Journal: Catheter Cardiovasc Interv

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Abstract

Transcatheter Fontan completion using novel balloon and stent system.

Aregullin EO, Mohammad Nijres B, Al-Khatib Y, Vettukattil J

Despite advances in percutaneous interventions, transcatheter Fontan completion remains experimental and performed only in select cases. Non-surgical Fontan completion requires surgical preconditioning at an earlier stage of palliation. We describe transcatheter Fontan completion in a 15-year-old male with previously failed surgical Fontan palliation without surgical preconditioning.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 13 Jan 2021; epub ahead of print
Aregullin EO, Mohammad Nijres B, Al-Khatib Y, Vettukattil J
Catheter Cardiovasc Interv: 13 Jan 2021; epub ahead of print | PMID: 33444467
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Abstract

The effect of transcatheter aortic valve implantation approaches on mortality.

Nijenhuis VJ, Meyer A, Brouwer J, Mahmoodi BK, ... Kempfert J, Ten Berg JM
Objectives
We aimed to evaluate the effect of transcatheter aortic valve implantation (TAVI) approaches on mortality and identify effect modifiers and predictors for mortality.
Background
Alternative access routes to transfemoral (TF) TAVI include the surgical intra-thoracic direct-aortic (DA) and transapical (TA) approach. TA TAVI has been associated with a higher mortality rate. We hypothesized that this is related to effect modifiers, in particular the left ventricular ejection fraction (LVEF).
Methods
This multicentre study derived its data from prospective registries. To adjust for confounders, we used propensity-score based, stabilized inverse probability weighted Cox regression models.
Results
In total, 5,910 patients underwent TAVI via TF (N = 4,072), DA (N = 524), and TA (N = 1,314) access. Compared to TF, 30-day mortality was increased among DA (HR 1.87, 95%CI 1.26-2.78, p = .002) and TA (HR 3.34, 95%CI 2.28-4.89, p < .001) cases. Compared to TF, 5-year mortality was increased among TA cases (HR 1.50, 95%CI 1.24-1.83, p < .001). None of the variables showed a significant interaction between the approaches and mortality. An impaired LVEF (≤35%) increased mortality in all approaches.
Conclusions
The surgical intra-thoracic TA and DA TAVI are both associated with a higher 30-day mortality than TF TAVI. TA TAVI is associated with a higher 5-year mortality than TF TAVI. The DA approach may therefore have some advantages over the TA approach when TF access is not feasible.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 13 Jan 2021; epub ahead of print
Nijenhuis VJ, Meyer A, Brouwer J, Mahmoodi BK, ... Kempfert J, Ten Berg JM
Catheter Cardiovasc Interv: 13 Jan 2021; epub ahead of print | PMID: 33443813
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Abstract

Development and validation of a prediction model for angiographic perforation during chronic total occlusion percutaneous coronary intervention: OPEN-CLEAN perforation score.

Hirai T, Grantham JA, Sapontis J, Nicholson WJ, ... Salisbury AC, OPEN CTO Study Group
Background
Perforation is the most frequent complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) and is associated with adverse events including mortality.
Methods
Among 1,000 consecutive patients enrolled in 12 center prospective CTO PCI study (OPEN CTO), all perforations were reviewed by the angiographic core-lab. Eighty-nine patients (8.9%) with angiographic perforation were compared to 911 patients without perforation. We sought to describe the clinical and angiographic predictors of angiographic perforation during CTO PCI and develop a risk prediction model.
Results
Among eight clinically important candidate variables, independent risk factors for perforation included prior CABG (OR 2.0 [95% CI, 1.2-3.3], p < .01), occlusion length (OR 1.2 per 10 mm increase [95% CI, 1.1-1.3], p < .01), ejection fraction (OR 1.2 per 10% decrease [95% CI, 1.1-1.5], p < .01), age (OR 1.3 per 5 year increase [95%CI, 1.1-1.5], p < .01), and heavy calcification (OR 1.7 [95% CI, 1.0-2.7], p = .04). Three other potential candidate variables, glomerular filtration rate, proximal cap ambiguity, and target vessel, were not independently associated with perforation. The model was internally validated using bootstrapping methods. From the full model, a simplified perforation prediction score (OPEN-CLEAN score: CABG, Length [occlusion], EF < 50%, Age, CalcificatioN) was developed, which discriminated the risk of angiographic perforation well (c-statistics = 0.75) and demonstrated good calibration.
Conclusion
This simple 5-variable prediction score may help CTO operators to risk-stratify patients for angiographic perforation using variables available prior to CTO PCI procedures.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 12 Jan 2021; epub ahead of print
Hirai T, Grantham JA, Sapontis J, Nicholson WJ, ... Salisbury AC, OPEN CTO Study Group
Catheter Cardiovasc Interv: 12 Jan 2021; epub ahead of print | PMID: 33438824
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Abstract

Endovascular snare technique to facilitate delivery of self-expanding valve during transcatheter aortic valve-in-valve replacement in angulated aortas: A case series.

Rohm CL, Farhat S, Al-Hijji M, Goel K, ... Gulati R, El Sabbagh A
Background
Transcatheter aortic valve-in-valve replacement (ViV) has been widely accepted as a less invasive alternative to treat failed aortic surgical or transcatheter bioprosthetic valves. Angulated aortas present an additional challenge, particularly when using self-expanding transcatheter heart valves (SE-THV).
Methods
Two patients with failed surgical bioprosthetic aortic valves and one patient with a failed transcatheter bioprosthetic aortic valve underwent transcatheter aortic ViV using SE-THV. All were deemed high-risk for surgical aortic valve replacement by a heart team. All three patients had initial failed SE-THV delivery using a conventional approach with subsequent successful delivery using the endovascular snare technique.
Results
In Cases 1 and 2, the SE-THV was biased towards the greater curve of the angulated aorta and behind the outer frame of the bioprosthetic valve frame. An endovascular snare was deployed through a secondary left femoral artery access, and the valve delivery system was advanced through the snare in the ascending aorta. The snare was tightened around the SE-THV capsule proximal to the hat-marker, allowing deflection of the SE-THV and successful delivery. In Case 3, the SE-THV interacted with the tall frame of a failed SE-THV. A snare via the left femoral artery was deployed in the descending artery. The SE-THV was advanced through the snare, and both the snare and SE-THV were advanced together to the ascending aorta where the SE-THV was deflected and successfully delivered.
Conclusions
The endovascular snare technique is a feasible option for successful delivery of SE-THV during transcatheter aortic ViV in failed transcatheter or surgical bioprosthetic valves in angulated aortas.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 10 Jan 2021; epub ahead of print
Rohm CL, Farhat S, Al-Hijji M, Goel K, ... Gulati R, El Sabbagh A
Catheter Cardiovasc Interv: 10 Jan 2021; epub ahead of print | PMID: 33427384
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Abstract

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

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

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Jan 2021; epub ahead of print
McKenzie A, Zhou C, Svendsen C, Anketell R, ... Yeung M, Stouffer GA
Catheter Cardiovasc Interv: 08 Jan 2021; epub ahead of print | PMID: 33421279
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Abstract

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

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

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 07 Jan 2021; epub ahead of print
Sedaghat A, Nickenig G, Schrickel JW, Ince H, ... Boersma LVA,
Catheter Cardiovasc Interv: 07 Jan 2021; epub ahead of print | PMID: 33417282
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Abstract

Outcomes of transcatheter versus surgical aortic valve replacement among solid organ transplant recipients.

Elbadawi A, Ugwu J, Elgendy IY, Megaly M, ... Goel SS, Gafoor S
Background
There is a paucity of data regarding the outcomes of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) among solid-organ transplant recipients.
Methods
Temporal trends in hospitalizations for aortic valve replacement among solid-organ transplant recipients were determined using the National Inpatient Sample database years 2012-2017. Propensity matching was conducted to compare admissions who underwent TAVR versus SAVR. The primary outcome was in-hospital mortality.
Results
The analysis included 1,730 hospitalizations for isolated AVR; 920 (53.2%) underwent TAVR and 810 (46.7%) underwent SAVR. TAVR was increasingly utilized for solid-organ transplant recipients (P = 0.01), while there was no change in the number of SAVR procedures (P = 0.20). The predictors of undergoing TAVR for solid-organ transplant recipients included older age, diabetes, and prior coronary artery bypass surgery, while TAVR was less likely utilized in small-sized hospitals. TAVR was associated with lower in-hospital mortality after matching (0.9 vs. 4.7%, odds ratio [OR] 0.19; 95% confidence interval [CI] 0.11-0.35, p < .001) and after multivariable adjustment (OR 0.07; 95% CI 0.03-0.21, p < .001). TAVR was associated with lower rate of acute kidney injury, acute stroke, postoperative bleeding, blood transfusion, vascular complications, discharge to nursing facilities, and shorter median length of hospital stay. There was no difference between both groups in the use of mechanical circulatory support, hemodialysis, arrhythmias, or pacemaker insertion.
Conclusion
This contemporary observational nationwide analysis showed that TAVR is increasingly performed among solid-organ transplant recipients. Compared with SAVR, TAVR was associated with lower in-hospital mortality, complications, and shorter length of stay.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 04 Jan 2021; epub ahead of print
Elbadawi A, Ugwu J, Elgendy IY, Megaly M, ... Goel SS, Gafoor S
Catheter Cardiovasc Interv: 04 Jan 2021; epub ahead of print | PMID: 33400380
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Abstract

Safety of same-day discharge after uncomplicated, minimalist transcatheter aortic valve replacement in the COVID-19 era.

Perdoncin E, Greenbaum AB, Grubb KJ, Babaliaros VC, ... Mitchell R, Devireddy CM
Objectives
We sought to evaluate the safety, efficacy and feasibility of same-day discharge after uncomplicated, minimalist TAVR.
Background
At the start of the COVID-19 pandemic, we created a same-day discharge (SDD) pathway after conscious sedation, transfemoral (minimalist) TAVR to help minimize risk of viral transmission and conserve hospital resources. Studies support that next-day discharge (NDD) for carefully selected patients following minimalist TAVR is safe and feasible. There is a paucity of data regarding the safety of SDD after TAVR.
Methods
In-hospital and 30 day outcomes of consecutive patients meeting pre-specified criteria for SDD after minimalist TAVR at our institution between March and July of 2020 were reviewed. Outcomes were compared to a NDD cohort from July 2018 through July 2020 that would have met SDD criteria. Primary endpoints were mortality, delayed pacemaker placement, stroke and cardiovascular readmission at 30 days.
Results
Twenty nine patients were discharged via the SDD pathway after TAVR. 128 prior NDD patients were identified who met all criteria for SDD. The STS scores were similar between the two groups (SDD 2.6% ±1.5 vs. NDD 2.3% ± 1.2). There were no deaths at 30 days in either group. There was no significant difference in delayed pacemaker placement (SDD 0% vs. NDD 0.8%, p > .99) or cardiovascular readmission (SDD 0% vs. NDD 5.5%, p = .35) at 30 days.
Conclusions
Same day discharge following uncomplicated, minimalist TAVR in selected patients appears to be safe, achieving similar 30 day outcomes as a cohort of next day discharge patients.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Dec 2020; epub ahead of print
Perdoncin E, Greenbaum AB, Grubb KJ, Babaliaros VC, ... Mitchell R, Devireddy CM
Catheter Cardiovasc Interv: 30 Dec 2020; epub ahead of print | PMID: 33382519
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Abstract

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

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

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 28 Dec 2020; epub ahead of print
Watanabe Y, Mitomo S, Naganuma T, Takagi K, ... Nakamura S, Colombo A
Catheter Cardiovasc Interv: 28 Dec 2020; epub ahead of print | PMID: 33373092
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Abstract

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

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

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 27 Dec 2020; epub ahead of print
Sogabe K, Koide M, Fukui K, Kato Y, ... Nakamura T, Matoba S
Catheter Cardiovasc Interv: 27 Dec 2020; epub ahead of print | PMID: 33369836
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Abstract

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

Tanseco KV, Alsanjari O, Cockburn J, Hildick-Smith D

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

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 21 Dec 2020; epub ahead of print
Tanseco KV, Alsanjari O, Cockburn J, Hildick-Smith D
Catheter Cardiovasc Interv: 21 Dec 2020; epub ahead of print | PMID: 33351217
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Abstract

Dedicated plug based closure for large bore access -The MARVEL prospective registry.

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

© 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 20 Dec 2020; epub ahead of print
Kroon HG, Tonino PAL, Savontaus M, Amoroso G, ... Wood D, Van Mieghem NM
Catheter Cardiovasc Interv: 20 Dec 2020; epub ahead of print | PMID: 33347739
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Impact:

This program is still in alpha version.