Journal: Circ Cardiovasc Interv

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Abstract

Pregnancy in the Cardiac Catheterization Laboratory: A Safe and Feasible Endeavor.

Cheney AE, Vincent LL, McCabe JM, Kearney KE
Concerns over radiation exposure are ubiquitous to all interventional cardiologists; however, fear of exposure during childbearing years disproportionately deters women from entering the field. This review summarizes the available data on occupational radiation exposure during pregnancy with an emphasis on radiation quantification, the impact of exposure at various stages of fetal development, societal recommendations for safe levels of exposure during gestation, threshold levels necessary to induce fetal harm, and safe practices for the pregnant interventionalist. Reconciling the available information, we conclude that pregnancy in the cardiac catheterization laboratory is both safe and feasible. This review also highlights new technologies that may augment standard radiation safety techniques and are of particular interest to the pregnant interventional cardiologist. Finally, we propose steps to improve female representation in this field, underscoring the importance of a sex-balanced workforce.



Circ Cardiovasc Interv: 30 Mar 2021; 14:e009636
Cheney AE, Vincent LL, McCabe JM, Kearney KE
Circ Cardiovasc Interv: 30 Mar 2021; 14:e009636 | PMID: 33877865
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Abstract

Mid-Term Outcomes Following Percutaneous Pulmonary Valve Implantation Using the \"Folded Melody Valve\" Technique.

Jalal Z, Valdeolmillos E, Malekzadeh-Milani S, Eicken A, ... Thambo JB, Boudjemline Y
Background
The folded valve is a manual shortening of the Melody device, which has been validated as a valuable therapeutic option for the management of dysfunctional right ventricular outflow tracts needing a short valved stent. In this article, we aimed to evaluate, in a multicenter cohort, the mid-term outcomes of patients in whom a percutaneous pulmonary valve implantation was performed using the folded valve technique.
Methods
A 2012 to 2018 retrospective multicenter study was performed in 7 European institutions. All patients who benefit from percutaneous pulmonary valve implantation with a folded Melody valve were included.
Results
A total of 49 patients (median age, 19 years [range 4-56], 63% male) were included. The primary percutaneous pulmonary valve implantation indication was right ventricular outflow tract stenosis (n=19; 39%), patched native right ventricular outflow tracts were the most common substrate (n=15; 31%). The folded technique was mostly used in short right ventricular outflow tracts (n=28; 57%). Procedural success was 100%. After a median follow-up of 28 months (range, 4-80), folded Melody valve function was comparable to the immediate postimplantation period (mean transvalvular peak velocity=2.6±0.6 versus 2.4±0.6 m/s, P>0.1; only 2 patients had mild pulmonary regurgitation). Incidence rate of valve-related reinterventions was 2.1% per person per year (95% CI, 0.1%-3.9%). The probability of survival without valve-related reinterventions at 36 months was 90% (95% CI, 76%-100%).
Conclusions
The folded Melody valve is a safe technique with favorable mid-term outcomes up to 6.5 years after implantation, comparable with the usual Melody valve implantation procedure. Complications and reinterventions rates were low, making this technique relevant in selected patients.



Circ Cardiovasc Interv: 16 Mar 2021:CIRCINTERVENTIONS120009707; epub ahead of print
Jalal Z, Valdeolmillos E, Malekzadeh-Milani S, Eicken A, ... Thambo JB, Boudjemline Y
Circ Cardiovasc Interv: 16 Mar 2021:CIRCINTERVENTIONS120009707; epub ahead of print | PMID: 33726503
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Abstract

Clopidogrel Versus Ticagrelor or Prasugrel After Primary Percutaneous Coronary Intervention According to CYP2C19 Genotype: A POPular Genetics Subanalysis.

Claassens DMF, Bergmeijer TO, Vos GJA, Hermanides RS, ... Deneer VHM, Ten Berg JM
Background
Guidelines favor ticagrelor or prasugrel over clopidogrel in patients with myocardial infarction. However, the POPular Genetics trial (Patient Outcome After Primary Percutaneous Coronary Intervention [PCI]) showed that in patients with primary PCI, a CYP2C19 genotype-guided strategy was associated with a lower bleeding risk without increasing thrombotic risk, compared with routine ticagrelor/prasugrel treatment. Nevertheless, optimal P2Y12 inhibitor treatment in specific CYP2C19 genetic subgroups is still a subject of debate.
Methods
A prespecified subanalysis of the POPular Genetics trial was performed, using patients in whom CYP2C19*2, *3, and *17 genotypes was determined. Two different analyses were planned. The first assessed the effect of the CYP2C19*17 allele in clopidogrel-treated patients. The second compared the effect of clopidogrel in noncarriers of a loss-of-function allele with ticagrelor/prasugrel-treated patients, irrespective of CYP2C19 genotype. Main outcomes were a thrombotic outcome (cardiovascular death, myocardial infarction, stent thrombosis, and stroke) and a bleeding outcome (PLATO [Platelet Inhibition and Patient Outcomes] major and minor bleeding) after 12 months.
Results
A total of 2429 patients were used for analyses. In the first analysis, the CYP2C19*17 polymorphism was not found to have a significant influence on thrombotic (adjusted hazard ratio, 0.95 [95% CI, 0.45-2.02]) or bleeding outcomes (adjusted hazard ratio, 0.74 [95% CI, 0.48-1.18]). In the second analysis, clopidogrel was associated with a lower number of bleeding events compared with ticagrelor/prasugrel (9.9% versus 11.7%, adjusted hazard ratio, 0.74 [95% CI, 0.56-0.96]), without a significant increase in thrombotic events (3.4% versus 2.5%, adjusted hazard ratio, 1.14 [95% CI, 0.68-1.90]).
Conclusions
In patients with primary PCI not carrying a CYP2C19 loss-of-function allele, the use of clopidogrel compared with ticagrelor or prasugrel was associated with lower bleeding rates, without an increase in thrombotic events. No effect on clinical outcomes was found for the CYP2C19*17 polymorphism.
Registration
URL: https://www.clinicaltrials.gov; Unique identifier: NCT01761786. URL: https://www.trialregister.nl/; Unique identifier: NL2872.



Circ Cardiovasc Interv: 15 Mar 2021:CIRCINTERVENTIONS120009434; epub ahead of print
Claassens DMF, Bergmeijer TO, Vos GJA, Hermanides RS, ... Deneer VHM, Ten Berg JM
Circ Cardiovasc Interv: 15 Mar 2021:CIRCINTERVENTIONS120009434; epub ahead of print | PMID: 33722066
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Abstract

Acute and Short-Term Outcomes of Percutaneous Transcatheter Mitral Valve Replacement in Children.

Maschietto N, Prakash A, Del Nido P, Porras D
Background
Despite the improvement of surgical techniques for mitral valve (MV) repair in children, mitral valve replacement (MVR) is sometimes still necessary. MVR and redo-MVR continue to be burdened by early postoperative mortality and long-term morbidity with only about 75% of these patients being alive or transplant-free 10 years after the initial MVR. Although transcatheter MVR (TMVR) is a well-established intervention in high surgical risk adults, only a few pediatric valve-in-valve case reports have been published. The purpose of this study was to describe our initial experience with the off-label use of the Sapien S3 valve for TMVR in a highly selected pediatric patient population.
Methods
We conducted a retrospective analysis of pediatric patients who underwent TMVR at Boston Children\'s Hospital between October 2018 and July 2020.
Results
Eight consecutive high surgical risk pediatric patients (median age, 9 years; range, 8-15) underwent TMVR (7 as valve-in-valve, 1 in a native MV). Each patient previously underwent multiple MV surgeries or MVR (median 4, range 2-5) and was highly symptomatic (Ross functional class 3 or 4). The indication for TMVR was mitral stenosis in 4 patients, regurgitation in 1, and mixed disease in 3. TMVR was successful in each patient, effectively reduced the left atrium and pulmonary hypertension (P=0.012 and 0.043 respectively), and was carried out without significant complications.
Conclusions
TMVR is an attractive alternative to MVR in high surgical risk patients. In this small series, TMVR was acutely effective and safe, with very encouraging early results.



Circ Cardiovasc Interv: 15 Mar 2021:CIRCINTERVENTIONS120009996; epub ahead of print
Maschietto N, Prakash A, Del Nido P, Porras D
Circ Cardiovasc Interv: 15 Mar 2021:CIRCINTERVENTIONS120009996; epub ahead of print | PMID: 33722065
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Abstract

Surgical Explantation of Transcatheter Aortic Valve Bioprostheses: A Statewide Experience.

Brescia AA, Deeb GM, Sang SLW, Tanaka D, ... Fukuhara S, Michigan Society of Thoracic and Cardiovascular Surgeons and the Blue Cross Blue Shield of Michigan Cardiovascular Consortium
Background
Despite the rapid adoption of transcatheter aortic valve replacement (TAVR) since its initial approval in 2011, the frequency and outcomes of surgical explantation of TAVR devices (TAVR-explant) is poorly understood.
Methods
Patients undergoing TAVR-explant between January 2012 and June 2020 at 33 hospitals in Michigan were identified in the Society of Thoracic Surgeons Database and linked to index TAVR data from the Transcatheter Valve Therapy Registry through a statewide quality collaborative. The primary outcome was operative mortality. Indications for TAVR-explant, contraindications to redo TAVR, operative data, and outcomes were collected from Society of Thoracic Surgeons and Transcatheter Valve Therapy databases. Baseline Society of Thoracic Surgeons Predicted Risk of Mortality was compared between index TAVR and TAVR-explant.
Results
Twenty-four surgeons at 12 hospitals performed TAVR-explants in 46 patients (median age, 73). The frequency of TAVR-explant was 0.4%, and the number of explants increased annually. Median time to TAVR-explant was 139 days and among known device types explanted, most were self-expanding valves (29/41, 71%). Common indications for TAVR-explant were procedure-related failure (35%), paravalvular leak (28%), and need for other cardiac surgery (26%). Contraindications to redo TAVR included need for other cardiac surgery (28%), unsuitable noncoronary anatomy (13%), coronary obstruction (11%), and endocarditis (11%). Overall, 65% (30/46) of patients underwent concomitant procedures, including aortic repair/replacement in 33% (n=15), mitral surgery in 22% (n=10), and coronary artery bypass grafting in 16% (n=7). The median Society of Thoracic Surgeons Predicted Risk of Mortality was 4.2% at index TAVR and 9.3% at TAVR-explant (P=0.001). Operative mortality was 20% (9/46) and 76% (35/46) of patients had in-hospital complications. Of patients alive at discharge, 37% (17/37) were discharged home and overall 3-month survival was 73±14%.
Conclusions
TAVR-explant is rare but increasing, and its clinical impact is substantial. As the utilization of TAVR expands into younger and lower-risk patients, providers should consider the potential for future TAVR-explant during selection of an initial valve strategy.



Circ Cardiovasc Interv: 14 Mar 2021:CIRCINTERVENTIONS120009927; epub ahead of print
Brescia AA, Deeb GM, Sang SLW, Tanaka D, ... Fukuhara S, Michigan Society of Thoracic and Cardiovascular Surgeons and the Blue Cross Blue Shield of Michigan Cardiovascular Consortium
Circ Cardiovasc Interv: 14 Mar 2021:CIRCINTERVENTIONS120009927; epub ahead of print | PMID: 33719506
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Abstract

Implications of Atrial Fibrillation on the Mechanisms of Mitral Regurgitation and Response to MitraClip in the COAPT Trial.

Gertz ZM, Herrmann HC, Lim DS, Kar S, ... Stone GW, Mack MJ
Background
Atrial fibrillation (AF), mitral regurgitation (MR), and left ventricular (LV) ejection fraction have a complex interplay. We evaluated the role of AF in patients with heart failure and moderate-to-severe or severe secondary MR enrolled in the randomized COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) and its impact on mechanisms and outcomes with the MitraClip.
Methods
Patients in the COAPT trial were stratified by the presence (n=327) or absence (n=287) of a history of AF and by assignment to treatment group. Clinical, echocardiographic, and outcome measures were assessed. The primary outcome was the composite rate of death or heart failure hospitalization at 24 months.
Results
Patients with history of AF were older and more often male. They had a higher LV ejection fraction, larger left atrial volumes and mitral valve orifice areas, smaller LV volumes, and similar MR severity. Patients with AF compared with those without a history of AF had a higher unadjusted (hazard ratio [HR], 1.32 [95% CI, 1.06-1.64], P=0.01) and adjusted (HR, 1.30 [1.03-1.64], P=0.03) 2-year rate of the primary outcome. Treatment with the MitraClip compared with guideline-directed medical therapy alone reduced death or heart failure hospitalization in both those with (HR, 0.61 [0.46-0.82]) and without (HR, 0.46 [0.33-0.66]) a history of AF (Pint=0.18). Treatment with the MitraClip was associated with a lower risk of stroke in patients with a history of AF (HR, 0.18 [0.04-0.86]) but not in those without a history of AF (HR, 1.64 [0.58-4.62]; Pint=0.02).
Conclusions
In the COAPT trial, patients with a history of AF had larger left atrial and mitral valve orifice areas with higher LV ejection fraction and smaller LV volumes, suggesting an atrial mechanism contribution to functional MR. Despite the worse prognosis of heart failure patients with a history of AF, MR reduction with the MitraClip still afforded substantial clinical benefits. Treatment with MitraClip was associated with a lower risk of stroke in patients with a history of AF.
Registration
URL: https://www.clinicaltrials.gov; Unique identifier: NCT01626079.



Circ Cardiovasc Interv: 14 Mar 2021:CIRCINTERVENTIONS120010300; epub ahead of print
Gertz ZM, Herrmann HC, Lim DS, Kar S, ... Stone GW, Mack MJ
Circ Cardiovasc Interv: 14 Mar 2021:CIRCINTERVENTIONS120010300; epub ahead of print | PMID: 33719505
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Abstract

Left Main Trifurcation and Its Percutaneous Treatment: What Is Known So Far?

Kovacevic M, Burzotta F, Elharty S, Besis G, ... Romagnoli E, Trani C
In humans, the most common anatomic variation of the left main (LM) stem is represented by its distal division in 3 branches (LM trifurcation) instead of 2. LM trifurcation disease accounts for ≈10% to 15% of all LM diseases and is often managed by cardiac surgery. Over the last decades, due to the improvement of interventional material and techniques, percutaneous coronary intervention started gaining acceptance to treat patients with LM disease including those with trifurcated anatomy. Yet, LM trifurcation stenosis with its intrinsic anatomic complexity (3 branches, at least 4 angles, wide variability in branch size and disease) is recognized as a challenging lesion subset for percutaneous coronary intervention. In this review, we summarize available data about LM trifurcation anatomy, its influence on percutaneous coronary intervention feasibility, and the evidence collected regarding the different technical options (including trissing balloon inflation).



Circ Cardiovasc Interv: 27 Feb 2021; 14:e009872
Kovacevic M, Burzotta F, Elharty S, Besis G, ... Romagnoli E, Trani C
Circ Cardiovasc Interv: 27 Feb 2021; 14:e009872 | PMID: 33685210
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Abstract

Time Delay, Infarct Size, and Microvascular Obstruction After Primary Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction.

Redfors B, Mohebi R, Giustino G, Chen S, ... Ben-Yehuda O, Stone GW
Background
Symptom-to-balloon time (SBT) and door-to-balloon time (DBT) are both considered important metrics in patients undergoing primary percutaneous coronary intervention (pPCI) for ST-segment-elevation myocardial infarction (STEMI). We sought to assess the relationship of SBT and DBT with infarct size and microvascular obstruction (MVO) after pPCI.
Methods
Individual patient data for 3115 ST-segment-elevation myocardial infarction patients undergoing pPCI in 10 randomized trials were pooled. Infarct size (% left ventricular mass) was assessed within 1 month after randomization by technetium-99 m sestamibi single-photon emission computerized tomography (3 studies) or cardiac magnetic resonance imaging (7 studies). MVO was assessed by cardiac magnetic resonance. Patients were stratified by short (≤2 hours), intermediate (2-4 hours), or long (>4 hours) SBTs, and by short (≤45 minutes), intermediate (45-90 minutes), or long (>90 minutes) DBTs.
Results
Median [interquartile range] SBT and DBT were 185 [130-269] and 46 [28-83] minutes, respectively. Median [interquartile range] time to infarct size assessment after pPCI was 5 [3-12] days. There was a stepwise increase in infarct size according to SBT category (adjusted difference, 2.0% [95% CI, 0.4-3.5] for intermediate versus short SBT and 4.4% [95% CI, 2.7-6.1] for long versus short SBT) but not according to DBT category (adjusted difference, 0.4% [95% CI, -1.2 to 1.9] for intermediate versus short DBT and -0.1% [95% CI, -1.0 to 3.0] for long versus short SBT). MVO was greater in patients with long versus short SBT (adjusted difference, 0.9% [95% CI, 0.3-1.4]) but was not different between patients with intermediate versus short SBT (adjusted difference, 0.1 [95% CI, -0.4 to 0.6]). There was no difference in MVO according to DBT. Results were similar in multivariable analysis with SBT and DBT included as continuous variables.
Conclusions
Among 3115 patients with ST-segment-elevation myocardial infarction undergoing infarct size assessment after pPCI, SBT was more strongly correlated with infarct size and MVO than DBT.



Circ Cardiovasc Interv: 30 Jan 2021; 14:e009879
Redfors B, Mohebi R, Giustino G, Chen S, ... Ben-Yehuda O, Stone GW
Circ Cardiovasc Interv: 30 Jan 2021; 14:e009879 | PMID: 33440999
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Abstract

Percutaneous Implantation of Adult Sized Stents for Coarctation of the Aorta in Children ≤20 kg: A 12-Year Experience.

Boe BA, Armstrong AK, Janse SA, Loccoh EC, ... Cheatham JP, Berman DP
Background
Stent implantation (SI) is more effective than balloon angioplasty for the treatment of coarctation of the aorta (CoA). Due to technical factors, balloon angioplasty is more commonly performed in small patients. We sought to evaluate outcomes of percutaneous adult sized SI for the treatment of CoA in small patients.
Methods
A single-center retrospective review of all patients ≤20 kg who underwent percutaneous adult sized SI for native or recurrent CoA from 2004 to 2015 was performed.
Results
Thirty-nine patients (20 patients ≤10 kg) were identified, with 28 (71.8%) having recurrent CoA and 22 (56.4%) previously failed balloon angioplasty. At the time of SI, the median (range) patient age and weight were 1.1 (0.3-7.9) years and 10 (5.5-20.4) kg, respectively. SI resulted in significant improvements in the median gradient (26 mm Hg [interquartile range (IQR), 18-42] to 0 mm Hg [IQR, 0-2]; P< 0.05) and median minimum diameter (3.6 mm [IQR, 2.4-4.8] to 7.7 mm [IQR, 6.5-9.4]; P<0.05). Seven patients (18%) had procedural adverse events. Twenty-seven (69%) patients underwent elective reintervention at a median time of 49.3 (IQR, 26.5-63.2) months from SI, with 8 (21%) stents requiring repeat SI for stent fracture. Over a median follow-up of 67.2 (IQR, 33.8-116.1) months, 25 patients (69%) were without hypertension or blood pressure gradient. Three (11%) patients developed femoral arterial occlusion.
Conclusions
Adult sized SI is an alternative to surgical intervention for small patients with CoA. SI carries a risk of access-related complications, which may improve with the development of lower profile stents with adult sized maximum diameters.



Circ Cardiovasc Interv: 30 Jan 2021; 14:e009399
Boe BA, Armstrong AK, Janse SA, Loccoh EC, ... Cheatham JP, Berman DP
Circ Cardiovasc Interv: 30 Jan 2021; 14:e009399 | PMID: 33544625
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Abstract

Relative Impact of Clinical Risk Versus Procedural Risk on Clinical Outcomes After Percutaneous Coronary Intervention.

Kang J, Park KW, Lee HS, Zheng C, ... Koo BK, Kim HS
Background
The clinical outcome after percutaneous coronary intervention (PCI) is affected by various clinical and procedural risk factors. We investigated the relative impact of clinical and procedural risks on clinical outcomes after PCI.
Methods
A total of 13 172 patients were enrolled from the Grand-DES registry. The population was grouped into tertiles (high-, intermediate-, low-risk) according to the number of prespecified clinical and procedural risk factors, respectively. The primary end point was major adverse cardiac and cerebrovascular events (MACCE) at 3 years post-PCI.
Results
MACCE occurred in 1109 (8.4%) patients during the follow-up period (median duration: 1126 days). Compared with procedural risk, clinical risk showed superior predictive power (area under the curve: 0.678 versus 0.570, P<0.001, for clinical and procedural risks, respectively) and greater magnitude of effect in the multivariate analysis for MACCE (Clinical risk: hazard ratio, 1.953 [95% CI, 1.809-2.109], P<0.001; procedural risk: hazard ratio, 1.240 [95% CI, 1.154-1.331], P<0.001). In subgroup analyses within each clinical risk tertile, procedural risk had no significant impact on MACCE in the lowest clinical risk tertile. An annual landmark analysis revealed that clinical and procedural risks were both significant predictors of MACCE, which occurred within the first and second year post-PCI. However, for MACCE occurring in the third year post-PCI, only clinical risk but not procedural risk was a significant predictor of events.
Conclusions
Clinical and procedural risks were both significant predictors for ischemic clinical events in patients undergoing PCI. However, clinical risk had a greater and more prolonged effect on outcomes than procedural risk. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03507205.



Circ Cardiovasc Interv: 30 Jan 2021; 14:e009642
Kang J, Park KW, Lee HS, Zheng C, ... Koo BK, Kim HS
Circ Cardiovasc Interv: 30 Jan 2021; 14:e009642 | PMID: 33541106
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Abstract

Accuracy of Intravascular Ultrasound-Based Fractional Flow Reserve in Identifying Hemodynamic Significance of Coronary Stenosis.

Yu W, Tanigaki T, Ding D, Wu P, ... Wijns W, Tu S
Background
Ultrasonic flow ratio (UFR) is a novel method for fast computation of fractional flow reserve (FFR) from intravascular ultrasound images. The objective of this study is to evaluate the diagnostic performance of UFR using wire-based FFR as the reference.
Methods
Post hoc computation of UFR was performed in consecutive patients with both intravascular ultrasound and FFR measurement in a core lab while the analysts were blinded to FFR.
Results
A total of 167 paired comparisons between UFR and FFR from 94 patients were obtained. Median FFR was 0.80 (interquartile range, 0.68-0.89) and 50.3% had a FFR≤0.80. Median UFR was 0.81 (interquartile range, 0.69-0.91), and UFR showed strong correlation with FFR (r=0.87; P<0.001). The area under the curve was higher for UFR than intravascular ultrasound-derived minimal lumen area (0.97 versus 0.89, P<0.001). The diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio for UFR to identify FFR≤0.80 was 92% (95% CI, 87-96), 91% (95% CI, 82-96), 96% (95% CI, 90-99), 96% (95% CI, 89-99), 91% (95% CI, 93-96), 25.0 (95% CI, 8.2-76.2), and 0.10 (95% CI, 0.05-0.20), respectively. The agreement between UFR and FFR was independent of lesion locations (P=0.48), prior myocardial infarction (P=0.29), and imaging catheters (P=0.22). Intraobserver and interobserver variability of UFR analysis was 0.00±0.03 and 0.01±0.03, respectively. Median UFR analysis time was 102 (interquartile range, 87-122) seconds.
Conclusions
UFR had a strong correlation and good agreement with FFR. The fast computational time and excellent analysis reproducibility of UFR bears the potential of a wider adoption of integration of coronary imaging and physiology in the catheterization laboratory.



Circ Cardiovasc Interv: 30 Jan 2021; 14:e009840
Yu W, Tanigaki T, Ding D, Wu P, ... Wijns W, Tu S
Circ Cardiovasc Interv: 30 Jan 2021; 14:e009840 | PMID: 33541105
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Abstract

Short-Term Outcomes of Transcatheter Versus Isolated Surgical Aortic Valve Replacement for Mediastinal Radiation-Associated Severe Aortic Stenosis.

Nauffal V, Bay C, Shah PB, Sobieszczyk PS, ... O\'Gara P, Nohria A
Background
Surgical aortic valve replacement (SAVR) is associated with adverse outcomes in patients with radiation-associated aortic stenosis. Transcatheter aortic valve replacement (TAVR) may improve outcomes in this population.
Methods
We evaluated 1668 TAVR and 2611 patients with SAVR enrolled in the Society of Thoracic Surgeons\' database between 2011 and 2018. Multiple logistic regression was used to compare 30- day outcomes between TAVR and SAVR. Propensity-matched analysis was performed to confirm results of the overall cohort. Additionally, the cohort was stratified into early (2011-2014) versus contemporary (2015-2018) TAVR eras, and 30-day outcomes for TAVR and SAVR were compared. Finally, outcomes with transfemoral TAVR versus SAVR were compared.
Results
In the overall cohort, TAVR was associated with significantly reduced 30-day mortality (odds ratio [OR]TAVR/SAVR=0.60 [0.40-0.91]). Postoperative atrial fibrillation, pneumonia, pleural effusion, renal failure, and bleeding also occurred less frequently with TAVR. Stroke/transient ischemic attack (TIA; ORTAVR/SAVR, 2.03 [1.09-3.77]) and pacemaker implantation (ORTAVR/SAVR, 1.62 [1.21-2.17]) were higher with TAVR. Propensity-matched analysis yielded similar results as the overall cohort. Following stratification by era, TAVR versus SAVR was associated with reduced 30-day mortality in the contemporary but not early era (OREarly, 0.78 [0.48-1.28]; ORContemporary, 0.31 [0.14-0.65]). Pacemaker implantation was higher with TAVR versus SAVR in both eras (OREarly, 1.60 [1.03-2.46]; ORContemporary, 1.64 [1.10-2.45]). There was also a nonsignificant trend towards increased stroke/TIA with TAVR during both eras (OREarly, 1.39 [0.58-3.36]; ORContemporary, 2.46 [0.99-6.10]). Finally, transfemoral TAVR (N=1369) versus SAVR revealed similar findings as the overall cohort; however, the association of TAVR with stroke/TIA was not statistically significant (ORStroke/TIA, 1.57 [0.79-3.09]).
Conclusions
TAVR provides an effective and evolving alternative to SAVR for radiation-associated severe aortic stenosis and was associated with lower 30-day mortality and postoperative complications. TAVR was associated with increased pacemaker implantation and a trend towards increased stroke/TIA. In this unique population with extensive valvular and vascular calcifications, the risk of stroke/TIA with TAVR requires careful consideration and further investigation.



Circ Cardiovasc Interv: 30 Jan 2021; 14:e010009
Nauffal V, Bay C, Shah PB, Sobieszczyk PS, ... O'Gara P, Nohria A
Circ Cardiovasc Interv: 30 Jan 2021; 14:e010009 | PMID: 33541102
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Abstract

Patient Selection and Clinical Outcomes in the STOPDAPT-2 Trial: An All-Comer Single-Center Registry During the Enrollment Period of the STOPDAPT-2 Randomized Controlled Trial.

Kanenawa K, Yamaji K, Tashiro H, Domei T, ... Watanabe H, Kimura T
Background
We sought to evaluate the impact of patient selection for the STOPDAPT-2 trial (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2) on clinical outcomes in a registry from a single center that participated in the STOPDAPT-2 trial.
Methods
Among 2190 consecutive patients who underwent percutaneous coronary intervention using stent in Kokura Memorial Hospital during the enrollment period of the STOPDAPT-2 trial, 521 patients had exclusion criteria such as in-hospital major complications, anticoagulant use, or prior intracranial bleeding (ineligible group). Among 1669 patients who met the eligibility criteria (eligible group), 582 were enrolled (enrolled group) and 1087 were not enrolled (nonenrolled group) in the STOPDAPT-2 trial. The primary outcome measure was defined as a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, stroke, or Thrombolysis in Myocardial Infarction major and minor bleeding.
Results
Compared with the enrolled group, patients in the nonenrolled group more often had high bleeding risk according to the Academic Research Consortium for High Bleeding Risk definition (52.6% versus 41.2%; P<0.001) and were frailer according to the Canadian Study of Health and Aging Clinical Frailty Scale (intermediate, 21.4% versus 14.1%; high, 6.4% versus 2.1%; P<0.001). The cumulative 1-year incidences of the primary outcome measure, all-cause death, and major bleeding were significantly higher in the nonenrolled group than in the enrolled group (7.2% versus 4.5%, P=0.03; 4.1% versus 0.9%, P<0.001; and 4.3% versus 2.1%, P=0.03, respectively) and in the ineligible group than in the eligible group (21.2% versus 6.3%, P<0.001; 9.9% versus 3.0%, P<0.001; and 13.5% versus 3.5%, P<0.001, respectively).
Conclusions
Patients who were ineligible, eligible but not enrolled, and enrolled in the STOPDAPT-2 trial had different risk profiles and clinical outcomes, suggesting important implications in applying the trial results in daily clinical practice.



Circ Cardiovasc Interv: 30 Jan 2021; 14:e010007
Kanenawa K, Yamaji K, Tashiro H, Domei T, ... Watanabe H, Kimura T
Circ Cardiovasc Interv: 30 Jan 2021; 14:e010007 | PMID: 33541100
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Abstract

Prognostic Impact of Change in Nutritional Risk on Mortality and Heart Failure After Transcatheter Aortic Valve Replacement.

González Ferreiro R, López Otero D, Álvarez Rodríguez L, Otero García Ó, ... Cruz-González I, González Juanatey JR
Background
Limited data are available regarding change in the nutritional status after transcatheter aortic valve replacement (TAVR). This study evaluated the prognostic impact of the change in the geriatric nutritional risk index following TAVR.
Methods
TAVR patients were analyzed in a prospective and observational study. To analyze the change in nutritional status, geriatric nutritional risk index of the patients was calculated on the day of TAVR and at 3-month follow-up. The impact of the change in nutritional risk index after TAVR on all-cause mortality, heart failure hospitalization (HF-h), and the composite of all-cause death and HF hospitalization was analyzed using the Cox Proportional Hazards model.
Results
Four hundred thirty-three patients were included. After TAVR, 68.4% (n=182) patients with baseline nutritional risk improved compared with 31.6% (n=84) who remained at nutritional risk. The change from no-nutritional risk to nutritional risk after TAVR occurred in 15.0% (n=25), while 85.0% (n=142) remained without risk of malnutrition. During follow-up, 157 (36.3%) patients died and 172 patients (39.7%) were hospitalized due to HF. Patients who continued to be at nutritional risk had a higher risk of mortality (hazard ratio [HR], 2.10 [95% CI, 1.30-3.39], P=0.002), HF-h (HR, 1.97 [95% CI, 1.26-3.06], P=0.000), and the composite of death and HF-h (HR, 2.0 [95% CI, 1.37-2.91], P<0.001). The change to non-nutritional risk after TAVR significantly impacted mortality (HR, 0.48 [95% CI, 0.30-0.78], P=0.003), HF-h (HR, 0.50 [95% CI, 0.34-0.74], P=0.001), and the composite outcome (HR, 0.44 [95% CI, 0.32-0.62], P<0.001).
Conclusions
Remaining at nutritional risk after TAVR confers a poor prognosis and is associated with an increased risk of mortality and HF-h, while the change from risk of malnutrition to non-nutritional risk after TAVR was associated with a halving of the risk of mortality and HF-h. Further studies are needed to identify whether patients at nutritional risk would benefit from nutritional intervention during processes of care of TAVR programs.



Circ Cardiovasc Interv: 30 Jan 2021; 14:e009342
González Ferreiro R, López Otero D, Álvarez Rodríguez L, Otero García Ó, ... Cruz-González I, González Juanatey JR
Circ Cardiovasc Interv: 30 Jan 2021; 14:e009342 | PMID: 33541099
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Abstract

Therapeutic Approaches for the No-Option Refractory Angina Patient.

Povsic TJ, Henry TD, Ohman EM
The combination of an aging population and improved survival rates among patients with coronary artery disease has resulted in an increase in the number of patients with refractory angina or anginal equivalent symptoms despite maximal medical therapy. Patients with refractory angina are often referred to the cardiac catheterization laboratory; however, they have often exhausted conventional revascularization options; thus, this population is often deemed as having \"no options.\" We review the definition, prevalence, outcomes, therapeutic options, and treatment considerations for no-option refractory angina patients and focus on novel therapies for this complex and challenging population. We propose a multidisciplinary team approach for the evaluation and management of patients with refractory angina, ideally in a designated clinic. The severe limitations and symptomatology experienced by these patients highlight the need for additional research into the development of innovative treatments.



Circ Cardiovasc Interv: 30 Jan 2021; 14:e009002
Povsic TJ, Henry TD, Ohman EM
Circ Cardiovasc Interv: 30 Jan 2021; 14:e009002 | PMID: 33541098
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Abstract

Transcatheter Tricuspid Valve Intervention in Patients With Right Ventricular Dysfunction or Pulmonary Hypertension: Insights From the TriValve Registry.

Muntané-Carol G, Taramasso M, Miura M, Gavazzoni M, ... Hahn RT, Rodés-Cabau J
Background
Scarce data exist on patients with right ventricular dysfunction (RVD) or pulmonary hypertension (PH) undergoing transcatheter tricuspid valve intervention. This study aimed to determine the early and midterm outcomes and the factors associated with mortality in this group of patients.
Methods
This subanalysis of the multicenter TriValve (Transcatheter Tricuspid Valve Therapies) registry included 300 patients with severe tricuspid regurgitation with RVD (n=244), PH (n=127), or both (n=71) undergoing transcatheter tricuspid valve intervention. RVD was defined as a tricuspid annular plane systolic excursion <17 mm, and PH as an estimated pulmonary artery systolic pressure ≥50 mm Hg.
Results
Mean age of the patients was 77±9 years (54% women). Procedural success was 80.7%, and 9 patients (3%) died during the hospitalization. At a median follow-up of 6 (interquartile range, 2-12) months, 54 patients (18%) died, and the independent associated factors were higher gamma-glutamyl transferase values at baseline (hazard ratio, 1.02 for each increase of 10 u/L [95% CI, 1.002-1.04]), poorer renal function defined as an estimated glomerular filtration rate <45 mL/min (hazard ratio, 2.3 [95% CI, 1.22-4.33]), and the lack of procedural success (hazard ratio, 2.11 [95% CI, 1.17-3.81]). The grade of RVD and the amount of PH at baseline were not found to be predictors of mortality. Most patients alive at follow-up improved their functional class (New York Heart Association I-II in 66% versus 7% at baseline, P<0.001).
Conclusions
In patients with severe tricuspid regurgitation and RVD/PH, transcatheter tricuspid valve intervention was associated with high procedural success and a relatively low in-hospital mortality, along with significant improvements in functional status. However, about 1 out of 5 patients died after a median follow-up of 6 months, with hepatic congestion, renal dysfunction, and the lack of procedural success determining an increased risk. These results may improve the clinical evaluation of transcatheter tricuspid valve intervention candidates and would suggest a closer follow-up in those at increased risk. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03416166.



Circ Cardiovasc Interv: 30 Jan 2021; 14:e009685
Muntané-Carol G, Taramasso M, Miura M, Gavazzoni M, ... Hahn RT, Rodés-Cabau J
Circ Cardiovasc Interv: 30 Jan 2021; 14:e009685 | PMID: 33541097
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Abstract

Risk Stratification Guided by the Index of Microcirculatory Resistance and Left Ventricular End-Diastolic Pressure in Acute Myocardial Infarction.

Maznyczka AM, McCartney PJ, Oldroyd KG, Lindsay M, ... McConnachie A, Berry C
Background
The index of microcirculatory resistance (IMR) of the infarct-related artery and left ventricular end-diastolic pressure (LVEDP) are acute, prognostic biomarkers in patients undergoing primary percutaneous coronary intervention. The clinical significance of IMR and LVEDP in combination is unknown.
Methods
IMR and LVEDP were prospectively measured in a prespecified substudy of the T-TIME clinical trial (Trial of Low Dose Adjunctive Alteplase During Primary PCI). IMR was measured using a pressure- and temperature-sensing guidewire following percutaneous coronary intervention. Prognostically established thresholds for IMR (>32) and LVEDP (>18 mm Hg) were predefined. Contrast-enhanced cardiovascular magnetic resonance imaging (1.5 Tesla) was acquired 2 to 7 days and 3 months postmyocardial infarction. The primary end point was major adverse cardiac events, defined as cardiac death/nonfatal myocardial infarction/heart failure hospitalization at 1 year.
Results
IMR and LVEDP were both measured in 131 patients (mean age 59±10.7 years, 103 [78.6%] male, 48 [36.6%] with anterior myocardial infarction). The median IMR was 29 (interquartile range, 17-55), the median LVEDP was 17 mm Hg (interquartile range, 12-21), and the correlation between them was not statistically significant (r=0.15; P=0.087). Fifty-three patients (40%) had low IMR (≤32) and low LVEDP (≤18), 18 (14%) had low IMR and high LVEDP, 31 (24%) had high IMR and low LVEDP, while 29 (22%) had high IMR and high LVEDP. Infarct size (% LV mass), LV ejection fraction, final myocardial perfusion grade ≤1, TIMI (Thrombolysis In Myocardial Infarction) flow grade ≤2, and coronary flow reserve were associated with LVEDP/IMR group, as was hospitalization for heart failure (n=18 events; P=0.045) and major adverse cardiac events (n=21 events; P=0.051). LVEDP>18 and IMR>32 combined was associated with major adverse cardiac events, independent of age, estimated glomerular filtration rate, and infarct-related artery (odds ratio, 5.80 [95% CI, 1.60-21.22] P=0.008). The net reclassification improvement for detecting major adverse cardiac events was 50.6% (95% CI, 2.7-98.2; P=0.033) when LVEDP>18 was added to IMR>32.
Conclusions
IMR and LVEDP in combination have incremental value for risk stratification following primary percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02257294.



Circ Cardiovasc Interv: 30 Jan 2021; 14:e009529
Maznyczka AM, McCartney PJ, Oldroyd KG, Lindsay M, ... McConnachie A, Berry C
Circ Cardiovasc Interv: 30 Jan 2021; 14:e009529 | PMID: 33591821
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This program is still in alpha version.