Volatile Anesthetics versus Total Intravenous Anesthesia for Cardiac Surgery.

BACKGROUND: Volatile (inhaled) anesthetic agents have cardioprotective effects, which might improve clinical outcomes in patients undergoing coronary-artery bypass grafting (CABG). METHODS: We conducted a pragmatic, multicenter, single-blind, controlled trial at 36 centers in 13 countries. Patients scheduled to undergo elective CABG were randomly assigned to an intraoperative anesthetic regimen that included a volatile anesthetic (desflurane, isoflurane, or sevoflurane) or to total intravenous anesthesia. The primary outcome was death from any cause at 1 year. RESULTS: A total of 5400 patients were randomly assigned: 2709 to the volatile anesthetics group and 2691 to the total intravenous anesthesia group. On-pump CABG was performed in 64% of patients, with a mean duration of cardiopulmonary bypass of 79 minutes. The two groups were similar with respect to demographic and clinical characteristics at baseline, the duration of cardiopulmonary bypass, and the number of grafts. At the time of the second interim analysis, the data and safety monitoring board advised that the trial should be stopped for futility. No significant difference between the groups with respect to deaths from any cause was seen at 1 year (2.8% in the volatile anesthetics group and 3.0% in the total intravenous anesthesia group; relative risk, 0.94; 95% confidence interval [CI], 0.69 to 1.29; P = 0.71), with data available for 5353 patients (99.1%), or at 30 days (1.4% and 1.3%, respectively; relative risk, 1.11; 95% CI, 0.70 to 1.76), with data available for 5398 patients (99.9%). There were no significant differences between the groups in any of the secondary outcomes or in the incidence of prespecified adverse events, including myocardial infarction. CONCLUSIONS: Among patients undergoing elective CABG, anesthesia with a volatile agent did not result in significantly fewer deaths at 1 year than total intravenous anesthesia. (Funded by the Italian Ministry of Health; MYRIAD ClinicalTrials.gov number, NCT02105610.).

Intracardiac hematoma treated conservatively by ECMO support.

Clinical pathway of an intracardiac hematoma treated by ECMO support.

Esmolol in Cardiac Surgery: A Randomized Controlled Trial.

OBJECTIVE: To assess whether the administration of the ultra-short-acting ß-blocker esmolol in cardiac surgery could have a cardioprotective effect that translates into improved postoperative outcomes. DESIGN: Single-center, double-blinded, parallel-group randomized controlled trial. SETTING: A tertiary care referral center. PARTICIPANTS: Patients undergoing elective cardiac surgery with preoperative evidence of left ventricular end-diastolic diameter >60 mm and/or left ventricular ejection fraction <50%. INTERVENTIONS: Patients were assigned randomly to receive either esmolol (1 mg/kg as a bolus before aortic cross-clamping and 2 mg/kg mixed in the cardioplegia solution) or placebo in a 1:1 allocation ratio. MEASUREMENTS AND MAIN RESULTS: The primary composite endpoint of prolonged intensive care unit stay and/or in-hospital mortality occurred in 36/98 patients (36%) in the placebo group versus 27/102 patients (27%) in the esmolol group (p = 0.13). In the esmolol group, a reduction in the maximum inotropic score during the first 24 postoperative hours was observed (10 [interquartile range 5-15] v 7 [interquartile range 5-10.5]; p = 0.04), as well as a trend toward a reduction in postoperative low-cardiac-output syndrome (13/98 v 6/102; p = 0.08) and the rate of hospital admission at one year (26/95 v 16/96; p = 0.08). A trend toward an increase in the number of patients with ejection fraction ≥60% at hospital discharge also was observed (4/95 v 11/92; p = 0.06). CONCLUSIONS: In the present trial, esmolol as a cardioplegia adjuvant enhanced postoperative cardiac performance but did not reduce a composite endpoint of prolonged intensive care unit stay and/or mortality.

Risk Factors and Impact on Clinical Outcome of Multidrug-Resistant Acinetobacter Baumannii Acquisition in Cardiac Surgery Patients.

OBJECTIVES: Acinetobacter baumannii recently has emerged as an important nosocomial pathogen. The aim of this study was to assess the impact on mortality of multidrug-resistant A. baumannii (MDR-AB) infection/colonization in patients undergoing cardiac surgery and to investigate microbiologic characteristics, epidemiologic spread of this pathogen, and the relative containment measures. DESIGN: Single-center, retrospective cohort study of prospectively collected data. SETTING: Cardiac surgery tertiary-care center. PARTICIPANTS: Patients with positive MDR-AB cultures from September 1, 2009 to December 31, 2011. INTERVENTIONS: Bivariate and multivariate analyses were performed to individualize the risk factors for MDR-AB-infections in cardiac surgery patients. To evaluate the MDR-AB attributable mortality, a retrospective matched cohort study was performed. Incidence density ratio (IDR) was calculated to compare the MDR-AB infection/colonization before and after the introduction of preventive measures adopted following the first cases. MEASUREMENTS AND MAIN RESULTS: MDR-AB acquisition occurred in 14 patients (0,6%) of 2385 patients. At the multivariate analyses, preoperative use of inotropic drugs (OR 18.2, 95% CI 4.6-71.9) and logistic EuroSCORE (OR 1.09, 95% CI 1.06-1.13) were found as independent risk factors. Patients with MDR-AB had 57% cumulative in-hospital mortality; no statistical differences in mortality were observed in the matched group. IDR revealed a significantly decreased incidence of infection/colonization (0.3 per 1,000 days of stay compared with 0.03/1,000 days of stay, p = 0.0001) after the containment measures became effective. CONCLUSIONS: Sicker patients are more susceptible to be infected by A. baumannii, but mortality is not significantly higher compared with other patients with similar characteristics. Adequate measures are fundamental to control the spread of the infection.

Allogenic blood transfusion in cardiac surgery.

Blood transfusion carries benefits and risks. Adult cardiac surgery accounts for a significant proportion of all red blood cells transfusions. However, the identification of the patient, who will truly benefit from transfusions, is still controversial. This review provides an overview on allogenic blood transfusions in adult cardiac surgery.

Impella 5.0 support before, during, and after surgical ventriculoplasty following acute myocardial infarction in the COVID-19 era: a case report.

BACKGROUND: Left ventricular (LV) aneurysms complicate anterior myocardial infarctions (MIs) in 8-15% of cases. In case of associated LV dysfunction, rapidly evolving heart failure may follow, and urgent surgery becomes life-saving. CASE SUMMARY: Following an acute anterior MI treated by percutaneous coronary intervention, which resulted in apical hypokinesis, depressed LV function, and moderate mitral regurgitation, a 70-year-old male patient kept in contact with our cardiology department through phone calls. Over 6 weeks, the patient's conditions worsened. For fear of contracting COVID-19, he refused to attend to the Emergency Room. Conditions did not improve despite medical therapy adjustments, and he was admitted to hospital following a syncope. Computed tomography scan revealed pneumonia, and he was placed in a 'grey' ward while waiting for nose-swab results for COVID-19. A rapid escalation of treatment was necessary as conditions did not improve with low-dose inotropes, and he required invasive ventilation. An Impella 5.0 was implanted as support prior to surgery, was maintained during the procedure and as a means of weaning off extracorporeal circulation. Surgery was successful and Impella 5.0 was removed on postoperative Day 5. DISCUSSION: To date, Impella use in cardiothoracic surgery has been described in case of ventricular septal rupture or as a bridge to permanent LV assist device. In our case, Impella 5.0 was implanted, used as a bridge to surgery, and as postoperative support in a patient with evolving cardiogenic shock due to LV aneurysm and depressed LV ejection fraction following acute MI, in the difficult setting of the COVID-19 pandemic.

N-terminal B-natriuretic Peptide after coronary artery bypass graft surgery.

OBJECTIVE: To investigate N-terminal amino-acid sequence of the B-natriuretic peptide (NT-proBNP) release and its prognostic characteristics after coronary artery bypass graft surgery with and without cardiopulmonary bypass. DESIGN: Observational study. SETTING: Teaching hospital. PARTICIPANTS: One hundred eighty-four patients. INTERVENTIONS: The authors determined plasma concentrations of NT-proBNP just before anesthesia induction and 24 hours after the end of the surgery. MEASUREMENTS AND MAIN RESULTS: NT-proBNP concentrations (median [interquartile range]) increased from 270 (75-716) pg/mL preoperatively to 1,664 (978-3,193) pg/mL on postoperative day 1 (p < 0.001), and all postoperative values were higher than the preoperative ones. NT-proBNP concentrations at day 1 were correlated to those at day 0 (r(2) = 0.34, p < 0.001). Patients showing elevated concentration of cTnI at day 1 (>14 ng/mL) had significantly (p = 0.04) higher plasma NT-proBNP levels than patients with a low cardiac troponin I concentration. Patients with prolonged intensive care unit (ICU) stay (>4 days) showed at day 1 significantly higher (p = 0.003) plasma NT-proBNP levels than patients with ICU stay <4 days. Elevated NT-proBNP at day 1 was significantly (p = 0.001) associated with in-hospital mortality, 18,584 (11,896-29,158) pg/mL versus 1,597 (965-3,034) pg/mL in survivors. CONCLUSIONS: The present results show, for the first time, that postoperative NT-proBNP levels are associated with in-hospital mortality and prolonged ICU stay after CABG surgery. These findings support the prognostic value of postoperative plasma levels of NT-proBNP.

Esmolol reduces perioperative ischemia in cardiac surgery: a meta-analysis of randomized controlled studies.

OBJECTIVE: beta-Blockers were associated with a reduction of mortality and morbidity in noncardiac surgery until recently when the POISE trial showed that beta-blockers could be harmful in the perioperative period because of hypotension and bradycardia. Esmolol is an ultra-short-acting beta-blocker mostly used in emergency and high-risk patients. The authors performed a meta-analysis to evaluate the clinical effects of esmolol in cardiac surgery. DESIGN: Meta-analysis. SETTING: Hospitals. PARTICIPANTS: A total of 778 patients from 20 randomized trials. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULT: Three investigators independently searched BioMedCentral and PubMed. Inclusion criteria were random allocation to treatment and comparison of esmolol versus other drugs, placebo, or standard of care in cardiac surgery. Exclusion criteria were duplicate publications, nonhuman experimental studies, and no data on clinical outcomes. The use of esmolol was associated with a significant reduction of myocardial ischemia episodes (15/122 [12.2%] in the esmolol group v 36/140 [25.7%] in the control arm, odds ratio [OR] =0.42 [0.23-0.79], p = 0.007) and development of arrhythmias after cardiopulmonary bypass (15/65 [23.07%] v 23/64 [35.9%], OR = 0.42 [0.18-1.01], p = 0.05). The authors did not find a reduction in the use of inotropic drugs in esmolol-treated patients (29/153 [18.9%] v 48/146 [32.8%], OR = 0.43 [0.16-1.10], p = 0.08). Esmolol-treated patients had more episodes of bradycardia (19/129 [14.72%] v 3/133 [2.25%], OR = 5.49 [2.21-13.62], p = 0.0002) and hypotension (28/113 [24.77%] v 14/119 [11.76%], OR = 2.73 [0.83-9.04], p = 0.10). CONCLUSIONS: Esmolol reduces the incidence of myocardial ischemia and arrhythmias in cardiac surgery. An increase in bradycardia was noted as well.

Epidural anesthesia in elderly patients undergoing coronary artery bypass graft surgery.

OBJECTIVES: The purpose of this study was to evaluate the effects of thoracic epidural anesthesia on postoperative N-terminal pro B-natriuretic peptide (NT-proBNP) release in elderly patients undergoing elective coronary artery bypass graft (CABG) surgery. DESIGN: A case-matched, nonrandomized study. SETTING: A university hospital, single institution. PARTICIPANTS: 46 consecutive and 46 control patients. INTERVENTIONS: Ninety-two elderly patients (>65 years old) undergoing elective CABG surgery were recruited. Forty-six patients receiving general and epidural anesthesia were case matched (preoperative medications, ejection fraction, and comorbidities) with 46 control subjects receiving general anesthesia. The primary outcome measure was postoperative NT-proBNP release. The preoperative or intraoperative variables significantly associated with an intensive care unit stay longer than 4 days were determined by logistic regression. MEASUREMENTS AND MAIN RESULTS: The median (interquartile range) plasma concentrations of NT-proBNP before surgery were 402 (115-887 pg/mL) in the epidural group versus 508 (228-1,285 pg/mL) in the general anesthesia group (p = 0.9), whereas 24 hours after surgery it increased to 1846 (1,135-3,687 pg/mL) versus 5,005 (2,220-11,377 pg/mL) (p = 0.001), respectively. There were more patients (p = 0.043) in the control group (9/46 = 19.5%) than in the thoracic epidural anesthesia group (4/46 = 8.8%) with an intensive care unit stay longer than 4 days. The absence of preoperative beta-blocker therapy (odds ratio = 3.94; 95% confidence interval, 1.123-13.833; p =0.03) and of an epidural catheter (odds ratio = 3.91; 95% confidence interval, 1.068-14.619; p = 0.04) were the only preoperative and intraoperative variables independently associated with a prolonged intensive care unit stay. CONCLUSIONS: Epidural anesthesia added to general anesthesia for CABG surgery significantly attenuates NT-proBNP release in elderly patients and reduces the incidence of prolonged intensive care unit stay.

Desmopressin reduces transfusion needs after surgery: a meta-analysis of randomized clinical trials.

BACKGROUND: Perioperative pathologic microvascular bleeding is associated with increased morbidity and mortality and could be reduced by hemostatic drugs. At the same time, safety concerns regarding existing hemostatic agents include excess mortality. Numerous trials investigating desmopressin have lacked power to detect a beneficial effect on transfusion of blood products. The authors performed a meta-analysis of 38 randomized, placebo-controlled trials (2,488 patients) investigating desmopressin in surgery and indicating at least perioperative blood loss or transfusion of blood products. METHODS: Pertinent studies were searched in BioMed Central, CENTRAL, and PubMed (updated May 1, 2008). Further hand or computerized searches involved recent (2003-2008) conference proceedings. RESULTS: In most of the included studies, 0.3 microg/kg desmopressin was used prophylactically over a 15- to 30-min period. In comparison with placebo, desmopressin was associated with reduced requirements of blood product transfusion (standardized mean difference = -0.29 [-0.52 to -0.06] units per patient; P = 0.01), which were more pronounced in the subgroup of noncardiac surgery and were without a statistically significant increase in thromboembolic adverse events (57/1,002 = 5.7% in the desmopressin group vs. 45/979 = 4.6% in the placebo group; P = 0.3). CONCLUSIONS: Desmopressin slightly reduced blood loss (almost 80 ml per patient) and transfusion requirements (almost 0.3 units per patient) in surgical patients, without reduction in the proportion of patients who received transfusions. This meta-analysis suggests the importance of further large, randomized controlled studies using desmopressin in patients with or at risk of perioperative pathologic microvascular bleeding.

MortalitY in caRdIAc surgery (MYRIAD): A randomizeD controlled trial of volatile anesthetics. Rationale and design.

OBJECTIVE: There is initial evidence that the use of volatile anesthetics can reduce the postoperative release of cardiac troponin I, the need for inotropic support, and the number of patients requiring prolonged hospitalization following coronary artery bypass graft (CABG) surgery. Nevertheless, small randomized controlled trials have failed to demonstrate a survival advantage. Thus, whether volatile anesthetics improve the postoperative outcome of cardiac surgical patients remains uncertain. An adequately powered randomized controlled trial appears desirable. DESIGN: Single blinded, international, multicenter randomized controlled trial with 1:1 allocation ratio. SETTING: Tertiary and University hospitals. INTERVENTIONS: Patients (n=10,600) undergoing coronary artery bypass graft will be randomized to receive either volatile anesthetic as part of the anesthetic plan, or total intravenous anesthesia. MEASUREMENTS AND MAIN RESULTS: The primary end point of the study will be one-year mortality (any cause). Secondary endpoints will be 30-day mortality; 30-day death or non-fatal myocardial infarction (composite endpoint); cardiac mortality at 30day and at one year; incidence of hospital re-admission during the one year follow-up period and duration of intensive care unit, and hospital stay. The sample size is based on the hypothesis that volatile anesthetics will reduce 1-year unadjusted mortality from 3% to 2%, using a two-sided alpha error of 0.05, and a power of 0.9. CONCLUSIONS: The trial will determine whether the simple intervention of adding a volatile anesthetic, an intervention that can be implemented by all anesthesiologists, can improve one-year survival in patients undergoing coronary artery bypass graft surgery.

Renoprotective action of fenoldopam in high-risk patients undergoing cardiac surgery: a prospective, double-blind, randomized clinical trial.

BACKGROUND: Acute renal failure is a serious complication of cardiac surgery causing high morbidity and mortality. The aim of this study was to evaluate the usefulness of fenoldopam, a specific agonist of the dopamine-1 receptor, in patients at high risk of perioperative renal dysfunction. METHODS AND RESULTS: A prospective single-center, randomized, double-blind trial was performed after local ethical committee approval and after written consent was obtained from 80 patients undergoing cardiac surgery. Patients received either fenoldopam at 0.05 microg/kg per minute or dopamine at 2.5 microg/kg per minute after the induction of anesthesia for a 24-hour period. All these patients were at high risk of perioperative renal dysfunction as indicated by Continuous Improvement in Cardiac Surgery Program score >10. Primary end point was defined as 25% creatinine increase from baseline levels after cardiac surgery. The 2 groups (fenoldopam versus dopamine) were homogeneous cohorts, and no difference in outcome was observed. Acute renal failure was similar: 17 of 40 (42.5%) in the fenoldopam group and 16 of 40 (40%) in the dopamine group (P=0.9). Peak postoperative serum creatinine level, intensive care unit and hospital stay, and mortality were also similar in the 2 groups. CONCLUSIONS: Despite an increasing number of reports of renal protective properties from fenoldopam, we observed no difference in the clinical outcome compared with dopamine in a high-risk population undergoing cardiac surgery.

Prevention of atrial fibrillation and inflammatory response after on-pump coronary artery bypass using different statin dosages: a randomized, controlled trial.

BACKGROUND: This randomized controlled trial aimed to evaluate the effects of seven-day preoperative treatment with two different dosages of atorvastatin on the incidence of postoperative atrial fibrillation (POAF) and release of inflammatory markers such as high-sensitive C-reactive protein (hsCRP) and interleukin-6 in patients undergoing elective first-time on-pump coronary artery bypass grafting (CABG). METHODS: The cohort study comprised 212 consecutive patients, already taking statins, who underwent elective first-time CABG with cardiopulmonary bypass without history of atrial fibrillation (AF). Patients were randomly divided into two groups: those who received atorvastatin 40 mg (TOR40 group, 111 patients) and those who received 80 mg (TOR80 group, 101 patients) once a day for 7 days before the planned operation. The primary endpoint was the incidence of AF. The secondary endpoints were the postoperative variations of inflammatory markers, hospital length of stay, and the incidence of major adverse cardiac and clinical events. RESULTS: A total of 26 patients (23.6 %) pretreated with atorvastatin 40 mg and 16 (15.8 %) patients pretreated with atorvastatin 80 mg had postoperative AF but the difference did not reach the statistical significance (p = 0.157). Median values of interleukin-6 and hsCRP at 12 and 24 h did not have differences between the two groups. No statistically significant differences in the other secondary endpoints were detected. CONCLUSIONS: According to our result, 7-day preoperative treatment with a high dose of atorvastatin is associated with a trend to a decrease in the incidence of POAF compared with treatment at a lower dose, although it does not impact on the level of inflammatory markers. CLINICAL TRIAL REGISTRATION: European Clinical Trials Database (EudraCT: 2006-005757-30).

Mortality, morbidity, and quality of life after circumferential pulmonary vein ablation for atrial fibrillation: outcomes from a controlled nonrandomized long-term study.

OBJECTIVES: This study was designed to investigate the potential of circumferential pulmonary vein (PV) ablation for atrial fibrillation (AF) to maintain sinus rhythm (SR) over time, thus reducing mortality and morbidity while enhancing quality of life (QoL). BACKGROUND: Circumferential PV ablation is safe and effective, but the long-term outcomes and its impact on QoL have not been assessed or compared with those for medical therapy. METHODS: We examined the clinical course of 1,171 consecutive patients with symptomatic AF who were referred to us between January 1998 and March 2001. The 589 ablated patients were compared with the 582 who received antiarrhythmic medications for SR control. The QoL of 109 ablated and 102 medically treated patients was measured with the SF-36 survey. RESULTS: Median follow-up was 900 days (range 161 to 1,508 days). Kaplan-Meier analysis showed observed survival for ablated patients was longer than among patients treated medically (p < 0.001), and not different from that expected for healthy persons of the same gender and calendar year of birth (p = 0.55). Cox proportional-hazards model revealed in the ablation group hazard ratios of 0.46 (95% confidence interval [CI], 0.31 to 0.68; p < 0.001) for all-cause mortality, of 0.45 (95% CI, 0.31 to 0.64; p < 0.001) for morbidities mainly due to heart failure and ischemic cerebrovascular events, and of 0.30 (95% CI, 0.24 to 0.37; p < 0.001) for AF recurrence. Ablated patients' QoL, different from patients treated medically, reached normative levels at six months and remained unchanged at one year. CONCLUSIONS: Pulmonary vein ablation improves mortality, morbidity, and QoL as compared with medical therapy. Our findings pave the way for randomized trials to prospect a wider application of ablation therapy for AF.

'Early' and 'late' timing for renal replacement therapy in acute kidney injury after cardiac surgery: a prospective, interventional, controlled, single-centre trial.

OBJECTIVES: Acute kidney injury after cardiac surgery (CS-AKI) is strongly associated with in-hospital mortality and morbidity. We aimed to investigate whether 'early' or 'late' initiation of renal replacement therapy (RRT) in patients with CS-AKI is associated with a survival benefit or more favourable outcomes. METHODS: All patients who had undergone cardiac surgery at 'Ospedali Riuniti' of Ancona from July 2011 to February 2013 were prospectively enrolled and divided into two treatment groups: the 'early' approach was used during the first 10 months, and the 'late' approach during the next 10 months. 'Early' RRT was started after 6 h of urine output less than 0.5 ml/kg/h, whereas in the 'late' group, therapy started on the basis of persistent (>12 h) oliguria. A total of 1658 patients were enrolled in the trial. The primary outcome was operative mortality, and the secondary outcomes were length of intensive care unit and hospital stay. RESULTS: The total number of patients treated with RRT was 59 (3.6%): 46 (5.5%) in the 'early' group and 13 (1.6%) in the 'late' group (P < 0.0001). Although RRT was significantly less utilized in the 'late' group, no significant difference in the primary and secondary outcomes was found, but a trend towards a better outcome in the 'late' group was observed. Furthermore, we found a significant difference in mortality between the two approaches in the subgroups of patients with preoperative renal dysfunction and in patients suffering from CS-AKI with a clear advantage of the late strategy. CONCLUSIONS: Our results do not support the use of early RRT in CS-AKI. CLINICAL TRIAL REGISTRATION: This trial is registered in the clinicaltrial.gov registry: NCT01961999.

Comparison between repaglinide and glimepiride in patients with type 2 diabetes mellitus: a one-year, randomized, double-blind assessment of metabolic parameters and cardiovascular risk factors.

BACKGROUND: Repaglinide and glimepiride are relatively new oral hypoglycemic agents. Few data are available concerning their effects on metabolic parameters other than measures of glycemic control. OBJECTIVES: In addition to assessing the effects of repaglinide and glimepiride on glycemic control in patients with type 2 diabetes mellitus, this study also examined the effects of these agents on 3 metabolic parameters known to be cardiovascular risk factors--lipoprotein(a) (Lp[a]), plasminogen activator inhibitor-1 (PAI-1), and homocysteine (Hcy). METHODS: This randomized, placebo-controlled, double-blind trial was conducted at a single center in Italy. Eligible patients were nonsmokers; had no hypertension or coronary heart disease; were taking no hypolipidemic drugs, diuretics, beta-blockers, or thyroxin; and had normal renal function. After an initial 4-week placebo washout period, patients were randomized to receive repaglinide 1 mg/d or glimepiride 1 mg/d. The dose of study drug was optimized over an 8-week titration period, which was followed by a 12-month treatment period. Measures of glycemic control (glycated hemoglobin [HbA1c], fasting plasma glucose [FPG], postprandial plasma glucose [PPG], fasting plasma insulin [FPI], postprandial plasma insulin [PPI]) and the other metabolic parameters of interest were assessed after 6 and 12 months of treatment. RESULTS: One hundred twenty-four patients (63 women, 61 men) completed the study, 62 in each treatment group. There were no significant differences in demographic characteristics between groups. After 6 and 12 months of treatment, FPG levels and HbA1c values were significantly reduced from baseline in both groups (6 months, P < 0.05; 12 months, P < 0.01). After 6 months, PPG levels were significantly decreased only in the repaglinide group (P < 0.05 vs baseline); at 12 months, however, PPG levels were significantly reduced from baseline in both groups (P < 0.01 repaglinide, P < 0.05 glimepiride). No significant changes from baseline in FPI or PPI levels were seen in either group at 6 months, although FPI levels were significantly increased in the repaglinide group at 12 months (P < 0.05). Repaglinide significantly lowered levels of Lp(a), PAI-1, and Hcy after 12 months (all, P < 0.05 vs baseline). Glimepiride significantly lowered levels of Lp(a) and Hcy after 6 months (both, P < 0.05 vs baseline) and levels of Lp(a) (P < 0.01 vs baseline), Hcy (P < 0.01 vs baseline), and PAI-1 (P < 0.05 vs baseline) after 12 months. CONCLUSIONS: Repaglinide and glimepiride improved glycemic control and reduced levels of other metabolic parameters of interest in this population of patients with type 2 diabetes. It is possible that the reductions in Lp(a), PAI-1, and Hcy were the result of improved glucose metabolism; however, the possibility that repaglinide and glimepiride may have a direct effect on these parameters should not be excluded.

Comparison of glycaemic control and cardiovascular risk profile in patients with type 2 diabetes during treatment with either repaglinide or metformin.

OBJECTIVE: To compare glycaemic control and cardiovascular risk profile in patients with type 2 diabetes following 12 months' treatment with either repaglinide or metformin. STUDY DESIGN AND METHODS: This was an open uncontrolled randomised study in n=112 patients with inadequately controlled type 2 diabetes not previously treated with oral hypoglycaemic agents. Patients beginning treatment with either repaglinide or metformin entered an 8-week titration period (to optimise dosage: repaglinide, 2-4 mg/day; metformin, 1500-2500 mg/day) followed by a 12-month treatment period. Glycaemic control and cardiovascular risk factors were determined at baseline and at the end of the treatment period. RESULTS: Mean (S.D.) final drug doses were 3 (+/-1) mg/day in the repaglinide group and 2000 (+/-500) mg/day in the metformin group. Significant improvements in glycaemic control [glycated haemoglobin, fasting and 2-h postprandial plasma glucose (PPG)] were demonstrated in both treatment groups. The decrease in PPG was significantly greater in the repaglinide group (P<0.05). During the treatment period, fasting plasma insulin (FPI) decreased significantly in both groups, more so with metformin (P<0.05). Two-hour postprandial plasma insulin (PPI) levels decreased only in the metformin group (P<0.05). Significant improvements between baseline and final visit were demonstrated in one or both groups in the following cardiovascular risk factors: total cholesterol, low-density lipoprotein cholesterol (LDL-C), triglycerides, plasminogen activator inhibitor, lipoprotein(a) and homocysteine. No changes were observed in high-density lipoprotein cholesterol (HDL-C), apolipoprotein A-I, apolipoprotein B, fibrinogen, body mass index (BMI) or blood pressure. CONCLUSIONS: The use of repaglinide or metformin in drug therapy-nai;ve patients with type 2 diabetes over a 12-month period is associated with improvements in both glycaemic control and cardiovascular risk profile. The latter cannot necessarily be attributed to the pharmacotherapy per se, but provides reassurance in the context of initiating oral hypoglycaemic drug therapy with these agents.

Clinical significance of a new Q wave after cardiac surgery.

OBJECTIVE: The appearance of new Q waves on the electrocardiogram (ECG) after cardiac surgery has been traditionally considered a sign of major myocardial tissue damage. The aim of this study was to investigate the clinical significance of new Q waves appearing following cardiac surgery and to correlate them with the release of myocardial cell damage biomarkers. METHODS: 206 consecutive patients undergoing cardiac surgery were prospectively evaluated. A 12 lead ECG was recorded and cardiac troponin I and creatinekinase subfraction MB assayed the day before surgery, on arrival at the intensive care Unit. 4 and 18 h postoperatively and every morning until the fifth postoperative day. RESULTS: The incidence of new Q waves was 7.3%. Patients with isolated ECG findings had an uneventful postoperative course; on the contrary, when ECG changes were coupled with the release of myocardial necrosis biomarkers, patients had a complicated postoperative course. CONCLUSIONS: The association of a new Q wave and high levels of myocardial necrosis biomarkers is strongly associated with postoperative cardiac events. On the contrary, the isolated appearance of a new Q wave has no impact on the postoperative cardiac outcome.

Validation of a decision-making strategy for systolic anterior motion following mitral valve repair.

Low cardiac output syndrome and hypotension are dreadful consequences of systolic anterior motion (SAM) after a mitral valve (MV) repair. The management of SAM in the operating room remains controversial. We validate a recently suggested two-step management method and classification of this complication. This was a teaching hospital-based observational study. We validated a novel two-step conservative management method, consisting in intravascular volume expansion and discontinuation of inotropic drugs (step 1), and increasing the afterload by ascending aorta manual compression while administering esmolol e.v. (step 2). We also validate a novel classification of SAM: easy-to-revert (responding to step 1), difficult-to-revert (responding to step 2), or persistent. Fifty patients had an easy-to-revert while 26 had a difficult-to-revert SAM; 4 patients had a persistent condition (promptly diagnosed through our decisional algorithm) and underwent an immediate second pump run to repeat the mitral repair surgery. We confirmed that SAM after a repair of a degenerative MV is common and validated a simple two-step conservative management method that allows to clearly identify those few patients who require immediate surgical revision.