Safety and Efficacy of Enoxaparin During Low-Risk Elective Percutaneous Coronary Intervention.

Intravenous unfractionated heparin (UFH) is the most frequently used anticoagulant for percutaneous coronary intervention (PCI). Intravenous enoxaparin, a low-molecular-weight heparin, has superior pharmacokinetic and pharmacodynamic properties compared with UFH. Multiple trials have shown enoxaparin to be safe and effective in PCI. However, there has not been a contemporary study evaluating its safety and efficacy. To assess its efficacy and safety, intravenous enoxaparin during PCI through radial artery access was evaluated in PCI patients from January 2015 to December 2019. Outcomes included procedural success, all-cause mortality, ischemic complications, and bleeding complications from the time of the procedure until hospital discharge. A total of 1019 consecutive eligible patients were identified. Median age was 63 years, and 70% were men. The indication for PCI was stable and unstable angina in two-thirds of cases (77%). Few patients had myocardial infarction (MI) (2.2%) as the indication for intervention. The procedure was successful in 98.2% of cases. There were no deaths. Procedural MI occurred in 0.3% of patients. Acute stent thrombosis occurred in 0.4%. Urgent revascularization and stroke occurred in 0.1% each. Small wrist hematomas occurred in 0.3% and all were managed conservatively. There was one radial artery pseudoaneurysm. There were no cases of major bleeding. In conclusion, this single-center study showed that intravenous enoxaparin is a reasonable alternative anticoagulant for use in low-risk and elective non-MI PCI through radial artery access.

Real-World Outcomes of Fourth-Generation Mitral Transcatheter Repair: 30-Day Results From EXPAND G4.

BACKGROUND: The fourth-generation MitraClip G4 System builds on the previous NTR/XTR system with additional wider clip sizes (NTW and XTW), an independent grasping feature, and an improved clip deployment sequence. OBJECTIVES: The primary objective of this study was to assess the safety and performance of the MitraClip G4 System within a contemporary real-world setting. METHODS: EXPAND G4 is a prospective, multicenter, international, single-arm, postapproval study that enrolled patients with primary (degenerative) mitral regurgitation (MR) and secondary (functional) MR at 60 centers. Follow-up of the full cohort has been conducted through 30 days. Echocardiograms were analyzed by an echocardiography core laboratory. Study outcomes included MR severity, functional capacity measured by NYHA functional class, quality of life measured using the Kansas City Cardiomyopathy Questionnaire, major adverse event rates, and all-cause mortality. RESULTS: In EXPAND G4, 1,141 subjects with primary MR and secondary MR were treated from March 2021 to February 2022. Implantation and acute procedural success rates were 98.0% and 96.2%, respectively, with a mean of 1.4 ± 0.6 clips implanted per subject. MR was significantly reduced at 30 days compared with baseline (98% achieved MR ≤ 2+, and 91% achieved MR ≤ 1+; P < 0.0001). Functional capacity and quality of life were substantially improved, with 83% of patients achieving NYHA functional class I or II. Likewise, an 18-point improvement was observed in Kansas City Cardiomyopathy Questionnaire summary scores compared with baseline. The composite major adverse event rate was 2.7%, and the all-cause death rate was 1.3% at 30 days. CONCLUSIONS: This study demonstrates for the first time the effectiveness and safety of MitraClip G4 System at 30 days in a cohort of >1,000 patients with MR in a contemporary, real-world setting.

1-Year Outcomes With Fourth-Generation Mitral Valve Transcatheter Edge-to-Edge Repair From the EXPAND G4 Study.

BACKGROUND: The fourth-generation mitral transcatheter edge-to-edge repair (M-TEER) device introduced an improved clip deployment sequence, independent leaflet grasping, and 2 wider clip sizes to tailor the treatment of patients with mitral regurgitation (MR) for a broad range of anatomies. The 30-day safety and effectiveness of the fourth-generation M-TEER device were previously demonstrated. OBJECTIVES: The aim of this study was to evaluate 1-year outcomes in a contemporary, real-world cohort of subjects treated with the MitraClip G4 system. METHODS: EXPAND G4 is an ongoing prospective, multicenter, international, single-arm study that enrolled subjects with primary and secondary MR. One-year outcomes included MR severity (echocardiographic core laboratory assessed), heart failure hospitalization, all-cause mortality, functional capacity (NYHA functional class), and quality of life (Kansas City Cardiomyopathy Questionnaire). RESULTS: A total of 1,164 subjects underwent M-TEER from 2020 to 2022. At 1 year, there was a durable reduction in MR to mild or less in 92.6% and to none or trace in 44.2% (P < 0.0001 vs baseline). Few subjects had major adverse events through 1 year (<2% for myocardial infarction, surgical reintervention, or single-leaflet device attachment). The 1-year Kaplan-Meier estimates for all-cause mortality and heart failure hospitalization were 12.3% and 16.9%. Significant improvements in functional capacity (NYHA functional class I or II in 82%; P < 0.0001 vs baseline) and quality of life (18.5-point Kansas City Cardiomyopathy Questionnaire overall summary score improvement; P < 0.0001) were observed. CONCLUSIONS: M-TEER with the fourth-generation M-TEER device was safe and effective at 1 year, with durable reductions in MR severity to ≤1+ in more than 90% of patients and concomitant improvements in functional status and quality of life.

Expanding the Spectrum of TEER Suitability: Evidence From the EXPAND G4 Post Approval Study.

BACKGROUND: Anatomical and clinical criteria to define mitral transcatheter edge-to-edge repair (TEER) "unsuitability" have been proposed on the basis of a Heart Valve Collaboratory consensus opinion from physician experience with early-generation TEER devices but lacked an evidence-based approach. OBJECTIVES: The aim of this study was to explore the spectrum of TEER suitability using echocardiographic and clinical outcomes from the EXPAND G4 real-world postapproval study. METHODS: EXPAND G4 is a global, prospective, multicenter, single-arm study that enrolled 1,164 subjects with mitral regurgitation (MR) treated with the MitraClip G4 System. Three groups were defined using the Heart Valve Collaboratory TEER unsuitability criteria: 1) risk of stenosis (RoS); 2) risk of inadequate MR reduction (RoIR); and 3) subjects with baseline moderate or less MR (MMR). A TEER-suitable (TS) group was defined by the absence of these characteristics. Endpoints included independent core laboratory-assessed echocardiographic characteristics, procedural outcomes, MR reduction, NYHA functional class, Kansas City Cardiomyopathy Questionnaire score, and major adverse events through 30 days. RESULTS: Subjects in the RoS (n = 56), RoIR (n = 54), MMR (n = 326), and TS (n = 303) groups had high 30-day MR reduction rates (≤1+: RoS 97%, MMR 93%, and TS 91%; ≤2+: RoIR 94%). Thirty-day improvements in functional capacity (NYHA functional class I or II at 30 days vs baseline: RoS 94% vs 29%, RoIR 88% vs 30%, MMR 79% vs 26%, and TS 83% vs 33%) and quality of life (change in Kansas City Cardiomyopathy Questionnaire score: RoS +27 ± 26, RoIR +16 ± 26, MMR +19 ± 26, and TS +19 ± 24) were safely achieved in all groups, with low major adverse events (<3%) and all-cause mortality (RoS 1.8%, RoIR 0%, MMR 1.5%, and TS 1.3%). CONCLUSIONS: Patients previously deemed TEER unsuitable can be safely and effectively treated with the mitral TEER fourth-generation device.

Transradial Endovascular Intervention: Results From the Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention (REACH PVI) Study.

BACKGROUND/PURPOSE: The transradial approach has been proposed as an alternative to traditional transfemoral access for diagnostic and therapeutic purposes in several catheterization procedures. Historically, extended length devices for lower limb endovascular interventions have been limited. The aim of this study was to investigate the acute clinical outcomes of orbital atherectomy (OA) via transradial access (TRA) for the treatment of lower extremity peripheral artery disease (PAD). METHODS/MATERIALS: REACH PVI was a multicenter, prospective, observational study (NCT03943160) including subjects with PAD and target lesion morphology appropriate for OA. All patients were followed post-procedure through the first standard of care follow-up visit. RESULTS: A total of 50 patients were enrolled. In most cases the indication for intervention was disabling claudication (74.0%). Overall, 50 target lesions were treated, 92.0% of lesions were femoropopliteal and 8.0% were infrapopliteal. The average lesion length was 98.3 ± 87.5 mm and 78.0% of the lesions were severely calcified. Balloon angioplasty was performed in 98.0% of target lesions, while a stent was deployed in 16.0%. Treatment success was 98.0%; in only one case the result was sub-optimal (>30% stenosis with stent placement) and a significant dissection was reported. No serious distal embolization, serious thrombus formation or serious acute vessel closure were observed intra- or post-procedurally. CONCLUSIONS: Transradial OA followed by percutaneous transluminal angioplasty for lower extremity PAD is feasible and demonstrates a favorable safety profile. Extended length devices such as the Extended Length Orbital Atherectomy System could further facilitate transradial endovascular procedures by increasing its spectrum of application.

Radial haemostasis is facilitated with a potassium ferrate haemostatic patch: the Statseal with TR Band assessment trial (STAT).

AIMS: Haemostasis is a limiting factor for discharge after uncomplicated transradial procedures. The purpose of this study was to determine whether a potassium ferrate haemostatic patch (PFHP) could serve as an adjunct to the air-bladder TR Band (TRB) to facilitate implementation of a rapid deflation protocol. METHODS AND RESULTS: This was a prospective multicentre randomised controlled trial comparing radial haemostatic protocols. Deflation of the TRB was attempted at 40 minutes with PFHP and at 120 minutes without the PFHP. The primary outcome was time to full deflation of the TRB with haemostasis. At four US sites, 180 patients were enrolled after receiving a minimum of 5,000 units of unfractionated heparin or bivalirudin. Interventions comprised 30% of procedures. Successful TRB deflation occurred at 43±14 minutes with PFHP and 160±43 minutes without PFHP (p<0.001). Minor haematomas occurred in nine (10.3%) of the TRB patients and 16 (17.2%) of the PFHP patients (p=0.20). Radial artery occlusion occurred in 2% of patients in the PFHP group (p=NS). Outpatients randomised to PFHP were discharged 51±83.5 minutes earlier than control. CONCLUSIONS: The PFHP haemostatic patch facilitated early deflation of the TRB with a non-significant increase in forearm haematomas. Use of the PFHP may improve patient throughput and allow earlier discharge following transradial procedures.

Same versus next day discharge after elective transradial PCI: The RAdial SAme Day DischArge after PCI trial. (The RASADDA-PCI trial).

BACKGROUND AND PURPOSE: Transradial percutaneous coronary intervention (TR-PCI) has been increasingly popular over the last decade in the US. Previous studies have shown that same-day (SD) discharge after elective PCI is as safe as overnight (ON) observation. Our study was performed to assess the clinical and financial impact of early discharge in patients undergoing TR-PCI. METHODS: This is a single center registry of patients undergoing elective TR-PCI. Timing of discharge was determined by the treating physician. (Groups: Same Day Discharge -SD-; Overnight Stay -ON-). Demographic data, procedural characteristics and adverse outcomes were recorded. Outcomes included 30 day-MACE and procedure- related complications, as well as total operative costs in patients from both groups. Propensity score matching for patient demographics, coronary symptoms and procedure indicators was used to compare both groups. RESULTS: The entire cohort included 852 patients (429 in SD group and 423 in ON group) and the propensity score matched groups of 245 patients in the SD group and 245 patients in the ON group. The two groups had no significant baseline clinical differences, and had similar clinical outcomes. Specifically, no significant difference was noted in procedural complications (3.7% vs 2.5%, p = 0.43), re-hospitalization (4.1% vs 4.1%, p = 0.92), re-intervention (2.5% vs 2.1%, p = 0.77), myocardial infarction (0% vs 0.08%, p = 0.15), stroke (0% vs 0%, p = 1.0) and all-cause mortality (0% vs 0%, p = 1.0). SD Group patients had a significant lower procedure-related cost compared to overnight stay patients ($3,346.45 vs $4,681.99, p < 0.0001) and lower 30-day post procedure-associated cumulative costs/total operating costs ($4,493.22 vs $7,112.21, p < 0.0001). CONCLUSION: In elective patients undergoing low risk TR-PCI, same-day discharge seems to be a safe and feasible clinical practice, with significant potential savings to the US healthcare system.

Immediate and intermediate-term results of optical coherence tomography guided atherectomy in the treatment of peripheral arterial disease: Initial results from the VISION trial.

BACKGROUND: Long-term patency rates for percutaneous peripheral arterial interventions are suboptimal. Optical coherence tomography (OCT) guided atherectomy may yield superior patency by optimizing plaque removal while preserving the tunica media and adventitia. METHODS: The VISION study is a multicenter prospective study of patients with peripheral arterial disease undergoing OCT guided atherectomy with the Pantheris™ device. In 11 patients enrolled in a single center, we report procedural and clinical outcomes, at 30days and 6months. RESULTS: The mean age was 63±11years and 73% (n=8) were men. The target lesion was in the superficial femoral artery in 82% (n=9) of the patients. Mean stenosis severity was 87%±10% and mean lesion length was 39±31mm. Procedural success was observed in all patients with no device related complications. Mean post-atherectomy stenosis was 18%±15%. Almost all excised tissue consisted of intimal plaque (94%). At 30days, significant improvements in Rutherford class, VascuQoL scores and ABI were observed, 0.9±0.8 vs. 3.1±0.7 (p=0.01), 4.9±1.9 vs. 3.6±1.5 (p=0.03) and 1.04±0.19 vs. 0.80±0.19 (p<0.01) respectively. At 6months, there were significant improvements in Rutherford class (1.0±1.0 vs. 3.1±0.7, p=0.01) and ABI (0.93±0.19 versus 0.80±0.19, p=0.02) but not in VascuQoL scores (3.7±1.4 versus 3.6±1.5, p=0.48). Target lesion revascularization occurred in 18% (n=2) of the patients. CONCLUSION: OCT guided atherectomy resulted in high procedural success, no device related complications and encouraging results up to 6months. Histological analysis suggested little injury to the media and adventitia. Larger studies are needed to confirm the efficacy of this approach.

Percutaneous implantation of a parachute device for treatment of ischemic heart failure.

Congestive heart failure (CHF) secondary to ischemic cardiomyopathy is associated with significant morbidity and mortality despite currently available medical therapy. The Parachute(TM) device is a novel left ventricular partitioning device that is delivered percutaneously in the left ventricle (LV) in patients with anteroapical regional wall motion abnormalities, dilated LV and systolic dysfunction after anterior myocardial infarction with favorable clinical and LV hemodynamic improvements post-implantation. Here, we do review the current literature and present a case of the Parachute device implantation.

A poly-N-acetyl glucosamine hemostatic dressing for femoral artery access site hemostasis after percutaneous coronary intervention: a pilot study.

BACKGROUND: Arterial puncture closure devices have improved time to hemostasis and ambulation after percutaneous coronary intervention (PCI) relative to traditional manual compression, though complication rates for both methods leave room for improvement. In a pilot registry, the authors evaluated a topical hemostatic dressing containing poly-N-acetyl glucosamine (p-GlcNAc) post PCI in fully anticoagulated patients. METHODS AND RESULTS: In 100 patients undergoing PCI via the common femoral artery in the short-stay unit, the p-GlcNAc hemostatic dressing was applied with 15 minutes of manual compression at arterial access sites after arterial sheath removal. Procedural antiplatelet and anticoagulation therapies were aspirin, clopidogrel and bivalirudin. Patients were observed during 2 hours of bed rest and attempted to ambulate 2 hours post hemostasis. Effectiveness was assessed based on times to hemostasis and ambulation. Data were stratified by time elapsed since bivalirudin bolus or discontinuation of infusion (30 minutes, > 30-60 minutes, > 60 minutes). Mean time to hemostasis was 15.5 minutes. Mean time from hemostasis to ambulation was 2.08 hours; 87% of patients ambulated at 2 hours. Sheaths were removed at a mean 40.38 minutes after discontinuing bivalirudin. Anticoagulation status (as assessed by time since discontinuation of bivalirudin) did not influence time to hemostasis or ambulation. There was a single major complication (pseudoaneurysm), two minor rebleeds requiring additional manual compression, and 1 hematoma > 5 cm. CONCLUSIONS: This p-GlcNAc topical hemostatic dressing safely achieved hemostasis at arterial access sites and early ambulation, even with nearly immediate sheath removal after PCI with systemic anticoagulation using bivalirudin.