Expert Review of Medical Devices最新文献

Objectives: In conventional endoscopic retrograde cholangiopancreatography (ERCP), the patient lies prone or in a semi-prone position under deep sedation and maintains spontaneous ventilation. Sedative-induced respiratory depression and unprotected airway compromise patients' safety. The gastro-laryngeal tube (G-LT) is a novel reusable supraglottic airway device with two separate ports for endoscopy and ventilation. This study attempts to evaluate the performance characteristic of G-LT.

Methods: One hundred and forty patients undergoing ERCP were enrolled and randomized. In Group G, patients underwent ERCP with G-LT, whereas Group S patients underwent ERCP conventionally. G-LT insertion attempts, esophageal visualization times, vital parameters, propofol consumption, endoscopists' and anesthesiologists' satisfaction scores, time to achieve Modified Aldrete Score of ≥ 9, and complications were recorded.

Results: Both groups showed similar demographic parameters and 100% procedure completion rates. G-LT group showed shortened esophageal visualization times (4.71 ± 1.687 s vs 7.37 ± 1.515 s) and increased propofol consumption (423.14 ± 106.982 mg vs 178.00 ± 100.125 mg). Group G showed better endoscopic maneuvrability and lesser hemodynamic variability. Sore throat, dysphagia, and mucosal trauma were higher in the G-LT group.

Conclusion: G-LT provides less intra-procedural hemodynamic changes, quicker esophageal visualization, and better scope maneuvrability at the cost of higher propofol consumption, sore throat, dysphagia, and mucosal trauma.

Trial registration: Clinical Trial Registry of India CTRI/2021/06/034212 (Registered on: 14/06/2021).

Introduction: Endovascular aneurysm repair (EVAR) has rapidly become the preferred management of abdominal aortic aneurysm (AAA). Sac regression status post-EVAR has been linked to clinical outcomes as well as the choice of EVAR device. The aim of this narrative review is to investigate the relationship between sac regression and clinical outcomes post-EVAR in AAA. Another aim is to compare sac regression achieved with the main EVAR devices.

Areas covered: We carried out a comprehensive literature search on multiple electronic databases. Sac regression was usually defined as a decrease in the sac diameter (>10 mm) over follow-up. This revealed that individuals who had sac regression post-EVAR had significantly lower mortality, and higher event-free survival rates. Further, lower rates of endoleak and reintervention were observed in patients with regressing aneurysm sacs. Sac regression patients also had significantly lower odds of rupture compared to counterparts with stable or expanded sacs. The choice of EVAR device was also shown to impact regression, with the Fenestrated Anaconda showing favorable results.

Expert opinion: Sac regression post-EVAR in AAA is an important prognostic factor as it translates to improved mortality and morbidity. Therefore, this relationship must be seriously taken into consideration during follow-up.

Introduction: Pacemaker-dependent (PM) patients with cardiac implantable electronic device (CIED) infection require implantation of a temporary-pacemaker (TP) and delayed endocardial reimplantation or implantation of an epicardial-pacing-system (EPI) before device extraction. Our aim was to compare the TP and EPI-strategy after CIED extraction through a meta-analysis.

Methods: We searched electronic databases up to 25 March 2022, for observational studies that reported clinical outcomes of PM-dependent patients implanted with TP or EPI-strategy after device extraction.

Results: 3 studies were included enrolling 339 patients (TP: 156 patients; EPI: 183 patients). TP compared to EPI showed reduction in the composite outcome of relevant complications (all-cause death, infections, need for revision or upgrading of the reimplanted CIED) (12.1% vs 28.9%; RR: 0.45; 95%CI: 0.25-0.81; p = 0.008) and a trend in reduction of all-cause death (8.9% vs 14.2%; RR: 0.58; 95%CI: 0.33-1.05; p = 0.07). Furthermore, TP-strategy proved to reduce need of upgrading (0% vs 12%; RR: 0.07; 95%CI: 0.01-0.52; p = 0.009), reintervention on reimplanted CIED (1.9% vs 14.7%; RR: 0.15; 95%CI: 0.05-0.48; p = 0.001) and significant increase in pacing threshold (0% vs 5.4%; RR: 0.17; 95%CI: 0.03-0.92; p = 0.04), with a longer discharge time (MD: 9.60 days; 95%CI: 1.98-17.22; p = 0.01).

Conclusion: TP-strategy led to a reduction of the composite outcome of all-cause death and complications, upgrading, reintervention on reimplanted CIED, and risk of increase in pacing threshold compared to EPI-strategy, with longer discharge time.

Introduction: Endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR) are established techniques to treat abdominal aortic aneurysms (AAA) and thoracic aortic aneurysms (TAA). However, there are limitations when challenging proximal neck anatomy is present. Heli-FX EndoAnchors have been used in addition to EVAR and TEVAR to improve proximal sealing of a stent-graft, but there are limited data available on their outcomes, safety, and efficacy.

Areas covered: The properties and development of Heli-FX EndoAnchors are evaluated. The evidence of various clinical outcomes, safety, and efficacy is interrogated with the augmented use of Heli-FX EndoAnchors with EVAR or TEVAR.

Expert opinion: Challenging proximal neck anatomy can be problematic during EVAR or TEVAR. EndoAnchors may be part of the solution - used either prophylactically or therapeutically. The safety and efficacy databases are building but long-term data are still not available for this device and there remains inadequate data to support its routine use. Judicious patient selection is still needed.

Introduction: Endoscopic spine surgery techniques are minimally invasive alternatives to conventional open surgery for degenerative spinal diseases. Clinical studies and meta-analyses have proven the usefulness of uniportal full-endoscopic spine procedures. However, a steep learning curve is a critical barrier for endoscopic procedures. Recently, biportal endoscopic spine surgeries have been developed to make it easier for spine surgeons to learn and perform. Consequently, the biportal approach has gained popularity among aspiring endoscopic spine surgeons. This review compared the characteristics of uniportal and biportal surgeries to help spine surgeons perform endoscopic procedures more effectively.

Area covered: The review analyzed English-language clinical literature in Core databases and compared uniportal and biportal endoscopic spine surgery techniques. Clinical studies have compared the technical principles of both techniques, and the authors suggested appropriate strategies for learning and practicing endoscopic procedures.

Expert opinion: Uniportal, full-endoscopic spine surgery is a minimally invasive procedure that preserves muscles and uses a keyhole approach under local anesthesia. In contrast, biportal surgery is more familiar to a surgeon and can be performed more widely, although the keyhole approach is limited. Aspiring endoscopic spine surgeons can learn either method according to the surgeon's preference and the clinical situation.