Association of Hospital Procedural Volume With Outcomes of Left Ventricular Assist Device Placement.

BACKGROUND: With the advancement in device technology, the use of durable left ventricular assist devices (LVADs) has increased significantly in recent years. However, there is a dearth of evidence to conclude whether patients who undergo LVAD implantation at high-volume centers have better clinical outcomes than those receiving care at low- or medium-volume centers. METHODS: We analyzed the hospitalizations using the Nationwide Readmission Database for the year 2019 for new LVAD implantation. Baseline comorbidities and hospital characteristics were compared among low- (1-5 procedures/year), medium- (6-16 procedures/year) and high-volume (17-72 procedures/year) hospitals. The volume/outcome relationship was analyzed using the annualized hospital volume as a categorical variable (tertiles) as well as a continuous variable. Multilevel mixed-effect logistic regression and negative binomial regression models were used to determine the association of hospital volume and outcomes, with tertile 1 (low-volume hospitals) as the reference category. RESULTS: A total of 1533 new LVAD procedures were included in the analysis. The inpatient mortality rate was lower in the high-volume centers compared with the low-volume centers (9.04% vs 18.49%, aOR 0.41, CI0.21-0.80; P = 0.009). There was a trend toward lower mortality rates in medium-volume centers compared with low-volume centers; however, it did not reach statistical significance (13.27% vs 18.49%, aOR 0.57, CI0.27-1.23; P = 0.153). Similar results were seen for major adverse events (composite of stroke/transient ischemic attack and in-hospital mortality). There was no significant difference in bleeding/transfusion, acute kidney injury, vascular complications, pericardial effusion/hemopericardium/tamponade, length of stay, cost, or 30-day readmission rates between medium- and high-volume centers compared to low-volume centers. CONCLUSION: Our findings indicate lower inpatient mortality rates in high-volume LVAD implantation centers and a trend toward lower mortality rates in medium-volume LVAD implantation centers compared to lower-volume centers.

Endovascular Transcatheter Aortic Valve Replacement Outcomes in Hypertrophic Cardiomyopathy: Insights from the National Inpatient Sample (2014-2018).

BACKGROUND: Outcomes of patients with hypertrophic cardiomyopathy (HCM) following transcatheter aortic valve replacement (TAVR) remain largely unknown. OBJECTIVES: This study sought to assess the clinical characteristics and outcomes of HCM patients following TAVR. METHODS: We queried the National Inpatient Sample from 2014 to 2018 for TAVR hospitalizations with and without HCM, creating a propensity-matched cohort to compare outcomes. RESULTS: 207,880 patients that underwent TAVR during the study period, 810 (0.38%) had coexisting HCM. In the unmatched population, TAVR patients with HCM compared to those without HCM, were more likely to be female, had a higher prevalence of heart failure, obesity, cancer, and history of pacemaker/implantable cardioverter defibrillation, and were more likely to have nonelective and weekend admissions (p for all <0.05). TAVR patients without HCM had higher prevalence of coronary artery disease, prior percutaneous coronary intervention, prior coronary artery bypass grafting, and peripheral arterial disease compared to their counterparts (p for all <0.05). In the propensity-matched cohort, TAVR patients with HCM had significantly higher incidence of in-hospital mortality, acute kidney injury/hemodialysis, bleeding complications, vascular complications, permanent pacemaker requirement, aortic dissection, cardiogenic shock, and mechanical ventilation requirement. CONCLUSION: Endovascular TAVR in HCM patients is associated with an increased incidence of in-hospital mortality and procedural complications.

Association of hospital procedural volume with incidence and outcomes of surgical bailout in patients undergoing transcatheter aortic valve replacement.

OBJECTIVES: This study sought to examine the association of hospital procedural volume with the incidence and outcomes of surgical bailout (SB) in patients who undergo transcatheter aortic valve replacement (TAVR). BACKGROUND: SB is required for serious complications during or after TAVR. It remains unclear whether hospital experiences affect the incidence and outcomes of SB. METHODS: We retrospectively identified patients who underwent endovascular TAVR using the Nationwide Readmissions Database 2012-2017. We examined the association of annual hospital procedural volume (annual number of endovascular TAVR cases in each hospital in each year) with the incidence and in-hospital mortality of SB using multivariable logistic regressions and restricted cubic splines. RESULTS: Among 82,764 eligible patients, the incidence of SB was 0.95% (n = 789) and decreased from 2012 to 2017 (from 2.66% to 0.49%; Ptrend < 0.001), while in-hospital mortality of SB remained high over years (from 26.0% to 23.5%; Ptrend  = 0.773). Very-high-volume hospitals (≥200 cases/year), as compared with low-volume hospitals (≤49 cases/year), showed significantly a lower incidence of SB (0.49% vs. 1.81%; adjusted OR = 0.28, 95% CI = 0.21-0.38), but similar in-hospital mortality of SB (26.2% vs. 25.6%; adjusted OR = 0.88, 95% CI = 0.47-1.66). There was a significant nonlinear, inverse association of hospital volume with the incidence of SB, but not with the in-hospital mortality of SB. CONCLUSIONS: Hospitals with higher TAVR volumes have a lower risk of SB, but the in-hospital mortality after SB does not change with hospital TAVR volume. Our findings highlight the importance that physicians should always be aware of the high mortality risk of SB following TAVR regardless of hospital procedural experiences.

Incidence, treatment, and outcomes of acute myocardial infarction following transcatheter or surgical aortic valve replacement.

OBJECTIVES: This study aimed to evaluate the incidence, treatment, and outcomes of acute myocardial infarction (AMI) following transcatheter or surgical aortic valve replacement (TAVR or SAVR). BACKGROUND: Coronary artery disease is common in patients who undergo aortic valve replacement. However, little is known about differences in clinical features of post-TAVR or post-SAVR AMI. METHODS: We retrospectively identified post-TAVR or post-SAVR (including isolated and complex SAVR) patients admitted with AMI using the Nationwide Readmissions Database 2012-2017. Incidence, invasive strategy (coronary angiography or revascularization), and in-hospital outcomes were compared between post-TAVR and post-SAVR AMIs. RESULTS: The incidence of 180-day AMI was higher post-TAVR than post-SAVR (1.59% vs. 0.72%; p < 0.001). Post-TAVR AMI patients (n = 1315), compared with post-SAVR AMI patients (n = 1344), were older, had more comorbidities and more frequent non-ST-elevation AMI (NSTEMI: 86.6% vs. 78.0%; p < 0.001). After propensity-score matching, there was no significant difference in in-hospital mortality between post-TAVR and post-SAVR AMIs (14.7% vs. 16.1%; p = 0.531), but the mortality was high in both groups, particularly in ST-elevation AMI (STEMI: 38.8% vs. 29.2%; p = 0.153). Invasive strategy was used less frequently for post-TAVR AMI than post-SAVR AMI (25.6% vs. 38.3%; p < 0.001). Invasive strategy was associated with lower mortality in both post-TAVR (adjusted odds ratio = 0.40; 95% confidence interval = [0.24-0.66]) and post-SAVR groups (0.60 [0.41-0.88]). CONCLUSIONS: AMI, albeit uncommon, was more frequent post-TAVR than post-SAVR. Patients commonly presented with NSTEMI, but the mortality of STEMI was markedly high. Further studies are needed to understand why a substantial percentage of patients do not receive invasive coronary treatment, particularly after TAVR, despite seemingly better outcomes with invasive strategy.

Radiation reduction in a modern catheterization laboratory: A single-center experience.

BACKGROUND: Measures were undertaken at the Cleveland Clinic to reduce radiation exposure to patients and personnel working in the catheterization laboratories. We report our experience with these improved systems over a 7-year period in patients undergoing diagnostic catheterization (DC) and percutaneous coronary interventions (PCIs). METHODS: Patients were categorized into preinitiative (2009-2012) and postinitiative (2013-2019) groups in the DC and PCI cohorts. Propensity score matching was done between the pre- and postinitiative groups for both cohorts based on age, sex, body surface area, total fluoroscopy time, and total acquisition time. The effectiveness of radiation reduction measures was assessed by comparing the total air kerma (Ka,r ), and fluoroscopy- and acquisition-mode air kerma in patients in the two groups. RESULTS: In the DC cohort, there was a significant reduction in Ka,r in the postinitiative group in comparison to the preinitiative group (median, 396 vs. 857 mGy; p < 0.001). In the PCI cohort, Ka,r in the postinitiative group was 1265 mGy, which was significantly lower than the corresponding values in the preinitiative group (1994 mGy; p < 0.001). We also observed a significant reduction in fluoroscopy- and acquisition-based air kerma rates, and air kerma area product in the postinitiative group in comparison to the preinitiative group in both matched and unmatched DC and PCI cohorts after the institution of radiation reduction measures. CONCLUSION: There was a significant and sustained reduction in radiation exposure to patients in the catheterization laboratory with the implementation of advanced protocols. Similar algorithms can be applied in other laboratories to achieve a similar reduction in radiation exposure.

Lower rates of endoscopy and higher mortality in end-stage renal disease patients with gastrointestinal bleeding: A propensity matched national study.

BACKGROUND AND AIM: Patients with end-stage renal disease (ESRD) on hemodialysis are considered to be at higher risk of gastrointestinal bleeding (GIB) as compared with those without renal disease (NRD). We conducted a population-based study using the National Inpatient Sample (NIS) database to study the outcomes of GIB in ESRD. METHODS: Patients admitted with GIB (upper and lower) from 2005 to 2013 were extracted from the NIS database using ICD-9 codes. Patients were divided into NRD and ESRD groups, and a 1:1 propensity matched analysis was performed. Various outcomes were compared in both groups, and subgroup analysis based on the timing of endoscopy was also performed. RESULTS: A total of 218 032 patients were included in the study. There was an increase in inpatient admissions among ESRD patients with GIB with significant reduction in mortality (P < 0.001). In-hospital mortality, length of stay, and total costs were significantly higher in ESRD patients as compared with NRD. ESRD patients were less likely to undergo endoscopic evaluation compared with NRD (P < 0.001). Late endoscopy (> 48 h) was associated with increased need for transfusion and health-care utilization but without a significant difference in mortality as compared with early endoscopy. On multivariate analysis, endoscopy was associated with significantly lower rate of mortality in ESRD patients with GIB (odds ratio 0.28, P < 0.0001). CONCLUSION: End-stage renal disease patients with GIB had a significantly higher rate of mortality and a higher health-care utilization with a lower rate of endoscopic evaluation. Endoscopy was associated with a lower mortality rate on multivariate analysis.

Association of acute kidney injury with outcomes in patients undergoing percutaneous left atrial appendage closure.

OBJECTIVES: Using a large nationally representative database, we aimed to examine risk factors for acute kidney injury (AKI) and its association with outcomes in patients undergoing percutaneous left atrial appendage closure (LAAC). BACKGROUND: Previous small-scale studies have reported poor outcomes with AKI following percutaneous LAAC. METHODS: We queried the Nationwide Readmission Database to identify LAAC procedures performed from 2016 to 2017. Multivariable logistic and linear regression models were used to identify risk factors for AKI and determine the association between AKI and clinical outcomes. The primary outcome of interest was in-hospital mortality. RESULTS: Of 20,703 patients who underwent LAAC during the study period, 1,097 (5.3%) had a diagnosis of AKI. Chronic kidney disease, non-elective admission, coagulopathy, weight loss, prior coronary artery disease, heart failure, diabetes mellitus, and anemia were independently associated with an increased risk of AKI after LACC. In patients undergoing LAAC, AKI was associated with an increased risk of in-hospital mortality (adjusted odds ratio [aOR], 16.01; 95% CI, 8.48-30.21), stroke/transient ischemic attack (aOR, 2.50; 95% CI, 1.69-3.70), systemic embolization (aOR, 3.78; 95% CI, 1.64-8.70), bleeding/transfusion (aOR, 1.96; 95% CI, 1.50-2.56), vascular complications (aOR, 3.53; 95% CI, 1.94-6.42), pericardial tamponade requiring intervention (aOR, 6.83; 95% CI, 4.37-10.66), index length of stay (adjusted parameter estimate, 7.46; 95% CI, 7.02-7.92), and 180-day all-cause readmissions (aOR, 1.43; 95% CI, 1.09-1.88). CONCLUSION: AKI in the setting of LAAC is uncommon but is associated with poor clinical outcomes. Further studies are needed to determine if a similar association exists for long-term outcomes.

A meta-analysis of efficacy and safety of genotype-guided versus standard of care treatment strategies in selecting antiplatelet therapy in patients with acute coronary syndrome.

BACKGROUND: Previous studies have shown similar rates of major adverse cardiovascular events (MACE) in acute coronary syndrome (ACS) patients, treated with P2Y12 inhibitors based on genotype guidance compared to standard treatment. However, given lower than expected event rates, these studies were underpowered to assess hard outcomes. We sought to systematically analyze this evidence using pooled data from multiple studies. METHODS: Electronic databases were searched for studies of ACS patients that underwent genotype-guided treatment (GGT) with P2Y12 inhibitors versus standard of care treatment (SCT). Studies with a minimum follow-up of 12 months were included. Rate of MACE (defined as a composite of cardiovascular [CV] mortality, nonfatal myocardial infarction [MI], and nonfatal stroke) was the primary outcome. Secondary outcomes were individual components of MI, CV mortality, ischemic stroke, stent thrombosis, and major bleeding. Odds ratios (ORs) and corresponding 95% confidence intervals (CIs) were calculated and combined using random effects model meta-analysis. RESULTS: A total of 4,095 patients (2007 in the GGT and 2088 in the SCT group were analyzed from three studies). Significantly lower odds of MACE (6.0 vs. 9.2%; OR: 0.63, 95% CI: 0.50-0.80, p < .001, I2 = 0%) and MI (3.3 vs. 5.45%; OR: 0.63; CI 0.41-0.96; p = .03; I2 = 46%) were noted in the GGT group compared to SCT. No significant difference was noted with respect to CV and other secondary outcomes. CONCLUSION: In patients with ACS, genotype-guided initiation of P2Y12 inhibitors was associated with lower odds of MACE and similar bleeding risk in comparison to SCT.

Short-term outcomes of transcatheter aortic valve replacement for pure native aortic regurgitation in the United States.

OBJECTIVE: We aimed to compare short-term outcomes between transcatheter aortic valve replacement (TAVR) for pure aortic regurgitation (AR) and TAVR for aortic stenosis (AS). BACKGROUND: In patients with severe pure AR for whom surgical valve replacement is infeasible, TAVR is sometimes used off-label. METHODS: Using the Nationwide Readmissions Database 2016-2017, we retrospectively identified patients without prior valve surgery who underwent endovascular TAVR. We compared in-hospital and 30-day outcomes according to the type of aortic valve disease. RESULTS: A total of 81,542 eligible patients were divided into the pure AR (n = 1,222, 1.50%), pure AS (n = 72,690, 89.1%), and AS + AR (n = 7,630, 9.36%) groups. In unadjusted analyses, the pure AR group, compared with the pure AS and AS + AR groups, showed a higher incidence of acute kidney injury (16.8% vs. 9.8% vs. 12.1%, respectively; p < .001) and need of surgical bailout (1.4% vs. 0.4% vs. 0.6%; p < .01). The pure AR group also showed higher in-hospital mortality than the pure AS group (2.4% vs. 1.4%; p = .005). After multivariable adjustment, TAVR for pure AR was significantly associated with a higher risk of acute kidney injury (odds ratio [OR] = 1.64, 95% confidence interval [CI] = 1.33-2.02; p < .001), cardiac tamponade (OR = 1.98, 95% CI = 1.00-3.92; p = .0498), and prolonged hospital stay (OR = 1.59, 95% CI = 1.29-1.95; p < .001) compared with TAVR for pure AS, whereas it was not significantly associated with in-hospital mortality (OR = 1.55, 95% CI = 0.99-2.45; p = .058) and other outcomes. CONCLUSIONS: TAVR may be a reasonable treatment option for selected patients with pure AR with regard to short-term outcomes. However, additional techniques or devices may be necessary to reduce periprocedural risk.

Utilization and outcomes of transcatheter coil embolization for various coronary artery lesions: Single-center 12-year experience.

OBJECTIVE: Determining the outcomes of transcatheter coil embolization (TCE) for several coronary artery lesions. BACKGROUND: TCE has been used as a treatment modality for various lesions in the coronary circulation. However, data on the efficacy and safety of TCE to treat coronary artery fistula (CAF), left internal mammary artery (LIMA) side-branch, coronary artery perforation (CAP), coronary artery aneurysm (CAA), and coronary artery pseudoaneurysm (CAPA) are limited. METHODS: We conducted a retrospective, descriptive analysis of all TCE devices in coronary lesions at our center from 2007 to 2019. Forty-one studied lesions included 25 CAF, 7 LIMA side-branch, 5 CAP, 2 CAA, and 2 CAPA. Short- and 1-year mortality and hospital readmission were reported, in addition to coil-related complications and procedural success. RESULTS: The utilization rate of TCE in coronary artery lesions at our center was found to be 33.8 per 100,000 percutaneous coronary intervention procedures over 12 years. Successful angiographic closure was achieved in 37 out of 41 (87.8%) cases (88, 100, 60, 100, and 100% of CAF, LIMA side-branch, CAP, CAA, and CAPA, respectively). No adverse events were directly related to TCE among the LIMA, CAA, and CAPA cases, and only one patient with CAF required reintervention at 3 months due to coil migration. CONCLUSIONS: Coil embolization in our institution was safe and effective in treating different coronary circulation abnormalities with a 87.8% overall success rate. Further study on the use of vascular plug devices in cases such as CAF or LIMA side-branch would be beneficial to understand the treatment options better.

Impact of atrial fibrillation on outcomes following MitraClip: A contemporary population-based analysis.

OBJECTIVES: Despite the rising use of MC, the impact of preexisting AF, a common comorbidity, on short-term postprocedural outcomes is poorly defined. We sought to assess outcomes between patients with and without atrial fibrillation (AF) who underwent percutaneous mitral valve repair with MitraClip (MC). METHODS: In this retrospective cohort study, the Nationwide Readmissions Database was queried for patients who underwent MC between 2014-2017. Groups were stratified based on the presence of AF. Multivariable logistic regression analyses were performed to identify the association between AF and in-hospital stroke and mortality. RESULTS: Of the 15,570 patients who underwent MC, 7,740 (49.7%) had AF. AF patients were older (82 vs. 79 years, p < .001) and more comorbid. Patients with AF relative to without AF demonstrated increased rates of in-hospital ischemic (1.3% vs .0.7%, p < .001) and hemorrhagic stroke (0.3% vs. 0.1%, p = .007), longer duration of hospitalization (median 3 vs. 2 days, p < .001), and similar in-hospital mortality (2.8% vs. 2.6%, p = .52). After adjusting for comorbidities, age, sex, hospital procedural volume, and CHA2DS2-VASc, the presence of AF was associated with higher in-hospital stroke (OR = 2.096, 95%CI[1.503-2.921], p < .001) but not in-hospital mortality (OR = 1.012, 95%CI[0.828-1.238], p = .904). AF patients were more likely to be readmitted (16.8% vs.14.1%, p < .001) and die (1.5% vs. 0.9%, p = .005) within 30 days of discharge despite similar incidences of stroke (0.7% vs. 0.6%, p = .53). CONCLUSIONS: The increased risk of in-hospital stroke, 30-day mortality, and longer hospitalization suggest the need for increased preprocedural optimization by means of stroke prevention strategies in those with AF undergoing MC.

Association of baseline kidney disease with outcomes of transcatheter mitral valve repair by MitraClip.

OBJECTIVES: This study sought to determine the impact of baseline chronic kidney disease (CKD) on in-hospital outcomes of transcatheter mitral valve repair with MitraClip (MC). BACKGROUND: MC is now an established treatment in high surgical risk patients. However, limited data are available on outcomes of MC in patients with baseline renal dysfunction. METHODS: The authors used data from January 2014 to December 2017 National Readmission Database to identify all patients ≥18 years of age who underwent MC. International classification of diseases (ICD)-9 and ICD-10 codes were used to identify patients with no-CKD, CKD (without chronic dialysis), or end-stage renal disease (ESRD) on dialysis. Multivariable logistic regression models were constructed using generalized estimating equations to examine in-hospital outcomes. RESULTS: Of 13,563 patients undergoing MC, 8,935 (65.8%) had no-CKD, 4,152 (30.6%) had CKD, and 476 (3.5%) had ESRD. ESRD patients compared to CKD and no-CKD had significantly higher mortality (7.2% vs. 2.5% vs. 2.0%; p < .001), higher incidence of bleeding, blood transfusions, and 30 day all cause readmission. CKD patients compared to no-CKD had significantly higher mortality (odds ratio-1.29; CI 1.01-1.65; p = .04), acute kidney injury (odds ratio-3.0; CI 2.69-3.34; p < .001), new in-hospital hemodialysis (odds ratio- 2.70; CI 1.57-4.62; p < .001), blood transfusions, 30 day all cause and congestive heart failure (CHF) readmissions. In-hospital stroke and cardiac tamponade did not differ between the three groups. Patients with baseline kidney disease undergoing MC had higher mortality at high volume centers compared to low volume centers. CHF was the most common cause of readmission postMC in patients with or without preprocedural kidney disease. CONCLUSION: Patients with baseline kidney disease have worse outcomes after MC with higher readmission rates requiring careful patient selection and follow up in this population.

Impact of thoracic aortic aneurysm on outcomes of transcatheter aortic valve replacement: A nationwide cohort analysis.

BACKGROUND: The use of transcatheter aortic valve replacement (TAVR) has expanded to patient populations of varying surgical risk in light of recent clinical trials, yet its role in patients with aortic stenosis and coexisting thoracic aortic aneurysm (TAA) is not well-delineated. We aimed to evaluate whether risk factors and in-hospital outcomes vary between TAVR patients with and without an unruptured TAA. METHODS: The Nationwide Readmissions Database was queried for patients hospitalized between January 2012 and December 2017 who underwent TAVR with and without an unruptured TAA. In-hospital outcomes were compared between cohorts after adjusting for sex, comorbidities, and TAVR approach, and in a subgroup analysis that excluded those with bicuspid aortic valves. RESULTS: Among 171,011 TAVR patients, 1,677 (1%) presented with TAA. Patients with TAA were younger (median age 80 vs. 82 years, p < .001) and more likely to have bicuspid aortic valves (9.3% vs. 0.9%, p < .001). Among patients with aneurysm, 2.6% died, 2.2% developed stroke, 1% developed aortic dissection, and 1.4% experienced cardiac tamponade while hospitalized. After adjusting for age, sex, bicuspid aortic valve, and all comorbidities, TAA was associated with significantly higher risk of post-TAVR aortic dissection (OR = 2.117, 95% CI [1.304-3.435], p = .002) and cardiac tamponade (OR = 1.682, 95% CI [1.1-2.572], p = .02). CONCLUSIONS: While the overall incidence of post-TAVR complications is low, patients with an unruptured TAA should be carefully considered by the Heart Team in weighing the additional risks of aortic dissection and cardiac tamponade after TAVR with those associated with surgery.

Incidence and short-term outcomes of surgical bailout after transcatheter mitral valve repair with the MitraClip system.

OBJECTIVES: This study sought to investigate the incidence and outcomes of surgical bailout (SB) after transcatheter mitral valve repair (TMVr) with MitraClip. BACKGROUND: TMVr poses a risk of serious procedural complications, possibly requiring urgent open surgery for SB. However, little is known about the risk of SB cases after TMVr. METHODS: We retrospectively identified patients who underwent TMVr using the Nationwide Readmissions Database 2014-2017. SB was defined as open thoracotomy for heart and aorta during the same hospitalization. Annual hospital volume was defined as the annual number of TMVr cases in each hospital in each year. RESULTS: Among 15,032 eligible patients, SB was required in 214 (1.42%), of whom 134 (62.6%) underwent mitral valve surgery (113 replacements; 21 repairs). The incidence of SB was decreasing significantly over the 4 years (5.26% in 2014; 0.43% in 2017; ptrend < .001). There was a significant nonlinear, inverse association of annual hospital volume with the incidence of SB. In-hospital death (15.0 vs. 2.1%; p < .001) and other in-hospital adverse events were significantly more frequent in patients with than without SB, whereas the 30-day readmission rate was similar (13.2 vs. 15.1%; p = .572). After adjustment for patient and hospital characteristics, SB was significantly associated with higher in-hospital mortality (odds ratio = 6.67, 95% confidence interval = 4.35, 10.23, p < .001). CONCLUSIONS: This study suggests that although the incidence of SB after TMVr is decreasing, SB is required more frequently in lower-volume hospitals and carries high in-hospital mortality. Further efforts are needed to understand the reasons for SB and improve outcomes in patients needing SB.

Association of Acute Kidney Injury with Outcomes in Patients Undergoing Transcatheter Mitral Valve Repair.

INTRODUCTION: Although transcatheter mitral valve repair (TMVr) is a contrast-free procedure, prior single-center studies have demonstrated a high incidence of acute kidney injury (AKI) following TMVr. The main objective of this study was to examine risk factors for AKI, and its association with outcomes in patients undergoing TMVr. METHODS: We queried the National Readmission Database to identify TMVr procedures performed between January 2014 and December 2017. Complex samples multivariable logistic and linear regression models were used to identify risk factors associated with AKI, as well as to determine the association between AKI and clinical outcomes (in-hospital mortality, index length of stay (LOS), 30-day all-cause readmissions, and 30-day heart failure [HF] readmissions). RESULTS: Of 14,623 patients who underwent TMVr during the study period, 2,001 (13.6%) had a diagnosis of AKI. HF, chronic kidney disease, chronic liver disease, fluid/electrolyte disorder, weight loss, nonelective admission, cardiogenic shock, and bleeding/transfusion were independently associated with an increased risk of AKI. In patients undergoing TMVr, AKI was associated with an increased risk of in-hospital mortality (adjusted odds ratio [aOR], 4.94; 95% confidence interval [CI], 2.92-8.34), 30-day all-cause readmissions (aOR, 1.91; 95% CI, 1.49-2.46), 30-day HF readmissions (aOR, 2.30; 95% CI, 1.38-3.84), and longer index LOS (adjusted parameter estimate, 5.78; 95% CI, 5.26-6.41). CONCLUSION: AKI in the setting of TMVr is common and is associated with worse clinical outcomes. Further studies are needed to determine if optimizing renal function prior to TMVr may improve outcomes, as well as to understand the impact of TMVr itself on renal function.

Left main percutaneous coronary intervention-Radial versus femoral access: A systematic analysis.

BACKGROUND: Debate still occurs of the benefits of transradial access (TRA) versus transfemoral access (TFA), especially for complex percutaneous coronary interventions. Recent data has shown equivalent efficacy and improved safety outcomes with TRA. OBJECTIVES: To systematically review and perform a meta-analysis comparing procedural characteristics and clinical outcomes of TRA versus TFA in patients who underwent percutaneous coronary intervention (PCI) for left main (LM) disease. METHODS: We conducted an electronic database search of all published data for studies that compared TRA with TFA in patients undergoing PCI of LM disease. Event rates were compared using the odds ratio (OR) as a measure of effect size. Random-effects models were used to account for interstudy heterogeneity. RESULTS: A total of 12 observational studies including 17,258 patients (TRA n = 7,971; TFA n = 9,287) were included. Compared to TFA, TRA was associated with a significant reduction in access site bleeding (OR = 0.11; 95% confidence interval [CI] = 0.04-0.26; I2 = 0%; p < .0001), major bleeding (OR = 0.44; 95% CI = 0.27-0.69; I2 = 0%; p = .0005) or any bleeding episode (OR = 0.43; 95% CI = 0.27-0.69; I2 = 12%; p = .0004). Rates of access site or vascular complications (OR = 0.26; 95% CI = 0.17-0.40; I2 = 0%; p < .00001) and in-hospital mortality (OR = 0.49; 95% CI = 0.31-0.79: I2 = 11%; p = .004) were also lower in the TRA group. There were no significant differences in procedural outcomes between TRA and TFA except for a significant reduction in the rate of long-term target vessel revascularization (TVR) in the TRA group (OR = 0.62; 95% CI = 0.41-0.94: I2 = 0%: p = .02). We further performed a subgroup analysis for unprotected left main PCI only, which showed a significant reduction in rates of any bleeding episode, lower access site or vascular complications, and in-hospital mortality with TRA as compared to TFA. CONCLUSION: Patients undergoing PCI for LM disease via TRA have with less bleeding, reduced access site or vascular complications, reduced in-hospital mortality, comparable procedural success, and possibly better long-term clinical efficacy when compared to those undergoing the procedure via TFA.

Incidence, outcomes, and predictors of in-hospital acute coronary syndrome following endovascular transcatheter aortic valve replacement in the United States.

BACKGROUND: Incidence and outcomes of acute coronary syndrome (ACS) immediately following transcatheter aortic valve replacement (TAVR) remain largely unknown. OBJECTIVES: This study sought to assess the incidence, clinical characteristics, and outcomes of ACS following TAVR. METHODS: We queried the National Readmission Database from January 2012 to September 2015 for TAVR admissions with and without ACS, creating a propensity-matched cohort to compare outcomes. RESULTS: A total of 48,454 patients underwent TAVR, with 1,332 (2.75%) developing ACS. TAVR patients with ACS compared to those without ACS had a significantly higher incidence of acute kidney injury (24.7 vs. 19.2%; p = .001), ischemic stroke (3.7 vs. 2.3%; p = .04), vascular complications (8.6 vs. 5.8%; p = .008), cardiogenic shock (9.8 vs. 1.9%; p < .001), cardiac arrest (5.1 vs. 2.8%; p = .002), mechanical circulatory support (8.1 vs. 1.5%; p < .001), and in-hospital mortality (9.6 vs. 3.4%; p < .001). Additionally, TAVR with ACS had longer lengths of stay (median 10 days vs. 6 days; p < .001) and hospital charges (median $23,200 vs. $19,000; p < .001). Positive predictors of ACS were history of PCI (odds ratio, 1.43; 95% CI: 1.25-1.63), hyperlipidemia (odds ratio, 1.20; 95% CI: 1.07-1.34), chronic blood loss anemia (odds ratio, 2.16; 95% CI: 1.54-3.03), chronic kidney disease (odds ratio, 1.17; 95% CI: 1.04-1.31), fluid and electrolyte disorders (odds ratio, 1.65; 95% CI: 1.47-1.85), and weight loss (odds ratio, 1.53; 95% CI: 1.22-1.91). Heart failure (34%) was the most common reason for readmission in the ACS cohort. CONCLUSION: ACS after TAVR is uncommon but is associated with worse clinical outcomes and increased healthcare resource utilization.

The utilization of single versus double Perclose devices for transfemoral aortic valve replacement access site closure: Insights from Cleveland Clinic Aortic Valve Center.

INTRODUCTION: Percutaneous femoral access is the preferred access route for transcatheter aortic valve replacement (TAVR). The majority of experienced TAVR centers use two 6F Perclose ProGlide™ devices to close the primary vascular access site, deployed prior to upsizing sheath size with closure completed at the end of the case (the "preclose" approach). A strategy of utilizing a single Perclose device to preclose may have advantages including fewer complications, complexity, and cost, but the safety of this is unknown. This study examines in the safety and efficacy of using a single Perclose versus double Perclose for perclosure of large bore access during TAVR. METHODS: Patients undergoing Transfemoral (TF) TAVR from January 2014 to December 2017 within the Cleveland Clinic Aortic Valve Center were identified. A retrospective review of medical charts was conducted. Vascular complications were defined according to the VARC-2 criteria. RESULTS: A total of 740 patients were included; 487 (65.8%) received a single Perclose device while 253 (34.2%) received double Perclose devices. Baseline characteristics were similar with no differences between the single versus double Perclose groups, respectively. The access sheath size was similar in both groups with (14, 16, and 18 F) being the most common sizes utilized. Of the total 487 patients with single Perclose, 75.6% needed additional closure device (AngioSeal). With double Perclose strategy, additional closure device (AngioSeal) was used in 40.3% patients with 470 (63.5%) patients being successfully perclosed. Vascular complication rates including hematoma, stenosis requiring stenting, pseudoaneurysm, and other major vascular complications were similar between both groups. CONCLUSION: Single 6F ProGlide use for preclosure is a safe strategy for TF TAVR using the S3 valve. Additional closure device was not needed in almost one-quarter of the patients. When necessary, residual bleeding can be controlled with the AngioSeal Device at the end of the procedure. This single device preclose strategy can help to reduce the cost of TAVR procedure without increasing risk.

Risks, time trends, and mortality of colonoscopy-induced perforation in hospitalized patients.

BACKGROUND AND AIM: Colonic perforation is a rare complication of colonoscopy and ranges from 0% to 1% in all patients undergoing colonoscopy. The aim of this study was to assess the time trends, risk factors, and mortality associated with colonoscopy-induced perforation (CIP) in hospitalized patients as the data are limited. METHODS: Data are obtained from the Nationwide Inpatient Sample database to identify hospitalized patients between 2005 and 2014 that had CIP. Various factors like age and gender were assessed for association with CIP, followed by univariate and multivariate regression analyses. RESULTS: A total of 2 651 109 patients underwent inpatient colonoscopy between 2005 and 2014, and 4567 (0.2%) of the patients had CIP. Overall, incidence of CIP has increased from 2005 to 2014 (0.1% to 0.3%) (P < 0.001). On multivariate analysis, the adjusted odds ratio (OR) for CIP was highest in Caucasian race (OR: 1.49 [1.09, 2.06]), followed by after polypectomy, history of inflammatory bowel disease, end-stage renal disease, and age > 65 years (OR [95% CI] of 1.35 [1.23, 1.47], 1.34 [1.17, 1.53], 1.28 [1.02, 1.62], and 1.21 [1.11, 1.33], respectively) (all P < 0.05). CIP group had 33% less obesity (OR [95% CI]: 0.77 [0.65-0.9], P = 0.002) and 13-fold higher mortality (0.5% vs 8.1%) (P < 0.001) as compared to patients without CIP. The CIP-associated mortality ranged from 2% to 8% and remained stable throughout the study period. CONCLUSIONS: Our study suggests that the risk of CIP was highest in elderly patients, Caucasians, those with inflammatory bowel disease, end-stage renal disease, and after polypectomy. Recognizing the factors associated with CIP may lead to informed discussion about risks and benefits of inpatient colonoscopy.