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OBJECTIVES: Three-dimensional transesophageal echocardiography (TEE) is widely used to guide decision-making for mitral repair - relative impact of surgical mitral valve repair (MVr) and MitraClip on annular remodeling is unknown. The aim was to determine the impact of both mitral repair strategies on annular geometry, including the primary outcome of annular circumference and area. DESIGN: This was a retrospective observational study of patients who underwent mitral intervention between 2016 and 2020. SETTING: Weill Cornell Medicine, a single large academic medical center. PARTICIPANTS: The population comprised of 50 degenerative mitral regurgitation (MR) patients undergoing MVr. INTERVENTIONS: Elective MVr and transesophageal echocardiography (TEE) MEASUREMENTS AND MAIN RESULTS: MitraClip or surgical MVr patients were matched (1:1) for gender and CAD. Mitral annular geometry indices were quantified on intra-procedural 3D TEE. Mild or less MR on follow-up TTE defined optimal response. MitraClip patients were older (80±8 vs. 66±6;p

Background: New mild or persistent moderate paravalvular leak (PVL) is a known predictor of poor outcomes after transcatheter aortic valve replacement (TAVR). Its impact on left ventricular (LV) remodeling and global longitudinal strain (GLS) has not been well studied. Materials & methods: We collected echocardiographic data in 99 TAVR patients. LV remodeling and GLS were compared between patients with and without PVL. Results: Patients without PVL (n = 84) had significant LV ejection fraction, wall thickness and LV mass improvement compared with patients with PVL (n = 15; p

Background Coronary stenting without angioplasty pretreatment (direct stenting) may simplify procedures in appropriate lesions. Direct stenting is facilitated by smaller profile coronary stent platforms. The present study was designed for regulatory approval of a novel drug-eluting coronary stent and incorporates both randomized comparison for non-inferiority to an approved predicate device as well as a nested evaluation of subjects eligible for direct stenting. Study Design and Objectives. Prospective, single-blind, randomized, active-control, multi-center study designed to assess the safety and efficacy of the novel Svelte sirolimus-eluting stent (SES) systems. A total of 1630 subjects with up to 3 target lesions will be randomized 1:1 to the Svelte SES versus either the Xience or Promus everolimus-eluting stents (control). Randomization will be stratified by whether or not a direct stenting strategy is planned by the investigator. The primary endpoint is target lesion failure (TLF) at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a non-inferiority test with a non-inferiority margin of 3.58%. Secondary clinical endpoints include individual components of TLF, stent thrombosis and measures of procedural resource utilization including contrast administration, fluoroscopy exposure and procedural resource utilization as well as costs. Conclusion The OPTMIZE Trial will evaluate the safety, efficacy and clinical value of the novel Svelte SES in subjects with up to 3 lesions, and will provide a comparison of direct stenting between randomized devices.

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.

Although abdominal aortic aneurysms (AAA) are more common in men, women with AAA have increased morbidity and mortality. Additionally, there are discrepancies among professional society guidelines for AAA screening in women. In this retrospective study from the Nationwide Inpatient Sample (NIS) database from 2003 to 2014, we compared rates of AAA repair (rupture and elective) and AAA-related mortality in men vs. women to identify predictors of death among men and women with AAA. We divided the population into 1) AAA rupture 2) elective AAA repair. The main outcomes included temporal trends in AAA rupture, rupture-related death, AAA repair, in-hospital death, and predictors of AAA-related death. There were 570,253 discharge records for AAA admissions between 2003 and 2014, including 22.8% women and 77.2% men. Women had a higher proportion of rupture (18.4% vs 12.6%, p

Left atrial appendage (LAA) closure has recently been approved as an alternative management for stroke prevention in patients with chronic atrial fibrillation who have difficulties with long-term oral anticoagulation. The various shapes and sizes of LAA and orientation of the atrial ostium may contribute to the incomplete LAA closure from circular design devices and orientation of the non-steerable delivery catheter. Incomplete closure of LAA leads to a high-velocity blood flow through the peri-device gap, resulting in peri-device leak (PDL). Residual leaks are frequently diagnosed after LAA closure procedures, regardless of closure methods. There is a controversy in the clinical significance of the leaks, particularly about its association with thromboembolic events. PDL

Background Readmission after ST‐segment–elevation myocardial infarction ( STEMI ) poses an enormous economic burden to the US healthcare system. There are limited data on the association between length of hospital stay ( LOS ), readmission rate, and overall costs in patients who underwent primary percutaneous coronary intervention for STEMI . Methods and Results All STEMI hospitalizations were selected in the Nationwide Readmissions Database from 2010 to 2014. From the patients who underwent primary percutaneous coronary intervention, we examined the 30‐day outcomes including readmission, mortality, reinfarction, repeat revascularization, and hospital charges/costs according to LOS (1–2, 3, 4, 5, and >5 days) stratified by infarct locations. The 30‐day readmission rate after percutaneous coronary intervention for STEMI was 12.0% in the anterior wall ( AW ) STEMI group and 9.9% in the non‐ AW STEMI group. Patients with a very short LOS (1–2 days) were readmitted less frequently than those with a longer LOS regardless of infarct locations. However, patients with a very short LOS had significantly increased 30‐day readmission mortality versus an LOS of 3 days (hazard ratio, 1.91; CI, 1.16–3.16 [ P =0.01]) only in the AW STEMI group. Total costs (index admission+readmission) were the lowest in the very short LOS cohort in both the AW STEMI group ( P STEMI group ( P Conclusions For patients who underwent primary percutaneous coronary intervention for STEMI , a very short LOS was associated with significantly lower 30‐day readmission and lower cumulative cost. However, a very short LOS was associated with higher 30‐day mortality compared with at least a 3‐day stay in the AW STEMI cohort.

AIMS Bleeding is a major safety outcome in cardiovascular trials. The present study assessed the impact of the adjudication process of bleeding events on three-year outcomes in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial. METHODS AND RESULTS HORIZONS-AMI enrolled 3,602 patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. An independent CEC reviewed 445 potential bleeding events identified from three sources: 339 site-reported (SR), 35 CEC-identified, and 71 database (DB)-triggered events based on programmatic identification of a decline in haemoglobin of ≥3 g/dL or in haematocrit by ≥9%; of those, 383/445 (86.1%) met the protocol definition of major bleeding. By multivariable analysis, CEC-confirmed bleeding was an independent predictor of cardiovascular death (hazard ratio [HR] 2.84, 95% confidence interval [CI]: 1.81-4.45, p

Background Multiple studies have reported a decline in mortality for patients with cardiogenic shock after acute myocardial infarction (CS-AMI), a finding which has been attributed to an increase in revascularization over the past decade. However, other studies that have focused on CS-AMI patients treated with early percutaneous coronary intervention (PCI) have found no improvement in risk-adjusted mortality. To reconcile these discordances, we hypothesize that the clinical complexity of the PCI-population has changed over time, in ways not precisely adjusted for in previous studies. Methods We conducted a retrospective analysis of the 2005–2012 Nationwide Inpatient Sample. Patients with CS-AMI who underwent PCI within 24h of hospitalization were identified. Temporal trends in clinical characteristics and in-hospital mortality were analyzed. Results There was no significant change in un-adjusted in-hospital mortality (30% in 2005–2006 and 27.8% in 2011–2012, OR: 0.90; 95% CI: 0.79–1.01, p=0.07). There was an increase in the proportion of patients with ≥3 Elixhauser comorbidities and comorbidity scores ≥5. The population of patients that suffered from cardiac arrest or needed intubation on the first hospital day increased from 27.8% to 42.6% (p trend Conclusions During a period that corresponds to expanded PCI use and improved prehospital survival, risk-adjusted mortality declined. Much of the survival benefit attributable to early revascularization has been neutralized by an increase in prevalence of "extreme-risk" patients. This may contribute to the null effect on in-hospital mortality.

Patients with cirrhosis often have concomitant coronary artery disease and require percutaneous coronary intervention (PCI). PCI in cirrhotics can be associated with significant risks due to thrombocytopenia, possible coagulopathies, bleeding, and renal failure. Longer term risks of PCI in cirrhotics have not been well studied. Our study seeks to evaluate the 90-day outcomes of PCI in patients with cirrhosis. Patients receiving PCI were identified from the Nationwide Readmissions Database from 2010 to 2014 and stratified by the presence of co-morbid cirrhosis. The total mortality during index admission and 90-day readmissions as well as the readmissions rate were examined. Adverse events including bleeding, stroke, kidney injury, and vascular complications were also compared. Patients with cirrhosis had a significantly higher number of co-morbidities. The cirrhosis group had a higher overall 90-day mortality (10.3% vs 2.5%, p < 0.01), including during the index hospitalization (7.0% vs 1.8%, p < 0.01), as well as a higher 90-day readmission rate (38.2% vs 20.2%, p < 0.01). Patients with cirrhosis also had higher frequencies of overall 90-day adverse events (44.7% vs 17.7%, p < 0.01), including gastrointestinal bleeding (15.3% vs 2.7%, p < 0.01) and acute kidney injury (28.4% vs 10.1%, p < 0.01). In conclusion, patients with cirrhosis face a significantly higher risk of adverse outcomes including mortality, readmissions, and adverse events in the 90 days after hospitalization for PCI compared with the general population.

Background: By virtue of its proximity to structures vital to cardiac conduction, aortomitral continuity calcification (AMCC) may help identify patients at highest risk for developing atrioventricular conduction disease requiring permanent pacemaker implantation (PPMI). We aim to determine the association of AMCC and need for PPMI after transcatheter aortic valve replacement. Methods: Of 614 patients who underwent transcatheter aortic valve replacement (11.8% PPMI rate), we included 136 patients (age 85±8 years, 47% male) without a preexisting intracardiac device or prior valve surgery who underwent preprocedural computed tomography. We analyzed for the presence of AMCC, aortic valve calcification, and mitral annular calcification as well as quantified AMCC and aortic valve calcification score using the Agatston method. We further stratified AMCC score into 3 categories: 0, 1 to 300, and >300. End point was PPMI at 1 month after transcatheter aortic valve replacement. Results: There were 51 (38%) new PPMIs (median time to PPMI, 5 days). Patients who underwent PPMI had a higher prevalence of AMCC than patients without PPMI (69% versus 32%; P P P ≥0.09). Patients with AMCC had a 4-fold increase in odds for PPMI compared with those without (adjusted odds ratio, 4.0; P =0.0026). Compared with patients with an AMCC score of 0, patients with an AMCC score >300 had greater than a 5-fold increased odds for PPMI (adjusted odds ratio, 5.7; P =0.0016). Conclusions: Presence of AMCC, particularly with AMCC score >300, is associated with the need for PPMI after transcatheter aortic valve replacement.

Background Existing data on predictors of late mortality and prevention of sudden cardiac death after atrial switch repair surgery for D‐transposition of the great arteries (D‐ TGA ) are heterogeneous and limited by statistical power. Methods and Results We conducted a systematic review and meta‐analysis of 29 observational studies, comprising 5035 patients, that reported mortality after atrial switch repair with a minimum follow‐up of 10 years. We also examined 4 additional studies comprising 105 patients who reported rates of implantable cardioverter‐defibrillator therapy in this population. Average survival dropped to 65% at 40 years after atrial switch repair , with sudden cardiac death accounting for 45% of all reported deaths. Mortality was significantly lower in cohorts that were more recent and operated on younger patients. Patient‐level risk factors for late mortality were history of supraventricular tachycardia ( odds ratio [OR] 3.8, 95% CI 1.4–10.7), Mustard procedure compared with Senning ( OR 2.9, 95% CI 1.9–4.5) and complex D‐ TGA compared with simple D‐ TGA ( OR 4.4, 95% CI 2.2–8.8). Significant risk factors for sudden cardiac death were history of supraventricular tachycardia ( OR 4.7, 95% CI 2.2–9.8), Mustard procedure ( OR 2.2, 95% CI 1.1–4.1), and complex D‐ TGA ( OR 5.7, 95% CI 1.8–18.0). Out of a total 124 implantable cardioverter‐defibrillator discharges over 330 patient‐years in patients with implantable cardioverter‐defibrillator s for primary prevention, only 8% were appropriate. Conclusions Patient‐level risk of both mortality and sudden cardiac death after atrial switch repair are significantly increased by history of supraventricular tachycardia , Mustard procedure, and complex D‐ TGA . This knowledge may help refine current selection practices for primary prevention implantable cardioverter‐defibrillator implantation, given disproportionately high rates of inappropriate discharges.

Objectives The aim of this study was to report the 1-year results of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. Background Favorable 30-day outcomes of S3 TAVR in annuli >683 mm2 have previously been reported. Pacemaker implantation rates were acceptable, and a larger left ventricular outflow tract and more eccentric annular anatomy were associated with increasing paravalvular leak. Methods From December 2013 to December 2018, 105 patients across 15 centers with mean area 721.3 ± 36.1 mm2 (range: 683.5 to 852.0 mm2) underwent TAVR using an S3 device. Clinical, anatomic, and procedural characteristics were analyzed. One-year survival and echocardiographic follow-up were reached in 94.3% and 82.1% of patients, respectively. Valve Academic Research Consortium-2 30-day and 1-year outcomes were reported. Results The mean age was 76.9 ± 10.4 years, and Society of Thoracic Surgeons predicted risk score averaged 5.2 ± 3.4%. One-year overall mortality and stroke rates were 18.2% and 2.4%, respectively. Quality-of-life index improved from baseline to 30 days and at 1 year (p Conclusions S3 TAVR in annular areas >683 mm2 is feasible, with favorable mid-term outcomes.

Background The ability to accurately predict the occurrence of in‐hospital death after percutaneous coronary intervention is important for clinical decision‐making. We sought to utilize the New York Percutaneous Coronary Intervention Reporting System in order to elucidate the determinants of in‐hospital mortality in patients undergoing percutaneous coronary intervention across New York State. Methods and Results We examined 479 804 patients undergoing percutaneous coronary intervention between 2004 and 2012, utilizing traditional and advanced machine learning algorithms to determine the most significant predictors of in‐hospital mortality. The entire data were randomly split into a training (80%) and a testing set (20%). Tuned hyperparameters were used to generate a trained model while the performance of the model was independently evaluated on the testing set after plotting a receiver‐operator characteristic curve and using the output measure of the area under the curve ( AUC ) and the associated 95% CIs. Mean age was 65.2±11.9 years and 68.5% were women. There were 2549 in‐hospital deaths within the patient population. A boosted ensemble algorithm (AdaBoost) had optimal discrimination with AUC of 0.927 (95% CI 0.923–0.929) compared with AUC of 0.913 for XGB oost (95% CI 0.906–0.919, P =0.02), AUC of 0.892 for Random Forest (95% CI 0.889–0.896, P AUC of 0.908 for logistic regression (95% CI 0.907–0.910, P Conclusions A big data approach that utilizes advanced machine learning algorithms identifies new associations among risk factors and provides high accuracy for the prediction of in‐hospital mortality in patients undergoing percutaneous coronary intervention.

The primary mode of visualization during transcatheter procedures for structrural heart disease is fluoroscopy, which suffers from low contrast and lacks any depth perception, thus limiting the ability of an interventionalist to position a catheter accurately. This paper describes a new image guidance system by utilizing augmented reality to provide a 3D visual environment and quantitative feedback of the catheter's position within the heart of the patient. The real-time 3D position of the catheter is acquired via two fluoroscopic images taken at different angles, and a patient-specific 3D heart rendering is produced pre-operatively from a CT scan. The spine acts as a fiduciary land marker, allowing the position and orientation of the catheter within the heart to be fully registered. The automated registration method is based on Fourier transformation, and has a high success rate (100%), low registration error (0.42 mm), and clinically acceptable computational cost (1.22 second). The 3D renderings are displayed and updated on the augmented reality device (i.e., Microsoft HoloLens), which can provide pre-set views of various angles of the heart using voice-command. This new image-guidance system with augmented reality provides a better visualization to interventionalists and potentially assists them in understanding of complicated cases. Furthermore, this system coupled with the developed 3D printed models can serve as a training tool for the next generation of cardiac interventionalists.

Aims We sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)]. Methods and results From the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0 ± 7.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; P

MitraClip therapy has shown increasing use since it was commercially adopted among US hospitals in October 2013. However, the relation of institutional MitraClip volume with outcomes is unclear. This study sought to examine the association between hospital volume and outcomes after transcatheter mitral valve repair using the MitraClip device. Using the Nationwide Readmissions Database, we identified all patients who underwent a MitraClip procedure and categorized hospitals into tertiles based on their annual procedure volume: low (≤3 procedures/year), medium (4 to 13/year), and high (≥14/year) volume centers. Multivariable logistic and Cox regression analyses were performed to examine the impact of institutional MitraClip volume on in-hospital and 90-day outcomes, respectively. From 2014 to 2015, a total of 3,420 procedures were performed at 266 hospitals with a median annual procedural volume of 5 per hospital. Low (n = 81), medium (n = 86), and high (n = 99) volume hospitals performed 147 (4.3%), 403 (11.8%), and 2,870 (83.9%) MitraClip procedures, respectively. The low versus high hospital volume was independently associated with increased in-hospital mortality (7.8% vs 3.0%; adjusted odds ratio [aOR] 2.64; p = 0.04), acute myocardial infarction (10.2% vs 2.2%; aOR 2.93; p = 0.02), and acute respiratory failure (19.3% vs 7.7%; aOR 2.24; p = 0.02) during index admission as well as 90-day all-cause readmissions (37.8% vs 26.6%; adjusted hazard ratio 1.54; p = 0.03), and 90-day infective endocarditis (2.4% vs 0.3%; adjusted hazard ratio 10.06; p = 0.003). In conclusion, low hospital MitraClip volume is an independent determinant of worse outcomes including in-hospital mortality and 90-day readmissions.

Background: Near-infrared spectroscopy (NIRS) intravascular ultrasound imaging can detect lipid-rich plaques (LRPs). LRPs are associated with acute coronary syndromes or myocardial infarction, which can result in revascularisation or cardiac death. In this study, we aimed to establish the relationship between LRPs detected by NIRS-intravascular ultrasound imaging at unstented sites and subsequent coronary events from new culprit lesions. Methods: In this prospective, cohort study (LRP), patients from 44 medical centres were enrolled in Italy, Latvia, Netherlands, Slovakia, UK, and the USA. Patients with suspected coronary artery disease who underwent cardiac catheterisation with possible ad hoc percutaneous coronary intervention were eligible to be enrolled. Enrolled patients underwent scanning of non-culprit segments using NIRS-intravascular ultrasound imaging. The study had two hierarchal primary hypotheses, patient and plaque, each testing the association between maximum 4 mm Lipid Core Burden Index (maxLCBI4mm) and non-culprit major adverse cardiovascular events (NC-MACE). Enrolled patients with large LRPs (≥250 maxLCBI4mm) and a randomly selected half of patients with small LRPs (

Background Readmission after ST‐segment–elevation myocardial infarction ( STEMI ) poses an enormous economic burden to the US healthcare system. Efforts to prevent readmissions should be based on understanding the timing and causes of these readmissions. This study aimed to investigate contemporary causes, timing, and cost of 30‐day readmissions after STEMI . Methods and Results All STEMI hospitalizations were selected in the Nationwide Readmissions Database ( NRD ) from 2010 to 2014. The 30‐day readmission rate as well as the primary cause and cost of readmission were examined. Multivariate regression analysis was performed to identify the predictors of 30‐day readmission and increased cumulative cost. From 2010 to 2014, the 30‐day readmission rate after STEMI was 12.3%. Within 7 days of discharge, 43.9% were readmitted, and 67.3% were readmitted within 14 days. The annual rate of 30‐day readmission decreased by 19% from 2010 to 2014 ( P AIDS , anemia, chronic kidney disease , collagen vascular disease, diabetes mellitus, hypertension, pulmonary hypertension, congestive heart failure , atrial fibrillation, and increased length of stay were independent predictors of 30‐day readmission. A large proportion of patients (41.6%) were readmitted for noncardiac reasons. After multivariate adjustment, 30‐day readmission was associated with a 47.9% increase in cumulative cost ( P Conclusions Two thirds of patients were readmitted within the first 14 days after STEMI , and a large proportion of patients were readmitted for noncardiac reasons. Thirty‐day readmission was associated with an ≈50% increase in cumulative hospitalization costs. These findings highlight the importance of closer surveillance of both cardiac and general medical conditions in the first several weeks after STEMI discharge.

Objectives Left atrial appendage thrombus (LAT) was an exclusion criterion in the seminal transcatheter aortic valve replacement (TAVR) trials; however, such patients do undergo TAVR in the 'real-world' setting. This study sought to analyse outcomes after TAVR in patients with LAT or spontaneous echo contrast (SEC). Methods All patients undergoing TAVR at our institution between March 2009 and December 2014 were prospectively analysed. The presence of LAT or SEC was determined via a retrospective chart review. Primary outcomes included 30-day and 1-year neurological events as well as mortality. Results Of the 369 patients undergoing TAVR, 3.8% (14) were found to have LAT and 6.8% (25) were found to have SEC, and they were separately compared to patients who did not have LAT or SEC. Significant differences were noted between groups with regard to preoperative renal function, atrial fibrillation and ejection fraction. Preoperative atrial fibrillation was the only independent predictor of LAT. No perioperative complications were associated with the presence of LAT or SEC. Specifically, no patient with LAT or SEC experienced a postoperative neurological event. While neither LAT nor SEC was an independent predictor of 30-day mortality, LAT was an independent predictor of 1-year mortality (odds ratio 3.573, 95% confidence interval 1.040-12.28; P = 0.042). Conclusions The current study suggests that TAVR may be performed in patients with LAT and SEC with a low risk of embolic complications. While neither was an independent predictor of 30-day mortality, LAT was an independent predictor of 1-year mortality. Larger studies are needed to better study this phenomenon.

With the expected growth in the elderly segment of the U.S. population particularly in women, the prevalence of valvular heart disease is bound to increase in the coming years. We sought to delineate the impact of gender on in-hospital clinical outcomes in Medicare-age patients undergoing isolated left-side heart valve surgery.Using the National Inpatient Sample files from 2003 to 2014, we compared the in-hospital major adverse cardiac and cerebral events (MACCE: all-cause mortality, stroke, or myocardial infarction) and composite complications (MACCE, permanent pacemaker implantation, bleeding requiring transfusion, iatrogenic vascular complications, acute respiratory failure, acute kidney injury requiring hemodialysis, sepsis and prolonged hospital stay) following isolated mitral or aortic surgery between genders with 1:1 propensity score analysis. Further, we examined gender-specific temporal trends of in-hospital clinical outcomes over the study period.There were 336,506 isolated left-side heart valve surgeries over the study period. Following propensity score matching, 24,637 unweighted pairs were identified for gender-specific comparison. Female gender was independently associated with a higher in-hospital MACCE (9.4% vs. 8.3%; OR = 1.14, 95% CI = 1.07-1.21, P 0.0001) driven mostly by all-cause mortality (5.2% vs. 4.3%; OR = 1.33, 95% CI = 1.12-1.33, P 0.0001). The composite complication rate (37.9% vs. 35.3%; OR = 1.12, 95% CI-1.08-1.16, P 0.0001) was also higher in women. Significant reduction in both in-hospital MACCE and all-cause mortality was observed over time regardless of gender.Following isolated left-side heart valve surgery, women experienced higher in-hospital MACCE including all-cause mortality compared to men. Continued temporal improvements in in-hospital clinical outcomes were observed in both genders.The influence of gender on surgical aortic or mitral valve replacement/repair outcome is unclear. The current study showed that women fared worse than men including all-cause mortality following isolated left-side valve surgery and significant temporal improvements have been made in in-hospital clinical outcomes in both genders during the 12-year study period. Further research in gender-specific approach in management of valve disease is warranted.

Objectives The aim of this study was to determine factors affecting paravalvular leak (PVL) in transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. Background The largest recommended annular area for the 29-mm S3 is 683 mm2. However, experience with S3 TAVR in annuli >683 mm2 has not been widely reported. Methods From December 2013 to July 2017, 74 patients across 16 centers with mean area 721 ± 38 mm2 (range: 684 to 852 mm2) underwent S3 TAVR. The transfemoral approach was used in 95%, and 39% were under conscious sedation. Patient, anatomic, and procedural characteristics were retrospectively analyzed. Valve Academic Research Consortium–2 outcomes were reported. Results Procedural success was 100%, with 2 deaths, 1 stroke, and 2 major vascular complications at 30 days. Post-dilatation occurred in 32%, with final balloon overfilling (1 to 5 ml extra) in 70% of patients. Implantation depth averaged 22.3 ± 12.4% at the noncoronary cusp and 20.7 ± 9.9% at the left coronary cusp. New left bundle branch block occurred in 17%, and 6.3% required new permanent pacemakers. Thirty-day echocardiography showed mild PVL in 22.3%, 6.9% moderate, and none severe. There was no annular rupture or coronary obstruction. Mild or greater PVL was associated with larger maximum annular and left ventricular outflow tract (LVOT) diameters, larger LVOT area and perimeter, LVOT area greater than annular area, and higher annular eccentricity. Conclusions TAVR with the 29-mm S3 valve beyond the recommended range by overexpansion is safe, with acceptable PVL and pacemaker rates. Larger LVOTs and more eccentric annuli were associated with more PVL. Longer term follow-up will be needed to determine durability of S3 TAVR in this population.

With the rapid advance of transcatheter aortic valve implantation (TAVI), it is important to evaluate the relationship between TAVI volumes and outcomes. The aim of this study was to analyze in-hospital outcomes after TAVI stratified according to hospital volumes. Using the National Inpatient Sample files from 2012, hospitals performing transfemoral (TF)-TAVI and transapical (TA)-TAVI were divided into high-volume and low-volume centers. A total of 7,660 patients underwent TAVI in 256 hospitals in 2012. In the TF-TAVI cohort, multivariate logistic regression analyses demonstrated that low TF-TAVI volume status was an independent predictor of death and bleeding. In the TA-TAVI cohort, low volume status was a predictor of death, myocardial infarction, and need for permanent pacemaker. In addition, hospitals that performed low TA-TAVI volume were associated with significantly higher rate of death after surgical aortic valve replacement in comparison with the hospitals that perform high TA-TAVI volume (3.6% vs 2.3%, p

Objectives: The role of aortic angulation in attenuating procedural success in balloon-expandable (BE) and self-expandable (SE) transcatheter aortic valve replacement (TAVR) has been controversial. Methods: We retrospectively assessed patients undergoing SE and BE TAVR who had an aortic angle measured on multidetector computed tomography at a single tertiary referral center. The primary outcome was device success, measured per the Valve Academic Research Consortium-2 criteria. Clinical outcomes at 30 days (including mortality) were also assessed. Results: A total of 251 patients were identified; 182 patients received a BE valve and 69 patients an SE valve. The median aortic angle was 46.8° (range 24.4–70°) in the BE group and 43.3° (range 20–71°) in the SE group. In multivariate logistic regression analysis, aortic angulation did not affect device success. Mortality at 30 days and 12 months and postprocedural clinical outcomes were similarly not associated with aortic angulation. Conclusion: In this cohort of patients undergoing BE and SE TAVR over a wide range of aortic angles, we found no associations between angle and device success or any other clinical metrics. Increased aortic angulation does not adversely affect outcomes in BE or SE TAVR.

Background Limited data exist regarding transcatheter mitral valve replacement (TMVR) for patients with failed mitral valve replacement and repair. Objectives This study sought to evaluate the outcomes of TMVR in patients with failed mitral bioprosthetic valves (valve-in-valve [ViV]) and annuloplasty rings (valve-in-ring [ViR]). Methods From the TMVR multicenter registry, procedural and clinical outcomes of mitral ViV and ViR were compared according to Mitral Valve Academic Research Consortium criteria. Results A total of 248 patients with mean Society of Thoracic Surgeons score of 8.9 ± 6.8% underwent TMVR. Transseptal access and the balloon-expandable valve were used in 33.1% and 89.9%, respectively. Compared with 176 patients undergoing ViV, 72 patients undergoing ViR had lower left ventricular ejection fraction (45.6 ± 17.4% vs. 55.3 ± 11.1%; p < 0.001). Overall technical and device success rates were acceptable, at 92.3% and 85.5%, respectively. However, compared with the ViV group, the ViR group had lower technical success (83.3% vs. 96.0%; p = 0.001) due to more frequent second valve implantation (11.1% vs. 2.8%; p = 0.008), and lower device success (76.4% vs. 89.2%; p = 0.009) due to more frequent reintervention (16.7% vs. 7.4%; p = 0.03). Mean mitral valve gradients were similar between groups (6.4 ± 2.3 mm Hg vs. 5.8 ± 2.7 mm Hg; p = 0.17), whereas the ViR group had more frequent post-procedural mitral regurgitation moderate or higher (19.4% vs. 6.8%; p = 0.003). Furthermore, the ViR group had more frequent life-threatening bleeding (8.3% vs. 2.3%; p = 0.03), acute kidney injury (11.1% vs. 4.0%; p = 0.03), and subsequent lower procedural success (58.3% vs. 79.5%; p = 0.001). The 1-year all-cause mortality rate was significantly higher in the ViR group compared with the ViV group (28.7% vs. 12.6%; log-rank test, p = 0.01). On multivariable analysis, failed annuloplasty ring was independently associated with all-cause mortality (hazard ratio: 2.70; 95% confidence interval: 1.34 to 5.43; p = 0.005). Conclusions The TMVR procedure provided acceptable outcomes in high-risk patients with degenerated bioprostheses or failed annuloplasty rings, but mitral ViR was associated with higher rates of procedural complications and mid-term mortality compared with mitral ViV.

Clinical pathways can optimize care both across and within institutions, but regular updates to these pathways based on new clinical trials, professional guidelines, and Food and Drug Administration approvals are essential. Herein we describe the most recent revisions to the New York- Presbyterian Hospital (Columbia University Medical Center and Weill Cornell Medical Center) clinical pathway for acute coronary syndromes and chest pain, which incorporates novel data regarding the timing and administration of P2Y12 inhibition (including the intravenous P2Y12 inhibitor cangrelor) and the appropriateness of prolonged (>1 year) dual antiplatelet therapy for the secondary prevention of ischemic events.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is being increasingly performed in patients with bicuspid aortic valve stenosis (AS).OBJECTIVES: This study sought to compare the procedural and clinical outcomes in patients with bicuspid versus tricuspid AS from the Bicuspid AS TAVR multicenter registry.METHODS: Outcomes of 561 patients with bicuspid AS and 4,546 patients with tricuspid AS were compared after propensity score matching, assembling 546 pairs of patients with similar baseline characteristics. Procedural and clinical outcomes were recorded according to Valve Academic Research Consortium-2 criteria.RESULTS: Compared with patients with tricuspid AS, patients with bicuspid AS had more frequent conversion to surgery (2.0% vs. 0.2%; p = 0.006) and a significantly lower device success rate (85.3% vs. 91.4%; p = 0.002). Early-generation devices were implanted in 320 patients with bicuspid and 321 patients with tricuspid AS, whereas new-generation devices were implanted in 226 and 225 patients with bicuspid and tricuspid AS, respectively. Within the group receiving early-generation devices, bicuspid AS had more frequent aortic root injury (4.5% vs. 0.0%; p = 0.015) when receiving the balloon-expanding device, and moderate-to-severe paravalvular leak (19.4% vs. 10.5%; p = 0.02) when receiving the self-expanding device. Among patients with new-generation devices, however, procedural results were comparable across different prostheses. The cumulative all-cause mortality rates at 2 years were comparable between bicuspid and tricuspid AS (17.2% vs. 19.4%; p = 0.28).CONCLUSIONS: Compared with tricuspid AS, TAVR in bicuspid AS was associated with a similar prognosis, but lower device success rate. Procedural differences were observed in patients treated with the early-generation devices, whereas no differences were observed with the new-generation devices.

Background— Given the controversy regarding whether carotid endarterectomy (CEA) or carotid artery stenting (CAS) may be superior for stroke prevention, it is uncertain how recent clinical evidence, guidelines, and reimbursement policies have influenced the volume and outcomes after these procedures. Methods and Results— We conducted a serial, cross-sectional study with time trends of patients undergoing CAS (n=124 265) and CEA (n=1 260 647) between 2001 and 2010 from the Nationwide Inpatient Sample database. During the 10-year period, the frequency of CEA declined, whereas CAS use slowly increased. After multivariate propensity score–matched analysis, CAS was associated with an increased risk of death (odds ratio [OR], 1.69; 95% confidence interval [CI], 1.40–2.04), stroke (OR, 1.43; 95% CI, 1.23–1.66), and major adverse events including death, stroke, and myocardial infarction (OR, 1.25; 95% CI, 1.13–1.39). In asymptomatic patients, there was no significant difference in major adverse events (OR, 1.08; 95% CI, 0.92–1.20; P =0.16 [ P P for trend=0.03] and major adverse events [OR, 0.75; 95% CI, 0.66–0.84; P for trend=0.05] comparing years 2010 versus 2001). Conclusions— In US hospitals between 2001 and 2010, CAS was associated with worse in-hospital outcomes, partly attributable to selection and ascertainment bias. Asymptomatic patients undergoing CAS versus CEA had similar adjusted rates of major adverse events. CAS outcomes improved significantly during the course of the decade likely attributable to improvements in patient selection, operator skills, and technological advancements.

Although the benefit of percutaneous coronary interventions (PCIs) for patients presenting with acute coronary syndromes (ACS) has been established in numerous studies, the role of PCI in stable coronary artery disease (CAD) remains controversial. With the publication of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluations trial and the appropriate use criteria for coronary artery revascularization, we sought to examine the impact of these treatment strategies and guidelines on the current practice of PCI in United States. We conducted a serial cross-sectional study with time trends of patients undergoing PCI for ACS and stable CAD from 2007 to 2011. The annual rate of all PCI decreased by 27.7% from 10,785 procedures per million adults per year in 2007 to 2008 to 7,801 procedures per million adults per year in 2010 to 2011 (p = 0.03). Although there was no statistically significant decrease in the PCI utilization for ACS from 2007 to 2011, PCI utilization for stable CAD decreased by 51.7% (from 2,056 procedures per million adults per year in 2008 to 992 procedures per million adults per year in 2011, p = 0.02). Hospitals with a higher volume of PCI experienced a more significant decrease. Decrease in PCI utilization for stable CAD was statistically significant for patients with Medicare and private insurance/health maintenance organization (44.5%, p = 0.03 and 59.5%, p = 0.007, respectively). In conclusion, the rate of PCI decreased substantially starting from 2009 in the United States. Most of the decrease was attributed to the reduction in PCI utilization for stable CAD.

Perspective: Radial Access Is Preferred Dr. Rao is a consultant for and has received honoraria from Terumo Medical and The Medicines Company. In the world of cardiovascular medicine, debates are as common as unanswered questions—medical therapy versus percutaneous coronary intervention (PCI

Paravalvular aortic regurgitation (PAR) remains a common complication following transcatheter aortic valve replacement (TAVR), and has been associated with increased mortality. Adverse left ventricular (LV) remodelling has been reported in patients with post-TAVR PAR, but the association between adverse LV remodeling and increased mortality remains unclear. The aim of the present study was to examine the association between PAR, LV remodeling and mortality following TAVR in a non-PARTNER (Placement of Aortic Transcatheter Valves) trial population.A total of 195 patients that underwent TAVR was included in the study. The LV ejection fraction (LVEF), LV mass index (LVMI), LV internal dimension at systole (LVIDs) and diastole (LVIDd) were compared between patients with different degrees of PAR at baseline, and at one month and one year after TAVR. Survival analysis was performed for different degrees of PAR and LV remodeling.PAR ≥moderate was associated with increased mortality (HR 4.58 [1.80-11.63], p = 0.001), but PARmild was not. The LVIDd and LVIDs were persistently increased at one year after TAVR in patients with PARmild compared to those with PAR ≤mild (5.9 ± 0.8 cm versus 5.4 ± 0.7 cm, p = 0.02 and 4.4 ± 0.8 cm versus 3.9 ± 0.8, p = 0.03, respectively). The LVEF was improved similarly between the two groups at one year after TAVR (p = 0.1). Patients with PAR ≥moderate had significantly more adverse LV remodeling at one month after TAVR in terms of LVIDd, LVIDs, and LVMI. The degree of remodeling as expressed in terms of LVIDd, LVIDs, LVMI and LVEF changes from baseline did not have a direct impact on mortality.A worse PAR was associated with more adverse LV remodeling and a higher mortality after TAVR in a non-PARTNER patient population.

Percutaneous repair of the mitral valve has been widely adopted for the treatment of primary, symptomatic severe mitral regurgitation in patients at prohibitive risk for surgical intervention. We present a case of an elderly female patient with moderate-to-severe mitral regurgitation who underwent MitraClip procedure, with postprocedural course remarkable for the development of right-to-left shunting and hypoxia, for which the patient underwent a percutaneous repair of the atrial septal defect with immediate recovery of oxygen saturation.

Registry-driven data have shown a significant decrease in door-to-balloon (DTB) times in patients with ST-elevation myocardial infarction (STEMI) receiving percutaneous coronary intervention (PCI). We sought to determine the trends in reperfusion times (symptom-onset to door (SOTD) and DTB times) in patients presenting with STEMI across New York State.We retrospectively examined 35,613 STEMI patients receiving PCI from 2004 to 2012 and compared median SOTD and DTB times across years. Patients with SOTD time12h and DTB time3h were excluded.There was a statistically significant trend towards shorter DTB times (median DTB time of 83min (IQR 53, 116) in 2004 to a median DTB time of 59min (IQR 40, 78) in 2012, P0.01 for trend) and SOTD times (median SOTD time of 127min (IQR 64, 241) in 2004 to a median SOTD time of 116min (IQR 60, 205) in 2012, P0.01 for trend). In subgroup analysis, demographics and the presence of co-morbid conditions did not influence the trend in reperfusion times. However, women had longer reperfusion times than men in 2012. After adjusting for confounding variables, DTB was a significant predictor of in-hospital mortality (HR=1.04 (per 10minutes), P0.01).There was a significant decrease in reperfusion times from 2004 to 2012 in STEMI patients across New York State. This trend was significant regardless of the presence of co-morbid conditions, although a significant gap in reperfusion times persists between men and women.

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.Inconsistent safety profiles, costs and learning curves of earlier generation vascular closure devices have limited their widespread use following transfemoral procedures.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.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.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.

Previous data on septal myectomy (SM) and alcohol septal ablation (ASA) in obstructive hypertrophic cardiomyopathy have been limited to small, nonrandomized, single-center studies. Use of septal reduction therapy and the effect of institutional experience on procedural outcomes nationally are unknown.To examine in-hospital outcomes after SM and ASA stratified by hospital volume within a large, national inpatient database.This study analyzed all patients who were hospitalized for SM or ASA in a nationwide inpatient database from January 1, 2003, through December 31, 2011.Rates of adverse in-hospital events (death, stroke, bleeding, acute renal failure, and need for permanent pacemaker) were examined. Multivariate logistic regression analysis was performed to compare overall outcomes after each procedure based on tertiles of hospital volume of SM and ASA.Of 71 888 761 discharge records reviewed, a total of 11 248 patients underwent septal reduction procedures, of whom 6386 (56.8%) underwent SM and 4862 (43.2%) underwent ASA. A total of 59.9% of institutions performed 10 SM procedures or fewer, whereas 66.9% of institutions performed 10 ASA procedures or fewer during the study period. Incidence of in-hospital death (15.6%, 9.6%, and 3.8%; P .001), need for permanent pacemaker (10.0%, 13.8%, and 8.9%; P .001), and bleeding complications (3.3%, 3.8%, and 1.7%; P .001) after SM was lower in higher-volume centers when stratified by first, second, and third tertiles of hospital volume, respectively. Similarly, there was a lower incidence of death (2.3%, 0.8%, and 0.6%; P = .02) and acute renal failure (6.2%, 7.6%, and 2.4%; P .001) after ASA in higher-volume centers. The lowest tertile of SM volume among hospitals was an independent predictor of in-hospital all-cause mortality (adjusted odds ratio, 3.11; 95% CI, 1.98-4.89) and bleeding (adjusted odds ratio, 3.77; 95% CI, 2.12-6.70), whereas being in the lowest tertile of ASA by volume was not independently associated with an increased risk of adverse postprocedural events.In US hospitals from 2003 through 2011, most centers that provide septal reduction therapy performed few SM and ASA procedures, which is below the threshold recommended by the 2011 American College of Cardiology Foundation/American Heart Association Task Force Guideline for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy. Low SM volume was associated with worse outcomes, including higher mortality, longer length of stay, and higher costs. More efforts are needed to encourage referral of patients to centers of excellence for septal reduction therapy.

To examine peri-procedural and long-term outcomes in patients with chronic kidney disease (CKD) undergoing percutaneous coronary interventions (PCI).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.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.Patients were grouped by CKD stages: 1,351 patients with eGFR ≥90 mL/min/1.73 mAmong patients undergoing PCI, lower GFR is associated with decreased long-term survival. © 2016 Wiley Periodicals, Inc.

Background Recent studies have shown improving survival after cardiac arrest. However, data regarding sex‐based disparities in treatment and outcomes after cardiac arrest are limited. Methods and Results We performed a retrospective analysis of all patients suffering cardiac arrest between 2003 and 2012 using the Nationwide Inpatient Sample database. Annual rates of cardiac arrest, rates of utilization of coronary angiography/percutaneous coronary interventions/targeted temperature management, and sex‐based outcomes after cardiac arrest were examined. Among a total of 1 436 052 discharge records analyzed for cardiac arrest patients, 45.4% (n=651 745) were females. Women were less likely to present with ventricular tachycardia/ventricular fibrillation arrests compared with men throughout the study period. The annual rates of cardiac arrests have increased from 2003 to 2012 by 14.0% ( P trend P trend P trend P trend P P Conclusions Women presenting with cardiac arrests are less likely to undergo therapeutic procedures, including coronary angiography, percutaneous coronary interventions, and targeted temperature management. Despite trends in improving survival after cardiac arrest over 10 years, women continue to have higher in‐hospital mortality when compared with men.

Multidetector computed tomography (MDCT) is widely used for transcatheter aortic valve replacement (TAVR) planning, and its use predicts and prevents complications. To date, the reproducibility of aortoiliofemoral measurements and prediction of fluoroscopic angles for TAVR deployment remain inadequately studied.Twenty-five consecutive patients (six males, 19 females; mean age 81.1 years) undergoing pre-procedural evaluation for TAVR were studied for 74 separate variables by MDCT. Two experienced readers made repeated measurements of the diameter and area of the aortic annulus, the aortic root at the level of the sinuses of Valsalva, sinotubular junction, and ascending aorta, and the diameters of peripheral vessels at the level of the distal abdominal aorta, and the iliofemoral arteries. A fluoroscopic angle prediction was obtained for left anterior oblique (LAO) 0 degrees, 20 degrees and 30 degrees projections. Pearson's correlation coefficient (r) was obtained, and intra-class correlation coefficients and Bland-Altman plots were generated to examine agreements, respectively.The mean aortic valve area was 0.7 cm2. Each measurement generally showed good intra- and inter-observer reproducibility. The mean difference between readers was -0.3 mm for mean annular diameter and 3.6 mm2 for annular area. The area- derived diameter showed better reproducibility than the mean diameter (ICC 0.87, 0.84). However, the right coronary artery height showed poor inter-observer agreement (ICC 0.48). Angle predictions for 0 degrees, 20 degrees and 30 degrees-LAO were reproducible within and between readers (ICC 0.68-0.96 and 0.75-0.85). Qualitative assessments were also reliable between readers.Inter- and intra-observer measurements of the pre-TAVR planning parameters are reliable, with generally a high degree of agreement.

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).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.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.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.Even mild post-TAVR AI may have a negative impact on outcomes of patients with underlying severe DD. © 2016 Wiley Periodicals, Inc.

Background Hospitalizations for heart failure with preserved ejection fraction (HFpEF) are increasing. There are limited data examining national trends in patients hospitalized with HFpEF. Methods Using the Nationwide Inpatient Sample, we examined 5,046,879 hospitalizations with a diagnosis of acute heart failure in 2003-2012, stratifying hospitalizations by HFpEF and heart failure with reduced ejection fraction (HFrEF). Patient and hospital characteristics, in-hospital mortality, and length of stay were examined. Results Compared with HFrEF, those with HFpEF were older, more commonly female, and more likely to have hypertension, atrial fibrillation, chronic lung disease, chronic renal failure, and anemia. Over time, HFpEF comprised increasing proportions of men and patients aged ≥75 years. In-hospital mortality rate for HFpEF decreased by 13%, largely due to improved survival in those aged ≥65 years. Multivariable regression analyses showed that pulmonary circulation disorders, liver disease, and chronic renal failure were independent predictors of in-hospital mortality, whereas treatable diseases including hypertension, coronary artery disease, and diabetes were inversely associated. Conclusions This study represents the largest cohort of patients hospitalized with HFpEF to date, yielding the following observations: number of hospitalizations for HFpEF was comparable with that of HFrEF; patients with HFpEF were most often women and elderly, with a high burden of comorbidities; outcomes appeared improved among a subset of patients; pulmonary hypertension, liver disease, and chronic renal failure were strongly associated with poor outcomes.

Periprocedural statin therapy has been shown to decrease the rate of myocardial infarctions (MIs) after percutaneous coronary intervention (PCI). However, the impact of long-term statin therapy on postprocedure MI remains unknown. We examined the impact of long-term statin therapy on cardiac enzyme (cardiac troponin I [cTnI] and creatine kinase-MB [CK-MB]) increases after PCI in patients undergoing nonemergency PCI. Using the 2004/2005 Cornell Angioplasty Registry, we evaluated 1,482 patients undergoing elective or urgent PCI with normal preprocedure cardiac enzymes levels (cTnI and CK-MB). The population was divided into 2 groups: (1) patients on long-term (≥7 days) statin therapy before PCI (n = 1,073) and (2) patients not on long-term statin regimen (n = 409). Cardiac enzyme levels after PCI were assessed at 8, 12, and 18 hours after PCI. An increase in cTnI ≥1 time upper-limit of normal (ULN) was observed in 830 patients (56.1%) and an increase in cTnI ≥3 times ULN was observed in 518 patients (35.0%). There was no difference in incidence of cTnI increases ≥3 times ULN in patients on long-term statin therapy versus those not on long-term statin therapy in the overall group (35.1% vs 34.5%, p = 0.855). There was a trend toward a lower incidence of small cTnI increases ≥1 time ULN in patients on long-term statin therapy versus those not receiving long-term statins (54.6% vs 59.7%, p = 0.090). Incidence of CK-MB increases ≥1 time or ≥3 times ULN and peak cTnI and CK-MB levels were similar between the 2 groups. In a subgroup of patients with unstable angina, long-term statin therapy decreased small cTnI increases (≥1 time ULN) after PCI (54.6% vs 64.3%, p = 0.023). The greatest benefit in decrease of MIs after PCI was seen in patients with unstable angina receiving long-term high-dose statin therapy. In conclusion, long-term statin therapy did not decrease the incidence of periprocedural MI in patients with stable coronary artery disease undergoing nonemergency PCI. In patients with unstable coronary syndromes, long-term statin therapy may be beneficial, particularly at a high dose.

ObjectivesThe aim of this study was to describe differences in treatment and in-hospital mortality of early, late, and very late stent thrombosis (ST).BackgroundEarly, late, and very late ST may differ in clinical presentation, management, and in-hospital outcomes.MethodsWe analyzed definite (angiographically documented) ST cases identified from February 2009 to June 2010 in the CathPCI Registry. We stratified events by timing of presentation: early (≤1 month), late (1 to 12 months), or very late (≥12 months) following stent implantation. Multivariable logistic regression modeling was performed to compare in-hospital mortality for each type of ST after adjusting for baseline comorbidities.ResultsDuring the study period, 7,315 ST events were identified in 7,079 of 401,662 patients (1.8%) presenting with acute coronary syndromes. This ST cohort consisted of 1,391 patients with early ST (19.6%), 1,370 with late ST (19.4%), and 4,318 with very late ST (61.0%). Subjects with early ST had a higher prevalence of black race and diabetes, whereas subjects with very late ST had a higher prevalence of white race and a lower prevalence of prior myocardial infarction or diabetes. In-hospital mortality was significantly higher in early ST (7.9%) compared with late (3.8%) and very late ST (3.6%, p < 0.001). This lower mortality for late and very late ST persisted after multivariable adjustment (odds ratio: 0.53 [95% confidence interval (CI): 0.36 to 0.79] and 0.58 [95% CI: 0.43 to 0.79], respectively).ConclusionsSignificant differences exist in the presentation and outcomes of early, late, and very late ST. Among patients with acute coronary syndromes who are undergoing percutaneous coronary intervention for angiographically documented ST, early ST is associated with the highest in-hospital mortality.

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.

Background Despite advances in ST-segment elevation myocardial infarction (STEMI) systems of care over the last decade, studies have shown no improvement in risk-adjusted mortality. It has been hypothesized that the population presenting to the catheterization laboratory has become sicker over time, in ways not accurately captured by current mortality models. The objective of this study was to examine changes in the clinical characteristics and in-hospital case fatality rate of the STEMI population treated with early percutaneous coronary intervention (PCI). Methods We conducted a retrospective analysis of a nationwide inpatient database for the period 2004-2012. All patients with a diagnosis of STEMI who underwent PCI within 24 hours of admission were identified. The primary outcome was in-hospital mortality. Results From 2004 to 2012 there was a consistent increase in unadjusted in-hospital mortality (3.9% in 2004 and 4.7% in 2012, odds ratio year 1.03; 95% confidence interval 1.01-1.04). During this time there was an increase in the proportion of patients with ≥3 Elixhauser comorbidities (14.8% vs 29.0%, P trend P trend year 0.95; 95% confidence interval 0.94-0.97). Conclusions During a period that corresponds to improvement in STEMI quality of care, risk-adjusted in-hospital mortality declined. An increase in comorbidities, and more importantly in the proportion of patients presenting with extreme-risk features, may explain the overall "null" effect regarding in-hospital mortality despite improvements in timely reperfusion.

Increases of creatine kinase (CK) and CK-MB cardiac enzymes after nonemergent percutaneous coronary intervention (PCI) have been associated with an increased risk of cardiovascular events during follow-up. However, there are limited data about the incidence and prognostic significance of an isolated increase of cardiac troponin I (cTnI) without an increase in CK-MB after PCI. The aim of this study was to evaluate the impact of an isolated cTnI increase on long-term survival in patients undergoing nonemergent PCI with normal CK-MB levels after PCI. Using the 2004/2005 Cornell Angioplasty Registry, we evaluated the clinical outcomes in 1,601 patients (undergoing elective or urgent PCI) with normal preprocedure cTnI and CK-MB and normal CK-MB levels after the procedure. Patients were divided into 2 groups based on the presence of cTnI increase after PCI. The mean follow-up period was 24.6 +/- 7.6 months. An increase in cTnI was observed in 831 patients (51.9%). Drug-eluting stents were used in 87% of patients and glycoprotein IIb/IIIa inhibitors were administered in 48% of patients. Incidence of in-hospital major adverse cardiovascular events was low, 0.1% versus 0% (p = 1.000), in patients with versus without cTnI increases, respectively. By 2 years of follow-up, Kaplan-Meier survival rates were 94.1% versus 96.4% (log-rank p = 0.020) in those with versus without cTnI increases, respectively. By multivariate Cox regression analysis, an increase in cTnI after PCI (hazard ratio 1.62, 95% confidence interval 1.01 to 2.59, p = 0.047) was an independent predictor of increased long-term mortality. In conclusion, an isolated increase in cTnI after nonemergent PCI is common, not associated with more frequent adverse in-hospital outcomes compared to patients with normal cTnI, and provides long-term prognostic information regarding mortality.

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.

The direct thrombin inhibitor bivalirudin has been found to be noninferior to heparin plus planned glycoprotein (GP) IIb/IIIa blockade in the prevention of acute ischemic end points and 1-year mortality after percutaneous coronary intervention (PCI) with bare metal stents. We investigated whether long-term outcomes after bivalirudin use remained comparable to heparin plus GP IIb/IIIa blockade in current clinical practice of drug-eluting stent use.Using the 2004-2005 Cornell Angioplasty Registry, we studied 2504 consecutive patients undergoing urgent or elective PCI with periprocedural use of bivalirudin or heparin plus GP IIb/IIIa platelet inhibitors. Patients presenting with an acute ST-elevation myocardial infarction (MI)or = 24 hours, thrombolytic therapyor = 7 days, hemodynamic instability/shock, or renal insufficiency were excluded.Of the study cohort, 1340 patients (54%) received bivalirudin and 1164 patients (46%) received heparin plus GP IIb/IIIa blockade. The incidence of inhospital mortality (0.3% vs 0.2%, P = .692), MI (6.6% vs 8.1%, P = .191), and combined end point of death, stroke, emergent coronary artery bypass graft/PCI, and MI (6.9% vs 8.3%, P = .199) was similar in the bivalirudin and heparin plus GP IIb/IIIa inhibitor groups. There was a lower incidence of major (0.7% vs 1.9%, P = .012) and minor bleeding (9.6% vs 15.6%, P.001) in the bivalirudin versus heparin plus GP IIb/IIIa inhibitor group. Mean clinical follow-up was 24.8 +/- 7.7 months. At follow-up, there were 87 (6.5%) deaths in the bivalirudin group versus 42 (3.6%) in the heparin plus GP IIb/IIIa inhibitor group (hazard ratio 1.87, 95% CI 1.30-2.71, P = .001). After a propensity score adjusted multivariate Cox analysis, bivalirudin use was associated with a nonsignificant trend toward increased long-term mortality (hazard ratio 1.45, 95% CI 0.98-2.16, P = .065).Compared with heparin plus GP IIb/IIIa inhibition, routine use of bivalirudin as the procedural anticoagulant in contemporary PCI with drug-eluting stents was associated with lower rates of inhospital complications and similar long-term all-cause mortality.

Health care providers are under increasing pressure to lower costs by combining diagnostic and "ad hoc" interventional coronary procedures. Despite increasing use of such a treatment strategy, its effect on periprocedural safety has not been rigorously assessed in the current stent era. Using the 2000/2001 New York State Angioplasty Registry, we compared in-hospital clinical outcomes in 47,020 patients who underwent ad hoc percutaneous coronary interventions (PCIs) versus staged procedures. Patients with previous PCIs, acute myocardial infarction within 24 hours, thrombolytic therapy within 7 days, or those presenting with hemodynamic instability or shock were excluded. Patients in the staged intervention group were more likely to have hypertension, diabetes mellitus, peripheral vascular disease, previous stroke, heart failure, renal failure, previous coronary artery bypass grafting, and a lower left ventricular ejection fraction. Mortality rate (0.4% vs 0.4%, p = 0.299), major adverse cardiac events (0.7% vs 0.8%, p = 0.199), and incidence of renal failure/dialysis (0.1% vs 0.1%, p = 0.520) during in-hospital stay did not differ significantly between the ad hoc PCI and staged groups. There was a higher rate of access site injury in the staged cohort (0.4% vs 0.3%, p = 0.011), and this trend persisted after multivariate logistic regression analysis (odds ratio 1.34, 95% confidence interval 0.99 to 1.81, p = 0.061). In addition, patients with "high-risk" features had similar in-hospital clinical outcomes after either treatment approach. In conclusion, as currently practiced in New York State, the strategy of ad hoc PCI in selected patient cohorts appears to be as safe as the strategy of staged procedures.

The aging of a population replete with risk factors for heart failure (HF) (coronary heart disease, diabetes, and hypertension) coupled with a declining age-adjusted mortality rate for coronary artery and hypertensive heart diseases has created, and will continue to create, a literal explosion in the prevalence of HF in the United States. Despite advances in maximal medical therapy, however, most patients who have symptomatic HF can expect functional impairment, interludes of worsening symptomatology, and a shortened lifespan. This article updates the use of interventional therapies for the treatment of elderly patients who have HF caused by coronary artery disease, valvular heart disease, congenital heart disease, myocardial disease, and renal vascular disease.