Benefits of upgrading right ventricular to biventricular pacing in heart failure patients with atrial fibrillation.

BACKGROUND AND AIMS: Recommendations on Cardiac Resynchronization Therapy (CRT) in patients with atrial fibrillation or flutter (AF) are based on less robust evidence than those in sinus rhythm. We aimed to assess the efficacy of CRT upgrade in the BUDAPEST-CRT Upgrade trial population by their baseline rhythm. METHODS: Heart Failure patients with reduced ejection fraction (HFrEF) and priorly implanted pacemaker (PM) or implantable cardioverter defibrillator (ICD) and ≥20% right ventricular (RV) pacing burden were randomized to CRT-D upgrade (n=215) or ICD (n=145). Primary- [HF hospitalization (HFH), all-cause mortality, or <15% reduction of left ventricular end-systolic volume] and secondary outcomes were investigated. RESULTS: At enrolment 131 (36%) patients had AF, who had an increased risk for HFH as compared to those with sinus rhythm (SR) [adjusted hazard ratio (aHR) 2.99; 95%CI 1.26-7.13; P=0.013]. The effect of CRT-D upgrade was similar in patients with AF as in those with SR [AF adjusted odds ratio (aOR) 0.06; 95%CI 0.02 to 0.17; P<0.001; SR aOR 0.13; 95%CI 0.07 to 0.27; P<0.001; interaction P=0.29] during the mean follow-up time of 12.4 months. Also it decreased the risk of HFH or all-cause mortality (aHR 0.33; 95%CI 0.16 to 0.70; P=0.003; interaction P=0.17) and improved the echocardiographic response (left ventricular end-diastolic volume difference -49.21mL; 95%CI -69.10 to -29.32; P<0.001; interaction P=0.21). CONCLUSION: In HFrEF patients with AF and PM/ICD with high RV pacing burden, CRT-D upgrade decreased the risk of HFH and improved reverse remodeling when compared to ICD, similar to that seen in patients in SR.

Sodium Zirconium Cyclosilicate in HFrEF and Hyperkalemia: REALIZE-K Design and Baseline Characteristics.

BACKGROUND: Mineralocorticoid receptor antagonists (MRAs) improve outcomes in patients with heart failure and reduced ejection fraction (HFrEF). However, MRAs are often underused because of hyperkalemia concerns. OBJECTIVES: The purpose of this study was to assess whether sodium zirconium cyclosilicate (SZC), a nonabsorbed crystal that traps and rapidly lowers potassium, enables MRA use in patients with HFrEF and prevalent hyperkalemia (or at high risk). METHODS: REALIZE-K is a prospective, double-blind, placebo-controlled trial in patients with HFrEF (NYHA functional class II-IV; left ventricular ejection fraction ≤40%), optimal therapy (except MRA), and prevalent hyperkalemia (or at high risk). During the open-label run-in, all participants underwent protocol-mandated spironolactone titration (target: 50 mg daily); those with prevalent (cohort 1) or incident (cohort 2) hyperkalemia during titration started SZC. Participants achieving normokalemia while on spironolactone ≥25 mg daily were randomized to continuing SZC or matching placebo for 6 months. The primary composite endpoint was proportion of participants with optimal response (normokalemia, on spironolactone ≥25 mg daily, no rescue for hyperkalemia [months 1-6]). RESULTS: Of 365 patients (run-in), 202 were randomized. Baseline characteristics included mean age 70 years, prevalent comorbidities (78% estimated glomerular filtration rate <60 mL/min/1.73 m2, 38% atrial fibrillation/flutter), high N-terminal pro B-type natriuretic peptide (median 1,136 pg/mL), and high HFrEF therapy use (64% sacubitril/valsartan, 96% beta-blocker, 42% sodium glucose co-transporter 2 inhibitor). At randomization, 78% were receiving spironolactone 50 mg daily. CONCLUSIONS: REALIZE-K is the first trial to evaluate whether SZC can enable rapid and safe MRA optimization and long-term continuation in patients with HFrEF and prevalent/high risk of hyperkalemia. (Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients with Symptomatic HFrEF Receiving Spironolactone; NCT04676646).

Upgrade of right ventricular pacing to cardiac resynchronization therapy in heart failure: a randomized trial.

BACKGROUND AND AIMS: De novo implanted cardiac resynchronization therapy with defibrillator (CRT-D) reduces the risk of morbidity and mortality in patients with left bundle branch block, heart failure and reduced ejection fraction (HFrEF). However, among HFrEF patients with right ventricular pacing (RVP), the efficacy of CRT-D upgrade is uncertain. METHODS: In this multicentre, randomized, controlled trial, 360 symptomatic (New York Heart Association Classes II-IVa) HFrEF patients with a pacemaker or implantable cardioverter defibrillator (ICD), high RVP burden ≥ 20%, and a wide paced QRS complex duration ≥ 150 ms were randomly assigned to receive CRT-D upgrade (n = 215) or ICD (n = 145) in a 3:2 ratio. The primary outcome was the composite of all-cause mortality, heart failure hospitalization, or <15% reduction of left ventricular end-systolic volume assessed at 12 months. Secondary outcomes included all-cause mortality or heart failure hospitalization. RESULTS: Over a median follow-up of 12.4 months, the primary outcome occurred in 58/179 (32.4%) in the CRT-D arm vs. 101/128 (78.9%) in the ICD arm (odds ratio 0.11; 95% confidence interval 0.06-0.19; P < .001). All-cause mortality or heart failure hospitalization occurred in 22/215 (10%) in the CRT-D arm vs. 46/145 (32%) in the ICD arm (hazard ratio 0.27; 95% confidence interval 0.16-0.47; P < .001). The incidence of procedure- or device-related complications was similar between the two arms [CRT-D group 25/211 (12.3%) vs. ICD group 11/142 (7.8%)]. CONCLUSIONS: In pacemaker or ICD patients with significant RVP burden and reduced ejection fraction, upgrade to CRT-D compared with ICD therapy reduced the combined risk of all-cause mortality, heart failure hospitalization, or absence of reverse remodelling.

Ability to remotely monitor atrial high-rate episodes using a single-chamber implantable cardioverter-defibrillator with a floating atrial sensing dipole.

AIMS: To allow timely initiation of anticoagulation therapy for the prevention of stroke, the European guidelines on atrial fibrillation (AF) recommend remote monitoring (RM) of device-detected atrial high-rate episodes (AHREs) and progression of arrhythmia duration along pre-specified strata (6 min…<1 h, 1 h…<24 h, ≥ 24 h). We used the MATRIX registry data to assess the capability of a single-lead implantable cardioverter-defibrillator (ICD) with atrial sensing dipole (DX ICD system) to follow this recommendation in patients with standard indication for single-chamber ICD. METHODS AND RESULTS: In 1841 DX ICD patients with daily automatic RM transmissions, electrograms of first device-detected AHREs per patient in each duration stratum were adjudicated, and the corresponding positive predictive values (PPVs) for the detections to be true atrial arrhythmia were calculated. Moreover, the incidence and progression of new-onset AF was assessed in 1451 patients with no AF history. A total of 610 AHREs ≥6 min were adjudicated. The PPV was 95.1% (271 of 285) for episodes 6min…<1 h, 99.6% (253/254) for episodes 1 h…<24 h, 100% (71/71) for episodes ≥24 h, or 97.5% for all episodes (595/610). The incidence of new-onset AF was 8.2% (119/1451), and in 31.1% of them (37/119), new-onset AF progressed to a higher duration stratum. Nearly 80% of new-onset AF patients had high CHA2DS2-VASc stroke risk, and 70% were not on anticoagulation therapy. Age was the only significant predictor of new-onset AF. CONCLUSION: A 99.7% detection accuracy for AHRE ≥1 h in patients with DX ICD systems in combination with daily RM allows a reliable guideline-recommended screening for subclinical AF and monitoring of AF-duration progression.

Prevalence of Lyme Carditis in Patients with Atrioventricular Blocks.

Infections with Borrelia may cause cardiac conduction system abnormalities, including atrioventricular blocks (AVBs). Therefore, we aimed to identify patients in whom Lyme carditis (LC) could be considered as the initial diagnosis among consecutive subjects who were referred for implantation of a permanent pacemaker due to symptomatic AVBs. To date, such a systematic evaluation has not been reported yet. Validation of the Suspicious Index for Lyme Carditis (SILC) in our study population was considered as an additional goal. We investigated consecutive patients with AVB admitted to our department for a pacemaker implantation. Serological diagnostic tests against Borrelia burgdorferi sensu lato (Bbsl) were performed in those with no obvious cardiac causes of AVB. The final study population consisted of 130 patients (80 M, mean age 67.4 ± 17.6). Lyme carditis was assumed as the initial diagnosis in 16 patients (12%) based on ABV and IgM Bbsl seropositivity. The patients with LC were younger and more frequently manifested constitutional symptoms of infection and fluctuating AVB. The highest prognostic value for identification of LC patients was obtained for the modified SILC, which included the following parameters: (1) age lower than 75 years; (2) risky outdoor activity and living in the countryside; (3) tick bite; (4) constitutional symptoms of Lyme disease; (5) erythema migrans; (6) male sex and (7) fluctuating atrioventricular block. We concluded that diagnostics for LC should be routinely considered in patients with advanced AVB. Modified SILC may identify the patients at risk of LC.

[Wartosc prognostyczna wskazników elektrokardiograficznych zawalu prawej komory w ocenie wewnatrzszpitalnego przebiegu klinicznego u chorych z rozpoznanym zawalem sciany dolnej leczonych interwencyjnie]. / Wartosc prognostyczna wskazników elektrokardiograficznych zawalu prawej komory w ocenie wewnatrzszpitalnego przebiegu klinicznego u chorych z rozpoznanym zawalem sciany dolnej leczonych interwencyjnie.

Myocardial infarction (MI) of the right ventricle (RV) coexists in 20- 60% of patients with inferior MI. There are electrocardiographic indicators which are connected with RV MI, which may also predict unfavorable clinical outcome of in-hospital follow-up. AIM: The aim of the study was determination a value of seven electrocardiographic predictors of RV MI in prognosis of in-hospital complications in patients with inferior MI. MATERIALS AND METHODS: The analysis of hospital files of patients admitted with diagnosis of inferior MI with persistent ST elevation (STEMI) was retrospectively performed. A set of seven RV MI predictors (RVMIP) was assessed from the electrocardiographic tracings (ECG). Finally in group of 167 patients relation between each RVMIP and in-hospital complications was statistically evaluated. RESULTS: The most often RVMIP was an elevation of ST higher in III lead then in II and aVF (RVMIP-2; recorded in 61,7% patients). In total any RVMIP was found in ECG of 142 patients (85%). Patients who had more RVMIP were more prone for combined adverse cardiac event (CACE, which included artificial respirotherapy, lungs edema and cardiogenic shock) (p=0,012); ventricular arrhythmias (p<0,001) and second/third grade atrioventricular blocks (p=0,028). Advanced atrioventricular blocks were more often observed in patient with ST elevation in V1 and ST depression in aVL (OR=4,91, p=0,005; OR=4,67, p=0,006; respectively). On the other hand second/third grade atrioventricular blocks were also related to higher incidence of CACE, ventricular arrhythmias and atrial fibrillation (AF), respectively: OR=8,1, p<0,001; OR=7,19, p=0,001; OR=5,75, p=0,001). CONCLUSIONS: The more RVMIPs the higher risk of in-hospital complication in patients with inferior MI. The second/third grade atrioventricular blocks were recorded more often in patients with ST elevation in V1 and ST depression in aVL. Advanced atrioventricular conduction blocks were related to worse outcome of in-hospital followup. A detailed ECG analysis in admission still adds important contribution in determination of in-hospital risk of complications.

Baseline clinical characteristics of heart failure patients with reduced ejection fraction enrolled in the BUDAPEST-CRT Upgrade trial.

AIMS: The BUDAPEST-CRT Upgrade study is the first prospective, randomized, multicentre clinical trial investigating the outcomes after cardiac resynchronization therapy (CRT) upgrade in heart failure (HF) patients with intermittent or permanent right ventricular (RV) pacing with wide paced QRS. This report describes the baseline clinical characteristics of the enrolled patients and compares them to cohorts from previous milestone CRT studies. METHODS AND RESULTS: This international multicentre randomized controlled trial investigates 360 patients having a pacemaker (PM) or implantable cardioverter defibrillator (ICD) device for at least 6 months prior to enrolment, reduced left ventricular ejection fraction (LVEF ≤35%), HF symptoms (New York Heart Association [NYHA] functional class II-IVa), wide paced QRS (>150 ms), and ≥20% of RV pacing burden without having a native left bundle branch block. At enrolment, the mean age of the patients was 73 ± 8 years; 89% were male, 97% were in NYHA class II/III functional class, and 56% had atrial fibrillation. Enrolled patients predominantly had conventional PM devices, with a mean RV pacing burden of 86%. Thus, this is a patient cohort with advanced HF, low baseline LVEF (25 ± 7%), high N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (2231 pg/ml [25th-75th percentile 1254-4309 pg/ml]), and frequent HF hospitalizations during the preceding 12 months (50%). CONCLUSION: When compared with prior CRT trial cohorts, the BUDAPEST-CRT Upgrade study includes older patients with a strong male predominance and a high burden of atrial fibrillation and other comorbidities. Moreover, this cohort represents an advanced HF population with low LVEF, high NT-proBNP, and frequent previous HF events. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT02270840.

Systemic Brucellosis with Arrhythmogenic Cardiac Inflammatory Pseudotumor.

BACKGROUND Cardiac inflammatory pseudotumors are rarely observed. Their etiology might include immunologic abnormalities, fibrogenetic disorders, specific reactions to infections or abnormalities related to trauma, necrosis, or neoplasm. Life-threatening ventricular tachycardia and cases of sudden death related to cardiac tumors have been reported. The present report describes and discusses diagnostic and therapeutic solutions for the treatment of nonsarcoid multiorgan pseudotumors with cardiac involvement. CASE REPORT A 38-year-old woman presented to the clinic with symptomatic ventricular tachycardia. As coronary artery disease, cardiomyopathy, and channelopathy were ruled out, and electrocardiograms were not typical of idiopathic arrhythmia, the patient underwent detailed diagnostics which included targeted endomyocardial biopsy, which revealed a cardiac inflammatory pseudotumor. Laborious testing (and eventually, antibiotic therapy) led to ex juvantibus diagnosis of multiorgan disseminated brucellosis with cardiac involvement. Treatment with ceftriaxone, doxycycline, and rifampicin resulted in a complete resolution of all lesions after 3 months, and sustained recovery was observed during a 5-year follow-up. As the risk of ventricular tachycardia could not be reliably predicted, the patient had a subcutaneous implantable cardioverter-defibrillator implanted. CONCLUSIONS A vast diagnostic armamentarium of modern medicine allowed us to diagnose an unsuspected and rare cardiac inflammatory pseudotumor. In the case of travelers, the possibility of regionally specific illnesses, especially infections, must be taken into consideration as possible causes of arrhythmias. Cardiac magnetic resonance imaging may be useful in patients with 'idiopathic ventricular tachycardias' to detect non-apparent myocardial lesions which may result from the underlying cause of the arrhythmia.

The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial.

The sodium-glucose cotransporter 2 inhibitor empagliflozin reduces the risk of cardiovascular death or heart failure hospitalization in patients with chronic heart failure, but whether empagliflozin also improves clinical outcomes when initiated in patients who are hospitalized for acute heart failure is unknown. In this double-blind trial (EMPULSE; NCT04157751 ), 530 patients with a primary diagnosis of acute de novo or decompensated chronic heart failure regardless of left ventricular ejection fraction were randomly assigned to receive empagliflozin 10 mg once daily or placebo. Patients were randomized in-hospital when clinically stable (median time from hospital admission to randomization, 3 days) and were treated for up to 90 days. The primary outcome of the trial was clinical benefit, defined as a hierarchical composite of death from any cause, number of heart failure events and time to first heart failure event, or a 5 point or greater difference in change from baseline in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score at 90 days, as assessed using a win ratio. More patients treated with empagliflozin had clinical benefit compared with placebo (stratified win ratio, 1.36; 95% confidence interval, 1.09-1.68; P = 0.0054), meeting the primary endpoint. Clinical benefit was observed for both acute de novo and decompensated chronic heart failure and was observed regardless of ejection fraction or the presence or absence of diabetes. Empagliflozin was well tolerated; serious adverse events were reported in 32.3% and 43.6% of the empagliflozin- and placebo-treated patients, respectively. These findings indicate that initiation of empagliflozin in patients hospitalized for acute heart failure is well tolerated and results in significant clinical benefit in the 90 days after starting treatment.

Clinical valuation of ST changes in a group of patients with ventricular arrhythmias: The inSighT Study.

BACKGROUND: The inSighT study was designed to determine the prevalence of ischemic changes as recorded by implantable cardioverter-defibrillator (ICD) ST deviations in intracardiac electrocardiograms (EGM) over the 24 h preceding malignant ventricular arrhythmias (VT/VF). METHODS: The study enrolled patients with known coronary artery disease (CAD) or high risk of future development of CAD implanted with an ICD equipped with an ST monitoring feature (Ellipse™/Fortify Assura™, St. Jude Medical). Device session records were collected at each in-clinic follow-up. EGM ST levels of the beats over the 15 minutes prior to VT/VF events were compared using a t test with those from a baseline period of 23-24 h prior to the VT/VF event. All events with p < .05 were visually inspected to confirm they were evaluable; additional criteria for exclusion from further analysis included inappropriate therapy, aberrant conduction, and occurrence of VT/VF within 24h prior to the current event. RESULTS: The study enrolled 481 ICD patients (64 ± 11 years, 83% male) in 14 countries and followed them for 15±5 months. A total of 165 confirmed VT/VF episodes were observed, of which 71 events (in 56 patients, 34% of all patients with VT/VF) were preceded by significant (p < .05) ST-segment changes unrelated to known non-ischemic causes. None of the analyzed demographic and clinical factors proved to be associated with greater odds of presenting with ST-segment changes prior to VT/VF episode. CONCLUSION: In this exploratory study, characteristic ST-segment changes, likely representative of ischemic events, were observed in 34% of all patients with VT/VF episodes.

The safety, efficacy, and cost-effectiveness of gentamycin-collagen sponge in multicomponent prevention strategy of cardiac implantable electronic device infections - a single-center experience.

BACKGROUND: Cardiac implantable electronic device(CIED)infections are associated with significant morbidity, mortality, and increased healthcare expenses. Apart from standard systemic antibiotic therapy, locally acting agents are under investigation as a potential approach for the prevention of this complication. AIMS: The study aimed to summarize our experience with a gentamycin-collagen sponge (GCS) in a multi-component prevention strategy of cardiac implantable electronic device infection. METHODS: We retrospectively analyzed medical records of 312 consecutive patients who underwent CIED-related surgery and had at least a 6-month follow-up. All the individuals had GCS applied during surgery. An incidence of CIEDs-related infection in our group was compared to the risk level calculated according to the commonly used scores. Analysis of cost-effectiveness was also performed. RESULTS: Incidence of CIED-related infection, defined as a primary endpoint, occurred relatively rarely (0.33%) as compared to the infection risk calculated according to commonly used scores Prevention of Arrythmia Device Infection Trial (PADIT) - 0.83%; CIED-AI - 0.90% or Mittal score - 1.00%; P<0.001 - for all). We did not record any complications related to GCS. We analyzed the cost-effectiveness of our GCS-based approach, which appeared to be financially beneficial (number needed to treat 149-200; difference of CIED infection treatment cost and GCSs price was 5093-26525 $). CONCLUSIONS: We conclude that: (1) the use of GCS to reduce CIEDs infections is feasible and safe; (2) our multicomponent prevention strategy involving the GCS application seems to significantly reduce the rate of CIED infection, and it is cost-effective.

Percutaneous Occlusion of the Left Atrial Appendage with Thrombus Irresponsive to Antithrombotic Therapy.

We analyzed clinical experience with percutaneous closure of instances of left atrial appendage with thrombus (LAAT) irresponsive to antithrombotic therapy in patients treated in three high-volume cardiology centers. Clinical and procedural data regarding consecutive patients who underwent percutaneous left atrial appendage closure (PLAAC) due to LAAT were retrospectively analyzed. The study population consisted of 17 patients (11 men; 68 ± 14 years; CHA2DS2VASC 4.7 ± 1.9; HASBLED 3 (0-5)) with LAAT confirmed by transesophageal echocardiography, and included 5 patients with mechanical heart valves. Most of the patients (94.1%) received anticoagulation therapy before PLAAC. All LAATs were located in distal portions of the appendage and occupied less than 30% of its volume. Occluding-device implantation was successful in 17 patients; in one, a residual leak was disclosed. Appropriate positioning of occluders required more than 1 attempt in 6 individuals (35.3%); in 3 others (17.6%), the subjects' devices had contact with thrombi. No procedural complications were noted. Midterm follow-up (median: 10 months) revealed no procedure-related complications or clinically diagnosed thromboembolism. Transesophageal echocardiography (TEE) performed after six months revealed device-related thrombus in one patient. We concluded that LAAT irresponsive to antithrombotic therapy might be effectively treated with PLAAC, even in patients with mechanical-valve prostheses.

Effect of empagliflozin on exercise ability and symptoms in heart failure patients with reduced and preserved ejection fraction, with and without type 2 diabetes.

AIMS: The EMPERIAL (Effect of EMPagliflozin on ExeRcise ability and HF symptoms In patients with chronic heArt faiLure) trials evaluated the effects of empagliflozin on exercise ability and patient-reported outcomes in heart failure (HF) with reduced and preserved ejection fraction (EF), with and without type 2 diabetes (T2D), reporting, for the first time, the effects of sodium-glucose co-transporter-2 inhibition in HF with preserved EF (HFpEF). METHODS AND RESULTS: HF patients with reduced EF (HFrEF) (≤40%, N = 312, EMPERIAL-Reduced) or preserved EF (>40%, N = 315, EMPERIAL-Preserved), with and without T2D, were randomized to empagliflozin 10 mg or placebo for 12 weeks. The primary endpoint was 6-minute walk test distance (6MWTD) change to Week 12. Key secondary endpoints included Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) and Chronic Heart Failure Questionnaire Self-Administered Standardized format (CHQ-SAS) dyspnoea score. 6MWTD median (95% confidence interval) differences, empagliflozin vs. placebo, at Week 12 were -4.0 m (-16.0, 6.0; P = 0.42) and 4.0 m (-5.0, 13.0; P = 0.37) in EMPERIAL-Reduced and EMPERIAL-Preserved, respectively. As the primary endpoint was non-significant, all secondary endpoints were considered exploratory. Changes in KCCQ-TSS and CHQ-SAS dyspnoea score were non-significant. Improvements with empagliflozin in exploratory pre-specified analyses of KCCQ-TSS responder rates, congestion score, and diuretic use in EMPERIAL-Reduced are hypothesis generating. Empagliflozin adverse events were consistent with those previously reported. CONCLUSION: The primary outcome for both trials was neutral. Empagliflozin was well tolerated in HF patients, with and without T2D, with a safety profile consistent with that previously reported in T2D. Hypothesis-generating improvements in exploratory analyses of secondary endpoints with empagliflozin in HFrEF were observed.

Influence of decompensated heart failure on cardiac acoustic biomarkers: impact on early readmissions.

AIMS: Preventing hospitalization by detecting early evidence of heart failure (HF) decompensation in an outpatient setting can improve patient's quality of life and reduce costs of care. The purpose of this study was to assess the value of cardiac acoustic biomarkers (CABs), a combination of cardiohaemic vibrations synchronized with ECG signals, and heart rate (HR) for detecting HF decompensation during first 3 months after hospital discharge for HF. METHODS AND RESULTS: Patients with an ejection fraction ≤35% (HFrEF) and hospitalized for decompensated HF were enrolled in a prospective observational study. All subjects wore a wearable cardioverter-defibrillator (ZOLL LifeVest® , Pittsburgh, PA, USA) that is capable of recording CABs and HR. The primary endpoint of the study was the first HF event, defined as HF readmission or HF emergency room visit. From June 2017 through August 2019, 671 patients with HFrEF were enrolled. Eighty-one patients (12.1%) had a total of 112 HF events. The algorithm detected HF events with a median of 32 days (interquartile range = 11-45) in advance of the first HF event. The algorithm had a sensitivity of 69%, specificity of 60%, positive predictive value of 19%, and a negative predictive value of 94%. Of note, the baseline (first 7 days post-enrolment) algorithm using CABs and HR was superior to New York Heart Association classification in detecting patients more likely to have HF decompensation (sensitivity and specificity of 61% and 68% vs. 46% and 55%, respectively). CONCLUSIONS: This prospective international registry showed that an algorithm incorporating CABs and HR data detected HF events 30 days in advance of the event in patients with HFrEF during first 3 months after hospital discharge. Therefore, integrating CAB technology into clinical practice may prevent HF rehospitalizations.

New Polish prototypes of 4- and 8-mm-tip nonirrigated radiofrequency ablation catheters: an in vitro study.

BACKGROUND: Effectiveness of lesion formation during radiofrequency (RF) catheter ablation can be assessed using in vitro or in vivo animal models. AIMS: In this in vitro study, we aimed to compare the prototypes of the first Polish RF ablation catheters with common commercially available catheters from other manufacturers. METHODS: Samples of the porcine left ventricle were subject to temperature-controlled ablation (50 W / 50 oC / 60 s), using 4- and 8-mm -tip nonirrigated ablation catheters (commercial ones as well as new prototypes). The parameters of RF delivery were collected during energy applications. Subsequently, lesion dimensions were measured and compared between catheters. RESULTS: Initial impedance and impedance drop during energy delivery differed significantly between catheters (both those with 4-mm and 8-mm tip electrodes). The maximum temperature was similar for 4-mm -tip catheters (P = 0.26), while it differed for 8-mm -tip ones (P <0.001). No significant differences between catheters were noted for lesion volume. The 8-mm -tip prototypes created lesions of greater depth (mean [SD], 5.8 [0.4] mm vs 4.7 [0.4] mm; P <0.001) and volume (mean [interquartile range], 239.4 [217.9-255.5] mm3 vs 173.7 [156.1-186.4] mm3; P <0.001) than those with a 4-mm tip electrode. CONCLUSIONS: Our study showed that RF ablation catheters with the same length of the tip electrode created lesions of similar volume, irrespective of the manufacturer and despite showing distinct physical parameters during energy applications. The Polish catheter prototypes showed similar performance as commercially available devices. Finally, 8-mm -tip prototypes produced lesions of greater depth and volume than those with a 4-mm tip electrode.

Multicentre early experience with totally subcutaneous cardioverter-defibrillators in Poland.

INTRODUCTION: Implantable cardioverter-defibrillators (ICD) have a strong position in the prevention of sudden death. Nowadays, the most commonly used high-energy cardiac devices are transvenous ICDs. A new technology of totally subcutaneous ICDs (S-ICD) was invented and recently introduced into clinical practice in order to reduce lead-related complications of conventional ICDs. The aim of this paper is to present early experience with this new technology implemented in a few centres in Poland. MATERIAL AND METHODS: Medical records of patients who had S-ICD-related interventions in Poland were retrospectively analysed. RESULTS: During the first year of S-ICD introduction into the Polish health system 18 patients underwent surgery connected with S-ICDs. Majority of them (17 patients) were implanted de novo. In one patient surgical revision of a device implanted abroad was performed. Most of patients (78%) had S-ICDs implanted for secondary prevention. Inability of transvenous system implantation due to venous access obstruction or high risk of infection related with transvenous leads accounted for 83% of indications for S-ICD. Only in three patients were S-ICDs implanted due to young age and active mode of life. The implantations of S-ICDs were performed without important early or late complications. During follow-up one patient had episodes of ventricular arrhythmia successfully terminated with high-energy shocks. One patient died due to progression of heart failure. CONCLUSIONS: S-ICD implantation procedure has been successfully and safely introduced in Polish clinical routine. Nevertheless, despite clear indications in recent ESC guidelines, this therapy is not directly reimbursed in Poland and needs individual application for refund.