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.

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.

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.

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.

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.).

Impact of Aortomitral Continuity Calcification on Need for Permanent Pacemaker After Transcatheter Aortic Valve Replacement.

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<0.0001), as well as higher median AMCC score (263 versus 0; P<0.0001). There was no difference in aortic valve calcification and mitral annular calcification between patients with and without PPMI (all 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.

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.

In-Hospital Bleeding Outcomes of Myocardial Infarction in the Era of Warfarin and Direct Oral Anticoagulants for Atrial Fibrillation in the United States: A Report From the National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network Registry.

Background We sought to examine patient characteristics, peri-infarction invasive and pharmacologic management, and in-hospital major bleeding in myocardial infarction patients with atrial fibrillation or flutter, based on home anticoagulant use. Methods and Results We stratified patients by home anticoagulant: (1) no anticoagulant, (2) warfarin, and (3) direct oral anticoagulants ( DOAC s) among ST-segment-elevation myocardial infarction ( STEMI ) and non-STEMI (NSTEMI) patients with atrial fibrillation or flutter treated at 761 US hospitals in the ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry from January 2015 to December 2016. The primary outcome of our study was in-hospital major bleeding. Multivariable logistic regression was used to examine the independent association between home anticoagulant and in-hospital major bleeding. Among 6471 STEMI patients with atrial fibrillation or flutter, 15.7% were on warfarin and 13.0% on DOAC s; among 19 954 NSTEMI patients, 22.8% were on warfarin and 15.4% on DOAC s. In STEMI , door-to-balloon times were slightly higher in those on anticoagulant, with similar rates of angiography within 24 hours in the 3 groups. NSTEMI patients on anticoagulant were less likely to undergo angiography (49.3% no anticoagulant, 33.4% on warfarin, 36.4% on DOAC s; P<0.01) or percutaneous coronary intervention within 24 hours (21.1% no anticoagulant, 14.3% on warfarin, 15.9% on DOAC s; P<0.01). After multivariate adjustment, use of home warfarin (odds ratio: 1.00 [95% CI , 0.79-1.27] in STEMI and 1.13 [95% CI , 0.97-1.30] in NSTEMI ) or DOAC (odds ratio: 0.93 [95% CI , 0.73-1.20] in STEMI and 0.97 [95% CI , 0.81-1.16] in NSTEMI ) was not associated with increased in-hospital major bleeding compared with no anticoagulant. Conclusions In routine clinical practice, home warfarin or DOAC therapy is not associated with an increased risk of in-hospital bleeding compared with no anticoagulant.

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.

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.

Thirty-Day Readmission Rates, Timing, Causes, and Costs after ST-Segment-Elevation Myocardial Infarction in the United States: A National Readmission Database Analysis 2010-2014.

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<0.001). Female sex, 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<0.001). 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.

Absence of electrocardiographic left ventricular hypertrophy is associated with increased mortality after transcatheter aortic valve replacement.

BACKGROUND: Electrocardiographic (ECG) left ventricular hypertrophy (LVH) has been associated with increased mortality in patients with asymptomatic aortic stenosis (AS) and hypertension. However, patients with symptomatic AS undergoing transcatheter aortic valve replacement (TAVR) have higher percentages of myocardial fibrosis or amyloidosis that have been associated with decreased ECG voltage and worse outcomes. HYPOTHESIS: We tested the hypothesis that baseline ECG LVH is independently associated with increased all-cause mortality after TAVR. METHODS: A total of 231 patients (96 men; mean age 84.7 ± 7.8 years) that underwent TAVR at our institution were included. Cornell voltage, defined as SV3 + RaVL, was used to assess for presence of ECG LVH using gender-specific cut-off values. We used the Kaplan-Meier estimator to derive survival curves. Multivariate Cox regression analysis was used to compare mortality between patients without vs with ECG LVH and adjust for echocardiographic LVH and predictors of mortality in this cohort. RESULTS: Over a follow-up time of 16.3 ± 10.4 months, the absence of ECG LVH was significantly associated with increased mortality (40.4% vs 23.6% at 2-years, log rank P = 0.003). After adjusting for echocardiographic LVH and predictors of mortality in our cohort, the absence of ECG LVH remained a predictor of increased mortality (HR = 1.79, CI 95% 1.02-3.14, P = 0.042). CONCLUSIONS: The absence of ECG LVH was independently associated with increased mortality in patients undergoing TAVR. Baseline ECG may have an important prognostic role in these patients and could lead to further testing to evaluate for myocardial fibrosis or amyloidosis.

Temporal Trends in the Clinical Acuity of Patients with ST-Segment Elevation Myocardial Infarction.

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 ratioyear 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%, Ptrend < .001). Intubation or cardiac arrest on presentation increased from 3.2% to 7.8% (Ptrend < .001) and had a strong, independent association with mortality. After multivariable adjustment using a model that incorporated the increasing trend in intubation/cardiac arrest, mortality decreased over time (odds ratioyear 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.

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.

Characteristics of hospitalizations for cardiogenic shock after acute myocardial infarction in the United States.

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% (ptrend<0.001). In a multivariate analysis, mortality rates in 2011-2012 versus 2005-2006 decreased significantly (OR: 0.75; 95% CI: 0.65-0.85, p<0.001). 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.

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.

Comparison of Trends and In-Hospital Outcomes of Concurrent Carotid Artery Revascularization and Coronary Artery Bypass Graft Surgery: The United States Experience 2004 to 2012.

OBJECTIVES: The aim of this study was to compare trends and outcomes of 3 approaches to carotid revascularization in the coronary artery bypass graft (CABG) population when performed during the same hospitalization. BACKGROUND: The optimal approach to managing coexisting severe carotid and coronary disease remains controversial. Carotid endarterectomy (CEA) or carotid artery stenting (CAS) are used to decrease the risk of stroke in patients with carotid disease undergoing CABG surgery. METHODS: The authors conducted a serial, cross-sectional study with time trends of 3 revascularization groups during the same hospital admission: 1) combined CEA+CABG; 2) staged CEA+CABG; and 3) staged CAS+CABG from the Nationwide Inpatient Sample database 2004 to 2012. The primary composite endpoints were in-hospital all-cause death, stroke, and death/stroke. RESULTS: During the 9-year period, 22,501 concurrent carotid revascularizations and CABG surgeries during the same hospitalization were performed. Of these, 15,402 (68.4%) underwent combined CEA+CABG, 6,297 (28.0%) underwent staged CEA+CABG, and 802 (3.6%) underwent staged CAS+CABG. The overall rate of CEA+CABG decreased by 16.1% (ptrend = 0.03) from 2004 to 2012, whereas the rate of CAS+CABG did not significantly change during these years (ptrend = 0.10). The adjusted risk of death was greater, whereas risk of stroke was lower with both combined CEA+CABG (death odds ratio [OR]: 2.08, 95% confidence interval [CI]: 1.08 to 3.97; p = 0.03; stroke OR: 0.65, 95% CI: 0.42 to 1.01; p = 0.06) and staged CEA+CABG (death OR: 2.40, 95% CI: 1.43 to 4.05; p = 0.001; stroke OR: 0.50, 95% CI: 0.31 to 0.80; p = 0.004) approaches compared with CAS+CABG. The adjusted risk of death or stroke was similar in the 3 groups. CONCLUSIONS: In patients with concomitant carotid and coronary disease undergoing combined revascularization, combined CEA+CABG is utilized most frequently, followed by staged CEA+CABG and staged CAS+CABG strategies. The staged CAS+CABG strategy was associated with lower risk of mortality, but higher risk of stroke. Future studies are needed to examine the risks/benefits of different carotid revascularization strategies for high-risk patients requiring concurrent CABG.