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.

Uninterrupted oral anticoagulation versus bridging in patients with long-term oral anticoagulation during percutaneous coronary intervention: subgroup analysis from the WOEST trial.

AIMS: To investigate the optimal periprocedural antithrombotic strategy in patients on long-term oral anticoagulation (OAC) who require percutaneous coronary intervention with stenting. METHODS AND RESULTS: The WOEST study was a randomised controlled trial which recruited 573 patients on long-term OAC who underwent PCI. The periprocedural treatment strategy was left to the operator's discretion. To assess the safety and feasibility of uninterrupted oral anticoagulation (UAC) and bridging therapy (BT), bleeding complications and MACCE were assessed in patients treated according to UAC (n=241) and BT (n=322) regimen. After 30 days, as well as after one year, there were no significant differences in bleeding complications (HR 1.14, 95% CI: 0.77-1.69, p=0.51, and HR 1.26, 95% CI: 0.94-1.69, p=0.12, respectively) and MACCE. MACCE tended to be less frequent in the UAC group (respectively HR 0.48, 95% CI: 0.15-1.51, p=0.21, and HR 0.72, 95% CI: 0.46-1.14, p=0.16). Additionally, adjustment with a propensity score revealed no significant differences. Periprocedural INR was not associated with bleeding or MACCE. CONCLUSIONS: In the WOEST study, UAC was not associated with an increase of bleeding or MACCE compared to bridging therapy. This is the largest study up to now to support the current guidelines. The WOEST trial is registered with ClinicalTrials.gov, number NCT00769938.

Occurrence, fate and consequences of ventricular conduction abnormalities after transcatheter aortic valve implantation.

AIMS: Transcatheter aortic valve implantation (TAVI) is frequently complicated by new left bundle branch block (LBBB). We investigated the development and persistence of LBBB during follow-up and its clinical consequences. METHODS AND RESULTS: ECGs at baseline, within 24 hours, before discharge and at 12 months after TAVI were assessed in 476 patients without pre-existing LBBB and/or pacemaker before or after TAVI. TAVI-induced new LBBB was categorised based on the timing of the occurrence (within 24 hours [acute], after 24 hours but before discharge [subacute], and after discharge [late]), in addition to persistence (transient or persistent). A total of 175 patients (36.8%) developed new LBBB of which 85.7% occurred within 24 hours after TAVI, 12.0% before and 2.3% after hospital discharge, and was persistent in 111 patients (63.4%). Implantation of the Medtronic CoreValve System (MCS) more frequently led to new LBBB than the balloon-expandable Edwards SAPIEN valve (ES) (53.8% versus 21.7%) with less recovery during follow-up (39.0% versus 9.5%). Late new LBBB was only seen in four patients (0.8%). During a median follow-up of 915 (578-1,234) days, persistent LBBB was associated with a significant increase in mortality as compared to no LBBB and temporary LBBB combined (hazard ratio 1.49, 95% confidence interval, 1.10-2.03; p=0.01). CONCLUSIONS: TAVI-induced new LBBB occurs in almost 40% of patients, almost all before hospital discharge. It occurs three times more frequently after MCS than after ES valve implantation and has a twofold lower tendency to resolve during follow-up. Persistent LBBB is associated with a higher mortality.