Expert review of medical devices最新文献

Introduction: Transcatheter aortic valve replacement (TAVR) has transformed treatment of severe aortic stenosis, offering a less invasive alternative to surgery. Despite advances, stroke remains a serious complication, impacting morbidity, mortality, and long-term cognitive function, thus the need for effective prevention strategies.

Areas covered: Based on a targeted review of the PubMed literature, this review addresses mechanisms and risk factors for stroke after TAVR and evaluates current preventive approaches. Cerebral embolic protection devices (CEPDs), particularly the Sentinel system, are discussed alongside other devices. Antithrombotic strategies before, during, and after TAVR are also reviewed, emphasizing the balance between thromboembolic protection and bleeding risk in an elderly population.

Expert opinion: While some studies suggest CEPDs may reduce stroke, randomized trials have not confirmed broad and robust benefit, and high cost limits routine adoption. Future work should focus on high-risk subgroups, device refinement, and large-scale trials. For now, individualized antithrombotic therapy and selective CEPD use remain central to stroke prevention in TAVR.

Introduction: Temporary mechanical circulatory support (tMCS) has become essential in managing severe cardiac dysfunction, particularly refractory cardiogenic shock (CS). Despite widespread adoption, the optimal use of tMCS is often guided by institutional experience rather than robust evidence, leaving questions about device selection and patient outcomes.

Areas covered: We conducted a structured literature review of studies published in major databases (PubMed), using keywords such as intra-aortic balloon pump, veno-arterial extracorporeal membrane oxygenation, percutaneous ventricular assist devices, cardiogenic shock, and related terms. Key clinical scenarios reviewed include acute myocardial infarction-related CS, post-cardiotomy shock, and support for high-risk percutaneous coronary interventions. We critically examine randomized controlled trials, extensive observational studies, and consensus statements published in the last five years.

Expert opinion: While tMCS has revolutionized the management of CS, its optimal use is still limited by a lack of high-quality evidence, ongoing device-related complications, and economic challenges. Future advancements in device technology, patient stratification, and standardized protocols, alongside continued research and innovation, are essential to improve outcomes and broaden the accessibility.

Background: Tricuspid regurgitation (TR) adversely impacts mortality and hospitalizations. Transvenous pacemaker and defibrillator leads are associated with worsening TR, underscoring the need for lead designs that minimize adverse tricuspid valve interference.

Method: We developed a physics-based computational model to evaluate the general effect of lead diameter and material stiffness on the regurgitant orifice area (ROA). Additionally, we simulated three commercial transvenous leads, with diameters of 4.7 Fr, 6.8 Fr and 8.6 Fr, and evaluated the induced ROA. Three pre-implant baseline conditions were considered in all cases: no TR, mild TR and moderate TR.

Results: Lead diameter exhibited a predominant effect on ROA compared to material properties. In mild and moderate TR baselines, thicker leads resulted in exponential increases in ROA. The 4.7 Fr lead remained significantly below clinically relevant increases in TR. In contrast, the 6.8 Fr and 8.6 Fr leads induced a transition from mild to moderate TR.

Conclusions: Simulations support the mechanistic expectation that thinner defibrillation leads reduce mechanical interference with tricuspid leaflet coaptation, with potential implications on clinical outcomes.

Introduction: The SynCardia Total Artificial Heart (TAH) offers a life-saving mechanical circulatory support (MCS) option for patients with end-stage biventricular (BiV) heart failure who are not candidates for traditional devices or are awaiting transplantation. The device and its prior success has opened doors to further research in newer devices and technologies to combat existing challenges with TAH.

Areas covered: This review highlights the clinical utility, device profile and function, safety considerations, patient selection, and current challenges associated with the device. It summarizes key clinical studies, FDA approval history, technical specifications of the TAH, outcomes, complications, and logistical considerations. Literature was sourced through PubMed and clinical trial databases using terms such as 'SynCardia,' 'total artificial heart,' 'biventricular failure,' and 'bridge to transplant.'

Expert opinion: TAH offers full heart replacement and is evolving toward becoming a long-term alternative to transplants. Challenges like power supply, long-term durability, and biocompatibility are being addressed through innovations such as fully implantable systems and hybrid biological-mechanical designs. Unlike transplantation, TAHs avoid immunosuppression and offer hope to patients who cannot wait for donor hearts.In the coming years, global development of advanced TAHs, coupled with better clinical acceptance could transform treatment of end-stage heart failure providing a more accessible, reliable, and life-sustaining solution.

Background: Early Feasibility Studies (EFS) support early-stage evaluation of novel technologies. Under the European Union Medical Device Regulation (EU MDR 2017/745), National Competent Authorities (NCAs) assess these investigations. However, little is known about their organizational readiness and ability to assess complex technologies in a consistent and coordinated manner.

Research design and methods: A mixed-methods study was conducted via an online survey and virtual workshop involving 23 NCAs. Outcome measures included assessor assignment models, qualifications, training, use of external experts, sponsor dialogue mechanisms, and preparedness for emerging technologies. Data were thematically analyzed to assess systemic readiness and capacity.

Results: There is variability in the documentation of clinical investigation phases and assessment practices. Gaps in NCA resources were notable in digital health technology (DHTs) and artificial intelligence-enabled medical devices (AIeMD) and statistics. Dialogue mechanisms were present in 63% of NCAs and associated with improved submission quality. Training was fragmented and use of external experts limited. NCAs emphasized regulatory strain due to rising complexity.

Conclusions: There is significant variability in assessor qualifications and practices. These differences limit the consistency of regulatory oversight under the MDR. Establishing structured training programs, and harmonized sponsor dialogue mechanisms will be critical to supporting regulatory preparedness and coherence.

Introduction: Infective endocarditis (IE) is a serious and increasingly recognized condition, associated with significant morbidity and mortality. The diagnosis of IE is more challenging in patients with implanted cardiac devices such as cardiac implantable electronic devices, left ventricular assist devices, and left atrial appendage occlusion devices.

Areas covered: This review focuses on the contemporary roles and applications of multi-modality imaging in the evaluation of patients with cardiac implantable electronic devices related infection and IE. The role of multi-modality imaging in the diagnosis of patients with native or prosthetic valve IE is beyond the scope of this review. A literature search of the PubMed database was performed between 1 June 2024, and 30 June 2025. Relevant articles on the subjects of 'infective endocarditis,' 'multi-modality imaging,' and 'implanted cardiac devices' were utilized in our review.

Expert opinion: The growing utilization of cardiac implanted electronic devices (CIED) demands improvement in the detection of CIED-related infections. Contemporary guidelines have considered utilizing multimodality imaging to diagnose IE. The incremental value of multimodality imaging remains to be rigorously examined. Large observational studies from tertiary centers might serve as the starting point toward building a strong evidence base.

Introduction: Successful biliary cannulation is crucial for the efficacy of endoscopic retrograde cholangiopancreatography (ERCP). Failure to achieve cannulation can lead to procedure failure, highlighting the importance of mastering various cannulation techniques, particularly in challenging cases.

Areas covered: This article examines advanced biliary cannulation techniques, including guidewire-assisted methods, precut sphincterotomy, and rendezvous procedures. The literature search encompassed PubMed/MEDLINE, Embase, and the Cochrane Library from inception to April 2024, focusing on randomized trials, meta-analyses, and systematic reviews evaluating efficacy and safety.

Expert opinion: This paper advocates for a structured, algorithmic approach to cannulation, emphasizing early recognition of difficulty and strategic escalation to advanced techniques to enhance success rates and minimize complications like post-ERCP pancreatitis.

Background: This meta-analysis aimed to assess the efficacy and safety of cerebral embolic protection devices (CEPDs) in patients undergoing transcatheter aortic valve implantation (TAVI).

Methods: PubMed, Cochrane Central, and ScienceDirect were searched till April 2025. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled under a random-effects model using Review Manager. The Cochrane risk of bias (RoB 2.0) tool was used for quality assessment. Funnel plots were assessed for publication bias.

Results: Eight randomized controlled trials, including 11,632 patients undergoing TAVI, were analyzed. Use of CEPDs showed a non-significant reduction in all strokes (RR 0.92, 95% CI: 0.74-1.15, p = 0.48) and disabling stroke (RR 0.80, 95% CI: 0.57-1.12, p = 0.18). There was no significant difference in all-cause mortality (RR 1.09, 95% CI: 0.71-1.67, p = 0.70), acute kidney injury (AKI) (RR 0.96, 95% CI: 0.44-2.11, p = 0.93), disabling bleeding (RR 0.96, 95% CI: 0.28-3.31; p = 0.94) and major vascular complications (RR 1.25, 95% CI: 0.56-2.78, p = 0.59).

Conclusion: CEPD did not significantly reduce the incidence of ischemic lesions or neurocognitive decline. Current evidence does not support a statistically significant clinical benefit of CEPD use during TAVI. While trends suggest a potential reduction in stroke, larger trials are needed to establish the significance of these results.

Background: Interstitial lung disease (ILD) in diffuse cutaneous systemic sclerosis (dcSSc) often develops early but remains clinically silent, as dyspnea appears usually after substantial fibrosis. Reduced activity from musculoskeletal limitations further delays recognition. This study assessed alveolar-capillary permeability using 99mTc-DTPA aerosol scintigraphy in dcSSc patients and correlated clearance rates with high-resolution computed tomography (HRCT) and spirometry.

Methods: In this cross-sectional study at a tertiary center in South India (December 2018-January 2021), patients fulfilling ACR/EULAR 2013 dcSSc criteria underwent 99mTc-DTPA aerosol scintigraphy, HRCT, and spirometry.

Results: Among 61 participants, the mean DTPA clearance half-time (T½) was 48.11 ± 23.99 minutes. Patients with ILD had significantly faster clearance than those without ILD (44.06 ± 17.37 vs 63.03 ± 37.28 minutes, p = 0.01). T½ correlated negatively with Warrick's CT score (r = -0.310, p = 0.015) and positively with FVC (r = 0.287, p = 0.026). ROC analysis showed an AUC of 0.646 (95% CI 0.455-0.837); at a cutoff of 49.62 minutes, sensitivity was 68.6% and specificity 60%. The specificity increased to 80% and 90% for cutoffs of 36.83 and 35.48 minutes, respectively.

Conclusion: DTPA clearance was significantly faster in dcSSc patients with ILD. Aerosol scintigraphy may detect early alveolar-capillary dysfunction before radiologic or spirometric changes. Further studies incorporating DLCO and longitudinal follow-up are warranted.