The Italian Registry for Carotid Stenting

(RISC)

Giorgio M. Biasi^ MD, Alberto Cremonesi° MD, Luigi Inglese* MD

(On Behalf of the Executive Committee)

^ Dept. of Surgical Sciences and Intensive Care- University of Milan Bicocca   Bassini/S. Gerardo Teaching Hospitals - Milan

 ° Cardio-Angiology Interventional Unit- Villa Maria Cecilia Hospital-Cotignola (RA) 

*Service of Hemodynamic and Interventional Radiology- San Donato Hospital- Milan

The following Centres participated in the Study:

Istituto Policlinico San Donato, U.O. di Chirurgia Vascolare 1a – San Donato Milanese - D. Tealdi, MD; Istituto Policlinico San Donato, Servizio di Emodinamica e Radiologia Interventistica – San Donato Milanese – L. Inglese, MD; Azienda Ospedaliera G. Salvini, U.O. di Chirurgia Vascolare – Garbagnate Milanese – R. Mattassi, MD; Ospedale Maggiore C.A. Pizzardi, Servizio di Radiologia 2a – Bologna, A. Ziosi, MD; Centro Nazionale per il Salvataggio d’Arto – Milano – E. Calabrese, MD; EMO Centro Cuore Columbus – Milano – A. Colombo, MD; Policlinico Le Scotte, U.O. di Chirurgia Vascolare – Siena – C. Setacci, MD; Azienda Ospedaliera Cà Granda Niguarda, U.O. di Chirurgia Vascolare – Milano – M. Puttini, MD; Casa Sollievo della Sofferenza, Servizio di Radiologia Interventistica – San Giovanni Rotondo – W. Lauriola, MD; Cliniche Gavazzeni, U.O. di Neuroradiologia – Bergamo – P. Sganzerla, MD; Ospedale Maggiore San Giovanni Battista Molinette, Servizio di Angioradiologia Interventistica – Torino – C. Rabbia, MD; Ospedale Mauriziano Umberto I, Servizio di Radiologia -–Torino – P. Carbonatto, MD; Azienda Ospedaliera San Gerardo Ospedale Bassini, U.O. di Chirurgia Vascolare – Cinisello Balsamo – G. Deleo, MD; Ospedale Civile Sant’Agostino, U.O. di Chirurgia Vascolare – Modena – G. Coppi, MD; Policlinico Tor Vergata, Servizio di Radiologia – Roma – G. Simonetti, MD; Policlinico Umberto I, U.O. di Chirurgia Vascolare – Roma – F. Benedetti Valentini, MD; Policlinico Sant’Orsola, U.O. di Chirurgia Vascolare – Bologna – M. D’Addato, MD; Villa Maria Cecilia Hospital, Servizio di Emodinamica - Cotignola – A. Cremonesi, MD; Azienda Ospedaliera Santissima Annunziata, Servizio di Radiologia – Taranto – M. Resta, MD; Policlinico Le Scotte, U.O. di Neuroradiologia – Siena – C. Venturi, MD; Azienda Ospedaliera Sant’Anna, Servizio di Emodinamica – Como – R. Galli, MD; Ospedale di Careggi, U.O. Cardiologia 2a – Firenze – M. Santoro, MD; Azienda Ospedaliera Manzoni, U.O. di Chirurgia Vascolare – Lecco – G. Lorenzi, MD.

RISC has been proposed and established by specialists of different disciplines involved in the treatment of carotid artery bifurcation lesions.

 

The objective is to set up a multidisciplinary working group which feeds the registry with data on carotid stenting.

  DISCIPLINES INVOLVED

Vascular Surgery

Cardiology

Radiology

Neuroradiology

RISC has been endorsed by the National

Scientific Societies of all the specialities involved:

• Italian Society for Vascular and Endovascular Surgery (SICVE)

• Italian Society of Invasive Cardiology (GISE)

• Italian Society of Medical Radiology (SIRM)

• Italian Association of Neuroradiology (AINR)

INCLUSION CRITERIA FOR CENTRES

Background of at least 10 stenting procedures in the last 12 months.

To have a vascular surgeon as part of the team of the Centre.

To comply with the guide-lines set forth by the scientific societies for each discipline.

  RECRUITMENT OF THE PATIENTS AND DATA COLLECTION

Recruitment within 24 hs prior to procedure.

Collection of data on procedure and clinical conditions of the patient within 72 hours after procedure.

Collection of neurological data from a neurologist within 7 days after the procedure.

Follow-up controls at 1, 6, 12 and 24 months after procedure.

CAUSES OF EXCLUSIONS AFTER RECRUITMENT 

• Angiographic visualisation of a less significative stenosis than estimated

• Patient’s refusal of procedure

• Organisational problems

Each Centre has to

motivate the reason for

exclusion of the patient

after recruitment

ESTABLISHMENT OF AN INDEPENDENT SCIENTIFIC COMMITTEE

Quality control of data

On site visits

DATE OF ESTABLISHMENT OF REGISTRY: 22 October 2001

TOTAL REGISTERED CENTRES:

30

PRELIMINARY DATA AT DECEMBER 2002

Total carotid procedures entered 846

Total patients excluded after recruitment 186

Total patients lost to follow-up 15

RISCPreliminary Results

• Age

Min: 42 ys

Max: 91 ys

Mean: 72.3 ys

• 645 patients

446 males (69.1%)

199 females (30.9%)

645 IC

IN & INR

VS272 (42 %) 169 (26 %)

204 (32%)

FROM

10/2001

12/2001

02/2002

04/2002

06/2002

08/2002

10/2002

12/2002

0

10

20

30

40

50

60

70

80N

um

be

r o

f P

atie

nts

DATE

Trend of monthly recruitment

RISCPreliminary Results

PATHOLOGY

18%

82%

Primary Lesions

Restenosis

Pre-Procedural Symptomatic Patients

202 (31.3%)

TIAs 118 (58.4 %)

Stroke 46 (22.8 %)

Amaurosis 38 (18.8 %)

RISCPreliminary Results

PREOPERATIVE CT SCAN

Positive 309 (47.9 %) Negative 336 (52.1%)

RISCPreliminary Results

73/443 (16.5%)

Asymptomatic patients with

positive correlated CT scan

Stent 639 (99.07%)

Carotid Wallstent Boston S. 432 (67.6%)

Acculink Guidant 140 (21.9%)

Precise Cordis 21 (3.3%)

Medtronic C.S. 7 (1.1%)

Others 39 (6.1%)

RISCPreliminary Results

RISCPreliminary Results

• Pre - Stenting Dilatation

• Post - Stenting Dilatation

152 (23.6%)

582 (91.1%)

Cerebral Protection : 551 (85.4%)

Distal filter 520 (94.4%)

Distal balloon 23 (4.2%)

Flow reversal 8 (1.4%)

RISCPreliminary Results

• Carotid dissection 3 (0.5%)

• Carotid occlusion 3 (0.5%)

• Aborted procedures 4 (0.6%)

• Surgical conversion 4 (0.6%)

RISCPreliminary Results

NON - NEUROLOGICAL COMPLICATIONS

RISCPreliminary Results

NEUROLOGICAL COMPLICATIONS18 (2.8%)

TIAs Strokes Neurological death

Total

With Brain Protection(551 cases)

5 6 112

2.17 %

Without Brain Protection(94 cases)

3 3 0 6

6.38%

Total 8 9 1 18

CASES LOST TO FOLLOW-UP

9 deaths (not related to procedure)

4 impossibility to contact the patient

2 lack of interest from the patient

IN CONCLUSION

CS is a relatively safe procedure in the prevention of brain embolisation from carotid bifurcation plaques.

Early neurological (TIA, Stroke, Deaths) complication rates match favourably with CEA.

Debris capturing devices are effective but do not absolutely provide total protection.

RISC WEB SITE

www.fondazionevillamaria.it