Early Stroke and Mortality After Percutaneous Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation.

BACKGROUND: Percutaneous endocardial left atrial appendage occlusion (LAAO) is an alternative therapy for stroke prevention in patients with atrial fibrillation who are poor candidates for oral anticoagulants. Oral anticoagulation is generally discontinued 45 days following successful LAAO. Real-world data on early stroke and mortality following LAAO are lacking. METHODS: Using International Classification of Diseases, Tenth Revision, Clinical-Modification codes, we performed a retrospective observational registry analysis to examine the rates and predictors of stroke, mortality, and procedural complications during index hospitalization and 90-day readmission among 42 114 admissions in the Nationwide Readmissions Database for LAAO between 2016 and 2019. Early stroke and mortality were defined as events occurring during index admission or 90-day readmission. Data on timing of early strokes post-LAAO were collected. Multivariable logistic regression modeling was used to ascertain predictors of early stroke and major adverse events. RESULTS: LAAO was associated with low rates of early stroke (0.63%), early mortality (0.53%), and procedural complications (2.59%). Among patients who had readmissions with strokes after LAAO, the median time from implant to readmission was 35 days (interquartile range, 9-57 days); 67% of readmissions with strokes occurred <45 days postimplant. Between 2016 and 2019, the rates of early stroke after LAAO significantly decreased (0.64% versus 0.46% P-for-trend <0.001), while early mortality and major adverse event rates were unchanged. Peripheral vascular disease and a history of prior stroke were independently associated with early stroke after LAAO. Early post-LAAO stroke rates were similar between low, medium, and high LAAO volume tertile centers. CONCLUSIONS: In this contemporary real-world analysis, the early stroke rate after LAAO was low, with the majority occurring within 45 days of device implantation. Despite an increase in LAAO procedures between 2016 and 2019, there with a significant decline in early strokes after LAAO during that period.

Left ventricular geometry predicts optimal response to percutaneous mitral repair via MitraClip: Integrated assessment by two- and three-dimensional echocardiography.

OBJECTIVES: To assess impact of left ventricular (LV) chamber remodeling on MitraClip (MClp) response. BACKGROUND: MitraClip is the sole percutaneous therapy approved for mitral regurgitation (MR) but response varies. LV dilation affects mitral coaptation; determinants of MClp response are uncertain. METHODS: LV and mitral geometry were quantified on pre- and post-procedure two-dimensional (2D) transthoracic echocardiography (TTE) and intra-procedural three-dimensional (3D) transesophageal echocardiography (TEE). Optimal MClp response was defined as ≤mild MR at early (1-6 month) follow-up. RESULTS: Sixty-seven degenerative MR patients underwent MClp: Whereas MR decreased ≥1 grade in 94%, 39% of patients had optimal response (≤mild MR). Responders had smaller pre-procedural LV end-diastolic volume (94 ± 24 vs. 109 ± 25 mL/m2 , p = 0.02), paralleling smaller annular diameter (3.1 ± 0.4 vs. 3.5 ± 0.5 cm, p = 0.002), and inter-papillary distance (2.2 ± 0.7 vs. 2.5 ± 0.6 cm, p = 0.04). 3D TEE-derived annular area correlated with 2D TTE (r = 0.59, p < 0.001) and was smaller among optimal responders (12.8 ± 2.1 cm2 vs. 16.8 ± 4.4 cm2 , p = 0.001). Both 2D and 3D mitral annular size yielded good diagnostic performance for optimal MClp response (AUC 0.73-0.84, p < 0.01). In multivariate analysis, sub-optimal MClp response was associated with LV end-diastolic diameter (OR 3.10 per-cm [1.26-7.62], p = 0.01) independent of LA size (1.10 per-cm2 [1.02-1.19], p = 0.01); substitution of mitral annular diameter for LV size yielded an independent association with MClp response (4.06 per-cm2 [1.03-15.96], p = 0.045). CONCLUSIONS: Among degenerative MR patients undergoing MClp, LV and mitral annular dilation augment risk for residual or recurrent MR, supporting the concept that MClp therapeutic response is linked to sub-valvular remodeling.

Transcatheter MitraClip repair alters mitral annular geometry - device induced annular remodeling on three-dimensional echocardiography predicts therapeutic response.

BACKGROUND: Echocardiography (echo) is widely used to guide therapeutic decision-making for patients being considered for MitraClip. Relative utility of two- (2D) and three-dimensional (3D) echo predictors of MitraClip response, and impact of MitraClip on mitral annular geometry, are uncertain. METHODS: The study population comprised patients with advanced (> moderate) MR undergoing MitraClip. Mitral annular geometry was quantified on pre-procedural 2D transthoracic echocardiography (TTE) and intra-procedural 3D transesophageal echocardiography (TEE); 3D TEE was used to measure MitraClip induced changes in annular geometry. Optimal MitraClip response was defined as ≤mild MR on follow-up (mean 2.7 ± 2.5 months) post-procedure TTE. RESULTS: Eighty patients with advanced MR underwent MitraClip; 41% had optimal response (≤mild MR). Responders had smaller pre-procedural global left ventricular (LV) end-diastolic size and mitral annular diameter on 2D TTE (both p ≤ 0.01), paralleling smaller annular area and circumference on 3D TEE (both p = 0.001). Mitral annular size yielded good diagnostic performance for optimal MitraClip response (AUC 0.72, p < 0.01). In multivariate analysis, sub-optimal MitraClip response was independently associated with larger pre-procedural mitral annular area on 3D TEE (OR 1.93 per cm2/m2 [CI 1.19-3.13], p = 0.007) and global LV end-diastolic volume on 2D TTE (OR 1.29 per 10 ml/m2 [CI 1.02-1.63], p = 0.03). Substitution of 2D TTE derived mitral annular diameter for 3D TEE data demonstrated a lesser association between pre-procedural annular size (OR 5.36 per cm/m2 [CI 0.95-30.19], p = 0.06) and sub-optimal MitraClip response. Matched pre- and post-procedural TEE analyses demonstrated MitraClip to acutely decrease mitral annular area and circumference (all p < 0.001) as well as mitral tenting height, area, and volume (all p < 0.05): Magnitude of MitraClip induced reductions in mitral annular circumference on intra-procedural 3D TEE was greater among patients with, compared to those without, sub-optimal MitraClip response (>mild MR) on followup TTE (p = 0.017); greater magnitude of device-induced annular reduction remained associated with sub-optimal MitraClip response even when normalized for pre-procedure annular circumference (p = 0.028). CONCLUSIONS: MitraClip alters mitral annular geometry as quantified by intra-procedural 3D TEE. Pre-procedural mitral annular dilation and magnitude of device-induced reduction in mitral annular size on 3D TEE are each associated with sub-optimal therapeutic response to MitraClip.

Bioprosthetic mitral valve paravalvular leak closure using intracardiac echocardiography-guided three dimensional electroanatomic mapping.

The development of paravalvular leak (PVL) following surgical replacement of an aortic or mitral valve is an uncommon complication with significant morbidity and mortality. Surgical or percutaneous repair of PVL can be technically challenging. We describe the application of intracardiac echocardiography guided 3-dimensional electroanatomic mapping to facilitate PVL closure in a symptomatic patient with a previously placed bioprosthetic mitral valve. © 2017 Wiley Periodicals, Inc.

The CLOSER trial: a multi-center study on the clinical safety and effectiveness of CloserTM VSS, a novel resorbable transfemoral vascular access sealing system.

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

A multicenter randomized trial comparing the effectiveness and safety of a novel vascular closure device to manual compression in anticoagulated patients undergoing percutaneous transfemoral procedures: The CELT ACD trial.

OBJECTIVES: This study compared the performance of Celt ACD® , a novel stainless steel based vascular closure device versus manual compression (MC) for femoral arteriotomy site hemostasis in patients undergoing percutaneous coronary procedures. BACKGROUND: Optimal access site management after percutaneous transfemoral procedures remains controversial. METHODS: Patients enrolled in this multicenter, randomized open label trial underwent 6-F diagnostic or interventional procedures and were assigned 2:1 to Celt ACD® versus MC. All patients were on full anticoagulation. The primary efficacy end point was time to hemostasis (TTH) and the primary safety end points were 30-day incidence of major procedural and access site related complications. RESULTS: The trial allocated 207 patients to Celt ACD® (n = 148) versus MC (n = 59) at 5 investigational sites. Baseline characteristics of the two groups were similar. Median TTH was 0 (Interquartile range (IQR): 0, 0.33) in the Celt ACD® compared to 8 min (IQR: 0, 20; P < 0.0001) in the MC group. Procedural success was 99.3% in the Celt ACD® versus 98.1% in the MC group (P = NS). There was a single major adverse event due to device maldeployment and embolization with successful percutaneous retrieval. The 30-day major complication rate was 0.7% in the Celt ACD® and 0% in the MC group (P = NS). CONCLUSIONS: After 6-F percutaneous invasive procedures in fully anticoagulated patients, TTH was significantly reduced in patients assigned to Celt ACD® compared to patients managed with MC. The 30-day rates of vascular complications were similarly low in both groups. (CELT ACD Trial; NCT01600482) © 2017 Wiley Periodicals, Inc.

Five-year mortality outcomes in patients with chronic kidney disease undergoing percutaneous coronary intervention.

OBJECTIVE: To examine peri-procedural and long-term outcomes in patients with chronic kidney disease (CKD) undergoing percutaneous coronary interventions (PCI). BACKGROUND: Patients with advanced CKD are considered high risk when undergoing PCI. Limited published data exist on quantifying risk and assessment of long-term outcomes after PCI in this group. METHODS: Examining the Cornell Coronary Registry, we prospectively collected data of 6,478 consecutive patients who underwent elective or urgent PCI between 2009 and 2013. Patients were grouped into CKD stages by estimated glomerular filtration rate (eGFR) according to KDOQI guidelines. Procedural and 30-day outcomes are reported with assessment of long-term differences in 5-year all-cause mortality. RESULTS: Patients were grouped by CKD stages: 1,351 patients with eGFR ≥90 mL/min/1.73 m2 (stage 1), 2,882 with eGFR 60-89 (stage 2), 1,742 with eGFR 30-59 (stage 3), 191 with eGFR 15-29 (stage 4), and 312 with eGFR <15 or on dialysis (stage 5). The incidence of post-procedural acute heart failure, stroke, new dialysis requirement, transfusions, and bleeding events were higher in patients with greater CKD stage (P < 0.05). Five-year Kaplan-Meier overall survival among CKD stages 1-5 was 98.1, 95.5, 91.8, 82.5, and 76.9%, respectively (P < 0.001 by log-rank test). The hazard ratios of all-cause mortality for CKD stages 2-5 as compared to stage 1 by multivariate Cox regression analysis were as follows: 1.32 (P = 0.26), 2.04 (P < 0.01), 2.79 (P < 0.01), and 5.49 (P < 0.001). CONCLUSION: Among patients undergoing PCI, lower GFR is associated with decreased long-term survival. © 2016 Wiley Periodicals, Inc.

Prognostic Importance of Diastolic Dysfunction in Relation to Post Procedural Aortic Insufficiency in Patients Undergoing Transcatheter Aortic Valve Replacement.

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

Impact of Paravalvular Aortic Insufficiency on Left Ventricular Remodeling and Mortality after Transcatheter Aortic Valve Replacement.

BACKGROUND: 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. METHODS: 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. RESULTS: PAR ≥moderate was associated with increased mortality (HR 4.58 [1.80-11.63], p = 0.001), but PAR >mild was not. The LVIDd and LVIDs were persistently increased at one year after TAVR in patients with PAR >mild 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. CONCLUSIONS: A worse PAR was associated with more adverse LV remodeling and a higher mortality after TAVR in a non-PARTNER patient population.

Trends in hospital treatments for peripheral arterial disease in the United States and association between payer status and quality of care/outcomes, 2007-2011.

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

Intra- and Inter-Observer Reproducibility of Transcatheter Aortic Valve Replacement Planning Measurements by Multidetector Computed Tomography.

BACKGROUND AND AIM OF THE STUDY: 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. METHODS: 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. RESULTS: 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. CONCLUSION: Inter- and intra-observer measurements of the pre-TAVR planning parameters are reliable, with generally a high degree of agreement.

Nationwide trends of balloon pulmonary angioplasty and pulmonary thromboendarterectomy for chronic thromboembolic pulmonary hypertension (2012-2019).

Chronic thromboembolic pulmonary hypertension (CTEPH) is a sequela of a pulmonary embolus that occurs in approximately 1%-3% of patients. Pulmonary thromboendoarterectomy (PTE) can be a curative procedure, but balloon pulmonary angioplasty (BPA) has emerged as an option for poor surgical candidates. We used the National Inpatient Sample to query patients who underwent PTE or BPA between 2012 and 2019 with CTEPH. The primary outcome was a composite of in-hospital mortality, myocardial infarction, stroke, tracheostomy, and prolonged mechanical ventilation. Outcomes were compared between low- and high-volume centers, defined as 5 and 10 procedures per year for BPA and PTE, respectively. During our study period, 870 BPA and 2395 PTE were performed. There was a 328% relative increase in the number of PTE performed during the study period. Adverse events for BPA were rare. There was an increase in the primary composite outcome for low-volume centers compared to high-volume centers for PTE (24.4% vs. 12.1%, p = 0.003). Patients with hospitalizations for PTE in low-volume centers were more likely to have prolonged mechanical ventilation (20.0%% vs. 7.2%, p < 0.001) and tracheostomy (7.8% vs. 2.6%, p = 0.017). In summary, PTE rates have been rising over the past 10 years, while BPA rates have remained stable. While adverse outcomes are rare for BPA, patients with hospitalizations at low-volume centers for PTE were more likely to have adverse outcomes. For patients undergoing treatment of CTEPH with BPA or PTE, referral to high-volume centers with multidisciplinary teams should be encouraged for optimal outcomes.

Transcatheter mitral valve implantation: Implications of interventional technique and 3D echocardiography for complex valve-in-valve paravalvular leak.

Transcatheter mitral valve replacement (TMVR) has emerged as a feasible alternative to surgical reoperation in failed bioprostheses and rings. Residual mitral regurgitation following TMVR can present as a valve-in-valve paravalvular leak (PVL) and is associated with increased morbidity and mortality. Current therapies for valve-in-valve PVL are limited. We present a case of a symptomatic patient with severe valve-in-valve PVL after TMVR for a previous surgical bioprosthesis leak, who then underwent a second TMVR as a valve-in-valve-in-valve implantation with a 29 mm Edwards® SAPIEN 3 valve via transseptal approach using three-dimensional (3D) echocardiography. This unique case highlights the complexity of this clinical entity and recognizes 3D transesophageal echocardiography as a valuable tool to guide valve-in-valve PVL closures.

Percutaneous closure of giant aneurysmal coronary artery-to-coronary sinus fistulae with guidance from three-dimensional printed models: a case series.

Background: Coronary artery fistulae are abnormal communications of coronary arteries with systemic vasculature, pulmonary vasculature, or cardiac chambers. Use of multimodality imaging can be paramount to understanding anatomical and functional features of these complex vascular lesions, therefore optimizing success of potential curative interventions. Case summary: We present two patients with incidentally discovered giant aneurysmal coronary arteries with distal fistulous connections to the coronary sinus, which were successfully closed percutaneously with Amplatzer Septal Occluders using the assistance of three-dimensional (3D) printed heart models. Conclusion: Computed tomography-guided reconstruction with 3D multiplanar, multicolour printed models can help augment visuospatial understanding of the size, origin, course, and drainage of giant aneurysmal coronary artery-to-coronary sinus fistulae, and with manual bench testing can assist with choosing accurately sized and shaped devices for closure.

Prognostic value of cardiac troponin-I or troponin-T elevation following nonemergent percutaneous coronary intervention: a meta-analysis.

OBJECTIVES: The aim of this meta-analysis was to assess the prevalence and prognostic value regarding mortality of cTnT or cTnI elevations after nonemergent percutaneous coronary intervention (PCI) in a large number of cohort/registry studies. BACKGROUND: Routine cardiac troponin measurement after elective PCI has been controversial among interventionalists. Recent studies have provided conflicting data in regard to predictive value of cardiac troponin-T (cTnT) and troponin-I (cTnI) elevation after non-emergent PCI. METHODS: Electronic and manual searches were conducted of all published studies reporting on the prognostic impact of cTnT or cTnI elevation after elective PCI. A meta-analysis was performed with all-cause mortality at follow-up as the primary endpoint. RESULTS: We identified 22 studies, involving 22,353 patients, published between 1998 and 2009. Postprocedural cTnT and cTnI were elevated in 25.9% and 34.3% of patients, respectively. Follow-up period ranged from 3 to 67 months (mean: 17.7 ± 14.9 months). The results showed no heterogeneity among the trials (Q-test: 25.39; I(2) : 17%; P = 0.23). No publication bias was detected (Egger's test: P = 0.16). The long-term all-cause mortality in patients with cTnI or cTnT elevation after PCI (5.8%) was significantly higher when compared to patients without cTnI or cTnT elevation (4.4%); OR 1.45 (95% CI: 1.22-1.72), P < 0.01. In addition, the postprocedural composite adverse clinical events of all-cause mortality or myocardial infarction (MI) in patients with cTnI or cTnT elevation after PCI (9.2%) was significantly higher when compared to patients without cTnI or cTnT elevation (5.3%); OR 1.77 (95% CI: 1.48-2.11), P < 0.01. CONCLUSIONS: The current meta-analysis indicates that cTnI or cTnT elevation after nonemergent PCI is indicative of an increase in long-term all-cause mortality as well as the composite adverse events of all-cause mortality and MI. Efforts to routinely monitor periprocedural cTn levels along with more intensive outpatient monitoring/treatment of patients with cTn elevations may help to improve the long-term adverse outcomes in these patients following non-emergent PCI.

Thirty-Day Readmission Rates after Takotsubo Syndrome with or without Malignancy: A Nationwide Readmissions Database Analysis.

The association between malignancy and readmission after Takotsubo syndrome (TTS) hospitalization has not been fully described. We sought to examine the rates, cause, and cost of 30-day readmissions of TTS, with or without malignancy, by utilizing Nationwide Readmissions Databases from 2010 to 2014. We identified 61,588 index hospitalizations for TTS. TTS patients with malignancy tended to be older (70.6 ± 0.2 vs. 66.1 ± 0.1, p < 0.001), and the overall burden of comorbidities was higher than in those without malignancy. TTS patients with malignancy had significantly higher 30-day readmission rates than those without malignancy (15.9% vs. 11.0%; odds ratio (OR), 1.35; 95% confidence interval (CI), 1.18-1.56). Non-cardiac causes were the most common causes of readmission for TTS patients with malignancy versus without malignancy (75.5% vs. 68.1%, p < 0.001). The 30-day readmission rate due to recurrent TTS was very low in both groups (0.4% and 0.5%; p = 0.47). The total costs were higher by 25% (p < 0.001) in TTS patients with vs. without malignancy. In summary, among patients hospitalized with TTS, the presence of malignancy was associated with increased risk of 30-day readmission and increased costs. These findings highlight the importance of optimized management for TTS patients with malignancy.

Efficacy and safety of bivalirudin in patients receiving clopidogrel therapy after diagnostic angiography for percutaneous coronary intervention in acute coronary syndromes.

OBJECTIVES: This study sought to investigate if the efficacy of bivalirudin monotherapy is similar to heparin plus GP IIb/IIIa inhibition in patients with acute coronary syndromes (ACS) treated with clopidogrel following diagnostic angiography. BACKGROUND: Prior trials have demonstrated that peri-procedural bivalirudin therapy confers similar efficacy as heparin plus GP IIb/IIIa inhibitors, while lowering the risk of bleeding complications in ACS patients undergoing percutaneous coronary interventions (PCI). However, the incidence of adverse ischemic events post-PCI appeared to be higher in patients receiving bivalirudin without adequate pretreatment with clopidogrel. METHODS: Using the 2004/2005 Cornell Angioplasty Registry, we evaluated 980 consecutive patients undergoing urgent PCI for UA/NSTEMI who were treated with either bivalirudin or UFH plus GP IIb/IIIa inhibitor. We excluded patients who were on chronic clopidogrel therapy or received clopidogrel pretreatment prior to angiography. All patients received a clopidogrel load (≥300-mg dose) immediately before or after the PCI. Long-term all-cause mortality was obtained for 100% of patients, with a mean follow-up of 24.6 ± 7.7 months. RESULTS: Of the 980 study patients, 461 (47.0%) were treated with bivalirudin and 519 (53.0%) patients received UFH plus GP IIb/IIIa inhibitor. DES were used in 88% of PCI; 45% of patients presented with NSTEMI. The incidence of in-hospital death (0.4% vs. 0.2%, P = 0.604), post-procedural MI (6.9% vs. 5.4%, P = 0.351), and MACE including death, stroke, emergent CABG/PCI, and MI (7.6% vs. 5.8%, P = 0.304) were similar in patients treated with bivalirudin versus UFH plus GP IIb/IIIa inhibitors, respectively. The incidence of in-hospital stent thrombosis was similar (0.7% vs. 0%, P = 0.104), while major (0.9% vs. 2.9%, P = 0.034) and minor bleeding (10.4% vs. 18.9%, P < 0.001) was reduced in the bivalirudin-treated group. By two-years of follow-up, after propensity-score adjusted multivariate Cox regression analysis, there was no significant difference in long-term mortality between the two groups (HR 1.18; 95%CI 0.64-2.19, P = 0.598). CONCLUSIONS: In patients presenting with ACS and receiving clopidogrel treatment after angiography (before or within 30 min of PCI), peri-procedural bivalirudin monotherapy suppresses acute and long-term adverse events to a similar extent as does UFH plus GP IIb/IIIa inhibitors, while significantly lowering the risk of bleeding complications.

Associations Between Hospital Length of Stay, 30-Day Readmission, and Costs in ST-Segment-Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention: A Nationwide Readmissions Database Analysis.

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<0.001) and the non-AW STEMI group (P<0.001). 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.

Tricuspid Stenosis in Pregnancy: A Valve-in-Valve Conundrum.

Redo tricuspid valve replacement has high surgical operative mortality. Transcatheter valve-in-valve provides a viable option for valve replacement. We discuss the decision-making process involved in performing transcatheter tricuspid valve-in-valve replacement in a 23-week pregnant woman with multiple comorbidities and symptomatic severe bioprosthetic stenosis. (Level of Difficulty: Intermediate.).

The Influence of Gender on In-Hospital Clinical Outcome Following Isolated Mitral or Aortic Heart Valve Surgery.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. SUMMARY FOR THE ANNOTATED TABLE OF CONTENTS: 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.