Quality of life after percutaneous paravalvular leak closure - a prospective registry.

Introduction: Presence of paravalvular leaks (PVLs) can lead to heart failure, which decreases quality of life (QoL). Percutaneous closure is becoming the first-line treatment of PVLs, but whether such a procedure could improve QoL in these patients has never been examined. Aim: To examine changes in scores of the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and Kansas City Cardiomyopathy Questionnaire (KCCQ) after percutaneous PVL closure. Material and methods: Forty subjects with heart failure symptoms and at least moderate PVL were included in this prospective registry. QoL was assessed at baseline and during a 12-month follow-up after percutaneous PVL closure by MLHFQ and KCCQ questionnaires. Changes in NT-proBNP and lactate dehydrogenase (LDH) levels were also analyzed. Results: Technical success (TS) was achieved in 97.5% of cases and procedural success (PS) in 85% of cases. In the group with PS a significant decrease in MLHFQ score as well as an increase in scores of all KCCQ domains was observed. No statistically significant changes were observed in the group without PS, mainly due to the small sample size. Conclusions: Percutaneous PVL closure is associated with better QoL during a 12-month follow-up provided PS was achieved. Due to the low number of subjects in whom PS was not achieved, it is not possible to determine the influence of a failed procedure in this group of patients.

Cardiovascular magnetic resonance and transesophageal echocardiography in patients with prosthetic valve paravalvular leaks: towards an accurate quantification and stratification.

BACKGROUND: Objective assessment of prosthetic paravalvular leak (PVL) is complex and challenging even in transesophageal echocardiography (TEE). Our aim was to assess the value of cardiovascular magnetic resonance (CMR) in quantifying PVL in aortic (AVR) or mitral valve (MVR) replacement. METHODS: Thirty-one patients (62 ± 15.1 years, 63% males) with a preliminary diagnosis of significant PVL (AVR, n-23; MVR, n = 8) were recruited. The TEE PVL grading was based on the semi-quantitative (SQ) TEE according to the VARC II PVL classification (%PVL: mild < 10%; moderate 10%-30%; severe > 30%). Non-contrast CMR studies were acquired at 1.5 T with a quantitative approach (phase-contrast velocity encoded imaging). The CMR PVL severity was classified according to regurgitant fraction (RF: (1) mild ≤ 20%, (2) moderate 21%-39%, or (3) severe ≥ 40%). RESULTS: All patients revealed symptoms of heart failure (71%: New York Heart Association [NYHA] II; 91%: N-terminal pro-B-type natriuretic peptide [NT-proBNP] > 150 pg/ml) and typical cardiovascular disease risk factors. The SQ-TEE results revealed several categories: (1) mild (n = 5; 16%), (2) moderate (n = 21; 67%), and (3) severe (n = 5; 16%) PVL. However, CMR PVL RF reclassified the severity of PVL: (1) mild to moderate (in 80%), (2) moderate to severe (in 47%), and (3) severe to moderate (in 40%). The receiver operating characteristic analysis showed that SQ-TEE and CMR PVL-vol and -RF predicted the upper tertile of NT-proBNP (> 2000 pg/ml) with the best sensitivity for CMR parameters. CONCLUSION: The SQ-TEE showed moderate agreement with CMR and underestimated a considerable number of AVR or MVR-PVL.

Association between coronary artery bypass graft center volume and year-to-year outcome variability: New York and California statewide analysis.

OBJECTIVE: We evaluated whether volume-based, rather than time-based, annual reporting of center outcomes for coronary artery bypass grafting may improve inference of quality, assuming that large center-level year-to-year outcome variability is related to statistical noise. METHODS: We analyzed 2012 to 2016 data on isolated coronary artery bypass grafting using statewide outcome reports from New York and California. Annual changes in center-level observed-to-expected mortality ratio represented stability of year-to-year outcomes. Cubic spline fit related the annual observed-to-expected ratio change and center volume. Volume above the inflection point of the spline curve indicated centers with low year-to-year change in outcome. We compared observed-to-expected ratio changes between centers below and above the volume threshold and observed-to-expected ratio changes between consecutive annual and biennial measurements. RESULTS: There were 155 centers with median annual volume of 89 (interquartile range, 55-160) for isolated coronary artery bypass grafting. The inflection point of observed-to-expected ratio variability was observed at 111 cases/year. Median year-to-year observed-to-expected ratio change for centers performing less than 111 cases (62 centers) was greater at 0.83 (0.26-1.59) compared with centers performing 111 cases or more (93 centers) at 0.49 (022-0.87) (P < .001). By aggregating the outcome over 2 years, centers above the 111-case threshold increased from 93 centers (60%) to 118 centers (76%), but the median observed-to-expected change for all centers was similar between annual aggregates at 0.70 (0.26-1.22) compared with observed-to-expected change between biennial aggregates at 0.54 (0.23-1.02) (P = .095). CONCLUSIONS: Center-level, risk-adjusted coronary artery bypass grafting mortality varies significantly from one year to the next. Reporting outcomes by specific case volume may complement annual reports.

Prospective Evaluation of the NETest as a Liquid Biopsy for Gastroenteropancreatic and Bronchopulmonary Neuroendocrine Tumors: An ENETS Center of Excellence Experience.

BACKGROUND: There is a substantial unmet clinical need for an accurate and effective blood biomarker for neuroendocrine neoplasms (NEN). We therefore evaluated, under real-world conditions in an ENETS Center of Excellence (CoE), the clinical utility of the NETest as a liquid biopsy and compared its utility with chromogranin A (CgA) measurement. METHODS: The cohorts were: gastroenteropancreatic NEN (GEP-NEN; n = 253), bronchopulmonary NEN (BPNEN; n = 64), thymic NEN (n = 1), colon cancer (n = 37), non-small-cell lung cancer (NSCLC; n = 63), benign lung disease (n = 59), and controls (n = 86). In the GEPNEN group, 164 (65%) had image-positive disease (IPD, n = 135) or were image-negative but resection-margin/biopsy-positive (n = 29), and were graded as G1 (n = 106), G2 (n = 49), G3 (n = 7), or no data (n = 2). The remainder (n = 71) had no evidence of disease (NED). In the BPNEN group, 43/64 (67%) had IPD. Histology revealed typical carcinoids (TC, n = 14), atypical carcinoids (AC, n = 14), small-cell lung cancer (SCLC, n = 11), and large-cell neuroendocrine carcinoma (LCNEC, n = 4). Disease status (stable or progressive) was evaluated according to RECIST v1.1. Blood sampling involved NETest (n = 563) and NETest/CgA analysis matched samples (n = 178). NETest was performed by PCR (on a scale of 0-100), with a score ≥20 reflecting a disease-positive status and >40 reflecting progressive disease. CgA positivity was determined by ELISA. Samples were deidentified and measurements blinded. The Kruskal-Wallis, Mann-Whitney U, and McNemar tests, and the area under the curve (AUC) of the receiver-operating characteristics (ROC) were used in the statistical analysis. RESULTS: In the GEPNEN group, NETest was significantly higher (34.4 ± 1.8, p < 0.0001) in disease-positive patients than in patients with NED (10.5 ± 1, p < 0.0001), colon cancer patients (18 ± 4, p < 0.0004), and controls (7 ± 0.5, p < 0.0001). Sensitivity for detecting disease compared to controls was 89% and specificity was 94%. NETest levels were increased in G2 vs. G1 (39 ± 3 vs. 32 ± 2, p = 0.02) and correlated with stage (localized: 26 ± 2 vs. regional/distant: 40 ± 3, p = 0.0002) and progression (55 ± 5 vs. 34 ± 2 in stable disease, p = 0.0005). In the BPNEN group, diagnostic sensitivity was 100% and levels were significantly higher in patients with bronchopulmonary carcinoids (BPC; 30 ± 1.3) who had IPD than in controls (7 ± 0.5, p < 0.0001), patients with NED (24.1 ± 1.3, p < 0.005), and NSCLC patients (17 ± 3, p = 0.0001). NETest levels were higher in patients with poorly differentiated BPNEN (LCNEC + SCLC; 59 ± 7) than in those with BPC (30 ± 1.3, p = 0.0005) or progressive disease (57.8 ± 7), compared to those with stable disease (29.4 ± 1, p < 0.0001). The AUC for differentiating disease from controls was 0.87 in the GEPNEN group and 0.99 in BPC patients (p < 0.0001). Matched CgA analysis was performed in 178 patients. In the GEPNEN group (n = 135), NETest was significantly more accurate for detecting disease (99%) than CgA positivity (53%; McNemar test χ2 = 87, p < 0.0001). In the BPNEN group (n = 43), NETest was significantly more accurate for disease detection (100%) than CgA positivity (26%; McNemar's test χ2 = 30, p < 0.0001). CONCLUSIONS: The NETest is an accurate diagnostic for GEPNEN and BPNEN. It exhibits tumor biology correlation with grading, staging, and progression. CgA as a biomarker is significantly less accurate than NETest. The NETest has substantial clinical utility that can facilitate patient management.

Midterm procedural and clinical outcomes of percutaneous paravalvular leak closure with the Occlutech Paravalvular Leak Device.

AIMS: The aim of this study was to assess the efficacy and safety of the Occlutech Paravalvular Leak Device (PLD) for the percutaneous closure of paravalvular leaks (PVL). METHODS AND RESULTS: Patients with PVL were enrolled at 21 sites from nine countries. Indications for PVL closure were heart failure and/or haemolytic anaemia. Endpoint measures were changes in PV regurgitation grade, NYHA class and requirement for haemolysis-related transfusion. One-hundred and thirty-six patients with mitral (67.6%) or aortic (32.4%) leaks were included (mean age 66.7 years, 58% male); 31% had multiple PVLs. The proportion of patients with NYHA Class III/IV decreased from 77.3% at baseline to 16.9% at latest follow-up. The proportion of patients with need for haemolysis-related blood transfusion decreased from 36.8% to 5.9% and from 8.3% to 0% for ML patients and AL patients, respectively. All-cause mortality was 7.4%. Complications included interference with valve leaflets (0.7%), transient device embolisation (percutaneously solved) (0.7%), late device embolisation (0.7%), recurrent haemolytic anaemia (2.2%), new-onset haemolytic anaemia (0.7%), valve surgery (2.2%), need for repeat closure (0.7%), complications at femoral puncture site (0.7%) and arrhythmias requiring treatment (4.4%). CONCLUSIONS: PVL closure with the Occlutech PLD demonstrated a high success rate associated with significant clinical improvement and a relatively low rate of serious complications. Visual summary. PVL characteristics, leak approach, device types and midterm procedural and clinical outcomes of percutaneous paravalvular leak closure with the Occlutech® PLD. Transcatheter PVL closure with the specifically designed PLD was demonstrated to be effective with a relatively low rate of major complications. Procedural success for ML and AL closure was high with a low rate of residual or recurrent leaks. Significant improvement of NYHA class, and reduction of haemolytic anaemia and transfusion dependency were achieved.

Prospective registry validating the reproducibility of mitral paravalvular leak measurements in a standardized real-time three-dimensional transesophageal echocardiography algorithm for optimal choice of the closure device.

INTRODUCTION: Transcatheter paravalvular leak closure (TPVLC) has become a well-established method of treatment for patients with paravalvular leak (PVL) causing heart failure or significant hemolysis. Nonetheless, the method of optimal PVL sizing and subsequent device choice requires standardization. For this purpose a real-time three-dimensional transesophageal echocardiography (RT-3D TEE) algorithm was developed in our institution. It has proven clinically useful with results successfully translated into type, size, and number of occluding devices. Still, the reproducibility of measurements has not been previously verified. AIM: To investigate the intra- and inter-observer variability of measurements in a RT-3D TEE algorithm developed for optimal choice of occluding devices during TPVLC. MATERIAL AND METHODS: Three echocardiographers, with RT-3D TEE clinical experience ranging from 1 to 8 years, analyzed recordings of 20 mitral PVLs according to our standardized protocol. PVL channel cross-sectional area (CSA), width (W) and length (L) were measured at the level of the vena contracta. Each echocardiographer performed the measurements twice on different days, individually and blinded to other participants' results. RESULTS: Measurements of PVL CSA, W and L showed intra- and interobserver agreement of 0.98, 0.93, 0.92 and 0.95, 0.88, 0.87, respectively. CONCLUSIONS: The presented algorithm enables standardized utilization of RT-3D TEE for appropriate TPVLC device choice with low intra- and inter-observer variability.