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CHICAGO – Starting transnasal evaporative cooling before patients in cardiac arrest arrive at the hospital has been found to be safe, according to study results presented at the American Heart Association scientific sessions.
The European trial didn’t determine any benefit in the out-of-hospital approach, compared with in-hospital cooling across all study patients. But it did suggest that patients with ventricular fibrillation may achieve higher rates of complete neurologic recovery with the prehospital cooling approach.
“Transnasal evaporative cooling in out-of-hospital cardiac arrest is hemodynamically safe,” said Per Nordberg, MD, PhD, of Karolinska Institute in Stockholm, reporting for the Prehospital Resuscitation Intra-arrest Cooling Effectiveness Survival Study (PRINCESS). “I think this an important message, because guidelines state at the moment that you shouldn’t cool patients outside the hospital. We have shown that this is possible with this new method.”
Transnasal evaporative cooling (RhinoChill) is a noninvasive method that involves cooling of the brain and provides continuous cooling without volume loading.
Centers in seven European countries participated in the trial, randomizing 677 patients to the transnasal, early cooling protocol or standard in-hospital hypothermia. The final analysis evaluated 671 patients: 337 in the intervention group and 334 in the control group. In the intervention group, the transnasal cooling technique was started on patients during CPR in their homes or in the ambulance.
The study found that the rate of 90-day survival with good neurological outcome was 16.6% in the intervention group, compared with 13.5% in the control group, a nonsignificant difference (P = .26).
“However, we could see a signal or a clinical trend toward an improved neurologic outcome in patients with ventricular fibrillation,” Dr. Nordberg said: 34.8% vs. 25.9% for the intervention vs. control populations, a relative, nonsignificant difference of 25% (P = .11).
In terms of complete neurologic recovery, the differences between the treatment groups among those with ventricular fibrillation were even more profound, and significant: 32.6% vs. 20% (P = .002).
Rates of cardiovascular complications – ventricular fibrillation, cardiogenic shock, pulmonary edema, and need for vasopressor – were similar between both groups, although the intervention group had low rates of nasal-related problems such as nose bleed and white nose tip that the control group didn’t have.
Transnasal evaporative cooling “could significantly shorten the time to the target temperature; we have shown that in previous safety feasibility trials,” Dr. Nordberg said. “Now, we can confirm that this method is effective to cool patients with cardiac arrest outside the hospital.”
In his discussion of the trial, Christopher B. Granger, MD, of Duke University, Durham, N.C., noted that the trial was well conducted and that it confirmed that patients can be rapidly cooled during or immediately after cardiac arrest. “But we still do not know if this has meaningful improvement in clinical outcomes,” he cautioned. A strength of the trial is its size, particularly “in a very challenging setting,” Dr. Granger added.
But he questioned the potential for neurological benefit in patients with ventricular fibrillation, particularly because the finding conflicts with a previously published trial (Crit Care Med. 2009 Dec;37[12]:3062-9). “With the primary outcome not significantly reduced, the subgroup analysis may not be reliable,” he said.
What’s needed next? “This trial provides some suggestion of the benefit of early rapid cooling in the ventricular fibrillation population,” Dr. Granger said, “but another trial is needed to justify a widespread change in practice.”
He reported receiving funding from the Swedish Heart-Lung Foundation. The makers of RhinoChill provided the cooling device used in the study at no cost to the participating sites.
Dr. Granger reported financial relationships with AbbVie, Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Daiichi Sankyo, Duke Clinical Research Institute, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Medtronic and the Medtronic Foundation, Merck, National Institutes of Health, Novartis, Pfizer, Rho Pharmaceuticals, Sirtex, and Verseon.
SOURCE: Nordberg P et al. Abstract 2018-LBCT-18598-AHA.
CHICAGO – Starting transnasal evaporative cooling before patients in cardiac arrest arrive at the hospital has been found to be safe, according to study results presented at the American Heart Association scientific sessions.
The European trial didn’t determine any benefit in the out-of-hospital approach, compared with in-hospital cooling across all study patients. But it did suggest that patients with ventricular fibrillation may achieve higher rates of complete neurologic recovery with the prehospital cooling approach.
“Transnasal evaporative cooling in out-of-hospital cardiac arrest is hemodynamically safe,” said Per Nordberg, MD, PhD, of Karolinska Institute in Stockholm, reporting for the Prehospital Resuscitation Intra-arrest Cooling Effectiveness Survival Study (PRINCESS). “I think this an important message, because guidelines state at the moment that you shouldn’t cool patients outside the hospital. We have shown that this is possible with this new method.”
Transnasal evaporative cooling (RhinoChill) is a noninvasive method that involves cooling of the brain and provides continuous cooling without volume loading.
Centers in seven European countries participated in the trial, randomizing 677 patients to the transnasal, early cooling protocol or standard in-hospital hypothermia. The final analysis evaluated 671 patients: 337 in the intervention group and 334 in the control group. In the intervention group, the transnasal cooling technique was started on patients during CPR in their homes or in the ambulance.
The study found that the rate of 90-day survival with good neurological outcome was 16.6% in the intervention group, compared with 13.5% in the control group, a nonsignificant difference (P = .26).
“However, we could see a signal or a clinical trend toward an improved neurologic outcome in patients with ventricular fibrillation,” Dr. Nordberg said: 34.8% vs. 25.9% for the intervention vs. control populations, a relative, nonsignificant difference of 25% (P = .11).
In terms of complete neurologic recovery, the differences between the treatment groups among those with ventricular fibrillation were even more profound, and significant: 32.6% vs. 20% (P = .002).
Rates of cardiovascular complications – ventricular fibrillation, cardiogenic shock, pulmonary edema, and need for vasopressor – were similar between both groups, although the intervention group had low rates of nasal-related problems such as nose bleed and white nose tip that the control group didn’t have.
Transnasal evaporative cooling “could significantly shorten the time to the target temperature; we have shown that in previous safety feasibility trials,” Dr. Nordberg said. “Now, we can confirm that this method is effective to cool patients with cardiac arrest outside the hospital.”
In his discussion of the trial, Christopher B. Granger, MD, of Duke University, Durham, N.C., noted that the trial was well conducted and that it confirmed that patients can be rapidly cooled during or immediately after cardiac arrest. “But we still do not know if this has meaningful improvement in clinical outcomes,” he cautioned. A strength of the trial is its size, particularly “in a very challenging setting,” Dr. Granger added.
But he questioned the potential for neurological benefit in patients with ventricular fibrillation, particularly because the finding conflicts with a previously published trial (Crit Care Med. 2009 Dec;37[12]:3062-9). “With the primary outcome not significantly reduced, the subgroup analysis may not be reliable,” he said.
What’s needed next? “This trial provides some suggestion of the benefit of early rapid cooling in the ventricular fibrillation population,” Dr. Granger said, “but another trial is needed to justify a widespread change in practice.”
He reported receiving funding from the Swedish Heart-Lung Foundation. The makers of RhinoChill provided the cooling device used in the study at no cost to the participating sites.
Dr. Granger reported financial relationships with AbbVie, Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Daiichi Sankyo, Duke Clinical Research Institute, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Medtronic and the Medtronic Foundation, Merck, National Institutes of Health, Novartis, Pfizer, Rho Pharmaceuticals, Sirtex, and Verseon.
SOURCE: Nordberg P et al. Abstract 2018-LBCT-18598-AHA.
CHICAGO – Starting transnasal evaporative cooling before patients in cardiac arrest arrive at the hospital has been found to be safe, according to study results presented at the American Heart Association scientific sessions.
The European trial didn’t determine any benefit in the out-of-hospital approach, compared with in-hospital cooling across all study patients. But it did suggest that patients with ventricular fibrillation may achieve higher rates of complete neurologic recovery with the prehospital cooling approach.
“Transnasal evaporative cooling in out-of-hospital cardiac arrest is hemodynamically safe,” said Per Nordberg, MD, PhD, of Karolinska Institute in Stockholm, reporting for the Prehospital Resuscitation Intra-arrest Cooling Effectiveness Survival Study (PRINCESS). “I think this an important message, because guidelines state at the moment that you shouldn’t cool patients outside the hospital. We have shown that this is possible with this new method.”
Transnasal evaporative cooling (RhinoChill) is a noninvasive method that involves cooling of the brain and provides continuous cooling without volume loading.
Centers in seven European countries participated in the trial, randomizing 677 patients to the transnasal, early cooling protocol or standard in-hospital hypothermia. The final analysis evaluated 671 patients: 337 in the intervention group and 334 in the control group. In the intervention group, the transnasal cooling technique was started on patients during CPR in their homes or in the ambulance.
The study found that the rate of 90-day survival with good neurological outcome was 16.6% in the intervention group, compared with 13.5% in the control group, a nonsignificant difference (P = .26).
“However, we could see a signal or a clinical trend toward an improved neurologic outcome in patients with ventricular fibrillation,” Dr. Nordberg said: 34.8% vs. 25.9% for the intervention vs. control populations, a relative, nonsignificant difference of 25% (P = .11).
In terms of complete neurologic recovery, the differences between the treatment groups among those with ventricular fibrillation were even more profound, and significant: 32.6% vs. 20% (P = .002).
Rates of cardiovascular complications – ventricular fibrillation, cardiogenic shock, pulmonary edema, and need for vasopressor – were similar between both groups, although the intervention group had low rates of nasal-related problems such as nose bleed and white nose tip that the control group didn’t have.
Transnasal evaporative cooling “could significantly shorten the time to the target temperature; we have shown that in previous safety feasibility trials,” Dr. Nordberg said. “Now, we can confirm that this method is effective to cool patients with cardiac arrest outside the hospital.”
In his discussion of the trial, Christopher B. Granger, MD, of Duke University, Durham, N.C., noted that the trial was well conducted and that it confirmed that patients can be rapidly cooled during or immediately after cardiac arrest. “But we still do not know if this has meaningful improvement in clinical outcomes,” he cautioned. A strength of the trial is its size, particularly “in a very challenging setting,” Dr. Granger added.
But he questioned the potential for neurological benefit in patients with ventricular fibrillation, particularly because the finding conflicts with a previously published trial (Crit Care Med. 2009 Dec;37[12]:3062-9). “With the primary outcome not significantly reduced, the subgroup analysis may not be reliable,” he said.
What’s needed next? “This trial provides some suggestion of the benefit of early rapid cooling in the ventricular fibrillation population,” Dr. Granger said, “but another trial is needed to justify a widespread change in practice.”
He reported receiving funding from the Swedish Heart-Lung Foundation. The makers of RhinoChill provided the cooling device used in the study at no cost to the participating sites.
Dr. Granger reported financial relationships with AbbVie, Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Daiichi Sankyo, Duke Clinical Research Institute, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Medtronic and the Medtronic Foundation, Merck, National Institutes of Health, Novartis, Pfizer, Rho Pharmaceuticals, Sirtex, and Verseon.
SOURCE: Nordberg P et al. Abstract 2018-LBCT-18598-AHA.
REPORTING FROM THE AHA SCIENTIFIC SESSIONS
Key clinical point: Prehospital hypothermia therapy for cardiac arrest patients is safe.
Major finding: Ninety-day survival was 16.6% in the intervention group vs. 13.5% in controls (P = .26).
Study details: A randomized clinical trial of 677 patients who had cardiac arrest outside the hospital.
Disclosures: Dr. Nordberg receives funding from the Swedish Heart-Lung Foundation. The makers of RhinoChill provided the cooling device used in the study at no cost to the participating sites.
Source: Nordberg P et al. Abstract 2018-LBCT-18598-AHA.