Objectives The purpose of this article is to report early and mid-term outcomes of the ACCESS-EU study (ACCESS-Europe A Two-Phase Observational Study of the MitraClip System in Europe), a European ...prospective, multicenter, nonrandomized post-approval study of MitraClip therapy (Abbott Vascular, Inc., Santa Clara, California). Background MitraClip has been increasingly performed in Europe after approval; the ACCESS-EU registry provides a snapshot of the real-world clinical demographic data and outcomes. Methods A total of 567 patients with significant mitral valve regurgitation (MR) underwent MitraClip therapy at 14 European sites. Mean logistic European System for Cardiac Operative Risk Evaluation at baseline was 23.0 ± 18.3; 84.9% patients were in New York Heart Association functional class III or IV, and 52.7% of patients had an ejection fraction ≤40%. Results The MitraClip implant rate was 99.6%. A total of 19 patients (3.4%) died within 30 days after the MitraClip procedure. The Kaplan-Meier survival at 1 year was 81.8%. Intensive care unit and hospital length of stay was 2.5 ± 6.5 days and 7.7 ± 8.2 days, respectively. Single leaflet device attachment was reported in 27 patients (4.8%). There were no MitraClip device embolizations. Thirty-six subjects (6.3%) required mitral valve surgery within 12 months after the MitraClip implant procedure. There was improvement in the severity of MR at 12 months, compared with baseline (p < 0.0001), with 78.9% of patients free from MR, severity of >2+ at 12 months. At 12 months, 71.4% of patients had New York Heart Association functional class II or class I. Six-min-walk-test improved 59.5 ± 112.4 m, and Minnesota-living-with-heart-failure score improved 13.5 ± 20.5 points. Conclusions In the real-world, post-approval experience in Europe, patients undergoing the MitraClip therapy are high-risk, elderly patients, mainly affected by functional MR. In this patient population, the MitraClip procedure is effective with low rates of hospital mortality and adverse events.
Abstract Computed tomography (CT) plays an important role in the workup of patients who are candidates for implantation of a catheter-based aortic valve, a procedure referred to as transcatheter ...aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR). Contrast-enhanced CT imaging provides information on the suitability of the peripheral access vessels to accommodate the relatively large sheaths necessary to introduce the prosthesis. CT imaging also provides accurate dimensions of the ascending aorta, aortic root, and aortic annulus which are of importance for prosthesis sizing, and initial data indicate that compared with echocardiographic sizing, CT-based sizing of the prosthesis may lead to better results for postprocedural aortic valve regurgitation. Finally, CT permits one to predict appropriate fluoroscopic projections which are oriented orthogonal to the aortic valve plane. This consensus document provides recommendations about the use of CT imaging in patients scheduled for TAVR/TAVI, including data acquisition, interpretation, and reporting.
Numerous patients are treated with the MitraClip, although they do not fulfill the stringent inclusion criteria of the Endovascular Valve Edge-to-Edge Repair Study (EVEREST) trials. The outcome of ...those patients is not well known. Therefore, we compared the long-term outcome after MitraClip treatment between patients who matched (group 1) and did not match (group 2) the EVEREST criteria. One hundred thirty-four consecutive patients were treated from September 2009 to July 2012: 59 patients (44%) in group 1 versus 75 patients (56%) in group 2. Investigated end points were acute procedural success (for group 1 vs 2: 97% vs 95%; p = 0.694), all-cause mortality (28% vs 27%; p = 0.656), reintervention (RI) rate (11% vs 37%; p = 0.010), and improvement in mitral regurgitation (MR) (−1.3 ± 1 vs −1.5 ± 1, p = 0.221) and in New York Heart Association functional class (−0.7 ± 1 vs −0.9 ± 0.8, p = 0.253) during the follow-up of 33 months (27.9 to 38.3). The morphologic extent of a flail leaflet was an independent predictor for RI. In conclusion, although the overall outcome was comparable between both groups, recurrent symptomatic MR with need for RI was higher in group 2, mainly because of complex valve pathologies: especially flail width >15 mm and gap ≥10 mm. Improvements in the interventional strategy are warranted for reducing the need for RI in patients with primary MR.
This report describes the 12-month outcomes of the a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe (ACCESS-EU postapproval study of MitraClip therapy) ...with respect to preprocedural left ventricular ejection fraction (LVEF). Transcatheter deployment of the MitraClip device may be considered for patients who are not suitable for conventional surgery. A total of 567 patients with significant mitral regurgitation (MR) underwent MitraClip therapy. Of those, 393 had functional MR (FMR) and were subdivided by preprocedural LVEF (A: 10% to 20%, B: >20% to 30%, C: >30% to 40%, D: >40%). Procedural safety and efficacy and treatment outcomes including MR grade, New York Heart Association (NYHA) functional class, 6-minute walk test, and the Minnesota Living with Heart Failure Questionnaire were analyzed at baseline, 30 days, and 12 months. Baseline mean logistic EuroSCORE was 25 ± 19; 87% of patients were in NYHA classes III or IV (A: 96%, B: 83%, C: 90%, D: 86%). There was no incidence of death or stroke intraprocedurally. Eleven patients died within 30 days with no differences among subgroups. Kaplan–Meier survival at 12 months was 81.8% (A: 71%, B: 79%, C: 87%, D: 86%). There was a significant improvement in MR severity at 30 days and 12 months (p <0.0001). At 12 months, all subgroups experienced similar improvements in NYHA class, 6-minute walk test, and Minnesota Living with Heart Failure Questionnaire. This real-world registry reports promising results of MitraClip therapy in patients with FMR. In conclusion, the low rates of hospital mortality and adverse events in patients with FMR—even in patients with severely reduced LVEF—provide additional evidence of substantial benefits after MitraClip implantation.
Prognostic Value of Coronary Computed Tomographic Angiography for Prediction of Cardiac Events in Patients With Suspected Coronary Artery Disease Martin Hadamitzky, Barbara Freißmuth, Tanja Meyer, ...Franziska Hein, Adnan Kastrati, Stefan Martinoff, Albert Schömig, Jörg Hausleiter Although coronary computed tomography angiography (CCTA) is an attractive tool to rule out coronary artery stenoses, only limited data are available concerning its prognostic value. In a large series of consecutive patients undergoing CCTA, who were followed up for a period of 18 months, event rates were significantly higher among patients with obstructive coronary artery disease as compared with patients without stenoses on computed tomography. The odds ratios were as high as 20 for severe cardiac events among patients with obstructive disease, and the annual event rate among patients without obstructive disease was significantly lower (0.1%) than predicted by the Framingham score. The Editors' Page in this issue of iJACC welcomes CCTA into the prognosis club of imaging strategies.
Abstract Over the last few years, computed tomography (CT) has developed into a standard clinical test for a variety of cardiovascular conditions. The emergence of cardiovascular CT during a period ...of dramatic increase in radiation exposure to the population from medical procedures and heightened concern about the subsequent potential cancer risk has led to intense scrutiny of the radiation burden of this new technique. This has hastened the development and implementation of dose reduction tools and prompted closer monitoring of patient dose. In an effort to aid the cardiovascular CT community in incorporating patient-centered radiation dose optimization and monitoring strategies into standard practice, the Society of Cardiovascular Computed Tomography has produced a guideline document to review available data and provide recommendations regarding interpretation of radiation dose indices and predictors of risk, appropriate use of scanner acquisition modes and settings, development of algorithms for dose optimization, and establishment of procedures for dose monitoring.
Summary Background Comparative assessment of clinical outcomes after use of drug-eluting stents versus bare-metal stents for treatment of aortocoronary saphenous vein graft lesions has not been ...undertaken in large randomised trials. We aimed to undertake a comparison in a randomised trial powered for clinical endpoints. Methods In this randomised superiority trial, patients with de-novo saphenous vein graft lesions were assigned by computer-generated sequence (1:1:1:3) to receive either drug-eluting stents (one of three types: permanent-polymer paclitaxel-eluting stents, permanent-polymer sirolimus-eluting stents, or biodegradable-polymer sirolimus-eluting stents) or bare-metal stents. Randomisation took place immediately after crossing of the lesion with a guidewire, and was stratified for each participating centre. Investigators assessing data were masked to treatment allocation; patients were not masked to allocation. The primary endpoint was the combined incidence of death, myocardial infarction, and target lesion revascularisation at 1 year. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov , number NCT00611910. Findings 610 patients were allocated to treatment groups (303 drug-eluting stent, 307 bare-metal stent). Drug-eluting stents reduced the incidence of the primary endpoint compared with bare-metal stents (44 15% vs 66 22% patients; hazard ratio HR 0·64, 95% CI 0·44–0·94; p=0·02). Target lesion revascularisation rate was reduced by drug-eluting stents (19 7% vs 37 13% patients; HR 0·49, 95% CI 0·28–0·86; p=0·01). No significant differences were seen between drug-eluting stents and bare-metal stents regarding all-cause mortality (15 5% vs 14 5% patients; HR 1·08, 95% CI 0·52–2·24; p=0·83), myocardial infarction (12 4% vs 18 6%; HR 0·66, 95% CI 0·32–1·37; p=0·27), or definite or probable stent thrombosis (2 1% in both groups; HR 1·00, 95% CI 0·14–7·10; p=0·99). Interpretation In patients undergoing percutaneous coronary intervention for de-novo saphenous vein graft lesions, drug-eluting stents are the preferred treatment option because they reduce the risk of adverse events compared with bare-metal stents. Funding Deutsches Herzzentrum.
Improved Noninvasive Assessment of Coronary Artery Bypass Grafts With 64-Slice Computed Tomographic Angiography in an Unselected Patient Population Tanja S. Meyer, Stefan Martinoff, Martin ...Hadamitzky, Albrecht Will, Adnan Kastrati, Albert Schömig, Jörg Hausleiter This prospective evaluation investigates the diagnostic accuracy of 64-slice computed tomography angiography (CTA) for detection of stenoses in 418 bypass grafts in 138 “real-world” patients. When compared with invasive angiography, CTA resulted in a sensitivity of 97%, specificity of 97%, and positive and negative predictive values of 93% and 99%, respectively. Although the evaluability of bypass grafts was significantly lower in patients with arrhythmias or heart rates ≥65 beats/min, no significant differences were detected in the diagnostic accuracy for the assessment of evaluable bypass grafts. Sixty-four–slice CTA is a reliable and accurate method for the noninvasive evaluation of symptomatic patients after bypass surgery.
Objectives This study sought to examine patterns of follow-up invasive coronary angiography (ICA) and revascularization (REV) after coronary computed tomography angiography (CCTA). Background CCTA is ...a noninvasive test that permits direct visualization of the extent and severity of coronary artery disease (CAD). Post-CCTA patterns of follow-up ICA and REV are incompletely defined. Methods We examined 15,207 intermediate likelihood patients from 8 sites in 6 countries; these patients were without known CAD, underwent CCTA, and were followed up for 2.3 ± 1.2 years for all-cause mortality. Coronary artery stenosis was judged as obstructive when ≥50% stenosis was present. A multivariable logistic regression was used to estimate ICA use. A Cox proportional hazards model was used to estimate all-cause mortality. Results During follow-up, ICA rates for patients with no CAD to mild CAD according to CCTA were low (2.5% and 8.3%), with similarly low rates of REV (0.3% and 2.5%). Most ICA procedures (79%) occurred ≤3 months of CCTA. Obstructive CAD was associated with higher rates of ICA and REV for 1-vessel (44.3% and 28.0%), 2-vessel (53.3% and 43.6%), and 3-vessel (69.4% and 66.8%) CAD, respectively. For patients with <50% stenosis, early ICA rates were elevated; over the entirety of follow-up, predictors of ICA were mild left main, mild proximal CAD, respectively, or higher coronary calcium scores. In patients with <50% stenosis, the relative hazard for death was 2.2 (p = 0.011) for ICA versus no ICA. Conversely, for patients with CAD, the relative hazard for death was 0.61 for ICA versus no ICA (p = 0.047). Conclusions These findings support the concept that CCTA may be used effectively as a gatekeeper to ICA.
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