Medtronic (China)

Left bundle branch area pacing (LBBAP) has emerged as an alternative to biventricular pacing (BVP) for cardiac resynchronization therapy (CRT). We aimed to compare the morbidity and mortality associated with LBBAP versus BVP in patients undergoing CRT implantation. Consecutive patients who received CRT from two high-volume implantation centers were retrospectively recruited. The primary endpoint was a composite of all-cause death and heart failure hospitalization, and the secondary endpoint was all-cause death. A total of 491 patients receiving CRT (154 via LBBAP and 337 via BVP) were included, with a median follow-up of 31months. The primary endpoint was reached by 21 (13.6%) patients in the LBBAP group, as compared with 74 (22.0%) patients in the BVP group [hazard ratio (HR) 0.70, 95% confidence interval (CI) 0.43-1.14, P = 0.15]. There were 10 (6.5%) deaths in the LBBAP group, as compared with 31 (9.2%) in the BVP group (HR 0.91, 95% CI 0.44-1.86, P = 0.79). No significant difference was observed in the risk of either the primary or secondary endpoint between LBBAP and BVP after multivariate Cox regression (HR 0.74, 95% CI 0.45-1.23, P = 0.24, and HR 0.77, 95% CI 0.36-1.67, P = 0.51, respectively) or propensity score matching (HR 0.72, 95% CI 0.41-1.29, P = 0.28, and HR 0.69, 95% CI 0.29-1.65, P = 0.40, respectively). LBBAP was associated with a comparable effect on morbidity and mortality relative to BVP in patients with indications for CRT.

BackgroundAs the world’s population ages, hip replacement, a routine treatment for arthritis, has become more common. However, after surgery, rehabilitation has some limited effectiveness with postoperative complications and persistent impairments. This study aimed to explore the effect of a self-efficacy-enhancing intervention program following hip replacement on patients’ rehabilitation outcomes (self-efficacy, functional exercise compliance, hip function, activity and social participation, anxiety and depression, and quality of life).MethodsA prospective randomized controlled trial with a repeated-measures, two-group design was conducted in a grade A general hospital in Guangdong Province, China. A total of 150 participants with a unilateral total hip replacement were recruited via convenience sampling. Participants were randomly assigned to either the self-efficacy enhancing intervention group (n = 76) or the control group (n = 74). The intervention encompassed a face-to-face education before discharge and four telephone-based follow-ups in six months after surgery. Researchers collected baseline data on one to three days after surgery, and outcomes data were collected one, three, and six months after surgery.ResultsAverage age (deviation) in intervention and control group were 58 (10.32) and 59 (10.82), respectively. After six months, intervention group scored 86.83 ± 5.89 in rehabilitation self-efficacy, significantly higher than control group (72.16 ± 6.52, t = -10.820, p < 0.001) and their hip function has turned to “excellent” (90.52 ± 4.03), while that of the latter was limited to a “middle” level (78.47 ± 7.57). Statistically significant differences were found in secondary outcomes (p < 0.001). The advantage of intervention in improving quality of life was seen in the long term rather than in the early postoperative period.ConclusionsThe self-efficacy-enhancing intervention performed by nurses induced better exercise compliance and physical, psychological, and social functions after hip replacement compared with routine care. We recommend such interventions to be combined with routine care soon after hip replacement. Further research should focus on the social participation of patients with hip replacement.Trial registration Retrospectively registered at Chinese Clinical Trial Registry (31/01/2020, No. ChiCTR2000029422, http://www.chictr.org.cn/index.aspx).

The chemical characterization analysis of a medical device often results in chemical substances with unknown toxicities. While identification of each individual toxicity could result in a time-consuming hurdle with tremendous labor and financial burden, quantitative structure-activity relationship (QSAR) is of great significance for toxicity risk assessment of such chemical substances. By establishing quantitative relationship between the molecular structures or active groups of similar chemical compounds with their biological activities, QSAR can be utilized to predict the toxicity of such target compounds with significantly reduced cost and time. In this article, the authors generally summarized the mechanisms of QSAR approaches, current applications of QSAR modeling in the field of medical device, an introduction of the characteristics of publicly and commercially-available QSAR software, and briefly explored future trends of QSAR modeling in medical device toxicological risk assessment. The utilization of QSAR would undoubtedly further advance the toxicological risk assessment of medical devices.

Individualized lung-protective ventilation strategy is essential for patients with COVID-19. In this study, a wireless, low-power, and miniaturized electrical impedance tomography (EIT) system was developed for remote and long-term monitoring of lung ventilation for patients with COVID-19 in the isolation ward of ICU. A new strategy of combining filtering and improved voltage-controlled current was employed to design the current source for a simplified system structure, and a new differential receiver circuit consisting of a buffer amplification and a differential amplification was proposed to design the voltage measurement unit for high precision. Moreover, a Bluetooth interface was adopted for wireless data transmission, and components characterized by low power consumption were selected to minimize the system power consumption. The proposed EIT system occupies a total size of <inline-formula xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink"> <tex-math notation="LaTeX">$6.5\times 4.5\times0.6$ </tex-math></inline-formula> cm <sup xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">3</sup> and can work stably within 25 m from the wireless terminal installed with host EIT software. The system has a signal-to-noise of 70 dB at 50 kHz, stability of 0.1% relative change, and power consumption of 114 mW, as tested with a resistor phantom. Furthermore, a comparison between the proposed system and a commercial ICU EIT device was conducted on nine healthy volunteers for ventilation monitoring. The correlation between lung volume and relative impedance changes was higher than 0.9 for both EIT systems ( <inline-formula xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink"> <tex-math notation="LaTeX">$p &lt; 0.001$ </tex-math></inline-formula> ). The analysis of the corresponding EIT images revealed that both systems delivered comparable images in terms of linearity, repeatability, and regional ventilation distribution. The test and experimental results suggested that the proposed system could conveniently provide reliable data acquisition (DAQ) for remote and long-term lung ventilation monitoring.

Background: We have compared the patient characteristics and safety and efficacy results of the Micra transcatheter pacemaker from the China Micra Transcatheter Pacing Study with those from the global trials. Subjects and Methods: In this prospective, multicenter, single-arm study, patients with a class I or II guideline recommendation for single-chamber pacemaker therapy were enrolled from seven centers in China between July 30, 2018, and December 12, 2018. The primary outcome measure of this study was freedom from system- or procedure-related major complications through 6 months postimplantation (prespecified performance goal 83%). Patient baseline characteristics and major complications were compared with data from the global trials. Performance after medically indicated magnetic resonance imaging (MRI) scans was characterized. The study was approved by the ethics committee at each participating center and registered with ClinicalTrials.gov (Identifier: NCT03624504). Results: Implantation was successful in 81 of 82 (98.8%) patients with a mean follow-up of 8.7 ± 1.5 months. Chinese patients who had lower body mass index were more often female, and less frequently had a pacing indication associated with atrial fibrillation (AF) compared with global patients. Through 6 months postimplantation, two major complications occurred, with a major complication-free rate of 97.6% (95% confidence interval: 90.6–99.4%), exceeding the primary endpoint performance goal (P = 0.002). The major complication rate was in line with rates from the Micra investigational trial and Post-Approval Registry (2.4% vs. 3.7% and 2.9%, respectively, P = 0.50). Among 14 patients who underwent 3T MRI scans, electrical performance was stable with mean pre- and post-MRI pacing thresholds of &lt;0.5 V. No MRI-related device performance issues were observed. Conclusion: In the hands of new operators in China, the Micra pacemaker was implanted successfully with a very low complication rate. Although Chinese Micra patients were on average of smaller stature and the majority had a pacing indication not associated with AF, Micra performance was excellent and in line with the global trial experience.

Guideline recommendations for the prehospital and early in-hospital (first 6-12 hrs after presentation) management of acute heart failure syndromes are lacking. The American College of Cardiology/American Heart Association and European Society of Cardiology guidelines direct the management of these acute heart failure patients, but specific consensus on early management has not been published, primarily because few early management trials have been conducted. This article summarizes practical recommendations for the prehospital and early management of patients with acute heart failure syndromes; the recommendations were developed from a meeting of experts in cardiology, emergency medicine, and intensive care medicine from Europe and the United States. The recommendations are based on a unique clinical classification system considering the initial systolic blood pressure and other symptoms: 1) dyspnea and/or congestion with systolic blood pressure >140 mm Hg; 2) dyspnea and/or congestion with systolic blood pressure 100-140 mm Hg; 3) dyspnea and/or congestion with systolic blood pressure <100 mm Hg; 4) dyspnea and/or congestion with signs of acute coronary syndrome; and 5) isolated right ventricular failure. These practical recommendations are not intended to replace existing guidelines. Rather, they are meant to serve as a tool to facilitate guideline implementation where data are available and to provide suggested treatment approaches where formal guidelines and definitive evidence are lacking.