Journal: JACC Cardiovasc Interv

Sorted by: date / impact
Abstract

Transcatheter Aortic Valve Replacement in Failed Transcatheter Bioprosthetic Valves.

Tarantini G, Sathananthan J, Fabris T, Landes U, ... Søndergaard L, Tang GHL
Transcatheter aortic valve replacement (TAVR) is increasingly being performed in younger and lower surgical risk patients. Given the longer life expectancy of these patients, the bioprosthetic valve will eventually fail, and aortic valve reintervention may be necessary. Although currently rare, redo-TAVR will likely increase in the future as younger patients are expected to outlive their transcatheter bioprosthesis. This review provides a contemporary overview of the indications, procedural planning, implantation technique, and outcomes of TAVR in failed transcatheter bioprosthetic aortic valves.

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

JACC Cardiovasc Interv: 26 Sep 2022; 15:1777-1793
Tarantini G, Sathananthan J, Fabris T, Landes U, ... Søndergaard L, Tang GHL
JACC Cardiovasc Interv: 26 Sep 2022; 15:1777-1793 | PMID: 36137681
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Apixaban and Valve Thrombosis After Transcatheter Aortic Valve Replacement: The ATLANTIS-4D-CT Randomized Clinical Trial Substudy.

Montalescot G, Redheuil A, Vincent F, Desch S, ... Collet JP, ATLANTIS Investigators of the ACTION Group
Background
Subclinical obstructive valve thrombosis after transcatheter aortic valve replacement (TAVR) is of uncertain frequency and clinical impact.
Objectives
The aim of this study was to determine the effects of apixaban vs standard of care on post-TAVR valve thrombosis detected by 4-dimensional (4D) computed tomography.
Methods
The randomized ATLANTIS (Anti-Thrombotic Strategy to Lower All Cardiovascular and Neurologic Ischemic and Hemorrhagic Events After Trans-Aortic Valve Implantation for Aortic Stenosis) trial demonstrated that apixaban 5 mg twice daily was not superior to standard of care (vitamin K antagonists or antiplatelet therapy) after successful TAVR and was associated with similar safety but with more noncardiovascular deaths. Three months after randomization, 4D computed tomography was proposed to all patients to determine the percentage of patients with ≥1 prosthetic valve leaflet with grade 3 or 4 reduced leaflet motion or grade 3 or 4 hypoattenuated leaflet thickening (the primary endpoint) in the intention-to-treat population.
Results
Seven hundred sixty-two participants had complete multiphase datasets and were included in the 4D computed tomographic analysis. The primary endpoint occurred in 33 (8.9%) and 51 (13.0%) patients in the apixaban and standard-of-care groups, respectively. It was reduced with apixaban vs antiplatelet therapy (OR: 0.51; 95% CI: 0.30-0.86) but not vs vitamin K antagonists (OR: 1.80; 95% CI: 0.62-5.25) (Pinteraction = 0.037). The composite of death, myocardial infarction, any stroke, or systemic embolism at 1 year occurred in 10.7% (n = 9 of 84) and 7.1% (n = 48 of 178) of patients with and without subclinical valve thrombosis at 90 days, respectively (HR: 1.68; 95% CI: 0.82-3.44).
Conclusions
Apixaban reduced subclinical obstructive valve thrombosis in the majority of patients who underwent TAVR without having an established indication for anticoagulation. This study was not powered for clinical outcomes. (Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis [ATLANTIS]; NCT02664649).

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

JACC Cardiovasc Interv: 26 Sep 2022; 15:1794-1804
Montalescot G, Redheuil A, Vincent F, Desch S, ... Collet JP, ATLANTIS Investigators of the ACTION Group
JACC Cardiovasc Interv: 26 Sep 2022; 15:1794-1804 | PMID: 36137682
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Management and Outcome of Acute Ischemic Stroke Complicating Transcatheter Aortic Valve Replacement.

Levi A, Linder M, Seiffert M, Witberg G, ... Kornowski R, ASTRO-TAVI Study Group
Background
Despite advances in transcatheter aortic valve replacement (TAVR), periprocedural acute ischemic stroke remains a concern.
Objectives
The aims of this study were to investigate acute ischemic stroke complicating TAVR (AISCT) and to describe the indications and outcomes of interventions to treat AISCT.
Methods
An international multicenter registry was established focusing on AISCT within 30 days of TAVR. Stroke severity was assessed using the National Institutes of Health Stroke Scale. Primary outcomes were 1-year all-cause death and neurologic disability status at 90 days according to modified Rankin scale score.
Results
Of 16,615 TAVR procedures, 387 patients with AISCT were included (2.3%). Rates of 1-year death were 28.9%, 35.9%, and 77.5% in patients with mild, moderate, and severe stroke, respectively (P < 0.001). Although 348 patients were managed conservatively, 39 patients (10.1%) underwent neurointervention (NI) with either mechanical thrombectomy (n = 26) or thrombolytic therapy (n = 13). In a subanalysis excluding patients with mild stroke, there was no clear 1-year survival benefit for NI compared with conservative management (47.6% vs 41.1%, respectively; P = 0.78). In a logistic regression model controlling for stroke severity, NI was associated with 2.9-fold odds (95% CI: 1.2-7.0; P = 0.016) of independent survival at 90 days.
Conclusions
AISCT carries significant morbidity and mortality, which is correlated with stroke severity. The present findings suggest that neurologic disability for patients with moderate or worse stroke could potentially be improved by timely intervention and highlight the importance of collaboration between cardiologists and neurologists to optimize AISCT outcomes.

Copyright © 2022. Published by Elsevier Inc.

JACC Cardiovasc Interv: 26 Sep 2022; 15:1808-1819
Levi A, Linder M, Seiffert M, Witberg G, ... Kornowski R, ASTRO-TAVI Study Group
JACC Cardiovasc Interv: 26 Sep 2022; 15:1808-1819 | PMID: 36137683
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Impact of Right Ventricle-Pulmonary Artery Coupling on Clinical Outcomes in the PARTNER 3 Trial.

Cahill TJ, Pibarot P, Yu X, Babaliaros V, ... Leon MB, Hahn RT
Background
Physiologic right ventricle-pulmonary artery (RV-PA) coupling may be impaired in patients with aortic stenosis (AS).
Objectives
This study aimed to assess the incidence and prognostic significance of impaired RV-PA coupling in low-risk patients with symptomatic severe AS undergoing transcatheter aortic valve replacement or surgical aortic valve replacement.
Methods
RV-PA coupling was measured by transthoracic echocardiography as the ratio of tricuspid annular plane systolic excursion (TAPSE) to pulmonary artery systolic pressure (PASP) in patients in the PARTNER (Placement of Aortic Transcatheter Valve) 3 trial. The primary endpoint was the composite of all-cause mortality, stroke, and rehospitalization at the 2-year follow-up.
Results
Among 570 low-risk patients included in the analysis, RV-PA uncoupling was defined by a TAPSE/PASP ratio ≤ 0.55 mm/mm Hg. At baseline, 222 of 570 (38.9%) patients had RV-PA uncoupling. At 2 years, patients with baseline RV-PA uncoupling had an increased incidence of the primary endpoint (19.1% vs 9.9%, P = 0.002), all-cause mortality (5.9% vs 0.6%, P < 0.001), cardiovascular mortality (4.1% vs 0.6%, P = 0.003), and rehospitalization (13.5% vs 7.3%, P = 0.018). On multivariable analysis, baseline RV-PA uncoupling remained an independent predictor of the primary endpoint at 2 years (HR: 1.92; 95% CI: 1.04-3.57; P = 0.038).
Conclusions
In patients with symptomatic severe AS at low surgical risk undergoing transcatheter aortic valve replacement or surgical aortic valve replacement, baseline RV-PA uncoupling defined by TAPSE/PASP ≤ 0.55 mm Hg was associated with adverse clinical outcomes at 2 years, including all-cause mortality, cardiovascular mortality, and rehospitalization.

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

JACC Cardiovasc Interv: 26 Sep 2022; 15:1823-1833
Cahill TJ, Pibarot P, Yu X, Babaliaros V, ... Leon MB, Hahn RT
JACC Cardiovasc Interv: 26 Sep 2022; 15:1823-1833 | PMID: 36137685
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Transvalvular Pressure Gradients and All-Cause Mortality Following TAVR: A Multicenter Echocardiographic and Invasive Registry.

Khalili H, Pibarot P, Hahn RT, Elmariah S, ... Rodès-Cabau J, Abbas AE
Background
Low ejection fraction (EF) and low flow as determined by an echocardiographic stroke volume index (SVi) <35 mL/m2 are associated with low transvalvular gradients and increased mortality in both severe aortic stenosis (AS) and post-transcatheter aortic valve replacement (TAVR). Absence of an elevated echocardiographic transaortic gradient post-TAVR is considered a marker of procedural success despite the absence of data on its impact on mortality.
Objectives
The authors sought to examine the association of invasive and echocardiographic gradients post-TAVR with all-cause mortality in relation to flow and EF.
Methods
In a multicenter retrospective registry of patients undergoing TAVR, Cox models with regression splines explored the relationship between invasive and echocardiographic gradients post-TAVR with 2-year mortality. An invasive gradient <5 mm Hg was considered low, between ≥5 and <10 mm Hg was considered intermediate, and ≥10 mm Hg was considered high. An echocardiographic gradient <10 mm Hg was considered low, ≥10 and <20 mm Hg was considered intermediate, and ≥20 mm Hg was considered high.
Results
Higher mortality occurred in low echocardiographic gradients at discharge relative to intermediate gradients (P < 0.001), and low gradient was associated with lower EF and echocardiographic SVi (P < 0.001 and P < 0.008, respectively). Lower mortality occurred in low invasive gradients relative to intermediate gradients (P = 0.012) with no difference in EF and echocardiographic SVi between groups (P = 0.089 and P = 0.947, respectively). There were insufficient observations to determine the impact of high echocardiographic and invasive gradients on mortality.
Conclusions
In this large retrospective analysis, the impact of transaortic gradients on mortality after TAVR was not linear and complex, showing opposite results among echocardiographic and invasive measurements in low-gradient patients.

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

JACC Cardiovasc Interv: 26 Sep 2022; 15:1837-1848
Khalili H, Pibarot P, Hahn RT, Elmariah S, ... Rodès-Cabau J, Abbas AE
JACC Cardiovasc Interv: 26 Sep 2022; 15:1837-1848 | PMID: 36137687
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents: BIOFLOW V Final 5-Year Outcomes.

Kandzari DE, Koolen JJ, Doros G, Garcia-Garcia HM, ... Waksman R, BIOFLOW V Investigators
Background
Randomized trials have demonstrated the superiority of ultrathin strut drug-eluting stents compared with alternative stent designs. Whether these differences persist over late-term follow-up is uncertain.
Objectives
This study sought to compare late-term (5-year) clinical outcomes among patients treated with ultrathin strut (60 µm) bioresorbable polymer sirolimus-eluting stents (BP SES) and thin strut (81 µm) durable polymer everolimus-eluting stents (DP EES).
Methods
BIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects with Up to Three De Novo or Restenotic Coronary Artery Lesions V) was an international, 2:1 randomized trial comparing percutaneous coronary intervention with ultrathin strut BP SES versus thin strut DP EES regarding the primary endpoint of 12-month target lesion failure (TLF). Prespecified outcomes through 5 years were assessed.
Results
Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 5-year rates of TLF were 12.3% for BP SES and 15.3% for DP EES (P = 0.108). Revascularization with BP SES was associated with a significantly lower target vessel-related myocardial infarction (6.6% vs 10.3%, P = 0.015) and late/very late definite/probable stent thrombosis (0.3% vs 1.6%, P = 0.021). Ischemia-driven target lesion revascularization was numerically but not significantly lower with BP SES (5.9% vs 7.7%, P = 0.202). Cardiac death rates were 2.6% versus 1.9% (P = 0.495) for BP SES and DP EES, respectively.
Conclusions
In a large, randomized trial, TLF and the individual outcomes of cardiac death and target lesion revascularization at 5 years were similar among patients treated with BP SES versus DP EES. Both target vessel-related myocardial infarction and late/very late definite/probable stent thrombosis were significantly lower with BP SES. These results confirm the durability of safety and the effectiveness of percutaneous coronary intervention with ultrathin BP SES.

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

JACC Cardiovasc Interv: 26 Sep 2022; 15:1852-1860
Kandzari DE, Koolen JJ, Doros G, Garcia-Garcia HM, ... Waksman R, BIOFLOW V Investigators
JACC Cardiovasc Interv: 26 Sep 2022; 15:1852-1860 | PMID: 36137689
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Rotational Atherectomy or Balloon-Based Techniques to Prepare Severely Calcified Coronary Lesions.

Rheude T, Fitzgerald S, Allali A, Mashayekhi K, ... Cassese S, Abdel-Wahab M
Background
The comparative efficacy of percutaneous techniques for the preparation of calcified lesions before stenting remains poorly studied.
Objectives
This study sought to compare the performance of up-front rotational atherectomy (RA) or balloon-based techniques before drug-eluting stent implantation in severely calcified coronary lesions as assessed by angiography and optical coherence tomography (OCT).
Methods
Patient-level data from the PREPARE-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) and ISAR-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) randomized trials were pooled. The primary endpoint was stent expansion as assessed by OCT imaging. The secondary endpoints included stent eccentricity, stent asymmetry, angiographic acute lumen gain, strategy success and in-hospital occurrence of cardiac death, target vessel myocardial infarction, and repeat revascularization.
Results
Among 274 patients originally randomized, 200 participants with available OCT data after lesion preparation with RA (n = 63), a modified balloon (MB, n = 103), or a super high-pressure balloon (n = 34) before stenting were analyzed. The use of RA versus MB or a super high-pressure balloon led to comparable stent expansion (73.2% ± 11.6% vs 70.8% ± 13.6% vs 71.8% ± 12.2%, P = 0.49) and stent asymmetry (P = 0.83). Compared with RA or MB, a super high-pressure balloon was associated with less stent eccentricity (P = 0.03) with a numerically higher acute lumen gain, albeit not significantly different (P = 0.08). Strategy success was more frequent with RA versus MB (P = 0.002) and numerically more frequent with RA versus a super high-pressure balloon (P = 0.06). Clinical outcomes did not differ between groups.
Conclusions
In patients with severely calcified lesions undergoing drug-eluting stent implantation, lesion preparation with RA, MB, or a super high-pressure balloon was associated with comparable stent expansion. A super high-pressure balloon is associated with less stent eccentricity, whereas strategy success is more frequent with RA.

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

JACC Cardiovasc Interv: 26 Sep 2022; 15:1864-1874
Rheude T, Fitzgerald S, Allali A, Mashayekhi K, ... Cassese S, Abdel-Wahab M
JACC Cardiovasc Interv: 26 Sep 2022; 15:1864-1874 | PMID: 36137691
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Optical Coherence Tomography Fractional Flow Reserve and Cardiovascular Outcomes in Patients With Acute Coronary Syndrome.

Kakizaki S, Otake H, Seike F, Kawamori H, ... Yamaguchi O, Hirata KI
Background
Optical coherence tomography-derived fractional flow reserve (OCT-FFR) correlates strongly with wire-based FFR; however, its clinical significance remains uncertain.
Objectives
The study sought to investigate the relationship between post-percutaneous coronary intervention (PCI) OCT-FFR and long-term clinical outcomes in acute coronary syndrome (ACS).
Methods
This retrospective, multicenter, observational cohort study included consecutive patients with ACS who underwent OCT-guided emergency PCI. We analyzed post-PCI OCT images and calculated OCT-FFR to identify independent factors associated with target vessel failure (TVF) after PCI.
Results
Among 364 enrolled patients, 54 experienced TVF during a median follow-up of 36 (IQR: 26-48) months. Vessel-level OCT-FFR was significantly lower in the TVF group than in the non-TVF group (0.87 vs 0.94; P < 0.001). In the multivariable Cox regression analysis, low vessel-level OCT-FFR (HR per 0.1 increase: 0.38; 95% CI: 0.29-0.49; P < 0.001) and thin-cap fibroatheroma in the nonculprit lesion were independently associated with TVF. The TVF rate of vessels with both low vessel-level OCT-FFR (<0.90) and thin-cap fibroatheroma in the nonculprit lesion was 8.1 times higher than that of all other vessels (69.3% vs 12.4%; HR: 8.13; 95% CI: 4.33-15.25; log-rank P < 0.001). Furthermore, adding vessel-level OCT-FFR to baseline characteristics and post-PCI OCT findings improved discriminatory and reclassification ability in identifying patients with subsequent TVF.
Conclusions
Vessel-level OCT-FFR was an independent factor associated with TVF after PCI in patients with ACS. Adding the OCT-FFR measurement to post-PCI OCT findings may enable better discrimination of patients with subsequent TVF after PCI for ACS. (Relationship between Intracoronary Optical Coherence Tomography Derived Virtual Fractional Flow Reserve and cardiovascular outcome on Acute coronary syndrome; UMIN000043858).

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

JACC Cardiovasc Interv: 21 Sep 2022; epub ahead of print
Kakizaki S, Otake H, Seike F, Kawamori H, ... Yamaguchi O, Hirata KI
JACC Cardiovasc Interv: 21 Sep 2022; epub ahead of print | PMID: 36182656
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Hemodynamic Profiles and Clinical Response to Transcatheter Mitral Repair.

Sato H, Cavalcante JL, Bae R, Enriquez-Sarano M, ... Fukui M, Sorajja P
Background
Prediction of the clinical response to transcatheter edge-to-edge repair (TEER) remains a vexing challenge.
Objectives
This study sought to examine the relation between hemodynamic profiles and outcomes following mitral TEER.
Methods
Among 378 patients (median age 82 years; 43.9% women), 3 hemodynamic profiles using residual left atrial pressure (LAP) and mitral regurgitation (MR) were defined: type I (optimal), grade ≤1 MR and mean LAP (mLAP) ≤15 mm Hg; type II (mixed), MR grade >1 or mLAP >15 mm Hg; and type III (poor), MR grade >1 and mLAP >15 mm Hg. The discrimination of these profiles for predicting outcomes was examined. A positive clinical response to TEER was defined as improvement in New York Heart Association functional class ≥I grade at 1 year without heart failure rehospitalization or death.
Results
There were 148 (39.0%) patients classified as optimal (type I), 187 (49.0%) patients as mixed (type II), and 43 (11.0%) patients as poor (type III). For all-cause mortality, survival at 1 year was 91.6%, 82.6%, and 67.9% for types I, II, and III, respectively (HR: 2.13; 95% CI: 1.44-3.15; P < 0.001). For the composite endpoint of all-cause mortality and rehospitalization for heart failure, event-free survival at 1 year was 84.1%, 70.7%, and 53.2% for types I, II, and III, respectively (HR: 1.93; 95% CI: 1.41-2.65; P < 0.001). Hemodynamic profiling was strongly associated with a positive response to TEER, occurring in 73.9%, 57.0%, 35.0%, for types I, II, and III, respectively (P < 0.001).
Conclusions
In patients undergoing mitral TEER, hemodynamic profiling is prognostic, with superior survival occurring among patients with optimal reduction in MR and normal postprocedural LAP.

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

JACC Cardiovasc Interv: 12 Sep 2022; 15:1697-1707
Sato H, Cavalcante JL, Bae R, Enriquez-Sarano M, ... Fukui M, Sorajja P
JACC Cardiovasc Interv: 12 Sep 2022; 15:1697-1707 | PMID: 36075641
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Outcomes After Transcatheter Edge-to-Edge Mitral Valve Repair According to Mitral Regurgitation Etiology and Cardiac Remodeling.

Yoon SH, Makar M, Kar S, Chakravarty T, ... Bax JJ, Makkar RR
Background
Transcatheter edge-to-edge repair (TEER) has been increasingly used for selected patients with mitral regurgitation (MR), but limited data are available regarding clinical outcomes in patients with varied etiology and mechanism of MR.
Objectives
The aim of this study was to evaluate the outcomes of TEER according to etiology and left ventricular (LV) and left atrial remodeling.
Methods
Consecutive patients who underwent TEER between 2007 and 2020 were included in the analysis. Among patients with functional MR (FMR), those with predominant LV remodeling were classified as having ventricular FMR (v-FMR), whereas those without LV remodeling but predominant left atrial remodeling were classified as having atrial FMR (a-FMR). The primary outcome was a composite of all-cause mortality and heart failure hospitalization at 2 years and was compared among patients with degenerative MR (DMR), a-FMR, and v-FMR.
Results
A total of 1,044 patients (11% with a-FMR, 48% with v-FMR, and 41% with DMR) with a mean Society of Thoracic Surgeons score of 8.6 ± 7.8 underwent TEER. Patients with a-FMR had higher rates of atrial fibrillation and severe tricuspid regurgitation with larger left and right atria, whereas patients with v-FMR had lower LV ejection fractions with larger LV dimensions. Residual MR more than moderate at discharge was not significantly different among the 3 groups (5.2% vs 3.2% vs 2.6%; P = 0.37). Compared with patients with DMR, 2-year event rates of the primary outcome were significantly higher in patients with a-FMR and v-FMR (21.6% vs 31.5% vs 42.3%; log-rank P < 0.001).
Conclusions
Despite excellent procedural outcomes, patients with a-FMR and v-FMR had worse clinical outcomes compared with those with DMR.

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

JACC Cardiovasc Interv: 12 Sep 2022; 15:1711-1722
Yoon SH, Makar M, Kar S, Chakravarty T, ... Bax JJ, Makkar RR
JACC Cardiovasc Interv: 12 Sep 2022; 15:1711-1722 | PMID: 36075642
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Clinical Outcomes With Transcatheter Edge-to-Edge Repair in Atrial Functional MR From the EXPAND Study.

Sodhi N, Asch FM, Ruf T, Petrescu A, ... Kar S, Price MJ
Background
Although transcatheter edge-to-edge repair (TEER) has been shown to improve clinical outcomes and improve quality of life in patients with symptomatic secondary mitral regurgitation (SMR) and left ventricular dysfunction, its effect in patients with atrial SMR (aSMR) has not been well described.
Objectives
The aim of this study was to assess the safety, echocardiographic outcomes, and clinical effectiveness of TEER for aSMR.
Methods
Patients with aSMR in the prospective, observational, multicenter EXPAND (A Contemporary, Prospective, Multi-Center Study Evaluating Real-World Experience of Performance and Safety for the Next Generation of MitraClip Devices) study were identified by an echocardiography core laboratory. Follow-up occurred at discharge, 30 days, and 1 year. Key endpoints included mitral regurgitation (MR) severity, functional class, heart failure hospitalizations, mortality, and 30-day major adverse events.
Results
Among 1,041 patients enrolled in EXPAND, 835 patients had evaluable echocardiograms at baseline. Of these, 53 patients had aSMR and 360 had ventricular SMR (vSMR). In the aSMR cohort, TEER resulted in a significant reduction in MR through 1 year (MR grade ≤2 in 100.0%), significantly increased 1-year Kansas City Cardiomyopathy Questionnaire score (+26.6 ± 30.5 points; P < 0.0001), and improved functional class from baseline, similar to the effects among patients with vSMR (MR grade ≤2 in 99.5% at 1 year, 1-year increase in Kansas City Cardiomyopathy Questionnaire score 21.23 ± 24.92 points). Major adverse events at 30 days and leaflet adverse events at 1 year were infrequent in both groups.
Conclusions
In a prospective, real-world, global registry, TEER for aSMR was associated with significant MR reduction and improvement in quality of life and functional class, similar to patients with vSMR. This suggests that TEER may provide clinical benefit in patients with atrial fibrillation with SMR in the setting of heart failure with preserved ejection fraction. (The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices; NCT03502811).

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

JACC Cardiovasc Interv: 12 Sep 2022; 15:1723-1730
Sodhi N, Asch FM, Ruf T, Petrescu A, ... Kar S, Price MJ
JACC Cardiovasc Interv: 12 Sep 2022; 15:1723-1730 | PMID: 36075643
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Transcatheter Edge-to-Edge Repair for Atrial Secondary Mitral Regurgitation.

Tanaka T, Sugiura A, Öztürk C, Vogelhuber J, ... Nickenig G, Weber M
Background
Atrial secondary mitral regurgitation (ASMR) is a subtype of SMR that has a poor prognosis, and thus far, evidence of the therapeutic options for the management of ASMR is limited.
Objectives
This study aimed to investigate the effectiveness of transcatheter edge-to-edge repair (TEER) for ASMR.
Methods
The study retrospectively analyzed consecutive patients who underwent MitraClip at the Heart Center Bonn. ASMR was defined as cases that met all of the following criteria: 1) normal mitral leaflets without organic disorder; 2) left ventricular ejection fraction >50%; and 3) absence of LV enlargement and segmental abnormality. The primary outcome measure was MR reduction to ≤1+, and its predictors were explored in a logistic regression analysis.
Results
Among 415 patients with SMR, 118 patients met the criteria for ASMR (mean age 80 ± 8 years, 39.8% male). The technical success rate was 94.1%, and MR reduction to ≤1+ after TEER was achieved in 94 (79.7%) patients with ASMR. The in-hospital mortality rate was 2.5%. In multivariable logistic analysis, a large left atrial volume index and low leaflet-to-annulus index were associated with a lower incidence of MR reduction to ≤1+ after TEER for ASMR. In addition, the use of a newer generation of the MitraClip systems (NTR/XTR or G4 systems) was associated with a higher incidence of MR reduction to ≤1+.
Conclusions
TEER is a safe and feasible therapeutic option for patients with ASMR. Assessments of left atrial volume index and leaflet-to-annulus index may assist with patient selection for TEER in patients with ASMR.

Copyright © 2022. Published by Elsevier Inc.

JACC Cardiovasc Interv: 12 Sep 2022; 15:1731-1740
Tanaka T, Sugiura A, Öztürk C, Vogelhuber J, ... Nickenig G, Weber M
JACC Cardiovasc Interv: 12 Sep 2022; 15:1731-1740 | PMID: 36075644
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Prospective Multicenter Trial of Pharmacomechanical-Catheter-Directed Thrombolysis with the Bashir Endovascular Catheter for Acute Pulmonary Embolism.

Bashir R, Foster M, Iskander A, Darki A, ... Rosenfield K, Sista AK
Objectives
This study sought to evaluate the efficacy and safety of tissue-plasminogen activator (t-PA) infused via a Pharmacomechanical catheter-directed thrombolysis (PM-CDT) device called the Bashir Catheter in intermediate-risk acute pulmonary embolism (PE) patients.
Background
Catheter-directed thrombolysis (CDT) has been associated with rapid recovery of right ventricular (RV) function. The Bashir catheter was developed for enhanced thrombolysis in large vessels like the pulmonary artery (PA) with lower doses of t-PA.
Methods
Patients with symptoms of acute PE with CT evidence of RV dilatation were enrolled. The Bashir Catheter was used to deliver 7 mgs of t-PA into each PA over 5 hours. The primary efficacy endpoint was the core laboratory assessed change in CTA-derived right ventricular/left ventricular (RV/LV) diameter ratio at 48 hours and the primary safety endpoint was serious adverse events including major bleeding at 72 hours.
Results
At 18 US sites, 109 patients were enrolled. The median device placement time was 15 minutes. At 48 hours after PM-CDT the RV/LV ratio decreased by 0.56 (33.3%: p<0.0001). The PA obstruction as measured by the Refined Modified Miller Index (RMMI) was reduced by 35.9% (p <0.0001). One patient (0.92%) had two serious adverse events (SAE) which included a retroperitoneal bleed (procedure-related) and iliac vein thrombosis (device-related). Two other procedure-related SAEs included epistaxis, and non-access site hematoma with anemia.
Conclusions
PM-CDT with the Bashir endovascular catheter is associated with significant reduction in RV/LV ratio and a very low rate of adverse events or major bleeding in intermediate-risk acute PE patients. The notable finding was a significant reduction in PA obstruction with low dose t-PA. (Recombinant tPA by Endovascular Administration for the treatment of Submassive pulmonary embolism using pharmaco-mechanical Catheter directed thrombolysis for the redUction of thrombus burdEn - The RESCUE Study IDE # G200009 NCT - 04248868).

Copyright © 2022. Published by Elsevier Inc.

JACC Cardiovasc Interv: 09 Sep 2022; epub ahead of print
Bashir R, Foster M, Iskander A, Darki A, ... Rosenfield K, Sista AK
JACC Cardiovasc Interv: 09 Sep 2022; epub ahead of print | PMID: 36121244
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Pulmonary Artery Denervation for Pulmonary Arterial Hypertension: A Sham-Controlled Randomized Trial.

Zhang H, Wei Y, Zhang C, Yang Z, ... Stone GW, Chen SL
Background
WHO Group I pulmonary arterial hypertension (PAH) is a progressive, debilitating disease. Previous observational studies have demonstrated that pulmonary artery denervation (PADN) reduces pulmonary arterial pressures in PAH. However, the safety and effectiveness of PADN have not been established in a randomized trial.
Objectives
We aimed to determine the treatment effects of PADN in Group I PAH patients.
Methods
WHO Group I PAH patients not taking PAH-specific drugs for at least 30 days were enrolled in a multicenter, sham-controlled single-blind, randomized trial. Patients were assigned to receive PADN plus a phosphodiesterase-5 inhibitor (PDE-5i) or a sham procedure plus a PDE-5i. The primary endpoint was the between-group difference in the change in 6-minute walk distance (6MWD) from baseline to 6 months.
Results
Among 128 randomized patients, those treated with PADN compared with sham had a greater improvement in 6MWD from baseline to 6 months (mean adjusted between-group difference 33.8 m, 95% CI, 16.7 to 50.9, p<0.001). From baseline to 6 months PVR was reduced by -3.0 ± 0.3 Wood units after PADN and -1.9 ± 0.3 Wood units after sham (adjusted difference -1.4, 95% CI -2.6 to -0.2). PADN also improved right ventricular function, reduced tricuspid regurgitation and decreased NT-proBNP. Clinical worsening was less (1.6% vs. 313.8%; OR 0.11 , 95% CI 0.01 to 0.87) and a satisfactory clinical response was greater (57.1% vs. 32.3%; OR 2.79 , 95% CI 1.37 to 5.82) with PADN treatment during 6-month follow-up.
Conclusions
In patients with WHO Group I PAH, PADN improved exercise capacity, hemodynamics and clinical outcomes during 6-month follow-up. (ClinicalTrials.gov number: NCT03282266).

Copyright © 2022. Published by Elsevier Inc.

JACC Cardiovasc Interv: 09 Sep 2022; epub ahead of print
Zhang H, Wei Y, Zhang C, Yang Z, ... Stone GW, Chen SL
JACC Cardiovasc Interv: 09 Sep 2022; epub ahead of print | PMID: 36121246
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Transcatheter Aortic Valve Replacement with the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry.

Costa G, Saia F, Pilgrim T, Abdel-Wahab M, ... Tamburino C, Barbanti M
Background
The latest iterations of devices for transcatheter aortic valve replacement (TAVR) have brought refinements to further improve patient outcomes.
Objectives
This study sought to compare early outcomes of patients undergoing TAVR with the self-expanding (SE) Evolut PRO/PRO+ or balloon-expandable (BE) Sapien 3 ULTRA devices.
Methods
The OPERA-TAVI registry collected data from 14 high-volume centers worldwide on patients undergoing TAVR with SE or BE devices. After excluding patients who were not eligible to both devices, patients were compared using 1:1 propensity score matching. The primary efficacy and safety outcomes were VARC-3 device success and early safety, respectively.
Results
Among 2,241 patients eligible for the present analysis, 683 pairs of patients were matched. The primary efficacy outcome did not differ between patients receiving SE or BE transcatheter aortic valves (SE: 87.4% vs BE: 85.9%; P = 0.47), but BE device recipients showed a higher rate of the primary safety outcome (SE: 69.1% vs BE: 82.6%; P < 0.01). This finding was driven by the higher rates of permanent pacemaker implantation (PPI) (SE: 17.9% vs BE: 10.1%; P < 0.01) and disabling stroke (SE: 2.3% vs BE: 0.7%; P = 0.03) in SE device recipients. On post-TAVR echocardiography, the rate of moderate-to-severe paravalvular regurgitation was similar between groups (SE: 3.2% vs BE: 2.3%; P = 0.41), whereas lower mean transvalvular gradients were observed in the SE cohort (median SE: 7.0 vs BE: 12.0 mm Hg; P < 0.01).
Conclusions
The OPERA-TAVI registry showed that SE and BE devices had comparable VARC-3 device success rates, but the BE device had a higher rate of early safety. The higher PPI and disabling stroke rates in SE device recipients drove this composite endpoint.

Copyright © 2022. Published by Elsevier Inc.

JACC Cardiovasc Interv: 08 Sep 2022; epub ahead of print
Costa G, Saia F, Pilgrim T, Abdel-Wahab M, ... Tamburino C, Barbanti M
JACC Cardiovasc Interv: 08 Sep 2022; epub ahead of print | PMID: 36121242
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients.

Lim DS, Smith RL, Gillam LD, Zahr F, ... Hausleiter J, CLASP IID Pivotal Trial Investigators
Background
Severe symptomatic degenerative mitral regurgitation (DMR) has a poor prognosis in the absence of treatment, and new transcatheter options are emerging.
Objectives
The CLASP IID randomized trial (NCT03706833) is the first to evaluate the safety and effectiveness of the PASCAL system compared to the MitraClip system in patients with significant symptomatic DMR. In this report, we present the primary safety and effectiveness endpoints for the trial.
Methods
Patients with 3+ or 4+ DMR at prohibitive surgical risk were assessed by a central screening committee and randomized 2:1 (PASCAL:MitraClip). Study oversight also included an echocardiographic core laboratory and a clinical events committee. The primary safety endpoint was a composite major adverse event (MAE) rate at 30 days. The primary effectiveness endpoint was the proportion of patients with MR ≤2+ at 6 months.
Results
A pre-specified interim analysis in 180 patients demonstrated non-inferiority of the PASCAL system vs. MitraClip system for the primary safety and effectiveness endpoints, MAE: 3.4% vs. 4.8%, MR ≤2+: 96.5% vs. 96.8%, respectively. Functional and quality-of-life outcomes significantly improved in both groups (p<0.05). The proportion of patients with MR ≤1+ was durable in the PASCAL group from discharge to 6 months [PASCAL: 87.2% and 83.7% (p=0.317 vs. discharge); MitraClip: 88.5% and 71.2% (p=0.003 vs. discharge), respectively].
Conclusions
The CLASP IID trial demonstrated safety and effectiveness of the PASCAL system and met non-inferiority endpoints, expanding transcatheter treatment options for prohibitive surgical risk patients with significant symptomatic DMR.

Copyright © 2022. Published by Elsevier Inc.

JACC Cardiovasc Interv: 08 Sep 2022; epub ahead of print
Lim DS, Smith RL, Gillam LD, Zahr F, ... Hausleiter J, CLASP IID Pivotal Trial Investigators
JACC Cardiovasc Interv: 08 Sep 2022; epub ahead of print | PMID: 36121247
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

FFR-Guided PCI Optimization Directed by High-Definition IVUS Versus Standard of Care: The FFR REACT Trial.

Neleman T, van Zandvoort LJC, Tovar Forero MN, Masdjedi K, ... Van Mieghem NM, Daemen J
Background
Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) <0.90 is common and has been related to impaired patient outcome.
Objectives
The authors sought to evaluate if PCI optimization directed by intravascular ultrasound (IVUS) in patients with post-PCI FFR <0.90 could improve 1-year target vessel failure (TVF) rates.
Methods
In this single-center, randomized, double-blind trial, patients with a post-PCI FFR <0.90 at the time of angiographically successful PCI were randomized to IVUS-guided optimization or the standard of care (control arm). The primary endpoint was TVF (a composite of cardiac death, spontaneous target vessel myocardial infarction, and clinically driven target vessel revascularization) at 1 year.
Results
A total of 291 patients with post-PCI FFR <0.90 were randomized (IVUS-guided optimization arm: n = 145/152 vessels, control arm: n = 146/157 vessels). The mean post-PCI FFR was 0.84 ± 0.05. A total of 104 (68.4%) vessels in the IVUS-guided optimization arm underwent additional optimization including additional stenting (34.9%) or postdilatation only (33.6%), resulting in a mean increase in post-PCI FFR in these vessels from 0.82 ± 0.06 to 0.85 ± 0.05 (P < 0.001) and a post-PCI FFR ≥0.90 in 20% of the vessels. The 1-year TVF rate was comparable between the 2 study arms (IVUS-guided optimization arm: 4.2%, control arm: 4.8%; P = 0.79). There was a trend toward a lower incidence of clinically driven target vessel revascularization in the IVUS-guided optimization arm (0.7% vs. 4.2%, P = 0.06).
Conclusions
IVUS-guided post-PCI FFR optimization significantly improved post-PCI FFR. Because of lower-than-expected event rates, post-PCI FFR optimization did not significantly lower TVF at the 1-year follow-up.

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

JACC Cardiovasc Interv: 22 Aug 2022; 15:1595-1607
Neleman T, van Zandvoort LJC, Tovar Forero MN, Masdjedi K, ... Van Mieghem NM, Daemen J
JACC Cardiovasc Interv: 22 Aug 2022; 15:1595-1607 | PMID: 35981832
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

The Effect of Coronary Lesion Complexity and Preprocedural Revascularization on 5-Year Outcomes After TAVR.

Minten L, Wissels P, McCutcheon K, Bennett J, ... Guler I, Dubois C
Background
Aortic stenosis and coronary artery disease (CAD) frequently coincide. However, the management of coexisting CAD in patients undergoing transcatheter aortic valve replacement (TAVR) remains controversial.
Objectives
This study sought to determine whether the presence of CAD, its complexity, and angiography-guided percutaneous coronary intervention (PCI) are associated with outcomes after TAVR.
Methods
All patients undergoing TAVR at a tertiary referral center between 2008 and 2020 were included in a prospective observational study. Baseline SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) score (SS) and, whenever applicable, a residual SS after PCI were calculated. A multivariate analysis was performed to determine the effect of CAD, stratified according to complexity, and PCI on 5-year outcomes.
Results
In 604 patients, the presence of CAD and its complexity were significantly associated with worse 5-year survival (SS 0: 67.9% vs SS 1-22: 56.1% vs SS >22: 53.0%; log-rank P = 0.027) and increased cardiovascular mortality (SS 0: 15.1% vs SS 1-22: 24.0% vs SS >22: 27.8%; log-rank P = 0.024) after TAVR. Having noncomplex CAD (SS 1-22) was an independent predictor for increased all-cause mortality (HR: 1.43; P = 0.046), while complex CAD (SS >22) increased cardiovascular mortality significantly (HR: 1.84; P = 0.041). Angiography-guided PCI or completeness of revascularization was not associated with different outcomes.
Conclusions
The presence of CAD and its anatomical complexity in patients undergoing TAVR are associated with significantly worse 5-year outcomes. However, angiography-guided PCI did not improve outcomes, highlighting the need for further research into physiology-guided PCI.

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

JACC Cardiovasc Interv: 22 Aug 2022; 15:1611-1620
Minten L, Wissels P, McCutcheon K, Bennett J, ... Guler I, Dubois C
JACC Cardiovasc Interv: 22 Aug 2022; 15:1611-1620 | PMID: 35981834
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Prognostic Implications of Quantitative Flow Ratio-Derived Physiological 2-Dimensional Residual Disease Patterns After Stenting.

Dai N, Zhang R, Yuan S, Hu N, ... Xu B, Ge J
Background
Post-percutaneous coronary intervention (PCI) residual disease is associated with clinical outcomes. Nevertheless, the prognostic value of residual disease patterns remains unknown.
Objectives
This study aimed to evaluate clinical implications of 2-dimensional residual disease patterns after PCI.
Methods
One thousand six hundred seven vessels that underwent successful PCI were included. Two-dimensional residual disease patterns were determined by visual assessment or the quantitative flow ratio (QFR)-derived pull back pressure gradient index (with a cutoff value of 0.78 to define predominant focal versus diffuse disease) and instantaneous QFR gradient per unit length (with a cutoff value of ≥0.005/mm to define a major gradient). The clinical outcome was the 2-year vessel-oriented composite outcome (VOCO).
Results
Residual disease patterns were classified into 4 groups: predominant focal without and with a major gradient (group 1 [n = 1,058] and group 2 [n = 63], respectively) and predominant diffuse without and with a major gradient (group 3 [n = 318] and group 4 [n = 168], respectively). At 2 years, VOCO was lowest in group 1 (1.4% vs 5.4% in group 2 vs 4.8% in group 3 vs 8.5% in group 4, all P < 0.05), whereas there was no prognostic value for classifications by visual assessment. Physiological residual disease patterns were independently associated with VOCO and showed increased prognostic value when introduced to a model with clinical risk factors only (C index: 0.77 vs. 0.68, P = 0.008; net reclassification improvement: 0.65, P < 0.001; integrated discrimination improvement: 0.020, P < 0.001).
Conclusions
Objective analysis of post-PCI QFR pull backs using the concept of 2-dimensional residual disease patterns is feasible and superior to visual assessments. The residual disease patterns were independently associated with VOCO at 2 years.

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

JACC Cardiovasc Interv: 22 Aug 2022; 15:1624-1634
Dai N, Zhang R, Yuan S, Hu N, ... Xu B, Ge J
JACC Cardiovasc Interv: 22 Aug 2022; 15:1624-1634 | PMID: 35981836
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Study Evaluating the Use of RenalGuard to Protect Patients at High Risk of AKI.

Mauler-Wittwer S, Sievert H, Ioppolo AM, Mahfoud F, ... Morice MC, Garot P
Background
Contrast-induced nephropathy (CIN) can occur after cardiovascular procedures using contrast media, which is associated with increased morbidity and mortality. RenalGuard is a closed-loop system designed to match intravenous hydration with diuretic-induced diuresis that has shown mixed results in the prevention of CIN in previous randomized controlled trials.
Objectives
The STRENGTH (Study Evaluating the Use of RenalGuard to Protect Patients at High Risk of AKI) study assessed whether RenalGuard (PLC Medical Systems) is superior to standard intravenous hydration for CIN prevention in patients with chronic kidney disease undergoing complex cardiovascular procedures.
Methods
STRENGTH is a multicenter, international, open-label, postmarket, prospective, randomized (1:1) study monitored by the Cardiovascular European Research Center (Massy, France) that included a total of 259 patients with moderate to severe chronic kidney disease (estimated glomerular filtration 15-40 mL/min/m2) requiring a complex coronary, structural, or peripheral procedure with an expected contrast injection of at least 3 times the estimated glomerular filtration rate. Patients were randomized to either RenalGuard or intravenous saline hydration according to current guidelines.
Results
The primary endpoint, the incidence of CIN at day 3 after the procedure, was similar between the 2 groups (17/107 [15.9%] in the RG group vs 15/110 [13.9%] in the control group; P = 0.62). In addition, none of the secondary endpoints differed between the 2 groups.
Conclusions
In high-risk patients undergoing complex cardiovascular interventions in experienced centers, furosemide-induced high urine output with matched hydration using the RenalGuard system did not reduce the risk of CIN and adverse outcomes at 12 months compared with conventional intravenous hydration.

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

JACC Cardiovasc Interv: 22 Aug 2022; 15:1639-1648
Mauler-Wittwer S, Sievert H, Ioppolo AM, Mahfoud F, ... Morice MC, Garot P
JACC Cardiovasc Interv: 22 Aug 2022; 15:1639-1648 | PMID: 35981838
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Sex Difference in Outcomes Following Transcatheter Aortic Valve Replacement in Bicuspid Aortic Stenosis.

He JJ, Xiong TY, Yao YJ, Peng Y, ... Chen M, Feng Y
Background
It is unknown whether the sex difference whereby female transcatheter aortic valve replacement (TAVR) candidates had a lower risk profile, a higher incidence of in-hospital complications, but more favorable short- and long-term survival observed in tricuspid cohorts undergoing TAVR would persist in patients with bicuspid aortic valves (BAVs).
Objectives
The aim of this study was to reexamine the impact of sex on outcomes following TAVR in patients with BAVs.
Methods
In this single-center study, patients with BAVs undergoing TAVR for severe aortic stenosis from 2012 to 2021 were retrospectively included. Baseline characteristics, aortic root anatomy, and in-hospital and 1-year valve hemodynamic status and survival were compared between sexes.
Results
A total of 510 patients with BAVs were included. At baseline, women presented with fewer comorbidities. Men had a greater proportion of Sievers type 1 BAV, higher calcium volumes (549.2 ± 408.4 mm3 vs 920.8 ± 654.3 mm3; P < 0.001), and larger aortic root structures. Women experienced more vascular complications (12.9% vs 4.9%; P = 0.002) and bleeding (11.1% vs 5.3%; P = 0.019) and higher residual gradients (16.9 ± 7.7 mm Hg vs 13.2 ± 6.4 mm Hg; P < 0.001), while men were more likely to undergo second valve implantations during index TAVR (6.3% vs 15.9%; P = 0.001). Death at 1 year was not significantly different between sexes (HR: 1.15; 95% CI: 0.56-2.35; P = 0.70). Bleeding (adjusted HR: 4.62; 95% CI: 1.51-14.12; P = 0.007) was the single independent predictor of 1-year death for women.
Conclusions
In patients with BAVs undergoing TAVR, women presented with fewer comorbidities, while men had a greater proportion of type 1 BAV, more calcification, and larger aortic roots. In-hospital outcomes favored men, with fewer complications except for the need for second valve implantation, but 1-year survival was comparable between sexes.

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

JACC Cardiovasc Interv: 22 Aug 2022; 15:1652-1660
He JJ, Xiong TY, Yao YJ, Peng Y, ... Chen M, Feng Y
JACC Cardiovasc Interv: 22 Aug 2022; 15:1652-1660 | PMID: 35981839
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Impact of Moderate Aortic Stenosis on Long-Term Clinical Outcomes: A Systematic Review and Meta-Analysis.

Coisne A, Scotti A, Latib A, Montaigne D, ... Bauters C, Granada JF
Background
The clinical course of patients with moderate aortic stenosis (AS) remains incompletely defined.
Objectives
This study sought to analyze the clinical course of moderate AS and compare it with other stages of the disease.
Methods
Multiple electronic databases were searched to identify studies on adult moderate AS. Random-effects models were used to derive pooled estimates. The primary endpoint was all-cause death. The secondary endpoints were cardiac death, heart failure, sudden death, and aortic valve replacement.
Results
Among a total of 25 studies (12,143 moderate AS patients, 3.7 years of follow-up), pooled rates per 100 person-years were 9.0 (95% CI: 6.9 to 11.7) for all-cause death, 4.9 (95% CI: 3.1 to 7.5) for cardiac death, 3.9 (95% CI: 1.9 to 8.2) for heart failure, 1.1 (95% CI: 0.8 to 1.5) for sudden death, and 7.2 (95% CI: 4.3 to 12.2) for aortic valve replacement. Meta-regression analyses detected that diabetes (P = 0.019), coronary artery disease (P = 0.017), presence of symptoms (P < 0.001), and left ventricle (LV) dysfunction (P = 0.009) were associated with a significant impact on the overall estimate of all-cause death. All-cause mortality was higher in patients with reduced LV ejection fraction (<50%) than with normal LV ejection fraction: 16.5 (95% CI: 5.2 to 52.3) and 4.2 (95% CI: 1.4 to 12.8) per 100 person-years, respectively. Compared with moderate AS, the incidence rate difference of all-cause mortality was -3.9 (95% CI: -6.7 to -1.1) for no or mild AS and +2.2 (95% CI: +0.8 to +3.5) for severe AS patients.
Conclusions
Moderate AS appears to be associated with a mortality risk higher than no or mild AS but lower than severe AS, which increases in specific population subsets. The impact of early intervention in moderate AS patients having high-risk features deserves further investigation.

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

JACC Cardiovasc Interv: 22 Aug 2022; 15:1664-1674
Coisne A, Scotti A, Latib A, Montaigne D, ... Bauters C, Granada JF
JACC Cardiovasc Interv: 22 Aug 2022; 15:1664-1674 | PMID: 35981841
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Unveiling Cardiac Amyloidosis, its Characteristics, and Outcomes Among Patients With MR Undergoing Transcatheter Edge-to-Edge MV Repair.

Donà C, Nitsche C, Koschutnik M, Heitzinger G, ... Goliasch G, Mascherbauer J
Background
Mitral regurgitation (MR) and cardiac amyloidosis (CA) both primarily affect older patients. Data on coexistence and prognostic implications of MR and CA are currently lacking.
Objectives
This study sought to identify the prevalence, clinical characteristics, and outcomes of MR CA compared with lone MR.
Methods
Consecutive patients undergoing transcatheter edge-to-edge repair (TEER) for MR at 2 sites were screened for concomitant CA using a multiparametric approach including core laboratory 99mTc-3,3-diphosphono-1,2-propanodicarboxylic acid bone scintigraphy and echocardiography and immunoglobulin light chain assessment. Transthyretin CA (ATTR) was diagnosed by 99mTc-3,3-diphosphono-1,2-propanodicarboxylic acid (Perugini grade 1: early infiltration; grades 2/3: clinical CA) and the absence of monoclonal protein, and light chain (AL) CA via tissue biopsy. All-cause mortality and hospitalization for heart failure (HHF) served as the endpoints.
Results
A total of 120 patients (age 76.9 ± 8.1 years, 55.8% male) were recruited. Clinical CA was diagnosed in 14 patients (11.7%; 12 ATTR, 1 AL, and 1 combined ATTR/AL) and early amyloid infiltration in 9 patients (7.5%). Independent predictors of MR CA were increased posterior wall thickness and the presence of a left anterior fascicular block on electrocardiography. Procedural success and periprocedural complications of TEER were similar in MR CA and lone MR (P for all = NS). After a median of 1.7 years, 25.8% had experienced death and/or HHF. MR CA had worse outcomes compared with lone MR (HR: 2.2; 95% CI: 1.0-4.7; P = 0.034), driven by a 2.5-fold higher risk for HHF (HR: 2.5; 95% CI: 1.1-5.9), but comparable mortality (HR: 1.6; 95% CI: 0.4-6.1).
Conclusions
Dual pathology of MR CA is common in elderly patients with MR undergoing TEER and has worse postinterventional outcomes compared with lone MR.

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

JACC Cardiovasc Interv: 17 Aug 2022; epub ahead of print
Donà C, Nitsche C, Koschutnik M, Heitzinger G, ... Goliasch G, Mascherbauer J
JACC Cardiovasc Interv: 17 Aug 2022; epub ahead of print | PMID: 36008266
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Acute Kidney Injury Following Tricuspid Transcatheter Edge-to-Edge Repair.

Tanaka T, Kavsur R, Sugiura A, Haurand JM, ... Horn P, Zachoval C
Background
Little is known about the incidence and clinical relevance of postprocedural acute kidney injury (AKI) in patients undergoing transcatheter edge-to-edge repair (TEER) for tricuspid regurgitation (TR).
Objectives
The aim of this study was to investigate the prognostic impact of postprocedural AKI following TEER for TR.
Methods
Two hundred sixty-eight patients who underwent TEER for TR at 2 centers were retrospectively analyzed. Postprocedural AKI was defined as an increase in serum creatinine of ≥0.3 mg/dL within 48 hours or ≥50% within 7 days after the procedure compared with baseline. The association between AKI and the composite outcome, consisting of all-cause mortality and rehospitalization for heart failure within 1 year after the procedure, was determined.
Results
The mean age of the patients was 79.0 ± 6.8 years, and 43.3% were men. Postprocedural AKI occurred in 42 patients (15.7%). Age, male sex, an estimated glomerular filtration rate of <60 mL/min/1.73 m2, and absence of procedural success were associated with the occurrence of AKI. Patients with AKI had a higher incidence of in-hospital mortality than those without AKI (9.5% vs 0.9%; P = 0.006). Moreover, AKI was associated with the incidence of the composite outcome within 1 year after TEER for TR (adjusted HR: 2.39; 95% CI: 1.45-3.94; P = 0.001).
Conclusions
Postprocedural AKI occurred in 15.7% of patients undergoing TEER for TR, despite the absence of iodinated contrast agents, which was associated with worse clinical outcomes. These findings highlight the clinical impact of AKI following TEER for TR and should help in identifying patients at high risk for AKI.

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

JACC Cardiovasc Interv: 11 Aug 2022; epub ahead of print
Tanaka T, Kavsur R, Sugiura A, Haurand JM, ... Horn P, Zachoval C
JACC Cardiovasc Interv: 11 Aug 2022; epub ahead of print | PMID: 36008268
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Supraventricular Arrhythmia Following Patent Foramen Ovale Percutaneous Closure.

Guedeney P, Laredo M, Zeitouni M, Hauguel-Moreau M, ... Silvain J, Montalescot G
Background
Randomized studies have reported low rates of atrial fibrillation (AF) after patent foramen ovale (PFO) closure (<6%) but have relied on patient-reported symptomatic episodes, so the true incidence and timing of AF after PFO closure remain unknown.
Objectives
The aim of this study was to prospectively determine the incidence, timing, and determinants of supraventricular arrhythmia following PFO closure on the basis of loop recorder monitoring.
Methods
Cardiac monitoring was proposed to all patients after PFO closure from June 2018 to October 2021 at a single center by means of implantable loop recorder monitoring in patients considered at higher risk for AF (age ≥ 55 years, associated cardiovascular risk factors, prior palpitations, or documented supraventricular ectopic activity) or 4-week external loop recorder monitoring in other patients. The primary endpoint was the incidence of AF, atrial flutter, or supraventricular tachycardia lasting >30 seconds within 28 days of the procedure. Determinants of the primary endpoint were assessed using a stepwise logistic regression model.
Results
A total of 225 patients were included. The primary endpoint occurred in 47 patients (20.9%), including 13 (9.9%) and 24 (28.9%) among patients monitored with external loop recorders and implantable loop recorders, respectively. Overall, the median delay from procedure to arrhythmia was 14.0 days (IQR, 6.5-19.0 days), and one-half of these patients reported symptomatic episodes. Determinants of the primary endpoint were older age (adjusted OR: 1.67 per 10-year increase; 95% CI: 1.18-2.36), device left disc diameter ≥25 mm (adjusted OR: 2.67; 95% CI: 1.19-5.98) and male sex (adjusted OR: 4.78; 95% CI: 1.96-11.66).
Conclusions
Using loop recorder monitoring for ≥28 days, supraventricular arrhythmia was diagnosed in 1 in 5 patients, with a median delay of 14 days, suggesting that this postprocedural event has so far been underestimated.

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

JACC Cardiovasc Interv: 11 Aug 2022; epub ahead of print
Guedeney P, Laredo M, Zeitouni M, Hauguel-Moreau M, ... Silvain J, Montalescot G
JACC Cardiovasc Interv: 11 Aug 2022; epub ahead of print | PMID: 36008269
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Gender Differences in 10-Year Outcomes Following STEMI: A Subanalysis From the EXAMINATION-EXTEND Trial.

Gabani R, Spione F, Arevalos V, Grima Sopesens N, ... Sabaté M, Brugaletta S
Background
Short-term outcomes following ST-segment elevation myocardial infarction (STEMI) in women are worse than in men, with a higher mortality rate. It is unknown whether gender plays a role in very long term outcomes.
Objectives
The aim of this study was to assess whether very long term outcomes following STEMI treatment are influenced by gender.
Methods
EXAMINATION-EXTEND (10-Year Follow-Up of the EXAMINATION Trial) was an investigator-driven 10-year follow-up of the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial, which randomly 1:1 assigned 1,498 patients with STEMI to receive either everolimus-eluting stents or bare-metal stents. The present study was a subanalysis according to gender. The primary endpoint was the composite patient-oriented endpoint (all-cause death, any myocardial infarction, or any revascularization) at 10 years. Secondary endpoints were individual components of the primary endpoint. All endpoints were adjusted for age.
Results
Among 1,498 patients with STEMI, 254 (17%) were women. Overall, women were older, with more arterial hypertension and less smoking history than men. At 10 years, no difference was observed between women and men for the patient-oriented composite endpoint (40.6% vs 34.2%; adjusted HR: 1.14; 95% CI: 0.91-1.42; P = 0.259). There was a trend toward higher all-cause death in women vs men (27.6% vs 19.4%; adjusted HR: 1.30; 95% CI: 0.99-1.71; P = 0.063), with no difference in cardiac death or other endpoints.
Conclusions
At very long term follow-up, there were no differences in the combined patient-oriented endpoint between women and men, with a trend toward higher all-cause death in women not driven by cardiac death. The present findings underline the need for focused personalized medicine in women after percutaneous revascularization aimed at both cardiovascular and gender-specific risk factor control and targeted treatment. (10-Years Follow-Up of the EXAMINATION Trial [EXAMINAT10N]; NCT04462315).

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

JACC Cardiovasc Interv: 10 Aug 2022; epub ahead of print
Gabani R, Spione F, Arevalos V, Grima Sopesens N, ... Sabaté M, Brugaletta S
JACC Cardiovasc Interv: 10 Aug 2022; epub ahead of print | PMID: 36008267
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Rationale, Definitions, Techniques, and Outcomes of Commissural Alignment in TAVR: From the ALIGN-TAVR Consortium.

Tang GHL, Amat-Santos IJ, De Backer O, Avvedimento M, ... Tarantini G, Søndergaard L
Given the expanding indications of transcatheter aortic valve replacement (TAVR) in younger patients with longer life expectancies, the ability to perform postprocedural coronary access represents a priority in their lifetime management. A growing body of evidence suggests that commissural (and perhaps coronary) alignment in TAVR impacts coronary access and valve hemodynamics as well as coronary flow and access after redo-TAVR. Recent studies have provided modified delivery system insertion and rotation techniques to obtain commissural alignment with available transcatheter heart valve devices. Moreover, patient-specific preprocedural planning and postprocedural imaging tools have been developed to facilitate and evaluate commissural alignment. Future efforts should aim to refine transcatheter heart valve and delivery system designs to make neocommissural alignment easier and more reproducible. The aim of this review is to present an in-depth insight of commissural alignment in TAVR, including its rationale, standardized definitions, technical steps, outcomes, and future directions.

© 2022 by the American College of Cardiology Foundation. Published by Elsevier.

JACC Cardiovasc Interv: 08 Aug 2022; 15:1497-1518
Tang GHL, Amat-Santos IJ, De Backer O, Avvedimento M, ... Tarantini G, Søndergaard L
JACC Cardiovasc Interv: 08 Aug 2022; 15:1497-1518 | PMID: 35926918
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Coronary Access Following Redo TAVR: Impact of THV Design, Implant Technique, and Cell Misalignment.

Meier D, Akodad M, Landes U, Barlow AM, ... Sellers SL, Sathananthan J
Background
The implications and potential challenges of coronary access after redo transcatheter aortic valve replacement (TAVR) are unknown.
Objectives
The authors sought to evaluate the impact of different transcatheter heart valve (THV) designs, neoskirt height, implant technique, and cell misalignment on coronary access after redo TAVR.
Methods
Different THV designs (Sapien 3 [Edwards Lifesciences LLC], Evolut Pro [Medtronic], ACURATE neo [Boston Scientific Corporation], and Portico [Abbott Structural Heart]) and sizes were implanted inside Sapien XT (Edwards Lifesciences LLC) and Evolut R (Medtronic) THVs, which were modeled as the \"failed\" THVs, at different implant depths. Valve combinations underwent micro-computed tomography to determine the neoskirt height and dimensions of the lowest accessible cell for potential coronary access. This was compared with dimensions of 6-F/7-F/8-F coronary guiding catheters.
Results
Redo TAVR combinations resulted in a wide range of neoskirt heights (15.4-31.6 mm) and a variable diameter of the lowest accessible cell (1.9-21.8 mm). An ACURATE neo implanted in a Sapien XT resulted in the largest accessible cells, whereas a Portico implanted in a Sapien XT resulted in the lowest neoskirt heights. The smallest accessible cell was observed in the Evolut Pro-in-Evolut R configuration with higher neoskirt heights. Redo TAVR in a tall frame valve with supra-annular leaflets caused a taller neoskirt height. In Evolut-in-Evolut combinations, misalignment of the cells of the 2 THVs reduced the cell area by 30% to 50% compared with an aligned configuration.
Conclusions
This study demonstrates that different redo TAVR combinations are not equivalent in terms of future coronary access. Redo TAVR using a tall frame valve in a failed tall frame valve and misaligned cells may lead to potentially challenging coronary access.

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

JACC Cardiovasc Interv: 08 Aug 2022; 15:1519-1531
Meier D, Akodad M, Landes U, Barlow AM, ... Sellers SL, Sathananthan J
JACC Cardiovasc Interv: 08 Aug 2022; 15:1519-1531 | PMID: 35926919
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Impact of Commissural Misalignment on Hydrodynamic Function Following Valve-in-Valve Intervention With the ACURATE neo.

Meier D, Akodad M, Chatfield AG, Lutter G, ... Sellers SL, Sathananthan J
Background
Limited evidence is available regarding valve-in-valve (VIV) intervention with the ACURATE neo transcatheter heart valve (THV). Low implantation has demonstrated leaflet interaction between the surgical bioprosthesis and the THV, leading to impaired hydrodynamic performance. It is unknown if commissural alignment (CA) can affect this phenomenon. Novel techniques have now been developed to achieve CA with the ACURATE neo THV.
Objectives
The aim of this study was to assess the impact of commissural misalignment (CMA) on hydrodynamic function following VIV intervention with the ACURATE neo THV using a bench model.
Methods
VIV intervention was performed with the ACURATE neo (a self-expanding THV with supra-annular leaflet position) implanted deep in the surgical bioprosthetic aortic valve (Mitroflow). Hydrodynamic function at CA (0°) and 3 different degrees of CMA (30°, 60°, and 90°) was tested. As per the International Organization for Standardization, a regurgitant fraction <20% is considered optimal.
Results
Following VIV, the central THV regurgitant fraction at 0°, 30°, 60°, and 90° of CMA was 8.6% ± 2.0%, 30.3% ± 12.0%, 42.6% ± 11.9%, and 66.7% ± 25.4% (P < 0.0001), respectively. On high-speed video there was no evidence of leaflet interaction at CA, whereas at 30°, 60°, and 90° of CMA there was clear evidence of THV leaflet interaction with those of the surgical valve, leading to impaired leaflet closure and to severe central THV regurgitation.
Conclusions
In VIV using the ACURATE neo THV at deep implantation, increasing degree of CMA was associated with THV leaflet interaction with those of the surgical valve and worsening regurgitant fraction. THV leaflet interaction was prevented when there was CA.

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

JACC Cardiovasc Interv: 08 Aug 2022; 15:1532-1539
Meier D, Akodad M, Chatfield AG, Lutter G, ... Sellers SL, Sathananthan J
JACC Cardiovasc Interv: 08 Aug 2022; 15:1532-1539 | PMID: 35926920
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Outcomes of Redo Transcatheter Aortic Valve Replacement According to the Initial and Subsequent Valve Type.

Landes U, Richter I, Danenberg H, Kornowski R, ... Leon MB, Webb JG
Background
As transcatheter aortic valve (TAV) replacement is increasingly used in patients with longer life expectancy, a sizable proportion will require redo TAV replacement (TAVR). The unique configuration of balloon-expandable TAV (bTAV) vs a self-expanding TAV (sTAV) potentially affects TAV-in-TAV outcome.
Objectives
The purpose of this study was to better inform prosthesis selection, TAV-in-TAV outcomes were assessed according to the type of initial and subsequent TAV.
Methods
Patients from the Redo-TAVR registry were analyzed using propensity weighting according to their initial valve type (bTAV [n = 115] vs sTAV [n = 106]) and subsequent valve type (bTAV [n = 130] vs sTAV [n = 91]).
Results
Patients with failed bTAVs presented later (vs sTAV) (4.9 ± 2.1 years vs 3.7 ± 2.3 years; P < 0.001), with smaller effective orifice area (1.0 ± 0.7 cm2 vs 1.3 ± 0.8 cm2; P = 0.018) and less frequent dominant regurgitation (16.2% vs 47.3%; P < 0.001). Mortality at 30 days was 2.3% (TAV-in-bTAV) vs 0% (TAV-in-sTAV) (P = 0.499) and 1.7% (bTAV-in-TAV) vs 1.0% (sTAV-in-TAV) (P = 0.612); procedural safety was 72.6% (TAV-in-bTAV) vs 71.2% (TAV-in-sTAV) (P = 0.817) and 73.2% (bTAV-in-TAV) vs 76.5% (sTAV-in-TAV) (P = 0.590). Device success was similar according to initial valve type but higher with subsequent sTAV vs bTAV (77.2% vs 64.3%; P = 0.045), primarily because of lower residual gradients (10.3 mm Hg [8.9-11.7 mm Hg] vs 15.2 mm Hg [13.2-17.1 mm Hg]; P < 0.001). Residual regurgitation (moderate or greater) was similar after bTAV-in-TAV and sTAV-in-TAV (5.7%) and nominally higher after TAV-in-bTAV (9.1%) vs TAV-in-sTAV (4.4%) (P = 0.176).
Conclusions
In selected patients, no association was observed between TAV type and redo TAVR safety or mortality, yet subsequent sTAV was associated with higher device success because of lower redo gradients. These findings are preliminary, and more data are needed to guide valve choice for redo TAVR.

Copyright © 2022. Published by Elsevier Inc.

JACC Cardiovasc Interv: 08 Aug 2022; 15:1543-1554
Landes U, Richter I, Danenberg H, Kornowski R, ... Leon MB, Webb JG
JACC Cardiovasc Interv: 08 Aug 2022; 15:1543-1554 | PMID: 35926921
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Appropriate Use of Intravascular Ultrasound During Arterial and Venous Lower Extremity Interventions.

Secemsky EA, Mosarla RC, Rosenfield K, Kohi M, ... Hawkins BM, Parikh SA
Background
There has been growing use of intravascular ultrasound (IVUS) during lower extremity arterial and venous revascularization. Observational data suggest that the use of IVUS can improve periprocedural and long-term outcomes, but largescale prospective data remain limited. Consensus opinion regarding the appropriate use of IVUS during peripheral intervention is needed.
Objectives
The purpose of this consensus document is to provide guidance on the appropriate use of IVUS in various phases of peripheral arterial and venous interventions.
Methods
A 12-member writing committee was convened to derive consensus regarding the appropriate clinical scenarios for use of peripheral IVUS. The group iteratively created a 72-question survey representing 12 lower extremity arterial interventional scenarios. Separately, a 40-question survey representing 8 iliofemoral venous interventional scenarios was constructed. Clinical scenarios were categorized by interventional phases: preintervention, intraprocedure, and postintervention optimization. Thirty international vascular experts (15 for each survey) anonymously completed the survey instrument. Results were categorized by appropriateness using the median value and disseminated to the voting panel to reevaluate for any disagreement.
Results
Consensus opinion concluded that IVUS use may be appropriate during the preintervention phase for evaluating the etiology of vessel occlusion and plaque morphology in the iliac and femoropopliteal arteries. IVUS was otherwise rated as appropriate during iliac and femoropopliteal revascularization in most other preintervention scenarios, as well as intraprocedural and postprocedural optimization phases. IVUS was rated appropriate in all interventional phases for the tibial arteries. For iliofemoral venous interventions, IVUS was rated as appropriate in all interventional phases.
Conclusions
Expert consensus can help define clinical procedural scenarios in which peripheral IVUS may have value during lower extremity arterial and venous intervention while additional prospective data are collected.

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

JACC Cardiovasc Interv: 08 Aug 2022; 15:1558-1568
Secemsky EA, Mosarla RC, Rosenfield K, Kohi M, ... Hawkins BM, Parikh SA
JACC Cardiovasc Interv: 08 Aug 2022; 15:1558-1568 | PMID: 35926922
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Clinical Impact of Intravascular Ultrasound-Guided Fluoropolymer-Based Drug-Eluting Stent Implantation for Femoropopliteal Lesions.

Tsujimura T, Iida O, Takahara M, Soga Y, ... Mano T, CAPSICUM Investigators
Background
Treatment with a fluoropolymer-based drug-eluting stent (FP-DES has been widely applied to the contemporary femoropopliteal practice with durable outcomes. Nevertheless, the impact of intravascular ultrasound (IVUS) utilization on clinical outcomes after FP-DES implantation has not been determined.
Objectives
This study aimed to investigate the impact of IVUS on 1-year clinical outcomes after FP-DES) implantation for femoropopliteal lesions in patients with symptomatic peripheral artery disease.
Methods
As a subanalysis of the CAPSICUM (contemporary outcomes after paclitaxel-eluting peripheral stent implantation for symptomatic lower limb ischemia with superficial femoral or proximal popliteal lesion) study, the present investigation analyzed 1,091 patients with symptomatic peripheral artery disease who underwent endovascular therapy with FP-DES for femoropopliteal lesions. One-year clinical outcomes were compared between patients treated with IVUS and those treated without IVUS after propensity score matching. The primary outcome measure was 1-year restenosis. The incidence of aneurysmal degeneration was also assessed.
Results
A total of 843 (77.2%) patients underwent IVUS-guided FP-DES implantation. After propensity score matching, the 1-year restenosis was not significantly different between the groups (11.5% [95% CI: 9.1%-14.0%] vs 15.5% [95% CI: 10.9%-20.1%]; P = 0.22). The frequency of aneurysmal degeneration at 1 year was significantly higher in the IVUS group than in the non-IVUS group (19.8% [95% CI: 16.3%-23.4%] vs 7.1% [95% CI: 3.3%-11.0%]; P < 0.001). IVUS use was associated with a lower restenosis risk in patients with chronic total occlusion but not in those without (P for interaction = 0.044).
Conclusions
The present study revealed that 1-year restenosis risk was not significantly different between the 2 groups, whereas the incidence of aneurysmal degeneration was significantly higher in the IVUS group.

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

JACC Cardiovasc Interv: 08 Aug 2022; 15:1569-1578
Tsujimura T, Iida O, Takahara M, Soga Y, ... Mano T, CAPSICUM Investigators
JACC Cardiovasc Interv: 08 Aug 2022; 15:1569-1578 | PMID: 35926923
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Transcatheter Coronary Sinus Interventions.

Alkhouli M, Lurz P, Rodés-Cabau J, Gulati R, ... Lerman A, Latib A
The coronary sinus has become a popular route for an increasing number of innovative transcatheter interventions to treat coronary and structural heart diseases. However, interventional cardiologists have limited experience with the cardiac venous system and its highly variable anatomy. In this paper, we review the anatomy of the cardiac veins as it relates to transcatheter interventions. We also provide a contemporary overview of the emerging coronary sinus-based transcatheter therapies and their growing literature.

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

JACC Cardiovasc Interv: 25 Jul 2022; 15:1397-1412
Alkhouli M, Lurz P, Rodés-Cabau J, Gulati R, ... Lerman A, Latib A
JACC Cardiovasc Interv: 25 Jul 2022; 15:1397-1412 | PMID: 35863788
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Predicting Periprocedural Complications in Chronic Total Occlusion Percutaneous Coronary Intervention: The PROGRESS-CTO Complication Scores.

Simsek B, Kostantinis S, Karacsonyi J, Alaswad K, ... Mastrodemos OC, Brilakis ES
Background
Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is associated with increased risk of periprocedural complications. Estimating the risk of complications facilitates risk-benefit assessment and procedural planning.
Objectives
This study sought to develop risk scores for in-hospital major adverse cardiovascular events (MACE), mortality, pericardiocentesis, and acute myocardial infarction (MI) in patients undergoing CTO PCI.
Methods
The study analyzed the PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention; NCT02061436) and created risk scores for MACE, mortality, pericardiocentesis, and acute MI. Logistic regression prediction modeling was used to identify independently associated variables, and models were internally validated with bootstrapping.
Results
The incidence of periprocedural complications among 10,480 CTO PCIs was as follows: MACE 215 (2.05%), mortality 47 (0.45%), pericardiocentesis 83 (1.08%), and acute MI 66 (0.63%). The final model for MACE included ≥65 years of age (1 point), moderate-severe calcification (1 point), blunt stump (1 point), antegrade dissection and re-entry (ADR) (1 point), female (2 points), and retrograde (2 points); the final model for mortality included ≥65 years of age (1 point), left ventricular ejection fraction ≤45% (1 point), moderate-severe calcification (1 point), ADR (1 point), and retrograde (1 point); the final model for pericardiocentesis included ≥65 years of age (1 point), female (1 point), moderate-severe calcification (1 point), ADR (1 point), and retrograde (2 points); the final model for acute MI included prior coronary artery bypass graft surgery (1 point), atrial fibrillation (1 point), and blunt stump (1 point). The C-statistics of the models were 0.74, 0.80, 0.78, 0.72 for MACE, mortality, pericardiocentesis, and acute MI, respectively.
Conclusions
The PROGRESS-CTO complication risk scores can facilitate estimation of the periprocedural complication risk in patients undergoing CTO PCI.

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

JACC Cardiovasc Interv: 25 Jul 2022; 15:1413-1422
Simsek B, Kostantinis S, Karacsonyi J, Alaswad K, ... Mastrodemos OC, Brilakis ES
JACC Cardiovasc Interv: 25 Jul 2022; 15:1413-1422 | PMID: 35863789
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Impact of Subintimal Plaque Modification on Reattempted Chronic Total Occlusions Percutaneous Coronary Intervention.

Zhong X, Gao W, Hu T, Chen J, ... Ge L, Ge J
Background
Predictors of success in reattempted chronic total occlusion (CTO) percutaneous coronary intervention (PCI) procedures remain obscure, mainly owing to the lack of consecutive angiograms and procedural records of initial attempts in the same cohort.
Objectives
This study sought to investigate the factors predicting the success of reattempted CTO PCI procedures.
Methods
A total of 208 consecutive patients who underwent a failed CTO PCI attempt and received reattempted procedure at the same cardiac center were retrospectively analyzed. Predictors of the success of reattempted procedures were evaluated.
Results
The overall technical success rate of reattempted CTO PCI procedures was 71.2%. Subintimal plaque modification (SPM) was implemented in 35 (16.8%) procedures in initial attempts. The reattempted technical success rate was 93.3% in cases in which SPM with guidewire (GW) crossing was achieved in the initial attempt; however, the success rate was 55.0% for procedures involving SPM without GW crossing. SPM with GW crossing (OR: 11.21; 95% CI: 1.31-96.16; P = 0.028), referral to high-volume operators (OR: 2.38; 95% CI: 1.14-4.98; P = 0.021), and a bidirectional approach (OR: 2.31; 95% CI: 1.12-4.79; P = 0.024) were positive independent predictors of technical success in the subsequent reattempt. The time interval for reattempt (per 90-day increment) was negatively correlated with the technical success of the reattempted procedures (OR: 0.85; 95% CI: 0.73-0.98; P = 0.030).
Conclusions
This study identified independent predictors of success in reattempted CTO PCI procedures. SPM with GW crossing achieved in the initial attempt is associated with a higher success rate in the subsequent reattempt.

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

JACC Cardiovasc Interv: 25 Jul 2022; 15:1427-1437
Zhong X, Gao W, Hu T, Chen J, ... Ge L, Ge J
JACC Cardiovasc Interv: 25 Jul 2022; 15:1427-1437 | PMID: 35863791
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Comparative Analysis of Patient Characteristics in Chronic Total Occlusion Revascularization Studies: Trials vs Real-World Registries.

Megaly M, Buda K, Mashayekhi K, Werner GS, ... Brilakis ES, Alaswad K
Background
The few randomized controlled trials (RCTs) on chronic total occlusion (CTO) percutaneous coronary intervention (PCI) are subject to selection bias.
Objectives
The purpose of this study was to evaluate the differences between real-world CTO patients and those enrolled in RCTs.
Methods
This study performed a meta-analysis of national and dedicated CTO PCI registries and compared patient characteristics and outcomes with those of RCTs that randomized patients to CTO PCI versus medical therapy. Given the large sample size differences between RCTs and registries, the study focused on the absolute numbers and their clinical significance. The study considered a 5% relative difference between groups to be potentially clinically relevant.
Results
From 2012 to 2022, 6 RCTs compared CTO PCI versus medical therapy (n = 1,047) and were compared with 15 registries (5 national and 10 dedicated CTO PCI registries). Compared with registry patients, RCT patients had fewer comorbidities, including diabetes, hypertension, previous myocardial infarction, and prior coronary artery bypass graft surgery. RCT patients had shorter CTO length (29.6 ± 19.7 mm vs 32.6 ± 23.0 mm, a relative difference of 9.2%) and lower Japan-Chronic Total Occlusion Score scores (2.0 ± 1.1 vs 2.3 ± 1.2, a relative difference of 13%) compared with those enrolled in dedicated CTO registries. Procedural success was similar between RCTs (84.5%) and dedicated CTO registries (81.4%) but was lower in national registries (63.9%).
Conclusions
There is a paucity of randomized data on CTO PCI outcomes (6 RCTs, n = 1,047). These patients have lower risk profiles and less complex CTOs than those in real-world registries. Current evidence from RCTs may not be representative of real-world patients and should be interpreted within its limitation.

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

JACC Cardiovasc Interv: 25 Jul 2022; 15:1441-1449
Megaly M, Buda K, Mashayekhi K, Werner GS, ... Brilakis ES, Alaswad K
JACC Cardiovasc Interv: 25 Jul 2022; 15:1441-1449 | PMID: 35863793
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

1-Year Outcomes of Thromboendarterectomy vs Endovascular Therapy for Common Femoral Artery Lesions: CAULIFLOWER Study Results.

Nakama T, Takahara M, Iwata Y, Fujimura N, ... Obunai K, CAULIFLOWER Study Investigators
Background
Thromboendarterectomy (TEA) is the gold-standard treatment for common femoral artery (CFA). However, because of its low invasiveness and short hospitalization duration, CFA endovascular therapy (EVT) is performed in real-world practice. However, the clinical benefits and appropriate target population for CFA EVT remain unclear.
Objectives
The aims of this study were to compare the clinical outcomes of TEA with those of EVT in patients with symptomatic CFA diseases and to identify the adequate target population for CFA EVT.
Methods
A total of 1,193 consecutive patients who underwent EVT (n = 761) or TEA (n = 432) for CFA were identified and retrospectively reviewed from a registry of 66 institutions. The primary outcome was 1-year primary patency compared between EVT and TEA using propensity score matching. An interaction analysis was performed to explore the appropriate target population for CFA EVT.
Results
After propensity score matching, the 1-year primary patency rate was significantly higher in the TEA group (82.3% vs 96.6%; P < 0.001), whereas perioperative complications were more frequently observed in the TEA group (P = 0.047). Nonambulatory status attenuated the HR of EVT vs TEA for restenosis risk (P = 0.021), whereas the presence of nodular calcification significantly increased the HR (P = 0.040). In the EVT subgroup analysis for restenosis risk, stent use showed the lowest HR compared with plain balloon angioplasty and drug-coated balloon angioplasty (P < 0.001).
Conclusions
TEA showed superior 1-year patency compared with EVT in a nationwide multicenter study. Nonambulatory status attenuated the superiority, whereas the presence of nodular calcification enhanced it.

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

JACC Cardiovasc Interv: 25 Jul 2022; 15:1453-1463
Nakama T, Takahara M, Iwata Y, Fujimura N, ... Obunai K, CAULIFLOWER Study Investigators
JACC Cardiovasc Interv: 25 Jul 2022; 15:1453-1463 | PMID: 35863795
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Impact of High Lipoprotein(a) Levels on Clinical Outcomes Following Peripheral Endovascular Therapy.

Tomoi Y, Takahara M, Soga Y, Kodama K, ... Hiramori S, Ando K
Background
Elevated lipoprotein(a) (Lp[a]) levels are an independent risk factor for the development of atherosclerotic diseases, including peripheral artery disease (PAD). However, their prognostic impact in patients with PAD remains unknown.
Objectives
The aim of this study was to examine the prognostic impact of elevated Lp(a) levels in patients with PAD undergoing endovascular therapy (EVT).
Methods
In total, 1,169 patients who underwent successful EVT for symptomatic PAD between September 2016 and August 2021 were included in this study. High Lp(a) levels were defined as >30 mg/dL. The associations of high Lp(a) levels with incident major adverse cardiovascular events (MACE) (all-cause death, myocardial infarction, and stroke) and major adverse limb events (MALE) (repeat revascularization for target limb and major amputation) were analyzed.
Results
During a median follow-up period of 1.7 years (IQR: 0.6-3.0 years), 230 MACE (210 deaths, 15 myocardial infarctions, and 22 strokes) and 263 MALE (219 reinterventions and 36 major amputations) were observed. The cumulative incidence rate of MACE (48.1% vs 27.3%) and MALE (67.9% vs 27.2%) was significantly higher in patients with high Lp(a) levels (P < 0.001 for both). The adjusted HR were 1.93 (95% CI: 1.44-2.59; P < 0.001) for MACE and 4.15 (95% CI: 3.14-5.50; P < 0.001) for MALE. These associations were not influenced by low-density lipoprotein cholesterol levels or statin administration (P for interaction >0.05 for all).
Conclusions
Elevated Lp(a) levels were independently associated with incident MACE and MALE in patients with PAD treated with revascularization irrespective of low-density lipoprotein cholesterol level and statin administration.

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

JACC Cardiovasc Interv: 25 Jul 2022; 15:1466-1476
Tomoi Y, Takahara M, Soga Y, Kodama K, ... Hiramori S, Ando K
JACC Cardiovasc Interv: 25 Jul 2022; 15:1466-1476 | PMID: 35863797
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

3-Year Outcomes After 2-Stent With Provisional Stenting for Complex Bifurcation Lesions Defined by DEFINITION Criteria.

Kan J, Zhang JJ, Sheiban I, Santoso T, ... Chen SL, DEFINITION II Investigators
Background
The multicenter and randomized DEFINITION II (Two-Stent vs Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions) trial showed less 1-year target lesion failure (TLF) after a 2-stent approach for complex coronary bifurcation lesions compared with provisional stenting (PS). The authors report the 3-year clinical outcome of the DEFINITION II trial.
Objectives
The aim of the present study was to investigate the difference in TLF at 3 years after a planned 2-stent approach vs PS for complex coronary bifurcation lesions stratified by DEFINITION (Definitions and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents) criteria.
Methods
A total of 653 patients with complex coronary bifurcation lesions were randomly assigned to either the 2-stent group or the PS group in the DEFINITION II trial and were followed for 3 years. The primary endpoint was the occurrence of TLF at 3 years. Stent thrombosis was the safety endpoint.
Results
At 3 years, TLF had occurred in 52 patients (16.0%) in the PS group and in 34 (10.4%) patients in the 2-stent group (HR: 0.63; 95% CI: 0.41-0.97; P = 0.035), driven mainly by increased target vessel myocardial infarction (8.0% vs 3.7%; HR: 0.45; 95% CI: 0.23-0.89; P = 0.022) and target lesion revascularization (8.3% vs 4.3%; HR: 0.50; 95% CI: 0.26-0.96; P = 0.038). There was no difference in TLF between the 2 groups between year 1 and year 3.
Conclusions
For patients with complex coronary bifurcations who reach 1-year postprocedure without experiencing endpoint events, there is still a risk for future events. The type of procedure performed initially is no longer a future event risk determinant. (Two-Stent vs Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions; NCT02284750).

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

JACC Cardiovasc Interv: 11 Jul 2022; 15:1310-1320
Kan J, Zhang JJ, Sheiban I, Santoso T, ... Chen SL, DEFINITION II Investigators
JACC Cardiovasc Interv: 11 Jul 2022; 15:1310-1320 | PMID: 35798473
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Ultrathin, Biodegradable-Polymer Sirolimus-Eluting Stent vs Thin, Durable-Polymer Everolimus-Eluting Stent.

Nakamura M, Kadota K, Nakagawa Y, Tanabe K, ... Murakami Y, CASTLE Investigators
Background
Previous trials suggested the superiority of ultrathin- over thin-strut drug-eluting stents (DES) concerning target lesion failure (TLF) at 1 year after index percutaneous coronary intervention.
Objectives
The aim of this randomized comparison study of ultrathin-strut and thin-strut DES (CASTLE [Randomized Comparison All-Comer Study of Ultrathin Strut and Thin Strut Drug-Eluting Stent]; jRCTs032180084) was to examine the impact of differences in strut thickness of DES on clinical outcomes when implanted with angiography and intravascular ultrasound or optical coherence tomographic guidance.
Methods
CASTLE was a multicenter, prospective, noninferiority study conducted at 65 institutions in Japan. Percutaneous coronary intervention patients were assigned (1:1) to an ultrathin, biodegradable-polymer sirolimus-eluting stent (BP-SES) or a thin, durable-polymer everolimus-eluting stent (DP-EES). The primary endpoint was TLF, defined as a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target lesion revascularization at 1-year follow-up.
Results
Between May 2019 and March 2020, 1,440 patients were randomly assigned to BP-SES (n = 722) or DP-EES (n = 718). TLF occurred in 6.0% and 5.7% of patients, respectively. Noninferiority (P = 0.040) was met because the upper limit (2.67%) of the 1-sided 95% CI between the groups was lower than the prespecified noninferiority margin (3.3%). No significant interactions were observed in the relative rates of TLF between prespecified subgroups.
Conclusions
The BP-SES was noninferior to the DP-EES regarding 1-year TLF. This demonstrates that strut thickness differences among DES have little impact on clinical outcomes when implanted with intravascular imaging guidance.

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

JACC Cardiovasc Interv: 11 Jul 2022; 15:1324-1334
Nakamura M, Kadota K, Nakagawa Y, Tanabe K, ... Murakami Y, CASTLE Investigators
JACC Cardiovasc Interv: 11 Jul 2022; 15:1324-1334 | PMID: 35798475
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Comparative Outcomes After Percutaneous Coronary Intervention in Unconscious and Conscious Patients With Out-of-Hospital Cardiac Arrest.

Spirito A, Papadis A, Vaisnora L, Iacovelli F, ... Räber L, Valgimigli M
Background
Up to 70% of out-of-hospital cardiac arrest (OHCA) patients have a relevant coronary stenosis which may need revascularization. The short- and long-term ischemic and bleeding risk of unconscious and conscious OHCA patients undergoing percutaneous coronary intervention (PCI) is largely unknown.
Objectives
This study sought to compare the occurrence of 1-year outcomes after PCI between OHCA patients, stratified on the basis of state of consciousness, with patients with acute coronary syndrome (ACS) not preceded by OHCA.
Methods
The study assessed the unadjusted and adjusted risk of cardiovascular events in a prospective single-center cohort of 9,303 consecutive PCI patients.
Results
At 1 year, all-cause mortality was higher in unconscious (49.5%) but not in conscious OHCA (8.9%) patients than in ACS patients (8.0%), and both unconscious and conscious OHCA patients were more likely than ACS patients to experience definite stent thrombosis (4.4% and 3.5% vs 1.3%) and Bleeding Academic Research Consortium 3 or 5 bleeding (17.8% and 9.0% vs 5.1%). The higher hazards were largely determined by events occurring in the first 30 days. After multivariable adjustment, only unconscious OHCA patients remained at increased risk of death (adjusted HR: 3.27; 95% CI: 2.65-4.05), definite stent thrombosis (adjusted HR: 2.40; 95% CI: 1.30-4.43), and Bleeding Academic Research Consortium 3 or 5 bleeding (adjusted HR: 2.51; 95% CI: 1.82-3.47) at 1 year.
Conclusions
At 1 year after PCI, unconscious OHCA patients were at higher risk of death, definite stent thrombosis, and bleeding, while conscious OHCA patients had similar hazards compared with an all-comer ACS population without OHCA. Dedicated PCI strategies for OHCA patients taking into account their state of consciousness after resuscitation are warranted.

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

JACC Cardiovasc Interv: 11 Jul 2022; 15:1338-1348
Spirito A, Papadis A, Vaisnora L, Iacovelli F, ... Räber L, Valgimigli M
JACC Cardiovasc Interv: 11 Jul 2022; 15:1338-1348 | PMID: 35798477
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Multicenter Experience With the Transcatheter Leaflet Repair System for Symptomatic Tricuspid Regurgitation.

Wild MG, Löw K, Rosch S, Gerçek M, ... Hausleiter J, PASTE Investigators
Background
Transcatheter treatment techniques for tricuspid regurgitation (TR) have evolved in recent years, with leaflet repair being the most commonly used, but thus far evidence on the PASCAL and PASCAL Ace system is based mainly on compassionate use data.
Objectives
This is the first report on commercial use in a multicenter study with a large patient cohort investigating the safety and efficacy of the PASCAL and PASCAL Ace system in the treatment of TR.
Methods
In a retrospective, multicenter, observational setting, data from all consecutive patients undergoing leaflet repair for TR at 8 centers was collected, including a centralized analysis of echocardiographic data.
Results
A total of 235 high-risk patients (mean age 78 ± 8 years, 49% women, mean Society of Thoracic Surgeons Predicted Risk of Mortality score 8.6% ± 6.8%) were included. TR was functional in 87% of patients and graded severe or higher in 91%. TR was successfully reduced to moderate or less in 78% of patients (P < 0.001). Procedural success was 78% (n = 153). At the latest available follow-up (median 173 days), TR reduction was sustained (78% with TR moderate or less; P < 0.001), and echocardiography showed indications of right ventricular remodeling (mean right ventricular end-diastolic diameter 56 ± 9 mm vs 53 ± 9 mm; P < 0.001). Patients\' symptoms diminished significantly (63% were in New York Heart Association functional class I or II at follow-up; P < 0.001). In a device-specific analysis, the PASCAL and PASCAL Ace showed no difference in TR reduction (postprocedural TR moderate or less in 77% vs 78%; P = 0.82).
Conclusions
In early clinical experience, the PASCAL (Ace) leaflet repair system has high technical and procedural success rates with efficient TR reduction and significant clinical and echocardiographic improvement at follow-up.

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

JACC Cardiovasc Interv: 11 Jul 2022; 15:1352-1363
Wild MG, Löw K, Rosch S, Gerçek M, ... Hausleiter J, PASTE Investigators
JACC Cardiovasc Interv: 11 Jul 2022; 15:1352-1363 | PMID: 35798479
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:

This program is still in alpha version.