Potential Access Route Research Articles

Integrated Care Models in Germany – potential Market Access route for Medical Devices?

Introduction: The 2004 introduced Integrated Care Models – ICM (§140 a Social Code Book), the German Managed Care, incrementally making share of the SHI healthcare expenditures. Recent research suggests integrated care models as a not yet spotted potential access route for medical devices and hence faster access to innovative diagnostics and treatment methods. However, the perception among stakeholders might be quite differential. The key question within the discussion is if the integrated care contracts could be an opportunity for market access which might overcome potential issues for market access through regular routes. Methods: Integrated Care Models have been evaluated systematically through a triangulated approach – the analysis of model concepts, the organizational and contractual set-ups and by semi-structured interviews with key stakeholders. Results: Most of the times integrated care contracts will only come into place when there might at least be a win-win situation between the industry and health insurance companies. The primary advantages are among others, the involvement of almost all decisive stakeholders of the healthcare system for market access and reimbursement. This eases demonstrably as well the successful application in regular approval routes across sectors. On the other hand, conflicting in this regard is the situation of the associations of statutory physicians which are not included by law as stakeholders for an integrated care models and only slowly discovering ways to participate. However, the budget control mechanisms on a regional level are major hurdles as by today and one part of the problem of discussion. Nevertheless, Integrated Care Models provide a potential market access route for medical devices through targeted product placement. ICM’s Medical Advisory boards have the freedom to include a product either under specific own managed budget lines in already existing contract or to include it by implementing new treatment procedures in the ICM. In addition, the systematic development of treatment procedures associated to the product leading to professional case management structures, potentially supporting guideline developments and overall show a reasonable fast access to these innovative medical devices. Conclusions: Even though there is a still halting progress of ICM and the therefore quite sparse overall knowledge among all stakeholders, integrated care obviously appears as a quite promising access route for medical devices by bridging the often lengthy and challenging procedures across sectors but primarily in outpatient care, were the current regular route is often still a deadlock.

Integrated Care Models In Germany – Potential Market Access Route For Medical Devices?

For the market access of innovative medical devices in Germany it plays a key role whether a medical device is applied in the inpatient or in the outpatient setting. There are several possible reimbursement pathways for innovative medical devices, among them Integrated Care Models – ICM (§140 a Social Code Book). Recent research suggests ICMs as a not yet spotted potential access route for medical devices and hence faster access to innovative diagnostics and treatment methods. However, the perception among stakeholders might be quite differential. The key question within the discussion is if the ICM contracts could be an opportunity for market access which might overcome potential issues for market access through regular routes. ICMs have been evaluated systematically through a triangulated approach – the analysis of model concepts, the organizational set-ups and by semi-structured interviews with key stakeholders. In 2011, 6339 contracts exist, covering 1,9 Million insured persons. The actual number of ICM contracts is probably higher. An obligation to notify was established 2012. In total 8120 contracts could be reported in 2015 to the Federal Insurance office (BVA). There are two options for a manufacturer (outpatient setting): First, inclusion of a product within existing ICMs or second, setting up a new ICM with potential stakeholders as partners. The systematic development of treatment procedures associated to the product leading to professional case management structures, potentially supporting guideline developments and overall show a reasonable fast access to these innovative medical devices. ICM contracts are a positive addition to the regular reimbursement possibilities for innovative medical products in cross-sectoral, interdisciplinary care. The extended context of selective contracts makes the implementation of supply innovations possible by bridging the often lengthy and challenging procedures across sectors but primarily in outpatient care, were the current regular route is often still a deadlock.

Exploring methods to minimize the risk of mosquitoes in rainwater harvesting systems

Rainwater harvesting in residential homes is emerging as an important complement to centralized water supplies in urban centres around the world. Domestic rainwater harvesting systems provide a variety of benefits for water management and contribute to sustainable and integrated urban water management. There are however risks associated with rainwater harvesting that requires appropriate mitigation. One such risk is that systems can become breeding grounds for mosquitoes. This can constitute a significant health risk through the spread of mosquito-borne diseases (i.e. arbovirus and malaria). This paper explores the extent to which mosquitoes breed in rainwater harvesting systems as well as the effectiveness of different risk mitigation actions. Data were sourced from a large-scale domestic rainwater tank inspection survey undertaken in Melbourne and were analysed using simple Bayesian Network models. The observed rate of mosquito breeding was too high and was identified as a serious concern for health officials and water managers. The most common access routes into the tank system were found to be through the tank inlet or overflow. By exploring different system set-ups it was found that in order to mitigate the risk of mosquito breeding in tanks, all potential access routes must be adequately sealed. The complete eradication of mosquitos in rainwater tanks, however, may need further investigation, as 4% of systems with adequate protection at the inlet and overflow were still found to have mosquitoes in them.

Fully Percutaneous Transthoracic Left Atrial Entry and Closure as a Potential Access Route for Transcatheter Mitral Valve Interventions

Percutaneous access for mitral interventions is currently limited to transapical and transseptal routes, both of which have shortcomings. We hypothesized that the left atrium could be accessed directly through the posterior chest wall under imaging guidance. We tested percutaneous transthoracic left atrial access in 12 animals (10 pigs and 2 sheep) under real-time magnetic resonance imaging or x-ray fluoroscopy plus C-arm computed tomographic guidance. The pleural space was insufflated with CO2 to displace the lung, an 18F sheath was delivered to the left atrium, and the left atrial port was closed using an off-the-shelf nitinol cardiac occluder. Animals were survived for a minimum of 7 days. The left atrial was accessed, and the port was closed successfully in 12/12 animals. There was no procedural mortality and only 1 hemodynamically insignificant pericardial effusion was observed at follow-up. We also successfully performed the procedure on 3 human cadavers. A simulated trajectory to the left atrium was present in all of 10 human cardiac computed tomographic angiograms analyzed. Percutaneous transthoracic left atrial access is feasible without instrumenting the left ventricular myocardium. In our experience, magnetic resonance imaging offers superb visualization of anatomic structures with the ability to monitor and address complications in real-time, although x-ray guidance seems feasible. Clinical translation seems realistic based on human cardiac computed tomographic analysis and cadaver testing. This technique could provide a direct nonsurgical access route for future transcatheter mitral implantation.

Natural orifice transluminal endoscopic surgery in surgical oncology: analysis of indications and feasibility in cancer patients.

Natural orifice endoscopic surgery (NOTES) is an emerging technique that has been postulated as a promising alternative to laparoscopy in the field of minimal invasive surgery. Until now appropriate indications, safe access routes and general feasibility of this approach have not been defined exactly in surgical oncology. A total of 474 patients undergoing cancer surgery were analyzed regarding possible applications of transluminal endoscopic surgery. Patient with potential indications underwent intraoperative endoscopy to evaluate technical aspects, indications and intraoperative feasibility. A potential indication for transluminal surgery was found in 54 of 474 patients (11%) undergoing abdominal cancer surgery. Staging of gastrointestinal tumors was considered the main indication (45%) followed by splenectomy (11%) and diagnostic excision (11%). As a potential access route the transgastric approach was considered in 42 patients (66%) and the transcolonic approach in 18 patients (28 %). Of these 42 patients, 19 (30%) presented with significant intra-abdominal adhesions which would have resulted in a more complicated procedure. Accurate transluminal orientation was considered impossible in 13 cases (20%). Although some indications for NOTES procedures in surgical oncology have been identified in this study these techniques have to be assessed cautiously. Implementation of NOTES in surgical oncology is currently difficult because of technical problems, lack of intraoperative orientation and abdominal adhesions.

Experimental Endoscopic Endovascular Cannulation: A Novel Approach to Thrombolysis in Retinal Vessel Occlusion

Recent studies suggest that the cannulation of retinal vessels may provide a potential access route for the administration of thrombolytic agents in retinal vessel occlusion. However, the major problem with available techniques is the limited visualization of retinal vessels with conventional surgical microscopes, making it difficult to effectively control the targeted injection of drugs. The authors developed a novel single-piece catheter system for the endoscopically guided puncture of microvessels. Experimental punctures of retinal vessels with injection of fluid were performed in porcine cadaver eyes using a standard high-resolution gradient index microendoscope introduced through the pars plana. Endoscopically guided punctures were successfully performed in porcine branch retinal veins at various distances from the optic disc. Injection of recombinant tissue plasminogen activator (rt-PA), hypertonic solution (hyper HES), or normal saline solution into the vessel lumen was accomplished under direct endoscopic view in a safe and reliable manner. Endoscopically guided puncture of retinal microvessels is feasible and can be performed through a pars plana entry without additional micromanipulation devices. This novel technique may be a safe and effective approach to catheter-directed endovascular thrombolysis in retinal vascular occlusive diseases.

Transgastric access techniques for NOTES

Natural orifice translumenal endoscopic surgery (NOTES) has been the focus of extensive research since the first NOTES procedure was reported in 2004 by Kalloo and colleagues. Although a number of animal experiments and some human experiences of NOTES have been reported in the last few years, there are many issues that need to be addressed before this technique is adopted widely in clinical practice. Achieving a safe and effective access to the peritoneal cavity at an optimal location using most favorable techniques was the foremost barrier. So far, transgastric, transrectal, transvaginal, and transurethral approaches have been reported as potential access routes to the peritoneal cavity, of which the transgastric route has been one of the most widely studied. Although the transgastric route has advantages over other routes for lower abdominal and peritoneal organs given the straight approach from upper abdomen, it has its limitations as a route for organs located in the upper peritoneum, where retroflexion is required and the maneuverability is limited. With the development of new technologies and new devices, the potential limitations of each access route are being addressed. Moreover, the natural orifice surgery consortium for assessment and research (NOSCAR®) white paper pointed out that the optimal access route would vary with the nature of the intended procedure. Larger studies and randomized controlled trials are needed for setting guidelines regarding the optimal access routes for NOTES procedures.

Complexes of Horseradish Peroxidase with Formate, Acetate, and Carbon Monoxide

Carbon monoxide, formate, and acetate interact with horseradish peroxidase (HRP) by binding to subsites within the active site. These ligands also bind to catalases, but their interactions are different in the two types of enzymes. Formate (notionally the "hydrated" form of carbon monoxide) is oxidized to carbon dioxide by compound I in catalase, while no such reaction is reported to occur in HRP, and the CO complex of ferrocatalase can only be obtained indirectly. Here we describe high-resolution crystal structures for HRP in its complexes with carbon monoxide and with formate, and compare these with the previously determined HRP-acetate structure [Berglund, G. I., et al. (2002) Nature 417, 463-468]. A multicrystal X-ray data collection strategy preserved the correct oxidation state of the iron during the experiments. Absorption spectra of the crystals and electron paramagnetic resonance data for the acetate and formate complexes in solution correlate electronic states with the structural results. Formate in ferric HRP and CO in ferrous HRP bind directly to the heme iron with iron-ligand distances of 2.3 and 1.8 A, respectively. CO does not bind to the ferric iron in the crystal. Acetate bound to ferric HRP stacks parallel with the heme plane with its carboxylate group 3.6 A from the heme iron, and without an intervening solvent molecule between the iron and acetate. The positions of the oxygen atoms in the bound ligands outline a potential access route for hydrogen peroxide to the iron. We propose that interactions in this channel ensure deprotonation of the proximal oxygen before binding to the heme iron.

Ultraschallbasierte, MRT-gesteuerte Thermoablation von Uterusmyomen - erste Erfahrungen mit einer neuen, nichtinvasiven Behandlungsmethode

Purpose: High frequency focused ultrasound (HIFUS) is a new completely noninvasive therapeutic modality for the treatment of uterine myomas. Feasibility and morbidity were analyzed within the constraints of a phase II study. Patients and Methods: 11 pre- and postmenopausal women with a significantly enlarged uterus due to myomas were treated with MR-guided high frequency focused ultrasound (HIFUS; Fa. Insightec, Israel) as part of an international multicenter study. The objective was to estimate the feasibility and morbidity of the new modality (phase II). The diagnosis as established by clinical and ultrasound examination was in a first step verified by MR, then the potential access route was determined and larger necroses were excluded. In a second session the myomas were treated under MR guidance with HIFUS on an outpatient basis. 3 - 5 days after therapy the perfusion defect of the treated tumor volume was determined by MR. Within 30 days of HIFUS-therapy all patients had their uterus excised and examined pathologically. Results: The treatment could be completed as planned in 9 of 11 patients (duration of treatment 2 - 4 hours). In general the treatment was tolerated well. Minor pain was experienced during and some exhaustion was felt after therapy. In 1 patient therapy was impossible due to suboptimal localization of the myoma. In an-other patient treatment was not initiated because of metallic artifacts in an abdominal wall scar. The resulting necrosis as seen in the path specimen had three times the size of the treated volume within the myoma. In no case was necrosis detected outside the myoma. Conclusions: Uterine myomas can be treated by HIFUS noninvasively, reliably and without significant morbidity. A phase III study is under way to verify the efficiency of the modality.

Mortality of Little Brown Bats Following Multiple Pesticide Applications

Mortality of Little Brown Bats Following Multiple Pesticide Applications