Intraoperative Ultrasound Imaging and TTFM

Cardiac, Vascular and Transplant Surgery Quality Assessment

STERRAD® is a registered trademark of the company ASP.

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.

CABGEpiaortic 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.

TransplantIntraoperative 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.

Reduce risk of early graft failure, stroke, myocardial infarction or recurrent angina – and provide the highest quality of life for your patients.

TTFM • Sizes for vessels 1.5-16 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

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.

The VeriQ C™ system gives surgeons ultimate control, enabling planning, navigation and verification of cardiovascular procedures.

TTFMReliable flow volume measure-ment

RevisionReal-time data

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.

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.

While more flow is generally better than less, a PI50% indicates a technically patent graft.

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).

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Patient Report

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Here is the very bad LIMA to lAD 

 

 

 

Figure.A

Figure.B

Planning

Navigation

Verification

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.

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.

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 Dr. M. Kamler, University Hospital, Essen

Courtesy of Prof. R. Haaverstad, Haukeland University Hospital, Bergen

Courtesy of Prof. R. Haaverstad, Haukeland University Hospital, Bergen

Data TransferAccess and Sharing

DocumentationAnalysis and reporting

CustomizationWorkflowefficiency

DICOM capability offers a flexible connectivity solution for transfer of imaging data to a centralized storage.

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.

The VeriQ C™ can be customized and adapted to local preferences. Workflows can be streamlined to specific needs and languages.

Medistim ASA (Head office)Økernveien 940579 Oslo NorwayPhone +47 23 05 96 60

Medistim Danmark ApSGøngetoften 132950 VedbækDenmarkPhone +45 2276 5669

Medistim USA Inc.14000 25th Ave N. Ste. 108Plymouth, MN 55447USAPhone +1 763 208 9852

Medistim Deutschland GmbHBahnhofstr. 3282041 DeisenhofenGermanyPhone +49 (0) 89 62 81 90 33

Medistim Norge ASØkernveien 940579 OsloNorwayPhone +47 23 03 52 50

medistim@medistim.comwww.medistim.com

Guidelines for Flow and Imaging

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Medistim UK Limited34 Nottingham South Ind Est Ruddington LaneWilfordNOTTINGHAMNG11 7EPPhone +44 (0) 115 981 0871

Medistim VeriQ C™ System

System features Flow & Pressure channels

Part number Imaging modes

19” touch screenOnboard color printer500GB patient archiveUSB outputNo calibration required

4 Flow channels2 Pressure channels2 AUX channels

VQ4122C 2D – B ModeCFM – Color Flow Mapping PW – Pulsed Wave Doppler

VQ4122C

Medistim TTFM probes - PS, PQ & PV probe series - available with and without handle

Probe name Probe sizes Part numbers Sterilization methodsMedistim QuickFit™ TTFM

Probes

1.5mm, 2mm, 3mm, 4mm,

5mm, 7mm

PS100011 - PS100072 STERRAD ®

Ethylene Oxide gas (EtO)

Steam autoclave

Medistim QuickFit™ TTFM

Probes

1.5mm, 2mm, 3mm, 4mm, 5mm PQ100011 - PQ100052 STERRAD ®

Ethylene Oxide gas (EtO)

Medistim Vascular TTFM

Probes

6mm, 8mm, 10mm, 12mm,

14mm, 16mm

PV100061 - PV100162 STERRAD ®

Ethylene Oxide gas (EtO)

Steam autoclave

Medistim Ultrasound Imaging probe

Probe name Probe size Part number Sterilization methods

Medistim L15 Ultrasound

Imaging probe

One size EL100015 STERRAD ®

Please refer to the User Manual for indications, contraindications, warnings, precautions, and further specifications and descriptions. Specifications may be changed without no-tice. For a list of flow probes for other applications, contact your Medistim representative.

FDA 510(k) cleared no. K102595FDA 510(k) cleared no. K040228

0470

STERRAD® is a registered trademark of the company ASP.

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:10.1093/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-ope-rative 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. 2007 Nov;20(11):1227-35.

3. 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 2011.