Single-center experience with novel approach "coronary intravascular lithotripsy" (IVL, SHOCKWAVE) to lesion preparation of severely calcified plaques: feasibility, safety, and 30 day-outcomes

https://doi.org/10.1007/s00392-024-02526-y

Madan Raj Poudel (Bielefeld)1, D. Lawin (Bielefeld)1, A. I. Diaconescu (Bielefeld)1, T. Lawrenz (Bielefeld)1, M. Skasa (Bielefeld)1, A. Tego (Bielefeld)1, K. Marx (Bielefeld)1, C. Stellbrink (Bielefeld)1

1Universitätsklinikum OWL Klinik für Kardiologie und intern. Intensivmedizin Bielefeld, Deutschland

 

Background:
Severe coronary calcification remains a challenge for the interventional cardiologist in daily practice with the risk of impaired stent expansion constituting a major predictor for stent thrombosis and re-stenosis. In recent years, different techniques, such as rotational & orbital atherectomy and high-pressure and cutting balloon dilation, were established to treat heavy coronary calcification. Intravascular lithotripsy (IVL) is a novel method for lesion preparation using ultrasound-based fracturation of calcification to allow for effective stent deployment. However, data on clinical outcome are scarce. Thus, we retrospectively analyzed feasibility, safety and 30 day-outcomes in patients (pts) who underwent IVL for the treatment of highly calcified coronary stenosis at our institution.

Methods:
We retrospectively assessed 35 patients (pts) with symptomatic coronary artery disease (CAD) including acute coronary syndrom (ST-elevation myocardial infarction (STE-ACS) & non-ST segment elevation acute coronary syndrome (NSTE-AC) with at least one highly calcified stenosis requiring revascularization (assessed by fractional flow reserve or diastolic flow ratio) who were treated with IVL at our institution. Acute angiographic success was defined as achieving <25 % residual stenosis without edge dissection. All procedure-related and in-hospital complications were recorded. Follow-up was performed 30 days after intervention via telephone inquiries.

 

Results:
35 pts (20% female, median age IQR 77(68-84) years, 55% with 3-vessel-CAD) were treated with IVL. All pts had a previously failed percutaneous coronary intervention (PCI) due to suboptimal initial balloon pre-dilation. IVL was applied in 5 pts with left main stenosis (Fig 1), in 15 pts (43%) with (NSTE-ACS), and in 1 patient with STE-ACS. 2 pts were hemodynamically unstable throughout the procedure and required a left ventricular assist device (Impella pump®). Intravascular imaging was applied in 7 (20%) pts. Acute angiographic success was achieved in 90 %. In all cases pre- and post-dilatation was applied. We observed 3 IVL failures (2 patients were converted to rotational atherectomy, 1 patient was referred for surgery, due to the complexity of the anatomy). Despite a pressure of 4 to 6 atm, as recommended, IVL balloon rupture was observed in 2 pts but was not associated with any complications. There were no peri-procedural myocardial infarctions but one coronary dissection occurred without further complications. 3 pts with NSTE-ACS died during the hospital stay (1 due to cardiogenic, 1 due to septic shock and 1 due to the gastro-intestinal bleeding) despite acute angiographic success using IVL. During 30 days-FU after discharge, there were no deaths or other cardiovascular events among the other patients.

Conclusion:
In our investigation, IVL was safe, effective, feasible and facilitated successful stent implantation in 90 % of our patients. It is a safe procedure with a good success rate and low rate of complications. IVL might be a valuable adjunct to PCI providing focal calcium modification with limited localized injury to the endovascular surface.

 

 

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