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The Outcomes of Primary Aldosteronism Patients in the AVIS-2 Study

28 Pages Posted: 28 Jan 2019

See all articles by Gian Paolo Rossi

Gian Paolo Rossi

University of Padova - Hypertension Unit

Giacomo Rossitto

Hôpital Européen Georges Pompidou

Laurence Amar

Hôpital Européen Georges Pompidou

Michele Azizi

Hôpital Européen Georges Pompidou

Anna Riester

Klinikum der Universität München

Martin Reincke

Klinikum der Universität München

Christoph Degenhart

Klinikum der Universität München

Jiri Widimsky Jr.

Charles University in Prague

Mitsuhide Naruse

National Hospital Organization (NHO) - Kyoto Medical Centre

Jaap Deinum

Radboud University Nijmegen

Leo Schultzekool

Radboud University Nijmegen

Tomaz Kocjan

University Medical Centre Ljubljana

Aurelio Negro

Arcispedale Santa Maria Nuova - IRCCS

Ermanno Rossi

Arcispedale Santa Maria Nuova - IRCCS

Gregory Kline

University of Calgary

Akiyo Tanabe

Tokyo Women's Medical University

Fumitoshi Satoh

Tohoku University Hospital

Lars Christian Rump

Heinrich Heine University Dusseldorf

Oliver Vonend

Heinrich Heine University Dusseldorf

Holger S. Willenber

Heinrich Heine University Dusseldorf

Werner A. Scherbaum

University of Rostock

Peter Fuller

University of Rostock

Jun Yang

University of Rostock

Nicholas Yong Nian Chee

University of Rostock

Steven B. Magill

Monash Health

Zulfiya Shafigullina

Medical College of Wisconsin

Marcus Quinkler

Saint Petersburg State University

Anna Oliveras

Charité - Universitätsmedizin Berlin

Kwan Dun Wu

Autonomous University of Barcelona

Vin Cent Wu

Tokyo Women's Medical University

Zusana Somloova

Charles University in Prague

Giulio Barbiero

National Taiwan University - National Taiwan University Hospital (NTUH)

Michele Battistel

National Taiwan University - National Taiwan University Hospital (NTUH)

Paul-Emmanuele Vanderriele

University of Padova

Achille C. Pessina

University of Padova

More...

Abstract

Background: Adrenal venous sampling (AVS) is the key test recommended by guidelines for primary aldosteronism (PA) patients seeking surgical cure, but its clinical outcomes have never been determined in large scale trials.  

Methods: We created a large multicentre international registry of individual AVS studies carried out at major referral centres worldwide to determine the clinical outcomes of this test.   Findings. We analysed 1625 consecutive individual AVS studies performed between 2000 and 2015 in 19 tertiary referral centres located in Asia, Australia, Europe and North America. AVS, which was successful in 80.1% of all cases, allowed identification of lateralization of PA in only 45.5%, according to criteria in use at each centre. Adrenalectomy was performed in 41.8% of the patients and cured arterial hypertension, two-fold more frequently in women than men (p<0.001). When AVS-guided, surgery provided a higher rate of cure of hypertension than when non-AVS-guided (40.0 vs 30.5%, p=0.027). Overall, patients treated with medical therapy exhibited a higher rate of persistent hypokalaemia requiring potassium supplementation (4.9% vs 2.3%; p<0.01) and needed more antihypertensive medications (p<0.001).  

Interpretation: The low rate of adrenalectomy and cure of hypertension in PA patients seeking surgical cure indicate suboptimal use of AVS. Given the better outcomes of AVS-guided surgical decision-making, these results call for actions to improve the diagnostic use of this test that is key for referring PA patients for adrenalectomy.  

Trial Registration Number: The AVIS was registered at clinicaltrials.gov number NCT01234220. (The original protocol of AVIS-2, which started in 2012 as an observational multicentre study of individual consecutive AVS studies performed worldwide, was registered at clinicaltrials.gov (NCT01234220), and thereafter slightly amended to reach the target recruitment number of 1500 patients PA patients submitted to AVS.)

Funding Statement: This study was supported in part by research grants to GPR from FORICA (The FOundation for advanced Research In Hypertension and CArdiovascular diseases) and the Società Italiana dell’Ipertensione Arteriosa and from the Else Kröner-Fresenius-Stiftung to M.R.

Declaration of Interests: The authors state: "There is no conflict of interest and financial disclosure to be disclosed."

Ethics Approval Statement: All procedures were carried out according to the Helsinki Declaration. The protocol of the study was approved by the Ethics Committee of both coordinating and participating centres.

Keywords: endocrine hypertension; primary aldosteronism; subtyping; diagnosis; adrenal vein sampling; outcome.

Suggested Citation

Rossi, Gian Paolo and Rossitto, Giacomo and Amar, Laurence and Azizi, Michele and Riester, Anna and Reincke, Martin and Degenhart, Christoph and Widimsky Jr., Jiri and Naruse, Mitsuhide and Deinum, Jaap and Schultzekool, Leo and Kocjan, Tomaz and Negro, Aurelio and Rossi, Ermanno and Kline, Gregory and Tanabe, Akiyo and Satoh, Fumitoshi and Rump, Lars Christian and Vonend, Oliver and Willenber, Holger S. and Scherbaum, Werner A. and Fuller, Peter and Yang, Jun and Nian Chee, Nicholas Yong and Magill, Steven B. and Shafigullina, Zulfiya and Quinkler, Marcus and Oliveras, Anna and Dun Wu, Kwan and Cent Wu, Vin and Somloova, Zusana and Barbiero, Giulio and Battistel, Michele and Vanderriele, Paul-Emmanuele and Pessina, Achille C., The Outcomes of Primary Aldosteronism Patients in the AVIS-2 Study (January 21, 2019). Available at SSRN: https://ssrn.com/abstract=3321491

Gian Paolo Rossi (Contact Author)

University of Padova - Hypertension Unit ( email )

Padova
Italy

Giacomo Rossitto

Hôpital Européen Georges Pompidou

France

Laurence Amar

Hôpital Européen Georges Pompidou

France

Michele Azizi

Hôpital Européen Georges Pompidou

France

Anna Riester

Klinikum der Universität München

Munich, 80336
Germany

Martin Reincke

Klinikum der Universität München

Munich, 80336
Germany

Christoph Degenhart

Klinikum der Universität München

Munich, 80336
Germany

Jiri Widimsky Jr.

Charles University in Prague

Celetná 13
Praha 1, 116 36
Czech Republic

Mitsuhide Naruse

National Hospital Organization (NHO) - Kyoto Medical Centre

Kyoto
Japan

Jaap Deinum

Radboud University Nijmegen

Postbus 9108
Nijmegen, 6500 HK
Netherlands

Leo Schultzekool

Radboud University Nijmegen

Postbus 9108
Nijmegen, 6500 HK
Netherlands

Tomaz Kocjan

University Medical Centre Ljubljana

Zaloška cesta 7
1000 Ljubljana
Slovenia

Aurelio Negro

Arcispedale Santa Maria Nuova - IRCCS

Viale Risorgimento
Reggio Emilia, 42123
Italy

Ermanno Rossi

Arcispedale Santa Maria Nuova - IRCCS

Viale Risorgimento
Reggio Emilia, 42123
Italy

Gregory Kline

University of Calgary

University Drive
Calgary, Alberta T2N 1N4
Canada

Akiyo Tanabe

Tokyo Women's Medical University

8-1 Kawadacho
Shinjuku
Tokyo, 162-8666
Japan

Fumitoshi Satoh

Tohoku University Hospital

1-1 Seiryomachi, Aoba Ward
Miyagi Prefecture, 980-8574
Japan

Lars Christian Rump

Heinrich Heine University Dusseldorf

Universitätsstrasse 1
Duesseldorf, DE NRW 40225
Germany

Oliver Vonend

Heinrich Heine University Dusseldorf

Universitätsstrasse 1
Duesseldorf, DE NRW 40225
Germany

Holger S. Willenber

Heinrich Heine University Dusseldorf

Universitätsstrasse 1
Duesseldorf, DE NRW 40225
Germany

Werner A. Scherbaum

University of Rostock

Postfach 10 08 88
Rostock, 18055
Germany

Peter Fuller

University of Rostock

Postfach 10 08 88
Rostock, 18055
Germany

Jun Yang

University of Rostock

Postfach 10 08 88
Rostock, 18055
Germany

Nicholas Yong Nian Chee

University of Rostock

Postfach 10 08 88
Rostock, 18055
Germany

Steven B. Magill

Monash Health

Australia

Zulfiya Shafigullina

Medical College of Wisconsin

8701 Watertown Plank Road
Milwaukee, WI 53226
United States

Marcus Quinkler

Saint Petersburg State University

7/9 Universitetskaya emb.
Saint Petersburg, 199034
Russia

Anna Oliveras

Charité - Universitätsmedizin Berlin

Charitéplatz 1
Berlin, 10117
Germany

Kwan Dun Wu

Autonomous University of Barcelona

Plaça Cívica
Cerdañola del Valles
Barcelona, Barcelona 08193
Spain

Vin Cent Wu

Tokyo Women's Medical University

8-1 Kawadacho
Shinjuku
Tokyo, 162-8666
Japan

Zusana Somloova

Charles University in Prague

Celetná 13
Praha 1, 116 36
Czech Republic

Giulio Barbiero

National Taiwan University - National Taiwan University Hospital (NTUH)

Taipei, 10048
Taiwan

Michele Battistel

National Taiwan University - National Taiwan University Hospital (NTUH)

Taipei, 10048
Taiwan

Paul-Emmanuele Vanderriele

University of Padova

Via 8 Febbraio
Padova, 2-35122
Italy

Achille C. Pessina

University of Padova

Via 8 Febbraio
Padova, 2-35122
Italy

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