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1.
J Clin Med ; 12(20)2023 Oct 15.
Article in English | MEDLINE | ID: mdl-37892671

ABSTRACT

BACKGROUND: The safety and efficacy of an uninterrupted direct anticoagulation (DOAC) strategy during catheter ablation (CA) for atrial fibrillation (AF) has not been fully investigated with different ablation techniques. METHODS: We evaluated consecutive AF patients undergoing catheter ablation with three different techniques. All patients were managed with an uninterrupted DOAC strategy. The primary endpoint was the rate of periprocedural thromboembolic and bleeding events. The secondary endpoints of the study were the rate of MACE and bleeding events at one-year follow-up. RESULTS: In total, 162 patients were enrolled. Overall, 53 were female and the median age was 60 [55.5-69.5] years. The median CHA2DS2-VASc and HAS-BLED scores were 2 [1-4] and 2 [1-2], respectively. In total, 16 patients had a past stroke or TIA while 11 had a predisposition or a history of bleeding. The CA procedure was performed with different techniques: RF 43%, cryoballoon 37%, or laser-balloon 20%. Overall, 35.8% were on rivaroxaban, 20.4% were on edoxaban, 6.8% were on apixaban, and 3.7% were on dabigatran. All other patients were all naïve to DOACs; the first anticoagulant dose was given before the ablation procedure. As for periprocedural complications, we found three groin hematomas not requiring interventions, one ischemic stroke, and one systemic air embolism (the last two likely due to several catheter changes through the transeptal sheath). Five patients reached the secondary endpoints: one patient for a myocardial infarction while four patients experienced minor bleeding during 1-year follow-up. CONCLUSIONS: Our results corroborate the safety and the efficacy of uninterrupted DOAC strategy in patients undergoing CA for AF, regardless of the ablation technique.

2.
J Cardiovasc Electrophysiol ; 34(12): 2443-2451, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37767727

ABSTRACT

INTRODUCTION: Regardless of the catheter ablation (CA) for atrial fibrillation (AF) strategy, the role of early recurrences during the blanking period (BP) is still unclear. Our aim was to evaluate atrial tachyarrhythmias (ATAs) recurrences during the BP after CA with the laser-balloon (LB) technique. METHODS: Consecutive patients undergoing LBCA were enrolled. Primary outcome of the study was the overall crude ATA recurrence rate during the BP. ATA recurrences after the BP and in-hospital readmissions during the BP were deemed secondary outcomes. RESULTS: Two hundred and twenty-four patients underwent CA with the LB. Median age was 63.0 (55.5-69.5) years and 74.1% were males. 28.6% were persistent AF patients, and 34.8% of patients were followed up with a loop recorder. 15.6% of patients experienced at least an ATA recurrence during the BP. Male sex, chronic heart failure, persistent AF, and recurrences during the BP were found to be associated with long-term ATA recurrences. Recurrences during the BP remained associated with the outcome of interest at multivariate analysis (hazard ratio [HR] = 12.393, 95% confidence interval [95% CI] = 3.699-41.865, p < .001). An association over time was found between early and late recurrences, with 73.7%, 45.5%, and 10.8% of patients presenting with recurrences at 1-, 2-, and 3-month follow-up being free from recurrences after the BP, respectively. 8.0% of patients were readmitted during the BP: 4.5% for AF electrical cardioversion, and 1.8% for CA of other atrial arrhythmias; no redo CA was performed. CONCLUSION: After adjusting for confounders, ATA recurrences during the BP represent the most significant predictor of ATA recurrences after the BP, regardless of AF pattern.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Humans , Male , Middle Aged , Female , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Treatment Outcome , Time Factors , Catheter Ablation/adverse effects , Catheter Ablation/methods , Recurrence , Pulmonary Veins/surgery , Lasers
3.
Expert Rev Med Devices ; 20(11): 951-961, 2023.
Article in English | MEDLINE | ID: mdl-37712650

ABSTRACT

BACKGROUND: The prognosis for heart failure (HF) patients remains poor, with a high mortality rate, and a marked reduction in quality of life (QOL) and functional status. This study aims to explore the ongoing needs of HF management and the epidemiology of patients followed by Italian HF clinics, with a specific focus on cardiac contractility modulation (CCM). RESEARCH DESIGN AND METHODS: Data from patients admitted to 14 HF outpatients clinics over 4 weeks were collected and compared to the results of a survey open to physicians involved in HF management operating in Italian centers. RESULTS: One hundred and five physicians took part in the survey. Despite 94% of patients receive a regular follow-up every 3-6 months, available therapies are considered insufficient in 30% of cases. Physicians reported a lack of treatment options for 23% of symptomatic patients with reduced ejection fraction (EF) and for 66% of those without reduced EF. Approximately 3% of HF population (two patients per month per HF clinic) meets the criteria for immediate CCM treatment, which is considered a useful option by 15% of survey respondents. CONCLUSIONS: Despite this relatively small percentage, considering total HF population, CCM could potentially benefit numerous HF patients, particularly the elderly, by reducing hospitalizations, improving functional capacity and QOL.

4.
Life (Basel) ; 13(8)2023 Jul 28.
Article in English | MEDLINE | ID: mdl-37629509

ABSTRACT

The difference between subcutaneous implantable cardioverter defibrillators (S-ICDs) and transvenous ICDs (TV-ICDs) concerns a whole extra thoracic implantation, including a defibrillator coil and pulse generator, without endovascular components. The improved safety profile has allowed the S-ICD to be rapidly taken up, especially among younger patients. Reports of its role in different cardiac diseases at high risk of SCD such as hypertrophic and arrhythmic cardiomyopathies, as well as channelopathies, is increasing. S-ICDs show comparable efficacy, reliability, and safety outcomes compared to TV-ICD. However, some technical issues (i.e., the inability to perform anti-bradycardia pacing) strongly limit the employment of S-ICDs. Therefore, it still remains only an alternative to the traditional ICD thus far. This review aims to provide a contemporary overview of the role of S-ICDs compared to TV-ICDs in clinical practice, including technical aspects regarding device manufacture and implantation techniques. Newer outlooks and future perspectives of S-ICDs are also brought up to date.

6.
J Cardiovasc Electrophysiol ; 34(6): 1386-1394, 2023 06.
Article in English | MEDLINE | ID: mdl-37194742

ABSTRACT

INTRODUCTION: Brugada syndrome (BrS) has a dynamic ECG pattern that might be revealed by certain conditions such as fever. We evaluated the incidence and management of ventricular arrhythmias (VAs) related to COVID-19 infection and vaccination among BrS patients carriers of an implantable loop recorder (ILR) or implantable cardioverter-defibrillator (ICD) and followed by remote monitoring. METHODS: This was a multicenter retrospective study. Patients were carriers of devices with remote monitoring follow-up. We recorded VAs 6 months before COVID-19 infection or vaccination, during infection, at each vaccination, and up to 6-month post-COVID-19 or 1 month after the last vaccination. In ICD carriers, we documented any device intervention. RESULTS: We included 326 patients, 202 with an ICD and 124 with an ILR. One hundred and nine patients (33.4%) had COVID-19, 55% of whom developed fever. Hospitalization rate due to COVID-19 infection was 2.76%. After infection, we recorded only two ventricular tachycardias (VTs). After the first, second, and third vaccines, the incidence of non-sustained ventricular tachycardia (NSVT) was 1.5%, 2%, and 1%, respectively. The incidence of VT was 1% after the second dose. Six-month post-COVID-19 healing or 1 month after the last vaccine, we documented NSVT in 3.4%, VT in 0.5%, and ventricular fibrillation in 0.5% of patients. Overall, one patient received anti-tachycardia pacing and one a shock. ILR carriers had no VAs. No differences were found in VT before and after infection and before and after each vaccination. CONCLUSIONS: From this large multicenter study conducted in BrS patients, followed by remote monitoring, the overall incidence of sustained VAs after COVID-19 infection and vaccination is relatively low.


Subject(s)
Brugada Syndrome , COVID-19 , Defibrillators, Implantable , Tachycardia, Ventricular , Humans , Brugada Syndrome/diagnosis , Brugada Syndrome/epidemiology , Brugada Syndrome/therapy , Retrospective Studies , Incidence , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/prevention & control , Arrhythmias, Cardiac/diagnosis , Arrhythmias, Cardiac/epidemiology , Arrhythmias, Cardiac/therapy , Tachycardia, Ventricular/diagnosis , Tachycardia, Ventricular/epidemiology , Tachycardia, Ventricular/therapy , Registries , Vaccination , Follow-Up Studies
7.
Eur Heart J Suppl ; 25(Suppl C): C227-C233, 2023 May.
Article in English | MEDLINE | ID: mdl-37125274

ABSTRACT

Cardiac resynchronization therapy (CRT) via biventricular pacing (BVP) is a well-established therapy for patients with heart failure with reduced ejection fraction and left bundle branch block, who remain symptomatic despite optimal medical therapy. Despite the long-standing clinical evidence, as well as the familiarity of cardiac electrophysiologists with the implantation technique, CRT via BVP cannot be achieved or may result ineffective in up to one-third of the patients. Therefore, new alternative techniques, such as conduction system pacing and left ventricular pacing, are emerging as potential alternatives to this technique, not only in case of BVP failure, but also as a stand-alone first choice due to several potential advantages over traditional CRT. Specifically, due to its procedural characteristics, left bundle branch area pacing appears to be the most convincing technique, showing comparable efficacy outcomes when compared with traditional CRT, not increasing short-term device-related complications, as well as improving procedural times. However, transvenous leads remain a major limitation of all these pacing modalities. To overcome this limit, a leadless left ventricular endocardial pacing has been developed as an additional tool to achieve a left endocardial activation, although being still associated with non-negligible pitfalls, limiting its current use in clinical practice. This article focuses on the current state and latest progresses in cardiac resynchronization therapy.

8.
Eur Heart J Suppl ; 25(Suppl C): C331-C336, 2023 May.
Article in English | MEDLINE | ID: mdl-37125308

ABSTRACT

Heart failure (HF) is a major and still growing medical problem and is characterized by episodes of acute decompensation that are associated with a negative prognosis and a significant burden on the patients, doctors, and healthcare resources. Early detection of incipient HF may allow outpatient treatment before patients severely decompensate, thus reducing HF hospitalizations and related costs. The HeartLogic™ algorithm is an automatic, remotely managed system combining data directly related to HF pathophysiology into a single score, the HeartLogic™ index. This index proved to be effective in predicting the risk of incipient HF decompensation, allowing to redistribute resources from low-risk to high-risk patients in a timely and cost-saving manner. The alert-based remote management system seems more efficient than the one based on scheduled remote transmission in terms of caregivers' workload and alert detection timing. The widespread application of the HeartLogic™ algorithm requires the resolution of logistical and financial issues and the adoption of a pre-defined, functional workflow. In this paper, we reviewed general aspects of remote monitoring in HF patients, the functioning and pathophysiological basis of the HeartLogic index, its efficiency in the management of HF patients, and the economic effects and the organizational revolution associated with its use.

9.
Int J Mol Sci ; 24(9)2023 Apr 27.
Article in English | MEDLINE | ID: mdl-37175633

ABSTRACT

Genetic susceptibility may influence ischemic heart disease (IHD) predisposition and affect coronary blood flow (CBF) regulation mechanisms. The aim of this study was to investigate the association among single nucleotide polymorphisms (SNPs) of genes encoding for proteins involved in CBF regulation and IHD. A total of 468 consecutive patients were enrolled and divided into three groups according to coronary angiography and intracoronary functional tests results: G1, patients with coronary artery disease (CAD); G2, patients with coronary microvascular dysfunction (CMD); and G3, patients with angiographic and functionally normal coronary arteries. A genetic analysis of the SNPs rs5215 of the potassium inwardly rectifying channel subfamily J member 11 (KCNJ11) gene and rs1799983 of the nitric oxide synthase 3 (NOS3) gene, respectively encoding for the Kir6.2 subunit of ATP sensitive potassium (KATP) channels and nitric oxide synthase (eNOS), was performed on peripheral whole blood samples. A significant association of rs5215_G/G of KCNJ11 and rs1799983_T/T of NOS3 genes was detected in healthy controls compared with CAD and CMD patients. Based on univariable and multivariable analyses, the co-presence of rs5215_G/G of KCNJ11 and rs1799983_T/T of NOS3 may represent an independent protective factor against IHD, regardless of cardiovascular risk factors. This study supports the hypothesis that SNP association may influence the crosstalk between eNOS and the KATP channel that provides a potential protective effect against IHD.


Subject(s)
Coronary Artery Disease , Myocardial Ischemia , Humans , Adenosine Triphosphate , Coronary Artery Disease/genetics , Genetic Predisposition to Disease , Myocardial Ischemia/genetics , Nitric Oxide Synthase/genetics , Nitric Oxide Synthase Type III/genetics , Nitric Oxide Synthase Type III/metabolism , Polymorphism, Single Nucleotide
10.
Rev Port Cardiol ; 42(8): 711-717, 2023 08.
Article in English, Portuguese | MEDLINE | ID: mdl-37085085

ABSTRACT

INTRODUCTION AND OBJECTIVES: The incidence of device infection has increased over time and is associated with increased mortality in patients with cardiac implantable electronic devices (CIEDs). Gentamicin-impregnated collagen sponges (GICSs) are useful in preventing surgical site infection (SSI) in cardiac surgery. Nevertheless, to date, there is no evidence concerning their use in CIED procedures. Our study aims to determine the effectiveness of treatment with GICSs in preventing CIED infection. METHODS: A total of 2986 adult patients who received CIEDs between 2010 and 2020 were included. Before device implantation, all patients received routine periprocedural systemic antibiotic prophylaxis. The study endpoints were the CIED infection rate at one year and the effectiveness of the use of GICSs in reducing CIED infection. RESULTS: Among 1524 pacemaker, 942 ICD and 520 CRT implantations, CIED infection occurred in 36 patients (1.2%). Early reintervention (OR 9 [95% CI 3.180-25.837], p<0.001), pocket hematoma (OR 11 [95% CI 4.195-28.961], p<0.001), diabetes (OR 2.9 [95% CI 1.465-5.799], p=0.002) and prolonged procedural time (OR 1.02 [95% CI 1.008-1.034], p=0.001) were independent risk factors for CIED infection. Treatment with GICSs reduced CIED infections significantly ([95% CI -0.031 to -0.001], p<0.001). CONCLUSIONS: The use of GICSs may help in reducing infections associated with CIED implantation.


Subject(s)
Defibrillators, Implantable , Pacemaker, Artificial , Prosthesis-Related Infections , Adult , Humans , Defibrillators, Implantable/adverse effects , Gentamicins , Propensity Score , Pacemaker, Artificial/adverse effects , Risk Factors , Prosthesis-Related Infections/prevention & control , Prosthesis-Related Infections/etiology , Retrospective Studies
12.
G Ital Cardiol (Rome) ; 24(3): 241-244, 2023 Mar.
Article in Italian | MEDLINE | ID: mdl-36853162

ABSTRACT

BACKGROUND: This report describes the findings of the 2020 Italian Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC). METHODS: Data collection was retrospective. A standardized questionnaire was completed by each of the participating centers. RESULTS: A total of 10 378 ablation procedures were performed by 66 institutions. Most centers (70%) have an electrophysiology laboratory, and 23% a hybrid cardiac surgery laboratory. All centers have a 3D mapping system. The median number of electrophysiologists and nurses involved in the electrophysiology laboratory was 3.5 and 3, respectively. An electrophysiology technician was involved in 35% of all centers. In 88.2% of cases, catheter ablation was performed for supraventricular arrhythmias; the most frequently treated arrhythmia was atrial fibrillation (39.4%), followed by atrioventricular nodal reentrant tachycardia (18.6%), and common atrial flutter (10.6%). In 72.9% of patients, catheter ablation was performed using a 3D mapping system, with a "near-zero" fluoroscopic approach in 37.7% of all patients. CONCLUSIONS: The 2020 Italian Catheter Ablation Registry confirmed that the electrophysiology activity was markedly affected by the COVID-19 pandemic; atrial fibrillation is the most frequently treated arrhythmia with an increasing number of procedures performed with a 3D mapping system and a "near-zero" approach.


Subject(s)
Atrial Fibrillation , COVID-19 , Catheter Ablation , Humans , Atrial Fibrillation/surgery , Pandemics , Retrospective Studies , Registries
13.
Int J Cardiol ; 377: 52-59, 2023 04 15.
Article in English | MEDLINE | ID: mdl-36736670

ABSTRACT

BACKGROUND: His- Purkinje system pacing (HPSP) techniques have been proposed as alternative to biventricular pacing (BVP) and right ventricular pacing (RVP). OBJECTIVE: To compare data regarding clinical, procedural and lead outcomes associated with different pacing techniques. METHODS: An accurate search of online scientific libraries (from inception to May, 12,022) was performed. Thirty-three studies were included in the meta-analysis involving 4386 patients, of whom 1324 receiving RVP, 1032 patients receiving BVP, 1069 patients receiving his-bundle pacing (HBP) and 968 patients receiving left bundle branch pacing (LBBP). RESULTS: LBBP provided a statistically significant increase in LVEF relative to HBP (0.4473 [0.0584; 0.8361] p = 0.0242) and BVP (0.6733 [0.4734; 0.8732] p < 0.0001) in patients with cardiac resynchronization therapy indication. LBBP and HBP significantly decreased QRS duration as compared to BVP, with largest QRS narrowing obtained by LBBP (-0.4951 [-0.9077; -0.0824] p = 0.0187). As compared to LBBP, HBP was associated with a significant increase of pacing threshold (p = 0.0369) and significant reduction of R-wave amplitude over time (p = 0.027). LBBP was associated with significant reduction in RR of hospitalization for HF (HFH) as compared to both BVP (p = 0.0343) and HBP (p = 0.0476), whereas, as compared to RVP, the risk of lead issues was significantly higher with BVP (p = 0.0424) and HBP (p = 0.0298), but not for LBBP (p = 0.425). CONCLUSIONS: As compared to other pacing techniques, LBBP significantly improved LVEF, narrowed QRS duration and reduced HFHs, with steadily lower capture thresholds and higher R-wave amplitude, and without increasing lead issues.


Subject(s)
Bundle of His , Cardiac Resynchronization Therapy , Humans , Cardiac Pacing, Artificial/methods , Network Meta-Analysis , Electrocardiography , Heart Conduction System , Cardiac Resynchronization Therapy/methods , Treatment Outcome , Ventricular Function, Left
15.
J Clin Med ; 12(2)2023 Jan 12.
Article in English | MEDLINE | ID: mdl-36675547

ABSTRACT

The feasibility and effectiveness of virtual visits (VVs) for cardiac electrophysiology patients are still unknown. We aimed to assess the feasibility and effectiveness of VVs as compared to in-person visits, and to describe patient experience with virtual care in clinical electrophysiology. We prospectively enrolled patients scheduled to receive a clinical electrophysiology evaluation, dividing them in two groups: a VV group and an in-person visit group. Outcomes of interest were: (1) improvement in symptoms after the index visit, (2) disappearance of remote monitoring (RM) alerts at follow-up, (3) necessity of urgent hospitalization and (4) patient satisfaction measured by the Patient Satisfaction Questionnaire-18 (PSQ-18). This study included 162 patients in the VV group and 185 in the in-office visit group. As compared to in-person visits, VVs resulted in a similar reduction in RM alerts (51.5% vs. 43.2%, p-value 0.527) and in symptomatic patient rates (73.6% vs. 56.9%, p-value 0.073) at follow-up, without differences in urgent hospitalization rates (p-value 0.849). Patient satisfaction with VVs was higher than with in-person evaluation (p-value < 0.012). VVs proved to be as feasible and as effective as in-person visits, with high patient satisfaction. A hybrid model of care including VVs and in-person visits may become the new standard of care after the COVID-19 pandemic is over.

16.
Intern Emerg Med ; 18(1): 137-149, 2023 01.
Article in English | MEDLINE | ID: mdl-36352300

ABSTRACT

BACKGROUND: The subsequent waves of the COVID-19 pandemic in Italy had a major impact on cardiac care. METHODS: A survey to evaluate the dynamic changes in arrhythmia care during the first five waves of COVID-19 in Italy (first: March-May 2020; second: October 2020-January 2021; third: February-May 2021; fourth: June-October 2021; fifth: November 2021-February 2022) was launched. RESULTS: A total of 127 physicians from arrhythmia centers (34% of Italian centers) took part in the survey. As compared to 2019, a reduction in 40% of elective pacemaker (PM), defibrillators (ICD), and cardiac resynchronization devices (CRT) implantations, with a 70% reduction for ablations, was reported during the first wave, with a progressive and gradual return to pre-pandemic volumes, generally during the third-fourth waves, slower for ablations. For emergency procedures (PM, ICD, CRT, and ablations), recovery from the initial 10% decline occurred in most cases during the second wave, with some variability. However, acute care for atrial fibrillation, electrical cardioversions, and evaluations for syncope showed a prolonged reduction of activity. The number of patients with devices which started remote monitoring increased by 40% during the first wave, but then the adoption of remote monitoring declined. CONCLUSIONS: The dramatic and profound derangement in arrhythmia management that characterized the first wave of the COVID-19 pandemic was followed by a progressive return to the volume of activities of the pre-pandemic periods, even if with different temporal dynamics and some heterogeneity. Remote monitoring was largely implemented during the first wave, but full implementation is needed.


Subject(s)
Atrial Fibrillation , COVID-19 , Cardiac Resynchronization Therapy , Defibrillators, Implantable , Humans , Pandemics , Registries , Italy/epidemiology , Electrophysiology
17.
J Clin Med ; 11(21)2022 Nov 06.
Article in English | MEDLINE | ID: mdl-36362811

ABSTRACT

Background: Large-scale studies evaluating long-term recurrence rates in both idiopathic and non-idiopathic PVC catheter ablation (CA) patients have not been reported. Objective: To evaluate the efficacy and safety of idiopathic and non-idiopathic PVC CA, investigating the predictors of acute and long-term efficacy. Methods: This retrospective multicentric study included 439 patients who underwent PVC CA at three institutions from April-2015 to December-2021. Clinical success at 6 months' follow-up, defined as a reduction of at least 80% of the pre-procedural PVC burden, was deemed the primary outcome. The secondary aims of the study were: clinical success at the last available follow-up, predictors of arrhythmic recurrences at long-term follow-up, and safety outcomes. Results: The median age was 51 years, with 24.9% patients being affected suffering from structural heart disease. The median pre-procedural PVC burden was 20.1%. PVCs originating from the RVOT were the most common index PVC observed (29.1%), followed by coronary cusp (CC) and non-outflow tract (OT) LV PVCs (23.1% and 19.0%). The primary outcome at 6 months was reached in 85.1% cases, with a significant reduction in the 24 h% PVC burden (−91.4% [−83.4; −96.7], p < 0.001); long-term efficacy was observed in 82.1% of cases at almost 3-year follow-up. The presence of underlying structural heart disease and non-OT LV region origin (aHR 1.77 [1.07−2.93], p = 0.027 and aHR = 1.96 [1.22−3.14], p = 0.005) was independently associated with recurrences. Conclusion: CA of both idiopathic and non-idiopathic PVCs showed a very good acute and long-term procedural success rate, with an overall low complication. Predictors of arrhythmic recurrence at follow-up were underlying structural heart disease and non-OT LV origin.

18.
J Clin Med ; 11(20)2022 Oct 14.
Article in English | MEDLINE | ID: mdl-36294401

ABSTRACT

(1) Background: Leadless (LL) stimulation is perceived to lower surgical, vascular, and lead-related complications compared to transvenous (TV) pacemakers, yet controlled studies are lacking and real-life experience is non-conclusive. (2) Aim: To prospectively analyse survival and complication rates in leadless versus transvenous VVIR pacemakers. (3) Methods: Prospective analysis of mortality and complications in 344 consecutive VVIR TV and LL pacemaker recipients between June 2015 and May 2021. Indications for VVIR pacing were "slow" AF, atrio-ventricular block in AF or in sinus rhythm in bedridden cognitively impaired patients. LL indication was based on individualised clinical judgement. (4) Results: 72 patients received LL and 272 TV VVIR pacemakers. LL pacemaker indications included ongoing/expected chronic haemodialysis, superior venous access issues, active lifestyle with low pacing percentage expected, frailty causing high bleeding/infectious risk, previous valvular endocarditis, or device infection requiring extraction. No significant difference in the overall acute and long-term complication rate was observed between LL and TV cohorts, with greater mortality occurring in TV due to selection of older patients. (5) Conclusions: Given the low complication rate and life expectancy in this contemporary VVIR cohort, extending LL indications to all VVIR candidates is unlikely to provide clear-cut benefits. Considering the higher costs of LL technology, careful patient selection is mandatory for LL PMs to become advantageous, i.e., in the presence of vascular access issues, high bleeding/infectious risk, and long life expectancy, rendering lead-related issues and repeated surgery relevant in the long-term perspective.

19.
J Clin Med ; 11(11)2022 Jun 04.
Article in English | MEDLINE | ID: mdl-35683593

ABSTRACT

BACKGROUND: Direct oral anticoagulants (DOACs) are the preferred anticoagulant drugs for the prevention of atrial fibrillation (AF)-related thromboembolic complications and for the treatment and the prevention of recurrences of venous thromboembolism (VTE). The evaluation of self-reported adverse drug reactions (ADRs) available from databases of drug-regulatory agencies such as the Italian Medicines Agency (AIFA) pharmacovigilance database represents a novel aid to guide decision making. OBJECTIVE: To assess the safety profile of DOACs by analyzing ADR rates in the real-world Italian scenario. METHODS: Post-marketing surveillance data recorded by the National Pharmacovigilance Network were retrieved for the time period 2017-2021 from the AIFA online site. The following data were collected for each DOAC: total ADR number, serious ADR number, gastrointestinal (GI) ADR, intracranial hemorrhage events (ICH ADR), and more frequently reported ADR for the study year. The safety profile was expressed by the risk index (RI). RESULTS: Rivaroxaban use was associated with consistent and stable low rates of serious ADR, GI ADR, and ICH ADR across the 5-year study period. Rivaroxaban and apixaban showed the lowest RI for serious ADR and GI ADR, while rivaroxaban use was associated with significantly lower ICH events as compared to apixaban. Dabigatran was related to the highest RIs for every ADR class, in particular GI ADRs. CONCLUSIONS: DOACs presented an acceptable safety profile in the current post-market analysis. However, rivaroxaban and apixaban were associated with more favorable safety profiles as compared to dabigatran, while rivaroxaban provoked statistically significantly fewer ICH events as compared to apixaban.

20.
Heart Rhythm ; 19(2): 206-216, 2022 02.
Article in English | MEDLINE | ID: mdl-34710561

ABSTRACT

BACKGROUND: Cardiac implantable electronic device (CIED) implantation rates as well as the clinical and procedural characteristics and outcomes in patients with known active coronavirus disease 2019 (COVID-19) are unknown. OBJECTIVE: The purpose of this study was to gather information regarding CIED procedures during active COVID-19, performed with personal protective equipment, based on an international survey. METHODS: Fifty-three centers from 13 countries across 4 continents provided information on 166 patients with known active COVID-19 who underwent a CIED procedure. RESULTS: The CIED procedure rate in 133,655 hospitalized COVID-19 patients ranged from 0 to 16.2 per 1000 patients (P <.001). Most devices were implanted due to high-degree/complete atrioventricular block (112 [67.5%]) or sick sinus syndrome (31 [18.7%]). Of the 166 patients in the study survey, the 30-day complication rate was 13.9% and the 180-day mortality rate was 9.6%. One patient had a fatal outcome as a direct result of the procedure. Differences in patient and procedural characteristics and outcomes were found between Europe and North America. An older population (76.6 vs 66 years; P <.001) with a nonsignificant higher complication rate (16.5% vs 7.7%; P = .2) was observed in Europe vs North America, whereas higher rates of critically ill patients (33.3% vs 3.3%; P <.001) and mortality (26.9% vs 5%; P = .002) were observed in North America vs Europe. CONCLUSION: CIED procedure rates during known active COVID-19 disease varied greatly, from 0 to 16.2 per 1000 hospitalized COVID-19 patients worldwide. Patients with active COVID-19 infection who underwent CIED implantation had high complication and mortality rates. Operators should take these risks into consideration before proceeding with CIED implantation in active COVID-19 patients.


Subject(s)
Atrioventricular Block , COVID-19 , Infection Control , Postoperative Complications , Prosthesis Implantation , SARS-CoV-2/isolation & purification , Sick Sinus Syndrome , Aged , Atrioventricular Block/epidemiology , Atrioventricular Block/therapy , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/therapy , Comorbidity , Defibrillators, Implantable/statistics & numerical data , Female , Global Health/statistics & numerical data , Humans , Infection Control/instrumentation , Infection Control/methods , Infection Control/organization & administration , Male , Middle Aged , Mortality , Outcome Assessment, Health Care , Pacemaker, Artificial/statistics & numerical data , Postoperative Complications/diagnosis , Postoperative Complications/mortality , Prosthesis Implantation/adverse effects , Prosthesis Implantation/instrumentation , Prosthesis Implantation/mortality , Risk Factors , Sick Sinus Syndrome/epidemiology , Sick Sinus Syndrome/therapy , Surveys and Questionnaires
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