The outcome of intra-aortic balloon pump support in acute myocardial infarction complicated by cardiogenic shock according to the type of revascularization: a comprehensive meta-analysis.

AIMS: Despite the recommendations of the current guidelines, scientific evidence continue to challenge the effectiveness of intra-aortic balloon pump (IABP) in acute myocardial infarction (AMI) complicated by cardiogenic shock. Moreover, 2 recent meta-analyses showed contrasting results. The aim of this study is to test the effect of IABP according to the type of therapeutic treatment of AMI: percutaneous coronary intervention (PCI), thrombolytic therapy (TT), or medical therapy without reperfusion. Articles published from January 1, 1986, to December 31, 2012, were collected and analyzed by meta-analysis. METHODS AND RESULTS: We evaluated the IABP impact on inhospital mortality, on safety end points (stroke, severe bleeding) and long-term survival, using risk ratio (RR) and risk difference (RD) estimates. We found that the risk of death was (i) not significantly different between the IABP and control groups (RR 0.95, P = .52; RD -0.04, P = .28), (ii) significantly reduced in the TT subgroup (RR 0.77, P < .0001; RD -0.16, P < .0001), and (iii) significantly increased in the PCI subgroup (RR 1.18, P = .01; RD 0.07, P = .01). There were no significant differences in secondary end points (P, not significant). In addition, we compared the meta-analyses collected over the same search period. CONCLUSION: The results show that IABP support is significantly effective in TT reperfusion but is associated with a significant increase of the inhospital mortality with primary PCI. The comparison of the meta-analyses demonstrates the key role of analysing primary clinical treatments to avoid systematic errors.

Transcatheter aortic valve implantation results are not superimposable to surgery in patients with aortic stenosis at low surgical risk.

BACKGROUND: The aim of this meta-analysis was to compare the impact of transcatheter aortic valve implantation (TAVI) vs. surgical aortic valve replacement (SAVR) in patients with severe aortic valve stenosis (AS) at low surgical risk. METHODS: All randomized controlled trials (RCTs) and observational studies (Obs) published from January 2014 until March 31st, 2020 were retrieved through the PubMed computerized database and at the site https://www. CLINICALTRIALS: com. The relative risk (RR) with the 95% confidence interval (CI) was used to evaluate the effect of the intervention under comparison. The primary endpoints were all-cause 30-day mortality and 1-year mortality. The 30-day safety endpoints were: stroke, acute kidney injury stage 2 or 3, major bleeding, moderate/severe paravalvular leak, need for new permanent pacemaker (PM) implantation. RESULTS: After detailed review 9 studies, related to 4 RCTs and 5 Obs, were selected. The overall analysis of RCTs plus Obs showed a significantly lower 30-day mortality for TAVI (RR = 0.55; 95% CI 0.45-0.68, p < 0.00001; I2 = 0%). However, an increased risk of new PM implantation (RR = 2.87; 95% CI 2.01-3.67, p < 0.00001, I2 = 0%) and of paravalvular leak (RR = 7.28; 95% CI 3.83-13.81, p < 0.00001, I2 = 0%) was observed in TAVI compared to SAVR. On the contrary, a lower incidence of major bleeding (RR = 0.38; 95% CI 0.27-0.54, p < 0.00001, I2 = 0%) and of acute kidney injury was observed (RR = 0.33; 95% CI 0.19-0.56, p < 0.0001, I2 = 0%) in TAVI. CONCLUSIONS: TAVI and SVAR in the treatment of AS in the patients at low surgical risk are not superimposable. In particular, if 30-day and 1-year mortality, major bleeding and acute kidney injury were significantly lower for TAVI, the need of new PM implantation and paravalvular leak were significantly lower in SAVR. Consequently, we suggest the need of more trials to evaluate the effectiveness of TAVI as routine therapeutic procedure in the treatment of patients with low surgical risk AS.

Percutaneous assist devices in acute myocardial infarction with cardiogenic shock: Review, meta-analysis.

AIM: To assess the impact of percutaneous cardiac support in cardiogenic shock (CS) complicating acute myocardial infarction (AMI), treated with percutaneous coronary intervention. METHODS: We selected all of the studies published from January 1(st), 1997 to May 15(st), 2015 that compared the following percutaneous mechanical support in patients with CS due to AMI undergoing myocardial revascularization: (1) intra-aortic balloon pump (IABP) vs Medical therapy; (2) percutaneous left ventricular assist devices (PLVADs) vs IABP; (3) complete extracorporeal life support with extracorporeal membrane oxygenation (ECMO) plus IABP vs IABP alone; and (4) ECMO plus IABP vs ECMO alone, in patients with AMI and CS undergoing myocardial revascularization. We evaluated the impact of the support devices on primary and secondary endpoints. Primary endpoint was the inhospital mortality due to any cause during the same hospital stay and secondary endpoint late mortality at 6-12 mo of follow-up. RESULTS: One thousand two hundred and seventy-two studies met the initial screening criteria. After detailed review, only 30 were selected. There were 6 eligible randomized controlled trials and 24 eligible observational studies totaling 15799 patients. We found that the inhospital mortality was: (1) significantly higher with IABP support vs medical therapy (RR = +15%, P = 0.0002); (2) was higher, although not significantly, with PLVADs compared to IABP (RR = +14%, P = 0.21); and (3) significantly lower in patients treated with ECMO plus IABP vs IABP (RR = -44%, P = 0.0008) or ECMO (RR = -20%, P = 0.006) alone. In addition, Trial Sequential Analysis showed that in the comparison of IABP vs medical therapy, the sample size was adequate to demonstrate a significant increase in risk due to IABP. CONCLUSION: Inhospital mortality was significantly higher with IABP vs medical therapy. PLVADs did not reduce early mortality. ECMO plus IABP significantly reduced inhospital mortality compared to IABP.

Lack of intra-aortic balloon pump effectiveness in high-risk percutaneous coronary interventions without cardiogenic shock: a comprehensive meta-analysis of randomised trials and observational studies.

BACKGROUND: Although controversial, using prophylactic intra-aortic balloon pump (IABP) in patients undergoing high-risk percutaneous coronary intervention (PCI) has been reported to be effective by numerous registry studies. However, conflicting findings were observed in observational studies (Obs.) and randomised controlled trials (RCTs). OBJECTIVE: The purpose of this meta-analysis was to assess the impact of IABP on in-hospital deaths, major adverse cardiovascular events (MACCE), access-site complications and stroke in high-risk PCI cases from Obs. and RCTs published from 1st January, 1990 to 31st March, 2012 and indexed in PubMed. METHODS AND RESULTS: We retrieved 1125 studies from the database; 11 studies compared the effects of IABP support, i.e., prophylactic administration (P-IABP) vs. no support (No-IABP), in high-risk patients undergoing PCI. These studies were included in the meta-analysis. We then calculated risk ratios (RRs) and risk differences (RDs) between the two groups of patients (P-IABP vs. No-IABP). We did not observe significant in-hospital mortality, MACCE, access-site complications or stroke differences in the RRs and RDs of the two groups. CONCLUSIONS: The results suggest that PCI plus P-IABP support does not result in reduced in-hospital mortality or MACCE nor in significant higher access-site complications or stroke incidence compared with PCI alone in patients at high risk for peri-procedural PCI complications.

Alfentanil and sufentanil in fast-track anesthesia for coronary artery bypass graft surgery.

OBJECTIVE: To evaluate alfentanil, sufentanil, and the combination of both opioids in patients undergoing cardiac surgery. DESIGN: Prospective, randomized study. SETTING: University hospital. PARTICIPANTS: Patients undergoing coronary artery bypass graft (CABG) surgery (n = 195), randomly assigned to 3 groups of 65 each. INTERVENTIONS: Patients in group A received alfentanil, induction (15 microg/kg) and maintenance (15 microg/kg/hr); patients in group S received sufentanil, induction (1 microg/kg) and maintenance (1 microg/kg/h); and patients in group AS received alfentanil and sufentanil, induction with alfentanil (15 microg/kg) and maintenance with sufentanil (1 microg/kg/hr). MEASUREMENTS AND MAIN RESULTS: Hemodynamic data showed a reduction of all parameters at induction in the 3 groups (p < 0.05). Cardiac index decreased at induction in all groups (p < 0.05) but increased in groups S and AS toward baseline values at the end of surgery. The intubation time and length of stay in the intensive care unit were less in group AS (2.3 +/- 1.2 hours; p < 0.001 and 20 +/- 8 hours; p < 0.05), than in groups A (4.2 +/- 1.7 hours and 28 +/- 13 hours) and S (3.1 +/- 1.1 hours; p < 0.05 and 26 +/- 12 hours). Length of hospital stay and patients' outcome were similar in the 3 groups. CONCLUSION: Although the differences among groups regarding extubation time, intensive care unit length of stay, and some hemodynamic data were statistically significant, the differences were clinically small. All 3 anesthetic protocols were shown to be safe and appropriate for patients undergoing elective coronary artery bypass graft surgery and early postoperative tracheal extubation.