scarica abstract in powerpoint
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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
Transcript of scarica abstract in powerpoint
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
