bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparison of trans-catheter closure of paravalvular leak versus surgical approach-outcomes and cost analysis
Authors: Pu J , Wu W.H , Ke Y.T , Ma X.H , Huang L.J 
Published: November 2020

Abstract

Background
The outcomes and costs of trans-catheter closure (TC) of paravalvular leak (PVL) compared with surgical closure (SC) are rarely described.

Purpose
The aim of the study was to assess the outcomes and hospital costs of patients who underwent TC or SC of PVL in our center.

Methods
Patients who underwent TC and SC of PVL between Jan. 2016 and Dec. 2019 were enrolled. Baseline characteristics, procedural, in-hospital and mid-term outcomes and hospital costs were compared.

Results
A total of 141 patients were studied (TC, n=65 and SC, n=76). The patients were elder in TC group (56.8±12.8 years vs. 50.1±12.8 years, p=0.002). Technical success was higher in SC group (83.1% vs. 98.7%, p&lt;0.001). Procedure room time (93±38 min vs. 395±132 min, p&lt;0.001), intensive care unit time (0 h vs. 25 h, p&lt;0.001), length of stay from hospitalization to discharge (7 days vs. 21 days, p&lt;0.001) and costs (¥45090±19343 vs. ¥164165±94300, p&lt;0.001) were significantly less in TC group. After risk adjustment, there was no significant differences between in 30 days survival between TC group and SC group. However, the residual PVLs were less in SC group (43.1% vs. 12.0%, p=0.012). At a median follow-up of 21 months, there was a trend towards reduce all-cause death following TC versus SC (OR=0.054, 95% CI: 0.070 to 0.445, p=0.007).

Conclusions
SC for PVL is associated with higher technical rates and less residual shunt. But, the shorter length of stay and lower resources use with TC group significantly reduce hospital costs. In addition, TC achieve a better mid-term results in survival.

Funding Acknowledgement
Type of funding source: None
P2Y12 inhibition by clopidogrel increases adverse clinical outcomes in patients undergoing transcatheter aortic valve replacement
Authors: Matsushita K , Marchandot B , Kibler M , Sato C , Heger J , Peillex M , Trimaille A , Hess S , Grunebaum L , Ohana M , Reydel A , Jesel L , Ohlmann P , Morel O 
Published: November 2020

Abstract

Introduction
Current recommendations support short-term dual antiplatelet therapy (DAPT) for patients undergoing transcatheter aortic valve replacement (TAVR) despite no relevant study exploring the extent of platelet inhibition by clopidogrel.

Purpose
To assess whether P2Y12 inhibition by clopidogrel as evaluated by vasodilator-stimulated phosphoprotein flow cytometry test (VASP-FCT) impacts 1-year clinical outcomes in patients undergoing TAVR.

Methods
Patients were included in a prospective registry between February 2010 and May 2019. VASP-FCT was assessed 24h after the procedure. Responder to clopidogrel was defined by a platelet reactivity index ≤50%.

Results
Of 640 patients who underwent TAVR with preprocedural clopidogrel therapy, we enrolled 491 patients for whom VASP data were available. Responders were identified in 22% (n=110) of patients and low responders were 78% (n=381) of patients. Low body mass index, active cancer, and clopidogrel on admission were found to be independent predictors of responder. Mean transaortic pressure gradient was lower in the responder group at 1-month post-TAVR (9.9±4.4 mmHg vs. 11.2±5.8 mmHg, p=0.03) but was similar at 1-year (11.5±6.2 mmHg vs. 11.9±7.4 mmHg, p=0.74). By multivariate Cox regression analysis, patients responding to clopidogrel (hazard ratio [HR]: 2.19; 95% confidence interval [CI]: 1.04 to 3.64; p=0.04), prior PCI (HR: 2.12; 95% CI: 1.07 to 4.37; p=0.03), and mean transaortic pressure gradient at baseline (HR: 0.07; 95% CI: 0.01 to 0.70; p=0.02) were identified as independent predictors of 1-year adverse clinical outcomes, including all-cause death, myocardial infarction, stroke, and heart failure hospitalization.

Conclusions
Appropriate P2Y12 inhibition by clopidogrel is a major determinant of adverse clinical events after TAVR. In sum, the present data challenges the need of DAPT as a standard therapy during TAVR.
Figure 1

Funding Acknowledgement
Type of funding source: None
Six-month and one-year outcomes with the PASCAL transcatheter valve repair system for patients with mitral regurgitation from the multicentre, prospective CLASP study
Authors: Spargias K , Szerlip M , Kar S , Makkar R , Kipperman R , O'Neill W , Ng M , Fam N , Rinaldi M , Smith R , Walters D , Schafer U , Latib A , Marcoff L , Webb J 
Published: November 2020

Abstract

Background
Transcatheter mitral valve repair has emerged as a viable option for treating mitral regurgitation (MR). We report results from the multicentre, prospective, single arm CLASP study with the PASCAL transcatheter valve repair system.

Methods
109 patients with clinically significant MR deemed candidates for transcatheter repair by the local heart team were treated in the CLASP study. The study evaluated safety, performance, clinical and echocardiographic outcomes and included an independent clinical events committee and echocardiographic core lab. The primary safety endpoint was a composite MAE rate at 30 days of cardiovascular mortality, stroke, MI, new need for renal replacement therapy, severe bleeding, and re-intervention for study device-related complications.

Results
Mean age was 76 years, 54% male, 57% NYHA Class III/IV, 100% MR grade ≥3+ with 62% functional, 31% degenerative, 7% mixed etiology. Successful implantation was achieved in 95% of patients. At 30 days, the MAE rate was 8.3% including one cardiovascular mortality due to cardiogenic shock as a result of severe bleeding at the contralateral arterial access site for hemodynamic monitoring further complicated by disseminated intravascular coagulation, one stroke, and one conversion to mitral valve replacement surgery. In paired analysis, 88% of patients were in NYHA Class I/II (p&lt;0.001), MR grade was ≤1+ in 79% of patients and ≤2+ in 96% of patients. Significant improvements in 6MWD (+27 m, p&lt;0.001) and KCCQ (+16 points, p&lt;0.001) were observed. The six-month data will be available for presentation. In addition, we report one-year follow up of the first 62 patients (ITT): 93% one-year survival rate (Kaplan-Meier estimate), no stroke, no late reintervention, one late MI. In paired analysis, MR grade was ≤1+ in 82% of patients and ≤2+ in 100% of patients. 88% of patients were in NYHA Class I/II (p&lt;0.001), 6MWD improved by 21 m (p=0.124) and KCCQ improved by 13 points (p&lt;0.001).

Conclusions
This study demonstrates the PASCAL transcatheter valve repair system is safe and resulted in robust MR reduction with 100% of patients achieving MR ≤2+, and ∼ 80% MR ≤1+, sustained at one year. Results show high survival and low complication rates, and sustained improvements in functional status, exercise capacity, and quality of life at one year in patients with clinically significant, symptomatic MR. The CLASP IID/IIF pivotal trial is underway.

Funding Acknowledgement
Type of funding source: Private company. Main funding source(s): Edwards Lifesciences (Irvine, CA)
Copeptin as a novel biomarker for detecting early renal dysfunction after TAVI
Authors: Wolter J.S , Reifart J , Renker M , Kriechbaum S.D , Fischer-Rasokat U , Baumgarten H , Schmidt S , Nef H , Doerr O , Kim W.K , Hamm C.W , Keller T , Hocher B , Liebetrau C 
Published: November 2020

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
Outcomes following self-expanding transcatheter or surgical aortic valve implantation in patients at low operative risk stratified by need for revascularization
Authors: Tonino P , Reardon M.J , Yakubov S , Deeb G.M , Popma J.J 
Published: November 2020

Abstract

Background
Self-expanding transcatheter aortic valve implantation (TAVI) was non-inferior to surgical aortic valve replacement (SAVR) in a randomized clinical trial of patients with severe aortic stenosis at low operative risk. Randomization was stratified by the need for revascularization, but it remains unclear how this has impacted the results of TAVI and SAVR.

Purpose
To compare TAVI and SAVR outcomes in a prespecified analysis according to the need for revascularization.

Methods
A total of 1403 patients underwent attempted TAVI (n=725) or SAVR (n=678) at 87 centres worldwide. Patients were deemed at low risk of early mortality (&lt;3%) confirmed by a national screening committee. Patients were stratified by site and need for revascularization based on heart team assessment. The trial used a Bayesian study design for the 2-year primary analysis and an interim analysis was performed when 850 patients had reached 1-year follow-up.

Results
There were 85/725 (11.7%) TAVI patients and 79/678 (11.7%) SAVR patients identified as needing revascularization. Previous CABG had occurred in 3 (1.8%) patients and previous PCI had been performed in 31 (18.9%) patients. The baseline characteristics for the TAVI and SAVR cohorts are shown in the table. In the TAVI revascularization group, 44 of 85 (51.8%) received PCI concomitant or staged with TAVI and 6 of 639 (0.9%) received PCI in the no revascularization group. In the SAVR revascularization group, 65 of 79 (82.3%) underwent concomitant CABG and 27 of the 599 (4.5%) patients in the no revascularization group had concomitant CABG. Kaplan-Meier estimates of 1-year all-cause mortality or disabling stroke at the time of the interim analysis are provided for TAVI and SAVR patients by need for revascularization (Table).

Conclusions
The proportion of low-risk patients needing revascularization was small in this low risk population. The complete 1-year follow-up for the entire 1403 patient cohort will be available for presentation in August.

Funding Acknowledgement
Type of funding source: Private company. Main funding source(s): Medtronic, plc
Impact of mitral annular calcification associated mitral stenosis on clinical outcomes in patients undergoing transcatheter aortic valve implantation
Authors: Mesnier J , Urena M , Nguyen C , Carrasco J.L , Terzian Z , Fischer Q , Brochet E , Iung I , Himbert D 
Published: November 2020

Abstract

Introduction
Mitral annular calcification (MAC) is a common finding in patient undergoing transaortic valve implantation (TAVI) and can cause significant mitral stenosis (MS).

Purpose
To assess the impact of MAC associated with significant MS (MAC-MS) on clinical outcomes following TAVR.

Methods
Consecutive patients undergoing TAVI in our institution between January 2008 and May 2018, were evaluated. All echocardiogram exams before intervention were analysed to identify the presence of MAC and MAC was confirmed on computed tomography (CT) scans. Patients were included in the MAC group if there was any calcification on the mitral annulus on CT scan. Severe MAC was considered as calcification of the mitral annulus involving over 50% of the circumference. Patients with a mitral mechanical valve or bioprosthesis and without CT scan available to confirm MAC were excluded (n=62). MAC-MS was defined as the association of MAC and a mean transmitral gradient over 5 mmHg.

Results
Among 1177 consecutive finally included patients, 504 (42.8%) had MAC and 85 had a MAC-MS (7.2%, 16.9% among the MAC population). Compared to MAC without MS (MAC non-MS group) and non-MAC patients, patients with MAC-MS were more frequently women (p&lt;0.0001), had a greater BMI (p=0.002), more previous pacemaker implantation (p=0.035), smaller indexed aortic valve area and left ventricular end systolic diameter (p=0.019 and p=0.038). At 30-days after TAVR, there were no differences in stroke, major vascular complication and pacemaker implantation between groups. However, MAC-MS patients had higher rates of tamponade [Odd Ratio adjusted 3.12, 95% confidence interval (CI) 1.08–9.07, p=0.036] and mortality [Adjusted hazard Ratio (HRa) 2.83, 95% CI 1.39–5.76, p&lt;0.005] after adjustment on baseline characteristics. At 1 year, patients with MAC-MS had a higher risk of death [19 (22.1%) vs. 142 (13%); HRa 1.83, 95% CI 1.14–3.03, p=0.01] compared to MAC non-MS and non-MAC patients. Severe MAC was not a predictor of 1 year mortality.

Conclusions
Mitral stenosis due to mitral annular calcification is infrequent in patient undergoing TAVI but is associated with higher early and mid-term mortality.

Funding Acknowledgement
Type of funding source: None
Effect of renin angiotensin system blockade following transcatheter aortic valve replacement is dose dependent
Authors: Ledwoch J , Olbrich I , Poch F , Thalmann R , Fellner C , Stundl A , Bradaric C , Laugwitz K.L , Kupatt C 
Published: November 2020

Abstract

Background
There is growing body of evidence from retrospective studies that inhibition of the renin angiotensin system (RAS) improves outcome after transcatheter aortic valve replacement (TAVR). However, it remains unknown whether the effect of RAS blockade treatment on survival and left ventricular (LV) remodeling after TAVR is dose dependent.

Purpose
To assess clinical outcome and remodeling dependent on different RAS doses after TAVR.

Methods
Patients who were enrolled into our observational TAVR study at our institution were retrospectively assessed according to different dosed of RAS blockade: Group1 (no RAS blockade), group 2 (25% of the maximum daily dose), group 3 (50% of the maximum daily dose) and group 4 (100% of the maximum daily dose).

Results
A total of 323 patients between January 2015 and September 2019 were included. Patients with higher doses of RAS blockade showed a trend towards lower all-cause mortality at 3-year follow-up (56% with no RAS blockade vs. 66% with the 25% dose vs. 79% with the 50% dose vs. 78% with the full dose; p=0.063). After adjustment for baseline characteristics the difference in survival was significant (p=0.042). Besides NYHA class ≥ III and left ventricular ejection fraction (LV-EF) RAS blockade dose was identified as independent predictor for all-cause mortality (HR 0.72 [95% CI 0.54–0.97]; p=0.03). With respect to regression of LV mass index after TAVR the only significant change was observed in patients receiving the full dose.

Conclusion
The present study showed for the first time that the impact of RAS blockade treatment on clinical outcome and LV remodeling after TAVR is dose dependent.
Survival dependent on RAS dosis

Funding Acknowledgement
Type of funding source: None
Frequency and clinical impact of different definitions of moderate aortic stenosis
Authors: Du Y.U , Hashimoto G.O , Cavalcante J , Goessl M , Garcia S , Ahmed A , Lopes B , Schmidt C , Garberich R , Sorajja P 
Published: November 2020

Abstract

Background
Current echocardiographic guidelines recommend five parameters to define severity of aortic stenosis (AS): peak velocity (PV), mean gradient (MG), aortic valve area (AVA), index AVA (AVAi), and dimensionless index (DI). However, the clinical utility of these parameters for patients with moderate AS largely remain unknown.

Objective
To investigate the clinical profiles and outcomes of patients with moderate AS according to five different definitions for severity.

Methods
Using standard echocardiographic definitions, we identified patients with moderate AS who were evaluated in our health care system from 2011 to 2012. Patient demographics, morbidities, and adverse events were reviewed, including death, heart failure (HF) admission, and aortic valve replacement (AVR).

Results
We enrolled 1,042 patients (age, 75±12 yrs; 40% women). Very few patients (4%) met all five criteria for moderate AS, while 49% had only one or two criteria met. DI was the most common parameter for defining moderate AS, employed in 93% of patients. Patients with area-based indices (i.e., AVA, AVAi, DI) had lower stroke volume index, lower mean gradients, lower peak velocities, and more morbidities in comparison to those flow-based definitions of severity (i.e., PV, MG). During a median follow-up of 5.7 years, overall survival was poor with all-cause mortality of 62.8%. Notably, there was no difference in the rates of mortality (range, 56.4 to 63.3%) or HF hospitalization (range, 28.9 to 32.2%) for groups defined by the five parameters, though patients with flow-based definitions more likely had AVR in follow-up.

Conclusions
Most patients with moderate AS meet the definition for severity with one or few criteria. Regardless of the method of definition for severity, a high rate of mortality and morbidity can occur in patients with moderate AS. Further study to optimize the clinical outcomes of patients with moderate AS is warranted.

Funding Acknowledgement
Type of funding source: Foundation. Main funding source(s): Minneapolis Heart Institute Foundation
Mitral annulus disjunction is highly prevalent in patients with Marfan syndrome and Loyes-Dietz syndrome
Authors: Chivulescu M , Krohg-Sorensen K , Scheirlynk E , Lindberg B , Dejgaard L , Lie O , Helle-Valle T , Skjolsvik E , Aabel E , Hunt T , Estensen M , Edvardsen T , Lingaas P , Haugaa K 
Published: November 2020

Abstract

Background
Mitral valve prolapse is a common finding in patients with Marfan and Loyes-Dietz syndrome. Mitral annulus disjunction (MAD), an atrial displacement of the hinge point of the mitral valve, has previously been associated with non-syndromic MVP and life-threatening ventricular arrhythmias.

Purpose
We aimed to assess the prevalence of MAD in patients with Marfan and Loyes-Dietz syndrome and relate the presence of MAD to mitral valve prolapse.

Methods
We included genotype positive patients with Marfan and Loyes-Dietz syndrome, and patients with Marfan syndrome fulfilling Revised Ghent Criteria. Mitral valve prolapse was defined as superior mitral leaflets' displacement ≥2mm beyond the mitral annulus. MAD was diagnosed by echocardiography and quantified as the distance from the ventricular myocardium to the hinge point of the posterior mitral leaflet (Figure, left panel).

Results
We included 111 patients with Marfan syndrome and 66 patients with Loyes-Dietz syndrome (age 26 [IQR, 13–39] years, 53% male). Mitral valve prolapse was observed in 54 (31%) and MAD in 74 (42%) patients. Longitudinal MAD distance was 8 (IQR, 6–10) mm. Forty-six (85%) patients with mitral valve prolapse had concomitant MAD, p&lt;0.001 (Figure, right panel).

Conclusion
Mitral valve prolapse was observed in one third of patients with Marfan and Loyes-Dietz syndrome. MAD was highly prevalent and found in 42% of all patients and in 85% of those with mitral valve prolapse. Presence of mitral valve prolapse in Marfan and Loyes-Dietz syndrome should raise awareness of MAD which may be of importance in follow-up and monitoring of these patients.

Funding Acknowledgement
Type of funding source: Public Institution(s). Main funding source(s): Health Authority of South Eastern Norway
Predictors of sudden cardiac arrest in adolescents with mitral valve prolapse: an analysis of the nationwide inpatient sample
Authors: Narasimhan B , Wu L , Lucas C.H , Bhatia K , Shah A , Kantharia B 
Published: November 2020

Abstract

Background
Mitral valve prolapse (MVP) is the most commonly encountered valvular pathology seen in 2–3% of the general population. Though traditionally regarded as a benign pathology, recent literature suggests that sudden cardiac death is significantly more common in these patients with estimates of 0.2–0.4%/year. The exact underlying mechanism of these higher rates of SCD remain poorly understood. In this study, we aim to identify predictors of sudden cardiac arrest (SCA) in an adolescent population.

Methods
We conducted a retrospective study using the AHRQ-HCUP National Inpatient Sample 2016-2017 for the years 2016-17. All patients (≤18 years) admitted with Mitral valve prolapse were identified using ICD-10 codes and further sub stratified based on presence or absence of sudden cardiac arrest (SCA). Baseline characteristics were obtained and multivariate regression analysis was utilized to identify potential predictors of SCA. Independent risk factors for in-hospital mortality were identified using a proportional hazards model. Complications were defined as per the Agency for Health Care Research and Quality guideline.

Results
We screened a total of 71,473,874 admissions in the NIS database to identify a total of 1,372 adolescent patients admitted with MVP in the years 2016–17. These patients were then sub-categorized based on presence or absence of SCA during the hospitalization. Our findings revealed that patients with SCA were generally slightly older (15y vs 13y, p=0.036, OR-1.1, p=0.007) and more likely female (83.3% vs 13%, p=0.227, OR – 3.55, p=0.57)). Interestingly, patients in the SCA cohort were noted to have almost 4 fold higher rates of Mitral regurgitation (66.6% vs 18.35%, p=0.008, OR-8.89, p=0.005) as well as family history of SCD (16.7% vs 4.1%, p=0.145, OR-4.65, p=0.14).

Conclusions
Presence of Mitral regurgitation and a family history of sudden cardiac death are associated with significantly higher rates of SCA in adolescent patients with mitral valve prolapse.
Predictors of SCA in Adolescent MVP

Funding Acknowledgement
Type of funding source: None