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Feasibility of intravascular lithotripsy for calcific coronary lesions: A multi-institutional experience
Sylwia Iwańczyk1, Adrian Włodarczak2, Jarosław Hiczkiewicz3
1Department of Cardiology, Poznan University of Medical Sciences, Poznań, Poland.
Insights
Intravascular lithotripsy (IVL) effectively treats severe calcified coronary lesions, improving stent expansion. This study confirms IVL as a safe alternative to traditional methods, reducing procedural complications and enhancing patient outcomes.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- Severe calcified atherosclerotic lesions pose treatment challenges, with existing methods like balloon angioplasty and atherectomy having limitations and risks.
- Intravascular lithotripsy (IVL) has emerged as a potentially safer and more feasible alternative for modifying these complex lesions.
Purpose of the Study:
- To evaluate the safety and performance of intravascular lithotripsy (S-IVL) in treating severe calcified atherosclerotic lesions.
- To assess the efficacy of S-IVL in optimizing stent expansion and reducing the need for complex lesion preparation.
Main Methods:
- A consecutive series of 46 patients treated with S-IVL for severe calcified coronary lesions between May 2019 and June 2020 were analyzed.
- Device safety was assessed by 30-day major adverse cardiac events (MACE), while device and clinical success rates were primary performance endpoints.
Main Results:
- S-IVL achieved high device success (97.8%) and clinical success (95.6%) rates, significantly reducing diameter stenosis from 80% to 5.2%.
- The 30-day MACE rate was low, with one probable subacute stent thrombosis. At 6-month follow-up, MACE rate was 6.2%, with one target lesion revascularization.
Conclusions:
- S-IVL is a safe and effective modality for coronary calcium modification, facilitating optimal stent expansion.
- In select cases, S-IVL can replace more complex lesion preparation techniques like atherectomy, potentially improving procedural outcomes.
Objective:
We sought to determine the safety and performance of intravascular lithotripsy in the treatment of severe calcified atherosclerotic lesions.
Background:
The modification of severe calcified atherosclerotic lesions with noncompliant or specialty balloons, as well as orbital or rotational atherectomy has limitations and may be ineffective, increasing the risk of periprocedural complications and worsening long-term results. Intravascular lithotripsy has recently been shown to be a safe and feasible alternative to the above methods.
Methods:
All consecutive patients treated with Shockwave Medical Intravascular Lithotripsy (S-IVL) between May 2019 and June 2020 were included in current analysis. Device safety and efficacy were the critical endpoints of the study. The primary safety endpoint was 30-day major adverse cardiac events (MACE). In turn, device and clinical success were the primary performance endpoints.
Results:
In total, 46 patients undergoing percutaneous coronary intervention were treated with S-IVL before stent deployment (65% male; age, 71 ± 7 years). Device success was achieved in 45 (97.8%) patients with reduction of diameter stenosis from 80% to 5.2% with an acute gain of 2.5 mm. Clinical success was demonstrated in 95.6% of cases. During the 30-day follow-up, one sudden death was recorded, regarded as probable subacute stent thrombosis. During 6-month follow up one target lesion and target vessel revascularizations occurred. The rate of MACE after 6 month was 6.2%.
Conclusions:
S-IVL appears to be a safe and effective treatment modality in coronary calcium modification to optimize stent expansion. In selected cases this device obviates the need for more complex lesion preparation strategies such as atherectomy.
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