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.
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 Case, DISRUPT CAD, Shockwave Breaking News, IVL Technology, Coronary Cases, Coronary Clinical Data, SWAV News, Shockwave C2, Coronary Conferences, Coronary IVL - U.S.
In this three-episode tutorial series, Dr Stefano Fazzini and Dr Michel Bosiers provide an excellent overview on how IVL removes the barriers of calcified hostile access and expands treatment boundaries in EVAR and TEVAR procedures by changing vessel compliance, facilitating luminal gain and significantly reducing complications.
Topics: Peripheral IVL, Peripheral Cases, Peripheral Clinical Data
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: Shockwave Behind-the-Scenes, Coronary IVL, Shockwave Breaking News, IVL Technology, Coronary Cases, Coronary Clinical Data, Shockwave C2, Coronary Conferences, Coronary IVL - U.S., ChalkTalk Podcast
With calcium being as hot of a topic as ever in the interventional community, now is the time to invest in research to better understand its impact across patient populations and trends in modification techniques. Shockwave, in partnership with SCAI, is sponsoring a $50,000 grant for research that improves current understanding of calcified lesions. This one-time grant is eligible for SCAI members within 10 years of completing an Interventional Cardiology fellowship. Research must last 1-year and focus within one of the two following areas:
Applicants are encouraged to access the application instructions at this link. Submissions open May 21, 2022 and close August 1, 2022. Awardees will be notified by September 1, 2022.
We hope this grant improves knowledge & understanding of calcified lesions and further informs us of gender, race and age disparities in coronary calcium modification outcomes.
SCAI Early Career Research Grants presented by Dr Sunil Rao at SCAI 2022
Topics: Shockwave Behind-the-Scenes, Coronary IVL, Shockwave Breaking News, IVL Technology, Coronary IVL - U.S.
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: Shockwave Behind-the-Scenes, Coronary IVL, Shockwave Breaking News, IVL Technology, Coronary IVL - U.S.
This year has been “chalk” full of good vibrations at Shockwave! We launched our most efficient IVL catheter yet, the faster-pulsing Shockwave M5+, and its effects have been helping patients with calcified PAD across the globe ever since. Our data also got deeper, with the Disrupt CAD III one-year data published in JSCAI, demonstrating Coronary IVL’s excellent safety and effectiveness outcomes at 30 days out to one year. We heard from physicians like Dr. B. Clay Sizemore on using Coronary IVL in a no-surgical-backup hospital, and Dr. Alexandra Lansky regarding gender disparities in cardiovascular disease. To top it all off, Fast Company recognized Shockwave as one of the World’s Most Innovative Companies for 2022. Check out all of this and more in the latest PulsePoint Newsletter!
Topics: Coronary IVL, IVL Case, Peripheral IVL, IVL Technology, Coronary Cases, Peripheral Cases, Shockwave C2, Shockwave M5, Shockwave S4, PulsePoint Newsletter, Coronary IVL - U.S., ShockwaveM5+
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: Shockwave Behind-the-Scenes, Coronary IVL, Shockwave Breaking News, IVL Technology, Coronary Cases, Coronary Clinical Data, Shockwave C2, Coronary Conferences, Coronary IVL - U.S., ChalkTalk Podcast
It’s no exaggeration that calcium represents the Achilles heel of endovascular treatment. As the patient population continues to evolve in complexity we need solutions that can treat severe calcified disease in an efficacious, safe and durable way. Listen as Dr Konstantinos Stavroulakis shares the outcomes of his recent publication of Intravascular Lithotripsy (IVL) and DCB in severely calcified femoropopliteal lesions followed out to 12 months and understand why he believes IVL is a game changer in the treatment of complex real world patients.
Topics: Peripheral IVL, Peripheral Cases, Peripheral Clinical Data
In a few weeks, we are headed to a city known for its sunshine and southern hospitality, Atlanta, Georgia, where SCAI 2022 is taking place this year. At the conference, leading calcium experts will share the 1-year results from the Randomized Disrupt PAD III Trial and 1-year sex specific outcomes with Coronary IVL.
Topics: Coronary IVL, IVL Case, Peripheral IVL, Shockwave Breaking News, IVL Technology, DISRUPT PAD, Coronary Cases, Peripheral Cases, PAD Applications - BTK, Peripheral Conferences, SWAV News, Shockwave C2, Coronary Conferences, Shockwave M5, Shockwave S4, PAD Applications - TEVAR, Coronary IVL - U.S., ShockwaveM5+
The presence of calcium can pose significant challenges in achieving optimal procedural outcomes in PAD treatment and can pose as a barrier to the delivery of large bore access devices. Shockwave IVL is shifting the paradigm in the way physicians approach calcium by simplifying procedures in an efficacious and safe manner. Now the next generation of peripheral IVL technology is here: Shockwave M5+! The Shockwave M5+ extends treatment options with the introduction of its new features; faster pulsing, an extended working length and expanded size matrix.
Topics: Peripheral IVL, Peripheral Cases, Peripheral Clinical Data
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.
