scholarly journals 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

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.

scholarly journals POSTERS (2)96CONTINUOUS VERSUS INTERMITTENT MONITORING FOR DETECTION OF SUBCLINICAL ATRIAL FIBRILLATION IN HIGH-RISK PATIENTS97HIGH DAY-TO-DAY INTRA-INDIVIDUAL REPRODUCIBILITY OF THE HEART RATE RESPONSE TO EXERCISE IN THE UK BIOBANK DATA98USE OF NOVEL GLOBAL ULTRASOUND IMAGING AND CONTINUEOUS DIPOLE DENSITY MAPPING TO GUIDE ABLATION IN MACRO-REENTRANT TACHYCARDIAS99ANTICOAGULATION AND THE RISK OF COMPLICATIONS IN PATIENTS UNDERGOING VT AND PVC ABLATION100NON-SUSTAINED VENTRICULAR TACHYCARDIA FREQUENTLY PRECEDES CARDIAC ARREST IN PATIENTS WITH BRUGADA SYNDROME101USING HIGH PRECISION HAEMODYNAMIC MEASUREMENTS TO ASSESS DIFFERENCES IN AV OPTIMUM BETWEEN DIFFERENT LEFT VENTRICULAR LEAD POSITIONS IN BIVENTRICULAR PACING102CAN WE PREDICT MEDIUM TERM MORTALITY FROM TRANSVENOUS LEAD EXTRACTION PRE-OPERATIVELY?103PREVENTION OF UNECESSARY ADMISSIONS IN ATRIAL FIBRILLATION104EPICARDIAL CATHETER ABLATION FOR VENTRICULAR TACHYCARDIA ON UNINTERRUPTED WARFARIN: A SAFE APPROACH?105HOW WELL DOES THE NATIONAL INSTITUTE OF CLINICAL EXCELLENCE (NICE) GUIDENCE ON TRANSIENT LOSS OF CONSCIOUSNESS (T-LoC) WORK IN A REAL WORLD? AN AUDIT OF THE SECOND STAGE SPECIALIST CARDIOVASCULAT ASSESSMENT AND DIAGNOSIS106DETECTION OF ATRIAL FIBRILLATION IN COMMUNITY LOCATIONS USING NOVEL TECHNOLOGY'S AS A METHOD OF STROKE PREVENTION IN THE OVER 65'S ASYMPTOMATIC POPULATION - SHOULD IT BECOME STANDARD PRACTISE?107HIGH-DOSE ISOPRENALINE INFUSION AS A METHOD OF INDUCTION OF ATRIAL FIBRILLATION: A MULTI-CENTRE, PLACEBO CONTROLLED CLINICAL TRIAL IN PATIENTS WITH VARYING ARRHYTHMIC RISK108PACEMAKER COMPLICATIONS IN A DISTRICT GENERAL HOSPITAL109CARDIAC RESYNCHRONISATION THERAPY: A TRADE-OFF BETWEEN LEFT VENTRICULAR VOLTAGE OUTPUT AND EJECTION FRACTION?110RAPID DETERIORATION IN LEFT VENTRICULAR FUNCTION AND ACUTE HEART FAILURE AFTER DUAL CHAMBER PACEMAKER INSERTION WITH RESOLUTION FOLLOWING BIVENTRICULAR PACING111LOCALLY PERSONALISED ATRIAL ELECTROPHYSIOLOGY MODELS FROM PENTARAY CATHETER MEASUREMENTS112EVALUATION OF SUBCUTANEOUS ICD VERSUS TRANSVENOUS ICD- A PROPENSITY MATCHED COST-EFFICACY ANALYSIS OF COMPLICATIONS & OUTCOMES113LOCALISING DRIVERS USING ORGANISATIONAL INDEX IN CONTACT MAPPING OF HUMAN PERSISTENT ATRIAL FIBRILLATION114RISK FACTORS FOR SUDDEN CARDIAC DEATH IN PAEDIATRIC HYPERTROPHIC CARDIOMYOPATHY: A SYSTEMATIC REVIEW AND META-ANALYSIS115EFFECT OF CATHETER STABILITY AND CONTACT FORCE ON VISITAG DENSITY DURING PULMONARY VEIN ISOLATION116HEPATIC CAPSULE ENHANCEMENT IS COMMONLY SEEN DURING MR-GUIDED ABLATION OF ATRIAL FLUTTER: A MECHANISTIC INSIGHT INTO PROCEDURAL PAIN117DOES HIGHER CONTACT FORCE IMPAIR LESION FORMATION AT THE CAVOTRICUSPID ISTHMUS? INSIGHTS FROM MR-GUIDED ABLATION OF ATRIAL FLUTTER118CLINICAL CHARACTERISATION OF A MALIGNANT SCN5A MUTATION IN CHILDHOOD119RADIOFREQUENCY ASSOCIATED VENTRICULAR FIBRILLATION120CONTRACTILE RESERVE EXPRESSED AS SYSTOLIC VELOCITY DOES NOT PREDICT RESPONSE TO CRT121DAY-CASE DEVICES - A RETROSPECTIVE STUDY USING PATIENT CODING DATA122PATIENTS UNDERGOING SVT ABLATION HAVE A HIGH INCIDENCE OF SECONDARY ARRHYTHMIA ON FOLLOW UP: IMPLICATIONS FOR PRE-PROCEDURE COUNSELLING123PROGNOSTIC ROLE OF HAEMOGLOBINN AND RED BLOOD CELL DITRIBUTION WIDTH IN PATIENTS WITH HEART FAILURE UNDERGOING CARDIAC RESYNCHRONIZATION THERAPY124REMOTE MONITORING AND FOLLOW UP DEVICES125A 20-YEAR, SINGLE-CENTRE EXPERIENCE OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) IN CHILDREN: TIME TO CONSIDER THE SUBCUTANEOUS ICD?126EXPERIENCE OF MAGNETIC REASONANCE IMAGING (MEI) IN PATIENTS WITH MRI CONDITIONAL DEVICES127THE SINUS BRADYCARDIA SEEN IN ATHLETES IS NOT CAUSED BY ENHANCED VAGAL TONE BUT INSTEAD REFLECTS INTRINSIC CHANGES IN THE SINUS NODE REVEALED BY I (F) BLOCKADE128SUCCESSFUL DAY-CASE PACEMAKER IMPLANTATION - AN EIGHT YEAR SINGLE-CENTRE EXPERIENCE129LEFT VENTRICULAR INDEX MASS ASSOCIATED WITH ESC HYPERTROPHIC CARDIOMYOPATHY RISK SCORE IN PATIENTS WITH ICDs: A TERTIARY CENTRE HCM REGISTRY130A DGH EXPERIENCE OF DAY-CASE CARDIAC PACEMAKER IMPLANTATION131IS PRE-PROCEDURAL FASTING A NECESSITY FOR SAFE PACEMAKER IMPLANTATION?

EP Europace ◽  
2016 ◽  
Vol 18 (suppl 2) ◽  
pp. ii36-ii47
Author(s):  
T. Philippsen ◽  
M. Orini ◽  
C.A. Martin ◽  
E. Volkova ◽  
J.O.M. Ormerod ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Ventricular Tachycardia ◽  
Hypertrophic Cardiomyopathy ◽  
Pacemaker Implantation ◽  
Left Ventricular ◽  
Day Case ◽  
Single Centre ◽  
Subcutaneous Icd

scholarly journals 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

2019 ◽  
Vol 27 (12) ◽  
pp. 605-612 ◽  
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.

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

2022 ◽  
Vol 8 ◽  
Author(s):  
Vincenzo Russo ◽  
Antonello D'Andrea ◽  
Stefano De Vivo ◽  
Anna Rago ◽  
Gianluca Manzo ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Real World ◽  
Clinical Performance ◽  
Perioperative Complications ◽  
Sinus Node ◽  
Cardiac Pacemaker ◽  
Real World Data ◽  
Single Chamber ◽  
Pacemaker Syndrome

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.

P1024Catheter ablation is associated with reduced all-cause mortality in a real-world cohort of patients with atrial fibrillation and heart failure

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Samuel ◽  
M Abrahamowicz ◽  
J Joza ◽  
V Essebag ◽  
L Pilote
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Real World ◽  
Population Based ◽  
World Population ◽  
Risk Of Death ◽  
All Cause Mortality

Abstract Background Atrial fibrillation (AF) and heart failure (HF) are common co-existing conditions. Randomized trial data suggests a reduction in all-cause mortality with catheter ablation (CA) in selected patients, however, whether these results are replicable in a real-world population and persist in the long-term remains to be shown. Purpose To evaluate the long-term effectiveness of CA in AF-HF patients in reducing the incidence of: a) all-cause mortality b) HF hospitalizations, and c) major morbidities (stroke/transient ischemic attack (TIA) and major bleeding). Methods A population-based administrative cohort was created of AF-HF patients with government prescription coverage in Quebec, Canada (1999–2015). Patients who underwent CA (cases) were matched 1:2 to controls using risk-set sampling. Cases were matched on time in the cohort and frequency of hospitalizations. Measured time-invariant confounders were controlled for using inverse probability of treatment weighting (IPTW) and included age, sex, clinical characteristics, presence of cardiac implantable electronic devices, and medication use. Multivariable Cox models adjusted the association of CA with the outcomes for the time varying confounders of the presence of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT), anticoagulation use (warfarin or direct oral anticoagulation), and any antiarrhythmic (AAD) use during follow-up. For non-fatal outcomes, the competing risk of death was accounted for using the Lunn-McNeil approach. Results Of the 87,676 AF-HF patients, 298 underwent CA and were matched to 591 controls. After IPTW, the distribution of covariates was balanced between cases and controls [age 65.6±11.0 vs 61.6±11.6; women 24% vs 20%; CHA2DS2-Vasc score 3.2±2.3 vs 2.9±2.1; CA vs non-CA, respectively; standardized mean differences <0.1 for all]. Over a median follow-up of 3.3 (IQR 1.1–6.4) years, 19 (7.3%) of CA patients died compared to 144 (24.6%) non-CA patients. After weighting and adjustment, CA was associated with a statistically significant reduction in the incidence of all-cause mortality [adjusted HR 0.5 (95% CI 0.3–0.9)]. In addition, there was no statistically significant difference in the incidence of HF hospitalizations over the follow-up [CA: 22.5% vs non-CA: 27.1%; adjusted HR 0.9 (95% CI 0.6–1.2)]. The incidences of stroke/TIA (1.7% vs 6.8%) and major bleeding (1.7% vs 4.9%) for CA vs non-CA were not statistically different. Conclusion In a matched population-based AF-HF cohort, CA was associated with a reduced risk of all-cause mortality compared to patients who did not undergo CA. Although no difference in the risk of HF hospitalizations, stroke/TIA, and major bleeding was detected between CA and non-CA patients, larger studies are warranted. Acknowledgement/Funding Canadian Institute of Health Research; Fonds de recherché du Quebec-Santé, Clinical Research Scholar Award (V. Essebag) and Doctoral Award (M. Samuel)

scholarly journals Risk Stratification for Atrial Fibrillation and Outcomes in Tachycardia-Bradycardia Syndrome: Ablation vs. Pacing

2021 ◽  
Vol 8 ◽  
Author(s):  
Rongfeng Zhang ◽  
Yue Wang ◽  
Minghui Yang ◽  
Yiheng Yang ◽  
Zhengyan Wang ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Risk Stratification ◽  
Primary Endpoint ◽  
Pacemaker Implantation ◽  
Persistent Atrial Fibrillation ◽  
Nyha Classification

Background: Catheter ablation of atrial fibrillation is an alternative treatment for patients with tachycardia-bradycardia syndrome (TBS) to avoid pacemaker implantation. The risk stratification for atrial fibrillation and outcomes between ablation and pacing has not been fully evaluated.Methods: This retrospective study involved 306 TBS patients, including 141 patients who received catheter ablation (Ablation group, age: 62.2 ± 9.0 months, mean longest pauses: 5.2 ± 2.2 s) and 165 patients who received pacemaker implement (Pacing group, age: 62.3 ± 9.1 months, mean longest pauses: 6.0 ± 2.3 s). The primary endpoint was a composite of call cause mortality, cardiovascular-related hospitalization or thrombosis events (stroke, or peripheral thrombosis). The second endpoint was progress of atrial fibrillation and heart failure.Results: After a median follow-up of 75.4 months, the primary endpoint occurred in significantly higher patients in the pacing group than in the ablation group (59.4 vs.15.6%, OR 6.05, 95% CI: 3.73–9.80, P &lt; 0.001). None of deaths was occurred in ablation group, and 1 death occurred due to cancer. Cardiovascular-related hospitalization occurred in 50.9% of the pacing group compared with 14.2% in the ablation group (OR: 4.87, 95% CI: 2.99–7.95, P &lt; 0.001). More thrombosis events occurred in the pacing group than in the ablation group (12.7 vs. 2.1%, OR 6.06, 95% CI: 1.81–20.35, P = 0.004). Significant more patients progressed to persistent atrial fibrillation in pacing group than in ablation group (23.6 vs. 2.1%, P &lt; 0.001). The NYHA classification of the pacing group was significantly higher than that of the ablation group (2.11 ± 0.83 vs. 1.50 ± 0.74, P &lt; 0.001). The proportion of antiarrhythmic drugs and anticoagulants used in the pacing group was significantly higher than that in the ablation group (41.2 vs. 7.1%, P &lt; 0.001; 16.4 vs. 2.1%, P = 0.009).Conclusion: Catheter ablation for patients with TBS was associated with a significantly lower rate of a composite end point of cardiovascular related hospitalization and thromboembolic events. Furthermore, catheter ablation reduced the progression of atrial fibrillation and heart failure.

scholarly journals 2MACE score predicts cardiovascular adverse events in real-world atrial fibrillation patients under rivaroxaban therapy. Data from EMIR study

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
M Esteve Pastor ◽  
F Marin ◽  
M Anguita ◽  
M Sanmartin ◽  
C Rafols ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
High Risk ◽  
Adverse Events ◽  
Cardiovascular Mortality ◽  
Real World ◽  
Cardiovascular Events ◽  
Major Adverse Cardiovascular Events

Abstract Background Atrial Fibrillation (AF) patients have higher risk of major adverse cardiovascular events (MACEs). In 2015, the 2MACE score (2 points for metabolic syndrome and age ≥75, and 1 point for myocardial infarction [MI] or revascularization, congestive heart failure [ejection fraction ≤40%] and thromboembolism [stroke or transient ischemic attack]) was described to stratify cardiovascular risk and 2MACE≥3 was related with high risk of MACE in AF patients but a long-term validation in prospective patients under direct anticoagulants has not been performed yet. The aim of this study was to analyse the incidence of cardiovascular events and to validate the 2MACE score as predictor of MACEs. Methods EMIR study [acronym from 'Estudio observacional para la identificaciόn de los factores de riesgo asociados a eventos cardiovasculares Mayores en pacientes con fIbrilaciόn auricular no valvular tratados con un anticoagulante oral directo (Rivaroxaban)'] was an observational, multicenter, post-authorization and prospective study that involved AF patients under oral anticoagulation with rivaroxaban at least 6 months before enrolment. We analyzed baseline clinical characteristics and adverse events after 2.5 years of follow up: annual incidence of thromboembolic events, MACE (composite of nonfatal MI, coronary revascularization and cardiac death) and cardiovascular mortality were analyzed. Results We analyzed 1,433 patients (55.5% women, mean 74.2±9.7 years). 385 (26.9%) patients had 2MACE score ≥3 and of those high-risk patients, 42.1% had previous coronary disease, 12.5% had previous peripheral artery disease, 40.7% had diabetes mellitus, 39% heart failure and 50% had chronic kidney disease (GFR&lt;60 ml/min). After 2.5 (2.2–2.6) years of follow-up, we observed patients with 2MACE score ≥3 had higher rate of adverse events (Table), specially of higher rate of cardiovascular mortality and MACE. Patients with 2MACE score ≥3 had RR 4.09 (2.59–6.45; p&lt;0.001) for MACE. Indeed, patients with 2MACE score ≥3 had around 6-fold risk of cardiovascular death due heart failure than patients with 2MACE score &lt;3 (0.17%/year vs 1.09%/year; p=0.003). 2MACE score had suitable predictive performance for MACE (AUC 0.638 [(0.534–0.742); p=0.010). Conclusion In a Real-world AF patients under rivaroxaban therapy from EMIR registry, the 2MACE score is a good predictor of long-term cardiovascular events, MACE and major bleeding. A 2MACE score ≥3 categorize patients at “high-risk” with almost 4-fold risk of MACE in a long-term follow-up. FUNDunding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Bayer Hispania S.L. Table 1. Adverse events according to 2MACE

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

EP Europace ◽  
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

scholarly journals Ablation of paroxysmal and persistent atrial fibrillation in the very elderly real‐world data on safety and efficacy

2020 ◽  
Vol 43 (12) ◽  
pp. 1579-1584
Author(s):  
Kevin Willy ◽  
Kristina Wasmer ◽  
Dirk G. Dechering ◽  
Julia Köbe ◽  
Philipp S. Lange ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Real World ◽  
Persistent Atrial Fibrillation ◽  
Very Elderly ◽  
Real World Data ◽  
Safety And Efficacy ◽  
World Data

P0187COMPARING OPAL-HK DATA TO REAL-WORLD DATA FROM THE UNITED KINGDOM: HOW EFFECTIVE IS PATIROMER AT ACHIEVING NORMOKALAEMIA?

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Ibrahim Ali ◽  
Georgiana Cornea ◽  
Michele Intorcia ◽  
Philip A Kalra
Keyword(s):  
Heart Failure ◽  
Real World ◽  
Serum Potassium ◽  
Potassium Level ◽  
Matched Cohort ◽  
Real World Data ◽  
World Data ◽  
The United Kingdom ◽  
The Mean

Abstract Background and Aims The first phase of the published OPAL-HK study showed that Patiromer, an oral potassium binder, was effective at reducing serum potassium levels in patients with chronic kidney disease (CKD) stages 3 to 4. This phase was a 4-week, single-group treatment phase. Given the lack of a control arm, the aim of our study was to use real-world data from a large CKD cohort to provide a control comparison to evaluate the efficacy of Patiromer in normalising serum potassium. Method The initial phase of OPAL-HK comprised 243 patients with CKD G3-4 with a baseline serum potassium of 5.1 to &lt;6.5mmol/L. To acquire a comparative matched cohort, patients were selected from the Salford Kidney Study (SKS), a prospective observational cohort study in the United Kingdom that has been recruiting patients aged ≥18 years old with CKD G3-5 since 2002. A 3-step process was applied to generate a propensity matched cohort. First, patients were chosen if they had an outpatient potassium level at any point after recruitment into SKS between 5.1mmol/L to &lt;6.5mmol/L and whose next outpatient potassium level was checked 24 to 42 days (3.5 to 6 weeks) later (n=755). Second, all key OPAL-HK inclusion and exclusion criteria were applied. This left 162 patients who were then accurately matched in a 1:1 fashion to the 243 OPAL-HK patients using propensity score matching based on 6 baseline variables: age, gender, eGFR, diabetes mellitus, heart failure and potassium level. This produced a cohort of 87 SKS patients matched to their 87 OPAL-HK partner patients. We compared the two patient groups for the following OPAL-HK study endpoints: the mean change in serum potassium from baseline to follow-up at week 4, and the proportion of patients with a serum potassium of 3.8 to &lt;5.1mmol/L at week 4. Results The groups were extremely well matched: between SKS vs. OPAL-HK, the mean (±SD) age was 63.9±13.3 vs. 63.7±9.5years (p=0.93); mean eGFR was 30.9±11.6 vs. 31.2±11.7ml/min/1.73m2 (p=0.85); 45 vs. 46 patients were diabetics (p=0.88); 29 vs. 24 had heart failure (p=0.41) and the mean potassium was 5.5±0.3mmol/L in both groups (p=0.68). The follow-up in the SKS cohort was 31±5 days. At the end of follow-up, the mean potassium level remained 5.5±0.3mmol/L in SKS patients but had reduced to 4.5±0.5mmol/L in the OPAL-HK group (p&lt;0.001), a mean (±SE) change of -1.00±0.06mmol/L. For the secondary endpoint, 74% of patients in OPAL-HK reached the target potassium range of 3.8 to &lt;5.1mmol/L at week 4 compared with 0% from the comparator SKS cohort (see Figure). Conclusion Using real-world data as a tightly-matched control arm for the first phase of the OPAL-HK study, Patiromer is shown to be effective at reducing potassium levels in patients with CKD G3-4.

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