[Recommendations of the S3 Guideline "Use of Extracorporeal Circulation (ECLS/ ECMO) for Cardiac and Circulatory Failure" of the Association of Scientific Medical Societies in Germany]. / Empfehlungen der S3-Leitlinie (AWMF) "Einsatz der extrakorporalen Zirkulation (ECLS/ECMO) bei Herz- und Kreislaufversagen".

In recent years, the use of mechanical support for patients with cardiac or circulatory failure has continuously increased, leading to 3,000 ECLS/ECMO (extracorporeal life support/extracorporeal membrane oxygenation) implantations annually in Germany. Due to the lack of guidelines, there is an urgent need for evidence-based recommendations addressing the central aspects of ECLS/ECMO therapy. In July 2015, the generation of a guideline level S3 according to the standards of the Association of the Scientific Medical Societies in Germany (AWMF) was announced by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS). In a well-structured consensus process, involving experts from Germany, Austria and Switzerland, delegated by 16 scientific societies and the patients' representation, the guideline "Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure" was created under guidance of the GSTCVS, and published in February 2021. The guideline focuses on clinical aspects of initiation, continuation, weaning and aftercare, herein also addressing structural and economic issues. This article presents an overview on the methodology as well as the final recommendations.

Key characteristics impacting survival of COVID-19 extracorporeal membrane oxygenation.

BACKGROUND: Severe COVID-19 induced acute respiratory distress syndrome (ARDS) often requires extracorporeal membrane oxygenation (ECMO). Recent German health insurance data revealed low ICU survival rates. Patient characteristics and experience of the ECMO center may determine intensive care unit (ICU) survival. The current study aimed to identify factors affecting ICU survival of COVID-19 ECMO patients. METHODS: 673 COVID-19 ARDS ECMO patients treated in 26 centers between January 1st 2020 and March 22nd 2021 were included. Data on clinical characteristics, adjunct therapies, complications, and outcome were documented. Block wise logistic regression analysis was applied to identify variables associated with ICU-survival. RESULTS: Most patients were between 50 and 70 years of age. PaO2/FiO2 ratio prior to ECMO was 72 mmHg (IQR: 58-99). ICU survival was 31.4%. Survival was significantly lower during the 2nd wave of the COVID-19 pandemic. A subgroup of 284 (42%) patients fulfilling modified EOLIA criteria had a higher survival (38%) (p = 0.0014, OR 0.64 (CI 0.41-0.99)). Survival differed between low, intermediate, and high-volume centers with 20%, 30%, and 38%, respectively (p = 0.0024). Treatment in high volume centers resulted in an odds ratio of 0.55 (CI 0.28-1.02) compared to low volume centers. Additional factors associated with survival were younger age, shorter time between intubation and ECMO initiation, BMI > 35 (compared to < 25), absence of renal replacement therapy or major bleeding/thromboembolic events. CONCLUSIONS: Structural and patient-related factors, including age, comorbidities and ECMO case volume, determined the survival of COVID-19 ECMO. These factors combined with a more liberal ECMO indication during the 2nd wave may explain the reasonably overall low survival rate. Careful selection of patients and treatment in high volume ECMO centers was associated with higher odds of ICU survival. TRIAL REGISTRATION: Registered in the German Clinical Trials Register (study ID: DRKS00022964, retrospectively registered, September 7th 2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00022964 .

Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure -A clinical practice Guideline Level 3.

Aims Worldwide applications of extracorporeal circulation for mechanical support in cardiac and circulatory failure, which are referred to as extracorporeal life support (ECLS) or veno-arterial extracorporeal membrane oxygenation (va-ECMO), have dramatically increased over the past decade. In spite of the expanding use and the immense medical as well as socio-economic impact of this therapeutic approach, there has been a lack of interdisciplinary recommendations considering the best available evidence for ECLS treatment. Methods and Results In a multiprofessional, interdisciplinary scientific effort of all scientific societies involved in the treatment of patients with acute cardiac and circulatory failure, the first evidence- and expert consensus-based guideline (level S3) on ECLS/ECMO therapy was developed in a structured approach under regulations of the AWMF (Association of the Scientific Medical Societies in Germany) and under use of GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria. This article presents all recommendations created by the expert panel, addressing a multitude of aspects for ECLS initiation, continuation, weaning and aftercare as well as structural and personnel requirements. Conclusions This first evidence- and expert consensus-based guideline (level S3) on ECLS/ECMO therapy should be used to apply the best available care nationwide. Beyond clinical practice advice, remaining important research aspects for future scientific efforts are formulated.

[Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure : Short version of the S3 guideline]. / Einsatz der extrakorporalen Zirkulation (ECLS/ECMO) bei Herz- und Kreislaufversagen : Kurzversion der AWMF-S3-Leitlinie.

In Germany, a remarkable increase regarding the usage of extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) systems has been observed in recent years with approximately 3000 ECLS/ECMO implantations annually since 2015. Despite the widespread use of ECLS/ECMO, evidence-based recommendations or guidelines are still lacking regarding indications, contraindications, limitations and management of ECMO/ECLS patients. Therefore in 2015, the German Society of Thoracic and Cardiovascular Surgery (GSTCVS) registered the multidisciplinary S3 guideline "Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure" to develop evidence-based recommendations for ECMO/ECLS systems according to the requirements of the Association of the Scientific Medical Societies in Germany (AWMF). Although the clinical application of ECMO/ECLS represents the main focus, the presented guideline also addresses structural and economic issues. Experts from 17 German, Austrian and Swiss scientific societies and a patients' organization, guided by the GSTCVS, completed the project in February 2021. In this report, we present a summary of the methodological concept and tables displaying the recommendations for each chapter of the guideline.

[Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure : Short version of the S3 guideline]. / Einsatz der extrakorporalen Zirkulation (ECLS/ECMO) bei Herz- und Kreislaufversagen : Kurzversion der AWMF-S3-Leitlinie.

In Germany, a remarkable increase regarding the usage of extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) systems has been observed in recent years with approximately 3000 ECLS/ECMO implantations annually since 2015. Despite the widespread use of ECLS/ECMO, evidence-based recommendations or guidelines are still lacking regarding indications, contraindications, limitations and management of ECMO/ECLS patients. Therefore in 2015, the German Society of Thoracic and Cardiovascular Surgery (GSTCVS) registered the multidisciplinary S3 guideline "Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure" to develop evidence-based recommendations for ECMO/ECLS systems according to the requirements of the Association of the Scientific Medical Societies in Germany (AWMF). Although the clinical application of ECMO/ECLS represents the main focus, the presented guideline also addresses structural and economic issues. Experts from 17 German, Austrian and Swiss scientific societies and a patients' organization, guided by the GSTCVS, completed the project in February 2021. In this report, we present a summary of the methodological concept and tables displaying the recommendations for each chapter of the guideline.

[Recommendations for emergency management of patients with permanent mechanical circulatory support : Consensus statement of DGTHG, DIVI, DGIIN, DGAI, DGINA, DGfK and DGK]. / Empfehlungen zum Notfallmanagement von Patienten mit permanenten Herzunterstützungssystemen : Konsensuspapier der DGTHG, DIVI, DGIIN, DGAI, DGINA, DGfK und DGK.

The prevalence of patients living with long-term mechanical circulatory support (MCS) is rapidly increasing due to improved technology, improved survival, reduced adverse event profiles, greater reliability and mechanical durability, and limited numbers of organs available for donation. Patients with long-term MCS are very likely to require emergency medical support due to MCS-associated complications (e.g., right heart failure, left ventricular assist device malfunction, hemorrhage and pump thrombosis) but also due to non-MCS-associated conditions. Because of the unique characteristics of mechanical support, management of these patients is complicated and there is very little literature on emergency care for these patients. The purpose of this national scientific statement is to present consensus-based recommendations for the initial evaluation and resuscitation of adult patients with long-term MCS.

[Recommendations for emergency management of patients with permanent mechanical circulatory support : Consensus statement of DGTHG, DIVI, DGIIN, DGAI, DGINA, DGfK and DGK]. / Empfehlungen zum Notfallmanagement von Patienten mit permanenten Herzunterstützungssystemen : Konsensuspapier der DGTHG, DIVI, DGIIN, DGAI, DGINA, DGfK und DGK.

The prevalence of patients living with long-term mechanical circulatory support (MCS) is rapidly increasing due to improved technology, improved survival, reduced adverse event profiles, greater reliability and mechanical durability, and limited numbers of organs available for donation. Patients with long-term MCS are very likely to require emergency medical support due to MCS-associated complications (e.g., right heart failure, left ventricular assist device malfunction, hemorrhage and pump thrombosis) but also due to non-MCS-associated conditions. Because of the unique characteristics of mechanical support, management of these patients is complicated and there is very little literature on emergency care for these patients. The purpose of this national scientific statement is to present consensus-based recommendations for the initial evaluation and resuscitation of adult patients with long-term MCS.

[Acute right heart failure on the intensive care unit : Pathophysiology, monitoring and management]. / Akutes Rechtsherzversagen auf der Intensivstation : Pathophysiologie, Monitoring, Therapie.

Right ventricular heart failure is a frequent and serious but often undetected and complex clinical challenge on the intensive care unit. The commonest causes include acute decompensation of pulmonary hypertension, pulmonary embolism, sepsis, acute respiratory distress, and cardiothoracic surgery. The gold standard of bedside diagnosis is a combination of clinical symptoms, biochemical markers (NT-proBNP) and echocardiography. For the purposes of hemodynamic monitoring and treatment management, the indication to place a pulmonary artery catheter should be made generously. The major components of management include treating the underlying disease and triggering factors, reducing pulmonary vascular resistance, increasing contractility, volume optimization, and maintenance of adequate perfusion. Mechanical circulatory support should be considered before irreversible end-organ failure develops.

Extracorporeal membrane oxygenation for acute respiratory distress syndrome in adults: an analysis of differences between survivors and non-survivors.

OBJECTIVES: Over the last decade, extracorporeal membrane oxygenation (ECMO) has become a promising option for patients with severe acute respiratory distress syndrome (ARDS). In this single-center observational cohort study, data from a patient group with severe ARDS treated with ECMO was analyzed. METHODS: Data from 46 patients [median age 54 years (18 to 72), male: 65.2%] were evaluated retrospectively between January 2009 and September 2015. RESULTS: Diagnosis leading to ARDS was pneumonia in 63.1% of the patients. The median SOFA Score was 13 (10 to 19) and the median LIS was 3.5 (2.67 to 4). The median duration of ECMO support was 12 days (1 to 86). Twenty-eight patients (60.9%) were successfully weaned from ECMO and 22 patients survived (47.8%). Non-survivors needed significantly more frequent renal replacement therapy (37.5% vs. 18.2%; p<0.01) and transfusion of red blood cell concentrates [0.4 units (0.3 to 1.2) vs. 0.9 units (0.5 to 1.6); p<0.01] during ECMO support compared to patients who survived. CONCLUSION: This report suggests that ECMO currently allows treatment of severe ARDS with presumed improved survival. The incidence rate of acute kidney injury and transfusion are associated with adverse outcomes.

Prevalence, Diagnosis, Perioperative Monitoring and Treatment of Right Ventricular Dysfunction and/or Pulmonary Arterial Hypertension in Cardiac Surgical Patients in Germany-A Postal Survey.

Background Sparse data are available on the prevalence of right ventricular dysfunction and/or pulmonary arterial hypertension in patients scheduled for cardiac surgery in Germany as well as on the intensity and modalities used for diagnosis, perioperative monitoring, and treatment of these comorbidities. Methods A postal survey including questions on the prevalence of preoperative right ventricular dysfunction and/or pulmonary arterial hypertension in patients undergoing cardiac surgery in 2009 was sent to 81 German heart centers. Total 47 of 81 (58%) heart centers returned the questionnaires. The centers reported data on 51,095 patients, and 49.8% of the procedures were isolated coronary artery bypass grafting. Results Data on the prevalence of preoperative pulmonary hypertension and/or right ventricular dysfunction were not available in 54% and 64.6% of centers. In the remaining hospitals, 19.5% of patients presented right heart dysfunction and 10% pulmonary arterial hypertension. Preoperative echocardiography was performed in only 45.3% of the coronary artery bypass grafting cases. Preoperative pharmacologic treatment of pulmonary hypertension or right ventricular dysfunction with oral sildenafil, inhaled prostanoids, or nitric oxide was initiated in 71% and 95.7% of the centers, respectively. Intra- and postoperative treatment was most frequently accomplished with phosphodiesterase-III inhibitors. Conclusion The prevalence of preoperative right heart dysfunction and pulmonary arterial hypertension in cardiac surgical patients in Germany seems to be substantial. However, in more than 50% of the patients, no preoperative data on right ventricular function and pulmonary arterial pressure are available. This may lead to underestimation of perioperative risk and inappropriate management of this high-risk population.

Physicochemical compatibility and emulsion stability of propofol with commonly used analgesics and sedatives in an intensive care unit.

OBJECTIVES: The purpose of this study was the determination of the physicochemical compatibility and emulsion stability of propofol with other sedatives and analgesics (clonidine hydrochloride, dexmedetomidine, 4-hydroxybutyric acid, (S)-ketamine, lormetazepam, midazolam hydrochloride, piritramide, remifentanil hydrochloride and sufentanil citrate) that are frequently administered together intravenously. METHODS: Drugs were mixed with propofol and stored without light protection at room temperature. Samples were taken at 10 points of time over 7 days. The physical stability and emulsion stability in particular were analysed by visual and microscopical inspection and by measurement of the pH value, zeta potential and globule size distribution. In addition, high-performance liquid chromatography and mass spectrometry were used to identify chemical incompatibilities. RESULTS: 4-Hydroxybutyric acid, midazolam hydrochloride, piritramide and remifentanil hydrochloride are physically incompatible when mixed with propofol. The reason for this is the development of an increased fraction of oil droplets >5 µm leading to a higher risk of emboli. Moreover, propofol is chemically incompatible with remifentanil. The sorption of propofol to the rubber stopper of the syringe was another detectable incompatibility. CONCLUSIONS: Propofol should not be administered with 4-hydroxybutyric acid, remifentanil hydrochloride, midazolam hydrochloride and piritramide through the same intravenous line. Based on the risk of sorption to the rubber material, propofol should be used with caution. A drug loss might occur that leads to an underdosing of the patient requiring a dose adjustment to avoid any adverse consequences. As a result of this study, the drug safety in intensive care units could be optimised.

Is universal antifungal prophylaxis mandatory in adults after lung transplantation? A review and meta-analysis of observational studies.

BACKGROUND: Lung transplant (LTX) recipients are at high risk of invasive Aspergillus infections (IAI). However, no randomized-controlled trials (RCT) or international guidelines on antifungal prophylaxis (AFP) in the LTX population exist. METHODS: A meta-analysis was performed to determine whether AFP reduces the rate of IAI after LTX. A total of six eligible observational studies (five with no prophylaxis, one with targeted prophylaxis, three studies including heart/lung transplantation) with a total of 748 patients were included. RESULTS: The pooled odds ratio (OR) for IAI (62 IFI in the intervention arm and 82 in the control group) was 0.234 (95% confidence interval [CI] 0.097-0.564, P=0.001, z=-3.237). Pooled studies were characterized by substantial heterogeneity (I2 =66.64%); number needed to treat was 6.8. A subgroup analyses with exclusion of heart transplant recipients also showed a statistically significant reduction in IAI with AFP (OR 0.183, 95% CI 0.0449-0.744, P=0.018). CONCLUSION: This study suggests that universal antifungal prophylaxes reduces incidence of IAI after LTX. However, included studies are limited by small sample size, single-center structure without randomization, mixed population (including heart/heart-lung transplant), and heterogeneity due to variations in immunosuppression, type, and duration of AFP. Therefore, there is a clear need for an adequately powered RCT.

Preoperative intra-aortic counterpulsation in high-risk patients undergoing cardiac surgery: a meta-analysis of randomized controlled trials†.

In contrast to the results of previous studies, recent randomized controlled trials (RCTs) failed to show a benefit of prophylactic aortic counterpulsation in high-risk patients undergoing cardiac surgery. The present analysis aims to redefine the effects of this treatment modality in the light of this new evidence. MEDLINE, EMBASE, CENTRAL/CCTR, Google Scholar and reference lists of relevant articles were searched for full-text articles of RCTs in English or German. Assessments for eligibility, relevance, study validity and data extraction were performed by two reviewers independently using prespecified criteria. The primary outcome was hospital mortality. A total of nine eligible RCTs with 1171 patients were identified: 577 patients were treated preoperatively with intra-aortic balloon pump (IABP) and 594 patients served as controls. The pooled odds ratio (OR) for hospital mortality (22 hospital deaths in the intervention arm, 54 in the control group) was 0.381 (95% CI 0.230-0.629; P < 0.001). The pooled analyses of five RCTs including only patients undergoing isolated on-pump coronary artery bypass grafting (n[IABP] = 348, n[control] = 347) also showed a statistically significant improvement in mortality for preoperative IABP implantation (fixed-effects model: OR 0.267, 95% CI 0.129-0.552, P < 0.001). The pooled OR for hospital mortality from two randomized off-pump trials was 0.556 (fixed-effects model, 95% CI 0.207-1.493, P = 0.226). Preoperative aortic counterpulsation was associated with a significant reduction in low cardiac output syndrome (LCOS) in the total population (fixed-effects model: OR 0.330, 95% CI 0.214-0.508, P < 0.001) as well as in the subgroup of CAGB patients (fixed-effects model: OR 0.113, 95% CI 0.056-0.226, P < 0.001), whereas there was no benefit in the off-pump population (fixed-effects model: OR 0.555, 95% CI 0.209-1.474, P = 0.238). Preoperative IABP implantation was associated with a reduction of intensive care unit (ICU) stay in all investigated populations with a greater effect in the total population [fixed-effects model: standard mean difference (SMD) -0.931 ± 0.198, P < 0.001] as well as in the subgroup of CAGB patients (fixed-effects model: SMD -1.240 ± 0.156, P < 0.001), compared with the off-pump group (fixed-effects model: SMD -0.723 ± 0.128, P < 0.001). Despite contradictory results from recent trials, the present study confirms the findings of previous meta-analyses that prophylactic aortic counterpulsation reduces hospital mortality, incidence of LCOS and ICU requirement in high-risk patients undergoing on-pump cardiac surgery. However, owing to small sample sizes and the lack of a clear-cut definition of high-risk patients, an adequately powered, prospective RCT is necessary to find a definite answer to the question, if certain groups of patients undergoing cardiac surgery benefit from a prophylactic IABP insertion.

The Use of Extracorporeal Membrane Oxygenation Systems in Severe Accidental Hypothermia After Drowning: A Centre Experience.

Cardiopulmonary failure because of drowning with accidental hypothermia (AH) remains a major task for emergency care physicians. In this case series, we describe our experience in nine patients with cardiopulmonary failure after drowning with AH less than 35°C, who were provided on an emergency basis with extracorporeal life support (ECLS) system or extracorporeal membrane oxygenation (ECMO). Conservative rewarming methods are not considered for this study. Preclinical conditions and protocols were gathered. Surgical reports and clinical data sets were collected. Median age was 24 years (range, 6-75 years). Six patients were male. Climatic conditions mostly showed cold to frosty weather. All cases had different preclinical rescue procedures. They reached the emergency department under cardiopulmonary resuscitation (CPR). Indications for ECLS were cardiac arrest, and in one case, pulmonary failure. Mean CPR duration was 60 min (range: 15-120 min). Before implantation, the median pH value was 6.9. Two patients could be successfully weaned from the systems. Cause of death was severe neurologic damage in six patients and cardiac failure in one patient. The use of ECLS/ECMO is a therapy option for a small range of patients with cardiopulmonary failure because of drowning with AH. Nevertheless, the interval of preclinical rescue remains extensively long.

Comparison of a New Miniaturized Extracorporeal Membrane Oxygenation System With Integrated Rotary Blood Pump to a Standard System in a Porcine Model of Acute Lung Injury.

Extracorporeal membrane oxygenation (ECMO) is used for severe acute respiratory distress syndrome. However, available ECMO systems are large and not well designed for fast delivery, emergency implantation, and interhospital transfer. Therefore, a new miniaturized oxygenator with integrated rotary blood pump (ILIAS) was developed and compared with a standard ECMO system in a large animal model. Acute lung injury was induced with repeated pulmonary saline lavage in 14 pigs until PaO2 /FiO2 -ratio was <100 mm Hg with a positive-end-expiratory-pressure of 5 mbar. Pigs were assigned to the following three groups: group 1 (n = 4): control group with conventional ventilation; group 2 (n = 5): standard vv-ECMO; group 3 (n = 5): vv-ILIAS. Gas exchange, hemodynamics, hemolysis, and coagulation activation were examined over a period of 8 h. No device failed during the observation period. PaCO2 decreased from 59.40 ± 4.14 mm Hg to 48.62 ± 4.50 mm Hg after 1 h in the ILIAS group compared with an improvement of PaCO2 from 48.86 ± 7.45 to 40.10 ± 6.02 in the conventional ECMO group (P = not significant [n.s.]). ARDS-induced respiratory acidosis was controlled promptly with a pH of 7.2 ± 0.1 at baseline increasing to 7.4 ± 0.1 in both study groups after 60 min of ECMO support. Mean carbon dioxide transfer was comparable between the conventional ECMO and ILIAS (211.36 ± 78.39 mL/min vs. 219.99 ± 76.72 mL/min, P = n.s.). PaO2 /FiO2 increased from 118.4 ± 15.5 mm Hg to 179.1 ± 72.4 mm Hg in the ILIAS group compared with an improvement of oxygenation from 107.1 ± 24.9 mm Hg to 179.0 ± 45.7 mm Hg in the standard ECMO group (P = n.s.). Mean oxygen transfer was calculated with 136.09 ± 30.25 mL/min for the ILIAS and 129.05 ± 36.28 mL/min for the standard ECMO. Hemodynamic instability or significant activation of the plasmatic coagulation was not observed. However, hemolysis was significantly higher in the ILIAS group compared with the conventional ECMO. As the ILIAS prototype provided excellent gas exchange with hemodynamic stability comparable with a standard ECMO system, we believe this study serves as a proof of concept. Further development and design modifications (optimized rotation speed and surface coating of rotor) are already done and another experiment is projected to reduce hemolysis and platelet consumption for clinical application.

[S3-Guideline: Recommendations for intra-aortic balloon pumping in cardiac surgery]. / S3-Leitlinie "Einsatz der intraaortalen Ballongegenpulsation in der Herzchirurgie".

Although intra-aortic balloon pumping (IABP) is the most frequently used mechanical cardiac assist device in cardiothoracic surgery, there are only guidelines for substantive sections of aortic counterpulsation including prophylactic and postoperative use. In contrast, evidence-based recommendations are still lacking concerning intraoperative use, management, contraindication and other relevant issues. According to international surveys, important aspects of IABP usage show a wide variation in clinical practice. The results of a national questionnaire performed before initiation of this guideline confirmed these findings and demonstrated a clear need for the development of a consensus-based guideline. Therefore, the presented multidisciplinary S-3-guideline was developed under the direction of the German Society for Thoracic and Cardiovascular Surgery (Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie, DGTHG) to make evidence-based recommendations for the usage of aortic counterpulsation after cardiothoracic surgery according to the requirements of the Association of the Scientific Medical Societies in Germany (AWMF) and the Medical Centre for Quality (Ärztliches Zentrum für Qualität - (ÄZQ)). Main topics discussed in this guideline involve IABP support in the prophylactic, preoperative, intraoperative and postoperative setting as well as the treatment of right heart failure, contraindications, anticoagulation, monitoring, weaning, and limitations of IABP therapy. The presented 15 key messages of the guideline were approved after two consensus meetings under moderation of the AWMF with participation of the German Society of Cardiology (DGK), German Society of Anaesthesiology and Intensive Care Medicine (DGAI), German Interdisciplinary Association for Intensive Care (DIVI) and the German Society for Cardiovascular Engineering (DGfK).

Comparison of a continuous noninvasive arterial pressure device with invasive measurements in cardiovascular postsurgical intensive care patients: a prospective observational study.

BACKGROUND: Arterial pressure monitoring using the a continuous noninvasive arterial pressure (CNAP) device during general anaesthesia is known to be interchangeable with continuous invasive arterial pressure (CIAP) monitoring. Agreement with invasive measurements in cardiovascular postsurgical intensive care patients has not been assessed. OBJECTIVE: The objective of this study is to assess the agreement and interchangeability of CNAP with CIAP in cardiovascular postsurgical patients and to determine the effects of cardiac arrhythmia, catecholamine dosage, respiratory weaning and calibration intervals on agreement. DESIGN: A prospective observational study. SETTING: German university hospital cardiovascular ICU. Data were collected from April 2010 to December 2011. PATIENTS: From 110 enrolled patients, 104 were included. Inclusion criteria were American Society of Anaesthesiologists (ASA) physical status III or IV patients undergoing controlled ventilation. Exclusion criteria included emergencies, complete heart block and marked arterial pressure differences greater than 10 mmHg in the two arms. MAIN OUTCOME MEASURES: Bland-Altman plots, bias, precision, 95% limits of agreement, percentage error and agreement : tolerability indexes (ATIs) were estimated to determine clinical agreement. RESULTS: From 11 222 arterial pressure readings, biases (SD) for CIAP-CNAP for systolic arterial pressure (SAP), diastolic arterial pressure (DAP) and mean arterial pressure (MAP) for all patients were 4.3 (11.6), -9.4 (8) and -6 (7.6) mmHg, respectively. Cardiac arrhythmia (4.1 (13.1), -14.4 (8.3), -9.5 (8.9) mmHg) and long interval to last calibration [4.5 (15), -9.8 (9.5), -6.4 (9.1) mmHg] impaired the accuracy of CNAP with failed interchangeability criteria defined by the percentage error. In contrast, use of catecholamines (epinephrine or norepinephrine infusions >0.1 µg kg min), short calibration intervals and weaning conditions did not affect accuracy, interchangeability and agreement, especially of MAP. Agreement was defined as acceptable for MAP for all data and subgroups (ATI 0.8 to 1.0) and at worst, marginal for SAP and DAP (ATI 0.9 to 1.6). CONCLUSION: CNAP showed acceptable agreement defined by the ATI with invasive measurements for MAP and partially for DAP, but there was considerable variability for SAP. MAP should be preferred for clinical decision making. Cardiac arrhythmia, in contrast to catecholamine dosage or weaning procedures, impaired the accuracy, agreement and interchangeability of CNAP. TRIAL REGISTRATION: Clinical trials.gov identifier NCT01003665.