Journal: Catheter Cardiovasc Interv

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Abstract

Contemporary diagnosis and management of severe tricuspid regurgitation.

Zahr F, Chadderdon S, Song H, Sako E, ... Bailey SR, Cigarroa J
Many novel percutaneous interventions are being developed for application in the tricuspid valve position. At the present time in the United States, there are no commercially available transcathter devices for this application. This article reviews the growing evidence for diagnosing, imaging, and treating severe tricuspid regurgitation as well as the surgical and transcatheter options that are under current development and in various stages of clinical trials.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 10 Sep 2022; epub ahead of print
Zahr F, Chadderdon S, Song H, Sako E, ... Bailey SR, Cigarroa J
Catheter Cardiovasc Interv: 10 Sep 2022; epub ahead of print | PMID: 36086951
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Abstract

Incidence and outcomes of cardiogenic shock among women with spontaneous coronary artery dissection.

Osman M, Syed M, Simpson TF, Bhardwaj B, ... Zahr F, Cigarroa JE
Background
There is a paucity of data on cardiogenic shock (CS) incidence and outcomes among patients with spontaneous coronary artery dissection (SCAD).
Methods
Women admitted to the hospital for acute myocardial infarction (AMI) with and without SCAD were identified from the United States National Readmission Database from October 1, 2015 to December 31, 2018. We calculated the incidence of CS among women with AMI with and without SCAD and odds for developing CS after adjusting for baseline characteristics. In addition, we report the utilization of percutaneous coronary intervention, mechanical circulatory support, severe disability surrogates, and 30-day readmission rates.
Results
A total of 664,292 patients admitted for AMI were eligible for analysis, including 6643 patients with SCAD and 657,649 without SCAD. Patients with SCAD were younger (57 years [interquartile range, IQR 48-68] vs. 71 years [IQR 60-81], p < 0.01) and had fewer comorbidities yet had a higher incidence of CS as compared to patients without SCAD (9% vs. 5%, p < 0.01) and remained at elevated risk after adjusting for baseline comorbidities (adjusted odds ratio 1.5 [95% confidence interval, CI 1.2-1.7]). Among patients who developed CS, those with SCAD had lower in-hospital mortality than non-SCAD (31% vs. 39%, p < 0.01), and were more likely to receive mechanical circulatory support.
Conclusions
In a nationally representative sample of women admitted for AMI, we found that patients with SCAD had a higher risk of developing CS and required more frequent use of mechanical circulatory support but were more likely to survive to discharge than women suffering AMI from causes other than SCAD.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Sep 2022; epub ahead of print
Osman M, Syed M, Simpson TF, Bhardwaj B, ... Zahr F, Cigarroa JE
Catheter Cardiovasc Interv: 08 Sep 2022; epub ahead of print | PMID: 36073664
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Abstract

Procedural and long-term outcome among patients undergoing expedited trans-catheter aortic valve replacement.

Berkovitch A, Segev A, Guetta V, Finkelstein A, ... Orvin K, Barbash IM
Objective
Patients with rapidly deteriorating clinical status due to severe aortic stenosis are often referred for expedited transcatheter aortic valve replacement (TAVR). Data regarding the outcome of such interventions is limited. We aimed to evaluate the outcome of patients undergoing expedited TAVR.
Design and setting
Data were derived from the Israeli Multicenter Registry.
Subjects
Subjects were divided into two groups based on procedure urgency: patients who were electively hospitalized for the procedure (N = 3140) and those who had an expedited TAVR (N = 142). Procedural and periprocedural complication rates were significantly higher among patients with an expedited indication for TAVR compared to those having an elective procedure: valve malposition 4.6% versus 0.6% (p < 0.001), procedural cardiopulmonary resuscitation 4.3% versus 1.0% (p = 0.007), postprocedure myocardial infarction 2.0% versus 0.4% (p = 0.002), and stage 3 acute kidney injury 3.0% versus 1.1%, (p < 0.001). Patients with expedited indication for TAVR had significantly higher in hospital mortality (5.6% vs. 1.4%, p = 0.003). Kaplan-Meier\'s survival analysis showed that patients undergoing expedited TAVR had higher 3-year mortality rates compared to patients undergoing an elective TAVR procedure (p < 0.001). Multivariate analysis found that patients with expedited indication had fourfolds increased risk of in-hospital mortality (odds ratio: 4.07, p = 0.001), and nearly twofolds increased risk of mortality at 3-year (hazard ratio: 1.69, p = 0.001) compared to those having an elective procedure.
Conclusion
Patients with expedited indications for TAVR suffer from poor short- and long-term outcomes. It is important to characterize and identify these patients before the deterioration to perform TAVR in a fast-track pathway to minimize their procedural risk.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 18 Sep 2022; epub ahead of print
Berkovitch A, Segev A, Guetta V, Finkelstein A, ... Orvin K, Barbash IM
Catheter Cardiovasc Interv: 18 Sep 2022; epub ahead of print | PMID: 36116033
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Abstract

Real-world VASCADE closure device versus manual compression use and outcomes in patients with severe common femoral artery disease.

Nagpal S, Scierka LE, Castro-Dominguez Y, Kansal D, ... Smolderen KG, Mena-Hurtado C
Background
The VASCADE closure device deploys an extravascular collagen plug. Its use in those with access site disease undergoing peripheral vascular intervention (PVI) is unknown. We aimed to evaluate the efficacy and safety of the VASCADE closure device compared to manual compression (MC) in patients with moderate femoral access site disease.
Methods
We performed a single-center, retrospective review of patients undergoing PVI with at least moderate access site disease. Our institutional database was linked to the Vascular Quality Initiative database, and 200 patients were selected from a 1:1 propensity-matched cohort. Data on procedural metrics and outcomes up to 30-days were abstracted.
Results
There were 103 procedures that used VASCADE and 97 used MC. Baseline variables were similar between groups. The mean age was 68.2 ± 11.2 years and 37.6% were women. Closing mean activated clotting time (ACT) was shorter in VASCADE (198 s VASCADE vs. 213 s MC; p = 0.018). There was a nonsignificant decrease in external compression device use with VASCADE (VASCADE 19.0% vs. MC 28.1%; p = 0.15). At 30-days, there was a nonsignificant reduction in hematoma with VASCADE (3.8% vs. 7.8% MC; p = 0.25) and no difference in retroperitoneal bleeding (0.5%). Pseudoaneurysm rate was similar (1.3% VASCADE vs. 1.7% MC; p = 0.79). The 30-day mortality rate was similar between the two groups and not related to the procedure (1.3% VASCADE vs. 0.9% MC; p = 0.79).
Conclusion
In patients undergoing PVI with at least moderate access site disease, safety and efficacy after using VASCADE was comparable with MC.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 21 Sep 2022; epub ahead of print
Nagpal S, Scierka LE, Castro-Dominguez Y, Kansal D, ... Smolderen KG, Mena-Hurtado C
Catheter Cardiovasc Interv: 21 Sep 2022; epub ahead of print | PMID: 36129818
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Abstract

False lumen patency status and outcomes after endovascular repair of uncomplicated chronic type B dissection.

Kong M, Ni M, Zhu X, Qian J, ... Feng Z, Dong A
Background
Thoracic endovascular aortic repair (TEVAR) remains a controversial treatment for uncomplicated chronic type B aortic dissection (cTBAD). This study was performed to investigate the postoperative outcomes of TEVAR, such as survival and reintervention, and the risk factors for prognoses.
Methods
In total, 41 patients with uncomplicated cTBAD who underwent TEVAR from 2014 to 2021 were reviewed. The patients were divided into two groups: those with false lumen complete thrombosis (FLCT) and false lumen partial thrombosis (FLPT) based on computed tomography angiography (CTA) images. Kaplan-Meier analysis was performed to estimate survival and freedom from reintervention. Binary logistic analysis was performed to estimate risk factors for partial thrombosis.
Results
During a mean follow-up of 31 (1-78) months, five deaths and six reinterventions had occurred at 5 years. By 1 week, thoracic FLCT had occurred in 23 (56.1%) patients and thoracic FLPT had occurred in 18 (43.9%). The rate of freedom from reintervention was significantly lower in the FLCT than in the FLPT group (p = 0.04). The 5-year survival rate of the two groups was not statistically significant (p = 0.14). Risk factors for thoracic FLPT were the distance between the re-entry site and the graft (p = 0.02) and the proximal oversizing ratio (p = 0.04).
Conclusions
TEVAR is an effective and safe treatment for uncomplicated cTBAD and has a low mortality rate. Thoracic FLCT is associated with less reintervention, but overall survival is not impacted by this difference. Patients treated with TEVAR without certain risk factors can have a good prognosis.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 13 Sep 2022; epub ahead of print
Kong M, Ni M, Zhu X, Qian J, ... Feng Z, Dong A
Catheter Cardiovasc Interv: 13 Sep 2022; epub ahead of print | PMID: 36098330
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Abstract

Outcomes and challenges of the provisional stenting technique: Insights from the PROGRESS-BIFURCATION registry.

Simsek B, Kostantinis S, Karacsonyi J, Allana S, ... Rangan BV, Brilakis ES
Background
Provisional stenting is the most commonly used coronary bifurcation stenting strategy.
Methods
We examined the clinical and angiographic characteristics, challenges encountered, and procedural outcomes with the provisional bifurcation stenting strategy in the Prospective Global Registry of Percutaneous Coronary Intervention (PCI) in Bifurcation Lesions (PROGRESS-BIFURCATION, NCT05100992).
Results
Provisional stenting was used in 334 of 430 bifurcation interventions (78%). Technical success was lower (95% vs. 100%, p = 0.017) in provisional, but procedural success (90% vs. 95%, p = 0.095) and incidence of in-hospital major adverse cardiovascular events were similar (5% vs. 5%, p = 0.945) compared with two-stent strategies. Provisional was less often preferred in left main/left anterior descending involvement (47% vs. 73%, p < 0.001). Provisional stenting cases had smaller side branch (SB) diameter (2.4 ± 0.5 vs. 2.7 ± 0.6 mm, p < 0.001), shorter SB lesion length (5 [3-8] vs. 10 [5-10] mm, p < 0.001), less SB diameter stenosis (46 ± 35 vs. 81 ± 20%, p < 0.001), and were less likely to be Medina 1,1,1 (34% vs. 73%, p < 0.001). PCI challenges were less common (30% vs. 58%, p < 0.001) with provisional stenting: (1) rewiring difficulty (43%) that was overcome with use of a different wire (74%) or microcatheter (46%); (2) inability to deliver a stent (22%) or balloon (9%) that was overcome with use of a smaller balloon (88%), rewiring (25%), or increased support/microcatheter (25%).
Conclusions
Provisional bifurcation stenting was more often performed in distal lesions with less SB involvement and had lower technical success, but similar procedural success and complications compared with two-stent strategies.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 19 Sep 2022; epub ahead of print
Simsek B, Kostantinis S, Karacsonyi J, Allana S, ... Rangan BV, Brilakis ES
Catheter Cardiovasc Interv: 19 Sep 2022; epub ahead of print | PMID: 36121014
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Abstract

Predictors of 30-day and 12-month mortality in left main stem percutaneous coronary intervention 2016-2020: A study from two UK centers.

Carande EJ, Protty MB, Verhemel S, Hussein MH, ... Hussain HI, Hailan A
Introduction
Left main stem percutaneous coronary intervention (LMS-PCI) is a complex high-risk procedure which can be performed as an alternative to coronary artery bypass graft (CABG) procedure in surgical turn-down patients or where there is equipoise in percutaneous versus surgical strategies. Current guidelines suggest that PCI is an appropriate alternative to CABG in patients with unprotected LMS disease and low SYNTAX score. However, \"real world\" data on outcomes of LMS-PCI remain limited. This study aims to quantify and determine predictors of mortality following LMS-PCI.
Methods
Using local coronary angioplasty registries from two UK centers, all LMS-PCI cases were identified from 2016 to 2020. Descriptive statistics and multivariate logistic regressions were used to examine the association between baseline and procedural characteristics with 30-day and 12-month mortality.
Results
We identified 484 cases of LMS-PCI between 2016 and 2020. There was a year-on-year increase in the number of LMS-PCI, the highest being in 2020. Covariates associated with higher 30-day mortality were age (OR 1.07, 95% CI: 1.02-1.12) and shock preprocedure (OR 23.88, 95% CI: 7.90-72.20). Covariates associated with higher 12-month mortality were age (OR 1.04, 95% CI: 1.01-1.08), acute coronary syndrome (ACS) (OR 2.50, 95% CI: 1.08-5.80), renal disease (OR 5.24, 95% CI: 1.47-18.68), and shock preprocedure (OR 7.93, 95% CI: 3.30-19.05). Overall, 30-day and 12-month mortality in this contemporary data set were 9.5% and 16.7%, respectively, with significantly lower rates in elective cases (p < 0.01).
Conclusions
Older age and cardiogenic shock preprocedure were associated with increased 30-day mortality after LMS-PCI. Twelve-month mortality was associated with older age, ACS presentation, preexisting renal disease, and cardiogenic shock preprocedure.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Sep 2022; epub ahead of print
Carande EJ, Protty MB, Verhemel S, Hussein MH, ... Hussain HI, Hailan A
Catheter Cardiovasc Interv: 14 Sep 2022; epub ahead of print | PMID: 36104863
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Abstract

Impact of extracardiac vascular disease on outcomes of 1.4 million patients undergoing percutaneous coronary intervention.

Bashar H, Matetić A, Curzen N, Mamas MA
Objectives
Extracardiac vascular disease (ECVD) is increasingly recognized as a cardiovascular risk factor, but its association with outcomes after percutaneous coronary intervention (PCI) has not been well characterized.
Methods
Using the National Inpatient Sample database, all patients undergoing PCI between October 2015 and December 2018 were stratified by the presence and organ-specific extent of extracardiac vascular comorbidity (cerebrovascular disease (CeVD), renovascular, aortic and peripheral arterial disease (PAD)). Primary outcome was all-cause mortality and secondary outcomes were (a) major adverse cardiovascular and cerebrovascular events (MACCE), (b) acute ischemic stroke and (c) major bleeding. Multivariable logistic regression was used to determine the adjusted odds ratios (aOR) and 95% confidence interval (95% CI).
Results
Of a total of 1,403,505 patients undergoing PCI during the study period, 199,470 (14.2%) had ECVD. Patients with ECVD were older (median of 72 years vs. 70 years, p < 0.001) and had higher comorbidity burden that their counterparts. All cause-mortality was 22% higher in patients with any ECVD compared to those without ECVD. PAD patients had the highest odds of all-cause mortality (aOR 1.48, 95% CI 1.40-1.56), followed by those with CeVD (aOR 1.15, 95% CI 1.10-1.19). Patients with extracardiac disease had increased odds of MACCE, ischemic stroke and bleeding, irrespective of the nature or extent (p < 0.05), compared to patients without ECVD.
Conclusion
ECVD is associated with worse outcomes in patients undergoing PCI including significantly higher rates of death and stroke. These data should inform our shared decision-making process with our patients.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 21 Sep 2022; epub ahead of print
Bashar H, Matetić A, Curzen N, Mamas MA
Catheter Cardiovasc Interv: 21 Sep 2022; epub ahead of print | PMID: 36129816
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Abstract

Failure patterns after intravascular brachytherapy for in-stent coronary restenosis.

Wallner K, Kearney KE, Kim M, Tiwana J, ... Phillips ML, Don C
Introduction
One strategy to improve the effectiveness of intravascular brachytherapy (IVBT) is to study its failures. Previous investigations described mostly discrete, focal recurrences, typically at the proximal or distal edges of the irradiated segment after plain angioplasty or bare metal stents. We reviewed failure patterns of 30 unselected drug-eluting stent (DES) patients who had follow-up angiograms for recurrence within their IVBT-treated vessel.
Methods
Records of 53 unselected IVBT patients treated between 2016 and 2021 were reviewed. Thirty of the 53 patients had at least one subsequent percutaneous intervention (PCI) for in-stent restenosis (ISR) after IVBT. Angiographic findings of those 30 patients with ISR within their previously irradiated vessel are reported here.
Results
Of the 30 patients, 21 (70%) developed recurrent ISR within the irradiated segment. Six of the 21 patients who failed within the irradiated segment also experienced ISR proximal or distal to the irradiated segment. Only 15 patients (50%) failed exclusively within the irradiated segment. In nine patients (30%), restenosis occurred proximally and/or distally to the irradiated segment, but not inside of the irradiated segment itself.
Conclusions
We have shown here that 50% of failures after coronary IVBT for DES ISR occur exclusively within the irradiated segment. An additional 20% of patients had failure within and outside of the irradiated segment. These percentages suggest that a higher radiation dose might improve the long-term patency rates, a conclusion that should be tempered by the lack of universal follow-up.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 13 Sep 2022; epub ahead of print
Wallner K, Kearney KE, Kim M, Tiwana J, ... Phillips ML, Don C
Catheter Cardiovasc Interv: 13 Sep 2022; epub ahead of print | PMID: 36098336
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Abstract

Two-year outcomes after transcatheter aortic valve-in-valve implantation in degenerated surgical valves.

Abushouk AI, Abdelfattah O, Gad MM, Saad A, ... Johnston DR, Kapadia SR
Background
Transcatheter aortic valve-in-valve implantation (ViV-TAVI) has emerged in recent years as a safe alternative to redo surgery in high-risk patients. Although early results are encouraging, data beyond short-term outcomes are lacking. Herein, we aimed to assess the 2-year outcomes after ViV-TAVI.
Methods
Patients undergoing ViV-TAVI for degenerated surgical valves between 2013 and 2019 at the Cleveland Clinic were reviewed. The coprimary endpoints were all-cause mortality and congestive heart failure (CHF) hospitalizations. We used time-to-event analyses to assess the primary outcomes. Further, we measured the changes in transvalvular gradients and the incidence of structural valve deterioration (SVD).
Results
One hundred and eighty-eight patients were studied (mean age = 76 years; 65% males). At 2 years of follow-up, all-cause mortality and CHF hospitalizations occurred in 15 (8%) and 28 (14.9%) patients, respectively. On multivariable analysis, the postprocedural length of stay was a significant predictor for both all-cause mortality (hazard ratio [HR] = 1.1; 95% confidence interval [CI]: 1.01, 1.19) and CHF hospitalization (HR = 1.16; 95% CI: 1.07, 1.27). However, the internal diameter of the surgical valve was not associated with significant differences in both primary endpoints. For hemodynamic outcomes, nine patients (4.8%) developed SVD. The mean and peak transvalvular pressure gradients remained stable over the follow-up period.
Conclusion
ViV-TAVI for degenerated surgical valves was associated with favorable 2-year clinical and hemodynamic outcomes. Further studies are needed to better understand the role of ViV-TAVI as a treatment option in the life management of aortic valve disease.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 18 Sep 2022; epub ahead of print
Abushouk AI, Abdelfattah O, Gad MM, Saad A, ... Johnston DR, Kapadia SR
Catheter Cardiovasc Interv: 18 Sep 2022; epub ahead of print | PMID: 36116028
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Abstract

Extraplaque versus intraplaque tracking in chronic total occlusion percutaneous coronary intervention.

Megaly M, Buda K, Karacsonyi J, Kostantinis S, ... Alaswad K, Brilakis ES
Objective
To compare the clinical outcomes after extraplaque (EP) versus intraplaque (IP) tracking in chronic total occlusion (CTO) percutaneous coronary intervention (PCI).
Background
The impact of modern dissection and reentry (DR) techniques on the long-term outcomes of CTO PCI remains controversial.
Methods
We performed a systematic review and meta-analysis of studies that compared EP versus IP tracking in CTO PCI. Odds ratios (ORs) with 95% confidence intervals (CIs) are calculated using the Der-Simonian and Laird random-effects method.
Results
Our meta-analysis included seven observational studies with 2982 patients. Patients who underwent EP tracking had significantly more complex CTOs with higher J-CTO score, longer lesion length, and more severe calcification and had significantly longer stented segments. During a median follow-up of 12 months (range 9-12 months), EP tracking was associated with a higher risk of major adverse cardiovascular events (MACE) (OR 1.50, 95% CI (1.10-2.06), p = 0.01) and target vessel revascularization (TVR) (OR 1.69, 95% CI (1.15-2.48), p = 0.01) compared with IP tracking. There was no difference in the incidence of all-cause death (OR 1.37, 95% CI (0.67-2.78), p = 0.39), myocardial infarction (MI) (OR 1.48, 95% CI (0.82-2.69), p = 0.20), stent thrombosis (OR 2.09, 95% CI (0.69-6.33), p = 0.19), or cardiac death (OR 1.10, 95% CI (0.39-3.15), p = 0.85) between IP and EP tracking.
Conclusion
EP tracking is utilized in more complex CTOs and requires more stents. EP tracking is associated with a higher risk of MACE, driven by a higher risk of TVR at 1 year, but without an increased risk of death or MI compared with IP tracking. EP tracking is critically important for contemporary CTO PCI.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 28 Sep 2022; epub ahead of print
Megaly M, Buda K, Karacsonyi J, Kostantinis S, ... Alaswad K, Brilakis ES
Catheter Cardiovasc Interv: 28 Sep 2022; epub ahead of print | PMID: 36168859
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Abstract

Trends in invasive treatment of patients hospitalized with aortic stenosis complicated by cardiogenic shock.

Elkaryoni A, Cohen DJ, Lopez JJ, Huded CP, Kennedy KF, Arnold SV
Background
Before the development of transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty (BAV) was the only potential nonsurgical intervention for patients with aortic stenosis complicated by cardiogenic shock. Emergent TAVR is now an option and has shown acceptable outcomes compared with elective TAVR. We explored how treatment patterns for aortic stenosis and cardiogenic shock among patients received invasive intervention have shifted since TAVR was introduced.
Methods
We used the Nationwide In patients Sample to identify nonelective hospitalizations for patient with aortic stenosis complicated by cardiogenic shock who received invasive treatment (TAVR, BAV, or surgical aortic valve replacement [SAVR]). We explored the proportion treated with each treatment modality over time, the patient characteristics and in-hospital mortality associated with each treatment, and used multivariable logistic regression to examine whether changes in in-hospital mortality over time differed by treatment.
Results
Between 2010 and 2019, we identified 9899 hospitalizations for decompensated aortic stenosis with cardiogenic shock during which patients received invasive treatment (TAVR 17.7%, BAV 20.2%, SAVR 62.1%). Use of both TAVR and BAV has increased over time compared with SAVR (TAVR 6.6% ≥ 33.8%, BAV 8.4% ≥ 23.2%, SAVR 91.6% ≥ 43.0%; p < 0.001 for trend). The overall in-hospital mortality rate was 21.0%, which decreased over time for all treatments (TAVR 20.0% ≥ 18.8%, BAV 66.0% ≥ 25.5%, SAVR 17.7% ≥ 11.8%; linear trend p < 0.001 for each), with lower mortality for TAVR versus BAV at all time points. Patients treated with TAVR (vs. BAV) were less likely to require mechanical ventilation (36.8% vs. 46.3%, p < 0.001) or mechanical circulatory support (22.5% vs. 29.9%, p < 0.001). In the multivariable analysis, the interaction between treatment and time was not significant (p = 0.245), indicating the reduction in in-hospital mortality over time did not differ among the treatments.
Conclusions
Since the introduction of TAVR, there has been a shift toward increased use of nonsurgical invasive treatments (both BAV and TAVR) for aortic stenosis and cardiogenic shock. Although in-hospital mortality has declined, it remains high in all groups, but particularly among patients treated with BAV, where the severity of cardiogenic shock appears to be higher than in those treated with other modalities.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 28 Sep 2022; epub ahead of print
Elkaryoni A, Cohen DJ, Lopez JJ, Huded CP, Kennedy KF, Arnold SV
Catheter Cardiovasc Interv: 28 Sep 2022; epub ahead of print | PMID: 36168864
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Abstract

Alcohol septal ablation for left ventricular outflow tract obstruction in cardiac amyloidosis: New indication for an established therapy.

Fanta LE, Ewer SM, Gimelli G, Reilly NM
Cardiac amyloidosis can occasionally demonstrate an atypical pattern of infiltration, causing asymmetric septal thickening and a left ventricular outflow tract (LVOT) gradient with systolic anterior motion (SAM) of the mitral valve resembling obstructive hypertrophic cardiomyopathy. We present a case of a 70-year-old man with cardiac light-chain amyloidosis and LVOT obstruction successfully treated with alcohol septal ablation (ASA). Following the procedure, he reported significant improvement in his heart failure symptoms as well as improvement in LVOT gradient and SAM of the mitral valve. This case demonstrates that ASA is a technically feasible and effective procedure for relieving LVOT obstruction in cardiac amyloidosis and can be considered as a treatment option in patients whose symptoms are refractory to medical therapy.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 24 Sep 2022; epub ahead of print
Fanta LE, Ewer SM, Gimelli G, Reilly NM
Catheter Cardiovasc Interv: 24 Sep 2022; epub ahead of print | PMID: 36153647
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Abstract

Bespoke valve sizing avoids annular rupture in patients treated with a balloon-expandable transcatheter heart valve.

Chavarria J, Falcao F, Dutra G, Sathananthan J, ... Velianou J, Sheth T
Background
Annular and left ventricular outflow tract (LVOT) calcification increase the risk of annular rupture following transcatheter aortic valve replacement (TAVR). The outcomes of a strategy of routine use of a balloon-expandable valve (BEV) for all patients irrespective of annular or LVOT calcium is unknown.
Objectives
We evaluated the impact of bespoke sizing on annular rupture in patients treated with a BEV.
Methods
All consecutive patients undergoing TAVR at a single centre (February 2020-February 2022) were treated only with a BEV. No other valve design was used. Annular/LVOT calcification was assessed using a standardized grading system. For each annular area, we determined the percentage valve oversizing with nominal deployment. The balloon deployment volume was then adjusted when required (over-/underfilled) to achieve over-sizing of approximately 5% in the presence of annular/LVOT calcium and 5%-10% in the absence of annular/LVOT calcium. Adjusted valve areas were assumed to change proportionately to the change in balloon deployment volume.
Results
Among 533 TAVR treated patients, annular/LVOT calcification was present in 166 (31.1%) and moderate or severe in 90 (16.9%). In patients with annular/LVOT calcification, the adjusted oversizing was 3.5 ± 3.6% and in patients without annular/LVOT calcification, the adjusted oversizing was 6.8 ± 4.7% (p < 0.001). There were no cases of annular rupture and no cases with more than mild paravalvular leak (PVL). Mild PVL was more frequent in patients with annular/LVOT calcium (10.8% vs 4.6%, p = 0.01).
Conclusion
Bespoke BEV sizing by adjustment of balloon deployment volume avoided annular rupture in patients undergoing TAVR.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 24 Sep 2022; epub ahead of print
Chavarria J, Falcao F, Dutra G, Sathananthan J, ... Velianou J, Sheth T
Catheter Cardiovasc Interv: 24 Sep 2022; epub ahead of print | PMID: 36153648
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Impact:
Abstract

Evaluation of safety and efficacy of the S.M.A.R.T.® Flex Vascular Stent System (OPEN study).

Gray WA, Cardenas J, Teigen CL
Objectives
The OPEN study evaluated the safety and efficacy of the S.M.A.R.T.® Flex Vascular Stent System in patients with femoropopliteal arterial disease.
Background
Long-term data on endovascular treatments of femoropopliteal arterial disease are required to establish the repair durability.
Methods
The OPEN study was a multicenter, single-arm, prospective study comparing primary safety and efficacy outcomes to performance goals (PG) developed for bare nitinol stents. Patients with symptoms due to a single, ≤180 mm length, de novo femoropopliteal arterial lesion with >70% stenosis were enrolled were enrolled and followed for 36 months. Subjects with lesions ≤150 mm served as the initial comparison cohort for the PG (other cohorts were analyzed if the PG was met).
Results
257 subjects with lesions ≤180 mm were enrolled. The mean lesion length was 71 ± 46, and 52.5% had severe claudication. The primary safety endpoint (freedom from all-cause death, index limb amputation, and target lesion revascularization [TLR] through 30 days) was met in 98.8% (96.5%, 99.6%) of subjects in the comparison cohort, meeting the PG (88.0%). The primary efficacy endpoint (comparison cohort vessel patency at 12 months) was 68.4% (61.1%, 74.8%), where the lower limit of the 95% confidence interval did not meet the 66.0% PG. Freedom from TLR in the per-protocol cohort at 12-, 24-, 36-month was 84.7%, 74.6%, and 72.8%, respectively. The 24-month stent fracture rate was 4.3%, with no new fractures identified at 36 months.
Conclusion
The results show promising long-term safety and effectiveness for the S.M.A.R.T.® Flex Vascular Stent System in patients with femoropopliteal arterial disease.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2022; epub ahead of print
Gray WA, Cardenas J, Teigen CL
Catheter Cardiovasc Interv: 29 Sep 2022; epub ahead of print | PMID: 36177491
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Impact:
Abstract

Twelve-month safety and effectiveness of TCD-17187 drug-coated balloon for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery.

Iida O, Soga Y, Seki SI, Kawasaki D, ... Nakamura M, TCD-17187 Japan Investigators
Purpose
The aim of this preapproval trial was to evaluate the 12-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery (PA).
Methods
This was a prospective, multicenter, core laboratory adjudicated, single-arm trial. From October 2019 to November 2020, a total of 121 symptomatic peripheral artery disease patients with SFA and/or proximal PA lesions were enrolled. The primary effectiveness endpoint was 12-month primary patency defined as freedom from restenosis as determined by duplex ultrasonography in the absence of clinically driven target lesion revascularization (CD-TLR). The safety endpoint was the major adverse event (MAE) rate defined as freedom from a composite of device- and procedure-related death within 30 days, and index limb major amputation and/or CD-TLR through follow-up.
Results
Average age was 74.5 ± 7.3 years and the frequency of diabetes mellitus was 67.5%. Average lesion length and vessel diameter were 106.0 ± 52.6 and 5.2 ± 0.8 mm, respectively. The frequency of chronic total occlusion and bilateral calcification was 17.5% and 50.8% of patients, respectively. The 12-month primary patency rate calculated by Kaplan-Meier analysis was 81.1%, while 12-month freedom from CD-TLR was 95.8%. The MAE rate at 30 days was 1.7% and all events comprised CD-TLR. There were no instances of device- or procedure-related deaths, major amputations, or thrombosis throughout the 12-month evaluation period.
Conclusion
This preapproval trial confirmed the safety and effectiveness of TCD-17187 DCB in the treatment of atherosclerotic lesions in the SFA and/or proximal PA.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2022; epub ahead of print
Iida O, Soga Y, Seki SI, Kawasaki D, ... Nakamura M, TCD-17187 Japan Investigators
Catheter Cardiovasc Interv: 29 Sep 2022; epub ahead of print | PMID: 36177551
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Impact:
Abstract

Usefulness of a novel sizing chart for left atrial appendage occlusion with the Amplatzer Amulet.

Freixa X, Cepas-Guillén P, Korsholm K, Kramer A, ... Jensen JM, Nielsen-Kudsk JE
Purpose
The present article aims to compare a novel sizing chart based on both maximum and minimum diameters (novel MATRIX) with the current sizing recommendation instructions for use (IFU) based on the maximum diameter.
Background
Current IFU with the Amulet device are still based on the maximum left atrial appendage (LAA) diameter, which might lead to inappropriate oversizing, especially in elliptic appendages.
Methods
This was a retrospective analysis of patients undergoing LAA occlusion in two high-volume centers. Two hundred patients were included (100 patients with baseline cardiac computed tomography angiography [CCTA] and 100 with baseline 2D and 3D-transesophageal echocardiography [TEE]). The degree of concordance between the predicted device size recommendation and the actual device selection was the primary outcome.
Results
The novel MATRIX showed a higher level of concordance between the predicted and implanted device size, regardless of imaging modalities. CCTA showed the strongest, and 2D-TEE the weakest concordance between the predicted and implanted device for both MATRIX and IFU charts. The percentage of patients in whom the disagreement among the predicted and implanted device represented >1 size was higher when using the IFU chart. In elliptical LAA anatomies, the differences favoring the use of MATRIX compared to the IFU in terms of predicted/implanted agreement were higher. Finally, no significant differences in clinical or imaging endpoints were observed between the two different sizing charts.
Conclusions
Incorporating both the LAA maximum and minimum diameters, as opposed to just maximum diameter, appears to improve sizing accuracy. The proposed MATRIX sizing chart offered a higher level of concordance between predicted and implanted device compared to the current IFU.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 24 Sep 2022; epub ahead of print
Freixa X, Cepas-Guillén P, Korsholm K, Kramer A, ... Jensen JM, Nielsen-Kudsk JE
Catheter Cardiovasc Interv: 24 Sep 2022; epub ahead of print | PMID: 36153649
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Impact:
Abstract

Initial experience with a continuous mechanical aspiration system for thrombus removal before percutaneous coronary intervention.

Mathews SJ, Brown CL, Kolski BC, Marques VM, ... Dohad SY, George JC
Objectives
Here we investigate the safety and efficacy of a continuous mechanical aspiration system when used before percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS).
Background
Historically, trials of routine manual aspiration thrombectomy in ACS patients have reported mixed results. This may be due to the technical limitations of manual aspiration, which suffers from decreasing vacuum power as aspiration is performed.
Methods
This is a retrospective case series of all patients treated with continuous mechanical aspiration (Indigo CAT RX Aspiration System; Penumbra Inc.) before PCI between August 2017 and July 2020 at five centers in the United States. Data regarding angiographic assessments, procedure, and safety were examined.
Results
Seventy-two patients (mean age 60 ± 12.5 years, 34.7% female) with ST Elevation Myocardial Infarction (STEMI) (80.6%) or Non-ST Elevation Myocardial Infarction (NSTEMI) (19.4%) were included. Target vessels were the right coronary (43.1%), left anterior descending (33.3%), and left circumflex (23.6%). Preprocedure, 94.4% had a high thrombus burden (thrombolysis in myocardial infarction [TIMI] thrombus grade ≥ 3). Median aspiration time was 35 s and median access-to-reperfusion time was 10 min. After CAT RX alone, 86.1% had complete perfusion (TIMI flow grade 3). After the procedure, 94.4% had TIMI thrombus grade <3% and 97.2% had TIMI flow grade 3. There were no cases of ischemic stroke. Cardiovascular mortality at 30 days was 1.4%.
Conclusions
In our initial experience, aspirating thrombus from ACS patients using the Indigo CAT RX Aspiration System before PCI was safe and effective for reducing thrombus burden and restoring flow.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Oct 2022; epub ahead of print
Mathews SJ, Brown CL, Kolski BC, Marques VM, ... Dohad SY, George JC
Catheter Cardiovasc Interv: 02 Oct 2022; epub ahead of print | PMID: 36183400
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Impact:
Abstract

Novel technique for transcatheter closure of sinus venosus atrial septal defect: The temporary suture-holding technique.

Hejazi Y, Hijazi ZM, Saloos HA, Ibrahim H, Mann GS, Boudjemline Y
Background
Transcatheter repair of sinus venosus atrial septal defect (SVASD) has become an alternative option to surgical repair. There are potential significant complications related to stent stability in the superior vena cava (SVC) and potential migration of the stent that need to be addressed. Therefore, the technique is still evolving.
Objectives
To report results of a new modification \"the suture technique\" that improves safety profile of positioning and securing a covered stent in the SVC.
Methods
This is a descriptive, single center, retrospective review of patients who underwent SVASD closure using the suture technique at our institution between 02/2020 and 08/2022.
Results
Fourteen patients underwent transcatheter repair of SVASD using the suture technique. All procedures were successful. The suture technique allowed precise stent placement in all patients without any migration or complication. Six patients required additional stent placement at the level of the SVC. One patient had an additional covered stent placed to eliminate a tiny residual shunt. Two patients had negligible residual shunts at the time of the procedure. At follow-up, all patients clinically improved and had significant reduction in right heart size on echocardiography and/or magnetic resonance imaging. No arrhythmia was reported in any patient. None required re-intervention after a mean follow-up of 16.5 ± SD 10.5 months.
Conclusions
The suture technique appears to be safe modification. Although our study involves small sample size with no comparative group, we believe our technique offers greater control over stent positioning, reducing the risk of stent embolization and residual shunting in transcatheter closure of SVASD.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Oct 2022; epub ahead of print
Hejazi Y, Hijazi ZM, Saloos HA, Ibrahim H, Mann GS, Boudjemline Y
Catheter Cardiovasc Interv: 02 Oct 2022; epub ahead of print | PMID: 36183408
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Impact:
Abstract

Trends, predictors, and outcomes of transcatheter aortic valve implantation in patients with bicuspid aortic valve related disease: Insights from the Nationwide Inpatient Sample and Nationwide Readmission Database.

Ullah W, Zahid S, Muhammadzai H, Khalil F, ... Shah P, Bhatt DL
Background
Transcatheter aortic valve implantation (TAVI) has increasingly been utilized in patients with bicuspid aortic valve (BAV) related aortic stenosis (AS) with insufficient large-scale data on its safety.
Methods
The Nationwide Inpatient Sample and Nationwide Readmission Database (2011-2018) were queried to identify patients undergoing TAVI for BAV versus trileaflet aortic valve (TAV) associated AS. The in-hospital, 30- and 180-day odds of outcomes were assessed using a propensity-matched analysis (PSM) to calculate adjusted odds ratios (aOR) with its 95% confidence interval (CI).
Results
A total of 216,723 TAVI (TAV: 214,050 and BAV: 2,673) crude and 5,347 matched population (TAV: 2,674 and BAV: 2,673) was included in the final analysis. At index admission, the adjusted odds of in-hospital mortality (aOR: 1.57, 95% CI: 0.67-3.66), stroke (aOR: 0.77, 95% CI: 0.38-1.57), cardiac tamponade (aOR: 0.75, 95% CI: 0.17-3.36), vascular complications (aOR: 0.33, 95% CI: 0.09-1.22), cardiogenic shock (aOR: 1.77, 95% CI: 0.93-3.38), paravalvular leak (aOR: 0.55, 95% CI: 0.26-1.14), need for mechanical circulatory support device, and permanent pacemaker implantation (PPM) (aOR: 1.02, 95% CI: 0.69-1.52) were not significantly different between TAVI for BAV versus TAV. At 30- and 180-day follow-up duration, the risk of stroke and major postprocedural complications remained similar, except that TAVI in BAV had a higher incidence of PPM implantation compared with TAV. The yearly trend showed an increase in the utilization of TAVI for both TAV and BAV and a steady decline in the overall annual rate of in-hospital complications.
Conclusion
TAVI utilization in patients with BAV has increased over the recent years. The relative odds of in-hospital mortality, and all other major complications, were similar between patients undergoing TAVI for BAV- and TAV-related AS.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Oct 2022; epub ahead of print
Ullah W, Zahid S, Muhammadzai H, Khalil F, ... Shah P, Bhatt DL
Catheter Cardiovasc Interv: 02 Oct 2022; epub ahead of print | PMID: 36183395
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Impact:
Abstract

Reducing use of triple therapy after percutaneous coronary intervention: Results from a hospital-wide quality improvement initiative.

Earle W, Abdallah G, Meagher S, Shen K, ... Ho KKL, Secemsky EA
Background
Trials have shown that for patients on oral anticoagulants (OAC), a short course of dual antiplatelet therapy (DAPT) with OAC reduces post-percutaneous coronary intervention (PCI) bleeding without increasing ischemic events. Adoption of this strategy has been variable. We evaluated the impact of an institutional quality improvement (QI) initiative to reduce the use of triple therapy (TT, OAC + DAPT) and improve discharge communication post-PCI.
Methods
A hospital-wide QI initiative was developed to minimize time on TT post-PCI. Interventions included institutional guidelines emphasizing discharge on OAC with a P2Y12 inhibitor or reducing TT duration to ≤30 days, changes to the computerized decision-support system, and an educational curriculum for house staff. PCI patients 18 months before and after the initiative (2017-2020) were reviewed along with a faculty survey assessing prescribing practices to evaluate the efficacy of the interventions.
Results
Among 2797 PCIs reviewed, 431 were included based on OAC at discharge: 24.9% female, 80.1% White, and the mean age was 74 years. The most common indications for OAC were atrial fibrillation (70.1%) and left ventricular dysfunction (11.4%). Mean duration of TT decreased (58.7-37.8 days, p = 0.02) and patients discharged on TT ≤ 30 days increased (24%-37%, p = 0.019) after intervention. Of surveyed faculty (n = 20), 75.0% reported familiarity with the guidelines and 57.9% reported using them to make therapy decisions.
Conclusions
Following the implementation of a QI initiative, fewer patients were discharged on TT and shorter durations of TT were used. Similar initiatives should be considered at institutions with the prevalent use of TT post-PCI.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Oct 2022; epub ahead of print
Earle W, Abdallah G, Meagher S, Shen K, ... Ho KKL, Secemsky EA
Catheter Cardiovasc Interv: 02 Oct 2022; epub ahead of print | PMID: 36183363
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Impact:
Abstract

Ventricular arrhythmias following transcatheter pulmonary valve replacement with the harmony TPV25 device.

Taylor A, Yang J, Dubin A, Chubb MH, ... McElhinney D, Ceresnak S
Background
Transcatheter pulmonary valve replacement (TPVR) with the Harmony valve (Medtronic, Inc.) was recently approved to treat postoperative native outflow tract pulmonary regurgitation. While the 22 mm Harmony valve Early Feasibility Study demonstrated ventricular tachycardia (VT) in only 5% of patients, little is known about ventricular arrhythmias after TPVR with the larger 25 mm valve (TPV25).
Methods
A single center review was performed of patients with TPV25 implant from 2020 to 2021. Demographic, cardiac, procedural, and postimplant cardiac telemetry data were collected and compared between patients who did and did not have peri-implant ventricular arrhythmia.
Results
Thirty patients underwent TPV25 at a median age of 30 years. On postimplant telemetry, VT events were documented in 12 patients (40%); 11 nonsustained VT (NSVT) (median 3 episodes per patient and 6 beats per episode, maximum 157 episodes) and 1 sustained VT (3%), with Torsades de Pointes secondary to a short coupled premature ventricular contraction (PVC). VT events were associated with annular valve positioning (p < 0.001) and increased postimplant PVC burden (p < 0.0001), but there was no association between VT and other demongraphic, historical, or procedural factors. The frequency of NSVT events fell from 3/h from 0 to 12 h postimplant to 0.5/hr from 12 to 24 h (p < 0.001).
Conclusion
VT occurred commonly (40%) in the first 24 h after TPV25 implant, with self-limited NSVT in 11 of 12 patients and 1 patient with cardiac arrest secondary to Torsades de Pointes. VT only occurred with annular valve positioning. Larger, longer-term studies are needed to determine risk factors for and natural history of post-TPVR VT.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 05 Oct 2022; epub ahead of print
Taylor A, Yang J, Dubin A, Chubb MH, ... McElhinney D, Ceresnak S
Catheter Cardiovasc Interv: 05 Oct 2022; epub ahead of print | PMID: 36198126
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Impact:
Abstract

PERFORMANCE 1 study: Novel carotid stent system with integrated post-dilation balloon and embolic protection device.

Langhoff R, Petrov I, Kedev S, Milosevic Z, ... Cremonesi A, Micari A
Objectives
The PERFORMANCE I study was designed to evaluate the safety and feasibility of the Neuroguard IEP® System, a novel carotid stent system with an integrated embolic filter and post-dilatation balloon, to treat clinically significant carotid artery stenosis.
Background
The risk of major adverse events during carotid artery stenting is comparable to carotid endarterectomy, however, the risk of minor stroke remains higher with stenting.
Methods
In total, 67 patients undergoing carotid artery stenting were enrolled at nine centers in Europe. Follow-up assessments included neurological exams, duplex ultrasound, 12-lead electrocardiogram, and cardiac enzyme analysis. The primary endpoint was the 30-day composite rate of stroke, death, and myocardial infarctions versus a prespecified performance goal. Secondary endpoints included procedure success, device success, and target lesion revascularization.
Results
The study population was predominantly male (74.6%) with a mean age of 69.3 ± 8.9 years and 67% of subjects met at least one criterion placing them at an elevated risk for adverse events following carotid endarterectomy. All patients were treated successfully with the study device. There were no deaths or strokes within 30 days of the index procedure. One subject (1.5%) experienced a non-ST elevation myocardial infarction at day 17. The primary endpoint was met with a 30-day major adverse events rate of 1.5% (1/67). Through 12-month follow-up, there were no strokes, neurological deaths, target lesion revascularizations, or instances of in-stent-restenosis.
Conclusions
Results from this study demonstrate the Neuroguard IEP system is safe and feasible with a stroke/death rate of 0% at 30 days. A large pivotal study is currently underway.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 13 Oct 2022; epub ahead of print
Langhoff R, Petrov I, Kedev S, Milosevic Z, ... Cremonesi A, Micari A
Catheter Cardiovasc Interv: 13 Oct 2022; epub ahead of print | PMID: 36229946
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Impact:
Abstract

Feasibility of facilitated antegrade dissection with Stingray-based re-entry for coronary chronic total occlusions with previously stented graft-to-native-vessel anastomoses.

Parfrey S, Mozid A
Facilitated antegrade dissection re-entry (F-ADR) is a technique described for treating post coronary artery bypass surgery chronic total occlusions (CTO) when there is flush occlusion of the distal cap of the CTO at the vein graft anastomosis. In this scenario retrograde access is usually impossible and if antegrade wiring fails, F-ADR is then the best option. Following antegrade dissection past the anastomosis, a balloon is delivered via the vein graft and inflated in the native vessel distal to the anastomosis to facilitate re-entry using a Stingray catheter. However, the applicability and outcome of this technique have not been described in cases where the graft to native vessel anastomosis has previously been stented. We report a case series of successful CTO recanalization using F-ADR across stented graft-native vessel anastomoses.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 13 Oct 2022; epub ahead of print
Parfrey S, Mozid A
Catheter Cardiovasc Interv: 13 Oct 2022; epub ahead of print | PMID: 36229936
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Impact:
Abstract

The bioresorbable magnesium scaffold (Magmaris)-State of the art: From basic concept to clinical application.

Rola P, Włodarczak S, Doroszko A, Lesiak M, Włodarczak A
Since its introduction to clinical practice, coronary artery stent implantation has become a crucial part of the therapy of coronary artery disease (CAD). Despite the undeniable evolution of percutaneous coronary revascularization procedures, drug-eluting stent (DES) technology shows some limitations. To overcome these limitations bioresorbable vascular scaffolds (BRS) were designed as a vessel-supporting technology allowing for anatomical and functional restoration of the vessel after the scaffold intended resorption. Various materials have been proposed as the basis of the scaffold backbone. In this narrative review, we present second-generation magnesium-alloy bioresorbable scaffold devices (Magmaris; Biotronik). Additionally, we discuss available preclinical and clinical data regarding this new magnesium BRS.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 13 Oct 2022; epub ahead of print
Rola P, Włodarczak S, Doroszko A, Lesiak M, Włodarczak A
Catheter Cardiovasc Interv: 13 Oct 2022; epub ahead of print | PMID: 36229949
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Impact:
Abstract

Outcomes of paclitaxel-coated balloon angioplasty for in-stent calcified nodule: An optical coherence tomography study.

Masuda H, Kuramitsu S, Ito T, Morofuji T, ... Shirai S, Ando K
Background
Paclitaxel-coated balloon (PCB) angioplasty emerges as an effective therapeutic option for in-stent restenosis (ISR). However, whether PCB angioplasty would be effective for in-stent calcified nodule (ISCN) lesions remain fully understood. This study aimed to evaluate the frequency and outcomes of ISCN in patients undergoing PCB angioplasty for ISR after second-generation drug-eluting stents (G2-DES) implantation.
Methods
This study enrolled 179 lesions (160 patients) undergoing PCB angioplasty for G2-DES restenosis with optical coherence tomography guidance. According to the presence of ISCN at the minimum lumen area, the lesions were divided into two groups: the ISCN (n = 16) and the non-ISCN groups (n = 163). The primary study endpoint was the cumulative 3-year incidence of target lesion failure (TLF; a composite of cardiac death, clinically driven target vessel revascularization, and definite stent thrombosis) on a lesion basis.
Results
ISCN was observed in 16 of 179 lesions (8.9%). Cumulative 3-year incidence of TLF was significantly higher in the ISCN group than in the non-CN group (85.3% vs. 16.9%, inverse probability weighted hazard ratio [HR] 4.46, 95% confidence intervals [CIs]: 2.42-8.22, p < 0.001). Risk factors associated with TLF were ISCN (HR 4.55, 95% CI: 1.56-13.3, p = 0.005), recurrent ISR (HR 2.82, 95% CI: 1.50-3.30, p = 0.001), and early ISR (HR 2.18, 95% CI: 1.21-3.92, p = 0.009).
Conclusion
ISCN was observed in 8.3% of G2-DES restenosis. PCB angioplasty had little effect on ISCN lesions compared with non-ISCN lesions, suggesting the need for careful clinical follow-up of patients with ISCN lesions after PCB angioplasty.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 13 Oct 2022; epub ahead of print
Masuda H, Kuramitsu S, Ito T, Morofuji T, ... Shirai S, Ando K
Catheter Cardiovasc Interv: 13 Oct 2022; epub ahead of print | PMID: 36229982
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Impact:
Abstract

Lithotripsy for calcified in-stent restenosis.The \"rock strata peeling pattern\": A novel fracture pattern detected by optical coherence tomography.

Del Val D, Cuesta J, Roquero P, Alfonso F
Calcified neoatherosclerosis represents a particularly challenging scenario in patients with in-stent restenosis (ISR), frequently associated with worse angiographic and optical coherence tomography (OCT) results compared with other patients with typical ISR. Intravascular lithotripsy (IVL) has emerged as a safe and effective technology to circumferentially modify calcium in heavily calcified coronary lesions. Preliminary data also suggest its usefulness in calcified neoatheroscerosis. This case report aims to describe a novel fracture pattern after IVL identified by OCT (the \"rock strata peeling pattern\") in patients presenting with ISR due to calcified neoatherosclerosis.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 13 Oct 2022; epub ahead of print
Del Val D, Cuesta J, Roquero P, Alfonso F
Catheter Cardiovasc Interv: 13 Oct 2022; epub ahead of print | PMID: 36229940
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Impact:
Abstract

Single-access for Impella-supported percutaneous coronary intervention using a sheathless technique with an 8 Fr guide.

Verreault-Julien L, Shekiladze N, Wollmuth J, Rinfret S
Complex and higher-risk indicated percutaneous coronary interventions at times require mechanical circulatory support, most often with Impella devices. The use of such devices traditionally required additional arterial access site(s), increasing risk of vascular complications. The Single-access for Hi-risk percutaneous coronary intervention (SHiP) technique was described to overcome this issue but was limited to the use of 7F guides. Larger 8F guides often provide incremental support and space compared to 7F guides, sometimes needed in complex procedures. We described a modified SHiP technique using an 8 Fr guide delivered sheathless using Rotaglide.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 13 Oct 2022; epub ahead of print
Verreault-Julien L, Shekiladze N, Wollmuth J, Rinfret S
Catheter Cardiovasc Interv: 13 Oct 2022; epub ahead of print | PMID: 36229978
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Impact:
Abstract

Optical coherence tomography versus angiography and intravascular ultrasound to guide coronary stent implantation: A systematic review and meta-analysis.

Siddiqi TJ, Khan MS, Karimi Galougahi K, Shlofmitz E, ... Jeremias A, Ali ZA
Background
Optical coherence tomography (OCT) is an adjunct to angiography-guided coronary stent placement. However, in the absence of dedicated, appropriately powered randomized controlled trials, the impact of OCT on clinical outcomes is unclear.
Objective
To conduct a systematic review and meta-analysis of all available studies comparing OCT-guided versus angiography-guided and intravascular ultrasound (IVUS)-guided coronary stent implantation.
Methods
MEDLINE and Cochrane Central were queried from their inception through July 2022 for all studies that sought to compare OCT-guided percutaneous coronary intervention (PCI) to angiography-guided and IVUS-guided PCI. The primary endpoint was minimal stent area (MSA) compared between modalities. Clinical endpoints of interest were all-cause and cardiovascular mortality, major adverse cardiovascular events (MACE), myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis (ST). Risk ratios (RRs) and mean differences (MDs) with their corresponding 95% confidence intervals (CIs) were pooled using a random-effects model.
Results
Thirteen studies (8 randomized control trials and 5 observational studies) enrolling 6312 participants were included. OCT was associated with a strong trend toward increased MSA compared to angiography (MD = 0.36, p = 0.06). OCT-guided PCI was also associated with a reduction in the incidence of all-cause mortality [RR = 0.59, 95% CI (0.35, 0.97), p = 0.04] and cardiovascular mortality [RR = 0.41, 95% CI (0.21, 0.80), p = 0.009] compared with angiography-guided PCI. Point estimates favored OCT relative to angiography in MACE [RR = 0.75, 95% CI (0.47, 1.20), p = 0.22] and MI [RR = 0.75, 95% CI (0.53, 1.07), p = 0.12]. No differences were detected in ST [RR = 0.71, 95% CI (0.21, 2.44), p = 0.58], TLR [RR = 0.71, 95% CI (0.17, 3.05), p = 0.65], or TVR rates [RR = 0.89, 95% CI (0.46, 1.73), p = 0.73]. Compared with IVUS guidance, OCT guidance was associated with a nonsignificant reduction in the MSA (MD = -0.16, p = 0.27). The rates of all-cause and cardiovascular mortality, MACE, MI, TLR, TVR, or ST were similar between OCT-guided and IVUS-guided PCI.
Conclusions
OCT-guided PCI was associated with reduced all-cause and cardiovascular mortality compared to angiography-guided PCI. These results should be considered hypothesis generating as the mechanisms for the improved outcomes were unclear as no differences were detected in the rates of TLR, TVR, or ST. OCT- and IVUS-guided PCI resulted in similar post-PCI outcomes.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 17 Oct 2022; epub ahead of print
Siddiqi TJ, Khan MS, Karimi Galougahi K, Shlofmitz E, ... Jeremias A, Ali ZA
Catheter Cardiovasc Interv: 17 Oct 2022; epub ahead of print | PMID: 36251325
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Impact:
Abstract

Impact of intracoronary assessments on revascularization decisions: A contemporary evaluation.

Gillmore T, Jung RG, Moreland R, Di Santo P, ... Labinaz M, Hibbert B
Objectives
To investigate the real-world implementation of intracoronary assessment (ICA) techniques and evaluate their impact on clinical decisions regarding the management of coronary artery disease (CAD) in contemporary practice.
Background
Coronary angiogram is the gold standard used to diagnose vessel stenosis and guide percutaneous coronary intervention (PCI); however, it is limited by its two-dimensional imaging capabilities. ICA techniques like intravascular ultrasound and optical coherence tomography capture the vessel in three-dimensional images. Comparatively, fractional flow reserve provides information on the physiologic significance of coronary stenosis. Both techniques may improve PCI outcomes if they routinely change physician behavior.
Methods
Patients who underwent ICA between August 2015 and March 2020 were included in the study. The primary outcome was the clinical impact of ICA on physician clinical decision making of a stenotic vessel. The secondary outcome was the clinical changes that occurred following ICA.
Results
A total of 1135 patients were included in the study. Physiologic assessment (PA) and image assessment (IA) were performed in 61.4% and 38.6% respectively. Management plans were changed in 38.1% and 23.9% of patients who received PA and IA. Over half of the management change resulted in physicians deciding to not intervene on the stenotic vessel. One-year outcome of these decisions showed no significant increase in major adverse cardiac events (hazard ratio [HR], 0.68; 95% confidence interval [CI], 0.40-1.15; p = 0.15) or unplanned revascularization (HR, 0.78; 95% CI, 0.35-1.74; p = 0.55) suggesting reliance on PA/IA data did not increase risk.
Conclusion
Selected ICA alters physician management of CAD in one-third of patients being evaluated for revascularization-typically leading to fewer interventions. All cause death is numerally lower in patients that received a change in management. However, the 1-year outcome of these altered decisions does not appear to be significantly different.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 19 Oct 2022; epub ahead of print
Gillmore T, Jung RG, Moreland R, Di Santo P, ... Labinaz M, Hibbert B
Catheter Cardiovasc Interv: 19 Oct 2022; epub ahead of print | PMID: 36259740
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Impact:
Abstract

Non-surgical extirpation of a non-infectious expanding tricuspid valve mass by percutaneous aspiration thrombectomy.

Asllanaj B, Urzua A, Dota A, Levisman J
Marantic endocarditis refers to a noninfectious lesion, usually in the aortic and mitral valves, that is most commonly seen in advanced malignancy and systemic lupus erythematosus. Inflammatory conditions, including antiphospholipid syndrome (APS), are a rare etiology making up less than 20% of reported cases. The condition is thought to be due to a hypercoagulable state and found postmortem with rates in autopsy series ranging from 0.9% to 1.6%. In comparison to infective endocarditis, marantic endocarditis has a greater tendency for valve vegetations to embolize. Common treatment modalities include anticoagulation or valve replacement. Although percutaneous aspiration thrombectomy of right-sided heart chamber thrombi exists, there are limited reports demonstrating its use with regards to treatment of right-sided endocarditis. We present the case of an older male with a history of Factor V Leiden and APS who was admitted due to a rapidly expanding mass on the tricuspid valve (TV). Despite serial blood cultures being negative, the patient received adequate antibiotic therapy for more than 4 weeks. Transthoracic echocardiogram showed an enlarged TV vegetation with an increased diameter from 10 to 30 mm over 6 weeks. Due to the patient\'s high operative risk and concern for embolization complications, a multidisciplinary decision was made to perform percutaneous aspiration thrombectomy of the TV vegetation. Subsequent biopsy of the lesion confirmed it was noninfectious and nonmalignant. Thus, the patient was started on systemic anticoagulation for prevention of thromboembolic events.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 18 Oct 2022; epub ahead of print
Asllanaj B, Urzua A, Dota A, Levisman J
Catheter Cardiovasc Interv: 18 Oct 2022; epub ahead of print | PMID: 36255148
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Impact:
Abstract

Long-term outcomes of intermediate coronary stenosis in patients undergoing hemodialysis after deferred revascularization based on fractional flow reserve.

Nagasaka T, Amanai S, Ishibashi Y, Aihara K, ... Koitabashi N, Ishii H
Objectives
This study aimed to assess the long-term outcomes of patients undergoing hemodialysis (HD) after deferred revascularization based on fractional flow reserve (FFR).
Background
FFR is a practical technique for assessing the functional severity of intermediate coronary stenosis. Prior research has revealed a satisfactory outcome in patients after the deferral of percutaneous coronary intervention for coronary lesions based on FFR measurement. However, little research has been conducted focusing on patients undergoing HD.
Methods
The retrospective study comprised 225 consecutive patients with FFR assessment and deferred revascularization between January 2016 and December 2019. Based on a deferral cutoff FFR value of >0.80, we assessed the differences in all-cause death, major adverse cardiac events (MACEs), and target vessel failure (TVF) between the HD (n = 69) and non-HD groups (n = 156) during a mean ± standard deviation routine follow-up of 32.2 ± 13.4 months.
Results
Although the HD group had significantly higher rates of diabetes mellitus than the non-HD group (53.6% vs. 37.2%, p = 0.021), there were no significant differences in sex, left ventricular ejection fraction, or other risk factors between the groups, nor with respect to stenosis diameter or mean FFR. The HD group had a significantly higher incidence of TVF than the non-HD group (34.8% vs. 14.1%, p < 0.001), as well as a significantly higher risk of all-cause death and MACEs.
Conclusions
The study revealed that deferred revascularization in coronary lesions with an FFR value of >0.80 in patients undergoing HD was associated with poor outcomes. Therefore, it is important to carefully monitor patients with intermediate coronary stenosis undergoing HD.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 19 Oct 2022; epub ahead of print
Nagasaka T, Amanai S, Ishibashi Y, Aihara K, ... Koitabashi N, Ishii H
Catheter Cardiovasc Interv: 19 Oct 2022; epub ahead of print | PMID: 36262079
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Impact:
Abstract

Additional balloon aortic valvuloplasty to overcome the difficult removal of a self-expandable transcatheter aortic valve system due to valve infolding.

Yashige M, Zen K, Takamatsu K, Matoba S
Transcatheter aortic valve replacement (TAVR) is a well-established treatment for severe aortic stenosis. Advances in the devices used and operators\' technique have reduced the frequency of complications. However, valve infolding is a rare but serious outcome after the implantation of self-expanding prostheses. We report a case of a successful bailout of a device that was difficult to remove because of valve infolding. TAVR using a 26 mm Evolut PRO+ system (Medtronic) was planned for a 91-year-old woman with severe aortic stenosis. After the valve was deployed in a satisfactory position on the second release, the system could not be removed because the nose cone was hooked to the basal frame of the deployed valve. To overcome this situation, an additional balloon was inserted from the contralateral femoral side and inflated, and we extracted the system successfully by pulling out the device while simultaneously deflating the balloon. Postoperative computed tomography revealed valve infolding, which was considered to cause the difficulty in system removal. Infoldings of self-expandable prostheses should be considered when faced with difficulty in removing the catheter system, and the method elucidated in this case report can be effective to manage it.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 19 Oct 2022; epub ahead of print
Yashige M, Zen K, Takamatsu K, Matoba S
Catheter Cardiovasc Interv: 19 Oct 2022; epub ahead of print | PMID: 36259731
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Impact:
Abstract

Cognitive function in late-stage HFpEF patients with tricuspid regurgitation undergoing transcatheter tricuspid valve intervention.

Gerçek M, Irimie AA, Gerçek M, Fox H, ... Rudolph V, Friedrichs KP
Objectives
This study evaluates the impact of transcatheter tricuspid valve interventions (TTVI) on cognitive function (CF), quality of life (QOL), and exercise capacity in late-stage heart failure with preserved ejection fraction (HFpEF) and relevant tricuspid regurgitation (TR).
Background
Reduced cardiac output (CO) critically affects CF. Severe TR aggravates CO reduction in HFpEF, while TTVI has been demonstrated to re-establish CO to a significant extent. The effect of TTVI on CF of HFpEF patients has so far not been investigated.
Methods
Assessment of CF was performed using the standardized Montreal Cognitive Assessment test in 34 symptomatic HFpEF patients with at least severe TR before and 3 months after TTVI alongside echocardiographic examinations and assessment of exercise capacity and QOL.
Results
Median age of the patients was 81.0 [78.8; 83.0] years and 50.0% were female. CF was impaired in 67.6% of the patients. TR ≤ moderate was achieved in 94.1% of the cases. Overall CF improved significantly (from 20.6 ± 3.9 to 23.0 ± 4.4; p = 0.001). Particularly, significant improvements were identified in the executive function (p < 0.001) and memory (p = 0.008). In addition, linear regression analysis demonstrated a significant collinearity of improvement between executive function as well as memory and increased CO (ρ = 0.695; p < 0.001 and ρ = 0.628; p < 0.001, respectively). The walked distance and QOL also improved significantly 3 months after TTVI.
Conclusion
Cognitive impairment is highly prevalent in HFpEF patients with severe TR. TTVI results in an improved CF, especially with regard to executive function and memory. These improvements also correlate with more efficient hemodynamics reflected by increased CO.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 19 Oct 2022; epub ahead of print
Gerçek M, Irimie AA, Gerçek M, Fox H, ... Rudolph V, Friedrichs KP
Catheter Cardiovasc Interv: 19 Oct 2022; epub ahead of print | PMID: 36259741
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Impact:
Abstract

Combined rotational atherectomy and cutting balloon angioplasty prior to drug-eluting stent implantation in severely calcified coronary lesions: The PREPARE-CALC-COMBO study.

Allali A, Toelg R, Abdel-Wahab M, Hemetsberger R, ... Geist V, Richardt G
Objectives
To evaluate the safety and efficacy of lesion preparation using rotational atherectomy (RA) with consecutive cutting balloon angioplasty (Rota-Cut).
Background
Whether the Rota-Cut combination improves stent performance in severely calcified coronary lesions is unknown.
Methods
PREPARE-CALC-COMBO is a single-arm prospective trial in which 110 patients were treated with a Rota-Cut strategy before implantation of sirolimus-eluting stents and compared with patients treated with modified balloon (MB, scoring or cutting) or RA from a historical cohort (the randomized PREPARE-CALC trial). The study had two primary endpoints: in-stent acute lumen gain (ALG) by quantitative angiographic analysis and stent expansion (SE) on optical coherence tomography.
Results
In-stent ALG was significantly higher with Rota-Cut compared to RA or MB alone (1.92 ± 0.45 mm vs. 1.74 ± 0.45 mm with MB vs. 1.70 ± 0.42 mm with RA; p = 0.001 and p < 0.001, respectively). SE was comparable between groups (75.1 ± 13.8% vs. 73.5 ± 13.3 with MB vs. 73.1 ± 12.2 with RA; p = 0.19 and p = 0.39, respectively). The Rota-Cut combination resulted in higher minimal stent area (MSA) (7.1 ± 2.2mm2 vs. 6.1 ± 1.7mm2  with MB vs. 6.2 ± 1.9mm2 with RA; p = 0.003 and p = 0.004, respectively). In-hospital death occurred in one patient. Target vessel failure at 9 months was low and comparable between groups (8.2% vs. 8% with MB vs. 6% with RA; p = 1 and p = 0.79, respectively).
Conclusion
Rota-Cut combination resulted in higher ALG and larger MSA compared with historical control of RA or MB alone, but was not associated with higher SE. Despite extensive lesion preparation, this strategy is safe, feasible, and associated with favorable clinical outcome at 9 months.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 19 Oct 2022; epub ahead of print
Allali A, Toelg R, Abdel-Wahab M, Hemetsberger R, ... Geist V, Richardt G
Catheter Cardiovasc Interv: 19 Oct 2022; epub ahead of print | PMID: 36262074
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Impact:
Abstract

Age-related changes in the coronary microcirculation influencing the diagnostic performance of invasive pressure-based indices and long-term patient prognosis.

Faria D, Mejia-Renteria H, Lee JM, Lee SH, ... Koo BK, Escaned J
Objectives
Investigate age-related changes in coronary microvascular function, its effect on hyperemic and non-hyperemic indices of stenosis relevance, and its prognostic implications.
Background
Evidence assessing the effect of age on fractional flow reserve (FFR), resting mean distal intracoronary pressure/mean aortic pressure (Pd/Pa), and microcirculatory function remains scarce.
Methods
This is a post hoc study of a large prospective international registry (NCT03690713) including 1134 patients (1326 vessels) with coronary stenoses interrogated with pressure and flow guidewires. Age-dependent correlations with functional indices were analyzed. Prevalences of FFR, resting Pd/Pa, and coronary flow reserve (CFR) classification agreement were assessed. At 5 years follow-up, the relation between resting Pd/Pa, CFR, and their age-dependent implications on FFR-guided percutaneous coronary intervention (PCI) deferral (deferred if FFR > 0.80) were investigated using vessel-oriented composite outcomes (VOCO) composed of death, myocardial infarction, and repeated revascularization.
Results
Age correlated positively with FFR (r = 0.08, 95% confidence interval [CI]: 0.03 to 0.13, p =  0.005), but not with resting Pd/Pa (r = -0.03, 95% CI:-0.09 to 0.02, p = 0.242). CFR correlated negatively with age (r = -0.15, 95% CI: -0.21 to -0.10, p < 0.001) due to a significant decrease in maximal hyperemic flow in older patients. Patients over 60 years of age with FFR-guided deferred-PCI abnormal resting Pd/Pa or abnormal CFR had increased risk of VOCO (hazard ratio [HR]: 2.10, 95% CI: 1.15 to 4.36, p = 0.048; HR: 2.46, 95% CI:1.23 to 4.96, p = 0.011; respectively).
Conlusions
Aging is associated with decrease in microcirculatory vasodilation, as assessed with adenosine-based methods like CFR. In patients older than 60 years in whom PCI is deferred according to FFR > 0.80, CFR and resting Pd/Pa have an incremental value in predicting future vessel-oriented patient outcomes.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 23 Oct 2022; epub ahead of print
Faria D, Mejia-Renteria H, Lee JM, Lee SH, ... Koo BK, Escaned J
Catheter Cardiovasc Interv: 23 Oct 2022; epub ahead of print | PMID: 36273417
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Impact:
Abstract

Transcatheter aortic valve with a novel self-expandable device in patients with previous mechanical mitral valve prosthesis.

Tébar Márquez D, Moreno R, Galeote G, Jurado-Roman A, ... Moreno-Gómez I, Lopez de Sa E
Objectives
The aim of this study was to describe the procedural and early outcomes of patients with mechanical mitral valve prosthesis (MVP) undergoing transcatheter aortic valve replacement (TAVR) with a novel self-expandable retrievable device.
Background
TAVR in patients with prior MVP may have an increased risk of complications related to device positioning and interference between both prosthetic valves.
Methods
An observational study was conducted, including eight patients with severe symptomatic aortic stenosis and prior mechanical MVP who underwent TAVR with the novel device AllegraTM (Biosensors). No transesophageal monitoring was used.
Results
The mean age of the study population was 75 years. The mean distance between MVP and aortic annulus was 3.8 mm. Procedural success was achieved in all patients with no major intraprocedural, in-hospital, or follow-up complications.
Conclusions
TAVR with Allegra TAVI system in patients with prior MVP offers good procedural and clinical outcomes.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 23 Oct 2022; epub ahead of print
Tébar Márquez D, Moreno R, Galeote G, Jurado-Roman A, ... Moreno-Gómez I, Lopez de Sa E
Catheter Cardiovasc Interv: 23 Oct 2022; epub ahead of print | PMID: 36273418
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Impact:
Abstract

Intravascular imaging for left main stem assessment: An update on the most recent clinical data.

Cortese B, Piraino D, Gentile D, Onea HL, Lazar L
Left main (LM) stem has different structural and anatomical characteristics compared to all of the other segments of the coronary tree, thus its management through percutaneous coronary intervention (PCI) is a challenge and is associated with worse clinical outcome and higher need for revascularization as compared to other lesion settings. Intravascular imaging, by means of intravascular ultrasound (IVUS) or optical coherence tomography (OCT), is an important tool for LM PCI guidance, aiming at improving the immediate performance and the long term outcome of this procedure. Following current guidelines and recent scientific findings, IVUS becomes important to firstly assess, and finally evaluate the result of LM stenting, according to the experience and preferences of the operator. The role of OCT still remains to be defined, but recent data is shedding light also on this imaging technique. The aim of this review is to highlight the latest scientific advancements regarding intravascular imaging in LM coronary artery disease.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 23 Oct 2022; epub ahead of print
Cortese B, Piraino D, Gentile D, Onea HL, Lazar L
Catheter Cardiovasc Interv: 23 Oct 2022; epub ahead of print | PMID: 36273435
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Impact:
Abstract

Revascularization and long-term outcomes in high-acuity spontaneous coronary artery dissection.

Thaler C, Witt DR, Henry TD, Grey EZ, ... Schmidt CW, Sharkey SW
Background
Spontaneous coronary artery dissection (SCAD) is often treated conservatively due to revascularization risks. Yet, an important number of SCAD patients have high acuity characteristics necessitating revascularization, with uncertain long-term outcomes.
Objectives
Document revascularization utilization and long-term outcomes in high acuity SCAD.
Methods
Prospective/retrospective analysis of consecutive patients with acute myocardial infarction (AMI) due to first SCAD event presenting directly to the Minneapolis Heart Institute 2002-2021, median follow-up 3.8 years.
Results
Among 139 patients (age 49 ± 12 years, 96% female), revascularization was performed in 60 (43%), utilizing percutaneous coronary intervention (PCI) (n = 56, successful in 80%) or coronary artery bypass graft (n = 4). In the entire cohort, 90 (65%) unique patients had one or more high acuity characteristic: ST-elevation (38%), proximal dissection (38%), cardiogenic shock (6.5%), cardiac arrest (9.4%), left main dissection (6.5%), peripartum dissection (7.2%). High acuity patients accounted for 51 of 60 (85%) revascularizations. Revascularization rates were: ST-elevation (60%), proximal dissection (62%), cardiogenic shock (89%), cardiac arrest (62%), left main dissection (100%), peripartum dissection (70%). Survival was 97% (revascularized) vs 100% (nonrevascularized); p = 0.2. Adverse outcomes (revascularized vs. nonrevascularized) included recurrent AMI:16.7% versus 8.9%; p = 0.2, SCAD recurrence: 13.3% versus 6.3%; p = 0.1, stroke: 5% versus 2.5%; p = 0.44, implantable cardioverter-defibrillator: 6.7% versus 6.3%; p > 0.9. Reintervention was necessary in 21% of PCI-treated patients.
Conclusions
High-acuity characteristics were present in nearly two-thirds of this SCAD cohort; the vast majority of revascularizations were performed in high-acuity patients. Despite high acuity, long-term survival was favorable in revascularized patients.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 23 Oct 2022; epub ahead of print
Thaler C, Witt DR, Henry TD, Grey EZ, ... Schmidt CW, Sharkey SW
Catheter Cardiovasc Interv: 23 Oct 2022; epub ahead of print | PMID: 36273416
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Impact:
Abstract

Use of the PK Papyrus covered coronary stent in the treatment of Kawasaki disease-associated giant coronary artery aneurysms.

Naimi I, Morray B, Portman MA, Steinberg ZL
Kawasaki disease (KD) is an acute vasculitis that can cause coronary artery inflammation and aneurysm formation leading to early obstructive disease. We describe the use of PK Papyrus covered stents (Biotronic, Inc.) in three pediatric patients to exclude coronary artery aneurysms (CAA) from the circulation and relieve aneurysm associated stenoses. Follow-up angiography at 11-17 months postprocedure demonstrated persistent exclusion of CAA and varying degrees of in-stent restenosis (ISR). Two patients required percutaneous coronary intervention with drug eluting stent (DES) implantation to relieve in-stent stenosis. Our findings suggest that CAA exclusion with the PK Papyrus stent is possible and may be a valuable tool in simultaneously treating stenotic and thrombogenic CAA in pediatric KD patients. ISR of these non-DES remains an issue and may require additional interventions within the short-term to maintain vessel patency.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 26 Oct 2022; epub ahead of print
Naimi I, Morray B, Portman MA, Steinberg ZL
Catheter Cardiovasc Interv: 26 Oct 2022; epub ahead of print | PMID: 36285531
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Impact:
Abstract

Evaluation of factors associated with selection for coronary angiography and in-hospital mortality among patients presenting with out-of-hospital cardiac arrest without ST-segment elevation.

Zheng WC, Noaman S, Batchelor RJ, Hanson L, ... Cox N, Chan W
Background
Clinical factors favouring coronary angiography (CA) selection and variables associated with in-hospital mortality among patients presenting with out-of-hospital cardiac arrest (OHCA) without ST-segment elevation (STE) remain unclear.
Methods
We evaluated clinical characteristics associated with CA selection and in-hospital mortality in patients with OHCA, shockable rhythm and no STE.
Results
Between 2014 and 2018, 118 patients with OHCA and shockable rhythm without STE (mean age 59; males 75%) were stratified by whether CA was performed. Of 86 (73%) patients undergoing CA, 30 (35%) received percutaneous coronary intervention (PCI). CA patients had shorter return of spontaneous circulation (ROSC) time (17 vs. 25 min) and were more frequently between 50 and 60 years (29% vs. 6.5%), with initial Glasgow Coma Scale (GCS) score >8 (24% vs. 6%) (all p < 0.05). In-hospital mortality was 33% (n = 39) for overall cohort (CA 27% vs. no-CA 50%, p = 0.02). Compared to late CA, early CA ( ≤ 2 h) was not associated with lower in-hospital mortality (32% vs. 34%, p = 0.82). Predictors of in-hospital mortality included longer defibrillation time (odds ratio 3.07, 95% confidence interval 1.44-6.53 per 5-min increase), lower pH (2.02, 1.33-3.09 per 0.1 decrease), hypoalbuminemia (2.02, 1.03-3.95 per 5 g/L decrease), and baseline renal dysfunction (1.33, 1.02-1.72 per 10 ml/min/1.73 m2 decrease), while PCI to lesion (0.11, 0.01-0.79) and bystander defibrillation (0.06, 0.004-0.80) were protective factors (all p < 0.05).
Conclusions
Among patients with OHCA and shockable rhythm without STE, younger age, shorter time to ROSC and GCS >8 were associated with CA selection, while less effective resuscitation, greater burden of comorbidities and absence of treatable coronary lesion were key adverse prognostic predictors.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 23 Oct 2022; epub ahead of print
Zheng WC, Noaman S, Batchelor RJ, Hanson L, ... Cox N, Chan W
Catheter Cardiovasc Interv: 23 Oct 2022; epub ahead of print | PMID: 36273421
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Impact:
Abstract

Gender differences in chronic total occlusion percutaneous coronary interventions: Insights from the PROGRESS-CTO registry.

Kostantinis S, Simsek B, Karacsonyi J, Alaswad K, ... Brilakis ES, Prasad M
Background
There are limited data describing gender differences in patients undergoing chronic total occlusion (CTO) percutaneous coronary interventions (PCI).
Methods
We compared baseline clinical and angiographic characteristics and procedural outcomes between men and women among 9457 CTO PCIs performed at 38 centers between 2012 and 2022.
Results
A total of 7687 (81%) men and 1770 (19%) women were treated. Women were older, more likely to have comorbidities such as diabetes, hypertension and peripheral arterial disease, and had higher left ventricular ejection fraction. The most common CTO target vessel was the right coronary artery for both men (53%) and women (52%), although the left anterior descending artery was more frequently the target vessel among women (31% vs. 25%; p < 0.001). The J-CTO score (2.4 ± 1.3 vs. 2.2 ± 1.2; p < 0.001) as well as the PROGRESS-CTO score (1.3 ± 1.0 vs. 1.1 ± 1.0; p < 0.001) were higher among men. In female patients, antegrade wiring was more frequently the initial crossing strategy (87.6% vs. 82.4%; p < 0.001) and was more successful in crossing the target lesion (62.7% vs. 54.0%; p < 0.001) compared with men. Interventions in men required longer procedure time and fluoroscopy time, as well as higher air kerma radiation dose and contrast volume when compared to women. Technical (89% vs. 86%; p < 0.001) and procedural (87% vs. 84%; p = 0.003) success rates were higher among women. In-hospital major adverse cardiovascular events (MACE) were also higher in women (2.9% vs. 1.8%; p < 0.001).
Conclusions
Women undergoing CTO PCI had higher technical and procedural success rates, but also higher in-hospital MACE compared with men.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 25 Oct 2022; epub ahead of print
Kostantinis S, Simsek B, Karacsonyi J, Alaswad K, ... Brilakis ES, Prasad M
Catheter Cardiovasc Interv: 25 Oct 2022; epub ahead of print | PMID: 36284458
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Impact:
Abstract

Impact of intravascular ultrasound-incomplete stent apposition on stent failure.

Watanabe Y, Sakakura K, Taniguchi Y, Yamamoto K, ... Wada H, Fujita H
Objectives
This study aimed to investigate the relationship between immediate incomplete stent apposition (ISA) detected by intravascular ultrasound (IVUS) and midterm stent failure.
Background
Stent failure is one of serious clinical events related to percutaneous coronary intervention (PCI). The previous studies using optical coherence tomography showed that ISA could be associated with stent thrombosis. However, the association between immediate ISA detected by IVUS and stent failure has not been fully investigated.
Methods
We included 396 lesions that underwent elective PCI, and divided those into the appropriate stent apposition (ASA) group (n = 290) and the ISA group (n = 106). The primary endpoint was stent failure, which was defined as a composite of ischemia-driven target lesion revascularization and stent thrombosis. We compared clinical and lesion characteristics between the two groups, and performed a multivariate COX hazard analysis to investigate the association between immediate ISA and stent failure.
Results
The median follow-up duration was 1296 days. The Kaplan-Meier curves revealed the higher incidence of stent failure in the ISA group than in the ASA group (p < 0.001). The multivariate stepwise COX hazard analysis showed that immediate ISA (hazard ratio 4.97, 95% confidence interval 1.31-18.82, p = 0.018) was significantly associated with stent failure. When we set the cut-off value of the immediate ISA distance as 0.25 mm, the distance ≥ 0.25 mm had 68.8% sensitivity and 85.0% specificity to predict stent failure.
Conclusions
Immediate ISA detected by IVUS was associated with midterm stent failure. We should pay attention to reduce immediate ISA for improving the midterm outcomes.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 27 Oct 2022; epub ahead of print
Watanabe Y, Sakakura K, Taniguchi Y, Yamamoto K, ... Wada H, Fujita H
Catheter Cardiovasc Interv: 27 Oct 2022; epub ahead of print | PMID: 36300639
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Impact:
Abstract

Predictors of successful same-day discharge and 1-year outcomes after left atrial appendage closure.

Waas S, Galo J, Yoon SH, Dallan LAP, ... Arruda M, Filby SJ
Background
Same-day discharge (SDD) following left atrial appendage closure (LAAC) is increasingly common but predictors of successful SDD and 1-year clinical outcomes have not been described.
Objective
The purpose of this study was to explore predictors of successful SDD and report 1-year outcomes in patients undergoing LAAC with SDD.
Methods
A prospective analysis was performed over a 20-month period of 225 consecutive patients that underwent LAAC in a large, academic hospital. All patients included in the study underwent a SDD protocol. Baseline characteristics and 1-year outcomes of patients discharged same day of the procedure versus those that required at least one overnight stay were compared. Adverse events, procedural success, and procedure times were evaluated.
Results
One hundred and sixty-one patients (72%) of patients were discharged the same day and 64 patients (28%) required at least an overnight stay (non-SDD: NSDD). NSDD patients were older and more often female. Procedure time was also longer in the NSDD group than in the SDD (63.4 vs. 55.1 min; p = 0.01). While overall procedural success rates were similar between the SDD and NSDD groups (99.4% vs. 98.4%; p = 0.39), NSDD patients had more complications (9.4% vs. 0%; p = 0.01) and higher number of devices per procedure (1.2 vs. 1.0; p = 0.01) as compared to SDD. At 1 year, there were no significant difference between the SDD and NSDD groups in stroke (1.1% vs. 0%; log-rank p = 0.44) and all-cause mortality (3.9% vs. 4.7%; log-rank p = 0.70).
Conclusion
In this single-center LAAC experience, female sex, older age, and longer procedure duration were associated with higher likelihood for need of overnight stay. At 1-year follow-up, there were no significant differences in stroke events and death rates between SDD and NSDD groups.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Oct 2022; epub ahead of print
Waas S, Galo J, Yoon SH, Dallan LAP, ... Arruda M, Filby SJ
Catheter Cardiovasc Interv: 31 Oct 2022; epub ahead of print | PMID: 36316818
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Impact:
Abstract

Feasibility of transcaval access TAVI in morbidly obese patients: A single-center experience.

Michail M, Cockburn J, Tanseco KVP, Arunothayaraj S, ... Trivedi U, Hildick-Smith D
Objectives
We report a single-center experience in utilizing the transcaval-access transcatheter aortic valve implantation (TAVI) as an alternative approach in morbidly obese patients.
Background
Morbidly obese patients present frequently for TAVI. Transfemoral arterial access TAVI in these patients is technically challenging due to deep arterial access, resulting in a higher risk of vascular complications. Transcaval access TAVI is increasingly used in patients with prohibitive iliofemoral arterial access.
Methods
We used the transcaval approach for eight morbidly obese patients who had otherwise technically feasible femoral arterial access. This technique provides an alternative arterial access point that potentially circumvents some of the challenges relating to femoral arterial access.
Results
We report eight morbidly obese patients with a mean body mass index of 42.3 ± 6.2 kg/m2 who underwent transcaval access TAVI at our center (mean EuroScore II 2.47 ± 1.83%). The patient mean age was 70.3 ± 9.8 years; six were female. All eight patients underwent a successful and uncomplicated procedure. The median time to discharge was 2 days and all patients were alive at 30 days.
Conclusions
Transcaval access TAVI is a feasible alternative for morbidly obese patients and may reduce vascular complications. Further data are required to evaluate the safety of this approach.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print
Michail M, Cockburn J, Tanseco KVP, Arunothayaraj S, ... Trivedi U, Hildick-Smith D
Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print | PMID: 36321613
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Impact:
Abstract

Coronary angiography of the ex-situ beating donor heart in a portable organ care system.

Meredith T, Scheuer S, Hoffman M, Joshi Y, ... Macdonald P, Muller D
Objectives
To determine safety and feasibility of ex-situ coronary angiography.
Background
To cater for the perpetually growing demand for heart donors, interest in donation following circulatory death (DCD) has been rekindled. Further pursuit of donor pool expansion has led to eligibility extension to \"marginal\" donors who are at higher risk of coronary artery disease (CAD). Excluding CAD in potentially eligible DCD donors, for whom ante-mortem angiography is commonly not permitted, is therefore challenging. Ex-situ coronary angiography serves as an ethical and feasible diagnostic tool to assess for preclusive CAD.
Methods
We undertook a systematic review of the published literature and institutional retrospective review of case experience with ex-situ coronary angiography of donor hearts, supported by a portable organ care system.
Results
Combined literature and institutional case review yielded nine total cases of ex-situ coronary angiography of donor human hearts plus one experimental porcine model. Of the eight cases of ex-situ coronary angiography performed at our institute, all were conducted without complication or injury to the allograft. Two thirds of reported human cases have proceeded to successful transplantation.
Conclusions
Diagnostic coronary angiography of the ex-situ beating donor heart is safe, feasible, and demonstrates novel clinical utility in mitigating subsequent transplantation of unsuitable allografts. In the setting of suspected coronary atherosclerosis of the donor heart, which may preclude favorable transplantation outcomes, ex-situ coronary angiography should be considered at eligible transplant centers.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print
Meredith T, Scheuer S, Hoffman M, Joshi Y, ... Macdonald P, Muller D
Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print | PMID: 36321629
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Impact:
Abstract

Acute myocardial infarction caused by Kawasaki disease requires more intensive therapy: Insights from the Japanese registry of All Cardiac and Vascular Diseases-Diagnosis Procedure combination.

Anzai F, Yoshihisa A, Takeishi R, Hotsuki Y, ... Misaka T, Takeishi Y
Background
Kawasaki disease (KD) induces coronary arteritis, which causes subsequent coronary aneurysms, and contributes to acute myocardial infarction (AMI). However, the differences regarding real-world treatment selection and mortality between AMI-complicated KD and AMI due to typical atherosclerosis (AMI-non KD) are unknown.
Aim
The aim of the present study was to examine the current treatment strategy and prognosis of AMI-complicated KD compared with AMI due to typical atherosclerosis.
Method
We used data from 2012 to 2019 from a nationwide claim database, the Japanese Registry of All Cardiac and Vascular Diseases-Diagnosis Procedure Combination.
Results
Compared to the AMI-non KD patients (n = 70,227), the AMI-complicated KD patients (n = 73): (1) underwent percutaneous coronary intervention (PCI) less often and more coronary artery bypass grafting, intracoronary thrombolysis or intravenous coronary thrombolysis more often; (2) underwent stentless PCI using old balloon angioplasty or rotablator, when they underwent PCI; and (3) needed in-hospital cardiopulmonary resuscitation and intensive mechanical therapy such as intra-aortic balloon pump, percutaneous cardiopulmonary support or a respirator. Both the AMI-non KD and AMI-complicated KD patients had similar in-hospital mortality rates.
Conclusions
Compared with AMI-non KD patients, AMI-complicated KD patients underwent non-PCI strategies such as bypass surgery or thrombolysis, and required intensive therapy with mechanical supports more often, but presented similar in-hospital mortality. When the AMI-complicated KD patients underwent PCI, stentless PCI using balloon angioplasty or rotablator was performed more often compared with the AMI-non KD patients.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Oct 2022; epub ahead of print
Anzai F, Yoshihisa A, Takeishi R, Hotsuki Y, ... Misaka T, Takeishi Y
Catheter Cardiovasc Interv: 31 Oct 2022; epub ahead of print | PMID: 36316815
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Impact:
Abstract

Stent expansion of restrictive Fontan conduits to nominal diameter and beyond.

Salaets T, Cools B, De Meester P, Heying R, ... Budts W, Gewillig M
Background
Mechanical factors may cause bottlenecks in a Fontan circuit. Extracardiac conduits (ECC) are placed at a young age, but the materials do not allow growth. Restriction in ECC dimensions may deteriorate the function of the circuit.
Aims
This study aimed to evaluate the feasibility and safety of stent expansion of an ECC to the nominal dimension at the time of implant and, if possible, beyond nominal.
Methods
Retrospective, single-center observational review of all ECC Fontan patients who received a stent to expand a previously placed surgical conduit.
Results
A total of 44 restrictive conduits were stented over a 14-year study period with a median of 11.8 (interquartile ranges [IQR]: 9.1-13.8) years after ECC placement. Cross-sectional areas were a median of 30% (IQR: 21-42) smaller than the originally placed ECC; there was no gradient in 23/44 patients and in 21/44, a minimal gradient of 1.3 ± 0.5 (range 1-3 mmHg). All conduits could be enlarged with a significant (p < 0.0001) increase in diameter from 13.6 ± 1.8 to 19.2 ± 1.2 mm, corresponding to a median cross-sectional area increase of 171% (IQR: 153-220). In three patients where the conduits were not contracted, expansion of between 127% and 165% was obtained. There were no conduit ruptures and only one minor complication.
Conclusions
ECC in some Fontan patients become smaller than nominal over time, usually without overt symptoms. The dimensions of ECC\'s can be safely and significantly increased to nominal or even beyond employing stenting. It allows adjustment of ECC dimensions to compensate for somatic growth.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print
Salaets T, Cools B, De Meester P, Heying R, ... Budts W, Gewillig M
Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print | PMID: 36321584
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Impact:
Abstract

Right atrial structural remodeling predict worse outcomes in transcatheter mitral valve repair.

Miller MS, Cutts J, Donatelle M, Shah K, ... Bilchick K, Mazimba S
Background
In the current study, we assess the predictive role of right and left atrial volume indices (RAVI and LAVI) as well as the ratio of RAVI/LAVI (RLR) on mortality following transcatheter mitral valve repair (TMVr).
Methods
Transthoracic echocardiograms of 158 patients who underwent TMVr at a single academic medical center from 2011 to 2018 were reviewed retrospectively. RAVI and LAVI were calculated using Simpson\'s method. Patients were stratified based on etiology of mitral regurgitation (MR). Cox proportional-hazard regression was created utilizing MR type, STS-score, and RLR to assess the independent association of RLR with survival. Kaplan-Meier analysis was used to analyze the association between RAVI and LAVI with all-cause mortality. Hemodynamic values from preprocedural right heart catheterization were also compared between RLR groups.
Results
Among 123 patients included (median age 81.3 years; 52.5% female) there were 50 deaths during median follow-up of 3.0 years. Patients with a high RAVI and low LAVI had significantly higher all-cause mortality while patients with high LAVI and low RAVI had significantly improved all-cause mortality compared to other groups (p = 0.0032). RLR was significantly associated with mortality in patients with both functional and degenerative MR (p = 0.0038). Finally, Cox proportion-hazard modeling demonstrated that an elevated RLR above the median value was an independent predictor of all-cause mortality [HR = 2.304; 95% CI = 1.26-4.21, p = 0.006] when MR type and STS score were accounted for.
Conclusion
Patients with a high RAVI and low LAVI had significantly increased mortality than other groups following TMVr suggesting RA remodeling may predict worse outcomes following the procedure. Concordantly, RLR was predictive of mortality independent of MR type and preprocedural STS-score. These indices may provide additional risk stratification in patients undergoing evaluation for TMVr.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print
Miller MS, Cutts J, Donatelle M, Shah K, ... Bilchick K, Mazimba S
Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print | PMID: 36321593
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Impact:
Abstract

Prediction of functional results of percutaneous coronary interventions with virtual stenting and quantitative flow ratio.

Lee HJ, Mejía-Rentería H, Escaned J, Doh JH, ... Shin ES, Koo BK
Background
The clinical value of residual quantitative flow ratio (rQFR), a novel function of QFR technique, is unknown.
Aim
We investigated the clinical value of rQFR, aimed to predict residual ischemia after virtual percutaneous coronary intervention (vPCI).
Methods
This is a substudy of the COE-PERSPECTIVE registry, which investigated the prognostic value of post-PCI fractional flow reserve (FFR). From pre-PCI angiograms, QFR and rQFR were analyzed and their diagnostic performance was assessed at blinded fashion using pre-PCI FFR and post-PCI FFR as reference, respectively. The prognostic value of rQFR after vPCI was assessed according to vessel-oriented composite outcome (VOCO) at 2 years.
Results
We analyzed 274 patients (274 vessels) with FFR-based ischemic causing lesions (49%) from 555 screened patients. Pre-PCI QFR and FFR were 0.63 ± 0.10 and 0.66 ± 0.11 (R = 0.756, p < 0.001). rQFR after vPCI and FFR after real PCI were 0.93 ± 0.06 and 0.86 ± 0.07 (R = 0.528, p < 0.001). The mean difference between rQFR and post-PCI FFR was 0.068 (95% limit of agreement: -0.05 to 0.19). Diagnostic performance of rQFR to predict residual ischemia after PCI was good (area under the curve [AUC]: 0.856 [0.804-0.909], p < 0.001). rQFR predicted well the incidence of 2-year VOCO after index PCI (AUC: 0.712 [0.555-0.869], p = 0.041), being similar to that of actual post-PCI FFR (AUC: 0.691 [0.512-0.870], p = 0.061). rQFR ≤0.89 was associated with increased risk of 2-year VOCO (hazard ratio [HR]: 12.9 [2.32-71.3], p = 0.0035). This difference was mainly driven by a higher rate of target vessel revascularization (HR: 16.98 [2.33-123.29], p = 0.0051).
Conclusions
rQFR estimated from pre-PCI angiography and virtual coronary stenting mildly overestimated functional benefit of PCI. However, it well predicted suboptimal functional result and long-term vessel-related clinical events.
Clinical trial registration
Influence of fractional flow reserve on the Clinical OutcomEs of PERcutaneouS Coronary Intervention (COE-PESPECTIVE) Registry, NCT01873560.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print
Lee HJ, Mejía-Rentería H, Escaned J, Doh JH, ... Shin ES, Koo BK
Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print | PMID: 36321601
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Impact:
Abstract

Diagnostic accuracy of angiography-based vessel fractional flow reserve after chronic coronary total occlusion recanalization.

Scoccia A, Scarparo P, Neleman T, Kakar H, ... Daemen J, Diletti R
Background
Angiography-based vessel fractional flow reserve (vFFR) demonstrated a strong correlation with invasive fractional flow reserve (FFR) in both a pre- and post-percutaneous coronary intervention (PCI) setting. However, the role of vFFR and its correlation with post-PCI FFR in chronic coronary occlusions (CTO) has not been evaluated yet. We sought to investigate the diagnostic performance of post-PCI vFFR with post-PCI FFR as a reference in patients undergoing successful CTO PCI.
Methods
Between March 2016 and April 2020, a total of 80 patients from the FFR-SEARCH (prospective registry) and FFR REACT (randomized controlled trial) studies underwent successful CTO recanalization with post-PCI FFR measurements.
Results
A total of 50 patients (median age 66 (interquartile range [IQR]: 56-74) years, 76% were male) were eligible for the analysis. Median post-PCI FFR was 0.89 (IQR: 0.84-0.94), while median post-PCI vFFR was 0.91 (IQR: 0.85-0.94) (p 0.10). Suboptimal physiological results, defined as FFR and vFFR <0.90, were identified in 26 (52%) and in 21 (42%) patients, respectively. A strong correlation (r = 0.82) was found between vFFR and FFR with a mean bias of 0.013 ± 0.051. Receiver-operating characteristics curve analysis revealed an excellent accuracy of vFFR in predicting FFR <0.90 (area under the curve: 0.97; 95% confidence interval: 0.93-1.00).
Conclusion
Post-PCI vFFR shows a good correlation with post-PCI FFR and a high diagnostic accuracy for post-PCI FFR ≤0.90 in patients undergoing successful PCI of a CTO lesion.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print
Scoccia A, Scarparo P, Neleman T, Kakar H, ... Daemen J, Diletti R
Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print | PMID: 36321612
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Impact:
Abstract

A new FDA approved stent for congenital heart disease: First-in-man experiences with G-ARMOR.

Morgan GJ, Zablah J
We present the first clinical experience with a new hybrid cell structure covered stent, designed for congenital heart disease applications. It represents a significant redesign of the Cheatham Platinum (CP) Stent (Numed Inc.), maintaining the traditional benefits of the covered CP whilst significantly decreasing shortening and allowing controlled flaring at the ends through its combination of larger and standard sized cells. We first implanted the stent in 2 patients with superior sinus venosus defects with anomalous drainage of the right upper and middle lobe pulmonary veins. The first was a 40 year male and the second a 36 year old female. The third case was a 60 year old patient with near atresia of the aorta, with pre and poststenotic aortic dilation. The clinical result in all cases was excellent with no obstruction to pulmonary venous return and no visible L-R shunt on the transthoracic echo on 24 h and 2 week follow-up for the patient with sinus venosus defects and uniform complete revascularization of the aorta without any vascular complications in the patient with coarctation. These are the first uses of this stent in human subjects. The design is specifically aimed toward procedures where stent shortening is undesirable. Hence, coarctation of the aorta as well as stent implantation in preparation for percutaneous pulmonary valve placement are obvious use areas, as well as the growing body of evidence supporting percutaneous treatment of sinus venosus defects.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print
Morgan GJ, Zablah J
Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print | PMID: 36321626
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Impact:
Abstract

Three versus 12-month dual antiplatelet therapy duration in patients with acute coronary syndrome undergoing percutaneous coronary intervention: A meta-analysis of randomized controlled trials.

Selvaraj V, Chatterjee S, Hirai T, Abbott JD, Bavishi C
Introduction
The American Heart Association/American College of Cardiology guidelines on dual antiplatelet therapy (DAPT) recommend at least 12 months of a P2Y12 inhibitor and low dose aspirin in patients with an acute coronary syndrome (ACS) treated with a stent. Since that recommendation, several randomized controlled trials (RCTs) have studied an abbreviated duration of DAPT in ACS. Therefore, we sought to perform a meta-analysis of RCTs comparing 3- versus 12-month DAPT in patients presenting with ACS undergoing percutaneous coronary intervention (PCI).
Methods
PubMed, Embase, and Cochrane Central databases were searched until July 31, 2022, for RCTs comparing 3- versus 12-month DAPT in patients with ACS undergoing PCI. Outcomes assessed were major adverse cardiovascular events (MACE), cardiovascular mortality, all-cause mortality, myocardial infarction (MI), stent thrombosis (ST) and bleeding. A random-effects model was used to calculate pooled relative risk (RR) and 95% confidence intervals (CI).
Results
We included 5 trials comprising 16,781 patients with an ACS that underwent PCI. There was no significant difference in MACE (RR: 0.92; 95% CI: 0.76-1.11), cardiovascular mortality (RR: 1.26; 95% CI: 0.38-4.17), or all-cause mortality (RR: 0.92; 95% CI: 0.48-1.77) between the 2 groups. In addition, there was no difference in rates of MI (RR: 0.98; 95% CI: 0.74-1.30), or ST (RR: 1.30; 95% CI: 0.55-3.05) between 3- and 12-month DAPT. However, compared with 12-month DAPT, 3-month DAPT significantly reduced risk of major bleeding (RR: 0.53; 95% CI: 0.43-0.64).
Conclusions
In patients with ACS undergoing PCI, 3-month DAPT reduced risk of bleeding without evidence of harm.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 03 Nov 2022; epub ahead of print
Selvaraj V, Chatterjee S, Hirai T, Abbott JD, Bavishi C
Catheter Cardiovasc Interv: 03 Nov 2022; epub ahead of print | PMID: 36326115
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Impact:
Abstract

Hybrid coronary revascularization (HCR) versus coronary artery bypass grafting (CABG) in multivessel coronary artery disease (MVCAD): A meta-analysis of 14 studies comprising 4226 patients.

Nagraj S, Tzoumas A, Kakargias F, Giannopoulos S, ... Alvarez Villela M, Latib A
Objectives
To compare the outcomes of hybrid coronary revascularization (HCR) with traditional coronary artery bypass grafting (CABG) in multivessel coronary artery disease (MVCAD).
Background
HCR has emerged as an alternative to CABG in patients with MVCAD. Through minimally invasive surgical techniques, HCR carries the potential for faster recovery postoperatively, fewer complications, and lower utilization of resources.
Methods
Systematic search of electronic databases was conducted up to December 2021 and studies comparing HCR with CABG in the treatment of MVCAD were included in this meta-analysis. Primary outcomes of interest were incidence of 5-year mortality and major adverse cardiac and cerebral event (MACCE).
Results
Fourteen studies (12 observational studies and 2 randomized controlled trials) comprising 4226 patients were included. The rates of 5-year mortality (odds ratios [OR]: 1.55; 95% confidence interval [CI]: 0.92-2.62; I2  = 83.0%) and long-term MACCE (OR: 0.97; 95% CI: 0.47-2.01; I2  = 74.7%) were comparable between HCR and CABG groups. HCR was associated with a significantly lower likelihood of perioperative blood transfusion (OR: 0.36; 95% CI: 0.25-0.51; I2  = 55.9%), shorter mean hospital stay (weighted mean difference: -2.04; 95% CI: -2.60 to -1.47; I2  = 54%), and risk of postoperative acute kidney injury (OR: 0.45; 95% CI: 0.23-0.88; p = 0.02). CABG demonstrated a lower likelihood of requiring long-term repeat revascularization (OR: 1.51; 95% CI: 1.03-2.20; I2  = 18%) over a follow-up duration of 29.14 ± 21.75 months.
Conclusion
This meta-analysis suggests that HCR is feasible and safe for the treatment of MVCAD. However, benefits of HCR should be carefully weighed against the increased long-term risk of repeat-revascularization when selecting patients, and further studies evaluating differences in long-term mortality between HCR and CABG are required.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 06 Nov 2022; epub ahead of print
Nagraj S, Tzoumas A, Kakargias F, Giannopoulos S, ... Alvarez Villela M, Latib A
Catheter Cardiovasc Interv: 06 Nov 2022; epub ahead of print | PMID: 36335643
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Impact:
Abstract

Comparison of outcomes in patients with or without ARC-HBR criteria undergoing PCI with polymer-free biolimus coated stents: The BioFreedom France study.

Garot P, Brunel P, Dibie A, Morelle JF, ... Lipiecki J, BioFreedom France Investigators
Background
The polymer-free biolimus coated stent (BioFreedom) was shown to be superior to bare metal stents in the LEADERS FREE randomized trial in high bleeding risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT). However, there is limited outcome data with this device in an all-comers\' population.
Methods
We conducted a prospective single-arm study of patients undergoing percutaneous coronary intervention with the polymer-free biolimus coated stent in 25 centers in France with wide inclusion criteria including multivessel disease, complex lesions, and acute coronary syndromes. The primary endpoint was the incidence of target lesion failure (TLF), a composite of cardiac death or target-vessel myocardial infarction (MI) or clinically indicated target lesion revascularization (ci-TLR) at 1-year. The patient population was classified according to the presence (or not) of HBR criteria according to the recent ARC-HBR definition.
Results
Between April 2019 and April 2020, 1497 patients were enrolled. TLF occurred in 101 (6.9%) patients, including cardiac death in 35 (2.4%), target vessel MI in 20 (1.4%) and ci-TLR in 65 (4.5%) of them. There were 491 HBR patients (32.8%) and 1006 non-HBR patients. The median duration of DAPT was 74 days in the HBR group versus 348 days in the non-HBR group (p < 0.0001). TLF occurred in 44 (9.2%) of the HBR group and in 57 (5.8%) of the non-HBR group (relative risk 1.62 [95% confidence interval: 1.10-2.41], p = 0015). Compared to the non-HBR group, HBR patients had higher rates of cardiac death (4.4% vs. 1.4%, p = 0.0005) and target vessel MI (2.9% vs. 0.6%, p = 0.0003), but similar rates of ci-TLR. BARC 3-5 bleeding occurred in 6.2% of the HBR group versus 1.4% of the non-HBR group (p < 0.0001).
Conclusion
In this multicenter all-comers study, HBR patients treated with a polymer-free biolimus coated stent had, compared to non-HBR patients, an increased risk of cardiac death and MI, and despite a shorter duration of DAPT, continued to have higher rates of BARC 3-5 bleeding.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print
Garot P, Brunel P, Dibie A, Morelle JF, ... Lipiecki J, BioFreedom France Investigators
Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print | PMID: 36378683
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Impact:
Abstract

Risk factors for percutaneous left ventricular assist device explant complications.

Schott JP, Rusia A, Lynch S, Tawney A, ... Balla AK, Hanson ID
Introduction
Percutaneous left ventricular assist device (pLVAD) explant remains nonstandardized with potential complications of bleeding and thrombosis. Explant settings include percutaneous techniques in the catheterization laboratory (CL), manually at bedside (MB), and surgically in the operating room (OR).
Objective
Identify high-risk features for explant-related complications, including indication for support, setting, and technique.
Methods
Postexplant bleeding and thrombosis/limb ischemia were identified following pLVAD removals over 2 years at a multicenter healthcare system.
Results
Of 156 patients, bleeding (n = 26 [17%]) and thrombosis (n = 9 [6%]) occurred more often in patients with the peripheral arterial disease (PAD), female gender, anemia, and cardiogenic shock. OR explants had a higher combined endpoint (4/8 [50%]) versus CL (23/133 [17%], p < 0.05) driven by transfusion. There was no difference between OR versus MB (5/15 [33%], p = 0.66) or CL versus MB (p = 0.62). In shock patients, there was no difference between CL (7/30 [23%]) versus MB (5/15 [33%], p = 0.5) and OR (4/7 [57%], p = 0.16); or MB versus OR (p = 0.38). Average length of stay was significantly lower in the CL group versus MB and OR (3.6 ± 33.2 vs. 18.4 ± 10.9 vs. 28.1 ± 15.8 days, p < 0.0001). Preclosure in shock patients (5/25 [20%] vs. 11/27 [41%], p = 0.1383) and crossover balloon occlusion technique (9/44 [16%] vs. 25/112 [22%]; p = 1) were not associated with higher combined endpoints versus control.
Conclusion
Risk factors for pLVAD explant complications include PAD, female gender, and cardiogenic shock. There was no difference in complication rates between explant settings among cardiogenic shock patients, but shorter length of stay when performed in the CL. There was no difference in complication rates when using the crossover balloon occlusion technique.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print
Schott JP, Rusia A, Lynch S, Tawney A, ... Balla AK, Hanson ID
Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print | PMID: 36378715
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Impact:
Abstract

Unrecoverable stent deformation in the left main: Crush it or remove it?

Achim A, Krivoshei L, Leibundgut G
Serial ostial and distal left main lesions continue to be one of the most difficult tasks for the interventional cardiologist, with many potential complications occurring. We present such a high-risk percutaneous coronary intervention where immediate stent explantation was deemed necessary because the metal deformation and high radial strength of the particular stent platform would prevent an acceptable procedural result if it had been crushed to the vessel wall. The aim of this paper was to discuss left main stent deformation, debate the risks and benefits of stent explantation and finally test in-vitro our theory on \"insufficient\" crush with stents with high radial strength and compare it with conventional stents. Bench-testing supports our ad-hoc explantation decision showing stent underexpansion, recoil, and malapposition, obtaining an inadequate minimal stent area.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print
Achim A, Krivoshei L, Leibundgut G
Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print | PMID: 36378603
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Impact:
Abstract

SCAI stage reclassification at 24 h predicts outcome of cardiogenic shock: Insights from the Altshock-2 registry.

Morici N, Frea S, Bertaina M, Sacco A, ... Tavazzi G, Pappalardo F
Background
Cardiogenic shock (CS) includes several phenotypes with heterogenous hemodynamic features. Timely prognostication is warranted to identify patients requiring treatment escalation. We explored the association of the updated Society for Cardiovascular Angiography and Interventions (SCAI) stages classification with in-hospital mortality using a prospective national registry.
Methods
Between March 2020 and February 2022 the Altshock-2 Registry has included 237 patients with CS of all etiologies at 11 Italian Centers. Patients were classified according to their admission SCAI stage (assigned prospectively and independently updated according to the recently released version). In-hospital mortality was evaluated for association with both admission and 24-h SCAI stages.
Results
The overall in-hospital mortality was 38%. Of the 237 patients included and staged according to the updated SCAI classification, 20 (8%) had SCAI shock stage B, 131 (55%) SCAI stage C, 61 (26%) SCAI stage D and 25 (11%) SCAI stage E. In-hospital mortality stratified according to the SCAI classification at 24 h was 18% for patients in SCAI stage B, 27% for SCAI stage C, 63% for SCAI stage D and 100% for SCAI stage E. Both the revised SCAI stages on admission and at 24 h were associated with in-hospital mortality, but the classification potential slightly increased at 24-h. After adjusting for age, sex, lactate level, eGFR, CVP, inotropic score and mechanical circulatory support [MCS], SCAI classification at 24 h was an independent predictor of in-hospital mortality.
Conclusions
In the Altshock-2 registry the utility of SCAI shock stages to identify risk of in-hospital mortality increased at 24 h after admission. Escalation of treatment (either pharmacological or with MCS) should be tailored to achieve prompt clinical improvement within the first 24 h after admission. Registration: http://www.
Clinicaltrials
gov; Unique identifier: NCT04295252.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print
Morici N, Frea S, Bertaina M, Sacco A, ... Tavazzi G, Pappalardo F
Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print | PMID: 36378673
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Impact:
Abstract

Transcatheter valve repair of tricuspid regurgitation with the PASCAL system: TriCLASP study 30-day results.

Baldus S, Schofer N, Hausleiter J, Friedrichs K, ... Ren CB, Geisler T
Background
Severe tricuspid regurgitation (TR) is independently associated with increased morbidity and mortality. Percutaneous transcatheter approaches may offer an alternative for patients not amenable to surgery.
Methods
TriCLASP is a prospective, single-arm, multicenter European post-market clinical follow-up study (NCT04614402) to evaluate the safety and performance of the PASCAL system (Edwards Lifesciences) in patients with severe or greater TR. At 30 days, a composite of major adverse events (MAEs) adjudicated by a clinical events committee, echocardiographic parameters adjudicated by core laboratory, and clinical, functional, and quality-of-life measures were evaluated.
Results
Mean age of the 74 enrolled patients was 80.3 years, with 58.1% female, 90.5% systemic hypertension, and 77.0% in New York Heart Association (NYHA) class III/IV. Mean Society for Thoracic Surgeons score (MV repair) was 9.0%. TR severity was significantly reduced at discharge (p &lt; 0.001) and sustained at 30 days (p &lt; 0.001), and 90.0% of patients achieved ≤moderate TR. The composite MAE rate at 30 days was 3.0%, including 4 events in 2 patients: cardiovascular mortality 1.5%, stroke 1.5%, renal complications requiring unplanned dialysis or renal replacement therapy 1.5%, and severe bleeding 1.5%. There were no nonelective tricuspid valve reinterventions, major access site and vascular complications, major cardiac structural complications, or device embolizations. NYHA class I/II was achieved in 55.8%, 6-minute walk distance improved by 38.2 m (p &lt; 0.001), and Kansas City cardiomyopathy questionnaire scores improved by 13.4 points (p &lt; 0.001).
Conclusion
Experience with the PASCAL transcatheter valve repair system in a European post-market setting confirms favorable safety and effectiveness at 30 days. TR significantly reduced, and clinical, functional, and quality-of-life outcomes significantly improved. This study is ongoing. Clinical Trial Registration: The study is ongoing and registered on ClinicalTrials.gov as NCT04614402. The current analysis is an interim report.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print
Baldus S, Schofer N, Hausleiter J, Friedrichs K, ... Ren CB, Geisler T
Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print | PMID: 36378678
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Impact:
Abstract

Chronic total occlusion percutaneous coronary intervention in heart transplant patients.

Azzalini L, Moroni F, Dawson KL, Kearney KE
Cardiac allograft vasculopathy (CAV) is frequently observed after heart transplant (HT), and represents one of the main causes of chronic rejection, graft loss, and death. While the role of percutaneous coronary intervention (PCI) is well established in the management of CAV in cases of nonocclusive stenoses, the outcomes and technical aspects of this procedure in chronic total occlusions (CTOs) are unknown. We describe our experience with three cases in which CTO PCI was indicated to treat CAV in HT recipients, and we discuss the peculiarities and therapeutic approach to this challenging patient population. In particular, all patients were asymptomatic for angina, and CTO PCI was indicated to promote recovery of left ventricular function, extend graft survival, and/or protect from future ischemic events. CTO PCI was performed using hybrid techniques and was successful in all three cases. Intravascular imaging was used in all cases to maximize the durability of the procedure.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print
Azzalini L, Moroni F, Dawson KL, Kearney KE
Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print | PMID: 36378679
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Impact:
Abstract

Underweight and obesity are related to higher mortality in patients undergoing coronary angiography: The KARDIO invasive cardiology register study.

Laukkanen JA, Kunutsor SK, Hernesniemi J, Immonen J, ... Nikus K, KARDIO Study Group
Background
In patients with some cardiovascular disease conditions, slightly elevated body mass index (BMI) is associated with a lower mortality risk (termed \"obesity paradox\"). It is uncertain, however, if this obesity paradox exists in patients who have had invasive cardiology procedures. We evaluated the association between BMI and mortality in patients who underwent coronary angiography.
Methods
We utilised the KARDIO registry, which comprised data on demographics, prevalent diseases, risk factors, coronary angiographies, and interventions on 42,636 patients. BMI was categorised based on WHO cut-offs or transformed using P-splines. Hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated for all-cause mortality.
Results
During a median follow-up of 4.9 years, 4688 all-cause deaths occurred. BMI was nonlinearly associated with mortality risk: compared to normal weight category (18.5-25 kg/m2 ), the age-adjusted HRs (95% CIs) for all-cause mortality were 1.90 (1.49, 2.43), 0.96 (0.92, 1.01), 1.04 (0.99, 1.09), 1.08 (0.96, 1.20), and 1.45 (1.22, 1.72) for underweight (<18.5 kg/m2 ), preobesity (25 to <30 kg/m2 ), obesity class I (30 to <35 kg/m2 ), obesity class II (35 to <40 kg/m2 ), and obesity class III (>40 kg/m2 ), respectively. The corresponding multivariable adjusted HRs (95% CIs) were 2.00 (1.55, 2.58), 0.92 (0.88, 0.97) 1.01 (0.95, 1.06), 1.10 (0.98, 1.23), and 1.49 (1.26, 1,78), respectively.
Conclusions
In patients undergoing coronary angiography, underweight and obesity class III are associated with increased mortality risk, and the lowest mortality was observed in the preobesity class. It appears the obesity paradox may be present in patients who undergo invasive coronary procedures.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print
Laukkanen JA, Kunutsor SK, Hernesniemi J, Immonen J, ... Nikus K, KARDIO Study Group
Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print | PMID: 36378689
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Impact:
Abstract

Impact of acute coronary syndrome on clinical outcomes after revascularization with the dual-therapy CD34 antibody-covered sirolimus-eluting Combo stent and the sirolimus-eluting Orsiro stent.

Jakobsen L, Christiansen EH, Freeman P, Kahlert J, ... Hansen HS, Jensen LO
Objectives
To compare the efficacy and safety of the dual-therapy CD34 antibody-covered sirolimus-eluting Combo stent (DTS) and the sirolimus-eluting Orsiro stent (O-SES) in patients with and without acute coronary syndrome (ACS) included in the SORT OUT X study.
Background
The incidence of target lesion failure (TLF) after treatment with modern drug-eluting stents has been reported to be significantly higher in patients with ACS when compared to patients without ACS. Whether the results from the SORT OUT X study apply to patients with and without ACS remains unknown.
Methods
In total, 3146 patients were randomized to stent implantation with DTS (n = 1578; ACS: n = 856) or O-SES (n = 1568; ACS: n = 854). The primary end point, TLF, was a composite of cardiac death, target-lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 1 year.
Results
At 1 year, the rate of TLF was higher in the DTS group compared to the O-SES group, both among patients with ACS (6.7% vs. 4.1%; incidence rate ratio: 1.65 [95% confidence interval, CI: 1.08-2.52]) and without ACS (6.0% vs. 3.2%; incidence rate ratio: 1.88 [95% CI: 1.13-3.14]). The differences were mainly explained by higher rates of TLR, whereas rates of cardiac death and target lesion MI did not differ significantly between the two stent groups in patients with or without ACS
Conclusion:
Compared to the O-SES, the DTS was associated with a higher risk of TLF at 12 months in patients with and without ACS. The differences were mainly explained by higher rates of TLR.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print
Jakobsen L, Christiansen EH, Freeman P, Kahlert J, ... Hansen HS, Jensen LO
Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print | PMID: 36378691
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Impact:
Abstract

Trans-caval aspiration artherectomy/thrombectomy of large mobile plaques and thrombi in aortic arch and descending aorta.

Chiang M, Villablanca PA, O\'Neill WW, Frisoli T
Aspiration thrombectomy with the AngioVac is approved for percutaneous removal of thrombus in the venous system. While not approved for aspiration of thrombus or other mass in the left heart or arterial system, it has been used in that setting. Patients with left heart or arterial mass are often deemed unfavorable for surgery and treated conservatively. This may not be the best option for all patients, as some may have lesions that represent a short-term increased risk of complications, for which intervention and aspiration could be considered reasonable. Unfortunately, femoral arteries sizes often cannot accommodate the Angiovac current aspiration cannula dimensions. Here, we demonstrated trans-caval approach for aspiration thrombectomy of extensive aortic mobile plaque and thrombus.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print
Chiang M, Villablanca PA, O'Neill WW, Frisoli T
Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print | PMID: 36378598
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Impact:
Abstract

Clinical and echocardiographic outcomes with new-onset left bundle branch block after SAPIEN-3 transcatheter aortic valve replacement.

Sammour YM, Lak H, Chahine J, Abushouk A, ... Krishnaswamy A, Kapadia SR
Background
New-onset left bundle branch block (LBBB) can develop after transcatheter aortic valve replacement (TAVR) resulting in worse outcomes.
Aims
Describe clinical and echocardiographic outcomes with new-onset LBBB after TAVR.
Methods
We included consecutive patients who underwent transfemoral-TAVR with SAPIEN-3 (S3) valve between April 2015 and December 2018. Exclusion criteria included pre-existing LBBB, right BBB, left anterior hemiblock, left posterior hemiblock, wide QRS ≥ 120ms, prior permanent pacemaker (PPM), and nontransfemoral access.
Results
Among 612 patients, 11.4% developed new-onset LBBB upon discharge. The length of stay was longer with new-onset LBBB compared with no LBBB [3 (2-5) days versus 2 (1-3) days; p < 0.001]. New-onset LBBB was associated with higher rates of 30-day PPM requirement (18.6% vs. 5.4%; p < 0.001) and 1-year heart failure hospitalizations (10.7% vs. 4.4%; p = 0.033). There was no difference in 3-year mortality between both groups (30.9% vs. 30.6%; p = 0.829). Further, new-onset LBBB was associated with lower left ventricular ejection fraction (LVEF) at both 30 days (55.9 ± 11.4% vs. 59.3 ± 9%; p = 0.026) and 1 year (55 ± 12% vs. 60.1 ± 8.9%; p = 0.002). These changes were still present when we stratified patients according to baseline LVEF (≥50% or <50%). New-onset LBBBs were associated with a higher 1-year LV end-diastolic volume index (51.4 ± 18.6 vs. 46.4 ± 15.1 ml/m2 ; p = 0.036), and LV end-systolic volume index (23.2 ± 14.1 vs. 18.9 ± 9.7 ml/m2 ; p = 0.009). Compared with resolved new-onset LBBB, persistent new-onset LBBB was associated with worse LVEF and higher PPM at 1 year.
Conclusions
New-onset LBBB after S3 TAVR was associated with higher PPM requirement, worse LVEF, higher LV volumes, and increased heart failure hospitalizations, with no difference in mortality.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print
Sammour YM, Lak H, Chahine J, Abushouk A, ... Krishnaswamy A, Kapadia SR
Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print | PMID: 36378620
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Impact:
Abstract

Bail out lithotripsy to treat delayed valve-in-valve TAVR-related coronary obstruction.

Bingen BO, Al Amri I, Montero-Cabezas JM, van der Kley F
Coronary access difficulty and stent compression by the juxtaposed aortic valve leaflet hamper percutaneous management of delayed coronary artery obstruction (CAO) after valve-in-valve (Edwards Sapien 3 in St. Jude Trifecta) transcatheter aortic valve replacement (TAVR). Here, we present a case of delayed post-TAVR CAO treated with intravascular lithotripsy and multistenting to overcome stent compression by the adjacent calcified leaflet.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 16 Nov 2022; epub ahead of print
Bingen BO, Al Amri I, Montero-Cabezas JM, van der Kley F
Catheter Cardiovasc Interv: 16 Nov 2022; epub ahead of print | PMID: 36385465
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Impact:
Abstract

Long-term outcomes after paclitaxel-coated balloon angioplasty of femoropopliteal arteries in Asian patients of the IN.PACT Global Study.

Ko YG, Choi D, Rha SW, Won JH, ... Menk JS, Kum S
Objectives
The long-term data on the use of drug-coated balloons (DCBs) for femoropopliteal atherosclerotic lesions in the real-world setting are limited, even more so for racially and geographically distinct populations. The present analysis reports the 5-year safety and effectiveness outcomes of a DCB in the Asian subset of the prospective, real-world IN.PACT Global Study.
Methods
The IN.PACT Global Study was a prospective, multicenter, international, single-arm study designed to assess the long-term safety and effectiveness of the IN.PACT Admiral DCB in real-world participants with femoropopliteal artery disease. The present analysis included 114 Asian participants (138 lesions) treated in South Korea and Singapore. Assessments through 5 years included freedom from clinically driven target lesion revascularization, the safety endpoint (a composite of freedom from device- and procedure-related mortality through 30 days; and freedom from major target limb amputation and clinically driven target vessel revascularization within 60 months after the index procedure) and major adverse events.
Results
In this prespecified Asian subset, there was a high incidence of diabetes mellitus (54.4%), hypertension (78.1%), coronary artery disease (43.9%), and concomitant below-the-knee vascular disease of target leg (39.5%). Mean lesion length was 17.4 ± 12.4 cm; 26.8% were in-stent restenosis, and more than half of the lesions were totally occluded (51.4%) and calcified (54.3%). The 5-year Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization was 77.1% (95% confidence interval: 67.0%-84.5%). The safety composite endpoint was 76.0%; the cumulative incidence of all-cause mortality was 19.9%, and no major target limb amputations were reported through 5 years.
Conclusions
This subset analysis of Asian participants from the IN.PACT Global Study demonstrated consistent results with the previously reported data of the IN.PACT Admiral DCB. The data confirm the durable clinical effectiveness and safety profile of the DCB through 5 years for femoropopliteal atherosclerotic disease in this real-world population.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 16 Nov 2022; epub ahead of print
Ko YG, Choi D, Rha SW, Won JH, ... Menk JS, Kum S
Catheter Cardiovasc Interv: 16 Nov 2022; epub ahead of print | PMID: 36385562
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Impact:
Abstract

A word of caution: Early failure of Magmaris® bioresorbable stent after pulmonary artery stenting.

Haddad RN, Adel Hassan A, Al Soufi M, Kasem M
Bioresorbable scaffolds (BRS) have been advocated as the fourth revolution in interventional cardiology medical devices with promising technology to improve the treatment of coronary artery disease with an event-free future. We describe the first reported use and early collapse of the Magmaris® Resorbable Magnesium Scaffold (RMS) stent (BIOTRONIK AG, Switzerland) to relieve left pulmonary artery severe stenosis in a newborn after the Norwood procedure. The stent collapse was detected 2 weeks after implantation and urgently treated with a balloon-expandable stent. This complication raises the alarm about the need to keep implanted RMS under scrutiny. The possibility of faster scaffold resorption in small babies or lack of sufficient radial force of RMS to resist acute vessel recoil has led to ineffective relief of branch pulmonary artery stenosis and failure to enable a safe short-term bridge to Stage II palliation.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 22 Nov 2022; epub ahead of print
Haddad RN, Adel Hassan A, Al Soufi M, Kasem M
Catheter Cardiovasc Interv: 22 Nov 2022; epub ahead of print | PMID: 36413609
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Impact:
Abstract

Multimodality imaging results of TAP versus novel modified TAP stenting in coronary bifurcation: From bench testing to first-in-man investigation.

Ng JCK, Ang H, Zhong L, Hakim D, ... Foin N, Leesar MA
Objectives
We investigated the results of T and small protrusion (TAP) versus a novel modification of TAP (mTAP) stenting by multimodality imaging in bench testing and in patients with coronary bifurcation lesions (CBL).
Background
TAP stenting is a suboptimal technique for bailout side branch (SB) stenting.
Methods
In a bench model, optical coherence tomography (OCT), microscopic examinations (ME), and computational fluid dynamics (CFD) were performed after TAP and mTAP stenting. In 20 patients with CBL, 80 intravascular ultrasound (IVUS) examinations were performed during mTAP stenting in which the SB stent was pulled-back to indent the inflated main vessel (MV) balloon and deployed while deflating it. For TAP stenting, the tip of the SB stent was positioned in the MV and deployed.
Results
In bench testing, OCT showed neocarina length (NL) was shorter and minimum stent area (MSA) was larger after mTAP versus TAP stenting (2.84 ± 0.70 vs. 4.80 ± 020 mm; 6.75 ± 1.50 vs. 4.5 ± 2.2 mm2 ; respectively; p < 0.05). By ME, NL was shorter and shear rate trended lower after mTAP versus TAP stenting. In patients, IVUS showed MSA was larger after versus before mTAP stenting (6.32 ± 0.58 vs. 5.21 ± 0.56 mm2 ; p < 0.01); NL was 1.43 ± 0.22 mm with SB ostium coverage. The Seattle Angina questionnaire (SAQ) score was higher at 6 months versus baseline (85 ± 4.0 vs. 48 ± 6.0, respectively; p < 0.001).
Conclusions
This multimodality imaging study showed, for the first time, mTAP stenting resulted in larger stent area and shorter neocarina than TAP stenting in bench testing. In patients with CBL, mTAP stenting led to larger stent area, short neocarina with complete SB ostium coverage, and improved the SAQ score at follow-up.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 20 Nov 2022; epub ahead of print
Ng JCK, Ang H, Zhong L, Hakim D, ... Foin N, Leesar MA
Catheter Cardiovasc Interv: 20 Nov 2022; epub ahead of print | PMID: 36403271
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Impact:
Abstract

Management of a right coronary artery mycotic coronary aneurysm with percutaneous intervention with covered stents.

Price J, Okyere R, Al-Kindi S, Gupta A
Coronary artery aneurysmal dilation is a rare finding with poorly understood mechanism of action that is found in small population of patients undergoing coronary angiography. Mycotic coronary aneurysm is an even rarer cause of coronary aneurysmal dilatation that develops as a potentially fatal complication of bacteremia. We present a case of mycotic right coronary artery aneurysm in a nonsurgical candidate with complex medical comorbidities treated with percutaneous coronary intervention via covered stents.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 20 Nov 2022; epub ahead of print
Price J, Okyere R, Al-Kindi S, Gupta A
Catheter Cardiovasc Interv: 20 Nov 2022; epub ahead of print | PMID: 36403280
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Impact:
Abstract

Correlation of aortic valve annular plane assessment by on-table three-dimensional rotational angiography and preprocedural computed tomography.

Tanner R, Murphy S, Malone C, McGorrian C, ... Margey R, Casserly IP
Objectives
To assess the correlation between the aortic valve annular plane (AVAP) obtained by preprocedural computed tomography (CT) with on-table three-dimensional rotational angiography (3DRA), in patients undergoing transcatheter aortic valve replacement (TAVR).
Background
Accurate assessment of the AVAP is critical during TAVR procedures to enable optimal positioning and minimize complications. Most commonly, preprocedural CT has been used to determine the AVAP. However, this can differ from the actual AVAP obtained during the TAVR procedure.
Methods
Consecutive TAVR patients at a single center undergoing both preprocedural CT and 3DRA were included in the study. The AVAP assessment by CT was performed using 3mensio software (Pie Medical Imaging). 3DRA assessment was performed using DynaCT (Siemens).
Results
A total of 100 patients were included in the analysis. A difference of ≥5° and ≥10° in both the LAO/RAO and cranial/caudal components of the AVAP projection angle as assessed by CT and 3DRA was recorded in 39% and 10% of patients, respectively. The concordance correlation coefficient for the LAO/RAO and cranial/caudal implantation angles was 0.519 (95% CI: 0.377-0.661) and 0.558 (95% CI: 0.432-0.684), respectively.
Conclusion
Correlation between preprocedural CT and on-table 3DRA in the prediction of the actual AVAP at the time of TAVR implantation is moderate.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 20 Nov 2022; epub ahead of print
Tanner R, Murphy S, Malone C, McGorrian C, ... Margey R, Casserly IP
Catheter Cardiovasc Interv: 20 Nov 2022; epub ahead of print | PMID: 36403283
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Impact:
Abstract

Procedural simplification of left atrial appendage occlusion using the VersaCross connect system: First in-human experience.

Perrin N, McAlister C, Tsang M, Mondésert B, Ibrahim R, Saw J
Background
Left atrial appendage occlusion (LAAO) has emerged over the last two decades as an efficient and safe alternative to oral anticoagulation for stroke prevention. However, LAAO remains challenging due to the variety of anatomies and the multiple steps required to complete the procedure.
Aims
We report the first series of in-human experience of the new all-in-one VersaCross Connect system designed to access the left atrium in conjunction with the delivery sheath for deployment of the WATCHMAN FLX device.
Methods
We prospectively included the first nine consecutive cases of LAAO using the new VersaCross Connect system for WATCHMAN FLX device implantation at the Montreal Heart Institute and Vancouver General Hospital and collected procedural duration (defined as time from femoral access to closure) and time from transseptal puncture to device delivery.
Results
VersaCross Connect system use for WATCHMAN FLX implantation was successful in all patients. No procedural complication was reported. Mean procedural time was 31 ± 6.3 min with a fluoroscopy time of 6.7 ± 4.9 min. The mean delay between the transseptal puncture and device implantation was 12.2 ± 1.9 min.
Conclusions
We showed that the VersaCross Connect system was safe and successfully used in all first nine cases. This new system helped improve the efficiency of the procedure.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 22 Nov 2022; epub ahead of print
Perrin N, McAlister C, Tsang M, Mondésert B, Ibrahim R, Saw J
Catheter Cardiovasc Interv: 22 Nov 2022; epub ahead of print | PMID: 36413620
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Impact:
Abstract

Frequency and outcomes of STEMI patients presenting between 12 and 24 h after symptom onset: Late-presenting STEMI.

Griffin ACG, Yildiz M, Bradley S, Smith JE, ... Sharkey SW, Henry TD
Objectives
To assess the characteristics and prognosis of ST-elevation myocardial infarction (STEMI) patients, presenting between 12 and 24 h after symptom onset, in contemporary regional STEMI systems of care in the United States.
Background
Previous observational studies have been inconsistent regarding the benefit of primary percutaneous coronary intervention (PCI) compared with conservative management for late-presenting STEMI patients and the majority of randomized trials are from the fibrinolytic era.
Methods
Using a two-center registry-based cohort from March 2003 to December 2020, we evaluated the frequency, clinical characteristics, and outcomes of STEMI patients, stratified by symptom onset to balloon time: <3, 3-6, 6-12, and 12-24 h (late presenters).
Results
Among 5427 STEMI patients with available symptom onset time, 6.2% were late presenters, which increased to 11% during the early phase of the Covid-19 pandemic. As symptom onset to balloon time increased, patients were more likely to be older, female, and have a history of hypertension and diabetes mellitus. Late presenters with an identifiable culprit lesion were less likely to be revascularized with PCI (96%, 96%, 95%, and 92%; p for trend = 0.004) and had a longer median door-to-balloon time (82, 109, 107, and 117 min; p for trend < 0.001). In-hospital and 1-year death risks were comparable between late and earlier presenters.
Conclusion
Despite the unfavorable risk profile and longer door-to-balloon time, clinical outcomes of late presenters were similar to those presenting within 12 h of symptom onset.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 24 Nov 2022; epub ahead of print
Griffin ACG, Yildiz M, Bradley S, Smith JE, ... Sharkey SW, Henry TD
Catheter Cardiovasc Interv: 24 Nov 2022; epub ahead of print | PMID: 36423258
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Impact:
Abstract

Hybrid approach for harmony transcatheter pulmonary valve replacement.

Shibbani K, Aboulhosn J, Levi D, Mohammad Nijres B, ... Van Arsdell G, Aldoss O
The Harmony™ Transcatheter Pulmonary Valve (Medtronic) was recently approved by the Food and Drug Administration for transcatheter pulmonary valve replacement in native right ventricular outflow tracts. Despite this milestone, some patients have main pulmonary arteries that are severely dilated and continue to require surgical pulmonary valve replacement. The hybrid approach combines surgical creation of a landing zone, transcatheter valve deployment, and suture stabilization of the implanted valve. In this case series, we report the first use of a hybrid approach for Harmony™ transcatheter pulmonary valve replacement. Two cases are reported with varying approaches for surgical creation of a landing zone followed by successful placement of a Harmony™ valve.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 26 Nov 2022; epub ahead of print
Shibbani K, Aboulhosn J, Levi D, Mohammad Nijres B, ... Van Arsdell G, Aldoss O
Catheter Cardiovasc Interv: 26 Nov 2022; epub ahead of print | PMID: 36434791
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Impact:
Abstract

Aortic annulus ellipticity and outcomes after transcatheter aortic valve implantation.

Tomii D, Okuno T, Lanz J, Stortecky S, Windecker S, Pilgrim T
Background
Elliptical shape of the aortic annulus has been associated with an increased risk of device failure after transcatheter aortic valve implantation (TAVI) compared with a circular annular shape.
Aims
To assess the impact of annulus ellipticity on procedural outcomes and device performance in patients undergoing TAVI.
Methods
In a prospective TAVI registry, aortic annulus ellipticity was assessed by preprocedural multidetector computed tomography. The annulus ratios, defined by the ratio of minimum and maximum annulus diameters measured in a transverse double oblique plane, were split into tertiles for comparisons between groups.
Results
A total of 1732 patients undergoing TAVI between August 2007 and June 2020 were included in the present analysis. Patients in the tertile with the most elliptical shape of the annulus were more likely to be female (59.7% vs. 47.9%; p < 0.001) and had a higher Society of Thoracic Surgeons Predicted Risk of Mortality (5.4 ± 3.8 vs. 4.8 ± 3.5; p = 0.002). There were no significant differences in the rate of technical success (95.3% vs. 96.5%; p = 0.235), device success (83.6% vs. 86.5%; p = 0.118) and intended valve performance (90.7% vs. 91.7; p = 0.503) between patients in the most elliptical tertile and the rest. However, valve dislocation/embolization occurred more frequently in patients with elliptical as compared to circular annular shape (2.6% vs. 1.2%; p = 0.046).
Conclusions
Ellipticity of the aortic annulus does not affect procedural and device outcomes in patients undergoing TAVI irrespective of transcatheter heart valve design and generation. https:www.//clinicaltrials.gov. NCT01368250.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 01 Dec 2022; epub ahead of print
Tomii D, Okuno T, Lanz J, Stortecky S, Windecker S, Pilgrim T
Catheter Cardiovasc Interv: 01 Dec 2022; epub ahead of print | PMID: 36453455
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Impact:
Abstract

A novel comprehensive radiation shielding system eliminates need for personal lead aprons in the catheterization laboratory.

Rabah M, Allen S, Abbas AE, Dixon S
Objectives
This clinical study evaluated the efficacy of a novel radiation shielding system for the cardiac catheterization laboratory designed to provide comprehensive protection that obviates the need for personal lead aprons.
Background
Invasive Cardiologists are exposed to occupational health hazards related directly to radiation exposure (RE) and indirectly to the orthopedic burden of wearing only partially protective lead aprons. Innovations to reduce these risks are warranted. A novel comprehensive shielding system (ProtegoTM , Image Diagnostics Inc, Fitchburg, Ma) has been validated in pre-clinical studies to provide excellent radiation protection, sufficient for the State of Michigan to certify it for use without need for personal lead aprons.
Methods
This clinical analysis measured RE to a single Physician operator utilizing the ProtegoTM shield (and not wearing personal lead apron) during routine cardiac catheterization procedures (diagnostic and interventional). RE was measured at both thyroid and waist level with a real-time dosimetry system (RaysafeTM , Billdal, Sweden), calculated on a median per case basis (mrems). Additional parameters collected included procedure type, access site, per case fluoroscopy time, and patient factors including body mass index.
Results
In n=98 cases (25% diagnostic, 75% interventional including 22% chronic total occlusions), median/case RE was 0.4 mrems (thyroid) and 0.2 mrems (waist). RE=0 in 12 cases. In no case did radiation exposure exceed 3.2 mrems.
Conclusion
The ProtegoTM shield system provides excellent RE protection to the Physician operator, without the need for personal lead aprons and has the potential to reduce catheterization laboratory occupational health hazards.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 01 Dec 2022; epub ahead of print
Rabah M, Allen S, Abbas AE, Dixon S
Catheter Cardiovasc Interv: 01 Dec 2022; epub ahead of print | PMID: 36453459
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Abstract

Mechanical thrombectomy versus catheter directed thrombolysis in patients with pulmonary embolism: A multicenter experience.

Inci EK, Khandhar S, Toma C, Licitra G, ... Bashline M, Jaber WA
Objectives
Compare in-hospital outcomes of patients treated with either mechanical thrombectomy (MT) or catheter directed lysis (CDL) in treatment of acute pulmonary embolism (PE).
Methods
This is a multicenter, retrospective cohort study of patients undergoing MT or CDL for acute PE between 2014 and 2021. The primary outcome was the composite of in-hospital death, significant bleed, vascular complication, or need for mechanical support post-procedure. Secondary outcomes included the individual components of the composite outcome in addition to blood transfusions, invasive hemodynamics, echocardiographic data, and intensive care unit (ICU) utilization.
Results
458 patients were treated for PE with 266 patients in the CDL arm and 192 patients in the MT arm. The primary composite endpoint was not significantly different between the two groups with CDL 12% versus MT 11% (p = 0.5). There was a significant difference in total length of ICU time required with more in the CDL group versus MT (3.8 ± 2.0 vs. 2.8 ± 3.0 days, p = 0.009). All other secondary end points showed no significant difference between the groups.
Conclusions
In patients undergoing catheter directed treatment of PE, there was no difference between MT and CDL in terms of in-hospital mortality, bleeds, catheter-related complications, and hemodynamics.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Nov 2022; epub ahead of print
Inci EK, Khandhar S, Toma C, Licitra G, ... Bashline M, Jaber WA
Catheter Cardiovasc Interv: 30 Nov 2022; epub ahead of print | PMID: 36448401
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This program is still in alpha version.