Ameliorative impacts of sodium humate on heat-stressed laying Japanese quail (Coturnix coturnix Japonica).

A total of 300 laying Japanese quails (230.10 ± 20 g body weight) divided into four groups (15 birds in 5 replicates/group) were used to examine the impacts of dietary sodium humate (SH) supplementation at levels of 0% (control diet), 0.2%, 0.4% and 0.6% on egg variables and physiological merits of laying quails for 10 weeks under heat stress conditions (15 June and 23 August 2021). Results showed 0.4% SH increased (p < 0.05) weight (12.27 vs. 11.91 g), production (79.84% vs. 69.20%), mass (597.13 vs. 510.48 g) and brokenness (2.8% vs. 5.4%) of eggs as compared to control. Egg shape, shell thickness, shell strength and cholesterol content as well as feed conversion ratio were higher (80.2, 295.8 µm, 1.468 kg/cm,2 11.08 mg/g and 2.69, p < 0.05) in 0.4% SH than in control group (75.2, 279.0 µm, 1.304 kg/cm,2  14.94 mg/g and 2.76). Feed intake, percentages of eggs' shells, yolk, albumen and serum biochemistry (total protein, albumin, AST and HDL) were not altered with the dietary SH. Birds fed on SH diets showed higher levels of globulin, calcium and phosphorus, as well as lower contents of albumin/globulin ratio, triglycerides, cholesterol, corticosterone compared with the control. Regression analysis of antioxidants expected higher total antioxidant capacity (TAC), superoxide dismutase, glutathione peroxidase at 0.35%, and glutathione at 0.40% SH, while the lowest concentration of malondialdehyde was computed at 0.45%. Similarly, immunoglobulins (IgG and IgM) maximum values were determined at 0.35% and 0.40% levels. Moreover, the concentration of tumour necrosis factor-alpha increased (p < 0.05) in all SH levels as compared to the control group. It is conceivable to conclude that the dietary implementation of SH at a level of 0.4% improved egg variables and well-being aspects of laying quail exposed to heat stress conditions.

Impacts of different antioxidants sources on semen quality and sperm fertilizing ability of Muscovy ducks under high ambient temperature.

The potentiality of coenzyme Q10 (CoQ10), D-Aspartic acids (D-Asp), Maca or vitamin C, as antioxidant agents, to reduce negative impacts of high ambient temperature on semen quality, oxidative capacity and fertility of Muscovy ducks was investigated. Seventy-five Muscovy males (34-wk of age) were distributed randomly into five experimental groups of fifteen ducks each. The first group was fed a basal diet without supplementation and served as a control. The other four groups were fed a basal diet supplemented with 400 mg CoQ10, 400 mg D-Asp, 500 mg Maca and 200 mg vitamin C (ascorbic acid) per kg diet for 17 consecutive weeks under high ambient temperature conditions. The dietary inclusion of antioxidants significantly maintains better semen variables and a higher fertility rate either for fresh or preserved semen. Among the tested antioxidants, the Maca group showed the best status and outperformed the others in terms of motility, viability, sperm cell concentration, intact acrosome and membrane integrity percentages, total proteins, total antioxidants capacity, glutathione peroxidase, superoxide dismutase (SOD), malondialdehyde (MDA), testosterone, and the fertility rate for the fresh semen, as well as, forward motility, SOD and MDA for the preserved semen. The CoQ10 showed similar results to Maca in some measurements. Conversely, the basal diet had the poorest performance in all examined variables. The dietary incorporation of antioxidants (Maca or CoQ10) enhances fresh and preserved semen quantity and quality, as well as the fertility rate of Muscovy males under high ambient temperature conditions.

Percutaneous closure of patent foramen ovale in cryptogenic embolism.

BACKGROUND: The options for secondary prevention of cryptogenic embolism in patients with patent foramen ovale are administration of antithrombotic medications or percutaneous closure of the patent foramen ovale. We investigated whether closure is superior to medical therapy. METHODS: We performed a multicenter, superiority trial in 29 centers in Europe, Canada, Brazil, and Australia in which the assessors of end points were unaware of the study-group assignments. Patients with a patent foramen ovale and ischemic stroke, transient ischemic attack (TIA), or a peripheral thromboembolic event were randomly assigned to undergo closure of the patent foramen ovale with the Amplatzer PFO Occluder or to receive medical therapy. The primary end point was a composite of death, nonfatal stroke, TIA, or peripheral embolism. Analysis was performed on data for the intention-to-treat population. RESULTS: The mean duration of follow-up was 4.1 years in the closure group and 4.0 years in the medical-therapy group. The primary end point occurred in 7 of the 204 patients (3.4%) in the closure group and in 11 of the 210 patients (5.2%) in the medical-therapy group (hazard ratio for closure vs. medical therapy, 0.63; 95% confidence interval [CI], 0.24 to 1.62; P=0.34). Nonfatal stroke occurred in 1 patient (0.5%) in the closure group and 5 patients (2.4%) in the medical-therapy group (hazard ratio, 0.20; 95% CI, 0.02 to 1.72; P=0.14), and TIA occurred in 5 patients (2.5%) and 7 patients (3.3%), respectively (hazard ratio, 0.71; 95% CI, 0.23 to 2.24; P=0.56). CONCLUSIONS: Closure of a patent foramen ovale for secondary prevention of cryptogenic embolism did not result in a significant reduction in the risk of recurrent embolic events or death as compared with medical therapy. (Funded by St. Jude Medical; ClinicalTrials.gov number, NCT00166257.).

Rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: Two-year clinical outcome of the randomized ROTAXUS trial.

BACKGROUND: In the randomized ROTAXUS trial, routine lesion preparation of complex calcified coronary lesions using rotational atherectomy (RA) prior to paclitaxel-eluting stent implantation did not reduce the primary endpoint of angiographic late lumen loss at 9 months compared to stenting without RA. So far, no long-term data of prospective head-to-head comparisons between both treatment strategies have been reported. METHODS AND RESULTS: ROTAXUS randomly assigned patients with complex calcified coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120). The primary endpoint of the current analysis was the occurrence of major adverse cardiac events (MACE) at 2-year follow-up defined as the composite of death, myocardial infarction, and target vessel revascularization (TVR). At 2 years, MACE occurred in 32 patients in the RA group and 37 patients in the standard therapy group (29.4% vs. 34.3%, P = 0.47). The rates of death (8.3% vs. 7.4%, P = 1.00), myocardial infarction (8.3% vs. 6.5%, P = 0.80), target lesion revascularization (TLR, 13.8% vs. 16.7%, P = 0.58), and TVR (19.3% vs. 22.2%, P = 0.62) were similar in both groups. CONCLUSION: Despite high rates of initial angiographic success, nearly one third of patients enrolled in ROTAXUS experienced MACE within 2-year follow-up, with no differences between patients treated with or without RA.

Svelte integrated delivery system performance examined through diagnostic catheter delivery: the SPEED registry.

AIMS: The multi-center SPEED registry evaluated the procedural success and in-hospital clinical outcomes of direct stenting with the Svelte 'all-in-one' coronary stent Integrated Delivery System (IDS) through diagnostic catheters to identify the clinical indications for which this approach is appropriately suited. METHODS & RESULTS: Forty-eight (48) patients with 54 lesions of lengths ≤20 mm and RVD 2.5-3.5 mm were targeted for direct stenting through diagnostic catheters (4-6F) via radial or femoral approach. Procedural characteristics early in an investigator's experience (28 lesions) were compared with outcomes following experience (26 lesions). Procedure, device and strategy success were realized in 54 (100%), 50 (93%) and 46 (85%) lesions, respectively, with strategy success significantly related to RVD (P = 0.05), lesion location (P = 0.01), and diagnostic catheter size (P = 0.05). Significant improvement in crossing and intervention time and trends toward improvement in device and strategy success, reductions in procedure and radiation time and contrast use were observed. CONCLUSIONS: Direct stenting through diagnostic catheters via radial or femoral approach using the Svelte IDS is feasible and associated with good in-hospital outcomes. This approach offers the attractive option of assessing lesions via diagnostic catheter and, depending upon vessel anatomy and lesion morphology, continuing with ad-hoc interventional treatment using the same diagnostic catheter. Improvements in strategy success and procedural efficiencies, based on operator experience, facilitate catheter downsizing and reduce intervention time, ancillary product use and overall procedure costs. © 2014 Wiley Periodicals, Inc.

Coronary artery disease severity and aortic stenosis: clinical outcomes according to SYNTAX score in patients undergoing transcatheter aortic valve implantation.

AIM: The aim of this study was to evaluate whether coronary artery disease (CAD) severity exerts a gradient of risk in patients with aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: A total of 445 patients with severe AS undergoing TAVI were included into a prospective registry between 2007 and 2012. The preoperative SYNTAX score (SS) was determined from baseline coronary angiograms. In case of revascularization prior to TAVI, residual SS (rSS) was also determined. Clinical outcomes were compared between patients without CAD (n = 158), patients with low SS (0-22, n = 207), and patients with high SS (SS > 22, n = 80). The pre-specified primary endpoint was the composite of cardiovascular death, stroke, or myocardial infarction (MI). At 1 year, CAD severity was associated with higher rates of the primary endpoint (no CAD: 12.5%, low SS: 16.1%, high SS: 29.6%; P = 0.016). This was driven by differences in cardiovascular mortality (no CAD: 8.6%, low SS: 13.6%, high SS: 20.4%; P = 0.029), whereas the risk of stroke (no CAD: 5.1%, low SS: 3.3%, high SS: 6.7%; P = 0.79) and MI (no CAD: 1.5%, low SS: 1.1%, high SS: 4.0%; P = 0.54) was similar across the three groups. Patients with high SS received less complete revascularization as indicated by a higher rSS (21.2 ± 12.0 vs. 4.0 ± 4.4, P < 0.001) compared with patients with low SS. High rSS tertile (> 14) was associated with higher rates of the primary endpoint at 1 year (no CAD:12.5%, low rSS: 16.5%, high rSS: 26.3%, P = 0.043). CONCLUSIONS: Severity of CAD appears to be associated with impaired clinical outcomes at 1 year after TAVI. Patients with SS > 22 receive less complete revascularization and have a higher risk of cardiovascular death, stroke, or MI than patients without CAD or low SS.

Amplatzer left atrial appendage occlusion through a patent foramen ovale.

OBJECTIVES: To assess feasibility and outcomes of left atrial appendage (LAA) closure when using a patent foramen ovale (PFO) for left atrial access. BACKGROUND: Because of the fear of entering the left atrium too high, using a PFO for left atrial access during LAA occlusion (LAAO) is generally discouraged. We report our single-center experience using a concomitant PFO for LAAO, thereby avoiding transseptal puncture. METHODS: LAAO was performed with local anesthesia and fluoroscopic guidance only (no echocardiography). The Amplatzer Cardiac Plug (ACP) was used in all patients. After LAAO, the PFO was closed at the same sitting, using an Amplatzer occluder through the ACP delivery sheath. Patients were discharged the same or the following day on dual antiplatelet therapy for 1-6 months, at which time a follow-up transesophageal echocardiogram (TEE) was performed. RESULTS: In 49 (96%) of 51 patients (35 males, age 70.9 ± 11.9 years), LAAO was successful using the PFO for left atrial access. In one patient, a long tunnel PFO precluded LAAO, which was performed via a more caudal transseptal puncture. In a second patient, a previously inserted ASD occluder precluded LAAO, which was abandoned because of pericardial bleeding. PFO closure was successful in all patients. Follow-up TEE was performed in 43 patients 138 ± 34 days after the procedure. It showed proper sitting of both devices in all patients. CONCLUSIONS: Using a PFO for LAAO had a high success rate and could be the default access in all patients with a PFO, potentially reducing procedural complications arising from transseptal puncture.

Clinical outcomes of patients with low-flow, low-gradient, severe aortic stenosis and either preserved or reduced ejection fraction undergoing transcatheter aortic valve implantation.

AIMS: Our aim was to evaluate the invasive haemodynamic indices of high-risk symptomatic patients presenting with 'paradoxical' low-flow, low-gradient, severe aortic stenosis (AS) (PLF-LG) and low-flow, low-gradient severe AS (LEF-LG) and to compare clinical outcomes following transcatheter aortic valve implantation (TAVI) among these challenging AS subgroups. METHODS AND RESULTS: Of 534 symptomatic patients undergoing TAVI, 385 had a full pre-procedural right and left heart catheterization. A total of 208 patients had high-gradient severe AS [HGAS; mean gradient (MG) ≥40 mmHg], 85 had PLF-LG [MG ≤ 40 mmHg, indexed aortic valve area [iAVA] ≤0.6 cm(2) m(-2), stroke volume index ≤35 mL/m(2), ejection fraction (EF) ≥50%], and 61 had LEF-LG (MG ≤ 40 mmHg, iAVA ≤0.6 cm(2) m(-2), EF ≤40%). Compared with HGAS, PLF-LG and LEF-LG had higher systemic vascular resistances (HGAS: 1912 ± 654 vs. PLF-LG: 2006 ± 586 vs. LEF-LG: 2216 ± 765 dyne s m(-5), P = 0.007) but lower valvulo-arterial impedances (HGAS: 7.8 ± 2.7 vs. PLF-LG: 6.9 ± 1.9 vs. LEF-LG: 7.7 ± 2.5 mmHg mL(-1) m(-2), P = 0.027). At 30 days, no differences in cardiac death (6.5 vs. 4.9 vs. 6.6%, P = 0.90) or death (8.4 vs. 6.1 vs. 6.6%, P = 0.88) were observed among HGAS, PLF-LG, and LEF-LG groups, respectively. At 1 year, New York Heart Association functional improvement occurred in most surviving patients (HGAS: 69.2% vs. PLF-LG: 71.7% vs. LEF-LG: 89.3%, P = 0.09) and no significant differences in overall mortality were observed (17.6 vs. 20.5 vs. 24.5%, P = 0.67). Compared with HGAS, LEF-LG had a higher 1 year cardiac mortality (adjusted hazard ratio 2.45, 95% confidence interval 1.04-5.75, P = 0.04). CONCLUSION: TAVI in PLF-LG or LEF-LG patients is associated with overall mortality rates comparable with HGAS patients and all groups profit symptomatically to a similar extent.

Long-term clinical outcome of rotational atherectomy followed by drug-eluting stent implantation in complex calcified coronary lesions.

OBJECTIVES: To assess long-term outcome after rotational atherectomy (RA) is followed by drug-eluting stent (DES) implantation in complex calcified coronary lesions. BACKGROUND: RA can favorably modify heavily calcified coronary lesions, but long-term outcome is poor when it is used as a stand-alone therapy or combined with bare-metal stents. DES have reduced rates of restenosis in a wide range of patient and lesion subsets, but little information is available on long-term clinical outcome when RA is followed by DES implantation (Rota-DES) in complex calcified lesions. METHODS AND RESULTS: Two hundred and five patients with de novo complex calcified coronary lesions treated with Rota-DES were analyzed. Mean age was 69.7 ± 9.3 years, 63 patients (31%) had diabetes mellitus and 21 patients (10%) had chronic renal failure. Total stent length/patient was 32 mm. The majority of patients were treated with paclitaxel-eluting stents (64%) or sirolimus-eluting stents (30%). Angiographic success rate was 98%. The incidence of in-hospital major adverse cardiac events (MACE), defined as death, myocardial infarction (MI), and target vessel revascularization (TVR), was 4.4%. Long-term follow-up was available for 188 patients (92%). At a median follow-up period of 15 months (range, 1-84), the cumulative incidence of MACE (Kaplan-Meier estimate) was 17.7%. Death occurred in 4.4%, MI in 3.4%, TVR in 9.9%, and target lesion revascularization (TLR) in 6.8%. One definite (0.5%) and one probable (0.5%) stent thrombosis were observed. In a multivariate analysis, low ejection fraction (<40%) was the only independent predictor of MACE, and both age and diabetes were independent predictors of TLR. CONCLUSION: This study represents the largest European data set of patients treated with RA in the DES era. RA followed by DES implantation in calcified coronary lesions appears to be feasible and effective, with a high rate of procedural success and low incidence of TLR and MACE at long term considering this complex patient and lesion subset.

Amplatzer left atrial appendage occlusion: single center 10-year experience.

OBJECTIVES: To report a 10-year single center experience with Amplatzer devices for left atrial appendage (LAA) occlusion. BACKGROUND: Intermediate-term outcome data following LAA occlusion are scarce. METHODS: Short- and intermediate-term outcomes of patients who underwent LAA occlusion were assessed. All procedures were performed under local aesthesia without transesophageal echocardiography. Patients were discharged on acetylsalicylic acid and clopidogrel for 1-6 months. RESULTS: LAA occlusion was attempted in 152 patients (105 males, age 72 ± 10 years, CHA2 DS2 -Vasc-score 3.4 ± 1.7, HAS-BLED-score 2.4 ± 1.2). Nondedicated devices were used in 32 patients (21%, ND group) and dedicated Amplatzer Cardiac Plugs were used in 120 patients (79%, ACP group). A patent foramen ovale or atrial septal defect was used for left atrial access and closed at the end of LAA occlusion in 40 patients. The short-term safety endpoints (procedural complications, bleeds) occurred in 15 (9.8%) and the efficacy endpoints (death, stroke, systemic embolization) in 0 patients. Device embolization occurred more frequently in the ND as compared to the ACP group (5 patients or 12% vs. 2 patients or 2%). Mean intermediate-term follow up of the study population was 32 months (range 1-120). Late deaths occurred in 15 patients (5 cardiovascular, 7 noncardiac, 3 unexplained). Neurologic events occurred in 2, peripheral embolism in 1, and major bleeding in 4 patients. The composite efficacy and safety endpoint occurred in 7% and 12% of patients. CONCLUSION: LAA closure may be a good alternative to oral anticoagulation. This hypothesis needs to be tested in a randomized clinical trial to ensure that all potential biases of this observational study are accounted for.

New approach to direct stenting using a novel "all-in-one" coronary stent system via 5 French diagnostic catheters: a pilot study.

OBJECTIVES: We sought to evaluate the strategy success and short term clinical outcomes of direct stenting via 5 French (F) diagnostic catheters using a novel bare metal stent with integrated delivery system (IDS) (Svelte Medical Systems, New Providence, NJ) and compare the results to a conventionally treated matched group. METHODS: Fifteen consecutive patients with lesions deemed suitable for direct stenting using a bare metal stent were included. The primary endpoint was the strategy success defined as the ability to successfully treat a target lesion via a 5 F diagnostic catheter with a good angiographic result (TIMI III flow, residual stenosis ≤20%). Procedure and fluoroscopy times, contrast agent use, cost, and short-term clinical outcomes were compared to a matched group treated via conventional stenting. RESULTS: The primary endpoint was reached in 14/15 patients (93%). There were no significant differences in procedural (58.6 min ± 12.7 vs. 57.4 min ± 14.2) or fluoroscopy times (10.0 min ± 4.3 vs.10.1 min ± 3.9) or contrast agent use (193.7 ml ± 54.8 vs. 181.4 ml ± 35.6). However, there were significant reductions in materials used in the study group compared to the control group equating to cost savings of almost US $600 per case (US $212.44 ± 258.09 vs. US $804.69 ± 468.11; P = 0.001). CONCLUSIONS: Direct stenting using a novel bare metal stent with an IDS via 5 F diagnostic catheters is a viable alternative to conventional stenting in selected patients and is associated with significant cost savings.

Edema is a sign of early acute myocardial infarction on post-mortem magnetic resonance imaging.

The aim of this study was to investigate if acute myocardial infarction can be detected by post-mortem cardiac magnetic resonance (PMMR) at an earlier stage than by traditional autopsy, i.e., within less than 4 h after onset of ischemia; and if so, to determine the characteristics of PMMR findings in early acute infarcts. Twenty-one ex vivo porcine hearts with acute myocardial infarction underwent T2-weighted cardiac PMMR imaging within 3 h of onset of iatrogenic ischemia. PMMR imaging findings were compared to macroscopic findings. Myocardial edema induced by ischemia and reperfusion was visible on PMMR in all cases. Typical findings of early acute ischemic injury on PMMR consist of a central zone of intermediate signal intensity bordered by a rim of increased signal intensity. Myocardial edema can be detected on cardiac PMMR within the first 3 h after the onset of ischemia in porcine hearts. The size of myocardial edema reflects the area of ischemic injury in early acute (per-acute) myocardial infarction. This study provides evidence that cardiac PMMR is able to detect acute myocardial infarcts at an earlier stage than traditional autopsy and routine histology.

Impacts of algae supplements (Arthrospira & Chlorella) on growth, nutrient variables, intestinal efficacy, and antioxidants in New Zealand white rabbits.

An 8-week trial to examine the impacts of Arthrospira platensis and Chlorella vulgaris on the growth, nutrient aspects, intestinal efficacy, and antioxidants of 75 New Zealand white male rabbits (initial body weight = 665.93 ± 15.18 g). Herein the study was designed in one-way ANOVA to compare the effects of the two algae species with two levels of supplementations in the feeds of New Zealand white rabbits. The rabbits were divided into five groups (n = 15/group), where the first group was allocated as the control group (Ctrl) while the second and third groups received A. platensis at 300 or 500 mg/kg diet (Ap300 or Ap500). The fourth and fifth groups fed C. vulgaris at 300 or 500 mg/kg diet (Ch300 or Ch500). The basal diet rabbits exhibited the lowest values of weight, lipase, protease, and the highest feed conversion ratio, which improved noticeably with algae addition, particularly with Ap500, Ch300, and Ch500. All tested groups showed normal intestinal structure. Amylase potency, hematological indicators, and serum biochemistry revealed non-significant variation except for a higher serum total protein and lower total cholesterol in algal groups. The best GPx existed in groups fed algal diets, while favorable SOD and CAT efficiency occurred at the higher level of Arthrospira and both levels of Chlorella. In conclusion, incorporating Arthrospira or Chlorella in the diet of New Zealand white rabbits improved performance, nutrient utilization, intestinal efficacy, and antioxidants. Arthrospira (Ap500) and Chlorella (Ch300 or Ch500) have almost the same beneficial effect on rabbit performance.

Double-vessel coronary stenting via 5 French diagnostic catheters.

The authors report on the use of 5 French diagnostic catheters to deliver a stent-on-a-wire system during a double vessel coronary intervention.

Effect of biolimus-eluting stents with biodegradable polymer vs bare-metal stents on cardiovascular events among patients with acute myocardial infarction: the COMFORTABLE AMI randomized trial.

CONTEXT: The efficacy and safety of drug-eluting stents compared with bare-metal stents remains controversial in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). OBJECTIVE: To compare stents eluting biolimus from a biodegradable polymer with bare-metal stents in primary PCI. DESIGN, SETTING, AND PATIENTS: A prospective, randomized, single-blinded, controlled trial of 1161 patients presenting with STEMI at 11 sites in Europe and Israel between September 19, 2009, and January 25, 2011. Clinical follow-up was performed at 1 and 12 months. INTERVENTION: Patients were randomized 1:1 to receive the biolimus-eluting stent (n = 575) or the bare-metal stent (n = 582). MAIN OUTCOME MEASURES: Primary end point was the rate of major adverse cardiac events, a composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization at 1 year. RESULTS: Major adverse cardiac events at 1 year occurred in 24 patients (4.3%) receiving biolimus-eluting stents with biodegradable polymer and 49 patients (8.7%) receiving bare-metal stents (hazard ratio [HR], 0.49; 95% CI, 0.30-0.80; P = .004). The difference was driven by a lower risk of target vessel-related reinfarction (3 [0.5%] vs 15 [2.7%]; HR, 0.20; 95% CI, 0.06-0.69; P = .01) and ischemia-driven target-lesion revascularization (9 [1.6%] vs 32 [5.7%]; HR, 0.28; 95% CI, 0.13-0.59; P < .001) in patients receiving biolimus-eluting stents compared with those receiving bare-metal stents. Rates of cardiac death were not significantly different (16 [2.9%] vs 20 [3.5%], P = .53). Definite stent thrombosis occurred in 5 patients (0.9%) treated with biolimus-eluting stents and 12 patients (2.1%; HR, 0.42; 95% CI, 0.15-1.19; P = .10) treated with bare-metal stents. CONCLUSION: Compared with a bare-metal stent, the use of biolimus-eluting stents with a biodegradable polymer resulted in a lower rate of the composite of major adverse cardiac events at 1 year among patients with STEMI undergoing primary PCI. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00962416.

Bivalirudin versus unfractionated heparin during percutaneous coronary intervention.

BACKGROUND: Whether bivalirudin is superior to unfractionated heparin in patients with stable or unstable angina who undergo percutaneous coronary intervention (PCI) after pretreatment with clopidogrel is unknown. METHODS: We enrolled 4570 patients with stable or unstable angina (with normal levels of troponin T and creatine kinase MB) who were undergoing PCI after pretreatment with a 600-mg dose of clopidogrel at least 2 hours before the procedure; 2289 patients were randomly assigned in a double-blind manner to receive bivalirudin, and 2281 to receive unfractionated heparin. The primary end point was the composite of death, myocardial infarction, urgent target-vessel revascularization due to myocardial ischemia within 30 days after randomization, or major bleeding during the index hospitalization (with a net clinical benefit defined as a reduction in the incidence of the end point). The secondary end point was the composite of death, myocardial infarction, or urgent target-vessel revascularization. RESULTS: The incidence of the primary end point was 8.3% (190 patients) in the bivalirudin group as compared with 8.7% (199 patients) in the unfractionated-heparin group (relative risk, 0.94; 95% confidence interval [CI], 0.77 to 1.15; P=0.57). The secondary end point occurred in 134 patients (5.9%) in the bivalirudin group and 115 patients (5.0%) in the unfractionated-heparin group (relative risk, 1.16; 95% CI, 0.91 to 1.49; P=0.23). The incidence of major bleeding was 3.1% (70 patients) in the bivalirudin group and 4.6% (104 patients) in the unfractionated-heparin group (relative risk, 0.66; 95% CI, 0.49 to 0.90; P=0.008). CONCLUSIONS: In patients with stable and unstable angina who underwent PCI after pretreatment with clopidogrel, bivalirudin did not provide a net clinical benefit (i.e., it did not reduce the incidence of the composite end point of death, myocardial infarction, urgent target-vessel revascularization, or major bleeding) as compared with unfractionated heparin, but it did significantly reduce the incidence of major bleeding. (ClinicalTrials.gov number, NCT00262054.)

Clinical outcome and predictors for adverse events after transcatheter aortic valve implantation with the use of different devices and access routes.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a treatment option for high-risk patients with severe aortic stenosis. Previous reports focused on a single device or access site, whereas little is known of the combined use of different devices and access sites as selected by the heart team. The purpose of this study is to investigate clinical outcomes of TAVI using different devices and access sites. METHODS: A consecutive cohort of 200 patients underwent TAVI with the Medtronic CoreValve Revalving system (Medtronic Core Valve LLC, Irvine, CA; n = 130) or the Edwards SAPIEN valve (Edwards Lifesciences LLC, Irvine, CA; n = 70) implanted by either the transfemoral or transapical access route. RESULTS: Device success and procedure success were 99% and 95%, respectively, without differences between devices and access site. All-cause mortality was 7.5% at 30 days, with no differences between valve types or access sites. Using multivariable analysis, low body mass index (<20 kg/m(2)) (odds ratio [OR] 6.6, 95% CI 1.5-29.5) and previous stroke (OR 4.4, 95% CI 1.2-16.8) were independent risk factors for short-term mortality. The VARC-defined combined safety end point occurred in 18% of patients and was driven by major access site complications (8.0%), life-threatening bleeding (8.5%) or severe renal failure (4.5%). Transapical access emerged as independent predictor of adverse outcome for the Valve Academic Research Consortium-combined safety end point (OR 3.3, 95% CI 1.5-7.1). CONCLUSION: A heart team-based selection of devices and access site among patients undergoing TAVI resulted in high device and procedural success. Low body mass index and history of previous stroke were independent predictors of mortality. Transapical access emerged as a risk factor for the Valve Academic Research Consortium-combined safety end point.

Dietary probiotics as a strategy for improving growth performance, intestinal efficacy, immunity, and antioxidant capacity of white Pekin ducks fed with different levels of CP.

The potential impacts of probiotics on the performance and health status of white Pekin ducks fed with optimal or suboptimal dietary CP were evaluated during the growing period. A total of 180 male white Pekin ducks (14-day-old ducks with an initial weight of 415.65 ± 2.20 g) were randomly divided into 4 experimental groups (45 in each group of 5 replicates) in a 2 × 2 factorial design. The main factors included 2 dietary CP levels (18 or 14%) and dietary probiotic addition (with or without probiotics). The probiotic source was supplemented at 0.2 g per kilogram of diet from a blend of Lactobacillus acidophilus and Lactobacillus casei. The results showed that the diet containing 18% CP and probiotics significantly increases the final and total weight gain. Activities of intestinal enzymes (amylase, lipase, and protease), morphometrics (villus length, goblet cell count, and cryptal depth), and carcass percentage were also increased significantly. Total protein content, lysozyme activity, bactericidal activity, nitro blue tetrazolium levels, alternative complement pathway, superoxide dismutase activity, and catalase activity were significantly increased, whereas glucose, cortisol, and total cholesterol levels were decreased when treated with diet containing 18% CP and probiotics. Conversely, the group treated with diet containing 14% CP without probiotics showed the poorest performance, carcass properties, immune response, and antioxidant potential. In conclusion, probiotic addition to the 14% CP diet improved the performance of white Pekin ducks caused by reduced CP diet to performance due to the 18% CP diet without probiotic supplementation.

Transcatheter Tricuspid Valve Intervention in Patients With Right Ventricular Dysfunction or Pulmonary Hypertension: Insights From the TriValve Registry.

BACKGROUND: Scarce data exist on patients with right ventricular dysfunction (RVD) or pulmonary hypertension (PH) undergoing transcatheter tricuspid valve intervention. This study aimed to determine the early and midterm outcomes and the factors associated with mortality in this group of patients. METHODS: This subanalysis of the multicenter TriValve (Transcatheter Tricuspid Valve Therapies) registry included 300 patients with severe tricuspid regurgitation with RVD (n=244), PH (n=127), or both (n=71) undergoing transcatheter tricuspid valve intervention. RVD was defined as a tricuspid annular plane systolic excursion <17 mm, and PH as an estimated pulmonary artery systolic pressure ≥50 mm Hg. RESULTS: Mean age of the patients was 77±9 years (54% women). Procedural success was 80.7%, and 9 patients (3%) died during the hospitalization. At a median follow-up of 6 (interquartile range, 2-12) months, 54 patients (18%) died, and the independent associated factors were higher gamma-glutamyl transferase values at baseline (hazard ratio, 1.02 for each increase of 10 u/L [95% CI, 1.002-1.04]), poorer renal function defined as an estimated glomerular filtration rate <45 mL/min (hazard ratio, 2.3 [95% CI, 1.22-4.33]), and the lack of procedural success (hazard ratio, 2.11 [95% CI, 1.17-3.81]). The grade of RVD and the amount of PH at baseline were not found to be predictors of mortality. Most patients alive at follow-up improved their functional class (New York Heart Association I-II in 66% versus 7% at baseline, P<0.001). CONCLUSIONS: In patients with severe tricuspid regurgitation and RVD/PH, transcatheter tricuspid valve intervention was associated with high procedural success and a relatively low in-hospital mortality, along with significant improvements in functional status. However, about 1 out of 5 patients died after a median follow-up of 6 months, with hepatic congestion, renal dysfunction, and the lack of procedural success determining an increased risk. These results may improve the clinical evaluation of transcatheter tricuspid valve intervention candidates and would suggest a closer follow-up in those at increased risk. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03416166.

Transcatheter Tricuspid Valve Intervention in Patients With Previous Left Valve Surgery.

BACKGROUND: Scarce data exist on patients with previous left valve surgery (PLVS) undergoing transcatheter tricuspid valve intervention (TTVI). This study sought to investigate the procedural and early outcomes in patients with PLVS undergoing TTVI. METHODS: This was a subanalysis of the multicenter TriValve registry including 462 patients, 82 (18%) with PLVS. Data were analyzed according to the presence of PLVS in the overall cohort and in a propensity score-matched population including 51 and 115 patients with and without PLVS, respectively. RESULTS: Patients with PLVS were younger (72 ± 10 vs 78 ± 9 years; p < 0.01) and more frequently female (67.1% vs 53.2%; P = 0.02). Similar rates of procedural success (PLVS 80.5%; no-PLVS 82.1%; P = 0.73), and 30-day mortality (PLVS 2.4%, no-PLVS 3.4%; P = 0.99) were observed. After matching, there were no significant differences in both all-cause rehospitalisation (PLVS 21.1%, no-PLVS 26.5%; P = 0.60) and all-cause mortality (PLVS 9.8%, no-PLVS 6.7%; P = 0.58). At last follow-up (median 6 [interquartile range 1-12] months after the procedure), most patients (81.8%) in the PLVS group were in NYHA functional class I-II (P = 0.12 vs no-PLVS group), and TR grade was ≤ 2 in 82.6% of patients (P = 0.096 vs no-PVLS group). A poorer right ventricular function and previous heart failure hospitalization determined increased risks of procedural failure and poorer outcomes at follow-up, respectively. CONCLUSIONS: In patients with PLVS, TTVI was associated with high rates of procedural success and low early mortality. However, about one-third of patients required rehospitalisation or died at midterm follow-up. These results would support TTVI as a reasonable alternative to redo surgery in patients with PLVS and suggest the importance of earlier treatment to improve clinical outcomes.