Transcatheter aortic valve implantation against conventional aortic valve replacement surgery in high-risk patients with aortic stenosis; a cost-effectiveness analysis.

BACKGROUND: Aortic stenosis is a prevalent heart valvular disorder in Iran. Transcatheter Aortic Valve Implantation (TAVI) and Surgical Aortic Valve Replacement (SAVR) are two common procedures for treating the disease in the current clinical pathway. However, TAVI is an expensive procedure, and for Iran with severe limitations in financial resources, it is crucial to investigate the cost-effectiveness of the technology against other competing alternatives with the same purpose. This study aims to analyse the cost-effectiveness of TAVI vs SAVR in elderly patients who are at a higher risk of surgery. METHODS: This study is a decision economic evaluation modeling, with a lifetime horizon and a healthcare payer (health insurer) perspective. The utility values are from a previous study, transitional probabilities come from an established clinical trial called PARTNER-1, and the unit costs are from Iran's national fee schedule for medical services. The probabilistic and one-way sensitivity analyses have been performed to mitigate the uncertainty. RESULTS: The incremental cost, effectiveness, and cost-effectiveness ratio for the base case were: 368,180,101 Iranian Rial, (US$ 1,473), 0.37 QALY-per-patient, and, 995,081,354 Iranian Rial (US$ 3,980), respectively. The probabilistic sensitivity analysis yielded 981,765,302 I.R.I Rials (US$ 3,927) per patient for the ICER. The probability of being cost-effective at one and three times the country's Gross Domestic Production (GDP) is 0.31 and 0.83, respectively. CONCLUSIONS: TAVI does not seem a cost-effective procedure in comparison with SAVR at the current willingness to pay thresholds of the country. However, by increasing the WTP threshold to 3 times the GDP per capita the probability of being cost-effective will raise to 83%.

Pulsatile versus non-pulsatile perfusion in coronary artery bypass operation: The comparison of laboratory and clinical outcomes.

INTRODUCTION: The superiority of pulsatile or non-pulsatile perfusion in cardiopulmonary bypass (CPB) regarding morbidity and mortality is still debated. Therefore, we aimed to investigate the effect of different pulse rates in pulsatile perfusion in patients undergoing coronary artery bypass graft (CABG) and compared it with non-pulsatile perfusion. MATERIALS AND METHODS: In this randomized clinical trial, 90 patients who were all candidates for CABG under CPB were enrolled. Patients in groups A and B received pulsatile perfusion with 30 and 70 pulses per minute, and group C received non-pulsatile perfusion. The biochemical and clinical parameters in the ICU were evaluated in the study groups. RESULTS: There was no statistically significant difference between patients' clinical outcomes and kidney and liver function markers (all Ps> 0.05). Mean serum lactate level increased but did not show a statistically significant difference between the study groups (p = 0.8). The mean urine volume at 12 and 24 h after surgery was higher in group A, but there was no statistically significant difference between the three groups during the study period (p = 0.3). No significant difference was found in the length of the ICU stay between the study groups (p = 0.2). CONCLUSION: Our studied parameters demonstrated no significant difference between pulsatile and non-pulsatile and between 30 and 70 pulse rate pulsatile perfusion methods. Our findings support that pulsatile perfusion with different pulse rates has no advantages over non-pulsatile perfusion in selected CABG cases.

The effect of Del Nido versus custodiol cardioplegia on clinical outcomes and troponin-I changes among pediatrics with tetralogy of fallot undergoing cardiopulmonary bypass.

BACKGROUND: Myocardial protection during operations with cardiopulmonary bypass (CPB) and aortic cross clamping is vital. For this purpose, Del Nido (DN) and Custodiol cardioplegia (CC) solutions are used for single-dose cardioplegia in cardiac surgical procedures with CPB. Present study aimed to compare the effects of DN and CC on peri-operative clinical outcomes in pediatrics with Tetralogy of Fallot (TF) undergoing cardiopulmonary bypass. METHODS: Present randomized clinical trial was performed in two trial groups with parallel design. One group received DN and another group received CC. We assessed circulatory Troponin-I (cTnI) and coronary sinus lactate level as primary outcomes. Secondary outcomes were ventilation time, electrolytes levels, pump time, cross-clamp time and other clinical parameters. RESULTS: Duration of CPB and cross-clamp were the same in both groups. There were no significant differences in hemodynamic parameters, left ventricular ejection fraction after the surgery and discharge time between the two trial groups. Ventilation time (8.5 vs. 18; p = 0.001), ICU stay, Troponin-I in ICU admission and Coronary sinus lactate level (p = 0.001) were significantly higher among patients of Custodiol group compared to other trial group. Electrolytes Na, Cl and K levels, during CPB, were significantly less in Custodiol group. CONCLUSION: When used for inducing cardiac arrest during CPB, DN solution offers better maintenance of the electrolyte balance during CPB, and is associated with less circulatory cTnI and coronary sinus lactate level compared with the CC.

The Correlation of Lipid Peroxidation and Antioxidant Capacity on Perioperative Outcomes in On-Pump CABG in Adults.

Background: Cardiac surgeries in adults usually use cardiopulmonary bypass (CPB) for cardiac protection and provide a blood-free field for operation. However, due to changes in tissue perfusion and ischemia-reperfusion injury (IRI), there are some side effects for CPB operations. Lipid peroxidation and compromised antioxidant defense are consequences of IRI. This can, in turn, cause organ dysfunction and lead to unwanted biochemical and clinical changes. Methods: In a cross-sectional study 107 patients with the ages of 35 to 79 years old matching the inclusion criteria with indication for elective on-pump CABG were studied. Renal function, serum malondialdehyde (MDA) and total antioxidant capacity (TAC), and clinical outcomes were studied until 24 hours after intensive care unit (ICU) admission. Correlations between MDA and TAC and other outcomes were tested. Between-group comparisons was one-way ANOVA with repeated measures was used for inferring changes in the plasma TAC and MDA levels, creatinine, and BUN over time. Correlations were investigated using regression models. Results: Preoperative EF was inversely correlated with TAC at post- CPB time (r= -0.262, p= 0.031). Hyperlipidemia (HLP) was directly associated with higher MDA at post- CPB time (r= 0.267, p= 0.017. Cross-clamp and CPB duration were inversely correlated with the systemic MDA concentration at 24 hours post-ICU admission (r= -0.314, p= 0.005 and r= -0.312, p= 0.005, respectively). Preoperative TAC was inversely correlated with lactate at ICU admission (r= -0.294, p= 0.011). Creatine phosphokinase (CPK) and TAC were directly correlated with post-CPB time (r= -0.327, p= 0.006). Conclusion: According to the findings, a direct correlation between TAC and myocardial protection during CPB exists. Reduced TAC during CPB is associated with elevation of muscle damage marker CPK. Preoperative HLP is associated with higher circulatory MDA content at the post-CPB time.

Remote ischemic preconditioning effects on inflammatory markers and myocardial protection in coronary artery bypass graft surgery.

BACKGROUND: Induction of short episodes of ischemia to remote organs, namely upper or lower limbs, literally known as remote ischemic preconditioning (RIPC) has been suggested as a preconditioning approach to ameliorate ischemia/reperfusion injury (IRI). RIPC has been demonstrated to effectively protect various vital organs, including heart, against the next ischemic events in preclinical studies. However, human studies are required to approve its clinical applicability. Present study was performed to evaluate the effect of RIPC on the myocardial protection and inflammatory response markers in patients undergoing coronary artery bypass graft surgery. METHODS: In this randomized clinical trial, 43 coronary artery bypass graft (CABG) patients from Imam Hossein educational hospital were allocated in two groups, RIPC (21 patients) and control (22 patients). Serum level of interleukin (IL)-4, IL-8, and IL-10, interferon (IFN)-γ and Cardiac Troponin-I (cTnI) were measured in (1) after induction of anesthesia (before incision of skin), (2) after separation from CPB and (3) 24 hours after ICU arrival.Results:increase pack cell transfusions were observed in control group in ICU. Serum level of IL-10 at 24 hours after ICU admission was significantly higher in the RIPC group. Significantly lower amounts of IL-8 at post-CPB time were observed in the RIPC group in comparison with control.Conclusion:RIPC regulates the circulatory inflammatory cytokines, IL-8 decrement and IL-10 elevation, which could be translated into protection against IRI. However, further studies with larger sample sizes with careful consideration of parameters such as use of propofol as an anesthetic in the patients should be conducted to consolidate the findings from the current study.

Effect of Opium Addiction on Postoperative Arrhythmia Among Patients Undergoing CABG operation on Cardiopulmonary Bypass.

OBJECTIVES: Postoperative arrhythmia is an important complication of coronary artery bypass grafting (CABG) surgeries among patients. It seems that opioid usage is implicated in the pathogenesis of this condition due to its impacts on different organ systems, such as the autonomic nervous system. The present study was performed to investigate the effect of opium use on postoperative arrhythmia in patients undergoing CABG surgery. METHODS: Study participants were selected via convenience sampling from patients undergoing CABG surgery in a referral hospital. Study variables, including use of inotropic drugs, vital signs monitoring parameters and postoperative arrhythmia were observed and recorded at baseline and at follow-up time after surgery. RESULTS: Sixty-five (14.8%) patients had postoperative arrhythmia, and 104 participants were addicted. Prevalence of postoperative arrhythmia was the same among addict and non-addict patients. According to the regression analysis model, only serum level of epinephrine in operating room, heart rate and central venous pressure at baseline and 48 hours after operation are known as independent predictors of postoperative arrhythmia among study population. CONCLUSION: This study showed that although opium addiction increased postoperative arrhythmia among patients undergoing CABG surgery, this difference was not significant, and this association is probably mediated by other study variables.

Effect of opium addiction on postoperative arrhythmia among patients undergoing cabg operation on cardiopulmonary bypass

Abstract Objectives: Postoperative arrhythmia is an important complication of coronary artery bypass grafting (CABG) surgeries among patients. It seems that opioid usage is implicated in the pathogenesis of this condition due to its impacts on different organ systems, such as the autonomic nervous system. The present study was performed to investigate the effect of opium use on postoperative arrhythmia in patients undergoing CABG surgery. Methods: Study participants were selected via convenience sampling from patients undergoing CABG surgery in a referral hospital. Study variables, including use of inotropic drugs, vital signs monitoring parameters and postoperative arrhythmia were observed and recorded at baseline and at follow-up time after surgery. Results: Sixty-five (14.8%) patients had postoperative arrhythmia, and 104 participants were addicted. Prevalence of postoperative arrhythmia was the same among addict and non-addict patients. According to the regression analysis model, only serum level of epinephrine in operating room, heart rate and central venous pressure at baseline and 48 hours after operation are known as independent predictors of postoperative arrhythmia among study population. Conclusion: This study showed that although opium addiction increased postoperative arrhythmia among patients undergoing CABG surgery, this difference was not significant, and this association is probably mediated by other study variables.

Serum levels of interleukin-6, interleukin-8, interleukin-10, and tumor necrosis factor-α, renal function biochemical parameters and clinical outcomes in pediatric cardiopulmonary bypass surgery.

BACKGROUND: Cardiopulmonary bypass causes detrimental effects on remote organs due to inflammatory response. One of these organs is kidney that is frequently affected by cardiac surgery. Acute kidney injury is a post-cardiopulmonary bypass complication, which may result in increased post-operative morbidity and mortality. Post-cardiopulmonary bypass inflammatory response may contribute to remote organ dysfunction. In the present study, we investigated the relation between cytokines including interleukin-6, interleukin-8, interleukin-10, and tumor necrosis factor-α, and renal function tests such as creatinine and blood urea nitrogen (BUN). METHODS: In total, 91 patients between the ages of 4 and 60 months were enrolled for elective cardiac surgery with cardiopulmonary bypass after informed consent. Data regarding renal function tests and clinical outcomes were carefully recorded until 24 hours after admission to intensive care unit and analyzed. RESULTS: Our findings support that there is a direct correlation between cytokines including interleukin-6, interleukin-8, interleukin-10, and tumor necrosis factor-α and cardiopulmonary bypass time, duration of operation, and intensive care unit stay. Longer cardiopulmonary bypass time was associated with higher interleukin-8 at cross-clamp removal and 24 hours post- intensive care unit as well as higher interleukin-10 at declamp time. Higher interleukin-6 at declamp time was directly correlated with higher post-operative BUN. Interleukin-8 level after anesthesia induction was directly correlated with intensive care unit stay duration. Higher blood interleukin-6 and tumor necrosis factor-α levels following 24 hours of admission to intensive care unit were associated with longer mechanical ventilation time. CONCLUSION: Higher circulatory pro-inflammatory cytokine level is associated with adverse outcomes such as increased intensive care unit stay and longer mechanical ventilation time in pediatric patients. It is also correlated with unfavorable biochemical parameter of renal function, BUN. Findings hint that proper control of the inflammatory response is vital for the control of unfavorable clinical and pathological outcomes.

Inflammatory cytokine response and cardiac troponin I changes in cardiopulmonary bypass using two cardioplegia solutions; del Nido and modified St. Thomas': a randomized controlled trial.

BACKGROUND: Long intervals of del Nido (DN) solution administration, 90 minutes, may result in rewarming of the myocardial tissue and elevate metabolic demand and hypoxia. This will potentially increase inflammatory response due to ischemia-reperfusion injury. We conducted this study to compare the inflammatory response between patients receiving DN and multi-dose St Thomas' cardioplegia solution (MST) in cardiopulmonary bypass (CPB) surgery for the correction of tetralogy of Fallot (TF). METHODS: Fifty-nine pediatric patients undergoing TF total correction surgery were randomly assigned into two groups: DN and MST. The patients' demographic data, blood chemistry parameters, hemodynamics and other clinical variables were recorded. TNF-a, IL-6, IL-8, IL-10 and cTnI were measured after anesthesia induction (before skin incision), immediately after cross-clamp removal and 24 hours after admission to the intensive care unit (ICU). RESULTS: Thirty-two patients of a mean age of 28.0±16.4 months received DN and 27 patients of a mean age of 24.2±15.9 months received MST. Perioperative clinical parameters were not significantly different between the two groups. Cytokine levels for all patients were significantly increased after surgery. Inter-group comparisons of cytokine levels demonstrated no significant differences in TNF-α, IL-6 and IL-8 cytokines levels. IL-10 level showed a moderately significant increase in the MST group compared to the DN group after surgery (2.94±0.9 vs. 2.46±0.61 log10 pg/mL, respectively; p=0.039). Postoperative lactate level was significantly different between two groups (2.475±1.29 vs 1.63±0.82 mg/dL in DN and MST groups, respectively; p=0.007). CTnI levels increased after surgery and remained constant until 24 hours after surgery. Significant differences between the MST and DN groups, at all times, were not detected. CONCLUSIONS: The anti-inflammatory cytokine response in the MST group is significantly better than in the DN group. This may be due to shorter intervals of the MST cardioplegia solution administration, which prevents rewarming of the myocardium, increased metabolic demand and hypoxia. Decreasing the intervals of DN administration may improve its cardioprotective properties.