Arrhythmic risk profile in mitral valve prolapse: A systematic review and metanalysis of 1715 patients.

INTRODUCTION: Mitral valve prolapse (MVP) is a common clinical condition in the general population. A subgroup of patients with MVP may experience ventricular arrhythmias and sudden cardiac death ("arrhythmic mitral valve prolapse" [AMVP]) but how to stratify arrhythmic risk is still unclear. Our meta-analysis aims to identify predictive factors for arrhythmic risk in patients with MVP. METHODS: We systematically searched Medline, Cochrane, Journals@Ovid, Scopus electronic databases for studies published up to December 28, 2022 and comparing AMVP and nonarrhythmic mitral valve prolapse (NAMVP) for what concerns history, electrocardiographic, echocardiographic and cardiac magnetic resonance features. The effect size was estimated using a random-effect model as odds ratio (OR) and mean difference (MD). RESULTS: A total of 10 studies enrolling 1715 patients were included. Late gadolinium enhancement (LGE) (OR: 16.67; p = .005), T-wave inversion (TWI) (OR: 2.63; p < .0001), bileaflet MVP (OR: 1.92; p < .0001) and mitral anulus disjunction (MAD) (OR: 2.60; p < .0001) were more represented among patients with AMVP than in NAMVP. Patients with AMVP were shown to have longer anterior mitral leaflet (AML) (MD: 2.63 mm; p < .0001), posterior mitral leaflet (MD: 2.96 mm; p < .0001), thicker AML (MD: 0.49 mm; p < .0001), longer MAD length (MD: 1.24 mm; p < .0001) and higher amount of LGE (MD: 1.41%; p < .0001) than NAMVP. AMVP showed increased mechanical dispersion (MD: 8.04 ms; 95% confidence interval: 5.13-10.96; p < .0001) compared with NAMVP. CONCLUSIONS: Our meta-analysis proved that LGE, TWI, bileaflet MVP, and MAD are predictive factors for arrhythmic risk in MVP patients.

Baseline left atrial low-voltage area predicts recurrence after pulmonary vein isolation: WAVE-MAP AF results.

AIMS: Electro-anatomical mapping may be critical to identify atrial fibrillation (AF) subjects who require substrate modification beyond pulmonary vein isolation (PVI). The objective was to determine correlations between pre-ablation mapping characteristics and 12-month outcomes after a single PVI-only catheter ablation of AF. METHODS AND RESULTS: This study enrolled paroxysmal AF (PAF), early persistent AF (PsAF; 7 days-3 months), and non-early PsAF (>3-12 months) subjects undergoing de novo PVI-only radiofrequency catheter ablation. Sinus rhythm (SR) and AF voltage maps were created with the Advisor HD Grid™ Mapping Catheter, Sensor Enabled™ for each subject, and the presence of low-voltage area (LVA) (low-voltage cutoffs: 0.1-1.5 mV) was investigated. Follow-up visits were at 3, 6, and 12 months, with a 24-h Holter monitor at 12 months. A Cox proportional hazards model identified associations between mapping data and 12-month recurrence after a single PVI procedure. The study enrolled 300 subjects (113 PAF, 86 early PsAF, and 101 non-early PsAF) at 18 centres. At 12 months, 75.5% of subjects were free from AF/atrial flutter (AFL)/atrial tachycardia (AT) recurrence. Univariate analysis found that arrhythmia recurrence did not correlate with AF diagnosis, but LVA was significantly correlated. Low-voltage area (<0.5 mV) >28% of the left atrium in SR [hazard ratio (HR): 4.82, 95% confidence interval (CI): 2.08-11.18; P = 0.0003] and >72% in AF (HR: 5.66, 95% CI: 2.34-13.69; P = 0.0001) was associated with a higher risk of AF/AFL/AT recurrence at 12 months. CONCLUSION: Larger extension of LVA was associated with an increased risk of arrhythmia recurrence. These subjects may benefit from substrate modification beyond PVI.

Targeted ablation of residual pulmonary vein potentials in atrial fibrillation ablation through ultra-high-density mapping: Insights from the CHARISMA registry.

INTRODUCTION: Low-voltage activity beyond pulmonary veins (PVs) may contribute to the failure of ablation of atrial fibrillation (AF) in the long term. We aimed to assess the presence of gaps (PVG) and residual potential (residual antral potential [RAP]) within the antral scar by means of an ultra-high-density mapping (UHDM) system. METHODS: We studied consecutive patients from the CHARISMA registry who were undergoing AF ablation and had complete characterization of residual PV antral activity. The Lumipoint™ (Boston Scientific) map-analysis tool was used sequentially on each PV component. The ablation endpoint was PV isolation (PVI) and electrical quiescence in the antral region. RESULTS: Fifty-eight cases of AF ablation were analyzed. A total of 86 PVGs in 34 (58.6%) patients and 44 RAPs in 34 patients (58.6%) were found. In 16 (27.6%) cases, we found at least one RAP in patients with complete absence of PV conduction. RAPs showed a lower mean voltage than PVG (0.3 ± 0.2 mV vs. 0.7 ± 0.5 mV, p < .0001), whereas the mean number of electrogram peaks was higher (8.4 ± 1.4 vs. 3.2 ± 1.5, p < .0001). The percentage of patients in whom RAPs were detected through Lumipoint™ was higher than through propagation map analysis (58.6% vs. 36.2%, p = .025). Acute procedural success was 100%, with all PVs successfully isolated and RAPs completely abolished in all study patients. During a mean follow-up of 453 ± 133 days, 6 patients (10.3%) suffered an AF/AT recurrence. CONCLUSION: Local vulnerabilities in antral lesion sets were easily discernible by means of the UHDM system in both de novo and redo patients when no PV conduction was present.

Minimal fluoroscopy approach for right-sided supraventricular tachycardia ablation with a novel ablation technology: Insights from the multicenter CHARISMA clinical registry.

BACKGROUND: No data exist on the ability of the novel Rhythmia 3-D mapping system to minimize fluoroscopy exposure during transcatheter ablation of arrhythmias. We report data on the feasibility and safety of a minimal fluoroscopic approach using this system in supraventricular tachycardia (SVT) procedures. METHODS: Consecutive patients were enrolled in the CHARISMA registry at 12 centers. All right-sided procedures performed with the Rhythmia mapping system were analyzed. The acquired electroanatomic information was used to reconstruct 3-D cardiac geometry; fluoroscopic confirmation was used whenever deemed necessary. RESULTS: Three hundred twenty-five patients (mean age = 56 ± 17 years, 57% male) were included: 152 atrioventricular nodal reentrant tachycardia, 116 atrial flutter, 41 and 16 right-sided accessory pathway and atrial tachycardia, respectively. Overall, 27 481 s of fluoroscopy were used (84.6 ± 224 s per procedure, equivalent effective dose = 1.1 ± 3.7 mSv per patient). One hundred ninety-two procedures (59.1%) were completed without the use of fluoroscopy (zero fluoroscopy, ZF). In multivariate analysis, the presence of a fellow in training (OR = 0.15, 95% CI: 0.05-0.46; p = .0008), radiofrequency application (0.99, 0.99-1.00; p = .0002), and mapping times (0.99, 0.99-1.00; p = .042) were all inversely associated with ZF approach. Acute procedural success was achieved in 97.8% of the cases (98.4 vs. 97% in the ZF vs. non-ZF group; p = .4503). During a mean of 290.7 ± 169.6 days follow-up, no major adverse events were reported, and recurrence of the primary arrhythmia was 2.5% (2.1 vs. 3% in the ZF vs. non-ZF group; p = .7206). CONCLUSIONS: The Rhythmia mapping system permits transcatheter ablation of right-sided SVT with minimal fluoroscopy exposure. Even more, in most cases, the system enables a ZF approach, without affecting safety and efficacy.

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

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 123I-MIBG/99mTc-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.

Standard versus strict stability criteria in radiofrequency paroxysmal atrial fibrillation ablation using ablation index.

PURPOSE: To compare the outcome of paroxysmal atrial fibrillation (AF) ablation via pulmonary vein isolation using Ablation Index (AI) with strict or standard stability criteria. METHODS: We enrolled 130 consecutive naive patients affected by paroxysmal AF who underwent PVI at two high-volume centers. AI target was ≥380 at the posterior wall and ≥500 at the anterior wall. Strict versus standard stability criteria were set for Group 1 (65 patients) and Group 2 (65 patients), respectively. We compared those strategies with a historical cohort of 72 consecutive patients treated at same centers in the VISITALY study, using average force ≥10 g and strict stability criteria as target parameters. Interlesion distance target was <6 mm. Recurrence was defined as any AF, atrial tachycardia (AT) or atrial flutter (AFL) during the 12 months after ablation, excluding a 90-days blanking period. RESULTS: Procedure duration (224.05 ± 47.21 vs. 175.61 ± 51.29 min; p < .001), fluoroscopy time (11.85 ± 4.38 vs. 10.46 ± 6.49 min; p = .019) and pericardial effusion rate (9.23% vs. 0%; p = .01) were higher in Group 1 than in Group 2. Freedom from AF/AT/AFL at 12 months was not significantly different (Group 1: 86.15%; Group 2: 90.77%; p = .42). Compared to VISITALY study, there were not significant differences in terms of recurrences. CONCLUSION: A strategy of PVI using AI with standard stability criteria performed the best in terms of procedure efficiency and safety. Twelve-months arrhythmia-free survival rate was comparable with other strategies pursuing an interlesion distance target <6 mm, regardless of the use of AI.

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.

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.

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

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.

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

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.

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

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.

Impact of anticoagulation therapy on outcomes in patients with cardiac implantable resynchronization devices undergoing transvenous lead extraction: A substudy of the ESC-EHRA EORP ELECTRa (European Lead Extraction ConTRolled) Registry.

INTRODUCTION: Little data are available on anticoagulation (AC) management in patients with cardiac resynchronization (CRT) devices who undergo transvenous lead extraction (TLE) procedure. We investigated the impact of AC on periprocedural complications in CRT patients undergoing TLE, enrolled in the ESC-EHRA European Lead Extraction ConTrolled (ELECTRa) registry. METHODS AND RESULTS: All CRT patients treated with TLE enrolled in the registry were considered. Perioperative AC management was left to the discretion of the Center. Major and minor intraprocedural and postprocedural complications were compared between patients without AC (Gp1) and patients with AC (Gp2). Regression analyses were performed to identify predictors of complications for Gp2. Out of 734 CRT pts, 328 (44.7%) were under AC (Gp2). Patients from Gp2 presented lower LVEF (Gp2 32.5 ± 10.9 vs Gp1 34.5 ± 11.9%; P = 0.03), more advanced heart failure disease (NYHA III/IV: Gp2 42.0 vs Gp1 31.5%; P = 0.02), and renal impairment (Gp2 39.0 vs Gp1 24.3%; P < 0.001). Perioperative regimens included AC interruption (Gp2A: n = 169, 51.5%), "bridging" (Gp2B: n = 135, 41.2%), or continued AC (Gp2C: n = 24, 7.3%). TLE complete success rates (98% in both groups) and major complication rates were comparable for both groups; minor bleeding events were more frequent in Gp2 (5.5%) compared to Gp1 (2.5%; P = 0.051). No independent predictors were identified for Gp2, but minor complications were associated with "bridging" approach (Gp2B: 16 events vs Gp2A/C: 9 events; P = 0.020). CONCLUSION: CRT patients treated with TLE under AC were more compromised but did not present more major complications compared to patients without AC. More minor complications were associated with "bridging" AC regimen.

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

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.

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

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.

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

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.

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

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.

Near zerO fluoroscopic exPosure during catheter ablAtion of supRavenTricular arrhYthmias: the NO-PARTY multicentre randomized trial.

AIMS: Aim of this study was to compare a minimally fluoroscopic radiofrequency catheter ablation with conventional fluoroscopy-guided ablation for supraventricular tachycardias (SVTs) in terms of ionizing radiation exposure for patient and operator and to estimate patients' lifetime attributable risks associated with such exposure. METHODS AND RESULTS: We performed a prospective, multicentre, randomized controlled trial in six electrophysiology (EP) laboratories in Italy. A total of 262 patients undergoing EP studies for SVT were randomized to perform a minimally fluoroscopic approach (MFA) procedure with the EnSiteTMNavXTM navigation system or a conventional approach (ConvA) procedure. The MFA was associated with a significant reduction in patients' radiation dose (0 mSv, iqr 0-0.08 vs. 8.87 mSv, iqr 3.67-22.01; P < 0.00001), total fluoroscopy time (0 s, iqr 0-12 vs. 859 s, iqr 545-1346; P < 0.00001), and operator radiation dose (1.55 vs. 25.33 µS per procedure; P < 0.001). In the MFA group, X-ray was not used at all in 72% (96/134) of cases. The acute success and complication rates were not different between the two groups (P = ns). The reduction in patients' exposure shows a 96% reduction in the estimated risks of cancer incidence and mortality and an important reduction in estimated years of life lost and years of life affected. Based on economic considerations, the benefits of MFA for patients and professionals are likely to justify its additional costs. CONCLUSION: This is the first multicentre randomized trial showing that a MFA in the ablation of SVTs dramatically reduces patients' exposure, risks of cancer incidence and mortality, and years of life affected and lost, keeping safety and efficacy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01132274.

Management of antithrombotic therapy in patients undergoing electrophysiological device surgery.

The aim of this review is to formulate practical recommendations for the management of antithrombotic therapy in patients undergoing cardiac implantable electronic device (CIED) surgery by providing indications for a systematic approach to the problem integrating general technical considerations with patient-specific elements based on a careful evaluation of the balance between haemorrhagic and thromboembolic risk. Hundreds of thousands patients undergo implantation or replacement of CIEDs annually in Europe, and up to 50% of these subjects receive antiplatelet agents or oral anticoagulants. The rate of CIED-related complications, mainly infective, has also significantly increased so that transvenous lead extraction procedures are, consequently, often required. Cardiac implantable electronic device surgery is peculiar and portends specific intrinsic risks of developing potentially fatal haemorrhagic complications; on the other hand, the periprocedural suspension of antithrombotic therapy in patients with high thromboembolic risk cardiac conditions may have catastrophic consequences. Accordingly, the management of the candidate to CIED surgery receiving concomitant antithrombotic therapy is a topic of great clinical relevance yet controversial and only partially, if at all, adequately addressed in evidence-based current guidelines. In spite of the fact that in many procedures it seems reasonably safe to proceed with aspirin only or without interruption of anticoagulants, restricting to selected cases the use of bridging therapy with parenteral heparins, there are lots of variables that may make the therapeutic choices challenging. The decision-making process applied in this document relies on the development of a stratification of the procedural haemorrhagic risk and of the risk deriving from the suspension of antiplatelet or anticoagulant therapy combined to generate different clinical scenarios with specific indications for optimal management of periprocedural antithrombotic therapy.

Subcutaneous implantable cardiac defibrillators: indications and limitations.

The implantable cardioverter defibrillator is today an indisputable evidence-based treatment for cardiac sudden death both in primary and secondary prevention. However, trans-venous cardioverter defibrillator implantation still carries a not negligible risk of complications both acutely and during follow-up. Trans-venous endocardial lead is the weak link of implantable cardioverter defibrillator (ICD) technology being the source of most mechanical complications on vessels and heart structures and exposed to infection, malfunction and recalls. A totally subcutaneous defibrillation lead has recently been introduced in clinical practice. With the subcutaneous pulse generator forms a defibrillation system that leaves the vessels and the heart completely "untouched." Subcutaneous ICD has proven to be safe and effective in many clinical trials. Patients without pacing indications and at higher risk of complications from trans-venous lead implantation represent the perfect candidates to S-ICD technology. However, with technical improvement, it is reasonable to expect a further expansion of indications.

Safety and efficacy of internal transjugular approach for transvenous extraction of implantable cardioverter defibrillator leads.

AIMS: We report our 15 years experience of a mechanical single-sheath technique with a multiple venous entry-site approach. We evaluated the effectiveness and safety of this technique in implantable defibrillator (ICD) lead extraction and investigated the potential association between clinical and lead-related factors and procedural complexity. METHODS AND RESULTS: The proposed technique consists of an initial attempt at manual traction, followed by mechanical dilatation performed through the venous entry-site and, if necessary, by crossover to the internal transjugular approach. The study cohort comprised 545 consecutive patients referred to our institution for transvenous lead extraction from January 1997 to December 2012. Initial manual traction resulted in the effective removal of 6% of leads. Mechanical dilatation increased the success rate to 89% when performed through the venous entry-site, and to 99% when subsequently attempted via the internal jugular vein. No major complications were associated with lead extraction. Dwell-time, a passive fixation mechanism and dual-coil lead design were independently associated with the need for mechanical dilatation. However, dwell-time was the only variable associated with crossover to the internal transjugular approach. Specifically, a dwell-time of 20 months best predicted the need for venous entry-site mechanical dilatation, while a value of 55 months predicted crossover to the internal transjugular approach. CONCLUSION: Mechanical transvenous extraction of ICD leads is a complex but safe and effective procedure. A longer lead dwell-time is associated with the need for mechanical dilatation and for crossover to the internal transjugular approach; this should be considered when planning the removal procedure. Moreover, passive lead fixation and dual-coil lead design predict a more challenging extraction procedure.