Hyperemic hemodynamic characteristics of serial coronary lesions assessed by pullback pressure gradients.

Candreva A, Mizukami T, Sonck J, Munhoz D, ... Perera D, Collet C
Objectives
To characterize hemodynamics of serial coronary stenoses using fractional flow reserve (FFR) pullbacks and the pullback pressure gradients (PPG) index.
Background
The cross-talk between stenoses within the same coronary artery makes the prediction of the functional contribution of each lesion challenging.
Methods and results
One-hundred seventeen patients undergoing coronary angiography for stable angina were prospectively recruited. Serial lesions were defined as two or more narrowings with visual diameter stenosis >50% on conventional angiography. Motorized FFR pullback tracings were obtained at 1 mm/s. Pullbacks were visually adjudicated as presenting two, one, and no focal pressure drops. The pattern of disease (i.e., focal or diffuse) was quantified using the PPG index. Twenty-five vessels presented serial lesions (mean PPG 0.48 ± 0.17). Two, one or no focal pressure drops were observed in 40% (n = 10; PPG 0.59 ± 0.17), 52% (n = 13; PPG 0.44 ± 0.12) and 8% of cases (n = 2; PPG 0.27 ± 0.01; p-value = 0.01). Distal FFR was similar between vessels with two, one and no focal pressure drops in the pullback curve (p-value = 0.27). The PPG index independently predicted the presence of two focal pressure drops in the pullback curve (p = 0.04).
Conclusions
FFR pullbacks in serial coronary lesions exhibit three distinct functional patterns. High PPG was associated with pullback curves presenting two pressure drops. The PPG provides a quantitative assessment of the pattern of coronary artery disease in cases with serial lesions and might be useful to assess the appropriateness of percutaneous revascularization.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Jul 2021; epub ahead of print

One-year mortality in NSTEMI patients is unaffected by timing of PCI within the first week of admission: Results of a real-world cohort analysis.

Fagel ND, Amoroso G, Rabbering T, Gescher F, ... de Winter RJ, Riezebos RK
Objectives
We aimed to explore the impact of time to percutaneous coronary intervention (PCI) (T2P) on 1-year mortality in non-ST-elevation myocardial infarction (NSTEMI) patients.
Background
The current guidelines recommend an early invasive strategy for NSTEMI patients. However, impact of an early invasive strategy on mortality is a matter of debate. For that reason, real world data are of great value to determine the optimal treatment window.
Methods
This retrospective single center cohort study was performed in a high-volume PCI center in Amsterdam, The Netherlands. Intermediate- and high-risk NSTEMI patients undergoing PCI were included. The main discriminant was timing of PCI after admission (T2P), stratified according to different time windows (<24 h, 24-72 h, 72 h-7 days or >7 days). We analyzed 1-year mortality and the time distribution of overall survival.
Results
In total, 848 patients treated between January 1, 2016 and January 1, 2018 were included in the analysis. T2P was <24 h in 145 patients, 24-72 h in 192 patients, 72 h-7 days in 275 patients, and >7 days in 236 patients. The mean GRACE-risk score was 127.1 (SD 28.7), 130.0 (33.1), 133.8 (32.1), and 148.7 (34.6) respectively, p = <0.001. After adjusting for confounders, 1-year mortality in patients with T2P <24 h did not significantly differ when compared with T2P 24-72 h (OR = 1.08; 95% CI = 0.33-3.51) and T2P 72 h-7 days (OR 1.72; 95% CI = 0.57-5.21) but was significantly higher in T2P >7 days (OR = 3.20; 95% CI = 1.06-9.68).
Conclusions
In an unselected cohort of patients with NSTEMI, treatment by PCI <24 h did not lead to improved survival as compared to aT2P <7 days strategy. Delay in PCI >7 days after admission resulted in worse outcome.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Jul 2021; epub ahead of print

Causes and predictors of mortality after transcatheter mitral valve implantation in patients with severe mitral annulus calcification.

Urena M, Lemann T, Chong-Nguyen C, Brochet E, ... Vahanian A, Himbert D
Objectives
To evaluate the causes and predictors of mortality after valve-in-mitral annulus calcification (MAC) transcatheter mitral valve implantation (TMVI).
Background
Conventional surgical mitral valve replacement is associated with a high risk in patients with mitral valve disease associated with severe MAC. In this population, TMVI may be an attractive alternative option. However, its prognostic factors are poorly understood.
Methods
All patients undergoing valve-in-MAC TMVI from 2013 to 2018 in our center were included. Indication for TMVI relied on the judgment of the local heart team. Patients were followed at 30 days and 1 year.
Results
A total of 34 patients underwent valve-in-MAC TMVI. The mean age was 79 ± 11 years and 73% of patients were women. Their mean EuroSCORE 2 was 8 ± 7%. The transseptal approach was used in 79% of patients and a hybrid transatrial in 29%. Balloon expandable transcatheter heart valves were used in all the patients. Technical success was achieved in 76% of the patients. Thirty-day and 1-year all-cause mortality rates were 14.7% and 32.4%, respectively. The main two causes of 1-year mortality were congestive heart failure (8.8%) and infective endocarditis (5.9%). In multivariate analysis, the only predictor of 1-year mortality was the presence of periprothetic mitral regurgitation grade 2 (HR, 5.69; 95%CI, 1.59-27.88, p = 0.032).
Conclusion
Early and mid-term mortality remains high after valve-in-MAC TMVI and seems to be associated with the presence of paravalvular mitral regurgitation. However, whether the latter is a prognostic factor or marker remains to be determined to improve clinical outcomes in this high-risk population.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Jul 2021; epub ahead of print

Long-term outcomes of patients with chronic inflammatory diseases after percutaneous coronary intervention.

Marcusohn E, Zukermann R, Kerner A, Roguin A, Kobo O
Objective
To assess the long-term outcomes of patients with chronic inflammatory diseases who underwent percutaneous coronary intervention (PCI).
Methods
A Retrospective cohort study of all adult patients who underwent PCI in a large tertiary care center from January 2002 to August 2020.
Results
A total of 12,951 patients underwent PCI during the study period and were included in the cohort. The population of chronic inflammatory diseases includes 247 (1.9%) patients; 70 with inflammatory bowel disease (IBD) and 173 with autoimmune rheumatic diseases (AIRD). The composite endpoint of mortality, acute coronary syndrome (ACS) or admission due to acute heart failure was similar at 30 days and more frequent in the inflammatory disease group (42.8% in AIRD group, 35.7% in the IBD group and 29.6% in the noninflammatory group, p < 0.0001). The adjusted cox regression model found a statistically significant increased risk of the composite primary endpoints of around 40% for patients both with AIRD and IBD. Readmission due to ACS was also increases at 30 days in the AIRD group compared to the noninflammatory group (0.6% vs. 0.1%, p < 0.001) and 1 year (37.6% for the AIRD group, 34.3% in the IBD group and 25.5% in the noninflammatory group (p < 0.0001). Patients with inflammatory diseases were found to have a significantly increased risk congestive heart failure admissions at 1 year in a subgroup analysis of patients with myocardial infarction.
Conclusion
Patients with AIRD and IBD are at higher risk for cardiovascular events in long-term follow up once diagnosed with CAD and treated with PCI.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 13 Jul 2021; epub ahead of print

The role of neighborhood disadvantage in predicting mortality in patients after transcatheter aortic valve replacement.

Goitia J, Phan DQ, Lee MS, Moore N, ... Brar SS, Zadegan R
Background
Neighborhoods have a powerful impact on health. Prior investigations into disparities associated with transcatheter aortic valve replacement (TAVR) have focused on race and access to the procedure. We sought to investigate the role of neighborhood disadvantage on mortality post-TAVR.
Methods
Patients who underwent TAVR at Kaiser Permanente Los Angeles Medical Center between June, 2011 and March, 2019 were evaluated. Neighborhood disadvantage was defined using the area deprivation index, an established and validated index that considers multiple socioeconomic metrics. Cutoffs used for disadvantage were national percentile ≥25% and state decile ≥6. Cox proportional hazards regression analysis was used to assess outcomes.
Results
A total of 668 patients (age 82.1 ± 7.5 years, 49% female) were included, of which 215 (32.2%) were from disadvantaged neighborhoods by state decile, and 167 (25%) by national percentile. At a median follow-up of 18.8 months (interquartile range 8.7-36.5 months), neighborhood disadvantage was independently associated with increased all-cause mortality (National percentile: hazard ratio [HR] 1.91, 95% confidence interval [CI] 1.35-2.69; state decile: HR 1.68, 95% CI 1.21-2.34). On propensity scored analysis, neighborhood disadvantaged remained independently associated with increased all-cause mortality (National percentile: IPTW HR 1.86, 95% CI 1.52-2.28, PSM HR 1.67, 95% CI 1.11-2.51; state decile: IPTW HR 1.55, 95% CI 1.26-1.91, PSM HR 2.0, 95% CI 1.33-2.99).
Conclusion
Living in a disadvantaged neighborhood was independently associated with increased mortality post-TAVR on multivariate and propensity score matched analysis. Further investigations into the role of neighborhood disadvantage are needed to address disparities and improve outcomes post-TAVR.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 13 Jul 2021; epub ahead of print

Clinical predictors and impact of postoperative mean gradient on outcome after transcatheter edge-to-edge mitral valve repair.

Oguz D, Padang R, Pislaru SV, Nkomo VT, ... Rihal CS, Thaden JJ
Background
The predictors and clinical significance of increased Doppler-derived mean diastolic gradient (MG) following transcatheter edge-to-edge mitral valve repair (MVTEER) remain controversial.
Objective
We sought to examine baseline correlates of Doppler-derived increased MG post-MVTEER and its impact on intermediate-term outcomes.
Methods
Patients undergoing MVTEER were analyzed retrospectively. Post-MVTEER increased MG was defined as >5 mmHg or aborted clip implantation due to increased MG intraprocedurally. Baseline MG and 3D-guided mitral valve area (MVA) by planimetry were retrospectively available in 233 and 109 patients.
Results
243 patients were included; 62 (26%) had MG > 5 mmHg post-MVTEER or aborted clip insertion, including 7 (11%) that had aborted clip implantation. Mortality occurred in 63 (26%) during a median follow up of 516 days (IQR 211, 1021). Increased post-MVTEER MG occurred more frequently in females (44% vs. 16%, p <  0.001), those with baseline MVA <4.0 cm² (71% vs. 16%), baseline MG ≥4 mmHg (61% vs. 20%), or multiple clips implanted (33% vs. 21%, p = 0.04). Increased post-MVTEER MG was associated with increased subsequent mortality compared to those with normal gradient (HR 1.91 95% CI 1.15-3.18 p = 0.016) as was aborted clip insertion compared to all others (HR 5.23 95% CI 2.06-13.28 p <  0.001).
Conclusions
Smaller baseline MVA and increased baseline MG are associated with increased MG post-MVTEER and patients with a Doppler-derived post-MVTEER MG >5 mmHg suffered excess subsequent mortality. In high risk patients considered for MVTEER, identification of those at risk of iatrogenic mitral stenosis with MVTEER is important as they may be optimally treated with alternate surgical or transcatheter therapies.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 09 Jul 2021; epub ahead of print

Coronary microcirculation assessment using functional angiography: Development of a wire-free method applicable to conventional coronary angiograms.

Mejia-Renteria H, Lee JM, Choi KH, Lee SH, ... Koo BK, Escaned J
Objectives
We aimed to develop a novel wire- and adenosine-free microcirculatory resistive index from functional angiography (angio-IMR) to estimate coronary microcirculatory resistance, and to investigate how this method can improve clinical interpretation of physiological stenosis assessment with quantitative flow ratio (QFR).
Background
Hyperemic index of coronary microcirculatory resistance (IMR) is a widely used tool to assess microcirculatory dysfunction. However, the need of dedicated intracoronary wire and hyperemia limits its adoption in clinical practice.
Methods
We performed our study in two separate stages: (1) development of a formula (angio-IMR) to estimate IMR from resting angiograms and aortic pressure (Pa), and (2) validation of the method in a clinical population using invasively measured IMR as reference. Additionally, QFR diagnostic performance was assessed considering angio-IMR values.
Results
We developed the formula: angio-IMR = (Pa-[0.1*Pa])*QFR*e-Tmn (where e-Tmn is an estimation of hyperaemic mean transit time) and validated it in 115 vessels (104 patients). Angio-IMR correlated well with IMR (Spearman\'s rho = 0.70, p < 0.001). Sensitivity, specificity, positive and negative predictive value, accuracy and area under the curve of angio-IMR to predict IMR were 87.5% (73.2-95.8), 85.3% (75.3-92.4), 76.1% (64.5-84.8), 92.8% (84.9-96.7), 85% and 0.90 (0.83-0.95), respectively. False positive QFR measurements decreased from 19.5% to 8.5% when angio-IMR was incorporated into the QFR interpretation workflow.
Conclusions
Estimation of IMR without physiology wire and adenosine is feasible. Coronary microcirculatory dysfunction causing high IMR can be ruled-out with high confidence in vessels with low angio-IMR. Awareness of angio-IMR contributes to a better clinical interpretation of functional stenosis assessment with QFR.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Jul 2021; epub ahead of print

Polymer-free Biolimus-A9 coated thin strut stents for patients at high bleeding risk 1-year results from the LEADERS FREE III study.

Eberli FR, Stoll HP, Urban P, Morice MC, ... Slama SS, Garot P
Background
In patients at high bleeding risk (HBR), the LEADERS FREE (LF) trial established the safety and efficacy of a polymer-free drug coated (Biolimus-A9) stainless steel stent (SS-DCS) with 30 days of dual antiplatelet treatment (DAPT). In LEADERS FREE III, we studied a new cobalt-chromium thin-strut stent (CoCr-DCS) in HBR patients.
Methods
The CoCr-DCS shares all of the design features of the SS-DCS but has a CoCr stent platform with strut thickness of 84-88 μm. The primary safety endpoint was a composite of cardiac death, myocardial infarction (MI), and definite/probable stent thrombosis. The primary efficacy endpoint was clinically indicated target lesion revascularization. Outcomes were compared to those of LF (non-inferiority to SS-DCS for safety and superiority to SS-BMS for efficacy). Additional propensity-matched comparisons were performed to account for baseline differences.
Results
We recruited 401 HBR patients using identical criteria to the LF trial. At 1 year, the primary safety endpoint was reached by 31/401 (8.0%) of patients treated with the CoCr-DCS versus 35/401 (8.9%) for the propensity-matched cohort (HR: 0.89, [0.55-1.44], p < 0.001 for non-inferiority, 0.62 for superiority). The efficacy endpoint was reached by 16/401 (4.2%) of CoCr-DCS patients versus 41/401 (10.6%) in the propensity-matched cohort (HR: 0.4 [0.2:0.7]) (p = 0.007 for superiority). There was no statistical difference between CoCr-DCS and SS-DCS in terms of efficacy (HR: 1.46 [0.68-3.15], p = 0.33).
Conclusions
The new thin-strut CoCr-DCS proved non-inferior to the SS-DCS for safety, and superior to the BMS for efficacy in HBR patients treated with 30 days of DAPT.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Jul 2021; epub ahead of print

Incidence, treatment, and outcomes of acute myocardial infarction following transcatheter or surgical aortic valve replacement.

Isogai T, Saad AM, Ahuja KR, Shekhar S, ... Ellis SG, Kapadia SR
Objectives
This study aimed to evaluate the incidence, treatment, and outcomes of acute myocardial infarction (AMI) following transcatheter or surgical aortic valve replacement (TAVR or SAVR).
Background
Coronary artery disease is common in patients who undergo aortic valve replacement. However, little is known about differences in clinical features of post-TAVR or post-SAVR AMI.
Methods
We retrospectively identified post-TAVR or post-SAVR (including isolated and complex SAVR) patients admitted with AMI using the Nationwide Readmissions Database 2012-2017. Incidence, invasive strategy (coronary angiography or revascularization), and in-hospital outcomes were compared between post-TAVR and post-SAVR AMIs.
Results
The incidence of 180-day AMI was higher post-TAVR than post-SAVR (1.59% vs. 0.72%; p < 0.001). Post-TAVR AMI patients (n = 1315), compared with post-SAVR AMI patients (n = 1344), were older, had more comorbidities and more frequent non-ST-elevation AMI (NSTEMI: 86.6% vs. 78.0%; p < 0.001). After propensity-score matching, there was no significant difference in in-hospital mortality between post-TAVR and post-SAVR AMIs (14.7% vs. 16.1%; p = 0.531), but the mortality was high in both groups, particularly in ST-elevation AMI (STEMI: 38.8% vs. 29.2%; p = 0.153). Invasive strategy was used less frequently for post-TAVR AMI than post-SAVR AMI (25.6% vs. 38.3%; p < 0.001). Invasive strategy was associated with lower mortality in both post-TAVR (adjusted odds ratio = 0.40; 95% confidence interval = [0.24-0.66]) and post-SAVR groups (0.60 [0.41-0.88]).
Conclusions
AMI, albeit uncommon, was more frequent post-TAVR than post-SAVR. Patients commonly presented with NSTEMI, but the mortality of STEMI was markedly high. Further studies are needed to understand why a substantial percentage of patients do not receive invasive coronary treatment, particularly after TAVR, despite seemingly better outcomes with invasive strategy.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 07 Jul 2021; epub ahead of print

Coronary artery disease burden relation with the presentation of acute cardiac events and ventricular fibrillation.

Kosmopoulos M, Bartos JA, Raveendran G, Goslar T, ... Walser E, Yannopoulos D
Objectives
Evaluate the differences in coronary artery disease (CAD) burden between patients with ischemic resuscitated, ischemic refractory VT/VF OHCA events and N/STEMI.
Background
Refractory out-of-hospital cardiac arrest patients presenting with initial shockable rhythms (VT/VF OHCA) have the highest mortality among patients with acute cardiac events. No predictors of VT/VF OHCA refractoriness have been identified.
Methods
A retrospective cohort design was used to assess baseline characteristics, clinical outcomes, and the angiographic severity of disease among patients with VT/VF OHCA undergoing emergent coronary angiography at the University of Minnesota Medical Center. The Gensini score was calculated for all patients to assess the angiographic burden of CAD. For patients with ischemia-related cardiac arrest, outcomes were further compared to an independent non-OHCA population presenting with N/STEMI.
Results
During the study period, 538 patients were admitted after VT/VF OHCA. Among them, 305 presented with resuscitated, and 233 with refractory VT/VF. 66% of resuscitated and 70% of refractory VT/VF had an underlying, angiographically documented, ischemic etiology. Ischemic resuscitated and refractory VT/VF had significant differences in Gensini score, (80.7 ± 3.6 and 127.6 ± 7.1, respectively, p < 0.001) and survival (77.3% and 30.0%, respectively, p < 0.001). Both groups had a higher CAD burden and worse survival than the non-OHCA N/STEMI population (360 patients). Ischemic refractory VT/VF was significantly more likely to present with chronic total occlusion in comparison to both N/STEMI and ischemic resuscitated VT/VF.
Conclusion
Ischemia-related, refractory VT/VF OHCA has a higher burden of CAD and the presence of CTOs compared to resuscitated VT/VF OHCA and N/STEMI.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 07 Jul 2021; epub ahead of print

Long term outcomes of ultrathin versus standard thickness second-generation drug eluting stents: Meta-analysis of randomized trials.

Hussain Y, Gaston S, Kluger J, Shah T, ... Tirziu D, Lansky A
Objective
Identify the effect of ultrathin drug eluting stents on long term outcomes in coronary artery disease.
Background
Although second-generation drug eluting stents (DES) are superior to first-generation DES, persistence of adverse outcomes has led to continued refinement in design. Ultrathin second-generation DES have been shown to improve outcomes at 1-year follow-up. Beyond 1-year their effect remains unknown.
Methods
PubMed, Embase and Cochrane Database were searched for randomized controlled trials that compared ultrathin (defined as <70 um) to standard thickness second-generation DES. Studies were chosen according to the PROSPERO protocol (CRD42020185374). Data from randomized controlled trials were pooled using random-effects model (Mantel-Haenszel). The primary outcome was target lesion failure (TLF) at 2 years, a composite of cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization. Secondary outcomes included TLF at 3 and 5 years, the components of TLF and definite or probable stent thrombosis. Differences in outcomes between groups were presented in Forest plots as risk ratios (RR) with corresponding 95% confidence intervals (CIs) for each trial.
Results
We identified 18 publications from 10 trials with14,649 patients. At 2-years there was a significant 12% reduction in TLF (RR, 0.88; 95% CI 0.78-0.99; p < 0.05) associated with the use of ultrathin DES. At 3-years, there was a significant 19% reduction in TLF with ultrathin DES (RR, 0.79; 95% CI 0.64-0.98; p < 0.05).
Conclusion
In patients undergoing percutaneous coronary intervention, ultrathin DES improve long term clinical outcomes.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 07 Jul 2021; epub ahead of print

Influence of fractional flow reserve on grafts patency: Systematic review and patient-level meta-analysis.

G Toth G, Collet C, Langhoff Thuesen A, Mizukami T, ... Okkels Jensen L, Barbato E
Objective
To investigate the impact of invasive functional guidance for coronary artery bypass graft surgery (CABG) on graft failure.
Background
Data on the impact of fractional flow reserve (FFR) in guiding CABG are still limited.
Methods
Systematic review and individual patient data meta-analysis were performed. Primary objective was the risk of graft failure, stratified by FFR. Risk estimates are reported as odds ratios (ORs) derived from the aggregated data using random-effects models. Individual patient data were analyzed using mixed effect model to assess relationship between FFR and graft failure. This meta-analysis is registered in PROSPERO (CRD42020180444).
Results
Four prospective studies comprising 503 patients referred for CABG, with 1471 coronaries, assessed by FFR were included. Graft status was available for 1039 conduits at median of 12.0 [IQR 6.6; 12.0] months. Risk of graft failure was higher in vessels with preserved FFR (OR 5.74, 95% CI 1.71-19.29). Every 0.10 FFR units decrease in the coronaries was associated with 56% risk reduction of graft failure (OR 0.44, 95% CI 0.34 to 0.59). FFR cut-off to predict graft failure was 0.79.
Conclusion
Surgical grafting of coronaries with functionally nonsignificant stenoses was associated with higher risk of graft failure.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 06 Jul 2021; epub ahead of print

Efficacy and safety of glycoprotein IIb/IIIa inhibitors in addition to P2Y inhibitors in ST-segment elevation myocardial infarction: A subanalysis of the POPular Genetics trial.

Tavenier AH, Claassens DMF, Hermanides RS, Vos GJA, ... van \'t Hof AWJ, Ten Berg JM
Background
Glycoprotein IIb/IIIa inhibitors (GPI) are still used in patients with ST-segment elevation myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (PCI), although discussion about its clinical benefit is ongoing.
Methods
GPI use was analyzed in this subanalysis of the POPular Genetics trial, which randomized STEMI patients to CYP2C19 genotype-guided treatment (clopidogrel or ticagrelor) or standard treatment with ticagrelor/prasugrel. The composite thrombotic endpoint consisted of cardiovascular death, myocardial infarction (MI), definite stent thrombosis, and stroke at 30 days. The combined bleeding endpoint consisted of Platelet Inhibition and Patient Outcomes (PLATO) major and minor bleeding at 30 days. Univariable and multivariable analyses in addition to a propensity score-matched (PSM) analysis were conducted.
Results
In total, 2378 patients, of whom 1033 received GPI and 1345 did not, were included. In multivariable analysis, GPI administration was associated with fewer thrombotic events (hazard ratio [HR] 0.22, 95% confidence interval [CI] 0.09-0.55) and MIs (HR 0.24, 95% CI 0.08-0.73). Furthermore, GPI administration was associated with an increase in bleedings (HR 2.02, 95% CI 1.27-3.19), driven by minor bleedings (HR 2.32, 95% CI 1.43-3.76), without a significant difference in major bleedings (HR 0.69, 95% CI 0.19-2.57). In the PSM analysis, no significant association was found.
Conclusion
In STEMI patients undergoing primary PCI, GPI administration was associated with a reduction in thrombotic events at a cost of an increase in (mostly minor) bleedings in multivariable analysis, while propensity score analysis did not show significant associations.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 06 Jul 2021; epub ahead of print

Bilateral branch pulmonary artery Pulsta valve implantation for treatment of large right ventricular outflow tract in a high-risk patient.

Kim JY, Kim SH, Jang SI
Percutaneous pulmonary valve implantation (PPVI) has been implemented as a novel alternative strategy to surgical pulmonary valve replacement. However, PPVI has an inevitable limitation: the large right ventricular outflow tract (RVOT) lesions exhibit variable geometry and significant pulmonary regurgitation (PR). To overcome this limitation, bilateral branch pulmonary artery (PA) valve implantations using Melody or Sapien valves have been attempted and have shown a reduction in right ventricular volume with clinical benefits in the intermediate term. Nevertheless, these trials also have constraints of large branch PA size. Recently, a feasibility study using the Pulsta valve (Tae Woong Medical Co, Gyeonggi-do, South Korea) for native RVOTs was reported; the diameter of the Pulsta valve ranges from 18 to 32 mm. Herein, we present a successful percutaneous bilateral branch PA valve implantation using two 32 mm Pulsta valves in a 59-year-old man who showed right heart failure with severe pulmonary regurgitation despite several open heart surgeries for tetralogy of Fallot. The main PA was measured to be 49 mm, and both the right and left PAs were measured to be 30 mm.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 06 Jul 2021; epub ahead of print

The need for future coronary access following surgical or transcatheter aortic valve replacement.

Hermiller JB, Gunnarsson CL, Ryan MP, Moore KA, Clancy SJ, Irish W
The aim of the study was to estimate the percentage of Medicare patients needing coronary access for percutaneous coronary intervention (PCI) or coronary angiography following aortic valve replacement (AVR). Indications for TAVR have expanded to include younger and low-risk patients, raising the question of coronary access for future procedures. Medicare patients <80 years old with an AVR between 2011 and 2018 were included. Time-to-event analyses were conducted using Cox hazard models to estimate risk of coronary access up to 7 years after AVR. Model adjustments included age, sex, race, region, comorbidity, concomitant CABG, and smoking. A total of 13,469 Medicare patients (mean age 70.6) met inclusion criteria. Models estimated that 2.5% of patients at 1-year post-index and 17% at over 7 years would need coronary access. For patients who had SAVR (with or without CABG), estimates for coronary access were similar and over 15% after 6.5 years. For TAVR patients, with a previous PCI, 28% at 4.5 years required coronary access, which was higher than TAVR patients without a previous PCI. SAVR patients with and without CAD at baseline were similar; however, TAVR patients with CAD had a 22% rate of coronary access versus 7% for those without at 3 years. Approximately half of patients who needed coronary access returned to the same hospital as their initial AVR. Coronary access is required in a substantial portion of AVR patients especially those with PCI or a history of CAD undergoing TAVR. The need for coronary access may increase as transcatheter AVR becomes accessible to younger patients with a longer life expectancy.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 05 Jul 2021; epub ahead of print

Edwards SAPIEN XT transcatheter pulmonary valve implantation: 5-year follow-up in a French Registry.

Le Ruz R, Plessis J, Houeijeh A, Baruteau AE, ... Hascoët S, Guérin P
Objectives
This study sought to investigate patient intermediate-term outcomes after transcatheter pulmonary valve replacement (TPVR) with Edwards SAPIEN valve.
Background
The Edwards SAPIEN valve, initially designed for percutaneous aortic valve replacement, has been approved for TPVR in patients with dysfunctional right ventricular outflow tracts (RVOT), but only short-term follow-up has been reported.
Methods
From 2011 to 2016, 62 patients undergoing successful TPVR using the SAPIEN XT valve were consecutively included into the study. Primary efficacy and safety endpoints were defined as freedom from valve-reintervention and freedom from infective endocarditis at last follow-up, respectively.
Results
The primary efficacy outcome was met for 87.1% patients after a mean follow-up of 4.6 ± 1.8 years, corresponding to a freedom of reintervention at 5 years of 89% (95% CI 74.8-95.6%). Reinterventions were exclusively due to recurrent obstruction, no significant valvular regurgitation was observed. One case of infective endocarditis was reported, corresponding to a rate of 0.35% per patient-year (95% CI 0.01-2.00%). At 5 years, freedom from infective endocarditis was 98.4% (95% CI 89.1-99.8%). Six patients died or were transplanted due to advanced cardiac failure, without relationship with TPVR. In univariate analysis, reintervention was associated with young age, a smaller tube-graft, a higher pulmonary valve gradient after the procedure and a ratio of largest implanted stent diameter to invasive balloon conduit diameter over 1.35.
Conclusions
This study documents the mid-term safety and efficacy of the Edwards SAPIEN XT valve in patients with dysfunctional RVOT, and identifies a patient profile associated with an uncertain benefit-risk balance.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 05 Jul 2021; epub ahead of print

Mid-term outcomes of the Pulsta transcatheter pulmonary valve for the native right ventricular outflow tract.

Lee SY, Kim GB, Kim SH, Jang SI, ... Kang IS, Kim YH
Objectives
The aim of this study is to present the mid-term outcomes of Pulsta valve.
Background
The Pulsta valve is a Self-expandable knitted nitinol-wire stent mounted with a treated tri-leaflet α-Gal-free porcine pericardial valve for percutaneous pulmonary valve implantation (PPVI) in patients with native right ventricular outflow tract (RVOT) lesions.
Methods
A multi-center clinical trial using Pulsta valve® was designed for patients with severe pulmonary regurgitation (PR) in the native RVOT in multiple centers in South Korea and 25 patients were enrolled. Before PPVI, severe PR (mean PR fraction: 45.5 ± 6.9%) and enlarged RV volume (mean indexed RV end-diastolic volume; 169.7 ± 13.0 ml/m² ) was present. The mean age was 21.6 ± 6.6 years old.
Results
All patients were successfully implanted with 26, 28, or 32 mm diameter of Pulsta valve loaded on the 18 or 20 French delivery catheters. At 6 months follow up, indexed RV end-diastolic volume was decreased to 126.9 ± 16.9 ml/m² . At mean 33.1 ± 14.3 months follow-up, the mean value of mean pressure gradient in Pulsta valve was 6.5 ± 3.0 mmhg without significant PR. There was no serious device-related adverse event.
Conclusions
A multi-center clinical trial was completed successfully with planned Pulsta valve implantation and demonstrated good mid-term effectiveness without device-related serious adverse events.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 05 Jul 2021; epub ahead of print

Hemodynamic changes during transcatheter atrial septal defect closure predict midterm heart failure deterioration in adults.

Yamamoto H, Shinke T, Otake H, Terashita D, ... Tanaka H, Hirata KI
Objectives
To investigate whether hemodynamic changes during balloon occlusion test (BOT) predict future heart failure (HF) deterioration after transcatheter atrial septal defect closure (tASD-closure).
Background
Midterm HF deterioration can sometimes occur after tASD-closure in adults. Whether hemodynamic changes during tASD-closure can help identify patients at risk is unknown.
Methods
This prospective observational study enrolled 86 consecutive adult patients who underwent tASD-closure. Hemodynamic parameters, including pulmonary capillary wedge pressure (PCWP), were measured at baseline, during BOT, and after tASD-closure. The changes in PCWP during BOT and after tASD-closure were defined as ΔPCWP (Occ-Pre) and ΔPCWP (Post-Pre), respectively. Clinical parameters were evaluated before tASD-closure and during the 3-month follow-up. We assessed the occurrence of HF deterioration (HF requiring hospitalization or additional diuretics) during a 2-year follow-up period and categorized patients into HF (+) and HF (-) groups accordingly. The aforementioned parameters were compared between groups.
Results
Midterm HF deterioration occurred in 12 patients (13.9%). Compared to the HF (-) group, the HF (+) group presented a significantly higher ΔPCWP (Occ-Pre) (9.5 ± 4.4 mmHg vs. 3.0 ± 3.3 mmHg; p < 0.001) and ΔPCWP (Post-Pre) (4.0 ± 2.8 mmHg vs. 0.6 ± 1.8 mmHg; p = 0.004). Receiver operating characteristic curve analysis showed that the ΔPCWP (Occ-Pre) cutoff value of 5.5 mmHg had excellent ability to predict HF deterioration (Area under the curve 0.886 [0.779-0.993], p < 0.001; sensitivity 0.917, specificity 0.824).
Conclusions
Increases in PCWP during BOT predict midterm HF deterioration after tASD-closure. Close surveillance may be needed in patients with a ΔPCWP (Occ-Pre) >5 mmHg.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 05 Jul 2021; epub ahead of print

Fractional flow reserve guided versus angiographic guided surgical revascularization: A meta-analysis.

Bruno F, D\'Ascenzo F, Marengo G, Manfredi R, ... Rinaldi M, De Ferrari GM
Background
Clinical benefits of FFR (Fraction Flow Reserve) driven CABG (Coronary Artery Bypass Graft) remain to be established.
Methods
All randomized controlled trials (RCTs) and observational studies with multivariable adjustement were included. MACE (Major Adverse Cardiac Events) was the primary end point, while its single components (death, myocardial infarction, and total vessel revascularization [TVR]) along with number of anastomoses, on pump procedures and graft occlusion at angiographic follow-up were the secondary ones. Each analysis was stratified for RCTs versus observational studies.
Results
Four studies (two RCTs and two observational) were included, enrolling 983 patients, 542 angio-guided and 441 FFR-guided. Mean age was 68.45 years, 79% male, with a mean EuroSCORE I of 2.7. Coronary lesions were located in 37% of patients in the left anterior descending artery, 32% in the circumflex artery, and 26% in the right coronary artery. After a mean follow-up of 40 months, risk of MACE did not differ (OR 0.86 [0.63-1.18]) as that of all cause death (OR 0.86 [0.59-1.25]), MI (OR 0.57 [0.30-1.11]) and TVR (OR 1.10 [0.65-1.85]). FFR-driven CABG reduced on-pump procedures (OR 0.58 [0.35-0.93]) and number of anastomoses (-0.40 [-0.80: -0.01]) while incidence of graft occlusion at follow-up did not differ (OR 0.59 [0.30-1.15], all CI 95%).
Conclusion
Fraction flow reserve driven CABG reduced the number of anastomoses and of on-pump procedures without increasing risk of MACE and without reducing graft occlusion at angiographic follow-up. ID CRD42020211945.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E18-E23

Association between mid-term worsening renal function and mortality after transcatheter aortic valve replacement in patients with chronic kidney disease.

Phan DQ, Lee MS, Aharonian V, Mansukhani P, ... Brar SS, Zadegan R
Introduction
Chronic kidney disease (CKD), acute kidney injury (AKI) and worsening renal function at 30 days after transcatheter aortic valve replacement (TAVR) portend poor outcomes. We sought to evaluate the association between worsening renal function at 3-6 months and mortality among patients with baseline renal dysfunction undergoing TAVR.
Methods
This is a retrospective study of patients with glomerular filtration rate (GFR) < 60 ml/min undergoing TAVR between June 2011 and March 2019 at the Regional Cardiac Catheterization Lab at Kaiser Permanente Los Angeles. Worsening renal function at 3-6 months post-TAVR was defined as: increase in serum creatinine >1.5 times compared to baseline, absolute increase of ≥0.3 mg/dl, or initiation of dialysis.
Results
Of 683 patients reviewed, 176 were included in the analysis (median age 84 [IQR 79-88] years, 56% female). Of these, 27 (15.3%) had worsening renal function. AKI post-TAVR (OR 2.9, 95% CI 1.1-7.4, p = .03) and transfusion of ≥4 units red blood cells (OR 8.4, 95% CI 1.2-59, p = .03) were independent predictors of worsening renal function. Worsening renal function increased risk for mortality (HR 2.2, 95% CI 1.17-4.27, p = .015) at a median follow-up of 691 days. Those with improved/stable function with baseline GFR < 60 ml/min had comparable mortality risk to those with baseline GFR ≥ 60 ml/min (18% vs. 16.5%; HR 1.1, 95% CI 0.72-1.75, p = .62).
Conclusion
Among patients with baseline renal dysfunction, only 15% developed worsening renal function at 3-6 months after TAVR, which was associated with increased mortality. Predictors for worsening renal function include AKI and blood transfusions. Preventative measures peri-procedurally and continued monitoring post-discharge are warranted to improve outcomes.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:185-194

Optical coherence tomography analysis of late lumen enlargement after paclitaxel-coated balloon angioplasty for de-novo coronary artery disease.

Sogabe K, Koide M, Fukui K, Kato Y, ... Nakamura T, Matoba S
Background
Paclitaxel-coated balloon angioplasty for de-novo coronary artery lesions causes late lumen enlargement (LLE), however, the mechanisms and predictors of LLE have not been elucidated.
Methods and results
We retrospectively analyzed 91 consecutive patients with 95 de-novo coronary lesions, who underwent paclitaxel-coated balloon angioplasty without stenting from August 2018 to July 2019 as well as follow-up coronary angiography and optical coherence tomography (OCT). The mean follow-up duration was 8.2 ± 2.9 months. The target lesion revascularization rate was 7.3%. OCT demonstrated LLE in 50.5% of lesions. The lesions with LLE had a higher incidence of vessel enlargement (76.6 vs. 29.2%, p < .01), regression of plaque or dissection flap (55.3 vs. 10.4%, p < 0.01; 40.4 vs. 14.6%, p < .01, respectively), and reattachment and healing of dissection flaps (74.5 vs. 27.1%, p < .01) compared with those without LLE. Preprocedure thick-cap fibroatheroma plaques and postprocedure deep dissection reaching the tunica media were positive predictors of LLE (hazard ratio, HR 3.74 [1.93-7.25], p < .001; HR 2.04 [1.02-4.05], p < .05, respectively).
Conclusions
OCT analysis after paclitaxel-coated balloon treatment of de-novo coronary artery lesions revealed that the mechanism of LLE was associated with vessel enlargement, healing of dissection flaps, and regression of plaque or dissection flap. Preprocedure thick-cap fibroatheroma plaques and postprocedure deep dissection reaching the tunica media on OCT were predictors of LLE.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E35-E42

Clinical impact of bifurcation angle change between diastole and systole in complex stenting for left main distal bifurcation: The Milan and New-Tokyo (MITO) Registry.

Watanabe Y, Mitomo S, Naganuma T, Takagi K, ... Nakamura S, Colombo A
Objectives
We assessed the impact of pre-percutaneous coronary intervention (PCI) bifurcation angle change (BAC) on clinical outcomes.
Background
There are little available data about the impact of BAC in unprotected left main distal bifurcation lesions (ULMD) PCI.
Methods
We identified consecutive 300 patients with ULMD underwent complex stenting using drug-eluting stent in three high-volume centers (Tokyo and Milan). We measured the widest BA of ULMD at both end-diastole and end-systole before stenting with two-dimensional quantitative coronary angiographic assessment and calculated the BAC value as a difference of two BA value in each lesion. We divided them into small and large BAC group according to the median BAC value (7.2°). The primary endpoint was target lesion failure (TLF), which was defined as a composite of cardiac death, target lesion revascularization (TLR) and myocardial infarction.
Results
TLF rate at 3-year was significantly higher in the large BAC group than in the small BAC group (adjusted hazard ratio [HR] 5.85; 95% confidence interval [CI], 3.40-10.1; p < .001). TLR rate for left main (LM) to left anterior descending artery (LAD) and ostial left circumflex artery (LCXos) at 3-year were significantly higher in large BAC group than in small BAC group (adjusted HR 5.91; 95% CI, 2.03-17.2; p = .001 and adjusted HR 10.6; 95% CI, 5.20-21.6; p < .001, respectively).
Conclusions
A large BAC before stenting is strongly associated with adverse events after complex stenting for ULMD, mainly driven by repeat PCI for restenosis of the LCXos and of the LM-LAD.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E24-E34

Ability of a novel shock index that incorporates invasive hemodynamics to predict mortality in patients with ST-elevation myocardial infarction.

McKenzie A, Zhou C, Svendsen C, Anketell R, ... Yeung M, Stouffer GA
Objective
To determine whether the use of invasively measured hemodynamics improves the prognostic ability of a shock index (SI).
Background
SI such as Admission-SI, Age-SI, Modified SI (MSI), and Age-MSI predict short-term mortality in ST-elevation myocardial infarction (STEMI).
Methods
Single-center study of 510 patients who underwent primary percutaneous coronary intervention. STEMI SI was defined as age × heart rate (HR) divided by coronary perfusion pressure (CPP).
Results
The mean age was 62 ± 14 years, 66% were males with hypertension (69%), tobacco use (38%), diabetes (28%) and chronic kidney disease (6%). The mean HR, systolic blood pressure (SBP), and CPP were 81 ± 18 bpm, 124 ± 28 mmHg, and 52.8 ± 16.3 mmHg, respectively. Patients with STEMI SI ≥182 (n = 51) were more likely to experience a cardiac arrest in the catheterization laboratory (9.8% vs. 2.0%; p = .001), require mechanical circulatory support (47.1% vs. 8.5%; p < .0001) and be treated with vasopressors (56.9% vs. 10.7%; p < .0001) compared to STEMI SI < 182 (n = 459). After multivariate adjustment, patients with STEMI SI ≥182 were 10, 10.1 and 4.8 times more likely to die during hospitalization, at 30 days and at 5 years, respectively. The C statistic of STEMI SI was 0.870, similar to GRACE score (AUC = 0.902; p = .29) and TIMI STEMI score (AUC = 0.895; p = .36).
Conclusion
STEMI SI is an easy to calculate risk score that identifies STEMI patients at high risk of in-hospital death.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:87-94

The incidence, natural history, and predictive factors for tissue protrusion after drug-eluting stent implantation.

Otagaki M, Fujii K, Matsumura K, Noda T, ... Yoshioka K, Shiojima I
Objectives and background
Although tissue protrusion (TP) between the stent struts after stent implantation has been implicate as a potential factor of stent failure, the incidence, natural history, and predictive factor of TP after stent implantation remains unclear. This prospective study evaluated the fate of TP after drug-eluting stent (DES) deployment using optical coherence tomography (OCT).
Method and result
This study analyzed TP for 42 lesions after DES in which three serial OCTs, including preprocedure, postprocedure, and 1-month after the procedure were performed. TP was classified into the five groups: (a) persistent, (b) progressive, (c) healed, (d) regressive, and (e) late-acquired. Immediately after the procedure, 100 TPs in 37 lesions (88%) were identified. Of those, 53 (53%) were persistent, 3 (3%) were progressive, 20 (20%) were healed, and 24 (24%) were regressed at 1-month follow-up. Seven TPs in five patients (13%) were observed only at 1-month follow-up (late-acquired).
Conclusion
In lesions with late-acquired TP, calcified nodule was identified as an underlying plaque morphology on preprocedural OCT. A serial OCT analysis found TP occurred not only immediately after DES implantation, but also 1-month after DES implantation.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E62-E68

Procedural optimization of drug-coated balloons in the treatment of coronary artery disease.

Lee HS, Kang J, Park KW, Ki YJ, ... Koo BK, Kim HS
Objectives
This study aimed to investigate the effects of procedural optimization on the clinical outcomes of using the drug-coated balloon (DCB) in the treatment of coronary artery disease.
Backgrounds
Procedural optimization is considered an essential step in DCB treatment.
Methods
Data of consecutive patients who underwent DCB treatment at the Seoul National University Hospital were collected. The primary outcome was target lesion failure (TLF) at 2 years.
Results
Among 259 patients (309 lesions), TLF was observed in 31 (12.0%) patients. The following were modifiable procedural factors: residual percent diameter stenosis (%DS) after lesion preparation; DCB-to-vessel/stent ratio; time-delay to inflation; and total DCB inflation time. The best cutoff values for these parameters were 20%, 0.95, 25, and 60 s, respectively. The patients were classified based on the number of procedural factors that satisfied adequate criteria. TLF was observed in 7.3% in the fully optimized group, 9.1% in the partially optimized group, and 34.1% in the nonoptimized group over 2 years (p < .001). The adequacy of the four factors for DCB optimization was an independent predictor of TLF (adjusted hazards ratio for each unmet criteria for optimization, 2.05, 95% confidence interval 1.74-2.36, p < .001).
Conclusion
The optimization of the four procedural factors could reduce TLF following DCB treatment.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E43-E52

Sex-specific in-hospital outcomes of transcatheter aortic valve replacement with third generation transcatheter heart valves.

Simard T, Alqahtani F, Hibbert B, Mamas MA, ... Hohmann SF, Alkhouli M
Background
Sex-based differences in transcatheter aortic valve replacement (TAVR) outcomes have been previously documented. However, whether these differences persist with contemporary third generation transcatheter heart valves (THVs) is unknown.
Methods
We utilized Vizient\'s clinical database/resource manager (CDB/RM™) to identify patients who underwent TAVR between January 1, 2018 and March 31, 2020 to compare in-hospital outcomes between males and females. The primary endpoint was in-hospital mortality. Secondary endpoints included key in-hospital complications, length of stay, discharge disposition, and cost. Unadjusted, propensity-score matched and risk-adjusted analyses of outcomes were performed.
Results
During the study period, 44,280 patients (24,842 males, 19,438 females) underwent TAVR. The primary endpoint of in-hospital mortality was higher in females than in males (1.6 vs. 1.1% p < .001) in unadjusted analysis and persisted following propensity matching (1.6 vs. 0.9%, p < .001) and multivariable logistic regression with various risk-adjustment models. In the most comprehensive model adjusting for age, race, and clinical comorbidities, female sex was associated with 34% greater odds of in-hospital death (95% CI 20-50%, p < .001). Unadjusted and risk-adjusted rates of post-TAVR stroke, vascular complication, and blood transfusion were higher in females. Moreover, females demonstrated longer hospitalizations, higher costs and reduced rates of independent discharge home.
Conclusion
Sex-based differences in TAVR in-hospital outcomes persist in contemporary practice with third generation transcatheter heart valves. Further research is needed to assess the reasons for these observed disparities and to identify effective mitigation strategies.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:176-183

Racial disparities in the treatment of aortic stenosis: Has transcatheter aortic valve replacement bridged the gap?

Erinne I, Sethi A, Johannesen J, Kassotis J
Background
Racial disparities in outcomes and utilization of surgical aortic valve replacement (SAVR) for the treatment of severe aortic stenosis (AS) is well known. While transcatheter aortic valve replacement (TAVR) has become more widespread, its impact on racial disparities remains unclear.
Objectives
Our goal was to assess the utilization of SAVR and TAVR and their clinical outcomes among various racial groups.
Methods
The National Inpatient database (2009-2015) was used to study the racial distribution of admissions for SAVR and TAVR, and their impact on inpatient outcomes. Survey estimation commands were used to determine weighted national estimates.
Results
There were 3,445,267; 294,108; and 52,913 inpatient visits for AS, SAVR, and TAVR, respectively. SAVR visits were 86% White, 3.8% Black, 5.5% Hispanic, 1.2% Asian/Pacific Islander (A/PI), 0.4% Native American (NA), and 2.9%; TAVR were 87.7% White, 3.7% Black, 3.8% Hispanic, 1.0% A/PI, 0.2% NA, and 3.5% Other while AS visits were 83.7% White, 6.7% Black, 5.3% Hispanic, 1.7% A/PI, 0.4% NA, and 2.2% Other. Racial minorities generally had more co-morbidities compared with Whites. After SAVR, Black patients had a higher unadjusted inpatient mortality than Whites, however, there was no difference after adjustment for other variables. A/PI were more likely to require a permanent pacemaker after SAVR. Need for blood transfusion was significantly higher among the minorities compared with Whites, except for NA, but there were no racial differences in stroke rates. There was no difference in inpatient mortality, pacemaker implantation, stroke, and bleeding after TAVR, but acute kidney injury occurred more often in Hispanics, A/PI, and \"others\" compared with Whites.
Conclusions
Racial disparities in the treatment of AS continues in the contemporary era; however it was found that TAVR resulted in comparable inpatient outcomes, despite higher comorbidities, and adverse socioeconomic factors in minorities.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:148-156

Optimizing mechanical circulatory support hemodynamics using coronary sinus pacing.

Tahir H, Tonks R, Cox J, Baljepally R
The role of atrioventricular (AV) dyssynchrony as a cause of low Impella device output in cardiogenic shock from acute anterior myocardial infarction (MI) responding to reestablishing AV synchrony has not been previously reported. We present, for the first time, a unique case of AV dyssynchrony causing recurrent hypotension and ventricular fibrillation in such a patient, followed by immediate return to hemodynamic stability after restoring AV synchrony. Our case also highlights the novel use of a Damato multi-polar catheter for coronary sinus pacing to achieve AV synchrony.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E78-E84

A new combined antegrade and retrograde approach for chronic total occlusion recanalization: Facilitated antegrade fenestration and re-entry.

Azzalini L, Carlino M
While antegrade techniques remain the cornerstone of chronic total occlusion (CTO) percutaneous coronary intervention (PCI), operators have often to resort to the retrograde approach in complex occlusions. In particular, lesions with proximal cap ambiguity, unclear vessel course and/or poor distal landing zone are difficult to tackle with either antegrade wiring or antegrade dissection and re-entry (ADR), and often require the retrograde approach. After collateral channel crossing, the retrograde approach usually culminates with either reverse controlled antegrade and retrograde subintimal tracking (CART) or retrograde true lumen crossing. Both techniques usually involve the use of an externalization wire, which requires keeping a higher activate clotting time to prevent thrombosis of the retrograde channel and is potentially associated with risk for donor vessel injury. In 2018, we described antegrade fenestration and re-entry (AFR), a targeted ADR technique in which fenestrations between the false and true lumen are created by antegrade balloon dilatation in the extraplaque space at the level of the distal cap, which are subsequently engaged by a polymer-jacketed wire to achieve re-entry. We hypothesized that AFR can also expedite antegrade crossing of the CTO after a wire has reached the distal vessel in a retrograde fashion. In this report, we present two cases in which we successfully achieved antegrade CTO crossing with AFR following retrograde advancement of a guidewire to the distal cap, in new variant of the technique, which we called \"facilitated AFR\".

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E85-E90

Vascular complications associated with intraaortic balloon pump supported percutaneous coronary intervention (PCI) and clinical outcomes from the British Cardiovascular Intervention Society National PCI Database.

Kinnaird T, Anderson R, Gallagher S, Sharp ASP, ... Nolan J, Mamas M
Introduction
The impact of a vascular complication (VC) in the setting of intraaortic balloon pump (IABP) supported PCI on clinical outcomes is unclear.
Methods
Using data from the BCIS National PCI Database, multivariate logistic regression was used to identify independent predictors of a VC. Propensity scoring was used to quantify the association between a VC and outcomes.
Results
Between 2007 and 2014, 9,970 PCIs in England and Wales were supported by IABP (1.6% of total PCI), with 224 femoral VCs (2.3%). Annualized rates of a VC reduced as the use of radial access for PCI increased. The independent predictors of a VC included a procedural complication (odds ratio [OR] 2.9, p < .001), female sex (OR 2.3, p < .001), PCI for stable angina (OR 3.47, p = .028), and use of a glycoprotein inhibitor (OR 1.46 [1.1:2.5], p = .04), with a lower likelihood of a VC when radial access was used for PCI (OR 0.48, p = .008). A VC was associated with a higher likelihood of transfusion (OR 5.7 [3.5:9.2], p < .0001), acute kidney injury (OR 2.6 [1.2:6.1], p = .027), and periprocedural MI (OR 3.2 [1.5:6.7], p = .002) but not with adjusted mortality at discharge (OR 1.2 [0.8:1.7], p = .394) or 12-months (OR 1.1 [0.76:1.56], p = .639). In sensitivity analyses, there was a trend towards higher mortality in patients experiencing a VC who underwent PCI for stable angina (OR 4.1 [1.0:16.4], p value for interaction .069). Discussion and
Conclusions:
Although in-hospital morbidity was observed to be adversely affected by occurrence of a VC during IABP-supported PCI, in-hospital and 1-year survival were similar between groups.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E53-E61

National trends of utilization and readmission rates with intravascular ultrasound use for ST-elevation myocardial infarction.

Ya\'qoub L, Gad M, Saad AM, Elgendy IY, Mahmoud AN
Background
Randomized trials have confirmed that intravascular ultrasound (IVUS) guidance for percutaneous coronary interventions (PCI) improves long-term clinical outcomes. However, data on real-world utilization of IVUS in ST-elevation myocardial infarction (STEMI) and the impact on short to mid-term outcomes are scarce. We sought to evaluate the utilization and the readmission rates for IVUS-guided PCI in the setting of STEMI.
Methods
Hospitalizations with a primary diagnosis of STEMI undergoing PCI were included from the Nationwide Readmissions Database (NRD) during 2012-2017.
Results
Among 809,601 hospitalizations with STEMI undergoing PCI, 33,644 (4.2%) underwent IVUS-guided PCI. IVUS use increased from 4.2% in 2012 to 5.6% in 2017 (p < .0001). After matching, in-hospital mortality was significantly lower with IVUS use (3.9% vs. 4.6%, p < .0001). The overall readmission rates were similar in both groups. We found that readmission rates due to acute MI at 6 months (5.7% vs. 6%, p = .045) and 11 months (5.1% vs. 6.5%, p = .005) as well as the PCI and mortality rates during readmission at 11 months (2.1% vs. 3%, p = .008, and 0.7% vs. 1.4%, p = .002, respectively) were significantly lower in the IVUS group.
Conclusions
The utilization of IVUS in STEMI appears to be slowly increasing. Although overall readmission rates were similar, IVUS was associated with lower in-hospital mortality, lower rates of readmission due to acute MI at 6 and 11 months, as well as lower PCI and mortality at 11 months. Randomized trials evaluating long-term benefits of IVUS in STEMI are needed.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:1-9

Outcomes of transcatheter aortic valve replacement in end stage liver and renal disease.

Caughron H, Parikh D, Allison Z, Deuse T, Mahadevan VS
Objectives
This study evaluates in-hospital, 30-day, and 1-year outcomes post-transcatheter aortic valve replacement (TAVR) in end stage liver disease (ESLD) and/or end stage renal disease (ESRD) compared with patients without these comorbidities.
Background
TAVR is an alternative to surgical aortic valve replacement in patients with ESLD and ESRD, though current outcomes data are limited.
Methods
We compared 309 patients (N = 29 ESLD and/or ESRD, N = 280 control) age > 18 who underwent transfemoral TAVR from 2014 to 2020 have been compared.
Results
Patients with ESLD and ESRD were younger (69.9 ± 11.7 vs. 79.1 ± 9.8, p < .01) with higher STS-PROM scores (8.1 ± 6.7 vs. 4.6 ± 3.9, p < .01). ESRD and ESLD patients had similar rates of in-hospital major vascular complications (3.4% vs. 3.2%, p = .96), major bleeding events (3.4% vs. 3.2%, p = .95), and mortality (0.0% vs. 1.8%, p = .47). Mortality rates were similar at 30-days (3.4% vs. 2.1%, p = .65) with trend to higher mortality at 6-months (6.9% vs. 3.2%, p = .31) and 1-year (15.4% vs. 7.0%, p = .13). Readmission rates were higher in the ESLD and ESRD cohort at 6-months (53.2% vs. 28.6%, p < .01) and 1-year (65.4% vs. 41.0%, p = .02). One patient received dual kidney-liver transplant, 1 patient received a liver transplant, and 7 additional patients were listed for transplant.
Conclusion
Patients with ESLD and/or ESRD who underwent TAVR had similar mortality at discharge and 30-days compared with patients without these comorbidities with a trend toward increased mortality at 1-year. This study suggests that TAVR is an option for aortic valve disease patients with ESRD and/or ESLD in order to remove cardiac barriers to liver or kidney transplant.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:159-167

Long-term clinical, angiographic, and optical coherence tomography findings of Mg-based bioresorbable scaffold in patients with acute coronary syndrome.

Gutiérrez-Barrios A, Gheorghe LL, Camacho Freire S, Silva E, ... Bretones Del Pino T, Calle Perez G
Background
This study sought to evaluate the clinical outcomes of patients treated with magnesium-based bioresorbable scaffolds (MgBRS) in the context of acute coronary syndromes (ACS) at long-term follow-up (24 months). The study also aims to investigate the MgBRS performance by angiography and the healing and bioresorption pattern by optical coherence tomography (OCT) at 18 months.
Methods
Between December 2016 and December 2018, a total of 90 patients admitted for ACS and treated with MgBRS (Magmaris, Biotronik AG, Bülach, Switzerland) were enrolled in a multicenter prospective study. Clinical follow-up was performed in all patients at 24 months and angiographic and OCT follow-up in 51.5% of patients at 18 months. Serial OCT was available in 33 patients (36.7%).
Results
At a 2-year follow-up, 88.8% were free of symptoms, no cardiac death was reported, and the device-oriented composite event (DOCE): consisting of cardiac death, target vessel myocardial infarction, and target lesion revascularization (TLR) was 13.3%. Stent thrombosis and TLR were observed in 2.2 and 11.1%, respectively. Binary restenosis was observed in 21.7% of cases and in-stent late lumen loss was 0.61 ± 0.75 mm. By serial OCT imaging, the minimal lumen area was significantly reduced greater than 40% (from 6.12 ± 1.59 to 3.5 ± 1.55 mm2, p < .001). At follow-up, area stenosis was 44.33 ± 23.07% and half of the patients presented indiscernible struts. The principal observed mechanism of restenosis was scaffold collapse.
Conclusions
At long-term follow-up, MgBRS implantation in ACS patients showed a high rate of DOCE, mainly caused by clinically driven TLR. MgBRS restenosis was caused by scaffold collapse in most of the cases.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E69-E77

#SoMe for #IC: Optimal use of social media in interventional cardiology.

Goldsweig AM, Galper BZ, Alraies C, Arnold SV, ... Cohen DJ, Aronow HD
Social media allows interventional cardiologists to disseminate and discuss research and clinical cases in real-time, to demonstrate and learn innovative techniques, to build professional networks, and to reach out to patients and the general public. Social media provides a democratic platform for all participants to influence the conversation and demonstrate their expertise. This review addresses the use of social media for these purposes in interventional cardiology, as well as respect for patient privacy, how to get started on social media, the creation of high-impact social media content, and the role of traditional journals in the age of social media. In the future, we hope that interventional cardiology fellowship programs will incorporate social media training into their curricula. In addition, professional societies may adapt to the rapid dissemination of data on social media by developing processes to update guidelines more rapidly and more frequently.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:97-106

Management of dead space thrombosis during decannulation of peripherally inserted venoarterial extracorporeal membrane oxygenation.

Sulimov DS, Markuske M, Desch S, Thiele H
Ischemic complications after percutaneous decannulation of veno-arterial extracorporeal membrane oxygenation (va-ECMO) are not rare and can lead to significant morbidity or even mortality in case of delayed diagnosis or treatment. A possible cause of thromboembolic complications is the formation of thrombus between in the short segment between the large bore retrograde arterial cannula of va-ECMO and the antegrade limb perfusion sheath due to absence of blood flow (dead space). In this case report, we demonstrate a new technique of flushing the dead space to prevent embolic complications during va-ECMO decannulation.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E122-E123

Elective versus urgent in-hospital transcatheter aortic valve implantation.

Kabahizi A, Sheikh AS, Williams T, Tanseco K, ... Cockburn J, Hildick-Smith D
Background
Transcatheter aortic valve implantation (TAVI) is maturing as a treatment option and is now often undertaken during an unscheduled index hospital admission. The aim of this study was to look at procedural and mid-term outcomes of patients undergoing elective versus urgent in-hospital transcatheter aortic valve implantation.
Methods
We identified a total of 1,157 patients who underwent TAVI between November 2007 and November 2019 at the Sussex Cardiac Centre in the UK. We compared the demographics, procedural outcomes, 30-day and 1-year mortality between elective and urgent patients. Emergency and salvage TAVI cases were excluded.
Results
Of the 1,157 patients who underwent the procedure, 975 (84.3%) had elective while 182 (15.7%) had urgent TAVI. Predominant aortic stenosis was more frequent in elective patients (91.7% vs. 77.4%); p < .01), while predominant aortic regurgitation was seen more commonly in the urgent group (11.5% vs. 4.2%; p < .01). Implantation success was similar between the elective (99.1%) and urgent group (99.4%). In-hospital (1.65% vs. 1.3%: p .11), 30 day (3.5% vs. 3.3%: p .81) and 1 year (10.9% vs. 11%; p .81) mortality rates were similar in the elective and urgent groups, respectively.
Conclusions
In contemporary practice, urgent TAVI undertaken on the index admission can be performed at similar risk to elective outpatient TAVI.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:170-175

Edge to edge repair using a MitraClip for severe tricuspid valve regurgitation after a Mustard operation.

Iriart X, Guérin P, Jalal Z, Thambo JB
A 48-year-old who underwent a Mustard operation in 1972 followed by a second cardiac intervention in 1996 for pulmonary venous baffle enlargement and residual baffle leak closure, complicated by recurrent atrial flutter, was admitted to our institution for severe systemic atrio-ventricular valve regurgitation (SAVVR) associated with severely impaired systemic right ventricular (RV) function. After careful preoperative anatomic assessment including three-dimensional transesophageal echocardiography (3DTEE) to define the clipping strategy and computed tomography to optimize the transvenous baffle puncture site, the intervention was performed under general anesthesia, fluoroscopic, and 3DTEE guidance. One XTR MitraClip was successfully implanted, achieving a significant reduction in regurgitation and immediate clinical improvement. The transbaffle puncture was closed using an 8 mm atrial septal defect (ASD) device without residual shunt or obstruction of the venous baffle. Post-operative clinical evaluation showed immediate improvement in the NYHA functional class (from III to II), but the patient presented with recurrent flutter at 1 week after the procedure, which was successfully treated by catheter ablation with another transbaffle approach next to the ASD device. Clinical improvement was maintained at 1- and 6-month follow-up with significant reduction in SAVVR, reduced systemic RV volumes and improved RV ejection fraction. This case demonstrates the feasibility of percutaneous treatment of systemic SAVV in patients with systemic RV after atrial redirection.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E108-E114

Use of edge-to-edge percutaneous mitral valve repair for severe mitral regurgitation in cardiogenic shock: A multicenter observational experience (MITRA-SHOCK study).

Falasconi G, Melillo F, Pannone L, Adamo M, ... Montorfano M, Agricola E
Objectives
The aim of this study was to evaluate the impact of edge-to-edge PMVR on short and mid-term clinical outcomes in patients with CS and severe MR.
Background
Severe mitral regurgitation (MR) in the setting of cardiogenic shock (CS) is associated with three times higher risk of 1-year mortality. In refractory CS, edge-to-edge percutaneous mitral valve repair (PMVR) can be a potential therapeutic option.
Methods
We retrospectively included consecutive patients with refractory CS and concomitant severe MR treated with MitraClip® system. CS was defined according to the criteria used in the SHOCK trial and procedural success according to Mitral Valve Academic Research Consortium (MVARC) criteria. The 30-day and 6-month mortality were the primary and secondary endpoints respectively.
Results
Thirty-one patients (median age 73 years [interquartile range, IQR 66-78], 25.8% female), STS mortality score 37.9 [IQR 30.4-42.4]), with CS and concomitant severe MR treated with edge-to-edge PMVR were retrospectively enrolled. Procedural success was 87.1%. Thirty-day and 6-month survival rates were 78.4 and 45.2% respectively. Univariate Cox Regression Model analysis showed that procedural success was a predictor of both 30-day (HR = 0.12, 95% CI 0.03-0.55, p < .01) and 6-month survival (HR = 0.22, 95% CI 0.06-0.84, p = .027).
Conclusions
Edge-to-edge PMVR in patients with CS and concomitant severe MR was associated with good procedural safety and success with acceptable short and mid-term survival rates. It could be considered a bailout option in this setting of patients.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E163-E170

Percutaneous deep venous arterialization at femoropopliteal segment for unhealed amputated stump ulcer after below the knee amputation.

Ichihashi S, Tamura Y, Maeda S, Kichikawa K
Efficacy of percutaneous deep venous arterialization (pDVA) has been reported for patients with no-option chronic limb threatening ischemia. To date, the procedure has been limited for below the knee/below the ankle occlusive disease. The present report describes the pDVA performed at a femoropopliteal segment for a patient with a stump complication after below the knee amputation. The patient was a 70-year-old male who had a history of endovascular treatment in the right superficial femoral artery (SFA) and below knee amputation 6 years before. He had an unhealed ulcer at the amputated stump for 3 years. Computed tomography angiography demonstrated occluded right SFA, with a stenotic popliteal artery. Revascularization was considered unfeasible due to the absence of run off vessels. In order to improve the perfusion at the ulcer, pDVA was performed at the distal SFA level, bridging SFA and femoral vein using stent grafts. The final angiogram demonstrated the revascularized SFA connecting to popliteal vein with a brisk flow. After pDVA, the stump ulcer improved and the stent grafts were kept patent after 6 months of the procedure. pDVA at the SFA level was technically feasible and could be a useful approach for stump complication after below knee amputation.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E124-E126

Can a self-expanding pediatric stent expand with an artery? Relationship of stent design to vascular biology.

Nia NV, Fishbein GA, Levi DS
Objectives
A large-diameter, intravascular, self-expanding stent system capable of continued expansion during somatic and vascular growth was modeled with finite element analysis (FEA), manufactured and tested in an animal model.
Background
Children can quickly outgrow intravascular stents. If a stent could expand after implantation in arteries this would be ideal for use in pediatric patients.
Methods
Computer-aided design and FEA were used to design and manufacture large-diameter, self-expanding nitinol stents with both high and low chronic outward force (COF). Four distinct stents with similar designs but with variable lengths and strut thicknesses were manufactured. Fourteen of these stents were implanted in the abdominal aortas or iliac arteries of four juvenile swine.
Results
All animals survived without complication to their designated time points of harvest (90 or 180-days), and all stents expanded to greater diameters than the adjacent non-stented artery. Luminal diameter growth was 34-49% and 20-23% for stented and non-stented segments, respectively. Histologic examination revealed variable degrees of the internal elastic lamina and/or medial disruption with a mean injury score ranging from 0.70 ± 0.56 to 1.23 ± 0.21 and low COF stents implanted in smaller arteries having a larger injury score. Inflammatory responses and stenosis formation were minimal and ranged from 0.50 ± 0.71 to 3.00 ± 0.00 and 5.52 ± 1.05% to 14.68 ± 9.12%, respectively. The stent\'s COF did not correlate with vessel expansion or vascular injury.
Conclusions
Self-expanding stents can mirror and even exceed somatic growth. Although longer-term testing is needed, it may be possible to custom tailor self-expanding stents to expand after arterial implantation in pediatric patients.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:139-147

CARotid plaqUe StabilizatiOn and regression with evolocumab: Rationale and design of the CARUSO study.

Aranzulla TC, Piazza S, Ricotti A, Musumeci G, Gaggiano A
Background
While the experience with PCSK9i in patients with coronary artery disease has been wide, and coronary plaque regression has been documented, little is known regarding the role of these drugs on carotid plaque regression. The CARotid plaqUe StabilizatiOn and regression with evolocumab (CARUSO) study is a randomized, single-center, investigator-initiated trial aiming at evaluating carotid plaque morphological stabilization and regression following, respectively, 6 and 12 months of therapy with evolocumab.
Methods
Asymptomatic patients with uni- or bilateral de novo carotid artery stenosis ≥50% and LDL-C values ≥100 mg/dl despite maximum tolerated lipid lowering therapy (LLT) will be randomized to evolocumab 140 mg s.c. every 2 weeks on top of ongoing LLT, or no additional treatment. 100 patients (50 in each arm) will be enrolled. Serial carotid duplex ultra-sonography will be performed to monitor the carotid plaque morphology and stenosis over time.
Results
The primary end point of the study is, (a) carotid plaque morphological stabilization at 6 months, defined as defined as the disappearance of ulcerations and fluffy components and the achievement of a regular plaque morphology with prevalence of fibrous atheroma and/or (b) carotid plaque regression at 12 months, defined as reduction of the entity of the stenosis and/or peak systolic velocity by at least 5%, as compared with baseline.
Conclusion
The CARUSO trial will test the superiority of evolocumab on top of ongoing LLT versus ongoing LLT alone regarding carotid plaque morphological stabilization and regression. The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E115-E121

Correction of sinus venosus atrial septal defects with the 10 zig covered Cheatham-platinum stent - An international registry.

Rosenthal E, Qureshi SA, Jones M, Butera G, ... Vettukattil JJ, Zahn EM
Background
Covered stent correction of sinus venosus ASDs (SVASD) is a relatively new technique. Challenges include anchoring a sufficiently long stent in a nonstenotic superior vena cava (SVC) and expanding the stent at the wider SVC-RA junction without obstructing the anomalous right upper pulmonary vein (RUPV). The 10-zig covered Cheatham-platinum (CCP) stent has the advantage of being available in lengths of 5-11 cm and dilatable to 34 mm in diameter.
Methods
An international registry reviewed the outcomes of 10-zig CCP stents in 75 patients aged 11.4-75.9 years (median 45.4) from March 2016. Additional stents were used to anchor the stent in the SVC or close residual shunts in 33/75. An additional stent was placed in 4/5 (80%) with 5/5.5 cm CCPs, 18/29 (62%) with 6 cm CCPs, 5/18 (28%) with 7 cm CCPs, 5/22 (23%) with 7.5/8 cm CCPs and 0/1 with an 11 cm CCP. A \"protective\" balloon catheter was inflated in the RUPV in 17.
Results
Early stent embolization in two patients required surgical removal and defect repair and tamponade was drained in one patient. The CT at 3 months showed occlusion of the RUPV in one patient. Follow up is from 2 months to 5.1 years (median 1.8 years). QP:QS has reduced from 2.5 ± 0.5 to 1.2 ± 0.36 (p < .001) and RVEDVi from 149.1 ± 35.4 to 95.6 ± 21.43 ml/m2 (p < .001).
Conclusions
Ten-zig CCPs of 7-8 cm appear to provide reliable SVASD closure with a low requirement for additional stents. Careful selection of patients and meticulous attention to detail is required to avoid complications.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:128-136

Preliminary testing and evaluation of the renata minima stent, an infant stent capable of achieving adult dimensions.

Zahn EM, Abbott E, Tailor N, Sathanandam S, Armer D
Objectives
This study sought to obtain in vivo data on a new stent and delivery system specifically designed for implantation in infants with the ability to be enlarged to adult dimensions.
Background
There are no endovascular stents designed for or approved for use in infants, nor is there a stent capable of being implanted at infant vessel diameters and achieving adult size while maintaining structural integrity. The Minima stent was designed to address these needs.
Methods
This study was performed in 6 piglets who underwent implantation of 22 Minima stents into the following locations: aorta (n = 11), branch pulmonary arteries (n = 6), and central veins (n = 5).
Results
Successful deployment occurred in 21/22 attempts. Two instances of post-deployment migration occurred. Stents were re-expanded at 1, 2, 3 and 5 months after implant. All stents regardless of location could be re-dilated to the intended diameter to keep pace with somatic growth (implant diameter 6.9 +/- 1.2 mm; final diameter 16.1 mm +/- 1.4 mm). Histopathology at 1 and 5 months demonstrated widely patent vessel lumens with stent apposition to vessel wall, early mild inflammatory response surrounding stent struts, typical vascular damage and healing response to acute dilation and a progressive smooth neointimal growth covering stent struts over time.
Conclusions
In this in vivo study of the Minima stent, there was high implant success, predictable re-dilatability to adult diameters and favorable histopathology. Further study is warranted.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:117-127

A \"fully upper extremity\" bailout of direct transaxillary large bore arterial access: A refinement within arm\'s reach?

Mathur M, Zack CJ, Heatley A, Rhodes D, ... Gilchrist IC, Kozak M
Contemporary direct (\"fully percutaneous\") transaxillary (TAx) large-bore arterial access technique advocates for a 0.018\" wire to be passed from femoral arterial access to axillary artery to serve percutaneous bailout options. However, in certain patients, avoiding femoral arterial access entirely may be desired. We describe the merits of a \"fully upper extremity\" (FUE) bailout approach, as a refinement to previously described direct TAx technique.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; epub ahead of print

Association of hospital procedural volume with incidence and outcomes of surgical bailout in patients undergoing transcatheter aortic valve replacement.

Isogai T, Saad AM, Michihata N, Ahuja KR, ... Svensson LG, Kapadia SR
Objectives
This study sought to examine the association of hospital procedural volume with the incidence and outcomes of surgical bailout (SB) in patients who undergo transcatheter aortic valve replacement (TAVR).
Background
SB is required for serious complications during or after TAVR. It remains unclear whether hospital experiences affect the incidence and outcomes of SB.
Methods
We retrospectively identified patients who underwent endovascular TAVR using the Nationwide Readmissions Database 2012-2017. We examined the association of annual hospital procedural volume (annual number of endovascular TAVR cases in each hospital in each year) with the incidence and in-hospital mortality of SB using multivariable logistic regressions and restricted cubic splines.
Results
Among 82,764 eligible patients, the incidence of SB was 0.95% (n = 789) and decreased from 2012 to 2017 (from 2.66% to 0.49%; P_trend  < 0.001), while in-hospital mortality of SB remained high over years (from 26.0% to 23.5%; P_trend  = 0.773). Very-high-volume hospitals (≥200 cases/year), as compared with low-volume hospitals (≤49 cases/year), showed significantly a lower incidence of SB (0.49% vs. 1.81%; adjusted OR = 0.28, 95% CI = 0.21-0.38), but similar in-hospital mortality of SB (26.2% vs. 25.6%; adjusted OR = 0.88, 95% CI = 0.47-1.66). There was a significant nonlinear, inverse association of hospital volume with the incidence of SB, but not with the in-hospital mortality of SB.
Conclusions
Hospitals with higher TAVR volumes have a lower risk of SB, but the in-hospital mortality after SB does not change with hospital TAVR volume. Our findings highlight the importance that physicians should always be aware of the high mortality risk of SB following TAVR regardless of hospital procedural experiences.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 28 Jun 2021; epub ahead of print

Predictors of prolonged guidewire manipulation time for native coronary chronic total occlusion percutaneous coronary intervention via primary antegrade approach.

Ochiumi Y, Yamamoto M, Tsuchikane E, Muramatsu T, ... Yoshikawa R, Otsuka T
Objectives
This study aimed to identify the predictive factors for the guidewire manipulation time (GWMT) of ≥20 and 30 min for chronic total occlusion-percutaneous coronary intervention (CTO-PCI) via the primary antegrade approach (PAA).
Background
Selection of primary retrograde approach (PRA) and the optimal timing to switch from antegrade to retrograde approach for coronary CTO-PCI is still debatable.
Methods
Using the Japanese CTO-PCI expert registry data, we selected and analyzed 4461 patients who underwent CTO-PCI via PAA alone. The considerable lesion/anatomical factors for GWMT ≥20 and 30 min were analyzed. The risks of prolonged GWMT ≥20 and 30 min were stratified as easy, intermediate, difficult, and very difficult according to the multivariate analysis.
Results
Nine lesion/anatomical characteristics (blunt stump, side branch at proximal cap, bifurcation at the exit point, calcification, tortuosity, occlusion length ≥ 20 mm, reattempt, nonleft anterior descending artery (nonleft anterior descending artery [LAD]), and tandem CTO) were independent predictors of GWMT ≥20 min (all p < 0.05). Excluding the nonLAD and tandem CTO, the same factors of GWMT ≥20 min correlated with GWMT ≥30 min (all p < 0.05). The distributions were increased in easy, intermediate, difficult, and very difficult subsets of GWMT ≥20 min (58.3%, 77.2%, 89.1%, and 100%) and GWMT ≥30 min (47.5%, 69.2%, 83.9%, and 100%).
Conclusions
These predictive factors of prolonged GWMT should be assessed before CTO-PCI via PAA and when considering an adequate timing to switch the retrograde or PRA if clinically available.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 25 Jun 2021; epub ahead of print

Five-year angiographic, OCT and clinical outcomes of a randomized comparison of everolimus and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds.

Schukraft S, Arroyo D, Togni M, Goy JJ, ... Puricel S, Cook S
Aims
To compare 5-year angiographic, optical coherence tomography (OCT), and clinical outcomes between patients treated with bioresorbable vascular scaffolds (BVS) and drug-eluting stents (DES).
Methods
The EverBio-2 trial (Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold) was a single-center, assessor-blinded, randomized controlled trial in which 240 patients were randomly allocated (1:1:1) to BVS, everolimus-eluting (EES) or biolimus-eluting (BES) DES. Clinical follow-up was scheduled up to 5 years. All patients, alive and who did not have repeat revascularization of the target lesion during follow-up were asked to return for angiographic follow-up at 5 years.
Results
Five-year angiographic follow-up was completed in 122 patients (51%) and OCT analysis was performed in 86 (36%) patients. In-stent late lumen loss was similar in both groups with 0.50 ± 0.38 mm in BVS versus 0.58 ± 0.36 mm in EES/BES, p = 0.20. Clinical follow-up was complete in 232 patients (97%) at 5 years. The rate of the device-oriented endpoint was 22% in the BVS and 18% in the EES/BES group (p = 0.49). The patient-oriented composite endpoint occurred in 40% of BVS- and 43% of EES/BES-treated patients (p = 0.72) at 5 years. No acute coronary syndrome due to stent thrombosis was detected after 2 years. Complete BVS strut resorption was observed at 5 years in the OCT subgroup.
Conclusion
Five-year clinical outcomes were similar between BVS and DES patients as well as angiographic outcomes in a selected subgroup. However, a definitive conclusion cannot be drawn because the EverBio-2 trial was not powered for clinical and angiographic endpoints at 5 years of follow-up.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 25 Jun 2021; epub ahead of print

Procedural planning of CS-based indirect mitral annuloplasty using CT-angiography.

Rottländer D, Gödde M, Degen H, Ögütcü A, Saal M, Haude M
Objectives
Coronary sinus (CS) based mitral annuloplasty using the Carillon device could be limited by compromise of the left circumflex artery (Cx).
Background
Computed tomography (CT) might be a feasible tool for preprocedural planning of indirect mitral valve annuloplasty.
Methods
In a retrospective analysis, 25 patients underwent Carillon device implantation and received CT-angiography (CTA) analysis prior to CS based percutaneous mitral valve repair. We used a retrospective approach with preprocedural CTA and intraprocedural coronary sinus angiography (CSA) measurements to determine the CS to Cx distance at the occlusion or compression point or in the distal landing zone in absence of Cx compromise.
Results
According to left coronary artery angiography, we identified 7 patients with Cx occlusion, 7 with Cx compression and 11 without Cx compromise. No difference in minimal CS to Cx distance between the three groups could be obtained. Also, neither distal CS diameter nor distal Carillon anchor size were related to Cx impingement. However, ROC analysis identified a CS to Cx distance of <8.6 mm specifically in the distal device landing zone to predict Cx compromise. Furthermore, CTA was accurate in assessing device length in comparison to CSA, but failed predicting Carillon device anchor size.
Conclusions
CTA derived CS to Cx distance in the device landing zone might be helpful to predict Cx occlusion during Carillon device implantation. Furthermore, CTA predicted CS length but not anchor size correctly. Therefore, CT-angiographic procedural planning might help improving the results of percutaneous CS-based mitral valve repair.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 24 Jun 2021; epub ahead of print

Very late vasomotor responses and gene expression with bioresorbable scaffolds and metallic drug-eluting stents.

Koh JS, Gogas BD, Kumar S, Benham JJ, ... Jo H, Samady H
Objectives
To investigate the long-term vasomotor response and inflammatory changes in Absorb bioresorbable vascular scaffold (BVS) and metallic drug-eluting stent (DES) implanted artery.
Background
Clinical evidence has demonstrated that compared to DES, BVS is associated with higher rates of target lesion failure. However, it is not known whether the higher event rates observed with BVS are related to endothelial dysfunction or inflammation associated with polymer degradation.
Methods
Ten Absorb BVS and six Xience V DES were randomly implanted in the main coronaries of six nonatherosclerotic swine. At 4-years, vasomotor response was evaluated in vivo by quantitative coronary angiography response to intracoronary infusion of Ach and ex vivo by the biomechanical response to prostaglandin F2-α (PGF2-α), substance P and bradykinin and gene expression analysis.
Results
Absorb BVS implanted arteries showed significantly restored vasoconstrictive responses after Ach compared to in-stent Xience V. The contractility of Absorb BVS treated segments induced by PGF2-α was significantly greater compared to Xience V treated segments and endothelial-dependent vasorelaxation was greater with Absorb BVS compared to Xience V. Gene expression analyses indicated the pro-inflammatory lymphotoxin-beta receptor (LTβR) signaling pathway was significantly upregulated in arteries treated with a metallic stent compared to Absorb BVS treated arterial segments.
Conclusions
At 4 years, arteries treated with Absorb BVS compared with Xience V, demonstrate significantly greater restoration of vasomotor responses. Genetic analysis suggests mechanobiologic reparation of Absorb BVS treated arteries at 4 years as opposed to Xience V treated vessels.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 23 Jun 2021; epub ahead of print

In-hospital outcomes of endovascular versus surgical revascularization for chronic total occlusion in peripheral artery disease.

Zghouzi M, Moussa Pacha H, Ullah W, Sattar Y, ... Mamas MA, Alraies MC
Background
The outcome of endovascular intervention (EVI) compared vs. surgical revascularization in patients with peripheral artery disease (PAD) due to chronic total occlusion (CTO) is unknown.
Methods
Using the National Inpatient Sample database between 2007 and 2014, we identified all PAD patients with CTO who had limb revascularization. Multivariate analysis was performed to estimate the odds of in-hospital mortality and adverse outcomes between both groups.
Results
A total of 168,420 patients who had peripheral CTO and underwent limb revascularization were identified. 99,279 underwent EVI, and 69,141 underwent surgical revascularization. The patients who underwent EVI were younger, more likely to be women and African American, and less likely to be white (p < 0.001 for all). EVI was associated with lower in-hospital mortality (1.2% vs 1.7%, adjusted odds ratio [aOR]: 0.54; 95% confidence interval [CI] 0.50-0.59). The EVI group had higher vascular complications, major bleeding, acute kidney injury (AKI), and major amputation compared with surgical revascularization. A subgroup analysis on patients with critical limb ischemia showed lower mortality in the EVI group (1.4% vs. 1.9, aOR 0.56; 95% CI 0.50-0.63). Although there was no difference in the incidence of AKI or major amputation between the two groups, the EVI group had higher vascular complication rates and major bleeding events.
Conclusion
EVI in PAD with CTO is associated with lower in-hospital mortality, likely due to the procedure\'s less-invasive nature; however, it is associated with higher postprocedural complications likely due to the CTO\'s complexity.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 22 Jun 2021; epub ahead of print

Outcomes of mechanical circulatory support for acute myocardial infarction complicated by cardiogenic shock.

Kim Y, Shapero K, Ahn SS, Goldsweig AM, Desai N, Altin SE
Background
Mechanical circulatory support (MCS) with the Impella device (Abiomed, Danvers, MA) has been associated with higher in-hospital mortality than intra-aortic balloon pump (IABP) in the Premier Healthcare Database and National Cardiovascular Data Registry.
Methods
The objective of this retrospective cohort study was to describe trends and outcomes of Impella usage in acute myocardial infarction complicated by cardiogenic shock (AMICS) treated with MCS (Impella or IABP) using real-world observational data from the National Inpatient Sample (NIS) including hospitalizations for AMICS managed with MCS between January 2012 to December 2017. The primary outcomes included in-hospital mortality, transfusion, acute kidney injury, stroke, total costs, and length of stay. Propensity score matching was performed with hierarchical models using risk factor and Elixhauser comorbidity variables.
Results and conclusion
We identified 54,480 hospitalizations for AMICS managed with MCS including 5750 (10.5%) utilizing Impella. Throughout the study period, Impella usage increased yearly to 19.9% of AMICS cases in 2017. After propensity score matching, Impella was associated with higher in-hospital mortality (odds ratio [OR] 1.74, 95% confidence interval [CI] 1.41-2.13) and transfusions (OR 1.97, 95% CI 1.40-2.78) than IABP, without association with acute kidney injury or stroke. Impella use was associated with higher hospital costs (mean difference $22,416.80 [95% CI $17,029-27,804]). Impella usage for AMICS increased significantly from 2012 to 2017 and was associated with increased in-hospital mortality and costs. Randomized controlled trials are urgently needed to assess the safety and efficacy of Impella.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 21 Jun 2021; epub ahead of print

Acute stroke intervention for acute embolic procedural strokes performed by cardiologists.

Piayda K, Grunwald I, Sievert K, Bertog S, Sievert H
Acute ischemic stroke is a feared complication during cardiovascular procedures associated with high morbidity and mortality if not immediately recognized and treated. We conducted a review of cases at our center where patients experienced an acute, procedure-related ischemic stroke and underwent immediate endovascular stroke treatment by the interventional cardiologists trained in acute endovascular stroke intervention. Baseline demographics, procedural and follow-up data were collected. Three patients were identified in whom the percutaneous procedure (peripheral arterial intervention, transapical NeoChord [NeoChord Inc, Minnesota, USA] implantation and transcatheter aortic valve implantation, respectively) was complicated by an acute embolic ischemic stroke. In all cases, cerebral vessel re-canalization was technically successful with thrombolysis in cerebral infarction (TICI) IIB/III flow. Follow-up computed tomography scans showed no infarct demarcation, oedema or intracranial hemorrhage. One patient survived with no neurological symptoms at 6-month follow-up whereas the two other patients died of unrelated intensive care complications and decompensated heart failure. We conclude that endovascular stroke treatment during cardiovascular interventions can be performed by interventional cardiologists with appropriate training. It offers the unique opportunity to treat cerebral embolization in a time-efficient manner, potentially improving morbidity and mortality of affected patients.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 21 Jun 2021; epub ahead of print

Long-term outcomes after deferral of revascularization of in-stent restenosis using fractional flow reserve.

McInerney A, Travieso Gonzalez A, Castro Mejía A, Tirado-Conte G, ... Escaned J, Gonzalo N
Objectives
To investigate the outcomes of deferred coronary revascularization in patients with non-significant in-stent restenosis (ISR) by physiological assessment.
Background
The pathophysiology and natural history of ISR is markedly different from de-novo stenoses. There is a paucity of data on the safety of deferral of revascularization of ISR using physiological assessment.
Methods
In this single centre study, using a propensity-score matched analysis, we compared the long-term clinical outcomes of patients with ISR and de-novo disease deferred based on intracoronary physiology. Matching was on a 1:2 basis of ISR to de-novo stenosis. The primary end point was major adverse cardiovascular events (MACE) a composite of all-cause mortality, target lesion revascularization or target vessel myocardial infarction at 36 months.
Results
Matched cohorts of 56 ISR and 112 de-novo stenoses were analyzed. The median percentage stenosis was 50% in both groups (p = 0.403). Deferral was based on fractional flow reserve (FFR). The mean FFR was 0.86 across both groups (p = 0.942). At 36-months, freedom from MACE was similar between groups; 86.2% versus 92.8% log rank p=0.180 for ISR and de-novo lesions, respectively. Neither were there differences in the individual components of MACE.
Conclusions
Deferral of coronary revascularization in patients with ISR based on its functional impact is associated to similar long-term safety as in de-novo coronary stenosis.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 21 Jun 2021; epub ahead of print

Percutaneous closure of a patent foramen ovale causing exercise hypoxemia: Case report and a review of the literature.

Punzengruber G, Kolb R, Meier B, Binder RK
Provoked exercise desaturation is a rare presentation of patent foramen ovale (PFO), when vigorous exercise leads to desaturation of arterial blood and subsequent dyspnea. We present a case of provoked exercise desaturation and curative percutaneous closure and review the literature. A 54-year-old male patient presented with shortness of breath during exercise in the pneumology outpatient department. During exercise spirometry, a relevant drop in arterial oxygen saturation and partial pressure of oxygen was observed and a right-left shunt suspected. In a transesophageal echocardiogram, a PFO was observed. Cardiac catheterization documented a right-left-shunt causing desaturation during exercise. Following percutaneous closure of the PFO, exercise induced desaturation was no longer detectable during exercise spirometry and there was considerable improvement in exercise capacity and subjective dyspnea. To sum up, provoked exercise desaturation is a rare but curable presentation of PFO. Percutaneous closure is a safe and effective way to treat this entity.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 18 Jun 2021; epub ahead of print

Use and outcomes of cerebral embolic protection for transcatheter aortic valve replacement: A US nationwide study.

Khan MZ, Zahid S, Khan MU, Kichloo A, ... Goldsweig AM, Balla S
Background
Outcomes data on the use of cerebral embolic protection devices (CPDs) with transcatheter aortic valve replacement (TAVR) remain limited. Previous randomized trials were underpowered for primary outcomes of stroke prevention and mortality.
Methods
The National Inpatient Sample and Nationwide Readmissions Database were queried from 2017 to 2018 to study utilization and inpatient mortality, neurological complications (ischemic stroke, hemorrhagic stroke, and transient ischemic attack), procedural complications, resource utilization, and 30-day readmissions with and without use of CPD. A 1:3 ratio propensity score matched model was created.
Results
Among 108,315 weighted encounters, CPD was used in 4380 patients (4.0%). Adjusted mortality was lower in patients undergoing TAVR with CPD (1.3% vs. 0.5%, p < 0.01). Neurological complications (2.5% vs. 1.7%, p < 0.01), hemorrhagic stroke (0.2% vs. 0%, p < 0.01) and ischemic stroke (2.2% vs. 1.4%, p < 0.01) were also lower in TAVR with CPD. Multiple logistic regression showed CPD use was associated with lower adjusted mortality (odds ratio (OR], 0.34 [95% confidence interval [CI], 0.22-0.52), p < 0.01) and lower adjusted neurological complications (OR, 0.68 (95% CI, 0.54-0.85], p < 0.01). On adjusted analysis, 30-day all-cause readmissions (Hazard ratio, HR 0.839, [95% CI, 0.773-0.911], p < 0.01) and stroke (HR, 0.727 [95% CI, 0.554-0.955), p = 0.02) were less likely in TAVR with CPD.
Conclusion
We report real-world data on utilization and in-hospital outcomes of CPD use in TAVR. CPD use is associated with lower inpatient mortality, neurological, and clinical complications as compared to TAVR without CPD.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 18 Jun 2021; epub ahead of print

Frailty, malnutrition, and the endocrine system impact outcome in patients undergoing aortic valve replacement.

Al-Kassou B, Shamekhi J, Weber M, Germeroth J, ... Nickenig G, Sinning JM
Background
Frailty is a multidimensional syndrome that affects mortality after aortic valve replacement (AVR). Malnutrition is often associated with the development of frailty. However, data regarding the association of frailty with nutritional status and underlying endocrinological dysregulation in patients with severe aortic valve stenosis are limited.
Objectives
We aimed to systematically screen for frailty and malnutrition, to evaluate for underlying endocrinological disorders and inflammation, and to assess the ability of these parameters to predict outcomes after AVR.
Methods
Our study included 373 patients undergoing transcatheter and surgical AVR. Frailty was assessed using the Fried Frailty Phenotype (FFP), Essential Frailty Toolset, Lawton-Brody, and Katz Index. Malnutrition was measured using the Mini Nutritional Assessment (MNA-LF) and Controlling Nutritional Status. Outcomes of interest were 30-day and one-year mortality.
Results
The prevalence of frailty ranged from 6.4% to 65.7% and malnutrition from 5.9% to 10.5%, depending on the evaluation tool. Both parameters were associated with higher levels of cortisol and parathormone as well as lower levels of IGF-1, testosterone, DHEAS, and c-reactive protein. Malnutrition was associated with increased 30-day mortality, and both frailty and malnutrition with increased one-year mortality. In a multivariate analysis, malnutrition measured by the MNA-LF (OR: 2.32 [95%CI: 1.19-4.53], p = 0.01) and frailty as assessed by the FFP (OR: 1.42 [95%CI: 1.02-1.96], p = 0.03) were independent predictors of one-year mortality.
Conclusion
The prevalence of frailty and malnutrition varies significantly depending on the assessment tool. Both syndromes share common endocrinological alterations. Frailty and malnutrition are independent risk factors for mortality after AVR.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 17 Jun 2021; epub ahead of print

Role of tenecteplase (rtPA) to re-establish flow in intraprocedural stent thrombosis in infants undergoing ductal stenting for duct-dependent pulmonary circulation-a case series.

Tan JWY, Alwi M, Siew ELL, Samion H
Ductal stenting in patients with duct-dependent pulmonary circulation has allowed growth of pulmonary arteries prior to definitive surgical procedures. Intraprocedural stent thrombosis (IPST) of the arterial duct is a life-threatening complication as it leads to total circulatory collapse. Previous reports have described use of tissue plasminogen activators in infants for less emergent settings. We report three infants with IPST and the use of tenecteplase to overcome this. Also discussed are the predisposing mechanisms in each scenario and a possibility of direct catheter-guided tenecteplase administration. Judicious use of tenecteplase can be life-saving and rapid access to this drug may obviate the need for emergency extracorporeal life support.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 17 Jun 2021; epub ahead of print

Predictors of scaffold failure and impact of optimized scaffold implantation technique on outcome: Results from the German-Austrian ABSORB RegIstRy.

Boeder NF, Kastner J, Mehilli J, Münzel T, ... Nef HM, GABI-R Study Group
Aims
We aimed to investigate predictors of scaffold failure and the potential impact of an optimized scaffold implantation technique by means of a learning curve on long-term clinical outcome after bioresorbable scaffold (BRS) implantation and to evaluate predictors of scaffold failure.
Methods and results
A total of 3326 patients were included in this prospective, observational, multi-center study (ClinicalTrials.gov NCT02066623) of consecutive patients undergoing BRS implantation between November 2013 and January 2016. The 3144 patients completed follow-up after 24 months, 3265 patients were eligible for time-to-event-analysis. Clinical endpoints were major adverse cardiac events-a composite endpoint of death, target vessel revascularization and myocardial infarction, and scaffold thrombosis (ScT). Patients were grouped according to treatment before or since 2015. During follow-up MACE rate improved from 2.52% after 30 days, 5.45% after 6 months and 12.67% after 24 months to 1.52%, 3.44%, and 10.52%, respectively. A total of 75 ScT occurred. In multiple regression analysis, treatment of bifurcations, long lesions, and procedures performed earlier than 2014 were identified as predictors for the occurrence of ScT.
Conclusion
Treatment of bifurcation lesions is the strongest predictor of ScT following BRS implantation. A significantly lower incidence of ScT and 24-month target lesion revascularization in patients recruited after 2014 into our observational registry suggests the influence of a learning curve.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 17 Jun 2021; epub ahead of print

Prognostic impact of echocardiographic mean transvalvular gradients in patients with aortic stenosis and low flow undergoing transcatheter aortic valve implantation.

Fischer-Rasokat U, Renker M, Liebetrau C, Weferling M, ... Hamm CW, Kim WK
Background
Blunted left ventricular hemodynamics reflected by a low stroke volume index (SVI) ≤35 mL/m² body surface area (low flow [LF]) in patients with severe aortic stenosis (AS) are associated with worse outcomes even after correction of afterload by transcatheter aortic valve implantation (TAVI). These patients can have a low or high transvalvular mean pressure gradient (MPG). We investigated the impact of the pre-interventional MPG on outcomes after TAVI.
Methods
Patients with LF AS were classified into those with normal (EF ≥ 50%; LF/NEF) or reduced ejection fraction (EF < 50%; LF/REF) and were then stratified according to an MPG < or ≥ 40 mmHg. Patients with SVI >35 mL/m² (normal flow; NF) served as controls.
Results
597 patients with LF/NEF, 264 patients with LF/REF and 975 patients with NF were identified. Among all groups those patients with a low MPG were characterized by higher cardiovascular risk. In patients with LF/REF, functional improvement post-TAVI was less pronounced in low-MPG patients. One-year survival was significantly worse in LF AS patients with a low vs. high MPG (LF/NEF 16.5% vs. 10.5%, p = 0.022; LF/REF 25.4% vs. 8.0%, p = 0.002), whereas no differences were found in NF patients (8.7% vs. 10.0%, p = 0.550). In both LF AS groups, a low pre-procedural MPG emerged as an independent predictor of mortality.
Conclusions
In patients with LF AS, an MPG cut-off of 40 mmHg defines two patient populations with fundamental differences in outcomes after TAVI. Patients with LF AS and a high MPG have the same favorable prognosis as patients with NF AS.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 16 Jun 2021; epub ahead of print

Percutaneous artErial closure devices and ultrasound-guided Trans-femoRal puncture ObservatioNal InvestigatiOn: Insights from the PETRONIO registry.

Iannopollo G, Nobile G, Lanzilotti V, Capecchi A, ... Di Pasquale G, Casella G
Objective
To evaluate the safety of a single and combined use of ultrasound-guided femoral puncture (U) and percutaneous arterial closure devices (P) in femoral artery procedures (FAP) compared to fluoroscopic guidance (F) and manual compression (M) in a large radial-focused interventional centre.
Background
U and P, taken individually, have improved safety in femoral arterial access procedures compared to traditional techniques.
Methods
All FAP performed between July 2017 and December 2018 in our centre were divided into three phases: (a) control period with F and M mainly performed; (b) phase out period where U and P were introduced; (c) intervention period where a 6-month expertise on the novel techniques was acquired. The overall population was further stratified into subgroups: F/M, U/M, F/P, U/P. The primary study endpoint was in-hospital access site bleeding events (BE) according to the BARC criteria. The secondary endpoint was vascular site complications (VASC).
Results
Four hundred eighteen procedures (14%) out of 3025 were performed via FA access during the study period. The overall access-site in-hospital BE were 97 (23%). Decreasing rates of BE (phase 1: n = 46, 29%; phase 2: n = 38, 22% e phase 3: n = 13, 15%; p = 0.027) and VASC were observed during the three periods. BE occurred significantly more often in F/M group (F/M: n = 48; 32%; U/M: n = 12, 16%; F/P: n = 18, 21%; U/P: n = 19, 17%; p = 0.008). F/M subgroup was an independent predictor of BE both in multivariable analysis and propensity score matching analysis.
Conclusions
The introduction of ultrasound-guided femoral puncture and percutaneous arterial closure devices has reduced access site bleedings with a progressive improvement after the first 6 months learning period.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 16 Jun 2021; epub ahead of print

Safety and usefulness of a novel short track sliding balloon catheter.

Chung YH, Kim JS, Lee SY, Im E, ... Hong MK, Jang Y
Objectives
To evaluate the safety and technical utility of the short track sliding (STS) balloon catheter.
Background
An STS balloon catheter is designed to ensure a low profile at the shaft and perform distal anchoring using a single guidewire. However, its clinical practice with the STS balloon catheter has not been reported.
Methods
This prospective multi-center registry enrolled 100 patients with significant coronary artery disease who had undergone percutaneous coronary intervention using an STS balloon catheter at three hospitals in Korea from March 2019 to July 2020. Overall safety was assessed as any occurrences of device-related malfunction during the pre-dilation of the lesions. Its technical success rates of the kissing balloon technique or the distal anchoring technique using a single guidewire were also evaluated.
Results
Of the 118 lesions pre-dilated using the STS balloon, no significant complication was observed except for three significant coronary dissections, which were completely covered with stents. There was no incidence of balloon catheter malfunction, such as fracture, entrapment, or perforation. With 13 attempts of kissing ballooning techniques with the STS balloon with a 6F guiding catheter, all cases were successful. The distal anchoring techniques were attempted in 10 cases, the stent was successfully crossed to the target lesion in all 10 cases.
Conclusions
The novel STS balloon catheter can be safely applied in routine coronary intervention with minimal complications. In addition, this catheter could be useful for performing the kissing balloon technique with a small-caliber guiding catheter and distal anchoring technique with a single guidewire.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 16 Jun 2021; epub ahead of print

The Allegra transcatheter heart valve: Short term results from a multicenter registry.

Wolfrum M, Moccetti F, Piuhola J, Lehtola H, ... Niemelä M, Toggweiler S
Objectives
We aimed to determine the safety and efficacy of the Allegra transcatheter heart valve (THV) for the treatment of severe aortic valve stenosis in a large patient population treated under real-world conditions.
Background
The Allegra is a novel self-expanding THV with supra-annular bovine leaflets. The valve is available in three different sizes (23, 27, and 31 mm), all are delivered through an 18F sheath.
Methods
Consecutive patients undergoing TAVR with the Allegra THV were enrolled in a multicenter-registry. Data were collected throughout initial hospital-stay and at 30-day follow-up. Clinical endpoints were defined according to the updated definitions of the Valve-Academic-Research-Consortium.
Results
This registry included 255 patients (mean age 83 ± 6 years, 48% women) from four European centers. Median European System for Cardiac Operative Risk Evaluation II score (EuroSCORE II) was 3.3% (IQR 1.9-5.8%). Acute device success was 95.7%. The remaining 11 patients had either moderate paravalvular regurgitation immediately after the procedure (7 patients) or the device could not be optimal positioned requiring implantation of a second THV (4 patients). Major vascular complications and major/life-threatening bleedings occurred in 10 (3.9%) and 12 (4.7%) patients, respectively. At 30 day follow-up, mean effective orifice area was 2.2 ± 0.5 cm² , mean gradient was 6.9 ± 3.8 mmHg, 7 (3.3%) patients had more than mild paravalvular leakage, 3 patients (1.2%) had died, 6 patients (2.4%) had a stroke and 30 (12.8%) patients had required implantation of a new permanent pacemaker.
Conclusions
Transfemoral implantation of the Allegra THV resulted in favorable clinical and echocardiographic outcomes during hospitalization and short-term follow up.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 16 Jun 2021; epub ahead of print

Everolimus eluting bioresorbable vascular scaffolds in patients with acute coronary syndromes: Two-year results from the German-Austrian ABSORB registry.

Tröbs M, Achenbach S, Nef HM, Gori T, ... Hamm CW, GABI-R Study Group
Objectives
To identify potential differences in 2-year outcome between patients who underwent coronary revascularization using bioresorbable vascular scafffolds (BVS) in stable coronary artery disease (CAD) and acute coronary syndromes (ACS).
Background
Data from randomized trials suggest a significantly higher event rate following coronary revascularization using everolimus-eluting BVS as compared to new generation drug eluting stents. Whether particular patient subgroups are at increased risk for scaffold thrombosis and target lesion failure (TLF) has not clearly been demonstrated.
Methods
German-Austrian ABSORB RegIstRy is a prospective all-comer multi-center observational study of consecutive patients who were considered for coronary revascularization with BVS. We compared 1499 patients with stable CAD to 1594 patients with ACS. Endpoints were major adverse cardiac events (MACE), TLF, and scaffold thrombosis.
Results
While single vessel disease was more prevalent in ACS (46% vs. 37%, p < 0.0001), lesion complexity (B2/C stenosis 37% vs. 36%, bifurcation 2.4% vs. 3.4%, p < 0.05), number of implanted scaffolds/patient (1.34 vs. 1.43), scaffold length (18 vs. 18 mm) or the rate of high pressure postdilatation (68% vs. 70%) did not differ between ACS and stable CAD. Two-year MACE rates were 11.6% in ACS and 11.4% in stable CAD, TLF occurred in 7.0% versus 7.4% and target vessel revascularization in 8.8 versus 10.2% (n.s. for all). Definite scaffold thrombosis rates were not significantly different (ACS 1.9% vs. stable CAD 2.1%).
Conclusion
Real-world 2-year event rates after coronary revascularization with BVS are not significantly different between individuals with ACS as compared to stable CAD.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 16 Jun 2021; epub ahead of print

Efficacy and safety of percutaneous patent foramen ovale closure in patients with a hypercoagulable disorder.

Ben-Assa E, Herrero-Garibi J, Cruz-Gonzalez I, Elmariah S, ... Inglessis I, Palacios IF
Background
Transcatheter closure of patent foramen ovale (PFO) in patients with cryptogenic stroke reduces the rate of recurrent events. Although presence of thrombophilia increases the risk for paradoxical emboli through a PFO, such patients were excluded from large randomized trials.
Objectives
We compared the safety and efficacy of percutaneous PFO closure in patients with and without a hypercoagulable state.
Methods
Data from 800 consecutive patients undergoing percutaneous PFO closure in our medical center were analyzed. All patients were independently evaluated by specialists in neurology, cardiology, hematology, and vascular medicine. A post-procedural treatment of at least 3 months of anticoagulation was utilized in patients with thrombophilia. Follow-up events included death, recurrent neurological events, and the need for reintervention for significant residual shunt.
Results
A hypercoagulable state was found in 239 patients (29.9%). At median follow-up of 41.9 months, there were no differences in the frequencies of stroke or transient ischemic attack between patients with or without thrombophilia (2.5% in non-hypercoagulable group vs. 3.4% in hypercoagulable group, log-rank test p = 0.35). There were no significant differences in baseline demographics, echocardiographic characteristics, procedural success, or complications between groups.
Conclusion
Percutaneous PFO closure is a safe and effective therapeutic approach for patients with cryptogenic stroke and an underlying hypercoagulable state.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 15 Jun 2021; epub ahead of print

Real-time intravascular ultrasound guidance: A novel technique for accurate placement of ostial stents.

Harding SA, Webber B, Fairley S, Ormiston JA
Objectives
To describe a novel technique for ostial stent placement using real-time IVUS guidance.
Background
Accurate placement of coronary stents at ostial locations is challenging with the true ostium frequently being missed increasing the risk of adverse events. We have developed a novel technique for ostial stent placement and report our benchtop testing and initial clinical experience.
Methods
Benchtop testing was performed to validate the appearance of the stent and delivery system on IVUS. Benchtop testing of real-time IVUS guided ostial stent positioning was carried out in a left main bifurcation phantom. Real-time IVUS guidance of stent placement in aorto-ostial, ostial left anterior descending (LAD), or ostial circumflex lesions was assessed in a prospective registry.
Results
Bench model IVUS demonstrated clear differences between the appearances of the stent and other components of the delivery system. Positioning of 10 consecutive stents into the ostial LAD using real-time IVUS guidance was assessed in a left main bifurcation model. Median distance from proximal stent edge to LAD ostium was 0.39 mm (interquartile range 0.31 to 0.73). Real-time IVUS guidance of ostial stent placement was performed in 50 patients (51 lesions). Angiographic success was 100%. IVUS post-stenting demonstrated median distance from the proximal stent edge to the ostium was 0.2 mm (interquartile range 0.1 to 0.5 mm). There was one periprocedural myocardial infarction but no other major adverse cardiac events at 30-days.
Conclusions
We have developed a novel technique using real-time IVUS guidance allowing accurate ostial stent placement.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 15 Jun 2021; epub ahead of print

Improvement of symptoms and coronary perfusion gradient with mechanical left ventricular unloading in flow-limiting complex spontaneous coronary artery dissection, without revascularization.

Tarantini G, Fabris T, Rodinò G, Fraccaro C
Spontaneous coronary artery dissection (SCAD) can lead to acute coronary syndrome and sudden cardiac death, particularly in young women. Observational data show that, in SCAD patients, both percutaneous coronary intervention and coronary artery bypass grafting seem to be hampered by higher technical complexity, lower success rates, and worse outcomes. As spontaneous healing is a common occurrence, expert consensus advices medical management of the acute phase, when feasible. We present the case of a young woman with SCAD of left anterior descending artery causing myocardial infarction with ST-segment elevation. High-anatomical complexity and unstable conditions of the patient made both medical management and immediate revascularization unfeasible options. Therefore, we decided to implant a percutaneous off-loading mechanical support device to improve coronary perfusion pressure by unloading the left ventricle and preserve cardiac function, preventing worse complications of acute myocardial infarction. This strategy was successful in stabilizing the patient, until the definitive revascularization treatment became an option.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Jun 2021; epub ahead of print

Tricuspid clip implantation using the MitraClip system-A step-by-step guide.

Kaple RK, Agarwal V, Azarbal A, Sugeng L, Tang GHL
Many novel percutaneous interventions are being developed for application in the tricuspid valve position. At the present time, there are no commercially available devices for this application. There has been mounting evidence supporting the safety and efficacy of using the MitraClip system on the tricuspid valve. This review summarizes the peer reviewed data available to date supporting this procedure, outlines the step-by-step maneuvers using the MitraClip system for this application, and imaging techniques used prior to and during the procedure.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 13 Jun 2021; epub ahead of print

Incidence, predictors and clinical impact of permanent pacemaker insertion in women following transcatheter aortic valve implantation: Insights from a prospective multinational registry.

Nicolas J, Guedeney P, Claessen BE, Mehilli J, ... Chieffo A, Mehran R
Objectives
To describe the incidence, predictors, and clinical impact of permanent pacemaker insertion (PPI) following transcatheter aortic valve replacement (TAVR) in women.
Background
Data on pacemaker insertion complicating TAVR in women are scarce.
Methods
The Women\'s International Transcatheter Aortic Valve implantation (WIN-TAVI) is a prospective registry evaluating the safety and efficacy of TAVR in women. We included patients without preprocedural pacemakers and divided them into two groups: (1) PPI and (2) no-PPI. We identified PPI predictors using logistic regression and studied its clinical impact on the Valve Academic Research Consortium (VARC)-2 efficacy and safety endpoints.
Results
Out of 1019 patients, 922 were included in the analysis. Post-TAVR PPI occurred in 132 (14.3%) patients. Clinical and procedural characteristics were similar in both groups. Pre-existing right bundle branch block (RBBB) was associated with a high risk of post-TAVR PPI (OR 3.62, 95% CI 1.85-7.06, p < 0.001), while implantation of balloon-expandable prosthesis was associated with a lower risk (OR 0.47, 95% CI 0.30-0.74, p < 0.001). Post-TAVR PPI prolonged in-hospital stay by a median of 2 days (11 [9-16] days in PPI vs. 9 [7-14] days in no-PPI, p = 0.005), yet risks of VARC-2 efficacy and safety endpoints at 1 year were similar in both groups (_adj HR 0.95, 95% CI 0.60-1.52, p = 0.84 and _adj HR 1.22, 95% CI 0.83-1.79, p = 0.31, respectively).
Conclusion
Pacemaker implantation following TAVR is frequent among women and is associated with pre-existing RBBB and valve type. PPI prolongs hospital stay, albeit without any significant impact on 1-year outcomes.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 11 Jun 2021; epub ahead of print

Meta-analysis comparing valve-in-valve TAVR and redo-SAVR in patients with degenerated bioprosthetic aortic valve.

Saleem S, Ullah W, Syed MA, Megaly M, ... Abdul-Waheed M, Fischman DL
Introduction
The comparative efficacy and safety of valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) and redo-surgical AVR (redo-SAVR) in patients with degenerated bioprosthetic aortic valves remain unknown.
Method
Digital databases were searched to identify relevant articles. Unadjusted odds ratios for dichotomous outcomes were calculated using a random effect model. A total of 11 studies comprising 8326 patients (ViV-TAVR = 4083 and redo-SAVR = 4243) were included.
Results
The mean age of patients undergoing ViV-TAVR was older, 76 years compared to 73 years for those undergoing SAVR. The baseline characteristics for patients in ViV-TAVR vs. redo-SAVR groups were comparable. At 30-days, the odds of all-cause mortality (OR 0.45, 95% CI 0.30-0.68, p = .0002), cardiovascular mortality (OR 0.44, 95% CI 0.26-0.73, p = .001) and major bleeding (OR 0.29, 95% CI 0.15-0.54, p = .0001) were significantly lower in patients undergoing ViV-TAVR compared to redo-SAVR. There were no significant differences in the odds of cerebrovascular accidents (OR 0.91, 95% CI 0.52-1.58, p = .74), myocardial infarction (OR 0.92, 95% CI 0.44-1.92, p = .83) and permanent pacemaker implantation (PPM) (OR 0.54, 95% CI 0.27-1.07, p = .08) between the two groups. During mid to long-term follow up (6-months to 5-years), there were no significant differences between ViV-TAVR and redo-SAVR for all-cause mortality, cardiovascular mortality and stroke. ViV-TAVR was, however, associated with higher risk of prosthesis-patient mismatch and greater transvalvular pressure gradient post-implantation.
Conclusion
ViV-TAVR compared to redo-SAVR appears to be associated with significant improvement in short term mortality and major bleeding. For mid to long-term follow up, the outcomes were similar for both groups.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 09 Jun 2021; epub ahead of print

Cutting balloon angioplasty on branch pulmonary artery stenosis in pediatric patients.

Cobb H, Spray B, Daily J, Dossey A, Angtuaco MJ
Objectives
To identify medium-term results following cutting balloon angioplasty (CBA) for branch pulmonary artery stenosis (PAS) and predictors of successful intervention.
Background
CBA has emerged as a successful alternative therapy for PAS resistant to conventional balloon angioplasty techniques but there is little information on medium and long-term outcomes.
Methods
This is a descriptive, single center, retrospective chart review of pediatric patients who underwent CBA for PAS at Arkansas Children\'s Hospital between May 2005 and December 2020. We reviewed demographics, procedural specifics, and 30-day complications.
Results
Forty-four patients underwent pulmonary artery CBA on 114 pulmonary artery segments through 126 catheterization cases, totaling 148 CBA events. Thirty-three individual pulmonary arteries underwent repeat intervention. Average minimal luminal diameter increase from pre-CBA to end of follow-up was 57% (CI, 38%-75%). Absence of Tetralogy of Fallot with pulmonary atresia and major aortopulmonary collateral arteries (TOF/PA/MAPCAs) and the absence of Alagille Syndrome, Williams Syndrome, or Arterial Tortuosity Syndrome (ATS) were associated with increased odds of sustained success by 70% (CI, 0.11-0.79) and 91% (CI, 0.02-0.56), respectively. Increasing the cutting balloon diameter-to-minimal luminal diameter ratio by 0.5 increased odds of successful intervention by 2.37-fold (CI, 1.7-3.3). Seven patients had 30-day complications including one death.
Conclusions
In the longest follow-up to date of children and adolescents who underwent CBA for branch PAS, we found that there was moderate medium-term success. Additionally, absence of TOF/PA/MAPCAs, absence of Alagille Syndrome, Williams Syndrome, or ATS, and high cutting balloon diameter-to-minimal luminal diameter ratio are predictors of sustained results.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 09 Jun 2021; epub ahead of print

Short- and mid-term outcomes in percutaneous mitral valve replacement using balloon expandable valves.

Eng MH, Kargoli F, Wang DD, Frisoli TM, ... Wyman J, O\'Neill W
Background
Due to elevated surgical risk, transcatheter mitral valve replacement (TMVR) is used as an alternative for treating failed bioprosthetic valves, annuloplasty repairs and mitral annular calcification (MAC). We report the procedural and longitudinal outcomes for each subtype: Mitral valve-in-valve (MVIV), mitral valve-in-ring (MViR), and valve-in-MAC (ViMAC).
Methods
Consecutive patients undergoing TMVR from October 2013 to December 2019 were assessed. Patients at high risk for left ventricular outflow tract obstruction had either alcohol septal ablation or intentional laceration of the anterior leaflet (LAMPOON).
Results
Eight-eight patients underwent TMVR; 38 MViV, 31 MViR, and 19 ViMAC procedures were performed. The median Society of Thoracic Surgery 30-day predicted risk of mortality was 8.2% (IQR 5.2, 19.9) for all. Sapien 3 (78%) and transseptal access (98%) were utilized in most cases. All-cause in-hospital mortality, technical, and procedural success were 8%, 83%, and 66% respectively. Median follow up was 1.4 years (IQR 0.5-2.9 years) and overall survival was 40% at 4 years. Differential survival rates were observed with MViV doing the best, followed by MViR and ViMAC having a <20% survival at 4 years. After adjusting for co-variates, MViV procedure was the strongest predictor of survival (HR 0.24 [95% CI 0.079-0.7]).
Conclusion
TMVR is performed in at high-risk patients with attenuated long-term survival. MViV has the best success and survival rate, but long-term survival in MViR and ViMAC is guarded.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Jun 2021; epub ahead of print

Single-access dual-injection technique (SADIT) for high-risk PCI with Impella CP.

Marmagkiolis K, Caballero JA, Cilingiroglu M, Iliescu C
The use of two arterial vascular accesses is now the standard of care in chronic total occlusion (CTO) percutaneous coronary interventions (PCI). When Impella support is needed, an additional vascular access may be necessary. We describe the first-in-man single-access, dual injection technique (SADIT). The Impella CP device was inserted in the left ventricle in the standard fashion. Subsequently, a 6 French sheath was placed at the \"10 o clock\" position and a second 4 French sheath was at the \"5 o clock\" position. This technique obviates the need for additional arterial access sites and potentially risk of complications. The SADIT technique is a simple way to perform high-risk, Impella-assisted coronary revascularization procedures necessitating dual coronary injections like CTO interventions. This strategy avoids unnecessary vascular complications from multiple access sites.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 07 Jun 2021; epub ahead of print

Derivation and validation of Pd/Pa in the assessment of residual ischemia post-intervention: A prospective all-comer registry.

Hakeem A, Hou L, Shah K, Agarwal SK, ... Ghosh B, Uretsky BF
Background
Measurement of post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) demonstrates residual ischemia in a large percentage of cases deemed angiographically successful which, in turn, has been associated with worse long-term outcomes. It has recently been shown that a resting pressure index, Pd/Pa, has prognostic value post stenting, however, its diagnostic value relative to FFR post-PCI has not been evaluated.
Methods
The diagnostic accuracy of Pd/Pa in identifying ischemia (FFR≤0.80) pre- and post-PCI was evaluated. Three patient subsets were analyzed. A reference pre-PCI cohort of 1,255 patients (1,560 vessels) was used to measure the accuracy of pre-PCI Pd/Pa vs. FFR. A derivation post-PCI group of 574 patient (664 vessels) was then used to calculate the diagnostic accuracy of post-PCI Pd/Pa vs. FFR. A final prospective validation cohort of 230 patients (255 vessels) was used to test and validate the diagnostic performance of post-PCI Pd/Pa.
Results
Median Pd/Pa and FFR were 0.90 (IQR 0.90-0.98) and 0.80 (IQR 0.71-0.88) in the reference pre-PCI model, 0.96 (IQR 0.93-1.00) and 0.87 (IQR 0.77-0.90) in the post-PCI derivation model, and 0.94 (IQR 0.89-0.97) and 0.84 (IQR 0.77-0.90) in the post-PCI validation model respectively. There was a strong linear correlation between Pd/Pa and FFR in all three models (p < 0.0001). Using ROC analysis, the optimal Pd/Pa cutoff value to predict a FFR ≤ 0.80 was ≤0.92 (AUC 0.87) in the pre-PCI model, ≤0.93 (AUC 0.85) in the post-PCI derivation model, and ≤ 0.90 (AUC 0.91) in the post-PCI validation model. Using a hybrid strategy of post-PCI Pd/Pa and post-PCI FFR when necessary (25% patients), overall diagnostic accuracy was improved to 95%.
Conclusions
Pd/Pa has excellent diagnostic accuracy for identifying ischemia post-intervention. Using a hybrid strategy of post-PCI Pd/Pa first, and FFR afterwards, if required, adenosine administration can be avoided in over 75% of physiologic assessments post intervention.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 07 Jun 2021; epub ahead of print

Intracardiac echocardiography for guidance of transcatheter left atrial appendage occlusion: An expert consensus document.

Berti S, Pastormerlo LE, Korsholm K, Saw J, ... Santoro G, Nielsen-Kudsk JE
Transcatheter left atrial appendage occlusion (LAAO) is an increasingly used alternative to oral anticoagulation in selected patients with atrial fibrillation. Intraprocedural imaging is a crucial for a successful intervention, with transesophageal echocardiography (TEE) as the current gold standard. Since some important limitations may affect TEE use, intracardiac echocardiography (ICE) is increasingly used as an alternative to TEE for guiding LAAO. The lack of a standardized imaging protocol has slowed the adoption of ICE into clinical practice. On the basis of current research and expert consensus, this paper provides a protocol for ICE support of left atrial appendage occlusion.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 03 Jun 2021; epub ahead of print

Directional atherectomy before paclitaxel coated balloon angioplasty in complex femoropopliteal disease: The VIVA REALITY study.

Rocha-Singh KJ, Sachar R, DeRubertis BG, Nolte-Ernsting CCA, ... Zeller T, REALITY Investigators
Background
Drug coated balloon (DCB) angioplasty significantly reduces reintervention rates in patients with symptomatic femoropopliteal peripheral artery disease (PAD). However, stand-alone DCB use in long, severely calcified lesions is frequently associated with vessel recoil and/or high-grade dissections necessitating provisional stent implantation.
Objectives
Assess the safety and effectiveness of a vessel preparation strategy with directional atherectomy (DA) prior to DCB angioplasty in patients with symptomatic severely calcified femoropopliteal PAD.
Methods
REALITY (NCT02850107) prospectively enrolled subjects at 13 multinational centers with 8-36 cm femoropopliteal stenoses or occlusions with bilateral vessel wall calcification treated with DA prior to DCB angioplasty. The primary effectiveness endpoint was 12-month primary patency, and the primary safety endpoint was freedom from major adverse events through 30 days. Independent angiographic and duplex core laboratories assessed outcomes and a Clinical Events Committee adjudicated events.
Results
A total of 102 subjects were enrolled; one lesion was treated per subject. The mean lesion length was 17.9 ± 8.1 cm, 39.0% were chronic total occlusions (mean lesion length 22.6 ± 8.6 cm); 86.2% of lesions exhibited moderate to severe bilateral calcification. Provisional stents were implanted in 8.8% (9/102) of subjects. Twelve-month primary patency rate was 76.7% (66/86) and freedom from CD-TLR rate was 92.6% (87/94). No device or procedure related deaths and one index-limb major amputation were reported.
Conclusions
Plaque excision with DA in patients with symptomatic severely calcified femoropopliteal arterial disease prior to DCB angioplasty is a safe and effective treatment strategy with a low provisional stent rate.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Jun 2021; epub ahead of print

Accurate assessment of coronary blood flow by continuous thermodilution technique: Validation in a swine model.

Adjedj J, Picard F, Mogi S, Bize A, ... De Bruyne B, Ghaleh B
Objective
To assess the accuracy of coronary thermodilution measurements made with the RayFlow® infusion catheter.
Background
Measurements of absolute coronary blood flow (ABF) and absolute microvascular resistance (R_μ ) by continuous coronary thermodilution can be obtained in humans but their accuracy using a novel dedicated infusion catheter has not yet been validated. We compared ABF values obtained at different infusion rates to coronary blood flow (CBF) values obtained using flow probes, in swine.
Methods
Twelve domestic swine were instrumented with coronary flow probes placed around the left anterior descending and circumflex coronary arteries. ABF was assessed with the RayFlow® infusion catheter during continuous saline infusion at fixed rates of 5 (n = 14), 10 (n = 15), 15 (n = 19), and 20 (n = 12) ml/min.
Results
In the 60 measurements, ABF measured using thermodilution averaged 41 ± 17 ml/min (range from 17 to 90) and CBF values obtained with the coronary flow probes averaged 37 ± 18 ml/min (range from 8 to 87). The corresponding R_μ values were 1532 ± 791 (range from 323 to 5103) and 1903 ± 1162 (range from 287 to 6000) Woods units using thermodilution and coronary flow probe assessments, respectively. ABF and R_μ values measured using thermodilution were significantly correlated with the corresponding measurements obtained using coronary flow probes (R = 0.84 [0.73-0.95] and R = 0.80 [0.69-0.88], respectively).
Conclusions
ABF and R_μ assessed by continuous saline infusion through a RayFlow® catheter closely correlate with measurements obtained with the gold standard coronary flow probes in a swine model.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Jun 2021; epub ahead of print

The appropriate use criteria: Improvements for its integration into real world clinical practice.

Klein LW, Tamis-Holland J, Kirtane AJ, Anderson HV, ... AUC Workgroup of the ISLC Endorsed by the Interventional Section Leadership Council, American College of Cardiology
The purpose of this position statement is to suggest ways in which future appropriate use criteria (AUC) for coronary revascularization might be restructured to: (1) incorporate improvement in quality of life and angina relief as primary goals of therapy, (2) integrate the findings of recent trials into quality appraisal, (3) employ the combined information of the coronary angiogram and invasive physiologic measurements together with the results of stress test imaging to assess risk, and (4) recognize the essential role that patient preference plays in making individualized therapeutic decisions. The AUC is a valuable tool within the quality assurance process; it is vital that interventionists ensure that percutaneous coronary intervention case selection is both evidence-based and patient oriented. Appropriate patient selection is an important quality indicator and adherence to evidence-based practice should be one metric in a portfolio of process and outcome indicators that measure quality.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Jun 2021; epub ahead of print

Computed tomography derived predictors of permanent pacemaker implantation after transcatheter aortic valve replacement: A meta-analysis.

Maier O, Piayda K, Afzal S, Polzin A, ... Kelm M, Veulemans V
Objectives
This meta-analysis sought to assess predictors of permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with focus on preprocedural multi-slice computed tomography (MSCT) derived data.
Background
Transcatheter aortic valve replacement (TAVR) has expanded to a well-established treatment for severe symptomatic aortic stenosis at high and intermediate surgical risk. PPI after TAVR remains one of the most frequent procedure-related complications and appears to be influenced by several factors.
Methods
The authors conducted a literature search in PubMed/MEDLINE and EMBASE databases to identify studies that investigated preprocedural MSCT data and the rate of PPI following TAVR with new-generation devices.
Results
Ten observational studies (n = 2707) met inclusion criteria for the final analysis. PPI was performed in 387 patients (14.3%) after TAVR. Patients requiring PPI had a larger annulus perimeter (MD: 1.66 mm; p < .001) and a shorter membranous septum length (MD: -1.1 mm; p < .05). Concerning calcification distribution, patients with requirement for new pacemaker implantation showed increased calcification of the left coronary cusp (MD: 47.6 mm³ ; p < .001), and the total left ventricular outflow tract (MD: 24.42 mm³ ; p < .01). Lower implantation depth (MD: 0.95 mm; p < .05) and oversizing (MD: 1.52%; p < .05) were procedural predictors of PPI following TAVR.
Conclusions
Besides the well-known impact of electrocardiographic and procedure-related factors on conduction disturbances, MSCT derived distribution of the aortic valve and left ventricular outflow tract calcification, as well as membranous septum length, are associated with an increased risk of PPI following TAVR.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 01 Jun 2021; epub ahead of print

Impact of high-sensitivity cardiac troponin T on survival and rehospitalization after transcatheter aortic valve replacement.

Schoechlin S, Schulz U, Ruile P, Hein M, ... Neumann FJ, Valina C
Background
Constant elevations of the serum concentration of cardiac troponin T (TnT) indicate a myocardial injury that may affect the long-term outcome of transcatheter aortic valve replacement (TAVR).
Objectives
We sought to investigate the impact of pre-TAVR TnT on outcomes after TAVR during long-term follow-up.
Methods
In a retrospective, observational study we compared long term outcomes after TAVR between tertiles of preinterventional high-sensitivity TnT. Systematic follow-up was performed annually for 5 years. The primary endpoint was a composite of all-cause death and any rehospitalization.
Results
Between 2010 and 2018, 2,129 patients with severe aortic valve stenosis underwent TAVR at our institution (mean age 82.6 years, 57.2% female, logistic EuroSCORE 20.5 ± 15.8). Boundaries for TnT tertiles were <21 ng/L and >42 ng/L. The median follow-up was 895 days. Three-year incidences for the primary endpoint were 70.9%, 76.6%, and 81.7% in the low, middle, and high tertile (log rank p < .001). Compared with the first tertile, the corresponding adjusted hazard ratios were 1.23 (95%-CI 1.08-1.40, p < .001) and 1.50 (95%-CI 1.32-1.70, p < .001) for the second and third tertile. We found consistent differences between TnT strata for all-cause death (3-year incidences 23.3%, 33.3%, and 47.1%; adjusted p < .001) and rehospitalization (3-year incidences 64.7%, 68.7% and 72.0%; adjusted p < .001), including significant differences in deaths (p < .001). The association between TnT and outcome was independent of coronary artery disease or low aortic valve gradient.
Conclusions
TnT before TAVR is strongly associated with all-cause death and rehospitalization during 3-year follow-up.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 01 Jun 2021; epub ahead of print

Deformation and stenosis of the sinus-SuperFlex-DS stent after ductal stenting for the hybrid stage 1 procedure.

Hribernik I, Thomson J, Bentham J
We present five cases of sinus-SuperFlex-DS stent stenosis during early follow up that resulted in inadequate ductal patency and required urgent re-stenting with a balloon-expandable stent. This causes concern that these stents lack sufficient radial force against ductal constriction and if used need to be kept under close scrutiny.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 01 Jun 2021; epub ahead of print

Usefulness of updated logistic clinical SYNTAX score based on MI-SYNTAX score in patients with ST-elevation myocardial infarction.

Kawashima H, Hara H, Wang R, Ono M, ... Onuma Y, Serruys PW
Objectives
To compare the predictive performances of the prewiring, postwiring MI-SYNTAX scores, prewiring, and postwiring Updated Logistic Clinical SYNTAX score (LCSS) for 2-year all-cause mortality post percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) patients.
Background
In patients with STEMI and undergoing primary PCI, coronary stenosis(es) distal to the culprit lesion is often observed after the restoration of coronary flow. To address comprehensively the complex coronary anatomy in these patients, prewiring and postwiring MI-SYNTAX scores have been reported in the literature. Furthermore, to enable individualized risk estimation for long-term all-cause mortality, the Updated LCSS has been developed by combining the anatomical SYNTAX score and clinical factors.
Methods
In the randomized GLOBAL LEADERS trial, anatomical SYNTAX score analysis was performed by an independent angiographic corelab for the first 4,000 consecutive patients as a prespecified analysis; of these, 545 presented with STEMI. The efficacy of the mortality predictions of the four scores at 2 years were evaluated based on their discrimination and calibration abilities.
Results
Complete data was available in 512 patients (93.9%). When the patients were stratified into two groups based on the median of the scores, the prewiring and postwiring Updated LCSSs demonstrated that the high-score groups were associated with higher rates of 2-year all-cause mortality compared to the low-score groups (6.6 vs. 1.2%; log-rank p = .001 and 6.6 vs. 1.2%; log-rank p = .001, respectively). There were no statistically significant differences for predicting the mortality between the prewiring (area under the curve [AUC] 0.625), postwiring MI-SYNTAX score (AUC 0.614), prewiring (AUC 0.755), and postwiring Updated LCSS (AUC 0.757). In the integrated discrimination improvement (IDI), the prewiring MI-SYNTAX score had a better discrimination for the mortality than the postwiring MI-SYNTAX score (IDI -0.0082; p = .029). The four scores had acceptable calibration abilities for 2-year all-cause mortality.
Conclusions
The prewiring Updated LCSS predicts long-term all-cause mortality with clearly useful discrimination and acceptable calibration. Since the postwiring MI-SYNTAX score does not improve mortality prediction, the prewiring MI-SYNTAX score may be preferred for the 2-year mortality prediction using the Updated LCSS.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 May 2021; 97:E919-E928

Iatrogenic aorta-coronary dissection: Case report and systematic review.

Cereda AF, Toselli M, Khokhar A, Sticchi A, ... Colombo A, Giannini F
Objectives and background
Iatrogenic aorto-coronary dissection (ICD) is one of the most feared complications of interventional cardiology. Although rare, it is characterized by anterograde coronary ischemia and a concomitant aortic dissection, with potentially fatal consequences.
Methods
We present an example case of IACD and an accurate case-series review of the literature including 125 published cases.
Results
There were no significant predisposing factors and the IACD occurred equally in elective and urgent procedures. A significant number of IACDs were associated with CTO procedures. The factors associated with a worse outcome were hemodynamic instability, the presence of anterograde ischemia, and the extent of dissection according to the Dunning classification. Bail-out stenting was the most used strategy and its failure was associated with mortality.
Conclusion
The main features of IACD are anterograde ischemia, retrograde dissection, and hemodynamic instability, each of them should be addressed with no time delay, possibly with bailout stenting, the most employed exit-strategy. According to our proposed algorithm, a shock team approach is required to coordinate the interdisciplinary skills and enabled patients to receive the best treatment.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 May 2021; 97:E900-E910

Combined use of rotational and excimer lASER coronary atherectomy (RASER) during complex coronary angioplasty-An analysis of cases (2006-2016) from the British Cardiovascular Intervention Society database.

Protty MB, Gallagher S, Farooq V, Sharp ASP, ... O\'Kane P, Kinnaird T
Introduction
Combining rotational (RA) and excimer laser coronary atherectomy (ELCA)-RASER atherectomy-is technique utilized in the percutaneous management of calcific coronary disease. The evidence base examining its safety and utility is sparse and limited to small case-series. This study examines the patterns and outcomes of RASER atherectomy use in the largest cohort to date.
Methods
Using the British Cardiac Intervention Society database, data were analyzed on all PCI procedures in the UK between 2006 and 2016. Descriptive statistics and multivariate logistic regressions were used to examine baseline, procedural, and outcome associations with RASER.
Results
We identified 153 (0.02%) RASER atherectomy cases out of 686,358 PCI procedures. Baseline covariates associated with RASER use were age, BMI, diabetes, stable coronary disease, and previous CABG. Procedural co-variates associated with RASER were CTO-PCI, the use of more/longer stents, intravascular imaging, cutting balloons, and microcatheters. Adjusted rates of in-hospital major adverse cardiac/cerebrovascular events (MACCE) were not significantly different with RASER. However, there were higher odds of arterial complications (OR 3.23, 95% CI: 1.58-6.61), slow flow (OR 3.50, 95% CI: 1.29-9.55), and shock induction (OR 9.66, 95% CI: 3.44-27.06).
Conclusions
RASER atherectomy use in complex PCI is associated with higher risk baseline and procedural characteristics. Although increased rates of shock induction, slow flow, and arterial complications were observed, RASER does not increase the likelihood of in-hospital MACCE, major bleeding, or death.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 May 2021; 97:E911-E918

Coronary sinus anatomical features: Description and procedural implications during coronary sinus Reducer implantation.

Wilgenhof A, Zivelonghi C, Verheye S, Vermeersch P, ... Stella P, Agostoni P
Objectives
We hypothesized that some coronary sinus (CS) anatomies allow a more straightforward CS Reducer (CSR) implantation.
Background
Recent decades have seen a rise in patients with chronic angina. When complete revascularization and maximal medical therapy fail to reduce symptoms, CSR has become a new therapeutic option.
Methods
We identified a classical C-shape-a near horizontal course of the proximal portion of a circular CS-in a retrospective analysis of 47 CSR implantations and compared the procedural time, fluoroscopic time, contrast use, presence of valves or bifurcations and procedural complications with the non-C-shape CS anatomy.
Results
We found a significant difference in procedural (20.0 [19.0-24.7] min vs. 24.5 [20.7-51.0] min; p = .028 and fluoroscopic time (9.5 [7.5-14.5] min vs. 11.0 [7.9-30.0] min; p = .016). There was no significant difference in contrast use. The presence of bifurcations or valves along the CS course did not influence the procedural timings.
Conclusion
This study is the first systematic evaluation of CS anatomy and its procedural implications. We identified a favorable C-shape anatomy which allows for a more straightforward implantation. Operators should be aware of the different implications of CS anatomy, their influence on guiding catheter stability and overall procedure complexity.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 May 2021; 97:E929-E935

Prevalence and prognostic impact of hsCRP elevation are age-dependent in women but not in men undergoing percutaneous coronary intervention.

Blum M, Cao D, Chandiramani R, Goel R, ... Sharma SK, Mehran R
Background
High-sensitivity C-reactive protein (hsCRP) predicts outcomes after percutaneous coronary intervention (PCI).
Objective
We studied the prevalence and prognostic impact of hsCRP elevation according to age in men and women undergoing PCI.
Methods
We included patients undergoing PCI at our center from 2010 until 2017, excluding those with myocardial infarction (MI) on presentation, neoplastic disease and hsCRP >10 mg/L at baseline. Elevated hsCRP was defined as >3 mg/L. The outcome of interest was major adverse cardiac events (MACE) consisting of all-cause death, MI and target vessel revascularization. The association between hsCRP elevation and outcomes was assessed using adjusted Cox models.
Results
10,432 men and 4,345 women were included. Elevation of hsCRP was present in 25.7% of men and 37.0% of women (p < .01). In men, prevalence of hsCRP elevation was stable across age strata (p_trend  = .42). In women, hsCRP elevation was most prevalent in patients <50 years (44.6%) and decreased stepwise with increasing age (p_trend  < .001). After stratifying the population into age quartiles (Q1: <59 years, Q2: 59-66 years, Q3: 67-74 years, Q4: ≥75 years), hsCRP elevation was associated with increased risk of MACE across all age groups in men (HR [95% CI] Q1: 1.49 [1.12-1.98]; Q2: 1.51 [1.21-2.06]; Q3: 1.76 [1.27-2.51]; Q4: 1.43[1.03-1.97]). In women, hsCRP elevation was associated with increased risk of MACE only among older patients (HR [95% CI] Q1: 1.08 [0.64-0.82]; Q2: 1.52 [0.93-2.46]; Q3: 1.65 [1.08-2.50]; Q4: 1.52 [1.02-1.28]).
Conclusion
Among patients undergoing PCI, prevalence and prognostic value of hsCRP elevation were age-dependent exclusively in women.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 May 2021; 97:E936-E944

Left main coronary artery compression in pulmonary hypertension.

Labin JE, Saggar R, Yang EH, Lluri G, ... Aksoy O, Parikh RV
Extrinsic compression of the left main coronary artery (LMCA) by a dilated pulmonary artery (PA) in the setting of pulmonary arterial hypertension (PAH) is an increasingly recognized disease entity. LMCA compression has been associated with angina, arrhythmia, heart failure, and sudden cardiac death in patients with PAH. Recent studies suggest that at least 6% of patients with PAH have significant LMCA compression. Screening for LMCA compression can be achieved with computed coronary tomography angiography, with a particular emphasis on assessment of PA size and any associated downward displacement and reduced takeoff angle of the LMCA. Indeed, evidence of a dilated PA (>40 mm), a reduced LMCA takeoff angle (<60°), and/or LMCA stenosis on CCTA imaging should prompt further diagnostic evaluation. Coronary angiography in conjunction with intravascular imaging has proven effective in diagnosing LMCA compression and guiding subsequent treatment. While optimal medical therapy and surgical correction remain in the clinician\'s arsenal, percutaneous coronary intervention has emerged as an effective treatment for LMCA compression. Given the prevalence of LMCA compression, its associated morbidity, and mortality, and the wide array of successful treatment strategies, maintaining a high degree of suspicion for this condition, and understanding the potential treatment strategies is critical.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 May 2021; 97:E956-E966

Tip fracture of the crown of orbital atherectomy device in angulated left circumflex lesion.

Karrowni W, Zaeiter H, Mansour S, Nassar P
Atherectomy, whether rotational or orbital, is an essential and established method for treatment of calcified coronary lesions. By modifying the plaque, atherectomy lessens the risk of plaque shift and facilities stent delivery and stent expansion. Atherectomy technique is meticulous and challenging especially in tortuous and angulated coronary arteries. Herein, we describe the rare case of occurrence and the management of fracture of the tip of the crown of CSI Diamondback orbital atherectomy device during treatment of severely angulated and calcified ostial left circumflex lesion.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 May 2021; 97:1399-1401

Transcarotid versus transfemoral access in patients undergoing transcatheter aortic valve replacement with complex aortofemoral anatomy.

Leclercq F, Choteau R, Cayla G, Chamard C, ... Akodad M, Gandet T
Aims
While major vascular complications (MVC) remains an issue after Transfemoral (TF) transcatheter aortic valve replacement (TAVR), we compared outcomes in TF versus transcarotid (TC) approaches in patients with complex vascular anatomy.
Methods and results
Among patients undergoing TAVR in our center between 2015 and 2018, we evaluated patients with complex vascular anatomy defined on CT scan as: (a) iliofemoral diameter between 5.5 and 6 mm or <6.5 mm with severe calcifications or tortuosity AND/OR (b) abdominal aorta pathology. The primary endpoint included access failure, mortality, MVC, major bleeding and stroke at 1-month. Among 483 patients, 131 (31.2%) with complex vascular anatomy underwent TF (n = 51;39.2%) or TC (n = 80;60.8%) TAVR. The mean age was 81.7 ± 6.9. TC group had higher STS score (p = .01), higher incidence of coronary artery disease (p = .04) and lower left ventricular ejection fraction (p < .001). In TC group, primary endpoint occurred twice less without reaching significance compared to TF group (n = 8; 10.0% vs. n = 10; 19.6% respectively; p = .1). Incidence of MVC was higher in TF group (11.8 vs. 1.3% in the TC group; p = .01) with similar incidence of stroke between groups (p = .8).
Conclusions
Despite higher patient risk profile, TC approach in complex aortofemoral anatomy provides similar favorable outcomes with less MVC compared to TF approach.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 May 2021; 97:1452-1459

Amplatzer device closure of femoral pseudoaneurysm after transcatheter aortic valve implantation: An alternative to surgical repair.

Tanseco KV, Alsanjari O, Cockburn J, Hildick-Smith D
Iatrogenic femoral artery pseudoaneurysm is an infrequent but troublesome complication of vascular access during transcatheter aortic valve implantation. There are non-invasive, percutaneous and surgical treatment options for management of this complication. This case series report demonstrates a novel technique using an Amplatzer Duct Occluder II closure device to successfully treat iatrogenic common femoral pseudoaneurysm following transcatheter aortic valve implantation.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 May 2021; 97:E967-E972

Incidence, predictors and outcomes of device-related thrombus after left atrial appendage closure with the WATCHMAN device-Insights from the EWOLUTION real world registry.

Sedaghat A, Nickenig G, Schrickel JW, Ince H, ... Boersma LVA, EWOLUTION study group
Background
In this analysis of the EWOLUTION registry, we evaluated the incidence, relevance and predictors of device-related thrombus in a large multi-center real-world cohort undergoing LAAc with the WATCHMAN device.
Methods and results
We analyzed the 835 patients who underwent percutaneous LAA closure with the WATCHMAN device in the EWOLUTION registry in whom at least one TEE follow up was performed. Patients were 74 ± 9 y/o and were at high risk for stroke and bleeding (CHA2DS2-VASC-Score 4.3 ± 1.7; HAS-BLED-Score 2.3 ± 1.2). Device-related thrombus was detected in 4.1% (34/835) after a median of 54 days (IQR 42-111 days) with 91.2% (31/34) being detected within 3 months after the procedure or at the time of first TEE. Hereby DRT occurred irrespective of postprocedural anticoagulation. Patients with DRT more frequently had long-standing, non-paroxysmal atrial fibrillation (82.4 vs. 64.9%, p < .01), evidence of dense spontaneous echo contrast (26.5 vs. 11.9%, p = .03) and larger LAA diameters at the ostium (22.8 ± 3.5 vs. 21.1 ± 3.5 mm, p < .01) compared to patients without DRT. Left ventricular ejection fraction, device compression ratio and the incidence of renal dysfunction did not differ between the two groups. In a multivariate analysis, only non-paroxysmal atrial fibrillation identified as an independent predictor of developing DRT. Specific treatment of DRT was initiated in 62% (21/34) of patients whereas resolution was confirmed in 86% (18/21) of cases. Overall, no significant differences in annual rates of stroke/TIA or systemic embolism were observed in patients with or without DRT (DRT 1.7 vs. No-DRT 2.2%/year, p = .8).
Conclusions
In real-world patients undergoing LAAc with the WATCHMAN device, DRT is rare. DRT was most frequently detected within the first 3 months after LAAc regardless of post-procedural regimen and was not associated with an increased risk of stroke or SE. While long-standing atrial fibrillation was the only independent factor associated with DRT, medical treatment of DRT resulted in a resolution of thrombi in most cases.

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Catheter Cardiovasc Interv: 31 May 2021; 97:E1019-E1024