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JAMA Sep 2023
Topics: Mental Health; Pulmonary Veins; Atrial Fibrillation; Humans
PubMed: 37698577
DOI: 10.1001/jama.2023.6484 -
The Journal of Thoracic and... Jun 2024
Topics: Humans; Atrial Fibrillation; Pulmonary Veins; Catheter Ablation; Treatment Outcome
PubMed: 37030474
DOI: 10.1016/j.jtcvs.2023.03.024 -
Journal of Anatomy Jan 2024The left atrium wall has several origins, including the body, appendage, septum, atrial-ventricular canal, posterior wall, and venous component. Here, we describe the...
The left atrium wall has several origins, including the body, appendage, septum, atrial-ventricular canal, posterior wall, and venous component. Here, we describe the morphogenesis of left atrium based on high-resolution imaging (phase-contrast X-ray computed tomography and magnetic resonance imaging). Twenty-three human embryos and 19 fetuses were selected for this study. Three-dimensional cardiac images were reconstructed, and the pulmonary veins and left atrium, including the left atrial appendage, were evaluated morphologically and quantitatively. The positions of the pericardial reflections were used as landmarks for the border of the pericardial cavity. The common pulmonary vein was observed in three specimens at Carnegie stages 17-18. The pericardium was detected at the four pulmonary veins (left superior, left inferior, right superior, and right inferior pulmonary veins) at one specimen at Carnegie stage 18 and all larger specimens, except the four samples. Our results suggest that the position of the pericardial reflections was determined at two pulmonary veins (right and left pulmonary vein) and four pulmonary veins almost simultaneously when the dorsal mesocardial connection between the embryo and heart regressed. The magnetic resonance images and reconstructed heart cavity images confirmed that the left atrium folds were present at the junction between the body and venous component. Three-dimensional reconstruction showed that the four pulmonary veins entered the dorsal left atrium tangentially from the lateral to the medial direction. More specifically, the right pulmonary veins entered at a greater angle than the left pulmonary veins. The distance between the superior and inferior pulmonary veins was shorter than that between the left and right pulmonary veins. Three-dimensional reconstruction showed that the venous component increased proportionally with growth. No noticeable differences in discrimination between the right and left parts of the venous component emerged, while the junction between the venous component and body gradually became inconspicuous but was still recognizable by the end of the observed early fetal period. The left superior pulmonary vein had the smallest cross-sectional area and most flattened shape, whereas the other three were similar in area and shape. The left atrial appendage had a large volume in the center and extended to the periphery as a lobe-like structure. The left atrial appendage orifice increased in the area and tended to become flatter with growth. The whole left atrium volume^(1/3) increased almost proportionally with growth, parallel to the whole heart volume. This study provided a three-dimensional and quantitative description of the developmental process of the left atrium, comprising the venous component and left atrial appendage formation, from the late embryonic to the early fetal stages.
Topics: Humans; Pulmonary Veins; Atrial Appendage; Heart Atria; Fetus; Morphogenesis
PubMed: 37559438
DOI: 10.1111/joa.13941 -
Journal of Cardiovascular... Nov 2023Pulsed-field ablation (PFA) has emerged as a nonthermal energy source for cardiac ablation, with potential safety advantages over radiofrequency ablation (RFA) and...
BACKGROUND
Pulsed-field ablation (PFA) has emerged as a nonthermal energy source for cardiac ablation, with potential safety advantages over radiofrequency ablation (RFA) and cryoballoon ablation.
OBJECTIVE
To report the preclinical results of a novel hexaspline PFA catheter for pulmonary vein isolation (PVI), and to verify the influence of PFA on esophagus by comparing with RFA.
METHODS
This study included a total of 15 canines for the efficacy and safety study and four swine for the esophageal safety study. The 15 canines were divided into an acute cohort (n = 3), a 30-day follow-up cohort (n = 5) and a 90-day follow-up cohort (n = 7), PVI was performed with the novel hexaspline PFA ablation catheter. In the esophageal safety study, four swine were divided into PFA cohort (n = 2) and RFA cohort (n = 2), esophageal injury swine model was adopted, the esophagus was intubated with an esophageal balloon retractor, under fluoroscopy, the DV8 device was inflated with a mixture of saline and contrast and rotated to displace the esophagus rightward and anteriorly toward the ablation catheter in the inferior vena cava (IVC) and right inferior pulmonary vein (PV). Nine PFA applications were delivered at four locations on IVC and two locations on the right inferior PV in the PFA cohort, six RFA applications were delivered at each location in the RFA group. Histopathological analysis of all PVs, esophagus, IVC, and the adjacent lungs was performed.
RESULTS
Acute PV isolation was achieved in all 15 canines (100%), with energy delivery times of less than 3 min/animal. In the 30 and 90 days group, the overall success rates were 88.9% and 88.5% per PVs, respectively. Two right superior pulmonary veins (RSPVs) in the 30-day group, two RSPVs and one left superior PV in the 90-day group with recovered potentials. At follow-up, gross pathological examination revealed the lesions around the PVs were continuous and transmural. Masson's trichrome staining revealed the myocardial cells in the PVs became fibrotic, but small arteries and nervous tissue were preserved. Results of swine esophageal injury model revealed the esophageal luminal surface was smooth and without evidence for esophageal injury in the PFA group, whereas obvious ulceration was detected on the esophagus tunica mucosa in the RFA group.
CONCLUSION
In the chronic canine study, PFA-based PVI were safe and effective with demonstrable sparing of nerves and venous tissue. Compared with RFA, there was also good evidence for safety of PFA, avoiding PV stenosis and esophageal injury. This preclinical study provided the scientific basis for the first-in-human endocardial PFA studies.
Topics: Humans; Swine; Animals; Dogs; Pulmonary Veins; Atrial Fibrillation; Catheter Ablation; Radiofrequency Ablation; Catheters; Treatment Outcome
PubMed: 37712346
DOI: 10.1111/jce.16067 -
Journal of Interventional Cardiac... Oct 2023A compressible lattice-tip catheter designed for focal ablation using radiofrequency or pulsed-field energies has been recently described. The objective of this study is... (Review)
Review
BACKGROUND
A compressible lattice-tip catheter designed for focal ablation using radiofrequency or pulsed-field energies has been recently described. The objective of this study is to describe a new lattice catheter designed for single-shot pulmonary vein isolation (PVI).
METHODS
This 8F catheter consists of a compressible lattice tip that is delivered over the wire and is expandable up to 34 mm (SpherePVI™, Affera Inc.). Pulsed field ablation (PFA) was applied from 6 elements using a biphasic waveform of microsecond scale (± 1.3-2.0 kV, 5 s per application). In 12 swine, the superior vena cava (SVC) and right superior pulmonary vein (RSPV) were targeted for isolation. Animals were survived for 12-24 h (n = 6) or 3 weeks (n = 6) for evaluation of short and long-term safety and efficacy parameters. PVI was evaluated immediately after ablation and at the terminal procedure. Ablation-related microbubbles were examined using intracardiac echocardiography and phrenic nerve function by pacing. The tissue was examined by histopathology.
RESULTS
In all 12 animals, PFA resulted in successful acute isolation of the SVC and RSPV using 2.8 ± 1.1 and 3.2 ± 1.2 applications per vein, respectively. After a survival period of 23 ± 5.9 days, all targeted veins remained isolated, and the level of isolation persisted without significant regression or expansion. In one animal, SVC isolation at the level of the right atrial appendage resulted in sinus node arrest. PFA did not affect phrenic nerve function, and it was associated with a few isolated bubbles formation.
CONCLUSIONS
In this pre-clinical study, a new expandable lattice catheter designed for single-shot PVI was able to achieve rapid and durable isolation.
Topics: Swine; Animals; Atrial Fibrillation; Pulmonary Veins; Catheter Ablation; Vena Cava, Superior; Catheters; Treatment Outcome
PubMed: 36441424
DOI: 10.1007/s10840-022-01414-7 -
JACC. Clinical Electrophysiology May 2024Pulmonary vein isolation (PVI) alone is insufficient to treat many patients with persistent atrial fibrillation (PersAF). Adjunctive left atrial posterior wall (LAPW)...
BACKGROUND
Pulmonary vein isolation (PVI) alone is insufficient to treat many patients with persistent atrial fibrillation (PersAF). Adjunctive left atrial posterior wall (LAPW) ablation with thermal technologies has revealed lack of efficacy, perhaps limited by the difficulty in achieving lesion durability amid concerns of esophageal injury.
OBJECTIVES
This study aims to compare the safety and effectiveness of PVI + LAPW ablation vs PVI in patients with PersAF using pulsed-field ablation (PFA).
METHODS
In a retrospective analysis of the MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-approval Clinical Use of Pulsed Field Ablation) registry, we studied consecutive PersAF patients undergoing post-approval treatment with a pentaspline PFA catheter. The primary effectiveness outcome was freedom from any atrial arrhythmia of ≥30 seconds. Safety outcomes included the composite of acute and chronic major adverse events.
RESULTS
Of the 547 patients with PersAF who underwent PFA, 131 (24%) received adjunctive LAPW ablation. Compared to PVI-alone, patients receiving adjunctive LAPW ablation were younger (65 vs 67 years of age, P = 0.08), had a lower CHADS-VASc score (2.3 ± 1.6 vs 2.6 ± 1.6, P = 0.08), and were more likely to receive electroanatomical mapping (48.1% vs 39.0%, P = 0.07) and intracardiac echocardiography imaging (46.1% vs 17.1%, P < 0.001). The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmias was not statistically different between groups in the full (PVI + LAPW: 66.4%; 95% CI: 57.6%-74.4% vs PVI: 73.1%; 95% CI: 68.5%-77.2%; P = 0.68) and propensity-matched cohorts (PVI + LAPW: 71.7% vs PVI: 68.5%; P = 0.34). There was also no significant difference in major adverse events between the groups (2.2% vs 1.4%, respectively, P = 0.51).
CONCLUSIONS
In patients with PersAF undergoing PFA, as compared to PVI-alone, adjunctive LAPW ablation did not improve freedom from atrial arrhythmia at 12 months.
Topics: Humans; Atrial Fibrillation; Male; Female; Aged; Catheter Ablation; Middle Aged; Retrospective Studies; Heart Atria; Pulmonary Veins; Treatment Outcome; Registries
PubMed: 38430087
DOI: 10.1016/j.jacep.2024.01.017 -
Circulation. Arrhythmia and... Sep 2023
Topics: Pulmonary Veins; Humans; Ablation Techniques
PubMed: 37638409
DOI: 10.1161/CIRCEP.123.012093 -
JAMA Apr 2024Left atrial appendage elimination may improve catheter ablation outcomes for atrial fibrillation. (Comparative Study)
Comparative Study Randomized Controlled Trial
IMPORTANCE
Left atrial appendage elimination may improve catheter ablation outcomes for atrial fibrillation.
OBJECTIVE
To assess the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to catheter pulmonary vein isolation for nonparoxysmal atrial fibrillation.
DESIGN, SETTING, AND PARTICIPANTS
This multicenter, prospective, open-label, randomized clinical trial evaluated the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to planned pulmonary vein isolation for nonparoxysmal atrial fibrillation present for less than 3 years. Eligible patients were randomized in a 2:1 ratio to undergo left atrial appendage ligation and pulmonary vein isolation or pulmonary vein isolation alone. Use of a 2:1 randomization ratio was intended to provide more device experience and safety data. Patients were enrolled from October 2015 to December 2019 at 53 US sites, with the final follow-up visit on April 21, 2021.
INTERVENTIONS
Left atrial appendage ligation plus pulmonary vein isolation compared with pulmonary vein isolation alone.
MAIN OUTCOMES AND MEASURES
A bayesian adaptive analysis was used for primary end points. Primary effectiveness was freedom from documented atrial arrythmias of greater than 30 seconds duration 12 months after undergoing pulmonary vein isolation. Rhythm was assessed by Holter monitoring at 6 and 12 months after pulmonary vein isolation, symptomatic event monitoring, or any electrocardiographic tracing obtained through 12 months after pulmonary vein isolation. Primary safety was a composite of predefined serious adverse events compared with a prespecified 10% performance goal 30 days after the procedure. Left atrial appendage closure was evaluated through 12 months after pulmonary vein isolation.
RESULTS
Overall, 404 patients were randomized to undergo left atrial appendage ligation plus pulmonary vein isolation and 206 were randomized to undergo pulmonary vein isolation alone. Primary effectiveness was 64.3% with left atrial appendage ligation and pulmonary vein isolation and 59.9% with pulmonary vein isolation only (difference, 4.3% [bayesian 95% credible interval, -4.2% to 13.2%]; posterior superiority probability, 0.835), which did not meet the statistical criterion to establish superiority (0.977). Primary safety was met, with a 30-day serious adverse event rate of 3.4% (bayesian 95% credible interval, 2.0% to 5.0%; posterior probability, 1.0) which was less than the prespecified threshold of 10%. At 12 months after pulmonary vein isolation, complete left atrial appendage closure (0 mm residual communication) was observed in 84% of patients and less than or equal to 5 mm residual communication was observed in 99% of patients.
CONCLUSIONS AND RELEVANCE
Percutaneous left atrial appendage ligation adjunctive to pulmonary vein isolation did not meet prespecified efficacy criteria for freedom from atrial arrhythmias at 12 months compared with pulmonary vein isolation alone for patients with nonparoxysmal atrial fibrillation, but met prespecified safety criteria and demonstrated high rates of closure at 12 months.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02513797.
Topics: Humans; Atrial Appendage; Atrial Fibrillation; Bayes Theorem; Organothiophosphorus Compounds; Prospective Studies; Pulmonary Veins; Catheter Ablation; Catheterization
PubMed: 38563835
DOI: 10.1001/jama.2024.3026 -
BMC Pregnancy and Childbirth Aug 2023In clinical obstetrics, many guidelines recommended the use of Doppler fetal ductus venosus blood flow to monitor and to manage fetal growth restriction (FGR). The...
BACKGROUND
In clinical obstetrics, many guidelines recommended the use of Doppler fetal ductus venosus blood flow to monitor and to manage fetal growth restriction (FGR). The ductus venosus and the pulmonary venous flow pattern of fetuses are similar. Umbilical artery pH (UA pH) is essential in identifying adverse pregnancy outcomes, particularly in fetal growth restriction cases. Nevertheless, the literature indicates that the relationship between pulmonary vein pulsatility index (PVPI) and UA pH in FGR cases has not been well investigated. This study aimed to identify the alteration in PVPI in FGR cases and evaluate the correlation between PVPI and UA pH in FGR newborns.
METHODS
This matched cohort study of singleton pregnancies from 28 to 40 weeks of gestation without congenital abnormalities included 135 cases of FGR (disease group) and 135 cases of normal growth (control group). The PVPI was measured at the proximal segment of the right or left pulmonary vein, approximately 5 mm from the left atrium wall. The umbilical artery pulsatility index (UAPI) was measured on the free umbilical cord. An elective cesarean section or labor induction are both options for ending the pregnancy, depending on the condition of the mother or fetus. Umbilical artery blood samples were collected within 5 min of delivery for UA pH measurement. SPSS version 20 and Medcalc version 20.1 were used for data analysis.
RESULTS
FGR cases had a significantly higher mean fetal PVPI than the control group (1.16 ± 0.26 vs. 0.84 ± 0.16; p < 0.01), and PVPI and UAPI were positively correlated (r = 0.63; p < 0.001). PVPI and UA pH were negatively correlated in FGR patients, with r = -0.68; p < 0.001. The PVPI value on the 95th percentile had a prognostic value of UA pH < 7.20 with a sensitivity of 88.2%, specificity of 66.3%, positive predictive value of 46.9%, and negative predictive value of 94.3%.
CONCLUSIONS
There was a statistically significant difference in PVPI values in FGR cases compared to the normal growth group, a positive correlation between PVPI and UAPI, and a negative correlation between PVPI and UA pH. PVPI might have a prognostic meaning in predicting UA pH at birth.
Topics: Infant, Newborn; Pregnancy; Humans; Female; Pulmonary Veins; Umbilical Arteries; Cesarean Section; Cohort Studies; Fetal Growth Retardation; Southeast Asian People
PubMed: 37648979
DOI: 10.1186/s12884-023-05910-0 -
Current Opinion in Cardiology Jan 2024This review highlights pulse field ablation's (PFA) significance in treating atrial fibrillation. PFA uses short-pulsed electrical fields, offering safety advantages... (Review)
Review
PURPOSE OF REVIEW
This review highlights pulse field ablation's (PFA) significance in treating atrial fibrillation. PFA uses short-pulsed electrical fields, offering safety advantages over thermal methods. Multicenter studies' findings on PFA's safety, efficiency, and efficacy, compared with thermal techniques, are discussed.
RECENT FINDINGS
The review encompasses major PFA systems utilized in multicenter studies: penta-spline, circular, and lattice catheters. These studies affirm PFA's safety, with minimal complications like esophageal injury, phrenic nerve complications, and pulmonary vein stenosis. PFA also demonstrates procedural efficiency benefits because of rapid pulse delivery. However, PFA's efficacy appears on par with thermal ablation, showing similar rates of atrial arrhythmia recurrence during follow-up periods. The studies explore diverse postablation monitoring strategies, underscoring the necessity for standardized monitoring or consistent transformation of arrhythmia data.
SUMMARY
In conclusion, PFA marks a promising era for atrial fibrillation treatment with improved safety and efficiency. Efficacy is comparable to thermal methods, though technology advancements could alter this. PFA's potential as a safer and faster alternative positions it as a dominant atrial fibrillation ablation technology. Careful analysis and standardized monitoring are vital to assess PFA's potential and clinical implications.
Topics: Humans; Atrial Fibrillation; Irreversible Electroporation Therapy; Heart Rate; Catheter Ablation; Pentaerythritol Tetranitrate; Treatment Outcome; Pulmonary Veins
PubMed: 37712587
DOI: 10.1097/HCO.0000000000001094