被动起搏电极参数随访分析
摘要
研究背景:起搏电极一直是起搏治疗最脆弱的环节,起搏器在其功能、大小以及寿命上的进展都是基于起搏电极的发展上的。目前起搏电极的主要问题仍围绕在优良的电学特性以及组织相容性上。高阻抗、小直径激素释放绝缘电极已经成为当前起搏电极的主流。
研究目的:了解激素释放被动电极置入后的参数变化;评估其安全性和有效性。
方法:对我院2005年10月至2008年4月间91例植入起搏器患者的三种被动起搏电极进行随访,其中心房被动电极83根,心室被动电极85根。回顾性分析置入当时、术后3月和1年的电极感知与起搏阈值,评价其动态变化。
结果:同置入时比,术后3月三种电极心房起搏阈值均无统计学变化(P＞0.05);Biotronik电极心房感知由3.70±1.46 mV降至2.44±0.30 mV(P=0.001),Ela及Medtronic电极心房感知无统计学变化(P＞0.05);Biotronik心室电极起搏阈值由0.35±0.13 V升至0.17±0.23 V(P=0.003),Ela心室电极起搏阈值由0.58±0.24 V升至0.89±0.25 V(P＜0.001),Medtronic心室电极起搏阈值无统计学变化(P＞0.05);Biotronik心室电极感知由9.74±1.93 mV升至14.6±5.50 mV(P=0.015),Medtronic心室电极感知由11.29±4.38 mV升至15.42±5.43 mV(P=0.010),ela电极则无统计学变化(P＞0.05)。同置入时比,术后1年三类电极心房起搏阈值、心房感知、心室感知均无统计学变化(P＞0.05);Biotronik心室电极起搏阈值由0.44±0.21V升至0.63±0.28 V(P=0.035),Medtronic心室电极起搏阈值由0.48±0.26 V升至0.78±0.33V(P=0.031),ela电极则无统计学变化(P＞0.05)。1例患者出现术后电极脱位,再次手术后工作正常,未发现其它电极相关并发症。
结论:激素被动固定电极置入1年内能保持较低的起搏阈值及良好的感知度。
Background:Cardiac pacing lead is always the weakest aspect of the cardiac pacing therapy,the advances concerning the functionality,size,and longevity of cardiac pacemakers depend on concomitant advances in cardiac pacing leads.The current state of affairs of cardiac pacing leads are focusing on excellent electrical properties and histocompatibility.High impedance,small diameter and steroid-eluting leads are the common choices in clinical practice.
Objective:To evaluate and compare the steroid-eluting leads from different companies implanted in the past two years at Peking Union Medical College Hospital.
Method:Three different brands of steroid-eluting leads were randomly selected and implanted in 91 patients from Nov,2005 to Apr,2008,which include 83 atrial leads and 85 ventricular leads.Patients were followed at 3 and 12 months after implantation.Pacing and sensing thresholds and lead impedance were measured at the time of implantation and each follow-up.All the records were analyzed retrospectively and compared.
Results:At the first 3 months follow-up after implantation,atrial pacing thresholds revealed no significant difference(P＞0.05) in all brands of leads, compared to the records at the time of implantation.Biotronik atrial sensing thresholds reduced from 3.70±1.46 mV to 2.44±0.30 mV(P=0.001),while Ela and Medtronic showed no significant differences(P＞0.05).Biotronik ventricular pacing thresholds risen from 0.35±0.13 V to 0.17±0.23 V(P=0.003),Ela ventricular pacing thresholds risen from 0.58±0.24 V to 0.89±0.25 V (P＜0.001),but Medtronic revealed no significant differences(P＞0.05). Biontronik ventricular sensing thresholds risen from 9.74±1.93 mV to 14.6± 5.50 mV(P=0.015),Medtronic ventricular sensing thresholds risen from 11.29±4.38 mV to 15.42±5.43 mV(P=0.010),however,Ela remains no change statistically(P＞0.05).Compared to the records at the time of implantation,all the leads showed no significant difference in atrial pacing and sensing thresholds as well as ventricular sensing thresholds 12 months after implantation(P＞0.05).Biotronik ventricular pacing thresholds risen from 0.44±0.21V to 0.63±0.28 V(P=0.035),Medtronic ventricular pacing thresholds risen from 0.48±0.26 V to 0.78±0.33V(P=0.031),while Ela revealed no significant changes(P＞0.05).One patient suffered from lead dislocation but no other complications were identified during the follow-up.
Conclusion:The three different kinds of steroid-eluting leads evaluated in this study revealed stable parameter variation with a reliable clinical effect.
研究目的:了解激素释放被动电极置入后的参数变化;评估其安全性和有效性。
方法:对我院2005年10月至2008年4月间91例植入起搏器患者的三种被动起搏电极进行随访,其中心房被动电极83根,心室被动电极85根。回顾性分析置入当时、术后3月和1年的电极感知与起搏阈值,评价其动态变化。
结果:同置入时比,术后3月三种电极心房起搏阈值均无统计学变化(P＞0.05);Biotronik电极心房感知由3.70±1.46 mV降至2.44±0.30 mV(P=0.001),Ela及Medtronic电极心房感知无统计学变化(P＞0.05);Biotronik心室电极起搏阈值由0.35±0.13 V升至0.17±0.23 V(P=0.003),Ela心室电极起搏阈值由0.58±0.24 V升至0.89±0.25 V(P＜0.001),Medtronic心室电极起搏阈值无统计学变化(P＞0.05);Biotronik心室电极感知由9.74±1.93 mV升至14.6±5.50 mV(P=0.015),Medtronic心室电极感知由11.29±4.38 mV升至15.42±5.43 mV(P=0.010),ela电极则无统计学变化(P＞0.05)。同置入时比,术后1年三类电极心房起搏阈值、心房感知、心室感知均无统计学变化(P＞0.05);Biotronik心室电极起搏阈值由0.44±0.21V升至0.63±0.28 V(P=0.035),Medtronic心室电极起搏阈值由0.48±0.26 V升至0.78±0.33V(P=0.031),ela电极则无统计学变化(P＞0.05)。1例患者出现术后电极脱位,再次手术后工作正常,未发现其它电极相关并发症。
结论:激素被动固定电极置入1年内能保持较低的起搏阈值及良好的感知度。
Background:Cardiac pacing lead is always the weakest aspect of the cardiac pacing therapy,the advances concerning the functionality,size,and longevity of cardiac pacemakers depend on concomitant advances in cardiac pacing leads.The current state of affairs of cardiac pacing leads are focusing on excellent electrical properties and histocompatibility.High impedance,small diameter and steroid-eluting leads are the common choices in clinical practice.
Objective:To evaluate and compare the steroid-eluting leads from different companies implanted in the past two years at Peking Union Medical College Hospital.
Method:Three different brands of steroid-eluting leads were randomly selected and implanted in 91 patients from Nov,2005 to Apr,2008,which include 83 atrial leads and 85 ventricular leads.Patients were followed at 3 and 12 months after implantation.Pacing and sensing thresholds and lead impedance were measured at the time of implantation and each follow-up.All the records were analyzed retrospectively and compared.
Results:At the first 3 months follow-up after implantation,atrial pacing thresholds revealed no significant difference(P＞0.05) in all brands of leads, compared to the records at the time of implantation.Biotronik atrial sensing thresholds reduced from 3.70±1.46 mV to 2.44±0.30 mV(P=0.001),while Ela and Medtronic showed no significant differences(P＞0.05).Biotronik ventricular pacing thresholds risen from 0.35±0.13 V to 0.17±0.23 V(P=0.003),Ela ventricular pacing thresholds risen from 0.58±0.24 V to 0.89±0.25 V (P＜0.001),but Medtronic revealed no significant differences(P＞0.05). Biontronik ventricular sensing thresholds risen from 9.74±1.93 mV to 14.6± 5.50 mV(P=0.015),Medtronic ventricular sensing thresholds risen from 11.29±4.38 mV to 15.42±5.43 mV(P=0.010),however,Ela remains no change statistically(P＞0.05).Compared to the records at the time of implantation,all the leads showed no significant difference in atrial pacing and sensing thresholds as well as ventricular sensing thresholds 12 months after implantation(P＞0.05).Biotronik ventricular pacing thresholds risen from 0.44±0.21V to 0.63±0.28 V(P=0.035),Medtronic ventricular pacing thresholds risen from 0.48±0.26 V to 0.78±0.33V(P=0.031),while Ela revealed no significant changes(P＞0.05).One patient suffered from lead dislocation but no other complications were identified during the follow-up.
Conclusion:The three different kinds of steroid-eluting leads evaluated in this study revealed stable parameter variation with a reliable clinical effect.
引文
1. George H. Crossley MD. Cardiac Pacing Leads. Cardiology Clinics -Volume 18, Issue 1 (February 2000).
2. Irnich W: The fundamental law of electrostimulation and its application to defibrillation. Pacing Clin Electrophysiol 13:1433-1447.
3. Gillis AM, Rothschild JM, Hillier K, et al: A randomized comparison of a bipolar steroid-eluting electrode and a bipolar microporous platinum electrode: Implications for long term programming. Pacing Clin Electrophysiol 16:964-970,1993.
4. Schaldach M, Hubman M, Weikl A, et, al. Sputter-deposited TiN electrode coating for superior sensing and pacing performance. PACE 1990;13:1891-1895.
5. Moracchini PV, Cornacchia D, Bernasconi M, et al: High impedance low energy pacing leads: Long-term results with a very small surface area steroid-eluting lead compared to three conventional electrodes. Pacing Clin Electrophysiol 22:326-334, 1999。
6. Beanlands D, Akyurekli Y, Keon W: Prednisone in the management of exit block. In Meere C (ed): Proceedings of the Sixth World Symposium on Cardiac Pacing. Montreal,NASPE, 1979.
7. Hua W, Mond HG, Strathmore N: Chronic steroid-eluting lead performance: A comparison of atrial and ventricular pacing. Pacing Clin Electrophysiol 20:17-24, 1997.
8. Ben-zurUM, Platt SB, Gross JN, et al. Direct and telemetered lead impedence.PACE,1994,17:2004.
9. Ellenbogen KA, Hellkamp AS, Wilkoff BL, et al. Complications arising after implantation of DDD pacemakers: the MOST experience. Am J Cardiol 2003; 92: 740 - 41.
1.George H.Crossley MD.Cardiac Pacing Leads.Cardiology Clinics-Volume 18,Issue 1(February 2000).
2.British Standard.Specification for low profile connectors(IS-1) for implantable pacemakers.British Standards Institution(1993).Geneva:International Organization for Standardization,1993.
3.Furman S.Connectors.(Abstr.) PACE Pacing Clin Electrophysiol 1990,13:567.
4. Dolezel B, Adamirova L, Naprstek Z, et al: In vivo degradation of polymers:I. Change of mechanical properties in polyethylene pacemaker lead insulations during longterm implantation in the human body. Biomaterials 10:96-100,1989.
5. Dolezel B, Adamirova L, Vondracek P, et al: In vivo degradation of polymers: II. Change of mechanical properties and cross-link density in silicone rubber pacemaker lead insulations during long-term implantation in the human body. Biomaterials 10:387-392,1989.
6. Furman S: Basic concepts. In Furman S, Hayes DL, Holmes DRJ (eds): A Practice of Cardiac Pacing, ed 3. Mount Kisco, NY, Futura, 1993, pp 29-88.
7. Stokes KB: The biostability of polyurethane leads. In Barold SS (ed):Modern Cardiac Pacing. Mount Kisco, NY, Futura, 1985, pp 173-198.
8. Phillips RE, Smith MC, Thoma RJ: Biomedical applications of polyurethanes: Implications of failure mechanisms. J Biomater Appl 3:207-227, 1988.
9. Stokes K, McVenes R, Anderson JM: Polyurethane elastomer biostability. J Biomater Appl 9:321-354, 1995.
10.Chardack W, Gage A, Greatbatch W. Correction of complete heart block by a self-contained and subcutaneously implanted pacemaker. J Thorac Candiovas Surg 1961,42:814-820.
11 .Tang C, Yeung-Lai-Wah JA, Qi A,et al. Initial experience with a co-radial bipolar pacing lead. PACE 1997;20:1800-1807.
12.Schaldach M, Hubman M, Weikl A, et, al. Sputter-deposited TiN electrode coating for superior sensing and pacing performance. PACE 1990;13:1891-1895.
13.Mond H, Stokes KB. The electrode-tissue interface: the revolutionary role of steroid elution. PACE 1992;15:95-107.
14.Beanlands D, Akyurekli Y, Keon W: Prednisone in the management of exit block. In Meere C (ed): Proceedings of the Sixth World Symposium on Cardiac Pacing. Montreal,NASPE, 1979.
15. Gillis AM, Rothschild JM, Hillier K, et al: A randomized comparison of a bipolar steroid-eluting electrode and a bipolar microporous platinum electrode: Implications for long term programming. Pacing Clin Electrophysiol 16:964-970,1993.
16.Hua W, Mond HG, Strathmore N: Chronic steroid-eluting lead performance:A comparison of atrial and ventricular pacing. Pacing Clin Electrophysiol 20:17-24, 1997.
17.Pirzada FA, Moschitto LJ, Diorio D: Clinical experience with steroid-eluting unipolar electrodes. Pacing Clin Electrophysiol 11:1739-1744, 1988.
18.Crossley GH, Brinker JA, Reynolds D, et al: Steroid elution improves the stimulation threshold in an active-fixation atrial permanent pacing lead: A randomized, controlled study. Model 4068 Investigators. Circulation 92:2935-2939, 1995.
19.Guerola M, Lingren U, Hagel p. One year clinical evauation of new porous titanium nitride electrodes coated with steroid and a layer of ion-exchange membrane. Eur J Cardiac Pacing Electrophysiol 1992;2:A90.
20.Moracchini PV, Comacchia D, Bernasconi M, et al: High impedance low energy pacing leads: Long-term results with a very small surface area steroid-eluting lead compared to three conventional electrodes. Pacing Clin Electrophysiol 22:326-334, 1999。
21.Ellenbogen KA, Wood MA, Gilligan DM, et al: Steroid eluting high impedance pacing leads decrease short- and long-term current drain:Results from a multicenter clinical trial. Capsure Z investigators. Pacing Clin Electrophysiol 22:39-48, 1999.
22. Johnson WB, Vogel I, Greene TO, et al: Comprehensive one-year follow up of the medtronic 5034 lead: Notable early lead dislodgement [abstr]. Pacing Clin Electrophysiology 21:874, 1998。
23.McQuillion S: Selute Picotip ventricular pacing lead, clinical report. St. Paul,Minnesota, Guidant, 1997。
24.Mond H, Sloman G. The small-tined pacemaker lead: A dislodgement.PACE 1980;3:171-177.
25. Greco OT, Ardito RV, Martinelli M, et al. Sweet Tip Rx:A new type of atrial active fixation lead. (abstract)PACE 1997;20:1642.
26.Crossley GH, Tonder L, Freedman RA, et al: Active fixation leads have more perforations than passive fixation leads and a similar dislodgment rate [abstr]. Circulation 94:677, 1996.
27. McAlister FA, Ezekowitz J, et,al. Cardiac resynchronization therapy and implantable cardiac defibrillators in left ventricular systolic dysfunction. Evid Rep Technol Assess (Full Rep). 2007 Jun;(152):1-199. Review.
28. Kay GN, Brinker JA, Kawanishi DT, et al: The risks of spontaneous injury and extraction of an active fixation pacemaker lead: Report of the Accufix Multicenter Clinical Study and World-Wide Registry. Circulation 100:2344-2352, 1999.
29.Magishi K, Izumi Y.et.al. Removal of infected pacemaker leads under extracorporeal circulation Kyobu Geka. 2007 Nov;60(12): 1074-8.
30. Irnich W: The fundamental law of electrostimulation and its application to defbrillation. Pacing Clin Electrophysiol 13:1433-1447.
31.Ben—zur UM, Platt SB, Gross JN, et al. Direct and telemetered lead impedence.PACE,1994,17:2004.
32.Ellenbogen KA, Hellkamp AS, Wilkoff BL, et al. Complications arising after implantation of DDD pacemakers: the MOST experience. Am J Cardiol 2003;92:740-41.
2. Irnich W: The fundamental law of electrostimulation and its application to defibrillation. Pacing Clin Electrophysiol 13:1433-1447.
3. Gillis AM, Rothschild JM, Hillier K, et al: A randomized comparison of a bipolar steroid-eluting electrode and a bipolar microporous platinum electrode: Implications for long term programming. Pacing Clin Electrophysiol 16:964-970,1993.
4. Schaldach M, Hubman M, Weikl A, et, al. Sputter-deposited TiN electrode coating for superior sensing and pacing performance. PACE 1990;13:1891-1895.
5. Moracchini PV, Cornacchia D, Bernasconi M, et al: High impedance low energy pacing leads: Long-term results with a very small surface area steroid-eluting lead compared to three conventional electrodes. Pacing Clin Electrophysiol 22:326-334, 1999。
6. Beanlands D, Akyurekli Y, Keon W: Prednisone in the management of exit block. In Meere C (ed): Proceedings of the Sixth World Symposium on Cardiac Pacing. Montreal,NASPE, 1979.
7. Hua W, Mond HG, Strathmore N: Chronic steroid-eluting lead performance: A comparison of atrial and ventricular pacing. Pacing Clin Electrophysiol 20:17-24, 1997.
8. Ben-zurUM, Platt SB, Gross JN, et al. Direct and telemetered lead impedence.PACE,1994,17:2004.
9. Ellenbogen KA, Hellkamp AS, Wilkoff BL, et al. Complications arising after implantation of DDD pacemakers: the MOST experience. Am J Cardiol 2003; 92: 740 - 41.
1.George H.Crossley MD.Cardiac Pacing Leads.Cardiology Clinics-Volume 18,Issue 1(February 2000).
2.British Standard.Specification for low profile connectors(IS-1) for implantable pacemakers.British Standards Institution(1993).Geneva:International Organization for Standardization,1993.
3.Furman S.Connectors.(Abstr.) PACE Pacing Clin Electrophysiol 1990,13:567.
4. Dolezel B, Adamirova L, Naprstek Z, et al: In vivo degradation of polymers:I. Change of mechanical properties in polyethylene pacemaker lead insulations during longterm implantation in the human body. Biomaterials 10:96-100,1989.
5. Dolezel B, Adamirova L, Vondracek P, et al: In vivo degradation of polymers: II. Change of mechanical properties and cross-link density in silicone rubber pacemaker lead insulations during long-term implantation in the human body. Biomaterials 10:387-392,1989.
6. Furman S: Basic concepts. In Furman S, Hayes DL, Holmes DRJ (eds): A Practice of Cardiac Pacing, ed 3. Mount Kisco, NY, Futura, 1993, pp 29-88.
7. Stokes KB: The biostability of polyurethane leads. In Barold SS (ed):Modern Cardiac Pacing. Mount Kisco, NY, Futura, 1985, pp 173-198.
8. Phillips RE, Smith MC, Thoma RJ: Biomedical applications of polyurethanes: Implications of failure mechanisms. J Biomater Appl 3:207-227, 1988.
9. Stokes K, McVenes R, Anderson JM: Polyurethane elastomer biostability. J Biomater Appl 9:321-354, 1995.
10.Chardack W, Gage A, Greatbatch W. Correction of complete heart block by a self-contained and subcutaneously implanted pacemaker. J Thorac Candiovas Surg 1961,42:814-820.
11 .Tang C, Yeung-Lai-Wah JA, Qi A,et al. Initial experience with a co-radial bipolar pacing lead. PACE 1997;20:1800-1807.
12.Schaldach M, Hubman M, Weikl A, et, al. Sputter-deposited TiN electrode coating for superior sensing and pacing performance. PACE 1990;13:1891-1895.
13.Mond H, Stokes KB. The electrode-tissue interface: the revolutionary role of steroid elution. PACE 1992;15:95-107.
14.Beanlands D, Akyurekli Y, Keon W: Prednisone in the management of exit block. In Meere C (ed): Proceedings of the Sixth World Symposium on Cardiac Pacing. Montreal,NASPE, 1979.
15. Gillis AM, Rothschild JM, Hillier K, et al: A randomized comparison of a bipolar steroid-eluting electrode and a bipolar microporous platinum electrode: Implications for long term programming. Pacing Clin Electrophysiol 16:964-970,1993.
16.Hua W, Mond HG, Strathmore N: Chronic steroid-eluting lead performance:A comparison of atrial and ventricular pacing. Pacing Clin Electrophysiol 20:17-24, 1997.
17.Pirzada FA, Moschitto LJ, Diorio D: Clinical experience with steroid-eluting unipolar electrodes. Pacing Clin Electrophysiol 11:1739-1744, 1988.
18.Crossley GH, Brinker JA, Reynolds D, et al: Steroid elution improves the stimulation threshold in an active-fixation atrial permanent pacing lead: A randomized, controlled study. Model 4068 Investigators. Circulation 92:2935-2939, 1995.
19.Guerola M, Lingren U, Hagel p. One year clinical evauation of new porous titanium nitride electrodes coated with steroid and a layer of ion-exchange membrane. Eur J Cardiac Pacing Electrophysiol 1992;2:A90.
20.Moracchini PV, Comacchia D, Bernasconi M, et al: High impedance low energy pacing leads: Long-term results with a very small surface area steroid-eluting lead compared to three conventional electrodes. Pacing Clin Electrophysiol 22:326-334, 1999。
21.Ellenbogen KA, Wood MA, Gilligan DM, et al: Steroid eluting high impedance pacing leads decrease short- and long-term current drain:Results from a multicenter clinical trial. Capsure Z investigators. Pacing Clin Electrophysiol 22:39-48, 1999.
22. Johnson WB, Vogel I, Greene TO, et al: Comprehensive one-year follow up of the medtronic 5034 lead: Notable early lead dislodgement [abstr]. Pacing Clin Electrophysiology 21:874, 1998。
23.McQuillion S: Selute Picotip ventricular pacing lead, clinical report. St. Paul,Minnesota, Guidant, 1997。
24.Mond H, Sloman G. The small-tined pacemaker lead: A dislodgement.PACE 1980;3:171-177.
25. Greco OT, Ardito RV, Martinelli M, et al. Sweet Tip Rx:A new type of atrial active fixation lead. (abstract)PACE 1997;20:1642.
26.Crossley GH, Tonder L, Freedman RA, et al: Active fixation leads have more perforations than passive fixation leads and a similar dislodgment rate [abstr]. Circulation 94:677, 1996.
27. McAlister FA, Ezekowitz J, et,al. Cardiac resynchronization therapy and implantable cardiac defibrillators in left ventricular systolic dysfunction. Evid Rep Technol Assess (Full Rep). 2007 Jun;(152):1-199. Review.
28. Kay GN, Brinker JA, Kawanishi DT, et al: The risks of spontaneous injury and extraction of an active fixation pacemaker lead: Report of the Accufix Multicenter Clinical Study and World-Wide Registry. Circulation 100:2344-2352, 1999.
29.Magishi K, Izumi Y.et.al. Removal of infected pacemaker leads under extracorporeal circulation Kyobu Geka. 2007 Nov;60(12): 1074-8.
30. Irnich W: The fundamental law of electrostimulation and its application to defbrillation. Pacing Clin Electrophysiol 13:1433-1447.
31.Ben—zur UM, Platt SB, Gross JN, et al. Direct and telemetered lead impedence.PACE,1994,17:2004.
32.Ellenbogen KA, Hellkamp AS, Wilkoff BL, et al. Complications arising after implantation of DDD pacemakers: the MOST experience. Am J Cardiol 2003;92:740-41.