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.
- MeSH
- fibrilace síní * chirurgie terapie MeSH
- katetrizační ablace * škodlivé účinky metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- pooperační komplikace epidemiologie etiologie MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
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.
- Publikační typ
- časopisecké články MeSH
INTRODUCTION: Remote monitoring including transmission of electrocardiogram (ECG) strips has been implemented in implantable cardiac monitors (ICM). We appraise whether the physician can rely on remote monitoring to be informed of all possibly significant arrhythmias. METHODS: We analyzed remote monitoring transmissions of patients in the ongoing BIO|GUARD-MI study, in which Biotronik devices are used. Once per day, the devices automatically transmit messages with up to six ECG snapshots to the Home Monitoring Service Center. If more than one type of arrhythmia is recorded during a day, at least one ECG of each arrhythmia type is transmitted. RESULTS: 212 study patients were registered at the service center. The mean age of the patients was 70 ± 8 years, and 74% were male. Patients were followed for an average of 13 months. The median time from device implantation until the first message receipt in the service center was 2 days. The median patient-individual transmission success was 98.0% (IQR 93.6-99.8) and remained stable in the second and third year. The most frequent arrhythmias were atrial fibrillation, bradycardia and high ventricular rate. 17.3% of the messages with ECG snapshots contained more than one arrhythmia type. DISCUSSION: Our analysis confirms that the physician can rely on Home Monitoring to be informed of all possibly significant arrhythmias during long-term follow-up. We have found hints that the transmission of only one episode per day may lead to the loss of clinically relevant information if patients with ICMs are followed by remote monitoring only.
- MeSH
- bradykardie MeSH
- defibrilátory implantabilní * MeSH
- elektrokardiografie ambulantní MeSH
- elektrokardiografie MeSH
- fibrilace síní * MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
