Journal: JACC Cardiovasc Interv

Sorted by: date / impact
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 © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 10 Jan 2021; 14:1-11
Jung RG, Simard T, Kovach C, Flint K, ... Taramasso M, Hibbert B
JACC Cardiovasc Interv: 10 Jan 2021; 14:1-11 | PMID: 33069653
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Abstract

Should Interventional Cardiologists Super-Subspecialize?: Moving From Patient Selection to Operator Selection.

Kleiman NS, Welt FGP, Truesdell AG, Sherwood M, ... Rab T,

The field of interventional cardiology has expanded rapidly. As a result, four evolving areas have evolved - peripheral vascular interventions, structural heart interventions, adult congenital heart intervention, and chronic total occlusion. The complexity of these procedures and the number of devices available has grown rapidly. In addition, the professional and public expectations of procedural success and of minimizing case-avoidance have also grown. Specific issues include volume-outcome relationships, maintaining currency and proficiency, accessibility to specialized procedures, and the need to maintain a fundamental level of expertise in acute coronary interventions.

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

JACC Cardiovasc Interv: 10 Jan 2021; 14:97-100
Kleiman NS, Welt FGP, Truesdell AG, Sherwood M, ... Rab T,
JACC Cardiovasc Interv: 10 Jan 2021; 14:97-100 | PMID: 33413871
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Abstract

Peridevice Leak Following Amplatzer Left Atrial Appendage Occlusion: Cardiac Computed Tomography Classification and Clinical Outcomes.

Korsholm K, Jensen JM, Nørgaard BL, Samaras A, ... Tzikas A, Nielsen-Kudsk JE
Objectives
This study aimed to investigate cardiac computed tomography (CT) and transesophageal echocardiography (TEE) peridevice leak (PDL) assessments, and the clinical relevance of PDL.
Background
PDL assessment is integral during follow-up after left atrial appendage (LAA) occlusion. Comparative studies of TEE and cardiac CT are sparse, and the clinical relevance of PDL is uncertain.
Methods
This was a single-center observational study of consecutive patients undergoing LAA occlusion with Amplatzer devices (Amplatzer Cardiac Plug/Amulet) between 2010 and 2018 (N = 415). Patients with both 8-week CT and TEE were included for analysis (n = 346). Images were analyzed by blinded investigators (K.K. and A.S.). PDL on cardiac CT was classified from grade 1 to 3, based on PDL at the device disc, device lobe, and LAA contrast patency. Primary clinical outcome was a composite of ischemic stroke, transient ischemic attack, systemic embolism, or all-cause death.
Results
PDL was present in 110 patients (32%) by TEE, with 29 (8%) >3 mm. By cardiac CT, 210 patients (61%) had PDL at the disc, with contrast patency in 204 patients (59%). A grade 3 PDL (gap at disc, lobe, and LAA contrast patency) was present in 63 patients (18%). Bland-Altman analysis showed poor agreement between CT and TEE for leak sizing. CT and TEE detected PDL was not significantly associated with worse outcome, hazard ratio: 1.82 (95 % confidence interval: 0.95 to 3.50); p = 0.07 and hazard ratio: 1.43 (95% confidence interval: 0.74 to 2.76); p = 0.28, respectively.
Conclusions
PDL occurrence is substantially higher with CT compared with TEE, with a large discrepancy between modalities in leak quantification. A novel CT-based classification is proposed, yet PDL was not associated with worse clinical outcome.

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

JACC Cardiovasc Interv: 10 Jan 2021; 14:83-93
Korsholm K, Jensen JM, Nørgaard BL, Samaras A, ... Tzikas A, Nielsen-Kudsk JE
JACC Cardiovasc Interv: 10 Jan 2021; 14:83-93 | PMID: 33413869
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Abstract

Clinical Outcomes Associated With Left Atrial Appendage Occlusion Versus Direct Oral Anticoagulation in Atrial Fibrillation.

Nielsen-Kudsk JE, Korsholm K, Damgaard D, Valentin JB, ... Camm AJ, Johnsen SP
Objectives
This study sought to investigate clinical outcomes associated with left atrial appendage occlusion (LAAO) versus direct oral anticoagulants (DOACs) in patients with high-risk atrial fibrillation (AF).
Background
LAAO has been shown to be noninferior to warfarin for stroke prevention in AF. However, anticoagulation with DOACs is now preferred over warfarin as thromboprophylaxis in AF.
Methods
Patients with AF enrolled in the Amulet Observational Registry (n = 1,088) who had successful LAAO with the Amplatzer Amulet device (n = 1,078) were compared with a propensity score-matched control cohort of incident AF patients (n = 1,184) treated by DOACs identified from Danish national patient registries. Propensity score matching was based on the covariates of the CHADS-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category) and HAS-BLED (hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol) scores for predicting stroke and bleeding. The primary outcome was a composite of ischemic stroke, major bleeding (Bleeding Academic Research Consortium ≥3), or all-cause mortality, and follow-up was 2 years.
Results
AF patients treated with LAAO had a significantly lower risk of the primary composite outcome as compared with patients treated with DOACs (hazard ratio [HR]: 0.57; 95% confidence interval [CI]: 0.49 to 0.67). Total events and event rates per 100 patient-years were (LAAO vs. DOACs) 256 vs. 461 and 14.5 vs. 25.7, respectively. The risk of ischemic stroke was comparable between groups (HR: 1.11; 95% CI: 0.71 to 1.75), while risk of major bleeding (HR: 0.62; 95% CI: 0.49 to 0.79) and all-cause mortality (HR: 0.53; 95% CI: 0.43 to 0.64) were significantly lower in patients treated with LAAO.
Conclusions
Among high-risk AF patients, LAAO in comparison with DOACs may have similar stroke prevention efficacy but lower risk of major bleeding and mortality.

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

JACC Cardiovasc Interv: 10 Jan 2021; 14:69-78
Nielsen-Kudsk JE, Korsholm K, Damgaard D, Valentin JB, ... Camm AJ, Johnsen SP
JACC Cardiovasc Interv: 10 Jan 2021; 14:69-78 | PMID: 33413867
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Abstract

Biventricular Physiology of Iatrogenic Atrial Septal Defects Following Transcatheter Mitral Valve Edge-to-Edge Repair.

Blazek S, Unterhuber M, Rommel KP, von Roeder M, ... Thiele H, Lurz P
Objectives
The study sought to assess the acute hemodynamic effects of iatrogenic atrial septal defect (iASD) closure following transcatheter mitral valve edge-to-edge repair (TMVR).
Background
The potential hemodynamic and clinical consequences of an iASD following TMVR are currently subject to controversial debates.
Methods
In 21 patients with relevant left-to-right shunt flow (50% [IQR: 38% to 60%] of systemic perfusion volume) across an iASD following TMVR, interventional closure was performed with recordings of left ventricular (LV) and right ventricular (RV) pressure-volume loops during iASD occlusion.
Results
iASD occlusion led to a volume shift from the RV (RV end-diastolic volume index: pre 102 [IQR: 80 to 120] ml/m, post 92 [IQR: 70 to 111] ml/m; p < 0.001) to the LV (LV end-diastolic volume index: pre 91 [IQR: 74 to 124] ml/m, post 97 [IQR: 77 to 127] ml/m; p < 0.001) with reduced RV (3.49 [IQR: 2.07 to 3.58] l/min/m vs. 2.68 [IQR: 2.07 to 3.58] l/min/m; p < 0.001) but increased LV cardiac index (2.25 [IQR: 1.80 to 3.28] l/min/m vs. 2.77 [IQR: 1.90 to 3.34] l/min/m; p = 0.039). Although RV end-diastolic pressure decreased (pre 5.0 [IQR: 4.0 to 8.5] mm Hg, post 4.5 [IQR: 3.0 to 8.3] mm Hg; p = 0.024), LV end-diastolic pressure remained unchanged (pre 11.0 [IQR: 9.5 to 14.0] mm Hg, post 13.0 [IQR: 9.0 to 15.5] mm Hg; p = 0.142). LV transmural pressure increased (7.0 [IQR: 4.0 to 11.0] mm Hg vs. 11.0 [IQR: 7.0 to 15.0] mm Hg; p = 0.001) and LV eccentricity index decreased (p < 0.001). The change in LV transmural pressure correlated significantly with the change in LV-to-RV end-diastolic volume ratio (r = 0.674; p = 0.018). Right heart failure symptoms declined at 1-month follow-up (71% vs. 35%; p = 0.003) as did New York Heart Association functional class (≥III: 48% vs. 25%; p < 0.001).
Conclusions
iASD closure following TMVR leads to a volume shift from the RV to the LV with reduced pulmonary but increased systemic cardiac index and with favorable biventricular interaction at maintained LV filling pressure, resulting in a decline in heart failure symptoms at 1-month follow-up.

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

JACC Cardiovasc Interv: 10 Jan 2021; 14:54-66
Blazek S, Unterhuber M, Rommel KP, von Roeder M, ... Thiele H, Lurz P
JACC Cardiovasc Interv: 10 Jan 2021; 14:54-66 | PMID: 33413865
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Abstract

Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes.

Davidson CJ, Lim DS, Smith RL, Kodali SK, ... Gray WA,
Objectives
The study reports for the first time the 30-day outcomes of the first U.S. study with the Cardioband tricuspid valve reconstruction system for the treatment of functional tricuspid regurgitation (TR).
Background
Increasing severity of TR is associated with progressively higher morbidity and mortality; however, treatment options for isolated significant disease are limited.
Methods
In this single-arm, multicenter, prospective Food and Drug Administration-approved early feasibility study (EFS), 30 patients with severe or greater symptomatic functional TR were enrolled who were deemed candidates for transcatheter tricuspid repair with the Cardioband tricuspid system by the local heart team and multidisciplinary screening committee.
Results
The mean patient age was 77 years, 80% were women, 97% had atrial fibrillation, 70% were in New York Heart Association functional class III to IV with mean left ventricular ejection fraction of 58%, and 27% had severe, 20% massive, and 53% torrential TR. Device success was 93% and all patients were alive at 30 days. Between baseline and 30 days, septolateral tricuspid annular diameter was reduced by 13% (p < 0.001), 85% of patients had ≥1 grade TR reduction and 44% had ≤moderate TR, 75% were in New York Heart Association functional class I to II (p < 0.001), and overall Kansas City Cardiomyopathy Questionnaire score improved by 16 points (p < 0.001).
Conclusions
In patients with severe symptomatic functional TR, this is the first study in the United States with the Cardioband tricuspid system for direct transcatheter annular reduction. This early feasibility study demonstrates high procedural feasibility with no 30-day mortality. There is significant reduction of functional TR with clinically significant improvements in functional status and quality of life. (Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study; NCT03382457).

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

JACC Cardiovasc Interv: 10 Jan 2021; 14:41-50
Davidson CJ, Lim DS, Smith RL, Kodali SK, ... Gray WA,
JACC Cardiovasc Interv: 10 Jan 2021; 14:41-50 | PMID: 33413863
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Abstract

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

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

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

JACC Cardiovasc Interv: 03 Jan 2021; epub ahead of print
Sista AK, Horowitz JM, Tapson VF, Rosenberg M, ... Benenati JF, EXTRACT-PE Investigators
JACC Cardiovasc Interv: 03 Jan 2021; epub ahead of print | PMID: 33454291
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Abstract

Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial.

Cortese B, Di Palma G, Guimaraes MG, Piraino D, ... Zambelli G, Alfonso F
Objectives
This study sought to compare the performance of a novel drug-coated balloon (DCB) (Elutax SV, Aachen Resonance, Germany), with an everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in patients with de novo lesions.
Background
Small vessel coronary artery disease (SVD) represents one of the most attractive fields of application for DCB. To date, several devices have been compared with drug-eluting stents in this setting, with different outcomes.
Methods
The PICCOLETO II (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment) trial was an international, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo SVD lesions were randomized to DCB or EES. Primary study endpoint was in-lesion late lumen loss (LLL) at 6 months (independent core laboratory), with the noninferiority between the 2 arms hypothesized. Secondary endpoints were minimal lumen diameter, percent diameter stenosis at angiographic follow-up, and the occurrence of major adverse cardiac events at 12 months.
Results
Between May 2015 and May 2018, a total of 232 patients were enrolled at 5 centers. After a median of 189 (interquartile range: 160 to 202) days, in-lesion LLL was significantly lower in the DCB group (0.04 vs. 0.17 mm; p = 0.001 for noninferiority; p = 0.03 for superiority). Percent diameter stenosis and minimal lumen diameter were not significantly different. At 12-month clinical follow-up, major adverse cardiac events occurred in 7.5% of the DES group and in 5.6% of the DCB group (p = 0.55). There was a numerically higher incidence of spontaneous myocardial infarction (4.7% vs. 1.9%; p = 0.23) and vessel thrombosis (1.8% vs. 0%; p = 0.15) in the DES arm.
Conclusions
In this multicenter randomized clinical trial in patients with de novo SVD lesions, a new-generation DCB was found superior to EES in terms of LLL as the angiographic pattern and comparable in terms of clinical outcome. (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment [PICCOLETO II]; NCT03899818).

Copyright © 2020. Published by Elsevier Inc.

JACC Cardiovasc Interv: 27 Dec 2020; 13:2840-2849
Cortese B, Di Palma G, Guimaraes MG, Piraino D, ... Zambelli G, Alfonso F
JACC Cardiovasc Interv: 27 Dec 2020; 13:2840-2849 | PMID: 33248978
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Abstract

12-Month Results From the Unblinded Phase of the RADIANCE-HTN SOLO Trial of Ultrasound Renal Denervation.

Azizi M, Daemen J, Lobo MD, Mahfoud F, ... Kirtane AJ,
Objectives
This study reports the 12-month results of the RADIANCE-HTN (A Study of the ReCor Medical Paradise System in Clinical Hypertension) SOLO trial following unblinding of patients at 6 months.
Background
The blood pressure (BP)-lowering efficacy and safety of endovascular ultrasound renal denervation (RDN) in the absence (2 months) and presence (6 months) of antihypertensive medications were previously reported.
Methods
Patients with daytime ambulatory BP ≥135/85 mm Hg after 4 weeks off medication were randomized to RDN (n = 74) or sham (n = 72) and maintained off medication for 2 months. A standardized medication escalation protocol was instituted between 2 and 5 months (blinded phase). Between 6 and 12 months (unblinded phase), patients received antihypertensive medications at physicians\' discretion. Outcomes at 12 months included medication burden, change in daytime ambulatory systolic BP (dASBP) and office or home systolic BP (SBP), visit-to-visit variability in SBP, and safety.
Results
Sixty-five of 74 RDN patients and 67 of 72 sham patients had 12-month dASBP measurements. The proportion of patients on ≥2 medications (27.7% vs. 44.8%; p = 0.041), the number of medications (0 vs. 1.4; p = 0.015), and defined daily dose (1.4 vs. 2.2; p = 0.007) were less with RDN versus sham. The decrease in dASBP from baseline in the RDN group (-16.5 ± 12.9 mm Hg) remained stable at 12 months. The RDN versus sham adjusted difference at 12 months was -2.3 mm Hg (95% confidence interval [CI]: -5.9 to 1.3 mm Hg; p = 0.201) for dASBP, -6.3 mm Hg (95% CI: -11.1 to -1.5 mm Hg; p = 0.010) for office SBP, and -3.4 mm Hg (95% CI: -6.9 to 0.1 mm Hg; p = 0.062) for home SBP. Visit-to-visit variability in SBP was smaller in the RDN group. No renal artery injury was detected on computed tomographic or magnetic resonance angiography.
Conclusions
Despite unblinding, the BP-lowering effect of RDN was maintained at 12 months with fewer prescribed medications compared with sham.

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

JACC Cardiovasc Interv: 27 Dec 2020; 13:2922-2933
Azizi M, Daemen J, Lobo MD, Mahfoud F, ... Kirtane AJ,
JACC Cardiovasc Interv: 27 Dec 2020; 13:2922-2933 | PMID: 33357531
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Abstract

Predictors of Underutilization of Medical Therapy in Patients Undergoing Endovascular Revascularization for Peripheral Artery Disease.

Altin SE, Castro-Dominguez YS, Kennedy KF, Orion KC, ... Abbott JD, Aronow HD
Objectives
The aim of this study was to explore discharge prescription rates of guideline-directed medical therapy (GDMT), defined as aggregate antiplatelet agent, statin, and ACE inhibitor or angiotensin receptor blocker use after endovascular lower extremity (LE) peripheral vascular intervention.
Background
Little is known about contemporary GDMT prescription following LE PVI.
Methods
Sex, age, and comorbid conditions were related to discharge GDMT prescription among patients undergoing LE PVI for symptomatic peripheral artery disease in the 2014-2018 Vascular Study Group of New England Vascular Quality Initiative. Multivariate logistic regression was used to identify independent predictors of discharge GDMT prescription.
Results
Among 12,316 patients, only 47.4% (n = 5,844) were discharged on GDMT after LE PVI. Most patients were discharged on antiplatelet agents (95.2%), with statins (83.5%) and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (55.8%) prescribed less often. A higher proportion of patients were on Class 1 guideline-recommended therapy with antiplatelet agents and statins (80.5%). In multivariate analysis, female sex, older age, end-stage renal disease, chronic limb-threatening ischemia, and congestive heart failure were negative predictors of discharge GDMT prescription, while hypertension, diabetes, coronary artery disease, and prior LE PVI or bypass were positive predictors.
Conclusions
Fewer than one-half of patients undergoing LE PVI are discharged on appropriate GDMT. As expected, traditional atherosclerotic risk factors and measures of greater atherosclerotic disease burden were associated with a greater likelihood of GDMT prescription. However, women and patients with the highest risk for atherothrombosis and limb loss were least likely to be prescribed these agents. Provider- and patient-directed educational efforts are needed to close these treatment gaps.

Published by Elsevier Inc.

JACC Cardiovasc Interv: 27 Dec 2020; 13:2911-2918
Altin SE, Castro-Dominguez YS, Kennedy KF, Orion KC, ... Abbott JD, Aronow HD
JACC Cardiovasc Interv: 27 Dec 2020; 13:2911-2918 | PMID: 33357529
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Abstract

Superior Vena Cava Syndrome.

Azizi AH, Shafi I, Shah N, Rosenfield K, ... Sista A, Bashir R

Superior vena cava (SVC) syndrome comprises a constellation of clinical signs and symptoms caused by obstruction of blood flow through the SVC. The management of patients with life-threatening SVC syndrome is evolving from radiation therapy to endovascular therapy as the first-line treatment. There is a paucity of data and societal guidelines with regard to the management of SVC syndrome. This paper aims to update the practicing interventionalists with the contemporary and the evolving therapeutic approach to SVC syndrome. In addition, the review will focus on endovascular techniques, including catheter-directed thrombolysis, angioplasty, and stenting, and their associated complications.

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

JACC Cardiovasc Interv: 27 Dec 2020; 13:2896-2910
Azizi AH, Shafi I, Shah N, Rosenfield K, ... Sista A, Bashir R
JACC Cardiovasc Interv: 27 Dec 2020; 13:2896-2910 | PMID: 33357528
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Abstract

Prognostic Impact of High-Sensitivity C-Reactive Protein in Patients Undergoing Percutaneous Coronary Intervention According to BMI.

Beyhoff N, Cao D, Mehran R, Dangas G, ... Sharma SK, Kini A
Objectives
The aim of this study was to determine the prevalence and prognostic implications of elevated high-sensitivity C-reactive protein (hsCRP) in patients undergoing percutaneous coronary intervention (PCI) according to body mass index (BMI).
Background
Whereas elevated hsCRP predicts adverse clinical outcome after PCI in the general population, the impact of BMI on its prognostic utility remains unclear.
Methods
Data from 14,140 patients who underwent PCI between January 2009 and June 2017 at a large tertiary care center were analyzed. Patients were divided into 4 BMI categories: normal (BMI 18.5 to <25 kg/m, n = 2,808), overweight (BMI 25 to <30 kg/m, n = 6,015), obese (BMI 30 to <35 kg/m, n = 3,490), and severely obese (BMI ≥35 kg/m, n = 1,827). Elevated hsCRP was defined as >3 mg/l. The primary endpoint of interest was the occurrence of major adverse cardiac events (MACE; defined as death, myocardial infarction, or target vessel revascularization) within 1 year after PCI.
Results
Elevated hsCRP was present in 18.9%, 23.6%, 33.3%, and 47.7% of the normal, overweight, obese, and severely obese groups, respectively. MACE rates were consistently higher in patients with elevated hsCRP across all BMI categories (normal, 13.4% vs. 8.3%; overweight, 11.2% vs. 7.2%; obese, 10.6% vs. 7.5%; severely obese, 11.9% vs. 6.5%; p < 0.01 for all). After multivariate adjustment, hsCRP elevation remained significantly associated with MACE independent of BMI (hazard ratios: normal, 1.43 [95% confidence interval: 1.04 to 1.95]; overweight, 1.56 [95% confidence interval: 1.21 to 1.88]; obese, 1.40 [95% confidence interval: 1.06 to 1.84]; severely obese, 1.92 [95% confidence interval: 1.35 to 2.75]; p < 0.05 for all).
Conclusions
Among patients undergoing PCI, the prevalence of hsCRP elevation progressively increased with higher BMI. Measurement of hsCRP facilitates prognostic risk assessment for adverse outcome after PCI across a broad range of BMI.

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

JACC Cardiovasc Interv: 27 Dec 2020; 13:2882-2892
Beyhoff N, Cao D, Mehran R, Dangas G, ... Sharma SK, Kini A
JACC Cardiovasc Interv: 27 Dec 2020; 13:2882-2892 | PMID: 33357526
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Abstract

Target Lesion Failure With Current Drug-Eluting Stents: Evidence From a Comprehensive Network Meta-Analysis.

Taglieri N, Bruno AG, Ghetti G, Marrozzini C, ... Galié N, Palmerini T
Objectives
The aim of this study was to investigate the efficacy and safety of currently used drug-eluting stents (DES).
Background
Head-to-head comparisons among newer DES have shown conflicting results.
Methods
For this network meta-analysis, randomized controlled trials comparing different types of currently used DES were searched in PubMed, Scopus, and proceedings of international meetings. The primary endpoint was target lesion failure (TLF) at 1 year and at long-term follow-up.
Results
Seventy-seven trials with 99,039 patients were selected for this network meta-analysis. Among the 10 DES included in the meta-analysis, 4 received the most extensive investigation: Orsiro, XIENCE, Nobori/BioMatrix, and Resolute. At 1 year, the Orsiro stent was associated with lower rates of TLF compared with XIENCE (odds ratio [OR]: 0.84; 95% confidence interval [CI]: 0.71 to 0.98; p = 0.03), Resolute (OR: 0.81; 95% CI: 0.68 to 0.95; p = 0.01), and Nobori/BioMatrix (OR: 0.81; 95% CI: 0.67 to 0.98; p = 0.03). Orsiro had the highest probability to be the best (70.8%), with a surface under the cumulative ranking curve value of 95.9%. However, after a median follow-up period of 50 months (range: 24 to 60 months), no significant difference was apparent in the rates of TLF between any DES, although Orsiro still ranked as the best stent (58.6% probability to be the best). In addition, Orsiro had a lower rate of long-term definite stent thrombosis compared with Nobori/BioMatrix (OR: 0.60; 95% CI: 0.36 to 0.98; p = 0.04) and lower rates of definite and probable stent thrombosis compared with Resolute (OR: 0.66; 95% CI: 0.45 to 0.99; p = 0.04). No differences in cardiac mortality between any DES were observed.
Conclusions
Orsiro is associated with a lower 1-year rate of TLF compared with XIENCE, Resolute, and Nobori/BioMatrix but with an attenuation of the efficacy signal at long-term follow-up.

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

JACC Cardiovasc Interv: 27 Dec 2020; 13:2868-2878
Taglieri N, Bruno AG, Ghetti G, Marrozzini C, ... Galié N, Palmerini T
JACC Cardiovasc Interv: 27 Dec 2020; 13:2868-2878 | PMID: 33357524
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Abstract

Pediatric/Congenital Cardiac Catheterization Quality: An Analysis of Existing Metrics.

O\'Byrne ML, Huang J, Asztalos I, Smith CL, ... Rome JJ, Glatz AC
Objectives
The aim of this study was to enumerate and categorize quality metrics relevant to the pediatric/congenital cardiac catheterization laboratory (PCCL).
Background
Diagnostic and interventional catheterization procedures are an increasingly important part of the care of young patients with cardiac disease. Measurement of the performance of PCCL programs in a stringent and consistent fashion is a crucial step toward improving outcomes. To the best of our knowledge, a systematic evaluation of current quality metrics in PCCL has not been performed previously.
Methods
Potential metrics were evaluated by: 1) a systematic review of peer-reviewed research; 2) a review of metrics from organizations interested in quality improvement, patient safety, and/or PCCL programs; and 3) a survey of U.S. PCCL cardiologists. Collected metrics were grouped on 2 dimensions: 1) Institute of Medicine domains; and 2) the Donabedian structure/process/outcome framework. Survey responses were dichotomized between favorable and unfavorable responses and then compared within and between categories.
Results
In the systematic review, 6 metrics were identified (from 9 publications), all focused on safety either as an outcome (adverse events [AEs], mortality, and failure to rescue along with radiation exposure) or as a structure (procedure volume or operator experience). Four organizations measure quality metrics of PCCL programs, of which only 1 publicly reports data. For the survey, 229 cardiologists from 118 hospital programs responded (66% of individuals and 72% of hospital programs). The highest favorable ratings were for safety metrics (p < 0.001), of which major AEs, failure to rescue, and procedure-specific AEs had the highest ratings. Of respondents, 67% stated that current risk adjustment were not effective. Favorability ratings for hospital characteristics, PCCL characteristics, and quality improvement processes were significantly lower than for safety and less consistent within categories.
Conclusions
There is a limited number of PCCL quality metrics, primarily focused on safety. Confidence in current risk adjustment methodology is low. The knowledge gaps identified should guide future research in the development of new quality metrics.

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

JACC Cardiovasc Interv: 27 Dec 2020; 13:2853-2864
O'Byrne ML, Huang J, Asztalos I, Smith CL, ... Rome JJ, Glatz AC
JACC Cardiovasc Interv: 27 Dec 2020; 13:2853-2864 | PMID: 33357522
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Abstract

Long-Term Outcomes After PCI or CABG for Left Main Coronary Artery Disease According to Lesion Location.

Hyun J, Kim JH, Jeong Y, Choe K, ... Park DW,
Objectives
The aim of this study was to investigate the impact of lesion site (ostial or shaft vs. distal bifurcation) on long-term outcomes after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for left main coronary artery (LMCA) disease.
Background
Long-term comparative data after PCI and CABG for LMCA disease according to lesion site are limited.
Methods
Patients from the MAIN-COMPARE (Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty Versus Surgical Revascularization) registry were analyzed, comparing adverse outcomes (all-cause mortality [a composite outcome of death, Q-wave myocardial infarction, or stroke] and target vessel revascularization) between PCI and CABG according to LMCA lesion location during a median follow-up period of 12.0 years.
Results
In overall population, the adjusted risks for death and serious composite outcome were higher after PCI than after CABG for distal bifurcation disease, which was mainly separated beyond 5 years. These outcomes were not different for ostial or shaft disease. When comparing drug-eluting stents (DES) and CABG, the adjusted risks for death and serious composite outcome progressively diverged beyond 5 years after DES compared with CABG for distal bifurcation disease (death: hazard ratio: 1.78; 95% confidence interval: 1.22 to 2.59; composite outcome: hazard ratio: 1.94; 95% confidence interval: 1.35 to 2.79). This difference was driven mainly by PCI with a 2-stent technique for distal bifurcation. In contrast, the adjusted risks for these outcomes were similar between DES and CABG for ostial or shaft disease.
Conclusions
Among patients with distal LMCA bifurcation disease, CABG showed lower mortality and serious composite outcome rates compared with DES beyond 5 years. However, there were no between-group differences in these outcomes among patients with ostial or shaft LMCA disease.

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

JACC Cardiovasc Interv: 27 Dec 2020; 13:2825-2836
Hyun J, Kim JH, Jeong Y, Choe K, ... Park DW,
JACC Cardiovasc Interv: 27 Dec 2020; 13:2825-2836 | PMID: 33357520
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Abstract

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

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

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

JACC Cardiovasc Interv: 16 Dec 2020; epub ahead of print
Brinkert M, Mangner N, Moriyama N, Keller LS, ... Linke A, Toggweiler S
JACC Cardiovasc Interv: 16 Dec 2020; epub ahead of print | PMID: 33358653
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Abstract

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

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

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

JACC Cardiovasc Interv: 15 Dec 2020; epub ahead of print
van Wiechen MP, Tchétché D, Ooms JF, Hokken TW, ... Dumonteil N, Van Mieghem NM
JACC Cardiovasc Interv: 15 Dec 2020; epub ahead of print | PMID: 33358648
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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: 13 Dec 2020; 13:2806-2810
Klein LW, Dehmer GJ, Anderson HV, Rao SV
JACC Cardiovasc Interv: 13 Dec 2020; 13:2806-2810 | PMID: 33069644
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Abstract

Procedural and Short-Term Results With the New Watchman FLX Left Atrial Appendage Occlusion Device.

Cruz-González I, Korsholm K, Trejo-Velasco B, Thambo JB, ... Schmitz T, Nielsen-Kudsk JE
Objectives
This study sought to report early experience with the new-generation Watchman FLX device (Boston Scientific, Marlborough, Massachusetts).
Background
The new-generation Watchman FLX features a reduced height, improved anchoring and fabric coverage, and a closed distal end. These design modifications aim to simplify implantation, allow full recapture and repositioning, and reduce peridevice leak and device-related thrombosis.
Methods
A total of 165 patients undergoing left atrial appendage (LAA) occlusion (LAAO) with Watchman FLX were enrolled in a prospective, multicenter registry at 12 centers participating in the European limited market release program.
Results
Mean age was 75.4 ± 8.9 years, and CHADS-VASc score 4.4 ± 1.4. A total of 128 patients (77.6%) had a history of major bleeding, including previous intracranial hemorrhage in 55 cases (33.3%). LAA landing zone minimal and maximal mean diameters were 19.1 ± 3.6 mm and 22.3 ± 3.7 mm, and 24.2% of LAA were considered complex by dimensions. Technical success was achieved in all patients. Successful implantation at first attempt was achieved in 129 cases (78.2%), and a second device was required in 6 cases (3.6%). Procedure-related complications occurred in 3 patients (1.8%): 2 access-related (1.2%) and 1 pericardial effusion (0.6%). No peri-procedural strokes, deaths, or device embolizations occurred. Forty-nine patients (29.7%) were discharged with single antiplatelet therapy, 105 (63.6%) on dual antiplatelet, and 11 (6.7%) on anticoagulation. Imaging follow-up displayed just 1 peridevice leak ≥5 mm and 7 cases of device-related thrombosis (4.7%). During a median follow-up of 55 days (interquartile range: 45 to 148 days), there were 6 hemorrhagic complications (4.8%), 1 patient (0.8%) had an ischemic stroke, and 1 (0.8%) died. No late device embolizations occurred.
Conclusions
LAAO with the Watchman FLX is safe and effective in a wide range of LAA morphologies, with a low procedural complication rate, high degree of LAA sealing, and favorable short-term efficacy.

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

JACC Cardiovasc Interv: 13 Dec 2020; 13:2732-2741
Cruz-González I, Korsholm K, Trejo-Velasco B, Thambo JB, ... Schmitz T, Nielsen-Kudsk JE
JACC Cardiovasc Interv: 13 Dec 2020; 13:2732-2741 | PMID: 33189641
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Abstract

Functional and Echocardiographic Improvement After Transcatheter Repair for Tricuspid Regurgitation: A Systematic Review and Pooled Analysis.

Montalto C, Sticchi A, Crimi G, Laricchia A, ... Latib A, Mangieri A
Objectives
The aim of this study was to assess the feasibility, efficacy, and clinical outcomes of transcatheter repair of tricuspid regurgitation (TR) in a pooled analysis of interventional studies.
Background
New percutaneous devices are available to treat severe TR, but the evidence is sparse and limited to smaller cohorts.
Methods
Several electronic databases were searched for interventional studies involving percutaneous repair of TR. Devices used were the Cardioband, FORMA, MitraClip, PASCAL, and Trialign. Outcomes included in the final analysis were successful implantation, residual severe TR, post-procedural New York Heart Association (NYHA) functional class III or IV, 6-min walk distance, and echocardiographic parameters. Subgroup and meta-regression analysis were performed to further explore residual heterogeneity.
Results
Seven studies and 454 patients undergoing transcatheter tricuspid valve repair were included in the pooled analysis; 95% of patients had at least severe TR, and 91% were in NYHA functional class III or IV. Successful implantation was achieved in 86% of patients. At the longest follow-up available (weighted mean 265 days), 9% had died. Compared with baseline, a significantly lower proportion of patients had at least severe TR (relative risk: 0.38; 95% confidence interval: 0.20 to 0.70; p = 0.004) and were in NYHA functional class III or IV (relative risk: 0.23; 95% confidence interval: 0.20 to 0.30; p < 0.001). Patients also experienced increases in 6-min walk distance (mean difference +64.6 m; p < 0.001) and significant reductions in tricuspid valve annular diameter (mean difference -3 mm; p < 0.001), while left and right ventricular function did not change significantly.
Conclusions
A strategy of transcatheter repair for severe TR appears to be feasible, effective, and associated with improved clinical outcomes at mid-term follow-up.

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

JACC Cardiovasc Interv: 13 Dec 2020; 13:2719-2729
Montalto C, Sticchi A, Crimi G, Laricchia A, ... Latib A, Mangieri A
JACC Cardiovasc Interv: 13 Dec 2020; 13:2719-2729 | PMID: 33189640
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Abstract

Impact of COPD on Outcomes After MitraClip for Secondary Mitral Regurgitation: The COAPT Trial.

Saxon JT, Cohen DJ, Chhatriwalla AK, Kotinkaduwa LN, ... Arnold SV, Stone GW
Objectives
The aim of this study was to examine the relationship between chronic obstructive pulmonary disease (COPD) and outcomes after transcatheter mitral valve repair (TMVr) for severe secondary mitral regurgitation.
Background
TMVr with the MitraClip improves clinical and health-status outcomes in patients with heart failure and severe (3+ to 4+) secondary mitral regurgitation. Whether these benefits are modified by COPD is unknown.
Methods
COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) was an open-label, multicenter, randomized trial of TMVr plus guideline-directed medical therapy (GDMT) versus GDMT alone. Patients on corticosteroids or continuous oxygen were excluded. Multivariable models were used to examine the associations of COPD with mortality, heart failure hospitalization (HFH), and health status and to test whether COPD modified the benefit of TMVr compared with GDMT.
Results
Among 614 patients, 143 (23.2%) had COPD. Among patients treated with TMVr, unadjusted analyses demonstrated increased 2-year mortality in those with COPD (hazard ratio [HR]: 2.08; 95% confidence interval [CI]: 1.33 to 3.26), but this association was attenuated after risk adjustment (adjusted HR: 1.48; 95% CI: 0.87 to 2.52). Although TMVr led to reduced 2-year mortality among patients without COPD (adjusted HR: 0.47; 95% CI: 0.33 to 0.67), for patients with COPD, 2-year all-cause mortality was similar after TMVr versus GDMT alone (adjusted HR: 0.94; 95% CI: 0.54 to 1.65; p = 0.04), findings that reflect offsetting effects on cardiovascular and noncardiovascular mortality. In contrast, TMVr reduced HFH (adjusted HR: 0.48 [95% CI: 0.28 to 0.83] vs. 0.46 [95% CI: 0.34 to 0.63]; p = 0.89) and improved both generic and disease-specific health status to a similar extent compared with GDMT alone in patients with and without COPD (p >0.30 for all scales).
Conclusions
In the COAPT trial, COPD was associated with attenuation of the survival benefit of TMVr versus GDMT compared with patients without COPD. However, the benefits of TMVr on both HFH and health status were similar regardless of COPD. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079).

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

JACC Cardiovasc Interv: 13 Dec 2020; 13:2795-2803
Saxon JT, Cohen DJ, Chhatriwalla AK, Kotinkaduwa LN, ... Arnold SV, Stone GW
JACC Cardiovasc Interv: 13 Dec 2020; 13:2795-2803 | PMID: 33303119
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Abstract

Transcatheter Treatment of Residual Significant Mitral Regurgitation Following TAVR: A Multicenter Registry.

Witberg G, Codner P, Landes U, Brabanti M, ... Webb JG, Kornowski R
Objectives
The aim of this study was to describe baseline characteristics, and periprocedural and mid-term outcomes of patients undergoing transcatheter mitral valve interventions post-transcatheter aortic valve replacement (TAVR) and examine their clinical benefit.
Background
The optimal management of residual mitral regurgitation (MR) post-TAVR is challenging.
Methods
This was an international registry of 23 TAVR centers.
Results
In total, 106 of 24,178 patients (0.43%) underwent mitral interventions post-TAVR (100 staged, 6 concomitant), most commonly percutaneous edge-to-edge mitral valve repair (PMVR). The median interval post-TAVR was 164 days. Mean age was 79.5 ± 7.2 years, MR was >moderate in 97.2%, technical success was 99.1%, and 30-day device success rate was 88.7%. There were 18 periprocedural complications (16.9%) including 4 deaths. During a median follow-up of 464 days, the cumulative risk for 3-year mortality was 29.0%. MR grade and New York Heart Association (NYHA) functional class improved dramatically; at 1 year, MR was moderate or less in 90.9% of patients (mild or less in 69.1%), and 85.9% of patients were in NYHA functional class I/II. Staged PMVR was associated with lower mortality versus medical treatment (57.5% vs. 30.8%) in a propensity-matched cohort (n = 156), but this was not statistically significant (hazard ratio: 1.75; p = 0.05).
Conclusions
For patients who continue to have significant MR, remain symptomatic post-TAVR, and are anatomically suitable for transcatheter interventions, these interventions are feasible, safe, and associated with significant improvement in MR grade and NYHA functional class. These results apply mainly to PMVR. A staged PMVR strategy was associated with markedly lower mortality, but this was not statistically significant. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter Valve Registry [AMTRAC]; NCT04031274).

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

JACC Cardiovasc Interv: 13 Dec 2020; 13:2782-2791
Witberg G, Codner P, Landes U, Brabanti M, ... Webb JG, Kornowski R
JACC Cardiovasc Interv: 13 Dec 2020; 13:2782-2791 | PMID: 33303117
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Abstract

German Multicenter Experience With a New Leaflet-Based Transcatheter Mitral Valve Repair System for Mitral Regurgitation.

Mauri V, Besler C, Riebisch M, Al-Hammadi O, ... Lurz P, Pfister R
Objectives
The aim of this study was to investigate the procedural and short-term safety and efficacy of a new leaflet-based transcatheter mitral valve repair system.
Background
The PASCAL repair system has been recently approved for percutaneous treatment of mitral regurgitation (MR). Novel characteristics are broad paddles positioned around a central spacer and the ability for independent leaflet capture.
Methods
Procedural and 30-day outcomes were investigated in the first 309 patients with symptomatic MR 3+/4+ treated with the PASCAL repair system at 10 sites. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE).
Results
Among the 309 patients (mean age 77 ± 10 years, 42% women, mean European System for Cardiac Operative Risk Evaluation II score 5.8 ± 4.5%) included in this study, MR etiology was degenerative in 33%, functional in 52%, and mixed in 16%. Eighty-six percent of patients were in New York Heart Association functional class III or IV. The technical success rate was 96%. Of 308 patients discharged alive, MR was ≤2+ in 93.5%. At 30 days, the MAE rate was 4.1%, with an estimated all-cause mortality rate of 2.0%, and 72% of patients were in New York Heart Association functional class ≤II (p < 0.001). Rates of device success and CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) trial-defined clinical success were 81.9% and 86.9%, respectively. Single-leaflet device attachment occurred in 7 patients (2.3%).
Conclusions
Mitral valve repair with the PASCAL system in the early post-approval phase was effective and safe, with high procedural success rates and low rates of MAE. MR was significantly reduced, accompanied by significant improvement in functional status.

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

JACC Cardiovasc Interv: 13 Dec 2020; 13:2769-2778
Mauri V, Besler C, Riebisch M, Al-Hammadi O, ... Lurz P, Pfister R
JACC Cardiovasc Interv: 13 Dec 2020; 13:2769-2778 | PMID: 33303115
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Abstract

Single-Barrel, Double-Barrel, and Fenestrated Endografts to Facilitate Transcatheter Pulmonary Valve Replacement in Large RVOT.

Kamioka N, Babaliaros VC, Lisko JC, Sahu A, ... Greenbaum AB, Kim DW
Objectives
The aim of this study was to test the hypothesis that narrowing the landing zone using commercially available endografts would enable transcatheter pulmonary valve replacement (TPVR) using commercially available transcatheter heart valves.
Background
TPVR is challenging in an outsized native or patch-repaired right ventricular outflow tract (RVOT). Downsizing the RVOT for TPVR is currently possible only using investigational devices. In patients ineligible because of excessive RVOT size, TPVR landing zones were created using commercially available endografts.
Methods
Consecutive patients with native or patch-repaired RVOTs and high or prohibitive surgical risk were reviewed, and this report describes the authors\' experience with endograft-facilitated TPVR (EF-TPVR) offered to patients ineligible for investigational or commercial devices. All EF-TPVR patients were surgery ineligible, with symptomatic, severe pulmonary insufficiency, enlarged RVOTs, and severe right ventricular (RV) enlargement (>150 ml/m). TPVR and surgical pulmonary valve replacement (SPVR) were compared in patients with less severe RV enlargement.
Results
Fourteen patients had large RVOTs unsuitable for conventional TPVR; 6 patients (1 surgery ineligible) received investigational devices, and 8 otherwise ineligible patients underwent compassionate EF-TPVR (n = 5 with tetralogy of Fallot). Three strategies were applied on the basis of progressively larger RVOT size: single-barrel, in situ fenestrated, and double-barrel endografts as required to anchor 1 (single-barrel and fenestrated) or 2 (double-barrel) transcatheter heart valves. All were technically successful, without procedure-related, 30-day, or in-hospital deaths. Two late complications (stent obstruction and embolization) were treated percutaneously. One patient died of ventricular tachycardia 36 days after EF-TPVR. Compared with 48 SPVRs, RV enlargement was greater, but 30-day and 1-year mortality and readmission were no different. The mean transvalvular pressure gradient was lower after EF-TPVR (3.8 ± 0.8 mm Hg vs. 10.7 ± 4.1 mm Hg; p < 0.001; 30 days). More than mild pulmonary insufficiency was equivalent in both (EF-TPVR 0.0% [n = 0 of 8] vs. SPVR 4.3% [n = 1 of 43]; p = 1.00; 30 days).
Conclusions
EF-TPVR may be an alternative for patients with pulmonic insufficiency and enlarged RVOTs ineligible for other therapies.

Copyright © 2020 American College of Cardiology Foundation. All rights reserved.

JACC Cardiovasc Interv: 13 Dec 2020; 13:2755-2765
Kamioka N, Babaliaros VC, Lisko JC, Sahu A, ... Greenbaum AB, Kim DW
JACC Cardiovasc Interv: 13 Dec 2020; 13:2755-2765 | PMID: 33303113
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Impact:
Abstract

Patent Foramen Ovale Attributable Cryptogenic Embolism With Thrombophilia Has Higher Risk for Recurrence and Responds to Closure.

Liu K, Song B, Palacios IF, Inglessis-Azuaje I, ... Buonanno FS, Ning M
Objectives
The aim of this study was to investigate the effect of management on the risk for recurrent events among patients with cryptogenic ischemic stroke or transient ischemic attack.
Background
The combination of patent foramen ovale (PFO) and hypercoagulability may greatly increase the risk for paradoxical embolism. However, previous randomized controlled trials evaluating the efficacy of PFO closure excluded these potential high-risk patients.
Methods
Patients diagnosed with PFO attributable cryptogenic embolism were prospectively, without randomization, recruited from January 2005 to March 2018. The relationship between thrombophilia and recurrent events was evaluated in overall patients. Multivariate Cox regression was conducted to assess the relative risk for recurrence in PFO closure and medical therapy groups.
Results
A total of 591 patients with cryptogenic embolism with PFO were identified. The median duration of follow-up was 53 months, and thrombophilia significantly increased the risk for recurrent events (hazard ratio [HR]: 1.85; 95% confidence interval [CI]: 1.09 to 3.16; p = 0.024). PFO closure was superior to medical therapy in overall patients (HR: 0.16; 95% CI: 0.09 to 0.30; p < 0.001). Of the 134 patients (22.7%) with thrombophilia, there was a difference in the risk for recurrence events between the PFO closure (6 of 89) and medical therapy (15 of 45) groups (HR: 0.25; 95% CI: 0.08 to 0.74; p = 0.012). There was no potential heterogeneity in the further subgroup analysis.
Conclusions
Patients with cryptogenic stroke with PFO and hypercoagulable state had increased risk for recurrent stroke or transient ischemic attack. PFO closure provided a lower risk for recurrent events compared with medical therapy alone.

Copyright © 2020. Published by Elsevier Inc.

JACC Cardiovasc Interv: 13 Dec 2020; 13:2745-2752
Liu K, Song B, Palacios IF, Inglessis-Azuaje I, ... Buonanno FS, Ning M
JACC Cardiovasc Interv: 13 Dec 2020; 13:2745-2752 | PMID: 33303111
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Impact:
Abstract

Cardiopulmonary Hemodynamic Profile Predicts Mortality After Transcatheter Tricuspid Valve Repair in Chronic Heart Failure.

Stocker TJ, Hertell H, Orban M, Braun D, ... Lurz P, Hausleiter J
Objectives
This study was designed to assess hemodynamic changes in response to transcatheter tricuspid valve edge-to-edge repair (TTVR) and to identify hemodynamic predictors associated with mortality.
Background
Severe tricuspid regurgitation (TR) is associated with high mortality. TTVR effectively alleviates heart failure symptoms, but comprehensive hemodynamic characterization of patients undergoing TTVR is currently lacking.
Methods
This international, multicenter study included 236 patients undergoing TTVR. Data from clinical assessment, echocardiography, intraprocedural right heart catheterization, and noninvasive cardiac output measurement were analyzed. Hemodynamic predictors for mortality were identified using linear Cox regression analysis and were used for stratification of patients with subsequent analysis of survival time.
Results
Patients (median age 78 years, 53% women) were symptomatic (89% in New York Heart Association functional class III or IV) because of severe TR (grade ≥3+ in 100%). TTVR significantly reduced TR at discharge (grade ≥3+ in 16%; p < 0.001), with a corresponding 19% reduction of the right atrial v wave (21 mm Hg vs. 16 mm Hg; p < 0.001) and an improvement in cardiac output (from 3.5 to 4.0 l/min; p < 0.01). Invasive mean pulmonary artery pressure, transpulmonary gradient, pulmonary vascular resistance, and right ventricular stroke work were significant predictors of 1-year mortality (p < 0.05 for all). Hemodynamic stratification by mean pulmonary artery pressure and transpulmonary gradient best predicted 1-year survival (p < 0.001). Although patients with pre-capillary dominant pulmonary hypertension showed an unfavorable prognosis (1-year survival 38%), patients without or with post-capillary pulmonary hypertension had favorable outcome (1-year survival 92% or 78%, respectively).
Conclusions
Invasive assessment of cardiopulmonary hemodynamic status predicts survival after TTVR. Invasive hemodynamic characterization may help identify patients profiting most from TTVR.

Copyright © 2020. Published by Elsevier Inc.

JACC Cardiovasc Interv: 02 Dec 2020; epub ahead of print
Stocker TJ, Hertell H, Orban M, Braun D, ... Lurz P, Hausleiter J
JACC Cardiovasc Interv: 02 Dec 2020; epub ahead of print | PMID: 33309317
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Abstract

COAPT-Like Profile Predicts Long-Term Outcomes in Patients With Secondary Mitral Regurgitation Undergoing MitraClip Implantation.

Adamo M, Fiorelli F, Melica B, D\'Ortona R, ... Petronio AS, Metra M
Objectives
The aim of this study was to evaluate whether fulfilling COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) criteria identifies patients with better outcomes after MitraClip treatment for secondary mitral regurgitation (SMR).
Background
To date, COAPT is the only trial showing a prognostic benefit of MitraClip implantation compared with conservative management.
Methods
Three hundred four patients with SMR undergoing MitraClip placement in addition to optimal medical therapy at 3 European centers were analyzed. A COAPT-like profile was defined as absence of all the following criteria: severe left ventricular impairment, moderate to severe right ventricular dysfunction, severe tricuspid regurgitation, severe pulmonary hypertension, and hemodynamic instability. Freedom from all-cause death and from a composite endpoint (cardiovascular death and heart failure hospitalization) were evaluated at 2- and 5-year follow-up.
Results
A COAPT-like profile was observed in 65% of the population. Compared with non-COAPT-like patients, those fulfilling COAPT criteria had greater survival free from all-cause death and from the composite endpoint at both 2 year (75% vs. 55% and 67% vs. 47%; p < 0.001 for both) and 5-year (49% vs. 25% and 40% vs. 19%; p < 0.001 for both) follow-up. Among the non-COAPT-like patients, similar outcomes were observed in those fulfilling 1 or ≥1 criterion. Left ventricular impairment had a late impact on outcomes, while right ventricular impairment, pulmonary hypertension, and hemodynamic instability had early effects. COAPT-like profile was an independent predictor of long-term outcomes, as well as administration of neurohormonal antagonists, European System for Cardiac Operative Risk Evaluation II score, and previous heart failure hospitalization.
Conclusions
A COAPT-like profile, including specific echocardiographic and clinical criteria, identifies patients with SMR who have a better prognosis after MitraClip implantation.

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

JACC Cardiovasc Interv: 02 Dec 2020; epub ahead of print
Adamo M, Fiorelli F, Melica B, D'Ortona R, ... Petronio AS, Metra M
JACC Cardiovasc Interv: 02 Dec 2020; epub ahead of print | PMID: 33309313
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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
This study 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: 22 Nov 2020; 13:2670-2684
Lee SH, Shin D, Lee JM, Lefieux A, ... Choi SH, Gwon HC
JACC Cardiovasc Interv: 22 Nov 2020; 13:2670-2684 | PMID: 33069650
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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 peri-procedural 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
One-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: 22 Nov 2020; 13:2601-2613
Faroux L, Campelo-Parada F, Munoz-Garcia E, Nombela-Franco L, ... Couture T, Rodés-Cabau J
JACC Cardiovasc Interv: 22 Nov 2020; 13:2601-2613 | PMID: 33069647
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Abstract

Transcatheter Aortic Valve Replacement With Balloon-Expandable Valves: Comparison of SAPIEN 3 Ultra Versus SAPIEN 3.

Rheude T, Pellegrini C, Lutz J, Alvarez-Covarrubias HA, ... Joner M, Xhepa E
Objectives
The aim of this study was to compare outcomes after transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 Ultra (Ultra) and SAPIEN 3 (S3) transcatheter heart valves (THVs).
Background
The latest generation balloon-expandable Ultra THV incorporates new technical features and might improve outcomes following TAVR.
Methods
This registry included all consecutive patients who underwent TAVR with either the Ultra or S3 between January 2014 and January 2020. One-to-one propensity score matching was performed to account for differences in baseline characteristics. In-hospital and 30-day Valve Academic Research Consortium-2-defined outcomes were investigated.
Results
A total of 310 patients (n = 155 Ultra, n = 155 S3) were included. There were no significant differences in baseline characteristics after propensity score matching. Procedures were significantly more often performed under conscious sedation with Ultra compared with S3 (97.4% vs. 71.6%; p < 0.001). Pre-dilatation was more frequent with S3 compared with Ultra (85.2% vs. 42.6%; p < 0.001). In-hospital outcomes, including device success (91.6% vs. 95.5%; p = 0.165), major vascular complications (12.3% vs. 11.0%; p = 0.723), and new pacemaker implantation (5.8% vs. 4.5%; p = 0.608), were comparable between S3 and Ultra patients, respectively. Post-procedural mean transprosthetic gradients (13.2 ± 5.7 mm Hg vs. 13.1 ± 4.7 mm Hg; p = 0.829) and rate of moderate or greater paravalvular leakage (PVL) (1.3% vs. 2.7%; p = 0.414) were comparable, whereas mild PVL was more frequent with S3 compared with Ultra (43.0% vs. 18.7%; p < 0.001).
Conclusions
Device success rates were high with both balloon-expandable THVs, with overall low rates of adverse events up to 30 days after TAVR. Despite a lower frequency of pre-dilatation, significant reduction of mild PVL confirms improved annular sealing properties of the novel Ultra THV.

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

JACC Cardiovasc Interv: 22 Nov 2020; 13:2631-2638
Rheude T, Pellegrini C, Lutz J, Alvarez-Covarrubias HA, ... Joner M, Xhepa E
JACC Cardiovasc Interv: 22 Nov 2020; 13:2631-2638 | PMID: 33129822
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Abstract

Comparisons of Nonhyperemic Pressure Ratios: Predicting Functional Results of Coronary Revascularization Using Longitudinal Vessel Interrogation.

Omori H, Kawase Y, Mizukami T, Tanigaki T, ... Escaned J, Matsuo H
Objectives
The aim of this study was to investigate the accuracy of pre-percutaneous coronary intervention (PCI) predicted nonhyperemic pressure ratios (NHPRs) with actual post-PCI NHPRs and to assess the efficacy of PCI strategy using pre-PCI NHPR pullback.
Background
Predicting the functional results of PCI is feasible using pre-PCI longitudinal vessel interrogation with the instantaneous wave-free ratio (iFR), a pressure-based, adenosine-free NHPR. However, the reliability of novel NHPRs (resting full-cycle ratio [RFR] and diastolic pressure ratio [dPR]) for this purpose remains uncertain.
Methods
In this prospective, multicenter, randomized controlled trial, vessels were randomly assigned to receive pre-PCI iFR, RFR, or dPR pullback (50 vessels each). The pre-PCI predicted NHPRs were compared with actual NHPRs after contemporary PCI using intravascular imaging. The number and the total length of treated lesions were compared between NHPR pullback-guided and angiography-guided strategies.
Results
The predicted NHPRs were strongly correlated with actual NHPRs: iFR, r = 0.83 (95% confidence interval: 0.72 to 0.90; p < 0.001); RFR, r = 0.84 (95% confidence interval: 0.73 to 0.91; p < 0.001), and dPR, r = 0.84 (95% confidence interval: 0.73 to 0.91; p < 0.001). The number and the total length of treated lesions were lower with the NHPR pullback strategy than with the angiography-guided strategy, leading to physiological improvement.
Conclusions
Predicting functional PCI results on the basis of pre-procedural RFR and dPR pullbacks yields similar results to iFR. Compared with an angiography-guided strategy, a pullback-guided PCI strategy with any of the 3 NHPRs reduced the number and the total length of treated lesions. (Study to Examine Correlation Between Predictive Value and Post PCI Value of iFR, RFR and dPR; UMIN000033534).

Copyright © 2020. Published by Elsevier Inc.

JACC Cardiovasc Interv: 22 Nov 2020; 13:2688-2698
Omori H, Kawase Y, Mizukami T, Tanigaki T, ... Escaned J, Matsuo H
JACC Cardiovasc Interv: 22 Nov 2020; 13:2688-2698 | PMID: 33129819
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Abstract

Direct Oral Anticoagulants Versus Vitamin K Antagonists in Patients With Atrial Fibrillation After TAVR.

Kawashima H, Watanabe Y, Hioki H, Kozuma K, ... Hayashida K,
Objectives
The aim of this study was to compare long-term all-cause mortality between direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) after transcatheter aortic valve replacement (TAVR).
Background
The optimal anticoagulant agent for patients with AF after TAVR has not been clarified.
Methods
OCEAN (Optimized Transcatheter Valvular Intervention) is a prospective, multicenter, observational cohort registry comprising 2,588 patients who underwent TAVR between October 2013 and May 2017. Of these, 403 patients (15.6%) with AF on anticoagulant therapy were identified, of whom 227 (56.3%) were prescribed DOACs and 176 (43.7%) were prescribed VKAs. Patients who successfully discharged after TAVR were stratified into DOAC and VKA groups on the basis of the prescription of anticoagulant agents, and the analyses started from discharge.
Results
In total, 33.3% of patients were men. The mean age was 84.4 ± 4.7 years, and the average CHADS-VASc score was 5.1 ± 1.1. The median follow-up duration was 568 days. A multivariate Cox regression model and inverse probability of treatment weighting based on the propensity score demonstrated that the DOAC group was significantly associated with a lower incidence of all-cause mortality compared with the VKA group (10.3% vs. 23.3%; Cox-adjusted hazard ratio: 0.391; 95% confidence interval: 0.204 to 0.749; p = 0.005; and 10.2% vs. 20.6%; inverse probability of treatment weighting-adjusted hazard ratio: 0.531; 95% confidence interval: 0.294 to 0.961; p = 0.036, respectively).
Conclusions
Compared with VKAs, DOACs might be associated with lower long-term all-cause mortality in patients with concomitant AF who are successfully discharged after TAVR. This finding warrants investigation in ongoing prospective randomized trials.

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

JACC Cardiovasc Interv: 22 Nov 2020; 13:2587-2597
Kawashima H, Watanabe Y, Hioki H, Kozuma K, ... Hayashida K,
JACC Cardiovasc Interv: 22 Nov 2020; 13:2587-2597 | PMID: 33129818
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Abstract

Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Prior Mediastinal Radiation.

Elbadawi A, Albaeni A, Elgendy IY, Ogunbayo GO, ... Kapadia SR, Jneid H
Objectives
This study sought to evaluate the trends and outcomes of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) among patients with prior mediastinal radiation from a national database.
Background
There is a paucity of data about the temporal trends and outcomes of TAVR versus SAVR in patients with prior mediastinal radiation.
Methods
The National Inpatient Sample database years 2012 to 2017 was queried for hospitalizations of patients with prior mediastinal radiation who underwent isolated AVR. Using multivariable analysis, the study compared the outcomes of TAVR versus SAVR. The main study outcome was in-hospital mortality.
Results
The final analysis included 3,675 hospitalizations for isolated AVR; of whom 2,170 (59.1%) underwent TAVR and 1,505 (40.9%) underwent isolated SAVR. TAVR was increasingly performed over time (p = 0.01), but there was no significant increase in the rates of utilization of SAVR. The following factors were independently associated with TAVR utilization: older age, chronic lung disease, coronary artery disease, chronic kidney disease, prior cerebrovascular accidents, prior coronary artery bypass grafting, and larger-sized hospitals, while women were less likely to undergo TAVR. Compared with SAVR, TAVR was associated with lower in-hospital mortality (1.2% vs. 2.0%, adjusted odds ratio: 0.27; 95% confidence interval: 0.09 to 0.79; p = 0.02). TAVR was associated with lower rates of acute kidney injury, use of mechanical circulatory support, bleeding and respiratory complications, and shorter length of hospital stay. TAVR was associated with higher rates of pacemaker insertion.
Conclusions
This nationwide observational analysis showed that TAVR is increasingly performed among patients with prior mediastinal radiation. TAVR provides an important treatment option for this difficult patient population with desirable procedural safety when using SAVR as a benchmark.

Published by Elsevier Inc.

JACC Cardiovasc Interv: 22 Nov 2020; 13:2658-2666
Elbadawi A, Albaeni A, Elgendy IY, Ogunbayo GO, ... Kapadia SR, Jneid H
JACC Cardiovasc Interv: 22 Nov 2020; 13:2658-2666 | PMID: 33213751
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Abstract

Transcatheter Versus Rapid-Deployment Aortic Valve Replacement: A Propensity-Matched Analysis From the German Aortic Valve Registry.

Abdel-Wahab M, Fujita B, Frerker C, Bauer T, ... Ensminger S,
Objectives
This study sought to compare patient characteristics, procedural outcomes, and valve hemodynamics of surgical aortic valve replacement (SAVR) with current-generation rapid-deployment valves (RDVs) versus transcatheter aortic valve replacement (TAVR) with current-generation transcatheter heart valves (THVs).
Background
The patient population currently treated with RDVs may have potential similarities with the current TAVR population, but comparative studies in a large patient population remain scarce.
Methods
A total of 16,473 patients who underwent isolated SAVR using current-generation RDVs or isolated transfemoral TAVR with current-generation THVs between 2011 and 2017 were enrolled into the German Aortic Valve Registry. Baseline, procedural, and in-hospital outcome parameters were analyzed for RDVs and THVs before and after 1:1 propensity score matching. Furthermore, RDVs and THVs with similar design characteristics were compared with each other.
Results
A total of 1,743 patients received SAVR with an RDV, whereas 14,730 patients were treated with transfemoral TAVR. Patients treated with TAVR were significantly older and had higher surgical risk scores. Following valve replacement, patients treated with an RDV had a significantly higher rate of disabling stroke (1.7% vs. 1.1%; p = 0.03), need for transfusion of >4 red blood cell units (8.5% vs. 1.4%; p < 0.001), and new onset renal replacement therapy (1.9% vs. 1.2%; p = 0.01), whereas the need for a new permanent pacemaker was lower (8.4% vs. 14.9%; p < 0.001). In-hospital mortality was similar (1.6% vs. 1.8%; p = 0.62). These findings persisted after 1:1 propensity score matching, but in-hospital mortality was significantly higher after RDVs (1.7% vs. 0.6%; p = 0.003). Balloon-expandable (BE) RDVs had significantly lower residual gradients compared with BE-THVs, while self-expanding (SE)-RDVs had significantly higher residual gradients compared with SE-THVs.
Conclusions
In a large all-comers\' registry, TAVR with current-generation THVs was associated with improved in-hospital outcomes compared with SAVR with current-generation RDVs. The pacemaker rate is significantly higher with TAVR. Post-procedural hemodynamic function varied between individual RDVs and THVs.

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

JACC Cardiovasc Interv: 22 Nov 2020; 13:2642-2654
Abdel-Wahab M, Fujita B, Frerker C, Bauer T, ... Ensminger S,
JACC Cardiovasc Interv: 22 Nov 2020; 13:2642-2654 | PMID: 33213749
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Abstract

Risk of Coronary Obstruction Due to Sinus Sequestration in Redo Transcatheter Aortic Valve Replacement.

Ochiai T, Oakley L, Sekhon N, Komatsu I, ... Cheng W, Makkar R
Objectives
The aim of this study was to evaluate the risk of coronary obstruction due to sinus sequestration in redo transcatheter aortic valve replacement (TAVR) using post-TAVR computed tomography (CT).
Background
Little information is available regarding the risk of coronary obstruction due to sinus sequestration in redo TAVR inside a previously implanted TAV.
Methods
Post-TAVR CT of 66 patients who received an Evolut R or Evolut PRO and 345 patients who received a SAPIEN 3 were analyzed. Redo TAVR was considered at risk of coronary obstruction due to sinus sequestration if: 1) the prior TAV commissure level was above sinotubular junction (STJ); and 2) the distance between TAV and STJ was <2.0 mm in each coronary sinus.
Results
In total, 45.5% in the Evolut R/Evolut PRO group and 2.0% in the SAPIEN 3 group had CT-identified risk of sinus sequestration at 1 or both coronary arteries (p < 0.001). CT-identified risk of sinus sequestration was observed in 39.4% for the left coronary artery and 24.2% for the right coronary artery in the Evolut R/Evolut PRO group, while those percentages were 2.0% for the left coronary artery and 0.6% for the right coronary artery in the SAPIEN 3 group. In a coronary-level analysis, overlaps between the first TAV commissural posts and coronary ostium were observed in 45.2% in the Evolut R/Evolut PRO group and 11.1% in in the SAPIEN 3 group among coronary arteries at CT-identified risk of sinus sequestration.
Conclusions
The risk of sinus sequestration in redo TAVR should be carefully screened by CT, especially in patients with low STJ height. TAV with low commissure height that was designed to achieve commissure-to-commissure alignment with the native aortic valves may be preferable to avoid the risk of coronary obstruction due to sinus sequestration and allow for a preventive leaflet laceration procedure in future redo TAVR. (Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Thrombosis and Its TrEatment With Anticoagulation [RESOLVE]; NCT02318342).

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

JACC Cardiovasc Interv: 22 Nov 2020; 13:2617-2627
Ochiai T, Oakley L, Sekhon N, Komatsu I, ... Cheng W, Makkar R
JACC Cardiovasc Interv: 22 Nov 2020; 13:2617-2627 | PMID: 33213747
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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: 08 Nov 2020; 13:2497-2507
Deseive S, Steffen J, Beckmann M, Jochheim D, ... Massberg S, Hausleiter J
JACC Cardiovasc Interv: 08 Nov 2020; 13:2497-2507 | PMID: 33069658
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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: 08 Nov 2020; 13:2510-2524
Shahanavaz S, Balzer D, Babaliaros V, Kim D, ... Gorelick J, Zahn EM
JACC Cardiovasc Interv: 08 Nov 2020; 13:2510-2524 | PMID: 33069657
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Impact:
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: 08 Nov 2020; 13:2542-2555
Barbanti M, Costa G, Picci A, Criscione E, ... Webb JG, Tamburino C
JACC Cardiovasc Interv: 08 Nov 2020; 13:2542-2555 | PMID: 33069648
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Abstract

Optimal Fluoroscopic Projections of Coronary Ostia and Bifurcations Defined by Computed Tomographic Coronary Angiography.

Kočka V, Thériault-Lauzier P, Xiong TY, Ben-Shoshan J, ... Leipsic J, Piazza N
Objectives
The aim of this study was to define the optimal fluoroscopic viewing angles of both coronary ostia and important coronary bifurcations by using 3-dimensional multislice computed tomographic data.
Background
Optimal fluoroscopic projections are crucial for coronary imaging and interventions. Historically, coronary fluoroscopic viewing angles were derived empirically from experienced operators.
Methods
In this analysis, 100 consecutive patients who underwent computed tomographic coronary angiography (CTCA) for suspected coronary artery disease were studied. A CTCA-based method is described to define optimal viewing angles of both coronary ostia and important coronary bifurcations to guide percutaneous coronary interventions.
Results
The average optimal viewing angle for ostial left main stenting was left anterior oblique (LAO) 37°, cranial (CRA) 22° (95% confidence interval [CI]: LAO 33° to 40°, CRA 19° to 25°) and for ostial right coronary stenting was LAO 79°, CRA 41° (95% CI: LAO 74° to 84°, CRA 37° to 45°). Estimated mean optimal viewing angles for bifurcation stenting were as follows: left main: LAO 0°, caudal (CAU) 49° (95% CI: right anterior oblique [RAO] 8° to LAO 8°, CAU 43° to 54°); left anterior descending with first diagonal branch: LAO 11°, CRA 71° (95% CI: RAO 6° to LAO 27°, CRA 66° to 77°); left circumflex bifurcation with first marginal branch: LAO 24°, CAU 33° (95% CI: LAO 15° to 33°, CAU 25° to 41°); and posterior descending artery and posterolateral branch: LAO 44°, CRA 34° (95% CI: LAO 35° to 52°, CRA 27° to 41°).
Conclusions
CTCA can suggest optimal fluoroscopic viewing angles of coronary artery ostia and bifurcations. As the frequency of use of diagnostic CTCA increases in the future, it has the potential to provide additional information for planning and guiding percutaneous coronary intervention procedures.

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

JACC Cardiovasc Interv: 08 Nov 2020; 13:2560-2570
Kočka V, Thériault-Lauzier P, Xiong TY, Ben-Shoshan J, ... Leipsic J, Piazza N
JACC Cardiovasc Interv: 08 Nov 2020; 13:2560-2570 | PMID: 33153569
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Abstract

Coronary Access After TAVR-in-TAVR as Evaluated by Multidetector Computed Tomography.

De Backer O, Landes U, Fuchs A, Yoon SH, ... Webb JG, Søndergaard L
Objectives
The aim of this study was to assess coronary accessibility after transcatheter aortic valve replacement (TAVR)-in-TAVR using multidetector computed tomography.
Background
Expanding TAVR to patients with longer life expectancy may involve more frequent bioprosthetic valve failure and need for redo TAVR. Coronary access after TAVR-in-TAVR may be challenging, particularly as the leaflets from the initial transcatheter heart valve (THV) will form a neo-skirt following TAVR-in-TAVR.
Methods
In 45 patients treated with different combinations of CoreValve and Evolut (CV/EV) THVs with supra-annular leaflet position and SAPIEN THVs with intra-annular leaflet position, post-TAVR-in-TAVR multidetector computed tomographic scans were analyzed to examine coronary accessibility.
Results
After TAVR-in-TAVR, the coronary arteries originated below the top of the neo-skirt in 90% of CV/EV-first cases compared with 67% of SAPIEN-first cases (p = 0.009). For these coronary arteries originating below the top of the neo-skirt, the distance between the THV and the aortic wall was <3 mm in 56% and 25% of CV/EV-first and SAPIEN-first cases, respectively (p = 0.035). Coronary access may be further complicated by THV-THV stent frame strut misalignment in 53% of CV/EV-in-CV/EV cases. The risk for technically impossible coronary access was 27% and 10% in CV/EV-first and SAPIEN-first cases, respectively (p = 0.121). Absence of THV interference with coronary accessibility can be expected in 8% and 33% of CV/EV-first and SAPIEN-first cases, respectively (p = 0.005).
Conclusions
Coronary access after TAVR-in-TAVR may be challenging in a significant proportion of patients. THVs with intra-annular leaflet position or low commissural height and large open cells may be preferable in terms of coronary access after TAVR-in-TAVR.

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

JACC Cardiovasc Interv: 08 Nov 2020; 13:2528-2538
De Backer O, Landes U, Fuchs A, Yoon SH, ... Webb JG, Søndergaard L
JACC Cardiovasc Interv: 08 Nov 2020; 13:2528-2538 | PMID: 33153567
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Impact:
Abstract

Early Multinational Experience of Transcatheter Tricuspid Valve Replacement for Treating Severe Tricuspid Regurgitation.

Hahn RT, Kodali S, Fam N, Bapat V, ... Tarantini G, Colli A
Objectives
The aim of this registry was to evaluate the feasibility and safety of transcatheter tricuspid valve implantation (TTVI) in patients with extreme surgical risk.
Background
Isolated tricuspid regurgitation (TR) surgery is associated with high in-hospital mortality.
Methods
Thirty consecutive patients (mean age 75 ± 10 years; 56% women) from 10 institutions, with symptomatic functional TR, had institutional and notified body approval for compassionate use of the GATE TTVI system. Baseline, discharge, and 30-day follow-up echocardiographic data and procedural, in-hospital, and follow-up clinical outcomes were collected.
Results
At baseline, all patients had multiple comorbidities, severe or greater TR, and reduced baseline right ventricular function. Technical success was achieved in 26 of 30 patients (87%). Device malpositioning occurred in 4 patients, with conversion to open heart surgery in 2 (5%). Of those who received the device, 100% had reductions in TR of ≥1, and 75% experienced reductions of ≥2 grades, resulting in 18 of 24 of patients (76%) with mild or less TR at discharge. All patients had mild or less central TR. There was continued improvement in TR grade between discharge and 30 days in 15 of 19 patients (79%). In-hospital mortality was 10%. At mean follow-up of 127 ± 82 days, 4 patients (13%) had died. Of patients alive at follow-up, 62% were in New York Heart Association functional class I or II, with no late device-related adverse events.
Conclusions
Compassionate treatment of severe, symptomatic functional TR using a first-generation TTVI device is associated with significant reduction in TR and improvement in functional status with acceptable in-hospital mortality. Further studies are needed to determine the appropriate patient population and long-term outcomes with TTVI therapy.

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

JACC Cardiovasc Interv: 08 Nov 2020; 13:2482-2493
Hahn RT, Kodali S, Fam N, Bapat V, ... Tarantini G, Colli A
JACC Cardiovasc Interv: 08 Nov 2020; 13:2482-2493 | PMID: 33153565
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Abstract

Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System.

Fontana GP, Bedogni F, Groh M, Smith D, ... Jilaihawi H, Makkar RR
Objectives
The aim of this study was to characterize the safety profile of an intra-annular self-expanding valve with a next-generation low-profile delivery system (DS).
Background
Key design modifications to the FlexNav DS include the addition of a hydrophilic-coated, integrated sheath and stability layer to facilitate gradual, controlled deployment in vessels with diameter ≥5 mm.
Methods
Patients were pooled from 2 concurrent prospective, multicenter, single-arm studies (FlexNav DS arm of PORTICO IDE [Portico Re-Sheathable Transcatheter Aortic Valve System U.S. IDE Trial] [n = 134] and the FlexNav EU CE Mark Study [n = 46]) for the analysis. The primary endpoint was Valve Academic Research Consortium-2-defined major vascular complications at 30 days. Clinical outcomes and valve performance were assessed through 30 days by an independent clinical events committee and an echocardiography core laboratory, respectively.
Results
One hundred forty high-risk and 40 extreme-risk subjects enrolled between October 15, 2018, and December 10, 2019, from 28 sites in the United States, Australia, and Europe who underwent attempted transfemoral Portico valve implantation were included. The mean age was 85.1 ± 5.6 years, 60% were women, the mean Society of Thoracic Surgeons score was 5.3%, and 96.1% presented with ≥1 frailty factor. Technical device success was 96.7%. At 30 days, the rate of major vascular complications was 5.0%, with 4.4% of complications adjudicated as access site-related (3.3% transcatheter aortic valve replacement DS access site-related). Death (0.6%) and disabling stroke (1.1%) were rare. The rate of new permanent pacemaker implantation was 15.4%. Echocardiography revealed a mean gradient of 7.1 ± 3.2 mm Hg, mean valve area of 1.77 ± 0.41 cm, and a 4.1% rate of moderate paravalvular leak at 30 days.
Conclusions
Portico valve implantation with the FlexNav DS was associated with an excellent safety profile at 30 days.

Copyright © 2020. Published by Elsevier Inc.

JACC Cardiovasc Interv: 08 Nov 2020; 13:2467-2478
Fontana GP, Bedogni F, Groh M, Smith D, ... Jilaihawi H, Makkar RR
JACC Cardiovasc Interv: 08 Nov 2020; 13:2467-2478 | PMID: 33153563
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Abstract

Delirium After TAVR: Crosspassing the Limit of Resilience.

van der Wulp K, van Wely MH, Rooijakkers MJP, Brouwer MA, ... Morshuis WJ, van Royen N

Patients who undergo transcatheter aortic valve replacement often are frail and elderly. Delirium is a frequently observed complication, associated with impaired recovery, prolonged hospital stay, and mortality. In different hospital settings, interventions that reduced the incidence of delirium resulted in improved clinical outcome and reduced costs. In that context, prevention, early recognition, and timely interventions could be the next step toward better outcomes of transcatheter aortic valve replacement. This review is focused on awareness and recognition of delirium, including predisposing \"vulnerability\" factors (such as cognitive impairment and carotid artery disease) and \"trigger\" factors (such as anesthesia, hemodynamic imbalance, and complications). For prevention and treatment, clinicians should focus on sleep hygiene, orientation, pain management, and early mobilization. In case of delirium, a thorough search and treatment of trigger factors is warranted. Future studies should focus on risk assessment, preventive and therapeutic interventions, and their potential benefit in terms of costs and clinical outcomes.

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

JACC Cardiovasc Interv: 08 Nov 2020; 13:2453-2466
van der Wulp K, van Wely MH, Rooijakkers MJP, Brouwer MA, ... Morshuis WJ, van Royen N
JACC Cardiovasc Interv: 08 Nov 2020; 13:2453-2466 | PMID: 33153562
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Abstract

Elective Percutaneous Coronary Intervention in Ambulatory Surgery Centers.

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

Published by Elsevier Inc.

JACC Cardiovasc Interv: 03 Nov 2020; epub ahead of print
Li K, Kalwani NM, Heidenreich PA, Fearon WF
JACC Cardiovasc Interv: 03 Nov 2020; epub ahead of print | PMID: 33183992
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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: 25 Oct 2020; 13:2361-2370
Lisko JC, Greenbaum AB, Guyton RA, Kamioka N, ... Lederman RJ, Babaliaros VC
JACC Cardiovasc Interv: 25 Oct 2020; 13:2361-2370 | PMID: 33011144
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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: 25 Oct 2020; 13:2388-2398
Tiwana J, Aldea G, Levin DB, Johnson K, ... Reisman M, McCabe JM
JACC Cardiovasc Interv: 25 Oct 2020; 13:2388-2398 | PMID: 33011142
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Impact:
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: 25 Oct 2020; 13:2402-2414
Chakravarty T, Makar M, Patel D, Oakley L, ... Nakamura M, Makkar RR
JACC Cardiovasc Interv: 25 Oct 2020; 13:2402-2414 | PMID: 33011141
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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: 25 Oct 2020; 13:2427-2437
Alperi A, Dagenais F, Del Val D, Bernier M, ... Granada JF, Rodés-Cabau J
JACC Cardiovasc Interv: 25 Oct 2020; 13:2427-2437 | PMID: 33069643
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Impact:
Abstract

Transcatheter Mitral Valve Replacement With the Transseptal EVOQUE System.

Webb J, Hensey M, Fam N, Rodés-Cabau J, ... Guyton R, Herrmann H
Objectives
The aim of this study was to examine the initial experience with a novel transseptal transcatheter mitral valve replacement (TMVR) system.
Background
Transseptal TMVR may offer a less invasive option than surgery for mitral regurgitation (MR) with greater efficacy and fewer anatomic limitations than transcatheter repair.
Methods
Patients were treated with the EVOQUE TMVR system from September 2018 to October 2019. Key inclusion criteria were moderate or greater MR, New York Heart Association functional class ≥II, and high or prohibitive surgical risk. The primary outcome was technical success, defined by Mitral Valve Academic Research Consortium criteria.
Results
Fourteen patients were treated, all with at least moderate to severe MR. The median age was 84 years, and the median Society of Thoracic Surgeons score was 4.6%. MR was degenerative in 4 (28.6%), functional in 3 (21.4%), and mixed in 7 (50%). Technical success was achieved in 13 patients (92.9%), and 1 patient was converted to surgery. At 30 days there was 1 noncardiovascular mortality (7.1%), 2 strokes (14.3%), no myocardial infarctions, and no rehospitalizations. Two patients (14.3%) underwent paravalvular leak closure. One patient (7.1%) underwent alcohol septal ablation for left ventricular outflow tract obstruction. Including the 2 patients with paravalvular leak closure, MR was mild or less in all implanted patients at 30 days, with no MR in 10 (83.3%). Mean mitral gradient was 5.8 mm Hg (median). New York Heart Association functional class improved to ≤II in 9 patients (81.8%).
Conclusions
This first-in-human experience has demonstrated the feasibility of the transseptal EVOQUE TMVR system. Further clinical studies are required to establish safety and clinical outcomes.

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

JACC Cardiovasc Interv: 25 Oct 2020; 13:2418-2426
Webb J, Hensey M, Fam N, Rodés-Cabau J, ... Guyton R, Herrmann H
JACC Cardiovasc Interv: 25 Oct 2020; 13:2418-2426 | PMID: 33092713
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Impact:
Abstract

Atrial Fibrillation and Transcatheter Repair of Functional Mitral Regurgitation: Evidence From a Meta-Regression.

Kaur S, Sadana D, Patel J, Gad M, ... Harb SC, Kapadia SR
Objectives
The aim of this study was to assess the impact of atrial fibrillation (AF) on mortality and efficacy in patients with functional mitral regurgitation (FMR) undergoing MitraClip implantation.
Background
AF is a common arrhythmia in patients with severe FMR undergoing transcatheter mitral valve repair with the MitraClip device. Although AF has been consistently shown to be associated with poor outcomes after mitral valve surgery, the impact of AF on outcomes of MitraClip placement in patients with FMR has not been well studied.
Methods
Prospective, retrospective registries, observational studies, and randomized controlled trials on MitraClip reporting AF and FMR as one of the variables from inception until January 2019 were included.
Results
Of the initial 1,694 studies, 15 studies met the inclusion criteria. From a total of 5,184 patients, 2,105 patients were identified to have FMR and AF. All-cause 30-day mortality in patients with FMR was 3.7% (95% confidence interval: 2.87 to 4.66) and 1-year mortality was 17.9% (95% confidence interval: 16.01 to 19.71). The meta-regression analysis studying the impact of AF among patients with FMR treated with the MitraClip demonstrated no difference in mortality at 30 days but demonstrated significantly increased mortality at 1 year (95% confidence interval: 0.0006 to 0.0027) (p = 0.004). AF did not influence procedural success.
Conclusions
This meta-regression identifies AF as an independent negative predictor of long-term mortality after MitraClip implantation in patients with FMR. The mechanism of worse outcomes in patients with AF requires further study.

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

JACC Cardiovasc Interv: 25 Oct 2020; 13:2374-2384
Kaur S, Sadana D, Patel J, Gad M, ... Harb SC, Kapadia SR
JACC Cardiovasc Interv: 25 Oct 2020; 13:2374-2384 | PMID: 33092711
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Impact:
Abstract

1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study.

Webb JG, Hensey M, Szerlip M, Schäfer U, ... Feldman TE, Lim DS
Objectives
The authors report the CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) expanded experience, 1-year outcomes, and analysis by functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR).
Background
The 30-day results from the CLASP study of the PASCAL transcatheter valve repair system for clinically significant mitral regurgitation (MR) have been previously reported.
Methods
Eligible patients had symptomatic MR ≥3+, were receiving optimal medical therapy, and were deemed candidates for transcatheter mitral repair by the local heart team. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30 days. Follow-up was continued to 1 year.
Results
One hundred nine patients were treated (67% FMR, 33% DMR); the mean age was 75.5 years, and 57% were in New York Heart Association functional class III or IV. At 30 days, there was 1 cardiovascular death (0.9%), MR ≤1+ was achieved in 80% of patients (77% FMR, 86% DMR) and MR ≤2+ in 96% (96% FMR, 97% DMR), 88% of patients were in New York Heart Association functional class I or II, 6-min walk distance had improved by 28 m, and Kansas City Cardiomyopathy Questionnaire score had improved by 16 points (p < 0.001 for all). At 1 year, Kaplan-Meier survival was 92% (89% FMR 96% DMR) with 88% freedom from heart failure hospitalization (80% FMR, 100% DMR), MR was ≤1+ in 82% of patients (79% FMR, 86% DMR) and ≤2+ in 100% of patients, 88% of patients were in New York Heart Association functional class I or II, and Kansas City Cardiomyopathy Questionnaire score had improved by 14 points (p < 0.001 for all).
Conclusions
The PASCAL transcatheter valve repair system demonstrated a low complication rate and high survival, with robust sustained MR reduction accompanied by significant improvements in functional status and quality of life at 1 year. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study [CLASP]; NCT03170349).

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

JACC Cardiovasc Interv: 25 Oct 2020; 13:2344-2357
Webb JG, Hensey M, Szerlip M, Schäfer U, ... Feldman TE, Lim DS
JACC Cardiovasc Interv: 25 Oct 2020; 13:2344-2357 | PMID: 33092709
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Abstract

Baseline Functional Capacity and Transcatheter Mitral Valve Repair in Heart Failure With Secondary Mitral Regurgitation.

Malik UI, Ambrosy AP, Ku IA, Mishell JM, ... Mack MJ, Stone GW
Objectives
The aim of this study was to determine the prognostic utility of baseline functional status and its impact on the outcomes of transcatheter mitral valve repair (TMVr) in patients with heart failure (HF) with secondary mitral regurgitation (SMR).
Background
The COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial demonstrated that TMVr with the MitraClip in patients with HF with moderate to severe or severe SMR improved health-related quality of life. The clinical utility of a baseline assessment of functional status for evaluating prognosis and identifying candidates likely to derive a robust benefit from TMVr has not been previously studied in patients with HF with SMR.
Methods
The COAPT study was a multicenter, randomized, controlled, parallel-group, open-label trial of TMVr with the MitraClip plus guideline-directed medical therapy (GDMT) versus GDMT alone in patients with HF, left ventricular ejection fraction 20% to 50%, and moderate to severe or severe SMR. Baseline functional status was assessed by 6-min walk distance (6MWD).
Results
Patients with 6MWD less than the median (240 m) were older, were more likely to be female, and had more comorbidities. After multivariate modeling, age (p = 0.005), baseline hemoglobin (p = 0.007), and New York Heart Association functional class III/IV symptoms (p < 0.0001) were independent clinical predictors of 6MWD. Patients with 6MWD <240 m versus ≥240 m had a higher unadjusted and adjusted rate of the 2-year composite of all-cause death or HF hospitalization (64.4% vs. 48.6%; adjusted hazard ratio: 1.53; 95% confidence interval: 1.19 to 1.98; p = 0.001). However, there was no interaction between baseline 6MWD and the relative effectiveness of TMVr plus GDMT versus GDMT alone with respect to the composite endpoint (p = 0.633).
Conclusions
Baseline assessment of functional capacity by 6MWD was a powerful discriminator of prognosis in patients with HF with SMR. TMVr with the MitraClip provided substantial improvements in clinical outcomes for this population irrespective of baseline functional capacity.

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

JACC Cardiovasc Interv: 25 Oct 2020; 13:2331-2341
Malik UI, Ambrosy AP, Ku IA, Mishell JM, ... Mack MJ, Stone GW
JACC Cardiovasc Interv: 25 Oct 2020; 13:2331-2341 | PMID: 33092707
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Abstract

NYHA Functional Classification and Outcomes After Transcatheter Mitral Valve Repair in Heart Failure: The COAPT Trial.

Giustino G, Lindenfeld J, Abraham WT, Kar S, ... Mack MJ, Stone GW
Objectives
The aim of this study was to evaluate the outcomes of MitraClip implantation versus guideline-directed medical therapy (GDMT) in patients with secondary mitral regurgitation (SMR) according to baseline functional status as assessed by the widely used New York Heart Association (NYHA) functional classification.
Background
Patients with heart failure (HF) and impaired functional status at baseline have poor prognosis. Whether the effects of transcatheter repair of secondary SMR in patients with HF are influenced by baseline functional status is unknown.
Methods
In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, patients with HF with moderate to severe or severe SMR who remained symptomatic despite maximally tolerated GDMT were randomized to MitraClip implantation versus GDMT alone. Outcomes were evaluated according to baseline functional status as assessed using the NYHA functional classification. The primary endpoint of interest was the rate of death or HF-related hospitalization (HFH) at 2 years in time-to-first-event analyses.
Results
Among 613 randomized patients, 240 were in NYHA functional class II (39.2%), 322 were in NYHA functional class III (52.5%), and 51 were in ambulatory NYHA functional class IV (8.3%). Rates of death or HFH were progressively higher with increasing NYHA functional class. Compared with GDMT alone, MitraClip implantation resulted in lower 2-year rates of death or HFH consistently in patients in NYHA functional class II (39.7% vs. 63.7%; hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.37 to 0.77), NYHA functional class III (46.6% vs. 65.5%; HR: 0.60; 95% CI: 0.45 to 0.82), and NYHA functional class IV (66.7% vs. 85.2%; HR: 0.55; 95% CI: 0.28 to 1.10; p = 0.86). Greater improvements in quality of life at 2 years were observed in patients treated with the MitraClip compared with GDMT irrespective of baseline functional status.
Conclusions
The NYHA functional classification provides prognostic utility in patients with HF and moderate to severe or severe SMR. In the COAPT trial, the benefits of MitraClip implantation were consistent in patients with better or worse functional status as assessed by NYHA functional class. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079).

Copyright © 2020. Published by Elsevier Inc.

JACC Cardiovasc Interv: 25 Oct 2020; 13:2317-2328
Giustino G, Lindenfeld J, Abraham WT, Kar S, ... Mack MJ, Stone GW
JACC Cardiovasc Interv: 25 Oct 2020; 13:2317-2328 | PMID: 33092705
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Impact:

This program is still in alpha version.