Lenders, J. W. M.

Reincke, M.

Williams, T. A.

English

Williams, T.A.

Lenders, J.W.M.

NARCIS 

Assessing outcomes after adrenalectomy for unilateral primary aldosteronism

Institutional Research Information System University of Turin

14 December 2021AperTO - Archivio Istituzionale Open Access dell'Università di TorinoOriginal Citation:Assessing outcomes after adrenalectomy for unilateral primary aldosteronismPublished version:DOI:10.1016/j.surg.2019.06.027Terms of use:Open Access(Article begins on next page)Anyone can freely access the full text of works made available as "Open Access". Works made available under aCreative Commons license can be used according to the terms and conditions of said license. Use of all other worksrequires consent of the right holder (author or publisher) if not exempted from copyright protection by the applicable law.Availability:This is the author's manuscriptThis version is available http://hdl.handle.net/2318/1717651 since 2019-11-25T23:46:21Z   1  Dear  Editor,  We  read  with  interest  the  article  “Clinical  outcomes  after  surgery  for  primary  aldosteronism:  evaluation  of  the  PASO-­‐investigators´consensus  criteria  within  a  worldwide  cohort  of  patients“  by  Vorselaars  and  collaegues.1  From  their  retrospective  study  the  authors  concluded  that  16%  of  their  patients  were  incorrectly  or  debatably  classified  using  the  criteria  of  the  PASO  consensus.2    The  authors  suggested  that  this  was  mainly  due  to  using  a  cut-­‐off  of  ≥20  mmHg  to  classify  a  clinically  relevant  change  in  systolic  blood  pressure.  In  addition,  the  authors  suggested  that  use  of  percentages  instead  of  absolute  values  in  change  of  antihypertensive  medication  (daily  defined  doses)  contributed  to  this  incorrect  classification.  We  would  like  to  clarify  a  number  of  points:  1.  The  use  of  office  blood  pressure  measurements  are  notorious  for  their  variability.  This  variability  may  even  be  exaggerated  in  the  study  because  blood  pressure  (as  main  outcome  parameter)  was  not  measured  in  a  standardized  way.  This  is  clearly  illustrated  by  the  fact  that  in  27%  of  the  patients  the  preoperative  blood  pressure  level  was  based  on  only  one  blood  pressure  value  and  this  was  increased  to  50%  of  patients  for  assessment  of  postoperative  blood  pressure.  The  reliability  and  accuracy  of  the  changes  in  blood  pressure  in  this  study  are  therefore  questionable.      2.  Related  to  the  previous  point,  a  cut-­‐off  change  in  systolic  blood  pressure  of  10  mmHg,  as  recommended  by  the  authors,  cannot  be  considered  sufficiently  robust  to  estimate  partial  clinical  success.  The  cut-­‐off  level  of  20  mmHg  was  selected  from  the  differences  between  blood  pressure  levels  that  define  blood  pressure  categories  of  hypertension3  and  used  by  the  PASO  group  of  experts  to  define  criteria  for  clinical  outcomes  with  the  structured  Delphi  method.  The  authors  argue  that  10  mmHg  is  more  appropriate  than  20  mmHg,  based  on  the  associated  decrease  in  cardiovascular  morbidity  and  mortality  from  studies  in  patients  with  primary  hypertension.  However,  data  from  primary  hypertensives  cannot  be  translated  to  patients  with  primary  aldosteronism  in  whom  a  complete  biochemical  response  to  treatment  is  essential4  (which  was  not  assessed  by  Vorselaars  et  al.1)  and  who  have  an  increased  cardiovascular  risk  compared  with  patients  with  primary  hypertension.5    3.    The  PASO  consensus  used  an  absolute  value  of  ≥  0.5  DDD  to  define  a  relevant  change  in  medication  and  not  a  50%  change.  Thus,  the  authors  have  incorrectly  applied  the  PASO  criteria  to  evaluate  outcomes.  According  to  table  4,  15  of  their  26  patients  had  a  decrease  in  DDD  of  >0.5  DDD,  so  these  15  patients  should  be  classified  as  partial  and  not  as  absent  clinical  success.      4.  Finally,  the  heterogeneous  approach  for  the  identification  of  surgically-­‐treatable  patients  (with  reliance  on  nonfunctional  imaging  in  36%  of  patients)  and  the  considerable  deviation  from  the  PASO  recommendations  for  the  timeframe  of  follow  up  in  68%  of  patients  underlines  further  the  inappropriateness  of  comparing  data  from  Vorselaars  et  al.1  with  the  PASO  study.2    Tracy  Ann  Williams  PhD1,2  Jacques  WM  Lenders  MD  PhD3,4  Martin  Reincke  MD1  1Medizinische  Klinik  und  Poliklinik  IV,  Klinikum  der  Universität,  LMU  München,  Munich,  Germany  and  Department  of  Medicine    2Division  of  Internal  Medicine  and  Hypertension,  Department  of  Medical  Sciences,  University  of  Turin,  Turin,  Italy       2  3Radboud  University  Medical  Center,  Nijmegen,  The  Netherlands    4Department  of  Medicine  III,  University  Hospital  Carl  Gustav  Carus,  Technische  Universität  Dresden,  Dresden,  Germany    Corresponding  author  TAW:  Email:  Tracy.Williams@med.uni-­‐muenchen.de    Disclosure  statement  The  authors  declare  no  conflicts  of  interest    Funding  source  The  work  of  the  authors  is  supported  by  the  European  Research  Council  (ERC)  under  the  European  Union’s  Horizon  2020  research  and  innovation  programme  (grant  agreement  No  [694913]  to  M  Reincke)  and  by  the  Deutsche  Forschungsgemeinschaft  (DFG,  German  Research  Foundation)  Projektnummer:  314061271-­‐TRR  205  to  TA  Williams,  JWM  Lenders  and  M  Reincke.    References  1)   Vorselaars  WMCM,  Beek  DV,  Postma  EL,  Spiering  W,  Borel  Rinkes  IHM,  Valk  GD,  Vriens  MR;  International  CONNsortium  study  group.  Clinical  outcomes  after  surgery  for  primary  aldosteronism:  Evaluation  of  the  PASO-­‐investigators'  consensus  criteria  within  a  worldwide  cohort  of  patients.  Surgery.  2019  Apr  30.  pii:  S0039-­‐6060(19)30063-­‐7.  doi:  10.1016/j.surg.2019.01.031    2)   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.  Outcomes  after  adrenalectomy  for  unilateral  primary  aldosteronism:  an  international  consensus  on  outcome  measures  and  analysis  of  remission  rates  in  an  international  cohort.  Lancet  Diabetes  Endocrinol.  2017  Sep;5(9):689-­‐699.  doi:  10.1016/S2213-­‐8587(17)30135-­‐3    3)   Mancia  G,  Fagard  R,  Narkiewicz  K,  Redón  J,  Zanchetti  A,  Böhm  M,  Christiaens  T,  Cifkova  R,  De  Backer  G,  Dominiczak  A,  Galderisi  M,  Grobbee  DE,  Jaarsma  T,  Kirchhof  P,  Kjeldsen  SE,  Laurent  S,  Manolis  AJ,  Nilsson  PM,  Ruilope  LM,  Schmieder  RE,  Sirnes  PA,  Sleight  P,  Viigimaa  M,  Waeber  B,  Zannad  F;  Task  Force  Members.  2013  ESH/ESC  Guidelines  for  the  management  of  arterial  hypertension:  the  Task  Force  for  the  management  of  arterial  hypertension  of  the  European  Society  of  Hypertension  (ESH)  and  of  the  European  Society  of     3  Cardiology  (ESC).  J  Hypertens.  2013  Jul;31(7):1281-­‐357.  doi:  10.1097/01.hjh.0000431740.32696    4)   Hundemer  GL,  Curhan  GC,  Yozamp  N,  Wang  M,  Vaidya  A.  Cardiometabolic  outcomes  and  mortality  in  medically  treated  primary  aldosteronism:  a  retrospective  cohort  study.  Lancet  Diabetes  Endocrinol.  2018  Jan;6(1):51-­‐59.  doi:  10.1016/S2213-­‐8587(17)30367-­‐4.    5)   Monticone  S,  D'Ascenzo  F,  Moretti  C,  Williams  TA,  Veglio  F,  Gaita  F,  Mulatero  P.  Cardiovascular  events  and  target  organ  damage  in  primary  aldosteronism  compared  with  essential  hypertension:  a  systematic  review  and  meta-­‐analysis.  Lancet  Diabetes  Endocrinol.  2018  Jan;6(1):41-­‐50.  doi:  10.1016/S2213-­‐8587(17)30319-­‐4    

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Assessing outcomes after adrenalectomy for unilateral primary aldosteronism

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