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Abstract Background (Rationale/Purpose/Objective) Resuscitative endovascular balloon occlusion of the aorta (REBOA) is used to temporary control non-compressible truncal hemorrhage (NCTH) as bridge to definitive surgical treatment. The dependence on radiography for safe balloon positioning is one factor that limits the extended use of REBOA in civilian and military pre-hospital settings. We aimed to determine standardized sex and age-based variable-distance catheter insertion lengths for accurate REBOA placement without initial fluoroscopic confirmation. Methods Contrast enhanced CT-scans from a representative sample of a Dutch non-trauma population were retrospectively analyzed. Intravascular distances were measured from the bilateral common femoral artery access points (FAAP) to the middle of the aortic occlusion zones and accompanying boundaries. Means and 95% confidence intervals for the distances from the FAAPs to the boundaries and mid-zone III were calculated for all (combined) sex and age-based subgroups. Optimal insertion lengths and potentially safe regions were determined for these groups. Bootstrap analysis was performed in combination with a 40-mm long balloon introduction simulation to determine error-rates and REBOA placement accuracy for the general population. Results In total, 1354 non-trauma patients (694 females) were included. Vascular distances increased with age and were longer in males. The iliofemoral trajectory was 7 mm longer on the right side. The optimal zone I catheter insertion length would be 430 mm. Optimal zone III catheter insertion lengths showed up to 30 mm difference, ranging between 234 and 264 mm. Statistically significant and potentially clinically relevant differences were observed between the anatomical distances and necessary introduction depths for each subgroup. Conclusion This is the first study to compare aortic morphology and intravascular distances between combined sex and age-based subgroups. As zone III length was consistent, length variability and elongation seem to mainly originate in the iliofemoral trajectory and zone II. The optimal zone I catheter insertion length would be 430 mm. Optimal zone III catheter insertion ranged between 234 and 264 mm. These standardized variable-distance insertion lengths could facilitate safer fluoroscopy-free REBOA in austere, pre-hospital settings.

Background (Rationale/Purpose/Objective): Resuscitative endovascular balloon occlusion of the aorta (REBOA) is used to temporary control non-compressible truncal hemorrhage (NCTH) as bridge to definitive surgical treatment. The dependence on radiography for safe balloon positioning is one factor that limits the extended use of REBOA in civilian and military pre-hospital settings. We aimed to determine standardized sex and age-based variable-distance catheter insertion lengths for accurate REBOA placement without initial fluoroscopic confirmation. Methods: Contrast enhanced CT-scans from a representative sample of a Dutch non-trauma population were retrospectively analyzed. Intravascular distances were measured from the bilateral common femoral artery access points (FAAP) to the middle of the aortic occlusion zones and accompanying boundaries. Means and 95% confidence intervals for the distances from the FAAPs to the boundaries and mid-zone III were calculated for all (combined) sex and age-based subgroups. Optimal insertion lengths and potentially safe regions were determined for these groups. Bootstrap analysis was performed in combination with a 40-mm long balloon introduction simulation to determine error-rates and REBOA placement accuracy for the general population. Results: In total, 1354 non-trauma patients (694 females) were included. Vascular distances increased with age and were longer in males. The iliofemoral trajectory was 7 mm longer on the right side. The optimal zone I catheter insertion length would be 430 mm. Optimal zone III catheter insertion lengths showed up to 30 mm difference, ranging between 234 and 264 mm. Statistically significant and potentially clinically relevant differences were observed between the anatomical distances and necessary introduction depths for each subgroup. Conclusion: This is the first study to compare aortic morphology and intravascular distances between combined sex and age-based subgroups. As zone III length was consistent, length variability and elongation seem to mainly originate in the iliofemoral trajectory and zone II. The optimal zone I catheter insertion length would be 430 mm. Optimal zone III catheter insertion ranged between 234 and 264 mm. These standardized variable-distance insertion lengths could facilitate safer fluoroscopy-free REBOA in austere, pre-hospital settings. [ABSTRACT FROM AUTHOR]

Abstract Background and Aims Fluoroscopy‐free endoscopic retrograde cholangiopancreatography for common bile duct stone (CBDS) clearance is usually offered only to pregnant patients. We initiated a multicenter, randomized controlled trial comparing clearance of non‐complex CBDSs using fluoroscopy‐free direct solitary cholangioscopy (DSC) to standard endoscopic retrograde cholangiography (ERC) to evaluate the wider applicability of the DSC‐based approach. Here we report the initial results of stone clearance and safety in roll‐in cases for the randomized controlled trial. Methods Twelve expert endoscopists at tertiary care centers in four countries prospectively enrolled 47 patients with non‐complex CBDSs for DSC‐assisted CBDS removal in an index procedure including fluoroscopy‐free cannulation. Successful CBDS clearance was first determined by DSC and subsequently validated by final occlusion cholangiogram as the ERC gold standard. Results Fully fluoroscopy‐free cannulation was successful in 42/47 (89.4%) patients. Brief fluoroscopy with minimal contrast injection was used in 4/47 (8.5%) patients during cannulation. Cannulation failed in 1/47 (2.1%) patients. Fluoroscopy‐free complete stone clearance was reached in 38/46 (82.6%) cases. Residual stones were detected in the validation ERC occlusion cholangiogram in three cases. Overall serious adverse event rate was 2.1% (95% confidence interval 0.1–11.3): postprocedural pancreatitis in one patient. Conclusions In patients with non‐complex CBDS, the fluoroscopy‐free technique is easily transferred to endoscopic retrograde cholangiopancreatography experts with acceptable rates of cannulation and stone clearance and few serious adverse events. (ClinicalTrials.gov number, NCT03421340)

Aim: Fluoroscopy is used in some stages of the conventional Retrograde Intrarenal Surgery (RIRS) procedure and is beneficial. On the other hand, radiation exposure is its most obvious disadvantage. As a subgroup, we aimed to show that fluoroscopy-free technique is safe and effective in patients who underwent RIRS after passive dilatation. Materials and methods: Between October 2018 and April 2020, 54 cases of second session RIRS of renal stones performed by a single surgeon were retrospectively evaluated. Patients' demographic characteristics (age, gender), stone features (laterality, size, number, volume, and location), mean operative time, and, perioperative and postoperative complications, as well as the stone-free rate (SFR), were all retrospectively evaluated. The results were classified as stone free, clinical insignificant residual fragments (CIRF), and presence of residual stones. Complications were graded using the Clavien–Dindo classification system. We used a modified surgical technique. Results: All of complications were minor. There were no major complications (Clavien grade III–IV). The stone-free rate was 70.3% (38/54) on the first day after surgery and 83.3% (45/54) 1 month afterward, respectively. If we accept the absence of residual stone as success, we can say that it is about 91% successful in the first month. Conclusion: This technique has a high stone-free success rate and a low complication rate without the use of radiation. For surgeons experienced in endourology, we can say that the fluoroscopy-free technique is safe and effective in secondary-session RIRS cases which passive dilatation was performed by inserting a ureteral catheter before. [ABSTRACT FROM AUTHOR]

Abstract Objective Pulmonary vein isolation (PVI) is the cornerstone of the interventional treatment of atrial fibrillation (AF). Traditionally, during these procedures the catheters are guided by fluoroscopy, which poses a risk to the patient and staff by ionizing radiation. Our aim was to describe our experience in the implementation of an intracardiac echocardiography (ICE) guided zero fluoroscopic (ZF) ablation approach to our routine clinical practice. Methods We developed a simplified ICE guided technique to perform ablation procedures for AF, with the aid of a 3D electroanatomical mapping system. The workflow was implemented in two phases: (1) the Introductory phase, where the first 16 ZF PVIs were compared with 16 cases performed with fluoroscopy and (2) the Extension phase, where 71 consecutive patients (including repeat procedures) with ZF approach were included. Standard PVI (and redoPVI) procedures were performed, data on feasibility of the ZF approach, complications, acute and 1-year success rates were collected. Results In the Introductory phase, 94% of the procedures could be performed with complete ZF with a median procedure time of 77.5 (73.5–83) minutes. In one case fluoroscopy was used to guide the ICE catheter to the atrium. There was no difference in the complication, acute and 1-year success rates, compared with fluoroscopy guided procedures. In the Extension phase, 97% of the procedures could be completed with complete ZF. In one case fluoroscopy was used to guide the transseptal puncture and in another to position the ICE catheter. Acute success of PVI was achieved in all cases, 64.4% patients were arrhythmia free at 1-year. Acute major complications were observed in 4 cases, all of these occurred in the redo PVI group and consisted of 2 tamponades, 1 transient ischemic attack and 1 pseudoaneurysm at the puncture site. The procedures were carried out by all members of the electrophysiology unit in the Extension phase, including less experienced operators and electrophysiology fellows (3 physicians) under the supervision of the senior electrophysiologist. Consequently, procedure times became longer [90 (75–105) vs 77.5 (73.5–85) min, p = 0.014]. Conclusions According to our results, a ZF workflow of AF ablations can be successfully implemented into the routine practice of an electrophysiology laboratory, without compromising safety and effectivity.

Objective: Pulmonary vein isolation (PVI) is the cornerstone of the interventional treatment of atrial fibrillation (AF). Traditionally, during these procedures the catheters are guided by fluoroscopy, which poses a risk to the patient and staff by ionizing radiation. Our aim was to describe our experience in the implementation of an intracardiac echocardiography (ICE) guided zero fluoroscopic (ZF) ablation approach to our routine clinical practice.Methods: We developed a simplified ICE guided technique to perform ablation procedures for AF, with the aid of a 3D electroanatomical mapping system. The workflow was implemented in two phases: (1) the Introductory phase, where the first 16 ZF PVIs were compared with 16 cases performed with fluoroscopy and (2) the Extension phase, where 71 consecutive patients (including repeat procedures) with ZF approach were included. Standard PVI (and redoPVI) procedures were performed, data on feasibility of the ZF approach, complications, acute and 1-year success rates were collected.Results: In the Introductory phase, 94% of the procedures could be performed with complete ZF with a median procedure time of 77.5 (73.5-83) minutes. In one case fluoroscopy was used to guide the ICE catheter to the atrium. There was no difference in the complication, acute and 1-year success rates, compared with fluoroscopy guided procedures. In the Extension phase, 97% of the procedures could be completed with complete ZF. In one case fluoroscopy was used to guide the transseptal puncture and in another to position the ICE catheter. Acute success of PVI was achieved in all cases, 64.4% patients were arrhythmia free at 1-year. Acute major complications were observed in 4 cases, all of these occurred in the redo PVI group and consisted of 2 tamponades, 1 transient ischemic attack and 1 pseudoaneurysm at the puncture site. The procedures were carried out by all members of the electrophysiology unit in the Extension phase, including less experienced operators and electrophysiology fellows (3 physicians) under the supervision of the senior electrophysiologist. Consequently, procedure times became longer [90 (75-105) vs 77.5 (73.5-85) min, p = 0.014].Conclusions: According to our results, a ZF workflow of AF ablations can be successfully implemented into the routine practice of an electrophysiology laboratory, without compromising safety and effectivity. [ABSTRACT FROM AUTHOR]

Introduction: We report a case of a fetus with complex congenital heart disease and supraventricular tachycardia in the setting of maternal high grade atrioventricular block at 26 weeks' gestation. Methods and results: Electroanatomic mapping allowed successful implantation of a permanent pacemaker to provide adequate back‐up pacing in the mother with zero radiation exposure, thus allowing safe delivery of transplacental anti‐arrhythmic medications to reduce the fetal arrhythmia burden and optimize the fetal ventricular rate. Conclusion: This is the first reported case of using electroanatomic mapping, with zero fluoroscopy use, for pacemaker lead placement and for a novel indication. [ABSTRACT FROM AUTHOR]

Introduction: Non-compressible torso hemorrhage accounts for 70% of battlefield deaths. Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an emerging technology used to mitigate massive truncal hemorrhage. Use of REBOA on the battlefield is limited by the need for radiographic guided balloon placement. Radiofrequency identification (RFID) is a simple, portable, real-time technology utilized to detect retained sponges during surgery. We investigated the feasibility of RFID to confirm the placement of ER-REBOA.Materials and Methods: This was a single-arm prospective proof-of-concept experimental study approved by the institutional review board at Naval Medical Center San Diego. The ER-REBOA (Prytime Medical Devices, Inc, Boerne, TX, USA) was modified by placement of a RFID tag. The tagged ER-REBOA was placed in zone I or zone III of the aorta in a previously perfused cadaver. Exact location was documented with X-ray. Five blinded individuals used the RF Assure Detection System (Medtronic, Minneapolis, MN, USA) handheld detection wand to predict catheter tip location from the xiphoid process (zone I) or pubic tubercle (zone III).Results: In zone I, actual distance (Da) of the catheter tip was 11 cm from the xiphoid process. Mean predicted distance (Dp) from Da was 1.52 cm (95% CI 1.19-1.85). In zone III, Da was 14 cm from the pubic tubercle. Mean Dp from Da was 4.11 cm (95% CI 3.68-4.54). Sensitivity of detection was 100% in both zones. Specificity (Defined as Dp within 2 cm of Da) was 86% in zone I and 16% in zone III.Conclusions: Using RFID to confirm the placement of ER-REBOA is feasible with specificity highest in zone I. Future work should focus on refining this technology for the forward-deployed setting. [ABSTRACT FROM AUTHOR]

Background and Aims: Fluoroscopy-free endoscopic retrograde cholangiopancreatography for common bile duct stone (CBDS) clearance is usually offered only to pregnant patients. We initiated a multicenter, randomized controlled trial comparing clearance of non-complex CBDSs using fluoroscopy-free direct solitary cholangioscopy (DSC) to standard endoscopic retrograde cholangiography (ERC) to evaluate the wider applicability of the DSC-based approach. Here we report the initial results of stone clearance and safety in roll-in cases for the randomized controlled trial., Methods: Twelve expert endoscopists at tertiary care centers in four countries prospectively enrolled 47 patients with non-complex CBDSs for DSC-assisted CBDS removal in an index procedure including fluoroscopy-free cannulation. Successful CBDS clearance was first determined by DSC and subsequently validated by final occlusion cholangiogram as the ERC gold standard., Results: Fully fluoroscopy-free cannulation was successful in 42/47 (89.4%) patients. Brief fluoroscopy with minimal contrast injection was used in 4/47 (8.5%) patients during cannulation. Cannulation failed in 1/47 (2.1%) patients. Fluoroscopy-free complete stone clearance was reached in 38/46 (82.6%) cases. Residual stones were detected in the validation ERC occlusion cholangiogram in three cases. Overall serious adverse event rate was 2.1% (95% confidence interval 0.1-11.3): postprocedural pancreatitis in one patient., Conclusions: In patients with non-complex CBDS, the fluoroscopy-free technique is easily transferred to endoscopic retrograde cholangiopancreatography experts with acceptable rates of cannulation and stone clearance and few serious adverse events. (ClinicalTrials.gov number, NCT03421340)., Competing Interests: The authors disclose the following:Wiriyaporn Ridtitid: Research support from Boston Scientific CorporationRungsun Rerknimitr: Research support from Boston Scientific CorporationMohan Ramchandani: No disclosuresSundeep Lakhtakia: No disclosuresRaj J Shah: Consultant for Boston Scientific Corporation and OlympusJanak N Shah: Research support from Boston Scientific CorporationNirav Thosani: Consultant for Boston Scientific Corp, Pentax America, Ambu Inc; Speaker for Abbvie; Royalty from UpToDate; Creatorship Rights for ROSEAid IncMahesh K Goenka: no disclosuresGuido Costamagna: Research grants from Cook Medical and Boston Scientific, Advisory Board Grant from OlympusMihir S Wagh: Consultant for Boston Scientific, Olympus, Medtronic, Fujifilm, ConMed and Incyte; Research support from SterisVincenzo Perri: No financial relationships with a commercial entity producing health‐care‐related products and/or services relevant to this article.Joyce Peetermans: Full‐time employee of Boston Scientific CorporationPooja G Goswamy: Full‐time employee of Boston Scientific CorporationZoe Liu: Full‐time employee of Boston Scientific Corporation at the time of this studySrey Yin: Full‐time employee of Boston Scientific Corporation at the time of this studySubhas Banerjee: Boston Scientific: Consultant and research support; Ambys Medicines: consultant, (© 2023 The Authors. DEN Open published by John Wiley & Sons Australia, Ltd on behalf of Japan Gastroenterological Endoscopy Society.)

During the treatment of tibia fracture with interlocking nails, the most uncomfortable procedure is for an orthopaedic surgeon to find the location for the distal locking screws. In this study, a fluoroscopy-free non-contact navigation device was developed for the placement of distal locking screws in the tibia intramedullary nailing. This device utilizes a 3D digitization arm integrated with spatial coordinate registration module, graphical user interface module and sound-guided navigation module. The 3D digitization arm, a five-DOF passive robotic arm, was used to register the spatial coordinates of proximal and distal landmarks just before placement of the nail. The registered coordinates were then incorporated with the coordinates of the proximal landmarks after nail placement to calculate the coordinate transformation matrix. The transformed spatial coordinates of the distal screw holes were then computed in real time for interlocking nail navigation. A sound-guided navigation module was designed in which a sound with different tones and intermittence frequencies was produced, as the probe of the digitization arm navigates toward the location of distal screw holes. No intra-operative fluoroscopy was required. In vitro assessment was performed successfully with a donor bone, and a clinical case of a young male with tibia fracture was also carried out in the operating theatre. Operation time, distal screw insertion, total radiation time and accuracy of the distal interlocking screw placement were measured. The surgery was conducted under sterile conditions without complication, and the clinical course was smooth with prompt bone healing. [ABSTRACT FROM AUTHOR]

Background: Central screw positioning in the scaphoid provides biomechanical advantages., Methods: A prospective randomized study of six fluoroscopically guided and six electromagnetically navigated screw (ENS) placements was performed on human cadavers. Accuracy of screw position was determined. Intraoperative fluoroscopy exposure times, readjustments of drilling directions, complete restarts and complications were documented., Results: The ENS method provided a mean time benefit of 7.34 min compared with the standard method and the mean screw length ratio (SLR coronar: ENS 0.96 ± 0.04 mm, SFF: 0.92 ± 0.04 mm, P = 0.065; SLR sagittal: ENS 0.98 ± 0.02 mm, SFF: 0.91 ± 0.04 mm, P = 0.009) and the screw axis deviation angle (AD coronar: ENS 3.33 ± 2.34°, SFF: 10.33 ± 2.58°, P = 0.002; AD sagittal: ENS 2.83 ± 0.98°, SFF: 11.00 ± 6.16°, P = 0.002) were lower. Using the electromagnetic navigation procedure no drilling readjustments or restarts were required, no cortical breach occurred., Conclusions: Compared with the standard fluoroscopic technique, the ENS method used in this study showed higher accuracy, less complications, required less operation and radiation exposure time., (Copyright © 2014 John Wiley & Sons, Ltd.)