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Journal of the American College of... Jul 2023Bioresorbable vascular scaffolds (BVS) were designed to improve late event-free survival compared with metallic drug-eluting stents. However, initial trials demonstrated... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Bioresorbable vascular scaffolds (BVS) were designed to improve late event-free survival compared with metallic drug-eluting stents. However, initial trials demonstrated worse early outcomes with BVS, in part due to suboptimal technique. In the large-scale, blinded ABSORB IV trial, polymeric everolimus-eluting BVS implanted with improved technique demonstrated noninferior 1-year outcomes compared with cobalt chromium everolimus-eluting stents (CoCr-EES).
OBJECTIVES
This study sought to evaluate the long-term outcomes from the ABSORB IV trial.
METHODS
We randomized 2,604 patients at 147 sites with stable or acute coronary syndromes to BVS with improved technique vs CoCr-EES. Patients, clinical assessors, and event adjudicators were blinded to randomization. Five-year follow-up was completed.
RESULTS
Target lesion failure at 5 years occurred in 216 (17.5%) patients assigned to BVS and 180 (14.5%) patients assigned to CoCr-EES (P = 0.03). Device thrombosis within 5 years occurred in 21 (1.7%) BVS and 13 (1.1%) CoCr-EES patients (P = 0.15). Event rates were slightly greater with BVS than CoCr-EES through 3-year follow-up and were similar between 3 and 5 years. Angina, also centrally adjudicated, recurred within 5 years in 659 patients (cumulative rate 53.0%) assigned to BVS and 674 (53.3%) patients assigned to CoCr-EES (P = 0.63).
CONCLUSIONS
In this large-scale, blinded randomized trial, despite the improved implantation technique, the absolute 5-year rate of target lesion failure was 3% greater after BVS compared with CoCr-EES. The risk period for increased events was limited to 3 years, the time point of complete scaffold bioresorption; event rates were similar thereafter. Angina recurrence after intervention was frequent during 5-year follow-up but was comparable with both devices.(Absorb IV Randomized Controlled Trial; NCT02173379).
Topics: Humans; Absorbable Implants; Coronary Artery Disease; Everolimus; Percutaneous Coronary Intervention; Prosthesis Design; Stents; Tissue Scaffolds; Treatment Outcome
PubMed: 37207924
DOI: 10.1016/j.jacc.2023.05.003 -
BMJ Open Jun 2024The development of paediatric medical devices continues to lag adult medical devices and contributes to issues of inequity, safety, quality and patient outcomes. New...
INTRODUCTION
The development of paediatric medical devices continues to lag adult medical devices and contributes to issues of inequity, safety, quality and patient outcomes. New legislation and funding mechanisms have been introduced over the past two decades, but the gap remains. Clinical trials have been identified as a pain point, but components of effective clinical research infrastructure are poorly understood. As part of a multimodal research strategy, the Pediatric Device Consortia (PDC) will conduct a scoping review to better understand infrastructural barriers to and facilitators of paediatric medical device clinical research identified in the health sciences literature.
METHODS AND ANALYSIS
The following databases will be included for this review: Medline, Embase, Cochrane CENTRAL, Web of Science and IEEE Xplore. Additional grey literature will be sought out through Google Scholar and reviewing the citations of included studies. Included studies will discuss medical devices according to the U.S. Food and Drug Administration classification, focus on the paediatric population (ages 0-21 years) and involve human premarket or postmarket research. All study types that were published in 2007-present in English, Spanish, French or Italian will be included. Using Covidence web-based software, two independent reviewers will screen the resulting titles, abstracts and the full text of potential studies. Conflicts will be resolved by the primary investigator during both phases. REDCap will be used for quantitative and qualitative data charting, generating data tables and narrative synthesis.
ETHICS AND DISSEMINATION
This research did not require research ethics board consideration as it does not involve human participants and all data will be collected from published literature. We will share our findings through peer-reviewed manuscripts, clinical and research conference presentations and professional networks available to the PDC.
STUDY REGISTRATION
Open Science Framework (https://osf.io/k72bn).
Topics: Humans; Child; Equipment and Supplies; Pediatrics; Research Design; Adolescent; Inventions; Review Literature as Topic
PubMed: 38839390
DOI: 10.1136/bmjopen-2023-081541 -
Medicina (Kaunas, Lithuania) Nov 2023Heart failure remains a major global burden regarding patients' morbidity and mortality and health system organization, logistics, and costs. Despite continual advances... (Review)
Review
Heart failure remains a major global burden regarding patients' morbidity and mortality and health system organization, logistics, and costs. Despite continual advances in pharmacological and resynchronization device therapy, it is currently well accepted that heart transplantation and mechanical circulatory support represent a cornerstone in the management of advanced forms of this disease, with the latter becoming an increasingly accepted treatment modality due to the ongoing shortage of available donor hearts in an ever-increasing pool of patients. Mechanical circulatory support strategies have seen tremendous advances in recent years, especially in terms of pump technology improvements, indication for use, surgical techniques for device implantation, exchange and explantation, and postoperative patient management, but not in the field of treatment of critically ill patients and those undergoing cardiac arrest. This contemporary review aims to summarize the collected knowledge of this topic with an emphasis on complications in patients with left ventricular assist devices, their treatment, and establishing a clear-cut algorithm and the latest recommendations regarding out-of-hospital or emergency department management of cardiac arrest in this patient population.
Topics: Humans; Heart Transplantation; Tissue Donors; Heart Failure; Cardiopulmonary Resuscitation; Heart-Assist Devices; Heart Arrest
PubMed: 38004030
DOI: 10.3390/medicina59111981 -
Alternative Therapies in Health and... Nov 2023When a medical device or surgical instrument comes into contact with the patient's sterile tissue or mucous membrane during the various processes, the risk of... (Review)
Review
When a medical device or surgical instrument comes into contact with the patient's sterile tissue or mucous membrane during the various processes, the risk of introducing infections into the patient's body increases. Furthermore, an infection may be transmitted from one patient to another, from a patient to a member of the medical staff and vice versa or from the environment to the patient via improperly sterilized or disinfected equipment. A number of outbreaks and diseases have been documented in the hospital setting as a result of poorly sanitized devices. As a result, adequate disinfection procedures for medical and surgical items are required in all healthcare facilities. It is equally the responsibility of healthcare providers to reduce and eliminate such infections. Each hospital should have its own standards for sterilization and disinfection of equipment based on the intended use of medical devices and associated infections. In order to reduce the risk of both endogenous and exogenous infections, infection control procedures must be implemented in general practice. Using a formulation containing alcohol alone or in combination with other agents to properly wash hands after each patient's checkup and before any procedure reduces the likelihood of transmitting infections to and from patients. Sterilization and disinfection are the most important aspects of infection control. The most common sterilization methods are steam sterilizers and ethylene dioxide sterilizers. Trash generated during practice should be handled according to protocol and rules, as it may be a source of nosocomial infections. Trained personnel are required to carry out these procedures.
Topics: Humans; Disinfection; Cross Infection; Surgical Instruments; Health Personnel; Treatment Outcome
PubMed: 37708558
DOI: No ID Found -
Advanced Materials (Deerfield Beach,... Sep 2023Flexible and stretchable bioelectronics provides a biocompatible interface between electronics and biological systems and has received tremendous attention for in situ... (Review)
Review
Flexible and stretchable bioelectronics provides a biocompatible interface between electronics and biological systems and has received tremendous attention for in situ monitoring of various biological systems. Considerable progress in organic electronics has made organic semiconductors, as well as other organic electronic materials, ideal candidates for developing wearable, implantable, and biocompatible electronic circuits due to their potential mechanical compliance and biocompatibility. Organic electrochemical transistors (OECTs), as an emerging class of organic electronic building blocks, exhibit significant advantages in biological sensing due to the ionic nature at the basis of the switching behavior, low driving voltage (<1 V), and high transconductance (in millisiemens range). During the past few years, significant progress in constructing flexible/stretchable OECTs (FSOECTs) for both biochemical and bioelectrical sensors has been reported. In this regard, to summarize major research accomplishments in this emerging field, this review first discusses structure and critical features of FSOECTs, including working principles, materials, and architectural engineering. Next, a wide spectrum of relevant physiological sensing applications, where FSOECTs are the key components, are summarized. Last, major challenges and opportunities for further advancing FSOECT physiological sensors are discussed.
Topics: Wearable Electronic Devices; Electronics; Semiconductors; Prostheses and Implants; Engineering; Transistors, Electronic
PubMed: 36808773
DOI: 10.1002/adma.202209906 -
Journal of Cardiothoracic Surgery Nov 2023Acute type A aortic dissection is associated with high perioperative morbidity and mortality. Ascyrus Medical Dissection Stent (Cryolife, Kennesaw, USA) is a novel...
BACKGROUND
Acute type A aortic dissection is associated with high perioperative morbidity and mortality. Ascyrus Medical Dissection Stent (Cryolife, Kennesaw, USA) is a novel uncovered hybrid stent graft developed to be used as an adjunct to standard surgical approach to promote true lumen expansion and enhance aortic remodeling.
METHODS
From March 2021 to March 2022, four consecutive patients presented with acute Debakey type I aortic dissection and underwent emergent surgical repair with Tirone David procedure and implantation of Ascyrus Medical Dissection Stent. We reviewed patient's files retrospectively and described the perioperative outcomes.
RESULTS
All four device implantations were successful. Overall 30-day mortality was 0%. Malperfusion that was present in two patients pre-operatively improved after Ascyrus Medical Dissection Stent implantation. No aortic reinterventions were needed. No aortic injury related to the device was noted. Favourable changes in aortic true lumen and false lumen dimensions were found in most of our patients but the stent was compressed at the isthmus in one patient.
CONCLUSION
Ascyrus Medical Dissection Stent is a reliable and secure device. However, its benefits remain unclear when it comes to a positive remodeling and seems less likelihood comparable to a frozen elephant trunk. The main reason seems to be an insufficient radial force of the stent.
Topics: Humans; Aorta, Thoracic; Aortic Aneurysm, Thoracic; Aortic Dissection; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Postoperative Complications; Retrospective Studies; Stents; Treatment Outcome
PubMed: 37993865
DOI: 10.1186/s13019-023-02377-0 -
Heart Rhythm Sep 2023Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing...
Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third-party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence-based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified.
Topics: Humans; Defibrillators, Implantable; Remote Sensing Technology
PubMed: 37211145
DOI: 10.1016/j.hrthm.2023.03.1525 -
JACC. Clinical Electrophysiology Aug 2023Device-related thrombus (DRT) after left atrial appendage closure (LAAC) procedures is a rare but potentially serious event. Thrombogenicity and delayed...
BACKGROUND
Device-related thrombus (DRT) after left atrial appendage closure (LAAC) procedures is a rare but potentially serious event. Thrombogenicity and delayed endothelialization play a role in the development of DRT. Fluorinated polymers are known to have thromboresistant properties that may favorably modulate the healing response to an LAAC device.
OBJECTIVES
The goal of this study was to compare the thrombogenicity and endothelial coverage (EC) after LAAC between the conventional uncoated WATCHMAN FLX (WM) and a novel fluoropolymer-coated WATCHMAN FLX (FP-WM).
METHODS
Canines were randomized for implantation with WM or FP-WM devices and given no postimplant antithrombotic/antiplatelet agents. The presence of DRT was monitored by using transesophageal echocardiography and verified histologically. The biochemical mechanisms associated with coating were assessed by using flow loop experiments to quantify albumin adsorption, platelet adhesion, and porcine implants to quantify EC and the expression of markers of endothelial maturation (ie, vascular endothelial-cadherin/p120-catenin).
RESULTS
Canines implanted with FP-WM exhibited significantly less DRT at 45 days than those implanted with WM (0% vs 50%; P < 0.05). In vitro experiments showed significantly greater albumin adsorption (52.8 [IQR: 41.0-58.3] mm vs 20.6 [IQR: 17.2-26.6] mm; P = 0.03) and significantly less platelet adhesion (44.7% [IQR: 27.2%-60.2%] vs 60.9% [IQR: 39.9%-70.1%]; P < 0.01) on FP-WM. Porcine implants showed significantly greater EC by scanning electron microscopy (87.7% [IQR: 83.4%-92.3%] vs 68.2% [IQR: 47.6%-72.8%]; P = 0.03), and higher vascular endothelial-cadherin/p120-catenin expression after 3 months on FP-WM compared with WM.
CONCLUSIONS
The FP-WM device showed significantly less thrombus and reduced inflammation in a challenging canine model. Mechanistic studies indicated that the fluoropolymer-coated device binds more albumin, leading to reduced platelet binding, less inflammation, and greater EC.
Topics: Animals; Dogs; Swine; Fluorocarbon Polymers; Prosthesis Design; Atrial Fibrillation; Atrial Appendage; Treatment Outcome; Thrombosis; Inflammation
PubMed: 37204356
DOI: 10.1016/j.jacep.2023.04.013 -
The Journal of Heart and Lung... Sep 2023Reduced arterial pulsatility in continuous-flow left ventricular assist devices (CF-LVAD) patients has been implicated in clinical complications. Consequently, recent...
BACKGROUND
Reduced arterial pulsatility in continuous-flow left ventricular assist devices (CF-LVAD) patients has been implicated in clinical complications. Consequently, recent improvements in clinical outcomes have been attributed to the "artificial pulse" technology inherent to the HeartMate3 (HM3) LVAD. However, the effect of the "artificial pulse" on arterial flow, transmission of pulsatility into the microcirculation and its association with LVAD pump parameters is not known.
METHODS
The local flow oscillation (pulsatility index, PI) of common carotid arteries (CCAs), middle cerebral arteries (MCAs) and central retinal arteries (CRAs-representing the microcirculation) were quantified by 2D-aligned, angle-corrected Doppler ultrasound in 148 participants: healthy controls, n = 32; heart failure (HF), n = 43; HeartMate II (HMII), n = 32; HM3, n = 41.
RESULTS
In HM3 patients, 2D-Doppler PI in beats with "artificial pulse" and beats with "continuous-flow" was similar to that of HMII patients across the macro- and microcirculation. Additionally, peak systolic velocity did not differ between HM3 and HMII patients. Transmission of PI into the microcirculation was higher in both HM3 (during the beats with "artificial pulse") and in HMII patients compared with HF patients. LVAD pump speed was inversely associated with microvascular PI in HMII and HM3 (HMII, r = 0.51, p < 0.0001; HM3 "continuous-flow," r = 0.32, p = 0.0009; HM3 "artificial pulse," r = 0.23, p = 0.007), while LVAD pump PI was only associated with microcirculatory PI in HMII patients.
CONCLUSIONS
The "artificial pulse" of the HM3 is detectable in the macro- and microcirculation but without creating a significant alteration in PI compared with HMII patients. Increased transmission of pulsatility and the association between pump speed and PI in the microcirculation indicate that the future clinical care of HM3 patients may involve individualized pump settings according to the microcirculatory PI in specific end-organs.
Topics: Humans; Microcirculation; Heart-Assist Devices; Heart Failure; Heart Rate; Middle Cerebral Artery
PubMed: 37098374
DOI: 10.1016/j.healun.2023.04.002 -
Proceedings of the Institution of... Nov 2023The increase in regulatory challenges on medical technology developed and deployed in the UK is having a negative impact on innovation. In this paper we show how the...
The increase in regulatory challenges on medical technology developed and deployed in the UK is having a negative impact on innovation. In this paper we show how the limited capacity of Approved and Notified Bodies is one more barrier in the innovation pipeline, that could push more teams to consider applying for FDA approval instead of UKCA marking, potentially limiting how much our patients benefit from the world-leading research undertaken in UK universities.
Topics: United Kingdom; Medical Device Legislation; Equipment and Supplies; Inventions
PubMed: 37840272
DOI: 10.1177/09544119231203776