Abstract Background Although the prognostic value of findings from cardiac magnetic resonance (CMR) imaging has been established in single-center center studies in patients with ST-segment elevation ...myocardial infarction (STEMI), a large multicenter investigation to evaluate the prognostic significance of myocardial damage and reperfusion injury is lacking. Objectives The aim of this study was to assess the prognostic impact of CMR in an adequately powered multicenter study and to evaluate the most potent CMR predictor of hard clinical events in a STEMI population treated by primary percutaneous coronary intervention (PCI). Methods We enrolled 738 STEMI patients in this CMR study at 8 centers. The patients were reperfused by primary PCI <12 h after symptom onset. Central core laboratory–masked analyses for quantified left ventricular (LV) function, infarct size (IS), microvascular obstruction (MO), and myocardial salvage were performed. The primary clinical endpoint of the study was the occurrence of major adverse cardiac events. Results Patients with cardiovascular events had significantly larger infarcts (p < 0.001), less myocardial salvage (p = 0.01), a larger extent of MO (p = 0.009), and more pronounced LV dysfunction (p < 0.001). In a multivariate model that included clinical and other established prognostic parameters, MO remained the only significant predictor in addition to the TIMI (Thrombolysis In Myocardial Infarction) risk score. IS and MO provided an incremental prognostic value above clinical risk assessment and LV ejection fraction (c-index increase from 0.761 to 0.801; p = 0.036). Conclusions In a large, multicenter STEMI population reperfused by primary PCI, CMR markers of myocardial damage (IS and especially MO) provide independent and incremental prognostic information in addition to clinical risk scores and LV ejection fraction. (Abciximab i.v. Versus i.c. in ST-elevation Myocardial Infarction AIDA STEMI; NCT00712101 ).
Abstract Objectives The aims of this study were to assess the impact of atrial fibrillation (AF) on outcome in transfemoral aortic valve replacement (TAVR) and to evaluate the safety and efficacy of ...apixaban compared with a vitamin K antagonist (VKA) in patients with AF after TAVR. Background Non-VKA oral anticoagulant agents have not been systematically used in patients with AF after TAVR. Methods Of the 617 patients enrolled, 55.9% (n = 345) were in sinus rhythm and 44.1% (n = 272) in AF. Clinical follow-up was performed after 30 days and 12 months. Results The early safety endpoint at 30 days was significantly more frequent in patients with AF compared with those in sinus rhythm (23.2% vs. 11.0%; p < 0.01). During 12-month follow-up, the secondary endpoint of all-cause mortality and stroke was significantly higher in patients with AF (20.6% vs. 9.7%; p = 0.02), driven by a significantly higher rate of all-cause mortality (19.1% vs. 7.8%; p = 0.01). Among patients with AF, 141 (51.8%) were treated with apixaban and 131 (48.2%) with a VKA. There was a significantly lower rate of the early safety endpoint in patients with AF treated with apixaban compared with patients treated with a VKA (13.5% vs. 30.5%; p < 0.01), with a numerically lower stroke rate (2.1% vs. 5.3%; p = 0.17) at 30 days and 12 months (1.2% vs. 2.0%; p = 0.73) of follow-up. Conclusions In patients undergoing TAVR, AF was associated with a significantly higher rate of all-cause mortality throughout 12 months follow-up. The early safety endpoint in patients with AF on apixaban was significantly less frequent compared with patients receiving a VKA.
Background
In patients at increased surgical risk, transcatheter edge‐to‐edge mitral valve repair by MitraClip implantation for severe mitral regurgitation (MR) has proven to relieve symptoms of MR, ...reduce New York Heart Association (NYHA) functional class and improve quality of life. Rehospitalization for decompensated heart failure occurs frequently after MitraClip implantation, negatively impacting quality of life. We aimed here to determine predictors of 1‐year rehospitalization for decompensated heart failure.
Methods and results
A total of 355 consecutive patients who underwent MitraClip implantation at our centre were evaluated for their baseline and procedural characteristics, peri‐procedural outcome and clinical endpoints. Rate of rehospitalization for decompensated heart failure was reduced from 52.7% (n = 187) in the year before MitraClip procedure to 18.0% (n = 64) (P < 0.0001) in the first year after MitraClip implantation. The mean duration until rehospitalization was 117 days after MitraClip implantation. Multivariate Cox proportional hazards regression analysis identified baseline left ventricular ejection fraction (P = 0.020), baseline troponin T (P = 0.003) and pre‐procedural NYHA class (P = 0.020) as independent predictors for 1‐year rehospitalization after MitraClip implantation. Rehospitalization correlated significantly with all‐cause mortality (odds ratio 2.3, 95% confidence interval 1.3–4.1; P = 0.004) and cardiovascular mortality (odds ratio 3.3, 95% confidence interval 1.7–6.1; P = 0.0003).
Conclusion
After MitraClip implantation, annual rate of rehospitalization for decompensated heart failure was reduced by 65.8%. Baseline left ventricular ejection fraction, baseline troponin T and pre‐procedural NYHA functional class are independent predictors for rehospitalization within the first year after MitraClip implantation. Patients readmitted for decompensated heart failure after MitraClip implantation had a 2.3‐fold increased risk of all‐cause mortality and a 3.3‐fold increased risk of cardiovascular mortality compared to patients not requiring rehospitalization.
The third generation Edwards Sapien 3 (Edwards Lifesciences Inc., Irvine, California) system was optimized to reduce residual aortic regurgitation and vascular complications.
235 patients with severe ...symptomatic aortic stenosis were prospectively enrolled. Transcatheter aortic valve implantations (TAVI) were performed without general anesthesia by transfemoral approach. Patients were followed for 30 days. Patients received 23mm (N = 77), 26mm (N = 91) or 29mm (N = 67) valve based on pre-procedural 256 multislice computer tomography. Mean oversizing did not differ between the 3 valves. There was no residual moderate or severe aortic regurgitation. Rate of mild aortic regurgitation and regurgitation index did not differ between groups. There was no switch to general anesthesia or conversion to surgery. Rate of major vascular complication was 3.0% with no difference between valve and delivery sheath sizes. Within 30 days rates of all cause mortality (2.6%) and stroke (2.1%) were low.
In patients with severe aortic stenosis transfemoral TAVI with the Edwards Sapien 3 valve without general anesthesia was associated with a high rate of device success, no moderate or severe residual aortic regurgitation, low rates of major vascular complication, mortality and stroke within 30 days with no difference between the 3 valve sizes.
ClinicalTrials.gov NCT02162069.
RESPOND is a prospective, open-label, single-arm study evaluating the outcomes following transcatheter aortic valve implantation (TAVI) with the repositionable and fully retrievable Lotus Valve used ...in routine clinical practice for the treatment of patients with aortic valve stenosis.
RESPOND enrolled 1014 patients at sites across Europe, New Zealand, and Latin America; 996 patients received a Lotus Valve (mean age: 80.8 years; 50.8% female; Society of Thoracic Surgeons score: 6.0 ± 6.9). Repositioning was attempted in 29.2% of patients, with 99% success. The rate of all-cause mortality in the intent-to-treat population at 30 days (primary endpoint) was 2.6% (P < 0.001 vs. pre-specified performance goal). Thirty-day clinical follow-up was completed for 97.3% of patients. Among patients who received a Lotus Valve, the 30-day overall and disabling stroke rates were 3.0% and 2.2%, respectively. The 30-day permanent pacemaker implantation rate was 30.0% in all patients, and 34.6% in pacemaker-naïve patients. Echocardiographic data at baseline and pre-discharge were assessed by an independent core laboratory. Mean aortic valve gradient declined from 37.7 ± 15.2 mmHg at baseline to 10.8 ± 4.6 mmHg at hospital discharge (P < 0.001). Aortic valve area increased from 0.7 ± 0.2 cm2 at baseline to 1.8 ± 0.4 cm2 at discharge (P < 0.001). At hospital discharge, paravalvular leak (PVL) was absent or trace in 92% of patients; no patients had severe PVL, 0.3% of patients exhibited moderate PVL, and 7.7% of patients had mild PVL. Clinical follow-up in RESPOND will extend to 5 years.
The results of RESPOND confirm the safety and efficacy of TAVI with the Lotus Valve in routine clinical practice.
ClinicalTrials.gov #NCT 02031302.
Summary Background Intracoronary administration of an abciximab bolus during a primary percutaneous coronary intervention results in a high local drug concentration, improved perfusion, and reduction ...of infarct size compared with intravenous bolus application. However, the safety and efficacy of intracoronary versus standard intravenous bolus application in patients with ST-elevation myocardial infarction (STEMI) undergoing this intervention has not been tested in a large-scale clinical trial. Methods The AIDA STEMI trial was a randomised, open-label, multicentre trial. Patients presenting with STEMI in the previous 12 h with no contraindications for abciximab were randomly assigned in a 1:1 ratio by a central web-based randomisation system to intracoronary versus intravenous abciximab bolus (0·25 mg/kg bodyweight) during percutaneous coronary intervention with a subsequent 12 h intravenous infusion 0·125 μg/kg per min (maximum 10 μg/min). The primary endpoint was a composite of all-cause mortality, recurrent infarction, or new congestive heart failure within 90 days of randomisation. Secondary endpoints were the time to occurrence of the primary endpoint, each individual component of that endpoint, early ST-segment resolution, thrombolysis in myocardial infarction (TIMI) flow grade, and enzymatic infarct size. A masked central committee adjudicated the primary outcome and its components. Treatment allocation was not concealed from patients and investigators. This trial is registered with ClinicalTrials.gov , NCT00712101. Findings Between July, 2008, and April, 2011, 2065 patients were randomly assigned intracoronary abciximab (n=1032) or intravenous abciximab (n=1033). Intracoronary, as compared with intravenous abciximab, resulted in a similar rate of the primary composite clinical endpoint at 90 days in 1876 analysable patients (7·0% vs 7·6%; odds ratio OR 0·91; 95% CI 0·64–1·28; p=0·58). The incidence of death (4·5% vs 3·6%; 1·24; 0·78–1·97; p=0·36) and reinfarction (1·8% vs 1·8%; 1·0; 0·51–1·96; p=0·99) did not differ between the treatment groups, whereas less patients in the intracoronary group had new congestive heart failure (2·4% vs 4·1%; 0·57; 0·33–0·97; p=0·04). None of the secondary endpoints or safety measures differed significantly between groups. Interpretation In patients with STEMI undergoing primary percutaneous coronary intervention, intracoronary as compared to intravenous abciximab did not result in a difference in the combined endpoint of death, reinfarction, or congestive heart failure. Since intracoronary abciximab bolus administration is safe and might be related to reduced rates of congestive heart failure the intracoronary route might be preferred if abciximab is indicated. Funding Lilly, Germany. University of Leipzig—Heart Centre. University of Leipzig, Clinical Trial Centre Leipzig, supported by the Federal Ministry of Education and Research (BMBF).
Objectives The aim of the AIDA STEMI (Abciximab i.v. Versus i.c. in ST-elevation Myocardial Infarction) cardiac magnetic resonance (CMR) substudy was to investigate potential benefits of ...intracoronary versus intravenous abciximab bolus administration on infarct size and reperfusion injury in ST-segment elevation myocardial infarction. Background The AIDA STEMI trial randomized 2,065 patients to intracoronary or intravenous abciximab and found similar rates of major adverse cardiac events at 90 days with significantly less congestive heart failure in the intracoronary abciximab group. CMR can directly visualize myocardial damage and reperfusion injury, thereby providing mechanistic and pathophysiological insights. Methods We enrolled 795 patients in the AIDA STEMI CMR substudy. CMR was completed within 1 week after ST-segment elevation myocardial infarction. Central core laboratory–masked analyses for quantified ventricular function, volumes, infarct size, microvascular obstruction, hemorrhage, and myocardial salvage were performed. Results The area at risk (p = 0.97) and final infarct size (16% interquartile range: 9% to 25% versus 17% interquartile range: 8% to 25%, p = 0.52) did not differ significantly between the intracoronary and the intravenous abciximab groups. Consequently, the myocardial salvage index was similar (52 interquartile range: 35 to 69 versus 50 interquartile range: 29 to 69, p = 0.25). There were also no differences in microvascular obstruction (p = 0.19), intramyocardial hemorrhage (p = 0.19), or ejection fraction (p = 0.95) between both treatment groups. Patients in whom major adverse cardiac events occurred had significantly larger infarcts, less myocardial salvage, and more pronounced ventricular dysfunction. Conclusions This largest multicenter CMR study in ST-segment elevation myocardial infarction patients to date demonstrates no benefit of intracoronary versus intravenous abciximab administration on myocardial damage and/or reperfusion injury. Infarct size determined by CMR was significantly associated with major adverse cardiac events. (Abciximab i.v. Versus i.c. in ST-elevation Myocardial Infarction AIDA STEMI; NCT00712101 )
Aims
Drug-coated balloon catheters (DCB) are a new clinical treatment modality for coronary and peripheral artery disease. The goal of the consensus group is to develop recommendations for the ...clinical use of DCB based on randomized clinical trials and the best available clinical evidence. The present paper gives an update on the recommendations against the background of a variety of new data published since the first paper was presented.
Methods and results
The general concept of our recommendations for the coronary use of DCB includes the preparation of the lesion to facilitate drug delivery and to estimate the need for stent implantation, especially after relevant dissections. Lesion preparation includes conventional angioplasty. In more complex lesions, additional treatments and imaging or functional measurements are helpful. In case of no flow-limiting dissection and an acceptable but not stent-like primary result, DCB use without additional stent implantation may be considered. The proposed advantages of the DCB only concept over a direct stent approach include reduced restenosis rates in indications where DES show limited efficacy, the reduction of DAPT especially in patients with contraindications for prolonged DAPT, and the option of leaving no foreign object behind resulting in vascular restoration with potentially plaque regression instead of neo-atherosclerosis.
Conclusions
DCB allow for local drug delivery in endovascular therapy leaving no permanent implant behind.
Aims Because of its high spatial resolution and tissue contrast, magnetic resonance imaging (MRI) was used to assess cardiac structure and function in a large population of patients with acute ...myocardial infarction (AMI). Methods and results One hundred and ten patients were studied by MRI 6.1±2.2 days after AMI. Infarct size (IS), persistent microvascular obstruction (PMO), left and right ventricular (LV/RV) volumes, and functions were measured. The same MRI measurements were repeated in 89 patients after a mean follow-up period of 225±92 days. IS was 11.9±7.3% of total LV muscle mass. PMO was detected in 51/110 (46.4%) patients and comprised 15.6±8.5% of IS and 2.8±2.3% of LV muscle mass. Papillary muscle infarct was seen in 26%, RV infarction in 16%, pericarditis in 40%, and pericardial effusion in 66% of the patients. During follow-up, there were 16 major adverse cardiac events (MACE) including seven deaths. IS, PMO, and amount of transmural infarction were predictive for LV adverse remodelling defined as >20% increase in LV end-diastolic volume. Multivariable analysis revealed LV end-diastolic volume, LV ejection fraction, and PMO as significant predictors for the occurrence of MACE. Conclusion MRI is a highly sensitive and reliable tool to detect morphologic and functional sequelae of AMI providing baseline MRI parameters with relevant predictive power for LV adverse remodelling and occurrence of MACE.
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