We are running several registries on this technology:

-The RAI Registry is an italian multicenter prospective registry whose aim is to understand the long term (4-year) outcome of the Absorb (Abbott Vascular) BVS for coronary PCI. We have already published several researches on this topic, that you can find in the dedicated page. You can also find the study protocol (in italian). I am the PI for this study at our center.

-The IT-DISAPPEARS registry is a national prospective registry for complex coronary interventions with the Absorb (Abbott Vascular) BVS. The main sponsor for this study is the Italian Scientific Society of Interventional Cardiology GISE. You can find the study protocol here. I am the PI for this study at our center.

Twelve-month results of an unrestricted use of bioresorbable vascular scaffolds in a real world coronary artery disease population: primary outcome of the prospective RAI registry

During the EuroPCR 2017, I presented the results of the first year of Follow-Up for the RAI Registry, a spontaneous, multicenter, prospective data collection on consecutive patients undergoing BVS implantation in Italy.
The Objective of the Registry is to evaluate the long-term safety and efficacy of Absorb BVS within an unrestricted cohort of patients undergoing PCI. There have been enrolled 1505 Patients in 25 Italian Centers.

2 IMG_3789

Conclusion

•The RAI registry represents a real world, contemporary
BVS population, with very few exclusion criteria.
• The population enrolled is extremely well treated
(predilatation, postdilatation).
• Current-era BVS use, according to specific and
standardized techniques of implantation, show good
clinical outcome in an unrestricted patient population at
mid-term follow up.

Here’s the presentation of the meeting

2 RAI 12m

International Journal of Cardiology – Treatment of bifurcation lesions with drug-coated balloons: A review of currently available scientificdata

This is the article published in the International Journal of Cardiology 220 (2016) 589–594.

International Journal of Cardiology – Treatment of bifurcation lesions with drug-coated balloons: A review of currently available scientificdata

Bernardo Cortese (a,b,⁎), Davide Piraino (c), Dario Buccheri (a,c), Fernando Alfonso(d)
(a) Interventional Cardiology, A.O. Fatebenefratelli Milano, Italy
(b) Fondazione Monasterio CNR-Regione Toscana, Italy
(c) Interventional Cardiology,“P.Giaccone”Universitary Hospital of Palermo, Italy
(d) Interventional Cardiology, Hospital Universitario de La Princesa, Spain
(⁎) Corresponding author at: Interventional Cardiology, A.O. Fatebenefratelli Milano, Bastioni di Porta Nuova 21, 20100 Milano, Italy. E-mail address:bcortese@gmail.com (B. Cortese)

Conclusion

DCB use for bifurcation lesion management remains very attractive indeed as a complement of a provisional stenting strategy. However, currently available scientific evidence remains scarce and we still require additional data to refine its real clinical value. However, an indiscriminate use of stents in this setting (complex stenting or any 2-stent technique) is associated with suboptimal Clinical and angiographic results. The use of a novel generation DES in the MB remains the strategy of choice for most patients that can be managed with a provisional stenting strategy. It is possible that newer technologies such as DCB and biovascular scaffolds might improve the short and long-term outcome of bifurcation lesions, allowing a limited use of permanent prosthesis, especially at the SB

DCB bifurcation review 16

International Journal of Cardiology – Biovascular scaffolds and reversible coronary aneurysm

This is the article published in the International Journal of Cardiology 214 (2016) 225–227.

Biovascular scaffolds and reversible coronary aneurysm

Bernardo Cortese (a,⁎), Pedro Silva Orrego (a), Kazuyuki Yahagi (b), Renu Virmani(b)
(a) Interventional Cardiology, A.O. Fatebenefratelli Milano, Italy
(b) CVPath Institute, Gaithersburg, MD, USA
(⁎) Corresponding author at: Interventional Cardiology, A.O. Fatebenefratelli Milano, Bastioni di Porta Nuova 21, 20100 Milano, Italy. E-mail address:bcortese@gmail.com (B. Cortese)

Conclusion

Late acquired scaffold malapposition is a possible complication, whose mechanism and clinical consequences are not yet definitely addressed. However, the natural fate of resorption with inflammation resulting in aneurysm and ectasia with subsequent healing of the currently available BVS could be responsible for the temporary nature of this phenomenon.
Supplementary data to this article can be found online at http://dx.doi.org/10.1016/j.ijcard.2016.03.167

BVS aneurysm reversal IJC 2016

DCB GIC 2017 – Nuove tecnologie e applicazioni per il pallone medicato nel 2017

This is the article published in G Ital Cardiol 2017.

Nuove tecnologie e applicazioni per il pallone medicato nel 2017

Bernardo Cortese (1,2), Gaetano Di Palma (1), Roberto Nerla (3), Antonio Micari (3)
(1) Cardiologia Interventistica, ASST Fatebenefratelli-Sacco, Milano
(2) U.O. Cardiologia Diagnostica e Interventistica, Fondazione “Gabriele Monasterio”-Regione Toscana-CNR, Massa
(3) Laboratorio di Cardio-Angiologia Diagnostica e Interventistica, Maria Cecilia Hospital, Cotignola (RA)

 

Conclusioni

I DCB sono in grado di superare alcune importanti limitazioni degli stent senza perdere la capacità di inibizione della proliferazione neo-intimale, ma deve essere chiaro che questi costituiscono una componente della strategia di rivascolarizzazione ottimale per i nostri pazienti, sempre più complessi, piuttosto che un’alternativa ai DES. Mentre il loro ruolo nella ISR è ormai ben definito, il trattamento di lesioni de novo, specie nel distretto coronarico, è la nuova frontiera e presenta ad oggi dati incoraggianti, ancorché preliminari. In ambito periferico, tali risultati sembrano non subire effetto di catch-upa 2-3 anni e si possono estendere sia a lesioni TASC A/B sia alle più complesse TASC C/D, così come alle sottopopolazioni di pazienti con lesioni severamente calcifiche, dove l’aterectomia costituisce un valido alleato del DCB, o la ISR.
I diversi DCB attualmente in commercio differiscono per la tecnologia che ne è alla base e, pertanto, hanno fornito risultati differenti in termini di efficacia a lungo termine, il che suggerisce l’assenza di un “effetto di classe” per i DCB in generale. Ogni differente tecnologia ha l’obbligo di dimostrare la sua efficacia e sicurezza in studi di adeguata ampiezza, qualità e rigore che possano confermare l’utilità nella pratica clinica dei dispositivi che entreranno in commercio da qui in avanti.

DCB review GIC 2017

BVS Experts Survey 2015 now published

This is the article just published in JACC as a Research Letter. It refers to the Survey that we conducted in 2015 and that was reserved to the most influencing experts on the Absorb BVS technology.

As you are probably aware, the FDA gave green light to Absorb to be sold in the US, so knowing what Experts do really think about BVS, specifically for the scaffold thrombosis issue, if of some importance.

Please, take your time to read alsoJAC_22510 the comments on the Survey made by Michael O’Riordan in TCTMD:

http://www.tctmd.com/show.aspx?id=135417&utm_source=TCTMD_News_062016&utm_medium=email&utm_campaign=TCTMD_Weekly_Newsbrief

EuroPCR coverage 1

This is the official TCTMD report on the late-breaking clinical trial session on BVS at the latest EuroPCR.

I am proud of being part of it, presenting the short-term data of the RAI registry. And I am also proud that our centre was the second top enroller centre in both the RAI and IT-DISAPPEARS registry!

http://www.tctmd.com/show.aspx?id=135200

BVS SAVE: The BVS-SAVE Italian registry: Bioresorbable Vascular Scaffolds for the Treatment of Small Vessel Disease

Much debate is currently running on BVS performance in small coronary vessels. I am here attaching one of the few publications available worldwide, that our group coordinated recently: the BVS SAVE study. This poster was presented at both the 2015 GISE and TCT meetings. Please take a look at the results.

BVS Survey 2014

This is the PPTX presentation of the BVS survey 2014, as presented at the BVS Advisory Board of Abbott in March 2015. This is a spontaneous survey dedicated to BVS Expert Users, and I shared this research with M. Valgimigli, Bern.

It is of some interest to see how Experts felt this technology by mid-2014, and a publication in the International Journal of Cardiology followed. Another Survey was depicted in 2015 and we are currently analyzing its results.

I am thus wishing you all a happy New Year!!

BVS survey2

@NEJM Ask the Authors & Experts: Everolimus-eluting Bioresorbable Scaffolds for Coronary Artery Disease & Bioresorbable Vascular Scaffolds–Will Promise Become Reality?

Hello, today the New England Journal of Medicine Group Open Forum will begin. I have been invited to participate as an expert on Absorb BVS among a very high level panel (please see below).

I suggest you to click the link and follow this very important way to disseminate knowledge. 

Research organization for the year 2015

For the current year, the Scientific Research at the cardiac Dpt. will have the following actors:

 

Head of cardiovascular research: Bernardo Cortese, MD

Assistant at research: Roberto Latini, MD

Fellows: Davide Piraino, MD, Dario Buccheri, MD

Data Manager: Elena Galfrascoli, Pharm D, Sophia Campbell, Pharm D (pic)

Data Monitor: Lorenzo Cagliani, Eng

the role of BVS in 2015

The most widely used Biovascular Scaffold worldwide, namely Absorb, Abbott, is a real revolution in interventional cardiology. A lot of things changed after BVS became available, however we learned that, most importantly, the approach to PCI did change as well: like for DCB-PCI, it is not just like to implant a stent here!

This is the presentation I made at Stresa, a national meeting organized by AS Bongo, Novara Hospital, in May 2015.

Cortese for website