430 research outputs found
How should I treat a patient with significant angina and a severe left anterior descending artery stenosis beyond the insertion of a left internal mammary artery jump graft (diagonal to LAD)?
BACKGROUND: A 60-year-old man with a history of previous coronary artery bypass grafting (saphenous vein grafting [SVG] to native right coronary artery [RCA] and sequential left internal mammary artery [LIMA] jump grafting to his native first diagonal [D1] and left anterior descending [LAD] arteries), who had developed a previous ischaemic cerebrovascular accident following femoral angiography, re-presented with further ischaemic cardiac symptoms.\ud
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INVESTIGATIONS: Physical examination, electrocardiography, biochemistry including high-sensitive troponin, echocardiography, and trans-radial angiography.\ud
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DIAGNOSIS: Severe native 3 vessel disease including ostial occlusion of the LAD, distal left circumflex and obtuse marginal (LCX/OM) disease and proximal RCA occlusion; occluded SVG to RCA, and evidence of a critical stenosis in the mid LAD distal to the insertion of the tortuous LIMA jump graft (diagonal to LAD).\ud
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TREATMENT: PCI to mid LAD lesion via LIMA jump graft from left trans-radial approach
Intravenous sodium nitrite in acute ST-elevation myocardial infarction: a randomized controlled trial (NIAMI).
AIM: Despite prompt revascularization of acute myocardial infarction (AMI), substantial myocardial injury may occur, in part a consequence of ischaemia reperfusion injury (IRI). There has been considerable interest in therapies that may reduce IRI. In experimental models of AMI, sodium nitrite substantially reduces IRI. In this double-blind randomized placebo controlled parallel-group trial, we investigated the effects of sodium nitrite administered immediately prior to reperfusion in patients with acute ST-elevation myocardial infarction (STEMI).
METHODS AND RESULTS: A total of 229 patients presenting with acute STEMI were randomized to receive either an i.v. infusion of 70 μmol sodium nitrite (n = 118) or matching placebo (n = 111) over 5 min immediately before primary percutaneous intervention (PPCI). Patients underwent cardiac magnetic resonance imaging (CMR) at 6-8 days and at 6 months and serial blood sampling was performed over 72 h for the measurement of plasma creatine kinase (CK) and Troponin I. Myocardial infarct size (extent of late gadolinium enhancement at 6-8 days by CMR-the primary endpoint) did not differ between nitrite and placebo groups after adjustment for area at risk, diabetes status, and centre (effect size -0.7% 95% CI: -2.2%, +0.7%; P = 0.34). There were no significant differences in any of the secondary endpoints, including plasma troponin I and CK area under the curve, left ventricular volumes (LV), and ejection fraction (EF) measured at 6-8 days and at 6 months and final infarct size (FIS) measured at 6 months.
CONCLUSIONS: Sodium nitrite administered intravenously immediately prior to reperfusion in patients with acute STEMI does not reduce infarct size
Transcatheter aortic valve implantation in failed bioprosthetic surgical valves.
IMPORTANCE: Owing to a considerable shift toward bioprosthesis implantation rather than mechanical valves, it is expected that patients will increasingly present with degenerated bioprostheses in the next few years. Transcatheter aortic valve-in-valve implantation is a less invasive approach for patients with structural valve deterioration; however, a comprehensive evaluation of survival after the procedure has not yet been performed.
OBJECTIVE: To determine the survival of patients after transcatheter valve-in-valve implantation inside failed surgical bioprosthetic valves.
DESIGN, SETTING, AND PARTICIPANTS: Correlates for survival were evaluated using a multinational valve-in-valve registry that included 459 patients with degenerated bioprosthetic valves undergoing valve-in-valve implantation between 2007 and May 2013 in 55 centers (mean age, 77.6 [SD, 9.8] years; 56% men; median Society of Thoracic Surgeons mortality prediction score, 9.8% [interquartile range, 7.7%-16%]). Surgical valves were classified as small (≤21 mm; 29.7%), intermediate (>21 and <25 mm; 39.3%), and large (≥25 mm; 31%). Implanted devices included both balloon- and self-expandable valves.
MAIN OUTCOMES AND MEASURES: Survival, stroke, and New York Heart Association functional class.
RESULTS: Modes of bioprosthesis failure were stenosis (n = 181 [39.4%]), regurgitation (n = 139 [30.3%]), and combined (n = 139 [30.3%]). The stenosis group had a higher percentage of small valves (37% vs 20.9% and 26.6% in the regurgitation and combined groups, respectively; P = .005). Within 1 month following valve-in-valve implantation, 35 (7.6%) patients died, 8 (1.7%) had major stroke, and 313 (92.6%) of surviving patients had good functional status (New York Heart Association class I/II). The overall 1-year Kaplan-Meier survival rate was 83.2% (95% CI, 80.8%-84.7%; 62 death events; 228 survivors). Patients in the stenosis group had worse 1-year survival (76.6%; 95% CI, 68.9%-83.1%; 34 deaths; 86 survivors) in comparison with the regurgitation group (91.2%; 95% CI, 85.7%-96.7%; 10 deaths; 76 survivors) and the combined group (83.9%; 95% CI, 76.8%-91%; 18 deaths; 66 survivors) (P = .01). Similarly, patients with small valves had worse 1-year survival (74.8% [95% CI, 66.2%-83.4%]; 27 deaths; 57 survivors) vs with intermediate-sized valves (81.8%; 95% CI, 75.3%-88.3%; 26 deaths; 92 survivors) and with large valves (93.3%; 95% CI, 85.7%-96.7%; 7 deaths; 73 survivors) (P = .001). Factors associated with mortality within 1 year included having small surgical bioprosthesis (≤21 mm; hazard ratio, 2.04; 95% CI, 1.14-3.67; P = .02) and baseline stenosis (vs regurgitation; hazard ratio, 3.07; 95% CI, 1.33-7.08; P = .008).
CONCLUSIONS AND RELEVANCE: In this registry of patients who underwent transcatheter valve-in-valve implantation for degenerated bioprosthetic aortic valves, overall 1-year survival was 83.2%. Survival was lower among patients with small bioprostheses and those with predominant surgical valve stenosis
Initial experience of a large, self-expanding, and fully recapturable transcatheter aortic valve: The UK & Ireland Implanters' registry.
OBJECTIVES: The UK & Ireland Implanters' registry is a multicenter registry which reports on real-world experience with novel transcatheter heart valves. BACKGROUND: The 34 mm Evolut R transcatheter aortic valve is a self-expanding and fully recapturable transcatheter aortic valve, designed to treat patients with a large aortic annulus. METHODS: Between January 2017 and April 2018, clinical, procedural and 30-day outcome data were prospectively collected from all patients receiving the 34 mm Evolut R valve across 17 participating centers in the United Kingdom and Ireland. The primary efficacy outcome was the Valve Academic Research Consortium-2(VARC-2)-defined endpoint of device success. The primary safety outcome was the VARC-2-defined composite endpoint of early safety at 30 days. RESULTS: A total of 217 patients underwent attempted implant. Mean age was 79.5 ± 8.8 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.2% ± 3.4%. Iliofemoral access was used in 91.2% of patients. Device success was 79.7%. Mean gradient was 7.0 ± 4.6 mmHg and effective orifice area 2.0 ± 0.6 cm2 . Paravalvular regurgitation was more than mild in 7.2%. A new permanent pacemaker was implanted in 15.7%. Early safety was demonstrated in 91.2%. At 30 days, all-cause mortality was 3.2%, stroke 3.7%, and major vascular complication 2.3%. CONCLUSIONS: Real-world experience of the 34 mm Evolut R transcatheter aortic valve demonstrated acceptable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation
First clinical evidence characterizing safety and efficacy of the new CoCr Biolimus-A9 eluting stent: The Biomatrix Alpha™ registry
Background The biolimus-eluting stent (BES) was the first to elute anti-proliferative drug from a biodegradable polymer. In the randomized LEADERS trial, a stainless steel BES showed non-inferior efficacy compared to a sirolimus-eluting stent and a long-term safety advantage. We report the first clinical efficacy and safety outcomes of a new thin-strut cobalt chromium biolimus-eluting stent (CoCr-BES) from an international multi-centre registry. Methods We studied 400 all-comer patients with coronary disease receiving CoCr-BES at 12 centres, with follow-up at 9 months and 2 years. The primary endpoint was incidence of major adverse cardiac events (MACE) at 9 months comprising cardiac death, myocardial infarction (MI), and clinically indicated target vessel revascularization (ci-TVR). Key protocol elements were the same as the randomized LEADERS trial to enable a historical control for propensity-matched comparison. Results Mean patient age was 65 ± 11 years, 19% had diabetes, and 55% presented with unstable angina or MI. On discharge, 96% of patients were on dual antiplatelet therapy (DAPT) and 69% were on DAPT at 9 months. MACE at 9 months occurred in 3.9% of patients, cardiac death in 0.8%, MI in 1.1% and ci-TVR in 2.7%. One patient (0.25%) experienced definite or probable stent thrombosis (ST). A propensity-adjusted comparison showed similar clinical outcomes to the BES arm in the LEADERS trial for the primary endpoint MACE. Conclusions The new CoCr-BES showed low rates of MACE, MI, ci-TVR and ST at 9 months, similar to the BES arm in LEADERS
2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC).
peer reviewe
Insights on Embolic Protection, Repositioning, and Stroke: A Subanalysis of the RESPOND Study
Cost-effectiveness of stepwise provisional versus systematic dual stenting strategies in patients with distal bifurcation left main stem lesions: Economic analysis of the EBC MAIN trial
\ua9 2024 BMJ Publishing Group. All rights reserved.Background In patients with distal bifurcation left main stem lesions requiring intervention, the European Bifurcation Club Left Main Coronary Stent Study trial found a non-significant difference in major adverse cardiac events (MACEs, composite of all-cause death, non-fatal myocardial infarction and target lesion revascularisation) favouring the stepwise provisional strategy, compared with the systematic dual stenting. Aims To estimate the 1-year cost-effectiveness of stepwise provisional versus systematic dual stenting strategies. Methods Costs in France and the UK, and MACE were calculated in both groups to estimate the incremental cost-effectiveness ratio (ICER). Uncertainty was explored by probabilistic bootstrapping. The analysis was conducted from the perspective of the healthcare provider with a time horizon of 1 year. Results The cost difference between the two groups was €-755 (€5700 in the stepwise provisional group and €6455 in the systematic dual stenting group, p value<0.01) in France and €-647 (€6728 and €7375, respectively, p value=0.08) in the UK. The point estimates for the ICERs found that stepwise provisional strategy was cost saving and improved outcomes with a probabilistic sensitivity analysis confirming dominance with an 80% probability. Conclusion The stepwise provisional strategy at 1 year is dominant compared with the systematic dual stenting strategy on both economic and clinical outcomes
Safety and performance of the ultrathin sirolimus-eluting coronary stent in an all-comer patient population: the S-FLEX UK-II registry
\ua9 Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. OBJECTIVE: We evaluated the clinical safety and performance of the ultrathin strut biodegradable polymer-coated Supraflex Cruz (Sahajanand Medical TechnologiesLtd., Surat, India) sirolimus-eluting stent (SES) in an all-comer patient population requiring coronary stent implantation. STUDY DESIGN: The study was a prospective, observational, multicentre, single-arm registry. STUDY SETTINGS: The study was conducted at 19 NHS Hospitals across the UK, from March 2020 to September 2021. STUDY PARTICIPANTS: A total of 1904 patients with symptomatic coronary artery disease (age ≥18 years) who underwent percutaneous coronary intervention with at least one Supraflex Cruz SES were enrolled. PRIMARY AND SECONDARY OUTCOMES MEASURE: The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI) and clinically indicated target lesion revascularisation (CI-TLR), at 12 months. Safety endpoints were stent thrombosis, all-cause death and any MI. Prespecified subgroups analysis included patients with diabetes mellitus, bifurcation lesion, type B2/C lesion defined as per ACC/AHA (American College of Cardiology/American Heart Association) lesion classification and long coronary lesions (>20 mm). RESULTS: A total of 2973 Supraflex Cruz SES were implanted in 1835 patients (mean age: 65.20\ub111.03 years). Of these, 404 patients had diabetes mellitus (491 lesions), 271 had bifurcation lesions (293 lesions), 1541 had type B2/C lesions (1832 lesions) and 985 had long coronary lesions (>20 mm, 1139 lesions). Among the overall population, device success was achieved in 98.2% of lesions. TLF occurred in 12 (0.7%) patients (0.3% cardiac death, 0.2% TV-MI, 0.2% CI-TLR) at 30 days and in 43 (2.3%) patients (0.8% cardiac death, 0.8% TV-MI, 0.8% CI-TLR) at 12 months follow-up. The rate of definite stent thrombosis was 0.3% in the overall population at 12 months. The incidence of TLF and stent thrombosis was 6.2% and 1% in the diabetic, 1.8% and none in bifurcation lesion, 2.5% and 0.3% in type B2/C lesion, and 2.7% and 0.3% in long coronary lesions (>20 mm) subgroups, respectively. at 12 months follow-up. CONCLUSION: The S-FLEX UK-II registry confirms the clinical safety and performance of the ultrathin Supraflex Cruz SES in an all-comer population with complex coronary artery disease, demonstrating low rates of TLF and stent thrombosis. TRIAL REGISTRATION NUMBER: ISRCTN39751665 (https://doi.org/10.1186/ISRCTN39751665)
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