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ImportanceLong-term follow-up after transcatheter aortic valve replacement (TAVR) is of interest given that longitudinal data on mortality and durability of transcatheter heart valves are limited. The REPRISE III (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System—Randomized Clinical Evaluation) randomized clinical trial compared the mechanically expanded Lotus valve with the self-expanding CoreValve/EvolutR TAVR platforms.ObjectiveTo describe the final 5-year outcomes of the REPRISE III trial.Design, Setting, and ParticipantsThis prespecified secondary analysis assessed the final 5-year clinical, functional, and echocardiographic outcomes of 912 patients from the REPRISE III trial, which was conducted at 55 centers in North America, Europe, and Australia between September 22, 2014, and December 24, 2015. Patients had high risk for aortic stenosis or severe or symptomatic aortic stenosis. Data were analyzed from September 22, 2014, to May 21, 2021.InterventionLotus valve or CoreValve/EvolutR TAVR platforms.Main Outcomes and MeasuresValve Academic Research Consortium-2 end points, hemodynamic measures, functional status, and health status were examined through the 5-year follow-up.ResultsA total of 912 patients (mean [SD] age, 82.8 [7.3] years; 463 women [50.8%]) were randomized to either the Lotus valve group (n = 607) or CoreValve/EvolutR group (n = 305), with a baseline Society of Thoracic Surgeons risk score of 6.8%. Clinical follow-up data from the REPRISE III trial were available for 581 patients (95.7%) in the Lotus valve group and 285 patients (93.4%) in the CoreValve/EvolutR group. At 5 years, the cumulative event rate for all-cause mortality was 50.9% in the Lotus valve group vs 52.8% in the CoreValve/EvolutR group (P = .59). Disabling stroke was less frequent with the Lotus valve vs CoreValve/EvolutR (cumulative event rates, 8.3% vs 12.2%; P = .04), whereas the cumulative event rates for overall stroke were similar in both groups (14.1% vs 15.3%; P = .38). Insertion of a new permanent pacemaker (38.9% vs 27.3%; P P = .007) were more common in the Lotus valve group than in the CoreValve/EvolutR group. A smaller proportion of patients who received the Lotus valve experienced valve malpositioning (0% vs 2.6%; P P P 2 vs 1.42 [0.42] cm2; P = .10). After 5 years, the proportion of patients with moderate or greater paravalvular leak was not significantly higher with the CoreValve/EvolutR than with the Lotus valve (1.9% vs 0%; P = .31); however, the proportion of patients with mild paravalvular leak was higher in the CoreValve/EvolutR group compared with the Lotus valve group (23.1% vs 7.8%; P = .006). Long-term, similar improvements in New York Heart Association class and Kansas City Cardiomyopathy Questionnaire score were observed in both groups.Conclusions and RelevanceThe REPRISE III trial found that, at 5 years, the clinical outcomes of the Lotus valve were comparable to those of the CoreValve/EvolutR and that the Lotus valve was safe and effective.Trial RegistrationClinicalTrials.gov Identifier: NCT02202434

Background Autopsy studies suggest that implanting stents in lipid-rich plaque (LRP) may be associated with adverse outcomes. Objectives The purpose of this study was to evaluate the association between LRP detected by near-infrared spectroscopy (NIRS) and clinical outcomes in patients with coronary artery disease treated with contemporary drug-eluting stents. Methods In this prospective, multicenter registry, NIRS was performed in patients undergoing coronary angiography and possible percutaneous coronary intervention (PCI). Lipid core burden index (LCBI) was calculated as the fraction of pixels with the probability of LRP >0.6 within a region of interest. MaxLCBI4mm was defined as the maximum LCBI within any 4-mm-long segment. Major adverse cardiac events (MACE) included cardiac death, myocardial infarction, definite or probable stent thrombosis, or unplanned revascularization or rehospitalization for progressive angina or unstable angina. Events were subcategorized as culprit (treated) lesion–related, nonculprit (untreated) lesion–related, or indeterminate. Results Among 1,999 patients who were enrolled in the COLOR (Chemometric Observations of Lipid Core Plaques of Interest in Native Coronary Arteries Registry), PCI was performed in 1,621 patients and MACE occurred in 18.0% of patients, of which 8.3% were culprit lesion–related, 10.7% were nonculprit lesion–related, and 3.1% were indeterminate during 2-year follow-up. Complications from NIRS imaging occurred in 9 patients (0.45%), which resulted in 1 peri-procedural myocardial infarction and 1 emergent coronary bypass. Pre-PCI NIRS imaging was obtained in 1,189 patients, and the 2-year rate of culprit lesion–related MACE was not significantly associated with maxLCBI4mm (hazard ratio of maxLCBI4mm per 100: 1.06; 95% confidence interval: 0.96 to 1.17; p = 0.28) after adjusting clinical and procedural factors. Conclusions Following PCI with contemporary drug-eluting stents, stent implantation in NIRS-defined LRPs was not associated with increased periprocedural or late adverse outcomes compared with those without significant lipid.

Background: The Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support similar to those of metallic drug-eluting stents, followed by complete resorption in ≈3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year with BVS compared with cobalt chromium everolimus-eluting stents. Between 1 and 3 years and cumulative to 3 years, adverse event rates (particularly target vessel myocardial infarction and scaffold thrombosis) were increased after BVS. We sought to assess clinical outcomes after BVS through 5 years, including beyond the 3-year time point of complete scaffold resorption. Methods: Clinical outcomes from ABSORB III were analyzed by randomized device (intention to treat) cumulative to 5 years and between 3 and 5 years. Results: Rates of target lesion failure, target vessel myocardial infarction, and scaffold thrombosis were increased through the 5-year follow-up with BVS compared with everolimus-eluting stents. However, between 3 and 5 years, reductions in the relative hazards of the BVS compared with everolimus-eluting stents were observed, particularly for target lesion failure (hazard ratio, 0.83 [95% CI, 0.55–1.24] versus 1.35 [95% CI, 1.02–1.78]; P int =0.052) and scaffold thrombosis (hazard ratio, 0.26 [95% CI, 0.02–2.87] versus 3.23 [95% CI, 1.25–8.30]; P int =0.056) compared with the 0- to 3-year time period. Conclusions: In the ABSORB III trial, cumulative 5-year adverse event rates were increased after BVS compared with everolimus-eluting stents. However, the period of excess risk for BVS ended at 3 years, coincident with complete scaffold resorption. Clinical Trial Registration: URL: https://clinicaltrials.gov . Unique identifier: NCT01751906.

Background Treatment of mitral regurgitation (MR) in the setting of severe mitral annular calcification (MAC) is challenging due to the high risk for fatal atrioventricular groove disruption and significant paravalvular leak. Objectives The objective of this study was to evaluate the potential for transcatheter mitral valve replacement in patients with severe MAC using an anatomically designed mitral prosthesis. Methods Nine patients (77 ± 6 years of age; 5 men) were treated with the valve, using transapical delivery performed under general anesthesia and with guidance from transesophageal echocardiography and fluoroscopy. Results Device implantation was successful with relief of MR in all 9 patients. There were no procedural deaths. In 1 patient, left ventricular outflow tract obstruction occurred due to malrotation of the prosthesis, and successful alcohol septal ablation was performed. During a median follow-up of 12 months (range 1 to 28 months), there was 1 cardiac death, 1 noncardiac death, no other mortality, and no prosthetic dysfunction, and MR remained absent in all treated patients. Rehospitalization for heart failure occurred in 2 patients who did not die subsequently. Clinical improvement with mild or no symptoms occurred in all patients alive at the end of follow-up. Conclusions Transcatheter mitral valve replacement in severe mitral annular calcification with a dedicated prosthesis is feasible and can result in MR relief with symptom improvement. Further evaluation of this approach for these high-risk patients is warranted.

Patients presenting with hemodynamic instability attributable to left ventricular systolic dysfunction and concomitant severe mitral regurgitation (MR) are increasingly recognized and pose complex management challenges. Surgical therapy is typically precluded owing to prohibitive mortality. The role of percutaneous mechanical circulatory support in such cases is well established; however, such interventions may be neither sufficient to achieve optimal stability nor prove definitive. The advent of novel catheter-based mitral repair modalities now offers primary decisive therapeutic intervention. Three cases of cardiogenic shock with severe MR illustrate the salutary hemodynamic and clinical responses to percutaneous mechanical support and valve repair by mitral clip.

Background Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated. Objectives The purpose of this study was to examine outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the prosthesis. Methods The Global Feasibility Study enrolled symptomatic patients with either primary or secondary mitral regurgitation (MR) who were at high or prohibitive surgical risk. The present investigation examines the first 100 patients treated in this study. Clinical outcomes through last clinical follow-up were adjudicated independently. Results In the cohort (mean age 75.4 ± 8.1 years; 69% men), there was a high prevalence of severe heart failure symptoms (66%), left ventricular dysfunction (mean ejection fraction 46.4 ± 9.6%), and morbidities (Society of Thoracic Surgeons Predicted Risk of Mortality, 7.8 ± 5.7%). There were no intraprocedural deaths, 1 instance of major apical bleeding, and no acute conversion to surgery or need for cardiopulmonary bypass. Technical success was 96%. The 30-day rates of mortality and stroke were 6% and 2%, respectively. The 1-year survival free of all-cause mortality was 72.4% (95% confidence interval: 62.1% to 80.4%), with 84.6% of deaths due to cardiac causes. Among survivors at 1 year, 88.5% were New York Heart Association function class I/II, and improvements in 6-min walk distance (p Conclusions In this study of TMVR, which is the largest experience to date, the prosthesis was highly effective in relieving MR and improving symptoms, with an acceptable safety profile. Further study to optimize the impact on long-term survival is needed.

AIM We sought to determine the racial and ethnical disparities in the delivery of TAVR and to evaluate the in-hospital outcomes and utilization of TAVR stratified by patient ethnicity. METHOD Using a national inpatient sample database between 2011 and 2015, we identified all adult patients who had TAVR. Races were identified and white race was set as control. Multiple logistic regression analysis was performed for the primary outcome of in-hospital mortality. RESULTS Out of 58 174 patients who underwent TAVR, 50 809 (87.3%) were white, 2327 (4.0%) were black, 2311 (4.0%) were Hispanic, 640 (1.1%) Asian, 105 (0.2%) Native American and 1982 (3.4%) of other ethnicities. We found a statistically significant linear uptrend in the utilization of TAVR in patients of all races between the years 2011 and 2015. White, black, Hispanic and Native American patients had a downward linear trend for mortality during the studied years (P ≤ 0.005 for all). Black patients had lower in-hospital mortality [2.8 vs. 3.6%, odds ratio (OR) = 0.62; 95% confidence interval (CI) 0.44, 0.81 P

Background As transcatheter aortic valve replacement expands to younger and/or lower risk patients, the long‐term consequences of permanent pacemaker implantation are a concern. Pacemaker dependency and impact have not been methodically assessed in transcatheter aortic valve replacement trials. We report the incidence and predictors of pacemaker implantation and pacemaker dependency after transcatheter aortic valve replacement with the Lotus valve. Methods and Results A total of 912 patients with high/extreme surgical risk and symptomatic aortic stenosis were randomized 2:1 (Lotus:CoreValve) in REPRISE III (The Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System—Randomized Clinical Evaluation) trial. Systematic assessment of pacemaker dependency was pre‐specified in the trial design. Pacemaker implantation within 30 days was more frequent with Lotus than CoreValve. By multivariable analysis, predictors of pacemaker implantation included baseline right bundle branch block and depth of implantation; diabetes mellitus was also a predictor with Lotus. No association between new pacemaker implantation and clinical outcomes was found. Pacemaker dependency was dynamic (30 days: 43%; 1 year: 50%) and not consistent for individual patients over time. Predictors of pacemaker dependency at 30 days included baseline right bundle branch block, female sex, and depth of implantation. No differences in mortality or stroke were found between patients who were pacemaker dependent or not at 30 days. Rehospitalization was higher in patients who were not pacemaker dependent versus patients without a pacemaker or those who were dependent. Conclusions Pacemaker implantation was not associated with adverse clinical outcomes. Most patients with a new pacemaker at 30 days were not dependent at 1 year. Mortality and stroke were similar between patients with or without pacemaker dependency and patients without a pacemaker. Clinical Trial Registration URL : https://www.clinicaltrials.gov/ . Unique identifier NCT 02202434.

Significant progress has been made in the percutaneous coronary intervention technique from the days of balloon angioplasty to modern-day metallic drug-eluting stents (DES). Although metallic stents solve a temporary problem of acute recoil following balloon angioplasty, they leave behind a permanent problem implicated in very late events (in addition to neoatherosclerosis). BRS were developed as a potential solution to this permanent problem, but the promise of these devices has been tempered by clinical trials showing increased risk of safety outcomes, both early and late. This is not too dissimilar to the challenges seen with first-generation DES in which refinement of deployment technique, prolongation of dual antiplatelet therapy, and technical iteration mitigated excess risk of very late stent thrombosis, making DES the treatment of choice for coronary artery disease. This white paper discusses the factors potentially implicated in the excess risks, including the scaffold consideration and deployment technique, and outlines patient and lesion selection, implantation technique, and dual antiplatelet therapy considerations to potentially mitigate this excess risk with the first-generation thick strut Absorb scaffold (Abbott Vascular, Abbott Park, Illinois). It remains to be seen whether these considerations together with technical iterations will ultimately close the gap between scaffolds and metal stents for short-term events while at the same time preserving options for future revascularization once the scaffold bioresorbs.

Background The Absorb everolimus-eluting poly-L-lactic acid–based bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support functions similar to metallic drug-eluting stents (DES), followed by complete bioresorption in approximately 3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction [TVMI], or ischemia-driven target lesion revascularization) at 1 year in 2,008 patients with coronary artery disease randomized to BVS versus cobalt-chromium everolimus-eluting stents (EES). Objectives This study sought to assess clinical outcomes through 3 years following BVS implantation. Methods Clinical outcomes from the ABSORB III trial were analyzed by randomized treatment assignment cumulative through 3 years, and between 1 and 3 years. Results The primary composite endpoint of target lesion failure through 3 years occurred in 13.4% of BVS patients and 10.4% of EES patients (p = 0.06), and between 1 and 3 years in 7.0% versus 6.0% of patients, respectively (p = 0.39). TVMI through 3 years was increased with BVS (8.6% vs. 5.9%; p = 0.03), as was device thrombosis (2.3% vs. 0.7%; p = 0.01). In BVS-assigned patients, treatment of very small vessels (those with quantitatively determined reference vessel diameter Conclusions In the ABSORB III trial, 3-year adverse event rates were higher with BVS than EES, particularly TVMI and device thrombosis. Longer-term clinical follow-up is required to determine whether bioresorption of the polymeric scaffold will influence patient prognosis. (ABSORB III Randomized Controlled Trial [RCT] [ABSORB-III]; NCT01751906)

The permanent metal prosthesis common to bare metal stents (BMS) as well as both first- and second-generation drug-eluting stents (DES) following treatment of coronary artery disease represents a long-lasting substrate for late adverse coronary events including restenosis, thrombosis, and neoatherosclerosis. Following resorbtion, bioresorbable scaffolds (BRS) may eliminate this nidus and improve late outcomes through restoration of the vessel to more normal vascular structure and function. BRS represents a single platform which incorporates the mechanical features of metallic stents to provide safe and effective revascularization, suppression of restenosis and prevention of constrictive remodeling with long-term restoration of the treated vessel to a more natural state. The landscape of BRS is rapidly evolving with new materials which target various performance goals for the duration of vascular support and polymer resorption time. The Absorb bioresorbable vascular scaffold (Absorb BVS), recently approved by United States Food and Drug Administration, has extensive clinical evidence to date in support of its clinical efficacy and safety. Recently published data from well-executed randomized clinical trials (RCTs) as part of the ABSORB Clinical development program along with other investigator-initiated trials provide insights into the safety and performance of this device in patients with de novo coronary lesions as well in the setting of ST-segment elevation myocardial infarction (STEMI). This review provides a comprehensive, outcomes based understanding of the available evidence from RCTs that offer head-to-head comparisons of Absorb BVS with metallic everolimus-eluting stents (EES). © 2016 Wiley Periodicals, Inc.

BACKGROUND In patients with coronary artery disease who receive metallic drug-eluting coronary stents, adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall. Bioresorbable vascular scaffolds have been developed to attempt to improve longterm outcomes. METHODS In this large, multicenter, randomized trial, 2008 patients with stable or unstable angina were randomly assigned in a 2:1 ratio to receive an everolimus-eluting bioresorbable vascular (Absorb) scaffold (1322 patients) or an everolimus-eluting cobalt–chromium (Xience) stent (686 patients). The primary end point, which was tested for both noninferiority (margin, 4.5 percentage points for the risk difference) and superiority, was target-lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) at 1 year. RESULTS Target-lesion failure at 1 year occurred in 7.8% of patients in the Absorb group and in 6.1% of patients in the Xience group (difference, 1.7 percentage points; 95% confidence interval, −0.5 to 3.9; P = 0.007 for noninferiority and P = 0.16 for superiority). There was no significant difference between the Absorb group and the Xience group in rates of cardiac death (0.6% and 0.1%, respectively; P = 0.29), targetvessel myocardial infarction (6.0% and 4.6%, respectively; P = 0.18), or ischemiadriven target-lesion revascularization (3.0% and 2.5%, respectively; P = 0.50). Device thrombosis within 1 year occurred in 1.5% of patients in the Absorb group and in 0.7% of patients in the Xience group (P = 0.13). CONCLUSIONS In this large-scale, randomized trial, treatment of noncomplex obstructive coronary artery disease with an everolimus-eluting bioresorbable vascular scaffold, as compared with an everolimus-eluting cobalt–chromium stent, was within the prespecified margin for noninferiority with respect to target-lesion failure at 1 year. (Funded by Abbott Vascular; ABSORB III ClinicalTrials.gov number, NCT01751906.)

The advent of fully bioresorbable stent technology and specifically the ABSORB™, a bioresorbable vascular scaffold (BVS) stent, is heralded as breakthrough technology in the current era of percutaneous coronary interventions. This article reviews the current understanding of this technology along with the clinical evidence from trials and registries of ABSORB BVS that included patients with both simple as well as more complex "real-world" coronary lesions. In addition, considering the current limitations of this device-mostly associated with the mechanical properties of the polymeric scaffold structure-a review of guidelines on successful implantation of the ABSORB BVS is presented. Although expert feedback suggests extensive use of this device in routine clinical practice outside the United States despite a paucity of data on long-term safety in this setting, attention to procedural details and implantation technique is obligatory to achieve optimal clinical outcomes.

For many years, coronary artery bypass graft surgery has been the gold standard for revascularization of patients with left main disease; however, increasing evidence suggests that percutaneous coronary intervention with drug-eluting stents may be an acceptable alternative or even preferred in select cases. This review will present clinical evidence examining the outcomes of drug-eluting stents compared to coronary artery bypass graft surgery for unprotected left main coronary artery disease and discuss the anatomic factors, patient variables, and clinical strategies that may dictate choice of revascularization modality for patients with left main disease. If percutaneous coronary intervention is selected to treat unprotected left main disease, meticulous technique is essential to optimize outcomes, including use of procedural physiology and imaging guidance, optimal stent and adjunct pharmacology use, and expert management of the distal bifurcation. Finally, issues of equipoise and uncertainty are identified, representing areas for future investigation.

Drug eluting stents are considered the "gold standard" for the percutaneous treatment of coronary artery disease. Recent publications have suggested that a reasonable alternative, in well selected cases, may be the ABSORBTM bioresorbable vascular scaffold (BVS) stent. © 2016 Wiley Periodicals, Inc.

Drug eluting metallic stents have been the "gold standard" in the percutaneous management of coronary artery disease. Recent publications have suggested that the ABSORBTM bioresorbable vascular scaffold (BVS) may represent a reasonable alternative, in well selected cases.

The Absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California) is designed to reduce chronic adverse cardiovascular events that may occur from the permanent presence of a metallic stent and/or durable polymer. The systemic pharmacokinetic (PK) profile of BVS has not been

The Absorb everolimus-eluting poly-L-lactic acid-based bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support functions similar to metallic drug-eluting stents (DES), followed by complete bioresorption in approximately 3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction [TVMI], or ischemia-driven target lesion revascularization) at 1 year in 2,008 patients with coronary artery disease randomized to BVS versus cobalt-chromium everolimus-eluting stents (EES).This study sought to assess clinical outcomes through 3 years following BVS implantation.Clinical outcomes from the ABSORB III trial were analyzed by randomized treatment assignment cumulative through 3 years, and between 1 and 3 years.The primary composite endpoint of target lesion failure through 3 years occurred in 13.4% of BVS patients and 10.4% of EES patients (p = 0.06), and between 1 and 3 years in 7.0% versus 6.0% of patients, respectively (p = 0.39). TVMI through 3 years was increased with BVS (8.6% vs. 5.9%; p = 0.03), as was device thrombosis (2.3% vs. 0.7%; p = 0.01). In BVS-assigned patients, treatment of very small vessels (those with quantitatively determined reference vessel diameter 2.25 mm) was an independent predictor of 3-year TLF and scaffold thrombosis.In the ABSORB III trial, 3-year adverse event rates were higher with BVS than EES, particularly TVMI and device thrombosis. Longer-term clinical follow-up is required to determine whether bioresorption of the polymeric scaffold will influence patient prognosis. (ABSORB III Randomized Controlled Trial [RCT] [ABSORB-III]; NCT01751906).

Significant progress has been made in the percutaneous coronary intervention technique from the days of balloon angioplasty to modern-day metallic drug-eluting stents (DES). Although metallic stents solve a temporary problem of acute recoil following balloon angioplasty, they leave behind a permanent problem implicated in very late events (in addition to neoatherosclerosis). BRS were developed as a potential solution to this permanent problem, but the promise of these devices has been tempered by clinical trials showing increased risk of safety outcomes, both early and late. This is not too dissimilar to the challenges seen with first-generation DES in which refinement of deployment technique, prolongation of dual antiplatelet therapy, and technical iteration mitigated excess risk of very late stent thrombosis, making DES the treatment of choice for coronary artery disease. This white paper discusses the factors potentially implicated in the excess risks, including the scaffold consideration and deployment technique, and outlines patient and lesion selection, implantation technique, and dual antiplatelet therapy considerations to potentially mitigate this excess risk with the first-generation thick strut Absorb scaffold (Abbott Vascular, Abbott Park, Illinois). It remains to be seen whether these considerations together with technical iterations will ultimately close the gap between scaffolds and metal stents for short-term events while at the same time preserving options for future revascularization once the scaffold bioresorbs.

REPRISE III is the first large randomized comparison of 2 TAVR platforms: the mechanically-expanded Lotus valve (Boston Scientific, Marlborough, Massachusetts) and self-expanding CoreValve (CV) (Medtronic, Dublin, Ireland). In aortic stenosis patients with high/extreme surgical risk, Lotus was

Although current everolimus-eluting coronary stents have shown improved event-free survival within the first year following implantation compared with bare-metal stents or earlier generation drug-eluting stents, they remain associated with an ongoing risk for adverse outcomes (thrombosis, myocardial infarction, and restenosis) beyond 1 year at rates similar to those observed following bare-metal stent deployment. This ongoing very late hazard has been attributed to the permanent presence of the metal frame and/or polymer in these stents. The Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) has been developed to provide mechanical support and drug-delivery functions similar to metallic drug-eluting stents, followed by complete resorption with recovery of more normal vascular structure and function, thus avoiding the limitations associated with permanent metallic endovascular prostheses. Absorb BVS has shown safety and efficacy in the dedicated clinical trial development program of Abbott Vascular and in an array of investigator-sponsored studies involving a broad spectrum of clinical (patient) as well as coronary anatomic complexity. Longer-term evidence, largely limited to single-arm studies, appears to reflect durable safety and efficacy and suggests Absorb BVS to be an attractive therapeutic option. Interim evidence from a series of randomized-clinical trials (RCTs) comparing Absorb BVS with the Xience cobalt-chromium metallic everolimus-eluting stent has shown noninferiority of Absorb BVS with respect to target lesion failure (composite occurrence of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target lesion revascularization) beyond the first year, with no statistically significant differences in other safety/efficacy measures. However, concerns do exist in terms of increased rates of scaffold thrombosis, the risk for which may be mitigated by improved patient and lesion selection, procedural technique, and device iteration. We provide an overview of the evolution of percutaneous coronary intervention, in-vivo characterization of Absorb BVS resorption, and a summary with a critical evaluation of available evidence from RCTs, pooled analyses, and meta-analyses of RCTs for the safety and efficacy of Absorb BVS obtained primarily following the treatment of noncomplex coronary lesions in patients with stable ischemic heart disease and/or stabilized acute coronary syndromes.

Drug eluting metallic stents have been the "gold standard" in the percutaneous management of coronary artery disease. Recent publications have suggested that the ABSORBTM bioresorbable vascular scaffold (BVS) may represent a reasonable alternative, in well selected cases.

The Xience Side Branch Access (SBA) stent is an everolimus-eluting stent designed specifically for branching coronary geometry, providing wire access into the side branch (SB) regardless of the planned treatment strategy. The stent is delivered via a low-profile, dual-lumen, and single-tip catheter. A single inflation deploys the stent in the main branch (MB) and opens a portal into the SB. It is through this portal opening, allowing wire access into the SB, that this device differentiates itself from certain other dedicated bifurcation devices currently in various stages of development and testing. The Xience SBA stent was compared with a standard Multi-Link Vision® stent using a provisional T-stenting strategy in an ovine beating heart model. The Xience SBA stent tended to be deployed with less mean contrast usage (21.05 vs. 43.23 mL; P = 0.09), shorter fluoroscopy time (2.55 vs. 4.52 minute; P = 0.12), and lower rates of guidewire entanglement (16% vs. 100%) compared with the workhorse stent. As a result, the total procedure time with the Xience SBA stent was significantly shorter than that with the standard stent (5.46 vs. 8.65 minute; P = 0.01). The Xience SBA stent was also evaluated by four recently trained interventionalists who had no previous experience with the device. Using a perfused synthetic heart model, SB access time was reduced by 54%, average fluoroscopy time was reduced by 46%, and average contrast usage was lowered by 39% with the Xience SBA compared with the standard stent. Initial experience in the ovine model suggests that the Xience SBA stent is also amenable for use in distal left main coronary artery disease, regardless of whether it is deployed in the left ascending coronary artery or left circumflex artery and the portal opened in the opposing vessel. On the basis of these experimental results, the Xience SBA stent is an easy to use and versatile device for the purpose of SB access and potentially for the treatment of bifurcation coronary artery lesions.

Background— Percutaneous coronary intervention (PCI) is associated with periprocedural myocardial infarction (MI) in 3% to 15% of cases (depending on the definition used). In many cases, these MIs result from distal embolization of lipid-core plaque (LCP) constituents. Prospective identification of LCP with catheter-based near-infrared spectroscopy (NIRS) may predict an increased risk of periprocedural MI and facilitate development of preventive measures. Methods and Results— The present study analyzed the relationship between the presence of a large LCP (detected by NIRS) and periprocedural MI. Patients with stable preprocedural cardiac biomarkers undergoing stenting were identified from the COLOR Registry, an ongoing prospective observational study of patients undergoing NIRS before PCI. The extent of LCP in the treatment zone was calculated as the maximal lipid-core burden index (LCBI) measured by NIRS for each of the 4-mm longitudinal segments in the treatment zone. A periprocedural MI was defined as new cardiac biomarker elevation above 3× upper limit of normal. A total of 62 patients undergoing stenting met eligibility criteria. A large LCP (defined as a maxLCBI 4 mm ≥500) was present in 14 of 62 lesions (22.6%), and periprocedural MI was documented in 9 of 62 (14.5%) of cases. Periprocedural MI occurred in 7 of 14 patients (50%) with a maxLCBI 4 mm ≥500, compared with 2 of 48 patients (4.2%) patients with a lower maxLCBI 4 mm ( P =0.0002). Conclusions— NIRS provides rapid, automated detection of extensive LCPs that are associated with a high risk of periprocedural MI, presumably due to embolization of plaque contents during coronary intervention.

REPRISE III is the first large randomized comparison of 2 TAVR platforms: the mechanically-expanded Lotus valve (Boston Scientific, Marlborough, MA) and self-expanding CoreValve (Medtronic, Dublin, Ireland). In aortic stenosis patients with high/extreme surgical risk, Lotus was noninferior to

Coronary angiographic characteristics associated with lipid-rich plaque (LRP) detected by near-infrared spectroscopy (NIRS) are not well-defined. The COLOR registry was a prospective, multicenter, observational study of pts undergoing NIRS during PCI. Quantitative and qualitative coronary

Coronary bifurcation lesions are a common challenge for interventional cardiologists, for which there is no clear consensus on optimal treatment. The side branch (SB) ostium has become the focus of new treatment strategies because it is a common site of restenosis. In comparison, restenosis and reintervention rates in the main branch are acceptably low, reflecting improved techniques and greater use of drug-eluting stents. Many different companies are evaluating dedicated bifurcation devices that are designed to offer easy access to the SB, but that differ in concept and in the degree of coverage provided to the SB ostium. Some are bare metal stents, whereas several are drug-eluting iterations based on platforms used in conventional stents. The promise of these dedicated bifurcation devices is illustrated by early results from single-arm clinical studies.

Within labeled indications, drug-eluting stents (DES) are as safe as bare-metal stents (BMS). Data from key randomized, controlled trials comparing paclitaxel-eluting stents with BMS or sirolimus-eluting stents with BMS show no difference in risk of death/myocardial infarction or stent thrombosis using uniform definitions of stent thrombosis. However, these trials and other analyses indicate a difference in time distribution of stent thrombosis, with more cases of stent thrombosis occurring later (ie, after 1 year) in patients with DES--a problem to which the lack of adequate antiplatelet therapy appears to be a main contributor. A consistent finding from randomized, controlled trials of DES versus BMS is the significantly reduced need for reintervention associated with DES use. In the absence of any other differences in safety between DES and BMS, this reduced need for reintervention constitutes a significant advantage for DES in clinical practice.

The advent of fully bioresorbable stent technology and specifically the ABSORB™, a bioresorbable vascular scaffold (BVS) stent, is heralded as breakthrough technology in the current era of percutaneous coronary interventions. This article reviews the current understanding of this technology along with the clinical evidence from trials and registries of ABSORB BVS that included patients with both simple as well as more complex "real-world" coronary lesions. In addition, considering the current limitations of this device-mostly associated with the mechanical properties of the polymeric scaffold structure-a review of guidelines on successful implantation of the ABSORB BVS is presented. Although expert feedback suggests extensive use of this device in routine clinical practice outside the United States despite a paucity of data on long-term safety in this setting, attention to procedural details and implantation technique is obligatory to achieve optimal clinical outcomes.

Peri-procedural myocardial infarction (peri-MI) is the result of distal embolization of lipid-core plaque debris and/or thrombus during percutaneous coronary intervention (PCI) and is associated with short- and long-term adverse events. The COLOR Registry was a prospective, multicenter

An 83-year-old woman presented with recurrent heart failure 2 months after transcatheter aortic valve replacement (TAVR) with a Sapien 23-mm valve (Edwards Lifesciences, Irvine, California). Echocardiography demonstrated severe paravalvular leak (PVL). A 6-F multipurpose guide was advanced across

ObjectivesThis study sought to describe near-infrared spectroscopy (NIRS) findings of culprit lesions in ST-segment elevation myocardial infarction (STEMI).BackgroundAlthough autopsy studies demonstrate that most STEMI are caused by rupture of pre-existing lipid core plaque (LCP), it has not been possible to identify LCP in vivo. A novel intracoronary NIRS catheter has made it possible to detect LCP in patients.MethodsWe performed NIRS within the culprit vessels of 20 patients with acute STEMI and compared the STEMI culprit findings to findings in nonculprit segments of the artery and to findings in autopsy control segments. Culprit and control segments were analyzed for the maximum lipid core burden index in a 4-mm length of artery (maxLCBI4mm).ResultsMaxLCBI4mm was 5.8-fold higher in STEMI culprit segments than in 87 nonculprit segments of the STEMI culprit vessel (median [interquartile range (IQR)]: 523 [445 to 821] vs. 90 [6 to 265]; p 400 distinguished STEMI culprit segments from specimens free of large LCP by histology (sensitivity: 85%, specificity: 98%).ConclusionsThe present study has demonstrated in vivo that a maxLCBI4mm >400, as detected by NIRS, is a signature of plaques causing STEMI.

Unstable angina represents a heterogeneous spectrum of clinical entities between chronic stable angina and acute myocardial infarction. To facilitate prognostication of in-hospital outcome, we prospectively tested on a priori unstable angina classification scheme based on information available at the time of acute presentation. Prospective database enrollment at the time of emergency room presentation was performed and patients were classified into 1 of the following categories: class IA, acceleration of previous exertional angina without electrocardiographic (ECG) changes; class IB, acceleration of previous exertional angina with ECG changes; class II, new-onset exertional angina; class III, new-onset rest angina; class IV, protracted rest angina with ECG changes. The study consisted of 1,387 consecutive patients with unstable angina. Baseline demographics and aggregate in-hospital major cardiac event rates were recorded (myocardial infarction, refractory angina, and death). There was a significant increasing trend in cardiac events from class I to IV (p < 0.0001). Class IA patients had the lowest aggregate event rate at 2.7% (p = 0.0005). Paired chi-square tests of adjacent categories showed no differences in event rates for class IB and II (p = 0.3). A significantly higher rate of adverse events was seen for class III patients (20.1%, p < 0.0001). Class IV patients demonstrated the highest rate of in-hospital adverse events (42.8%, p < 0.0001). We conclude that this easily deduced, universally applicable categorization of unstable angina is highly prognostic of in-hospital adverse cardiac events and hence could have potential use for triage decisions regarding hospital admission and intensity of therapy.