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Napodano, Massimo (2017) Treatment of spontaneous coronary artery dissection by bio-resorbable vascular scaffolds. [Ph.D. thesis]

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Abstract (english)

BACKGROUND
SUMMARY
Spontaneous coronary artery dissection (SCAD) is a rare, but perhaps underestimate cause of acute coronary syndrome, and recent studies reported a surge in the recognition of this condition, particularly in young women presenting with acute coronary syndrome. However, despite the latest insights in epidemiological knowledge and advance in diagnostic capability using intracoronary tomographic imaging, the management of SCAD remains unsettled. Bioresorbable vascular scaffold (BRS) might represent an attractive therapeutic tool in SCAD, allowing for transient sealing of intimal flap and scaffolding of intramural hematoma, overcoming late pathology related to metallic stent. At the same time, BRS implantation could reduce the risk of late malapposition due to intramural hematoma reabsorption. The aim of this study was to investigate feasibility and safety of BRS in SCAD.
METHODS
In a multicenter prospective registry, 27 patients affected by SCAD presenting with ACS and treated by BRS between 2013 and 2015 were included. Diagnosis of SCAD was based on angiography when pathognomonic angiographic appearance with contrast dye staining of the arterial wall with multiple radiolucent lumens was appreciated (type I of Saw Classification); smooth and diffuse narrowing with abrupt change in arterial caliber, with demarcation from normal diameter to diffuse narrowing, or long and linear stenosis, or hazy long lesions (type II and III of Saw classification) were considered as SCAD, especially in absence of atherosclerotic changes in the other vessels and high clinical suspicion of SCAD; when angiography was considered inconclusive diagnosis was definitely accomplished by IVUS Inclusion criteria were: SCAD with ongoing ischemia, or flow-limiting, or severe lumen narrowing and proximal location, visual estimated RVD > 2.5 mm < 4.0 mm. Exclusion criteria were: pregnancy, contraindication to DAPT, hyper-reactivity to poly-lactate. In SCAD type II and III, IVUS/OCT was strongly suggested to confirm diagnosis. Angiographic success was defined as successful delivery of BRS at intended target lesion with TIMI-3 flow and stenosis <30%; clinical procedural success (patient level) as angiographic success without the occurrence of cardiac death, myocardial infarction/re-infarction or target vessel revascularization (TVR) during the hospital stay. Clinical plus CT-scan or angiography was planned at 12-months follow-up.

RESULTS
All but 2 patients were female, mean age 48±9 years; risk factors for SCAD were identified in 14 patients. Presentation was STEMI (48%), NSTE-ACS (37%), or life-threatening arrhythmias (15%). LAD was the most common culprit vessel (69%); 2 patients underwent BRS on 2 vessels: thus, 29 coronary arteries were treated. Revascularization was accomplished with 1 to 5 BRS per patient (mean total scaffold length 57±28 mm). IVUS guidance was used in 45%, post-dilatation in 72%. Device success was obtained in 100% of cases. Angiographic success was achieved in 28 of 29 (97%) lesions. Procedural success was achieved in 25 of 27 (93%) patients. No in-hospital deaths or non-fatal myocardial re-infarction were observed; 1 patient underwent TVR due to symptomatic SCAD progression at scaffolds’ edge. At 1-year follow-up, 1 TVR due to asymptomatic BRS recoil was observed. Coronary imaging (either invasive or not invasive) follow- up was performed in 15 patients with 1 year follow up showing BVS patency in 14 of 15 cases; one case of recurrent SCAD and one case of SCAD persistence were registered.
CONCLUSIONS
Our study, on the largest cohort of patients to date, suggests the feasibility and safety of bio- resorbable coronary scaffolds in Spontaneous Coronary Artery Dissection, with high rates of
angiographic and procedural success, and favorable 1-year results. Nevertheless, longer evaluation in larger studies is needed.

Abstract (italian)

La dissezione spontanea dell'arteria coronarica (SCAD) è una causa rara, ma forse sottostima della sindrome coronarica acuta, e recenti studi hanno riportato un'impennata nel riconoscimento di questa condizione, in particolare nelle giovani donne che presentano una sindrome coronarica acuta. Tuttavia, nonostante gli ultimi approfondimenti in materia di conoscenze epidemiologiche e il progresso nelle capacità diagnostiche mediante imaging tomografico intracoronarico, la gestione dello SCAD rimane instabile. Lo scaffold vascolare bioriassorbibile (BRS) potrebbe rappresentare un interessante strumento terapeutico in SCAD, consentendo la chiusura transitoria del lembo intimale e l'impalcatura dell'ematoma intramurale, superando la patologia tardiva correlata allo stent metallico. Allo stesso tempo, l'impianto di BRS potrebbe ridurre il rischio di malformazioni tardive a causa del riassorbimento dell'ematoma intramurale. Lo scopo di questo studio era di studiare la fattibilità e la sicurezza di BRS in SCAD.
METODI
In un registro prospettico multicentrico, sono stati inclusi 27 pazienti affetti da SCAD che presentano ACS e trattati da BRS tra il 2013 e il 2015. La diagnosi di SCAD si è basata sull'angiografia quando è stato apprezzato l'aspetto angiografico patognomonico con colorazione a colorante a contrasto della parete arteriosa con più lumi radiotrasparenti (tipo I della Classificazione delle seghe); restringimento regolare e diffuso con bruschi cambiamenti nel calibro arterioso, con demarcazione da diametro normale a restringimento diffuso, o stenosi lunga e lineare, o nebbiose lesioni lunghe (tipo II e III di classificazione Saw) sono stati considerati come SCAD, soprattutto in assenza di cambiamenti aterosclerotici nelle altre navi e alto sospetto clinico di SCAD; quando l'angiografia è stata considerata una diagnosi inconcludente è stata sicuramente raggiunta da IVUS I criteri di inclusione erano: SCAD con ischemia in atto, limitazione del flusso o restringimento del lume grave e localizzazione prossimale, RVD visivo stimato> 2,5 mm <4,0 mm. I criteri di esclusione erano: gravidanza, controindicazione al DAPT, iper-reattività al polilattato. In SCAD di tipo II e III, IVUS / OCT è stato fortemente suggerito per confermare la diagnosi. Il successo angiografico è stato definito come il successo del rilascio di BRS alla lesione target designata con flusso TIMI-3 e stenosi <30%; successo procedurale clinico (livello del paziente) come successo angiografico senza il verificarsi di morte cardiaca, infarto miocardico / reinfarto o rivascolarizzazione della vaso bersaglio (TVR) durante la degenza ospedaliera. A 12 mesi di follow-up è stato pianificato un esame clinico con TC o angiografia.
RISULTATI
Tutti tranne 2 pazienti erano di sesso femminile, età media 48 ± 9 anni; i fattori di rischio per SCAD sono stati identificati in 14 pazienti. La presentazione era STEMI (48%), NSTE-ACS (37%) o aritmie potenzialmente letali (15%). LAD era la nave colpevole più comune (69%); 2 pazienti sono stati sottoposti a BRS su 2 vasi: sono state quindi trattate 29 arterie coronarie. La rivascolarizzazione è stata eseguita con da 1 a 5 BRS per paziente (lunghezza totale media dell'impalcatura 57 ± 28 mm). La guida IVUS è stata utilizzata nel 45%, post-dilatazione nel 72%. Il successo del dispositivo è stato ottenuto nel 100% dei casi. Il successo angiografico è stato raggiunto in 28 su 29 (97%) lesioni. Il successo procedurale è stato raggiunto in 25 su 27 (93%) pazienti. Non sono stati osservati decessi in ospedale o reinfarto miocardico non fatale; 1 paziente è stato sottoposto a TVR a causa della progressione SCAD sintomatica sul bordo dello scaffold. Al follow-up a 1 anno, è stato osservato 1 TVR a causa del rinculo BRS asintomatico. Il follow-up di imaging coronarico (invasivo o non invasivo) è stato eseguito in 15 pazienti con follow up a 1 anno che mostravano la pervietà di BVS in 14 casi su 15; un caso di SCAD ricorrente e un caso di persistenza SCAD sono stati registrati.
CONCLUSIONI
Il nostro studio, sulla più ampia coorte di pazienti fino ad oggi, suggerisce la fattibilità e la sicurezza degli scaffold coronarici bio-riassorbibili nella dissezione dell'arteria coronaria spontanea, con alti tassi di successo angiografico e procedurale e risultati favorevoli a 1 anno. Tuttavia, è necessaria una valutazione più lunga in studi più ampi

EPrint type:Ph.D. thesis
Tutor:Iliceto, Sabino
Ph.D. course:Ciclo 29 > Corsi 29 > SCIENZE MEDICHE, CLINICHE E SPERIMENTALI
Data di deposito della tesi:20 September 2018
Anno di Pubblicazione:October 2017
Key Words:spontaneous, dissection, coronary, scaffolds
Settori scientifico-disciplinari MIUR:Area 06 - Scienze mediche > MED/11 Malattie dell'apparato cardiovascolare
Struttura di riferimento:Dipartimenti > Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari
Istituti > Istituto di Anatomia Patologica
Codice ID:11312
Depositato il:16 Nov 2018 09:36
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