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Long-term outcome of drug-eluting stents in saphenous vein graft lesions
Abstracts / Cardiovascular Revascularization Medicine 9 (2008) 192–216 Long-term outcome of drug-eluting stents in saphenous vein graft lesions Y Kanei, J Sharma, R Diwan, NC Nakra, G Lakhanpal, JT Fox Beth Israel Medical Center, New York, NY, USA Background: The long-term safety and efficacy of using drug-eluting stents to treat saphenous vein graft (SVG) lesions remain unclear. A recent randomized study has demonstrated increased long-term mortality with using sirolimus-eluting stents in SVGs. The purpose of this study was to evaluate the long-term outcome of using drug-eluting stents (DES) in SVG lesions compared to bare metal stents (BMS). Methods: We reviewed patients who had SVG lesions treated with stents at our institution and obtained clinical follow-up via chart review and telephone interviews. Major adverse cardiac events (MACE) were defined as death, acute myocardial infarction, and target vessel revascularization. Results: We compared 42 patients (47 lesions) with DES and 46 patients (50 lesions) with BMS. Patient characteristics were similar in both groups. The mean follow-up periods were 27±10 months for DES and 44± 21 months for BMS. At 1 year, MACE was seen in 7 patients (17%) in the DES group, and 13 patients (28%) in the BMS group (P =.195). At 2 years, cumulative MACE occurred in 11 patients (26%) (four deaths) in the DES group and 16 patients (35%) (three deaths) in the BMS group (P =.383). We did not find any statistically significant predictors for longterm MACE. Conclusion: In our cohort, DES and BMS had similar outcomes at 2-year follow-up. This study does not support the contention that DES in SVG is associated with increased death. However, longer follow-up is required in a larger patient group to assess long-term effects and safety.
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Objective: To assess the feasibility and coronary artery effects of a 117mSnelectroplated stent in a clinically relevant animal model. Methods: Seventy-two stents of three types were implanted in pig coronaries: bare metal stents (BMS, n=14), Tin-only sham electroplated stents (Tin-only, n=15), and three incremental doses of radioactive 117mSn electroplated stents (low 30 μCi, n=14; medium 60 μCi, n=14; and high 150 μCi, n=15). Pigs were terminated at 1 month for complete histological analysis. Results: Intimal thickness varied according to stent type with highest level for the low, medium, and high radioactive stents compared to BMS and Tin-only (0.43±0.06, 0.41±0.06, and 0.47±0.07 mm vs. 0.17±0.02 and 0.26±0.03 mm, respectively, Pb.001). Percent area stenosis was higher for radioactive stents than for BMS and Tin-only (51±6%, 51±4%, and 55± 5% vs. 27±2% and 35±3%, respectively, Pb.001). There was consistently a distinct, discrete, dense collagenous ring of tissue which included a densely cellular outer rim, in the perivascular space at the outer adventitial border ∼0.2–0.3 mm radially outward from 117mSn stents. This appears to reflect a unique biological effect or ‘signature’ of this radioisotope in this application. Conclusions: This study showed that novel radioactive 117mSn stents were compatible with porcine coronary artery implant. Although these devices exacerbated rather than inhibited in-stent neointima formation, unique histological effects were observed that support further investigation of 117m Sn effects in the circulatory system to understand the interaction of this unique conversion electron energy with the vascular tissue. doi:10.1016/j.carrev.2008.03.078
Percutaneous left ventricular assist device for high-risk percutaneous coronary interventions: a viable option for patients who are deemed too high risk for surgical revascularization R Bashir, R Gumina, S Park, D Holmes, CS Rihal Mayo Clinic, Rochester, MN, USA
doi:10.1016/j.carrev.2008.03.077
Initial assessment of a novel radioactive Tin-117m stent in porcine coronary arteries R Jabara a, J Li a, S Srivastava b, L Pendyalaa, D Hou a, T Shinke a, N Chronos a, K Robinson a a SJRI/Saint Joseph's Hospital, Atlanta, GA, USA b Brookhaven National Laboratory, Upton, NY, USA Background: Tin-117m (117mSn) is a novel conversion electron emitting radioisotope that deposits intense energy in a very short range. It can deliver high doses of radiotherapy to a target while minimizing collateral damage to adjacent normal tissue and has been used clinically in the management of bone pain associated with osteosarcoma. There are several potential cardiovascular applications of 117mSn, one being an electroplating on stents; since the coronary media is 0.2–0.3 mm thick, no adjacent tissue exposure would result.
Background: Hemodynamic support during high-risk percutaneous coronary intervention (PCI) may be a viable strategy in patients with poor left ventricular function and left main or the equivalent disease, who are deemed too high risk for surgery. We report our experience using the TandemHeart percutaneous left ventricular assist device (pLVAD) during high-risk PCI. Methods: In-hospital and 30-day morbidity and mortality parameters were analyzed in the 42 consecutive patients undergoing high-risk PCI with circulatory support using the pLVAD. All were evaluated and deemed ineligible for surgery due to multiple co-morbidities and a very high operative risk. Given the combination of PCI complexity and poor ventricular function, the pLVAD was selected for hemodynamic support. We also compared our outcomes of the first 21 patients with our last 21 patients to assess the learning curve. Results: The baseline clinical characteristics were as follows: age 70.8± 1.7 years, males 73%, median ejection fraction of 20% , creatinine 1.7± 0.2 g/dl, recent myocardial infarction 61.3%, chronic obstructive pulmonary disease 34%, prior coronary artery bypass surgery 46.3%, diabetes mellitus 41.5%, and hypertension 82.9%. The predicted mortality by STS calculation was 14% vs. 34.8% by Euro risk score. Left main stenting was performed in 68.3% of the cases. In-hospital and 30-day morbidity was 19.0% primarily due to vascular complications ranging from bleeding, pseudoaneurysms, to an ischemic lower extremity. Five patients (12.8%) died in-hospital or within 30 days. Survival was 87.2% in-hospital, 87.2% at 30 days, and 80.6% at 6 months. The in-hospital and 6-month mortality was significantly better in the last 21 patients compared with the first 21 patients (14.2% vs. 9.5%; 28.5 vs. 13.3, P≤0.05) despite the fact that the latter group had higher STS and Euro risk scores. Conclusion: In patients with severe coronary artery disease in whom cardiac surgical alternatives are limited, percutaneous coronary revascularization with hemodynamic support provided by the percutaneous left ventricular assist device (TandemHeart) is a viable alternative. Our experience also
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Objective: To assess the feasibility and coronary artery effects of a 117mSnelectroplated stent in a clinically relevant animal model. Methods: Seventy-two stents of three types were implanted in pig coronaries: bare metal stents (BMS, n=14), Tin-only sham electroplated stents (Tin-only, n=15), and three incremental doses of radioactive 117mSn electroplated stents (low 30 μCi, n=14; medium 60 μCi, n=14; and high 150 μCi, n=15). Pigs were terminated at 1 month for complete histological analysis. Results: Intimal thickness varied according to stent type with highest level for the low, medium, and high radioactive stents compared to BMS and Tin-only (0.43±0.06, 0.41±0.06, and 0.47±0.07 mm vs. 0.17±0.02 and 0.26±0.03 mm, respectively, Pb.001). Percent area stenosis was higher for radioactive stents than for BMS and Tin-only (51±6%, 51±4%, and 55± 5% vs. 27±2% and 35±3%, respectively, Pb.001). There was consistently a distinct, discrete, dense collagenous ring of tissue which included a densely cellular outer rim, in the perivascular space at the outer adventitial border ∼0.2–0.3 mm radially outward from 117mSn stents. This appears to reflect a unique biological effect or ‘signature’ of this radioisotope in this application. Conclusions: This study showed that novel radioactive 117mSn stents were compatible with porcine coronary artery implant. Although these devices exacerbated rather than inhibited in-stent neointima formation, unique histological effects were observed that support further investigation of 117m Sn effects in the circulatory system to understand the interaction of this unique conversion electron energy with the vascular tissue. doi:10.1016/j.carrev.2008.03.078
Percutaneous left ventricular assist device for high-risk percutaneous coronary interventions: a viable option for patients who are deemed too high risk for surgical revascularization R Bashir, R Gumina, S Park, D Holmes, CS Rihal Mayo Clinic, Rochester, MN, USA
doi:10.1016/j.carrev.2008.03.077
Initial assessment of a novel radioactive Tin-117m stent in porcine coronary arteries R Jabara a, J Li a, S Srivastava b, L Pendyalaa, D Hou a, T Shinke a, N Chronos a, K Robinson a a SJRI/Saint Joseph's Hospital, Atlanta, GA, USA b Brookhaven National Laboratory, Upton, NY, USA Background: Tin-117m (117mSn) is a novel conversion electron emitting radioisotope that deposits intense energy in a very short range. It can deliver high doses of radiotherapy to a target while minimizing collateral damage to adjacent normal tissue and has been used clinically in the management of bone pain associated with osteosarcoma. There are several potential cardiovascular applications of 117mSn, one being an electroplating on stents; since the coronary media is 0.2–0.3 mm thick, no adjacent tissue exposure would result.
Background: Hemodynamic support during high-risk percutaneous coronary intervention (PCI) may be a viable strategy in patients with poor left ventricular function and left main or the equivalent disease, who are deemed too high risk for surgery. We report our experience using the TandemHeart percutaneous left ventricular assist device (pLVAD) during high-risk PCI. Methods: In-hospital and 30-day morbidity and mortality parameters were analyzed in the 42 consecutive patients undergoing high-risk PCI with circulatory support using the pLVAD. All were evaluated and deemed ineligible for surgery due to multiple co-morbidities and a very high operative risk. Given the combination of PCI complexity and poor ventricular function, the pLVAD was selected for hemodynamic support. We also compared our outcomes of the first 21 patients with our last 21 patients to assess the learning curve. Results: The baseline clinical characteristics were as follows: age 70.8± 1.7 years, males 73%, median ejection fraction of 20% , creatinine 1.7± 0.2 g/dl, recent myocardial infarction 61.3%, chronic obstructive pulmonary disease 34%, prior coronary artery bypass surgery 46.3%, diabetes mellitus 41.5%, and hypertension 82.9%. The predicted mortality by STS calculation was 14% vs. 34.8% by Euro risk score. Left main stenting was performed in 68.3% of the cases. In-hospital and 30-day morbidity was 19.0% primarily due to vascular complications ranging from bleeding, pseudoaneurysms, to an ischemic lower extremity. Five patients (12.8%) died in-hospital or within 30 days. Survival was 87.2% in-hospital, 87.2% at 30 days, and 80.6% at 6 months. The in-hospital and 6-month mortality was significantly better in the last 21 patients compared with the first 21 patients (14.2% vs. 9.5%; 28.5 vs. 13.3, P≤0.05) despite the fact that the latter group had higher STS and Euro risk scores. Conclusion: In patients with severe coronary artery disease in whom cardiac surgical alternatives are limited, percutaneous coronary revascularization with hemodynamic support provided by the percutaneous left ventricular assist device (TandemHeart) is a viable alternative. Our experience also