jorge palazuelos icp en lesiones severamente calcificadas

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Page 1: Jorge palazuelos icp en lesiones severamente calcificadas
Page 2: Jorge palazuelos icp en lesiones severamente calcificadas

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

[email protected]

Page 3: Jorge palazuelos icp en lesiones severamente calcificadas

“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

Page 4: Jorge palazuelos icp en lesiones severamente calcificadas

• 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

Page 5: Jorge palazuelos icp en lesiones severamente calcificadas

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

Page 6: Jorge palazuelos icp en lesiones severamente calcificadas

“Preparation and debulking of the lesion with rotational atherectomy and special

balloons, cutting or scoring, may be useful in highly calcified, rigid ostial lesions”

Page 7: Jorge palazuelos icp en lesiones severamente calcificadas

• 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)

Page 8: Jorge palazuelos icp en lesiones severamente calcificadas

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.

Page 9: Jorge palazuelos icp en lesiones severamente calcificadas

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)

Page 10: Jorge palazuelos icp en lesiones severamente calcificadas

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.

Page 11: Jorge palazuelos icp en lesiones severamente calcificadas

“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”

Page 12: Jorge palazuelos icp en lesiones severamente calcificadas

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)

Page 13: Jorge palazuelos icp en lesiones severamente calcificadas

“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

Page 14: Jorge palazuelos icp en lesiones severamente calcificadas

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

Page 15: Jorge palazuelos icp en lesiones severamente calcificadas

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

Page 16: Jorge palazuelos icp en lesiones severamente calcificadas

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

Page 17: Jorge palazuelos icp en lesiones severamente calcificadas

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

Page 18: Jorge palazuelos icp en lesiones severamente calcificadas

• 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

Page 19: Jorge palazuelos icp en lesiones severamente calcificadas

• 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

Page 20: Jorge palazuelos icp en lesiones severamente calcificadas

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

Page 21: Jorge palazuelos icp en lesiones severamente calcificadas

“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

Page 22: Jorge palazuelos icp en lesiones severamente calcificadas

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”

Page 23: Jorge palazuelos icp en lesiones severamente calcificadas

Abordaje y preparación de la lesiónDOCTORS

Current status of… Rotational Atherectomy

27.5%

39.8%

Page 24: Jorge palazuelos icp en lesiones severamente calcificadas

¿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

Page 25: Jorge palazuelos icp en lesiones severamente calcificadas

Son malos resultados en la era previa al DES

Buena idea, pero…

DES vs BMS

Page 26: Jorge palazuelos icp en lesiones severamente calcificadas

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

Page 27: Jorge palazuelos icp en lesiones severamente calcificadas

“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

Page 28: Jorge palazuelos icp en lesiones severamente calcificadas

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

Page 29: Jorge palazuelos icp en lesiones severamente calcificadas

“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

Page 30: Jorge palazuelos icp en lesiones severamente calcificadas

“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%

Page 31: Jorge palazuelos icp en lesiones severamente calcificadas

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

Page 32: Jorge palazuelos icp en lesiones severamente calcificadas

Results

PTCA+ PES

* The intention to treat analysis revelead = angio success

** Overall strategy success

Page 33: Jorge palazuelos icp en lesiones severamente calcificadas

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

Page 34: Jorge palazuelos icp en lesiones severamente calcificadas

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

Page 35: Jorge palazuelos icp en lesiones severamente calcificadas

¿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

Page 36: Jorge palazuelos icp en lesiones severamente calcificadas

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

Page 37: Jorge palazuelos icp en lesiones severamente calcificadas

“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

Page 38: Jorge palazuelos icp en lesiones severamente calcificadas

• 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

Page 39: Jorge palazuelos icp en lesiones severamente calcificadas

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

Page 40: Jorge palazuelos icp en lesiones severamente calcificadas

• 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

Page 41: Jorge palazuelos icp en lesiones severamente calcificadas

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.

Page 42: Jorge palazuelos icp en lesiones severamente calcificadas

Registro de utilización de ROTABLATOR en

intervenciones coronarias en hospitales españoles

www.proyectowilma.com

REGISTRO ROTABLATORREGISTRO ROTABLATOR

¿Cuál es el presente…?

Page 43: Jorge palazuelos icp en lesiones severamente calcificadas

REGISTRO ROTABLATORREGISTRO ROTABLATOR

www.proyectowilma.com

Registro de utilización de ROTABLATOR en intervenciones coronarias en hospitales

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

Page 44: Jorge palazuelos icp en lesiones severamente calcificadas

REGISTRO REGISTRO ROTABLATORROTABLATOR

TIPOS DE PACIENTES: Clínica

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Registro de utilización de ROTABLATOR en intervenciones coronarias en hospitales

españoles

Page 45: Jorge palazuelos icp en lesiones severamente calcificadas

REGISTRO ROTABLATORREGISTRO ROTABLATOR

www.proyectowilma.com

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

Page 46: Jorge palazuelos icp en lesiones severamente calcificadas

REGISTRO REGISTRO ROTABLATORROTABLATOR

Datos Coronariografía (2)

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Registro de utilización de ROTABLATOR en intervenciones coronarias en hospitales

españoles

Page 47: Jorge palazuelos icp en lesiones severamente calcificadas

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)

Page 48: Jorge palazuelos icp en lesiones severamente calcificadas

REGISTRO ROTABLATORREGISTRO ROTABLATOR

www.proyectowilma.com

• 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

españoles

Page 49: Jorge palazuelos icp en lesiones severamente calcificadas

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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REGISTRO ROTABLATORREGISTRO ROTABLATOR

Page 50: Jorge palazuelos icp en lesiones severamente calcificadas

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

Page 51: Jorge palazuelos icp en lesiones severamente calcificadas

REGISTRO ROTABLATORREGISTRO ROTABLATOR

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

Page 52: Jorge palazuelos icp en lesiones severamente calcificadas

¿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.

Page 53: Jorge palazuelos icp en lesiones severamente calcificadas

POBA vs Cutting

¿Cuál es el futuro…?

Page 54: Jorge palazuelos icp en lesiones severamente calcificadas

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…?

Page 55: Jorge palazuelos icp en lesiones severamente calcificadas

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

Page 56: Jorge palazuelos icp en lesiones severamente calcificadas

¿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

Page 57: Jorge palazuelos icp en lesiones severamente calcificadas

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

Page 58: Jorge palazuelos icp en lesiones severamente calcificadas

¡¡ Gracias !!

[email protected]