- What does this study add to interventionalists’ daily practice?
Dr. Basavarajaiah: This study provides the safety data on IVL use in real-world population from six-high volume centres that undertake complex coronary intervention. In addition, it also demonstrates the high success rate in completing the procedure with very low event rates during this short-term follow-up.
- How will you describe the baseline demographics of patients included in this study and how does it compare with DISRUPT CAD trials already published?
Dr. Ielasi: From a clinical point of view our study reflects a different nature compared to the DISRUPT CAD studies. Typical clinical predictors of events, such diabetes and CKD, were more represented in our “all-comers” registry as well as the more aggressive interventional approaches, e.g. “rotatripsy”. The lack of a systematic use of intracoronary imaging in our study reflects a real-world practice according to country and regional reimbursement. However, this aspect did not influence the clinical outcome.
- From your perspective what are the key takeaways from this publication?
Dr.: Our study from a real-world practice has shown that the use of IVL in complex calcified coronary lesions appears safe with low rates of complications and high rates of procedural success. In addition, the clinical outcomes are promising with low even rates. This should encourage operators to embrace this novel technology in their daily clinical practice.
- Intravascular imaging was only used in ~1/4 of the cases. What drives the need of use intravascular imaging in this group of patients? Do you think that using intracoronary imaging is mandatory in a real-world setting in order to attain good results with IVL?
Dr. Ielasi: In our study, the use of intravascular imaging was left to operator’s discretion and it was mostly performed in the initial IVL experience (led by the curiosity to assess the IVL effect on calcified lesions) and in case of intra-stent lesions (off label use). Although intravascular imaging is of paramount importance to appreciate the type and extension of the calcifications in the vessel wall, in our experience not using intracoronary imaging to guide PCI did not result in poorer clinical outcomes.
- When intravascular imaging isn’t available how do you decide to use IVL based on angio alone?
Dr.: Degree of calcium can be analysed on the angiogram, although not as accurately as from intra-vascular imaging. If intra-vascular imaging is not available, we would suggest considering IVL only if conventional devices failed to expand the lesion (bailout use of IVL).
- In this paper you present a very simplified algorithm. With the current algorithms previously developed, what compelled you to develop this straightforward and imaging-free algorithm?
Dr. Ielasi: This algorithm provides a simple and practical decision making approach, to treat resistant coronary lesions without the need of intracoronary imaging, while providing some suggestion on when IVL usage should be considered.
Important Safety Information - Coronary IVL
Caution: In the United States, Shockwave C2 Coronary IVL catheters are investigational devices, limited by United States law to investigational use in the DISRUPT CAD III Study. Shockwave C2 Coronary IVL catheters are commercially available in certain countries outside the U.S. Please contact your local Shockwave representative for specific country availability. The Shockwave C2 Coronary IVL catheters are indicated for lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic de novo coronary arteries prior to stenting. For the full IFU containing important safety information please visit: https://shockwavemedical.com/clinicians/international/coronary/shockwave-c2/