Cardiac, Vascular and Transplant Surgery Quality Assessment. Intraoperative Ultrasound Imaging and TTFM

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1 Cardiac, Vascular and Transplant Surgery Quality Assessment Intraoperative Ultrasound Imaging and TTFM

2 Reduce risk of early graft failure, stroke, myocardial infarction or recurrent angina and provide the highest quality of life for your patients. VeriQ C combines ultrasound imaging and proven transit time flow measurement (TTFM) in a single system that is specifically designed for cardiovascular procedures. TTFM provides accurate and systematic assessments of graft patency. Imaging technology improves the quality assessment obtained from TTFM alone. Both techniques are better at finding plaque than your fingers. Traditional finger palpation has been demonstrated to be inadequate and even potentially harmful. Combining high-resolution imaging and blood flow measurement together in a single package is the new paradigm for intraoperative quality assessment and improved outcomes. CABG Epiaortic imaging allows a sensitive, direct diagnosis of aortic disease, which can lead to modifications in intraoperative surgical management. Epicardial imaging can be used intraoperatively to assess coronary quality, strategize graft placement and visualize constructed anastomosis. Vascular VeriQ C can assist with vascular reconstruction, from assessment and anastomosis discovery to verification and quality assurance in procedures such as carotid endarterectomy, femoropopliteal bypass surgery, or flow measurements of AV fistulae. Transplant Intraoperative assessment of organ transplants is often determined by verifying anastomosis quality and adequate graft perfusion, which can be easily documented using flow and imaging techniques improving outcomes and avoiding costly reinterventions. Probes to fit a wide range of surgical applications Medistim s flow probes are based on reliable TTFM. Together with the VeriQ C system, they provide fast, accurate and reproducible measurements of blood volume flow intraoperatively. The ultimate benefit is quality assurance with improved surgical outcome. Medistim s imaging probe used with the VeriQ C system provides high-resolution images to improve intraoperative assessment. Imaging technology is particularly relevant to verifying graft patency in a range of surgical applications: cardiac, vascular and transplants. TTFM Sizes for vessels mm in diameter Compliant with worldwide sterilization standards Available with and without handle for various surgical applications Imaging Approved for direct contact with cardiac tissue 128-element, high frequency probe for superior resolution images Specifically designed for cardiovascular procedures Sterilizable no need for sterile sheath

3 The VeriQ C system gives surgeons ultimate control, enabling planning, navigation and verification of cardiovascular procedures. TTFM Reliable flow volume measurement Obtain instant insight into the dynamics of graft function, and determine patency for intraoperative quality assurance, using proven TTFM in real time. The established numeric indices Pulsatility Index (PI), Diastolic Filling (DF%) and Mean Flow, the basis of our 3-parameter assessment method, provide an accurate insight into the dynamics of graft function. Revision Real-time data Blood flow in well-functioning coronary bypass grafts is mostly Diastolic Filling. DF indicates the percentage of bloodflow during diastole. The average or mean flow should not be used on its own to interpret graft patency. The flow can be low due to poor distal territory, low heart rate or low arterial pressure. Figure.A While more flow is generally better than less, a PI<5 and DF >50% indicates a technically patent graft. :12 AM 5s In the LIMA-LAD measurements presented in figure A, the pre-revision shows an occluded graft (PI 23.3, DF 49%, and Flow -1 ml/min). Following graft revision (Fig.B), the quality assessment measurement documents a much improved graft flow (PI 2.0, DF 73%, and Flow 18 ml/min). Figure.B

4 Planning Plan your procedure by scanning the Aorta prior to clamping and cannulation to ensure the aortic wall is free of soft or calcified plaque which have the potential to cause neurological damage. Courtesy of Dr. M. Kamler, University Hospital, Essen Navigation Identify and evaluate target vessels, including intramural coronaries and their position to adjacent structures, e.g. vein, muscle, fat, RV cavity. Navigate the vessels and assess coronary quality, morphology and the extent and locale of stenosis to facilitate optimal graft placement. Courtesy of Prof. R. Haaverstad, Haukeland University Hospital, Bergen Verification Verify your work by searching for possible sources of a compromised blood flow, including anastomosis quality, especially if TTFM readings indicate a functional graft issue. Check conduit for potential occlusion and investigate perfusion into the distal vascular bed. Courtesy of Prof. R. Haaverstad, Haukeland University Hospital, Bergen

5 Documentation Analysis and reporting The VeriQ C will store accurate flow analysis and produces a single documented report. This can be used as evidence of graft patency, as records for referring physicians and for preparing publications. Data Transfer Access and Sharing DICOM capability offers a flexible connectivity solution for transfer of imaging data to a centralized storage. Customization Workflow efficiency The VeriQ C can be customized and adapted to local preferences. Workflows can be streamlined to specific needs and languages.

6 Medistim VeriQ C System System features Flow & Pressure channels 19 touch screen Onboard color printer 500GB patient archive USB output No calibration required 4 Flow channels 2 Pressure channels 2 AUX channels Part number VQ4122C Imaging modes 2D B Mode CFM Color Flow Mapping PW Pulsed Wave Doppler VQ4122C Medistim Ultrasound Imaging probe Probe name Probe size Part number Sterilization methods Medistim L15 Ultrasound Imaging probe One size EL STERRAD Medistim TTFM probes - PS, PQ & PV probe series - available with and without handle Probe name Probe sizes Part numbers Sterilization methods Medistim QuickFit TTFM Probes 1.5mm, 2mm, 3mm, 4mm, 5mm, 7mm PS PS STERRAD Ethylene Oxide gas (EtO) Steam autoclave Medistim QuickFit TTFM Probes 1.5mm, 2mm, 3mm, 4mm, 5mm PQ PQ STERRAD Ethylene Oxide gas (EtO) Medistim Vascular TTFM Probes 6mm, 8mm, 10mm, 12mm, 14mm, 16mm PV PV STERRAD Ethylene Oxide gas (EtO) Steam autoclave Guidelines for Flow and Imaging 1. Transit Time Flow Measurement (TTFM) should be used to verify graft patency, as recommended by guidelines issued jointly in 2014 by the European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on myocardial revascularization. European Heart Journal (2014) doi: /eurheartj/ehu278b. 2. Epiaortic imaging guidelines published in 2007 by the American Society of Echocardiography and the Society of Cardiovascular Anesthesiologists have been endorsed by the Society of Thoracic Surgeons. Glas et al. Guidelines for the performance of a comprehensive intra-operative epiaortic ultrasonographic examination: recommendations of the American Society of Echocardiography and the Society of Cardiovascular Anesthesiologists; endorsed by the Society of Thoracic Surgeons. J Am Soc Echocardiogr Nov;20(11): Medistim s VeriQ system recommended by NICE for routine clinical use (Nov 2011): The National Institute for Health and Clinical Excellence (NICE) has accepted the health economics derived from routine usage of the VeriQ system for assessing graft blood flow during coronary artery bypass graft (CABG) surgery, compared to clinical assessment alone. NICE reports an estimated cost saving of more than 115 per patient. NICE also support the clinical evidence, suggesting reduction of early graft failure, stroke, myocardial infarction or recurrent angina. Medical technologies guidance MTG8. Issued November BR00IN004, ver 4, 11/14 Please refer to the User Manual for indications, contraindications, warnings, precautions, and further specifications and descriptions. Specifications may be changed without notice. For a list of flow probes for other applications, contact your Medistim representative. STERRAD is a registered trademark of the company ASP. FDA 510(k) cleared no. K FDA 510(k) cleared no. K medistim@medistim.com Medistim ASA (Head office) Økernveien Oslo Norway Phone Medistim Norge AS Økernveien Oslo Norway Phone Medistim Danmark ApS Gøngetoften Vedbæk Denmark Phone Medistim USA Inc th Ave N. Ste. 108 Plymouth, MN USA Phone Medistim Deutschland GmbH Bahnhofstr Deisenhofen Germany Phone +49 (0) Medistim UK Limited 34 Nottingham South Ind Est Ruddington Lane Wilford NOTTINGHAM NG11 7EP Phone +44 (0)