Comparison of acute recoil after valve deployment and after post-dilation in patients undergoing transfemoral-transcatheter aortic valve replacement with SAPIEN-3 valve.

BACKGROUND: Transcatheter aortic valves are prone to acute recoil similar to the metal-based coronary stents. However, it is not clear if recoil remains a factor only after the initial valve deployment or also after post-dilation. METHODS: We conducted a retrospective observational study of patients who underwent transfemoral transcatheter aortic valve replacement (TAVR) with SAPIEN-3 valve. Acute recoil at the upper, central, and lower levels of the valve was calculated in both anteroposterior right anterior oblique (RAO) and lateral left anterior oblique (LAO) views after initial deployment as well as after post-dilation. The average recoil of the RAO and LAO views was also calculated and described as RAO/LAO. RESULTS: The acute recoil in the RAO/LAO views (mean ± SD) was 3.9 ± 1.1% after valve deployment in the whole study population (n = 257). Among the subset of patients who required post-dilation (n = 133), the mean acute recoil in the RAO/LAO views was found to be greater after initial valve deployment as compared with after post-dilation (3.8 ± 1.1% vs. 3.0 ± 0.9%; p < .001). Further, acute recoil was significantly greater in the RAO view than the LAO view and at the central level of the prosthesis as compared with the upper and lower levels. Those findings were consistent after initial deployment as well as after post-dilation. Clinical outcomes were similar between patients who required post-dilation compared to those who did not. In multivariable logistic regression analysis, only smaller valve cover index was found to be an independent predictor of 30-day mild or greater aortic regurgitation (OR 0.007; 95% CI 0.0001-0.707; p = .035). CONCLUSION: Acute elastic recoil of the SAPIEN-3 valve was significantly less after post-dilation as compared with after deployment. It was also greater when measured in the RAO view as compared with the LAO view. Furthermore, acute recoil was not homogenous across the height of the valve stent frame.

The utilization of single versus double Perclose devices for transfemoral aortic valve replacement access site closure: Insights from Cleveland Clinic Aortic Valve Center.

INTRODUCTION: Percutaneous femoral access is the preferred access route for transcatheter aortic valve replacement (TAVR). The majority of experienced TAVR centers use two 6F Perclose ProGlide™ devices to close the primary vascular access site, deployed prior to upsizing sheath size with closure completed at the end of the case (the "preclose" approach). A strategy of utilizing a single Perclose device to preclose may have advantages including fewer complications, complexity, and cost, but the safety of this is unknown. This study examines in the safety and efficacy of using a single Perclose versus double Perclose for perclosure of large bore access during TAVR. METHODS: Patients undergoing Transfemoral (TF) TAVR from January 2014 to December 2017 within the Cleveland Clinic Aortic Valve Center were identified. A retrospective review of medical charts was conducted. Vascular complications were defined according to the VARC-2 criteria. RESULTS: A total of 740 patients were included; 487 (65.8%) received a single Perclose device while 253 (34.2%) received double Perclose devices. Baseline characteristics were similar with no differences between the single versus double Perclose groups, respectively. The access sheath size was similar in both groups with (14, 16, and 18 F) being the most common sizes utilized. Of the total 487 patients with single Perclose, 75.6% needed additional closure device (AngioSeal). With double Perclose strategy, additional closure device (AngioSeal) was used in 40.3% patients with 470 (63.5%) patients being successfully perclosed. Vascular complication rates including hematoma, stenosis requiring stenting, pseudoaneurysm, and other major vascular complications were similar between both groups. CONCLUSION: Single 6F ProGlide use for preclosure is a safe strategy for TF TAVR using the S3 valve. Additional closure device was not needed in almost one-quarter of the patients. When necessary, residual bleeding can be controlled with the AngioSeal Device at the end of the procedure. This single device preclose strategy can help to reduce the cost of TAVR procedure without increasing risk.

Is There a Safety Concern for Drug-Coated Balloons in Peripheral Arterial Disease?

PURPOSE OF REVIEW: Drug-coated balloons (DEB) and drug-eluting stents (DES) emerged as a tool to aid in lowering the rates of neointimal hyperplasia and target lesion restenosis following endovascular peripheral arterial disease (PAD) interventions. RECENT FINDINGS: Although the initial trials comparing these devices with non-drug balloons and stents showed favorable results, more recent data raised concerns regarding the mid to long-term safety of these devices. In this review, we will discuss the evolution of endovascular therapy for PAD, with highlights regarding the recent debates on the long-term safety of the drug-coated devices for treatment of PAD.

Supplemental calcium and vitamin D and long-term mortality in aortic stenosis.

OBJECTIVE: Calcium metabolism has long been implicated in aortic stenosis (AS). Studies assessing the long-term safety of oral calcium and/or vitamin D in AS are scarce yet imperative given the rising use among an elderly population prone to deficiency. We sought to identify the associations between supplemental calcium and vitamin D with mortality and progression of AS. METHODS: In this retrospective longitudinal study, patients aged ≥60 years with mild-moderate native AS were selected from the Cleveland Clinic Echocardiography Database from 2008 to 2016 and followed until 2018. Groups were stratified into no supplementation, supplementation with vitamin D alone and supplementation with calcium±vitamin D. The primary outcomes were mortality (all-cause, cardiovascular (CV) and non-CV) and aortic valve replacement (AVR), and the secondary outcome was AS progression by aortic valve area and peak/mean gradients. RESULTS: Of 2657 patients (mean age 74 years, 42% women) followed over a median duration of 69 months, 1292 (49%) did not supplement, 332 (12%) took vitamin D alone and 1033 (39%) supplemented with calcium±vitamin D. Calcium±vitamin D supplementation was associated with a significantly higher risk of all-cause mortality (absolute rate (AR)=43.0/1000 person-years; HR=1.31, 95% CI (1.07 to 1.62); p=0.009), CV mortality (AR=13.7/1000 person-years; HR=2.0, 95% CI (1.31 to 3.07); p=0.001) and AVR (AR=88.2/1000 person-years; HR=1.48, 95% CI (1.24 to 1.78); p<0.001). Any supplementation was not associated with longitudinal change in AS parameters in a linear mixed-effects model. CONCLUSIONS: Supplemental calcium with or without vitamin D is associated with lower survival and greater AVR in elderly patients with mild-moderate AS.

Oral Calcium Supplements Associate With Serial Coronary Calcification: Insights From Intravascular Ultrasound.

OBJECTIVES: This study sought to evaluate and assess the extent of serial coronary artery calcification in response to oral calcium supplementation. BACKGROUND: Oral calcium supplements are frequently used despite their cardiovascular safety remaining controversial. Their effects on serial coronary calcification are not well established. METHODS: In a post hoc patient-level analysis of 9 prospective randomized trials using serial coronary intravascular ultrasound, changes in serial percentage of atheroma volume (PAV) and calcium indices (CaI) were compared in matched segments of patients coronary artery disease who were receiving concomitant calcium supplements (n = 447) and in those who did not receive supplements (n = 4,700) during an 18- to 24-month trial period. RESULTS: Patients (mean age 58 ± 9 years; 73% were men; 43% received concomitant high-intensity statins) demonstrated overall annualized changes in PAV and CaI with a mean of -0.02 ± 1.9% (p = 0.44) and a median of 0.02 (interquartile range: 0.00 to 0.06) (p < 0.001) from baseline, respectively. Following propensity-weighted mixed modeling adjusting for treatment and a range of demographic, clinical, ultrasonic, and laboratory parameters (including but not limited to sex, race, baseline, and annualized change in PAV, baseline CaI, concomitant high-intensity statins, diabetes mellitus, renal function), there were no significant between-group differences in annualized changes in PAV (least-squares mean: 0.09; 95% confidence interval [CI]: -0.20 to 0.37 vs. 0.01; 95% CI: -0.27 to 0.29; p = 0.092) according to calcium supplement intake. Per a multivariable logistic regression model accounting for the range of covariates described, calcium supplementation independently associated with an increase in annualized CaI (odds ratio: 1.15; 95% CI: 1.05 to 1.26; p = 0.004). CONCLUSIONS: Oral calcium supplementation may increase calcium deposition in the coronary vasculature independent of changes in atheroma volume. The impact of these changes on plaque stability and cardiovascular outcomes requires further investigation.

Incidence, Clinical Presentation, and Causes of 30-Day Readmission Following Hospitalization With Spontaneous Coronary Artery Dissection.

OBJECTIVES: The aim of this study was to investigate the impact of spontaneous coronary artery dissection (SCAD) on 30-day readmission rates following hospitalization with acute myocardial infarction (AMI) using a national database. BACKGROUND: AMI in the setting of SCAD represents an uncommon type of myocardial infarction with limited data on short-term outcomes. METHODS: All hospitalizations with primary or index diagnoses of AMI from 2010 to 2015 in the Nationwide Readmissions Database were queried. The primary outcome was overall 30-day readmission rates in both SCAD and non-SCAD cohorts. Propensity score matching (1:2) was conducted. RESULTS: A total of 2,654,087 patients with AMI were included in the final analysis, of whom 1,386 (0.052%) were diagnosed with SCAD. SCAD was associated with a higher readmission rate in the SCAD cohort (12.3% vs. 9.9%; p = 0.022). The main causes of readmissions in the SCAD cohort were cardiac causes (80.6%), and AMI was the most common cardiac cause (44.8%), followed by chest pain (20.1%) and arrhythmia (12.7%). Among the SCAD readmissions, 50.6% patients were readmitted in the first week post-discharge, with 54.5% of AMI readmissions occurring in the first 2 days post-discharge. CONCLUSIONS: The incidence of 30-day readmission following AMI and SCAD is nontrivial and occurs early post-discharge. Most readmissions are due to cardiac causes, especially AMI. Targeted management approaches are needed to diminish the high rates of readmission and early recurrent AMI.

The Utility of Rapid Atrial Pacing Immediately Post-TAVR to Predict the Need for Pacemaker Implantation.

OBJECTIVES: The aim of this study was to determine the utility of rapid atrial pacing immediately after transcatheter aortic valve replacement (TAVR) to predict the need for permanent pacemaker implantation (PPI). BACKGROUND: Risk stratification for patients without high-grade atrioventricular block (AVB) after TAVR is imprecise and based on anatomic considerations, electrocardiographic characteristics, and clinical suspicion. A more reliable assessment is necessary to minimize inpatient rhythm monitoring and/or reduce unnecessary PPI. METHODS: Consecutive patients undergoing TAVR at 2 centers were included. After valve implantation in patients without pacemakers who did not have complete heart block or atrial fibrillation, the temporary pacemaker was withdrawn from the right ventricle and placed in the right atrium. Rapid atrial pacing was performed from 70 to 120 beats/min, and patients were assessed for the development of Wenckebach AVB. Patients were then followed for clinical outcomes, including PPI. RESULTS: A total of 284 patients were included. Of these, 130 (45.8%) developed Wenckebach AVB. There was a higher rate of PPI within 30 days of TAVR among the patients who developed Wenckebach AVB (13.1% vs. 1.3%; p < 0.001), with a negative predictive value for PPI in the group without Wenckebach AVB of 98.7%. A greater percentage of patients receiving self-expanding valves required PPI than those receiving a balloon-expandable valves (15.9% vs. 3.7%; p = 0.001), though these rates were still relatively low among patients who did not develop Wenckebach AVB (2.9% and 0.8%). CONCLUSIONS: Atrial pacing post-TAVR is easily performed and can help identify patients who may benefit from extended rhythm monitoring. Patients who did not develop pacing-induced Wenckebach AVB demonstrated an extremely low likelihood of PPI.