Device Delivery Research Articles

Impact of Home Care Services on Patient and Economic Outcomes: A Targeted Review

Patient Support Programs (PSPs) reinforce patients’ care provided by health care professionals with the aim to improve adherence and patient empowerment. PSPs may include interventions such as home-based care, individualized medication counseling, support, training, and home delivery of medicines and/or devices. This study described these services and its impact on patient-reported outcomes and health care savings. We conducted an integrative literature review which was limited to publications from the last 10 years (2009-2019) and focused on diseases that require special support and/or parenteral administration. From 7040 total citations, we identified 64 home-based care services performed worldwide. Among the home-based care services, most were provided by nurses (n = 47/64; 73.4%) and addressed to cancer patients (n = 22/64; 34.4%); 23 out of 64 services (35.9%) incorporated telepharmacy. In general, home-based services and PSPs showed a positive impact on patients’ adherence to medication, patient satisfaction, and health-related quality of life. In addition, 14 (21.9%) services reported economic results, most of which showed that home therapy led to substantial cost savings.

Self-expandable metallic stent placement for malignant biliary stricture using a novel device delivery system.

Video 1Self-expandable metallic stent placement for malignant biliary strictures using a novel device delivery system.

Assessment of Spatial Location and Air Transport Patterns of Minnesota’s Medical Device Industry Cluster

Minnesota’s medical device industry cluster is not only one of the biggest driving economic forces in the state, but also a global leader in the development and distribution of medical devices. The study assessed the medical device industry’s spatial development and air transport implications, both in terms of industry cluster location and flow of products. The spatial analysis showed that most medical device companies are located within the seven-county Twin-Cities region, but that industries linked to the medical device industry cluster are much more dispersed throughout the state. Regarding products created, the supply chain of medical devices is highly dependent on Minneapolis-St Paul Airport (MSP), which plays a key role in their delivery of medical devices. Air Cargo analysis reveals the high value of medical devices. exports to various locations and raises issues about the future role of air cargo through MSP to the economic prosperity of the industry cluster.

Application of a rabbit-elastase aneurysm model for preliminary histology assessment of the PPODA-QT liquid embolic.

Background: PPODA-QT is a novel liquid embolic under development for the treatment of cerebral aneurysms. We sought to test the rabbit-elastase aneurysm model to evaluate the tissue response following PPODA-QT embolization.Methods: Experimental elastase-induced aneurysms were created in fourteen New Zealand White Rabbits. Eight animals were used for aneurysm model and endovascular embolization technique development. Six PPODA-QT-treated animals were enrolled in the study. Control and aneurysm tissues were harvested at acute (n = 2), 1-month (n = 2), and 3-month (n = 2) timepoints and the tissues were prepared for histology assessment.Results: All fourteen rabbit-elastase aneurysms resulted in small and medium aneurysm heights (<10 mm dome height) with highly variable neck morphologies, small midline dome diameters, and beyond-wide dome-to-neck (d: n) ratios. Histological evaluation of four aneurysms, treated with PPODA-QT, demonstrated reorganization of aneurysm wall elastin into a smooth muscle layer, and observed as early as the 1-month survival timepoint. At the aneurysm neck, a homogenous neointimal layer (200–300 μm) formed at the PPODA-QT interface, sealing off the parent vessel from the aneurysm dome. No adverse immune response was evident at 1- and 3-month survival timepoints.Conclusion: PPODA-QT successfully embolized the treated aneurysms. Following PPODA-QT embolization, neointimal tissue growth and remodeling were noted with minimal immunological response. The experimental aneurysms created in rabbits were uniformly small with inconsistent neck morphology. Further testing of PPODA-QT will be conducted in larger aneurysm models for device delivery optimization and aneurysm healing assessment before human clinical investigation.

Mapping biopsy for bile duct cancer using a novel device delivery system.

Mapping biopsy for bile duct cancer using a novel device delivery system.

Assessment of mechanical and biocompatible performance of ultra-large nitinol endovascular devices fabricated via a low-energy laser joining process.

Nitinol is an excellent candidate material for developing various self-expanding endovascular devices due to its unique properties such as superelasticity, biocompatibility and shape memory effect. A low-energy laser joining technique suggests a high potential to create various large diameter Nitinol endovascular devices that contain complex geometries. The primary purpose of the study is to investigate the effects of laser joining process parameters with regard to the mechanical and biocompatible performance of Nitinol stents. Both the chemical composition and the microstructure of the laser-welded joints were evaluated using scanning electron microscopy (SEM) and energy-dispersive X-ray spectroscopy (EDS). In vitro study results on cytotoxicity demonstrated that the joining condition of 8 Hz frequency and 1 kW laser power showed the highest degree of endothelial cell viability after thermal annealing in 500°C for 30 min. Also, in vitro study results showed the highest oxygen content at 0.9 kW laser power, 8 Hz frequency, and 0.3 mm spot size after the thermal annealing. Mechanical performance test results showed that the optimal condition for the highest disconnecting force was found at 1 Hz frequency and 1 kW power with 0.6 mm spot size. Two new endovascular devices have been fabricated using the optimized laser joining parameters, which have demonstrated successful device delivery and retrieval, as well as acute biocompatibility.

Lateral Axillary Exposure for Antegrade Access during Endovascular Repair of Complex Abdominal Aortic and Thoracoabdominal Aneurysms

Retrospective, single-center review between 2006 and 2018. Fifty-three patients were treated with 260 parallel renovisceral stents or stent grafts to treat pararenal and thoracoabdominal aortic aneurysms using a lateral axillary artery exposure. The axillary artery was exposed using a vertical skin incision in the axilla with retraction of the lateral border of the pectoralis major distal to the pectoralis minor to expose the axillary artery and then directly accessed with multiple sheaths (5F-12F). There were two local complications (hematoma managed conservatively and brachial vein thrombosis managed with anticoagulation). Left axillary exposure is a valid approach for upper extremity access during endovascular repair of complex aortic aneurysms requiring simultaneous delivery of multiple renovisceral devices.

Practical Utility of the Postal Service in Delivering a Self-Fitted, Wearable, Long-Term Electrocardiogram Monitoring Device for Outpatient Care.

Background: Demand is growing for remote electrocardiogram (ECG) monitoring systems in the COVID-19 era in Japan. This study describes initial experiences with a small wireless ECG monitoring device and the utility of delivery via the postal service for outpatient care in Japan.Methods and Results: Long-term ECG monitoring following postal delivery of the small ECG device was evaluated in 25 patients. The patients had no difficulties with either the postal delivery or self-fitting and wearing the devices. A median of 57 h monitoring per patient was performed. Arrhythmic events were detected in 8 patients. Most patients were satisfied with both the ECG devices and postal delivery.Conclusions: Postal delivery of ECG devices could be used in clinical practice to achieve less or no in-person contact during the COVID-19 era.

Calcium Modification Techniques in Complex Percutaneous Coronary Intervention.

Percutaneous coronary intervention is the most common mode of revascularization and is increasingly undertaken in high-risk subsets, including the elderly. The presence of coronary artery calcification is increasingly observed and significantly limits technical success. The mechanisms for this are multi-factorial, including increased arterial wall stiffness and impaired delivery of devices, leading to suboptimal stent delivery, deployment, and expansion which are harbingers for increased risk of in-stent restenosis and stent thrombosis. Although conventional balloon pretreatment techniques aim to mitigate this risk by modifying the lesion before stent placement, many lesions remain resistant to conventional strategies, due to the severity of calcification. There have been several substantial technological advancements in calcium modification methods in recent years, which have allowed improved procedural success with low periprocedural complication rates. This review will summarize the current adjunctive modification technologies that can be employed to improve technical outcomes in percutaneous coronary intervention in calcific disease and the evidence supporting these tools.

Aerosol drug delivery to tracheotomized patients with COVID-19: Pragmatic suggestions for clinicians.

Because of the wide and rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the number of hospitalized patients with coronavirus disease 2019 (COVID-19) has rapidly increased medically complex and resource-intensive treatment requirements in health care settings. Although tracheostomy is frequently needed for critically ill patients requiring extended mechanical ventilation, it has been described as an aerosol-generating procedure that puts health care professionals at an increased risk of viral transmission. In addition, the delivery of aerosolized medications to this patient population has become controversial because of concerns on the transmission of SARS-CoV-2 via droplets. Although aerosol therapy in spontaneously breathing patients with COVID-19 was described in recent publications, innovations in aerosol drug delivery to COVID-19 patients with tracheostomy have not been presented. Therefore, empirically based guidance on how to deliver aerosols safely and effectively to tracheotomized patients with COVID-19 is still lacking. This paper provides recommendations and rationales for device selection, interface selection, delivery techniques, and infection control based on the evolving body of literature.

Walrus large bore guide catheter impact on recanalization first pass effect and outcomes: the WICkED study

BackgroundThe use of a balloon-guide catheter (BGC) in acute stroke treatment has been widely adopted after demonstrating optimized procedure metrics and outcomes. Initial technical constraints of previous devices included catheter...

Teleassistance for Patients With Type 1 Diabetes During the COVID-19 Pandemic: Results of a Pilot Study.

BackgroundTelemedicine use in chronic disease management has markedly increased during health emergencies due to COVID-19. Diabetes and technologies supporting diabetes care, including glucose monitoring devices, software analyzing glucose data, and insulin delivering systems, would facilitate remote and structured disease management. Indeed, most of the currently available technologies to store and transfer web-based data to be shared with health care providers.ObjectiveDuring the COVID-19 pandemic, we provided our patients the opportunity to manage their diabetes remotely by implementing technology. Therefore, this study aimed to evaluate the effectiveness of 2 virtual visits on glycemic control parameters among patients with type 1 diabetes (T1D) during the lockdown period.MethodsThis prospective observational study included T1D patients who completed 2 virtual visits during the lockdown period. The glucose outcomes that reflected the benefits of the virtual consultation were time in range (TIR), time above range, time below range, mean daily glucose, glucose management indicator (GMI), and glycemic variability. This metric was generated using specific computer programs that automatically upload data from the devices used to monitor blood or interstitial glucose levels. If needed, we changed the ongoing treatment at the first virtual visit.ResultsAmong 209 eligible patients with T1D, 166 completed 2 virtual visits, 35 failed to download glucose data, and 8 declined the visit. Among the patients not included in the study, we observed a significantly lower proportion of continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII) users (n=7/43, 16% vs n=155/166, 93.4% and n=9/43, 21% vs n=128/166, 77.1%, respectively; P<.001) compared to patients who completed the study. TIR significantly increased from the first (62%, SD 18%) to the second (65%, SD 16%) virtual visit (P=.02); this increase was more marked among patients using the traditional meter (n=11; baseline TIR=55%, SD 17% and follow-up TIR=66%, SD 13%; P=.01) than among those using CGM, and in those with a baseline GMI of ≥7.5% (n=46; baseline TIR=45%, SD 15% and follow-up TIR=53%, SD 18%; P<.001) than in those with a GMI of <7.5% (n=120; baseline TIR=68%, SD 15% and follow-up TIR=69%, SD 15%; P=.98). The only variable independently associated with TIR was the change of ongoing therapy. The unstandardized beta coefficient (B) and 95% CI were 5 (95% CI 0.7-8.0) (P=.02). The type of glucose monitoring device and insulin delivery systems did not influence glucometric parameters.ConclusionsThese findings indicate that the structured virtual visits help maintain and improve glycemic control in situations where in-person visits are not feasible.

Procedural Effectiveness With a Focused Force Scoring Angioplasty Catheter: Procedural and Clinical Outcomes From the Scoreflex NC Trial

BackgroundThe Scoreflex NC scoring angioplasty catheter is designed with a short rapid-exchange tip distal to a non-compliant, high-pressure balloon and an integral wire outside of the balloon, such that the guidewire and the integral wire act as scoring elements during balloon inflation. The external scoring elements enable a focal stress pattern facilitating expansion of resistant lesions at lower pressures using a focused force angioplasty effect. MethodsPatients undergoing elective percutaneous coronary intervention (PCI) were enrolled in a prospective, single-arm study conducted at 12 centers in the United States. The primary endpoint was device procedural success, defined as the composite of successful device delivery to the target lesion with balloon inflation and deflation; absence of vessel perforation, flow-limiting dissection or reduction in TIMI flow from baseline; and achievement of final TIMI 3 flow. ResultsAmong 200 patients (234 lesions), lesion complexities included: bifurcation disease (37.6%), moderate/severe calcification (36.6%), and total occlusions (5.0%). Successful delivery to the target lesion, inflation and removal of the balloon catheter was achieved in 95.5% of patients (191/200). Procedural success was achieved in 93.5% (187/200) of patients, and final TIMI 3 flow was observed in 99.0% of cases (198/200). No unanticipated device-related events occurred. In-hospital major adverse events were reported in 4.5% of patients (9/200), related to periprocedural myocardial infarction (8/200, 4.0%) and target lesion revascularization (1/200, 0.5%). ConclusionsAmong patients undergoing elective PCI and with varied lesion complexity, these results support the safety and effectiveness of a dilation strategy using the Scoreflex NC scoring catheter.

State of the Art Care in Computer-Assisted Facial Prosthetic Rehabilitation.

Autologous reconstruction for major facial defects is primarily considered for patient's lifetime care. There are situations, however, when autologous reconstruction is not ideal or feasible, and prosthetic reconstruction is necessary to reconstruct missing anatomy or to complement surgical reconstruction. The history of facial prosthetic reconstruction can be traced for millennia. At our craniofacial center, craniomaxillofacial prosthetic rehabilitation has been incorporated in the care provided to our patients since the center's inception, more than 70 years ago.The purpose of this review is to present the evolution of our current thinking based on our long experience since the implementation of computer-assistive technologies over 15 years ago, to further improve our patients' overall rehabilitation.These applications include all stages of prosthetic care from planning, design through device delivery, and for lifetime maintenance. The collaboration among surgeons and anaplastologists is fundamental to achieving optimal patient outcomes and in the success of our technology-based practice. Such collaboration starts with the patient's decision to proceed with prosthetic rehabilitation and continues with postoperative care and lifetime management of the patient's prosthetic device and prosthesis-bearing soft tissue.Although computer-assistive techniques often represent a substantial financial investment, the benefits of using them demonstrate clear advantages to both the clinician and patient. These benefits include: Improved predictability of outcomes, surgeon preparedness, reduction in operating room time, reduction in overall treatment times, improved precision and anatomical accuracy, improved treatment efficiencies, and overall treatment experience, particularly for those patients traveling great distances for access to care.Representative examples will be presented.

Lateral Axillary Exposure for Antegrade Access during Endovascular Repair of Complex Abdominal Aortic and Thoracoabdominal Aneurysms

During endovascular treatment of pararenal aortic aneurysms (PAA) and thoracoabdominal aortic aneurysms (TAAA), our antegrade vascular access of choice is a lateral axillary exposure (LAE). We directly access the axillary artery with multiple sheaths followed by primary closure of the axillary artery at case completion. The aim of this study is to describe our technique and to report our results with this approach. This study is a single-institution, retrospective review of 53 patients who were treated with parallel grafts for endovascular repair of PAA and TAAA from 2006 to 2018. The aortic repairs requiring LAE included: 9 cases of endo-leaks from prior endovascular repair, 20 TAAAs, and 24 PAAs. The axillary artery was exposed with a vertical axillary skin incision followed by retraction of the lateral border of the pectoralis major to expose the axillary artery distal to the pectoralis minor. A 5-French (F) through 12F sheaths were used to directly access the axillary artery for delivery of endovascular devices. Two hundred and sixty reno-visceral stents were delivered through 125 axillary sheaths in an antegrade fashion to 114 arteries without intraoperative complications or technical failures. Two postoperative complications included an access-site hematoma managed conservatively (1.9%) and a left brachial vein thrombosis treated with anticoagulation (1.9%). There were no cases of cerebrovascular or peripheral neurologic events, upper extremity ischemia, or reoperation related to LAE. LAE is a valid approach for upper extremity access during the endovascular repair of complex aortic aneurysms requiring simultaneous delivery of multiple reno-visceral devices. It does not require the use of a prosthetic conduit. There were no neurologic events or upper extremity ischemia in our series.

Management of arch aneurysms with a single-branch thoracic endograft in zone 0.

BackgroundWe present preliminary data from a patient cohort undergoing thoracic endovascular aortic repair for Ishimaru zone 0 and 1 using a novel branched arch endograft.MethodsThis US multicenter early feasibility investigational device exemption clinical trial treated 9 patients with a mean age 72.8 ± 8.0 years (77.8% male). The endograft was designed with a single side branch designed to facilitate aortic coverage proximal to the innominate or left carotid artery while maintaining branch vessel patency. Pathology treated included fusiform (n = 2) or saccular (n = 7) aneurysm, with a maximum aortic diameter of 6.3 ± 0.7 cm. Treatment was into zone 0 in 8 patients, and zone 1 in 1 patient.ResultsAll patients underwent initial successful first-stage supra-aortic trunk revascularization using a variety of techniques, without the occurrence of stroke. For the second thoracic endovascular aortic repair stage, median total treatment length was 20 cm. The primary end point of device delivery and branch vessel patency was achieved in 100% of patients, without 30-day mortality or spinal cord ischemia. Cerebrovascular events were observed in 2 patients through 30 days. No type I or III endoleaks were reported and all side branches were patent at 12-month imaging follow-up.ConclusionsEndovascular repair of Ishimaru zone 0 or 1 arch aortic aneurysms can be achieved with a novel branched arch endograft. Future studies will evaluate the mid-term outcomes with this device in other pathologies and further define the occurrence of postoperative neurologic events.

A review of South African Public Healthcare policies addressing Service Delivery for wheelchairs through a Primary Health Care lens

ABSTRACT INTRODUCTION: In some areas of South Africa, people with impaired mobility are known to have difficulty accessing wheelchairs. This study aimed to critically appraise public healthcare policies addressing service delivery in terms of assistive devices in general, and more specifically wheelchairs within primary health care METHOD: South African public healthcare policies that address assistive device service delivery were identified and thematically analysed using retrospective deductive document analysis. The themes used correspond to the WHO guidelines for the provision of wheelchairs within the context of the guiding principles of primary health care i.e., accessibly, affordability, acceptability, appropriateness, and availability. An analysis was undertaken on how the provision of assistive devices under these principles was addressed RESULTS: Three policies were identified addressing assistive device service delivery i.e. The National Rehabilitation Policy, The Policy Framework and Strategy for Disability and Rehabilitation Services in South Africa 2015 - 2020, and the National Health Insurance Policy. The National Rehabilitation Policy addressed the majority of the WHO guiding principles on wheelchair provision. Guidelines for non-discriminatory and evidence-based service delivery and the availability of assistive devices were identified in all the documents. Scant attention was paid to service delivery of assistive devices for people residing in urban or peri-urban areas. There was a paucity of guidance on service delivery to people with impaired mobility who were unable to access health services, those unaware of the services available and those who were not aware of the benefits of an assistive device CONCLUSION: The policies, viewed together, addressed all the WHO guiding principles, although some gaps were observed in each policy. A proposal emanating from this review was that an update of the National Rehabilitation Policy would address these deficiencies Keywords: assistive devices, health policy, impaired mobility, disability, rehabilitation

Advancing the Sustainable Use of Ethylene Oxide through Process Validation.

Based on excellent material compatibility and ability for scale, ethylene oxide (EO) sterilization constitutes approximately 50% of single-use medical device sterilization globally. Epidemiological considerations have elevated focus toward optimization of EO processes, whereby only necessary amounts of sterilant are used in routine processing. EO sterilization of medical devices is validated in accordance with AAMI/ANSI/ISO 11135:2014 via a manner in which a sterility assurance level (SAL) of 10-6 is typically achieved, with multiple layers of conservativeness delivered, using "overkill" approaches to validation. Various optimization strategies are being used throughout the medical device industry to deliver the required SAL while utilizing only necessary amounts of sterilant. This article presents relevant experiences and describes challenges and considerations encountered in delivering EO process optimization. Thus far, the results observed by the authors are encouraging in demonstrating how EO processing can be optimized in the delivery of critical single-use medical devices for patient care.

A Method to Evaluate Vessel Deviation during Withdrawal of a Stent Retriever Using a Silicon Vascular Model.

Catastrophic complications may develop because of vessel deviation during device delivery into intracranial vessels for neurointerventions. We report a novel method using a silicon model capable of evaluating vessel deviation as a numerical value. In all, 10 tiny markers, each with a pitch of approximately 5 mm, were attached to the vessel model along the long axis. We used a high-resolution camera to record movies of the deviation of the vessel model while employing different stent retrievers. The movies were reviewed to determine the maximum deviation of each marker on the vessel model. As expected, stent retrievers of the same type exhibited more vessel shifts when they had a larger diameter and longer length. On the other hand, stents with a segmental structure demonstrated less vessel deviation than those with a tubular structure, regardless of the large lumen and long length. If the degree of vessel stress can be represented by a numerical value, areas where the careful use of different devices for neurointerventions is required may be able to be identified. Moreover, this method may be useful for training.

Three-dimensional virtual and printed models for planning adult cardiovascular surgery

Background The objective of this study was to explore the usefulness of virtual models and three-dimensional (3D) printing technologies for planning complex non-congenital cardiovascular surgery. Methods Between July 2018 and December 2019, adult patients with different cardiovascular structural diseases were included in a clinical protocol to explore the usefulness of Standard Tessellation Language (STL)-based virtual models and 3D printing for prospectively planning surgery. A qualitative descriptive analysis from the surgeon’s viewpoint was done based on the characteristics, advantages and usefulness of 3D models for guiding, planning and simulating the surgical procedures. Results A total of 14 custom 3D-printed heart and great vessel replicas with their corresponding 3D virtual models were created for preoperative surgical planning. Six of 14 models helped to redefine the surgical approach, 3 were useful to verify device delivery, while the rest did not change the surgical decision. In all open surgery cases, cardiac and vascular anatomy accuracy of virtual and physical 3D replicas was validated by direct visualisation of the organs during surgery. Printing was achieved through an external provider associated with the Hospital, who printed the final prototype in 5–7 days. Printed production cost was between 100 and 500 USD per model. Conclusions In the current study, the selected 3D printed models presented different advantages (visual, tactile, and instrumental) over the traditional flat anatomical images when simulating and planning some complex types of surgery. Notwithstanding 3D printing advantages, STL-based virtual models were pre-printing useful tools when instrumentation on a physical replica was not required.