John K. Forrest

Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study

AIMS This study aimed to evaluate the safety and performance of the TriGuard™ Embolic Deflection Device (EDD), a nitinol mesh filter positioned in the aortic arch across all three major cerebral artery take-offs to deflect emboli away from the cerebral circulation, in patients undergoing transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS The prospective, multicentre DEFLECT I study (NCT01448421) enrolled 37 consecutive subjects undergoing TAVR with the TriGuard EDD. Subjects underwent clinical and cognitive follow-up to 30 days; cerebral diffusion-weighted magnetic resonance imaging (DW-MRI) was performed pre-procedure and at 4±2 days post procedure. The device performed as intended with successful cerebral coverage in 80% (28/35) of cases. The primary safety endpoint (in-hospital EDD device- or EDD procedure-related cardiovascular mortality, major stroke disability, life-threatening bleeding, distal embolisation, major vascular complications, or need for acute cardiac surgery) occurred in 8.1% of subjects (VARC-defined two life-threatening bleeds and one vascular complication). The presence of new cerebral ischaemic lesions on post-procedure DW-MRI (n=28) was similar to historical controls (82% vs. 76%, p=NS). However, an exploratory analysis found that per-patient total lesion volume was 34% lower than reported historical data (0.2 vs. 0.3 cm3), and 89% lower in patients with complete (n=17) versus incomplete (n=10) cerebral vessel coverage (0.05 vs. 0.45 cm3, p=0.016). CONCLUSIONS Use of the first-generation TriGuard EDD during TAVR is safe, and device performance was successful in 80% of cases during the highest embolic-risk portions of the TAVR procedure. The potential of the TriGuard EDD to reduce total cerebral ischaemic burden merits further randomised investigation.

Comparison of Inhospital Mortality, Length of Hospitalization, Costs, and Vascular Complications of Percutaneous Coronary Interventions Guided by Ultrasound Versus Angiography

Despite the valuable role of intravascular ultrasound (IVUS) guidance in percutaneous coronary interventions (PCIs), its impact on clinical outcomes remains debatable. The aim of the present study was to compare the outcomes of PCIs guided by IVUS versus angiography in the contemporary era on inhospital outcomes in an unrestricted large, nationwide patient population. Data were obtained from the Nationwide Inpatient Sample from 2008 to 2011. Hierarchical mixed-effects logistic regression models were used for categorical dependent variables like inhospital mortality, and hierarchical mixed-effects linear regression models were used for continuous dependent variables like length of hospital stay and cost of hospitalization. A total of 401,571 PCIs were identified, of which 377,096 were angiography guided and 24,475 (weighted n = 119,102) used IVUS. In a multivariate model, significant predictors of higher mortality were increasing age, female gender, higher baseline co-morbidity burden, presence of acute myocardial infarction, shock, weekend and emergent admission, or occurrence of any complication during hospitalization. Significant predictors of reduced mortality were the use of IVUS guidance (odds ratio 0.65, 95% confidence interval 0.52 to 0.83; p <0.001) for PCI and higher hospital volumes (third and fourth quartiles). The use of IVUS was also associated with reduced inhospital mortality in subgroup of patients with acute myocardial infarction and/or shock and those with a higher co-morbidity burden (Charlsons co-morbidity index ≥2). In one of the largest studies on IVUS-guided PCIs in the drug-eluting stent era, we demonstrate that IVUS guidance is associated with reduced inhospital mortality, similar length of hospital stay, and increased cost of care and vascular complications compared with conventional angiography-guided PCIs.

Mechanical Circulatory Support Devices and Transcatheter Aortic Valve Implantation (from the National Inpatient Sample)

High-risk surgical patients undergoing transcatheter aortic valve implantation (TAVI) represent an emerging population, which may benefit from short-term use of mechanical circulatory support (MCS) devices. The aim of this study was to determine the practice and inhospital outcomes of MCS utilization in patients undergoing TAVI. We analyzed data from Nationwide Inpatient Sample (2011 and 2012) using the International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes. A total of 1,794 TAVI procedures (375 hospitals in the United States) were identified of which 190 (10.6%) used an MCS device (MCS group) and 1,604 (89.4%) did not (non-MCS group). The use of MCS devices with TAVI was associated with significant increase in the inhospital mortality (14.9% vs 3.5%, p <0.01). The mean length (11.8 ± 0.8 vs 8.1 ± 0.2 days, p <0.01) and cost (

Relationship of Annular Sizing Using Multidetector Computed Tomographic Imaging and Clinical Outcomes After Self-Expanding CoreValve Transcatheter Aortic Valve Replacement

68,997 ± 3,656 vs

Trends of Hospitalizations in the United States from 2000 to 2012 of Patients >60 Years With Aortic Valve Disease.

55,878 ± 653, p = 0.03) of hospitalization were also significantly greater in the MCS group. Ventricular fibrillation arrest, transapical access for TAVI, and cardiogenic shock were the most significant predictors of MCS use during TAVI. In the multivariate model, use of any MCS device was found to be an independent predictor of increased mortality (odds ratio 3.5, 95% confidence interval 2.6 to 4.6, p <0.0001) and complications (odds ratio 3.3, 95% confidence interval 2.8 to 3.9, p <0.0001). The propensity score-matched analysis also showed a similar result. In conclusion, the unacceptably high rates of mortality and complications coupled with a significant increase in the length and cost of hospitalization should raise concerns about utility of MCS devices during TAVI in this prohibitive surgical risk population.

Cadmium disrupts the signal transduction pathway of both inhibitory and stimulatory receptors regulating chloride secretion in the shark rectal gland

Background—Multidetector computed tomography is useful for determining the appropriate transcatheter heart valve (THV) size in patients with severe aortic stenosis who are suboptimal surgical candidates. The relationship between adherence to the recommended CoreValve sizing algorithm and clinical outcomes is not known. Methods and Results—We evaluated 1023 patients with severe aortic stenosis deemed high or extreme risk for surgery treated with the CoreValve THV. All patients underwent preprocedural multidetector computed tomography, and the scans were reviewed at a central analysis center using standardized software. Compliance to a recommended sizing algorithm was used to identify patients with below-range, in-range, and above-range THV sizing. A device annular sizing ratio (DAR) was also calculated based on the native annulus perimeter and perimeter of the selected THV. Clinical end points included the presence of paravalvular aortic regurgitation evaluated by an independent echocardiographic laboratory. Adherence to the sizing algorithm was highest with a 31-mm THV (92.6%) and lowest with the 23-mm THV (38.5%). Below-range sizing was associated with a higher rate of moderate or severe paravalvular aortic regurgitation (15.3%) than in-range (6.5%) or above-range (10.0%; P<0.001) sizing. Higher DARs were associated with lower rates of moderate or severe paravalvular aortic regurgitation: DAR ⩽10%, 17.6%; DAR 10% to 15%, 9.9%; DAR 15% to 20%, 6.3%; and DAR >20%, 4.9%; P<0.001. There was no increase in clinical events associated with higher DARs. Conclusions—Adherence to a sizing algorithm guided by multidetector computed tomography resulted in lower rates of paravalvular aortic regurgitation after self-expanding transcatheter valve replacement without an increase in complications. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01240902.

Transcatheter aortic valve replacement versus surgical aortic valve replacement in patients with cirrhosis

In recent years, there has been an increased emphasis on the diagnosis and treatment of valvular heart disease and, in particular, aortic stenosis. This has been driven in part by the development of innovative therapeutic options and by an aging patient population. We hypothesized an increase in the number of hospitalizations and the economic burden associated with aortic valve disease (AVD). Using Nationwide Inpatient Sample from 2000 to 2012, AVD-related hospitalizations were identified using International Classification of Diseases, Ninth Revision, Clinical Modification, code 424.1, as the principal discharge diagnosis. Overall AVD hospitalizations increased by 59% from 2000 to 2012. This increase was most significant in patients >80 years and those with higher burden of co-morbidities. The most frequent coexisting conditions were hypertension, heart failure, renal failure, anemia, and diabetes. Overall inhospital mortality of patients hospitalized for AVD was 3.8%, which significantly decreased from 4.5% in 2000 to 3.5% in 2012 (p <0.001). The largest decrease in mortality was seen in the subgroup of patients who had heart failure (62% reduction), higher burden of co-morbidities (58% reduction), and who were >80 years (53% reduction). There was a substantial increase in the cost of hospitalization in the last decade from

Impact of Hospital Volume on Outcomes of Endovascular Stenting for Adult Aortic Coarctation

31,909 to

Intravascular Ultrasound in Lower Extremity Peripheral Vascular Interventions Variation in Utilization and Impact on In-Hospital Outcomes From the Nationwide Inpatient Sample (2006–2011)

38,172 (p <0.001). The total annual cost for AVD hospitalization in the United States increased from

Variability in utilization of drug eluting stents in United States: Insights from nationwide inpatient sample

1.3 billion in 2001 to