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- Noc, Marko, et al.
(författare)
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A multicentre, prospective, randomised controlled trial to assess the safety and effectiveness of cooling as an adjunctive therapy to percutaneous intervention in patients with acute myocardial infarction : The COOL AMI EU Pivotal Trial
- 2021
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Ingår i: EuroIntervention. - 1774-024X. ; 17:6, s. 466-473
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Tidskriftsartikel (refereegranskat)abstract
- Background: Despite primary PCI (PPCI), ST-elevation myocardial infarction (STEMI) can still result in large infarct size (IS). New technology with rapid intravascular cooling showed positive signals for reduction in IS in anterior STEMI. Aims: We investigated the effectiveness and safety of rapid systemic intravascular hypothermia as an adjunct to PPCI in conscious patients, with anterior STEMI, without cardiac arrest. Methods: Hypothermia was induced using the ZOLL® Proteus™ intravascular cooling system. After randomisation of 111 patients, 58 to hypothermia and 53 to control groups, the study was prematurely discontinued by the sponsor due to inconsistent patient logistics between the groups resulting in significantly longer total ischaemic delay in the hypothermia group (232 vs 188 minutes; p<0.001). Results: There were no differences in angiographic features and PPCI result between the groups. Intravascular temperature at wire crossing was 33.3+0.9°C. Infarct size/left ventricular (IS/LV) mass by cardiac magnetic resonance (CMR) at day 4-6 was 21.3% in the hypothermia group and 20.0% in the control group (p=0.540). Major adverse cardiac events at 30 days increased non-significantly in the hypothermia group (8.6% vs 1.9%; p=0.117) while cardiogenic shock (10.3% vs 0%; p=0.028) and paroxysmal atrial fibrillation (43.1% vs 3.8%; p<0.001) were significantly more frequent in the hypothermia group. Conclusions: The ZOLL Proteus intravascular cooling system reduced temperature to 33.3°C before PPCI in patients with anterior STEMI. Due to inconsistent patient logistics between the groups, this hypothermia protocol resulted in a longer ischaemic delay, did not reduce IS/LV mass and was associated with increased adverse events.
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| 2. |
- Noc, Marko, et al.
(författare)
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COOL AMI EU pilot trial : A multicentre, prospective, randomised controlled trial to assess cooling as an adjunctive therapy to percutaneous intervention in patients with acute myocardial infarction
- 2017
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Ingår i: EuroIntervention. - 1774-024X. ; 13:5, s. 531-539
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Tidskriftsartikel (refereegranskat)abstract
- Aims: We aimed to investigate the rapid induction of therapeutic hypothermia using the ZOLL Proteus Intravascular Temperature Management System in patients with anterior ST-elevation myocardial infarction (STEMI) without cardiac arrest. Methods and results: A total of 50 patients were randomised; 22 patients (88%; 95% confidence interval [CI]: 69-97%) in the hypothermia group and 23 patients (92%; 95% CI: 74-99) in the control group completed cardiac magnetic resonance imaging at four to six days and 30-day follow-up. Intravascular temperature at coronary guidewire crossing after 20.5 minutes of endovascular cooling decreased to 33.6°C (range 31.9-35.5°C). There was a 17-minute (95% CI: 4.6-29.8 min) cooling-related delay to reperfusion. In "per protocol" analysis, median infarct size/left ventricular mass was 16.7% in the hypothermia group versus 23.8% in the control group (absolute reduction 7.1%, relative reduction 30%; p=0.31) and median left ventricular ejection fraction (LVEF) was 42% in the hypothermia group and 40% in the control group (absolute reduction 2.4%, relative reduction 6%; p=0.36). Except for self-terminating paroxysmal atrial fibrillation (32% versus 8%; p=0.074), there was no excess of adverse events in the hypothermia group. Conclusions: We rapidly and safely cooled patients with anterior STEMI to 33.6°C at the time of coronary guidewire crossing. This is ≥1.1°C lower than in previous cooling studies. Except for self-terminating atrial fibrillation, there was no excess of adverse events and no clinically important cooling-related delay to reperfusion. A statistically non-significant numerical 7.1% absolute and 30% relative reduction in infarct size warrants a pivotal trial powered for efficacy.
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| 3. |
- Végh, Eszter M, et al.
(författare)
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A new simplified electrocardiographic score predicts clinical outcome in patients treated with CRT
- 2018
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Ingår i: Europace. - : Oxford University Press (OUP). - 1532-2092. ; 20:3, s. 492-500
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Tidskriftsartikel (refereegranskat)abstract
- Aims Cardiac Resynchronization Therapy (CRT) reduces morbidity and mortality for patients with heart failure and wide QRS complex, but up to 1/3 of patients are "non-responders" to the therapy. This study examines the ability of a simple standard electrocardiogram (ECG)-based scoring system to predict clinical outcome. Methods and results Four hundred and ninety-one consecutive patients with CRT-implants (79% males, mean age 71 years, LVEF 24%, 59% with ischemic cardiomyopathy, 83% in NYHA class III) were included from a single large volume centre. All patients met standard indications for CRT, and were followed for 3 years after CRT implantation. Three ECG parameters were measured on the post-implant ECG, and compared to pre-implantation measurements: QRS duration, time to intrinsicoid deflection onset (ID) in V1 lead, amplitude change in V1 lead. Each positive ECG variable was given a numerical value of 1 to create the score (ranging 0–3). Clinical outcome was assessed as a composite of all-cause death, left ventricular assist device implantation, cardiac transplantation and HF hospitalization. Event-free survival was predicted by shortening of QRS duration ≥20 ms (HR 0.66 [95% CI 0.48–0.90] P = 0.009), ≥50% decreased summed R + S amplitude in V1 lead (HR 0.67 [0.49–0.90] P = 0.009) and ≤40 msec ID time in lead V1 during pacing (HR 0.63 [0.46–0.86] P = 0.004). The total score was an independent predictor for both event-free survival (HR 0.65 [0.54–0.77] P < 0.001) and for ≥10% left ventricular ejection fraction improvement (OR 1.7 [1.3–2.3] P < 0.001). Conclusions Composite data from 12-lead ECG during CRT-treatment can be used in a simple score to predict long-term clinical outcome.
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