This case was the winner of the inaugural TopShock case competition at TCT 2019 – a satellite symposium sponsored by Shockwave Medical. This post was written by Dr. Thomas E. Waggoner for The Catalyst.
Transcatheter aortic valve replacement (TAVR) is most commonly performed through iliofemoral (groin) access. This access route is the default and is performed in approximately 90% of cases across the US. The other 10% of those cases, however, require some form of alternative access route, often due to extensive calcification of the iliofemoral arteries that would not allow safe passage of the TAVR delivery sheath.
I perform 175 TAVR cases per year at Pima Heart in Tucson, Arizona. In my practice, less than 5% of those cases require some form of alternative access due to calcium.
The case that I presented at TCT 2019 was an extreme one. It was a 73 year old frail woman with severe aortic stenosis, a porcelain aorta, stenoses of the subclavian and carotid arteries and Leriche syndrome of the distal aorta. There were few good options for this patient.
Transaxillary would generally be my second-line approach to patients with challenging access. But this patient had 3mm axillary-subclavians. Transcaval and Direct Aortic approaches were not options due to the porcelain aorta. Transcarotid was out due to the carotid stenoses. A high-morbidity trans-apical approach may have still been possible but, frankly, we hadn’t performed one in years.
I elected to try IVL. I gained wire access through the occluded distal aorta and used a 4mm non-compliant balloon to ensure that the IVL catheter could pass. I then used a 7.0mm IVL catheter and delivered 240 pulses, which took less than 10 minutes total. I also implanted an Omnilink BMS. The patient was sent home post-operative day one.
One week later, we easily accessed and delivered a 23mm Edwards Sapien 3 TAVR device through the right femoral. Delivery was completely successful and uneventful, with no PVL or conduction disturbance.
In this patient, IVL offered an option to deliver a TAVR device when I feel that I had very few other options. Other alternative access approaches are important to know and to maintain skill in, but IVL may simplify a significant proportion of our alternative access cases going forward.
Important Safety Information
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Indication for Use – The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
Contraindications – Do not use if unable to pass 0.014 guidewire across the lesion • Not intended for treatment of in-stent restenosis or in coronary, carotid, or cerebrovascular arteries.
Warnings – Only to be used by physicians who are familiar with interventional vascular procedures • Physicians must be trained prior to use of the device • Use the Generator in accordance with recommended settings as stated in the Operator’s Manual
Precautions – Use only the recommended balloon inflation medium • Appropriate anticoagulant therapy should be administered by the physician • Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology
Adverse Effects – Possible adverse effects consistent with standard angioplasty include: • Access site complications • Allergy to contrast or blood thinners • Arterial bypass surgery • Bleeding complications • Death • Fracture of guidewire or device • Hypertension/Hypotension • Infection/sepsis • Placement of a stent • Renal failure • Shock/pulmonary edema • Target vessel stenosis or occlusion • Vascular complications. Risks unique to the device and its use: • Allergy to catheter material(s) • Device malfunction or failure • Excess heat at target site
Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions, and adverse events. www.shockwavemedical.com