Abstract Background New conduction abnormalities necessitating pacemaker implantation (PMI) is a common occurrence after TAVR. There is an increased rate of PMI in the those receiving the most contemporary implanted valve, the Edwards Sapien-3 (S3), compared to prior generation balloon expandable valves. We previously described predictors of PMI in a large cohort. Herein we sought to validate these predictors of PMI in a subsequent validation cohort. Methods We evaluated all patients undergoing first time elective TAVR with S3 at our institution (n=326). We developed a risk score based on a predictive model we have previously described. Patients received one point for each of the following: history of syncope, oversizing of the valve >16%, baseline right bundle branch block morphology, and two points for a QRS duration >115 ms. We performed regression analysis of the risk score and need for PMI. We also evaluated the performance of the risk score using ROC analysis. Results Thirty patients (8%) of the total cohort had need for PMI after S3 implantation. Those with PMI had a higher rate of pre-existing infra-nodal conduction system disease – including QRS duration >115ms (57% vs. 20%, p<0.001) and right bundle branch block (RBBB) morphology (47% vs. 10%, p<0.001) - as well as more frequent valve oversizing >15.7% (47% vs. 23%, p<0.01). There was no significant difference in a history of syncope (10% vs. 8%, p=0.72) between groups. The PMI risk score had an area under the curve of 0.753 on ROC analysis. The PMI risk score was significantly associated with PMI (OR 2.37; 95% CI [1.64–3.34], p<0.001). Rate of PMI Stratified by Risk Score Conclusions The PMI risk score was strongly predictive of the need for PMI after implantation of the S3 valve in a large validation cohort. The PMI risk score performed well in sensitivity analysis. This PMI risk score represents a simple tool to help further risk stratify patients being considered for TAVR.

PCSK9: Beyond lipid-lowering effects?/ Device-based therapy for hypertension -Where next?447 to the other groups (21.6±7.7 pg/μg protein, p<0,001) whereas no difference in plasma PCSK9 levels were found among the groups.Conclusion: These data show for the first time that PCSK9 is expressed in human PLT and significantly higher levels are found in SA+DM+ patients.The presence of PCSK9 in megakaryocytes might suggest a direct transfer from the precursor cells to the circulating PLT.Moreover we provided the evidence that PCSK9 plays a role in PLT activation and aggregation.Considering the relevance of PLT contribution to cardiovascular disease, these findings provide novel knowledge which may help to further shed light on the molecular basis of PLT hyperreactive phenotype in SA+DM+ patients.

Objective: To evaluate the safety and performance of the MobiusHD system in patients with resistant hypertension. Design and method: This is a multi-center (9 centers) non-randomized, first-in-man assessment of a nitinol self-expanding rectangular cuboid implant (MobiusHD) designed to increase carotid sinus arterial wall strain without impacting pulsatility or laminar flow. The geometric changes of the carotid sinus enhance baroreceptor sensitivity thus decreasing sympathetic activity and lowering BP. Patients with resistant hypertension (>3 antihypertensives, of which one is a diuretic, and office SBP >160 mmHg), without obstructive carotid disease received a unilateral carotid sinus MobiusHD implant. Incidence of serious adverse events and unanticipated adverse device effects were collected along with changes in blood pressure (BP) measured during 1.5-year follow-up. Results: So far 31 patients, mean age 52 (range 21–76) years, of the anticipated 50 patients received a MobiusHD implant of which 9 patients had failed on renal denervation. Mean pretreatment office BP was 182/107 (±18/15) mmHg with a median of 4.4 prescribed antihypertensives [daily defined dose (DDD): 7.4]. During follow-up 3 patients had serious adverse events (as adjudicated by the data safety monitoring board) related to procedure or device: hypotension (n = 2) and closure device failure, requiring repair (n = 1). At 180 days, 17 of the 20 patients had a reduction in office SBP >10 mmHg and/or 24-hr SBP >5 mmHg. Eight of these 17 patients had a reduction in DDD of antihypertensive medications.Conclusions: So far, implanting the MobiusHD device in patients with resistant hypertension seems to be safe and shows promising results in BP lowering.

Objective: This is a multi-center (6 centers) non-randomized, first-in-man assessment of a nitinol self-expanding rectangular cuboid implant (MobiusHD) designed to increase carotid sinus arterial wall strain without impacting pulsatility or laminar flow. The geometric changes of the carotid sinus enhance baroreceptor sensitivity thus decreasing sympathetic activity and lowering BP. Patients with stage 2 resistant hypertension (3 or more antihypertensives, of which one is a diuretic, and office SBP 160 mmHg or higher), without obstructive carotid disease received a unilateral carotid sinus MobiusHD implant. Incidence of serious adverse events and unanticipated adverse device effects were collected along with changes in blood pressure (BP) measured during 1-year follow-up. Design and method: This is a multi-center (6 centers) non-randomized, first-in-man assessment of a nitinol self-expanding rectangular cuboid implant (MobiusHD) designed to increase carotid sinus arterial wall strain without impacting pulsatility or laminar flow. The geometric changes of the carotid sinus enhance baroreceptor sensitivity thus decreasing sympathetic activity and lowering BP. Patients with stage 2 resistant hypertension (3 or more antihypertensives, of which one is a diuretic, and office SBP 160 mmHg or higher), without obstructive carotid disease received a unilateral carotid sinus MobiusHD implant. Incidence of serious adverse events and unanticipated adverse device effects were collected along with changes in blood pressure (BP) measured during 1-year follow-up. Results: So far 15 patients, mean age 55 (39–76) years, of the anticipated 40 patients received a MobiusHD implant. Mean pretreatment office BP was 181/102 (±18/11) mmHg with a median of 4.5 prescribed antihypertensives (daily defined dose (DDD): 6.6) and 6 patients had failed on renal denervation. During follow-up 3 patients had serious adverse events related to procedure or device: hypotension (n = 2) and closure device failure requiring repair (n = 1). During follow-up eleven (11) patients showed significant BP lowering (i.e. more than 10/5 mmHg decrease in office BP) and 8 required reduction in antihypertensives. Changes in DDD and BP after MobiusHD implantConclusions: So far, implanting the MobiusHD device in patients with stage 2 resistant hypertension seems to be safe and shows promising results in BP lowering.