Journal: Circ Cardiovasc Interv

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Abstract

Calcium Modification Techniques in Complex Percutaneous Coronary Intervention.

Shah M, Najam O, Bhindi R, De Silva K

Percutaneous coronary intervention is the most common mode of revascularization and is increasingly undertaken in high-risk subsets, including the elderly. The presence of coronary artery calcification is increasingly observed and significantly limits technical success. The mechanisms for this are multi-factorial, including increased arterial wall stiffness and impaired delivery of devices, leading to suboptimal stent delivery, deployment, and expansion which are harbingers for increased risk of in-stent restenosis and stent thrombosis. Although conventional balloon pretreatment techniques aim to mitigate this risk by modifying the lesion before stent placement, many lesions remain resistant to conventional strategies, due to the severity of calcification. There have been several substantial technological advancements in calcium modification methods in recent years, which have allowed improved procedural success with low periprocedural complication rates. This review will summarize the current adjunctive modification technologies that can be employed to improve technical outcomes in percutaneous coronary intervention in calcific disease and the evidence supporting these tools.



Circ Cardiovasc Interv: 13 Jan 2021:CIRCINTERVENTIONS120009870; epub ahead of print
Shah M, Najam O, Bhindi R, De Silva K
Circ Cardiovasc Interv: 13 Jan 2021:CIRCINTERVENTIONS120009870; epub ahead of print | PMID: 33441017
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Abstract

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

Redfors B, Mohebi R, Giustino G, Chen S, ... Ben-Yehuda O, Stone GW

: 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. : Individual patient data for 3115 STEMI patients undergoing pPCI in 10 randomized trials were pooled. Infarct size (% left ventricular mass) was assessed within 1 month after randomization by technetium-99m sestamibi single-photon emission computerized tomography (SPECT, 3 studies) or cardiac magnetic resonance imaging (CMR, 7 studies). MVO was assessed by CMR. Patients were stratified by short (≤2 hours), intermediate (2-4 hours), or long (>4 hours) SBTs, and by short (≤45 minutes), intermediate (45-90 min), or long (>90 minutes) DBTs. : Median [IQR] SBT and DBT were 185 [130-269] and 46 [28-83] minutes, respectively. Median [IQR] 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% confidence interval [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 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. : Among 3115 patients with STEMI undergoing infarct size assessment after pPCI, SBT was more strongly correlated with infarct size and MVO than DBT.



Circ Cardiovasc Interv: 13 Jan 2021; epub ahead of print
Redfors B, Mohebi R, Giustino G, Chen S, ... Ben-Yehuda O, Stone GW
Circ Cardiovasc Interv: 13 Jan 2021; epub ahead of print | PMID: 33440999
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Abstract

Sex Differences in Ischemic and Bleeding Outcomes in Patients With Non-ST-Segment-Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Insights From the TAO Trial.

Dillinger JG, Ducrocq G, Elbez Y, Cohen M, ... Mehta SR, Steg PG
Background
Previous studies have observed poorer outcomes in females with myocardial infarction, but older age and lower use of percutaneous coronary intervention in females are factors that potentially explain the worse outcome. This study sought to determine if female sex is an independent factor of ischemic and bleeding outcomes in non-ST-segment-elevation acute coronary syndrome treated with a systematic invasive approach.
Methods
The TAO trial (Treatment of Acute Coronary Syndrome With Otamixaban) randomized patients with non-ST-segment-elevation acute coronary syndrome treated invasively to heparin plus eptifibatide versus otamixaban. In this post hoc analysis, the primary ischemic end point (all-cause death, myocardial infarction within 180 days) and the primary safety end point (Thrombolysis in Myocardial Infarction major or minor bleeding within 30 days) were analyzed according to sex.
Results
Of 13 229 randomized patients, 3980 (30.1%) were females and 9249 (69.9%) were males. Females were older (64.8±11.0 versus 60.7±11.1 years), had more comorbidities, received less peri-procedural antithrombotic therapy, and underwent less frequently revascularization. Overall, females experienced a higher risk of ischemic (10.2% versus 9.1%; odds ratio [OR], 1.15 [1.01-1.30]) and bleeding events (4.2% versus 3.4%; OR, 1.23 [1.02-1.49]) than males. After multivariate analysis, the risk of ischemic outcomes (OR, 1.04 [0.90-1.19]), death (OR, 1.00 [0.75-1.23]), or bleeding (OR, 1.05 [0.85-1.28]), were similar between females and males. Only, noncoronary artery bypass graft related Thrombolysis in Myocardial Infarction major bleeding were increased in females (OR, 1.69 [1.11-2.56]).
Conclusions
In patients with non-ST-segment-elevation acute coronary syndrome with systematic invasive management, ischemic outcomes, bleeding events, and mortality were higher in females. After multivariate analyses, female sex was not an independent predictor of ischemic and bleeding events although noncoronary artery bypass graft related Thrombolysis in Myocardial Infarction major bleeding was higher in females.
Registration
URL: https://www.clinicaltrials.gov. Unique identifier: NCT01076764.



Circ Cardiovasc Interv: 11 Jan 2021:CIRCINTERVENTIONS120009759; epub ahead of print
Dillinger JG, Ducrocq G, Elbez Y, Cohen M, ... Mehta SR, Steg PG
Circ Cardiovasc Interv: 11 Jan 2021:CIRCINTERVENTIONS120009759; epub ahead of print | PMID: 33430604
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Abstract

Systematic Approach to High Implantation of SAPIEN-3 Valve Achieves a Lower Rate of Conduction Abnormalities Including Pacemaker Implantation.

Sammour Y, Banerjee K, Kumar A, Lak H, ... Krishnaswamy A, Kapadia S
Background
The conventional method of implanting balloon-expandable SAPIEN-3 (S3) valve results in a final 70:30 or 80:20 ratio of the valve in the aorta:left ventricular outflow tract with published rates of permanent pacemaker around 10%. We sought to evaluate whether higher implantation of S3 reduces conduction abnormalities including the need for permanent pacemaker.
Methods
We included consecutive patients who underwent transfemoral transcatheter aortic valve replacement using S3 between April 2015 and December 2018 and compared outcomes with typical valve deployment strategy to our more contemporary high deployment technique (HDT). We excluded patients with nontransfemoral access or valve-in-valve.
Results
Among 1028 patients, HDT was performed in 406 patients (39.5%). Mean implantation depth under the noncoronary cusp was significantly smaller with HDT compared with conventional technique (1.5±1.6 versus 3.2±1.9 mm; <0.001). Successful implantation was achieved in 100% of the patients in both groups with no cases of conversion to open heart surgery, second valve implantation within the first transcatheter aortic valve replacement, or coronary occlusion during transcatheter aortic valve replacement. One patient (0.2%) had valve embolization with HDT (=0.216). Thirty-day permanent pacemaker rates were lower with HDT (5.5% versus 13.1%; <0.001), as were rates of complete heart block (3.5% versus 11.2%; <0.001) and new-onset left bundle branch block (5.3% versus 12.2%; <0.001). There were no differences in mild (16.5% versus 15.9%; =0.804), or moderate-to-severe aortic regurgitation (1% versus 2.7%; =0.081) at 1 year. HDT was associated with slightly higher 1-year mean gradients (13.1±6.2 versus 11.8±4.9 mm Hg; =0.042) and peak gradients (25±11.9 versus 22.5±9 mm Hg; =0.026). However, Doppler velocity index was similar (0.47±0.15 versus 0.48±0.13; =0.772).
Conclusions
Our novel technique for balloon-expandable S3 valve positioning consistently achieves higher implantation resulting in substantial reduction in conduction abnormalities and permanent pacemaker requirement after transcatheter aortic valve replacement without compromising procedural safety or valve hemodynamics. Operators should consider this as an important technique to improve patient outcomes.



Circ Cardiovasc Interv: 11 Jan 2021:CIRCINTERVENTIONS120009407; epub ahead of print
Sammour Y, Banerjee K, Kumar A, Lak H, ... Krishnaswamy A, Kapadia S
Circ Cardiovasc Interv: 11 Jan 2021:CIRCINTERVENTIONS120009407; epub ahead of print | PMID: 33430603
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Abstract

Heart Team/Guidelines Discordance Is Associated With Increased Mortality: Data From a National Survey of Revascularization in Patients With Complex Coronary Artery Disease.

Witberg G, Segev A, Barac YD, Raanani E, ... Goldenberg I, Kornowski R
Background
Practice guidelines emphasize the role of the SYNTAX score (SS; Synergy Between PCI With TAXUS and Cardiac Surgery) in choosing between percutaneous coronary intervention and coronary artery bypass graft surgery in cases of complex coronary artery disease. There is paucity of data on the implementation of these recommendations in daily practice, and on the consequences of guideline discordant revascularization.
Methods
This was a retrospective analysis of a prospective national survey of consecutive real world patients undergoing coronary revascularization for complex coronary artery disease according to decisions of local heart team at each center. SS was calculated at a dedicated CoreLab, and patients were classified as heart team/guidelines agreement/discordant.
Results
Nine hundred seventy-nine patients (571 percutaneous coronary intervention and 408 coronary artery bypass graft) were included. Mean age was 65 years and the mean SS was 22. Heart team/guidelines discordance occurred in 170 (17.3%) patients. Independent predictors of heart team/guidelines discordance were age, admission to a center with no cardiac surgery service, SS, and previous percutaneous coronary intervention/myocardial infarction. A multivariate model based on these characteristics had a C statistic of 0.83. Thirty-day outcomes were similar in the agreement/discordance groups, however, heart team/guidelines discordance was associated with a significant increase in 3 year mortality (17.6% versus 8.4%; hazard ratio, 2.05; =0.002) after multivariate adjustment.
Conclusions
Heart team/guidelines discordance is not infrequent in real world patients with complex coronary artery disease undergoing revascularization. This is more likely to occur in elderly patients, those with more complex coronary disease (as determined by the SS), and those treated at centers with no cardiac surgery service. These patients have a higher risk for mid-term mortality.



Circ Cardiovasc Interv: 10 Jan 2021:CIRCINTERVENTIONS120009686; epub ahead of print
Witberg G, Segev A, Barac YD, Raanani E, ... Goldenberg I, Kornowski R
Circ Cardiovasc Interv: 10 Jan 2021:CIRCINTERVENTIONS120009686; epub ahead of print | PMID: 33423541
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Abstract

Randomized Trial of Aspirin Versus Warfarin After Transcatheter Aortic Valve Replacement in Low-Risk Patients.

Rogers T, Shults C, Torguson R, Shea C, ... Satler LF, Waksman R
Background
The optimal antithrombotic regimen after transcatheter aortic valve replacement remains unclear.
Methods
In this randomized open-label study, low-risk patients undergoing transfemoral transcatheter aortic valve replacement at 7 centers in the United States were randomized 1:1 to low-dose aspirin or warfarin plus low-dose aspirin for 30 days. Patients who could not be randomized were enrolled in a separate registry. Computed tomography or transesophageal echocardiography was performed at 30 days. The primary effectiveness end point was a composite of the following at 30 days: hypoattenuated leaflet thickening, at least moderately reduced leaflet motion, hemodynamic dysfunction (mean aortic valve gradient ≥20 mm Hg, effective orifice area ≤1.0 cm, dimensionless valve index <0.35, or moderate or severe aortic regurgitation), stroke, or transient ischemic attack.
Results
Between July 2018 and October 2019, 94 patients were randomly assigned, 50 to aspirin and 44 to warfarin plus aspirin, and 30 were enrolled into the registry. In the intention-to-treat analysis of the randomized cohort, the composite primary effectiveness end point was met in 26.5% for aspirin versus 7.0% for warfarin plus aspirin (=0.014; odds ratio, 4.8 [95% CI, 1.3-18.3]). The rate of hypoattenuated leaflet thickening was 16.3% for aspirin versus 4.7% for warfarin plus aspirin (=0.07; odds ratio, 4.0 [95% CI, 0.8-20.0]). There was no excess bleeding at 30 days with anticoagulation. In the as-treated analysis of pooled randomized and registry cohorts, the rate of hypoattenuated leaflet thickening was 16.7% for aspirin versus 3.1% for warfarin plus aspirin (=0.011; odds ratio, 6.3 [95% CI, 1.3-30.6]).
Conclusions
In low-risk transcatheter aortic valve replacement patients, anticoagulation with warfarin may prevent transcatheter heart valve dysfunction in the short term without excess bleeding. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03557242.



Circ Cardiovasc Interv: 10 Jan 2021:CIRCINTERVENTIONS120009983; epub ahead of print
Rogers T, Shults C, Torguson R, Shea C, ... Satler LF, Waksman R
Circ Cardiovasc Interv: 10 Jan 2021:CIRCINTERVENTIONS120009983; epub ahead of print | PMID: 33423540
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Abstract

Safety and Feasibility of Same-Day Discharge After Left Atrial Appendage Closure With the WATCHMAN Device.

Tan BE, Boppana LKT, Abdullah AS, Chuprun D, ... Bhatt DL, Depta JP
Background
As the use of left atrial appendage closure (LAAC) becomes more widespread, improvements in resource utilization and cost-effectiveness are necessary. Currently, there are limited data on same-day discharge (SDD) after LAAC. We aimed to evaluate the safety and feasibility of SDD versus non-SDD in patients with nonvalvular atrial fibrillation who underwent LAAC.
Methods
We retrospectively studied 211 patients who underwent the WATCHMAN procedure in a tertiary hospital (June 2016 to June 2019). The primary safety outcome was the composite of stroke, systemic embolism, major bleeding requiring transfusion, vascular complications requiring endovascular intervention, or death through 7 days (periprocedural) and 45 days post-procedure. The secondary outcomes were the individual components of the primary outcome and all-cause readmission. We compared the clinical outcomes of patients who had SDD and non-SDD post-procedure.
Results
Patients with procedure-related complications on the day of LAAC and patients who were admitted for acute clinical events before LAAC were excluded. One hundred ninety patients were included in the final analysis. Seventy-two of 190 (38%) patients had SDD, and 118 of 190 (62%) had non-SDD. There were no statistically significant differences in the primary safety outcome through 7 days (1.4% versus 5.9%; =0.26) and 45 days post-procedure (2.8% versus 9.3%; =0.14) between the two groups. The secondary outcomes were similar in both groups. No patients had device-related thrombus on transesophageal echocardiography at 45 days. Only 1 patient from the non-SDD group had clinically significant peri-device flow (>5 mm) at 45 days.
Conclusions
In a selected cohort of patients who underwent successful elective LAAC with WATCHMAN without same-day procedure-related complications, the primary safety outcome and secondary outcomes through 7 and 45 days post-procedure were similar in the SDD and non-SDD groups. Our findings are hypothesis generating and warrant further investigation in prospective trials.



Circ Cardiovasc Interv: 10 Jan 2021:CIRCINTERVENTIONS120009669; epub ahead of print
Tan BE, Boppana LKT, Abdullah AS, Chuprun D, ... Bhatt DL, Depta JP
Circ Cardiovasc Interv: 10 Jan 2021:CIRCINTERVENTIONS120009669; epub ahead of print | PMID: 33423538
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Abstract

First-in-Human Study to Assess the Safety and Feasibility of the Bashir Endovascular Catheter for the Treatment of Acute Intermediate-Risk Pulmonary Embolism.

Sista AK, Bhatheja R, Rali P, Natarajan K, ... Bashir R, Rosenfield K
Background
The Bashir Endovascular Catheter (BEC) is a novel pharmaco-mechanical device designed to enhance thrombolysis by increasing the exposure of thrombus to endogenous and exogenous thrombolytics. The aim of this prospective, multicenter, single-arm study was to evaluate the feasibility and initial safety of the BEC in patients with acute intermediate-risk pulmonary embolism (PE).
Methods
Patients with symptomatic PE and right ventricular to left ventricular diameter ratio ≥0.9 as documented by computer tomography angiography were eligible for enrollment. The primary safety end points were device related death or adverse events, and major bleeding within 72 hours after BEC directed therapy.
Results
Nine patients were enrolled across 4 US sites. The total dose of r-tPA (recombinant tissue-type plasminogen activator) was 14 mgs in bilateral PE and 12 mgs in unilateral PE over 8 hours delivered via the expanded BEC. At 30-day follow-up, there were no deaths or device-related adverse events. At 48 hours post-BEC therapy, the right ventricular to left ventricular diameter ratio decreased from 1.52±0.26 to 0.97±0.06 (=0.0009 [95% CI, 0.33-0.82]; 37.0% reduction). Thrombus burden as measured by the Modified Miller Index decreased from 25.4±5.3 to 16.0±4.0 (=0.0005; [95% CI, 5.5-13.4]; 37.1% reduction).
Conclusions
In this early feasibility study of the BEC for intermediate-risk PE, there were no deaths or device-related adverse events and a significant reduction in right ventricular to left ventricular diameter ratio and thrombus burden.
Registration
URL: https://www.clinicaltrials.gov. Unique identifier: NCT03927508.



Circ Cardiovasc Interv: 23 Dec 2020:CIRCINTERVENTIONS120009611; epub ahead of print
Sista AK, Bhatheja R, Rali P, Natarajan K, ... Bashir R, Rosenfield K
Circ Cardiovasc Interv: 23 Dec 2020:CIRCINTERVENTIONS120009611; epub ahead of print | PMID: 33356383
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Abstract

Clinical and Anatomic Complexity of Patients Undergoing Coronary Intervention With and Without On-Site Surgical Capabilities: Insights From the Veterans Affairs Clinical Assessment, Reporting and Tracking (CART) Program.

Waldo SW, Hebbe A, Grunwald GK, Doll JA, Schofield R
Background
Professional society consensus statements articulate the clinical and anatomic complexity of patients that may undergo percutaneous coronary intervention (PCI) without on-site cardiothoracic surgery, although compliance with these recommendations has not been assessed. We sought to evaluate the clinical and anatomic complexity of patients undergoing PCI with and without cardiothoracic surgery on-site.
Methods
We identified all patients undergoing PCI in the Veterans Affairs health care system between October 2009 and September 2017. The clinical and anatomic complexity of patients treated at sites with or without cardiothoracic surgery was evaluated with a comparative interrupted time series, and mortality was ascertained in a propensity-matched cohort.
Results
We identified 75 564 patients who underwent PCI, with the majority (53 708, 71%) treated at sites with cardiothoracic surgery. The overall clinical complexity was statistically greater for those treated at sites with cardiothoracic surgery (National Cardiovascular Data Registries CathPCI: 18.4) compared with those at sites without (17.8, <0.001) throughout the study, with similar annual increases in complexity before (2% versus 3%; =0.107) and after (3% versus 3%; =0.704) January 2014. The anatomic complexity of patients treated was also statistically greater (Veterans Affairs SYNTAX: 11.0 versus 10.2; <0.001) and increased at comparable rates (2% versus 1%, =0.731) before 2014. After publication of the consensus statement, anatomic complexity declined at sites with cardiothoracic surgery (-2%) but increased at sites without on-site surgery (5%, =0.025) such that it was similar at the end of the study (=0.622). Referrals for emergent cardiothoracic surgery were rare regardless of treatment venue (61, 0.08%) and the hazard for mortality was similar (hazard ratio, 0.883 [95% CI, 0.662-1.176]) after propensity matching.
Conclusions
There are minor differences in complexity of patients undergoing coronary intervention at sites with and without cardiothoracic surgery. Clinical outcomes are similar regardless of treatment venue, suggesting an opportunity to improve access to complex interventional care without sacrificing quality.



Circ Cardiovasc Interv: 22 Dec 2020:CIRCINTERVENTIONS120009697; epub ahead of print
Waldo SW, Hebbe A, Grunwald GK, Doll JA, Schofield R
Circ Cardiovasc Interv: 22 Dec 2020:CIRCINTERVENTIONS120009697; epub ahead of print | PMID: 33354988
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Abstract

Percutaneous Axillary Access for Placement of Microaxial Ventricular Support Devices: The Axillary Access Registry to Monitor Safety (ARMS).

McCabe JM, Kaki AA, Pinto DS, Kirtane AJ, ... Kapur NK, Tayal R
Background
There has been increasing utilization of short-term mechanical circulatory support devices for a variety of clinical indications. Many patients have suboptimal iliofemoral access options or reasons why early mobilization is desirable. Axillary artery access is an option for these patients, but little is known about the utility of this approach to facilitate short-term use for circulatory support with microaxial pump devices.
Methods
The Axillary Access Registry to Monitor Safety (ARMS) was a prospective, observational multicenter registry to study the feasibility and acute safety of mechanical circulatory support via percutaneous upper-extremity access.
Results
One hundred and two patients were collected from 10 participating centers. Successful device implantation was 98% (100 of 102). Devices were implanted for a median of 2 days (interquartile range, 0-5 days; range, 0-35 days). Procedural complications included 10 bleeding events and 1 stroke. There were 3 patients with brachial plexus-related symptoms all consisting of C8 tingling and all arising after multiple days of support. Postprocedural access site hematoma or bleeding was noted in 9 patients. Device explantation utilized closure devices alone in 61%, stent grafts in 17%, balloon tamponade facilitated closure in 15%, and planned surgical explant in 5%. Duration of support appeared to be independently associated with a 1.1% increased odds of vascular complication per day ([95% CI, 0.0%-2.3%] =0.05).
Conclusions
Percutaneous axillary access for use with microaxial support pumps appears feasible with acceptable rates of bleeding despite early experience. Larger studies are necessary to confirm the pilot data presented here.



Circ Cardiovasc Interv: 15 Dec 2020:CIRCINTERVENTIONS120009657; epub ahead of print
McCabe JM, Kaki AA, Pinto DS, Kirtane AJ, ... Kapur NK, Tayal R
Circ Cardiovasc Interv: 15 Dec 2020:CIRCINTERVENTIONS120009657; epub ahead of print | PMID: 33322918
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Abstract

Feasibility and Validity of Computed Tomography-Derived Fractional Flow Reserve in Patients With Severe Aortic Stenosis: The CAST-FFR Study.

Michail M, Ihdayhid AR, Comella A, Thakur U, ... Ko BS, Brown AJ
Background
Coronary artery disease is common in patients with severe aortic stenosis. Computed tomography-derived fractional flow reserve (CT-FFR) is a clinically used modality for assessing coronary artery disease, however, its use has not been validated in patients with severe aortic stenosis. This study assesses the safety, feasibility, and validity of CT-FFR in patients with severe aortic stenosis.
Methods
Prospectively recruited patients underwent standard-protocol invasive FFR and coronary CT angiography (CTA). CTA images were analyzed by central core laboratory (HeartFlow, Inc) for independent evaluation of CT-FFR. CT-FFR data were compared with FFR (ischemia defined as FFR ≤0.80).
Results
Forty-two patients (68 vessels) underwent FFR and CTA; 39 patients (92.3%) and 60 vessels (88.2%) had interpretable CTA enabling CT-FFR computation. Mean age was 76.2±6.7 years (71.8% male). No patients incurred complications relating to premedication, CTA, or FFR protocol. Mean FFR and CT-FFR were 0.83±0.10 and 0.77±0.14, respectively. CT calcium score was 1373.3±1392.9 Agatston units. On per vessel analysis, there was positive correlation between FFR and CT-FFR (Pearson correlation coefficient, =0.64, <0.0001). Sensitivity, specificity, positive predictive value, and negative predictive values were 73.9%, 78.4%, 68.0%, and 82.9%, respectively, with 76.7% diagnostic accuracy. The area under the receiver-operating characteristic curve for CT-FFR was 0.83 (0.72-0.93, <0.0001), which was higher than that of CTA and quantitative coronary angiography (=0.01 and <0.001, respectively). Bland-Altman plot showed mean bias between FFR and CT-FFR as 0.059±0.110. On per patient analysis, the sensitivity, specificity, positive predictive, and negative predictive values were 76.5%, 77.3%, 72.2%, and 81.0% with 76.9% diagnostic accuracy. The per patient area under the receiver-operating characteristic curve analysis was 0.81 (0.67-0.95, <0.0001).
Conclusions
CT-FFR is safe and feasible in patients with severe aortic stenosis. Our data suggests that the diagnostic accuracy of CT-FFR in this cohort potentially enables its use in clinical practice and provides the foundation for future research into the use of CT-FFR for coronary evaluation pre-aortic valve replacement.



Circ Cardiovasc Interv: 15 Dec 2020:CIRCINTERVENTIONS120009586; epub ahead of print
Michail M, Ihdayhid AR, Comella A, Thakur U, ... Ko BS, Brown AJ
Circ Cardiovasc Interv: 15 Dec 2020:CIRCINTERVENTIONS120009586; epub ahead of print | PMID: 33322917
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Abstract

Early Adverse Impact of Transfusion After Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the TRITAVI Registry.

Zimarino M, Barbanti M, Dangas GD, Testa L, ... Bedogni F, Tamburino C
Background
There is no consensus on the benefit of red blood cell (RBC) transfusion after transcatheter aortic valve replacement.
Methods
The multicenter Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) registry retrospectively included patients after transfemoral transcatheter aortic valve replacement; propensity score-matching identified pairs of patients with and without RBC transfusion. The primary end point was 30-day mortality; nonfatal myocardial infarction, cerebrovascular accident, and stage 2 to 3 acute kidney injury at 30 days were secondary end points. We repeated propensity score-matching according to the hemoglobin nadir, hemoglobin drop, and in the subgroup of uncomplicated patients, without major vascular complications or major bleeding.
Results
Among 2587 patients, RBC transfusion was administered in 421 cases (16%). The primary end point occurred in 104 (4.0%) patients, myocardial infarction in 9 (0.4%), cerebrovascular accident in 38 (1.5%), and acute kidney injury in 125 (4.8%) cases. In the 842 propensity-matched patients, RBC transfusion was associated with increased mortality (hazard ratio, 2.07 [95% CI, 1.06-4.05]; =0.034) and acute kidney injury (hazard ratio, 4.35 [95% CI, 2.21-8.55]; <0.001). Interaction testing between RBC transfusion and mortality was not statistically significant in the above-mentioned subgroups, and such association was not documented in the corresponding propensity score-matched cohorts. In the multivariable Cox proportional hazards regression model, major vascular complications (=0.044), major bleeding (=0.041), and RBC transfusion (=0.048) were independent correlates of 30-day mortality.
Conclusions
RBC transfusion correlates with increased mortality and acute kidney injury early after transcatheter aortic valve replacement and is an independent predictor of 30-day mortality, irrespective of periprocedural major bleeding and vascular complications.
Registration
URL: https://www.clinicaltrials.gov. Unique identifier: NCT03740425.



Circ Cardiovasc Interv: 03 Dec 2020:CIRCINTERVENTIONS120009026; epub ahead of print
Zimarino M, Barbanti M, Dangas GD, Testa L, ... Bedogni F, Tamburino C
Circ Cardiovasc Interv: 03 Dec 2020:CIRCINTERVENTIONS120009026; epub ahead of print | PMID: 33272037
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Abstract

Intravascular Imaging-Guided Percutaneous Coronary Intervention: A Universal Approach for Optimization of Stent Implantation.

Shlofmitz E, Ali ZA, Maehara A, Mintz GS, Shlofmitz R, Jeremias A

Despite consistent clinical data supporting the use of intravascular imaging with percutaneous coronary intervention, utilization remains low. A practical and standardized approach to incorporating intravascular imaging with percutaneous coronary intervention may overcome the barriers to utilization. This review focuses on basic image interpretation with intravascular ultrasound and optical coherence tomography and proposes an algorithmic approach to stent sizing and optimization. Incorporation of this strategic method for percutaneous coronary intervention may aid in the greater adoption of intravascular imaging for percutaneous coronary intervention.



Circ Cardiovasc Interv: 29 Nov 2020; 13:e008686
Shlofmitz E, Ali ZA, Maehara A, Mintz GS, Shlofmitz R, Jeremias A
Circ Cardiovasc Interv: 29 Nov 2020; 13:e008686 | PMID: 33233934
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Abstract

Individualized, Intraoperative Dosing of Fibrinogen Concentrate for the Prevention of Bleeding in Neonatal and Infant Cardiac Surgery Using Cardiopulmonary Bypass (FIBCON): A Phase 1b/2a Randomized Controlled Trial.

Siemens K, Hunt BJ, Harris J, Nyman AG, Parmar K, Tibby SM
Background
Mediastinal bleeding is common following pediatric cardiopulmonary bypass surgery for congenital heart disease. Fibrinogen concentrate (FC) represents a potential therapy for preventing bleeding.
Methods
We performed a single-center, phase 1b/2a, randomized controlled trial on infants 2.5 to 12 kg undergoing cardiopulmonary bypass surgery, aimed at (1) demonstrating the feasibility of an intraoperative point-of-care test, rotational thromboelastometry, to screen out patients at low risk of postoperative bleeding and then guide individualized FC dosing in high-risk patients and (2) determining the dose, safety, and efficacy of intraoperative FC supplementation. Screening occurred intraoperatively 1-hour before bypass separation using the rotational thromboelastometry variable fibrinogen thromboelastometry maximum clot firmness (FibTEM-MCF; fibrinogen contribution to clot firmness). If FibTEM-MCF ≥7 mm, patients entered the monitoring cohort. If FibTEM-MCF ≤6 mm, patients were randomized to receive FC/placebo (2:1 ratio). Individualized FC dose calculation included weight, bypass circuit volume, hematocrit, and intraoperative measured and desired FibTEM-MCF. The coprimary outcomes, measured 5 minutes post-FC administration were FibTEM-MCF (desired range, 8-13 mm) and fibrinogen levels (desired range, 1.5-2.5 g/L). Secondary outcomes were thrombosis and thrombosis-related major complications and postoperative 24-hour mediastinal blood loss.
Results
We enrolled 111 patients (cohort, n=21; FC, n=60; placebo, n=30); mean (SD) age, 6.4 months (5.8); weight, 5.9 kg (2.0). Intraoperative rotational thromboelastometry screening effectively excluded low-risk patients, in that none in the cohort arm (FibTEM-MCF, ≥7 mm) demonstrated clinically significant early postoperative bleeding (>10 mL/kg per 4 hours). Among randomized patients, the median (range) FC administered dose was 114 mg/kg (51-218). Fibrinogen levels increased from a mean (SD) of 0.91 (0.22) to 1.7 g/L (0.41). The postdose fibrinogen range was 1.2 to 3.3 g/L (72% within the desired range). The corresponding FibTEM-MCF values were as follows: pre-dose, 5.3 mm (1.9); post-dose, 13 mm (3.2). Ten patients (8 FC and 2 placebo) exhibited 12 possible thromboses; none were clearly related to FC. There was an overall difference in mean (SD) 24-hour mediastinal drain loss: cohort, 12.6 mL/kg (6.4); FC, 11.6 mL/kg (5.2); placebo, 17.1 mL/kg (14.3; ANOVA =0.02).
Conclusions
Intraoperative, individualized dosing of FC appears feasible. The need for individualized dosing is supported by the finding that a 4-fold variation in FC dose is required to achieve therapeutic fibrinogen levels. Registration: URL: https://eudract.ema.europa.eu/; Unique identifier: 2013-003532-68. URL: https://www.isrctn.com/; Unique identifier: 50553029.



Circ Cardiovasc Interv: 29 Nov 2020; 13:e009465
Siemens K, Hunt BJ, Harris J, Nyman AG, Parmar K, Tibby SM
Circ Cardiovasc Interv: 29 Nov 2020; 13:e009465 | PMID: 33213194
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Impact:
Abstract

Simple Diagnostic Tools May Guide Transcatheter Closure of Superior Sinus Venosus Defects Without Advanced Imaging Techniques.

Sivakumar K, Qureshi S, Pavithran S, Vaidyanathan S, Rajendran M
Background
There is a recent interest in nonsurgical correction of superior sinus venosus defects. Patient selection is currently based on advanced imaging and printing technologies. Simple clinical tools to select patients will expand its applicability in developing countries.
Methods
Defects caudally extending toward the oval fossa and right upper pulmonary veins draining beyond the cavoatrial junction on transesophageal echocardiography were excluded. Balloon interrogation of cavoatrial junction confirmed complete occlusion of the defect with unobstructed pulmonary venous drainage to left atrium. Single long covered stents or overlapping covered stents were used to exclude sinus venosus defects. Closure of left-to-right interatrial shunt without causing pulmonary vein occlusion was confirmed on follow-up imaging.
Results
Forty-four patients selected after transesophageal echocardiography underwent balloon interrogation with monitoring of right upper pulmonary vein. Eighteen out of 44 patients were ineligible. Twenty-four eligible patients with closure of left-to-right interatrial shunt without pulmonary vein occlusion underwent covered stent exclusion using single long stents in 15 and overlapping stents in the rest, while 2 patients are awaiting the procedure. Four patients aged 6 to 16 years received stents that were 18 mm or larger. Three patients had stent embolization that required surgical correction in 2 but in the last patient was managed nonsurgically with an overlapping covered stent with good final outcomes. Procedure was successful in 22 patients. At a median follow-up of 20 months (range, 3-54 months), there were no adverse events. Follow-up imaging showed trivial left-to-right shunt in 4 and unobstructed pulmonary veins in all patients.
Conclusions
Transesophageal echocardiography and balloon interrogation identified 60% of the patients with sinus venosus defects to be eligible for catheter closure. Overlapping stents are an alternative to custom-made long stents. Transesophageal echocardiography confirms procedural success on follow-up. Advanced imaging and printing technologies are not essential for successful outcomes and thus simple tests increase the feasibility in developing countries.



Circ Cardiovasc Interv: 29 Nov 2020; 13:e009833
Sivakumar K, Qureshi S, Pavithran S, Vaidyanathan S, Rajendran M
Circ Cardiovasc Interv: 29 Nov 2020; 13:e009833 | PMID: 33233933
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Abstract

Microvascular Assessment of Ranolazine in Non-Obstructive Atherosclerosis: The MARINA Randomized, Double-Blinded, Controlled Pilot Trial.

Koh JS, Hung OY, Eshtehardi P, Kumar A, ... Quyyumi AA, Samady H
Background
Microvascular dysfunction is known to play a key role in patients with angina and nonobstructive coronary artery disease. We investigated the impact of ranolazine among patients with angina and nonobstructive coronary artery disease.
Methods
In this randomized, double-blinded, placebo-controlled pilot trial, 26 patients with angina once weekly or more, abnormal stress test, and nonobstructive coronary artery disease (<50% stenosis by angiography and fractional flow reserve >0.80) were randomized 1:1 to ranolazine or placebo for 12 weeks. Primary end point was ΔSeattle Angina Questionnaire (SAQ) angina frequency score. Baseline and 3 months follow-up SAQ, Duke Activity Status Index scores along with invasive fractional flow reserve, coronary flow reserve (CFR), hyperemic myocardial resistance, and cardiopulmonary exercise testing measurements were performed.
Results
No significant differences in ΔSAQ angina frequency scores (=0.53) or Duke Activity Status Index (=0.76) were observed between ranolazine versus placebo, although patients on ranolazine had lesser improvement in SAQ physical limitation scores (=0.02) compared with placebo at 3 months. There were no significant differences in ΔCFR or Δhyperemic myocardial resistance between ranolazine and placebo groups. Patients treated with ranolazine, compared with placebo, had no significant improvement in maximum rate of oxygen consumption measured during incremental exercise (VO max) and peak metabolic equivalents of task. Interestingly, in the ranolazine group, patients with baseline CFR<2.0 demonstrated greater gain in CFR compared with those with baseline CFR≥2.0 (=0.02).
Conclusions
Ranolazine did not demonstrate improvement in SAQ angina frequency score, invasive microvascular function, or peak metabolic equivalent compared with placebo at 3 months. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02147067.



Circ Cardiovasc Interv: 29 Nov 2020; 13:e008204
Koh JS, Hung OY, Eshtehardi P, Kumar A, ... Quyyumi AA, Samady H
Circ Cardiovasc Interv: 29 Nov 2020; 13:e008204 | PMID: 33272036
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Abstract

A Randomized Trial Evaluating Online 3-Dimensional Optical Frequency Domain Imaging-Guided Percutaneous Coronary Intervention in Bifurcation Lesions.

Onuma Y, Kogame N, Sotomi Y, Miyazaki Y, ... Okamura T,
Background
Clinical implications of online 3-dimensional optical frequency domain imaging (3D-OFDI)-guided stenting for bifurcation lesions have not been investigated in the randomized controlled trials. The purpose of this study was to determine whether online 3D-OFDI-guided stenting is superior to angiography-guided percutaneous coronary intervention (PCI) in terms of incomplete stent apposition at the bifurcation segment.
Methods
The OPTIMUM trial (Online 3-Dimensional Optical Frequency Domain Imaging to Optimize Bifurcation Stenting Using UltiMaster Stent) was a randomized, multicenter clinical trial. Eligible patients had an angiographically significant stenosis in the bifurcation lesion treated with a provisional single stent strategy using the Ultimaster sirolimus eluting stent. Patients were randomly allocated to either online 3D-OFDI-guided or angiography-guided PCI. Patients randomized to 3D-OFDI guidance underwent online 3D-OFDI assessment after rewiring into the jailed side branch after stenting and proximal optimization technique, while in the angiography guidance arm, rewiring was performed using conventional fluoroscopic/angiographic guidance. The primary end point of this trial was the postprocedural average percentage of malapposed struts per lesion assessed by OFDI in the confluence zone of the main and side branches.
Results
Between June 8, 2017 and September 26, 2018, 110 patients with 111 bifurcation lesions were randomized at 4 Japanese centers. Of these, 56 patients with 57 lesions were treated with 3D-OFDI-guided PCI, whereas 54 patients with 54 lesions were treated with angiography-guided PCI. In the 3D-OFDI guidance arm, the feasibility of online 3D-OFDI was 98.2%. The average percentage of incomplete stent apposition per lesion at bifurcation was lower in the 3D-OFDI guidance arm than that in the angiography guidance arm (19.5±15.8% versus 27.5±14.2%, =0.008). The superiority of the 3D-OFDI guidance arm was also confirmed in the strut level analysis (odds ratio: 0.54 [95% CI, 0.36-0.81]; =0.003).
Conclusions
Online 3D-OFDI-guided bifurcation PCI was superior to angiography-guided bifurcation PCI in terms of acute incomplete stent apposition at bifurcation. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02972489.



Circ Cardiovasc Interv: 29 Nov 2020; 13:e009183
Onuma Y, Kogame N, Sotomi Y, Miyazaki Y, ... Okamura T,
Circ Cardiovasc Interv: 29 Nov 2020; 13:e009183 | PMID: 33272034
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Abstract

Risk of Coronary Obstruction and Feasibility of Coronary Access After Repeat Transcatheter Aortic Valve Replacement With the Self-Expanding Evolut Valve: A Computed Tomography Simulation Study.

Forrestal BJ, Case BC, Yerasi C, Shea C, ... Waksman R, Rogers T
Background
The supra-annular leaflet position and tall stent frame of the self-expanding Evolut PRO or Evolut PRO+ transcatheter heart valves (THVs) may cause coronary occlusion during transcatheter aortic valve replacement (TAVR)-in-TAVR and present challenges for future coronary access. We sought to evaluate the risk of TAVR-in-TAVR with Evolut PRO or Evolut PRO+ THVs and the feasibility of future coronary access.
Methods
The CoreValve Evolut PRO Prospective Registry (EPROMPT; NCT03423459) prospectively enrolled patients with symptomatic severe aortic stenosis to undergo TAVR using a commercially available latest generation self-expanding THV at 2 centers in the United States. Computed tomography was performed 30 days after TAVR, which we used to simulate TAVR-in-TAVR with a second Evolut PRO or Evolut PRO+ THV and evaluate for risk of coronary obstruction and feasibility of future coronary access.
Results
Eighty-one patients enrolled with interpretable computed tomography are reported herein. Computed tomography simulation predicted sinus of Valsalva sequestration and resultant coronary obstruction during future TAVR-in-TAVR in up to 23% of patients. Computed tomography simulation predicted that the position of the pinned THV leaflets would hinder future coronary access in up to 78% of patients after TAVR-in-TAVR.
Conclusions
Further THV design improvements and leaflet modification strategies are needed to mitigate the risk of coronary obstruction during TAVR-in-TAVR with self-expanding THVs and to facilitate future coronary access. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03423459.



Circ Cardiovasc Interv: 29 Nov 2020; 13:e009496
Forrestal BJ, Case BC, Yerasi C, Shea C, ... Waksman R, Rogers T
Circ Cardiovasc Interv: 29 Nov 2020; 13:e009496 | PMID: 33272031
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Impact:
Abstract

Self-Expandable Nitinol Stents for the Treatment of Nonmalignant Deep Venous Obstruction.

Sebastian T, Gnanapiragasam S, Spirk D, Engelberger RP, ... Barco S, Kucher N
Background
Angioplasty with stent placement is a therapeutic option for patients with acute thrombotic, postthrombotic, and nonthrombotic obstruction of the iliofemoral veins or inferior vena cava. Previous studies of steel-alloy stents described variable patency rate across indications.
Methods
The prospective Swiss Venous Stent Registry includes patients treated with self-expandable nitinol stents for deep venous obstruction. Routine follow-up visits include serial duplex ultrasound for stent patency assessment. The primary outcome was primary stent patency. The secondary outcome was venous thromboembolisms. We studied the rate of stent occlusion and potentially contributing factors.
Results
We included 379 patients: 160 with acute thrombotic, 193 with postthrombotic, and 26 with nonthrombotic deep vein obstruction. The mean age was 46±18 years; 55% were women. The cumulative 3-year primary patency rate was 80.5% (95% CI, 73.0%-88.0%) for acute thrombotic, 59.2% (95% CI, 50.4%-68.0%) for postthrombotic, and 100% for nonthrombotic obstruction (log-rank, <0.0001). Annualized rates of stent occlusion or venous thromboembolism were 7.8 (acute thrombotic), 15.0 (postthrombotic), and 0 (nonthrombotic) events/100 patient-years. In a multivariable Cox regression model, postthrombotic femoral veins at baseline (hazard ratio, 2.64 [95% CI, 1.53-4.56]) and the number of stents (hazard ratio, 1.22 [95% CI, 1.06-1.40]) were associated with stent occlusion after conditioning for age, sex, and clinically relevant factors.
Conclusions
The rate of stent occlusion (patency loss) and venous thromboembolism varies substantially across indications, also with dedicated venous nitinol stents. Patients with postthrombotic femoral veins and those who received multiple stents were characterized by the highest risk. Registration: URL: https://clinicaltrials.gov. Unique identifier: NCT02433054.



Circ Cardiovasc Interv: 29 Nov 2020; 13:e009673
Sebastian T, Gnanapiragasam S, Spirk D, Engelberger RP, ... Barco S, Kucher N
Circ Cardiovasc Interv: 29 Nov 2020; 13:e009673 | PMID: 33272030
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Abstract

Valve-in-Valve and Valve-in-Ring Transcatheter Mitral Valve Implantation in Young Women Contemplating Pregnancy.

Fuchs A, Urena M, Chong-Nguyen C, Kikoïne J, ... Iung B, Himbert D
Background
Transcatheter mitral valve implantation (TMVI) is emerging as an alternative to surgical mitral valve replacement in selected high-risk patients. Delaying definitive mechanical mitral valve replacement and the constraints of anticoagulation thanks to TMVI may be an attractive option in young women contemplating pregnancy and suffering from failure of mitral bioprosthesis or annuloplasty. The aim of the study was to evaluate the possibility, safety, and outcomes of pregnancy after TMVI in this population.
Methods
From 2013 to 2019, 12 young women contemplating pregnancy underwent transseptal valve-in-valve or valve-in-ring TMVI using the Edwards SAPIEN XT/3 valves and were prospectively followed up at 1 month, 6 months, 1 year, and yearly thereafter.
Results
Mean age of the patients was 30±6 years. Bioprosthesis degeneration was observed in 7 cases and annuloplasty failure in 5. Three valve-in-ring patients required the implantation of a second valve, which led to an overall procedural success rate of 75%. One delayed left ventricular outflow tract obstruction required elective surgical mitral valve replacement. At 6 months/1 year, 83% of the patients were in New York Heart Association classes I/II. Mitral regurgitation was ≤2+ in all the cases and mean gradient was 7±2 mm Hg. Four patients could complete 6 full-term pregnancies. One symptomatic thrombosis occurred and resolved under aspirin and anticoagulation therapy. All others pregnancies were uneventful. Predelivery mean gradient was 11 mm Hg, and systolic pulmonary artery pressure was 32 mm Hg. There were 4 vaginal deliveries and 2 cesarians. Newborns were alive and healthy. At last follow-up, there was no death, and 3 patients required elective surgical mitral valve replacement at 6- to 54-month follow-up.
Conclusions
Our study suggests that, in young women, transseptal TMVI to treat failing bioprostheses may result in good short-term outcomes that allow uneventful pregnancies. The results are less favorable in women with failed annuloplasty rings.



Circ Cardiovasc Interv: 29 Nov 2020; 13:e009579
Fuchs A, Urena M, Chong-Nguyen C, Kikoïne J, ... Iung B, Himbert D
Circ Cardiovasc Interv: 29 Nov 2020; 13:e009579 | PMID: 33320712
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Abstract

Efficacy of MAVIG X-Ray Protective Drapes in Reducing Operator Radiation Dose in the Cardiac Catheterization Laboratory: A Randomized Controlled Trial.

McCutcheon K, Vanhaverbeke M, Pauwels R, Dabin J, ... Sinnaeve P, Desmet W
Background
Interventional cardiologists are occupationally exposed to high doses of ionizing radiation. The MAVIG X-ray protective drape (MXPD) is a commercially available light weight, lead-free shield placed over the pelvic area of patients to minimize operator radiation dose. The aim of this study was to examine the efficacy of the MXPD during routine cardiac catheterization, including percutaneous coronary interventions.
Methods
We performed a prospective, randomized controlled study comparing operator radiation dose during cardiac catheterization and percutaneous coronary intervention (n=632) with or without pelvic MXPD. We measured operator radiation dose at 4 sites: left eye, chest, left ring finger, and right ring finger. The primary outcomes were the difference in first operator radiation dose (µSv) and relative dose of the first operator (radiation dose normalized for dose area product) at the level of the chest in the 2 groups.
Results
The use of the MXPD was associated with a 50% reduction in operator radiation dose (median dose 30.5 [interquartile range, 23.0-39.7] µSv in no drape group versus 15.3 [interquartile range, 11.1-20.0] µSv in the drape group; <0.001) and a 57% reduction in relative operator dose (<0.001). The largest absolute reduction in dose was observed at the left finger (median left finger dose for the no drape group was 104.9 [75.7-137.4] µSv versus 41.9 [32.6-70.6] µSv in the drape group; <0.001).
Conclusions
The pelvic MXPD significantly reduces first operator radiation dose during routine cardiac catheterization and percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT04285944.



Circ Cardiovasc Interv: 30 Oct 2020; 13:e009627
McCutcheon K, Vanhaverbeke M, Pauwels R, Dabin J, ... Sinnaeve P, Desmet W
Circ Cardiovasc Interv: 30 Oct 2020; 13:e009627 | PMID: 33092401
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Abstract

Comparison Between Optical Frequency Domain Imaging and Intravascular Ultrasound for Percutaneous Coronary Intervention Guidance in Biolimus A9-Eluting Stent Implantation: A Randomized MISTIC-1 Non-Inferiority Trial.

Muramatsu T, Ozaki Y, Nanasato M, Ishikawa M, ... Izawa H,
Background
Given the characteristic differences between intravascular ultrasound (IVUS) and optical frequency domain imaging (OFDI), their approach to therapeutic guidance during percutaneous coronary interventions (PCIs) and arterial healing response after stenting may also vary.
Methods
MISTIC-1 (The Multimodality Imaging Study in Cardiology cohort 1) is a multicenter, randomized-controlled, noninferiority trial that compared imaging end points between OFDI- and IVUS-guided PCI. Patients with stable coronary artery disease were randomly assigned to either OFDI- or IVUS-guided PCI using a Biolimus A9-eluting stent according to a prespecified protocol for imaging guidance. Stent sizing was based on external elastic lamina in IVUS-guided PCI while lumen up-size in OFDI-guided PCI. Postprocedural OFDI was investigated regardless of randomization, while operators in IVUS-guided PCI arm were blinded to the images. The primary end point was in-segment minimum lumen area assessed using OFDI at 8 months, while the secondary end point was a composite of cardiovascular mortality, target-vessel myocardial infarction, or target-lesion revascularization (device-oriented composite end point). Patients were followed up to 3 years after the index procedure.
Results
A total of 109 patients (mean age 70 years, male 78%) with 126 lesions were enrolled. Postprocedural minimum stent area was 6.31±1.89 and 6.72±2.08 mm in OFDI and IVUS group, respectively (=0.26). At the 8-month follow-up, in-segment minimum lumen area was 4.56±1.94 and 4.13±1.86 mm in OFDI and IVUS group, respectively ( <0.001). Both groups had comparable neointimal healing score (median 0.16 [interquartile range, 0.00-3.14] versus 0.90 [0.00-3.30], respectively; =0.43). The incidence rate of device-oriented composite end point at 3 years was 7.4% and 7.3% in OFDI and IVUS group, respectively (hazard ratio, 1.05 [95% CI, 0.26-4.18]; =0.95).
Conclusions
OFDI-guided PCI was not inferior to IVUS-guided PCI in terms of in-segment minimum lumen area at 8 months. Although a small sample size was acknowledged, OFDI could be an alternative to IVUS when considering intracoronary imaging-guided PCI in selected populations with coronary artery diseases. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03292081.



Circ Cardiovasc Interv: 30 Oct 2020; 13:e009314
Muramatsu T, Ozaki Y, Nanasato M, Ishikawa M, ... Izawa H,
Circ Cardiovasc Interv: 30 Oct 2020; 13:e009314 | PMID: 33106049
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Impact:
Abstract

Feasibility of Transcatheter Aortic Valve Replacement in Prior Aortic Root Surgery: Insights From Virtual Modeling.

Brener MI, Yamabe T, Leb J, Khalique OK, Takayama H, George I
Background
Aortic root replacement (ARR) introduces several anatomic complexities relevant to valve-in-valve (VIV)-transcatheter aortic valve replacement (TAVR) that may (1) increase the risk of coronary obstruction, (2) necessitate transcatheter valve overexpansion to accommodate large annuli, and (3) require alternative vascular access to navigate aortic kinking. Therefore, we aimed to quantify the feasibility of VIV-TAVR in patients who underwent aortic root surgery.
Methods
Postoperative computed tomography scans were reviewed for consecutive patients who underwent ARR between 2005 and 2019 to obtain measurements relevant for VIV-TAVR planning. Virtual transcatheter valve to coronary ostia distance was measured to assess the risk of coronary obstruction. Root morphologies were classified into 1 of 4 groups based on aortic graft type, aortic diameter at the sinotubular junction, sinus height, estimated transcatheter heart valve height, and diameter. VIV-TAVR was projected to be complex in patients with an aortic kink, extremely large annulus, or heightened risk of coronary obstruction.
Results
Among 848 patients who underwent ARR during the 15-year study period, qualifying contrast-enhanced scans post-ARR were performed in 81 patients. Complex VIV-TAVR was anticipated in 50.6% of subjects. Patients with abnormal root anatomy experienced increased odds of complex VIV-TAVR relative to patients with normal root physiology (ie, sinotubular junction diameter>transcatheter heart valve diameter, sinus height>transcatheter heart valve height) or those who received straight tube grafts (odds ratio, 4.53 [95% CI, 1.02-20.1], =0.046). The odds of complex VIV-TAVR were also higher among patients who underwent aortic valve replacement-ARR with a stentless bioprosthesis (stentless versus stented, odds ratio, 4.63 [95% CI, 1.40-15.3], =0.012; stentless versus valve-sparing ARR, odds ratio, 3.78 [95% CI, 1.14-12.5], =0.029).
Conclusions
ARR patients with atypical root morphologies or those who underwent valve replacement with stentless bioprostheses may be at high risk for complex VIV-TAVR. Prospective evaluation is required to assess the impact of these conclusions on procedural feasibility.



Circ Cardiovasc Interv: 30 Oct 2020; 13:e009539
Brener MI, Yamabe T, Leb J, Khalique OK, Takayama H, George I
Circ Cardiovasc Interv: 30 Oct 2020; 13:e009539 | PMID: 33131300
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Impact:
Abstract

DISENGAGE Registry.

Pellicano M, Ciccarelli G, Xaplanteris P, Di Gioia G, ... De Bruyne B, Barbato E
Background
During fractional flow reserve (FFR) measurement, the simple presence of the guiding catheter (GC) within the coronary ostium might create artificial ostial stenosis, affecting the hyperemic flow. We aimed to investigate whether selective GC engagement of the coronary ostium might impede hyperemic flow, and therefore impact FFR measurements and related clinical decision-making.
Methods
In the DISENGAGE (Determination of Fractional Flow Reserve in Intermediate Coronary Stenosis With Guiding Catheter Disengagement) registry, FFR was prospectively measured twice (with GC engaged [FFR] and disengaged [FFR]) in 202 intermediate stenoses of 173 patients. We assessed (1) whether ΔFFR-FFR was significantly different from the intrinsic variability of repeated FFR measurements (test-retest repeatability); (2) whether the extent of ΔFFR-FFR could be clinically significant and therefore able to impact clinical decision-making; and (3) whether ΔFFR-FFR related to the stenosis location, that is, proximal and middle versus distal coronary segments.
Results
Overall, FFR significantly changed after GC disengagement: FFR 0.84±0.08 versus FFR 0.80±0.09, <0.001. Particularly, in 38 stenoses (19%) with FFR values in the 0.81 to 0.85 range, GC disengagement was associated with a shift from above to below the 0.80 clinical cutoff, resulting into a change of the treatment strategy from medical therapy to percutaneous coronary intervention. The impact of GC disengagement was significantly more pronounced with stenoses located in proximal and middle as compared with distal coronary segments (ΔFFR-FFR, proximal and middle 0.04±0.03 versus distal segments 0.03±0.03; =0.042).
Conclusions
GC disengagement results in a shift of FFR values from above to below the clinical cutoff FFR value of 0.80 in 1 out of 5 measurements. This occurs mostly when the stenosis is located in proximal and middle coronary segments and the FFR value is close to the cutoff value.



Circ Cardiovasc Interv: 30 Oct 2020; 13:e008640
Pellicano M, Ciccarelli G, Xaplanteris P, Di Gioia G, ... De Bruyne B, Barbato E
Circ Cardiovasc Interv: 30 Oct 2020; 13:e008640 | PMID: 33131299
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Impact:
Abstract

One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients.

Kandzari DE, Kirtane AJ, Windecker S, Latib A, ... Stone GW,
Background
Despite treatment guidance endorsing shortened dual antiplatelet therapy (DAPT) duration in high bleeding risk (HBR) patients after drug-eluting stents, limited evidence exists to support these recommendations. The present study was designed to examine the safety and effectiveness of 1-month DAPT duration following percutaneous coronary intervention with zotarolimus-eluting stents in HBR patients.
Methods
Onyx ONE Clear was a prospective, multicenter, nonrandomized study evaluating the safety and effectiveness of 1-month DAPT followed by single antiplatelet therapy in HBR patients undergoing percutaneous coronary intervention with Resolute Onyx drug-eluting stents. The primary analysis of cardiac death or myocardial infarction between 1 month and 1 year was performed in the prespecified one-month clear population of patients pooled from the Onyx ONE US/Japan study and Onyx ONE randomized controlled trial. One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention.
Results
Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% (<0.001).
Conclusions
Among HBR patients who were event free before DAPT discontinuation at 1 month, favorable safety and effectiveness through 1 year support treatment with Resolute Onyx drug-eluting stents as part of an individualized strategy for shortened DAPT duration following percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier NCT03647475.



Circ Cardiovasc Interv: 30 Oct 2020; 13:e009565
Kandzari DE, Kirtane AJ, Windecker S, Latib A, ... Stone GW,
Circ Cardiovasc Interv: 30 Oct 2020; 13:e009565 | PMID: 33167705
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Impact:
Abstract

Balloon Angioplasty for Native Aortic Coarctation in 3- to 12-Month-Old Infants.

Sandoval JP, Kang SL, Lee KJ, Benson L, Asoh K, Chaturvedi RR
Background
Balloon angioplasty for native coarctation of the aorta (CoA) is successful in children and adults but in neonates results in frequent restenosis. The efficacy of balloon angioplasty for native CoA during infancy beyond the neonatal period was examined in infants aged 3 to 12 months of age.
Methods
A retrospective review of 68 infants who underwent balloon angioplasty for native CoA. 95% CI are in parentheses.
Results
Procedural age was (mean±SD) 6±3.4 months and weight was 7±1.8 kg. Balloon angioplasty produced a large decrease in both the noninvasive arm-to-leg blood pressure gradient (41.2±18.7 to 5.6±9.6 mm Hg) and the invasive peak systolic pressure gradient (34±12 to 11±9 mm Hg). Balloon angioplasty increased the CoA diameter from 2.7±1 mm to 4.6±1.2 mm. One patient was lost to follow-up. A catheter reintervention was required in 11.8% and surgery in 10.3%. The hazard of reintervention was highest early. Median freedom from reintervention was 89% (95% CI, 80%-96%) at 1 year, 83% (95% CI, 73%-92%) at 5 years, and 81% (95% CI, 69%-90%) at 10 years. Femoral artery thrombosis was documented in 6 (9%) infants without any long-term consequence. One patient developed a small aortic aneurysm late and has not required treatment. A robust estimate of the frequency of aortic aneurysms remains to be determined as the majority of subjects have not had cross-sectional imaging.
Conclusions
Balloon angioplasty of native CoA is effective and safe in infants aged 3 to 12 months with outcomes comparable to those in older children and adults. Catheter reinterventions can avoid the need for surgery in most patients.



Circ Cardiovasc Interv: 30 Oct 2020; 13:e008938
Sandoval JP, Kang SL, Lee KJ, Benson L, Asoh K, Chaturvedi RR
Circ Cardiovasc Interv: 30 Oct 2020; 13:e008938 | PMID: 33167702
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Impact:
Abstract

Increasing Wait-Time Mortality for Severe Aortic Stenosis: A Population-Level Study of the Transition in Practice From Surgical Aortic Valve Replacement to Transcatheter Aortic Valve Replacement.

Albassam O, Henning KA, Qiu F, Cram P, ... Austin PC, Wijeysundera HC
Background
Transcatheter aortic valve replacement (TAVR) has emerged as a reasonable alternative to surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis (AS). There is limited data on temporal trends in wait-times and access to care for patients with AS, irrespective of treatment modality. We sought to investigate the trends in wait-times for the treatment (either SAVR or TAVR) of AS in Ontario, Canada, and to understand the drivers of wait-list mortality and hospitalization due to heart failure.
Methods
In this population-level retrospective cohort study, we identified patients from April 1, 2012, to March 31, 2018, who were referred for treatment of symptomatic severe AS awaiting either SAVR or TAVR. The primary outcome was the median total wait-time from referral date to either SAVR or TAVR procedure. Primary clinical outcomes were all-cause mortality and heart failure-related hospitalizations while on the wait-list.
Results
The referral cohort consisted of a total of 22 876 referrals for aortic valve replacement, with (N=8098) TAVR and (N=14 778) SAVR referrals. The mean and median wait times for the overall AVR cohort were 87 and 59 days, respectively. The TAVR subcohort had longer wait-times (median 84 days) compared with the SAVR subcohort (median 50 days). Year over year, there was a statistically significant an increase in wait-times (<0.001) for the overall AS cohort as well as each of the TAVR (<0.0001) and SAVR (<0.0001) subgroups. Wait-time mortality was 2.5% (TAVR 5.2% and SAVR 1.05%), while the cumulative probability of heart failure hospitalization was 3.6% (TAVR 7.7% and SAVR 1.3%).
Conclusions
In patients with severe symptomatic AS awaiting aortic valve replacement, there has been a trend of increasing wait times for both SAVR and TAVR. This was associated with increasing mortality and hospitalizations related to heart failure while on the wait-list.



Circ Cardiovasc Interv: 30 Oct 2020; 13:e009297
Albassam O, Henning KA, Qiu F, Cram P, ... Austin PC, Wijeysundera HC
Circ Cardiovasc Interv: 30 Oct 2020; 13:e009297 | PMID: 33167700
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