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1.
Article in English | MEDLINE | ID: mdl-38944031

ABSTRACT

OBJECTIVES: The healthcare registries in Denmark present a unique opportunity to gain novel insights into the outcomes associated with both transcatheter and surgical approaches to aortic valve replacement. Our objective is to enhance shared decision-making by comparing long-term mortality and clinical outcomes between treatments. METHODS: This observational study included all patients with severe aortic stenosis undergoing elective isolated transfemoral transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) in Western Denmark between January 2016 and April 2022. Patient population and clinical data were identified from the Western Danish Heart Registry and the National Danish Patient Registry, respectively. A propensity score-matched population was generated. Outcomes were investigated according to Valve Academic Research Consortium-3. RESULTS: A total of 2269 TAVI patients and 1094 SAVR patients where identified. The propensity score-matched population consisted of 468 TAVI patients (mean[SD]age, 75.0[5.3] years) and 468 SAVR patients (mean[SD] age, 75.1[4.6]years). The Kaplan-Meier estimate for the 5-year all-cause mortality was 29.8% in the TAVI group and 16.9% for in the SAVR group (P = 0.019). The risk of all stroke or transient ischaemic attack after five year was 15.1% in the TAVI group and 11.0% in the SAVR group (P = 0.047). CONCLUSIONS: This study underscores the importance of evaluating all patient factors when choosing an aortic valve replacement method. Surgical aortic valve replacement was an excellent choice, especially for patients with New York Heart Association class I/II, ≥75 age, left ventricular ejection fraction ≥50%, or longer life expectancy.

2.
Article in English | MEDLINE | ID: mdl-38775645

ABSTRACT

OBJECTIVES: It is uncertain whether Thunderbeat has a place in harvesting the left internal mammary artery (LIMA) and whether skeletonization is superior to pedicle-harvested LIMA. Some investigations have shown improved flowrates in the skeletonized graft. The aim of this study was to compare 3 groups of harvesting techniques: Pedicled, surgical skeletonized and skeletonized with Thunderbeat in terms of flow rates in the LIMA and postoperative in-hospital outcomes. METHODS: Patients undergoing coronary artery bypass grafting with the LIMA to the anterior descending artery were randomized to pedicled (n = 56), surgical skeletonized (n = 55) and skeletonized with Thunderbeat (n = 54). Main outcomes were blood flow and pulsatility index in the graft. RESULTS: No statistical difference between groups regarding flow in LIMA or pulsatility index. Similarly, no difference in postoperative bleeding or days of hospitalization. The duration of harvesting was faster for the pedicled technique compared with surgical skeletonized and skeletonized with Thunderbeat [mean total min: pedicled 20.2 min standard deviation (SD) ± 5.4; surgical skeletonized 28.6 min SD ± 8.7; skeletonized with Thunderbeat 28.3 min SD ± 9.11, P < 0.001]. No grafts discarded due to faulty harvesting and there was no graft failure within hospital stay. CONCLUSIONS: We found no difference between the harvesting methods except for a significantly faster harvesting time with the pedicled technique. However, non-touch skeletonized LIMA harvesting with Thunderbeat seems to be an effective alternative to traditional surgical skeletonized LIMA. The future will reveal whether patency is harvesting dependent. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05562908.

3.
BMJ Open ; 13(5): e069595, 2023 05 10.
Article in English | MEDLINE | ID: mdl-37164465

ABSTRACT

INTRODUCTION: Atrial fibrillation (AF) is the most common postoperative complication after surgical aortic valve replacement (SAVR) and occurs in up to 50% of the patients. Development of postoperative AF (POAF) is associated with a 2-3 fold increased risk of adverse events, including stroke, myocardial infarction and death.Several studies have implied that prophylactic Atorvastatin therapy could prevent POAF in patients undergoing coronary artery bypass graft. These studies suggest that Atorvastatin has rapid and significant pleiotropic actions that reduce the risk of POAF. However, prophylactic treatment with statins has yet to be understood in SAVR. The aim of this study is to investigate whether prophylactic administration of torvastatin reduces POAF in patients undergoing SAVR. METHODS AND ANALYSIS: In this investigator-initiated, prospective, parallel-group, randomised, double-blind, placebo-controlled single-centre trial, 266 patients undergoing elective solitary SAVR with bioprosthetic valve, with no prior history of AF, and statin-naïve will be randomised (1:1) to treatment with Atorvastatin (80 mg once daily) or matching placebo for 1-2 weeks prior to and 30 days after surgery. The primary endpoint is POAF defined as an episode of irregular RR-intervals without a traceable p-wave of at least 30 s duration. After discharge and until day 30 after surgery, POAF will be documented by either rhythm strip or 12-lead ECG. ETHICS AND DISSEMINATION: Protocol approval has been obtained from the Regional Scientific Ethical Committee for Southern Denmark (S-20210159), The Danish Medicines Agency (2021103821) and the Data Protection Agency (21/65621).The trial is conducted in accordance with the Declaration of Helsinki, the ICH-GCP (International Conference on Harmonisation Good Clinical Practice) guidelines and the legal regulations of Denmark. Study findings will be shared via peer-reviewed journal publication and conference presentations. TRIAL REGISTRATION NUMBER: NCT05076019.


Subject(s)
Atrial Fibrillation , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Humans , Adult , Atorvastatin/therapeutic use , Atrial Fibrillation/etiology , Atrial Fibrillation/prevention & control , Aortic Valve/surgery , Prospective Studies , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Denmark , Hospitals , Postoperative Complications/etiology , Randomized Controlled Trials as Topic
4.
Circ Cardiovasc Qual Outcomes ; 14(6): e007302, 2021 06.
Article in English | MEDLINE | ID: mdl-34078097

ABSTRACT

BACKGROUND: In coronary artery bypass grafting (CABG), the use of fractional flow reserve (FFR) is insufficiently investigated. Stenosis assessment usually relies on visual estimates of lesion severity. This study evaluated health-related quality of life (HRQoL) and angina after FFR- versus angiography-guided CABG. METHODS: One hundred patients referred for CABG were randomized to FFR- or angiography-guided CABG. In the FFR group, lesions with FFR>0.80 were deferred, while the surgeon was blinded to the FFR values in the angiography group. Before and 6 months after CABG, HRQoL was assessed by the health state classifier EQ-5D of the EuroQoL 5-level instrument and angina status based on the Canadian Cardiovascular Society classification system were registered. RESULTS: Six-month angiography included FFR evaluations of deferred lesions. In total, completed EQ-5D of the EuroQoL 5-level instrument questionnaires were available in 86 patients (43 in the FFR versus 43 in the angiography-guided group). HRQoL was significantly improved and angina significantly decreased from baseline to 6 months after CABG with no difference between the randomization groups. Graft failure rates and clinical outcomes were similar in both groups. Patients with graft failure or FFR<0.80 of the previous deferred lesions had significantly lower visual analogue scale scores (78.7±14.2 versus 86.8±14.7, P=0.004) and more angina compared with patients without graft failure or FFR≥0.80 at 6-month follow-up. CONCLUSIONS: FFR- versus angiography-guided CABG demonstrated similar improvements in HRQoL and angina 6 months after CABG. Graft failure or low FFR in deferred lesions were associated with low HRQoL and angina. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02477371.


Subject(s)
Coronary Artery Disease , Coronary Stenosis , Fractional Flow Reserve, Myocardial , Triallate , Canada , Coronary Angiography , Coronary Artery Bypass/adverse effects , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/surgery , Humans , Quality of Life , Random Allocation , Treatment Outcome
5.
Semin Thorac Cardiovasc Surg ; 31(3): 350-358, 2019.
Article in English | MEDLINE | ID: mdl-30529158

ABSTRACT

Bioprosthetic aortic valves degenerate over time, and differences between brands could be expected. We compared 2 brands implanted in 3 different centers serving 3.3 million people. Between 2000 and 2014, we identified 1241 bioprosthetic aortic valve replacements using Mitroflow (Sorin, Milan, Italy) and 3212 using Perimount (Edwards Lifesciences, Irvine, CA) covering 88% of all aortic valve replacements in the region. Average differences in t-year mortality were derived from Cox regression. The complete case analyses included 881 Mitroflow replacements and 2488 Perimount replacements. The median follow-up time and 25/75 percentiles were 5.0 years (3.3-7.2) and 8.4 years (5.1-10.6) for Perimount and Mitroflow, respectively. Multiple Cox regression analyses demonstrated significantly higher mortality with Mitroflow valves compared with Perimount (hazard ratio 1.27; 95% CI: 1.1-1.5; P < 0.001). Average risk of death within 5 years was 25.0% with Mitroflow and 20.4% with Perimount. Average difference in 5-year mortality based on Cox regression was 4.60% in favor of Perimount (95% CI: 1.02-8.02%; P = 0.01) and the number needed to harm was 21.9 (95% CI: 12.7-80.5) within 5 years. Propensity matching confirmed 2-year survival differences 4.6% in favor of Perimount (95% CI: 1.2-7.9%; P = 0.004), and further confirmed in a series of subgroups and a double robust analysis that takes into account both propensity for treatment and covariate relation to outcome. Mitroflow valves were associated with a significantly increased risk of death when compared to Perimount valves.


Subject(s)
Aortic Valve/surgery , Bioprosthesis , Heart Valve Diseases/surgery , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis , Aged , Aged, 80 and over , Aortic Valve/physiopathology , Denmark , Female , Heart Valve Diseases/mortality , Heart Valve Diseases/physiopathology , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/mortality , Humans , Male , Middle Aged , Prosthesis Design , Prosthesis Failure , Recovery of Function , Registries , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
6.
J Am Coll Cardiol ; 72(22): 2732-2743, 2018 12 04.
Article in English | MEDLINE | ID: mdl-30497559

ABSTRACT

BACKGROUND: The value of fractional flow reserve (FFR) evaluation of coronary artery stenosis in coronary artery bypass grafting (CABG) is uncertain, and stenosis assessments usually rely on visual estimates of lesion severity. OBJECTIVES: This randomized clinical trial evaluated graft patency and clinical outcome after FFR-guided CABG versus angiography-guided CABG. METHODS: A total of 100 patients referred for CABG were randomly assigned to FFR-guided or angiography-guided CABG. Based on the coronary angiogram, a heart team made a graft plan for all patients, and FFR evaluations were performed. In FFR-guided CABG, coronary lesions with FFR >0.80 were deferred, and a new graft plan was designed accordingly, whereas the surgeon was blinded to the FFR values in patients who underwent angiography-guided CABG. The primary endpoint was graft failure in the percentage of all grafts after 6 months. RESULTS: Angiographic follow-up at 6 months was available for 72 patients (39 vs. 33 in the FFR-guided and angiography-guided groups, respectively). Graft failures of all grafts were similar in both groups (16% vs. 12%; p = 0.97). Rates of death, myocardial infarction, and stroke were also similar in the study groups, and no difference was seen in revascularization before angiographic follow-up. After 6 months, deferred lesions (n = 24) showed a significant reduction in mean FFR from index to follow-up (0.89 ± 0.05 vs. 0.81 ± 0.11; p = 0.002). Index FFR did not influence graft patency. CONCLUSIONS: FFR-guided CABG had similar graft failure rates and clinical outcomes as angiography-guided CABG. However, FFR was reduced significantly after 6 months in deferred lesions. (Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization [FARGO]; NCT02477371).


Subject(s)
Coronary Angiography/methods , Coronary Artery Bypass/methods , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/surgery , Fractional Flow Reserve, Myocardial/physiology , Aged , Coronary Angiography/adverse effects , Coronary Angiography/mortality , Coronary Artery Bypass/adverse effects , Coronary Artery Bypass/mortality , Coronary Stenosis/mortality , Female , Follow-Up Studies , Humans , Male , Middle Aged , Myocardial Infarction/diagnostic imaging , Myocardial Infarction/etiology , Myocardial Infarction/mortality , Prospective Studies , Single-Blind Method , Stroke/diagnostic imaging , Stroke/etiology , Stroke/mortality
7.
Ugeskr Laeger ; 180(20A)2018 Oct 01.
Article in Danish | MEDLINE | ID: mdl-30274590

ABSTRACT

During the latest decade, transcatheter aortic valve implantation (TAVI) has evolved from being indicated only in patients with severe aortic stenosis and prohibitive or high surgical risk, to be an alternative to surgical aortic valve replacement in patients with intermediate surgical risk. Improvements of the peri-procedural management have resulted in marked reduction of complications and an increasing number of patients treated with TAVI every year in Denmark. By a minimalist approach, TAVI can be performed in local anesthaesia, with same day mobilisation and discharge within few days, without affecting the safety.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Aortic Valve , Denmark , Humans , Risk Factors , Treatment Outcome
8.
Clin Epidemiol ; 8: 503-508, 2016.
Article in English | MEDLINE | ID: mdl-27822091

ABSTRACT

AIM: The Danish Heart Registry (DHR) seeks to monitor nationwide activity and quality of invasive diagnostic and treatment strategies in patients with ischemic heart disease as well as valvular heart disease and to provide data for research. STUDY POPULATION: All adult (≥15 years) patients undergoing coronary angiography (CAG), percutaneous coronary intervention (PCI), coronary artery bypass grafting, and heart valve surgery performed across all Danish hospitals were included. MAIN VARIABLES: The DHR contains a subset of the data stored in the Eastern and Western Denmark Heart Registries (EDHR and WDHR). For each type of procedure, up to 70 variables are registered in the DHR. Since 2010, the data quality protocol encompasses fulfillment of web-based validation rules of daily-submitted records and yearly approval of the data by the EDHR and WDHR. DESCRIPTIVE DATA: The data collection on procedure has been complete for PCI and surgery since 2000, and for CAG as of 2006. From 2000 to 2014, the number of CAG, PCI, and surgical procedures changed by 231%, 193%, and 99%, respectively. Until the end of 2014, a total of 357,476 CAG, 131,309 PCI, and 60,831 surgical procedures had been performed, corresponding to 249,445, 100,609, and 55,539 first-time patients, respectively. The DHR generally has a high level of completeness (1-missing) of each procedure (>90%) when compared to the National Patient Registry. Variables important for assessing the quality of care have a high level of completeness for surgery since 2000, and for CAG and PCI since 2010. CONCLUSION: The DHR contains valuable data on cardiac invasive procedures, which makes it an important national monitoring and quality system and at the same time serves as a platform for research projects in the cardiovascular field.

9.
Dan Med J ; 62(12): A5162, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26621393

ABSTRACT

INTRODUCTION: Post-operative new-onset atrial fibrillation and flutter (POAF) is associated with increased morbidity and mortality following cardiac surgery. Registers and databases are important data sources for observational studies in this research area; hence, the aim was to assess the data validity of the POAF diagnosis in the Western Denmark Heart Registry (WDHR). METHODS: We studied a 25% random sample (n = 1,381) from a cohort of 5,532 patients who underwent coronary artery bypass grafting, valve surgery or combinations between 1 January 2011 and 31 December 2013. Registrations of POAF diagnoses in the WDHR were compared with the actual clinical course as documented in the medical records. The positive predictive value for new-onset POAF in the WDHR was calculated. RESULTS: A positive predictive value of 82.5% (95% confidence interval: 78.8-85.7) was found with a sensitivity and specificity of 75.2% and 90.9%, respectively. CONCLUSIONS: A diagnosis of new-onset POAF in the WDHR is relatively valid and may be used for contemporary epidemiological studies. Improvements may optimise the registry's validity even further, emphasising the importance of continuous validation and maintenance of the registry. FUNDING: none. TRIAL REGISTRATION: not relevant.


Subject(s)
Atrial Fibrillation/diagnosis , Cardiac Surgical Procedures/adverse effects , Coronary Artery Bypass/adverse effects , Data Accuracy , Registries/standards , Adult , Aged , Aged, 80 and over , Atrial Fibrillation/etiology , Denmark , Female , Humans , Male , Middle Aged , Observational Studies as Topic/statistics & numerical data , Postoperative Period , Predictive Value of Tests , Retrospective Studies , Risk Factors
10.
Ann Intern Med ; 163(10): 737-46, 2015 Nov 17.
Article in English | MEDLINE | ID: mdl-26502223

ABSTRACT

BACKGROUND: Randomized clinical trials have found that early invasive strategies reduce mortality, myocardial infarction (MI), and rehospitalization compared with a conservative invasive approach in acute coronary syndromes (ACSs), but the effectiveness of such strategies in real-world settings is unknown. OBJECTIVE: To investigate adverse cardiovascular outcomes of an early versus a conservative invasive strategy in a national cohort of patients with ACSs. DESIGN: Retrospective cohort study. SETTING: Administrative health care data on hospitalizations, procedures, and outcomes abstracted from the Danish national registries and covering all acute invasive procedures in patients presenting with an ACS. PATIENTS: 19 704 propensity score-matched patients hospitalized with a first ACS between 1 January 2005 and 31 December 2011. MEASUREMENTS: Risk for cardiac death or rehospitalization for MI within 60 days of hospitalization. RESULTS: Compared with a conservative approach, early invasive strategies were associated with a lower risk for cardiac death (cumulative incidence, 5.9% vs. 7.6%; adjusted hazard ratio [HR], 0.75 [95% CI, 0.66 to 0.84]; P < 0.001). Similar results were found for rehospitalization for MI (cumulative incidence, 3.4% vs. 5.0%; adjusted odds ratio, 0.67 [CI, 0.58 to 0.77]; P < 0.001) and all-cause death (cumulative incidence, 7.3% vs. 10.6%; adjusted HR, 0.65 [CI, 0.59 to 0.72]; P < 0.001). LIMITATION: Potential residual confounding due to lack of core clinical variables. CONCLUSION: In this real-world cohort of patients with a first hospitalization for an ACS, the use of an early invasive treatment strategy was associated with a lower risk for cardiac death and rehospitalization for MI compared with a conservative invasive approach. PRIMARY FUNDING SOURCE: Department of Cardiology, University Hospital Gentofte.


Subject(s)
Acute Coronary Syndrome/diagnostic imaging , Acute Coronary Syndrome/therapy , Coronary Angiography , Acute Coronary Syndrome/mortality , Aged , Aged, 80 and over , Cardiac Catheterization , Cause of Death , Denmark/epidemiology , Female , Hospitalization , Humans , Incidence , Male , Myocardial Infarction/epidemiology , Propensity Score , Retrospective Studies , Risk Factors , Time Factors
11.
Ann Card Anaesth ; 18(2): 138-42, 2015.
Article in English | MEDLINE | ID: mdl-25849679

ABSTRACT

INTRODUCTION: European system for cardiac operative risk evaluation (EuroSCORE) is a valuable tool in control of the quality of cardiac surgery. However, the validity of the risk score for the individual patient may be questioned. The present study was carried out to investigate whether the continued fall in short-term mortality reflects an actual improvement in late mortality, and subsequently, to investigate EuroSCORE as predictor of 1-year mortality. METHODS: A population-based cohort study of 25,602 patients from a 12-year period from three public university hospitals undergoing coronary artery bypass grafting (CABG) or valve surgery. Analysis was carried out based on EuroSCORE, age and co-morbidity factors (residual EuroSCORE). RESULTS: During the period the average age increased from 65.1 ± 10.0 years to 68.9 ± 10.7 years (P < 0.001, one-way ANOVA), and the number of females increased from 26.0% to 28.2% (P = 0.0012, Chi-square test). The total EuroSCORE increased from 4.67 to 5.68 while the residual EuroSCORE decreased from 2.64 to 1.83. Thirty-day mortality decreased from 4.07% in 1999-2000 to 2.44% in 2011-2012 (P = 0.0056; Chi-square test), while 1-year mortality was unchanged (6.50% in 1999-2000 vs. 6.25% in 2011-2012 [P = 0.8086; Chi-square test]). DISCUSSION: The study demonstrates that both co-morbidity and age has a great impact on 30-day mortality. However, with time the impact of co-morbidity seems less. Thus, age is more important than co-morbidity in late mortality. The various developments in short and long-term mortality are not readily explained. CONCLUSION: Although 30-day mortality of CABG and valve surgery patients has decreased during the 12-year period, the 1-year mortality remains the same.


Subject(s)
Coronary Artery Bypass/mortality , Heart Valves/surgery , Postoperative Complications/mortality , Age Factors , Aged , Analysis of Variance , Cohort Studies , Denmark/epidemiology , Female , Humans , Kaplan-Meier Estimate , Male , Risk Assessment , Risk Factors , Sex Factors
12.
Eur Heart J Cardiovasc Pharmacother ; 1(3): 157-65, 2015 07.
Article in English | MEDLINE | ID: mdl-27533989

ABSTRACT

AIMS: Coronary angiography holds a central role in the diagnosis of coronary heart disease. We studied temporal trends in referral patterns 2000-09. METHODS AND RESULTS: We identified 156 496 first-time coronary angiographies in 2000-09 in nationwide registries. Trends were analyzed in 2-year intervals. Numbers of acute (5943-10 707) and elective (17 294-25 550) procedures increased between 2000-01 and 2008-09. Mean age increased from 61.8 to 63.9 years (P < 0.001) and the proportion of females increased from 33 to 37% (P < 0.001). An increase in the number of patients with prior chronic heart failure (2866 vs. 3197), cerebrovascular disease (1790 vs. 2906), diabetes (2527 vs. 4593), and arrhythmias (2985 vs. 4733) was observed. The proportion of acute patients examined the same day as hospitalized increased from 56.6 to 83.1%. Odds ratios (95% confidence interval) for treatment with statins [3.42(3.27;3.57)], RAS-inhibitors [1.85(1.77;1.93)], and acetylsalicylic acid [1.43(1.37;1.49)] at the time of coronary angiography increased towards 2008-09. Elective patients received medical treatment more often than acute patients (P < 0.001). CONCLUSION: During a 10-year period, there was an increase in the mean age of patients and the proportion of female patients, and a 56% increase in number of coronary angiographies performed. The use of prophylactic cardiovascular drugs among these high-risk patients increased during our study period.


Subject(s)
Cardiovascular Agents/therapeutic use , Cerebrovascular Disorders/epidemiology , Coronary Angiography , Coronary Disease/diagnosis , Forecasting , Heart Failure/epidemiology , Population Surveillance , Adult , Aged , Comorbidity/trends , Coronary Disease/drug therapy , Coronary Disease/epidemiology , Denmark/epidemiology , Follow-Up Studies , Humans , Middle Aged , Retrospective Studies
13.
J Thorac Cardiovasc Surg ; 148(5): 1812-1819.e2, 2014 Nov.
Article in English | MEDLINE | ID: mdl-24613160

ABSTRACT

OBJECTIVE: To determine whether graft patency after on-pump and off-pump coronary artery bypass surgery is similar when performed using the same heparinization protocol. METHODS: In a randomized, controlled, multicenter trial, 900 patients more than 70 years of age received either on-pump or off-pump coronary artery bypass surgery. Heparin was given to achieve an activated clotting time of 400 seconds before arteriotomy in both groups. After the procedure, protamine sulfate was given to revert the activated clotting time to less than 120 seconds. Coronary angiography was performed 6 months after the operation and graft patency was assessed by independent blinded observers. RESULTS: A total of 481 patients underwent angiography. In the off-pump group, 561 (79%) of 710 grafts were open, 65 (9%) were stenotic, and 84 (12%) were occluded. In the on-pump group, 549 (86%) of 650 grafts were open, 38 (5%) were stenotic, and 63 (9%) were occluded. The difference between the proportion of open grafts was statistically significant in favor of on-pump surgery (P=.01). The proportion of open left internal thoracic artery grafts was 95% in both groups. Perioperative use of intracoronary shunts did not increase the risk of stenosis of the coronary artery distal to the anastomosis. CONCLUSIONS: Despite comparable heparinization, graft patency after off-pump surgery was inferior to that after on-pump surgery.


Subject(s)
Anticoagulants/administration & dosage , Cardiopulmonary Bypass/adverse effects , Coronary Artery Bypass, Off-Pump/adverse effects , Coronary Artery Bypass/adverse effects , Coronary Vessels/surgery , Heparin/administration & dosage , Vascular Patency , Aged , Coronary Angiography , Coronary Artery Bypass/methods , Coronary Vessels/diagnostic imaging , Coronary Vessels/physiopathology , Denmark , Drug Administration Schedule , Female , Heparin Antagonists/administration & dosage , Humans , Male , Protamines/administration & dosage , Risk Factors , Time Factors , Treatment Outcome
14.
Interact Cardiovasc Thorac Surg ; 18(5): 544-50, 2014 May.
Article in English | MEDLINE | ID: mdl-24468543

ABSTRACT

OBJECTIVES: The clinical classification of myocardial infarction (MI) into five types was introduced in 2007 as a component of the universal definition. A Type 5 MI was defined as a MI related to coronary artery bypass surgery. In a setting of patients undergoing elective coronary artery bypass grafting, we set out (i) to describe the pattern of multiple serial cardiac troponin I (cTnI) measurements within 72 h postoperatively and (ii) to determine the optimal cardiac troponin I cut-off value in ruling in or ruling out a Type 5 MI. METHODS: In 2011-2012, patients with two- and three-vessel disease scheduled for elective on-pump coronary artery bypass grafting were considered. Samples for cTnI were drawn before and 0, 2, 4, 6, 12, 24, 48 and 72 h after surgery. Analysis for cardiac troponin I was performed by use of the Abbott Architect c16000 system with an upper reference limit (URL) of 30 ng/l. The diagnosis of a Type 5 MI was prospectively made by a consultant cardiologist and was based on clinical, electrocardiographic and imaging data together with routine sampling and measurements of cTnI, but without knowledge of the results of serial study cTnI measurements. RESULTS: Of the 141 eligible patients, 99 (70%) qualified for final enrollment. In 8 patients (8%), the clinical diagnosis of a Type 5 MI was made. Patients without Type 5 MI (n = 91) had a median cTnI peak value of 7675 ng/l compared with 20 500 ng/l in Type 5 MI patients (P = 0.01). By use of receiver operating characteristic curves, optimal cut-off values for identifying Type 5 MI were defined as 7970 ng/l (corresponding to 266 times the URL) 12 h postoperatively and 9950 ng/l (corresponding to 331 times the URL) 24 h postoperatively. These cut-off values resulted in negative predictive values of 0.99 (12 h) and 0.99 (24 h). Positive predictive values were 0.23 (12 h) and 0.35 (24 h). CONCLUSIONS: In clinically stable patients undergoing elective coronary artery bypass grafting, measurements of cTnI are useful in ruling out a Type 5 MI.


Subject(s)
Cardiopulmonary Bypass , Coronary Artery Bypass , Coronary Artery Disease/surgery , Myocardial Infarction/diagnosis , Troponin I/blood , Aged , Area Under Curve , Biomarkers/blood , Cardiopulmonary Bypass/adverse effects , Coronary Artery Bypass/adverse effects , Coronary Artery Disease/blood , Coronary Artery Disease/complications , Coronary Artery Disease/diagnosis , Elective Surgical Procedures , Electrocardiography , Female , Humans , Male , Middle Aged , Myocardial Infarction/blood , Myocardial Infarction/classification , Myocardial Infarction/etiology , Predictive Value of Tests , ROC Curve , Risk Factors , Time Factors , Treatment Outcome
15.
Scand Cardiovasc J ; 47(3): 185-92, 2013 06.
Article in English | MEDLINE | ID: mdl-23566075

ABSTRACT

OBJECTIVE: To determine the cost-effective operative strategy for coronary artery bypass surgery in patients above 70 years. DESIGN: Randomized, controlled trial of 900 patients above 70 years of age subjected to coronary artery bypass surgery. Patients were randomized to either on-pump or off-pump coronary artery bypass surgery. Data on direct and indirect costs were prospectively collected. Preoperatively and six months postoperatively, quality of life was assessed using EuroQol-5D questionnaires. Perioperative in-hospital costs and costs of re-intervention were included. RESULTS: The Summary Score of EuroQol-5D increased in both groups between preoperatively and postoperatively. In the on-pump group, it increased from 0.75 (0.16) (mean (SD)) to 0.84 (0.17), while the increase in the off-pump group was from 0.75 (0.15) to 0.84 (0.18). The difference between the groups was 0.0016 QALY and not significantly different. The mean costs were 148.940 D.Kr (CI, 130.623 D.Kr-167.252 D.Kr) for an on-pump patient and 138.693 D.Kr (CI, 123.167 D.Kr-154.220 D.Kr) for an off-pump patient. The ICER base-case point estimate was 6,829,999 D.Kr/QALY. The cost-effectiveness acceptability curve showed 89% probability of off-pump being cost-effective at a threshold value of 269,400 D.Kr/QALY. CONCLUSIONS: Off-pump surgery tends to be more cost-effective than on-pump surgery. Long-term comparisons are warranted.


Subject(s)
Coronary Artery Bypass, Off-Pump/economics , Coronary Artery Bypass/economics , Coronary Artery Disease/economics , Coronary Artery Disease/surgery , Hospital Costs , Outcome and Process Assessment, Health Care/economics , Age Factors , Aged , Aged, 80 and over , Chi-Square Distribution , Coronary Artery Bypass/adverse effects , Coronary Artery Bypass, Off-Pump/adverse effects , Cost-Benefit Analysis , Denmark , Female , Humans , Male , Postoperative Complications/economics , Postoperative Complications/therapy , Prospective Studies , Quality of Life , Quality-Adjusted Life Years , Surveys and Questionnaires , Time Factors , Treatment Outcome
17.
Circulation ; 125(20): 2431-9, 2012 May 22.
Article in English | MEDLINE | ID: mdl-22523305

ABSTRACT

BACKGROUND: Conventional coronary artery bypass grafting performed with the use of cardiopulmonary bypass is a well-validated treatment for patients with ischemic heart disease. Off-pump coronary artery bypass grafting (OPCAB) has been suggested to reduce the number of perioperative complications, especially in elderly patients. METHODS AND RESULTS: In a multicenter, randomized trial, we assigned 900 patients >70 years of age to conventional coronary artery bypass grafting or OPCAB surgery. After 30 days, a blinded end-point committee assessed whether a combined end point of death, stroke, or myocardial infarction had occurred. At baseline and 6 months postoperatively, self-assessed quality of life was measured with the Medical Outcomes Study Short Form-36 and EuroQol-5D questionnaires. A 6-month follow-up of mortality was performed through the Danish National Registry. The proportion of patients experiencing the combined end point within 30 days was 10.2% for conventional coronary artery bypass grafting and 10.7% for OPCAB. Implied risk difference of 0.4% (with a 95% confidence interval, -3.6 to 4.4) showed nonsignificance in a standard test for equality (P=0.83) and for noninferiority with an inferiority margin of 0.5% (P=0.49). At the 6-month follow-up, mortality was 4.7% compared with 4.2% (P=0.75). Both groups showed significant improvement in self-assessed health-related quality of life. CONCLUSIONS: Both conventional coronary artery bypass grafting and OPCAB are safe procedures that improved the quality of life when performed in elderly patients. No major differences in intermediate-term outcomes were found. However, the noninferiority of OPCAB with the prespecified margin could not be confirmed.


Subject(s)
Coronary Artery Bypass, Off-Pump/mortality , Coronary Artery Bypass/mortality , Myocardial Infarction/mortality , Postoperative Complications/mortality , Quality of Life , Age Distribution , Aged , Aged, 80 and over , Denmark/epidemiology , Female , Follow-Up Studies , Humans , Incidence , Male , Morbidity , Risk Factors , Surveys and Questionnaires
18.
Interact Cardiovasc Thorac Surg ; 14(6): 709-13, 2012 Jun.
Article in English | MEDLINE | ID: mdl-22368106

ABSTRACT

At Odense University Hospital (OUH), 5-9% of all unselected cardiac surgical patients undergo reoperation due to excessive bleeding. The reoperated patients have an approximately three times greater mortality than non-reoperated. To reduce the rate of reoperations and mortality due to postoperative bleeding, we aim to identify risk factors that predict reoperation. A total of 1452 consecutive patients undergoing cardiac surgery using extracorporeal circulation (ECC) between November 2005 and December 2008 at OUH were analysed. Statistical tests were used to identify risk factors for reoperation. We performed a case-note review on propensity-matched patients to assess the outcome of reoperation for bleeding regarding morbidity and mortality. In total, 101 patients (7.0%) underwent surgical re-exploration due to excessive postoperative bleeding. Significant risk factors for reoperation for bleeding after cardiac surgery was low ejection fraction, high EuroSCORE, procedures other than isolated CABG, elongated time on ECC, low body mass index, diabetes mellitus and preoperatively elevated s-creatinine. Reoperated patients significantly had a greater increase in postoperative s-creatinine and higher mortality. Surviving reoperated patients significantly had a lower EuroSCORE and a shorter time on ECC compared with non-survivors. The average time to re-exploration was 155 min longer for non-survivors when compared with survivors.


Subject(s)
Cardiac Surgical Procedures/adverse effects , Postoperative Hemorrhage/surgery , Aged , Cardiac Surgical Procedures/mortality , Case-Control Studies , Chi-Square Distribution , Denmark , Female , Hospitals, University , Humans , Male , Middle Aged , Postoperative Hemorrhage/etiology , Postoperative Hemorrhage/mortality , Propensity Score , Registries , Reoperation , Risk Assessment , Risk Factors , Survival Analysis , Time Factors , Treatment Outcome
19.
Eur J Cardiothorac Surg ; 42(1): 114-20, 2012 Jul.
Article in English | MEDLINE | ID: mdl-22241009

ABSTRACT

OBJECTIVE: Numerous reports have emphasized the need for reduction in transfusions of allogeneic red blood cells (RBC) due to increased morbidity and mortality. Nevertheless, transfusion rates are still high in several cardiac surgery institutions. Reports on long-term survival after cardiac surgery and RBC transfusion are few. METHODS: Data from the Western Denmark Heart Registry (WDHR) were used to identify all (25,117) adult cardiac surgery performed in four centres during 1999-2010. Patients with multiple entries (1049), re-do cardiac surgery (985), special/complex procedures (2329), dying within 30 days (668) and not eligible for follow-up (85) were excluded leaving a cohort of 20,001. Registration in the WDHR is mandatory. WDHR and the unique Danish Civil Registration System with continuous sequential updates of the Danish population ensure that all patients and outcomes are accounted for. RESULTS: Kaplan-Meier survival plot for low-risk patients (EuroSCORE 0-4), undergoing simple cardiac surgery showed a significantly lower estimated survival after >4500 days (0.637 vs. 0.745) when receiving perioperative RBC transfusion (P<0.0001). The difference was less evident in patients with EuroSCORE 5-9 (0.373 vs. 0.4436, P<0.0001), while high-risk patients showed no difference. Adjusted risk ratio, after RBC transfusion, containing among others age, sex, EuroSCORE and diabetes, was 1.83 (95% CI (confidence interval) 1.67-2.01). The survival rate was independent of up till six units of RBC. CONCLUSION: Long-term follow-up of low-risk patients undergoing simple cardiac surgery demonstrates a more than 10% higher mortality when receiving perioperative RBC transfusion. Even transfusion of 1-2 units seems to carry a risk of that magnitude.


Subject(s)
Cardiac Surgical Procedures/mortality , Erythrocyte Transfusion/adverse effects , Perioperative Care/adverse effects , Adolescent , Adult , Aged , Aged, 80 and over , Denmark , Female , Follow-Up Studies , Humans , Male , Middle Aged , Odds Ratio , Outcome Assessment, Health Care , Registries , Risk Factors , Severity of Illness Index , Survival Analysis , Young Adult
20.
J Invasive Cardiol ; 24(1): 19-24, 2012 Jan.
Article in English | MEDLINE | ID: mdl-22210585

ABSTRACT

OBJECTIVE: To describe gender-specific long-term outcome and initiation of secondary preventive medication among patients with acute myocardial infarction (AMI). DESIGN: Observational cohort study. SETTING: Nationwide registries. PATIENTS: We included 18,279 patients: 6364 women (35%) and 11,915 men (65%), admitted with AMI (median age, 67 years; range, 30-90 years) surviving for at least 2 months. INTERVENTIONS: According to sex, patients were stratified by invasive treatment strategy: (1) revascularized; (2) examined with coronary angiography (CAG) but not revascularized; and (3) not examined with CAG. MAIN OUTCOME MEASURES: All-cause mortality and readmission with AMI. Initiation of secondary preventive medication. RESULTS: Of 18,279 patients with a first AMI who survived 2 months, 1857 women (29%) and 1756 men (15%) were not examined with CAG (P<.001), 1295 women (20%) and 1563 men (13%) were examined but not revascularized (P<.001), and 3212 women (51%) and 8596 men (72%) were revascularized (P<.001). Not being examined with CAG after AMI was associated with a three-fold increase in risk of death and, importantly, a 50% increase in the risk of a recurrent AMI compared with patients who were revascularized. Among patients who were revascularized, 85-92% initiated recommended secondary preventive medication compared to 46-71% in patients not examined with CAG (P<.001). Initiation of secondary preventive medication was higher in men (81-84%) than in women (73-79%; P<.001), which could be ascribed to the differences in invasive strategy. CONCLUSIONS: In both sexes, those who were not examined had a highly increased risk of both recurrent AMI and death. Moreover, initiation of secondary preventive medication was closely related to the choice of invasive strategy disfavoring the women.


Subject(s)
Angioplasty, Balloon, Coronary , Coronary Angiography , Coronary Artery Bypass , Myocardial Infarction/diagnosis , Myocardial Infarction/therapy , Secondary Prevention , Sex Characteristics , Adult , Aged , Aged, 80 and over , Cohort Studies , Denmark , Female , Humans , Longitudinal Studies , Male , Middle Aged , Myocardial Infarction/mortality , Outcome Assessment, Health Care , Prognosis , Recurrence , Registries , Survival Rate , Treatment Outcome
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