Usefulness of Discharge Resting Heart Rate to Predict Adverse Cardiovascular Outcomes in Patients With Left Main Coronary Artery Disease Revascularized With Percutaneous Coronary Intervention vs Coronary Artery Bypass Grafting (from the EXCEL Trial).

The prognostic impact of resting heart rate (RHR) following revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in patients with left main coronary artery disease (LMCAD) is unknown. We aimed to assess the effect of RHR at discharge on 3-year cardiovascular outcomes following PCI and CABG for LMCAD. In the EXCEL trial, 1,905 patients with LMCAD were randomized to PCI with everolimus-eluting stents versus CABG. RHR was measured at discharge following the index hospitalization. The principal outcome measure was the composite endpoint of death, myocardial infarction (MI) or stroke at 3 years. Among 1,303 patients in sinus rhythm with available ECGs, the median (IQR) discharge RHR was 72 (62to 81) bpm. Median discharge RHR was higher after CABG versus PCI (78 [IQR 70 to 86] versus 65 [IQR 59 to 74] bpm, p <0.0001). At 3 years, 107 patients (8.2%) had a primary composite endpoint event including 61 patients (4.7%) who died. By multivariable analysis, discharge RHR assessed as a continuous variable (per 5 bpm) was an independent predictor at 3 years of the primary composite endpoint of death, MI, or stroke (hazard ratio [HR] 1.15, 95% confidence interval [CI] 1.06 to 1.25, p = 0.0006); the secondary composite endpoint of death, MI, stroke, or ischemia-driven revascularization at 3 years (HR 1.12, 95% CI 1.05 to 1.19, p = 0.0007); all-cause mortality (HR 1.18, 95% CI 1.07 to 1.31, p = 0.002); and cardiovascular death (HR 1.16, 95% CI 1.00 to 1.33, p = 0.046). No significant interactions were present between RHR and treatment with PCI versus CABG for the primary (pint = 0.20) or secondary (pint = 0.47) composite endpoints. In patients with LMCAD undergoing revascularization, an increased RHR at discharge was associated with a higher risk for adverse cardiovascular outcomes at 3 years, irrespective of treatment modality.

Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease.

BACKGROUND: Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established. METHODS: We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction. RESULTS: At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], -0.9 to 6.5; P = 0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, -1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, -1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, -1.9 percentage points; 95% CI, -3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, -0.8 percentage points; 95% CI, -2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0). CONCLUSIONS: In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776.).

Off-Pump Versus On-Pump Bypass Surgery for Left Main Coronary Artery Disease.

BACKGROUND: Concerns remain for a greater risk of incomplete revascularization and reduced survival with off-pump coronary artery bypass grafting (CABG) surgery compared with on-pump surgery particularly in patients with left main disease and extensive underlying myocardial ischemia. OBJECTIVES: This study sought to compare outcomes following off-pump versus on-pump surgery for left main disease by performing a post hoc analysis from the multicenter, randomized EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial. METHODS: The EXCEL trial was designed to compare percutaneous coronary intervention with everolimus-eluting stents versus CABG in patients with left main disease. CABG was performed with or without cardiopulmonary bypass (on-pump vs. off-pump surgery) according to the discretion of the operator. The 3-year outcomes in the off-pump and on-pump groups were compared using inverse probability of treatment weighting (IPTW) for treatment effect estimation. RESULTS: Among 923 CABG patients, 652 and 271 patients underwent on-pump and off-pump surgery, respectively. Despite a similar extent of disease, off-pump surgery was associated with a lower rate of revascularization of the left circumflex coronary artery (84.1% vs. 90.0%; p = 0.01) and right coronary artery (31.1% vs. 40.6%; p = 0.007). After IPTW adjustment for baseline differences, off-pump surgery was associated with a significantly increased risk of 3-year all-cause death (8.8% vs. 4.5%; hazard ratio: 1.94; 95% confidence interval: 1.10 to 3.41; p = 0.02) and a nonsignificant difference in the risk for the composite endpoint of death, myocardial infarction, or stroke (11.8% vs. 9.2%; hazard ratio: 1.28; 95% confidence interval: 0.82 to 2.00; p = 0.28). CONCLUSIONS: Among patients with left main disease treated with CABG in the EXCEL trial, off-pump surgery was associated with a lower rate of revascularization of the coronary arteries supplying the inferolateral wall and an increased risk of 3-year all-cause death compared with on-pump surgery.

Impact of chronic obstructive pulmonary disease on prognosis after percutaneous coronary intervention and bypass surgery for left main coronary artery disease: an analysis from the EXCEL trial.

OBJECTIVES: Percutaneous coronary intervention (PCI) is often favoured over coronary artery bypass grafting (CABG) surgery for revascularization in patients with chronic obstructive pulmonary disease (COPD). We studied whether COPD affected clinical outcomes according to revascularization in the Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial, in which PCI with everolimus-eluting stents was non-inferior to CABG for the treatment of patients with left main coronary artery disease and low or intermediate SYNTAX scores. METHODS: Patients with a history of COPD were propensity score matched to those without COPD. Outcomes at 30 days and 3 years in both groups were compared in patients randomized to PCI versus CABG. RESULTS: COPD status was available for 1901 of 1905 randomized patients (99.8%), 148 of whom had COPD (7.8%). Propensity score matching yielded 135 patients with COPD and 675 patients without COPD. Patients with COPD had higher 3-year rates of the primary composite end point of death, myocardial infarction or stroke (31.7% vs 14.5%, P < 0.0001), death (17.1% vs 7.5%, P = 0.0005) and myocardial infarction (18.3% vs 7.3%, P < 0.0001), but not stroke (3.3% vs 2.9%, P = 0.84). There were no statistically significant interactions in the relative risks of PCI versus CABG for the primary composite end point in patients with and without COPD at 30 days [hazard ratio (HR) 0.39, 95% confidence interval (CI) 0.12-1.21 vs HR 0.55, 95% CI 0.29-1.06; Pinteraction = 0.61] or at 3 years (HR 0.85, 95% CI 0.46-1.56 vs HR 1.28, 95% CI 0.84-1.94; Pinteraction = 0.27). CONCLUSIONS: In the EXCEL trial, COPD was independently associated with poor prognosis after left main coronary artery disease revascularization. The relative risks of PCI versus CABG at 30 days and 3 years were consistent in patients with and without COPD. CLINICAL TRIAL REGISTRATION NUMBER: http://www.clinicaltrials.gov; NCT01205776.

Outcomes following surgical revascularization with single versus bilateral internal thoracic arterial grafts in patients with left main coronary artery disease undergoing coronary artery bypass grafting: insights from the EXCEL trial†.

OBJECTIVES: Observational data suggest that the use of a single internal thoracic artery (SITA) may result in inferior outcomes compared with bilateral internal thoracic artery (BITA) use for coronary artery bypass grafting (CABG)-a finding not yet supported by randomized trial outcomes. However, the optimal number of internal thoracic artery grafts in patients with left main coronary artery disease has not been investigated. METHODS: The EXCEL trial randomized 1905 patients with left main coronary artery disease to percutaneous coronary intervention with everolimus-eluting stents versus CABG. Among the 905 patients undergoing CABG, 688 (76.0%) received SITA and 217 (24.0%) received BITA. Differences in clinical event rates were estimated using the Kaplan-Meier method and compared with the log-rank test. Multivariable Cox regression was used to adjust for differences in baseline covariates. RESULTS: Compared to SITA, patients treated with BITA were younger (66.1 ± 9.5 vs 64.5 ± 9.3 years, P = 0.020), were less likely female (24.3% vs 14.3%, P = 0.002) and diabetic (28.8% vs 15.2%, P < 0.001), and had a lower prevalence of peripheral vessel disease (10.2% vs 5.5%, P = 0.040). The unadjusted 3-year composite primary endpoint of death, stroke or myocardial infarction (MI) occurred in 15.6% of SITA vs 11.6% of BITA patients (P = 0.17). The SITA group tended to have a higher 3-year rate of all-cause death compared with the BITA group (6.7% vs 3.3%; P = 0.070). Stroke, MI and ischaemia-driven revascularization outcomes were not significantly different between groups. After adjusting for baseline differences, neither the composite of death, stroke or MI [hazard ratio (HR) 1.12, 95% confidence interval (CI) 0.71-1.78; P = 0.62] nor mortality (HR 1.36, 95% CI 0.60-3.12; P = 0.46) was significantly higher with SITA. The rehospitalization rate after 3 years was higher in the SITA group (35.8% vs 26.0%, P = 0.008), a difference which was no longer present after multivariable adjustment (HR 1.27, 95% CI 0.93-1.74; P = 0.13). Sternal wound dehiscence within 30 days did not occur more often in the BITA group compared to the SITA group (1.8% vs 2.2%, P > 0.99). CONCLUSIONS: In the EXCEL trial, there were no clinical differences at 3 years between SITA or BITA revascularization in patients with left main coronary artery disease.

Outcomes After Left Main Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting According to Lesion Site: Results From the EXCEL Trial.

OBJECTIVES: The authors sought to determine the extent to which the site of the left main coronary artery (LM) lesion (distal bifurcation versus ostial/shaft) influences the outcomes of revascularization with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). BACKGROUND: Among 1,905 patients with LM disease and site-assessed SYNTAX scores of <32 randomized in the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, revascularization with PCI and CABG resulted in similar rates of the composite primary endpoint of death, myocardial infarction (MI), or stroke at 3 years. METHODS: Outcomes from the randomized EXCEL trial were analyzed according to the presence of angiographic core laboratory-determined diameter stenosis ≥50% involving the distal LM bifurcation (n = 1,559; 84.2%) versus disease isolated to the LM ostium or shaft (n = 293; 15.8%). RESULTS: At 3 years, there were no significant differences between PCI and CABG for the primary composite endpoint of death, MI, or stroke for treatment of both distal LM bifurcation disease (15.6% vs. 14.9%, odds ratio [OR]: 1.08, 95% confidence interval [CI]: 0.81 to 1.42; p = 0.61) and isolated LM ostial/shaft disease (12.4% vs. 13.5%, OR: 0.90, 95% CI: 0.45 to 1.81; p = 0.77) (pinteraction = 0.65). However, at 3 years, ischemia-driven revascularization occurred more frequently after PCI than CABG in patients with LM distal bifurcation disease (13.0% vs. 7.2%, OR: 2.00, 95% CI: 1.41 to 2.85; p = 0.0001), but were not significantly different in patients with disease only at the LM ostium or shaft (9.7% vs. 8.4%, OR: 1.18, 95% CI: 0.52 to 2.69; p = 0.68) (pinteraction = 0.25). CONCLUSIONS: In the EXCEL trial, PCI and CABG resulted in comparable rates of death, MI, or stroke at 3 years for treatment of LM disease, including those with distal LM bifurcation disease. Repeat revascularization rates during follow-up after PCI compared with CABG were greater for lesions in the distal LM bifurcation but were similar for disease isolated to the LM ostium or shaft.

Outcomes After Coronary Stenting or Bypass Surgery for Men and Women With Unprotected Left Main Disease: The EXCEL Trial.

OBJECTIVES: The aim of the present study was to assess outcomes after coronary artery bypass grafting surgery (CABG) and percutaneous coronary intervention (PCI) according to sex in a large randomized trial of patients with unprotected left main disease. BACKGROUND: In the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial, sex had a significant interaction effect with revascularization strategy, and women had an overall higher mortality when treated with PCI than CABG. METHODS: The EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial was a multinational randomized trial that compared PCI with everolimus-eluting stents and CABG in patients with unprotected left main disease. The primary endpoint was the composite of all-cause death, myocardial infarction, or stroke at 3 years. RESULTS: Of 1,905 patients randomized, 1,464 (76.9%) were men and 441 (23.1%) were women. Compared with men, women were older; had higher prevalence rates of hypertension, hyperlipidemia, and diabetes; and were less commonly smokers but had lower coronary anatomic burden and complexity (mean SYNTAX score 24.2 vs. 27.2, p < 0.001). By multivariate analysis, sex was not independently associated with either the primary endpoint (hazard ratio [HR]: 1.10; 95% confidence interval [CI]: 0.82 to 1.48; p = 0.53) or all-cause death (HR: 1.39; 95% CI: 0.92 to 2.10; p = 0.12) at 3 years. At 30 days, all-cause death, myocardial infarction, or stroke had occurred in 8.9% of woman treated with PCI, 6.2% of women treated with CABG, 3.6% of men treated with PCI, and 8.4% of men treated with CABG (p for interaction = 0.003). The 3-year rate of the composite primary endpoint was 19.7% in women treated with PCI, 14.6% in women treated with CABG, 13.8% in men treated with PCI, and 14.7% in men treated with CABG (p for interaction = 0.06). These differences were driven by higher periprocedural rates of myocardial infarction in women after PCI and in men after CABG. CONCLUSIONS: In patients with unprotected left main disease in the EXCEL trial, sex was not an independent predictor of adverse outcomes after revascularization. However, women undergoing PCI had a trend toward worse outcomes, a finding related to associated comorbidities and increased periprocedural complications. Further studies are required to determine the optimal revascularization modality in women with complex coronary artery disease.

One-year outcomes of patients with severe aortic stenosis and an STS PROM of less than three percent in the SURTAVI trial.

AIMS: The indication for transcatheter aortic valve implantation (TAVI) has evolved from inoperable patients to patients at increased surgical risk. In low-risk patients, surgical aortic valve replacement (SAVR) remains the standard of care. The aim of this study was to explore the outcomes of TAVI and SAVR in patients with a Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) score below 3% in the SURTAVI trial. METHODS AND RESULTS: In SURTAVI, patients at intermediate surgical risk based on Heart Team consensus were randomised to TAVI or SAVR. We stratified the overall patient population into quintiles based on the STS PROM score; the one-year mortality was correlated with the mean STS PROM score in each quintile. The quintiles were regrouped into three clinically relevant categories of STS score: less than 3%, 3 to <5%, and >5%. All-cause mortality or disabling stroke in each risk stratum was compared between TAVI and SAVR. Linear regressions between mean values of STS PROM in each quintile and observed all-cause mortality at one year showed great association for the global population (r2=0.92), TAVI (r2=0.89) and SAVR cohorts (r2=0.73). All-cause mortality or disabling stroke of TAVI vs. SAVR was 1.5% vs. 6.5% (p=0.04), 6.5% vs. 7.6% (p=0.52) and 13.5% vs. 11.0% (p=0.40) in the <3%, 3-5%, and ≥5% STS score strata, respectively. CONCLUSIONS: Among patients at intermediate surgical risk but with an STS PROM <3%, TAVI may achieve superior clinical outcomes compared to SAVR. These findings support the need for an adequately powered randomised trial to compare TAVI with SAVR in patients at low operative risk.

Impaired right ventricular ejection fraction after cardiac surgery is associated with a complicated ICU stay.

BACKGROUND: Right ventricular (RV) dysfunction is a known risk factor for increased mortality in cardiac surgery. However, the association between RV performance and ICU morbidity is largely unknown. METHODS: We performed a single-centre, retrospective study including cardiac surgery patients equipped with a pulmonary artery catheter, enabling continuous right ventricular ejection fraction (RVEF) measurements. Primary endpoint of our study was ICU morbidity (as determined by ICU length of stay, duration of mechanical ventilation, usage of inotropic drugs and fluids, and kidney dysfunction) in relation to RVEF. Patients were divided into three groups according to their RVEF; < 20%, 20-30%, and > 30%. RESULTS: We included 1109 patients. Patients with a RVEF < 20% had a significantly longer stay in ICU, a longer duration of mechanical ventilation, higher fluid balance, a higher incidence of inotropic drug usage, and more increase in postoperative creatinine levels in comparison to the other subgroups. In a multivariate analysis, RVEF was independently associated with increased ICU length of stay (OR 0.934 CI 0.908-0.961, p < 0.001), prolonged duration of mechanical ventilation (OR 0.969, CI 0.942-0.998, p = 0.033), usage of inotropic drugs (OR 0.944, CI 0.917-0.971, p < 0.001), and increase in creatinine (OR 0.962, CI 0.934-0.991, p = 0.011). CONCLUSIONS: A decreased RVEF is independently associated with a complicated ICU stay.

Right Ventricular Function After Cardiac Surgery Is a Strong Independent Predictor for Long-Term Mortality.

OBJECTIVE: To establish the all-cause mortality of right ventricular dysfunction after cardiac surgery in a heterogeneous group of cardiac surgery patients. DESIGN: Retrospective analysis of a heterogeneous group of 1,109 cardiac surgery patients in a 4-year period. SETTING: Single-center study in a tertiary teaching hospital. PARTICIPANTS: One thousand one hundred nine cardiac surgery patients. By protocol, patients were monitored with a pulmonary artery catheter, enabling continuous right ventricular ejection fraction (RVEF) measurements. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Measurements were performed once per minute for the first 24 postoperative hours and expressed as average over the complete period. Primary outcome was 2-year all-cause mortality. RVEF was categorized into 3 subgroups: <20%, 20-30%, and >30%. Median follow-up time was 739 days. Two-year mortality was significantly different across groups: 4.1% for patients with RVEF >30%, 8.2% in the group with RVEF 20-30%, and 16.7% for patients with RVEF <20%, p < 0.001. Additional risk factors for a poor RVEF were age, body weight, New York Heart Association class, chronic obstructive pulmonary disease, poor left ventricular function, and higher risk scores (Acute Physiology and Chronic Health Evaluation and European System for Cardiac Operative Risk Evaluation). In a multivariate analysis, RVEF as a continuous variable was associated independently with the primary outcome (odds ratio 0.95 confidence interval 0.91-0.99, p = 0.011.) Odds ratios for RVEF <20% were 1.88 (confidence interval 1.18-3.00, p = 0.008). CONCLUSIONS: Right ventricular function is associated independently with 2-year all-cause mortality in a heterogenic cardiac surgery population.

Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease.

BACKGROUND: Patients with obstructive left main coronary artery disease are usually treated with coronary-artery bypass grafting (CABG). Randomized trials have suggested that drug-eluting stents may be an acceptable alternative to CABG in selected patients with left main coronary disease. METHODS: We randomly assigned 1905 eligible patients with left main coronary artery disease of low or intermediate anatomical complexity to undergo either percutaneous coronary intervention (PCI) with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). Anatomic complexity was assessed at the sites and defined by a Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score of 32 or lower (the SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature, with 0 as the lowest score and higher scores [no upper limit] indicating more complex coronary anatomy). The primary end point was the rate of a composite of death from any cause, stroke, or myocardial infarction at 3 years, and the trial was powered for noninferiority testing of the primary end point (noninferiority margin, 4.2 percentage points). Major secondary end points included the rate of a composite of death from any cause, stroke, or myocardial infarction at 30 days and the rate of a composite of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses. RESULTS: At 3 years, a primary end-point event had occurred in 15.4% of the patients in the PCI group and in 14.7% of the patients in the CABG group (difference, 0.7 percentage points; upper 97.5% confidence limit, 4.0 percentage points; P=0.02 for noninferiority; hazard ratio, 1.00; 95% confidence interval, 0.79 to 1.26; P=0.98 for superiority). The secondary end-point event of death, stroke, or myocardial infarction at 30 days occurred in 4.9% of the patients in the PCI group and in 7.9% in the CABG group (P<0.001 for noninferiority, P=0.008 for superiority). The secondary end-point event of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years occurred in 23.1% of the patients in the PCI group and in 19.1% in the CABG group (P=0.01 for noninferiority, P=0.10 for superiority). CONCLUSIONS: In patients with left main coronary artery disease and low or intermediate SYNTAX scores by site assessment, PCI with everolimus-eluting stents was noninferior to CABG with respect to the rate of the composite end point of death, stroke, or myocardial infarction at 3 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776 .).

Transcatheter aortic valve implantation using a direct aortic approach: a single-centre Heart Team experience.

OBJECTIVES: The transaortic (TAo) approach has been introduced as an alternative to transapical and transaxillary aortic valve implantation for patients with symptomatic severe aortic stenosis in whom a transfemoral approach is not feasible. However, only very limited data from a minimal number of specialized centres are available on this approach. Therefore, the aim of this study was to evaluate the early postoperative 30-day outcomes of the direct aortic approach performed by a single-centre multidisciplinary Heart Team. METHODS: Between May 2011 and July 2013, 159 patients underwent transcatheter aortic valve implantation (TAVI) at our institution; of which, 44 were believed to benefit most from the TAo as assessed by a multidisciplinary Heart Team. All patients underwent an upper 'J' median hemi-sternotomy through a 6-cm incision. The evaluation of early operative results was made according to the Valve Academic Research Consortium (VARC) consensus criteria. These include device success endpoints and combined safety endpoints at 30 days. RESULTS: The mean age of the patients was 78 years, the mean logistic EuroSCORE was 25.9 ± 14.4% and the mean Society of the Thoracic Surgeons score 5.8 ± 4.5%. Seventeen patients (39%) underwent redo operations; 4 (9%) received a transcatheter valve in a degenerated bioprosthesis. The procedure was performed using the Medtronic CoreValve Revalving system in 36 patients, with the Edwards SAPIEN XT in 7 cases and the St Jude Medical Portico valve in 1. Device success was achieved in 90.8% of the cases. Complications included; major stroke (n = 1), re-exploration for cardiac tamponade (n = 3), transient renal failure requiring temporary haemodialysis (n = 1) and permanent pacemaker implantation (n = 5). There were no myocardial infarctions. The total 30-day mortality rate was 6.8% (3 patients). Postoperative intensive care unit stay was 2.6 ± 3.6 days, and the mean hospitalization was 12 ± 9.6 days. CONCLUSIONS: The TAo TAVI approach is feasible and offers a safe alternative for patients in whom a transfemoral approach is not feasible or desirable.

Muscle flaps or omental flap in the management of deep sternal wound infection.

The primary question addressed was whether muscle flaps (MFs) offer a significant advantage over an omental flap (OF) in the management of deep sternal wound infection (DSWI) following cardiovascular surgery in terms of outcome (morbidity and mortality). Altogether, 333 citations (from PubMed and EMBASE and using a manual search, without language restriction) were identified using the reported strategy. Focusing on publications from single institutions with experience with both types of flap in the treatment of DSWI, 16 studies represented the best evidence on the topic. The author, journal, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses were tabulated. These 16 observational studies covered 1046 patients, and all reported mortality rates. Unadjusted data from five of six studies investigating a possible association between mortality and flap type suggested a higher mortality rate following reconstruction with MFs. A meta-analysis of all six studies indicates a slight, but not significant, survival advantage for reconstruction with an OF [overall relative risk 1.29 (95% confidence interval 0.58-2.88)]. Thirteen studies reported on the number of individual postoperative complications for a total of 964 patients. Data, unadjusted for potentially confounding surgical factors, on complications following flap closure, such as complete or partial flap loss, haematoma, arm or shoulder weakness and chronic chest wall pain, suggested that these complications were more common following MF reconstruction. Four studies evaluated patients with recurrent sternal wound infection (n=521). Two of these were associated with a high incidence (>17.5%) of re-exploration for recurrent sternal infection following MF reconstruction. The most commonly reported complications following an OF were abdominal or diaphragmatic hernias, with an incidence of <5%. We conclude that the weight of current evidence is insufficient to prove the superiority of reconstruction with MFs to a laparotomy-harvested, OF in the treatment of DSWI. The results suggest that use of the omentum may be associated with lower mortality and fewer complications.

Coronary artery bypass graft (CABG) surgery patients in a clinical pathway gained less in health-related quality of life as compared with patients who undergo CABG in a conventional-care plan.

AIMS AND OBJECTIVES: The aim of this study is to determine the difference between clinical pathway (CP) and conventional care in terms of health-related quality of life (HRQoL) domains, depression and anxiety, as well as to determine the relative contribution of CP towards an improved HRQoL after coronary artery bypass graft (CABG). METHOD: A longitudinal quasi-experimental pre-test/post-test design was used to study and compare clinical outcome, HRQoL depression and anxiety for CP versus conventional-care patients after CABG. HRQoL was measured by using Sf-36, while depression and anxiety were measured by using hospital anxiety and depression scale. Length of stay and patient complications were derived from the hospital database. RESULTS: We found that implementing a CP decreased hospital delay from 2.50 (+/-7.19) to 1.80 (+/-1.60), which was statistically significant P = 0.002. We also found that patients in the conventional-care plan improved more than patients in the CP in HRQoL. Outcomes in favour of patients in the conventional-care trajectory were based on the difference between small effect sizes (ES) (> or =0.20 <0.50) for pathway patients and moderate ES (> or =0.50 <0.80) for conventional-care patients, except for the domain of physical functioning and physical component summary, where the ES for conventional care was large (>0.80). CONCLUSION: The aim of designing and implementing pathways is to decrease length of stay and costs, while maintaining quality of care and improving patient outcomes. Our findings suggest that these aims were not fulfilled in this CABG pathway. We recommend that when designing a CP, all patient-related characteristics, risk indicators, along with physiological status, be taken into consideration.

Prophylactic aortic root surgery in patients with Marfan syndrome: 10 years' experience with a protocol based on body surface area.

BACKGROUND: Current guidelines recommending prophylactic aortic root replacement in Marfan syndrome are based on absolute diameters of the aortic root. However, aortic root diameter is a function of body surface area (BSA). Here, we report our experience with a protocol for prophylactic aortic root replacement based on BSA. METHODS: Patients with established Marfan syndrome (Ghent criteria) and without prior aortic surgery were eligible for our study. Aortic root ratio was defined as the ratio between the observed aortic root diameter (as measured during annual echocardiography) and the maximum predicted aortic root diameter as calculated according to age and BSA. Replacement surgery was performed if dilatation of the aortic root during follow-up resulted in an aortic root ratio >/=1.3. RESULTS: Fifty-three patients fulfilled the entry criteria (24 men/29 women, median age at baseline 27 years, range 18-59 years). During follow-up between 1997 and 2007 (mean 4.7+/-3.2 years) four patients underwent uncomplicated aortic root replacement; two had an aortic root ratio >/=1.3 (aortic root diameters were 4.9 and 5.2 cm, respectively), one had aortic root dilatation of 0.4 cm/year and a positive family history for aortic dissection and one had an aneurysm of the ascending aorta as the primary indication. None of the patients in the whole group suffered from type A aortic dissection and there was no mortality. CONCLUSIONS: Although numbers are small, our protocol for prophylactic aortic root replacement in patients with Marfan syndrome based on BSA was effective in terms of preventing aortic dissection and mortality.

Excellent long-term clinical outcome after coronary artery bypass surgery using three pedicled arterial grafts in patients with three-vessel disease.

BACKGROUND: Long-term clinical outcome of complete arterial grafting in three-vessel disease is unknown. METHODS: We studied 344 patients who underwent complete arterial revascularization using the internal thoracic arteries and the right gastroepiploic artery. Freedom from major adverse cardiac events (MACE) was evaluated by the Kaplan-Meier method, and homogeneity of outcome in strata of patients was assessed using Cox proportional hazards modeling. RESULTS: Median follow-up of survivors was 9.3 years (range, 0.01 to 12.8 years). The 12-year freedom from MACE was 75.5%. For the composite of MACE, this was 86.9% for cardiovascular death, 93.3% for myocardial infarction, and 89.4% for reintervention. In patients aged older than 65 years, MACE occurred significantly more frequent, with a freedom from MACE of 65.8% compared with 82.6% in younger patients (hazard ratio, 3.4; 95% confidence interval, 2.1 to 5.6, p < 0.001). CONCLUSIONS: Complete arterial revascularization using both pedicled internal thoracic arteries and the gastroepiploic artery in patients with three-vessel disease resulted in an excellent long-term clinical outcome, especially in patients aged younger than 65 years.

Are the outcomes of clinical pathways evidence-based? A critical appraisal of clinical pathway evaluation research.

AIM AND OBJECTIVE: To evaluate the validity of study outcomes of published papers that report the effects of clinical pathways (CP). METHOD: Systematic review based on two search strategies, including searching Medline, CINAHL, Embase, Psychinfo and Picarta from 1995 till 2005 and ISI Web of Knowledge SM. We included randomized controlled or quasi-experimental studies evaluating the efficacy of clinical pathway application. Assessment of the methodological quality of the studies included randomization, power analysis, selection bias, validity of outcome indicators, appropriateness of statistical tests, direct (matching) and indirect (statistical) control for confounders. Outcomes included length of stay, costs, readmission rate and complications. Two reviewers independently assessed the methodological quality of the selected papers and recorded the findings with an evaluation tool developed from a set of items for quality assessment derived from the Cochrane Library and other publications. RESULTS: The study sample comprised of 115 publications. A total of 91.3% of the studies comprised of retrospective studies and 8.7% were randomized controlled studies. Using a quality-scoring assessment tool, 33% of the papers were classified as of good quality, whereas 67% were classified as of low quality. Of the studies, 10.4% controlled for confounding by matching and 59.1% adopted parametric statistical tests without testing variables on normal distribution. Differences in outcomes were not always statistically tested. CONCLUSION: Readers should be cautious when interpreting the results of clinical pathway evaluation studies because of the confounding factors and sources of contamination affecting the evidence-based validity of the outcomes.

The impact of a reduced dose of dexamethasone on glucose control after coronary artery bypass surgery.

BACKGROUND: Intensive insulin therapy to maintain normoglycemia after cardiac surgery reduces morbidity and mortality. We investigated the magnitude and duration of hyperglycemia caused by dexamethasone administered after cardiopulmonary bypass. METHODS: A single-center before-after cohort study was performed. All consecutive patients undergoing coronary artery bypass grafting with cardiopulmonary bypass during a 6-month period were included. Insulin administration was guided by a sliding scale protocol. Halfway the observation period, the dexamethasone protocol was changed. The single dose (1D) group received a pre-operative dose of dexamethasone of 1 mg/kg. The double dose group (2D) received an additional dose of 0.5 mg/kg of dexamethasone post-operatively at ICU admission. RESULTS: We included 116 patients in the 1D group and 158 patients in the 2D group. There were no significant baseline differences between the groups. Median Euroscore was 5. In univariable analysis, the glucose level was different between groups 1D and 2D at 4, 6, 9, 12 and 24 hours after ICU admission (all p < 0.001). Insulin infusion was higher in the 1D group. Corrected for insulin dose in multivariable linear analysis, the difference in glucose between the 1D and 2D groups was 1.5 mmol/L (95% confidence interval 1.0-2.0, p < 0.001) 12 hours after ICU admission. CONCLUSION: Dexamethasone exerts a hyperglycemic effect in cardiac surgery patients. Patients receiving high-dose corticosteroid therapy should be monitored and treated more intensively for hyperglycemic episodes.

Acute isovolemic hemodilution triggers proinflammatory and procoagulatory endothelial activation in vital organs: role of erythrocyte aggregation.

OBJECTIVES: The essential role of erythrocytes as oxygen carriers is historically well established, but their function to aggregate and the consequences on the microcirculation is under debate. The pathogenic potential of low erythrocyte aggregation could be important for patients undergoing on-pump cardipopulmonary bypass. These patients are severely hemodiluted due to preoperative isovolemic hemodilution (IHD), circuit priming, and large fluid infusions perioperatively. Considering the vascular endothelium sensitivity to variations in blood rheology, the authors hypothesize that low erythrocyte aggregation will be responsible for activation of vascular endothelium during acute IHD. METHODS: Acute IHD (30 mL/kg exchange transfusion with colloid solutions) was induced in an "aggregating species"(pigs, n = 15). The hypoxic oxidative stress (plasma malondialdehyde, ex vivo oxygen radicals production in heart, lung, kidney, liver, and ileum tissue biopsies), erythrocyte aggregation (LORCA), and endothelial activation (real-time quantitative RT-PCR on von Willebrand factor (vWF), E- and P-selectins, endothelial nitric oxide synthase gene-expression in tissue biopsies) were investigated. RESULTS: The production of superoxide and hydroxyl radicals, measured as H2O2 generation, was similar at all times in sham-operated and hemodiluted animals, proving a maintained oxygen delivery to tissues. Acute IHD was followed by a dramatic drop in erythrocyte aggregation and immediate prothrombotic (significant vWF mRNA upregulation in heart, lungs, kidney, liver, ileum) and proinflammatory (significant E- and P-selectins mRNA upregulation in lungs and ileum) endothelial activation. Low erythrocyte aggregation was significantly correlated with increased mRNA-expression of vWF (heart, liver, ileum) and P-selectin (lungs, ileum, and heart). CONCLUSIONS: These results suggest that low erythrocyte aggregation might trigger endothelium-dependent thrombogenic and proinflammatory response during acute isovolemic hemodilution.

Favorable long-term outcome of Maze surgery in patients with lone atrial fibrillation.

BACKGROUND: Rhythm control is indicated for patients suffering from symptomatic atrial fibrillation (AF), but remains difficult to establish. We investigated the long-term outcome of Cox maze III surgery in patients with symptomatic lone AF refractory to antiarrhythmic drug therapy. METHODS: Patients with a history of symptomatic paroxysmal or persistent AF refractory for at least two class I or III antiarrhythmic drugs and without structural heart disease or bradyarrhythmias were included. All patients underwent Cox maze III surgery. Complete success was defined as the absence of AF without antiarrhythmic drugs beyond 3 months after the procedure, and partial success as the absence of AF with antiarrhythmic drug use. RESULTS: A total of 29 patients were included (27 male), with a mean age of 48 +/- 6 years. At the time of surgery, 11 patients (38%) had persistent AF. After a mean follow-up of 4.8 +/- 2.4 years, 79% of patients had complete success, and 2 patients (7%) were free of AF with antiarrhythmic drugs. At the end of follow-up, left ventricular fractional shortening was significantly improved (from 31% +/- 10% to 39% +/- 8%, p = 0.002), left atrial size was unchanged, exercise capacity was within normal ranges, and quality of life was comparable with that of healthy controls. Severe complications included reoperations for postoperative bleeding (n = 3), pericardial effusion (n = 1), and mediastinitis (n = 1). In 2 patients, a pacemaker was implanted postoperatively because of sinus node dysfunction. CONCLUSIONS: Cox maze III surgery is a highly effective therapy for drug-refractory lone AF, and therefore remains an alternative to transvenous pulmonary vein ablation.