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To study rotational atherectomy (RA) outcomes in patients undergoing high-risk PCI randomized to receive hemodynamic support using either IABP or Impella 2.5 in the PROTECT II trial.RA of heavily calcified lesions is often necessary for complex PCI but can be associated with slow-flow, hypotension, and higher risk of periprocedural MI.We compared baseline, angiographic, procedural characteristics, and outcomes of patients treated with and without RA. We examined also RA technique and outcomes.RA was used in 52 of 448 patients (32 with Impella vs 20 with IABP, P = 0.08). RA patients were older (72 vs. 67 yo, P = 0.0009), more likely to have prior CABG (48 vs. 32%, P = 0.017), higher STS (8.1 vs. 5.7, P = 0.012) and higher SYNTAX scores (37 vs. 29, P0.0001). At 90 days, RA use was associated with higher incidence of MI but no mortality difference. RA was used more aggressively with Impella resulting in higher rate of periprocedural MI (P0.01), with no difference in mortality between groups (P = 0.78). Repeat revascularization occurred less frequently with Impella (P0.001). There were no differences in 90-day major adverse events between IABP and Impella in patients undergoing RA (P = 0.29). In patients not treated with RA, fewer MAEs were observed with Impella compared with IABP (P = 0.03).Patients who were treated with RA had more comorbidities, and more complex and extensive coronary artery disease. In patients with Impella, more aggressive RA use resulted in fewer revascularization events but higher incidence of periprocedural MI.

Background: Prior studies have investigated the effect of influenza vaccination on cardiovascular mortality (CVM). The influence of vaccinations other than influenza and CVM has not been investigated before. Methods: The public dataset of National Health and Nutrition Examination Survey III (NHANES III) between the years 1988-1994 and continuous NHANES from 1999-2004 was used for this analysis. From NHANES III, we included patients >18 years old with available data on positive antibody against measles, mumps, rubella, diphtheria, pertussis or tetanus. From continuous NHANES, we included patients >18 years with available titers and vaccination history on hepatitis A, hepatitis B and pneumococcus. Protective titers were analyzed as per standardized cut offs. The primary outcome was CVM per National Death Index. Traditional cardiac risk factors along with CRP and social class (insurance, income and education level) were adjusted for in the multivariable analysis. Results: There were 1,848 (9.7%) cardiovascular deaths with a mean follow up of 13 years for NHANES III. There were 366 (2.3%) cardiovascular deaths with a mean follow up of 4.7 years for continuous NHANES. Multivariable analysis from NHANES III and continuous NHANES did not show any influence of individual seroprotective titers of routine vaccinations on CV mortality. In the multivariable model, significant predictors of mortality were age (p Conclusion: Our observational study in a large database suggests that presence of non-influenza vaccination antibodies is not associated with decreased cardiovascular mortality in a nationally representative cohort.

Background: Utilization of intra-aortic balloon pump (IABP) and left ventricular assist device (LVAD) during percutaneous coronary intervention (PCI) has increased in recent years. We analyzed the trends and predictors of hospitalization cost associated with high risk PCI in US over a 5 year period (2005-2010). Methods: We queried the Healthcare Cost and Utilization Project’s Nationwide Inpatient Sample (NIS) between 2005 and 2010 using the ICD9 procedure code of 36.07 and 36.06 for PCI. The NIS represents 20% of all hospitals in the US and is the largest all payer hospital discharge database. We defined high risk PCI as PCI plus LVAD (ICD-9 code 37.68, 37.62) or IABP placement (ICD-9 code 37.61) during the same hospital admission. We examined the selective contribution of patient demographics, insurance type, and hospital characteristics, Deyo modification of Charlson comorbidity index (CCI) and hospital PCI volume (split into quartiles with first quartile as referent) to hospitalization cost. For each year, cost was adjusted for inflation according to the 2010 cost. The independent predictors of hospitalization cost were calculated by mixed effects linear regression modeling incorporating hospital ID as random effects. Results: 26,300 (weighted n = 130,151) number of patients were identified. Overall hospitalization cost associated with high risk PCI increased from $137,354 in 2005 to $160,736 in 2010 (P Conclusion: In this observational study we demonstrated that increased hospitalization cost for high risk PCI is associated with teaching hospital, CCI, presence of MI or shock and occurrence of periprocedural complications. We also found use of IABP, female sex, having private, self-pay or no insurance to be associated with a decreased hospitalization cost related to high risk PCI in the US over a 5 year period from 2005-2010.

Background: Prior studies analyzing the effect of infection and cardiovascular events have met with contradictory results. We investigated whether infectious burden increases cardiovascular mortality in a cross sectional US population. Methods: The public dataset of the National Health and Nutrition Examination Survey III (NHANES III) between the years 1988-1994 was used for the analysis. We included patients >18 years with data on positive antibodies against Hepatitis A, Hepatitis B, Hepatitis C, Hepatitis E, Herpes simplex virus 1 and 2, Toxoplasma, Varicella, Cytomegalovirus (CMV), Human herpes virus -8 and Toxocara (n= 7,876). These infections were combined to create a total infection burden variable. This variable was split into quartiles. The primary outcome was cardiovascular (CV) mortality. Traditional cardiac risk factors along with C-reactive protein (CRP) and social class (insurance, income and education level) were adjusted for in the multivariable analysis. Results: 431 (5.5%) of cardiovascular deaths were reported with a mean follow up of 14.5 years. On a univariable analysis only positive toxoplasma antibody (HR, 95% CI, p-value) were predictive of CV mortality (1.18.,1.03-1.36, 0.02). Independent predictors of CV mortality in the multivariable model were age, female gender, CRP titers, hypertension, smoking, and diabetes. Social class (insurance, income and education level) and total infection burden, quartiles 2 (p = 0.1), 3 (p = 0.4) and 4 (p = 0.1) were not predictive of CV mortality when keeping quartile 1 as the referent. Conclusion: Our observational study in a large database suggests that presence of antibodies against certain viral and parasitic infections is not associated with increased cardiovascular mortality in a nationally representative cohort.

Background: High Risk Percutaneous Coronary Intervention (PCI) is increasingly being performed with the availability of hemodynamic support. The aim of this study was to determine the predictors of length of stay (LOS) for high risk PCI in US. Methods: We explored the Healthcare Cost and Utilization Project’s Nationwide Inpatient Sample (NIS) using the ICD9 procedure code of 36.07 and 36.06 for PCI. NIS is largest all-payer dataset that represents 20% of all US hospitals. We included patients who had PCI from 2005 through 2010 who also underwent Percutaneous Circulatory Assist Device (PCAD) or Intra-aortic Balloon Pump (IABP) placement during the same hospital admission. Severity of comorbidities was defined by Deyo modification of Charlson’s Comorbidity Index (CCI). Hospitals were identified by a unique hospital identification number and hospital volume was determined by calculating the total number of PCI performed by an institution on year to year basis. Complications were based on Patient Safety Indicators (PSI) recognized by Agency for Health Care Research and Quality to monitor in hospital complications. We examined the predictors of LOS by a mixed effects linear regression model including patient demographics, admission characteristics, CCI quartiles with first quartile as a reference, hospital PCI volume quartiles, IABP or PCAD use and periprocedural complications. Hospital ID was incorporated as random effects in the model. Results: A total of 26,300 High Risk PCIs (weighted n = 130,151) were available for analysis. Factors associated with increased LOS were the use of IABP as compared to PCAD (+0.86 days, p=0.03), occurrence of any complication (+4.67 days, P < 0.001), high CCI (+2.5 days for CCI=2 and +4.1 days for CCI≥3, p Conclusion: In our observational study based on a large database, use of IABP as compared to PCAD, occurrence of complications, CCI, teaching hospital, presence of MI or shock and high PCI volume were associated with increased LOS & having private insurance and self pay or no insurance was associated with decreased LOS.

Background: Utilization of balloon aortic valvulopasty (BAV) has increased in recent years. We aimed to explore the relationship between hospital and operator experience on mortality. Methods: We queried Healthcare Cost and Utilization Project’s Nationwide Inpatient Sample (NIS) between 1998 and 2010 using the ICD9 procedure code of 35.96 for valvuloplasty. The NIS represents 20% of all hospitals in the US. Patients with age > 60years with aortic stenosis were included and those with concomitant mitral, tricuspid or pulmonic stenosis were excluded. Severity of co-morbid conditions was defined with Deyo modification of Charlson’s comorbidity index. Primary outcome was in-hospital mortality. Annual operator and hospital procedure volume were calculated based on the unique operator and hospital identification numbers and were split into tertiles of the total volume per year. Mixed effects logistic regression modeling incorporating hospital ID as random effects was constructed to find out the independent predictors of in-hospital mortality. Results: A total of 2,127 BAV (weighted n= 9,686) were identified for hospital volume analysis and 1,030 BAV (weighted n = 5,125) were available for both operator and hospital volume analysis. In models incorporating either operator or hospital volume alone (hazard ratio (HR), 95% CI, p value) both operator volume (HR 0.5 per every unit increase in operator volume, 0.3-0.9, p Conclusion: We demonstrated that both annual operator and hospital procedure volume significantly impact in-hospital mortality for BAV, with operator volume playing a more significant role.

Background: Limited data is available on health care cost of balloon aortic valvuloplasty (BAV). We analyzed trends and predictors of cost for BAV over the last decade (2001-2010). Methods: The analysis is based on Healthcare Cost and Utilization Project’s Nationwide Inpatient Sample (NIS) between 2001 and 2010 using the ICD9 procedure code of 35.96 for valvuloplasty. Only patients with age > 60 years with aortic stenosis were included & those with concomitant mitral, tricuspid or pulmonic stenosis were excluded. NIS represents 20% of all hospitals in US. We examined selective contribution of patient demographics, hospital characteristics, Charlson Comorbidity Index (CCI) and peri-procedural complications to hospitalization cost by using mixed effects linear regression modeling. For each year, cost was adjusted for inflation according to 2010 cost. Operator & hospital volume were calculated based on the unique operator and hospital identification numbers. Operator volume data were available for only 50% of the population. Results: Total 1,525 (weighted n = 7,595) BAV were performed from 2001 to 2010 with available cost data. Weighted cost of hospitalization for BAV increased from $21,562 in 2001 to $29,559 in 2010 (p for trend < 0.001). In a multivariable model including operator volume, 748 (weighted n = 3,708) BAV were available for analysis. The independent predictors of increased cost of hospitallization were occurrence of periprocedural complications ($22,509; p < 0.001), unstable patient, defined as having ICD-9 code for shock or ventilator dependence ($24,856; p < 0.001) and weekend admission ($11,416; p=0.002). Predictors of decreased cost for BAV were increase in operator volume (-$1,929 per every unit increase, p = 0.006). Increase in hospital valvuloplasty volume (-$1,644 per every 10 units increase, p = 0.2) showed a trend of decreasing cost, but this was statistically non-significant. Conclusion: In our current observational study we identified peri-procedural complications, unstable patient & weekend admission to be associated with increased cost & increase in operator volume to be associated with decreased cost of hospitalization for BAV. We also found a significant trend of increase in cost of hospitalization from 2001 to 2010.

To determine the impact of suture-mediated vascular closure devices (VCDs) on net adverse clinical events (NACEs) after balloon aortic valvuloplasty (BAV).Ischemic and bleeding complications are common following transfemoral BAV; however, previous studies have been single center and limited by varying definitions of major bleeding.The Effect of Bivalirudin on Aortic Valve Intervention Outcomes (BRAVOs) study was a retrospective observational study conducted at two high-volume academic centers over a 6-year period designed to compare the effect of bivalirudin versus unfractionated heparin. This is a subanalysis of 428 consecutive patients who underwent BAV (with 10-13 French sheaths) to compare the effect of hemostasis with VCDs versus manual compression utilizing standardized definitions. NACE was defined as the composite of major bleeding and major adverse clinical events (MACEs). All events were adjudicated by an independent clinical events committee who were blinded to antithrombin use.Preclosure was performed in 269 (62.8%) of patients. While bivalirudin was used more frequently in those with pre-closure (60.6% vs. 37.7%, P0.001), a history of prior BAV (11.1% vs. 3.6%, P = 0.04) and peripheral vascular disease (30.7% vs. 19.7%, P = 0.01) was more common in those not undergoing preclosure (n = 159, 37%). Other clinical and demographic features were well balanced between groups. Vascular closure was associated with a significant reduction in NACE (24.5% vs. 10.0% P0.001). Results remained significant after adjusting for baseline differences and bivalirudin use (OR 0.38, 95% CI: 0.21-0.68; P = 0.001).Our study suggests that suture-mediated vascular closure is associated with a substantial reduction in NACE after transfemoral BAV. Large randomized clinical trials should be conducted to confirm our results.

Higher Body Mass Index (BMI) is associated with decreased mortality in heart failure patients; a phenomenon termed the ‘Obesity Paradox’. This meta-analysis aims to evaluate BMI (kg/m2) as a predictor of 1-year mortality in patients with acute coronary syndromes (ACS). We searched MEDLINE using

Drug Eluting Stents (DES) decrease in stent re-stenosis by about 80% when compared to Bare Metal Stents (BMS). Racial disparities have been reported in the use of cardiovascular procedures. We explore such disparities in Florida. We conducted a cross-sectional analysis of all stent procedures

Heart failure (HF) is associated with a high incidence of stroke. The role of warfarin or aspirin in reducing this burden remains unclear. We searched MEDLINE (1966–10/2012), WEB OF SCIENCE (1980–10/2012), The Cochrane Library (Central and Dare) (Issue 10, 2012). We also searched BIOSIS (1969

Transcatheter Aortic Valve Replacement (TAVR) improves survival in inoperable patients with severe aortic stenosis (AS). Compared to surgical aortic valve replacement (AVR), TAVR is associated with a higher incidence of paravalvular leaks. The aortic regurgitation (AR) index has been shown to be

Transcatheter aortic valve implantation (TAVI) has emerged as a therapeutic alternative for patients with symptomatic aortic stenosis at high or prohibitive surgical risk. However, patients undergoing TAVI are also at high risk for both bleeding and stroke complications, and specific mechanical aspects of the procedure itself can increase the risk of these complications. The mechanisms of periprocedural bleeding complications seem to relate mainly to vascular/access site complications (related to the use of large catheters in a very old and frail elderly population), whereas the pathophysiology of cerebrovascular events remains largely unknown. Further, although mechanical complications, especially the interaction between the valve prosthesis and the native aortic valve, may play a major role in events that occur during TAVI, post-procedural events might also be related to a prothrombotic environment or state generated by the implanted valve, the occurrence of atrial arrhythmias, and associated comorbidities. Antithrombotic therapy in the setting of TAVI has been empirically determined, and unfractionated heparin during the procedure followed by dual antiplatelet therapy with aspirin (indefinitely) and clopidogrel (1 to 6 months) is the most commonly recommended treatment. However, bleeding and cerebrovascular events are common; these may be modifiable with optimization of periprocedural and post-procedural pharmacology. Further, as the field of antiplatelet and anticoagulant therapy evolves, potential drug combinations will multiply, introducing variability in treatment. Randomized trials are the best path forward to determine the balance between the efficacy and risks of antithrombotic treatment in this high risk-population.

Transradial access may be advantageous for patients with end-stage liver disease (ESLD) who need to undergo left heart catheterization (LHC). We aimed to assess the safety of transradial cardiac catheterization in patients listed for orthotopic liver transplantation.This is a retrospective analysis of consecutive adult patients with the diagnosis of ESLD, who underwent LHC via transradial access as part of a pre-operative liver transplantation evaluation. All the patients also underwent right heart catheterization (RHC) via brachial or femoral vein. The primary outcome measure was procedure-related major bleeding. Secondary outcomes included access site minor bleeding, in-hospital mortality, radial access failure, and acute kidney injury.A total of 82 consecutive patients with ESLD, who underwent LHC via transradial access, were enrolled in the study. All patients also underwent RHC (n = 45 via brachial and n = 37 via femoral vein). The median age was 59 (54, 67) years old, and 58% were male. History of coronary artery disease or heart failure was present in 17% of patients. The median MELD score was 19 (13, 24.5), baseline hemoglobin was 10.5 mg/dL (9.4, 11.8), INR was 1.4 (1.2, 1.8) and platelets were 74,000 (53,000, 117,000)/mm(3) . The most common etiology of liver failure was viral hepatitis (51%), followed by alcoholic cirrhosis (24%) and non-alcoholic steatohepatitis (21%). Angiographically significant coronary artery disease was present in 17 (21%) patients. Major bleeding and acute kidney injury each occurred in two patients (2.4%). There were no instances of vascular complications. There were no deaths attributable to complications from cardiac catheterization.Upper extremity right and left heart catheterization appears to be a safe method to evaluate coronary anatomy and hemodynamics in a severely ill population of patients with ESLD awaiting transplant.

Transcatheter aortic valve replacement (TAVR) has become an alternative intervention in high-risk and inoperable patients with symptomatic aortic valve stenosis. The procedure has been associated with favorable clinical outcomes and safety profile in patients with end stage renal disease (ESRD). We describe a case of improved kidney function in a patient with ESRD without further need for dialysis after TAVR.

Objectives To assess the impact of the Centers for Medicare and Medicaid Services (CMS) national coverage determination (NCD) on access for patients with aortic stenosis (AS) with transcatheter aortic valve replacement (TAVR) in a tertiary care center. Background TAVR has given hope to patients with AS who are deemed inoperable. The effects of the NCD on access to patients with AS has not been evaluated. Materials and Methods A total of 94 inoperable AS patients were evaluated and treated from December 2011 through June of 2012 with TAVR. Patients who underwent transfemoral (TF) vs. non-TF access were compared. The CMS NCD was released on May 1, 2012 and on July 1, 2012, the nontransfemoral access program was put on hold due to lack of reimbursement. Results Patients in the TF (n = 33) and non-TF access (n = 61) groups were similar in age (85.2 ± 6.3 vs. 84.8 ± 6.6 P = 0.74) and STS mortality (9.38 ± 5.33 vs. 7.91 ± 3.69, P = 0.074). The iliofemoral arteries were larger diameter in the TF group (7.72 ± 1.49 vs. 6.21 ± 1.78, P < 0.001) and males (7.39 ± 1.81 vs. 6.1 ± 1.61 P < 0.001). More women underwent valve implantation via non-TF access (73 vs. 23%, P = 0.03). After the NCD, 21 patients who previously qualified for non-TF TAVR would not be reimbursed by CMS. Four died soon after. Conclusions After the NCD, the proportion of inoperable patients with severe AS that can be treated with TAVR was greatly reduced due the lack of reimbursement for TAVR via non-TF access. This effect is particularly pronounced in women. © 2014 Wiley Periodicals, Inc.

The Centers for Medicare & Medicaid Services (CMS) requires maintaining ≥400 percutaneous coronary intervention (PCI) every year for hospital program with transcatheter aortic-valve replacement (TAVR) experience. However, it is uncertain whether or not a higher PCI volume is needed to optimize

Transcatheter aortic valve replacement (TAVR) in combination with percutaneous coronary intervention (PCI) has emerged as a less invasive and feasible therapeutic option for this high surgical risk patient population with AS and CAD. The aim of this study is to determine the outcomes of TAVR when

The 2015 cardiopulmonary resuscitation and emergency cardiovascular care guidelines recommend performing coronary angiography in resuscitated patients after cardiac arrest with or without ST-segment elevation (STE).To assess the temporal trends, predictors, and outcomes of performing coronary angiography and percutaneous coronary intervention (PCI) in patients resuscitated after out-of-hospital cardiac arrest (OHCA) with initial rhythms of ventricular tachycardia or pulseless ventricular fibrillation (VT/VF).An observational analysis of the use of coronary angiography and PCI in 407 974 patients hospitalized after VT/VF OHCA from January 1, 2000, through December 31, 2012, from the Nationwide Inpatient Sample database. Multivariable analysis was used to assess factors associated with coronary angiography and PCI use. Data analysis was performed from December 12, 2015, to January 5, 2016.Temporal trends of coronary angiography, PCI, and survival to discharge in patients with VT/VF OHCA.Among the 407 974 patients hospitalized after VT/VF OHCA, 143 688 (35.2%) were selected to undergo coronary angiography. The mean (SD) age of the total population was 65.7 (14.9) years, 37.9% were female, and 74.1% were white, 13.4% black, 6.8% Hispanic, and 5.7% other race. Use of coronary angiography increased from 27.2% in 2000 to 43.9% in 2012 (odds ratio, 2.47; 95% CI, 2.25-2.71; P for trend .001), and PCI increased from 9.5% in 2000 to 24.1% in 2012 (odds ratio, 4.80; 95% CI, 4.21-5.66; P for trend .001). From 2000 to 2012, coronary angiography and PCI after VT/VF OHCA increased in patients with STE (53.7% to 87.2%, P for trend .001, and 29.7% to 77.3%, P for trend .001, respectively) and those without STE (19.3% to 33.9%, P for trend .001, and 3.5% to 11.8%, P for trend .001, respectively). There was an associated increasing trend in survival to discharge in the overall population of patients with VT/VF OHCA (46.9% to 60.1%, P for trend .001) in those with STE (59.2% to 74.3%, P for trend .001) or without STE (43.3% to 56.8%, P for trend .001).Coronary angiography, PCI, and survival to discharge have increased in VT/VF OHCA survivors from event to hospitalization. However, a significant proportion of patients with VT/VF OHCA, especially those without STE, do not undergo coronary angiography and revascularization. Prospective studies are needed to determine whether this limitation has a survival effect.

Patients with atrial fibrillation (AF) presenting with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) remain a challenging group of patients. With the use of the Nationwide Inpatient Sample, we identified all patients hospitalized with a principal diagnosis of

We aim to evaluate the health care associated cost of Sudden Cardiac Death (SCD) in the United States. We used the US National Inpatient Sample (2003 to 2012) to identify patients with SCD. Total health care inflation adjusted cost was the primary outcome. Overall, an estimated 1,387,396 patients

Cirrhotic patients are considered a high risk group for coronary revascularization. We assessed in-hospital mortality in these patients with myocardial infarction (MI) undergoing coronary revascularization. We used the National Inpatient Sample from 2003-2012 to identify cirrhotic patients with MI

The 2013 ACC/AHA/SCAI clinical competence statement for PCI reduced the recommended minimum number of PCI procedures performed annually by each operator to 50 in an attempt to accommodate lower PCI volumes over the past decade. Temporal and geographic patterns of operator PCI volume are unknown.

To assess the feasibility and outcomes in patients undergoing transvenous transseptal (TS) transcatheter aortic valve replacement (TAVR).TS approach for TAVR was abandoned in favor of retrograde transfemoral, transaortic, or transapical approaches. TS TAVR may still be warranted in patients for whom no other approach is feasible.Observational consecutive case series at a single center, to evaluate technical outcomes in inoperable patients with aortic stenosis who had contraindications for other approaches and who underwent TAVR via a transvenous TS antegrade approach using the Edwards-Sapien (ES) valve.Over a 4-month period, 9 patients underwent TS TAVR with 26 mm (n = 4) and 23 mm (n = 5) ES valves. Mean age was 84.5 ± 6.6 years and Society of Thoracic Surgeons predicted risk of mortality was 7.8 ± 2.8%. Specific contraindications for other access included iliofemoral arterial diameter7 mm in 9 (100%), porcelain aorta in 6 (66%) patients, multiple (≥2) sternotomies in 2 (22%) patients, severe pulmonary disease in 3 (33%), extreme frailty in 1 (11%), spinal stenosis with impaired ability to rehabilitate postsurgery in 1 (11%) and apical left ventricular thrombus in 1 (11%) patient. Antegrade deployment of the ES prosthetic valve was technically feasible in 8 patients. Major bleeding occurred in 4 patients, two patients suffered acute kidney injury without need for dialysis and one patient required a permanent pacemaker. The median (25th, 75th percentiles) fluoroscopy time was 49 (34, 81) minutes and contrast volume was 150 (120, 225) ml. No patient had hemodynamically significant post-TAVR aortic insufficiency nor damage to the mitral valve. At 6 months follow-up, there were no cerebrovascular events or rehospitalizations and mean NYHA Class improved from 3.4 to 1.7.The antegrade TS approach to TAVR is a technically feasible option for "no-access" patients. Prospective assessment of the safety and efficacy of this approach in the current era warrants further study.

This study sought to investigate the technical feasibility and safety of the transaortic (TAO) transcatheter aortic valve replacement (TAVR) approach in patients not eligible for transfemoral (TF) access by using a device commercially available in the United States.A large proportion of candidates for TAVR have inadequate iliofemoral vessels for TF access. The transapical route (TAP) is the current alternative but is associated with less favorable outcomes. Other access options need to be explored.Forty-four consecutive patients with inoperable, severe aortic stenosis underwent TAO TAVR in our institution. Procedural and 30-day clinical outcomes data were compared with data from 76 consecutive patients who underwent TAP TAVR at our site. Technical learning curves were assessed by comparing outcomes of the first 20 cases with the subsequent patients who underwent each procedure.The TAO and TAP TAVR groups were similar in terms of device success according to Valve Academic Research Consortium criteria (89% vs. 84%; p = 0.59) and rates of the 30-day combined safety endpoint of all-cause mortality, myocardial infarction, major stroke, disabling bleeding, severe acute kidney injury, and valve reintervention (20% vs. 33%; p = 0.21). The TAO approach, compared with TAP TAVR, was associated with lower combined bleeding and vascular event rate (27% vs. 46%; p = 0.05), shorter median intensive care unit length of stay (3 vs. 6 days; p = 0.01), and a favorable learning curve.TAVR via the TAO approach is technically feasible, seems to be associated with favorable outcomes, and expands the current alternative options for access sites in patients with inoperable aortic stenosis who are ineligible for TF TAVR.

We aimed to assess the additive value of electrocardiogram (ECG) findings to risk prediction models for cardiovascular disease.Our dataset consisted of 6025 individuals with ECG data available from the National Health and Nutrition Examination Survey-III. This is a self-weighting sample with a follow-up of 79,046.84 person-years. The primary outcomes were cardiovascular mortality and all-cause mortality. We compared 2 models: Framingham Risk Score (FRS) covariates (Model A) and ECG abnormalities added to Model A (Model B), and calculated the net reclassification improvement index (NRI).Mean age of our study population was 58.7 years; 45.6% were male and 91.7% were white. At baseline, 54.6% of individuals had ECG abnormalities, of which 545 (9%) died secondary to a cardiovascular event, compared with 194 individuals (3.2%) (P.01) without ECG abnormalities. ECG abnormalities were significant predictors of cardiovascular mortality after adjusting for traditional cardiovascular risk factors (hazard ratio 1.44; 95% confidence interval, 1.13-1.83). Addition of ECG abnormalities led to an overall NRI of 3.6% subjects (P.001) and 13.24% in the intermediate risk category. The absolute integrated discrimination index was 0.0001 (P.001).Electrocardiographic abnormalities are independent predictors of cardiovascular mortality, and their addition to the FRS improves model discrimination and calibration. Further studies are needed to assess the prospective application of ECG abnormalities in cardiovascular risk prediction in individual subjects.

Antithrombotic agents including anticoagulants and antiplatelets are the cornerstone of treatment of acute coronary syndromes. Currently available anticoagulants have several important limitations including unpredictable pharmacodynamics, immunogenicity, and difficulty in reversibility. A potent anticoagulant that has predictable efficacy, is easily reversible should the clinical need arise, and reduces ischemic events without an increase in bleeding risk would overcome many of the current limitations. Inhibition of factor IX in the coagulation cascade has shown promise as a target for development of a novel anticoagulant with a favorable bleeding risk. Aptamers are small oligonucleotides that can be developed to inhibit specific protein targets with high affinity and used as active drugs. Because aptamers are made of oligonucleotide sequences, they provide the code for their own complement (reversal agent) that can be developed and used to inhibit their function. The REG1 anticoagulation system is a novel, aptamer-based, factor IXa inhibitor that is being developed for use in patients undergoing percutaneous coronary intervention and the treatment of acute coronary syndrome.

Background With the expansion in the use of transcatheter valve therapies for aortic stenosis, the incidence of hemodynamically significant paravalvular regurgitation (PVR) has become a clinical challenge. Methods The study population consisted of those patients with either acute significant PVR immediately post-Edwards SAPIEN (ES) aortic valve implantation, requiring additional maneuvers during the index transcatheter aortic valve replacement (TAVR) or symptomatic PVR requiring treatment by transcatheter closure at a later date. All the patients were assessed within 24 hrs, 30 days, 3 months, 6 months and 12 months after the procedure. Results A total of 100 consecutive patients underwent ES TAVR (62% with 23 mm and 38% with 26 mm valve), of them 27% (27/100) were identified to have hemodynamically significant PVR requiring additional percutaneous interventions during or after the index procedure. Patient's mean age was 85 ± 12 years and 74% (20/27) were male. The mean Society of Thoracic Surgeon Score was 11.3% (range 4.6–17.6%), 59% had a 23 mm and 41% had a 26 mm ES valve. There was no difference in the occurrence of PVR between a) two valve sizes—23 mm (16/62) vs. 26 mm (11/38) (P = 0.817) and b) the two approaches—transfemoral (15/48) vs. transapical (TA) (12/52) (P = 0.37). A total of 32 procedures were performed on the 27 patients: one patient required four and two required two procedures each. There were 19 repeat ballooning, seven valve in valve and six transcatheter device closure procedures. The approach was retrograde in 66%, antegrade transeptal in 6% and antegrade TA in 28%. The procedural success rate was 90.6%, the total 30-day, 3 months and 6 months mortality rate was 7.4, 18.5, and 22% respectively. At the time of final analysis a total of 56% (15/27) had completed a 12 month follow-up. Conclusion The management of PVR in the TAVR era is a technical challenge. We present our experience and propose a management approach. © 2013 Wiley Periodicals, Inc.

Most clinicians regard isolated, minor, or nonspecific ST-segment and T-wave (NS-STT) abnormalities to be incidental, often transient, and benign findings in asymptomatic patients. We sought to evaluate whether isolated NS-STT abnormalities on routine electrocardiograms (ECGs) are associated with increased risk of cardiovascular mortality (CM) and all-cause mortality (AM) in a cross-sectional United States population without known coronary artery disease. We included all adults 40 to 90 years of age without known coronary artery disease or risk equivalent based on history and laboratory values, enrolled in the NHANES III from 1988 to 1994, with electrocardiographic data available, and a total follow-up period of 59,781.75 patient-years. NS-STT abnormalities were defined by Minnesota Coding. Subjects were excluded if their mortality data were missing or if they had major electrocardiographic abnormalities, heart rate >120 beats/min, nonsinus rhythm, cardiac infarction/injury score ≥ 20 on ECG, left ventricular hypertrophy by Minnesota Codes 3.1 and 3.3, or patient-reported history coronary artery disease, congestive heart failure, stroke, diabetes, or peripheral arterial disease. The remaining 4,426 subjects were stratified by presence or absence of NS-STT abnormalities. Mortality was judged based on International Classification of Diseases, Tenth Revision coding linked to the National Death Index. Cox proportional hazard ratio was used for multivariate analysis, showing that CM (hazards ratio 1.71, 95% confidence interval 1.04 to 2.83, p = 0.04) and AM (hazards ratio 1.37, 95% confidence interval 1.03 to 1.81, p = 0.02) were significantly higher in the isolated NS-STT abnormalities group. In conclusion, isolated NS-STT abnormalities on ECG were associated with a higher incidence of CM and AM in this large nationally representative cross-sectional cohort without known coronary artery disease or coronary artery disease risk equivalents.

Background: Ethnic differences have been reported in the treatment and outcomes of patients with non-ST-segment elevation myocardial infarction (non-STEMI). Potential ethnic disparities in contemporary STEMI management have not been well characterized. Methods: We compared practice patterns and outcomes between 1,654 Hispanics (H) (4.1%) and 38,844 non-Hispanic Whites (NHW) treated for STEMI in ACTION Registry-GWTG between 01-2007 and 03-2009. Logistic generalized estimating equation modeling was used to examine associated risk-adjusted mortality. Results: Hispanic patients more frequently had diabetes (32% vs 21%, p Conclusions: Despite similar in-hospital mortality, Hispanic STEMI patients had significant differences in process of care with longer triage and treatment delays than non-Hispanic Whites. As the fastest growing minority in the United States, this population needs further efforts to optimize their care processes Hispanics Non-Hispanic Whites p value Ambulance use 41.5% 47.0% Pre-Hospital EKG 32.8% 37.5% Onset of pain to arrival (median) 2.0 hrs 1.6 hrs Arrival to EKG (median) 8 min 6 min Arrival to EKG 61.2% 69.3% Reperfusion therapy 91.6% 93.1% 0.04 Arrival to PCI (median) 74 min 69 min DTB 69.4% 77.5%

Refractory angina is a major clinical challenge in ­contemporary cardiovascular medicine. As therapeutic strategies evolve, there is increased life expectancy for ischemic heart disease with more patients reaching advanced stages. Due to a better understanding of the disease process and technological advances, coronary revascularization, by means of coronary by-pass grafting (CABG) and percutaneous coronary interventions (PCI), is now offered to a wide spectrum of high-risk patients. The inception of drug eluting stents in routine clinical practice has reduced the restenosis rates to single digits [1, 2], extending the indications of PCI to poor operative candidates with unprotected left main stenosis or diabetics with diffuse small vessel disease. In a similar fashion, more generalized use of major surgical revascularization breakthroughs, such as off-pump CABG and arterial grafts, have resulted in significant improvements in surgical outcomes [3]. Despite these advances, a significant proportion of patients with preserved left ventricular fraction and no life-threatening arrhythmias remain symptomatic with severe debilitating angina due to progression of native atherosclerotic disease associated with failure or unfeasibility of revascularization. In a prospective observational study, Hemingway et al. showed that at 1-year follow-up angina persists in 52% of patients treated with PCI and 40% of those treated with CABG [4]. Similar findings were observed in the multicenter international ARTS randomized trial, in which only 19% of PCI patients and 38% of CABG patients were free of angina and antianginal therapy at 1-year follow-up [5]. Moreover, in a meta-analysis of 11 randomized trials comparing PCI with medical therapy in stable patients with chronic coronary artery disease, PCI offered no survival benefit [6].

Objectives To evaluate feasibility and technical outcomes in patients with aortic stenosis (AS) who have undergone high-risk procedures with continuous flow left ventricular (LV) assist, with the Impella 2.5 system (Abiomed, Danvers, MA). Background In preparation for transcatheter aortic valve implantation, an increasing number of high-risk patients with severe AS and left ventricular dysfunction are currently considered for percutaneous coronary interventions (PCI) and balloon aortic valvuloplasty (BAV). Hemodynamic support may be required in some patients. Methods We reviewed procedural and clinical findings and 30-day outcomes in patients with symptomatic AS who underwent high-risk percutaneous procedures supported by the Impella 2.5 system. All patients carried a high-risk of operative mortality. Impella was used during PCI, BAV, and for hemodynamic support during emergencies. Results Over a 14-month period, 21 patients with AS underwent insertion of Impella prior to high-risk PCI (n = 3), BAV with subsequent PCI (n = 8), BAV alone (n = 7), or during cardiac arrest immediately following BAV (n = 3). The mean Society of Thoracic Surgeons (STS) predicted mortality risk was 14% (range 7.3–24.7%). Impella was inserted successfully in all patients attempted. Retrograde advancement of two catheters across the aortic valve (for concomitant BAV in 15 patients) was technically feasible. Retrograde continuous flow LV assist produced a reduction in LV end-diastolic pressure and an increase in arterial pressure. Periprocedural complications occurred in 19% (n = 4) patients, with no periprocedural deaths. Mortality at 30 days was 14.2%. Conclusion Our data suggests that continuous flow LV assist with Impella 2.5 can be used in high-risk patients with severe AS who require periprocedural hemodynamic support. © 2012 Wiley Periodicals, Inc.

Cardiovascular Division, Department of Medicine,University of Miami Miller School of Medicine,Miami, FloridaThe development of temporary percutaneous leftventricular assist devices (TPLVAD) is perceived as animportant step forward in the care of patients with car-diogenic shock and patients with extensive coronaryartery disease, low ejection fraction, and multiplecomorbidities whose only revascularization option ispercutaneous coronary intervention (PCI). The preva-lence of cardiogenic shock has remained stable atapproximately 7% in ST-elevation myocardial infarc-tion over the past 30 years. The mortality remains high(>50%) despite a better understanding of inotropictherapies and widespread use of intraaortic balloonpumps (IABP) [1]. To date, there are only moderate-to-small randomized and observational studies investi-gating TPLVAD, due to the select nature of the targetpopulation, the complexities associated with their useand monitoring, and their high cost.In this issue of the Journal, Froesch et al. [2] presenttheir single center experience with the use of TPLVADin a retrospective analysis of 75 patients with cardio-genic shock (n549) and high risk PCI (n526). Inter-estingly, TandemHeart was more likely to be used incardiogenic shock compared with Impella, which wasmore frequently used to support high-risk PCI. This isnot surprising as TandemHeart can fully support circu-lation in the most extreme cases. The authors reporteda high 6-month mortality of 23% in the high-risk PCIgroup and 55% in the shock group. The overall devicecomplication rate was as high at 36% (more than 1 in3), with a staggering 43% in the shock group. Thesefigures may represent selection bias, as operators tendto favor the use of TPLVAD in cases of advanced re-fractory shock with profound hypotension and systemicinflammatory response that are unlikely to respond toIABP support.The feasibility of use and superior hemodynamicsassociated with TPLVAD in high-risk PCI aresupported by previous data [3–5]. The recently pre-sented PROTECT II trial, randomized a unique high-risk PCI patient population to IABP versus Impella2.5. After an interim analysis with 324 patients, thetrial was stopped for futility. However, the final resultsincluding 447 patients showed an intriguing 21%reduction in major adverse events at 90 days withImpella compared with IABP (40.8% vs 51.4%,p50.029), mostly driven by a decrease in repeat revas-cularization procedures. Impella support provided bet-ter hemodynamic stability during PCI allowing opera-tors to perform longer procedures with more aggressiveuse of rotational atherectomy [6].The survival benefit of TPLVAD over IABP is yetto be established in patients with cardiogenic shock[7]. Previous studies have shown that hemodynamicparameters are consistently improved with TPLVAD[7–10]. The ongoing IMPRESS in STEMI trial, inves-tigating Impella 2.5 versus IABP for large anteriorwall STEMI with high clinical risk, will hopefully pro-vide a more definitive answer to this question [11].TPLVAD insertion and use is more complex thanIABP. TPLVAD work best in the hands of skilledoperators with expertise in the management of largesize catheters and transseptal puncture for thepositioning of the left atrial cannula in the case ofTandemHeart. In addition, catheterization laboratorypreparedness and well-trained staff are essential for theoptimal use and minimization of complications associ-ated with TPLVAD. Science is replete with exampleswhere proof of concept and expert consensus does notnecessarily translate into clinical benefit. On the otherhand clinical practice is even more replete with exam-ples where inconclusive results do not easily dissuadea steadfast clinician convinced about the benefit of anintervention. The registry data presented in this issueof the Journal provides useful information to betterunderstand the clinical use of TPLVAD [2]. However

We performed detailed pharmacokinetic and pharmacodynamic modeling of REG1, an anticoagulation system composed of the direct factor IXa (FIXa) inhibitor pegnivacogin (RB006) and its matched active control agent anivamersen (RB007), with a focus on level of target inhibition to translate phase 1 results to phase 2 dose selection. We modeled early-phase clinical data relating weight-adjusted pegnivacogin dose and plasma concentration to prolongation of the activated partial thromboplastin time (aPTT). Using an in vitro calibration curve, percent FIXa inhibition was determined and related to aPTT prolongation and pegnivacogin dose and concentration. Similar methods were applied to relate anivamersen dose and level of reversal of pegnivacogin anticoagulation. Combined early-phase data suggested that ≥0.75 mg/kg pegnivacogin was associated with >99% inhibition of FIX activity and prolongation of plasma aPTT values ≈2.5 times above baseline, leading to selection of a 1 mg/kg dose for a phase 2a elective percutaneous coronary intervention study to achieve a high intensity of anticoagulation and minimize intersubject variability. Phase 2 validated our predictions, demonstrating 1 mg/kg pegnivacogin yielded plasma concentrations ≈25 μg/ml and >99% inhibition of FIX activity. The relationship between the anivamersen to pegnivacogin dose ratio and degree of pegnivacogin reversal was also validated. Our approach decreased the need for extensive dose–response studies, reducing the duration, complexity and cost of clinical development. The 1 mg/kg pegnivacogin dose and a range of anivamersen dose ratios are being tested in the phase 2b RADAR study (NCT00932100).

In 1986, Cribier et al. attempted the first percutane-ous transluminal balloon aortic valvuloplasty (BAV) inthree elderly patients with severe symptomatic aorticstenosis [1]. This was followed by a number of largerstudies that showed low early mortality after BAV, buthigh rates of late restenosis without changing the natu-ral history of aortic stenosis. Between 1988 and 1994,outcomes for palliative BAV were reported [2,3]. Morethan half of the late cardiac deaths were found inpatients with reduced left ventricular ejection fraction(LVEF) and extensive coronary artery disease. Duringthe subsequent decade, the procedure was almost aban-doned and only indicated as a bridge to surgical aorticvalve replacement (SAVR). After the inception oftranscatheter valve therapies for high-risk and inoper-able patients, the use of BAV increased steadily, withimproved procedural outcomes, especially when per-formed by experienced operators. Even though BAV isassociated with higher complication rates in extremerisk patients with severe systolic dysfunction, these arethe patients most likely to derive the greatest benefitthrough improved functional capacity, left ventricularfunction recovery, and a reduction in the severity ofconcomitant mitral regurgitation.In this issue, Pedersen et al. described the outcomesof 16 extreme-risk patients with low LVEF (

We present a case of an 83-year-old female with past medical history of rheumatic fever associated mitral stenosis for which she underwent mitral commissurotomy 25 years prior to presentation. Subsequently, she underwent coronary artery bypass grafting and mitral valve replacement with a bio-prosthetic valve 8 years prior to presentation. Presently, she started experiencing worsening dyspnea and heart failure symptoms. Echocardiography showed mildly reduced left ventricular ejection fraction with severe aortic stenosis and pulmonary hypertension. The bioprosthetic mitral valve was functioning normally. We performed right and left heart catheterization for evaluation. Peak aortic gradient was 50 mm Hg with a mean gradient of 39 mm Hg. Aortic valve area was calculated to be 0.31 cm2. However, simultaneous measurement of left ventricular and wedge pressures showed a significant gradient of 11 mm Hg across the mitral valve with a calculated mitral valve area of 0.4 cm2. Because of discordant information between echocardiographic and hemodynamic data, we proceeded with trans-septal puncture to directly measure left atrial pressures. Simultaneous left atrial and left ventricular pressure measurement demonstrated a mean gradient of 4 mm Hg across the mitral valve with an area calculated at 1.9 cm2. We review the tracings in detail and discuss the pitfalls of using pulmonary capillary wedge pressure as a surrogate for left atrial pressure. © 2011 Wiley Periodicals, Inc.

Background— The ideal anticoagulant should prevent ischemic complications without increasing the risk of bleeding. Controlled anticoagulation is possible with the REG1 system, an RNA aptamer pair comprising the direct factor IXa inhibitor RB006 and its active control agent RB007. Methods and Results— This phase 2a study included a roll-in group (n=2) treated with REG1 plus glycoprotein IIb/IIIa inhibitors followed by 2 groups randomized 5:1 to REG1 or unfractionated heparin. In group 1 (n=12), RB006 was partially reversed with RB007 after percutaneous coronary intervention and fully reversed 4 hours later. In group 2 (n=12), RB006 was fully reversed with RB007 immediately after percutaneous coronary intervention. Femoral sheaths were removed after complete reversal. Patients were pretreated with aspirin and clopidogrel. End points included major bleeding within 48 hours; composite of death, myocardial infarction, or urgent target vessel revascularization within 14 days; and pharmacodynamic measures. All cases were successful, with final Thrombolysis in Myocardial Infarction grade 3 flow and no angiographic thrombotic complications. There were 2 ischemic end points in the REG1 group and 1 in the unfractionated heparin group, with 1 major bleed in the unfractionated heparin group. Median activated clotting time values rose from 151 to 236 seconds after RB006. Administration of the partial RB007 dose reversed anticoagulation to an intermediate activated clotting time value of 186 seconds. Complete reversal with RB007 returned the median activated clotting time value to 144 seconds. Both reversal strategies enabled scheduled femoral sheath removal. Conclusions— This study demonstrates the clinical translation of a novel platform of anticoagulation targeting factor IXa and its active reversal to percutaneous coronary intervention and provides the basis for further investigation. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00715455.

Anticoagulants are the cornerstone of current acute coronary syndrome (ACS) therapy; however, anticoagulation regimens that aggressively reduce ischemic events are almost uniformly associated with more bleeding. REG1, an anticoagulation system, consists of RB006 (pegnivacogin), an RNA oligonucleotide factor IXa inhibitor, and RB007 (anivamersen), its complementary controlling agent. Phase I and IIa studies defined predictable relationships between doses of RB006, RB007, and degree of antifactor IX activity. The efficacy and safety of REG1 for the treatment of patients with ACS managed invasively and the safety of reversing RB006 with RB007 after cardiac catheterization are unknown. Randomized, partially-blinded, multicenter, active-controlled, dose-ranging study assessing the safety, efficacy, and pharmacodynamics of the REG1 anticoagulation system compared to unfractionated heparin or low molecular heparin in subjects with acute coronary syndrome (RADAR) is designed to assess both the efficacy of the anticoagulant RB006 and the safety of a range of levels of RB006 reversal with RB007. The objectives of RADAR are (1) to determine the safety of a range of levels of RB006 reversal with RB007 after catheterization, (2) to confirm whether a dose of 1 mg/kg RB006 results in near-complete inhibition of factor IXa in patients with ACS, and (3) to assess the efficacy of RB006 as an anticoagulant in patients with ACS undergoing percutaneous coronary intervention.