Value of prognostic nutritional index for survival prediction in trans-catheter aortic valve replacement compared to other common nutritional indexes.

BACKGROUND: Nutritional status predicts outcomes after TAVR. Predictive value of Prognostic Nutritional Index (PNI) was investigated in patients undergoing TAVR, and compared to other nutritional indexes. METHODS: A cohort of 114 patients undergoing TAVR in a high-volume centre was studied. A prospective 1-year follow-up was completed. PNI was estimated as follows: (10 × serum albumin[g/dl])+(0.005 × total lymphocytes [1000/µl]). One-year survival was compared in patients with PNI above vs below median; Kaplan-Meier curves were created. A multivariate analysis was used to assess predictive value of PNI for 1-year mortality. ROC curves were used to assess discrimination by PNI, and to compare it with Geriatric Nutritional Risk Index (GNRI) and Body Mass Index (BMI). RESULTS: Mean age was 82.2 years, 59.6% were male. Mean PNI was 46 ± 5. Pre-procedurally, no differences were found between patients with high vs. low PNI. One-year mortality was significantly higher in patients with low PNI values (19/57 vs. 4/57; p < .001). Complications did not differ. A higher PNI predicted 1-year survival, even after adjusting for clinical factors (model 1: HR 0.8, 95% CI 0.7-0.9, p < .0001) and laboratory parameters (NT-proBNP, IL-6, CRP, eGFR, cystatin C, haemoglobin) (model 2: HR 0.8, 95% CI 0.7-0.9, p < .05). ROC curves revealed a stronger predictive value for PNI (AUC 0.80) compared to GNRI (0.77) and BMI (0.6). The optimal cut-off for PNI was 45. CONCLUSION: PNI is a useful and practical nutritional marker reflecting malnutrition and inflammation prior to the intervention, and strongly predicts 1-year survival. PNI seems to be a better prognostic marker than BMI or GNRI after TAVR.

Potential Role and Prognostic Value of Erythropoietin Levels in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement.

Background: Both EPO levels and anemia have shown prognostic value in several cardiac disorders. An observational study with a prospective follow-up was performed to investigate their independent prognostic roles in severe aortic stenosis. Methods: An up to 36-month follow-up of consecutive patients with severe aortic stenosis undergoing TAVR in a high-volume center was performed. Patients with eGRF <30 mL/min/1.73 m2 were excluded. EPO levels and/or anemia status and its association with mid-term mortality were assessed. Results: Out of 407, 360 met eligibility criteria. Median age was 83 years, with 71.4% having a NYHA class III/IV. Anemia was present in 51.9%, and iron deficiency in 52.8%. Median (IQR) EPO levels were 14.4 (9.30-24.30) mIU/mL. Median follow-up was 566 days. Anemia was associated with overall mortality (HR 2.40, 95% CI 1.51-3.80, p < 0.001). Higher logEPO levels were associated with mid-term mortality (HR 4.05, 95% CI 2.29-7.16, p < 0.001), even after adjusting for clinically and/or statistically relevant factors (multivariate HR 2.25, 95 CI 1.09-4.66, p = 0.029). Kaplan-Meier analyses showed early diverging curves for anemia vs. non-anemia, whereas curves for patients in various EPO level quartiles started to diverge at about 100 days, with differences consistently increasing during the subsequent entire follow-up period. Conclusions: Differently from anemia, which was a strong predictor for both early and late mortality in severe aortic stenosis after TAVR, independent prognostic value of EPO only emerged after post-TAVR recovery. EPO prognostic value was independent from anemia and mild-to-moderate renal dysfunction. High EPO levels could be useful to identify patients with severe aortic stenosis showing a compromised mid-term survival in spite of TAVR use and independently from early TAVR results.

Hemodynamic Outcome and Valve Durability Beyond Five Years After Transcatheter Aortic Valve Replacement.

OBJECTIVE: The aim of this study was to evaluate hemodynamic outcome, structural valve deterioration, and bioprosthetic valve failure beyond 5 years after transcatheter aortic valve replacement (TAVR). METHODS: Demographic, procedural, and outcome data were obtained from all patients treated with TAVR at our institution from 2006 to 2012. We included all patients with echocardiographic data at baseline and with a follow-up echocardiography more than 5 years after TAVR. Standardized definitions were used to assess durability of transcatheter aortic valves. RESULTS: A total of 452 patients were treated with apical or transfemoral transcatheter aortic valve implantation (TAVI) from 2006-2012, and 103 (23%) patients were still alive more than 5 years post TAVI. Mean duration of follow-up was 7.0 ± 0.9 years, with a maximum duration of 9.8 years. Seventy-nine of the 103 patients (76.7%) underwent follow-up echocardiography. Mean aortic gradient decreased from 51.8 ± 14.3 mm Hg before TAVR to 11.7 ± 5.8 mm Hg after TAVR (P<.001), and remained stable at 10.6 ± 6.3 mm Hg during late follow-up (P=.26). Bioprosthetic valve failure occurred in 3 patients (3.8%); two of these patients required reintervention. Seven patients (8.9%) had moderate structural valve deterioration, and 1 patient (1.3%) had severe structural valve deterioration. CONCLUSION: TAVR with self-expanding and balloon-expandable valves appears to be a long-lasting treatment strategy for severe aortic stenosis with excellent long-term hemodynamic function and very low incidence of structural valve deterioration and bioprosthetic valve failure.

Short-term decrease of left atrial size predicts clinical outcome in patients with severe aortic stenosis undergoing TAVR.

OBJECTIVES: We investigated whether transcatheter aortic valve replacement (TAVR) results in a short-term decrease in left atrium (LA) size and whether such decrease may predict patients' clinical outcome. BACKGROUND: Increased LA size is a hallmark of severe aortic stenosis (AS) and is associated with adverse patients' cardiovascular outcome. Whether TAVR may lead to a decrease in LA size is not known. METHODS AND RESULTS: Hundred and four patients with severe symptomatic AS and dilated LA undergoing TAVR were enrolled. LA volume was assessed by echocardiography before and shortly after TAVR (median time: 7 days). Composite rate of death and hospitalization for acutely decompensated heart failure (HF) was recorded and clinical status was assessed through NYHA-class evaluation at 12 months median follow-up. After TAVR, 49 patients (47%) demonstrated a decrease in LA volume. Despite a similar baseline NYHA class, patients with decrease in LA size had significant better improvement in clinical status respect to patients with unvaried LA size (NYHA post: 1.2 ± 0.6 vs. 1.8 ± 1.1, p = .001; NYHA reduction: -1.6 ± 0.9 vs. -0.9 ± 1.0, p = .002, respectively). Moreover, these patients had a significantly reduced rate of death or HF-hospitalization (4 vs. 29%, p = .001) and a significantly longer event-free-survival from Kaplan-Meier curves (p = .003). COX regression analysis showed that, among echocardiographic parameters, decrease in LA size was an independent predictor of clinical outcome (HR: 0.149, CI: 0.034-0.654, p = .012). CONCLUSIONS: The lack of decrease in LA size shortly after TAVR is associated with significantly higher rates of death and HF-hospitalization, as well as with impaired improvement in clinical status during long-term follow-up.

Life beyond 5 Years after TAVI: Patients' Perceived Health Status and Long-Term Outcome after Transcatheter Aortic Valve Implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is currently recommended for patients with severe aortic stenosis at intermediate or high surgical risk. The decision process during TAVI evaluation includes a thorough benefit-risk assessment, and knowledge about long-term benefits and outcomes may improve patients' expectation management. OBJECTIVE: To evaluate patients' perceived health status and self-reported long-term outcome more than 5 years after TAVI. METHODS AND RESULTS: Demographic and procedure data were obtained from all patients treated with TAVI at our institution from 2006 to 2012. A cross-sectional survey was conducted on the patients alive, measuring health status, including the EQ-5D-5L questionnaire, and clinical outcomes. 103 patients (22.8%) were alive at a median follow-up period of 7 years (5.4-9.8). 99 (96%) of the 103 patients were included in the final analysis. The mean age at follow-up was 86.5 years ± 8.0 years, and 56.6% were female. Almost all patients (93.9%) described an improvement of their quality of life after receiving TAVI. At late follow-up, the mean utility index and EQ-VAS score were 0.80 ± 0.20 and 58.49 ± 11.49, respectively. Mobility was found to be the most frequently reported limitation (85.4%), while anxiety/depression was the least frequently reported limitation (19.8%). With respect to functional class, 64.7% were in New York Heart Association (NYHA) class III or IV, compared to 67.0% prior to TAVI (p=0.51). Self-reported long-term outcomes revealed mainly low long-term complication rates. 74 total hospitalizations were reported after TAVI, and among those 43% for cardiovascular reasons. Within cardiovascular rehospitalizations, new pacemaker implantations were the most frequently reported (18.9%), followed by cardiac decompensation and coronary heart disease (15.6%). CONCLUSION: The majority of the patients described an improvement of health status after TAVI. More than five years after TAVI, the patients' perceived health status was satisfactory, and the incidence of clinical events and hospitalizations was very low.

Gender-specific associations between coronary heart disease and other chronic diseases: cross-sectional evaluation of national survey data from adult residents of Germany.

BACKGROUND: Combinations of coronary heart disease (CHD) and other chronic conditions complicate clinical management and increase healthcare costs. The aim of this study was to evaluate gender-specific relationships between CHD and other comorbidities. METHODS: We analyzed data from the German Health Interview and Examination Survey (DEGS1), a national survey of 8152 adults aged 18-79 years. Female and male participants with self-reported CHD were compared for 23 chronic medical conditions. Regression models were applied to determine potential associations between CHD and these 23 conditions. RESULTS: The prevalence of CHD was 9% (547 participants): 34% (185) were female CHD participants and 66% (362) male. In women, CHD was associated with hypertension (OR = 3.28 (1.81-5.9)), lipid disorders (OR = 2.40 (1.50-3.83)), diabetes mellitus (OR = 2.08 (1.24-3.50)), kidney disease (OR = 2.66 (1.101-6.99)), thyroid disease (OR = 1.81 (1.18-2.79)), gout/high uric acid levels (OR = 2.08 (1.22-3.56)) and osteoporosis (OR = 1.69 (1.01-2.84)). In men, CHD patients were more likely to have hypertension (OR = 2.80 (1.94-4.04)), diabetes mellitus (OR = 1.87 (1.29-2.71)), lipid disorder (OR = 1.82 (1.34-2.47)), and chronic kidney disease (OR = 3.28 (1.81-5.9)). CONCLUSION: Our analysis revealed two sets of chronic conditions associated with CHD. The first set occurred in both women and men, and comprised known risk factors: hypertension, lipid disorders, kidney disease, and diabetes mellitus. The second set appeared unique to women: thyroid disease, osteoporosis, and gout/high uric acid. Identification of shared and unique gender-related associations between CHD and other conditions provides potential to tailor screening, preventive, and therapeutic options.

Cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation: a meta-analysis of randomized controlled trials.

OBJECTIVE: The aim of this study was to evaluate the clinical efficacy and safety outcomes of the treatment with cryoballoon (CB) compared to the treatment with traditional irrigated radiofrequency ablation (RF) for pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (pAF) and refractory to antiarrhythmic drug therapy (AAD). DESIGN: We conducted a systemic review to find and include more than two randomized controlled trials (RCTs) with at least 20 patients in each of the CB and RF groups. Thereafter, we performed a meta-analysis to compare the treatment with CB and RF in primary outcomes including 1 year free from AF, complications and re-ablation procedures. Additionally, we evaluated procedure time and fluoroscopy duration in both groups. Risk of bias in the individual studies and across studies was assessed using Cochrane methods. DATA EXTRACTION AND SYNTHESIS: Two reviewers extracted study data and assessed risk of bias. Primary outcome data were extracted from the time point 1 year after the procedure. The random-effects model was used to calculate the odds ratio with 95% confidence interval. DATA SOURCES: Data sources utilized were PubMed and CENTRAL databases up to 16 June 2016. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Included studies were RCTs in adults with pAF and refractory to AAD in which CB therapy, including 1st and 2nd generation CB, was compared to the traditional irrigated RF therapy. Clinical outcomes assessed in each RCT were 1 year AF-free survival, complication rates, re-ablations, fluoroscopy time and procedure time. RESULTS: The systematic review identified four randomized controlled trials that reported on comparative clinical outcomes involving 1284 patients. Our meta-analysis demonstrated that CB ablation had a non-significant higher success rate than RF therapy (OR 1.13; 95% CI 0.72-1.77). However, our study showed a relatively higher rate of complications in the CB group (OR 1.20; 95% CI 0.58-2.52). Furthermore, CB treatment was associated with a non-significant, shorter procedure time and marginally prolonged fluoroscopy time in comparison to RF treatment. CONCLUSION: Our systemic review and meta-analysis revealed further evidence that cryoballoon ablation is an equally effective alternative procedure to the standard radiofrequency treatment with a slightly, non-significant higher freedom from AF 1 year after the ablation and a shorter procedure time.

A Cost-Utility Analysis of Cryoballoon Ablation versus Radiofrequency Ablation for Paroxysmal Atrial Fibrillation.

INTRODUCTION: The objective of this study was to evaluate the cost-effectiveness of the treatment with cryoballoon (CB) compared to the standard treatment with traditional irrigated radiofrequency (RF) ablation for pulmonary vein isolation in patients with paroxysmal atrial fibrillation (pAF) refractory to antiarrhythmic drug therapy. METHODS: A decision tree model was developed to graphically depict the probabilities, utilities and costs of CB compared to RF therapy. Data from a conducted systematic literature review and meta-analysis of only RCTs were used to evaluate clinical outcomes of CB and RF treatments, including success rates after one year, complications and recurrence of atrial fibrillation. RESULTS: The cost-utility analysis estimated that, CB therapy had £1,747 higher cost, and 0.0114 more quality-adjusted life years (QALYs) compared to standard RF treatment over a one-year time horizon. The incremental cost per QALY of CB ablation compared to RF ablation was estimated to be £152,836/QALY. CONCLUSIONS: Based on current evidence, CB ablation for pulmonary vein isolation in patients with pAF is costeffective compared to RF if decision makers are willing to pay £152,836 or higher for a QALY.

First experience with the new generation Edwards Sapien 3 aortic bioprosthesis: procedural results and short term outcome.

BACKGROUND: TAVR has become an established treatment for severe symptomatic aortic stenosis in patients with high surgical risk. The latest generation of the balloon-expandable Edwards Sapien device, the Sapien 3, together with its new transfemoral Commander delivery system has been designed to reduce paravalvular regurgitation and vascular access site complications. OBJECTIVES: To evaluate procedural results and short term outcome with the third generation Sapien 3 device. METHODS: We retrospectively evaluated 125 consecutive TAVR patients and analyzed the first 51 patients in whom we implanted the new Sapien 3 device via transfemoral access. RESULTS: In patients implanted with the Sapien 3 device significant residual paravalvular regurgitation after TAVR was virtually absent with the vast majority having none or trace postinterventional aortic regurgitation on angiography or echocardiography (92.2% and 80.4% respectively). None of the patients had more than mild paravalvular regurgitation. Major vascular access site complications or major bleeding according to the VARC II criteria were not observed in our cohort, minor vascular complications and minor bleeding occurred in 7.8% and 5.9% respectively. If vascular complications occurred, they were related to closure device failure. Thirty day outcome showed a 1.9% major stroke rate and 3.9% death rate. However, we observed a 25.5% permanent pacemaker rate in our Sapien 3 cohort. CONCLUSIONS: Implantation of the new third generation Sapien 3 device resulted in excellent procedural and short term outcome. Significant paravalvular regurgitation was virtually absent. However, the increased rate of postinterventional pacemaker implantations needs to be analyzed in a larger cohort of patients.

Procedural results with the self-expanding 31 mm CoreValve aortic bioprosthesis in patients with large annuli.

BACKGROUND: Transcatheter aortic valve implantation has become an established treatment for severe aortic stenosis in patients with high surgical risk. Due to its specific design, the self-expanding 31 mm CoreValve prosthesis can be technically challenging. This is especially true for patients with large annuli above 27.5 mm for which the CoreValve 31 mm device is the only option. OBJECTIVES: To evaluate procedural results and short-term outcome with the 31 mm CoreValve device in patients with large annuli. METHODS: We retrospectively analyzed 54 patients in whom we implanted a 31 mm self-expanding CoreValve bioprosthesis and compared them to 50 consecutive patients implanted with the smaller 29 mm device within the same period of time. RESULTS: Patients with the 31 mm prosthesis had significantly higher rates of postinterventional pacemaker implantations (35% vs. 20%; P = 0.036) despite similar implantation depths (6.5 ± 4 vs. 7.5 ± 4; P = 0.34). However, the number of deep implantations (>8 mm) was significantly higher (P = 0.045). No significant difference could be observed with respect to cases with ≥Grade 2 postinterventional aortic regurgitation (8% vs. 12.9%; P = 0.5294). Major vascular complications (4% vs. 3.7%; P = ns), 30-day mortality (8% vs. 7.7%; P = ns), and major stroke (3.8% vs. 2%; P = ns) were not different between the 2 groups. CONCLUSION: Despite the technical challenges, procedural results with the 31 mm self-expanding CoreValve prosthesis in large anatomies were similar to those with the smaller sized 29 mm version of the device. However, postinterventional pacemaker rates were significantly higher in the 31 mm cohort despite comparable implantation depths, which might be the result of the specific design of the device.