Fabien Picard

Bioresorbable Vascular Scaffold During ST-Elevation Myocardial Infarction: A Systematic Review.

BACKGROUND The bioresorbable vascular scaffold (BVS) represents a novel technology designed to overcome the long-term limitations of metallic coronary stent implantation in percutaneous coronary intervention. In this context, primary percutaneous coronary intervention in ST-elevation myocardial infarction (STEMI) could be a preferred scenario for BVS implantation. Nevertheless, data on efficacy and safety are lacking in this specific subset of patients. METHODS We conducted a systematic review to examine the safety and efficacy of BVS use in STEMI patients. We searched PubMed, EMBASE, and the Cochrane Library through June 2016 for studies that included outcome data for BVS implantation in STEMI patients. Outcomes of interest included cardiac death, myocardial infarction, scaffold thrombosis, target lesion revascularization, restenosis, and composite end points. RESULTS We identified 9 eligible articles, which included 1 randomized controlled trial and 8 cohort studies (5 controlled), for a total of 846 patients. These studies varied in size (11-290) and follow-up duration (1-24 months). The incidence of major cardiac events ranged from 1.1% to 13%, with no statistically significant difference between BVS and control groups in studies that included a comparison group. Although there was a trend toward an increase in scaffold thrombosis in the largest controlled registries, no statistically significant increase was found. CONCLUSIONS Current clinical data are scarce, but suggest that BVS might represent a reasonable alternative to drug-eluting stents in STEMI patients. The lack of large randomized controlled trials with extended follow-up periods and the scaffold thrombosis signal are limiting factors for widespread use before additional large-scale trials are available.

Contemporary use of drug-coated balloons in coronary artery disease: Where are we now?

The drug-coated balloon (DCB) has emerged as an additional tool in the arsenal of interventional cardiology devices; it delivers antiproliferative drugs to local arterial tissue by single prolonged coated balloon angioplasty inflation, and prevents restenosis, leaving no implant behind. This strategy theoretically decreases the risk of late inflammatory response to device components, without preventing positive remodelling. DCBs, when used carefully and with a good technique, may have a role in the treatment of lesion subsets, such as in-stent restenosis, small vessel disease or side branch bifurcations, in which the implantation of a drug-eluting stent is not desirable or is technically challenging. Using the latest evidence regarding the effectiveness of the currently available DCBs, this review will discuss the rationale for DCB use, and the effectiveness of DCBs in different clinical and lesion settings, and will give practical tips for their correct use in everyday clinical practice.

From tricuspid to double orifice Morphology: Percutaneous tricuspid regurgitation repair with the MitraClip device in congenitally corrected-transposition of great arteries.

Edge to edge transcatheter mitral valve repair with MitraClip (Abbott Vascular, Menlo Park, CA) is increasing for high‐risk surgical patients with significant mitral regurgitation. Patients with congenitally corrected transposition of the great arteries (CCTGA) presenting with tricuspid valve regurgitation of a systemic right ventricle may represent particularly challenging candidates for MitraClip given their anatomy. We report the case of a 67‐year‐old gentleman with CCTGA and severe tricuspid regurgitation who was referred for MitraClip implantation after heart team consensus. Successful implantation of one clip was performed, achieving a significant reduction of the regurgitation. Similarly, favorable findings were confirmed at 6 months, 1 and 2 years follow‐up and the patient had no recurrent heart failure admissions after 2‐year follow‐up. We describe the technical considerations and the importance of 3D‐transoesophageal echocardiography for performing the MitraClip of a trileaflet systemic atrioventricular valve.

Triple Antithrombotic Therapy in Atrial Fibrillation Patients With an Indication for Oral Anticoagulation Undergoing Percutaneous Coronary Intervention A Case-Based Review of the Current Evidence

Atrial fibrillation (AF) is a growing problem, affecting 5.2 million people in the United States in 2010, with a prevalence that is expected to increase to over 12 million by 2030.1,2 The standard of care for stroke prevention in such patients at increased risk, as indicated by a congestive heart failure, hypertension, age ≥75 y (doubled), diabetes mellitus, prior stroke or TIA or thromboembolism (doubled), vascular disease, age 65–74 y, sex category (CHA2DS2-VASc) score3 ≥1, is anticoagulation with a vitamin K antagonist (VKA) or novel oral anticoagulant (NOAC).4 In addition, patients with AF have a high risk of concomitant coronary artery disease (CAD), and when percutaneous coronary intervention (PCI) is required, treatment with aspirin and a platelet P2Y12 receptor inhibitor also becomes indicated.5–7 In such cases, the risk of thromboembolic events and stent thrombosis (ST) after PCI must be weighed against the risk of major bleeding.8–11 Newer, more potent antiplatelet therapy and novel anticoagulants have emerged, thus, making the decision of triple therapy (TT) even more challenging. The optimal antithrombotic therapy for AF patients undergoing PCI is as yet unknown. For many primary care physicians and general cardiologists, the duration, benefits, and bleeding risks of TT in AF patients is unclear. We describe a clinical case of a patient with AF undergoing PCI and discuss medical management for such patients with an emphasis on the recent available data. A 77-year-old woman with permanent AF, diabetes mellitus, dyslipidemia, who was receiving warfarin to prevent stroke presented to the outpatient clinic with progressive chest pain for the past 3 months. She was a former smoker and was carefully taking her medication, which included β-blockers, statins, metformin, and warfarin, with stable international normalized ratio (INR) results. Her ECG …

Early Multiple Coronary Micro Aneurysms After Bioresorbable Vascular Scaffold Implantation

Bioresorbable vascular scaffold (BVS) is a novel technology designed to overcome the long-term limitations of permanent metallic stent implantation in percutaneous coronary intervention. However, little is known about the development of coronary aneurysms after the use of BVSs, and additional experience is needed to establish the entire spectrum of complications related to the use of these emerging materials. We hereby report an unusual case of early multiple coronary artery micro aneurysms formation after BVS implantation.

Simplifying the assessment of coronary artery stenosis by enhancing instantaneous wave free ratio

Background Instantaneous wave free ratio (iFR) does not require adenosine, but has a relatively wide intermediate range where functional assessment remains inconclusive. In this pilot study, we sought to enhance iFR through with the use of intracoronary (IC) saline (iFRs) and contrast media (iFRc) and determine whether these techniques correlated well with fractional flow reserve (FFR). Methods Patients with coronary artery stenosis (CAS) associated with an iFR in the intermediate zone (≥0.86 and ≤0.93) were prospectively assessed with resting distal coronary pressure/aorta pressure (Pd/Pa), iFR, iFRs, iFRc and FFR. Results A total of 40 coronary lesions were studied (40 patients). Pearson correlation coefficients for FFR and iFR, FFR and iFRs, FFR and iFRc were respectively: 0.57 (P=0.0002), 0.80 (P<0.0001) and 0.77 (P<0.0001). Receiver-operating characteristic (ROC) curve analysis showed similar area under the curve (AUC) of iFRs and iFR [0.90 (95% CI: 0.76-1) vs. 0.89 (95% CI: 0.79-0.99), P=0.89]. Youdens index established cut-off values of ≤0.90 for iFR (sensitivity =91%, specificity =74%) and ≤0.78 for iFRs (sensitivity =73%, specificity =100%). In contrast, the AUC of iFRc was superior to the AUC of iFR [0.99 (95% CI: 0.98-1), P=0.049]. iFRc showed excellent accuracy and established cut-off values of ≤0.81 in predicting an FFR value of ≤0.80 (sensitivity =100%, specificity =93%). Conclusions When iFR is in the intermediate zone, functional assessment of CAS by iFR is enhanced with the use of contrast media but not saline. This pilot study could be hypothesis generating for further study to enhance iFR specificity and sensibility.

Clinical outcomes of bioresorbable vascular scaffold to treat all-comer patients. Are patients with acute coronary syndrome better candidate for bioresorbable vascular scaffold?

BACKGROUND Scaffold thromboses (ST) and adverse events and have been associated with bioresorbable vascular scaffolds (BVS) at long-term, but their mechanism remains unclear. We sought to evaluate patient and lesion characteristics associated with mid- to long-term outcomes in patients treated with BVS. METHODS This is an observational single-center, single-arm, retrospective study evaluating the performance of BVS in an all-comer population, including complex lesions (chronic total occlusions, long lesions), small vessels, and acute coronary syndromes (ACS). RESULTS From May 2013 to June 2015, we included 482 patients (580 lesions) that were treated with BVS implantation including 71.2% treated for ACS in the present analysis. Mean follow-up period was 816.2 ± 242.6 days. The primary endpoint was device oriented cardiac events (DOCE), defined as a composite of target-lesion revascularization (TLR), ST, target vessel myocardial infarction (TVMI) and cardiac death. Using Kaplan-Meier methods, the DOCE and ST rates at 36 months were 9.4% and 2.3%, respectively. No ST occurred between 2 and 3 years and ST occurred after 3 years, in one patient. Using multivariate analysis, ACS was the only significant predictor of lower rates of DOCE (p = 0.04, HR: 0.47, 95% CI: 0.23-0.96). CONCLUSIONS In this large all-comers real-world cohort, lesions treated with BVS had non-negligible rates of DOCE and ST, in line with previous published randomized trials. The occurrence of very late event was very low after 24 months. ACS patients had lower rates of DOCE.

Long-term outcomes of bioresorbable vascular scaffold in ST-elevation myocardial infarction

Abstract Background: Bioresorbable vascular scaffolds (BVS) implantation in selected patients with stable angina has been demonstrated feasible and safe. However, limited data are currently available on long-term outcomes after BVS implantation for ST-elevation myocardial infarction (STEMI). Therefore, we sought to assess the safety, efficacy and long-term results of BVS implantation in STEMI patients. Methods: Retrospective review of all STEMI patients treated with the Absorb® BVS (Abbott Vascular, Santa Clara, CA) or conventional drug eluting stent (DES) between 1 April 2013 and 30 March 2014. Primary outcomes were procedural success, device thrombosis and device-oriented composite endpoint (DOCE) including cardiac death, target vessel myocardial infarction and target lesion revascularization. The study included 54 BVS patients and 121 DES patients. Results: Patients were slightly younger in the BVS group (60 vs. 63 years old, p = .03). Other baseline characteristics were comparable between the two groups. Procedural success was achieved in all patients. Median follow-up was 901 days and 849 days for BVS and DES patients, respectively (p = .01). The cumulative incidence of DOCE was not significantly different between the BVS and DES groups (7.5% vs. 9.1%, hazard ratio [HR]: 0.74 [95% confidence interval (CI): 0.26–2.2], p = NS). Rate of probable/definite device thrombosis were not statistically different between both groups (3.7% vs. 3.3%, p = NS). Conclusions: The results of this single-centre retrospective study, one of the first assessing long-term safety and efficacy of BVS in STEMI, seems reassuring with similar long-term results as compared with patients treated with conventional DES.

Bioresorbable vascular scaffold to treat in‐stent restenosis: Single‐center experience

AIMS The management of patients with in-stent restenosis (ISR) is still a major clinical challenge even in the era of drug-eluting stents (DES). Recent studies have demonstrated acceptable clinical outcomes for the everolimus-eluting bioresorbable vascular scaffold (BVS) ABSORB™ in patients with stable coronary artery disease but data are scarce on its use in patients with ISR. We report the long-term results of our preliminary experience with this novel approach at our institution. METHODS AND RESULTS We investigated the safety and efficacy of BVS implantation to treat ISR. 34 consecutive patients (37 lesions) underwent PCI for ISR with BVS implantation between May 2013 and June 2015 at our institution and were included in the current analysis. Follow-up was available in 91.9% of the patients. Mean follow-up period was 801.9 ± 179 days. One patient had definite scaffold thrombosis (ScT) 2 months after stent implantation which was treated with DES. Five patients (six lesions) experienced target lesion revascularization (TLR). The composite endpoint rate of TLR, ScT, myocardial infarction, and death occured in 6/37 lesions at follow-up (16.2%). CONCLUSIONS These real-world data using BVS in patients with ISR demonstrates that ISR treatment with ABSORB™ BVS is feasible but could have slightly higher target lesion failure rates as compared to DES. This proof of concept could be hypothesis-generating for larger randomized controlled studies.

Everolimus-eluting bioresorbable vascular scaffold implantation to treat saphenous vein graft disease, single-center initial experience

AIMS Recent studies have shown favorable outcomes with everolimus-eluting bioresorbable vascular scaffold (BVS) in patients with stable coronary artery disease. Data on the use of BVS in saphenous vein graft disease (SVG) is currently lacking. METHODS AND RESULTS A total of 10 consecutive patients (13 lesions, including 6 in-stent restenosis) who underwent BVS for SVG disease between May 2013 and June 2015 at a tertiary care institution were included. Median follow-up period was 874 (720-926) days. One patient had scaffold thrombosis (ScT) 15 months after implantation, which was treated medically. Another patient had target lesion revascularization (TLR) in two different lesions, where BVS was used to treat in-stent restenosis. The composite endpoint of TLR, ScT, target vessel myocardial infarction, and cardiac death, was reached in two patients CONCLUSIONS: This first real-world data on the use of the ABSORB™ BVS in patients with SVG disease shows that its implantation is technically feasible. The observed rate of target lesion revascularization was similar to those observed with drug-eluting stents in similar settings. Larger studies are required to better define the optimal use of BVS to treat SVG disease.