Frequency, Impact, and Predictors of Access Complications With Plug-Based Large-Bore Arteriotomy Closure - A Patient-Level Meta-Analysis.

BACKGROUND/PURPOSE: The MANTA is a dedicated plug-based large-bore vascular closure device (VCD) providing safe hemostasis in most patients, but data on the clinical impact and mechanisms of MANTA related complications are limited. This study sought to determine the frequency, impact and predictors of MANTA-related access complications. METHODS/MATERIALS: This patient-level meta-analysis included data from 2 medical device approval studies and 1 post-approval registry. The primary endpoint was the composite of major and minor access complications. Technical success was defined as hemostasis with MANTA closure device without need for vascular surgery or stenting. RESULTS: Eight hundred ninety-one patients (mean age 80) underwent transcatheter aortic valve replacement (n = 814), endovascular aortic repair (n = 71), balloon aortic valvuloplasty (n = 4) or mechanical circulatory support (n = 2). Technical success was 96.4% and median time to hemostasis was 31 (interquartile range: 17-76) seconds. The primary endpoint occurred 9.1% and bailout vascular surgery or stenting was necessary in 32 patients (3.6%). Female gender (OR: 2.63, CI: 1.46-4.73, p = 0.001), left femoral access (OR: 2.18, CI: 1.17-4.06, p = 0.015) and unfavorable arteriotomy phenotype (combination of a small femoral artery diameter with a deep arteriotomy; OR 2.27: 1.26-4.10, p = 0.006) independently predicted access complications. Access complications most often consisted of vessel dissection, stenosis or occlusion and predominantly occurred in patients with an unfavorable arteriotomy phenotype. CONCLUSIONS: Large-bore arteriotomy closure with MANTA VCD provided fast and safe hemostasis with an acceptable complication rate. Refined procedure planning and risk-stratification may further improve MANTA VCD performance.

Data on plug-based large-bore arteriotomy vascular closure device related access complications.

This article provides supplementary tables and figures to the research article: Frequency, Impact and Predictors of Access Complications with Plug-Based Large-Bore Arteriotomy Closure - A patient level meta-analysis [1]. The data provide insight in the type and management of access complications related to the plug-based MANTA vascular closure device (VCD) for large-bore catheter-based cardiovascular interventions. Since MANTA is mostly used in transcatheter aortic valve replacement (TAVR) procedures, this article also contains a sub-group analysis on TAVR procedures using contemporary valve-platforms. Further, data describing MANTA hemostasis times and mortality causes are included. For this dataset, individual patient data were derived from a European and a North American device approval study (the Conformite Européene [CE] mark study and the investigational device exemption SAFE-MANTA study [2,3]) in addition to a post-approval registry (the MARVEL registry [4]) covering a total of 891 patients who were enrolled between 2015 and 2019 across 28 investigational sites. Eligibility criteria were most stringent in the SAFE MANTA study (38% of patients) whereas the MARVEL registry applied liberal and only relative exclusion criteria (56% of patients). A total of 78 Roll-in cases (i.e. first or second time operator use of the MANTA VCD) who were excluded from analysis in SAFE MANTA were included in the present to evaluate a potential learning curve effect. Therefore, this dataset reflects the largest study population undergoing arteriotomy closure with the MANTA VCD by operators at various levels of experience, which can be valuable to further build on research regarding percutaneous large-bore arteriotomy management.

TAVR for severe aortic stenosis and papillary fibroelastoma in a high-risk setting.

Papillary fibroelastomas (PFE) are rare benign cardiac tumours mainly originating on aortic and mitral valvular surfaces. Management is individualised, but most recommend surgical excision due to thromboembolic risk. We report a 75-year-old man with symptomatic severe aortic stenosis compounded by PFE. Redo sternotomy aortic valve replacement was deferred in favour of the trans-apical (TAVR) approach. This report highlights, for the first time, the application of TAVR as a strategy for aortic valve stenosis and PFE to mitigate risk posed by injury to patent internal mammary arterial graft in close proximity to the manubrium, and complications due to the patient's multiple comorbidities.

Predictors of Successful Hybrid-Approach Chronic Total Coronary Artery Occlusion Stenting: An Improved Model With Novel Correlates.

OBJECTIVES: The aim of this study was to develop a hybrid approach-specific model to predict chronic total coronary artery occlusion (CTO) percutaneous coronary intervention success, useful for experienced but not ultra-high-volume operators. BACKGROUND: CTO percutaneous coronary intervention success rates vary widely and have improved with the "hybrid approach," but current predictive models for success have major limitations. METHODS: Data were obtained from consecutively attempted patients from 7 clinical sites (9 operators, mean annual CTO volume 61 ± 17 cases). Angiographic analysis of 21 lesion variables was performed centrally. Statistical modeling was performed on a randomly designated training group and tested in a separate validation cohort. The primary outcome of interest was technical success. RESULTS: A total of 436 patients (456 lesions) met entry criteria. Twenty-five percent of lesions had prior failed percutaneous coronary interventions at the site. The right coronary artery was the most common location (56.4%), and mean occlusion length was 24 ± 20 mm. The initial approach was most often antegrade wire escalation (70%), followed by retrograde (22%). Success was achieved in 79.4%. Failure was most closely correlated with presence of an ambiguous proximal cap, and in the presence of an ambiguous proximal cap, specifically defined collateral score (combination of Werner and tortuosity scores) and retrograde tortuosity. Without an ambiguous proximal cap, poor distal target, occlusion length >10 mm, ostial location, and 1 operator variable contributed. Prior failure, and Werner and tortuosity scores alone, were only weakly correlated with outcomes. The basic 7-item model predicted success, with C statistics of 0.753 in the training cohort and 0.738 in the validation cohort, the later superior (p < 0.05) to that of the J-CTO (Multicenter CTO Registry of Japan) (0.55) and PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) (0.61) scores. CONCLUSIONS: Success can be reasonably well predicted, but that prediction requires modification and combination of angiographic variables. Differences in operator skill sets may make it challenging to create a powerful, generalizable, predictive tool.

Incidence and characteristics of inappropriate and false-positive cardiac catheterization laboratory activations in a regional primary percutaneous coronary intervention program.

BACKGROUND: The implementation of regional primary percutaneous coronary intervention (PCI) programs has been critical in achieving timely intervention in patients with ST-segment elevation myocardial infarction (STEMI). However, 1 consequence has been inappropriate and false-positive cardiac catheterization laboratory (CCL) activations where either angiography is cancelled or no culprit lesion is found, respectively. METHODS: We performed a retrospective cohort study of 1,391 patients referred for primary PCI to a single academic center from November 2007 to August 2013. Our purpose was to determine the incidence and characteristics of inappropriate and false-positive CCL activations by emergency departments (EDs) or emergency medical services (EMS), and the effect of a quality improvement (QI) initiative to reduce such events implemented during this period. RESULTS: During the study period, there were 37 (2.7%) inappropriate and 206 (14.8%) false-positive CCL activations. There was no difference between the ED and EMS rates of inappropriate activation (2.1% vs 3.8%, P = .06). Among patients who proceeded to angiography, the false-positive rate for ED CCL activation was 16.9% compared to 11.5% for EMS (P = .01). Although there was no difference comparing inappropriate activation or false-positive rates before and after the QI initiative (P = .22), we observed an encouraging year-to-year trend. CONCLUSIONS: Emergency department activation of the CCL is associated with a higher false-positive rate than activation by EMS. Further QI efforts are required to improve communication between interventional cardiologists, emergency physicians, and paramedics to improve the specificity of CCL activation while taking care not to sacrifice sensitivity and rapidity of diagnosis.

Transcatheter mitral valve implantation (TMVI) using the Edwards FORTIS device.

Transcatheter aortic valve implantation (TAVI) has demonstrated the feasibility of treating valvular heart disease with transcatheter therapy. On the back of this success, various transcatheter concepts are being evaluated to treat other valvular disease, especially mitral regurgitation (MR). The concepts currently approved to treat MR replicate surgical mitral valve repair. However, most of them cannot eliminate MR completely. Similar to TAVI, a transcatheter mitral valve implantation may provide a valuable alternative. The FORTIS transcatheter mitral valve (Edwards Lifesciences, Irvine, CA, USA) is a self-expanding device implanted via a transapical approach. We describe our experience and early results in the first five patients treated on compassionate grounds. We also describe the details of the device, selection criteria and technical details of implantation.