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Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.
Subject(s)
Atrial Fibrillation , Catheter Ablation , Humans , Atrial Fibrillation/surgery , Atrial Fibrillation/therapy , Female , Male , Middle Aged , Catheter Ablation/adverse effects , Catheter Ablation/methods , Aged , Treatment Outcome , Postoperative Complications/epidemiology , Postoperative Complications/etiologyABSTRACT
AIMS: A pulsed electric field (PF) energy source is a novel potential option for catheter ablation of ventricular arrhythmias (VAs) as it can create deeper lesions, particularly in scarred tissue. However, very limited data exist on its efficacy and safety. This prospective observational study reports the initial experience with VA ablation using focal PF. METHODS AND RESULTS: The study population consisted of 44 patients (16 women, aged 61 ± 14years) with either frequent ventricular premature complexes (VPCs, 48%) or scar-related ventricular tachycardia (VT, 52%). Ablation was performed using an irrigated 4 mm tip catheter and a commercially available PF generator. On average, 16 ± 15 PF applications (25 A) were delivered per patient. Acute success was achieved in 84% of patients as assessed by elimination of VPC or reaching non-inducibility of VT. In three cases (7%), a transient conduction system block was observed during PF applications remotely from the septum. Root analysis revealed that this event was caused by current leakage from the proximal shaft electrodes in contact with the basal interventricular septum. Acute elimination of VPC was achieved in 81% patients and non-inducibility of VT in 83% patients. At the 3-month follow-up, persistent suppression of the VPC was confirmed on Holter monitoring in 81% patients. In the VT group, the mean follow-up was 116 ± 75 days and a total of 52% patients remained free of any VA. CONCLUSION: Pulsed electric field catheter ablation of a broad spectrum of VA is feasible with acute high efficacy; however, the short-term follow-up is less satisfactory for patients with scar-related VT.
Subject(s)
Catheter Ablation , Tachycardia, Ventricular , Ventricular Premature Complexes , Humans , Female , Middle Aged , Male , Tachycardia, Ventricular/surgery , Tachycardia, Ventricular/physiopathology , Catheter Ablation/methods , Catheter Ablation/adverse effects , Treatment Outcome , Aged , Ventricular Premature Complexes/surgery , Ventricular Premature Complexes/physiopathology , Ventricular Premature Complexes/diagnosis , Prospective Studies , Cicatrix/etiology , Electrophysiologic Techniques, CardiacABSTRACT
OBJECTIVES: Current recommendations support surgical treatment of atrial fibrillation (AF) in patients indicated for cardiac surgery. These procedures are referred to as concomitant and may be carried out using radiofrequency energy or cryo-ablation. This study aimed to assess the electrophysiological findings in patients undergoing concomitant cryo-ablation. METHODS: Patients with non-paroxysmal AF undergoing coronary artery bypass grafting and/or valve repair/replacement were included in the trial if concomitant cryo-ablation was part of the treatment plan according to current guidelines. The patients reported in this study were assigned to undergo staged percutaneous radiofrequency catheter ablation (PRFCA), i.e., hybrid treatment, as a part of the SURHYB trial protocol. RESULTS: We analyzed 103 patients who underwent PRFCA 105 ± 35 days after surgery. Left and right pulmonary veins (PVs) were found isolated in 65 (63.1%) and 63 (61.2%) patients, respectively. The LA posterior wall isolation and mitral isthmus conduction block were found in 38 (36.9%) and 18 (20.0%) patients, respectively. Electrical reconnections (gaps) in the left PVs were more often localized superiorly than inferiorly (57.9% vs. 26.3%, P = 0.005) and anteriorly than posteriorly (65.8% vs. 31.6%, P = 0.003). Gaps in the right PVs were more equally distributed anteroposteriorly but dominated in superior segments (72.5% vs. 40.0%, P = 0.003). There was a higher number of gaps on the roof line compared to the inferior line (131 (67.2%) vs. 67 (42.2%), P < 0.001). Compared to epicardial cryo-ablation, endocardial was more effective in creating PVs and LA posterior wall isolation (P < 0.05). Cryo-ablation using nitrous oxide (N20) or argon (Ar) gas as cooling agents was similarly effective (P = NS). CONCLUSIONS: The effectiveness of surgical cryo-ablation in achieving transmural and durable lesions in the left atrium is surprisingly low. Gaps are located predominantly in the superior and anterior portions of the PVs and on the roof line. Endocardial cryo-ablation is more effective than epicardial ablation, irrespective of the cooling agent used.
Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Pulmonary Veins , Humans , Atrial Fibrillation/surgery , Cryosurgery/methods , Male , Female , Catheter Ablation/methods , Middle Aged , Aged , Pulmonary Veins/surgery , Treatment Outcome , Coronary Artery Bypass/methodsABSTRACT
Objectives: Cardiac arrhythmias predict poor outcome after myocardial infarction (MI). We studied if arrhythmia monitoring with an insertable cardiac monitor (ICM) can improve treatment and outcome. Design: BIO|GUARD-MI was a randomized, international open-label study with blinded outcome assessment. Setting: Tertiary care facilities monitored the arrhythmias, while the follow-up remained with primary care physicians. Participants: Patients after ST-elevation (STEMI) or non-ST-elevation MI with an ejection fraction >35% and a CHA2DS2-VASc score ≥4 (men) or ≥5 (women). Interventions: Patients were randomly assigned to receive or not receive an ICM in addition to standard post-MI treatment. Device-detected arrhythmias triggered immediate guideline recommended therapy changes via remote monitoring. Main outcome measures: MACE, defined as a composite of cardiovascular death or acute unscheduled hospitalization for cardiovascular causes. Results: 790 patients (mean age 71 years, 72% male, 51% non-STEMI) of planned 1,400 pts were enrolled and followed for a median of 31.6 months. At 2 years, 39.4% of the device group and 6.7% of the control group had their therapy adapted for an arrhythmia [hazard ratio (HR) = 5.9, P < 0.0001]. Most frequent arrhythmias were atrial fibrillation, pauses and bradycardia. The use of an ICM did not improve outcome in the entire cohort (HR = 0.84, 95%-CI: 0.65-1.10; P = 0.21). In secondary analysis, a statistically significant interaction of the type of infarction suggests a benefit in the pre-specified non-STEMI subgroup. Risk factor analysis indicates that this may be connected to the higher incidence of MACE in patients with non-STEMI. Conclusions: The burden of asymptomatic but actionable arrhythmias is large in post-infarction patients. However, arrhythmia monitoring with an ICM did not improve outcome in the entire cohort. Post-hoc analysis suggests that it may be beneficial in non-STEMI patients or other high-risk subgroups. Clinical Trial Registration: [https://www.clinicaltrials.gov/ct2/show/NCT02341534], NCT02341534.
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Background: Conduction system pacing (CSP), either as His bundle pacing (HBP) or as left bundle branch area pacing (LBBAP), may be superior to right ventricular apical or septal pacing. Objective: The study sought to present acute results for a new guiding catheter (Biotronik Selectra 3D) designed for CSP implantations of a retractable screw-in lead (Biotronik Solia S). Methods: The primary endpoint of the prospective, international nonrandomized BIO|MASTER.Selectra 3D study was freedom from catheter-related serious adverse device effects (SADEs) within 1 week of lead implantation. Results: Of 157 enrolled patients, CSP was achieved in 147 (93.6%) patients. No SADEs occurred within 7 days. LBBAP was achieved in 82 patients (45 as crossover from an HBP attempt) and HBP in 65 (44.2%) patients. In centers considering both HBP and LBBAP, the CSP implantation success approached 99%. Successful CSP implantations lasted on average â¼50 minutes (fluoroscopy â¼6 minutes). Most procedures (87.9%) needed only 1 catheter, even after switch from HBP to LBBAP. The catheter's handling was rated largely positive. In patients without bundle branch block, mean QRS duration increased from 106 ms (intrinsic) to 122 ms (CSP) (P = .001). In patients with bundle branch block, mean QRS duration decreased from 151 ms (intrinsic) to 137 ms (CSP) (P = .004). Conclusion: The Selectra 3D catheter is a valuable tool for HBP and LBBAP implantations of the stylet-supported pacemaker leads. When implanters considered both HBP and LBBAP, the success rate was â¼99%. Flexibility to change between different approaches may be advisable in heterogeneous and challenging areas, such as CSP implantations.
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AIMS: Data on the hybrid atrial fibrillation (AF) treatment are lacking in patients with structural heart disease undergoing concomitant CryoMaze procedures. The aim was to assess whether the timely pre-emptive catheter ablation would achieve higher freedom from AF or atrial tachycardia (AT) and be associated with better clinical outcomes than surgical ablation alone. METHODS AND RESULTS: The trial investigated patients with non-paroxysmal AF undergoing coronary artery bypass grafting and/or valve repair/replacement with mandatory concomitant CryoMaze procedure who were randomly assigned to undergo either radiofrequency catheter ablation [Hybrid Group (HG)] or no further treatment (Surgery Group). The primary efficacy endpoint was the first recurrence of AF/AT without class I or III antiarrhythmic drugs as assessed by implantable cardiac monitors. The primary clinical endpoint was a composite of hospitalization for arrhythmia recurrence, worsening of heart failure, cardioembolic event, or major bleeding. We analysed 113 and 116 patients in the Hybrid and Surgery Groups, respectively, with a median follow-up of 715 (IQR: 528-1072) days. The primary efficacy endpoint was significantly reduced in the HG [41.1% vs. 67.4%, hazard ratio (HR) = 0.38, 95% confidence interval (CI): 0.26-0.57, P < 0.001] as well as the primary clinical endpoint (19.9% vs. 40.1%, HR = 0.51, 95% CI: 0.29-0.86, P = 0.012). The trial groups did not differ in all-cause mortality (10.6% vs. 8.6%, HR = 1.17, 95%CI: 0.51-2.71, P = 0.71). The major complications of catheter ablation were infrequent (1.9%). CONCLUSION: Pre-emptively performed catheter ablation after the CryoMaze procedure was safe and associated with higher freedom from AF/AT and improved clinical outcomes.
Subject(s)
Atrial Fibrillation , Catheter Ablation , Tachycardia, Supraventricular , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Atrial Fibrillation/drug therapy , Treatment Outcome , Tachycardia, Supraventricular/surgery , Anti-Arrhythmia Agents/therapeutic use , Hemorrhage , Catheter Ablation/adverse effects , Catheter Ablation/methods , RecurrenceABSTRACT
AIMS: To predict worsening heart failure hospitalizations (WHFHs) in patients with implantable defibrillators and remote monitoring, the HeartInsight algorithm (Biotronik, Berlin, Germany) calculates a heart failure (HF) score combining seven physiologic parameters: 24â h heart rate (HR), nocturnal HR, HR variability, atrial tachyarrhythmia, ventricular extrasystoles, patient activity, and thoracic impedance. We compared temporal trends of the HF score and its components 12 weeks before a WHFH with 12-week trends in patients without WHFH, to assess whether trends indicate deteriorating HF regardless of alert status. METHODS AND RESULTS: Data from nine clinical trials were pooled, including 2050 patients with a defibrillator capable of atrial sensing, ejection fraction ≤ 35%, NYHA class II/III, no long-standing atrial fibrillation, and 369 WHFH from 259 patients. The mean HF score was higher in the WHFH group than in the no WHFH group (42.3 ± 26.1 vs. 30.7 ± 20.6, P < 0.001) already at the beginning of 12 weeks. The mean HF score further increased to 51.6 ± 26.8 until WHFH (+22% vs. no WHFH group, P = 0.003). As compared to the no WHFH group, the algorithm components either were already higher 12 weeks before WHFH (24â h HR, HR variability, thoracic impedance) or significantly increased until WHFH (nocturnal HR, atrial tachyarrhythmia, ventricular extrasystoles, patient activity). CONCLUSION: The HF score was significantly higher at, and further increased during 12 weeks before WHFH, as compared to the no WHFH group, with seven components showing different behaviour and contribution. Temporal trends of HF score may serve as a quantitative estimate of HF condition and evolution prior to WHFH.
Subject(s)
Defibrillators, Implantable , Heart Failure , Tachycardia, Ventricular , Humans , Hospitalization , Heart Failure/diagnosis , Heart Failure/therapy , Tachycardia, Ventricular/diagnosis , Tachycardia, Ventricular/therapy , Cardiac Complexes, PrematureABSTRACT
Background: Endocardial catheter ablation (CA) has limited long-term benefit for persistent and longstanding persistent atrial fibrillation (PersAF/LSPAF). We hypothesized hybrid epicardial-endocardial ablation (HA) would have superior effectiveness compared to CA, including repeat (rCA), in PersAF/LSPAF. Methods: CEASE-AF (NCT02695277) is a prospective, multi-center, randomized controlled trial. Nine hospitals in Poland, Czech Republic, Germany, United Kingdom, and the Netherlands enrolled eligible participants with symptomatic, drug refractory PersAF and left atrial diameter (LAD) > 4.0 cm or LSPAF. Randomization was 2:1 to HA or CA by an independent statistician and stratified by site. Treatment assignments were masked to the core rhythm monitoring laboratory. For HA, pulmonary veins (PV) and left posterior atrial wall were isolated with thoracoscopic epicardial ablation including left atrial appendage exclusion. Endocardial touch-up ablation was performed 91-180 days post-index procedure. For CA, endocardial PV isolation and optional substrate ablation were performed. rCA was permitted between days 91-180. Primary effectiveness was freedom from AF/atrial flutter/atrial tachycardia >30-s through 12-months absent class I/III anti-arrhythmic drugs except those not exceeding previously failed doses. It was assessed in the modified intention-to-treat (mITT) population who had the index procedure and follow-up data. Major complications were assessed in the ITT population who had the index procedure. Thirty-six month follow-up continues. Findings: Enrollment began November 20, 2015 and ended May 22, 2020. In 154 ITT patients (102 HA; 52 CA), 75% were male, mean age was 60.7 ± 7.9 years, mean LAD was 4.7 ± 0.4 cm, and 81% had PersAF. Primary effectiveness was 71.6% (68/95) in HA versus 39.2% (20/51) in CA (absolute benefit increase: 32.4% [95% CI 14.3%-48.0%], p < 0.001). Major complications through 30-days after index procedures plus 30-days after second stage/rCA were similar (HA: 7.8% [8/102] versus CA: 5.8% [3/52], p = 0.75). Interpretation: HA had superior effectiveness compared to CA/rCA in PersAF/LSPAF without significant procedural risk increase. Funding: AtriCure, Inc.
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Interventional electrophysiology offers a great variety of treatment options to patients suffering from symptomatic cardiac arrhythmia. Catheter ablation of supraventricular and ventricular tachycardia has globally evolved a cornerstone in modern arrhythmia management. Complex interventional electrophysiological procedures engaging multiple ablation tools have been developed over the past decades. Fluoroscopy enabled interventional electrophysiologist throughout the years to gain profound knowledge on intracardiac anatomy and catheter movement inside the cardiac cavities and hence develop specific ablation approaches. However, the application of X-ray technologies imposes serious health risks to patients and operators. To reduce the use of fluoroscopy during interventional electrophysiological procedures to the possibly lowest degree and to establish an optimal protection of patients and operators in cases of fluoroscopy is the main goal of modern radiation management. The present manuscript gives an overview of possible strategies of fluoroscopy reduction and specific radiation protection strategies.
Subject(s)
Catheter Ablation , Radiation Exposure , Humans , Arrhythmias, Cardiac/therapy , Cardiac Electrophysiology , Electrophysiologic Techniques, Cardiac , Fluoroscopy/methods , Radiation Dosage , Radiation Exposure/adverse effectsABSTRACT
BACKGROUND: Atrial fibrillation is common in patients with structural heart disease who are undergoing cardiac surgery. Surgical CryoMaze has been shown to be an effective treatment in several trials, but success rates have varied considerably, between 47-95%. The sequential hybrid approach, combining surgical CryoMaze followed by radiofrequency catheter ablation, can achieve high freedom from atrial arrhythmias. However, in patients with concomitant surgical atrial fibrillation treatment, data comparing the hybrid approach to CryoMaze alone are lacking. METHODS: The SurHyb study was designed as a prospective, open-label, multicentre randomized trial. Patients with non-paroxysmal atrial fibrillation who were scheduled for coronary artery bypass grafting or valve repair/replacement were randomized to either surgical CryoMaze alone or surgical CryoMaze followed by radiofrequency catheter ablation 3 months post-surgery. The primary outcome measure was arrhythmia-free survival without class I or III antiarrhythmic drugs, which has been evaluated using implantable cardiac monitors. CONCLUSIONS: This is the first randomized study that compares concomitant surgical CryoMaze alone with the staged hybrid surgical CryoMaze followed by catheter ablation, in patients with non-paroxysmal atrial fibrillation using rigorous rhythm monitoring. The results may contribute to the optimization of the treatment in patients undergoing concomitant CryoMaze for atrial fibrillation.
Subject(s)
Atrial Fibrillation , Cardiac Surgical Procedures , Catheter Ablation , Humans , Anti-Arrhythmia Agents/therapeutic use , Atrial Fibrillation/surgery , Atrial Fibrillation/drug therapy , Cardiac Surgical Procedures/methods , Catheter Ablation/methods , Multicenter Studies as Topic , Prospective Studies , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
BACKGROUND: The study is intended to evaluate the acute and long-term effectiveness and peri-procedural safety in ablation of persistent atrial fibrillation (PsAF) using the CartoFinder algorithm guided ablation (CFGA) targeting on repetitive activation patterns (RAPs) and focal impulses (FIs) identified in dynamic maps. METHODS: This is a prospective, single-arm, multicenter study. A 64-pole multielectrode basket catheter was used for intracardiac global electrogram (EGM) mapping. The RAPs or FIs were repeatedly mapped and ablated for up to five iterations by the CartoFinder algorithm to achieve sinus rhythm (SR) or organized atrial tachycardia (AT), which were followed by PVI. All patients were followed up for 12 months after procedure. RESULTS: Sixty-four PsAF patients (age, 60.7 ± 9.1 years; male, 76.6%; median PsAF duration, 6.0 months) underwent CFGA on RAPs/FIs. Six patients (9.4%) reported primary adverse event (PAE) including groin hematoma (2), complete heart block (1), tamponade (1), pericarditis (1), and pseudoaneurysm (1). Repeated mapping and ablation on RAPs/FIs resulted in the cycle length (CL) increase from 191.0 ± 167.6 ms at baseline to 365.7 ± 296.7 ms in the LA and from 167.8 ± 41.6 ms to 379.4 ± 293.5 ms in the RA and 30.2% (19/63) AF termination to SR or organized AT. The 12-month arrhythmia-free and symptomatic AF-free rates were 60.9% and 75.0%, respectively. Patients with acute AF termination showed a higher 12-month arrhythmia-free rate (76.9%) than those without (50.0%, p = .04). CONCLUSIONS: The study demonstrated that the CartoFinder algorithm can be used for global activation mapping during PsAF ablation. Patients with acute AF termination had a lower 12-month AF recurrence rate compared to patients without.
Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Tachycardia, Supraventricular , Humans , Male , Middle Aged , Aged , Prospective Studies , Treatment Outcome , Recurrence , Catheter Ablation/methods , Pulmonary Veins/surgeryABSTRACT
BACKGROUND: Anderson-Fabry disease (AFD) is an X-linked inherited lysosomal disease caused by a defect in the gene encoding lysosomal enzyme α-galactosidase A (GLA). Atrio-ventricular (AV) nodal conduction defects and sinus node dysfunction are common complications of the disease. It is not fully elucidated how frequently AFD is responsible for acquired AV block or sinus node dysfunction and if some AFD patients could manifest primarily with spontaneous bradycardia in general population. The purpose of study was to evaluate the prevalence of AFD in male patients with implanted permanent pacemaker (PM). METHODS: The prospective multicentric screening in consecutive male patients between 35 and 65 years with implanted PM for acquired third- or second- degree type 2 AV block or symptomatic second- degree type 1 AV block or sinus node dysfunction was performed. RESULTS: A total of 484 patients (mean age 54 ± 12 years at time of PM implantation) were enrolled to the screening in 12 local sites in Czech Republic. Out of all patients, negative result was found in 481 (99%) subjects. In 3 cases, a GLA variant was found, classified as benign: p.Asp313Tyr, p.D313Y). Pathogenic GLA variants (classical or non-classical form) or variants of unclear significance were not detected. CONCLUSION: The prevalence of pathogenic variants causing AFD in a general population sample with implanted permanent PM for AV conduction defects or sinus node dysfunction seems to be low. Our findings do not advocate a routine screening for AFD in all adult males with clinically significant bradycardia.
Subject(s)
Atrioventricular Block , Fabry Disease , Pacemaker, Artificial , Adult , Humans , Male , Middle Aged , Aged , Bradycardia/complications , Bradycardia/therapy , Fabry Disease/diagnosis , Fabry Disease/epidemiology , Fabry Disease/genetics , Atrioventricular Block/diagnosis , Atrioventricular Block/epidemiology , Atrioventricular Block/therapy , Sick Sinus Syndrome/diagnosis , Sick Sinus Syndrome/epidemiology , Sick Sinus Syndrome/therapy , Prospective Studies , Pacemaker, Artificial/adverse effectsSubject(s)
Atrial Fibrillation , Stroke , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/therapyABSTRACT
BACKGROUND: Restricted outdoor activity during COVID-19 related lockdown may accelerate heart failure (HF) progression and thereby increase cardiac arrhythmias. We analyzed the impact of March/April 2020 lockdown on physical activity and arrhythmia burden in HF patients treated with cardiac resynchronization therapy (CRT) devices with daily, automatic remote monitoring (RM) function. METHODS: The study cohort included 405 HF patients enrolled in Observation of Clinical Routine Care for Heart Failure Patients Implanted with BIOTRONIK CRT Devices (BIO|STREAM.HF) registry in 16 countries, who had left ventricular ejection fraction (LVEF) ≤40% (mean 28.2 ± 6.6%) and NYHA class II/III/IV (47.9%/49.6%/2.5%) before CRT pacemaker/defibrillator implantation. The analyzed RM data comprised physical activity detected by accelerometer, mean heart rate and nocturnal rate, PP variability, percentage of biventricular pacing, atrial high rate episode (AHRE) burden, ventricular extrasystoles and tachyarrhythmias, defibrillator shocks, and number of implant interrogations (i.e., follow-ups). Intraindividual differences in RM parameters before (4-week period) versus during (4-week period) lockdown were tested for statistical significance and independent predictors were identified. RESULTS: There was a significant relative change in activity (mean -6.5%, p < .001), AHRE burden (+17%, p = .013), and follow-up rate (-75%, p < .001) during lockdown, with no significant changes in other RM parameters. Activity decreased by ≥8 min/day in 46.5% of patients; predictors were higher LVEF, lower NYHA class, no defibrillator indication, and more activity before lockdown. AHRE burden increased by ≥17 min/day in 4.7% of patients; predictors were history of atrial fibrillation, higher LVEF, higher body mass index, and activity decrease during lockdown. CONCLUSION: Unfavorable changes in physical activity, AHRE burden, and follow-up rate were observed during lockdown, but not in ventricular arrhythmia.
Subject(s)
Atrial Fibrillation , COVID-19 , Cardiac Resynchronization Therapy , Defibrillators, Implantable , Heart Failure , Atrial Fibrillation/therapy , Communicable Disease Control , Exercise , Heart Failure/epidemiology , Heart Failure/therapy , Humans , Pandemics , Stroke Volume , Treatment Outcome , Ventricular Function, LeftABSTRACT
BACKGROUND: Remote monitoring (RM) is increasingly employed for all types of cardiac implantable devices (CIED). However, there are only limited data on the acceptance of RM by the elderly. The aim of our study was to ascertain how octogenarians assess RM technologies compared to younger, presumably technically more literate patients, and what concerns or technical problems the system presents to both groups of patients. METHODS: The trial was designed as a descriptive, register-based single-center study. The study population consisted of all consecutive patients ≥ 80 years of age (group A, n = 94) and all consecutive patients aged ≤ 40 years (group B, n = 71), who had undergone implantation of an implantable cardioverter-defibrillator (ICD) between the years of 2009 and 2018 and were using a Home MonitoringTM (HM, Biotronik, Berlin, Germany) system. All patients fulfilling entry criteria were approached with a request to participate in the survey. RESULTS: A total of 85 (90.4%) and 65 (91.5%) valid surveys were obtained for groups A and B, respectively. Ninety-two percent of patients in both groups (P = 0.903) were satisfied with the limited number of planned ambulatory follow-ups (i.e., once a year). All patients in both groups (100%) reported that they were satisfied with the HM system, and 97% and 94% of patients in Groups A and B, respectively, ranked it highly beneficial (P = 0.68). A significant proportion of patients in both groups were completely unaware of any health-related benefits associated with the use of the HM system (42% in Group A vs. 49% in Group B, P = 0.4). Among the most frequently reported personal benefits of HM were a sense of safety and security and savings on travel expenses and time. 5% and 9% of patients in Groups A and B, respectively, reported that usage of HM caused them some degree of psychological stress (P = 0.27). Nearly all patients in both groups reported receiving information on HM from their doctor after ICD implantation. None of Group A reported receiving information from a nurse either before or after ICD implantation, while 14% of Group B patients reported receiving information from a nurse after, but not before ICD implantation. Seven and 51% (P < 0.0001) of patients in Group A and B, respectively, sought additional information about HM post-discharge. CONCLUSIONS: The HM system received good marks and was much appreciated, even in patients over 80 years of age. The level of acceptance and potential psychological stress resulting from RM technology appears to be about the same in older patients as in younger patients. The majority of octogenarians either did not fully understand the clinical benefits of the system or mistakenly thought that the HM system was a substitute for emergency 24-h surveillance. These results highlight the need for better patient education relative to RM technology, with one option being to delegate more of this educational process to specially trained nurses.
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INTRODUCTION: Cryoenergy is the most commonly used method of lesion formation in patients who have undergone surgical ablation of atrial fibrillation. Despite frequent use, the clinical effect of cryoenergy in endocardial and epicardial approaches is unknown. AIM: To compare the effect of various cryoenergy applications on the postoperative incidence of sinus rhythm and completeness of lesions performed. MATERIAL AND METHODS: A total of 55 patients underwent concomitant atrial fibrillation surgical ablation using cryoenergy under various conditions: epicardially during cardiac arrest, epicardially on beating heart, and endocardially. In the postoperative period, patients were invited to attend an electrophysiological examination to assess the completeness of surgical ablation lesions and, if necessary, to complete catheter ablation. RESULTS: Twenty-four patients underwent epicardial ablation on the arrested heart (group 1), 12 patients underwent epicardial ablation on the beating heart (group 2), and 19 patients underwent endocardial ablation (group 3). In the electrophysiological examination, sinus rhythm was present in 71% vs. 83% vs. 89% of patients, respectively. The completeness of pulmonary vein isolation was confirmed in 31% vs. 25% vs. 95% of patients, complete box lesions in 15% vs. 0% vs. 79% of patients, respectively. CONCLUSIONS: Despite the similar clinical effect of surgical ablation in all three approaches, the morphologically most effective use of cryoenergy is endocardial ablation. This approach has a very good result. Our findings further support the endocardial use of cryoenergy during surgical ablation of atrial fibrillation.
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OBJECTIVES: This study sought to evaluate the safety and short-term performance of a novel catheter for very high power-short duration (vHPSD) ablation in the treatment of paroxysmal atrial fibrillation. BACKGROUND: The vHPSD catheter is a novel contact force-sensing catheter optimized for temperature-controlled radiofrequency ablation with microelectrodes and 6 thermocouples for real-time temperature monitoring; the associated vHPSD algorithm modulates power to maintain target temperature during 90 W, 4 s lesions. METHODS: QDOT-FAST (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation) is a prospective, multicenter, single-arm study enrolling patients with symptomatic paroxysmal atrial fibrillation indicated for catheter-based pulmonary vein isolation. Primary endpoints were short-term effectiveness (confirmation of entrance block in all targeted pulmonary veins after adenosine/isoproterenol challenge) and short-term safety (primary adverse events). Participants were screened for silent cerebral lesions by magnetic resonance imaging. Patients were followed for 3 months post-ablation. RESULTS: A total of 52 patients underwent ablation and completed follow-up. Pulmonary vein isolation was achieved in all patients using the study catheter alone, with total procedure and fluoroscopy times of 105.2 ± 24.7 min and 6.6 ± 8.2 min, respectively. Most patients (n = 49; 94.2%) were in sinus rhythm at 3 months. Two primary adverse events were reported: 1 pseudoaneurysm; and 1 asymptomatic thromboembolism. There were no deaths, stroke, atrioesophageal fistula, pulmonary vein stenosis, or unanticipated adverse device effects. Six patients had identified silent cerebral lesions-all classified as asymptomatic without clinical or neurologic deficits. CONCLUSIONS: This first-in-human study of a novel catheter with optimized temperature control demonstrated the clinical feasibility and safety of vHPSD ablation. Procedure and fluoroscopy times were substantially lower than historical standard ablation with point-by-point catheters. (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation [QDOT-FAST]; NCT03459196).