Journal: JACC Cardiovasc Interv

Sorted by: date / impact
Abstract

Prevention of Radial Artery Occlusion of 3 Hemostatic Methods in Transradial Intervention for Coronary Angiography.

Eid-Lidt G, Reyes-Carrera J, Farjat-Pasos JI, Saenz AL, ... Soto-López ME, Gaspar J
Objectives
The main objective of this study was to compare the efficacy of 3 hemostatic methods for the prevention of early radial artery occlusion (RAO): standard patent hemostasis, patent hemostasis with ulnar compression or the ulnar artery transient compression facilitating radial artery patent hemostasis (ULTRA) method, and facilitated hemostasis with a hemostatic disc.
Background
There are no prospective randomized studies that compare early RAO rates with the 3 most used nonocclusive hemostatic methods.
Methods
This was a prospective, longitudinal, comparative, and randomized study. The final population analyzed was 1,469, and they were randomized into 3 groups: 491 patients in group 1 with standard patent hemostasis, 490 patients in group 2 with the ULTRA method, and 488 patients in group 3 with facilitated hemostasis with a hemostatic disc.
Results
The RAO rate at 24 hours of the total population analyzed was 4.6%. By hemostasis groups, it was 3.6% for patent hemostasis, 5.5% for the ULTRA method, and 4.7% for facilitated hemostasis with a hemostatic disc, with no statistical difference among the 3 groups (P = 0.387). At 30 days, the overall rate of RAO was 1.8%, and by groups, it was 1.4% for the patent hemostasis group, 1.8% for the ULTRA method group, and 2.2% for the facilitated hemostasis with a hemostatic disc group, respectively (P = 0.185).
Conclusions
The rates of RAO at 24 hours evaluated by plethysmography oximetry and confirmed by ultrasound among 3 current radial hemostasis methods (ie, patent hemostasis, the ULTRA method, and facilitated hemostasis with a hemostatic disc) are not different.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 23 May 2022; 15:1022-1029
Eid-Lidt G, Reyes-Carrera J, Farjat-Pasos JI, Saenz AL, ... Soto-López ME, Gaspar J
JACC Cardiovasc Interv: 23 May 2022; 15:1022-1029 | PMID: 35589232
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Abstract

Combined Assessment of FFR and CFR for Decision Making in Coronary Revascularization: From the Multicenter International ILIAS Registry.

van de Hoef TP, Lee JM, Boerhout CKM, de Waard GA, ... Koo BK, Piek JJ
Objectives
The aim of this study was to demonstrate the clinical implications of combined assessment of fractional flow reserve (FFR) and coronary flow reserve (CFR).
Background
Combined assessment of FFR and CFR allows detailed characterization of pathophysiology in chronic coronary syndromes. Data on the clinical implications of distinct FFR and CFR patterns are limited, leading to uncertainty regarding their relevance.
Methods
Patients with chronic coronary syndromes and obstructive coronary artery disease were selected from the multicenter ILIAS (Inclusive Invasive Physiological Assessment in Angina Syndromes) registry. Patients were classified into 4 groups on the basis of FFR ≤0.80 and CFR <2.0. The endpoint was the 5-year target vessel failure (TVF) rate.
Results
A total of 2,143 patients with 2,725 lesions were included. Compared with normal FFR/normal CFR, low FFR/low CFR carried the highest risk for TVF (HR: 5.4; 95% CI: 3.2-9.3; P < 0.001), significantly higher than in revascularized vessels (P = 0.007). Discordance, with either low FFR/normal CFR or normal FFR/low CFR, was associated with increased TVF rates compared with normal FFR/normal CFR (low FFR/normal CFR: HR: 3.5 [95% CI: 2.2-5.4; P < 0.001]; normal FFR/low CFR: HR: 3.0 [95% CI: 1.9-4.7; P < 0.001]). No difference in 5-year TVF was observed between the 2 discordant groups (P = 0.57) or between the discordant groups and the revascularized group (P = 0.26 vs low FFR/normal CFR; P = 0.60 vs normal FFR/low CFR).
Conclusions
Impaired coronary hemodynamics are uniformly associated with increased 5-year TVF rates. Nonrevascularized vessels with discordant FFR and CFR are associated with 5-year event rates that are equivalent to those of vessels that undergo revascularization, whereas vessels with combined low FFR and CFR exhibit event rates that are significantly higher than after revascularization. (Inclusive Invasive Physiological Assessment in Angina Syndromes Registry [ILIAS Registry]; NCT04485234).

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 23 May 2022; 15:1047-1056
van de Hoef TP, Lee JM, Boerhout CKM, de Waard GA, ... Koo BK, Piek JJ
JACC Cardiovasc Interv: 23 May 2022; 15:1047-1056 | PMID: 35589234
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Abstract

Comparison of Doppler Flow Velocity and Thermodilution Derived Indexes of Coronary Physiology.

Demir OM, Boerhout CKM, de Waard GA, van de Hoef TP, ... Piek JJ, Perera D
Objectives
The aim of this study was to compare Doppler flow velocity and thermodilution-derived indexes and to determine the optimal thermodilution-based diagnostic thresholds for coronary flow reserve (CFR).
Background
The majority of clinical data and diagnostic thresholds for flow-based indexes are derived from Doppler measurements, and correspondence with thermodilution-derived indices remain unclear.
Methods
An international multicenter registry was conducted among patients who had coronary flow measurements using both Doppler and thermodilution techniques in the same vessel and during the same procedure.
Results
Physiological data from 250 vessels (in 149 patients) were included in the study. A modest correlation was found between thermodilution-derived CFR (CFRthermo) and Doppler-derived CFR (CFRDoppler) (r2 = 0.36; P < 0.0001). CFRthermo overestimated CFRDoppler (mean 2.59 ± 1.46 vs 2.05 ± 0.89; P < 0.0001; mean bias 0.59 ± 1.24 by Bland-Altman analysis), the relationship being described by the equation CFRthermo = 1.04 × CFRDoppler + 0.50. The commonly used dichotomous CFRthermo threshold of 2.0 had poor sensitivity at predicting a CFRDoppler value <2.5. The optimal CFRthermo threshold was 2.5 (sensitivity 75.54%, specificity 81.25%). There was only a weak correlation between hyperemic microvascular resistance and index of microvascular resistance (r2 = 0.19; P < 0.0001), due largely to variation in the measurement of flow by each modality. Forty-four percent of patients were discordantly classified as having abnormal microvascular resistance by hyperemic microvascular resistance (≥2.5 mm Hg · cm-1 · s) and index of microvascular resistance (≥25).
Conclusions
CFR calculated by thermodilution overestimates Doppler-derived CFR, while both parameters show modest correlation. The commonly used CFRthermo threshold of 2.0 has poor sensitivity for identifying vessels with diminished CFR, but using the same binary diagnostic threshold as for Doppler (<2.5) yields reasonable diagnostic accuracy. There was only a weak correlation between microvascular resistance indexes assessed by the 2 modalities.

Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 23 May 2022; 15:1060-1070
Demir OM, Boerhout CKM, de Waard GA, van de Hoef TP, ... Piek JJ, Perera D
JACC Cardiovasc Interv: 23 May 2022; 15:1060-1070 | PMID: 35589236
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Abstract

MIRACLE Score and SCAI Grade to Identify Patients With Out-of-Hospital Cardiac Arrest for Immediate Coronary Angiography.

Pareek N, Beckley-Hoelscher N, Kanyal R, Cannata A, ... Byrne J, MacCarthy P
Objectives
The purpose of this study was to evaluate the impact of performing immediate coronary angiography (CAG) after out-of-hospital cardiac arrest (OHCA) with stratification of predicted neurologic injury and cardiogenic shock on arrival to a center.
Background
The role of immediate CAG for patients with OHCA is unclear, which may in part be explained by the majority of patients dying of hypoxic brain injury.
Methods
Between May 2012 and July 2020, patients from 5 European centers were included in the EUCAR (European Cardiac Arrest Registry). Patients were retrospectively classified into low vs high neurologic risk (MIRACLE2 score 0-3 vs ≥4) and degree of cardiogenic shock on arrival (Society for Cardiovascular Angiography and Interventions [SCAI] grade A vs B-E). A multivariable logistic regression analysis including immediate CAG was performed for the primary outcome of survival with good neurologic outcome (Cerebral Performance Category 1 or 2) at hospital discharge.
Results
Nine hundred twenty-six patients were included in the registry, with 405 (43.7%) in the low-risk group and 521 (56.3%) in the high-risk group. Immediate CAG was independently associated with improved survival with good neurologic outcome in the low MIRACLE2 risk group with ST-segment elevation myocardial infarction (OR: 11.80; 95% CI: 2.24-76.74; P = 0.048) and with SCAI grade B to E shock (OR: 3.23; 95% CI: 1.10-9.50; P = 0.031). No subgroups, including those with ST-segment elevation myocardial infarction and with SCAI grade B to E shock, achieved any benefit from early CAG in the high MIRACLE2 group.
Conclusions
Combined classification of patients with OHCA with 12-lead electrocardiography, MIRACLE2 score 0 to 3, and SCAI grade B to E identifies a potential cohort of patients at low risk for neurologic injury who benefit most from immediate CAG.

Copyright © 2022. Published by Elsevier Inc.

JACC Cardiovasc Interv: 23 May 2022; 15:1074-1084
Pareek N, Beckley-Hoelscher N, Kanyal R, Cannata A, ... Byrne J, MacCarthy P
JACC Cardiovasc Interv: 23 May 2022; 15:1074-1084 | PMID: 35589238
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Abstract

Six-Month Outcomes of the TricValve® System in Patients with Tricuspid Regurgitation: TRICUS EURO Study.

Estévez-Loureiro R, Sánchez-Recalde A, Amat-Santos IJ, Cruz-González I, ... Puri R, Íñiguez-Romo A
Background
Severe tricuspid regurgitation (TR) is frequently associated with significant morbidity and mortality; such patients often deemed to be at high surgical risk. Heterotopic bi-caval stenting is an emerging, attractive transcatheter solution for these patients.
Objectives
To evaluate the 30-day safety and 6-month efficacy outcomes of specifically designed bioprosthetic valves for the superior and inferior vena cava.
Methods
TRICUS EURO is a non-blinded, non-randomized, single-arm, multicenter, prospective trial that enrolled patients from 12 European centers between December 2019 to February 2021. High risk individuals with severe symptomatic TR despite optimal medical therapy were included. Primary end point was quality of life (QOL) improvement measured by Kansas City Cardiomyopathy Questionnaire (KCCQ12) and New York Heart Association functional class (NYHA) improvement at 6-month follow-up.
Results
35 patients (mean age 76±6.8 years; 83% women) were treated with TricValve® system. All patients at baseline were at NYHA ≥ 3 status. At 30-days, procedural success was 94% with no procedural deaths or conversions to surgery. A significant increase in QOL at 6-months follow-up was observed (baseline and 6-month KCCQ: 42.01±22.3 vs. 59.7±23.6 respectively; p=0.004), correlating with a significant improvement in NYHA functional class with 79.4% of patients noted to be in class I or II at 6 months (p=0.0006). The 6-month all-cause mortality and heart failure hospitalization rates were 8.5% and 20%, respectively.
Conclusions
The dedicated bi-caval system for treating severe, symptomatic TR was associated with high procedural success rate and significant increase in both, QOL and functional improvements at 6-months follow-up.

Copyright © 2022. Published by Elsevier Inc.

JACC Cardiovasc Interv: 12 May 2022; epub ahead of print
Estévez-Loureiro R, Sánchez-Recalde A, Amat-Santos IJ, Cruz-González I, ... Puri R, Íñiguez-Romo A
JACC Cardiovasc Interv: 12 May 2022; epub ahead of print | PMID: 35583363
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Abstract

Distal Versus Conventional Radial Access for Coronary Angiography and Intervention (DISCO RADIAL).

Aminian A, Sgueglia GA, Wiemer M, Kefer J, ... Tobita K, Saito S
Objectives
The aim of this study was to assess the superiority of DRA compared with conventional TRA with respect to forearm RAO.
Background
Currently, transradial access (TRA) is the recommended access for coronary procedures because of increased safety, with radial artery occlusion (RAO) being its most frequent complication, which will increasingly affect patients undergoing multiple procedures during their lifetimes. Recently, distal radial access (DRA) has emerged as a promising alternative access to minimize RAO risk. A large-scale, international, randomized trial comparing RAO with TRA and DRA is lacking.
Methods
DISCO RADIAL (Distal vs Conventional Radial Access) was an international, multicenter, randomized controlled trial in which patients with indications for percutaneous coronary procedure using a 6-F Slender sheath were randomized to DRA or TRA with systematic implementation of best practices to reduce RAO. The primary endpoint was the incidence of forearm RAO assessed by vascular ultrasound at discharge. Secondary endpoints include crossover, hemostasis time, and access site-related complications.
Results
Overall, 657 patients underwent TRA, and 650 patients underwent DRA. Forearm RAO did not differ between groups (0.91% vs 0.31%; P = 0.29). Patent hemostasis was achieved in 94.4% of TRA patients. Crossover rates were higher with DRA (3.5% vs 7.4%; P = 0.002), and median hemostasis time was shorter (180 vs 153 minutes; P < 0.001). Radial artery spasm occurred more with DRA (2.7% vs 5.4%; P = 0.015). Overall bleeding events and vascular complications did not differ between groups.
Conclusions
With the implementation of a rigorous hemostasis protocol, DRA and TRA have equally low RAO rates. DRA is associated with a higher crossover rate but a shorter hemostasis time.

Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 May 2022; epub ahead of print
Aminian A, Sgueglia GA, Wiemer M, Kefer J, ... Tobita K, Saito S
JACC Cardiovasc Interv: 10 May 2022; epub ahead of print | PMID: 35595673
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Abstract

Transcatheter Aortic Valve Replacement With Self-Expanding ACURATE neo2: Postprocedural Hemodynamic and Short-Term Clinical Outcomes.

Buono A, Gorla R, Ielasi A, Costa G, ... Maffeo D, ITAL-neo Investigators
Objectives
The aim of this study was to assess the efficacy and safety of the ACURATE neo2 transcatheter heart valve (THV) in patients with severe aortic valve stenosis.
Background
The first-generation ACURATE neo THV was associated with a non-negligible occurrence of moderate or greater paravalvular aortic regurgitation (AR) following transcatheter aortic valve replacement. To overcome this issue, the ACURATE neo2 iteration, which incorporates a taller outer skirt aimed at reducing the occurrence of paravalvular AR, has recently been developed.
Methods
ITAL-neo was an observational, retrospective, multicenter registry enrolling consecutive patients with severe aortic valve stenosis, treated with first- and second-generation ACURATE neo THVs, via transfemoral and trans-subclavian access, in 13 Italian centers. One-to-one propensity score matching was applied to account for baseline characteristics unbalance. The primary endpoint was the occurrence of moderate or greater paravalvular AR on predischarge echocardiographic assessment. Secondary endpoints included postprocedural technical success and 90-day device success and safety.
Results
Among 900 patients included in the registry, 220 received the ACURATE neo2 THV, whereas 680 were treated with the first-generation device. Four hundred ten patients were compared after 1:1 propensity score matching. The ACURATE neo2 THV was associated with a 3-fold lower frequency of postprocedural moderate or greater paravalvular AR (11.2% vs 3.5%; P < 0.001). No other hemodynamic differences were observed. Postprocedural technical success was similar between the 2 cohorts. Fewer adverse events were observed in patients treated with the ACURATE neo2 at 90 days.
Conclusions
Transfemoral transcatheter aortic valve replacement using the ACURATE neo2 was associated with a significant lower frequency of moderate or greater paravalvular AR compared with the earlier generation ACURATE neo device, with encouraging short-term safety and efficacy.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 May 2022; epub ahead of print
Buono A, Gorla R, Ielasi A, Costa G, ... Maffeo D, ITAL-neo Investigators
JACC Cardiovasc Interv: 10 May 2022; epub ahead of print | PMID: 35595675
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Abstract

Predicted and Observed Mortality at 10-Years in Patients With Bifurcation Lesions in the SYNTAX Trial.

Ninomiya K, Serruys PW, Garg S, Gao C, ... Onuma Y, SYNTAX Extended Survival Investigators
Objectives
The aim of this study was to investigate the impact of bifurcation lesions on individual predicted and observed all-cause 10-year mortality in the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trial.
Background
Percutaneous coronary intervention (PCI) of bifurcation lesions is associated with higher rates of adverse events, and currently it is unclear whether PCI or coronary artery bypass grafting (CABG) is the safer treatment for these patients at very long term follow-up.
Methods
In the SYNTAXES (SYNTAX Extended Survival) study, 10-year observed and individual predicted mortality derived from the SYNTAX score 2020 (SS-2020) was compared between patients with ≥1 bifurcation (n = 1,300) and those with no bifurcations (n = 487).
Results
Among patients treated with PCI, patients with >1 bifurcation lesion compared with those without bifurcation lesions had a significantly higher risk for all-cause death (19.8% vs 30.1%; HR: 1.55; 95% CI: 1.12 to 2.14; P = 0.007), whereas following CABG, mortality was similar in patients with and those without bifurcation lesions (23.3% vs 23.0%; HR: 0.81; 95% CI: 0.59 to 1.12; P = 0.207; Pinteraction = 0.006). In PCI patients, a 2-stent vs a 1-stent technique was associated with higher mortality (33.3% vs 25.9%; HR: 1.51; 95% CI: 1.06 to 2.14; P = 0.021). According to the SS-2020, among those with ≥1 bifurcation, there was equipoise for all-cause mortality between PCI and CABG in 2 quartiles of the population, whereas CABG was superior to PCI in the 2 remaining quartiles.
Conclusions
Bifurcation lesions require special attention from the heart team, considering the higher 10-year all-cause mortality associated with PCI. Careful evaluation of bifurcation lesion complexity and calculation of individualized 10-year prognosis using the SS-2020 may therefore be helpful in decision making. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES], NCT03417050; Taxus Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX], NCT00114972).

Copyright © 2022 American College of Cardiology Foundation. All rights reserved.

JACC Cardiovasc Interv: 10 May 2022; epub ahead of print
Ninomiya K, Serruys PW, Garg S, Gao C, ... Onuma Y, SYNTAX Extended Survival Investigators
JACC Cardiovasc Interv: 10 May 2022; epub ahead of print | PMID: 35595676
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Abstract

Catheterization in Adults With Congenital Heart Disease: A Primer for the Noncongenital Proceduralist.

Miranda WR, Aboulhosn JA, Hagler DJ
Currently in the United States, more than 1 million adults have congenital heart disease. Therefore, it will be inevitable for providers performing cardiac catheterization to be faced with adults with repaired congenital heart abnormalities. Moreover, a meticulous approach to every cardiac catheterization procedure is mandatory to avoid missing unrecognized congenital lesions presenting in adulthood. The authors provide a primer for cardiac catheterization procedures in adults with congenital heart disease, reviewing key procedural components: flow calculation, detection of shunts according to different lesions, and, when indicated, ventricular angiography and coronary angiography.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 09 May 2022; 15:907-921
Miranda WR, Aboulhosn JA, Hagler DJ
JACC Cardiovasc Interv: 09 May 2022; 15:907-921 | PMID: 35512915
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Abstract

Long-Term Outcomes of Patients With Elevated Mitral Valve Pressure Gradient After Mitral Valve Edge-to-Edge Repair.

Koell B, Ludwig S, Weimann J, Waldschmidt L, ... Lubos E, Kalbacher D
Objectives
The aim of this study was to investigate the adverse impact of elevated postprocedural mitral valve pressure gradient (MPG) on outcome in a real-world population of patients with severe mitral regurgitation (MR) who underwent transcatheter mitral valve edge-to-edge repair (TEER).
Background
TEER has become a routine treatment alternative for patients with severe MR at high surgical risk. The consequences of elevated MPG after TEER have been subject to controversial debates.
Methods
All consecutive patients undergoing TEER for either severe degenerative MR (DMR) or functional MR (FMR) at a high-volume center between September 2008 and January 2020 were prospectively included and followed periodically. Postprocedural MPG by discharge transthoracic echocardiography was considered elevated at ≥5 mm Hg. The primary combined endpoint was death or heart failure rehospitalization after 5 years.
Results
A total of 713 patients undergoing TEER (DMR, n = 265; FMR, n = 445) were included. Elevated postprocedural MPG was present in 37.0% of those with DMR (n = 98) and 22.0% of those with FMR (n = 98). In contrast to patients with FMR, 6-minute walk distance did not improve in patients with DMR with elevated MPG. Kaplan-Meier analyses did not demonstrate significant differences for the primary endpoint in patients with DMR (low vs elevated MPG, 67.3% vs 74.4%; P = 0.06) and those with FMR (78.6% vs 74.8%; P = 0.54). After adjustment, elevated MPG was an independent predictor of the primary endpoint in patients with DMR (HR: 1.59; 95% CI: 1.03-2.45; P = 0.034) but not in those with FMR (HR: 0.87; 95% CI: 0.63-1.22; P = 0.43).
Conclusions
Elevated postprocedural MPG is an independent predictor of adverse clinical and functional outcomes in patients with DMR but not in those with FMR.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 09 May 2022; 15:922-934
Koell B, Ludwig S, Weimann J, Waldschmidt L, ... Lubos E, Kalbacher D
JACC Cardiovasc Interv: 09 May 2022; 15:922-934 | PMID: 35512916
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Abstract

Prognostic Value of Increased Mitral Valve Gradient After Transcatheter Edge-to-Edge Repair for Primary Mitral Regurgitation.

Yoon SH, Makar M, Kar S, Chakravarty T, ... Bax JJ, Makkar RR
Objectives
This study sought to evaluate the prognostic value of an increased mean mitral valve pressure gradient (MVG) in patients with primary mitral regurgitation (MR) after transcatheter edge-to-edge repair (TEER).
Background
Conflicting data exist regarding impact of increased mean MVG on outcomes after TEER.
Methods
This study included 419 patients with primary MR (mean age 80.6 ± 10.4 years; 40.6% female) who underwent TEER. Patients were divided into quartiles (Qs) based on discharge echocardiographic mean MVG. Primary outcome was the composite endpoint of all-cause mortality and heart failure hospitalization. Secondary outcomes included all-cause mortality and the secondary composite endpoint of all-cause mortality, heart failure hospitalization, and mitral valve reintervention.
Results
The median number of MitraClips used was 2 per patient. MR reduction ≤moderate was achieved in 407 (97.1%) patients. Mean MVG was 1.9 ± 0.3 mm Hg, 3.0 ± 0.1 mm Hg, 4.0 ± 0.1 mm Hg, and 6.0 ± 1.2 mm Hg in Q1, Q2, Q3, and Q4, respectively. There was no significant differences across quartiles in the primary outcome (15.4%, 19.6%, 22.0%, and 21.9% in Q1-Q4, respectively; P = 0.63), all-cause mortality (15.9% vs 18.6% vs 19.4% vs 17.1%, respectively; P = 0.91), and the secondary composite endpoint at 2 years (33.3% vs 29.5% vs 22.0% vs 31.6%, respectively; P = 0.37). After multivariate adjustment for baseline clinical and procedural variables, the mean MVG in Q4 compared with Q1 to Q3 was not independently associated with the primary outcome (HR: 1.22; 95% CI: 0.82-1.83; P = 0.33), all-cause mortality, and the secondary composite endpoint.
Conclusions
Increased mean MVG was not independently associated with adverse events after TEER in patients with primary MR.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 09 May 2022; 15:935-945
Yoon SH, Makar M, Kar S, Chakravarty T, ... Bax JJ, Makkar RR
JACC Cardiovasc Interv: 09 May 2022; 15:935-945 | PMID: 35512917
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Abstract

Patient-Level Analysis of Watchman Left Atrial Appendage Occlusion in Practice Versus Clinical Trials.

Friedman DJ, Du C, Wang Y, Agarwal V, ... Curtis JP, Freeman JV
Objectives
The aim of this study was to compare outcomes among patients from the PROTECT-AF (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation) and PREVAIL (Evaluation of the WATCHMAN Left Atrial Appendage [LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) left atrial appendage occlusion (LAAO) trials with matched patients from the National Cardiovascular Data Registry LAAO Registry using patient-level data.
Background
Patients undergoing LAAO in clinical practice generally have more comorbidities than trial participants.
Methods
Propensity-matched analyses, with up to 3 registry patients matched to each trial patient, were performed using Cox proportional hazards and Fine-Gray models.
Results
A total of 1,904 registry patients were matched to 667 trial LAAO patients; 1,010 registry patients were matched to 348 warfarin patients. Compared with registry patients, trial LAAO patients experienced more pericardial effusion requiring intervention (3.8% vs 0.6%, P < 0.001), periprocedural ischemic stroke (0.9% vs 0.2%, P = 0.005), and failed device implantation (7.5% vs 3.6%, P < 0.001). The 425-day risk of ischemic stroke in trial LAAO patients was higher than in registry patients (2.70% vs 1.21%; HR: 1.951; P = 0.03); warfarin patients had comparable rates of ischemic stroke compared with registry patients (1.15% vs 1.29%; HR: 0.728; P = 0.57). Hemorrhagic stroke risk was similar among trial LAAO and registry patients (P = 0.88). Hemorrhagic stroke risk was greater among warfarin patients versus registry patients (1.44% vs 0.20%; HR: 5.871, P = 0.03). Mortality was lower in trial LAAO patients than in registry patients (2.92% vs 6.23%; HR: 0.477; P = 0.004), a difference attributable to noncardiovascular deaths. Mortality was similar (P = 0.44) among trial warfarin (4.48%) and registry (5.86%) patients.
Conclusion
In clinical practice, patients who meet trial criteria and undergo LAAO experience a lower risk of ischemic stroke, a similar risk of hemorrhagic stroke, and a higher risk of death after implant versus LAAO trial patients. (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation [PROTECT-AF], NCT00129545; Evaluation of the WATCHMAN Left Atrial Appendage [LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy [PREVAIL], NCT01182441).

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 09 May 2022; 15:950-961
Friedman DJ, Du C, Wang Y, Agarwal V, ... Curtis JP, Freeman JV
JACC Cardiovasc Interv: 09 May 2022; 15:950-961 | PMID: 35512918
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Abstract

Transcaval Versus Transaxillary TAVR in Contemporary Practice: A Propensity-Weighted Analysis.

Lederman RJ, Babaliaros VC, Lisko JC, Rogers T, ... Binongo JN, Greenbaum AB
Objectives
The aim of this study was to compare transcaval and transaxillary artery access for transcatheter aortic valve replacement (TAVR) at experienced medical centers in contemporary practice.
Background
There are no systematic comparisons of transcaval and transaxillary TAVR access routes.
Methods
Eight experienced centers contributed local data collected for the STS/ACC TVT Registry (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry) between 2017 and 2020. Outcomes after transcaval and axillary/subclavian (transaxillary) access were adjusted for baseline imbalances using doubly robust (inverse propensity weighting plus regression) estimation and compared.
Results
Transcaval access was used in 238 procedures and transaxillary access in 106; for comparison, transfemoral access was used in 7,132 procedures. Risk profiles were higher among patients selected for nonfemoral access but similar among patients requiring transcaval and transaxillary access. Stroke and transient ischemic attack were 5-fold less common after transcaval than transaxillary access (2.5% vs 13.2%; OR: 0.20; 95% CI: 0.06-0.72; P = 0.014) compared with transfemoral access (1.7%). Major and life-threatening bleeding (Valve Academic Research Consortium 3 ≥ type 2) were comparable (10.0% vs 13.2%; OR: 0.66; 95% CI: 0.26-1.66; P = 0.38) compared with transfemoral access (3.5%), as was blood transfusion (19.3% vs 21.7%; OR: 1.07; 95% CI: 0.49-2.33; P = 0.87) compared with transfemoral access (7.1%). Vascular complications, intensive care unit and hospital length of stay, and survival were similar between transcaval and transaxillary access. More patients were discharged directly home and without stroke or transient ischemic attack after transcaval than transaxillary access (87.8% vs 62.3%; OR: 5.19; 95% CI: 2.45-11.0; P < 0.001) compared with transfemoral access (90.3%).
Conclusions
Patients undergoing transcaval TAVR had lower rates of stroke and similar bleeding compared with transaxillary access in a contemporary experience from 8 US centers. Both approaches had more complications than transfemoral access. Transcaval TAVR access may offer an attractive option.

Published by Elsevier Inc.

JACC Cardiovasc Interv: 09 May 2022; 15:965-975
Lederman RJ, Babaliaros VC, Lisko JC, Rogers T, ... Binongo JN, Greenbaum AB
JACC Cardiovasc Interv: 09 May 2022; 15:965-975 | PMID: 35512920
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Abstract

Cardiac Magnetic Resonance to Predict Coronary Artery Compression in Transcatheter Pulmonary Valve Implantation Into Conduits.

Romans RA, Lu JC, Balasubramanian S, Whiteside W, ... Turner ME, Zampi JD
Objectives
The aim of this study was to evaluate the accuracy of cardiac magnetic resonance (CMR) in predicting coronary artery (CA) compression during transcatheter pulmonary valve implantation (TPVi).
Background
TPVi is a widely available option to treat dysfunctional right ventricle (RV)-to-pulmonary artery (PA) conduits, but CA compression is an absolute contraindication. CMR can evaluate coronary anatomy, but its utility in predicting CA compression is not well established.
Methods
After Institutional Review Board approval was obtained, all patients at 9 centers with attempted TPVi in RV-PA conduits and recent CMR (≤12 months) were analyzed. A core laboratory reviewed all CMR studies for the shortest orthogonal distance from a CA to the conduit, the shortest distance from a CA to the most stenotic area of the conduit, and subjective assessment of CA compression risk.
Results
Among 231 patients, TPVi was successful in 198 (86%); in 24 (10%), balloon testing precluded implantation (documented CA compression or high risk). Distance to the RV-PA conduit ≤2.1 mm (area under the curve [AUC]: 0.70) and distance to most stenotic area ≤13.1 mm (AUC: 0.69) predicted CA compression. Subjective assessment had the highest AUC (0.78), with 96% negative predictive value. Both distances and qualitative assessment remained independently associated with CA compression when controlling for abnormal coronary anatomy or degree of conduit calcification.
Conclusions
CMR can help predict the risk for CA compression during TPVi in RV-PA conduits but cannot completely exclude CA compression. CMR may assist in patient selection and counseling families prior to TPVi, although balloon testing remains essential.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 09 May 2022; 15:979-988
Romans RA, Lu JC, Balasubramanian S, Whiteside W, ... Turner ME, Zampi JD
JACC Cardiovasc Interv: 09 May 2022; 15:979-988 | PMID: 35512922
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Abstract

International Hand Function Study Following Distal Radial Access: The RATATOUILLE Study.

Sgueglia GA, Hassan A, Harb S, Ford TJ, ... Kuiper B, Kiemeneij F
Objectives
The study sought to comprehensively evaluate hand function in patients undergoing DRA.
Background
Distal radial access (DRA) has been proposed to improve procedure ergonomics and favor radial artery patency. Although promising data, nothing is known on evolving hand function after DRA.
Methods
Real-world patients undergoing DRA undertook a thorough multimodality assessment of hand function implementing multidomain questionnaires (Disabilities of the Arm, Shoulder and Hand and Levine-Katz), and motor (pinch grip test) and sensory (Semmes-Weinstein monofilaments test) examinations of both hands. All assessments were performed at pre-procedural baseline and planned at 1-, 6-, and 12-month follow-up (FU). Adverse clinical and procedural events were documented too.
Results
Data of 313 patients (220 men, 66 ± 10 years) from 9 international centers were analyzed. The Disabilities of the Arm, Shoulder and Hand and the Levine-Katz scores slightly improved from baseline to FU (P = 0.008 and P = 0.029, respectively). Pinch strength mildly improved from baseline to FU (P < 0.001 for both the left and right hands). Similarly, touch pressure threshold appeared to faintly improve in both the left and right hands (P < 0.012 for all the sites). For both motor and sensory function tests, comparable findings were found for the DRA hand and the contralateral one, with no significant differences between them. Repeated assessment of all tests over all FU time points similarly showed lack of worsening hand function. Access-related adverse events included 19 harmless bleedings and 3 forearm radial artery and 3 distal radial artery occlusions. None affected hand function at FU.
Conclusions
In a systematic multidimensional assessment, DRA was not associated with hand function impairment. Moreover, DRA emerges as a safe alternative vascular access.

Copyright © 2022 American College of Cardiology Foundation. All rights reserved.

JACC Cardiovasc Interv: 09 May 2022; epub ahead of print
Sgueglia GA, Hassan A, Harb S, Ford TJ, ... Kuiper B, Kiemeneij F
JACC Cardiovasc Interv: 09 May 2022; epub ahead of print | PMID: 35595672
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Abstract

Dual Antiplatelet Therapy Discontinuation, Platelet Reactivity, and Adverse Outcomes After Successful Percutaneous Coronary Intervention.

Redfors B, Kirtane AJ, Liu M, Musikantow DR, ... Mehran R, Stone GW
Objectives
The purpose of this study was to assess the extent to which the association between premature dual antiplatelet therapy (DAPT) discontinuation and excess risk of thrombotic events varies according to the reason and timing of DAPT discontinuation and whether high on-treatment platelet reactivity (HPR) influences the risk of thrombotic events after premature DAPT discontinuation.
Background
DAPT after percutaneous coronary intervention (PCI) suppresses platelet reactivity, and HPR on clopidogrel after PCI is associated with an increased risk of thrombotic events.
Methods
ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective, multicenter registry of 8,582 patients successfully treated with coronary drug-eluting stents that assessed HPR on clopidogrel. For patients who discontinued aspirin or clopidogrel at any time during the study, the reasons for discontinuation were systematically categorized.
Results
Planned DAPT discontinuation occurred within 2 years in 3,203 (37.3%) patients. One thousand four hundred eighteen (16.5%) patients discontinued DAPT for unplanned reasons, including surgery or trauma (n = 768 [8.9%]), patient nonadherence (n = 321 [3.7%]), bleeding complications (n = 264 [3.1%]), and drug allergy or hypersensitivity (n = 113 [1.3%]). Unplanned but not planned DAPT discontinuation was associated with an increased risk of a major adverse cardiac event (MACE, defined as the composite of cardiac death, myocardial infarction, or stent thrombosis); with highest risk within 3 months after PCI (adjusted HR: 7.65, 95% CI: 2.77-21.10 vs adjusted HR: 2.47, 95% CI: 1.70-3.58 for unplanned DAPT discontinuation ≥3 weeks after PCI). MACE risk after DAPT discontinuation was not moderated by HPR (Pinteraction = 0.91).
Conclusions
In this large-scale all-comers registry, premature DAPT discontinuation for unplanned reasons occurred in approximately 1 of 6 patients after DES implantation and was associated with a markedly increased risk of MACEs. (Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents [ADAPT-DES]; NCT00638794).

Copyright © 2022. Published by Elsevier Inc.

JACC Cardiovasc Interv: 25 Apr 2022; 15:797-806
Redfors B, Kirtane AJ, Liu M, Musikantow DR, ... Mehran R, Stone GW
JACC Cardiovasc Interv: 25 Apr 2022; 15:797-806 | PMID: 35450679
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Abstract

Radial Hemostasis Is Facilitated With a Potassium Ferrate Hemostatic Patch: The STAT2 Trial.

Safirstein JG, Tehrani DM, Schussler JM, Reid N, ... Yang T, Seto AH
Objectives
The aim of this trial was to test whether the potassium ferrate hemostatic patch (PFHP) as an adjunct to the TR Band (TRB) facilitated an early deflation protocol.
Background
Shorter TRB compression times may reduce the rate of radial artery occlusion (RAO) and reduce observation time after transradial access.
Methods
A total of 443 patients were randomized to the TRB or PFHP + TRB, with complete TRB deflation attempted 60 minutes postprocedure. The primary outcome was the time to successful full deflation of the TRB without bleeding, with secondary outcomes of time to discharge and complications including hematoma, RAO, or bleeding requiring intervention beyond TRB reinflation.
Results
Time to complete TRB deflation was 66 ± 14 minutes with the PFHP vs 113 ± 56 minutes for the TRB alone (P < 0.001). Minor rebleeding requiring TRB reinflation was much more frequent without the PFHP (0% vs 67.7%; P < 0.001) with 2.3 ± 1.3 additional reinflation and deflation attempts needed for hemostasis. Hematomas developed in 4.0% of the PFHP group and 6.8% of the TRB group (P = 0.20). RAO was rare (<1%), although 41% of patients received <5,000 U heparin. Among percutaneous coronary intervention patients, time to TRB deflation (68 ± 15 minutes vs 138 ± 62 minutes; P < 0.001) and composite complications (10.0% vs 24.2%; P = 0.04) were reduced with the PFHP.
Conclusions
Compared with the TRB alone, the PFHP facilitated early 60-minute TRB deflation following transradial catheterization, with a numeric reduction in vascular complications. RAO occurs rarely with early deflation regardless of heparin dose. (Comparing TR Band to StatSeal in Conjunction With TR Band II [StatSeal II]; NCT04046952).

Published by Elsevier Inc.

JACC Cardiovasc Interv: 25 Apr 2022; 15:810-819
Safirstein JG, Tehrani DM, Schussler JM, Reid N, ... Yang T, Seto AH
JACC Cardiovasc Interv: 25 Apr 2022; 15:810-819 | PMID: 35450681
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Abstract

Femoral or Radial Approach in Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial.

Gorgulu S, Kalay N, Norgaz T, Kocas C, Goktekin O, Brilakis ES
Objectives
The aim of this study was to compare transradial access (TRA) with transfemoral access (TFA) for chronic total occlusion (CTO) percutaneous coronary intervention (PCI).
Background
TRA reduces the risk for vascular access complications but may make complex PCI, such as CTO PCI, more challenging.
Methods
FORT CTO (Femoral or Radial Approach in the Treatment of Coronary Chronic Total Occlusion) (NCT03265769) was a prospective, noninferiority, randomized controlled study of TRA vs TFA for CTO PCI. The primary study endpoint was procedural success, defined as technical success without any in-hospital major adverse cardiovascular events. The secondary study endpoint was major access-site complications.
Results
Between 2017 and 2021, 610 of 800 patients referred for CTO PCI at 4 centers were randomized to TRA (n = 305) or TFA (n = 305). Mean J-CTO (Multicenter CTO Registry in Japan) (2.1 ± 0.1 vs 2.2 ± 0.1; P = 0.279), PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) (1.3 ± 0.9 vs 1.1 ± 1.0; P = 0.058) and PROGRESS CTO complication (2.4 ± 1.8 vs 2.3 ± 1.8; P = 0.561) scores and use of the retrograde approach (11% vs 14%; P = 0.342) were similar in the TRA and TFA groups. TRA was noninferior to TFA for procedural success (84% vs 86%; P = 0.563) but had fewer access-site complications (2.0% vs 5.6%; P = 0.019). There was no difference between TFA and TRA in procedural duration, contrast volume, or radiation dose.
Conclusions
TRA was noninferior to TFA for CTO PCI but had fewer access-site complications.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 25 Apr 2022; 15:823-830
Gorgulu S, Kalay N, Norgaz T, Kocas C, Goktekin O, Brilakis ES
JACC Cardiovasc Interv: 25 Apr 2022; 15:823-830 | PMID: 35450683
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Abstract

Retrograde Chronic Total Occlusion Percutaneous Coronary Interventions: Predictors of Procedural Success From the ERCTO Registry.

Myat A, Galassi AR, Werner GS, Mashayekhi K, ... di Mario C, Hildick-Smith D
Objectives
The aim of this study was to identify independent predictors of procedural success after retrograde chronic total occlusion (CTO) percutaneous coronary intervention (PCI).
Background
Retrograde CTO PCI is an established technique, but predictors of success remain poorly understood.
Methods
A multivariable logistic regression model was used to analyze potentially important demographic, clinical, anatomical, and technical aspects of retrograde CTO PCI cases uploaded to the multicenter European CTO (ERCTO) Club Registry.
Results
In calendar years 2018 and 2019, 2,364 retrograde CTO PCI cases constituted the primary analysis cohort. A primary retrograde strategy was used in 1,953 cases (82.6%), and an initial antegrade approach was converted to retrograde in 411 cases (17.4%). Procedural success was achieved in 1,820 cases (77.0%) and was more likely to occur after a primary retrograde attempt versus conversion from an initial antegrade approach (80.9% vs 58.4%; P < 0.0001). After multivariable analysis, an absence of lesion calcification (OR: 1.86; 95% CI: 1.37-2.51; P < 0.0001), a higher degree of distal vessel opacification (OR: 2.47; 95% CI: 1.72-3.55; P < 0.0001), little or no proximal target vessel tortuosity (OR: 1.84; 95% CI: 1.28-2.64; P = 0.001), Werner collateral connection CC1 (OR: 4.87; 95% CI: 2.90-8.19; P < 0.0001) or CC2 (OR: 5.33; 95% CI: 3.02-9.42; P < 0.0001), and the top tertile of operator volume (>120 cases over 2 years) (OR: 1.88; 95% CI: 1.26-2.79; P = 0.002) were associated with the greatest chance of achieving angiographic success.
Conclusions
Less calcification with good distal vessel opacification, little or absent proximal vessel tortuosity, and visible collateral connections, along with high-volume operator status, were all independently predictive of angiographically successful retrograde CTO PCI.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 25 Apr 2022; 15:834-842
Myat A, Galassi AR, Werner GS, Mashayekhi K, ... di Mario C, Hildick-Smith D
JACC Cardiovasc Interv: 25 Apr 2022; 15:834-842 | PMID: 35450685
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Abstract

Percutaneous Coronary Intervention Volume and Cardiac Surgery Availability Effect on Acute Coronary Syndrome-Related Cardiogenic Shock.

Noaman S, Vogrin S, Dinh D, Lefkovits J, ... Chan W, VCOR Investigators
Objectives
This study sought to assess the association between cardiac surgery availability and percutaneous coronary intervention (PCI) volume with clinical outcomes of cardiogenic shock (CS) complicating acute coronary syndrome (ACS).
Background
CS remains a grave complication of ACS with high mortality rates despite timely reperfusion and improved heart failure therapies.
Methods
The study analyzed data from consecutive patients with CS complicating ACS who underwent PCI and were prospectively enrolled in the VCOR (Victorian Cardiac Outcomes Registry) from 26 hospitals in Victoria. We compared patients treated at cardiac surgical centers (CSCs) versus non-CSCs as well as the annual CS PCI volume (stratified into tiers of <10, 10-25, and >25 cases) for in-hospital major adverse cardiac and cerebrovascular events (MACCE) and long-term mortality.
Results
Of 1,179 patients with CS, the mean age of patients was 65 years; males comprised 74%, and 22% had diabetes mellitus. Cardiac arrest occurred in 38% of patients, while 90% presented with ST-segment elevation myocardial infarction and 26% received intra-aortic balloon pump support. Overall, in-hospital and long-term mortality were 42% and 51%, respectively. There was no difference among patients treated non-CSCs compared with a CSCs for in-hospital MACCE and mortality (both P > 0.05). Similarly, there was no association between tiers of annual CS PCI volume with in-hospital MACCE and mortality (both P > 0.05).
Conclusions
Comparable short- and long-term mortality rates among patients with ACS complicated by CS treated by PCI irrespective of cardiac surgery availability and CS PCI volume support the emergent treatment of these gravely ill patients at their presenting PCI-capable hospital.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 25 Apr 2022; 15:876-886
Noaman S, Vogrin S, Dinh D, Lefkovits J, ... Chan W, VCOR Investigators
JACC Cardiovasc Interv: 25 Apr 2022; 15:876-886 | PMID: 35450687
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Abstract

Differential Prognostic Value of Revascularization for Coronary Stenosis With Intermediate FFR by Coronary Flow Reserve.

Kim J, Shin D, Lee JM, Lee SH, ... van de Hoef TP, ILIAS Registry Investigators
Objectives
The authors sought to evaluate comparative prognosis between deferred versus performed percutaneous coronary intervention (PCI) according to coronary flow reserve (CFR) values of patients with intermediate fractional flow reserve (FFR).
Background
For coronary stenosis with intermediate FFR, the prognostic value of PCI remains controversial. The prognostic impact of PCI may be different according to CFR in patients with intermediate FFR.
Methods
From the ILIAS Registry (Inclusive Invasive Physiological Assessment in Angina Syndromes Registry, N = 2,322), 400 patients (412 vessels) with intermediate FFR (0.75-0.80) were selected. Patients were stratified into preserved CFR (>2.0, n = 253) and depressed CFR (≤2.0, n = 147) cohorts. Per-vessel clinical outcomes during 5 years of follow-up were compared between deferred versus performed PCI groups in both cohorts. The primary outcome was target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization.
Results
Among the study population, PCI was deferred for 210 patients (219 vessels, 53.2%) (deferred group) and performed for 190 patients (193 vessels, 46.8%) (performed group). The risk of TVF was comparable between the deferred and performed groups (12.8% vs 14.2%; adjusted HR: 1.403; 95% CI: 0.584-3.369; P = 0.448). When stratified by CFR, PCI was performed in 39.1% (100/261 vessels) of the preserved CFR cohort and 61.9% (93/151 vessels) of the depressed CFR cohort. Within the preserved CFR cohort, the risk of TVF did not differ significantly between the deferred and performed groups (11.0% vs 13.9%; adjusted HR: 0.770; 95% CI: 0.262-2.266; P = 0.635). However, in the depressed CFR cohort, the deferred group had a significantly higher risk of TVF than the performed group (17.2% vs 14.2%; adjusted HR: 4.932; 95% CI: 1.312-18.53; P = 0.018). A significant interaction was observed between CFR and the treatment decision (interaction P = 0.049). Results were consistent after inverse probability weighting adjustment.
Conclusions
In patients with intermediate FFR of 0.75 to 0.80, the prognostic value of PCI differed according to CFR, with a significant interaction. PCI was associated with a lower risk of TVF compared with the deferral strategy when CFR was depressed (≤2.0), but there was no difference when CFR was preserved (>2.0). CFR could be used as an additional risk stratification tool to determine treatment strategies in patients with intermediate FFR. (Inclusive Invasive Physiological Assessment in Angina Syndromes Registry [ILIAS Registry]; NCT04485234).

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 20 Apr 2022; epub ahead of print
Kim J, Shin D, Lee JM, Lee SH, ... van de Hoef TP, ILIAS Registry Investigators
JACC Cardiovasc Interv: 20 Apr 2022; epub ahead of print | PMID: 35490124
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Abstract

Minimum Core Data Elements for Evaluation of TAVR: A Scientific Statement by PASSION CV, HVC, and TVT Registry.

Simonato M, Vemulapalli S, Ben-Yehuda O, Wu C, ... Carroll J, Krucoff M
Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, as well as clinical research and real-world implementation through appropriate use criteria. The essential minimum core dataset for these purposes has not previously been defined but is necessary to promote efficient, reusable real-world data collection supporting quality, regulatory, and clinical applications. The authors performed a systematic review of the published research for high-impact TAVR studies and U.S. multicenter, multidevice registries. Two expert task forces, one from the Predictable and Sustainable Implementation of National Cardiovascular Registries/Heart Valve Collaboratory and another from The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry convened separately and then met to reconcile a final list of essential data elements. From 276 unique data elements considered, unanimous consensus agreement was achieved on 132 \"core\" data elements, with the most common reasons for exclusion from the minimum core dataset being burden or difficulty in accurate assessment (36.9%), duplicative information (33.3%), and low likelihood of affecting outcomes (10.7%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence for regulatory submissions, safety surveillance, best practice, and hospital quality assessments.

Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Apr 2022; 15:685-697
Simonato M, Vemulapalli S, Ben-Yehuda O, Wu C, ... Carroll J, Krucoff M
JACC Cardiovasc Interv: 11 Apr 2022; 15:685-697 | PMID: 35367168
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Abstract

5-Year Follow-Up From the PARTNER 2 Aortic Valve-in-Valve Registry for Degenerated Aortic Surgical Bioprostheses.

Hahn RT, Webb J, Pibarot P, Ternacle J, ... Leon MB, Mack M
Objectives
The aim of this study was to report the outcomes of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) at 5 years.
Background
TAVR for degenerated surgical bioprostheses in patients at high risk for reoperative surgery is an important treatment option that may delay or obviate the need for surgical intervention; however, long-term outcomes of this procedure are unknown.
Methods
The PARTNER (Placement of Aortic Transcatheter Valves) 2 ViV and continued access registries prospectively enrolled patients with failed surgical bioprostheses at high risk for reoperation. Five-year clinical and echocardiographic follow-up data were obtained in 95.9% of patients.
Results
In 365 (96 registry and 269 continued access) patients, the mean age was 78.9 ± 10.2 years, the mean Society of Thoracic Surgeons predicted risk of surgical mortality score was 9.1 ± 4.7%, and New York Heart Association functional class was III or IV in 90.4%. At 5 years, the Kaplan-Meier rates of all-cause mortality and any stroke were 50.6% and 10.5%, respectively. Using Valve Academic Research Consortium 3 definitions, the incidence of structural valve deterioration, related hemodynamic valve deterioration, or bioprosthetic valve failure at 5 years was 6.6%. Aortic valve re-replacement was performed in 6.3% (n = 14), the majority of which was due to stenosis (n = 6) and combined aortic insufficiency/paravalvular regurgitation (n = 3). The mean gradient, Doppler velocity index, paravalvular regurgitation, and quality of life measured by Kansas City Cardiomyopathy Questionnaire scores in survivors remained stable from 30 days postprocedure through 5 years.
Conclusions
At the 5-year follow-up, TAVR for bioprosthetic aortic valve failure in high surgical risk patients was associated with sustained improvement in clinical and echocardiographic outcomes.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Apr 2022; 15:698-708
Hahn RT, Webb J, Pibarot P, Ternacle J, ... Leon MB, Mack M
JACC Cardiovasc Interv: 11 Apr 2022; 15:698-708 | PMID: 35393102
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Abstract

Risk of Coronary Obstruction During Redo-TAVR in Patients With Bicuspid Versus Tricuspid Aortic Valve Stenosis.

Chen F, Xiong T, Li Y, Wang X, ... Feng Y, Chen M
Objectives
The aim of this study was to investigate the risk of coronary obstruction during redo-transcatheter aortic valve replacement (TAVR) within a previously implanted self-expanding valve in bicuspid aortic valve (BAV) versus tricuspid aortic valve (TAV) stenosis.
Background
The prevalence of BAV in TAVR patients is expected to increase as the indication expands; however, no study has investigated the risk of coronary obstruction for future redo-TAVR in these patients.
Methods
Computed tomography (CT) simulation analysis was performed in 86 type 0 BAV, 70 type 1 BAV, and 132 TAV patients who underwent TAVR with 1 VenusA-Valve (Venus Medtech) between January 2014 and December 2019.
Results
CT-identified risk of coronary obstruction during redo-TAVR was observed in 36.1% of patients for the left coronary ostium (LCO) and 27.8% of patients for the right coronary ostium (RCO); however, the incidences were significantly lower in the type 0 BAV group than in the type 1 BAV or TAV group (for LCO: OR: 1.00 [reference] vs OR: 2.49; 95% CI: 1.24-5.01 vs OR: 2.60; 95% CI: 1.40-4.81; for RCO: OR: 1.00 [reference] vs OR: 2.14; 95% CI: 1.02-4.48 vs OR: 1.97; 95% CI: 1.02-3.80). The leaflet laceration technique may be unfeasible to improve coronary flow in 61.5% of the threatened LCOs and 58.8% of the threatened RCOs during redo-TAVR. The percentages were significantly or numerically lower in the type 0 BAV group than other groups (for LCO: 26.3% vs 62.1% vs 73.2%; P overall = 0.001; for RCO: 43.8% vs 65.2% vs 61.0%; P overall = 0.374).
Conclusions
Differences in anatomical features may impact the feasibility of future redo-TAVR. Type 0 BAV anatomy was associated with the lower incidence of CT-identified risk of coronary obstruction during redo-TAVR, and the leaflet laceration technique may be more feasible to ensure coronary flow in this population.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Apr 2022; 15:712-724
Chen F, Xiong T, Li Y, Wang X, ... Feng Y, Chen M
JACC Cardiovasc Interv: 11 Apr 2022; 15:712-724 | PMID: 35393104
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Impact:
Abstract

Functional Status After Transcatheter and Surgical Aortic Valve Replacement: 2-Year Analysis From the SURTAVI Trial.

Tuttle MK, Kiaii B, Van Mieghem NM, Laham RJ, ... Li S, Reardon MJ
Objectives
This study sought to evaluate patient-centered metrics in intermediate-surgical-risk aortic stenosis patients enrolled in the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial treated with self-expanding transcatheter aortic valve replacement (TAVR) or surgery.
Background
Studies have shown TAVR to be an alternative to surgery in patients with severe symptomatic aortic stenosis but have focused on \"hard endpoints,\" including all-cause mortality and stroke, rather than on comparative patient-centered metrics, such as functional status and symptom burden.
Methods
The study analyzed functional status (6-minute walk test [6MWT]) and symptom burden (Kansas City Cardiomyopathy Questionnaire) in 1,492 patients from the SURTAVI trial at baseline, 30 days, 1 year, and 2 years. Patients were categorized by baseline functional status into tertiles of slow, medium, and fast walkers.
Results
Patients with lowest capacity baseline functional status were commonly women, had higher Society of Thoracic Surgeons scores, and had more New York Heart Association functional class III or IV symptoms; reduced baseline functional status was associated with higher aortic valve- and heart failure-related hospitalization at 2 years. There was greater improvement in 6MWT distance in TAVR compared with surgery patients at 30 days (P < 0.001) and 1 year (P = 0.012), but at 2 years, both groups had similar improvement (P = 0.091). The percentage of patients with large improvement in 6MWT was greatest in patients categorized as slow walkers and lowest in fast walkers. Symptom burden improved after TAVR at 30 days and after both procedures at 1 and 2 years.
Conclusions
In this substudy of patients from the SURTAVI trial, patients receiving TAVR demonstrated a more rapid improvement in functional status and symptom burden compared with patients undergoing surgery; however, both groups had similar improvements in long-term follow-up. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI]; NCT01586910).

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Apr 2022; 15:728-738
Tuttle MK, Kiaii B, Van Mieghem NM, Laham RJ, ... Li S, Reardon MJ
JACC Cardiovasc Interv: 11 Apr 2022; 15:728-738 | PMID: 35393106
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Abstract

Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States.

Price MJ, Slotwiner D, Du C, Freeman JV, ... Curtis JP, Masoudi FA
Objectives
The aim of this study was to report 1-year clinical outcomes following commercial transcatheter left atrial appendage occlusion (LAAO) in the United States.
Background
The National Cardiovascular Data Registry LAAO Registry was initiated to meet a condition of Medicare coverage and allow the assessment of clinical outcomes. The 1-year rates of thromboembolic events after transcatheter LAAO in such a large cohort of \"real-world\" patients have not been previously reported.
Methods
Patients entered into the National Cardiovascular Data Registry LAAO Registry for a Watchman procedure between January 1, 2016, and December 31, 2018, were included. The primary endpoint was ischemic stroke. Key secondary endpoints included the rate of ischemic stroke or systemic embolism, mortality, and major bleeding. Major bleeding was defined as any bleeding requiring hospitalization, and/or causing a decrease in hemoglobin level > 2g/dL, and/or requiring blood transfusion that was not hemorrhagic stroke. The Kaplan-Meier method was used for 1-year estimates of cumulative event rates.
Results
The study population consisted of 36,681 patients. The mean age was 76.0 ± 8.1 years, the mean CHA2DS2-VASc score was 4.8 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.1. Prior stroke was present in 25.5%, clinically relevant bleeding in 69.5%, and intracranial bleeding in 11.9%. Median follow-up was 374 days (IQR: 212-425 days). The Kaplan-Meier-estimated 1-year rate of ischemic stroke was 1.53% (95% CI: 1.39%-1.69%), the rate of ischemic stroke or systemic embolism was 2.19% (95% CI: 2.01%-2.38%), and the rate of mortality was 8.52% (95% CI: 8.19%-8.87%). The 1-year estimated rate of major bleeding was 6.93% (95% CI: 6.65%-7.21%). Most bleeding events occurred between discharge and 45 days following the procedure.
Conclusions
This study characterizes important outcomes in a national cohort of patients undergoing transcatheter LAAO in the United States. Clinicians and patients can integrate these data in shared decision making when considering this therapy.

Copyright © 2022. Published by Elsevier Inc.

JACC Cardiovasc Interv: 11 Apr 2022; 15:741-750
Price MJ, Slotwiner D, Du C, Freeman JV, ... Curtis JP, Masoudi FA
JACC Cardiovasc Interv: 11 Apr 2022; 15:741-750 | PMID: 35393108
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Abstract

Long-Term Clinical Impact of Contrast-Associated Acute Kidney Injury Following PCI: An ADAPT-DES Substudy.

Mohebi R, Karimi Galougahi K, Garcia JJ, Horst J, ... Stone GW, Ali ZA
Objectives
This study sought to determine correlates and consequences of contrast-associated acute kidney injury (CA-AKI) on clinical outcomes in patients with or without pre-existing chronic kidney disease (CKD).
Background
The incidence and impact of CA-AKI on clinical outcomes during contemporary percutaneous coronary intervention (PCI) are not fully defined.
Methods
The ADAPT-DES (Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents) study was a prospective, multicenter registry of 8,582 patients treated with ≥1 drug-eluting stent(s). CA-AKI was defined as a post-PCI increase in serum creatinine of >0.5 mg/dL or a relative increase of ≥25% compared with pre-PCI. CKD was defined as estimated glomerular filtration rate <60 mL/min/1.73 m2. The primary endpoint was the 2-year rate of net adverse clinical events (NACE): All-cause mortality, myocardial infarction (MI), definite or probable stent thrombosis, or major bleeding.
Results
Of 7287 (85%) patients with evaluable data, 476 (6.5%) developed CA-AKI. In a multivariable model, older age, female sex, Caucasian race, congestive heart failure, diabetes, hypertension, CKD, presentation with ST-segment elevation MI, Killip class II to IV, radial access, intra-aortic balloon pump use, hypotension, and number of stents were independent predictors of CA-AKI. The 2-year NACE rate was higher in patients with CA-AKI (adjusted HR: 1.88; 95% CI: 1.42-2.49), as was each component of NACE (all-cause mortality, HR: 1.77; 95% CI: 1.22-2.55; MI, HR: 1.67; 95% CI: 1.18-2.36; definite/probable stent thrombosis, HR: 1.71; 95% CI: 1.10-2.65; and major bleeding, HR: 1.38; 95% CI: 1.06-1.80). Compared with the CA-AKI-/CKD- group, the CA-AKI+/CKD- (HR: 1.83; 95% CI: 1.33-2.52), CA-AKI-/CKD+ (HR: 1.56; 95% CI: 1.15-2.13), CA-AKI+/CKD+ (HR: 3.29; 95% CI: 1.92-5.67), and maintenance dialysis (HR: 2.67; 95% CI: 1.65-4.31) groups were at higher risk of NACE.
Conclusions
CA-AKI was relatively common after contemporary PCI and was associated with increased 2-year rates of NACE. Patients with pre-existing CKD were at particularly high risk for NACE after CA-AKI.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Apr 2022; 15:753-766
Mohebi R, Karimi Galougahi K, Garcia JJ, Horst J, ... Stone GW, Ali ZA
JACC Cardiovasc Interv: 11 Apr 2022; 15:753-766 | PMID: 35305904
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Abstract

Treatment of Coronary De Novo Lesions by a Sirolimus- or Paclitaxel-Coated Balloon.

Ahmad WAW, Nuruddin AA, Abdul Kader MASK, Ong TK, ... Kutschera M, Scheller B
Objectives
The aim of this randomized controlled trial was to investigate a novel sirolimus-coated balloon (SCB) compared with the best investigated paclitaxel-coated balloon (PCB).
Background
There is increasing clinical evidence for the treatment of coronary de novo disease using drug-coated balloons. However, it is unclear whether paclitaxel remains the drug of choice or if sirolimus is an alternative, in analogy to drug-eluting stents.
Methods
Seventy patients with coronary de novo lesions were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, B. Braun Melsungen; 4 μg/mm2) with a PCB (SeQuent Please, B. Braun Melsungen; 3 μg/mm2). The primary endpoint was angiographic late lumen loss (LLL) at 6 months. Secondary endpoints included major adverse cardiovascular events and individual clinical endpoints such as cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis.
Results
Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment LLL was 0.01 ± 0.33 mm in the PCB group versus 0.10 ± 0.32 mm in the SCB group. The mean difference between SCB and PCB was 0.08 (95% CI: -0.07 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. However, negative LLL was more frequent in the PCB group (60% of lesions vs 32% in the SCB group; P = 0.019). Major adverse cardiovascular events up to 12 months also did not differ between the groups.
Conclusions
This first-in-human comparison of a novel SCB with a crystalline coating showed similar angiographic outcomes in the treatment of coronary de novo disease compared with a clinically proven PCB. However, late luminal enlargement was more frequently observed after PCB treatment. (Treatment of Coronary De-Novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter Malaysia [SCBDNMAL]; NCT04017364).

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Apr 2022; 15:770-779
Ahmad WAW, Nuruddin AA, Abdul Kader MASK, Ong TK, ... Kutschera M, Scheller B
JACC Cardiovasc Interv: 11 Apr 2022; 15:770-779 | PMID: 35305906
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Abstract

Prophylactic Rivaroxaban Therapy for Left Ventricular Thrombus After Anterior ST-Segment Elevation Myocardial Infarction.

Zhang Z, Si D, Zhang Q, Jin L, ... He Y, Zhang W
Objectives
The aim of this study was to investigate the effects of rivaroxaban on left ventricle thromboprophylaxis in patients with anterior ST-segment elevation myocardial infarction (STEMI).
Background
Anterior STEMI is associated with an increased risk of left ventricular thrombus (LVT) formation. The contemporary role of prophylactic rivaroxaban therapy remains unclear.
Methods
We randomly assigned 279 patients with anterior STEMI who had undergone primary percutaneous coronary intervention to receive, in a 1:1 ratio, low-dose rivaroxaban (2.5 mg twice daily for 30 days) and dual antiplatelet therapy (DAPT) or only DAPT. The primary efficacy outcome was the LVT formation within 30 days. Net clinical adverse events were assessed at 30 days and 180 days, including all-cause mortality, LVT, systemic embolism, rehospitalization for cardiovascular events, and bleeding.
Results
The addition of low-dose rivaroxaban to DAPT reduced LVT formation within 30 days compared with only DAPT (0.7% vs 8.6%; HR: 0.08; 95% CI: 0.01-0.62; P = 0.015; P < 0.001 for superiority). Net clinical adverse events were lower within 30 days in the rivaroxaban group versus those in the only DAPT group and remained relatively low throughout the follow-up period. There were no significant differences in bleeding events between the 2 groups in 30 days and 180 days. However, 1 case of intracranial hemorrhage (major bleeding) occurred in the rivaroxaban group within 30 days.
Conclusions
Our results supported that the short-duration addition of low-dose rivaroxaban to DAPT could prevent LVT formation in patients with anterior STEMI following primary percutaneous coronary intervention. A larger multiple-institution study is necessary to determine the generalizability.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 23 Mar 2022; epub ahead of print
Zhang Z, Si D, Zhang Q, Jin L, ... He Y, Zhang W
JACC Cardiovasc Interv: 23 Mar 2022; epub ahead of print | PMID: 35367170
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Abstract

EROSION III: A Multicenter RCT of OCT-Guided Reperfusion in STEMI With Early Infarct Artery Patency.

Jia H, Dai J, He L, Xu Y, ... Mintz GS, Yu B
Objectives
The aim of this study was to test whether optical coherence tomographic (OCT) guidance would provide additional useful information beyond that obtained by angiography and lead to a shift in reperfusion strategy and improved clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) with early infarct artery patency.
Background
Angiography is limited in assessing the underlying pathophysiological mechanisms of the culprit lesion.
Methods
EROSION III (Optical Coherence Tomography-Guided Reperfusion in ST-Segment Elevation Myocardial Infarction With Early Infarct Artery Patency) is an open-label, prospective, multicenter, randomized, controlled study approved by the ethics committees of participating centers. Patients with STEMI who had angiographic diameter stenosis ≤ 70% and TIMI (Thrombolysis In Myocardial Infarction) flow grade 3 at presentation or after antegrade blood flow restoration were recruited and randomized to either OCT guidance or angiographic guidance. The primary efficacy endpoint was the rate of stent implantation.
Results
Among 246 randomized patients, 226 (91.9%) constituted the per protocol set (112 with OCT guidance and 114 with angiographic guidance). The median diameter stenosis was 54.0% (IQR: 48.0%-61.0%) in the OCT guidance group and 53.5% (IQR: 43.8%-64.0%) in the angiographic guidance group (P = 0.57) before randomization. Stent implantation was performed in 49 of 112 patients (43.8%) in the OCT group and 67 of 114 patients (58.8%) in the angiographic group (P = 0.024), demonstrating a 15% reduction in stent implantation with OCT guidance. In patients treated with stent implantation, OCT guidance was associated with a favorable result with lower residual angiographic diameter stenosis (8.7% ± 3.7% vs 11.8% ± 4.6% in the angiographic guidance group; P < 0.001). Two patients (1 cardiac death, 1 stable angina) met the primary safety endpoint in the OCT guidance group, as did 3 patients (3 cardiac deaths) in the angiographic guidance group (1.8% vs 2.6%; P = 0.67). Reinfarction was not observed in either group. At 1 year, the rates of predefined cardiocerebrovascular events were comparable between the groups (11.6% after OCT guidance vs 9.6% after angiographic guidance; P = 0.66).
Conclusions
In patients with STEMI with early infarct artery patency, OCT guidance compared with angiographic guidance of reperfusion was associated with less stent implantation during primary percutaneous coronary intervention. These favorable results indicate the value of OCT imaging in optimizing the reperfusion strategy of patients with STEMI. (EROSION III: OCT- vs Angio-Based Reperfusion Strategy for STEMI; NCT03571269).

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 23 Mar 2022; epub ahead of print
Jia H, Dai J, He L, Xu Y, ... Mintz GS, Yu B
JACC Cardiovasc Interv: 23 Mar 2022; epub ahead of print | PMID: 35367176
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Abstract

Randomized Clinical Trial on Prevention of Radial Occlusion After Transradial Access Using Nitroglycerin: PATENS Trial.

da Silva RL, de Andrade PB, Dangas G, Joaquim RM, ... Feres F, Costa JR
Objectives
The aim of this study was to evaluate whether administration of nitroglycerin at the beginning or end of a transradial approach (TRA) procedure would preserve radial patency.
Background
The TRA is becoming the preferred vascular access route in coronary interventions. Radial artery occlusion (RAO) is the most frequent complication. Routine vasodilator treatment aims to reduce spasm and possibly prevent RAO.
Methods
The authors designed a prospective, multicenter, randomized, double-blind, 2-by-2 factorial, placebo-controlled trial encompassing patients undergoing the TRA. Patients were randomized to either 500 μg nitroglycerin or placebo; each arm was also subrandomized to early (upon sheath insertion) or late (right before sheath removal) nitroglycerin administration to evaluate the superiority of nitroglycerin in the prevention of RAO with 24 hours on Doppler ultrasound.
Results
A total of 2,040 patients were enrolled. RAO occurred in 49 patients (2.4%). Fifteen of these patients (30.6%) showed reestablishment of flow at 30 days. Nitroglycerin, compared with placebo, did not reduce the risk for RAO at either of the 2 time points (early, 2.5% vs 2.3% [P = 0.66]; late, 2.3% vs 2.5% [P = 0.66]). By multivariable analysis, the presence of spasm (OR: 3.53; 95% CI: 1.87-6.65; P < 0.001) and access achieved with more than 1 puncture attempt (OR: 2.58; 95% CI: 1.43-4.66; P = 0.002) were independent predictors of RAO.
Conclusions
The routine use of nitroglycerin was not associated with a reduction in the rate of RAO, regardless of the time of administration (at the beginning or end of the TRA procedure).

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 14 Mar 2022; epub ahead of print
da Silva RL, de Andrade PB, Dangas G, Joaquim RM, ... Feres F, Costa JR
JACC Cardiovasc Interv: 14 Mar 2022; epub ahead of print | PMID: 35331684
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Abstract

Transfemoral Tricuspid Valve Replacement in Patients With Tricuspid Regurgitation: TRISCEND Study 30-Day Results.

Kodali S, Hahn RT, George I, Davidson CJ, ... Makkar R, TRISCEND Investigators
Objectives
The TRISCEND study (Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy after Replacement of Tricuspid Valve with Transcatheter Device) is evaluating the safety and performance of transfemoral transcatheter tricuspid valve replacement in patients with clinically significant tricuspid regurgitation (TR) and elevated surgical risk.
Background
Transcatheter valve replacement could lead to a paradigm shift in treating TR and improving patient quality of life.
Methods
In the prospective, single-arm, multicenter TRISCEND study, patients with symptomatic moderate or greater TR, despite medical therapy, underwent percutaneous transcatheter tricuspid valve replacement with the EVOQUE system. A composite rate of major adverse events, echocardiographic parameters, and clinical, functional, and quality-of-life measures were assessed at 30 days.
Results
Fifty-six patients (mean age of 79.3 years, 76.8% female, 91.1% TR severe or greater, 91.1% atrial fibrillation, and 87.5% New York Heart Association functional class III or IV) were treated. At 30 days, TR was reduced to mild or less in 98%. The composite major adverse events rate was 26.8% at 30 days caused by 1 cardiovascular death in a patient with a failed procedure, 2 reinterventions after device embolization, 1 major access site or vascular complication, and 15 severe bleeds, of which none were life-threatening or fatal. No myocardial infarction, stroke, renal failure, major cardiac structural complications, or device-related pulmonary embolism were observed. New York Heart Association significantly improved to functional class I or II (78.8%; P < 0.001), 6-minute walk distance improved 49.8 m (P < 0.001), and Kansas City Cardiomyopathy Questionnaire score improved 19 points (P < 0.001).
Conclusions
Early experience with the transfemoral EVOQUE system in patients with clinically significant TR demonstrated technical feasibility, acceptable safety, TR reduction, and symptomatic improvement at 30 days. The TRISCEND II randomized trial (NCT04482062) is underway.

Copyright © 2022. Published by Elsevier Inc.

JACC Cardiovasc Interv: 13 Mar 2022; 15:471-480
Kodali S, Hahn RT, George I, Davidson CJ, ... Makkar R, TRISCEND Investigators
JACC Cardiovasc Interv: 13 Mar 2022; 15:471-480 | PMID: 35272771
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Abstract

Transcatheter Tricuspid Valve Replacement With the EVOQUE System: 1-Year Outcomes of a Multicenter, First-in-Human Experience.

Webb JG, Chuang AM, Meier D, von Bardeleben RS, ... Hahn RT, Fam NP
Objectives
The aim of this study was to report the midterm outcomes at 1 year in the expanded first-in-human experience with the transfemoral EVOQUE system (Edwards Lifesciences) for tricuspid regurgitation (TR).
Background
Untreated TR is associated with excess mortality and morbidity. The first-in-human experience with the EVOQUE tricuspid valve replacement system reported favorable 30-day outcomes with no mortality in a compassionate use population.
Methods
Twenty-seven patients with severe TR were treated with the EVOQUE system in a compassionate use experience at 7 centers between May 2019 and July 2020. All patients had clinical right-sided heart failure (HF) and were deemed inoperable and unsuitable for transcatheter edge-to-edge repair by the institutional heart teams. The clinical outcomes collected included all-cause mortality, symptom status, TR severity, HF hospitalization, and major adverse cardiovascular events.
Results
At baseline, all patients (age: 77 ± 8 years, 89% female) were at high surgical risk (mean Society of Thoracic Surgeons score: 8.6% ± 5.5%), with 89% New York Heart Association functional class III/IV. TR was predominantly functional in etiology (19/27, 70%). At 1 year, mortality was 7% (2/27), 70% of patients were New York Heart Association functional class I/II, and 96% and 87% of patients had a TR grade ≤2+ and ≤1+, respectively. Between 30 days and 1 year, 2 patients experienced HF hospitalizations, and 1 patient required a new pacemaker implantation.
Conclusions
In this early, compassionate use experience, the transfemoral transcatheter EVOQUE tricuspid valve replacement system demonstrated durable efficacy, persistent improvement in symptom status, and low rates of mortality and HF hospitalizations at a 1-year follow-up. Further studies are underway to validate its efficacy.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Mar 2022; 15:481-491
Webb JG, Chuang AM, Meier D, von Bardeleben RS, ... Hahn RT, Fam NP
JACC Cardiovasc Interv: 13 Mar 2022; 15:481-491 | PMID: 35272772
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Abstract

Risk Assessment of Coronary Obstruction During Transcatheter Aortic Valve Replacement: Insights From Post-BASILICA Computed Tomography.

Kitamura M, Wilde J, Dumpies O, Richter I, ... Holzhey D, Abdel-Wahab M
Objectives
The aim of this study was to examine the predictive value of preprocedural computed tomography (CT)-based risk stratification of coronary obstruction during transcatheter aortic valve replacement (TAVR) on the basis of geometric measurements on postprocedural CT.
Background
Proper patient selection for additional procedures to prevent coronary obstruction during TAVR has not been adequately evaluated.
Methods
Pre- and postprocedural computed tomographic scans of 28 patients treated using bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) and TAVR were analyzed. Using the postprocedural computed tomographic images, threatened coronary obstruction (TCO) was defined as: 1) ostial obstruction (adherence of the transcatheter heart valve [THV] to the coronary ostium with leaflet extension above the ostium); and/or 2) sinus sequestration (THV adherence to the sinotubular junction [STJ] with leaflet extension above the STJ) and was substratified into complete and incomplete types.
Results
A total of 51 leaflets were evaluated (88% surgical tissue valves) after excluding leaflets not visible on CT (n = 5). On postprocedural CT, complete TCO was observed in 25.4% (13 of 51 leaflets). On preprocedural CT, leaflets were at high risk for complete TCO (incidence 53%) if the virtual THV-to-coronary distance (VTC) was <3.0 mm, or if the virtual THV-to-STJ distance (VTSTJ) was <1.0 mm with STJ height - leaflet length <0 mm (leaflet-STJ mismatch). Leaflets were at low risk (incidence 0%) if the VTC was ≥3 mm and VTSTJ was ≥3.0 mm or STJ height - leaflet length was ≥+2.0 mm. Of 28 leaflets treated using BASILICA, complete TCO was seen in 35.7% (n = 10), due to sinus sequestration (100%) with coexisting ostial obstruction (30%). Actual coronary events occurred in 7.1% (n = 2) because of leaflet prolapse, corresponding to an absolute risk reduction by BASILICA of 29% (P = 0.021).
Conclusions
Risk assessment of coronary obstruction after TAVR may improve with a multiparametric approach incorporating VTC, VTSTJ, and leaflet-STJ mismatch. BASILICA appeared to reduce actual coronary events even in leaflets with anticipated coronary obstruction.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Mar 2022; 15:496-507
Kitamura M, Wilde J, Dumpies O, Richter I, ... Holzhey D, Abdel-Wahab M
JACC Cardiovasc Interv: 13 Mar 2022; 15:496-507 | PMID: 35272774
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Abstract

Propensity-Matched 1-Year Outcomes Following Transcatheter Aortic Valve Replacement in Low-Risk Bicuspid and Tricuspid Patients.

Deeb GM, Reardon MJ, Ramlawi B, Yakubov SJ, ... Huang J, Forrest JK
Objectives
The aim of this study was to compare 1-year outcomes after transcatheter aortic valve replacement (TAVR) in low surgical risk patients with bicuspid aortic stenosis to patients with tricuspid aortic stenosis.
Background
The pivotal TAVR trials excluded patients with bicuspid aortic valves. The Low Risk Bicuspid Study 30-day primary endpoint of death or disabling stroke was 1.3%.
Methods
The Low Risk Bicuspid Study is a prospective, single-arm, TAVR trial that enrolled patients from 25 U.S. sites. A screening committee confirmed bicuspid anatomy and valve classification on computed tomography using the Sievers classification. Valve sizing was by annular measurements. An independent clinical events committee adjudicated all serious adverse events, and an independent core laboratory assessed all echocardiograms. The 150 patients from the Low Risk Bicuspid Study were propensity matched to the TAVR patients in the randomized Evolut Low Risk Trial using the 1:1 5- to-1-digit greedy method, resulting in 145 pairs.
Results
All-cause mortality or disabling stroke at 1 year was 1.4% in the bicuspid and 2.8% in the tricuspid group (P = 0.413). A pacemaker was implanted in 16.6% of bicuspid and 17.9% of tricuspid patients (P = 0.741). The effective orifice area was similar between groups at 1 year (2.2 ± 0.7 cm2 vs 2.3 ± 0.6 cm2, P = 0.677) as was the mean gradient (8.7 ± 3.9 mm Hg vs 8.5 ± 3.1 mm Hg, P = 0.754). Fewer patients in the bicuspid group had mild or worse paravalvular leak (21.3% vs 42.6%, P < 0.001).
Conclusions
There were no significant differences in clinical or forward flow hemodynamic outcomes between the propensity-matched groups at 1 year.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Mar 2022; 15:511-522
Deeb GM, Reardon MJ, Ramlawi B, Yakubov SJ, ... Huang J, Forrest JK
JACC Cardiovasc Interv: 13 Mar 2022; 15:511-522 | PMID: 35272776
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Impact:
Abstract

The PARTNER 3 Bicuspid Registry for Transcatheter Aortic Valve Replacement in Low-Surgical-Risk Patients.

Williams MR, Jilaihawi H, Makkar R, O\'Neill WW, ... Lu M, Webb JG
Objectives
The study compared 1-year outcomes between transcatheter aortic valve replacement (TAVR) patients with bicuspid aortic valve (BAV) morphology and clinically similar patients having tricuspid aortic valve (TAV) morphology.
Background
There are limited prospective data on TAVR using the SAPIEN 3 device in low-surgical-risk patients with severe, symptomatic aortic stenosis and bicuspid anatomy.
Methods
Low-risk, severe aortic stenosis patients with BAV were candidates for the PARTNER 3 (Placement of Aortic Transcatheter Valves 3) (P3) bicuspid registry or the P3 bicuspid continued access protocol. Patients treated in these registries were pooled and propensity score matched to TAV patients from the P3 randomized TAVR trial. Outcomes were compared between groups. The primary endpoint was the 1-year composite rate of death, stroke, and cardiovascular rehospitalization.
Results
Of 320 total submitted BAV patients, 169 (53%) were treated, and most were Sievers type 1. The remaining 151 patients were excluded caused by anatomic or clinical criteria. Propensity score matching with the P3 TAVR cohort (496 patients) yielded 148 pairs. There were no differences in baseline clinical characteristics; however, BAV patients had larger annuli and they experienced longer procedure duration. There was no difference in the primary endpoint between BAV and TAV (10.9% vs 10.2%; P = 0.80) or in the rates of the individual components (death: 0.7% vs 1.4%; P = 0.58; stroke: 2.1% vs 2.0%; P = 0.99; cardiovascular rehospitalization: 9.6% vs 9.5%; P = 0.96).
Conclusions
Among highly select bicuspid aortic stenosis low-surgical-risk patients without extensive raphe or subannular calcification, TAVR with the SAPIEN 3 valve demonstrated similar outcomes to a matched cohort of patients with tricuspid aortic stenosis.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Mar 2022; 15:523-532
Williams MR, Jilaihawi H, Makkar R, O'Neill WW, ... Lu M, Webb JG
JACC Cardiovasc Interv: 13 Mar 2022; 15:523-532 | PMID: 35272777
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Impact:
Abstract

The Impact of Intravascular Ultrasound on Femoropopliteal Artery Endovascular Interventions: A Randomized Controlled Trial.

Allan RB, Puckridge PJ, Spark JI, Delaney CL
Objectives
The aim of this study was to investigate whether the addition of intravascular ultrasound (IVUS) guidance during femoropopliteal artery interventions reduced the rate of binary restenosis within 12 months compared with angiographic guidance alone.
Background
IVUS is more accurate than angiography for assessment of vessel size and disease severity. Low-level studies suggest that the use of IVUS in femoropopliteal endovascular interventions improves outcomes, but currently, no level 1 evidence exists.
Methods
This was a prospective single-center trial of 150 patients undergoing femoropopliteal endovascular intervention, randomized (1:1) to guidance by angiography or angiography and IVUS. The primary outcome measure was freedom from binary restenosis, on duplex ultrasound, within 12 months. Secondary outcomes included clinically driven target lesion revascularization, disagreements in imaging findings between modalities, and changes in treatment caused by IVUS.
Results
Freedom from binary restenosis at 12 months was significantly higher in the IVUS group (72.4% vs 55.4%; P = 0.008). There was no significant difference between groups for clinically directed target lesion revascularization (84.2% and 82.4%; P = 0.776). Mean vessel diameter was significantly larger with IVUS (5.60 mm vs 5.10 mm; P < 0.001). A change in treatment occurred caused by IVUS in 79% of cases. Binary restenosis was lower in the IVUS group for cases treated with drug-coated balloons (9.1% vs 37.5%; P = 0.001).
Conclusions
The use of IVUS resulted in a significant reduction in the rate of restenosis after endovascular intervention. This is the first randomized controlled trial to demonstrate that IVUS improves outcomes in femoropopliteal interventions. This benefit may primarily relate to cases treated with drug-coated balloons. (Does the use of intravascular ultrasound improve outcomes of endovascular interventional procedures for peripheral vascular disease of the superficial femoral artery or popliteal artery?; ACTRN12614000006640).

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Mar 2022; 15:536-546
Allan RB, Puckridge PJ, Spark JI, Delaney CL
JACC Cardiovasc Interv: 13 Mar 2022; 15:536-546 | PMID: 35272779
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Abstract

Balloon-Expandable Valve for Treatment of Evolut Valve Failure: Implications on Neoskirt Height and Leaflet Overhang.

Akodad M, Sellers S, Landes U, Meier D, ... Webb JG, Sathananthan J
Objectives
This study sought to determine the degree of Evolut (Medtronic) leaflet pinning, diameter expansion, leaflet overhang, and performance at different implant depths of the balloon-expandable Sapien 3 (S3, Edwards Lifesciences LLC) transcatheter heart valve (THV) within the Evolut THV.
Background
Preservation of coronary access and flow is a major factor when considering the treatment of failed Evolut THVs.
Methods
An in vitro study was performed with 20-, 23-, 26-, and 29-mm S3 THVs deployed within 23-, 26-, 29-, and 34-mm Evolut R THVs, respectively. The S3 outflow was positioned at various depths at node 4, 5, and 6 of the Evolut R. Neoskirt height, leaflet overhang, performance, and Evolut R valve housing diameter expansion were assessed under physiological conditions as per ISO 5840-3 standard.
Results
The neoskirt height for the Evolut R was shorter when the S3 outflow was positioned at node 4 compared with node 6 (node 4 height for 23 mm = 16.3 mm, 26 mm = 17.1 mm, 29 mm = 18.3 mm, and 34 mm = 19.9 mm vs node 6 height for 23 mm = 23.9 mm, 26 mm = 23.4 mm, 29 mm = 24.7 mm, and 34 mm = 27 mm Evolut R). All configurations exhibited acceptable hydrodynamic performance irrespective of the degree of leaflet overhang, except the 29-mm S3 implanted in 34-mm Evolut R at node 4 (regurgitant fraction >20%). The valve housing radius of the index Evolut R increased when the S3 was implanted, with the increase ranging from 0 to 2.5 mm.
Conclusions
Placement of the S3 at a lower implant position within an index Evolut R reduces the neoskirt height with no significant compromise to S3 valve function despite a higher degree of leaflet overhang. Low S3 implantation may facilitate future coronary access after redo transcatheter aortic valve replacement.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 27 Feb 2022; 15:368-377
Akodad M, Sellers S, Landes U, Meier D, ... Webb JG, Sathananthan J
JACC Cardiovasc Interv: 27 Feb 2022; 15:368-377 | PMID: 35210043
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Abstract

Solving the Pulmonary Hypertension Paradox in Patients With Severe Tricuspid Regurgitation by Employing Artificial Intelligence.

Fortmeier V, Lachmann M, Körber MI, Unterhuber M, ... Lurz P, Rudolph V
Objectives
This study aimed to improve echocardiographic assessment of pulmonary hypertension (PH) in patients presenting with severe tricuspid regurgitation (TR).
Background
Echocardiographic assessment of PH in patients with severe TR carries several pitfalls for underestimation, hence concealing the true severity of PH in very sick patients in particular, and ultimately obscuring the impact of PH on survival after transcatheter tricuspid valve intervention (TTVI).
Methods
All patients in this study underwent TTVI for severe TR between 2016 and 2020. To predict the mean pulmonary artery pressure (mPAP) solely based on echocardiographic parameters, we trained an extreme gradient boosting (XGB) algorithm. The derivation cohort was constituted by 116 out of 162 patients with both echocardiography and right heart catheterization data, preprocedurally obtained, from a bicentric registry. Moreover, 142 patients from an independent institution served for external validation.
Results
Systolic pulmonary artery pressure was consistently underestimated by echocardiography in comparison to right heart catheterization (40.3 ± 15.9 mm Hg vs 44.1 ± 12.9 mm Hg; P = 0.0066), and the assessment was most discrepant among patients with severe defects of the tricuspid valve and impaired right ventricular systolic function. Using 9 echocardiographic parameters as input variables, an XGB algorithm could reliably predict mPAP levels (R = 0.96, P < 2.2 × 10-16). Moreover, patients with elevations in predicted mPAP levels ≥29.9 mm Hg showed significantly reduced 2-year survival after TTVI (58.3% [95% CI: 41.7%-81.6%] vs 78.8% [95% CI: 68.7%-90.5%]; P = 0.026). Importantly, the poor prognosis associated with elevation in predicted mPAP levels was externally confirmed (HR for 2-year mortality: 2.9 [95% CI: 1.5-5.7]; P = 0.002).
Conclusions
PH in patients with severe TR can be reliably assessed based on echocardiographic parameters in conjunction with an XGB algorithm, and elevations in predicted mPAP levels translate into increased mortality after TTVI.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 27 Feb 2022; 15:381-394
Fortmeier V, Lachmann M, Körber MI, Unterhuber M, ... Lurz P, Rudolph V
JACC Cardiovasc Interv: 27 Feb 2022; 15:381-394 | PMID: 35210045
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Abstract

Management and Outcome of Failed Percutaneous Edge-to-Edge Mitral Valve Plasty: Insight From an International Registry.

Mangieri A, Melillo F, Montalto C, Denti P, ... Maisano F, Colombo A
Objectives
This study evaluated the incidence, management, and outcome of patients who experienced MitraClip (Abbott Vascular) failure secondary to loss of leaflet insertion (LLI), single leaflet detachment (SLD), or embolization.
Background
Transcatheter edge-to-edge repair with MitraClip is an established therapy for the treatment of mitral regurgitation (MR), but no data exist regarding the prevalence and outcome according to the mode of clip failure.
Methods
Between January 2009 and December 2020, we retrospectively screened 4,294 procedures of MitraClip performed in 19 centers. LLI was defined as damage to the leaflet where the MitraClip was attached, SLD as demonstration of complete separation between the device and a single leaflet tissue, and clip embolization as loss of contact between MitraClip and both leaflets.
Results
A total of 147 cases of MitraClip failure were detected (overall incidence = 3.5%), and these were secondary to LLI or SLD in 47 (31.9%) and 99 (67.3%) cases, respectively, whereas in 1 (0.8%) case clip embolization was observed. MitraClip failure occurred in 67 (45.5%) patients with functional MR, in 64 (43.5%) patients with degenerative MR, and 16 (10.8%) with mixed etiology. Although the majority of MitraClip failures were detected before discharge (47 intraprocedural and 42 in the hospital), up to 39.5% of cases were diagnosed at follow-up. In total, 80 (54.4%) subjects underwent a redo procedure, either percutaneously with MitraClip (n = 51, 34.7%) or surgically (n = 36, 24.5%) including 4 cases of surgical conversion of the index procedure and 7 cases of bailout surgery after unsuccessful redo MitraClip. After a median follow-up of 163 days (IQR: 22-720 days), 50 (43.9%) subjects presented moderate to severe MR, and 43 (29.3%) patients died. An up-front redo MitraClip strategy was associated with a trend toward a reduced rate of death at follow-up vs surgical or conservative management (P = 0.067), whereas postprocedural acute kidney injury, age, and moderate to severe tricuspid regurgitation were independent predictors of death.
Conclusions
MitraClip failure secondary to LLI and SLD is not a rare phenomenon and may occur during and also beyond hospitalization. Redo MitraClip strategy demonstrates a trend toward a reduced risk of death compared with bailout surgery and conservative management. A third of those patients remained with more than moderate MR and had substantial mortality at the intermediate-term follow-up.

Copyright © 2022 American College of Cardiology Foundation. All rights reserved.

JACC Cardiovasc Interv: 27 Feb 2022; 15:411-422
Mangieri A, Melillo F, Montalto C, Denti P, ... Maisano F, Colombo A
JACC Cardiovasc Interv: 27 Feb 2022; 15:411-422 | PMID: 35210047
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Abstract

Thrombotic Risk and Cardiovascular Events in Patients With Revascularization Deferral After Fractional Flow Reserve Assessment.

Shiono Y, Kuramitsu S, Matsuo H, Horie K, ... Tanaka N, J-CONFIRM Registry Investigators
Objectives
The aim of this study was to evaluate the impact of thrombotic risk on the occurrence of cardiovascular events in patients with coronary artery disease with deferred revascularization after fractional flow reserve (FFR) measurements.
Background
Deferral of revascularization on the basis of FFR is generally considered to be safe, but after deferral, some patients have cardiovascular events over time.
Methods
From J-CONFIRM registry (Long-Term Outcomes of Japanese Patients With Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry), 1,263 patients with deferral of revascularization on the basis of FFR were evaluated. The association between thrombotic risk as assessed by CREDO-Kyoto (Coronary Revascularization Demonstrating Outcome Study in Kyoto) thrombotic score and 5-year target vessel failure (TVF) and major adverse cardiac and cerebrovascular events (MACCE) was investigated.
Results
FFR and high thrombotic risk (HTR) were associated with increased risk for 5-year TVF (FFR per 0.01-unit decrease: HR: 1.08; 95% CI: 1.05-1.11; P < 0.001; HTR: HR: 2.16; 95% CI: 1.37-3.39; P < 0.001) and MACCE (FFR per 0.01-unit decrease: HR: 1.05; 95% CI: 1.02-1.06; P < 0.001; HTR: HR: 2.11; 95% CI: 1.56-2.84; P = 0.001). Patients with HTR had higher risk for 5-year TVF (HR: 2.30; 95% CI: 1.45-3.66; P < 0.001) and MACCE (HR: 2.34; 95% CI: 1.75-3.13; P < 0.001) than those without HTR, even when they had negative FFR.
Conclusions
Assessment of thrombotic risk provides additional prognostic value to FFR in predicting 5-year TVF and MACCE in patients with deferral of revascularization after FFR measurements. (Long-Term Outcomes of Japanese Patients With Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry; UMIN000014473).

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 27 Feb 2022; 15:427-439
Shiono Y, Kuramitsu S, Matsuo H, Horie K, ... Tanaka N, J-CONFIRM Registry Investigators
JACC Cardiovasc Interv: 27 Feb 2022; 15:427-439 | PMID: 35210049
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Abstract

Effect of Wire Jailing at Side Branch in 1-Stent Strategy for Coronary Bifurcation Lesions.

Choi YJ, Lee SJ, Kim BK, Hong SJ, ... Hong MK, Jang Y
Objectives
This study aimed to determine whether side branch (SB) wire jailing before main vessel (MV) stenting could prevent SB occlusion after the 1-stent strategy for bifurcation percutaneous coronary intervention.
Background
The benefits of SB wire jailing in the 1-stent strategy remain unclear.
Methods
From the COBIS (Coronary Bifurcation Stenting) III registry, 1,890 patients with bifurcation lesions who underwent the 1-stent strategy using second-generation drug-eluting stents were identified and classified into 2 groups according to the use of SB wire jailing: wire jailing (n = 819) and non-wire jailing (n = 1,071). The incidence of SB occlusion (Thrombolysis In Myocardial Infarction flow grade <3) and target lesion failure (cardiac death, myocardial infarction, or target lesion revascularization) was compared.
Results
The incidence of final SB occlusion was not significantly different between wire jailing (1.8%) vs non-wire jailing (2.9%; P = 0.182). However, wire jailing at the SB was a significant protective factor for SB occlusion after MV stenting on multivariate analysis and was significantly associated with a lower incidence of SB occlusion in patients with significant stenoses (≥60%) at the SB (5.1% vs 11.3%; odds ratio: 0.42; 95% CI: 0.19-0.89; P = 0.028) or MV (3.1% vs 6.2%; odds ratio: 0.49; 95% CI: 0.24-0.95; P = 0.039). During follow-up (median 52 months), the incidence of target lesion failure was not significantly different between wire jailing and non-wire jailing (7.6% vs 6.3%; P = 0.343).
Conclusions
During bifurcation percutaneous coronary intervention with the 1-stent strategy, wire jailing at the SB was associated with a lower rate of final SB occlusion following MV stenting in patients with severe stenoses at the SB or MV but not with overall bifurcation lesions. Long-term clinical outcomes were comparable between the 2 groups.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 27 Feb 2022; 15:443-455
Choi YJ, Lee SJ, Kim BK, Hong SJ, ... Hong MK, Jang Y
JACC Cardiovasc Interv: 27 Feb 2022; 15:443-455 | PMID: 35210051
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This program is still in alpha version.