iFR uncovers profound but mostly reversible ischemia in CTOs and helps to optimize PCI results.

OBJECTIVES: The study aimed to demonstrate through instant wave-free ratio (iFR) measurements that myocardium distal to a chronic total occlusion (CTO) is ischemic, that ischemia is reversible by PCI, and that iFR assessment after PCI can be used to optimize PCI results. BACKGROUND: The greatest benefit of revascularization is found in patients with low fractional flow reserve. In patients with CTOs, iFR measurement may be more appropriate to evaluate ischemia as it does not require maximal microvascular vasodilation, which may be hampered by microvascular dysfunction. METHODS: The iFR was measured in 81 CTO patients, both pre- and post-PCI in 63 patients, and only post-PCI in the following 18 patients. A pressure wire pullback was performed post-PCI if iFR ≤0.89. RESULTS: The first 63 patients all had significant ischemia distal to the CTO with a median iFR of 0.33 [0.22; 0.44], improving significantly post-PCI to a median iFR of 0.93 [0.89;0.96] (p < .001). In the complete cohort, the median iFR post-PCI was 0.93 [0.86;0.96] but still ≤0.89 in 23 patients (30%). 12 of these patients had further PCI optimization because of a residual focal pressure gradient on pullback, after which only two had a final iFR ≤0.89. CONCLUSIONS: In CTO patients with an indication for PCI, iFR consistently demonstrated profound myocardial ischemia. Successful PCI immediately relieved ischemia in 70% of patients. In the remaining 30% of cases, a manual iFR pullback proved helpful in guiding further optimization of the PCI result.

Fourth generation e-cigarette vaping induces transient lung inflammation and gas exchange disturbances: results from two randomized clinical trials.

When heated by an electronic cigarette, propylene glycol and glycerol produce a nicotine-carrying-aerosol. This hygroscopic/hyperosmolar aerosol can deposit deep within the lung. Whether these deposits trigger local inflammation and disturb pulmonary gas exchanges is not known. The aim of this study was to assess the acute effects of high-wattage electronic cigarette vaping with or without nicotine on lung inflammation biomarkers, transcutaneous gas tensions, and pulmonary function tests in young and healthy tobacco smokers. Acute effects of vaping without nicotine on arterial blood gas tensions were also assessed in heavy smokers suspected of coronary artery disease. Using a single-blind within-subjects study design, 25 young tobacco smokers underwent three experimental sessions in random order: sham-vaping and vaping with and without nicotine at 60 W. Twenty heavy smokers were also exposed to sham-vaping (n = 10) or vaping without nicotine (n = 10) in an open-label, randomized parallel study. In the young tobacco smokers, compared with sham-vaping: 1) serum club cell protein-16 increased after vaping without nicotine (mean ± SE, -0.5 ± 0.2 vs. +1.1 ± 0.3 µg/l, P = 0.013) and vaping with nicotine (+1.2 ± 0.3 µg/l, P = 0.009); 2) transcutaneous oxygen tension decreased for 60 min after vaping without nicotine (nadir, -0.3 ± 1 vs. -15.3 ± 2.3 mmHg, P < 0.001) and for 80-min after vaping with nicotine (nadir, -19.6 ± 2.8 mmHg, P < 0.001). Compared with sham vaping, vaping without nicotine decreased arterial oxygen tension for 5 min in heavy-smoking patients (+5.4 ± 3.3 vs. -5.4 ± 1.9 mmHg, P = 0.012). Acute vaping of propylene glycol/glycerol aerosol at high wattage with or without nicotine induces airway epithelial injury and sustained decrement in transcutaneous oxygen tension in young tobacco smokers. Intense vaping conditions also transiently impair arterial oxygen tension in heavy smokers.

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

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.

Initial clinical experience with the GORE® CARDIOFORM ASD occluder for transcatheter atrial septal defect closure.

OBJECTIVES: To report the initial clinical experience with a novel atrial septal defect (ASD) closure device, the GORE® CARDIOFORM ASD Occluder (GCO). BACKGROUND: Transcatheter closure has become the treatment of choice for secundum ASD. A wide range of occluder devices are available, but concern has been raised about the risk of cardiac erosion associated with rigid devices and future access to the left atrium METHODS: Retrospective chart review of patients treated with the GCO at three Canadian centers. Primary outcomes were procedural success and residual shunting at follow-up, as well as 30-day major adverse events. Secondary outcomes included new onset atrial arrhythmias, wire frame fractures (WFF), and all cause mortality. Clinical, echocardiographic, procedural data, and follow-up outcome variables were collected in each participating hospital. RESULTS: Between February and December 2015, 26 patients (5 children and 21 adults) underwent transcatheter ASD closure with the GCO and were included in the study cohort. Procedural success was achieved in 22 of 26 patients (85%) and no major procedural complications were observed. Two patients (8%) presented new onset atrial tachyarrhythmia during early follow-up (0-30 days). Follow-up echocardiography (median of 119 days [IQR: 92-146]) demonstrated no residual shunt in all implanted patients. After a median clinical follow-up of 174 days (IQR: 135-239), one patient died of an unrelated cause, there were no documented major adverse cardiovascular events. Fluoroscopic imaging of the device was performed in 20 patients (91%), and WFF was noted in five cases. No clinical consequence or device dysfunction was observed in these patients. CONCLUSIONS: In this first-in-man multicenter study, the GCO was safe and effective for ASD closure, with no major adverse events or residual shunt at follow-up. © 2017 Wiley Periodicals, Inc.

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.

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.

Papillary muscle rupture without severe mitral regurgitation following percutaneous balloon mitral commissurotomy: a case report.

Background: Percutaneous transvenous mitral commissurotomy (PTMC) is the first-line therapy of clinically significant rheumatic mitral stenosis. While the procedure is generally safe, new onset or aggravation of mitral regurgitation (MR) may occur, mainly due to commissural splitting and, less frequently, to leaflet tear and chordal rupture. Papillary muscle rupture (PMR) is exceedingly rare in this setting. Case summary: A 74-year-old woman with a history of aortic valve replacement and prior rheumatic mitral commissurotomy presented for worsening exercise intolerance and exertional dyspnoea. Transthoracic echocardiography showed a mean pressure gradient of 10 mmHg and a mitral valve area of 1.0 cm², consistent with clinically significant mitral stenosis. Subsequent PTMC was complicated by anterolateral PMR. However, the resulting MR was unexpectedly only of mild-to-moderate severity. Because of residual mitral stenosis and persisting symptoms, surgical mechanical mitral valve replacement and tricuspid annuloplasty were performed 6 weeks after PTMC. Papillary muscle rupture was confirmed during surgery. Discussion: We herein describe the occurrence of PMR induced by PTMC; the resulting MR was unexpectedly of mild-to-moderate severity, as a result of extensive rheumatic lesions limiting valve mobility. This case challenges the dogma according to which PMR invariably leads to severe MR. This might not be necessarily the case when it occurs following PTMC.

ShOckwave ballooN or Atherectomy with Rotablation in calcified coronary artery lesions: Design and rationale of the SONAR trial.

BACKGROUND: The percutaneous treatment of calcified coronary lesions remains challenging and is associated with worse clinical outcomes. In addition, coronary artery calcification is associated with more frequent peri-procedural myocardial infarction. STUDY DESIGN AND OBJECTIVES: The ShOckwave ballooN or Atherectomy with Rotablation in calcified coronary artery lesions (SONAR) study is an investigator-initiated, prospective, randomized, international, multicenter, open label trial (NCT05208749) comparing a lesion preparation strategy with either shockwave intravascular lithotripsy (IVL) or rotational atherectomy (RA) before drug-eluting stent implantation in 170 patients with moderate to severe calcified coronary lesions. The primary endpoint is difference in the rate of peri-procedural myocardial infarction. Key secondary endpoints include rate of peri-procedural microvascular dysfunction, peri-procedural myocardial injury, descriptive study of IMR measurements in calcified lesions, technical and procedural success, interaction between OCT calcium score and primary endpoint, 30-day and 1-year major adverse clinical events. CONCLUSIONS: The SONAR trial is the first randomized controlled trial comparing the incidence of peri-procedural myocardial infarction between 2 contemporary calcium modification strategies (Shockwave IVL and RA) in patients with calcified coronary artery lesions. Furthermore, for the first time, the incidence of peri-procedural microvascular dysfunction after Shockwave IVL and RA will be evaluated and compared.

Subacute saphenous vein graft stent thrombosis due to unusual drug interaction: a case report.

Background: Stent thrombosis is a potentially lethal complication of coronary angioplasty and responsible for 20% of all post-angioplasty myocardial infarctions. Unusual causes may be overlooked and difficult to identify. Case summary: A 70-year-old male with history of triple aortocoronary bypass presented with acute inferolateral ST-segment elevation myocardial infarction (STEMI). Critical stenosis of the vein graft to the right coronary artery was revealed, and with the use of distal embolic protection device, successful angioplasty with stent was performed under double antiplatelet treatment with aspirin and ticagrelor. Two weeks later, he presented again at the emergency department with an acute inferolateral STEMI. Subacute stent thrombosis with complete occlusion of the stented vein graft was evident. Repeated balloon dilatations restored the flow stabilizing the patient; optical coherence tomography showed good stent expansion and apposition. Scrutinizing the patient's history, we discovered comedication with carbamazepine that is a CYP3A4 inducer and reduces ticagrelor's effect. Switching to prasugrel ensured potent antiplatelet treatment, and the patient was discharged 5 days later. The 6-month follow-up was uneventful and free of symptoms. Discussion: Stent thrombosis has dire consequences, and the precipitating factors should always be investigated. Inadequate platelet inhibition secondary to non-compliance to therapy or resistance and suboptimal stent expansion/apposition are its main causes. Drug interactions are an underrecognized factor that may significantly alter the potency of antiplatelet drugs and also lead to stent thrombosis; thus, treatment is essential to be tailored to each patient comedication.

Diagnostic Role of Incidental Premature Contractions During Doppler Echocardiography.

Cardiac sonographers often perceive premature beats as a limiting factor during echocardiography because they alter filling and contractility, and loops recorded during or after a premature contraction are often discarded. Here we present 2 cases in which the incidental occurrence of premature beats on Doppler echocardiography contributed to the diagnosis. (Level of Difficulty: Intermediate.).

The Resorbable Magnesium Scaffold Magmaris in Acute Coronary Syndrome: An Appraisal of Evidence and User Group Guidance.

Bioresorbable scaffolds provide transient vessel support without the long-term limitations of permanent metallic drug-eluting stents. The sirolimus-eluting resorbable magnesium scaffold Magmaris is the only CE-marked metallic bioresorbable scaffold and provides short-term lumen support before being completely bioresorbed. To date, clinical trial results have demonstrated low adverse event rates in patients with simple coronary lesions. Seven European centers with large experience in Magmaris implantation, combined efforts in an informal collaboration to evaluate and appraise clinical data currently available regarding the performance of Magmaris in patients presenting with acute coronary syndromes, and to supply user-advice on patient selection and optimal implantation practice.

Magmaris Resorbable Magnesium Scaffold Versus Conventional Drug-Eluting Stent in ST-Segment Elevation Myocardial Infarction: 1-Year Results of a Propensity-Score-Matching Comparison.

Magmaris® (Biotronik AG, Switzerland) is the first RMS and early experience has shown promising results in stable coronary artery disease. Acute coronary syndromes have been hypothesized as a potential target group for bioresorbable scaffolds, but the efficacy and safety of RMS has not been extensively studied in ST-segment elevation myocardial infarction (STEMI). BEST-MAG is a prospective multicenter trial designed to evaluate optical coherence tomography (OCT-)guided implantation of resorbable magnesium scaffold (RMS) in STEMI. Consecutive STEMI patients fulfilling inclusion/exclusion criteria were treated with RMS following a standardized OCT-based implantation technique including systematic pre- and post-dilatation, and baseline plus final OCT imaging. The primary endpoint was a device oriented composite endpoint (DOCE) including cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR) within 12 months. Clinical outcomes were compared after propensity score matching (PSM) to the results of the randomized controlled BIOSTEMI trial comparing biodegradable polymer sirolimus eluting (BP-SES) and durable polymer everolimus eluting stents (DP-EES) in STEMI. Between 15th February 2019 and 25th May 2020, 30 patients were included in 5 centers. Procedural success was achieved in all cases based on OCT control with final scaffold expansion of 82 ± 11%. At twelve-months, DOCE rate was 13.3% (n = 4), including 4 cases of TLR (13.3%) and one case of TV-MI (3.3%). No cardiac death occurred, and no scaffold thrombosis (ScT) was observed. Using PSM, DOCE rates in BP-SES and DP-EES groups were 10% and 6% respectively and TLR rates were 3.3% and 0.0%. In this study, OCT-guided RMS implantation in selected STEMI patients appeared feasible but was associated with numerically higher rates of TLR as compared with conventional drug-eluting stents, although the limited number of patients included in this analysis does not allow drawing statistically significant conclusions.

Guiding Myocardial Revascularization by Algorithmic Interpretation of FFR Pullback Curves: A Proof of Concept Study.

Background: Coronary artery disease distribution along the vessel is a main determinant of FFR improvement after PCI. Identifying focal from diffuse disease from visual inspections of coronary angiogram (CA) and FFR pullback (FFR-PB) are operator-dependent. Computer science may standardize interpretations of such curves. Methods: A virtual stenting algorithm (VSA) was developed to perform an automated FFR-PB curve analysis. A survey analysis of the evaluations of 39 vessels with intermediate disease on CA and a distal FFR <0.8, rated by 5 interventional cardiologists, was performed. Vessel disease distribution and PCI strategy were successively rated based on CA and distal FFR (CA); CA and FFR-PB curve (CA/FFR-PB); and CA and VSA (CA/VSA). Inter-rater reliability was assessed using Fleiss kappa and an agreement analysis of CA/VSA rating with both algorithmic and human evaluation (operator) was performed. We hypothesize that VSA would increase rater agreement in interpretation of epicardial disease distribution and subsequent evaluation of PCI eligibility. Results: Inter-rater reliability in vessel disease assessment by CA, CA/FFR-PB, and CA/VSA were respectively, 0.32 (95% CI: 0.17-0.47), 0.38 (95% CI: 0.23-0.53), and 0.4 (95% CI: 0.25-0.55). The raters' overall agreement in vessel disease distribution and PCI eligibility was higher with the VSA than with the operator (respectively, 67 vs. 42%, and 80 vs. 70%, both p < 0.05). Compared to CA/FFR-PB, CA/VSA induced more reclassification toward a focal disease (92 vs. 56.2%, p < 0.01) with a trend toward more reclassification as eligible for PCI (70.6 vs. 33%, p = 0.06). Change in PCI strategy did not differ between CA/FFR-PB and CA/VSA (23.6 vs. 28.5%, p = 0.38). Conclusions: VSA is a new program to facilitate and standardize the FFR pullback curves analysis. When expert reviewers integrate VSA data, their assessments are less variable which might help to standardize PCI eligibility and strategy evaluations. Clinical Trial Registration: https://www.clinicaltrials.gov/ct2/show/NCT03824600.

The evolution of the CTO-PCI landscape in Belgium and Luxembourg: a four-year appraisal.

BACKGROUND: To chart the evolution of the CTO-PCI landscape in Belgium and Luxembourg, the Belgian Working Group on Chronic Total Occlusions (BWGCTO) was established in 2016. METHODS: Between May 2016 and December 2019, patients undergoing a CTO-PCI treatment were prospectively and consecutively enrolled. Twenty-one centres in Belgium and one in Luxembourg participated. Individual operators had mixed levels of expertise in treating CTO lesions. Demographic, angiographic, procedural parameters and incidence of major adverse cardiac and cerebrovascular events (MACCE) were systematically registered. RESULTS: Over a four-year enrolment period, 1832 procedures were performed in 1733 patients achieving technical success in 1474 cases (80%), with an in-hospital MACCE rate of 2.3%. Fifty-nine (3%) cases were re-attempt procedures of which 41 (69%) were successful. High-volume centres treated more complex lesions (mean J-CTO score: 2.15 ± 1.21) as compared to intermediate (mean J-CTO score: 1.72 ± 1.23; p < 0.001) and low-volume centres (mean J-CTO score: 0.99 ± 1.21; p = 0.002). Despite this, success rates did not differ between centres (p = 0.461). Overall success rates did not differ over time (p = 0.810). High-volume centres progressively tackled more complex CTOs while keeping success rates stable. In all centres, the most applied strategy was antegrade wire escalation (83%). High-volume centres more often successfully applied antegrade dissection and re-entry and retrograde techniques in lesions with higher complexity. CONCLUSION: With variable experience levels, operators treated CTOs with high success and relatively few complications. Although AWE remains the most used technique, it is paramount for operators to be skilled in all contemporary techniques in order to be successful in more complex CTOs.

Cardiotoxicity of trastuzumab given for 12 months compared to shorter treatment periods: a systematic review and meta-analysis of six clinical trials.

BACKGROUND: Treatment de-escalation in early-stage, human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC) has been attempted in order to decrease costs and toxicities. One of the strategies pursued is decreasing trastuzumab treatment duration, with mixed results thus far. Trastuzumab-associated cardiotoxicity, however, may be more frequent with 12 months of trastuzumab compared with shorter treatment lengths. Therefore, we have conducted a meta-analysis to address this question. MATERIALS AND METHODS: A meta-analysis of trials testing 12 months of adjuvant trastuzumab versus shorter regimens, reporting cardiac outcomes in patients with HER2-positive BC was performed with the random effects model with inverse variance weighting. RESULTS: Clinical cardiac dysfunction associated with 12 months of trastuzumab versus shorter trastuzumab regimens, including 11 250 patients, showed a pooled OR (pOR) of 1.90 (95% CI 1.37 to 2.64; p value <0.001; I2=65.7%); in the subgroup comparison of 12 versus 6 months, the pOR was 1.57 (95% CI 1.30 to 1.90; p<0.001; I2=5.7%). pOR for low left ventricular ejection fraction was 1.45 (95% CI 1.19 to 1.75; p<0.001; I2=11.9%), 1.55 (95% CI 1.00 to 2.42; p=0.052; I2=0.0%) for congestive heart failure and 3.70 (95% CI 0.27 to 51.60; p=0.33; I2=78.8%) for premature trastuzumab discontinuation due to cardiotoxicity for 12 months versus shorter trastuzumab regimens. Funnel plot analyses indicated a low risk of publication bias. CONCLUSIONS: Compared to shorter treatment durations, there is sufficient evidence that 12 months of trastuzumab yields higher odds for the occurrence of relevant cardiac events. An individual patient-level data meta-analysis is needed in order to provide adequate data on risk factors for cardiotoxicity.

Magmaris resorbable magnesium scaffold for the treatment of coronary heart disease: overview of its safety and efficacy.

Introduction: Bioresorbable scaffold technology provides transient vessel support with drug-delivery capability without the long-term limitations of the permanent metallic drug-eluting stents (DES). The technology has the potential to overcome many of the safety concerns associated with metallic DES, such as hypersensitivity reactions, late stent thrombosis and progression of atherosclerosis within the stented segment (i.e. neoatherosclerosis). Areas covered: The sirolimus-eluting resorbable magnesium scaffold Magmaris is the only metallic CE-marked resorbable scaffold currently available. This magnesium scaffold is designed for providing a short-term lumen support (up to 3 months) before being completely bioresorbed, eliminating the permanent caging typical of the metallic DES. This review will focus on the device development and characteristics, currently available clinical efficacy and safety data, and potential future perspectives. Expert opinion: The first clinical studies testing this device in a small number of patients have shown promising results with good clinical and safety outcomes up to 3 years' clinical follow-up, supporting the use of Magmaris in simple coronary artery disease.

Comparison of Side-Branch Dilation Techniques After Resorbable Magnesium Scaffold Implantation: A Bench Study.

BACKGROUND: The resorbable magnesium scaffold (RMS) has demonstrated a good safety profile to treat de novo lesions. Nevertheless, bifurcation lesions involving a side branch (SB) >2.0 mm in diameter were excluded from these studies, and such lesions remain technically challenging due to concerns of scaffold deformation or fracture. We sought to evaluate different SB dilation strategies after provisional T-stenting strategy with RMS using silicon bifurcation phantoms. METHODS AND RESULTS: Three different strategies were compared: proximal optimization technique (POT)-side-rePOT (rePOT), kissing-balloon inflation (KBI), and mini kissing-balloon inflation (MKBI) strategies. Strut and connector fractures were evaluated by micro computed tomography and apposition by optical coherence tomography (OCT). Twelve Magmaris scaffolds (Biotronik) were successfully implanted (4 in each group). There was no difference in strut and connector fractures among the three techniques, as no fracture was visualized. OCT demonstrated that MKBI significantly decreased global malapposition following SB inflation as compared with rePOT or KBI strategies (95.3% vs 88.3% of perfectly apposed struts [P<.001] and 93.6% [P<.01], respectively, for MKBI vs rePOT and KBI). After step-by-step over-expansion of 6 RMS devices with 3.75 mm, 4.0 mm, and 4.5 mm NC balloons at 16 atm (ie, +1.5 mm from the initial 3.0 mm RMS), no strut or connector fracture could be visualized. CONCLUSION: Provisional single-stent technique with the Magmaris RMS on a bifurcation lesion is technically feasible with these three different strategies without scaffold fracture. MKBI strategy resulted in better apposition rates as compared with KBI or rePOT strategies. Nevertheless, Magmaris use in bifurcation lesions should not be advised before similar results are confirmed by in vivo studies.

Comparison of the biodegradable polymer everolimus-eluting stent with contemporary drug-eluting stents: A systematic review and meta-analysis.

AIMS: Despite similar efficacy and safety profile in pilot studies, bioresorbable polymer drug-eluting stents (BP-DES) could have potential benefit over latest generation durable polymer (DP)-DES by facilitating vessel healing, therefore reducing inflammation and neoatherosclerosis leading to enhanced clinical safety. Therefore, we sought to perform a meta-analysis of randomized clinical trials (RCTs) comparing the safety and efficacy of everolimus-eluting BP-DES (BP-EES) to second-generation DP-DES. METHODS AND RESULTS: We conducted a systematic review and meta-analysis to examine the safety and efficacy of BP-EES in patients treated for coronary artery disease. We searched PubMed, Scopus, and the Cochrane Library through February 2018 for RCTs that included outcome data on BP-EES. We identified four eligible studies, which included a total of 4631 patients. Three studies reported a follow-up of one year and one study of five years. The BP-EES group, included 2315 patients and the DP-DES group included 2316 patients (1143 treated with DP-EES and 1173 treated with zotarolimus eluting DP-DES). Patient's characteristics were comparable between the two groups except for higher prevalence of prior MI in the DP-DES group (25.7 vs 22.5%, respectively, p = 0.001). Procedural characteristics were comparable among groups except for slightly longer lesions in the BP-EES group compared to the DP-DES group (mean 15.1 vs 14.9 mm, p = 0.04). No significant differences were observed for cardiac mortality (p = 0.72), occurrence of MI (p = 0.64), any TLR (p = 0.93), ST (p = 0.85) or major adverse cardiac events (p = 0.43). CONCLUSION: Overall, based on the available data BP-EES had similar one-year outcomes to contemporary DP-DES. Whether these devices could enhance clinical safety remains to be evaluated at longer follow-up.

Clinical outcomes of bioresorbable vascular scaffold to treat all-comer patients. Are patients with acute coronary syndrome better candidates 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 ±â€¯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.