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3.
Heart Rhythm ; 2024 Feb 23.
Article in English | MEDLINE | ID: mdl-38403236

ABSTRACT

BACKGROUND: Epicardial access is often crucial for successful ventricular tachycardia (VT) ablation, but it is often burdened by significant procedural risk. Intentional coronary vein exit and intrapericardial CO2 insufflation (EpiCO2) can facilitate subxiphoid pericardial access. OBJECTIVE: This prospective study aimed to assess procedural feasibility, safety, and impact of the introduction of intrapericardial CO2 insufflation for epicardial access in a referral center for VT ablation. METHODS: All consecutive patients treated with epicardial VT ablation between November 2022 and January 2024 with the EpiCO2 technique at Pisa University Hospital were prospectively enrolled and compared in terms of feasibility, efficiency, and safety with a local retrospective cohort of patients treated with subxiphoid dry puncture between July 2018 and October 2022. RESULTS: Twenty-two consecutive patients (90.9% male; mean age, 54.3 years) underwent VT ablation with EpiCO2 during the study period. Epicardial access was achieved in all patients; median time from coronary sinus (CS) cannulation to epicardial access was 33 minutes. Intentional vein exit was successful in all cases, whereas CO2 insufflation was not feasible in 1 patient. There were no major complications and no significant bleeding. Since EpiCO2 introduction, epicardial approach utilization increased from 17.8% to 40% of all VT procedures. Comparison with 20 standard dry approach epicardial ablations showed no significant differences in terms of total procedural duration (322.5 [interquartile range, 296.75-363.75] minutes vs 359 [interquartile range, 323-409] minutes; P = .08). CONCLUSION: In our single-center experience, EpiCO2 was feasible and safe and led to significant increase in procedural volume without affecting total procedural time compared with standard dry puncture.

4.
Heliyon ; 10(3): e25404, 2024 Feb 15.
Article in English | MEDLINE | ID: mdl-38333823

ABSTRACT

Artificial Intelligence (AI) applications and Machine Learning (ML) methods have gained much attention in recent years for their ability to automatically detect patterns in data without being explicitly taught rules. Specific features characterise the ECGs of patients with Brugada Syndrome (BrS); however, there is still ambiguity regarding the correct diagnosis of BrS and its differentiation from other pathologies. This work presents an application of Echo State Networks (ESN) in the Recurrent Neural Networks (RNN) class for diagnosing BrS from the ECG time series. 12-lead ECGs were obtained from patients with a definite clinical diagnosis of spontaneous BrS Type 1 pattern (Group A), patients who underwent provocative pharmacological testing to induce BrS type 1 pattern, which resulted in positive (Group B) or negative (Group C), and control subjects (Group D). One extracted beat in the V2 lead was used as input, and the dataset was used to train and evaluate the ESN model using a double cross-validation approach. ESN performance was compared with that of 4 cardiologists trained in electrophysiology. The model performance was assessed in the dataset, with a correct global diagnosis observed in 91.5 % of cases compared to clinicians (88.0 %). High specificity (94.5 %), sensitivity (87.0 %) and AUC (94.7 %) for BrS recognition by ESN were observed in Groups A + B vs. C + D. Our results show that this ML model can discriminate Type 1 BrS ECGs with high accuracy comparable to expert clinicians. Future availability of larger datasets may improve the model performance and increase the potential of the ESN as a clinical support system tool for daily clinical practice.

5.
Ann Cardiothorac Surg ; 13(1): 31-43, 2024 Jan 30.
Article in English | MEDLINE | ID: mdl-38380136

ABSTRACT

Atrial fibrillation (AF) is the most common arrhythmia in the adult population and catheter ablation has emerged as an important rhythm-control strategy and is the most common cardiac ablation procedure performed worldwide. The antiarrhythmic drugs have demonstrated moderate efficacy in long-term maintenance of sinus rhythm; moreover, they are often not tolerated and are associated with adverse events. Catheter ablation has proven to be effective in treating AF, although long-term outcomes have been significantly less favorable in persistent AF than in paroxysmal. The current guidelines recommend catheter ablation as class I indication for patients whom antiarrhythmic drugs have failed or are not tolerated, and as first-line rhythm-control therapy in selected patients with symptomatic AF. Advances in technology and innovative ablation protocols resulted in a remarkable improvement of the efficacy outcomes after pulmonary vein isolation. This review seeks to provide an updated report of the current practices and approaches, and to describe the latest advances in technology that aim to improve procedural safety, efficacy and to reduce procedural requirements in terms of duration and fluoroscopy exposure.

8.
J Cardiovasc Electrophysiol ; 35(2): 290-300, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38098308

ABSTRACT

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.


Subject(s)
Leukemia, Myeloid, Acute , Mitral Valve Prolapse , Humans , Mitral Valve Prolapse/complications , Mitral Valve Prolapse/diagnostic imaging , Contrast Media , Gadolinium , Mitral Valve/diagnostic imaging , Arrhythmias, Cardiac/diagnosis , Arrhythmias, Cardiac/etiology , Arrhythmias, Cardiac/pathology , Leukemia, Myeloid, Acute/pathology
9.
Heart Rhythm O2 ; 4(10): 625-631, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37936665

ABSTRACT

Background: Existing data on the impact of sex differences on transvenous lead extraction (TLE) outcomes in cardiac device patients are limited. Objective: The purpose of this study was to evaluate the safety and efficacy of mechanical TLE in female patients. Methods: A retrospective evaluation was performed on 3051 TLE patients (group 1: female; group 2: male) from a single tertiary referral center. All individuals received treatment using single sheath mechanical dilation and various venous approaches as required. Results: Our analysis included 3051 patients (group 1: 750; group 2: 2301), with a total of 5515 leads handled with removal. Female patients were younger, had a higher left ventricular ejection fraction, and lower prevalences of coronary artery disease and diabetes mellitus. Infection was more common in male patients, whereas lead malfunction or abandonment were more frequent in female patients. Radiologic success was lower in female patients (95.8% vs 97.5%; P = .003), but there was no significant difference in clinical success between groups (97.2% vs 97.5%; P = .872). However, major complications (1.33% vs 0.60%; P <.001) and procedural mortality (0.4% vs 0.1%; P <.001) were higher in females compared to male patients. After multivariate analysis, female sex emerged as the only predictor of major complications, including deaths (odds ratio 3.96; 95% confidence interval 1.39-11.24). Conclusion: TLE using unpowered simple mechanical sheaths in female patients is safe and effective, but is associated with lower radiologic success and higher complication rates and mortality than in males. This finding underscores the importance of recognizing sex differences in TLE outcomes.

11.
J Clin Med ; 12(15)2023 Jul 28.
Article in English | MEDLINE | ID: mdl-37568387

ABSTRACT

High-power short-duration (HPSD) ablation is an increasingly used ablation strategy for pulmonary vein isolation (PVI) procedures, but Lesion Index (LSI)-guided HPSD radiofrequency (RF) applications have not been described in this clinical setting. We evaluated the procedural efficiency and safety of an LSI-guided HPSD strategy for atrial fibrillation (AF) ablation. Paroxysmal and persistent AF patients scheduled for AF ablation were prospectively enrolled and divided into two groups, according to the ablation power used (≥45 W for the LSI-HP Group and ≤40 W for the LSI-LP group). All patients underwent only PVI LSI-guided ablation (5.5 to 6 anteriorly; 5 to 5.5 superiorly, 4.5 to 5 posteriorly) with a point-by-point strategy and an inter-lesion distance <6 mm. Forty-six patients with AF (25 in the LSI-HP Group vs 21 in the LSI-LP Group)-59% paroxysmal, 78% male, with low-intermediate CHA2DS2-Vasc scores (2 [1-3]), a preserved ejection fraction (65 ± 6%) and a mean left atrial index volume of 39 ± 13 mL/m2 were prospectively enrolled. Baseline clinical characteristics were comparable between groups. PVI was successful in all patients. The RF time (29 (23-37) vs. 49 (41-53) min, p < 0.001), total procedure time (131 (126-145) vs. 155 (139-203) min, p = 0.007) and fluoroscopy time (12 (10-18) vs. 21 (16-26) min, p = 0.001) were significantly lower in the LSI-HP Group. No complications or steam pops were seen in either group. LSI-HP AF ablation significantly improved procedural efficiency-reducing ablation time, total procedural duration, and fluoroscopy use, while maintaining a comparable safety profile to lower-power procedures.

12.
Antibiotics (Basel) ; 12(6)2023 Jun 02.
Article in English | MEDLINE | ID: mdl-37370320

ABSTRACT

(1) Background: Infections are among the most frequent and life-threatening complications of cardiovascular implantable electronic device (CIED) implantation. The aim of this study is to compare the outcome and safety of a single-procedure device extraction and contralateral implantation versus the standard-of-care (SoC) two-stage replacement for infected CIEDs. (2) Methods: We retrospectively included 66 patients with CIED infections who were treated at two Italian hospitals. Of the 66 patients enrolled in the study, 27 underwent a single procedure, whereas 39 received SoC treatment. All patients were followed up for 12 months after the procedure. (3) Results: Considering those lost to follow-up, there were no differences in the mortality rates between the two cohorts, with survival rates of 81.5% in the single-procedure group and 84.6% in the SoC group (p = 0.075). (4) Conclusions: Single-procedure reimplantation associated with an active antibiofilm therapy may be a feasible and effective therapeutic option in CIED-dependent and frail patients. Further studies are warranted to define the best treatment regimen and strategies to select patients suitable for the single-procedure reimplantation.

13.
Europace ; 25(6)2023 06 02.
Article in English | MEDLINE | ID: mdl-37350404

ABSTRACT

AIMS: Subcutaneous implantable cardioverter-defibrillator (S-ICD) therapy is expanding rapidly. However, there are few data on the S-ICD extraction procedure and subsequent patient management. The aim of this analysis was to describe the procedure, management, and outcome of S-ICD extractions in clinical practice. METHODS AND RESULTS: We enrolled consecutive patients who required complete S-ICD extraction at 66 Italian centres. From 2013 to 2022, 2718 patients undergoing de novo implantation of an S-ICD were enrolled. Of these, 71 required complete S-ICD system extraction (17 owing to infection). The S-ICD system was successfully extracted in all patients, and no complications were reported; the median procedure duration was 40 (25th-75th percentile: 20-55) min. Simple manual traction was sufficient to remove the lead in 59 (84%) patients, in whom lead-dwelling time was shorter [20 (9-32) months vs. 30 (22-41) months; P = 0.032]. Hospitalization time was short in the case of both non-infectious [2 (1-2) days] and infectious indications [3 (1-6) days]. In the case of infection, no patients required post-extraction intravenous antibiotics, the median duration of any antibiotic therapy was 10 (10-14) days, and the re-implantation was performed during the same procedure in 29% of cases. No complications arose over a median of 21 months. CONCLUSION: The S-ICD extraction was safe and easy to perform, with no complications. Simple traction of the lead was successful in most patients, but specific tools could be needed for systems implanted for a longer time. The peri- and post-procedural management of S-ICD extraction was free from complications and not burdensome for patients and healthcare system. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov/Identifier: NCT02275637.


Subject(s)
Defibrillators, Implantable , Humans , Administration, Intravenous , Anti-Bacterial Agents , Hospitalization , Treatment Outcome
14.
J Clin Med ; 12(6)2023 Mar 20.
Article in English | MEDLINE | ID: mdl-36983388

ABSTRACT

INTRODUCTION: Transcatheter atrial fibrillation (AF) ablation is still carried out with continuous invasive radial arterial blood pressure (IBP) monitoring in many centers. Continuous noninvasive blood pressure (CNBP) measurement using the volume-clamp method is a noninvasive alternative method used in ICU. No data on CNBP reliability are available in the electrophysiology lab during AF ablation, where rhythm variations are common. BACKGROUND: The objective of the present study was to compare continuous noninvasive arterial pressure measured with the ClearSight device (Edwards Lifesciences, Irvine, CA, USA) with invasive radial artery pressure used as the reference method during AF ablation. METHODS: We prospectively enrolled 55 consecutive patients (age 62 ± 11 years, 80% male) undergoing transcatheter AF ablation (62% paroxysmal, 38% persistent) at our center. Standard of care IBP monitoring via a radial cannula and a contralateral noninvasive finger volume-clamp CNBP measurement device were positioned simultaneously in all patients for the entire procedure. Bland-Altman analysis was used to analyze the agreement between the two techniques. RESULTS: A total of 1219 paired measurements for systolic, diastolic, and mean arterial pressure were obtained in 55 subjects, with a mean (SD) of 22 (9) measurements per patient. The mean bias (SD) was -12.97 (13.89) mmHg for systolic pressure (level of agreement -14.24-40.20; correlation coefficient 0.84), -1.85 (8.52) mmHg for diastolic pressure (level of agreement -18.54-14.84; correlation coefficient 0.77) and 2.31 (8.75) mmHg for mean pressure (level of agreement -14.84-19.46; correlation coefficient 0.85). CONCLUSION: In patients undergoing AF ablation, CNBP monitoring with the ClearSight device showed acceptable agreement with IBP monitoring. Larger studies are needed to confirm the potential clinical implications of continuous noninvasive BP monitoring during AF ablation.

15.
Europace ; 25(3): 1116-1125, 2023 03 30.
Article in English | MEDLINE | ID: mdl-36691737

ABSTRACT

AIMS: Permanent pacemaker implantation (PPM-I) remains nowadays the most important drawback of transcatheter aortic valve replacement (TAVR) procedure and the optimal strategy of delayed conduction disturbances (CDs) in these patients is unclear. The study aimed to validate an ambulatory electrocardiogram (ECG) monitoring through a 30 s spot ambulatory digital mobile ECG (AeECG), by using KardiaMobile-6L device in a 30-day period after TAVR procedure. METHODS AND RESULTS: Between March 2021 and February 2022, we consecutively enrolled all patients undergoing TAVR procedure, except pacemaker (PM) carriers. At discharge, all patients were provided of a KardiaMobile-6L device and a spot digital ECG (eECG) recording 1 month schedule. Clinical and follow-up data were collected, and eECG schedule compliance and recording quality were explored. Among 151 patients without pre-existing PM, 23 were excluded for pre-discharge PPM-I, 18 failed the KardiaMobile-6L training phase, and 10 refused the device. Delayed CDs with a Class I/IIa indication for PPM-I occurred in eight patients (median 6 days). Delayed PPM-I vs. non-delayed PPM-I patients were more likely to have longer PR and QRS intervals at discharge. PR interval at discharge was the only independent predictor for delayed PPM-I at multivariate analysis. The overall eECG schedule compliance was 96.5%. None clinical adverse events CDs related were documented using this new AeECG monitoring modality. CONCLUSION: A strategy of 30 s spot AeECG is safe and efficacious in delayed CDs monitoring after TAVR procedure with a very high eECG schedule level of compliance.


Subject(s)
Aortic Valve Stenosis , Pacemaker, Artificial , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/methods , Cardiac Pacing, Artificial/methods , Treatment Outcome , Risk Factors , Cardiac Conduction System Disease/etiology , Electrocardiography , Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/surgery , Aortic Valve/surgery
16.
J Interv Card Electrophysiol ; 66(3): 711-722, 2023 Apr.
Article in English | MEDLINE | ID: mdl-36331681

ABSTRACT

BACKGROUND: Cryoballoon ablation (CBA) is an effective first-line treatment for symptomatic atrial fibrillation (AF), as recently demonstrated by three randomized trials. This sub-analysis of the Cryo Global Registry aims to examine current clinical practices of first-line CBA. METHODS: AF patients treated with first-line CBA were compared to CBA in antiarrhythmic drug (AAD)-refractory patients at 12 months. Efficacy was examined using time-to-first atrial arrhythmia recurrence following a 90-day blanking period. Healthcare utilization was evaluated by repeat ablations and hospitalizations. Disease burden was examined by assessing quality of life (QOL) and patients' reporting of symptoms. RESULTS: Of 1394 patients, 433 (31.1%) were treated with first-line CBA, which was more frequent in high-volume centers. Serious procedure-related adverse event rates were similar. Efficacy at 12 months was higher in the first-line group (87.8 vs. 81.6%, HRunadj 0.64 (95% CI 0.47-0.88); p < 0.01) regardless of the centers' CBA experience; when controlling for baseline characteristics, the difference was not significant (HRadj 0.87 (95% CI 0.56-1.37); p = 0.55). No difference was observed in repeat ablations and hospitalizations between cohorts. First-line patients experienced a larger mean reduction in symptoms and were prescribed AADs at a lower rate at 12-month follow-up (9.7 vs. 29.9%). QOL improved in both cohorts from baseline to 12 months with no significant difference between groups (p = 0.29). CONCLUSIONS: In this global real-world experience, first-line CBA in patients with symptomatic AF is effective, with a larger symptom reduction compared with CBA after AAD failure and without a difference in healthcare utilization at mid-term follow-up. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02752737.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Humans , Anti-Arrhythmia Agents/therapeutic use , Cost of Illness , Cryosurgery/adverse effects , Patient Acceptance of Health Care , Quality of Life , Recurrence , Treatment Outcome
17.
Int J Cardiol ; 365: 49-56, 2022 10 15.
Article in English | MEDLINE | ID: mdl-35907505

ABSTRACT

BACKGROUND: Safety and efficacy of leadless pacemakers (L-PM) have been demonstrated in multiple clinical trials, but real-world data on patient selection, implantation technique, and peri-procedural patient management in a clinical practice setting are lacking. METHODS: Consecutive patients undergoing L-PM implantation in 14 Italian centers were followed in a prospective, multicentre, observational project. Data on baseline patient characteristics, clinical indications, implantation procedure, and peri-procedural patient management were collected. The rate and nature of device-related complications were also recorded. RESULTS: A total of 782 L-PM patients (68.4% male, 75.6 ± 12.4 years) were included in the analysis. The main patients-related reason leading to the choice of implanting a L-PM rather than a conventional PM was the high-risk of device infection (29.5% of cases). The implantation success rate was 99.2%. The median duration of the procedure was 46 min. In 90% of patients the device was implanted in the septum. Of patients on oral anticoagulant therapy (OAT) (n = 498) the implantation procedure was performed without interrupting (17.5%) or transiently interrupting OAT without heparin bridging (60.6%). During a median follow-up of 20 months major device-related complications occurred in 7 patients (0.9%): vascular access-site complications in 3 patients, device malfunction in 2 patients, pericardial effusion/cardiac tamponade in one patient, device migration in one patient. CONCLUSIONS: In the real world setting of Italian clinical practice L-PM is often reserved for patients at high-risk of infection. The implantation success rate was very high and the risk of major complications was low. Peri-procedural management of OAT was consistent with available scientific evidence.


Subject(s)
Pacemaker, Artificial , Pericardial Effusion , Equipment Design , Female , Humans , Male , Pacemaker, Artificial/adverse effects , Pericardial Effusion/etiology , Prospective Studies , Time Factors , Treatment Outcome
18.
J Cardiol Cases ; 25(5): 272-274, 2022 May.
Article in English | MEDLINE | ID: mdl-35582080

ABSTRACT

A 63-year-old man with hypertension and 3-vessel coronary artery disease previously treated with coronary artery bypass graft was admitted to our emergency room complaining of chest pain. He had undergone pacemaker implant 5 months before due to paroxysmal advanced atrioventricular block. Electrocardiography and troponin testing were unremarkable. Echocardiography and chest X-ray ruled out lead displacement and perforation. Interrogation showed normal parameters [right atrium: impedance 550 Ohm bipolar, sensing 2.4 mV bipolar; threshold 0.50 V/0.4 ms bipolar; right ventricle (RV): impedance 580 Ohm bipolar, sensing > 25 mV bipolar; threshold 1.5 V/0.4 ms bipolar and 0.4 V/0.4 ms unipolar]. Pain was evoked only during RV pacing. An electrophysiology study demonstrated painful RV pacing from multiple sites. We hypothesized that pain was associated with pacing-induced dyssynchrony. His-bundle pacing (HBP) was considered as a solution. We achieved HBP with a bipolar fixed-screw catheter connected to a cardiac resynchronization therapy pacemaker generator. During HBP above threshold (4.00 V/1.00 ms) the patient did not complain of any pain. He was discharged 3 days later pain-free with His-bundle lead amplitude set at 5.00 V/1.00 ms. After 6 months the patient was asymptomatic, with the device showing normal functioning. This is the first clinical experience of painful RV pacing treated with HBP. .

19.
J Cardiovasc Electrophysiol ; 33(7): 1414-1424, 2022 07.
Article in English | MEDLINE | ID: mdl-35524404

ABSTRACT

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.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Catheter Ablation/adverse effects , Humans , Pulmonary Veins/surgery , Recurrence , Registries , Treatment Outcome
20.
J Interv Card Electrophysiol ; 65(1): 103-110, 2022 Oct.
Article in English | MEDLINE | ID: mdl-35435630

ABSTRACT

PURPOSE: Real-world safety data on the use of transcatheter pacing systems particularly in very elderly patients is still limited. The aim of this analysis was to investigate the effect of age on the safety and efficacy of leadless pacemaker implant. METHODS: From May 2016 through July 2019, 577 patients were implanted with a leadless single-chamber pacemaker according to current pacing indication in 15 Italian cardiologic centers. The population was divided into age quartiles for evaluation, including (1) < 70 years, (2) 70-77 years, (3) 78-83 years, and (4) ≥ 83 years. Procedural data, complications, and electrical parameters were collected at baseline and during the follow-up. RESULTS: Procedural-related complication occurrence was very low (< 1.0%) and similar in the four subgroups according to age even if the older patients were more frail. No cardiac tamponade was reported. Among the groups, no difference was observed in procedural time, fluoroscopy time duration, and electrical parameters (mean pacing impedance: 750 ± 192 and 599 ± 156, mean pacing threshold: 0.7 ± 0.5 and 0.7 ± 0.6, and mean right ventricular sensing 10.7 ± 6.1 and 11.5 ± 4.8 at implant and last follow-up, respectively). CONCLUSIONS: The reported data demonstrated a high degree of safety during leadless implant across all patient ages. Procedural complications and device electrical measurements were similar among the different ages.


Subject(s)
Arrhythmias, Cardiac , Pacemaker, Artificial , Aged , Arrhythmias, Cardiac/therapy , Cardiac Pacing, Artificial , Equipment Design , Humans , Prospective Studies , Treatment Outcome
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