Supplemental calcium and vitamin D and long-term mortality in aortic stenosis.

OBJECTIVE: Calcium metabolism has long been implicated in aortic stenosis (AS). Studies assessing the long-term safety of oral calcium and/or vitamin D in AS are scarce yet imperative given the rising use among an elderly population prone to deficiency. We sought to identify the associations between supplemental calcium and vitamin D with mortality and progression of AS. METHODS: In this retrospective longitudinal study, patients aged ≥60 years with mild-moderate native AS were selected from the Cleveland Clinic Echocardiography Database from 2008 to 2016 and followed until 2018. Groups were stratified into no supplementation, supplementation with vitamin D alone and supplementation with calcium±vitamin D. The primary outcomes were mortality (all-cause, cardiovascular (CV) and non-CV) and aortic valve replacement (AVR), and the secondary outcome was AS progression by aortic valve area and peak/mean gradients. RESULTS: Of 2657 patients (mean age 74 years, 42% women) followed over a median duration of 69 months, 1292 (49%) did not supplement, 332 (12%) took vitamin D alone and 1033 (39%) supplemented with calcium±vitamin D. Calcium±vitamin D supplementation was associated with a significantly higher risk of all-cause mortality (absolute rate (AR)=43.0/1000 person-years; HR=1.31, 95% CI (1.07 to 1.62); p=0.009), CV mortality (AR=13.7/1000 person-years; HR=2.0, 95% CI (1.31 to 3.07); p=0.001) and AVR (AR=88.2/1000 person-years; HR=1.48, 95% CI (1.24 to 1.78); p<0.001). Any supplementation was not associated with longitudinal change in AS parameters in a linear mixed-effects model. CONCLUSIONS: Supplemental calcium with or without vitamin D is associated with lower survival and greater AVR in elderly patients with mild-moderate AS.

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.

Percutaneous Coronary Intervention Outcomes Based on Decision-Making Capacity.

Background Long-term outcomes of percutaneous coronary intervention (PCI) based on patients' decision-making ability have not been studied. Our objective was to assess long-term outcomes after PCI in patients who provided individual versus surrogate consent. Methods and Results Data were collected retrospectively for patients who underwent PCI at Cleveland Clinic between January 1, 2015 and December 31, 2016. Inclusion criteria consisted of hospitalized patients aged ≥20 years who had PCI. Patients with outpatient PCI, or major surgery 30 days before or 90 days after PCI, were excluded. Patients who underwent PCI with surrogate consent versus individual consent were matched using the propensity analysis. Kaplan-Meier, log rank, t-statistic, and χ2 tests were used for statistical analysis. The study was approved by the Institutional Review Board at Cleveland Clinic, Ohio. Of 3136 patients who underwent PCI during the study period, 183 had surrogate consent. Propensity matching yielded 149 patients from each group. Two-year all-cause mortality was significantly higher in the surrogate consent group (38 [25.5%] versus 16 [10.7%] deaths, log-rank χ2=10.16, P<0.001). The 2-year major adverse cardiac events rate was also significantly higher in the surrogate consent group (60 versus 36 events, log-rank χ2=8.36, P=0.003). Conclusions Patients with surrogate consent had significantly higher all-cause mortality and higher major adverse cardiac events when compared with patients with individual consent. This study emphasizes the fact that patients with an inability to give consent are at high risk and may need special attention in postprocedural and postdischarge care.

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.

Trends and outcomes of infective endocarditis in cirrhosis: a propensity-matched national study.

BACKGROUND: Cirrhosis is the most common cause of liver-related death and bacterial infection is a common comorbidity in cirrhosis. We aimed to study the trends and outcomes of infective endocarditis in cirrhosis. METHODS: A propensity-matched analysis of the National Inpatient Sample database was performed to assess outcomes of infective endocarditis in adult patients (>18 years) from 2004-2013 with and without cirrhosis. Various outcomes were assessed for outcomes of infective endocarditis in cirrhosis. Multivariate regression analysis was performed for predictors of mortality in infective endocarditis. RESULTS: There has been no significant change in incidence (3.3-3.6%, P = 0.27) and overall mortality (6.3-8.6%, P = 0.42) of infective endocarditis in cirrhosis. After propensity matching, patients with cirrhosis had significantly higher in-hospital mortality (15 vs. 10.6%, P < 0.001) and acute kidney injury (AKI) (31.8 vs. 28.5%, P < 0.001) as compared to no cirrhosis. Microbiological analysis revealed significantly higher rates of streptococci (35.3 vs. 31.9%, P < 0.001) and fungal infective endocarditis (0.03 vs. 0%, P < 0.001) and lower incidence of Gram-negative infective endocarditis (3.9 vs. 6.3%, P < 0.001) in cirrhosis. Cirrhosis patients had significantly less surgical intervention (10.2 vs. 30.3%, P < 0.001) along with overall total cost and length of stay as compared to no cirrhosis. On multivariate analysis, advanced age, AKI, shock and mechanical ventilation were positive predictors of mortality in infective endocarditis patients with cirrhosis patients. CONCLUSIONS: Cirrhosis is an independent predictor of mortality in infective endocarditis with worse outcomes and less surgical intervention. Gram-negative infective endocarditis is lower in cirrhosis, whereas streptococci and fungal infective endocarditis are higher than noncirrhotic patients.

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.

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.

Transaminases are Potential Biomarkers of Disease Severity in COVID-19 Patients: A Single-Center Experience.

BACKGROUND: Considering the rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), the clinical implications of gastrointestinal (GI) and hepatic manifestations of coronavirus disease 2019 (COVID-19) in the U.S. population require analysis. METHODS: We retrospectively reviewed all adult patients with COVID-19 admitted to our facility. Patients were divided into two groups based on the presence of GI symptoms and transaminitis at presentation. Univariable analysis was performed to assess the differences between study groups. Kruskal-Wallis and Pearson's chi-square tests were used to compare the median of continuous and categorical variables, respectively. Multivariate logistic regression analysis was performed to identify predictors of mechanical ventilation, cytokine release syndrome (CRS), and mortality after adjusting for baseline variables. RESULTS: A total of 84 patients were analyzed. After adjusting for baseline comorbidities, presence of GI symptoms (aOR, adjusted odds ratio 4.2, 95% CI, 1.17-15.60, p=0.03) and transaminitis on admission (aOR 5.69, 95% CI, 1.47-21.99, p=0.01) were associated with CRS. Transaminitis on admission and elevated total bilirubin during hospitalization were associated with an increased need for mechanical ventilation (aOR 6.17, 95% CI, 1.49-25.44, p=0.02 and aOR 7.29, 95% CI, 1.73-30.75, p=0.007, respectively). An elevated aspartate aminotransferase (AST) on admission (aOR 13.41, 95% CI, 1.08-165.69, p=0.04) and elevated total bilirubin during hospitalization (aOR 82.68, 95% CI, 1.67-4074.8, p=0.02) were independently associated with an increased risk of mortality in COVID-19 patients. CONCLUSION: COVID-19 patients with transaminitis on admission had a higher risk of requiring mechanical ventilation and developing CRS. Patients with elevated AST on admission and elevated total bilirubin had higher mortality. Patients with GI symptoms did not have worse outcomes.

Systematic review and meta-analysis of valve-in-valve transcatheter aortic valve replacement in patients with failed bioprosthetic aortic valves.

AIMS: The aim of this meta-analysis was to evaluate the evidence regarding the rates of procedural success and the incidence of adverse outcomes following valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) in patients with failed bioprosthetic aortic valves. METHODS AND RESULTS: A systematic search of major electronic databases was conducted for studies relevant to patients with failed bioprosthetic aortic valves undergoing VIV-TAVR. The primary outcome was procedural success. A total of 5,553 patients from 24 studies were included. The mean Society of Thoracic Surgeons (STS) score was 7.84±5.14. The procedural success rate was high (97%, 95% confidence interval [CI]: 94-98%). At 30 days, all-cause mortality was 5% (95% CI: 3-6%), stroke 2% (95% CI: 1-2%), myocardial infarction 1% (95% CI: 1-2%), permanent pacemaker placement 6% (95% CI: 5-8%), and aortic regurgitation 7% (95% CI: 5-10%). At one year, the incidence of all-cause mortality was 12% (95% CI: 10-14%), stroke 3% (95% CI: 2-4%), myocardial infarction 1% (95% CI: 0-2%), and permanent pacemaker placement 7% (95% CI: 5-11%). At three years, the incidence of all-cause mortality was 29% (95% CI: 25-34%) and stroke 6% (95% CI: 5-9%). CONCLUSIONS: VIV-TAVR appears to be associated with high procedural success rates and low adverse outcomes during the short-term and midterm follow-up period.

Incidence, Clinical Presentation, and Causes of 30-Day Readmission Following Hospitalization With Spontaneous Coronary Artery Dissection.

OBJECTIVES: The aim of this study was to investigate the impact of spontaneous coronary artery dissection (SCAD) on 30-day readmission rates following hospitalization with acute myocardial infarction (AMI) using a national database. BACKGROUND: AMI in the setting of SCAD represents an uncommon type of myocardial infarction with limited data on short-term outcomes. METHODS: All hospitalizations with primary or index diagnoses of AMI from 2010 to 2015 in the Nationwide Readmissions Database were queried. The primary outcome was overall 30-day readmission rates in both SCAD and non-SCAD cohorts. Propensity score matching (1:2) was conducted. RESULTS: A total of 2,654,087 patients with AMI were included in the final analysis, of whom 1,386 (0.052%) were diagnosed with SCAD. SCAD was associated with a higher readmission rate in the SCAD cohort (12.3% vs. 9.9%; p = 0.022). The main causes of readmissions in the SCAD cohort were cardiac causes (80.6%), and AMI was the most common cardiac cause (44.8%), followed by chest pain (20.1%) and arrhythmia (12.7%). Among the SCAD readmissions, 50.6% patients were readmitted in the first week post-discharge, with 54.5% of AMI readmissions occurring in the first 2 days post-discharge. CONCLUSIONS: The incidence of 30-day readmission following AMI and SCAD is nontrivial and occurs early post-discharge. Most readmissions are due to cardiac causes, especially AMI. Targeted management approaches are needed to diminish the high rates of readmission and early recurrent AMI.

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.

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.

Unilateral Access Is Safe and Facilitates Peripheral Bailout During Transfemoral-Approach Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to compare the rate and trend of vascular complications when placing a second arterial sheath in the contralateral femoral artery during transcatheter aortic valve replacement (TAVR) unilaterally versus bilaterally. BACKGROUND: Vascular complications occur in approximately 5% to 8% of TAVR procedures. Many operators place a second arterial sheath in the contralateral femoral artery to perform aortic root angiography. The authors surmised that placing the second sheath ipsilateral and distal to the delivery sheath would be an easier option with similar safety. METHODS: The Cleveland Clinic Aortic Valve Center TAVR database was accessed, and data for patients undergoing transfemoral TAVR (TF-TAVR) from January 2014 to December 2017 were analyzed retrospectively. The primary outcome was the rate of peripheral vascular complications. RESULTS: A total of 1,208 patients who underwent TF-TAVR were included in this study. One thousand seven patients (83.36%) underwent bilateral femoral access, and 201 patients (16.64%) underwent TF-TAVR using a unilateral femoral approach. Over the study duration, use of the unilateral access approach trended upward significantly, reaching 43.7% of total cases in 2017. A gradual decline in access site-related vascular complications was observed, from 13.7% in 2014 to 7.4% in 2017. After propensity-score matching, peripheral vascular complications were similar between bilateral access and unilateral access (10.8% vs. 8.6%) (p = 0.543). CONCLUSIONS: There was a significant decline in vascular complications from 2014 to 2017. Unilateral-access TF-TAVR provided similar safety compared with bilateral-access TF-TAVR and is a more accessible approach for managing access site-related complications and possibly achieving better patient satisfaction.