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
At Shockwave, we are committed to doing everything we can to narrow the PCI gender inequality gap starting with clinical evidence presented at SCAI 2022 where Coronary IVL demonstrated sustained long term clinical outcomes and excellent safety in both women and men suggesting first line use of Coronary IVL for plaque modification in female patients with calcified lesions.
Topics: Coronary IVL, IVL Technology, Coronary Clinical Data, SWAV News, Shockwave C2, Coronary Conferences, Female vs. Male Outcomes
Leading female interventionalists came together at SCAI 2022 to discuss what they are most excited about in the interventional space today, share key takeaways from SCAI, and discuss the female focused initiatives that will help bridge the PCI gap in gender disparities going forward. From the JSCAI expert consensus, gender focused clinical evidence highlights at SCAI, and future research to SCAI WIN initiatives, these female leaders covered it all.
Listen to the podcast with Dr. Dawn Abbott, MD, Rhode Island Hospital, Dr. Suzanne Baron, MD, Lahey Hospital and Medical Center, Dr. Alexandra Lansky, MD, Yale University School of Medicine, Yale University and Dr. Nadia Sutton, MD, University of Michigan.
We hope you enjoy the episode and for more information on coronary IVL in women, please visit TimeForAnIntervention.com.
Topics: Coronary IVL, IVL Technology, Coronary Clinical Data, Shockwave C2, Coronary Conferences, ChalkTalk Podcast, 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
In episode #9 of the ChalkTalk podcast, we speak with Alexandra Lansky, MD, FACC, FAHA, FSCAI, FESC, Professor of Medicine in Cardiology, and Director of Yale Cardiovascular Clinical Research Program at Yale University School of Medicine in New Haven, Connecticut, about her recent gender analyses at TCT21 and SCAI22, in which she presented the respective 30-day and 1-year outcomes broken out by women vs men that were enrolled in the Disrupt CAD clinical program.
Dr. Lansky shares the genesis of the analysis - previous research showing that female atherectomy patients have an increased risk for angiographic complications than their male counterparts,[i] and sheds light on what makes coronary IVL unique from a safety perspective. She concludes by discussing the recent publication of SCAI’s “Expert Consensus Statement on Sex-Specific Consideration in Myocardial Revascularization” in JSCAI, which referenced the role of IVL in female patients. The SCAI guidelines concluded, “while additional evidence is needed, these results taken in the context of outcomes with atherectomy devices suggest that IVL may emerge as a first-line therapy for plaque modification of calcified lesions in women specifically.”
We hope you enjoy the episode and for more information on coronary IVL in women, please visit TimeForAnIntervention.com.
Topics: Coronary IVL, IVL Technology, Coronary Clinical Data, SWAV News, Shockwave C2, Coronary Conferences, ChalkTalk Podcast, Female vs. Male Outcomes
Some of us know the data. Some don’t. The question once you do is where we go from here to bridge the gender inequality gap?
Topics: Coronary IVL, IVL Technology, Coronary Clinical Data, Shockwave C2, Female vs. Male Outcomes
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
Disrupt CAD Pooled Gender Analysis is now in published in JSCAI - the new journal of the Society for Cardiovascular Angiography & Interventions. Read the JSCAI publication here: https://www.jscai.org/article/S2772-9303(21)00011-9/fulltext
Topics: Coronary IVL, IVL Technology, Coronary Clinical Data, Shockwave C2, Female vs. Male Outcomes
The one-year Disrupt CAD III data has been published in JSCAI – the new journal of the Society for Cardiovascular Angiography & Interventions. The new data from Disrupt CAD III confirm the consistency of the excellent safety and effectiveness outcomes at 30 days out to one year.
Topics: Coronary IVL, IVL Technology, Coronary Clinical Data, Shockwave C2
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
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.
