McMaster University, Hamilton, ON, Canada; Hamilton Health Sciences, Hamilton, ON, Canada.
Cardiology Division, Heart Center, Luzern, Switzerland; Luzerner Kantonsspital, Luzern, Switzerland.
Cardiovasc Revasc Med. 2023 Jul;52:49-58. doi: 10.1016/j.carrev.2023.02.020. Epub 2023 Mar 2.
Calcified lesions often lead to difficulty achieving optimal stent expansion. OPN non-compliant (NC) is a twin layer balloon with high rated burst pressure that may modify calcium effectively.
Retrospective, multicenter registry in patients undergoing optical coherence tomography (OCT) guided intervention with OPN NC. Superficial calcification with > 180 arc and > 0.5 mm thickness, and/or nodular calcification with > 90 arc were included. OCT was performed in all cases before and after OPN NC, and after intervention. Primary efficacy endpoints were frequency of expansion (EXP) ≥80 % of the mean reference lumen area and mean final EXP by OCT, and secondary endpoints were calcium fractures (CF), and EXP ≥90 %.
50 cases were included; 25 (50 %) superficial, and 25 (50 %) nodular. Calcium score of 4 in 42 (84 %) cases and 3 in 8 (16 %). OPN NC was used alone, or after other devices if further modification was needed, NC in 27 (54 %), cutting in 29 (58 %), scoring in 1 (2 %), IVL in 2 (4 %); or if non-crossable lesion, rotablation in 5 (10 %) cases. EXP ≥80 % was achieved in 40 (80 %) cases with mean final EXP post intervention of 85.7 % ± 8.9. CF were documented in 49 (98 %) cases; multiple in 37 (74 %). There were 1 flow limiting dissection requiring stent deployment and 3 non-cardiovascular related deaths in 6 months follow-up. No records of perforation, no-reflow or other major adverse events.
Among patients with heavy calcified lesions undergoing OCT guided intervention with OPN NC, acceptable expansion was achieved in most cases without procedure related complications.
钙化病变常导致支架扩张不理想。OPN 非顺应性（NC）是一种双层球囊，具有较高的额定爆破压力，可有效修饰钙。
回顾性、多中心注册研究，对接受光学相干断层扫描（OCT）引导下 OPN NC 介入治疗的患者进行分析。纳入标准为钙化病变呈浅弧形且厚度>180 度和/或>0.5mm，或呈结节状且弧形>90 度。所有患者均在 OPN NC 前后及介入治疗后进行 OCT 检查。主要疗效终点为扩张率（EXP）≥80%的平均参考管腔面积和 OCT 测量的平均最终 EXP，次要终点为钙断裂（CF）和 EXP≥90%。
共纳入 50 例患者，其中 25 例（50%）为浅弧形钙化，25 例（50%）为结节状钙化。42 例（84%）患者的钙评分 4 分，8 例（16%）患者钙评分 3 分。OPN NC 单独使用，或在需要进一步修饰时联合其他器械，NC 27 例（54%），切割 29 例（58%），划痕 1 例（2%），IVL 2 例（4%）；如果病变不可交叉，旋磨 5 例（10%）。40 例（80%）患者达到 EXP≥80%，介入治疗后平均最终 EXP 为 85.7%±8.9。49 例（98%）患者有 CF，37 例（74%）患者有多处 CF。6 个月随访中发生 1 例限制血流的夹层，需要支架置入，3 例非心血管相关死亡。无穿孔、无复流或其他主要不良事件记录。
在接受 OCT 引导下 OPN NC 介入治疗的重度钙化病变患者中，大多数患者可获得可接受的扩张，且无与操作相关的并发症。
