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1.
Europace ; 26(5)2024 May 02.
Article in English | MEDLINE | ID: mdl-38696675

ABSTRACT

AIMS: Contact force (CF)-sensing radiofrequency (RF) catheters with an ablation index have shown reproducible outcomes for the treatment of atrial fibrillation (AF) in large multicentre studies. A dual-energy (DE) focal CF catheter to deliver RF and unipolar/biphasic pulsed field ablation (PFA), integrated with a three-dimensional (3D) mapping system, can provide operators with additional flexibility. The SmartfIRE study assessed the safety and efficacy of this novel technology for the treatment of drug-refractory, symptomatic paroxysmal AF. Results at 3 months post-ablation are presented here. METHODS AND RESULTS: Pulmonary vein isolation (PVI) was performed using a DE focal, irrigated CF-sensing catheter with the recommendation of PFA at posterior/inferior and RF ablation at the anterior/ridge/carina segments. Irrespective of energy, a tag size of 3 mm; an inter-tag distance ≤6 mm; a target index of 550 for anterior, roof, ridge, and carina; and a target index of 400 for posterior and inferior were recommended. Cavotricuspid isthmus ablation was permitted in patients with documented typical atrial flutter. The primary effectiveness endpoint was acute procedural success. The primary safety endpoint was the rate of primary adverse events (PAEs) within 7 days of the procedure. A prespecified patient subset underwent oesophageal endoscopy (EE; 72 h post-procedure), neurological assessment (NA; pre-procedure and discharge), and cardiac computed tomography (CT)/magnetic resonance angiogram (MRA) imaging (pre-procedure and 3 months post-procedure) for additional safety evaluation, and a mandatory remapping procedure (Day 75 ± 15) for PVI durability assessment. Of 149 patients enrolled between February and June 2023, 140 had the study catheter inserted (safety analysis set) and 137 had ablation energy delivered (per-protocol analysis set). The median (Q1/Q3) total procedure and fluoroscopy times were 108.0 (91.0/126.0) and 4.2 (2.3/7.7) min (n = 137). The acute procedural success rate was 100%. First-pass isolation was achieved in 89.1% of patients and 96.8% of veins. Cavotricuspid isthmus ablations were successfully performed in 12 patients [pulsed field (PF) only: 6, RF only: 5, and RF/PF: 1]. The PAE rate was 4.4% [6/137 patients; 2 pulmonary vein (PV) stenoses, 2 cardiac tamponades/perforations, 1 stroke, and 1 pericarditis]. No coronary artery spasm was reported. No oesophageal lesion was seen in the EE subset (0/31, 0%). In the NA subset (n = 30), microemboli lesions were identified in 2 patients (2/30, 6.7%), both of which were resolved at follow-up; only 1 was symptomatic (silent cerebral lesion, 3.3%). In the CT/MRA subset (n = 30), severe PV narrowing (of >70%) was detected in 2 patients (2/30, 6.7%; vein level 2/128, 1.6%), of whom 1 underwent dilatation and stenting and 1 was asymptomatic; both were associated with high index values and a small inter-tag distance. In the PV durability subset (n = 30), 100/115 treated PVs (87%) were durably isolated and 18/30 patients (60.0%) had all PVs durably isolated. CONCLUSION: A DE focal CF catheter with 3D mapping integration showed a 100% acute success rate with an acceptable safety profile in the treatment of paroxysmal AF. Prespecified 3-month remapping showed notable PVI durability. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05752487.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Humans , Pulmonary Veins/surgery , Atrial Fibrillation/surgery , Atrial Fibrillation/physiopathology , Male , Female , Catheter Ablation/methods , Catheter Ablation/instrumentation , Middle Aged , Treatment Outcome , Aged , Imaging, Three-Dimensional , Cardiac Catheters , Time Factors , Equipment Design , Prospective Studies , Recurrence
2.
Circulation ; 2024 May 14.
Article in English | MEDLINE | ID: mdl-38742491

ABSTRACT

BACKGROUND: Diffuse coronary artery disease (CAD) impacts the safety and efficacy of percutaneous coronary intervention (PCI). Pathophysiological CAD patterns can be quantified using fractional flow reserve (FFR) pullbacks incorporating the pullback pressure gradient (PPG) calculation. This study aimed to establish the capacity of PPG to predict optimal revascularisation and procedural outcomes. METHODS: This prospective, investigator-initiated, single-arm, multicentre study enrolled patients with at least one epicardial lesion with an FFR ≤ 0.80 scheduled for PCI. Manual FFR pullbacks were employed to calculate PPG. The primary outcome of optimal revascularisation was defined as a post-PCI FFR ≥ 0.88. RESULTS: 993 patients with 1044 vessels were included. The mean FFR was 0.68 ± 0.12, PPG 0.62 ± 0.17, and post-PCI FFR 0.87 ± 0.07. PPG was significantly correlated with the change in FFR after PCI (r=0.65, 95% CI 0.61-0.69, p<0.001) and demonstrated excellent predicted capacity for optimal revascularisation (AUC 0.82, 95% CI 0.79-0.84, p<0.001). Conversely, FFR alone did not predict revascularisation outcomes (AUC 0.54, 95% CI 0.50-0.57). PPG influenced treatment decisions in 14% of patients, redirecting them from PCI to alternative treatment modalities. Periprocedural myocardial infarction occurred more frequently in patients with low PPG (<0.62) compared to those with focal disease (OR 1.71, 95% CI: 1.00-2.97). CONCLUSIONS: Pathophysiological CAD patterns distinctly affect the safety and effectiveness of PCI. The PPG showed an excellent predictive capacity for optimal revascularisation and demonstrated added value compared to a FFR measurement.

3.
Circ Arrhythm Electrophysiol ; : e012667, 2024 Apr 24.
Article in English | MEDLINE | ID: mdl-38655693

ABSTRACT

BACKGROUND: We previously presented the safety and early efficacy of inspIRE study (Pulsed-Field Ablation (PFA) System for the Treatment of Paroxysmal Atrial Fibrillation by Irreversible Electroporation). With the study's conclusion, we report the outcomes of the full pivotal study cohort, with an additional analysis of predictors of success. METHODS: InspIRE was a prospective, multicenter, single-arm clinical trial of drug-refractory paroxysmal atrial fibrillation. Pulmonary vein isolation was performed with a variable-loop circular catheter integrated with a 3-dimensional mapping system. Follow-up with 24-hour Holter was at 3, 6, and 12 months, as well as remote rhythm monitoring: weekly from 3 to 5 months, monthly from 6 to 12 months, and for symptoms. The primary effectiveness end point (PEE) was acute pulmonary vein isolation plus freedom from any atrial arrhythmia at 12 months. Additional subanalyses report predictors of PEE success. RESULTS: The patient cohort included 186 patients: aged 59±10 years, female 30%, and CHA2DS2-VASc 1.3±1.2. The previously reported primary adverse event rate was 0%. One serious procedure-related adverse event, urinary retention, was reported. The PEE was achieved in 75.6% (95% CI, 69.5%-81.8%). The clinical success of freedom from symptomatic recurrence was 81.7% (95% CI, 76.1%-87.2%). Simulating a monitoring method used in standard real-world practice (without protocol-driven remote rhythm monitoring), this translates to a freedom from all and symptomatic recurrence of 85.8% (95% CI, 80.8%-90.9%) or 94.0% (95% CI, 90.6%-97.5%), respectively. Multivariate analyses revealed that left ventricular ejection fraction ≥60% (adjusted odds ratio, 0.30) and patients receiving ≥48 PFA applications (adjusted odds ratio, 0.28) were independent predictors of PEE success. Moreover, PEE success was 79.2% in patients who received ≥12 PFA applications/vein compared with 57.1% in patients receiving fewer PFA applications. CONCLUSIONS: The inspIRE study confirms the safety and effectiveness of pulmonary vein isolation using the novel 3-dimensional mapping integrated circular loop catheter. An optimal number of PFA applications (≥48 total or ≥12 per vein) resulted in an improved 1-year success rate of ≈80%. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04524364.

4.
Europace ; 26(4)2024 Mar 30.
Article in English | MEDLINE | ID: mdl-38582974

ABSTRACT

AIMS: The ultra-low-temperature cryoablation (ULTC) ablation system using -196°C N2 cryogen has been reported to create lesions with freeze duration-dependent depth titratable to over 10 mm with minimum attenuation by scar. Cryocure-VT (NCT04893317) was a first-in-human clinical trial evaluating the safety and efficacy of a novel, purpose-built ULTC catheter in endocardial ablation of scar-dependent ventricular tachycardias (VTs). METHODS AND RESULTS: This prospective, multi-centre study enrolled patients referred for de novo or second ablations of recurrent monomorphic VT of both ischaemic and non-ischaemic aetiologies. Primary safety and efficacy endpoints of the study were freedom from device- or procedure-related major adverse events (MAEs) up to 30 days post-ablation, acute non-inducibility of clinical VTs at the end of the procedure, and freedom from sustained VT or implantable defibrillator intervention at 6 months. Ultra-low-temperature cryoablation was performed in 64 patients (age 67 ± 11 years, 78% ischaemic, ejection fraction = 35 ± 10%) at 9 centres. The primary acute effectiveness endpoint was achieved in 94% (51/54) of patients in whom post-ablation induction was attempted. There were no protocol-defined MAEs; four procedure-related serious adverse events resolved without clinical sequelae. At 6-month follow-up, 38 patients (60.3%) remained VT-free, and freedom from defibrillator shock was 81.0%, with no significant difference between ischaemic and non-ischaemic cohorts. In 47 patients with defibrillator for at least 6 months prior to the ablation, the VT burden was reduced from median of 4, inter-quartile range (IQR, 1-9) to 0, IQR (0-2). CONCLUSION: In this first-in-human multi-centre experience, endocardial ULTC ablation of monomorphic VT appears safe and effective in patients with both ischaemic-cardiomyopathy and non-ischaemic-cardiomyopathy. CLINICAL TRIAL REGISTRATION: NCT04893317.


Subject(s)
Cardiomyopathies , Catheter Ablation , Cryosurgery , Tachycardia, Ventricular , Aged , Humans , Middle Aged , Cardiomyopathies/complications , Cardiomyopathies/diagnosis , Cardiomyopathies/surgery , Catheter Ablation/adverse effects , Cicatrix/complications , Cryosurgery/adverse effects , Prospective Studies , Tachycardia, Ventricular/diagnosis , Tachycardia, Ventricular/etiology , Tachycardia, Ventricular/surgery , Temperature , Treatment Outcome
5.
Article in English | MEDLINE | ID: mdl-38609733

ABSTRACT

In the last three decades, ablation of atrial fibrillation (AF) has become an evidence-based safe and efficacious treatment for managing the most common cardiac arrhythmia. In 2007, the first joint expert consensus document was issued, guiding healthcare professionals involved in catheter or surgical AF ablation. Mounting research evidence and technological advances have resulted in a rapidly changing landscape in the field of catheter and surgical AF ablation, thus stressing the need for regularly updated versions of this partnership which were issued in 2012 and 2017. Seven years after the last consensus, an updated document was considered necessary to define a contemporary framework for selection and management of patients considered for or undergoing catheter or surgical AF ablation. This consensus is a joint effort from collaborating cardiac electrophysiology societies, namely the European Heart Rhythm Association, the Heart Rhythm Society (HRS), the Asia Pacific HRS, and the Latin American HRS.

6.
Europace ; 26(4)2024 Mar 30.
Article in English | MEDLINE | ID: mdl-38591838

ABSTRACT

AIMS: Recent trial data demonstrate beneficial effects of active rhythm management in patients with atrial fibrillation (AF) and support the concept that a low arrhythmia burden is associated with a low risk of AF-related complications. The aim of this document is to summarize the key outcomes of the 9th AFNET/EHRA Consensus Conference of the Atrial Fibrillation NETwork (AFNET) and the European Heart Rhythm Association (EHRA). METHODS AND RESULTS: Eighty-three international experts met in Münster for 2 days in September 2023. Key findings are as follows: (i) Active rhythm management should be part of the default initial treatment for all suitable patients with AF. (ii) Patients with device-detected AF have a low burden of AF and a low risk of stroke. Anticoagulation prevents some strokes and also increases major but non-lethal bleeding. (iii) More research is needed to improve stroke risk prediction in patients with AF, especially in those with a low AF burden. Biomolecules, genetics, and imaging can support this. (iv) The presence of AF should trigger systematic workup and comprehensive treatment of concomitant cardiovascular conditions. (v) Machine learning algorithms have been used to improve detection or likely development of AF. Cooperation between clinicians and data scientists is needed to leverage the potential of data science applications for patients with AF. CONCLUSIONS: Patients with AF and a low arrhythmia burden have a lower risk of stroke and other cardiovascular events than those with a high arrhythmia burden. Combining active rhythm control, anticoagulation, rate control, and therapy of concomitant cardiovascular conditions can improve the lives of patients with AF.


Subject(s)
Atrial Fibrillation , Stroke , Humans , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/epidemiology , Stroke/etiology , Stroke/prevention & control , Risk , Hemorrhage , Anticoagulants/therapeutic use
8.
Europace ; 26(4)2024 Mar 30.
Article in English | MEDLINE | ID: mdl-38587017

ABSTRACT

In the last three decades, ablation of atrial fibrillation (AF) has become an evidence-based safe and efficacious treatment for managing the most common cardiac arrhythmia. In 2007, the first joint expert consensus document was issued, guiding healthcare professionals involved in catheter or surgical AF ablation. Mounting research evidence and technological advances have resulted in a rapidly changing landscape in the field of catheter and surgical AF ablation, thus stressing the need for regularly updated versions of this partnership which were issued in 2012 and 2017. Seven years after the last consensus, an updated document was considered necessary to define a contemporary framework for selection and management of patients considered for or undergoing catheter or surgical AF ablation. This consensus is a joint effort from collaborating cardiac electrophysiology societies, namely the European Heart Rhythm Association, the Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, and the Latin American Heart Rhythm Society .


Subject(s)
Atrial Fibrillation , Catheter Ablation , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Latin America , Treatment Outcome , Catheters , Asia , Catheter Ablation/adverse effects , Catheter Ablation/methods
10.
Article in English | MEDLINE | ID: mdl-38499825

ABSTRACT

BACKGROUND: Cardioneuroablation has been emerging as a potential treatment alternative in appropriately selected patients with cardioinhibitory vasovagal syncope (VVS) and functional AV block (AVB). However the majority of available evidence has been derived from retrospective cohort studies performed by experienced operators. METHODS: The Cardioneuroablation for the Management of Patients with Recurrent Vasovagal Syncope and Symptomatic Bradyarrhythmias (CNA-FWRD) Registry is a multicenter prospective registry with cross-over design evaluating acute and long-term outcomes of VVS and AVB patients treated by conservative therapy and CNA. RESULTS: The study is a prospective observational registry with cross-over design for analysis of outcomes between a control group (i.e., behavioral and medical therapy only) and intervention group (Cardioneuroablation). Primary and secondary outcomes will only be assessed after enrollment in the registry. The follow-up period will be 3 years after enrollment. CONCLUSIONS: There remains a lack of prospective multicentered data for long-term outcomes comparing conservative therapy to radiofrequency CNA procedures particularly for key outcomes including recurrence of syncope, AV block, durable impact of disruption of the autonomic nervous system, and long-term complications after CNA. The CNA-FWRD registry has the potential to help fill this information gap.

11.
Eur Heart J ; 45(11): 895-911, 2024 Mar 14.
Article in English | MEDLINE | ID: mdl-38441886

ABSTRACT

Atrial secondary tricuspid regurgitation (A-STR) is a distinct phenotype of secondary tricuspid regurgitation with predominant dilation of the right atrium and normal right and left ventricular function. Atrial secondary tricuspid regurgitation occurs most commonly in elderly women with atrial fibrillation and in heart failure with preserved ejection fraction in sinus rhythm. In A-STR, the main mechanism of leaflet malcoaptation is related to the presence of a significant dilation of the tricuspid annulus secondary to right atrial enlargement. In addition, there is an insufficient adaptive growth of tricuspid valve leaflets that become unable to cover the enlarged annular area. As opposed to the ventricular phenotype, in A-STR, the tricuspid valve leaflet tethering is typically trivial. The A-STR phenotype accounts for 10%-15% of clinically relevant tricuspid regurgitation and has better outcomes compared with the more prevalent ventricular phenotype. Recent data suggest that patients with A-STR may benefit from more aggressive rhythm control and timely valve interventions. However, little is mentioned in current guidelines on how to identify, evaluate, and manage these patients due to the lack of consistent evidence and variable definitions of this entity in recent investigations. This interdisciplinary expert opinion document focusing on A-STR is intended to help physicians understand this complex and rapidly evolving topic by reviewing its distinct pathophysiology, diagnosis, and multi-modality imaging characteristics. It first defines A-STR by proposing specific quantitative criteria for defining the atrial phenotype and for discriminating it from the ventricular phenotype, in order to facilitate standardization and consistency in research.


Subject(s)
Atrial Fibrillation , Heart Failure , Tricuspid Valve Insufficiency , Humans , Female , Aged , Tricuspid Valve Insufficiency/etiology , Tricuspid Valve Insufficiency/complications , Heart Atria/diagnostic imaging , Tricuspid Valve/diagnostic imaging , Atrial Fibrillation/diagnosis , Atrial Fibrillation/etiology , Atrial Fibrillation/therapy
12.
J Cardiovasc Electrophysiol ; 35(5): 886-894, 2024 May.
Article in English | MEDLINE | ID: mdl-38433316

ABSTRACT

INTRODUCTION: Through systematic scientific rigor, the CLOSE guided workflow was developed and has been shown to improve pulmonary vein isolation durability. However, this technique was developed at a time when using power-controlled ablation catheters with conventional power ranges was the norm. There has been increased adoption of a high-power and very high-power short-duration ablation practice propelled by the availability of the temperature-controlled radiofrequency QDOT MICRO catheter. METHODS: There are fundamental differences in biophysics between very high-powered temperature guided ablation and conventional ablation strategy that may impact patient outcomes. The catheter's design and ablation modes offer flexibility in technique while accommodating the individual operator's clinical discretion and preference to deliver a durable, transmural, and contiguous lesion set. RESULTS: Here, we provide recommendations for 3 different workflows using the QDOT MICRO catheter in a step-by-step manner for pulmonary vein isolation based on our cumulative experience as early adopters of the technology and the data available in the scientific literature. CONCLUSIONS: With standardization, temperature-controlled ablation with the QDOT MICRO catheter provides operators the flexibility of implementing different ablation strategies to ensure durable contiguous pulmonary vein isolation depending on patient characteristics.


Subject(s)
Atrial Fibrillation , Cardiac Catheters , Catheter Ablation , Equipment Design , Pulmonary Veins , Humans , Action Potentials , Atrial Fibrillation/surgery , Atrial Fibrillation/physiopathology , Atrial Fibrillation/diagnosis , Catheter Ablation/instrumentation , Heart Rate , Pulmonary Veins/surgery , Pulmonary Veins/physiopathology , Temperature , Time Factors , Treatment Outcome , Workflow
13.
Article in English | MEDLINE | ID: mdl-38448258

ABSTRACT

BACKGROUND: Left atrial appendage (LAA) occluder embolization is an infrequent but serious complication. OBJECTIVES: We aim to describe timing, management and clinical outcomes of device embolization in a multi-center registry. METHODS: Patient characteristics, imaging findings and procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes. RESULTS: Sixty-seven centers contributed data. Device embolization occurred in 108 patients. In 70.4 % of cases, it happened within the first 24 h of the procedure. The device was purposefully left in the LA and the aorta in two (1.9 %) patients, an initial percutaneous retrieval was attempted in 81 (75.0 %) and surgery without prior percutaneous retrieval attempt was performed in 23 (21.3 %) patients. Two patients died before a retrieval attempt could be made. In 28/81 (34.6 %) patients with an initial percutaneous retrieval attempt a second, additional attempt was performed, which was associated with a high mortality (death in patients with one attempt: 2.9 % vs. second attempt: 21.4 %, p < 0.001). The primary outcome (bailout surgery, cardiogenic shock, stroke, TIA, and/or death) occurred in 47 (43.5 %) patients. Other major complications related to device embolization occurred in 21 (19.4 %) patients. CONCLUSIONS: The majority of device embolizations after LAA closure occurs early. A percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was unsuccessful. CONDENSED ABSTRACT: This dedicated multicenter registry examined timing, management, and clinical outcome of device embolization. Early embolization (70.4 %) was most frequent. As a first rescue attempt, percutaneous retrieval was preferred in 75.0 %, followed by surgical removal (21.3 %). In patients with a second retrieval attempt a higher mortality (death first attempt: 2.9 % vs. death second attempt: 24.1 %, p < 0.001) was observed. Mortality (10.2 %) and the major complication rate after device embolization were high.

14.
Pacing Clin Electrophysiol ; 47(4): 568-576, 2024 04.
Article in English | MEDLINE | ID: mdl-38407315

ABSTRACT

BACKGROUND: Clinical studies have demonstrated the safety, efficacy, and efficiency of VISITAG SURPOINT® (VS), which provides important lesion markers during catheter ablation (CA) of atrial fibrillation (AF). The present study evaluated the cost-effectiveness of CA with VS compared to CA without VS in AF from the publicly-funded German and Belgium healthcare perspectives. METHODS: We constructed a two-stage cost utility model that included a decision tree to simulate clinical events, costs, and utilities during the first year after the index procedure and a Markov model to simulate transitions between health states throughout a patient's lifetime. Model inputs included published literature, a meta-analysis of randomized controlled trials AF outcomes, and publicly available administrative data on costs. Deterministic and probabilistic sensitivity analyses were conducted to determine the robustness of the model. RESULTS: CA with VS was associated with lower per patient costs vs CA without VS (Germany: €3295 vs. €3936, Belgium: €3194 vs. €3814) and similar quality-adjusted life-years (QALYs) per patient (Germany: 5.35 vs. 5.34, Belgium: 5.68 vs. 5.67). CA with VS was the dominant ablation strategy (incremental cost-effectiveness ratios: Germany: €-52,455/QALY, Belgium: €-50,676/QALY). The model results were robust and not highly sensitive to variation to individual parameters with regard to QALYs or costs. Freedom from AF and procedure time had the greatest impact on model results, highlighting the importance of these outcomes in ablation. CONCLUSIONS: CA with VS resulted in cost savings and QALY gains compared to CA without VS, supporting the increased adoption of VS in CA in Germany and Belgium.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Humans , Atrial Fibrillation/surgery , Cost-Benefit Analysis , Catheter Ablation/methods , Quality-Adjusted Life Years , Belgium
15.
Europace ; 26(4)2024 Mar 30.
Article in English | MEDLINE | ID: mdl-38291925

ABSTRACT

A significant proportion of patients who suffer from atrial fibrillation (AF) and are in need of thromboembolic protection are not treated with oral anticoagulation or discontinue this treatment shortly after its initiation. This undertreatment has not improved sufficiently despite the availability of direct oral anticoagulants which are associated with less major bleeding than vitamin K antagonists. Multiple reasons account for this, including bleeding events or ischaemic strokes whilst on anticoagulation, a serious risk of bleeding events, poor treatment compliance despite best educational attempts, or aversion to drug therapy. An alternative interventional therapy, which is not associated with long-term bleeding and is as effective as vitamin K anticoagulation, was introduced over 20 years ago. Because of significant improvements in procedural safety over the years, left atrial appendage closure, predominantly achieved using a catheter-based, device implantation approach, is increasingly favoured for the prevention of thromboembolic events in patients who cannot achieve effective anticoagulation. This management strategy is well known to the interventional cardiologist/electrophysiologist but is not more widely appreciated within cardiology or internal medicine. This article introduces the devices and briefly explains the implantation technique. The indications and device follow-up are more comprehensively described. Almost all physicians who care for adult patients will have many with AF. This practical guide, written within guideline/guidance boundaries, is aimed at those non-implanting physicians who may need to refer patients for consideration of this new therapy, which is becoming increasingly popular.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Physicians , Stroke , Thromboembolism , Adult , Humans , Stroke/prevention & control , Stroke/complications , Left Atrial Appendage Closure , Consensus , Hemorrhage/chemically induced , Hemorrhage/prevention & control , Anticoagulants/adverse effects , Thromboembolism/etiology , Thromboembolism/prevention & control , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Vitamin K , Atrial Appendage/surgery , Treatment Outcome
16.
Eur Heart J ; 45(5): 346-365, 2024 Feb 01.
Article in English | MEDLINE | ID: mdl-38096587

ABSTRACT

The role of cardiac implantable electronic device (CIED)-related tricuspid regurgitation (TR) is increasingly recognized as an independent clinical entity. Hence, interventional TR treatment options continuously evolve, surgical risk assessment and peri-operative care improve the management of CIED-related TR, and the role of lead extraction is of high interest. Furthermore, novel surgical and interventional tricuspid valve treatment options are increasingly applied to patients suffering from TR associated with or related to CIEDs. This multidisciplinary review article developed with electrophysiologists, interventional cardiologists, imaging specialists, and cardiac surgeons aims to give an overview of the mechanisms of disease, diagnostics, and proposes treatment algorithms of patients suffering from TR associated with CIED lead(s) or leadless pacemakers.


Subject(s)
Defibrillators, Implantable , Pacemaker, Artificial , Rheumatic Heart Disease , Tricuspid Valve Insufficiency , Humans , Pacemaker, Artificial/adverse effects , Defibrillators, Implantable/adverse effects , Tricuspid Valve/diagnostic imaging , Tricuspid Valve/surgery , Tricuspid Valve Insufficiency/surgery , Tricuspid Valve Insufficiency/complications , Rheumatic Heart Disease/complications , Retrospective Studies
17.
J Cardiovasc Comput Tomogr ; 18(1): 62-68, 2024.
Article in English | MEDLINE | ID: mdl-38072710

ABSTRACT

BACKGROUND: Coronary computed tomography angiography (CCTA) -derived fractional flow reserve (FFRCT) is recommended to evaluate the functional consequences of obstructive coronary artery disease (OCAD). Real-world incremental impacts of FFRCT use still remains under debate. METHODS: 1601 patients with suspected OCAD on CCTA (>50 â€‹% stenosis), including 808 (50.5 â€‹%) patients evaluated by FFRCT, were included from a 2013-2021 registry. Propensity adjusted impacts of FFRCT use on rates of invasive coronary angiography (ICA), myocardial revascularization (MR) and post MR major adverse cardiac events (MACE) were reported, including a sensitivity analysis in severe OCAD (>70 â€‹% stenosis) (n â€‹= â€‹450). Accuracy of numerical and comprehensive FFRCT interpretations in selection of patients requiring a MR were also compared. RESULTS: 1160 (72,5 â€‹%) ICA, 559 (34.9 â€‹%) MR and 137 (24.5 â€‹%) post MR MACE occurred at 4.7 â€‹± â€‹1.9 years. FFRCT use was independently associated with decreased rate of ICA and MR (OR: 0.66; 95 â€‹% CI 0.53-0.83, p â€‹< â€‹0.001 and OR: 0.71; 95 â€‹% CI 0.58-0.88, p â€‹< â€‹0.01, respectively). Compared to the numerical interpretation, the FFRCT comprehensive assessment increased the ratio of MR per ICA (61.7 â€‹% vs 50.1 â€‹%, p â€‹< â€‹0.01) and was more accurate in selection of patients requiring MR. FFRCT reduced post MR MACE (OR: 0.64; 95 â€‹% CI 0.43-0.96, p â€‹< â€‹0.05). All these associations were no longer observed in severe OCAD. CONCLUSION: Implementing FFRCT in OCAD patients reduces ICA use, improves selection of patients requiring MR and reduces post MR MACE. However, these incremental values of FFRCT were no longer observed in severe OCAD.


Subject(s)
Coronary Artery Disease , Coronary Stenosis , Fractional Flow Reserve, Myocardial , Humans , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Prognosis , Constriction, Pathologic , Coronary Angiography/methods , Predictive Value of Tests , Computed Tomography Angiography , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/therapy , Coronary Vessels/diagnostic imaging
18.
Article in English | MEDLINE | ID: mdl-38092999

ABSTRACT

BACKGROUND: High-power short-duration (HPSD) ablation may improve the consistency and efficiency of pulmonary vein isolation (PVI). The novel QDOT Micro™ catheter (Biosense Webster, Inc.) with temperature feedback and microelectrodes aims to enhance PVI efficiency and safety. This study wants to evaluate the feasibility, safety, and efficiency of a standardized single-catheter workflow for PVI using QDOT (Q-FLOW). METHODS: The Q-FLOW includes single transeptal access, radiofrequency encircling of the PVs using a power of 50 W in a temperature/flow-controlled mode, and validation of the circles with microelectrodes. A 1:1 propensity-matched cohort of patients treated with conventional power-controlled ablation using a circular mapping catheter (CMC-FLOW) was used to compare procedural and clinical outcomes. RESULTS: A total of 150 consecutive atrial fibrillation patients (paroxysmal 67%, persistent 33%) were included. First-pass isolation rate was 86%. Procedural time, X-ray time, and dose were significantly lower for the Q-FLOW vs the CMC-FLOW (67.2 ± 17.9 vs 88.3 ± 19.2 min, P < 0.001; 3.0 ± 1.9 vs 5.0 ± 2.4 min, P < 0.001; 4.3 ± 1.9 vs 6.4 ± 2.3 Gycm2, P < 0.001). Complications were numerically but not significantly lower in the Q-FLOW group (2 [1.3%] vs 7 [4.7%], P = 0.091). There was no difference in arrhythmia recurrence at 12 months (atrial arrhythmia-free survival rate, 87.5% vs 84.4%, P = 0.565). CONCLUSION: A streamlined single-catheter workflow for PVI using QDOT was feasible and safe, resulting in a high rate of first-pass isolation and a low complication rate. The Q-FLOW further improved the efficiency of PVI compared to the standard CMC-FLOW, without difference in the 12-month outcome.

19.
JACC Case Rep ; 25: 102036, 2023 Nov 01.
Article in English | MEDLINE | ID: mdl-38094206

ABSTRACT

We report a case of a clinically asymptomatic patient with extreme P-wave separation on the electrocardiogram mimicking atrial tachycardia with atrioventricular block. The accurate examination of the patient, analysis of the electrocardiogram, and echocardiographic findings led to proper diagnosis, management, and treatment. (Level of Difficulty: Intermediate.).

20.
Circ Arrhythm Electrophysiol ; 16(11): e012043, 2023 11.
Article in English | MEDLINE | ID: mdl-37921006

ABSTRACT

BACKGROUND: In patients with persistent atrial fibrillation (PersAF), catheter ablation aiming for pulmonary vein isolation (PVI) is associated with moderate clinical effectiveness. We investigated the benefit of continuing previously ineffective class 1C or 3 antiarrhythmic drug therapy (ADT) in the setting of a standardized PVI-only ablation strategy. METHODS: In this multicenter, randomized controlled study, patients with PersAF (≥7 days and <12 months) despite ADT were prospectively randomized 1:1 to PVI with ADT continued versus discontinued beyond the blanking period (ADT ON versus ADT OFF). Standardized catheter ablation was performed aiming for durable isolation with stable, contiguous, and optimized radio frequency applications encircling the pulmonary veins (CLOSE protocol). Clinical visits and 1-to-7-day Holter were performed at 3, 6, and 12 months. The primary end point was any documented atrial tachyarrhythmia lasting >30 seconds beyond 3 months. Prospectively defined secondary end points included repeat ablations, unscheduled arrhythmia-related visits, and quality of life among groups. RESULTS: Of 200 PersAF patients, 98 were assigned to ADT OFF and 102 to ADT ON. The longest atrial fibrillation episode qualifying for PersAF was 28 (10-90) versus 30 (11-90) days. Clinical characteristics and procedural characteristics were similar. Recurrence of atrial tachyarrhythmia was comparable in both groups (20% OFF versus 21.2% ON). No differences were observed in repeat ablations and unscheduled arrhythmia-related visits. Marked improvement in quality of life was observed in both groups. CONCLUSIONS: In patients with PersAF, there is no benefit in continuing previously ineffective ADT beyond the blanking period after catheter ablation. The high success rate of PVI-only might be explained by the high rate of durable isolation after optimized PVI and the early stage of PersAF (POWDER-AF2). REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03437356.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Humans , Anti-Arrhythmia Agents/adverse effects , Atrial Fibrillation/diagnosis , Atrial Fibrillation/drug therapy , Atrial Fibrillation/surgery , Catheter Ablation/adverse effects , Catheter Ablation/methods , Furylfuramide , Powders/therapeutic use , Pulmonary Veins/surgery , Quality of Life , Recurrence , Tachycardia , Treatment Outcome , Prospective Studies
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