TCTAP A-019 Short Term and Mid Term Outcomes of Intravascular Lithotripsy (IVL) in Patients With Moderate to Severe Calcific Coronary Artery Disease (CAD)

ABSTRACT

Background: Moderate to severe coronary calcification results in suboptimal results with increased risk of procedural and future adverse events. Newer high-pressure balloons and atherectomy devices have not shown any superiority over the routine high pressure balloon dilatation. Intravascular lithotripsy (IVL) is the latest technique for treatment of moderate to severe calcific coronary artery disease. IVL converts the electrical energy into mechanical energy with cracking of calcium in both adventitia and intima. DISRUPT CAD III study has shown the short-term outcomes of Intravascular lithotripsy (IVL). However, the experience is limited with this new technique especially for mid-term and long-term outcomes. The Coronary IVL System is a proprietary balloon catheter system designed to enhance stent outcomes by enabling delivery of the calcium disrupting capability of lithotripsy prior to balloon dilatation at low pressures. The Coronary IVL System consists of an IVL Balloon Catheter with two integrated pairs of lithotripsy emitters, a Lithotripsy Generator, and Connector Cable. Methods: Our study is a single centre, observational study done at Apollo hospitals, Visakhapatnam, India, to evaluate the safety, mid-term and long-term effectiveness of Intravascular Lithotripsy (IVL). Subjects who are more than 18 years of age with moderate to severe calcification which require Percutaneous Coronary Intervention (PCI) and are willing to participate in the study are included. Baseline parameters were assessed. Procedural success was defined as no residual stenosis of <30% after stenting. Procedural and postprocedural complications were noted. Usage of adjuvant Atherectomy balloons or devices is noted. Both clinical and angiographic follow up was done. Clinical follow up parameters assessed were MACE which includes cardiac death, MI, target vessel revascularisation (TVR), Target lesion revascularisation (TVR). Any admissions for heart failure or change in functional class are also noted. On follow up, Angiographic assessment was done for In-stent restenosis (>50%) or In segment restenosis (>50%) or any fresh coronary lesions which mandates revascularisation. Results: Out of 35 subjects, only 2 were females. Mean age was 69.9 ± 2.8 years. 15 (42.8%) subjects were Diabetics and 17 (48.5%) were Hypertensives. 2 subjects underwent previous CABG surgery. 10 subjects had left ventricular dysfunction. 2 subjects had renal dysfunction. 29 (82.8%) subjects presented with Acute MI out of which 22 were presented with NSTEMI. 1 subject underwent the procedure during Primary PTCA successfully. Total number of stents implanted were4 1 with a mean stent implantation was 1.17. Rotablation system (Boston Scientific) was used in 2 subjects prior to IVL where the intimal calcium was extensive. OPN NC balloon (Translumina Therapeutics) was used in 6 subjects. Mean stent length was 35.9 ± 9.8 mm. Mean number of pulses delivered was 7.3 ± 1.4. All the subjects had good procedural outcomes with no residual stenosis. Only 1 subject had coronary dissection after IVL which could be stented successfully. 1 subject had an aneurysm in the proximal LAD which could be stented. Subjects were followed up clinically for a mean of 6.23 months. No MACEs were noted. None of them had any Heart failure admissions. 1 subject died of noncardiac cause (respiratory failure due to COVID-19 pneumonia). 7 patients followed up angiographically after a mean follow up of 9.4 months. No significant ISR was noted in any of them. 1 subject underwent repeat target vessel revascularisation (TVR). Another subject underwent revascularisation to another vessel which was planned earlier. Conclusion: Coronary Intravascular lithotripsy (IVL) is a safe and effective method in the treatment of moderate to severe coronary calcific coronary artery disease which is safe and effective with good short-term and mid-term outcomes. However, the data is limited on long-term outcomes.