Reshaping bicuspid aortic valve stenosis with an hourglass-shaped balloon for transcatheter aortic valve replacement: A pilot study.

OBJECTIVES: We evaluated the safety and usefulness of preparatory anatomical reshaping with a geometric hourglass-shaped balloon to optimize transcatheter aortic valve replacement (TAVR) outcomes in bicuspid aortic valve (BAV) stenosis. BACKGROUND: TAVR has been increasingly performed for BAV stenosis; however, technical challenges remain. Procedural results are suboptimal given unfavorable valvular anatomies. METHODS: Eligible patients with BAV stenosis were enrolled to undergo aortic valve predilatation with the hourglass-shaped TAV8 balloon before TAVR using the self-expandable Venus A-Valve. Procedural details and outcomes were compared to a sequential group of patients with BAV who underwent TAVR with the same device following preparatory dilatation using a cylindrical balloon. RESULTS: A total of 22 patients were enrolled in the TAV8 group and 53 were included in the control group. Valve downsizing was less common in the TAV8 group (36.4 vs. 67.9%; p = .012). Stable valve release and optimal implant depth were consistently achieved in the TAV8 group with no requirement for a second valve (0 vs. 17.0%; p = .039) and with higher device success rates (100.0 vs 77.4%; p = .014). Residual aortic regurgitation graded as ≥mild was less common in the TAV8 group (13.6 vs 45.3%; p = .009). Mortality was similar (0 vs. 3.8%; p = 1); no major/disabling stroke or conversion to open-heart surgery was seen in either group within 30 days. CONCLUSIONS: Compared with standard cylindrical balloon valvuloplasty, preparatory reshaping with the hourglass-shaped balloon before self-expandable TAVR in BAV was associated with significantly better procedural results and may encourage more promising outcomes.

Permanent pacemaker implantation after transcatheter aortic valve replacement in bicuspid aortic valve patients.

BACKGROUND: Studies of permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) specifically for bicuspid aortic valve (BAV) patients are lacking. We aim to delineate possible aspects that might affect the incidence of PPI in a retrospective cohort of BAV patients treated with early-generation self-expanding devices. METHODS: A total of 80 patients with bicuspid morphology who successfully underwent TAVR by self-expanding devices without prior PPI were included. Baseline clinical, echocardiographic, and angiographic characteristics, procedural and post-procedural details were collected. RESULTS: The incidence of PPI after early-generation self-expanding valves in this BAV cohort was 26.3%. Baseline characteristics were comparable between patients requiring PPI post-TAVR or not. Perimeter oversizing greater than 20% significantly increased the risk of PPI compared with an oversizing of 10-20% (OR 5.08 [1.22, 21.07], P = 0.03). The proportion of patients with a depth of implantation greater than 6 mm was significantly higher in those who required PPI (82.4% vs 54.3%, P = 0.04). When testing the impact of depth of implantation >6 mm and oversizing in different morphologies, only in type 1 bicuspid patients and by oversizing>20% increased the risk of PPI (OR 12.00 [1.25, 115.36], P = 0.03) compared with an oversizing of 10-20%. CONCLUSIONS: Excessive perimeter oversizing in relation to aortic annulus and depth of implantation greater than 6 mm should be avoided to improve PPI post-TAVR for BAV patients receiving self-expanding devices, especially for type 1 BAV.

Transcatheter aortic valve implantation with the self-expandable venus A-Valve and CoreValve devices: Preliminary Experiences in China.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been demonstrated to be an effective alternative to surgical aortic valve replacement (SAVR) in patients with aortic stenosis who are deemed high risk or inoperable. Currently, TAVI procedures in China mostly make use of the domestic Venus A-Valve and the CoreValve; however, there is no data on their comparative performance. METHODS: Consecutive patients undergoing TAVI with the aforementioned devices were included. The outcomes were reported according to the Valve Academic Research Consortium-2 (VARC) definitions. RESULTS: A total of 54 TAVI procedures were performed, 27 with the CoreValve and the other 27 with the Venus A-Valve. An additional valve was required in 4 (14.8%) and 3 (11.1%) patients, and the VARC-2 device success rates were 81.5 and 85.2%, respectively. The incidences of common complications were similar, except for the significantly less frequent pacemaker insertion in the Venus A-Valve group (7.4 vs. 37.0%, P = 0.03). Within 30 days, 2 (3.7%) patients died, 1 in each group, and both had a bicuspid aortic valve (BAV). No other serious complications, such as annular rupture, coronary obstruction and aortic dissection, occurred in the 32 BAV patients treated with the Venus A-Valve (14) or the CoreValve (18). After 2-years of follow-up, there was no significant difference between CoreValve group and Venus-A group (11.1 vs. 7.4%, P = 0.64). CONCLUSION: TAVI with the domestic Venus A-Valve is feasible, safe, and can produce favorable short-term outcomes comparable to those with the CoreValve in inoperable or high-risk patients with tricuspid and bicuspid aortic valve stenosis. © 2017 Wiley Periodicals, Inc.

The relationship between chronic obstructive pulmonary disease and transcatheter aortic valve implantation--A systematic review and meta-analysis.

OBJECTIVE: The present study was performed to investigate the relationship between chronic obstructive pulmonary disease (COPD) and transcatheter aortic valve implantation (TAVI). BACKGROUND: Controversies regarding the relationship between COPD and TAVI have intensified. METHODS: A literature review of the PubMed online database was performed, and articles published between January 1, 2002 and March 20, 2015 were analyzed. Random-effect and fixed-effect models were used, depending on the between-study heterogeneity. RESULTS: A total of 28 studies, involving 51,530 patients, were identified in our review. The burden of COPD ranged from 12.5% to 43.4%, and COPD negatively impacted both short-term and long-term all-cause survival (30 days: odds ratio [OR], 1.43, 95% CI, 1.14-1.79; >2 years: hazard ratio [HR], 1.34, 95% CI, 1.12-1.61). COPD was also associated with increased short-term and mid-term cardiac-cause mortality (30 days: OR, 1.29, 95% CI, 1.02-1.64; 1 year: HR: 1.09, 1.02-1.17). Moreover, COPD (OR, 1.97, 95% CI, 1.29-3.0) predicted post-TAVI acute kidney disease. Importantly, chronic kidney disease (CKD) (HR, 1.2, 95% CI, 1.1-1.32) and the distance of the 6 minute walk test (6MWT) (HR, 1.16, 1.06-1.27) predicted TAVI futility in patients with COPD. CONCLUSION: COPD is common among patients undergoing TAVI, and COPD impacts both short- and long-term survival. COPD patients, who had a lower BMI, shorter distance of 6MWT and CKD, were at higher risk for TAVI futility.

A Predictive Study of the Dynamic Development of the P-Wave Terminal Force in Lead V1 in the Electrocardiogram in Relation to Long-Term Prognosis in Non-ST-Segment Elevation Acute Coronary Syndrome Patients during Hospitalization.

BACKGROUND: Changes in the ECG indicator PtfV1 reflect left atrial pressure and left ventricular diastolic function in NSTE-ACS patients during hospitalization. The value of PtfV1 in the evaluation of long-term prognosis in NSTE-ACS is still not clear. The purpose of this study was to investigate the relationship between the dynamic changes in P-wave terminal force in lead V1(PtfV1) in the ECG of non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients during hospitalization and the long-term major adverse cardiovascular events (MACEs) of patients. METHODS: A total of 595 patients who received coronary angiography and were confirmed as NSTE-ACS in the coronary heart disease database of Department of Cardiology of West China Hospital were continuously included. The PtfV1 and other clinical data at admission and discharge were collected and dynamically observed. The end events of follow-up observation were MACEs. RESULTS: Follow-up was performed on 595 patients for 24.71 ± 1.95 months. There were 127 PtfV1(+) and 468 PtfV1(-) at admission, and the incidences of MACEs were 14.2% and 11.1%, respectively (P = 0.731). Compared with patients with persistent PtfV1(-) ECG at admission and discharge, 53 patients with persistent PtfV1(+) ECG at admission and discharge had increased risk for MACEs (HR: 2.221, 95% CI: 1.072-4.601, P = 0.032); 94 patients with new PtfV1(+) ECG at discharge also had significantly increased risk for MACEs (HR: 2.993, 95% CI: 1.660-5.397, P = 0.000). CONCLUSIONS: NSTE-ACS patients with persistent PtfV1(+) ECG indicators at admission and discharge and new PtfV1(+) at discharge had significantly increased risk of MACEs.

The effect of folate fortification on folic acid-based homocysteine-lowering intervention and stroke risk: a meta-analysis.

OBJECTIVE: Folate and vitamin B12 are two vital regulators in the metabolic process of homocysteine, which is a risk factor of atherothrombotic events. Low folate intake or low plasma folate concentration is associated with increased stroke risk. Previous randomized controlled trials presented discordant findings in the effect of folic acid supplementation-based homocysteine lowering on stroke risk. The aim of the present review was to perform a meta-analysis of relevant randomized controlled trials to check the how different folate fortification status might affect the effects of folic acid supplementation in lowering homocysteine and reducing stroke risk. DESIGN: Relevant randomized controlled trials were identified through formal literature search. Homocysteine reduction was compared in subgroups stratified by folate fortification status. Relative risks with 95 % confidence intervals were used as a measure to assess the association between folic acid supplementation and stroke risk. SETTING: The meta-analysis included fourteen randomized controlled trials, SUBJECTS: A total of 39 420 patients. RESULTS: Homocysteine reductions were 26·99 (sd 1·91) %, 18·38 (sd 3·82) % and 21·30 (sd 1·98) %, respectively, in the subgroups without folate fortification, with folate fortification and with partial folate fortification. Significant difference was observed between the subgroups with folate fortification and without folate fortification (P=0·05). The relative risk of stroke was 0·88 (95 % CI 0·77, 1·00, P=0·05) in the subgroup without folate fortification, 0·94 (95 % CI 0·58, 1·54, P=0·82) in the subgroup with folate fortification and 0·91 (95 % CI 0·82, 1·01, P=0·09) in the subgroup with partial folate fortification. CONCLUSIONS: Folic acid supplementation might have a modest benefit on stroke prevention in regions without folate fortification.

The value of combining CYP2C19*2 polymorphism with classic risk factors in prediction of clinical prognosis in acute coronary syndrome patients.

OBJECTIVES: To assess the impact of different CYP2C19*2 polymorphisms on clinical outcomes and the effects of CYP2C19*2 polymorphism on predicting clinical outcomes in association with classic risk factors in patients with acute coronary syndromes (ACS). METHODS: Between July 2008 and September 2009, 497 consecutive patients with ACS who were admitted to the West China Hospital of Sichuan University were enrolled and underwent CYP2C19*2 determination. The clinical outcomes were the composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke. RESULTS: Baseline characteristics were balanced between noncarrier, heterozygous and homozygous groups of the CYP2C19*2 variant. The clinical endpoint occurred more frequently in the homozygous group (HR 4.86, CI 1.62-14.56, p = 0.005). After multivariable analysis, the CYP2C19*2 genetic variant was an independent predictor of cardiovascular events (HR 5.96, CI 1.77-20.03, p = 0.0039) as well as GRACE score and Killip class. The combination of CYP2C19*2 with GRACE score and Killip class increases the potential to predict adverse outcomes. CONCLUSIONS: Homozygosity (A/A) for CYP2C19*2 mutant is an independent determinant of prognosis in patients with ACS. The combination of CYP2C19*2 polymorphism with classic risk factors may be a useful tool to predict the risk of cardiovascular events.

Hypertension is a risk factor for adverse outcomes in patients with coronavirus disease 2019: a cohort study.

BACKGROUND: Comorbidities are commonly seen in patients with coronavirus disease 2019 (COVID-19), but the clinical implication is not yet well-delineated. We aim to characterize the prevalence and clinical implications of comorbidities in patients with COVID-19. METHODS: This is a retrospective multi-centre study involving patients admitted between January 16th and March 10th 2020. The composite endpoint was defined as the presence of at least one of the following, intensive care unit (ICU) admission, or the need for mechanical ventilation, or death. RESULTS: A total of 472 consecutive cases admitted to 51 certified COVID-19 tertiary care hospitals were enrolled (median age was 43 [32-53.5] years and 53.0% were male). There were 101 (21.4%) patients presented with comorbidities, including hypertension (15.0%), diabetes mellitus (7.8%), coronary artery disease (2.6%), chronic obstructive pulmonary disease (1.3%) and cerebrovascular disease (1.9%). The composite endpoint occurred in 65 (13.8%) patients. Multivariate stepwise logistic regression analysis indicated that older age (odds ratio [OR] 1.39, 95% confidence interval (CI) 1.05-1.85, per 10-year increment), antecedent hypertension (OR 2.82, 95% CI 1.09-7.29), neutrophil counts (OR 1.33, 95% CI 1.14-1.56) and lactate dehydrogenase level (OR 1.01, 95% CI 1.00-1.01) were independently associated with the presence of composite endpoint. Hypertensive patients, compared with controls, had a greater chance of experiencing the composite endpoint (p < .001) and each individual endpoint, i.e. ICU admission (p < .001), mechanical ventilation (p < .001) and death (p = .012). In the stepwise regression analysis of anti-hypertensive medications, none of the therapy predicted the composite endpoint. CONCLUSIONS: Hypertension is a common comorbidity in patients with COVID-19 and associated with adverse outcomes. KEY MESSAGES Hypertension was identified as the comorbidity associated with the prognosis of COVID-19 in this retrospective cohort. Patients with hypertension could experience an increased risk of the composite endpoint. Anti-hypertensive therapy did not affect patient outcomes.

Acute myocardial injury is common in patients with COVID-19 and impairs their prognosis.

OBJECTIVE: We sought to explore the prevalence and immediate clinical implications of acute myocardial injury in a cohort of patients with COVID-19 in a region of China where medical resources are less stressed than in Wuhan (the epicentre of the pandemic). METHODS: We prospectively assessed the medical records, laboratory results, chest CT images and use of medication in a cohort of patients presenting to two designated covid-19 treatment centres in Sichuan, China. Outcomes of interest included death, admission to an intensive care unit (ICU), need for mechanical ventilation, treatment with vasoactive agents and classification of disease severity. Acute myocardial injury was defined by a value of high-sensitivity troponin T (hs-TnT) greater than the normal upper limit. RESULTS: A total of 101 cases were enrolled from January to 10 March 2020 (average age 49 years, IQR 34-62 years). Acute myocardial injury was present in 15.8% of patients, nearly half of whom had a hs-TnT value fivefold greater than the normal upper limit. Patients with acute myocardial injury were older, with a higher prevalence of pre-existing cardiovascular disease and more likely to require ICU admission (62.5% vs 24.7%, p=0.003), mechanical ventilation (43.5% vs 4.7%, p<0.001) and treatment with vasoactive agents (31.2% vs 0%, p<0.001). Log hs-TnT was associated with disease severity (OR 6.63, 95% CI 2.24 to 19.65), and all of the three deaths occurred in patients with acute myocardial injury. CONCLUSION: Acute myocardial injury is common in patients with COVID-19 and is associated with adverse prognosis.

Understanding the Interaction Between Transcatheter Aortic Valve Prostheses and Supra-Annular Structures From Post-Implant Stent Geometry.

OBJECTIVES: The authors sought to better understand the stent geometry of the Lotus valve after transcatheter aortic valve replacement (TAVR) and its potential implications for valve size selection. BACKGROUND: The authors hypothesized that the greatest interference between the frame and aortic valvar complex occurs across the aortic valve leaflets. METHODS: The authors retrospectively analyzed the multidetector computed tomography (MDCT) scans of 32 consecutive patients undergoing Lotus valve (Boston Scientific, Natick, Massachusetts) implantation. The prosthesis cross section was analyzed at 3-mm increments along its length. The plane where the frame had the smallest area was defined as the waist. The corresponding plane of the waist on pre-procedural MDCT was identified by surrounding structures such as calcium deposits, commissural fusion, and commissural gaps, and was referred to as the supra-annulus. The spline of the supra-annulus was circumscribed with reference to the post-implant stent geometry at the waist. RESULTS: The waist was 5.8 ± 1.7 mm higher than the native annulus on post-procedural MDCT. The waist had a nearly 2-fold larger compression rate than the stent at the native annulus level (36.3 ± 10.4% vs. 18.9 ± 9.6%; p < 0.01), irrespective of valve morphologies. The supra-annulus was 5.9 ± 1.6 mm higher than the annulus on pre-procedural MDCT. Patients had an approximately 17% decrease in area from the annulus to the supra-annulus (18.3 ± 4.4% for bicuspid morphology and 16.0 ± 3.5% for tricuspid morphology). CONCLUSIONS: Major interference between the implanted prosthesis and anatomy occurred at a level above the annulus. The decrease in area from the annulus to supra-annulus may explain the feasibility of implanting a smaller valve than that suggested by traditional annular measurements.

Transcatheter aortic valve replacement in patients with non-calcific aortic stenosis.

AIMS: Limited information exists describing the results of transcatheter aortic valve replacement (TAVR) in patients with symptomatic severe non-calcific aortic stenosis (AS). We aimed to compare procedural, echocardiographic, and clinical outcomes among patients with non-calcific AS with those of senile calcific AS undergoing TAVR. METHODS AND RESULTS: We retrospectively identified patients with non-calcific AS who received TAVR with self-expanding transcatheter heart valves in our centre. Clinical and echocardiographic outcomes, and post-procedural multi-detector computed tomography (MDCT) measures were compared to those in patients undergoing TAVR for calcific AS. Among 136 patients, 21 patients (15.4%) with native leaflet thickening and minimal calcification were identified (non-calcific group). The patients were significantly younger in the non-calcific group (70.0 [64.0-75.5] vs. 75.0 [69.0-78.0] years) with comparable STS-PROM scores (6.7 [4.8-8.9] vs. 8.2 [4.8-10.9] %). Predilation was performed less frequently (42.9% vs. 93.9%) and post-dilation more often (71.4% vs. 42.6%) in the non-calcific group. Both 30-day and one-year mortality were similar between groups (0% vs. 7.8% and 0% vs. 17.6%). Rates of post-implantation paravalvular leak ≥mild at six months (17.6% vs. 25.7%) were comparable despite lower implantation depth among non-calcific AS patients (10.9±5.7 vs. 7.2±4.3 mm) on post-implantation MDCT. CONCLUSIONS: TAVR with self-expanding transcatheter heart valves appears to be safe and effective in patients with non-calcific AS.

Comparison of procedural, clinical and valve performance results of transcatheter aortic valve replacement in patients with bicuspid versus tricuspid aortic stenosis.

BACKGROUND: Limited date describing the procedural, clinical and valve performance results of transcatheter aortic valve replacement (TAVR) in patients with bicuspid versus tricuspid aortic stenosis (TAV). METHODS: Procedural and clinical results were defined and reported according to VARC-2 criteria. RESULTS: Consecutive 87 patients with BAV and 70 patients with TAV were included. Compared to patients with TAV, patients with BAV had similar incidence of second valve implantation (14.9% vs 12.9%, p=0.708), more than mild paravalvular leakage (PVL, 40.2% vs 31.9%, p=0.288), permanent pacemaker implantation (PPM, 24.1% vs 28.6%, p=0.53). Furthermore, the procedural and clinical results of TAVR also did not differ between patients with type 0 and type 1 (second valve implantation: 18.4% vs 11.8%, p=0.71, PVL: 38.8% vs 41.2%, p=0.83, PPM: 18.4% vs 31.6%, p=0.16). The hemodynamic outcomes were similar in patients with BAV and TAV at 1-year (maximum velocity, 2.3 vs 2.2m/s, p=0.307) and 2-year (2.3 vs 2.1m/s, p=0.184) follow-up respectively. Adjusted binary logistic regression analysis found oversizing ratio at 14.45-20.57% is at lower risk for more than mild PVL (OR, 0.069, 95% CI, 0.011-0.428, p=0.004). Moreover, the Kaplan-Meier survival analysis revealed that TAVR in type 0 BAV, type 1 BAV and TAV have comparable risk for midterm mortality (Log rank, p=0.772). CONCLUSION: TAVR in whatever type of BAV appeared to be safe and efficacy, and TAVR in BAV was associated with comparable bioprosthetic function during follow up compared to patients with TAV.

Less pronounced reverse left ventricular remodeling in patients with bicuspid aortic stenosis treated with transcatheter aortic valve replacement compared to tricuspid aortic stenosis.

To compare reverse left ventricular (LV) remodeling after transcatheter aortic valve replacement (TAVR) between patients with bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV). We retrospectively reviewed data of patients with at least two serial echocardiographic follow-ups (1, 3, 6 months and 1 year) post-TAVR. A total of 116 patients were identified. BAV morphology was documented in 67 patients. LV mass index (LVMi) at baseline was not significantly different between the TAV and BAV group (178.0 ± 6.9 vs. 166.3 ± 6.4 g/m2, P = 0.14). Reverse LV remodeling was observed in both BAV and TAV patients, but the reduction of LVMi from baseline was significantly more pronounced in TAV patients compared with BAV patients from 6 months post-TAVR (- 56.3 ± 8.1 vs. - 30.0 ± 4.7 g/m2, P < 0.01 at 6-month follow-up; - 60.6 ± 7.6 vs. - 37.9 ± 6.2 g/m2, P = 0.02 at 1-year follow-up). EDV value changes during follow-up were similar between patient with TAV and BAV. There were no significant differences in the proportions of patients with more than mild PVL or new permanent pacemaker between TAV and BAV morphology throughout the follow-up. Patients with bicuspid morphology might experience less pronounced reverse LV remodeling post-TAVR than patients with tricuspid morphology.

Hemodynamic changes after transcatheter aortic valve implantation during sequential follow-ups in patients with bicuspid aortic valve compared with tricuspid aortic valve.

BACKGROUND: To investigate the individual sequential hemodynamic changes after transcatheter aortic valve implantation (TAVI), especially for patients with bicuspid aortic valve (BAV), in comparison with tricuspid aortic valve (TAV). METHODS: The study population comprised 85 patients with severe aortic stenosis who underwent TAVI for BAV (n = 49) or TAV (n = 36) with at least two serial echocardiographic follow-ups. Doppler echocardiography was scheduled to be performed at discharge and 1, 3, 6 months and 1 year after the procedure. D peak transvalvular velocities and D mean transvalvular gradients were calculated as the difference at follow-up time points and discharge. Paravalvular leak (PVL) was assessed as another indicator for prosthesis performance. RESULTS: Comparisons between patients with BAV and TAV revealed similar gradient performances (1.00 [-2.00, 2.00] vs. 1.00 [-0.25, 5.00] mm Hg, p = 0.57 at 1 month; -0.71 ± 7.52 vs. 1.55 ± 3.97 mm Hg, p = 0.21 at 3 months; 0.96 ± 7.81 vs. 1.53 ± 5.85 mm Hg, p = 0.79 at 6 months; 1.00 [-0.50, 2.25] vs. 3.00 [-0.50, 7.50] mm Hg, p = 0.07 at 1 year). Moreover, the incidence of ≥ mild PVL was not significantly different in patients with BAV and TAV during follow-up (34.88% vs. 19.35%, p = 0.14 at 1 month; 45.83% vs. 27.27%, p = 0.19 at 3 months; 30.00% vs. 23.53%, p = 0.89 at 6 months; 30.00% vs. 17.65%, p = 0.56 at 1 year). CONCLUSIONS: TAVI is effective and applicable in BAV anatomy with sustained and acceptable mid- -term prosthesis hemodynamic performance. (Cardiol J 2017; 24, 4: 350-357).

Incidence, Predictors and Outcome of Prosthesis-Patient Mismatch after Transcatheter Aortic Valve Replacement: a Systematic Review and Meta-analysis.

The aim of this study was to investigate the incidence, predictors and outcome of prosthesis-patient mismatch (PPM) following transcatheter aortic valve replacement (TAVR). A total of 30 articles incorporating 4,691 patients were identified. The pooled incidences of overall, moderate and severe PPM following TAVR were 33.0%, 25.0% and 11.0% respectively. Medtronic CoreValve (MCV) had lower incidence of overall (32% vs: 40%, P < 0.0001) and moderate (23% vs 32%, P < 0.0001) than Edwards Sapien (ESV). PPM was associated with a younger age, smaller annulus diameter and lower left ventricular ejection fraction in comparison with those patients without PPM. Post-dilation (OR, 0.51, 95% CI, 0.38 to 0.68, p < 0.001) during TAVR would decrease the incidence of PPM. Although PPM was common after TAVR, no significant differences were observed both in short- and mid-term all-cause mortality (30 day: OR: 1.1, 95% CI, 0.70 to 1.73 and 2 year: OR: 1.01, 95% CI, 0.74 to 1.38) between patients with PPM and those without PPM. In conclusion, despite being common after TAVR, the incidence of PPM was lower than that of surgical aortic valve replacement (SAVR) and decreased with the experience accumulating, and PPM was not seen to impact on short- and mid-term survival, regardless of its magnitude.

Predictors and outcome of acute kidney injury after transcatheter aortic valve implantation: a systematic review and meta-analysis.

AIMS: The aim of this systematic review and meta-analysis was to investigate the predictors and outcome of acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: There were 35 articles recruiting 13,256 patients included in our study. Hypertension (odds ratio [OR] 1.92, 95% CI: 1.44 to 2.56), diabetes mellitus (OR 1.33, 95% CI: 1.20 to 1.47), peripheral artery disease (OR 1.28, 95% CI: 1.14 to 1.45) and a left ventricular ejection fraction <40% (OR 1.50, 95% CI: 1.19 to 1.88) were identified as significant independent predictors of AKI. In addition to the aforementioned comorbidities, procedure-related/post-TAVI factors such as transapical access (OR 1.68, 95% CI: 1.44 to 1.97), major bleeding (OR 1.82, 95% CI: 1.37 to 2.40) and transfusion (OR 1.30, 95% CI: 1.12 to 1.51) were also associated with a higher risk of AKI. Importantly, the risk of short-term all-cause death increased progressively with the aggravating severity of AKI (OR, 30 days: stage 1: 3.41; stage 2: 4.0; stage 3: 11.02; one year: stage 1: 1.95; stage 2: 2.82; stage 3: 7.34), as determined by a univariate analysis. After eliminating confounders, AKI remained linked to a higher risk for both short-term (30 days: HR 2.12, 95% CI: 1.59 to 2.83) and long-term (≥3 years: HR 1.37, 95% CI: 1.27 to 1.48) all-cause mortality. CONCLUSIONS: The reason for the occurrence of AKI was multifactorial, including baseline characteristics, procedure-related and post-TAVI factors. It appeared that even stage 1 AKI exerted detrimental effects on survival within one year, and AKI was also independently linked to mortality beyond three years.

Meta-Analysis of the Effectiveness and Safety of Transcatheter Aortic Valve Implantation Without Balloon Predilation.

Evidence regarding the safety and feasibility of transcatheter aortic valve implantation without balloon predilation (BP) is scarce. A literature search of PubMed, EMBASE, CENTRAL, and major conference proceedings was performed from January 2002 to July 2015. There were 18 studies incorporating 2,443 patients included in the present study. No differences were observed in the baseline characteristics between patients without BP (no-BP) and with BP. Compared with BP, no-BP had a shorter procedure time (no-BP vs BP, 124.2 vs 138.8 minutes, p = 0.008), used less-contrast medium (no-BP vs BP, 126.3 vs 156.3 ml, p = 0.0005) and had a higher success rate (odds ratio [OR] 2.24, 95% CI 1.40 to -3.58). In addition, no-BP was associated with lower incidences of permanent pacemaker implantation (OR 0.45, 95% CI 0.3 to 0.67), grade 2 or greater paravalvular leakage (OR 0.55, 95% CI 0.37 to 0.83), and stroke (OR 0.57, 95% CI 0.32 to 1.0). Furthermore, no-BP was associated with a 0.6-fold decreased risk for 30-day all-cause mortality (OR 0.60, 95% CI 0.39 to 0.92). However, the difference in the risk for permanent pacemaker implantation, grade 2, or higher aortic regurgitation, stroke was noted to be significant only in the subgroup of the CoreValve-dominating studies. In conclusion, no-BP before transcatheter aortic valve implantation was not only safe and feasible but was also associated with fewer complications and short-term mortality in selected patients especially using self-expandable valve.

Admission Serum Calcium Levels Improve the GRACE Risk Score Prediction of Hospital Mortality in Patients With Acute Coronary Syndrome.

BACKGROUND: The Global Registry of Acute Coronary Events (GRACE) risk score has been extensively validated to predict risk during hospitalization in patients with acute coronary syndrome (ACS). Recently, serum calcium has been suggested as an independent predictor for in-hospital mortality in patients with ST-segment elevation myocardial infarction; however, the relationship between the 2 has not been evaluated. HYPOTHESIS: The combination of GRACE risk score and serum calcium could provide better performance in risk prediction. METHODS: The study enrolled 2229 consecutive patients with ACS. Independent predictors were identified by a multivariate logistic regression model. The incremental prognostic value added by serum calcium to the GRACE score was evaluated by receiver operating characteristic, net reclassification improvement (NRI), and integrated discrimination improvement (IDI). RESULTS: Patients in the upper quartiles of serum calcium presented with lower in-hospital mortality (odds ratios for 3 upper quartiles vs lowest quartile, respectively: 0.443, 95% confidence interval [CI]: 0.206-0.953; 0.243, 95% CI: 0.090-0.654; and 0.210, 95% CI: 0.082-0.538). Area under the curve increased significantly after adding serum calcium to the GRACE score (0.685 vs 0.746; Z = 2.617, P = 0.009). Furthermore, inclusion of serum calcium in the GRACE score enhanced NRI (0.524; P = 0.009) and IDI (0.011; P = 0.003). CONCLUSIONS: Lower serum calcium level on admission is a possible indicator of increased risk of in-hospital mortality in ACS patients. Inclusion of serum calcium in the GRACE score may lead to a more accurate prediction of this risk. Large prospective studies are needed to confirm this finding.