Journal: JACC Cardiovasc Interv

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Abstract

Effect of CYP2C19 Genotype on Ischemic Outcomes During Oral P2Y Inhibitor Therapy: A Meta-Analysis.

Pereira NL, Rihal C, Lennon R, Marcus G, ... Murad MH, Farkouh ME
Objectives
The aim of this study was to examine the effect of CYP2C19 genotype on clinical outcomes in patients with coronary artery disease (CAD) who predominantly underwent percutaneous coronary intervention (PCI), comparing those treated with ticagrelor or prasugrel versus clopidogrel.
Background
The effect of CYP2C19 genotype on treatment outcomes with ticagrelor or prasugrel compared with clopidogrel is unclear.
Methods
Databases through February 19, 2020, were searched for studies reporting the effect of CYP2C19 genotype on ischemic outcomes during ticagrelor or prasugrel versus clopidogrel treatment. Study eligibility required outcomes reported for CYP2C19 genotype status and clopidogrel and alternative P2Y12 inhibitors in patients with CAD with at least 50% undergoing PCI. The primary analysis consisted of randomized controlled trials (RCTs). A secondary analysis was conducted by adding non-RCTs to the primary analysis. The primary outcome was a composite of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia. Meta-analysis was conducted to compare the 2 drug regimens and test interaction with CYP2C19 genotype.
Results
Of 1,335 studies identified, 7 RCTs were included (15,949 patients, mean age 62 years; 77% had PCI, 98% had acute coronary syndromes). Statistical heterogeneity was minimal, and risk for bias was low. Ticagrelor and prasugrel compared with clopidogrel resulted in a significant reduction in ischemic events (relative risk: 0.70; 95% confidence interval: 0.59 to 0.83) in CYP2C19 loss-of-function carriers but not in noncarriers (relative risk: 1.0; 95% confidence interval: 0.80 to 1.25). The test of interaction on the basis of CYP2C19 genotype status was statistically significant (p = 0.013), suggesting that CYP2C19 genotype modified the effect. An additional 4 observational studies were found, and adding them to the analysis provided the same conclusions (p value of the test of interaction <0.001).
Conclusions
The effect of ticagrelor or prasugrel compared with clopidogrel in reducing ischemic events in patients with CAD who predominantly undergo PCI is based primarily on the presence of CYP2C19 loss-of-function carrier status. These results support genetic testing prior to prescribing P2Y12 inhibitor therapy.

Copyright © 2021 American College of Cardiology Foundation. All rights reserved.

JACC Cardiovasc Interv: 11 Apr 2021; 14:739-750
Pereira NL, Rihal C, Lennon R, Marcus G, ... Murad MH, Farkouh ME
JACC Cardiovasc Interv: 11 Apr 2021; 14:739-750 | PMID: 33744207
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Abstract

The Role for Combined Antithrombotic Therapy With Platelet and Coagulation Inhibition After Lower Extremity Revascularization.

Weissler EH, Aboyans V, Bauersachs R, Brodmann M, ... Patel MR, Jones WS
Evidence for antithrombotic treatment following lower extremity revascularization (LER) for peripheral artery disease (PAD) is limited, leading to weak and conflicting guideline recommendations and heterogeneous practice patterns. This variability in post-LER antithrombotic treatment raises quality-of-care issues that have long been under-studied. This Viewpoint reviews the most updated guidelines, currently-available evidence, and contemporary data about practice patterns and practitioner opinions in this area. Particular attention is paid to distinctions between antiplatelet therapy, anticoagulant therapy, and combination therapy in light of the recent VOYAGER-PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) trial. The implications of VOYAGER-PAD pertaining to various subgroups of patients undergoing LER are explored. Overall, this Viewpoint argues for consideration of post-LER therapy targeted at both platelet function and the coagulation cascade, though further LER-specific analyses, including expected VOYAGER-PAD sub-analyses, are needed.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Apr 2021; 14:796-802
Weissler EH, Aboyans V, Bauersachs R, Brodmann M, ... Patel MR, Jones WS
JACC Cardiovasc Interv: 11 Apr 2021; 14:796-802 | PMID: 33826501
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Abstract

Stable Clinical Outcomes When a Stroke Thrombectomy Program Is Started in an Experienced Cardiology Cath Lab.

Sulženko J, Kožnar B, Peisker T, Vaško P, ... Štětkářová I, Widimský P
Objectives
This study analyzed the learning curve effect when a new stroke thrombectomy program was initiated in a cardiac cath lab in close cooperation with neurologists and radiologists.
Background
Mechanical thrombectomy has proven to be the best treatment option for ischemic stroke patients, but this method is not widely available.
Methods
An endovascular treatment program for acute ischemic strokes was established in the cardiac cath lab of a tertiary university hospital in 2012. The decision to perform catheter-based thrombectomy was made by a neurologist and was based on acute stroke clinical symptoms and computed tomography angiographic findings. Patients with a large vessel occlusion of either anterior or posterior circulation were enrolled. The primary endpoint was the functional neurological outcome (Modified Rankin Scale [mRS] score) of the patient at 3 months. A total of 333 patients were enrolled between October 2012 and December 2019.
Results
The clinical (mRS) outcomes did not vary significantly across years 2012 to 2019 (mRS 0 to 2 was achieved in 47.9% of patients). Symptomatic intracerebral hemorrhage occurred in 19 patients (5.7%). Embolization in a new vascular territory occurred in 6 patients (1.8%).
Conclusions
When a catheter-based thrombectomy program was initiated in an experienced cardiac cath lab in close cooperation between cardiologists, neurologists, and radiologists, outcomes were comparable to those of neuroradiology centers. The desired clinical results were achieved from the onset of the program, without any signs of a learning curve effect. These findings support the potential role of interventional cardiac cath labs in the treatment of acute stroke in regions where this therapy is not readily available due to the lack of neurointerventionalists.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Apr 2021; 14:785-792
Sulženko J, Kožnar B, Peisker T, Vaško P, ... Štětkářová I, Widimský P
JACC Cardiovasc Interv: 11 Apr 2021; 14:785-792 | PMID: 33826499
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Abstract

Evaluation of Dual Versus Triple Therapy by Landmark Analysis in the RE-DUAL PCI Trial.

Peterson BE, Bhatt DL, Gabriel Steg P, Oldgren J, ... Cannon CP, RE-DUAL PCI Steering Committee and Investigators
Objectives
The aim of this study was to explore the early versus late benefits and risks of dabigatran dual therapy versus warfarin triple therapy in the RE-DUAL PCI (Randomized Evaluation of Dual Antithrombotic Therapy With Dabigatran Versus Triple Therapy With Warfarin in Patients With Nonvalvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) trial.
Background
Patients with atrial fibrillation who undergo percutaneous coronary intervention are at increased risk for both bleeding and thrombotic events.
Methods
A total of 2,725 patients with atrial fibrillation underwent percutaneous coronary intervention and were randomized to receive dabigatran 110 mg, or dabigatran 150 mg plus a P2Y12 inhibitor (and no aspirin), or warfarin plus a P2Y12 inhibitor plus aspirin. Landmark analysis was performed at 30 and 90 days.
Results
There was a consistent and large reduction in major or clinically relevant nonmajor bleeding in patients randomized to dual therapy during the first 30 days (110 mg: hazard ratio [HR]: 0.45; 95% confidence interval [CI]: 0.31 to 0.66; p < 0.0001; 150 mg: HR: 0.46; 95% CI: 0.30 to 0.72; p = 0.0006) compared with warfarin triple therapy. There was early net clinical benefit in both dabigatran groups versus warfarin (110 mg: HR: 0.65; 95% CI: 0.47 to 0.88; p = 0.0062; 150 mg: HR: 0.54; 95% CI: 0.37 to 0.79; p = 0.0015), due to larger reductions in bleeding than increased thrombotic events for dabigatran 110 mg and bleeding reduction without increased thrombotic risk for dabigatran 150 mg dual therapy versus warfarin triple therapy. After the removal of aspirin in the warfarin group, bleeding remained lower with dabigatran 110 mg and was similar with dabigatran 150 mg versus warfarin.
Conclusions
In RE-DUAL PCI, in which patients in the dual-therapy arms were treated with aspirin for an average of only 1.6 days, there was early net clinical benefit with both doses of dabigatran dual therapy, without an increase in thrombotic events with dabigatran 150 mg. This could be helpful in the subset of patients with elevated risk for both bleeding and thrombotic events.

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Apr 2021; 14:768-780
Peterson BE, Bhatt DL, Gabriel Steg P, Oldgren J, ... Cannon CP, RE-DUAL PCI Steering Committee and Investigators
JACC Cardiovasc Interv: 11 Apr 2021; 14:768-780 | PMID: 33826497
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Abstract

Uninterrupted Oral Anticoagulant Therapy in Patients Undergoing Unplanned Percutaneous Coronary Intervention.

Venetsanos D, Skibniewski M, Janzon M, Lawesson SS, ... Omerovic E, Alfredsson J
Objectives
This study sought to compare interrupted and uninterrupted oral anticoagulant therapy (I-OAC vs. U-OAC) in patients on OAC undergoing percutaneous coronary intervention.
Background
There is a paucity of data regarding the optimal peri-procedural management of OAC-treated patients.
Methods
In the SWEDEHEART registry, all patients on OAC who were admitted acutely and underwent percutaneous coronary intervention or coronary angiography with a diagnostic procedure, from 2005 to 2017, were included. Outcomes were major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction, or stroke) and bleeds at 120 days. Propensity score was used to adjust for the nonrandomized treatment selection.
Results
The study included 6,485 patients: 3,322 in the I-OAC group and 3,163 in the U-OAC group. The cumulative incidence of MACCE was 8.2% (269 events) versus 8.2% (254 events) in the I-OAC and the U-OAC groups, respectively. The adjusted risk for MACCE did not differ between the groups (I-OAC vs. U-OAC hazard ratio: 0.89; 95% confidence interval: 0.71 to 1.12). Similarly, no difference was found in the risk for MACCE or bleeds (12.6% vs. 12.9%, adjusted hazard ratio: 0.87; 95% confidence interval: 0.70 to 1.07). The risk for major or minor in-hospital bleeds did not differ between the groups. However, U-OAC was associated with a significantly shorter duration of hospitalization: 4 (3 to 7) days versus 5 (3 to 8) days; p < 0.01.
Conclusions
I-OAC and U-OAC were associated with equivalent risk for MACCE and bleeding complications. An U-OAC strategy was associated with shorter length of hospitalization. These data support U-OAC as the preferable strategy in patients on OAC undergoing coronary intervention.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Apr 2021; 14:754-763
Venetsanos D, Skibniewski M, Janzon M, Lawesson SS, ... Omerovic E, Alfredsson J
JACC Cardiovasc Interv: 11 Apr 2021; 14:754-763 | PMID: 33826495
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Abstract

Antithrombotic Management of Elderly Patients With Coronary Artery Disease.

Capranzano P, Angiolillo DJ
Antithrombotic therapy represents the mainstay of treatment in patients with coronary artery disease (CAD), including elderly patients who are at increased risk for ischemic recurrences. However, the elderly population is also more vulnerable to bleeding complications. Numerous mechanisms, including abnormalities in the vasculature, thrombogenicity, comorbidities, and altered drug response, contribute to both increased thrombotic and bleeding risk. Age-related organ changes and drug-drug interactions secondary to polypharmacy lead to distinct pharmacokinetic and pharmacodynamic profiles of antithrombotic drugs. Overall these factors contribute to the risk-benefit profiles of antithrombotic therapies in elderly subjects and underscore the need for treatment regimens that can reduce bleeding while preserving efficacy. Given that the prevalence of CAD, as well as concomitant diseases with thromboembolic potential, such as atrial fibrillation, increases with age and that the elderly population is in continuous growth, understanding the safety and efficacy of different antithrombotic regimens is pivotal for patient-centered care. In the present overview the authors appraise the available data on the use of antithrombotic therapy in older patients with CAD to assist with the management of this high-risk population and define knowledge gaps that can set the basis for future research.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Apr 2021; 14:723-738
Capranzano P, Angiolillo DJ
JACC Cardiovasc Interv: 11 Apr 2021; 14:723-738 | PMID: 33826494
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Abstract

Age-Related Outcomes After Transcatheter Aortic Valve Replacement: Insights From the SwissTAVI Registry.

Attinger-Toller A, Ferrari E, Tueller D, Templin C, ... Goy JJ, Stortecky S
Objectives
The aim of this study was to investigate age-related outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) as assessed in a nationwide, prospective, multicenter cohort study.
Background
TAVR is the preferred treatment for elderly patients with severe aortic stenosis and is expanding into lower age groups.
Methods
Data from the SwissTAVI Registry were analyzed. Clinical outcomes were compared between patients 70 years of age or younger (n = 324), 70 to 79 years of age (n = 1,913), 80 to 89 years of age (n = 4,353), and older than 90 years of age (n = 507). Observed deaths were correlated with expected deaths in the general Swiss population using standardized mortality ratios.
Results
Between February 2011 and June 2018, 7,097 patients (mean age 82.0 ± 6.4 years, 49.6% women) underwent TAVR at 15 hospitals in Switzerland. Procedural characteristics were similar; however, older patients more often had discharge to the referring hospital or a rehabilitation facility after TAVR. Using adjusted analyses, a linear trend for mortality (30-day adjusted hazard ratio [HRadj]: 1.45; 95% confidence interval [CI]: 1.18 to 1.77; 1-year HRadj: 1.12; 95% CI: 1.01 to 1.24), cerebrovascular accidents (30-day HRadj: 1.35; 95% CI: 1.09 to 1.66; 1-year HRadj: 1.21; 95% CI: 1.02 to 1.45), and pacemaker implantation (30-day HRadj: 1.23; 95% CI: 1.12 to 1.34; 1-year HRadj: 1.19; 95% CI: 1.09 to 1.30) was observed with increasing age. Furthermore, standardized mortality ratios were 12.63 (95% CI: 9.06 to 17.58), 4.09 (95% CI: 3.56 to 4.74), 1.63 (95% CI: 1.50 to 1.78), and 0.93 (95% CI: 0.76 to 1.14) for TAVR patients in relation to the Swiss population <70, 70 to 79, 80 to 89 and ≥90 years of age, respectively.
Conclusions
Increasing age is associated with a linear trend for mortality, stroke, and pacemaker implantation during early and longer term follow-up after TAVR. Standardized mortality ratios were higher for TAVR patients younger than 90 years of age compared with expected rates of mortality in an age- and sex-matched Swiss population. (SWISS TAVI Registry; NCT01368250).

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 06 Apr 2021; epub ahead of print
Attinger-Toller A, Ferrari E, Tueller D, Templin C, ... Goy JJ, Stortecky S
JACC Cardiovasc Interv: 06 Apr 2021; epub ahead of print | PMID: 33865734
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Abstract

Prediction of Coronary Stent Underexpansion by Pre-Procedural Intravascular Ultrasound-Based Deep Learning.

Min HS, Ryu D, Kang SJ, Lee JG, ... Park SW, Park SJ
Objectives
The aim of this study was to develop pre-procedural intravascular ultrasound (IVUS)-based models for predicting the occurrence of stent underexpansion.
Background
Although post-stenting IVUS has been used to optimize percutaneous coronary intervention, there are no pre-procedural guidelines to estimate the degree of stent expansion and provide preemptive management before stent deployment.
Methods
A total of 618 coronary lesions in 618 patients undergoing percutaneous coronary intervention were randomized into training and test sets in a 5:1 ratio. Following the coregistration of pre- and post-stenting IVUS images, the pre-procedural images and clinical information (stent diameter, length, and inflation pressure; balloon diameter; and maximal balloon pressure) were used to develop a regression model using a convolutional neural network to predict post-stenting stent area. To separate the frames with from those without the occurrence of underexpansion (stent area <5.5 mm2), binary classification models (XGBoost) were developed.
Results
Overall, the frequency of stent underexpansion was 15% (5,209 of 34,736 frames). At the frame level, stent areas predicted by the pre-procedural IVUS-based regression model significantly correlated with those measured on post-stenting IVUS (r = 0.802). To predict stent underexpansion, maximal accuracy of 94% (area under the curve = 0.94) was achieved when the convolutional neural network- and mask image-derived features were used for the classification model. At the lesion level, there were significant correlations between predicted and measured minimal stent area (r = 0.832) and between predicted and measured total stent volume (r = 0.958).
Conclusions
Deep-learning algorithms accurately predicted incomplete stent expansion. A data-driven approach may assist clinicians in making treatment decisions to avoid stent underexpansion as a preventable cause of stent failure.

Copyright © 2021. Published by Elsevier Inc.

JACC Cardiovasc Interv: 06 Apr 2021; epub ahead of print
Min HS, Ryu D, Kang SJ, Lee JG, ... Park SW, Park SJ
JACC Cardiovasc Interv: 06 Apr 2021; epub ahead of print | PMID: 33865741
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Abstract

Characteristics and Outcomes of Patients With History of CABG Undergoing Cardiac Catheterization via the Radial Versus Femoral Approach.

Manly DA, Karrowni W, Rymer JA, Kaltenbach LA, ... Dakik H, Rao SV
Objectives
The aims of this study were to examine rates of radial artery access in post-coronary artery bypass grafting (CABG) patients undergoing diagnostic catherization and/or percutaneous coronary intervention (PCI), whether operators with higher procedural volumes and higher percentage radial use were more likely to perform diagnostic catherization and/or PCI via the radial approach in post-CABG patients, and clinical and procedural outcomes in post-CABG patients who undergo diagnostic catherization and/or PCI via the radial or femoral approach.
Background
There are limited data comparing outcomes of patients with prior CABG undergoing transradial or transfemoral diagnostic catheterization and/or PCI.
Methods
Using the National Cardiovascular Data Registry CathPCI Registry, all diagnostic catheterizations and PCIs performed in patients with prior CABG from July 1, 2009, to March 31, 2018 (n = 1,279,058 patients, 1,173 sites) were evaluated. Temporal trends in transradial access were examined, and mortality, bleeding, vascular complications, and procedural metrics were compared between transradial and transfemoral access.
Results
The rate of transradial access increased from 1.4% to 18.7% over the study period. Transradial access was associated with decreased mortality (adjusted odds ratio [OR]: 0.83; 95% confidence interval [CI]: 0.75 to 0.91), decreased bleeding (OR: 0.57; 95% CI: 0.51 to 0.63), decreased vascular complications (OR: 0.38; 95% CI: 0.30 to 0.47), increased PCI procedural success (OR: 1.11; 95% CI: 1.06 to 1.16; p < 0.0001), and significantly decreased contrast volume across all procedure types. Transradial access was associated with shorter fluoroscopy time for PCI-only procedures but longer fluoroscopy time for diagnostic procedures plus ad hoc PCI and diagnostic procedures only. Operators with a higher rate of transradial access in non-CABG patients were more likely to perform transradial access in patients with prior CABG.
Conclusions
The rate of transradial artery access in patients with prior CABG undergoing diagnostic catheterization and/or PCI has increased over the past decade in the United States, and it was more often performed by operators using a transradial approach in non-CABG patients. Compared with transfemoral access, transradial access was associated with improved clinical outcomes in patients with prior CABG.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 23 Mar 2021; epub ahead of print
Manly DA, Karrowni W, Rymer JA, Kaltenbach LA, ... Dakik H, Rao SV
JACC Cardiovasc Interv: 23 Mar 2021; epub ahead of print | PMID: 33812824
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Abstract

Sex-Related Clinical Characteristics and Outcomes of Patients Undergoing Transcatheter Edge-to-Edge Repair for Secondary Mitral Regurgitation.

Park SD, Orban M, Karam N, Lubos E, ... Hausleiter J, EuroSMR Investigators
Objectives
The authors sought to assess sex-based differences in characteristics and outcomes of patients undergoing transcatheter edge-to-edge mitral valve repair (TMVR) for secondary mitral regurgitation (SMR).
Background
Subgroup analysis from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial indicated potential sex-related differences in outcomes after TMVR. The impact of sex on results after TMVR in a real-world setting is unknown.
Methods
The authors assessed clinical outcomes and echocardiographic parameters in women and men undergoing TMVR for SMR between 2008 and 2018 who were included in the large, international, multicenter real-world EuroSMR registry (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation).
Results
A total of 1,233 patients, including 445 women (36%) and 788 men (64%), were analyzed. Although women were significantly older and had fewer comorbidities than men, TMVR was equally effective in women and men (mitral regurgitation [MR] grade ≤2+ at discharge: 93.2% vs. 94.6% for women vs. men; p = 0.35). All-cause mortality at 1 year (17.9% vs. 18.9%, adjusted hazard ratio: 0.806; p = 0.46) and at 2-year follow-up (26.5% vs. 26.4%, adjusted hazard ratio: 0.757; p = 0.26) were similar in women versus men after multivariate regression analysis. Durability of MR reduction, improvement in symptoms, quality of life, and functional capacity did also not differ during follow-up.
Conclusions
Results from the EuroSMR registry confirmed effective and similar MR reduction with TMVR in women and men. There were no sex-related differences in clinical outcomes up to 2 years of follow-up.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 23 Mar 2021; epub ahead of print
Park SD, Orban M, Karam N, Lubos E, ... Hausleiter J, EuroSMR Investigators
JACC Cardiovasc Interv: 23 Mar 2021; epub ahead of print | PMID: 33812815
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Abstract

Contemporary Revascularization Strategies and Outcomes Among Patients With Diabetes With Critical Limb Ischemia: Insights From the National Inpatient Sample.

Elbadawi A, Elgendy IY, Saad M, Elzeneini M, ... Drachman DE, Aronow HD
Objectives
The purpose of this study was to evaluate temporal trends in the frequency of revascularization and associated outcomes in patients with diabetes mellitus and critical limb ischemia (CLI).
Background
Little is known about outcomes following revascularization for CLI in patients with diabetes mellitus.
Methods
Temporal trends in hospitalization for CLI among patients with diabetes were determined using the 2002-2015 National Inpatient Sample database. Propensity score matching was used to compare patients who underwent revascularization with those who did not and, separately, to compare those who underwent endovascular versus surgical revascularization. The main study outcome was in-hospital mortality.
Results
The analysis included 1,222,324 hospitalizations. The number of hospitalizations for CLI among patients with diabetes increased over time (ptrend < 0.001). There was an increase in the use of lower extremity revascularization, paralleled by a decline in in-hospital mortality during the study period. In the matched cohort, patients who were revascularized had lower in-hospital mortality (odds ratio [OR]: 0.68; 95% confidence interval [CI]: 0.63 to 0.72) and major amputation (OR: 0.25; 95% CI: 0.24 to 0.27) compared with those who were treated medically. Compared with endovascular revascularization, those who underwent surgical revascularization had higher rates of in-hospital mortality (OR: 1.18; 95% CI: 1.04 to 1.35) but lower rates of major amputation (OR: 0.75; 95% CI: 0.70 to 0.81). Major bleeding, blood transfusion, post-operative infection, respiratory complications, discharges to nursing facility, and longer length of hospital stay were also more common among those who underwent surgery.
Conclusions
In this national analysis of patients with DM and CLI, we demonstrated an increase in hospitalization for CLI among patients with diabetes in the United States. Although in-hospital mortality decreased over time regardless of the treatment strategy used, this outcome occurred less frequently among those who underwent revascularization than not. Compared with surgical revascularization, endovascular revascularization was associated with lower in-hospital mortality but higher rates of major amputation.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 21 Mar 2021; 14:664-674
Elbadawi A, Elgendy IY, Saad M, Elzeneini M, ... Drachman DE, Aronow HD
JACC Cardiovasc Interv: 21 Mar 2021; 14:664-674 | PMID: 33640391
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Abstract

Biodegradable- Versus Durable-Polymer Drug-Eluting Stents for STEMI: Final 2-Year Outcomes of the BIOSTEMI Trial.

Pilgrim T, Muller O, Heg D, Roffi M, ... Windecker S, Iglesias JF
Objectives
The aim of this study was to investigate the safety and efficacy of biodegradable-polymer sirolimus-eluting stents (BP-SES) compared with durable-polymer everolimus-eluting stents (DP-EES) in patients with ST-segment elevation myocardial infarction (STEMI).
Background
Primary percutaneous coronary intervention (PCI) is an effective treatment for patients with STEMI, and long-term outcomes are determined by the safety and efficacy profile of the newest generation drug-eluting stents.
Methods
BIOSTEMI (A Comparison of an Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent for Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention) was an investigator-initiated, multicenter, assessor-blind, randomized superiority trial using Bayesian methods. Patients with STEMI undergoing primary PCI within 24 h of symptom onset were randomized in a 1:1 ratio to receive BP-SES (n = 649) or DP-EES (n = 651). The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial reinfarction, and clinically indicated target lesion revascularization (TLR) at 2 years.
Results
Between April 2016 and March 2018, 1,300 patients were included. Baseline characteristics were comparable between the 2 treatment groups. Follow-up through 2 years was complete in 1,221 patients (94%). At 2 years, TLF occurred in 33 patients (5.1%) treated with BP-SES and in 53 patients (8.1%) treated with DP-EES (rate ratio: 0.58; 95% Bayesian credible interval: 0.40 to 0.84; posterior probability of superiority = 0.998). The difference was driven by a lower incidence of clinically indicated TLR in patients treated with BP-SES compared with DP-EES (2.5% vs. 5.1%; rate ratio: 0.52; 95% Bayesian credible interval: 0.30 to 0.87; posterior probability of superiority = 0.993). There were no significant differences in rates of cardiac death, target vessel myocardial reinfarction, and definite stent thrombosis between the 2 treatment arms.
Conclusions
In patients with STEMI undergoing primary PCI, BP-SES were superior to DP-EES with respect to TLF at 2 years. The difference was driven by lower rates of ischemia-driven TLR. (A Comparison of an Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent for Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention [BIOSTEMI]; NCT02579031).

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 21 Mar 2021; 14:639-648
Pilgrim T, Muller O, Heg D, Roffi M, ... Windecker S, Iglesias JF
JACC Cardiovasc Interv: 21 Mar 2021; 14:639-648 | PMID: 33727005
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Abstract

2-Year Outcomes of the Eluvia Drug-Eluting Stent for the Treatment of Complex Femoropopliteal Lesions.

Stavroulakis K, Torsello G, Bosiers M, Argyriou A, Tsilimparis N, Bisdas T
Objectives
The aim of this study was to evaluate the 2-year performance of a polymer-based drug-eluting stent (DES) for the treatment of complex femoropopliteal lesions.
Background
Despite the promising early outcomes of the Eluvia DES, the long-term safety and efficacy of the device in a real-world scenario remain unclear.
Methods
Between March 2016 and December 2018, 130 patients (137 lesions) with symptomatic femoropopliteal disease were included in this study. The primary outcome measure of this analysis was primary patency. Secondary patency, freedom from target lesion revascularization, freedom from surgical conversion, and overall mortality and morbidity were additionally analyzed.
Results
The majority of patients presented with lifestyle-limiting claudication (n = 90 [69%]). The mean lesion length was 194 ± 108 mm, 74% of the lesions (n = 101) were chronic total occlusions, and 72% (n = 99) were calcified. Moderate to severe calcification (Peripheral Arterial Calcium Scoring Scale score 3 or 4) was observed in 48% of the treated vessels (n = 67). At 24 months, the Kaplan-Meier estimate of primary patency was 71%, whereas both the secondary patency rate and freedom from target lesion revascularization were 80%. Overall survival amounted to 85%. Freedom from major amputation was 98%, while freedom from surgical conversion was 89%. Degeneration of the vessel wall was observed in 27 lesions (20%).
Conclusions
In this study, use of the Eluvia polymer-based DES for the treatment of complex femoropopliteal disease showed promising 2-year results. Nonetheless, a relatively high rate of vessel wall degeneration was observed after DES deployment.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 21 Mar 2021; 14:692-701
Stavroulakis K, Torsello G, Bosiers M, Argyriou A, Tsilimparis N, Bisdas T
JACC Cardiovasc Interv: 21 Mar 2021; 14:692-701 | PMID: 33736776
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Abstract

Use of Atherectomy During Index Peripheral Vascular Interventions.

Hicks CW, Holscher CM, Wang P, Dun C, ... Hodgson KJ, Makary MA
Objectives
The aim of this study was to describe physician practice patterns and examine physician-level factors associated with the use of atherectomy during index revascularization for patients with femoropopliteal peripheral artery disease.
Background
There are minimal data to support the routine use of atherectomy over angioplasty and/or stenting for the endovascular treatment of peripheral artery disease.
Methods
Medicare fee-for-service claims (January 1 to December 31, 2019) were used to identify all beneficiaries undergoing elective first-time femoropopliteal peripheral vascular intervention (PVI) for claudication or chronic limb-threatening ischemia. Hierarchical logistic regression was used to evaluate patient- and physician-level characteristics associated with atherectomy.
Results
A total of 58,552 patients underwent index femoropopliteal PVI by 1,627 physicians. There was a wide distribution of physician practice patterns in the use of atherectomy, ranging from 0% to 100% (median 55.1%). Independent characteristics associated with atherectomy included treatment for claudication (vs. chronic limb-threatening ischemia; odds ratio [OR]: 1.51), patient diabetes (OR: 1.09), physician male sex (OR: 2.08), less time in practice (OR: 1.41 to 2.72), nonvascular surgery specialties (OR: 2.78 to 5.71), physicians with high volumes of femoropopliteal PVI (OR: 1.67 to 3.51), and physicians working primarily at ambulatory surgery centers or office-based laboratories (OR: 2.19 to 7.97) (p ≤ 0.03 for all). Overall, $266.8 million was reimbursed by Medicare for index femoropopliteal PVI in 2019. Of this, $240.6 million (90.2%) was reimbursed for atherectomy, which constituted 53.8% of cases.
Conclusions
There is a wide distribution of physician practice patterns for the use of atherectomy during index PVI. There is a critical need for professional guidelines outlining the appropriate use of atherectomy in order to prevent overutilization of this technology, particularly in high-reimbursement settings.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 21 Mar 2021; 14:678-688
Hicks CW, Holscher CM, Wang P, Dun C, ... Hodgson KJ, Makary MA
JACC Cardiovasc Interv: 21 Mar 2021; 14:678-688 | PMID: 33736774
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Abstract

Racial, Ethnic, and Sex Disparities in Patients With STEMI and Cardiogenic Shock.

Ya\'qoub L, Lemor A, Dabbagh M, O\'Neill W, ... Voeltz M, Basir MB
Objectives
The aim of this study was to evaluate the combined impact of race, ethnicity, and sex on in-hospital outcomes using data from the National Inpatient Sample.
Background
Cardiogenic shock (CS) is a major cause of mortality following ST-segment elevation myocardial infarction (STEMI). Early revascularization reduces mortality in such patients. Mechanical circulatory support (MCS) devices are increasingly used to hemodynamically support patients during revascularization. Little is known about racial, ethnic, and sex disparities in patients with STEMI and CS.
Methods
The National Inpatient Sample was queried from January 2006 to September 2015 for hospitalizations with STEMI and CS. The associations between sex, race, ethnicity, and outcomes were examined using complex-samples multivariate logistic or generalized linear model regressions.
Results
Of 159,339 patients with STEMI and CS, 57,839 (36.3%) were women. In-hospital mortality was higher for all women (range 40% to 45.4%) compared with men (range 30.4% to 34.7%). Women (adjusted odds ratio [aOR]: 1.11; 95% confidence interval [CI]: 1.06 to 1.16; p < 0.001) as well as Black (aOR: 1.18; 95% CI: 1.04 to 1.34; p = 0.011) and Hispanic (aOR: 1.19; 95% CI: 1.06 to 1.33; p = 0.003) men had higher odds of in-hospital mortality compared with White men, with Hispanic women having the highest odds of in-hospital mortality (aOR: 1.46; 95% CI: 1.26 to 1.70; p < 0.001). Women were older (age: 69.8 years vs. 63.2 years), had more comorbidities, and underwent fewer invasive cardiac procedures, including revascularization, right heart catheterization, and MCS.
Conclusions
There are significant racial, ethnic, and sex differences in procedural utilization and clinical outcomes in patients with STEMI and CS. Women are less likely to undergo invasive cardiac procedures, including revascularization and MCS. Women as well as Black and Hispanic patients have a higher likelihood of death compared with White men.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 21 Mar 2021; 14:653-660
Ya'qoub L, Lemor A, Dabbagh M, O'Neill W, ... Voeltz M, Basir MB
JACC Cardiovasc Interv: 21 Mar 2021; 14:653-660 | PMID: 33736772
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Abstract

Invasive Approaches in the Management of Cocaine-Associated Non-ST-Segment Elevation Myocardial Infarction.

Arora S, Jaswaney R, Jani C, Zuzek Z, ... Zidar D, Shishehbor MH
Objectives
The aim of this study was to determine the impact of invasive approaches and revascularization in patients with cocaine-associated non-ST-segment elevation myocardial infarction (NSTEMI).
Background
The role of invasive approaches in cocaine-associated NSTEMI is uncertain.
Methods
This retrospective cohort study identified 3,735 patients with NSTEMI and history of cocaine use from the Nationwide Readmissions Database from 2016 to 2017. Invasive approaches were defined as coronary angiography, percutaneous coronary intervention (PCI), and coronary artery bypass grafting (CABG). Revascularization was defined as PCI and CABG. The primary efficacy outcome was major adverse cardiac events (MACE), and the primary safety outcome was emergent revascularization. Nonadherence was identified using appropriate International Classification of Diseases-Tenth Revision codes. Two propensity-matched cohorts were generated (noninvasive vs. invasive and noninvasive vs. revascularization) through multivariate logistic regression.
Results
In the propensity score-matched cohorts, an invasive approach (hazard ratio [HR]: 0.72; 95% confidence interval [CI]: 0.56 to 0.92; p = 0.008) and revascularization (HR: 0.54; 95% CI: 0.40 to 0.73; p < 0.001) (compared with a noninvasive approach) were associated with a lower rate of MACE, without an increase in emergent revascularization. On stratification, PCI and CABG individually were associated with a lower rate of MACE. Emergent revascularization was increased with PCI (HR: 1.78; 95% CI: 1.12 to 2.81; p = 0.014) but not with CABG. Nonadherent patients after PCI and CABG did not have significant difference in rate of MACE. PCI in nonadherent patients was associated with an increase in emergent revascularization (HR: 4.45; 95% CI: 2.07 to 9.57; p < 0.001).
Conclusions
Invasive approaches and revascularization for cocaine-associated NSTEMI are associated with lower morbidity. A history of medical nonadherence was not associated with a difference in morbidity but was associated with an increased risk for emergent revascularization with PCI.

Copyright © 2021. Published by Elsevier Inc.

JACC Cardiovasc Interv: 21 Mar 2021; 14:623-636
Arora S, Jaswaney R, Jani C, Zuzek Z, ... Zidar D, Shishehbor MH
JACC Cardiovasc Interv: 21 Mar 2021; 14:623-636 | PMID: 33736770
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Abstract

Prognostic Links Between OCT-Delineated Coronary Morphologies and Coronary Functional Abnormalities in Patients With INOCA.

Nishimiya K, Suda A, Fukui K, Hao K, ... Yasuda S, Shimokawa H
Objectives
Whether there are prognostic links between coronary morphologies and coronary functional abnormalities was examined in ischemia and nonobstructive coronary artery disease (INOCA) patients.
Background
Although INOCA has attracted much attention, little is known about the prognostic impact of coronary morphologies in this disorder.
Methods
A total of 329 consecutive INOCA patients were enrolled and underwent spasm provocation testing combined with lactate sampling for diagnosis of epicardial and microvascular spasm (MVS). On the basis of the functional tests, the patients were classified into 4 groups: a control group without epicardial spasm or MVS (n = 32), MVS alone (n = 51), diffuse spasm in ≥2 coronary segments (n = 204), and focal spasm in 1 segment (n = 42). In this population, optical coherence tomography imaging of the left anterior descending coronary artery was performed for evaluation of adventitial vasa vasorum (AVV) and intraplaque neovessels (IPN). Index of microcirculatory resistance was also measured.
Results
MVS frequently coexisted with diffuse (70%) and focal spasm (68%) with a good correlation between AVV and index of microcirculatory resistance (R = 0.353; p = 0.022). For a median follow-up of 1,043 days, focal spasm showed the worst prognosis (log rank p = 0.005), for which IPN was a significant prognostic factor. By contrast, diffuse spasm showed the greatest AVV with an intermediate prognosis. The prognostic value of INOCA was significantly enhanced by adding AVV and IPN to the physiological indices (area under the curve = 0.88 vs. 0.76; p = 0.048).
Conclusions
These results provide the first evidence that there are important prognostic links between coronary morphologies (evaluated by optical coherence tomography) and coronary functional abnormalities in patients with INOCA, indicating the importance of both evaluations in this population.

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 21 Mar 2021; 14:606-618
Nishimiya K, Suda A, Fukui K, Hao K, ... Yasuda S, Shimokawa H
JACC Cardiovasc Interv: 21 Mar 2021; 14:606-618 | PMID: 33736768
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Abstract

Basics of Coronary Thermodilution.

Candreva A, Gallinoro E, van \'t Veer M, Sonck J, ... Pijls NHJ, De Bruyne B
Coronary microvascular dysfunction is a highly prevalent condition in both obstructive and nonobstructive coronary artery disease. Intracoronary thermodilution is a promising technique to investigate coronary microvascular (dys)function in vivo and to assess its most important metric: microvascular resistance. Here, the authors provide a practical review of bolus and continuous thermodilution for the measurement of coronary flow and microvascular resistance. The authors describe the basic principles of indicator-dilution theory and of coronary thermodilution and detail the practicalities of their application in the catheterization laboratory. Finally, the authors discuss contemporary clinical applications of coronary thermodilution-based microvascular assessment in humans and future perspectives.

Copyright © 2021. Published by Elsevier Inc.

JACC Cardiovasc Interv: 21 Mar 2021; 14:595-605
Candreva A, Gallinoro E, van 't Veer M, Sonck J, ... Pijls NHJ, De Bruyne B
JACC Cardiovasc Interv: 21 Mar 2021; 14:595-605 | PMID: 33736767
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Abstract

Online Quantitative Aortographic Assessment of Aortic Regurgitation After TAVR: Results of the OVAL Study.

Modolo R, van Mourik M, El Bouziani A, Kawashima H, ... de Winter R, Serruys PW
Objectives
The aim of this study was to investigate the online assessment feasibility of aortography using videodensitometry in the catheterization laboratory during transcatheter aortic valve replacement (TAVR).
Background
Quantitative assessment of regurgitation after TAVR through aortography using videodensitometry is simple, reproducible, and validated in vitro, in vivo, in clinical trials, and in \"real-world\" patients. However, thus far the assessment has been done offline.
Methods
This was a single center, prospective, proof-of-principle, feasibility study. One hundred consecutive patients with aortic stenosis and indications to undergo TAVR were enrolled. All final aortograms were analyzed immediately after acquisition in the catheterization laboratory and were also sent to an independent core laboratory for blinded offline assessment. The primary endpoint of the study was the feasibility of the online assessment of regurgitation (percentage of analyzable cases). The secondary endpoint was the reproducibility of results between the online assessment and the offline analysis by the core laboratory.
Results
Patients\' mean age was 81 ± 7 years, and 56% were men. The implanted valves were either SAPIEN 3 (97%) or SAPIEN 3 Ultra (3%). The primary endpoint of online feasibility of analysis was 92% (95% confidence interval [CI]: 86% to 97%) which was the same feasibility encountered by the core laboratory (92%; 95% CI: 86% to 97%). Reproducibility assessment showed a high correlation between online and core laboratory evaluations (R2 = 0.87, p < 0.001), with an intraclass correlation coefficient of 0.962 (95% CI: 0.942 to 0.975; p < 0.001).
Conclusions
This study showed high feasibility of online quantitative assessment of regurgitation and high agreement between the online examiner and core laboratory. These results may pave the way for the application of videodensitometry in the catheterization laboratory after TAVR. (Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab [OVAL]; NCT04047082).

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 07 Mar 2021; 14:531-538
Modolo R, van Mourik M, El Bouziani A, Kawashima H, ... de Winter R, Serruys PW
JACC Cardiovasc Interv: 07 Mar 2021; 14:531-538 | PMID: 33582086
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Abstract

Transfemoral Transcatheter Tricuspid Valve Replacement With the EVOQUE System: A Multicenter, Observational, First-in-Human Experience.

Fam NP, von Bardeleben RS, Hensey M, Kodali SK, ... Hahn RT, Webb JG
Objectives
The purpose of this observational first-in-human experience was to investigate the feasibility and safety of the EVOQUE tricuspid valve replacement system and its impact on short-term clinical outcomes.
Background
Transcatheter tricuspid intervention is a promising option for selected patients with severe tricuspid regurgitation (TR). Although transcatheter leaflet repair is an option for some, transcatheter tricuspid valve replacement (TTVR) may be applicable to a broader population.
Methods
Twenty-five patients with severe TR underwent EVOQUE TTVR in a compassionate-use experience. The primary outcome was technical success, with NYHA (NYHA) functional class, TR grade, and major adverse cardiac and cerebrovascular events assessed at 30-day follow-up.
Results
All patients (mean age 76 ± 3 years, 88% women) were at high surgical risk (mean Society of Thoracic Surgeons risk score 9.1 ± 2.3%), with 96% in NYHA functional class III or IV. TR etiology was predominantly functional, with mean tricuspid annular diameter of 44.8 ± 7.8 mm and mean tricuspid annular plane systolic excursion of 16 ± 2 mm. Technical success was 92%, with no intraprocedural mortality or conversion to surgery. At 30-day follow-up, mortality was 0%, 76% of patients were in NYHA functional class I or II, and TR grade was ≤2+ in 96%. Major bleeding occurred in 3 patients (12%), 2 patients (8%) required pacemaker implantation, and 1 patient (4%) required dialysis.
Conclusions
This first-in-human experience evaluating EVOQUE TTVR demonstrated high technical success, acceptable safety, and significant clinical improvement. Larger prospective studies are needed to confirm durability and safety and the impact on long-term clinical outcomes.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 07 Mar 2021; 14:501-511
Fam NP, von Bardeleben RS, Hensey M, Kodali SK, ... Hahn RT, Webb JG
JACC Cardiovasc Interv: 07 Mar 2021; 14:501-511 | PMID: 33582084
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Abstract

Long-Term Outcomes After Atrial Septal Defect Transcatheter Closure by Age and Against Population Controls.

Abrahamyan L, Dharma C, Alnasser S, Fang J, ... Osten M, Horlick EM
Objectives
The long-term outcomes after transcatheter closure of atrial septal defects (ASD) in adults are reported and compared between age groups and against population control patients.
Background
ASD is the second most common lesion in congenital heart disease. Comprehensive data on long-term outcomes after ASD closure are limited.
Methods
This retrospective cohort study enrolled adult patients with secundum ASD closure between 1998 and 2016. Information from a detailed clinical registry was linked to population-based administrative databases to capture outcomes. The population control cohort was matched using important prognostic characteristics.
Results
The cohort included 1,390 ASD patients of whom 32% were <40 years of age, 45% were 40 to 60 years of age, and 23% were >60 years of age at closure. The median follow-up was 10.6 years (interquartile range: 6.2 to 14.0 years). New-onset atrial fibrillation (AF) was the most frequent outcome overall (14.9%). The incidence of adverse cardiac and cerebrovascular events was higher in the >60 years of age group than in the younger groups. In adjusted analysis, patients >60 years of age continued exhibiting higher risk of all-cause (hazard ratio [HR]: 8.54; 95% confidence interval [CI]: 93.40 to 21.43) and cardiovascular (CV)-specific mortality compared with the <40 years of age group. The risk of new-onset AF (HR: 3.73; 95% CI: 2.79 to 4.98) and any AF hospitalization (HR: 1.55; 95% CI: 1.28 to 1.89) was higher in the ASD than in the control population, whereas there was no difference in all-cause and CV-specific mortality.
Conclusions
As expected, rates of adverse events post-ASD closure are higher in older age groups, but long-term mortality was comparable to that of a population control cohort. The high rates of AF necessitate future investigations.

Copyright © 2021. Published by Elsevier Inc.

JACC Cardiovasc Interv: 07 Mar 2021; 14:566-575
Abrahamyan L, Dharma C, Alnasser S, Fang J, ... Osten M, Horlick EM
JACC Cardiovasc Interv: 07 Mar 2021; 14:566-575 | PMID: 33663785
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Abstract

Association of Hospital Procedural Volume With Outcomes of Percutaneous Left Atrial Appendage Occlusion.

Nazir S, Ahuja KR, Kolte D, Isogai T, ... Gupta R, Kapadia SR
Objectives
The aim of this study was to examine the association between percutaneous left atrial appendage occlusion (LAAO) procedural volume and in-hospital outcomes.
Background
Several studies have demonstrated an inverse volume-outcome relationship for patients undergoing invasive cardiac procedures. Whether a similar association exists for percutaneous LAAO remains unknown.
Methods
Patients undergoing LAAO in 2017 were identified in the Nationwide Readmissions Database. Hospitals were categorized into 3 groups on the basis of tertiles of annual procedural volume: low (5 to 15 cases/year), medium (17 to 31 cases/year), and high (32 to 211 cases/year). Multivariate hierarchical logistic regression and restricted cubic spline analyses were performed to examine the association of hospital LAAO volume and outcomes. The primary outcome was in-hospital major adverse events (MAE), defined as a composite of mortality, stroke or transient ischemic attack, bleeding or transfusion, vascular complications, myocardial infarction, systemic embolization, and pericardial effusion or tamponade requiring pericardiocentesis or surgery.
Results
This study included 5,949 LAAO procedures performed across 196 hospitals with a median annual procedural volume of 41 (interquartile range: 25 to 67). Low-volume hospitals had higher rates of in-hospital MAE (9.5% vs. 5.6%; p < 0.001), stroke or transient ischemic attack (2.1% vs. 1.3%; p = 0.049), and bleeding or transfusion (6.1% vs. 3.5%; p = 0.002) compared with high-volume hospitals. No differences were noted for other components of MAE and index length of stay. On multivariate analysis, higher procedural volume was associated with lower rates of in-hospital MAE, with an adjusted odds ratio for medium versus low volume of 0.69 (95% confidence interval: 0.46 to 1.04; p = 0.08) and for high versus low volume of 0.55 (95% confidence interval: 0.37 to 0.82; p = 0.003).
Conclusions
Higher hospital procedural volume is associated with better outcomes for LAAO procedures. Further studies are needed to determine if this relationship persists for long-term outcomes.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 07 Mar 2021; 14:554-561
Nazir S, Ahuja KR, Kolte D, Isogai T, ... Gupta R, Kapadia SR
JACC Cardiovasc Interv: 07 Mar 2021; 14:554-561 | PMID: 33663783
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Abstract

Tip-to-Base LAMPOON for Transcatheter Mitral Valve Replacement With a Protected Mitral Annulus.

Lisko JC, Babaliaros VC, Khan JM, Kamioka N, ... Lederman RJ, Greenbaum AB
Objectives
The purpose of this study was to evaluate tip-to-base intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) in patients undergoing transcatheter mitral valve replacement (TMVR) in annuloplasty rings or surgical mitral valves.
Background
LAMPOON is an effective adjunct to TMVR that prevents left ventricular outflow tract obstruction (LVOTO). Laceration is typically performed from the base to the tip of the anterior mitral leaflet. A modified laceration technique from leaflet tip to base may be effective in patients with a prosthesis that protects the aortomitral curtain.
Methods
This is a multicenter, 21-patient, consecutive retrospective observational cohort. Patients underwent tip-to-base LAMPOON to prevent LVOTO and leaflet overhang, or therapeutically to lacerate a long anterior mitral leaflet risking or causing LVOTO. Outcomes were compared with findings from patients in the LAMPOON investigational device exemption trial with a prior mitral annuloplasty.
Results
Twenty-one patients with a annuloplasty or valve prosthesis-protected mitral annulus underwent tip-to-base LAMPOON (19 preventive, 2 rescue). Leaflet laceration was successful in all and successfully prevented or treated LVOTO in all patients. No patients had significant LVOTO upon discharge. There were 2 cases of unintentional aortic valve injury (1 patient underwent emergency transcatheter aortic valve replacement and 1 patient underwent urgent surgical aortic valve replacement). In both cases, the patients had a supra-annular ring annuloplasty, and the retrograde aortic guiding catheter failed to insulate the guidewire lacerating surface from the aortic root. All patients survived to 30 days. Compared with classic retrograde LAMPOON, there was a trend toward shorter procedure time.
Conclusions
Tip-to-base laceration is a simple, effective, and safe LAMPOON variant applicable to patients with an appropriately positioned mitral annular ring or bioprosthetic valve. Operators should take care to insulate the lacerating surface from adjacent structures.

Copyright © 2021. Published by Elsevier Inc.

JACC Cardiovasc Interv: 07 Mar 2021; 14:541-550
Lisko JC, Babaliaros VC, Khan JM, Kamioka N, ... Lederman RJ, Greenbaum AB
JACC Cardiovasc Interv: 07 Mar 2021; 14:541-550 | PMID: 33663781
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Abstract

Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement: REFLECT II.

Nazif TM, Moses J, Sharma R, Dhoble A, ... Lansky AJ, REFLECT II Trial Investigators
Objectives
The REFLECT II (Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Implantation) trial was designed to investigate the safety and efficacy of the TriGUARD 3 (TG3) cerebral embolic protection in patients undergoing transcatheter aortic valve replacement.
Background
Cerebral embolization occurs frequently following transcatheter aortic valve replacement and procedure-related ischemic stroke occurs in 2% to 6% of patients at 30 days. Whether cerebral protection with TriGuard 3 is safe and effective in reducing procedure-related cerebral injury is not known.
Methods
This prospective, multicenter, single-blind, 2:1 randomized (TG3 vs. no TG3) study was designed to enroll up to 345 patients. The primary 30-day safety endpoint (Valve Academic Research Consortium-2 defined) was compared with a performance goal (PG). The primary hierarchical composite efficacy endpoint (including death or stroke at 30 days, National Institutes of Health Stroke Scale score worsening in hospital, and cerebral ischemic lesions on diffusion-weighted magnetic resonance imaging at 2 to 5 days) was compared using the Finkelstein-Schoenfeld method.
Results
REFLECT II enrolled 220 of the planned 345 patients (63.8%), including 41 roll-in and 179 randomized patients (121 TG3 and 58 control subjects) at 18 US sites. The sponsor closed the study early after the U.S. Food and Drug Administration recommended enrollment suspension for unblinded safety data review. The trial met its primary safety endpoint compared with the PG (15.9% vs. 34.4% (p < 0.0001). The primary hierarchal efficacy endpoint at 30 days was not met (mean scores [higher is better]: -8.58 TG3 vs. 8.08 control; p = 0.857). A post hoc diffusion-weighted magnetic resonance imaging analysis of per-patient total lesion volume above incremental thresholds showed numeric reductions in total lesion volume >500 mm3 (-9.7%) and >1,000 mm3 (-44.5%) in the TG3 group, which were more pronounced among patients with full TG3 coverage: -51.1% (>500 mm3) and -82.9% (>1,000 mm3).
Conclusions
The REFLECT II trial demonstrated that the TG3 was safe compared with a historical PG but did not meet its pre-specified primary superiority efficacy endpoint.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 07 Mar 2021; 14:515-527
Nazif TM, Moses J, Sharma R, Dhoble A, ... Lansky AJ, REFLECT II Trial Investigators
JACC Cardiovasc Interv: 07 Mar 2021; 14:515-527 | PMID: 33663779
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Abstract

Transcatheter Mitral Valve Replacement: An Update on Current Techniques, Technologies, and Future Directions.

Hensey M, Brown RA, Lal S, Sathananthan J, ... Boone R, Webb JG
Growing clinical data support the use of transcatheter therapies for significant mitral valve disease. Currently, edge-to-edge repair is the transcatheter treatment of choice, but many anatomies are not suitable. Transcatheter mitral valve replacement offers several potential advantages over transcatheter repair, most notably a greater and more sustained reduction in mitral regurgitation post-implantation, but also potential disadvantages. To enable the successful treatment of mitral valve disease in a wide range of patients and anatomies, we require an armory of transcatheter devices, including transcatheter mitral valve replacement systems.

Crown Copyright © 2021. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 07 Mar 2021; 14:489-500
Hensey M, Brown RA, Lal S, Sathananthan J, ... Boone R, Webb JG
JACC Cardiovasc Interv: 07 Mar 2021; 14:489-500 | PMID: 33663778
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Abstract

Stent Thrombosis Risk Over Time on the Basis of Clinical Presentation and Platelet Reactivity: Analysis From ADAPT-DES.

Chau KH, Kirtane AJ, Easterwood RM, Redfors B, ... Mehran R, Stone GW
Objectives
The aim of this study was to determine the risk period for increased stent thrombosis (ST) after percutaneous coronary intervention (PCI) in patients with acute coronary syndromes (ACS) and whether this increased risk is related to high platelet reactivity (HPR).
Background
ST risk after PCI is higher among patients with ACS than those with stable ischemic heart disease. When ST risk is highest in patients with ACS and how that is affected by HPR is unknown.
Methods
Using the ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) registry, ST rates during 2-year follow-up post-PCI with drug-eluting stents were compared among patients presenting with ACS (myocardial infarction [MI] or unstable angina) or stable ischemic heart disease (non-ACS). Landmark analyses were done at 30 days and 1 year post-PCI. Platelet reactivity on aspirin and clopidogrel post-PCI was assessed using VerifyNow assays.
Results
Of 8,582 patients, 2,063 presented with MI, 2,370 with unstable angina, and 4,149 with non-ACS. Incidence rates of HPR were 48.0%, 43.3%, and 39.8%, respectively (p < 0.001). Within the first 30 days post-PCI, patients presenting with MI had increased ST risk compared with patients with non-ACS (hazard ratio [HR]: 4.52; 95% confidence interval [CI]: 2.01 to 10.14; p < 0.001). After 30 days, relative ST risks were progressively lower and no longer significant between groups (31 days to 1 year post-PCI: HR: 1.97; 95% CI: 0.80 to 4.85; >1 year post-PCI: HR: 0.89; 95% CI: 0.27 to 2.92). The elevated ST risk in patients with MI within 30 days was largely confined to those with HPR on clopidogrel (HR: 5.77; 95% CI: 2.13 to 15.63; p < 0.001).
Conclusions
Among patients undergoing PCI, rates of ST during 2-year follow-up were highest in those with MI and lowest in those with non-ACS. Increased ST risk in patients with MI was greatest in the first 30 days post-PCI and was observed predominantly among those with increased HPR on clopidogrel. These findings emphasize the importance of adequate P2Y12 inhibition after MI, especially within the first 30 days after stent implantation.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 21 Feb 2021; 14:417-427
Chau KH, Kirtane AJ, Easterwood RM, Redfors B, ... Mehran R, Stone GW
JACC Cardiovasc Interv: 21 Feb 2021; 14:417-427 | PMID: 33516690
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Abstract

Potential of an Approach Based on the Identification and Treatment of Vulnerable Coronary Plaques.

Prati F, Arbustini E, Alfonso F
In this viewpoint paper, the authors are tackling criticism to the limits of invasive imaging modalities for identification and treatment of vulnerable plaques. They believe in the clinical usefulness of invasive imaging modalities for identification of vulnerable plaques, and are suggesting an explanation for the suboptimal results of past studies, that failed to demonstrate a correlation between interventional treatment of vulnerable plaques, and reduction of hard clinical endpoints. Vulnerability studies have been based, so far, on the detection and measurement of plaques lipid content, because of its ease. However, the search for lipid \"lakes\" as a single common causal feature of acute coronary syndromes does not seem sufficient to identify patients at risk of adverse events. New imaging studies provided the rationale for improving clinical outcomes, adopting a more comprehensive assessment of target plaque morphology. There is little rationale in pursuing a functional assessment of coronary lesions to predict myocardial infarction. Recent studies are further confirming this hypothesis, suggesting that the clinical benefit of the fractional flow reserve-guided strategy is simply due to a significant reduction in the rate of repeated revascularizations, with no significant differences in the incidence of hard endpoints. There is a need to develop new randomized studies, requiring a feasible number of patients, to test the superiority of an approach based on vulnerable plaque sealing and treatment.

Copyright © 2021. Published by Elsevier Inc.

JACC Cardiovasc Interv: 21 Feb 2021; 14:468-473
Prati F, Arbustini E, Alfonso F
JACC Cardiovasc Interv: 21 Feb 2021; 14:468-473 | PMID: 33602444
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Abstract

Stenting \"Vulnerable\" But Fractional Flow Reserve-Negative Lesions: Potential Statistical Limitations of Ongoing and Future Trials.

Zimmermann FM, Pijls NHJ, Gould KL, Johnson NP
Can imaging provide sufficient risk stratification to warrant revascularization of a stable plaque with negative fractional flow reserve (FFR)? Prophylactic stenting could at best be applied selectively since the composite group of FFR-negative lesions has a death or myocardial infarction rate of approximately 1%/year or less but modern stents have a rate of 2% to 3.5%/year. Because vulnerable features exist in a minority of lesions, at least 9,000 patients must be screened in order to enroll a cohort with sufficient risk. While several ongoing randomized trials are testing the concept of plaque sealing in FFR-negative lesions, preventive stenting depends on such a small effect that sample sizes to validate or refute its benefit become prohibitive. Since FFR provides a quantitative, straightforward, and reproducible metric of plaque vulnerability and burden without the need for or expense of additional catheter devices, intracoronary imaging cannot meaningfully guide prophylactic stenting when faced with a negative FFR.

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 21 Feb 2021; 14:461-467
Zimmermann FM, Pijls NHJ, Gould KL, Johnson NP
JACC Cardiovasc Interv: 21 Feb 2021; 14:461-467 | PMID: 33602443
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Abstract

Ticagrelor Monotherapy Versus Dual-Antiplatelet Therapy After PCI: An Individual Patient-Level Meta-Analysis.

Valgimigli M, Mehran R, Franzone A, da Costa BR, ... Jüni P, SIDNEY Collaboration
Objectives
The aim of this study was to compare ticagrelor monotherapy with dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stents.
Background
The role of abbreviated DAPT followed by an oral P2Y12 inhibitor after PCI remains uncertain.
Methods
Two randomized trials, including 14,628 patients undergoing PCI, comparing ticagrelor monotherapy with standard DAPT on centrally adjudicated endpoints were identified, and individual patient data were analyzed using 1-step fixed-effect models. The protocol was registered in PROSPERO (CRD42019143120). The primary outcomes were the composite of Bleeding Academic Research Consortium type 3 or 5 bleeding tested for superiority and, if met, the composite of all-cause death, myocardial infarction, or stroke at 1 year, tested for noninferiority against a margin of 1.25 on a hazard ratio (HR) scale.
Results
Bleeding Academic Research Consortium type 3 or 5 bleeding occurred in fewer patients with ticagrelor than DAPT (0.9% vs. 1.7%, respectively; HR: 0.56; 95% confidence interval [CI]: 0.41 to 0.75; p < 0.001). The composite of all-cause death, myocardial infarction, or stroke occurred in 231 patients (3.2%) with ticagrelor and in 254 patients (3.5%) with DAPT (HR: 0.92; 95% CI: 0.76 to 1.10; p < 0.001 for noninferiority). Ticagrelor was associated with lower risk for all-cause (HR: 0.71; 95% CI: 0.52 to 0.96; p = 0.027) and cardiovascular (HR: 0.68; 95% CI: 0.47 to 0.99; p = 0.044) mortality. Rates of myocardial infarction (2.01% vs. 2.05%; p = 0.88), stent thrombosis (0.29% vs. 0.38%; p = 0.32), and stroke (0.47% vs. 0.36%; p = 0.30) were similar.
Conclusions
Ticagrelor monotherapy was associated with a lower risk for major bleeding compared with standard DAPT, without a concomitant increase in ischemic events.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 21 Feb 2021; 14:444-456
Valgimigli M, Mehran R, Franzone A, da Costa BR, ... Jüni P, SIDNEY Collaboration
JACC Cardiovasc Interv: 21 Feb 2021; 14:444-456 | PMID: 33602441
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Abstract

Ticagrelor Monotherapy Versus Ticagrelor With Aspirin in Patients With ST-Segment Elevation Myocardial Infarction.

Lee SJ, Cho JY, Kim BK, Yun KH, ... Jang Y, TICO Investigators
Objectives
The aim of this study was to assess whether the effects of ticagrelor monotherapy after 3-month dual-antiplatelet therapy (DAPT) are consistent among patients presenting with ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction, and unstable angina treated with drug-eluting stents.
Background
Ticagrelor monotherapy after short-term DAPT has not been investigated in patients with STEMI.
Methods
This was a pre-specified, stratified, subgroup analysis of the STEMI cohort from the TICO (Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome) trial, which constituted 36% of the total population. The primary outcome was a composite of major bleeding and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction, stent thrombosis, stroke, or target vessel revascularization). The secondary outcomes were major bleeding and MACCE.
Results
The incidence of the primary outcome was 4.4% in patients with STEMI (n = 1,103), 6.0% in those with non-ST-segment elevation myocardial infarction (n = 1,027), and 4.1% in those with unstable angina (n = 926), without statistical significance (p = 0.09). Compared with ticagrelor-based 12-month DAPT, ticagrelor monotherapy after 3-month DAPT showed consistent effects on the primary outcome across clinical presentations (p for interaction [pint] = 0.64). Furthermore, the effect of ticagrelor monotherapy on the reduction of major bleeding was consistent across clinical presentations (pint = 0.36). The effect of ticagrelor monotherapy on MACCE was also consistent in patients with STEMI, without evidence of a higher risk for MACCE (pint = 0.14).
Conclusions
This pre-specified subgroup analysis revealed no heterogeneity in the effects of ticagrelor monotherapy after 3-month DAPT, compared with 12-month DAPT, for the primary outcome, major bleeding, and MACCE across clinical presentations including STEMI, though larger studies are needed to demonstrate these findings with adequate power. (Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome [TICO Study]; NCT02494895).

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 21 Feb 2021; 14:431-440
Lee SJ, Cho JY, Kim BK, Yun KH, ... Jang Y, TICO Investigators
JACC Cardiovasc Interv: 21 Feb 2021; 14:431-440 | PMID: 33602439
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Abstract

Outcomes of Operator-Directed Sedation and Anesthesiologist Care in the Pediatric/Congenital Catheterization Laboratory: A Study Utilizing Data From the IMPACT Registry.

O\'Byrne ML, Kennedy KF, Steven JM, Hill KD, ... Rome JJ, Glatz AC
Objectives
The objective of this study was to assess contemporary use of operator directed sedation (ODS) and anesthesiologist care (AC) in the pediatric/congenital cardiac catheterization laboratory (PCCL), specifically evaluating whether the use of operator-directed sedation was associated with increased risk of major adverse events.
Background
The safety of ODS relative to AC during PCCL procedures has been questioned.
Methods
A multicenter, retrospective cohort study was performed studying procedures habitually performed with ODS or AC at IMPACT (Improving Adult and Congenital Treatment) registry hospitals using ODS for ≥5% of cases. The risks for major adverse events (MAE) for ODS and AC cases were compared, adjusted for case mix. Current recommendations were evaluated by comparing the ratio of observed to expected MAE for cases in which ODS was inappropriate (inconsistent with those guidelines) with those for similar risk AC cases, as well as those in which ODS or AC was appropriate.
Results
Of the hospitals submitting data to IMPACT, 28 of 101 met inclusion criteria. Of the 7,042 cases performed using ODS at these centers, 88% would be inappropriate. Use of ODS was associated with lower likelihood of MAE both in observed results (p < 0.0001) and after adjusting for case-mix (odds ratio: 0.81; p = 0.006). Use of AC was also associated with longer adjusted fluoroscopy and procedure times (p < 0.0001 for both). The observed/expected ratio for ODS cases with high pre-procedural risk (inappropriate for ODS) was significantly lower than that for AC cases with comparable pre-procedural risk. Across a range of pre-procedural risks, there was no stratum in which risk for MAE was lower for AC than ODS.
Conclusions
Across a range of hospitals, ODS was used safely and with improved efficiency. Clinical judgment better identified cases in which ODS could be used than pre-procedural risk score. This should inform future guidelines for the use of ODS and AC in the catheterization laboratory.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 21 Feb 2021; 14:401-413
O'Byrne ML, Kennedy KF, Steven JM, Hill KD, ... Rome JJ, Glatz AC
JACC Cardiovasc Interv: 21 Feb 2021; 14:401-413 | PMID: 33602437
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Abstract

Hemoglobin A and Cardiovascular Outcomes Following Percutaneous Coronary Intervention: Insights From a Large Single-Center Registry.

Baber U, Azzalini L, Masoomi R, Johal G, ... Kini AS, Sharma SK
Objectives
The aim of this study was to evaluate post-percutaneous coronary intervention (PCI) outcomes in relation to pre-procedural glycated hemoglobin (HbA1c) levels from a large, contemporary cohort.
Background
There are limited data evaluating associations between HbA1c, a marker of glycemic control, and ischemic risk following PCI.
Methods
All patients with known HbA1c levels undergoing PCI at a single institution between 2009 and 2017 were included. Patients were divided into 5 groups on the basis of HbA1c level: ≤5.5%, 5.6% to 6.0%, 6.1% to 7.0%, 7.1% to 8.0%, and >8.0%. The primary endpoint was major adverse cardiac events (MACE), a composite of all-cause death or myocardial infarction (MI), at 1-year follow-up.
Results
A total of 13,543 patients were included (HbA1c ≤5.5%, n = 1,214; HbA1c 5.6% to 6.0%, n = 2,202; HbA1c 6.1% to 7.0%, n = 4,130; HbA1c 7.1% to 8.0%, n = 2,609; HbA1c >8.0%, n = 3,388). Patients with both low (HbA1c ≤5.5%) and high (HbA1c >8.0%) levels displayed an increased risk for MACE compared with those with values between 6.1% and 7.0%. Excess risk was driven primarily by higher rates of all-cause death among those with low HbA1c levels, while higher values were strongly associated with greater MI risk. Patterns of risk were unchanged among patients with serial HbA1c levels and persisted after multivariate adjustment.
Conclusions
Among patients undergoing PCI, pre-procedural HbA1c levels display a U-shaped association with 1-year MACE risk, a pattern that reflects greater risk for death in the presence of low HbA1c (≤5.5%) and higher risk for MI with higher values (>8.0%).

Copyright © 2021. Published by Elsevier Inc.

JACC Cardiovasc Interv: 21 Feb 2021; 14:388-397
Baber U, Azzalini L, Masoomi R, Johal G, ... Kini AS, Sharma SK
JACC Cardiovasc Interv: 21 Feb 2021; 14:388-397 | PMID: 33602435
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Abstract

Distal Radial Artery Approach to Prevent Radial Artery Occlusion Trial.

Eid-Lidt G, Rivera Rodríguez A, Jimenez Castellanos J, Farjat Pasos JI, Estrada López KE, Gaspar J
Objectives
The aim of this study was to compare the rate of proximal radial artery occlusion (RAO) with Doppler ultrasound between distal and conventional radial access 24 h and 30 days after a transradial coronary procedure.
Background
The use of distal radial access to prevent proximal RAO (PRAO) in the proximal segment at 24 h and 30 days after a procedure, compared with conventional radial access, is unknown.
Methods
This was a prospective, comparative, longitudinal, randomized study. A total of 282 patients were randomized to either proximal radial access (n = 142) or distal radial access (n = 140) to evaluate the superiority of the distal approach in the prevention of PRAO with Doppler ultrasound 24 h and 30 days after a transradial coronary procedure.
Results
In the per protocol analysis, the rates of PRAO at 24 h and 30 days were 8.4% and 5.6% in the proximal group and 0.7% and 0.7% in the distal group, respectively (24 h: odds ratio [OR]: 12.8; 95% confidence interval [CI]: 1.6 to 100.0; p = 0.002; 30 days: OR: 8.2; 95% CI: 1.0 to 67.2; p = 0.019). In an intention-to-treat analysis, the 24-h and 30-day rates of PRAO were 8.8% and 6.4% for proximal radial access and 1.2% and 0.6% in the distal radial access group (24 h: OR: 7.4; 95% CI: 1.6 to 34.3; p = 0.003; 30 days: OR: 10.6; 95% CI: 1.3 to 86.4; p = 0.007).
Conclusions
Distal radial access prevents RAO in the proximal segment at 24 h and 30 days after the procedure compared with conventional radial access.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 21 Feb 2021; 14:378-385
Eid-Lidt G, Rivera Rodríguez A, Jimenez Castellanos J, Farjat Pasos JI, Estrada López KE, Gaspar J
JACC Cardiovasc Interv: 21 Feb 2021; 14:378-385 | PMID: 33602433
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Abstract

Access-Site Crossover in Patients With Acute Coronary Syndrome Undergoing Invasive Management.

Gragnano F, Branca M, Frigoli E, Leonardi S, ... Valgimigli M, MATRIX Trial Investigators
Objectives
The aim of this study was to assess the impact of access-site crossover in patients with acute coronary syndrome undergoing invasive management via radial or femoral access.
Background
There are limited data on the clinical implications of access-site crossover.
Methods
In the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox)-Access trial, 8,404 patients with acute coronary syndrome were randomized to radial or femoral access. Patients undergoing access-site crossover or successful access site were investigated. Thirty-day coprimary outcomes were a composite of death, myocardial infarction, or stroke (major adverse cardiovascular events [MACE]) and a composite of MACE or Bleeding Academic Research Consortium type 3 or 5 bleeding (net adverse clinical events [NACE]).
Results
Access-site crossover occurred in 183 of 4,197 patients (4.4%) in the radial group (mainly to femoral access) and 108 of 4,207 patients (2.6%) in the femoral group (mainly to radial access). In multivariate analysis, the risk for coprimary outcomes was not significantly higher with radial crossover compared with successful radial (MACE: adjusted rate ratio [adjRR]: 1.25; 95% confidence interval [CI]: 0.81 to 1.93; p = 0.32; NACE: adjRR: 1.40; 95% CI: 0.94 to 2.06; p = 0.094) or successful femoral access (MACE: adjRR: 1.17; 95% CI: 0.76 to 1.81; p = 0.47; NACE: adjRR: 1.26; 95% CI: 0.86 to 1.86; p = 0.24). Access site-related Bleeding Academic Research Consortium type 3 or 5 bleeding was higher with radial crossover than successful radial access. Femoral crossover remained associated with higher risks for MACE (adjRR: 1.84; 95% CI: 1.18 to 2.87; p = 0.007) and NACE (adjRR: 1.69; 95% CI: 1.09 to 2.62; p = 0.019) compared with successful femoral access. Results remained consistent after excluding patients with randomized access not attempted.
Conclusions
Crossover from radial to femoral access abolishes the bleeding benefit offered by the radial over femoral artery but does not appear to increase the risk for MACE or NACE compared with successful radial or femoral access. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox [MATRIX]; NCT01433627).

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 21 Feb 2021; 14:361-373
Gragnano F, Branca M, Frigoli E, Leonardi S, ... Valgimigli M, MATRIX Trial Investigators
JACC Cardiovasc Interv: 21 Feb 2021; 14:361-373 | PMID: 33602431
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Abstract

Impact of Coronary Artery Tortuosity on Outcomes Following Stenting: A Pooled Analysis From 6 Trials.

Konigstein M, Ben-Yehuda O, Redfors B, Mintz GS, ... Leon MB, Stone GW
Objectives
The authors sought to determine whether coronary artery tortuosity negatively affects clinical outcomes after stent implantation.
Background
Coronary artery tortuosity is a common angiographic finding and has been associated with increased rates of early and late major adverse events after balloon angioplasty.
Methods
Individual patient data from 6 prospective, randomized stent trials were pooled. Outcomes at 30 days and 5 years following percutaneous coronary intervention of a single coronary lesion were analyzed according to the presence or absence of moderate/severe vessel tortuosity, as determined by an angiographic core laboratory. The primary endpoint was target vessel failure (TVF; composite of cardiac death, target vessel-related myocardial infarction [TV-MI], or ischemia-driven target vessel revascularization [ID-TVR]).
Results
A total of 6,951 patients were included, 729 of whom (10.5%) underwent percutaneous coronary intervention in vessels with moderate/severe tortuosity. At 30 days, TVF was more frequent in patients with versus without moderate/severe tortuosity (3.8% vs. 2.4%, hazard ratio: 1.64, 95% confidence interval: 1.09 to 2.46; p = 0.02), a difference driven by a higher rate of TV-MI. At 5 years, TVF remained increased in patients with moderate/severe tortuosity (p = 0.003), driven by higher rates of TV-MI (p = 0.003) and ID-TVR (p = 0.01). Definite stent thrombosis was also greater in patients with versus without moderate/severe tortuosity (1.9% vs. 1.0%, hazard ratio: 1.86, 95% confidence interval: 1.02 to 3.39; p = 0.04). After adjustment for baseline covariates, moderate/severe vessel tortuosity was independently associated with TV-MI and ID-TVR at 5 years (p = 0.04 for both).
Conclusions
Stent implantation in vessels with moderate/severe coronary artery tortuosity is associated with increased rates of TVF due to greater rates of TV-MI and ID-TVR.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 19 Feb 2021; epub ahead of print
Konigstein M, Ben-Yehuda O, Redfors B, Mintz GS, ... Leon MB, Stone GW
JACC Cardiovasc Interv: 19 Feb 2021; epub ahead of print | PMID: 33640388
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Abstract

Elective Percutaneous Coronary Intervention in Ambulatory Surgery Centers.

Li K, Kalwani NM, Heidenreich PA, Fearon WF
Objectives
The aim of this study was to explore characteristics and outcomes of patients undergoing elective percutaneous coronary intervention (PCI) in ambulatory surgery centers (ASCs).
Background
Little is known about patients who underwent ASC PCI before Medicare reimbursement was instituted in 2020.
Methods
Using commercial insurance claims from MarketScan, adults who underwent hospital outpatient department (HOPD) or ASC PCI for stable ischemic heart disease from 2007 to 2016 were studied. Propensity score analysis was used to measure the association between treatment setting and the primary composite outcome of 30-day myocardial infarction, bleeding complications, and hospital admission.
Results
The unmatched sample consisted of 95,492 HOPD and 849 ASC PCIs. Patients who underwent ASC PCI were more likely to be younger than 65 years, to live in the southern United States, and to have managed or consumer-driven health insurance. ASC PCI was also associated with decreased fractional flow reserve utilization (odds ratio [OR]: 0.31; 95% confidence interval [CI]: 0.20 to 0.48; p < 0.001). In unmatched, multivariate analysis, ASC PCI was associated with increased odds of the primary outcome (OR: 1.25; 95% CI: 1.01 to 1.56; p = 0.039) and bleeding complications (OR: 1.80; 95% CI: 1.11 to 2.90; p = 0.016). In propensity-matched analysis, ASC PCI was not associated with the primary outcome (OR: 1.23; 95% CI: 0.94 to 1.60; p = 0.124) but was significantly associated with increased bleeding complications (OR: 2.49; 95% CI: 1.25 to 4.95; p = 0.009).
Conclusions
Commercially insured patients undergoing ASC PCI were less likely to undergo fractional flow reserve testing and had higher odds of bleeding complications than HOPD-treated patients. Further study is warranted as Medicare ASC PCI volume increases.

Published by Elsevier Inc.

JACC Cardiovasc Interv: 07 Feb 2021; 14:292-300
Li K, Kalwani NM, Heidenreich PA, Fearon WF
JACC Cardiovasc Interv: 07 Feb 2021; 14:292-300 | PMID: 33183992
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Abstract

Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial.

Sista AK, Horowitz JM, Tapson VF, Rosenberg M, ... Benenati JF, EXTRACT-PE Investigators
Objectives
This study sought to prospectively evaluate the safety and efficacy of the Indigo aspiration system in submassive acute pulmonary embolism (PE).
Background
PE treatment with thrombolytics has bleeding risks. Aspiration thrombectomy can remove thrombus without thrombolytics, but data are lacking.
Methods
This study was a prospective, single-arm, multicenter study that enrolled patients with symptomatic acute PE ≤14 days, systolic blood pressure ≥90 mm Hg, and right ventricular-to-left ventricular (RV/LV) ratio >0.9. The primary efficacy endpoint was change in RV/LV ratio from baseline to 48 h post-procedure on core lab-adjudicated computed tomography angiography. The primary safety endpoint was a composite of 48-h major adverse events: device-related death, major bleeding, and device-related serious adverse events (clinical deterioration, pulmonary vascular, or cardiac injury). All sites received Institutional Review Board approval.
Results
A total of 119 patients (mean age 59.8 ± 15.0 years) were enrolled at 22 U.S. sites between November 2017 and March 2019. Median device insertion to removal time was 37.0 (interquartile range: 23.5 to 60.0) min. Two (1.7%) patients received intraprocedural thrombolytics. Mean RV/LV ratio reduction from baseline to 48 h post-procedure was 0.43 (95% confidence interval: 0.38 to 0.47; p < 0.0001). Two (1.7%) patients experienced 3 major adverse events. Rates of cardiac injury, pulmonary vascular injury, clinical deterioration, major bleeding, and device-related death at 48 h were 0%, 1.7%, 1.7%, 1.7%, and 0.8%, respectively.
Conclusions
In this prospective, multicenter study the Indigo aspiration system was associated with a significant reduction in the RV/LV ratio and a low major adverse event rate in submassive PE patients. Intraprocedural thrombolytic drugs were avoided in 98.3% of patients. (Evaluating the Safety and Efficacy of the Indigo aspiration system in Acute Pulmonary Embolism [EXTRACT-PE]; NCT03218566).

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 07 Feb 2021; 14:319-329
Sista AK, Horowitz JM, Tapson VF, Rosenberg M, ... Benenati JF, EXTRACT-PE Investigators
JACC Cardiovasc Interv: 07 Feb 2021; 14:319-329 | PMID: 33454291
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Abstract

Acute Kidney Injury Following In-Patient Lower Extremity Vascular Intervention: From the National Cardiovascular Data Registry.

Safley DM, Salisbury AC, Tsai TT, Secemsky EA, ... Prasad A, Spertus JA
Objectives
The authors analyzed data from the NCDR (National Cardiovascular Data Registry) PVI Registry and defined acute kidney injury (AKI) as increased creatinine of ≥0.3 mg/dl or 50%, or a new requirement for dialysis after PVI.
Background
AKI is an important and potentially modifiable complication of peripheral vascular intervention (PVI). The incidence, predictors, and outcomes of AKI after PVI are incompletely characterized.
Methods
A hierarchical logistic regression risk model using pre-procedural characteristics associated with AKI was developed, followed by bootstrap validation. The model was validated with data submitted after model creation. An integer scoring system was developed to predict AKI after PVI.
Results
Among 10,006 procedures, the average age of patients was 69 years, 58% were male, and 52% had diabetes. AKI occurred in 737 (7.4%) and was associated with increased in-hospital mortality (7.1% vs. 0.7%). Reduced glomerular filtration rate, hypertension, diabetes, prior heart failure, critical or acute limb ischemia, and pre-procedural hemoglobin were independently associated with AKI. The model to predict AKI showed good discrimination (optimism corrected c-statistic = 0.68) and calibration (corrected slope = 0.97, intercept of -0.07). The integer point system could be incorporated into a useful clinical tool because it discriminates risk for AKI with scores ≤4 and ≥12 corresponding to the lower and upper 20% of risk, respectively.
Conclusions
AKI is not rare after PVI and is associated with in-hospital mortality. The NCDR PVI AKI risk model, including the integer scoring system, may prospectively estimate AKI risk and aid in deployment of strategies designed to reduce risk of AKI after PVI.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 07 Feb 2021; 14:333-341
Safley DM, Salisbury AC, Tsai TT, Secemsky EA, ... Prasad A, Spertus JA
JACC Cardiovasc Interv: 07 Feb 2021; 14:333-341 | PMID: 33541543
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Abstract

Comprehensive Assessment of Human Accessory Renal Artery Periarterial Renal Sympathetic Nerve Distribution.

Sato Y, Kawakami R, Jinnouchi H, Sakamoto A, ... Virmani R, Finn AV
Objectives
The aim of this study was to understand the anatomy of periarterial nerve distribution in human accessory renal arteries (ARAs).
Background
Renal denervation is a promising technique for blood pressure control. Despite the high prevalence of ARAs, the anatomic distribution of periarterial nerves around ARAs remains unknown.
Methods
Kidneys with surrounding tissues were collected from human autopsy subjects, and histological evaluation was performed using morphometric software. An ARA was defined as an artery arising from the aorta above or below the dominant renal artery (DRA) or an artery that bifurcated within 20 mm of the takeoff of the DRA from the aorta. The DRA was defined as an artery that perfused >50% of the kidney.
Results
A total of 7,287 nerves from 14 ARAs and 9 DRAs were evaluated. The number of nerves was smaller in the ARA than DRA (median: 30 [interquartile range: 17.5 to 48.5] vs. 49 [interquartile range: 36 to 76]; p < 0.0001). In both ARAs and DRAs, the distance from the arterial lumen to nerve was shortest in the distal, followed by the middle and proximal segments. On the basis of the post-mortem angiography, ARAs were divided into large (≥3 mm diameter) and small (<3 mm) groups. The number of nerves was greatest in the DRA, followed by the large and small ARA groups (53 [41 to 97], 38 [25 to 53], and 24.5 [10.5 to 36.3], respectively; p = 0.001).
Conclusions
ARAs showed a smaller number of nerves than DRAs, but these results were dependent on the size of the ARA. Ablation, especially in large ARAs, may allow more complete denervation with the potential to further reduce blood pressure.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 07 Feb 2021; 14:304-315
Sato Y, Kawakami R, Jinnouchi H, Sakamoto A, ... Virmani R, Finn AV
JACC Cardiovasc Interv: 07 Feb 2021; 14:304-315 | PMID: 33541541
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Abstract

Association of Acute Procedural Results With Long-Term Outcomes After CTO PCI.

Guan C, Yang W, Song L, Chen J, ... Brilakis ES, Xu B
Objectives
The aim of this study was to determine the association of procedural outcomes with long-term mortality and myocardial infarction (MI) after chronic total occlusion (CTO) percutaneous coronary intervention (PCI).
Background
The association between acute procedural results and subsequent outcomes has received limited study.
Methods
Between January 2010 and December 2013, a total of 2,659 CTO PCI patients were consecutively enrolled. Procedural results were categorized into 3 groups: 1) optimal recanalization, with reperfusion of the occluded vessel and side branches (if any) with TIMI (Thrombolysis In Myocardial Infarction) flow grade 3; 2) suboptimal recanalization, meeting any of the following criteria: persistence of significant side branch occlusion, final TIMI flow grade 1 or 2, or residual percentage diameter stenosis >30%; and 3) procedural failure (i.e., failure to cross a lesion with a balloon angioplasty catheter). The primary outcome was the 5-year composite endpoint of cardiac death and MI.
Results
Overall, optimal recanalization was achieved in 1,562 patients (58.7%), suboptimal recanalization was achieved in 399 patients (15.0%), and recanalization failed in 698 patients (26.3%). The 5-year incidence of the primary outcome was significantly higher in the suboptimal recanalization group compared with the optimal recanalization and the failure groups (10.1% vs. 6.5% vs. 6.3%; p = 0.046), which was driven mainly by higher risk for MI. In subgroup analysis, significant side branch occlusion was associated with numerically higher risk for 5-year MI (hazard ratio: 1.55; 95% confidence interval: 0.99 to 2.43; p = 0.054).
Conclusions
In this large cohort of CTO PCI patients, suboptimal recanalization was associated with significantly higher long-term incidence of cardiac death and MI compared with optimal recanalization or procedural failure.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 07 Feb 2021; 14:278-288
Guan C, Yang W, Song L, Chen J, ... Brilakis ES, Xu B
JACC Cardiovasc Interv: 07 Feb 2021; 14:278-288 | PMID: 33541539
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Impact:
Abstract

Evaluating Out-of-Hospital 30-Day Mortality After Transfemoral Transcatheter Aortic Valve Replacement: An STS/ACC TVT Analysis.

Anwaruddin S, Desai ND, Vemulapalli S, Marquis-Gravel G, ... Kosinski A, Reardon MJ
Objectives
This study sought to better understand out-of-hospital 30-day mortality following transfemoral transcatheter aortic valve replacement (TAVR) and identify factors associated with poor outcomes.
Background
Despite improvements in outcomes with TAVR for severe aortic stenosis, out-of-hospital 30-day mortality has not been evaluated.
Methods
This study examined patients in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry undergoing TAVR for severe aortic stenosis from January 2015 to March 2018. Primary and secondary endpoints were 30-day out-of-hospital all-cause mortality and out-of-hospital cardiovascular mortality, respectively. Logistic regression models were used to assess association between pre-specified factors and endpoints.
Results
A total of 106,749 patients underwent TAVR and were eligible for analysis. Transfemoral TAVR was performed in 92.3% of patients. A total of 2,137 (2.2%) transfemoral patients died within 30 days of the procedure, and 623 (29%) patients of these patients experienced out-of-hospital 30-day mortality. Cardiovascular and pulmonary etiologies accounted for the majority of observed mortality. Multivariable regression analysis identified older age, gender, lower body surface area, lower left ventricular ejection fraction, lower hemoglobin, atrial fibrillation or flutter, severe lung disease, home oxygen use, lack of moderate-to-severe aortic insufficiency, urgent TAVR, lower Kansas City Cardiomyopathy Questionnaire score, longer hospital length of stay, and in-hospital complications as being independently associated with the primary endpoint. New onset or pre-existent atrial fibrillation or flutter was also independently associated with 30-day out-of-hospital cardiovascular mortality in the transfemoral population.
Conclusions
We identified 30-day all-cause mortality rate for TAVR of 2.2%. Approximately one-third of patients experienced out-of-hospital mortality at 30 days. Several factors were identified as being independently associated with 30-day out-of-hospital all-cause and cardiovascular mortality. Further work is needed to understand how best to improve out-of-hospital mortality following TAVR.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 07 Feb 2021; 14:261-274
Anwaruddin S, Desai ND, Vemulapalli S, Marquis-Gravel G, ... Kosinski A, Reardon MJ
JACC Cardiovasc Interv: 07 Feb 2021; 14:261-274 | PMID: 33541537
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Impact:
Abstract

3-Year Outcomes of the ULTIMATE Trial Comparing Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation.

Gao XF, Ge Z, Kong XQ, Kan J, ... Chen SL, ULTIMATE Investigators
Objectives
The aim of this study was to explore the difference in target vessel failure (TVF) 3 years after intravascular ultrasound (IVUS) guidance versus angiographic guidance among all comers undergoing second-generation drug-eluting stent (DES) implantation.
Background
The multicenter randomized ULTIMATE (Intravascular Ultrasound Guided Drug Eluting Stents Implantation in \"All-Comers\" Coronary Lesions) trial showed a lower incidence of 1-year TVF after IVUS-guided DES implantation among all comers compared with angiographic guidance. However, the 3-year clinical outcomes of the ULTIMATE trial remain unknown.
Methods
A total of 1,448 all comers undergoing DES implantation who were randomly assigned to either IVUS guidance or angiographic guidance in the ULTIMATE trial were followed for 3 years. The primary endpoint was the risk for TVF at 3 years. The safety endpoint was definite or probable stent thrombosis (ST).
Results
At 3 years, TVF occurred in 47 patients (6.6%) in the IVUS-guided group and in 76 patients (10.7%) in the angiography-guided group (p = 0.01), driven mainly by the decrease in clinically driven target vessel revascularization (4.5% vs. 6.9%; p = 0.05). The rate of definite or probable ST was 0.1% in the IVUS-guided group and 1.1% in the angiography-guided group (p = 0.02). Notably, the IVUS-defined optimal procedure was associated with a significant reduction in 3-year TVF relative to that with the suboptimal procedure.
Conclusions
IVUS-guided DES implantation was associated with significantly lower rates of TVF and ST during 3-year follow-up among all comers, particularly those who underwent the IVUS-defined optimal procedure compared with those with angiographic guidance. (Intravascular Ultrasound Guided Drug Eluting Stents Implantation in \"All-Comers\" Coronary Lesions; NCT02215915).

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 07 Feb 2021; 14:247-257
Gao XF, Ge Z, Kong XQ, Kan J, ... Chen SL, ULTIMATE Investigators
JACC Cardiovasc Interv: 07 Feb 2021; 14:247-257 | PMID: 33541535
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Impact:
Abstract

Invasive Coronary Physiology After Stent Implantation: Another Step Toward Precision Medicine.

Biscaglia S, Uretsky B, Barbato E, Collet C, ... Stone GW, Campo G
Intracoronary physiology is routinely used in setting the indication for percutaneous coronary intervention (PCI) but seldom in assessing procedural results. This attitude is increasingly challenged by accumulated evidence demonstrating the value of post-PCI functional assessment in predicting long-term patient outcomes. Besides fractional flow reserve, a number of new indexes recently incorporated to clinical practice, including nonhyperemic pressure and functional angiographic indexes, provide new opportunities for the physiological assessment of PCI results. Largely, the benefit of these tools is derived from longitudinal analysis of the treated vessel, which allows precise identification of the vessel segment accounting for a suboptimal functional result and enabling operators to perform accurate PCI optimization. In this document the authors review available evidence supporting why physiological assessment should be extended to immediate post-PCI with the aim of improving patient outcomes. A step-by-step guide on how available physiological tools can be used for such purpose is provided.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 07 Feb 2021; 14:237-246
Biscaglia S, Uretsky B, Barbato E, Collet C, ... Stone GW, Campo G
JACC Cardiovasc Interv: 07 Feb 2021; 14:237-246 | PMID: 33541534
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Impact:
Abstract

Safety and Efficacy of Transcatheter Aortic Valve Replacement With Continuation of Vitamin K Antagonists or Direct Oral Anticoagulants.

Brinkert M, Mangner N, Moriyama N, Keller LS, ... Linke A, Toggweiler S
Objectives
This study investigated whether transcatheter aortic valve replacement (TAVR) with peri-procedural continuation of oral anticoagulation is equally safe and efficacious as TAVR with peri-procedural interruption of anticoagulation.
Background
A significant proportion of patients undergoing TAVR have an indication for long-term oral anticoagulation. The optimal peri-procedural management of such patients is unknown.
Methods
Consecutive patients on oral anticoagulation who underwent transfemoral TAVR at 5 European centers were enrolled. Oral anticoagulation was either stopped 2 to 4 days before TAVR or continued throughout the procedure. Primary safety outcome was major bleeding. Secondary efficacy endpoints included vascular complications, stroke, and mortality.
Results
Of 4,459 patients, 584 patients were treated with continuation of anticoagulation and 733 with interruption of anticoagulation. At 30 days, major or life-threatening bleedings occurred in 66 (11.3%) versus 105 (14.3%; odds ratio [OR]: 0.86; 95% confidence interval [CI]: 0.61 to 1.21; p = 0.39) and major vascular complications in 64 (11.0%) versus 90 (12.3%; OR: 0.89; CI: 0.62 to 1.27; p = 0.52) of patients with continuation and with interruption of anticoagulation, respectively. Transfusion of packed red blood cells was less often required in patients with continuation of anticoagulation (80 [13.7%] vs. 130 [17.7%]; OR: 0.59; 95% CI: 0.42 to 0.81; p = 0.001). Kaplan-Meier estimates of survival at 12 months were 85.3% in patients with continuation of anticoagulation and 84.0% in patients with interruption of anticoagulation (hazard ratio: 0.90; 95% CI: 0.73 to 1.12; p = 0.36).
Conclusions
Continuation of oral anticoagulation throughout TAVR did not increase bleeding or vascular complication rates. Moreover, packed red blood cell transfusions were less often required in patients with continuation of oral anticoagulation.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 24 Jan 2021; 14:135-144
Brinkert M, Mangner N, Moriyama N, Keller LS, ... Linke A, Toggweiler S
JACC Cardiovasc Interv: 24 Jan 2021; 14:135-144 | PMID: 33358653
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Impact:
Abstract

Suture- or Plug-Based Large-Bore Arteriotomy Closure: A Pilot Randomized Controlled Trial.

van Wiechen MP, Tchétché D, Ooms JF, Hokken TW, ... Dumonteil N, Van Mieghem NM
Objectives
This study sought to test the superiority in terms of efficacy and safety of a dedicated plug-based vascular closure device (VCD) during transcatheter aortic valve replacement (TAVR) over a suture-based VCD.
Background
Vascular complications after TAVR are relevant and often associated with VCD failure.
Methods
The MASH (MANTA vs. Suture-based vascular closure after transcatHeter aortic valve replacement) trial is an international, 2-center pilot randomized controlled trial comparing the MANTA VCD (Teleflex, Wayne, Pennsylvania) versus 2 ProGlides (Abbott Vascular, Abbott Park, Illinois). The primary composite endpoint consisted of access site-related major or minor vascular complications at 30-days\' follow-up. Secondary endpoints included clinically relevant access site bleeding, time to hemostasis, and modified VCD failure (defined as failure to achieve hemostasis within 5 min or requiring additional endovascular maneuvers such as endovascular stenting, surgical techniques, or additional closure devices). Adverse events were adjudicated by an independent clinical events committee according to the VARC-2 definitions.
Results
A total of 210 TAVR patients were included between October 2018 and January 2020. Median age was 81 years, 54% were male, and the median STS score was 2.7%. There was no significant difference in the primary endpoint of access site-related vascular complications between MANTA and ProGlide (10% vs. 4%; p = 0.16). Clinically significant access site bleedings were similar with both closure techniques (9% vs. 6%; p = 0.57). Modified VCD failure occurred less frequently in MANTA versus ProGlide (20% vs. 40%; p < 0.01). Suture-based closure required more often additional closure devices, whereas MANTA numerically needed more covered stents and surgical bailouts.
Conclusions
Plug-based large-bore arteriotomy closure was not superior to suture-based closure. Plug-based closure required fewer, but a different kind of bailout maneuvers.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 24 Jan 2021; 14:149-157
van Wiechen MP, Tchétché D, Ooms JF, Hokken TW, ... Dumonteil N, Van Mieghem NM
JACC Cardiovasc Interv: 24 Jan 2021; 14:149-157 | PMID: 33358648
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Impact:
Abstract

Valve-in-Valve Transcatheter Aortic Valve Replacement Versus Redo Surgical Aortic Valve Replacement: An Updated Meta-Analysis.

Sá MPBO, Van den Eynde J, Simonato M, Cavalcanti LRP, ... Pibarot P, Clavel MA
Objectives
The aim of this study was to evaluate early results of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) versus redo surgical aortic valve replacement (SAVR) for structural valve degeneration (SVD).
Background
ViV TAVR has been increasingly used for SVD, but it remains unknown whether it produces better or at least comparable results as redo SAVR.
Methods
Observational studies comparing ViV TAVR and redo SAVR were identified in a systematic search of published research. Random-effects meta-analysis was performed, comparing clinical outcomes between the 2 groups.
Results
Twelve publications including a total of 16,207 patients (ViV TAVR, n = 8,048; redo SAVR, n = 8,159) were included from studies published from 2015 to 2020. In the pooled analysis, ViV TAVR was associated with lower rates of 30-day mortality overall (odds ratio [OR]: 0.53; 95% confidence interval [CI]: 0.32 to 0.87; p = 0.017) and for matched populations (OR: 0.419; 95% CI: 0.278 to 0.632; p = 0.003), stroke (OR: 0.65; 95% CI: 0.55 to 0.76; p < 0.001), permanent pacemaker implantation (OR: 0.73; 95% CI: 0.22 to 2.43; p = 0.536), and major bleeding (OR: 0.49; 95% CI: 0.26 to 0.93; p = 0.034), as well as with shorter hospital stay (OR: -3.30; 95% CI: -4.52 to -2.08; p < 0.001). In contrast, ViV TAVR was associated with higher rates of myocardial infarction (OR: 1.50; 95% CI: 1.01 to 2.23; p = 0.045) and severe patient-prosthesis mismatch (OR: 4.63; 95% CI: 3.05 to 7.03; p < 0.001). The search revealed an important lack of comparative studies with long-term results.
Conclusions
ViV TAVR is a valuable option in the treatment of patients with SVD because of its lower incidence of post-operative complications and better early survival compared with redo SAVR. However, ViV TAVR is associated with higher rates of myocardial infarction and severe patient-prosthesis mismatch.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 24 Jan 2021; 14:211-220
Sá MPBO, Van den Eynde J, Simonato M, Cavalcanti LRP, ... Pibarot P, Clavel MA
JACC Cardiovasc Interv: 24 Jan 2021; 14:211-220 | PMID: 33478639
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Abstract

Unplanned Percutaneous Coronary Revascularization After TAVR: A Multicenter International Registry.

Stefanini GG, Cerrato E, Pivato CA, Joner M, ... Nombela-Franco L, REVIVAL Investigators
Objectives
This study sought to evaluate the incidence and causes of percutaneous coronary intervention (PCI) at different time periods following transcatheter aortic valve replacement (TAVR).
Background
Coronary artery disease (CAD) and aortic stenosis frequently coexist, but the optimal management of CAD following TAVR remains incompletely elucidated.
Methods
Patients undergoing unplanned PCI after TAVR were retrospectively included in an international multicenter registry.
Results
Between July 2008 and March 2019, a total of 133 patients (0.9%; from a total cohort of 15,325) underwent unplanned PCI after TAVR (36.1% after balloon-expandable bioprosthesis, 63.9% after self-expandable bioprosthesis). The median time to PCI was 191 days (interquartile range: 59 to 480 days). The daily incidence of PCI was highest during the first week after TAVR and then declined over time. Overall, the majority of patients underwent PCI due to an acute coronary syndrome, and specifically 32.3% had non-ST-segment elevation myocardial infarction, 15.4% had unstable angina, 9.8% had ST-segment elevation myocardial infarction, and 2.2% had cardiac arrest. However, chronic coronary syndromes are the main indication beyond 2 years. PCI success was reported in almost all cases (96.6%), with no significant differences between patients treated with balloon-expandable and self-expandable bioprostheses (100% vs. 94.9%; p = 0.150).
Conclusions
Unplanned PCI after TAVR is rare, with an incidence declining over time after TAVR. The main indication to PCI is acute coronary syndrome in the first 2 years after TAVR, and thereafter chronic coronary syndromes become prevalent. Unplanned PCIs are frequently successfully performed after TAVR, with no apparent differences between balloon-expandable and self-expandable bioprostheses. (Revascularization After Transcatheter Aortic Valve Implantation [REVIVAL]; NCT03283501).

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 24 Jan 2021; 14:198-207
Stefanini GG, Cerrato E, Pivato CA, Joner M, ... Nombela-Franco L, REVIVAL Investigators
JACC Cardiovasc Interv: 24 Jan 2021; 14:198-207 | PMID: 33478637
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Impact:
Abstract

Double S-Curve Versus Cusp-Overlap Technique: Defining the Optimal Fluoroscopic Projection for TAVR With a Self-Expanding Device.

Ben-Shoshan J, Alosaimi H, Lauzier PT, Pighi M, ... Gada H, Piazza N
Objectives
The purpose of this study was to assess the concordance between transcatheter aortic valve implantation angles generated by the \"double S-curve\" and \"cusp-overlap\" techniques.
Background
The \"double S-curve\" and \"cusp-overlap\" methods aim to define optimal fluoroscopic projections for transcatheter aortic valve replacement (TAVR) with a self-expandable device.
Methods
The study included 100 consecutive patients undergoing TAVR with self-expanding device planned by multidetector computed tomography. TAVR was performed using the double S-curve model, as a view in which both the aortic valve annulus and delivery catheter planes are displayed perpendicularly on fluoroscopy. Optimal projection according to the cusp-overlap technique was retrospectively generated by overlapping the right and left cups on the multidetector computed tomography annular plane. The angular difference between methods was assessed in spherical 3 dimensions and on the left and right anterior oblique (RAO) and cranial and caudal (CAU) axes.
Results
The double S-curve and cusp-overlap methods provided views located in the same quadrant, mostly the RAO and CAU, in 92% of patients with a median 3-dimensional angular difference of 10.0° (interquartile range: 5.5° to 17.9°). The 3-dimensional deviation between the average angulation obtained by each method was not statistically significant (1.49°; p = 0.349). No significant differences in average coordinates were noted between the double S-curve and cusp-overlap methods (RAO: 14.7 ± 15.2 vs. 12.9 ± 12.5; p = 0.36; and CAU: 27.0 ± 9.4 vs. 26.9 ± 10.4; p = 0.90). TAVR using the double S-curve was associated with 98% device success, low complication rate, and absence of moderate-to-severe paravalvular leak.
Conclusions
The double S-curve and cusp-overlap methods provide comparable TAVR projections, mostly RAO and CAU. TAVR using the double S-curve model is associated with a high rate of device success and low rate of procedural complications.

Copyright © 2021. Published by Elsevier Inc.

JACC Cardiovasc Interv: 24 Jan 2021; 14:185-194
Ben-Shoshan J, Alosaimi H, Lauzier PT, Pighi M, ... Gada H, Piazza N
JACC Cardiovasc Interv: 24 Jan 2021; 14:185-194 | PMID: 33478635
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Impact:
Abstract

Transcatheter Aortic Valve Replacement With the LOTUS Edge System: Early European Experience.

Armario X, Rosseel L, Kharbanda R, Khogali S, ... Blackman DJ, Mylotte D
Objectives
The aim of this study was to evaluate the short-term safety and efficacy of transcatheter aortic valve replacement (TAVR) with the LOTUS Edge system.
Background
The LOTUS Edge system was commercially re-released in April 2019. The authors report the first European experience with this device.
Methods
A multicenter, single-arm, retrospective registry was initiated to evaluate short-term clinical outcomes. Included cases are the first experience with this device and new implantation technique in Europe. Clinical, echocardiographic, and computed tomographic data were analyzed. Endpoints were defined according to Valve Academic Research Consortium-2 and were site reported.
Results
Between April and November 2019, 286 consecutive patients undergoing TAVR with the LOTUS Edge system at 18 European centers were included. The mean age and Society of Thoracic Surgeons score were 81.2 ± 6.9 years and 5.2 ± 5.4%, respectively. Nearly one-half of all patients (47.9%) were considered to have complex anatomy. Thirty-day major adverse events included death (2.4% [n = 7]) and stroke (3.5% [n = 10]). After TAVR, the mean aortic valve area was 1.9 ± 0.9 cm2, and the mean transvalvular gradient was 11.9 ± 5.7 mm Hg. None or trace paravalvular leak (PVL) occurred in 84.4% and moderate PVL in 2.0%. There were no cases of severe PVL. New permanent pacemaker (PPM) implantation was required in 25.9% among all patients and 30.8% among PPM-naive patients.
Conclusions
Early experience with the LOTUS Edge system demonstrated satisfactory short-term safety and efficacy, favorable hemodynamic data, and very low rates of PVL in an anatomically complex cohort. New PPM implantation remained high. Further study will evaluate if increasing operator experience with the device and new implantation technique can reduce the incidence of PPM implantation.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 24 Jan 2021; 14:172-181
Armario X, Rosseel L, Kharbanda R, Khogali S, ... Blackman DJ, Mylotte D
JACC Cardiovasc Interv: 24 Jan 2021; 14:172-181 | PMID: 33478633
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Impact:
Abstract

The Use and Outcomes of Cerebral Protection Devices for Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement in Clinical Practice.

Stachon P, Kaier K, Heidt T, Wolf D, ... Bode C, von Zur Mühlen C
Objectives
This study hypothesized that cerebral protection prevents strokes in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) in clinical practice.
Background
Preventing strokes is an important aim in TAVR procedures. Embolic protection devices may protect against cardiac embolism during TAVR, but their use and outcomes in clinical practice remain controversial.
Methods
Isolated transfemoral TAVR procedures performed in Germany with or without cerebral protection devices were extracted from a comprehensive nationwide billing dataset.
Results
A total of 41,654 TAVR procedures performed between 2015 and 2017 were analyzed. The overall share of procedures incorporating cerebral protection devices was 3.8%. Patients receiving cerebral protection devices were at increased operative risk (European System for Cardiac Operative Risk Evaluation score 13.8 vs. 14.7; p < 0.001) but of lower age (81.1 vs. 80.6 years; p = 0.001). To compare outcomes that may be related to the use of cerebral protection devices, a propensity score comparison was performed. The use of a cerebral protection device did not reduce the risk for stroke (adjusted risk difference [aRD]: +0.88%; 95% confidence interval [CI]: -0.07% to 1.83%; p = 0.069) or the risk for developing delirium (aRD: +1.31%; 95% CI: -0.28% to 2.89%; p = 0.106) as a sign of acute brain failure. Although brain damage could not be prevented, in-hospital mortality was lower in the group receiving a cerebral protection device (aRD: -0.76%; 95% CI: -1.46% to -0.06%; p = 0.034).
Conclusions
In this large national database, cerebral embolic protection devices were infrequently used during TAVR procedures. Device use was associated with lower mortality but not a reduction in stroke or delirium. Future studies are needed to confirm these findings.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 24 Jan 2021; 14:161-168
Stachon P, Kaier K, Heidt T, Wolf D, ... Bode C, von Zur Mühlen C
JACC Cardiovasc Interv: 24 Jan 2021; 14:161-168 | PMID: 33478631
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Impact:
Abstract

Incidence, Predictors, and Implications of Permanent Pacemaker Requirement After Transcatheter Aortic Valve Replacement.

Sammour Y, Krishnaswamy A, Kumar A, Puri R, ... Wazni O, Kapadia SR
Transcatheter aortic valve replacement (TAVR) is a safe and feasible alternative to surgery in patients with symptomatic severe aortic stenosis regardless of the surgical risk. Conduction abnormalities requiring permanent pacemaker (PPM) implantation remain a common finding after TAVR due to the close proximity of the atrioventricular conduction system to the aortic root. High-grade atrioventricular block and new onset left bundle branch block (LBBB) are the most commonly reported conduction abnormalities after TAVR. The overall rate of PPM implantation after TAVR varies and is related to pre-procedural and intraprocedural factors. The available literature regarding the impact of conduction abnormalities and PPM requirement on morbidity and mortality is still conflicting. Pre-procedural conduction abnormalities such as right bundle branch block and LBBB have been linked with increased PPM implantation and mortality after TAVR. When screening patients for TAVR, heart teams should be aware of various anatomical and pathophysiological conditions that make patients more susceptible to increased risk of conduction abnormalities and PPM requirement after the procedure. This is particularly important as TAVR has been recently approved for patients with low surgical risk. The purpose of this review is to discuss the incidence, predictors, impact, and management of the various conduction abnormalities requiring PPM implantation in patients undergoing TAVR.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 24 Jan 2021; 14:115-134
Sammour Y, Krishnaswamy A, Kumar A, Puri R, ... Wazni O, Kapadia SR
JACC Cardiovasc Interv: 24 Jan 2021; 14:115-134 | PMID: 33478630
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Impact:

This program is still in alpha version.