| Objective:Primary aldosteronism accounts for approximately 20% of resistant hypertension,Aldosterone-producing adenoma is the most common unilateral disease of primary aldosteronism,also known as aldosterone-producing adenoma type of primary aldosteronism.It is expected to achieve a curative effect after surgical treatment,but the postoperative biochemical index response rate is 83-100%,the clinical response rate is only 17-62%.In some patients with unilateral aldosterone-producing adenoma,the control of blood pressure is still not satisfactory after adrenalectomy.The purpose of this study was to investigate the safety and efficacy of RDN from the adventitia of renal artery plus adrenalectomy to treat patients with resistant hypertension complicated by unilateral aldosterone-producing adenoma.Method:From January 2016 to March 2018,a total of 60 patients with refractory hypertension and unilateral aldosterone-producing adenoma who were admitted to the Henan Provincial People's Hospital were randomly divided into 1:1 ratios.One group underwent RDN from the adventitia of the renal artery plus adrenalectomy with the help of laparoscopic(RDN group,n=30),One group underwent adrenalectomyalone with the help of laparoscopic(Control group,n=30).Patients in the two groups were all followed up for 12 months,the primary efficacy endpoint was the change in 24-h mean ambulatory systolic blood pressure(SBP)from baseline to 12 months.Other indicators include the 24-hour mean diastolic blood pressure(DBP),office SBP,office DBP,the type of antihypertensive medication,plasma aldosterone concentration,plasma renin activity,and plasma aldosterone renin ratio activity ratio(ARR),serum potassium levels,estimated glomerular filtration rate(e GFR),and the incidence of adverse events within 12 months.Results:1.There were no significant differences in general data before surgery between the two groups,including age,sex ratio,body mass index(BMI),smoking history ratio,duration of hypertension,family history of hypertension,and prevalence of type 2 diabetes,and there were all no statistical differences.Also,there were no significant differences in the average plasma aldosterone concentration,plasma renin activity,serum potassium,e GFR,24-hour average SBP,24-hour average DBP,and average office SBP and office DBP in the two groups,and there was no statistical difference between the two groups(P>0.05).2.Both groups of patients were followed up to 12 months after surgery.A total of 2 patients in the adventitia-RDN group were lost to follow-up,resulting in 28 patients being followed up 12 months after surgery.One patient in the control group withdrew from the clinical study after surgery,one patient was lost to follow-up,and 28 patients were followed up 12 months after surgery.After follow-up to 12 months,the mean 24-hours SBP in the adventitia-RDN group was(127.2 ± 10.7)mm Hg,which was(-20.7±15.2)mm Hg lower than that in the baseline,and the mean 24-hours SBP in the control group was(134.1±11.2)mm Hg,which was(-11.9±11.1)mm Hg lower than that before surgery.And there was a statistically significant difference of the reduction of 24-hours average SBP in patients between the two groups[(-20.7±15.2)VS(-11.9±11.1)mm Hg,P <0.05)].3.In the 12 months after surgery,the blood pressure of the adventiti-RDN group returned to normal and 16 people did not take any antihypertensive medication at all,accounting for 57.1%,and 12 people needed one antihypertensive medication to control blood pressure normally,accounting for total42.9% of patients.In the control group,blood pressure returned to normal.There were 13 patients who did not take any antihypertensive medication at all,accounting for 46.4% of the total patients,and 15 patients who required antihypertensive medications to control blood pressure normally,accounting for 53.6% of the total patients.Among them,10 people took one antihypertensive medication,accounting for 5.7% of the total patients,and 3 people took two antihypertensive medications to control blood pressure normally,accounting for 10.7% of the total patients.There were 2 patients needed to take three antihypertensive medications still,accounting for 7.2% of the total patients.4.At 12 months after surgery,plasma renin activity,plasma aldosterone level,and blood potassium of the adventitial RDN group and the control group were significantly improved compared with the baseline levels of the same group,and the differences were statistically significant(P <0.001);However,there were no significant differences in the plasma renin activity,e GFR,and blood potassium levels between the adventitial-RDN group and the control group(P> 0.05);After 12 months,the median plasma aldosterone concentration in the adventitia RDN group was significantly lower than that in the control group,but there was no significant difference between the groups [95.0(70.0-128.2)VS 141.0(94.3-187.0)pg/ml,P = 0.053].5.In the two groups,the eGFR did not decrease significantly from baseline at 12 months after operation,and there was no significant difference between the groups(P> 0.05).During the 12-month follow-up,there were no changes in the adventitia-RDN group and the control group.And there were nocomplications occurred during the follow-up.Conclusion1.Unilateral laparoscopic adrenalectomy plus RDN from the adventitia of the renal artery is more effective than unilateral laparoscopic adrenalectomy alone for treating resistant hypertension complicated by unilateral aldosterone-producing adenoma.2.Unilateral laparoscopic adrenalectomy plus RDN from the adventitia of the renal artery is safe. |
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