Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort

Tracy A. Williams, Jacques W.M. Lenders, Paolo Mulatero, Jacopo Burrello, Marietta Rottenkolber, Christian Adolf, Fumitoshi Satoh, Laurence Amar, Marcus Quinkler, Jaap Deinum, Felix Beuschlein, Kanako K. Kitamoto, Uyen Pham, Ryo Morimoto, Hironobu Umakoshi, Aleksander Prejbisz, Tomaz Kocjan, Mitsuhide Naruse, Michael Stowasser, Tetsuo Nishikawa & 5 others William F. Young, Celso E. Gomez-Sanchez, John W. Funder, Martin Reincke, for the Primary Aldosteronism Surgery Outcome (PASO) investigators

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Background 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. Methods 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. Findings 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). Interpretation 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. Funding 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).

Original languageEnglish
Pages (from-to)689-699
Number of pages11
JournalThe Lancet Diabetes and Endocrinology
Volume5
Issue number9
DOIs
Publication statusPublished - 1 Sep 2017

Cite this

Williams, T. A., Lenders, J. W. M., Mulatero, P., Burrello, J., Rottenkolber, M., Adolf, C., ... for the Primary Aldosteronism Surgery Outcome (PASO) investigators (2017). Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort. The Lancet Diabetes and Endocrinology, 5(9), 689-699. https://doi.org/10.1016/S2213-8587(17)30135-3
Williams, Tracy A. ; Lenders, Jacques W.M. ; Mulatero, Paolo ; Burrello, Jacopo ; Rottenkolber, Marietta ; Adolf, Christian ; Satoh, Fumitoshi ; Amar, Laurence ; Quinkler, Marcus ; Deinum, Jaap ; Beuschlein, Felix ; Kitamoto, Kanako K. ; Pham, Uyen ; Morimoto, Ryo ; Umakoshi, Hironobu ; Prejbisz, Aleksander ; Kocjan, Tomaz ; Naruse, Mitsuhide ; Stowasser, Michael ; Nishikawa, Tetsuo ; Young, William F. ; Gomez-Sanchez, Celso E. ; Funder, John W. ; Reincke, Martin ; for the Primary Aldosteronism Surgery Outcome (PASO) investigators. / Outcomes after adrenalectomy for unilateral primary aldosteronism : an international consensus on outcome measures and analysis of remission rates in an international cohort. In: The Lancet Diabetes and Endocrinology. 2017 ; Vol. 5, No. 9. pp. 689-699.
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title = "Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort",
abstract = "Background 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. Methods 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. Findings 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). Interpretation 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. Funding European Research Council; European Union's Horizon 2020; Else Kr{\"o}ner-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).",
author = "Williams, {Tracy A.} and Lenders, {Jacques W.M.} and Paolo Mulatero and Jacopo Burrello and Marietta Rottenkolber and Christian Adolf and Fumitoshi Satoh and Laurence Amar and Marcus Quinkler and Jaap Deinum and Felix Beuschlein and Kitamoto, {Kanako K.} and Uyen Pham and Ryo Morimoto and Hironobu Umakoshi and Aleksander Prejbisz and Tomaz Kocjan and Mitsuhide Naruse and Michael Stowasser and Tetsuo Nishikawa and Young, {William F.} and Gomez-Sanchez, {Celso E.} and Funder, {John W.} and Martin Reincke and {for the Primary Aldosteronism Surgery Outcome (PASO) investigators}",
year = "2017",
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language = "English",
volume = "5",
pages = "689--699",
journal = "The Lancet Diabetes and Endocrinology",
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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, Gomez-Sanchez, CE, Funder, JW, Reincke, M & for the Primary Aldosteronism Surgery Outcome (PASO) investigators 2017, 'Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort' The Lancet Diabetes and Endocrinology, vol. 5, no. 9, pp. 689-699. https://doi.org/10.1016/S2213-8587(17)30135-3

Outcomes after adrenalectomy for unilateral primary aldosteronism : an international consensus on outcome measures and analysis of remission rates in an international cohort. / Williams, Tracy A.; Lenders, Jacques W.M.; Mulatero, Paolo; Burrello, Jacopo; Rottenkolber, Marietta; Adolf, Christian; Satoh, Fumitoshi; Amar, Laurence; Quinkler, Marcus; Deinum, Jaap; Beuschlein, Felix; Kitamoto, Kanako K.; Pham, Uyen; Morimoto, Ryo; Umakoshi, Hironobu; Prejbisz, Aleksander; Kocjan, Tomaz; Naruse, Mitsuhide; Stowasser, Michael; Nishikawa, Tetsuo; Young, William F.; Gomez-Sanchez, Celso E.; Funder, John W.; Reincke, Martin; for the Primary Aldosteronism Surgery Outcome (PASO) investigators.

In: The Lancet Diabetes and Endocrinology, Vol. 5, No. 9, 01.09.2017, p. 689-699.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Outcomes after adrenalectomy for unilateral primary aldosteronism

T2 - an international consensus on outcome measures and analysis of remission rates in an international cohort

AU - Williams, Tracy A.

AU - Lenders, Jacques W.M.

AU - Mulatero, Paolo

AU - Burrello, Jacopo

AU - Rottenkolber, Marietta

AU - Adolf, Christian

AU - Satoh, Fumitoshi

AU - Amar, Laurence

AU - Quinkler, Marcus

AU - Deinum, Jaap

AU - Beuschlein, Felix

AU - Kitamoto, Kanako K.

AU - Pham, Uyen

AU - Morimoto, Ryo

AU - Umakoshi, Hironobu

AU - Prejbisz, Aleksander

AU - Kocjan, Tomaz

AU - Naruse, Mitsuhide

AU - Stowasser, Michael

AU - Nishikawa, Tetsuo

AU - Young, William F.

AU - Gomez-Sanchez, Celso E.

AU - Funder, John W.

AU - Reincke, Martin

AU - for the Primary Aldosteronism Surgery Outcome (PASO) investigators

PY - 2017/9/1

Y1 - 2017/9/1

N2 - Background 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. Methods 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. Findings 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). Interpretation 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. Funding 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).

AB - Background 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. Methods 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. Findings 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). Interpretation 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. Funding 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).

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