Author + information
- Nabil Dib1,
- Richard A. Shlofmitz2,
- John M. Hodgson3,
- Robert Kohler4,
- Jennifer Olson5,
- Bynthia M. Anose5,
- Brad Martinsen5 and
- Jeffrey W. Chambers6
- 1Mercy Gilbert Medical Center, Gilbert, AZ
- 2St. Francis Hospital: Heart Center, Roslyn, NY
- 3MetroHealth Medical Center & Technology Solutions Group, Moreland Hills, OH
- 4International Society of Cardiovascular Translational Research, Lake Elmo, MN
- 5Cardiovascular Systems, Inc., St. Paul, MN
- 6Metropolitan Heart and Vascular Institute: Mercy Hospital, Minneapolis, MN
Reduced flow and no reflow are known complications associated with rotational atherectomy and attributed to dysfunction of the microcirculation. Coronary microcirculation dysfunction post-PCI can cause myocardial ischemia. Previous coronary artery flow reserve (CFR) studies on rotational atherectomy (RA) have shown a failure to normalize CFR post-procedure, likely due to the embolization of debris post atherectomy or to platelet activation. The impact of orbital atherectomy (OA) on CFR, however, is currently unknown.
The purpose of this prospective, multi-center clinical study was to evaluate the coronary microcirculation function by measuring CFR following successful treatment of de novo severely calcified coronary lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS; CSI, St. Paul, MN) and stenting. Fifteen consecutive subjects with coronary calcification > 15 mm, vessel diameter > 2.5 mm and who had successful coronary stent placement with no procedural complication, were enrolled at 3 U.S. sites. After each successful procedure, the CFR was measured 1-2 cm distal to the distal end of the stent using the Volcano Doppler FloWire and intracoronary adenosine (40-100 mcg). Images were analyzed by a core lab (MetroHealth Medical Center & Technology Solutions Group, Moreland Hills, OH).
The average CFR post-procedure (OAS and successful stent placement) was 2.23±.33, signifying a normalization of CFR. Baseline and hyperemic velocities were 16 and 36, respectively, with no Major Adverse Cardiac Events (MACE; cardiac death, acute myocardial infarction—Q wave or non-Q wave, and target vessel revascularization). Complete study design, patient demographics, CFR core-lab analysis, and post-procedural data will be presented.
The use of OA does not have a negative effect on CFR and seems to preserve the function of the microcirculation during the treatment of severely calcified coronary lesions. This has significant clinical implications in that it may minimize arrhythmias and the need for pacemaker placement/activation during OAS treatment and can be used on patients with reduced ejection fraction with minimal risk. This is likely attributed to the orbital action of the device that allows for continuous flow during treatment - minimizing a bolus embolization effect, slow-flow/no-reflow, and reduced CFR.