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550 result(s) for "Balloon Occlusion - adverse effects"
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Randomized Trial of Fetal Surgery for Severe Left Diaphragmatic Hernia
In this trial involving fetuses with severe left congenital diaphragmatic hernia, fetoscopic endoluminal tracheal occlusion at 27 to 29 weeks of gestation significantly increased survival to discharge, but it resulted in an increased incidence of preterm, prelabor rupture of membranes and preterm birth.
Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia
In this randomized trial involving fetuses with moderate left congenital diaphragmatic hernia, fetoscopic endoluminal tracheal occlusion at 30 to 32 weeks of gestation did not significantly increase survival to discharge from a NICU or reduce the need for oxygen supplementation at 6 months, and it increased the risks of preterm, prelabor rupture of membranes and preterm birth. The surgical technique is shown in an animated video.
Effect of resuscitative endovascular balloon occlusion of the aorta in nontraumatic out-of-hospital cardiac arrest: a multinational, multicenter, randomized, controlled trial
Background Out-of-hospital cardiac arrest (OHCA) is a significant public health issue worldwide and is associated with low survival rates and poor neurological outcomes. The generation of optimal coronary perfusion pressure (CPP) via high-quality chest compressions is a key factor in enhancing survival rates. However, it is often challenging to provide adequate CPP in real-world cardiopulmonary resuscitation (CPR) scenarios. Based on animal studies and human trials on improving CPP in patients with nontraumatic OHCA, resuscitative endovascular balloon occlusion of the aorta (REBOA) is a promising technique in these cases. This study aims to investigate the benefits of REBOA adjunct to CPR compared with conventional CPR for the clinical management of nontraumatic OHCA. Methods This is a parallel-group, randomized, controlled, multinational trial that will be conducted at two urban academic tertiary hospitals in Korea and Taiwan. Patients aged 20–80 years presenting with witnessed OHCA will be enrolled in this study. Eligible participants must fulfill the inclusion criteria, and written informed consent should be collected from their legal representatives. Patients will be randomly assigned to the intervention (REBOA-CPR) or control (conventional CPR) group. The intervention group will receive REBOA and standard advanced cardiovascular life support (ACLS). Meanwhile, the control group will receive ACLS based on the 2020 American Heart Association guidelines. The primary outcome is the return of spontaneous circulation (ROSC). The secondary outcomes include sustained ROSC, survival to admission, survival to discharge, neurological outcome, and hemodynamic changes. Discussion Our upcoming trial can provide essential evidence regarding the efficacy of REBOA, a mechanical method for enhancing CPP, in OHCA resuscitation. Our study aims to determine whether REBOA can improve treatment strategies for patients with nontraumatic OHCA based on clinical outcomes, thereby potentially providing valuable insights and guiding further advancements in this critical public health area. Trial registration ClinicalTrials.gov NCT06031623. Registered on September 9, 2023
Effect of ischemic postconditioning on myocardial salvage in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: cardiac magnetic resonance substudy of the POST randomized trial
In the effects of postconditioning on myocardial reperfusion in patients with ST-segment elevation myocardial infarction (POST) trial, ischemic postconditioning did not improve myocardial reperfusion in 700 patients with STEMI undergoing primary PCI. However, the impact of postconditioning on myocardial salvage and infarct size still needs to be addressed. The aim of this study was to investigate the effect of ischemic postconditioning on myocardial salvage using cardiac magnetic resonance (CMR) in patients with STEMI undergoing primary PCI. For the CMR substudy, a total of 111 patients was analyzed, 56 in the postconditioning group and 55 undergoing conventional primary PCI in the control group. Postconditioning was performed immediately after restoration of coronary flow by four cycles of 1-min balloon occlusion separated by 1 min of deflation. The primary end point was myocardial salvage measured by CMR 3 days after the index event. The myocardial salvage index was not improved by ischemic postconditioning compared with conventional PCI (46.3 ± 18.5 vs. 45.7 ± 20.5 %, p  = 0.86). The infarct size was not significantly different between the two groups (18.8 ± 10.3 vs. 20.2 ± 11.0 %, p  = 0.52). Moreover, there was no significant difference in the rates of microvascular obstruction or hemorrhagic infarction between the groups. CMR study demonstrated that ischemic postconditioning during primary PCI in STEMI patients did not improve myocardial salvage or reduce infarct size. These findings further support the results of the POST trial which showed no benefit of ischemic postconditioning as an adjunctive treatment of primary PCI.
Anesthetic management of cesarean section in cases of placenta accreta, with versus without abdominal aortic balloon occlusion: study protocol for a randomized controlled trial
Background Placenta accreta (PA), a severe complication during delivery, is closely linked with massive hemorrhage which could endanger the lives of both mother and baby. Moreover, the incidence of PA has increased dramatically with the increasing rate of cesarean deliveries in the past few decades. Therefore, studies evaluating the effects of different perioperative managements based on different modalities in the treatment of PA are necessary. Among the numerous treatment measures, prophylactic abdominal aortic balloon occlusion (AABO) in combination with cesarean section for PA seems to be more advantageous than others. However, up to now, all studies on AABO were almost retrospective. Current evidence is insufficient to recommend for or against routinely using the AABO technology for control intraoperative hemorrhage in patients with PA. Thus, we hope to carry out a prospective, randomized controlled trial (RCT) study to confirm the effectiveness of the AABO technology in patients with PA. Methods/design This trial is an investigator-initiated, prospective RCT that will test the superiority of AABO in combination with cesarean section compared to the traditional hysterectomy following cesarean section for parturients with PA. A total of 170 parturients with PA undergoing cesarean section will be randomized to receive either AABO in combination with cesarean section or the traditional hysterectomy following cesarean section. The primary outcome is estimated blood loss. The most important secondary outcome is the occurrence of cesarean hysterectomy during delivery; others include blood transfusion volume, operating time, neonate’s Apgar scores (collected at 1, 5 and 10 min), length of stay in intensive care unit, total hospital stay, and balloon occlusion-relative data. Discussion This prospective trial will test the superiority of AABO in combination with cesarean section compared to the traditional hysterectomy following cesarean section for parturients with PA. It may provide strong evidence about the benefits and risks of AABO in combination with cesarean section for parturients with PA. Trial registration Chinese Clinical Trial Registry, ChiCTR-INR-16008842 . Registered on 14 July 2016.
Percutaneous Balloon Compression vs Percutaneous Retrogasserian Glycerol Rhizotomy for the Primary Treatment of Trigeminal Neuralgia
Abstract BACKGROUND: Despite >30 years of clinical use, the literature is still sparse when it comes to comparisons between percutaneous balloon compression (PBC) and percutaneous retrogasserian glycerol rhizolysis (PRGR) as treatments for trigeminal neuralgia. OBJECTIVE: To perform a retrospective cohort comparison between PBC and PRGR with regard to therapeutic effect, side effects, and complications. METHODS: Medical records and follow-up data from 124 primary PRGRs performed from 1986 to 2000 and 82 primary PBCs performed from 2000 to 2013 were reviewed. All patients had undergone clinical sensory testing and assessment of sensory thresholds. Analyses were performed to compare duration of pain relief, frequency of sensory disturbances, and side effects. RESULTS: Median duration of pain relief was 21 months after PRGR and 20 months after PBC. Both methods carried a high risk of hypesthesia/hypalgesia (P < .001) that was partly reversed with time. Decreased corneal sensibility was common after PRGR (P < .001) but not after PBC. Dysesthesia was more common after PRGR (23%) compared after PBC (4%; P < .001). Other side effects were noted but uncommon. CONCLUSION: PBC and PRGR are both effective as primary surgical treatment of trigeminal neuralgia. Both carry a risk of postoperative hypesthesia, but in this series, the side effect profile favored PBC. Furthermore, PBC is technically less challenging, whereas PRGR requires fewer resources. Between these 2 techniques, we propose PBC as the primary surgical technique for percutaneous treatment of trigeminal neuralgia on the basis of its lower incidence of dysesthesia, corneal hypesthesia, and technical failures.
The complications associated with Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA)
Non-compressible torso hemorrhage (NCTH) remains a significant cause of morbidity and mortality in the field of trauma and emergency medicine. In recent times, there has been a resurgence in the adoption of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for patients who present with NCTH. Like all medical procedures, there are benefits and risks associated with the REBOA technique. However, in the case of REBOA, these complications are not unanimously agreed upon with varying viewpoints and studies. This article aims to review the current knowledge surrounding the complications of the REBOA technique at each step of its application.
REBOA in trauma and the risk of venous thromboembolic complications: A matched-cohort study
Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) has been used as a damage control procedure in trauma patients. We hypothesized that REBOA increases risk of venous thromboembolic (VTE) complications. This was an American College of Surgeons Trauma Quality Improvement Program (ACS-TQIP) database study. Excluded were transfers, deaths within 24 h, and severe head injuries. Included were trauma patients receiving REBOA within 4 h from arrival. Outcomes in the two groups were compared after using propensity score matching (PSM) for demographic and clinical characteristics, body area abbreviated injury scale, injury severity score, pelvis and lower extremity fractures, angiographic intervention, preperitoneal pelvic packing, pharmacological VTE prophylaxis, laparotomy, laparotomy and specific orthopedic procedures. After PSM, 339 REBOA patients were matched with 663 patients with No REBOA. REBOA patients were significantly more likely to develop pulmonary embolism (PE) (5.3% vs. 2.7%, p = .037) and VTE (14.7% vs. 10.0%, p = .025). REBOA is associated with an increased risk of PE and VTE complications. Patients managed with REBOA should receive adequate thromboprophylaxis and be monitored closely for VTE complications. [Display omitted] •REBOA in trauma patients:•Higher incidence of venous thromboembolic complications.•Higher incidence of pulmonary embolism.•Higher incidence acute kidney injuries.
Crossover balloon occlusion technique for access closure during transcatheter aortic valve implantation: a multicenter observational study
The ProGlide system represents the most common approach to close the main access site during transcatheter aortic valve implantation (TAVI). A crossover balloon occlusion technique (CBOT) has been reported in small case-series to possibly provide a controlled, safe, and successful hemostasis during TAVI. We sought to investigate the comparative performance of a combined (CBOT + ProGlide) compared with a ProGlide only approach. Primary endpoint was VARC-3 type ≥ 2 bleeding. Secondary outcomes included red blood cells transfusion, vascular complications, acute kidney injury (AKI), length of hospital stay (LOS), and death. Our study retrospectively included 229 consecutive patients admitted to “Villa Verde” Clinic (Taranto, Italy) and “Mater Dei” Hospital (Bari, Italy) and treated with TAVI. The study population was divided based on the access closure strategy in two groups: the combined and the ProGlide suture only group. The CBOT + ProGlide treated group presented lower incidence of primary endpoint, as well as less red blood cells transfusions, AKI stages ≥ 2, and shorter LOS. After propensity-score matching, the CBOT + ProGlide group confirmed lower incidence of primary endpoint (2 (2.4%) vs. 10 (11.9%), p  = 0.016), of AKI stage ≥ 2 (0 vs. 5 (6%), p  = 0.029), and shorter LOS (6.9 ± 4.0 vs. 8.9 ± 6.1, p  = 0.015); moreover, the multivariate logistic regression analysis confirmed the protective role of the combined approach against VARC-3 type ≥ 2 bleeding (CI 0.04–0.99; OR 0.2; p  = 0.05). Data from this multicenter comparative study highlight that a routinary percutaneous closure of the main TAVI access with ProGlide coupled with CBOT is possible and safe. Moreover, this combined approach seems promising in terms of reduced bleeding, RBC transfusions, AKI incidence, and shortening of hospitalizations.
Development of a novel scoring system to determine the optimal timing of esophagogastroduodenoscopy following portosystemic shunt occlusion
Balloon-occluded retrograde transvenous obliteration (BRTO) is a safe and effective treatment for gastric varices (GV) and refractory hepatic encephalopathy (HE) associated with portosystemic shunt (PSS). However, esophageal varices (EV) worsening after BRTO is a major, postoperative complication. This study aimed to develop a novel scoring system for predicting EV deterioration following PSS occlusion and to determine the optimal timing for esophagogastroduodenoscopy (EGD) after the operation for patients with portal hypertension. We retrospectively analyzed data from 76 patients with PSS who underwent BRTO for GV or refractory HE [male/female = 39/37; Child-Pugh class A/B/C = 37/32/7; mean Hepatic venous pressure gradient = 10.8 mmHg] at our institution between April 2008 and March 2021. Factors associated with EV deterioration after BRTO were identified statistically. Cumulative rates of EV deterioration were determined using the Kaplan-Meier method. During a median follow-up period of 18.0 months, 50 patients experienced EV deterioration. The median time to EV deterioration was 23.4 months. Cumulative rates of EV deterioration at 12, 24, and 36 months were 35.5%, 51.5%, and 58.1%, respectively. Multivariate analysis using a Cox proportional hazards model identified male sex ( p = 0.013), a preoperative platelet count ≤ 8.3x10⁴/μL ( p = 0.032), and presence of EV before BRTO ( p = 0.029) as significant independent risk factors for postoperative EV deterioration. Based on these three factors, we developed a novel scoring system ranging from 0–3 points. Median time to EV deterioration for scores 0, 1, 2, and 3 was unreached, 19.2, 10.2, and 6.5 months, respectively. Post-BRTO EV deterioration can be predicted using three factors: male sex, a preoperative platelet count ≤ 8.3x10⁴/μL, and the presence of EV before BRTO. This novel scoring system provides a structured approach for determining the optimal timing of EGD after BRTO, allowing risk stratification, improved postoperative patient management, early detection of EV deterioration, and timely endoscopic intervention for high-risk varices.