| 1. |
- El Farissi, Mohamed, et al.
(author)
-
A randomised trial of selective intracoronary hypothermia during primary PCI
- 2024
-
In: EuroIntervention. - : European Society of Cardiology. - 1774-024X .- 1969-6213. ; 20:12
-
Journal article (peer-reviewed)abstract
- BACKGROUND: While experimental data suggest that selective intracoronary hypothermia decreases infarct size, studies in patients with ST-elevation myocardial infarction (STEMI) are lacking.AIMS: We investigated the efficacy of selective intracoronary hypothermia during primary percutaneous coronary intervention (PCI) to decrease infarct size in patients with STEMI.METHODS: In this multicentre randomised controlled trial, 200 patients with large anterior wall STEMI were randomised 1:1 to selective intracoronary hypothermia during primary PCI or primary PCI alone. Using an over-the-wire balloon catheter for infusion of cold saline and a pressure-temperature wire to monitor the intracoronary temperature, the anterior myocardium distal to the occlusion was selectively cooled to 30-33°C for 7-10 minutes before reperfusion (occlusion phase), immediately followed by 10 minutes of cooling after reperfusion (reperfusion phase). The primary endpoint was infarct size as a percentage of left ventricular mass on cardiovascular magnetic resonance imaging after 3 months.RESULTS: Selective intracoronary hypothermia was performed in 94/100 patients randomised to cooling. Distal coronary temperature decreased by 6°C within 43 seconds (interquartile range [IQR] 18-113). The median duration of the occlusion phase and reperfusion phase were 8.2 minutes (IQR 7.2-9.0) and 9.1 minutes (IQR 8.2-10.0), respectively. The infarct size at 3 months was 23.1±12.5% in the selective intracoronary hypothermia group and 21.6±12.2% in the primary PCI alone group (p=0.43). The left ventricular ejection fraction at 3 months in each group were 49.1±10.2% and 50.1±10.4%, respectively (p=0.53).CONCLUSIONS: Selective intracoronary hypothermia during primary PCI in patients with anterior wall STEMI was feasible and safe but did not decrease infarct size compared with standard primary PCI. (ClinicalTrials.gov: NCT03447834).
|
|
| 2. |
- El Farissi, Mohamed, et al.
(author)
-
Safety of Selective Intracoronary Hypothermia During Primary Percutaneous Coronary Intervention in Patients With Anterior STEMI
- 2021
-
In: JACC. - : Elsevier. - 1936-8798 .- 1876-7605. ; 14:18, s. 2047-2055
-
Journal article (peer-reviewed)abstract
- OBJECTIVES: The aim of this study was to determine the safety of selective intracoronary hypothermia during primary percutaneous coronary intervention (PPCI) in patients with anterior ST-segment elevation myocardial infarction (STEMI).BACKGROUND: Selective intracoronary hypothermia is a novel treatment designed to reduce myocardial reperfusion injury and is currently being investigated in the ongoing randomized controlled EURO-ICE (European Intracoronary Cooling Evaluation in Patients With ST-Elevation Myocardial Infarction) trial (NCT03447834). Data on the safety of such a procedure during PPCI are still limited.METHODS: The first 50 patients with anterior STEMI treated with selective intracoronary hypothermia during PPCI were included in this analysis and compared for safety with the first 50 patients randomized to the control group undergoing standard PPCI. In-hospital mortality, occurrence of rhythm or conduction disturbances, stent thrombosis, onset of heart failure during the procedure, and subsequent hospital admission were assessed.RESULTS: In-hospital mortality was 0%. One patient in both groups developed cardiogenic shock. Atrial fibrillation occurred in 0 and 3 patients (P = 0.24), and ventricular fibrillation occurred in 5 and 3 patients (P = 0.72) in the intracoronary hypothermia group and control group, respectively. Stent thrombosis occurred in 2 patients in the intracoronary hypothermia group; 1 instance was intraprocedural, and the other occurred following interruption of dual-antiplatelet therapy consequent to an intracranial hemorrhage 6 days after enrollment. No stent thrombosis was observed in the control group (P = 0.50).CONCLUSIONS: Selective intracoronary hypothermia during PPCI in patients with anterior STEMI can be implemented within the routine of PPCI and seems to be safe. The final safety results will be reported at the end of the trial.
|
|
| 3. |
- Keeble, Thomas R., et al.
(author)
-
Effect of intravascular cooling on microvascular obstruction (MVO) in conscious patients with ST-elevation myocardial infarction undergoing primary PCI : Results from the COOL AMI EU pilot study
- 2019
-
In: Cardiovascular Revascularization Medicine. - : Elsevier BV. - 1553-8389. ; 20:9, s. 799-804
-
Journal article (peer-reviewed)abstract
- Objective: COOL AMI EU pilot was a multi-center, randomized controlled trial to assess feasibility and safety of rapid intravascular therapeutic hypothermia (TH) in conscious patients with anterior ST-elevation myocardial infarction (STEMI) undergoing primary PCI (PPCI). We report the effect of hypothermia upon microvascular obstruction (MVO). Methods: Conscious patients with anterior STEMI and symptom duration <6 h were recruited and randomized to PPCI + TH or PPCI alone. TH was induced using the ZOLL® Proteus™ intravascular temperature management system and rapid infusion of 1 L of cold normal saline, with a target temperature of 32 °C. MVO was measured by cardiac magnetic resonance (CMR) at 4 to 6 days post-MI. MVO larger than 3.9% of LV was considered as extensive MVO. Results: 50 patients were randomized; mean age was 58 years, and 86% were men. At reperfusion, mean intravascular temperature for the TH group was 33.6 ± 1 °C. The presence of MVO was high and not different in both groups (74% vs. 77%, p = 0.79). The proportion of patients with extensive MVO was 11% in the TH group and 23% in the control group (OR 0.4 95%CI 0.07–2.35, p = 0.30). Patients with extensive MVO showed reduced EF at 4–6 days (34% versus 43%, p = 0.01). The percentage of patients with EF <35% at 30 days was 6% in the TH group versus 24% in the control group (p = 0.19). Conclusion: In the COOL-AMI Pilot Trial, the presence of MVO in both test groups was high and extensive MVO was related with reduced LVEF. The efficacy of therapeutic hypothermia (TH) in MVO reduction should be tested in a pivotal trial.
|
|
| 4. |
- Mion, Marco, et al.
(author)
-
Follow-up care after out-of-hospital cardiac arrest: A pilot study of survivors and families’ experiences and recommendations
- 2021
-
In: Resuscitation Plus. - : Elsevier BV. - 2666-5204. ; 7
-
Journal article (peer-reviewed)abstract
- Background and objectives Cognitive and physical difficulties are common in survivors of out-of-hospital cardiac arrest (OHCA); both survivors and close family members are also at risk of developing mood disorders. In the UK, dedicated follow-up pathways for OHCA survivors and their family are lacking. A cohort of survivors and family members were surveyed regarding their experience of post-discharge care and their recommended improvements. Method 123 OHCA survivors and 39 family members completed questionnaires during an educational event or later online. Questions addressed both the actual follow-up offered and the perceived requirements for optimal follow-up from the patient and family perspective, including consideration of timing, professionals involved, involvement of family members and areas they felt should be covered. Results Outpatient follow-up was commonly arranged after OHCA (77%). This was most often conducted by a cardiologist alone (80%) but survivors suggested that other professionals should also be involved (e.g. psychologist/counsellor, 64%). Topics recommended for consideration included cardiac arrest-related issues (heart disease; cause of arrest) mental fatigue/sleep disturbance, cognitive problems, emotional problems and daily activities. Most survivors advocated an early review (<1month; 61%). Most family members reported some psychological difficulties (95%); many of them (95%) advocated a dedicated follow-up appointment for family members of survivors. Conclusions The majority of OHCA survivors advocated an early follow-up following hospital discharge and a holistic, multidimensional assessment of arrest sequelae. These results suggest that current OHCA follow-up often fails to address patient-centred issues and to provide access to professionals deemed important by survivors and family members.
|
|
| 5. |
|
|
| 6. |
- Simpson, Rupert F.G., et al.
(author)
-
Speed of cooling after cardiac arrest in relation to the intervention effect : a sub-study from the TTM2-trial
- 2022
-
In: Critical Care. - : Springer Science and Business Media LLC. - 1364-8535 .- 1466-609X. ; 26:1
-
Journal article (peer-reviewed)abstract
- Background: Targeted temperature management (TTM) is recommended following cardiac arrest; however, time to target temperature varies in clinical practice. We hypothesised the effects of a target temperature of 33 °C when compared to normothermia would differ based on average time to hypothermia and those patients achieving hypothermia fastest would have more favorable outcomes. Methods: In this post-hoc analysis of the TTM-2 trial, patients after out of hospital cardiac arrest were randomized to targeted hypothermia (33 °C), followed by controlled re-warming, or normothermia with early treatment of fever (body temperature, ≥ 37.8 °C). The average temperature at 4 h (240 min) after return of spontaneous circulation (ROSC) was calculated for participating sites. Primary outcome was death from any cause at 6 months. Secondary outcome was poor functional outcome at 6 months (score of 4–6 on modified Rankin scale). Results: A total of 1592 participants were evaluated for the primary outcome. We found no evidence of heterogeneity of intervention effect based on the average time to target temperature on mortality (p = 0.17). Of patients allocated to hypothermia at the fastest sites, 71 of 145 (49%) had died compared to 68 of 148 (46%) of the normothermia group (relative risk with hypothermia, 1.07; 95% confidence interval 0.84–1.36). Poor functional outcome was reported in 74/144 (51%) patients in the hypothermia group, and 75/147 (51%) patients in the normothermia group (relative risk with hypothermia 1.01 (95% CI 0.80–1.26). Conclusions: Using a hospital’s average time to hypothermia did not significantly alter the effect of TTM of 33 °C compared to normothermia and early treatment of fever.
|
|
