Cumulative All-cause Mortality Research Articles

Effect of Xpert MTB/RIF on clinical outcomes in routine care settings: individual patient data meta-analysis.

SummaryBackgroundXpert MTB/RIF, the most widely used automated nucleic acid amplification test for tuberculosis, is available in more than 130 countries. Although diagnostic accuracy is well documented, anticipated improvements in patient outcomes have not been clearly identified. We performed an individual patient data meta-analysis to examine improvements in patient outcomes associated with Xpert MTB/RIF.MethodsWe searched PubMed, Embase, ClinicalTrials.gov, and the Pan African Clinical Trials Registry from inception to Feb 1, 2018, for randomised controlled trials (RCTs) comparing the use of Xpert MTB/RIF with sputum smear microscopy as tests for tuberculosis diagnosis in adults (aged 18 years or older). We excluded studies of patients with extrapulmonary tuberculosis, and studies in which mortality was not assessed. We used a two-stage approach for our primary analysis and a one-stage approach for the sensitivity analysis. To assess the primary outcome of cumulative 6-month all-cause mortality, we first performed logistic regression models (random effects for cluster randomised trials, with robust SEs for multicentre studies) for each trial, and then pooled the odds ratio (OR) estimates by a fixed-effects (inverse variance) or random-effects (Der Simonian Laird) meta-analysis. We adjusted for age and gender, and stratified by HIV status and previous tuberculosis-treatment history. The study protocol has been registered with PROSPERO, number CRD42014013394.FindingsOur search identified 387 studies, of which five RCTs were eligible for analysis. 8567 adult clinic attendees (4490 [63·5%] of 7074 participants for whom data were available were HIV-positive) were tested for tuberculosis with Xpert MTB/RIF (Xpert group) versus sputum smear microscopy (sputum smear group), across five low-income and middle-income countries (South Africa, Brazil, Zimbabwe, Zambia, and Tanzania). The primary outcome (reported in three studies) occurred in 182 (4·5%) of 4050 patients in the Xpert group and 217 (5·3%) of 4093 patients in the smear group (pooled adjusted OR 0·88, 95% CI 0·68–1·14 [p=0·34]; for HIV-positive individuals OR 0·83, 0·65–1·05 [p=0·12]). Kaplan-Meier estimates showed a lower rate of death (12·73 per 100 person-years in the Xpert group vs 16·38 per 100 person-years in the sputum smear group) for HIV-positive patients (hazard ratio 0·76, 95% CI 0·60–0·97; p=0·03). The risk of bias was assessed as reasonable and the statistical heterogeneity across studies was low (I2<20% for the primary outcome).InterpretationDespite individual patient data analysis from five RCTs, we were unable to confidently rule in nor rule out an Xpert MTB/RIF-associated reduction in mortality among outpatients tested for tuberculosis. Reduction in mortality among HIV-positive patients in a secondary analysis suggests the possibility of population-level impact.

Predictors of mortality and outcomes after retrograde endovascular angioplasty in patients with peripheral artery disease.

IntroductionEndovascular revascularization (ER) techniques in patients with peripheral artery disease (PAD) have been developed and became more accessible in recent years. The ER is a first-line treatment in the majority of patients with symptomatic PAD. However, data on assessment of predictors of long-term outcomes of retrograde ER in patients with PAD are scarce.AimTo evaluate predictors of long-term outcomes of retrograde ER in patients with chronic total occlusion in lower limb arteries.Material and methodsWe analyzed data of 834 patients who underwent retrograde ER. Baseline clinical characteristics and procedural data were collected. Patients were followed up for 36 months, and the primary endpoint was all-cause mortality.ResultsAll patients were symptomatic and had failed antegrade ER. The procedural success rate was 92%. Cumulative all-cause mortality was 13.4% at 36-month follow-up. In multivariate analysis history of stroke, Rutherford category, chronic limb ischemia, chronic kidney disease (CKD), chronic obstructive pulmonary disease (COPD) and previous ER of other lesion were independent predictors of a higher mortality rate after 36 months (hazard ratio (HR) for stroke 2.4, 95% confidence interval (CI): 1.55–3.66; p = 0.0002; HR for age per 10 years 1.37, 95% CI: 1.15–1.64; p = 0.0002; HR for Rutherford category 1.63, 95% CI: 1.35–1.98; p < 0.0001, HR for chronic limb ischemia 0.44, 95% CI: 0.25–0.8, p = 0.007; HR for CKD 1.73, 95% CI: 1.14–2.56, p = 0.01; HR for COPD 2.4, 95% CI: 1.5–3.7, p = 0.0004; HR for previous ER 0.59, 95% CI: 0.35–0.94, p = 0.02).ConclusionsHistory of stroke, Rutherford category, chronic limb ischemia, CKD, COPD, and previous ER of other lesion were independently associated with increased risk of all-cause death.

Impact of Increased Right Atrial Size on Long-Term Mortality in Patients With Heart Failure Receiving Cardiac Resynchronization Therapy

The ability to visualize the right atrium (RA) by echocardiography allows a quantitative, highly reproducible assessment of the RA volume (RAV). The aim of this study is to evaluate the relation between RAV and long-term mortality in a prospective cohort of heart failure and reduced ejection fraction patients in sinus rhythm receiving cardiac resynchronization therapy. 172 patients were included. The right atrium volume index (RAVI) was calculated using Simpson's method from the apical four-chamber view and indexed to body surface area. The relation between RAVI and mortality during follow up was studied. Median follow up was 68 months (interquartile range 62 to 73 months). Mean RAVI was 27 ± 14 mL/m² (IQR 22 to 33 mL/m²). Cumulative 5-year all-cause mortality was 22 ± 6% in patients with RAVI ≤ 19 mL/m², 24 ± 6% for RAVI 19 to 29 mL/m² and 58 ± 7% for RAVI >29 mL/m² (p for trend <0.001). After adjustment on clinical and echocardiographic predictors of outcome including indices of right ventricular function, there was a significant increase in overall mortality risk with increasing RAVI (adjusted hazard ratio 1.02 [95% confidence interval, 1.00 to 1.03], per 1 mL/m2 increment; p = 0.042). Patients in the highest tertile (RAVI >29 mL/m²) had significantly greater risk of death compared with those with RAVI ≤29 mL/m² (adjusted hazard ratio 2.01 [95% confidence interval, 1.15 to 3.50]; p = 0.014). In conclusion, RA enlargement is a powerful and highly reproducible independent predictor of long-term mortality in patients with heart failure and reduced ejection fraction in sinus rhythm receiving cardiac resynchronization therapy.

Effect of evidence-based cardiac drug therapy on mortality in patients with acute coronary syndrome: Findings from the Gulf COAST registry.

To evaluate the prevalence and impact of the prescribing of an evidence-based cardiac medication (EBM) combination on 1-month, 6-months, and 12-months all-cause mortality in patients with acute coronary syndrome (ACS). Data were analyzed from 3681 consecutive patients diagnosed with ACS admitted to 29 hospitals in 4 Middle Eastern countries from January 2012 to January 2013. The EBM combination consisted of concurrent prescribing of an antiplatelet therapy, angiotensin-converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB), β-blocker, and a statin, at hospital discharge. Analyses were performed using univariate and multivariate statistical techniques. The overall mean age of the cohort was 60±13years, 66% (n=2436) were males. In all, 69% (n=2542) of the patients received the quadruple EBM combination at discharge. Two-way interactions between EBM and age (P=0.824), EBM and GRACE risk score (P=0.873) and between EBM and discharge diagnosis (P=0.836) were all not statistically significant. Adjusting for demographic and clinical characteristics, the prescribing of EBM combination was associated with significantly lower cumulative all-cause mortality at 1-month (adjusted OR (aOR), 0.43; 95% confidence interval (CI): 0.24-0.79; P=0.007), which persisted at 6-months (aOR, 0.52; 95% CI: 0.38-0.72; P<0.001) and at 12-months of follow-up (aOR, 0.58; 95% CI: 0.44-0.75; P<0.001) posthospital discharge. Among patients discharged after an ACS event, concurrent EBM prescribing was associated with lower all-cause mortality that persists for up to 12-months posthospital discharge. The relative benefits of EBMs were also consistent across age, GRACE risk score, and discharge diagnosis.

Frequency and Consequences of Cognitive Impairmentin Patients Underwent Transcatheter Aortic Valve Implantation

Cognitive impairment is common in patients underwent transcatheter aortic valve implantation (TAVI) and might affect procedure outcomes. This study evaluated the incidence of preprocedural cognitive impairment and its impact on clinical outcomes after TAVI. We analyzed the data of 1,111 patients (age ≥70 years) obtained from the Optimized CathEter vAlvular iNtervention (OCEAN-TAVI) registry. The cognitive performance of all patients was assessed using the Mini-Mental State Examination (MMSE) at baseline. We evaluated the 1-year cumulative mortality after TAVI according to the MMSE performance. Cognitive impairment was present in 420 (38%) of 1,111 patients. Compared with patients with normal cognition, those with cognitive impairment showed higher cumulative all-cause and noncardiovascular mortality rates at 1 year (14% vs. 8%, p = 0.001; 11% vs. 5%, p <0.001, respectively). Moreover, cognitive impairment increased the risk of mortality from sepsis (2% vs. 0.4%; hazard ratio, 4.2; 95% confidence interval, 1.3 to 13.5; p = 0.02). In adjusted models, cognitive impairment was an independent risk factor for 1-year all-cause mortality (adjusted hazard ratio, 2.1; 95% confidence interval, 1.1 to 4.0; p = 0.02). Although patients with cognitive impairment had more in-hospital adverse outcomes, including prolonged hospital stays, major bleeding and vascular complications, and acute kidney injury, than did those with normal cognition, the 30-day mortality was similar between the groups (1% in the two groups; p >0.99). In conclusion, cognitive impairment based on the MMSE score was an independent predictor of mortality at 1 year after TAVI.

Incremental risk of long-term mortality with increased burden of comorbidity in hospitalized patients with pneumonia

BackgroundPatients hospitalized for pneumonia often have concurrent comorbid conditions (CCs). The influence of CCs on the risk of subsequent death is not fully understood. MethodsWe examined adults hospitalized for pneumonia between 1996 through 2015 at Mayo Clinic for the presence of 20 priori selected CCs. We estimated cumulative all-cause mortality by number of CCs using multivariable Cox regression model. ResultsStudy comprised of 9580 adults (age 70 ± 17.0 years, men 53%, whites 88%) with median number of CCs 3 (interquartile 1–4), and overall deaths 6032 (62.9%) during 50,934 person-years of follow up (118.5 deaths/1000 person-years). After adjustment, any single comorbid condition was associated with 9% greater risk of death (95% confidence interval 1.08–1.11, P < 0.0001). When study cohort was stratified according to number of comorbidities (none, 1, 2, 3, 4, 5, and ≥6 CCs), the risk of death increased as the number of CCs increased (33 for no CCs vs 252 deaths for ≥6 CCs per 1000 person-years). ConclusionsLong-term mortality after hospitalization for pneumonia increases as the burden of comorbidities increases. Therefore, a simple comorbidity count help improve prognostic accuracy in identifying patients at increased risk of death following an episode of pneumonia.

Results from the Study to Assess Outcomes After Endovascular Repair for Multiple Thoracic Aortic Diseases (SUMMIT)

ObjectiveThoracic endovascular aortic repair (TEVAR) is currently the treatment of choice for most diseases of the descending thoracic aorta. Using data from the Study to Assess Outcomes After Endovascular Repair for Multiple Thoracic Aortic Diseases (SUMMIT) study we investigated the outcomes of TEVAR for different aortic diseases and risk factors associated with the outcomes. MethodsThe SUMMIT study included aggregated data of 521 TEVAR patients from five Cook-sponsored multicenter trials evaluating thoracic endografts of the Zenith platform (William Cook Europe, ApS, Bjaeverskov, Denmark). In this post hoc analysis, primary outcomes include 30-day and 1-year mortality and morbidity and cumulative mortality and reinterventions. Cox regression analyses were performed to identify risk factors for mortality and reinterventions. ResultsOf the 521 patients (67% male; mean age, 67.2 ± 15 years), 329 were treated for thoracic aortic aneurysms, 56 for thoracic ulcers, 55 for acute and 31 for nonacute type B aortic dissections (TBADs), and 50 for blunt thoracic aortic injuries. The overall 30-day mortality rate was 1.7%, with perioperative stroke occurring in 3.1%, paraplegia in 1.2%, and proximal type I endoleak in 0.4% of patients within 30 days. At 1 year, the cumulative rate was 8.1% for all-cause mortality, 4.0% for stroke, 1.2% for paraplegia, 0.8% for proximal type I endoleak, and 6.0% for secondary interventions. Multivariate analysis showed that significant predictors for all-cause mortality included age (hazard ratio [HR], 1.04 for each additional year), congestive heart failure (HR, 2.87), serum creatinine (HR, 1.19 per 1 mg/dL), iliac tortuosity (HR, 1.32), blood transfusion (HR, 1.59 per 500 mL of packed red blood cells), and occurrence of 30-day stroke (HR, 3.93), paraplegia (HR, 7.79), or paraparesis (HR, 2.46). Patients treated for dissection, but not for thoracic aortic aneurysm or blunt thoracic aortic injury, demonstrated significantly higher risk for reintervention (HR, 5.65 for acute and 6.60 for nonacute TBADs) compared with patients treated for thoracic ulcers (reference group). Intraoperative contrast material (HR, 1.31 per 100 mL) and blood transfusion volumes (HR, 1.42 per 500 mL of packed red blood cells), surrogates of case complexity, were also significant predictors for reintervention. ConclusionsThe results from the SUMMIT study demonstrated exceptionally low mortality and stroke rates at 30 days and low aortic disease-related mortality during follow-up. TBAD is associated with a higher risk for reintervention, possibly attributed to the natural history of the disease, whereas age, reduced cardiac and renal functions, difficult iliac access anatomy, intraoperative transfusion, and early neurologic complications are associated with higher risk for cumulative all-cause mortality.

Increased mortality and ICD therapies in ischemic versus non-ischemic dilated cardiomyopathy patients with cardiac resynchronization having survived until first device replacement.

IntroductionCardiac resynchronization therapy combined with an implantable cardioverter defibrillator (CRT-D) is widely applied in heart failure patients. Sufficient data on arrhythmia and defibrillator therapies during long-term follow-up of more than 4 years are lacking and data on mortality are conflicting. We aimed to characterize the occurrence of ventricular arrhythmia, respective defibrillator therapies and mortality for several years following CRT-D implantation or upgrade.Material and methodsEighty-eight patients with ischemic (ICM) or non-ischemic dilated cardiomyopathy (DCM) and at least one CRT-D replacement were included in this study and analyzed for incidence of non-sustained ventricular tachycardia (NSVT), defibrillator shocks, anti-tachycardia pacing (ATP) and mortality.ResultsICM was the underlying disease in 59%, DCM in 41% of patients. During a mean follow-up of 76.4 ±24.8 months the incidence of appropriate defibrillator therapies (shock or ATP) was 46.6% and was elevated in ICM compared to DCM patients (57.7% vs. 30.6%, respectively; p = 0.017). Kaplan-Meier analysis revealed significantly higher ICD therapy-free survival rates in DCM patients (p = 0.031). Left ventricular ejection fraction, NSVT per year and ICM (vs. DCM) were independent predictors of device intervention. The ICM patients showed increased mortality compared to DCM patients, with cumulative all-cause mortality at 9 years of follow-up of 45.4% and 10.6%, respectively. Chronic renal failure, peripheral artery disease and chronic obstructive pulmonary disease were independent predictors of mortality.ConclusionsThe clinical course of patients with ICM and DCM treated with CRT-D differs significantly during long-term follow-up, with increased mortality and incidence of ICD therapies in ICM patients.

Incidence, Predictors, and Clinical Impact of Prosthesis–Patient Mismatch Following Transcatheter Aortic Valve Replacement in Asian Patients: The OCEAN-TAVI Registry

ObjectivesThe authors sought to investigate the prevalence, risk factors, and mid-term mortality in Asian patients with prosthesis–patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR). BackgroundLittle information is available on PPM after TAVR in Asian patients. MethodsThe authors included 1,558 patients enrolled in the OCEAN-TAVI (Optimized transCathEter vAlvular iNtervention) Japanese multicenter registry from October 2013 to July 2016 after excluding patients who died following TAVR before discharge. PPM was defined as moderate if ≧0.65 but ≦0.85 cm2/m2, or severe if <0.65 cm2/m2 at the indexed effective orifice area by post-procedural echocardiography. ResultsOf the 1,546 patients, moderate and severe PPM were observed in 138 (8.9%) and 11 (0.7%) patients, respectively. These 149 patients were included in the PPM group. The median age and body surface area were 85 years (interquartile range [IQR]: 81 to 88 years) and 1.41 m2 (IQR: 1.30 to 1.53 m2), respectively. In our multivariate analysis, younger age, larger body surface area, smaller aortic valve area, smaller annulus area, no balloon post-dilatation, and use of Edwards Sapien 3 (Edwards Lifesciences, Irvine, California) were identified as independent predictors of PPM. The estimated cumulative all-cause mortality at 1 year using the Kaplan-Meier method was similar between the PPM and non-PPM groups (10.2% vs. 8.3%; log-rank; p = 0.41). ConclusionsThe low prevalence of PPM and mortality at 1 year in patients with PPM after TAVR in this Japanese cohort implies that PPM is not a risk factor for mid-term mortality in Asian patients who have undergone TAVR.

Comparision of the treatment and short-term and one-year prognosis from acute heart failure in tertiary hospitals versus secondary hospitals--findings from Beijing Acute Heart Failure Registry (Beijing AHF Registry)

Objective To assess and compare the incidence, clinical characteristics, treatment, and prognosis of acute heart failure patients from different grades hospitals in Beijing. Methods In this prospective internet prognosis registered study (Beijing AHF Registry), a total of 3 335 consecutive patients admitted to 14 emergency departments in Beijing from January 1st 2011 to September 23rd 2012 were enrolled. According to hospital grade, these patients were divided into two groups, 349 patients were from secondary hospitals, and 2 956 patients were from tertiary hospitals. Results Among the 3 335 patients, the medium age was 71 (58, 79) years, and male accounted for 53.16%. The most common underlying disease were coronary disease (43.27%), hypertension (17.73%), cardiomyopathy (16.07%) etc. The average treatment time in Emergency Department was 66.82 h. The emergency department mortality rate was 3.81% (127 cases). The 30-day and 1-year cumulative all-cause mortality were 15.3% and 32.27%, respectively. The 30-day and 1-year cumulative all-cause readmission were 15.64% and 46.89%, respectively. Compared with patients in tertiary hospitals, patients in secondary hospitals had more onset acute heart failure patients (63.64% vs. 49.93%), shorter emergency department treatment time (12 h vs. 41 h) , lower discharge rate (3.43% vs.37.45%) and emergency department mortality(1.58% vs. 4.09%). Compared with those in tertiary hospitals, 1-year cumulative all-cause mortality (25.6% vs.33.2%), cardiovascular disease mortality (20.2% vs.26.0%),aggravated heart failure mortality (22.4% vs.28.8%)were lower in secondary hospitals. Following propensity score matching, compared to tertiary hospitals, patients in secondary hospitals showed lower utilization rate of beta-blockers and ACEI/ARB (4.51% vs. 28.17%, 1.41% vs. 9.58%), except the pironolactone. Conclusion Acute heart failure in emergency department is associated with a high mortality rate and readmission rate. There is still a big gap between guidelines recommend medication current treatments for acute heart failure. Key words: Acute heart failure; Prognosis; Treatment; Mortality; Emergency department

Mortality following hip fractures managed with hemiarthroplasty in the elderly in South Africa

Background: Limited studies are available documenting the demographics and mortality of hip fractures following surgery in South Africa and in Africa. The aim of this study was to evaluate short- and long-term mortality following displaced intracapsular femur neck fractures managed in the elderly with cemented hemiarthroplasty surgery at our institution. Methods: Data was collected from 561 patients who were treated from 1 May 2001 to 30 April 2014. Mortality was confirmed with the National Population Register. Results: The mean age was 77.96 years (SD=9.76) with more female (69.2%) compared to male (30.8%) patients. Male patients presented at a younger age (mean=74.6) than female patients (mean=79.4; p < 0.0001). The incidence of the affected side was similar, with right-sided hip fractures (49%) almost equalling left-sided hip fractures (51%). The overall cumulative all-cause mortality rates for patients were: 12.5% 30 days post-surgery, 22.7% 90 days post-surgery, 27.9% six months post-surgery and 34.3% one year post-surgery, respectively. Conclusion: The results from this study showed a high mortality rate in comparison to international studies. Future research is required to identify risk factors associated with early mortality following hip fractures and this might help improving outcomes in our elderly patient population. Level of evidence: Level 4

EuroSCORE II and the STS score are more accurate in transapical than in transfemoral transcatheter aortic valve implantation.

The European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) and the Society of Thoracic Surgeons (STS) score are currently used to estimate periprocedural risk of death in patients undergoing transcatheter aortic valve implantation (TAVI). However, data regarding the predictive ability and usefulness of these scores for TAVI are controversial, especially for different access sites. Between 2008 and 2016, 1192 consecutive patients undergoing TAVI [transfemoral (TF): n = 607 (51%); transapical (TA): n = 585 (49%)] at 2 centres were included. All-cause mortality was assessed at a median of 533 days (interquartile range 153-1036). The value of the EuroSCORE II and the STS score in terms of predicting 30-day and cumulative mortality according to access site was investigated. The mean age was 83 (interquartile range 79-86) years. Overall, the 30-day mortality rate was 7.6% (n = 90), and the cumulative all-cause mortality rate was 35.1% (n = 418). The EuroSCORE II and the STS score were significantly increased in non-survivors compared with survivors (P < 0.001). The EuroSCORE II and the STS score emerged as independent predictors of 30-day mortality [EuroSCORE II: odds ratio (OR) 1.039, 95% confidence interval (CI) 1.013-1.065; P = 0.003; STS score: OR 1.055, 95% CI 1.023-1.088; P = 0.001] and cumulative all-cause mortality [EuroSCORE II: hazard ratio (HR) 1.026, 95% CI 1.013-1.038; P < 0.001; STS score: HR 1.05, 95% CI 1.03-1.06; P < 0.001]. In contrast to TF TAVI, the EuroSCORE II (OR 1.038, 95% CI 1.009-1.068; P = 0.010) and the STS score (OR: 1.063, 95% CI 1.025-1.102; P = 0.001) were independent predictors of 30-day mortality and cumulative mortality (EuroSCORE II: HR 1.023, 95% CI 1.009-1.037; P = 0.001; STS score: HR 1.055, 95% CI 1.037-1.073; P < 0.001) in patients undergoing TA TAVI. The EuroSCORE II and the STS score were independent predictors of 30-day and cumulative mortality rates in patients undergoing TAVI. The EuroSCORE II and the STS score were associated with 30-day mortality and mortality during follow-up period only in TA TAVI.

Impact of frailty markers on outcomes after transcatheter aortic valve replacement: insights from a Japanese multicenter registry.

There are no standardized criteria for measuring patients' frailty. We examined prognosis based on four frailty markers [serum albumin level, grip strength, gait speed, and clinical frailty scale (CFS)] in patients who underwent transcatheter aortic valve replacement (TAVR) between October 2013 and April 2016 and were recorded in the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese multicenter registry. Serum albumin level was assessed by dividing patients into two groups: hypoalbuminemia or non-hypoalbuminemia according to their serum albumin level. Clinical outcomes including all-cause, cardiovascular and non-cardiovascular mortality rates after TAVR were compared. During the follow-up period cumulative all-cause, cardiovascular and non-cardiovascular mortality rates were significantly higher in the hypoalbuminemia group than in the non-hypoalbuminemia group. This result remained unchanged even after a propensity-matched model was used in terms of cumulative all-cause and non-cardiovascular mortality; however, differences in cardiovascular mortality rates were attenuated. To consider the impact of grip strength patients were divided into a low or high peak grip strength group based on classification and regression tree (CART) survival analysis. The clinical outcomes for each sex were compared between the two groups. In both sexes the cumulative 1-year mortality rates were significantly different between the two groups. To investigate gait speed patients were classified into two gait speed groups (low or high gait speed group) based on CART survival analysis. Clinical outcomes were compared between the two groups. The cumulative 1-year mortality rate was significantly different between the two gait speed groups. The effect of CFS on prognosis after TAVR was assessed. Patients were categorized into five groups based on the following CFS scores: CFS1-3, CFS4, CFS5, CFS6, and CFS ≥7. We evaluated the relationship between the CFS score and other indicators of frailty markers. We also assessed the mid-term mortality among the five groups. The CFS score had a significant correlation with other frailty markers. The cumulative 1-year mortality increased with an increasing CFS score. In the Cox regression multivariable analysis, the CFS score was an independent predictive factor of an increased late cumulative mortality risk. In conclusion, the results suggest that serum albumin level, grip strength, gait speed, and CFS score are all useful indicators when considering the optimal indications and risk stratification for TAVR.

Clinical outcomes and prognostic factors of transcatheter aortic valve implantation in bicuspid aortic valve patients.

The purpose of this study was to evaluate the outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis (AS). From April 2012 and December 2016, 108 patients with bicuspid AS underwent TAVR using the Sapien XT (34 patients) and Sapien 3 (74 patients) valves. Procedural and clinical outcomes were assessed according to VARC-2 criteria and compared between the two devices. In the overall cohort, the majority of patients were male (71.3%) with an intermediate surgical risk and a mean Society of Thoracic Surgeons (STS) score of 5.2%. Compared to the Sapien XT group, the Sapien 3 group had a significantly lower STS score (3.3%±2.0% vs. 6.7%±3.6%; P=0.001). Compared to the Sapien XT group, the Sapien 3 group had a significantly lower rate of moderate or severe paravalvular leak (2.7% vs. 14.7%; P=0.03) and higher device success (97.3% vs. 82.4%; P=0.006). There were no significant differences between the two groups in terms of 30-day all-cause mortality, stroke, life-threatening bleeding, major vascular complication and acute kidney injury (stage 2 or 3). Cumulative all-cause mortality at 1-year follow-up was 6.9%. There were no significant differences in cumulative event rates for all-cause mortality at 1-year follow-up between the two groups (9.4% vs. 4.6%; log-rank P=0.47). By univariate analysis, major vascular complication was significantly associated with overall all-cause mortality [hazard ratios (HR): 7.57; 95% confidence interval (CI): 1.51-37.86; P=0.014]. TAVR using the balloon-expandable valves provided acceptable procedural and clinical outcomes in patients with bicuspid AS. The new-generation Sapien 3 valves showed improved procedural outcomes compared to the early-generation Sapien XT valves.

Prognostic Impact of Low-Flow Severe Aortic Stenosis in Small-Body Patients Undergoing TAVR: The OCEAN-TAVI Registry

ObjectivesThis study aimed to analyze the prognostic impact of low-flow (LF) severe aortic stenosis in small-body patients undergoing transcatheter aortic valve replacement (TAVR). BackgroundWestern literature demonstrates a poor prognosis with paradoxical LF and low-flow low-gradient (LF-LG) severe aortic stenosis (AS), as defined by stroke volume index (SVi) <35 ml/m2 and mean pressure gradient <40 mm Hg with preserved left ventricular ejection fraction (LVEF). However, this poor prognosis is contested in Japan owing to the smaller body size of Japanese patients relative to that of Western patients. Additionally, there are no reports of the prognostic implication of paradoxical LF or LF-LG severe AS in small-body patients undergoing TAVR. MethodsThis was a retrospective analysis of 723 consecutive Japanese patients (median age 85 years; 32.6% male; median body surface area 1.4 m2) who underwent TAVR for severe AS at 9 sites in Japan. The primary and secondary endpoints were cumulative all-cause and cardiovascular mortality after TAVR, respectively. ResultsNinety-seven (13.4%) patients had paradoxical LF severe AS whereas 38 (5.3%) had paradoxical LF-LG with severe AS. PLF was associated with a significant increase in all-cause (hazard ratio [HR]: 3.00; 95% confidence interval [CI]: 1.34 to 6.72; p < 0.001) and cardiovascular mortality (HR: 5.58; 95% CI: 1.19 to 26.2; p < 0.01), as compared with patients’ normal flow and preserved LVEF. PLF-LG was associated with a significant increase in all-cause mortality (HR: 3.76; 95% CI: 1.09 to 13.73; p < 0.01), as compared with normal flow high gradient with preserved LVEF. SVi was an independent predictor of cardiovascular mortality on multivariate analysis after adjustments for age, sex, clinically relevant variables, and other echocardiographic parameters (HR: 1.96; 95% CI: 1.19 to 3.23; p < 0.01). ConclusionsAmong Japanese small-body patients with severe AS, both paradoxical LF and LF-LG severe AS were associated with poor outcomes following TAVR. SVi was an independent predictor of cardiovascular mortality after TAVR. (Optimised Transcatheter Valvular Intervention registry [OCEAN-TAVI]; UMIN000020423)

One-year mortality outcomes and hospital readmissions of patients admitted with acute heart failure: Data from the Trivandrum Heart Failure Registry in Kerala, India

There are sparse data on outcomes of patients with heart failure (HF) from India. The objective was to evaluate hospital readmissions and 1-year mortality outcomes of patients with HF in Kerala, India. We followed 1,205 patients enrolled in the Trivandrum Heart Failure Registry for 1 year. A trained research nurse contacted each participant every 3 months using a structured questionnaire which included hospital readmission and mortality information. The mean (SD) age was 61.2 (13.7) years, and 31% were women. One out of 4 (26%) participants had HF with preserved ejection fraction. Only 25% of patients with HF with reduced ejection fraction received guideline-directed medical therapy at discharge. Cumulative all-cause mortality at 1 year was 30.8% (n = 371), but the greatest risk of mortality was in the first 3 months (18.1%). Most deaths (61%) occurred in patients younger than 70 years. One out of every 3 (30.2%) patients was readmitted at least once over 1 year. The hospital readmission rates were similar between HF with preserved ejection fraction and HF with reduced ejection fraction patients. New York Heart Association functional class IV status and lack of guideline-directed medical treatment after index hospitalization were associated with increased likelihood of readmission. Similarly, older age, lower education status, nonischemic etiology, history of stroke, higher serum creatinine, lack of adherence to guideline-directed medical therapy, and hospital readmissions were associated with increased 1-year mortality. In the Trivandrum Heart Failure Registry, 1 of 3 HF patients died within 1 year of follow-up during their productive life years. Suboptimal adherence to guideline-directed treatment is associated with increased propensity of readmission and death. Quality improvement programs aiming to improve adherence to guideline-based therapy and reducing readmission may result in significant survival benefits in the relatively younger cohort of HF patients in India.

A retrospective analysis of clinical characteristics and outcomes of heart failure patients with different left ventricular ejection fractions

Objective: To compare the clinical characteristics, and outcomes of patients with heart failure with different left ventricular ejection fractions (LVEF). Methods: A total of 1 182 hospitalized patients with heart failure (HF) were enrolled and retrospectively studied in the present study. The patients were stratified by LVEF as reduced (HFrEF, LVEF<40%, n=313), mid-range (HFmrEF, 40% ≤LVEF <50%, n=287) and preserved (HFpEF, LVEF≥50%, n=582) ejection fraction groups. Among the 1 182 cases, 941 of them (81.3%, 84.9%, and 84.0% inHFrEF, HFmrEF and HFpEF groups, respectively) were followed up for an median duration of 27.3 months. Results: (1) Among the study patients, 26.5% were in HFrEF, 24.3% in HFmrEF, and 49.2% in HFpEF groups. (2) Ischemic heart disease with HFmrEF was more frequent than that in patients with HFrEF. The average age, percentage of female subjects, systolic blood pressure, uric acid, N terminal B-type natriuretic peptide precursor (NT-proBNP), hemoglobin, and the incidence of hypertensive heart disease, anemia, atrial fibrillation in patients with HFmrEF were higher than those in patients with HFrEF, but lower than those in patients with HFpEF (all P<0.01). (3) The all-cause cumulative mortality was 10.8% at 1 year, 20.6% at 2 years and 35.9% at 5 years. No difference was observed in the all-cause cumulative mortality at 1 year, 2 years, 5 years among the three groups (all P>0.05). Conclusions: The HFmrEF patients, as a new and distinct group, were with many intermediate characteristics compared with HFrEF and HFpEF subjects. However, the all-cause mortality was not significantly different among HF patients with different LVEF.

Outcomes in Transcatheter Aortic Valve Replacement for Bicuspid Versus Tricuspid Aortic Valve Stenosis

BackgroundTranscatheter aortic valve replacement (TAVR) is being increasingly performed in patients with bicuspid aortic valve stenosis (AS). ObjectivesThis study sought to compare the procedural and clinical outcomes in patients with bicuspid versus tricuspid AS from the Bicuspid AS TAVR multicenter registry. MethodsOutcomes of 561 patients with bicuspid AS and 4,546 patients with tricuspid AS were compared after propensity score matching, assembling 546 pairs of patients with similar baseline characteristics. Procedural and clinical outcomes were recorded according to Valve Academic Research Consortium-2 criteria. ResultsCompared with patients with tricuspid AS, patients with bicuspid AS had more frequent conversion to surgery (2.0% vs. 0.2%; p = 0.006) and a significantly lower device success rate (85.3% vs. 91.4%; p = 0.002). Early-generation devices were implanted in 320 patients with bicuspid and 321 patients with tricuspid AS, whereas new-generation devices were implanted in 226 and 225 patients with bicuspid and tricuspid AS, respectively. Within the group receiving early-generation devices, bicuspid AS had more frequent aortic root injury (4.5% vs. 0.0%; p = 0.015) when receiving the balloon-expanding device, and moderate-to-severe paravalvular leak (19.4% vs. 10.5%; p = 0.02) when receiving the self-expanding device. Among patients with new-generation devices, however, procedural results were comparable across different prostheses. The cumulative all-cause mortality rates at 2 years were comparable between bicuspid and tricuspid AS (17.2% vs. 19.4%; p = 0.28). ConclusionsCompared with tricuspid AS, TAVR in bicuspid AS was associated with a similar prognosis, but lower device success rate. Procedural differences were observed in patients treated with the early-generation devices, whereas no differences were observed with the new-generation devices.

Abstract WP328: Mortality and Cause of Death Following Hospitalization for Acute Ischemic Stroke in California

Objectives: Understanding of the mortality and cause of death after ischemic stroke is important in helping hospitals targeting potential preventable and treatable medical conditions, and optimizing management strategies. The purpose of the study was to investigate California-specific mortality and cause of death following hospitalization for acute ischemic stroke based on patient demographic characteristics in a large patient population. Methods: Adult patients admitted to California-licensed acute care hospitals for acute ischemic stroke from 2013 to 2014 were included in the study. Data were from the California patient discharge data, linked to California death certificate records (2013 to 2014) using patient’ social security number as the common identifier. Mortality rates and causes of death based on patient gender, age, race, and expected payer were evaluated. Results: Of 73,982 patients, 20.8% (15,428) had died by the end of study period. Nearly half of these deaths occurred within 30 days of admission, and a quarter of deaths happened within 7 days. Female, age &gt;= 80, and white patients had a significant higher mortality rate. The cumulative all-cause mortality rate was 10.0% at 30 days, and 19.3% at 1 year. Over 70% of the patients died from diseases of the circulatory system, while stroke contributed to 43.4%. Deaths within 7 days were primarily caused by stroke as well as fibrillation and flutter. Female, age &gt;= 80, white and Medicare patients tended to die from diseases of the circulatory system while male, younger, black and Medi-Cal (California’s Medicaid program) patients were more likely died from cancer. Conclusion: Mortality and cause of death varied significantly by patient demographic characteristics. Effective interventions and preventions based on patient demography as well as better management of stroke and fibrillation &amp; flutter in first week may reduce the stroke mortality rates and improve hospital quality.

Rural older people had lower mortality after accidental falls than non-rural older people.

ObjectiveThis study aimed to investigate the mortality rate after falls of rural and non-rural older people and to explore the risk factors of mortality after falls among older people.Patients and methodsThis population-based case–control study identified two groups from a nationwide claim database (National Health Insurance Research Database in Taiwan): a rural group and a non-rural group, which included 3,897 and 5,541 older people, respectively, who were hospitalized for accidental falls (The International Classification of Diseases, Ninth Revision, Clinical Modification: E880–E888) during 2006–2009. Both groups were followed up for 4 years after falls. Four-year cumulative all-cause mortality rate after falls was calculated, and the demographic factor, comorbidity, and medications were considered as the potential risk factors of mortality after falls.ResultsThe rural group had a significantly higher frequency of fall-related hospitalizations (7.4% vs 4.3%, P<0.001), but a lower 4-year cumulative all-cause mortality rate after falls than the non-rural group (8.8% vs 23.4%, P<0.001). After adjusting for age, gender, comorbidity, and medication use, the rural group had a significantly lower risk of mortality after falls than the non-rural group (adjusted odds ratio =0.32, 95% confidence interval =0.28–0.37, P<0.001). Age, gender, place of residence, comorbidity, number of medications, and inappropriate medication use were independent risk factors of mortality after falls.ConclusionThe rural older people had a higher frequency of fall-related hospitalizations but lower mortality after falls than the non-rural older people. Fall prevention programs should be adjusted for difference in place of residence.