Safety, efficacy, and optical coherence tomography insights into intravascular lithotripsy for the modification of non-eruptive calcified nodules: A prospective observational study

IF 2.1 3区医学 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS

Catheterization and Cardiovascular Interventions Pub Date : 2024-09-03 DOI:10.1002/ccd.31217

Ankush Gupta MD, DM, Abhinav Shrivastava MD, DM, Sanya Chhikara MBBS, Pruthvi C. Revaiah MD, DM, Mamas A. Mamas MBChB, DPhil, Rajesh Vijayvergiya MD, DM, Ashok Seth FRCP, MSCAI, Balwinder Singh MD, DNB, Nitin Bajaj MD, DM, Navreet Singh MD, DM, Jaskarn Singh Dugal MD, DM, Nalin K. Mahesh MD, DNB

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引用次数: 0

Abstract

Background

Non-eruptive calcium nodules (CNs) are commonly seen in heavily calcified coronary artery disease. They are the most difficult subset for modification, and may result in stent damage, malapposition and under-expansion. There are only limited options available for non-eruptive CN modification. Intravascular lithotripsy (IVL) is being explored as a potentially safe and effective modality in these lesions.

Aims

This study aimed to investigate the safety and efficacy of the use of IVL for the modification of non-eruptive CNs. The study also explored the OCT features of calcium nodule modification by IVL.

Methods

This is a single-center, prospective, observational study in which patients with angiographic heavy calcification and non-eruptive CN on OCT and undergoing PCI were enrolled. The primary safety endpoint was freedom from perforation, no-reflow/slow flow, flow-limiting dissection after IVL therapy, and major adverse cardiac events (MACE) during hospitalization and at 30 days. MACE was defined as a composite of cardiac death, myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR). The primary efficacy endpoint was procedural success, defined as residual diameter stenosis of <30% on angiography and stent expansion of more than 80% as assessed by OCT.

Results

A total of 21 patients with 54 non-eruptive CNs undergoing PCI were prospectively enrolled in the study. Before IVL, OCT revealed a mean calcium score of 3.7 ± 0.5 and a mean MLA at CN of 3.9 ± 2.1 mm². Following IVL, OCT revealed calcium fractures in 40 out of 54 (74.1%) CNs with an average of 1.05 ± 0.72 fractures per CN. Fractures were predominantly observed at the base of the CN (80%). Post IVL, the mean MLA at CN increased to 4.9 ± 2.3 mm². After PCI, the mean MSA at the CN was 7.9 ± 2.5 mm². Optimal stent expansion (stent expansion >80%) at the CN was achieved in 85.71% of patients. All patients remained free from MACE during hospitalization and at the 30-day follow-up. At 1-year follow-up, all-cause death had occurred in 3 (14.3%) patients.

Conclusions

This single-arm study demonstrated the safety, efficacy, and utility of the IVL in a subset of patients with non-eruptive calcified nodules. In this study, minimal procedural complications, excellent lesion modifications, and favorable 30-day and 1-year outcomes were observed.

Abstract Image

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血管内碎石术治疗非破裂性钙化结节的安全性、疗效和光学相干断层成像：前瞻性观察研究。

背景：非破裂性钙质结节（CNs）常见于严重钙化的冠状动脉疾病。它们是最难改造的子集，可能导致支架损伤、错位和扩张不足。对于非破裂性冠状动脉钙化的改造，可供选择的方案非常有限。目的：本研究旨在探讨使用血管内碎石术（IVL）改造非破裂性 CN 的安全性和有效性。方法：这是一项单中心、前瞻性的研究：这是一项单中心、前瞻性、观察性研究，研究对象为血管造影显示重度钙化、OCT 显示非破裂性 CN 并接受 PCI 治疗的患者。主要安全终点是IVL治疗后无穿孔、无回流/低流量、限流夹层，以及住院期间和30天后无重大心脏不良事件（MACE）。MACE 被定义为心源性死亡、心肌梗死（MI）和缺血驱动的靶病变血运重建（TLR）的综合结果。主要疗效终点是手术成功，定义为残余直径狭窄结果：共有 21 名患者接受了 PCI 治疗，其中有 54 例为非破裂性 CN 病变。IVL 前，OCT 显示平均钙化评分为 3.7 ± 0.5，CN 处的平均 MLA 为 3.9 ± 2.1 mm2。IVL 后，OCT 显示 54 个 CN 中的 40 个（74.1%）存在钙化骨折，平均每个 CN 有 1.05 ± 0.72 处骨折。骨折主要发生在 CN 的基底（80%）。IVL 后，CN 处的平均 MLA 增至 4.9 ± 2.3 mm2。PCI 后，CN 处的平均 MLA 为 7.9 ± 2.5 mm2。85.71%的患者实现了CN处的最佳支架扩张（支架扩张>80%）。所有患者在住院期间和 30 天随访时均未发生 MACE。随访1年时，3名患者（14.3%）因各种原因死亡：这项单臂研究证明了IVL在非溃疡性钙化结节患者中的安全性、有效性和实用性。在这项研究中，观察到了极少的手术并发症、极好的病灶改变以及良好的30天和1年疗效。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Catheterization and Cardiovascular Interventions 医学-心血管系统

CiteScore

5.40

自引率

8.70%

发文量

419

审稿时长

2 months

期刊介绍： Catheterization and Cardiovascular Interventions is an international journal covering the broad field of cardiovascular diseases. Subject material includes basic and clinical information that is derived from or related to invasive and interventional coronary or peripheral vascular techniques. The journal focuses on material that will be of immediate practical value to physicians providing patient care in the clinical laboratory setting. To accomplish this, the journal publishes Preliminary Reports and Work In Progress articles that complement the traditional Original Studies, Case Reports, and Comprehensive Reviews. Perspective and insight concerning controversial subjects and evolving technologies are provided regularly through Editorial Commentaries furnished by members of the Editorial Board and other experts. Articles are subject to double-blind peer review and complete editorial evaluation prior to any decision regarding acceptability.