Compatibility assessment of a temperature-controlled radiofrequency catheter with a novel electroanatomical mapping system

BackgroundThe novel DiamondTemp ablation system (DTA) and EnSiteX mapping System (EAM) are both CE-Marked and FDA approved medical devices. The DTA has been validated by its manufacturer only in combination with previous version of EnSite System—EnSite Precision. The aim of this study was to evaluate compatibility of DTA with EnSite X with a previously developed protocol.MethodsThree configurations were tested: 3.1. Medtronic Generator connection Box (GCB) and AmpereConnect cable; 3.2. the Medtronic GCB-E and electrogram out cable from GCB to EAM; 3.3. Direct connection of DTA to EAM using intracardiac out cable with no GCB.ResultsThe previously developed universal method for compatibility assessment of ablation catheters and navigation systems was used with success for assessing DTA and EnSite X EAM compatibility, with reproducible results. Accuracy of DTA visualization with different setups was evaluated with a phantom model measuring distances between DTA and reference points. DTA is compatible with EnSiteX EAM with a safety and reliability profile guaranteed, if within the described specifications. In particular, careful setup is mandatory to achieve good clinical outcomes as only setup 3.2 is viable for both NavX and Voxel Mode and demonstrated satisfactory results and accuracy. Setup 3.3 showed a significant shift immediately after catheter insertion. Catheter position was away from baseline points and the dislocation increased during the radiofrequency delivery.ConclusionsPreviously developed method for compatibility assessment of ablation catheters and navigation systems has been used for a new EAM. DTA is compatible with EnSiteX EAM with proper configuration

Diagnosis of intestinal parasites in a rural community of Venezuela : Advantages and disadvantages of using microscopy or RT-PCR

A cross-sectional study was carried out to determine the prevalence and diagnostic performance of microscopy and real time PCR (RT-PCR) for 14 intestinal parasites in a Venezuelan rural community with a long history of persistent intestinal parasitic infections despite the implementation of regular anthelminthic treatments. A total of 228 participants were included in this study. A multiplex RT-PCR was used for the detection of Dientamoeba fragilis, Giardia intestinalis, Cryptosporidium sp. and a monoplex RT-PCR for Entamoeba histolytica. Furthermore, a multiplex PCR was performed for detection of Ascaris lumbricoides, Strongyloides stercoralis, Necator americanus and Ancylostoma duodenale. Combined microscopy-PCR revealed prevalences of 49.3% for A. lumbricoides, 10.1% for N. americanus (no A. duodenale was detected), 2.0% for S. stercoralis, 40.4% for D. fragilis, 35.1% for G. intestinalis, and 7.9% for E. histolytica/dispar. Significant increases in prevalence at PCR vs. microscopy were found for A. lumbricoides, G. intestinalis and D. fragilis. Other parasites detected by microscopy alone were Trichuris trichiura (25.7%), Enterobius vermicularis (3.4%), Blastocystis sp. (65.8%), and the non-pathogenic Entamoeba coli (28.9%), Entamoeba hartmanni (12.3%), Endolimax nana (19.7%) and Iodamoeba bütschlii (7.5%). Age- but no gender-related differences in prevalences were found for A. lumbricoides, T. trichiura, G. intestinalis, and E. histolytica/dispar. The persistently high prevalences of intestinal helminths are probably related to the high faecal pollution as also evidenced by the high prevalences of non-pathogenic intestinal protozoans. These results highlight the importance of using sensitive diagnostic techniques in combination with microscopy to better estimate the prevalence of intestinal parasites, especially in the case of D. fragilis trophozoites, which deteriorate very rapidly and would be missed by microscopy. In addition, the differentiation between the pathogenic E. histolytica and the non-pathogenic E. dispar can be attained. However, microscopy remains an important diagnostic tool since it can detect other intestinal parasites for which no PCR is available

Diagnosis of intestinal parasites in a rural community of Venezuela : Advantages and disadvantages of using microscopy or RT-PCR

A cross-sectional study was carried out to determine the prevalence and diagnostic performance of microscopy and real time PCR (RT-PCR) for 14 intestinal parasites in a Venezuelan rural community with a long history of persistent intestinal parasitic infections despite the implementation of regular anthelminthic treatments. A total of 228 participants were included in this study. A multiplex RT-PCR was used for the detection of Dientamoeba fragilis, Giardia intestinalis, Cryptosporidium sp. and a monoplex RT-PCR for Entamoeba histolytica. Furthermore, a multiplex PCR was performed for detection of Ascaris lumbricoides, Strongyloides stercoralis, Necator americanus and Ancylostoma duodenale. Combined microscopy-PCR revealed prevalences of 49.3% for A. lumbricoides, 10.1% for N. americanus (no A. duodenale was detected), 2.0% for S. stercoralis, 40.4% for D. fragilis, 35.1% for G. intestinalis, and 7.9% for E. histolytica/dispar. Significant increases in prevalence at PCR vs. microscopy were found for A. lumbricoides, G. intestinalis and D. fragilis. Other parasites detected by microscopy alone were Trichuris trichiura (25.7%), Enterobius vermicularis (3.4%), Blastocystis sp. (65.8%), and the non-pathogenic Entamoeba coli (28.9%), Entamoeba hartmanni (12.3%), Endolimax nana (19.7%) and Iodamoeba bütschlii (7.5%). Age- but no gender-related differences in prevalences were found for A. lumbricoides, T. trichiura, G. intestinalis, and E. histolytica/dispar. The persistently high prevalences of intestinal helminths are probably related to the high faecal pollution as also evidenced by the high prevalences of non-pathogenic intestinal protozoans. These results highlight the importance of using sensitive diagnostic techniques in combination with microscopy to better estimate the prevalence of intestinal parasites, especially in the case of D. fragilis trophozoites, which deteriorate very rapidly and would be missed by microscopy. In addition, the differentiation between the pathogenic E. histolytica and the non-pathogenic E. dispar can be attained. However, microscopy remains an important diagnostic tool since it can detect other intestinal parasites for which no PCR is available

Table2_Compatibility assessment of a temperature-controlled radiofrequency catheter with a novel electroanatomical mapping system.docx

BackgroundThe novel DiamondTemp ablation system (DTA) and EnSiteX mapping System (EAM) are both CE-Marked and FDA approved medical devices. The DTA has been validated by its manufacturer only in combination with previous version of EnSite System—EnSite Precision. The aim of this study was to evaluate compatibility of DTA with EnSite X with a previously developed protocol.MethodsThree configurations were tested: 3.1. Medtronic Generator connection Box (GCB) and AmpereConnect cable; 3.2. the Medtronic GCB-E and electrogram out cable from GCB to EAM; 3.3. Direct connection of DTA to EAM using intracardiac out cable with no GCB.ResultsThe previously developed universal method for compatibility assessment of ablation catheters and navigation systems was used with success for assessing DTA and EnSite X EAM compatibility, with reproducible results. Accuracy of DTA visualization with different setups was evaluated with a phantom model measuring distances between DTA and reference points. DTA is compatible with EnSiteX EAM with a safety and reliability profile guaranteed, if within the described specifications. In particular, careful setup is mandatory to achieve good clinical outcomes as only setup 3.2 is viable for both NavX and Voxel Mode and demonstrated satisfactory results and accuracy. Setup 3.3 showed a significant shift immediately after catheter insertion. Catheter position was away from baseline points and the dislocation increased during the radiofrequency delivery.ConclusionsPreviously developed method for compatibility assessment of ablation catheters and navigation systems has been used for a new EAM. DTA is compatible with EnSiteX EAM with proper configuration.</p

Temperature analysis of 3D-printed biomaterials during unipolar and bipolar radiofrequency ablation procedure.

Due to their mechanical properties, the MED625FLX and TPU95A could be appropriate candidates for cardiac 3D surgical guide use during radiofrequency ablation (RFA) treatment.info:eu-repo/semantics/publishe

3D-Printed Biomaterial Testing in Response to Cryoablation: Implications for Surgical Ventricular Tachycardia Ablation

Background: The lack of thermally and mechanically performant biomaterials represents the major limit for 3D-printed surgical guides, aimed at facilitating complex surgery and ablations. Methods: Cryosurgery is a treatment for cardiac arrhythmias. It consists of obtaining cryolesions, by freezing the target tissue, resulting in selective and irreversible damage. MED625FLX and TPU95A are two biocompatible materials for surgical guides; however, there are no data on their response to cryoenergy delivery. The study purpose is to evaluate the biomaterials&rsquo; thermal properties, examining the temperature changes on the porcine muscle samples (PMS) when the biomaterials are in place during the cryoablation. Two biomaterials were selected, MED625FLX and TPU95A, with two thicknesses (1.0 and 2.5 mm). To analyze the biomaterials&rsquo; behavior, the PMS temperatures were measured during cryoablation, firstly without biomaterials (control) and after with the biomaterials in place. To verify the biomaterials&rsquo; suitability, the temperatures under the biomaterial samples should not exceed a limit of &minus;30.0 &deg;C. Furthermore, the biomaterials&rsquo; geometry after cryoablation was evaluated using the grid paper test. Results: TPU95A (1.0 and 2.5 mm) successfully passed all tests, making this material suitable for cryoablation treatment. MED625FLX of 1.0 mm did not retain its shape, losing its function according to the grid paper test. Further, MED625FLX of 2.5 mm is also suitable for use with a cryoenergy source. Conclusions: TPU95A (1.0 and 2.5 mm) and MED625FLX of 2.5 mm could be used in the design of surgical guides for cryoablation treatment, because of their mechanical, geometrical, and thermal properties. The positive results from the thermal tests on these materials and their thickness prompt further clinical investigation

Development of a 3D printed surgical guide for Brugada syndrome substrate ablation.

Brugada syndrome (BrS) is a disease associated with ventricular arrhythmias and sudden cardiac death. Epicardial ablation has demonstrated high therapeutic efficacy in preventing ventricular arrhythmias. The purpose of this research is to define a workflow to create a patient-specific 3D-printed tool to be used as a surgical guide for epicardial ablation in BrS.info:eu-repo/semantics/publishe

Evaluation of photogrammetry for medical application in cardiology.

Background: In the field of medicine, photogrammetry has played for long time a marginal role due to the significant amount of work required that made it impractical for an extended medical use. Developments in digital photogrammetry occurred in the recent years, that have steadily increased the interest and application of this technique. The present study aims to compare photogrammetry reconstruction of heart with computed tomography (CT) as a reference. Methods: The photogrammetric reconstructions of digital images from ECG imaging derived images were performed. In particular, the ventricles of 15 patients with Brugada syndrome were reconstructed by using the free Zephyr Lite software. In order to evaluate the accuracy of the technique, measurements on the reconstructions were compared to patient-specific CT scan imported in ECG imaging software UZBCIT. Result: The results showed that digital photogrammetry in the context of ventricle reconstruction is feasible. The photogrammetric derived measurements of ventricles were not statistically different from CT scan measurements. Furthermore, the analysis showed high correlation of photogrammetry reconstructions with CT scan and a correlation coefficient close to 1. Conclusion: It is possible to reproduce digital objects by photogrammetry if the process described in this study is performed. The reconstruction of the ventricles from CT scan was very close to the values of the respective photogrammetric reconstruction.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

3D Printed Surgical Guide for Coronary Artery Bypass Graft: Workflow from Computed Tomography to Prototype

Patient-specific three-dimensional (3D) printed models have been increasingly used in many medical fields, including cardiac surgery for which they are used as planning and communication tools. To locate and plan the correct region of interest for the bypass placement during coronary artery bypass graft (CABG) surgery, cardiac surgeons can pre-operatively rely on different medical images. This article aims to present a workflow for the production of a patient-specific 3D-printed surgical guide, from data acquisition and image segmentation to final prototyping. The aim of this surgical guide is to help visualize the region of interest for bypass placement during the operation, through the use of dedicated surgical holes. The results showed the feasibility of this surgical guide in terms of design and fitting to the phantom. Further studies are needed to assess material biocompatibility and technical properties.info:eu-repo/semantics/publishe

3D-Printed Biomaterial Testing in Response to Cryoablation: Implications for Surgical Ventricular Tachycardia Ablation.

Background: The lack of thermally and mechanically performant biomaterials represents the major limit for 3D-printed surgical guides, aimed at facilitating complex surgery and ablations. Methods: Cryosurgery is a treatment for cardiac arrhythmias. It consists of obtaining cryolesions, by freezing the target tissue, resulting in selective and irreversible damage. MED625FLX and TPU95A are two biocompatible materials for surgical guides; however, there are no data on their response to cryoenergy delivery. The study purpose is to evaluate the biomaterials' thermal properties, examining the temperature changes on the porcine muscle samples (PMS) when the biomaterials are in place during the cryoablation. Two biomaterials were selected, MED625FLX and TPU95A, with two thicknesses (1.0 and 2.5 mm). To analyze the biomaterials' behavior, the PMS temperatures were measured during cryoablation, firstly without biomaterials (control) and after with the biomaterials in place. To verify the biomaterials' suitability, the temperatures under the biomaterial samples should not exceed a limit of -30.0 °C. Furthermore, the biomaterials' geometry after cryoablation was evaluated using the grid paper test. Results: TPU95A (1.0 and 2.5 mm) successfully passed all tests, making this material suitable for cryoablation treatment. MED625FLX of 1.0 mm did not retain its shape, losing its function according to the grid paper test. Further, MED625FLX of 2.5 mm is also suitable for use with a cryoenergy source. Conclusions: TPU95A (1.0 and 2.5 mm) and MED625FLX of 2.5 mm could be used in the design of surgical guides for cryoablation treatment, because of their mechanical, geometrical, and thermal properties. The positive results from the thermal tests on these materials and their thickness prompt further clinical investigation.SCOPUS: ar.jinfo:eu-repo/semantics/publishe