Impact of aortic valve replacement in symptomatic low-risk patients with less than severe aortic stenosis.

OBJECTIVE: To evaluate whether transcatheter or surgical aortic valve replacement (TAVR or SAVR) affects clinical and haemodynamic outcomes in symptomatic patients with moderately-severe aortic stenosis (AS). METHODS: Echocardiographic evidence of severe AS for enrolment in the Evolut Low Risk trial was based on site-reported measurements. For this post hoc analysis, core laboratory measurements identified patients with symptomatic moderately-severe AS (1.0

Low-Dose vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial.

BACKGROUND: Current guidelines recommend a target international normalized ratio (INR) range of 2.5 to 3.5 in patients with a mechanical mitral prosthesis. The Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) Mitral randomized controlled noninferiority trial assessed safety and efficacy of warfarin at doses lower than currently recommended in patients with an On-X (Artivion, Inc) mechanical mitral valve. METHODS: After On-X mechanical mitral valve replacement, followed by at least 3 months of standard anticoagulation, 401 patients at 44 North American centers were randomized to low-dose warfarin (target INR, 2.0-2.5) or standard-dose warfarin (target INR, 2.5-3.5). All patients were prescribed aspirin, 81 mg daily, and encouraged to use home INR testing. The primary end point was the sum of the linearized rates of thromboembolism, valve thrombosis, and bleeding events. The design was based on an expected 7.3% event rate and 1.5% noninferiority margin. RESULTS: Mean patient follow-up was 4.1 years. Mean INR was 2.47 and 2.92 (P <.001) in the low-dose and standard-dose warfarin groups, respectively. Primary end point rates were 11.9% per patient-year in the low-dose group and 12.0% per patient-year in the standard-dose group (difference, -0.07%; 95% CI, -3.40% to 3.26%). The CI >1.5%, thus noninferiority was not achieved. Rates (percentage per patient-year) of the individual components of the primary end point were 2.3% vs 2.5% for thromboembolism, 0.5% vs 0.5% for valve thrombosis, and 9.13% vs 9.04% for bleeding. CONCLUSIONS: Compared with standard-dose warfarin, low-dose warfarin did not achieve noninferiority for the composite primary end point. (PROACT Clinicaltrials.gov number, NCT00291525).

Mechanisms of Death in Low-Risk Patients After Transcatheter or Surgical Aortic Valve Replacement.

BACKGROUND: Death in high- and intermediate-risk patients after self-expanding transcatheter (TAVR) and surgical aortic valve replacement (surgery) differed in mechanisms and timing. In both risk groups, 1-year all-cause mortality was lower in TAVR than in surgery patients. The differences in mechanism and timing of death in low-risk patients has not been studied. This report explores the mechanisms of death during 3 time periods; 0 to 30 days (early), 31 to 120 days (recovery), and 121 to 365 days (late). METHODS: We retrospectively examined the mechanisms and timing of death following TAVR or surgery in the randomized Evolut Low Risk Trial. Patients were enrolled between March 2016 and November 2018 from 86 designated TAVR centers. Mechanisms of death were categorized as due to technical reasons, failure to repair, complications linked to death, failure to recover or other. RESULTS: All-cause mortality at 1 year was 2.2% for TAVR and 2.8% for surgery, p = 0.44. Early deaths included 3 TAVR patients, all due to technical reasons, and 8 surgery patients (1 technical, 5 complications and 2 failed to recover). Recovery period deaths included 6 TAVR patients (4 complications, 1 failed to recover and 1 other), and 1 surgery patient from complications of valve endocarditis. Late period deaths included 6 TAVR patients and 9 surgery patients, primarily due to complications. CONCLUSIONS: In this low-risk study cohort, no patient died from failure to repair the valve; reduction in procedural complications in the TAVR and surgery groups remain opportunities for further improvement in outcomes. Clinical Trial Registrations (clinicaltrials.gov): NCT02701283 (Evolut Low Risk).

WITHDRAWN: Low-Dose Versus Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Controlled Trial.

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Safety-net hospitals versus non-safety centers and clinical outcomes after trans-catheter aortic valve replacement.

OBJECTIVE: To compare post-procedural outcomes of trans-catheter valve replacement (TAVR) among safety-net (SNH) and non-safety net hospitals (non-SNH). BACKGROUND: SNH treat a large population of un-insured and low income patients; prior studies report worse outcome at these centers. Results of TAVR at these centers is limited. METHODS: Adults undergoing TAVR at hospitals in the US participating in the National In-patient sample (NIS) database from January 2014 to December 2015 were included. A 1:1 propensity-matched cohort of patients operated at SNH and non-SNH institutions was analyzed, on the basis of 16 demographic and clinical co-variates. Main outcome was all-cause post-procedural mortality. Secondary outcomes included stroke, acute kidney injury and length of post-operative stay. RESULTS: Between 2014 and 2015, 41,410 patients (mean age 80 ± 0.11 years, 46% female) underwent TAVR at 731 centers; 6,996 (16.80%) procedures were performed at SNH comprising 135/731 (18.4%) of all centers performing TAVR. SNH patients were more likely to be female (49% vs. 46%, p < .001); admitted emergently (31% vs. 21%; p < .001; at the lowest quartile for household income (25% % vs. 20%; p < .001) and from minorities (Blacks 5.9% vs. 3.9%; Hispanic 7.2% vs. 3.2%).Adjusted logistic regression was performed on 6,995 propensity-matched patient pairs. Post-procedural mortality [OR 0.99(0.98-1.007); p = .43], stroke [OR 1.009(0.99-1.02); p = .08], acute kidney injury [OR 0.99(0.96-1.01); p = .5] and overall length of stay (6.9 ± 0.1 vs. 7.1 ± 0.2 days; p = .57) were comparable in both cohorts. CONCLUSION: Post-procedural outcomes after TAVR at SNH are comparable to national outcomes and wider adoption of TAVR at SNH may not adversely influence outcomes.

Stability After Initial Decline in Coronary Revascularization Rates in the United States.

BACKGROUND: It remains uncertain how advances in revascularization techniques, availability of new evidence, and updated guidelines have influenced the annual rates of coronary revascularization in the United States. METHODS: We used the Nationwide Inpatient Sample data from 2005 to 2014 with appropriate weighting to determine national procedural volumes. To present accurately overall percutaneous coronary intervention (PCI) rates, PCI with same-day discharge numbers per year were estimated from the available literature and added to annual PCI procedures performed. RESULTS: Annual PCI rate declined from 353 per 100,000 adults in 2005 to 277 per 100,000 adults in 2009 (P < .001) but remained stable thereafter (P = .50). Annual coronary artery bypass grafting (CABG) rate declined steadily, at a shallower slope than PCI, from 120 per 100,000 in 2005 to 93 per 100,000 in 2009 (P = .02) but remained stable thereafter (P = .60). Similar trends were seen in men and women. Both PCI and CABG rates were lower in women than men over the study period (PCI, 482 to 324/100,000 in men vs 232 to 153/100,000 in women; CABG, 172 to 118/100,000 in men vs 64 to 38/100,000 in women). Annual PCI rates were higher than CABG rates in patients of all age groups including in younger patients (age < 50) and octogenarians. The proportion of coronary revascularization procedures performed per insurance type remained relatively similar across the study period. CONCLUSIONS: Annual rates of coronary revascularization have changed significantly over time, potentially because of advances in revascularization techniques, availability of new evidence, and updated guidelines. Rates of PCI declined more steeply than CABG before plateauing but remained higher than rates of CABG across the study period.

Feasibility and Safety of Adopting Next-Day Discharge as First-Line Option After Transfemoral Transcatheter Aortic Valve Replacement.

OBJECTIVES: Data on next-day discharge (NDD) after transcatheter aortic valve replacement (TAVR) are limited. This study investigated the feasibility and safety of NDD as a first-line option (the very-early discharge [VED] strategy) compared with the early-discharge (ED) strategy (2-3 days as a first-line option) after TAVR. METHODS: We reviewed 611 consecutive patients who had minimalist TAVR (transfemoral approach under conscious sedation) and no in-hospital mortality; a total of 418 patients underwent ED strategy (since December 2013) and 193 patients underwent VED strategy (as part of a hospital initiative to reduce length of stay, since August 2016). NDD in the VED strategy was performed with heart team consensus in patients without significant complications. The primary outcome was a composite of 30-day all-cause mortality/rehospitalization. RESULTS: Sixty-five patients (33.7%) in the VED strategy and 10 patients (2.4%) in the ED strategy were discharged the next day (P<.001). NDD patients had received balloon-expandable (n = 30) or self-expanding valves (n = 45) and showed a similar primary outcome rate compared with non-NDD patients. After adjustment using propensity score matching (172 pairs), post-TAVR length of stay was significantly shorter in the VED group (3.2 ± 3.1 days) than in the ED group (3.5 ± 2.7 days; P<.01). The primary outcome did not differ between the two groups (7.0% vs 11.6%; P=.14), with comparable 30-day mortality rate (1.2% vs 2.3%; P=.68) and rehospitalization rate (5.8% vs 11.1%; P=.08). CONCLUSIONS: Utilization of NDD as a first-line option after minimalist TAVR is feasible and safe, and leads to further reduction in length of stay compared with an ED strategy.

Short-Term and Long-Term Outcomes of Patients Undergoing Urgent Transcatheter Aortic Valve Replacement Under a Minimalist Strategy.

OBJECTIVES: Urgent transcatheter aortic valve replacement (TAVR) is associated with worse short-term outcomes compared with elective TAVR; however, little is known about long-term outcomes or the safety of the minimalist strategy in this setting. This study investigated the short-term and long-term outcomes of urgent TAVR compared with elective TAVR under a minimalist strategy (transfemoral [TF] approach with conscious sedation and no transesophageal echocardiography guidance). METHODS: After excluding 2 emergent patients requiring immediate procedures, a total of 474 consecutive patients underwent elective TF-TAVR (396 patients; 83.6%) or urgent TF-TAVR (78 patients; 16.4%). Urgent TAVR was defined as a procedure performed in the same hospitalization in patients emergently admitted due to cardiac arrest, severe acute decompensated heart failure, acute coronary syndrome, or repeated syncopal episodes. RESULTS: A minimalist approach was used in 77 patients (98.7%) undergoing urgent TAVR and in 392 patients (99.0%) undergoing elective TAVR (P=.59). Urgent TAVR had similar procedure-related complications, such as stroke, myocardial infarction, bleeding or vascular complications, and in-hospital mortality compared with elective TAVR (mortality, 1.3% vs 0.8%; P=.51) with no intraprocedural cross-over from conscious sedation to general anesthesia. However, 30-day and 1-year survival rates were reduced in patients undergoing urgent TAVR. After adjustment with baseline and procedural factors, urgent TAVR remained significantly predictive of 1-year mortality (adjusted hazard ratio, 2.26; 95% confidence interval, 1.16-4.23; P=.01). CONCLUSIONS: Urgent minimalist TAVR can be safely performed with favorable in-hospital outcomes, while increased 30-day and 1-year mortality rates suggest the importance of appropriate diagnosis and timely treatment of severe aortic stenosis.

Impact of residual coronary atherosclerosis on transfemoral transcatheter aortic valve replacement.

OBJECTIVES: This study reports on the clinical effects of complete vs incompletely revascularized coronary artery disease on transcatheter aortic valve replacement (TAVR). BACKGROUND: There is a high prevalence of active coronary artery disease (CAD) in patients undergoing TAVR but preemptive revascularization remains controversial. METHODS: Patients were categorized into three cohorts: complete revascularization (CR), incomplete revascularization of a major epicardial artery (IR Major), and incomplete revascularization of a minor epicardial artery only (IR Minor). When feasible, SYNTAX scoring was performed for exploratory analysis. Analyses were performed using Cox proportional hazard models and Kaplan-Meier method. RESULTS: A total of 323 patients with active CAD were included. Adjusted outcomes showed that patients with IR Major had increased incidence of acute myocardial infarction (AMI) or revascularization compared with those in the CR cohort (HR 3.72, P = 0.048). No difference was noted in all-cause mortality or all-cause readmission rates. Exploratory secondary analysis with residual SYNTAX scores showed a significant interaction between disease burden and AMI/revascularization, as well as all-cause readmission. All-cause mortality remained unaffected based on residual SYNTAX scores. CONCLUSIONS: This is a retrospective single-center study reporting on pre-TAVR revascularization outcomes in patients with active CAD. In this analysis, we found that patients undergoing TAVR benefited from achieving complete revascularization to abate future incidence of AMI/revascularization. Despite this finding, all-cause mortality remained unaffected. Future efforts should focus on the role of functional assessment of the coronaries, as well as the long-term effects of complete revascularization in a larger patient cohort.

Risk Calculator to Predict 30-Day Readmission After Coronary Artery Bypass: A Strategic Decision Support Tool.

BACKGROUND: Re-admission is an important source of patient dissatisfaction and increased hospital costs. A simple calculator to determine the probability of re-admission may help guide patient dismissal planning. METHODS: Using the national readmissions database (NRD), we identified admissions for isolated primary coronary artery bypass (CABG) and stratified them according to 30-day readmission. Including pre, intra and postoperative variables, we prepared a logistic regression model to determine the probability for re-admission. The model was tested for reliability with boot-strapping and 10-fold cross-validation. RESULTS: From 135,699 procedures, 19,355 were readmitted at least once within 30days of dismissal. Patients who were readmitted were older (67±10 vs 65 ± 10 years, p<0.01), females (32% vs 24%; p<0.01) and had a higher Elixhauser comorbidity score (1.5±1.4 vs 1.1±1.2; p<0.01). Our final model (c- statistic=0.65) consisted of 16 pre and three postoperative factors. End-stage renal disease (OR 1.79 [1.57-2.04]) and length of stay>9days (OR 1.60 [1.52-1.68]) were most prominent indicators for readmission. Compared to Medicaid beneficiaries, those with private insurance (OR 0.62 [0.57-0.68]) and Medicare (OR 0.85 [0.79-0.92]) coverage were less likely to be readmitted. CONCLUSIONS: Our simple 30-days CABG readmission calculator can be used as a strategic tool to help reduce readmissions after coronary artery bypass surgery.

Minimally Invasive Approaches to Surgical Aortic Valve Replacement: A Meta-Analysis.

BACKGROUND: Limited data exist studying the outcomes of the 2 minimally invasive aortic valve replacement (AVR) strategies-mini-sternotomy (AVR-st) and right anterior thoracotomy (AVR-th). We conducted an indirect meta-analysis to compare the outcomes of these minimally invasive approaches with each other and with conventional AVR (cAVR). METHODS: We Searched Medline, PubMed, Embase, and Web of Science in December 2017 for studies comparing AVR-st, AVR-th, and cAVR. Clinical outcomes were compared between cohorts with inverse weighted random effects modeling. Endpoints studied included hospital mortality, stroke, atrial fibrillation, cardiopulmonary bypass (CPB) time, and length of stay. RESULTS: A total of 19 studies (>10,000 pooled patients) met the inclusion criteria. Mortality (p = 0.06) and stroke (p = 0.15) were comparable between minimally invasive and conventional AVR. CPB times were longer with AVR-th versus cAVR (12.4 minutes [range, 5 to 19]; p < 0.01). In the AVR-th cohort, CPB duration was weakly inversely related to study size (p = 0.06). Atrial fibrillation was much less after AVR-th (odds ratio 0.47 [0.35 to 0.63]; p < 0.001). Hospital stay was significantly lower after minimally invasive surgery (0.8 [0.4 to 1.3] days; p < 0.01). AVR-th patients were dismissed 2.1 (1.6 to 2.7) days earlier than cAVR patients. CONCLUSIONS: Minimally invasive approaches to AVR yield excellent outcomes in high-volume centers. They reduce hospital stay and incidence of postoperative atrial fibrillation, and therefore should be considered in patients undergoing AVR. The operative approach should be selected according to surgeon's technical expertise and what is best for specific patient profile, however.

A Systemic Review and Meta-Analysis of Sutureless Aortic Valve Replacement Versus Transcatheter Aortic Valve Implantation.

BACKGROUND: Sutureless aortic valve replacement (SU-AVR) and transcatheter aortic valve implantation (TAVI) are increasingly adopted methods to treat high-risk patients with severe aortic valve stenosis. We conducted a systematic review and meta-analysis to compare the clinical outcomes between these two recent methods to treat aortic valve disease. METHODS: We systematically searched multiple databases (January 2000 to October 2016) to identify original studies comparing clinical outcome between SU-AVR and TAVI. End points studied were early mortality, development of paravalvular leak, early stroke, bleeding events, and the need for pacemaker insertion. A random-effect inverse-variance weighted analysis was performed. Event rates were compared as odds ratio (OR) and 95% confidence interval (CI). RESULTS: The meta-analysis included seven observational studies comprising 617 SU-AVR and 621 TAVI patients. Early mortality was 2.5% and 5% in the SU-AVR and TAVI cohorts, respectively (OR, 0.52; 95% CI, 0.30 to 0.90; p = 0.02; I2 = 2%). Postprocedural significant paravalvular leak was much lower after SU-AVR (OR, 0.18l; 95% CI, 0.11 to 0.30; p < 0.0001). Postprocedural stroke (OR, 0.71; 95% CI, 0.24 to 2.08; p = 0.53) and the need for pacemaker insertion (OR, 0.884; 95% CI, 0.364 to 2.18; p = 0.7) were comparable between the two cohorts. CONCLUSIONS: Our meta-analysis of observational studies demonstrates that early mortality is lower after SU-AVR than after TAVI in selected patients. The rates of stroke and pacemaker implant are comparable between procedures; however, the incidence of paravalvular leak is higher after TAVI.

Relationship between intraoperative serum lactate and hemoglobin levels on postoperative renal function in patients undergoing elective cardiac surgery.

BACKGROUND AND AIM: We examined the relationship between serum lactate and hemoglobin levels on renal function and postoperative outcome in low-risk elective coronary artery bypass graft (CABG) patients. METHODS: Intraoperative hemoglobin and lactate levels were measured in elective isolated CABG patients. Patients with renal dysfunction (baseline creatinine>2 mg/dL) were excluded. Multivariate logistic regression was used to determine associations between lactate, hemoglobin, and acute kidney injury (AKI). RESULTS: A total of 375 patients met study requirements, and 56/375 (15%) developed AKI. Of the patients who developed AKI, 43/278 (15.5%) were males, 13/97 (13.4%) females, and 11/44 (25%) African-Americans. Bivariate analysis between AKI and non-AKI subgroups found significant differences in age, race, baseline estimated glomerular filtration rate, preoperative hemoglobin, peak serum lactate, initial hemoglobin, and nadir hemoglobin. A high peak Lactate level (odds ratio [OR] 1.44[1.15-1.82]), low hemoglobin (OR 0.69[0.49-0.96]), and African American race (OR 2.26[0.96-5.05]) were independently associated with acute kidney injury. A significant relationship between decreasing intraoperative hemoglobin and increasing intraoperative serum lactate levels was observed exclusively in patients who developed postoperative AKI. Serum creatinine levels peaked, on average, 48 h postoperatively in the AKI subset of patients. CONCLUSION: In this series, 15% of patients who underwent elective cardiopulmonary bypass developed transient acute renal dysfunction. High lactate levels and low hemoglobin levels during cardiopulmonary bypass were associated with an increased risk of kidney injury.

Meta-Analysis of Usefulness of Concomitant Mitral Valve Repair or Replacement for Moderate Ischemic Mitral Regurgitation With Coronary Artery Bypass Grafting.

Moderate ischemic mitral regurgitation (MR) is often present in patients undergoing coronary artery bypass grafting (CABG). However, the clinical benefit of repairing moderate MR during CABG is unproven. We searched multiple databases to identify original studies comparing isolated CABG versus combined CABG and MR surgery (mitral valve surgery with coronary artery bypass grafting [MVCABG]); survival (either early or midterm) was the primary end point. Risk ratio (RR) or standardize mean difference was selected as the effect estimates; survival was compared by pooling hazard ratios. All results are presented with 95% CIs; p <0.05 is statistically significant. Eleven studies (7 retrospective and 4 randomized controlled trials; 547 MVCABG and 900 CABG patients) were included in our meta-analysis. Concomitant mitral valve repair significantly prolonged surgical duration (p <0.01). Early mortality (MVCABG 6.9% and CABG 6%) was comparable (RR 1.3 [0.9 to 1.8]; p = 0.11). At follow-up, the MVCABG patients had similar New York Heart Association class (standardize mean difference -0.73 (-1.64 to 0.18; p = 0.11). However, patients who underwent concomitant mitral valve surgery had less MR at follow-up (recurrent significant MR, RR 0.37 [0.22 to 0.62]; p = 0.001; mean MR grade, mean difference = 0.39 [0.26 to 0.59]; p <0.001). Midterm survival rate (mean follow-up 5 years) was comparable in both groups (hazard ratio for mortality in the MVCABG cohort 1.1 [0.9 to 1.3]; p = 0.38). In conclusion, concomitant repair of moderate ischemic MR leads to improved mitral valve competence at follow-up; however, this was not translated into any functional or survival benefit for adding valve repair to CABG for these patients at 5 years of follow-up.

Tissue valves are preferable for patients with end-stage renal disease: an aggregate meta-analysis.

BACKGROUND: Valve selection in patients with end-stage renal disease (ESRD) is uncertain. We performed a systematic review and meta-analysis to compare clinical outcome in ESRD patients undergoing valve replacement. METHODS: We systematically searched multiple databases (2000-October 2015) to identify original studies comparing adverse events between mechanical and biological valve replacement in ESRD patients. End-points studied were: postoperative mortality, bleeding events, need for re-operation, and late survival. A random-effect inverse-variance weighted analysis was performed; event rates are compared as odds ratio (OR and 95% confidence interval) and hazard ratios (HR) for time-to-event data. Mechanical valve and tissue valve replacement were considered as study and control cohorts, respectively. RESULTS: Fifteen retrospective studies (5523 mechanical and 1600 tissue valve) were included in our meta-analysis. Early mortality was comparable (OR 1.15 [0.77; 1.72]; p = 0.49). The mean follow-up among studies ranged from 1.6-15 years. Bleeding was significantly higher after mechanical valve replacement (OR 2.55 [1.53; 4.26]; p = 0.0003). Structural valve degeneration was present in only 0.6% patients after a tissue valve replacement. Overall survival after valve replacement was poor (median 2.61 years); valve choice did not influence this outcome (pooled HR 0.87 [0.73; 1.04]; p = 0.14). CONCLUSION: Operative mortality in ESRD patients is comparable between mechanical and tissue valve replacement. Major bleeding episodes are significantly higher after mechanical valve replacement but structural degeneration in tissue valves during the follow-up period is low. Based on the findings from this meta-analysis, we would recommend using tissue valves in patients with ESRD.

N-Acetyl Cysteine Therapy Does Not Prevent Renal Failure in High-Risk Patients Undergoing Open-Heart Surgery.

BACKGROUND: Renal dysfunction is a common complication after cardiovascular surgery. Controversial issues have been discussed regarding the role of N-acetyl cysteine in the prevention of postoperative renal dysfunction. The purpose of this meta-analysis is to assess whether N-acetyl cysteine offers any protection against the development of acute renal dysfunction after cardiac surgery. METHODS: Multiple databases were searched for randomized trials comparing the role of N-acetyl cysteine and placebo in human patients undergoing cardiac surgery. End-points studied were: the incidence of acute renal failure, hemodialysis, early mortality, duration of hospital stay, and maximal change in creatinine values. Dichotomous variables were compared using the risk difference (RD) calculated with inverse weighting; continuous data was pooled as (standardized) mean difference. Results are presented with 95% confidence interval (P < .05 is significant); results are presented within 95% confidence interval. RESULTS: Thirteen randomized trials (713 and 707 patients in the N-acetyl cysteine and control groups, respectively) were included in the present analysis; nine dealing with patients at high-risk for acute renal failure. The incidence of postoperative acute renal dysfunction was 23% and 36% in the N-acetyl cysteine and control cohorts, respectively. N-acetyl cysteine therapy did not reduce acute renal dysfunction in the high-risk cohort [RD -0.03 (-0.09 to 0.02); P = .22; I2 = 24%]. Maximal change in creatinine levels after surgery was also comparable [standardized mean difference 0.07 (-0.23, 0.09); P = .39]. Early mortality was 2.9% and 3.7% in the N-acetyl cysteine and control cohorts respectively; [RD 0 (-0.03 to 0.02); P = .63; I2 = 20%]. Hospital stay (mean length of stay 10.4 and 10.1 days in the N-acetyl cysteine and control cohorts, respectively) was also similar in both cohorts [WMD 0.17 (-0.02 to 0.37) days; P = .81]. CONCLUSION: Prophylactic N-acetyl cysteine therapy does not reduce the incidence of renal dysfunction in high-risk patients undergoing cardiac surgery.

Levosimendan Reduces Mortality in Adults with Left Ventricular Dysfunction Undergoing Cardiac Surgery: A Systematic Review and Meta-analysis.

INTRODUCTION: Levosimendan is implemented in patients with low cardiac output after cardiac surgery. However, the strength of evidence is limited by randomized controlled trials enrolling a small number of patients. Hence we have conducted a systematic review to determine the role of levosimendan in adult cardiac surgery. METHODS: PUBMED, WoS, Cochrane database, and SCOPUS were systematically queried to identify original English language peer-reviewed literature (inception-October 2014) comparing clinical results of adult cardiac surgery between levosimendan and control. Pooled odds ratio (OR) was calculated using the Peto method; p < 0.05 is significant; results are presented within 95% confidence intervals. Continuous data was compared using standardized mean difference/mean difference. RESULTS: Fourteen studies were included in the analysis. Levosimendan reduced early mortality in patients with reduced ejection fraction (5.5% vs. 9.1%) (OR 0.48 [0.23-0.76]; p = 0.004). This result was confirmed using sensitivity analysis. Postoperative acute renal failure was lower with levosimendan therapy (7.4% vs. 11.5%). Intensive care unit stay was shorter in the levosimendan cohort comparable in both groups (standardized mean difference -0.31 [-0.53, -0.09]; p = 0.006; I(2) = 33.6%). Levosimendan-treated patients stayed 1.01 (1.61-0.42) days shorter when compared to control (p = 0.001). CONCLUSION: Our meta-analysis demonstrates that Levosimendan improves clinical outcomes in patients with left ventricular dysfunction undergoing cardiac surgery. Results of the ongoing multicenter randomized controlled trial are awaited to provide more conclusive evidence regarding the benefit of this drug.