Highlights of Cardiovascular Disease Prevention Studies Presented at the 2022 European Society of Cardiology Congress.

PURPOSE OF REVIEW: Focused review of select studies presented at the 2022 European Society of Cardiology Congress. RECENT FINDINGS: Included studies assessed the effects of aspirin and omega-3 fatty acid supplements on heart failure (ASCEND study); the impact of icosapent ethyl on ST-elevation MI incidence (REDUCE-IT); air temperature's effect on cardiovascular mortality (EXHAUSTION project); LVEF outcomes after troponin-guided neurohormonal blockade for the prevention of anthracycline toxicity; efficacy of routine stress testing after high-risk PCI (POST-PCI trial); influenza vaccine among patients with acute coronary syndromes (VIP-ACS trial); empagliflozin in patients with acute myocardial infarction (EMMY); effects of comprehensive imaging-based cardiovascular screening on death and cardiovascular events (DANCANVAS); safety of long-term evolocumab in patients with established atherosclerotic cardiovascular disease (FOURIER-OLE); and use of a cardiovascular polypill as a global strategy to improve secondary prevention (SECURE). Research presented at the 2022 ESC Congress highlighted many novel applications of preventative and treatment strategies in cardiology, including the effects of environmental risk factors on the incidence of cardiovascular disease.

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.

Two-year outcomes after transcatheter aortic valve-in-valve implantation in degenerated surgical valves.

BACKGROUND: Transcatheter aortic valve-in-valve implantation (ViV-TAVI) has emerged in recent years as a safe alternative to redo surgery in high-risk patients. Although early results are encouraging, data beyond short-term outcomes are lacking. Herein, we aimed to assess the 2-year outcomes after ViV-TAVI. METHODS: Patients undergoing ViV-TAVI for degenerated surgical valves between 2013 and 2019 at the Cleveland Clinic were reviewed. The coprimary endpoints were all-cause mortality and congestive heart failure (CHF) hospitalizations. We used time-to-event analyses to assess the primary outcomes. Further, we measured the changes in transvalvular gradients and the incidence of structural valve deterioration (SVD). RESULTS: One hundred and eighty-eight patients were studied (mean age = 76 years; 65% males). At 2 years of follow-up, all-cause mortality and CHF hospitalizations occurred in 15 (8%) and 28 (14.9%) patients, respectively. On multivariable analysis, the postprocedural length of stay was a significant predictor for both all-cause mortality (hazard ratio [HR] = 1.1; 95% confidence interval [CI]: 1.01, 1.19) and CHF hospitalization (HR = 1.16; 95% CI: 1.07, 1.27). However, the internal diameter of the surgical valve was not associated with significant differences in both primary endpoints. For hemodynamic outcomes, nine patients (4.8%) developed SVD. The mean and peak transvalvular pressure gradients remained stable over the follow-up period. CONCLUSION: ViV-TAVI for degenerated surgical valves was associated with favorable 2-year clinical and hemodynamic outcomes. Further studies are needed to better understand the role of ViV-TAVI as a treatment option in the life management of aortic valve disease.

Global, Regional, and National Burden of Calcific Aortic Valve and Degenerative Mitral Valve Diseases, 1990-2017.

BACKGROUND: Nonrheumatic valvular diseases are common; however, no studies have estimated their global or national burden. As part of the Global Burden of Disease Study 2017, mortality, prevalence, and disability-adjusted life-years (DALYs) for calcific aortic valve disease (CAVD), degenerative mitral valve disease, and other nonrheumatic valvular diseases were estimated for 195 countries and territories from 1990 to 2017. METHODS: Vital registration data, epidemiologic survey data, and administrative hospital data were used to estimate disease burden using the Global Burden of Disease Study modeling framework, which ensures comparability across locations. Geospatial statistical methods were used to estimate disease for all countries, because data on nonrheumatic valvular diseases are extremely limited for some regions of the world, such as Sub-Saharan Africa and South Asia. Results accounted for estimated level of disease severity as well as the estimated availability of valve repair or replacement procedures. DALYs and other measures of health-related burden were generated for both sexes and each 5-year age group, location, and year from 1990 to 2017. RESULTS: Globally, CAVD and degenerative mitral valve disease caused 102 700 (95% uncertainty interval [UI], 82 700-107 900) and 35 700 (95% UI, 30 500-42 500) deaths, and 12.6 million (95% UI, 11.4 million-13.8 million) and 18.1 million (95% UI, 17.6 million-18.6 million) prevalent cases existed in 2017, respectively. A total of 2.5 million (95% UI, 2.3 million-2.8 million) DALYs were estimated as caused by nonrheumatic valvular diseases globally, representing 0.10% (95% UI, 0.09%-0.11%) of total lost health from all diseases in 2017. The number of DALYs increased for CAVD and degenerative mitral valve disease between 1990 and 2017 by 101% (95% UI, 79%-117%) and 35% (95% UI, 23%-47%), respectively. There is significant geographic variation in the prevalence, mortality rate, and overall burden of these diseases, with highest age-standardized DALY rates of CAVD estimated for high-income countries. CONCLUSIONS: These global and national estimates demonstrate that CAVD and degenerative mitral valve disease are important causes of disease burden among older adults. Efforts to clarify modifiable risk factors and improve access to valve interventions are necessary if progress is to be made toward reducing, and eventually eliminating, the burden of these highly treatable diseases.

Causes of Death Following Nonmetastatic Colorectal Cancer Diagnosis in the U.S.: A Population-Based Analysis.

INTRODUCTION: Because of the improved colorectal cancer (CRC) survival in the U.S., patients may live long enough after CRC diagnosis to the point where non-cancer-related comorbidities may considerably impact their overall survival. In this study, we perform a long-term analysis of causes of death (CODs) following nonmetastatic CRC with respect to different demographic and tumor-related criteria. MATERIALS AND METHODS: We gained access to the Surveillance, Epidemiology, and End Results data to review patients diagnosed with nonmetastatic CRC during 2000-2015. We calculated standardized mortality ratios (SMRs) for each COD following CRC. SMRs represented the change of risk of a specific COD following CRC diagnoses when compared with the risk in the general U.S. RESULTS: We reviewed 302,345 patients, of whom 112,008 died during the study period. More deaths (68.3%) occurred within 5 years following nonmetastatic CRC diagnosis, with 76,486 deaths. CRC was the most common COD (51.4%) within 5 years of diagnosis followed by heart disease (15.2%) and other cancers (8.4%). As time passed after diagnosis, the number of CRC deaths decreased, and other noncancer causes increased to the point that after 10 years only 10.4% of deaths were attributed to CRC, 15.3% were attributed to other cancers, and 34.2% were secondary to heart disease. CONCLUSION: Following nonmetastatic CRC diagnosis, most deaths remain secondary to CRC. Other causes, including other cancers and cardiovascular disease, represent a significant number of deaths, especially in the 5 years following initial CRC diagnosis. Our findings help guide counseling patients with CRC regarding future health risks. IMPLICATIONS FOR PRACTICE: Most common causes of death following nonmetastatic colorectal cancer (CRC) are heart diseases, other cancers, chronic obstructive pulmonary disease, and cerebrovascular diseases. Physicians should counsel patients regarding survivorship with cancer screening and focus on prevention of noncancer deaths. These findings should be considered by physicians who give care for survivors of nonmetastatic CRC.

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.

Temporal trends, outcomes, and predictors of mortality after pericardiocentesis in the United States.

BACKGROUND: Data regarding the temporal trends, outcomes, and predictors of in-hospital mortality after pericardiocentesis are limited. METHODS: The National Inpatient Sample database was used to extract hospitalizations of patients who underwent pericardiocentesis from January 2007 to September 2015. We examined the rates of in-hospital mortality, its predictors, and the temporal trends of pericardiocentesis utilization in the United States during the study period. We also examined trends and outcomes of pericardiocentesis associated with different cardiovascular procedures. RESULTS: A total of 96,377 hospitalizations with pericardiocentesis were examined. The number of pericardiocentesis procedures performed trended up significantly between 2007 and 2015 (p trend <.001), and this increase was observed predominantly in patients with unstable conditions. In-hospital mortality after pericardiocentesis decreased over time (14.6% in 2007 vs. 12.0% in 2015, p trend <.001), but remained higher than that after surgical pericardial intervention (13.1 vs. 8.9%, p value <.0001), predominantly attributable to a higher patient risk profile. Rates of in-hospital mortality were not statistically different between the procedural cohort and the nonprocedural cohort, 13.5 versus 13.0%, p value = .051. After multivariable adjustment, structural heart interventions (odds ratio [OR] 2.86; 95% confidence interval [CI] 2.35-3.49), bacterial and/or infective endocarditis (OR 2.09; 95% CI 1.72-2.54) and active neoplasms (OR 1.72; 95% CI 1.6-1.85) were independently associated with increased in-hospital mortality in pericardiocentesis patients. CONCLUSION: In this nationwide analysis, the number of pericardiocentesis procedures increased significantly over time. Structural interventions, endocarditis, and active neoplasms were associated with increased in-hospital mortality after pericardiocentesis.

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.

Epidemiology of Large Bowel Carcinoid Tumors in the USA: A Population-Based National Study.

BACKGROUND AND AIMS: Prior studies have shown that about 90% of all carcinoid tumors occur in the GI tract. However, epidemiological studies of these tumors have been limited by small sample size. Our aim was to obtain a more robust epidemiologic survey of large bowel carcinoids (LBC), using population-based data in order to more accurately identify risk factors for these tumors. METHODS: We used a commercial database (Explorys Inc, Cleveland, OH) which includes electronic health record data from 26 major integrated US healthcare systems. We identified all patients aged 18 and older who were diagnosed with LBC, excluding appendiceal carcinoids, between 1999 and 2018 based on Systematized Nomenclature Of Medicine-Clinical Terms (SNOMED-CT) and evaluated the prevalence of LBC. We also performed univariate analysis to describe age-, race-, and gender-based distributions and to identify potential risk factors. RESULTS: Of the 62,817,650 individuals in the database, 4530 were identified to have LBC with an overall prevalence of 7.21/100,000. Individuals with LBC were more likely to be elderly (age > 65) [OR 2.17, CI 2.05-2.31, p < 0.0001], smokers [OR 3.25; 95% CI 3.00-3.53, p < 0.0001], have a history of alcohol use [OR 3.75; 95% CI 3.52-3.99, p < 0.0001], diabetes mellitus (DM) [OR 4.42; 95% CI 4.14-4.72, p < 0.0001], obesity [OR 1.58; 95% CI 1.43-1.74, p < 0.0001], family history of cancer [OR 8.06; 95% CI 7.47-8.71, p < 0.0001], and personal history of ulcerative colitis [OR 6.93; 95% CI 5.55-8.64, p < 0.0001] or Crohn's disease [OR 6.45; 95% CI 5.24-7.95, p < 0.0001]. The prevalence of LBC was less among Caucasians compared to African-Americans [OR 0.57; 95% CI 0.53-0.61, p < 0.0001]. There was no statistically significant gender-based difference; men versus women [OR 1.02; 95% CI 0.96-1.08, p = 0.47]. The most common presenting symptoms included flushing, diarrhea, nausea, weight loss, and abdominal pain, while the most common GI associations included perforation, obstruction, hemorrhage, intussusception, and volvulus. CONCLUSION: This is the largest epidemiological study evaluating the prevalence of LBC. We estimated the prevalence rate of LBC to be 7.21/100,000. The presence of significant risk factors with the clinical picture suspicious for a LBC should warrant thorough evaluation as these tumors can lead to life-threatening complications. Further studies are needed to better understand the mechanism of association between these risk factors and LBC.

Efficacy and safety of aspirin for primary prevention of cardiovascular events: a meta-analysis and trial sequential analysis of randomized controlled trials.

AIMS: The role of aspirin in the primary prevention setting is continuously evolving. Recent randomized trials have challenged the role of aspirin in the primary prevention setting. METHODS AND RESULTS: Electronic databases were searched for randomized trials that compared aspirin vs. placebo (or control) in subjects without established atherosclerotic disease. The primary efficacy outcome was all-cause mortality, while the primary safety outcome was major bleeding. Summary estimates were reported using a DerSimonian and Laird random effects model. A total of 11 trials with 157 248 subjects were included. At a mean follow-up of 6.6 years, aspirin was not associated with a lower incidence of all-cause mortality [risk ratio (RR) 0.98, 95% confidence interval (CI) 0.93-1.02; P = 0.30]; however, aspirin was associated with an increased incidence of major bleeding (RR 1.47, 95% CI 1.31-1.65; P < 0.0001) and intracranial haemorrhage (RR 1.33, 95% CI 1.13-1.58; P = 0.001). A similar effect on all-cause mortality and major bleeding was demonstrated in diabetic and high cardiovascular risk patients (i.e. 10-year risk >7.5%). Aspirin was associated with a lower incidence of myocardial infarction (RR 0.82, 95% CI 0.71-0.94; P = 0.006); however, this outcome was characterized by considerable heterogeneity (I2 = 67%), and this effect was no longer evident upon limiting the analysis to the more recent trials. Trial sequential analysis confirmed the lack of benefit of aspirin for all-cause mortality up to a relative risk reduction of 5%. CONCLUSION: Among adults without established cardiovascular disease, aspirin was not associated with a reduction in the incidence of all-cause mortality; however, it was associated with an increased incidence of major bleeding. The routine use of aspirin for primary prevention needs to be reconsidered.

Suicidal death within a year of a cancer diagnosis: A population-based study.

BACKGROUND: The suicide risk after a new cancer diagnosis remains a controversial issue. This study examines the suicide risk within the year after a cancer diagnosis. This is the largest study to assess recent trends in suicide risk after a cancer diagnosis. METHODS: Data were obtained from the Surveillance, Epidemiology, and End Results Program. All patients diagnosed with cancer between 2000 and 2014 were selected. The event was defined as death due to suicide within the first year after a cancer diagnosis, and patients who experienced the event after their diagnosis were observed. The observed/expected (O/E) ratio was assessed as well as the excess risk per 10,000 person-years to determine the suicide risk change after the diagnosis in comparison with the general population. RESULTS: A total of 4,671,989 patients with cancer were included; 1585 committed suicide within 1 year of their diagnosis. The risk of suicide increased significantly with an O/E ratio of 2.52 and with an excess risk of 2.51 per 10,000 person-years. When the risk of suicide was studied according to the cancer site, the highest increases in the O/E ratio came after diagnoses of pancreatic cancer (8.01) and lung cancer (6.05). The risk of suicide also increased significantly after a diagnosis of colorectal cancer with an O/E ratio of 2.08. However, the risk of suicidal death did not increase significantly after breast and prostate cancer diagnoses. CONCLUSIONS: The risk of suicide increases significantly in the first year after a diagnosis of cancer in comparison with the general population, and this increase varies with the type and prognosis of cancer. Close observation and referral to mental health services, when indicated, are important for mitigating such risk.

Outcome disparities in colorectal cancer: a SEER-based comparative analysis of racial subgroups.

PURPOSE: Previous studies of ethnic disparities in colorectal cancer (CRC) have focused mainly on patients of Caucasian and African-American descent. We aimed to evaluate outcomes for a range of races, representing a broader demographic of the US population. METHODS: The Surveillance, Epidemiology, and End Results database was queried to identify patients with CRC diagnosed between 1994 and 2014. We performed unadjusted Kaplan-Meier test and multivariable covariate-adjusted Cox models to calculate the overall and CRC-specific survival of patients according to their race. RESULTS: We identified 401,723 patients diagnosed with CRC between 1994 and 2014. Overall survival (OS) and CRC-specific survival were compared across different races stratified by age, sex, marital status, disease stage and grade, and undergoing surgery as a treatment. Overall, Asian/Pacific Islanders and Hispanics had improved CRC-specific survival compared to Whites (HR = 0.873, 95%CI 0.853-0.893, P < .001, and HR = 0.958, 95%CI 0.937-0.979, P < .001, respectively). Blacks had the worst CRC-specific survival outcomes when compared to Whites (HR = 1.215, 95%CI 1.192-1.238, P < .001). Racial disparity persisted when looking at two different time periods (1994-2003 and 2004-2014). CONCLUSIONS: Asians/Pacific Islanders have improved outcomes from CRC compared to other races. Multifactorial, including genetic, environmental, and socioeconomic factors appear to influence outcomes and need to be addressed separately in order to reduce racial disparities among patients with CRC.

Is There a Safety Concern for Drug-Coated Balloons in Peripheral Arterial Disease?

PURPOSE OF REVIEW: Drug-coated balloons (DEB) and drug-eluting stents (DES) emerged as a tool to aid in lowering the rates of neointimal hyperplasia and target lesion restenosis following endovascular peripheral arterial disease (PAD) interventions. RECENT FINDINGS: Although the initial trials comparing these devices with non-drug balloons and stents showed favorable results, more recent data raised concerns regarding the mid to long-term safety of these devices. In this review, we will discuss the evolution of endovascular therapy for PAD, with highlights regarding the recent debates on the long-term safety of the drug-coated devices for treatment of PAD.