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1.
Europace ; 26(5)2024 May 02.
Article in English | MEDLINE | ID: mdl-38781099

ABSTRACT

AIMS: Cardioneuroablation (CNA) is a catheter-based intervention for recurrent vasovagal syncope (VVS) that consists in the modulation of the parasympathetic cardiac autonomic nervous system. This survey aims to provide a comprehensive overview of current CNA utilization in Europe. METHODS AND RESULTS: A total of 202 participants from 40 different countries replied to the survey. Half of the respondents have performed a CNA during the last 12 months, reflecting that it is considered a treatment option of a subset of patients. Seventy-one per cent of respondents adopt an approach targeting ganglionated plexuses (GPs) systematically in both the right atrium (RA) and left atrium (LA). The second most common strategy (16%) involves LA GP ablation only after no response following RA ablation. The procedural endpoint is frequently an increase in heart rate. Ganglionated plexus localization predominantly relies on an anatomical approach (90%) and electrogram analysis (59%). Less utilized methods include pre-procedural imaging (20%), high-frequency stimulation (17%), and spectral analysis (10%). Post-CNA, anticoagulation or antiplatelet therapy is prescribed, with only 11% of the respondents discharging patients without such medication. Cardioneuroablation is perceived as effective (80% of respondents) and safe (71% estimated <1% rate of procedure-related complications). Half view CNA emerging as a first-line therapy in the near future. CONCLUSION: This survey offers a snapshot of the current implementation of CNA in Europe. The results show high expectations for the future of CNA, but important heterogeneity exists regarding indications, procedural workflow, and endpoints of CNA. Ongoing efforts are essential to standardize procedural protocols and peri-procedural patient management.


Subject(s)
Catheter Ablation , Syncope, Vasovagal , Humans , Syncope, Vasovagal/physiopathology , Syncope, Vasovagal/surgery , Syncope, Vasovagal/diagnosis , Europe , Catheter Ablation/methods , Workflow , Heart Rate , Treatment Outcome , Health Care Surveys , Practice Patterns, Physicians'/trends , Electrophysiologic Techniques, Cardiac , Surveys and Questionnaires , Ganglia, Autonomic/surgery , Ganglia, Autonomic/physiopathology , Heart Atria/physiopathology , Heart Atria/surgery , Recurrence
2.
Europace ; 26(2)2024 Feb 01.
Article in English | MEDLINE | ID: mdl-38363995

ABSTRACT

Ventricular tachycardia (VT), and its occurrence, is still one of the main reasons for sudden cardiac death and, therefore, for increased mortality and morbidity foremost in patients with structural heart [Kahle A-K, Jungen C, Alken F-A, Scherschel K, Willems S, Pürerfellner H et al. Management of ventricular tachycardia in patients with ischaemic cardiomyopathy: contemporary armamentarium. Europace 2022;24:538-51]. Catheter ablation has become a safe and effective treatment option in patients with recurrent VT [Cronin EM, Bogun FM, Maury P, Peichl P, Chen M, Namboodiri N et al. 2019 HRS/EHRA/APHRS/LAHRS expert consensus statement on catheter ablation of ventricular arrhythmias. Heart Rhythm 2020;17:e2-154]. Previous and current guidelines provide guidance on indication for VT ablation and risk assessment and evaluation of underlying disease. However, no uniform recommendation is provided regarding procedural strategies, timing of ablation, and centre setting. Therefore, these specifics seem to differ largely, and recent data are sparse. This physician-based European Heart Rhythm Association survey aims to deliver insights on not only infrastructural settings but also procedural specifics, applied technologies, ablation strategies, and procedural endpoints. Therefore, these findings might deliver a real-world scenario of VT management and potentially are of guidance for other centres.


Subject(s)
Catheter Ablation , Myocardial Ischemia , Tachycardia, Ventricular , Humans , Workflow , Tachycardia, Ventricular/diagnosis , Tachycardia, Ventricular/surgery , Arrhythmias, Cardiac/surgery , Treatment Outcome , Catheter Ablation/methods
3.
Eur Heart J ; 44(27): 2458-2469, 2023 Jul 14.
Article in English | MEDLINE | ID: mdl-37062040

ABSTRACT

AIMS: Oesophageal fistula represents a rare but dreadful complication of atrial fibrillation catheter ablation. Data on its incidence, management, and outcome are sparse. METHODS AND RESULTS: This international multicentre registry investigates the characteristics of oesophageal fistulae after treatment of atrial fibrillation by catheter ablation. A total of 553 729 catheter ablation procedures (radiofrequency: 62.9%, cryoballoon: 36.2%, other modalities: 0.9%) were performed, at 214 centres in 35 countries. In 78 centres 138 patients [0.025%, radiofrequency: 0.038%, cryoballoon: 0.0015% (P < 0.0001)] were diagnosed with an oesophageal fistula. Peri-procedural data were available for 118 patients (85.5%). Following catheter ablation, the median time to symptoms and the median time to diagnosis were 18 (7.75, 25; range: 0-60) days and 21 (15, 29.5; range: 2-63) days, respectively. The median time from symptom onset to oesophageal fistula diagnosis was 3 (1, 9; range: 0-42) days. The most common initial symptom was fever (59.3%). The diagnosis was established by chest computed tomography in 80.2% of patients. Oesophageal surgery was performed in 47.4% and direct endoscopic treatment in 19.8% and conservative treatment in 32.8% of patients. The overall mortality was 65.8%. Mortality following surgical (51.9%) or endoscopic treatment (56.5%) was significantly lower as compared to conservative management (89.5%) [odds ratio 7.463 (2.414, 23.072) P < 0.001]. CONCLUSION: Oesophageal fistula after catheter ablation of atrial fibrillation is rare and occurs mostly with the use of radiofrequency energy rather than cryoenergy. Mortality without surgical or endoscopic intervention is exceedingly high.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Esophageal Fistula , Humans , Atrial Fibrillation/epidemiology , Atrial Fibrillation/surgery , Atrial Fibrillation/diagnosis , Treatment Outcome , Incidence , Risk Factors , Esophageal Fistula/epidemiology , Esophageal Fistula/etiology , Esophageal Fistula/diagnosis , Prognosis , Catheter Ablation/adverse effects , Catheter Ablation/methods
4.
Circulation ; 145(5): 321-329, 2022 02.
Article in English | MEDLINE | ID: mdl-34779221

ABSTRACT

BACKGROUND: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) showed noninferiority of subcutaneous implantable cardioverter defibrillator (S-ICD) compared with transvenous implantable cardioverter defibrillator (TV-ICD) with regard to inappropriate shocks and complications. In contrast to TV-ICD, S-ICD cannot provide antitachycardia pacing for monomorphic ventricular tachycardia. This prespecified secondary analysis evaluates appropriate therapy and whether antitachycardia pacing reduces the number of appropriate shocks. METHODS: The PRAETORIAN trial was an international, investigator-initiated randomized trial that included patients with an indication for implantable cardioverter defibrillator (ICD) therapy. Patients with previous ventricular tachycardia <170 bpm or refractory recurrent monomorphic ventricular tachycardia were excluded. In 39 centers, 849 patients were randomized to receive an S-ICD (n=426) or TV-ICD (n=423) and were followed for a median of 49.1 months. ICD programming was mandated by protocol. Appropriate ICD therapy was defined as therapy for ventricular arrhythmias. Arrhythmias were classified as discrete episodes and storm episodes (≥3 episodes within 24 hours). Analyses were performed in the modified intention-to-treat population. RESULTS: In the S-ICD group, 86 of 426 patients received appropriate therapy, versus 78 of 423 patients in the TV-ICD group, during a median follow-up of 52 months (48-month Kaplan-Meier estimates 19.4% and 17.5%; P=0.45). In the S-ICD group, 83 patients received at least 1 shock, versus 57 patients in the TV-ICD group (48-month Kaplan-Meier estimates 19.2% and 11.5%; P=0.02). Patients in the S-ICD group had a total of 254 shocks, compared with 228 shocks in the TV-ICD group (P=0.68). First shock efficacy was 93.8% in the S-ICD group and 91.6% in the TV-ICD group (P=0.40). The first antitachycardia pacing attempt successfully terminated 46% of all monomorphic ventricular tachycardias, but accelerated the arrhythmia in 9.4%. Ten patients with S-ICD experienced 13 electrical storms, versus 18 patients with TV-ICD with 19 electrical storms. Patients with appropriate therapy had an almost 2-fold increased relative risk of electrical storms in the TV-ICD group compared with the S-ICD group (P=0.05). CONCLUSIONS: In this trial, no difference was observed in shock efficacy of S-ICD compared with TV-ICD. Although patients in the S-ICD group were more likely to receive an ICD shock, the total number of appropriate shocks was not different between the 2 groups. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.


Subject(s)
Arrhythmias, Cardiac/therapy , Defibrillators, Implantable/standards , Aged , Arrhythmias, Cardiac/diagnosis , Female , Humans , Male , Middle Aged , Prospective Studies , Treatment Outcome
5.
N Engl J Med ; 383(6): 526-536, 2020 08 06.
Article in English | MEDLINE | ID: mdl-32757521

ABSTRACT

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (ICD) was designed to avoid complications related to the transvenous ICD lead by using an entirely extrathoracic placement. Evidence comparing these systems has been based primarily on observational studies. METHODS: We conducted a noninferiority trial in which patients with an indication for an ICD but no indication for pacing were assigned to receive a subcutaneous ICD or transvenous ICD. The primary end point was the composite of device-related complications and inappropriate shocks; the noninferiority margin for the upper boundary of the 95% confidence interval for the hazard ratio (subcutaneous ICD vs. transvenous ICD) was 1.45. A superiority analysis was prespecified if noninferiority was established. Secondary end points included death and appropriate shocks. RESULTS: A total of 849 patients (426 in the subcutaneous ICD group and 423 in the transvenous ICD group) were included in the analyses. At a median follow-up of 49.1 months, a primary end-point event occurred in 68 patients in the subcutaneous ICD group and in 68 patients in the transvenous ICD group (48-month Kaplan-Meier estimated cumulative incidence, 15.1% and 15.7%, respectively; hazard ratio, 0.99; 95% confidence interval [CI], 0.71 to 1.39; P = 0.01 for noninferiority; P = 0.95 for superiority). Device-related complications occurred in 31 patients in the subcutaneous ICD group and in 44 in the transvenous ICD group (hazard ratio, 0.69; 95% CI, 0.44 to 1.09); inappropriate shocks occurred in 41 and 29 patients, respectively (hazard ratio, 1.43; 95% CI, 0.89 to 2.30). Death occurred in 83 patients in the subcutaneous ICD group and in 68 in the transvenous ICD group (hazard ratio, 1.23; 95% CI, 0.89 to 1.70); appropriate shocks occurred in 83 and 57 patients, respectively (hazard ratio, 1.52; 95% CI, 1.08 to 2.12). CONCLUSIONS: In patients with an indication for an ICD but no indication for pacing, the subcutaneous ICD was noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks. (Funded by Boston Scientific; PRAETORIAN ClinicalTrials.gov number, NCT01296022.).


Subject(s)
Arrhythmias, Cardiac/therapy , Defibrillators, Implantable/adverse effects , Aged , Cardiomyopathies/therapy , Death, Sudden, Cardiac/epidemiology , Death, Sudden, Cardiac/prevention & control , Electrodes, Implanted/adverse effects , Equipment Failure , Female , Follow-Up Studies , Heart Diseases/therapy , Humans , Incidence , Kaplan-Meier Estimate , Male , Middle Aged , Prosthesis Design
6.
Europace ; 26(1)2023 12 28.
Article in English | MEDLINE | ID: mdl-38163951

ABSTRACT

AIMS: Pericardial tamponade (PT) is the most frequent severe complication during electrophysiology (EP) procedures and requires immediate, co-ordinated, and effective treatment. However, multiple aspects of PT treatment are either not standardized or are under ongoing debate. METHODS AND RESULTS: An online questionnaire consisting of 26 multiple-choice questions was sent out to the European Heart Rhythm (EHRA) Research Network and also distributed via social media outputs. The EHRA survey was conducted between May and June 2023. A total of 213 replies were received from European (87%) and non-European countries. Ninety per cent of all participants perform interventions in dedicated EP labs equipped with different ablation platforms. In case of PT, most participants use X-ray as the main imaging modality guiding pericardial puncture, predominantly aiming for an anterior puncture site. Sheaths of different sizes are introduced into the pericardial space (84.3%), followed by a pigtail catheter. Application of protamine is an established but variable step in the majority (84.6%). Novel oral anticoagulants (NOAC) antidotes are not used by 73.3% of participants, while 15.2% routinely apply them. Re-transfusion of aspirated blood is performed by 72.1% [before protamine administration (18.2%), after protamine administration (13.5%), if pericardial effusion cannot be controlled (40.4%)]. A total of 72.4% re-transfuse without blood filter systems. A decision for surgical intervention is mostly taken if bleeding continues despite all interventional measures. CONCLUSION: The current survey demonstrates that the management of PT is heterogeneous among centres. The findings of this survey may help to guide operators in their treatment and decisions in the setting of PT.


Subject(s)
Anticoagulants , Cardiac Tamponade , Humans , Anticoagulants/therapeutic use , Cardiac Tamponade/diagnostic imaging , Cardiac Tamponade/etiology , Cardiac Tamponade/prevention & control , Surveys and Questionnaires , Protamines , Electrophysiology
7.
Europace ; 25(3): 1068-1076, 2023 03 30.
Article in English | MEDLINE | ID: mdl-36581450

ABSTRACT

AIMS: Left bundle branch area pacing (LBBAP) can be technically challenging and fluoroscopy-intense. Three-dimensional electroanatomical mapping (EAM) facilitates non-fluoroscopic lead navigation and electrogram mapping. We sought to prospectively evaluate the feasibility, safety, and outcomes of routine EAM-guided LBBAP in patients with structural heart disease (SHD) and advanced conduction abnormalities. METHODS AND RESULTS: Consecutive patients with SHD and conduction abnormalities who underwent an attempt at EAM-guided LBBAP were included. The feasibility, safety, procedural, and mid-term outcomes were evaluated. Electrical, echocardiographic, and clinical parameters were assessed at implantation and last follow-up. Thirty-two patients (68 ± 18 years; 19% female) were included, of which 75% had intrinsic QRS > 150 ms, 53% left bundle branch block, and 25% right bundle branch block. Primary EAM-guided LBBAP was successful in 29 patients (91%). The procedural duration was 95 (70-110) min, total fluoroscopy time 0.93 (0.40-1.73) min, and total fluoroscopy dose 35.4 (20.5-77.2) cGy cm2. Paced QRS duration (QRSd) was significantly shorter than intrinsic QRSd (121.9 ± 10.7 vs. 159.2 ± 34.4 ms; P < 0.001) and remained stable during the mean follow-up of 7.0 ± 5.9 months. The LBBAP capture threshold was 0.57 ± 0.23 V/0.4 ms at implantation and remained low during follow-up (0.58 ± 0.18 V/0.5 ± 0.2 ms; P = 0.877). Overall left ventricular ejection fraction improved significantly from 44.2 ± 14.3% at baseline to 49.4 ± 13.1% at follow-up (P = 0.009), New York Heart Association class from 2.4 ± 0.6 to 1.8 ± 0.6 (P = 0.002), respectively. No complications occurred that required intervention. CONCLUSION: Routine near-zero fluoroscopy EAM-guided LBBAP can safely be performed in patients with SHD and advanced conduction abnormalities with high success rates and favourable mid-term outcomes. Further studies are needed to investigate whether the use of EAM improves the overall outcome of conduction system pacing and to identify specific patient populations who benefit the most from EAM-guided lead implantation.


Subject(s)
Pacemaker, Artificial , Humans , Female , Male , Cardiac Pacing, Artificial/methods , Stroke Volume , Electrocardiography/methods , Ventricular Function, Left , Cardiac Conduction System Disease , Bundle-Branch Block/diagnosis , Bundle-Branch Block/therapy , Bundle-Branch Block/etiology , Bundle of His , Treatment Outcome
8.
Europace ; 25(5)2023 05 19.
Article in English | MEDLINE | ID: mdl-36916199

ABSTRACT

AIMS: The field of conduction system pacing (CSP) is evolving, and our aim was to obtain a contemporary picture of European CSP practice. METHODS AND RESULTS: A survey was devised by a European CSP Expert Group and sent electronically to cardiologists utilizing CSP. A total of 284 physicians were invited to contribute of which 171 physicians (60.2%; 85% electrophysiologists) responded. Most (77%) had experience with both His-bundle pacing (HBP) and left bundle branch area pacing (LBBAP). Pacing indications ranked highest for CSP were atrioventricular block (irrespective of left ventricular ejection fraction) and when coronary sinus lead implantation failed. For patients with left bundle branch block (LBBB) and heart failure (HF), conventional biventricular pacing remained first-line treatment. For most indications, operators preferred LBBAP over HBP as a first-line approach. When HBP was attempted as an initial approach, reasons reported for transitioning to utilizing LBBAP were: (i) high threshold (reported as >2 V at 1 ms), (ii) failure to reverse bundle branch block, or (iii) > 30 min attempting to implant at His-bundle sites. Backup right ventricular lead use for HBP was low (median 20%) and predominated in pace-and-ablate scenarios. Twelve-lead electrocardiogram assessment was deemed highly important during follow-up. This, coupled with limitations from current capture management algorithms, limits remote monitoring for CSP patients. CONCLUSIONS: This survey provides a snapshot of CSP implementation in Europe. Currently, CSP is predominantly used for bradycardia indications. For HF patients with LBBB, most operators reserve CSP for biventricular implant failures. Left bundle branch area pacing ostensibly has practical advantages over HBP and is therefore preferred by many operators. Practical limitations remain, and large randomized clinical trial data are currently lacking.


Subject(s)
Cardiac Resynchronization Therapy , Heart Failure , Humans , Stroke Volume/physiology , Ventricular Function, Left , Treatment Outcome , Heart Conduction System , Bundle-Branch Block/diagnosis , Bundle-Branch Block/therapy , Arrhythmias, Cardiac/therapy , Heart Failure/diagnosis , Heart Failure/therapy
9.
Eur Heart J ; 43(47): 4872-4883, 2022 12 14.
Article in English | MEDLINE | ID: mdl-36030464

ABSTRACT

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is developed to overcome lead-related complications and systemic infections, inherent to transvenous ICD (TV-ICD) therapy. The PRAETORIAN trial demonstrated that the S-ICD is non-inferior to the TV-ICD with regard to the combined primary endpoint of inappropriate shocks and complications. This prespecified secondary analysis evaluates all complications in the PRAETORIAN trial. METHODS AND RESULTS: The PRAETORIAN trial is an international, multicentre, randomized trial in which 849 patients with an indication for ICD therapy were randomized to receive an S- ICD (N = 426) or TV-ICD (N = 423) and followed for a median of 49 months. Endpoints were device-related complications, lead-related complications, systemic infections, and the need for invasive interventions. Thirty-six device-related complications occurred in 31 patients in the S-ICD group of which bleedings were the most frequent. In the TV-ICD group, 49 complications occurred in 44 patients of which lead dysfunction was most frequent (HR: 0.69; P = 0.11). In both groups, half of all complications were within 30 days after implantation. Lead-related complications and systemic infections occurred significantly less in the S-ICD group compared with the TV-ICD group (P < 0.001, P = 0.03, respectively). Significantly more complications required invasive interventions in the TV-ICD group compared with the S-ICD group (8.3% vs. 4.3%, HR: 0.59; P = 0.047). CONCLUSION: This secondary analysis shows that lead-related complications and systemic infections are more prevalent in the TV-ICD group compared with the S-ICD group. In addition, complications in the TV-ICD group were more severe as they required significantly more invasive interventions. This data contributes to shared decision-making in clinical practice.


Subject(s)
Death, Sudden, Cardiac , Defibrillators, Implantable , Humans , Treatment Outcome , Defibrillators, Implantable/adverse effects
10.
J Cardiovasc Electrophysiol ; 33(1): 102-108, 2022 01.
Article in English | MEDLINE | ID: mdl-34783107

ABSTRACT

BACKGROUND: Transvenous lead extraction (TLE) is rising in parallel to cardiac implantable electronic device implantations. Persistent left side superior vena cava (PLSVC) is a relatively common anatomical variant in the healthy population; TLE in patients with a PLSVC is rare. METHOD: Data were collated from 6 European TLE institutes of 10 patients who had undergone lead extraction with a PLSVC. Patient demographics, procedural challenges and outcomes were reported. RESULTS: Ten patients aged 73.4 ± 7.8 years (60% male) underwent TLE of 20 leads (3 left ventricle, 10 right ventricle, 7 right atrium) with dwell time of 82.95 ± 39.1 months. Of the 10 cases, 4 had an infection indication and 5 were biventricular system extractions; 25% of the extracted leads were defibrillator leads. The majority of the procedures were completed in the cardiac catheterization suite (80%) under general anaesthesia (60%) by cardiologists (80%) using a rotational powered sheath (65%). The Tandem approach was used successfully in 3 cases. Complete procedural success was obtained in 100% of cases in the absence of complications within 127.4 ± 74.7 min. There was no 30-day mortality. CONCLUSION: TLE in PLSVC is feasible albeit rare. Standard extraction techniques in experienced hands are associated with favorable outcomes; the Tandem procedure may be an additional technique to improve the safety and efficacy of TLE in PLSVC.


Subject(s)
Defibrillators, Implantable , Pacemaker, Artificial , Persistent Left Superior Vena Cava , Aged , Aged, 80 and over , Defibrillators, Implantable/adverse effects , Device Removal/methods , Female , Humans , Male , Pacemaker, Artificial/adverse effects , Treatment Outcome , Vena Cava, Superior/diagnostic imaging , Vena Cava, Superior/surgery
11.
Europace ; 24(1): 12-19, 2022 01 04.
Article in English | MEDLINE | ID: mdl-34279613

ABSTRACT

AIMS: To establish a cardiovascular magnetic resonance (CMR)-based prediction model for complete systolic left ventricular ejection fraction (LVEF) recovery for the distinction of 'arrhythmia-induced' from 'arrhythmia-mediated' cardiomyopathy in patients with atrial tachyarrhythmias. METHODS AND RESULTS: Two hundred and fifty-three tachyarrhythmia patients referred for catheter ablation were enrolled and underwent CMR baseline imaging; patients with a reduced LVEF <50% at baseline and CMR imaging at 3-month follow-up after successful rhythm restoration constituted the final study population (n = 134). CMR at baseline consisted of standard functional cine imaging, determination of extracellular volume, and late gadolinium enhancement (LGE) imaging; follow-up CMR comprised standard functional cine imaging. Left ventricular end-diastolic volume index (LVEDVI) measurements were categorized in 'opposite', 'normal', and 'enlarged'. At follow-up, 80% (107/134) presented with complete LVEF recovery, while in 20% (27/134) persistent LVEF impairment was observed. LVEDVI and LGE were independent predictors of complete LVEF recovery with LGE adding significant incremental value on logistic regression modelling. Model-derived probabilities for complete LVEF recovery in LVEDVI categories of opposite, normal, and enlarged for LGE negativity and positivity were 94%, 85%, and 29% and 77%, 55%, and 8%, respectively. CONCLUSION: CMR-derived assessment of LVEDVI category and LGE allowed for identification of arrhythmia-induced cardiomyopathy with acceptable discriminative performance. Probabilities for complete LVEF recovery for the combination of opposite LVEDVI/LGE negativity and enlarged LVEDVI/LGE positivity were 94% and 8%, respectively. The CMR-based prediction model of complete LVEF recovery can be used to perform upfront stratification in atrial tachyarrhythmia-related LVEF impairment.


Subject(s)
Contrast Media , Gadolinium , Humans , Magnetic Resonance Imaging, Cine , Magnetic Resonance Spectroscopy , Predictive Value of Tests , Stroke Volume , Tachycardia , Ventricular Function, Left
12.
Europace ; 24(10): 1617-1626, 2022 10 13.
Article in English | MEDLINE | ID: mdl-35726877

ABSTRACT

AIMS: Data on safety and efficacy of a non-fasting strategy in minimal invasive cardiac procedures are lacking. We assessed a non-fasting strategy compared with a fasting strategy regarding patient's well-being and safety in elective cardiac implantable electronic device (CIED) procedures. METHODS AND RESULTS: In this randomized, single-blinded clinical trial, 201 patients (non-fasting = 100, fasting = 101) with a mean age of 72.0 ± 11.6 years (66.7% male) were assigned to a non-fasting strategy (solids/fluids allowed up to 1 h) or a fasting strategy (at least 6 h no solids and 2 h no fluids) before the procedure and analysed on an intention-to-treat basis. The co-primary outcomes were patients' well-being scores (based on numeric rating scale, 0-10) and incidence of intra-procedural food-related adverse events, including vomiting, perioperative pulmonary aspiration, and emergency intubation. Renal, haematological, and metabolic blood parameters and 30-day follow-up data were gathered. The summed pre-procedural patients' well-being score was significantly lower in the non-fasting group [non-fasting: 13.1 ± 9.6 vs. fasting: 16.5 ± 11.4, 95% confidence interval (CI) of mean difference (MD) -6.35 to -0.46, P = 0.029], which was mainly driven by significantly lower scores for hunger and tiredness in the non-fasting group (non-fasting vs. fasting; hunger: 0.9 ± 1.9 vs. 3.1 ± 3.2, 95% CI of MD -2.86 to -1.42, P < 0.001; tiredness: 1.6 ± 2.3 vs. 2.6 ± 2.7, 95% CI of MD -1.68 to -0.29, P = 0.023). No intra-procedural food-related adverse events were observed. Relevant blood parameters and 30-day follow-up did not show significant differences. CONCLUSION: These results showed that a non-fasting strategy is beneficial to a fasting one regarding patient's well-being and comparable in terms of safety for CIED procedures (NCT04389697).


Subject(s)
Defibrillators, Implantable , Pacemaker, Artificial , Aged , Aged, 80 and over , Defibrillators, Implantable/adverse effects , Electronics , Female , Humans , Incidence , Male , Middle Aged
13.
Herz ; 47(2): 123-128, 2022 Apr.
Article in English | MEDLINE | ID: mdl-35257191

ABSTRACT

Catheter ablation of atrial fibrillation (AF) is the most effective rhythm control strategy and its role in the treatment of AF patients has been strengthened by recent guidelines. An increasing AF prevalence and the resulting demands on interventional electrophysiology call for improved resource allocation through both technical innovations and streamlined workflows and patient pathways. Same-day discharge is already established in the context of other electrophysiological interventions; however, its broad implementation in the practice of AF ablation is pending for several reasons, despite the fact that the body of evidence is growing and the majority of reports propagate early discharge to be feasible and safe under certain conditions. This review article is intended to provide an overview of the existing data, classify these into the specific study context, and to show limitations and open questions.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Atrial Fibrillation/surgery , Catheter Ablation/methods , Feasibility Studies , Humans , Patient Discharge , Pulmonary Veins/surgery , Treatment Outcome
14.
Europace ; 23(3): 409-420, 2021 03 08.
Article in English | MEDLINE | ID: mdl-33253376

ABSTRACT

AIMS: Conventional His bundle pacing (HBP) can be technically challenging and fluoroscopy-intense, particularly in patients with His-Purkinje conduction disease (HPCD). Three-dimensional electroanatomical mapping (EAM) facilitates non-fluoroscopic lead navigation and HB electrogram mapping. We sought to assess the procedural outcome of routine EAM-guided HBP compared with conventional HBP in a real-world population and evaluate the feasibility and safety of EAM-guided HBP in patients with HPCD. METHODS AND RESULTS: We included 58 consecutive patients (72 ± 13 years; 71% male) who underwent an attempt to conventional (EAM- group; n = 29) or EAM-guided (EAM+ group; n = 29) HBP between June 2019 and April 2020. The centre's learning curve was initially determined (n = 40 cases) to define the conventional control group and minimize outcome bias favouring EAM-guided HBP. His bundle pacing was successful in 26 patients (90%) in the EAM+ and 27 patients (93%) in the EAM- group (P = 0.64). The procedure time was 90 (73-135) and 110 (70-130) min, respectively (P = 0.89). The total fluoroscopy time [0.7 (0.5-1.4) vs. 3.3 (1.4-6.5) min; P < 0.001] and fluoroscopy dose [21.9 (9.1-47.7) vs. 78.6 (27.2-144.9) cGycm2; P = 0.001] were significantly lower in the EAM+ than EAM- group. There were no significant differences between groups in His capture threshold (1.2 ± 0.6 vs. 1.4 ± 1.0 V/1.0 ms; P = 0.33) and paced QRS duration (113 ± 15 vs. 113 ± 17 ms; P = 0.89). In patients with HPCD, paced QRS duration was similar in both groups (121 ± 15 vs. 123 ± 12 ms; P = 0.77). The bundle branch-block recruitment threshold tended to be lower in the EAM+ than EAM- group (1.3 ± 0.7 vs. 1.8 ± 1.2 V/1.0 ms; P = 0.31). No immediate procedure-related complications occurred. One patient (2%) experienced lead dislodgement during 4-week follow-up. CONCLUSION: Implementation of routine EAM-guided HBP lead implantation is feasible and safe in a real-world cohort of patients with and without HPCD and results in a tremendous reduction in radiation exposure without prolonging procedure time or increasing procedure-related complications.


Subject(s)
Bundle of His , Radiation Exposure , Cardiac Pacing, Artificial , Electrocardiography , Female , Fluoroscopy , Humans , Male , Treatment Outcome
15.
J Cardiovasc Magn Reson ; 22(1): 32, 2020 05 11.
Article in English | MEDLINE | ID: mdl-32389126

ABSTRACT

BACKGROUND: Data on the usefulness of cardiovascular magnetic resonance (CMR) imaging for clinical decision making in patients with an implanted cardioverter defibrillator (ICD) are scarce. The present study determined the impact of CMR imaging on diagnostic stratification and treatment decisions in ICD patients presenting with electrical instability or progressive heart failure symptoms. METHODS: 212 consecutive ICD patients underwent 1.5 T CMR combining diagnostic imaging modules tailored to the individual clinical indication (ventricular function assessment, myocardial tissue characterization, adenosine stress-perfusion, 3D-contrast-enhanced angiography); four CMR examinations (4/212, 2%) were excluded due to non-diagnostic CMR image quality. The resultant change in diagnosis or clinical management was determined in the overall population and compared between ICD patients for primary (115/208, 55%) or secondary prevention (93/208, 45%). Referral indication consisted of documented ventricular tachycardia, inadequate device therapy or progressive heart failure symptoms. RESULTS: Overall, CMR imaging data changed diagnosis in 40% (83/208) with a significant difference between primary versus secondary prevention ICD patients (37/115, 32% versus 46/93, 49%, respectively; p = 0.01). The information gain from CMR led to an overall change in treatment in 21% (43/208) with a similar distribution in primary versus secondary prevention ICD patients (25/115,22% versus 18/93,19%, p = 0.67). The effect on treatment change was highest in patients initially scheduled for ventricular tachycardia ablation procedure (18/141, 13%) with revision of the treatment plan to medical therapy or coronary revascularization. CONCLUSIONS: CMR imaging in ICD patients presenting with electrical instability or worsening heart failure symptoms provided diagnostic or management-changing information in a considerable proportion (40% and 21%, respectively).


Subject(s)
Death, Sudden, Cardiac/prevention & control , Defibrillators, Implantable , Electric Countershock/instrumentation , Heart Failure/therapy , Magnetic Resonance Imaging, Cine , Tachycardia, Ventricular/therapy , Aged , Catheter Ablation , Clinical Decision-Making , Disease Progression , Female , Heart Failure/diagnostic imaging , Heart Failure/physiopathology , Humans , Male , Middle Aged , Predictive Value of Tests , Primary Prevention , Secondary Prevention , Tachycardia, Ventricular/diagnostic imaging , Tachycardia, Ventricular/physiopathology , Time Factors , Treatment Outcome , Ventricular Function, Left
16.
Pacing Clin Electrophysiol ; 43(11): 1325-1332, 2020 11.
Article in English | MEDLINE | ID: mdl-32909622

ABSTRACT

INTRODUCTION: Cardiac perforation is a rare complication of cardiac implantable electronic device (CIED) implantation. Transvenous revision of perforated leads is associated with the risk of cardiac tamponade and death. Little is known about periprocedural complications and outcome of these patients. METHODS AND RESULTS: All patients referred to our department with evidence or suspicion of cardiac perforation following CIED implantation underwent chest X-ray, transthoracic echocardiography, device interrogation, and, if necessary, a cardiac computed tomography (CT)-scan to diagnose lead perforation and associated complications. Transvenous lead revision (TLR) was performed in all patients with evidence of lead perforation. Patient characteristics, procedural complications, and outcome were recorded and analyzed. Fifty-six patients (75 ± 10 years, 43% male) were diagnosed with cardiac perforation, 34 patients (61%) early within 30 days post-implantation, and 22 patients (39%) thereafter. The most frequent perforation site was the right ventricular (RV) apex (75%), followed by the RV free wall (16%) and the right atrial appendage (9%). A total of 16 patients (29%) presented with severe complications; 12 patients (21%) with pericardial effusion treated by pericardiocentesis before lead revision and four patients (7%) with hematothorax requiring drainage. Late perforations showed significantly more frequent cardiac tamponades (P = .041). TLR was performed without further complications in 54 patients (96%). None of the patients required surgical treatment or experienced in-hospital death. CONCLUSIONS: Cardiac perforation following CIED implantation is associated with severe complications in nearly one-third of the cases. Transvenous revision of the perforated lead can safely be performed with a very low complication rate.


Subject(s)
Defibrillators, Implantable/adverse effects , Device Removal/adverse effects , Heart Injuries/diagnostic imaging , Heart Injuries/etiology , Pacemaker, Artificial/adverse effects , Aged , Cardiac Tamponade/etiology , Female , Humans , Male , Risk Factors
17.
Heart Vessels ; 35(1): 104-109, 2020 Jan.
Article in English | MEDLINE | ID: mdl-31227877

ABSTRACT

The advantages of upgrade to cardiac resynchronisation therapy (CRT) have not been explored as carefully as the outcomes of de novo CRT implantations. Furthermore selection criteria for patients with the potential to benefit the most from this therapy are unknown. Therefore, we analyzed the long term outcome and its predictors in a real-world cohort receiving a CRT upgrade from previous pacemaker (PM) and defibrillator devices (ICD). We analyzed 86 patients (mean age 68 ± 9 years; 89% male) undergoing CRT upgrade procedures. Response to CRT as well as long term patient outcome was analyzed. NYHA class improved in majority of the patients during short term period (61%), and this trend remained constant during long term follow-up (54%). The observed all-cause mortality was 54% with mean survival of 49 ± 4 months. 11 patients underwent left ventricular assist device implantation or heart transplantation. In the multivariate analysis, only kidney function assessed by GFR (HR 0.97; 95% CI 0.95-0.99; p = 0.009) and LVEF (HR 0.92; 95% CI 0.87-0.97; p = 0.002) remain predictors for mortality. Patients who undergo an upgrade procedure to CRT demonstrate a significant response rate assessed by improvement in NYHA class, with initial baseline parameters such as LVEF and kidney function remaining significant predictors for mortality.


Subject(s)
Cardiac Pacing, Artificial , Cardiac Resynchronization Therapy Devices , Cardiac Resynchronization Therapy , Device Removal , Electric Countershock/instrumentation , Heart Failure/therapy , Pacemaker, Artificial , Aged , Cardiac Pacing, Artificial/adverse effects , Cardiac Pacing, Artificial/mortality , Cardiac Resynchronization Therapy/adverse effects , Cardiac Resynchronization Therapy/mortality , Cause of Death , Defibrillators, Implantable , Electric Countershock/adverse effects , Electric Countershock/mortality , Female , Heart Failure/diagnosis , Heart Failure/mortality , Heart Failure/physiopathology , Humans , Male , Middle Aged , Recovery of Function , Retrospective Studies , Stroke Volume , Time Factors , Treatment Outcome , Ventricular Function, Left
18.
Eur Heart J ; 40(8): 663-671, 2019 02 21.
Article in English | MEDLINE | ID: mdl-30561633

ABSTRACT

This review summarizes the rationale and current scientific evidence for catheter ablation in patients with atrial fibrillation and concomitant heart failure, puts it in context with recent practice recommendations, and discusses emerging technologies and future directions.


Subject(s)
Atrial Fibrillation/surgery , Catheter Ablation , Heart Failure/complications , Atrial Fibrillation/complications , Atrial Fibrillation/drug therapy , Heart Failure/physiopathology , Humans , Kaplan-Meier Estimate , Randomized Controlled Trials as Topic , Stroke Volume , Ventricular Dysfunction, Left
19.
Heart Lung Circ ; 29(1): 69-85, 2020 Jan.
Article in English | MEDLINE | ID: mdl-31262618

ABSTRACT

INTRODUCTION: Atrial fibrillation (AF) has been recognised as the most prevalent sustained arrhythmia. Recently, a growing body of evidence has suggested that AF might be involved in the progression of cognitive impairment (CIM), potentially extending into types of dementia. Accordingly, the purpose of the present study was to summarise the findings of investigations examining association between AF and cognitive function as well as highlighting the possible causes of discrepancy between the findings and reviewing the probable mechanisms of CIM in patients affected with AF. METHODS: A systematic search in the literature was conducted in the databases of PubMed, Scopus, Cochrane Library, and Google Scholar with no language restrictions, using specified search terms to identify studies published between 1 January 1990 and 1 April 2018. Then, study designs, participant information, diagnostic approaches used for cognitive assessments, and incidence/prevalence rates of CIM and/or dementia were assessed. RESULTS: Out of the initial 2,364 articles retrieved, a total number of 40 studies were selected for data collection. Most studies had suggested a significant relationship between AF and CIM. In this regard, cerebral hypo-perfusion, altered cerebral blood flow, cerebral micro-bleeds, micro-emboli, vascular inflammation, cerebral small vessel diseases, vascular inflammation, and genetic factors were considered as the possible mechanisms of CIM in patients suffering from AF. It seemed that differences in study settings and designs, variations of diagnostic tools for CIM and AF, as well as underlying conditions such as age groups, concurrent chronic diseases, and therapeutic interventions for AF might be amongst probable factors justifying the diversity of findings across the selected articles. CONCLUSION: Although evidence is much more directed towards an association between AF and CIM, the role of AF in CIM needs to be confirmed in-depth via longer prospective and cohort studies at larger scales using accurate neuropsychological and cognitive function assessments. Moreover, the mechanisms involved in the relationship between AF and Alzheimer's disease (AD) require further studies. To conclude, the effect of different therapeutic strategies of AF on CIM should be investigated in more clinical trials.


Subject(s)
Alzheimer Disease , Atrial Fibrillation , Cerebrovascular Disorders , Cognitive Dysfunction , Alzheimer Disease/etiology , Alzheimer Disease/physiopathology , Atrial Fibrillation/complications , Atrial Fibrillation/physiopathology , Cerebrovascular Disorders/etiology , Cerebrovascular Disorders/physiopathology , Cognitive Dysfunction/etiology , Cognitive Dysfunction/physiopathology , Humans
20.
J Cardiovasc Electrophysiol ; 30(12): 2767-2772, 2019 12.
Article in English | MEDLINE | ID: mdl-31626352

ABSTRACT

BACKGROUND: The significance of the inducibility of atrial fibrillation (AF) after pulmonary vein isolation (PVI) in patients with AF remains disputable and polarizing. Therefore, we investigated the prognostic value of the inducibility of AF on long-term outcome after PVI in patients without low-voltage left atrial (LA) substrate. METHODS: Two hundred forty-five patients (mean age 59+/-9years, 72% male) without LA low-voltage areas (defined as electrogram amplitudes <0.5 mV) undergoing first PVI procedure were included in the study. Following successful PVI, inducibility was assessed by burst pacing from coronary sinus with a cycle length (CL) of 300, 250, and 200 ms or the shortest CL resulting in 1:1 atrial capture. During the follow-up period of up to 3 years, the rhythm outcome was monitored by serial 7-days Holter electrocardiogram. RESULTS: AF was induced in 38 patients (16%). Atypical atrial flutter was observed in six patients (2%), while typical flutter in three cases (1%). Within the first 3 months, early recurrence was diagnosed in 39 patients (16%), while late recurrence was detected in 58 patients (24%) after a mean AF free survival of 28 ± 1 months. While there was no impact on early recurrence, AF inducibility affected long-term recurrence (31 ± 1 vs 23 ± 3 months; P = .001). In multivariate analysis, AF inducibility (hazard ratio [HR] 2.14; 95% confidence interval [CI], 1.03-4.45; P = .041) and persistent type of AF (HR 2.17; 95%CI, 1.06-4.47; P = .034) were associated with late AF recurrence. CONCLUSION: In patients without low-voltage substrate undergoing PVI, AF inducibility is a significant predictor of long-term outcome. The pathomechanisms of this phenomenon must be further studied to be addressed by additional treatment.


Subject(s)
Atrial Fibrillation/surgery , Atrial Function, Left , Catheter Ablation , Heart Rate , Pulmonary Veins/surgery , Action Potentials , Aged , Atrial Fibrillation/diagnosis , Atrial Fibrillation/physiopathology , Atrial Flutter/diagnosis , Atrial Flutter/etiology , Atrial Flutter/physiopathology , Catheter Ablation/adverse effects , Disease-Free Survival , Electrocardiography, Ambulatory , Electrophysiologic Techniques, Cardiac , Female , Humans , Male , Middle Aged , Pulmonary Veins/physiopathology , Recurrence , Risk Factors , Time Factors
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