Employment of the Evolution RL sheath as a first-choice device shortens transvenous lead extraction time without affecting procedural safety and efficacy compared to its auxiliary use: Insights from the prospective multicenter EVO registry.

BACKGROUND: Transvenous lead extraction (TLE) is recommended in cases of local and systemic infections related to cardiac implantable electronic devices (CIEDs). Additionally, TLE is indicated in the event of lead damage or CIED malfunction. The extraction procedure is associated with a risk of life-threatening complications. OBJECTIVES: The aim of the EVO registry was to assess the safety and efficacy of birotational Evolution tool usage. MATERIAL AND METHODS: This registry study was prospectively conducted in 8 high-volume implantation centers in Poland. The study included 133 patients aged 63.5 ±15.1 years, and 76.69% were male. Indications for the procedure were: local or systemic infection (33.1%) and lead dysfunction (66.9%). The number of leads extracted varied from 1 (39.84%) to 3 (9.77%). RESULTS: Clinical procedural success was achieved in 99.1% of cases. A total of 226 leads were extracted, and 206 used the Evolution system. Two procedural strategies were identified while using the Evolution system: (1) usage of locking stylet, propylene sheaths and the Evolution system (118 leads, 52%) - group A; (2) usage of locking stylet and Evolution (88 leads, 39%) - group B. There were no differences in the number of complications between these 2 groups. The extraction time was significantly shorter (p = 0.02) in group B than in group A. Major complications occurred in 5.2% of cases with 2 intraprocedural deaths. Minor complications occurred in 1.5% of patients. CONCLUSIONS: The registry confirmed the efficacy and relative safety of the birotational Evolution sheath. Using the rotational sheath as a first attempt significantly reduces extraction time without compromising its safety.

Subcutaneous implantable cardioverter-defibrillator therapy in Poland: Results of the Polish S-ICD Registry.

BACKGROUND: The use of subcutaneous implantable cardioverter-defibrillators (S-ICD) has been growing in Poland since 2014. The Polish Registry of S-ICD Implantations was run by the Heart Rhythm Section of the Polish Cardiac Society between May 2020 and September 2022 to monitor the implementation of that therapy in Poland. AIMS: To investigate and present the state-of-the-art of S-ICD implantation in Poland. METHODS: Implanting centers reported clinical data of patients undergoing S-ICD implantations and replacements, including age, sex, height, weight, underlying disease, history of pacemaker and defibrillator implantations, indications for S-ICD, electrocardiographical parameters, procedural techniques, and complications. RESULTS: Four hundred and forty patients undergoing S-ICD implantation (411) or replacement (29) were reported by 16 centers. Most patients were in New York Heart Association class II (218 patients, 53%) or I (150 patients, 36.5%). Left ventricular ejection fraction was 10%-80%, median (IQR) was 33% (25%-55%). Primary prevention indications were present in 273 patients (66.4%). Non-ischemic cardiomyopathy was reported in 194 patients (47.2%). The main reason for the choice of S-ICD were: young age (309, 75.2%), risk of infectious complications (46, 11.2%), prior infective endocarditis (36, 8.8%), hemodialysis (23, 5.6%), and immunosuppressive therapy (7, 1.7%). Electrocardiographic screening was performed in 90% of patients. The rate of adverse events was low (1.7%). No surgical complications were observed.

Use of an exercise test to enhance sensing vector assessment and prevent inadequate subcutaneous implantable cardioverter-defibrillator discharges.

Subcutaneous implantable cardioverter-defibrillators are a modern alternative to classic cardioverter-defibrillators. Prior to implantation of the device, qualification based on assessment of the heart's specific rhythm shape during a resting electrocardiogram examination must be performed. In the presented case, a patient with a subcutaneous implantable cardioverter-defibrillator experienced numerous discharges during exercise. An exercise test was performed, which revealed a bundle branch block that appeared during exercise. The wide QRS complex was double- or triple-counted by the device, resulting in an inaccurate heart rate estimation and multiple discharges. Optimising the sensing vectors during exercise solved this problem.

Children and young adults treated with transvenous and subcutaneous implantable cardioverter-defibrillators: a 22-year single-center experience and new perspectives.

BACKGROUND: Over the last several years the evolution of transvenous implantable cardioverter­defibrillator (T­ICD) system and the introduction of subcutaneous ICD (S­ICD) have contributed to the development of the sudden cardiac death (SCD) prevention in clinical practice. AIMS: To report our clinical experience with ICD therapy in children and young adults during the twenty­ ­two years of the follow­up. METHODS: We reviewed the database of ICD recipients choosing 80 consecutive patients (pts) implanted at the age of 6-21 in 1996-2018. We analyzed the rate of appropriate (AT) and inappropriate therapies (IT), mortality, complications and new treatment options. RESULTS: A total of 21/80 patients (26.25%) received ≥1 AT for ventricular tachycardia/ventricular fibrillation (anti­tachycardia pacing or shock) and 25/80 patients (31.25%) had one or multiple IT (P = 0.47). Nine patients (11%) had both AT and IT interventions. During follow­up, 2 (2.5%) cardiac resynchronization therapy (CRT) systems, and 8 (10%) S­ICDs were implanted, 3 heart transplantations were performed, and 1 severe tricuspid valve regurgitation occurred. A total of 6/80 patients (7.5%) died. All deaths occurred in the hypertrophic cardiomyopathy group. CONCLUSIONS: The mortality rate was 6/80 (7.5%) in the twenty­two­year follow­up. The rate of AT vs. IT was almost equal and remained steady in the long observation period. Severe TR might be a serious clinical problem in some patients. Entirely S­ICD for SCD prevention is a feasible and safe therapy in young recipients.

A Recurrent Exertional Syncope and Sudden Cardiac Arrest in a Young Athlete with Known Pathogenic p.Arg420Gln Variant in the RYR2 Gene.

Catecholaminergic polymorphic ventricular tachycardia (CPVT) is one of causes of sudden cardiac death in the young, especially in athletes. Diagnosis of CPVT may be difficult since all cardiological examinations performed at rest are usually normal, and exercise stress test-induced ventricular tachycardia is not commonly present. The identification of a pathogenic mutation in RYR2 or CASQ2 is diagnostic in CPVT. We report on a 20-year-old athlete who survived two sudden cardiac arrests during swimming. Moreover, he suffered repeated syncopal spells on exercise. The diagnosis was made only following genetic testing using a multi-gene panel, and the p.Arg420Gln RYR2 variant was identified. We present diagnostic and therapeutic issues in this young athlete with CPVT.

Clinical efficacy of potassium canreonate-canrenone in sinus rhythm restoration among patients with atrial fibrillation - a protocol of a pilot, randomized, double -blind, placebo-controlled study (CANREN-AF trial).

BACKGROUND: Atrial fibrillation (AF) is the most frequent cardiac arrhythmia which increases the risk of thromboembolic complications and impairs quality of life. An important part of a therapeutic approach for AF is sinus rhythm restoration. Antiarrhythmic agents used in pharmacological cardioversion have limited efficacy and potential risk of proarrhythmia. Simultaneously, underlying conditions of AF should be treated (e.g. electrolyte imbalance, increased blood pressure, neurohormonal disturbances, atrial volume overload). There is still the need for an effective and safe approach to increase AF cardioversion efficacy. This randomized, double-blind, placebo-controlled, superiority clinical study is performed in patients with AF in order to evaluate the clinical efficacy of intravenous canrenone in sinus rhythm restoration. METHODS: Eighty eligible patients with an episode of AF lasting less than 48 h are randomized in a 1:1 ratio to receive canrenone or placebo. Patients randomized to a treatment intervention are receiving canrenone intravenously at a dose of 200 mg within 2-3 min. Subjects assigned to a control group obtain the same volume of 0.9% saline within the same time. The primary endpoint includes return of sinus rhythm documented in the electrocardiogram within 2 h after drug or placebo administration. Other endpoints and safety outcomes analyses, due to expected lack of statistical power, are exploratory. DISCUSSION: Current evidence supports renin-angiotensin-aldosterone system (RAAS) inhibition as an upstream therapy in AF management. Excess aldosterone secretion results in proarrhythmic effects. Among the RAAS inhibitors, only canrenone is administered intravenously. Canrenone additionally increases the plasma level of potassium, lowers blood pressure and reduces preload. It has been already used in primary and secondary hyperaldosteronism in the course of chronic liver dysfunction and in heart failure. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03536806. Registered on 25 May 2018.

The long term risk of lead failure in patients with cardiovascular implantable electronic devices undergoing catheter ablation.

Objectives. The aim of the study was to assess the long-term influence of catheter ablation (CA) of different arrhythmias on cardiovascular implantable electronic devices (CIED) endocardial leads durability. Design. This was a retrospective case-control study. Ablation protocols and in- or outpatient medical records were reviewed to identify and extract data on adult patients with CIED undergoing a CA. A cohort of patients with hypertrophic cardiomyopathy and implantable cardioverter-defibrillators (ICD) served as a historical control group. The primary endpoint was the diagnosis of lead damage defined as permanent loss of proper function demanding replacement or removal. Results. Among 145 patients n = 177 catheter ablations were performed. Patients' mean age was 66.4 ± 10.5, 66.1% had an ICD or ICD with cardiac resynchronization function (CRT-D), 18.1% had >1 CA. During median 812 days [IQR 381-1588] of follow-up, there were 11 (6.2%) cases of lead damage in the examined and 13 cases (13%) in the control group, p = 0.054. None of the technical aspects of the CA (indication, type of catheter, transseptal sheath) influenced the primary outcome. Both the number of leads and observation time after CA were significantly related to the risk of endocardial lead damage. Conclusion. This study did not find any significant influence of CA on the long-term durability of CIED endocardial leads. Reported risk factors were consistent with general population of CIED patients.

Fifteen years' experience of implantable cardioverter defibrillator in children and young adults: Mortality and complications study.

BACKGROUND: Young implantable cardioverter defibrillator (ICD) recipients have a high rate of complications, some of which seem to be underestimated. We report our clinical experience with ICD therapy in children and young adults during a 15 year follow up. METHODS: We reviewed the database of ICD recipients at the present institution and chose 73 consecutive patients who underwent implantation at age 6-21 years. We analyzed intervention rate, mortality, rate and characteristics of complications and treatment options. RESULTS: A total of 20/73 patients (27.4%) received ≥1 episode of appropriate therapy (AT) for ventricular tachycardia/ventricular fibrillation (anti-tachycardia pacing or shock) and 24/73 patients (32.8%) had one or multiple episodes of inappropriate therapy (IT). Eight patients (11%) had both interventions: AT + IT. A total of 15/73 patients (20.5%) had ventricular lead dysfunction, with 13 re-implantations (17.8%) of a new system. Four of 73 patients (5.5%) had infection: endocarditis or device pocket infection. A total of 2/73 patients (2.7%) died due to ventricular lead dysfunction, while 22/73 patients (30.1%) needed elective device replacement, five of them twice (6.8%). CONCLUSION: Endocardial ICD implantation in children and young adults is a feasible and life-saving procedure, according to the present 15 year follow up. The rate of complications including IT was high: 72.8% in the young ICD recipients. Re-implantation of a new system was often required due to ventricular lead dysfunction or infection in 25% of the patients.

Peri-procedural routines, implantation techniques, and procedure-related complications in patients undergoing implantation of subcutaneous or transvenous automatic cardioverter-defibrillators: results of the European Snapshot Survey on S-ICD Implantation (ESSS-SICDI).

The aim of this European Heart Rhythm Association (EHRA) prospective snapshot survey is to assess peri-procedural practices, implantation techniques, and short-term procedure-related complications associated with implantation of subcutaneous implantable cardioverter-defibrillator (S-ICD) or transvenous implantable cardioverter-defibrillator (TV-ICD), across tertiary European electrophysiology centres. An internet-based electronic questionnaire concerning implantation settings, peri-procedural routines, techniques, personnel, complications, and patient outcomes was sent to the centres routinely implanting both TV-ICDs and S-ICDs. The centres were requested to prospectively include consecutive patients implanted with either TV-ICD or S-ICD during the 8-week enrolment period. Overall, 20 centres from 6 countries enrolled 429 consecutive patients. Subcutaneous implantable cardioverter-defibrillators (20%) compared with TV-ICD were implanted mainly under general anaesthesia (72% vs. 14%), in the surgical operation room settings (69% vs. 43%), with more frequent prophylactic antibiotic administration (82% vs. 91%), and post-implant defibrillation testing (85% vs. 7%, all P < 0.05). Feasibility (implantation duration of 45 min) and short-term complication rates (4%) were comparable for S-ICDs and TV-ICDs, but the spectrum of complications varied, despite different baseline characteristics of patients undergoing the S-ICD vs. TV-ICD implantation. This EHRA snapshot survey provides important insights into the implantable cardioverter-defibrillator implantation routines and patient outcomes. Our study showed differences between the S-ICD and TV-ICD implantation routines with respect to implantation settings, peri-procedural management, and pre-defined procedural endpoints. However, the comparable duration of S-ICD or TV-ICD implantation and similar rates of peri-procedural complications indicate that both devices can be routinely used in clinical practice.

Occurrence and extraction of implantable cardioverter-defibrillator leads with conductor externalization.

BACKGROUND: The increasing number of patients with implantable cardioverter-defibrillators (ICD) contributes to the rising number of patients qualifying for a transvenous lead extraction (TLE) due to infection, vascular or lead failure related indications. The purpose of this study was to perform a retrospective analysis of the occurrence of conductor externalization in TLE patients and to assess the success rate in the extraction of these leads. METHODS: TLE procedure was performed between 2012 and 2014 of 428 electrodes in 259 patients. Out of these, 143 (33.4%) leads in 138 (52.9%) patients were ICD leads. The indications for the TLE in ICD patients were: infection in 37 patients, lead failure in 84 patients, and others in 17 patients. Conductor externalization was observed in 8 ICD leads (5.6%) in 8 (5.8%) patients. The mean dwell-ing time for externalized leads was 87.9 (55 to 132) months compared to 60.1 (3 to 246) months of the remaining 135 ICD leads (p = 0.0329). All externalized leads were successfully and completely extracted using device traction, mechanical telescopic sheaths and/or autorotational cutting sheaths. No complica-tions of lead extraction procedures were observed in 8 patients with externalization. RESULTS: Patients with lead externalization were often in a better New York Heart Association func-tional class (I or II) compared to those in the rest of the study group (p = 0.0212). CONCLUSIONS: Conductor externalization is a rare finding in patients undergoing TLE. This occurs with different manufacturers and lead types. In this complication transvenous lead extraction with the mechanical extraction tools can be safely performed.

Clinical, echocardiographic, and pacing parameters affecting atrial fibrillation burden in patients with tachycardia-bradycardia syndrome.

BACKGROUND: The influence of various factors on atrial fibrillation (AF) development in the population of tachycardia-bradycardia syndrome (TBS) patients remains unclear. There are no data on the impact of different right ventricular pacing percentage (RVp%) profiles. AIM: The purpose of the study was to evaluate the relationship between the AF burden (AFB) and various clinical, echocardiographic, and pacing parameters in TBS patients. METHODS: We performed a prospective, one-year registry of TBS patients with documented AF referred for dual-chamber pacemaker (DDD) implantation. RESULTS: The data of 65 patients were analysed. The median 12-month RVp% and AFB was 9.4% and 1.0%, respectively. During the follow-up 14% of patients had no AF (p = 0.003), and the withdrawal of AF symptoms was observed in 49% of patients (p < 0.0001). The AFB was related to the left atrium diameter (r = 0.31, p = 0.02), especially in the subjects with left ventricular ejection fraction < 60% (r = 0.44, p = 0.04). Based on the relative change of RVp%, three groups of various RVp% profile were established: stable, decreasing, and increasing RVp%. In the stable RVp% group (n = 21) there was a quadratic correlation between the 12-month RVp% and AFB (r = 0.71, p = 0.0003). In the stable RVp% > 20% subgroup there was a significant increase of AFB in comparison to the RVp% ≤ 20% subgroup (ΔAFB 1.8% vs. 0.0%, p = 0.03, respectively). In the increasing RVp% group (n = 28) the AFB increased whereas in the decreasing RVp% (n = 16) it remained stable (ΔAFB 0.67% vs. 0.0%, p = 0.034, respectively). CONCLUSIONS: DDD implantation in TBS patients is related to a significant reduction in AF symptoms, and left atrial diameter correlates with cumulative AFB in the mid-term observation. Stable RVp% > 20% is associated with AF progression whereas lower stable RVp% may stabilise AF development. Increasing RVp% may be associated with the AFB increase in comparison to the decreasing RVp% subgroup in which AFB remains stable.