TransCatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and multivessel or advanced coronary disease: The transcatheter valve and vessels trial (TCW trial): Design and rationale.

BACKGROUND: Patients with severe aortic stenosis (AS) frequently present with concomitant obstructive coronary artery disease (CAD). In those, current guidelines recommend combined coronary artery bypass grafting (CABG) and surgical aortic valve replacement (SAVR) as the preferred treatment option, although this surgical approach is associated with a high rate of clinical events. Combined transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) with or without FFR have evolved as a valid alternative for cardiac surgery in patients with AS and multivessel or advanced CAD. To date, no dedicated trial has prospectively evaluated the outcomes of a percutaneous versus surgical treatment for patients with both severe AS and CAD. AIMS: To investigate whether fractional-flow reserve (FFR)-guided PCI and TAVI is noninferior to combined CABG and SAVR for the treatment of severe AS and multivessel or advanced CAD. METHODS: The Transcatheter Valve and Vessels (TCW) trial (clinicaltrial.gov: NCT03424941) is a prospective, randomized, controlled, open label, international trial. Patients ≥ 70 years with severe AS and multivessel (≥ 2 vessels) or advanced CAD, deemed feasible by the heart team for both; a full percutaneous or surgical treatment, will be randomised in a 1:1 fashion to either FFR-guided PCI followed by TAVI (intervention arm) vs. CABG and SAVR (control arm). The primary endpoint is a patient-oriented composite of all-cause mortality, myocardial infarction, disabling stroke, unscheduled clinically-driven target vessel revascularization, valve reintervention, and life threatening or disabling bleeding at 1 year. The TCW trial is powered for noninferiority, and if met, superiority will be tested. Assuming a primary endpoint rate of 30% in the CABG-SAVR arm, with a significance level α of 5%, a noninferiority limit delta of 15% and a loss to follow-up of 2%, a total of 328 patients are needed to obtain a power of 90%. The primary endpoint analysis is performed on an intention-to-treat basis. SUMMARY: The TCW Trial is the first prospective randomized trial that will study if a less invasive percutaneous treatment for severe AS and concomitant advanced CAD (i.e., FFR-guided PCI-TAVI) is noninferior to the guidelines recommended approach (CABG-SAVR).

Dedicated plug based closure for large bore access -The MARVEL prospective registry.

OBJECTIVES: To study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers. BACKGROUND: The MANTA is a novel plug-based device for large bore arteriotomy closure. METHODS: We included all eligible patients who underwent transfemoral large bore percutaneous procedures. Exclusion criteria were per operator's discretion and included severe calcification or marked tortuosity of the access vessel, presence of marked obesity/cachexia or a systolic blood pressure above 180 mmHg. The primary performance endpoint was time to hemostasis. Primary and secondary safety endpoints were major and minor access site related vascular complications up to 30 days, respectively. Vascular complications were adjudicated by an independent clinical event committee according to VARC-2 criteria. We performed multivariable logistic regression to estimate the effect of baseline and procedural characteristics on any and major vascular complications. RESULTS: Between February 2018 and July 2019 500 patients were enrolled undergoing Transcatheter aortic valve replacement (TAVR, N = 496), Balloon aortic valvuloplasty (BAV, N = 2), Mechanical circulatory support (MCS, N = 1) or Endovascular aneurysm repair (EVAR, N = 1). Mean age was 80.8 ± 6.6 years with a median STS-score of 2.7 [IQR 2.0-4.3] %. MANTA access site complications were major in 20 (4%) and minor in 28 patients (5.6%). Median time to hemostasis was 50 [IQR 20-120] sec. Severe femoral artery calcification, scar presence in groin, longer procedure duration, female gender and history of hypertension were independent predictors for vascular complications. CONCLUSION: In this study, MANTA appeared to be a safe and effective device for large bore access closure under real-world conditions.

A global registry of fractional flow reserve (FFR)-guided management during routine care: Study design, baseline characteristics and outcomes of invasive management.

BACKGROUND: The use and clinical outcomes of fractional flow reserve (FFR)-guided revascularization in patients presenting with either stable coronary artery disease (CAD) or an acute coronary syndrome (ACS) in daily clinical practice are uncertain. OBJECTIVE: To prospectively characterize the frequency of the change in treatment plan when FFR is performed compared to the initial decision based on angiography alone and procedure-related outcomes. METHODS: We undertook a prospective, multicenter, multinational, open-label, observational study of coronary physiologic measurements during clinically indicated coronary angiography. The treatment plan, including medical therapy, PCI or CABG, was prospectively recorded before and after performing FFR. Adverse events were pre-defined and prospectively recorded per local investigators (PRESSUREwire; ClinicalTrials.gov identifier: NCT02935088). RESULTS: Two thousand two hundred and seventeen subjects were enrolled in 70 hospitals across 15 countries between October 2016-February 2018. The mean FFR (all measurements) was 0.84. The treatment plan based on angiography-alone changed in 763/2196 subjects (34.7%) and 872/2931 lesions (29.8%) post-FFR. In the per-patient analysis, the initial treatment plan based on angiography versus the final treatment plan post-FFR were medical management 1,350 (61.5%) versus 1,470 (66.9%) (p = .0017); PCI 717 (32.7%) versus 604 (27.5%) (p = .0004); CABG 119 (5.4%) versus 121 (5.5%) (p = .8951). The frequency of intended revascularization changed from 38.1 to 33.0% per patient (p = .0005) and from 35.5 to 29.6% per lesion (p < .0001) following FFR. CONCLUSIONS: On an individual patient basis, use of FFR in everyday practice changes the treatment plan compared to angiography in more than one third of all-comers selected for physiology-guided managements. FFR measurement is safe, providing incremental information to guide revascularization decisions.

"Virtual" 3 Fr Transradial Coronary Stenting With the 5 Fr Meito Masamune Sheathless Guiding Catheter: Feasibility and Safety in an Outpatient Setting.

AIM: To assess the safety and feasibility of "virtual 3 Fr" transradial percutaneous coronary intervention (TRA-PCI) in an outpatient setting. METHODS AND RESULTS: A retrospective analysis of a single-operator log-book, for the first 2 months after its CE-mark approval, identified 11/52 patients (21%; 6/11 males; mean age, 64 ± 10 years) who had undergone: (1) an elective TRA-PCI; (2) in an outpatient setting; and (3) with the sheathless 5 Fr Meito-Masamune guiding catheter (Medikit Co, Ltd). Procedural success was 96% (25/26 lesions), mean procedural time and contrast usage were 26 ± 15 minutes and 94 ± 69 mL, respectively. Patent hemostasis was successful in 10/11 patients, all patients were discharged home within 6 hours, and no acute radial artery occlusion occurred. CONCLUSIONS: Virtual 3 Fr TRA-PCI in highly selected patients seems feasible and safe when performed in an outpatient setting.

Safety and feasibility of a PAclitaxel-eluting balloon angioplasty in Primary Percutaneous coronary intervention in Amsterdam (PAPPA): one-year clinical outcome of a pilot study.

AIMS: In primary percutaneous coronary intervention (PPCI), stenting has been shown to reduce the need for repeat target lesion revascularisation (TLR) compared to balloon angioplasty alone, but did not result in a reduction of recurrent myocardial infarction (MI) or cardiac death. Meanwhile, stent-related adverse events such as stent thrombosis continue to be of concern. Our aim was to evaluate the safety and feasibility of drug- coated balloon (DCB) angioplasty without stenting in PPCI. METHODS AND RESULTS: One hundred patients presenting with ST-elevation MI were prospectively enrolled in this pilot study. They underwent PPCI with DCB angioplasty; additional stenting was allowed only in case of type C to F coronary dissection or residual stenosis >50%. All patients were treated with i.v. bivalirudin. The primary endpoint was the composite of cardiac death, recurrent MI and TLR. A total of 59 patients received treatment with DCB angioplasty alone, whereas additional stenting was required in 41 patients. One-year clinical follow-up was completed in 98 patients. A total of five major adverse cardiac events were reported (5%). Cardiac death was seen in two patients, while three patients underwent TLR. CONCLUSIONS: This first study of a DCB angioplasty-only strategy in the setting of PPCI showed good one-year clinical results.

Transradial approach for coronary angiography and interventions in patients with coronary bypass grafts: tips and tricks.

Among patients undergoing coronary procedures, patients with coronary artery bypass grafts represent an important, high risk subgroup. Routine transradial approach may be successfully adopted in these patients to reduce access-site complications. However, transradial cannulation of the grafts may result technically demanding. In this article we discuss the specific technical issues and we present a series of tips and tricks which may facilitate angiography and interventions on both internal mammary and aorto-coronary grafts.

Left ventricular remodeling after primary coronary angioplasty in patients treated with abciximab or intracoronary adenosine.

BACKGROUND: Primary angioplasty is the best treatment of acute myocardial infarction but fails to achieve adequate myocardial reperfusion in 25% to 30% of patients, despite TIMI grade 3 flow. Drug treatment aimed at reducing the no-reflow phenomenon may improve myocardial salvage, thus preventing left ventricular remodeling. Our aim was to evaluate the impact of abciximab and adenosine on immediate angiographic results and on 6-month left ventricular remodeling. METHODS: Ninety consecutive patients undergoing primary angioplasty with coronary stenting were randomized in a sequential alternating fashion to standard abciximab treatment (ABCX) group, intracoronary adenosine distal to the occlusion (ADO) group, or neither (CTRL) group. All patients underwent a clinical and echocardiographic follow-up at 1 and 6 months. The primary end point was the prevalence of 6-month left ventricular remodeling. RESULTS: Baseline clinical, echocardiographic, and angiographic characteristics were similar. Mean final corrected TIMI frame count was 17 +/- 9, 16 +/- 12, and 23 +/- 11 frames in ABCX, ADO, and CTRL patients, respectively (P = .002). Angiographic no-reflow was observed in 7%, 13%, and 17% of ABCX, ADO, and CTRL patients, respectively (P > .20). At 6 months, left ventricular remodeling occurred in 7%, 30%, and 30% of ABCX, ADO, and CTRL patients, respectively (P = .045), with a percent increase in end-diastolic volume of 5% +/- 13%, 15% +/- 15%, and 12% +/- 18% (P = .04). CONCLUSIONS: During primary angioplasty, abciximab enhances myocardial reperfusion, translating into a reduced incidence of 6-month left ventricular remodeling. In contrast, adenosine administration improves angiographic results but does not prevent left ventricular remodeling.

Differential localisation of the renin-angiotensin system in de-novo lesions and in-stent restenotic lesions in in-vivo human coronary arteries.

OBJECTIVE: Different components of the renin-angiotensin system (RAS) have been demonstrated in atherosclerotic plaques. However, the involvement of the RAS in in-stent restenosis is not clear. We studied the differential immunolocalisation of angiotensin converting enzyme (ACE) and the angiotensin II type 1 (AT1) receptor in de-novo stenotic lesions and in-stent restenotic lesions in human coronary arteries. METHODS: Using a pullback atherectomy catheter, biopsies from de-novo coronary lesions (n=19) and in-stent restenotic lesions (n=19) were obtained. The biopsies were immunostained for vascular smooth muscle cells (VSMCs), macrophages, ACE and the AT1 receptor. RESULTS: In biopsies from de-novo stenotic lesions ACE-positive macrophages were more numerous than in in-stent restenotic lesions (P=0.002). Moreover, in the latter lesions, ACE-positive macrophages decreased when the time interval of stent implantation was longer. On the other hand, in-stent restenotic lesions contained predominantly young VSMCs, which abundantly expressed AT1 receptors. CONCLUSIONS: Lesional ACE expression is not a prominent feature of in-stent restenotic lesions. In contrast, AT1 receptors are abundantly expressed on young VSMCs. In de-novo lesions ACE and AT1 receptors were found on macrophages and VSMCs, which were present in all specimens.