Impact of periprocedural bleeding on mid-term outcome in nonagenarians who underwent transcatheter aortic valve implantation: insights from LAPLACE registry.

Data from several recent studies have demonstrated the safety and efficacy of transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) even in nonagenarians. However, the impact of periprocedural bleeding following TAVI on their outcome remains unclear. In the aLliAnce for exPloring cLinical prospects of AortiC valvE disease (LAPLACE) registry, we compared outcomes between the bleeding and no-bleeding groups among 1953 patients < 90 years old (mean age, 83.0 ± 4.6 years old) and 316 nonagenarians (mean age, 91.7 ± 1.9 years old) who underwent TAVI with a median follow-up period of 628 days. The group with any periprocedural bleeding showed a higher 30-day mortality than the no-bleeding group in patients < 90 years old (3.3% vs. 0.5%, p = 0.001) and nonagenarians (7.9% vs. 0.7%, p = 0.001). In patients < 90 years old, severe periprocedural bleeding (n = 85) was associated with a higher mid-term all-cause mortality rate than no severe bleeding (n = 1,868), even after adjusting for covariates (hazard ratio [HR], 1.994; 95% confidence interval [CI] 1.287-2.937; p = 0.002). On the other hand, in nonagenarians, any periprocedural bleeding (n = 38) was associated with a higher mid-term cardiovascular (CV) mortality rate (21.1% vs. 4.3%, log-rank p = 0.014) than no bleeding (n = 278), even after adjusting for covariates (HR, 3.104; 95% CI 1.140-8.449; p = 0.027). In conclusion, any periprocedural bleeding after TAVI was associated with mid-term CV mortality in nonagenarians, whereas severe bleeding was associated with mid-term all-cause mortality in patients < 90 years old.

A novel "proximal first" Inoue balloon catheter for retrograde aortic valvuloplasty: Initial case report.

The Inoue balloon, invented for percutaneous transseptal mitral commissurotomy for mitral stenosis, is initially dilated in the distal portion and then the proximal portion, forming an hourglass shape that stabilizes the balloon at the mitral valve orifice with a pulling action. The device has been successfully applied to antegrade aortic valvuloplasty; the hourglass shape stabilizes the balloon across the aortic valve without rapid ventricular pacing. Subsequently, an Inoue balloon was developed for retrograde aortic valvuloplasty using the same design as the antegrade balloon. The hourglass-shaped balloon, however, has difficulty maintaining stability across the aortic valve because the distal portion of the balloon, which inflates first, directly receives systolic pressure from the left ventricle. A novel Inoue balloon was invented to overcome this issue by altering the manner of inflation: the proximal portion inflates first, followed by the distal portion. Theoretically, the proximal portion, which initially inflates just above the aortic valve, remains secure across the valve by applying a pressing force that counteracts the systolic forward pressure. Furthermore, a radiopaque marker is placed at the center of the balloon to enable rapid and precise balloon adjustment. We present a case involving a 65-year-old female hemodialysis patient with severe symptomatic aortic stenosis who we successfully treated with balloon aortic valvuloplasty using the novel Inoue balloon followed by transcatheter aortic valve implantation. The present case demonstrates the feasibility and effectiveness of the novel "proximal first" Inoue balloon for retrograde balloon aortic valvuloplasty for severe aortic stenosis.

Potent P2Y12 inhibitors versus Clopidogrel in elderly patients with acute coronary syndrome: Systematic review and meta-analysis.

BACKGROUND: Potent P2Y12 inhibitors reduce cardiovascular events but increase bleeding in patients presenting with acute coronary syndrome (ACS). Elderly patients are at increased risk of bleeding and whether the benefit-risk ratio of potent P2Y12 inhibitors remains favorable is not known. OBJECTIVES: To investigate the efficacy and safety of potent P2Y12 inhibitors versus clopidogrel in elderly patients with ACS. METHODS: PUBMED and EMBASE were searched through July 2020 for randomized control trials (RCTs) or subgroup analyses of RCTs investigating potent P2Y12 inhibitors (prasugrel or ticagrelor) or clopidogrel in elderly (age ≥ 65 years) patients with ACS. The primary outcome was major adverse cardiovascular events (MACE). RESULTS: Our search identified 9 RCTs with a total of 10,792 elderly patients. When compared with clopidogrel, potent P2Y12 inhibitors had similar risk of MACE (hazard ratio (HR): 0.94; 95%; confidence interval (CI) [0.85-1.06], P = .31, I2 = 9%), all-cause mortality (HR: 0.89; 95% CI [0.74-1.07], P = .22, I2 = 29%), reduced the risk of cardiovascular death (HR: 0.82; 95% CI [0.68-0.98], P = .03, I2 = 16%) but increased the risk of major bleeding (HR: 1.27; 95% CI [1.04-1.56], P = .02, I2 = 0%). In a subgroup analysis, ticagrelor reduced all-cause mortality (HR: 0.73; 95% CI [0.55-0.98]) and cardiovascular death (HR: 0.70; 95% CI [0.54-0.90]) compared with clopidogrel. CONCLUSIONS: Among elderly patients with ACS, potent P2Y12 inhibitors reduce cardiovascular death but increase bleeding with no difference in MACE or all-cause death when compared with clopidogrel. Further RCTs are needed to refine P2Y12 inhibitor selection for elderly patients with ACS.

Safety and efficacy of mechanical circulatory support with Impella or intra-aortic balloon pump for high-risk percutaneous coronary intervention and/or cardiogenic shock: Insights from a network meta-analysis of randomized trials.

BACKGROUND: Mechanical circulatory support (MCS) with Impella or intra-aortic balloon pump (IABP) is used for high-risk percutaneous coronary intervention (PCI) and/or for cardiogenic shock (CS) due to acute myocardial infarction. We aimed to investigate the efficacy and safety of Impella or IABP when compared with no MCS using a network meta-analysis of randomized controlled trials (RCTs). METHODS: EMBASE and MEDLINE were searched through February 2020 for RCT evaluating efficacy of Impella vs. IABP vs. no MCS in patients undergoing high-risk PCI or CS. The primary efficacy outcome was 30 day or in-hospital all-cause mortality whereas the primary safety outcomes were major bleeding and vascular complications. RESULTS: Our search identified nine RCTs enrolling a total of 1,996 patients with high-risk PCI and/or CS. There was no significant difference with Impella or IABP on all-cause mortality when compared with no MCS (Impella vs. no MCS; OR:0.82 [0.35-1.90], p = .65, IABP vs. no MCS; OR:0.77 [0.47-1.28], p = .31, I2 = 18.1%). Impella significantly increased major bleeding compared with no MCS (Impella vs. no MCS; OR:7.01 [1.11-44.4], p = .038, I2 = 19.2%). IABP did not increase the risk of major bleeding compared with no MCS (OR:1.27 [0.75-2.16], p = .38, I2 = 19.2%) but increased vascular complication compared with no MCS (OR:1.92 [1.01-3.64], p = .045, I2 = 1.5%). CONCLUSIONS: Neither Impella nor IABP decreased all-cause short-term mortality when compared with no MCS for high-risk PCI and/or CS. Moreover, Impella increased major bleeding compared with no MCS.

Incidence and clinical outcomes of bleeding complications and acute limb ischemia in STEMI and cardiogenic shock.

BACKGROUND: Bleeding complications and acute limb ischemia (ALI) are devastating vascular complications in patients with ST-segment elevation myocardial infarction (STEMI). Cardiogenic shock (CS) can further increase this risk due to multiorgan failure. In the contemporary era, percutaneous mechanical circulatory support is commonly used for management of CS. We hypothesized that vascular complications may be an important determinant of clinical outcomes for CS due to STEMI (CS-STEMI). OBJECTIVE: We evaluated 10-year national trends, resource utilization and outcomes of bleeding complications, and ALI in CS-STEMI. METHODS: We performed a retrospective cohort study of CS-STEMI patients from a large U.S. national database (National Inpatient Sample) between 2005 and 2014. Events were then divided into four different groups: no MCS, with intra-aortic balloon pump, percutaneous ventricular assist device includes Impella or Tandem Heart or extracorporeal membrane oxygenation. RESULTS: Bleeding complications and ALI were observed in 31,389 (18.2%) and 1,628 (0.9%) out of 172,491 admissions with CS-STEMI, respectively. Between 2005 and 2014, overall trends increased for ALI; however, the number of bleeding events decreased. ALI was associated with increased in-hospital mortality in comparison to those without any ALI. However, bleeding complications were not associated with increased in-hospital mortality. Compared to patients without complications, both bleeding and ALI were associated with increased length of stay (LOS) and hospitalization costs. CONCLUSIONS: Bleeding and ALI are common complications associated with CS-STEMI in the contemporary era. Both complications are associated with increased hospital costs and LOS. These findings highlight the need to develop algorithms focused on vascular safety in CS-STEMI.

Incidence and clinical outcomes of stroke in ST-elevation myocardial infarction and cardiogenic shock.

OBJECTIVE: The authors sought to evaluate 10-year national trends, incidence and clinical outcomes of stroke in CS-STEMI. BACKGROUND: Stroke is a devastating complication among patients with ST-elevation myocardial infarction (STEMI). Concomitant cardiogenic shock (CS) may further increase the risk of stroke. Use of percutaneous mechanical circulatory support (pMCS) devices may further increase stroke risk in CS-STEMI. No studies have evaluated the risk of stroke in contemporary CS-STEMI. METHODS: We performed a retrospective cohort study of CS-STEMI patients from a large U.S. national database between 2005 and 2014. Previously validated codes for stroke were used to identify events of ischemic or hemorrhagic stroke. They were then divided into different groups: without MCS, with intra-aortic balloon pump, percutaneous ventricular assist device (PVAD, includes Impella or TandemHeart devices), or extracorporeal membrane oxygenation. RESULTS: In 172,491 admissions, stroke was noted in 5,613 (3.2%). Between 2005 and 2014, we observed an increase in the events of overall stroke from 3.1% in 2005 to 5.0% in 2014 (p for the trend <.001). The number of ischemic stroke events (2.4%) was higher than hemorrhagic stroke (0.1%) during the study period. Presence of stroke was associated with higher in-hospital mortality (40.6 vs. 29.8%, 95% CI adjusted odds ratio: 1.57, 1.44-1.67; p < .0001 among stroke vs. without stroke). CONCLUSIONS: The incidence of stroke events in CS-STEMI patients increased between 2005 and 2014, and is associated with higher in-hospital mortality, length of stay, and cost of hospitalization. The incidence of both hemorrhagic and ischemic stroke was higher with pMCS device use. Stroke prevention is a priority for CS-STEMI patients.

Palliative care consultation in patients with Staphylococcus aureus bacteremia.

BACKGROUND: Palliative care consultation has shown benefits across a wide spectrum of diseases, but the utility in patients with Staphylococcus aureus bacteremia remains unclear despite its high mortality. AIM: To examine the frequency of palliative care consultation and factors associated with palliative care consult in Staphylococcus aureus bacteremia patients in the United States. DESIGN: A population-based retrospective analysis using the Nationwide Inpatient Sample database in 2014, compiled by the Healthcare Costs and Utilization Project of the Agency for Healthcare Research and Quality. SETTING/SUBJECTS: All inpatients with a discharge diagnosis of Staphylococcus aureus bacteremia (ICD-9-CM codes; 038.11 and 038.12). MEASUREMENTS: Palliative care consultation was identified using ICD-9-CM code V66.7. Patients' baseline characteristics and outcomes were compared between those with and without palliative care consult. RESULTS: A total of 111,320 Staphylococcus aureus bacteremia admissions were identified in 2014. Palliative care consult was observed in 8140 admissions (7.3%). Palliative care consultation was associated with advanced age, white race, comorbidities, higher income, teaching/urban hospitals, Midwest region, Methicillin-resistant Staphylococcus aureus bacteremia and the lack of echocardiogram. Palliative care consult was also associated with shorter but more expensive hospitalizations. Crude mortality was 53% (4314/8140) among admissions with palliative care consult and 8% (8357/10,3180) among those without palliative care consult (p < 0.001). CONCLUSIONS: Palliative care consultation was infrequent during the management of Staphylococcus aureus bacteremia, and a substantial number of patients died during their hospitalizations without palliative care consult. Given the reported benefit in other medical conditions, palliative care consultation may have a role in Staphylococcus aureus bacteremia. Selecting patients who may benefit the most should be explored.

Transcatheter versus surgical aortic valve replacement in patients with chronic obstructive pulmonary disease.

Although a number of studies compared mortality after transcatheter aortic valve implantation (TAVI) with that after surgical aortic replacement (SAVR) in patients with chronic obstructive pulmonary disease (COPD), no meta-analysis of them has been conducted to date. To determine whether TAVI or SAVR is associated with better postprocedural survival in patients with COPD, a meta-analysis of all studies currently available was performed. Design. To identify all comparative studies of TAVI with SAVR in patients with COPD, PubMed and Web of Science were searched through January 2020. Studies meeting the following criteria were included in the present meta-analysis: the design was an observational comparative study or a randomized controlled trial; the study population was patients with COPD; patients were assigned to TAVI versus SAVR; and outcomes included all-cause mortality. Adjusted (if unavailable, unadjusted) odds or hazard ratios with their confidence intervals (CIs) of mortality for TAVI versus SAVR were extracted from each study. Study-specific estimates were combined in the random-effects model. Results. Six eligible studies with a total of 4771 patients with COPD were identified and included in the present meta-analysis. The meta-analysis indicated significantly lower early (in-hospital or 30-day) mortality after TAVI than after SAVR (odds ratio, 0.69; 95% CI, 0.53-0.90; p = .006) but no significant difference in midterm (1-year to 5-year) mortality between TAVI and SAVR (hazard ratio, 1.07; 95% CI, 0.79-1.44; p = .68). Conclusions. In patients with COPD, TAVI was associated with reduced early mortality, while midterm mortality appeared similar, as compared with SAVR.

Antithrombotic strategies after transcatheter aortic valve implantation: Insights from a network meta-analysis.

OBJECTIVES: We aimed to investigate the efficacy and safety of different antithrombotic strategies in patients undergoing transcatheter aortic valve implantation (TAVI) using network meta-analyses. BACKGROUND: Meta-analyses comparing single antiplatelet therapy (SAPT) vs. dual antiplatelet therapy (DAPT), ± oral anticoagulant (OAC) was conducted to determine the appropriate post TAVI antithrombotic regimen. However, there was limited direct comparisons across the different therapeutic strategies. METHODS: MEDLINE and EMBASE were searched through December 2018 to investigate the efficacy and safety of different antithrombotic strategies (SAPT, DAPT, OAC, OAC + SAPT, and OAC + DAPT) in patients undergoing TAVI. The main outcome were all-cause mortality, major or life-threatening bleeding events, and stroke. RESULTS: Our search identified 3 randomized controlled trials and 10 nonrandomized studies, a total of 20,548 patients who underwent TAVI. All OACs were vitamin K antagonists. There was no significant difference on mortality except that OAC + DAPT had significantly higher rates of mortality compared with others (p < .05, I2 = 0%). SAPT had significantly lower rates of bleeding compared with DAPT, OAC+SAPT, and OAC+DAPT (hazard ratio [HR]: 0.59 [0.46-0.77], p < .001, HR: 0.58 [0.34-0.99], p = .045, HR: 0.41 [0.18-0.93], p = .033, respectively, I2 = 0%). There was no significant difference on stroke among all antithrombotic strategies. CONCLUSION: Patients who underwent TAVI had similar all-cause mortality rates among different antithrombotic strategies except OAC+DAPT. Patients on SAPT had significantly lower bleeding risk than those on DAPT, OAC + SAPT, and OAC + DAPT. Our results suggest SAPT is the preferred regimen when there is no indication for DAPT or OAC. When DAPT or OAC is indicated, DAPT + OAC should be avoided.

Increased Risk of Perioperative Ischemic Stroke in Patients Who Undergo Noncardiac Surgery with Preexisting Atrial Septal Defect or Patent Foramen Ovale.

OBJECTIVES: To evaluate whether a preoperative diagnosis of atrial septal defect (ASD) or patent foramen ovale (PFO) is associated with perioperative stroke in noncardiac surgery and their outcomes. DESIGN: Retrospective cohort analysis. SETTING: United States hospitals. PARTICIPANTS: Adults patients (≥18 years old) who underwent major noncardiac surgery from 2010 to 2015 were identified using the Healthcare Cost and Utilization Project's National Readmission Database. INTERVENTIONS: Preoperative diagnosis of ASD or patent foramen ovale. MEASUREMENTS AND MAIN RESULTS: Among the 19,659,161 hospitalizations for major noncardiac surgery analyzed, 12,248 (0.06%) had a preoperative diagnosis of ASD/PFO. Perioperative ischemic stroke occurred in 723 (5.9%) of patients with ASD/PFO and 373,291 (0.02%) of those without ASD/PFO (adjusted odds ratio [aOR], 16.7; 95% confidence interval [CI]: 13.9-20.0). Amongst the different types of noncardiac surgeries, obstetric, endocrine, and skin and burn surgery were associated with higher risk of stroke in patients with pre-existing ASD/PFO. Moreover, patients with ASD/PFO also had an increased in-hospital mortality (aOR, 4.6, 95% CI: 3.6-6.0), 30-day readmission (aOR, 1.2, 95% CI: 1.04-1.38), and 30-day stroke (aOR, 7.2, 95% CI: 3.1-16.6). After adjusting for atrial fibrillation, ischemic stroke remained significantly high in the ASD/PFO group (aOR: 23.7, 95%CI 19.4-28.9), as well as in-hospital mortality (aOR: 5.6, 95% CI 4.1-7.7), 30-day readmission (aOR: 1.19, 95%CI 1.0-1.4), and 30-day stroke (aOR: 9.3, 95% CI 3.7-23.6). CONCLUSIONS: Among adult patients undergoing major noncardiac surgery, pre-existing ASD/PFO is associated with increased risk of perioperative ischemic stroke, in-hospital mortality, 30-day stroke, and 30-day readmission after surgery.

Trends of utilization and outcomes after transcatheter and surgical aortic valve replacement on chronic dialysis.

BACKGROUND AND AIM: Trends of utilization and outcomes of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) for patients on chronic dialysis (CD) are not well described. We aimed to assess the trends in utilization and outcomes of TAVR and SAVR on CD. METHODS: Nationwide Readmission Databases from 2013 to 2017 was analyzed. International Classification of Diseases Clinical Modification 9 and 10 codes were used to identify diagnoses and procedures. A multivariable regression model was used to compare the outcomes expressed as adjusted odds ratio (aOR) and 95% confidence interval (CI). RESULTS: A total of 5731 TAVR and 6491 SAVR were performed in patients with CD, respectively. The volume of TAVR increased by approximately four-folds and SAVR increased by approximately 33%. However, amongst patients with CD, the percentage of TAVR increased, whereas that of SAVR decreased (p < .001 for all). In 2016 and 2017, TAVR volume surpassed that of SAVR on CD. In-hospital mortality remained similar in TAVR (aOR: 0.92; 95% CI: 0.79-1.07; p-trend = .23) whereas it increased significantly in SAVR (aOR: 1.14: 95% CI: 1.05-1.25, p-trend = .002). In 2017, in-hospital mortality and 30-day readmission were significantly higher in TAVR among CD than non-CD patients. CONCLUSION: Despite increased use of TAVR among CD, there still is an opportunity for improvement in outcome of aortic valve replacement for those on CD.

Prognostic impact of baseline C-reactive protein levels on mortality after transcatheter aortic valve implantation.

OBJECTIVES: To determine whether baseline C-reactive protein (CRP) levels can predict mortality after transcatheter aortic valve implantation (TAVI), we performed a meta-analysis of currently available studies. METHODS: All studies investigating the prognostic impact of baseline (preprocedural) CRP levels on all-cause mortality after TAVI were identified by means of searching PubMed and Google Scholar through May 2019. For each study, (preferentially, adjusted rather than unadjusted) odds/hazard ratios (ORs/HRs) with corresponding 95% confidence intervals of mortality per standard-deviation (SD) (or unit) increase in CRP levels or those for high vs low CRP levels. RESULTS: Our search identified 14 eligible studies including a total of 3449 patients undergoing TAVI and reporting early (in-hospital to 3-month) and midterm (1-year to 3-year) all-cause mortality after TAVI. Pooled analyses demonstrated associations of high-baseline CRP levels with a marginal, but statistically nonsignificant increase in early mortality (pooled OR/HR per SD increase in CRP levels, 2.72; P = .09 and pooled OR/HR for high vs low CRP levels, 3.32; P = .07) and a statistically significant increase in midterm mortality after TAVI (pooled OR/HR per SD increase in CRP levels, 1.45; P < .0001 and pooled OR/HR for high vs low CRP levels, 1.78; P < .00001). Excluding HRs for high-sensitivity CRP, combining ORs/HRs of 1-year mortality, pooling HRs of ≥2-year mortality, and combining adjusted HRs did not alter the primary results. CONCLUSION: High-baseline CRP levels may predict increased midterm, but not early, mortality after TAVI.

Baseline left ventricular diastolic dysfunction affects midterm mortality after transcatheter aortic valve implantation.

OBJECTIVES: To determine whether preprocedural left ventricular (LV) diastolic dysfunction impairs midterm mortality after transcatheter aortic valve implantation (TAVI) for patients with severe aortic stenosis (AS), we performed a meta-analysis of currently available evidence. METHODS: We identified all studies investigating impact of preprocedural severity of LV diastolic dysfunction on midterm (≥1-year) all-cause mortality after TAVI for patients with AS through a search of databases (MEDLINE and EMBASE) until September 2019. From each study, we extracted an adjusted (if unavailable, unadjusted) hazard ratio (HR) of midterm mortality. We pooled study-specific estimates in the random-effects model. RESULTS: Ten eligible studies with a total of 2380 patients with AS undergoing TAVI were identified. In accordance with pooled analyses, higher-grade preprocedural LV diastolic dysfunction was associated with significantly worse midterm all-cause mortality after TAVI compared to lower-grade dysfunction (HR for grade II vs I, 1.15; P = .002; HR for grade III vs I, 1.35; P = .001; HR for grade III vs II; 1.16, P = .002; HR for grade II-III vs I, II-III vs 0-I, or III vs I-II, 1.34; P < .00001 [primary meta-analysis]; HR per grade, 1.16; P = .003). No funnel plot asymmetry for the primary meta-analysis (for grade II-III vs I, II-III vs 0-I, or III vs I-II) was identified, which probably indicated no publication bias (P = .381 by the linear-regression test). CONCLUSION: Higher-grade preprocedural LV diastolic dysfunction was associated with worse midterm all-cause mortality after TAVI for patients with AS compared to lower-grade dysfunction.

Meta-Analysis of Hospital-Volume Relationship in Transcatheter Aortic Valve Implantation.

BACKGROUND: Whether a volume-outcome relationship, that is, higher volume centres have better outcomes compared with lower volume hospitals, exists in transcatheter aortic valve implantation (TAVI) has not yet been systematically explored. METHODS: We performed a systematic review and meta-analysis to evaluate whether highest or intermediate annual TAVI volume hospitals has better short-term (in-hospital or 30-days) mortality compared with the lowest volume hospitals. Odds ratio (OR) and 95% confidence interval (CI) was calculated with the Mantel-Haenszel method. RESULTS: We identified 10 publications from nine different countries including TAVI performed between 2005-2017. Included patients were mainly high-risk cohorts. We included five and six studies to assess volume-outcome relationship in the highest and intermediate volume hospitals compared with the lowest volume hospitals, respectively. Our results showed that in both the highest (OR 0.66, 95%CI 0.53-0.83, p=0.0003, I2=78%) and intermediate (OR 0.85, 95%CI 0.79-0.92, p<0.0001, I2=0%) volume hospitals, there was a statistically significant volume-outcome relationship for short-term mortality compared with the lowest volume hospitals. CONCLUSIONS: Our review suggests a significant volume-outcome relationship post-TAVI in both the highest and intermediate volume hospitals compared with the lowest volume hospitals mainly in high surgical risk patients. The high heterogeneity in this relationship between the highest and the lowest volume hospitals warrant cautious interpretation. Whether this relationship remains significant in low-risk cohort requires further study.

Meta-Analysis and Meta-Regression of Transcatheter Aortic Valve Implantation for Pure Native Aortic Regurgitation.

AIM: To assess outcomes of transcatheter aortic valve implantation (TAVI) for pure native aortic regurgitation (AR) and to evaluate whether 30-day all-cause mortality is modulated by patient characteristics, we performed a meta-analysis and meta-regression of currently available studies. METHOD: Studies enrolling ≥20 patients undergoing TAVI for AR were considered for inclusion. Study-specific estimates (incidence rates of outcomes) were combined using one-group meta-analysis in a random-effects model. Subgroup meta-analysis of studies exclusively using early-generation devices (EGD) and new-generation devices (NGD) and stepwise random-effects multivariate meta-regression were also performed. RESULTS: The search identified 11 eligible studies including a total of 911 patients undergoing TAVI for AR. Pooled analysis demonstrated an incidence of device success of 80.4% (NGD 90.2%, EGD 67.2%; p < 0.001), moderate or higher paravalvular aortic regurgitation (PAR) of 7.4% (NGD 3.4%, EGD 17.3%; p < 0.001), 30-day all-cause mortality of 9.5% (NGD 6.1%, EGD 14.7%; p < 0.001), mid-term (4 mo - 1 yr) all-cause mortality of 18.8% (NGD 11.8%, EGD 32.2%; p < 0.001), life-threatening/major bleeding complications (BC) 5.7% (NGD 3.5%, EGD 12.4%; p = 0.015), and major vascular complications (MVC) of 3.9% (NGD 3.0%, EGD 6.2%; p = 0.041). All coefficients in the multivariate meta-regression adjusting simultaneously for the proportion of diabetes mellitus, chronic obstructive pulmonary disease, peripheral arterial disease, concomitant moderate or higher mitral regurgitation, and mean left ventricular ejection fraction (with significant coefficients in the univariate meta-regression) were not statistically significant. CONCLUSIONS: Thirty (30)-day all-cause mortality after TAVI for AR was high (9.5%) with a high incidence of moderate or higher PAR (7.4%). Compared with EGD, NGD was associated with significantly higher device success rates and significantly lower rates of second-valve deployment, moderate or higher PAR, 30-day/mid-term all-cause mortality, serious BC, and MVC.

Trends in the Incidence of In-Hospital Mortality, Cardiogenic Shock, and Utilization of Mechanical Circulatory Support Devices in Myocarditis (Analysis of National Inpatient Sample Data, 2005-2014).

BACKGROUND: Myocarditis may be associated with hemodynamic instability and portends a poor prognosis when associated with cardiogenic shock (CS). There are limited data available on the incidence of in-hospital mortality, CS, and utilization of mechanical circulatory support (MCS) devices in these patients. METHODS: We queried the 2005-2014 National Inpatient Sample databases to identify all patients aged >18 years with myocarditis in the United States. RESULTS: The number of reported cases of myocarditis per 1 million gradually increased from 95 in 2005 to 144 in 2014 (Pfor trend <.01). The trend and incidence of endomyocardial biopsy remained the same despite the increase in clinical diagnosis. Overall, in-hospital mortality was 4.43% of total admissions without a change in overall trend over the study period. We also observed a significant increase in the incidence of CS from 6.94% in 2005 to 11.99% in 2014 (Pfor trend <.01). There was a parallel increase in the utilization of advanced MCS devices during the same time period such as extracorporeal membrane oxygenation or percutaneous cardiopulmonary support (0.32% in 2005 to 2.1% in 2014; P< .01) and percutaneous ventricular assist devices such as Impella/tandem heart (0.176% in 2005 to 1.75% in 2014; P< .01). CONCLUSION: Although the incidence of myocarditis has increased in the last decade, the in-hospital mortality has remained the same despite increases in the incidence of CS, possibly reflecting the benefits of increased usage of advanced MCS devices. We noted that increasing age, presence of multiple comorbidities and CS were associated with an increase in in-patient mortality.

Impact of concurrent tricuspid regurgitation on mortality after transcatheter aortic-valve implantation.

OBJECTIVES: To determine whether concomitant tricuspid regurgitation (TR) is associated with increased mortality in patients with severe aortic stenosis (AS) undergoing transcatheter aortic-valve implantation (TAVI), we performed a meta-analysis of currently available studies. METHODS: MEDLINE and EMBASE were searched through May 2018. We included comparative or cohort studies enrolling patients with AS undergoing TAVI and reporting early (in-hospital or 30-day) and late (including early) all-cause mortality in patients stratified by baseline TR grade. An odds ratio (OR) of early mortality and a hazard ratio (HR) of late mortality with its 95% CI for significant versus non-significant (typically, ≥moderate versus

Transradial versus transfemoral percutaneous coronary intervention of left main disease: A systematic review and meta-analysis of observational studies.

OBJECTIVES: To assess the efficacy and safety of transradial (TR) versus transfemoral (TF) percutaneous coronary intervention (PCI) in left main (LM) lesion. BACKGROUND: TR-PCI is the preferred approach compared with TF approach because of less bleeding risk. LM-PCI is often challenging because of the anatomical complexity and uniqueness of supplying a large myocardium territory. We performed a systematic review and meta-analysis to assess the safety and efficacy of TR-PCI compared with TF-PCI of the LM lesions. METHODS: A comprehensive literature search of PUBMED, EMBASE, and Cochrane database was conducted to identify studies that reported the comparable outcomes between both approaches. Odds ratio (OR) and 95% confidence interval (CI) was calculated using the Mantel-Haenszel method. RESULTS: A total of eight studies were included in the quantitative meta-analysis. TR-PCI resulted in lower bleeding risk (OR 0.31, 95%CI 0.18-0.52, P < 0.01, I2 = 0%) while maintaining similar procedural success rate, target lesion revascularization, myocardial infarction, stent thrombosis, and all-cause mortality during the study follow-up period. CONCLUSIONS: TR-PCI may achieve similar efficacy with decreased bleeding risk compared to TF-PCI in LM lesions. When operator experience and anatomical complexity are favorable, TR approach is an attractive alternative access over TF approach in LM-PCI.

In-hospital outcomes of transcatheter versus surgical aortic valve replacement in non-teaching hospitals.

OBJECTIVES: To assess the in-hospital outcomes of transcatheter aortic valve replacement (TAVR) vs. surgical aortic valve replacement (SAVR) in non-teaching hospitals. BACKGROUND: TAVR has become widely available in the United States. However, the comparative outcomes of TAVR vs. SAVR in non-teaching hospitals are largely under explored. METHODS: We queried the Nationwide Inpatient Sample database from 2011 to September 2015 to identify those who were 50 years or above and underwent either trans-arterial TAVR or SAVR at non-teaching hospital. In-hospital clinical outcomes were compared with odds ratio (OR) in propensity-matched cohorts. RESULTS: We identified un-weighted 957 and 7,465 SAVR admissions. In propensity-matched model, 596 admissions in each arm were included for final analysis. In-patient mortality (3.9 vs. 2.5%, OR 1.54, P = 0.34), acute kidney injury requiring dialysis (2.2 vs. 2.7%, OR 0.80, P = 0.57), stroke (2.0 vs. 3.2%, OR 0.61, P = 0.20), and pacemaker placement (8.9 vs. 6.4%, OR 1.47, P = 0.09) was similar between TAVR and SAVR. Sub-group analysis showed that female and those with prior coronary artery bypass surgery had higher risk of in-patient morality in TAVR admission. Cost was higher (59,103 vs. 53,411 dollars, P = 0.006) but length of stay was shorter in TAVR (6.9 vs. 10.2 days, P < 0.001). CONCLUSIONS: TAVR conferred similar in-hospital mortality and major peri-procedural complications compared with SAVR in non-teaching hospitals. For those with limited access to teaching hospitals, non-teaching hospitals appear to be a reasonable option for candidates of aortic valve replacement for severe aortic stenosis.

Association of peripheral artery disease with in-hospital outcomes after endovascular transcatheter aortic valve replacement.

OBJECTIVES: The aim of this study was to determine the prevalence of peripheral artery disease (PAD) and its association with in-hospital outcomes after endovascular transcatheter aortic valve replacement (EV-TAVR). BACKGROUND: TAVR is an established treatment for patients at prohibitive, high, or intermediate surgical risk. PAD is a significant comorbidity in the determination of surgical risk. However, data on association of PAD with outcomes after EV-TAVR are limited. METHODS: Patients in the National Inpatient Sample who underwent EV-TAVR between January 1, 2012 and September 30, 2015 were evaluated. The primary outcome was in-hospital mortality. RESULTS: A total of 51,685 patients underwent EV-TAVR during the study period. Of these, 12,740 (24.6%) had a coexisting diagnosis of PAD. The adjusted odds for in-hospital mortality [OR 1.08 (95% CI 0.83-1.41)], permanent pacemaker implantation [OR 0.98 (0.85-1.14)], conversion to open aortic valve replacement [OR 1.05 (0.49-2.26)], or acute myocardial infarction [OR 1.31(0.99-1.71)] were not different in patients with versus without PAD. However, patients with PAD had greater adjusted odds of vascular complications [OR 1.80 (1.50-2.16)], major bleeding [OR 1.20 (1.09-1.34)], acute kidney injury (AKI) [OR 1.19 (1.05-1.36)], cardiac complications [aOR 1.21 (1.01-1.44)], and stroke [OR 1.39(1.10-1.75)] compared with patients without PAD. Length of stay (LOS) was significantly longer for patients with PAD [7.23 (0.14) days vs. 7.11 (0.1) days, p < 0.001]. CONCLUSION: Of patients undergoing EV-TAVR, ~25% have coexisting PAD. PAD was not associated with increased risk of in-hospital mortality but was associated with higher risk of vascular complications, major bleeding, AKI, stroke, cardiac complications, and longer LOS.