Welcome to The Catalyst
Change isn't quick. Unless it's when you experience Intravascular Lithotripsy (IVL) for the first time. Stay apprised of our latest news and insights while discovering how a simple and intuitive tool can be The Catalyst to change the way you think about calcium modification.
Despite often being more challenging to treat, female PCI patients are under-represented in published data, with no dedicated prospective studies performed on this population. To address this unmet need, Shockwave is launching EMPOWER CAD, the first prospective, female-only study of coronary interventions.
Topics: Coronary IVL, IVL Technology, Coronary Clinical Data, Shockwave C2, Coronary Conferences, Treating Different Ca++ Morphologies, Female vs. Male Outcomes
Last month at EuroPCR 2022, Dr Benjamin Honton, from Clinique Pasteur, Toulouse, presented the 1 year follow up pooled OCT analysis from Disrupt CAD III & IV studies, showing that consistent stent expansion and MSA post-IVL resulted in durable clinical outcomes, with no difference in event rates between concentric, eccentric and nodular calcium.
Discover what Dr. Honton thinks about the data and its impact in the treatment of calcified CAD patients in the Q&A below.
1. What does this 1-Year OCT Patient-level Pooled Analysis add to the interventional cardiology community?
The OCT Patient-level Pooled analysis brings meaningful insights into the midterm 12-month impact of OCT findings for patients treated by IVL. This pooled cohort of 160 patients from CAD III and CAD IV demonstrated a low rate of Target Lesion Failure (TLF) (6.9%) at one year with only one subacute stent thrombosis despite complex coronary lesions included in these studies. Moreover, this rate is essentially driven by periprocedural MI with a low rate of events in the follow-up. Interestingly, the OCT independent core-lab analysis showed that the only factor associated with TLF in OCT baseline was a higher maximum calcium arc (328° +/- 48 vs 273° +/- 80; p = 0.03). However, none of the post-stent OCT findings were correlated to the occurrence of TLF, especially those known as strong predictors of cardiovascular events like MSA, maximum stent expansion, or strut malapposition. Moreover, these OCT analyses show that IVL is safe and effective across all types of calcified pattern lesions like eccentric lesions or calcified nodules.
2. From your perspective, what did we learn about the long-term clinical outcomes in calcified nodules and eccentric lesions treated with coronary IVL?
Initially, IVL was studied to target concentric calcified lesions. However, this OCT Patient-level Pooled analysis demonstrates that CAD III and CAD IV studies included patients with eccentric lesions (Calcium Arc <180°; n =30) or calcified nodules (CN; n = 26). These features, particularly CN, remain a significant challenge in our daily practice, often complex to treat with a worst outcome. The OCT Patient-level Pooled analysis brings confidence for IVL in this setting as there is no difference in 12-month TLF in patients treated for a CN or an eccentric calcified lesion than the others. Moreover, post-OCT findings show a mean MSA of 6.2 +/- 2 mm2 with a stent expansion of 101 +/- 18% in the CNs groups confirming the effectiveness of IVL for the management of such complex lesions.
3. How do these outcomes compare with previous reports on the use of rotational atherectomy to treat calcified nodules?
It is always hazardous to compare results from previous studies. However, we can affirm that the rate of complications with IVL for this kind of lesion is drastically low. Moreover, we know that the CNs are more prone to set in the tortuosity of the right coronary artery making the realization of rotational atherectomy (RA) more complex, with a higher risk of complications and a potential guide wire bias impairing RA lesion preparation. In this view, IVL appears to be safer, and the OCT Patient-level Pooled analysis brings clinical evidence that it is also effective. In this perspective, IVL opens new perspectives and should be considered a first-line therapy to prepare CN lesions before stenting.
4. What would you say to your peers who don’t use concomitantly intracoronary imaging with IVL to treat calcified lesions. Do you think that intracoronary imaging is mandatory in a real-world setting in order to attain good results with IVL?
Intracoronary imaging gives meaningful information on calcification patterns ignored by angiography, as calcium angle which is associated with higher TLF in the OCT pool analysis. There is a significant world wild heterogeneity in intracoronary imaging use for multiple reasons. The OCT Patient-level Pooled analysis gives confidence that IVL effectively treats all types of calcium with no procedural adjustment needed for that purpose. In this setting, intravascular imaging could not be mandatory "per se" but remains a valuable tool for planning our PCI strategy with IVL and appreciating stent failure patterns such as malapposition or underexpansion more frequently in the calcified lesion. In this view, intracoronary imagery is expected to increase over time and should be promoted.
For more coronary IVL cases, clinical evidence & conversations, follow @ShockwaveIVL on Twitter!
Topics: Coronary IVL, Coronary Clinical Data, Treating Different Ca++ Morphologies
Discover our PCR webinar featuring European calcium experts, Prof Emanuele Barbato, Prof Javier Escaned, Dr Margaret McEntegart, and Prof Flavio Luciano Ribichini discussing about the most recent OCT data analysis from Disrupt CAD Trials.
Topics: Coronary IVL, IVL Technology, Coronary Clinical Data, Shockwave C2, Treating Different Ca++ Morphologies, Female vs. Male Outcomes
Prof. Javier Escaned, Hospital Universitario Clínico San Carlos, Madrid, and Prof. James Spratt, St George’s University Hospital NHS Trust, London, discussed with Cardiovascular News their views about the latest data from the pooled analysis of 262 patients enrolled in OCT sub-studies from Disrupt CAD I, II, III, & IV.
Topics: Coronary IVL, IVL Technology, Shockwave C2, Treating Different Ca++ Morphologies
Dr. Benjamin Honton, Interventional Cardiologist at Clinique Pasteur, Toulouse, France, together with Dr. Jacques Monsegu, Groupe Hospitalier Mutualiste de Grenoble, France, write about best practices for IVL use in the cath lab based on his 3 years of experience with the technology. In this review you will find IVL technical, scientific and clinical overview, such as lesion selection with focus on concentric and eccentric calcification, analysis of specific clinical indications and some useful tips for crossing and therapy delivery.
Topics: Coronary IVL, IVL Technology, Shockwave C2, Treating Different Ca++ Morphologies
In the latest ChalkTalk podcast, we’re going to listen in on a sponsored discussion that took place with TCTMD during TCT21 about new insights on the latest Coronary IVL data that was presented during the meeting with Drs. Ajay Kirtane, Alexandra Lansky, Matthew Price, and Ziad Ali. Hope you enjoy the conversation and for more information on the data, please visit LetsGetCracking.com.
Topics: Coronary IVL, IVL Technology, SWAV News, ChalkTalk Podcast, Treating Different Ca++ Morphologies, Female vs. Male Outcomes
Q&A with Dr. Akiko Maehara about the Disrupt CAD Pooled OCT Calcific Nodules Analysis at TCT21
Topics: Coronary IVL, Coronary Clinical Data, Shockwave C2, Treating Different Ca++ Morphologies
Q&A with Dr. Ziad Ali about the Disrupt CAD Pooled OCT Eccentric vs Concentric Analysis at TCT21
Topics: Coronary IVL, Coronary Clinical Data, Treating Different Ca++ Morphologies
We’ve all heard that Shockwave IVL doesn’t work in eccentric calcium… well that’s just a myth. Watch Prof. Andrew Holden’s presentation from CIRSE21 as he walks you through IVL’s eccentric vs concentric lesion data subset from the PADIII Observational Study and learn how this myth can well and truly be dispelled.
Topics: Peripheral IVL, Peripheral Conferences, Peripheral Clinical Data, Treating Different Ca++ Morphologies
Eccentric calcium has challenged current modalities’ ability to adequately modify calcium due to several device-dependent factors. NC balloons often expand the healthy, non-calcified side of the artery, while high pressure or cutting balloons may result in disruption or dissection of healthy intima. Even atherectomy devices are limited due to wire bias that may often result in nonuniform ablation of calcium leaving the calcified plaque untouched.
Topics: Coronary IVL, Shockwave C2, Treating Different Ca++ Morphologies
But, right now we're in the early phases of the R&D program. In the meantime, don't miss the IVL application that heart teams are embracing already — maintaining transfemoral TAVR access through heavily calcified iliacs by using IVL.
