Implantable Cardioverter-Defibrillators in Poland Compared with other European Countries from the Patient's Perspective: Insights from the EHRA Patient Survey.

BACKGROUND: The aim of this study was to compare differences between Polish ICD recipients and ICD recipients from other European countries in terms of quality of life, information provision before ICD implantation, and end-of-life issues. METHODS: This is a sub-analysis of the "Living with an ICD" patient survey (25-item questionnaire) organized by the European Heart Rhythm Association between 12 April 2021 and 5 July 2021 in ten European countries. RESULTS: There were 410 (22.7%) patients from Poland and 1399 (77.3%) from other European countries. A total of 51.0% of Polish patients reported improvement in their quality of life compared with 44.3% in other countries (p = 0.041). Remote monitoring was three times more often utilized in other countries than in Poland (66.8% vs. 21.0%, p < 0.001). While 78.1% of Poles felt well informed before ICD implantation compared with 69.6% of subjects from other countries (p = 0.001), they were less familiar with the ICD deactivation process than others (38.9% vs. 52.5%, p < 0.001). CONCLUSIONS: Despite the less frequent use of remote monitoring and gaps in end-of-life issues, Polish ICD recipients reported more favorable quality of life and a higher level of information received before device placement than patients in other European countries.

Mexiletine for recurrent ventricular tachycardia in adult patients with structural heart disease and implantable cardioverter defibrillator: an EHRA systematic review.

The aim of the study was to systematically review evidence on the effectiveness and safety of oral mexiletine administered in monotherapy or in combination with other antiarrhythmic drugs for recurrent ventricular arrhythmia (ventricular tachycardia/ventricular fibrillation, VT/VF) in adult patients with structural heart disease (SHD) and implantable cardioverter defibrillators (ICDs). We systematically searched MEDLINE, Embase, and CENTRAL databases from inception to 27 August 2021 for prospective and retrospective studies investigating mexiletine in the target population. The main outcome was the reduction of ICD therapy. The main safety outcome was the presence of any serious adverse events (SAEs) leading to mexiletine discontinuation. Study quality was assessed using the Cochrane risk of bias tool or the Newcastle-Ottawa scale. Four studies comprising 86 mexiletine recipients were included in the review. We also obtained individual data of 50 patients from two studies. Ischaemic cardiomyopathy (ICM) was present in 86% of patients. The quality of included studies was moderate/low. A narrative review was undertaken as studies varied widely in terms of study population and treatment. Across studies, mexiletine treatment (with or without amiodarone) seemed to consistently reduce the number of ICD therapies especially in a population where catheter ablation (CA) was unsuccessful or contraindicated. In ICM patients deemed eligible for CA, mexiletine seemed to be inferior to CA. Mexiletine was discontinued in 14% of cases, mainly for gastrointestinal or neurological SAE. Mexiletine seems to be an option for the long-term treatment of recurrent VT/VF in adult patients with SHD, especially ICM, and ICD in whom CA was unsuccessful or not suitable.

Effectiveness and safety of a single freeze strategy of cryoballoon ablation of atrial fibrillation: an EHRA systematic review and meta-analysis.

To conduct a systematic review and meta-analysis to compare the effectiveness and safety of cryoballoon ablation of atrial fibrillation (AF) performed using a single freeze strategy in comparison to an empiric double ('bonus') freeze strategy. We systematically searched MEDLINE, EMBASE, and CENTRAL databases from inception to 12 July 2020, for prospective and retrospective studies of patients undergoing cryoballoon for paroxysmal or persistent AF comparing a single vs. bonus freeze strategy. The main outcome was atrial arrhythmia-free survival and eligible studies required at least 12 months of follow-up; the primary safety outcome was a composite of all complications. Study quality was assessed using the Cochrane risk of bias tool and the Newcastle-Ottawa Scale. Thirteen studies (3 randomized controlled trials and 10 observational studies) comprising 3163 patients were eligible for inclusion (64% males, 71.5% paroxysmal AF, mean CHA2DS2-VASc score 1.3 ± 0.9). There was no significant difference in pooled effectiveness between single freeze strategy compared to double freeze strategy [relative risk (RR) 1.03; 95% confidence interval (CI): 0.98-1.07; I2 = 0%]. Single freeze procedures were associated with a significantly lower adverse event rate (RR 0.72; 95% CI: 0.53-0.98; I2 = 0%) and shorter average procedure time (90 ± 27 min vs. 121 ± 36 min, P < 0.001). A trend for lower risk of persistent phrenic nerve palsy was observed (RR 0.61; 95% CI: 0.37-1.01; I2 = 0%). The quality of included studies was moderate/good, with no evidence of significant publication bias. Single freeze strategy for cryoballoon of AF is as effective as an empiric double ('bonus') freeze strategy while appearing safer and probably quicker (PROSPERO registration number CRD42020158696).

New diagnostic pathways urgently needed. Protocol of PET Guidance I pilot study: positron emission tomography in suspected cardiac implantable electronic device-related infection.

BACKGROUND: Cardiovascular implantable electronic device (CIED) infection is a complication of increasing incidence. We present a protocol of an observational case control clinical trial "Positron Emission Tomography Combined With Computed Tomography (PET CT) in Suspected Cardiac Implantable Electronic Device Infection, a Pilot Study - PET Guidance I" (NCT02196753). AIM: The aim of this observational clinical trial is to assess and standardise diagnostic algorithms for CIED infections (lead-dependent infective endocarditis, generator pocket infection, fever of unknown origin) with PET CT in Poland. METHODS AND RESULTS: Study group will consist of 20 patients with initial diagnosis of CIED-related infection paired with a control group of 20 patients with implanted CIEDs, who underwent PET CT due to other non-infectious indications and have no data for infectious process in follow-up. All patients included in the study will undergo standard diagnostic pro-cess. Conventional/standard diagnostic and therapeutic process will consist of: medical interview, physical examination, laboratory tests, blood cultures; imaging studies: echocardiography: transthoracic (TTE), and, if there are no contraindications transoesophageal, computed tomography scan for pulmonary embolism if indicated; if there are abnormalities in other systems, decisions concerning further diagnostics will be made at the physician's discretion. As well as standard diagnostic procedures, patients will undergo whole body PET CT scan to localise infection or inflammation. Diagnosis and therapeutic decision will be obtained from the Study Committee. Follow-up will be held within six months with control visits at three and six months. During each follow-up visit, all patients will undergo laboratory tests, two blood cultures collected 1 h apart, and TTE. In case of actual clinical suspicion of infective endocarditis or local generator pocket infection, patients will be referred for further diagnostics. Endpoints for the results assessment - primary endpoints are to standardise PET CT in the diagnostic process: sensitivity, specificity, positive predictive value, and negative predictive value of the diagnosis made by PET CT; secondary endpoints are: assessment of usefulness of PET CT for detection of remote infective complications (metastatic abscesses, infected pulmonary emboli), incidence of particular localisations of infection, influence of PET CT on therapeutic decision: confirmation or change of decision based on PET CT, safety and complications of diagnostic process of CIED-related infections with PET CT. CONCLUSIONS: Evaluation of PET CT use for device-related infections in a case control study may be conclusive and improve diagnostic pathway.

Gender-related differences in outcomes and resource utilization in patients undergoing radiofrequency ablation of supraventricular tachycardia: results from Patients' Perspective on Radiofrequency Catheter Ablation of AVRT and AVNRT Study.

AIMS: The aim of this study was to describe gender-related differences in clinical presentation, radiofrequency ablation (RFA) outcomes, and healthcare resource utilization in a group of patients with atrioventricular nodal reciprocating tachycardia (AVNRT) and atrioventricular reciprocating tachycardia (AVRT). METHODS AND RESULTS: This was a single-centre, prospective, cohort study which enroled 82 patients undergoing RFA of AVNRT or AVRT. At baseline, all patients received a clinical assessment and completed questionnaires concerning: socioeconomic status, disease-specific symptoms (Patient Perception of Arrhythmia Questionnaire; PPAQ), health-related quality of life (HRQoL) (EQ-5D-3L), and healthcare resource utilization. Two months after RFA, the clinical assessment was repeated and subjects completed PPAQ and EQ-5D-3L. Follow-up was completed by 64 patients, 41 (64%) women. At baseline, there were no significant differences in baseline characteristics, except AVNRT prevalence, and HRQoL by gender but women reported higher severity of symptoms on PPAQ than men (2.8 vs. 2.4 points, P < 0.001). At 2 months after RFA, women still reported higher severity of symptoms (1.8 vs. 0 points; P = 0.02) on PPAQ and more heart skipping than men (54 vs. 13%; P = 0.0014); differences in EQ-5D-3L index and EQ-VAS were insignificant. There was no significant difference in healthcare resource utilization during the year preceding RFA, but antiarrhythmic drugs were significantly more often prescribed to women pre-procedure (30 vs. 8%; P = 0.022). CONCLUSION: There is a small but significant gender-related difference in outcome of RFA in patients with AVNRT or AVRT measured with a disease-specific instrument. No significant difference in HRQoL or access to healthcare resources between women and men was found.

Translation and cultural adaptation of a Patient Perception of Arrhythmia Questionnaire in Poland.

BACKGROUND: The Patient Perception of Arrhythmia Questionnaire (PPAQ) is a disease-specific questionnaire designed to measure symptoms and health-related quality of life in patients suffering from a group of arrhythmias collectively known as supraventricular tachycardias (SVT). There is no valid translation of PPAQ available in Poland, which hinders research in this area with Polish arrhythmia patients. AIM: To conduct initial content validity testing through translation and cultural adaptation of the English language version of the PPAQ to the Polish language. METHODS: The whole project was conducted according to the ISPOR Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures published in 2005. RESULTS: In 2011, the PPAQ was translated into Polish and cultural adaptation was performed on 20 patients with SVT (12 male, age 54.9 ± 17.4). Issues concerning the exact meanings of symptom names and language-dependant gender-related distinctions were identified. The former was solved by cooperation with experts in arrhythmia, and the latter by incorporating patients' preferences during cognitive debriefing. CONCLUSIONS: The Polish translation was well accepted by patients during this translation and initial content validity testing. Issues arising during the translation process may recur in other translations and be resolved in a similar manner.

Radiofrequency ablation of numerous premature ventricular contractions in a cardiac resynchronisation therapy patient: a long-term follow-up.

We present a case study of a patient with dilated cardiomyopathy and a cardiac resynchronisation therapy (CRT) device who was repeatedly hospitalised due to heart failure (HF) exacerbations. A successful radiofrequency ablation of numerous premature ventricular contractions enabled the proper action of CRT and stabilised the patient's condition in NYHA II without HF subsequent hospitalisations during a 30 month follow-up.