Diagnostic accuracy of quantitative flow ratio for assessment of coronary stenosis significance from a single angiographic view: A novel method based on bifurcation fractal law.

Tu S, Ding D, Chang Y, Li C, Wijns W, Xu B
Objectives
We aimed to evaluate the diagnostic accuracy of computation of fractional flow reserve (FFR) from a single angiographic view in patients with intermediate coronary stenosis.
Background
Computation of quantitative flow ratio (QFR) from a single angiographic view might increase the feasibility of routine use of computational FFR. In addition, current QFR solutions assume a linear tapering of the reference vessel size, which might decrease the diagnostic accuracy in the presence of the physiologically significant bifurcation lesions.
Methods
An artificial intelligence algorithm was proposed for automatic delineation of lumen contours of major epicardial coronary arteries including their side branches. A step-down reference diameter function was reconstructed based on the Murray bifurcation fractal law and used for QFR computation. Validation of this Murray law-based QFR (μQFR) was performed on the FAVOR II China study population. The μQFR was computed separately in two angiographic projections, starting with the one with optimal angiographic image quality. Hemodynamically significant coronary stenosis was defined by pressure wire-derived FFR ≤0.80.
Results
The μQFR was successfully computed in all 330 vessels of 306 patients. There was excellent correlation (r = 0.90, p < .001) and agreement (mean difference = 0.00 ± 0.05, p = .378) between μQFR and FFR. The vessel-level diagnostic accuracy for μQFR to identify hemodynamically significant stenosis was 93.0% (95% CI: 90.3 to 95.8%), with sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio of 87.5% (95% CI: 80.2 to 92.8%), 96.2% (95% CI: 92.6 to 98.3%), 92.9% (95% CI: 86.5 to 96.9%), 93.1% (95% CI: 88.9 to 96.1%), 23.0 (95% CI: 11.6 to 45.5), 0.13 (95% CI: 0.08 to 0.20), respectively. Use of suboptimal angiographic image view slightly decreased the diagnostic accuracy of μQFR (AUC = 0.97 versus 0.92, difference = 0.05, p < .001). Intra- and inter-observer variability for μQFR computation was 0.00 ± 0.03, and 0.00 ± 0.03, respectively. Average analysis time for μQFR was 67 ± 22 s.
Conclusions
Computation of μQFR from a single angiographic view has high feasibility and excellent diagnostic accuracy in identifying hemodynamically significant coronary stenosis. The short analysis time and good reproducibility of μQFR bear potential of wider adoption of physiological assessment in the catheterization laboratory.

© 2021 Wiley Periodicals LLC.

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

12-Month outcomes of transcatheter tricuspid valve repair with the PASCAL system for severe tricuspid regurgitation.

Kitamura M, Fam NP, Braun D, Ruf T, ... von Bardeleben RS, Lurz P
Objectives
We investigated the durability of tricuspid regurgitation (TR) reduction and the clinical outcomes through 12 months after transcatheter tricuspid valve repair (TTVr) with the PASCAL Transcatheter Valve Repair System.
Background
TTVr has rapidly developed and demonstrated favorable acute outcomes, but longer follow-up data are needed.
Methods
Overall, 30 patients (age 77 ± 6 years; 57% female) received PASCAL implantation from September 2017 to May 2019 and completed a clinical follow-up at 12 months.
Results
The TR etiology was functional in 25 patients (83%), degenerative in three (10%), and mixed in two (7%). All patients had TR severe or greater (massive or torrential in 80%) and heart failure symptoms (90% in NYHA III or IV) under optimal medical treatment. Single-leaflet device attachment occurred in two patients. Moderate or less TR was achieved in 23/28 patients (82%) at 30 days, which was sustained at 12 months (86%). Two patients underwent repeat TTVr due to residual torrential TR (day 173) and recurrence of severe TR (day 280), respectively. One-year survival rate was 93%; 6 patients required rehospitalization due to acute heart failure. NYHA functional class I or II was achieved in 90% and 6-minute walk distance improved from 275 ± 122 m at baseline to 347 ± 112 m at 12-month (+72 ± 82 m, p < .01). There was no stroke, endocarditis, or device embolization during the follow-up.
Conclusions
Twelve-month outcomes from this multicenter compassionate use experience with the PASCAL System demonstrated high procedural success, acceptable safety, and significant clinical improvement.

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

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

Complete revascularization in stable multivessel coronary artery disease: A real world analysis from the British Columbia Cardiac Registry.

Iqbal MB, Moore PT, Nadra IJ, Robinson SD, ... Della Siega A, British Columbia Cardiac Registry Investigators
Background
More than half of patients undergoing percutaneous coronary intervention (PCI) have multivessel disease (MVD). The prognostic significance of PCI in stable patients has recently been debated, but little data exists about the potential benefit of complete revascularization (CR) in stable MVD. We investigated the prognostic benefit of CR in patients undergoing PCI for stable disease.
Methods
We compared CR versus incomplete revascularization (IR) in 8,436 patients with MVD. The primary outcome was all-cause mortality at 5 years.
Results
A total of 1,399 patients (17%) underwent CR during the index PCI procedure for stable disease. CR was associated with lower mortality (6.2 vs. 10.7%, p < .001) and lower repeat revascularization at 5 years (12.7 vs. 18.4%, p < .001). Multivariable-adjusted analyses indicated that CR was associated with lower mortality (HR = 0.73, 95% CI: 0.58-0.91, p = .005) and repeat revascularization at 5 years (HR = 0.78, 95% CI: 0.66-0.93, p = .005). These findings were also confirmed in propensity-matched cohorts. Subgroup analyses indicated that CR conferred survival in older patients, male patients, absence of renal disease, greater angina (CCS Class III-IV) and heart failure (NYHA Class III-IV) symptoms, and greater burden of coronary disease. In sensitivity analyses where patients with subsequent repeat revascularization events were excluded, CR remained a strong predictor for lower mortality (HR = 0.69, 95% CI: 0.54-0.89, p = .004).
Conclusions
In this study of stable patients with MVD, CR was an independent predictor of long-term survival. This benefit was specifically seen in higher risk patient groups and indicates that CR may benefit selected stable patients with MVD.

© 2021 Wiley Periodicals LLC.

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

Association of symptom status, myocardial viability, and clinical/anatomic risk on long-term outcomes after chronic total occlusion percutaneous coronary intervention.

Song L, Qiao S, Guan C, Bai Y, ... Kirtane AJ, Xu B
Objectives
This study aimed to examine the association of less-certain indication of chronic total occlusion percutaneous coronary intervention (CTO-PCI) with subsequent clinical outcomes.
Background
The impact of patient symptoms, myocardial viability, and clinical and anatomic risk on long-term outcomes is underdetermined.
Methods
Consecutive patients undergoing CTO-PCI at a large-volume single center between 2010 and 2013 were included. Central adjudication was used to assess the appropriateness of three prespecified indications. The primary outcome was the 5-year composite endpoint of death or myocardial infarction (MI).
Results
Of 2,659 patients with 2,735 CTO lesions, the 348 (13.1%) asymptomatic patients, 164 (6.2%) patients without viable myocardium in the CTO territory, and 306 (11.5%) patients in whom the Synergy between PCI with Taxus and Cardiac Surgery Score II favored coronary artery bypass grafting (CABG) had higher 5-year death or MI compared with the rest patients in each category (12.0% vs. 8.6%, p = .04; 16.3% vs. 8.5%, p < .0001; 12.2% vs. 8.6%, p = .03), respectively. Multivariable regression analysis demonstrated that without symptom (hazard ratio: 1.51; 95% confidence interval: 1.06-2.15; p = .02), non-viable myocardium in CTO territory (hazard ratio: 1.77; 95% confidence interval: 1.16-2.72; p = .009), and deemed more favorable for CABG (hazard ratio:1.54; 95% confidence interval: 1.04-2.28; p = .03), but not the technical success (hazard ratio:0.85; 95% confidence interval: 0.62-1.18; p = .34), were independent predictors for the primary endpoint.
Conclusions
In this large cohort of CTO-PCI, those who were asymptomatic, non-viable myocardium in the CTO territory, or deemed more favorable for CABG were associated with higher risk of long-term mortality or MI.

© 2021 Wiley Periodicals LLC.

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

Atrial flow regulator for drug-resistant pulmonary hypertension in a young child.

Vanhie E, VandeKerckhove K, Haas NA, De Wolf D
This case describes the successful implantation of an Occlutech Atrial Flow Regulator in a young child with idiopathic pulmonary hypertension and recurrent syncope despite targeted combination therapy, with subsequent relief of symptoms.

© 2021 Wiley Periodicals LLC.

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

Comparison of the efficacy and safety of ticagrelor and clopidogrel in patients with acute coronary syndrome after risk stratification.

Li X, Qiu M, Na K, Li Y, ... Li Y, Han Y
Objective
This study aimed at comparing the effectiveness and safety of ticagrelor and clopidogrel in acute coronary artery syndrome (ACS) patients stratified by the Optimal Antiplatelet Therapy for Chinese Patients with Coronary Artery Disease (OPT-CAD) risk score.
Background
Although they provide a promising basis for treatment decisions, risk scores have not been utilized to optimize P2Y12 inhibitors for ACS patients.
Methods
In 2016-2019, 16,343 ACS patients who underwent percutaneous coronary intervention at the General Hospital of Northern Theater Command were enrolled and classified as low-risk (n = 9,841) or intermediate- to high-risk (n = 6,502) according to OPT-CAD risk score. Clinical outcomes for patients receiving clopidogrel or ticagrelor were compared within risk levels. Primary endpoint was ischemic events at 12 months. Propensity score matching (PSM) was used to balance groups.
Results
The risk of ischemic events (2.73% vs. 3.89%, p = .02) and all-cause mortality (1.75% vs. 2.86%, p = .01) were lower in the intermediate- to high-risk patients treated with ticagrelor than those treated with clopidogrel, without an excessive risk of major bleeding (3.71% vs. 3.95%, p = .65). Among low-risk patients, ticagrelor was associated with significantly increased bleeding risk (4.13% vs. 2.85%, p < .01) compared to clopidogrel, with no difference in ischemic risk (1.04% vs. 1.25%, p = .36). Results were consistent in PSM cohorts.
Conclusions
Ticagrelor improves ischemic prognosis in intermediate- to high-risk patients but shows worse safety in low-risk patients compared to clopidogrel, supporting the effectiveness of risk score-guided decision making.

© 2021 Wiley Periodicals LLC.

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

Randomized trial comparing radial hemostasis techniques; catechol conjugated chitosan pad (InnoSEAL) versus pneumatic compression band.

Pathan AZ, Aijaz S, Sheikh S, Sattar S
Objectives
Primary objectives: to compare radial artery occlusion rate (RAO) after cardiac catheterization between catecholamine-chitosan pad (InnoSEAL) and pneumatic compression device (PCD) and to compare difference in hemostasis time and radial monitoring termination time between two arms. Secondary objectives: to compare radial site bleeding and ease of use of two methods by cath-lab technicians.
Background
Hemostatic pads may be an effective alternative to PCD with lesser chance of access site complications with advantage of shortened compression time.
Methods
Patients (N = 606) undergoing trans-radial, diagnostic or interventional procedures were randomized to either InnoSEAL arm or PCD. RAO was assessed using US Duplex; performed 6-24 hr posthemostatic device removal. Time to hemostasis was recorded as per defined protocols. Ease of use among cath-lab technicians was assessed through 5 point Likert scale.
Results
Data of 597 patients was analyzed (299 InnoSEAL, 298 PCD). RAO rate was 8.5% in InnoSEAL and 9.4% in PCD arm (p value >.05). The pooled median hemostasis time and time to termination of radial monitoring was 42 versus 225 min and 50 versus 240 min in InnoSEAL and PCD arms, respectively (p value: <.01). There was no difference in Grade I/II hematoma (InnoSEAL: 1.3% vs. PCD: 3.4%). InnoSEAL was marginally acceptable compared to PCD by technicians.
Conclusion
Hemostasis time is significantly shorter in InnoSEAL arm with reasonable acceptability to its usage among cath lab staff. RAO and bleeding complications are comparable between the arms. Based on our findings, it seems feasible to include Chitosan based hemostasis pad routinely in cath lab.

© 2021 Wiley Periodicals LLC.

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

Clinical outcomes of percutaneous debulking of tricuspid valve endocarditis in intravenous drug users.

Akhtar YN, Walker WA, Shakur U, Smith G, Husnain SS, Adigun SF
Objectives
A retrospective case series of a percutaneous approach to debulk tricuspid valve endocarditis (TVE) using an 8 French mechanical aspiration system in patients with a history of intravenous drug use (IVDU) was reported. IVDU associated TVE is increasing in the United States and is associated with high mortality despite early surgical debridement. Patients with advanced disease, shock, and respiratory failure may not be candidates for surgical debridement or replacement. These patients have recurrent events despite medical therapy
Methods:
About 25 patients with IVDU associated TVE with persistent bacteremia confirmed by repeat blood cultures after 72 hr of sensitivity directed antibiotics and presence of pulmonary emboli confirmed by computed tomographic (CT) scan, who had undergone percutaneous aspiration were included. Patients were all deemed high risk for surgical debridement by a CT surgeon and evaluated by an infectious disease consultant. Procedures were performed under moderate sedation with intracardiac echo and a steerable guide with a CAT8 Penumbra aspiration catheter.
Results
There were no intraprocedural deaths or complications. About 36% had septic shock on presentation. Survival of index hospitalization was 88%. Repeat blood cultures showed no growth on all surviving patients. Readmission rate was 4% (n = 1) at 1 month. About 40% (n = 2) patients with septic shock survived at 1 month compared with 100% survival (n = 20) in those without shock. Presence of septic shock was associated with reduced survival at 1 month (p < .01).
Conclusion
Percutaneous mechanical aspiration with an 8 Fr system is a feasible, minimally invasive alternative to surgical debulking. Mortality remains high in those presenting with septic shock. Further studies are needed to evaluate long-term outcomes.

© 2021 Wiley Periodicals LLC.

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

Impact of 6- versus 12-month dual antiplatelet therapy on clinical prognosis in patients with high bleeding risk: Insights from the 4-year results of the I LOVE IT 2 study.

Zhang J, Qiu M, Na K, Ma S, ... Li Y, Han Y
Objectives
To explore the impact of 6- versus 12-month dual antiplatelet therapy (DAPT) on the clinical prognosis of high bleeding risk (HBR) patients.
Background
The optimal DAPT duration after percutaneous coronary intervention (PCI) in HBR patients is unclear.
Methods
This study is a post hoc analysis of the 4-year clinical follow-up results of the I LOVE IT 2 study. Prevalence and prognosis of HBR patients were explored, and clinical outcomes of HBR patients who underwent 6- versus 12-month DAPT were compared. The primary outcome was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding. The secondary outcomes were BARC type 2-5 bleeding and net clinical adverse events (NACE), defined as a composite of all-cause death, myocardial infarction (MI), ischemia-driven revascularization, stroke, stent thrombosis, or any bleeding events.
Results
HBR occurred in 440 of 2,737 patients (16.0%). HBR patients were associated with a higher risk of BARC type 3 or 5 bleeding (2.95 vs. 1.52%, p = .03), NACE (31.82 vs. 25.99%, p = .01), all-cause death (5.68 vs. 3.13%, p = .008) and stroke (9.09 vs. 3.83%, p < .001) than non-HBR patients at 4 years. There were no significant differences in BARC type 3 or 5 bleeding (3.07 vs. 2.76%, p = 1.00) or NACE rate (31.9 vs. 33.8%, p = .72) between patients who underwent 6- and 12-month DAPT.
Conclusions
HBR patients are at a higher risk of long-term bleeding and ischemic events than non-HBR patients. The safety and efficacy of 6- and 12-month DAPT were comparable in HBR patients.

© 2021 Wiley Periodicals LLC.

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

Three-dimensional cardiac print assisted percutaneous closure of left ventricular pseudoaneurysm in patient with Behçet\'s disease.

Quimby DL, Ford J, Tanner GJ, Mencer N, Decker S, Matar F
Spontaneous left ventricular pseudoaneurysms are very rare and can have catastrophic consequences if unrecognized. A case of combined spontaneous left ventricular aneurysm and pseudoaneurysm in Behcet\'s disease (BD) has been reported. The case emphasizes advanced techniques for percutaneous closure of the defects with the use of an ex-vivo three-dimensional cardiac printed model as a tool to facilitate the procedure.

© 2021 Wiley Periodicals LLC.

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

Transcatheter aortic valve thrombosis: Data from a French multicenter cohort analysis.

Mouyen T, Manigold T, Collet JP, Durand E, ... Combaret N, Souteyrand G
Objectives
To evaluate the effectiveness of anticoagulant therapies in patients with clinical transcatheter heart valve (THV) thrombosis, to describe complications, and to assess their risk profile was the objectives.
Background
Little research has been conducted on clinical THV thrombosis.
Methods
Patients with clinical THV thrombosis were identified based on greater than 50% increased transvalvular gradient on transthoracic echocardiogram confirmed by 4-dimensional computed tomography, transesophageal echocardiogram, or regression with anticoagulant therapy. A cohort free from thrombosis for more than 1,100 days postprocedure was used for comparison.
Results
Fifty-four patients with clinical THV thrombosis were identified. Most subjects (98.1%) received anticoagulant therapy which was effective (≥50% reduction in transvalvular gradient or return to postprocedure value) in 96%. The rate of serious hemodynamic or embolic complications in the thrombosis population was 31.5%. A multivariate analysis of subjects with and without thrombosis indicated a significantly increased risk of thrombosis from preexisting thrombocytopenia (odds ratio [OR] 9.96), absence of predilatation (OR = 5.67), renal insufficiency (OR = 4.84), and >10 mmHg mean transvalvular gradient postprocedure (OR = 3.36). No recurrence of thrombosis was identified during on average 685 days follow-up.
Conclusions
These data, from one of the largest cohorts with clinical THV thrombosis confirm anticoagulants appear effective. The rate of serious associated complications was high. The findings underline the importance of recognizing risk factors for thrombosis.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 20 Feb 2021; epub ahead of print

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

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

© 2021 Wiley Periodicals LLC.

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

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

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

© 2021 Wiley Periodicals LLC.

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

Use of MitraClip for mitral valve repair in patients with acute mitral regurgitation following acute myocardial infarction: Effect of cardiogenic shock on outcomes (IREMMI Registry).

Estévez-Loureiro R, Shuvy M, Taramasso M, Benito-Gonzalez T, ... Fernández-Vázquez F, Maisano F
Objectives
To assess outcomes in patients with acute mitral regurgitation (MR) following acute myocardial infarction (AMI) who received percutaneous mitral valve repair (PMVR) with the MitraClip device and to compare outcomes of patients who developed cardiogenic shock (CS) to those who did not (non-CS).
Background
Acute MR after AMI may lead to CS and is associated with high mortality.
Methods
This registry analyzed patients with MR after AMI who were treated with MitraClip at 18 centers within eight countries between January 2016 and February 2020. Patients were stratified into CS and non-CS groups. Primary outcomes were mortality and rehospitalization due to heart failure. Secondary outcomes were acute procedural success, functional improvement, and MR reduction. Multivariable Cox regression analysis evaluated association of CS with clinical outcomes.
Results
Among 93 patients analyzed (age 70.3 ± 10.2 years), 50 patients (53.8%) experienced CS before PMVR. Mortality at 30 days (10% CS vs. 2.3% non-CS; p = .212) did not differ between groups. After median follow-up of 7 months (IQR 2.5-17 months), the combined event mortality/re-hospitalization was similar (28% CS vs. 25.6% non-CS; p = .793). Likewise, immediate procedural success (90% CS vs. 93% non-CS; p = .793) and need for reintervention (CS 6% vs. non-CS 2.3%, p = .621) or re-admission due to HF (CS 13% vs. NCS 23%, p = .253) at 3 months did not differ. CS was not independently associated with the combined end-point (hazard ratio 1.1; 95% CI, 0.3-4.6; p = .889).
Conclusions
Patients found to have significant MR during their index hospitalization for AMI had similar clinical outcomes with PMVR whether they presented in or out of cardiogenic shock, provided initial hemodynamic stabilization was first achieved before PMVR.

© 2021 Wiley Periodicals LLC.

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

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

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

© 2021 Wiley Periodicals LLC.

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

Interventional closure of aortomitral perforation after TAVR: A case report.

Petri N, Lengenfelder B, Voelker W, Nordbeck P
Despite TAVR emerging as the gold standard for a broad spectrum of patients, it is associated with serious complications. In this report we present a case, where a TAVR procedure led to a perforation at the aortomitral continuity, discuss the risk factors for the occurrence of perforations and how we decided to treat the patient.

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

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

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

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

© 2021 Wiley Periodicals LLC.

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

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

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

© 2021 Wiley Periodicals LLC.

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

CoreValve bioprosthesis dysfunction treated with a Sapien 3 valve-in-valve transcatheter aortic valve replacement and BASILICA technique.

Sharma RK, Tuttle MK, Poulin MF, Laham RJ
Structural deterioration of transcatheter heart valve (THV) has been previously described. With the expansion of transcatheter aortic valve replacement (TAVR) indications toward treating lower risk patients with longer life expectancy, there will be increased necessity of managing the patients with THV dysfunction including those at risk for coronary obstruction or sinus sequestration. Coronary access also remains a challenge in such cases with THV dysfunction undergoing valve-in-transcatheter heart valve (ViTHV) TAVR. A unique and first reported case of THV deterioration treated with Sapien 3 ViTHV-TAVR inside a 31 mm CoreValve bioprosthesis along with left coronary leaflet laceration using the BASILICA technique has been presented.

© 2021 Wiley Periodicals LLC.

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

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

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

© 2021 Wiley Periodicals LLC.

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

Cerebral protection in left atrial appendage closure in the presence of appendage thrombosis.

Boccuzzi GG, Montabone A, D\'Ascenzo F, Colombo F, ... Meincke F, Mazzone P
Background
Presence of thrombus in the left atrial appendage (LAA) remains a severe contraindication to the percutaneous left atrial appendage closure procedure (LAAC), due to increased embolic risk. Recently, the experience developed in cerebral protection device in transcatheter aortic valve implantation (TAVI) procedure was translated in LAAC to address this issue.
Aim
To evaluate efficacy and safety of Sentinel cerebral protection system (CPS) in supporting LAAC in real-world patient with persistent LAA thrombus.
Methods and results
The study retrospectively enrolled consecutive patients with non-valvular atrial fibrillation (NVAF) and thrombus in LAA who underwent LAAC supported by Sentinel CPS in seven European high-volume centres. Twenty-seven patients were included with a median age of 69.1 ± 9.7 years old, with median CHA₂ DS₂ -VASc and HAS-BLEED scores 3 [2-5] and 3 [2.75-4], respectively. Technical and procedural success was achieved in all patients. No periprocedural TIA, stroke, or supra-aortic trunks dissection was recorded.
Conclusions
In this multicenter registry, LAAC supported by Sentinel CPS in patients with LAA persistent thrombus seems to be a safe and efficacious treatment.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Feb 2021; 97:511-515

Ten year follow-up of high-risk patients treated during the early experience with transcatheter aortic valve replacement.

Sathananthan J, Lauck S, Polderman J, Yu M, ... Wood DA, Webb JG
Background
The long-term clinical performance of transcatheter heart valves (THV) is unknown.
Aims
This study assessed the clinical outcomes, rate of structural valve deterioration (SVD) and bioprosthetic valve failure in patients after transcatheter aortic valve replacement (TAVR) to 10-year follow-up.
Methods
Consecutive patients undergoing TAVI for native aortic valve stenosis or failed aortic surgical bioprosthesis, between 2005 and 2009 at our institution were included. A total of 235 consecutive patients.
Results
At the time of TAVI mean age was 82.4 ± 7.9 years. All patients were judged to be high risk, with a STS score > 8 in 53.6%. THVs implanted were the Cribier-Edwards (20.9%), Edwards SAPIEN (77.4%) or CoreValve (1.7%). Mortality at 1, 5, and 10-year follow-up was 23.4%, 63%, and 91.6%, respectively. Of the total cohort, 15 patients had structural valve deterioration/bioprosthetic valve failure, with a cumulative incidence at 10-years of 6.5% (95% CI 3.3%, 9.6%). The rate of SVD/BVF at 4, 6, 8, and 10 years was 0.4%, 1.7%, 4.7%, and 6.5%, respectively. Nine patients had moderate SVD and six patients had severe SVD. Of the six patients with severe SVD, two patients had reintervention (one patient had redo TAVR, and the second had surgical aortic valve replacement). Survivors (n = 19) at 10-year follow-up, had a mean gradient of 14.0 ± 7.6 mmHg and aortic regurgitation ≥moderate in 5%. Quality of life measures in 10-year survivors demonstrated ADLs 6/6 in 43.8%, and ambulation without a mobility aid of 62.5%.
Conclusion
Using early generation balloon expandable THVs in a high-risk population, there was a low rate of structural valve deterioration and valve failure at 10-year follow-up. This study provides insights into the long-term performance of transcatheter heart valves and patients self-reported derived benefits.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Feb 2021; 97:E431-E437

Short-term outcomes of transcatheter aortic valve replacement for pure native aortic regurgitation in the United States.

Isogai T, Saad AM, Ahuja KR, Shekhar S, ... Krishnaswamy A, Kapadia SR
Objective
We aimed to compare short-term outcomes between transcatheter aortic valve replacement (TAVR) for pure aortic regurgitation (AR) and TAVR for aortic stenosis (AS).
Background
In patients with severe pure AR for whom surgical valve replacement is infeasible, TAVR is sometimes used off-label.
Methods
Using the Nationwide Readmissions Database 2016-2017, we retrospectively identified patients without prior valve surgery who underwent endovascular TAVR. We compared in-hospital and 30-day outcomes according to the type of aortic valve disease.
Results
A total of 81,542 eligible patients were divided into the pure AR (n = 1,222, 1.50%), pure AS (n = 72,690, 89.1%), and AS + AR (n = 7,630, 9.36%) groups. In unadjusted analyses, the pure AR group, compared with the pure AS and AS + AR groups, showed a higher incidence of acute kidney injury (16.8% vs. 9.8% vs. 12.1%, respectively; p < .001) and need of surgical bailout (1.4% vs. 0.4% vs. 0.6%; p < .01). The pure AR group also showed higher in-hospital mortality than the pure AS group (2.4% vs. 1.4%; p = .005). After multivariable adjustment, TAVR for pure AR was significantly associated with a higher risk of acute kidney injury (odds ratio [OR] = 1.64, 95% confidence interval [CI] = 1.33-2.02; p < .001), cardiac tamponade (OR = 1.98, 95% CI = 1.00-3.92; p = .0498), and prolonged hospital stay (OR = 1.59, 95% CI = 1.29-1.95; p < .001) compared with TAVR for pure AS, whereas it was not significantly associated with in-hospital mortality (OR = 1.55, 95% CI = 0.99-2.45; p = .058) and other outcomes.
Conclusions
TAVR may be a reasonable treatment option for selected patients with pure AR with regard to short-term outcomes. However, additional techniques or devices may be necessary to reduce periprocedural risk.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Feb 2021; 97:477-485

Impact of thoracic aortic aneurysm on outcomes of transcatheter aortic valve replacement: A nationwide cohort analysis.

Kassis N, Saad AM, Ahuja KR, Gad MM, ... Unai S, Kapadia SR
Background
The use of transcatheter aortic valve replacement (TAVR) has expanded to patient populations of varying surgical risk in light of recent clinical trials, yet its role in patients with aortic stenosis and coexisting thoracic aortic aneurysm (TAA) is not well-delineated. We aimed to evaluate whether risk factors and in-hospital outcomes vary between TAVR patients with and without an unruptured TAA.
Methods
The Nationwide Readmissions Database was queried for patients hospitalized between January 2012 and December 2017 who underwent TAVR with and without an unruptured TAA. In-hospital outcomes were compared between cohorts after adjusting for sex, comorbidities, and TAVR approach, and in a subgroup analysis that excluded those with bicuspid aortic valves.
Results
Among 171,011 TAVR patients, 1,677 (1%) presented with TAA. Patients with TAA were younger (median age 80 vs. 82 years, p < .001) and more likely to have bicuspid aortic valves (9.3% vs. 0.9%, p < .001). Among patients with aneurysm, 2.6% died, 2.2% developed stroke, 1% developed aortic dissection, and 1.4% experienced cardiac tamponade while hospitalized. After adjusting for age, sex, bicuspid aortic valve, and all comorbidities, TAA was associated with significantly higher risk of post-TAVR aortic dissection (OR = 2.117, 95% CI [1.304-3.435], p = .002) and cardiac tamponade (OR = 1.682, 95% CI [1.1-2.572], p = .02).
Conclusions
While the overall incidence of post-TAVR complications is low, patients with an unruptured TAA should be carefully considered by the Heart Team in weighing the additional risks of aortic dissection and cardiac tamponade after TAVR with those associated with surgery.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Feb 2021; 97:549-553

Reverse remodeling after percutaneous transluminal septal myocardial ablation in severe but asymptomatic LVOT obstruction (RASTA) study: Rationale and design of transcatheter septal reduction in asymptomatic patients with severe hypertrophic obstructive cardiomyopathy.

Arslan F, Akdim F, Ten Berg JM
Objectives
The aim of this study is to evaluate the impact of percutaneous transluminal septal myocardial ablation (PTSMA) on remodeling in asymptomatic patients with hypertrophic obstructive cardiomyopathy (HOCM) and severe left ventricular outflow tract (LVOT) obstruction.
Background
Symptoms justify invasive treatment in HOCM patients with LVOT obstruction. Adverse structural and functional changes (remodeling) in the heart occur preceding heart failure and sudden cardiac death. Early invasive treatment in asymptomatic patients may reverse adverse remodeling to the same extent as in symptomatic patients.
Methods
Reverse remodeling after PTSMA in severe but asymptomatic LVOT obstruction (RASTA) study is a prospective single-blind randomized trial (ClinicalTrials.gov number: NCT04230551). Ten asymptomatic HOCM patients with an exertional LVOT gradient ≥50 mmHg (or >30 mmHg in rest) are randomized 1:1 to PTSMA versus conservative therapy, in the absence of mitral valve disease or other indications for cardiac surgery. Five symptomatic (reference group) will undergo PTSMA according to the current guidelines.
Results
Remodeling is assessed using extensive cardiac imaging with transthoracic echocardiography and late gadolinium enhancement cardiac magnetic resonance at baseline and during follow-up at 1, 12, and 24 months. Extracellular volume fraction, global, and regional strain analysis, geometry, pressure gradients and changes in four-dimensional velocity mapping are primary parameters to study (reversal of) adverse remodeling.
Conclusions
The RASTA study gives insight in cardiac remodeling that may occur in asymptomatic patients after PTSMA. It will provide arguments whether to pursue (or not) a larger trial with clinical endpoints in asymptomatic HOCM patients with severe LVOT obstruction.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Feb 2021; 97:488-492

Adverse clinical outcomes in patients undergoing both PCI and TAVR: Analysis from a pooled multi-center registry.

Kumar A, Sammour Y, Reginauld S, Sato K, ... Kapadia S, Samady H
Background
There is a paucity of data regarding the optimum timing of PCI in relation to TAVR.
Objective
We compared the major adverse cardiovascular and cerebrovascular events (MACCE) rates among patients who underwent percutaneous coronary intervention (PCI) before transcatheter aortic valve replacement (TAVR) with those who received PCI with/after TAVR.
Methods
In this multicenter study, we pooled all consecutive patients who underwent TAVR at three high volume centers.
Results
Among 3,982 patients who underwent TAVR, 327 (8%) patients underwent PCI within 1 year before TAVR, 38 (1%) had PCI the same day as TAVR and 15 (0.5%) had PCI within 2 months after TAVR. Overall, among patients who received both PCI and TAVR (n = 380), history of previous CABG (HR:0.501; p = .001), higher BMI at TAVR (HR:0.970; p = .038), and statin therapy after TAVR (HR:0.660, p = .037) were independently associated with lower MACCE while warfarin therapy after TAVR was associated with a higher risk of MACCE (HR:1.779, p = .017). Patients who received PCI within 1 year before TAVR had similar baseline demographics, STS scores, clinical risk factors when compared to patients receiving PCI with/after TAVR. Both groups were similar in PCI (Syntax Score, ACC/AHA lesion class) and TAVR (valve types, access) related variables. There were no significant differences in terms of MACCE (log rank p = .550), all-cause mortality (log rank p = .433), strokes (log rank p = .153), and repeat PCI (log rank p = .054) in patients who underwent PCI with/after TAVR when compared to patients who received PCI before TAVR.
Conclusion
Among patients who underwent both PCI and TAVR, history of CABG, higher BMI, and statin therapy had lower, while those discharged on warfarin, had higher adverse event rates. Adverse events rates were similar regardless of timing of PCI.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Feb 2021; 97:529-539

Prevalence, predictors, and outcomes of patient prosthesis mismatch in women undergoing TAVI for severe aortic stenosis: Insights from the WIN-TAVI registry.

Panoulas VF, Chandrasekhar J, Busi G, Ruparelia N, ... Mikhail GW, WIN-TAVI Investigators
Objective
To evaluate the incidence, predictors and outcomes of female patients with patient-prosthesis mismatch (PPM) following transcatheter aortic valve intervention (TAVI) for severe aortic stenosis (AS).
Background
Female AS TAVI recipients have a significantly lower mortality than surgical aortic valve replacement (SAVR) recipients, which could be attributed to the potentially lower PPM rates. TAVI has been associated with lower rates of PPM compared to SAVR. PPM in females post TAVI has not been investigated to date.
Methods
The WIN-TAVI (Women\'s INternational Transcatheter Aortic Valve Implantation) registry is a multicenter registry of women undergoing TAVR for severe symptomatic AS. Two hundred and fifty patients with detailed periprocedural and follow-up echocardiographic investigations were included in the WIN-TAVI echocardiographic sub-study. PPM was defined as per European guidelines stratified by the presence of obesity.
Results
The incidence of PPM in our population was 32.8%. Patients with PPM had significantly higher BMI (27.4 ± 6.1 vs. 25.2 ± 5.0, p = .002), smaller sized valves implanted (percentage of TAVI ≤23 mm 61% vs. 29.2%, PPM vs. no PPM, p < .001) and were more often treated with balloon expandable valves (48.3 vs. 32.5%, p < .001) rather than self expanding ones (26.3 vs. 52.8%, <.001). BMI (OR = 1.08; 95%CI 1.02-1.14, p = .011) and valve size ≤23 mm (OR = 3.00 95%CI 1.14-7.94, p = .027) were the only independent predictors of PPM. There was no significant interaction between valve size and valve type (p = .203). No significant differences were observed in 1-year mortality or major adverse cardiovascular events.
Conclusions
PPM in females undergoing TAVI occurs in one third of patients. BMI and valve size ≤23 mm are independent predictors. Larger registries are required to determine the impact of PPM on future clinical outcomes.

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

Catheter Cardiovasc Interv: 14 Feb 2021; 97:516-526

Comparison of clinical results between percutaneous closure and surgical repair of ruptured sinus of Valsalva aneurysm.

Yang K, Luo X, Tang Y, Hu H, Sun H
Objectives
This study was conducted to investigate whether percutaneous closure of ruptured sinus of Valsalva aneurysm (SVA) is as safe and effective as surgery repair.
Background
Percutaneous closure of ruptured SVA has been becoming an alternative to the traditional surgical repair recently. The reports regarding direct comparison of these two treatment options are scarce.
Methods
The medical records from the institutional database were retrospectively analyzed. A total of 134 patients were reviewed, including 26 patients undergoing percutaneous closure and 108 patients being treated surgically. To reduce the potential bias, 32 patients from Surgical Repair group were selected by propensity score matching.
Results
All the ruptured SVAs were successfully closed in each group. No severe procedure-related complications were found in the perioperative period. After matching, there were no significant differences in the baseline clinical characteristics. The median postoperative hospital stays of Matched group were significantly longer than that of Percutaneous Closure group (7 days vs. 1 day, p < .001). Aortic regurgitation, residual shunt and recurrence of SVAs were common complications in both Percutaneous Closure group and Surgical Repair group.
Conclusions
The appropriately selected patients with ruptured SVA could be treated by percutaneous closure with an acceptable risk of short-term complications. Though surgical repair remains the main treatment option for ruptured SVAs, percutaneous closure could be considered in patients with a small-size rupture and no associated cardiac abnormalities.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Feb 2021; 97:E354-E361

Transcaval access for the emergency delivery of 5.0 liters per minute mechanical circulatory support in cardiogenic shock.

Afana M, Altawil M, Basir M, Alqarqaz M, ... Lederman RJ, Greenbaum AB
Objectives
The purpose of this study was to describe the feasibility and early outcomes of transcaval access for delivery of emergency mechanical circulatory support (MCS) in cardiogenic shock.
Background
Vascular access for implantation of MCS in patients with cardiogenic shock is often challenging due to peripheral arterial disease and vasoconstriction. Transcaval delivery of MCS may be an alternative. We describe a series of patients we implanted an Impella 5.0 device, on-table without CT planning, through a percutaneous transcaval access route.
Methods
Ten patients with progressive or refractory cardiogenic shock underwent Impella 5.0 implantation via transcaval access. Demographic, clinical and procedural variables and in-hospital outcomes were collected.
Results
All ten underwent emergency implantation of the 7 mm diameter Impella 5.0 device via transcaval access. Six were women, with median age of 55.5 years (range, 29-69). Cardiogenic shock was attributed to idiopathic nonischemic cardiomyopathy (n = 4), myocarditis (n = 2), ischemic cardiomyopathy (n = 2), heart transplant rejection (n = 1), and unknown etiology (n = 1). Median duration of support was 92.1 hr (range, 21.2-165.4). Seven (70%) survived to device explant, with six (60%) surviving to access port closure and discharge. Among survivors, five recovered heart function and one received destination therapy left ventricular assist device.
Conclusions
Transcaval access is feasible for emergency nonsurgical implantation of the Impella 5.0 device in cardiogenic shock with small or diseased iliofemoral arteries. This allows early institution of higher-flow MCS than conventional femoral artery implantation of the 3.5 L Impella CP device, and enables a bridge-to-recovery or bridge-to-destination strategy.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Feb 2021; 97:555-564

Percutaneous mitral valve repair in adults with congenital heart disease: Report of the first case-series.

Alshawabkeh L, Mahmud E, Reeves R
Background
Systemic atrioventricular valve regurgitation (AVVR) is frequently encountered in adults with congenital heart disease (CHD). Surgical intervention is the mainstay of therapy, but in a specific high-risk subset, percutaneous valve repair might offer a lower-risk alternative.
Methods
Three patients with complex CHD and severe symptomatic AVVR underwent percutaneous mitral valve repair at a single center. All were deemed to be high-risk for surgery by a multidisciplinary CHD team and provided informed consent for the compassionate use of the MitraClip (Abbott, Santa Clara, CA). Three-dimensional heart models were generated for the procedure, which was performed by an adult CHD cardiologist (who provided imaging support) and an interventional cardiologist with expertise in CHD and percutaneous mitral valve repair.
Results
The first case was a 39 year-old-woman with [S,L,D] dextrocardia, double outlet right ventricle, mild tricuspid hypoplasia, and a secundum atrial septal defect, who was palliated at age 35 with a right bidirectional Glenn and later developed severe, symptomatic mitral regurgitation, and underwent placement of one MitraClip XT_R device. Two patients with L-loop transposition of the great arteries each successfully underwent placement of two MitraClip XT_R devices; one patient had a single-leaflet detachment of one of the clips with no change in regurgitation or clip position on follow-up. All patients had significant reduction of AVVR and improvement in NYHA functional class.
Conclusions
Percutaneous atrioventricular valve repair in adults with CHD is feasible with the MitraClip but requires significant preprocedural planning and a multidisciplinary team that combines CHD and interventional therapeutic expertise.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Feb 2021; 97:542-548

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

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

© 2020 Wiley Periodicals LLC.

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

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

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

© 2020 Wiley Periodicals LLC.

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

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

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

© 2020 Wiley Periodicals LLC.

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

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

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

© 2020 Wiley Periodicals LLC.

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

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

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

© 2020 Wiley Periodicals LLC.

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

Mechanical properties of low-diameter balloon expandable covered stents.

Blais B, Carr K, Sinha SP, Salem MM, Levi DS
Objectives
To determine over-dilation potential of commercially available covered stents.
Background
Covered stents including the Atrium iCast, Gore VBX, and Lifestream stents (LS) can treat ruptures, dissections, and aneurysms in small vessels. Especially in growing patients, stents often require serial dilations beyond their implant or nominal diameters. Tolerance of serial dilations is clinically important information for interventionalists.
Methods
Serial dilations of 5-12 mm iCast, VBX, and LS covered stents were performed in 1-2 mm increments (up to 20 mm). With each dilation, foreshortening and recoil were measured, and stent strut and covering integrity were assessed. High-pressure balloons were used to expand the stents until they fractured or could not be further expanded.
Results
The 5-8 mm LS tolerated dilation to 14.5-16 mm. The 10-12 mm LS stents tolerated dilation to 18 mm and fractured on the 20 mm balloon. LS stents foreshortened 35%-45% on average after 8 mm of over-dilation and had 5%-10% recoil on <6 mm over-dilation. All iCast stents tolerated dilation to 12-13 mm and required fracture for dilation to >14 mm. ICast stents foreshortened 19%-29% at maximum dilation, with 3-6% recoil on <2 mm over-dilation, and < 3% thereafter. VBX stents over-dilated to 2.9-4.7 mm above nominal, foreshortening 40%-50% after 4-6 mm of over-dilation before collapsing into a ring. VBX stent recoil was <2.5% on all dilations.
Conclusions
LS stents had the greatest over-dilation potential. VBX stents had the least recoil but tended to foreshorten significantly 3-4 mm above nominal. Regardless of nominal size, all iCast stents (including the 5 mm) tolerated dilation to a maximum of 12-13 mm.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Feb 2021; 97:451-458

An interventional approach to left ventricular assist device outflow graft obstruction.

Gertz ZM, Trankle CR, Grizzard JD, Quader MA, ... Parris KE, Shah KB
Background
LVADs provide life-sustaining treatment for patients with heart failure, but their complexity allows for complications. One complication, LVAD outflow graft obstruction, may be misdiagnosed as intraluminal thrombus, when more often it is extraluminal compression from biodebris accumulation. It can often be treated endovascularly with stenting. This case series describes diagnostic and procedural techniques for the treatment of left ventricular assist device (LVAD) outflow graft obstruction.
Methods
We present four patients with LVADs who developed LVAD outflow graft obstruction within the bend relief-covered segment. All were initially diagnosed with computed tomographic angiography (CTA). All underwent invasive evaluation with intravascular ultrasound (IVUS), then were treated with stenting. After misdiagnosing a twist, we developed the technique of balloon \"graftoplasty\" to ensure suitability for stent delivery in subsequent cases.
Results
All patients presented with low-flow alarms and symptoms of low output, and were diagnosed with outflow graft obstruction by CTA. In all four, IVUS confirmed an extraluminal etiology. Patient 1 was treated with stenting and had a good outcome. Patient 2\'s obstruction was from twisting, rather than biodebris accumulation, and had sub-optimal stent expansion and ultimately required surgery. Balloon \"graftoplasty\" was used in subsequent cases to ensure subsequent stent expansion. Patients 3 and 4 were successfully stented. All improved after treatment.
Conclusions
In patients with LVAD outflow graft obstruction, IVUS can distinguish intraluminal thrombus from extraluminal compression. Balloon \"graftoplasty\" can ensure that the outflow graft will respond to stenting. Many cases of LVAD outflow graft obstruction should be amenable to endovascular treatment.

© 2021 Wiley Periodicals LLC.

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

Coronary angiography-derived contrast fractional flow reserve.

Gong Y, Zheng B, Yi T, Yang F, ... Li J, Huo Y
Background
Based on coronary angiography and mean aortic pressure, a specially designed computational flow dynamics (CFD) method is proposed to determine contrast fractional flow reserve (cFFR) without using invasive pressure wire. This substudy assessed diagnostic performance of coronary angiography-derived cFFR in catheterization laboratory, based on a previous multicenter trial for online assessment of coronary angiography-derived FFR (caFFR).
Methods
Patients with diagnosis of stable angina pectoris or unstable angina pectoris were enrolled in six centers. Wire-based FFR was measured in coronary arteries with 30-90% diameter stenosis. Offline angiography-derived cFFR was computed in blinded fashion against the wire-based FFR and caFFR at an independent core laboratory.
Results
A total of 330 patients were enrolled to fulfill inclusion/exclusion criteria from June 26 to December 18, 2018. Offline angiography-derived cFFR and wire-based FFR results were compared in 328 interrogated vessels. The statistical analysis showed the highest diagnostic accuracy of 89.0 and 86.6% for angiography-derived cFFR with a cutoff value of 0.94 and 0.93 against the wire-based FFR with a cutoff value of 0.80 and 0.75, respectively. The corresponding sensitivity and specificity were 92.2 and 87.3% for the cutoff value of 0.94 and 80.0 and 88.4% for the cutoff value of 0.93, which are similar to those against the caFFR. The receiver-operating curve has area under the curve of 0.951 and 0.972 for the wire-based FFR with the cutoff value of 0.80 and 0.75, respectively.
Conclusions
Coronary angiography-derived cFFR showed higher accuracy, sensitivity, and specificity against wired-based FFR and caFFR. Hence, angiography-derived cFFR could enhance the hemodynamic assessment of coronary lesions.

© 2021 Wiley Periodicals LLC.

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

Computed tomography analysis of coronary ostia location following valve-in-valve transcatheter aortic valve replacement with the ACURATE neo valve: Implications for coronary access.

Khokhar AA, Laricchia A, Ponticelli F, Kim WK, ... Colombo A, Giannini F
Background
Valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) is an emerging alternative to re-do surgery. However, the challenge of coronary access (CA) following ViV-TAVR is a potential limitation as TAVR expands to younger lower-risk populations.
Objectives
Using post-implantation computed tomography (CT) scans to evaluate the geometrical relationship between coronary ostia and valve frame in patients undergoing ViV-TAVR with the ACURATE neo valve.
Methods
Post-implant CT scans of 18 out of 20 consecutive patients treated with the ACURATE neo valve were analyzed. Coronary ostia location in relation to the highest plane (HP) (highest point of the ACURATE neo or surgical valve) was determined. Ostia located below the highest plan were further subclassified according to the gap available between the transcatheter heart valve frame and ostium (transcatheter-to-coronary [TTC] distance). The impact implantation depth has on these geometrical relationships was evaluated.
Results
A total of 21 out of 36 coronary ostia (58%) were located below the level of the HP with the left coronary artery (36%) more likely to be affected than the right (22%). Further sub-classification of these ostia revealed a large (>6 mm), moderate (4-6 mm), and small (<4 mm) TTC distance in 57% (12/21), 38% (8/21), and in 6% (1/18) of cases, respectively. At an implantation depth <4 mm compared to >4 mm, all ostia were located below the HP with no difference in post-procedural mean gradients (14.5 mmHg ± 4.7 vs. 12.6 mmHg ± 5.8; p = .5, 95%CI 3.8-7.5).
Conclusions
CA following ACURATE neo implantation for ViV-TAVR could potentially be challenging in a significant proportion of patients and specific consideration should be given to the implantation depth.

© 2021 Wiley Periodicals LLC.

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

Left atrial appendage occlusion in chicken-wing anatomies: Imaging assessment, procedural, and clinical outcomes of the \"sandwich technique\".

Freixa X, Tzikas A, Aminian A, Flores-Umanzor E, ... Ibrahim R, Nielsen-Kudsk JE
Objectives
To describe imaging assessment, procedural and follow-up outcome of patients undergoing left atrial appendage (LAA) occlusion (LAAO) using a \"sandwich\" technique.
Background
The presence of a LAA with chicken wing morphology constitutes a challenge that sometimes requires specific occlusion strategies like the \"sandwich\" technique. However, procedural and follow-up data focusing on this implanting strategy is scarce.
Methods
This multicenter study collected individual data from eight centers between 2012 and 2019. Consecutive patients with chicken-wing LAAs defined as an early (<20 mm from the ostium) and severe bend (>90°) who underwent LAAO with Amplatzer devices and using the \"sandwich\" technique were included in the analysis.
Results
Overall, 190 subjects were enrolled in the study. Procedures were done with the Amulet device (85%) and the Amplatzer Cardiac Plug (15%). Successful implantation was achieved in 99.5% with ≤1 partial recapture in 80% of cases. Single (46.2%) and dual antiplatelet therapy (39.4%) were the most used antithrombotic therapies after LAAO. In-hospital major adverse events rate was 1.5% with no deaths. One patient (0.5%) had cardiac tamponade requiring percutaneous drainage. With a mean follow-up of 19.6 ± 14.8 months, the mortality and stroke rates were 7.7%/year and 2.5%/year, respectively. Follow-up transesophageal echocardiography (TEE) at 2-3 months showed device-related thrombosis in 2.8% and peri-device leak ≥3 mm in 1.2% of patients.
Conclusions
In a large series of patients with chicken wing LAA anatomies undergoing LAAO, the use of the \"sandwich\" technique was feasible and safe. Preprocedural imaging was a key-factor to determine specific measurements.

© 2021 Wiley Periodicals LLC.

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

Valve-in-valve transcatheter aortic valve replacement versus redo surgical valve replacement for degenerated bioprosthetic aortic valve: An updated meta-analysis comparing midterm outcomes.

Thandra A, Abusnina W, Jhand A, Shaikh K, ... Kanmanthareddy A, Alla VM
Background
Redo surgical aortic valve replacement (redo SAVR) and valve-in-valve transcatheter aortic valve replacement (ViV TAVR) are the two treatment strategies available for patients with severe symptomatic bioprosthetic aortic valve dysfunction. Herein, we performed a systematic review and meta-analysis comparing both early and mid-term outcomes of ViV TAVR versus redo SAVR in patients with bioprosthetic aortic valve disease.
Methods
PubMed, Cochrane reviews, and Google scholar electronic databases were searched and studies comparing ViV TAVR versus redo SAVR were included. The primary outcome of interest was mid-term (1-5 years) and 1-year all-cause mortality. Secondary outcomes included were 30-day all-cause mortality, myocardial infarction, pacemaker implantation, stroke, acute kidney injury, major or life-threatening bleeding, and postprocedural aortic valve gradients. Pooled risk ratios (RR) with their corresponding 95% confidence intervals (CIs) were calculated for all outcomes using the DerSimonian-Laird random-effects model.
Results
Nine observational studies with a total of 2,891 individuals and mean follow-up of 26 months met the inclusion criteria. There is no significant difference in mid-term and 1-year mortality between ViV-TAVR and redo SAVR groups with RR of 1.15 (95% CI 0.99-1.32; p = .06) and 1.06 (95% CI 0.69-1.61; p = .8). 30-day mortality rate was significantly lower in ViV-TAVR group with RR of 0.65 (95% CI 0.45-0.93; p = .02). ViV-TAVR group had lower 30-day bleeding, length of stay, and higher postoperative gradients.
Conclusion
Our study demonstrates a lower 30-day mortality and similar 1-year and mid-term mortality for ViV TAVR compared to redo SAVR despite a higher baseline risk. Given these findings and the ongoing advances in the transcatheter therapeutics, VIV TAVR should be preferred over redo SAVR particularly in those at intermediate-high surgical risk.

© 2021 Wiley Periodicals LLC.

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

Safe and rapid radial hemostasis achieved using a novel topical hemostatic patch: Results of a first-in-human pilot study using hydrophobically modified polysaccharide-chitosan.

Anchan R, Venturini J, Larsen P, Lee L, ... Blair J, Nathan S
Background
The transradial approach (TRA) for catheter interventions decreases vascular complications and bleeding versus transfemoral approach. Reducing time to hemostasis and preventing radial artery occlusion (RAO) following TRA are important and incompletely realized aspirations.
Objectives
This first-in-human study sought to evaluate the efficacy of a novel, topically applied compound (hydrophobically modified polysaccharide-chitosan, hm-P) plus minimal required pneumatic compression, to achieve rapid radial arterial hemostasis in post-TRA procedures compared with de facto standards.
Materials and methods
About 50 adult patients undergoing 6 French diagnostic TRA procedures were prospectively enrolled. At procedure completion, a topical hm-P impregnated patch was placed over the dermotomy and TR Band (TRB) compression was applied to the access site. This patch was used as part of a novel rapid deflation protocol with a primary outcome of time to hemostasis. Photographic and vascular ultrasound evaluation of the radial artery was performed to evaluate the procedural site.
Results
Time to hemostasis was 40.5 min (IQR: 38-50 min) with the majority of patients (n = 39, 78%) not requiring reinflation. Patients with bleeding requiring TRB reinflation were more likely to have low body weight and liver dysfunction, with absence of hypertension and LV dysfunction. The rate of RAO was 0% with predischarge radial artery patency documented in all patients using vascular ultrasound. One superficial hematoma was noted. No late bleeding events or cutaneous reactions were reported in the study follow-up.
Conclusions
Topical application of hm-P in conjunction with pneumatic compression was safe and resulted in rapid and predictable hemostasis at the arterial puncture site.

© 2021 Wiley Periodicals LLC.

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

Successful impella-assisted suction thrombectomy of right heart thrombus via the AngioVac device: Advantages, limitations, and alternatives.

Shadman S, Heyliger S, Watts C, Aghili N
An elderly man with cardiogenic shock who was found to have a thrombus burden in the right atrium was described. The thrombus was suctioned via the AngioVac device, with assistance from the Impella CP. This is the first reported case of the use of the AngioVac device in conjunction with left-sided mechanical circulatory devices.

© 2021 Wiley Periodicals LLC.

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

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

Ya\'qoub L, Gad M, Saad AM, Elgendy IY, Mahmoud AN
Background
Randomized trials have confirmed that intravascular ultrasound (IVUS) guidance for percutaneous coronary interventions (PCI) improves long-term clinical outcomes. However, data on real-world utilization of IVUS in ST-elevation myocardial infarction (STEMI) and the impact on short to mid-term outcomes are scarce. We sought to evaluate the utilization and the readmission rates for IVUS-guided PCI in the setting of STEMI.
Methods
Hospitalizations with a primary diagnosis of STEMI undergoing PCI were included from the Nationwide Readmissions Database (NRD) during 2012-2017.
Results
Among 809,601 hospitalizations with STEMI undergoing PCI, 33,644 (4.2%) underwent IVUS-guided PCI. IVUS use increased from 4.2% in 2012 to 5.6% in 2017 (p < .0001). After matching, in-hospital mortality was significantly lower with IVUS use (3.9% vs. 4.6%, p < .0001). The overall readmission rates were similar in both groups. We found that readmission rates due to acute MI at 6 months (5.7% vs. 6%, p = .045) and 11 months (5.1% vs. 6.5%, p = 0.005) as well as the PCI and mortality rates during readmission at 11 months (2.1% vs. 3%, p = .008, and 0.7% vs. 1.4%, p = .002, respectively) were significantly lower in the IVUS group.
Conclusions
The utilization of IVUS in STEMI appears to be slowly increasing. Although overall readmission rates were similar, IVUS was associated with lower in-hospital mortality, lower rates of readmission due to acute MI at 6 and 11 months, as well as lower PCI and mortality at 11 months. Randomized trials evaluating long-term benefits of IVUS in STEMI are needed.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 10 Feb 2021; epub ahead of print

Outcome of left main stem percutaneous coronary intervention in a UK nonsurgical center: A 5-year clinical experience.

Alaour B, Onwordi E, Khan A, Menexi C, ... Hobson A, Dana A
Objectives
To evaluate the outcome of unprotected left main stem (LMS) percutaneous coronary intervention (PCI) in a large UK nonsurgical center.
Background
PCI on unprotected LMS is increasingly regarded as a viable alternative to coronary artery bypass grafting (CABG) with comparable outcome and safety profile in select groups. The safety and efficacy of unprotected LMS PCI without on-site surgical back up has not been reported.
Methods
Data on all unprotected LMS PCI performed between January 2011 and December 2015, was collected from the local PCI database and electronic patient records. In hospital and 1-year major adverse cardiovascular events (MACE) (all-cause mortality, myocardial infarction [MI], stroke, and target vessel revascularization [TVR]) was recorded.
Results
249 patients had unprotected LMS intervention during the study period. 77% of patients (n = 192) were male and mean age was 70 ± 12 years. 31% (n = 78) of cases were elective, 44% (n = 109) NSTEMI, and 25% (n = 62) STEMI. Anatomical distribution: 19% (n = 47) ostial left main, 31% (n = 77) shaft, and 50% (n = 125) bifurcation. The mean SYNTAX score was 24.4 ± 10.6. 22% (n = 55) of patients had severe LV impairment preprocedure and 13% (n = 33) were in cardiogenic shock at presentation. 35% (14%) required IABP support. The vast majority (98.4%) of procedures were successful. No patients required emergency transfer for CABG surgery. There were 25 (10%) in-hospital deaths. 68% of in-hospital deaths occurred in patients undergoing primary PCI for STEMI. 72% of patients who died were in cardiogenic shock at presentation. The 12-month MACE rate was 17.2%. Death occurred in 11.6%, MI in 2.4%, TVR in 2.4%, and stroke in 0.8% of patients.
Conclusion
These results highlight the safety and efficacy of unprotected LMS PCI in a high volume non-surgical center.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 10 Feb 2021; epub ahead of print

Usability of Fantom Encore® scaffold in non-complex bifurcations-Analysis in bench models.

G Toth G, Ono M, Buschmann E, Wu X, ... Serruys PW, Wijns W
Objective
Present bench study aimed to evaluate whether technical characteristics of Fantom Encore® bioresorbable scaffold (BRS) allow to perform proximal optimization/side branch dilation/proximal optimization (POT-SB-POT) technique, as an adequate solution for bifurcation percutaneous coronary intervention.
Methods
Two Fantom Encore® BRS platforms (small with 3.0 mm nominal diameter, n = 7; and large with 3.5 mm nominal diameter, n = 7) were evaluated in bench models, which were designed according to Finet-law and fitted to nominal scaffold diameter in the distal main branch (MB) and fitted to indicated maximal expansion capacity in the proximal main branch (MB). Results were evaluated by (a) fluoroscopy, (b) optical coherence tomography (OCT) and (c) micro-computed tomography (μCT).
Results
All procedures were performed according to the protocol. Careful review of the fluoroscopic loops by an independent operator did not reveal any strut fracture or major deformation. By OCT the overall rate of perfectly apposed struts in the bifurcation area was 15 ± 6% after SB opening, that increased significantly but remained low with 22 ± 9% after final POT (p = .001). Compared to SB ballooning alone, significant benefit of final POT was found in rate of perfect apposition in the proximal MB (15 ± 12% vs. 26 ± 15%, respectively; p = .017) and at the abostial side of polygon of confluence (7 ± 9% vs. 16 ± 13%, respectively; p = .005). μCT analysis revealed a single strut fracture in one case with the small platform, while four cases showed single or multiple strut fractures with the large platform.
Conclusion
The mechanical characteristics of the device are not suitable for use of Conventional techniques for bifurcation PCI such as POT-SB-POT. The use of Fantom Encore® BRS for bifurcation PCI with relevant SB should not be encouraged.

© 2021 Wiley Periodicals LLC.

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

Aortic stenosis in the time of COVID-19: Development and outcomes of a rapid turnaround TAVI service.

Adlam D, Chan N, Baron J, Kovac J
The COVID-19 pandemic has resulted in the cancellation of many elective surgical procedures. This has led to reports of an increase in mortality for patients with non-Covid health conditions due to delayed definitive management. Patients with severe aortic stenosis have a high annual mortality if left untreated. These patients are at risk due to the reduced number of surgical aortic valve replacements and competition for intensive care facilities during the COVID-19 pandemic. This case series suggests that the minimally invasive transcatheter aortic valve implantation is safe to continue during the COVID-19 pandemic with adjustments to the patient pathway to minimize hospital stay and to reduce patient and staff exposure. This helps to reduce the delay of definitive treatment for patients with severe aortic stenosis.

© 2021 Wiley Periodicals LLC.

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

Successful transcatheter treatment for very late migration of a transcatheter aortic valve into the left ventricular outflow tract.

Hale SM, Jessen M, Banerjee S, Kumbhani DJ
Although rare, embolization or migration of transcatheter aortic valves into the left ventricle has been described. We report a case of very late migration of an Edwards Sapien XT (Edwards Lifescience Corporation, Irvine, California) valve that was placed 4 years prior to the development of recurrent severe aortic stenosis with the transcatheter heart valve situated below the native stenotic aortic valve in the left ventricular outflow tract. The management options in this scenario, and outline how they successfully treated this challenging case with transfemoral TAV-in-TAV have also been discussed.

© 2021 Wiley Periodicals LLC.

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

Effect of institutional transcatheter aortic valve replacement volume on mortality: A systematic review and meta-analysis.

Kir D, Shapero K, Chatterjee S, Grimshaw A, ... Goldsweig AM, Desai NR
Objective
We sought to conduct a systematic review and network meta-analysis to examine the association between institutional transcatheter aortic valve replacement (TAVR) volume and all-cause mortality.
Background
Since inception in 2011, there has been an exponential increase in the number of TAVR centers across the world. Multiple studies have questioned if a relationship exists between institutional TAVR volume and patient outcomes.
Methods
We performed a systematic literature search for relevant articles using a combination of free text terms in the title/abstract related to volume, TAVR, and patient outcomes. Two reviewers independently screened all titles/abstracts for eligibility based on pre-specified criteria. All-cause mortality data was pooled from eligible studies and centers were categorized as low-(30-50 cases), intermediate-, or high-volume (75-130 cases) based on their annual TAVR volumes.
Results
Our search yielded an initial list of 11,153 citations, 120 full text studies were reviewed and 7 studies met all inclusion and exclusion criteria, yielding a total of 1,93,498 TAVRs. Categorized according to center\'s annual volume; 25,062 TAVRs were performed in low-, 77,093 in intermediate- and 91,343 in high-volume centers. Network meta-analysis showed a relative reduction in mortality rates of 37%, 23% and 19%, for high volume versus low volume centers, high volume versus intermediate volume centers and intermediate versus low volume centers, respectively.
Conclusions
Existing research clearly shows an inverse relationship between annual TAVR procedural volume and all-cause mortality. We need to focus on development of strong referral networks and consolidation rather than expansion of existing TAVR centers to improve patient outcomes, while ensuring adequate access-to-care.

© 2021 Wiley Periodicals LLC.

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

Learning and innovation among interventional cardiologists: Insights from an international survey.

Vemmou E, Nikolakopoulos I, Xenogiannis I, Karacsonyi J, ... Bergmark BA, Brilakis ES
Background
The willingness of interventional cardiologists to adopt innovation and implement changes in day-to-day practice has received limited study.
Methods
Online-based survey on learning and innovation: 38 questions were distributed via email list to interventional cardiologists.
Results
The survey was distributed to 8,110 e-mails and completed by 621 (7.7%, 91.8% men, 60% in the 35 to 54-year-old age group). Of the respondents who perform coronary interventions, 45% perform >100 cases of noncomplex percutaneous coronary interventions per year and of the respondents who perform structural interventions, 15% perform more than >100 transcatheter aortic valve replacements per year. Most respondents (86.7%) rate themselves as highly likely/likely to introduce recently approved equipment in everyday practice and 47.5% have tried a new coronary guidewire in the past 6 months. The most common reasons for reluctance to use new equipment were high cost (64%) and uncertainty about whether it provides additional benefits compared with existing equipment (48.5%). Radial access in STEMI cases is always used by 43.6% of the respondents and 55% always use radial access for coronary angiography. Of those who use femoral access, 32% always use ultrasound guidance and 91% have used a closure device in the last 6 months. Most respondents (80%) read journals to keep up with current practice and believe that the most effective way to learn is through attendance of workshops/short courses (77.5%). Most respondents (69%) are involved in research.
Conclusion
Interventional cardiologists who participated in the survey are highly likely to adopt innovation in daily clinical practice.

© 2021 Wiley Periodicals LLC.

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

Tricuspid valve vegetation debulking using the AngioVac system.

Bangalore S, Alviar CL, Vlahakis S, Keller N
Tricuspid valve endocarditis with recurrent septic pulmonary emboli is an indication for surgery. We present the case of a 36-year old man with tricuspid valve endocarditis and septic pulmonary emboli with percutaneous extraction of the vegetation. We discuss the nuances of such an approach and the need for more evidence in the management of these complex patients.

© 2021 Wiley Periodicals LLC.

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

Balloon versus self-expandable transcatheter aortic valve implantation for bicuspid aortic valve stenosis: A meta-analysis of observational studies.

Sá MPBO, Simonato M, Van den Eynde J, Cavalcanti LRP, ... Kaneko T, H L Tang G
Background
There is a rising trend for transcatheter aortic valve implantation (TAVI) in bicuspid aortic stenosis patients. Data on the use of self-expandable (SEV) vs. balloon-expandable (BEV) valves in these patients are scarce. Therefore, we systematically compared clinical outcomes in bicuspid aortic stenosis patients treated with SEV and BEV.
Methods
Data were extracted from PubMed/MEDLINE, EMBASE, CENTRAL/CCTR, ClinicalTrials.gov, SciELO, LILACS, Google Scholar and reference lists of relevant articles. Eight studies published from 2013 to 2020 including a total of 1,080 patients (BEV: n = 620; SEV: n = 460) were selected. Primary endpoints were procedural, 30-day and 1-year mortality. Secondary endpoints were new pacemaker implantation, annular rupture, coronary obstruction, moderate-to-severe paravalvular leak, need of second valve, stroke and acute kidney injury.
Results
We found no statistically significant difference in mortality between patients treated with BEV vs. SEV during index procedure, at 30 days and at 1 year. BEVs showed a statistically significant higher risk of annulus rupture (2.5%) in comparison with SEV (0%) (OR 5.81 [95% CI, 3.78-8.92], p < .001). New generation BEVs were also associated with significantly less paravalvular leak when compared to new generation SEVs (OR 0.08 [95% CI, 0.02-0.35], p = .001).
Conclusions
This meta-analysis of observational studies of TAVI for bicuspid valves, showed no difference in short- and mid-term TAVI mortality with BEVs and SEVs. BEVs presented a higher risk of annular rupture in comparison with SEV.

© 2021 Wiley Periodicals LLC.

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

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

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

© 2021 Wiley Periodicals LLC.

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

Transcatheter pulmonary denervation in patients with left heart failure with reduced ejection fraction and combined precapillary and postcapillary pulmonary hypertension: A prospective single center experience.

Witkowski A, Szumowski Ł, Urbanek P, Jastrzębski J, ... Parulski A, Zieliński T
Objectives
The present study was a prospective, single-center, single-arm study to investigate the efficacy of transcatheter pulmonary artery denervation (TPADN) in patients with combined postcapillary and precapillary PH (Cpc-PH) associated with left heart failure with reduced ejection fraction (HF-rEF).
Background
Pulmonary hypertension (PH) in patients with left ventricular systolic dysfunction has a negative impact on outcome.
Methods
The combination of pulmonary artery systolic pressure (PAPs) ≥60 mmHg, transpulmonary pressure gradient (TPG) ≥12 mmHg, nonreversible mean PAP, and pulmonary vascular resistance (PVR) ≥3.5 Wood Units was considered as too high risk for heart transplantation (HTx). The clinical efficacy endpoint was an improvement in 6-min walking test and the hemodynamic endpoints were changes in PAPs, PVR, and TPG between baseline and 6 months. Circumferential radiofrequency applications were delivered around distal main, left and right pulmonary arteries. At each ablation point temperature was 45°C and energy 10 W.
Results
TPADN was performed in 10 patients. At 6-month in 5 patients we observed reduction in PAP, PVR, TPG, and DPG and then 1 had successful HTx, 2 are on HTx waiting list, 2 received LVADs, 2 patients did not improve, and 3 patients died.
Conclusions
TPADN may be beneficial in selected patients with HF-rEF and Cpc-PH.

© 2021 Wiley Periodicals LLC.

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

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

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

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

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

An ultra-low-profile 0.85 mm Nano Hydro balloon to treat wire-crossable balloon-uncrossable lesions: A useful tool in CTO armamentarium.

Adusumalli S, Dautov R
Balloon uncrossable lesions are commonly encountered during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). A sequential strategy and planning are required to tackle such lesions. We present a case series of severely calcified, device uncrossable lesions where the traditional strategies failed and an ultra-low-profile (0.85 mm) balloon was crucial to successful PCI. To our best knowledge, this is the first case series describing the use of this balloon in real world.

© 2021 Wiley Periodicals LLC.

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

Sex difference in long-term clinical outcomes after percutaneous coronary intervention: A propensity-matched analysis of National Health Insurance data in Republic of Korea.

Lee SH, Choi J, Chang YJ, Shin ES, ... Lee SH, Choi JH
Objective
We investigated the gender difference in the 5-year outcome after percutaneous coronary intervention (PCI) using an unselected population data.
Background
Sex-specific outcome after percutaneous coronary intervention (PCI) is not consistent among studies.
Methods
A total of 48,783 patients were enrolled from a Korean nationwide cohort of PCI in year 2011. Outcomes adjusted with age and propensity for clinical characteristics were compared. Primary outcome was 5-year cumulative incidence of all-cause death. Nonfatal major adverse clinical event (MACE) consisting of revascularization, shock, or stroke was also assessed.
Results
In unadjusted analysis, women were older and had higher frequency of comorbidities including hypertension, hyperlipidemia, and diabetes compared to men (p < .001, all). Women had higher 5-year death risk than men (21.8 vs. 17.3%; hazard ratio [HR] 1.29, 95% confidential interval [CI] 1.23-1.34). In propensity score-matched analysis (N = 28,924), women had lower 5-year death risk (20.2 vs. 26.1%, HR 0.75, 95% CI 0.71-0.78). This lower death risk in women was consistent in subgroup analyses of age, risk factors, and clinical diagnosis including angina or acute myocardial infarction (p < .05, all).
Conclusions
Older age and more common comorbidities in women contributed to the apparent worse outcome after PCI in women. After adjusting these disadvantages, women had better outcome after PCI than men.

© 2021 Wiley Periodicals LLC.

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

Plaster pipes and crystalized graphite: Open transventricular transcatheter aortic valve replacement for failed mechanical aortic valve prostheses in the porcelain aorta.

Yong MS, Camuglia AC, Cox SV, Cole CM
Patients with a true porcelain aorta and a failed mechanical aortic valve prosthesis have limited treatment options. Using a hybrid of an open trans-ventricular approach with peripheral cardiopulmonary bypass and integration of transcatheter techniques this challenge can be overcome. Trans-ventricular mechanical valve extraction (with transcatheter endovascular occlusion and cardioplegia) followed by direct ante-grade transcatheter heart valve implantation offers a potential solution to this conundrum. The procedure described is a novel technique that allows for the effective treatment of patients with failed mechanical surgical aortic valve prostheses in the setting of an inoperable porcelain aorta. In addition, a collaborative integrated multi-disciplinary heart team environment is required for the management of these complex patients.

© 2021 Wiley Periodicals LLC.

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

Real-world experience of suture-based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience.

Case BC, Kumar S, Yerasi C, Forrestal BJ, ... Rogers T, Waksman R
Objectives
We analyzed post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for suture-based vascular closure devices (VCDs) - Perclose ProGlide (Abbott, Chicago, Illinois) and Prostar XL (Abbott).
Background
Suture-based VCDs are mostly used for large-bore femoral arterial access-site closure. Real-world, contemporary experience on the most commonly reported complications and modes of failure associated with these devices is limited.
Methods
Post-marketing surveillance data from the FDA MAUDE database, for the ProGlide system and for the Prostar XL system, were analyzed, yielding 827 Perclose ProGlide reports and 175 Prostar XL reports.
Results
Of the 827 reports of major complications involving the Perclose ProGlide devices, 404 reports involved injury, and one involved death related to the device. In the Prostar XL analysis, 94 reports involved injury, and one involved death. Bleeding from vessel injury was the most common adverse outcome described with both devices, followed by hematoma and thrombus. Surgical repair was the most commonly used treatment strategy. In terms of device malfunction, suture-related malfunction (212 reports) was most commonly seen in the Perclose ProGlide group, while failed deployment was most commonly seen in the Prostar XL group.
Conclusions
Our analysis of the MAUDE database demonstrates that in real-world practice, suture-based VCDs were found to be associated with complications, including vascular injury, difficulties with the device itself, and even death. Ongoing user education and pre-procedural patient selection are important to minimize risks associated with suture-based vascular closure devices.

© 2021 Wiley Periodicals LLC.

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

Predicting 2-year all-cause mortality after contemporary PCI: Updating the logistic clinical SYNTAX score.

Chichareon P, van Klaveren D, Modolo R, Kogame N, ... Xu B, Serruys PW
Aims
We aimed to update the logistic clinical SYNTAX score to predict 2 year all-cause mortality after contemporary percutaneous coronary intervention (PCI).
Methods and results
We analyzed 15,883 patients in the GLOBAL LEADERS study who underwent PCI. The logistic clinical SYNTAX model was updated after imputing missing values by refitting the original model (refitted original model) and fitting an extended new model (new model, with, selection based on the Akaike Information Criterion). External validation was performed in 10,100 patients having PCI at Fu Wai hospital. Chronic obstructive pulmonary disease, prior stroke, current smoker, hemoglobin level, and white blood cell count were identified as additional independent predictors of 2 year all-cause mortality and included into the new model. The c-indexes of the original, refitted original and the new model in the derivation cohort were 0.74 (95% CI 0.72-0.76), 0.75 (95% CI 0.73-0.77), and 0.78 (95% CI 0.76-0.80), respectively. The c-index of the new model was lower in the validation cohort than in the derivation cohort, but still showed improved discriminative ability of the newly developed model (0.72; 95% CI 0.67-0.77) compared to the refitted original model (0.69; 95% CI 0.64-0.74). The models overestimated the observed 2 year all-cause mortality of 1.11% in the Chinese external validation cohort by 0.54 percentage points, indicating the need for calibration of the model to the Chinese patient population.
Conclusions
The new model of the logistic clinical SYNTAX score better predicts 2 year all-cause mortality after PCI than the original model. The new model could guide clinical decision making by risk stratifying patients undergoing PCI.

© 2021 Wiley Periodicals LLC.

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

Temporal outcomes of transcatheter mitral valve replacement in native mitral valve disease with annular calcification.

Al-Hijji MA, ElHajj S, El Sabbagh A, Alkhouli MA, ... Rihal C, Guerrero M
Background
Surgical intervention in patients with native mitral disease due to severe mitral annular calcification (MAC) carries significant risk. Transcatheter mitral valve replacement (TMVR) using balloon-expandable aortic transcatheter heart valve (THV) in MAC had emerged as alternative treatment.
Objectives
We aim to study the temporal change in clinical outcomes of the procedure at a single center.
Methods
We retrospectively studied 23 patients who underwent TMVR in MAC at Mayo Clinic from January, 14, 2014 to March, 15, 2019. Cases were divided into early (n = 11) and late (n = 12) experience. The primary end point was 30-day all-cause mortality. The secondary end points were immediate technical success, 30-day procedural success, and 1-year all-cause mortality.
Results
Mean age of patients was 75.2 ± 8.9 years and 17 (74.0%) were female. Median STS score for 30-day mortality was 8 (Interquartile range 4.3-13.4) for the entire population. Immediate technical success was achieved in 21 out of 23 patients (two failures in the early experience were related to tamponade and procedural death). Thirty-day procedural success was higher in the late experience (10 out of 12 patients) compared to early experience (5 out of 11 patients, p = .06). Four deaths in the first 30-days were observed in the early experience while all patients survived to hospital discharge in the late experience (p = .01).
Conclusions
Procedural success and 30-day survival of transcatheter mitral valve replacement in severe mitral annular calcification procedure using balloon-expandable aortic prosthesis had improved over the years. This is likely attributed to significant advancement in procedural planning, valve design, and techniques.

© 2021 Wiley Periodicals LLC.

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

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

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

© 2021 Wiley Periodicals LLC.

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

Outcomes of in-hospital cardiac arrest in COVID-19 patients: A proportional prevalence meta-analysis.

Mir T, Sattar Y, Ahmad J, Ullah W, ... Alraies MC, Qureshi WT
Background
Limited epidemiological data are available on the outcomes of in-hospital cardiac arrest (CA) in COVID-19 patients.
Methods
We performed literature search of PubMed, EMBASE, Cochrane, and Ovid to identify research articles that studied outcomes of in-hospital cardiac arrest in COVID-19 patients. The primary outcome was survival at discharge. Secondary outcomes included return of spontaneous circulation (ROSC) and types of cardiac arrest. Pooled percentages with a 95% confidence interval (CI) were calculated for the prevalence of outcomes.
Results
A total of 7,891 COVID patients were included in the study. There were 621 (pooled prevalence 8%, 95% CI 4-13%) cardiac arrest patients. There were 52 (pooled prevalence 3.0%; 95% CI 0.0-10.0%) patients that survived at the time of discharge. ROSC was achieved in 202 (pooled prevalence 39%;95% CI 21.0-59.0%) patients. Mean time to ROSC was 7.74 (95% CI 7.51-7.98) min. The commonest rhythm at the time of cardiac arrest was pulseless electrical activity (pooled prevalence 46%; 95% 13-80%), followed by asystole (pooled prevalence 40%; 95% CI 6-80%). Unstable ventricular arrhythmia occurred in a minority of patients (pooled prevalence 8%; 95% CI 4-13%).
Conclusion
This pooled analysis of studies showed that the survival post in-hospital cardiac arrest in COVID patients is dismal despite adequate ROSC obtained at the time of resuscitation. Nonshockable rhythm cardiac arrest is commoner suggesting a non-cardiac cause while cardiac related etiology is uncommon. Future studies are needed to improve the survival in these patients.

© 2021 Wiley Periodicals LLC.

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

Optimizing mechanical circulatory support hemodynamics using coronary sinus pacing.

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

© 2021 Wiley Periodicals LLC.

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

Characteristics and outcomes of surgically ineligible patients with multivessel disease treated with percutaneous coronary intervention.

Shields MC, Ouellette M, Kiefer N, Kohan L, ... Ailawadi G, Ragosta M
Objectives
In this study we evaluated the clinical characteristics and outcomes of surgically ineligible patients with coronary artery disease (CAD) who underwent multivessel percutaneous coronary intervention (PCI).
Background
Patients with multivessel CAD who are surgically ineligible and undergo PCI are not well represented in large trials.
Methods
Out of 1,061 consecutive patients who underwent a non-emergent PCI for unprotected left main or multivessel CAD at the University of Virginia Medical Center, 137 patients were determined to be surgically ineligible for coronary artery bypass graft (CABG) surgery by a heart team. The clinical characteristics and reasons for surgical ineligibility were collected. The coronary angiograms were reviewed and the SYNTAX score calculated. The Society of Thoracic Surgeons (STS) score was calculated. Outcomes were determined at 30 days and 1-year.
Results
The mean age of the cohort was 71 and 59% were women. Hypertension, hyperlipidemia, tobacco abuse, and diabetes were common comorbidities. The average SYNTAX score was 22. The most commonly cited reasons for surgical ineligibility were advanced age, frailty, severe lung disease, ejection fraction ≤ 30% and STS score ≥ 8%. Outcomes at 30 days were excellent and better than those predicted by STS for surgery. Frailty and STS score predicted one-year outcomes.
Conclusions
Patients undergoing PCI for multivessel disease who are surgically ineligible have multiple risk factors and comorbidities. Frailty, lung disease, poor left ventricular function, and high STS score represent common reasons for surgical ineligibility. Frailty and the STS score better predict one-year outcomes after PCI compared to the SYNTAX score.

© 2021 Wiley Periodicals LLC.

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

Vascular complications with a plug-based vascular closure device after transcatheter aortic valve replacement: Predictors and bail-outs.

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

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

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

Performance of quantitative flow ratio in patients with aortic stenosis undergoing transcatheter aortic valve implantation.

Sejr-Hansen M, Christiansen EH, Ahmad Y, Vendrik J, ... Terkelsen CJ, Eftekhari A
Objectives
This study aims to evaluate the diagnostic performance of quantitative flow ratio (QFR) pre transcatheter aortic valve implantation (TAVI) in patients with aortic valve stenosis (AS) and coronary artery disease (CAD). Post-TAVI fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) was used as reference.
Background
CAD is prevalent in patients with AS, but the hemodynamics of AS confounds evaluation using pressure wire-based assessments. QFR might be less sensitive to the presence of AS thereby allowing for CAD evaluation before aortic valve replacement. Further, QFR does not require the use of pressure wire and therefore has the potential for reducing costs and complications related to insertion of a coronary pressure wire.
Methods
The diagnostic performance of QFR in coronary angiograms from 28 patients undergoing TAVI was evaluated. In all patients, both FFR and iFR were measured pre- and immediately post-TAVI while QFR was measured pre-TAVI.
Results
Using post-TAVI FFR and iFR as reference the diagnostic accuracy of pre-TAVI QFR were 83% (95%CI; 68-97) and 52% (95%CI; 30-74) p = .008, respectively.
Conclusions
Pre-TAVI QFR showed a good diagnostic performance using post-TAVI FFR as reference. QFR could become a wire-free, safe, and quick way of evaluating CAD in patients with severe AS undergoing TAVI.

© 2021 Wiley Periodicals LLC.

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

Predictors of reduced cardiac index in patients with acute submassive pulmonary embolism.

Ammari Z, Al-Sarie M, Ea A, Sangera R, ... Sun Z, Gupta R
Objectives
Determine the baseline clinical, laboratory, and echocardiographic values that predict reduced cardiac index (CI) among subjects with acute submassive pulmonary embolism (PE).
Background
Submassive PE represents a large portion of acute PE population and there is controversy regarding optimal treatment strategies for these patients. There is significant heterogeneity within the submassive PE population and further refinement of risk stratification may aid clinical decision-making.
Methods
We identified subjects with normotensive acute PE who underwent echocardiogram and right heart catheterization (RHC) prior to catheter-directed thrombolysis (CDT). We sought to determine the predictors of reduced CI, defined as CI < 2.2 L min^-1 m^-2 .
Results
Thirty-two subjects met the inclusion criteria and 41% had reduced CI. Baseline variables did not distinguish subjects with reduced versus normal CI. Brain natriuretic peptide (BNP) was significantly different between the reduced versus normal CI groups (BNP 440 vs. 160 pg/ml, p = .004, respectively). Univariate logistic regression identified BNP, right ventricular (RV):left ventricular (LV) diameter ratio, tricuspid annular plane systolic excursion (TAPSE), and right ventricular systolic pressure as predictors of reduced CI. In a multivariate logistic regression model, only TAPSE was an independent predictor of reduced CI. ROC curve analysis identified the following optimal cut points for prediction of reduced CI: BNP > 216 pg/ml, RV:LV ratio > 1.41, or TAPSE <1.6 cm.
Conclusions
Almost half of subjects with acute submassive PE have reduced CI, despite normal systemic blood pressure. Optimal cut points for BNP, RV:LV ratio, and TAPSE were identified to predict reduced CI among patients with acute PE. These findings may aid in clinical decision-making and risk stratification of patients with acute submassive PE.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Jan 2021; 97:292-298

Transcatheter mitral valve repair in patients with chronic liver disease: Insights from the national inpatient sample.

Khan MU, Khan MZ, Khan SU, Kaluski E
Objective
To evaluate contemporary national trends of morbidity, mortality, and healthcare utilization in patients with mitral regurgitation (MR) and co-existing chronic liver disease (CLD) undergoing transcatheter mitral valve repair (TMVR).
Methods
The National Inpatient Sample (NIS) was used to assess trends in patients undergoing TMVR between January 2012 and December 2017. Propensity match analysis was done to compare it to subjects without underlying CLD. Logistic regression analysis was used to identify predictors of in-hospital mortality.
Results
Of 15,270 patients undergoing TMVR, 569 (3.7%) had coexisting CLD. Patients with CLD had a higher proportion of males (61.3 vs 52.6%; p < .01), congestive heart failure (6.9 vs 1.0%; p < .01), renal failure (42.2 vs 36.7%; p < .01), and peripheral vascular disease (19.3 vs 12.5%; p < .01). After propensity matching subjects with CLD had significantly higher hospital mortality (19.8 vs 4.6%; p < .01), acute kidney injury (46.1 vs 37.8%; p < .01), cardiogenic shock (25.4 vs 12.1%; p < .01), mechanical ventilation (26.3 vs 14.0; p < .01), pneumothorax (6.6 vs <2%.; p < .01), length of stay (5 vs 9 days), and average cost of hospitalization (209,573 vs 250,587 $; p < .01). Over the years, in-hospital mortality in patients receiving TMVR has improved in both patients with (from 33.3 in 2013 to 22.2% in 2017) and without CLD (from 2.7 in 2011 to 1.6% in 2017).
Conclusion
Patients with MR undergoing TMVR, with coexisting CLD bear substantially higher comorbidities, complication rates, and inpatient mortality compared with those without CLD. A favorable temporal trend of in-hospital mortality among these subjects is noteworthy.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Jan 2021; 97:344-352

Coronary artery dissection following radiofrequency ablation for atrial fibrillation: Case report and review of the literature.

Reddy SA, V Khialani B, Kyranis S, P Hoole S
Coronary artery injury following catheter ablation for cardiac arrhythmias is very rare. We present a case of left circumflex (LCx) coronary artery dissection causing inferoposterior ST-elevation myocardial infarction following radiofrequency (RF) ablation for atrial fibrillation (AF) in a 39-year-old male with no cardiovascular risk factors. This was confirmed on coronary angiography and intracoronary vascular ultrasound (IVUS). The likely etiology is thermal injury during RF ablation for AF, due to the close proximity of the left atrial appendage and left pulmonary veins to the LCx. He was successfully treated with primary percutaneous coronary intervention with good outcome. This is, to our knowledge, the first reported case of proven acute coronary dissection secondary to RF ablation for AF reported in the literature, and highlights the importance of considering this as a mechanism for coronary occlusion in these patients.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Jan 2021; 97:287-291

Acute myocardial infarction and large coronary thrombosis in a patient with COVID-19.

Tedeschi D, Rizzi A, Biscaglia S, Tumscitz C
This is a case report of a 60-year-old male, without any cardiovascular risk factor and no cardiac history admitted to hospital with a diagnosis of interstitial pneumonia caused by coronavirus disease 2019 (COVID-19). After 7 days, the blood tests showed a significant rise of inflammatory and procoagulant markers, along with a relevant elevation of high-sensitivity Troponin I. Electrocardiogram and transthoracic echocardiogram (TTE) were consistent with a diagnosis of infero-posterolateral acute myocardial infarction and the patient was transferred to the isolated Cath Lab for primary percutaneous coronary intervention (PCI). The angiography showed an acute massive thrombosis of a dominant right coronary artery without clear evidence of atherosclerosis. Despite the optimal pharmacological therapies and different PCI techniques, the final TIMI flow was 0/1 and after 3 hr the clinical condition evolved in cardiac arrest for pulseless electric activity. Acute coronary syndrome-ST-elevation myocardial infarction is a relevant complication of COVID-19. Due to high levels of proinflammatory mediators, diffuse coronary thrombosis could occur even in patients without cardiac history or comorbidities. This clinical case suggests that coronary thrombosis in COVID-19 patients may be unresponsive to optimal pharmacological (GP IIb-IIIa infusion) and mechanical treatment (PCI).

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Jan 2021; 97:272-277

Incidence and short-term outcomes of surgical bailout after transcatheter mitral valve repair with the MitraClip system.

Isogai T, Saad AM, Shekhar S, Ahuja KR, ... Krishnaswamy A, Kapadia SR
Objectives
This study sought to investigate the incidence and outcomes of surgical bailout (SB) after transcatheter mitral valve repair (TMVr) with MitraClip.
Background
TMVr poses a risk of serious procedural complications, possibly requiring urgent open surgery for SB. However, little is known about the risk of SB cases after TMVr.
Methods
We retrospectively identified patients who underwent TMVr using the Nationwide Readmissions Database 2014-2017. SB was defined as open thoracotomy for heart and aorta during the same hospitalization. Annual hospital volume was defined as the annual number of TMVr cases in each hospital in each year.
Results
Among 15,032 eligible patients, SB was required in 214 (1.42%), of whom 134 (62.6%) underwent mitral valve surgery (113 replacements; 21 repairs). The incidence of SB was decreasing significantly over the 4 years (5.26% in 2014; 0.43% in 2017; p_trend  < .001). There was a significant nonlinear, inverse association of annual hospital volume with the incidence of SB. In-hospital death (15.0 vs. 2.1%; p < .001) and other in-hospital adverse events were significantly more frequent in patients with than without SB, whereas the 30-day readmission rate was similar (13.2 vs. 15.1%; p = .572). After adjustment for patient and hospital characteristics, SB was significantly associated with higher in-hospital mortality (odds ratio = 6.67, 95% confidence interval = 4.35, 10.23, p < .001).
Conclusions
This study suggests that although the incidence of SB after TMVr is decreasing, SB is required more frequently in lower-volume hospitals and carries high in-hospital mortality. Further efforts are needed to understand the reasons for SB and improve outcomes in patients needing SB.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Jan 2021; 97:335-341

Transcatheter mitral valve in ring, hazards of long anterior mitral leaflet and 3-dimensional rings.

Sekaran N, Horne BD, Doty JR, Reid BB, ... Clayson SE, Whisenant BK
Objectives
The purpose of this study was to define anterior mitral leaflet (AML) length and mitral ring characteristics associated with LVOT obstruction and PVL following MViR.
Background
Transcatheter Mitral Valve in Ring (MViR) procedural complications including parvalvular leak (PVL) and left ventricular outflow tract (LVOT) obstruction are frequent.
Methods
Clinical records, computer tomographic scans (CTs) and echocardiograms of consecutive MViR patients were retrospectively reviewed for anterior mitral leaflet length, CT-simulated neoLVOT, and aortomitral angle among patients with and without MViR-induced LVOT obstruction. Acute and 1-year outcomes are described.
Results
Twenty-two patients underwent MViR. Technical success was achieved in 13/22 (57.1%) patients, limited by paravalvular regurgitation requiring second transcatheter heart valves (THVs) in seven patients. Second valves were needed in 6/11 (54.5%) patients with 3-dimensional rings but 1/11 (9.1%, p = .06) of patients with planar rings. Procedure success at 30 days was achieved in 20/22 (90.9%) patients. There were no procedural, in-hospital, or 30-day deaths. Two patients developed significant LVOT obstruction, one managed with urgent surgery and one with elective alcohol septal ablation. Anterior mitral leaflets were longer among the two patients with LVOT obstruction than the 20 patients who did not develop LVOT obstruction when measured by TEE (30 mm vs. 21 mm, p = .009) or by CT (29 mm vs. 22 mm, p = .026).
Conclusions
AML >25 mm increases the risk of MViR induced LVOT obstruction. PVL is common, particularly in 3-dimensional rings which can be managed with a second THV.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Jan 2021; 97:353-358

The predictive value of CHADS2 score for subclinical cerebral ischemia after carotid artery stenting (from the PREVENT-CAS trial).

Çelik Ö, Güner A, Kalçık M, Güler A, ... Topel Ç, Ertürk M
Background
Carotid artery stenting (CAS) is being increasingly used as an alternative revascularization procedure to carotid endarterectomy; however, subclinical ischemic cerebral lesions after CAS remain as a matter of concern. Hence, we aimed to assess the clinical utility of the CHADS₂ score in predicting subclinical ischemic events after CAS.
Methods
We prospectively evaluated 107 patients (mean age: 70.4 ± 6.6 years, male:77) who underwent CAS for carotid artery revascularization. The patients having symptomatic transient ischemic attack or stroke after CAS were excluded. The presence of new hyperintense lesion on diffusion-weighted imaging (DWI) without any neurological findings was considered as silent ischemia. Patients were classified into two groups as DWI-positive and DWI-negative patients.
Results
Among study population, 28 patients (26.2%) had subclinical embolism. The DWI-positive group had a significantly higher CHADS2 scores, older age, more frequent history of stroke, higher proportion of type III aortic arch, and longer fluoroscopy time than the DWI-negative group. Increased CHADS₂ score was identified as one of the independent predictors of silent embolism (OR = 5.584; 95%CI: 1.516-20.566; p = .010), and CHADS₂ score higher than 2.5 predicted subclinical cerebral ischemia with a sensitivity of 72% and a specificity of 71% (AUC: 0.793; 95% CI: 0.696 - 0.890; p < .001).
Conclusions
CHADS₂ score was able to predict the risk of periprocedural subclinical ischemic events in CAS and might be of clinical value in the management of patients with carotid artery stenosis.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Jan 2021; 97:301-309

Long-term clinical outcomes after self-expandable bare nitinol stent implantation for femoropopliteal occlusive disease in hemodialysis patients.

Ito R, Ishii H, Oshima S, Nakayama T, ... Kakuno M, Murohara T
Objectives
To compare the long-term clinical outcomes after self-expandable bare nitinol stent (BNS) implantation between hemodialysis (HD) and non-HD patients with femoropopliteal (FP) disease.
Background
Although a BNS has been commonly used in patients with FP disease, the long-term efficacy of BNSs in HD patients remains unknown.
Methods
In total, 427 HD patients treated with a BNS for FP disease were enrolled, along with 157 non-HD patients as a control group. Over the following 5 years, the incidence of target lesion revascularization (TLR), major amputation and mortality was investigated. We also performed propensity-score matching analysis.
Results
The 5-year TLR rate (45.2 vs. 32.5%, p = .013) and mortality rate (39.3 vs. 14.0%, p = .0002) were significantly higher in the HD group than in the non-HD group. The major amputation rate was comparable between the groups (7.2% in the HD group vs. 2.8% in the non-HD group, p = .16). In the propensity-score-matched cohort, the TLR rate, and mortality rate were remained higher in the HD group than in the non-HD group (48.9 vs. 34.1%, hazard ratio [HR] 2.11, 95% confidence interval [CI] 1.30-3.49, p = .0024, and 47.9 vs. 12.0%, HR 3.38, 95% CI 1.86-6.56, p < .0001, respectively). The adjusted amputation rate was consistently similar between the groups (1.7% in the HD group vs. 2.7% in the non-HD group, HR 0.90, 95% CI 0.26-2.99, p = .86).
Conclusions
The TLR rate and mortality at 5 years post BNS implantation for FP disease were significantly higher in HD patients than in non-HD patients, though the limb salvage rate was similar.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Jan 2021; 97:318-324

Performance of the Wingman catheter in peripheral artery chronic total occlusions: Short-term results from the international Wing-It trial.

Laird JR, Mathews SJ, Brodmann M, Soukas PA, Schmidt A, Wing-It Trial Investigators
Objectives
To determine the safety and effectiveness of a peripheral artery chronic total occlusion (CTO) crossing catheter following failed crossing attempts with standard guidewires.
Background
CTO crossing remains a challenge during peripheral artery interventions.
Methods
In this prospective, international, single-arm study, patients with a peripheral artery CTO that was uncrossable with standard guidewires were treated with a crossing catheter (Wingman, Reflow Medical). The primary efficacy endpoint of CTO crossing success was compared to a performance goal of 70.7%. The primary composite safety endpoint (major adverse event [MAE], clinically significant perforation or embolization, or grade C or greater dissection) was assessed over a 30-day follow-up period and compared to a performance goal of 13.0%.
Results
A total of 85 patients were treated using the Wingman catheter for peripheral artery CTO crossing. Key patient characteristics were mean age of 71±9 years, 66% male, and mean lesion length of 188±94 mm in the superficial femoral artery (71%), popliteal artery (15%), or infrapopliteal arteries (14%). Both primary endpoints of the trial were met¾CTO crossing success was 90% (lower confidence limit=82.5%) and 5 primary safety events occurred in 4 (4.8%) patients (upper confidence limit=10.7%). Over 30 days of follow-up, Rutherford score decreased by at least 2 categories in 74% patients; the percentage of patients with normal hemodynamics assessed with the ankle-brachial index increased from 1% to 51%.
Conclusions
Among patients with a CTO that was unable to be crossed with a standard guidewire, the Wingman catheter was able to cross 90% of occlusions with a favorable safety profile.

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

Catheter Cardiovasc Interv: 31 Jan 2021; 97:310-316

Management of peri-device leak following left atrial appendage closure: A systematic review.

Sleiman JR, Lewis AJ, Perez EJ, Sanchez AM, ... Asher CR, Cubeddu RJ
Objective
This study aimed to examine the cumulative experience of peri-device leak (PDL) closure following left atrial appendage (LAA) closure.
Background
The management of PDL following LAA closure remains controversial. While PDL closure has been proposed, procedural features and clinical outcomes have not been well established.
Methods
A systematic review of all published cases of PDL closure with available anatomical, procedural, and clinical outcomes was performed.
Results
We identified 18 indexed publications and 110 cases between April 2013 and March 2020. 71 patients (mean age 72 ± 8 yrs), met study criteria and were included. PDL closure was most common in males, bilobar LAA morphology, and after Watchman procedures. The mean PDL size was 7.6 ± 5.8 mm (range 2-26 mm). Leaks were classified according to size: small (<5 mm; 45%), moderate (≥5-9 mm; 25%), and large (≥10 mm; 30%). Endovascular coils and endovascular plugs were used to close both small and moderate sized leaks, and second LAA closure devices were exclusively used for large PDLs. Successful PDL closure occurred in 90%, and was similar between PDL sizes and types of occluder used. Procedural complication rates were uncommon (2.8%). No strokes were reported following PDL closure at 6 months.
Conclusions
In patients with PDL for whom discontinuation of OAC may be considered unsafe, percutaneous closure using a tailored approach with either endovascular coils, plugs, or second occluder represents a safe, and feasible alternative associated with favorable clinical outcomes.

© 2021 Wiley Periodicals LLC.

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

Transcatheter valve-in-valve implantation versus surgical redo aortic root replacement in patients with degenerated freestyle aortic bioprosthesis.

Vukadinovikj A, Baumgártner E, Bohmann K, Härter D, Wimmer-Greinecker G, Burgdorf C
Background
Transcatheter aortic valve-in-valve implantation (ViV TAVI) represents a new treatment option for patients with degenerated aortic bioprosthesis. Comparative data to redo surgical aortic valve replacement (redo SAVR) are limited.
Objective
We investigated feasibility and outcome of ViV TAVI versus redo SAVR in patients with symptomatic degenerated Medtronic Freestyle aortic bioprosthesis (FSB).
Methods
Between January 2002 and February 2020, 25 patients with failed FSB underwent ViV TAVI and 10 patients with failed FSB underwent redo SAVR. Endpoints were defined according to the Valve Academic Research Consortium-2 (VARC-2) criteria.
Results
Age and logistic EuroSCORE II were higher in patients with ViV TAVI (75.4 ± 1.7 vs. 62.9 ± 5.1 years, p = .019; 11.5 ± 1.6 vs. 5.6 ± 5.6%, p = .007). Valve implantation was successful in all cases. Mean transvalvular pressure gradients were significantly lower in patients with redo SAVR than ViV TAVI (7.6 ± 1.0 vs. 10.3 ± 0.8 mmHg, p = .037). Aortic valve regurgitation was absent in 91% and 100% of patients with ViV TAVI and redo SAVR, respectively. Thirty-day mortality rates were 12% in the ViV TAVI cohort versus 0% in the redo SAVR cohort (p = .542). Within the first year after hospital discharge, one patient after ViV TAVI had redo surgical intervention.
Conclusions
ViV TAVI and redo SAVR lead to excellent functional results in patients with degenerated FSB. Post-procedural early complications must be considered particularly in patients with ViV TAVI because of higher clinical risk profiles.

© 2021 Wiley Periodicals LLC.

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

Histopathologic analysis of extracted thrombi from deep venous thrombosis and pulmonary embolism: Mechanisms and timing.

Silver MJ, Kawakami R, Jolly MA, Huff CM, ... Virmani R, Finn AV
Background
Mechanical thrombectomy is increasingly being used as an alternative to pharmacologic therapies for the treatment of patients with acute deep venous thrombosis (DVT) and pulmonary embolism (PE) and allows direct histopathologic comparison of thrombi extracted from living patients. We performed histopathologic analysis to thrombi extracted from cases of DVT and PE to gain insights into their relative cellular compositions.
Methods
Thrombus retrieved using a catheter-based thrombectomy system (ClotTriever for lower extremity DVT and FlowTriever for PE) from the 17 patients (7 DVT cases and 10 PE cases) were histologically evaluated. Histological features were used to estimate their age and pathological characteristics.
Results
The thrombus in all cases were composed of fibrin, platelets, red blood cells, and acute inflammatory cells. The weights of thrombus obtained from DVT versus PE cases were heavier (DVT 7.2 g (g) (5.6-10.2) vs. PE 4.8 g (3.6-6.8), p = .01). Overall thrombus healing (i.e., thrombus composed of smooth muscle cells, endothelial cells, and proteoglycans) was different between DVT and PE cases. 6/7 (86%) with features of late stage healing were from DVT cases while only three of ten (30%) were from PE cases while PE contained more acute thrombi with 7/10 (70%) stage 2 as compared 1/7 (14%) for DVT (p = .0498).
Conclusion
This study is the first to directly compare the histology of extracted thrombus in DVT versus PE cases from patients with clinical events. Overall PE cases demonstrated significantly earlier stage thrombus with a larger component of red blood cells.

© 2021 Wiley Periodicals LLC.

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

Antegrade and retrograde in-stent tibial artery chronic total occlusion recanalization with double kiss crush (DK crush) stenting of previous stent.

Memon S, George JC, Kalra S, Janzer S
Below the knee (BTK) peripheral arterial disease often presents with critical limb ischemia (CLI) clinically with involvement of more than one tibial vessels. Drug eluting stent (DES) technology for treatment of BTK disease has shown promising long-term durable results; however, currently only coronary DESs are available for application in the United States. Although coronary bifurcation stenting techniques are backed by extensive data in literature, there is a scarcity of data for the treatment of tibial bifurcation disease. Bifurcation angles in the tibials are similar to those in the coronaries and therefore the same two stent bifurcation technique can be applied in BTK disease. Double Kiss crush (DK crush) stenting has superior outcomes when compared to provisional or culotte stenting in randomized coronary trials (based on Medina classification). We present a case of BTK CLI with tibial bifurcation chronic total occlusion treated with two stent DK crush technique using coronary DES.

© 2021 Wiley Periodicals LLC.

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

Clinical outcomes of patients with and without chronic kidney disease undergoing endovascular revascularization of infrainguinal peripheral artery disease: Insights from the XLPAD registry.

Kabir R, Vuppala S, Liu Y, Tejani I, ... Shishehbor MH, Banerjee S
Objectives
The purpose of the present study was to define clinical outcomes of chronic kidney disease (CKD) patients undergoing endovascular revascularization of infrainguinal peripheral artery disease (PAD).
Background
CKD is an established predictor of advanced PAD. However, clinical outcomes for these patients following endovascular revascularization remain inadequately defined.
Methods
Using the ongoing multicenter Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851), we analyzed all-cause death, target limb amputation, and need for repeat revascularization for patients with and without CKD undergoing infrainguinal endovascular revascularization between the years 2005 and 2018.
Results
Of 3,699 patients, 15.1% (n = 559) had baseline CKD. CKD patients had significantly higher incidence of heavily calcified lesions (48.4% vs. 38.1%, p < .001) and diffuse disease (66.9% vs. 61.5%, p = .007). Kaplan-Meier analysis showed significant differences between CKD and non-CKD patient outcomes at 12 months for freedom from target limb amputation (79.9% vs. 92.7%, p < .001) and all-cause death (90.1% vs. 97.6%, p < .001). However, freedom from target vessel revascularization was similar between the groups. After adjusting for baseline comorbidities in the CKD and non-CKD groups, the hazard ratios for target limb amputation and death at 12 months were 2.28 (95% confidence interval or CI 1.25-4.17, p < .001) and 4.38 (95% CI 2.58-7.45, p < .001), respectively.
Conclusions
Following endovascular revascularization for infrainguinal PAD, CKD was an independent predictor of all-cause death and target limb amputation at 12 months.

© 2021 Wiley Periodicals LLC.

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

In-hospital outcomes of transcatheter mitral valve repair in patients with and without end stage renal disease: A national propensity match study.

Khan MZ, Zahid S, Khan MU, Kichloo A, ... Munir MB, Balla S
Objectives
To study trends of utilization, outcomes, and cost of care in patients undergoing undergoing transcatheter mitral valve repair (TMVr) with end-stage renal disease (ESRD).
Background
Renal disease has been known to be a predictor of poor outcome in patients with mitral valve disease. Outcome data for patients with ESRD undergoing TMVr remains limited. Therefore, our study aims to investigate trends of utilization, outcomes, and cost of care among patients with ESRD undergoing TMVr.
Methods
We analyzed NIS data from January 2010 to December 2017 using the ICD-9-CM codes ICD-10-CM to identify patients who underwent TMVr. Baseline characteristics were compared using a Pearson ????² test for categorical variables and independent samples t-test for continuous variables. Propensity matched analysis was done for adjusted analysis to compare outcomes between TMVr with and without ESRD. Markov chain Monte Carlo was used to account for missing values.
Results
A total of 15,260 patients (weighted sample) undergoing TMVr were identified between 2010 and 2017. Of these, 638 patients had ESRD compared to 14,631 patients who did not have ESRD. Adjusted in-hospital mortality was lower in non-ESRD group (3.9 vs. <1.8%). Similarly, ESRD patients were more likely to have non-home discharges (85.6 vs. 74.9%). ESRD patients also had a longer mean length of stay (7.9 vs. 13.5 days) and higher mean cost of stay ($306,300 vs. $271,503).
Conclusion
ESRD is associated with higher mortality, complications, and resource utilization compared to non-ESRD patients. It is important to include this data in shared decision-making process and patient selection.

© 2021 Wiley Periodicals LLC.

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

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

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

© 2021 Wiley Periodicals LLC.

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

Low hemoglobin predicts high-platelet reactivity and major cardiovascular ischemic events at long-term follow-up among ACS patients receiving dual antiplatelet therapy with ticagrelor.

Verdoia M, Rolla R, Pergolini P, Gioscia R, ... De Luca G, Novara Atherosclerosis Study Group (NAS)
Background
Reduced levels of hemoglobin (Hb) represent an established marker of impaired outcomes and increased cardiovascular risk in patients with coronary artery disease, challenging the management of dual antiplatelet therapy (DAPT). However, while anemia has emerged as an independent predictor of suboptimal platelet inhibition in patients receiving clopidogrel, no study has so far evaluated the impact of Hb levels on high-on treatment platelet reactivity (HRPR) with ticagrelor and their prognostic consequences, that were the aim of the present study.
Methods
Patients on DAPT with ASA + Ticagrelor (90 mg/twice a day) after percutaneous coronary revascularization for ACS were scheduled for platelet function assessment 30-90 days post-discharge. Aggregation tests were performed by multiple electrode aggregometry. Suboptimal platelet inhibition (HRPR-high residual platelet reactivity was defined if above the lower limit of normality (417 AU*min). The primary study endpoint was defined as the occurrence of major cardiovascular events (a composite of cardiovascular death, recurrent acute coronary syndrome [MI], target vessel revascularization) at longest available follow-up.
Results
We included 397 patients that were divided according to tertiles values of Hb (< 12.7, 12-7-14.09, ≥14.1 g/dl). Patients with lower Hb were older and displayed a more severe cardiovascular risk profile. Mean levels of platelet reactivity were enhanced in patients with lower Hb after stimulation with TRAP peptide (TRAP test, p = .03) and ADP (p = .02). Elevated platelet reactivity (HRPR) on Ticagrelor was more frequent among patients with reduced Hb (16.4% vs. 12% vs. 5.4%, p = .005, adjusted OR [95%CI] = 1.71[0.996;3.01], p = .056). At a mean follow-up of 820.9 ± 553.4 days, 21.4% of the patients experienced the primary composite endpoint, with a higher rate of events in patients with lower Hb (27.6% vs. 22.6% vs. 13.5%, p = .006, adjusted HR [95%CI] = 1.51[1.12; 2.03], p = .006), mainly driven by a higher rate of recurrent ACS. After correction for baseline differences lower Hb tertiles but not HRPR emerged as independent predictor of MACE (adjusted HR [95%CI] = 0.98[0.50; 1.92], p = .95).
Conclusions
In the present study, we demonstrated that among patients on DAPT with ASA and ticagrelor after PCI for ACS, lower Hb levels are independently associated with a higher rate of HRPR and an increased rate of major ischemic events, and especially for recurrent ACS, although with no impact on survival. Neutral prognostic effect of HRPR was observed across Hb tertiles.

© 2021 Wiley Periodicals LLC.

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

QRS duration is a risk indicator of adverse outcomes after MitraClip.

Sugiura A, Weber M, Tabata N, Goto T, ... Nickenig G, Sinning JM
Background
While QRS duration is a known marker of left ventricular (LV) function, little is known about its utility for predicting clinical prognosis after transcatheter mitral valve repair (TMVR). We investigated the association between QRS duration and one-year adverse events after TMVR with the MitraClip system.
Methods
From January 2011 through April 2019, we identified consecutive patients who underwent TMVR. Patients who had prior cardiac resynchronization therapy or a ventricular pacing rhythm were excluded. The patients were divided into two groups according to their QRS duration (<120 or ≥ 120 ms). Cox proportional hazard model was applied to determine the association between QRS duration and the composite outcome (all-cause mortality and re-hospitalization due to heart failure) within 1 year.
Results
A total of 348 patients were analyzed. Prolonged QRS duration (≥120 ms) was associated with an increased risk of the composite outcome (adjusted-HR 2.35, 95%CI 1.30-4.24, p = .005). There was a linear relationship between prolonged QRS duration and the increased risk of the composite outcomes. The observed association was consistent both in patients with left ventricular ejection fraction ≤35% and those with >35%. Furthermore, a QRS duration ≥120 ms was associated with lower improvement of LVEF at follow-up (adjusted-β coefficient - 5.31%, 95%CI -8.17 to -2.46, p < .001).
Conclusions
Prolonged QRS duration was associated with an increased risk of mortality and re-hospitalization and less improvement of LVEF following TMVR. QRS duration could be a useful marker to predict adverse outcomes and LV function after TMVR.

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

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

Virtual support for remote proctoring in TAVR during COVID-19.

Arslan F, Gerckens U
Objectives
The current report describes a single operator\'s experience of the first use of smartglass technology as a facilitator of virtual support during TAVR proctoring.
Background
Restricted gatherings and containment measures during the ongoing COVID-19 pandemic have a major impact on daily clinical practice. Interaction between peers is crucial in science, clinical practice, and education. In addition, there is also a growing importance of proctoring in interventional cardiology for structural heart disease. Virtual support may facilitate the wide implementation of remote proctoring.
Methods
A collaboration between a smartglass provider (Rods & Cones) and self-expandable transcatheter aortic heart valve system (Medtronic) was initiated and tested extensively prior to TAVR procedures. Two cases were randomly selected for remote support. The light-weight smartglass consisted of a full HD central camera, a 720p ×5 optical zoom camera, built-in LED light, speaker and earphone jack, and an external visor to project data in a nonobstructive manner in the operators\' view.
Results
Preprocedural detailed discussion of the cases between the proctor and the operator occurred via teleconferencing. Successful procedural virtual support was determined by the presence of a session coordinator, high quality of the central camera, high-speed and stable wireless internet connection. Limitations were the relative discomfort of the earpieces, discordance between the central and zoom camera and the absence of visual fixation during head motions.
Conclusion
In a highly complex and demanding context such as TAVR, remote proctoring by means of virtual support is feasible and efficacious.

© 2021 Wiley Periodicals LLC.

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

Increasing stroke events in patients with ST elevation myocardial infraction and cardiogenic shock: A cause for concern.

Kayani WT, Jneid H
The incidence of stroke in patients with STEMI complicated by cardiogenic shock (CS) is much higher than in those without CS. Use of percutaneous Mechanical Circulatory Support (MCS) is associated with a higher incidence of stroke in these patients; however, a causal relationship cannot be inferred. Careful attention should be given to stroke mitigation and management strategies in this cohort and judicious use of MCS is warranted. Future prospective clinical studies are needed to examine the impact of MCS on stroke incidence in these patients and further validate these clinically important findings.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Jan 2021; 97:226-227

Hemodynamic compromise in pulmonary embolism: \"A tale of two ventricles\".

Bowers T, Goldstein JA
In acute pulmonary embolism (PE), low cardiac output (CO)-hypotension results from disparate ventricular conditions: The left ventricle (LV) is under-filled and contracting vigorously, whereas the right ventricle (RV) is failing and dilated. The proximate cause of LV preload deprivation is thrombus-induced pulmonary vascular obstruction; abruptly increased pulmonary vascular resistance (PVR) induces acute RV systolic dysfunction which further compromises trans-pulmonary flow. \"Escalation of Care\" interventions (thrombolytics and aspiration thrombectomy) improve systemic hemodynamics by increasing LV preload delivery directly by reducing PVR and indirectly by relief of the strained failing RV.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Jan 2021; 97:299-300

How strong is the warranty of a negative FFR? Comment on long-term outcome after deferred revascularization due to negative fractional flow reserve in intermediate coronary lesions by Weerts et al.

Kern MJ, Seto AH
Outcomes of deferred PCI based on negative FFR are generally good. This study demonstrated deferred target lesion failure with FFR >0.80 in 7% and related it to coexistent risk factors, such as multivessel disease, diabetes, and SVG lesions. A negative FFR is only one variable on the continuum of ischemic risk, but in general provides an excellent prognostic tool.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Jan 2021; 97:257-258

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

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

© 2021 Wiley Periodicals LLC.

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