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Thrombus aspiration plus Mguard mesh covered stent for treatment of ST-segment elevation myocardial infarction
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Abstracts / Cardiovascular Revascularization Medicine 13 (2012) e3–e19
Marco L. Rossi, Guido Belli, Patrizia Presbitero Istituto Clinico Humanitas IRCCS, Rozzano (Milan), Italy Background: The predictive value of admission C-reactive protein (CRP) for long-term outcomes in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) is controversial. Methods: Consecutive patients with STEMI undergoing primary PCI in a single tertiary cardiac center were enrolled. High-sensitivity CRP was measured by immunonephelometric method before coronary angiography on admission. Cox regression analysis was performed to calculate hazard ratios (HR) of events with 95% confidence intervals (CI). Results: A total of 449 patients, 65.4 (55.9 ± 73.8) yrs old, 322 (71.7%) males, were enrolled. Baseline CRP levels were significantly higher in patients who died (N = 57) compared to those who remained alive [0.8 mg/dl (25th–75th percentile, 0.3–5.9 mg/dl) vs. 0.4 mg/dl (25th–75th percentile, 0.2–0.9 mg/dl), P b.001], and in patients experiencing the composite of death, non fatal myocardial infarction, target lesion or vessel revascularization, and hospitalization for heart failure (i.e. MACEs) (N = 140) compared to those without MACEs [0.52 mg/dl (25th–75th percentile, 0.27–2.72 mg/dl) vs. 0.39 mg/dl (25th–75th percentile, 0.2–0.8 mg/dl), P = .0001]. At multiple Cox regression analysis at a median follow-up of 1048 days (25th–75th percentile, 839–1334 days), CRP levels, as continuous variable, and top quartile CRP levels (i.e. CRP ≥1 mg/dl) were significant predictors of mortality [HR 1.09, 95% CI (1.05–1.13), b0.001; and HR 2.85, 95% CI (1.59–5.13), P b.001, respectively], and of MACEs [HR 1.06, 95% CI (1.03–1.09), P b.001), and HR 1.96, 95% CI (1.36–2.83), P b.001, respectively]. Conclusions: High levels of baseline systemic CRP are an independent predictor of mortality and of MACEs at long-term follow-up in patients undergoing primary PCI.
doi:10.1016/j.carrev.2012.01.040
Thrombus aspiration plus Mguard mesh covered stent for treatment of ST-segment elevation myocardial infarction Rafael Romaguera, Joan Antoni Gomez-Hospital, Guillermo Sanchez-Elvira, Josep Gomez-Lara, Gerard Roura, Jose Luis Ferreiro, Silvia Homs, Luis Teruel, Francesc Jara, Angel Cequier Bellvitge University Hospital, IDIBELL (University of Barcelona), Barcelona, Spain Background: Distal embolization is a serious complication in patients (pts) with acute myocardial infarction (MI) undergoing PCI. The Mguard stent (MGS) is a novel mesh-covered stent designed to prevent thrombus embolization. The combined use of thrombus aspiration + MGS has not been evaluated yet. This study was designed to address this question. Methods: This was a single-center, single-arm, prospective registry that included all pts treated with the MGS from July 2010 to July 2011. Criteria for MGS implantation were acute MI and evidence of high thrombus burden despite mechanical aspiration. Lesions with a side branch ≥2 mm and pts with cardiogenic shock were not included. The study endpoints were proportion of final TIMI 3 flow, normal myocardial blush, and complete ST-segment resolution. Results: 50 MGS were implanted in 44 pts (age 60 ± 12 years). Thrombus aspiration was performed in 41 pts (93.2%). Atherothrombotic material was obtained in 35 (85%), being 24 (69%) thrombus with platelets/erythrocytes and 11 (31%) thrombus with plaque. Aspirated material length was 5.1 ± 0.5 mm. Study end-
Fig. 1. Study endpoints.
points are shown in Fig. 1. Side branch occlusion (b2 mm) occurred in 2 cases (4.5%), distal embolization in 3 (6.8%), and transient no-reflow in 3 cases (6.8%). During the follow-up (228 ± 21 days) no deaths occurred. 1 patient experienced an acute definite stent thrombosis. No further TLR occurred. Conclusion: The MGS implantation seems safe and highly effective in pts with acute MI and high thrombus burden despite mechanical aspiration. A randomized trial is warranted.
doi:10.1016/j.carrev.2012.01.041
Use of Viabahn stent for the treatment of in-stent restenosis in the superficial femoral artery Farzan Gorgani, Niju Baby Narakathu, Anatoliy Telis, Anvar Babaev NYU Langone Medical Center, New York, NY, USA Introduction: In-stent restenosis is a common occurrence in the superficial femoral artery (SFA). There is no universally accepted method to treat in-stent restenosis in the SFA. It is hypothesized that using the Viabahn ePTFE covered stent to treat in-stent restenosis may prevent tissue infiltration and intimal hyperplasia that lead to restenosis. Methods: We studied 22 patients (27 limbs) referred for treatment of severe SFA in-stent (non-Viabahn) restenosis. All patients were treated with Viabahn stent implanted in the restenotic segments. We also analyzed several demographic characteristics, and procedural and laboratory parameters that could potentially be predictors of Viabahn restenosis: age, sex, weight, blood pressure, GFR, WBC, monocyte count, lipids, presence of diabetes and chronic kidney disease, lesion lengths, and run-off score. Results: Among patients treated 63% had severe claudication and 37% had critical limb ischemia. Mean treated lesion length was 214.8 ± 87.2 mm, mean run off score was 3.9 ± 2.8. Mean follow up period was 18 ± 10 months. Ten patients (37%) developed Viabahn restenosis. The mean lesion length in the group with restenosis was 180.00 ± 107.88 mm and 219.4 ± 78.9 mm with no restenosis (P = .27). There was no significant difference between the two groups in the rest of demographic, procedural, and laboratory parameters. Restenosis occurred within the first 18 months with a peak at 12 months. The mean time to restenosis was 6.2 ± 4.3 months. Conclusion: Viabahn stent can be used to treat in-stent restenosis in the SFA with favorable results of 63% primary patency rates at up to 3 years of follow up. Analysis of multiple demographic factors, lesion characteristics, co-morbidities, and inflammatory markers showed no association with
Abstracts / Cardiovascular Revascularization Medicine 13 (2012) e3–e19
Marco L. Rossi, Guido Belli, Patrizia Presbitero Istituto Clinico Humanitas IRCCS, Rozzano (Milan), Italy Background: The predictive value of admission C-reactive protein (CRP) for long-term outcomes in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) is controversial. Methods: Consecutive patients with STEMI undergoing primary PCI in a single tertiary cardiac center were enrolled. High-sensitivity CRP was measured by immunonephelometric method before coronary angiography on admission. Cox regression analysis was performed to calculate hazard ratios (HR) of events with 95% confidence intervals (CI). Results: A total of 449 patients, 65.4 (55.9 ± 73.8) yrs old, 322 (71.7%) males, were enrolled. Baseline CRP levels were significantly higher in patients who died (N = 57) compared to those who remained alive [0.8 mg/dl (25th–75th percentile, 0.3–5.9 mg/dl) vs. 0.4 mg/dl (25th–75th percentile, 0.2–0.9 mg/dl), P b.001], and in patients experiencing the composite of death, non fatal myocardial infarction, target lesion or vessel revascularization, and hospitalization for heart failure (i.e. MACEs) (N = 140) compared to those without MACEs [0.52 mg/dl (25th–75th percentile, 0.27–2.72 mg/dl) vs. 0.39 mg/dl (25th–75th percentile, 0.2–0.8 mg/dl), P = .0001]. At multiple Cox regression analysis at a median follow-up of 1048 days (25th–75th percentile, 839–1334 days), CRP levels, as continuous variable, and top quartile CRP levels (i.e. CRP ≥1 mg/dl) were significant predictors of mortality [HR 1.09, 95% CI (1.05–1.13), b0.001; and HR 2.85, 95% CI (1.59–5.13), P b.001, respectively], and of MACEs [HR 1.06, 95% CI (1.03–1.09), P b.001), and HR 1.96, 95% CI (1.36–2.83), P b.001, respectively]. Conclusions: High levels of baseline systemic CRP are an independent predictor of mortality and of MACEs at long-term follow-up in patients undergoing primary PCI.
doi:10.1016/j.carrev.2012.01.040
Thrombus aspiration plus Mguard mesh covered stent for treatment of ST-segment elevation myocardial infarction Rafael Romaguera, Joan Antoni Gomez-Hospital, Guillermo Sanchez-Elvira, Josep Gomez-Lara, Gerard Roura, Jose Luis Ferreiro, Silvia Homs, Luis Teruel, Francesc Jara, Angel Cequier Bellvitge University Hospital, IDIBELL (University of Barcelona), Barcelona, Spain Background: Distal embolization is a serious complication in patients (pts) with acute myocardial infarction (MI) undergoing PCI. The Mguard stent (MGS) is a novel mesh-covered stent designed to prevent thrombus embolization. The combined use of thrombus aspiration + MGS has not been evaluated yet. This study was designed to address this question. Methods: This was a single-center, single-arm, prospective registry that included all pts treated with the MGS from July 2010 to July 2011. Criteria for MGS implantation were acute MI and evidence of high thrombus burden despite mechanical aspiration. Lesions with a side branch ≥2 mm and pts with cardiogenic shock were not included. The study endpoints were proportion of final TIMI 3 flow, normal myocardial blush, and complete ST-segment resolution. Results: 50 MGS were implanted in 44 pts (age 60 ± 12 years). Thrombus aspiration was performed in 41 pts (93.2%). Atherothrombotic material was obtained in 35 (85%), being 24 (69%) thrombus with platelets/erythrocytes and 11 (31%) thrombus with plaque. Aspirated material length was 5.1 ± 0.5 mm. Study end-
Fig. 1. Study endpoints.
points are shown in Fig. 1. Side branch occlusion (b2 mm) occurred in 2 cases (4.5%), distal embolization in 3 (6.8%), and transient no-reflow in 3 cases (6.8%). During the follow-up (228 ± 21 days) no deaths occurred. 1 patient experienced an acute definite stent thrombosis. No further TLR occurred. Conclusion: The MGS implantation seems safe and highly effective in pts with acute MI and high thrombus burden despite mechanical aspiration. A randomized trial is warranted.
doi:10.1016/j.carrev.2012.01.041
Use of Viabahn stent for the treatment of in-stent restenosis in the superficial femoral artery Farzan Gorgani, Niju Baby Narakathu, Anatoliy Telis, Anvar Babaev NYU Langone Medical Center, New York, NY, USA Introduction: In-stent restenosis is a common occurrence in the superficial femoral artery (SFA). There is no universally accepted method to treat in-stent restenosis in the SFA. It is hypothesized that using the Viabahn ePTFE covered stent to treat in-stent restenosis may prevent tissue infiltration and intimal hyperplasia that lead to restenosis. Methods: We studied 22 patients (27 limbs) referred for treatment of severe SFA in-stent (non-Viabahn) restenosis. All patients were treated with Viabahn stent implanted in the restenotic segments. We also analyzed several demographic characteristics, and procedural and laboratory parameters that could potentially be predictors of Viabahn restenosis: age, sex, weight, blood pressure, GFR, WBC, monocyte count, lipids, presence of diabetes and chronic kidney disease, lesion lengths, and run-off score. Results: Among patients treated 63% had severe claudication and 37% had critical limb ischemia. Mean treated lesion length was 214.8 ± 87.2 mm, mean run off score was 3.9 ± 2.8. Mean follow up period was 18 ± 10 months. Ten patients (37%) developed Viabahn restenosis. The mean lesion length in the group with restenosis was 180.00 ± 107.88 mm and 219.4 ± 78.9 mm with no restenosis (P = .27). There was no significant difference between the two groups in the rest of demographic, procedural, and laboratory parameters. Restenosis occurred within the first 18 months with a peak at 12 months. The mean time to restenosis was 6.2 ± 4.3 months. Conclusion: Viabahn stent can be used to treat in-stent restenosis in the SFA with favorable results of 63% primary patency rates at up to 3 years of follow up. Analysis of multiple demographic factors, lesion characteristics, co-morbidities, and inflammatory markers showed no association with