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Clinical Research in Cardiology :... Mar 2024The cryoballoon (CB) has become a standard tool for pulmonary vein isolation (PVI), but the technology is limited in certain ways. A novel RF-balloon (Heliostar™,...
Balloon technologies for pulmonary vein isolation-12-month outcome and comparison of the novel radiofrequency balloon with the cryoballoon in patients with paroxysmal atrial fibrillation.
BACKGROUND
The cryoballoon (CB) has become a standard tool for pulmonary vein isolation (PVI), but the technology is limited in certain ways. A novel RF-balloon (Heliostar™, Biosense Webster, CA, USA) promises the advantages of a balloon technology in combination with 3D mapping.
METHODS
To assess procedural data and outcome, all patients undergoing RF-balloon PVI were included and compared with data from consecutive patients undergoing CB PVI for paroxysmal AF.
RESULTS
A total of 254 patients (63 ± 13 years, 54% male) were included: 30 patients undergoing RF-balloon and 224 patients CB PVI. Baseline parameters were comparable. Procedure duration (104.3 ± 35.3 min vs. 69.9 ± 23.1 min; p ≤ 0.001) and fluoroscopy time (16.3 ± 7.1 min vs. 11.6 ± 4.9 min; p ≤ 0.001) were longer using the RF-balloon; ablation time (43.5 ± 17.9 vs. 36.4 ± 15.6; p = 0.08) did not differ, and time-to-isolation (TTI) was shorter (18.2 ± 7.0 s vs. 62.8 ± 35.1 s; p ≤ 0.001). Second-generation RF-balloon cases showed shorter ablation time and TTI at comparable procedure duration and fluoroscopy time. One pericardial effusion occurred with the RF-balloon due to complicated transseptal access. During CB PVI in 4/224 patients (1.8%), a phrenic nerve palsy was observed. After 12 months, 78% of patients after RF-balloon and 81% of patients after CB PVI (p = 0.5) were free from atrial arrhythmias.
CONCLUSION
The RF-balloon was safe and effective. Compared with the CB, TTI was shorter, but procedure durations and fluoroscopy times were longer. This can be attributed to a learning curve and the initial necessity for separate 3D map preparation. Considering the results with the second-generation RF-balloon, more experience is needed to determine the potential benefits.
PubMed: 38478088
DOI: 10.1007/s00392-024-02401-w -
Journal of the American Heart... Mar 2024Cryoballoon ablation is currently the gold standard technique for single-shot pulmonary vein isolation (PVI). Pulsed field ablation (PFA) has recently emerged as an...
BACKGROUND
Cryoballoon ablation is currently the gold standard technique for single-shot pulmonary vein isolation (PVI). Pulsed field ablation (PFA) has recently emerged as an interesting nonthermal alternative energy for PVI. The purpose of our study was to evaluate the safety and long-term efficacy of PVI using the pentaspline PFA catheter in comparison to cryoballoon ablation.
METHODS AND RESULTS
Between January 2021 and December 2022, we included all consecutive patients of our center in whom a first PVI-only procedure was performed using PFA or cryoballoon. The choice of the energy was based on patients' preference between general anesthesia (PFA) and local anesthesia (cryoballoon). The primary end point was freedom from documented atrial arrhythmia recurrence after a 3-month blanking period. A total of 301 patients (paroxysmal atrial fibrillation in 220 patients) underwent a first PVI procedure performed using PFA (n=151) or cryoballoon (n=150). Complete short-term PVI was obtained in 144 of 150 patients (96%) in the cryoballoon group and in all patients of the PFA group (=0.01). Procedure duration was significantly longer in the cryoballoon group. Transient and persistent phrenic nerve injuries were observed in the cryoballoon group only (13/150 and 2/150, respectively). One-year freedom from atrial arrhythmia was significantly higher in the PFA group compared with the cryoballoon group (87.9% versus 77.7%; adjusted hazard ratio, 0.53 [95% CI, 0.30-0.96]; =0.037).
CONCLUSIONS
This prospective, comparative, real-life study suggested that PFA could overcome safety limitations of cryoballoon with optimal effectiveness. Randomized controlled studies are required to further investigate the potential superiority of PFA over cryoballoon.
Topics: Humans; Atrial Fibrillation; Prospective Studies; Treatment Outcome; Cryosurgery; Catheters; Pulmonary Veins; Catheter Ablation; Recurrence
PubMed: 38471838
DOI: 10.1161/JAHA.123.033146 -
Heart Rhythm Mar 2024
PubMed: 38461921
DOI: 10.1016/j.hrthm.2024.03.009 -
Journal of Cardiovascular... Apr 2024Cryoablation therapy for pulmonary vein isolation (PVI) to treat paroxysmal atrial fibrillation (PAF) is well established. A novel 28 mm cryoballoon system designed to... (Clinical Trial)
Clinical Trial
INTRODUCTION
Cryoablation therapy for pulmonary vein isolation (PVI) to treat paroxysmal atrial fibrillation (PAF) is well established. A novel 28 mm cryoballoon system designed to operate under low pressure to safely reach a lower nadir temperature and maintain constant balloon size during cooling has not been prospectively studied in a large patient population for safety and efficacy. The FROZEN AF (NCT04133168) trial was an international multicenter, open-label, prospective, single-arm study on the safety and performance of a novel cryoballoon system for treatment of PAF.
METHODS AND RESULTS
The study enrolled patients at 44 sites in 10 countries across North America, Europe, and Asia. Subjects were indicated for PVI treatment of PAF and had failed or were intolerant of one or more antiarrhythmic drugs. Procedural outcomes were defined based on the 2017 HRS consensus statement. Follow-up was performed at 7 days, 3, 6, and 12 months. Data are reported as mean ± SD or median (IQR). PVI was performed with a 28 mm cryoballoon in 325 drug refractory PAF patients. Complete PVI was achieved in 95.7% of patients. In cryoablation lesions longer than 60 s, 60.1% of PV isolations required only a single cryoballoon application. Procedure related complications included: phrenic nerve palsy [temporary 4 (1.2%), persistent 0 (0.0%)], cardiac tamponade/perforation 2 (0.6%), and air embolism 1 (0.3%). Freedom from documented atrial arrhythmia recurrence at 12 months was 79.9% (AF 82.7%, AFL 96.5%, AT 98.1%), antiarrhythmic drugs (AAD) were continued or re-initiated in 26.8% of patients after the 3-month blanking period. Additionally, an extension arm enrolled 50 pts for treatment with 28/31 mm variable size cryoballoon. A single temporary PNP occurred in this group, which resolved before discharge. Freedom from documented recurrence at 12 months in these pts was 82.0%.
CONCLUSIONS
This novel cryoballoon may facilitate PVI to treat PAF, providing more options to address the variety of anatomies present in patients with PAF. This cryoballoon system proved to be safe and effective for treatment of patients with drug refractory or drug intolerant PAF.
Topics: Humans; Anti-Arrhythmia Agents; Atrial Fibrillation; Catheter Ablation; Cryosurgery; Heart Injuries; Prospective Studies; Pulmonary Veins; Recurrence; Treatment Outcome
PubMed: 38448797
DOI: 10.1111/jce.16220 -
Journal of Clinical Neuromuscular... Mar 2024Neuromuscular disorders could have respiratory involvement early or late into illness. Rarely, patients may present with a hypercapnic respiratory failure (with minimal... (Review)
Review
OBJECTIVES
Neuromuscular disorders could have respiratory involvement early or late into illness. Rarely, patients may present with a hypercapnic respiratory failure (with minimal motor signs) unmasking an underlying disease. There are hardly any studies which have addressed the spectrum and challenges involved in management of this subset, especially in the real-world scenario.
METHODS
A retrospective study comprising consecutive patients hospitalized with hypercapnic respiratory failure as the sole/dominant manifestation. The clinical-electrophysiological spectrum, phrenic conductions, diaphragm thickness, and outcomes were analyzed.
RESULTS
Twenty-seven patients were included, the mean age was 47.29 (SD 15.22) years, and the median duration of respiratory symptoms was 2 months (interquartile range [IQR] 1-4). Orthopnea was present in 23 patients (85.2%) and encephalopathy in 8 patients (29.6%). Phrenic nerve latencies and amplitudes were abnormal in 83.3% and 95.6%, respectively. Abnormal diaphragm thickness was noted in 78.5%. Based on a comprehensive electrophysiological strategy and paraclinical tests, an etiology was established in all. Reversible etiologies were identified in 17 patients (62.9%). These included myasthenia gravis (anti-AChR and MuSK), inflammatory myopathy, riboflavin transporter deficiency neuronopathy, Pompe disease, bilateral phrenic neuritis, and thyrotoxicosis. Respiratory onset motor neuron disease was diagnosed in 8 patients (29.6%). Despite diaphragmatic involvement, a functional respiratory recovery was noted at discharge (45%) and last follow-up (60%). Predictors for good outcomes included female sex, normal nerve conductions, and recent-onset respiratory symptoms.
DISCUSSION
A good functional recovery was noted in most of the patients including respiratory onset motor neuron disease. A systematic algorithmic approach helps in proper triaging, early diagnosis, and treatment. Clinical and electrodiagnostic challenges and observations from a tertiary care referral center are discussed.
Topics: Humans; Female; Middle Aged; Tertiary Care Centers; Retrospective Studies; Neuromuscular Diseases; Respiratory Insufficiency; Bulbar Palsy, Progressive
PubMed: 38441928
DOI: 10.1097/CND.0000000000000465 -
Clinical Spine Surgery Jul 2024Case report and narrative review. (Review)
Review
STUDY DESIGN
Case report and narrative review.
OBJECTIVE
To explore the therapeutic role of surgical and nonsurgical treatment of diaphragmatic paralysis secondary to spinal cord and nerve root compression.
SUMMARY OF BACKGROUND DATA
Phrenic nerve dysfunction due to central or neuroforaminal stenosis is a rare yet unappreciated etiology of diaphragmatic paralysis and chronic dyspnea. Surgical spine decompression, diaphragmatic pacing, and intensive physiotherapy are potential treatment options with varying degrees of evidence.
METHODS
The case of a 70-year-old male with progressive dyspnea, reduced hemi-diaphragmatic excursion, and C3-C7 stenosis, who underwent a microscopic foraminotomy is discussed. Literature review (MEDLINE, PubMed, Google Scholar) identified 19 similar reports and discussed alternative treatments and outcomes.
RESULTS AND CONCLUSIONS
Phrenic nerve root decompression and improvement in neuromonitoring signals were observed intraoperatively. The patient's postoperative course was uncomplicated, and after 15 months, he experienced significant symptomatic improvement and minor improvement in hemi-diaphragmatic paralysis and pulmonary function tests. All case reports of patients treated with spinal decompression showed symptomatic and/or functional improvement, while one of the 2 patients treated with physiotherapy showed improvement. More studies are needed to further describe the course and outcomes of these interventions, but early identification and spinal decompression can be an effective treatment.
OCEBM LEVEL OF EVIDENCE
Level-4.
Topics: Humans; Male; Aged; Respiratory Paralysis; Cervical Vertebrae; Spinal Stenosis; Treatment Outcome; Decompression, Surgical
PubMed: 38419161
DOI: 10.1097/BSD.0000000000001588 -
Communications Biology Feb 2024The fatal motor neuron (MN) disease Amyotrophic Lateral Sclerosis (ALS) is characterized by progressive MN degeneration. Phrenic MNs (phMNs) controlling the activity of...
The fatal motor neuron (MN) disease Amyotrophic Lateral Sclerosis (ALS) is characterized by progressive MN degeneration. Phrenic MNs (phMNs) controlling the activity of the diaphragm are prone to degeneration in ALS, leading to death by respiratory failure. Understanding of the mechanisms of phMN degeneration in ALS is limited, mainly because human experimental models to study phMNs are lacking. Here we describe a method enabling the derivation of phrenic-like MNs from human iPSCs (hiPSC-phMNs) within 30 days. This protocol uses an optimized combination of small molecules followed by cell-sorting based on a cell-surface protein enriched in hiPSC-phMNs, and is highly reproducible using several hiPSC lines. We show further that hiPSC-phMNs harbouring ALS-associated amplification of the C9orf72 gene progressively lose their electrophysiological activity and undergo increased death compared to isogenic controls. These studies establish a previously unavailable protocol to generate human phMNs offering a disease-relevant system to study mechanisms of respiratory MN dysfunction.
Topics: Humans; Amyotrophic Lateral Sclerosis; Induced Pluripotent Stem Cells; Motor Neurons; Diaphragm; Respiration Disorders; Nerve Degeneration
PubMed: 38418587
DOI: 10.1038/s42003-024-05925-z -
Cureus Jan 2024Background Hiccups are a common physiologic reflex resulting from intermittent and involuntary spasmodic contraction of the diaphragm and intercostal muscles. While most...
Background Hiccups are a common physiologic reflex resulting from intermittent and involuntary spasmodic contraction of the diaphragm and intercostal muscles. While most cases are self-limited, lasting less than 48 hours, rare pathologies may result in prolonged symptoms. Hiccups can be disruptive and uncomfortable, leading many to seek management strategies using common home remedies. Few methods for terminating hiccups have been published in the scientific literature. We report the efficacy of the Hiccup relief using Active Prolonged Inspiration (HAPI) technique, which combines phrenic and vagal nerve stimulation with transient hypercapnia for hiccup relief. Methods Twenty patients with self-limited hiccups and one patient with prolonged hiccups were successful in eliminating hiccups using HAPI. In this method, patients are instructed to inspire maximally. Once at the peak of inspiration, they continue to attempt to inspire with an open glottis for a total of 30 seconds. This is followed by a slow expiration and resumption of normal respiration. Results In all cases, patients reported immediate hiccup relief. Conclusion These findings suggest the HAPI technique is a simple and viable method for hiccup relief. Further studies are needed to validate effectiveness.
PubMed: 38410321
DOI: 10.7759/cureus.53045 -
HeartRhythm Case Reports Feb 2024
PubMed: 38404985
DOI: 10.1016/j.hrcr.2023.11.006 -
Chest Feb 2024Electromagnetic stimulation of the phrenic nerve induces diaphragm contractions, but no coils for clinical use have been available. We recently demonstrated the...
BACKGROUND
Electromagnetic stimulation of the phrenic nerve induces diaphragm contractions, but no coils for clinical use have been available. We recently demonstrated the feasibility of ventilation using bilateral transcutaneous noninvasive electromagnetic phrenic nerve stimulation (NEPNS) before surgery in lung-healthy patients with healthy weight in a dose-dependent manner.
RESEARCH QUESTION
Is NEPNS feasible in critically ill patients in an ICU setting?
STUDY DESIGN AND METHODS
This feasibility nonrandomized controlled study aimed to enroll patients within 36 h of intubation who were expected to remain ventilated for ≥ 72 h. The intervention group received 15-min bilateral transcutaneous NEPNS bid, whereas the control group received standard care. If sufficient, NEPNS was used without pressure support to ventilate the patient; pressure support was added if necessary to ventilate the patient adequately. The primary outcome was feasibility, measured as time to find the optimal stimulation position. Further end points were sessions performed according to the protocol or allowing a next-day catch-up session and tidal volume achieved with stimulation reaching only 3 to 6 mL/kg ideal body weight (IBW). A secondary end point was expiratory diaphragm thickness measured with ultrasound from days 1 to 10 (or extubation).
RESULTS
The revised European Union regulation mandated reapproval of medical devices, prematurely halting the study. Eleven patients (five in the intervention group, six in the control group) were enrolled. The median time to find an adequate stimulation position was 23 s (interquartile range, 12-62 s). The intervention bid was executed in 87% of patients, and 92% of patients including a next-day catch-up session. Ventilation with 3 to 6 mL/kg IBW was achieved in 732 of 1,701 stimulations (43.0%) with stimulation only and in 2,511 of 4,036 stimulations (62.2%) with additional pressure support. A decrease in diaphragm thickness was prevented by bilateral NEPNS (P = .034) until day 10.
INTERPRETATION
Bilateral transcutaneous NEPNS was feasible in the ICU setting with the potential benefit of preventing diaphragm atrophy during mechanical ventilation. NEPNS ventilation effectiveness needs further assessment.
TRIAL REGISTRY
ClinicalTrials.gov; No.: NCT05238753; URL: www.
CLINICALTRIALS
gov.
PubMed: 38403186
DOI: 10.1016/j.chest.2024.02.035