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 device. Two patients with L-loop transposition of the great arteries each successfully underwent placement of two MitraClip XT 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: 07 Sep 2020; epub ahead of print

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

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

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 15 Nov 2020; epub ahead of print

Association of heart failure duration with clinical outcomes after transcatheter mitral valve repair for functional mitral regurgitation.

Sugiura A, Weber M, Tabata N, Goto T, ... Nickenig G, Sinning JM
Background
Little is known about the association of heart failure (HF) chronicity with clinical outcomes after transcatheter mitral valve repair (TMVR) for functional mitral regurgitation (MR).
Methods
From January 2011 to March 2019, consecutive patients with functional MR who underwent a MitraClip procedure were analyzed. The patients were divided into two groups according to HF duration-those with duration ≤18 months and those with >18 months. The primary outcome measure was a composite of all-cause mortality and re-HF rehospitalization within 1 year after the procedure. These outcomes were also assessed separately. A Cox proportional hazard model was conducted for investigating the association of HF duration with the primary outcome.
Results
A total of 208 patients were analyzed. Patients with HF duration >18 months had a higher rate of the primary outcome compared to those with HF duration ≤18 months (38.1 vs. 19.0%, log-rank p = .003). A longer duration of HF was associated with an increased risk of the primary outcomes (adjusted-HR of >18 months, 2.12 95% CI, 1.14-4.19; p = .03; adjusted-HR (hazard ratios) for 1 year increase, 1.05; 95% CI, 1.02-1.09; p = .004). The association of HF duration with the primary outcomes showed a steep rise during the first 2 years of HF duration and progressive increase after 5 years.
Conclusions
A longer HF duration before TMVR was associated with an increased risk of all-cause mortality or HF rehospitalization. HF duration can be used for the risk stratification marker in patients undergoing TMVR for functional MR.

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

Catheter Cardiovasc Interv: 18 Nov 2020; epub ahead of print

Transcatheter aortic valve replacement and percutaneous coronary intervention versus surgical aortic valve replacement and coronary artery bypass grafting in patients with severe aortic stenosis and concomitant coronary artery disease: A systematic review and meta-analysis.

Kotronias RA, Bray JH, Scarsini R, Rajasundaram S, ... Bagur R, Banning AP
Objectives
We performed a systematic review and meta-analysis to evaluate the early and midterm outcomes of patients who underwent surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG) against patients who had transcatheter aortic valve replacement (TAVR) and percutaneous coronary intervention (PCI).
Background
Contemporary guidelines suggest that surgical or percutaneous revascularization of significant coronary artery disease (CAD) in patients with severe aortic stenosis (AS) is a reasonable strategy.
Methods
We conducted a comprehensive search of Medline and Embase to identify studies comparing a percutaneous transcatheter versus a surgical approach. Random effects meta-analyses using the Mantel-Haenszel method were performed to estimate the effect of percutaneous compared surgical strategies using aggregate data.
Results
Six studies reporting on 1770 participants were included in the meta-analysis. There were no significant differences in effect estimates for early and midterm mortality (OR: 0.78; 95% CI, 0.50-1.20 and OR: 1.09; 95% CI, 0.80-1.49, respectively) or myocardial infarction (OR: 0.52; 95% CI, 0.20-1.33 and OR: 1.34; 95% CI, 0.67-2.65, respectively). No significant difference was shown for peri-procedural stroke (OR: 0.80; 95% CI, 0.35-1.87). A transcatheter approach had a higher rate of major vascular complications (OR: 14.44; 95% CI, 4.42-47.16), but a lower rate of acute kidney injury (OR: 0.41; 95% CI, 0.19-0.91).
Conclusion
Our analysis suggests that a percutaneous transcatheter approach confers similar outcomes compared to a surgical approach in patients with severe AS and CAD. However, our findings are based on low quality studies and should serve as hypothesis generating. In the absence of adequately powered studies yielding high level evidence, individualized decision making should be based on surgical risk assessment.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Oct 2020; 96:1113-1125

Impact of the COVID-19 pandemic on interventional cardiology training in the United States.

Shah S, Castro-Dominguez Y, Gupta T, Attaran R, ... Mahmud E, Applegate RJ
Objectives
We sought to determine the effect of COVID-19 related reduction in elective cardiac procedures and acute coronary syndrome presentations on interventional cardiology (IC) training.
Background
The COVID-19 pandemic has significantly disrupted healthcare in the United States, including cardiovascular services. The impact of COVID-19 on IC fellow training in the United States has not been assessed.
Methods
The Society for Cardiovascular Angiography and Interventions (SCAI) surveyed IC fellows training in both accredited and advanced non-accredited programs, as well as their program directors (PD).
Results
Responses were received from 135 IC fellows and 152 PD. All respondents noted reductions in procedural volumes beginning in March 2020. At that time, only 43% of IC fellows had performed >250 PCI. If restrictions were lifted by May 15, 2020 78% of IC fellows believed they would perform >250 PCI, but fell to only 70% if restrictions persisted until the end of the academic year. 49% of IC fellows felt that their procedural competency was impaired by COVID-19, while 97% of PD believed that IC fellows would be procedurally competent at the end of their training. Most IC fellows (65%) noted increased stress at work and at home, and many felt that job searches and/or existing offers were adversely affected by the pandemic.
Conclusion
The COVID-19 pandemic has substantially affected IC training in the United States, with many fellows at risk of not satisfying current program procedural requirements. These observations support a move to review current IC program requirements and develop mitigation strategies to supplement gaps in education related to reduced procedural volume.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Oct 2020; 96:997-1005

Cardiac procedural deferral during the coronavirus (COVID-19) pandemic.

Yong CM, Ang L, Welt FGP, Gummidipundi S, ... Fearon WF,

We aimed to examine factors impacting variability in cardiac procedural deferral during the COVID-19 pandemic and assess cardiologists\' perspectives regarding its implications. Unprecedented cardiac procedural deferral was implemented nationwide during the COVID-19 pandemic. A web-based survey was administered by Society for Cardiovascular Angiography and Interventions and the American College of Cardiology Interventional Council to cardiac catheterization laboratory (CCL) directors and interventional cardiologists across the United States during the COVID-19 pandemic. Among 414 total responses, 48 states and 360 unique cardiac catheterization laboratories were represented, with mean inpatient COVID-19 burden 16.4 ± 21.9%. There was a spectrum of deferral by procedure type, varying by both severity of COVID-19 burden and procedural urgency (p < .001). Percutaneous coronary intervention volumes dropped by 55% (p < .0001) and transcatheter aortic valve replacement volumes dropped by 64% (p = .004), with cardiologists reporting an increase in late presenting ST-elevation myocardial infarctions and deaths among patients waiting for transcatheter aortic valve replacement. Almost 1/3 of catheterization laboratories had at least one interventionalist testing positive for COVID-19. Salary reductions did not influence procedural deferral or speed of reinstituting normal volumes. Pandemic preparedness improved significantly over time, with the most pressing current problems focused on inadequate testing and staff health risks. During the COVID-19 pandemic, cardiac procedural deferrals were associated with procedural urgency and severity of hospital COVID-19 burden. Yet patients did not appear to be similarly influenced, with cardiologists reporting increases in late presenting ST-elevation myocardial infarctions independent of local COVID-19 burden. The safety and importance of seeking healthcare during this pandemic deserves emphasis.

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

Catheter Cardiovasc Interv: 30 Oct 2020; 96:1080-1086

Transcatheter aortic valve implantation (TAVI) in cardiogenic shock: TAVI-shock registry results.

Fraccaro C, Campante Teles R, Tchétché D, Saia F, ... Chieffo A, Tarantini G
Objectives
Aim of this study is to evaluate safety, feasibility, and mid-term outcome of transcatheter aortic valve implantation (TAVI) in cardiogenic shock (CS).
Background
Balloon aortic valvuloplasty in patients with severe aortic valve stenosis (SAS) complicated by CS is indicated but associated with a grim prognosis. TAVI might be a more reasonable treatment option in this setting but data are scant.
Methods
From March 2008 to February 2019, 51 patients with severe aortic valvulopathy (native SAS or degenerated aortic bioprosthesis) and CS treated by TAVI in 11 European centers were included in this multicenter registry. Demographic, clinical, and procedural data were collected, as well as clinical and echocardiographic follow-up.
Results
The mean age of our study population was 75.8 ± 13, 49% were women, and mean Society of Thoracic Surgeons (STS) score was 19 ± 15%. Device success was achieved in 94.1%, with a 5% incidence of moderate/severe paravalvular leak. The 30-day events were mortality 11.8%, stroke 2.0%, vascular complications 5.9%, and acute kidney injury 34%. Valve Academic Research Consortium-2 early safety endpoint was reached in 35.3% of cases. At 1-year of follow-up, the mortality rate was 25.7% and the readmission for congestive heart failure was 8.6%.
Conclusions
TAVI seems to be a therapeutic option for patients with CS and SAS or degenerated aortic bioprosthesis in terms of both safety and efficacy at early and long-term follow-up.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Oct 2020; 96:1128-1135

Long-term follow-up of percutaneous coronary intervention versus coronary artery bypass grafting in left main coronary artery disease: A systematic review and meta-analysis.

Garg A, Rout A, Raheja H, Hakeem H, Sharma S
Objectives
We conducted a systematic review and meta-analysis to evaluate the long-term outcomes of PCI compared to CABG in patients with LMCAD.
Background
Recent data from randomized controlled trials (RCTs) has raised concerns regarding the long-term efficacy and safety of percutaneous coronary intervention (PCI) compared with coronary artery bypass grafting (CABG) in patients with left main coronary artery disease (LMCAD).
Methods
We searched MEDLINE and EMBASE databases for published RCTs comparing PCI using stenting with CABG in patients with LMCAD. Preferred reporting items for systematic review and meta-analysis guidelines were used for the present study. End-points of interest were all-cause mortality, cardiovascular (CV) mortality, myocardial infarction (MI), stroke, and repeat revascularization at longest available follow-up. Relevant data were collected and pooled odds ratio (OR) with 95% confidence intervals (CI) was calculated using random-effects model.
Results
Five RCTs including a total of 4,499 patients were included in the final analysis. Mean duration of follow-up was 96 months. The risks of all-cause mortality [OR 1.09 (95% CI 0.88-1.34)] and cardiovascular mortality [1.14 (0.88-1.47)] were comparable between PCI and CABG. There were no statistically significant differences between PCI and CABG for MI [1.52 (0.98-2.37)] and stroke [0.84 (0.48-1.45)]. Conversely, repeat revascularization was significantly higher with PCI as compared with CABG [1.82 (1.49-2.22)].
Conclusion
At long-term follow-up, PCI is associated with similar risks of mortality but a higher risk of repeat revascularization compared with CABG in LMCAD. Long-term risk of MI with PCI compared to CABG needs to be further explored in future studies.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 25 Oct 2020; epub ahead of print

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

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

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 23 Oct 2020; epub ahead of print

Antegrade transseptal transcatheter aortic valve replacement: Back to the future?

Misumida N, Anderson JH, Greason KL, Rihal CS

Antegrade transseptal approach was utilized in the first human case of transcatheter aortic valve replacement (TAVR) and in the early phase of TAVR. Various challenges with the antegrade transseptal approach including procedural complexity, need for atrial septal crossing, and potential for injury to the mitral valve apparatus led it to being supplanted by other approaches. These challenges have now largely been mitigated as structural interventionalists routinely perform left atrial procedures. We report a case of antegrade transseptal TAVR using a large bore sheath placed in the mid left ventricle across the mitral orifice to protect the mitral valve apparatus and facilitate valve deployment. An 84-year-old man with heart failure symptoms was seen for severe aortic stenosis. The severity of peripheral arterial disease precluded femoral, axillary, carotid, or transcaval routes. After transseptal puncture and creation of an arteriovenous rail, a long 26-Fr sheath was advanced from the right femoral vein transseptally over the arteriovenous rail, past the mitral valve inflow to the mid left ventricular cavity. The sheath provided a stable platform with stable intraprocedure hemodynamics. Balloon valvuloplasty was performed in an antegrade manner, after which a 29-mm SAPIEN S3 prosthesis was advanced into the aortic valve position and deployed under rapid pacing. We observed no injury to the mitral leaflets or subvalvular apparatus after the procedure. The antegrade transseptal approach should be revisited as an option for patients at high surgical risk with no other suitable access site. The use of a large bore sheath facilitates this approach.

© 2020 Wiley Periodicals, Inc.

Catheter Cardiovasc Interv: 30 Oct 2020; 96:E552-E556

European Bifurcation Club white paper on stenting techniques for patients with bifurcated coronary artery lesions.

Burzotta F, Lassen JF, Louvard Y, Lefèvre T, ... Serruys P, Stankovic G
Background
Defining the optimal conduction of percutaneous-coronary-intervention (PCI) to treat bifurcation lesions has been the subject of many clinical studies showing that the applied stenting technique may influence clinical outcome. Accordingly, bifurcation stenting classifications and technical sequences should be standardized to allow proper reporting and comparison.
Methods
The European Bifurcation Club (EBC) is a multidisciplinary group dedicated to optimize the treatment of bifurcations and previously created a classification of bifurcation stenting techniques that is based on the first stent implantation site. Since some techniques have been abandoned, others have been refined and dedicated devices became available, EBC promoted an international task force aimed at updating the classification of bifurcation stenting techniques as well as at highlighting the best practices for most popular techniques. Original descriptive images obtained by drawings, bench tests and micro-computed-tomographic reconstructions have been created in order to serve as tutorials in both procedure reporting and clinical practice.
Results
An updated Main-Across-Distal-Side (MADS)-2, classification of bifurcation stenting techniques has been realized and is reported in the present article allowing standardized procedure reporting in both clinical practice and scientific studies. The EBC-promoted task force deeply discussed, agreed on and described (using original drawings and bench tests) the optimal steps for the following major bifurcation stenting techniques: (a) 1-stent techniques (\"provisional\" and \"inverted provisional\") and (b) 2-stent techniques (\"T/TAP,\" \"culotte,\" and \"DK-crush\").
Conclusions
The present EBC-promoted paper is intended to facilitate technique selection, reporting and performance for PCI on bifurcated lesions during daily clinical practice.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Oct 2020; 96:1067-1079

Paclitaxel exposure: Long-term safety and effectiveness of a drug-coated balloon for claudication in pooled randomized trials.

Schneider PA, Brodmann M, Mauri L, Laird J, ... Ouriel K, Zeller T
Background
Paclitaxel drug-coated balloons (DCB) prevent recurrent claudication after angioplasty, yet data from randomized trials with incomplete follow-up have raised uncertainty regarding long-term mortality.
Objectives
To evaluate the effect of paclitaxel exposure on the long-term safety and efficacy of angioplasty of femoropopliteal artery lesions in the combined IN.PACT randomized trials.
Methods
The IN.PACT randomized trials (SFA, N = 331 and Japan, N = 100) each compared the DCB with standard percutaneous transluminal angioplasty (PTA) for claudication, and consented patients for 5 and 3 years, respectively. To address long-term safety, sites were requested to obtain vital status follow-up. In the pooled, updated data set, we examined the association between randomized treatment and mortality by cumulative incidence and hazard ratio (HR), and freedom from clinically driven target lesion revascularization (CD-TLR). Multivariable Cox regression with adjustment for baseline characteristics was used to evaluate the dose effect. Causes of death were adjudicated by a blinded clinical events committee that included oncologists with paclitaxel expertise.
Results
The rate of long-term vital status ascertainment increased from 81% to 97% for DCB and from 85% to 97% for PTA in the IN.PACT SFA trial. The cumulative incidence of mortality was 14.7% DCB versus 12.0% PTA at 5 years, HR 1.39, log-rank p = .286. Paclitaxel dose (mg) was not an independent predictor of mortality (HR 1.02, p = .381), but was an independent predictor of reduced risk of CD-TLR (HR 0.79; p < .001). Causes of death did not differ by treatment arm.
Conclusions
In pooled randomized trial data with updated vital status ascertainment, paclitaxel was associated with improved efficacy but was not associated with increased mortality.

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

Catheter Cardiovasc Interv: 30 Oct 2020; 96:1087-1099

Transcatheter versus surgical aortic valve replacement in patients with end stage renal disease.

Khan MZ, Khan MU, Kalra A, Krupica T, Kaluski E, Khan SU
Objective
To assess contemporary national trends of comorbidities, outcomes, and health care resource utilization in patients with aortic stenosis (AS) and end-stage renal disease (ESRD) undergoing transcatheter and surgical aortic valve replacement (TAVR and SAVR).
Methods and results
The National-Inpatient-Sample was used to study trends in patients with AS and ESRD undergoing TAVR and SAVR between January 2012 and December 2017. Of 12,550 patients, 5,735 underwent TAVR and 6,815 underwent SAVR. Over the years, the utilization of SAVR declined (from 82.0 to 37.7%); and increased for TAVR (from 18.0 to 62.3%; p < .001). Patients receiving TAVR were older (74.6 [9.1] vs. 66.8 years [9.1]), had a higher proportion of females (37.1 vs. 32.5%), Caucasians (68.7 vs. 60.9%) and Asian /Pacific Islanders (3.1 vs. 2.7%; p < .001 for all). The TAVR patients, despite having higher comorbidity burden (anemia, coronary artery disease, chronic pulmonary disease, congestive heart failure, cerebrovascular disease, and peripheral vascular disease) had lower inpatient mortality and complications (ST-elevation myocardial infarction, pneumonia, pneumothorax, pulmonary embolism, cardiogenic shock, cardiac arrest, and need for mechanical ventilators and vasopressors). The median length of stay (13.9-6.5 days; p < .001) and cost of stay ($311,538.16 to $255,693.40; p < .001) reduced with TAVR; but remained unchanged with SAVR. Higher proportion of patients was discharged home after TAVR vs. SAVR.
Conclusion
Among patients with AS and ESRD, despite providing therapy to subjects with higher comorbidity burden, TAVR was associated with lower inpatient mortality, complications, length of stay, cost of care, and higher home disposition rates when compared with SAVR.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Oct 2020; 96:1102-1109

Intermediate procedural and health status outcomes and the clinical care pathways after chronic total occlusion angioplasty: A report from the OPEN-CTO (outcomes, patient health status, and efficiency in chronic total occlusion hybrid procedures) study.

Sapontis J, Hirai T, Patterson C, Gans B, ... Grantham JA, Salisbury AC
Background
No previous reports have described the comprehensive care pathways involved in chronic total occlusion percutaneous coronary intervention (CTO PCI).
Methods
In a study of 1,000 consecutive patients undergoing CTO PCI using hybrid approach, a systematic algorithm of selecting CTO PCI strategies, the procedural characteristics, complication rates, and patient reported health status outcomes through 12 months were assessed.
Results
Technical success of the index CTO PCI was 86%, with 89% of patients having at least one successful CTO PCI within 12 months. A total of 13.8% underwent CTO PCI of another vessel or reattempt of index CTO PCI within 1 year. At 1 year, the unadjusted major adverse cardiac and cerebral event (MACCE) rate was lower in patients with successful index CTO PCI compared to patients with unsuccessful index CTO PCI (9.4% vs. 14.6%, p = .04). The adjusted hazard ratios of myocardial infarction and death at 12 months were numerically lower in patients with successful index CTO PCI, compared to patients with unsuccessful index CTO PCI. Patients with successful index CTO PCI reported significantly greater improvement in health status throughout 12-months compared to patients with unsuccessful index CTO PCI.
Conclusion
CTO-PCI in the real-world often require treatment of second CTO, non-CTO PCI or repeat procedures to treat initially unsuccessful lesions. Successful CTO PCI is associated with numerically lower MACCE at 1 year and persistent symptomatic improvement compared to unsuccessful CTO PCI. Understanding the relationship between the care pathways following CTO PCI and health status benefit requires further study.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 26 Oct 2020; epub ahead of print

Utility of the dual antiplatelet therapy score to guide antiplatelet therapy: A systematic review and meta-analysis.

Mihatov N, Secemsky EA, Kereiakes DJ, Steg G, ... Shen C, Yeh RW
Background
The dual antiplatelet therapy (DAPT) score, one of the first prediction tools to attempt to uncouple bleeding and ischemic risk following percutaneous coronary intervention, can help guide antiplatelet duration after coronary intervention. Evaluating the generalizability of the score is important to understand its utility in clinical practice.
Methods
We conducted a systematic review and meta-analysis of studies that validated the DAPT score. A random effect meta-analysis was performed of ischemic and bleeding risk based on DAPT score. A secondary analysis assessed the risk of longer versus shorter P2Y inhibitor duration on ischemic and bleeding risk in randomized controlled trials of DAPT duration.
Results
We identified 10 patient cohorts involving 88,563 patients. Compared with a low DAPT score, a high DAPT score was associated with increased ischemic risk (RR: 1.62, 95% CI: 1.41-1.87) and reduced bleeding risk (RR: 0.80, 95% CI: 0.70-0.92). In three randomized trials of DAPT duration that contained information on the DAPT score, the relative risk of net adverse clinical events (combined ischemic and bleeding events) with longer duration of DAPT was 1.56 (95% CI: 0.77-3.19) for low DAPT score patients, and 0.86 (95% CI: 0.61-1.21) for high DAPT score patients (p = .14).
Conclusions
In this large meta-analysis, the DAPT score consistently stratified bleeding and ischemic risk in opposing directions across several different study populations. More evaluation is needed to understand if the effect of longer DAPT duration on NACE is modified by the DAPT score in current practice.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 27 Oct 2020; epub ahead of print

Three-year clinical outcomes of the absorb bioresorbable vascular scaffold compared to Xience everolimus-eluting stent in routine PCI in patients with diabetes mellitus-AIDA sub-study.

Kerkmeijer LSM, Tijssen RYG, Hofma SH, van der Schaaf RJ, ... de Winter RJ, Wykrzykowska JJ
Background
In this prespecified AIDA-trial sub-study we investigate the clinical performance of absorb bioresorbable vascular scaffold (BVS) compared to Xience everolimus-eluting stent (EES) in routine percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) at complete 3-year follow-up.
Methods and results
All 1,845 randomized patients were subdivided by medical history with DM or without DM. Of the 924 Absorb BVS patients, 171 (18.5%) patients had DM, of which 65 (38.0%) were treated with insulin (iTDM). Of the 921 Xience EES patients, 153 (16.6%) patients had DM, of which 45 (29.4%) were insulin-treated diabetes mellitus (iTDM). Target vessel failure (TVF), composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization, occurred in 18.7% of diabetic patients treated with Absorb patients versus in 18.0% patients treated with Xience EES (p = .840). In nondiabetics the rates of TVF were 12.3% in Absorb BVS versus 11.0% in Xience EES (p = .391). Definite/probable device thrombosis occurred more frequently in Absorb BVS compared to Xience EES in both diabetic and nondiabetic patients (4.8% versus 0.7%; p = .028 and 3.2% vs. 0.5%; p < .001, respectively).
Conclusions
In routine PCI practice, both Absorb BVS and Xience EES have worse clinical outcomes in diabetic patients as compared to nondiabetic patients. Throughout all clinical presentations, Absorb BVS was associated with higher rates of device thrombosis at 3-year follow-up.

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

Catheter Cardiovasc Interv: 28 Oct 2020; epub ahead of print

Prognostic impact of collaterals in patients with a coronary chronic total occlusion: A meta-analysis of over 3,000 patients.

Allahwala UK, Nour D, Bhatia K, Ward MR, ... Weaver JC, Bhindi R
Objectives
To assess the prognostic implications of the degree of coronary collaterals on outcomes in patients with a CTO.
Background
Coronary chronic total occlusions (CTO) are identified frequently in patients undergoing coronary angiography and have been associated with poorer prognosis. Whether the degree of coronary collaterals, the hallmark of CTOs impacts prognosis, is unknown.
Methods
A search of EMBASE, MEDLINE, and Cochrane Library was conducted to identify studies reporting on coronary collaterals and risk of all-cause mortality, acute myocardial infarction (AMI) and successful percutaneous coronary intervention (PCI). Patients with Rentrop grade 0 or 1 collaterals were defined as poor collaterals, while Rentrop grade 2 or 3 were defined as robust collaterals.
Results
Twelve studies with a total of 3,369 were included. Patients with robust collaterals did not have lower rates of AMI (OR: 0.89, 95%CI: 0.39-2.04) or lower rates of all-cause mortality (OR: 0.81, 95% CI: 0.42-1.58), however were more likely to have successful PCI (OR: 4.04, 95%CI: 1.10-14.85).
Conclusion
The presence of robust collaterals is not associated with lower rates of AMI or mortality, but does increase the likelihood of successful CTO PCI. These results have importance implications with respect to the indications for CTO PCI as well as selecting appropriate patients to undergo the procedure.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 28 Oct 2020; epub ahead of print

Transcatheter aortic valve replacement in aortic regurgitation: The U.S. experience.

Arora S, Lahewala S, Zuzek Z, Thakkar S, ... Attizzani GF, Panaich SS
Background
Transcatheter aortic valve replacement (TAVR) can be an effective option for high-risk Aortic Regurgitation (AR) patients. Although international experiences of TAVR for AR are published, U.S. data are limited. This study sought to report the short-term outcomes of TAVR in AR in the U.S.
Population

Methods
Study cohorts were derived from the Nationwide Inpatient Sample (NIS) and Nationwide Readmissions Database (NRD) 2016-17. TAVR and AR were identified using ICD-10-CM-codes. The key outcomes were all-cause mortality, disabling stroke, valvular complications, complete heart block (CHB)/permanent pacemaker placement (PPM), open-heart surgery, acute kidney injury (AKI) requiring dialysis, and vascular complications. Multivariate logistic regression was used to adjust for confounders.
Results
915 patients from the NIS (male-71%, age ≥65-84.2%) and 822 patients from the NRD (male-69.3%, age ≥65-80.5%) underwent TAVR for AR. The median length of stay (LOS) was 4 days for both cohorts. In-hospital mortality was 2.7%, and 30-day mortality was 3.3%. Disabling strokes were noted in 0.6% peri-procedurally and 1.8% at 30-days. Valve-related complications were 18-19% with paravalvular leak (4-7%) being the most common. Approximately 11% of patients developed CHB and/or needed PPM in both cohorts. In NRD, 2.2% of patients required dialysis for AKI, 1.5% developed vascular complications, and 0.6% required open-heart surgery within 30-days post-procedure. Anemia was predictive of increased overall complications and valvular complications, whereas peripheral vascular disease was a predictor of increased valvular complications and CHB/PPM.
Conclusion
TAVR is a promising option in AR. Further studies are necessary for the expansion of TAVR as the standard treatment in AR.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Nov 2020; epub ahead of print

One-year safety and efficacy profile of transcatheter aortic valve-in-valve implantation with the portico system.

Casenghi M, Gorla R, Popolo Rubbio A, De Marco F, ... Testa L, Bedogni F
Objective
This study sought to investigate the procedural and mid-term outcomes of transcatheter aortic valve implantation for failed surgical bioprostheses (TAVI-ViV) with Portico device.
Background
Limited evidence coming from early experience on Portico system does not allow to fully assess safety and efficacy of this device in this ViV patients.
Methods
From January 2016 up to June 2019, 56 consecutive patients undergoing TAVI-ViV with Portico were prospectively included in our institutional TAVI database.
Results
The prevalent mechanism of failure was stenosis (58.9%); true internal diameter (ID) was <21 mm in 71.4% of cases. Device success rate were 69.6% with 14 (25%) patients showing a residual gradient ≥20 mmHg, 2 (3.6%) a PVL ≥ moderate and 1 (1.8%) required a second THV implantation due to device embolization. At 1-year follow-up 5 patients (8.9%) died whereas moderate SVD was reported in 2 (3.6%). Patients with a post-procedural mean gradient ≥20 mmHg showed a significantly higher rate of CV hospitalization (21.4% vs. 2.4%, p = .02) whereas no differences in procedural and 1-year outcomes were noticed according to true ID diameter or degeneration mode. Chimney stenting (ChT) was performed in 23 (41%) patients without significant differences in procedural and 1-year outcomes compared to non-ChT group.
Conclusions
TAVI-ViV with Portico valve was associated with good procedural and 1-year outcomes, even in patients with features of high procedural and anatomical complexity.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 05 Nov 2020; epub ahead of print

Long-term outcomes after transcatheter aortic valve replacement with minimal contrast in chronic kidney disease.

Rzucidlo J, Jaspan V, Paone D, Jilaihawi H, ... Shah B, Williams M
Background
Patients with renal insufficiency have poor short-term outcomes after transcatheter aortic valve replacement (TAVR).
Methods
Retrospective chart review identified 575 consecutive patients not on hemodialysis who underwent TAVR between September 2014 and January 2017. Outcomes were defined by VARC-2 criteria. Primary outcome of all-cause mortality was evaluated at a median follow-up of 811 days (interquartile range 125-1,151).
Results
Preprocedural glomerular filtration rate (GFR) was ≥60 ml/min in 51.7%, 30-60 ml/min in 42.1%, and < 30 ml/min in 6.3%. Use of transfemoral access (98.8%) and achieved device success (91.0%) did not differ among groups, but less contrast was used with lower GFR (23 ml [15-33], 24 ml [14-33], 13 ml [8-20]; p < .001). Peri-procedural stroke (0.7%, 2.1%, 11.1%; p < .001) was higher with lower GFR. Core lab analysis of preprocedural computed tomography scans of patients who developed a peri-procedural stroke identified potential anatomic substrate for stroke in three out of four patients with GFR 30-60 ml/min and all three with GFR <30 ml/min (severe atheroma was the most common subtype of anatomical substrate present). Compared to GFR ≥60 ml/min, all-cause mortality was higher with GFR 30-60 ml/min (HR 1.61 [1.00-2.59]; aHR 1.61 [0.91-2.83]) and GFR <30 ml/min (HR 2.41 [1.06-5.48]; aHR 2.34 [0.90-6.09]) but not significant after multivariable adjustment. Follow-up echocardiographic data, available in 63%, demonstrated no difference in structural heart valve deterioration over time among groups.
Conclusions
Patients with baseline renal insufficiency remain a challenging population with poor long-term outcomes despite procedural optimization with a transfemoral-first and an extremely low-contrast approach.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 11 Nov 2020; epub ahead of print

The state of renal sympathetic denervation for the management of patients with hypertension: A systematic review and meta-analysis.

Syed M, Osman M, Alhamoud H, Saleem M, ... Kawsara A, Daggubati R
Background
Sympathetic nervous system plays a central role in the development and persistence of essential hypertension. In recent years renal sympathetic denervation (RSD) has emerged as a promising option for the treatment of patients with hypertension.
Methods
We conducted a literature search of PubMed, EMBASE, Cochrane library and Clinicaltrials.gov from inception through April 20, 2020. Outcomes of interest were change in 24-hour ambulatory systolic (ASBP) or diastolic blood pressure (ADBP) and change in office systolic (OSBP) or diastolic blood pressure (ODBP). We pooled data from randomized controlled trials (RCTS) comparing RSD to sham procedures in the management of hypertension using the random effect model.
Results
A total of 1,363 patients from eight studies were included in the current meta-analysis. The mean age of the included patients was 56 ± 2.6 years, 29% were women and the median duration of maximum follow up was 6-month (range 3-12 month). There was more reduction favoring RSD in ASBP (Weighted mean difference [WMD] -3.55; 95% CI -4.91 - -2.19, p < .001, I = 0%), ADBP (WMD -1.87; 95% CI -3.07 - -0.66, p = .002, I = 43%), OSBP (WMD -5.5; 95% CI -7.59 - -3.40, p < .001, I = 7%) and ODBP (WMD -3.20; 95% CI -4.47 - -1.94, p < .001, I = 14%).
Conclusion
The use of RSD for the management of hypertension resulted in effective reduction in the ambulatory and office blood pressure compared to sham procedure. Adequately powered RCTs of RSD are needed to confirm safety, reproducibility and assess the impact on clinical outcomes.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 11 Nov 2020; epub ahead of print

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: 11 Nov 2020; epub ahead of print

One-year clinical and echocardiographic outcomes of direct implantation of a self-expanding valve.

Benetos G, Karmpalioti M, Drakopoulou M, Stathogiannis K, ... Tousoulis D, Toutouzas K
Objective
To present 1 year clinical and echocardiographic outcomes of the randomized DIRECT (Pre-dilatation in Transcatheter Aortic Valve Implantation Trial) trial.
Background
Intermediate-term data from randomized studies investigating the safety and efficacy of direct implantation are lacking.
Methods
DIRECT trial randomized 171 consecutive patients with severe aortic stenosis at four tertiary centers to undergo TAVI with the use of self-expanding prostheses with (pre-BAV) or without pre-dilatation (no-BAV). The primary endpoint was device success according to the VARC-2 criteria. All patients underwent a clinical and echocardiographic follow-up at 1 year. All-cause and cardiac mortality, stroke, heart failure hospitalization, and new pacemaker implantation were recorded.
Results
At 1 year, four deaths were recorded in pre-BAV group (4.7%) and three deaths in no-BAV group (3.5%). There was no difference in Kaplan-Meier plots between the two groups in all-cause mortality at 1 year (log-rank p = .72). Similarly, there was no difference in the incidence of permanent pacemaker implantation between the two groups at 1 year (27/67-40.3% in no-BAV group versus 20/69-29% in pre-BAV group, log-rank p = .24). There was no significant difference between pre-BAV and no BAV group in aortic valve area (1.84 ± 0.39 cm vs. 1.85 ± 0.44 cm , p = .90), mean aortic valve gradient (8.36 ± 5.04 vs. 8.00 ± 4.04 mmHg, p = .65) and moderate or severe paravalvular regurgitation (5-6.6 vs. 4-5.7%, respectively) at 1 year. The same applied independently from the performance of post-dilatation at baseline.
Conclusions
Direct, without pre-dilatation, implantation of a self-expanding valve has no impact on one-year clinical and echocardiographic outcomes, independently also from the baseline performance of post-dilatation.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 11 Nov 2020; epub ahead of print

Incidence and fate of device-related left pulmonary artery stenosis and aortic coarctation in small infants undergoing transcatheter patent ductus arteriosus closure.

Tomasulo CE, Gillespie MJ, Munson D, Demkin T, ... Rome JJ, Glatz AC
Objectives
To evaluate short- and middle-term outcomes after transcatheter patent ductus arteriosus (TC-PDA) closure in small infants, specifically device-related left pulmonary artery (LPA) stenosis and aortic coarctation, risk factors, and changes over time.
Background
Recent studies have demonstrated successful transcatheter PDA (TC-PDA) closure in small infants. LPA stenosis and aortic coarctation have been seen after TC-PDA, but it is not clear whether device-related LPA/aortic obstruction persists.
Methods
A single-center retrospective study of infants ≤4 kg who underwent TC-PDA closure from February 1, 2007 to September 1, 2018 was performed, evaluating the incidence and risk factors for LPA stenosis and coarctation.
Results
Forty-four patients underwent successful TC-PDA with Amplatzer Vascular Plug II (AVPII; n = 30), Amplatzer Duct Occluder II-Additional Sizes (n = 10), Amplatzer Duct Occluder I (n = 3), and coil-filled AVPI (n = 1) devices, all via an antegrade approach. Median birthweight and procedural weight were 890 g (range: 490-3,250) and 2.8 kg (range: 1.2-4.0), respectively. Median follow-up was 0.7 years (range: 2 days-7 years). Thirty-eight patients had post-procedure echocardiograms assessing LPA/aortic obstruction. Of those, 17 had LPA flow acceleration/stenosis (≥1.5 m/s), which improved or resolved in all patients with available follow-up; 3 developed mild coarctation (>2 m/s), which improved in the two with more than short-term follow-up; 4 developed mild flow acceleration (1.5-2 m/s) in the descending aorta, which resolved in three and increased in one (2.4 m/s). Flow acceleration in the LPA was associated with younger procedural age, larger PDA minimal diameter, and placement of a device other than the AVPII. There was no device-related mortality or need for reintervention.
Conclusion
TC-PDA in small infants is effective, without significant complications. Device-related LPA/aortic obstruction can improve with time/growth.

© 2020 Wiley Periodicals, Inc.

Catheter Cardiovasc Interv: 30 Sep 2020; 96:889-897

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 m .
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: 24 Sep 2020; epub ahead of print

Endovascular embolization of a lower limb arteriovenous fistula using a vascular plug deployed with a through-and-through arteriovenous access.

Grandi A, Melloni A, Chiesa R, Bertoglio L

A 66-year-old man was referred to our institution for a popliteal arteriovenous fistula (AVF). The patient presented with left lower limb edema associated with a pulsatile popliteal mass with bruit at auscultation, and no sign of lower limb ischemia. Relevant history included penetrating stabbing wound to that leg 50 years prior. A computed tomography scan demonstrated an AVF with a tract 10 mm in length and 6 mm in diameter at the level of the popliteal fossa. An AMPLATZER Vascular Plug III 12 mm (AVP - AGA Medical Corporation, Minneapolis, MN) was initially deployed through a percutaneous femoral arterial access. Initial angiographic check showed inadequate sealing, so the plug was repositioned from the venous side of the AVF with a through-and-through arteriovenous access from the posterior tibial vein, achieving a correct sealing. At 24-month follow-up the patient does not present any complications from the procedure, and the AVF remains occluded.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 01 Oct 2020; epub ahead of print

SCAI position statement on the performance of percutaneous coronary intervention in ambulatory surgical centers.

Box LC, Blankenship JC, Henry TD, Messenger JC, ... Rao SV, Mahmud E

The Centers for Medicare & Medicaid Services (CMS) began reimbursement for percutaneous coronary intervention (PCI) performed in ambulatory surgical centers (ASC) in January 2020. The ability to perform PCI in an ASC has been made possible due to the outcomes data from observational studies and randomized controlled trials supporting same day discharge (SDD) after PCI. In appropriately selected patients for outpatient PCI, clinical outcomes for SDD or routine overnight observation are comparable without any difference in short-term or long-term adverse events. Furthermore, a potential for lower cost of care without a compromise in clinical outcomes exists. These studies provide the framework and justification for performing PCI in an ASC. The Society for Cardiovascular Angiography and Interventions (SCAI) supported this coverage decision provided the quality and safety standards for PCI in an ASC were equivalent to the hospital setting. The current position paper is written to provide guidance for starting a PCI program in an ASC with an emphasis on maintaining quality standards. Regulatory requirements and appropriate standards for the facility, staff and physicians are delineated. The consensus document identified appropriate patients for consideration of PCI in an ASC. The key components of an ongoing quality assurance program are defined and the ethical issues relevant to PCI in an ASC are reviewed.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Sep 2020; 96:862-870

Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥700 grams.

Sathanandam SK, Gutfinger D, O\'Brien L, Forbes TJ, ... Nykanen DG, Zahn EM
Objectives
Characterize the safety and effectiveness of the Amplatzer Piccolo Occluder for patent ductus arteriosus (PDA) closure.
Background
The presence of a hemodynamically significant PDA has been associated with an increased risk of morbidity and mortality in children born premature.
Methods
This was a single arm, prospective, multicenter, non-randomized study to evaluate the Amplatzer Piccolo Occluder to treat PDA in patients ≥700 g. From June 2017 to February 2019, 200 patients were enrolled at nine centers, with 100 patients weighing ≤2 kg. Primary effectiveness endpoint was the rate of PDA closure at 6-month follow-up. Primary safety endpoint was the rate of major complications through 6 months. Secondary endpoint was rate of significant pulmonary or aortic obstruction through 6 months\' follow-up.
Results
The implant success rate was 95.5% (191/200) overall and 99% in patients ≤2 kg (99/100). The primary effectiveness endpoint was achieved in 99.4% of implanted patients. Four patients experienced a primary safety endpoint event (2 transfusions, 1 hemolysis, and 1 aortic obstruction). There were no branch pulmonary artery obstructions. Five patients, all ≤2 kg, were noted to have worsening of tricuspid regurgitation (TR) after the procedure. None of the TR incidences manifested clinically. The Amplatzer Piccolo Occluder received FDA approval in January 2019 and became the first device approved for PDA closure in patients ≥700 g.
Conclusions
This study supports the safety and effectiveness of the Amplatzer Piccolo Occluder, particularly in patients between 700 g and 2 kg where there is currently a significant unmet need in the United States. ClinicalTrials.gov identifier: NCT03055858.

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

Catheter Cardiovasc Interv: 30 Oct 2020; 96:1266-1276

The snared wire technique for Sapien valve implantation in the pulmonary position.

Maschietto N, Sperotto F, Esch JE, Porras D, Callahan R
Objectives
Description of the snared wire technique (SWT) to facilitate the delivery of the Sapien valve in pulmonary position, and comparison with standard delivery technique.
Background
Transcatheter pulmonary valve replacement (TPVR) with the Sapien delivery system has proven to be challenging. Therefore, alternative strategies for facilitating its delivery in this position are needed.
Methods
Retrospective analysis of patients who underwent TPVR with or without the new SWT. The SWT was chosen as an elective strategy when the anatomy was judged to be challenging for TPVR (planned SWT) or as a rescue strategy when a standard delivery failed (rescue SWT).
Results
From February 2018 to January 2020, 84 patients underwent TPVR with a Sapien S3 valve using either a standard delivery (n = 63, 75%) or a SWT (n = 21, 25%). Fifteen patients underwent a planned SWT, six patients underwent a rescue SWT after failure of a standard delivery. All planned SWT cases were successful and, compared to the standard delivery group, no significant differences were found in terms of time to valve-deployment, fluoroscopy time, procedure time, or frequency of complications. Rescue SWT cases had longer fluoroscopy time (p = .05), longer time to valve-deployment (p = .0001), and higher frequency of complications (p = .002) including tricuspid valve injury (p = .0004), but allowed the operator to successfully implant the valve into the desired location.
Conclusions
Even in the most challenging anatomies, the SWT represents a feasible and effective alternative strategy for TPVR with the Sapien valve that should be considered when other techniques have failed.

© 2020 Wiley Periodicals, Inc.

Catheter Cardiovasc Interv: 30 Sep 2020; 96:898-903

Percutaneous endovascular delivery of calcium chloride to the intact porcine carotid artery: A novel animal model of arterial calcification.

Abrão SR, Campos CM, Cavalcante R, Eggermont J, ... Abizaid A, de Brito FS
Objective
The present study evaluated the effect of endovascular administration of calcium chloride to the carotid artery of swines, to create a model of arterial calcification.
Methods
Fifteen Large White pigs were used for the study. Via endovascular treatment, carotid arteries were exposed during 9 min to either calcium chloride (experimental artery) or saline (control artery) with the use of the TAPAS catheter. Intravascular ultrasound (IVUS) imaging was obtained at baseline, postprocedure and at 30 days. Optical coherence tomography (OCT) imaging was obtained in vitro after carotids were harvested. Longitudinally cut parallel arterial segments were placed in a system of delicate clamps and underwent uniaxial strain test. All arteries underwent histopathological examination.
Results
Calcium chloride treated segments showed extensive circumferential parietal calcification evident on both IVUS and OCT. Reduction in minimal lumen area on IVUS was evident in experimental arteries both at 24 hr and 30 days postprocedure. Histopathologic assessment (Von Kossa stain) confirmed medial calcification with mild intimal thickening. Biomechanical testing showed treated segments to have smaller breaking strength and less elastic deformation than controls.
Conclusion
We developed a nonexpensive, reproducible model of early carotid medial calcification in pigs. Our model has the potential to help the development of research to unravel mechanisms underlying arterial calcification, the use of current or new devices to treat calcified lesions as well as to serve as an option for training interventionalists on the use of such devices.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Sep 2020; 96:E484-E492

Effects of intraaortic balloon counterpulsation on translesional coronary hemodynamics.

Seto AH, Yu J, Iwaz J, Kern MJ

The intraaortic balloon pump (IABP) provides counterpulsation by displacing a 40-50 cc blood volume during diastole augmenting diastolic pressure. The rapid deflation of the balloon timed to the initiation of systole reduces the afterload of ventricular ejection and thus peak systolic pressure. As a direct result, IABP increases mean arterial pressure (MAP) and peak diastolic pressure while reducing systolic pressure and myocardial work. IABP increases coronary flow velocity in non-obstructed vessels, but does not increase flow across a severe obstruction as shown by intracoronary Doppler flow studies (Kern et al., Circulation, 1993;87:500-511 and Kern et al., Circulation 1991;84:II-485). There are few studies using pressure sensor guidewires to confirm these responses. We present a case illustrating the translesional hemodynamics using an angioplasty sensor pressure wire across a severe stenosis and the unique influence of the IABP.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Sep 2020; 96:871-877

Prioritizing elective cardiovascular procedures during the COVID-19 pandemic: The cardiovascular medically necessary, time-sensitive procedure scorecard.

Waxman S, Garg A, Torre S, Wasty N, ... Cohen M, Salemi A
Background
Following the surge of the coronavirus disease 2019 (COVID-19) pandemic, government regulations, and recommendations from professional societies have conditioned the resumption of elective surgical and cardiovascular (CV) procedures on having strategies to prioritize cases because of concerns regarding the availability of sufficient resources and the risk of COVID-19 transmission.
Objectives
We evaluated the use of a scoring system for standardized triage of elective CV procedures.
Methods
We retrospectively reviewed records of patients scheduled for elective CV procedures that were prioritized ad hoc to be either performed or deferred when New Jersey state orders limited the performance of elective procedures due to the COVID-19 pandemic. Patients in both groups were scored using our proposed CV medically necessary, time-sensitive (MeNTS) procedure scorecard, designed to stratify procedures based on a composite measure of hospital resource utilization, risk of COVID-19 exposure, and time sensitivity.
Results
A total of 109 scheduled elective procedures were either deferred (n = 58) or performed (n = 51). The median and mean cumulative CV MeNTS scores for the group of performed cases were significantly lower than for the deferred group (26 (interquartile range (IQR) 22-31) vs. 33 (IQR 28-39), p < .001, and 26.4 (SE 0.34) vs. 32.9 (SE 0.35), p < .001, respectively).
Conclusions
The CV MeNTS procedure score was able to stratify elective cases that were either performed or deferred using an ad hoc strategy. Our findings suggest that the CV MeNTS procedure scorecard may be useful for the fair triage of elective CV cases during the time when available capacity may be limited due to the COVID-19 pandemic.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Oct 2020; 96:E602-E607

SAPIEN S3 valve deployment in the pulmonary position using the gore DrySeal sheath to protect the tricuspid valve.

Stapleton GE, Gowda ST, Bansal M, Khan A, Qureshi AM, Justino H
Background
Tricuspid valve injury can occur during implantation of a SAPIEN valve in the pulmonary position. We describe our experience using a long Gore DrySeal (GDS) sheath to protect the tricuspid valve during advancement of the Commander delivery system.
Methods
Retrospective single center review of all patients who underwent placement of a SAPIEN valve in the right ventricular outflow tract between January 2016 and April 2020. Patients were divided into two groups: delivery of the valve using standard technique (Group I), and with the use of a GDS (Group II), for comparison.
Results
There were 48 patients in total: 25 in Group I and 23 in Group II. In Group II, the first 10 patients had a 29 mm S3 placed through a 26 French (Fr), 65 cm GDS. We then performed additional crimping of the S3 onto the balloon after the balloon catheter was withdrawn to position the valve on the balloon outside the body. Subsequently, seven had a 29 mm S3 placed through a 24 Fr GDS, and four had a 26 mm S3 placed through a 22 Fr GDS including one weighing 16 kg. Two had a 23 mm S3 placed through a 22Fr GDS as the 20Fr GDS was not available in our lab. Severe tricuspid valve injury occurred in 2/25 (8%) of Group I patients and 0/23 of Group II patients.
Conclusion
Use of a long GDS may protect the tricuspid valve from injury during implantation of the S3 valve in the pulmonary position, and is technically feasible in smaller patients.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Oct 2020; 96:1287-1293

Direct transpedal pressure measurement during transpedal below-the-knee interventions in critical limb ischemia.

Ruzsa Z, Csavajda Á, Deák M, Viktor Ó, ... Merkely B, Kwan TW
Aim
The aim of this study was to assess the feasibility of the distal pressure measurement during transpedal below-the-knee interventions in chronic limb-threatening ischemia (CLTI) and to assess the hemodynamic response after percutaneous transluminal angioplasty.
Methods
The clinical and angiographic data of 137 consecutive patients treated via transpedal access in CLTI (Rutherford 4-6) were evaluated. Distal pedal pressure (PP) at the end of the pedal sheath was measured and the pedal-to-aortic pressure index (PAPI) was also calculated before and after the intervention.
Results
Good angiographic results was achieved in 131 patients (95.6%) in the femoro-popliteal and at least in one below-the-knee artery. Significant differences were found in PP and PAPI between before- and after-intervention values (103.2 ± 41.6 mmHg vs. 138.2 ± 37.8 mmHg and 0.74 ± 0.29 vs. 1.03 ± 0.34), respectively. Post-procedural PP and PAPI were significantly higher in patients who underwent good and borderline/unsuccessful intervention 141.7 [135.8-147.6] versus 82.6 [33.8-131.5] mmHg and 1.05 [1-1.1] versus 0.53 [0.2-0.8], respectively. PP\'s are significantly different in various Rutherford classification groups. Among the studied parameters, postprocedural PAPI was found to have the best discriminatory power to predict 3-month amputation (c-statistic: 0.749, 95% CI: 0.546-0.952, p = .016, sensitivity: 57.1%, specificity: 92.3% using the cut-off criterion ≤0.58). Major adverse event was detected in 17 patients at 3 months follow up (12.4%), including 7 major amputations (5.1%).
Conclusion
Transpedal pressure and pedal-to-aortic pressure index significantly increased during transpedal below-the-knee angioplasty and final pressure and index correlates significantly with limb salvage.

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

Catheter Cardiovasc Interv: 30 Sep 2020; 96:904-912

Comparative influence of bleeding and ischemic risk factors on diabetic patients undergoing percutaneous coronary intervention with everolimus-eluting stents.

Goel R, Cao D, Chandiramani R, Roumeliotis A, ... Valgimigli M, Mehran R
Objective
To investigate the impact of ischemic and bleeding risk factors on long-term clinical outcomes of patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) with everolimus-eluting stents.
Background
Second-generation drug-eluting stents have substantially improved outcomes after PCI in the general population; however, DM patients continue to experience high rates of ischemic and bleeding complications.
Methods
DM patients from the pooled XIENCE V registry were divided into high or low bleeding and ischemic risk groups (HBR, LBR, HIR, and LIR) based on established bleeding (age ≥ 75 years; chronic kidney disease; anemia; prior stroke; oral anticoagulation; thrombocytopenia; prior major bleeding) and ischemic (acute coronary syndrome; prior myocardial infarction [MI]; ≥3 stents implanted; ≥3 vessels treated; ≥3 lesions treated; stent length > 60 mm; bifurcation treated with ≥2 stents; chronic total occlusion) risk factors. The primary outcomes were major adverse cardiac events (MACE; cardiac death, MI, or stent thrombosis) and major bleeding at 4-year follow-up.
Results
A total of 3,704 DM patients were divided into four groups (21.5% LBR/LIR; 39.0% LBR/HIR; 15.6% HBR/LIR; 23.9% HBR/HIR). Compared with LBR/LIR patients, those at HBR/HIR and HBR/LIR had a significantly higher risk of MACE (HR (95% CI) 2.7 (1.9-3.9) and 2.2 (1.5-3.2), respectively) and major bleeding (2.7 (1.6-4.8) and 2.6 (1.4-4.7), respectively), while LBR/HIR patients did not.
Conclusions
Among DM patients undergoing PCI, presence of bleeding risk factors was associated with a higher risk of both ischemic and bleeding events, whereas commonly used features of ischemic risk did not impact long-term clinical outcomes.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 09 Oct 2020; epub ahead of print

SCAI shock classification in acute myocardial infarction: Insights from the National Cardiogenic Shock Initiative.

Hanson ID, Tagami T, Mando R, Kara Balla A, ... Basir MB,
Objectives
We applied the cardiovascular angiography and interventions (SCAI) shock staging system to patients presenting with acute myocardial infarction and cardiogenic shock (AMI-CS) who were enrolled in the National Cardiogenic Shock Initiative (NCSI).
Background
The SCAI shock staging system provides a framework for evaluation of patients with CS based on clinical and hemodynamic parameters, but has not been validated in patients with AMI-CS managed with a contemporary treatment algorithm that incorporates early use of Impella.
Methods
Consecutive patients enrolled in NCSI were identified, all of whom were managed with invasive hemodynamic guidance and supported with Impella. Patients were retrospectively categorized into appropriate SCAI shock stages, and outcomes were assessed accordingly.
Results
A total of 300 patients were included in the analysis; 182 patients (61%) presented in Stage C shock, 25 (8%) in Stage D, and 93 (31%) in Stage E. Survival to hospital discharge was 76, 76, and 58%, respectively (p = .006). Survival was <20% among patients in Stage E at 24 hr, regardless of baseline stage. There was near perfect agreement in shock staging between two independent clinicians at baseline (kappa = 0.975, 95% CI, 0.95-1.00, p < .001) and at 24 hr (kappa = 0.985, 95% CI, 0.77-1.00, p < .001).
Conclusion
In patients with AMI-CS enrolled in NCSI, SCAI Shock classification was reproducible, and predicted survival when applied at presentation and at 24 hr.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Oct 2020; 96:1137-1142

The reversed bell-bottom technique (ReBel-B) for the endovascular treatment of iliac artery aneurysms.

Mazzaccaro D, Righini P, Zuccon G, Modafferi A, Malacrida G, Nano G
Objective
To describe the results of the reversed bell-bottom (ReBel-B) technique for the endovascular treatment of iliac aneurysms (IA) involving the origin of hypogastric artery (HA).
Methods
The ReBel-B technique is a strategy for the occlusion of HA in selected patients presenting with IA, in whom the HA cannot be spared or safely occluded with coils or vascular plugs. When employing this technique, an iliac flared (\"bell-bottom\") extension is deployed in a reverse fashion, through a contralateral crossover femoral access that allows the occlusion of the HA at its origin, by exploiting the flared \"bell\" part of the reversed endograft. A second limb is then deployed to complete the implant, from the common iliac to the external iliac artery, inside the previous graft. Data of all consecutive patients treated with this technique in our experience were then retrospectively reviewed, and outcomes analyzed.
Results
The ReBel-B technique was employed in total of six patients who came in an emergent setting for the rupture of a common IA, from January 2014 to December 2018. Endovascular exclusion was performed using a ReBel-B graft plus iliac leg in five out of six cases. In the remaining case, a bifurcated aortic endograft was used to complete the aneurysm exclusion. Technical success was 100%. No complications occurred.
Conclusions
In selected cases, the ReBel-B technique can be used for the complete exclusion of IA preventing type II endoleak from the HA, when the embolization with coils or plug or the preservation of the HA is anatomically unfeasible.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Sep 2020; 96:E479-E483

Clinical and procedural characteristics of COVID-19 patients treated with percutaneous coronary interventions.

Siudak Z, Grygier M, Wojakowski W, Malinowski KP, ... Dudek D, Bartuś S
Background
COVID-19 pandemic has affected healthcare systems worldwide. Resources are being shifted and potentially jeopardize safety of non-COVID-19 patients with comorbidities. Our aim was to investigate the impact of national lockdown and SARS-CoV-2 pandemic on percutaneous treatment of coronary artery disease in Poland.
Methods
Data on patients who underwent percutaneous coronary procedures (angiography and/or percutaneous coronary intervention [PCI]) were extracted for March 13-May 13, 2020 from a national PCI database (ORPKI Registry) during the first month of national lockdown and compared with analogous time period in 2019.
Results
Of 163 cardiac catheterization centers in Poland, 15 (9.2%) were indefinitely or temporarily closed down due to SARS-CoV-2 pandemic. There were nine physicians (9 of 544; 1.7%) who were infected with SARS-CoV-2. There were 13,750 interventional cardiology procedures performed in Poland in the analyzed time period. In 66% of cases an acute coronary syndrome was diagnosed, and in the remaining 34% it was an elective procedure for the chronic coronary syndrome in comparison to 50% in 2019 (p < .001). There were 362 patients (2.6% of all) with COVID-19 confirmed/suspected who were treated in interventional cardiology centers and 145 with ST-Elevation Myocardial Infarction (STEMI) diagnosis (6% of all STEMIs).
Conclusions
Due to SARS-CoV-2 pandemic there was an absolute reduction in the number of interventional procedures both acute and elective in comparison to 2019 and a significant shift into acute procedures. COVID-19 confirmed/suspected patients do not differ in terms of procedural and baseline characteristics and reveal similar outcomes when treated with percutaneous coronary interventions.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Oct 2020; 96:E568-E575

Mortality in patients undergoing revascularization with paclitaxel eluting devices for infrainguinal peripheral artery disease: Insights from a network meta-analysis of randomized trials.

Kuno T, Ueyama H, Mikami T, Takagi H, ... Anzai H, Bangalore S
Objectives
We aimed to evaluate whether paclitaxel eluting devices increased the risk of death in patients undergoing revascularization for infrainguinal peripheral artery disease using network meta-analyses.
Methods
PUBMED and EMBASE were searched through April 2020 for randomized trials in patients with infrainguinal peripheral artery disease who underwent revascularization with or without a paclitaxel eluting device (balloon/stent). Short-term mortality defined as death at 6-12 months, and long-term mortality defined as death at >12 months after revascularization.
Results
Our search identified 57 eligible randomized controlled studies enrolling a total of 9,362 patients comparing seven revascularization strategies (balloon angioplasty vs. bare metal stent vs. covered stent vs. paclitaxel eluting stent vs. other drug eluting stent vs. paclitaxel-coated balloon vs. bypass surgery). Overall, paclitaxel eluting stent and paclitaxel-coated balloons did not increase short-term mortality (eg, vs. balloon angioplasty: paclitaxel-coated balloon OR [95% CI] 1.21 [0.88-1.66], p = .24; paclitaxel eluting stent OR [95%CI] 1.01 [0.63-1.63], p = .97, respectively). In addition, paclitaxel eluting stent did not show significant increase in long-term mortality (eg, vs. balloon angioplasty: OR [95%CI] 1.06 [0.70-1.59], p = .79). However, paclitaxel-coated balloon showed significant increase in long-term mortality compared to balloon angioplasty and bypass (vs. balloon angioplasty: OR [95% CI] 1.48 [1.06-2.07], p = .021; vs. bypass: OR [95%CI] 1.73 [1.05-2.84], p = .031, respectively).
Conclusions
In this meta-analysis of randomized trials, there was no significant increase in mortality with paclitaxel eluting stent, but there was increased risk of long-term mortality in paclitaxel-coated balloon for the treatment of infrainguinal peripheral artery disease.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Sep 2020; 96:E467-E478

Outcomes of percutaneous coronary interventions in patients with liver transplant.

Shah H, Ramineni G, Varghese R, Thwe EE, ... Gandhi D, Solanki S
Objective
Our aim is to describe characteristics of liver transplant patients undergoing percutaneous coronary interventions (PCI) as well as in-hospital outcomes including the mortality and peri-procedural complications from the largest publicly available inpatient database in the United States from 2002 to 2014.
Background
Outcomes of PCI are well studied in patients with end-stage liver disease but not well studied in patients who receive liver transplant (LT).
Methods
Data derived from Nationwide Inpatient Sample (NIS) were analyzed for years 2002-2014. Adult Hospitalizations with PCI were identified using ICD-9-CM procedure codes. LT status and various complications were identified by using previously validated ICD-9-CM diagnosis codes. Endpoints were in-hospital mortality and peri-procedural complications. Propensity match analysis was performed to compare the endpoints between two groups.
Results
During the study period, 8,595,836 patients underwent PCI; 4,080 (0.04%) patients had prior LT status. 93% of patients were above age 59 years, 79% were males and 69% were nonwhites. Out of the total patients with LT status, 73% had hypertension, 57% had diabetes mellitus, and 47% had renal failure. Post-PCI complications were studied further in both liver and non-LT patients after 1:1 propensity match which showed the incidence of acute kidney injury (AKI) was higher in LT group (12.3 vs 10.7%, p = .024) but dialysis requiring AKI was similar.
Conclusion
Among the LT recipients undergoing PCI, majority were nonwhite males. Almost more than half of the recipients had diabetes mellitus and renal failure. Incidence of AKI was higher in LT group, but other peri-procedural complications were comparable.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Oct 2020; 96:E576-E584

Codeployment of a percutaneous edge-to-edge mitral valve repair device and a ventriculoseptal defect occluder device to address complex mitral regurgitation with leaflet perforation.

Addis DR, Law M, von Mering G, Ahmed M

An 80-year-old male with severe, complex mitral regurgitation (MR) after recent transcatheter aortic valve replacement presented in heart failure for percutaneous mitral valve repair and possible tricuspid valve repair. Transesopheageal echocardiography (TEE) demonstrated mixed Carpentier Types 1 and 2 components with annular dilation, two leaflet perforations, and excessive leaflet motion (P2 flail). There were three distinct MR jets appreciated reflecting a central coaptation defect and two posterior mitral valve leaflet perforations emanating from a cystic dilatation. Under TEE guidance transseptal puncture and percutaneous edge-to-edge mitral valve repair was performed with a MitraClip XTR device (Abbott, IL). A 10 mm Amplatzer Muscular VSD Occluder (Abbott, Abbott Park, IL) was deployed to close one of the perforations on the posterior leaflet with a significant reduction in MR severity. Attempts at crossing the remaining defect were unsuccessful and the procedure was concluded. The patient recovered uneventfully and transthoracic echocardiography on postoperative day (POD) 1 and again on POD 34 demonstrated normal systolic dominance on pulmonary venous Doppler interrogation, mild to moderate MR, and a mean transvalvular gradient of 5 mmHg. Both devices appeared firmly attached and stable. This is the first documented use of a VSD occluder device in this clinical scenario. Management of complex MR with an approach combining edge-to-edge repair for a central coaptation defect and leaflet flail with codeployment of a VSD occluder device to address a perforated leaflet is feasible and can achieve durable results.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Oct 2020; 96:1333-1338

The \"lend a hand\" external bypass technique: External radial to femoral bypass for antegrade perfusion of an ischemic limb with occlusive large bore sheath - A novel and favorable approach.

Lichaa H

An occlusive large bore sheath is a frequently encountered situation in cases of cardiogenic shock (CS) requiring mechanical circulatory support (MCS). Resultant acute limb ischemia could be a catastrophic complication which significantly affects the prognosis of an already sick patient population. A novel, yet simple, technique using the radial artery, instead of the ipsilateral or contralateral common femoral artery (CFA), as a donor vessel of an external bypass which provides antegrade perfusion to a limb with an occlusive large bore sheath is hereby described. Radial access (RA) has been shown to improve mortality in acute coronary syndrome; however, it is sometimes avoided by some operators in CS cases due to the possible appropriate need for MCS. This technique offers a substitution of a second CFA access for a RA in order to provide adequate ipsilateral limb perfusion. Hence, one can start a CS case with a default RA and perform peripheral angiography after diagnostic cardiac catheterization. If the peripheral vasculature is inappropriate for MCS, the patient would have already benefited from the mortality advantage of RA. If obstructive PAD is absent, then an occlusive Impella sheath can be placed in a CFA after antegrade ipsilateral superficial femoral artery (SFA) access is obtained for an external radial to femoral bypass, while the PCI is performed through the Impella sheath according to the single access PCI technique. Finally, the advantages and disadvantages of this new approach are described and compared with each of the traditionally known external and internal femoral bypass techniques.

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

Catheter Cardiovasc Interv: 30 Oct 2020; 96:E614-E620

Outcomes following endovascular therapy for acute stroke by interventional cardiologists.

Bob-Manuel T, Hornung M, Guidera S, Prince M, ... Grunwald I, White CJ
Objectives
To summarize the outcomes of acute ischemic stroke (AIS) intervention by interventional cardiologists (IC) working on a stroke team.
Background
There is a geographic maldistribution of dedicated neuro-interventionalists (NI) to treat large vessel occlusion (LVO) AIS.
Methods
Results of 166 consecutive patients who received endovascular therapy (EVT) for AIS due to LVO by IC at three centers between 2009 and 2019 are reported. A modified Rankin score (mRs) of ≤ 2 at 90 days after EVT was used as the primary measurement of a good neurological outcome. Univariate logistic regression was used to evaluate predictors of the mRS > 2 and mortality. Those variables with significance of p < .2 from the univariate analysis were included in a multivariate analysis.
Results
All-cause mortality at 30 days was 22%. A favorable clinical outcome, mRS ≤ 2 at 90 days, was 49%. After multivariate analysis and controlling for confounders, a higher baseline NIHSS was predictive of 30-day mortality (OR 1.20 [95% CI 1.09-1.32] p < .001) and unfavorable clinical outcome (mRS > 2) at 90 days (OR 1.16 [95% CI 1.07-1.25] p < .001).
Conclusion
Outcomes for carotid stent capable IC performing EVT for AIS are comparable to those achieved by NI physicians in major randomized clinical trials. Our data supports conducting a clinical trial of carotid stent capable IC working on multidisciplinary stroke teams to perform EVT for AIS due to LVO in communities and hospitals without timely access (<60 min by ground transport) to dedicated NI.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Oct 2020; 96:1296-1303

Clinical characteristics and in hospital outcomes of heart transplant recipients undergoing percutaneous coronary intervention: Insights from the National Inpatient Sample.

Shah H, Patel S, Solanki S, Wudexi I, ... Shah C, Patel A
Objectives
Cardiac transplant patients are at increased risk of Coronary Allograft Vasculopathy which requires percutaneous coronary intervention (PCI).
Background
We aim to determine national epidemiology describing trends, mortality, and morbidity risks in patients with heart transplant undergoing PCI.
Methods
We used Nationwide Inpatient Sample (NIS) data from 2002 to 2014 to identify adult hospitalizations with PCI using ICD 9 codes. Acute myocardial infarction (AMI), cardiac transplant status and complications were identified using validated ICD-9-CM diagnosis codes. Endpoints were in-hospital mortality and peri-procedural complications. Propensity match analysis was performed to compare the end-points between DES and BMS.
Results
Total 8,613,900 patients underwent PCI, of which 1,531(0.002%) patients had prior heart transplant status. Among these 1,531 PCIs, 311(20%) were due to AMI including 125(8%) due to STEMI. 74% of PCIs were done in males and 78% of the PCIs were performed in the 60-79 age group. Out of 1,380 stents placed, 1,090 were DES (79%) and 290 (21%) were BMS. Mortality was higher in the BMS versus DES (8.34% vs. 3.45%, p = .012), Conclusion: We concluded that majority of the population who underwent PCI were older males. DES was used more than BMS. The use of BMS is associated with increased mortality, cardiac complications and Acute Kidney Injury requiring dialysis compared with DES which likely is representative of preferential use of DES in these patient population.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Oct 2020; 96:E585-E592

Prospective validation of the SCAI shock classification: Single center analysis.

Baran DA, Long A, Badiye AP, Stelling K
Background
The Society for Cardiac Angiography and Interventions (SCAI) Shock Classification has been retrospectively validated by several groups. We sought to prospectively study outcomes of consecutive patients with reference to initial SCAI Shock Stage and therapeutic strategy as well as 24 hr SCAI Shock Stage reassessment.
Methods
Kaplan Meier method was used to describe survival and Cox Proportional hazards modeling used to assess predictors of survival.
Results
Over an 18-month period, 166 patients were referred for evaluation. Demographics, hemodynamics, and most laboratory findings were similar between SCAI stages, which were assigned by the team. Initial SCAI Stage was a strong predictor of survival. Thirty-day survival was 100, 65.4, 44.2, and 60% for patients with initial SCAI shock stage B, C, D, and E respectively (p = .0004). Age and initial SCAI Shock Stage were shown to be the strongest predictors of survival by Cox proportional hazards. Mode of mechanical circulatory support (MCS) or lack of such was not a predictor of outcome. Shock stage at 24 hr was also examined. Thirty-day survival was 100, 96.7, 66.9, 21.6, and 6.2% for patients with 3-4 SCAI stage improvement, 2 stage improvement, 1 stage improvement, no change in SCAI stage and worsening of SCAI stage respectively (p < .0001).
Conclusions
Initial SCAI Shock stage predicts the survival of unselected patients with a variety of MCS interventions and medical therapy alone. The 24-hr reassessment of shock stage further refines the prognosis.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 06 Oct 2020; epub ahead of print

Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions 2020 think tank.

Naidu SS, Coylewright M, Hawkins BM, Meraj P, ... White S, Williams DM

The society for cardiovascular angiography and interventions (SCAI) think tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community for high-level field-wide discussions. The 2020 think tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease (CHD). Each session was moderated by a senior content expert and co-moderated by a member of SCAI\'s emerging leader mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialogue from a broader base, and thereby aid SCAI and the industry community in developing specific action items to move these areas forward.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Oct 2020; 96:1258-1265

Trends of repeat revascularization choice in patients with prior coronary artery bypass surgery.

Mohamed MO, Shoaib A, Gogas B, Patel T, ... Bagur R, Mamas MA
Objective
To examine rates and predictors repeat revascularization strategies (percutaneous coronary intervention [PCI] and coronary artery bypass grafting [CABG]) in patients with prior CABG.
Methods
Using the National Inpatient Sample, patients with a history of CABG hospitalized for revascularization by PCI or CABG from January 2004 to September 2015 were included. Regression analyses were performed to examine predictors of receipt of either revascularization strategy as well as in-hospital outcomes.
Results
The rate of redo CABG doubled between 2004 (5.3%) and 2015 (10.3%). Patients who underwent redo CABG were more comorbid and experienced significantly worse major adverse cardiovascular and cerebrovascular events (odds ratio [OR]: 5.36 95% CI 5.11-5.61), mortality (OR 2.84 95% CI 2.60,-3.11), bleeding (OR 5.97 95% CI 5.44-6.55) and stroke (OR 2.15 95% CI 1.92-2.41), but there was no difference in cardiac complications between groups. Thoracic complications were high in patients undergoing redo CABG (8%), especially in females. Factors favoring receipt of redo CABG compared to PCI included male sex, age < 80 years, and absence of diabetes and renal failure.
Conclusion
Reoperation in patients with prior CABG has doubled in the United States over a 12-year period. Patients undergoing redo CABG are more complex and associated with worse clinical outcomes than those receiving PCI.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 04 Sep 2020; epub ahead of print

Comparison of the Sapien 3 versus the ACURATE neo valve system: A propensity score analysis.

Kooistra NH, Intan-Goey VMP, Ziviello F, Leenders GE, ... Voskuil M, Stella PR
Objectives
To compare the outcomes of transfemoral ACURATE neo (NEO) and Sapien 3 (S3) patients in terms of device success and clinical safety outcomes using a propensity score analysis.
Background
Differences in clinical outcomes between the latest-generation balloon-expandable S3 and self-expanding NEO in a \"real-world transfemoral TAVI population\" are still unclear.
Methods
We compared up to 6 months clinical outcomes using a propensity score analysis (inverse probability of treatment weighting [IPTW]) to account for differences in baseline characteristics.
Results
A total of 345 patients underwent transfemoral transcatheter aortic valve implantation (TAVI) with either NEO or S3 at two centers in the Netherlands. Composite device success and early safety endpoints were comparable between NEO and S3 (Device success: IPTW-adjusted OR: 0.35 [95% CI: 0.12-1.18], and early safety: IPTW-adjusted OR: 0.51 [95% CI: 0.19-1.38]). Six-months mortality was 5.3 versus 3.6%, stroke was 2.8 versus 3.3%, and pacemaker rate was 6.1 versus 8.6%, respectively with p = NS. Mean aortic gradient was lower in the NEO group (5.72 ± 2.47 vs. 9.05 ± 3.48; p = <.001), with a comparable rate of moderate or severe paravalvular leak (0 versus 2.1%; p = NS).
Conclusions
Device success and clinical safety outcomes were comparable for both valves. Up to 6-months follow-up clinical outcomes and mortality rate remained excellent. Mean aortic gradient was lower after ACURATE neo implantation.

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

Catheter Cardiovasc Interv: 03 Sep 2020; epub ahead of print

Four-year mortality in women and men after transfemoral transcatheter aortic valve implantation using the SAPIEN 3.

Tarantini G, Baumgartner H, Frank D, Husser O, ... Hovorka T, Wendler O
Objectives
To investigate 4-year, post-transcatheter aortic valve implantation (TAVI) survival and predictors of survival by sex, in a real-world cohort that underwent transfemoral TAVI with SAPIEN 3 transcatheter heart valve.
Background
Previous TAVI investigations of first-generation devices demonstrated an early- to mid-term survival advantage in women compared with men.
Methods
SOURCE 3 (SAPIEN 3 Aortic Bioprosthesis European Outcome) is a post-approval, multicentre, observational registry. Patients (N = 1,694, 49.2% women, age 81.7 ± 6.7 years) with severe aortic stenosis and high surgical risk (logistic EuroSCORE 17.8%) underwent TAVI between 2014 and 2015. Kaplan-Meier event estimates were used to determine mortality by sex. Predictors of overall mortality were identified using a cox multivariate proportional hazard model.
Results
At 4 years, women had lower all-cause mortality than men (36.0 vs 39.7%; p = .0911; HR: 0.87 [95% CI: 0.75-1.02]). No difference was observed for cardiac mortality between women 24.2% and men 24.7% (p = .76; HR: 0.97 [95% CI: 0.79-1.19]). When adjusted for baseline characteristics (age, height, weight, NYHA functional class, renal insufficiency, EuroScore, and tricuspid regurgitation), sex had no impact on mortality.
Conclusions
In this large, real-world cohort, all-cause mortality trended lower in women than men at 4 years post TAVI; however, several baseline factors, but not sex, were predictors of mortality. No difference between sexes was observed for cardiovascular mortality.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 03 Sep 2020; epub ahead of print

Carotid access for transcatheter aortic valve replacement: A meta-analysis.

Sharma SP, Chaudhary R, Ghuneim A, Harder W, ... Kambhatla S, Kondur A
Objective
We sought to evaluate the feasibility and safety of carotid access transcatheter aortic valve replacement (TAVR) by performing a meta-analysis of published cases.
Background
Several case series and regional data have provided initial basis for carotid access TAVR in patients with prohibitive femoral approach. We performed this meta-analysis to provide further evidence of feasibility and safety of carotid TAVR.
Methods
We searched PubMed, EMBASE, CINAHL, and Cochrane CENTRAL for any study on carotid access TAVR involving ⩾5 patients since inception till March 1, 2020. Random-effects model was used to compute overall effects. The outcomes analyzed were all-cause mortality, Transient ischemic attack (TIA)/stroke, need for permanent pacemaker (PPM) implantation, pericardial tamponade, access site complications, major bleeding, and length of stay.
Results
There was a total of 17 retrospective studies (n = 2082) with a median follow-up of 1 month. Mean age of the patient was 80 years. Mean Euroscore and STS scores were 15 ± 6.2 and 7.9 ± 3.3, respectively. The procedural success rate was 99%. The rate of all-cause mortality was 6.7% (range 4.6-9.7%, p < .001, I = 67%). Incidence of TIA/stroke was 3.9% (range 3.1-4.8%, p < .001, I = 0%) and PPM implantation was 16.7% (range 12.5-21.9%, p < .001, I = 56%). Rate of pericardial tamponade, vascular complication, and major bleeding were 1.7, 2.5, and 7%, respectively. Average length of hospital stay was 7.7 days.
Conclusion
Our results show that transcarotid approach is a feasible option in patients with prohibitive femoral access for TAVR.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 04 Sep 2020; epub ahead of print

Individual patient data analysis of the BIOFLOW study program comparing safety and efficacy of a bioresorbable polymer sirolimus eluting stent to a durable polymer everolimus eluting stent.

Toelg R, Slagboom T, Waltenberger J, Lefèvre T, ... Koolen J, Richardt G
Objectives
This analysis of pooled individual patient data (IPD) aimed to evaluate the safety and efficacy of a bioresorbable polymer sirolimus eluting stent system (BP-SES; Orsiro) compared to a durable polymer everolimus eluting stent system (DP-EES; Xience) in the pooled population as well as in subgroups.
Methods
IPD with up to 12 months follow-up of the randomized controlled trials BIOFLOW-II (NCT01356888), -IV (NCT01939249), and -V (NCT02389946) as well as the all comers registry BIOFLOW-III (NCT01553526) were pooled. A total of 3,717 subjects (2,923 in BP-SES and 794 in DP-EES) with 5,328 lesions (4,225 lesions in BP-SES and 1,103 in DP-EES) were included in the IPD. The primary endpoint was target lesion failure (TLF) at 12 months follow-up. Subgroups analyzed included diabetes, age (≥65 years), gender, complex lesions (B2/C), small vessels (reference vessel diameter ≤2.75 mm), multivessel treatment, renal disease, and patients with acute coronary syndrome.
Results
Overall, TLF at 12 months was significantly lower with 5.2%in the BP-SES group versus 7.6% in the DP-EES group (p = .0098). Similarly, target vessel myocardial infarction (TV-MI) was 3.1 versus 5.7% (p = .0005). The rate of stent thrombosis was similar in both groups (0.004%). By regression analysis, an independent stent effect in favor of BP-SES was observed for TLF (p = .0043) and TV-MI (p = .0364) in small vessels.
Conclusion
Results of this IPD analysis suggest that the BP-SES with ultrathin struts is as safe as and more efficacious than DP-EES in the overall cohort and especially in small vessels.

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

Catheter Cardiovasc Interv: 04 Sep 2020; epub ahead of print

Intravascular lithotripsy in saphenous vein grafts and graft stent failure: A case series.

Øksnes A, McEntegart M

The long-term patency of saphenous vein grafts (SVGs) is poor compared to arterial bypass grafts. Re-do coronary artery bypass graft surgery (CABG) is high risk, thus graft failure often requires revascularization with percutaneous coronary intervention (PCI). While PCI to the native vessels is preferable, PCI to SVGs is sometimes necessary despite being associated with a high incidence of stent failure. While early SVG degeneration is associated with friable disease, calcification becomes an increasing problem in older grafts. Intravascular Lithotripsy (IVL) has been demonstrated to be safe and effective in the treatment of calcified native coronary artery disease (CAD). We present the first case series of five patients undergoing PCI to de novo SVG disease or SVG stent failure utilizing IVL for calcium modification.

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

Catheter Cardiovasc Interv: 08 Sep 2020; epub ahead of print

Functional coronary angiography in symptomatic patients with no obstructive coronary artery disease.

Kumar S, Mehta PK, Eshtehardi P, Hung OY, ... Quyyumi A, Samady H
Background
Patients without obstructive coronary artery disease (CAD) may have epicardial or microvascular dysfunction. The purpose of this study was to characterize patterns of epicardial and microvascular dysfunction in men and women with stable and unstable angina undergoing functional coronary angiography to inform medical therapy.
Methods
163 symptomatic patients with ≤50% diameter stenosis and fractional flow reserve (FFR) > 0.8 underwent endothelium-dependent epicardial and microvascular function after intracoronary acetylcholine (10 M, 81 mcg over 3 minutes). Endothelium-independent function was assessed using coronary flow reserve (CFR) and hyperemic microvascular resistance (HMR) after intravenous adenosine (140 ug/kg/min). Coronary microvascular dysfunction (CMD) was defined as CFR < 2.5, HMR ≥2, or ≤50% change in coronary blood flow with acetylcholine (CBF ).
Results
Seventy-two percent had endothelial-dependent epicardial dysfunction (response to ACH: % ∆ in coronary artery diameter and ∆%CBF ) and 92% had CMD. Among CMD patients, 65% had CFR < 2.5, 35% had HMR ≥2, and 60% had CBF change ≤50%. CFR modestly correlated with HMR (r = -0.38, p < .0001). Among patients with normal CFR, 26% had abnormal epicardial and 20% had abnormal microvascular endothelial dysfunction. Women had a lower CFR (p = .02), higher FFR (p = .03) compared to men. There were no differences in epicardial and microvascular function between patients with stable and unstable angina.
Conclusion
In patients with no obstructive CAD: CMD is prevalent, abnormal CFR does not correlate with epicardial or microvascular endothelial dysfunction, women have lower CFR, higher FFR but similar endothelial function compared to men.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Sep 2020; epub ahead of print

Acute and medium term results of balloon expandable stent placement in the transverse arch-a multicenter pediatric interventional cardiology early career society study.

Shahanavaz S, Aldoss O, Carr K, Gordon B, ... Zablah J, Morgan G
Objectives and background
Coarctation of the aorta represents 5-8% of all congenital heart disease. Although balloon expandable stents provide an established treatment option for native or recurrent coarctation, outcomes from transverse arch (TAO) stenting, including resolution of hypertension have not been well studied. This study aims to evaluate immediate and midterm results of TAO stenting in a multi-center retrospective cohort.
Methods
TAO stenting was defined as stent placement traversing any head and neck vessel, with the primary intention of treating narrowing in the transverse aorta. Procedural details, complications and medications were assessed immediately post procedure, at 6 month follow-up and at most recent follow-up.
Results
Fifty-seven subjects, 12 (21%) native, and 45 (79%) surgically repaired aortic arches, from seven centers were included. Median age was 14 years (4 days-42 years), median weight 54 kg (1.1-141 kg). After intervention, the median directly measured arch gradient decreased from 20 mmHg (0-57 mmHg) to 0 mmHg (0-23 mmHg) (p < .001). The narrowest arch diameter increased from 9 mm (1.4-16 mm) to 14 mm (2.9-25 mm) (p < .001), with a median increase of 4.9 mm (1.1-10.1 mm). One or more arch branches were covered by the stent in 55 patients (96%). There were no serious adverse events. Two patients warranted stent repositioning following migration during deployment. There were no late complications. There were 8 reinterventions, 7 planned, and 1 unplanned (6 catheterizations, 2 surgeries). Antihypertensive management was continued in 19 (40%) at a median follow-up of 3.2 years (0.4-7.3 years).
Conclusions
TAO stenting can be useful in selected patients for resolution of stenosis with minimal complications. This subset of patients are likely to continue on antihypertensive medications despite resolution of stenosis.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Oct 2020; 96:1277-1286

Seasonal variation in U.S. hospitalizations for chronic limb-threatening ischemia.

Altin SE, Kim YG, Aronow HD, Armstrong EJ, ... Mena-Hurtado CI, Abbott JD
Background
Seasonal variation in coronary artery disease is well described, with a peak in the winter and a trough in the summer. However, little is known about seasonal trends in hospital admission for critical limb-threatening ischemia (CLTI) and associated outcomes.
Methods
Patients admitted with CLTI from January 1, 2012 through August 31, 2015 were identified in the Healthcare Cost and Utilization Project\'s National Inpatient Sample based upon administrative claims diagnosis codes. The primary outcome was seasonal hospitalization incidence, and secondary outcomes included mortality rates and rates of in-hospital major and minor amputations among nondiabetics and diabetics.
Results
Of 1,276,745 hospitalizations for CLTI during the study period, 28.3% occurred in the spring, the peak admission season, and 19.1% occurred in the fall, the nadir. In-hospital mortality was highest during the winter (adjusted odds ratio [OR]: 1.08; 95% confidence interval [CI]: 1.03-1.14), and followed the highest seasonal rates of influenza in the fall; however, other important comorbidities did not differ significantly by season. For the overall cohort, there was no significant seasonal variation in rates of major or minor amputation, although seasonal rates were different according to diabetic status. Patients without diabetes had the highest odds of amputation in the spring (OR 1.07; 95% CI: 1.02-1.12), although this trend was not identified among patients with diabetes.
Conclusions
There is significant seasonal variability in CLTI admissions and mortality but minimal variability in amputation rates. Understanding the seasonal variation in CLTI may help to identify individuals at greatest risk for hospitalization and death through patient and provider education efforts.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Sep 2020; epub ahead of print

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: 08 Sep 2020; epub ahead of print

Usefulness of oral anticoagulation in patients with coronary aneurysms: Insights from the CAAR registry.

D\'Ascenzo F, Saglietto A, Ramakrishna H, Andreis A, ... Núñez-Gil IJ,
Objectives
To assess the Usefulness of oral anticoagulation therapy (OAT) in patients with coronary artery aneurysm (CAA).
Background
Data on the most adequate antithrombotic CAA management is lacking.
Methods
Patients included in CAAR (Coronary Artery Aneurysm Registry, Clinical Trials.gov: NCT02563626) were selected. Patients were divided in OAT and non-OAT groups, according to anticoagulation status at discharge and 2:1 propensity score matching with replacement was performed. The primary endpoint of the analysis was a composite and mutual exclusive endpoint of myocardial infarction, unstable angina (UA), and aneurysm thrombosis (coronary ischemic endpoint). Net adverse clinical events, major adverse cardiovascular events, their single components, cardiovascular death, re-hospitalizations for heart failure, stroke, aneurysm thrombosis, and bleeding were the secondary ones.
Results
One thousand three hundred thirty-one patients were discharged without OAT and 211 with OAT. In the propensity-matched sample (390 patients in the non-OAT group, 195 patients in the OAT group), after 3 years of median follow-up (interquartile range 1-6 years), the rate of the primary endpoint (coronary ischemic endpoint) was significantly less in the OAT group as compared to non-OAT group (8.7 vs. 17.2%, respectively; p = .01), driven by a significant reduction in UA (4.6 vs. 10%, p < .01) and aneurysm thrombosis (0 vs. 3.1%, p = .03), along with a non-significant reduction in MI (4.1 vs. 7.7%, p = .13). A non-significant increase in bleedings, mainly BARC type 1 (55%), was found in the OAT-group (10.3% in the non-OAT vs. 6.2% in the OAT group, p = .08).
Conclusion
OAT decreases the composite endpoint of UA, myocardial infarction, and aneurysm thrombosis in patients with CAA, despite a non-significant higher risk of bleeding.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Sep 2020; epub ahead of print

Comparison of simple versus complex stenting in patients with true distal left main bifurcation lesions.

Lee CH, Ahn JM, Kang DY, Han M, ... Park DW, Park SJ
Introduction
Distal left main (LM) bifurcation disease is one of the most challenging lesion subsets for percutaneous coronary intervention (PCI) and optimal stenting strategy for such complex lesions is still debated. This study aimed to compare clinical outcomes following single versus dual stenting for true distal LM bifurcation lesions.
Methods
Patients with true distal LM bifurcation lesions (type 1,1,1 or 0,1,1: both left anterior descending and circumflex artery >2.5 mm diameter) receiving PCI with drug-eluting stents (DES) from two large clinical registries were evaluated. The primary outcome was target-lesion failure (TLF), defined as a composite of cardiac death, target-vessel myocardial infarction (MI), or target-lesion revascularization (TLR). Outcomes were compared with the use of propensity scores and inverse probability-weighting adjustment to reduce treatment selection bias.
Results
Among 1,002 patients undergoing true distal LM PCI, 440 (43.9%) and 562 (56.1%) were treated with single and dual stents, respectively. The TLF rates at 3 year was 20.3% in the single-stent group and 24.1% in the dual-stenting group (log-rank p = 0.18). The adjusted risk for TLF did not differ significantly between two groups (hazard ratio [HR] with dual-stent vs. single-stent: 1.27, 95% confidence interval [CI]: 0.95-1.71). The adjusted risks for death, MI, repeat revascularization, or stent thrombosis were also similar between the single- and dual-stenting groups.
Conclusions
In patients undergoing PCI for true distal LM disease, single- and dual-stent strategies showed a similar adjusted risk of TLF at 3 years. Our findings should be confirmed or refuted through large, randomized clinical trials.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 07 Sep 2020; epub ahead of print

Distribution of C-arm projections in native and bioprosthetic aortic valves cusps: Implication for BASILICA procedures.

Komatsu I, Tang GHL, Leipsic J, Webb JG, ... Abdel-Wahab M, Dvir D
Objectives
We sought to document aortic cusps fluoroscopic projections and their distributions using leaflet alignment which is a novel concept to optimize visualization of leaflets and for guiding BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent coronary artery obstruction) and determine whether these projections were feasible in catheter laboratory.
Background
Optimal fluoroscopic projections of aortic valve cusps have not been well described.
Methods
A total of 128 pre-transcatheter aortic valve replacement (pre-TAVR) computed tomographies (CT) (72 native valves and 56 bioprosthetic surgical valves) were analyzed. Using CT software (3Mensio, Pie medical imaging, the Netherlands), leaflet alignment was performed and the feasibility of these angles, which were defined as rate of obtainable with efforts (within LAO/RAO of 85° and CRA/CAU of 50°) were evaluated.
Results
High feasibility was seen in right coronary cusp (RCC) front view (100%) and left coronary cusp (LCC) side view (99.2%), followed by noncoronary cusp side view (95.3%). In contrast, low feasibility of RCC side view (7.8%) and LCC front view (47.6%) was observed. No statistical differences were seen between the distribution of native valves and bioprosthetic surgical valves. With patient/table tilt of 20°LAO and 10°CRA, the feasibility of RCC side view and LCC front view increased to 43.7 and 85.2%, respectively.
Conclusion
Distributions of each cusp\'s leaflet alignment follows \"sigmoid curve\" which can provide better understanding of aortic valve cusp orientation in TAVR and BASILICA. RCC side view used in right cusp BASILICA is commonly unachievable in catheter laboratory and may improve with patient/table tilt.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 06 Sep 2020; epub ahead of print

Safety and efficacy of mechanical circulatory support with Impella or intra-aortic balloon pump for high-risk percutaneous coronary intervention and/or cardiogenic shock: Insights from a network meta-analysis of randomized trials.

Kuno T, Takagi H, Ando T, Kodaira M, ... Fox J, Bangalore S
Background
Mechanical circulatory support (MCS) with Impella or intra-aortic balloon pump (IABP) is used for high-risk percutaneous coronary intervention (PCI) and/or for cardiogenic shock (CS) due to acute myocardial infarction. We aimed to investigate the efficacy and safety of Impella or IABP when compared with no MCS using a network meta-analysis of randomized controlled trials (RCTs).
Methods
EMBASE and MEDLINE were searched through February 2020 for RCT evaluating efficacy of Impella vs. IABP vs. no MCS in patients undergoing high-risk PCI or CS. The primary efficacy outcome was 30 day or in-hospital all-cause mortality whereas the primary safety outcomes were major bleeding and vascular complications.
Results
Our search identified nine RCTs enrolling a total of 1,996 patients with high-risk PCI and/or CS. There was no significant difference with Impella or IABP on all-cause mortality when compared with no MCS (Impella vs. no MCS; OR:0.82 [0.35-1.90], p = .65, IABP vs. no MCS; OR:0.77 [0.47-1.28], p = .31, I = 18.1%). Impella significantly increased major bleeding compared with no MCS (Impella vs. no MCS; OR:7.01 [1.11-44.4], p = .038, I = 19.2%). IABP did not increase the risk of major bleeding compared with no MCS (OR:1.27 [0.75-2.16], p = .38, I = 19.2%) but increased vascular complication compared with no MCS (OR:1.92 [1.01-3.64], p = .045, I = 1.5%).
Conclusions
Neither Impella nor IABP decreased all-cause short-term mortality when compared with no MCS for high-risk PCI and/or CS. Moreover, Impella increased major bleeding compared with no MCS.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 06 Sep 2020; epub ahead of print

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: 20 Oct 2020; epub ahead of print

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 CHADS 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 CHADS score was identified as one of the independent predictors of silent embolism (OR = 5.584; 95%CI: 1.516-20.566; p = .010), and CHADS 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
CHADS 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: 20 Oct 2020; epub ahead of print

Left coronary artery calcification patterns after coronary bypass graft surgery: An in-vivo optical coherence tomography study.

Wolny R, Mintz GS, Matsumura M, Kim SY, ... Shlofmitz RA, Maehara A
Objectives
We sought to evaluate the severity and patterns of calcifications in the left main coronary artery (LMCA) and proximal segments of left anterior descending coronary artery (LAD) and left circumflex artery (LCX) using optical coherence tomography (OCT) in patients with and without prior coronary artery bypass grafting (CABG).
Background
CABG may accelerate upstream calcium development.
Methods
OCT images (n = 76) of the LMCA bifurcation from either the LAD or LCX in 76 patients with at least one patent left coronary graft, on average 7.0 ± 5.6 years post-CABG, were compared with 148 OCT images in propensity-score-matched non-CABG controls.
Results
Minimum lumen areas in the LMCA, LAD, and LCX in post-CABG patients were smaller than non-CABG controls. Maximum calcium arc and thickness as well as calcium length were greater in the LMCA and LCX, but not in the LAD in post-CABG patients versus non-CABG controls. Calcium located at the carina of a bifurcation, calcified nodules (CN), thin intimal calcium, and lobulated calcium were more prevalent in post-CABG patients. After adjusting for multiple covariates, prior CABG was an independent predictor of calcification at the carina of a bifurcation (odds ratio [OR] 5.77 [95% confidence interval, CI: 1.5-21.6]), thin intimal calcium (4.7 [1.5-14.4]), and the presence of a CN (15.60 [3.2-76.2]).
Conclusions
Prior CABG is associated with greater amount of calcium in the LMCA and the proximal LCX, as well as higher prevalence of atypical calcium patterns, including CN, thin or lobulated calcium, and calcifications located at the carina of a bifurcation, compared with non-CABG controls.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 10 Sep 2020; epub ahead of print

Incidence and predictors of delirium on the intensive care unit after acute myocardial infarction, insight from a retrospective registry.

Jäckel M, Zotzmann V, Wengenmayer T, Duerschmied D, ... Bode C, Staudacher DL
Objectives
This study aimed to identify the incidence and potential risk factors for delirium after myocardial infarction (MI).
Background
Delirium is a common complication on intensive care units. Data on incidence and especially on predictors of delirium in patients after acute MI are rare.
Methods
In this retrospective study, all patients hospitalized for MI treated with coronary angiography in an university hospital in 2018 were included and analyzed. Onset of delirium within the first 5 days after MI was attributed to the MI and was defined by a Nursing Delirium screening scale (NuDesc) ≥2. This score is taken as part of daily care in every patient on intensive care unit three times a day by especially trained nurses.
Results
A total of 624 patients with MI (age 68.5 ± 13.2 years, ST-elevation MI 41.6%, hospital mortality 3.2%) were included in the study. Delirium was detected in 10.9% of all patients. In the subgroup of patients with a stay on the intensive care unit (ICU) for more than 24 hr (n = 229), delirium was detected in 29.7%. Hospital and ICU stay were significantly longer in patients with delirium (p < .001). Delirium was an independent predictor of prolonged ICU-stay. Independent predictors of delirium were age, dementia, alcohol abuse, cardiac arrest, hypotension, and leucocytosis. Infarct size or presentation with ST-elevation were not associated with incidence of delirium.
Conclusion
Development of delirium is frequent after acute MI and prolongs hospitalization. Incidence of delirium is associated with clinical instability, preexisting comorbidity, and age rather than MI type or size.

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

Catheter Cardiovasc Interv: 13 Sep 2020; epub ahead of print

Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus: The OCEAN-TAVI registry.

Hase H, Yoshijima N, Yanagisawa R, Tanaka M, ... Hayashida K,
Objectives
To compare safety, efficacy, and hemodynamics of transfemoral transcatheter aortic valve replacement (TAVR) using self-expanding and balloon-expandable transcatheter heart valves (THVs) in patients with a small aortic annulus.
Background
Few studies have directly compared TAVR outcomes using third-generation THVs, focusing on patients with small aortic annuli.
Methods
In a multicenter TAVR registry, we analyzed data from 576 patients with a small annulus and who underwent transfemoral TAVR using third-generation THVs. Propensity score matching was used to adjust baseline clinical characteristics.
Results
The device success rate in the overall cohort was 92.0% (Evolut R: 92.1% vs. Sapien 3:92.0%, p = 0.96). One year after TAVR, patients treated with Evolut R maintained a lower mean pressure gradient (mPG) and a higher indexed effective orifice area (iEOA) in the matched cohort {mPG: 9.0 [interquartile range (IQR): 6.0-11.9] vs. 12.0 [IQR: 9.9-16.3] mmHg, p < .001; iEOA: 1.20 [IQR: 1.01-1.46] vs. 1.08 [IQR: 0.90-1.28] cm /m , p < .001}. However, no significant differences were reported in the incidence of severe prosthesis-patient mismatch and aortic regurgitation at 1 year. Furthermore, both groups showed comparable outcomes with no differences in terms of all-cause mortality (log-lank test, p = .81).
Conclusions
TAVR for patients with a small annulus using third-generation THVs was associated with high device success. Evolut R seems to be superior to Sapien 3 in hemodynamic performance for patients with a small annulus and body surface area up to 1 year after TAVR. Nevertheless, all-cause mortality at 1 year was similar between both groups.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 13 Sep 2020; epub ahead of print

Percutaneous large-bore axillary access is a safe alternative to surgical approach: A systematic review.

Southmayd G, Hoque A, Kaki A, Tayal R, Rab ST
Objectives
To systematically review relevant literature regarding cardiovascular outcomes of large-bore axillary arterial access via percutaneous and surgical approaches.
Background
In patients with severe peripheral arterial disease (PAD) undergoing cardiac interventions, large-bore femoral access may be prohibitive. The axillary artery provides an alternative vascular access for transcatheter aortic valve replacement (TAVR) or mechanical circulatory support. There have been limited comparisons of percutaneous transaxillary (pTAX) approach with the more traditional surgical transaxillary (sTAX) approach.
Methods
Pubmed and Medline databases were queried through January 2019 for studies describing pTAX or sTAX approaches with TAVR or Impella insertion. Primary outcomes were access-related mortality, 30-day mortality, stroke, major vascular complications, and major bleeding.
Results
One hundred and fifty five studies were reviewed, with additional unpublished data from 1 institution. Twenty-two studies met the inclusion criteria. Patient data was heterogeneous, with 69% TAVR and 31% Impella use in the pTAX group, and 96% TAVR and 4% Impella use in the sTAX group. There was more cardiogenic shock in the pTAX group. When compared to surgical approach, the percutaneous approach had similar 30-day mortality for TAVR (5.6% vs 4.6%, OR non-significant) and Impella (43.4% vs 38.6%, OR non-significant), similar stroke rates (4.3% vs 4.2%, OR non-significant), similar major vascular complications (2.8% vs 2.3%, OR non-significant) and less major bleeding (2.7% vs 17.9%, OR significant).
Conclusions
Data suggests large-bore pTAX access has similar 30-day mortality, stroke rates, and major vascular complications as sTAX access, with less major bleeding. Additional studies are needed to validate results.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 13 Sep 2020; epub ahead of print

Bronchus compression relieved by patent ductus arteriosus stenting.

Zayed WM, Bhandari K, Guyon PW, El-Sabrout H, ... Moore JW, El-Said H
Background
Patent ductus arteriosus (PDA) stenting is evolving as an alternative to surgical aorto-pulmonary shunts for infants with ductal-dependent pulmonary blood flow. Given anatomical proximity, the PDA can compress the ipsilateral bronchus. We report a case series of four patients with bronchial compression by a tortuous PDA who underwent PDA stenting.
Methods
Our four patients received PDA stents for ductal-dependent pulmonary blood flow despite preprocedure imaging evidence of bronchial compression. We reviewed the cross-sectional chest imaging to assess the degree of bronchial compression and the variables that affect it, namely PDA size, PDA tortuosity, and the anatomical relationship between the compressed bronchus and the PDA.
Results
Three out of the four patients had postprocedure imaging, and all showed relief of the previously seen bronchial compression. Post-PDA stenting patients had a smaller and straight PDA with significant lateralization away from the compressed bronchus. None of the four patients developed symptoms of bronchial compression poststenting.
Conclusions
Our study suggests that pre-existing bronchial compression does not preclude PDA stenting. Stent placement in an engorged and tortuous PDA led to significant improvement in pre-existing bronchial compression. Improvement may be attributed to PDA shrinkage, straightening, and lateralization. Further studies are needed to confirm our findings.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 13 Sep 2020; epub ahead of print

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

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

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 15 Sep 2020; epub ahead of print

Intravascular lithotripsy in calcified-coronary lesions: A real-world observational, European multicenter study.

Aziz A, Bhatia G, Pitt M, Choudhury A, ... Rides H, Basavarajaiah S
Background
The recently introduced intravascular lithotripsy (IVL) appears promising and relatively safer than conventional approaches when dealing with calcified lesions. Although there are published reports on this novel technology, data from the real world are limited. In this study, we aim to report on the experience of IVL from a real-world population derived from six European centers that undertake high-volume complex coronary interventions.
Methods and results
We enrolled all patients treated with IVL between November 2018 and February 2020 at six centers. Procedural success and complications were assessed along with clinical outcomes, which included: cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularisation (TLR), and major adverse cardiac event (MACE) (composite of cardiac death, TVMI, and TLR). Hundred and ninety patients (200 lesions) with a mean age of 72 years were treated using IVL. Diabetes and chronic kidney disease were present in 50% (n = 95) and 16% (n = 30) of cases, respectively. Acute-coronary syndromes accounted for 91 (48%) of the cases. Most were de-novo lesions (77%; n = 154). Upfront use of IVL occurred in 26% of cases, while the rest were bail-out procedures due to inadequate predilatation with conventional balloons. Adjuvant rotational atherectomy was needed in 17% of cases. Procedural success was achieved in 99% of cases with a complication rate of 3%. During the median follow-up of 222 days, there was two cardiac deaths (1%), one case of TVMI (0.5%), 3 TLR (1.5%) taking the MACE rate to 2.6%.
Conclusion
Use of IVL appears to be safe and effective in dealing with calcified-coronary lesions. A high success rate was observed with low procedural complications and event rates.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 15 Sep 2020; epub ahead of print

Outcomes with catheter-directed thrombolysis compared with anticoagulation alone in patients with acute deep venous thrombosis.

Abraham B, Sedhom R, Megaly M, Saad M, ... Lalonde T, Attallah A
Objective
The authors aimed to investigate the benefits and risks of catheter-directed thrombolysis (CDT) in acute deep venous thrombosis (DVT).
Background
The role of CDT in the management of DVT is evolving. Data on CDT versus anticoagulation alone in acute DVT is sparse.
Methods
We performed a systematic review and meta-analysis of published studies that compared CDT to anticoagulation alone in patients with acute DVT.
Results
We included 11 studies (four randomized control trials [RCTs] and seven observational studies) with a total of 8,737 patients. During hospital stay, patients who received CDT had higher odds of major bleeding (2.5% vs. 1.6%; OR 1.46, 95% CI [1.07, 1.98], p = .02), blood transfusion (10.8% vs. 6.2%; OR 1.8, 95% CI [1.52, 2.13], p < .001), and thromboembolism (15.5% vs. 10%; OR 1.67, 95% CI [1.47, 1.91], p < .001) compared with anticoagulation alone. At 6-month follow-up, patients who received CDT had higher venous patency (71.1% vs. 37.7%; OR 5.49, 95% CI [2.63, 11.5], p < .001) and lower postthrombotic syndrome (PTS; 27% vs. 40.7%; OR 0.44, 95% CI [0.22, 0.86], p = .02). During a mean follow-up duration of 30.5 ± 28 months, CDT group continued to have higher venous patency (79.6% vs. 71.8%; OR 3.79, 95% CI [1.54, 9.32], p = .004) and lower PTS (44.7% vs. 50.5%; OR 0.43, 95% CI [0.23, 0.78], p = .006), but no difference in thromboembolism.
Conclusion
Compared with anticoagulation alone, CDT for patients with acute DVT was associated with a higher risk of complications, but a higher rate of venous patency and lower risk of postthrombotic syndrome at 2.5 years follow-up.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 15 Sep 2020; epub ahead of print

Dose-reducing fluoroscopic system decreases patient but not occupational radiation exposure in chronic total occlusion intervention.

Salinas P, Sanchez-Casanueva RM, Gonzalo N, A Gil J, ... Vaño E, Escaned J
Aims
Several novel low-dose fluoroscopic systems (LDS) developed recently, but real practice information of the net benefit for the patient and professionals is scarce. We evaluated separately patient and operator radiation exposure during percutaneous interventions of chronic total occlusions (CTO).
Methods
A total of 116 consecutive CTOs were analyzed (60 in LDS and 56 in standard-dose fluoroscopic system [SDS]). Digital dosimetry of patient and occupational (operator and scatter dose) exposure was prospectively recorded.
Results
Biometrics, demographics, CTO variables, and operators were distributed evenly. Patient radiation exposure was effectively decreased in LDS (dose area product [DAP] by 36%, Air Kerma [AK] by 47%). However, occupational data showed no statistical differences between LDS and SDS. The LDS uses less radiation amount but with higher energy (due to additional filtration) compared to SDS, therefore increasing the scatter dose. When comparing the C-arm scatter dose to the DAP we found higher scatter dose with the LDS (0.0139 mSv/gray (Gy)*cm2 vs. 0.0082 mSv/Gy*cm2, p < .001). This was confirmed in a larger dataset comprising 5,221 coronary procedures.
Conclusions
LDS was safer for patients reducing DAP and AK compared to SDS. However, occupational doses were not lower and scatter dose higher. Radiological protection measures must be kept maximized even in LDS.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Sep 2020; epub ahead of print

Evaluation of mortality following paclitaxel drug-coated stent angioplasty of femoropopliteal lesions in real world.

Böhme T, Noory E, Beschorner U, Jacques B, ... Neumann FJ, Zeller T
Objectives
To evaluate the long-term mortality after paclitaxel-coated drug-eluting stent (DES) angioplasty and use of uncoated devices of femoropopliteal lesions in real world practice.
Background
A meta-analysis of randomized controlled trials reported an increased risk of long-term mortality after femoropopliteal angioplasty with paclitaxel-coated devices.
Methods
Retrospective mortality analysis of claudicants Rutherford-Becker class (RBC) 1-4 who underwent DES angioplasty or uncoated balloon or stent angioplasty of femoropopliteal lesions with a follow-up of 3-7 years.
Results
From 2010 to 2016 8,377 patients were treated with femoropopliteal lesions. This analysis included 599 patients. Three-hundred-three patients were treated with an uncoated device and 296 patients with a DES. The mean follow-up period was 51.80 ± 23.40 months (range 0-84). For the entire cohort mortality incidence was 32.3% after uncoated treatment and 22.6% after DES (p < .033). For the entire cohort multivariate logistic regression analysis revealed age (p < .001), diabetes mellitus (p = .010), renal insufficiency (p = .001) and RBC 4 (p < .001) as independent predictors for mortality. After propensity score matching mortality incidence was 32.5% after uncoated treatment and 24.1% after DES (p = .264). After propensity score matching, independent mortality predictors were age (p < .001), hyperlipidemia (p = .035), diabetes mellitus (p = .018) and RBC 4 (p < .001). Kaplan-Meier analysis showed that higher paclitaxel dosage was associated with lower mortality.
Conclusion
In real world, long-term mortality rate was lower after DES angioplasty than after treatment with uncoated devices. Mortality predictors were co-morbidities, risk factors, and disease severity.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Oct 2020; 96:1306-1314

Amplatzer left atrial appendage closure: Single versus combined procedures.

Kleinecke C, Buffle E, Link J, Häner J, ... Meier B, Gloekler S
Objectives
This study compares procedural and late clinical outcomes of left atrial appendage closure (LAAC) with Amplatzer devices as a single versus a combined procedure with other structural or coronary interventions.
Background
Multiple cardiac conditions are frequent among elderly patients and invite simultaneous treatment to ensure a favorable patient outcomes.
Methods
559 consecutive patients (73.3 ± 11.1 years) underwent LAAC with Amplatzer devices at two centres (Bern and Zurich university hospitals, Switzerland) either as a single procedure or combined with other interventions. The primary safety endpoint was a composite of major peri-procedural complications and major bleeding at follow-up, the primary efficacy endpoint included stroke, systemic embolism, and cardiovascular/unexplained death. All event rates are reported per 100 patient-years.
Results
In 263 single and 296 combined procedures with percutaneous coronary interventions (47.6%), closure of an atrial septal defect (8.4%) or a patent foramen ovale (36.5%), transcatheter aortic valve implantation (10.1%), mitral clipping (4.1%), atrial fibrillation ablation (8.8%), or another procedure (3.0%) were analyzed. Device success (96.6% [single] vs. 99.0% [combined], p = .08) did not differ between the groups. After a mean follow-up of 2.6 ± 1.5 vs. 2.5 ± 1.5 years and a total of 1,422 patient-years, the primary efficacy (40/677, 5.9% [single] vs. 37/745, 5.0% [combined]; HR, 1.2, 95% CI, 0.8-1.9, p = .44), as well as the primary safety endpoint (25/677, 3.7% vs 28/745, 3.8%; HR, 1.0, 95% CI, 0.6-1.8, p = .89) were comparable.
Conclusions
LAAC with Amplatzer devices combined with structural, coronary, and electrophysiological procedures offers procedural feasibility and safety, as well as long-term efficacy.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Sep 2020; epub ahead of print

Efficacy of the novel inner PIERCE technique for severely calcified below-the-knee occlusions in a patient with chronic limb-threatening ischemia.

Nakama T, Muraishi M, Obunai K, Watanabe H

A severely calcified lesion is the most challenging entity in endovascular therapy (EVT) for below-the-knee (BTK) arteries. In this report, we introduce a challenging plaque modification technique known as the inner PIERCE technique. A 65-year-old man on hemodialysis with multiple toe ulcerations underwent an EVT for his BTK artery diseases. During EVT, the guidewire passed through the severely calcified posterior tibial and plantar arteries; however, the other devices could not pass through the lesion. Therefore, a novel inner PIERCE technique was performed. After guidewire externalization, an 18G 20 cm needle was advanced from the retrograde approach site, following the guidewire, for percutaneous transhepatic cholangiodrainage (PTCD). The PTCD needle was advanced into the severely calcified plaque using a rotational motion. Finally, the needle could pass through the lesion. After the inner PIERCE technique, an angioplasty was performed with a 2.5 mm balloon. The final angiography showed sufficient blood flow. After the EVT, complete wound healing was achieved in 4 months. This challenging technique may be an additional option for EVT to treat severely calcified BTK arteries.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Oct 2020; 96:1317-1322

Nanospheres encapsulated everolimus delivery into arterial wall-the tissue pharmacokinetics and vascular response experimental study.

Milewski K, Bryła-Wojciechowska A, Buszman PP, Jelonek K, ... Kasperczyk J, Buszman PE
Objective
This study aimed to evaluate the pharmacokinetic profile and tissue effects of everolimus delivered into arterial wall using biodegradable nanospheres.
Background
Delivery of everolimus into the arterial wall is challenging due to its low-lipophilic profile.
Methods
A pharmacokinetic study included 28 porcine coronary arterial segments initially injured with balloon angioplasty followed by the local delivery of everolimus encapsulated in nanospheres (EEN) via injection through a microporous delivery catheter. The animals were sacrificed at 1 hour, 1,7,28, and 90-day follow-up. In the tissue effects study 16 coronary bare metal stent (BMS) were implanted following EEN delivery, 15 BMS following nanospheres delivery without the drug (reference group) and 16 implanted BMS served as a control. Angiographic and histology follow-up was scheduled at 28 and 90-day.
Results
The study showed high-everolimus concentrations in arterial tissue early after nanoparticles delivery followed by its gradual decrease to 1.15 ± 0.40 ng/mg at 90 days. Histology analysis showed favorable biocompatibility and healing profile with comparable area stenosis between groups at both time-points.
Conclusions
The present study demonstrates for the first time the safety, biocompatibility, and long-term retention of everolimus in arterial tissue after single local delivery of biodegradable nanospheres.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 17 Sep 2020; epub ahead of print

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

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

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 17 Sep 2020; epub ahead of print

Papillary muscle rupture after transcatheter aortic valve implantation.

Morita Y, Endo A, Tanabe K

Catheter-induced mitral regurgitation (MR) caused by mitral papillary muscle rupture can be a fatal complication of transcatheter aortic valve implantation (TAVI). We report a case involving an 89-year-old man who presented with symptomatic severe aortic stenosis. In addition, preoperative echocardiography showed accessory mitral valve tissue. Although moderate MR developed immediately after TAVI, severe MR caused by anterolateral papillary muscle rupture occurred 3 months after TAVI. As only a few case series have been published, our case report adds to the evidence base for this treatment strategy.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 22 Sep 2020; epub ahead of print

Hemodynamic comparison of transcatheter aortic valve replacement with the SAPIEN 3 Ultra versus SAPIEN 3: The HomoSAPIEN registry.

Moriyama N, Lehtola H, Miyashita H, Piuhola J, Niemelä M, Laine M
Objectives
The study aims to compare the hemodynamic and clinical outcomes of the SAPIEN 3 Ultra (S3-Ultra) with the SAPIEN 3 (S3) system in patients who underwent transfemoral transcatheter aortic valve replacement (TF-TAVR).
Background
The new balloon-expandable S3-Ultra system incorporates new features to reduce paravalvular leakage (PVL). However, the data after the S3-Ultra implantation is very limited.
Methods
A total of 282 consecutive patients who underwent TF-TAVR with the S3-Ultra and the S3 were evaluated. The primary outcome of this study was to compare the incidence of ≥mild PVL after the S3-Ultra and S3 implantation.
Results
Between June 2017 and November 2019, 141 patients with the S3-Ultra and 141 patients with the S3 were identified with similar baseline and preprocedural imaging characteristics (mean age: 79.6 ± 6.7 years and mean aortic annulus area: 492.5 ± 91.2 mm ). In total, 83 patients (29.4%) were treated with 29-mm valve. Predischarge echocardiography demonstrated a significantly lower incidence of ≥mild PVL (the total cohort: 7.2 vs. 22.3%, p < .001, and the cohort excluding 29-mm valve: 4.0 vs. 21.4%, p = .03) for the S3-Ultra. The S3-Ultra system, especially 20-, 23-, and 26-mm valve, was associated with significantly lower risk of ≥mild PVL compared with the S3 system in multivariate analysis. There were no significant differences in clinical outcomes at 30-day between these groups, except for the lower incidence of major vascular complication (4.5 vs. 11.4%, p = .05) in patients with the S3-Ultra.
Conclusions
In this registry, the S3-Ultra system performed superiorly to the S3, as demonstrated by reduced ≥mild PVL, with comparable safety.

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

Catheter Cardiovasc Interv: 22 Sep 2020; epub ahead of print

Standardized fractal bench test evaluation of coronary stents: Performances in bifurcation lesions treated by the re-proximal optimization technique.

Piriou PG, Bonin M, Huchet F, Letocart V, ... Jordana F, Guerin P
Background
Bifurcation lesions in coronary arteries are complex to treat with coronary stents, which are not designed for that purpose and can be unproperly deployed. Moreover, devices are constantly evolving, and so are angioplasty techniques.
Objectives
The aim of this study was to determine the performances of different stents in the treatment of bifurcation lesions using the re-proximal optimization technique (rePOT).
Methods
Eleven stent platforms were evaluated: Xience Sierra (Abbott), Xience Alpine (Abbott), Synergy (Boston), Coroflex Isar (Bbraun), Cobra PzF (Celonova), Ultimaster (Terumo), Resolute Integrity (Medtronic), Resolute Onyx (Medtronic), Optimax (Hexacath), Orsiro (Biotronik), and Absorb (Abbott). Stents were deployed in a silicone fractal bifurcation model using the rePOT. Micro-computed tomography was performed to assess side branch ostium coverage and strut malapposition, as well as the effect of rePOT on stent cell area.
Results
Our study showed significant differences between stent platforms regarding side branch ostium coverage (p = .002). The Synergy and Cobra PzF stents were the most performant devices to avoid ostium coverage. Strut malapposition varied significantly between devices (p = .008) but the percentage of malapposed struts was relatively low. Significant differences were observed between stents regarding the cell area before (p = .002) and also after rePOT (p = .003), and the increase in cell area caused by rePOT varied considerably between devices (p = .08).
Conclusion
This study highlighted significant differences in the performances of stent platforms deployed in a fractal bifurcation model using rePOT, with a variable impact of the procedure on stent cell area.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 22 Sep 2020; epub ahead of print

One-year clinical outcomes in patients with chronic kidney disease treated with COMBO stents: From the COMBO collaboration.

Chandrasekhar J, Kalkman DN, Sartori S, Baber U, ... Mehran R,
Background
Chronic kidney disease (CKD) patients undergoing percutaneous coronary intervention (PCI) experience greater ischemic events including clinically driven target lesion revascularization (CD-TLR). Whether the COMBO biodegradable-polymer sirolimus-eluting stent promotes better outcomes in these patients by virtue of endothelial progenitor cell capture technology is unknown.
Objective
We examined one-year outcomes by CKD status from the COMBO collaboration.
Methods
The COMBO collaboration was a patient-level pooled dataset from the REMEDEE and MASCOT registries (3,614 patients) of all-comers undergoing attempted COMBO stent PCI. The primary endpoint was one-year target lesion failure (TLF), composite of cardiac death, target-vessel myocardial infarction (TV-MI) or CD-TLR. Secondary endpoints included stent thrombosis (ST).
Results
The study included 6.4% (n = 231) CKD and 93.6% (n = 3,361) non-CKD patients. CKD patients were older and included more women with greater prevalence of several comorbidities but similar rate of acute coronary syndrome (50.6% vs. 54.5%, p = .26). CKD patients underwent radial PCI less often (56.1% vs. 70.3%, p < .001) and received clopidogrel (78.6% vs. 68.3%) more often (p = .004). One-year TLF occurred in 7.9% CKD vs. 3.7% non-CKD patients, p = .001. CKD patients also demonstrated greater incidence of cardiac death (6.2% vs. 1.2%, p < .0001), TV-MI (2.7% vs. 1.1%, p = .04) but similar CD-TLR (2.7% vs 2.2%, p = .61) and definite/probable ST (1.4% vs. 0.8%, p = .42), compared to non-CKD patients.
Conclusions
CKD patients treated with COMBO stents had significantly greater incidence of one-year TLF compared to non-CKD patients driven by cardiac death and to a lesser extent TV-MI but not CD-TLR. They had similar rates of definite/probable ST.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 15 Sep 2020; epub ahead of print

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

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

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 10 Nov 2020; epub ahead of print

Potential risk of perioperative thromboembolism in patients with antiphospholipid syndrome who undergo transcatheter aortic valve implantation: A case series.

Hoshi T, Hiraya D, Sato A, Ieda M

Antiphospholipid syndrome (APS) is an autoimmune disease characterized by a positive serum antiphospholipid antibody status. Patients with APS usually have an underlying hypercoagulable state, which can increase the risk of perioperative thromboembolism. We describe three patients with APS who underwent transcatheter aortic valve implantation for symptomatic severe aortic stenosis. Of them, two had complicated cerebrovascular events, and the other had no complications. Careful antithrombotic management is essential to minimize the risk of thromboembolism and bleeding in patients with APS.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 24 Sep 2020; epub ahead of print

Early experience with the Micro Plug Set for preterm patent ductus arteriosus closure.

Heyden CM, El-Said HG, Moore JW, Guyon PW, Katheria AC, Ratnayaka K
Objectives
We intend to describe early experience using a new, commercially available Micro Plug Set for preterm neonate and infant transcatheter patent ductus arteriosus (PDA) occlusion.
Background
Transcatheter PDA occlusion in premature neonates and small infants is safe and effective. The procedure is early in its evolution.
Methods
Procedural and short-term outcomes of preterm neonates and infants undergoing transcatheter PDA occlusion with a new, commercially available device were reviewed.
Results
Eight preterm neonates and infants born at median 27 weeks gestation (23-36 weeks) underwent transcatheter PDA device closure with the Micro Plug Set. The device is short (2.5 mm) with a range of diameters (3, 4, 5, 6 mm) and delivered through a microcatheter. Procedures were performed at median 41 days of age (12-88 days) and at 1690 g (760-3,310 g). Transvenous PDA device occlusion was performed with fluoroscopic and echocardiography guidance. All procedures were successful with complete PDA occlusion. There were no procedural or short-term adverse events.
Conclusions
Preterm neonate and infant transcatheter PDA device closure with a new, commercially available short and microcatheter delivered device (Micro Plug Set) was safe and effective in a small, early series of patients.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 25 Sep 2020; epub ahead of print

Hybrid treatment of aortic aneurism, type-A dissection, and aortic valve stenosis.

Lunardi M, Franzese I, Faggian G, Ribichini FL

Hybrid multidisciplinary interventions are attractive care options for heart valve and vascular diseases in high-risk patients. We describe the feasibility of staged hybrid aortic arch repair to treat a type Ia endoleak and transcatheter aortic valve replacement to treat an aortic valve stenosis, achieving an escape strategy to treat an unexpected type-A aortic dissection.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 25 Sep 2020; epub ahead of print

A safe and simple method for axIABP placement using a left axillary-radial technique.

Maatman B, Rios-Meza H, Guglin M, Revtyak G

In patients with severe heart failure, a percutaneous axillary intraaortic balloon pump (axIABP) may permit ambulation while awaiting destination therapy. Traditionally, an \"axillary-femoral\" approach has been used with femoral access for axillary angiography during insertion. We describe an \"axillary-radial\" technique for axIABP insertion and removal using the left radial artery.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 25 Sep 2020; epub ahead of print

Common carotid artery endovascular clamping for neuroprotection during carotid stenting: Flow-gate system as an innovative treatment approach.

Gabrielli R, Castrucci T, Siani A, Accrocca F, ... Cancellieri R, Bartoli S
Objectives
We here report our clinical experience in CAS management through common carotid artery endovascular clamping with FlowGate2 system.
Methods
Forty-five patients were enrolled with de novo asymptomatic internal carotid artery stenosis ≥70%. Cerebral protection during the stenting procedure was achieved using a unique endovascular clamping technique developed in our Institution which includes: (a) the occlusion of the common carotid artery only, through inflatable balloons integrated in the FlowGate2 Balloon Guide Catheter system; (b) flow inversion connecting catheter to 16 G blood cannula previously placed in arm vein; (c) after the placement of the stent, the flow inversion is maintained for 30 s to allow debris washout. The related primary end-point was the rate of Diffusion-weighted imaging magnetic resonance (DWI) micro-embolic scattering of infarction. The patient\'s clinical and the neurological status were assessed prior, during and after intervention, at discharge.
Results
Transient clamping intolerance was observed in two patients (2/45; 4%). One minor stroke (1/45; 2%) occurred 8 hr the procedure with DWI ipsilateral micro-embolic lesions. No major strokes or deaths were observed at 3 months follow-up. DWI demonstrated ipsilateral micro-embolic scattering of infarction, in one asymptomatic patient. In all patients, no worst changes in NIHSS scale assessment were recorded at 1, 3, and 6 months.
Conclusions
Our data confirmed the efficacy of FlowGate2 in terms of neuroprotection during CAS. To our knowledge, these are the first published data on this innovative approach developed in our institution. A large controlled trial is ongoing to confirm preliminary evidences.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 27 Sep 2020; epub ahead of print

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: 28 Sep 2020; epub ahead of print

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

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

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Sep 2020; epub ahead of print

Intracardiac echocardiographic-guided right-sided cardiac biopsy: Case series and literature review.

Pearman JL, Wall SL, Chen L, Rogers JH

Endomyocardial biopsy (EMB) is a common procedure used to aid in the diagnosis of diffuse myocardial diseases and, less commonly, in the diagnosis of cardiac tumors. As cardiac tumors are often found in high-risk locations (ventricular free wall or atria), precision biopsy is paramount, and additional imaging, like transesophageal echocardiography is often required for guidance. The use of intracardiac echocardiography (ICE) to guide biopsy has been described, but there is no consensus on a standardized approach. We report our institutional approach with three cases of ICE-directed EMB performed with the 2.4 mm Jawz bioptome directed with an 8.5-Fr Agilis NxT steerable introducer. All cases were performed under guidance with the AcuNav ICE probe. There were no procedural complications and a definitive diagnosis was obtained in all three cases. We also review the available published cases of ICE-guided EMB in the literature-noting the different procedural approaches, complication rate, and diagnostic yield. There were only two negative biopsies reported among the published cases and no reported complications. Our review of all these cases suggests that ICE-guidance for EMB is superior to other forms of imaging in its ease of use and high definition of right-sided cardiac structures. We also feel that the use of the Agilis steerable sheath allows for more precise directing of the bioptome and is a critical component in performing a successful targeted biopsy.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Sep 2020; epub ahead of print

Impact of cleft-like indentations on procedural outcome of percutaneous edge-to-edge mitral valve repair.

Körber MI, Friedrichs KP, Aydin F, Pfister R, ... Rudolph V, Huntgeburth M
Objectives and background
Percutaneous edge-to-edge mitral valve (MV) repair (PMVR) is broadly applied in high-risk patients with relevant mitral regurgitation (MR). We investigated the incidence of cleft-like indentations (CLI) and their impact on PMVR.
Methods and results
In a retrospective single center analysis including 263 patients undergoing PMVR with the MitraClip®-system between 11/2012 and 7/2016, MV anatomy was assessed by 3-dimensional transesophageal echocardiography. CLI were present in 37/263 patients (14.1%). Of these, 62.2% had 1 CLI, 27% had 2 CLI, and 10.8% had 3 CLI, mostly concerning segment P2 or P2/3 of the MV. Baseline characteristics were similarly distributed. Interestingly, most patients with CLI suffered from secondary MR (n = 29, 78%). The number of deployed MitraClips was higher in patients with CLI (2 [1.25-2] vs. 2 [1, 2], p = .035), whereas procedural as well as clinical success was similar: MR grade (1.2 vs. 1.5, p = .061), vena contracta width (4.2 vs. 4.5 mm, p = .293), dPmean (4.2 vs. 4.0 mmHg, p = .618) at discharge and NYHA class at 30 days did not differ between groups. Periprocedural complications were rare and equally distributed between groups. At 30 days, MR reduction persisted in patients with CLI (95.8% of these selected patients had a MR grade ≤ 2).
Conclusions
CLI of the MV are common in patients undergoing PMVR, also when presenting mainly with secondary MR. While the number of clips needed to address MR is slightly higher in patients with CLI, procedural success rates appear not to be affected. PMVR seems to be a safe treatment option for patients with CLI.

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

Catheter Cardiovasc Interv: 30 Sep 2020; epub ahead of print