SYSTEMATIC MANUAL THROMBUS ASPIRATION: PRO
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1 SYSTEMATIC MANUAL THROMBUS ASPIRATION: PRO FRANCESCO BURZOTTA INSTITUTE OF CARDIOLOGY CATHOLIC UNIVERSITY OF THE SACRED HEART ROME, ITALY CONTROVERSIES IN PRIMARY PERCUTANEOUS CORONARY INTERVENTION ESC Congress 2011 August 29 th 2011, Paris
2 DECLARATION OF CONFLICT OF INTEREST I have been involved in advisory meetings by Medtronic
3 Why to speak about manual thrombus-aspiration?
4 NO REFLOW IS COMMON IN STEMI PTS!!! See TIMI flow See BLUSH See ST segment optimal reperfusion Niccoli, Burzotta, Galiuto, Crea. No reflow in man. JACC 2009
5 NO REFLOW IS CLINICALLY RELEVANT!!! Sorajja et al. CADILLAC substudy, EHJ 2005
6 thus, the tough war against no-reflow started
7 MECHANISMS OF NO-REFLOW WHICH MAY BE TARGETED BY THERAPIES Niccoli, Burzotta, Galiuto, Crea. No reflow in man. JACC 2009
8 DISTAL EMBOLIZATION DURING STANDARD PCI IN STEMI
9 DISTAL EMBOLIZATION DURING STANDARD PCI IN STEMI Doppler-wire evaluation of embolization during standard primary PCI in 37 pts Balloon pre-dilation Stent Implantation Balloon post-dilation Okamura et al. JACC Intv 2008
10 TYPES OF MECHANICAL INTERVENTIONS TO PREVENT DISTAL EMBOLIZATION Proximal protection Distal protection Thrombectomy
11 Tested in trials NON-MANUAL THROMBECTOMY THROMBECTOMY: TYPES OF DEVICES MANUAL THROMBUS-ASPIRATION The aspiration force comes from an electrical engine Eventually, the extraction power is enhanced by systems which may cut or mobilize athero-thrombotic material from the vessel wall The aspiration force comes from a simple syringe The device is basically a simple tube RESCUE ANGIOJET X-SIZER TVAC
12 Tested in trials NON-MANUAL THROMBECTOMY THROMBECTOMY: TYPES OF DEVICES MANUAL THROMBUS-ASPIRATION The aspiration force comes from an electrical engine Eventually, the extraction power is enhanced by systems which may cut or mobilize athero-thrombotic material from the vessel wall The aspiration force comes from a simple syringe The device is basically a simple tube RESCUE ANGIOJET X-SIZER TVAC
13 MANUAL THROMBUS-ASPIRATION: THE FIRST TRIAL ON NO-REFLOW PREVENTION late breaking clinical trial session of EuroPCR 2005; published in JACC 2005
14 MANUAL THROMBUS-ASPIRATION: THE LARGEST TRIAL ON NO-REFLOW PREVENTION NEJM 2008
15 THROMBUS-ASPIRATION TO PREVENT NO-REFLOW: THE ESC GUIDELINES
16 THROMBUS-ASPIRATION TO SAVE LIFES If we apply this technique which reduces no-reflow will we reach the final goal of improving survival?
17 THROMBUS-ASPIRATION TO SAVE LIFES: THE TAPAS TRIAL TAPAS TRIAL: 1 year 12 Conventional PCI Thrombus-Aspiration 10 Mortality (%) Time (days) Vlaar PJ et al, Lancet 2008
18 CUMULATIVE SURVIVAL THROMBUS-ASPIRATION TO SAVE LIFES: THE TRIALS POOLED RESULTS (ATTEMPT) 100% P= % 90% Thrombectomy Standard PCI 85% 80% No previous report on outcome >1 year 300 days 600 days 900 days 1200 days TIME TO DEATH Hotline session of ESC 2009; published in EHJ 2009
19 THROMBUS-ASPIRATION TO SAVE LIFES: THE TRIALS POOLED RESULTS (ATTEMPT) NON- MANUAL THROMBECTOMY TRIALS MANUAL ASPIRATION TRIALS 100% CUMULATIVE SURVIVAL 100% CUMULATIVE SURVIVAL 95% 95% 90% 90% P= P= % 80% 85% 80% Estimated number of pts to treat to save 1 life: days 600 days 900 days 1200 days 300 days 600 days 900 days 1200 days Hotline session of ESC 2009; published in EHJ 2009
20 THROMBUS-ASPIRATION TO SAVE LIFES: THE ACC/AHA GUIDELINES
21 thus, the tough war against no-reflow started
22 WHAT SHOULD WE DO WITH THROMBUS ASPIRATION?
23 Why to speak about routine vs. selective use of manual thrombus-aspiration?
24 CONCERNS REGARDING SYSTEMATIC THROMBUS ASPIRATION USE it would be ideal to apply a therapy only in those patients who may benefit from it Device not able to reach/cross the lesion Thrombus aspiration performed but no material is retrieved All STEMI patients Thrombus aspiration performed, aspirate retrieved modified from Limbruno
25 CONCERNS REGARDING SYSTEMATIC THROMBUS ASPIRATION USE Device not able to reach/cross the lesion STEMI pts
26 FAILURES TO REACH/CROSS THE TARGET LESION Vink et al, JACC Intv 2011
27 FAILURES TO REACH/CROSS THE TARGET LESION Vink et al, JACC Intv 2011
28 FAILURES TO REACH/CROSS THE TARGET LESION Vink et al, JACC Intv 2011
29 FAILURES TO REACH/CROSS THE TARGET LESION thrombus aspiration catheters: a growing family
30 FAILURES TO REACH/CROSS THE TARGET LESION thrombus aspiration catheters: a growing family
31 CONCERNS REGARDING SYSTEMATIC THROMBUS ASPIRATION USE Thrombus aspiration performed but no material is retrieved All STEMI patients
32 FAILURES TO ASPIRATE THROMBUS/ATHEROMA rate of effective aspiration in TAPAS trial according to the operator 80% 75% 60% 40% 20% #1 #2 #3 #4 #5 #6 Vlaar et al. EuroIntervention 2011
33 FAILURES TO ASPIRATE THROMBUS/ATHEROMA Rate of optimal angiographic reperfusion (MBG 3) 40% 44% 35% 30% 20% 10% 3 operators with >75% of effective aspiration 3 operators with <75% of effective aspiration Vlaar et al. EuroIntervention 2011
34 LOOKING FOR AN OPTIMAL TECHNIQUE PI: G. Guagliumi STEMI (1:1 men and women) PATIENTS UNDERGOING PRIMARY PCI thrombus aspiration OCT PCI with DES OCT after PCI and at FU THROMBUS ASPIRATION SUBSTUDY: assessment of optimal technique to achieve low thrombus burden after thrombus aspiration
35 CONCERNS REGARDING SYSTEMATIC THROMBUS ASPIRATION USE Thrombus aspiration performed but no material is retrieved All STEMI patients
36 CONCERNS REGARDING SYSTEMATIC THROMBUS ASPIRATION USE Are these thrombus aspirations useless? Thrombus aspiration performed but no material is retrieved All STEMI patients
37 ARE FAILURES TO ASPIRATE THROMBUS/ATHEROMA USELESS?
38 ARE FAILURES TO ASPIRATE THROMBUS/ATHEROMA USELESS?
39 ARE FAILURES TO ASPIRATE THROMBUS/ATHEROMA USELESS? Suzuki et al. Eur J Clin Investigation 2008
40 ARE FAILURES TO ASPIRATE THROMBUS/ATHEROMA USELESS? Funajama et al. Int J Cardiol 2010
41 ARE FAILURES TO ASPIRATE THROMBUS/ATHEROMA USELESS? Porto et al. Submitted
42 CONCERNS REGARDING SYSTEMATIC THROMBUS ASPIRATION USE All STEMI patients Thrombus aspiration performed, aspirate retrieved
43 AMOUNT OF ASPIRATED MATERIAL IS HIGHLY VARIABLE!!!
44 EXTREMES IN THE VARIABILITY OF RESPONSE TO THROMBUS ASPIRATION Talarico et al. J Invasive Cardiol 2010
45 EXTREMES IN THE VARIABILITY OF RESPONSE TO THROMBUS ASPIRATION
46 CAN WE SELECT THOSE PATIENTS WITH NO BENEFIT FROM MANUAL THROMBUS ASPIRATION? Risk of reperfusion in TAPAS trial according to the pre PCI characteristics Svilas et al. NEJM 2008
47 CAN WE SELECT THOSE PATIENTS WITH NO BENEFIT FROM MANUAL THROMBUS ASPIRATION? Images by Porto
48 CONCLUSIONS ON THE BASIS OF THE ACCUMULATED SCIENTIFIC DATA (WELL RECEIVED BY INTERNATIONAL PRACTICE GUIDELINES) AND IN THE ABSENCE OF RELIBLE MARKERS/PREDICTORS OF RESPONSE TO THROMBUS ASPIRATION MANUAL THROMBUS ASPIRATION SHOULD BE ROUTINELY PERFORMED IN PRIMARY PCI!!!
49
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