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Objectives Prior studies have shown that left ventricular diastolic dysfunction (DD) is associated with increased mortality after surgical aortic valve replacement but studies on transcatheter aortic valve replacement (TAVR) are limited and have not taken into account mitral annular calcification (MAC), which limits the use of mitral valve annular tissue Doppler imaging. We performed a single-center retrospective analysis to better evaluate the role of baseline DD on outcomes after TAVR. Methods After excluding patients with atrial fibrillation, mitral valve prostheses and significant mitral stenosis, 359 consecutive TAVR patients were included in the study. Moderate-to-severe MAC was present in 58% of the patients. We classified patients into severe versus nonsevere DD based on the evaluation of elevated left ventricular filling pressure. The outcome measure was all-cause mortality or heart failure hospitalization. Results Over a mean follow-up time of 13 months, severe DD was associated with an increased risk for the outcome measure (HR 2.02 [1.23-3.30], p = .005). However, this association was lost in a propensity-matched cohort. In multivariate analysis, STS score was the only independent predictor of all cause mortality of heart failure hospitalization (HR 1.1 [1.05-1.15], p Conclusions We evaluated the role of baseline DD on outcomes after TAVR by taking into account the presence of MAC. Severe DD was associated with increased all-cause mortality or heart failure hospitalization but not independently of other structural parameters and known predictors of the outcome measure.

The relationship between adherence to the recommended CoreValve sizing parameters and clinical outcomes is not well known for the recently released 34 mm valve, which is currently the largest available transcatheter valve. There is a presumed temporal reduction in paravalvular regurgitation in patients who receive an in-range valve, however, certain patients possess annular dimensions that are too large. We therefore describe two patients with annular dimensions larger than the manufacturer recommended range for the 34 mm CoreValve, who despite this underwent transcatheter aortic valve replacement with excellent clinical outcomes.

Objectives To evaluate the safety and effectiveness of the Closer Vascular Sealing System (VSS) against prespecified performance goals (PGs) in sealing femoral arterial access following 5–7 Fr procedures. Background Inconsistent safety profiles, costs and learning curves of earlier generation vascular closure devices have limited their widespread use following transfemoral procedures. Methods In this prospective single-arm, multi-center trial, we compared the clinical outcomes in patients undergoing 5–7 Fr transfemoral diagnostic or interventional procedures and access sites managed with Closer VSS against pre-specified PGs. The primary endpoints were time to hemostasis (TTH) and 30-day access site closure-related major complications; secondary endpoints included time to ambulation (TTA), time to discharge eligibility (TTDE), time to discharge (TTD), 30-day access site minor complications, procedure and device success. Results A total of 220 subjects (49.5% interventional) were enrolled. The mean TTH was 1.78 ± 7.81 min in the intention to treat and 0.98 ± 3.71 min in the per protocol cohort. Median TTH was 0 min with immediate hemostasis achieved in 80.5% of subjects, mean TTA was 2.50 ± 1.05 hr, and mean TTDE was 2.83 ± 1.54 hr. Thirty-day follow-up was completed on 219 subjects. There were no access site closure-related major complications, minor complication rate was 0.0% for diagnostic and 2.75% for interventional procedures. Conclusions In patients undergoing 5–7 Fr transfemoral diagnostic and interventional procedures, the CLOSER Trial met both its primary effectiveness and safety PGs. Immediate hemostasis was achieved in the majority of patients without major complication.

Objective To examine peri-procedural and long-term outcomes in patients with chronic kidney disease (CKD) undergoing percutaneous coronary interventions (PCI). Background Patients with advanced CKD are considered high risk when undergoing PCI. Limited published data exist on quantifying risk and assessment of long-term outcomes after PCI in this group. Methods Examining the Cornell Coronary Registry, we prospectively collected data of 6,478 consecutive patients who underwent elective or urgent PCI between 2009 and 2013. Patients were grouped into CKD stages by estimated glomerular filtration rate (eGFR) according to KDOQI guidelines. Procedural and 30-day outcomes are reported with assessment of long-term differences in 5-year all-cause mortality. Results Patients were grouped by CKD stages: 1,351 patients with eGFR ≥90 mL/min/1.73 m2 (stage 1), 2,882 with eGFR 60–89 (stage 2), 1,742 with eGFR 30–59 (stage 3), 191 with eGFR 15–29 (stage 4), and 312 with eGFR

Objectives We sought to examine whether baseline diastolic dysfunction (DD) is associated with increased mortality in patients who develop aortic insufficiency (AI) after transcatheter aortic valve replacement (TAVR). Background: Significant post-TAVR AI is associated with increased mortality, likely secondary to adverse hemodynamics secondary to volume overload and decreased LV compliance from chronic pressure overload. However, the effect of baseline DD on outcomes of patients with post-TAVR AI has not been studied. Methods: A total of 195 patients undergoing TAVR were included in the study. Patients with moderate-to-severe mitral stenosis, prior mitral valve replacement or atrial fibrillation were excluded. DD was classified at baseline by a 2-step approach as recommended by the American Society of Echocardiography while AI was evaluated 30 days post-TAVR. Follow up data up to 2 years post-TAVR was used in survival analysis. Results: Patients with severe baseline DD who developed ≥mild post-TAVR AI had increased mortality compared to all other patients (HR = 3.89, CI: 1.76–8.6, P = 0.001), which remained significant after adjusting for post-TAVR AI, pre-TAVR AI, baseline mitral regurgitation, ejection fraction, pulmonary artery pressure, creatinine clearance and history of stroke. Conclusions: Even mild post-TAVR AI may have a negative impact on outcomes of patients with underlying severe DD. © 2016 Wiley Periodicals, Inc.

Background Long-term clinical outcomes after exposure to non-ionic iso-osmolar contrast medium (IOCM) or ionic low-osmolar CM (LOCM) in patients with chronic kidney disease (CKD) undergoing coronary angiography are unclear. Methods The ICON trial was a prospective, double-blinded, multicentre study that randomly assigned 146 patients with CKD undergoing coronary angiography with or without percutaneous coronary intervention to the non-ionic IOCM Iodixanol or the ionic LOCM Ioxaglate. We report the 1-year clinical outcomes. Results After randomization, baseline and procedural characteristics were well-matched between the two groups. At 1 year, three deaths (4.1%) occurred in the ioxaglate and nine deaths in the iodixanol group (13.6%, P = 0.07). The cardiac death rate at 1 year was 2.7% in the ioxaglate group and 9.1% in the iodixanol group (P = 0.07). There were no significant differences in the rates of myocardial infarction (1.4% vs. 1.5%; P = 1.00) and repeated revascularization (6.8% vs. 9.1%; P = 0.75). Conclusions The use of ionic LOCM ioxaglate was associated with a numerically lower mortality at 1 year as compared to iodixanol in patients who underwent cardiac catheterization. Future studies evaluating long-term safety following exposure to different types of CM are warranted. © 2015 Wiley Periodicals, Inc.

Objective This study sought to identify the temporal trends of presenting diagnoses and vascular procedures performed for peripheral arterial disease (PAD) along with the rates of procedures and in-hospital outcomes by payer status. Background Previous studies suggest that patients with Medicare, Medicaid, or lack of insurance receive poorer quality of care leading to worse outcomes. Methods We analyzed 196,461,055 discharge records to identify all hospitalized patients with PAD records (n = 1,687,724) from January 2007 through December 2011 in the Nationwide Inpatient Sample database. Results The annual frequency of vascular procedures remained unchanged during the study period. Patients with Medicaid were more likely to present with gangrenes, whereas patients with Medicare were more likely to present with ulcers. After adjustment, patients with Medicare and Medicaid were more likely to undergo amputations when compared with private insurance/HMO (OR = 1.13, 95% CI = 1.10–1.16 and OR = 1.24, 95% CI = 1.20–1.29, respectively). Patients with both Medicare and Medicaid were less likely to undergo bypass surgery (OR = 0.82, 95% CI = 0.81–0.84 and OR = 0.87, 95% CI = 0.85–0.90, respectively), but more likely to undergo endovascular procedures (OR = 1.18, 95% CI = 1.17–1.20 and OR = 1.03, 95% CI = 1.01–1.06, respectively). Medicare and Medicaid status versus private insurance/HMO was associated with worse adjusted odds of in-hospital outcomes, including mortality after amputations, endovascular procedures, and bypass surgeries. Conclusions In this analysis, patients with Medicare and Medicaid had more comorbid conditions at baseline when compared with private insurance/HMO cohorts, were more likely to present with advanced stages of PAD, undergo amputations, and develop in-hospital complications. These data unveil a critical gap and an opportunity for quality improvement in the elderly and those with poor socioeconomic status. © 2015 Wiley Periodicals, Inc.

Transcatheter aortic valve replacement is an approved treatment for select patients with severe aortic stenosis. A rare complication of self-expanding transcatheter heart valves (THVs) is infolding of the valve stent frame, which results in a malopposed segment, perivalvular aortic insufficiency, and possibly leaflet dysfunction. We report here a successful case of balloon valvuloplasty treatment for severe infolding of a self-expandable THV in the aortic position, restoring stent frame geometry and leaflet function. © 2015 Wiley Periodicals, Inc.

A sterile inflammatory reaction at the radial access site has been described in the literature as an adverse local reaction to Cook hydrophilic coated sheaths during transradial catheterization. To date, this reaction has not been observed with non-Cook hydrophilic sheaths. Here, we describe two cases of such a reaction with Glidesheaths™ at our institution. © 2011 Wiley-Liss, Inc.

The current clinical practice guidelines categorize the use of coronary artery bypass graft (CABG) surgery for revascularization of patients with unprotected left main coronary artery disease (ULMCAD) as a class IA recommendation while it categorize the use of percutaneous coronary interventions (PCI) as a class III recommendation. The evidence underlying these recommendations is weak and out dated. The purpose of this review is to critically reevaluate current state-of-the-art with respect to revascularization of patients with ULMCAD who are acceptable surgical candidates. In doing so we will highlight the divergence between practice guidelines and patient-centered clinical decision-making; critically appraise the "evidence" underlying the current practice guidelines; review the emerging data regarding utility of CABG versus PCI in these patients; and finally discuss the elements of a contemporary approach to clinical decision-making in light of the current state of knowledge.

Objective: To assess the safety and efficacy of direct stenting using the sirolimus-eluting BX Velocity™ stent in patients with coronary lesions. Background: Although direct coronary stenting has become a widespread practice, there have been no systematic assessments of direct stenting with drug-eluting stents. Methods: Total of 225 patients with identical inclusion and exclusion criteria as the original SIRIUS trial were enrolled in this prospective single-arm study. They were compared in a no-inferiority design with 412 similar patients from the SIRIUS trial who had sirolimus-eluting stents deployed after predilatation and were preassigned to angiographic follow-up evaluation. Results: Direct stenting was successful in 85.8% of the patients. Compared with the predilatation group, direct stenting was associated with shorter median procedure duration (33 min vs. 45 min, P < 0.001). Angiographic follow-up at 8 months revealed similar late loss (in-stent—0.19 ± 0.47 mm vs. 0.17 ± 0.44 mm, and in-lesion—0.23 ± 0.41 mm vs. 0.24 ± 0.47 mm) and similar frequency of binary restenosis (in-stent—4.6% vs. 3.2% and in-lesion—6.1% vs. 8.9%) between the two treatment strategies. However, stent-edge restenosis was lower with direct stenting than in the predilatation control group (2.1% vs. 6.9%, P = 0.02). At 12-months, there were no significant differences in target lesion revascularization (3.7% vs. 5.1%, P = ns) or composite major adverse cardiac events (7.0% vs. 8.3%, P = ns). Conclusions: In patients similar to those treated in the SIRIUS trial, direct stenting using sirolimus-eluting stents achieves excellent short- and long-term clinical and angiographic results with shorter procedure time and less frequent stent edge restenosis compared with predilation stent implantation techniques. © 2007 Wiley-Liss, Inc.