The frozen lesion formation created by cryoballoon ablation, especially with non-occluded applications, has not been fully evaluated. This study aimed to validate the lesion size under different ...cryoballoon ablation settings: application duration, push-up technique, and laminar flow.
The frozen lesion size was evaluated immediately after ending the freezing with three different application durations (120, 150, and 180 seconds) in porcine hearts (N = 24). During the application, the push-up technique was applied at 10, 20, and 30 seconds after starting the freezing with or without laminar flow.
The lesion size was significantly correlated with the nadir balloon temperature (P<0.001). The lesion volume became significantly larger after 150 seconds than 120 seconds (1272mm3 versus 1709mm3, P = 0.004), but not after 150 seconds (versus 1876mm3 at 180 seconds, P = 0.29) with a comparable nadir balloon temperature. Furthermore, the lesion volume became significantly larger with the push-up technique with the largest lesion size with a 20-second push-up after the freezing (1193mm3 without the push-up technique versus 1585mm3 with a push-up at 10 seconds versus 1808mm3 with a push-up at 20 seconds versus 1714mm3 with a push-up at 30 seconds, P = 0.04). Further, the absence of laminar flow was not associated with larger lesion size despite a significantly lower nadir balloon temperature.
The frozen lesion size created by cryoballoon ablation became larger with longer applications at least 150 seconds and with a push-up technique especially at 20 seconds after the freezing.
The benefits of long-term oral β-blocker therapy in patients with ST-segment elevation myocardial infarction (STEMI) with mildly reduced left ventricular ejection fraction (LVEF; ≥40%) are still ...unknown. We sought to evaluate the efficacy of β-blocker therapy in patients with STEMI with mildly reduced LVEF. In the CAPITAL-RCT (Carvedilol Post-Intervention Long-Term Administration in Large-Scale Randomized Controlled Trial), patients with STEMI with successful percutaneous coronary intervention with an LVEF of ≥40% were randomly assigned to carvedilol or no β-blocker therapy. Among 794 patients, 280 patients had an LVEF of <55% at baseline (mildly reduced LVEF stratum), whereas 514 patients had an LVEF of ≥55% at baseline (normal LVEF stratum). The primary end point was a composite of all-cause death, myocardial infarction, hospitalization for acute coronary syndrome, and hospitalization for heart failure, and the secondary end point was a cardiac composite outcome: a composite of cardiac death, myocardial infarction, and hospitalization for heart failure. The median follow-up period was 3.7 years. The lower risk of carvedilol therapy relative to no β-blocker therapy was not significant for the primary end point in either the mildly reduced or normal LVEF strata. However, it was significant for the cardiac composite end point in the mildly reduced LVEF stratum (0.82/100 person-years vs 2.59/100 person-years, hazard ratio 0.32 0.10 to 0.99, p = 0.047) but not in the normal LVEF stratum (1.48/100 person-years vs 1.06/100 person-years, hazard ratio 1.39 0.62 to 3.13, p = 0.43, p for interaction = 0.04). In conclusion, long-term carvedilol therapy in patients with STEMI with primary percutaneous coronary intervention might be beneficial for preventing cardiac-related events in those with a mildly reduced LVEF.
Despite its recommendation by the current guidelines, the role of long-term oral beta-blocker therapy has never been evaluated by randomized trials in uncomplicated ST-segment elevation myocardial ...infarction (STEMI) patients without heart failure, left ventricular dysfunction or ventricular arrhythmia who underwent primary percutaneous coronary intervention (PCI).
In a multi-center, open-label, randomized controlled trial, STEMI patients with successful primary PCI within 24 hours from the onset and with left ventricular ejection fraction (LVEF) ≥40% were randomly assigned in a 1-to-1 fashion either to the carvedilol group or to the no beta-blocker group within 7 days after primary PCI. The primary endpoint is a composite of all-cause death, myocardial infarction, hospitalization for heart failure, and hospitalization for acute coronary syndrome. Between August 2010 and May 2014, 801 patients were randomly assigned to the carvedilol group (N = 399) or the no beta-blocker group (N = 402) at 67 centers in Japan. The carvedilol dose was up-titrated from 3.4±2.1 mg at baseline to 6.3±4.3 mg at 1-year. During median follow-up of 3.9 years with 96.4% follow-up, the cumulative 3-year incidences of both the primary endpoint and any coronary revascularization were not significantly different between the carvedilol and no beta-blocker groups (6.8% and 7.9%, P = 0.20, and 20.3% and 17.7%, P = 0.65, respectively). There also was no significant difference in LVEF at 1-year between the 2 groups (60.9±8.4% and 59.6±8.8%, P = 0.06).
Long-term carvedilol therapy added on the contemporary evidence-based medications did not seem beneficial in selected STEMI patients treated with primary PCI.
CAPITAL-RCT (Carvedilol Post-Intervention Long-Term Administration in Large-scale Randomized Controlled Trial) ClinicalTrials.gov.number, NCT 01155635.
Abstract Background Little is known about the prognostic implications of anemia in patients undergoing elective percutaneous coronary intervention (PCI), especially when they have coexisting chronic ...kidney disease (CKD). Methods We identified 7299 patients who underwent elective PCI from the CREDO-Kyoto registry cohort-2. The primary outcome was 3-year major adverse cardiac events (MACE); composite of all cause death, heart failure hospitalization, and myocardial infarction. Results In total, 1466 patients (20.0%) had mild anemia (hemoglobin = 11.0–11.9 g/dL for women and 11.0–12.9 g/dL for men), and 740 patients (10.1%) had moderate-to-severe anemia (hemoglobin < 11.0 g/dL both for women and for men). Compared to the no-anemia group, cumulative incidence of MACE was significantly higher in the mild and moderate-to-severe anemia groups (7.9%, 20.1%, and 34.2%, respectively). The adjusted hazard ratios of mild and moderate-to-severe anemia versus no-anemia for MACE were 1.77 (95% confidence interval: 1.47–2.15) and 2.53 (95% confidence interval: 2.03–3.14), respectively. In a subgroup analysis, significantly higher risk for MACE was consistently observed with mild and moderate-to-severe anemia both in patients with and without CKD. The risk for MACE showed an accretive increment with exacerbation in either the renal function or anemia (interaction p < 0.001). Conclusions Even mild anemia was associated with significantly worse 3-year clinical outcomes in patients who underwent elective PCI. Coexisting CKD additively increased the risk for MACE in these patients.
Objectives
We developed a novel guidewire‐integrated filter device with a handy‐folding system (IFD: Inoue filter device). In vitro and in vivo studies were conducted to evaluate the feasibilityof ...the IFD.
Background
Although distal atheromatous and thrombotic embolizations remain unresolved critical issues during catheter interventions, distal protection devices are infrequently used partly because of reduced lower maneuverability.
Methods
In the in vitro experiment, we created an experimental circulation model composed of silicone latex tubes, a reservoir, and a roller pump. After the filter device was deployed in the tube, polystyrene fluorescent microspheres were injected and the capture rate was calculated. Ten trials were performed using the IFD and Spider FX. In the in vivo study, five independent operators deployed, and they retrieved the IFD in swine common iliac and internal carotid arteries. The procedural success rate as well as the delivery and retrieval time was evaluated.
Results
In the in vitro study, the mean capture rate was 94% and 35% in the IFD and Spider groups, respectively. In the in vivo study, all procedures were successful, with no complications. The mean delivery time was 281 ± 87 s and 194 ± 67 s and the mean retrieval time was 24 ± 9 and 13 ±1 s in the left internal carotid and the left common iliac arteries, respectively.
Conclusion
Although further studies and improvements are required, the study results indicate that the IFD is feasible.
Abstract Background The influence of β-blocker therapy on prognosis in patients with coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI) has not been fully explored. ...Methods and results We identified 5288 CAD patients who did not have myocardial infarction (MI) or heart failure (HF) but underwent PCI from a large multi-center registry enrolling consecutive patients undergoing first coronary revascularization from 2005 to 2007. The primary outcome was a composite endpoint of cardiac death and/or MI (cardiac death/MI) at 3 years after hospital discharge for PCI. β-blockers were prescribed in 1117 patients (β group, 21.1%) at discharge, while 4171 patients did not (no-β group, 78.9%). Patients in the β group more often had hypertension, multivessel disease, use of statin and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, but less often had chronic obstructive pulmonary disease. The 3-year incidence of cardiac death/MI was higher in the β group (4.9% vs. 3.4%, log-rank p = 0.02). After adjusting for potential confounders, β-blocker therapy was associated with significantly increased risk for cardiac death/MI (hazard ratio 1.48, 95% confidence interval 1.05–2.10, p = 0.02). Conclusions β-blocker therapy was associated with worse 3-year clinical outcomes in CAD patients who underwent PCI but had no history of MI or HF. Randomized trials are warranted to identify appropriate subsets of patients who could truly benefit from long-term use of β-blockers in this setting.
Background: Conventional exercise training (ET) for elderly patients with heart failure (HF) includes low-intensity stretching and gait training. The effects of 2 types of low-intensity ET - ...machine-assisted cycling and conventional ET - on exercise capacity and endothelial function of elderly patients with HF was investigated in the present study. Methods and Results: Twenty-seven elderly patients with HF (mean age: 79.5 years) were randomly assigned to either a machine-assisted cycling group or a conventional ET group. At baseline and after 2 weeks of ET, all patients were tested for 6-minute walk distance (6MWD) and digital reactive hyperemia-peripheral arterial tonometry (RH-PAT). After 2 weeks of ET, a significant increase in 6MWD was observed in both groups with no significant difference between the groups. RH-PAT index significantly increased in patients aged ≤80 (1.55±0.33 to 1.93±0.62, P=0.035) and a trend toward increase in RH-PAT index in the machine-assisted cycling group was observed (1.59±0.52 to 1.93±0.63, P=0.053), although no change was observed in the conventional ET group. In the multivariate model, patients’ age and machine-assisted cycling were associated with the increases in RH-PAT index (P<0.05). Conclusions: Machine-assisted cycling appeared to be as effective as conventional ET on exercise capacity in elderly patients with HF. Additionally, machine-assisted cycling has the potential to improve endothelial function in these patients. (Circ J 2012; 76: 1889–1894)
We aimed to investigate the effectiveness of a scoring balloon catheter in expanding a circumferentially calcified lesion compared to a conventional balloon catheter using an in vitro experiment ...setting and elucidate the underlying mechanisms of this ability using a finite element analysis. True efficacy of the scoring device and the underlying mechanisms for heavily calcified coronary lesions are unclear. We employed a Scoreflex scoring balloon catheter (OrbusNeich, Hong Kong, China). The ability of Scoreflex to dilate a calcified lesion was compared with a conventional balloon catheter using 3 different sized calcium tubes. The thickness of the calcium tubes were 2.0, 2.25, and 2.5 mm. The primary endpoints were the successful induction of cracks in the calcium tubes and the inflation pressures required for inducing cracks. The inflation pressure required for cracking the calcium tubes were consistently lower with Scoreflex (
p
< 0.05, Student
t
test). The finite element analysis revealed that the first principal stress applied to the calcified plaque was higher by at least threefold when applying the balloon catheter with scoring elements. A scoring balloon catheter can expand a calcified lesion with lower pressure than that of a conventional balloon. The finite element analysis revealed that the concentration of the stress observed in the outside of the calcified plaque just opposite to the scoring element is the underlying mechanism of the increased ability of Scoreflex to dilate the calcified lesion.
The main drawback of current available drug coated balloons (DCB) is that a certain percentage of the coated drug is lost in the bloodstream during its delivery to the target lesion. We integrated ...the nanoparticle-mediated drug delivery technology and polydimethylsiloxane (PDMS) as a new excipient to facilitate an efficient drug delivery and uptake by endothelial cells. The present study aimed to evaluate the efficacy of the new DCB.
The novel DCB were coated with 5.6mg of paclitaxel–incorporated nanoparticles using PDMS. The efficacy of the new DCB was examined in rabbit iliac stent model (n=12) and in the swine in-stent restenosis model (n=8) by quantitative coronary angiography (QCA) and optical coherence tomography (OCT). At 28days follow-up in the swine in-stent restenosis model, the area stenosis was significantly lower in DCB group as compared with that of the control group in OCT analysis (0.31±0.05 vs 0.49±0.06, p=0.04) though there was no significant differences observed in the rabbit iliac stent model in QCA and OCT analysis.
The study results indicated that the paclitaxel-incorporated nanoparticle-coated balloon using PDMS has an inhibitory effect for the proliferation of smooth muscle cell in a swine coronary in-stent restenosis model.
•We developed a novel paclitaxel-incorporated nanoparticle-coated balloon.•The novel drug-coated balloon showed that tissue concentrations of paclitaxel were within a therapeutic range.•The novel drug-coated balloon inhibited smooth muscle cell proliferation in a swine coronary stent-restenosis model.
Abstract Background Transcatheter aortic valve implantation (TAVI) is an established therapy for patients who are inoperable or at high risk for open heart surgery. The retrograde transfemoral ...approach is the most widely used and is the first choice in TAVI. However, existence of peripheral vascular disease or a small iliofemoral artery often limits the application of the transfemoral approach. Transvenous antegrade transseptal TAVI is an attractive option, but has already been abandoned due to its technical complexities. Methods and results We have previously described a novel technique to simplify antegrade transseptal balloon aortic valvuloplasty, which utilizes a custom-made Inoue balloon catheter with two stylets. The technique is named as the looped Inoue balloon technique, and its feasibility and efficacy were proven in an animal model and a clinical case. We applied this technique to TAVI. The present study aimed to assess the feasibility of the looped Inoue balloon technique for TAVI in two healthy pigs. The valve implantation was successful in both pigs, although the pigs died soon after the implantation (2 and 24 h). The causes of death were access site bleeding (Case 1) and migration of the prosthetic valve (Case 2). Conclusions Although several improvements and further studies are required, the study results indicate that antegrade TAVI using the looped Inoue balloon technique is feasible.
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