Feature | July 17, 2012| Dave Fornell

An Introduction to Atherectomy Systems

The Bayer-Medrad Navitus atherectomy catheter has two cutting surfaces and integrated aspiration.

Atherectomy devices are used in the cath lab to debulk lesions by cutting or laser ablating plaque, calcium and tissue hyperplasia from vessel walls, allowing recanalization of the vessel lumen as an end in itself, or in preparation for stenting. While some devices have an indication for the coronaries, the primary use of these devices is for peripheral artery disease (PAD) in the legs. 

Healthcare providers are increasingly viewing PAD as a progressive, chronic disease that requires a continuum of treatment, where few patients are treated only once.  Many are treated to restore flow whenever the disease re-occludes a vessel, or a new vessel develops a blockage.  The goal is to improve quality of life and prevent amputation. 

Treatments that restore bloodflow without reducing the ability to treat the vessel in the future are better suited for PAD.  Atherectomy is seen by many as an ideal therapy for PAD because it can restore flow while removing the plaque burden and does not leave behind a permanent obstacle to future treatments, such as a stent. Stenting in the legs leads to frequent restenosis or fractured stent struts, and can be problematic or prevent repeat interventional or open surgical repairs.

Cost of treatment is always a concern for both reimbursement and institutions. Atherectomy may be a less costly approach to PAD over the life of a patient than open surgery or ballooning and stenting.  Within the atherectomy market, the vendors must demonstrate both economic advantages and procedural success. The total cost (including the number) of devices needed for a procedure, the duration of lumen patency and reduction of side effects that require additional treatments influence use of these technologies.

Cardiovascular Systems Inc. (CSI) recently shared 12-month data from the COMPLIANCE 360° study of severely calcified above-the-knee lesions. The prospective study of 50 patients (with 65 lesions) at nine U.S. sites randomized patients equally to balloon angioplasty alone versus the Diamondback Orbital Atherectomy System with adjunctive ballooning.  The study showed that avoiding stents and reducing restenosis saved money. The approximate incremental cost savings of the atherectomy group at six months was $5,264 per additional acute adjunctive stenting or restenosis avoided.  The study also found the angioplasty arm required bailout stenting in 84 percent of the procedures to achieve results equivalent to the Diamondback arm. 

There is increasing interest in atherectomy treatments in vessels below the knee. Successfully recanalizing arteries to the ankle and foot can reduce pain, restore mobility and reverse ulceration, which may have a major impact on the costs of chronic wound care in lower extremities.

There was a setback for coronary atherectomy with the results of the ROTAXUS (A Prospective, Randomized Trial of High-Speed Rotational Atherectomy Prior to Paclitaxel-Eluting Stent Implantation in Complex Calcified Coronary Lesions) trial, presented at the 2011 Transcatheter Cardiovascular Therapeutics (TCT) symposium. The trial found the process was not superior to standard balloon angioplasty and decreased the efficacy of the stent in reducing new tissue growth within the blood vessel.

Drug-eluting stents (DES) are liberally used in complex lesions. Heavily calcified stenoses have not been adequately studied, and form a challenge for immediate and late outcomes. Rotational atherectomy has been shown to effectively modify calcified plaques and facilitate stent delivery and expansion. In patients with complex calcified lesions, rotablation followed by DES seems a rational combination, but there was a lack of evidence prior to the ROTAXUS trial. 

 

Comparing Scanners 

This article served as an introduction to an atherectomy system comparison chart in the July-August 2012 print issue of DAIC. The chart can be accessed in the comparison chart tab at the top of the screen, or at www.dicardiology.com/comparison-charts?t=Atherectomy+Systems  The chart included the following vendors: 

 

Bayer HealthCare (Medrad) - www.interventional.bayer.com

Boston Scientific - www.bostonscientific.com

Covidien - www.turbohawkdevice.com

Cardiovascular Systems Inc. (CSI) - www.csi360.com

Spectranetics - www.spectranetics.com

Related Content

Intact Vascular, TOBA clinical study, one-year results, Tack Endovascular System, Journal of Vascular Surgery
News | Peripheral Arterial Disease (PAD)| August 24, 2016
Intact Vascular Inc. announced that the one-year results from its Tack Optimized Balloon Angioplasty (TOBA) clinical...
Technavio report, renal denervation devices, 2015
News | Renal Denervation| August 23, 2016
August 23, 2016 — Technavio analysts forecast the global...
Jason Burdick, injectable hydrogels, heart failure, heart attack, American Chemical Society

Compared to other types of hydrogels being developed (left), a new hydrogel (right) can form crosslinks after injection into the heart, making the material stiffer and longer-lasting. Image courtesy of American Chemical Society.

News | Heart Failure| August 23, 2016
August 23, 2016 — During a heart attack, clots or narrowed arteries block blood flow, harming or killing cells within
News | Peripheral Arterial Disease (PAD)| August 22, 2016
Avinger Inc. recently announced the closing of its previously announced public offering of 9,857,800 shares of Avinger’...
DMC Heart Hospital, Detroit Medical Center, complex percutaneous intervention education course, PCI, cath lab training
News | Cath Lab| August 22, 2016
The Detroit Medical Center (DMC) Heart Hospital recently completed a Complex Percutaneous Intervention education course...
TAILOR-PCI study, antiplatelet medication, genotype, NHLBI grant
News | Antiplatelet and Anticoagulation Therapies| August 18, 2016
Researchers at the Peter Munk Cardiac Centre, Toronto, and at Mayo Clinic are leading the Tailored Antiplatelet Therapy...
Covidien, Medtronic, TurboHawk, Atherectomy system

The Medtronic TurboHawk atherectomy system. 

Feature | Atherectomy Devices| August 18, 2016 | Dave Fornell
Due to poor outcomes from percutaneous transluminal angioplasty (PTA) ballooning of vessels alone, or of stenting in
Sapien III, Sapien 3, PARTNER III, FDA approval, expanded indication, intermediate risk patients

The Sapien 3 valve has a skirt of fabric at its base that has significantly reduced issues of paravalvular leak, which was an issue with the first generation Sapien device. 

Feature | Heart Valve Technology| August 18, 2016 | Dave Fornell
August 18, 2016 — The U.S.
Corindus Corpath, Acist Medical RXi and CVi, Fairview Southdale Hospital, Minnesota, cath lab
News | Cath Lab| August 17, 2016
Corindus Vascular Robotics Inc. and Acist Medical Systems Inc. are providing Fairview Southdale Hospital, Edina, Minn...
Cardiovascular Systems Inc., LIBERTY 360 study, Amputation Prevention Symposium, PAD, peripheral artery disease, atherectomy
News | Peripheral Arterial Disease (PAD)| August 16, 2016
August 16, 2016 — Cardiovascular Systems Inc.
Overlay Init