Journal: JACC Cardiovasc Interv

Sorted by: date / impact
Abstract

Impact of Left Ventricular Outflow Tract Calcification on Procedural Outcomes After Transcatheter Aortic Valve Replacement.

Okuno T, Asami M, Heg D, Lanz J, ... Windecker S, Pilgrim T
Objectives
This study aimed to systematically assess the importance of left ventricular outflow tract (LVOT) calcification on procedural outcomes and device performances with contemporary transcatheter heart valve (THV) systems.
Background
LVOT calcification has been associated with adverse clinical outcomes after transcatheter aortic valve replacement (TAVR). However, the available evidence is limited to observational data with modest numbers and incomplete assessment of the effect of the different THV systems.
Methods
In a retrospective analysis of a prospective single-center registry, LVOT calcification was assessed in a semiquantitative fashion. Moderate or severe LVOT calcification was documented in the presence of 2 nodules of calcification, or 1 extending >5 mm in any direction, or covering >10 % of the perimeter of the LVOT.
Results
Among 1,635 patients undergoing TAVR between 2007 and 2018, moderate or severe LVOT calcification was found in 407 (24.9%). Patients with moderate or severe LVOT calcification had significantly higher incidences of annular rupture (2.3% vs. 0.2%; p < 0.001), bailout valve-in-valve implantation (2.9% vs. 0.8%; p = 0.004), and residual aortic regurgitation (11.1% vs. 6.3%; p = 0.002). Balloon-expandable valves conferred a higher risk of annular rupture in the presence of moderate or severe LVOT calcification (4.0% vs. 0.4%; p = 0.002) as compared with the other valve designs. There was no significant interaction of valve design or generation and LVOT calcification with regard to the occurrence of bailout valve-in-valve implantation and residual aortic regurgitation.
Conclusions
Moderate or severe LVOT calcification confers increased risks of annular rupture, residual aortic regurgitation, and implantation of a second valve. The risk of residual aortic regurgitation is consistent across valve designs and generations. (SWISS TAVI Registry; NCT01368250).

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 09 Aug 2020; 13:1789-1799
Okuno T, Asami M, Heg D, Lanz J, ... Windecker S, Pilgrim T
JACC Cardiovasc Interv: 09 Aug 2020; 13:1789-1799 | PMID: 32763071
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Abstract

Impact of Repositioning on Outcomes Following Transcatheter Aortic Valve Replacement With a Self-Expandable Valve.

Attizzani GF, Dallan LAP, Markowitz A, Yakubov SJ, ... Huang J, Popma JJ
Objectives
This study sought to compare outcomes following transcatheter aortic valve replacement when valve repositioning was performed (repositioned group) versus procedures without repositioning (nonrepositioned group).
Background
The Evolut R and Evolut PRO valves were designed to allow repositioning during deployment, yet the effect of repositioning on clinical outcomes remains unclear.
Methods
Patients implanted with the Evolut R or PRO valve from the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial continued access study and the Evolut Low Risk Trial between June 2016 and November 2018 were combined. Baseline multidetector computed tomography data were analyzed for the Evolut Low Risk Trial patients. The primary outcomes were the rate of all-cause mortality and the rate of disabling stroke 30 days. Secondary outcomes were per Valve Academic Research Consortium-2.
Results
The Evolut R or PRO valve was implanted in 946 patients, and repositioning was performed in 318 (33.6%). Compared with patients in the nonrepositioned group, patients in the repositioned group had lower Society of Thoracic Surgeons score (2.3 ± 1.3% vs. 2.6 ± 1.4%; p < 0.001) and fewer prior percutaneous coronary interventions (11.9% vs. 19.7%; p = 0.003). There were no differences in baseline multidetector computed tomography parameters between groups. There were no differences in the primary outcome of death (0.3% vs. 0.3%; p = 0.99) or disabling stroke (0.3% vs. 0.5%; p = 0.71) at 30 days or 1 year (1.9% vs. 2.9%; p = 0.44; and 0.8% vs. 0.9%%; p = 0.79, respectively).
Conclusions
The utilization of the repositioning feature of the Evolut valves was safe, and no differences in death or disabling stroke were observed at 30 days or 1 year between groups. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283; 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 © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 09 Aug 2020; 13:1816-1824
Attizzani GF, Dallan LAP, Markowitz A, Yakubov SJ, ... Huang J, Popma JJ
JACC Cardiovasc Interv: 09 Aug 2020; 13:1816-1824 | PMID: 32763073
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Abstract

Role of Post-Stent Physiological Assessment in a Risk Prediction Model After Coronary Stent Implantation.

Hwang D, Lee JM, Yang S, Chang M, ... Kakuta T, Koo BK
Objectives
The aim of this study was to develop a risk model incorporating clinical, angiographic, and physiological parameters to predict future clinical events after drug-eluting stent implantation.
Background
Prognostic factors after coronary stenting have not been comprehensively investigated.
Methods
A risk model to predict target vessel failure (TVF) at 2 years was developed from 2,200 patients who underwent second-generation drug-eluting stent implantation and post-stent fractional flow reserve (FFR) measurement. TVF was defined as a composite of cardiac death, target vessel myocardial infarction, and clinically driven target vessel revascularization. A random survival forest model with automatic feature selection by minimal depth analysis was used for risk model development.
Results
During 2 years of follow-up, the cumulative incidence of TVF was 5.9%. From clinical, angiographic, and physiological parameters, 6 variables were selected for the risk model in order of importance within the model as follows: total stent length, post-stent FFR, age, post-stent percentage diameter stenosis, reference vessel diameter, and diabetes mellitus. Harrell\'s C index of the random survival forest model was 0.72 (95% confidence interval [CI]: 0.62 to 0.82). This risk model showed better prediction ability than models with clinical risk factors alone (Harrell\'s C index = 0.55; 95% CI: 0.41 to 0.59; p for comparison = 0.005) and with clinical risk factors and angiographic parameters (Harrell\'s C index = 0.65; 95% CI: 0.52 to 0.77; p for comparison = 0.045). When the patients were divided into 2 groups according to the median of total stent length (30 mm), post-stent FFR and total stent length showed the highest variable importance in the short- and long-stent groups, respectively.
Conclusions
A risk model incorporating clinical, angiographic, and physiological predictors can help predict the risk for TVF at 2 years after coronary stenting. Total stent length and post-stent FFR were the most important predictors. (International Post PCI FFR Registry; NCT04012281).

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 26 Jul 2020; 13:1639-1650
Hwang D, Lee JM, Yang S, Chang M, ... Kakuta T, Koo BK
JACC Cardiovasc Interv: 26 Jul 2020; 13:1639-1650 | PMID: 32703590
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Abstract

Predictors of Outcomes Following Transcatheter Edge-to-Edge Mitral Valve Repair.

Ben-Shoshan J, Overtchook P, Buithieu J, Mousavi N, ... Windecker S, Piazza N

Transcatheter edge-to-edge mitral valve repair is a viable alternative to surgery in patients with severe mitral regurgitation and high surgical risk. Yet the specific group of patients who would optimally benefit from this therapy remains to be determined. Selection of patients for transcatheter strategy is currently based on surgical prognostic scores and technical feasibility. Meanwhile, various clinical, anatomic, and procedural factors have been recently recognized as predictors of adverse outcomes following transcatheter edge-to-edge mitral valve repair, including device failure, recurrent mitral regurgitation, and mortality. Integration of these prognostic factors in the decision-making process of the heart team might improve patient management and outcomes. Herein, the authors review the different factors related to symptomatic status, comorbidity, serum biomarkers, echocardiographic findings, and procedural technique that have been identified as independent predictors of adverse outcome following transcatheter edge-to-edge mitral valve repair and discuss their potential application in everyday clinical practice.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 09 Aug 2020; 13:1733-1748
Ben-Shoshan J, Overtchook P, Buithieu J, Mousavi N, ... Windecker S, Piazza N
JACC Cardiovasc Interv: 09 Aug 2020; 13:1733-1748 | PMID: 32763070
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Abstract

Titanium-Nitride-Oxide-Coated Versus Everolimus-Eluting Stents in Acute Coronary Syndrome: The Randomized TIDES-ACS Trial.

Tonino PAL, Pijls NHJ, Collet C, Nammas W, ... Karjalainen PP,
Objectives
This study sought to compare next-generation cobalt-chromium-based titanium-nitride-oxide (TiNO)-coated stents with a platinum-chromium-based biodegradable polymer everolimus-eluting stent (EES) in patients with acute coronary syndrome (ACS).
Background
Previous generation TiNO-coated stents showed acceptable performance in patients with ACS.
Methods
In a multicenter, randomized trial, we randomly assigned 1,491 ACS patients (2:1) to receive either a TiNO-coated stent (n = 989) or EES (n = 502). The primary endpoint was the rate of a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target lesion revascularization at 12-month follow-up. The co-primary endpoint was a composite of cardiac death, MI, or major bleeding at 18 months.
Results
A primary endpoint event occurred in 6.3% of patients in the TiNO-coated stent group versus in 7.0% in the EES group (hazard ratio: 0.93; 95% confidence interval: 0.71 to 1.22; p = 0.66 for superiority; p < 0.001 for noninferiority). A co-primary endpoint event occurred in 3.7% of the patients in the TiNO group and in 7.8% in the EES group (hazard ratio: 0.64; 95% confidence interval: 0.51 to 0.80; p = 0.001). TiNO-coated stents were associated with lower rates of cardiac death (0.6% vs. 2.6%; p = 0.002) and MI (2.2% vs. 5.0%; p = 0.007) at 18 months of follow-up. Rates of target lesion revascularization were not significantly different at 18 months (5.8% vs. 4.4%; p = 0.27).
Conclusions
In patients with ACS, cobalt-chromium-based TiNO-coated stents were noninferior to platinum-chromium-based biodegradable polymer EES for major cardiac events at 12 months, and were superior for the co-primary endpoint of cardiac death, MI, and bleeding at 18 months. (Comparison of Titanium-Nitride-Oxide-Coated Bio-Active-Stent (Optimax™) to the Drug (Everolimus) -Eluting Stent (Synergy™) in Acute Coronary Syndrome [TIDES-ACS]; NCT02049229).

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 26 Jul 2020; 13:1697-1705
Tonino PAL, Pijls NHJ, Collet C, Nammas W, ... Karjalainen PP,
JACC Cardiovasc Interv: 26 Jul 2020; 13:1697-1705 | PMID: 32703593
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Abstract

Similarities and Differences Between Primary Percutaneous Coronary Intervention and Mechanical Thrombectomy.

Carvalho de Campos Martins E, Luiz de Melo Bernardi F, Maia Junior OT, Micari A, ... Cremonesi A, Castriota F

Acute ischemic stroke is among the leading causes of mortality and disability worldwide. Since 2015, as was the case for primary percutaneous coronary intervention for acute myocardial infarction, catheter-based reperfusion via mechanical thrombectomy (MT) has become the gold-standard treatment for acute ischemic stroke caused by large-vessel occlusion. Despite that, only a fraction of the world\'s population currently would be able to undergo MT in time, mostly because of the scarcity of 24/7 coverage by neurointerventionalists to deal with this enormous burden. Interventional cardiologists have thus been considered a logical option to aid in combating this vast demand to diminish the burden of acute ischemic stroke. However, despite some seemingly evident similarities between primary percutaneous coronary intervention and MT, for interventional cardiologists to enter this new field, they must be well trained and fully aware of all the clinical, technical, and environmental differences between these two scenarios. The main objective of this state-of-the-art paper is to serve as an introductory and comprehensive guide to familiarize the interventional cardiology community with the most critical technical aspects of MT.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 26 Jul 2020; 13:1683-1696
Carvalho de Campos Martins E, Luiz de Melo Bernardi F, Maia Junior OT, Micari A, ... Cremonesi A, Castriota F
JACC Cardiovasc Interv: 26 Jul 2020; 13:1683-1696 | PMID: 32703592
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Abstract

Use of Dual-Layered Stents for Carotid Artery Angioplasty: 1-Year Results of a Patient-Based Meta-Analysis.

Stabile E, de Donato G, Musialek P, Deloose K, ... Micari A, Esposito G
Objectives
This study sought to evaluate 1-year safety and efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS).
Background
Small clinical studies evaluating 1-year outcomes of CAS performed with 2 available DLS, Roadsaver (RS) (Terumo Corp., Tokyo, Japan) and CGuard (CG) (InspireMD, Boston, Massachusetts), have been published.
Methods
The authors performed an individual patient-level meta-analysis including studies enrolling more than 100 CAS with DLS. The primary endpoint was the death and stroke rate; secondary endpoints were restenosis and in-stent thrombosis rates at 1 year.
Results
Patients were divided into 2 groups according to DLS (RS n = 250; CG n = 306). At 1 year, 11 patients died (1.97%), 7 patients in the group RS (2.8%) and 4 patients in the CG one (1.31%); and 10 strokes occurred, 4 in the group RS (1.6%) and 6 in the CG one (1.96%). Overall death and stroke rate was 3.77% (n = 21), 11 events in the group RS group (4.4%) and 10 in the CG group (3.27%). Symptomatic status was the only predictor of death and or stroke. At 1 year, restenosis occurred in 12 patients (2.1%), 10 in the group RS (4%) and 2 in the CG one (0.65%) (p = 0.007). In-stent thrombosis occurred in 1 patient (0.18%) in the CG group (0.32%). RS use was the only independent predictor of restenosis.
Conclusions
This study suggests that DLS use for CAS is associated with a low 1-year death and stroke rate, and the specific DLS stent used could affect the restenosis rate.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 26 Jul 2020; 13:1709-1715
Stabile E, de Donato G, Musialek P, Deloose K, ... Micari A, Esposito G
JACC Cardiovasc Interv: 26 Jul 2020; 13:1709-1715 | PMID: 32703595
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Abstract

The Impact of Coronary Physiology on Contemporary Clinical Decision Making.

Kogame N, Ono M, Kawashima H, Tomaniak M, ... Onuma Y, Serruys PW

Physiological assessment of coronary artery disease (CAD) has become one of the cornerstones of decision making for myocardial revascularization, with a large body of evidence supporting the benefits of using fractional flow reserve and other pressure-based indexes for functional assessment of coronary stenoses. Furthermore, physiology allows the identification of specific vascular dysfunction mechanisms in patients without obstructive CAD. Currently, more than 10 modalities of functional coronary assessment are available, although the overall adoption of these physiological tools, of either intracoronary or image-based nature, is still low. In this paper the authors review these modalities of functional coronary assessment according to their timing of use: outside the catheterization laboratory, in the catheterization laboratory prior to the percutaneous coronary intervention (PCI), and in the catheterization laboratory during or after PCI. The authors discuss how the information obtained can be used in setting the indication for PCI, in planning and guiding the procedure, and in documenting the final functional result of the intervention. The advantages and limitations of each modality in each setting are discussed. Furthermore, the key value of intracoronary physiology in diagnosing mechanisms of microcirculatory dysfunction, which account for the presence of ischemia in many patients without obstructive CAD, is revisited. On the basis of the opportunities generated by the multiplicity of diagnostic tools described, the authors propose an algorithmic approach to physiological coronary investigations in clinical practice, with the key aims of: 1) avoiding unneeded revascularization procedures; 2) improving procedural PCI and long-term outcomes in patients with obstructive CAD; and 3) diagnosing vascular dysfunction mechanisms that can be effectively treated in patients with NOCAD. The authors believe that such structured approach may also contribute to the wider adoption of available technologies for functional assessment of patients with CAD.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 26 Jul 2020; 13:1617-1638
Kogame N, Ono M, Kawashima H, Tomaniak M, ... Onuma Y, Serruys PW
JACC Cardiovasc Interv: 26 Jul 2020; 13:1617-1638 | PMID: 32703589
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Abstract

Management and Outcomes of Transvenous Pacing Leads in Patients Undergoing Transcatheter Tricuspid Valve Replacement.

Anderson JH, McElhinney DB, Aboulhosn J, Zhang Y, ... Cabalka AK,
Objectives
The aim of this study was to determine the prevalence of pacemaker lead-related complications following transcatheter tricuspid valve replacement (TTVR).
Background
The rate of permanent pacemaker implantation following tricuspid valve (TV) surgery is high, and many patients have transvenous leads. The feasibility, safety, and outcomes of subsequently performing TTVR in the setting of transvenous pacemaker leads have not been established.
Methods
The VIVID (Valve-in-Valve International Database) registry was used to review 329 patients who underwent TTVR following TV repair or replacement. Patients were subdivided into 3 cohorts for intergroup comparisons: no lead, epicardial lead, and transvenous lead (entrapped or not entrapped during the TTVR procedure).
Results
Of 329 patients who underwent TTVR, 128 (39%) had prior pacing systems in place, 70 with epicardial and 58 with transvenous leads. A total of 31 patients had leads passing through the TV. Three patients had the right ventricular (RV) lead extracted prior to TTVR. The remaining 28 patients had the RV lead entrapped between the transcatheter TV implant and the surgical valve (n = 22) or the repaired TV (n = 6). One patient had displacement of the RV lead during the procedure, and 2 experienced lead failure during follow-up. Overall, there was no significant difference in the cumulative incidences of competing outcomes (death, TV reintervention, TV dysfunction) between patients with and those without pacing leads or entrapped RV leads.
Conclusions
TTVR in the setting of trans-TV pacemaker leads without lead extraction or re-replacement can be performed safely with a low risk for complications, offering an alternative to surgical TV replacement.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 07 Aug 2020; epub ahead of print
Anderson JH, McElhinney DB, Aboulhosn J, Zhang Y, ... Cabalka AK,
JACC Cardiovasc Interv: 07 Aug 2020; epub ahead of print | PMID: 32800497
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Abstract

Strategies for Successful Catheterization Laboratory Recovery From the COVID-19 Pandemic.

Poulin MF, Pinto DS

As the world slowly starts to recover from the coronavirus disease-2019 pandemic, health care systems are now thinking about resuming elective cardiovascular procedures, including procedures in cardiac catheterization laboratories. Rebooting catheterization laboratories will be an arduous process, in part because of limited health care resources, new processes, and fears stemming from the coronavirus disease-2019 pandemic. The authors propose a detailed phased-in approach that considers clinical, patient-centered, and operational strategies to safely and effectively reboot catheterization laboratory programs during these unprecedented times. This model balances the delivery of essential cardiovascular care with reduced exposure and preservation of resources. The guiding principles detailed in this review can be used by catheterization laboratory programs when restarting elective interventional procedures.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 23 Aug 2020; 13:1951-1957
Poulin MF, Pinto DS
JACC Cardiovasc Interv: 23 Aug 2020; 13:1951-1957 | PMID: 32819485
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Abstract

Shifting Paradigms in Cardiovascular Therapeutic Strategies During the COVID-19 Era.

Kornowski R

The coronavirus disease-19 (COVID-19) period have dictated a different approach to cardiac interventions at our medical institution. We prioritize emergent care geared toward lesser invasive approaches while minimizing hospitalization duration. This reflects upon coronary and structural/valvular cases altogether. Despite potential criticism of this approach, we believe it is the most appropriate therapeutic strategy for this unique period. Further investigation is needed to examine the external validity of our approach in other medical centers worldwide.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 23 Aug 2020; 13:1949-1950
Kornowski R
JACC Cardiovasc Interv: 23 Aug 2020; 13:1949-1950 | PMID: 32819484
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Abstract

Influence of Anatomical and Clinical Characteristics on Long-Term Prognosis of FFR-Guided Deferred Coronary Lesions.

Cho YK, Hwang J, Lee CH, Kim IC, ... Koo BK, Nam CW
Objectives
The aim of this study was to evaluate the clinical and anatomical features to predict the long-term outcomes in patients with fractional flow reserve (FFR)-guided deferred lesions, verified by intravascular ultrasound (IVUS).
Background
Deferral of nonsignificant lesion by FFR is associated with a low risk of clinical events. However, the impact of combined information on clinical and anatomical factors is not well known.
Methods
The study included 459 patients with 552 intermediate lesions who had deferred revascularization on the basis of a nonischemic FFR (>0.80). Grayscale IVUS was examined simultaneously. The primary endpoint was patient-oriented composite outcome (POCO) (a composite of all-cause death, myocardial infarction, and any revascularization) during 5-year follow-up.
Results
The rate of 5-year POCO was 9.8%. Diabetes mellitus (hazard ratio: 3.50; 95% confidence interval [CI]: 1.86 to 6.57; p < 0.001), left ventricular ejection fraction ≤40% (hazard ratio: 4.80; 95% CI: 1.57 to 14.63; p = 0.006), and positive remodeling (hazard ratio: 2.04; 95% CI: 1.03 to 4.03; p = 0.041) were independent predictors for POCO. When the lesions were classified according to the presence of the adverse clinical characteristics (diabetes, left ventricular ejection fraction ≤40%) or adverse plaque characteristics (positive remodeling, plaque burden ≥70%), the risk of POCO was incrementally increased (4.3%, 13.6%, and 21.3%, respectively; p < 0.001).
Conclusions
In patients with FFR-guided deferred lesions, 5-year clinical outcomes were excellent. Lesion-related anatomical factors from intravascular imaging as well as patient-related clinical factors could provide incremental information about future clinical risks.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 23 Aug 2020; 13:1907-1916
Cho YK, Hwang J, Lee CH, Kim IC, ... Koo BK, Nam CW
JACC Cardiovasc Interv: 23 Aug 2020; 13:1907-1916 | PMID: 32819479
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Abstract

Assessment of Vascular Dysfunction in Patients Without Obstructive Coronary Artery Disease: Why, How, and When.

Ford TJ, Ong P, Sechtem U, Beltrame J, ... Berry C,

Ischemic heart disease secondary to coronary vascular dysfunction causes angina and impairs quality of life and prognosis. About one-half of patients with symptoms and signs of ischemia turn out not to have obstructive coronary artery disease, and coronary vascular dysfunction may be relevant. Adjunctive tests of coronary vasomotion include guidewire-based techniques with adenosine and reactivity testing, typically by intracoronary infusion of acetylcholine. The CorMicA (Coronary Microvascular Angina) trial provided evidence that routine management guided by an interventional diagnostic procedure and stratified therapy improves angina and quality of life in patients with angina but no obstructive coronary artery disease. In this paper, the COVADIS study group provide a comprehensive review of why, how, and when coronary vascular dysfunction should be assessed invasively. They discuss the rationale through a shared understanding of vascular pathophysiology and clinical evidence. They propose a consensus approach to how an interventional diagnostic procedure is performed with focus on practical aspects. Finally, the authors discuss the clinical scenarios in patients with stable and acute coronary syndromes in which measurement of coronary vascular function may be helpful for patient care.

Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 23 Aug 2020; 13:1847-1864
Ford TJ, Ong P, Sechtem U, Beltrame J, ... Berry C,
JACC Cardiovasc Interv: 23 Aug 2020; 13:1847-1864 | PMID: 32819476
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Abstract

Prognostic Implications of Post-Intervention Resting Pd/Pa and Fractional Flow Reserve in Patients With Stent Implantation.

Shin D, Lee SH, Lee JM, Choi KH, ... Shin ES, Doh JH
Objectives
This study sought to investigate the prognostic implications of post-percutaneous coronary intervention (PCI) nonhyperemic pressure ratios compared with that of post-PCI fractional flow reserve (FFR).
Background
FFR measured after PCI has been shown to possess prognostic implications. However, the prognostic value of post-PCI nonhyperemic pressure ratios has not yet been clarified.
Methods
A total of 588 patients who underwent PCI with available both post-PCI FFR and resting distal coronary pressure-to-aortic pressure ratio (Pd/Pa) were analyzed. Post-PCI FFR and Pd/Pa were measured after successful angiographic stent implantation. The primary outcome was target vessel failure (TVF) up to 2 years, defined as a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization. Prognosis of patients according to post-PCI Pd/Pa was compared with that of post-PCI FFR.
Results
Despite angiographically successful PCI, 18.5% had post-PCI FFR ≤0.80 and 36.9% showed post-PCI Pd/Pa ≤0.92. In post-PCI Pd/Pa >0.92 group, 93.8% of patients showed post-PCI FFR >0.80. Conversely, 60.4% of patients showed post-PCI FFR >0.80 in post-PCI Pd/Pa ≤0.92 group. Although there was significant difference in TVF according to post-PCI FFR (≤0.80 vs. >0.80: 10.3% vs. 2.5%; p < 0.001) and Pd/Pa (≤0.92 vs. >0.92: 6.2% vs. 2.5%; p = 0.029), the reclassification ability of model for TVF was increased only with post-PCI FFR (net reclassification index 0.627; p = 0.003; integrated discrimination index 0.019; p = 0.015), but not with post-PCI Pd/Pa, compared with model including clinical factors. Compared with patients with post-PCI Pd/Pa >0.92, patients with post-PCI Pd/Pa ≤0.92 and FFR ≤0.80 had significantly higher risk of TVF (10.4% vs. 2.5%; adjusted hazard ratio: 4.204; 95% confidence interval: 1.521 to 11.618; p = 0.006); however, those with post-PCI Pd/Pa ≤0.92 but FFR >0.80 showed similar risk of TVF (3.5% vs. 2.5%; adjusted hazard ratio: 1.327; 95% confidence interval: 0.398 to 4.428; p = 0.645).
Conclusions
Over one-half of the patients with abnormal post-PCI Pd/Pa ≤0.92 showed post-PCI FFR >0.80. Compared with post-PCI FFR, post-PCI Pd/Pa showed limited reclassification ability for the occurrence of TVF. Among patients with abnormal post-PCI Pd/Pa, only patients with positive post-PCI FFR showed significantly higher risk of TVF than did those with post-PCI Pd/Pa >0.92. (Prognostic Perspective of Invasive Hyperemic and Non-Hyperemic Physiologic Indices Measured After Percutaneous Coronary Intervention [PERSPECTIVEPCI]; NCT04265443).

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 23 Aug 2020; 13:1920-1933
Shin D, Lee SH, Lee JM, Choi KH, ... Shin ES, Doh JH
JACC Cardiovasc Interv: 23 Aug 2020; 13:1920-1933 | PMID: 32819481
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Abstract

Role of Teleproctoring in Challenging and Innovative Structural Interventions Amid the COVID-19 Pandemic and Beyond.

Goel SS, Greenbaum AB, Patel A, Little SH, ... Reardon MJ, Kleiman NS

Teleproctoring can be used successfully in performing challenging and innovative structural heart interventions using sophisticated technology that allows real-time bidirectional audiovisual communication with digital transmission of live videos and direct observation of the operative field by a remote proctor. The authors share an illustrative case that was performed amid the coronavirus disease-2019 global pandemic that led to travel restrictions to limit spread of the virus. Teleproctoring has future implications beyond the current global health crisis to facilitate rapid dissemination and exchange of knowledge for ultimately helping patients around the globe.

Copyright © 2020. Published by Elsevier Inc.

JACC Cardiovasc Interv: 23 Aug 2020; 13:1945-1948
Goel SS, Greenbaum AB, Patel A, Little SH, ... Reardon MJ, Kleiman NS
JACC Cardiovasc Interv: 23 Aug 2020; 13:1945-1948 | PMID: 32819483
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Abstract

Revascularization Deferral of Nonculprit Stenoses on the Basis of Fractional Flow Reserve: 1-Year Outcomes of 8,579 Patients.

Cerrato E, Mejía-Rentería H, Dehbi HM, Ahn JM, ... Park SJ, Escaned J
Objectives
The aim of this study was to evaluate the safety of revascularization deferral on the basis of fractional flow reserve interrogation of nonculprit lesions in patients with acute coronary syndromes (ACS).
Methods
A pooled analysis was performed of individual patient data included in 5 large international published studies on physiology-guided revascularization. The primary endpoint was major adverse cardiac events (MACE) (a composite of death, nonfatal myocardial infarction, or unplanned revascularization) at 1-year follow-up. Clinical outcomes of patients with ACS and stable angina pectoris (SAP) were compared in both the deferred and the revascularized groups.
Results
A total of 8,579 patients were included in the analysis, 6,461 with SAP and 2,118 with ACS and nonculprit lesions. Using fractional flow reserve, revascularization was deferred in 5,129 patients (59.8%) and performed in 3,450 patients (40.2%). In the deferred ACS group, a higher MACE rate was observed compared with the deferred SAP group (4.46% vs. 2.83%; adjusted hazard ratio [HR]: 1.72; 95% confidence interval [CI]: 1.17 to 2.53; p < 0.01). Both early unplanned revascularization (3.34% and 2.04% in ACS and SAP; adjusted HR: 1.81; 95% CI: 1.09 to 3.00; p = 0.02) and mortality (0.86 % and 0.56% in ACS and SAP; adjusted HR: 1.60; 95% CI: 0.68 to 3.79; p = 0.28) contributed to this excess in MACE. On the contrary, no differences in outcomes linked to clinical presentation were found in treated patients (MACE rate 6.51% vs. 6.20%; adjusted HR: 1.21; 95% CI: 0.88 to 1.26; p = 0.24).
Conclusions
Patients with ACS in whom revascularization of nonculprit lesions was deferred on the basis of fractional flow reserve have more MACE at 1 year compared with patients with SAP with deferred revascularization. Unplanned revascularization mainly contributed to this excess of MACE.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 23 Jul 2020; epub ahead of print
Cerrato E, Mejía-Rentería H, Dehbi HM, Ahn JM, ... Park SJ, Escaned J
JACC Cardiovasc Interv: 23 Jul 2020; epub ahead of print | PMID: 32739305
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Impact:
Abstract

Long-Term Outcomes of Coronary Stenting With and Without Use of Intravascular Ultrasound.

Mentias A, Sarrazin MV, Saad M, Panaich S, ... Horwitz PA, Girotra S
Objectives
This study sought to explore if intravascular ultrasound (IVUS) use in real-world patients is associated with improved long-term outcomes of percutaneous coronary intervention (PCI).
Background
The benefit of IVUS use with PCI in real world is uncertain.
Methods
We identified Medicare patients who underwent PCI from 2009 to 2017 and evaluated the association of IVUS use with long-term risk of mortality, myocardial infarction (MI), and repeat revascularization. We used propensity score matching and inverse probability weighting to adjust for baseline characteristics. To account for hospital effects, patients undergoing IVUS-guided PCI were matched to non-IVUS patients in the same hospital and year. Sensitivity analyses comparing outcomes with and without IVUS in stable coronary artery disease and acute coronary syndrome, PCI with bare-metal stents and drug-eluting stents, complex and noncomplex PCI, and facilities with 1% to 5%, 5% to 10%, and >10% IVUS use were performed.
Results
Overall, IVUS was used in 5.6% of all PCI patients (105,787 out of 1,877,177 patients). Patients with IVUS-guided PCI had a higher prevalence of most comorbidities. In the propensity matched analysis, IVUS-guided PCI was associated with lower 1-year mortality (11.5% vs. 12.3%), MI (4.9% vs. 5.2%), and repeat revascularization (6.1% vs. 6.7%) (p < 0.001 for all). In inverse probability weighting analysis with a median follow-up of 3.7 years (interquartile range: 1.7 to 6.4 years), IVUS-guided PCI was associated with a lower risk of mortality (adjusted hazard ratio [aHR]: 0.903; 95% confidence interval [CI]: 0.885 to 0.922), MI (aHR: 0.899; 95% CI: 0.893 to 0.904), and repeat revascularization (aHR: 0.893; 95% CI: 0.887 to 0.898) (p < 0.001 for all). These findings were consistent in all subgroups in sensitivity analyses.
Conclusions
In this contemporary U.S. Medicare cohort, the use of IVUS guidance in PCI remains low. Use of IVUS is associated with lower long-term mortality, MI, and repeat revascularization.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 23 Aug 2020; 13:1880-1890
Mentias A, Sarrazin MV, Saad M, Panaich S, ... Horwitz PA, Girotra S
JACC Cardiovasc Interv: 23 Aug 2020; 13:1880-1890 | PMID: 32819477
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Impact:
Abstract

Combination of F-ASO and Targeted Medical Therapy in Patients With Secundum ASD and Severe PAH.

Yan C, Pan X, Wan L, Li H, ... Wang L, Fang W
Objectives
This study was conducted to investigate the combined use of fenestrated atrial septal occluder (F-ASO) and targeted medical therapy (TMT) in patients with secundum atrial septal defect (ASD) and severe pulmonary arterial hypertension (PAH).
Background
Treatment of patients with ASD and severe PAH is still challenging.
Methods
After ethical approval was obtained, 56 consecutive patients with ASD with severe PAH were included (7 men, 49 women; median age 50.5 years; mean ASD size 26.9 ± 4.6 mm). After 3 months of TMT, transcatheter closure was performed using F-ASO in patients with ratios of pulmonary to systemic blood flow ≥1.5. TMT was continued post-operatively together with 6 months of dual-antiplatelet therapy. The hemodynamic variables during baseline, TMT alone, and combined treatment with F-ASO were compared.
Results
After only TMT, systolic pulmonary arterial pressure (-14.5 mm Hg; p < 0.001), pulmonary vascular resistance (-3.9 Wood units; p < 0.001), and exercise capacity (+72.0 m; p < 0.001) improved. Ratio of pulmonary to systemic blood flow increased by 0.9 (p < 0.001), with adverse cardiac remodeling (right ventricular dimension +3.5 mm; p < 0.001). Closure with F-ASO (median size 34.0 mm) led to further decrease in systolic pulmonary artery pressure (-6.0 mm Hg; p < 0.001). Follow-up (median duration 10 months) revealed further improvement in exercise capacity (+60.5 m; p < 0.001), with favorable cardiac remodeling (right ventricular dimension -9.9 mm; p < 0.001). In addition, all fenestrations were stable (p = 0.699), with negligible shunt (median ratio of pulmonary to systemic blood flow 1.1) and no complications. One year later, pulmonary artery pressure was normalized in 8 of 19 patients, and PAH recurred in 5 patients after discontinuation of TMT.
Conclusions
In patients with ASD and severe PAH, combination of F-ASO and TMT was a safe and effective procedure. Compared with TMT alone, the combined treatment further improved exercise capacity, with favorable cardiac remodeling.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 07 Aug 2020; epub ahead of print
Yan C, Pan X, Wan L, Li H, ... Wang L, Fang W
JACC Cardiovasc Interv: 07 Aug 2020; epub ahead of print | PMID: 32800498
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Impact:
Abstract

Long-Term Follow-Up in Patients With Stable Angina and Unobstructed Coronary Arteries Undergoing Intracoronary Acetylcholine Testing.

Seitz A, Gardezy J, Pirozzolo G, Probst S, ... Sechtem U, Ong P
Objectives
The aim of this study was to investigate the prognosis of a large cohort of patients with stable angina and unobstructed coronaries undergoing acetylcholine spasm testing.
Background
Coronary artery spasm can be found in up to 60% of patients with symptoms of myocardial ischemia despite unobstructed coronary arteries.
Methods
Consecutive symptomatic patients with unobstructed coronary arteries undergoing acetylcholine testing to detect epicardial or microvascular coronary spasm were prospectively enrolled. After a median follow-up period of 7.2 years (6.5 to 7.9 years), data regarding mortality, nonfatal myocardial infarction, stroke, repeat coronary angiography, recurrent symptoms, and quality of life were obtained in 736 patients (57% women, mean age 62 ± 12 years).
Results
In total, 55 deaths (7.5%), 8 nonfatal myocardial infarctions (1.4%), and 12 strokes (2.2%) occurred during the follow-up period. Recurrent symptoms were reported by 64% of patients, and repeat coronary angiography was performed in 12% of cases. Multivariate analysis revealed epicardial spasm as a predictor of nonfatal myocardial infarction (hazard ratio: 14.469; 95% confidence interval: 1.735 to 120.646) and repeat angiography (hazard ratio: 1.703; 95% confidence interval: 1.062 to 2.732), whereas patients with microvascular spasm more often had recurrent angina at follow-up (hazard ratio: 1.311; 95% confidence interval: 1.013 to 1.697).
Conclusions
In this long-term follow-up study, the overall prognosis of patients with coronary spasm was favorable. Patients with epicardial spasm were at increased risk for myocardial infarction and repeat angiography, while microvascular spasm was associated with recurrent angina. Acetylcholine testing may help identify patients at increased risk for adverse cardiac events among this overall low-risk population.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 23 Jul 2020; epub ahead of print
Seitz A, Gardezy J, Pirozzolo G, Probst S, ... Sechtem U, Ong P
JACC Cardiovasc Interv: 23 Jul 2020; epub ahead of print | PMID: 32739303
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Impact:
Abstract

Clinical Outcomes of On-Site Versus Off-Site Endovascular Stroke Interventions.

Alkhouli M, Alqahtani F, Hopkins LN, Harris AH, ... Tarabishy A, Holmes DR
Objectives
The aim of this study was to assess whether offering local endovascular stroke therapy (EST) rather than transferring patients off-site to receive EST would improve outcomes.
Background
There are limited data to determine whether offering EST on-site rather than transferring patients to receive EST off-site improves clinical outcomes.
Methods
A large academic consortium database was queried to identify patients with acute ischemic stroke who received EST between October 2015 and September 2019. Primary endpoints were in-hospital mortality and poor functional outcomes. Secondary endpoints were major complications, length of stay, and cost. Baseline characteristics were adjusted for using propensity score matching and multivariate risk adjustment.
Results
A total of 22,193 patients with acute ischemic stroke who underwent EST (50.8% on-site, 49.2% off-site) were included. Mean ages were 67.9 ± 15.5 years and 68.4 ± 15.5 years, respectively (p = 0.03). In the propensity score matching analysis, mortality and poor functional outcomes were higher in the off-site EST group (14.7% vs. 11.2% and 40.7% vs. 35.9%, respectively; p < 0.001). In the risk-adjusted analyses with different models, in-hospital mortality and poor functional outcomes remained significantly higher in the off-site EST group. In the most comprehensive model (adjusting for age, sex, demographics, risk factors, tissue plasminogen activator use, and institutional EST volume), in-hospital mortality and poor functional outcomes were significantly higher in the off-site EST group, with odds ratios of 1.38 (95% confidence interval: 1.26 to 1.51) and 1.26 (95% confidence interval: 1.18 to 1.34), respectively (p < 0.001). The incidence of intracranial hemorrhage and mechanical ventilation was higher in the off-site group, but cost was higher in the on-site group in both the propensity score matching and risk-adjusted analyses.
Conclusions
In contemporary U.S. practice, patients with acute ischemic stroke treated with EST on-site had lower in-hospital mortality and better functional outcomes compared with those transferred off-site for EST.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 20 Aug 2020; epub ahead of print
Alkhouli M, Alqahtani F, Hopkins LN, Harris AH, ... Tarabishy A, Holmes DR
JACC Cardiovasc Interv: 20 Aug 2020; epub ahead of print | PMID: 32861630
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Impact:
Abstract

1-Month Results From a Prospective Experience on CAS Using CGuard Stent System: The IRONGUARD 2 Study.

Sirignano P, Stabile E, Mansour W, Capoccia L, ... Ruggeri M, Speziale F
Objectives
The study sought to evaluate 30-day safety and efficacy of dual-layer mesh-covered carotid stent systems for carotid artery stenting (CAS) in the clinical practice.
Background
When compared with carotid endarterectomy, CAS has been associated with a higher rate of post procedural neurologic events; these could be related to plaque\'s debris prolapsing through stent\'s mesh. Consequently, the need for increased plaque coverage has resulted in the development of dual-layer mesh-covered carotid stent systems.
Methods
From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system in 20 centers. The primary endpoint was stroke up to 30 days; secondary endpoints were technical and procedural success; external carotid artery occlusion; and in-hospital and 30-day transient ischemic attack (TIA), acute myocardial infarction (AMI), and death rates.
Results
Symptoms were present in 131 (17.87%) patients. An embolic protection device was used in 731 (99.72%) patients. Procedural success was 100%, technical success was obtained in all but 1 (99.86%) patient, who died in hospital due to a hemorrhagic stroke. Six TIAs, 2 minor strokes, and 1 AMI occurred during in-hospital stay, and external carotid artery occlusion was evident in 8 (1.09%) patients. Between hospital discharge and 30-day follow-up, 2 TIAs, 1 minor stroke, and 3 AMIs occurred. Therefore, the cumulative stroke rate was 0.54%.
Conclusions
This real-world registry suggests that use of CGuard embolic prevention system in clinical practice is safe and associated with a minimal occurrence of adverse neurological events up to 30-day follow-up.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 20 Aug 2020; epub ahead of print
Sirignano P, Stabile E, Mansour W, Capoccia L, ... Ruggeri M, Speziale F
JACC Cardiovasc Interv: 20 Aug 2020; epub ahead of print | PMID: 32861633
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Impact:
Abstract

Transcatheter Aortic Valve Replacement for Residual Lesion of the Aortic Valve Following \"Healed\" Infective Endocarditis.

Santos-Martínez S, Alkhodair A, Nombela-Franco L, Saia F, ... San Román JA, Amat-Santos IJ
Objectives
This study aimed to evaluate the safety and mid-term efficacy of transcatheter aortic valve replacement (TAVR) in the setting of aortic valve (AV) infective endocarditis (IE) with residual lesion despite successful antibiotic treatment.
Background
Patients with AV-IE presenting residual lesion despite successful antibiotic treatment are often rejected for cardiac surgery due to high-risk. The use of TAVR following IE is not recommended.
Methods
This was a multicenter retrospective study across 10 centers, gathering baseline, in-hospital, and 1-year follow-up characteristics of patients with healed AV-IE treated with TAVR. Matched comparison according to sex, EuroSCORE, chronic kidney disease, left ventricular function, prosthesis type, and valve-in-valve procedure was performed with a cohort of patients free of prior IE treated with TAVR (46 pairs).
Results
Among 2,920 patients treated with TAVR, 54 (1.8%) presented with prior AV-IE with residual valvular lesion and healed infection. They had a higher rate of multivalvular disease and greater surgical risk scores. A previous valvular prosthesis was more frequent than a native valve (50% vs. 7.5%; p < 0.001). The in-hospital and 1-year mortality rates were 5.6% and 11.1%, respectively, comparable to the control cohort. After matching, the 1-year III to IV aortic regurgitation rate was 27.9% (vs. 10%; p = 0.08) and was independently associated with higher mortality. There was only 1 case of IE relapse (1.8%); however, 18% of patients were complicated with sepsis, and 43% were readmitted due to heart failure.
Conclusions
TAVR is a safe therapeutic alternative for residual valvular lesion after successfully healed AV-IE. At 1-year follow-up, the risk of IE relapse was low and mortality rate did not differ from TAVR patients free of prior IE, but one-fourth presented with significant aortic regurgitation and >50% required re-admission.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Sep 2020; 13:1983-1996
Santos-Martínez S, Alkhodair A, Nombela-Franco L, Saia F, ... San Román JA, Amat-Santos IJ
JACC Cardiovasc Interv: 13 Sep 2020; 13:1983-1996 | PMID: 32912458
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Impact:
Abstract

Incidence, Predictors, and Outcomes of Endocarditis After Transcatheter Aortic Valve Replacement in the United States.

Mentias A, Girotra S, Desai MY, Horwitz PA, ... Kapadia S, Sarrazin MV
Objectives
This study sought to evaluate the incidence and outcomes of endocarditis after transcatheter aortic valve replacement (TAVR).
Background
Data about endocarditis after TAVR are limited.
Methods
The study investigated Medicare patients who underwent TAVR from 2012 to 2017 and identified patients admitted with endocarditis during follow-up using a validated algorithm. The main study outcome was all-cause mortality.
Results
Of 134,717 patients who underwent TAVR, 1868 patients developed endocarditis during follow-up (incidence 0.87%/year), with majority of infections (65.0%) occurring within 1 year. Incidence of endocarditis declined in recent years. The most common organisms were Staphylococcus (22.0%), Streptococcus (20.0%), and Enterococcus (15.5%). Important predictors for endocarditis were younger age at TAVR, male sex, prior endocarditis, end-stage renal disease, repeat TAVR procedures, liver and lung disease, and post-TAVR acute kidney injury. Thirty-day and 1-year mortality were 18.5% and 45.6%, respectively. After adjusting for comorbidities and procedural complications, endocarditis after TAVR was associated with 3-fold higher risk of mortality (44.9 vs. 16.2 deaths per 100 person-years; adjusted hazard ratio [aHR]: 2.94; 95% confidence interval [CI]: 2.77 to 3.12; p < 0.0001). End-stage renal disease (aHR: 2.12; 95% CI: 1.72 to 2.60), endocarditis complicated by cardiogenic shock (aHR: 2.50, 95% CI: 1.56 to 4.02), ischemic stroke (aHR: 1.56; 95% CI: 1.07 to 2.28), intracerebral hemorrhage (aHR: 1.67; 95% CI: 1.01 to 2.76), acute kidney injury (aHR: 1.44; 95% CI: 1.27 to 1.63), blood transfusion (aHR: 1.28; 95% CI: 1.09 to 1.50), staphylococcal (aHR: 1.71; 95% CI: 1.49 to 1.97), and fungal endocarditis (aHR: 1.72; 95% CI: 1.23 to 2.39) (p < 0.05 for all) portended higher mortality following endocarditis.
Conclusions
The incidence of endocarditis after TAVR is low and declining. However, it is associated with poor prognosis with one-half the patients dying within 1 year.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Sep 2020; 13:1973-1982
Mentias A, Girotra S, Desai MY, Horwitz PA, ... Kapadia S, Sarrazin MV
JACC Cardiovasc Interv: 13 Sep 2020; 13:1973-1982 | PMID: 32912457
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Impact:
Abstract

Impact of Massive or Torrential Tricuspid Regurgitation in Patients Undergoing Transcatheter Tricuspid Valve Intervention.

Miura M, Alessandrini H, Alkhodair A, Attinger-Toller A, ... Taramasso M,
Objectives
The aim of this study was to assess the clinical outcome of baseline massive or torrential tricuspid regurgitation (TR) after transcatheter tricuspid valve intervention (TTVI).
Background
The use of TTVI to treat symptomatic severe TR has been increasing rapidly, but little is known regarding the impact of massive or torrential TR beyond severe TR.
Methods
The study population comprised 333 patients with significant symptomatic TR from the TriValve Registry who underwent TTVI. Mid-term outcomes after TTVI were assessed according to the presence of massive or torrential TR, defined as vena contracta width ≥14 mm. Procedural success was defined as patient survival after successful device implantation and delivery system retrieval, with residual TR ≤2+. The primary endpoint comprised survival rate and freedom from rehospitalization for heart failure, survival rate, and rehospitalization at 1 year.
Results
Baseline massive or torrential TR and severe TR were observed in 154 patients (46.2%) and 179 patients (53.8%), respectively. Patients with massive or torrential TR had a higher prevalence of ascites than those with severe TR (27.3% vs. 20.4%, respectively; p = 0.15) and demonstrated a similar procedural success rate (83.2% vs. 77.3%, respectively; p = 0.21). The incidence of peri-procedural adverse events was low, with no significant between-group differences. Freedom from the composite endpoint was significantly lower in patients with massive or torrential TR than in those with severe TR, which was significantly associated with an increased risk for 1-year death of any cause or rehospitalization for heart failure (adjusted hazard ratio: 1.91; 95% confidence interval: 1.10 to 3.34; p = 0.022). Freedom from the composite endpoint was significantly higher in patients with massive or torrential TR when procedural success was achieved (69.9% vs. 54.2%, p = 0.048).
Conclusions
Baseline massive or torrential TR is associated with an increased risk for all-cause mortality and rehospitalization for heart failure 1 year after TTVI. Procedural success is related to better outcomes, even in the presence of baseline massive or torrential TR. (International Multisite Transcatheter Tricuspid Valve Therapies Registry [TriValve]; NCT03416166).

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Sep 2020; 13:1999-2009
Miura M, Alessandrini H, Alkhodair A, Attinger-Toller A, ... Taramasso M,
JACC Cardiovasc Interv: 13 Sep 2020; 13:1999-2009 | PMID: 32912460
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Impact:
Abstract

Left Ventricular End-Diastolic Pressure Versus Urine Flow Rate-Guided Hydration in Preventing Contrast-Associated Acute Kidney Injury.

Briguori C, D\'Amore C, De Micco F, Signore N, ... Signoriello G, Focaccio A
Objectives
This study compared left ventricular end-diastolic pressure (LVEDP)-guided and urine flow rate (UFR)-guided hydration.
Background
Tailored hydration regimens improve the prevention of contrast-associated acute kidney injury (CA-AKI).
Methods
Between July 15, 2015, and June 6, 2019, patients at high risk for CA-AKI scheduled for coronary and peripheral procedures were randomized to 2 groups: 1) normal saline infusion rate adjusted according to the LVEDP (LVEDP-guided group); and 2) hydration controlled by the RenalGuard System in order to reach UFR ≥300 ml/h (UFR-guided group). The primary endpoint was the composite of CA-AKI (i.e., serum creatinine increase ≥25% or ≥0.5 mg/dl at 48 h) and acute pulmonary edema (PE). Major adverse events (all-cause death, renal failure requiring dialysis, PE, and sustained kidney injury) at 1 month were assessed.
Results
The primary endpoint occurred in 20 of 351 (5.7%) patients in the UFR-guided group and in 36 of 351 (10.3%) patients in the LVEDP-guided group (relative risk [RR]: 0.560; 95% confidence interval [CI]: 0.390 to 0.790; p = 0.036). CA-AKI and PE rates in the UFR-guided group and LVEDP-guided group were 5.7% and 10.0% (RR: 0.570; 95% CI: 0.300 to 0.960; p = 0.048), and, respectively, 0.3% and 2.0% (RR: 0.070; 95% CI: 0.020 to 1.160; p = 0.069). Three patients in the UFR-guided group experienced complications related to the Foley catheter. Hypokalemia rate was 6.2% in the UFR-guided group and 2.3% in the LVEDP-guided group (p = 0.013). The 1-month major adverse events rate was 7.1% in the UFR-guided group and 12.0% in the LVEDP-guided group (p = 0.030).
Conclusions
The study demonstrates that UFR-guided hydration is superior to LVEDP-guided hydration to prevent the composite of CA-AKI and PE.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Sep 2020; 13:2065-2074
Briguori C, D'Amore C, De Micco F, Signore N, ... Signoriello G, Focaccio A
JACC Cardiovasc Interv: 13 Sep 2020; 13:2065-2074 | PMID: 32912462
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Impact:
Abstract

Left Ventricular Remodeling After Transcatheter Mitral Valve Replacement With Tendyne: New Insights From Computed Tomography.

Fukui M, Sorajja P, Gössl M, Bae R, ... Muller D, Cavalcante JL
Objectives
The aim of this study was to describe the anatomic and functional changes in left-sided chambers using computed tomographic angiography (CTA) from baseline to 1 month after transcatheter mitral valve replacement (TMVR) with the Tendyne prosthesis.
Background
Data on changes in left atrial and left ventricular (LV) volumes after TMVR implantation are very limited.
Methods
Patients who underwent TMVR with the Tendyne prosthesis between 2015 and 2018 were analyzed. Changes in LV end-diastolic volume, ejection fraction, LV mass, left atrial volume, and global longitudinal strain were assessed at baseline and 1 month after TMVR using CTA. Specific Tendyne implant characteristics were identified and correlated with remodeling changes.
Results
A total of 36 patients (median age 74 years; interquartile range [IQR]: 69 to 78 years; 78% men; 86% with secondary mitral regurgitation) were included in this study. There were significant decreases in LV end-diastolic volume (281 ml [IQR: 210 to 317 ml] vs. 239 ml [IQR: 195 to 291 ml]; p < 0.001), LV ejection fraction (37% [IQR: 31% to 48%] vs. 30% [IQR: 23% to 40%]; p < 0.001), LV mass (126 g [IQR: 96 to 155 g] vs. 116 g [IQR: 92 to 140 g]; p < 0.001), left atrial volume (171 ml [IQR: 133 to 216 ml] vs. 159 ml [IQR: 125 to 201 ml]; p = 0.027), and global longitudinal strain (-11% [IQR: -17% to -8%] vs. -9% [IQR: -12% to -6%]; p < 0.001) from baseline to 1-month follow-up. Favorable LV end-diastolic volume reverse remodeling occurred in the majority (30 of 36 patients [83%]). Closer proximity of the Tendyne apical pad to the true apex (24 mm [IQR: 21 to 29 mm] vs. 35 mm [IQR: 26 to 40 mm]) was predictive of favorable remodeling (p = 0.037).
Conclusions
TMVR with Tendyne results in favorable left-sided chamber remodeling in the majority of patients treated, as detected on CTA at 1 month after implantation. CTA identifies favorable post-TMVR changes, which could be related to specific characteristics of the device implantation.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 18 Aug 2020; epub ahead of print
Fukui M, Sorajja P, Gössl M, Bae R, ... Muller D, Cavalcante JL
JACC Cardiovasc Interv: 18 Aug 2020; epub ahead of print | PMID: 32868218
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Impact:
Abstract

Aspirin-Free Prasugrel Monotherapy Following Coronary Artery Stenting in Patients With Stable CAD: The ASET Pilot Study.

Kogame N, Guimarães PO, Modolo R, De Martino F, ... Serruys PW, Lemos PA
Objectives
The aim of this study was to evaluate the hypothesis that prasugrel monotherapy following successful everolimus-eluting stent implantation is feasible and safe in patients with stable coronary artery disease (CAD).
Background
Recent studies have suggested that short dual-antiplatelet therapy strategies may provide an adequate balance between ischemic and bleeding risks. However, the complete omission of aspirin immediately after percutaneous coronary intervention (PCI) has not been tested so far.
Methods
The study was a multicenter, single-arm, open-label trial with a stopping rule based on the occurrence of definite stent thrombosis (if >3, trial enrollment would be terminated). Patients undergoing successful everolimus-eluting stent implantation for stable CAD with SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) scores <23 were included. All participants were on standard dual-antiplatelet therapy at the time of index PCI. Aspirin was discontinued on the day of the index procedure but given prior to the procedure; prasugrel was administered in the catheterization laboratory immediately after the successful procedure, and aspirin-free prasugrel became the therapy regimen from that moment. Patients were treated solely with prasugrel for 3 months. The primary ischemic endpoint was the composite of cardiac death, spontaneous target vessel myocardial infarction, or definite stent thrombosis, and the primary bleeding endpoint was Bleeding Academic Research Consortium types 3 and 5 bleeding up to 3 months.
Results
From February 22, 2018, to May 7, 2019, 201 patients were enrolled. All patients underwent PCI for stable CAD. Overall, 98.5% of patients were adherent to prasugrel at 3-month follow-up. The primary ischemic and bleeding endpoints occurred in 1 patient (0.5%). No stent thrombosis events occurred.
Conclusions
Aspirin-free prasugrel monotherapy following successful everolimus-eluting stent implantation demonstrated feasibility and safety without any stent thrombosis in selected low-risk patients with stable CAD. These findings may help underpin larger randomized controlled studies to evaluate the aspirin-free strategy compared with traditional dual-antiplatelet therapy following PCI. (Acetyl Salicylic Elimination Trial: The ASET Pilot Study [ASET]; NCT03469856).

Copyright © 2020. Published by Elsevier Inc.

JACC Cardiovasc Interv: 10 Sep 2020; epub ahead of print
Kogame N, Guimarães PO, Modolo R, De Martino F, ... Serruys PW, Lemos PA
JACC Cardiovasc Interv: 10 Sep 2020; epub ahead of print | PMID: 32950419
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Impact:
Abstract

Randomized Controlled Trial of Acotec Drug-Eluting Balloon Versus Plain Balloon for Below-the-Knee Angioplasty.

Liistro F, Angioli P, Ventoruzzo G, Ducci K, ... Pieroni M, Bolognese L
Objectives
The aim of this study was to investigate the efficacy and safety of the Litos drug-coated balloon (DCB) versus plain old balloon angioplasty (POBA) for reduction of late lumen loss (LLL) in patients with critical limb ischemia undergoing below-the-knee (BTK) intervention.
Background
Restenosis after balloon angioplasty of BTK arteries approximates 70%. Previous studies of DCBs in BTK arteries produced conflicting results.
Methods
ACOART-BTK (Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos® in Below-the-Knee Arteries to Treat Critical Limb Ischemia) is a randomized controlled single-center study. Inclusion criteria were critical limb ischemia (Rutherford class ≥4) and significant stenosis or occlusion >40 mm of at least 1 BTK vessel with distal runoff successfully treated with angioplasty. Six-month angiographic LLL was the primary endpoint. Occlusive restenosis at 6 months and clinically driven target lesion revascularization at 12 months were secondary endpoints.
Results
From January 2016 through January 2019, 105 patients with 129 BTK lesions were enrolled in the study. Mean lesion length was 168 ± 109 mm in the DCB group and 187 ± 113 mm in the POBA group (p = 0.30). Almost 70% of lesions were occluded at baseline in both groups. On 6-month angiography, mean LLL was 0.51 ± 0.60 mm in the DCB group and 1.31 ± 0.72 mm in the POBA group (p < 0.001); rates of occlusive restenosis were 8.6% and 48.4%, respectively (p < 0.001). Twelve-month clinically driven target lesion revascularization occurred in 6 of 62 DCB-treated lesions (10%) versus 27 of 66 POBA-treated lesions (41%) (p < 0.001). Complete healing at 12 months was observed in 42 of 47 DCB-treated limbs (89.4) versus 35 of 47 POBA-treated limbs (74.5%) (p = 0.05); no major amputations occurred.
Conclusions
Litos DCBs strikingly reduced LLL, vessel reocclusion, and clinically driven target lesion revascularization compared with POBA in BTK angioplasty.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Sep 2020; epub ahead of print
Liistro F, Angioli P, Ventoruzzo G, Ducci K, ... Pieroni M, Bolognese L
JACC Cardiovasc Interv: 10 Sep 2020; epub ahead of print | PMID: 32950416
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Impact:
Abstract

Real-World Experience With a Paclitaxel-Coated Balloon in Critical Limb Ischemia: 24-Month Subgroup Outcomes of BIOLUX P-III.

Brodmann M, Moscovic M, Wang JCC, Nano G, ... Corpataux JM, Tepe G
Objectives
The aim of the BIOLUX P-III (A Prospective, International, Multi-Centre, Post-Market All-Comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries - III) registry was to collect real-world data on the Passeo-18 Lux paclitaxel-coated balloon.
Background
Critical limb ischemia (CLI) is a severe condition associated with high morbidity and mortality. Prospective data are needed to provide further insights on drug-eluting devices.
Methods
BIOLUX P-III is a prospective, post-market, all-comers registry assessing the safety and performance of the Passeo-18 Lux. Clinical information was collected at 6, 12, and 24 months. The authors report 24-month outcomes of the CLI subgroup with patients in Rutherford classes 4 to 6.
Results
The CLI subgroup included 328 patients with 422 lesions. Patients were 71.1 ± 10.5 years of age, and 61.0% had diabetes. Femoropopliteal lesions were present in 53.8% (n = 227), below-the-knee lesions were present in 27.0% (n = 114), and lesions were moderate or heavily calcified in 45.0% (n = 190). Major adverse events, defined as 30-day device- or procedure-related mortality, major target limb amputation, and clinically driven target lesion revascularization, occurred in 9.8% of patients through 6 months, in 14.9% through 12 months, and in 19.4% through 24 months. Clinically driven target lesion revascularization occurred in 4.4%, 8.5%, and 12.1%, major amputation in 4.9%, 5.2%, and 6.1%, and mortality in 8.1%, 11.1%, and 20.1%, respectively. Predictors of mortality were age ≥75 years and higher Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease class, and higher Rutherford class was associated with increased mortality and amputation rates.
Conclusions
In a large, multimorbid patient population with complex lesions and CLI, the safety and performance of the Passeo-18 Lux paclitaxel-coated balloon has been confirmed, with low rates of major amputation and target lesion revascularization.

Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Sep 2020; epub ahead of print
Brodmann M, Moscovic M, Wang JCC, Nano G, ... Corpataux JM, Tepe G
JACC Cardiovasc Interv: 10 Sep 2020; epub ahead of print | PMID: 32950415
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Abstract

Valvular and Nonvalvular Atrial Fibrillation in Patients Undergoing Transcatheter Aortic Valve Replacement.

Okuno T, Hagemeyer D, Brugger N, Ryffel C, ... Windecker S, Pilgrim T
Objectives
The aim of this study was to investigate the impact of valvular and nonvalvular atrial fibrillation (AF) in patients undergoing transcatheter aortic valve replacement (TAVR).
Background
AF has been associated with adverse clinical outcomes after TAVR. However, the differential impact of valvular as opposed to nonvalvular AF has not been investigated.
Methods
In a retrospective analysis of a prospective registry, valvular AF was defined as AF in the setting of concomitant mitral stenosis or the presence of a mitral valve prosthesis. The presence of mitral stenosis was determined by pre-procedural echocardiography. The primary endpoint was a composite of cardiovascular death or disabling stroke at 1 year after TAVR.
Results
Among 1,472 patients undergoing TAVR between August 2007 and June 2018, AF was recorded in 465 patients (31.6%) and categorized as nonvalvular in 376 (25.5%) and valvular in 89 (6.0%). AF scores including HAS-BLED, CHADS, and CHADS-VASc were comparable between patients with nonvalvular and valvular AF. The primary endpoint occurred in 9.3% of patients with no AF, in 14.5% of patients with nonvalvular AF (hazard ratio: 1.57; 95% confidence interval: 1.12 to 2.20; p = 0.009), and in 24.2% of patients with valvular AF (hazard ratio: 2.75; 95% confidence interval: 1.71 to 4.41; p < 0.001). Valvular AF conferred an increased risk for cardiovascular death or disabling stroke compared with nonvalvular AF (hazard ratio: 1.77; 95% confidence interval: 1.07 to 2.94; p = 0.027).
Conclusions
The presence of valvular AF in patients undergoing TAVR increased the risk for cardiovascular death or disabling stroke compared with both no AF and nonvalvular AF. (SWISS TAVI Registry; NCT01368250).

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 27 Sep 2020; 13:2124-2133
Okuno T, Hagemeyer D, Brugger N, Ryffel C, ... Windecker S, Pilgrim T
JACC Cardiovasc Interv: 27 Sep 2020; 13:2124-2133 | PMID: 32972574
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Impact:
Abstract

Effect of Ticagrelor on Left Ventricular Remodeling in Patients With ST-Segment Elevation Myocardial Infarction (HEALING-AMI).

Park Y, Koh JS, Lee JH, Park JH, ... Jeong YH,
Objectives
The aim of this study was to evaluate the effect of ticagrelor versus clopidogrel on left ventricular (LV) remodeling after reperfusion of ST-segment elevation myocardial infarction (STEMI) in humans.
Background
Animal studies have demonstrated that ticagrelor compared with clopidogrel better protects myocardium against reperfusion injury and improves remodeling after myocardial infarction.
Methods
In this investigator-initiated, randomized, open-label, assessor-blinded trial performed at 10 centers in Korea, patients were enrolled if they had naive STEMI successfully treated with primary percutaneous coronary intervention (PCI) and at least 6-month planned duration of dual-antiplatelet treatment. The coprimary endpoints were LV remodeling index (LVRI) (a relative change of LV end-diastolic volume) measured on 3-dimensional echocardiography and N-terminal pro-B-type natriuretic peptide level at 6 months.
Results
Among initially enrolled patients with STEMI (n = 336), 139 in each group completed the study. LVRI at 6 months was numerically lower with ticagrelor versus clopidogrel (0.6 ± 18.6% vs. 4.5 ± 16.5%; p = 0.095). Ticagrelor significantly reduced the 6-month level of N-terminal pro-B-type natriuretic peptide (173 ± 141 pg/ml vs. 289 ± 585 pg/ml; p = 0.028). These differences were prominent in patients with pre-PCI TIMI (Thrombolysis In Myocardial Infarction) flow grade 0. By multivariate analysis, ticagrelor versus clopidogrel reduced the risk for positive LV remodeling (LVRI >0%) (odds ratio: 0.56; 95% confidence interval: 0.33 to 0.95; p = 0.030). The LV end-diastolic volume index remained unchanged during ticagrelor treatment (from 54.7 ± 12.2 to 54.2 ± 12.2 ml/m; p = 0.629), but this value increased over time during clopidogrel treatment (from 54.6 ± 11.3 to 56.4 ± 13.9 ml/m; p = 0.056) (difference -2.3 ml/m; 95% confidence interval: -4.8 to 0.2 ml/m; p = 0.073). Ticagrelor reduced LV end-systolic volume index (from 27.0 ± 8.5 to 24.7 ± 8.4 ml/m; p < 0.001), whereas no reduction was seen with clopidogrel (from 26.2 ± 8.9 to 25.6 ± 11.0 ml/m; p = 0.366) (difference -1.8 ml/m; 95% confidence interval: -3.5 to -0.1 ml/m; p = 0.040).
Conclusions
Ticagrelor was superior to clopidogrel for LV remodeling after reperfusion of STEMI with primary PCI. (High Platelet Inhibition With Ticagrelor to Improve Left Ventricular Remodeling in Patients With ST Segment Elevation Myocardial Infarction [HEALING-AMI]; NCT02224534).

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Oct 2020; 13:2220-2234
Park Y, Koh JS, Lee JH, Park JH, ... Jeong YH,
JACC Cardiovasc Interv: 11 Oct 2020; 13:2220-2234 | PMID: 33032710
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Abstract

Ischemic Stroke With Cerebral Protection System During Transcatheter Aortic Valve Replacement.

Megaly M, Sorajja P, Cavalcante JL, Pershad A, ... Elbadawi A, Garcia S
Objectives
The objective of this study was to evaluate in-hospital outcomes with use of the Sentinel cerebral protection system (CPS) in transcatheter aortic valve replacement (TAVR).
Background
The role of the Sentinel CPS in preventing clinical ischemic stroke has been controversial.
Methods
The Nationwide Inpatient Sample database from the last three quarters of 2017, after the approval of the Sentinel CPS device, was queried to identify hospitalizations for TAVR. A 1:2 propensity score-matched analysis to compare in-hospital outcomes with versus without use of the CPS. The primary outcome was the occurrence of ischemic strokes.
Results
A total of 36,220 weighted discharges of patients who underwent TAVR (525 with the CPS and 35,695 without) were identified. The overall percentages of ischemic and hemorrhagic strokes were 2.4% and 0.2%, respectively. After propensity score matching (525 CPS, 1,050 no CPS), the risk for ischemic stroke was lower with use of the CPS (1 % vs. 3.8%, odd ratio [OR]: 0.243 (95% confidence interval: 0.095 to 0.619); p = 0.003). The cost of the index hospitalization was higher with use of the CPS ($47,783 vs. $44,578; p = 0.002). In multivariate regression analysis, use of the CPS was independently associated with a lower risk for ischemic stroke (OR: 0.380; 95% confidence interval: 0.157 to 0.992; p = 0.032).
Conclusions
Use of the Sentinel CPS in patients undergoing TAVR is associated with a lower incidence of ischemic stroke and in-hospital mortality, without an increased risk for procedural complications but with an increased cost of the index hospitalization.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 27 Sep 2020; 13:2149-2155
Megaly M, Sorajja P, Cavalcante JL, Pershad A, ... Elbadawi A, Garcia S
JACC Cardiovasc Interv: 27 Sep 2020; 13:2149-2155 | PMID: 32972578
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Impact:
Abstract

Impact of Coronary Artery Disease on Outcomes in Patients Undergoing Percutaneous Edge-to-Edge Repair.

Shamekhi J, Weber M, Sugiura A, Öztürk C, ... Nickenig G, Sinning JM
Objectives
The aim of this observational study was to evaluate the impact of concomitant coronary artery disease (CAD) on outcomes in patients undergoing percutaneous valve repair with the MitraClip system.
Background
Mitral valve regurgitation and CAD are often coexistent in elderly patients undergoing percutaneous mitral valve repair. The impact of CAD and revascularization on outcomes in this patient cohort, however, remains uncertain.
Methods
In 444 MitraClip patients, CAD severity was assessed, represented by the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS), as well as the residual SS (rSS) and SYNTAX score II (SS-II). Patients were stratified according to CAD severity and SS-II values (SS ≤3 vs. SS >3 and SS-II ≤45 vs. SS-II >45) and according to remaining CAD burden into 2 groups (rSS = 0 vs. rSS >0) to compare 1-year all-cause mortality.
Results
Higher SS, rSS, and SS-II were associated with mortality (22% for SS >3 vs. 9.6% for SS ≤3 [p < 0.001], 31.4% for rSS >0 vs. 9.6% for rSS = 0 [p < 0.001], and 17.1% for SS-II > 45 vs. 11.2% for SS-II ≤45 [p = 0.044]). The rSS was an independent predictor of 1-year all-cause mortality (p = 0.001) in multivariate analysis.
Conclusions
The complexity of CAD, as assessed using the SS, is associated with outcomes in patients undergoing MitraClip procedures. The burden of residual CAD after percutaneous coronary intervention is an independent predictor of 1-year all-cause mortality. Patients undergoing complete revascularization had the most favorable outcomes independent of mitral regurgitation etiology.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 27 Sep 2020; 13:2137-2145
Shamekhi J, Weber M, Sugiura A, Öztürk C, ... Nickenig G, Sinning JM
JACC Cardiovasc Interv: 27 Sep 2020; 13:2137-2145 | PMID: 32972576
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Impact:
Abstract

Predictors of Residual Right-to-Left Shunt After Percutaneous Suture-Mediated Patent Fossa Ovalis Closure.

Gaspardone A, Sgueglia GA, De Santis A, D\'Ascoli E, ... Gaspardone C, Versaci F
Objectives
This study sought to assess patent fossa ovalis (PFO) anatomy by transesophageal echocardiography (TEE) in patients undergoing percutaneous suture-mediated PFO closure to identify predictors of post-procedural residual atrial right-to-left shunt (RLS).
Background
Percutaneous suture-mediated PFO closure has been proven to be a safe and effective technique in most PFO patients.
Methods
From June 2016 to October 2019, 247 consecutive patients underwent percutaneous suture-mediated PFO closure at our institution. Of them, 230 (46 ± 13 years of age, 146 women) had complete and technically evaluable pre-procedural TEE. The following parameters in short-axis view were assessed: presence and grade of spontaneous RLS, PFO length and width, presence of atrial septal aneurysm and its maximal bulge, and presence of an embryonic or fetal remnant (Chiari network or Eustachian valve).
Results
At the first follow-up transthoracic echocardiography performed between 3 and 6 months from the closure procedure, a residual RLS ≥2 grade was found in 37 (16%) patients. Grade of pre-procedural spontaneous RLS (hazard ratio: 1.99; 95% confidence interval: 1.14 to 3.48; p = 0.016) shunt and PFO width (hazard ratio: 2.52; 95% confidence interval: 1.85 to 3.43; p < 0.001) were both found to be significantly associated with significant residual RLS at multivariable analysis. The presence of atrial septal aneurysm and its maximal bulge and of congenital remnants was not associated with significant residual RLS.
Conclusions
Percutaneous suture-mediated PFO closure is feasible in the majority of septal anatomies; however, PFO >5 mm in width and spontaneous large RLS are less likely to be closed with 1 stitch only.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 27 Sep 2020; 13:2112-2120
Gaspardone A, Sgueglia GA, De Santis A, D'Ascoli E, ... Gaspardone C, Versaci F
JACC Cardiovasc Interv: 27 Sep 2020; 13:2112-2120 | PMID: 32972572
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Impact:
Abstract

The Impact of CHADS-VASc and HAS-BLED Scores on Clinical Outcomes in the Amplatzer Amulet Study.

Tarantini G, D\'Amico G, Schmidt B, Mazzone P, ... Odenstedt J, Nielsen-Kudsk JE
Objectives
The aim of this study was to evaluate the impact of CHADS-VASc and HAS-BLED scores on ischemic and bleeding events of patients enrolled in the Amplatzer Amulet Observational Study.
Background
Baseline CHADS-VASc and HAS-BLED scores have been validated in atrial fibrillation patients to guide about anticoagulation but not in patients treated by left atrial appendage occlusion (LAAO).
Methods
Subjects were stratified according to CHADS-VASc and HAS-BLED scores. Clinical outcomes were collected through 2 years and adjudicated by an independent committee.
Results
Subjects were considered at low (n = 156), moderate (n = 715), and high (n = 215) risk for ischemic stroke, corresponding to CHADS-VASc scores of <3, 3 to 5, and ≥6, respectively. The annual rates of ischemic stroke were 1.1%, 2.0%, and 3.5%, respectively. When compared with the predicted rate, LAAO reduced the risk of ischemic stroke by 56%, 69%, and 68%. Device-related thrombus occurred in 0.7%, 1.5%, and 3.0% of subjects at low, moderate, and high risk for ischemic stroke, respectively. The HAS-BLED score was ≤3 in 629 subjects and >3 in 456 subjects, respectively. Non-peri-procedural major bleeding was reduced by 11% and 9% compared with predicted rates in the low and high bleeding risk groups, respectively.
Conclusions
LAAO with the Amplatzer Amulet reduced the risk of ischemic stroke compared with the predicted rate, with a greater magnitude among patients at high thromboembolic risk without increasing the bleeding risk. (Amplatzer™Amulet™ Post-Market Study [Amulet™PMS]; NCT02447081).

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 27 Sep 2020; 13:2099-2108
Tarantini G, D'Amico G, Schmidt B, Mazzone P, ... Odenstedt J, Nielsen-Kudsk JE
JACC Cardiovasc Interv: 27 Sep 2020; 13:2099-2108 | PMID: 32972570
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Impact:
Abstract

First-in-Human Transcatheter Tricuspid Valve Repair: 30-Day Follow-Up Experience With the Mistral Device.

Planer D, Beeri R, Danenberg HD
Objectives
This study sought to report short-term results of safety, performance, and efficacy of the Mistral device first-in-human study in patients suffering from severe functional tricuspid insufficiency.
Background
Patients who suffer from severe tricuspid regurgitation (TR) and who are at high surgical risk have no standard care therapy. Therefore, minimally invasive and safer methods are sought. The Mistral device is an investigational spiral-shaped device intended for percutaneous transcatheter repair. The Mistral device approximates the tricuspid leaflets by grasping together the chordae tendineae of the tricuspid valve.
Methods
Seven patients (4 women; mean age 73.14 ± 7.4 years) with severe (n = 5) and massive (n = 2) symptomatic TR and high surgical risk underwent Mistral tricuspid repair under transesophageal echocardiography guidance.
Results
Mistral was successfully implanted in all cases with a single device deployed in 6 patients, with 2 devices deployed in 1 patient. No procedural or 30-day adverse events occurred. TR was reduced by at least 1 grade in all patients. Effective regurgitant orifice area was reduced from median 0.52 cm (interquartile range [IQR]: 0.40 to 0.60 cm) at baseline to 0.15 cm (IQR: 0.14 to 0.21 cm) at 30 days post-procedure (p < 0.01), vena contracta width was reduced from 0.95 cm (IQR: 0.81 to 1.16 cm) to 0.62 cm (IQR: 0.52 to 0.67 cm) (p < 0.05), and regurgitant volume decreased from 49.4 ml/beat (IQR: 45.2 to 57.7 ml/beat) to 19.7 ml/beat (IQR: 12.4 to 23.9 ml/beat) (p < 0.01). Right ventricular fractional area change improved from 27.0% (IQR: 21.3% to 33.5%) at baseline to 38.5% (IQR: 29.0% to 47.1%) at 30-day follow-up (p < 0.05). Significant improvements in New York Heart Association functional class, Kansas City Cardiomyopathy Questionnaire score, and 6-min walk test were observed at 30 days.
Conclusions
Tricuspid valve repair with the Mistral device appears safe and leads to 30-day reduction of tricuspid insufficiency and improvement of right ventricular function and exercise capacity.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 27 Sep 2020; 13:2091-2096
Planer D, Beeri R, Danenberg HD
JACC Cardiovasc Interv: 27 Sep 2020; 13:2091-2096 | PMID: 32972568
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Abstract

Ticagrelor or Prasugrel in Patients With Acute Coronary Syndromes and Diabetes Mellitus.

Ndrepepa G, Kastrati A, Menichelli M, Neumann FJ, ... Schüpke S, Mayer K
Objectives
The aim of this study was to assess the efficacy and safety of ticagrelor versus prasugrel in patients with diabetes mellitus (DM) presenting with acute coronary syndromes (ACS) in whom invasive therapy was planned.
Background
The efficacy and safety of ticagrelor versus prasugrel in patients with ACS with DM undergoing invasive treatment remain unknown.
Methods
This pre-specified analysis of the ISAR-REACT (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment) 5 trial included 892 patients with ACS with DM and 3,124 patients with ACS without DM randomized to prasugrel or ticagrelor. The primary endpoint was a composite of death, myocardial infarction, or stroke; the safety endpoint was Bleeding Academic Research Consortium types 3 to 5 bleeding (both assessed 12 months after randomization).
Results
The primary endpoint occurred in 51 patients (11.2%) in the ticagrelor group and 55 patients (13.0%) in the prasugrel group in the DM cohort (hazard ratio: 0.84; 95% confidence interval: 0.58 to 1.24; p = 0.383) and in 132 patients (8.6%) in the ticagrelor group and 81 patients (5.2%) in the prasugrel group in the non-DM cohort (hazard ratio: 1.70; 95% confidence interval: 1.29 to 2.24; p < 0.001). There was a significant treatment arm-by-diabetic status interaction (p = 0.0035). Bleeding Academic Research Consortium types 3 to 5 bleeding occurred in 27 patients (6.9%) in the ticagrelor group and 19 patients (5.5%) in the prasugrel group (p = 0.425) in the DM cohort and in 68 patients (5.2%) in the ticagrelor group and 60 patients (4.6%) in the prasugrel group in the non-DM cohort (p = 0.500).
Conclusions
DM seems to affect the efficacy of ticagrelor and prasugrel in patients with ACS. In patients with DM, the efficacy of ticagrelor was comparable with that of prasugrel. (Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome [ISAR-REACT 5]; NCT01944800).

Copyright © 2020. Published by Elsevier Inc.

JACC Cardiovasc Interv: 11 Oct 2020; 13:2238-2247
Ndrepepa G, Kastrati A, Menichelli M, Neumann FJ, ... Schüpke S, Mayer K
JACC Cardiovasc Interv: 11 Oct 2020; 13:2238-2247 | PMID: 33032712
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Impact:
Abstract

Coronary Angiography in Patients With Out-of-Hospital Cardiac Arrest Without ST-Segment Elevation: A Systematic Review and Meta-Analysis.

Verma BR, Sharma V, Shekhar S, Kaur M, ... Reed G, Kapadia S
Objectives
The authors conducted a meta-analysis to study clinical outcomes in patients who underwent early versus nonearly coronary angiography (CAG) in the setting of out-of-hospital cardiac arrest (OHCA) without ST-segment elevation.
Background
The benefit of performing early CAG in patients with OHCA without STE remains disputed.
Methods
MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were searched according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines from inception until February 21, 2020. Early and nonearly CAG patients were identified on the basis of the definitions mentioned in respective published studies. The primary outcome studied was 30-day mortality. Secondary outcomes were neurological status and the rate of percutaneous coronary intervention (PCI) following cardiac arrest.
Results
Of 4,516 references, 11 studies enrolling 3,581 patients were included in the final meta-analysis. Random-effects analysis showed no differences in 30-day mortality (risk ratio [RR]: 0.86; 95% confidence interval [CI]: 0.71 to 1.04; p = 0.12; I = 74%), neurological status (RR: 1.08; 95% CI: 0.94 to 1.24; p = 0.28; I = 69%), and rate of PCI (RR: 1.22; 95% CI: 0.94 to 1.59; p = 0.13; I = 67%) between the 2 groups. Diabetes mellitus, chronic renal failure, previous PCI, and lactate level were found to be significant predictors of 30-day mortality on meta-regression (p < 0.05).
Conclusions
This analysis shows that there is no significant difference in 30-day mortality, neurological status, or rate of PCI among patients with OHCA without STE treated with early versus nonearly CAG. Thirty-day mortality is determined by presentation comorbidities rather than revascularization.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Oct 2020; 13:2193-2205
Verma BR, Sharma V, Shekhar S, Kaur M, ... Reed G, Kapadia S
JACC Cardiovasc Interv: 11 Oct 2020; 13:2193-2205 | PMID: 33032706
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Impact:
Abstract

Contemporary Transcatheter Mitral Valve Replacement for Mitral Annular Calcification or Ring.

Tiwana J, Aldea G, Levin DB, Johnson K, ... Reisman M, McCabe JM
Objectives
The aim of this study was to evaluate outcomes of commercial transcatheter mitral valve replacement (TMVR) for annular rings and calcification using contemporary techniques.
Background
TMVR is evolving in the absence of other viable treatment options for severe mitral annular calcification and failing ring repairs. The concomitant use of laceration of the anterior mitral valve leaflet to prevent left ventricular outflow tract obstruction and pre-emptive alcohol septal ablation is not well studied in clinical practice.
Methods
A single-center study was conducted of valve-in-mitral annular calcification (ViMAC) and valve-in-ring (ViRing) TMVR from September 2015 to April 2020. In-hospital and 30-day outcomes were assessed.
Results
Forty patients underwent TMVR (28 ViMAC and 12 ViRing). Sixteen ViMAC (57%) and 5 ViRing (42%) patients underwent attempted laceration of the anterior mitral valve leaflet to prevent left ventricular outflow tract obstruction. Three patients underwent pre-emptive alcohol septal ablation. The median index hospitalization was 7 days. Six patients died within 30 days of the procedure, 6 (21%) in the ViMAC group and none in the ViRing group. Five patients (13%) had left ventricular outflow tract obstruction: 4 (14%) in the ViMAC cohort and 1 (8%) in the ViRing cohort. Five patients (13%) had either intraprocedural valve embolization or late migration (4 ViMAC and 1 ViRing). Technical success defined according to Mitral Valve Academic Research Consortium criteria was present in 25 patients (63%): 9 (75%) in the ViRing cohort and 16 (57%) in the ViMAC cohort. At 30 days, the mitral valve gradient was significantly reduced (5.5 ± 2.1 vs. 10.6 ± 4.8; p < 0.01). Three patients (8%) had at least moderate residual mitral regurgitation.
Conclusions
Transcatheter ViMAC and ViRing can be successfully performed but frequently require the use of contemporary adjunctive techniques.

Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 26 Sep 2020; epub ahead of print
Tiwana J, Aldea G, Levin DB, Johnson K, ... Reisman M, McCabe JM
JACC Cardiovasc Interv: 26 Sep 2020; epub ahead of print | PMID: 33011142
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Impact:
Abstract

Long-Term Prognostic Impact of Restenosis of the Unprotected Left Main Coronary Artery Requiring Repeat Revascularization.

Wiebe J, Kuna C, Ibrahim T, Lösl M, ... Mehilli J, Kastrati A
Objectives
The aim of this study was to evaluate the prognostic impact of target lesion revascularization (TLR) of the unprotected left main coronary artery (ULMCA) after stent failure.
Background
Although drug-eluting stents are safe and effective for treatment of the ULMCA, increased rates of repeat revascularization have been observed.
Methods
This is a patient-level pooled analysis of the randomized ISAR-LEFT-MAIN (Drug-Eluting-Stents for Unprotected Left Main Stem Disease) and ISAR-LEFT-MAIN-2 (Drug-Eluting Stents to Treat Unprotected Coronary Left Main Disease) trials, in which patients underwent stenting of the ULMCA. The present analysis includes patients who underwent angiography during follow-up. Patients with TLR were compared with those without. Additional long-term clinical follow-up after TLR was conducted, and its influence on mortality was evaluated. Mortality was calculated using the Kaplan-Meier method. Predictors of mortality were assessed in a multivariate analysis.
Results
A total of 1,001 patients were eligible, of whom 166 experienced TLR. The 5-year mortality rate was 30.2% in patients with TLR compared with 17.3% in those without TLR (p < 0.001). In the multivariate analysis, glomerular filtration rate (-30 ml/min; hazard ratio [HR]: 2.25; 95% confidence interval [CI]: 1.54 to 3.27; p < 0.001), chronic obstructive pulmonary disease (HR: 4.95; 95% CI: 1.33 to 18.42; p = 0.02), and body mass index (+5 kg/m; HR: 1.61; 95% CI: 1.12 to 2.32; p = 0.01) were independent predictors of mortality after TLR due to left main stent failure. The type of repeat revascularization and the underlying stent did not influence the mortality after TLR of the ULMCA.
Conclusions
Mortality after TLR for left main stent failure is high. Patient-related factors seem to have a greater impact on mortality after TLR than other variables.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Oct 2020; 13:2266-2274
Wiebe J, Kuna C, Ibrahim T, Lösl M, ... Mehilli J, Kastrati A
JACC Cardiovasc Interv: 11 Oct 2020; 13:2266-2274 | PMID: 33032714
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Abstract

Evaluation of Mortality Following Paclitaxel Drug-Coated Balloon Angioplasty of Femoropopliteal Lesions in the Real World.

Böhme T, Noory E, Beschorner U, Jacques B, ... Nührenberg T, Zeller T
Objectives
This study sought to evaluate the long-term mortality after paclitaxel drug-coated balloon (DCB) angioplasty and plain old balloon angioplasty (POBA) of femoropopliteal lesions in real-world practice.
Background
A recent meta-analysis of randomized controlled trials suggested an increased long-term mortality risk following femoropopliteal angioplasty using paclitaxel-coated devices.
Methods
A retrospective mortality analysis of patients with at least 3-year follow-up who underwent balloon based endovascular therapy of femoropopliteal lesions was performed.
Results
Overall, 7,357 patients with femoropopliteal lesions were treated within the study period receiving either DCB angioplasty or POBA. Of those, 1,579 fulfilled the study criteria. A total of 514 patients were treated with POBA without crossover to a paclitaxel-coated device during follow-up and 1,065 patients were treated with DCB angioplasty. Mortality incidence at mean follow-up of 52.0 ± 20.5 months (median 51 months) was 27.8% after POBA and 16.9% after DCB angioplasty (p < 0.001). Equally, for a cohort excluding patients over 80 years of age, the mortality rate after POBA treatment was significantly higher (23.6% vs. 12.3%; p < 0.001). For the entire cohort, independent predictors for mortality were age (p < 0.001), type of treatment (p = 0.009), hyperlipidemia (p = 0.010), diabetes mellitus (p = 0.010), renal insufficiency (p = 0.007), stroke (p = 0.017), and Rutherford-Becker class 4 (p < 0.001). DCB length was not correlated to mortality rate. After propensity score matching, independent mortality predictors were POBA treatment (p = 0.035), age (p < 0.001), stroke (p = 0.025), and renal insufficiency (p = 0.007).
Conclusions
In this real-world retrospective analysis, the long-term mortality rate was lower after DCB angioplasty than after POBA of femoropopliteal lesions. Known comorbidities, risk factors, and disease severity were identified as mortality predictors but not paclitaxel.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Sep 2020; 13:2052-2061
Böhme T, Noory E, Beschorner U, Jacques B, ... Nührenberg T, Zeller T
JACC Cardiovasc Interv: 13 Sep 2020; 13:2052-2061 | PMID: 32593696
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Abstract

Electrosurgical Detachment of MitraClips From the Anterior Mitral Leaflet Prior to Transcatheter Mitral Valve Implantation.

Lisko JC, Greenbaum AB, Guyton RA, Kamioka N, ... Lederman RJ, Babaliaros VC
Objectives
The aim of this study was to test the hypothesis that transcatheter electrosurgery might allow intentional detachment of previously placed MitraClip(s) from the anterior leaflet to recreate a single mitral orifice for transcatheter mitral valve implantation (TMVI), leaving the retained MitraClip(s) securely fastened to the posterior leaflet and without interfering with the mitral bioprosthesis.
Background
Patients with severe mitral regurgitation or stenosis despite edge-to-edge mitral repair with the MitraClip typically have few therapeutic options because the resultant double orifice precludes TMVI. Transcatheter electrosurgery may allow detachment of failed MitraClip(s) from the anterior leaflet to recreate a single orifice for TMVI.
Methods
This was a single-center, 5-patient, consecutive, retrospective observational cohort. Patients underwent transcatheter electrosurgical laceration and stabilization of failed MitraClip(s) to recreate a single orifice, leaving the MitraClip(s) securely fastened to the posterior leaflet. Subsequently, patients underwent TMVI with an investigational device, the Tendyne mitral bioprosthesis, on a compassionate basis. Patients were followed up to 30 days.
Results
MitraClip detachment from the anterior leaflet and Tendyne implantation were successful in all patients. All patients survived to discharge. All patients were discharged with grade 0 central mitral regurgitation. Two patients had moderate perivalvular mitral regurgitation that did not require reintervention. During the follow-up period of 30 days, there were no deaths, cases of valve dysfunction, or reintervention. There was no evidence of erosion or bioprosthetic valve dysfunction attributable to the retained MitraClip(s) still attached to the posterior leaflet.
Conclusions
Transcatheter electrosurgical detachment of failed MitraClips from the anterior leaflet followed by TMVI is technically feasible and safe at 30 days. Longer term study is needed to determine the clinical benefit of this approach and new algorithms for TMVI sizing following electrosurgical laceration and stabilization of a failed MitraClip to avoid perivalvular leak.

Copyright © 2020. Published by Elsevier Inc.

JACC Cardiovasc Interv: 24 Sep 2020; epub ahead of print
Lisko JC, Greenbaum AB, Guyton RA, Kamioka N, ... Lederman RJ, Babaliaros VC
JACC Cardiovasc Interv: 24 Sep 2020; epub ahead of print | PMID: 33011144
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Abstract

Transcatheter Edge-to-Edge Mitral Valve Repair With the MitraClip G4 System.

Chakravarty T, Makar M, Patel D, Oakley L, ... Nakamura M, Makkar RR
Objectives
The primary objective of this study was to evaluate the effectiveness of the MitraClip G4 in the reduction of mitral regurgitation (MR).
Background
The next-generation MitraClip G4 system was recently introduced for the treatment of MR in the United States.
Methods
The study included consecutive patients undergoing transcatheter mitral edge-to-edge repair for MR with the MitraClip G4. The key outcome was the proportion of patients with MR reduction to ≤2+ at 30 days.
Results
Fifty-nine patients (median age 77 years, 62.7% men) were treated with the MitraClip G4. Reduction of MR to ≤2+ was achieved in 57 patients (96.6%) during the procedure, 58 patients (98.3%) at discharge, and 57 patients (96.6%) by 30 days. The median number of MitraClips used per patient was 2 (interquartile range: 1 to 3). Wide clips (NTW/XTW) were used in 82.7% of patients. The XTW clip was used most frequently as the first clip in patients with degenerative MR (65.4%) and the NTW clip in those with secondary MR (72.7%). The independent grasping mechanism was used in 49.2% of patients.
Conclusions
Use of the MitraClip G4 system was associated with excellent reduction in MR to ≤2+ in 96.6% of patients at 30 days. The availability of multiple MitraClip G4 sizes, especially the wide clips, and the ability to independently grasp leaflets are the likely contributors to MR reduction.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 24 Sep 2020; epub ahead of print
Chakravarty T, Makar M, Patel D, Oakley L, ... Nakamura M, Makkar RR
JACC Cardiovasc Interv: 24 Sep 2020; epub ahead of print | PMID: 33011141
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Abstract

Safety of Revascularization Deferral of Left Main Stenosis Based on Instantaneous Wave-Free Ratio Evaluation.

Warisawa T, Cook CM, Rajkumar C, Howard JP, ... Escaned J, Davies JE
Objectives
The aim of this study was to assess the long-term clinical outcomes of patients with left main coronary artery (LM) stenosis in whom treatment strategy was based on the instantaneous wave-free ratio (iFR).
Background
The overall safety of iFR to guide revascularization decision making in patients with stable coronary artery disease has been established. However, no study has examined the safety of deferral of revascularization of LM disease on the basis of iFR.
Methods
This multicenter observational study included 314 patients in whom LM stenosis was deferred (n = 163 [51.9%]) or revascularized (n = 151 [48.1%]) according to the iFR cutoff ≤0.89. The primary endpoint was a composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven target lesion revascularization. The secondary endpoints were each individual component of the primary endpoint and also cardiac death.
Results
At a median follow-up period of 30 months, the primary endpoint occurred in 15 patients (9.2%) in the deferred group and 22 patients (14.6%) in the revascularized group (hazard ratio: 1.45; 95% confidence interval: 0.75 to 2.81; p = 0.26), indicating no evidence of a significant difference between the 2 groups. For the secondary endpoints, findings in the iFR-based deferral and revascularization groups were as follows: all-cause death, 3.7% versus 4.6%; cardiac death, 1.2% versus 2.0%; nonfatal myocardial infarction, 2.5% versus 5.3%; and target lesion revascularization, 4.3% versus 5.3% (p > 0.05 for all).
Conclusions
Deferral of revascularization of LM stenosis on the basis of iFR appears to be safe, with similar long-term outcomes to those in patients in whom LM revascularization was performed according to iFR values.

Copyright © 2020. Published by Elsevier Inc.

JACC Cardiovasc Interv: 26 Jul 2020; 13:1655-1664
Warisawa T, Cook CM, Rajkumar C, Howard JP, ... Escaned J, Davies JE
JACC Cardiovasc Interv: 26 Jul 2020; 13:1655-1664 | PMID: 32417088
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Abstract

Transcatheter Aortic Valve Replacement in Bicuspid Versus Tricuspid Aortic Valves From the STS/ACC TVT Registry.

Forrest JK, Kaple RK, Ramlawi B, Gleason TG, ... Liu F, Reardon MJ
Objectives
This study sought to compare outcomes in patients with bicuspid versus tricuspid anatomy undergoing transcatheter aortic valve replacement (TAVR).
Background
TAVR has shown excellent safety and efficacy in patients with tricuspid aortic valve stenosis, but limited data are available on the use of self-expanding valves in patients with bicuspid valves.
Methods
The Society of Thoracic Surgeons/American College of Cardiology TVT Registry was used to analyze patients who underwent TAVR with the Evolut R or Evolut PRO valves. Clinical and echocardiographic outcomes were analyzed through 1-year follow-up.
Results
Between July 2015 and September 2018 a total of 932 patients with bicuspid aortic valve stenosis underwent elective TAVR with the self-expanding Evolut R or Evolut PRO valve. These patients were compared with a group of 26,154 patients with tricuspid aortic stenosis who underwent TAVR during that same time period. At baseline, patients with bicuspid valves were younger, had fewer cardiac comorbidities, and had lower Society of Thoracic Surgeons Predicted Risk of Mortality scores (5.3 ± 4.2% vs. 6.9 ± 4.8%; p < 0.001). To account for these differences, propensity matching was performed, which resulted in 929 matched pairs. Within these match groups, the rates of all-cause mortality at 30 days (2.6% vs. 1.7%; p = 0.18) and 1 year (10.4% vs. 12.1%; p = 0.63), as well the rate of stroke at 30 days (3.4% vs. 2.7%; p = 0.41) and 1 year (3.9% vs. 4.4%; p = 0.93), were comparable.
Conclusions
All-cause mortality, stroke, and valve hemodynamics did not differ at 30 days or 1 year between patient groups. In patients at increased surgical risk, TAVR for bicuspid aortic valve stenosis indicates acceptable safety outcomes with low complications rates.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 09 Aug 2020; 13:1749-1759
Forrest JK, Kaple RK, Ramlawi B, Gleason TG, ... Liu F, Reardon MJ
JACC Cardiovasc Interv: 09 Aug 2020; 13:1749-1759 | PMID: 32473890
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Abstract

Effect of Sex Difference of Coronary Microvascular Dysfunction on Long-Term Outcomes in Deferred Lesions.

Chung JH, Lee KE, Lee JM, Her AY, ... Koo BK, Shin ES
Objectives
This study investigated the sex difference of long-term cardiovascular outcomes on coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) in patients with deferred coronary artery lesions.
Background
Coronary microvascular dysfunction is associated with poorer long-term outcomes. It can be assessed by CFR and the IMR.
Methods
The study prospectively enrolled 434 patients (133 women and 301 men) and analyzed CFR, IMR, fractional flow reserve, and quantitative coronary angiography. Clinical outcomes were assessed by major adverse cardiovascular event(s) (MACE) of cardiac death, myocardial infarction, and revascularization during 5 years of follow-up. The study protocol was approved by the Institutional Review Board or Ethics Committee at each participating center, and all patients provided written informed consent. The study protocol was in accordance with the Declaration of Helsinki.
Results
Women had milder epicardial disease compared with men (fractional flow reserve: 0.91 [interquartile range (IQR): 0.87 to 0.96] vs. 0.90 [IQR: 0.86 to 0.95]; p = 0.037). IMR was similar between the sexes, but CFR was lower in women (2.69 [IQR: 2.08 to 3.90] vs. 3.20 [IQR: 2.20 to 4.31]; p = 0.006) due to a shorter resting mean transit time, whereas hyperemic mean transit times were similar. At 5-year follow-up, MACE was significantly lower in women compared with men (1.1% vs. 5.5%; p = 0.017). Sex, diabetes mellitus, and CFR were independent predictors for MACE for all patients. The risk of MACE was significantly higher in men with low versus high CFR (hazard ratio: 4.58; 95% confidence interval: 1.85 to 11.30; p = 0.011) which was not seen in women.
Conclusions
There was no sex difference in microvascular function by IMR. CFR was lower in women due to a higher resting coronary flow; however, long-term clinical outcomes in deferred lesions were better in women compared with men. (Clinical, Physiological and Prognostic Implication of Microvascular Status; NCT02186093).

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 26 Jul 2020; 13:1669-1679
Chung JH, Lee KE, Lee JM, Her AY, ... Koo BK, Shin ES
JACC Cardiovasc Interv: 26 Jul 2020; 13:1669-1679 | PMID: 32593698
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Abstract

Arterial Lactate in Cardiogenic Shock: Prognostic Value of Clearance Versus Single Values.

Fuernau G, Desch S, de Waha-Thiele S, Eitel I, ... Zeymer U, Thiele H
Objectives
This study sought to compare single lactate values at admission (L1) and after 8 h (L2) with lactate clearance (LC) for mortality prediction in cardiogenic shock (CS).
Background
Early estimation of prognosis in CS complicating acute myocardial infarction is crucial for tailored treatment selection. Arterial lactate is the most widely used point-of-care parameter in CS. In septic shock, lactate reduction over time-LC-has been extensively investigated. However, in CS, only limited data exist, and the prognostic value of LC is unknown.
Methods
This study is a subanalysis of the IABP-SHOCK II (Intraaortic Balloon Pump in Cardiogenic Shock II) trial and the corresponding registry. Lactate levels were prospectively collected. All-cause mortality at 30 days was assessed as primary endpoint.
Results
For 671 of 783 (85.7%) patients, L1 and L2 values were available. The area under the receiver-operating characteristic curve (L1: 0.69; L2: 0.76; LC: 0.59) showed no difference between L1 and LC (p = 0.20). In contrast, L2 was a significantly better predictive parameter than L1 or LC (p < 0.001 for both). In multivariable stepwise Cox regression analysis, L2 ≥3.1 mmol/l (best cutoff value by Youden index) and LC <-3.45%/h remained independently predictive for time to death (p < 0.001 for both), with L2 showing the highest chi-square test score (42.1) and hazard ratio (2.89; 95% confidence interval: 2.10 to 3.97).
Conclusions
Arterial lactate after 8 h is superior in mortality prediction in comparison with baseline lactate and LC. A cutoff value of 3.1 mmol/l for lactate after 8 h showed the best discrimination for assessing early prognosis in CS and may serve as new treatment goal. (Intraaortic Balloon Pump in Cardiogenic Shock II [IABP-SHOCK II]; NCT00491036).

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 11 Oct 2020; 13:2208-2216
Fuernau G, Desch S, de Waha-Thiele S, Eitel I, ... Zeymer U, Thiele H
JACC Cardiovasc Interv: 11 Oct 2020; 13:2208-2216 | PMID: 33032708
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Abstract

Patient-Specific Computer Simulation in TAVR With the Self-Expanding Evolut R Valve.

El Faquir N, De Backer O, Bosmans J, Rudolph T, ... Van Mieghem N, de Jaegere P
Objectives
The aim of this study was to assess the added value and predictive power of the TAVIguide (Added Value of Patient-Specific Computer Simulation in Transcatheter Aortic Valve Implantation) software in clinical practice.
Background
Optimal outcome after transcatheter aortic valve replacement (TAVR) may become more important as TAVR shifts toward low-risk patients. Patient-specific computer simulation is able to provide prediction of outcome after TAVR. Its clinical role and validation of accuracy, however, have not yet been studied prospectively.
Methods
A prospective, observational, multicenter study was conducted among 80 patients with severe aortic stenosis treated with the Evolut R valve. Simulation was performed in 42 patients and no simulation in 38. A comparison between the valve size (decision 1) and target depth of implantation selected by the operator on the basis of multislice computed tomography and the valve size (decision 2) and target depth of implantation selected after simulation were the primary endpoints. Predictive power was examined by comparing the simulated and observed degree of aortic regurgitation.
Results
Decision 2 differed from decision 1 in 1 of 42 patients because of predicted paravalvular leakage, and changes in valve type occurred in 2 of 42. In 39 of 42 patients, decisions 1 and 2 were similar. Target depth of implantation differed in 7 of 42 patients after simulation (lower in 4 and higher in 3). In 16 of 42 patients, simulation affected the TAVR procedure; in 9, the operator avoided additional measures to achieve the target depth of implantation, and in 7 patients, additional measures were performed. There was a trend toward a higher degree of predicted than observed aortic regurgitation (17.5 vs. 12 ml/s; p = 0.13).
Conclusions
Patient-specific computer simulation did not affect valve size selection but did affect the selection of the target depth of implantation and the execution of TAVR to achieve the desired target depth of implantation.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 09 Aug 2020; 13:1803-1812
El Faquir N, De Backer O, Bosmans J, Rudolph T, ... Van Mieghem N, de Jaegere P
JACC Cardiovasc Interv: 09 Aug 2020; 13:1803-1812 | PMID: 32682679
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Impact:
Abstract

Validation of Administrative Claims to Ascertain Outcomes in Pivotal Trials of Transcatheter Aortic Valve Replacement.

Butala NM, Strom JB, Faridi KF, Kazi DS, ... Shen C, Yeh RW
Objectives
The aim of this study was to evaluate the performance of administrative claims in ascertaining trial clinical events committee-adjudicated outcomes in the U.S. CoreValve studies.
Background
Real-world data offer tremendous opportunity to improve outcome ascertainment in clinical trials. However, little is known about the validity of outcomes ascertained using real-world data to capture trial endpoints.
Methods
Patients enrolled in 3 pivotal trials and 2 pre-market continued-access studies evaluating transcatheter aortic valve replacement were linked to Medicare fee-for-service inpatient claims. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and kappa agreement statistic of claims to detect clinical endpoints and procedural complications in trial patients were calculated.
Results
Claims accurately identified trial-adjudicated deaths (sensitivity, specificity, PPV, and NPV all >99.6%; kappa 1.00). Claims had good performance in identifying trial-adjudicated permanent pacemaker implantation (sensitivity 92.2%, specificity 99.1%, PPV 96.1%, NPV 98.2%, kappa 0.93) and aortic valve reintervention (sensitivity 84.4%, specificity 99.6%, PPV 69.1%, NPV 99.8%, kappa 0.76). Claims had more modest performance in ascertaining trial-adjudicated myocardial infarction (sensitivity 63.6%, specificity 97.2%, PPV 29.9%, NPV 99.3%, kappa 0.39) and acute kidney injury (sensitivity 70.2%, specificity 85.4%, PPV 38.2%, NPV 95.7%, kappa 0.41) and the poorest performance for identifying trial-adjudicated bleeding events (sensitivity 86.4%, specificity 36.8%, PPV 35.0%, NPV 86.3%, kappa 0.16).
Conclusions
Compared with trial-adjudicated outcomes, claims data performed well in ascertaining death and outcomes with procedural billing codes and more modestly in identifying other outcomes. Claims may be cautiously and selectively used to augment data collection in future cardiovascular device trials.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 09 Aug 2020; 13:1777-1785
Butala NM, Strom JB, Faridi KF, Kazi DS, ... Shen C, Yeh RW
JACC Cardiovasc Interv: 09 Aug 2020; 13:1777-1785 | PMID: 32682677
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Impact:
Abstract

Prolonged Continuous Electrocardiographic Monitoring Prior to Transcatheter Aortic Valve Replacement: The PARE Study.

Asmarats L, Nault I, Ferreira-Neto AN, Muntané-Carol G, ... Philippon F, Rodés-Cabau J
Objectives
This study sought to determine, using continuous electrocardiographic monitoring (CEM) pre-transcatheter aortic valve replacement (TAVR), the incidence and type of unknown pre-existing arrhythmic events (AEs) in TAVR candidates, and to evaluate the occurrence and impact of therapeutic changes secondary to the detection of AEs pre-TAVR.
Background
Scarce data exist on the arrhythmic burden of TAVR candidates (pre-procedure).
Methods
This was a prospective study including 106 patients with severe aortic stenosis and no prior permanent pacemaker screened for TAVR. A prolonged (1 week) CEM was implanted within the 3 months pre-TAVR. Following heart team evaluation, 90 patients underwent elective TAVR.
Results
New AEs were detected by CEM in 51 (48.1%) patients, leading to a treatment change in 14 of 51 (27.5%) patients. Atrial fibrillation or tachycardia was detected in 8 of 79 (10.1%) patients without known atrial fibrillation or tachycardia, and nonsustained ventricular arrhythmias were detected in 31 (29.2%) patients. Significant bradyarrhythmias were observed in 22 (20.8%) patients, leading to treatment change and permanent pacemaker in 8 of 22 (36.4%) and 4 of 22 (18.2%) patients, respectively. The detection of bradyarrhythmias increased up to 30% and 47% among those patients with pre-existing first-degree atrioventricular block and right bundle branch block, respectively. Chronic renal failure, higher valve calcification, and left ventricular dysfunction determined (or tended to determine) an increased risk of AEs pre-TAVR (p = 0.028, 0.052, and 0.069, respectively). New onset AEs post-TAVR occurred in 22.1% of patients, and CEM pre-TAVR allowed early arrhythmia diagnosis in one-third of them.
Conclusions
Prolonged CEM in TAVR candidates allowed identification of previously unknown AEs in nearly one-half of the patients, leading to prompt therapeutic measures (pre-TAVR) in about one-fourth of them. Pre-existing conduction disturbances (particularly right bundle branch block) and chronic renal failure were associated with a higher burden of AEs.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 09 Aug 2020; 13:1763-1773
Asmarats L, Nault I, Ferreira-Neto AN, Muntané-Carol G, ... Philippon F, Rodés-Cabau J
JACC Cardiovasc Interv: 09 Aug 2020; 13:1763-1773 | PMID: 32682674
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Impact:
Abstract

CT-Determined Tricuspid Annular Dilatation Is Associated With Increased 2-Year Mortality in TAVR Patients.

Deseive S, Steffen J, Beckmann M, Jochheim D, ... Massberg S, Hausleiter J
Objectives
The aim of this study was to investigate the prevalence and prognostic impact of tricuspid annular dilatation (TAD) measured in multislice computed tomography datasets in patients undergoing transfemoral transcatheter aortic valve replacement for severe aortic stenosis.
Background
TAD is an increasingly recognized entity associated with poor outcomes in patients with valvular heart disease.
Methods
The maximal septolateral diameter of the tricuspid annulus was measured in consecutive patients with 3-dimensional multidetector row computed tomographic datasets undergoing transfemoral transcatheter aortic valve replacement. Receiver-operating curve characteristic analysis was performed to obtain an ideal, body surface area-normalized cutoff for TAD. Ethical approval was obtained from the institutional ethics board.
Results
The study included 1,137 patients, of whom 299 died within a mean follow-up period of 1.8 ± 1.0 years. TAD was identified in 446 patients (39.2%) on the basis of a receiver-operating characteristic cutoff of 23 mm/m. TAD had no impact on procedural outcomes, including device failure defined according to Valve Academic Research Consortium-2 criteria. Patients with TAD experienced significantly greater mortality (hazard ratio: 1.99; 95% confidence interval: 1.59 to 2.51; p < 0.001). Multivariate analysis including clinical and echocardiographic parameters confirmed the predictive value of TAD (hazard ratio: 1.78; 95% confidence interval: 1.33 to 2.38; p < 0.001), while echocardiographic variables, including estimated pulmonary artery pressure and the severity of tricuspid regurgitation, did not reach statistical significance. The predictive value of TAD was incremental to a baseline model of clinical and echocardiographic parameters (continuous net reclassification improvement 0.204; p < 0.01) and incremental to the Society of Thoracic Surgeons score (continuous net reclassification improvement 0.209; p < 0.001).
Conclusions
TAD is an independent predictor of all-cause mortality in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Oct 2020; epub ahead of print
Deseive S, Steffen J, Beckmann M, Jochheim D, ... Massberg S, Hausleiter J
JACC Cardiovasc Interv: 10 Oct 2020; epub ahead of print | PMID: 33069658
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Impact:
Abstract

Alterra Adaptive Prestent and SAPIEN 3 THV for Congenital Pulmonic Valve Dysfunction: An Early Feasibility Study.

Shahanavaz S, Balzer D, Babaliaros V, Kim D, ... Gorelick J, Zahn EM
Objectives
The aim of this study was to demonstrate the safety and functionality of the Alterra Adaptive Prestent and SAPIEN 3 transcatheter heart valve (THV) in patients with dysfunctional, dilated right ventricular outflow tract (RVOT) greater or equal to moderate pulmonary regurgitation (PR).
Background
Significant variations in the size and morphology of the RVOT affect the placement of transcatheter pulmonary valves. The Alterra Prestent internally reduces and reconfigures the RVOT, providing a stable landing zone for the 29-mm SAPIEN 3 THV.
Methods
Eligible patients had moderate or greater PR, weighed >20 kg, and had RVOT diameter 27 to 38 mm and length >35 mm. The primary endpoint was device success, a 5-item composite: 1 Alterra Prestent deployed in the desired location, 1 SAPIEN 3 THV implanted in the desired location within the Prestent, right ventricular-to-pulmonary artery peak-to-peak gradient <35 mm Hg after THV implantation, less than moderate PR at discharge, and no explantation 24 h post-implantation. The secondary composite endpoint was freedom from THV dysfunction (RVOT/pulmonary valve (PV) reintervention, greater or equal to moderate total PR, mean RVOT/PV gradient ≥ 35 mm Hg at 30 days and 6 months. Descriptive statistics are reported.
Results
Enrolled patients (N = 15) had a median age and weight of 20 years and 61.7 kg, respectively; 93.3% were in New York Heart Association functional class I or II. Device success was 100%. No staged procedures were necessary. No THV dysfunction was reported to 6 months. No serious safety signals were reported.
Conclusions
This early feasibility study demonstrated the safety and functionality of the Alterra Adaptive Prestent in patients with congenital RVOT dysfunction and moderate or greater PR. Durability and long-term outcome data are needed.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Oct 2020; epub ahead of print
Shahanavaz S, Balzer D, Babaliaros V, Kim D, ... Gorelick J, Zahn EM
JACC Cardiovasc Interv: 10 Oct 2020; epub ahead of print | PMID: 33069657
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Abstract

Transcatheter Mitral Valve Repair in Cardiogenic Shock and Mitral Regurgitation: A Patient-Level, Multicenter Analysis.

Jung RG, Simard T, Kovach C, Flint K, ... Taramasso M, Hibbert B
Objectives
The aim of this study was to evaluate the outcome of transcatheter mitral valve repair (TMVr) in patients with cardiogenic shock and significant mitral regurgitation (MR).
Background
Patients in cardiogenic shock with severe MR have a poor prognosis in the setting of conventional medical therapy. Because of its favorable safety profile, TMVr is being increasingly used as an acute therapy in this population, though its efficacy remains unknown.
Methods
A multicenter, collaborative, patient-level analysis was conducted. Patients with cardiogenic shock and moderate to severe (3+) or severe (4+) MR who were not surgical candidates were treated with TMVr. The primary outcome was in-hospital mortality Secondary outcomes included 90-day mortality, heart failure (HF) hospitalization, and the combined event rate of 90-day mortality and HF hospitalization following dichotomization by TMVr device success.
Results
Between January 2011 and February 2019, 141 patients across 14 institutions met the inclusion criteria. In-hospital mortality occurred in 22 patients (15.6%), at 90 days in 38 patients (29.5%), and at one year in 55 patients (42.6%). Median length of hospital stay following TMVr was 10 days (interquartile range: 6 to 20 days). HF hospitalization occurred in 26 patients (18.4%) at a median of 73 days (interquartile range: 26 to 546 days). When stratified by TMVr procedural results, successful TMVr reduced rates of in-hospital mortality (hazard ratio [HR]: 0.36; 95% confidence interval [CI]: 0.13 to 0.98; p = 0.04), 90-day mortality (HR: 0.36; 95% CI: 0.16 to 0.78; p = 0.01), and the composite of 90-day mortality and HF hospitalization (HR: 0.41; 95% CI: 0.19 to 0.90; p = 0.03).
Conclusions
TMVr may improve short- and intermediate-term mortality in high-risk patients with cardiogenic shock and moderate to severe MR. Randomized studies are needed to definitively establish MR as a therapeutic target in patients with cardiogenic shock.

Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Oct 2020; epub ahead of print
Jung RG, Simard T, Kovach C, Flint K, ... Taramasso M, Hibbert B
JACC Cardiovasc Interv: 10 Oct 2020; epub ahead of print | PMID: 33069653
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Abstract

Automated Algorithm Using Pre-Intervention Fractional Flow Reserve Pullback Curve to Predict Post-Intervention Physiological Results.

Lee SH, Shin D, Lee JM, Lefieux A, ... Choi SH, Gwon HC
Objectives
The authors sought to develop an automated algorithm using pre-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) pullback recordings to predict post-PCI physiological results in the pre-PCI phase.
Background
Both FFR and percent FFR increase measured after PCI showed incremental prognostic implications. However, there is no current method to predict post-PCI physiological results using physiological assessment in the pre-PCI phase.
Methods
An automated algorithm that analyzes instantaneous FFR gradient per unit time (dFFR(t)/dt) was developed from the derivation cohort (n = 30). Using dFFR(t)/dt, the pattern of atherosclerotic disease in each patient was classified into 3 groups (major, mixed, and minor FFR gradient groups) in both the internal validation cohort with constant pullback method (n = 234) and the external validation cohort with nonstandardized pullback methods (n = 252). All patients in the validation cohorts underwent PCI on the basis of pre-PCI FFR ≤0.80. Suboptimal post-PCI physiological results were defined as both post-PCI FFR <0.84 and percent FFR increase ≤15%. From the derivation cohort, cutoffs of dFFR(t)/dt for major and minor FFR gradient were 0.035/s and 0.015/s, respectively.
Results
In validation cohorts, dFFR(t)/dt showed significant correlations with percent FFR increase (R = 0.801; p < 0.001) and post-PCI FFR (R = 0.099; p = 0.029). In both the internal and external validation cohorts, the major FFR gradient group showed significantly higher post-PCI FFR and percent FFR increase compared with those in the mixed or minor FFR gradient groups (all p values <0.001). The proportions of suboptimal post-PCI physiological results were significantly different among 3 groups (10.4% vs. 25.8% vs. 45.7% for the major, mixed, and minor FFR gradient groups, respectively; p < 0.001) in validation cohorts. Absence of major FFR gradient lesion (odds ratio: 2.435, 95% [CI]: 1.252 to 4.734; p = 0.009) and presence of minor FFR gradient lesion (odds ratio: 2.756, 95% confidence interval: 1.629 to 4.664; p < 0.001) were independent predictors for suboptimal post-PCI physiological results.
Conclusions
The automated algorithm analyzing pre-PCI pullback curve was able to predict post-PCI physiological results. The incidence of suboptimal post-PCI physiological results was significantly different according to algorithm-based classifications in the pre-PCI physiological assessment. (Automated Algorithm Detecting Physiologic Major Stenosis and Its Relationship with Post-PCI Clinical Outcomes [Algorithm-PCI]; NCT04304677).

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Oct 2020; epub ahead of print
Lee SH, Shin D, Lee JM, Lefieux A, ... Choi SH, Gwon HC
JACC Cardiovasc Interv: 10 Oct 2020; epub ahead of print | PMID: 33069650
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Abstract

Coronary Cannulation After Transcatheter Aortic Valve Replacement: The RE-ACCESS Study.

Barbanti M, Costa G, Picci A, Criscione E, ... Webb JG, Tamburino C
Objectives
The aims of this study were to investigate the feasibility of coronary ostia cannulation after transcatheter aortic valve replacement (TAVR) and to assess potential predictors of coronary access impairment.
Background
Certain data concerning the feasibility and reproducibility of coronary cannulation after TAVR are lacking.
Methods
RE-ACCESS (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent) was an investigator-driven, single-center, prospective, registry-based study that enrolled consecutive patients undergoing TAVR using all commercially available devices. All patients underwent coronary angiography before and after TAVR. The primary endpoint was the rate of unsuccessful coronary ostia cannulation after TAVR. Secondary endpoints were the identification of factors associated with the inability to selectively cannulate coronary ostia after TAVR.
Results
Among 300 patients enrolled in the RE-ACCESS study from December 2018 to January 2020, a total of 23 cases (7.7%) of unsuccessful coronary cannulation after TAVR were documented. This issue occurred in 22 of 23 cases with the use of Evolut R/PRO transcatheter aortic valves (TAVs) (17.9% vs. 0.4%; p < 0.01). In multivariate analysis, the use of Evolut R/PRO TAVs (odds ratio [OR]: 29.6; 95% confidence interval [CI]: 2.6 to 335.0; p < 0.01), the TAV-sinus of Valsalva relation (OR: 1.1 per 1-mm increase; 95% CI: 1.0 to 1.2; p < 0.01), and the mean TAV implantation depth (OR: 1.7 per 1-mm decrease; 95% CI: 1.3 to 2.3; p < 0.01) were found to be independent predictors of unsuccessful coronary cannulation after TAVR. A model combining these factors was demonstrated to predict with very high accuracy the risk for unsuccessful coronary cannulation after TAVR (area under the curve: 0.94; p < 0.01).
Conclusions
Unsuccessful coronary cannulation following TAVR was observed in 7.7% of patients and occurred almost exclusively in those receiving Evolut TAVs. The combination of Evolut TAV, a higher TAV-sinus of Valsalva relation, and implantation depth predicts with high accuracy the risk for unsuccessful coronary cannulation after TAVR. (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS); NCT04026204).

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Oct 2020; epub ahead of print
Barbanti M, Costa G, Picci A, Criscione E, ... Webb JG, Tamburino C
JACC Cardiovasc Interv: 10 Oct 2020; epub ahead of print | PMID: 33069648
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Abstract

Procedural Characteristics and Late Outcomes of Percutaneous Coronary Intervention in the Workup Pre-TAVR.

Faroux L, Campelo-Parada F, Munoz-Garcia E, Nombela-Franco L, ... Couture T, Rodés-Cabau J
Objectives
This study sought to determine, in patients undergoing percutaneous coronary intervention (PCI) during the work-up pre-transcatheter aortic valve replacement (TAVR): 1) the clinical and periprocedural PCI characteristics; 2) the long-term outcomes; and 3) the clinical events in those patients with complex coronary features.
Background
A PCI is performed in about 25% of TAVR candidates, but procedural features and late outcomes of pre-TAVR PCI remain largely unknown.
Methods
Multicenter study including 1197 consecutive patients who had PCI in the work-up pre-TAVR. A total of 1,705 lesions (1.5 ± 0.7 lesions per patient) were included. Death, stroke, myocardial infarction, and major adverse cardiovascular and cerebrovascular events (MACCE) were recorded, as well as target lesion failure (TLF) and target vessel failure (TVF).
Results
Half of patients exhibited a multivessel disease and the mean SYNTAX (SYNergy between PCI with TAXUS and Cardiac Surgery) score was 12.1 ± 9.1. The lesions were of B2/C type, calcified, bifurcation, and ostial in 49.9%, 45.8%, 21.4%, and 19.3% of cases, respectively. After a median follow-up of 2 (interquartile range: 1 to 3) years, a total of 444 (37.1%) patients presented an MACCE. Forty patients exhibited TVF (3.3%), with TLF identified in 32 (2.7%) patients. By multivariable analysis, previous peripheral artery disease (p < 0.001), chronic obstructive pulmonary disease (p = 0.002), atrial fibrillation (p = 0.003), diabetes mellitus (p = 0.012), and incomplete revascularization (p = 0.014) determined an increased risk of MACCE. In patients with unprotected left main or SYNTAX score >32 (n = 128), TLF, TVF, and MACCE rates were 3.9%, 6.3%, and 35.9%, respectively (p = 0.378; p = 0.065, and p = 0.847, respectively, vs. the rest of the population).
Conclusions
Patients undergoing PCI in the work-up pre-TAVR frequently exhibited complex coronary lesions and multivessel disease. PCI was successful in most cases, and TLF and TVF rates at 2-year follow-up were low, also among patients with high-risk coronary features. However, overall MACCE occurred in about one-third of patients, with incomplete revascularization determining an increased risk. These results should inform future studies to better determine the optimal revascularization strategy pre-TAVR.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Oct 2020; epub ahead of print
Faroux L, Campelo-Parada F, Munoz-Garcia E, Nombela-Franco L, ... Couture T, Rodés-Cabau J
JACC Cardiovasc Interv: 10 Oct 2020; epub ahead of print | PMID: 33069647
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Abstract

Overcoming Obstacles in Designing and Sustaining a High-Quality Cardiovascular Procedure Environment.

Klein LW, Dehmer GJ, Anderson HV, Rao SV

Accurate evaluation of the quality of invasive cardiology procedures requires appraisal of case selection, technical performance, and procedural and clinical outcomes. Regrettably, the medical care delivery system poses a number of obstacles to developing and sustaining a high-quality environment. The purposes of this viewpoint are to summarize the most common impediments, followed to summarize the most common impediments, followed by the optimal ways to design and sustain a quality assurance program to overcome these barriers. A 7-step program to create and implement an effective quality assurance program is outlined.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Oct 2020; epub ahead of print
Klein LW, Dehmer GJ, Anderson HV, Rao SV
JACC Cardiovasc Interv: 10 Oct 2020; epub ahead of print | PMID: 33069644
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Abstract

Early Experience With a Novel Transfemoral Mitral Valve Implantation System in Complex Degenerative Mitral Regurgitation.

Alperi A, Dagenais F, Del Val D, Bernier M, ... Granada JF, Rodés-Cabau J
Objectives
The aim of this study was to evaluate the feasibility, procedural results, and 6-month outcomes of a novel transfemoral transcatheter mitral valve implantation (TMVI) system (Cephea) in patients with complex primary mitral regurgitation (MR).
Background
TMVI is emerging as an alternative to surgery in patients with severe MR. To date, the great majority of TMVI systems use the transapical surgical approach.
Methods
This study included consecutive patients undergoing transfemoral TMVI with the Cephea valve system. All patients were suboptimal candidates for catheter-based repair for anatomic reasons. Patients underwent clinical, echocardiographic, and computed tomographic angiographic follow-up at 6 months. Main outcomes were procedural success, peri-procedural complications, and valve hemodynamic status early and at 6-month follow-up.
Results
Three patients with severe primary MR (2 women, mean age 79 ± 3 years) at prohibitive surgical risk (mean European System for Cardiac Operative Risk Evaluation II score 13.8 ± 2.4%) were included. The valves were successfully implanted in all patients, with no procedural complications. Post-procedural echocardiography showed normal valve function in all patients (mean transvalvular gradient 3 mm Hg; range: 2 to 4 mm Hg), no moderate to severe valvular or paravalvular leak, and no clinically significant left ventricular outflow tract obstruction. At 6 months, all patients had improved quality of life (mean improvement vs. baseline 16.4 ± 12 points). All valve hemodynamic parameters were maintained. Computed tomographic angiography confirmed annular stability, proper valve geometry and no structural failure.
Conclusions
The transfemoral delivery of a purposely designed mitral prosthesis (Cephea valve) was safe and feasible in prohibitive risk patients. Valve performance was sustained, and clinical outcomes improved at 6 months. Larger clinical studies are required.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Oct 2020; epub ahead of print
Alperi A, Dagenais F, Del Val D, Bernier M, ... Granada JF, Rodés-Cabau J
JACC Cardiovasc Interv: 10 Oct 2020; epub ahead of print | PMID: 33069643
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This program is still in alpha version.