Stentless aortic bioprostheses have been advocated as being superior to conventional bioprosthetic valves, with benefits including superior left ventricular mass regression and larger effective ...orifice area. Several high-quality randomized studies now exist on this topic, and we sought to summarize them by meta-analysis.
The literature was searched from 1995 to 2006, in MEDLINE, EMBASE, CRISP, metaRegister of Controlled Trials, and the Cochrane database. Experts were also contacted and reference lists searched. Studies were combined using the inverse variance fixed-effects model. Heterogeneity was assessed and a sensitivity analysis performed. Publication bias was also investigated.
Ten studies were identified that included 919 patients in which the Freedom (Sorin Biomedica Cardio, Via Crescentino, Italy), Freestyle (Medtronic, Minneapolis, MN), Prima Plus (Edwards Life Sciences, Irvine, CA) and the Toronto and Biocor (St Jude Medical, St. Paul, MN) valves were used. The mean aortic valve gradient was lower in the stentless groups, with a weighted mean difference (WMD) of -3.57 mm Hg (95% confidence interval CI, -4.36 to -2.78; p < 0.01). The left ventricular mass index was significantly lower in the stentless groups at 6 months (WMD, -6.42; 95% CI, -11.63 to -1.21; p = 0.02), but this improvement disappeared after 12 months (WMD, 1.19; 95% CI, -4.15 to 6.53; p = 0.66). The weighted mean increase in cross-clamp time was 23 minutes, and the increase in bypass time was 29 minutes with a stentless valve.
This meta-analysis showed that stentless aortic valves provide an improved level of left ventricular mass regression at 6 months, reduced aortic gradients, and an improved effective orifice area index, at the expense of a 23-minute longer cross-clamp time and a 29-minute longer bypass time.
Aims
Coronary artery bypass graft (CABG) surgery is the standard of care for the management of patients with severe three-vessel and left main coronary artery disease (CAD). However, the optimal ...strategy for management of patients with CAD and severe left ventricular (LV) dysfunction ejection fraction (EF) ≤35% is not clear. A meta-analysis of observational studies was performed to determine the operative mortality and long-term (5-year actuarial survival) outcomes among patients with severe LV dysfunction undergoing CABG.
Methods and results
A systematic computerized literature search was performed and observational studies consisting of patients undergoing isolated CABG for CAD and severe LV dysfunction were included. Studies that did not report operative mortality, long-term (≥1 year) survival data, or pre-operative EF and multiple studies from the same group were excluded. In total, 4119 patients from 26 observational clinical studies were included. The estimated mean age was 63.9 years and 82.4% of patients were men. The mean (estimate) pre-operative EF was 24.7% (95% CI 22.5-27.0%). The operative mortality among patients (26 studies, n= 3621) who underwent on-pump CABG was 5.4%, n= 189 (95% CI 4.5-6.4%). The 5-year actuarial survival among patients (13 studies, n= 1980) who underwent on-pump CABG was 73.4%, n= 1483 (95% CI 68.7-77.7%). Patients who underwent off-pump CABG (7 studies, n= 498) tended to have reduced operative mortality of 4.4%, n= 20 (95% CI 2.8-6.4%). The mean (estimate) post-operative EF was 35.19% (95% CI 31.95-38.43%).
Conclusion
The present meta-analysis demonstrates that based on data from available observational clinical studies, CABG can be performed with acceptable operative mortality and 5-year actuarial survival in patients with severe LV dysfunction.
Objectives The goal of this analysis was to determine the association between intraprocedural complications and clinical outcomes among patients with high-risk non–ST-segment elevation acute coronary ...syndrome (NSTEACS) undergoing percutaneous coronary intervention (PCI). Background Among patients undergoing PCI for NSTEACS, the relationship between intraprocedural complications and clinical outcomes, independent of epicardial and myocardial perfusion, has not been well characterized. Methods The EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non–ST-Segment Elevation Acute Coronary Syndrome) trial enrolled 9,406 patients with high-risk NSTEACS undergoing an early invasive strategy. Of these, 1,452 underwent angiographic assessment in an independent core laboratory and did not have a myocardial infarction (MI) between enrollment and angiography. We assessed the relationship between abrupt closure, loss of side branch(es), distal embolization, and no-reflow phenomenon and 30-day clinical outcomes in these patients. Results Of the patients, 166 (11.4%) experienced an intraprocedural complication. Baseline clinical characteristics were similar between patients who did and did not have complications. The 30-day composite of death or MI was significantly higher among patients with an intraprocedural complication (28.3% vs. 7.8%, odds ratio OR: 4.68, 95% confidence interval CI: 3.2 to 7.0, p < 0.001). Individually, both mortality (3.0% vs. 0.9%, OR: 3.60, 95% CI: 1.2 to 10.5, p = 0.019) and MI (27.1% vs. 7.4%, OR: 4.66, 95% CI: 3.1 to 7.0, p < 0.001) were significantly increased. After adjusting for differences in post-PCI epicardial and myocardial perfusion, the association with 30-day death or MI remained significant. Conclusions Among high-risk NSTEACS patients undergoing an invasive strategy, the incidence of intraprocedural complications is high, and the occurrence of these complications is associated with worse clinical outcomes independent of epicardial and myocardial perfusion. (Early Glycoprotein IIb/IIIa Inhibition in Patients With Non–ST-segment Elevation Acute Coronary Syndrome EARLY ACS; NCT00089895 )
Background Early (30 days) and midterm (6 months) clinical outcomes in trials comparing rescue angioplasty (rescue percutaneous coronary intervention rPCI) with conservative treatment of failed ...fibrinolysis complicating ST-segment elevation myocardial infarction have shown variable results. Whether early rPCI confers late (up to 3 years) clinical benefits is not known. Methods The MERLIN trial compared rPCI and a conservative strategy in patients with failed fibrinolysis complicating ST-segment elevation myocardial infarction. Three hundred seven patients with electrocardiographic evidence of failure to reperfuse at 60 minutes were included. Patients in cardiogenic shock were excluded. Thirty-day and 1-year results have been reported. Results of 3 years of follow-up are presented. Results Three-year mortality in the conservative arm and rPCI, respectively, was 16.9% versus 17.6% ( P = .9, relative difference RD −0.8, 95% CI −9.3 to 7.8). Death rates were similar (3.9% vs 3.2%) between 1- and 3-year follow-up, respectively. The incidence of the composite secondary end point of death, reinfarction, stroke, unplanned revascularization, or heart failure was significantly higher in the conservative arm (64.3% vs 49%, P = .01, RD 15.3, 95% CI 4.2-26). There was no significant difference in the rate of reinfarction (0.7% vs 0.7%) or heart failure (1.3% vs 2.7%) between 1 and 3 years between the conservative and rPCI arms, respectively. The incidence of subsequent unplanned revascularization at 3 years was significantly higher in the conservative arm (33.8% vs 14.4%, P < .01, RD 19.4, 95% CI 10-28.7), most of which occurred within 1 year; the rates between 1 and 3 years were 3.9% in the conservative arm versus 2% in the rPCI arm. There was a trend toward fewer strokes in the conservative arm at 3 years (conservative arm 2.6% vs rPCI 6.5%, P = .1, RD −3.9%, 95% CI −9.4 to 0.8), with similar stroke rates (1.3% vs 1.3%) between 1- and 3-year follow-up. Conclusions Rescue angioplasty did not confer a late survival advantage at 3 years. The composite end point occurred less often in the rPCI arm mainly because of fewer unplanned revascularization procedures in the early phase of follow-up. The highest risk of clinical events in patients with failed reperfusion is in the first year, beyond which the rate of clinical events is low.
Abstract Background Contrast induced nephropathy (CIN) is a serious but rare complication following contrast based procedures. Sodium bicarbonate (NaHCO3 ) has been postulated to prevent CIN by ...various mechanisms. However, the outcomes following sodium bicarbonate administration to prevent CIN have been inconsistent. Methods A meta-analysis of published randomized clinical trials to determine if the administration of sodium bicarbonate is superior to sodium chloride among patients with chronic renal failure undergoing catheterization and interventional procedures in preventing CIN was performed. Results Data were combined across seven published clinical trials consisting of 1734 patients. There were no significant differences in the baseline characteristics between the NaHCO3 and NaCl groups except patients in the bicarbonate group were heavier ( P = 0.04). The odds ratio (OR) for the development of contrast nephropathy for NaHCO3 versus NaCl was 0.33 (95% confidence interval CI 0.16–0.69; P = 0.003). Heterogeneity and publication bias were detectable with P -values 0.01 and 0.0005 respectively. There was no difference between the NaHCO3 group and the NaCl group in the occurrence of death OR 0.6; 95% CI (0.26–1.41); P = 0.24, congestive heart failure OR 0.85; 95% CI (0.32–2.24); P = 0.74 and the requirement for renal replacement therapy OR 0.56; 95% CI (0.22–1.41); P = 0.22. Conclusion This meta-analysis demonstrates that based on currently available randomized trials, the administration of NaHCO3 is superior to the administration of NaCl alone in the prevention of CIN among patients with moderate to severe chronic kidney disease. However, further controlled clinical trials are needed due to significant study heterogeneity and publication bias.
In patients with ST-segment elevation myocardial infarction (STEMI), the restoration of normal epicardial flow following fibrinolytic administration is associated with improved clinical outcomes. The ...goal of this analysis was to examine the relation between hyperemic flow and outcomes following fibrinolytic administration for STEMI. In Clopidogrel as Adjunctive Reperfusion Therapy–Thrombolysis In Myocardial Infarction 28 (CLARITY-TIMI 28), patients with STEMI (n = 3,491) treated with fibrinolytic therapy were scheduled to undergo angiography 48 to 192 hours after randomization. Corrected TIMI frame count (CTFC) and TIMI myocardial perfusion grade (TMPG) were assessed, and their associations with outcomes at 30 days were evaluated. When evaluating initial angiography of the infarct-related artery, there was a nearly linear relation between CTFC and 30-day mortality, with faster flow (lower CTFC) associated with improved outcomes. Conversely, in patients who underwent percutaneous coronary intervention (PCI), very fast flow (CTFC <14) after intervention was associated with worse outcomes. Post-PCI hyperemic flow (CTFC <14) was associated with a higher incidence of mortality (p = 0.056), recurrent myocardial infarction (p = 0.011), and a composite of death or myocardial infarction (p <0.001) compared with normal flow (CTFC 14 to 28). When post-PCI CTFC was further stratified by TMPG, there was a U-shaped relation between mortality and CTFC in patients with poor myocardial perfusion (TMPG 0 or 1). This relation appeared to be linear in patients with TMPG 2 or 3. In conclusion, in patients who undergo PCI after fibrinolytic therapy for STEMI, hyperemic flow on coronary angiography is associated with an increased incidence of adverse outcomes. Hyperemic flow with associated impaired myocardial perfusion may be a marker of more extensive downstream microembolization.
Concerns regarding radiation exposure and its effects during pregnancy are often quoted as an important barrier preventing many women from pursuing a career in Interventional Cardiology. Finding the ...true risk of radiation exposure from performing cardiac catheterisation procedures can be challenging and guidelines for pregnancy exposure have been inadequate. The Women in Innovations group of Cardiologists with endorsement of the Society for Cardiovascular Angiography and Interventions aim to provide guidance in this publication by describing the risk of radiation exposure to pregnant physicians and cardiac catheterisation personnel, to educate on appropriate radiation monitoring and to encourage mechanisms to reduce radiation exposure. Current data do not suggest a significant increased risk to the foetus of pregnant women in the cardiac catheterisation laboratory and thus do not justify precluding pregnant physicians from performing procedures in the cardiac catheterisation laboratory. However, radiation exposure amongst pregnant physicians should be properly monitored and adequate radiation safety measures are still warranted.
Methods: 184 consecutive patients (>=75 years) with NSTEACS managed by coronary angiography and or percutaneous coronary intervention in a tertiary cardiac centre were recruited into an ongoing study ...(ICON1-A Study to Improve Cardiovascular Outcomes in High Risk PatieNts with Acute Coronary Syndrome).
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