Single-Chamber Leadless Cardiac Pacemaker in Patients Without Atrial Fibrillation: Findings From Campania Leadless Registry

Introduction:Little is known about the clinical performance of single-chamber leadless pacemaker (LLPM) in patients without atrial fibrillation (AF) as pacing indication. The aim of this study was to describe the clinical characteristics of patients who underwent single chamber LLPM implantation at three tertiary referral centers and to compare the safety and effectiveness of the single-chamber LLPM among patients with or without AF.Materials and Methods:All the consecutive patients who underwent LLPM implantation at three referral centers were analyzed. The indications to LLPM in a real-world setting were described. The study population was divided into two groups according to AF as pacing indication. We assessed the procedure-related complications; moreover, we compared syncope, cardiac hospitalization, pacemaker syndrome, and all-cause death recurrence during the follow-up between patients with and without AF as pacing indication.Results:A total of 140 consecutive patients (mean age, 76.7 ± 11.24 years, men 64.3%) were included in the study. The indication to implantation of LLPM was permanent AF with slow ventricular response (n: 67; 47.8%), sinus node dysfunction (n: 25; 17.8%), third atrioventricular block (AVB) (n: 20; 14.2%), second-degree AVB (n: 18; 12.8%), and first degree AVB (n: 10; 7.1%). A total of 7 patients (5%) experienced perioperative complications with no differences between the AF vs. non-AF groups. During a mean follow-up of 606.5 ± 265.9 days, 10 patients (7.7%) died and 7 patients (5.4%) were reported for cardiac hospitalization; 5 patients (3.8%) experienced syncope; no patients showed pacemaker syndrome. No significant differences in the clinical events between the groups were shown. The Kaplan–Meier analysis for the combined endpoints did not show significant differences between the AF and non-AF groups [hazard ratio (HR): 0.94, 95% CI: 0.41–2.16; p = 0.88].Conclusion:Our real-world data suggest that LLPM may be considered a safe and reasonable treatment in patients without AF in need of pacing. Further studies are needed to confirm these preliminary results.

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Feasibility of using real-world data in the evaluation of cardiac ablation catheters: a test-case of the National Evaluation System for Health Technology Coordinating Center

BMJ Surgery, Interventions, & Health Technologies ◽

10.1136/bmjsit-2021-000089 ◽

2021 ◽

Vol 3 (1) ◽

pp. e000089

Author(s):

Sanket S Dhruva ◽

Guoqian Jiang ◽

Amit A Doshi ◽

Daniel J Friedman ◽

Eric Brandt ◽

...

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

Ventricular Tachycardia ◽

Health Systems ◽

Real World ◽

Persistent Atrial Fibrillation ◽

Cardiac Ablation ◽

Real World Data ◽

Related Hospitalisation

ObjectivesTo determine the feasibility of using real-world data to assess the safety and effectiveness of two cardiac ablation catheters for the treatment of persistent atrial fibrillation and ischaemic ventricular tachycardia.DesignRetrospective cohort.SettingThree health systems in the USA.ParticipantsPatients receiving ablation with the two ablation catheters of interest at any of the three health systems.Main outcome measuresFeasibility of identifying the medical devices and participant populations of interest as well as the duration of follow-up and positive predictive values (PPVs) for serious safety (ischaemic stroke, acute heart failure and cardiac tamponade) and effectiveness (arrhythmia-related hospitalisation) clinical outcomes of interest compared with manual chart validation by clinicians.ResultsOverall, the catheter of interest for treatment of persistent atrial fibrillation was used for 4280 ablations and the catheter of interest for ischaemic ventricular tachycardia was used 1516 times across the data available within the three health systems. The duration of patient follow-up in the three health systems ranged from 91% to 97% at ≥7 days, 89% to 96% at ≥30 days, 77% to 90% at ≥6 months and 66% to 84% at ≥1 year. PPVs were 63.4% for ischaemic stroke, 96.4% for acute heart failure, 100% at one health system for cardiac tamponade and 55.7% for arrhythmia-related hospitalisation.ConclusionsIt is feasible to use real-world health system data to evaluate the safety and effectiveness of cardiac ablation catheters, though evaluations must consider the implications of variation in follow-up and endpoint ascertainment among health systems.

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Management and outcomes of real-world use of non-vitamin-K oral anticoagulants (NOACs) in patients with atrial fibrillation: experience of a dedicated NOAC clinic

Netherlands Heart Journal ◽

10.1007/s12471-019-01330-y ◽

2019 ◽

Vol 27 (12) ◽

pp. 605-612 ◽

Cited By ~ 1

Author(s):

A. J. W. M. de Veer ◽

N. Bennaghmouch ◽

M. C. E. F. Wijffels ◽

J. M. ten Berg

Keyword(s):

Atrial Fibrillation ◽

Adverse Drug Reactions ◽

Vitamin K ◽

Real World ◽

Oral Anticoagulants ◽

Daily Practice ◽

Drug Reactions ◽

Real World Data ◽

First Choice

Abstract Background Current guidelines recommend non-vitamin‑K oral anticoagulants (NOACs) as the first-choice therapy for stroke prevention in patients with atrial fibrillation (AF). The use of drugs in a clinical trial setting differs from that in real-world populations. Real-world data are important to accrue more heterogeneous patient populations with respect to co-morbidities and co-medication use. The aim of this study was to evaluate the use of NOACs in daily practice in a large tertiary hospital in the Netherlands. Methods A single-centre prospective study was conducted among all patients with AF using a NOAC in the St. Antonius Hospital between 2013 and June 2017. The outcomes were the rates of any bleeding, stroke/transient ischaemic attack, mortality, discontinuation rate and adverse drug reactions. Results In total, 799 patients were enrolled with a mean follow-up of 1.7 years. Mean age was 69.8 (SD ± 11) and 61.2% were male. Mean CHA2DS2-VASc score was 2.8 (SD ± 1.6) and mean HAS-BLED score was 1.4 (SD ± 0.9). Bleeding occurred in 6.0, major bleeding in 1.8, stroke in 1.2 patients per 100 patient-years, and 87 patients (10.9%) died during the follow-up period. Adverse drug reactions were reported by 59 patients (7.4%). Finally, 249 patients (31.2%) reported a temporary interruption and 132 (16.5%) permanent discontinuation of NOAC treatment, of whom 33 (25%) patients switched to a vitamin‑K antagonist. Conclusions We observed low rates of bleeding and adverse drug reactions. However, rates of mortality and discontinuation were relatively high. These results could possibly be explained by the real-world nature of the data including higher-risk patients.

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P1011Cryptogenic stoke and asymptomatic atrial fibrillation in a real world population: a single centre, implantable loop recorder study

EP Europace ◽

10.1093/europace/euaa162.111 ◽

2020 ◽

Vol 22 (Supplement_1) ◽

Author(s):

M Faustino ◽

V Di Stefano ◽

R Franciotti ◽

N Furia ◽

E Di Girolamo ◽

...

Keyword(s):

Atrial Fibrillation ◽

Real World ◽

Cryptogenic Stroke ◽

Daily Practice ◽

World Population ◽

Real World Data ◽

Loop Recorder ◽

Cardiac Monitor ◽

Mean Time

Abstract Funding Acknowledgements None Background The incidence of atrial fibrillation (AF) in cryptogenic stroke (CS) patients has been studied in carefully controlled clinical trials, but real-world data are limited. Purpose Aim of this study was to investigated the incidence of AF in clinical practice among CS patients with an implantable cardiac monitor (ICM) recommended (IIA) for AF detection. Methods Patients with CS admitted to our Stroke Unit were included in the study. Patiens received an ICM and were monitored for up to 2 years for AF detection (in-hospital clinic and remote monitoring). All detected AF episodes (≥30 sec) were considered. Results From March 2016 to March 2019, 58 patients (mean age 68 ±12 years, 67% male) received an ICM to detect AF after a CS. No patients were lost during follow-up. AF was detected in 23 patients (40% overall; AF group mean age 72 ± 11 years; 65% male) after a mean time of 6 months from ICM implantation (ranging from 2 days up to 2 years) and 8 months after CS (ranging from 1 month up to 2 years). In these AF patients anticoagulant treatment was prescribed, and no further stroke was reported. Conclusions AF episodes were detected via continuous monitoring with ICMs in 40% of implanted CS patients. AF after CS was asymptomatic and thus unlikely to be detected by strategies based on intermittent short-term recordings. Therefore, ICMs should be considered as part of daily practice in the evaluation of CS patients. Abstract Figure 1. Detection rate over time

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928-P: Dulaglutide Has Higher Adherence and Persistence than Semaglutide and Exenatide QW: 6-Month Follow-Up from U.S. Real-World Data

Diabetes ◽

10.2337/db20-928-p ◽

2020 ◽

Vol 69 (Supplement 1) ◽

pp. 928-P

Author(s):

REEMA MODY ◽

MARIA YU ◽

BAL K. NEPAL ◽

MANIGE KONIG ◽

MICHAEL GRABNER

Keyword(s):

Real World ◽

Real World Data ◽

World Data ◽

Exenatide Qw

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His-bundle pacing in CHF-patients with narrow QRS and chronic AF – an upgrade from single-chamber to dual-chamber ICD

European Heart Journal ◽

10.1093/ehjci/ehaa946.1082 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

A Ciesielski ◽

A Slawuta ◽

A Zabek ◽

K Boczar ◽

B Malecka ◽

...

Keyword(s):

Atrial Fibrillation ◽

Clinical Status ◽

Chronic Atrial Fibrillation ◽

Dual Chamber ◽

Icd Implantation ◽

Single Chamber ◽

His Bundle ◽

His Bundle Pacing ◽

Short Period

Abstract A single-chamber ICD is a standard method for primary SCD prophylaxis. In patients with chronic atrial fibrillation it does not contribute to the regularization of heart rate, which is crucial for proper treatment. Moreover, to avoid the deleterious effect of right ventricular pacing only minority of the patients with single chamber ICD get the appropriate, recommended dose of beta-blockers. The aim of our study was to assess the efficacy of direct His-bundle pacing in a population of patients with congestive heart failure and chronic atrial fibrillation using upgrade from single chamber to dual-chamber ICD and atrial channel to perform the His-bundle pacing Methods The study population included 39 patients (37 men, 2 women) aged 67.2±9.3 years, with CHF and chronic AF implanted primarily with single chamber ICD with established pharmacotherapy and stable clinical status. Results The echocardiography measurements at baseline and during follow-up were presented in the table: During short period (3–6 months) of follow-up the mean values of EF and LV dimensions significantly improved. This was also accompanied by functional status improvement. Conclusions His-bundle-based pacing in CHF-chronic AF patients contributes to significant echocardiographic and clinical improvement. Standard single-chamber ICD implantation in CHF-chronic AF patients yields only SCD prevention without influence on remodeling process. The physiological pacing contributes to better pharmacotherapy. Funding Acknowledgement Type of funding source: None

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Direct Anticoagulants Versus Vitamin K Antagonists in Patients Aged 80 Years or Older With Atrial Fibrillation in a “Real-world” Nationwide Registry: Insights From the FANTASIIA Study

Journal of Cardiovascular Pharmacology and Therapeutics ◽

10.1177/1074248420916316 ◽

2020 ◽

Vol 25 (4) ◽

pp. 316-323

Author(s):

Martín Ruiz Ortiz ◽

Javier Muñiz ◽

María Asunción Esteve-Pastor ◽

Francisco Marín ◽

Inmaculada Roldán ◽

...

Keyword(s):

Atrial Fibrillation ◽

Vitamin K ◽

Real World ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Left Ventricular ◽

Anticoagulant Treatment ◽

Cancer History

Objective: To describe major events at follow up in octogenarian patients with atrial fibrillation (AF) according to anticoagulant treatment: direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs). Methods: A total of 578 anticoagulated patients aged ≥80 years with AF were included in a prospective, observational, multicenter study. Basal features, embolic events (stroke and systemic embolism), severe bleedings, and all-cause mortality at follow up were investigated according to the anticoagulant treatment received. Results: Mean age was 84.0 ± 3.4 years, 56% were women. Direct oral anticoagulants were prescribed to 123 (21.3%) patients. Compared with 455 (78.7%) patients treated with VKAs, those treated with DOACs presented a lower frequency of permanent AF (52.9% vs 61.6%, P = .01), cancer history (4.9% vs 10.9%, P = .046), renal failure (21.1% vs 32.2%, P = .02), and left ventricular dysfunction (2.4% vs 8.0%, P = .03); and higher frequency of previous stroke (26.0% vs 16.6%, P = .02) and previous major bleeding (8.1% vs 3.6%, P = .03). There were no significant differences in Charlson, CHA2DS2VASc, nor HAS-BLED scores. At 3-year follow up, rates of embolic events, severe bleedings, and all-cause death (per 100 patients-year) were similar in both groups (DOACs vs VKAs): 0.34 vs 1.35 ( P = .15), 3.45 vs 4.41 ( P = .48), and 8.2 vs 11.0 ( P = .18), respectively, without significant differences after multivariate analysis (hazard ratio [HR]: 0.25, 95% confidence interval [CI]: 0.03-1.93, P = .19; HR: 0.88, 95% CI: 0.44-1.76, P = .72 and HR: 0.84, 95% CI: 0.53-1.33, P = .46, respectively). Conclusion: In this “real-world” registry, the differences in major events rates in octogenarians with AF were not statistically significant in those treated with DOACs versus VKAs.

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“Unreal world” or “real world” data in oral anticoagulant treatment of atrial fibrillation

Thrombosis and Haemostasis ◽

10.1160/th16-08-0658 ◽

2016 ◽

Vol 116 (10) ◽

pp. 587-589 ◽

Cited By ~ 41

Author(s):

Gregory Y. H. Lip ◽

Ben Freedman

Keyword(s):

Atrial Fibrillation ◽

Real World ◽

Oral Anticoagulant ◽

Review Process ◽

Anticoagulant Treatment ◽

Real World Data ◽

Oral Anticoagulant Treatment ◽

World Data

Note: The review process for this manuscript was fully handled by Christian Weber, Editor in Chief.

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Long Term Real-World Outcomes of Trifluridine/Tipiracil in Metastatic Colorectal Cancer—A Single UK Centre Experience

Current Oncology ◽

10.3390/curroncol28030208 ◽

2021 ◽

Vol 28 (3) ◽

pp. 2260-2269

Author(s):

Daniel Tong ◽

Lei Wang ◽

Jeewaka Mendis ◽

Sharadah Essapen

Keyword(s):

Colorectal Cancer ◽

Metastatic Colorectal Cancer ◽

Real World ◽

Systemic Treatment ◽

Progression Free Survival ◽

Median Number ◽

Current Data ◽

Real World Data

In the UK, Trifluridine-tipiracil (Lonsurf) is used to treat metastatic colorectal cancer in the third-line setting, after prior exposure to fluoropyrimidine-based regimes. Current data on the real-world use of Lonsurf lack long-term follow-up data. A retrospective evaluation of patients receiving Lonsurf at our Cancer Centre in 2016–2017 was performed, all with a minimum of two-year follow-up. Fifty-six patients were included in the review. The median number of cycles of Lonsurf administered was 3. Median follow-up was 6.0 months, with all patients deceased at the time of analysis. Median progression-free survival (PFS) was 3.2 months, and overall survival (OS) was 5.8 months. The median interval from Lonsurf discontinuation to death was two months, but seven patients received further systemic treatment and median OS gained was 12 months. Lonsurf offered a slightly better PFS but inferior OS to that of the RECOURSE trial, with PFS similar to real-world data previously presented. Interestingly, 12.5% had a PFS > 9 months, and this cohort had primarily left-sided and RAS wild-type disease. A subset received further systemic treatment on Lonsurf discontinuation with good additional OS benefit. Lonsurf may alter the course of disease for a subset of patients, and further treatment on progression can be considered in carefully selected patients.

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Up to 6-year follow-up after pulmonary vein isolation for persistent/permanent atrial fibrillation: Importance of sinus node function

Journal of Thoracic and Cardiovascular Surgery ◽

10.1016/j.jtcvs.2010.04.045 ◽

2011 ◽

Vol 141 (6) ◽

pp. 1455-1460 ◽

Cited By ~ 3

Author(s):

Yoshiharu Soga ◽

Hitoshi Okabayashi ◽

Yoshio Arai ◽

Takuya Nomoto ◽

Jota Nakano ◽

...

Keyword(s):

Atrial Fibrillation ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Sinus Node ◽

Permanent Atrial Fibrillation

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Real world experience with coronary sinus reducer implantation for the treatment of refractory angina: a single-centre experience

European Heart Journal ◽

10.1093/eurheartj/ehab724.1203 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

J P Dias Ferreira Reis ◽

R Ramos ◽

P Rio ◽

A Fiarresga ◽

D Cacela ◽

...

Keyword(s):

Coronary Sinus ◽

Real World ◽

Therapeutic Option ◽

Objective Evaluation ◽

Short Version ◽

Refractory Angina ◽

Single Centre ◽

Real World Data ◽

Serious Adverse Events

Abstract Background Coronary sinus Reducer device (CSF) implantation is a novel therapeutic option to relieve symptoms in patients with refractory angina (RA). There is limited real-world data describing its use outside of clinical trials. Aim To assess the safety and efficacy of this procedure in a real-world setting. Methods This is a report of a single centre prospective registry of consecutive patients with RA (CCS II-IV) deemed unsuitable for revascularization. Between May 2017 and August 2019, 17 patients were referred to CSF implantation. Baseline and follow-up evaluation consisted of clinical assessment, including completion of the short version of the Seattle Angina Questionnaire (SAQ-7) and CCS class evaluation and objective evaluation by transthoracic echocardiography and cardiopulmonary exercise test (CPET). Results A total of 13 patients (70,6±6,5 years, 76,9% male) underwent CSF implantation with a procedural success of 84.6%. No cases of periprocedural serious adverse events were reported. At 12-month follow-up, any reduction in CCS Class was achieved in 72.7% of cases, with 27.2% reducing 2 CCS classes. Baseline CCS score was reduced from 2.8±0.4 to 1.7±0.8 (p=0.009). Quality of life (QoL) was significantly improved as assessed by the improvement seen in all items of SAQ-7 (p<0.017 for all). CPET duration was significantly increased (p=0.034), but no change was noted in the remainder CPET variables. During follow-up, 3 patients suffered myocardial infarction, resulting in 1 death. Conclusion CSF implantation in patients with RA was safe and led to a significant reduction of the angina burden and improvement of QoL at 12-month follow-up. FUNDunding Acknowledgement Type of funding sources: None.

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