p = 0.013) were independently associated with conversion failure.

Conclusions: We showed a high rate of defibrillation success with 40-J shocks in S-ICD systems implanted by means of modern surgical techniques. The variables associated with shock failure were male gender, higher body mass index, and suboptimal device position according to the PRAETORIAN score.
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http://dx.doi.org/10.1016/j.jacep.2020.11.001DOI Listing
January 2021

Stereotactic ventricular tachycardia radioablation aided by CT-channels analysis in a patient with inaccessible transmural substrate.

Europace 2021 Jan 19. Epub 2021 Jan 19.

2nd Division of Cardiology, Cardiac Thoracic and Vascular Department, Azienda Ospedaliero Universitaria Pisana, Via Paradisa 2, 56100 Pisa, Italy.

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http://dx.doi.org/10.1093/europace/euaa425DOI Listing
January 2021

Catheter ablation or medical therapy to delay progression of atrial fibrillation: the randomized controlled atrial fibrillation progression trial (ATTEST).

Europace 2021 Mar;23(3):362-369

Department of Cardiology, Asklepios Klinik St. Georg, LANS Cardio, Stephansplatz 5, 20354 Hamburg, Germany.

Aims: Delay of progression from paroxysmal to persistent atrial fibrillation (AF) is an important measure of long-term success of AF treatment. However, published data on the impact of catheter ablation on AF progression are limited. This study evaluates whether radiofrequency (RF) catheter ablation delays the progression of AF compared with antiarrhythmic drug (AAD) treatment using current AF management guidelines.

Methods: This prospective, randomized, controlled, two-arm, open-label trial was conducted at 29 hospitals and medical centres across 13 countries. Patients were randomized 1 : 1 to RF ablation or AAD treatment. The primary endpoint was the rate of persistent AF/atrial tachycardia (AT) at 3 years.

Results: After early study termination following slow enrolment, 255 (79%) of the planned 322 patients were enrolled (RF ablation, n = 128, AAD, n = 127); 36% of patients in the RF ablation group and 41% in the AAD group completed 3 years of follow-up. For the primary endpoint, the Kaplan-Meier estimate of the rate of persistent AF/AT at 3 years was significantly lower with RF ablation [2.4% (95% confidence interval (CI), 0.6-9.4%)] than with AAD therapy [17.5% (95% CI, 10.7-27.9%); one-sided P = 0.0009]. Patients ≥65 years were ∼4 times more likely to progress to persistent AF/AT than patients <65 years, suggesting RF ablation can delay disease progression [hazard ratio: 3.87 (95% CI, 0.88-17.00); P = 0.0727]. Primary adverse events were reported for eight patients in the RF ablation group.

Conclusions: Radiofrequency ablation is superior to guideline-directed AAD therapy in delaying the progression from paroxysmal to persistent AF.
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http://dx.doi.org/10.1093/europace/euaa298DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7947582PMC
March 2021

Risk Factors and Long-Term Survival of Octogenarians and Nonagenarians Undergoing Transvenous Lead Extraction Procedures.

Gerontology 2021 26;67(1):36-48. Epub 2020 Nov 26.

Department of Cardiology, Medical University, Lublin, Poland.

Introduction: Transvenous lead extraction (TLE) has become a frequently used tool for the management of complications related to pacemakers, implantable cardiac defibrillators and cardiac resynchronization therapy devices. However, it is still a matter of debate whether the lead extraction procedure is a safe treatment choice in the elderly.

Methods: We collected the clinical information from 3,810 patients undergoing TLE in 2 high-volume centers (Poland and Italy) between 2006 and 2017. We tested risk factors, effectiveness, safety and long-term survival in 3 groups of patients: those aged 80-89.99 years, ≥90 years and 30-79.99 years.

Results: Lower BMI, lower levels of hemoglobin and more comorbidities characterized the patients, whose ages ranged from 80 to 89.99 years. Those aged ≥90 years most often had single-chamber pacemakers. Octogenarians and nonagenarians were more often undergoing TLE due to infectious indications (57.19 and 74.29 vs. 45.35% in younger individuals). Lead age and the number of leads extracted were comparable in the 3 groups. In octogenarians, leads were more often removed using standard extraction techniques: simple traction and mechanical dilatators, whereas in nonagenarians TLE was more complex. The duration of the procedure was shorter in older patients, while clinical and procedural effectiveness was similar to that in younger individuals. The rate of major complications related to TLE did not differ between octogenarians and younger subjects (2.0 vs. 1.38%, p = ns), and the number of procedure-related risk factors was smaller in older people. Nonagenarians did not develop any major complication related to TLE. Long-term mortality after TLE was similar among octogenarians and nonagenarians (39.67 and 40.00%) but higher than in younger patients (24.41; p < 0.001 and 0.05).

Conclusions: Lead extraction procedures appear effective and safe in octogenarians and nonagenarians, comparable to younger individuals. Procedure-related risk in the elderly is not associated with most of the typical risk factors encountered in younger subjects, but only with the higher number of pacemaker, implantable cardiac defibrillator and cardiac resynchronization therapy device procedures before TLE. Long-term survival after TLE was found to be similar among octogenarians and nonagenarians being about 60% at over 3 years of follow-up. Age alone should not be considered a risk factor for the occurrence of major complications or procedure-related death, and therefore it should not prevent candidacy for TLE.
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http://dx.doi.org/10.1159/000511358DOI Listing
November 2020

Leadless pacing in the elderly: never too old for something new.

Monaldi Arch Chest Dis 2020 Nov 20;90(4). Epub 2020 Nov 20.

Second Department of Cardiology, Cardiac Thoracic and Vascular Department, University Hospital of Pisa.

Rates of cardiac pacemaker implantation rise with age, and, meanwhile, elderly patient may be at great risk of complications, as pneumothorax, lead perforation, or pocket dehiscence. The use of leadless pacemaker could overcome peri- and post-procedural complications related to the presence of transvenous leads and pocket. The study aims to investigate feasibility and outcomes of Micra Transcatheter Pacing System (M-TPS) implantation in elderly, which represents a challenge for conventional cardiac pacing. Between May 2014 and July 2019, 109 patients (88 males, mean age 77.71±9.68 years) underwent M-TPS implantation at our Center, targeting a non-apical site of delivery when feasible. Study population was divided into two groups according to age (group 1 <79 years vs group 2 group 2 ≥80 years). The outcome evaluation included electrical performance at hospital discharge, and during follow-up. In 46/109 cases (34 males, 73.91%) M-TPS was implanted in patients older than 80 years. There were no statistically significant differences between groups for demographics characteristics, except for age. The procedure was performed via the right femoral access in 102/109 cases and was successful in all cases, with no device-related events. No differences were observed between groups in procedure duration, single device delivery, electrical performance at implant and at 12 month F-U. MTP-S implant is an effective and safe procedure in elderly patients, with similar electrical performance and outcome compared with younger patients at mid-term follow-up.
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http://dx.doi.org/10.4081/monaldi.2020.1255DOI Listing
November 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

Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial.

Circulation 2021 Jan 19;143(1):7-17. Epub 2020 Oct 19.

St Antonius Ziekenhuis, Nieuwegein Department of Cardiology, Nieuwegein, The Netherlands (L.V.B.).

Background: The subcutaneous (S) implantable cardioverter-defibrillator (ICD) is safe and effective for sudden cardiac death prevention. However, patients in previous S-ICD studies had fewer comorbidities, had less left ventricular dysfunction, and received more inappropriate shocks (IAS) than in typical transvenous ICD trials. The UNTOUCHED trial (Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction) was designed to evaluate the IAS rate in a more typical, contemporary ICD patient population implanted with the S-ICD using standardized programming and enhanced discrimination algorithms.

Methods: Primary prevention patients with left ventricular ejection fraction ≤35% and no pacing indications were included. Generation 2 or 3 S-ICD devices were implanted and programmed with rate-based therapy delivery for rates ≥250 beats per minute and morphology discrimination for rates ≥200 and <250 beats per minute. Patients were followed for 18 months. The primary end point was the IAS-free rate compared with a 91.6% performance goal, derived from the results for the ICD-only patients in the MADIT-RIT study (Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy). Kaplan-Meier analyses were performed to evaluate event-free rates for IAS, all-cause shock, and complications. Multivariable proportional hazard analysis was performed to determine predictors of end points.

Results: S-ICD implant was attempted in 1116 patients, and 1111 patients were included in postimplant follow-up analysis. The cohort had a mean age of 55.8±12.4 years, 25.6% were women, 23.4% were Black, 53.5% had ischemic heart disease, 87.7% had symptomatic heart failure, and the mean left ventricular ejection fraction was 26.4±5.8%. Eighteen-month freedom from IAS was 95.9% (lower confidence limit, 94.8%). Predictors of reduced incidence of IAS were implanting the most recent generation of device, using the 3-incision technique, no history of atrial fibrillation, and ischemic cause. The 18-month all-cause shock-free rate was 90.6% (lower confidence limit, 89.0%), meeting the prespecified performance goal of 85.8%. Conversion success rate for appropriate, discrete episodes was 98.4%. Complication-free rate at 18 months was 92.7%.

Conclusions: This study demonstrates high efficacy and safety with contemporary S-ICD devices and programming despite the relatively high incidence of comorbidities in comparison with earlier S-ICD trials. The inappropriate shock rate (3.1% at 1 year) is the lowest reported for the S-ICD and lower than many transvenous ICD studies using contemporary programming to reduce IAS. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02433379.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.048728DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7752215PMC
January 2021

Prospective use of ablation index for the ablation of right ventricle outflow tract premature ventricular contractions: a proof of concept study.

Europace 2021 Jan;23(1):91-98

Heart Rhythm Center, Centro Cardiologico Monzino, IRCCS, Milan, IT, Italy.

Aims: Radiofrequency catheter ablation (RFCA) represents an effective option for idiopathic premature ventricular contractions (PVCs) treatment. Ablation Index (AI) is a novel ablation marker incorporating RF power, contact force, and time of delivery into a single weighted formula. Data regarding AI-guided PVCs RFCA are currently lacking. Aim of the study was to compare AI-guided and standard RFCA outcomes in patients with PVCs originating from the right ventricle outflow tract (RVOT).

Methods And Results: Consecutive patients undergoing AI-guided RFCA of RVOT idiopathic PVCs were prospectively enrolled. Radiofrequency catheter ablation was performed following per-protocol target cut-offs of AI, depending on targeted area (RVOT free wall AI cut-off: 590; RVOT septum AI cut-off: 610). A multi-centre cohort of propensity-matched (age, sex, ejection fraction, and PVC site) patients undergoing standard PVCs RFCA was used as a comparator. Sixty AI-guided patients (44.2 ± 18.0 years old, 58% male, left ventricular ejection fraction 56.2 ± 3.8%) were enrolled; 34 (57%) were ablated in RVOT septum and 26 (43%) patients in the RVOT free wall area. Propensity match with 60 non-AI-guided patients was performed. Acute outcomes and complications resulted comparable. At 6 months, arrhythmic recurrence was more common in non-AI-guided patients whether in general (28% vs. 7% P = 0.003) or by ablated area (RVOT free wall: 27% vs. 4%, P = 0.06; RVOT septum 29% vs. 9% P = 0.05). Ablation Index guidance was associated with improved survival from arrhythmic recurrence [overall odds ratio 6.61 (1.95-22.35), P = 0.001; RVOT septum 5.99 (1.21-29.65), P = 0.028; RVOT free wall 11.86 (1.12-124.78), P = 0.039].

Conclusion: Ablation Index-guidance in idiopathic PVCs ablation was associated with better arrhythmic outcomes at 6 months of follow-up.
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http://dx.doi.org/10.1093/europace/euaa228DOI Listing
January 2021

[Clinical pathway for electrical storm treatment in a healthcare network modeling. A proposal from ANMCO Tuscany].

G Ital Cardiol (Rome) 2020 Oct;21(10):768-778

U.O.C. Cardiologia, Nuovo Ospedale Versilia, USL Toscana Nord Ovest, Lido di Camaiore (LU).

Electrical storm (ES) is defined as three or more episodes of sustained ventricular tachycardia (VT) or fibrillation (VF) within 24 h, or an incessant VT/VF lasting more than 12 h. It usually occurs in implantable cardioverter-defibrillator (ICD) recipients, and three or more device interventions are typically used for the diagnosis. ES incidence is particularly high in case of ICD implanted in secondary prevention (10-30%), with recurrences occurring in up to 80% of patients. A comprehensive evaluation of triggers, predictive factors of high-risk patients and an appropriate management of the acute/subacute and chronic phases are pivotal to reduce mortality and recurrences. Medical therapy with antiarrhythmic and anesthetic drugs, with appropriate device reprogramming and neuroaxial modulation if needed, are used to cool down the ES, which should ultimately be treated with ablation therapy or, less often, with an alternative treatment, such as denervation or stereotactic radiosurgery. An optimization of the clinical pathway in a network modeling is crucial to achieve the best treatment, eventually addressing patients to centers with VT ablation programs, and identifying the most challenging procedures and the most critical patients that should be treated only in high-volume tertiary centers. In this paper, we present a proposal of healthcare network modeling for ES treatment in a regional setting.
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http://dx.doi.org/10.1714/3431.34203DOI Listing
October 2020

High-density mapping of Koch's triangle during sinus rhythm and typical AV nodal reentrant tachycardia: new insight.

J Interv Card Electrophysiol 2020 Aug 6. Epub 2020 Aug 6.

Second Department of Cardiology, Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy.

Background: Atrial activation during typical atrioventricular nodal reentrant tachycardia (AVNRT) exhibits anatomic variability and spatially heterogeneous propagation inside the Koch's triangle (KT). The mechanism of the reentrant circuit has not been elucidated yet. Aim of this study is to describe the distribution of Jackman and Haïssaguerre potentials within the KT and to explore the activation mode of the KT, in sinus rhythm and during the slow-fast AVNRT.

Methods: Forty-five consecutive cases of successful slow pathway (SP) ablation of typical slow-fast AVNRT from the CHARISMA registry were included.

Results: The KT geometry was obtained on the basis of the electroanatomic information using the Rhythmia mapping system (Boston Scientific) (mean number of points acquired inside the KT = 277 ± 47, mean mapping time = 11.9 ± 4 min). The postero-septal regions bounded anteriorly by the tricuspid annulus and posteriorly by the lateral wall toward the crista terminalis showed a higher prevalence of Jackman potentials than mid-postero-septal regions along the tendon of Todaro and coronary sinus (CS) (98% vs. 16%, p < 0.0001). Haïssaguerre potentials seemed to have a converse distribution across the KT (0% vs. 84%, p < 0.0001). Fast pathway insertion, as located during AVNRT, was mostly recorded in an antero-septal position (n = 36, 80%), rather than in a mid-septal (n = 6, 13.3%) or even postero-septal (n = 3, 7%) location. During typical slow-fast AVNRT, two types of propagation around the CS were discernible: anterior and posterior, n = 31 (69%), or only anterior, n = 14 (31%). During the first procedure, the SP was eliminated, and acute procedural success was achieved (median of 4 [3-5] RF ablations).

Conclusion: High-density mapping of KT in AVNRT patients both during sinus rhythm and during tachycardia provides new electrophysiological insights. A better understanding and a more precise definition of the arrhythmogenic substrate in AVNRT patients may have prognostic value, especially in high-risk cases.

Trial Registration: Catheter Ablation of Arrhythmias With High Density Mapping System in the Real World Practice (CHARISMA) URL: http://clinicaltrials.gov/ Identifier: NCT03793998.
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http://dx.doi.org/10.1007/s10840-020-00841-8DOI Listing
August 2020

Comparison between leadless and transvenous single-chamber pacemaker therapy in a referral centre for lead extraction.

J Interv Card Electrophysiol 2020 Jul 25. Epub 2020 Jul 25.

Second Department of Cardiology, Cardiac Thoracic and Vascular Department, University Hospital of Pisa, Via Paradisa, 2, Cisanello, 56124, Pisa, Italy.

Purpose: The aim of the study was to compare the long-term clinical and electrical performance of Micra leadless pacemaker with transvenous single-chamber pacemaker (TV-VVI PM) in a high-volume centre for transvenous lead extraction (TLE).

Methods: One-hundred patients (group 1) undergoing Micra implant were matched with 100 patients undergoing TV-VVI PM implant (group 2) by age, sex, left ventricular systolic ejection fraction and previous TLE.

Results: The implant procedure was successful in all patients. In group 1, the procedure duration was lower than in group 2 (43.86 ± 22.38 vs 58.38 ± 17.85 min, p < 0.001), while the fluoroscopy time was longer (12.25 ± 6.84 vs 5.32 ± 4.42 min, p < 0.001). There was no difference about the rate of septal implant at the right ventricle (76% vs 86%, p = 0.10). Patients were followed-up for a median of 12 months. No acute and chronic procedure-related complication was observed in group 1, while we reported acute complications in seven patients (7%, p = 0.02) and long-term complications in three patients (3%, p = 0.24), needing for a system revision in 6 cases (6%, p = 0.038), in group 2. One systemic infection occurred in TV-VVI PM group. Electrical measurements were stable during follow-up in both groups, with a longer estimated battery life in group 1 (mean delivered energy at threshold at discharge: 0.14 ± 0.21 vs 0.26 ± 0.22 μJ, p < 0.001).

Conclusion: Micra pacemaker implant is a safe and effective procedure, with a lower rate of acute complications and system revisions compared with TV-VVI PM, even in a real-life setting including patients who underwent TLE.
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http://dx.doi.org/10.1007/s10840-020-00832-9DOI Listing
July 2020

The effect of centre volume and procedure location on major complications and mortality from transvenous lead extraction: an ESC EHRA EORP European Lead Extraction ConTRolled ELECTRa registry subanalysis.

Europace 2020 11;22(11):1718-1728

Department of Biomedical Engineering and Imaging Sciences, King's College London, London, UK.

Aims: Transvenous lead extraction (TLE) should ideally be undertaken by experienced operators in a setting that allows urgent surgical intervention. In this analysis of the ELECTRa registry, we sought to determine whether there was a significant difference in procedure complications and mortality depending on centre volume and extraction location.

Methods And Results: Analysis of the ESC EORP European Lead Extraction ConTRolled ELECTRa registry was conducted. Low-volume (LoV) centres were defined as <30 procedures/year, and high-volume (HiV) centres as ≥30 procedures/year. Three thousand, two hundred, and forty-nine patients underwent TLE by a primary operator cardiologist; 17.1% in LoV centres and 82.9% in HiV centres. Procedures performed by primary operator cardiologists in LoV centres were less likely to be successful (93.5% vs. 97.1%; P < 0.0001) and more likely to be complicated by procedure-related deaths (1.1% vs. 0.4%; P = 0.0417). Transvenous lead extraction undertaken by primary operator cardiologists in LoV centres were associated with increased procedure-related major complications including death (odds ratio 1.858, 95% confidence interval 1.007-3.427; P = 0.0475). Transvenous lead extraction locations varied; 52.0% operating room, 9.5% hybrid theatre and 38.5% catheterization laboratory. Rates of procedure-related major complications, including death occurring in a high-risk environment (combining operating room and hybrid theatre), were similar to those undertaken in the catheterization laboratory (1.7% vs. 1.6%; P = 0.9297).

Conclusion: Primary operator cardiologists in LoV centres are more likely to have extractions complicated by procedure-related deaths. There was no significant difference in procedure complications between different extraction settings. These findings support the need for TLE to be performed in experienced centres with appropriate personnel present.
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http://dx.doi.org/10.1093/europace/euaa131DOI Listing
November 2020

Safety and efficacy of transvenous mechanical lead extraction in patients with abandoned leads.

Europace 2020 09;22(9):1401-1408

Cardiology Department, University Hospital of Pisa, Via Paradisa 2, 56124 Pisa, Italy.

Aims: Optimal management of redundant or malfunctioning leads is controversial. We aimed to assess safety and efficacy of mechanical transvenous lead extraction (TLE) in patients with abandoned leads.

Methods And Results: Consecutive TLE procedures performed in our centre from January 2009 to December 2017 were considered. We evaluated the safety and efficacy of mechanical TLE in patients with abandoned (Group 1) compared to non-abandoned (Group 2) leads. We analysed 1210 consecutive patients that required transvenous removal of 2343 leads. Group 1 accounted for 250 patients (21%) with a total of 617 abandoned leads (26%). Group 2 comprised 960 patients (79%) with 1726 leads (74%). The total number of leads (3.0 vs. 2.0), dwelling time of the oldest lead (108.00 months vs. 60.00 months) and infectious indications for TLE were higher in Group 1. Clinical success was achieved in 1168 patients (96.5%) with a lower rate in Group 1 (90.4% vs. 98.1%; P < 0.001). Major complications occurred in only 9 patients (0.7%), without significant differences among the two groups. The presence of one or more abandoned leads [odds ratio (OR) 3.47; 95% confidence interval (CI) 1.07-11.19; P = 0.037] and dwelling time of the oldest lead (OR 1.01 for a month; 95% CI 1.01-1.02; P < 0.001) were associated with a higher risk of clinical failure.

Conclusion: Transvenous mechanical lead extraction is a safe procedure also in high-risk settings, as patients with abandoned leads. Success rate resulted a bit lower, especially in the presence of abandoned leads with long implantation time.
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http://dx.doi.org/10.1093/europace/euaa134DOI Listing
September 2020

A novel local impedance algorithm to guide effective pulmonary vein isolation in atrial fibrillation patients: Preliminary experience across different ablation sites from the CHARISMA pilot study.

J Cardiovasc Electrophysiol 2020 09 9;31(9):2319-2327. Epub 2020 Jul 9.

Laboratorio di Elettrofisiologia, Clinica Montevergine, Mercogliano, Avellino, Italy.

Introduction: Recently, a novel technology able to measure local impedance (LI) and tissue characteristics has been made available for clinical use. This analysis explores the relationships among LI and generator impedance (GI) parameters in atrial fibrillation (AF) patients. Characterization of LI among different ablation spots and procedural success were also evaluated.

Methods And Results: Consecutive patients undergoing AF ablation from the CHARISMA registry at five Italian centers were included. A novel radiofrequency (RF) ablation catheter with a dedicated algorithm (DIRECTSENSE™) was used to measure LI and to guide ablation. The ablation endpoint was pulmonary vein (PV) isolation. We analyzed 2219 ablation spots created around PVs in 46 patients for AF ablation. The mean baseline tissue impedance was 105.8 ± 14 Ω for LI versus 91.8 ± 10 Ω for GI (p < .0001). Baseline impedance was homogenous across the PV sites and proved higher in high-voltage areas than in intermediate- and low-voltage areas and the blood pool (p < .001). Both LI and GI displayed a significant drop after RF delivery, and absolute LI drop values were significantly larger than GI drop values (14 ± 8 vs. 3.7 ± 5 Ω, p < .0001). Every 5-point increment in LI drop was associated with successful ablation (odds ratio = 3.05, 95% confidence interval: 2.3-4.1, p < .0001). Conversely, GI drops were not significantly different comparing successful versus unsuccessful sites (3.7 ± 5 vs. 2.8 ± 4 Ω, p = .1099). No steam pops or major complications occurred during or after the procedures. By the end of the procedures, all PVs had been successfully isolated in all patients.

Conclusions: The magnitude of the LI drop was more closely associated with effective lesion formation than the GI drop.
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http://dx.doi.org/10.1111/jce.14647DOI Listing
September 2020

Predictors of zero X ray procedures in supraventricular arrhythmias ablation.

Int J Cardiovasc Imaging 2020 Sep 23;36(9):1599-1607. Epub 2020 May 23.

Second Division of Cardiology, Cardiac-Thoracic-Vascular Department, New Santa Chiara Hospital, Azienda Ospedaliero Universitaria Pisana, Via Paradisa 2, 56124, Pisa, Italy.

To evaluate predictors of zero-X ray procedures for supraventricular arrhythmias (SVT) using minimally fluoroscopic approach (MFA). Patients referred for RF catheter ablation of SVT were admitted for a MFA with an electro-anatomical navigation system or a conventional fluoroscopic approach (ConvA). Exclusion criterion was the need to perform a transseptal puncture. 206 patients (98 men, age 53 ± 19 years) underwent an EP study, 93 (45%) with an MFA and 113 (55%) with a ConvA. Fifty-five had no inducible arrhythmias (EPS). Fifty-four had AV nodal reentrant tachycardia (AVNRT), 49 patients had typical atrial flutter (AFL), 37 had AV reciprocating tachycardia (AVRT/WPW), 11 had focal atrial tachycardia (AT), and underwent a RF ablation. X-ray was not used at all in 51/93 (58%) procedures (zero X ray). MFA was associated with a significant reduction in total fluoroscopy time (5.5 ± 10 vs 13 ± 18 min, P = 0.01) and operator radiation dose (0.8 ± 2.5 vs 3 ± 8.2 mSV, P < 0.05). The greatest absolute dose reduction was observed in AVNRT (0.1 ± 0.3 vs 5.1 ± 10 mSV, P = 0.01, 98% relative dose reduction) and in AFL (1.3 ± 3.6 vs 11 ± 16 mSV, P = 0.003, 88% relative dose reduction) groups. Both AVNRT or AFL resulted the only statistically significant predictors of zero x ray at multivariate analysis (OR 4.5, 95% CI 1.5-13 and OR 5, 95% CI 1.7-15, P < 0.001, respectively). Success and complication rate was comparable between groups (P = NS). Using MFA for SVT ablation, radiological exposure is significantly reduced. Type of arrhythmia is the strongest predictor of zero X ray procedure.
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http://dx.doi.org/10.1007/s10554-020-01884-8DOI Listing
September 2020

Role of pre-procedural CT imaging on catheter ablation in patients with atrial fibrillation: procedural outcomes and radiological exposure.

J Interv Card Electrophysiol 2020 May 13. Epub 2020 May 13.

Second Division of Cardiology, New Santa Chiara Hospital Cardiac-Thoracic-Vascular Department, Azienda Ospedaliero Universitaria Pisana, Via Paradisa 2, 56124, Pisa, Italy.

Background: Cardiac computed tomography (CT) is commonly used to study left atrial (LA) and pulmonary veins (PVs) anatomy before atrial fibrillation (AF) ablation. The aim of the study was to determine the impact of pre-procedural cardiac CT with 3D reconstruction on procedural outcomes and radiological exposure in patients who underwent radiofrequency catheter ablation (RFA) of AF.

Methods: In this registry, 493 consecutive patients (age 62 ± 8 years, 70% male) with paroxysmal (316) or persistent (177) AF who underwent first procedure of RFA were included. A pre-procedural CT scan was obtained in 324 patients (CT group). Antral pulmonary vein isolation was performed in all patients using an open-irrigation-tip catheter with a 3D electroanatomical navigation system. Procedural outcome, including radiological exposure, and clinical outcomes were compared among patients who underwent RFA with (CT group) and without (no CT group) pre-procedural cardiac CT.

Results: Acute PV isolation was obtained in all patients, with a comparable overall complication rate between CT and no CT group (4.3% vs 3%, p = 0.7). No differences were observed about mean duration of the procedure (231 ± 60 vs 233 ± 58 min, p = 0.7) and fluoroscopy time (13 ± 10 vs 13 ± 8 min, p = 0.6) among groups. Cumulative radiation dose resulted significantly higher in the CT group compared with no CT group (8.9 ± 24 vs 4.8 ± 15 mSv, P = 0.02). At 1 year, freedom from AF/atrial tachycardia were comparable among groups (CT group, 227/324 (70%), vs no CT group,119/169 (70%), p = ns).

Conclusions: Pre-procedural CT does not improve safety and efficacy of AF ablation, increasing significantly the cumulative radiological exposure.
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http://dx.doi.org/10.1007/s10840-020-00764-4DOI Listing
May 2020

Performance of a novel active fixation quadripolar left ventricular lead for cardiac resynchronization therapy: Attain Stability Quad Clinical Study results.

J Cardiovasc Electrophysiol 2020 05 18;31(5):1147-1154. Epub 2020 Mar 18.

Division of Cardiology, Vanderbilt University Heart and Vascular Institute, Nashville, Tennessee.

Introduction: The Medtronic Attain Stability Quad lead is a quadripolar left ventricular (LV) lead with an active fixation helix assembly designed to fixate the lead within the coronary sinus and pace nonapical regions of the LV. The primary objective of this study was to determine the safety and effectiveness of this novel active fixation quadripolar LV lead.

Methods: Patients with standard indications for cardiac resynchronization therapy (CRT) were enrolled. All patients were followed at 3 and 6 months post-implant and every 6 months thereafter until study closure. Pacing capture thresholds (PCTs) were measured at implant and each follow-up and adverse events (AEs) were recorded upon occurrence.

Results: Of the 440 patients who underwent implant procedures, placement of the Attain Stability Quad lead was successful in 426 (96.8%). LV lead-related complications occurred in 10 patients (2.3%), including LV lead dislodgement in three patients (0.7%). The percentage of patients with at least one LV pacing vector with a PCT ≤2.5 V at a 6-month follow-up was 96.3%. The LV lead was successfully fixated to the prespecified pacing location in 97.4% of cases.

Conclusions: This large, multinational study of the Attain Stability Quad lead demonstrated a high rate of implant success with a low complication rate. The active fixation mechanism allowed precise placement of the pacing electrodes at the desired target region with good PCTs and a very low dislodgement rate.
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http://dx.doi.org/10.1111/jce.14439DOI Listing
May 2020

Transvenous lead extraction: Efficacy and safety of the procedure in octogenarian patients.

Pacing Clin Electrophysiol 2020 04 3;43(4):382-387. Epub 2020 Apr 3.

Cardiology Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.

Background: Managing elderly patients with infection or malfunction deriving from a cardiac implantable electronic device (CIED) may be challenging. The aim of this study was to evaluate safety and efficacy of mechanical transvenous lead extraction (TLE) in elderly patients.

Methods: Patients who had undergone TLE in single tertiary referral center were divided in two groups (group 1: ≥ 80 years; group 2: < 80 years) and their acute and chronic outcomes were compared. All patients were treated with manual traction or mechanical dilatation.

Results: Our analysis included 1316 patients (group 1: 202; group 2: 1114 patients), with a total of 2513 leads extracted. Group 1 presented more comorbidities, more pacemakers than implantable cardioverter-defibrillators, whereas the dwelling time of the oldest lead and the number of leads were similar, irrespective of patient's age. In group 1, the radiological success rate for lead was higher (99.0% vs 95.9%; P < .001) and the fluoroscopy time lower (13.0 vs 15.0 min; P = .04) than in group 2. Clinical success was reached in 1273 patients (96.7%), without significant differences between groups (group 1: 98.0% vs group 2: 96.4%; P = .36). Major complications occurred in 10 patients (0.7%) without significative differences between patients with more or less than 80 years (group 1: 1.5% vs group 2: 0.6%; P = .24) and with no procedure-related deaths in elderly group.

Conclusions: Mechanical TLE in elderly patients is a safe and effective procedure. In the over-80s, a comparable incidence of major complications with younger patients was observed, with at least a similar efficacy of the procedure.
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http://dx.doi.org/10.1111/pace.13896DOI Listing
April 2020

European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections-endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), International Society for Cardiovascular Infectious Diseases (ISCVID), and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS).

Eur Heart J 2020 06;41(21):2012-2032

Department of Cardiology, Royal Melbourne Hospital, 300 Grattan St, Parkville VIC 3050, Melbourne, Australia.

Pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices are potentially lifesaving treatments for a number of cardiac conditions but are not without risk. Most concerning is the risk of a cardiac implantable electronic device (CIED) infection, which is associated with significant morbidity, increased hospitalizations, reduced survival, and increased health care costs. Recommended preventive strategies such as administration of intravenous antibiotics before implantation are well-recognized. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, antibacterial envelopes, prolonged antibiotics post-implantation, and others. When compared with previous guidelines or consensus statements, the present consensus document gives guidance on the use of novel device alternatives, novel oral anticoagulants, antibacterial envelopes, prolonged antibiotics post-implantation, as well as definitions on minimum quality requirements for centres and operators and volumes. The recognition that an international consensus document focused on management of CIED infections is lacking, the dissemination of results from new important randomized trials focusing on prevention of CIED infections, and observed divergences in managing device-related infections as found in an European Heart Rhythm Association worldwide survey, provided a strong incentive for a Novel 2019 International State-of-the-art Consensus document on risk assessment, prevention, diagnosis, and treatment of CIED infections.
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http://dx.doi.org/10.1093/eurheartj/ehaa010DOI Listing
June 2020

European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections-endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), International Society for Cardiovascular Infectious Diseases (ISCVID) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS).

Eur J Cardiothorac Surg 2020 01;57(1):e1-e31

Department of Cardiology, Royal Melbourne Hospital, Melbourne, Australia.

Pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices are potentially life-saving treatments for a number of cardiac conditions, but are not without risk. Most concerning is the risk of a cardiac implantable electronic device (CIED) infection, which is associated with significant morbidity, increased hospitalizations, reduced survival, and increased healthcare costs. Recommended preventive strategies such as administration of intravenous antibiotics before implantation are well recognized. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, anti-bacterial envelopes, prolonged antibiotics post-implantation, and others. Guidance on whether to use novel device alternatives expected to be less prone to infections and novel oral anticoagulants is also limited, as are definitions on minimum quality requirements for centres and operators and volumes. Moreover, an international consensus document on management of CIED infections is lacking. The recognition of these issues, the dissemination of results from important randomized trials focusing on prevention of CIED infections, and observed divergences in managing device-related infections as found in an European Heart Rhythm Association worldwide survey, provided a strong incentive for a 2019 International State-of-the-art Consensus document on risk assessment, prevention, diagnosis, and treatment of CIED infections.
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http://dx.doi.org/10.1093/ejcts/ezz296DOI Listing
January 2020

European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections-endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), International Society for Cardiovascular Infectious Diseases (ISCVID) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS).

Europace 2020 04;22(4):515-549

Department of Cardiology, Royal Melbourne Hospital, Melbourne, Australia.

Pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices are potentially life-saving treatments for a number of cardiac conditions, but are not without risk. Most concerning is the risk of a cardiac implantable electronic device (CIED) infection, which is associated with significant morbidity, increased hospitalizations, reduced survival, and increased healthcare costs. Recommended preventive strategies such as administration of intravenous antibiotics before implantation are well recognized. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, anti-bacterial envelopes, prolonged antibiotics post-implantation, and others. Guidance on whether to use novel device alternatives expected to be less prone to infections and novel oral anticoagulants is also limited, as are definitions on minimum quality requirements for centres and operators and volumes. Moreover, an international consensus document on management of CIED infections is lacking. The recognition of these issues, the dissemination of results from important randomized trials focusing on prevention of CIED infections, and observed divergences in managing device-related infections as found in an European Heart Rhythm Association worldwide survey, provided a strong incentive for a 2019 International State-of-the-art Consensus document on risk assessment, prevention, diagnosis, and treatment of CIED infections.
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http://dx.doi.org/10.1093/europace/euz246DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7132545PMC
April 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

Transvenous lead extraction procedures in women based on ESC-EHRA EORP European Lead Extraction ConTRolled ELECTRa registry: is female sex a predictor of complications?

Europace 2019 12;21(12):1890-1899

Direttore UO Cardiologia 2 SSN, Azienda Ospedaliero-Universitaria, Pisa, Italy.

Aims: Female sex is considered an independent risk factor of transvenous leads extraction (TLE) procedure. The aim of the study was to evaluate the effectiveness of TLE in women compared with men.

Methods And Results: A post hoc analysis of risk factors and effectiveness of TLE in women and men included in the ESC-EHRA EORP ELECTRa registry was conducted. The rate of major complications was 1.96% in women vs. 0.71% in men; P = 0.0025. The number of leads was higher in men (mean 1.89 vs. 1.71; P < 0.0001) with higher number of abandoned leads in women (46.04% vs. 34.82%; P < 0.0001). Risk factors of TLE differed between the sexes, of which the major were: signs and symptoms of venous occlusion [odds ratio (OR) 3.730, confidence interval (CI) 1.401-9.934; P = 0.0084], cumulative leads dwell time (OR 1.044, CI 1.024-1.065; P < 0.001), number of generator replacements (OR 1.029, CI 1.005-1.054; P = 0.0184) in females and the number of leads (OR 6.053, CI 2.422-15.129; P = 0.0001), use of powered sheaths (OR 2.742, CI 1.404-5.355; P = 0.0031), and white blood cell count (OR 1.138, CI 1.069-1.212; P < 0.001) in males. Individual radiological and clinical success of TLE was 96.29% and 98.14% in women compared with 98.03% and 99.21% in men (P = 0.0046 and 0.0098).

Conclusion: The efficacy of TLE was lower in females than males, with a higher rate of periprocedural major complications. The reasons for this difference are probably related to disparities in risk factors in women, including more pronounced leads adherence to the walls of the veins and myocardium. Lead management may be key to the effectiveness of TLE in females.
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http://dx.doi.org/10.1093/europace/euz277DOI Listing
December 2019

Comparison of outcomes in infected cardiovascular implantable electronic devices between complete, partial, and failed lead removal: an ESC-EHRA-EORP ELECTRa (European Lead Extraction ConTrolled) registry.

Europace 2019 12;21(12):1876-1889

Integrated Heart Center, Shaare Zedek Medical Center, Jerusalem, Israel.

Aims: The present study sought to determine predictors for success and outcomes of patients who underwent cardiac implantable electronic devices (CIED) extraction indicated for systemic or local CIED related infection in particular where complete lead removal could not be achieved.

Methods And Results: ESC-EORP ELECTRa (European Lead Extraction ConTRolled Registry) is a European prospective lead extraction registry. Out of the total cohort, 1865/3510 (52.5%) patients underwent removal due to CIED related infection. Predictors and outcomes of failure were analysed. Complete removal was achieved in 1743 (93.5%) patients, partial (<4 cm of lead left) in 88 (4.7%), and failed (>4 cm of lead left) in 32 (1.8%) patients. Removal success was unrelated to type of CIED infection (pocket or systemic). Predictors for failure were older leads and older patients [odds ratio (OR) 1.14 (1.08-1.19), P < 0.0001 and OR 2.68 (1.22-5.91), P = 0.0146, respectively]. In analysis by lead, predictors for failure were: pacemaker vs. defibrillator removal and failure to engage the locking stylet all the way to the tip [OR 0.20 (0.04-0.95), P = 0.03 and OR 0.32 (0.13-0.74), P = 0.008, respectively]. Significantly higher complication rates were noted in the failure group (40.6% vs. 15.9 for partial and 8.7% for success groups, P < 0.0001). Failure to remove a lead was a strong predictor for in hospital mortality [hazard ratio of 2.05 (1.01-4.16), P = 0.046].

Conclusion: A total of 6.5% of infected CIED patients failed attempted extraction. Only were >4 cm of lead remained resulted in higher procedural complications and mortality rates.
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http://dx.doi.org/10.1093/europace/euz269DOI Listing
December 2019

Clinical impact of antithrombotic therapy in transvenous lead extraction complications: a sub-analysis from the ESC-EORP EHRA ELECTRa (European Lead Extraction ConTRolled) Registry.

Europace 2019 Jul;21(7):1096-1105

Second Division of Cardiology, Department of Cardiac-Thoracic & Vascular, Azienda Ospedaliera Pisana, Via Paradisa 2, Pisa, Italy.

Aims: A sub-analysis of the ESC-EHRA European Lead Extraction ConTRolled (ELECTRa) Registry to evaluate the clinical impact of antithrombotic (AT) on transvenous lead extraction (TLE) safety and efficacy.

Methods And Results: ELECTRa outcomes were compared between patients without AT therapy (No AT Group) and with different pre-operative AT regimens, including antiplatelets (AP), anticoagulants (AC), or both (AP + AC). Out of 3510 pts, 2398 (68%) were under AT pre-operatively. AT patients were older with more comorbidities (P < 0.0001). AT subgroups, defined as AP, AC, or AP + AC, were 1096 (31.2%), 985 (28%), and 317 (9%), respectively. Regarding AP patients, 1413 (40%) were under AP, 1292 (91%) with a single AP, interrupted in 26% about 3.8 ± 3.7 days before TLE. In total, 1302 (37%) patients were under AC, 881 vitamin K antagonist (68%), 221 (17%) direct oral anticoagulants, 155 (12%) low weight molecular heparin, and 45 (3.5%) unfractionated heparin. AC was 'interrupted without bridging' in 696 (54%) and 'interrupted with bridging' in 504 (39%) about 3.3 ± 2.3 days before TLE, and 'continued' in 87 (7%). TLE success rate was high in all subgroups. Only overall in-hospital death (1.4%), but not the procedure-related one, was higher in the AT subgroups (P = 0.0500). Age >65 years and New York Heart Association Class III/IV, but not AT regimens, were independent predictors of death for any cause. Haematomas were more frequent in AT subgroups, especially in AC 'continued' (P = 0.025), whereas pulmonary embolism in the No-AT (P < 0.01).

Conclusions: AT minimization is safe in patients undergoing TLE. AT does not seem to predict death but identifies a subset of fragile patients with a worse in-hospital TLE outcome.
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http://dx.doi.org/10.1093/europace/euz062DOI Listing
July 2019

Clinical practice and implementation of guidelines for the prevention, diagnosis and management of cardiac implantable electronic device infections: results of a worldwide survey under the auspices of the European Heart Rhythm Association.

Europace 2019 Aug;21(8):1270-1279

Department of Medical Science and Cardiology, Uppsala University, Uppsala, Sweden.

Aims: Cardiac implantable electronic device (CIED) infection rates are increasing. Worldwide compliance and disparities to published guidelines for the prevention, diagnosis and management of these conditions are not well elucidated. The purpose of this survey, therefore, was to clarify these issues through an inquiry to arrhythmia-related associations and societies worldwide.

Methods And Results: A questionnaire comprising 15 questions related to CIED infections was distributed among members of seven arrhythmia societies worldwide. A total of 234 centres in 62 countries reported implantation rates of which 159 (68.0%) performed more than 200 device implantations per year and 14 (6.0%) performed fewer than 50 implantations per year. The reported rates of CIED infections for 2017 were ≤2% in 78.7% of the centres, while the infection rates exceeded 5% in 7.8% of the centres. Preventive measures for CIED infection differed from published recommendations and varied among different regions mainly in terms of pocket irrigation and administering post-operative antimicrobial therapy the use of which was reported by 39.9% and 44% of the respondents, respectively. Antibacterial envelopes were used by 37.7% of the respondents in selected circumstances. In terms of pocket infection management, 62% of the respondents applied complete system removal as an initial step. Diagnostic pocket needle aspiration and pocket surgical debridement were reported by 15.8% and 11.8% of centres, respectively.

Conclusion: Clinical practices for prevention and management of CIED do not fully comply with current recommendations and demonstrate considerable regional disparities. Further education and programmes for improved implementation of guidelines are mandatory.
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http://dx.doi.org/10.1093/europace/euz137DOI Listing
August 2019

Cardiac implantable electronic device infection: more risks, more effort for its prevention?

Eur Heart J 2019 06;40(23):1870-1872

Second Division of Cardiology, Cardiothoracic and Vascular Department, University Hospital of Pisa, Cisanello, Italy.

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http://dx.doi.org/10.1093/eurheartj/ehz407DOI Listing
June 2019

Micra pacemaker implant after cardiac implantable electronic device extraction: feasibility and long-term outcomes.

Europace 2019 Aug;21(8):1229-1236

Second Department of Cardiology, Cardiothoracic and Vascular Department - University Hospital of Pisa, Via Paradisa, 2, Pisa, Italy.

Aims: We aimed at investigating the feasibility and outcome of Micra implant in patients who have previously undergone transvenous lead extraction (TLE), in comparison to naïve patients implanted with the same device.

Methods And Results: Eighty-three patients (65 males, 78.31%; 77.27 ± 9.96 years) underwent Micra implant at our centre. The entire cohort was divided between 'post-extraction' (Group 1) and naïve patients (Group 2). In 23 of 83 patients (20 males, 86.96%; 73.83 ± 10.29 years), Micra was implanted after TLE. Indication to TLE was an infection in 15 patients (65.21%), leads malfunction in four (17.39%), superior vena cava syndrome in three (13.05%), and severe tricuspid regurgitation in one case (4.35%). The implant procedure was successful in all patients and no device-related events occurred at follow-up (median: 18 months; interquartile range: 1-24). No differences were observed between groups in fluoroscopy time (13.88 ± 10.98 min vs. 13.15 ± 6.64 min, P = 0.45), single device delivery (Group 1 vs. Group 2: 69.56% vs. 55%, P = 0.22), electrical performance at implant and at 12-month follow-up (Group 1 vs. Group 2: pacing threshold 0.48 ± 0.05 V/0.24 ms vs. 0.56 ± 0.25 V/0.24 ms, P = 0.70; impedance 640 ± 148.83 Ohm vs. 583.43 ± 99.7 Ohm, P = 0.27; and R wave amplitude 10.33 ± 2.88 mV vs. 12.62 ± 5.31 mV, P = 0.40). A non-apical site of implant was achievable in the majority of cases (72.3%) without differences among groups (78.26% vs. 70%; P = 0.42).

Conclusion: Micra implant is an effective and safe procedure in patients still requiring a ventricular pacing after TLE, with similar electrical performance and outcome compared with naïve patients at long-term follow-up.
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http://dx.doi.org/10.1093/europace/euz160DOI Listing
August 2019