Journal: Circ Cardiovasc Interv

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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
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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
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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
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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
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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
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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
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