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The aim of this study is to evaluate the differences between men and women undergoing cardiac surgery. We will look at perioperative factors such as body weight, body surface area, previous medical history, pharmacokinetics, transfusion, coagulation, cardiopulmonary bypass (CPB) related factors, cardiac function, inotropic requirements, risk, and outcome scores as well as morbidity and mortality at 30 and 90 days, 1, 5, and 10 years.
Observational, multicentre, retrospective data collection from the mandatory Quality Assurance database (the Netherlands Heart Registry, (NHR), supplemented with data from the electronic patient files (EPIC). The retrospective data is already available.
In addition, we will continue the retrospective study into a prospective registry of data after the analysis of the retrospective data. Patients will be approached one, five and ten years after the operation and a questionnaire will be sent to document quality of life. No research-related interventions other than questionnaires will be performed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Female | Female patients undergoing cardiac surgery |
| |
| Male | Male patients undergoing cardiac surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac surgery | Procedure | Cardiac surgery of all types |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint | Incidence of mortality (number of patients) specific (coagulation), transfusion products, anesthesia, surgery and cross-clamp times, etc | up to 30 days post-surgery |
| Primary endpoint | incidence of cerebrovascualar accident with neurological sequelae (number of patients) | up to 30 days post-surgery |
| Primary endpoint | incidence of acute kidney injury (number of patients) | up to 30 days post-surgery |
| Primary endpoint | incidence of low cardiac output syndrome, pulmonary and other complications (requiring ventilation > 48 hours post-operatively) | up to 30 days post-surgery |
| Primary endpoint | Number of specific (coagulation), transfusion products, | up to 30 days post-surgery |
| Primary outcome | Times: surgical, cross-clamp, bypass, anesthetic, intensive care admission, hospital admission, etc. | up to 30 days post-surgery or if still in hospital, until discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity and mortality | peroperative and post-operative complications | At 30, 90, 365 days |
| Survival | Long term survival | At 5 and 10 years |
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Inclusion Criteria:
Exclusion Criteria:
• Patients who object to the re-use of their care data or do not give consent
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The study population will consist of male and female patients, 18 years and older. The study group consists of all patients who underwent cardiac surgery from 1 January 2016 onwards, in either of the centres (AMC or VUmc). The registry will continue for at least 10 years after the inclusion of the last patient.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer S Breel, MSc | Contact | +31610019257 | j.s.breel@amsterdamumc.nl | |
| Susanne Eberl, PhD | Contact | +31610019257 | s.eberl@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Markus W Hollmann, Professor | Anesthesiology and Pain Medicine, Amsterdam Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Recruiting | Amsterdam | North Holland | 1105 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34606298 | Background | Cho L, Kibbe MR, Bakaeen F, Aggarwal NR, Davis MB, Karmalou T, Lawton JS, Ouzounian M, Preventza O, Russo AM, Shroyer AW, Zwischenberger BA, Lindley KJ. Cardiac Surgery in Women in the Current Era: What Are the Gaps in Care? Circulation. 2021 Oct 5;144(14):1172-1185. doi: 10.1161/CIRCULATIONAHA.121.056025. Epub 2021 Oct 4. | |
| 34520795 |
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| ID | Term |
|---|---|
| D006348 | Cardiac Surgical Procedures |
| ID | Term |
|---|---|
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |
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| Health related Quality of life measured by PROMS | Long term quality of life after cardiac surgery, measured by Seattle Angina Questionaire (SAQ), EuroQol Quality of life (EQ-5D-5L) and Coronary Revascularisation Outcome Questionnaire (CROQ) or other appropriate questionnaire | At 1, 5 and 10 years |
| Dixon LK, Di Tommaso E, Dimagli A, Sinha S, Sandhu M, Benedetto U, Angelini GD. Impact of sex on outcomes after cardiac surgery: A systematic review and meta-analysis. Int J Cardiol. 2021 Nov 15;343:27-34. doi: 10.1016/j.ijcard.2021.09.011. Epub 2021 Sep 11. |
| 34776353 | Background | Nanegrungsunk D, Patel S, Jan T, Ngai JY. Preoperative Care Practice for Female Cardiac Patients: A Survey From the Society of Cardiovascular Anesthesiologists. J Cardiothorac Vasc Anesth. 2022 Mar;36(3):920-921. doi: 10.1053/j.jvca.2021.09.054. Epub 2021 Oct 3. No abstract available. |
| 34524421 | Background | Peters SAE, Kluin J. Why do women do worse after coronary artery bypass grafting? Eur Heart J. 2021 Dec 28;43(1):29-31. doi: 10.1093/eurheartj/ehab617. No abstract available. |