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无导线起搏器临床应用的可行性和安全性初探

Initial implantation experience and short-term follow-up results of implanting leadless intracardiac transcatheter pacing system

摘要:

目的:探讨无导线起搏器在临床应用中的可行性及安全性。方法:该研究为前瞻性、观察性研究,选取2019年12月至2020年1月,于北京安贞医院置入Micra无导线起搏器的患者。收集患者的基线临床资料,血小板及血红蛋白的实验室指标,抗凝和/或抗血小板药物使用情况,并行双侧股静脉及髂静脉超声检查。Micra无导线起搏器置入术中记录手术时间、X线透视时间、释放次数和起搏器程控参数(阈值、感知、阻抗)。术后1、3个月行门诊随访,比较置入术中、出院前及随访期间的起搏器程控参数,感知R波振幅≥5 mV,阻抗400~1 500 Ω,阈值与置入术中比较增幅≤1.5 V为起搏器程控参数理想且稳定;记录置入器械相关并发症及严重不良事件,并发症包括股静脉穿刺部位血肿、出血、假性动脉瘤及动静脉瘘,严重不良事件包括置入器械移位、心脏穿孔、心包积液和感染;比较术前及术后1个月的左心室舒张末期内径和射血分数。结果:共纳入5例患者,均为男性,年龄(78.4±8.4)岁,2例服用阿司匹林和氯吡格雷,1例贫血,1例血小板减少,所有患者术前双侧股静脉及髂静脉彩色超声检查未见明显狭窄、闭塞病变,无血管畸形。5例患者均成功置入Micra无导线起搏器,手术时间(39.6±1.7)min,X线透视时间(9.2±1.3)min,释放次数(1.40±0.55)次。起搏器程控参数为,置入术中阈值(0.40±0.10)V/0.24 ms,感知(10.80±3.72)mv,阻抗(822.00±162.23)Ω;出院前阈值(0.45±0.07)V/0.24 ms,感知(13.04±2.41)mV,阻抗(748.0±91.5)Ω;术后1个月阈值(0.40±0.06)V/0.24 ms,感知(14.26±4.11)mV,阻抗(700.0±91.7)Ω;术后3个月阈值(0.39±0.05)V/0.24 ms,感知(14.40±3.97)mV,阻抗(682.0±96.0)Ω,阈值与置入术中比较增幅≤1.5 V,所有参数均在理想范围且稳定。术前及术后1个月的左心室舒张末期内径分别为(44.00±5.24)mm和(44.00±5.34)mm( P=1.000),射血分数分别为(62.00±3.39)%和(62.20±3.56)%( P=0.861),差异均无统计学意义。所有患者均无并发症和严重不良事件发生。 结论:无导线起搏器置入操作简便,创伤小,手术时间短,成功率高,感染风险小,置入安全,但其远期安全性和有效性仍有待进一步研究。

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abstracts:

Objective:To explore the utility and safety of leadless intracardiac transcatheter pacing system.Methods:The study was a prospective observational study. Patients underwent Micra transcatheter pacing system in Beijing Anzhen hospital from December 2019 to January 2020 were enrolled. The baseline characteristics, platelet count, hemoglobin, anticoagulation and/or antiplatelet therapy, mean procedural time, average fluoroscopy time, number of deployment and electrical parameters (threshold, R-wave amplitude, impedance) were recorded. Ultrasonography of bilateral femoral and iliac veins was performed in all patients. Patients were followed including access site complication, adverse event and device evaluation at implant, hospital discharge, 1 and 3 months post-implant. R-wave≥5 mV, impedance between 400 and 1 500 Ω and threshold increase≤1.5 V than implant is considered a stable parameter. Femoral access site complications included hematoma, hemorrhage, pseudoaneurysm, and arteriovenous fistula. Adverse events included dislodgement, cardiac effusion/perforation and infection. Left ventricular end diastolic diameter and ejection fraction before and at 1 month after implant were reported.Results:Five patients were enrolled and pacemaker implantation was successful in all 5 patients. Patients were all males and the average age was (78.4±8.4) years. 2 patients received aspirin and clopidogrel therapy, 1 patient suffered from anemia and thrombocytopenia occurred in 1 patient. No stenosis, occlusion and vascular malformation of bilateral femoral and iliac veins was observed. The mean implant time was (39.6±1.7) minutes. The average fluoroscopy time was (9.2±1.3) minutes and the number of deployment was (1.40±0.55). Electrical parameters(threshold, R-Wave amplitude and impedance) were as follows: (0.40±0.10) V/0.24 ms, (10.80±3.72) mV and (822.00±162.23) Ω at implant; (0.45±0.07) V/0.24 ms, (13.04±2.41) mV, and (748.0±91.5) Ω at discharge, (0.40±0.06) V/0.24 ms, (14.26±4.11) mV, and (700.0±91.7) Ω at 1 month post-implant and (0.39±0.05) V/0.24 ms, 14.40±3.97 mV, and (682.0±96.0) Ω at 3 months post-implant, respectively. Threshold increase was ≤1.5 V compared to that during implantation, electrical parameters were acceptable and stable. There was no difference in LVEDD [(44.00±5.24) mm vs. (44.00±5.34) mm, P=1.000] and EF [(62.00±3.39)% vs. (62.20±3.56)%, P=0.861] before and 1 month post-implant. No incidence of access site complications, cardiac effusion/perforation, dislodgment or infections occurred during the 3 months. Conclusions:The leadless transcatheter pacemaker implantation performed in our study archived a high implant success rate and favorable safety profile as well as associated with low and stable pacing thresholds. The long-term safety and benefit of leadless pacemaker need to be evaluated in future clinical studies.

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