May 2025
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2 Reads
Journal of the Society for Cardiovascular Angiography & Interventions
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May 2025
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2 Reads
Journal of the Society for Cardiovascular Angiography & Interventions
May 2025
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8 Reads
Journal of the Society for Cardiovascular Angiography & Interventions
April 2025
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9 Reads
Journal of the American College of Cardiology
April 2025
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17 Reads
Journal of the American College of Cardiology
February 2025
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9 Reads
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1 Citation
JACC Cardiovascular Interventions
February 2025
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21 Reads
JACC Cardiovascular Interventions
February 2025
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4 Reads
JACC Cardiovascular Interventions
November 2024
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72 Reads
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4 Citations
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Background: There are limited head-to-head randomised trials comparing the performance of different transcatheter heart valves (THVs). Aims: We aimed to evaluate the non-inferiority of the balloon-expandable Myval THV series compared to the balloon-expandable SAPIEN THV series or the self-expanding Evolut THV series. Methods: The LANDMARK trial randomised 768 patients in a 1:1 ratio, (Myval THV series [n=384] vs contemporary series with 50% SAPIEN THV series [n=192] and 50% Evolut THV series [n=192]). The non-inferiority of Myval over the SAPIEN or Evolut THV series in terms of the 30-day primary composite safety and effectiveness endpoint as per the third Valve Academic Research Consortium (VARC-3) was tested in an intention-to-treat population with a predefined statistical power of 80% (1-sided alpha of 5%) for a non-inferiority margin of 10.44%. Results: The Myval THV series achieved non-inferiority for the primary composite endpoint over the SAPIEN THV series (24.7% vs 24.1%, risk difference [95% confidence interval {CI}]: 0.6% [not applicable {NA} to 8.0]; p=0.0033) and the Evolut THV series (24.7% vs 30.0%, risk difference [95% CI]: -5.3% [NA to 2.5]; p<0.0001). The incidences of pacemaker implantation were comparable (Myval THV series: 15.0%, SAPIEN THV series: 17.3%, Evolut THV series: 16.8%). At 30 days, the mean pressure gradient and effective orifice area were significantly better with the Myval THV series compared to the SAPIEN THV series (p<0.0001) and better with the Evolut THV series than with the Myval THV series (p<0.0001). At 30 days, the proportion of moderate to severe prosthetic valve regurgitation was numerically higher with the Evolut THV series compared to the Myval THV series (7.4% vs 3.4%; p=0.06), while not significantly different between the Myval THV series and the SAPIEN THV series (3.4% vs 1.6%; p=0.32). Conclusions: The Myval THV series is non-inferior to the SAPIEN THV series and the Evolut THV series in terms of the primary composite endpoint at 30 days. Clinical trial registration: ClinicalTrials.gov: NCT04275726; EudraCT number 2020-000,137-40.
October 2024
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60 Reads
The DynamX Bioadaptor is a novel implant with uncaging elements that disengage after polymer resorption and permits restoration of vessel function, thereby potentially reducing late adverse cardiac events. We evaluated the safety and efficacy of this novel implant with imaging follow-up at 6-months, the time point when the bioadaptor starts to uncage. This prospective study enrolled 44 patients with up to two de novo lesions at seven centers in New Zealand treated with the DynamX Bioadaptor. Follow-up was planned out to 12-months. The primary safety and efficacy endpoints were 6-month target lesion failure (TLF) and late lumen loss. Patients presented with non-ST elevation myocardial infarction in 49%. Lesions (n = 45) were 16.0 ± 6.7 mm long, and 2.81 ± 0.41 mm in diameter. Device and procedure success were 100%, and acute lumen gain was 1.93 ± 0.35 mm. At 6-months, median in-device late lumen loss was 0.09 mm (IQR:0.05–0.16). Measured by intravascular ultrasound, the vessel, lumen, and device area remained constant. By optical coherence tomography, 96.4% ± 5.9% of struts per lesion were covered. Out to 12-months, no TLF and no definite or probable device thrombosis were reported. In conclusion, this study provides evidence of the safety and performance of the DynamX Bioadaptor with excellent 12-month clinical and 6-month imaging outcomes comparable to best-in-class drug-eluting stents (DES). Trial Registration: ClinicalTrials.gov identifier: NCT03634020, NCT05464147, NCT04562805, and NCT04192747.
October 2024
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8 Reads
Journal of the American College of Cardiology
... Subsequently, 328 studies were assessed for full-text screening and eligibility, and 18 studies were included in our meta-analysis ( Figure 1). These studies, from 10 RCTs, comprised a total of 4325 patients undergoing TAVR (2295 BEV, 2030 SEV) [13,[15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31]. The complete characteristics of the included studies are available in Table 1 and Supporting Information S1: Table S4. ...
May 2024
The Lancet
... The ProtEmbo device uses a heparin-coated mesh to capture debris, while Emboliner is designed for full-body embolic protection, capturing debris from both the cerebral and peripheral circulation. Early studies with these devices have shown promising results in terms of debris capture, but their impact on stroke prevention remains to be fully determined [21,22]. ...
November 2023
The American Journal of Cardiology
... There is thus 'uncaging' despite the persistent presence of scaffolding metallic helical strands. There is now data from two large RCTs showing superior clinical outcomes compared to conventional DES, and even a possible plateau in device related adverse events from 6 months onward [11,12]. Should these benefits be confirmed over time, and across more complex patient and lesion subsets, the bioadaptor could offer a solution to flatten the event curve for patients treated with permanent metallic stent implants. ...
October 2023
EClinicalMedicine
... Endpoints have been described in detail previously. 14 The primary endpoint is TLF at 12 months, defined as Articles a composite of cardiovascular death, TV-MI and clinically-driven TLR. Secondary endpoints include lesion success (% diameter stenosis after treatment of target lesion with percutaneous coronary intervention, PCI, <30%), device success (% diameter stenosis after implantation of allocated study device <30%), and procedure success (lesion success without major adverse cardiac events during index hospitalisation). ...
May 2023
Cardiovascular Revascularization Medicine
... 8,25 While invasive diagnostic methods such as coronary angiography remain the gold standard, non-invasive diagnostic tools such as the models reviewed in this study have the potential to improve initial diagnosis in the emergency department and reduce unnecessary invasive procedures. 19 In addition, many models take into account comorbid conditions such as diabetes and psychiatric history, which are often associated with TTS. 1,24 This highlights the need for clinicians to take a holistic approach, assessing both mental and physical health to accurately assess risk. ...
April 2023
Heart, Lung and Circulation
... compared with the AMI group, the expression of TGF-β1, SMAD2, SMAD3 mRNA and protein in the rat of AMI+SIM-L, AMI+SIM-M and AMI+SIM-H groups significantly reduced (p>0.05) as shown in fig. 1 and Table 5. AMI is a very harmful disease to humans, which refers to the acute necrosis of part of the myocardium caused by long-lasting and severe myocardial ischemia, and in a short time, due to a certain reason, the human coronary artery has undergone occlusion, so that the human heart will be ischemic, causing a certain area of myocardial necrosis [8,9] . In this study, compared with the sham operation group, the LVW and LVWI of rats were significantly increased; SIM significantly reduced LVW and LVWI in rats compared with AMI group, compared with sham operation group, there were no significant changes in BW and lipid levels in rats of AMI group compared with those of sham operation group; compared with AMI group, SIM did not significantly affect the BW and lipid levels of rats. ...
March 2020
... Notably, in that study COPD patients were not analyzed separately, potentially explaining discrepant results as compared with ours. The increase in long-term mortality of TTS patients with COPD that we observed can be largely explained by the pulmonary disease-related outcomes [33], in line with the mainly non-cardiovascular mortality of TTS after the acute phase reported in multiple cohorts [5,34,35]. Notwithstanding, a very recent study described the presence of an excess of cardiovascular mortality too [36], with non-cardiovascular events attributed to pulmonary causes in most of the cases. Interestingly, in our population we observed the overall pharmacological undertreatment of COPD patients, who less often received a beta-blocker or a RAS inhibitor at discharge, similarly to what described in general heart failure patient populations [37,38]. ...
November 2021
Heart, Lung and Circulation
... In cases of complex multi-vessel disease, complete revascularisation with coronary artery bypass grafting (CABG) is recommended (43). Supplemental oxygen is recommended in MI if the patient's oxygen saturation is less than 90% (65,66). Beta-blockers may be administered to lower heart rate and reduce myocardial oxygen demand, thereby lowering the risk of arrhythmias and adverse cardiac events (67). ...
March 2021
The BMJ
... The LANDMARK trial demonstrated the non-inferiority of the Myval transcatheter heart valve (THV) series compared to contemporary standard THVs (Sapien and Evolut series) with respect to the composite of safety and effectiveness endpoint at 30 days in patients with symptomatic severe aortic stenosis. [1][2][3] The primary results at 30 days were published in The Lancet in May 2024. ...
January 2021
... Previous studies have reported that SC patients were predominantly women, especially postmenopausal women, and an associated stressor was identified in most patients. Emotional triggers were more common than physical triggers (4,(14)(15)(16)(17)(18). However, the InterTAK Registry has reported that physical stimuli (including fracture, infection, disorders in central nervous system, acute respiratory failure, and stress after operation) were more commonly seen compared to emotional stimuli (including interpersonal conflict, anger anxiety, panic, fear, and grief), at 36.0% vs. 27.7%, ...
August 2020
The New Zealand medical journal