jorge palazuelos icp en lesiones severamente calcificadas
TRANSCRIPT
Intervencionismo coronario en lesiones
severamente calcificadas
Jorge Palazuelos Molinero, MD, PhDHospital U. Central de la Defensa Gómez Ulla. Madrid
Casa del Corazón, 17 de septiembre de 2015
“The cardinal indication for plaque modification is the calcific lesion,
which, in the absence of plaque modification, confers an increased
likelihood of procedural failure, stent underdeployment, restenosis, and
major complications”
Moussa I et al. Am J Cardiol 2005;96:1242–7Tomey et al. J Am Coll Cardiol Intv 2014;7:345–53
Bangalore et al. Catheter Cardiovasc Interv 2011;77:22–8
Current status of… calcium during PCI
Rev Esp Cardiol. 2008;61:1103-4
• High rates of short-term procedural success (range 93.4% to 98.6%), superior to rates reported separately in the absence of preceding plaque modification– Moussa I et al. Circulation 1997;96:128–36.– Hoffmann R et al. Am J Cardiol 1998; 81:552–7.– Kiesz RS et al. Catheter Cardiovasc Interv 1999;48:48–53.
Current status of… calcium during PCI
Determining calcification severity •Angiography < IVUS for detection of calcification, but visible calcification on angiography predicts a larger arc of calcification on IVUS.•IVUS or OCT permits discrimination of superficial (near the intima–lumen interface) and deep (at the media/adventitia border) calcium
Moussa I. Am J Cardiol 2005; Mintz GS.Circulation 1995; Mehanna E. CircJ2013
Rev Esp Cardiol. 2009;62:585-6Rev Esp Cardiol. 2005;58:1197-206
Determining calcification severity •In practice, calcification severity is graded by qualitative assessment of angiography
– Severe calcification defined by radio-opacities noted without cardiac motion before contrast injection, generally involving both sides of the arterial wall.
– Moderate calcification defined by densities noted only during the cardiac cycle before contrast injection.
Moussa I. Am J Cardiol 2005. Mintz GS. Circulation 1995. Mehanna E. Circ J 2013
Current status of… calcium during PCI
“Preparation and debulking of the lesion with rotational atherectomy and special
balloons, cutting or scoring, may be useful in highly calcified, rigid ostial lesions”
• CB is designed to create discrete longitudinal incisions by a controlled dilatation.
• Theoretically reduces the force
needed to dilate an obstructive lesion compared with standard PTCA.
Current status of… Cutting Ballon (CB)
Current status of… Cutting Ballon (CB)• Efficacy of cutting balloon angioplasty for
lesions at the ostium of the coronary arteries.– Muramatsu T. J Invasive Cardiol 1999 Apr;11(4):201-6.
• Effectiveness of cutting balloon angioplasty for small vessels less than 3.0 mm in diameter– Muramatsu T. J Interv Cardiol 2002 Aug;15(4):281-6.
• Cutting balloon angioplasty for the prevention of restenosis: results of the Cutting Balloon Global Randomized Trial– Mauri L. Am J Cardiol 2002;90:1079-83.
• Cutting balloon angioplasty and stent implantation for aorto-ostial lesions: clinical outcome and 1y F-UP – Nassar H. Clin Cardiol 2009 Apr;32(4):183-6.
Current status of… Cutting Ballon (CB)
Mauri L et al. Am J Cardiol 2002;90:1079-83
Cutting Balloon Global Randomized Trial
•N = 1,238 (617 CB vs 621 PTCA)•Mean reference vessel diameter: 2.86 +/- 0.49 mm•Mean lesion length 8.9 +/- 4.3 mm• Procedural success: 92.9% vs 94.7% (p= 0.24)• Coronary perforations: 0.8% vs 0% (p= 0,03)•Primary EP (6m binary angiographic restenosis rate)31.4% for CB and 30.4% for PTCA (p = 0.75)•Freedom from TVR: 88.5% vs 84.6% (p= 0,04)•Outcomes (270 days) – MI: 4.7% vs 2.4% (p= 0,03)– Death: 1.3% vs 0.3% (p= 0.06)– MACE: 13.6 vs 15.1% (p= 0.34)
Current status of… Cutting Ballon (CB)
“CB did not reduce the rate of angiographic restenosis. CB
angioplasty should be reserved for difficult lesions in which controlled dilatation is believed to provide a better acute result compared with
PTCA alone”
• CB is designed to create discrete longitudinal incisions by a controlled dilatation.
• Theoretically reduces the force
needed to dilate an obstructive lesion compared with standard PTCA.
“Rotational atherectomy might technically be required in cases of tight and calcified lesions, to allow subsequent passage of
balloons and stents. There is a resurgence in the use of rotational atherectomy for
the purpose of optimal lesion preparation among patients undergoing implantation
of bioresorbable stents”
ISR 27-38% BMS
ISR 38% Rota alone DES
1st Published registry
Current status of… Rotational Atherectomy
2015, 332014, 292013, 322012, 282011, 232010, 222009, 172008, 152007, 162006, 172005, 23
1987 2015
Resultados por año (PubMed)
“The cardinal indication for rotational atherectomy is the calcific lesion, which, in the
absence of plaque modification, confers an increased likelihood
of procedural failure, stent underdeployment, restenosis,
and major complications”
Current status of… Rotational Atherectomy
Moussa I et al. Am J Cardiol 2005;96:1242–7Tomey et al. J Am Coll Cardiol Intv 2014;7:345–53
Bangalore et al. Catheter Cardiovasc Interv 2011;77:22–8
CORTE DIFERENCIAL
Elastic tissue is able to deflect out of the way
Elastic tissue space
Elastic tissue
deflects
Direction of motion
Diamond crystal
Inelastic tissue is unable to deflect out of the way
Inelastic tissue space
Direction of motionDiamond crystal
Forcefulmechanicalbreakdown
of matter
post-PTCApost-Rotablator®
Función: mov.circunferencial (mov. longitudinal + velocidad)Beneficios: avance del dispositivo en vasos
estrechos, tortusoso y calcificados.
Current status of… Rotational Atherectomy
Memoria histórica
• Rota feasability: NACI registry (1997)• Comparison of different debulking
strategies with POBA: ERBAC (1997)• Rota vs POBA: COBRA (2000), DART• Rota vs POBA before stenting: SPORT• Rota vs POBA in ISR: BARASTER (2000)• Technical/procedural questions:
STRATAS (2001)
Current status of… Rotational Atherectomy
Indications1) calcified lesions2) left main stenoses3) lesions in proximal/mid segments of
LAD/RCA4) circumflex with short trunk, or small angle
of origin5) ostial sites6) long length lesions7) smooth contour
Current status of… Rotational Atherectomy
Absolutes Contraindications1) Dissections2) Thrombus3) Slow-flow or no-flow4) impossibility of inserting the guidewire
RelativEs Contraindications1) vessel tortuosity2) angular lesions3) excessively calcified vessels4) vein graft disease
Current status of… Rotational Atherectomy
• AR ayuda a la correcta expansión del stent• Tan K et al. J Am Coll Cardiol 1995; 25: 855-65.• Hofmann R et al. Eur Heart J 1998; 19: 1224-31.• Furuicchi S et al. Eurointervention 2009; 5: 370-4.
• Beneficio clínico de la AR en el tratamiento de lesiones coronarias calcificadas
• Khattab. J Interv Cardiol 2007; 20: 100-6.• Kawaguchi. Cardiovasc Revasc Med 2008; 9: 2-8.• Mangiacapra F. Eurointervention 2010• Dardas P. Hellenic J Cardiol 2011; 52: 399-406.• Benezet J. J Invasive Cardiol 2011; 23: 28-32.
• AR en TCI• Garcia-Lara et al. Catheter Cardiovasc Interv 2011,
Nov 25
Aposición y expansión del stentCurrent status of… Rotational
Atherectomy
• Lesiones calcificadas y fibróticas suponen en sí mismas un desafío
• Alteraciones del dispositivo• liberación, daño recubrimiento y/o
polímero• Fracaso en el implante • infraexpansión del stent y malaposición:
RIS y TS
¿Y esto importa¿Y esto importa…?…?Aposición y expansión del stent
Current status of… Rotational Atherectomy
a. Infraexpansión: morfología elíptica del stent (calcio superficial) con flap de la íntima.
b. Malaposición: intimal tear (rama lateral?)
Aposición y expansión del stent
Tanigawa J. Circ J 2008; 72: 157-60.
Current status of… Rotational Atherectomy
“OCT clearly showed how HCL behave when treated with PTCA or RA. It is a challenge to achieve optimal stent expansion and strut apposition but is necessary to realize the
full benefit of DES”
Current status of… Rotational AtherectomyAposición y expansión del stent
ROTABLATOR and RESTENOSIS STUDY (R&R)• Diseño
100 pt (103 lx); B/C lx: 85%; escalonado; b/a ratio 0.65-0.75;• Complicaciones
–CABG 1%, qMI and death 0%, non-qMI 3%–6 month F/U: 15% clinical, 28% angiographic RS
“RS may be mediated by deep wall trauma. RA removes atherosclerotic plaque without disruption
of the internal elastic lamina avoiding deep wall trauma”
Braden, oral presentation, TCT 2000
Abordaje y preparación de la lesiónCurrent status of… Rotational
Atherectomy
“RA with a moderately aggressive debulking followed by low pressure BA is associated
with excellent results, low stent implantation and RS rates”
Abordaje y preparación de la lesiónDOCTORS
Current status of… Rotational Atherectomy
27.5%
39.8%
¿BMS vs DES? ¿Importa? •It is unclear whether RA improves outcomes with DES.•In theory, preparation of a smooth cylindrical lumen might facilitate superior stent deployment and reduced restenosis. This benefit has not yet been shown.•Results are inconsistent in observational studies and difficult to interpret because of selection biases in RA assignment (calcification, disease severity), which may influence outcomes.•Long-term benefit was again absent in the recent ROTAXUS study
Current status of… Rotational Atherectomy
Son malos resultados en la era previa al DES
Buena idea, pero…
DES vs BMS
ROTA+BMS y ROTA-DES es lo ROTA+BMS y ROTA-DES es lo mismo…?mismo…?
Khattab AA et al. J Interv Cardiol. 2007; 20 (2): 100-6
DES vs BMS
“Rotational atherectomy in the drug-eluting stent era: a single-centre
experience”• 158 pt (236 lesiones): DES, BMS, no stent• DES:112 pt,158 lx / BMS:19 pt,28 lx / NS: 27 pt,50
lx• Éxito inicial: 96.4%• Indicación de AR
• Primera elección: 84%;• Bail-out: 16%• Preservar rama lateral: 25%• Debulking CTO: 5.5%• RIS: 3%
• DES no fue implantado en 46 pt (23%) por diámetro de referencia < 2.25 o > 3.75 mm
Schwartz BG et al. J Invasive Cardiol 2011; 23: 133-9.
Rota + BMS TLR 22.5%
Rota + DES TLR 10.2%
vs
DES vs BMS en lesiones complejas
Dardas P. Hellenic J Cardiol 2011; 52: 399-406.
Vaso tratado
Tasa de MACCE (%)• Rota+DES >
Rota+BMS• Rota+ACTP no mejor
ACTP: TLR 40%
N = 184Tipo de lesión
“Rotational atherectomy in drug eluting stent era”
DES vs BMS
Parece que NO ES LO MISMO
Rathore et al. Catheter Cardiovasc Interven 2010;75:919-27
“Rotational atherectomy in drug eluting stent era” • MACE: 2.9%; QMI: 1.3%; nQMI: 5.3%;
UPCI:0.4%• DES vs BMS: RR 50% at 6-9m• B.restenosis: 11 vs 28% (p = 0,001)• TLR: 10.6 vs 25% (p < 0.001)
Rathore et al. Catheter Cardiovasc Interven 2010;75:919-27
Current status of… Rotational Atherectomy
IVUS: 96.5%
240 patients con seguimiento intrahospitalario completo
Seguimiento angiográfico a 9 meses
in 80.5% (N=190)
Seguimiento clínico a 9 meses en 96.2%
(N=227)
1:1 randomizacion
PTCA + PES(N=120)
Rota + PES(N=120)
- 2 patients muerte intra-hosp- 6 patients renegaron consent- 5 patients pérdidos en seg
240 patientes randomizados entre Agosto de 2006 y Marzo de 2010 de 3 únicos centros en Alemania
Pero no todo es tan bonito
Abdel-Wahab M, et al. Catheter Cardiovasc Interv 2013
Results
PTCA+ PES
* The intention to treat analysis revelead = angio success
** Overall strategy success
Rota + PES
n = 123
PTCA + PES
n = 132P
ValueBefore procedure Lesion length (mm) 19.56±9.64 18.63±9.70 0.44 Reference vessel diameter (mm) 2.67±0.41 2.77±0.37 0.04 Minimal lumen diameter (mm) 1.01±0.36 1.10±0.39 0.05 Diameter stenosis (%) 62.05±11.92 60.18±12.74 0.17
Immediately after procedure Minimal lumen diameter (mm) In-stent 2.58±0.37 2.56±0.40 0.61 In-segment 2.27±0.50 2.27±0.49 0.98 Diameter stenosis (%) In-stent 10.43±5.25 11.82±5.21 0.03 In-segment 17.68±8.98 19.38±16.67 0.18 Acute gain (mm) In-stent 1.57±0.43 1.46±0.46 0.03 In-segment 1.26±0.54 1.17±0.53 0.18
QCA data: Index procedure
p = 0.01 QCA data:
9mo Stent-LLL
ROTAXUS study limitations•missing angiographic FUP in 1 in 5 patients•insufficient power to compare clinical outcomes•a preponderance of moderately calcified lesions•confounding factors in the RA group
– Crossover: 4.2 vs 12.3%– longer lesion length– lower maximum predilation balloon pressure
¿BMS vs DES? ¿Importa? •Prior studies: RA+PTCA+BMS
– Tran T. Catheter Cardiovasc Interv 2008;72:650–62
•Today, DES account for most implanted stents
– Krone RJ. J Am Coll Cardiol Intv 2010;3:902–10
•DES > BMS– improved outcomes after RA– intermediate and long-term outcomes– MACE are lower with DES compared with BMS – TLR < 10% within 1-2 years– This is consistent with broader trials of DES vs
BMS and propensity matched comparison of DES vs BMS in pt with calcified lesions
Current status of Rotational Atherectomy
Definitivamente NO ES LO MISMO
RA facilitates procedural success in complex PCI
– B2/C type lesions (ACC/AHA) • Levin TN. Cathet Cardiovasc Diagn 1998;45:122–30.• Reifart N. Circulation 1997;96:91–8.
– Ostial lesions • Tan RP. Catheter Cardiovasc Interv 2001;54:283–8. • Koller PT. Cathet Cardiovasc Diagn 1994;31:255–60.• Zimarino M. Cathet Cardiovasc Diagn 1994;33:22–7.
– Bifurcation lesions• Main vessel:
– Karvouni E. Catheter Cardiovasc Interv 2001;53:12–20.– Tsuchikane E. J Am Coll Cardiol 2007;50:1941–5.
• Side-vessel: – Nageh T. Cardiology 2001;95:198–205. – Ito H. J Invasive Cardiol 2009;21:598–601.
– CTO• Tsuchikane E. Int J Cardiol 2008;125:397–403.
Current status of… calcium during PCI
“Preparation and debulking of the lesion with RA and special balloons, cutting or
scoring, may be useful in highly calcified, rigid ostial lesions”
Current status of RA… in Ostial Disease
• In ostial coronary lesions, caution is essential before proceeding to PCI– Coronary spasm (has to be absent)– Severity: FFR may be valuable in borderline lesions– In ostial LAD/LCx stenoses
a decision must be made on whether to attempt precise positioning of the stent at the ostium of the artery or whether stenting across the LCx/LAD ostium into the LM artery is preferable.
• Assessment with IVUS/OCT may be helpful
• In the current DES era, RA has largely been supplanted by: BA, DEB, CB, DES, CABG
• Benefits of RA, when used for ISR, likely depend on the mechanism of restenosis– is most beneficial for removal intimal
hyperplasia and less effective for radial expansion of an underexpanded stent
• If RA is contemplated for use in DES ISR, pre-treatment imaging with IVUS or OCT may be warranted to first elucidate the mechanism of restenosis
Dangas GD. J Am Coll Cardiol 2010;56:1897–907
Current status of RA… in ISR
Current status of RA… in ISR
Sharma SK (ROSTER). Am Heart J 2004. Vom Dahl J (ARTIST). Circulation 2002
In-stent restenosis (ISR): ROTA vs POBAROSTER (Randomized Trial of Rotational Atherectomy Versus Balloon Angioplasty for Diffuse In-Stent Restenosis)
200 pt with IVUS confirmed diffuse ISRRA (intimal hyperplasia area): reduction in repeat
stenting (10% vs. 31%, p< 0.001) and TLR (32% vs. 45%, p= 0.042) at 12m of FUP
ARTIST trial (Angioplasty Versus Rotational Atherectomy for Treatment of Diffuse In-Stent Restenosis)
RA (stent expansion): higher incidence of binary restenosis (65% vs. 51%, p=
0.039) at 6m (radial expansion of an underexpanded stent)
BENEFIT
NO BENEFIT
• 159 pt. BMS• Diámetro de referencia 2.36±0.49 mm
• Reestenosis rate: 44.2% y TLR 33%• Late loss 0.55±0.69 mm J Interven Cardiol 2003;16: 315-22
VASOS PEQUEÑOS
Clinical experience with rotational atherectomy in patients with severe left
ventricular dysfunction• N = 23 (17 hombres) / FEVI media: 21.3% • Éxito inicial: 100%• Eventos:
• Mortalidad intrahospitalaria: 4.3% (r/AR: 0%)• Infarto periprocedimiento: 13% (3 pt) • MACE 30 días: 0%
“The transient effect of RA on ventricular function did not adversely affect short-term
outcomes in our study population. These results suggest that RA, when performed by experienced operators, is safe and feasible
in patients with severe LV dysfunction”Ramana RK. J Invasive Cardiol. 2006
Nov;18(11):514-8.
Registro de utilización de ROTABLATOR en
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¿Cuál es el presente…?
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españoles Age (mean; SD) 74.9 (8.7)GenderMale (n = 511)Female (n = 167)
75.424.6
Weight (mean; SD) 76.1 (14.2)Height (mean; SD) 164.5 (9.6)Body Mass Index (mean; SD) 28.6 (12)Tobacco (%) 53.1HTA (%) 83.7Diabetes mellitus (%) 53.1Dyslipidemia (%) 70.7LVEF ≤ 44% (%) 27.3Moderate/severe mitral regurgitation (%) 21.2
Prior Myocardial Infarction (%) 30.4Prior PCI (%) 31.1Prior CABG (%) 10.3Prior Stroke (%) 11.4Renal dysfunction (%) 28.9Peripheral vascular disease (%) 24.6
Características
demográficas y clínicas basales
REGISTRO REGISTRO ROTABLATORROTABLATOR
TIPOS DE PACIENTES: Clínica
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Registro de utilización de ROTABLATOR en intervenciones coronarias en hospitales
españoles
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Registro de utilización de ROTABLATOR en intervenciones coronarias en hospitales
españoles Sheath, 6F (%) 57.9
Approach (%)
Radial artery 56
Femoral artery 44
Co-adjuvant therapy (%)
Heparin 90.9
Bivaluridine 9.3
GP inhibitors 7.1
Right dominance (%) 92.2
Multivessel disease (≥2) (%) 62
Left Main LAD LCX RCA Prevalence of disease (n, %) 93 (13.7) 493
(72.7) 321 (47.3) 416 (61.4)
Nº Lx 1 (.2) 1.6 (.8) 1.4 (.6) 1.5 (.7)
Lx length 12 (4.5) 27.9 (16.2) 21.5 (13.4) 28.1 (18.6)
Diameter 3.7 (.5) 2.8 (.4) 2.6 (.5) 3 (.6)
Treated with RA [n (%)] 63 (9.9) 382 (60.1) 89 (14) 191 (30.7)
Características angiográficas basales
REGISTRO REGISTRO ROTABLATORROTABLATOR
Datos Coronariografía (2)
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Registro de utilización de ROTABLATOR en intervenciones coronarias en hospitales
españoles
REGISTRO ROTABLATORREGISTRO ROTABLATOR
Registro de utilización de ROTABLATOR en intervenciones coronarias en hospitales
españoles ICP
Wire Left Main LAD LCX RCA
Type [n (%)] Floppy 584 (80.1) 51 (81) 316 (82.7) 71 (79.8) 146 (74.9) Support 145 (19.9) 12 (19) 66 (17.3) 18 (20.2) 49 (25.1) Advance [n (%)] Directly 321 (44) 38 (60.3) 174 (45.5) 40 (44.9) 69 (35.4) OTW-B 143 (19.6) 9 (14.3) 80 (20.9) 16 (18) 38 (19.5) Microcatheter 265 (36.4) 16 (25.4) 128 (33.5) 33 (37.1) 88 (45.1)Burr Advance [n (%)] Directly 550 (79.5) 54 (85.7) 293 (81.2) 59 (70.2) 144 (78.3) Predilated 142 (20.5) 9 (14.3) 68 (18.8) 25 (29.8) 40 (21.7) Burr number [n (%)] ≤ 1 601 (83.5) 53 (84.1) 314 (82.2) 73 (82) 161 (82.6) ≥ 2 119 (16.5) 10 (15.9) 64 (16.8) 13 (14.6) 32 (16.4) Burr size [n (%)] ≤ 1.5 mm 645 (92.2) 54 (85.7) 346 (91.5) 78 (90.7) 167 (86.5) ≥ 1.75 mm 54 (7.8) 5 (50) 23 (35.9) 6 (46.2) 20 (62.6) Speed (rpm) (M; SD) 164724
(14948)164772(15237)
163884(15400)
165392(14564)
164848(14594)
PTCA post RA [n (%)] 670 (91.2) 56 (88.9) 351 (91.9) 81 (91) 182 (93.3) Compliant Ballon 37 (50.3) 23 (41.1) 171 (48.7) 50 (61.7) 93 (51.1) Non-Compliant B 333 (49.7) 33 (58.9) 180 (51.3) 31 (38.3) 89 (48.9)Stent 725 63 (8.6) 382 (52.6) 89 (12.2) 191 (26.3) Type (n, %) Bare metal stent 139 (19.1) 11 (11.7) 47 (12.8) 20 (23.5) 61 (31.9) Drug-eluting stent Limus 476 (65.6) 46 (74.2) 268 (73) 52 (61.2) 110 (57.6) Taxol 90 (12.4) 5 (8.1) 52 (7.7) 13 (15.3) 20 (10.5) Diameter (Me, ICA) (mm) 3.1 (1.9) 3.5 (.2) 2.8 (2.5) 2.9 (2.2) 3.2 (2.7) Length (Me, ICA) (mm) 25 20.7 (29) 27.3 (89) 25.2 (52) 27.1 (79)
REGISTRO ROTABLATORREGISTRO ROTABLATOR
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• Guía más usada: La normal: floppy• Acceso directo bastante frecuente, incluso en la coronaria
derecha• IVUS (7,9%): TCI: 2,2%, DA: 4,1%, CX: 0,7% y CD: 0,9%
VasoUso de
una oliva (%)
Oliva más usada (%)
Intercambio guía tras rotablator
% ACTP-Balón
postRota
% Balón NO
compliat.
Stent más
utilizado
% Postdilat
.
TC 81,6% 1,5 (44,9%) 75,5% 85,7% 59,5 Limus
(77,1%) 75%
DA 84% 1,5 (49,1%) 72,5% 90,2% 49% Limus
(73,5%) 54,5%
CX 81,7% 1,5 (50%) 76,1% 91,5% 0% Limus 61,2%) 50,7%
CD 81,6% 1,5 (50%) 80,9% 94,9%43,4%
CuttingB (20,2%)
Limus (57,8%) 51,9%
Rotablación: otras cuestiones técnicas
Registro de utilización de ROTABLATOR en intervenciones coronarias en hospitales
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Éxito clínicoSí: 97,1% (663)No: 2,9% (15)
Muerte: 6 (0,8%)I.Rn.A: 1 (fallece a los 5 días)No flow: 2 (disfunción VI severa; EAP basal)Perforación: 2EAP: 1
Infarto: 11 (1,6%)Perdida de rama lateral: 3
recuperada: 2 (1 con síntomas)no recuperada: 1 (síntomas)
Asintomático (elevación enzimática): 9Otros:
EAP: 2 (0,2%)AIT: 2 (0,2%)HIC: 1 (0,1%) www.proyectowilma.
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Éxito angiográficoSí: 95,9% (650)No: 4,1% (28)
Relacionado con el procedimiento: 21 (3%)Imposibilidad procedimiento: 8 (1,1%)
Fallo avance guía y/o balón: 6Fractura de stent: 1Perdida de stent: 1
Disección coronaria: 6 (0,8%)Perforación coronaria: 3 (0,4%)Taponamiento cardiaco: 2 (0,29%)Pérdida de rama lateral: 1 (0,14%)Trombosis subaguda: 1 (0,14%)
Relacionado con rotablator: 7 (1%)Fallo avance guía y/o oliva: 2 (0,29%)Atrapamiento oliva: 2 (0,29%)Pérdida de rama lateral: 2 (0,29%)Disección: 1 (0,14%) www.proyectowilma.
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REGISTRO ROTABLATORREGISTRO ROTABLATOR
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Time (days)
0 7 30 180 270 365 540 730 1132
Population
678 609 581 478 410 348 158 90 0
Events 2 6 7 10 11 12 21 25 28
Supervivencia acumulada libre de MACE
Time (days)
0 3 40 157
159
373
411
425
685
706
724
727
Population
625 601
553
480
477
322
263
250
108
98 91 90
Events 1 2 3 4 5 6 7 8 9 10 11 12
IC 95%: 1100 (1081 – 1118)
days
IC 95%: 1049 (1016 – 1083)
days
Supervivencia acumulada
libre de Muerte
¿Cuál es el futuro…? CONSENSO EUROPEO
The aim… to a standardized protocol on the correct performance of rotational
atherectomy… in training programmes and in daily procedures, and… to correct the erroneous perception of rotational
atherectomy as an exclusive technique.
POBA vs Cutting
¿Cuál es el futuro…?
POBA vs CuttingHipótesis: ROTACUT > ROTAPOBA before DES.Métodos: IVUS/OCT en los casos de AR.Endpoint: Min stent CSA; Min stent MLD; Acute gain
ROTA-LIMUSHistoria: > ganancia aguda con AR; peor LLL: con PES LLL 0.4mm (ROTAXUS)Hipótesis: DES (limus) última generación.
Métodos: IVUS/OCT
Endpoint: Eficacia (IVUS/OCT): In-stent LLL 9m
¿Cuál es el futuro…?
Hipothesis: AR no inferior a técnica convencionalMethods: Medina lesions: 1,0,0 / 1,1,0 / 0,1,0Primary Endpoint
MACE: death, infarction, repeat revascularization (target vessel revascularization), urgent surgery requirement; their combination and mortality due any cause. Secondary endpoints
A) angiographic outcomes:a. success rate periprocedure and yearly
check-up.b. angiographic complications rate.
B) clinical variables: prevalence of MACE. As well the incidence of stroke, haemorrhages with or without the need for transfusion, renal insufficiency.
¿Cuál es el futuro…? BIFURCATOR
¿Qué CONCLUSIONES podemos sacar?
• AR logra en lesiones complejas mejores éxitos clínicos y angiográficos (+ baratos??) que la ICP convencional a corto-medio y largo plazo
• Queda mucho por saber: – IVUS / OCT– SBO, Rotacut, R-Limus...
• Indicaciones:– Calcificación– TCI– Ostial– Bifurcaciones
- “Indilatables”- Lesiones largas- CTO- Vasos pequeños- ISR
Current status of… calcium during PCI
Modificado de Tomey et al. J Am Coll Cardiol Intv 2014;7:345–53
Current status of… calcium during PCIPCI
Angiographic calcification
Moderate SevereMild
IVUS / OCT
Rotational Atherectomy
strategy
Non-Rotational
Atherectomy strategy
Mild Severe
ostial/Bf/small/diffuse
¡¡ Gracias !!