Per-Protocol and Pre-Defined population analysis of the LINC study.

OBJECTIVE: To perform two predefined sub-group analyses within the LINC study and evaluate if the results were supportive of the previous reported intention to treat (ITT) analysis. METHODS: Predefined subgroup analyses from the previously published LINC study were performed. The Per-Protocol population (PPP) included the randomized patients included in the ITT-population but excluding those with violated inclusion or exclusion criteria and those that did not get the actual treatment to which the patient was randomized. In the Pre-Defined population (PDP) analyses patients were also excluded if the dispatch time to ambulance arrival at the address exceeded 12 min, there was a non-witnessed cardiac arrest, or if it was not possible to determine whether the arrest was witnessed or not, and those cases where LUCAS was not brought to the scene at the first instance. RESULTS: After exclusion from the 2589 patients within the ITT-population, the Per-Protocol analysis was performed in 2370 patients and the Pre-Defined analysis within 1133 patients. There was no significant difference in 4-h survival of patients between the mechanical-CPR group and the manual-CPR group in the Per-Protocol population; 279 of 1172 patients (23.8%) versus 281 of 1198 patients (23.5%) (risk difference -0.35%, 95% C.I. -3.1 to 3.8, p=0.85) or in the Pre-Defined population; 176 of 567 patients (31.0%) versus 192 of 566 patients (33.9%) (risk difference -2.88%, 95% C.I. -8.3 to 2.6, p=0.31). There was no difference in any of the second outcome variables analyzed in the Pre-Protocol or Pre-Defined populations. CONCLUSIONS: The results from these predefined sub-group analyses of the LINC study population did not show any difference in 4h survival or in secondary outcome variables between patients treated with mechanical-CPR or manual-CPR. This is consistent with the previously published ITT analysis.

Mechanical chest compressions and simultaneous defibrillation vs conventional cardiopulmonary resuscitation in out-of-hospital cardiac arrest: the LINC randomized trial.

IMPORTANCE: A strategy using mechanical chest compressions might improve the poor outcome in out-of-hospital cardiac arrest, but such a strategy has not been tested in large clinical trials. OBJECTIVE: To determine whether administering mechanical chest compressions with defibrillation during ongoing compressions (mechanical CPR), compared with manual cardiopulmonary resuscitation (manual CPR), according to guidelines, would improve 4-hour survival. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized clinical trial of 2589 patients with out-of-hospital cardiac arrest conducted between January 2008 and February 2013 in 4 Swedish, 1 British, and 1 Dutch ambulance services and their referring hospitals. Duration of follow-up was 6 months. INTERVENTIONS: Patients were randomized to receive either mechanical chest compressions (LUCAS Chest Compression System, Physio-Control/Jolife AB) combined with defibrillation during ongoing compressions (n = 1300) or to manual CPR according to guidelines (n = 1289). MAIN OUTCOMES AND MEASURES: Four-hour survival, with secondary end points of survival up to 6 months with good neurological outcome using the Cerebral Performance Category (CPC) score. A CPC score of 1 or 2 was classified as a good outcome. RESULTS: Four-hour survival was achieved in 307 patients (23.6%) with mechanical CPR and 305 (23.7%) with manual CPR (risk difference, -0.05%; 95% CI, -3.3% to 3.2%; P > .99). Survival with a CPC score of 1 or 2 occurred in 98 (7.5%) vs 82 (6.4%) (risk difference, 1.18%; 95% CI, -0.78% to 3.1%) at intensive care unit discharge, in 108 (8.3%) vs 100 (7.8%) (risk difference, 0.55%; 95% CI, -1.5% to 2.6%) at hospital discharge, in 105 (8.1%) vs 94 (7.3%) (risk difference, 0.78%; 95% CI, -1.3% to 2.8%) at 1 month, and in 110 (8.5%) vs 98 (7.6%) (risk difference, 0.86%; 95% CI, -1.2% to 3.0%) at 6 months with mechanical CPR and manual CPR, respectively. Among patients surviving at 6 months, 99% in the mechanical CPR group and 94% in the manual CPR group had CPC scores of 1 or 2. CONCLUSIONS AND RELEVANCE: Among adults with out-of-hospital cardiac arrest, there was no significant difference in 4-hour survival between patients treated with the mechanical CPR algorithm or those treated with guideline-adherent manual CPR. The vast majority of survivors in both groups had good neurological outcomes by 6 months. In clinical practice, mechanical CPR using the presented algorithm did not result in improved effectiveness compared with manual CPR. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00609778.

The study protocol for the LINC (LUCAS in cardiac arrest) study: a study comparing conventional adult out-of-hospital cardiopulmonary resuscitation with a concept with mechanical chest compressions and simultaneous defibrillation.

BACKGROUND: The LUCAS™ device delivers mechanical chest compressions that have been shown in experimental studies to improve perfusion pressures to the brain and heart as well as augmenting cerebral blood flow and end tidal CO2, compared with results from standard manual cardiopulmonary resuscitation (CPR). Two randomised pilot studies in out-of-hospital cardiac arrest patients have not shown improved outcome when compared with manual CPR. There remains evidence from small case series that the device can be potentially beneficial compared with manual chest compressions in specific situations. This multicentre study is designed to evaluate the efficacy and safety of mechanical chest compressions with the LUCAS™ device whilst allowing defibrillation during on-going CPR, and comparing the results with those of conventional resuscitation. METHODS/DESIGN: This article describes the design and protocol of the LINC-study which is a randomised controlled multicentre study of 2500 out-of-hospital cardiac arrest patients. The study has been registered at ClinicalTrials.gov (http://clinicaltrials.gov/ct2/show/NCT00609778?term=LINC&rank=1). RESULTS: Primary endpoint is four-hour survival after successful restoration of spontaneous circulation. The safety aspect is being evaluated by post mortem examinations in 300 patients that may reflect injuries from CPR. CONCLUSION: This large multicentre study will contribute to the evaluation of mechanical chest compression in CPR and specifically to the efficacy and safety of the LUCAS™ device when used in association with defibrillation during on-going CPR.

Increase in survival and bystander CPR in out-of-hospital shockable arrhythmia: bystander CPR and female gender are predictors of improved outcome. Experiences from Sweden in an 18-year perspective.

OBJECTIVES: In a national perspective, to describe survival among patients found in ventricular fibrillation or pulseless ventricular tachycardia witnessed by a bystander and with a presumed cardiac aetiology and answer two principal questions: (1) what are the changes over time? and (2) which are the factors of importance? DESIGN: Observational register study. SETTING: Sweden. PATIENTS: All patients included in the Swedish Out of Hospital Cardiac Arrest Register between 1 January 1990 and 31 December 2009 who were found in bystander-witnessed ventricular fibrillation with a presumed cardiac aetiology. Interventions Bystander cardiopulmonary resuscitation (CPR) and defibrillation. MAIN OUTCOME MEASURES: Survival to 1 month. RESULTS: In all, 7187 patients fulfilled the set criteria. Age, place of out-of-hospital cardiac arrest (OHCA) and gender did not change. Bystander CPR increased from 46% to 73%; 95% CI for OR 1.060 to 1.081 per year. The median delay from collapse to defibrillation increased from 12 min to 14 min (p for trend 0.0004). Early survival increased from 28% to 45% (95% CI 1.044 to 1.065) and survival to 1 month increased from 12% to 23% (95% CI 1.058 to 1.086). Strong predictors of early and late survival were a short interval from collapse to defibrillation, bystander CPR, female gender and OHCA outside the home. CONCLUSION: In a long-term perspective in Sweden, survival to 1 month after ventricular fibrillation almost doubled. This was associated with a marked increase in bystander CPR. Strong predictors of outcome were a short delay to defibrillation, bystander CPR, female gender and place of collapse.

Characteristics and outcome among patients suffering out-of-hospital cardiac arrest due to drowning.

AIM: To describe the characteristics and outcome among patients with out-of-hospital cardiac arrest (OHCA) caused by drowning as compared with OHCA caused by a cardiac etiology (outside home). PATIENTS AND METHODS: All the patients included in the Swedish OHCA Registry between 1990 and 2005 which were not crew witnessed, in whom cardio-pulmonary resuscitation (CPR) was attempted, were evaluated for inclusion. Those caused by drowning were compared with those with a cardiac etiology (outside home). RESULTS: Patients with OHCA due to drowning (n=255) differed from patients with OHCA with a cardiac etiology (n=7494) as they were younger, less frequently suffered a witnessed OHCA, more frequently received bystander CPR and less frequently were found in a shockable rhythm. Patients with OHCA due to drowning had a prolonged ambulance response time as compared with patients with OHCA with a cardiac etiology. Patients with OHCA due to drowning had a survival rate to 1 month of 11.5% as compared with 8.8% among patients with OHCA due to a cardiac etiology (NS). Among patients with OHCA due to drowning, only one independent predictor of survival was defined, i.e. time from calling for an ambulance until the arrival of the rescue team, with a much higher survival among patients with a shorter ambulance response time. CONCLUSION: Among patients with OHCA 0.9% were caused by drowning. They had a similar survival rate to 1 month as compared with OHCA outside home with a cardiac etiology. The factor associated with survival was the ambulance response time; a higher survival with a shorter response time.

Characteristics of cardiac arrest and resuscitation by age group: an analysis from the Swedish Cardiac Arrest Registry.

AIM: The objective of this study was to describe patients who experienced an out-of-hospital cardiac arrest (OHCA) by age group. METHODS: All patients who suffered from an OHCA between 1990 and 2005 and are included in the Swedish Cardiac Arrest Registry (n = 40,503) were classified into the following age groups: neonates, younger than 1 year; young children, between 1 and 4 years; older children, between 5 and 12 years; adolescents, between 13 and 17 years; young adults, between 18 and 35 years; adults not retired, between 36 and 64 years; adults retired, between 65 and 79 years; and older adults, 80 years or older. RESULTS: Ventricular fibrillation was lowest in young children (3%) and highest in adults (35%). Survival to 1 month was lowest in neonates (2.6%) and highest in older children (7.8%). Children (<18 years), young adults (18-35 years), and adults (>35 years) survived to 1 month 24.5%, 21.2%, and 13.6% of cases, respectively (P = .0003 for trend) when found in a shockable rhythm. The corresponding figures for nonshockable rhythms were 3.8%, 3.2%, and 1.6%, respectively (P < .0001 for trend). CONCLUSIONS: There is a large variability in characteristics and outcome among patients in various age groups who experienced an OHCA. Among the large age groups, there was a successive decline in survival with increasing age in shockable and nonshockable rhythms.