Device safety assessment of bronchoscopic microwave ablation of normal swine peripheral lung using robotic-assisted bronchoscopy.

INTRODUCTION: The aim of this study was to assess the safety of bronchoscopic microwave ablation (MWA) of peripheral lung parenchyma using the NEUWAVE™ FLEX Microwave Ablation System, and robotic-assisted bronchoscopy (RAB) using the MONARCH™ Platform in a swine model. METHODS: Computed tomography (CT)-guided RAB MWA was performed in the peripheral lung parenchyma of 17 Yorkshire swine (40-50 kg) and procedural adverse events (AEs) documented. The acute group (day 0, n = 5) received 4 MWAs at 100 W for 1, 3, 5, and 10 min in 4 different lung lobes. Subacute and chronic groups (days 3 and 30, n = 6 each) received one MWA (100 W, 10 min) per animal. RESULTS: The study was completed without major procedural complications. No postprocedural AEs including death, pneumothorax, bronchopleural fistula, hemothorax, or pleural effusions were observed. No gross or histological findings suggestive of thromboembolism were found in any organ. One 3-Day and one 30-Day swine exhibited coughing that required no medication (minor AEs), and one 30-Day animal required antibiotic medication (major AE) for a suspected lower respiratory tract infection that subsided after two weeks. CT-based volumetric estimates of ablation zones in the acute group increased in an ablation time-dependent (1-10 min) manner, whereas macroscopy-based estimates showed an increasing trend in ablation zone size. CONCLUSION: The NEUWAVE FLEX and MONARCH devices were safely used to perform single or multiple RAB MWAs. The preclinical procedural safety profile of RAB MWA supports clinical research of both devices to investigate efficacy in select patients with oligometastatic disease or primary NSCLC.

Long-term performance and biocompatibility of a novel bioresorbable scaffold for peripheral arteries: A three-year pilot study in Yucatan miniswine.

AIMS: Peripheral arteries are constantly exposed to deformation (elongation, twisting, shortening, compression) making bioresorbable scaffolds (BRS) a potentially attractive therapeutic alternative to metallic stents. We conducted a long-term pilot preclinical study of a novel sirolimus-eluting BRS in peripheral arteries. METHODS AND RESULTS: Fourteen BRS were deployed in iliofemoral arteries of seven healthy Yucatan miniswine and examined with imaging, pharmacokinetic, histopathologic, and polymer degradation techniques at 0, 30, 90, 180 days, 1, 2, and 3.3 years. Angiographic late luminal loss remained unchanged at 30 and 180 days but significantly decreased from 1 to 3.3 years. optical coherence tomography (OCT) showed late increase in lumen area (1 year: 14.70 ± 3.58 mm2 , 2 years 22.04 ± 3.81 mm2 , and 3.3 years 23.45 ± 7.07 mm2 ; p < .05) primarily due to scaffold area enlargement between 1 and 3.3 years, while there was no difference in the percent area stenosis at all time points. Histologic evidence of scaffold degradation was observed starting at 2 years, with minimal inflammatory reaction. At 3.3 years, BRS struts were rarely discernible by OCT, confirmed by a nearly complete polymer degradation by molecular weight analysis. CONCLUSIONS: In this pilot study, novel sirolimus-eluting BRS showed promising acute and chronic performance in the iliofemoral arteries of Yucatan miniswine.

Novel ultrahigh molecular weight amorphous PLLA bioresorbable coronary scaffold upsized up to 0.8 mm beyond nominal diameter: An OCT and histopathology study in porcine coronary artery model.

OBJECTIVES: The aim of the study was to evaluate the biomechanical properties and healing pattern of novel sirolimus-eluting, ultrahigh molecular weight amorphous poly-L-lactic acid bioresorbable scaffolds (S-BRS) that have been postdilated by 0.55 and 0.8 mm beyond the nominal diameters within the pressure-diameter compliance chart range. BACKGROUND: Due to the inherent limitations of bioabsorbable polymeric materials, overexpansion/upsizing may be very limited for some BRS such as the benchmark Absorb BVS. The unique biomechanical properties of the novel S-BRS may allow it to be safely upsized. METHODS AND RESULTS: 12 coronary arteries of 4 healthy Yucatan mini-swine underwent implantation of a novel S-BRS. Upsizing by postdilation was performed up to 0.55mm (PLUS 0.55, n = 6) or 0.8 mm (PLUS 0.8, n = 6) in a manner maintaining consistent 1:1.1 stent-to-artery, thus ensuring not only the overexpansion of the scaffold but consistent level of arterial injury. Optical coherence tomography (OCT) follow-up was performed at 28 and 90-days follow-up. There was no statistical difference between the tested groups in terms of acute recoil. OCT analysis after 28 days showed numerically lower levels of neointimal formation in PLUS 0.8 compared to PLUS 0.55 group. These results were sustained at 90-days follow-up. There was no difference in late recoil between studied groups. No scaffold discontinuation, deformation or overlapping of the struts were observed. CONCLUSIONS: Overexpansion up to 0.8 mm of novel, high strength S-BRS is not associated with worse angiographic outcomes, neointimal formation or biomechanical issues such as scaffold discontinuation, deformation or overlapping of the struts, neither acutely nor chronically. © 2017 Wiley Periodicals, Inc.

An optical coherence tomography study of neointimal morphology and strut coverage at different time intervals from implantation of biodegradable polymer-coated sirolimus-eluting stents.

OBJECTIVES: The aim of the study was to capture the evolution of neointima after implantation of a biodegradable polymer-coated, sirolimus-eluting, cobalt-chromium coronary stent system (BP-DES). BACKGROUND: Optical coherence tomography (OCT) suggests that in-stent neointimal morphology influences clinical outcomes after DES implantation. METHODS: Sixty patients treated with single BP-DES implantation were examined by quantitative coronary angiography (QCA) and OCT at 3, 6, and 12-month follow-up. RESULTS: Median late lumen loss by QCA (mm) was 0.04 (IQR 0, 0.08), 0.17 (IQR 0, 0.32), and 0.14 (IQR 0.07, 0.31) at 3, 6, and 12-month follow-up respectively (P = 0.03). OCT cross-section multilevel analysis showed uncovered struts in 3.90%, 1.78%, and 0.02% of struts respectively (P = 0.03). The corresponding malapposition rates were 0.12%, 0.04%, and 0%. Lipid-rich neointima was observed only at 12-month follow-up in one restenotic lesion (0.77% cross-sections) that was accountable for the only target vessel revascularization. The homogeneous pattern was prevalent at all three time points, but its incidence displayed an upward trend (3 months: 59%; 6 months: 71%; 12 months: 88%) despite no difference in neointimal volume between 6 and 12 months. Conversely, a trend could be observed of decreasing incidence of heterogeneous pattern as the follow-up length increased. CONCLUSIONS: In this study of a single-type BP-DES, the majority of stent struts were covered within 3 months from implantation. While the quantitative neointimal accumulation plateaued at 6 months with no further significant increase beyond 6 months, the neointima continued to evolve qualitatively and mature along with better strut coverage between 6 and 12 months after implantation.

A 12-month angiographic and optical coherence tomography follow-up after bioresorbable vascular scaffold implantation in patients with ST-segment elevation myocardial infarction.

OBJECTIVES: The aim of the study was to evaluate the healing process at 12 months after ABSORB™ bioresorbable vascular scaffold (BVS) implantation in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND: There is currently no data on long-term BVS performance in the acute thrombotic setting. The underlying altered plaque pathomorphology may impact the neointima healing pattern, potentially making it different to that observed in stable coronary artery disease (CAD). METHODS: We have performed an angiographic and optical coherence tomography (OCT) 12-month follow-up of 19 STEMI patients who were treated with a BVS implantation (23 scaffolds). An independent core laboratory performed a paired analysis of the corresponding frames at baseline and follow-up. RESULTS: At 12 months, the OCT follow-up showed a decrease in the mean lumen area (8.29 ± 1.53 mm(2) vs. 6.82 ± 1.57 mm(2) , P < 0.001), but no significant change in the mean scaffold area (8.49 ± 1.53 mm(2) vs. 8.90 ± 1.51 mm(2) ). Significant decreases in malapposed strut ratio (4.9 ± 8.65% vs. 0.4 ± 1.55%, P < 0.001) and malapposition area (0.29 ± 0.60 mm(2) 0.08 ± 0.32 mm(2) , P = 0.002) were observed. A nonhomogenous proliferation of neointima was revealed with a symmetry index of 0.15 (0.08-0.27), a mean neointima thickness of 203 µm (183-249) and mean neointima area of 2.07 ± 0.51 mm(2) . The quantitative coronary angiography showed late lumen loss of 0.08 ± 0.23 mm and no significant change in the minimal lumen diameter (P = 0.11). There were no major adverse cardiovascular events (MACE), except for one nontarget vessel revascularization. CONCLUSIONS: The OCT revealed a favorable healing pattern after BVS implantation in a STEMI population.

Performance, safety, and biocompatibility of a novel PFO closure device in a long-term porcine model.

BACKGROUND: As the catheter-based device closure of the patent foramen ovale (PFO) is expanding, novel devices aim to address the limitations of first-generation occluders (e.g. bulk, erosion, dislodgment). The second-generation device from Encore Medical (Eagan, MN, USA) features an articulating frame structure which allows the device to better conform to atrial anatomies, has lower disc thickness and metal mass/surface area, and is fully retrievable at any point in the procedure. The aim of the study was to evaluate the feasibility and safety of a novel low-profile, fully retrievable, Encore PFO closure device in the animal model. METHODS: Six swine underwent implantation of the novel PFO occluder under fluoroscopic and intra-cardiac echocardiography guidance and survived for 140 days. Interim transthoracic echocardiography (TTE) was conducted on Day 29. Following terminal angiography and TTE at 140 days, the hearts were subjected to gross and histopathologic analysis. RESULTS: All animals were successfully implanted and survived for 140 days. Interim TTE revealed proper device retention with no blood flow across the septum or thrombus in any of the animals. X-ray and pathology results showed preserved implant integrity with no fractures, and complete integration of the devices into the septum with complete re-endothelialization and nearly complete coverage by a mature, relatively thin neoendocardium. No surface fibrin deposition or thrombosis was reported. CONCLUSIONS: In the standard porcine model, device retention and biocompatibility remained favorable following structural and functional device modifications exemplified by the second-generation PFO occluder from Encore Medical, including marked reduction of metal mass.

A clinical evaluation of the ProNOVA XR polymer-free sirolimus eluting coronary stent system in the treatment of patients with de novo coronary artery lesions (EURONOVA XR I study).

AIMS: Evaluation of safety and efficacy of ProNOVA XR, a new generation of polymer-free sirolimus eluting stents (SES), utilizing a pharmaceutical excipient for timed release of sirolimus from the XR platform. METHODS AND RESULTS: Safety and efficacy of ProNOVA XR coronary stent system was examined in EURONOVA prospective, single arm, multi-center registry of 50 patients with de novo native coronary lesions up to 28 mm in length in arteries between 2.25 and 4 mm. At 6-month, in-stent late lumen loss by QCA was 0.45 ± 0.41 mm and in-stent neointimal volume obstruction in the IVUS sub-study was 14 ± 11%. One-year clinical follow-up revealed a favorable safety profile, with 2% of in-hospital MACE and 6.4% of MACE from hospital discharge up to 12 months (including 1 cardiac death >30 days after stent implantation and 2 TLRs). According to the ARC definition, there was no definite or probable stent thrombosis and 1 possible stent thrombosis (2%) up to 12 months of clinical follow-up. CONCLUSIONS: In this preliminary evaluation, ProNOVA XR polymer-free sirolimus eluting stent system appeared safe with an early promise of adequate effectiveness in the treatment of de novo coronary lesions in up to 12 months of clinical, angiographic and IVUS follow-up.

Longitudinal dynamics of circulating miRNAs in a swine model of familial hypercholesterolemia during early atherosclerosis.

Atherosclerosis is a complex progressive disease involving intertwined biological mechanisms. We aimed to identify miRNA expression dynamics at the early stages of atherosclerosis using a large swine model (Wisconsin Miniature Swine, WMS). A total of 18 female pigs; 9 familial hypercholesterolemic (WMS-FH) and 9 normal control swine (WMS-N) were studied. miRNA sequencing was performed on plasma cell-free RNA at 3, 6, and 9 months of age. RT-qPCR validated DE miRNAs in a new cohort of animals (n = 30) with both sexes. Gene ontology and mRNA targets for DE miRNAs were identified. In vivo multimodality imaging and histopathology were performed to document the presence of atherosclerosis at termination. 20, 19, and 9 miRNAs were significantly DE between the groups at months 3, 6, and 9, respectively. Most DE miRNAs and their target genes are involved in human atherosclerosis development. Coronary atherosclerosis was documented in 7/9 WMS-FH pigs. Control animals had no lesions. miR-138, miR-152, miR-190a, and miR-196a showed a significant diagnostic power at month 3, whereas miR-486, miR-126-3p, miR-335, and miR-423-5p were of significant diagnostic power at month 9. In conclusion, specific DE miRNAs with significant discriminatory power may be promising biomarkers for the early detection of coronary atherosclerosis.

Intracoronary Imaging of Vulnerable Plaque-From Clinical Research to Everyday Practice.

The introduction into clinical practice of intravascular imaging, including intravascular ultrasound (IVUS), optical coherence tomography (OCT) and their derivatives, allowed for the in vivo assessment of coronary atherosclerosis in humans, including insights into plaque evolution and progression process. Intravascular ultrasound, the most commonly used intravascular modality in many countries, due to its low resolution cannot assess many features of vulnerable plaque such as lipid plaque or thin-cap fibroatheroma. Thus, novel methods were introduced to facilitate this problem including virtual histology intravascular ultrasound and later on near-infrared spectroscopy and OCT. Howbeit, none of the currently used modalities can assess all known characteristics of plaque vulnerability; hence, the idea of combining different intravascular imaging methods has emerged including NIRS-IVUS or OCT-IVUS imaging. All of those described methods may allow us to identify the most vulnerable plaques, which are prone to cause acute coronary syndrome, and thus they may allow us to introduce proper treatment before plaque destabilization.

Chronic myocardial and coronary arterial effects of intracoronary supersaturated oxygen therapy in swine with normal and ischemic-reperfused myocardium.

The study assessed chronic myocardial, coronary and systemic effects of intracoronary supersaturated oxygen (SSO2) therapy. Left anterior descending coronary arteries of 40 swine were stented and randomized to 90-min selective intracoronary infusion of SSO2 (pO2 760-1000 mmHg) or normoxemic saline. In 20 out of 40 animals, SSO2 delivery followed a 60-min balloon occlusion to induce myocardial infarction (MI). In both normal and MI models, intracoronary treatment with hyperoxemic SSO2 therapy showed no evidence of coronary thrombosis. There were no biologically relevant differences between treatments at either time point in regard to coronary intervention site healing and neointimal growth. No signs of any myocardial or systemic toxicity were observed after 7 or 30 days. A trend was observed toward reduced incidence of microscopic MI scars and reduced infarct size in histopathology, as well as toward better recovery of echocardiographically evaluated global and regional contractility at 30 days. No treatment related infarcts or thromboemboli were observed in the downstream organs.

Use of fluoroscopy to study in vivo motility in mouse pups.

OBJECTIVES: Few methods exist to noninvasively study in vivo gastrointestinal motility in animal models of enteric infections. None have been used on mouse pups, which often display more severe symptoms during enteric infections than adult mice. This study sought to determine whether digital fluoroscopy could be used to evaluate gastrointestinal motility in mouse pups as well as adult mice. MATERIALS AND METHODS: Fluoroscopic imaging studies were performed on normal 6- to 8-week-old adult mice and 12-day-old pups to develop protocols for evaluating gastric and intestinal wall movements and changes in stomach sizes. These protocols were then applied to evaluate motility in an established rotavirus mouse model. Imaging studies were performed on adult mice at 0, 2, and 4 days postinfection and on 12-day-old pups at 2 days postinfection. RESULTS: Fluoroscopic studies revealed postnatal differences of gastric peristalsis and rates of intestinal contractions between normal mouse pups and adult mice. Studies of the rotavirus mouse model revealed that differences in gastric function occur between rotavirus-infected and control mouse pups, but no discernible difference occurs between infected and control adult mice. In contrast, there were no detectable differences in rates of intestinal wall movements between control pups with normal stools and infected pups with loose stools. CONCLUSIONS: These results demonstrate that fluoroscopy can evaluate in vivo motility in mouse pups and by doing so provide findings that are clinically relevant to the study of enteric infections in young.

Downstream Paclitaxel Released Following Drug-Coated Balloon Inflation and Distal Limb Wound Healing in Swine.

The authors evaluated the presence of paclitaxel and healing of distal hind limb wounds created in 27 swine using biopsy punches followed by paclitaxel-coated balloon (PCB) use in the iliofemoral arteries of healthy swine. After 14 and 28 days, no differences were seen in time course, appearance, and histopathology of wound healing between the single or triple PCB and uncoated balloon treatment despite clinically relevant paclitaxel concentrations in the skin adjacent to the healing wounds. Presence of paclitaxel downstream from the PCB treatment site does not impair the wound healing response of preexisting distal cutaneous lesions in healthy swine.

Two-year longitudinal evaluation of a second-generation thin-strut sirolimus-eluting bioresorbable coronary scaffold with hybrid cell design in porcine coronary arteries.

BACKGROUND: The first commercially available bioresorbable scaffold (BRS) had a strut thickness of 156 microns. As such, it had the potential for delivery challenges and higher thrombogenicity. The aim herein, is to evaluate biomechanical performance, pharmacokinetics and vascular healing of a novel thin strut (100 µm) sirolimus eluting BRS (MeRes-100, Meril Life Sciences, Gujarat, India) against the once clinically used BRS (Absorb BVS, Abbott, Santa Clara, CA) in porcine coronary arteries. METHODS: Following device implantation, angiographic and optical coherence tomography (OCT) evaluation were performed at 45, 90, 180 days, 1 year and 2 years. Histological evaluation was per-formed at 30, 90 and 180 days. RESULTS: At 2 years, both lumen (MeRes-100 7.07 ± 1.82 mm² vs. Absorb BVS 7.57 ± 1.39 mm2, p = NS) and scaffold areas (MeRes-100 9.73 ± 1.80 mm² vs. Absorb BVS 9.67 ± 1.25 mm², p = NS) were comparable between tested and control scaffolds. Also, the late lumen area gain at 2 years was similar in both groups tested (MeRes-100 1.03 ± 1.98 mm² vs. Absorb BVS 0.85 ± 1.56 mm², p = NS). Histologic examination up to 6 months showed comparable healing and inflammation profiles for both devices. CONCLUSIONS: The novel sirolimus-eluting BRS with thinner struts and hybrid cell design showed similar biomechanical durability and equivalent inhibition of neointimal proliferation when compared to the first-ever Absorb BVS up to 2 years in normal porcine coronary arteries.

Impact of Coronary Atherosclerosis on Bioresorbable Vascular Scaffold Resorption and Vessel Wall Integration.

The integration of the Absorb bioresorbable vascular scaffold (BVS) into the arterial wall has never been tested in an in vivo model of atherosclerosis. This study aimed to compare the long-term (up to 4 years) vascular healing responses of BVS to an everolimus-eluting metallic stent in the familial hypercholesterolemic swine model of atherosclerosis. The multimodality imaging and histology approaches indicate that the resorption and vascular integration profile of BVS is not affected by the presence of atherosclerosis. BVS demonstrated comparable long-term vascular healing and anti-restenotic efficacy to everolimus-eluting metallic stent but resulted in lower late lumen loss at 4 years.

In vitro mechanical behavior and in vivo healing response of a novel thin-strut ultrahigh molecular weight poly-l-lactic acid sirolimus-eluting bioresorbable coronary scaffold in normal swine.

BACKGROUND: New generation bioresorbable scaffolds (BRS) promise to improve the outcomes of current generation BRS technologies by decreasing wall thickness while maintaining structural strength. This study aimed to compare the biomechanical behavior and vascular healing profile of a novel thin-walled (98 µm) sirolimus-eluting ultrahigh molecular weight BRS (Magnitude, Amaranth Medical) to the Absorb everolimus-eluting bioresorbable vascular scaffold (Abbott Vascular). METHODS AND RESULTS: In vitro biomechanical testing showed lower number of fractures on accelerated cycle testing over time (at 21K cycles = 20.0 [19.0-21.0] in Absorb versus 0.0 [0.0-1.0] in Magnitude-BRS). Either Magnitude (n = 43) or Absorb (n = 22) was implanted in 65 coronary segments of 22 swine. Scaffold strut's coverage was evaluated using serial optical coherence tomography (OCT) analysis. At 14 days, Magnitude-BRS demonstrated a higher percentage of embedded struts (97.7% [95.3, 100.0] compared to Absorb (57.2% [48.0, 76.0], p = 0.003) and lower percentage of uncovered struts (0.0% [0.0, 0.0] versus Absorb 5.5% [2.6, 7.7], p = 0.02). Also, it showed a lower percent late recoil (-1.02% [-4.11, 3.21] versus 4.42% [-1.10, 8.74], p = 0.04) at 28 days. Histopathology revealed comparable neointimal proliferation and vascular healing responses between two devices up to 180 days. CONCLUSION: A new generation thin walled (98-µm) Magnitude-BRS displayed a promising biomechanical behavior and strut healing profile compared to Absorb at the experimental level. This new generation BRS platform has the potential to improve the clinical outcomes shown by the current generation BRS.

In vivo comparison of key quantitative parameters measured with 3D peripheral angiography, 2D peripheral quantitative angiography and intravascular ultrasound.

The aim of this study was to compare the measures of luminal stenosis between the two-dimensional (2D) and three-dimensional (3D) Quantitative Vessel Analysis (QVA) generated by CAAS QVA software and intravascular ultrasound (IVUS). Invasive contrast angiography is considered gold standard for diagnostic imaging and intervention in both coronary and peripheral arterial disease. However, it is based on 2D images depicting complicated 3D arterial anatomy. To overcome these limitations, 3D QVA has been developed to bridge the gap between 2D QVA and endovascular imaging. Thirty porcine femoral angiograms (common, profunda and superficial) with matching intravascular ultrasound (IVUS) pullbacks featuring variable degree of stenosis were analysed by 2D QVA, 3D QVA and quantitative IVUS. All 3 modalities provided similar data regarding the length of the investigated segment. Median lumen diameter was nearly identical in IVUS (4.69 mm) and in 3D QVA (4.76 mm) but quite a bit lower in 2D QVA (4.47 mm, Kruskal-Wallis test p = 0.1648). Lumen area measured in 2D QVA was lower than in IVUS and in 3D QVA. Lumen areas rendered by IVUS and 3D QVA were similar. Bland-Altman plots showed that the lowest differences were observed between IVUS and 3D QVA. IVUS and 3D QVA results were consistently higher than 2D QVA. 3D QVA is a useful surrogate of IVUS for precise luminal morphology measurements of peripheral arteries, rendering results that are much closer to IVUS than 2D QVA can provide.

Novel paclitaxel-eluting, biodegradable polymer coated stent in the treatment of de novo coronary lesions: a prospective multicenter registry.

OBJECTIVES: The purpose of the present study was to evaluate the efficacy and safety of a biodegradable polymer coated, paclitaxel eluting stent (Luc-Chopin(2)) based on 9-months angiographic and 12-months clinical follow-up results. BACKGROUND: First-generation drug-eluting stents utilize nonbioabsorbable polymeric coatings, whose persistent presence in the arterial wall may negatively affect long-term outcomes. Bioabsorbable coatings with a degradation period matched to that of the drug elution may be a better alternative, clinically and economically. METHODS: We conducted a prospective, multicenter first-in-man registry of a novel, locally developed, bioabsorbable-coated, paclitaxel-eluting coronary stent in 116 patients with single-lesion de novo coronary disease. RESULTS: Major adverse cardiac events occurred in 7.8% patients within 12 months. There were no late thrombotic events, death, stroke, or surgical revascularization in that period. There were two myocardial infarctions, one related to recent subacute stent thrombosis and another associated with restenosis. By 12 months, target vessel revascularization was performed in 7.8%; 2.9% were ischemia-driven and the rest were mandated at 9 months in accordance with a control angiography protocol. Core-lab assessed binary in-stent restenosis (> or =50% DS) was noted in 11.9% patients and mean late loss was 0.46 +/- 0.47 mm. CONCLUSIONS: This first-in-man experience obtained in a multicenter registry of real-world de novo lesions (almost half of lesions were class B2 or C by AHA classification) showed a favorable safety profile and acceptable efficacy through 12 months. Randomized comparison with a benchmark nonbioabsorbable polymer coated paclitaxel eluting stent should be undertaken to validate this initial positive experience.

Early abciximab administration before primary percutaneous coronary intervention improves infarct-related artery patency and left ventricular function in high-risk patients with anterior wall myocardial infarction: a randomized study.

BACKGROUND: Early abciximab administration before primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) is recommended in practice guidelines. However, the evidence supporting abciximab use before and during transfer for PPCI is limited. We investigated the effect of early abciximab administration on early reperfusion, ST-segment resolution, enzymatic infarct size, and left ventricular function in patients with first anterior wall STEMI. METHODS: A total of 59 nonshock patients with STEMI admitted <12 hours to remote hospitals with anticipated delay to PPCI of <90 minutes were randomly assigned to 2 study groups: 27 patients received abciximab before transfer to catheterization laboratory (Early group), and 32 patients received abciximab immediately before PPCI (Late group). RESULTS: Angiography revealed more frequent infarct-related artery patency in the Early group than in the Late group (TIMI 2 + 3: 48% vs 20%, P = .04). Better ST-segment resolution of >50% 60 minutes after PPCI was found in Early group than in the Late group (84% vs 56.7%, P = .04). The area under the curve for creatine kinase-MB indicated a significantly greater extent of myocardial injury in the Late group versus the Early group (8324 +/- 4185 vs 5938 +/- 3949 U/L . h, P = .04). There was a significant difference in the 30-day left ventricular end-systolic volume index (P = .02) and end-diastolic volume index (P = .05) in the echocardiography favoring the Early group. CONCLUSIONS: Early abciximab administration before transfer for PPCI in patients with first anterior wall STEMI results in more frequent infarct-related artery patency before PPCI, better myocardial tissue perfusion after PPCI, with lower enzymatic infarct size and lower degree of left ventricular remodeling during 30-day follow-up.

Assessment of culprit plaque temperature by intracoronary thermography appears inconclusive in patients with acute coronary syndromes.

OBJECTIVE: Safety and feasibility evaluation of intracoronary temperature measurements in patients with acute coronary syndromes (ACS) using a catheter based thermography system. METHODS AND RESULTS: Thermography was performed in 40 patients with ACS. A 3.5-F thermography catheter containing 5 thermocouples measuring vessel wall temperature, and 1 thermocouple measuring blood temperature (accuracy 0.05 degrees C) was used. Gradient (deltaTmax) between blood temperature (T(bl)) and the maximum wall temperature during pullback was measured. The device showed satisfactory safety in ACS. Only in 16 patients (40%) deltaTmax was > or = 0.1 degrees C. In 23 patients (57.5%) the highest deltaTmax was found in the culprit segment. DeltaTmax between culprit and adjacent non-culprit segments was observed in patients with transient blood flow interruption during thermography (0.11+/-0.03 versus 0.08+/-0.01; P=0.04), in contrast to patients with preserved flow (0.07+/-0.03 versus 0.06+/-0.02; P=0.058). CONCLUSIONS: The novel, technically sophisticated intracoronary thermography proved its safety and feasibility. However, we were not able to convincingly and consistently differentiate between different lesions at risk, despite a selection of lesions that should appear most distinct to differentiate. A systematic interruption of flow may be necessary to achieve diagnostic results consistently, although such requirement may unfavorably change the risk-to-benefit ratio of this developing technology.