Date post: | 11-Jan-2016 |
Category: |
Documents |
Upload: | warren-booker |
View: | 215 times |
Download: | 0 times |
Francesco LiistroCardiovascular Department, Arezzo, Italy
Impact of Thrombus Aspiration on Myocardial Tissue Reperfusion and Left Ventricular Functional
Recovery and Remodeling after Primary Angioplasty
BACKGROUNDBACKGROUND
Mounting interest has emerged regarding the role of distal embolization as a major determinant of impaired myocardial perfusion after primary PCI
Previous trials have shown the feasibility of thrombus aspiration during primary PCI and its impact on outcome
However, whether improvements in myocardial reperfusion with thrombus aspiration are directly connected to better follow-up left ventricular function and geometry, features which are strongly related to short and long-term mortality, has not been clarified so far
Mounting interest has emerged regarding the role of distal embolization as a major determinant of impaired myocardial perfusion after primary PCI
Previous trials have shown the feasibility of thrombus aspiration during primary PCI and its impact on outcome
However, whether improvements in myocardial reperfusion with thrombus aspiration are directly connected to better follow-up left ventricular function and geometry, features which are strongly related to short and long-term mortality, has not been clarified so far
Single center, prospective, randomized studyConsecutive patients with ST elevation acute MI
Primary endpoint: ST-segment elevation resolution (STR)
Secondary endpoints: TIMI Myocardial Perfusion Grade (TMPG) TIMI grade flow Corrected TIMI Frame Count (cTFC) Contrast enhancement by intracoronary myocardial contrast echo
(MCE) Persistent ST-segment deviation Time-course of wall motion score index, LV ejection fraction and
volumes
METHODS METHODS
Inclusion Criteria• symptoms suggesting acute myocardial ischemia
lasting more than 30’ • onset of symptoms < 12 hours • ST-segment elevation > 0.1 mV in two or more leads
Exclusion criteria• rescue PCI after thrombolysis• absence of an optimal echocardiographic apical view• life expectancy < 6 months
METHODS METHODS
111 Consecutive Patients with ST-segment elevation Myocardial Infarction within 12 hours of symptoms onset undergoing primary PCI
Patients
Randomization 1:1
PCI
Standard PCI(n=56)
EXPORT (Medtronic®)(n=55)
Angioplasty: TIMI flow gradecTFCTIMI Myocardial Perfusion GradeIntracoronary MCE
Evaluation of regional (WMSI) and global (EF) LV function and volumes (EDVI and ESVI) within 24 hoursECG (baseline, 90 min, 6 hours)
Post-PCI
Evaluation of regional (WMSI) and global (EF) LV function and volumes (EDVI and ESVI)Clinical follow-up for all patients
6-monthsFollow-Up
TRIAL FLOW CHARTTRIAL FLOW CHART
Control56 patients
N°(%) or M±SD
Export55 patients
N°(%) or M±SDP
value
Male sex 43 (77) 43 (78) >0.9
Age 65±11 64±11 0.7
Current smoker 36 (64) 35(63) >0.9
Diabetes 7(12) 11(20) 0.2
Family history of CAD 13 (23) 21 (38) 0.1
Hypertension 30 (53) 33 (60) 0.5
Hypercholesterolemia 17(30) 19(34) 0.6
History of CAD 2(4) 4(8) 0.1
Creatinine (mg/dL) 1.0±0.2 0.9±0.1 0.2
Killip Class ≥ 3 4(8) 2(4) 0.1
Symptom-onset-to-balloon time (min) 209±147 189±105 0.3
Symptoms-to-door time (min) 141.6±140.1 112.6±97.6 0.2
Door-to-balloon time (min) 75.9±38.7 75.7±33 >0.9
ST Segment elevation (mm) 8.1±5.4 8.5±5.8 0.7
ST Segment Deviation (mm) 11.6±7.9 12.7±7.8 0.5
Baseline clinical characteristicsBaseline clinical characteristics
Control56 patients
N°(%) or M±SD
Export55 patients
N°(%) or M±SD P value
Multivessel disease 21(40) 26(47) 0.4
Infart Related Artery (IRA):
LAD 26 (46) 21 (38) 0.1
CX 7(13) 6(11) 0.2
RCA 23(41) 28(51) 0.1
Lesion length (mm) 13.3±5.5 13.2±4.5 0.9
RVD (mm) 2.97±0.44 2.97±0.38 0.9
Basal MLD (mm) 0.03±0.14 0.01±0.06 0.2
Final MLD (mm) 2.86±0.6 2.91±0.4 0.1
Baseline TIMI-0-1 43(76) 38(69) 0.4
Stented patients 56(100) 55(100) >0.9
Direct Stenting 5(9) 12(21) 0.1
Complete revascularization 35(62) 29(53) 0.3
Distal Embolization 14(25) 4(7) 0.01
Final TIMI 3 46(82) 53(96) 0.02
Corrected TIMI Frame Count 25.9±12.4 21.6±9.7 0.04
Angiographic no reflow 10(18) 2(4) 0.02
Angiographic and Procedural CharacteristicsAngiographic and Procedural Characteristics
Time Course of Changes in Left Ventricular Ejection Fraction in the two study groups
RESULTSRESULTS
*P value according to repeated-measures ANOVA
*p<0.0001
Time Course of Changes in Wall Motion Score Index in the two study groups
RESULTSRESULTS
*P value according to repeated-measures ANOVA
Time Course of Changes in Left Ventricular End Diastolic Volume Index in the two study groups
RESULTSRESULTS
*p=0.001
*P value according to repeated-measures ANOVA
Time Course of Changes in Left Ventricular End Sistolic Volume Index in the two study groups
RESULTSRESULTS
*p<0.001
*P value according to repeated-measures ANOVA
6-months clinical follow-up
Control56 patients
N°(%)
Export55 patients
N°(%) P value
Cardiac Death 0 1(2) 0.5
Re-Myocardial Infarction 3(5) 3(5) >0.9
Stent Acute Thrombosis 2(3.5) 1(1.8) >0.9
Ischemia Driven TLR 4(7) 4(7) >0.9
MACE 7(12) 8(14) 0.8
6-months re-admission for congestive HF 3(5) 0 0.2
RESULTSRESULTS
Manual thrombus aspiration in the setting of primary PCI improves myocardial reperfusion as assessed by myocardial blush, myocardial contrast enhancement by intracoronary MCE and ST-segment resolution.
The improvement in tissue-level perfusion is paralleled by a significant improvement in regional and global LV function and a significant reduction of LV remodeling at 6 months.
This study provides the pathophysiological missing link between thrombus removal, tissue level perfusion, LV remodeling and clinical outcome.
CONCLUSIONSCONCLUSIONS