Safety Profile of Non Compliant Balloon Dilatation Catheter for Predilatation and Postdilatation in Patients Undergoing Percutaneous Coronary Intervention: A Retrospective Observational Study

Introduction: Despite advancements in drug-eluting stents, the risk of restenosis and adverse events remains high, especially in complex coronary lesions, highlighting the need for optimal lesion preparation and stent deployment. Aim: To evaluate the procedural performance and safety profile of the WILMA Non Compliant (NC) Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon dilatation catheter (Sahajanand Medical Technologies Limited, Surat, India) in patients with Coronary Artery Disease (CAD) undergoing Percutaneous Coronary Intervention (PCI) in lesions requiring predilatation or postdilatation. Materials and Methods: This investigator-initiated, retrospective, single-center, observational study was conducted at the Cardiology department of Shree BD Mehta Mahavir Heart Institute, Surat, India, from September 2016 to June 2017. One hundred forty-seven lesions from 147 consecutive patients who had undergone PCI with pre or postdilatation using the Wilma-NC PTCA balloon dilatation catheter were included. Device-Oriented Composite Endpoints (DOCE)-a composite of cardiac death, Myocardial Infarction (MI), and target lesion revascularisation during the hospital stay-and Patient Oriented Composite Endpoints (POCE)-a composite of all-cause mortality, any MI, and any repeat revascularisation—during the hospital stay were considered as primary safety endpoints, while device and procedural success were considered as primary performance endpoints. Continuous variables were described as means and standard deviations, and categorical variables were described as frequency counts and percentages. Results: The mean age of patients was 64.0±10.4 years with a male predominance 119 (81.0%). Moderate to severe vessel tortuosity and calcification were noted in 45 (30.6%) and 42 (28.6%) lesions, respectively. All 147 (100%) patients achieved device success, lesion success, and procedural success. There were no procedural complications such as coronary artery perforation, coronary artery dissection, distal embolisation, slow flow/no-reflow phenomenon, side branch occlusion, or systemic bleeding complications observed during the hospital stay. Access site-related complications such as hematoma, pseudoaneurysm, arteriovenous fistula, and infection were absent. No adverse events (DOCE and POCE) were reported during the hospital stay. Conclusion: The results of this observational study confirm the excellent performance and safety profile of the Wilma-NC PTCA balloon dilatation catheter in patients with CAD undergoing PCI in lesions requiring predilatation or postdilatation.