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The blood pressure (BP) lowering response to renal denervation (RDN) remains variable with about one-third of patients not responding to ultrasound or radiofrequency RDN. Identification of predictors of the BP response to RDN is needed to optimize patient selection for this therapy. This is a post-hoc analysis of the RADIANCE-HTN SOLO study. BP response to RDN was measured by the change in daytime ambulatory systolic blood pressure (dASBP) at 2 months post procedure. Univariate regression was used initially to assess potential predictors of outcome followed by multivariate regression analysis. In the univariate analysis, predictors of response to RDN were higher baseline daytime ambulatory diastolic blood pressure (dADBP), the use of antihypertensive medications at screening, and presence of orthostatic hypertension (OHTN) whilst the presence of untreated accessory arteries was a negative predictor of response. Multivariate analysis determined that dADBP and use of antihypertensive medications were predictors of response to RDN with a trend for OHTN to predict response. Obese females also appeared to be better responders to RDN in an interaction model. RDN is more effective in patients with elevated baseline dADBP and those with OHTN, suggesting increased peripheral vascular resistance secondary to heightened sympathetic tone. These assessments are easy to perform in clinical setting and may help in phenotyping patients who will respond better to RDN., (© 2021. The Author(s).)

Background: Positive near-infrared spectroscopy (NIRS) signals might be encountered in areas without evident artery wall thickening, being typically perceived as artefacts., Aims: We aimed to evaluate the utility of NIRS to identify artery wall regions associated with an increase in wall thickness (WT) as assessed by serial intravascular ultrasound (IVUS) and optical coherence tomography (OCT)., Methods: In this prospective, single-centre study, patients presenting with acute coronary syndrome (ACS) underwent NIRS-IVUS and OCT assessment of a non-culprit artery at baseline and 12-month follow-up. For each vessel, 1.5 mm segments were identified, matched and divided into 45 sectors. The relationship between the change in IVUS-based WT (DWT) and the presence of NIRS-positive signals and OCT-detected lipid was evaluated using linear mixed models., Results: A total of 37 patients (38 vessels, 6,936 matched sectors) were analysed at baseline and 12 months. A total of 140/406 (34.5%) NIRS (+) sectors and 513/1,575 (32.6%) OCT-lipid (+) sectors were found to be located in thin (WT<0.5 mm) wall sectors. In the thin wall sectors, an increase in WT was significantly more pronounced in NIRS (+) vs NIRS (-) sectors (0.11 mm vs 0.06 mm, p<0.001). In the thick wall sectors, there was a decrease in WT observed that was less pronounced in the NIRS (+) versus NIRS (-) sectors (-0.08 mm vs -0.09 mm, p<0.001). Thin wall NIRS (+) OCT-lipid (+) sectors showed significant wall thickening (DWT=0.13 mm)., Conclusions: NIRS-positive signals in otherwise non-diseased arterial walls as assessed by IVUS could identify vessel wall regions prone to WT increase over 12-month follow-up. Our observations suggest that NIRS-positive signals in areas without evident wall thickening by IVUS should no longer be viewed as benign or imaging artefact.

Purpose of Review: Three-dimensional quantitative coronary angiography-based methods of fractional flow reserve (FFR) derivation have emerged as an appealing alternative to conventional pressure-wire-based physiological lesion assessment and have the potential to further extend the use of physiology in general. Here, we summarize the current evidence related to angiography-based FFR and perspectives on future developments., Recent Findings: Growing evidence suggests good diagnostic performance of angiography-based FFR measurements, both in chronic and acute coronary syndromes, as well as in specific lesion subsets, such as long and calcified lesions, left main coronary stenosis, and bifurcations. More recently, promising results on the superiority of angiography-based FFR as compared to angiography-guided PCI have been published. Currently available angiography -FFR indices proved to be an excellent alternative to invasive pressure wire-based FFR. Dedicated prospective outcome data comparing these indices to routine guideline recommended PCI including the use of FFR are eagerly awaited., (© 2022. The Author(s).)

Purpose: To assess the variability of renal artery (RA) anatomy and presence of RA-pathology in patients with mild-to-moderate hypertension enrolled in the RADIANCE-HTN SOLO trial., Background: RADIANCE-HTN SOLO was a multicenter, international, blinded, randomized, sham-controlled trial evaluating ultrasound-based endovascular renal denervation (RDN) in patients with mild-to-moderate hypertension while off antihypertensive medications., Methods: Eligible subjects had pre-randomization renal CT- or MR- angiography (CTA, MRA) to confirm anatomic suitability and to define RA ablation sites. All images were sent for independent review for evaluation of RA anatomy and other vascular pathology., Results: A total of 324 patients underwent RA imaging (282 CTA and 42 MRA). Of those, 178 had simple anatomy with a single left and single right RA with mean diameters of 5.4 ± 0.9 and 5.1 ± 0.8 mm and mean lengths of 40.0 ± 12.9 and 52.0 ± 13.1 mm, respectively. Twenty-seven patients (8.3%) had unilateral or bilateral dual RAs with mean diameters of 4.0 ± 0.9 mm on the left and 3.9 ± 0.9 mm on the right. Forty percent (129/324) of patients had at least 1 accessory RA, with mean accessory diameters of 2.4 ± 0.8 mm on the left and 2.3 ± 0.8 mm on the right. Twenty-eight patients (8.6%) had at least 1 short (<25 mm) main RA. Incidental findings included: 9 patients (2.8%) with atherosclerotic RA stenosis ≥30%, 9 patients (2.8%) with fibromuscular dysplasia of RA and 2 patients (0.6%) with kidney and adrenal gland tumors., Conclusions: Pre-procedure CTA or MRA imaging is a valuable aid in assessing RA anatomy prior to RDN because of variable RA anatomy. CTA or MRA may detect RA lesions, and renal or adrenal tumors which may need additional workup prior to consideration of RDN., Clinical Trial Registration: ClinicalTrials.gov NCT02649426., Competing Interests: Declaration of competing interest Dr. Sanghvi has received grant support and personal fees from ReCor Medical and Medtronic; and has received grant support from CSI. Dr. Wang declarations of interest: none. Dr. Daemen has received grant support from ReCor Medical, Medtronic, Boston Scientific, Abbott Vascular, Acist Medical, AstraZeneca, Pie Medical, and Pulse Cath; and has received personal fees from ReCor Medical, Medtronic, Acist Medical, Boston Scientific, Pie Medical, Siemens and Pulse Cath. Dr. Mathur declarations of interest: none. Dr. Jain declarations of interest: none. Dr. Dohad declarations of interest: none. Dr. Sapoval declarations of interest: none. Dr. Azizi has received research grants from the French Ministry of Health, Quantum Genomics, and the European Horizon 2020 program; has received grant support and nonfinancial support from ReCor Medical and Idorsia; and has received personal fees from CVRx, Astra Zeneca, Alnylam Pharmaceutical, and Poxel Pharma. Dr. Mahfoud is supported by Deutsche Gesellschaft für Kardiologie, and Deutsche Forschungsgemeinschaft (SFB TRR 219); and has received grant support and personal fees from ReCor Medical, Medtronic, Berlin Chemie, Bayer, and Boehringer Ingelheim. Dr. Lurz has received grant support and personal fees from ReCor Medical, Edwards, and Abbott and personal fees from Medtronic and Occlutech. Dr. Sayer declarations of interest: none. Dr. Levy declarations of interest: none. Dr. Zagoria has received consulting fees from ReCor Medical. Dr. Loening has received consulting fees from ReCor Medical and grant funding from GE Healthcare and NIH. Dr. Coleman is an employee of ReCor Medical. Mr. Craig is an employee of ReCor Medical. Mrs. Horesh-Bar is an employee of ReCor Medical. Dr. Kirtane reports Institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical. In addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for speaking engagements and/or consulting. Personal: Consulting: Neurotronic; Travel Expenses/Meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Importance: Coronary plaques that are prone to rupture and cause adverse cardiac events are characterized by large plaque burden, large lipid content, and thin fibrous caps. Statins can halt the progression of coronary atherosclerosis; however, the effect of the proprotein convertase subtilisin kexin type 9 inhibitor alirocumab added to statin therapy on plaque burden and composition remains largely unknown., Objective: To determine the effects of alirocumab on coronary atherosclerosis using serial multimodality intracoronary imaging in patients with acute myocardial infarction., Design, Setting, and Participants: The PACMAN-AMI double-blind, placebo-controlled, randomized clinical trial (enrollment: May 9, 2017, through October 7, 2020; final follow-up: October 13, 2021) enrolled 300 patients undergoing percutaneous coronary intervention for acute myocardial infarction at 9 academic European hospitals., Interventions: Patients were randomized to receive biweekly subcutaneous alirocumab (150 mg; n = 148) or placebo (n = 152), initiated less than 24 hours after urgent percutaneous coronary intervention of the culprit lesion, for 52 weeks in addition to high-intensity statin therapy (rosuvastatin, 20 mg)., Main Outcomes and Measures: Intravascular ultrasonography (IVUS), near-infrared spectroscopy, and optical coherence tomography were serially performed in the 2 non-infarct-related coronary arteries at baseline and after 52 weeks. The primary efficacy end point was the change in IVUS-derived percent atheroma volume from baseline to week 52. Two powered secondary end points were changes in near-infrared spectroscopy-derived maximum lipid core burden index within 4 mm (higher values indicating greater lipid content) and optical coherence tomography-derived minimal fibrous cap thickness (smaller values indicating thin-capped, vulnerable plaques) from baseline to week 52., Results: Among 300 randomized patients (mean [SD] age, 58.5 [9.7] years; 56 [18.7%] women; mean [SD] low-density lipoprotein cholesterol level, 152.4 [33.8] mg/dL), 265 (88.3%) underwent serial IVUS imaging in 537 arteries. At 52 weeks, mean change in percent atheroma volume was -2.13% with alirocumab vs -0.92% with placebo (difference, -1.21% [95% CI, -1.78% to -0.65%], P < .001). Mean change in maximum lipid core burden index within 4 mm was -79.42 with alirocumab vs -37.60 with placebo (difference, -41.24 [95% CI, -70.71 to -11.77]; P = .006). Mean change in minimal fibrous cap thickness was 62.67 μm with alirocumab vs 33.19 μm with placebo (difference, 29.65 μm [95% CI, 11.75-47.55]; P = .001). Adverse events occurred in 70.7% of patients treated with alirocumab vs 72.8% of patients receiving placebo., Conclusions and Relevance: Among patients with acute myocardial infarction, the addition of subcutaneous biweekly alirocumab, compared with placebo, to high-intensity statin therapy resulted in significantly greater coronary plaque regression in non-infarct-related arteries after 52 weeks. Further research is needed to understand whether alirocumab improves clinical outcomes in this population., Trial Registration: ClinicalTrials.gov Identifier: NCT03067844.

Background: Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) is superior to angiography-guided PCI. The clinical uptake of FFR has been limited, however, by the need to advance a wire in the coronary artery, the additional time required and the need for hyperaemic agents which can cause patient discomfort. FFR derived from routine coronary angiography eliminates these issues., Aims: The aim of this study was to assess the diagnostic performance and accuracy of three-dimensional quantitative coronary angiography (3D-QCA)-based vessel FFR (vFFR) compared to pressure wire-based FFR (≤0.80)., Methods: The FAST II (Fast Assessment of STenosis severity) study was a prospective observational multicentre study designed to evaluate the diagnostic accuracy of vFFR compared to the reference standard (pressure wire-based FFR ≤0.80). A total of 334 patients from six centres were enrolled. Both site-determined and blinded independent core lab vFFR measurements were compared to FFR., Results: The core lab vFFR was 0.83±0.09 and pressure wire-based FFR 0.83±0.08. A good correlation was found between core lab vFFR and pressure wire-based FFR (R=0.74; p<0.001; mean bias 0.0029±0.0642). vFFR had an excellent diagnostic accuracy in identifying lesions with an invasive wire-based FFR ≤0.80 (area under the curve [AUC] 0.93; 95% confidence interval [CI]: 0.90-0.96; p<0.001). Positive predictive value, negative predictive value, diagnostic accuracy, sensitivity and specificity of vFFR were 90%, 90%, 90%, 81% and 95%, respectively., Conclusions: 3D-QCA-based vFFR has excellent diagnostic performance to detect FFR ≤0.80. The study was registered on clinicaltrials.gov under identifier NCT03791320.

Background: Intravascular ultrasound (IVUS) can overcome the intrinsic limitations of coronary angiography for lesion assessment and stenting. IVUS improves outcomes of patients presenting with stable or complex coronary artery disease, but dedicated data on the impact of IVUS-guided percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI) remains scarce., Methods: We systematically searched Embase, MEDLINE, Web of Science Core Collection, Cochrane Central Register of Controlled Trials and Google Scholar for studies that compared clinical outcomes for IVUS- versus angio-guided PCI in patients with AMI. The primary endpoint was all-cause mortality and the secondary endpoint major adverse cardiovascular events (MACE). Mantel-Haenszel random-effects model was used to calculate pooled risk ratios (RR) with 95% confidence intervals (CI)., Results: Nine studies (8 observational, 1 RCT) with a total of 838.902 patients (796.953 angio-guided PCI, 41.949 IVUS-guided PCI) were included. In patients with AMI, IVUS-guided PCI was associated with a significantly lower risk of all-cause mortality (pooled RR: 0.70; 95% CI, 0.59-0.82; p < 0.01), MACE (pooled RR: 0.86; 95% CI, 0.74-0.99; p = 0.04) and target vessel revascularization (TVR) (pooled RR: 0.83; 95% CI, 0.73-0.95; p < 0.01). In the subset of patients presenting with ST-segment elevation, IVUS-guided PCI remained associated with a reduced risk for both all-cause mortality (pooled RR: 0.79; 95% CI, 0.66-0.95, p = 0.01) and MACE (pooled RR: 0.86; 95% CI, 0.74-0.99, p = 0.04)., Conclusions: This is the first systematic review and meta-analysis comparing IVUS- versus angio-guided PCI in patients with AMI, showing a beneficial effect of IVUS-guided PCI on all-cause mortality, MACE and TVR. Results of ongoing dedicated prospective studies are needed to confirm these findings., (Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.)

Objectives: To evaluate the feasibility of three-vessel three-dimensional (3D) quantitative coronary angiography (QCA)-based fractional flow reserve (FFR) computation in patients discussed within the Heart Team in whom the treatment decision was based on angiography alone, and to evaluate the concordance between 3D QCA-based vessel FFR (vFFR)-confirmed functional lesion significance and revascularisation strategy as proposed by the Heart Team., Design: Retrospective, cohort., Setting: 3D QCA-based FFR indices have not yet been evaluated in the context of Heart Team decision-making; consecutive patients from six institutions were screened for eligibility and three-vessel vFFR was computed by blinded analysts., Participants: Consecutive patients with chronic coronary syndrome or unstable angina referred for Heart Team consultation. Exclusion criteria involved: presentation with acute myocardial infarction (MI), significant valve disease, left ventricle ejection fraction <30%, inadequate quality of angiogram precluding vFFR computation in all three epicardial coronary arteries (ie, absence of a minimum of two angiographic projections with views of at least 30° apart, substantial foreshortening/overlap of the vessel, poor contrast medium injection, ostial lesions, chronic total occlusions)., Primary and Secondary Outcome Measures: Discordance between vFFR-confirmed lesion significance and revascularisation was assessed as the primary outcome measure. Rates of major adverse cardiac events (MACE) defined as cardiac death, MI and clinically driven revascularisation were reported., Results: Of a total of 1003 patients were screened for eligibility, 416 patients (age 65.6±10.6, 71.2% male, 53% stable angina) were included. The most important reason for screening failure was insufficient quality of the angiogram (43%). Discordance between vFFR confirmed lesion significance and revascularisation was found in 124/416 patients (29.8%) corresponding to 149 vessels (46/149 vessels (30.9%) were reclassified as significant and 103/149 vessels (69.1%) as non-significant by vFFR). Over a median of 962 days, the cumulative incidence of MACE was 29.7% versus 18.5% in discordant versus concordant patients (p=0.031)., Conclusions: vFFR computation is feasible in around 40% of the patients referred for Heart Team discussion, a limitation that is mostly based on insufficient quality of the angiogram. Three vessel vFFR screening indicated discordance between vFFR confirmed lesion significance and revascularisation in 29.8% of the patients., Competing Interests: Competing interests: MT acknowledges funding as the laureate of the European Society of Cardiology Research and Training Program in the form of the ESC 2018 Grant. KM received institutional grant support from Acist Medical. LJCvZ received institutional research grant support from Acist Medical. NMVM received research grant support from Edwards, Medtronic, Abbott, Boston Scientific, Pulse Cath, Acist Medical and Essential Medical. JD received institutional grant/research support from Abbott Vascular, Boston Scientific, Acist Medical, Medtronic and PulseCath, and consultancy and speaker fees from Acist medical, Boston Scientific, ReCor Medical, Medtronic and Pulse Cath. The remaining authors have nothing to disclose., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Intravascular ultrasound (IVUS) improves clinical outcome in patients undergoing percutaneous coronary intervention (PCI) but dedicated prospective studies assessing the safety and efficacy of IVUS guidance during primary PCI are lacking., Methods and Analysis: The SPECTRUM study is a prospective investigator-initiated single-centre single-arm observational cohort study aiming to enrol 200 patients presenting with ST-segment elevation myocardial infarct undergoing IVUS-guided primary PCI. IVUS will be performed at baseline, postintervention and postoptimisation (if applicable), using a 40-60 MHz high-definition (HD) system. Baseline tissue characterisation includes the morphological description of culprit lesion plaque characteristics and thrombus as assessed with HD-IVUS. The primary endpoint is target vessel failure at 12 months (defined as a composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularisation). The secondary outcome of interest is IVUS-guided optimisation, defined as IVUS-guided additional balloon dilatation or stent placement. Other endpoints include clinical and procedural outcomes along with post-PCI IVUS findings., Ethics and Dissemination: The protocol of this study was approved by the Ethics Committee of the Erasmus University Medical Center, Rotterdam, the Netherlands. Written informed consent is obtained from all patients. Study findings will be submitted to international peer-reviewed journals in the field of cardiovascular imaging and interventions and will be presented at international scientific meetings., Trial Registration Number: NCT05007535., Competing Interests: Competing interests: JD received institutional grant/research support from Abbott Vascular, ACIST Medical, Astra Zeneca, Boston Scientific, Medtronic, Microport, Pie Medical and ReCor Medical. Nicolas Van Mieghem received institutional research grant support from Abbott Vascular, Abiomed, Boston Scientific, Daiichi-Sankyo, Edward Lifesciences, Medtronic, and PulseCath. Roberto Diletti is consultant to ACIST Medical. JL received speaking fees from Boston Scientific, Philips Volcano, ACIST Medical, Abbott Vascular and Pie Medical., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Hypertension is a modifiable risk factor in patients at the highest risk for cardiovascular events. New invasive treatment options are becoming available that might be particularly appealing for high-risk patients. Therefore, the aim of this study was to determine the prevalence of high-risk patients on routine therapy that do not meet guideline recommended ambulatory blood pressure (ABP) targets., Methods: This single-center, cross-sectional study was conducted at the Erasmus University Medical Center (Rotterdam, The Netherlands). Inclusion criteria were: (1) age 18-80 years, (2) drugs prescribed for hypertension or history of hypertension and (3) high cardiovascular risk as defined according to the European Society of Cardiology/European Society of Hypertension (ESC/ESH) guidelines. Patients underwent standardized office blood pressure (OBP) and same-day 24-h ABP measurements. Blood pressure (BP) control was defined according to the 2018 ESC/ESH and 2017 American College of Cardiology/American Heart Association (ACC/AHA) guidelines., Results: A total of 100 patients were enrolled (median age 71 years, 35% female). Mean OBP was 142.2/81.9 ± 18.6/12.6 mmHg and mean 24-h ABP was 126.1/70.1 ± 14.3/9.2 mmHg. Patients were on 2.0 [25th-75th percentile: 1.0-3.3] Defined Daily Doses of antihypertensive drugs. ESC/ESH guideline 24-h ABP and OBP targets were not met in 41.8% (95%CI: 31.5-52.6%) and 52.7% (95%CI: 42.0-63.3%), respectively. ACC/AHA guideline 24-h ABP and OBP targets were not met in 59.3% (95%CI: 48.5-69.5%) and 79.1% (95%CI: 69.3-86.9%), respectively., Conclusions: BP remains uncontrolled in 40-60% of high-risk hypertensive patients despite routine use of guideline-recommended therapy. Our findings support the search towards novel invasive BP lowering treatment options., (Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.)

The clinical implications of hypertension in addition to a high prevalence of both uncontrolled blood pressure and medication nonadherence promote interest in developing device-based approaches to hypertension treatment. The expansion of device-based therapies and ongoing clinical trials underscores the need for consistency in trial design, conduct, and definitions of clinical study elements to permit trial comparability and data poolability. Standardizing methods of blood pressure assessment, effectiveness measures beyond blood pressure alone, and safety outcomes are paramount. The Hypertension Academic Research Consortium (HARC) document represents an integration of evolving evidence and consensus opinion among leading experts in cardiovascular medicine and hypertension research with regulatory perspectives on clinical trial design and methodology. The HARC document integrates the collective information among device-based therapies for hypertension to better address existing challenges and identify unmet needs for technologies proposed to treat the world's leading cause of death and disability. Consistent with the Academic Research Consortium charter, this document proposes pragmatic consensus clinical design principles and outcomes definitions for studies aimed at evaluating device-based hypertension therapies.

Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

3D coronary angiography-based vessel fractional flow reserve (vFFR) proved to be an accurate diagnostic alternative to invasively measured pressure wire based fractional flow reserve (FFR). The ability to compute post-PCI vFFR using pre-PCI vFFR virtual stent analysis is unknown. We aimed to assess the feasibility and diagnostic accuracy of pre-PCI vFFR virtual stenting analysis (residual vFFR) with post-PCI FFR as a reference. This is an observational, single-center retrospective cohort study including consecutive patients from the FFR-SEARCH registry. We blindly calculated residual vFFR from pre-PCI angiograms and compared them to invasive pressure-wire based post-PCI FFR. Inclusion criteria involved presentation with either stable or unstable angina or non-ST elevation myocardial infarction (NSTEMI), ≥1 significant stenosis in one of the epicardial coronary arteries (percentage diameter stenosis of >70% by QCA or hemodynamically relevant stenosis with FFR ≤0.80) and pre procedural angiograms eligible for vFFR analysis. Exclusion criteria comprised patients with ST elevation myocardial infarction (STEMI), coronary bypass grafts, cardiogenic shock or severe hemodynamic instability. Eighty-one pre-PCI residual vFFR measurements were compared to post-PCI FFR and post-PCI vFFR measurements. Mean residual vFFR was 0.91 ± 0.06, mean post-PCI FFR 0.91 ± 0.06 and mean post-PCI vFFR was 0.92 ± 0.05. Residual vFFR showed a high linear correlation (r = 0.84) and good agreement (mean difference (95% confidence interval): 0.005 (−0.002−0.012)) with post-PCI FFR, as well as with post-PCI-vFFR (r = 0.77, mean difference −0.007 (−0.015−0.0003)). Residual vFFR showed good accuracy in the identification of lesions with post-PCI FFR < 0.90 (sensitivity 94%, specificity 71%, area under the curve (AUC) 0.93 (95% CI: 0.86−0.99), p < 0.001). Virtual stenting using vFFR provided an accurate estimation of post-PCI FFR and post-PCI vFFR. Further studies are needed to prospectively validate a vFFR-guided PCI strategy.

Objective: To compare early clinical outcomes after transcatheter aortic valve implantation (TAVI) with three consecutive generations of self-expanding valves (SEVs)., Methods: Clinical endpoints of consecutive patients who underwent TAVI with CoreValve, Evolut R or Evolut PRO were included in a prospective database., Results: TAVI was performed with CoreValve (n = 116), Evolut R (n = 160) or Evolut PRO (n = 92). Evolut R and Evolut PRO showed a tendency towards lower permanent pacemaker implantation (PPI) rates compared to CoreValve (CoreValve 27% vs Evolut R 16% vs Evolut PRO 18%, p = 0.091). By multivariable regression analysis CoreValve had a significantly higher risk for PPI (odds ratio (OR) 2.79, 95% confidence interval (CI) 1.31-5.94, p = 0.008) compared to Evolut R, while Evolut R and PRO were similar. Severe paravalvular leakage (PVL) occurred only with CoreValve, but no significant difference was observed in moderate PVL (10% vs 8% vs 6%, p = 0.49). CoreValve had a tendency towards a higher risk for more-than-mild PVL as compared with the Evolut platform (R + PRO) (OR 2.46, 95% CI 0.98-6.16, p = 0.055). No significant differences in all-cause mortality (7% vs 4% vs 1%, p = 0.10), stroke (6% vs 3% vs 2%, p = 0.21) or major vascular complications (10% vs 12% vs 4%, p = 0.14) were observed., Conclusions: TAVI with self-expanding valves was safe, and device iterations may result in a lower need for PPI. More-than-mild PVL seemed to occur less often with repositionable technology., (© 2021. The Author(s).)

Objectives: To study the safety and feasibility of a restrictive temporary-RV-pacemaker use and to evaluate the need for temporary pacemaker insertion for failed left ventricular (LV) pacing ability (no ventricular capture) or occurrence of high-degree AV-blocks mandating continuous pacing., Background: Ventricular pacing remains an essential part of contemporary transcatheter aortic valve implantation (TAVI). A temporary-right-ventricle (RV)-pacemaker lead is the standard approach for transient pacing during TAVI but requires central venous access., Methods: An observational registry including 672 patients who underwent TAVI between June 2018 and December 2020. Patients received pacing on the wire when necessary, unless there was a high-anticipated risk for conduction disturbances post-TAVI, based on the baseline-ECG. The follow-up period was 30 days., Results: A temporary-RV-pacemaker lead (RVP-cohort) was inserted in 45 patients, pacing on the wire (LVP-cohort) in 488 patients, and no pacing (NoP-cohort) in 139 patients. A bailout temporary pacemaker was implanted in 14 patients (10.1%) in the NoP-cohort and in 24 patients (4.9%) in the LVP-cohort. One patient in the LVP-cohort needed an RV-pacemaker for incomplete ventricular capture. Procedure time was significantly longer in the RVP-cohort (68 min [IQR 52-88.] vs. 55 min [IQR 44-72] in NoP-cohort and 55 min [IQR 43-71] in the LVP-cohort [p < 0.005]). Procedural high-degree AV-block occurred most often in the RVP-cohort (45% vs. 14% in the LVP and 16% in the NoP-cohort [p ≤ 0.001]). Need for new PPI occurred in 47% in the RVP-cohort, versus 20% in the NoP-cohort and 11% in the LVP-cohort (p ≤ 0.001)., Conclusion: A restricted RV-pacemaker strategy is safe and shortens procedure time. The majority of TAVI-procedures do not require a temporary-RV-pacemaker., (© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Introduction: The aim of the present study was to assess the safety and efficacy of renal sympathetic denervation (RDN) in patients with heart failure with reduced ejection fraction (HFrEF)., Methods: We randomly assigned 50 patients with a left ventricular ejection fraction (LVEF) ≤ 35% and NYHA class ≥ II, in a 1:1 ratio, to either RDN and optimal medical therapy (OMT) or OMT alone. The primary safety endpoint was the occurrence of a combined endpoint of cardiovascular death, rehospitalisation for heart failure, and acute kidney injury at 6 months. The primary efficacy endpoint was the change in iodine-123 meta-iodobenzylguanidine ( 123 I‑MIBG) heart-to-mediastinum ratio (HMR) at 6 months., Results: Mean age was 60 ± 9 years, 86% was male and mean LVEF was 33 ± 8%. At 6 months, the primary safety endpoint occurred in 8.3% vs 8.0% in the RDN and OMT groups, respectively (p = 0.97). At 6 months, the mean change in late HMR was -0.02 (95% CI: -0.08 to 0.12) in the RDN group, versus -0.02 (95% CI: -0.09 to 0.12) in the OMT group (p = 0.95) whereas the mean change in washout rate was 2.34 (95% CI: -6.35 to 1.67) in the RDN group versus -2.59 (95% CI: -1.61 to 6.79) in the OMT group (p-value 0.09)., Conclusion: RDN with the Vessix system in patients with HFrEF was safe, but did not result in significant changes in cardiac sympathetic nerve activity at 6 months as measured using 123 I‑MIBG., (© 2021. The Author(s).)

Background Controversy exists over whether sex has significant interaction with revascularization strategy for unprotected left main coronary artery disease. Higher mortality has been reported among women treated with percutaneous coronary intervention compared with coronary artery bypass grafting. Methods and Results The DELTA (Drug-Eluting Stents for Left Main Coronary Artery Disease) and DELTA-2 registries are international, multicentric registries evaluating the outcomes of subjects undergoing coronary revascularization for unprotected left main coronary artery disease. The primary outcome was a composite of death, myocardial infarction, or cerebrovascular accidents. The population consisted of 6253 patients, including 1689 (27%) women. Women were older and more likely to have diabetes and chronic kidney disease than men ( P <0.05). At a median follow-up of 29 months (interquartile range 12-49), a significant interaction between sex and revascularization strategy was observed for the primary end point (p int =0.012) and all-cause death (p int =0.037). Among women, compared with percutaneous coronary intervention, coronary artery bypass grafting was associated with lower risk of the primary end point (event rate 9.5% versus 15.3%; adjusted hazard ratio [AHR], 0.53; 95% CI, 0.35-0.79, P <0.001) and all-cause death (event rate 5.6% versus 11.7% AHR, 0.50; 95% CI, 0.30-0.82) and no significant differences were observed in men. Conclusions In women undergoing coronary revascularization for unprotected left main coronary artery disease, coronary artery bypass grafting was associated with lower risk of death, myocardial infarction, or cerebrovascular accidents whereas no significant differences between coronary artery bypass grafting and percutaneous coronary intervention were observed in men. Further dedicated studies are needed to determine the optimal revascularization strategy in women with unprotected left main coronary artery disease.

Background: Acute kidney injury (AKI) is a frequent complication in cardiac arrest survivors and associated with adverse outcome. It remains unclear whether the incidence of AKI increases after the post-cardiac arrest contrast administration for coronary angiography and whether this depends on timing of angiography. Aim of this study was to investigate whether early angiography is associated with increased development of AKI compared to deferred angiography in out-of-hospital cardiac arrest (OHCA) survivors., Methods: In this retrospective multicenter cohort study, we investigated whether early angiography (within 2 h) after OHCA was non-inferior to deferred angiography regarding the development of AKI. We used an absolute difference of 5% as the non-inferiority margin. Primary non-inferiority analysis was done by calculating the risk difference with its 90% confidence interval (CI) using a generalized linear model for a binary outcome. As a sensitivity analysis, we repeated the primary analysis using propensity score matching. A multivariable model was built to identify predictors of acute kidney injury., Results: A total of 2375 patients were included from 2009 until 2018, of which 1148 patients were treated with early coronary angiography and 1227 patients with delayed or no angiography. In the early angiography group 18.5% of patients developed AKI after OHCA and 24.1% in the deferred angiography group. Risk difference was - 3.7% with 90% CI ranging from - 6.7 to - 0.7%, indicating non-inferiority of early angiography. The sensitivity analysis using propensity score matching showed accordant results, but no longer non-inferiority of early angiography. The factors time to return of spontaneous circulation (odds ratio [OR] 1.12, 95% CI 1.06-1.19, p < 0.001), the (not) use of angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker (OR 0.20, 95% CI 0.04-0.91, p = 0.04) and baseline creatinine (OR 1.05, 95% CI 1.03-1.07, p < 0.001) were found to be independently associated with the development of AKI., Conclusions: Although AKI occurred in approximately 20% of OHCA patients, we found that early angiography was not associated with a higher AKI incidence than a deferred angiography strategy. The present results implicate that it is safe to perform early coronary angiography with respect to the risk of developing AKI after OHCA., (© 2022. The Author(s).)

Background/purpose: Identification of the culprit lesion in patients with non-ST elevation acute coronary syndrome (NSTE-ACS) allows appropriate coronary revascularization but may be unclear in patients with multivessel coronary disease (MVD). Therefore, we investigated the rate of culprit lesion identification during coronary angiography in NSTE-ACS and multivessel disease., Methods/materials: Consecutive patients presenting with NSTE-ACS and MVD, between January 2012 and December 2016 were evaluated. Coronary angiograms, intravascular imaging, and ECGs were analyzed for culprit lesion identification. Long-term clinical outcomes in terms of major adverse cardiac events (MACE) and mortality were reported in patients with or without culprit identification., Results: A total of 1107 patients with NSTE-ACS and MVD were included in the analysis, 310 (28.0%) with unstable angina and 797 (72.0%) with non-ST elevation myocardial infarction. The culprit lesion was angiographically identified in 952 (86.0%) patients, while no clear culprit lesion was found in 155 (14.0%) patients. ECG analysis allowed to predict the location of the culprit vessel with low sensitivity (range 28.4%-36.7%) and high specificity (range 90.6%-96.5%). Higher lesion complexity was associated with inability to identify the culprit. Intravascular imaging was applied in 55 patients and helped to identify the culprit lesion in 53 patients (96.4%). There was no difference in all-cause mortality (21.4% vs. 25.8%, p = 0.24) and MACE (39.2% vs. 47.6%, p = 0.07) between the cohorts with or without culprit lesion identification by angiography., Conclusions: The culprit lesion appeared unclear by coronary angiography in >10% of patients with NSTE-ACS and MVD. Complementary invasive imaging substantially enhanced the diagnostic accuracy of culprit lesion detection., Competing Interests: Declaration of competing interest None., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: The RADIANCE-HTN SOLO trial demonstrated a greater reduction in daytime ambulatory SBP at 2 months by endovascular ultrasound renal denervation than sham procedure. We hypothesized that plasma renin and aldosterone concentrations would be associated with the SBP response to renal denervation., Methods: Hypertensive patients were randomized to renal denervation (n = 74) or sham (n = 72) after a 4-week washout of antihypertensive medications. In a 53-patient subset, 2-month and 6-month plasma renin and aldosterone concentration were measured. Dietary sodium was not controlled., Results: Mean age of the 29 treatment and 24 sham patients was 54 years; 62% were men; 17% black. Daytime ambulatory SBP fell in the denervation but not the sham group at 2 months (-7.8 ± 10.7 vs. -0.1 ± 10.1 mmHg; P = 0.048). Baseline plasma renin and aldosterone concentrations were in the low-normal range, did not change significantly at 2 months in either group and did not predict response to renal denervation. At 6 months, after the addition of antihypertensive medications, there was a significant rise in renin in the sham but not the denervation group., Conclusion: Although renal denervation but not sham resulted in a decrease in daytime ambulatory SBP at 2 months, renin and aldosterone concentrations did neither predict the BP response to renal denervation; nor did they fall after denervation. A rise in renin at 6 months in the sham group likely represents confounding from antihypertensive medications. Whether the BP-lowering effect of renal denervation depends on reducing local intrarenal renin release requires further study., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Introduction: We aimed to compare conduction dynamics and need for permanent pacemaker implantation (PPI) after CoreValve, Evolut R and PRO (transcatheter aortic valve replacement (TAVR))., Methods: Patients were stratified based on conduction at baseline; Cohort A had normal conduction, Cohort B had conduction abnormalities including atrioventricular (AV)-block, fascicular block or complete bundle branch block. Three different dynamic QRS-patterns were defined: stable QRS-duration, transient QRS-prolongation and persistent QRS-prolongation. We performed multivariable regression analysis to estimate the effect of the three separate transcatheter heart valves (THV's) on need for PPI at 30 days., Results: TAVR was performed with CoreValve (N = 113), Evolut R (N = 157) or Evolut PRO (N = 92). Conduction dynamics were similar between the different THVs. Overall, Evolut R and PRO showed a tendency towards less PPI compared to CoreValve (17% vs. 19% vs. 27%, P = 0.08), which was driven by a lower PPI rate in Cohort A (6% vs. 11% vs. 25%, P = 0.002). Need for PPI was restricted to patients with persistent QRS-prolongation in Cohort A (26/106) but did not correlate with conduction dynamics in Cohort B. In multivariable logistic regression analysis the use of Evolut R (OR 0.38, 95% CI 0.19-0.78, P = 0.008) and PRO (OR 0.41, 95% CI 0.19-0.91, P-value = 0.028) were independently associated with less need for PPI., Conclusion: The newer generations Evolut R and PRO were associated with less PPI compared to CoreValve. Acquired persistent conduction abnormalities predicted PPI after TAVR only in patients with normal conduction at baseline. Our findings may help identify eligible patients for early discharge after Evolut R/PRO TAVR., Competing Interests: Declaration of competing interest HK:no conflicts of interest to declare. LVG:no conflicts of interest to declare. MVW:no conflicts of interest to declare. JO:no conflicts of interest to declare. FZ:no conflicts of interest to declare. ZR:no conflicts of interest to declare. NEF:no conflicts of interest to declare. AM:no conflicts of interest to declare. IK:no conflicts of interest to declare. JD:no conflicts of interest to declare. PDJ:is proctor for Boston Scientific. NVMhas received research grants from Medtronic, Boston scientific, Edwards Lifesciences, Abbott, PulseCath. He is advisor to PulseCath, Ancora, Boston Scientific, Medtronic., (Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objectives: To compare stent recoil (SR) of the thin-strut durable-polymer Zotarolimus-eluting stent (dp-ZES) and the ultrathin-strut bioabsorbable-polymer Sirolimus-eluting stent (bp-SES) in chronic total occlusions (CTOs) and to investigate the predictors of high SR in CTOs., Background: Newer ultrathin drug eluting stent might be associated with lower radial force and higher elastic recoil due to the thinner strut design, possibly impacting on the rate of in-stent restenosis and thrombosis., Methods: Between January 2017 and November 2019, consecutive patients with CTOs undergoing percutaneous coronary intervention were evaluated. Only patients treated with dp-ZES or bp-SES were included and stratified accordingly. Quantitative coronary angiography analysis was used to assess absolute SR, relative SR, absolute focal SR, relative focal SR, high absolute, and high relative focal SR., Results: A total of 128 lesions (67 treated with dp-ZES and 61 with bp-SES) in 123 patients were analyzed. Between bp-SES and dp-ZES no differences were found in absolute SR (p = .188), relative SR (p = .138), absolute focal SR (p = .069), and relative focal SR (p = .064). High absolute and high relative focal SR occurred more frequently in bp-SES than in dp-ZES (p = .004 and p = .015). Bp-SES was a predictor of high absolute focal SR (Odds ratio [OR] 3.29, 95% confidence interval [CI] 1.50-7.22, p = .003]. High-pressure postdilation and bp-SES were predictors of high relative focal SR (OR 2.22, 95% CI 1.01-4.86, p = .047; OR 2.74, 95% CI 1.24-6.02, p = .012, respectively)., Conclusions: Both stents showed an overall low SR. However, ultra-thin strut bp-SES was a predictor of high absolute and high relative focal SR., (© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: Functional mitral regurgitation (FMR) can be subclassified on the basis of its proportionality relative to left ventricular (LV) volume and function, indicating potential differences in underlying etiology. The aim of this study was to evaluate the association of FMR proportionality with FMR reduction, heart failure hospitalization and mortality after transcatheter edge-to-edge mitral valve repair (TEER)., Methods: This multicenter registry included 241 patients with symptomatic heart failure with reduced LV ejection fraction treated with TEER for moderate to severe or greater FMR. FMR proportionality was graded on preprocedural transthoracic echocardiography using the ratio of the effective regurgitant orifice area to LV end-diastolic volume. Baseline characteristics, follow-up transthoracic echocardiography, and 2-year clinical outcomes were compared between groups., Results: Median LV ejection fraction, effective regurgitant orifice area and LV end-diastolic volume index were 30% (interquartile range [IQR], 25%-35%), 27 mm 2 , and 107 mL/m 2 (IQR, 90-135 mL/m 2 ), respectively. Median effective regurgitant orifice area/LV end-diastolic volume ratio was 0.13 (IQR, 0.10-0.18). Proportionate FMR (pFMR) and disproportionate FMR (dFMR) was present in 123 and 118 patients, respectively. Compared with patients with pFMR, those with dFMR had higher baseline LV ejection fractions (median, 32% [IQR, 27%-39%] vs 26% [IQR, 22%-33%]; P < .01). Early FMR reduction with TEER was more pronounced in patients with dFMR (odds ratio, 0.45; 95% CI, 0.28-0.74; P < .01) than those with pFMR, but not at 12 months (odds ratio, 0.93; 95% CI, 0.53-1.63; P = .80). Overall, in 35% of patients with initial FMR reduction after TEER, FMR deteriorated again at 1-year follow-up. Rates of 2-year all-cause mortality and heart failure hospitalization were 30% (n = 66) and 37% (n = 76), with no differences between dFMR and pFMR., Conclusions: TEER resulted in more pronounced early FMR reduction in patients with dFMR compared with those with pFMR. Yet after initial improvement, FMR deteriorated in a substantial number of patients, calling into question durable mitral regurgitation reductions with TEER in selected patients. The proportionality framework may not identify durable TEER responders., (Copyright © 2021 American Society of Echocardiography. Published by Elsevier Inc. All rights reserved.)

Background/purpose: The MANTA is a dedicated plug-based large-bore vascular closure device (VCD) providing safe hemostasis in most patients, but data on the clinical impact and mechanisms of MANTA related complications are limited. This study sought to determine the frequency, impact and predictors of MANTA-related access complications., Methods/materials: This patient-level meta-analysis included data from 2 medical device approval studies and 1 post-approval registry. The primary endpoint was the composite of major and minor access complications. Technical success was defined as hemostasis with MANTA closure device without need for vascular surgery or stenting., Results: Eight hundred ninety-one patients (mean age 80) underwent transcatheter aortic valve replacement (n = 814), endovascular aortic repair (n = 71), balloon aortic valvuloplasty (n = 4) or mechanical circulatory support (n = 2). Technical success was 96.4% and median time to hemostasis was 31 (interquartile range: 17-76) seconds. The primary endpoint occurred 9.1% and bailout vascular surgery or stenting was necessary in 32 patients (3.6%). Female gender (OR: 2.63, CI: 1.46-4.73, p = 0.001), left femoral access (OR: 2.18, CI: 1.17-4.06, p = 0.015) and unfavorable arteriotomy phenotype (combination of a small femoral artery diameter with a deep arteriotomy; OR 2.27: 1.26-4.10, p = 0.006) independently predicted access complications. Access complications most often consisted of vessel dissection, stenosis or occlusion and predominantly occurred in patients with an unfavorable arteriotomy phenotype., Conclusions: Large-bore arteriotomy closure with MANTA VCD provided fast and safe hemostasis with an acceptable complication rate. Refined procedure planning and risk-stratification may further improve MANTA VCD performance., Competing Interests: Declaration of competing interest Dr. Van Mieghem received research grants from Teleflex. Other authors have nothing to declare., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The multicentre, randomised, sham-controlled RADIANCE-HTN SOLO trial reported the blood pressure (BP)-lowering efficacy and safety of ultrasound renal denervation (RDN) in the absence (2 months) and presence (6 and 12 months) of antihypertensive medications in patients with mild-to-moderate hypertension., Aims: The aim of this report was to evaluate patients originally assigned to the sham group who crossed over to RDN., Methods: After the primary endpoint was met, patients in the sham arm who remained uncontrolled were allowed to cross over to receive RDN. All patients were unblinded and treated with standard of care medications at the time of crossover. Ambulatory BP was evaluated 2 and 6 months after crossover., Results: Among 72 subjects of the sham arm, 33 underwent ultrasound RDN after an average follow-up of 23±6 months. Prior to crossover, patients had a daytime ambulatory BP of 144.1±10.1/89.9±8.4 mmHg and received 1.2±0.8 antihypertensive medications. Mean change in daytime ambulatory BP from pre-crossover to 2 and 6 months post RDN was -11.2±13.7/-7.1±8.9 mmHg (n=33; p<0.001; p<0.001) and -10.8±17.3/-7.8±11.6 mmHg (n=27; p=0.002; p<0.001). The number of antihypertensive medications did not change from pre-crossover baseline to 2 and 6 months. Eighteen of 33 (54.5%) patients had their daytime ambulatory BP controlled (<135/85 mmHg) at 2 months and 44.4% (12/27) at 6 months post RDN. No major procedure-related adverse events occurred., Conclusions: During unblinded long-term follow-up of the RADIANCE-HTN SOLO study, patients originally assigned to a sham procedure who remained uncontrolled had significant reductions in BP following crossover treatment with ultrasound RDN.

Objectives: To report on the experience with a selective prophylactic permanent pacemaker (PPx-PPM) implantation strategy in patients with pre-existing right bundle branch block (RBBB) undergoing transcatheter aortic valve replacement (TAVR)., Background: Pre-existing RBBB is an independent predictor for PPM after TAVR and has been linked to increased mortality., Methods: Hospital patient flow and longer-term clinical endpoints were compared for TAVR patients with pre-existing RBBB treated in a period with and without selective PPx-PPM strategy (2013-2020)., Results: A total of 260 patients were included: 170 in the early period without PPx-PPM strategy and 90 patients in the late period with selective PPx-PPM strategy. A PPx-PPM was implanted in 44% of patients in the late period. Overall, 69% versus 80% of all patients in the early versus late period ended up with a PPM (p = .06). Streamlined transfemoral TAVR was routinely used from 2017-in this series of patients, both TAVR procedural time and hospital length of stay (LoS) were significantly shorter in the late versus early period (mean procedural time: 70 vs. 83 min and LoS ≥5 days: 15% vs. 40%; p < .05). No difference in all-cause/cardiovascular mortality was observed between both strategies, whereas cardiac rehospitalization was significantly higher for patients treated in the early versus late period (hazard ratio 2.33 [1.04-5.26]; p = .042)-this mainly due to (sub)acute PPM-implantation early after discharge., Conclusions: Selective prophylactic PPM implantation in TAVR candidates with pre-existing RBBB results in shorter TAVR procedural time and hospital LoS and prevents early cardiac rehospitalization related to complete heart block., (© 2021 Wiley Periodicals LLC.)

Although clinical outcomes after percutaneous coronary intervention (PCI) are improving, the long-term risk for target vessel failure remains concerning. Although the application of intravascular imaging and physiological indexes significantly improves outcomes, their routine use in practice remains limited. Nevertheless, merely using these modalities is not enough, and to truly improve patient outcomes, optimal intravascular dimensions with minimal vascular injury should be targeted. When assessing post-PCI results using either type of physiological or imaging technology, a broad spectrum of stent- and vessel-related anomalies can be expected. As not all of these issues warrant treatment, a profound knowledge of what to expect and how to recognize and when to treat these intraluminal problems is needed. Additionally, promising new modalities such as angiography-derived coronary physiology and hybrid imaging catheters are becoming available. The authors provide an overview of the currently available tools and techniques to define suboptimal PCI and when to apply these technologies to improve outcomes., Competing Interests: Funding Support and Author Disclosures Dr van Zandvoort has received institutional research support from ACIST Medical, Pie Medical Imaging, and REVA Medical. Dr Ali has received grants from Abbott Vascular and Cardiovascular Systems; personal fees from Amgen, AstraZeneca, and Boston Scientific; and holds equity in Shockwave Medical. Dr Kern has received consulting fees from Abbott, ACIST Medical, Boston Scientific, OpSens Medical, and Philips. Dr Mintz has received honoraria from Boston Scientific, Philips/Volcano, Medtronic, and Abiomed. Dr van Mieghem has received institutional research grants from Abbott, Boston Scientific, Medtronic, PulseCath BV, Abiomed, Daiichi-Sankyo, and Edwards Lifesciences. Dr Daemen has received institutional grant and research support from AstraZeneca, Abbott Vascular, Boston Scientific, ACIST Medical, Medtronic, Pie Medical Imaging, and ReCor Medical., (Copyright © 2021. Published by Elsevier Inc.)

Wall shear stress (WSS), the frictional force of the blood on the vessel wall, plays a crucial role in atherosclerotic plaque development. Low WSS has been associated with plaque growth, however previous research used different approaches to define low WSS to investigate its effect on plaque progression. In this study, we used four methodologies to allocate low, mid and high WSS in one dataset of human coronary arteries and investigated the predictive power of low WSS for plaque progression. Coronary reconstructions were based on multimodality imaging, using intravascular ultrasound and CT-imaging. Vessel-specific flow was measured using Doppler wire and computational fluid dynamics was performed to calculate WSS. The absolute WSS range varied greatly between the coronary arteries. On the population level, the established pattern of most plaque progression at low WSS was apparent in all methodologies defining the WSS categories. However, for the individual patient, when using measured flow to determine WSS, the absolute WSS values range so widely, that the use of absolute thresholds to determine low WSS was not appropriate to identify regions at high risk for plaque progression., (© 2021. The Author(s).)

Background: The MANTA vascular closure device (VCD) is dedicated to large bore access closure and associated with favorable results in selected study populations. Anatomical predictors for access site complications are lacking., Aim: To evaluate MANTA in a real-world population and identify predictors for vascular complications., Methods: All patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) between January 2016 and May 2020 with MANTA closure were included. Baseline characteristics were collected, pre-procedural computed tomography and post-deployment femoral angiograms were analyzed for anatomical differences. The primary endpoint was a composite of access site related major and minor vascular complications at 30 days follow-up according to the VARC-2 definitions. Secondary endpoints included bleeding, time to hemostasis, procedural length and incomplete arteriotomy closure or arterial occlusion by angiography. A Cox proportional hazards model was used to compare all-cause mortality for patients with and without an access site complication., Results: The 512 patients underwent TAVR with MANTA access closure. Median age was 80 (IQR 75-85), 53% was male, median BMI was 26.4 kg/m2 (IQR 23.4-29.7). Access site related major- or minor vascular complication occurred in 20 (4%) and 23 (4%) of patients respectively. Median time to hemostasis was 42 s (IQR 28-98). Post deployment angiogram showed an occlusion in 24 patients (5%), incomplete closure in 60 patients (12%) or both in three patients (1%). Of these 87 patients, 36 (41%) had a vascular complication. Femoral artery diameter (OR 0.70 [0.53-0.93]), low- (OR 3.47 [1.21-10.00]) and high (OR 2.43 [1.16-5.10]) arteriotomies were independent predictors for vascular complications., Conclusion: In this contemporary TAVR population, access-site related complications occurred in 8% of patients and were mainly due to percutaneous closure device failure. Small artery diameter and off-target punctures were independent predictors., (© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Objectives: The impact of large thrombus burden (LTB) on very long-term clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) is unknown. We compared very long-term clinical outcomes in STEMI patients with either LTB or small thrombus burden (STB)., Methods: Between 2002 and 2004, thrombus burden (TB) was evaluated in consecutive patients with STEMI undergoing percutaneous coronary intervention (PCI). In occluded infarct-related arteries, TB was reclassified after flow restoration. LTB was defined as thrombus ≥2 vessel diameters. Major adverse cardiac event (MACE) rate was evaluated at 10-year follow-up and survival data were collected up to 15 years post PCI., Results: A total of 812 patients were enrolled, and TB assessment was available for 806 patients (99.3%); 580 patients (72.0%) had STB and 226 patients (28.0%) had LTB. Patients with LTB experienced more no reflow (4.0% vs 0.5%; P<.01) and distal embolization (17.3% vs 3.4%; P<.001) than STB patients. Ten-year MACE rate (42.5% vs 42.4%; P=.59), 10-year mortality rate (27.0% vs 26.4%; P=.75), and 15-year mortality rate (31.9% vs 35.9%; P=.29) were similar between STB and LTB groups, respectively. By landmark analysis, MACE rate was higher in the LTB group (15.9% vs 8.8%; P<.01) at 30 days, but not beyond (31.6% vs 36.9%; P=.28). There was no difference in mortality at any time point (at 30 days, 9.7% vs 6.2%; P=.08; beyond 30 days, 17.3% vs 20.5%; P=.48). LTB was an independent predictor of MACE at 30 days post PCI (hazard ratio, 1.60; 95% confidence interval, 1.01-2.51; P=.04)., Conclusions: In STEMI patients, LTB might identify a subpopulation at high risk of no-reflow, distal embolization, and early ischemic events, but is not associated with worse clinical outcomes at long-term follow-up.

Background: Coronary calcification has been linked to cardiovascular events. We developed and validated an algorithm to automatically quantify coronary calcifications on intravascular ultrasound (IVUS). We aimed to assess the prognostic value of an IVUS-calcium score (ICS) on patient-oriented composite endpoint (POCE)., Methods: We included patients that underwent coronary angiography plus pre-procedural IVUS imaging. The ICS was calculated per patient. The primary endpoint was a composite of all-cause mortality, stroke, myocardial infarction, and revascularization (POCE)., Results: In a cohort of 408 patients, median ICS was 85. Both an ICS ≥ 85 and a 100 unit increase in ICS increased the risk of POCE at 6-year follow-up (adjusted hazard ratio (aHR) 1.51, 95%CI 1.05-2.17, p value = 0.026, and aHR 1.21, 95%CI 1.04-1.41, p value = 0.014, respectively)., Conclusions: The ICS, calculated by a validated automated algorithm derived from routine IVUS pullbacks, was strongly associated with the long-term risk of POCE., (© 2021. The Author(s).)

Objectives: To validate novel dedicated 3D-QCA based on the software to calculate post PCI vessel-FFR (vFFR) in a consecutive series of patients, to assess the diagnostic accuracy, and to assess inter-observer variability., Background: Low post percutaneous coronary intervention (PCI) fractional flow reserve (FFR) predicts future adverse cardiac events. However, FFR assessment requires the insertion of a pressure wire in combination with the use of a hyperemic agent., Methods: FAST POST study is an observational, retrospective, single-center cohort study. One hundred patients presenting with stable angina or non ST-elevation myocardial infarction, who underwent post PCI FFR assessment using a dedicated microcatheter were included. Two orthogonal angiographic projections were acquired to create a 3D reconstruction of the coronary artery using the CAAS workstation 8.0. vFFR was subsequently calculated using the aortic root pressure., Results: Mean age was 65±12 years and 70% were male. Mean microcatheter based FFR and vFFR were 0.91±0.07 and 0.91±0.06, respectively. A good linear correlation was found between FFR and vFFR (r = 0.88; p <.001). vFFR had a higher accuracy in the identification of patients with FFR values <0.90, AUC 0.98 (95% CI: 0.96-1.00) as compared with 3D-QCA AUC 0.62 (95% CI: 0.94-0.74). Assessment of vFFR had a low inter-observer variability (r = 0.95; p <.001)., Conclusion: 3D-QCA derived post PCI vFFR correlates well with invasively measured microcatheter based FFR and has a high diagnostic accuracy to detect FFR <0.90 with low inter-observer variability., (© 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: Intravascular polarization-sensitive optical frequency domain imaging (PS-OFDI) offers a novel approach to measure tissue birefringence, which is elevated in collagen and smooth muscle cells, that in turn plays a critical role in healing coronary thrombus (HCT). This study aimed to quantitatively assess polarization properties of coronary fresh and organizing thrombus with PS-OFDI in patients with acute coronary syndrome (ACS)., Methods and results: The POLARIS-I prospective registry enrolled 32 patients with ACS. Pre-procedural PS-OFDI pullbacks using conventional imaging catheters revealed 26 thrombus-regions in 21 patients. Thrombus was manually delineated in conventional OFDI cross-sections separated by 0.5 mm and categorized into fresh thrombus caused by plaque rupture, stent thrombosis, or erosion in 18 thrombus-regions (182 frames) or into HCT for 8 thrombus-regions (141 frames). Birefringence of coronary thrombus was compared between the 2 categories. Birefringence in HCTs was significantly higher than in fresh thrombus (∆n=0.47 (0.37-0.72) vs. ∆n=0.25 (0.17-0.29), P=0.007). In a subgroup analysis, when only using thrombus-regions from culprit lesions, ischemic time was a significant predictor for birefringence (ß (∆n)=0.001 per hour, 95% CI [0.0002-0.002], P=0.023)., Conclusions: Intravascular PS-OFDI offers the opportunity to quantitatively assess the polarimetric properties of fresh and organizing coronary thrombus, providing new insights into vascular healing and plaque stability.

Selecting patients with a high chance of endured benefit from transcatheter aortic valve implantation (TAVI) is becoming relevant with changing indications and increasing number of TAVI being performed. The aim of our study was to investigate the association of the multidimensional prognostic index (MPI) based on a comprehensive geriatric assessment (CGA) on survival. The TAVI Care & Cure program is a prospective, observational registry of patients referred for TAVI at the Erasmus MC University Medical Center. Consecutive patients who underwent a complete CGA and TAVI were included. CGA components were used to calculate the MPI score. The impact of the MPI score on survival was evaluated using Cox regression. Furthermore, 376 patients were included, 143 (38.0%) patients belonged to the MPI-1 group and 233 (61.9%) patients to the MPI-2-3 group. After 3 years, 14.9% of the patients in the MPI-1 group and 30.5% of the patients in the MPI-2-3 group died ( p = 0.001). Patients in MPI-1 had increased chances of overall survival in comparison with patients in MPI group 2-3 Hazard Ratio (HR) 0.57, (95% Confidence Interval (CI) 0.33-0.98)). In this study we found that the MPI tool could be useful to assess frailty and to predict which patient will have a higher chance of enduring benefit from a TAVI procedure.

Coronary atherosclerosis is a leading cause of illness and death in Western World and its mechanisms are still non completely understood. Several animal models have been used to 1) study coronary atherosclerosis natural history and 2) propose predictive tools for this disease, that is asymptomatic for a long time, aiming for a direct translation of their findings to human coronary arteries. Among them, swine models are largely used due to the observed anatomical and pathophysiological similarities to humans. However, a direct comparison between swine and human models in terms of coronary hemodynamics, known to influence atherosclerotic onset/development, is still lacking. In this context, we performed a detailed comparative analysis between swine- and human-specific computational hemodynamic models of coronary arteries. The analysis involved several near-wall and intravascular flow descriptors, previously emerged as markers of coronary atherosclerosis initiation/progression, as well as anatomical features. To do that, non-culprit coronary arteries (18 right-RCA, 18 left anterior descending-LAD, 13 left circumflex-LCX coronary artery) from patients presenting with acute coronary syndrome were imaged by intravascular ultrasound and coronary computed tomography angiography. Similarly, the three main coronary arteries of ten adult mini-pigs were also imaged (10 RCA, 10 LAD, 10 LCX). The geometries of the imaged coronary arteries were reconstructed (49 human, 30 swine), and computational fluid dynamic simulations were performed by imposing individualized boundary conditions. Overall, no relevant differences in 1) wall shear stress-based quantities, 2) intravascular hemodynamics (in terms of helical flow features), and 3) anatomical features emerged between human- and swine-specific models. The findings of this study strongly support the use of swine-specific computational models to study and characterize the hemodynamic features linked to coronary atherosclerosis, sustaining the reliability of their translation to human vascular disease., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 De Nisco, Chiastra, Hartman, Hoogendoorn, Daemen, Calò, Gallo, Morbiducci and Wentzel.)

Background: The risk for cardiovascular adverse events after acute myocardial infarction (AMI) remains high despite potent medical treatment including low-density lipoprotein cholesterol (LDL-C) lowering with statins. Proprotein convertase subtilisin/kexin type 9 (PCSK9) antibodies substantially reduce LDL-C when added to statin. Alirocumab, a monoclonal antibody to PCSK9, reduces major adverse cardiovascular events after AMI. The effects of alirocumab on coronary atherosclerosis including plaque burden, plaque composition and fibrous cap thickness in patients presenting with AMI remains unknown., Aims: To determine the effect of LDL-C lowering with alirocumab on top of high-intensity statin therapy on intravascular ultrasound (IVUS)-derived percent atheroma volume (PAV), near-infrared spectroscopy (NIRS)-derived maximum lipid core burden index within 4 mm (maxLCBI 4 mm ) and optical coherence tomography (OCT)-derived fibrous cap thickness (FCT) in patients with AMI., Methods: In this multicenter, double-blind, placebo-controlled trial, 300 patients with AMI (ST-elevation or non-ST-elevation myocardial infarction) were randomly assigned to receive either biweekly subcutaneous alirocumab (150 mg) or placebo beginning <24 hours after the acute event as add-on therapy to rosuvastatin 20 mg. Patients undergo serial IVUS, NIRS and OCT in the two non-infarct related arteries at baseline (at the time of treatment of the culprit lesion) and at 52 weeks. The primary endpoint, change in IVUS-derived PAV, and the powered secondary endpoints, change in NIRS-derived maxLCBI 4 mm , and OCT-derived minimal FCT, will be assessed 52 weeks post randomization., Summary: The PACMAN-AMI trial will determine the effect of alirocumab on top of high-intensity statin therapy on high-risk coronary plaque characteristics as assessed by serial, multimodality intracoronary imaging in patients presenting with AMI., Clinical Trial Registration: NCT03067844., (Copyright © 2021. Published by Elsevier Inc.)

In the context of designing a next-generation ultrasonic polar scan (UPS) measurement system for viscoelastic material characterization, a novel approach is proposed, which draws on a set of cylindrically focused emitters in conjunction with a circular phased array (C-PA) receiver in order to create a portable measurement system while improving the data quality and ease the data interpretation. To explore the potential of the new approach and determine its optimal design parameters, a 3-D analytical model is presented to numerically simulate UPS experiments with the proposed system. Furthermore, a postprocessing procedure is worked out to treat the acquired raw data with the aim to deal with the integrating effect of finite size transducers and directly reconstruct the angle-dependent plane wave reflection coefficients of the sample under study. As the accuracy of the reconstruction heavily depends on various design parameters, a parameter study focusing on the influence of three main experimental parameters is performed to guide the optimal design. For each of these parameter studies, the UPS simulation results have been inverted, and the errors on the estimated C-tensor parameters have been deduced. First, it is shown that, for a given frequency, the radius of the C-PA must be large enough to capture both the specular and nonspecular reflected field, which is crucial to assure a correct reconstruction of the plane wave characteristics and find proper estimates of the C-tensor parameters. Second, the impact of the emitter and receiver lengths on the quality of the reconstruction and the C-tensor parameters has been investigated, yielding superior results upon increasing either of them. Finally, a dedicated study of the pitch of the C-PA elements and the angular range of the cylindrically focused emitters shows that aliasing effects disturb the results if the pitch is too large. However, this effect can somewhat be mitigated by employing multiple emitters with a restricted angular range. Using the knowledge of the abovementioned parameter studies, a simulated UPS experiment using a proper set of design parameters is performed for a cross-ply carbon epoxy laminate. The postprocessed reconstruction based on these data shows an excellent agreement with the theoretical plane wave results.

Background: Functional mitral regurgitation (FMR) can be subclassified based on its proportionality relative to left ventricular function and end-diastolic volume. FMR proportionality could help identify responders to transcatheter edge-to-edge mitral valve repair (MitraClip) in terms of residual FMR and/or clinical improvement., Methods: This single-centre retrospective cohort study evaluated the feasibility of determining FMR proportionality in symptomatic heart failure patients with reduced left ventricular function who were treated with MitraClip for ≥ moderate-to-severe FMR. Baseline proportionate (pFMR) and disproportionate FMR (dFMR) were distinguished. Patient characteristics and MitraClip procedural outcomes were described., Results: From an overall cohort of 81 eligible FMR patients, 23/81 (28%) had to be excluded due to missing transthoracic echocardiogram parameters, 22/81 were excluded based on FMR severity. The remaining cohort, of 36/81 patients (44%), could be classified into dFMR (n = 26) or pFMR (n = 10). Conduction disorders were numerically increased in dFMR. All cases requiring > 2 clips were in the dFMR group and absence of FMR reduction occurred more frequently with dFMR., Point of View/conclusion: Important limitations in terms of imaging acquisition affect the translation of the FMR proportionality concept to a real-world data set. We did observe different demographic and FMR response patterns in patients with proportionate and disproportionate FMR that warrant further investigation., (© 2021. The Author(s).)

Background: Endovascular renal denervation reduces blood pressure in patients with mild-to-moderate hypertension, but its efficacy in patients with true resistant hypertension has not been shown. We aimed to assess the efficacy and safety of endovascular ultrasound renal denervation in patients with hypertension resistant to three or more antihypertensive medications., Methods: In a randomised, international, multicentre, single-blind, sham-controlled trial done at 28 tertiary centres in the USA and 25 in Europe, we included patients aged 18-75 years with office blood pressure of at least 140/90 mm Hg despite three or more antihypertensive medications including a diuretic. Eligible patients were switched to a once daily, fixed-dose, single-pill combination of a calcium channel blocker, an angiotensin receptor blocker, and a thiazide diuretic. After 4 weeks of standardised therapy, patients with daytime ambulatory blood pressure of at least 135/85 mm Hg were randomly assigned (1:1) by computer (stratified by centres) to ultrasound renal denervation or a sham procedure. Patients and outcome assessors were masked to randomisation. Addition of antihypertensive medications was allowed if specified blood pressure thresholds were exceeded. The primary endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Safety was also assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02649426., Findings: Between March 11, 2016, and March 13, 2020, 989 participants were enrolled and 136 were randomly assigned to renal denervation (n=69) or a sham procedure (n=67). Full adherence to the combination medications at 2 months among patients with urine samples was similar in both groups (42 [82%] of 51 in the renal denervation group vs 47 [82%] of 57 in the sham procedure group; p=0·99). Renal denervation reduced daytime ambulatory systolic blood pressure more than the sham procedure (-8·0 mm Hg [IQR -16·4 to 0·0] vs -3·0 mm Hg [-10·3 to 1·8]; median between-group difference -4·5 mm Hg [95% CI -8·5 to -0·3]; adjusted p=0·022); the median between-group difference was -5·8 mm Hg (95% CI -9·7 to -1·6; adjusted p=0·0051) among patients with complete ambulatory blood pressure data. There were no differences in safety outcomes between the two groups., Interpretation: Compared with a sham procedure, ultrasound renal denervation reduced blood pressure at 2 months in patients with hypertension resistant to a standardised triple combination pill. If the blood pressure lowering effect and safety of renal denervation are maintained in the long term, renal denervation might be an alternative to the addition of further antihypertensive medications in patients with resistant hypertension., Funding: ReCor Medical., Competing Interests: Declaration of interests MA has received research grants from the French Ministry of Health, Quantum Genomics, and the European Horizon 2020 programme; has received grant support and non-financial support from ReCor Medical and Idorsia; and has received personal fees from CVRx, AstraZeneca, Alnylam Pharmaceutical, and Poxel Pharma. KS has received grant support and personal fees from ReCor Medical and Medtronic, and has received grant support from Cardiovascular Systems. MSax has received grant support and personal fees from ReCor Medical. PG has received grant support from the University Hospital of Bordeaux. LCR has received personal fees from ReCor Medical. APe has received personal fees from Quantum Genomics and grant support from Ablative Solutions, Quantum Genomics, and ReCor Medical. JB has received grant support from ReCor Medical and Ablative Solutions. MJB has received personal fees from ReCor Medical and Medtronic. JD has received grant support from ReCor Medical, Medtronic, Boston Scientific, Abbott Vascular, Acist Medical, AstraZeneca, Pie Medical, and Pulse Cath, and personal fees from ReCor Medical, Medtronic, Acist Medical, Boston Scientific, Pie Medical, and Pulse Cath. MDL has received personal fees from ReCor Medical, Medtronic, CVRx, Ablative Solutions, Vascular Dynamics, ROX Medical, and Tarilan Laser Technologies, and grants from Medtronic. FM is supported by Deutsche Gesellschaft für Kardiologie and Deutsche Forschungsgemeinschaft (SFB TRR 219); and has received grant support and personal fees from ReCor Medical, Medtronic, Berlin Chemie, Bayer, and Boehringer Ingelheim. RES has received grant support and personal fees from ReCor Medical, Medtronic, and Ablative Solutions. ASPS has received personal fees from ReCor Medical, Medtronic, Boston Scientific, and Philips. MAW has received personal fees from ReCor Medical, Medtronic, Boston Scientific, and Ablative Solutions. APa has received grant support and personal fees from ReCor Medical, Medtronic, and Ablative Solutions. DH reports institutional funding to Stamford Hospital from ReCor Medical. SB has received grant support from Abbott Vascular, the National Heart, Lung, and Blood Institute, and REATA; and personal fees from Abbott Vascular, Biotronik, REATA, Amgen, Pfizer, Boehringer Ingelheim, and Meril. JW has received personal fees from ReCor Medical and Medtronic. NCB is an employee of ReCor Medical and is the author on multiple patents in the field of renal denervation. HR-S is an employee of ReCor Medical. LC is an employee of ReCor Medical. CKM is an employee of North American Science Associates and a contractor for ReCor Medical. AJK reports institutional funding (in addition to research grants, institutional funding includes fees paid for speaking engagements or consulting) to Columbia University or the Cardiovascular Research Foundation (New York, NY, USA) from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, Cardiovascular Systems, CathWorks, Siemens, Philips, and ReCor Medical. AJK also reports travel expenses or meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, Cardiovascular Systems, CathWorks, Siemens, Philips, Chiesi, OpSens, Zoll, Regeneron, and ReCor Medical. All other authors declare no competing interests., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Aims: We assessed morphological features of near-infrared spectroscopy (NIRS)-detected lipid-rich plaques (LRPs) by using optical coherence tomography (OCT) and intravascular ultrasound (IVUS)., Methods and Results: IVUS-NIRS and OCT were performed in the two non-infarct-related arteries (non-IRAs) in patients undergoing percutaneous coronary intervention for treatment of an acute coronary syndrome. A lesion was defined as the 4 mm segment with the maximum amount of lipid core burden index (maxLCBI4mm) of each LRP detected by NIRS. We divided the lesions into three groups based on the maxLCBI4mm value: <250, 250-399, and ≥400. OCT analysis and IVUS analysis were performed blinded for NIRS. We measured fibrous cap thickness (FCT) by using a semi-automated method. A total of 104 patients underwent multimodality imaging of 209 non-IRAs. NIRS detected 299 LRPs. Of those, 41% showed a maxLCBI4mm <250, 39% a maxLCBI4mm 251-399, and 19% a maxLCBI4mm ≥400. LRPs with a maxLCBI4mm ≥400, as compared with LRPs with a maxLCBI4mm 250-399 and <250, were more frequently thin-cap fibroatheroma (TCFA) (42.1% vs. 5.1% and 0.8%; P < 0.001) with a smaller minimum FCT (80 μm vs. 110 μm and 120 μm; P < 0.001); a higher IVUS-derived percent atheroma volume (53% vs. 53% and 44%; P < 0.001) and a higher remodelling index (1.08 vs. 1.02 and 1.01; P < 0.001). MaxLCBI4mm correlated with OCT-derived FCT (r = 0.404; P < 0.001) and was the best predictor for TCFA with an optimal cut-off value of 401 (area under the curve = 0.882; P < 0.001)., Conclusion: LRPs with increasing maxLCBI4mm exhibit OCT and IVUS features of presumed plaque vulnerability including TCFA morphology, increased plaque burden, and positive remodelling., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Background The need for new permanent pacemaker implantation (PPI) after Transcatheter Aortic Valve Implantation (TAVI) remains a critical issue. Membranous Septum (MS) length is associated with PPI after TAVI. The aim of this study was to identify different MS thresholds for the contemporary THV-platforms. Methods This retrospective, case-control study enrolled all patients who underwent a successful TAVI procedure with contemporary THV-platforms in the Erasmus University Medical Center between January 2016 and March 2020. The follow-up period for new PPI was 30 days. MS-length was determined by Computed Tomography. Results The study consisted 653 TAVI patients with median age 80.6 years (IQR 74.7-84.8). New PPI occurred in 120 patients (18.4%). Patients with new PPI had a shorter MS-length (2.9 mm (IQR 2.3-4.3) vs. 4.2 mm (IQR 2.9-5.7), p < 0.001). MS-length < 3 mm identified a high-risk phenotype with 30.3% PPI-rate (OR 6.5 [95%CI 2.9-14.9]), MS-length 3-6 mm an intermediate-risk phenotype with 15.4% PPI-rate (OR 2.7 [95%CI 1.2-6.2]) and MS > 6 mm a low-risk phenotype with a 6.3% PPI-rate (reference). For the Lotus valve, there was no significant difference in PPI-rates between the high-risk (45.8%, OR 3.5 [95%CI 0.8-15.1]) and low-risk group (20%). By multivariate analysis MS-length, Agatston-score, use of Lotus valve, and ECG with first-degree AV block, RBBB or bifascular block were independent predictors for new PPI. Conclusion MS-length was an independent predictor for new PPI post-TAVI. Three phenotypes were found based on MS-length. MS < 3 mm was universally associated with a high risk for new PPI (>30%). MS > 6 mm represented a low-risk phenotype with PPI-rate < 10%. PPI-rate varied per THV type in the intermediate phenotype. PPI-rate with Lotus was high regardless of MS-length., Competing Interests: Declaration of Competing Interest None., (Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.)

High wall shear stress (WSS) and near-infrared spectroscopy (NIRS) detected lipid-rich plaque (LRP) are both known to be associated with plaque destabilization and future adverse cardiovascular events. However, knowledge of spatial co-localization of LRP and high WSS is lacking. This study investigated the co-localization of LRP based on NIRS and high WSS. Fifty-three patients presenting acute coronary syndrome underwent NIRS-intravascular-ultrasound (NIRS-IVUS) imaging of a non-culprit coronary artery. WSS was obtained using WSS profiling in 3D-reconstructions of the coronary arteries based on fusion of IVUS-segmented lumen and CT-derived 3D-centerline. Thirty-eight vessels were available for final analysis and divided into 0.5 mm/45° sectors. LRP sectors, as identified by NIRS, were more often colocalized with high WSS than sectors without LRP. Moreover, there was a dose-dependent relationship between lipid content and high WSS exposure. This study is a first step in understanding the evolution of LRPs to vulnerable plaques. Graphical Abstract.

Little data are available on access strategy outcomes for cardiac catheterizations in patients with prior coronary artery bypass graft surgery (CABG). We investigated the effect of transradial access (TRA) and transfemoral access (TFA) on short-term major vascular complications (MVC) and long-term major adverse cardiovascular events (MACE). In this single-center, retrospective cohort study, 1084 patients met our inclusion criteria (TRA = 469; TFA = 615). The cumulative incidence for the primary safety endpoint MVC at 30 days (a composite of major bleeding, retroperitoneal hematoma, dissection, pseudoaneurysm, and arteriovenous fistula) was lower with TRA (0.7% vs 3.0%, P < .01) and this difference remained significant after propensity score adjustment (odds ratio: 0.24; 95% CI, 0.07-0.83; P = .024). The cumulative incidence for the primary efficacy endpoint MACE at 36 months (a composite of all-cause mortality, myocardial infarction, stroke, and urgent target vessel revascularization) was 28.6% with TRA and 27.6% with TFA, respectively. Kaplan-Meier curves showed no difference for the primary efficacy endpoint ( P = .65). Contrast use (mL) was significantly lower with TRA (130 [100-180] vs 150 [100-213], P < .01). In conclusion, in patients with prior CABG, TRA was associated with significantly fewer short-term MVC and contrast use, but not with a difference in long-term MACE, compared with TFA.

Objectives: To study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers., Background: The MANTA is a novel plug-based device for large bore arteriotomy closure., Methods: We included all eligible patients who underwent transfemoral large bore percutaneous procedures. Exclusion criteria were per operator's discretion and included severe calcification or marked tortuosity of the access vessel, presence of marked obesity/cachexia or a systolic blood pressure above 180 mmHg. The primary performance endpoint was time to hemostasis. Primary and secondary safety endpoints were major and minor access site related vascular complications up to 30 days, respectively. Vascular complications were adjudicated by an independent clinical event committee according to VARC-2 criteria. We performed multivariable logistic regression to estimate the effect of baseline and procedural characteristics on any and major vascular complications., Results: Between February 2018 and July 2019 500 patients were enrolled undergoing Transcatheter aortic valve replacement (TAVR, N = 496), Balloon aortic valvuloplasty (BAV, N = 2), Mechanical circulatory support (MCS, N = 1) or Endovascular aneurysm repair (EVAR, N = 1). Mean age was 80.8 ± 6.6 years with a median STS-score of 2.7 [IQR 2.0-4.3] %. MANTA access site complications were major in 20 (4%) and minor in 28 patients (5.6%). Median time to hemostasis was 50 [IQR 20-120] sec. Severe femoral artery calcification, scar presence in groin, longer procedure duration, female gender and history of hypertension were independent predictors for vascular complications., Conclusion: In this study, MANTA appeared to be a safe and effective device for large bore access closure under real-world conditions., (© 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

This article provides supplementary tables and figures to the research article: Frequency, Impact and Predictors of Access Complications with Plug-Based Large-Bore Arteriotomy Closure - A patient level meta-analysis [1]. The data provide insight in the type and management of access complications related to the plug-based MANTA vascular closure device (VCD) for large-bore catheter-based cardiovascular interventions. Since MANTA is mostly used in transcatheter aortic valve replacement (TAVR) procedures, this article also contains a sub-group analysis on TAVR procedures using contemporary valve-platforms. Further, data describing MANTA hemostasis times and mortality causes are included. For this dataset, individual patient data were derived from a European and a North American device approval study (the Conformite Européene [CE] mark study and the investigational device exemption SAFE-MANTA study [2,3]) in addition to a post-approval registry (the MARVEL registry [4]) covering a total of 891 patients who were enrolled between 2015 and 2019 across 28 investigational sites. Eligibility criteria were most stringent in the SAFE MANTA study (38% of patients) whereas the MARVEL registry applied liberal and only relative exclusion criteria (56% of patients). A total of 78 Roll-in cases (i.e. first or second time operator use of the MANTA VCD) who were excluded from analysis in SAFE MANTA were included in the present to evaluate a potential learning curve effect. Therefore, this dataset reflects the largest study population undergoing arteriotomy closure with the MANTA VCD by operators at various levels of experience, which can be valuable to further build on research regarding percutaneous large-bore arteriotomy management., Competing Interests: Dr. Van Mieghem reports receiving grant support from Teleflex. The other authors declare that they have no known competing financial interests or personal relationships which have or could be perceived to have influenced the work reported in this article., (© 2021 The Authors. Published by Elsevier Inc.)