| Objective:To observe the characteristics and follow-up parameters of domestic pacemaker REF3201,comparison with imported pacemaker Medtronic REDO 1,to explore the safety and effectiveness of REF3201,to provide basis for clinical application of domestic pacemaker.Methods:This study selected patients who were implanted with a buried permanent artificial heart dual-chamber pacemaker in the Department of Cardiology of the Sixth Affiliated Hospital of Kunming Medical University from June 2018 to June 2019,A total of 20 patients with domestic pacemakers REF3201 were selected as a research group,In addition,21 patients with Medtronic RED01 imported pacemaker as the control group.A complete follow-up record of patients with pacemaker implantation was established,and record the pacemaker parameters at 1,3,6,and 12 months after the pacemaker implantation,including pacing threshold,lead impedance,P/R wave amplitude,and close follow-up observation of postoperative complications including electrode dislocation,pacemaker bag infection,pacemaker bag hematoma,cardiac perforation,venous thrombosis,pacemaker syndrome,etc.,Comparing the clinical efficacy and safety between the two groups.Results:1.A total of 41 patients with permanent dual-chamber pacemaker implantation in the Sixth Affiliated Hospital of Kunming Medical University from June 2018 to June 2019 were selected in the study.All patients were implanted successfully and followed up regularly.2.The study group included 9 male patients(45%)and 11 female patients(55%),while the control group included 11 male(52.38%)and 10 female(47.62%).There was no significant difference in the percentages among males and females between the two groups(P=0.636).The age of the patients was 74(66.5,80.5)years old in the study group,while the age of the patients was 68(60.5,80.0)years old in the control group,and the difference was not statistical between the two groups(P=0.379).There was no significant difference in arrhythmias between the two groups(P=0.427).3.Comparison of pacing parameter(the polarity of electrode was bipolar during the test):There was no statistical difference in atrial and ventricular pacing thresholds during intraoperative and at 1,3,6,12 months postoperatively between the study group and the control group(P>0.05).The pacing thresholds at 1,3,6,and 12 months postoperatively in both groups were obviously decreased than intraoperative,and the difference was statistical in both groups(P<0.05).The pacing thresholds tended to remain stable at 1 months postoperatively in both group,and the difference was statistical between 1 months postoperatively and 3,6,12 months postoperatively(P>0.05).There was no statistical difference in atrial and ventricular impedance during intraoperative and at 1,3,6,12 months postoperatively between the study group and the control group(P>0.05).And the within-group comparisons showed that there was no statistical difference in atrial and ventricular impedance between intraoperative and 1,3,6,12 months postoperatively in both groups(P>0.05).There was no statistical difference in the amplitudes of P waves or R waves during intraoperative and at 1,3,6,12 months postoperatively between the study group and the control group(P>0.05).4.Comparison of pacemaker volume and expected service life,the pacemakers ’ size,volume and weight in the study group were significantly smaller than those in the control group.Expected remaining life:the expected remaining life of the study group was 9.40 ± 1.27 years at 6 months postoperatively,while the control group’s was 9.61 ± 1.32 years,the difference was not statistical between the two groups(P>0.05).The expected remaining life of the study group was 9.00±1.02 years at 12 months postoperatively,while the control group’s was 9.28 ± 1.00 years,the difference was not statistical as well(P>0.05).5.Comparison of pacemaker cost:the total price of pacemaker and electrodes was 27200 yuan in the study group,while that was 37429.35 yuan in the control group;the average hospitalization cost was 34853.11 ± 1915.84 yuan in the study group,while the control group’s was 44801.69±1595.88 yuan.Both the total price of pacemaker and electrodes and the average hospitalization cost were significantly lower in the study group than that in the control group,with a statistically significant difference(P<0.05).6.There were no postoperative complications such as the power of pacemaker battery was exhausted in advance,pacemaker bag infection and ulceration,increased pacing threshold,poor perception,electrode dislocation and fracture,pacemaker syndrome,etc or failure about the pacemaker itself in both groups.Conclusion:1.After 12 months of follow-up,the parameters(pacing threshold,impedance,P/R wave amplitude)of domestic pacemaker REF3201 are similar to MedtronicRED01,which are stable and reliable.2.The safety of domestic pacemakers is the same as imported pacemakers,there were no postoperative complications such as the power of pacemaker battery was exhausted in advance,pacemaker bag infection and ulceration,increased pacing threshold,poor perception,electrode dislocation and fracture,pacemaker bag infection,pacemaker bag rupture,pacemaker syndrome,complications and failure of the pacemaker itself,safe and reliable.3.The domestic pacemaker has smaleer and cheaper,which can be used as one of the options for clinical application. |
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