Journal: Circ Cardiovasc Interv

Sorted by: date / impact
Abstract

Frequency, Predictors, Distribution, and Morphological Characteristics of Layered Culprit and Nonculprit Plaques of Patients With Acute Myocardial Infarction: In Vivo 3-Vessel Optical Coherence Tomography Study.

Dai J, Fang C, Zhang S, Li L, ... Mintz GS, Yu B
Background
Subclinical atherothrombosis and plaque healing may lead to rapid plaque progression. The histopathologic healed plaque has a layered appearance when imaged using optical coherence tomography. We assessed the frequency, predictors, distribution, and morphological characteristics of optical coherence tomography layered culprit and nonculprit plaques in patients with acute myocardial infarction.
Methods
A prospective series of 325 patients with acute myocardial infarction underwent optical coherence tomography imaging of all 3 native coronary arteries. Layered plaque phenotype had heterogeneous signal-rich layered tissue located close to the luminal surface that was clearly demarcated from the underlying plaque.
Results
Layered plaques were detected in 74.5% of patients with acute myocardial infarction. Patients with layered culprit plaques had more layered nonculprit plaques; and they more often had preinfarction angina, ST-segment-elevation myocardial infarction, higher low-density lipoprotein cholesterol, and absence of antiplatelet therapy. Layered plaques tended to cluster in the proximal segment of the left anterior descending artery and left circumflex artery but were more uniformly distributed in the right coronary artery. As compared with nonlayered plaques, layered plaques had greater optical coherence tomography lumen area stenosis at both culprit and nonculprit sites. The frequency of layered plaque phenotype (=0.038) and maximum area of layered tissue (<0.001) increased from nonculprit thin-cap fibroatheromas to nonculprit ruptures to culprit ruptures.
Conclusions
Layered plaques were identified in 3-quarters of patients with acute myocardial infarction, especially in the culprit plaques of patients with ST-segment-elevation myocardial infarction. Layered plaques had a limited, focal distribution in the left anterior descending artery, and left circumflex artery but were more evenly distributed in the right coronary artery and were characterized by greater lumen narrowing at both culprit and nonculprit sites.



Circ Cardiovasc Interv: 21 Sep 2020:CIRCINTERVENTIONS120009125; epub ahead of print
Dai J, Fang C, Zhang S, Li L, ... Mintz GS, Yu B
Circ Cardiovasc Interv: 21 Sep 2020:CIRCINTERVENTIONS120009125; epub ahead of print | PMID: 32957793
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Hybrid Coronary Revascularization Versus Conventional Coronary Artery Bypass Surgery: Utilization and Comparative Outcomes.

Hannan EL, Wu Y, Cozzens K, Sundt TM, ... Lahey SJ, Jordan D
Background
Hybrid coronary revascularization (HCR) treats multivessel coronary artery disease by combining a minimally invasive surgical approach to the left anterior descending artery with percutaneous coronary intervention for non-left anterior descending diseased coronary arteries. The objective of this study is to compare HCR and conventional coronary artery bypass graft (CABG) surgery medium-term outcomes.
Methods
Data from multivessel disease patients in New York\'s cardiac surgery and percutaneous coronary intervention registries in 2010 to 2016 were used to compare mortality and repeat revascularization rates for HCR and conventional CABG after using propensity matching to reduce selection bias.
Results
There was a total of 303 HCR (0.80%) patients and 37 556 conventional CABG patients after exclusions. After propensity matching, the respective median follow-up times were 3.72 years and 3.76 years. There was no difference between HCR and conventional CABG in survival at 6 years (80.9% versus 85.8%%, adjusted hazard ratio, 1.44 [0.90-2.31]), but HCR had higher mortality excluding deaths during the first year (adjusted hazard ratio, 1.88 [1.10-3.23]). Conventional CABG patients were more likely to be free from repeat revascularization at 6 years than HCR patients (88.2% versus 76.6%; hazard ratio, 2.22 [1.44-3.42]).
Conclusions
HCR is rarely performed for patients with multivessel coronary artery disease. HCR and conventional CABG had no different 6-year mortality rates, but HCR had higher mortality after 1 year and higher rates of subsequent revascularization that were caused by both the need for repeat revascularization in the left anterior descending artery where minimally invasive CABG was performed, and in the coronary arteries where percutaneous coronary intervention was performed.



Circ Cardiovasc Interv: 11 Oct 2020:CIRCINTERVENTIONS120009386; epub ahead of print
Hannan EL, Wu Y, Cozzens K, Sundt TM, ... Lahey SJ, Jordan D
Circ Cardiovasc Interv: 11 Oct 2020:CIRCINTERVENTIONS120009386; epub ahead of print | PMID: 33040581
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Prognostic Value of Quantitative Flow Ratio Based Functional SYNTAX Score in Patients With Left Main or Multivessel Coronary Artery Disease.

Zhang R, Song C, Guan C, Liu Q, ... Dou K, Xu B
Background
The potential impact of quantitative flow ratio (QFR) based functional Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) score (FSS) on prognostication and revascularization strategy choice has not been fully investigated, and the discriminant ability of FSS needs further validation.
Methods
QFR was retrospectively analyzed in left main or patients with multivessel coronary artery disease from the PANDA III trial. A total of 607 patients with analyzable QFR in all vessels were included. FSS was counted by summing the individual scores only in ischemia-producing lesions (vessel QFR ≤0.8). Patients were stratified according to tertiles of SYNTAX score (SS), and 3 groups of FSS were divided by the same cutoff score. The primary end point was 2-year major adverse cardiac events (a composite of cardiac death, any myocardial infarction, or ischemia-driven revascularization).
Results
After calculating the FSS, 16% (96/607) of study patients moved from higher-risk group by SS to lower-risk group. In the low, intermediate, and high FSS group, the cumulative incidence of 2-year major adverse cardiac events was 9.1%, 13.5%, and 22.3% (=0.0004), and the rate of a composite of cardiac death or myocardial infarction (3.8%, 7.3%, and 13.7%, 0.0006) was also increased. Compared with SS, FSS significantly improved risk classification and prognostication (area under the curve of the receiver-operating characteristics 0.65 versus 0.62, 0.0009). Moreover, 6% (38/607) of patients, for whom coronary artery bypass grafting would be recommended according to SS, converted to favor percutaneous coronary intervention after FSS calculation. After multivariate adjustment, FSS was an independent predictor of 2-year major adverse cardiac events (adjusted hazard ratio, 1.05 [95% CI, 1.02-1.07]; =0.0001).
Conclusions
Among patients with left main or multivessel coronary artery disease, FSS showed applicability in prognostication and revascularization strategy choice. An improved scoring system combining anatomy and physiology (FSS) discriminated the risk of adverse events modestly better than anatomic assessment (SS) alone.
Registration
URL: https://www.clinicaltrials.gov. Unique identifier: NCT02017275.



Circ Cardiovasc Interv: 11 Oct 2020:CIRCINTERVENTIONS120009155; epub ahead of print
Zhang R, Song C, Guan C, Liu Q, ... Dou K, Xu B
Circ Cardiovasc Interv: 11 Oct 2020:CIRCINTERVENTIONS120009155; epub ahead of print | PMID: 33040580
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Coronary Artery Bypass Grafting or Fractional Flow Reserve-Guided Percutaneous Coronary Intervention in Diabetic Patients With Multivessel Disease.

Di Gioia G, Soto Flores N, Franco D, Colaiori I, ... Collet C, De Bruyne B
Background
In diabetic patients with multivessel coronary artery disease, coronary artery bypass grafting (CABG) has shown long-term benefits over percutaneous coronary intervention (PCI). Physiology-guided PCI has shown to improve clinical outcomes in multivessel coronary artery disease, though its impact in diabetic patients has never been investigated. We evaluated long-term clinical outcomes of diabetic patients with multivessel coronary artery disease treated with fractional flow reserve (FFR)-guided PCI compared with CABG.
Methods
From 2010 to 2018, 4622 diabetic patients undergoing coronary angiography were screened for inclusion. The inclusion criterion was the presence of at least 2-vessel disease defined as with diameter stenosis ≥50%, in which at least 1 intermediate stenosis (diameter stenosis, 30%-70%) was treated or deferred according to FFR. Inverse probability of treatment weighting analysis was used to account for baseline differences with a contemporary cohort of patients treated with CABG. The primary end point was major adverse cardiovascular and cerebrovascular events, defined as all-cause death, myocardial infarction, revascularization, or stroke.
Results
A total of 418 patients were included in the analysis. Among them, 209 patients underwent CABG and 209 FFR-guided PCI. At 5 years, the incidence of major adverse cardiovascular and cerebrovascular events was higher in the FFR-guided PCI versus the CABG group (44.5% versus 31.9%; hazard ratio, 1.60 [95% CI, 1.15-2.22]; =0.005). No difference was found in the composite of all-cause death, myocardial infarction, or stroke (28.8% versus 27.5%; hazard ratio, 1.05 [95% CI, 0.72-1.53]; =0.81). Repeat revascularization was more frequent with FFR-guided PCI (24.9% versus 8.2%; hazard ratio, 3.51 [95% CI, 1.93-6.40]; <0.001).
Conclusions
In diabetic patients with multivessel coronary artery disease, CABG was associated with a lower rate of major adverse cardiovascular and cerebrovascular events compared with FFR-guided PCI, driven by a higher rate of repeat revascularization. At 5-year follow-up, no difference was observed in the composite of all-cause death, myocardial infarction, or stroke between CABG and FFR-guided PCI.



Circ Cardiovasc Interv: 11 Oct 2020:CIRCINTERVENTIONS120009157; epub ahead of print
Di Gioia G, Soto Flores N, Franco D, Colaiori I, ... Collet C, De Bruyne B
Circ Cardiovasc Interv: 11 Oct 2020:CIRCINTERVENTIONS120009157; epub ahead of print | PMID: 33040579
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Association of Disease Progression With Cardiovascular and Limb Outcomes in Patients With Peripheral Artery Disease: Insights From the EUCLID Trial.

Rymer JA, Mulder H, Narcisse DI, Rockhold F, ... Jones WS, Patel MR
Background
Patients with peripheral artery disease have a high risk of future cardiovascular disease events and mortality. Little is known about the changes in symptom classification over time in patients with peripheral artery disease and the association of changes in symptom classification with subsequent cardiovascular disease events.
Methods
In this analysis of the EUCLID trial (Examining Use of Ticagrelor in Peripheral Artery Disease), we examined the changes in Rutherford classification (RC) of patients over 12 months. We examined the baseline characteristics of patients by change in symptom classification at 12 months (improved=decreased RC, no change, or worsened=increased RC), and the association between changes in symptom classification (RC) at 12 months and subsequent cardiovascular disease events.
Results
Among 12 759 patients, 3240 (25%) were classified as improved by RC at 12 months, 8132 (64%) as no change, and 1387 (11%) as worsened. At 12 months, many patients who were asymptomatic or had mild/moderate claudication at enrollment had no change in symptom classification over 12 months (73.7% and 70.9%). Patients who worsened over 12 months were more likely to have comorbidities (diabetes mellitus and prior myocardial infarction) and more events (myocardial infarction, amputation, and major bleeding) by 12 months postrandomization, all <0.001. Worsened symptom classification over 12 months was associated with increased risk of all-cause death (adjusted hazard ratio, 1.29 [95% CI, 1.03-1.62]), major amputation (adjusted hazard ratio, 4.12 [95% CI, 2.46-6.88]), and a composite of cardiovascular death, myocardial infarction, or stroke (adjusted hazard ratio, 1.30 [95% CI, 1.05-1.62]), all <0.05 after 12 months postrandomization.
Conclusions
Patients with comorbidities and prior history of cardiovascular disease events at baseline and within the first 12 months of the trial were more likely to have worsened symptom classification at 12 months. Worsening symptom classification over 12 months was associated subsequently with an increased risk of all-cause death, amputation, and a composite of cardiovascular death, myocardial infarction, or stroke.



Circ Cardiovasc Interv: 11 Oct 2020:CIRCINTERVENTIONS120009326; epub ahead of print
Rymer JA, Mulder H, Narcisse DI, Rockhold F, ... Jones WS, Patel MR
Circ Cardiovasc Interv: 11 Oct 2020:CIRCINTERVENTIONS120009326; epub ahead of print | PMID: 33040584
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Novel Micro Crown Orbital Atherectomy for Severe Lesion Calcification: Coronary Orbital Atherectomy System Study (COAST).

Redfors B, Sharma SK, Saito S, Kini AS, ... Bhatheja R, Stone GW
Background
Percutaneous coronary intervention of severely calcified lesions carries a high risk of adverse events despite the use of contemporary devices. The Classic Crown Orbital Atherectomy System (OAS) was safe and effective for severely calcified lesion preparation in the ORBIT II study (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) but was not optimized for tight lesions. COAST (Coronary Orbital Atherectomy System Study) evaluated the safety and efficacy of calcified lesion preparation before stent implantation with the Diamondback 360 Micro Crown Coronary OAS, designed for use in tighter lesions.
Methods
COAST was a prospective, multicenter, single-arm study that enrolled 100 patients with severely calcified de novo coronary lesions at 17 sites in the United States and Japan. The primary effectiveness end point was procedural success, defined as stent delivery with residual stenosis <50% without in-hospital major adverse cardiac events (MACE), and the primary safety end point was freedom from MACE (composite of cardiac death, myocardial infarction, or target vessel revascularization) at 30 days.
Results
The OAS Micro Crown was inserted in all patients. A stent was delivered with a residual stenosis <50% in all except one patient (99.0%). Procedural success was achieved in 85 (85.0%) subjects versus 391 (88.9%) in ORBIT II (=0.30), and freedom from MACE at 30 days was achieved in 85.0% versus 89.6% in ORBIT II (=0.21). Freedom from MACE was 77.8% at 1 year.
Conclusions
Prestent preparation of severely calcified lesions using the novel Micro Crown OAS resulted in similar rates of procedural success and freedom from MACE compared with the Classic Crown OAS. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02132611.



Circ Cardiovasc Interv: 30 Jul 2020; 13:e008993
Redfors B, Sharma SK, Saito S, Kini AS, ... Bhatheja R, Stone GW
Circ Cardiovasc Interv: 30 Jul 2020; 13:e008993 | PMID: 32757661
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Percutaneous Interventions for Secondary Mitral Regurgitation.

Ali M, Shreenivas SS, Pratt DN, Lynch DR, Kereiakes DJ

Mitral regurgitation is frequently associated with ventricular dysfunction and carries a high mortality. Guideline-directed medical therapy, surgical mitral valve repair or replacement, and, in the setting of advanced heart failure, heart transplant and left ventricular assist devices have been the mainstay of treatment. However, rapid advancement in the field has resulted in approval of edge-to-edge mitral valve repair with the MitraClip, and there are several novel catheter-based percutaneous options in clinical trials. Percutaneous options, while promising, must be deployed in patients who are most likely to benefit, and thus, understanding the pathophysiology of specific subgroups of patients with functional mitral regurgitation (eg, disproportionate versus proportionate mitral regurgitation) is key to the success of new devices. We review the pathophysiology, percutaneous therapeutic treatment options, and ongoing clinical trials for functional mitral regurgitation.



Circ Cardiovasc Interv: 30 Jul 2020; 13:e008998
Ali M, Shreenivas SS, Pratt DN, Lynch DR, Kereiakes DJ
Circ Cardiovasc Interv: 30 Jul 2020; 13:e008998 | PMID: 32757659
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

One-Year Echocardiographic, Functional, and Quality of Life Outcomes After Ultrasound-Facilitated Catheter-Based Fibrinolysis for Pulmonary Embolism.

Piazza G, Sterling KM, Tapson VF, Ouriel K, ... Liu PY, Goldhaber SZ
Background
Accelerated tPA (tissue-type plasminogen activator) dosing regimens for ultrasound-facilitated, catheter-directed fibrinolysis improve short-term computed tomographic-measured right ventricular (RV)-to-left ventricular diameter ratio in massive and submassive pulmonary embolism. The impact on RV remodeling, functional status, and quality of life over the long-term remains unclear.
Methods
To study 1-year changes in RV remodeling, functional status, and quality of life, we assessed patients with acute submassive pulmonary embolism randomly assigned to 1 of 4 tPA dosing regimens for ultrasound-facilitated, catheter-directed fibrinolysis in the OPTALYSE-PE trial (Optimum Duration and Dose of r-tPA With the Acoustic Pulse Thrombolysis Procedure for Intermediate-Risk Pulmonary Embolism; 8 mg/2 hours, 8 mg/4 hours, 12 mg/6 hours, and 24 mg/6 hours). Echocardiographic assessment included RV-to-left ventricular diameter ratio within 4 hours of treatment end, and at 48 hours, 30 days, 90 days, and 1 year. Functional status was assessed by 6-minute walk test at 30 days, 90 days, and 1 year and PROMIS-PF-6b scores at 30 days, 90 days, 180 days, 270 days, and 1 year. Quality of life was evaluated by PEmb-QOL scores at 30 days, 90 days, 180 days, 270 days, and 1 year.
Results
Mean RV-to-left ventricular diameter ratio decreased from baseline to 4 hours and further at 48 hours and 30 days, with reductions maintained at 90 days and 1 year in all groups. Mean 6-minute walk distance, PROMIS-PF-6b, and PEmb-QOL scores improved over the course of 1 year in all groups.
Conclusions
Accelerated lower-dose tPA regimens for ultrasound-facilitated, catheter-directed fibrinolysis resulted in sustained recovery of RV-to-left ventricular diameter ratio and tricuspid annular plane systolic excursion and improvements in functional status and quality of life over 1 year. Registration: URL: https://www.ClinicalTrials.gov. Unique Identifier: NCT02396758.



Circ Cardiovasc Interv: 30 Jul 2020; 13:e009012
Piazza G, Sterling KM, Tapson VF, Ouriel K, ... Liu PY, Goldhaber SZ
Circ Cardiovasc Interv: 30 Jul 2020; 13:e009012 | PMID: 32757658
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra-Large Aortic Annuli From the TAVR-LARGE Registry.

Armijo G, Tang GHL, Kooistra N, Ferreira-Neto AN, ... Rodés-Cabau J, Nombela-Franco L
Background
Currently, 2 third-generation transcatheter valves, 29-mm Sapien-3 and 34-mm Evolut-R (ER), are indicated for large sized aortic annuli. We analyzed short and 1-year performance of these valves in patients with large (area ≥575 mm or perimeter ≥85 mm) and extra-large (≥683 mm or ≥94.2 mm) aortic annuli undergoing transcatheter aortic valve replacement.
Methods
A total of 833 patients across 12 centers with symptomatic aortic stenosis and large aortic annuli underwent transcatheter aortic valve replacement with 29-mm Sapien-3 (n=640) or 34-mm ER (n=193). Clinical, anatomic, and procedural characteristics were collected, and Valve Academic Research Consortium-2 outcomes were reported.
Results
Median aortic annulus area and perimeter were 617 mm (591-657) and 89.1 mm (87.0-92.1), respectively (704 mm [689-743] and 96.0 mm [94.5-97.9] in the subgroup of 124 patients with extra-large annuli). Overall device success was 94.3% (Sapien-3, 95.8% and ER, 89.3%; =0.001), with a higher rate of significant paravalvular leak (=0.004), second valve implantation (=0.013), and valve embolization (=0.009) in the ER group. Thirty-day and 1-year mortality was 2.4% and 9.2%, respectively, without differences between groups. Valve hemodynamics were excellent (mean gradient, 8.8±3.6 mm Hg; 3.3% rate of moderate-severe paravalvular leak) in the extra-large annulus, without differences compared with the large annulus group.
Conclusions
In patients with large and extra-large aortic annuli, transcatheter aortic valve replacement using 29-mm Sapien-3 and 34-mm ER is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing transcatheter aortic valve replacement.



Circ Cardiovasc Interv: 30 Jul 2020; 13:e009047
Armijo G, Tang GHL, Kooistra N, Ferreira-Neto AN, ... Rodés-Cabau J, Nombela-Franco L
Circ Cardiovasc Interv: 30 Jul 2020; 13:e009047 | PMID: 32757657
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Short-Term Oral Anticoagulation Versus Antiplatelet Therapy Following Transcatheter Left Atrial Appendage Closure.

Asmarats L, O\'Hara G, Champagne J, Paradis JM, ... Côté M, Rodés-Cabau J
Background
The impact of antithrombotic therapy on coagulation system activation after left atrial appendage closure (LAAC) remains unknown. This study sought to compare changes in coagulation markers associated with short-term oral anticoagulation (OAC) versus antiplatelet therapy (APT) following LAAC.
Methods
Prospective study including 78 atrial fibrillation patients undergoing LAAC with the Watchman device. F1+2 (prothrombin fragment 1+2) and TAT (thrombin-antithrombin III) were assessed immediately before the procedure, and at 7, 30, and 180 days after LAAC.
Results
Forty-eight patients were discharged on APT (dual: 31, single: 17) and 30 on OAC (direct anticoagulants: 26, vitamin K antagonists: 4), with no differences in baseline-procedural characteristics between groups except for higher spontaneous echocardiography contrast in the OAC group. OAC significantly reduced coagulation activation within 7 days post-LAAC compared with APT (23% [95% CI, 5%-41%] versus 82% [95% CI, 54%-111%] increase for F1+2, =0.007; 52% [95% CI, 15%-89%] versus 183% [95% CI, 118%-248%] increase for TAT, =0.048), with all patients in both groups progressively returning to baseline values at 30 and 180 days. Spontaneous echocardiography contrast pre-LAAC was associated with an enhanced activation of the coagulation system post-LAAC (144 [48-192] versus 52 [24-111] nmol/L, =0.062 for F1+2; 299 [254-390] versus 78 [19-240] ng/mL, =0.002 for TAT). Device-related thrombosis occurred in 5 patients (6.4%), and all of them were receiving APT at the time of transesophageal echocardiography (10.2% versus 0% if OAC at the time of transesophageal echocardiography, =0.151). Patients with device thrombosis exhibited a greater coagulation activation 7 days post-LAAC (=0.038 and =0.108 for F1+2 and TAT, respectively).
Conclusions
OAC (versus APT) was associated with a significant attenuation of coagulation system activation post-LAAC. Spontaneous echocardiography contrast pre-LAAC associated with enhanced coagulation activation post-LAAC, which in turn increased the risk of device thrombosis. These results highlight the urgent need for randomized trials comparing OAC versus APT post-LAAC.



Circ Cardiovasc Interv: 30 Jul 2020; 13:e009039
Asmarats L, O'Hara G, Champagne J, Paradis JM, ... Côté M, Rodés-Cabau J
Circ Cardiovasc Interv: 30 Jul 2020; 13:e009039 | PMID: 32772571
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Management of Aortic Stenosis in Patients With End-Stage Renal Disease on Hemodialysis.

Mentias A, Desai MY, Saad M, Horwitz PA, ... Kapadia S, Vaughan-Sarrazin M
Background
Patients with end-stage renal disease on hemodialysis (ESRD-HD) and aortic stenosis have poor prognosis. The role of transcatheter aortic valve replacement (TAVR) in this high-risk population is debated.
Methods
We compared the outcomes among ESRD-HD Medicare beneficiaries who were managed with TAVR, surgical AVR (SAVR), or conservative management for aortic stenosis between 2015 and 2017, using overlap propensity score weighting analysis to control for differences in treatment assignment. The primary outcome was all-cause mortality and was compared between treatment groups as well as to age-sex matched mortality for ESRD-HD in the US population. Secondary outcomes included trend of heart failure hospitalizations.
Results
A total of 8107 ESRD-HD patients with aortic stenosis were included, 4130 (50%) underwent TAVR, 2565 (31.6%) underwent SAVR, and 1412 (17.4%) were managed conservatively. TAVR patients had more comorbidities and higher frailty compared with the other 2 groups. Thirty-day mortality was lower with TAVR compared with SAVR (4.6% versus 12.8%, <0.01). After a median follow-up of 465 days (interquartile range, 261-759), on overlap propensity score weighting analysis, there was no difference in mortality between TAVR and SAVR (adjusted hazard ratio, 1.02 [95% CI, 0.91-1.15], =0.7), and mortality was lower with TAVR compared with conservative management (adjusted hazard ratio, 0.53 [95% CI, 0.47-0.60], <0.001). Standardized mortality ratios with TAVR, SAVR, and conservative management compared with age-sex matched ESRD-HD US population were 1.24, 1.27, and 1.83, respectively. The rate of heart failure admissions declined after TAVR (incidence rate ratio, 0.55 [95% CI, 0.48-0.62], <0.001) and SAVR (incidence rate ratio, 0.76 [95% CI, 0.65-0.88], <0.001).
Conclusions
In ESRD-HD patients with aortic stenosis, mortality was lower in the short-term with TAVR compared with SAVR but comparable in the mid-term. AVR is associated with an improvement in survival and reduction in heart failure hospitalizations compared with conservative management.



Circ Cardiovasc Interv: 30 Jul 2020; 13:e009252
Mentias A, Desai MY, Saad M, Horwitz PA, ... Kapadia S, Vaughan-Sarrazin M
Circ Cardiovasc Interv: 30 Jul 2020; 13:e009252 | PMID: 32772570
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Clinical Characteristics and Outcomes From Percutaneous Coronary Intervention of Last Remaining Coronary Artery: An Analysis From the British Cardiovascular Intervention Society Database.

Shoaib A, Rashid M, Kontopantelis E, Sharp A, ... Mamas MA,
Background
Patients with complex high-risk coronary anatomy, such as those with a last remaining patent vessel (LRPV), are increasingly revascularized with percutaneous coronary intervention (PCI) in contemporary practice. There are limited data on the outcomes of these high-risk procedures.
Methods
We analyzed a large longitudinal PCI cohort (2007-2014, n=501 841) from the British Cardiovascular Intervention Society database. Clinical, demographic, procedural, and outcome data were analyzed by dividing patients into 2 groups; LRPV group (n=2432) and all other PCI groups (n=506 691).
Results
Patients in the LRPV PCI group were older, had more comorbidities, and higher prevalence of moderate-severe left ventricular systolic dysfunction. Mortality was higher in the LRPV PCI group during hospital admission (12 % versus 1.5 %, <0.001), at 30 days (15% versus 2%, <0.001), and at one-year (24% versus 5%, <0.001). In a propensity score matching analysis the adjusted risk of mortality during index admission (odds ratio, 2.05 [95% CI, 1.65-2.44], <0.001), at 30 days (odds ratio, 2.13 [95% CI, 1.78-2.5], <0.001), at 1 year (odds ratio, 1.81 [95% CI, 1.59-2.03], <0.001), and in-hospital major adverse cardiovascular events (odds ratio, 1.8 [95% CI, 1.42-2.19], <0.001) were higher in LRPV PCI group as compared to control group. In sensitivity analyses, similar clinical outcomes were observed irrespective of which major epicardial coronary artery was treated.
Conclusions
In this contemporary cohort, patients who had PCI to their LRPV had a higher-risk profile and more adverse clinical outcomes, irrespective of the vessel treated.



Circ Cardiovasc Interv: 30 Aug 2020; 13:e009049
Shoaib A, Rashid M, Kontopantelis E, Sharp A, ... Mamas MA,
Circ Cardiovasc Interv: 30 Aug 2020; 13:e009049 | PMID: 32873051
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Association of Operator and Hospital Experience With Procedural Success Rates and Outcomes in Patients Undergoing Percutaneous Coronary Interventions for Chronic Total Occlusions: Insights From the Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

Zein R, Seth M, Othman H, Rosman HS, ... Mehta RH, Gurm HS
Background
An inverse relationship has been described between procedural success and outcomes of all major cardiovascular procedures. However, this relationship has not been studied for percutaneous coronary intervention (PCI) of chronic total occlusion (CTO).
Methods
We analyzed the data on patients enrolled in Blue Cross Blue Shield of Michigan Cardiovascular Consortium registry in Michigan (January 1, 2010 to March 31, 2018) to evaluate the association of operator and hospital experience with procedural success and outcomes of patients undergoing CTO-PCI. CTO-PCI was defined as intervention of a 100% occluded coronary artery presumed to be ≥3 months old.
Results
Among 210 172 patients enrolled in the registry, 7389 (3.5%) CTO-PCIs were attempted with a success rate of 53%. CTO-PCI success increased with operator experience (45% and 65% in the lowest and highest experience tertiles) and was the highest for highly experienced operators at higher experience centers and the lowest for inexperienced operators at low experience hospitals. Multivariable logistic regression models (with spline transformed prior operator and institutional experience) demonstrated a positive relationship between prior operator and site experience and procedural success rates (likelihood ratio test=141.12, df=15, <0.001) but no relationship between operator and site experience and major adverse cardiac event (likelihood ratio test=19.12, df=15, =0.208).
Conclusions
Operator and hospital CTO-PCI experiences were directly related to procedural success but were not related to major adverse cardiac event among patients undergoing CTO-PCIs. Inexperienced operators at high experience centers had significantly higher success but not major adverse cardiac event rates compared with inexperienced operators at low experience centers. These data suggested that CTO-PCI safety and success could potentially be improved by selective referral of these procedures to experienced operators working at highly experienced centers.



Circ Cardiovasc Interv: 30 Jul 2020; 13:e008863
Zein R, Seth M, Othman H, Rosman HS, ... Mehta RH, Gurm HS
Circ Cardiovasc Interv: 30 Jul 2020; 13:e008863 | PMID: 32791954
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Discharge Prescription Patterns for Antiplatelet Therapy Following Lower Extremity Peripheral Vascular Intervention.

Singh N, Ding L, Magee GA, Shavelle DM, Kashyap VS, Garg PK
Background
Despite current guidelines suggesting a benefit for dual antiplatelet therapy (DAPT) following peripheral vascular intervention (PVI), there are limited data on antiplatelet prescribing patterns post-procedure. We attempted to determine variables associated with DAPT prescription following lower extremity PVI.
Methods
Retrospective analysis of patients undergoing lower extremity PVI in the Vascular Quality Initiative (2017-2018) was performed. Participants not on anticoagulation or DAPT before the procedure were considered for the final analysis. Postdischarge antiplatelet therapy regimen rates were determined (none, aspirin only, P2Y12 inhibitor only, and DAPT). Multivariate logistic regression was performed to determine variables associated with DAPT initiation compared with those discharged on single-agent or no antiplatelet therapy.
Results
A total of 16 597 procedures were included for analysis, with 49% initiated on DAPT post-PVI. Male sex (odds ratio [OR], 1.12 [95% CI, 1.05-1.20]), smoking (OR, 1.20 [95% CI, 1.09-1.32]), and coronary artery disease (OR, 1.19 [95% CI, 1.11-1.27]) were associated with an increased likelihood of post-PVI DAPT prescription. Procedures requiring multiple types of interventions (OR, 1.28 [95% CI, 1.15-1.42]), stent placement (OR, 1.16 [95% CI, 1.06-1.27]), and with complications (OR, 1.31 [95% CI, 1.14-1.52]) were also positively associated with DAPT prescription.
Conclusions
In patients not already receiving anticoagulation or on DAPT at the time of lower extremity PVI, prescription of DAPT following intervention is ≈50%. Multiple factors were associated with the decision for DAPT versus single antiplatelet therapy, and further study is required to understand how this affects postintervention adverse limb and cardiovascular events.



Circ Cardiovasc Interv: 30 Jul 2020; 13:e008791
Singh N, Ding L, Magee GA, Shavelle DM, Kashyap VS, Garg PK
Circ Cardiovasc Interv: 30 Jul 2020; 13:e008791 | PMID: 32791948
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Impact of Bleeding and Myocardial Infarction on Mortality in All-Comer Patients Undergoing Percutaneous Coronary Intervention.

Hara H, Takahashi K, Kogame N, Tomaniak M, ... Onuma Y, Serruys PW
Background
Bleeding and myocardial infarction (MI) after percutaneous coronary intervention are independent risk factors for mortality. This study aimed to investigate the association of all-cause mortality after percutaneous coronary intervention with site-reported bleeding and MI, when considered as individual, repeated, or combined events.
Methods
We used the data from the GLOBAL LEADERS trial (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-Platelet Therapy After Stent Implantation), an all-comers trial of 15 968 patients undergoing percutaneous coronary intervention. Bleeding was defined as Bleeding Academic Research Consortium (BARC) 2, 3, or 5, whereas MI included periprocedural and spontaneous MIs according to the Third Universal Definition.
Results
At 2-year follow-up, 1061 and 498 patients (6.64% and 3.12%) experienced bleeding and MI, respectively. Patients with a bleeding event had a 10.8% mortality (hazard ratio [HR], 5.97 [95% CI, 4.76-7.49]; <0.001), and the mortality of patients with an MI was 10.4% (HR, 5.06 [95% CI, 3.72-6.90]; <0.001), whereas the overall mortality was 2.99%. Albeit reduced over time, MI and even minor BARC 2 bleeding significantly influenced mortality beyond 1 year after adverse events (HR of MI, 2.32 [95% CI, 1.18-4.55]; =0.014, and HR of BARC 2 bleeding, 1.79 [95% CI, 1.02-3.15]; =0.044). The mortality rates in patients with repetitive bleeding, repetitive MI, and both bleeding and MI were 16.1%, 19.2%, and 19.0%, and their HRs for 2-year mortality were 8.58 (95% CI, 5.63-13.09; <0.001), 5.57 (95% CI, 2.53-12.25; <0.001), and 6.60 (95% CI, 3.44-12.65; <0.001), respectively. De-escalation of antiplatelet therapy at the time of BARC 3 bleeding was associated with a lower subsequent bleeding or MI rate, compared with continuation of antiplatelet therapy (HR, 0.32 [95% CI, 0.11-0.92]; =0.034).
Conclusions
The fatal impact of bleeding and MI persisted beyond one year. Additional bleeding or MIs resulted in a poorer prognosis. De-escalation of antiplatelet therapy at the time of BARC 3 bleeding could have a major safety merit. These results emphasize the importance of considering the net clinical benefit including ischemic and bleeding events. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01813435.



Circ Cardiovasc Interv: 30 Aug 2020; 13:e009177
Hara H, Takahashi K, Kogame N, Tomaniak M, ... Onuma Y, Serruys PW
Circ Cardiovasc Interv: 30 Aug 2020; 13:e009177 | PMID: 32838554
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Novel Panna Guide Wire Facilitates Percutaneous and Nonfluoroscopic Procedure for Atrial Septal Defect Closure: A Randomized Controlled Trial.

Kong P, Zhao G, Zhang Z, Zhang W, ... Hu S, Pan X
Background
Echo-guided percutaneous procedures have been reported reliable and advantageous. However, the learning curve is difficult for junior doctors. We aimed to evaluate the safety and efficacy of a novel guidewire (Panna wire) in percutaneous atrial septal defect closure under transthoracic echocardiography guidance only.
Methods
The Panna wire is designed for echo-guide procedure with a retractable spindle-shaped tip. A multicenter, randomized, controlled trial was conducted to evaluate the safety and efficacy of the Panna wire versus the conventional guidewire for junior doctors with <100 cases experience. The primary outcome was operative success rate. The secondary outcomes were incidence of major adverse events, operation time, time needed to enter the left atrium, number of arrhythmia episodes, number of misguidance to tricuspid valve, and incidence of peripheral vascular complications.
Results
Between July 2018 and September 2019, 100 patients with atrial septal defect were randomized to either the Panna wire group (n=52) or the conventional wire group (n=48) at 3 centers. The baseline clinical characteristics were similarly distributed. The operative success rate (primary outcome) was 100% in the Panna wire group versus 68.75% in the conventional wire group (<0.001). No major adverse events occurred in either group. Significant differences in favor of the Panna wire group were found in operation time (=0.004), time needed to enter the left atrium (<0.001), number of arrhythmia episodes (<0.001), and number of misguidance to tricuspid valve (=0.005).
Conclusions
The Panna wire is safe and effective and reduces the learning curve in percutaneous atrial septal defect closure under transthoracic echocardiography guidance only. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT04096924.



Circ Cardiovasc Interv: 30 Aug 2020; 13:e009281
Kong P, Zhao G, Zhang Z, Zhang W, ... Hu S, Pan X
Circ Cardiovasc Interv: 30 Aug 2020; 13:e009281 | PMID: 32847382
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Pregnancy-Associated Myocardial Infarction: Prevalence, Causes, and Interventional Management.

Tweet MS, Lewey J, Smilowitz NR, Rose CH, Best PJM

Pregnancy-associated myocardial infarction is a primary contributor to maternal cardiovascular morbidity and mortality. Specific attention to the cause of myocardial infarction, diagnostic evaluation, treatment strategies, and postevent care is necessary when treating women with pregnancy-associated myocardial infarction. This review summarizes the current knowledge, consensus statements, and essential nuances.



Circ Cardiovasc Interv: 31 Jul 2020:CIRCINTERVENTIONS120008687; epub ahead of print
Tweet MS, Lewey J, Smilowitz NR, Rose CH, Best PJM
Circ Cardiovasc Interv: 31 Jul 2020:CIRCINTERVENTIONS120008687; epub ahead of print | PMID: 32862672
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Effects of ON-Hours Versus OFF-Hours Admission on Outcome in Patients With Myocardial Infarction and Cardiogenic Shock: Results From the CULPRIT-SHOCK Trial.

Sag CM, Zeymer U, Ouarrak T, Schneider S, ... Thiele H, Maier LS
Background
The management of patients with acute myocardial infarction complicated by cardiogenic shock is highly complex, and outcomes may depend on the time of hospital admission and subsequent intervention (ie, ON-hours versus OFF-hours). The CULPRIT-SHOCK trial (Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock) demonstrated superior outcome for culprit-lesion-only versus immediate multivessel percutaneous coronary intervention in patients presenting with acute myocardial infarction, multivessel disease, and cardiogenic shock. However, it is unknown whether the time of hospital admission affects the overall outcome of these high-risk patients.
Methods
We analyzed patients from the CULPRIT-SHOCK trial with respect to the time of hospital admission. We divided patients in ON-hours and OFF-hours groups and further stratified them according to their individual revascularization strategy. Outcome measures consisted of a composite end point of death or renal-replacement therapy within 30 days and mortality within 1 year.
Results
Out of 686 patients randomized in the CULPRIT-SHOCK trial, 444 patients (64.7%) presented during ON-hours, whereas 242 patients (35.3%) presented during OFF-hours. Death or renal-replacement therapy at 30 days occurred to a similar extent in patients admitted during ON-hours (51.0%) and OFF-hours (50.0%; =0.80). Similarly, 1-year mortality was not affected by the time of hospital admission (54.4% ON-hours versus 51.7% OFF-hours, =0.49). Regardless of admission time, patients had a benefit from culprit-lesion-only as compared to immediate multivessel percutaneous coronary intervention. The composite end point at 30 days occurred in 45.1% versus 57.6% of patients admitted ON-hours and in 47.7% versus 51.9% of patients admitted OFF-hours (=0.29). Death within 1 year occurred in 49.4% versus 60.0% of patients admitted during ON-hours and in 51.4% versus 51.9% of patients admitted OFF-hours (=0.20).
Conclusions
Among patients with myocardial infarction and cardiogenic shock, the risk of death or renal-replacement therapy at 30 days, and mortality at 1 year did not differ significantly according to the time of hospital admission. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01927549.



Circ Cardiovasc Interv: 30 Aug 2020; 13:e009562
Sag CM, Zeymer U, Ouarrak T, Schneider S, ... Thiele H, Maier LS
Circ Cardiovasc Interv: 30 Aug 2020; 13:e009562 | PMID: 32883104
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Association Between 90-Minute Door-to-Balloon Time, Selective Exclusion of Myocardial Infarction Cases, and Access Site Choice: Insights From the Cardiac Care Outcomes Assessment Program (COAP) in Washington State.

Nathan AS, Raman S, Yang N, Painter I, ... Giri J, Fanaroff AC
Background
For patients presenting with ST-segment-elevation myocardial infarction, national quality initiatives monitor hospitals\' proportion of cases with door-to-balloon (D2B) time under 90 minutes. Hospitals are allowed to exclude patients from reporting and may modify behavior to improve performance. We sought to identify whether there is a discontinuity in the number of cases included in the D2B time metric at 90 minutes and whether operators were increasingly likely to pursue femoral access in patients with less time to meet the 90-minute quality metric.
Methods
Adult patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention from 2011 to 2018 were identified from the Cardiac Care Outcomes Assessment Program, a quality improvement registry in Washington state. We used the regression discontinuity framework to test for discontinuity at 90 minutes among the included cases. We defined a novel variable, remaining D2B as 90 minutes minus the time between hospital arrival and catheterization laboratory arrival. We estimated multivariable logistic regression models to assess the relationship between remaining D2B time and access site.
Results
A total of 19 348 patients underwent primary percutaneous coronary intervention and were included in the analysis. Overall, 7436 (38.4%) were excluded from the metric. There appeared to be a visual discontinuity in included cases around 90 minutes; however, local quadratic regression around the 90-minute cutoff did not reveal evidence of a significant discontinuity (=0.66). Multivariable analysis showed no significant relationship between remaining D2B time and the odds of undergoing femoral access (=0.73).
Conclusions
Among patients undergoing percutaneous coronary intervention for ST-segment-elevation myocardial infarction, we did not find evidence of a statistically significant discontinuity in the frequency of included cases around 90 minutes or an increased preference for femoral access correlated with decreasing time to meet the 90-minute D2B time quality metric. Together, these findings indicate no evidence of widespread inappropriate methods to improve performance on D2B time metrics.



Circ Cardiovasc Interv: 30 Aug 2020; 13:e009179
Nathan AS, Raman S, Yang N, Painter I, ... Giri J, Fanaroff AC
Circ Cardiovasc Interv: 30 Aug 2020; 13:e009179 | PMID: 32883103
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Impact of Coronary Lesion Stability on the Benefit of Emergent Percutaneous Coronary Intervention After Sudden Cardiac Arrest.

Pechmajou L, Marijon E, Varenne O, Dumas F, ... Karam N,
Background
Conflicting data exist regarding the benefit of urgent coronary angiogram and percutaneous coronary intervention (PCI) after sudden cardiac arrest, particularly in the absence of ST-segment elevation. We hypothesized that the type of lesions treated (stable versus unstable) influences the benefit derived from PCI.
Methods
Data were taken between May 2011 and 2014 from a prospective registry enrolling all sudden cardiac arrest in Paris and suburbs (6.7 million inhabitants). Patients undergoing emergent coronary angiogram were included. Decision to perform PCI was left to the discretion of local teams. We assessed the impact of emergent PCI on survival at discharge according to whether the treated lesion was angiographically unstable or stable, and we investigated the predictive factors for unstable coronary lesions.
Results
Among 9265 sudden cardiac arrests occurring during the study period, 1078 underwent emergent coronary angiogram (median age: 59.6 years, 78.3% males): 463 (42.9%) had an unstable lesion, 253 (23.5%) only stable lesions, and 362 (33.6%) no significant lesions. Emergent PCI was performed in 478 patients (91.4% of unstable and 21.7% of stable lesions). At discharge, PCI of unstable lesions was associated with twice-higher survival rate compared with untreated unstable lesions (47.9% versus 25.6%, =0.013), while stable lesions PCI did not improve survival (25.5% versus 26.3%, =1.00). After adjustment, PCI of unstable coronary lesions was independently associated with improved survival (odds ratio, 2.09 [95% CI, 1.42-3.09], <0.001), contrary to PCI of stable lesions (odds ratio, 0.92 [95% CI. 0.44-1.87], =0.824). Angina, initial shockable rhythm, ST-segment elevation, and absence of known coronary artery disease were independent predictors of unstable lesions.
Conclusions
Emergent PCI of unstable lesions is associated with improved survival after sudden cardiac arrest, contrary to PCI of stable lesions. Accordingly, early PCI should only be performed in patients with unstable lesions. Four factors (chest pain, ST-elevation, absence of coronary artery disease history, and shockable initial rhythm) could help identify patients with unstable lesions who would, therefore, benefit from emergent coronary angiogram.



Circ Cardiovasc Interv: 30 Aug 2020; 13:e009181
Pechmajou L, Marijon E, Varenne O, Dumas F, ... Karam N,
Circ Cardiovasc Interv: 30 Aug 2020; 13:e009181 | PMID: 32895006
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Prognostic Impact of Residual Anatomic Disease Burden After Functionally Complete Revascularization.

Lee JM, Hwang D, Choi KH, Lee HJ, ... Kakuta T, Koo BK
Background
Prognostic impact of residual anatomic disease burden after functionally complete percutaneous coronary intervention (PCI), defined by post-PCI fractional flow reserve (FFR) >0.80 would be a clinically relevant question. The current study evaluated clinical outcomes at 2 years according to residual Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) score (RSS) in patients who underwent functionally complete revascularization.
Methods
A total of 1910 patients (2095 revascularized vessels) with post-PCI FFR >0.80 were selected from the International Post-PCI FFR Registry. RSS was defined as the SYNTAX score recalculated after PCI, SYNTAX revascularization index was calculated as 100×(1-RSS/pre-PCI SYNTAX score), and post-PCI FFR was measured after completion of PCI. The primary outcome was target vessel failure (TVF; a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization) at 2 years, and risk of TVF was compared according to tertile classification of RSS (0, 1-5, and >5) and post-PCI FFR (≥0.94, 0.87-0.93, and ≤0.86).
Results
After PCI, SYNTAX score was changed from 10.0 (Q1-Q3, 7.0-16.0) to 0.0 (Q1-Q3, 0.0-5.0) and FFR changed from 0.70±0.12 to 0.90±0.05. TVF at 2 years occurred in 4.9%, and patients with TVF showed higher pre-PCI SYNTAX score and lower post-PCI FFR than those without. However, there were no significant differences in SYNTAX revascularization index and RSS. The risk of TVF was not different according to tertile of RSS (log-rank =0.851). Conversely, risk of TVF was different according to tertile of post-PCI FFR (log-rank =0.009). Multivariable model showed the risk of TVF was significantly associated with post-PCI FFR (hazard ratio, 1.091 [95% CI, 1.032-1.153]; =0.002) but not with RSS (hazard ratio, 0.969 [95% CI, 0.898-1.045]; =0.417).
Conclusions
Among patients who underwent functionally complete revascularization, residual anatomic disease burden assessed by RSS was not related with occurrence of TVF at 2 years. These results support the importance of functionally complete revascularization rather than angiographic complete revascularization. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT04012281.



Circ Cardiovasc Interv: 30 Aug 2020; 13:e009232
Lee JM, Hwang D, Choi KH, Lee HJ, ... Kakuta T, Koo BK
Circ Cardiovasc Interv: 30 Aug 2020; 13:e009232 | PMID: 32895005
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Comparison of Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Stents and Thin, Durable-Polymer Everolimus-Eluting Stents in Calcified or Small Vessel Lesions.

Dan K, Garcia-Garcia HM, Kolm P, Windecker S, ... Kandzari DE, Waksman R
Background
The ultrathin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) demonstrated comparable performance to durable-polymer everolimus-eluting stent (DP-EES) in randomized controlled trials. The purpose of this study was to evaluate the performance of a BP-SES compared with a DP-EES in calcified or small vessel lesions, which represent higher risk of restenosis.
Methods
From the pooled BIOFLOW (BIOFLOW-II, IV, and V; BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions ) randomized controlled trials, a total of 1553 BP-SES and 784 DP-EES patients with valid 1-year follow-up data were available. Coronary lesions were assessed for the presence of moderate-to-severe calcification or small vessels (reference vessel diameter, ≤2.75 mm) by core laboratory analysis. One-year clinical outcomes were assessed with or without the lesion subsets between BP-SES and DP-EES.
Results
Baseline characteristics were similar between the groups. Among patients with small vessel disease, target lesion failure (8.0% versus 12.4%; <0.01) and target vessel myocardial infarction (4.2% versus 7.6%; <0.01) were significantly lower in BP-SES than in DP-EES. No difference in the outcome between the stents was shown in patients with non-small vessel lesions. In patients with calcified lesions, target lesion failure (12.2% versus 6.9%; =0.056), and cardiac death (1.9% versus 0.3%; =0.081) were numerically higher in DP-EES than in BP-SES. In the noncalcified lesion analysis, target vessel myocardial infarction in DP-EES was significantly higher than in BP-SES. Stent thrombosis was similar between the stents in both lesion groups.
Conclusions
Among patients with more complex disease representing a higher risk of target lesion failure, the effectiveness of an ultrathin-strut BP-SES compared with a thin-strut DP-EES was maintained through 1 year. Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01356888, NCT01939249, NCT02389946.



Circ Cardiovasc Interv: 30 Aug 2020; 13:e009189
Dan K, Garcia-Garcia HM, Kolm P, Windecker S, ... Kandzari DE, Waksman R
Circ Cardiovasc Interv: 30 Aug 2020; 13:e009189 | PMID: 32895004
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Calcific Plaque Modification by Acoustic Shockwaves: Intravascular Lithotripsy in Coronary Interventions.

Karimi Galougahi K, Patel S, Shlofmitz RA, Maehara A, ... Stone GW, Ali ZA

Constituting a significant proportion of lesions treated with transcatheter interventions in the coronary arteries, moderate to severe calcification portends lower procedural success rates, increased periprocedural major adverse events, and unfavorable long-term clinical outcomes compared to non-calcific plaques. Adapted from the lithotripsy technology for treatment of nephrolithiasis, intravascular lithotripsy (IVL) is a new technique for treatment of severely calcific lesions that uses acoustic shock waves in a balloon-based system to induce fracture in the calcium deposits in order to facilitate luminal gain and stent expansion. Herein, we summarize the physics and characteristics of the currently available IVL system (Shockwave Medical, Santa Clara, CA), the clinical data on IVL use in the coronary arteries, and future directions for adoption of the technique in percutaneous coronary intervention.



Circ Cardiovasc Interv: 09 Sep 2020; epub ahead of print
Karimi Galougahi K, Patel S, Shlofmitz RA, Maehara A, ... Stone GW, Ali ZA
Circ Cardiovasc Interv: 09 Sep 2020; epub ahead of print | PMID: 32907343
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Use of a Novel Septal Occluder Device for Left Atrial Appendage Closure in Patients With Postsurgical and Postlariat Leaks or Anatomies Unsuitable for Conventional Percutaneous Occlusion.

Della Rocca DG, Horton RP, Tarantino N, Van Niekerk CJ, ... Di Biase L, Natale A
Background
Interventional therapies aiming at excluding the left atrial appendage (LAA) from systemic circulation have been established as a valid alternative to oral anticoagulation in patients at high thromboembolic risk. However, their efficacy on stroke prophylaxis may be compromised owing to incomplete LAA closure. Additionally, the need for an alternative thromboembolic prevention may remain unmet in patients with contraindications to oral anticoagulation whose appendage anatomy is unsuitable for some conventional devices commercially available. We aimed at evaluating the feasibility of LAA closure with the novel Gore Cardioform Septal Occluder in patients with incomplete appendage ligation or anatomic features which do not meet the manufacturer\'s requirements for Watchman deployment.
Methods
Twenty-one consecutive patients (mean age: 72±6 years; 85.7% males; CHADS-VASc: 4.5±1.4; HAS-BLED: 3.6±1.0) were included. Transesophageal echocardiography was performed within 2 months to assess for residual LAA patency.
Results
Fourteen patients had incomplete LAA closure following surgical (n=6) or Lariat ligation (n=8). In 7 patients with an appendage anatomy unsuitable for Watchman deployment, the mean maximal landing zone size and LAA depth were 14.4±1.3and 18.6±2.8 mm. Successful Cardioform Septal Occluder deployment was achieved in all patients. No peri-procedural complications were documented.Procedure and fluoroscopy times were 46±13 and 14±5 minutes. Follow-up transesophageal echocardiography after 58±9 days revealed complete LAA closure in all patients.
Conclusions
Transcatheter LAA closure via a Cardioform Septal Occluder device might be a valid alternative in patients with residual leaks following failed appendage ligation or whose LAA anatomy does not meet the minimal anatomic criteria to accommodate a Watchman device.



Circ Cardiovasc Interv: 17 Sep 2020:CIRCINTERVENTIONS120009227; epub ahead of print
Della Rocca DG, Horton RP, Tarantino N, Van Niekerk CJ, ... Di Biase L, Natale A
Circ Cardiovasc Interv: 17 Sep 2020:CIRCINTERVENTIONS120009227; epub ahead of print | PMID: 32942913
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Contemporary Review of Antithrombotic Therapy in Peripheral Artery Disease.

Hess CN, Bonaca MP

Patients with peripheral artery disease (PAD) are at heightened risk for ischemic events related to atherothrombosis. Antithrombotic therapies can reduce the risk of atherothrombotic events but increase bleeding. Importantly, there is growing appreciation of the heterogeneity in risk profile and effect of antithrombotic therapies in different populations, including those with PAD. Further, patients with PAD are at risk for not only major adverse cardiovascular events but also major adverse limb events, and the drivers of risk for each are different. Within PAD populations, data from trials may be difficult to interpret due to differences among the studies with regards to patient population, clinical settings, and outcomes examined. The acute setting of peripheral revascularization which involves plaque rupture and endothelial disruption confers very high risk of major adverse limb events early postprocedure. Among patients with chronic PAD for whom the goal of antithrombotic therapy is secondary prevention, concomitant coronary artery disease, particularly with prior myocardial infarction, is associated with greatest risk for major adverse cardiovascular events, while prior peripheral revascularization or amputation is associated with greatest risk for major adverse limb events. Understanding of the potential impact of clinical setting and patient risk profile is important to guide evidence-based decisions regarding antithrombotic therapy in patients with PAD. In this article, we provide a contemporary review of data supporting the use of antithrombotic therapy in PAD, as well as a clinical framework for analysis and translation of these data into practice, highlighting areas in need of further investigation.



Circ Cardiovasc Interv: 06 Oct 2020:CIRCINTERVENTIONS120009584; epub ahead of print
Hess CN, Bonaca MP
Circ Cardiovasc Interv: 06 Oct 2020:CIRCINTERVENTIONS120009584; epub ahead of print | PMID: 33023325
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Use of Natural Language Processing to Improve Identification of Patients With Peripheral Artery Disease.

Weissler EH, Zhang J, Lippmann S, Rusincovitch S, Henao R, Jones WS
Background
Peripheral artery disease (PAD) is underrecognized, undertreated, and understudied: each of these endeavors requires efficient and accurate identification of patients with PAD. Currently, PAD patient identification relies on diagnosis/procedure codes or lists of patients diagnosed or treated by specific providers in specific locations and ways. The goal of this research was to leverage natural language processing to more accurately identify patients with PAD in an electronic health record system compared with a structured data-based approach.
Methods
The clinical notes from a cohort of 6861 patients in our health system whose PAD status had previously been adjudicated were used to train, test, and validate a natural language processing model using 10-fold cross-validation. The performance of this model was described using the area under the receiver operating characteristic and average precision curves; its performance was quantitatively compared with an administrative data-based least absolute shrinkage and selection operator (LASSO) approach using the DeLong test.
Results
The median (SD) of the area under the receiver operating characteristic curve for the natural language processing model was 0.888 (0.009) versus 0.801 (0.017) for the LASSO-based approach alone (DeLong <0.0001). The median (SD) of the area under the precision curve was 0.909 (0.008) versus 0.816 (0.012) for the structured data-based approach. When sensitivity was set at 90%, the precision for LASSO was 65% and the machine learning approach was 74%, while the specificity for LASSO was 41% and for the machine learning approach was 62%.
Conclusions
Using a natural language processing approach in addition to partial cohort preprocessing with a LASSO-based model, we were able to meaningfully improve our ability to identify patients with PAD compared with an approach using structured data alone. This model has potential applications to both interventions targeted at improving patient care as well as efficient, large-scale PAD research.



Circ Cardiovasc Interv: 11 Oct 2020:CIRCINTERVENTIONS120009447; epub ahead of print
Weissler EH, Zhang J, Lippmann S, Rusincovitch S, Henao R, Jones WS
Circ Cardiovasc Interv: 11 Oct 2020:CIRCINTERVENTIONS120009447; epub ahead of print | PMID: 33040585
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Sex Differences in Management and Outcomes of Critical Limb Ischemia in the Medicare Population.

Mentias A, Vaughan-Sarrazin M, Saad M, Girotra S
Background
Evidence about sex differences in management and outcomes of critical limb ischemia (CLI) is conflicting.
Methods
We identified Fee-For-Service Medicare patients within the 5% enhanced sample file who were diagnosed with new incident CLI between 2015 and 2017. For each beneficiary, we identified all hospital admissions, outpatient encounters and procedures, and pharmacy prescriptions. Outcomes included 90-day mortality and major amputation.
Results
Incidence of CLI declined from 2.80 (95% CI, 2.72-2.88) to 2.47 (95% CI, 2.40-2.54) per 1000 person from 2015 to 2017, <0.01. Incidence was lower in women compared with men (2.19 versus 3.11 per 1000) but declined in both groups. Women had a lower prevalence of prescription of any statin (48.4% versus 52.9%, <0.001) or high-intensity statins (15.3% versus 19.8%, <0.01) compared with men. Overall, 90-day revascularization rate was 52%, and women were less likely to undergo revascularization (50.1% versus 53.6%, <0.01) compared with men. Women had a similar unadjusted (9.9% versus 10.3%, =0.5) and adjusted 90-day mortality (adjusted rate ratio, 0.98 [95% CI, 0.85-1.12], =0.7) compared with men. Over the study period, unadjusted 90-day mortality remained unchanged for men (10.4% in 2015 to 9.9% in 2017, =0.3), and women (9.5% in 2015 to 10.6% in 2017, =0.2). Men had higher unadjusted (12.9% versus 8.9%, <0.001) and adjusted risk of 90-day major amputation (adjusted rate ratio, 1.30 [95% CI, 1.14-1.48], <0.001). One-third of patients with CLI underwent major amputation without a diagnostic angiogram or trial of revascularization in the preceding 90 days regardless of the sex.
Conclusions
Women with new incident CLI are less likely to receive statin or undergo revascularization at 90 days compared with men. However, the differences were small. There was no difference in risk of 90-day mortality between both sexes. Graphic Abstract: A graphic abstract is available for this article.



Circ Cardiovasc Interv: 29 Sep 2020; 13:e009459
Mentias A, Vaughan-Sarrazin M, Saad M, Girotra S
Circ Cardiovasc Interv: 29 Sep 2020; 13:e009459 | PMID: 33079598
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
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: 22 Oct 2020:CIRCINTERVENTIONS120009627; epub ahead of print
McCutcheon K, Vanhaverbeke M, Pauwels R, Dabin J, ... Sinnaeve P, Desmet W
Circ Cardiovasc Interv: 22 Oct 2020:CIRCINTERVENTIONS120009627; epub ahead of print | PMID: 33092401
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:

This program is still in alpha version.