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Prevention of postcontrast acute kidney injury after percutaneous transluminal angioplasty by inducing RenalGuard controlled furosemide forced diuresis with matched hydration: study protocol for a randomised controlled trial.
Bolt, LJJ, Sigterman, TA, Krasznai, AG, Sikkink, CJM, Schurink, GH, Bouwman, LH
BMJ open. 2018;(9):e021842
Abstract
INTRODUCTION Percutaneous transluminal angioplasty (PTA) is often complicated due to postcontrast acute kidney injury (PC-AKI) in patients diagnosed with chronic kidney disease (CKD). Hydration therapy is the cornerstone in the prevention of PC-AKI. Furosemide forced diuresis with matched hydration using the RenalGuard system enables a steady balance between diuresis and hydration. A randomised controlled trial will be performed in order to investigate whether furosemide forced diuresis with matched hydration in combination with the RenalGuard system decreases incidence of PC-AKI in patients with CKD receiving a PTA of the lower extremities. Furthermore, we will investigate whether sampling of urine biomarkers 4 hours after intervention can detect PC-AKI in an earlier stage compared with the golden standard, serum creatinine 48-72 hours postintervention. METHODS AND ANALYSIS A single-centre randomised controlled trial will be conducted. Patients >18 years in need of a PTA of the lower extremities and diagnosed with CKD will be randomly assigned to receive either standard of care prehydration and posthydration or furosemide forced diuresis with matched hydration periprocedural using the RenalGuard system. Four hours postintervention, a urine sample will be collected of all participating patients. Serum creatinine will be sampled within 10 days prior to intervention as well as 1, 3 and 30 days postintervention. The primary endpoint is incidence of PC-AKI post-PTA. Secondary endpoint is the rise of urine biomarkers 4 hours postintervention. ETHICS AND DISSEMINATION Study protocol is approved by the research ethics committee and institutional review board (reference number 16 T-201 and NL59809.096.16). Study results will be disseminated by oral presentation at conferences and will be submitted to a peer-reviewed journal. It is anticipated that study results will offer a solution to contrast-induced nephropathy in patients with CKD receiving a PTA of the lower extremities. TRIAL REGISTRATION NUMBER NTR6236; Pre-results. EUDRACT NUMBER 2016-005072-10.
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A new category stent with novel polyphosphazene surface modification.
Mori, H, Jinnouchi, H, Diljon, C, Torii, S, Sakamoto, A, Kolodgie, FD, Virmani, R, Finn, AV
Future cardiology. 2018;(3):225-235
Abstract
The COBRA-PzF™ (CeloNova BioSciences, Inc., TX, USA) is a new type of coronary stent composed of a cobalt chromium metallic backbone surrounded by a nanothin layer of Polyzene-F (PzF) without any added drug. Evidence from basic studies supports antithrombotic and anti-inflammatory properties for the PzF surface coating. Preclinical studies support the thromboresistance of PzF-coated surfaces and clinical studies have shown good outcomes for patients receiving this device with very low rates of stent thrombosis. COBRA-PzF may be especially useful in patients at high risk for bleeding. Ongoing clinical trials will determine whether shortening the duration of dual antiplatelet therapy to less than 1 month is feasible and these data may represent a new paradigm with regards to patients at high risk for bleeding.
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Manipal lifestyle modification score to predict major adverse cardiac events in postcoronary angioplasty patients.
Devasia, T, Shetty, PN, Kareem, H, Karkala, YR, Singh, A
Indian heart journal. 2018;(Suppl 3):S353-S358
Abstract
BACKGROUND Lifestyle modification (LSM) such as prudent diet, physical activity, avoidance of smoking, and maintaining a healthy weight may considerably decrease the risk for coronary artery disease. OBJECTIVE The primary objective of this study was to develop a new LSM scoring system and investigate the correlation between adherence to LSM and incidence of major adverse cardiac events (MACEs) at 12-month follow-up. METHOD A total of 1000 consecutive patients who underwent percutaneous transluminal coronary angioplasty (PTCA) were included in this prospective single-center study. Manipal lifestyle modification score (MLSMS) was developed by using five lifestyle-related factors. Adherence to LSM at the baseline and subsequent follow-ups was determined by using MLSMS. The MACE at 1-, 6-, and 12-month follow-up were analyzed. RESULTS There was a significant reduction in overall adherence to LSM (p < 0.001) at 12-month follow-up. Nonadherence to LSM [hazard ratio (HR) 0.575; 95% confidence interval (CI) 0.334-0.990; p < 0.046] and noncompliance to medication (HR 2.09; 95% CI 1.425-3.072; p < 0.001) were independent predictors of MACEs after PTCA. The cumulative MACE was 15.4%, which includes 4.9% of all-cause death, 5.2% of nonfatal myocardial infarction, 2.0% of target lesion revascularization, 1.8% of target vessel revascularization, and 1.3% of stroke at 12 months. The incidence of MACEs at 12 months was significantly (p = 0.03) higher in LSM nonadherent compared with LSM adherent patients. CONCLUSION There is an overall reduction in adherence to LSM on successive follow-ups and a significant association between the incidence of MACEs and the lack of adherence to LSM. MLSMS is a simple and effective evaluation tool in predicting MACEs in this group of patients.
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Low-Level Tragus Stimulation for the Treatment of Ischemia and Reperfusion Injury in Patients With ST-Segment Elevation Myocardial Infarction: A Proof-of-Concept Study.
Yu, L, Huang, B, Po, SS, Tan, T, Wang, M, Zhou, L, Meng, G, Yuan, S, Zhou, X, Li, X, et al
JACC. Cardiovascular interventions. 2017;(15):1511-1520
Abstract
OBJECTIVES The aim of this study was to investigate whether low-level tragus stimulation (LL-TS) treatment could reduce myocardial ischemia-reperfusion injury in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND The authors' previous studies suggested that LL-TS could reduce the size of myocardial injury induced by ischemia. METHODS Patients who presented with STEMI within 12 h of symptom onset, treated with primary percutaneous coronary intervention, were randomized to the LL-TS group (n = 47) or the control group (with sham stimulation [n = 48]). LL-TS, 50% lower than the electric current that slowed the sinus rate, was delivered to the right tragus once the patients arrived in the catheterization room and lasted for 2 h after balloon dilatation (reperfusion). All patients were followed for 7 days. The occurrence of reperfusion-related arrhythmia, blood levels of creatine kinase-MB, myoglobin, N-terminal pro-B-type natriuretic peptide and inflammatory markers, and echocardiographic characteristics were evaluated. RESULTS The incidence of reperfusion-related ventricular arrhythmia during the first 24 h was significantly attenuated by LL-TS. In addition, the area under the curve for creatine kinase-MB and myoglobin over 72 h was smaller in the LL-TS group than the control group. Furthermore, blood levels of inflammatory markers were decreased by LL-TS. Cardiac function, as demonstrated by the level of N-terminal pro-B-type natriuretic peptide, the left ventricular ejection fraction, and the wall motion index, was markedly improved by LL-TS. CONCLUSIONS LL-TS reduces myocardial ischemia-reperfusion injury in patients with STEMI. This proof-of-concept study raises the possibility that this noninvasive strategy may be used to treat patients with STEMI undergoing primary percutaneous coronary intervention.
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Treatment of drug-eluting stents in-stent restenosis with paclitaxel-coated balloon angioplasty: Insights from the French "real-world" prospective GARO Registry.
Auffret, V, Berland, J, Barragan, P, Waliszewski, M, Bonello, L, Delarche, N, Furber, A, Albert, F, Carrié, D, Eltchaninoff, H, et al
International journal of cardiology. 2016;:690-6
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Abstract
BACKGROUND Data about paclitaxel-eluting balloon (PCB) angioplasty to treat drug-eluting stents (DES) in-stent restenosis (ISR) were mainly collected in selected patient populations in the setting of randomized trials. The main goal of this prospective registry was to confirm the positive findings of these studies in an unselected population in clinical practice. METHODS Consecutive patients with DES-ISR treated by PCB angioplasty were recruited in this prospective real-world registry. The primary endpoint was clinically driven target-lesion revascularization (TLR) at 9 months. Secondary endpoints included acute technical success, in-hospital outcomes, 9-month major adverse cardiac events (MACE) a composite of death, myocardial infarction (MI) and TLR and the occurrence of target vessel revascularization. RESULTS A total of 206 patients (67.7 ± 10.2 years, 80.6% male, 41.3% diabetics) with 210 lesions were recruited. Unstable coronary artery disease was present in 55.3% of patients. The time from DES implantation to DES-ISR was 3.0 ± 2.4 years. Quantitative analyses revealed that patterns of treated DES-ISR were focal in 55.7% and diffuse in 44.3%. The reference diameter was 2.76 ± 0.64 mm. The 9-month follow-up rate was 90.8% (187/206). At 9 months, the TLR rate was 7.0% (13/187) whereas the rates for MACE, MI and cardiac death were 10.7% (20/187), 4.8% (9/187) and 2.1% (4/187) respectively. Results were consistent in patients with paclitaxel and non-paclitaxel-eluting stents (PES) ISR. CONCLUSION This large prospective registry demonstrated acceptable rates of TLR and MACE at 9 months after treatment of DES-ISR by PCB angioplasty. PCB angioplasty was equally effective in patients with PES-ISR and non PES-ISR.
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Anatomical and Physiological Changes after Paclitaxel-Coated Balloon for Atherosclerotic De Novo Coronary Lesions: Serial IVUS-VH and FFR Study.
Ann, SH, Balbir Singh, G, Lim, KH, Koo, BK, Shin, ES
PloS one. 2016;(1):e0147057
Abstract
AIMS: To assess the serial changes of de novo coronary lesions treated with paclitaxel-coated balloon (PCB) using intravascular ultrasound virtual histology (IVUS-VH) and fractional flow reserve (FFR). METHOD AND RESULTS This prospective observational study enrolled 27 patients with coronary artery disease treated with PCB who underwent coronary angiography, IVUS-VH and FFR before, immediately after intervention and at 9 months. 28 de novo lesions were successfully treated with PCB. Angiographic late luminal loss was 0.02 ± 0.27 mm. Mean vessel and lumen areas showed increase at 9 months (12.0 ± 3.5 mm(2) to 13.2 ± 3.9 mm(2), p <0.001; and 5.4 ± 1.2 mm(2) to 6.5 ± 1.8 mm(2), p <0.001, respectively). Although mean plaque area was unchanged (6.6 ± 2.6 mm2 to 6.6 ± 2.4 mm(2), p = 0.269), percent atheroma volume decreased significantly (53.4 ± 7.9% to 49.5 ± 6.4%, p = 0.002). The proportion of plaque compositions including fibrous, fibrofatty, dense calcium and necrotic core by IVUS-VH was unchanged at 9 months. The FFR of the treated lesion was 0.71 ± 0.13 pre-procedure, 0.87 ± 0.06 post-procedure and 0.84 ± 0.06 at follow-up. CONCLUSIONS De novo coronary lesions treated with PCB showed persistent anatomical and physiological patency with plaque redistribution and vessel remodeling without chronic elastic recoil or plaque compositional change during follow-up.
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Coronary liposuction during percutaneous coronary intervention: evidence by near-infrared spectroscopy that aspiration reduces culprit lesion lipid content prior to stent placement.
Erlinge, D, Harnek, J, Gonçalves, I, Götberg, M, Muller, JE, Madder, RD
European heart journal. Cardiovascular Imaging. 2015;(3):316-24
Abstract
AIMS: Intracoronary near-infrared spectroscopy (NIRS) in ST-segment elevation myocardial infarction (STEMI) has demonstrated substantial lipid in STEMI culprit plaques. Thrombus aspiration during primary PCI reduces distal embolization and improves reperfusion. This study was performed to examine if aspiration thrombectomy reduces the lipid content of acute coronary syndrome (ACS) culprit plaques. METHODS AND RESULTS NIRS-IVUS imaging was performed in patients with an ACS at two hospitals in the US and Sweden. After establishment of TIMI 3 flow with an undersized balloon, NIRS was performed, followed by aspiration thrombectomy, followed by repeated NIRS. The same culprit segment was identified on the post-aspiration chemogram. The culprit lipid content was quantified before and after thrombectomy as the lipid core burden index (LCBI). Aspirates were examined by histological staining for lipids, calcium, and macrophages. In 18 ACS patients (age 65 ± 11, 61% male), culprit lesions were characterized by high lipid content prior to aspiration thrombectomy. Thrombectomy resulted in a 28% reduction in culprit lesion lipid content (pre-aspiration LCBI 466 ± 141 vs. post-aspiration 335 ± 117, P = 0.0001). In addition to thrombus, histological analysis of aspirates demonstrated the presence of lipids, calcium, and macrophages, indicating that fragments of atherosclerotic plaques had been aspirated. CONCLUSION Thrombectomy aspirates both thrombus and lipid-rich fragments of the culprit atherosclerotic plaques, thereby reducing material that may embolize during stenting. Reduction of lipid content before stenting might contribute to the beneficial effects of thrombectomy and may be particularly useful if a large lipid core is present at the culprit site.
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[Cardiac Rehabilitation 2015].
Hoffmann, A
Praxis. 2015;(24):1317-22
Abstract
The goals of cardiac rehabilitation are (re-)conditioning and secondary prevention in patients with heart disease or an elevated cardiovascular risk profile. Rehabilitation is based on motivation through education, on adapted physical activity, instruction of relaxation techniques, psychological support and optimized medication. It is performed preferably in groups either in outpatient or inpatient settings. The Swiss working group on cardiac rehabilitation provides a network of institutions with regular quality auditing. Positive effects of rehabilitation programs on mortality and morbidity have been established by numerous studies. Although a majority of patients after cardiac surgery are being referred to rehabilitation, these services are notoriously underused after catheter procedures.
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Management of multivessel coronary disease after primary angioplasty: staged reintervention versus optimized clinical treatment and two-year follow-up.
Paula, JG, Godoy, MF, Santos, MA, Pivatelli, FC, Osti, AV, Trindade, LF, Novelli, D, Nakazone, MA
Revista brasileira de cirurgia cardiovascular : orgao oficial da Sociedade Brasileira de Cirurgia Cardiovascular. 2014;(2):177-85
Abstract
OBJECTIVE In the clinical scenario of ST-segment elevation acute myocardial infarction, several patients with multivessel coronary atherosclerotic disease are discharged without a defined strategy to monitor the residual atherosclerotic lesions. The clinical endpoints evaluated were cardiovascular death, symptoms of angina pectoris, rehospitalization for a new acute coronary syndrome, and the necessity of reintervention during the two-year follow-up. METHODS This observational, prospective, and historical study included multivessel coronary atherosclerotic disease patients who were admitted to a tertiary care university hospital with ST-segment elevation acute myocardial infarction and underwent primary percutaneous coronary intervention with stent implantation only at the culprit lesion site; these patients were monitored in the outpatient clinic according to two treatments: the Clinical Group - CG (optimized pharmacological therapy associated with counseling for a healthy diet and cardiac rehabilitation) or the Intervention Group - IG (new staged percutaneous coronary intervention or surgical coronary artery bypass graft surgery combined with the previously prescribed treatment). RESULTS Of 143 patients consecutively admitted with ST-segment elevation acute myocardial infarction, 57 were eligible for the study (CG=44 and IG=13). Regarding the clinical endpoints, the cardiovascular death rate did not differ between the CG and IG. The symptom of angina pectoris and the rehospitalization rate for a new episode of acute coronary syndrome were accentuated in the CG (P=0.020 and P=0.049, respectively) mainly in individuals with evidence of ischemia evidenced by myocardial scintigraphy (P<0.001 and P=0.001, respectively) which culminated in an even greater need for reintervention (P=0.001) in this subgroup of patients. CONCLUSION The staged intervention was demonstrated to be safe and able to reduce angina pectoris and rehospitalization for a new episode of acute coronary syndrome. In addition, it decreases the likelihood of unplanned reinterventions of patients without ischemia evidenced by myocardial scintigraphy.
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[Interventional treatment in acute coronary syndrome].
Rupprecht, HJ, Voigtländer, T, Dietz, U, Haude, M, Bickel, C
Deutsche medizinische Wochenschrift (1946). 2014;:S23-6