Publications by authors named "Giulio Zucchelli"

74 Publications

Safety of cryoballoon ablation for the treatment of atrial fibrillation: First European results from the cryo AF Global Registry.

Pacing Clin Electrophysiol 2021 May 4;44(5):883-894. Epub 2021 May 4.

Cardioangiologisches Centrum Bethanien, Frankfurt, Germany.

Background: Cryoballoon ablation for the treatment of patients with atrial fibrillation (AF) has been utilized in Europe for >15 years.

Objectives: Report patient and procedural characteristics that influence the safety of cryoablation for the treatment of AF.

Methods: Patients enrolled in the prospective, multicenter Cryo AF Global Registry were treated at 38 European centers. Freedom from a ≥30s episode of AF/atrial flutter (AFL)/atrial tachycardia (AT) at 12-months and serious complications were analyzed. Univariate and multivariable models identified baseline patient and procedural characteristics that predicted a procedure-related complication.

Results: Of the 1418 subjects who completed an index procedure, the cohort was 62 ± 11 years of age, 37.7% female, and 72.2% paroxysmal AF (PAF). The mean procedure, left atrial dwell, and fluoroscopy times were 81 ± 34, 54 ± 25, and 14 ± 13 min, respectively. Among the 766 patients with 12-month follow-up, freedom from a ≥30 s AF/AFL/AT recurrence was 83.3% (95% CI: 79.8%-86.3%) and 71.6% (95% CI: 64.6%-77.4%) in patients with PAF and persistent AF. The serious procedure- and device-related adverse event rates were 4.7% and 2.0%. No baseline patient characteristic independently predicted a procedure-related adverse event; however, prolonged procedure duration (OR = 1.01 [95% CI: 1.00-1.01]), use of general anesthesia (OR = 1.71 [95% CI: 1.01-2.92]), and delivery of a cavotricuspid isthmus line (OR = 3.04 [95% CI: 1.01-9.20]) were each independently associated with the occurrence of a serious procedural safety event (all p < .05).

Conclusions: Cryoballoon ablation is safe and effective in real-world use across a broad cohort of patients with AF.
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http://dx.doi.org/10.1111/pace.14237DOI Listing
May 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

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

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

Arrhythmogenic substrate detection in chronic ischaemic patients undergoing ventricular tachycardia ablation using multidetector cardiac computed tomography: compared evaluation with cardiac magnetic resonance.

Europace 2021 Jan;23(1):82-90

Heart Institute, Teknon Medical Center, C/Vilana, 12, 08022 Barcelona, Spain.

Aims: Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) permits characterizing ischaemic scars, detecting heterogeneous tissue channels (HTCs) which constitute the arrhythmogenic substrate (AS). Late gadolinium enhancement cardiac magnetic resonance also improves the arrhythmia-free survival when used to guide ventricular tachycardia (VT) substrate ablation. However, its availability may be limited. We sought to evaluate the performance of multidetector cardiac computed tomography (MDCT) imaging in identifying HTCs detected by LGE-CMR in ischaemic patients undergoing VT substrate ablation.

Methods And Results: Thirty ischaemic patients undergoing both LGE-CMR and MDCT before VT substrate ablation were included. Using a dedicated post-processing software, two blinded operators, assigned either to LGE-CMR or MDCT analysis, characterized the presence of CMR and computed tomography (CT) channels, respectively. Cardiac magnetic resonance channels were classified as endocardial (layers < 50%), epicardial (layers ≥ 50%), or transmural. Cardiac magnetic resonance- vs. CT-channel concordance was considered when showing the same orientation and American Heart Association (AHA) segment. Mean age was 69 ± 10 years; 90% were male. Mean left ventricular ejection fraction was 35 ± 10%. All patients had CMR channels (n = 76), whereas only 26/30 (86.7%) had CT channels (n = 91). Global sensitivity (Se) and positive predictive values for detecting CMR channels were 61.8% and 51.6%, respectively. MDCT performance improved in patients with epicardial CMR channels (Se 80.5%) and transmural scars (Se 72.2%). In 4/11 (36%) patients with subendocardial myocardial infarction (MI), MDCT was unable to identify the AS.

Conclusions: Compared to LGE-CMR, myocardial wall thickness assessment using MDCT fails to detect the presence of AS in 36% of patients with subendocardial MI, showing modest sensitivity identifying HTCs but a better performance in patients with transmural scars.
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http://dx.doi.org/10.1093/europace/euaa237DOI 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

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

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

Reproducibility of pulmonary vein isolation guided by the ablation index: 1-year outcome of the AIR registry.

J Cardiovasc Electrophysiol 2020 07 11;31(7):1694-1701. Epub 2020 May 11.

Clinica Montevergine, Mercogliano, Avellino, Italy.

Background: Ablation index (AI) is a new lesion quality marker that has been demonstrated to allow a high single-procedure arrhythmia-free survival in single-center studies. This prospective, multi-center study was designed to evaluate the reproducibility of pulmonary vein (PV) isolation guided by the AI.

Methods: A total of 490 consecutive patients with paroxysmal (80.4%) and persistent AF underwent first time PV isolation and were divided in four study groups according to operator's preference in choosing the ablation catheter (a contact force (ST) or contact force surround flow (STSF) catheter) and the AI setting (330-450 or 380-500 at anterior wall or posterior wall, respectively).

Results: At 12 months a high rate of freedom from AF recurrences was observed in patients with both paroxysmal and persistent AF (91% vs 83.3%; P = .039). There was no difference in the rate of AF recurrence among the four study groups (4.5% in group ST330-450, 12.2% in group ST 380-500, 14.9% in group STSF330-450, 9.4% in group STSF380-500; P = .083). Recurrence was also similar between patients treated with a ST (8%) or STSF catheter (12.1%; P = .2), and within patients targeting an AI settings of 330 to 450 (10.9%) or 380 to 500 (10.3%; P = .64). In patients with paroxysmal AF, there was no difference (P = .12) in the 1-year freedom from AF recurrence among 14 operators that performed ≥10 ablation procedure.

Conclusions: An ablation protocol respecting strict criteria for contiguity and quality lesion resulted in high rate of 1-year freedom from AF recurrence, irrespective of the ablation catheters, AI settings, and operator.
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http://dx.doi.org/10.1111/jce.14531DOI Listing
July 2020

Cardiac Magnetic Resonance-Guided Ventricular Tachycardia Substrate Ablation.

JACC Clin Electrophysiol 2020 04 26;6(4):436-447. Epub 2020 Feb 26.

Heart Institute, Teknon Medical Center, Barcelona, Spain; Clinic Cardiovascular Institute, Hospital Clínic, Barcelona, Spain. Electronic address:

Objectives: This study assessed the feasibility and potential benefit of performing ventricular tachycardia (VT) substrate ablation procedures guided by cardiac magnetic resonance (CMR)-derived pixel signal intensity (PSI) maps.

Background: CMR-aided VT ablation using PSI maps from late gadolinium enhancement-CMR (LGE-CMR), together with electroanatomical map (EAM) information, has been shown to improve outcomes of VT substrate ablation.

Methods: Eighty-four patients with scar-dependent monomorphic VT who underwent substrate ablation were included in the study. In the last 28 (33%) consecutive patients, the procedure was guided by CMR. Procedural data, as well as acute and follow-up outcomes, were compared between patients who underwent guided CMR and 2 control groups: 1) patients who had PSI maps were available but the EAM was acquired and used to select the ablation targets (CMR aided); and 2) patients with no CMR-derived PSI maps available (no CMR).

Results: Mean procedure duration was lower in CMR-guided substrate ablation compared with CMR-aided and no CMR (107 ± 59 min vs. 203 ± 68 min and 227 ± 52 min; p < 0.001 for both comparisons). CMR-guided ablation required less fluoroscopy time than CMR-aided ablation and no CMR (10 ± 4 min vs. 23 ± 11 min and 20 ± 9 min, respectively; p < 0.001 for both comparisons) and less radiofrequency time (15 ± 8 min vs. 20 ± 15 min and 26 ± 10 min; p = 0.16 and p < 0.001, respectively). After substrate ablation, VT inducibility was lower in CMR-guided ablation compared with CMR-aided ablation and no CMR (18% vs. 32% and 46%; p = 0.35 and p = 0.04, respectively), without significant differences in complications. After 12 months, VT recurrence was lower in those who underwent CMR-guided ablation compared with no CMR (log-rank: 0.019), with no differences with CMR-aided ablation.

Conclusions: CMR-guided VT ablation is feasible and safe, significantly reduces the procedural, fluoroscopy, and radiofrequency times, and is associated with a higher noninducibility rate and lower VT recurrence after substrate ablation.
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http://dx.doi.org/10.1016/j.jacep.2019.11.004DOI Listing
April 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

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

Ablation Index as a predictor of long-term efficacy in premature ventricular complex ablation: A regional target value analysis.

Heart Rhythm 2019 06 4;16(6):888-895. Epub 2019 Jan 4.

Heart Rhythm Center, Centro Cardiologico Monzino IRCCS, Milan, Italy; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.

Background: The effectiveness of radiofrequency catheter ablation (RFCA) in atrial tachyarrhythmias correlates with lesion transmurality. Ablation Index (AI) is an index that incorporates contact force, time, and radiofrequency power simultaneously and is able to predict lesion size and outcomes in RFCA of atrial fibrillation.

Objective: The purpose of this study was to assess whether AI could be an acute and long-term success predictor in RFCA of premature ventricular complexes (PVCs).

Methods: One hundred forty-five patients with idiopathic outflow tract PVCs undergoing RFCA were retrospectively enrolled. The maximum and maximum AI values were calculated for each ablation site. Acute and 6-month outcomes were analyzed. Patients were divided into 3 outcome subgroups-success, acute failure, and 6-month failure-and the maximum and mean AI values were compared.

Results: Acute and 6-month success rates were 95% and 77%, respectively. The maximum and mean AI values were statistically higher in the success group (median of the maximum AI 630 [IQR 561-742]; median of the mean AI 489 [IQR 411-560]) than in the acute failure group (median of the maximum AI 487 [IQR 445-583]; median of the mean AI 372 [IQR 332-434]; P < .0001 for both) and the 6-month failure group (median of the maximum AI 519 [IQR 476-568]; median of the mean AI 410 [IQR 368-472]; P < .0001 for both). Both maximum and mean AI values were confirmed to be statistically higher in the success group than in the failure/6-month failure group (P = .001 and P = .04, respectively) and right ventricular free wall (P = .007 and P = .01, respectively) PVC origin subgroups.

Conclusion: Our data support the concept that AI could be a long-term success predictor in RFCA of PVCs. However, further prospective studies are required to assess the feasibility of the AI-guided PVC ablation approach.
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http://dx.doi.org/10.1016/j.hrthm.2019.01.005DOI Listing
June 2019

Predictors of ventricular ablation's success: Viability, innervation, or mismatch?

J Nucl Cardiol 2021 Feb 2;28(1):175-183. Epub 2019 Jan 2.

Fondazione Toscana G. Monasterio, Via Moruzzi, 1, 56124, Pisa, Italy.

Aims: Sympathetic dys-innervation may play an important role in the development of post-ischemic ventricular arrhythmias (VA). Aim of this study was to prove that perfusion/innervation mismatch (PIM) evaluated by SPECT can identify areas of local abnormal ventricular activities (LAVA) on electroanatomic mapping (EAM).

Methods: Sixteen patients referred to post-ischemic VA catheter ablation underwent pre-procedural and 1-month post-ablation I-MIBG/Tc-tetrofosmin rest SPECT myocardial imaging. PIM was defined according to the segmental distributions of 99mTc-tetrofosmin and 123I-MIBG. A 17-segment LV analysis was used for either SPECT or LV EAM voltage map. All patients were followed up clinically for at least 1 year.

Results: Before ablation, the mean voltage in the PIM segments was higher than in the scarred ones but lower than in the normal regions. The presence of PIM in a specific LV zone was an independent predictor of LAVA. After ablation, PIM value was significantly reduced, mainly due to an increase in perfusion summed rest score, in particular in patients that were responders to ablation.

Conclusions: PIM may associate with VA substrate expressed by LAVA and might provide a novel guide for substrate ablation. A significant reduction of PIM could predict a positive clinical response to ablation.
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http://dx.doi.org/10.1007/s12350-018-01575-xDOI Listing
February 2021

Major cardiac and vascular complications after transvenous lead extraction: acute outcome and predictive factors from the ESC-EHRA ELECTRa (European Lead Extraction ConTRolled) registry.

Europace 2019 May;21(5):771-780

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

Aims: We aimed at describing outcomes and predictors of cardiac avulsion or tear (CA/T) with tamponade and vascular avulsion or tear (VA/T) after transvenous lead extraction (TLE) in the ESC-EHRA European Lead Extraction ConTRolled (ELECTRa) registry.

Methods And Results: A total of 3555 consecutive patients of whom 3510 underwent TLE at 73 centres in 19 European countries were enrolled. Among 58 patients (1.7%) with procedure-related major complications, 49 (84.5%) patients (30 CA/T and 19 VA/T) presented cardiovascular complications requiring pericardiocentesis, chest tube positioning and/or surgical repair. The mortality was 20% in patients with tamponade due to CA/T and 31.6% in patients with VA/T. Pericardiocentesis as first manoeuvre followed by rescue surgical repair was highly effective in case of CA/T (93.8%). At multivariate analysis, CA/T with tamponade was more common in RIATA lead extraction, female patients, leads with a mean dwelling time more than 10 years, and when ≥3 leads were extracted or multiple sheaths required. Occlusion or critical stenosis of superior venous access and the leads mean dwelling time more than 10 years were independent predictors for VA/T, while mechanical dilatation was an independent predictor of a lower incidence of this complication as compared to the use of powered sheaths.

Conclusions: In the ELECTRa registry, RIATA lead extraction and superior venous access occlusion/thrombosis are two new independent predictors for cardiac tamponade and major vascular complications, respectively. The use of mechanical sheaths seems to be associated with a lower incidence of VA/T. A strategy of pericardiocentesis followed by a rescue surgical approach seems to be reasonable in order to treat a CA/T with tamponade.
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http://dx.doi.org/10.1093/europace/euy300DOI Listing
May 2019

Leadless pacing in a patient with superior vena cava syndrome undergoing lead extraction and percutaneous angioplasty.

J Cardiol Cases 2018 Jun 30;17(6):212-214. Epub 2018 Mar 30.

Cardiac Thoracic and Vascular Department - AOUP, Santa Chiara University Hospital, Pisa, Italy.

Superior vena cava (SVC) syndrome is an uncommon but serious complication associated with chronic transvenous implanted leads. In the recent past, open-heart surgery combining lead extraction and epicardial implant was usually performed to reduce syndrome recurrences. We describe the case of a 78-year-old man successfully treated by percutaneous lead extraction associated with venous balloon angioplasty and reimplantation of leadless pacemaker. < Chronic vascular complications following lead implantation usually require surgical treatment, due to the need for subsequent epicardial implantation. Percutaneous lead extraction along with leadless pacing allowed effective non-surgical management of chronic complications of transvenous pacing.>.
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http://dx.doi.org/10.1016/j.jccase.2018.02.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6149588PMC
June 2018

Left ventricular reverse remodeling after transcatheter aortic valve implantation complicated by paroxysmal complete atrioventricular block.

J Cardiol Cases 2018 Jun 8;17(6):194-196. Epub 2018 Mar 8.

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

An 86-year-old man with unremarkable clinical history complaining of asthenia and dyspnea was diagnosed with low-flow low-gradient aortic stenosis [LFLG-AS; left ventricular ejection fraction (LVEF) 40% and transaortic mean gradient 37 mmHg, increasing to 52% and 55 mmHg after dobutamine infusion]. The patient underwent transcatheter aortic valve implantation (TAVI; Edwards CENTERA™ 29, Irvine, CA, USA). The procedure and the following hospital stay were free from complications, with no changes on electrocardiography (ECG). Six months later, few syncopal episodes occurred. No signs of orthostatic hypotension or neurologic disorders were present. Echocardiography showed normal functioning of the prosthetic valve and recovery of LV systolic function (LVEF 55%). Baseline ECG and 24-h Holter monitoring were unremarkable. An implantable loop recorder (ILR) was implanted to verify the occurrence of paroxysmal conduction disturbances. One month later, during a syncopal episode, ILR interrogation showed a complete atrioventricular (AV) block. Therefore, a dual chamber, single lead pacemaker was implanted. We are providing the first report of complete AV block occurring months after TAVI, possibly because of reverse LV remodeling following TAVI, with ensuing relative oversizing of the prosthetic valve. This possibility should be considered in patients with syncope not otherwise explained, and previous TAVI, especially in cases of LFLG-AS. < Complete atrioventricular block can occur even months after transcatheter aortic valve implantation (TAVI), possibly because of left ventricular reverse remodeling following valve replacement, with ensuing relative valve oversizing. This possibility should be considered in patients with syncope not otherwise explained, and previous TAVI, especially in cases of low flow low gradient aortic stenosis. Loop recorder implantation should be considered in this group of patients.>.
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http://dx.doi.org/10.1016/j.jccase.2018.01.010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6149591PMC
June 2018

Utility of risk scores to predict adverse events in cardiac lead extraction.

Expert Rev Cardiovasc Ther 2018 Oct 27;16(10):695-705. Epub 2018 Aug 27.

a Second Division of Cardiovascular Diseases, Cardiac and Thoracic Department, New Santa Chiara Hospital , University of Pisa , Pisa , Italy.

Introduction: Increasing device implantations, patient comorbidities, and longer life expectancy contribute to an increased need for lead extraction. Even if transvenous lead extraction (TLE) is a highly successful procedure, some serious procedural complications are reported. In order to identify those patients who are at higher risk, risk stratification scores were proposed. Areas covered: The major obstacles to lead extractions are represented by the body's response to the foreign implanted material and by the following development of fibrotic reaction between the lead and the vascular system. Several clinical factors and device features are associated with major complications and worse outcomes. Although different multiparametric scores predicting the safety and the efficacy of TLE procedures were reported, none of these scores were prospective evaluated. Expert commentary: A correct risk stratification is needed in order to refer complex patients to centers with proven experience and avoid futile procedures. Furthermore, the identification of high-risk patients allows to perform the extraction procedure in the operating room instead of electrophysiology lab. Albeit some risk scores able to predict adverse event in cardiac lead extraction were described, there are still several limitations to their use and reproducibility.
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http://dx.doi.org/10.1080/14779072.2018.1513325DOI Listing
October 2018

Feasibility and long-term effectiveness of a non-apical Micra pacemaker implantation in a referral centre for lead extraction.

Europace 2019 Jan;21(1):114-120

Cardiac Thoracic and Vascular Department, University Hospital of Pisa, Via Paradisa 2, Pisa, Italy.

Aims: To demonstrate the feasibility and long-term performances of a non-apical Micra pacemaker implantation.

Methods And Results: Fifty-two consecutive patients underwent Micra implantation, targeting a non-apical site of delivery when feasible. Each patient received a regular follow-up (mean 13 ± 9 months). The first 17 patients were also enrolled in the Micra transcatheter pacing system trial (Group 1); the remaining ones presented broader indications and included post-extraction subjects (Group 2). In 19 of 52 patients (Group 1: 6%, Group 2: 51%; P = 0.002) Micra was implanted because of high-risk characteristics that discouraged the implantation of a traditional pacemaker. In 31 of 52 patients (60%) Micra was implanted in a non-apical location, with a lower rate of single delivery compared with apical sites (48% vs. 81%, P = 0.035), but without any impact on electrical performance. Pacing threshold remained optimal in the majority of patients (94%), regardless of the site of implantation (apical vs. non-apical location: 0.50 vs. 0.52 V/0.24 ms; P = 0.856) and group membership, with only 6% of the subjects showing elevated values (mean 1.92 ± 0.92 V/0.24 ms) at the last follow-up. No device-related adverse events were registered.

Conclusion: Micra pacemaker implant is a safe and effective procedure even in a real life cohort of high-risk patients. A non-apical site of implantation is feasible in the majority of patients allowing stable electrical performance at long-term follow-up.
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http://dx.doi.org/10.1093/europace/euy116DOI Listing
January 2019

Role of cardiac electronic implantable device in the stratification and management of embolic risk of silent atrial fibrillation: are all atrial fibrillations created equal?

Expert Rev Cardiovasc Ther 2018 Mar 15;16(3):175-181. Epub 2018 Feb 15.

c Division of Cardiology, Cardiovascular and Thoracic Department , Santa Maria alle Scotte Hospital , Siena , Italy.

Introduction: Ischemic strokes may be associated with atrial fibrillation (AF). AF detection is critical in ischemic stroke survivors, often recommending a switch from antiplatelet therapy to oral anticoagulants for secondary prevention. Areas covered: Cardiac implantable electronic devices (CIED) with their long-term recording capability allows to document AF and to quantify the arrhythmia burden. Recent series in pacemaker and implantable cardioverter-defibrillator (ICD) recipients with no prior stroke showed that short episodes of AF increased stroke risk compared with those without AF recorded. Detection of AF by CIEDs represent a unique opportunity for promp prevention of embolic risk in silent AF. It will be attractive to identify AF before a stroke occurs. Expert commentary: The purpose of this article is to review the role of CIED to detect AF, to quantify the role of AF burden, and to guide primary and secondary stroke prevention.
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http://dx.doi.org/10.1080/14779072.2018.1438267DOI Listing
March 2018

Contiguity Between Ablation Lesions and Strict Catheter Stability Settings Assessed by VISITAG Module Improve Clinical Outcomes of Paroxysmal Atrial Fibrillation Ablation - Results From the VISITALY Study.

Circ J 2018 03 8;82(4):974-982. Epub 2018 Feb 8.

Cardiac Thoracic and Vascular Department - University Hospital of Pisa.

Background: Our aim was to evaluate the clinical outcome of paroxysmal atrial fibrillation (AF) ablation with contact force technology, using an automated lesion tagging system (VISITAG module) with strict criteria of catheter stability.Methods and Results:We enrolled 200 consecutive patients who underwent pulmonary vein isolation (PVI) in 11 centers and were followed up for 12 months. The stability setting was within 3 mm for ≥10 s and for ≥15 s in 47% and 53% of patients, respectively. A mean of 67.2±21.9 VISITAGs was acquired. Freedom from atrial tachyarrhythmias at follow-up was 77.5% (155/200), and the contiguity between lesions was associated with a higher chronic success rate (96% vs. 77.1%; log-rank P=0.036). Radiofrequency (RF), fluoroscopy times, and recurrence rates at the 12-month follow-up were significantly lower than in a comparison group of 80 patients without VISITAG module (42.7±14.5 vs. 50.9±23.6 min; P=0.032; 11.6±7.8 vs. 18.4±12.8 min; P=0.003 and 22.5% vs. 41.2%; P=0.02). Two major complications (1 cardiac tamponade and 1 minor stroke) were observed only in the control group.

Conclusions: Paroxysmal AF ablation with contact force technology and strict criteria of stability using the VISITAG module was a safe procedure, associated with an improvement in efficiency and a reduction of atrial tachyarrhythmia recurrence at the 12-month follow-up compared with manual annotation. Contiguity between lesions seemed to enhance effectiveness outcomes.
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http://dx.doi.org/10.1253/circj.CJ-17-0421DOI Listing
March 2018

Prevention of sudden cardiac death: from wearable to subcutaneous cardioverter defibrillator.

Minerva Cardioangiol 2018 Feb 10;66(1):83-99. Epub 2017 Jul 10.

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

The implantable cardioverter defibrillator (ICD) is today an indisputable evidence-based treatment for cardiac sudden death both in primary and secondary prevention. However many clinical conditions that would represent an indication to ICD implantation, according to guidelines, may be potentially reversible or may be accompanied by temporary contraindications to the implant. Moreover transvenous cardioverter defibrillator implantation still carries a not negligible risk of complications both acutely and at follow-up. The Wearable Cardioverter Defibrillator and the Subcutaneous Defibrillator are two recently developed technologies that can potentially overcome the aforementioned limitations of traditional transvenous ICDs. This review will discuss the main aspects of these 2 technologies, the data coming from clinical experiences and future perspectives.
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http://dx.doi.org/10.23736/S0026-4725.17.04468-1DOI Listing
February 2018

Leadless technology: a new paradigm for cardiac pacing?

Minerva Cardioangiol 2018 Feb 10;66(1):113-123. Epub 2017 Jul 10.

Cardiac Thoracic and Vascular Department, AOUP, Santa Chiara University Hospital, Pisa, Italy.

Leadless pacemaker (LP) technology was recently developed and introduced for clinical purpose as an alternative to traditional systems in order to reduce leads and pocket-related complications. Currently, two self-contained right ventricular pacemakers implanted by using a femoral percutaneous approach have been developed and initial results seem promising. Although the clinical use is still limited to the right ventricular pacing, the LP currently represents a valid and alternative solution in several settings, when the standard pacemaker cannot be used or its use is associated with higher risk of complications. Implementation of particular pacing algorithms in the near future will allow for a VDD pacing mode with only a single ventricular component, whereas the next evolution of technology will lead to develop multicomponent, communicating leadless systems capable to perform a dual-chamber pacing or even a cardiac resynchronization. The management after battery depletion is still controversial and experience on retrievability is anecdotic. Long term data from registry are necessary to reinforce the reliability of these systems in the real life and randomized trials comparing LPs with traditional pacemaker will be essential to better understand if the LP can become a new paradigm in cardiac pacing.
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http://dx.doi.org/10.23736/S0026-4725.17.04465-6DOI Listing
February 2018

Overcoming the current issues surrounding device leads: reducing the complications during extraction.

Expert Rev Med Devices 2017 Jun;14(6):469-480

a Second Division of Cardiovascular Diseases, Cardiac and Thoracic Department , New Santa Chiara Hospital, University of Pisa , Pisa , Italy.

Introduction: The implantation rate of cardiac implantable electronic devices has consistently increased in the last 20 years, as have the related complication rates. The most relevant issue is the removal of pacing and implantable cardioverter defibrillator (ICD) leads, which a few months after implantation tend to develop intravascular fibrosis, often making extraction a challenging and risky procedure. Areas covered: The transvenous lead extraction (TLE) scenario is constantly evolving. TLE is a key procedure in lead management strategies. Many efforts have been made to develop new TLE approaches and techniques allowing a safe and effective procedure for patients. The increasing rate of cardiac implantable electronic device (CIED) implantations and of CIED related complications highlight the importance of TLE. Lead related- and patient-related factors may change the future of extractions. We review the current status of TLE, focusing on the strategies available to perform the optimal procedure in the right patient and reducing procedure related complications. Expert commentary: Understanding the importance of an accurate TLE risk stratification is mandatory to optimize the procedural risk-to-benefits ratio. The use of adequate tools, techniques and approaches, and appropriate training are cornerstones for the achievement of safer procedures.
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http://dx.doi.org/10.1080/17434440.2017.1332990DOI Listing
June 2017

Relation Between Clinical Best Practices and 6-Month Outcomes After Transcatheter Aortic Valve Implantation With CoreValve (from the ADVANCE II Study).

Am J Cardiol 2017 Jan 30;119(1):84-90. Epub 2016 Sep 30.

Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.

Best practices for transcatheter aortic valve implantation with CoreValve include patient screening and valve size selection using multislice computed tomography, adherence to manufacturer recommendations for oversizing, control of implant depth to 6 mm or less, and management of conduction disturbances according to international guidelines. The ADVANCE II study implemented these strategies and demonstrated their relation to clinical outcomes. From October 2011 to April 2013, 200 patients with severe aortic stenosis were enrolled, and 194 were implanted. All imaging and electrocardiographic data were analyzed by an independent core laboratory, and adverse events were adjudicated to valve academic research consortium-2 definitions. The mean age was 80.2 ± 6.7 years and the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 7.2 ± 6.8% for the enrolled patients. At 6 months, all-cause mortality was 9.2%, stroke was 2.6%, and permanent pacemaker implantation was 19.2% for class I and II indications. In patients with implant depth ≤6 mm, both mortality and permanent pacemaker implantation were lower than in patients with depth >6 mm (2.5% vs 14.5%, p <0.01 and 18.1% vs 31.7%, p = 0.03, respectively). The rate of moderate and severe paravalvular leak was 9.8% at 7 days after transcatheter aortic valve implantation, decreasing to 4.3% at 6 months (p = 0.02). Valves were significantly more oversized in patients with mild or less paravalvular leak at day 7 compared with those with moderate or severe (15.8 ± 8.0% vs 11.8 ± 4.9%, p = 0.01). In conclusion, findings from the ADVANCE II study reinforce that adherence to best clinical practices improves patient outcomes.
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http://dx.doi.org/10.1016/j.amjcard.2016.09.016DOI Listing
January 2017