| 1. |
- De Backer, Ole, et al.
(author)
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Efficacy and safety of the Lotus Valve System for treatment of patients with severe aortic valve stenosis and intermediate surgical risk: Results from the Nordic Lotus-TAVR registry
- 2016
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In: International Journal of Cardiology. - : Elsevier. - 0167-5273 .- 1874-1754. ; 219, s. 92-97
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Journal article (peer-reviewed)abstract
- Background: Transcatheter aortic valve replacement (TAVR) has becomean established therapeutic option for patients with symptomatic, severe aortic valve stenosis (AS) who are ineligible or at high risk for conventional valvular surgery. In Northwestern Europe, the TAVR technology is also increasingly used to treat patients with an intermediate risk profile. Methods and results: The study was designed as an independent Nordic multicenter registry of intermediate risk patients treated with the Lotus Valve System (Boston Scientific, MA, USA; N = 154). Valve Academic Research Consortium (VARC)-defined device success was obtained in 97.4%. A Lotus Valve was successfully implanted in all patients. There was no valve migration, embolization, ectopic valve deployment, or TAV-in-TAV deployment. The VARC-defined combined safety rate at 30 days was 92.2%, with a mortality rate of 1.9% and stroke rate of 3.2%. The clinical efficacy rate after 30 days was 91.6% - only one patient had moderate aortic regurgitation. When considering only those patients in the late experience group (N=79), the combined safety and clinical efficacy rates were 93.7% and 92.4%, respectively. The pacemaker implantation rate was 27.9% - this rate was 12.8% in case of a combined implantation depth amp;lt;4 mm and a device/annulus ratio amp;lt; 1.05. Conclusions: The present study demonstrates the efficacy and safety of the repositionable, retrievable Lotus Valve System in intermediate risk patients with AS. The VARC-defined device success rate was 97.4% with a 30-day patient safety and clinical efficacy rate of more than 90%. Less than moderate aortic regurgitation was obtained in 99.4% of patients. (C) 2016 Elsevier Ireland Ltd. All rights reserved.
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| 2. |
- Erlinge, David, et al.
(author)
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Rapid Endovascular Catheter Core Cooling Combined With Cold Saline as an Adjunct to Percutaneous Coronary Intervention for the Treatment of Acute Myocardial Infarction The CHILL-MI Trial : A Randomized Controlled Study of the Use of Central Venous Catheter Core Cooling Combined With Cold Saline as an Adjunct to Percutaneous Coronary Intervention for the Treatment of Acute Myocardial Infarction
- 2014
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In: Journal of the American College of Cardiology. - : Elsevier BV. - 0735-1097 .- 1558-3597. ; 63:18, s. 1857-1865
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Journal article (peer-reviewed)abstract
- Objectives The aim of this study was to confirm the cardioprotective effects of hypothermia using a combination of cold saline and endovascular cooling. Background Hypothermia has been reported to reduce infarct size (IS) in patients with ST-segment elevation myocardial infarctions. Methods In a multicenter study, 120 patients with ST-segment elevation myocardial infarctions (<6 h) scheduled to undergo percutaneous coronary intervention were randomized to hypothermia induced by the rapid infusion of 600 to 2,000 ml cold saline and endovascular cooling or standard of care. Hypothermia was initiated before percutaneous coronary intervention and continued for 1 h after reperfusion. The primary end point was IS as a percent of myocardium at risk (MaR), assessed by cardiac magnetic resonance imaging at 4 +/- 2 days. Results Mean times from symptom onset to randomization were 129 +/- 56 min in patients receiving hypothermia and 132 +/- 64 min in controls. Patients randomized to hypothermia achieved a core body temperature of 34.7 degrees C before reperfusion, with a 9-min longer door-to-balloon time. Median IS/MaR was not significantly reduced (hypothermia: 40.5% [interquartile range: 29.3% to 57.8%; control: 46.6% [interquartile range: 37.8% to 63.4%]; relative reduction 13%; p = 0.15). The incidence of heart failure was lower with hypothermia at 45 +/- 15 days (3% vs. 14%, p < 0.05), with no mortality. Exploratory analysis of early anterior infarctions (0 to 4 h) found a reduction in IS/MaR of 33% (p < 0.05) and an absolute reduction of IS/left ventricular volume of 6.2% (p = 0.15). Conclusions Hypothermia induced by cold saline and endovascular cooling was feasible and safe, and it rapidly reduced core temperature with minor reperfusion delay. The primary end point of IS/MaR was not significantly reduced. Lower incidence of heart failure and a possible effect in patients with early anterior ST-segment elevation myocardial infarctions need confirmation. (Efficacy of Endovascular Catheter Cooling Combined With Cold Saline for the Treatment of Acute Myocardial Infarction [CHILL-MI]; NCT01379261)
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| 3. |
- van der Pals, J., et al.
(author)
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Hypothermia in cardiogenic shock reduces systemic t-PA release
- 2011
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In: Journal of Thrombosis and Thrombolysis. - : Springer Science and Business Media LLC. - 0929-5305 .- 1573-742X. ; 32:1, s. 72-81
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Journal article (peer-reviewed)abstract
- Therapeutic hypothermia has been found to improve hemodynamic and metabolic parameters in cardiogenic shock. Tissue plasminogen activator (t-PA) is a pro-thrombolytic enzyme, which also possesses pro-inflammatory properties. Interleukin 6 (IL-6) and tumour necrosis factor alpha (TNF-alpha) are pro-inflammatory cytokines; interleukin 10 (IL-10) and transforming growth factor beta 1 (TGF-beta1) are anti-inflammatory cytokines. The aim of this experiment was to investigate the mechanism behind the protective effect of therapeutic hypothermia in cardiogenic shock. This was done by studying the effect of hypothermia on basal t-PA levels, peripheral t-PA release, and on the inflammatory response. Cardiogenic shock was induced by inflation of an angioplasty balloon in the proximal left anterior descending artery for 40 min in 16 pigs, followed by 110 min of reperfusion. The animals were randomized to hypothermia (33 degrees C, n = 8), or normothermia (n = 8) at reperfusion. Hemodynamic parameters were continuously monitored. Plasma was sampled every 30 min for analysis of blood-gases and t-PA, and for analysis of inflammatory markers at baseline and at the end of the experiment. t-PA, IL-6 and TGF-beta1 increased during cardiogenic shock. Apart from favourably affecting hemodynamic and metabolic variables, hypothermia was found to reduce basal arterial and venous t-PA levels, and to inhibit the release of t-PA from the peripheral vascular bed. Hypothermia did not alter the inflammatory response. In conclusion, mild hypothermia improves hemodynamic and metabolic parameters in cardiogenic shock. This is associated with a reduction in basal t-PA levels and t-PA release from the peripheral vascular bed, but not with an altered inflammatory response.
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| 4. |
- Wagner, Henrik, et al.
(author)
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Cerebral Oximetry During Prolonged Cardiac Arrest and Percutaneous Coronary Intervention : A Report on Five Cases
- 2013
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In: ICU Director. - : SAGE Publications. - 1944-4516 .- 1944-4524. ; 4:1, s. 22-32
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Journal article (other academic/artistic)abstract
- Objective. To evaluate the feasibility of cerebral oximetry (SctO2) with arterial blood pressure (ABP), central venous pressure (CVP), end tidal carbon dioxide (ETCO2), pulse oximetry (SpO2), and arterial blood gases during resuscitation in the coronary catheterization laboratory (cath-lab) setting. Design. We have implemented SctO2 in our cath-lab when cardiac arrest patients are in the need of prolonged resuscitation efforts with mechanical chest compressions (MCC) during simultaneous percutaneous coronary intervention (PCI). Setting. An academic coronary catheterization laboratory. Patients. Five cardiac arrest patients required prolonged resuscitation efforts with MCC in the cath-lab during simultaneous PCI. Results. During MCC, median SctO2 (n = 5) was 47%, median systolic ABP (n = 5) was 88 mm Hg, mean ABP (n = 5) was 58 mm Hg, coronary perfusion pressure (n = 3) was 19 mm Hg, SpO2 (n = 4) was 81%, and ETCO2 (n = 4) was 18.8 torr (2.5 kPa). Four patients had a successful PCI, including 1 patient with a pericardial drainage for cardiac tamponade during MCC. Mean treatment time of MCC in the cath-lab was 50.8 ± 28.3 minutes (median = 45 minutes, range = 12-90 minutes). Two patients obtained return of spontaneous circulation (ROSC). They died in the ICU due to impaired circulation and multiorgan failure, after 32 and 60 hours, respectively. Conclusion. Cerebral oximetry seems to be a feasible noninvasive parameter in assessing the perfusion and oxygenation of the brain in cardiac arrest patients receiving chest compressions during simultaneous PCI. Further studies are needed to evaluate its use in resuscitation situations to predict ROSC, quality of cardiopulmonary resuscitation, and neurologic outcome.
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