Expert review of medical devices最新文献

Introduction: In 2020, the sutureless Perceval PLUS aortic valve was introduced, featuring a new anticalcification treatment (FREE) and a shorter inflow ring in the XL size. We aimed to evaluate its early outcomes compared to earlier Perceval S design.

Methods: We retrospectively analyzed 1136 patients who received the Perceval bioprosthesis between 2007 and 2022, including 222 implanted with the Perceval PLUS. Patients implanted with the Perceval S were divided into two groups (S-OLD and S-NEW) depending on the sizing strategy. Survival, hemodynamic performance, and pacemaker implantation rates were assessed.

Results: The cohort had a mean age of 77 years and a EuroSCORE II of 6.3%. The observed 30-day mortality was similar across groups (3.7%, p = .326). Perceval PLUS demonstrated significantly improved hemodynamics, with lower peak (20.44 ± 8.95 mmHg) and mean gradients (11.44 ± 5.12 mmHg) compared to the S design (p < .001). A permanent pacemaker implantation (PPI) rate of 5.3% was achieved in minimally invasive aortic valve replacement in the PLUS group.

Conclusion: Early results from the Perceval PLUS show a secure profile with maintained benefits from the Perceval platform. The Perceval PLUS shows improved hemodynamics in comparison with the Perceval S and achieves low PPI rate.

Introduction: Device-based treatment of patients with resistant hypertension has become an important adjunct to medical therapy, although its place in clinical practice has not yet been fully established. The present minireview discusses the current state of affairs of such treatment modalities. We searched the literature in PubMed and MEDLINE for all relevant papers.

Areas covered: Most information is available for renal denervation, baroreceptor activation therapy and endovascular baroreflex amplification. Of these, most data have been obtained in randomized trials of renal denervation. Other treatments that are still under investigation are carotid body ablation, cardiac neuromodulation, deep brain stimulation and vagal nerve stimulation. Although all these techniques have originally been developed for hypertension, they are used more and more in heart failure.

Expert opinion: Currently, renal denervation is the only technique that may turn into a meaningful clinical treatment. It is effective, has a acceptable safety profile and is relatively easy to implement. Yet, more information is needed regarding long-term safety and effects on hard cardiovascular endpoints such as myocardial infarction and heart failure. All other forms of device-based treatment are not yet sufficiently developed.

Background: Women with a history of gestational diabetes mellitus (GDM) face an elevated risk of developing diabetes, yet postpartum screening is often This study evaluated the diagnostic utility of a blinded continuous glucose monitoring (CGM) system (Dexcom G7) for assessing glycemic status.

Methods: Of 40 enrolled participants, 39 completed testing at 6-24 weeks postpartum. Assessments included hemoglobin A1c (HbA1c,), fructosamine, a 75-g oral glucose tolerance test (OGTT), and 8-9 days of CGM wear. CGM metrics analyzed were mean glucose and time in range (TIR; 3.9-7.8 mmol/L).

Results: Diabetes and prediabetes were identified in 1 and 9 participants by HbA1c, 3 and 10 by fructosamine, and 4 and 10 by OGTT. CGM metrics detected 4 cases of diabetes and 10 of prediabetes. Mean OGTT glucose correlated strongly with mean CGM glucose (r = 0.66, p < 0.001) and inversely with TIR (r = -0.57, p < 0.001). Paired OGTT and CGM values were highly correlated (r = 0.874; p < 0.001).

Conclusion: Postpartum dysglycemia is prevalent after GDM. HbA1c and fructosamine lacked sensitivity and specificity, while CGM performed comparably to OGTT in detecting abnormal glucose metabolism in this postpartum population.Clinical trial registration: www.clinicaltrials.gov identifier is NCT06057805.

Introduction: Aortic stenosis is one of the most common valvular diseases, especially in the elderly. Transcatheter aortic valve replacement (TAVR) has become a mainstay treatment of severe, symptomatic aortic stenosis. Echocardiography remains the critical diagnostic tool for procedural success, complications, and follow-up.

Areas covered: In this review, we discuss the use of echocardiography for the assessment of transcatheter aortic valve (TAV) function. We summarize currently available data on expected mean gradients and effective orifice area in various valve types and sizes and how it may differ from invasive measurements. We also summarize the complexities of quantifying paravalvular TAV regurgitation and its impact on clinical outcomes.

Expert opinion: The hemodynamics of a transcatheter aortic valve is highly dependent on the inflow fluid dynamics. Although high gradients are undesirable, it does not necessary correlate to worse outcomes and should be taken into account with other parameters for assessment of valve function. Accurate diagnosis of bioprosthetic valve degeneration and failure is crucial as the TAVR patient shifts to younger and less co-morbid population.

Introduction: Retinal laser therapy has played a key role in managing numerous retinal vascular diseases, such as diabetic retinopathy, retinal vein occlusion, macular edema, and central serous chorioretinopathy since the 1960s. While conventional laser approaches are shown to be effective, they have been associated with permanent tissue scarring and vision loss. Recent advancements aim to minimize this collateral damage, using subdamaging or selective energy delivery to preserve healthy retina while balancing treatment benefit.

Areas covered: This review summarizes novel minimally traumatic retinal laser therapies, including micropulse lasers, selective retina therapy, nanosecond lasers, and other advanced laser and delivery systems. Although supporting clinical studies remains relatively small and longer follow-up is needed for clinical standardization, early results are promising, pointing toward safer and more effective retinal laser treatments options. A literature search of PubMed/MEDLINE and Embase was conducted for studies published up to July 2025.

Expert opinion: Minimally traumatic retinal lasers offer a promising adjunctive or alternative treatment for pharmacologic treatments with vision-preserving outcomes with reduced procedural burden. As ongoing research continues to validate safety and efficacy, these therapies will continue to play a critical role in the dynamic field of retinal disease management.

Background & objectives: Cementless total knee arthroplasties (TKAs) with porous tantalum tibial components were developed to improve fixation and reduce implant failure rates in younger, active patients. However, mid-term outcomes remain uncertain. This retrospective study compared survival rates of cementless TKAs with porous tantalum posterior-stabilized (PS) modular tibial components to cemented PS components from the same implant system, using revision for aseptic loosening as the endpoint.

Materials and methods: From January 2017 to November 2021, 899 TKAs were performed at a single tertiary center for osteoarthritis. Of these, 645 (71.7%) were cemented and 254 (28.3%) cementless. Median BMI was similar in both groups (30.0 kg/m² vs 31.0 kg/m²; p = 0.814). Cementless recipients were younger (median 66.0 vs. 72.0 years; p < 0.001). Follow-up continued through 31 December 2023.

Results: Seven-year survival was lower in the cementless group (97.1%, 95% CI 94.9-99.3) vs. cemented group (97.8%, 95% CI 96.6-99.0). Tibial component loosening led to 5 revisions in the cementless group vs. 2 revisions in the cemented group (p < 0.05). Two cementless cases involved tibial tray fractures. Overall, 86 patients (9.6%) died of unrelated causes.

Conclusions: Cementless porous tantalum TKAs had inferior mid-term performance for aseptic loosening, prompting their discontinuation at our institution.

Introduction: Acute type A aortic dissection (ATAAD) and aortic arch aneurysms are life-threatening conditions requiring complex surgical intervention, often involving circulatory arrest. Cerebral ischemia and neurological complications remain significant challenges in aortic arch surgery. This narrative review focuses on retrograde cerebral perfusion (RCP) techniques used to mitigate these risks.

Areas covered: This review article examines the evolution of cerebral protection strategies, with a focus on the techniques, parameters, and monitoring of RCP. It also compares RCP with antegrade cerebral perfusion (ACP) and deep hypothermic circulatory arrest (DHCA) regarding clinical outcomes.

Expert opinion: RCP has proven to be a valuable adjunct to DHCA in aortic arch surgery, offering comparable outcomes to ACP and demonstrating superiority over DHCA alone. Precise management of venous pressure and flow rate during RCP, along with meticulous cerebral monitoring, is crucial for optimizing neurological protection. Although ACP is increasingly favored in clinical practice, RCP continues to be a safe and effective cerebral protection strategy.

Introduction: Type 1 diabetes is a chronic disease requiring lifelong intensive insulin treatment. Automated insulin delivery (AID) systems such as Tandem Control-IQ allow for automatic adjustment of insulin delivery and can help improve glycemic outcomes.

Areas covered: This review will cover Tandem Control IQ AID technology and the Tandem t:slim X2 and Tandem Mobi insulin pumps including their physical features and function, the algorithm guiding insulin delivery, research regarding their safety and efficacy, and a brief overview of other AID systems. References were identified using PubMed.

Expert opinion: AID is now being considered as the standard for management of type 1 diabetes. Tandem Control IQ technology is one of several systems currently available that allows the user to benefit from the latest diabetes technology. Optimizing use of this system can lead to improved glycemic outcomes and decreased burden of disease for people with diabetes compared to multiple daily injections or open-loop insulin pump therapy.