Multicenter clinical evaluation of a piezoresistive-MEMS-sensor rapid-exchange pressure microcatheter system for fractional flow reserve measurement.

Li C, Yang J, Dong S, Dong L, ... Ge J, SUPREME Study Investigators
Objectives
This multicenter, prospective clinical study investigates whether the microelectromechanical-systems-(MEMS)-sensor pressure microcatheter (MEMS-PMC) is comparable to a conventional pressure wire in fractional flow reserve (FFR) measurement.
Background
As a conventional tool for FFR measurement, pressure wires (PWs) still have some limitations such as suboptimal handling characteristics and unable to maintain the wire position during pullback assessment. Recently, a MEMS-PMC compatible with any 0.014″ guidewire is developed. Compared with the existing optical-sensor PMC, this MEMS-PMC has smaller profiles at both the lesion crossing and sensor packaging areas.
Methods
Two hundred and forty-two patients with visually 30-70% coronary stenosis were enrolled at four centers. FFR was measured first with the MEMS-PMC, and then with the PW. The primary endpoint was the Bland-Altman mean bias between the MEMS-PMC and PW FFR.
Results
From the 224-patient per-protocol data, quantitative coronary angiography showed 17.9% and 55.9% vessels had diameter < 2.5 mm and stenosis >50%, respectively. The two systems\' mean bias was -0.01 with [-0.08, 0.06] 95% limits-of-agreement. Using PW FFR≤0.80 as cutoff, the MEMS-PMC per-vessel diagnostic accuracy was 93.4% [95% confidence interval: 89.4-96.3%]. The MEMS-PMC\'s success rate was similar to that of PW (97.5 vs. 96.3%, p = .43) with no serious adverse event, and its clinically-significant (>0.03) drift rate was 43% less (9.5 vs. 16.7%, p = .014).
Conclusions
Our study showed the MEMS-PMC is safe to use and has a minimal bias equal to the resolution of current FFR systems. Given the MEMS-PMC\'s high measurement accuracy and rapid-exchange nature, it may become an attractive new tool facilitating routine coronary physiology assessment.

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

Catheter Cardiovasc Interv: 04 May 2021; epub ahead of print

Impact of stent length and diameter on 10-year mortality in the SYNTAXES trial.

Hara H, Ono M, Kawashima H, Kogame N, ... Serruys PW, SYNTAX Extended Survival Investigators
Objectives
We investigated the impact of total stent length (TSL) and average nominal stent diameter (ASD) on 10-year mortality after percutaneous coronary intervention (PCI) in the SYNTAXES trial.
Background
TSL and ASD in patients treated with PCI are associated with major adverse cardiovascular events. However, the treatment effect of PCI with extensive and/or small stenting as compared with coronary artery bypass grafting (CABG) for complex coronary artery disease has not been fully evaluated.
Methods
Impacts on mortality of extensive stenting defined as TSL >100 mm and small stenting as ASD <3 mm were analyzed in 893 PCI patients and were compared to 865 CABG patients.
Results
TSL as a continuous variable was significantly associated with 10-year mortality (adjusted hazard ratio [HR], 1.05 [1.01-1.09] per 10 mm increase). PCI patients with extensive stenting had a higher 10 year mortality than CABG patients (adjusted HR, 1.97 [1.41-2.74]) or not- extensive stenting PCI (adjusted HR, 1.94 [1.36-2.77]). Although ASD did not have a significant association with 10 year mortality (adjusted HR, 0.97 [0.85-1.11] per 0.25 mm increase), PCI with small stents was associated with a higher 10 year mortality, compared to CABG (adjusted HR, 1.66 [1.23-2.26]) and PCI performed with large stents (adjusted HR, 1.74 [1.19-2.53]). Patients treated with not-extensive and large stents had similar mortality rates (24.0 versus 23.8%) as those treated with CABG.
Conclusions
Extensive and small stenting were associated with higher 10 year mortality, compared with CABG. When patients have to be treated with extensive or small stenting, revascularization with CABG should be preferred.

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

Catheter Cardiovasc Interv: 04 May 2021; epub ahead of print

Clinical outcome of patients with ST-elevation myocardial infarction and angiographic evidence of coronary artery ectasia.

Baldi C, Silverio A, Esposito L, Di Maio M, ... Vecchione C, Galasso G
Objectives
The aim of this study was to describe the prevalence of coronary artery ectasia (CAE) in patients with ST-elevation myocardial infarction (STEMI) and to compare the long-term outcome of subjects with and without CAE undergoing emergent coronary angiography.
Background
The prognostic impact of CAE in STEMI patients has been poorly investigated.
Methods
This retrospective, single-center, study included consecutive patients with STEMI undergoing emergent coronary angiography from January 2012 to December 2017. The primary endpoint was the assessment of recurrent myocardial infarction (MI) in patients with versus those without CAE at the longest available follow-up. The propensity score weighting technique was employed to account for potential selection bias between groups.
Results
From 1,674 patients with STEMI, 154 (9.2%) had an angiographic evidence of CAE; 380 patients were included in the no CAE group. CAE patients were more often males and smokers, and showed a lower prevalence of diabetes than no CAE patients. After percutaneous coronary intervention, the corrected thrombolysis in MI frame count (p < .001) and the myocardial blush grade (p < .001) were significantly lower in CAE than in no CAE patients. The mean follow-up was 1,218.3 ± 574.8 days. The adjusted risk for the primary outcome resulted significantly higher in patients with CAE compared to those without (adjusted HR: 1.84; p = .017). No differences in terms of all-cause and cardiac death were found between groups.
Conclusions
In this study, STEMI patients with CAE had a distinct clinical and angiographic profile, and showed a significantly higher risk of recurrent MI than those without CAE.

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

Catheter Cardiovasc Interv: 04 May 2021; epub ahead of print

Transcatheter mitral valve repair in a high-surgical risk patient with severe degenerative mitral regurgitation using the novel DragonFly™ Transcatheter Repair device-First in man implantation in China.

Liu X, Pu Z, Lim DS, Wang J
Transcatheter repair of mitral regurgitation (MR) by edge-to-edge therapy has become increasingly accepted for patients with severe MR at high or prohibitive surgical risk in primary or degenerative mitral regurgitation (DMR). The technological approach has evolved from the initial transcatheter edge-to-edge device to improve on its acute reduction in MR and durability of results, particularly in complex primary pathology. In this study, we reported the first case of DragonFly™ Transcatheter Valve Repair device in a patient with severe DMR.

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

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

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: 03 May 2021; epub ahead of print

Outcomes following PCI in CABG candidates during the COVID-19 pandemic: The prospective multicentre UK-ReVasc registry.

Kite TA, Ladwiniec A, Owens CG, Chase A, ... Gershlick AH, UK-ReVasc Registry Investigators
Objectives
To describe outcomes following percutaneous coronary intervention (PCI) in patients who would usually have undergone coronary artery bypass grafting (CABG).
Background
In the United Kingdom, cardiac surgery for coronary artery disease (CAD) was dramatically reduced during the first wave of the COVID-19 pandemic. Many patients with \"surgical disease\" instead underwent PCI.
Methods
Between 1 March 2020 and 31 July 2020, 215 patients with recognized \"surgical\" CAD who underwent PCI were enrolled in the prospective UK-ReVasc Registry (ReVR). 30-day major cardiovascular event outcomes were collected. Findings in ReVR patients were directly compared to reference PCI and isolated CABG pre-COVID-19 data from British Cardiovascular Intervention Society (BCIS) and National Cardiac Audit Programme (NCAP) databases.
Results
ReVR patients had higher incidence of diabetes (34.4% vs 26.4%, P = .008), multi-vessel disease with left main stem disease (51.4% vs 3.0%, P < .001) and left anterior descending artery involvement (94.8% vs 67.2%, P < .001) compared to BCIS data. SYNTAX Score in ReVR was high (mean 28.0). Increased use of transradial access (93.3% vs 88.6%, P = .03), intracoronary imaging (43.6% vs 14.4%, P < .001) and calcium modification (23.6% vs 3.5%, P < .001) was observed. No difference in in-hospital mortality was demonstrated compared to PCI and CABG data (ReVR 1.4% vs BCIS 0.7%, P = .19; vs NCAP 1.0%, P = .48). Inpatient stay was half compared to CABG (3.0 vs 6.0 days). Low-event rates in ReVR were maintained to 30-day follow-up.
Conclusions
PCI undertaken using contemporary techniques produces excellent short-term results in patients who would be otherwise CABG candidates. Longer-term follow-up is essential to determine whether these outcomes are maintained over time.

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

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

Clinical outcomes of percutaneous coronary intervention for chronic total occlusion in prior coronary artery bypass grafting patients.

Shoaib A, Mohamed M, Curzen N, Ludman P, ... Mamas MA, British Cardiovascular Intervention Society (BCIS) and the National Institute for Cardiovascular Outcomes Research (NICOR)
Objective
To compare the clinical characteristics and outcomes in patients with stable angina who have undergone chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in native arteries with or without prior coronary artery bypass grafting (CABG) surgery in a national cohort.
Background
There are limited data on outcomes of patients presenting with stable angina undergoing CTO PCI with previous CABG.
Methods
We identified 20,081 patients with stable angina who underwent CTO PCI between 2007-2014 in the British Cardiovascular Intervention Society database. Clinical, demographical, procedural and outcome data were analyzed in two groups; group 1-CTO PCI in native arteries without prior CABG (n = 16,848), group 2-CTO PCI in native arteries with prior CABG (n = 3,233).
Results
Patients in group 2 were older, had more comorbidities and higher prevalence of severe left ventricular systolic dysfunction. Following multivariable analysis, no significant difference in mortality was observed during index hospital admission (OR:1.33, CI 0.64-2.78, p = .44), at 30-days (OR: 1.28, CI 0.79-2.06, p = .31) and 1 year (OR:1.02, CI 0.87-1.29, p = .87). Odds of in-hospital major adverse cardiovascular events (MACE) (OR:1.01, CI 0.69-1.49, p = .95) and procedural complications (OR:1.02, CI 0.88-1.18, p = .81) were similar between two groups but procedural success rate was lower in group 2 (OR: 0.34, CI 0.31-0.39, p < .001). The adjusted risk of target vessel revascularization (TVR) remained similar between the two groups at 30-days (OR:0.68, CI 0.40-1.16, P-0.16) and at 1 year (OR:1.01, CI 0.83-1.22, P-0.95).
Conclusion
Patients with prior CABG presenting with stable angina and treated with CTO PCI in native arteries had more co-morbid illnesses but once these differences were adjusted for, prior CABG did not independently confer additional risk of mortality, MACE or TVR.

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

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

Superselective adrenal arterial embolization for idiopathic hyperaldosteronism: 12-month results from a proof-of-principle trial.

Dong H, Zou Y, He J, Deng Y, ... Gao R, Jiang X
Objectives
This study aimed to assess the safety, blood pressure changes, and biochemical responses of superselective adrenal artery embolization (SAAE) in hypertensive patients with idiopathic hyperaldosteronism (IHA).
Background
SAAE is a minimally invasive procedure that has been used to successfully treat aldosterone-producing adenoma. However, its effect for patients with IHA is unevaluated.
Methods
A total of 41 hypertensive patients who were diagnosed with IHA and underwent SAAE at the Fuwai Hospital between December 2010 and June 2016 were prospectively enrolled. The blood pressure, antihypertensive medications, plasma aldosterone and potassium levels, and adverse events were assessed. The primary endpoint was the change in home blood pressure at 12 months, compared with baseline.
Results
SAAE was technically successful in 39 patients. Postoperatively, home and 24-hr mean blood pressures were reduced by 14/9 and 10/7 mmHg at 1 month, respectively, and by 13/7 and 11/7 mmHg at 12 months, respectively. The number of antihypertensive agents used reduced by 1.0 and 1.1 at 1 month and 12 months, respectively (all p < .001). Compared with baseline (524.0 pmol/L), the standing plasma aldosterone reduced to 293.4 pmol/L at 12 months (p < .001). Serum potassium increased from 3.0 to 4.1 mmol/L while the rate of potassium supplement and mineralocorticoid receptor antagonist use reduced from 87.1 and 89.7%, respectively, to 28.2 and 17.9%, respectively, at 12 months (all p < .001). There were no serious complications in the perioperative and 12-month follow-up periods.
Conclusions
SAAE was effective and feasible for IHA treatment, without serious complications, therefore, maybe a potential treatment.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Apr 2021; 97:976-981

Nine-month angiographic and 2-year clinical outcomes of the RECOVERY trial: A randomized study of the biodegradable polymer sirolimus-eluting COMBO dual-therapy stent versus a polymer-free sirolimus-eluting stent in Chinese patients.

Tao L, Li Z, Yin Z, Lin W, ... Xu B, RECOVERY Trial Investigators
Objectives
We evaluated the safety and efficacy of the novel dual-therapy sirolimus-eluting and endothelial progenitor cell (EPC) capture COMBO stent.
Background
(Very) late stent thrombosis (ST) and neo-atherosclerosis limit the performance of drug-eluting stents. The capture of EPCs accelerates stent re-endothelialization, thereby potentially decreasing the risk of restenosis and ST.
Methods
In total, 440 patients with de novo lesions in native coronary arteries were randomized (1:1) to either receive the COMBO stent (n = 220) or Nano polymer-free sirolimus-eluting stent (n = 220). The primary endpoint was the 9-month angiographic in-segment late lumen loss (LLL). Secondary endpoints included target lesion failure (TLF), a patient-oriented composite endpoint (PoCE), and ST.
Results
At 9 months, the COMBO in-segment LLL (0.29 ± 0.46 mm) was non-inferior to that of the Nano comparator stent (0.31 ± 0.44 mm; p_{non-inferiority}  < .0001). Clinical outcomes were also similar between the COMBO and Nano stents, with TLF rates of 9.3% and 7.9% (p = .61) at 12 months, and 9.4% and 8.0% (p = .62) at 24 months, respectively. The PoCE rate was 14.8% and 10.6% (p = .19) at 12 months, and 16.0% and 11.3% (p = .16) at 24 months, respectively. Ischemia-driven target lesion revascularization rates were 6.0% and 3.7% (p = .26) at 12 months, and 6.2% and 3.8% (p = .26) at 24 months, respectively. No case of ST occurred in either group.
Conclusions
The RECOVERY trial has shown the COMBO stent was effective, meeting the primary non-inferiority angiographic endpoint, and safe, with an overall low rate of clinical events in both stent groups, including no ST for up to 2 years.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Apr 2021; 97:966-975

External carotid artery stenting in patients with ipsilateral internal carotid artery occlusion: Peri-operative and 12-month follow-up.

Dong H, Jiang X, Zou Y, Chen Y, ... Xu B, Gao R
Objectives
This study aimed to evaluate the safety and clinical efficacy of external carotid artery (ECA) stenting in patients with ipsilateral internal carotid artery (ICA) occlusion.
Background
In patients with ICA occlusion, severe ipsilateral ECA stenosis may exacerbate pre-existing cerebral ischemia and cognitive impairment. It remains unclear whether ECA stenting to normalize ECA collaterals to the cerebralis alleviates cerebral ischemia and improves cognitive function.
Methods
From January 2008 to June 2019, we retrospectively collected clinical data of 36 consecutive patients with ipsilateral ICA occlusion who had undergone ECA stenting (mean age, 66.7 ± 8.3 years; males, n = 26 [72.2%]). Neurocognitive test results, including Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MOCA) tests, symptom assessment, and adverse events were recorded.
Results
ECA stenting was successful in all 36 patients. Intra-operatively, six (16.7%) patients experienced hemodynamic depression during balloon dilation and recovered completely within 2 days. Within a 12-month follow-up period, two patients experienced a transient ischemic attack, one patient had a contralateral minor stroke, and 33 patients remained asymptomatic. No other adverse events occurred in the peri-operative or follow-up periods. Compared with baseline, significant MMSE (25.3 ± 1.3 vs. 23.6 ± 1.7; p < .05) and MOCA (24.1 ± 1.3 vs. 22.8 ± 1.7; p < .05) test score improvements were observed 3 months post-operatively and were maintained throughout follow-up.
Conclusions
ECA stenting may improve cerebral ischemia and cognitive function in patients with severe ECA stenosis and ipsilateral ICA occlusion; however, further research is required to support our findings.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Apr 2021; 97:982-987

The transseptal puncture experience: Safety insights from FDA MAUDE database.

Morcos R, Megaly M, Desai A, Alkouli M, ... Khalili H, Maini B
Background
There is a paucity of literature on safety and efficacy of various transseptal puncture (TSP) needles.
Objectives
To assess the reported mechanisms of failure, complications, and outcomes among the most frequently used transseptal needles in the United States.
Methods
We queried the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between January 2011 and January 2021 for reports on the most commonly used transseptal needles: NRG (Baylis Medical, Montreal, Canada), and BRK (St. Jude, Saint Paul, MN)]. The primary outcome was the mechanism of failure. Secondary outcomes included clinical consequences of device failure.
Results
The final analysis included 306 reports of failure/complication with TSP needles (NRG n = 70, BRK n = 236). The most commonly reported mode of failure was detachment of the needle component (i.e., clip, hub, stopcock, shaft, spring, or needle tip) (14.7% overall; 17.8% BRK; and 4.3% NRG). Among these reports, cardiac perforation was the most common complication (69.9% overall; 69.1% for BRK; and 72.9% for NRG). Pericardiocentesis was the second most commonly reported complication (45.1% overall; 48.3% for BRK; and 34.3% for NRG). The procedure was successfully completed in 33.3% of all cases (36.4% for BRK and 22.9% for NRG), while surgical conversion was needed in (13.4% overall; 14% for BRK and 11.4% for NRG) of the reports. Death occurred in 3.9% of all cases overall (3.4% for BRK and 5.7% for NRG).
Conclusions
Needle detachment was the most common mode of failure, and cardiac perforation was the most common complication reported with TSP needles. Future efforts should focus on innovative TSP needle design, best practice guidelines, including role of imaging guidance, and increased TSP training.

© 2021 Wiley Periodicals LLC.

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

Successful modeling of long term outcomes in end-stage renal disease patients undergoing percutaneous coronary intervention with drug-eluting stents.

Dunn AN, Huded C, Raymond R, Lincoff AM, ... Kapadia S, Ellis SG
Objectives
The objective of this study is to identify and model risk factors for major adverse cardiac events (MACE) and all-cause mortality among patients with ESRD treated with PCI using DES.
Background
Patients with end-stage renal disease (ESRD) have poor long-term outcomes after percutaneous coronary intervention (PCI) compared with non-ESRD patients. However, there is a paucity of literature regarding risk factors associated with outcomes of ESRD patients after PCI with drug-eluding stents (DES).
Methods
This retrospective cohort study includes all patients with ESRD who underwent first-time PCI with DES at a single, high-volume hospital between 1/1/2005 and 12/31/2015, with follow-up through 9/1/2019. Primary outcomes were MACE (cardiac death, myocardial infarction, or unplanned revascularization) and all-cause mortality.
Results
Five-year MACE was 83.0% and five-year morality was 77.9% in patients with ESRD (n = 285). Among ESRD patients, factors independently associated with MACE were C-reactive peptide level, SYNTAX score, peripheral vascular occlusive disease, hemoglobin, and treatment of a restenotic lesion (c-index = 0.66). Factors independently associated with mortality in ESRD patients were age, SYNTAX score, non-use of statins at baseline, insulin-dependent diabetes, chronic obstructive pulmonary disease (COPD), peripheral vascular occlusive disease, and platelet count (c-index = 0.65).
Conclusions
Despite relatively poor 1-and 5-year outcomes among ESRD patients after PCI, risk of MACE and mortality among this cohort can be successfully modelled, which meaningfully informs clinicians regarding management of ESRD patients with coronary artery disease (CAD). Further investigations are necessary to determine whether or not outcomes might be improved through risk profile modification.

© 2021 Wiley Periodicals LLC.

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

Future culprit detection based on angiography-derived FFR.

Pagnoni M, Meier D, Candreva A, Maillard L, ... Muller O, Fournier S
Objectives
We sought to characterize the hemodynamic impact of mild coronary artery disease (CAD) using quantitative flow ratio (QFR, an angiography-derived fractional flow reserve [FFR]) in a population of patients with only non-significant CAD at baseline that subsequently experienced a myocardial infarction (MI).
Background
The discriminatory value of FFR in patients with mild CAD remains imperfect.
Methods
We retrospectively included patients who underwent invasive coronary angiography for an MI, in whom another angiogram had been performed within the previous 5 years. Three-dimensional quantitative coronary angiography, QFR, and lesion length analysis were conducted on lesions responsible for the MI (future culprit lesions, [FCL]) as well as on control lesions (non-culprit lesions, [NCL]).
Results
Eighty-three FCL and 117 NCL were analyzed in 83 patients: FCL were more severe (median % diameter of stenosis [DS] 39.1% [29.8; 45.7] vs. 29.8% [25.0; 37.2], p < .001), had lower QFR values (0.94 [0.86; 0.98] vs. 0.98 [0.96; 1.00], p < .001) and tended to be longer (15.2 mm [10.0; 27.3] vs. 12.7 mm [9.3; 22.4], p = .070) than NCL. In lesions with an interval < 2 years between baseline angiography and MI, the difference in QFR was more pronounced compared to the lesions with a longer interval (FCL: 0.92 [0.85; 0.97] vs. NCL: 0.98 [0.94; 1.00], p < .001 and FCL: 0.96 [0.88; 1.00] vs. NCL: 0.98 [0.96;1.00], p = .006 respectively)
Conclusion:
Mild coronary stenoses that are subsequently responsible for an MI (FCL) exhibit a higher DS and lower QFR years before the event. Furthermore, FCL with a lower QFR at baseline appear to lead earlier to MI.

© 2021 Wiley Periodicals LLC.

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

Correction of Sinus Venosus Atrial Septal Defects with the 10 zig Covered CP 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 non-stenotic SVC and expanding the stent at the wider SVC-RA junction without obstructing the anomalous right upper pulmonary vein (RUPV). The 10-zig covered CP (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 embolisation 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<0.001) and RVEDVi from 149.1+35.4 to 95.6+21.43 ml/m2 (p<0.001).
Conclusions
10-zig CCPs of 7-8 cm appear to provider reliable SVASD closure with a low requirement for additional stents. Careful selection of patients and meticulous attention to detail is required to avoid complications. This article is protected by copyright. All rights reserved.

This article is protected by copyright. All rights reserved.

Catheter Cardiovasc Interv: 27 Apr 2021; epub ahead of print

SCAI Expert Consensus Update on Best Practices in the Cardiac Catheterization Laboratory.

Naidu SS, Abbott JD, Bagai J, Blankenship J, ... Welt FG, Kolansky DM
This update to the SCAI Expert Consensus Statement on Best Practices in the Cardiac Catheterization Laboratory (CCL) builds upon previous statements in 2012 and 2016. Key tenets have remained, including patient-centric approach to the flow of patients through the laboratory, consistency with the requirements of regulatory and accreditation bodies, and contemporary standards incorporating new evidence. This clinical expert consensus statement pertains primarily to diagnostic and therapeutic coronary artery procedures, with somewhat less attention to structural or other procedures. Nonetheless, the general principles established here would apply to most structural and endovascular procedures, and a section on the collaboration with electrophysiology has also been included. Importantly, the purpose of this document is not to represent all acceptable practices, but to provide a consensus on \"best practices\" as goals for CCL. It is anticipated that regulatory bodies, accrediting organizations, hospitals and health systems, CCL directors and managers, as well as hospital administrators will reference this document for process improvement and standardization. Moreover, this document should serve as a guide for new CCLs, including both outpatient (ambulatory) and inpatient facilities. This article is protected by copyright. All rights reserved.

This article is protected by copyright. All rights reserved.

Catheter Cardiovasc Interv: 27 Apr 2021; epub ahead of print

Impact of anemia on short-term outcomes after TAVR: A subgroup analysis from the BRAVO-3 randomized trial.

Razuk V, Camaj A, Cao D, Nicolas J, ... Mehran R, Dangas GD
Objectives
To determine the prognostic impact of anemia in patients randomized to bivalirudin or unfractionated heparin (UFH) during transcatheter aortic valve replacement (TAVR).
Background
Whether the periprocedural use of bivalirudin as compared with UFH in anemic patients undergoing TAVR has an impact on outcomes remains unknown.
Methods
The BRAVO-3 trial compared the use of bivalirudin versus UFH in 802 high risk patients undergoing transfemoral TAVR for severe symptomatic aortic stenosis. Patients were stratified according to the presence (defined as hemoglobin levels <13 g/dL in men and <12 g/dL in women) or absence of anemia. The primary outcomes were net adverse cardiac events (NACE; a composite of all-cause mortality, myocardial infarction, stroke, or bleeding) and major bleeding (BARC ≥3b) at 30 days.
Results
Among 798 patients with available baseline hemoglobin levels, 427 (54%) were anemic of whom 221 (52%) received bivalirudin. There were no significant differences in NACE and major bleeding at 30-days between patients with and without anemia, irrespective of the type of anticoagulant used (p_interaction =0.71 for NACE, p_interaction =1.0 for major bleeding). However, anemic patients had a higher risk of major vascular complications (adjusted OR 2.43, 95% CI 1.42 - 4.16, p=0.001), and acute kidney injury (adjusted OR 1.74, 95% CI 1.16 - 2.59, p=0.007) compared to non-anemic patients at 30-days.
Conclusions
Anemia was not associated with a higher risk of NACE or major bleeding at 30 days after TAVR without modification of the treatment effects of periprocedural anticoagulation with bivalirudin versus UFH. This article is protected by copyright. All rights reserved.

This article is protected by copyright. All rights reserved.

Catheter Cardiovasc Interv: 27 Apr 2021; epub ahead of print

Racial and Ethnic Disparities in Diagnosis, Treatment, and Outcomes of Coronary, Vascular, Structural, and Congenital Heart Disease.

Grines CL, Klein AJ, Bauser-Heaton H, Alkhouli M, ... Sandoval Y, Young MN
Cardiovascular disease (CVD) remains the leading cause of death in the United States (US). However, percutaneous interventional cardiovascular therapies are often underutilized in Blacks, Hispanics, and women and may contribute to excess morbidity and mortality in these vulnerable populations. The Society for Cardiovascular Angiography and Interventions (SCAI) is committed to reducing racial, ethnic, and sex-based treatment disparities in interventional cardiology patients. Accordingly, each of the SCAI Clinical Interest Councils (coronary, peripheral, structural, and congenital heart disease) participated in the development of this whitepaper addressing disparities in diagnosis, treatment, and outcomes in underserved populations. The councils were charged with summarizing the available data on prevalence, treatment, and outcomes and elucidating potential reasons for any disparities. Given the huge changes in racial and ethnic composition by age in the United States (Figure 1), it was difficult to determine disparities in rates of diagnosis and we expected to find some racial differences in prevalence of disease. For example, since the average age of patients undergoing transcatheter aortic valve replacement (TAVR) is 80 years, one may expect 80% of TAVR patients to be non-Hispanic White. Conversely, only 50% of congenital heart interventions would be expected to be performed in non-Hispanic Whites. Finally, we identified opportunities for SCAI to advance clinical care and equity for our patients, regardless of sex, ethnicity, or race. This article is protected by copyright. All rights reserved.

This article is protected by copyright. All rights reserved.

Catheter Cardiovasc Interv: 27 Apr 2021; epub ahead of print

Establishing the optimal duration of DAPT following PCI in high-risk TWILIGHT-like patients with acute coronary syndrome.

Wang HY, Mo R, Guan CD, Wang Y, ... Xu B, Dou KF
Objectives
To determine the association of extended-term (>12-month) versus short-term dual antiplatelet therapy (DAPT) with ischemic and hemorrhagic events in high-risk \"TWILIGHT-like\" patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) in clinical practice.
Background
Recent emphasis on shorter DAPT regimen after PCI irrespective of indication for PCI may fail to account for the substantial residual risk of recurrent atherothrombotic events in ACS patients.
Methods
All consecutive patients fulfilling the \"TWILIGHT-like\" criteria undergoing PCI were identified from the prospective Fuwai PCI Registry. High-risk patients (n = 8,358) were defined by at least one clinical and one angiographic feature based on TWILIGHT trial selection criteria. The primary ischemic endpoint was major adverse cardiac and cerebrovascular events at 30 months, composed of all-cause mortality, myocardial infarction, or stroke while BARC type 2, 3, or 5 bleeding was key secondary outcome.
Results
Of 4,875 high-risk ACS patients who remained event-free at 12 months after PCI, DAPT>12-month compared with shorter DAPT reduced the primary ischemic endpoint by 63% (1.5 vs. 3.8%; HRadj: 0.374, 95% CI: 0.256-0.548; HRmatched: 0.361, 95% CI: 0.221-0.590). The HR for cardiovascular death was 0.049 (0.007-0.362) and that for MI 0.45 (0.153-1.320) and definite/probable stent thrombosis 0.296 (0.080-1.095) in propensity-matched analyses. Rates of BARC type 2, 3, or 5 bleeding (0.9 vs. 1.3%; HRadj: 0.668 [0.379-1.178]; HRmatched: 0.721 [0.369-1.410]) did not differ significantly between two groups.
Conclusions
Among high-risk ACS patients undergoing PCI, long-term DAPT, compared with shorter DAPT, reduced ischemic events without a concomitant increase in clinically meaning bleeding events, suggesting that prolonged DAPT can be considered in ACS patients who present with a particularly higher risk for thrombotic complications without excessive risk of bleeding.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 27 Apr 2021; epub ahead of print

Patients with COVID-19 who experience a myocardial infarction have complex coronary morphology and high in-hospital mortality: Primary results of a nationwide angiographic study.

Abizaid A, Campos CM, Guimarães PO, Costa JR, ... Filho RK, COVID MI investigators
Objectives
We aimed to explore angiographic patterns and in-hospital outcomes of patients with concomitant coronavirus disease-19 (COVID-19) and myocardial infarction (MI).
Background
Patients with COVID-19 may experience MI during the course of the viral infection. However, this association is currently poorly understood.
Methods
This is a multicenter prospective study of consecutive patients with concomitant COVID-19 and MI who underwent coronary angiography. Quantitative and qualitative coronary angiography were analyzed by two observers in an independent core lab.
Results
A total of 152 patients were included, of whom 142 (93.4%) had COVID-19 diagnosis confirmation. The median time between symptom onset and hospital admission was 5 (1-10) days. A total of 83 (54.6%) patients presented with ST-elevation MI. The median angiographic Syntax score was 16 (9.0-25.3) and 69.0% had multi-vessel disease. At least one complex lesion was found in 73.0% of patients, 51.3% had a thrombus containing lesion, and 57.9% had myocardial blush grades 0/1. The overall in-hospital mortality was 23.7%. ST-segment elevation MI presentation and baseline myocardial blush grades 0 or 1 were independently associated with a higher risk of death (HR 2.75, 95%CI 1.30-5.80 and HR 3.73, 95%CI 1.61-8.61, respectively).
Conclusions
Patients who have a MI in the context of ongoing COVID-19 mostly present complex coronary morphologies, implying a background of prior atherosclerotic disease superimposed on a thrombotic milieu. The in-hospital prognosis is poor with a markedly high mortality, prompting further investigation to better clarify this newly described condition.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 26 Apr 2021; epub ahead of print

Overview of the virtual 2020 FDA\'s circulatory system devices advisory panel on Neovasc reducer system.

Medranda GA, Torguson R, Waksman R
Refractory angina is considered a devastating condition with limited medical and therapeutic options. The Neovasc Reducer device, when implanted in the coronary sinus, is designed to alleviate anginal symptoms. However, the available clinical data are sparse. The US Food and Drug Administration (FDA) assembled the Circulatory Systems Devices Panel to discuss the Reducer\'s safety and effectiveness. Because of the coronavirus disease 2019 pandemic, this meeting was held virtually. In this manuscript, we detail the deliberation and discussion among the circulatory panel members, including their final vote.

© 2021 Wiley Periodicals LLC.

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

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: 23 Apr 2021; epub ahead of print

Transcatheter aortic valve implantation for degenerated aortic valves: Experience with a new supra-annular device. The Spanish Allegra valve-in-valve (SAVIV) registry.

Moreno R, Baz JA, Moreu J, Berenguer A, ... Moya H, Lázaro E
Objectives
The objective was to evaluate the results of valve-in-valve procedures performed with the Allegra device.
Background
Transcatheter aortic valve implantation to treat degenerated biological aortic valves (valve-in-valve) is an established procedure in most catheterization laboratories, but the results are poorer than procedures done in native aortic stenosis. The Allegra device (Biosensors, Morges, Switzerland) has an excellent design to treat these patients.
Methods
All patients with severely degenerated biological aortic valve treated with the Allegra device in centers from Spain until December 2020 were included (n = 29). Hemodynamic results and 30-day clinical outcomes were evaluated. The predominant hemodynamic failure was stenosis in 15, regurgitation in 11, and a combination of both in 3 cases. Time from aortic valve replacement to valve-in-valve procedure was 8.4 ± 3.9 years (range 3.3-22.1).
Results
After the procedure, maximum and mean trans-valvular gradients were 17.4 ± 12.3 and 8.4 ± 6.1 mmHg, respectively. Device success was obtained in 28 patients (96.6%). In one patient with a degenerated 19 mm prosthetic valve, mean gradient after the procedure was 22 mmHg. No patients had a para-valvular leak grade >1. There were no deaths during the hospitalization or at 30 days and one patient suffered a stroke.
Conclusions
The Allegra trans-catheter aortic valve offers optimal hemodynamic results in patients with severely degenerated biological aortic valve.

© 2021 Wiley Periodicals LLC.

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

Pressure loss recovery in aortic valve stenosis: Contemporary relevance.

Herrmann HC, Laskey WK
Pressure loss recovery (PLR) is a hydrodynamic phenomenon that occurs when blood flow encounters a narrowing typified by aortic valve stenosis (AS). Multiple factors contribute to the magnitude of PLR including the volumetric rate of flow, the geometry of the entrance to the vena contracta (VC) or point of minimum dimension, including that of the left ventricular outflow tract and valve orifice, and the geometry of the proximal aorta. In the majority of clinical circumstances, PLR results in echocardiographic Doppler gradient estimates that are modestly, but generally not clinically important, greater than those derived from rigorously performed catheter measurements. The contribution of PLR to the echocardiographically-measured gradient may not differ significantly between currently available valve prostheses and is likely to be small in patients with mild AS following TAVR.

© 2021 Wiley Periodicals LLC.

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

Clinical evaluation of the Hydra self-expanding transcatheter aortic valve: 6 month results from the GENESIS trial.

Chandra P, Jose J, Mattummal S, Mahajan AU, ... Mehrotra S, Søndergaard L
Objectives
To evaluate the safety and performance of the Hydra transcatheter aortic valve (THV) in the treatment of symptomatic severe aortic stenosis in patients at high or extreme surgical risk.
Background
The Hydra THV (Vascular Innovations Co. Ltd., Nonthaburi, Thailand) is a novel flexible repositionable self-expanding system with supra-annular bovine pericardial leaflets, available in three sizes, covering aortic annuli between 17 and 27 mm.
Methods
The GENESIS trial was a prospective, multi-center, single-arm, 6 month follow-up study conducted in India. The primary performance endpoint was device success defined as per VARC-II criteria at 30 days. The primary safety endpoint was all-cause mortality at 30 days. All endpoints were adjudicated by an independent clinical events committee.
Results
Forty high-risk patients (74.5 ± 6.7 years, 60% men; STS Score:5.6 ± 4.2%) were enrolled in 11 centres. Device success was achieved in 92.5%. The effective orifice area improved from 0.7 ± 0.2 to 2.3 ± 0.6 cm² at 30 days and to 2.2 ± 0.7 cm² at 6 months (p < .0001). Mean aortic valve gradient decreased from 53.5 ± 18.1 to 8.9 ± 4.9 mmHg at 30 days and to 7.6 ± 2.7 mmHg at 6 months (p < .0001). The rate of new permanent pacemaker implantation was 7.5% at 30 days, and no patient had more than mild paravalvular leak at 6 months. The 30 days and 6 month all-cause mortality was 10.0 and 17.5%, cardiovascular mortality 7.5 and 7.5%, device-related mortality 5.0 and 5.0%, respectively. No patients had stroke up to 6 months.
Conclusions
The GENESIS trial demonstrated high efficacy of the self-expanding Hydra THV. The cardiovascular mortality rate of 7.5% may partly be explained by the inclusion of some centres with no or limited previous experience in transcatheter aortic valve implantation.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 19 Apr 2021; epub ahead of print

Complications and failure modes of coronary embolic protection devices: Insights from the MAUDE database.

Megaly M, Morcos R, Khalil C, Garcia S, ... Alaswad K, Brilakis ES
Background
There is limited data on complications associated with the use of coronary embolic protection devices (EPDs).
Methods
We queried the Manufacturer and User Facility Device Experience database between November 2010 and November 2020 for reports on coronary EPDs: Spider FX (Medtronic, Minneapolis, MN) and Filterwire EZ (Boston Scientific, Natick, MA).
Results
We retrieved 119 reports on coronary EPD failure (Spider FX n = 33 and Filterwire EZ n = 86), most of which (78.2%) occurred during saphenous vein graft interventions. The most common failure mode was inability to retrieve the EPD (49.6%), with the filter trapped against stent struts in 76.2% of the cases. Other device complications included filter fracture (28.6%), failure to cross (7.6%), failure to deploy (7.6%), and failure to recapture the filter (3.4%). Filter fracture (54.5 vs. 29.1%) and failure to recapture (9.1 vs. 2.1%) were more commonly reported, while failure to deploy the filter (0 vs. 10.5%) was less commonly reported with the Spider-FX.
Conclusions
The most common modes of failure of coronary EPDs are the failure of retrieval (49.6%), followed by the filter fracture (28.6%). When using EPDs, careful attention to the technique is essential to avoid failures and subsequent complications.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 19 Apr 2021; epub ahead of print

Variability in reporting of key outcome predictors in acute myocardial infarction cardiogenic shock trials.

Tyler JM, Brown C, Jentzer JC, Baran DA, ... Sharkey SW, Henry TD
Background
Among acute myocardial infarction patients with cardiogenic shock (AMICS), a number of key variables predict mortality, including cardiac arrest (CA) and shock classification as proposed by Society for Cardiovascular Angiography and Intervention (SCAI). Given this prognostic importance, we examined the frequency of reporting of high risk variables in published randomized controlled trials (RCTs) of AMICS patients.
Methods
We identified 15 RCTs enrolling 2,500 AMICS patients and then reviewed rates of CA, baseline neurologic status, right heart catheterization data, lactate levels, inotrope and vasopressor requirement, hypothermia, mechanical ventilation, left ventricular ejection fraction (LVEF), mechanical circulatory support, and specific cause of death based on the primary manuscript and Data in S1.
Results
A total of 2,500 AMICS patients have been enrolled in 15 clinical trials over 21 years with only four trials enrolling >80 patients. The reporting frequency and range for key prognostic factors was: neurologic status (0% reported), hypothermia (28% reported, prevalence 33-75%), specific cause of death (33% reported), cardiac index and wedge pressure (47% reported, range 1.6-2.3 L min^-1 m^-2 and 15-24 mmHg), lactate (60% reported, range 4-7.7 mmol/L), LVEF (73% reported, range 25-45%), CA (80% reported, prevalence 0-92%), MCS (80% reported, prevalence 13-100%), and mechanical ventilation (93% reported, prevalence 35-100%). This variability was reflected in the 30-day mortality which ranged from 20-73%.
Conclusions
In a comprehensive review of seminal RCTs in AMICS, important predictors of outcome were frequently not reported. Future efforts to standardize CS trial data collection and reporting may allow for better assessment of novel therapies for AMICS.

© 2021 Wiley Periodicals LLC.

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

Is the effect of atorvastatin 60 mg on stabilization of lipid-rich plaque equivalent to that of rosuvastatin 10 mg? A serial optical coherence tomography combined with intravascular ultrasound imaging.

Xu M, Demuyakor A, Hu S, Liu H, ... Zhang S, Yu B
Objectives
This study aimed to compare the effect of atorvastatin 60 (AT60) mg to that of rosuvastatin 10 (RT10) mg on the morphological changes in lipid-rich plaques (LRPs) and plaque volume, using serial optical coherence tomography (OCT) and intravascular ultrasound imaging (IVUS).
Background
Intensive lipid lowering therapy by statin provides more clinical benefit compared to that of moderate lipid lowering therapy.
Methods
Fifty patients who underwent OCT and IVUS at baseline, 6, and 12 months were grouped by statin therapy into the AT60 mg (n = 27) and RT10 mg (n = 23) groups. The relationships between absolute and percentage changes in biomarkers and fibrous cap thickness (FCT) during follow-up were investigated using a simple regression analysis.
Results
At 6 months, the mean low-density lipoprotein cholesterol level reduced from 113.5 to 65.5 mg/dl (AT60 mg group) and 100.2 to 72.2 mg/dl (RT10 mg groups). A continuous increase in FCT from baseline to 12 months was observed in both groups (p < .001, p < .001, respectively). Mean lipid arc significantly decreased in both AT60 mg (189.0 ± 55.9°, 170.9 ± 60.2°, 155.6 ± 50.6°, p < .001) and RT10 mg (160.0 ± 45.6°, 151.2 ± 48.5°, 141.1 ± 52.9°, p = .010) groups. Plaque burden did not change significantly in both groups.
Conclusions
Lipid-lowering therapy effect with AT60 mg was equivalent to that of RT10 mg in terms of change in plaque morphology. AT60 mg showed more intensive low-density lipid cholesterol level reduction compared to RT10 mg while RT10 mg was effective in increasing the high-density lipid cholesterol level. Both statin therapies could effectively stabilize LRPs.

© 2021 Wiley Periodicals LLC.

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

In-hospital outcomes and usage of embolic protection devices in percutaneous coronary intervention for coronary artery bypass grafts: Insights from a Japanese nationwide registry.

Oba Y, Inohara T, Takahashi M, Fukutomi M, ... Ikari Y, Kario K
Objectives
We evaluated the in-hospital outcomes of percutaneous coronary intervention (PCI) for bypass graft vessels (GV-PCI) compared with those of PCI for native vessels (NV-PCI) using data from the Japanese nationwide coronary intervention registry.
Methods
We included PCI patients (N = 748,229) registered between January 2016 and December 2018 from 1,123 centers. We divided patients into three groups: GV-PCI (n = 2,745); NV-PCI with a prior coronary artery bypass graft (pCABG) (n = 23,932); and NV-PCI without pCABG (n = 721,552).
Results
GV-PCI implementation was low, and most cases of PCI in pCABG patients were performed in native vessels (89.7%) in contemporary Japanese practice. The risk profile of patients with pCABG was higher than that of those without pCABG. Consequently, GV-PCI patients had a significantly higher in-hospital mortality than NV-PCI patients without pCABG after adjusting for covariates (odds ratio [OR] 2.36, 95% confidence interval [CI] 1.66-3.36, p < .001). Of note, embolic protection devices (EPDs) were used in 18% (n = 383) of PCIs for saphenous vein grafts (SVG-PCI) with a significant variation in its use among institutions (number of PCI: hospitals that had never used an EPD vs. EPD used one or more times = 240 vs. 345, p < .001). The EPDs used in the SVG-PCI group had a significantly lower prevalence of the slow-flow phenomenon after adjusting for covariates (OR 0.45, 95% CI 0.21-0.91, p = .04).
Conclusion
GV-PCI is associated with an increased risk of in-hospital mortality. EDP use in SVG-PCI was associated with a low rate of the slow-flow phenomenon. The usage of EPDs during SVG-PCI is low, with a significant variation among institutions.

© 2021 Wiley Periodicals LLC.

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

Trends and causes of readmission following peripheral vascular intervention in patients with peripheral vascular disease.

Moussa Pacha H, Mir T, Al-Khadra Y, Sattar Y, ... Hakim Z, Alraies MC
Objectives
To study the risk factors associated with 30-readmission postperipheral vascular intervention (PVI) in peripheral artery disease (PAD).
Background
There has been a paucity of data regarding the trend and predictors of PVI readmission.
Methods
We performed an observational cohort study of patients admitted with peripheral vascular disease for PVI using the NRD for the years 2010-2014. PVI was defined as angioplasty, atherectomy, and/or stenting of lower limb vessels.
Results
A total of 453,278 patients (30-day readmission n = 97,235). The mean age of study population was 68.6 ± 12.2 years and included 43.8% women. The 30-day readmission post-PVI (p = .034). Cardiovascular causes constitute 44% of readmission. Chronic limb ischemia and intermittent claudication were two most common cardiovascular causes constituting 11.7 and 4.9% cases of readmissions. Other cardiac causes of readmissions included heart failure (4.64%), dysrhythmias (1.4%), and acute myocardial infarction (1.7%). The high-risk factors for of all-cause 30-day readmission were hypertension, CLI, diabetes, renal failure, dyslipidemia, smoking, chronic pulmonary disease, and atrial fibrillation (p < .005). Length-of-stay was greater than 5 days for 56.2 and 75.4% paid by Medicare.
Conclusions
Our study shows an average yearly readmission rate of 21.5% post-PVI. Chronic comorbidities, prolonged hospitalization was associated with higher risk of 30-day readmission.

© 2021 Wiley Periodicals LLC.

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

Heart valve sizing and clinical outcomes in patients undergoing transcatheter aortic valve implantation.

Okuno T, Heg D, Lanz J, Praz F, ... Windecker S, Stortecky S
Objectives
To investigate the impact of transcatheter heart valve (THV) sizing on procedural results and clinical outcomes following transcatheter aortic valve implantation (TAVI).
Background
The impact of individual THV sizing for patients with borderline aortic annulus anatomy remains unclear.
Methods
In the prospective BernTAVI registry, THV sizing conditions were retrospectively evaluated, and patients were categorized into three groups based on the recommendations and the sizing chart of the manufacturers: optimal sizing, borderline sizing (THV size located within 5% to each border of the optimal sizing recommendation), and suboptimal sizing (THV size outside the recommended range). The latter two groups were further subcategorized into THV-oversizing and THV-undersizing. The primary endpoint was a composite of all-cause death and unplanned repeat intervention at 1 year.
Results
Out of a total of 1,638 patients who underwent TAVI, 9.5 and 15.6% of patients were categorized into the borderline and suboptimal sizing group, respectively. Device success was achieved in 87.4, 88.9, and 83.6% of patients with optimal, borderline, and suboptimal sizing, respectively. The primary endpoint occurred in 12.3% of patients with optimal sizing, 14.9% of patients with borderline sizing (HR_adj 1.35, 95%CI 0.87-2.09), and in 17.4% of patients with suboptimal sizing (HR_adj 1.42, 95%CI 1.01-1.99). Within the suboptimal sizing cohort, unfavorable outcomes were mainly associated with THV undersizing (device success: 76.4%, primary endpoint: 23.9%, HR_adj 1.98, 95%CI 1.36-2.87).
Conclusion
Suboptimal TAVI prosthesis sizing is associated with an increased risk of all-cause death and unplanned repeat intervention within 1 year largely attributable to undersized THV prostheses.

© 2021 Wiley Periodicals LLC.

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

Successful radiofrequency perforation and balloon decompression of cor triatriatum sinister using novel technique, a case series.

Blais BA, Aboulhosn JA, Salem MM, Levi DS
Cor triatriatum sinister (CTS) is a rare congenital cardiac anomaly representing <0.1% of all congenital cardiac malformations. It is characterized by the presence of a left atrial (LA) membrane that leads to left ventricular inflow obstruction. Uncorrected, obstructed CTS may have significant sequelae such as pulmonary hypertension or arrhythmias. Transcatheter balloon decompression has been described as a successful alternative to surgical resection of the obstructing membrane. Our review of the literature revealed no reported cases utilizing radiofrequency (RF) energy to perforate the CTS membrane prior to balloon decompression. This manuscript describes two patients with CTS who were treated successfully with a transcatheter technique using RF energy to perforate the obstructing membrane prior to balloon angioplasty and decompression of the LA.

© 2021 Wiley Periodicals LLC.

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

In-hospital outcomes after transcatheter edge-to-edge mitral valve repair in patients with chronic kidney disease: An analysis from the 2010-2016 National inpatient sample.

Panchal HB, Stone GW, Saxena A, Bursac Z, ... Leon MB, Beohar N
Objectives
To assess the outcomes following transcatheter edge-to-edge mitral valve repair (TMVr) in patients with chronic kidney disease (CKD).
Background
Percutaneous TMVr is beneficial in high surgical risk patients with severe mitral regurgitation (MR). However, those with CKD are not well studied.
Methods
Utilizing the International Classification of Disease (ninth and tenth revision, clinical modification codes) and the Nationwide Inpatient Sample database, we identified 9,228 patients who underwent TMVr during 2010-2016, including those with no or mild CKD (group 1, n = 6,654 [72.11%]), moderate or severe CKD (group 2, n = 2,125 [23.03%]) and end-stage renal disease (ESRD) on dialysis (group 3, n = 449 [4.86%]). In-hospital clinical outcomes, length of stay and cost were assessed.
Results
In-hospital mortality increased numerically as CKD severity increased, but not statistically different between groups (1.8, 3.3, and 4.5% respectively in group 1, 2, and 3, p = .07). Moderate to severe CKD (group 2) was an independent predictor of acute renal failure requiring hemodialysis (ARFD) (OR: 3.51, CI: 2.33-5.28, p < .0001), the composite outcome of death, ARFD or stroke [OR: 3.15, 95% CI: 2.10-4.76, p < .0001] and extended length of stay [OR: 1.73, 95% CI: 1.24-2.42), p = .001] while ESRD (group 3) was an independent predictor of higher hospital cost [OR: 1.66, 95% CI: 1.01-2.74), p = .04] as compared with no or mild CKD (group 1).
Conclusions
High surgical risk patients with severe MR commonly have associated comorbidities including CKD. TMVr outcomes appear to worsen with worsening CKD and therefore careful clinical case selection and further studies evaluating TMVr outcomes in CKD patients is warranted.

© 2021 Wiley Periodicals LLC.

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

Association of acute kidney injury with outcomes in patients undergoing percutaneous left atrial appendage closure.

Nazir S, Ahuja KR, Ariss RW, Hassanein M, ... Moukarbel GV, Jneid H
Objectives
Using a large nationally representative database, we aimed to examine risk factors for acute kidney injury (AKI) and its association with outcomes in patients undergoing percutaneous left atrial appendage closure (LAAC).
Background
Previous small-scale studies have reported poor outcomes with AKI following percutaneous LAAC.
Methods
We queried the Nationwide Readmission Database to identify LAAC procedures performed from 2016 to 2017. Multivariable logistic and linear regression models were used to identify risk factors for AKI and determine the association between AKI and clinical outcomes. The primary outcome of interest was in-hospital mortality.
Results
Of 20,703 patients who underwent LAAC during the study period, 1,097 (5.3%) had a diagnosis of AKI. Chronic kidney disease, non-elective admission, coagulopathy, weight loss, prior coronary artery disease, heart failure, diabetes mellitus, and anemia were independently associated with an increased risk of AKI after LACC. In patients undergoing LAAC, AKI was associated with an increased risk of in-hospital mortality (adjusted odds ratio [aOR], 16.01; 95% CI, 8.48-30.21), stroke/transient ischemic attack (aOR, 2.50; 95% CI, 1.69-3.70), systemic embolization (aOR, 3.78; 95% CI, 1.64-8.70), bleeding/transfusion (aOR, 1.96; 95% CI, 1.50-2.56), vascular complications (aOR, 3.53; 95% CI, 1.94-6.42), pericardial tamponade requiring intervention (aOR, 6.83; 95% CI, 4.37-10.66), index length of stay (adjusted parameter estimate, 7.46; 95% CI, 7.02-7.92), and 180-day all-cause readmissions (aOR, 1.43; 95% CI, 1.09-1.88).
Conclusion
AKI in the setting of LAAC is uncommon but is associated with poor clinical outcomes. Further studies are needed to determine if a similar association exists for long-term outcomes.

© 2021 Wiley Periodicals LLC.

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

Percutaneous mitral valve repair with MitraClip device in hemodynamically unstable patients: A systematic review.

Martinez-Gomez E, McInerney A, Tirado-Conte G, de Agustin JA, ... Macaya C, Nombela-Franco L
Background
Very few data exist on percutaneous mitral valve repair (PMVr) in unstable patients with concomitant moderate-severe mitral regurgitation (MR). The purpose of this systematic review was to evaluate baseline characteristics, management and clinical outcomes of critically ill patients undergoing PMVr with MitraClip.
Methods
We conducted a systematic review of the published data on MitraClip from its first use in 2003 to December 2020. Studies referring to critically ill patients in cardiogenic shock or acute refractory pulmonary edema were included. A total of 40 publications including 254 patients with significant MR (Grade 4 in 91%) were included.
Results
Mean age was 70 ± 12 years with mean Euroscore II and STS of 21 ± 13 and 20.5 ± 16, respectively. Clinical presentation was with cardiogenic shock and acute myocardial infarction in 72.8 and 60.0% of patients, respectively. Device success was achieved in 238 (93.7%) patients with a significant reduction in MR (Grade ≤ 2 in 91.8%, p < .001). The median weaning time from the procedure, to discontinuation of mechanical circulatory or respiratory support, was 2 days (IQR 1-4), with an in-hospital mortality and non-fatal complication rate of 12.6 and 9.1%, respectively. Kaplan-Meier curves estimated an overall mortality rate of 39.1% at 12-month follow-up, with persistent reduction in MR severity for survivors (Grade ≤ 2 in 81.3%) and one case of mitral valve reintervention.
Conclusions
Percutaneous mitral valve repair with MitraClip device is a technically feasible and potentially viable management option in high-risk patients with cardiogenic shock or refractory pulmonary edema and concomitant moderate-severe MR. Prospective trials are required to confirm these findings, and definitively determine the value of MitraClip in hemodynamically unstable patients.

© 2021 Wiley Periodicals LLC.

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

Coronary sinus size and ischemia improvement after reducer implantation; \"one size to fit them all?\"

Tzanis G, Khokhar AA, Ponticelli F, Gallone G, ... Colombo A, Giannini F
Aim
Coronary sinus (CS) reducer implantation is associated with symptomatic relief of patients with refractory angina. However, 15% to 30% of the patients do not respond to this treatment. Aim if this study was to evaluate the effect of CS size in the effectiveness of the device.
Methods
Prior to device implantation and at 4-month resting ventricular function was assessed by stress cardiac magnetic resonance. Ischemia was assessed by the myocardial perfusion reserve index (MPRI).
Results
Fifteen patients (66 ± 10 years) underwent successful CS Reducer implantation, with improvements in angina class and exercise tolerance. Patients with a smaller CS size (<5.8 mm) presented a significantly higher percentage increase in MPRI (63 ± 51 vs 9 ± 30%, P = .03) and a higher reduction in left ventricle end-diastolic volumes.
Conclusions
Greater benefits, in terms of ischemia improvement, after CS Reducer implantation were seen in patients with smaller CS sizes, suggesting a potential mechanism underlying the observed rates of reducer non-responsiveness.

© 2021 Wiley Periodicals LLC.

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

Right ventricular outflow tract stenting in symptomatic infants without the use of a long delivery sheath.

Linnane N, Nasef MA, McMahon CJ, McGuinness J, ... Walsh KP, Kenny D
Background:
and objectives
Right ventricular outflow tract (RVOT) stenting improves systemic oxygenation and facilitates pulmonary arterial growth in symptomatic infants prior to repair of tetralogy of Fallot. The aim of this study was to evaluate the safety and efficacy of RVOT stenting without the use of a long delivery sheath.
Methods
Retrospective data analysis of patients under 1 year of age undergoing RVOT stenting from January 2010 to January 2020 at a single tertiary pediatric cardiology center.
Results
Sixty-three RVOT stents were deployed during 53 procedures into 44 patients. The median age and weight at insertion were 41 days (range 2-204) and 3.6 kg (range 1.59-7) respectively. Thirty-one procedures were semi-elective and 22 were emergencies. Stent positioning was guided by transthoracic echocardiogram and/or RV angiography from a pigtail micro-catheter placed via the aorta. The median total procedure and fluoroscopy times were 67.5 (range 15-145) and 19 min (1-107), respectively. The median length of hospital stay was 7 days (range 1-258). Twenty-one patients were admitted to ICU post-procedure with a median ICU length of stay of 3 days (range 3-11). There were three major complications including two deaths within 30 days of the procedure. A patient with Cornelia de Lange Syndrome (1.8 kg) died following stent migration and inability to wean from emergency cardiopulmonary bypass and the second infant had an unexplained asystolic arrest post-procedure while awaiting transfer to ICU.
Conclusions
RVOT stenting is technically possible with minimal complications without the need for a long delivery sheath. Additional imaging with transthoracic echocardiography can facilitate the safe deployment of the stent.

© 2021 Wiley Periodicals LLC.

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

Reduction of MANTA-associated vascular complications after implementation of key insights on failure mechanisms.

Moccetti F, Wolfrum M, Bossard M, Attinger-Toller A, ... Kobza R, Toggweiler S
Objectives
Report MANTA-associated vascular complications after implementation of key insights on failure mechanisms.
Background
The MANTA vascular closure device is utilized to close large-bore arterial access sites. We have previously identified and published the mechanisms and predictors of MANTA-associated vascular complications. We identified three distinct mechanisms leading to MANTA-associated vascular complications, predictors were a common femoral artery (CFA) diameter <6 mm and clinically established peripheral artery disease (PAD).
Methods
We compared 100 consecutive patients of the initial cohort (first n = 100) with consecutive patients in which the key insights acquired in the initial cohort were implemented (second n = 100).
Results
The initial cohort (n = 100 patients) had a MANTA-related vascular complication rate of 11% (7% major and 4% minor), and 14% MANTA-related bleeding complications. In a subsequent cohort of n = 100 patients, we applied the abovementioned findings: we did not use the MANTA device if the CFA was <6 mm and in patients with PAD. In addition, femoral puncture was ultrasound guided. This strategy led to a decline in MANTA-related vascular complication rates: 2% (1% major and 1% minor) p = .03, as well as a reduction in MANTA-related bleeding complications to 5% p = .01. To the best of our knowledge, this is the lowest rate of MANTA-related vascular complication reported thus far.
Conclusions
Our strategy achieves low MANTA-related vascular and bleeding complication rates. Careful and critical examination of complications can lead to rapid identification of complication mechanism and its predictors. In turn, rapid implementation of these insights can lead to a decline in complication rates.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 12 Apr 2021; epub ahead of print

Long-term outcomes of self-expanding versus balloon-expandable transcatheter aortic valves: Insights from the OBSERVANT study.

Costa G, D\'Errigo P, Rosato S, Valvo R, ... Barbanti M, OBSERVANT Research Group
Objectives
To compare clinical outcomes of balloon-expandable (BE) and self-expanding (SE) transcatheter aortic valves (TAVs) up to 5 years.
Background
To date, no robust, comparative data of BE and SE TAVs at long-term are available.
Methods
We considered a total of 1,440 patients enrolled in the multicenter OBSERVANT study and undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI) with either supra-annular SE (n = 830, 57.6%) and intra-annular BE (n = 610, 42.4%) valves. Clinical outcomes of the two groups were compared after adjustment using inverse probability of treatment weighting (IPTW) and confirmed by sensitivity analysis with propensity score matching.
Results
Patients receiving SE valve showed a higher all-cause mortality at 5 years (Kaplan-Meier estimates 52.3% vs. 47.7%; Hazard ratio [HR] 1.18, 95% confidence interval [CI] 1.01-1.38, p = .04). Landmark analyses showed that there was a not statistically significant reversal of risk excess against the BE group starting from 3 years after TAVI (3-5 years HR 0.97, 95% CI 0.76-1.25, p = .86). Post-procedural, moderate/severe paravalvular regurgitation (PVR)(HR 1.46, 95% CI 1.14-1.87; p < .01) and acute kidney injury (AKI)(HR 3.89, 95% CI 2.47-6.38; p < .01) showed to be independent predictors of 5-year all-cause mortality in multivariable analysis.
Conclusions
Considering the intrinsic limitations of the OBSERVANT study, we found that patients undergoing TF-TAVI with a supra-annular SE valve had a higher all-cause mortality compared to those receiving an intra-annular BE valve at 5 years. A late catch up phenomenon of patients receiving the BE valve was observed beyond 3 years. Post-procedural moderate/severe PVR seems to play a crucial role in determining this finding. Comparative studies of new generation devices with longer follow-up are needed to evaluate the benefit of each specific TAV type.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 12 Apr 2021; epub ahead of print

Initial experience with the fourth generation MitraClip™: Outcomes, procedural aspects, and considerations for device selection.

Garcia-Sayan E, Raghunathan D, Li FM, Dhoble A, ... Smalling RW, Mackensen GB
Objectives
We present our initial experience with the fourth-generation MitraClip™ (G4) system and propose preliminary criteria for device selection.
Background
The MitraClip™ G4 system recently underwent a \"controlled release\" for transcatheter edge-to-edge mitral valve repair. The four new devices include technical improvements such as controlled gripper actuation (independent leaflet capture) and continuous left atrial pressure monitoring. To date, a patient-specific device selection algorithm, and the technology\'s impact on procedural times and success, have not been described.
Methods
We present an initial multi-center experience and short-term outcomes with the new system, suggest procedural and imaging considerations, and propose initial guidance for device selection.
Results
Sixty-one procedures performed by three operators at two centers between November 2019 and May 2020 were analyzed. At 30-day follow-up, there were three deaths (4.9%), four neurological events (6.6%), and seven re-hospitalizations (11.5%). Fifty-nine patients achieved device and procedural success (96.7%), and there was one device-related technical issue (1.6%). Compared to the same operators utilizing the third generation MitraClip™, the G4 system resulted in a significant reduction in the median number of clips used per patient (1 IQR 1-2 vs. 2 IQR 1-3, p = .023) and a trend toward shorter device times.
Conclusion
Based on our initial experience, we found that the MitraClip™ G4 system is associated with high procedural success and fewer devices needed per procedure. The expanded device options may allow a more targeted approach to the myriad of pathologic presentations of mitral regurgitation. This early experience should provide a foundational opportunity for further refinement.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 12 Apr 2021; epub ahead of print

Transradial approach for carotid artery stenting: A position paper from the Italian Society of Interventional Cardiology (SICI-GISE).

Montorsi P, Cortese B, Cernetti C, Lanzellotti D, ... Marchese A, Cremonesi A
Carotid artery stenting (CAS) is a valid and effective alternative to endoatherectomy when performed by experienced operators. The conventional approach used is the transfemoral one, but in the last 10 years a transradial (TR) approach, the standard access for cardiac catheterization, became widely adopted for peripheral vascular interventions, included the extracranial carotids. Preliminary experiences suggest this approach as safe and effective, especially in specific anatomical and clinical settings that have been shown to be associated with high risk of complications from the femoral route. Lacking international guidelines, this document, promoted by the Italian Society of Interventional Cardiology - Gruppo Italiano Studi Emodinamici (SICI-GISE), was drawn-up by a panel of interventional cardiologists with a documented experience on the subject, focusing on the indications, techniques and materials that should be used for this type of intervention and the most recent literature on the subject.

© 2021 Wiley Periodicals LLC.

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

Predictors and potential advantages of PERT and advanced therapy use in acute pulmonary embolism.

Parikh M, Chahine NM, Hammad TA, Tefera L, ... Schilz R, Shishehbor MH
Objectives
We sought to examine predictors of pulmonary embolism response team (PERT) utilization and identify those who could benefit from advanced therapy.
Background
PERT and advanced therapy use remain low. Current risk stratification tools heavily weight age and comorbidities, which may not always correlate with presentation\'s severity.
Methods
We prospectively studied patients with CT-confirmed PE between January 2019 and December 2019 at our hospital. PERT activation was left to the treating physician. Multivariable analyses were utilized to identify predictors of PERT activation and advanced therapy. Using the log odd ratio of each significant predictor of advanced therapy, we created a scoring system and a score of 2 was associated with the highest use. Primary outcomes were 30- and 90-day all-cause mortality, readmission, and major bleed.
Results
Of the 307 patients, PERT was activated in 22.5%. While abnormal vital signs and right ventricular (RV) strain were associated with PERT activation, pulmonary embolism severity index (PESI) was not. Advanced therapy use was significantly higher in the PERT cohort (35% vs 2%). Predictors of advanced therapy use were composite variable (heart rate > 110 or systolic blood pressure < 100 or respiratory rate > 30 or oxygen saturation < 90%) and right-to-left ventricular ratio > 0.9. PERT patients with advanced therapy use, when compared to the no-PERT patients who could have qualified (score of 2), had significantly lower 30- and 90-day mortality and 30-day readmission without difference in major bleed.
Conclusion
PERT has important therapeutic impact, yet no guidelines to direct activation. We recommend a multidisciplinary approach for higher acuity pulmonary embolism cases and physician education regarding PERT and the scope of advanced therapy use.

© 2021 Wiley Periodicals LLC.

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

Changes in surgical revascularization strategy after fractional flow reserve.

Fournier S, Toth GG, De Bruyne B, Kala P, ... Pellicano M, Barbato E
Aims
In the randomized GRAFFITI trial, surgeons drew their strategy based on coronary angiography. When patients were randomized to fractional flow reserve (FFR)-guidance, surgeons were informed of the FFR values and asked to redraw their strategy. The aim of this study was to investigate the changes induced by FFR knowledge.
Methods and results
The intended and performed strategy (before and after FFR) were compared. Among 172 patients, 84 with 300 lesions were randomized to the FFR-guided group. The intended strategy was to bypass 236 stenoses:108 with a venous and 128 with an arterial graft. After disclosing FFR, a change in strategy occurred in 64 lesions (21.3%) of 48 (55%) patients. Among 64 lesions for which the intended strategy was medical therapy, 16 (25%) were bypassed after disclosing FFR. The number of procedures with >1 venous graft planned was significantly reduced from 37 to 27 patients (p = .031). The proportion of on-pump surgery was significantly reduced from 71 to 61 patients (p = .006). The rates of clinical events at 1 year were similar between patients with or without at least one change in strategy.
Discussion
FFR-guided CABG is associated with a simplified surgical procedure in 55% of the patients, with similar clinical outcomes.

© 2021 Wiley Periodicals LLC.

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

Multicenter and all-comers validation of a score to select patients for manual thrombectomy, the DDTA score.

Cordero A, Cid-Alvarez B, Alegría E, Fernández-Cisnal A, ... Bertomeu-Gonzalez V, Ferreiro JL
Background
Routine manual thrombectomy (MT) is not recommended in primary percutaneous coronary intervention (P-PCI) but it is performed in many procedures. The objective of our study was validating the DDTA score, designed for selecting patients who benefit most from MT.
Methods
Observational and multicenter study of all consecutive patients undergoing P-PCI in five institutions. Results were compared with the design cohort and the performance of the DDTA was analyzed in all patients. Primary end-point of the analyses was TIMI 3 after MT; secondary endpoints were final TIMI 3, no-reflow incidence, in-hospital mortality and in-hospital major cardiovascular events (MACE). In-hospital prognosis was assessed by the Zwolle risk score.
Results
Three hundred forty patients were included in the validation cohort and no differences were observed as compared to the design cohort (618 patients) except for lower use of MT and higher IIb/IIIa inhibitors or drug-eluting stents. The probability of TIMI 3 after MT decreased as delay to P-PCI was higher. If DDTA score, MT was associated to TIMI 3 after MT (OR: 4.11) and final TIMI 3 (OR: 2.44). There was a linear and continuous relationship between DDTA score and all endpoints. DDTA score ≥ 4 was independently associated to lower no-reflow, in-hospital MACE or mortality. The lowest incidence of in-hospital mortality or MACE was in patients who had DDTA score ≥ 4 and Zwolle risk score 0-3.
Conclusions
MT is associated to higher rate of final TIMI3 in patients with the DDTA score ≥ 4. Patients with DDTA score ≥ 4 had lower no-reflow and in-hospital complications.

© 2021 Wiley Periodicals LLC.

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

Incidence and outcomes of acute kidney injury stratified by cardiogenic shock severity.

Padkins M, Breen T, Van Diepen S, Barsness G, Kashani K, Jentzer JC
Background
Acute kidney injury (AKI) is common among patients with cardiogenic shock (CS) and it is independently associated with mortality. We sought to assess the prevalence, severity, and prognosis of AKI as a function of cardiogenic shock severity in unselected Cardiac Intensive Care Unit (CICU) patients.
Methods
We retrospectively reviewed admissions to the Mayo Clinic between 2007 to 2015 and stratified patients by the AKI stage (based on modified Kidney Disease: Improving Global Outcomes criteria) and Society for cardiovascular angiography and interventions (SCAI) shock stage. The association with in-hospital mortality was analyzed using multivariable logistic regression.
Results
We included 9,311 unique patients with a mean age of 67 years and 37% females. SCAI shock stages A, B, C, D, and E were present in 47%, 30%, 15%, 7%, and 1% of patients. The incidence of AKI of any severity was 39% in the CICU and 51% during the hospitalization. Hospital mortality occurred in 8% of all patients, and the risk increased as a function of the rising AKI and SCAI shock stage. Worsening AKI stage was associated with increased adjusted hospital mortality (adjusted OR per AKI stage 1.22, 95% CI 1.10-1.36, p < .001). Higher AKI stages were associated with increased adjusted hospital mortality in SCAI stage A/B (p < .001), but not in SCAI stage C, D, or E (all p > .05).
Conclusions
Higher AKI stages were independently associated with mortality in CICU patients after accounting for shock severity and may add incremental prognostic utility in patients with lower SCAI stages.

© 2021 Wiley Periodicals LLC.

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

End-stage renal disease patients undergoing angioplasty and bypass for critical limb ischemia have worse outcomes compared to non-ESRD patients: Systematic review and meta-analysis.

Dawson DB, Telles-Garcia NA, Atkins JL, Mina GS, ... Virk CS, Dominic PS
Background
End-stage renal disease (ESRD) is associated with increased morbidity and mortality following lower extremity amputation for critical limb ischemia (CLI). Angioplasty and bypass are used in ESRD patients with CLI; however, the treatment of choice remains controversial. We compared the long-term outcomes in patients with CLI undergoing angioplasty or bypass to evaluate the differences between patients with ESRD and those without ESRD.
Methods
Established databases were searched for observational studies comparing outcomes following bypass or angioplasty for CLI in patients with ESRD to those in non-ESRD patients. End points included survival, limb salvage, amputation-free survival (AFS), and primary and secondary patency at 1-year post-procedure. Pooled odds ratios (OR) with 95% confidence intervals (CI) were calculated using a random effect model.
Results
We included 20 studies with a total of 24,851 patients. ESRD patients compared to non-ESRD patients with CLI had significantly lower survival post-angioplasty (OR 0.51, 95% CI 0.36-0.72, p < .001) and post-bypass (OR 0.26, 95% CI 0.15-0.45, p < .001). ESRD patients had lower rates of limb salvage post-bypass (OR 0.33, 95% CI 0.21-0.53, p < .001) and post-angioplasty (OR 0.54, 95% CI 0.41-0.70, p < .001). AFS was significantly lower in ESRD patients compared to non-ESRD patients following angioplasty (OR 0.48, 95% CI 0.32-0.71, p < .001) and bypass (OR 0.28, 95% CI 0.16-0.47, p < .001) despite no significant differences in primary patency. ESRD patients had overall worse secondary patency post-angioplasty and/or bypass (OR 0.54, 95% CI 0.32-0.94, p = .03) compared to non-ESRD patients. A meta-analysis of four studies directly comparing survival in ESRD patients with CLI based on whether they underwent angioplasty or bypass showed no difference (OR 0.93, 95% CI 0.64-1.35, p = .69).
Conclusion
ESRD patients have worse survival, limb salvage, and AFS outcomes following angioplasty and bypass for CLI compared to non-ESRD patients. Large randomized controlled trials comparing these two modalities of treatment in this patient population are needed for further clarity.

© 2021 Wiley Periodicals LLC.

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

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: 05 Apr 2021; epub ahead of print

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: 05 Apr 2021; epub ahead of print

Readmission following urgent transcatheter aortic valve implantation versus urgent balloon aortic valvuloplasty in patients with decompensated heart failure or cardiogenic shock.

Chakraborty S, Patel N, Bandyopadhyay D, Hajra A, ... Abbott JD, Naidu SS
Background
Urgent transcatheter aortic valve implantation (TAVI) is a feasible option for aortic stenosis (AS) patients with decompensated heart failure (HF) and cardiogenic shock (CS) as compared to the more traditional urgent balloon aortic valvuloplasty (BAV).
Objectives
We conducted a retrospective analysis to compare risk and cause of readmission in these two high-risk groups.
Methods
Nationwide Readmission Database (NRD) 2011-2014 was retrospectively analyzed to identify patients with AS having either urgent TAVI or urgent BAV using appropriate ICD-9 codes. Propensity scores were used to match patients with urgent TAVI as compared to patients with urgent BAV. Statistical analysis was performed using the Stata 15.1 software.
Results
We identified a weighted sample of 6,670 patients with urgent BAV and 6,964 patients with urgent TAVI. The all-cause 30- and 90-day readmission was lower in the urgent TAVI group compared to urgent BAV (15.4 vs. 22.5%, (aHR): 0.92 [0.90-0.95] p < .001). 30-day readmission due to CV cause and HF was also lower in the urgent TAVI group (aHR, 0.93: p < .001 and aHR, 0.98: p = .040, respectively). The 30-day gastrointestinal (GI) bleed readmission rate was three times higher in urgent TAVI group (aHR, 3.00:95% CI (1.23-7.33), p = .016), but was not statistically significant at 90-days. Cardiac causes of readmission were the predominant cause of readmission in both groups, but more pronounced in urgent BAV group (60.3 vs. 40.5%, p < .001).
Conclusion
Urgent TAVI appears beneficial in patients with AS and decompensated HF or CS driven by roughly 10 and 25% reductions in overall readmissions at 30 and 90 days, and marked reductions in reintervention, although offset partially by higher risk of readmission due to GI bleeding at 30 days.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 04 Apr 2021; epub ahead of print

The validation of the dual antiplatelet therapy score in East Asians receiving percutaneous coronary intervention with exclusively second generation drug-eluting stents.

Kim M, Park KW, Lee HS, Ki YJ, ... Koo BK, Kim HS
Objectives
We investigated whether the dual antiplatelet therapy (DAPT) score (DS) predicts clinical outcome in an East-Asian population that received exclusively second generation drug-eluting stent (DES).
Backgrounds
It is uncertain whether the DS could adequately risk stratify patients exclusively receiving second generation DES.
Methods
From the Grand-DES registry, we evaluated patients who were treated with DAPT for at least 12 months and were event-free at 12 months after DES implantation. Patients were classified into two categories: high DS (≧2) (n = 3,157); and low DS (<2) (n = 5,226). The primary ischemic outcome was a composite of stent thrombosis and all myocardial infarction (MI), and the primary bleeding outcome was TIMI major or minor bleeding. A propensity score (PS)-matched analysis was done to correct for baseline differences between extended DAPT group and the conventional group.
Results
Among 8,383 subjects, the primary ischemic outcome occurred in 48 patients (0.6%) and the primary bleeding outcome in 49 patients (0.6%). High DS was associated with a higher incidence of ischemic events (ischemic outcome: 0.8% vs. 0.4%, for high vs. low DS, Log-rank p = .039), but not with any differences in bleeding events (Log-rank p = .734). In the PS-matched analysis, extended group was associated with lower risk of composite endpoint of MI, stent thrombosis, or cardiac death in only the high DS group (1.8% vs. 3.7%, Log-rank p = .004; hazard ratio 0.45, 95% confidence interval 0.27-0.76; p = .003 after adjustment).
Conclusions
The DS was an adequate risk stratifier for future ischemic events in East Asians receiving exclusively second generation DES.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 04 Apr 2021; epub ahead of print

Impact of extended dual antiplatelet therapy on long-term prognosis in patients with acute coronary syndrome complicated with anemia: A sub-analysis of the real-world OPT-CAD study.

Zhao Y, Li J, Ma S, Jiang Z, ... Han Y, Li Y
Objectives
To evaluate the impact of extended dual antiplatelet therapy (DAPT) beyond 12 months on long-term prognosis in acute coronary syndrome (ACS) patients complicated with anemia undergoing percutaneous coronary intervention (PCI).
Background
Anemia is frequent among ACS patients and is associated with increased risk of adverse clinical outcomes.
Methods
A total of 6,953 patients were enrolled from the Optimal anti Platelet Therapy for Chinese patients with Coronary Artery Disease (OPT-CAD) study. A landmark analysis comparing extended DAPT versus single antiplatelet therapy (SAPT) at 12-24 months were performed in anemia patients without premature discontinuation of DAPT before 9 months and major clinical adverse events within 12 months. The primary outcome was major adverse cardiovascular and cerebrovascular events (MACCE), defined as a composite of all-cause death, myocardial infarction, and stroke.
Results
Patients with anemia (n = 1,728) had higher rates of MACCE, all-cause mortality, and BARC type 2, 3, 5 bleeding (p < .05) compared to those without anemia (n = 5,225). Anemia patients received extended DAPT (n = 1,010) were associated with a lower risk of stroke (0.3% vs. 1.8%; HR, 0.14; 95% CI, 0.03-0.71; p = .018) compared to those received SAPT (n = 342). The rates of MACCE and all revascularization were lower in patients with extended DAPT, but the differences were not statistically significant. Risk of all-cause mortality and bleeding were comparable between the two groups.
Conclusions
Extended DAPT beyond 12 months may reduce the incidence of stroke without increasing the risk of bleeding in anemic ACS patients who tolerate 12-month DAPT.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 04 Apr 2021; epub ahead of print

Clinical outcomes after permanent polymer or polymer-free stent implantation in patients with diabetes mellitus: The ReCre8 diabetes substudy.

van Hemert ND, Rozemeijer R, Voskuil M, Stein M, ... Stella PR, ReCre8 Study Investigators
Objectives
The purpose of this analysis was to compare target-lesion failure (TLF) of a permanent polymer zotarolimus-eluting stent (PP-ZES) versus a polymer-free amphilimus-eluting stent (PF-AES) in diabetics.
Background
The improvement of outcomes with new-generation drug-eluting stent as seen in the general population is less pronounced among diabetics. The PF-AES introduces an elution-technology with potential enhanced performance in diabetics.
Methods
In this subanalysis of the ReCre8 trial, patients were randomized to either a PP-ZES or PF-AES after stratification for diabetes and troponin status. The primary device-oriented endpoint was TLF, a composite of cardiac death, target-vessel myocardial infarction and target-lesion revascularization.
Results
In the ReCre8 trial, 304 (20%) patients were diabetic and 96 (6%) had insulin-dependent diabetes mellitus. There was no statistically significant difference between the two study arms regarding the primary endpoint (PP-ZES 7.2% vs. PF-AES 4.0%; p = .21), although the composite of net adverse clinical events was higher in the PP-ZES arm (15.7 vs. 8.0%; p = .035). Stent thrombosis was low in both groups with no cases in the PP-ZES arm and 1 case in the PF-AES arm (p = .32). Regarding insulin-treated diabetics, TLF was higher in the PP-ZES arm (14.9 vs. 2.1%; p = .022).
Conclusions
Diabetics could potentially benefit from a dedicated stent, releasing sirolimus with a lipophilic carrier (amphilimus-formulation). Future trials should confirm the potential benefit of a PF-AES in this population.

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

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

Anatomical-functional discordance between quantitative coronary angiography and diastolic pressure ratio during wave-free period.

Nakamura S, Yonetsu T, Hoshino M, Hada M, ... Sasano T, Kakuta T
Objectives
This study sought to determine the predictors of anatomical-functional discordance between quantitative coronary angiography (QCA) derived diameter stenosis (QCA-DS) and diastolic pressure ratio during wave-free period (dPR_WFP ).
Background
The discrepancy between angiographical stenosis and physiological significance is frequently experienced in clinical practice. Although the anatomical-functional discordance between angiography and fractional flow reserve (FFR) has been intensively investigated, that of resting index including dPR_WFP remains to be elucidated.
Methods
In a total of 647 angiographically intermediate lesions with QCA-DS between 30 and 70% in 502 patients, predictors of having QCA-DS >50% and dPR_WFP > 0.89 (QCA-dPR_WFP mismatch), and those of having QCA-DS ≤50% and dPR_WFP ≤ 0.89 (QCA-dPR_WFP reverse mismatch) were determined. FFR ≤0.80 was defined as positive FFR and the predictors of QCA-FFR discordance were determined as well.
Results
QCA-dPR_WFP mismatch and reverse mismatch were observed in 27.5 and 17.6% of cases, respectively. The predictors of mismatch were non-left anterior descending artery (LAD) lesion, large minimal lumen diameter, low baseline heart rate, and high coronary flow reserve (CFR), while those of reverse mismatch were LAD lesion, non-culprit lesion of acute coronary syndrome, long lesion length, low left ventricular ejection fraction, and low CFR and index of microcirculatory resistance. Age, sex, and the culprit vessel of prior myocardial infarction were not significant determinants of QCA-dPR_WFP discordance unlike QCA-FFR discordance derived from the same cohort.
Conclusions
Anatomical-functional discordance between angiography and dPR_WFP was not uncommon. Predictors differed between QCA-dPR_WFP discordance and QCA-FFR discordance.

© 2021 Wiley Periodicals LLC.

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

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: 01 Apr 2021; epub ahead of print

A novel technique for postclosure of large-bore sheaths using two Perclose devices.

Choi CH, Hall JK, Malaver D, Applegate RJ, Zhao DXM
Objectives
This study aimed to assess the feasibility, efficacy, and safety of a novel percutaneous postprocedure closure technique for large arterial sheath removal with the use of two Perclose ProGlide (Abbott Vascular Devices, Redwood City, CA) devices.
Background
Postprocedural closing of large-bore arteriotomies using the Perclose system can be difficult given the subsequent inability of the device to capture sufficient wall tissue.
Methods
Our study was a single-center retrospective analysis of 22 consecutive patients who underwent large arteriotomy closure via the postclosure technique with a 12-16-Fr sheath. Efficacy endpoints included successful deployment of the system and hemostasis. Safety endpoints included the incidence of major or minor vascular complications as defined by the Vascular Academic Research Consortium-2 (VARC-2) definitions at 30-day follow-up.
Results
The postclosure technique resulted in 100% technical success rate and no postprocedural bleeding or vascular complications.
Conclusion
Postclosure technique is a safe, highly effective, and feasible percutaneous method to achieve large-bore arteriotomy hemostasis with low rates of major bleeding or vascular complications and favorable early outcome.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Mar 2021; 97:905-909

Excimer laser coronary atherectomy during complex PCI: An analysis of 1,471 laser cases from the British Cardiovascular Intervention Society database.

Protty MB, Hussain HI, Gallagher S, Al-Raisi S, ... Mamas MA, Kinnaird T
Introduction
Excimer laser coronary atherectomy (ELCA) is a recognized adjunctive therapy utilized in the percutaneous management of complex coronary lesions. Studies examining its safety and utility have been limited by small sample sizes. Our study examines the determinants and outcomes of ELCA.
Methods
Using the British Cardiac Intervention Society database, data were analyzed on all PCI procedures in the UK between 2006-2016. Descriptive statistics and multivariate logistic regressions were used to examine baseline, procedural and outcome associations with ELCA.
Results
We identified 1,471 (0.21%) ELCA cases out of 686,358 PCI procedures. Baseline covariates associated with ELCA use were age, BMI, number of lesions, CTO or restenosis attempted and history of prior MI, CABG or PCI. Procedural co-variates associated with ELCA were the use of glycoprotein inhibitors, intravascular imaging, rotational atherectomy, cutting balloons, microcatheters and intra-aortic balloon pumps. Adjusted rates of in-hospital major adverse cardiac/cerebrovascular events (MACCE) or its individual components (death, peri-procedural MI, stroke and major bleed) were not significantly altered by the use of ELCA. However, there were higher odds of dissection (OR 1.52, 95% CI 1.17-1.98), perforation (OR 2.18, 95% CI 1.44-3.30), slow flow (OR: 1.67, 95% CI 1.18-2.36), reintervention (OR: 2.12, 95% CI 1.14-3.93) and arterial complications (OR: 1.63, 95% CI 1.21-2.21).
Conclusions
ELCA use during complex PCI is associated with higher risk baseline and procedural characteristics. Although increased rates of acute procedural complications were observed, ELCA does not increase likelihood of in-hospital MACCE or its individual components.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Mar 2021; 97:E653-E660

Preprocedural anemia in females undergoing transcatheter aortic valve implantation: Insights from the WIN-TAVI registry.

Nicolas J, Claessen BE, Cao D, Sartori S, ... Chieffo A, Mehran R
Objectives
To assess the impact of anemia on clinical outcomes in female patients enrolled in the Women\'s InterNational transcatheter aortic valve implantation (WIN-TAVI) registry.
Background
Anemia is highly prevalent among females who constitute half of TAVI candidates, yet, its clinical significance remains poorly investigated.
Methods
Patients were divided into three groups according to preprocedural hemoglobin (Hb) level: (1) no anemia (Hb ≥12 g/dl), (2) mild-to-moderate anemia (10 ≤ Hb <12 g/dl), and (3) severe anemia (Hb <10 g/dl). The primary outcome was the occurrence of Valve Academic Research Consortium (VARC)-2 efficacy endpoint, a composite of mortality, stroke, myocardial infarction (MI), hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up.
Results
Hemoglobin level was available in 877 (86.1%) patients: 412 (47.0%) had no anemia, 363 (41.4%) had mild-to-moderate anemia, and 102 (11.6%) had severe anemia. The latter group had a higher prevalence of cardiovascular risk factors. Compared with patients without anemia, severe anemia was associated with a greater risk of VARC-2 efficacy endpoint (_adj HR 1.71, 95% CI: 1.02-2.87, p = .04), all-cause death (_adj HR 2.36, 95% CI: 1.31-4.26, p = .004) and a composite of death, MI or stroke (_adj HR 1.88, 95% CI: 1.10-3.22, p = .02) at 1 year. Moreover, an increased risk of late mortality (_adj HR 1.15, 95% CI: 1.02-1.30, p = .03) was observed with every 1 g/dl decrease in hemoglobin level.
Conclusion
Severe anemia in females undergoing TAVI was independently associated with increased rates of VARC-2 efficacy endpoint and mortality at 1 year.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Mar 2021; 97:E704-E715

A dedicated Y-shaped percutaneous ECMO cannula for femoral 2-in-1 vascular access during high-risk procedures.

Modine T, Vincent F, Delhaye C, Van Belle E
High-risk transcatheter procedures requiring hemodynamic support are growing and require multiple vascular access that may be challenging in cases of peripheral artery disease or lack of radial access and exposure to a higher risk of vascular complications. We report the novel utilization of a Y-shaped arterial extracorporeal membrane oxygenation (ECMO) cannula used as a single femoral access to perform percutaneous coronary intervention (PCI) and aortography during high-risk transcatheter aortic valve replacement (TAVR). The utilization of this 2-in-1 ECMO cannula may simplify vascular access and reduce vascular and bleeding complications during high-risk ECMO-supported transcatheter procedures.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Mar 2021; 97:959-961

Effect of a fourth-generation transcatheter valve enhanced skirt on paravalvular leak.

Welle GA, El-Sabawi B, Thaden JJ, Greason KL, ... Rihal CS, Eleid MF
Objectives
The aim of this study was to assess the 30 day incidence of paravalvular leak (PVL) and need for aortic valve reintervention of a fourth generation balloon expandable transcatheter valve with enhanced skirt (4G-BEV) (SAPIEN 3 Ultra) compared with a third generation balloon expandable transcatheter valve (3G-BEV) (SAPIEN 3).
Background
The incidence of PVL has steadily declined with iterative improvements in transcatheter aortic valve replacement (TAVR) technology and implantation strategies.
Methods
Patients who underwent TAVR at Mayo Clinic from 7/2018 to 7/2019 were included in a prospective institutional registry. 4G-BEV has been utilized since 2/2019, and, after this date, 3G-BEV and 4G-BEV were simultaneously used. 4G-BEV had three sizes (20, 23, and 26 mm) while 3G-BEV included four sizes (20, 23, 26, and 29 mm). Both cohorts were evaluated at 30 days post-TAVR with a transthoracic echocardiogram to assess for PVL.
Results
A total of 260 consecutive patients were included. Of these, 101 patients received a 4G-BEV and 159 patients received a 3G-BEV. There were more females (p = .0005) and a lower aortic valve calcium score (p = .02) in the 4G-BEV cohort at baseline. Age, STS risk score, NYHA Class, and aortic valve mean gradient did not differ between groups. 4G-BEV was associated with a lower incidence of mild PVL (10.8 vs. 36.5%; p < .0001) and moderate PVL (0 vs. 5.8%) compared to the 3G-BEV at 30 days. There was no association between PVL and valve size in either cohort.
Conclusions
Utilization of 4G-BEV is associated with reduced PVL at 30 days post-TAVR compared with 3G-BEV.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Mar 2021; 97:895-902

A novel technique to manage transcatheter aortic valve embolization.

Chawla KK, Huang X, Hadro N, Islam AM
We report a case of a 69-year-old male who was planned for a transcatheter aortic valve replacement (TAVR) with a 26 mm Sapien 3 Valve (Edwards Lifesciences, Irvine, California) for the treatment of symptomatic severe aortic stenosis. During rapid ventricular pacing and implantation of the TAVR valve, there was a loss of pacing capture and subsequent embolization of the valve into the aortic arch. Retrieval of the embolized valve was attempted unsuccessfully using several techniques. Finally, by using a 34 mm Evolut R Valve (Medtronic, Minneapolis, Minnesota), we were able to secure the embolized valve in the transverse segment of the aortic arch without compromising the branch vessels. To our knowledge, this is the first reported case of using a valve-in-valve approach to fixate an embolized valve in the transverse aorta.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Mar 2021; 97:955-958

Sex-stratified analysis of the safety of percutaneous left atrial appendage occlusion.

Osman M, Patel B, Munir MB, Kawsara A, ... Michos ED, Alkhouli M
Objectives and background
There is insufficient current evidence about whether sex impacts outcomes of percutaneous left atrial appendage occlusion (LAAO). The aim of this study was to investigate the association between sex and short-term outcomes of LAAO.
Methods
Patients who were hospitalized and underwent LAAO from October 2015 to December 2017 in the National Readmission Database were queried. The primary endpoint of interest was major in-hospital adverse events. Secondary endpoints included, 30-day readmission rate, nonhome discharge, and cost of hospitalization. Propensity score matching (1:1) was performed to compare the outcomes among women and men.
Results
A total of 9,281 patients were included in the current analysis [women = 3,659 (39%); men = 5,622 (61%)]. Comparing women to men, women had lower prevalence of diabetes mellitus (30.6% vs 35.7%, p < .01), heart failure (28.6% vs 30.8%, p = .03), vascular disease (55.5% vs 69.6%, p < .01) and renal failure (18.3% vs 21.2%, p < .01), and higher CHA₂ DS₂ VASc score (5 [IQR4-6] vs 4 [IQR3-6], p < .01). After propensity-score matching, women had higher rate of major in-hospital adverse events (2.8% vs 1.9%; p < .01), and nonhome discharges (11.4% vs 6.7%; p < .01). Additionally, 30-day readmission rate was higher among women (10% vs 8.6%, p = .03).
Conclusion
Among hospitalized patients undergoing LAAO, women carry higher risk for major in-hospital adverse events, nonhome discharge, and 30-day readmission rates.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Mar 2021; 97:885-892

Gender-based outcomes of impeller pumps percutaneous ventricular assist devices.

Osman M, Syed M, Abdul Ghaffar Y, Patel B, ... Balla S, Daggubati R
Background
There is paucity of data focusing on females\' outcomes after the use of impeller pumps percutaneous ventricular assist devices (IPVADs).
Methods
Patients who received IPVADs during the period of October 1st, 2015-December 31, 2017, were identified from the United States National Readmission Database. A 1:1 propensity score matching was used to compare the outcomes between females and males.
Results
A total of 19,278 (Female = 5,456; Male = 13,822) patients were included in the current analysis. After propensity score matching and among all-comers who were treated with IPVADs, females had higher in-hospital major adverse events (MAEs) (38 vs. 32.6%, p < .01), mortality (31 vs. 28%, p < .01), vascular complications (3.3 vs. 2.1%, p < .01), major bleeding (7.8 vs. 4.8%, p < .01), nonhome discharges (21.6 vs. 16.3%; p < .01), and longer length of stay (7 days [IQR 2-12] vs. 6 days [IQR 2-12], p = .02) with higher 30-day readmission rate compared to males (20.5 vs.16.4%, p < .01). Furthermore, among patients who received the IPVADs for high-risk percutaneous coronary intervention (HRPCI), females continued to have worse MAEs, which was driven by high rates of major bleeding. However, among patients who received IPVADs for cardiogenic shock (CS) the outcomes of females and males were comparable.
Conclusions
Among all-comers who received IPVADs, females suffered higher morbidity and mortality compared to males. Higher morbidity driven mainly by higher rates of major bleeding was seen among females who received IPVADs for the hemodynamic support during HRPCI and comparable outcomes were observed when the IPVADs were used for CS.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Mar 2021; 97:E627-E635

Expanding the stroke team to include interventional cardiology.

Mendelsohn FO, Holmes DR, Hopkins LN
Team-based care has been emphasized as a strategy to improve and optimize outcomes for broad groups of patients who have presented with often complex medical conditions including large vessel cerebral occlusion. Although neurointerventionalists from different specialties perform mechanical embolectomy, which has become the standard of care for large vessel cerebral occlusion, these specialties are limited by relatively low numbers typically concentrated in a small number of sites. In this single center experience, approximately 50 patients with large vessel stroke were transferred out of an emergency room to other centers despite the availability of an experienced cardiologist with extensive carotid experience. Such transfer strategies typically result in delays in receiving reperfusion and, therefore, may decrease the success rates and substantial improvement that can be obtained by patients in this setting. Trained interventional cardiologists in centers with limited 24/7/365 coverage could achieve rapid revascularization and reperfusion saving lives. In order to accommodate the need for treating these patients, carotid stent trained cardiologists should enter the arena, learn mechanical embolectomy, and be supported by their colleagues from other disciplines on acute stroke care teams.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Mar 2021; 97:874-875

Effectiveness and safety of same day discharge after left atrial appendage closure under moderate conscious sedation.

Marmagkiolis K, Ates I, Kose G, Iliescu C, Cilingiroglu M
Background
Left atrial appendage occlusion (LAAO) using Watchman device has become a world-wide, well-established therapeutic alternative to chronic systemic oral anticoagulation in patient who are at high-risk of bleeding with paroxysmal (PAF) or chronic atrial fibrillation (Afib). Currently, LAAO procedures are performed under general anesthesia (GA) and patients stay overnight post procedure in the United States. We aimed to present the effectiveness and safety of same day discharge following LAAO under moderate conscious sedation (MCS) in patients without procedural complications.
Methods
A total of 112 patients between August 2019 and May 2020 with elevated CHA₂ DS₂ VASc (median score of 3) underwent transesophageal echocardiography (TEE)-guided LAAO with FDA approved Watchman (Boston Scientific, MN) under MCS and discharged home on the same day 6 hr following their post procedural transthoracic echocardiogram (TTE) evaluations. All patients had next day TTE and follow up at the cardiology clinic. We prospectively evaluated clinical and procedural outcomes using medical records of these patients.
Results
Among all the patients, the mean age was 83.5 ± 8.5 years, 45 (40%) were women. Procedural duration, device implant time and fluoroscopic times were 45 ± 8.6, 14.5 ± 7.8 and 10.2 ± 1.2 min, respectively. The median required dosage of propofol was 105 ± 2.8 mg. No complications arose from MCS. There was no need for conversion to GA in any of the patients during the procedure. All patients were able to be discharged 6 hr following their TTE evaluation post procedure. There were no procedural complications.
Conclusions
Same day discharge following LAAO closure seems to be safe and effective in patients without procedural complications. LAAO can also be performed safely and effectively under moderate conscious sedation. Applying moderate conscious sedation may simplify the LAAO procedure, reduce procedural time, procedural costs and hospital stay while increasing overall patient satisfaction.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Mar 2021; 97:912-916

Catheter directed embolectomy of right atrial clot in transit-A case series.

Verma I, Chang EY, Kumar G, Sachdeva R
In the previous literature, the prevalence of right atrial (RA) clot-in-transit associated with pulmonary embolism is around 4-18% with an associated mortality of 80-100% in untreated cases. Surgical thrombo-embolectomy has been the mainstay of treatment for stable patients but the data for percutaneous thrombo-embolectomy is lacking in the literature. We present a series of three cases of right atrium clot-in-transit treated with catheter-based therapies with Inari FlowTriever® (Inari Medical, Irvine, CA). Our three patients had different clinical profiles and presentations of right atrial clot-in-transit. All of the subjects had contraindications to surgical thrombo-embolectomy and thrombolytic therapy. Catheter based embolectomy using Inari FlowTriever® was successfully performed in all the patients. As the data on this intervention is sparse, our case series highlights successful catheter based thrombo-embolectomies in high-risk individuals with right atrial clot in-transit with or without pulmonary embolism.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Mar 2021; 97:869-873

Impact of preexisting coronary arterial disease in patients undergoing percutaneous mitral valve repair (MitraClip).

Gifft K, Omran J, Ghrair F, Allaham H, ... Abdullah O, Enezate T
Introduction
Percutaneous mitral valve repair with Mitraclip device has been approved for the treatment of symptomatic mitral valve regurgitation in patients deemed high surgical risk. It\'s unclear whether the presence of preexisting coronary arterial disease (CAD) affects the postprocedural outcomes of Mitraclip.
Methods
The study population was extracted from the 2016 Nationwide Readmissions Data (NRD) using the International Classification of Diseases, Tenth Revision, Clinical Modifications/Procedure Coding System (ICD-10-CM/PCS) for Mitraclip, preexisting CAD, and postprocedural complications. Study primary endpoints included in-hospital all-cause mortality, cardiogenic shock, acute myocardial infarction (AMI), acute kidney injury (AKI), stroke, acute respiratory failure, length of hospital stay (LOS), and 30-day readmission rate.
Results
A total of 2,539 discharges that had Mitraclip during the index hospitalization, 62.3% had history of preexisting CAD. Mean age was 78.5 years and 46.6% were female. Overall, the presence of preexisting CAD was associated with higher AMI (1.6 vs. 0.4%, p < .01), however, there was no significant differences in terms of in-hospital all-cause mortality (2.2 vs. 2.6%, p = .52), cardiogenic shock (3.4 vs. 4.1%, p = .39), AKI (14.7 vs. 13.6%, p = .43), stroke (0.9 vs. 0.5%, p = .31), acute respiratory failure (9.7 vs. 8.8%, p = .43), LOS (5.3 vs. 5.3 days, p = .85) or 30-day readmission rate (14.6 vs. 14.4%, p = .92). These results persisted after adjustment for baseline characteristics. The subgroup of CAD patients who received percutaneous coronary intervention (PCI) was associated with higher in-hospital mortality (22.5 vs. 2.0%, p < .01), cardiogenic shock (25.0 vs. 3.3%, p < .01), AMI (22.5 vs. 0.8%, p < .01), AKI (55.0 vs. 13.7%, p < .01), stroke (10.0 vs. 0.6%, p < .01), acute respiratory failure (45.0 vs. 8.8%, p < .01), and longer LOS (21.5 vs. 5.1 days, p < .01), however there was no significant difference in 30-day readmission rate (15.0 vs. 14.5%, p = .95).
Conclusions
Preexisting CAD was associated with higher in-hospital AMI post-Mitraclip but with comparable mortality and other morbidities. Patients who received PCI during the same index hospitalization had higher in-hospital mortality and morbidity.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Mar 2021; 97:919-924

Efficacy of the novel technique HIRANODOME in preventing distal embolization during endovascular treatment of femoropopliteal lesions.

Fukagawa T, Hirano K, Mori S, Yamawaki M, ... Makino K, Ito Y
Objectives
The efficacy and clinical outcomes of a novel technique \"HIRANODOME\" (Interim hemostatic technique with HIgh pressure for Regional blood flow in the superficial femoral Artery, NOninvasive Distal protection Occlusion MEthod) in preventing distal embolization during endovascular treatment (EVT) of femoropopliteal lesions were evaluated.
Background
Distal embolization of femoropopliteal lesions may worsen limb ischemia or cause limb loss. Conventional filter wires are cumbersome and expensive and may cause vessel injury. HIRANODOME can, therefore, be a feasible and noninvasive alternative.
Methods
Between April 2007 and August 2018, 94 consecutive patients who underwent EVT for femoropopliteal lesions along with anticipated distal embolization were identified. About 9 out of these 94 patients were excluded due to filter device use and 8 were excluded due to acute limb ischemia. Consequently, 77 patients using HIRANODOME for distal protection were included. HIRANODOME involved wrapping the Tometakun around the knee to enable external compression of the popliteal artery, thereby blocking the blood flow. The evaluation items were 30-day mortality, 30-day major amputation, prevention from distal embolization, and thrombus capture rate.
Results
The mean age was 74.4 ± 10.3 years, 53.2% were men, 55.8% were diabetic, and 9.1% were on hemodialysis. The mean lesion length was 199.5 ± 94.4 mm; 79.2% were class C/D lesions (TASC II classification). The 30-day mortality and major amputation rates were 1.9 and 1.0%, respectively. The rate of prevention of distal embolization or no-flow/slow-flow phenomenon was 93.4%. Capture of thrombus was observed in 66 lesions (62.3%).
Conclusions
The HIRANODOME technique was effective in preventing distal embolization during EVT of femoropopliteal lesions.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Mar 2021; 97:E697-E703

Feasibility of transcatheter closure for absent aortic rim in patients with atrial septal defect.

Takaya Y, Akagi T, Nakagawa K, Nakayama R, ... Toh N, Ito H
Objectives
This study aimed to assess the feasibility of transcatheter atrial septal defect (ASD) closure in patients with absent aortic rim.
Background
The indication of transcatheter closure for ASD with absent aortic rim is controversial.
Methods
We enrolled 547 patients with ASD who were scheduled for transcatheter closure. Morphologies of aortic rim were evaluated using transesophageal echocardiography (TEE).
Results
Aortic rim of <5 mm was observed in 396 (72%) patients; 128 (23%) had absent aortic rim of 0 mm, and 268 (49%) had deficient aortic rim of >0 to <5 mm. Patients with absent aortic rim frequently had aortic rim absence at an angle of 0° on TEE and septal malalignment. Of the 128 patients with absent aortic rim, 126 (98%) successfully underwent transcatheter closure, while 2 (2%) failed transcatheter closure due to a large defect with severe septal malalignment. The success rate of transcatheter closure was similar between patients with absent aortic rim and those with deficient aortic rim (98% vs. 99%, p = .45). After the procedure, no patients had erosion or device embolization during a median follow-up of 24 months.
Conclusions
Transcatheter closure was successfully performed without adverse events in patients with absent aortic rim, as well as in those with deficient aortic rim. Our findings can be valuable to determine the indication of transcatheter closure in patients with ASD.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Mar 2021; 97:859-864

Expanding percutaneous treatment of mitral valve diseases: Transcatheter closure of mitral valve leaflet perforation.

Carretero Bellón JM, Morr IC, Merchan EF, Prada FH
Mitral valve perforation is a rare cause of mitral regurgitation. We present a case of a 16-year-old patient with mitral valve regurgitation after redo-cardiac surgery for recurrent subaortic stenosis. Transthoracic echocardiography revealed a mitral regurgitation with an eccentric jet causing a significant regurgitation documented by the presence of a convergence flow over the hole. This finding was corroborating by transesophageal echocardiography locating the perforation from the region of A2 scallop. Three-dimensional transesophageal echocardiography confirmed these findings and played a key role guiding the procedure. Typical approach is usually a cardiac surgical procedure based on repair the perforation, but the mitral orifice was successfully closed percutaneously using an Amplatzer Duct Occluder II (ADO II; Abbott Vascular, IL).

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Mar 2021; 97:E692-E696

Modified wire atrial septostomy with a reverse transseptal puncture in an infant: Case report.

Nagatomo Y, Nagata H, Yamamura K, Ohga S
We report a modified technique of wire atrial septostomy (WAS) with a reverse transseptal puncture (TSP) in an infant case of pulmonary atresia with intact ventricular septum. A radiofrequency (RF) wire was advanced to the septum through a 4 Fr pigtail catheter hooked on the left side of atrial septum and RF energy was applied while advancing the wire across the septum. Following that reverse TSP, WAS was performed to cut the septal tissue using a 0.010 microwire and RF wire. The atrial septum defect (ASD) was enlarged to a size of 15 mm. WAS with a reverse TSP could be a useful and safe method to enlarge ASD in infants with congenital heart diseases.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Mar 2021; 97:865-868

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: 31 Mar 2021; epub ahead of print

Timing of Impella implantation and outcomes in cardiogenic shock or high-risk percutaneous coronary revascularization.

Tarantini G, Masiero G, Burzotta F, Pazzanese V, ... Chieffo A, IMPella Mechanical Circulatory Support Device in Italy (IMP-IT) Registry authors
Objective
To evaluate the role of the microaxial percutaneous mechanical circulatory support device (Impella® pump) implantation pre-percutaneous coronary intervention (PCI) versus during/after PCI in cardiogenic shock (CS) and high-risk PCI populations.
Background
A better understanding of the safety and effectiveness of the Impella and the role of timing of this support initiation in specific clinical settings is of utmost clinical relevance.
Methods
A total of 365 patients treated with Impella 2.5/CP in the 17 centers of the IMP-IT Registry were included. Through propensity-score weighting (PSW) analysis, 1-year clinical outcomes were assessed separately in CS and HR-PCI patients, stratified by timing of Impella support.
Results
Pre-procedural insertion was associated with an improvement in 1-year survival in patients with CS due to acute myocardial infarction (AMI) treated with PCI (p = .04 before PSW, p = .009 after PSW) and HR-PCI (p < .01 both before and after PSW). Among patients undergoing HR-PCI, early Impella support was also associated with a lower rate of the composite of mortality, re-hospitalization for heart failure, and need for left-ventricular assist device/heart transplantation at 1-year (p = .04 before PSW, p = .01 after PSW). Furthermore, Impella use during/after PCI was associated with an increased in-hospital life-threatening and severe bleeding among patients with AMI-CS receiving PCI (7 vs. 16%, p = .1) and HR-PCI (1 vs. 9%, p = .02).
Conclusions
Our findings suggested a survival benefit and reduced rates of major bleeding when a pre-PCI Impella implantation instead of during-after procedure was used in the setting of HR-PCI and AMI-CS.

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

Catheter Cardiovasc Interv: 31 Mar 2021; epub ahead of print

A new over-the-wire percutaneous mitral balloon valvuloplasty technique.

Weich H, van Veyeren LM
Objectives
To develop and evaluate a new over-the-wire technique for mitral valvuloplasty that is both technically easier and less costly.
Background
Rheumatic heart disease (RHD) and resultant mitral stenosis (MS) carries a significant burden of disease worldwide. The prevalence is however concentrated in lower income countries where the current gold standard for percutaneous mitral valvuloplasty (PMBV)-the Inoue technique, is not always available due to cost and technical complexity.
Methods
The development of an over-the-wire technique involving a steerable catheter to aid crossing of the valve and a dedicated TAVI wire is described. The procedure evolved over the initial eight cases and the final standardized procedure was performed in 16 cases. Clinical, echocardiographic and procedural outcomes are described in 16 consecutive cases performed at a single center.
Results
The procedure was performed with 88% procedural success and only one technical failure during the development phase. 2/24 patients had moderate mitral regurgitation (MR) afterwards but one had unfavorable anatomy and the other had pre-procedural moderate MR. The average procedural duration was 66 min, which was shortened significantly over time. No procedural deaths or conversion to open surgery at 1 year. Procedural cost was 44% lower than the Inoue technique.
Conclusion
We present favorable results of a new PMBV technique that is cheaper and technically easier in our opinion.

© 2021 Wiley Periodicals LLC.

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

Comparison of the investigational device exemption and post-approval trials of the Melody transcatheter pulmonary valve.

Kreutzer J, Armstrong AK, Rome JJ, Zellers TM, ... Bergersen LJ, McElhinney DB
Objective
We compared 5-year outcomes of transcatheter pulmonary valve (TPV) replacement with the Melody TPV in the post-approval study (PAS) and the investigational device exemption (IDE) trial.
Background
As a condition of approval of the Melody TPV after the IDE trial, the Food and Drug Administration required that a PAS be conducted to evaluate outcomes of TPV replacement in a \"real-world\" environment. The 5-year outcomes of the PAS have not been published, and the IDE and PAS trials have not been compared.
Methods
The cohorts comprised all patients catheterized and implanted at 5 IDE sites and 10 PAS sites. Differences in trial protocols were detailed. Time-related outcomes and valve-related adverse events were compared between the two trials with Kaplan-Meier curves and log-rank testing.
Results
167 patients (median age, 19 years) were catheterized and 150 underwent TPV replacement in the IDE trial; 121 were catheterized (median age, 17 years) and 100 implanted in the PAS. Freedom from hemodynamic dysfunction (p = .61) or any reintervention (p = .74) over time did not differ between trials. Freedom from stent fracture (p = .003) and transcatheter reintervention (p = .010) were longer in PAS, whereas freedom from explant (p = .020) and TPV endocarditis (p = .007) were shorter. Clinically important adverse events (AEs) were reported in 14% of PAS and 7.2% of IDE patients (p = .056); the incidence of any particular event was low in both.
Conclusions
Hemodynamic and time-related outcomes in the PAS and IDE trials were generally similar, confirming the effectiveness of the Melody TPV with real-world providers. There were few significant complications and limited power to identify important differences in AEs. The lack of major differences in outcomes between the two studies questions the usefulness of mandated costly post-approval studies as part of the regulatory process for Class III medical devices.

© 2021 Wiley Periodicals LLC.

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

Association of the age shock index with coronary plaque characteristics in ST-segment elevation myocardial infarction: A 3-vessel optical coherence tomography study.

Zhao L, Du Z, Wu T, Cao M, ... Jia H, Yu B
Objectives
We investigated whether the age shock index (SI) was associated with coronary plaque characteristics in patients with ST-segment elevation myocardial infarction (STEMI) using optical coherence tomography (OCT).
Background
The age SI is a simple clinical parameter that effectively predicts poor clinical outcomes among patients with STEMI.
Methods
This retrospective study evaluated 408 STEMI patients who underwent 3-vessel OCT during emergency percutaneous coronary interventions at a single center between January 2017 and October 2018. Patients were divided into groups with low or high age SI values (<41 vs. ≥41). Plaque characteristics were compared between the two groups for both culprit lesions (n = 408) and non-culprit lesions (n = 1,077).
Results
In culprit lesions, patients with a high age SI (≥41) were more likely to have plaque rupture (61.0% vs. 56.8%, p = .002) and thinner fibrous caps (fibrous cap thickness [FCT]: 40.0 [33.0-53.0] μm vs. 46.0 [36.0-63.8] μm, p = .021). In non-culprit lesions, patients with a high age SI were more likely to have high-risk plaques (29.9% vs. 17.8%, p = .018; simultaneous presence of a minimal lumen area of <3.5 mm² , maximum lipid arc of >180°, FCT of <75 μm, and macrophage accumulation). Plaque-based analyses revealed that patients with a high age SI had larger lipid cores and lesser FCT.
Conclusions
Patients with STEMI and a high age SI had increased risks of culprit plaque rupture and high-risk non-culprit plaques, and vulnerable plaque features at the culprit and non-culprit lesions. Therefore, a high age SI in patients with STEMI may indicate greater pancoronary vulnerability.

© 2021 Wiley Periodicals LLC.

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

Zero contrast optical coherence tomography-guided percutaneous coronary intervention in patients with non-ST segment elevation myocardial infarction and chronic kidney disease.

Liu ZY, Yin ZH, Liang CY, He J, ... Zheng ZF, Pan HW
Objectives
To investigate a strategy for ultra-low volume contrast percutaneous coronary intervention (PCI) with the aims of preserving renal function and observing the 90-day clinical endpoint in patients with non-ST-elevated myocardial infarction (non-STEMI) and chronic kidney disease (CKD).
Background
The feasibility, safety, and clinical utility of PCI with ultra-low radio-contrast medium in patients with non-STEMI and CKD are unknown.
Methods
A total of 29 patients with non-STEMI and CKD (estimated glomerular filtration rate [eGFR] of ≤60 ml/min/1.73 m² ) were included. Ultra-low volume contrast PCI was performed after minimal contrast coronary angiography using zero contrast optical coherence tomography (OCT) guidance. Pre- and post-PCI angiographic measurements were performed using quantitative flow ratio (QFR) for pre-perfusion assessment and verifying improvement.
Results
The median creatinine level was 2.1 (inter-quartile range 1.8-3.3), and mean eGFR was 48 ± 8 ml/min/1.73 m² pre-PCI. During the PCI procedure, OCT revealed 15 (52%) cases of abnormalities post-dilation. There was no significant change in the creatinine level and eGFR in the short- or long-term, and no major adverse events were observed.
Conclusion
In non-STEMI patients with high-risk CKD who require revascularization, QFR and no contrast OCT-guided ultra-low contrast PCI may be performed safely without major adverse events.

© 2021 Wiley Periodicals LLC.

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

Revascularisation strategies in patients with significant left main coronary disease during the COVID-19 pandemic.

Mohamed MO, Curzen N, de Belder M, Goodwin AT, ... Kinnaird T, Mamas MA
Background
There are limited data on the impact of the COVID-19 pandemic on left main (LM) coronary revascularisation activity, choice of revascularisation strategy, and post-procedural outcomes.
Methods
All patients with LM disease (≥50% stenosis) undergoing coronary revascularisation in England between January 1, 2017 and August 19, 2020 were included (n = 22,235), stratified by time-period (pre-COVID: 01/01/2017-29/2/2020; COVID: 1/3/2020-19/8/2020) and revascularisation strategy (percutaneous coronary intervention (PCI) vs. coronary artery bypass grafting (CABG). Logistic regression models were performed to examine odds ratio (OR) of 1) receipt of CABG (vs. PCI) and 2) in-hospital and 30-day postprocedural mortality, in the COVID-19 period (vs. pre-COVID).
Results
There was a decline of 1,354 LM revascularisation procedures between March 1, 2020 and July 31, 2020 compared with previous years\' (2017-2019) averages (-48.8%). An increased utilization of PCI over CABG was observed in the COVID period (receipt of CABG vs. PCI: OR 0.46 [0.39, 0.53] compared with 2017), consistent across all age groups. No difference in adjusted in-hospital or 30-day mortality was observed between pre-COVID and COVID periods for both PCI (odds ratio (OR): 0.72 [0.51. 1.02] and 0.83 [0.62, 1.11], respectively) and CABG (OR 0.98 [0.45, 2.14] and 1.51 [0.77, 2.98], respectively) groups.
Conclusion
LM revascularisation activity has significantly declined during the COVID period, with a shift towards PCI as the preferred strategy. Postprocedural mortality within each revascularisation group was similar in the pre-COVID and COVID periods, reflecting maintenance in quality of outcomes during the pandemic. Future measures are required to safely restore LM revascularisation activity to pre-COVID levels.

© 2021 Wiley Periodicals LLC.

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

Angiographic characteristics and long-term outcomes of single-vessel chronic total occlusion percutaneous coronary intervention in patients with and without previous myocardial infarction.

Hu X, Qiao S, Guan C, Guo C, ... Song L, Xu B
Objective
This study evaluated the angiographic characteristics and clinical outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) among patients with and without a history of myocardial infarction (MI).
Background
The pathogenesis of CTO and myocardial viability are different in cases with or without previous MI. However, the lesion characteristics and clinical outcomes are unclear for these two groups.
Methods
We reviewed consecutive patients who underwent single-vessel CTO PCI from 2010 to 2013. Patients were classified according to their history of MI. Acute procedural results were classified as optimal recanalization, suboptimal recanalization, or technical failure. The primary endpoint was the 5 year rate of cardiac death.
Results
We identified 2,191 eligible patients, including 859 patients (39.2%) with previous MI. The overall technical success rate was 74.4%. Relative to the non-MI group, the MI group had a larger reference vessel diameter (3.0 ± 0.5 vs. 2.9 ± 0.4 mm, p = .002), a lower proportion of Werner grade ≥ 1 collateral circulation (65.4 vs. 79.2%, p < .001), a higher proportion of optimal recanalization (63.1 vs. 58.6%, p = .006), and a higher 5-year rate of cardiac death (3.9 vs. 2.1%, p = .02). In the MI group, suboptimal recanalization was associated with a significantly higher 5-year rate of spontaneous MI, relative to optimal recanalization and technical failure (11.7 vs. 4.6 vs. 4.1%, p = .006).
Conclusions
Patients with CTO and previous MI had a larger reference vessel diameter, lower level of collateral circulation, and higher proportion of optimal recanalization. However, suboptimal recanalization in these patients was associated with an increased risk of spontaneous MI.

© 2021 Wiley Periodicals LLC.

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

Trends in the utilization and reimbursement of coronary revascularization in the United States Medicare population from 2010 to 2018.

Shah AM, Siddiqui E, Cuenca C, Drotar P, ... Waxman S, Sambol J
Objective
To determine utilization and reimbursement trends of coronary revascularization procedures in the US Medicare population from 2000 to 2018.
Background
US Medicare population is increasing, and coronary revascularization decreased in the 2000s.
Methods
This is a population-based, cross sectional study of US Medicare beneficiaries from 2010 to 2018. The Centers for Medicare and Medicaid Services\' database was queried for revascularization procedures using the coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) current procedural terminology (CPT) codes. Trends in Medicare enrollees, PCIs, CABGs, and physician reimbursements were analyzed.
Results
Total utilization and reimbursement decreased for both revascularization procedures. The national CABG and PCI utilization per enrollee has decreased by 40.7% (best fit line: b coefficient, 95% CI; -0.297, -0.358 to -0.235) and 26.4% (best fit line: -0.229, -0.373 to -0.0858), respectively. For PCI, annual Medicare payout per enrollee and physician compensation per procedure has decreased by 49.3% (best fit line: -0.250, -0.315 to -0.185) and 14.5% (best fit line: -11.54, -15.62 to -7.452), respectively, and for CABG, decreased by 53.3% (best fit line: -0.373, -0.560 to -0.186) and 36.6% (best fit line: -34.15, -49.35 to -18.95), respectively. Amongst the states, there was significant variability in procedure utilization, and CABG reimbursement rates but minimal variability in PCI reimbursement rates.
Conclusion
Even though the US population has aged, revascularization utilization and reimbursement continue to decline. Advancement in medical intervention strategies, particularly non-surgical management, may account for these trends. Further understanding of these trends will allow health systems to tailor resources to the aging population.

© 2021 Wiley Periodicals LLC.

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

Fusion imaging guided implantation of a Tricento transcatheter heart valve for severe tricuspid regurgitation.

Boeder NF, Bayer M, Dörr O, Nef HM
We report the case of a 64-year-old patient with history of chronic kidney disease on dialysis who was repeatedly hospitalized due to hydropic decompensation. Right heart failure with secondary severe tricuspid regurgitation was diagnosed. An interventional approach was recommended due to the heavy calcification of the sinus venosus and the perioperative risk (EuroScore II 3.2%) and taking into account the explicit request of the patient. After analysis of a full-cycle computed tomography, the patient was eligible for the implantation of the Tricento transcatheter heart valve. The custom-made prosthesis was implanted successfully using periprocedural transoesophageal guidance supported by fusion imaging that integrates live co-registration. After implantation of the valve prosthesis, the primary result was excellent. The patient was discharged without further complications shortly after the procedure and her status is being closely monitored.

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

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

Early radial artery occlusion following the use of a transradial 7-French sheath for complex coronary interventions in Chinese patients.

Wang H, Wang HY, Yin D, Feng L, ... Zhu CG, Dou KF
Objectives
We aimed to explore the impact of 7-Fr sheaths on the incidence of early radial artery occlusion (RAO) after transradial coronary intervention (TRI) in Chinese patients.
Background
RAO precludes future use of the vessel for vascular access. Transradial catheterization is usually performed via 5-Fr or 6-Fr catheters; 7-Fr sheath insertion enables complex coronary interventions but may increase the RAO risk.
Methods
We prospectively enrolled 130 consecutive patients undergoing complex TRI using 7-Fr sheaths. Radial artery ultrasound assessment was performed before and after TRI. Early RAO was defined as the absence of flow on ultrasound within 6-24 hr after TRI. Multivariate logistic regression was used to determine the factors related to early RAO after TRI.
Results
7-Fr sheaths were mainly used for chronic total occlusion (44.6%), bifurcation (30.0%), and tortuous calcification (25.4%) lesions. All patients were successfully sheathed. Percutaneous coronary intervention (PCI) procedural success was 96.2%; 119 patients (91.5%) had preserved radial artery patency after TRI. All 11 RAO cases (8.5%) were asymptomatic. The radial artery diameter was significantly larger postoperatively (3.1 ± 0.4 mm) than preoperatively (2.6 ± 0.5 mm) (p < .001). No parameters significantly differed between patients with and without RAO. TRI history was the only independent risk factor of early RAO (odds ratio: 6.047, 95% confidence interval: 1.100-33.253, p = .039).
Conclusions
7-Fr sheath use after transradial access for complex PCI is feasible and safe. Evaluating the radial artery within 24 hr after TRI allows timely RAO recognition, important for taking measures to maintain radial artery patency and preserve access for future TRIs.

© 2021 Wiley Periodicals LLC.

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

Single antiplatelet therapy with use of prasugrel in patients undergoing percutaneous coronary intervention.

Otsuka T, Ueki Y, Kavaliauskaite R, Zanchin T, ... Windecker S, Räber L
Objectives
We aimed to assess the ischemic and bleeding risks of single antiplatelet therapy (SAPT) with prasugrel compared with standard dual antiplatelet therapy (DAPT) (aspirin plus clopidogrel for 1 year) in patients with chronic coronary syndrome (CCS) treated with new generation drug-eluting stents (DES).
Background
To date, data on SAPT with potent P2Y12 inhibitors in the absence of aspirin immediately after PCI are limited.
Methods
Between January 2009 and November 2019, all CCS patients undergoing percutaneous coronary intervention (PCI) enrolled to the Bern PCI registry were considered for analysis. We performed propensity score matching in a 1:4 fashion to compare patients who received SAPT with prasugrel versus standard DAPT. The primary ischemic endpoint was a composite of cardiovascular death, myocardial infarction, and stroke and the primary bleeding endpoint was BARC 3 or 5 bleeding, both assessed at 1 year.
Results
After propensity score matching, the final study population consisted of 225 patients with SAPT and 889 with DAPT. There was no significant difference in rates of the primary ischemic (5.2% vs. 4.2%, p = .50) or the primary bleeding (1.5% vs. 2.0%, p = .60) endpoints between groups. SAPT was not associated with an increased risk of definite stent thrombosis (0.9% vs. 0.8%, p = .83).
Conclusions
Among selected CCS patients undergoing PCI with DES, SAPT with prasugrel was not associated with an excess of ischemic events compared with standard DAPT. No difference in bleeding was observed either. The results may serve as the basis for larger trials assessing the potential benefits and risks of SAPT.

© 2021 Wiley Periodicals LLC.

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

Prognostic value of quantitative flow ratio measured immediately after drug-coated balloon angioplasty for in-stent restenosis.

Cai X, Tian F, Jing J, Jin Q, ... Fu Z, Chen Y
Objectives
This study aimed to evaluate prognostic value of quantitative flow ratio (QFR) in drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR).
Background
There is a high incidence of recurrent ISR after DCB angioplasty. QFR is a novel method for fast computation of fractional flow reserve for the target vessel based on quantitative coronary angiography (QCA) and fluid dynamics algorithms.
Methods
Patients participating in the RESTORE ISR China randomized trial were enrolled and classified into the recurrent restenosis group and the non-recurrent restenosis group. The binary classifications followed the QCA standards of ISR. Clinical and angiographic characteristics of the groups were analyzed, and the QFRs before and after lesion preparation and after final DCB angioplasty were measured and compared.
Results
A total of 208 patients who underwent follow-up angiography were enrolled in the study, with 226 lesions measured in total. QFR value after DCB angioplasty (odds ratio [OR] 0.88; 95% confidence interval [CI] 0.83-0.93; p < .0001 for 1 mm increase), lesion length (OR: 1.08; 95% CI: 1.01-1.15; p = .017), and vessel caliber lumen diameter (OR: 0.35; 95% CI 0.13-0.89; p = .027) were independently associated with recurrent restenosis after DCB angioplasty. The optimal QFR cut-off value was determined to be 0.90 with a sensitivity of 0.94, specificity of 0.56, and accuracy of 0.79 in predicting recurrent restenosis.
Conclusions
The QFR value after DCB angioplasty is a promising predictor of DES ISR.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 19 Mar 2021; epub ahead of print

A randomized comparison of two paclitaxel-coated balloons for the treatment of in-stent restenosis: The LONGTY ISR China randomized trial (LONGTY DCB vs. SeQuent Please DCB).

Hu P, Sun Y, Li CL, Jin R, ... Wang JA, Jiang J
Objectives
This study sought to compare the efficacy and clinical safety of the LONGTY drug-coated balloon (DCB) with those of SeQuent Please DCB in patients with in-stent restenosis (ISR).
Background
Although DCB technologies have evolved, little is known about the clinical efficacy of the new-generation LONGTY DCB.
Methods
This was a prospective, multicenter, randomized, noninferiority trial comparing LONGTY DCB with SeQuent Please DCB in patients with ISR. The primary endpoint was target lesion late lumen loss at 9 months\' follow-up.
Results
A total of 211 patients with ISR from 13 Chinese sites were included (LONGTY DCB, n = 105; SeQuent Please DCB, n = 106). Device success was achieved in all patients. At the 9 month angiographic follow-up, target lesion late lumen loss was 0.35 ± 0.42 mm with LONGTY and 0.38 ± 0.45 mm with SeQuent Please (p for noninferiority <.001). The target lesion revascularization rates at 1 year were similar in both DCB groups (15.24 vs. 13.21%; p = .673). Over an extended follow-up of 2 years, the clinical endpoints, including cardiac death, myocardial infarction, and thrombus rate, were extremely low and similar in both groups.
Conclusions
In this multicenter, head-to-head, randomized trial, the new-generation LONGTY DCB was noninferior to the SeQuent Please DCB for the primary endpoint of target lesion late lumen loss at 9 months.

© 2021 Wiley Periodicals LLC.

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

Preliminary findings on the use of intravascular ultrasound in the assessment of pediatric pulmonary vein stenosis.

Callahan R, Jenkins KJ, Gauthier Z, Gauvreau K, Porras D
Objective
Determine the feasibility of performing intravascular ultrasound (IVUS) in pediatric pulmonary vein stenosis (PVS) and investigate whether IVUS can delineate the mechanism of PVS.
Background
The use of IVUS in pediatric patients with PVS has not been reported.
Methods
Retrospective, single center, cohort analysis of all patients who underwent IVUS of pulmonary veins from August 2016 to December 2019.
Results
IVUS was performed on 81 pulmonary veins in 50 pediatric patients (median age = 1.7 years [0.9, 3.1], median weight = 8.6 kg [7.3, 11.8]). All veins accepted the IVUS catheter (.014 or .018), with adequate visualization in 88% (71/81) of imaged veins, and improvement in visualization in the more recent period (23/24; 96%). Veins were categorized as having presumed intimal thickening (PIT) with luminal narrowing (n = 36), ostial narrowing without PIT (n = 14), distortion/compression (n = 6), normal (n = 2), and stent with (n = 9) or without in-stent stenosis (n = 4). In veins with at least 6 months of follow up, (re)intervention occurred more commonly in veins with PIT (14/19; 74%) versus veins without PIT (3/13; 23%; p = 0.01). There were no IVUS related adverse events.
Conclusion
IVUS can be used safely in pediatric patients and can reliably demonstrate vein lumen and wall architecture. With further refinement, IVUS has the potential to differentiate intimal neo-proliferation from other mechanisms of obstruction. The exact role of IVUS in the assessment of pediatric PVS is yet to be determined.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Mar 2021; 97:E362-E370

Direct EBUS-guided transtracheal lymphosclerosis for plastic bronchitis after Fontan.

Hubrechts J, Dooms C, Maleux G, Gewillig M
We report on a new puncture technique with direct transtracheal mediastinal lymphatic access to treat plastic bronchitis after Fontan repair. High resolution contrast-enhanced spiral CT identified enlarged lymph nodes in the paratracheal region. Inguinal intranodal Gadolinium Dynamic Contrast-enhanced Magnetic Resonance lymphangiography (DCMRL) confirmed the pathologic centrifugal lymph flow passing through these lymph nodes before leaking into the bronchial tree. The abnormal hypertrophic paratracheal, subcarinal, and hilar lymph nodes were punctured with a 22G needle through an endobronchial ultrasound bronchoscope. Occlusion of the lymph vessels was obtained by injecting a mixture of lipiodol/NBCA N-butyl cyanoacrylate (Histoacryl) 5/1 under fluoroscopic control. There was a total remission of PB with now 10 months of follow-up.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Mar 2021; 97:E371-E375

Clinical impact of intravascular ultrasound-guided balloon angioplasty in patients with chronic limb threatening ischemia for isolated infrapopliteal lesion.

Soga Y, Takahara M, Ito N, Katsuki T, ... Tomoi Y, Ando K
Background
To estimate the impact of intravascular ultrasound (IVUS) in patients with chronic limb-threatening ischemia (CLTI) who underwent balloon angioplasty for isolated infrapopliteal lesion.
Methods
The study was performed as a single-center, prospective maintained database, retrospective analysis. Between January 2013 and December 2018, consecutive 155 CLTI patients (155 limbs) who primarily underwent balloon angioplasty for de novo isolated infrapopliteal atherosclerotic lesions with Rutherford category class 4 or 5 were identified (IVUS-guided: 92 patients, angio-guided: 63 patients) and included in the analysis. We compared clinical outcomes in IVUS-guided group with that in angio-guided group. The primary endpoint was limb salvage without any reintervention. The main secondary endpoints were wound healing rate and time to wound healing in the tissue loss group.
Result
Patient and limb characteristics were similar between the two groups. The IVUS-guided group was treated with a larger balloon size for all types of below-the-knee vessel (p < .001), although lesion characteristics, including the QVA-measured vessel diameter, were similar between the two groups. The IVUS-guided group had a higher rate of limb salvage without any reintervention than the angio-guided group (p = 0028). Whereas limb salvage and overall survival was not significantly different. Wound healing was significantly earlier and the time to wound healing was significantly shorter (84 ± 55 days vs. 135 ± 118 days, p = .007) in the IVUS-guided group.
Conclusion
Limb salvage rate without any reintervention in IIVUS-guided balloon angioplasty group was significantly higher than that in angio-guided balloon angioplasty group in patients with CLTI due to isolated infrapopliteal disease.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Mar 2021; 97:E376-E384

A systematic review and meta-analysis of the performance of flow-diverting stents in the treatment of peripheral and visceral artery aneurysms.

Zhang Y, Xiang D, Lu Q, Wu M, Cui J
Objective
This meta-analysis aims to evaluate the safety and efficacy of flow-diverting stents (FDS) in treating peripheral and visceral artery aneurysms (PAA/VAAs).
Background
Though rare, PAA/VAAs can represent a life-threatening condition due to their propensity of rupture. The FDS emerges as a new solution to exclude these aneurysms while maintaining collateral branches, but convincing evidence is lacking on its clinical effectiveness.
Methods
A systematic literature search was performed to identify studies related to FDS in treating PAA/VAAs. The preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement was applied to guide the data extraction, quality assessment, and synthesis of outcomes of interest. Random effect models were applied to calculate the event rates of major endpoints. OpenMeta[Analyst] software was used for statistical analysis.
Results
Of 130 records screened, 10 cohort studies (including 220 patients, average age: 66.0 years, 78.4% male) were enrolled in the meta-analysis. Pooled data suggested a technical success rate of 98.5% (95% CI: 97.0-100%). During a mean follow-up period of 14.1 months, 93.6% (95% CI: 88.6-98.5%) side branches remained patent, 89.8% (95% CI: 84.3-95.3%) aneurysms were totally thrombosed, whereas shrinkage/stabilization of the aneurysm was documented in 93.4% (95% CI: 88.4-98.4%) cases. The primary stent patency rate was estimated to be 87.9% (95% CI: 81.0-94.8%). Overall clinical success was achieved in 83.2% (95% CI: 74.4-92.0%) patients.
Conclusions
The FDS features a potential advantage of preserving side branches while inducing sac thrombosis and aneurysm shrinkage/stabilization. Further prospective, comparative studies in larger patient cohorts are anticipated to draw a robust conclusion.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Mar 2021; 97:461-469

Mortality and functional outcomes of endovascular stroke therapy in the United States.

Alqahtani F, Osman M, Harris AH, Hohmann SF, Alkhouli M
Background
We sought to evaluate the nationwide trends in the characteristics and outcomes of for endovascular stroke therapy in contemporary practice.
Methods
We selected patients with acute ischemic stroke who underwent endovascular stroke therapy between 01 October 2015 and 30 September 2019 in a large academic consortium database. The end points of this study were (a) in-hospital mortality and functional outcomes and, (b) predictors of poor functional outcome, defined as death or discharge to hospice, or to a long-term nursing facility.
Results
Among the 22,193 included patients; 50.3% were females, and 66.5% were white. Mean age was 68±15 years. Poor functional outcomes occurred in 8,274 patients (37.4%), of whom 2,741 (12.4%) died in the hospital, 1,345 (6.1%) were discharged to hospice, and 4,188 (18.9%) were discharged to other long-term facilities. Most common in-hospital complications were mechanical ventilation (32.3%), intracranial hemorrhage (18.9%), and acute kidney injury (15.6%). Median total and intensive-care length-of-stay were 7 days (IQR = 4-9), and 2 days (IQR = 1-4), respectively. Median cost was $36,609 (IQR = $26,034-$54,313). In a multi-logistic regression analysis; age, hypertension, diabetes, anemia, heart failure, vascular disease, chronic pulmonary disease, renal insufficiency, Medicare/medicaid insurance, transfer from nonendovascular capable hospital, and low procedural volume independently predicted poor functional outcomes. Tissue plasminogen activator use was associated with better functional outcomes.
Conclusion
There is a substantial growth in the performance of endovascular stroke interventions in the United States in recent years, and those were associated with favorable short-term outcomes.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Mar 2021; 97:470-474

Outcome of PCI with Xience versus other commonly used modern drug eluting stents: A SCAAR report.

Grimfjärd P, Bergman E, Buccheri S, Erlinge D, ... Angerås O, James S
Objectives
To analyze the clinical outcome of percutaneous coronary intervention (PCI) using the Xience drug eluting stent (DES) versus other modern DES.
Methods
This retrospective study based on the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) analyzed the outcome of PCI using Xience versus other commonly used modern DES, 2007 to 2017. The primary outcome measure was a combination of all-cause death, myocardial infarction (MI) and revascularisation with PCI. Angiographical outcome measures were in-stent restenosis (ISR) and stent thrombosis (ST).
Results
Rates of the primary outcome measure for Xience and other DES were 31.9% and 28.2% respectively, adjusted hazard ratio (HR) 0.99 (95% CI 0.95-1.03). Crude rates of ISR were 2.9% versus 2.1% over 4.3 and 2.9 years respectively, adjusted HR 0.93 (95% CI 0.81-1.06). Crude rates of ST were 0.9% versus 0.7%, adjusted HR 1.07 (95% CI 0.82-1.39). Results were consistent in all sensitivity analyses.
Conclusions
This nationally complete, real-world study confirms that Xience is a safe and effective DES with low-event rates of ISR and ST. Compared with a control group containing a large proportion of thinner strut stents and absorbable polymers, Xience exhibits similar results in all important clinical endpoints.

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

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

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: 12 Mar 2021; epub ahead of print