Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort.
Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort.
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单侧原发性醛固酮主义肾上腺切除术后的结局：关于结果测量和分析国际队列中缓解率的国际共识。
DOI：
10.1016/s2213-8587(17)30135-3
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发表时间：
2017-09
期刊：
影响因子：
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通讯作者：
Primary Aldosteronism Surgery Outcome (PASO) investigators
中科院分区：
文献类型：
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作者：
Williams TA;Lenders JWM;Mulatero P;Burrello J;Rottenkolber M;Adolf C;Satoh F;Amar L;Quinkler M;Deinum J;Beuschlein F;Kitamoto KK;Pham U;Morimoto R;Umakoshi H;Prejbisz A;Kocjan T;Naruse M;Stowasser M;Nishikawa T;Young WF Jr;Gomez-Sanchez CE;Funder JW;Reincke M;Primary Aldosteronism Surgery Outcome (PASO) investigators
虽然单侧原发性醛固酮增多症是高血压最常见的手术可纠正原因，但没有标准的标准来分类手术结果。我们的目标是为单侧原发性醛固酮增多症的临床和生化结果以及肾上腺切除术的随访建立共识标准，并将这些标准应用于国际队列，以分析缓解的频率和确定手术前成功结果的决定因素。原发性醛固酮增多症手术结局(PASO)研究是一个国际项目，旨在为单侧原发性醛固酮增多症肾上腺切除术的疗效和随访制定共识标准。一个由来自28个中心的31名专家组成的国际小组，其中包括6名内分泌外科医生，使用德尔菲法达成共识。然后，我们回顾分析了来自9个国家的12个转诊中心，通过肾上腺静脉采样确诊为单侧原发性醛固酮增多症的患者接受了肾上腺全切除术的前瞻性队列的随访数据，以评估结果。在标准化标准的基础上，我们根据共识确定获得完全、部分或无临床和生化成功的患者的比例。然后，我们使用Logistic回归分析来确定与临床和生化结果相关的术前因素。根据血压、抗高血压药物的使用、血钾和醛固酮浓度以及血浆肾素浓度或活性，就六种结果(临床和生化结果完全成功、部分成功和无成功)的标准达成了共识。还就关于后续评估时间的两项建议达成了协商一致。在国际队列分析中，我们分析了1994至2015年间招募的705名患者的临床数据，其中699人也有生化数据。在705名患者中，259名(37%)获得了完全临床成功，差异很大(17-62)，另外334名(47%，范围35-66)获得了部分临床成功；699名患者中有656名(94%，83-100)获得了完全生化成功。女性患者临床完全成功的可能性(优势比[OR]2·25，95%可信区间1·40~3·62；P=0·001)和临床获益(完全+部分临床成功；OR 2·89，1·49~5·59；P=0·002)均高于男性患者。年轻患者临床完全成功的可能性(OR为0.95，每多一年为0.93-0.98；P<；为0.001)和临床获益(OR为0.95，每多一年为0.92-0.98；P=0.004)较高。较高的术前用药水平与较低的临床完全成功水平相关(OR0.80每单位增加，0.70-0.90；P<；0.001)。这些标准化的结果标准与评估个别患者的手术治疗成功有关，并将允许在未来的研究中比较结果数据。我们的国际队列的不同基线临床特征导致了临床结果的广泛差异。大多数患者从肾上腺切除术中获得临床益处，年轻患者和女性患者更有可能获得良好的手术结果。尽管如此，仍应对符合美国内分泌学会指南标准的每个人进行原发性醛固酮增多症的筛查，因为生化方面的成功而不是临床上的成功本身在临床上是重要的，老年女性和男性也可以获得术后的临床益处。以下机构派代表出席了会议：欧洲研究理事会；欧洲联盟地平线2020；Else Kröner-Fresenius Stiftung；荷兰卫生研究与发展组织-医学科学；日本厚生劳动省；斯洛文尼亚卫生部；美国国立卫生研究院；以及CONICYT-Fondecyt(智利)。
Although unilateral primary aldosteronism is the most common surgically correctable cause of hypertension, no standard criteria exist to classify surgical outcomes. We aimed to create consensus criteria for clinical and biochemical outcomes and follow-up of adrenalectomy for unilateral primary aldosteronism and apply these criteria to an international cohort to analyse the frequency of remission and identify preoperative determinants of successful outcome. The Primary Aldosteronism Surgical Outcome (PASO) study was an international project to develop consensus criteria for outcomes and follow-up of adrenalectomy for unilateral primary aldosteronism. An international panel of 31 experts from 28 centres, including six endocrine surgeons, used the Delphi method to reach consensus. We then retrospectively analysed follow-up data from prospective cohorts for outcome assessment of patients diagnosed with unilateral primary aldosteronism by adrenal venous sampling who had undergone a total adrenalectomy, consecutively included from 12 referral centres in nine countries. On the basis of standardised criteria, we determined the proportions of patients achieving complete, partial, or absent clinical and biochemical success in accordance with the consensus. We then used logistic regression analyses to identify preoperative factors associated with clinical and biochemical outcomes. Consensus was reached for criteria for six outcomes (complete, partial, and absent success of clinical and biochemical outcomes) based on blood pressure, use of antihypertensive drugs, plasma potassium and aldosterone concentrations, and plasma renin concentrations or activities. Consensus was also reached for two recommendations for the timing of follow-up assessment. For the international cohort analysis, we analysed clinical data from 705 patients recruited between 1994 and 2015, of whom 699 also had biochemical data. Complete clinical success was achieved in 259 (37%) of 705 patients, with a wide variance (range 17–62), and partial clinical success in an additional 334 (47%, range 35–66); complete biochemical success was seen in 656 (94%, 83–100) of 699 patients. Female patients had a higher likelihood of complete clinical success (odds ratio [OR] 2·25, 95% CI 1·40–3·62; p=0·001) and clinical benefit (complete plus partial clinical success; OR 2·89, 1·49–5·59; p=0·002) than male patients. Younger patients had a higher likelihood of complete clinical success (OR 0·95 per extra year, 0·93–0·98; p<0·001) and clinical benefit (OR 0·95 per extra year, 0·92–0·98; p=0·004). Higher levels of preoperative medication were associated with lower levels of complete clinical success (OR 0·80 per unit increase, 0·70–0·90; p<0·001). These standardised outcome criteria are relevant for the assessment of the success of surgical treatment in individual patients and will allow the comparison of outcome data in future studies. The variable baseline clinical characteristics of our international cohort contributed to wide variation in clinical outcomes. Most patients derive clinical benefit from adrenalectomy, with younger patients and female patients more likely to have a favourable surgical outcome. Screening for primary aldosteronism should nonetheless be done in every individual fulfilling US Endocrine Society guideline criteria because biochemical success without clinical success is by itself clinically important and older women and men can also derive post-operative clinical benefit. European Research Council; European Union’s Horizon 2020; Else Kröner-Fresenius Stiftung; Netherlands Organisation for Health Research and Development–Medical Sciences; Japanese Ministry of Health, Labour and Welfare; Ministry of Health, Slovenia; US National Institutes of Health; and CONICYT-FONDECYT (Chile).