Abstract 20: Use of Administrative Claims to Ascertain Outcomes in Randomized Clinical Trials for Transcatheter Aortic Valve Replacement: Findings From the Extending Trial-based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Jordan B Strom ◽  
Yuansong Zhao ◽  
Kamil F Faridi ◽  
Neel Butala ◽  
Hector Tamez ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Claims Data ◽  
Pacemaker Implantation ◽  
Kidney Injury ◽  
Trial Data ◽  
P Value ◽  
Administrative Claims ◽  
Transcatheter Aortic Valve ◽  
Linkage Rate ◽  
Secondary Outcomes

Introduction: Administrative claims may be a low cost alternative to traditional clinical trial event adjudication, but whether claims data can validly substitute for adjudicated outcomes to reproduce trial-derived treatment effects is uncertain. Methods: We linked adults aged ≥65 in the US CoreValve Pivotal High Risk (HiR) and Surgical or Transcatheter Aortic Valve Replacement in Intermediate-Risk Patients (SURTAVI) Trials to 100% Medicare inpatient claims (2003-2016). Primary (i.e. death and stroke) and secondary trial endpoints (i.e. bleeding, acute kidney injury, cardiogenic shock, pacemaker implantation, aortic valve reintervention, myocardial infarction, and major adverse cerebrovascular and cardiovascular events [MACCE]) were compared across treatment arms (i.e. TAVR vs. SAVR) using outcomes derived from claims at 1 year (HiR) or 2 years (SURTAVI), and compared with trial-adjudicated outcomes. Results: Among 600 linked HiR participants (linkage rate 80.0%), the rate of the trial’s primary endpoint of all-cause mortality at 1-year was 13.7% for TAVR and 16.4% for SAVR using both trial data (HR 0.84, 95% CI 0.65-1.09; p = 0.33) and claims data (HR 0.86, 95% CI 0.66-1.11; p = 0.34; interaction p-value = 0.80) ( Figure ). Among 1004 linked SURTAVI trial participants (linkage rate 60.5%), the trial’s primary endpoint of combined death and stroke at 2-years was 12.9% for TAVR and 13.1% for SAVR using trial data (HR 1.08, 95% CI 0.79-1.48, p = 0.90), and 11.3% for TAVR and 12.5% for SAVR patients using claims data (HR 1.02, 95% CI 0.73-1.41, p = 0.58; interaction p-value = 0.89) ( Figure ). Procedural secondary outcomes (e.g., aortic valve reintervention, pacemaker implantation) were more concordant between trials and claims than non-procedural outcomes (e.g. bleeding, cardiogenic shock, stroke). Acute kidney injury, myocardial infarction, and MACCE outcomes were also concordant between data types. Conclusions: In both HiR and SURTAVI trials, ascertainment of trial primary endpoints using claims reproduced both the magnitude and direction of treatment effect observed in adjudicated event data. Non-fatal secondary outcomes displayed variable concordance. Use of claims to substitute for adjudicated outcomes in traditional trial treatment comparisons may be a valid alternative for some endpoints.

scholarly journals Single centre experience in 1202 biological prosthesis: a comparison between sutured, sutureless and surgical transcatheter aortic valve

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
C Mariani ◽  
G Murana ◽  
L Botta ◽  
G Gliozzi ◽  
G Folesani ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Primary Outcome ◽  
Pacemaker Implantation ◽  
Kidney Injury ◽  
P Value ◽  
Valve Prosthesis ◽  
Biological Prosthesis ◽  
Secondary Outcomes

Abstract Background/Introduction Different types of bio-prosthesis are now available for the treatment of aortic valve disease. In absence of the “ideal” heart valve prosthesis, the best choice may be customized on the basis of the patient's profile. Purpose The aim of this study was to compare results in different subgroups of bio-prosthesis in elderly patients (>75 years old) undergoing conventional or surgical trans-catheter aortic valve replacement (AVR). Primary outcome was all cause mortality, secondary outcomes were: early post-operative complications (stroke, AV-block, acute kidney injury requiring temporary dialysis), freedom from structural vascular disease (SVD) and from re-operation. Methods In this retrospective study we analysed 1202 patients over 75 years old, underwent AVR from 2002 to 2018. Inclusion criteria were: age >75 years underwent AVR; we divided our population in 3 groups according to different strategy: primary aortic valve replacement with sutured (group 1, n=1005), sutureless (group 2, n=103) or surgical trans-catheter aortic valve replacement (group 3, n=94). Exclusion criteria: concomitant cardiac procedure other than coronary artery by-pass graft (CABG) or endocarditis. Patient and disease characteristics are described as numbers and percentages, continuous data were expressed using mean and standard deviation. Differences between groups were evaluated using either Student t-test or Mann-Whitney U test or ANOVA test. Survival curves of the primary outcome and freedom from secondary outcomes were built with the Kaplan-Meier method. Results The mean age of the overall population was 80.5±3.6 years with a mean STS score of assessed at 2.79±2.2% (2.27±1.0 for standard AVR, 3.3±2.2% for sutureless and 6.4±4.5 for S-TAVR, p-value<0.001). Early outcomes are depicted in figure 1. The overall 30-day mortality was 2.9%; among the different groups we observed 2.3%, 4.9% and 7.2% for sutured, sutureless and surgical-TAVR, respectively (p-value=0.01). The groups statistically differed also for permanent pacemaker implantation (sutured AVR 2.2%, sutureless AVR 4.9%, TAVR 9.6% (p-value<0.001) and acute renal failure requiring temporary dialysis sutured AVR 3%, Sutureless AVR 1.9% and Surgical TAVR 9.6% (p-value=0.004). The survival rate at follow-up was significantly different among group (log-rank <0.001, figure 2). Instead, freedom from reoperation was similar between cohorts (figure 2.) Conclusion(s) The outcomes of surgical AVR in a elderly population could be safely guaranteed with different biological prosthesis and operative techniques. A patient tailored approach should be always advised to improve current available transcatheter options. FUNDunding Acknowledgement Type of funding sources: None. Figure 1 Figure 2

P1787Peripheral vascular access for transcatheter aortic valve implantation: transcarotid versus femoral access

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T A F Folliguet
Keyword(s):  
Renal Failure ◽  
Aortic Valve ◽  
Pacemaker Implantation ◽  
Permanent Pacemaker ◽  
P Value ◽  
Chi Square ◽  
Transcatheter Aortic Valve ◽  
All Cause Mortality ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Abstract Objectives The transcarotid (TC) approach for transcatheter aortic valve implantation (TC-TAVI) is potentially an optimal alternative to the gold standard, transfemoral approach. Unfortunately, few studies are reported regarding the safety and efficacy of TC-TAVI. Methods Using data from the national prospective French registry in France - the FRANCE TAVI registry – included a total of 12804 patients entered in the dataset between January 2013 and December 2015. Patients who underwent TF-TAVI or TC-TAVI were 11033 (10598 and 435 respectively) and represented our study cohort. The primary endpoints were perioperative all-cause mortality (either in-hospital mortality or 30-day mortality) and in-hospital complications (annulus rupture, aortic dissection, valve migration, cardiac tamponade, stroke, STEMI, permanent pacemaker implantation, pulmonary embolism, renal failure, renal dialysis). All-cause mortality at follow-up was a secondary endpoint of the study. Results Among 11033 patients included in the current study 10598 (96%) underwent a femoral TAVI, and 435 (4.1%) a TC-TAVI. Patients in the TC-TAVI access group presented with a higher risk profile (mean logistic EuroSCORE1 8.2 vs. 20.3, P<0.001), with a higher rate of peripheral vascular disease, known coronary artery disease, chronic pulmonary disease and renal failure, dialysis and urgent status of TAVI. Four hundred and nineteen patients (3.8%) died during in-hospital stay, with no differences between the two groups (p-value 0.73). TC-TAVI had higher postoperative incidence of stroke (4.4% vs 1.9%, chi-square p-value 0.001), ST elevated myocardial infarction (STEMI) (0.7% vs 0.2%, chi-square p-value 0.05), permanent pacemaker implantation (18.9% vs 15.2%, chi-square p-value 0.04), infections (6.7% vs 4.0%, chi-square p-value 0.01), bleeding (9.2% vs 4.7%, chi-square p-value <0.001), renal failure (5.1% vs 3.3%, chi-square p-value 0.06) and dialysis (5.1% vs 3.1%, chi-square p-value 0.03). Conversely, TF-TAVI was likely to have vascular complications (7.7% vs 3.2%, <0.001) There was no difference in short or midterm mortality rates. The Kaplan-Meier estimates of survival at 1 and 2 years were respectively 85.8%±0.4%, and 75.8%±0.6%. Conclusion Compared to femoral peripheral TAVI, TC-TAVI is safe, and associated with similar outcome except for a higher postoperative incidence of stroke and a twice-lower rate of access site-related complications. It should be considered in case of non-femoral peripheral access as the second access choice, to increase the overall safety of TAVI procedures.

scholarly journals The ACURATE neo2 valve system for transcatheter aortic valve implantation: 30-day and 1-year outcomes

2021 ◽  
Author(s):  
Helge Möllmann ◽  
David M. Holzhey ◽  
Michael Hilker ◽  
Stefan Toggweiler ◽  
Ulrich Schäfer ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Pacemaker Implantation ◽  
Paravalvular Leak ◽  
Transcatheter Aortic Valve ◽  
All Cause Mortality ◽  
Valve Thrombosis ◽  
Aortic Valve Implantation ◽  
And Performance ◽  
Valve Implantation

Abstract Background Transcatheter aortic valve implantation (TAVI) has become standard treatment for elderly patients with symptomatic severe aortic valve stenosis. The ACURATE neo AS study evaluates 30-day and 1-year clinical and hemodynamic outcomes in patients treated with the ACURATE neo2 valve. Methods The primary endpoint of this single-arm multicenter study is 30-day all-cause mortality. Other key endpoints include device performance, echocardiographic measures assessed by an independent core laboratory, and VARC-2 clinical efficacy and safety endpoints through 12 months. Results The study enrolled 120 patients (mean age 82.1 ± 4.0 years; 67.5% female, mean baseline STS score 4.8 ± 3.8%). The VARC-2 composite safety endpoint at 30 days occurred in 13.3% of patients. All-cause mortality was 3.3% at 30 days and 11.9% at 1 year. The 30-day stroke rate was 2.5% (disabling stroke 1.7%); there were no new strokes between 30 days and 12 months. The rate of permanent pacemaker implantation was 15.0% (18/120) at 30 days and 17.8% (21/120) at 1 year. No patients required re-intervention for valve-related dysfunction and there were no cases of valve thrombosis or endocarditis. Patients demonstrated significant improvement in mean aortic valve gradient (baseline 38.9 ± 13.1 mmHg, 1 year 7.8 ± 3.5 mmHg; P < 0.001 in a paired analysis). In the overall population, paravalvular leak was evaluated at 1 year as none/trace in 60.5%, mild in 37.0%, and moderate in 2.5%; no patients had severe PVL. Conclusions One-year outcomes from the ACURATE neo AS study support the safety and performance of TAVI with the ACURATE neo2 valve. Graphic Abstract

Temporal trends in utilization of transcatheter aortic valve implantation and patient characteristics – a nationwide cohort study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J.E Strange ◽  
C Sindet-Pedersen ◽  
G Gislason ◽  
C Torp-Pedersen ◽  
E.L Fosboel ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Temporal Trends ◽  
Patient Characteristics ◽  
P Value ◽  
Transcatheter Aortic Valve ◽  
History Of ◽  
Aortic Valve Implantation ◽  
Valve Implantation ◽  
First Time

Abstract Introduction In recent years, there has been a surge in the utilization of transcatheter aortic valve implantation (TAVI) for the treatment of severe symptomatic aortic stenosis. Randomized controlled trials have compared TAVI to surgical aortic valve replacement (SAVR) in patients at high-, intermediate-, and low perioperative risk. As TAVI continues to be utilized in patients with lower risk profiles, it is important to investigate the temporal trends in “real-world” patients undergoing TAVI. Purpose To investigate temporal trends in the utilization of TAVI and examine changes in patient characteristics of patients undergoing first-time TAVI. Methods Using complete Danish nationwide registries, we included all patients undergoing first-time TAVI between 2008 and 2017. To compare patient characteristics, the study population was stratified according to calendar year in the following groups: 2008–2009, 2010–2011, 2012–2013, 2014–2015, and 2016–2017. Results We identified 3,534 patients undergoing first-time TAVI. In 2008–2009, 180 patients underwent first-time TAVI compared with 1,417 patients in 2016–2017, resulting in a 687% increase in TAVI procedures performed. During the study period, the median age remained stable (2008–2009: Median age 82 year [25th–75th percentile: 78–85] vs. 2016–2017: Median age 81 years [25th–75th percentile: 76–85]; P-value: 0.06). The proportion of men undergoing first-time TAVI increased over the years (2008–2009: 49.4% vs 2016–2017: 54.9%; P-value for trend: &lt;0.05), also the proportion with diabetes increased (2008–2009: 12.2% vs. 2016–2017: 19.3%; P-value for trend: &lt;0.05). The proportion of patients with a history of stroke decreased over the years (2008–2009: 13.9% vs. 2016–2017: 12.1%; P-value for trend: &lt;0.05). The same trend was seen in patients with a history of myocardial infarction (2008–2009: 24.4% vs. 2016–2017: 11.9%; P-value for trend: &lt;0.05), ischaemic heart disease (2008–2009: 71.7% vs. 2016–2017: 29.4%; P-value for trend: &lt;0.05), and heart failure (2008–2009: 45.6% vs. 2016–2017: 29.4%; P-value for trend: &lt;0.05). Conclusions In this nationwide study, there was a marked increase in the utilization of TAVI in the years 2008–2017. Patients undergoing first-time TAVI had a decreasing comorbidity burden, while the age of the patients at first-time TAVI remained stable. Funding Acknowledgement Type of funding source: None

scholarly journals Dose approach matter? A meta-analysis of outcomes following transfemoral versus transapical transcatheter aortic valve replacement

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ruikang Guo ◽  
Minghui Xie ◽  
Wai Yen Yim ◽  
Wenconghui Wu ◽  
Weiwei Jiang ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Aortic Valve ◽  
Transcatheter Aortic Valve Replacement ◽  
Observational Studies ◽  
Meta Analysis ◽  
Kidney Injury ◽  
Vascular Complication ◽  
Permanent Pacemaker ◽  
Transcatheter Aortic Valve ◽  
Effect Model

Abstract Background Transcatheter aortic valve replacement (TAVR) has gained increasing acceptance for patients with aortic disease. Both transfemoral (TF-TAVR) and transapical (TA-TAVR) approach were widely adopted while their performances are limited to a few studies with controversial results. This meta-analysis aimed to compare the mortality and morbidity of complications between TF- versus TA-TAVR based on the latest data. Methods Electronic databases were searched until April 2021. RCTs and observational studies comparing the outcomes between TF-TAVR versus TA-TAVR patients were included. Heterogeneity assumption was assessed by an I2 test. The pooled odds ratios(OR) or mean differences with corresponding 95% confidence intervals (CI) were used to evaluate the difference for each end point using a fixed-effect model or random-effect model based on I2 test. Results The meta-analysis included 1 RCT and 20 observational studies, enrolling 19,520 patients (TF-TAVR, n = 11,986 and TA-TAVR, n = 7,534). Compared with TA-TAVR, TF-TAVR patients showed significantly lower rate of postoperative in-hospital death (OR = 0.67, 95% CI 0.59–0.77, P < 0.001) and 1-year death (OR = 0.53, 95% CI 0.41–0.69, P < 0.001). Incidence of major bleeding and acute kidney injury were lower and length of hospital stay was shorter, whereas those of permanent pacemaker and major vascular complication were higher in TF-TAVR patients. There were no significant differences between TF-TAVR versus TA-TAVR for stroke and mid-term mortality. Conclusions There were fewer early deaths in patients with transfemoral approach, whereas the number of mid-term deaths and stroke was not significantly different between two approaches. TF-TAVR was associated with lower risk of bleeding, acute kidney injury as well as shorter in-hospital stay, but higher incidence of vascular complication and permanent pacemaker implantation.

scholarly journals Magna Graecia transcatheter aortic valve implantation registry: data on contrast medium osmolality and postprocedural acute kidney injury

Data in Brief ◽  
2021 ◽  
Vol 35 ◽  
pp. 106827
Author(s):  
Fortunato Iacovelli ◽  
Antonio Pignatelli ◽  
Alessandro Cafaro ◽  
Eugenio Stabile ◽  
Luigi Salemme ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Aortic Valve ◽  
Contrast Medium ◽  
Transcatheter Aortic Valve Implantation ◽  
Kidney Injury ◽  
Registry Data ◽  
Transcatheter Aortic Valve ◽  
Magna Graecia ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Copeptin as a novel biomarker for detecting early renal dysfunction after TAVI

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J.S Wolter ◽  
J Reifart ◽  
M Renker ◽  
S.D Kriechbaum ◽  
U Fischer-Rasokat ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Serum Creatinine ◽  
Renal Dysfunction ◽  
Venous Blood ◽  
Kidney Injury ◽  
Blood Draw ◽  
Amino Acid Peptide ◽  
Transcatheter Aortic Valve ◽  
Prolonged Hospital ◽  
Stage 1

Abstract Background Acute kidney injury (AKI) is one of the most prevalent (10–30%) complications after transcatheter aortic valve implantation (TAVI). Furthermore, AKI is accompanied by increased mortality, a higher incidence of dialysis and blood transfusion, and a prolonged hospital stay. Although measurement of serum creatinine is the gold standard in diagnosing AKI, changes in serum creatinine may lag behind compromised renal function. Arginine vasopressin (AVP), or antidiuretic hormone, is a nine-amino acid peptide member of the hypothalamo-neurohypophysial axis. Copeptin is the C-terminal moiety of the AVP precursor pre-proAVP that is secreted into the circulation. Recently, copeptin has been suggested to play a role in chronic kidney injury. We evaluated the value of copeptin in the prediction of AKI in patients undergoing TAVI. Methods All patients with severe aortic valve stenosis undergoing TAVI between May 2011 and May 2016 were included in our study. AKI was defined by the VARC-2 definition. Patients with no AKI and stage 1 AKI were compared with patients with stage 2 or 3 AKI. Routine laboratory parameters, including creatinine, were measured immediately after blood draw. Additionally, venous blood samples were collected on admission and after 24, 48, and 72 hours, processed immediately, and stored at −80°C until assay. The copeptin concentration in serum was measured by a sandwich immunoluminometric assay. Results Copeptin levels were available in 642 patients who were treated by TAVI in our centre from 2012–2016. AKI was detected in 113 patients (17.6%), including 61 patients with stage 1 (9.5%), 29 with stage 2 (4.5%), and 23 with stage 3 (3.6%). There were no differences among these patients in baseline measurements, but serum copeptin increased in all patients with AKI 24 h post-procedure according to the AKI stage: no AKI 34.5 (18.0–59.3 pmol/L), AKI stage 1: 68.7 (34.6–130.1 pmol/L); AKI stage 2: 96.0 (48.1–185.1 pmol/L); AKI stage 3: 154.9 (79.5–280.7 pmol/L); ANOVA p&lt;0.001 (Fig. 1). Copeptin showed an earlier and sharper increase than creatinine (Fig. 1), with a negative predictive value of 0.97 to rule out AKI after 24 h. Conclusion AKI subsequent to TAVI is a common and harmful complication that occurred in almost every 5th patient (17.6%) in our cohort. AVP is secreted in response to hypotension, which commonly occurs during TAVI. In our cohort of TAVI patients, those who developed AKI after TAVI showed a rapid increase in copeptin that was earlier than that of creatinine. In light of these observations, copeptin could be a new parameter for detecting early renal dysfunction. Figure 1 Funding Acknowledgement Type of funding source: None

scholarly journals Transcatheter aortic valve replacement for bicuspid aortic valve stenosis with first- and new-generation bioprostheses: a systematic review and meta-analysis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D Ueshima ◽  
L.N.F Nai Fovino ◽  
S.J.B Brener ◽  
A.P Pavei ◽  
C.F Fraccaro ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Bicuspid Aortic Valve ◽  
Meta Analysis ◽  
Pacemaker Implantation ◽  
Vascular Complications ◽  
Device Failure ◽  
Paravalvular Leakage ◽  
Transcatheter Aortic Valve ◽  
Outcome Differences ◽  
New Generation

Abstract Background Subjects with bicuspid aortic valve (BAV) have been excluded from transcatheter aortic valve re- placement (TAVR) randomized trials. Methods With this meta-analysis of observational studies we first compared TAVR outcomes of BAV vs. tricuspid aortic valve (TAV) patients, stratifying the results by device generation. Then, we looked for differences between balloon-expandable (BE) and self-expandable (SE) bioprostheses in BAV patients. Primary outcome was 30-day mortality. Secondary outcomes were 30-day stroke, moderate-severe paravalvular leakage, new pacemaker im- plantation, vascular complications and 1-year mortality. Results Thirteen studies (11,032 patients, 7291 TAV and 3741 BAV) and seven studies (706 patients, 367 treated with BE, 339 with SE valve) met inclusion criteria. Thirty-day (OR=1.13; 95% CI: 0.88–1.46, p=0.33) and 1-year mortality (OR=1.02; 95% CI: 0.77–1.37, p=0.87) were similar between patients receiving TAVR for BAV or TAV. Subjects treated for BAV were at higher risk of conversion to conventional surgery (OR=2.35; 95% CI: 1.30–4.23, p=0.005), implantation of a second valve (OR=2.06; 95% CI: 1.31–3.25; p=0.002), moderate/severe paravalvular leakage (PVL) (OR=1.67; 95% CI: 1.29–2.17; p=0.0001) and device failure (OR=1.26; 95% CI: 1.02–1.56; p=0.04). Rates of adverse events decreased significantly with the use of new-generation devices, but outcome differences remained consistent. BAV patients treated with BE vs. SE valves had similar 30-day and 1-year mortality, stroke and moderate-severe PVL. Balloon-expandable valves were associated with lower rates of a second valve and new pacemaker implantation but carried higher risk of annular rupture. Conclusions BAV patients treated with TAVR had similar 30-day and 1-year mortality as well as stroke and new pacemaker implantation rates compared to TAV subjects, but carried higher risk of moderate/severe PVL, conver- sion to surgery and device failure. Event rates significantly decreased with the use of new-generation devices, but TAVR still showed better procedural results in TAV compared to BAV. Funding Acknowledgement Type of funding source: None

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