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Advances in Therapy Mar 2024Cryoballoon ablation (CBA) is a standard catheter ablation technology with demonstrated clinical effectiveness for the treatment of paroxysmal atrial fibrillation (PAF);... (Review)
Review
Comparative Safety of Pulsed Field Ablation and Cryoballoon Ablation Technologies for Pulmonary Vein Isolation in Patients with Paroxysmal Atrial Fibrillation: A Critical Literature Review and Indirect Treatment Comparison.
INTRODUCTION
Cryoballoon ablation (CBA) is a standard catheter ablation technology with demonstrated clinical effectiveness for the treatment of paroxysmal atrial fibrillation (PAF); however, it can be associated with major adverse events, including phrenic nerve paralysis. Pulsed field ablation (PFA) is a novel, minimally thermal technology with comparable effectiveness and low safety risk. This study aimed to compare the safety profiles of PFA and CBA through critical analyses of the literature and indirect treatment comparisons.
METHODS
Studies were identified by searching the MEDLINE database and the Clinicaltrials.gov registry. Registered clinical trials and/or Food and Drug Administration Investigation Device Exemption (FDA IDE) studies evaluating PFA or CBA in adult patients with drug-refractory PAF between January 2008 and March 2023 were selected. Comparative safety between PFA and CBA was assessed for major and prespecified adverse events. Indirect comparisons were conducted using the proportion of patients experiencing adverse events and confirmed with single-arm meta-analyses and sensitivity analyses.
RESULTS
Data were extracted from three PFA publications including a total of 497 patients and six CBA studies including a total of 1113 patients. The analysis revealed that PFA was associated with significantly lower risk of major adverse events {risk difference - 4.3% [95% confidence interval (CI) - 5.8, - 2.8]; risk ratio 0.16 [95% CI 0.07, 0.45]} and prespecified adverse events [risk difference - 2.5% (95% CI - 4.4, - 0.5); risk ratio 0.53 (95% CI 0.31, 0.96)]. Meta-analyses confirmed the lower rate of major adverse events for PFA [0.4% (95% CI 0.0, 1.3)] vs. CBA [5.6% (95% CI 2.6, 8.6)] and prespecified adverse events for PFA [2.7% (95% CI 1.2, 4.1)] vs. CBA [5.8% (95% CI 2.7, 9.0)]. Sensitivity analyses exploring heterogeneity across studies confirmed robustness of the main analyses.
CONCLUSION
The findings of this study show that PFA has a more favorable safety profile than CBA, with significantly lower risks of major and prespecified adverse events. These indirect comparisons help contextualize the safety of PFA compared to CBA for the treatment of drug-refractory PAF in the absence of head-to-head studies.
Topics: Adult; Humans; Atrial Fibrillation; Cryosurgery; Pulmonary Veins; Treatment Outcome; Catheter Ablation; Recurrence
PubMed: 38185778
DOI: 10.1007/s12325-023-02765-x -
Frontiers in Physiology 2023The pre-Bötzinger complex, situated in the ventrolateral medulla, serves as the central generator for the inspiratory phase of the respiratory rhythm. Evidence strongly...
The pre-Bötzinger complex, situated in the ventrolateral medulla, serves as the central generator for the inspiratory phase of the respiratory rhythm. Evidence strongly supports its pivotal role in generating, and, in conjunction with the post-inspiratory complex and the lateral parafacial nucleus, in shaping the respiratory rhythm. While there remains an ongoing debate concerning the mechanisms underlying these nuclei's ability to generate and modulate breathing, transgenic rodent models have significantly contributed to our understanding of these processes. However, there is a significant knowledge gap regarding the spectrum of transgenic rodent lines developed for studying respiratory rhythm, and the methodologies employed in these models. In this study, we conducted a scoping review to identify commonly used transgenic rodent lines and techniques for studying respiratory rhythm generation and modulation. Following PRISMA guidelines, we identified relevant papers in PubMed and EBSCO on 29 March 2023, and transgenic lines in Mouse Genome Informatics and the International Mouse Phenotyping Consortium. With strict inclusion and exclusion criteria, we identified 80 publications spanning 1997-2022 using 107 rodent lines. Our findings revealed 30 lines focusing on rhythm generation, 61 on modulation, and 16 on both. The primary method was whole-body plethysmography. The main method was hypoglossal/phrenic nerve recordings using the preparation. Additionally, we identified 119 transgenic lines with the potential for investigating the intricate mechanisms underlying respiratory rhythm. Through this review, we provide insights needed to design more effective experiments with transgenic animals to unravel the mechanisms governing respiratory rhythm. The identified transgenic rodent lines and methodological approaches compile current knowledge and guide future research towards filling knowledge gaps in respiratory rhythm generation and modulation.
PubMed: 38179140
DOI: 10.3389/fphys.2023.1295632 -
Arrhythmia & Electrophysiology Review 2023Cardiac resynchronisation therapy (CRT) reduces the risk of heart failure-related hospitalisations and all-cause mortality, as well as improving quality of life and... (Review)
Review
Cardiac resynchronisation therapy (CRT) reduces the risk of heart failure-related hospitalisations and all-cause mortality, as well as improving quality of life and functional status in patients with persistent heart failure symptoms despite optimal medical treatment and left bundle branch block. CRT has traditionally been delivered by implanting a lead through the coronary sinus to capture the left ventricular epicardium; however, this approach is associated with significant drawbacks, including a high rate of procedural failure, phrenic nerve stimulation, high pacing thresholds and lead dislodgement. Moreover, a significant proportion of patients fail to derive any significant benefit. Left bundle branch area pacing (LBBAP) has recently emerged as a suitable alternative to traditional CRT. By stimulating the cardiac conduction system physiologically, LBBAP can result in a more homogeneous left ventricular contraction and relaxation, thus having the potential to improve outcomes compared with conventional CRT strategies. In this article, the evidence supporting the use of LBBAP in patients with heart failure is reviewed.
PubMed: 38173800
DOI: 10.15420/aer.2023.15 -
Frontiers in Cardiovascular Medicine 2023Cryoballoon ablation (CBA) and laser balloon ablation (LBA) are two innovative ways for the treatment of atrial fibrillation (AF). This study aimed to evaluate the... (Review)
Review
BACKGROUND
Cryoballoon ablation (CBA) and laser balloon ablation (LBA) are two innovative ways for the treatment of atrial fibrillation (AF). This study aimed to evaluate the efficacy and safety of cryoballoon ablation and laser balloon ablation in patients with AF.
METHODS
We searched Pubmed, Embase, Ovid, Web of Science and other databases for comparative trials comparing CB and LB ablation in the treatment of AF, from establishment of database to August, 2023.
RESULTS
A total of 13 studies and 3,582 patients were included (CBA, = 2,308; LBA, = 1,274). There was no difference between CBA and LBA in acute PVI rate per vein, 12-months recurrence rate of AF, 12-months recurrence rate of atrial arrhythmia, occurrence rate of pericardial tamponade, occurrence rate of inguinal complications. LBA presented a lower acute PVI rate per patients (CBA 97.0% vs. LBA 93.4%, RR = 1.04, 95%CI: 1.01-1.07). Transient nerve palsy was more likely to occur after CBA (CBA 2.7% vs. LBA 0.7%, RR = 4.25, 95%CI: 2.06-8.76). However, the occurrence of persistent nerve palsy between CBA and LBA groups were similar (CB 1.4% vs. LB 1.0%, RR = 1.09, 95%CI: 0.55-2.14). In terms of procedural duration, the procedural time of CBA was shorter than that of LBA (WMD = -26.58, 95%CI: -36.71-16.46).
CONCLUSIONS
Compared with LBA, CBA had a shorter procedural duration. There was a higher incidence of transient but not persistent phrenic nerve palsy after CBA.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=272607 Identifier (CRD42021272607).
PubMed: 38169911
DOI: 10.3389/fcvm.2023.1278635 -
Cureus Nov 2023Reverse total shoulder arthroplasty (RTSA) is a widely employed surgical intervention for managing advanced shoulder arthritis. Postoperatively, patients frequently...
Reverse total shoulder arthroplasty (RTSA) is a widely employed surgical intervention for managing advanced shoulder arthritis. Postoperatively, patients frequently experience intense pain, particularly within the first 48 hours. Effective pain management through regional analgesia not only facilitates a quicker hospital discharge but also minimizes the reliance on opioids. One such regional analgesic approach is the combined suprascapular and axillary nerve block, which targets the glenohumeral joint, rotator cuff muscles, and the shoulder's lateral region for effective pain alleviation. Previous research indicates that this dual nerve block method offers sustained pain relief while circumventing the respiratory complications commonly associated with interscalene brachial plexus blocks, which may inadvertently block the phrenic nerve and affect respiration. We report the case of a 75-year-old female, diagnosed with severe chronic obstructive pulmonary disease (COPD) and bronchiectasis on multiple inhalers, who presented for RTSA. The patient had a strong desire to avoid opioids for pain control due to adverse side effects. Through a suprascapular nerve catheter and axillary nerve single shot, regional analgesia was administered, which minimized the risk of respiratory complications due to potential phrenic nerve involvement from an interscalene approach. There were no opioids taken in the postoperative period after discharge, and the patient only received oral acetaminophen. The patient experienced a successful recovery without any respiratory complications and was extremely satisfied with her management.
PubMed: 38161914
DOI: 10.7759/cureus.49670 -
Journal of Cardiovascular Development... Dec 2023Electroporation is used in medicine for drug and gene delivery, and as a nonthermal ablation method in tumor treatment and cardiac ablation. Electroporation involves...
Electroporation is used in medicine for drug and gene delivery, and as a nonthermal ablation method in tumor treatment and cardiac ablation. Electroporation involves delivering high-voltage electric pulses to target tissue; however, this can cause effects beyond the intended target tissue like nerve stimulation, muscle contractions and pain, requiring use of sedatives or anesthetics. It was previously shown that adjusting pulse parameters may mitigate some of these effects, but not how these adjustments would affect electroporation's efficacy. We investigated the effect of varying pulse parameters such as interphase and interpulse delay while keeping the duration and number of pulses constant on nerve stimulation, muscle contraction and assessing pain and electroporation efficacy, conducting experiments on human volunteers, tissue samples and cell lines in vitro. Our results show that using specific pulse parameters, particularly short high-frequency biphasic pulses with short interphase and long interpulse delays, reduces muscle contractions and pain sensations in healthy individuals. Higher stimulation thresholds were also observed in experiments on isolated swine phrenic nerves and human esophagus tissues. However, changes in the interphase and interpulse delays did not affect the cell permeability and survival, suggesting that modifying the pulse parameters could minimize adverse effects while preserving therapeutic goals in electroporation.
PubMed: 38132658
DOI: 10.3390/jcdd10120490 -
Intensive Care Medicine Experimental Dec 2023Side effects of mechanical ventilation, such as ventilator-induced diaphragmatic dysfunction (VIDD) and ventilator-induced lung injury (VILI), occur frequently in... (Review)
Review
Side effects of mechanical ventilation, such as ventilator-induced diaphragmatic dysfunction (VIDD) and ventilator-induced lung injury (VILI), occur frequently in critically ill patients. Phrenic nerve stimulation (PNS) has been a valuable tool for diagnosing VIDD by assessing respiratory muscle strength in response to magnetic PNS. The detection of pathophysiologically reduced respiratory muscle strength is correlated with weaning failure, longer mechanical ventilation time, and mortality. Non-invasive electromagnetic PNS designed for diagnostic use is a reference technique that allows clinicians to measure transdiaphragm pressure as a surrogate parameter for diaphragm strength and functionality. This helps to identify diaphragm-related issues that may impact weaning readiness and respiratory support requirements, although lack of lung volume measurement poses a challenge to interpretation. In recent years, therapeutic PNS has been demonstrated as feasible and safe in lung-healthy and critically ill patients. Effects on critically ill patients' VIDD or diaphragm atrophy outcomes are the subject of ongoing research. The currently investigated application forms are diverse and vary from invasive to non-invasive and from electrical to (electro)magnetic PNS, with most data available for electrical stimulation. Increased inspiratory muscle strength and improved diaphragm activity (e.g., excursion, thickening fraction, and thickness) indicate the potential of the technique for beneficial effects on clinical outcomes as it has been successfully used in spinal cord injured patients. Concerning the potential for electrophrenic respiration, the data obtained with non-invasive electromagnetic PNS suggest that the induced diaphragmatic contractions result in airway pressure swings and tidal volumes remaining within the thresholds of lung-protective mechanical ventilation. PNS holds significant promise as a therapeutic intervention in the critical care setting, with potential applications for ameliorating VIDD and the ability for diaphragm training in a safe lung-protective spectrum, thereby possibly reducing the risk of VILI indirectly. Outcomes of such diaphragm training have not been sufficiently explored to date but offer the perspective for enhanced patient care and reducing weaning failure. Future research might focus on using PNS in combination with invasive and non-invasive assisted ventilation with automatic synchronisation and the modulation of PNS with spontaneous breathing efforts. Explorative approaches may investigate the feasibility of long-term electrophrenic ventilation as an alternative to positive pressure-based ventilation.
PubMed: 38109016
DOI: 10.1186/s40635-023-00577-5 -
JACC. Asia Oct 2023Cryoballoon ablation (CBA) has emerged as an effective treatment for atrial fibrillation (AF).
BACKGROUND
Cryoballoon ablation (CBA) has emerged as an effective treatment for atrial fibrillation (AF).
OBJECTIVES
This study sought to assess the performance of a novel liquid nitrogen-driven CBA system and evaluate its safety and efficacy in the treatment of drug-resistant paroxysmal atrial fibrillation (PAF).
METHODS
This was a prospective multicenter single-arm clinical trial with 10 participating tertiary hospitals enrolling 176 patients with PAF. All participants received liquid nitrogen-driven CBA developed by the Cryofocus Medtech Company. Scheduled follow-up was performed before discharge and 3 months, 6 months, and 12 months after CBA. The primary endpoints were defined as 1) treatment success (freedom from antiarrhythmic drugs and atrial tachycardia at 12 months after CBA); and 2) immediate success rate of pulmonary vein isolation. The safety endpoint was the incidence of device- and procedure-related adverse events (AEs) and all-cause mortality.
RESULTS
A total of 172 participants were included, with an average age of 59.22 ± 9.25 years and 99 (57.56%) of them men. Immediate success rate was 97.67% (95% CI: 94.15%-99.36%) and 12-month treatment success rate was 82.56% (95% CI: 76.89%-88.23%), including a late recurrence rate of 13.61%. Incidences of device- and procedure-related AEs were 2.27% and 25.00%, respectively. Phrenic nerve palsy (PNP) occurred in 6 patients, of which 5 recovered during follow-up. Although the incidence of total severe AEs was 17.05%, including an all-cause mortality of 0.57%, only 1 case of permanent PNP was related to the CBA procedure.
CONCLUSIONS
This premarketing prospective multicenter single-arm clinical trial demonstrated that the liquid nitrogen cryoablation system is safe and effective in the treatment of PAF.
PubMed: 38095010
DOI: 10.1016/j.jacasi.2023.07.005 -
Anesthesiology Mar 2024Lung protective ventilation aims at limiting lung stress and strain. By reducing the amount of pressure transmitted by the ventilator into the lungs, diaphragm...
BACKGROUND
Lung protective ventilation aims at limiting lung stress and strain. By reducing the amount of pressure transmitted by the ventilator into the lungs, diaphragm neurostimulation offers a promising approach to minimize ventilator-induced lung injury. This study investigates the physiologic effects of diaphragm neurostimulation in acute respiratory distress syndrome (ARDS) patients. The hypothesis was that diaphragm neurostimulation would improve oxygenation, would limit the distending pressures of the lungs, and would improve cardiac output.
METHODS
Patients with moderate ARDS were included after 48 h of invasive mechanical ventilation and had a left subclavian catheter placed to deliver bilateral transvenous phrenic nerve stimulation. Two 60-min volume-controlled mechanical ventilation (control) sessions were interspersed by two 60-min diaphragm neurostimulation sessions delivered continually, in synchrony with the ventilator. Gas exchange, lung mechanics, chest electrical impedance tomography, and cardiac index were continuously monitored and compared across four sessions. The primary endpoint was the Pao2/fraction of inspired oxygen (Fio2) ratio at the end of each session, and the secondary endpoints were lung mechanics and hemodynamics.
RESULTS
Thirteen patients were enrolled but the catheter could not be inserted in one, leaving 12 patients for analysis. All sessions were conducted without interruption and well tolerated. The Pao2/Fio2 ratio did not change during the four sessions. Median (interquartile range) plateau pressure was 23 (20 to 31) cm H2O and 21 (17 to 25) cm H2O, driving pressure was 14 (12 to 18) cm H2O and 11 (10 to 13) cm H2O, and end-inspiratory transpulmonary pressure was 9 (5 to 11) cm H2O and 7 (4 to 11) cm H2O during mechanical ventilation alone and during mechanical ventilation + neurostimulation session, respectively. The dorsal/ventral ventilation surface ratio was 0.70 (0.54 to 0.91) when on mechanical ventilation and 1.20 (0.76 to 1.33) during the mechanical ventilation + neurostimulation session. The cardiac index was 2.7 (2.3 to 3.5) l · min-1 · m-2 on mechanical ventilation and 3.0 (2.4 to 3.9) l · min-1 · m-2 on mechanical ventilation + neurostimulation.
CONCLUSIONS
This proof-of-concept study showed the feasibility of short-term diaphragm neurostimulation in conjunction with mechanical ventilation in ARDS patients. Diaphragm neurostimulation was associated with positive effects on lung mechanics and on hemodynamics.
Topics: Humans; Positive-Pressure Respiration; Diaphragm; Respiratory Mechanics; Respiration, Artificial; Respiratory Distress Syndrome
PubMed: 38088791
DOI: 10.1097/ALN.0000000000004873 -
Open Heart Dec 2023Cryoballoon ablation, especially Arctic Front Advance Pro (AFA-Pro) (Medtronic, Minneapolis, Minnesota, USA), has been widely recognised as a standard approach to atrial...
BACKGROUND
Cryoballoon ablation, especially Arctic Front Advance Pro (AFA-Pro) (Medtronic, Minneapolis, Minnesota, USA), has been widely recognised as a standard approach to atrial fibrillation (AF). Recently, Boston Scientific has released a novel cryoballoon system (POLARx). Despite comparable acute clinical outcomes of these two cryoballoons, the recent study reported a higher complication rate, especially for phrenic nerve palsy, with POLARx. However, their impact on biological tissue remains unclear.
OBJECTIVE
The purpose of our study is to evaluate temperature change of biological tissue during cryoablation of each cryoballoon using a porcine experimental model.
METHOD
A tissue-based pulmonary vein model was constructed from porcine myocardial tissue and placed on a stage designed to simulate pulmonary vein anatomy and venous flow. Controlled cryoablations of AFA-Pro and POLARx were performed in this model to evaluate the tissue temperature. A temperature sensor was set behind the muscle and cryoballoon ablation was performed after confirming the occlusion of pulmonary vein with cryoballoon.
RESULTS
The mean tissue nadir temperature during cryoablation with AFA-Pro was -41.5°C±4.9°C, while the mean tissue nadir temperature during cryoablation with POLARx was -58.4°C±5.9°C (p<0.001). The mean balloon nadir temperature during cryoablation with AFA-Pro was -54.6°C±2.6°C and the mean balloon nadir temperature during cryoablation with POLARx was -64.7°C±3.8°C (p<0.001).
CONCLUSION
POLARx could freeze the biological tissue more strongly than AFA-Pro.
Topics: Humans; Animals; Swine; Temperature; Catheter Ablation; Equipment Design; Atrial Fibrillation; Cryosurgery
PubMed: 38065585
DOI: 10.1136/openhrt-2023-002426