Expert review of medical devices最新文献

Introduction: Proactive esophageal cooling reduces injury during radiofrequency (RF) ablation of the left atrium (LA) for the treatment of atrial fibrillation (AF). New catheters are capable of higher wattage settings up to 90 W (very high-power short duration, vHPSD) for 4s. Varying power and duration however does not eliminate the risk of thermal injury. Furthermore, alternative energy sources such as pulsed field ablation (PFA) also exhibit thermal effects, with clinical data showing esophageal temperatures up to 40.3°C. The ensoETM esophageal cooling device (Attune Medical, now a part of Haemonetics, Boston, MA, U.S.A.) is commercially available and FDA-cleared to reduce thermal injury to the esophagus during RF ablation for AF and is recommended in the 2024 expert consensus statement on catheter and surgical ablation of AF.

Areas covered: This review summarizes growing evidence of esophageal cooling during high power RF ablation for AF treatment, including data relating to procedural efficacy, safety, and efficiency, and techniques to enhance operator success while providing directions for further research.

Expert opinion: Proactive esophageal cooling reduces injury to the esophagus during high power RF ablation, and utilizing this approach may result in increased success in first-pass.

Introduction: Out-of-hospital cardiac arrest (OHCA) is characterized by the cessation of mechanical cardiac activity and voluntary circulation occurring outside of a hospital setting, making it the leading cause of death worldwide. Recently, the optimal approach to airway management has been a subject of controversy.

Methods: Follow PRISMA guidelines for systematic evaluation and meta-analysis. The primary outcome was survival assessed by 4 measures: Restoration of spontaneous circulation, survival to hospital or emergency department, evaluation of functional recovery after PCR (measured at both discharge and 3 months after PCR), and neurological function score at discharge.

Results: A total of 6 RCTs (14,205 patients) were included in the systematic review and 4 RCTs (13,053 patients) were included in the meta-analysis. 5 studies (83.3%)of RCTs with ETI controls were notable for their high quality, with low risk of bias judged in all 7 domains of the risk assessment scale. Showed an advantage of SGA (compared to ETI) with potential for ROSC (95% CI [1.02 to 1.18], I² = 48%, p = 0.01) and survival to hospital or emergency department(95% CI [1.01 to 1.17], I² = 12%, p = 0.02).

Conclusions: This systematic review and meta-analysis found a significant association between SGA and the possibility of obtaining ROSC and reaching the hospital or emergency department after CPR in OHCA.

Introduction: The average body mass index (BMI) in the United States has tripled over the last five decades despite concerted population-based efforts for weight management. Elevated BMI and, in particular, obesity are risk factors for osteoarthritis. This trend has led to increased demands for total knee (TKA) and total hip arthroplasty (THA), necessitating an in-depth understanding of how elevated BMI impacts TKA and THA.

Areas covered: This paper reviews the literature investigating the effects of elevated BMI, primarily obesity, on TKA and THA, focusing on preoperative, intraoperative, and postoperative considerations. It describes the associated risks, economic implications, and ethical considerations of patients with high BMIs undergoing TKA or THA. To ensure all relevant literature was included, Ovid Medline and Google Scholar databases were searched for the following terms, 'body mass index,' 'obesity,' 'knee,' 'hip,' and 'arthroplasty' for articles published from January 2019 through July 2024.

Expert opinion: Despite the challenges of high BMI in TKA and THA, a deeper understanding of obesity as a chronic illness, coupled with advances in surgical techniques, can improve patient outcomes. A multidisciplinary approach and further research will optimize the care of patients with elevated BMIs undergoing total joint arthroplasty (TJA).

Introduction: Recently, there has been growing experience with utilizing a veno-arterial extracorporeal membrane oxygenator (VA ECMO) routinely during lung transplantation procedures. Yet, there is a lack of consensus on the protocols, benefits, and outcomes of routine VA ECMO use in lung transplantation.

Areas covered: This article presents an overview of the current status of routine use of VA ECMO during lung transplantation, including rationale, protocols, applications, and outcomes.

Expert opinion: Utilization of VA ECMO during lung transplantation has emerged as an alternative mechanical circulatory support modality to cardiopulmonary bypass, with growing evidence showing lower rates of peri-operative complications. Some groups took that further into routine application of VA ECMO during lung transplantation. The current available evidence suggests that routine utilization of VA ECMO during lung transplantation is associated with lower rates of primary graft dysfunction and improved early outcomes. Use of VA ECMO allows controlled reperfusion of the allograft and avoids an unplanned "crash" on pump in case of hemodynamic instability, which carries worse outcomes after lung transplantation. As a relatively new approach, further follow-up of growing experience, as well as prospective clinical trials, is necessary to develop a consensus about routine utilization of VA ECMO during lung transplantation.

Background: Smartphone electrocardiograms (iECGs) are an innovative method of capturing transient arrhythmias that are occasionally experienced by athletes. This study aimed to assess the accuracy of a 6-lead iECG compared with 12-lead ECG in athletes and those with known genetic heart disease (positive controls).

Research design and methods: Each participant had a resting 12-lead ECG (supine) and a 30 s 6-lead iECG (seated) taken within 2 h. Manual measurements of heart rate, QTc, and PR intervals, and QRS duration were completed using digital calipers. Bland-Altman analysis was used to assess the quantitative agreement of measurements.

Results: The 6-lead readings for heart rate were faster than the 12-lead in athletes (n = 233) and positive controls (n = 49). All other measurements were shorter in the 6-lead. QTc mean difference was smaller in the positive controls (4.7 ± 26.0 ms) than in athletes (12.5 ± 25.0 ms). The largest difference was in PR intervals, both in athletes (12.8 ± 17.7 ms) and positive controls (7.6 ± 18.9 ms). QRS duration had the smallest mean difference (0.6 ± 9.0 ms in athletes, 1.0 ± 12.7 ms in positive controls).

Conclusions: The 6-lead readings had reasonable agreement with the 12-lead ECG. A 6-lead iECG is a reasonable option to opportunistically capture arrhythmias that may occur infrequently, but should not replace a 12-lead if available.

Background: The advent of ultrasonic scalpels has remarkably advanced minimally invasive surgery; however, the Chinese market's reliance on imports highlights the urgent need for a cost-effective, efficient, and domestically produced surgical scalpel. This study aimed to compare SanAgile^TMSA01 with the Johnson & Johnson GEN11, and HAR36 surgical devices.

Research design and methods: In total, 152 participants requiring urological or general laparoscopic surgery were randomly and equally divided between the two hospitals and randomized to the test and control groups. Clinical outcomes, adverse event rates, intraoperative bleeding, and surgery duration were compared between the two devices.

Results: The clinical application rate of both devices was 100%. There were no significant differences between the two groups in intraoperative bleeding, surgery duration, and incidence of adverse events. In the test group, five device-related adverse events occurred (6.58%), compared to two (2.63%) in the control group (no significant difference). The device-related adverse events did not result in any sequelae.

Conclusions: The clinical performance of the SanAgile^TMSA01 was comparable to that of the Johnson & Johnson GEN11 and HAR36. The SanAgile^TMSA01 device may serve as a viable alternative ultrasonic surgical tool, thereby providing clinicians with additional options.

Trial registration: Registration number of Shanghai Medical Equipment Preparation 20,190,114.

Introduction: Implant failures resulting from peri-implant infections can have substantial consequences, underscoring the urgent need for effective strategies to prevent biofilm formation on implant surfaces. However, despite advancements in antimicrobial surface technologies, significant challenges persist in translating these innovations into clinically viable solutions.

Areas covered: This article provides an overview of the limitations of current treatment protocols and explores the potential of antimicrobial surface treatments for controlling such infections. Furthermore, we highlight the importance of balancing antimicrobial efficacy with biocompatibility and mechanical stability, key factors for long-term implant performance. Finally, we address the main challenges in translating these technologies into clinical practice, including the unpredictability of long-term antimicrobial effects, regulatory compliance gaps, and methodological weaknesses in current research.

Expert opinion: The development of antimicrobial surfaces holds promise for enhancing the longevity of dental implants; however, current modifications face persistent challenges, hindering their translation into the dental implant market. Future advancements should prioritize 'smart' or stimulus-responsive surfaces that can release antimicrobials on demand. This strategy aims to efficiently combat infections while minimizing the risks of cytotoxicity and antimicrobial resistance, potentially leading to more effective and clinically translatable solutions.

Introduction: Traditional monitoring of athletes with cardiac symptoms is limited due to sport-specific considerations and the intermittent nature of symptoms. Some portable electrocardiogram (ECG) devices may have more diagnostic utility than traditional monitoring. Their accuracy, advantages, and limitations should be considered when a clinician is considering the most appropriate device for investigation of an athlete's symptoms.

Areas covered: There are six main categories of portable ECG devices: smartwatches, handheld devices, mobile cardiac telemetry (MCT), patches, rings, and chest sensors. The aim of this review is to highlight to a clinician the potential benefits of some devices over others to assist the physician in identifying the most appropriate device. We present peer-reviewed literature on the accuracy of each type of device along with advantages and limitations.

Expert opinion: For a user-initiated capture of an ECG, smartwatches and handheld devices are easy to use and supported by peer-reviewed literature. Rings can also provide a user-initiated ECG, though there is limited evidence to support their usage. For continuous monitoring, patches and MCT are both useful, though there is limited access to these devices. Chest sensors show some promise, although access is currently limited in some countries.