A lumen sizing workhorse guidewire for peripheral vasculature: Two functions in one device

Svendsen, Mark; Choy, Jenny S.; Ebner, Adrián; Bigelow, Brian; Sinha, Anjan; Moussa, Issam; Akingba, A. George; Combs, Bill; Kassab, Ghassan S.

doi:10.1002/ccd.24950

Cited by 5 publications

(2 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Since the strut thickness is relatively small, the sizing measurements is essentially that of lumen area or MSA. Furthermore, although the measurements were made on a conductance catheter, the methodology presented is completely translatable to a sizing guidewire as shown in peripheral arteries of animals and patients (Svendsen et al, 2014b; Nair et al, 2018). For example, our peripheral guidewire can size the Supera (Abbott) or the Viabahn (Gore) as neither of these devices is electrically conductive.…”

Section: Discussionmentioning

confidence: 99%

Electrical Conductance Device for Stent Sizing

Kassab

2019

Front. Physiol.

Self Cite

View full text Add to dashboard Cite

The minimum stent area (MSA) has been clinically established as a significant predictor of restenosis, thrombosis, and ischemia using intra-vascular ultrasound (IVUS). Unfortunately, IVUS measurements are far from routine because of significant cost of IVUS, the training required, the subjectivity of image interpretation and the time added to the procedure. The objective of this study is to verify the accuracy of a conductance catheter for stent sizing. Here, we introduce an easy and entirely objective device and method for real time determination of MSA. A 10 kHz, 35 μA rms current is passed through the external electrodes of an intravascular catheter while the conductance is measured across a separate set of electrodes. Both phantom and ex vivo validations of metal stent sizing in five porcine carotid arteries were confirmed. The accuracy of the measurements were found to be excellent in phantoms (root mean square, rms, of 3.4% of actual value) and in ex-vivo vessels (rms = 3.2% of measured value). An offset of conductance occurs when a conductive metal stent (e.g., bare metal stent) is deployed in the vessel, while the slope remains the same. This offset is absent in the case of drug eluting stent where the metal is coated (i.e., insulated) or non-metal bioresorbable stent. The present device makes easy, accurate and reproducible measurements of the size of stented blood vessels within 3.2% rms error. This device provides an alternative method to sizing of stent (i.e., MSA) in real-time without subjective interpretation and with less cost than IVUS.

show abstract

Section: Discussionmentioning

confidence: 99%

Electrical Conductance Device for Stent Sizing

Kassab

2019

Front. Physiol.

Self Cite

View full text Add to dashboard Cite

show abstract

“…The electrical signals generated in the SVCB catheter were extremely safe (no major arrhythmias, events, or complications) due to the isolated environment created by the balloon and the small, high‐frequency nature of the current. Further assurance of the current safety has already been proven in catheters and guidewires where there was no balloon to provide insulation and the current was injected directly into the coronary and peripheral arteries of humans (no safety concerns or adverse events) and animals . Hence, even if the balloon were to rupture, this would pose no electrical risk to the patient.…”

Section: Discussionmentioning

confidence: 99%

Two‐in‐one aortic valve sizing and valvuloplasty conductance balloon catheter

Svendsen

Sinha

Berwick

et al. 2015

Cathet Cardio Intervent

Self Cite

View full text Add to dashboard Cite

Background Inaccurate aortic valve sizing and selection is linked to paravalvular leakage in transcatheter aortic valve replacement (TAVR). Here, a novel sizing valvuloplasty conductance balloon (SVCB) catheter is shown to be accurate, reproducible, unbiased, and provides real-time tool for aortic valve sizing that fits within the standard valvuloplasty procedure. Methods & Results The SVCB catheter is a valvuloplasty device that uses real-time electrical conductance measurements based on Ohm’s Law to size the balloon opposed against the aortic valve at any given inflation pressure. Accuracy and repeatability of the SVCB catheter was performed on the bench in phantoms of known dimension and ex vivo in 3 domestic swine aortic annuli with comparison to computed tomography (CT) and dilator measurements. Procedural workflow and safety was demonstrated in vivo in 3 additional domestic swine. SVCB catheter measurements had negligible bias or error for bench accuracy considered as the gold standard (Bias: −0.11 ± 0.26 mm; Error: 1.2%), but greater disagreement in ex vivo versus dilators (Bias: −0.3 ± 1.1mm; Error: 4.5%), and ex vivo versus CT (Bias: −1.0 ± 1.6 mm; Error: 8.7%). The dilator versus CT accuracy showed similar agreement (Bias: −0.9 ± 1.5 mm; Error: 7.3%). Repeatability was excellent on the bench (Bias: 0.02 ± 0.12 mm; Error: 0.5%) and ex vivo (Bias: −0.4 ± 0.9 mm; Error: 4.6%). In animal studies, the device fit well within the procedural workflow with no adverse events or complications. Conclusions Due to the clinical relevance of this accurate, repeatable, unbiased, and real-time sizing measurement, the SVCB catheter may provide a useful tool prior to TAVR. These findings merit a future human study

show abstract