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Barisa, Marlena (2014) The Adrenal Vein sampling International Study (AVIS): main results of phase 1 and 2 of the study. [Tesi di dottorato]

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Abstract (inglese)

Context. Primary aldosteronism (PA) is the most common form of secondary endocrine hypertension. To make a distinction between surgically-curable and surgically-non curable causes, the Endocrine Society guidelines recommend the use of adrenal venous sampling (AVS), which is considered invasive, technically challenging, difficult to interpret, and commonly held to be risky. However, whether and how these guidelines are interpreted in clinical practice is still unknown. Hence, the purpose of this PhD work was to set up a study, the Adrenal Vein sampling International Study (AVIS), to answer several questions concerning AVS.
Design and settings. AVIS is an observational, retrospective, multicenter international study. The eligible centers were identified among those that had published data about PA and/or AVS into English scientific literature during the period between 2005 and 2010. The study is designed in two phases, the first one is aimed to collect the data on AVS while the second one, the data on single patients.
Objective. In the first phase of the study, the main outcomes were to determine the complication rate of AVS and the ways in which it is performed and interpreted at major referral centers. Specifically, the rate of PA patients in whom AVS is performed and the number of AVS studies performed yearly between 2005 and 2010 per each center; the number of radiologists that perform AVS at each center and the rate of complication; the use of bilaterally simultaneous or sequential AVS catheterization and the use of cosyntropin stimulation during AVS; the use of AVS studies not bilaterally selective for diagnosis; the interpretation of AVS results by calculation of the selectivity, lateralization and contralateral suppression index and minimum cutoff value used; the cost of AVS for the National Health System/Insurance and for patients.
The second phase is aimed to collect individual patients data to assess the rate of bilaterally selective AVS studies as a function of the different cutoff values of the selectivity index; to identify the best cutoff value for the identification of the lateralized aldosterone excess; to clarify if contralateral suppression allows diagnosing lateralization when only unilateral (usually left-sided) AVS is successful; to assess the rate of the patients with lateralized aldosterone excess secretion cured by adrenalectomy; to establish whether medical therapy induces improvement of high blood pressure (BP) in PA subtypes characterized by bilateral aldosterone excess secretion; assess the rate of AVS concordant /discordant with results of imaging tests. For reasons of time and brevity in this preliminary analysis the data on contralateral suppression will not be included.
Results. Phase 1: Twenty out of 24 eligible centers from Europe, Asia, Australia and North America participated and provided information on 2604 AVS studies performed between 2005 and 2010. The percentage of PA patients systematically submitted to AVS was 77% (median, range: 19%-100%). The overall rate of adrenal vein rupture was 0.61% and it correlated directly with the number of AVS performed at a particular center (p=0.002) and inversely with the number of AVS performed by each radiologist (p=0.007). The total number of radiologists who performed AVS at the 20 centers was 51 (range, 1 to 7; median,2). Thirteen of the 20 centers used sequential and 7 bilaterally simultaneous catheterization; cosyntropin stimulation was used in 11 centers. No significant correlation has been found between the use of ACTH stimulation and sequential catheterization.
The cutoff values for selectivity and lateralization indices varied markedly among those centers that systematically used them. Selectivity index (SI) results to be calculated in 90% of the centers, and the cut off values varied under non-stimulated condition from 1.1 to 3, and under stimulate conditions between 2 and 10. Lateralization index (LI) is used in 95% of the centers and its cut off values varied under non-stimulated condition from 2 to 5, and under stimulate conditions between 2 and 4. Contralateral suppression index (CSI) was calculated in 65% of the centers and its cut off values varied under non-stimulated condition from 0.5 to 1, and under stimulate conditions between 0.9 and 1.
It was found out that 60% of centers used unilaterally selective studies when bilateral results were unavailable for the diagnosis and there was significant correlation between use of unilateral selective AVS and contralateral suppression (p=0,05). In contrast, no significant correlation was found between the use of ACTH stimulation and contralateral suppression. The costs of AVS showed a wide variability among centers and countries, both for the patient and for the insurance or national health care system. The cost ranged from 80 (€) to 10,532 € for health insurance systems and from 0 to 1,357 € for the patient.
Phase 2: Due to the delay of some centers in providing the data, we performed a preliminary analysis only with the available data. We collected information on 1.030 PA patients who underwent AVS in 13 referral centers worldwide. Resistant hypertension was found in 43% of the patients, 59% were men; the majority were Caucasians.
The analysis of overall improvement at follow up of high BP with either pharmacological or surgical treatment evidenced 19% of patients with cured high BP, 49% of patients with a markedly improved BP control, 25% with only a mild improvement of BP and 8% with no improvement of BP. The analysis evidenced that women, Caucasian and African had better outcomes.
As regards the outcome of BP in the adrenalectomized patients, BP was cured in 34% of cases, markedly improved in 45% of patients, mildly improved in 16% of patients and no improvement in 5% of the patients. Moreover, the rate of patients who underwent adrenalectomy was lower than expected (median 53%) with a high variability among centers. The analysis evidenced that in the patients with bilateral aldosterone excess no cases showed cured o markedly improved control of high BP while on pharmacological treatment. At follow up, the majority of the patients (about 75%) showed only a mildly improved control of BP, and 24% of the patients had no improvement.
The analysis of the rate of bilaterally selective AVS studies as a function of different cutoff values showed that lower SI cutoff values were associated with a higher rate of bilaterally selective studies. To evaluate the best cutoff value for identifying a lateralized aldosterone excess we examined the bilaterally selective studies (by different SI cutoffs), the performance of the different LI used across the centers using as reference index cure or marked improvement of BP at follow up after the adrenalectomy. This evidenced that, at each SI, the higher the LI cutoff the higher the rate of patients who were cured or markedly improved as far as BP control.
As regards the rate of concordance/discordance between AVS results and CT imaging results for the diagnosis of lateralized aldosterone excess, we performed the analysis in patients with bilaterally selective AVS, with evidence of lateralized aldosterone excess, who undergo to adrenalectomy and at follow up presented cured o markedly improved BP. This analysis evidence that in this subgroup of patients the rate of concordance between AVS results and CT imaging results was low, 65% on the left side and 57% on the right side.
Conclusions. Despite the high prevalence of PA, and the fact that AVS is crucial for discriminating between its two major subtypes, and therefore for selecting the most appropriate treatment, this study documented marked dissimilarities in the percentage of use, protocols, interpretation and cost of AVS even among the major referral centers around the world. Importantly, overall the rate of major complications was minimal, 0.61%, which demonstrates that although being generally regarded as a risky procedure, AVS is in truth safe in experienced hands. This observation therefore supports the Endocrine Society recommendation that AVS should be used in all patients with confirmed PA who are candidate for adrenalectomy and seek surgical cure.
In the second phase of the study, analysis of the individual patients data, evidence that a choice of more restrictive values of the selectivity and the lateralization index, translates to increased rates of cured and markedly improved BP at follow up, but this at the price of the exclusion of a greater number of patients from adrenalectomy.

Abstract (italiano)

Introduzione. L’iperaldosteronismo primario (PA) è la forma più comune di ipertensione arteriosa secondaria da causa endocrina. Per distinguere le forme chirurgicamente guaribili da quelle che esigono la sola terapia medica, le attuali linee guida dell’Endocrine Society raccomandano l'esecuzione del cateterismo venoso surrenalico (AVS), un’indagine ritenuta invasiva, rischiosa, tecnicamente difficile e di ardua interpretazione. Tuttavia non è ancora del tutto noto, se e come queste linee guida vengano applicate ed interpretate nella pratica clinica. Questo studio, the Adrenal Vein sampling International Study (AVIS), è stato ideato con l’intento di chiarire le modalità di utilizzo ed interpretazione dell’ AVS nei centri mondiali di riferimento.
Materiali e metodi. E’ uno studio retrospettivo, osservazionale, multicentrico, internazionale ed i centri partecipanti sono stati scelti tra quelli che hanno pubblicato dati su PA e AVS nella letteratura scientifica inglese nel periodo compreso tra il 2005 e il 2010. Lo studio prevede 2 fasi: la prima ha lo scopo di raccogliere i dati relativi alle modalità di esecuzione ed interpretazione dell’AVS, mentre la seconda di raccogliere i dati individuali dei pazienti sottoposti al AVS.
Obiettivi dello studio. I principali obiettivi della prima fase dello studio sono stati quelli di chiarire una serie di quesiti irrisolti inerenti all’utilizzo e alla performance diagnostica dell’AVS per la diagnosi di PA. In particolare, ci si è proposti di accertare: 1) la percentuale di pazienti con PA che vengono sottoposti ad AVS ed il numero di AVS eseguiti presso i maggiori centri internazionali di riferimento; 2) il tasso di complicanze (intese come rotture delle vene surrenaliche verificatesi durante l’AVS) e gli eventuali predittori delle stesse; 3) le modalità d’esecuzione dell’AVS; 4) le modalità di interpretazione ed utilizzo dei suoi dati; 5) la percentuale di utilizzo degli indici di selettività, di lateralizzazione e soppressione controlaterale ed i loro valori di riferimento; 6) il costo di AVS per il paziente ed il sistema sanitario dei diversi paesi.
Nella seconda parte dello studio sono stati raccolti i dati individuali dei pazienti sottoposti all’AVS per: valutare il tasso di AVS bilateralmente selettivi in funzione dei diversi valori soglia dell'indice di selettività; identificare il miglior valore soglia che identifica la lateralizzazione dell’aldosterone; chiarire se la soppressione controlaterale permette la diagnosi di lateralizzazione in presenza di AVS solo unilateralmente selettivi; valutare il tasso dei pazienti con ipersecrezione unilaterale dell’ aldosterone curata con la surrenectomia; stabilire se la terapia medica induce ad un miglioramento della pressione arteriosa in soggetti con ipersecrezione bilaterale del aldosterone; valutare la concordanza / discordanza tra test radiologici ed AVS nella diagnosi di lateralizzazione di aldosterone. Per motivi di tempo e di brevità di questa analisi preliminare, i dati sulla soppressione controlaterale non saranno inclusi.
Risultati. Fase 1: sono stati raccolti dati su 2604 AVS eseguiti presso 20 centri mondiali di riferimento sparsi in Europa, Asia, Nord America e Australia. Dall’analisi dei risultati è emerso che la percentuale di pazienti con PA, sistematicamente sottoposti all’AVS, è pari al 77%, con un’ampia variabilità tra i diversi centri (dal 40% al 100%). La percentuale di complicanze è risultata pari allo 0.61%, con correlazione significativa tra il numero di complicanze ed il numero di AVS eseguiti presso ogni singolo centro (p=0.002) e correlazione inversamente proporzionale al numero di AVS eseguiti dal singolo radiologo (p=0.007).
Il numero di radiologi che eseguono l’AVS nei singoli centri è mediamente di 2 radiologi/centro (variabile tra 1 e 7) ad eccezione di 2 centri, dove rispettivamente 6 e 7 radiologi erano coinvolti nell’esecuzione della procedura. La maggior parte dei centri (13/20) utilizza il cateterismo sequenziale e solo 7 centri il cateterismo simultaneo bilaterale. Per quanto riguarda l’impiego del test di stimolazione con ACTH i centri si sono distribuiti quasi equamente tra quelli che utilizzano tale stimolazione (55%) e quelli che non la utilizzano (45%). Dalle analisi non è emersa una correlazione tra il cateterismo sequenziale e l’utilizzo del test di stimolazione con ACTH.
L’indice di selettività (SI) viene calcolato nel 90% dei centri ed i suoi valori di riferimento variano da 1.1 a 3 in condizioni basali e da 2 a 10 dopo la stimolazione con ACTH. Un centro utilizza solo i valori ormonali assoluti, mentre un altro centro non calcola il SI ma solo gli indici di lateralizzazione e soppressione controlaterale. L’indice di lateralizzazione (LI) è calcolato nel 95% dei centri ed i suoi valori di riferimento variano da 2 a 5 in condizioni basali e da 2 a 4 dopo la stimolazione con ACTH. L’indice di soppressione controlaterale (CSI) viene calcolato in 65% dei centri e i suoi valori di riferimento variano da 0.5 a 1 in condizioni basali e da 0.9 a 1 dopo la stimolazione con ACTH. Non è emersa una correlazione significativa tra l’utilizzo della stimolazione con ACTH ed il calcolo del CSI. In caso di non disponibilità di AVS bilateralmente selettivi, il 60 % dei centri utilizza per diagnosi anche gli AVS non selettivi bilateralmente. E’ stata trovata una correlazione significativa (p=0.05) tra l’uso di AVS non selettivi ed il calcolo del CSI. Per quanto riguarda i costi dell’AVS, i risultati di questa analisi hanno evidenziato un’ampia variabilità tra i diversi centri ed i diversi paesi. Il costo del singolo AVS varia da 80 a 10.532 euro per il sistema sanitario nazionale e da 0 a 1.357 euro a carico del paziente.
Fase 2: l’analisi dei dati della seconda fase dello studio è stata eseguita solo su dati parziali, a causa del ritardato inserimento degli stessi da parte di alcuni centri. In questa analisi preliminare sono state raccolte informazioni su 1.030 pazienti con PA sottoposti all’ AVS, provenienti da 15 centri differenti. Il 43% dei pazienti presentava ipertensione arteriosa resistente, il 59% era di sesso maschile e la razza caucasica era quella predominante.
L’analisi del miglioramento della pressione arteriosa, indipendentemente dal tipo di trattamento (medico o chirugico), al follow up ha evidenziato il 19% di pazienti normotesi, il 49% con significativo miglioramento della pressione - definita come pressione arteriosa normale con lo stesso o ridotto numero di farmaci e/o pressione arteriosa simile a quella basale, ma con una marcata diminuzione di farmaci (> 2 farmaci) - , il 25% ha presentato solo un lieve miglioramento della pressione arteriosa - riduzione della pressione arteriosa sistolica o distolica >10%, senza il raggiungimento della normotensione con lo stesso o ridotto numero di farmaci - , mentre, l’ 8% dei casi non ha presentato alcun miglioramento. Le donne ed i soggetti di razza caucasica o africana presentavano un outcome migliore. Per quanto riguarda l’outcome pressorio nei pazienti surrectomizzati, al follow up, il 34% dei pazienti era normoteso, il 45% con significativo miglioramento della pressione, il 16% ha presentato solo un lieve miglioramento e nel 5% dei casi non c’era alcun miglioramento. Dall’analisi è stata evidenziata anche la bassa percentuale di pazienti sottoposti alla surrenectomia, in media il 53% dei pazienti, con ampia variabilità tra i diversi centri. Per quanto riguarda il controllo della pressione arteriosa con la sola terapia medica nei soggetti con ipersecrezione bilaterale di aldosterone, la maggioranza (circa il 75%) ha presentato solo un lieve miglioramento del controllo pressorio, mentre nel 24% dei casi non c’era alcun miglioramento.
La valutazione del tasso di AVS bilateralmente selettivi in funzione dei diversi valori-soglia dell'indice di selettività, ha evidenziato che, l’aumento del numero di AVS bilateralmente selettivi, era inversamente proporzionale al valore soglia del SI, sia in condizioni basali che dopo lo stimolo con ACTH. Per identificare il miglior valore soglia che identifica la lateralizzazione dell’aldosterone, sono stati esaminati i pazienti con AVS bilateralmente selettivi, con evidenza di ipersecrezione unilaterale di aldosterone, sottoposti a surrenectomia, che al follow up presentavano l’ipertensione arteriosa curata o significatamene migliorata. Questa analisi ha evidenziato che, ad ogni SI, maggiore è il valore soglia che identifica la lateralizzazione dell’aldosterone, più alto è il tasso di pazienti con ipertensione arteriosa curata o significatamene migliorata.
Per quanto riguarda la concordanza tra test radiologici ed AVS nella diagnosi di lateralizzazione di aldosterone, l’analisi condotta nel gruppo di pazienti con AVS bilateralmente selettivo, con evidente lateralizzazione dell’aldosterone, sottoposti alla surrenectomia, ha evidenziato concordanza tra i 2 test diagnostici in solo il 57% dei casi a destra e il 65% dei casi a sinistra.
Conclusioni. Nonostante il fatto che il PA sia la forma più comune di ipertensione arteriosa secondaria da causa endocrina e che l’AVS sia ritenuto indagine “gold standard” per la diagnosi differenziale tra i suoi due principali sottotipi, e quindi per la scelta del trattamento più appropriato (medico o chirurgico), i risultati della prima fase dello studio AVIS hanno documentato l’esistenza di marcate diversità nella percentuale di utilizzo, nelle modalità d’esecuzione e d’interpretazione nei diversi centri di riferimento mondiali.
Lo studio ha evidenziato un tasso di complicanze globalmente minimo, pari allo 0.61%. Quindi nonostante l’AVS sia generalmente considerato un’indagine invasiva, in realtà in presenza di mani esperte, esso risulta essere sicuro. Questo dato conferma le raccomandazioni delle attuali linee guida dell’Endocrine Society di sottoporre ad AVS tutti i pazienti con PA in assenza di controindicazioni al trattamento chirurgico.
La fase 2 dello studio attraverso l’analisi dei dati individuali ha evidenziato che la scelta di valori più restrittitivi dell’indice di selettività e dell’indice di lateralizzazione si traduce in maggiori tassi di guarigione e miglioramento dell’ipertensione arteriosa, al prezzo dell’esclusione di un numero maggiore di pazienti dalla surrenectomia.

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Tipo di EPrint:Tesi di dottorato
Relatore:Rossi, Gian Paolo
Dottorato (corsi e scuole):Ciclo 26 > Corsi 26 > Ipertensione Arteriosa e Biologia Vascolare
Data di deposito della tesi:31 Gennaio 2014
Anno di Pubblicazione:31 Gennaio 2014
Parole chiave (italiano / inglese):iperaldosteronismo primario/adrenal vein sampling
Settori scientifico-disciplinari MIUR:Area 06 - Scienze mediche > MED/09 Medicina interna
Struttura di riferimento:Dipartimenti > Dipartimento di Medicina
Codice ID:6821
Depositato il:07 Nov 2014 15:17
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