bluuebunny/crossref_metadata_2025_split huggingface dataset:
Rate, correlates, and outcomes of hemodynamic valve deterioration after transcatheter aortic valve replacement
Authors: Nitsche C , Mutschlechner D M , Koschutnik M K , Dona C D , Dannenberg V D , Kammerlander A K , Winter M P W , Goliasch G G , Hengstenberg C H , Mascherbauer J M 
Published: October 2021

Abstract

Objectives
Treatment expenditure of transcatheter aortic valve replacement (TAVR) to younger individuals may potentially be limited by valve durability. Long-term hemodynamic performance of transcatheter aortic valves is not well documented. This study sought to determine the incidence, predisposing factors and outcomes of hemodynamic valve deterioration (HVD) after TAVR.

Methods
Consecutive patients undergoing TAVR between May 2007 and December 2018 (67.0% Sapien, 14.6% Evolut, 6.8% Acurate, 6.8% Portico, 4.8% other) were prospectively studied. Baseline assessment included echocardiography, laboratory, and clinical assessment. Echocardiographic and laboratory follow-up after TAVR was performed prior to discharge, at 3 and 12 months, and yearly thereafter. HVD was defined by Doppler assessment according to Valve Academic Research Consortium 3 criteria as a ≥10 mm Hg increase in mean gradient to ≥20 mm Hg OR worsening of (para-)prosthetic regurgitation ≥1/3 class to ≥moderate. The primary endpoint was the incidence of HVD. All-cause mortality served as secondary endpoint. Multivariate cox regression was used for outcome analysis.

Results
649 patients (82.2±6.7 y/o, 55.5% female, EuroSCORE II 4.4±1.0) were analyzed. Among survivors with available echo data from ≥2 follow-ups (n=382), the incidence of HVD was 6.8% (n=26; 4.1% per valve-year), with no difference between valve types. Modes of HVD were stenosis (n=8), regurgitation (n=14), and both (n=4). Median time to HVD was 14.2 months (interquartile range, 9.4 to 35.0 months), and was significantly shorter in patients in the highest age quartile (Q4 vs. Q1–3: log-rank, p&lt;0.01, Figure). Also, increased age was the only factor that independently predisposed for HVD (Q4 vs. Q1–3: adjusted hazard ratio [adj HR]: 2.86, 95% confidence interval [CI]: 1.30–6.30, p&lt;0.01).
Following TAVR, 355 patients (54.7%) had died after 64.2±31.9 months. Independent predictors of mortality were (para-)prosthetic regurgitation &gt;mild at discharge (HR: 1.58, 95% CI: 1.21–2.06, p&lt;0.001), male sex (HR: 1.57, 95% CI: 1.24–2.00, p&lt;0.001), baseline NT-proBNP serum levels (graded into quartiles, HR: 1.31, 95% CI: 1.17–1.46, p&lt;0.001), and diabetes (HR: 1.38, 95% CI: 1.08–1.76, p=0.011), but not time-dependent HVD (p&gt;0.05, Figure).

Conclusion
This study reports good hemodynamic performance of transcatheter aortic valves up to 8 years following intervention. The incidence of HVD, which may develop over time – especially in the elderly –, is low and does not impact survival. Conversely, (para-)prosthetic regurgitation early after TAVR conveys detrimental prognostic implications and needs to be avoided – particularly in younger patients.

Funding Acknowledgement
Type of funding sources: None. Hemodynamic valve deterioration in TAVR
Late Clinical and Hemodynamic Outcomes in patients with degenerated bioprosthetic aortic valves undergoing transcatheter valve-in-valve implantation
Authors: Abushouk A I , Abdelfattah O , Saad A , Gad M M , Reed G W , Puri R , Yun J , Vargo P R , Weiss A , Burns D , Popovic Z , Harb S C , Krishnaswamy A , Svensson L G , Kapadia S R 
Published: October 2021

Abstract

Background
Clinical studies have shown promising early outcomes for valve-in-valve transcatheter aortic valve implantation (ViV-TAVI); however, the late outcomes of this procedure remain under-investigated.

Purpose
We performed the present analysis to assess the late clinical and hemodynamic outcomes of ViV-TAVI in patients with degenerated bioprosthetic aortic valves.

Methods
A comprehensive chart review was performed for eligible patients to retrieve data on procedural characteristics, admission details following the procedure, and echocardiographic parameters. Clinical outcomes included all-cause mortality, heart failure hospitalization and structural valve deterioration (SVD), as defined by VARC-II criteria, up to 5 years of follow-up. To assess the trends in mean and peak transvalvular gradients, data from the follow-up echocardiographic reports were analyzed using Syngo Dynamics imaging software.

Results
A total of 188 patients were included with a mean age of 75.8±10.4 years. Balloon- and self-expandable valves were used in 155 (82.4%) and 33 (17.6%) patients, respectively. At 30 days, 3 (1.6%) patients died and 8 (4.2%) required hospitalization for heart failure, while at 5 years, both events were recorded in 29 (15.4%) and 37 (19.7) patients, respectively. Kaplan-Meier survival analysis showed that patients with smaller surgical valves (internal diameter ≤21 mm) had a significantly higher mortality rate (log-rank p=0.021) than those with larger valves; however, no significant difference (log-rank p=0.59) was detected between different transcatheter valves (self vs. balloon-expandable). Three patients underwent re-intervention, performed via a transcatheter approach. Further, assessment of follow-up echocardiographic reports revealed 9 (4.8%) cases of SVD, as well as stable mean (16.3±6.9 at discharge and 16.9±11.3) and peak (30.3±12.1 at discharge and 30.7±18.4 at 5 years) transvalvular gradients. No difference (p&gt;0.05) was observed based on transcatheter valve type or surgical valve internal diameter in terms of mean and peak transvalvular gradients throughout the follow-up period.

Conclusion
The present study showed good clinical outcomes among patients undergoing VIV-TAVI, with stable VIV performance over a five-year period. Future long-term studies are warranted to analyze the predictors of outcomes following ViV-TAVI and explore the role of this treatment option in the life-long management of aortic stenosis.

Funding Acknowledgement
Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Jennifer and Robert McNeil Donation to the Heart, Thoracic, and Vascular Institute at Cleveland Clinic. Figure 1
Cerebrovascular events after transcatheter mitral valve repair or guideline-directed medical therapy in patients with mitral regurgitation and heart failure in the COAPT trial
Authors: Vincent F , Redfors B , Kotinkaduwa L N , Kar S , Lim D S , Mishell J M , Whisenant B K , Lindenfeld J , Abraham W T , Mack M J , Stone G W 
Published: October 2021

Abstract

Background
Our knowledge regarding the risk of cerebrovascular events (CVE) in patients with heart failure (HF) and severe secondary mitral regurgitation (SMR) treated by transcatheter mitral valve repair (TMVr) is limited.

Purpose
To examine the incidence, predictors, timing, and prognostic impact of CVE in patients with heart failure and SMR treated with TMVr vs guideline-directed medical therapy (GDMT) alone.

Methods
In the COAPT trial, 614 patients with HF with moderate-to-severe or severe SMR were randomized to TMVr with the MitraClip + GDMT vs GDMT alone. After 2 years, patients who were randomized to GDMT alone could crossover and undergo TMVr. CVE (defined as stroke or TIA) were adjudicated by an independent clinical events committee.

Results
A total of 43 CVE occurred in 42 patients within 3-year follow-up (34 strokes and 9 TIAs; 1 patient had both). CVE occurred in 10.0% (n=20) of patients randomized to TMVR and 11.3% (n=22) of patients randomized to GDMT alone (p=0.53) (Figure). Of the 22 CVE in the GDMT alone group, 3 occurred after the patient had crossed over to TMVr. The incidence rates in the TMVr and GDMT groups were similar within the first 3 months (incidence rate ratio [IRR] 0.78, 95% CI 0.17–3.48, p=0.74) and between 3 months and 3 years (IRR 0.83, 95% CI 0.43–1.60, p=0.58) after randomization. After multivariable adjustment, baseline estimated glomerular filtration rate (eGFR) was associated with CVE in the overall population (HR per 5 ml/min increase in eGFR 0.91, 95% CI 0.84–0.99, p=0.03). Peripheral vascular disease was associated with CVE in patients treated by GDMT (HR=3.21, 95% CI [1.35, 7.67]) but not TMVr (HR 0.53 95% CI 0.12–2.24; p-interaction=0.04). In contrast, baseline chronic oral anticoagulation use was associated with a reduced risk of CVE in patients in the TMVr group (HR 0.18, 95% CI 0.05–0.63) but not in the GDMT alone group (HR 1.66, 95% CI 0.70–3.94; p-interaction=0.004). In a time-adjusted multivariable analysis, CVE was associated with a higher risk of death (HR 2.51, 95% CI 1.54–4.08; p=0.0002), a risk that was marked in the first 30 days after the event (HR 14.21, 95% CI 7.30–27.97, p&lt;0.0001), and declined thereafter (HR 1.37, 95% CI 0.72–2.59, p=0.34).

Conclusions
In patients with HF and severe SMR, CVE at 3 years was not infrequent, increased linearly over time, was similar after treatment with the MitraClip and GDMT alone, and was associated with a marked increase in all-cause death. Whether anticoagulation is especially effective at preventing CVE in patients treated by TMVr, as suggested by this report, warrants further study.

Funding Acknowledgement
Type of funding sources: Private company. Main funding source(s): Abbott Figure 1
Impact of the cardio-hepatic syndrome on outcomes after transcatheter mitral valve edge-to-edge repair
Authors: Stolz L , Orban M , Karam N , Lubos E , Wild M , Praz F , Braun D , Doldi P , Tence N , Hagl C , Mayerle J , Naebauer M , Kalbacher D , Massberg S , Hausleiter J 
Published: October 2021

Abstract

Background
The prognostic value of impaired liver function in the presence of moderate-to-severe and severe mitral regurgitation (MR), also called cardio-hepatic syndrome (CHS), for outcomes in patients undergoing transcatheter edge-to-edge repair (TEER) has not been studied yet.

Purpose
In this work, we aimed at identifying the prognostic impact of the CHS on two-year all-cause mortality in patients undergoing TEER compared to established risk factors. Furthermore, we evaluated the change in hepatic function after TEER.

Methods
Hepatic function was assessed by laboratory parameters of liver function (bilirubin, gamma glutamyl transferase [GGT], alkaline phosphatase [AP], aspartate and alanine aminotransferase [AST and ALT]). We defined CHS as elevation of at least two out of three laboratory parameters of hepatic cholestasis (bilirubin, GGT, AP). The impact of CHS on two-year mortality was evaluated using a proportional hazards Cox model. The change in hepatic function after TEER was evaluated by repeat laboratory testing at follow-up.

Results
We included 1083 patients who underwent TEER for highly symptomatic primary or secondary MR at four high volume academic European centers between 2008 and 2019. In 66.4% of patients, we observed elevated levels of either bilirubin, GGT or AP. CHS was present in 23% of patients and showed strong association with a reduced two-year survival (52.9% vs. 87.0% in patients without CHS, p&lt;0.01). In a multivariate Cox regression model, CHS was identified as a strong and independent predictor of increased two-year mortality (hazard ratio 1.49, p=0.03). In patients with successful MR reduction ≤2+ (90.7% of patients), parameters of hepatic function significantly improved from baseline to follow-up (−0.2 mg/dl for bilirubin; −21 U/l for GGT, respectively, p&lt;0.01), while they did not in case of residual postprocedural MR &gt;2+.

Conclusions
CHS can be observed in up to 25% of patients undergoing TEER and is associated with impaired two-year survival rates. Successful TEER is associated with decreased levels of hepatic enzymes at follow-up evaluation.

Funding Acknowledgement
Type of funding sources: None. Cardio-hepatic syndrome TEER
MitraClip NTR vs XTR system for transcatheter tricuspid valve repair of tricuspid regurgitation
Authors: Velichkov M , Otto S , Hamadanchi A , Schulze P C , Moebius-Winkler S 
Published: October 2021

Abstract

Background
Transcatheter tricuspid valve repair (TTVr) is a novel modality for treatment of severe tricuspid regurgitation (TR) in patients at high surgical risk. So far, the most frequently used system is the MitraClip® providing two different clip types (NTR vs XTR).

Purpose
To compare XTR vs NTR clip systems for TTVr regarding safety, feasibility, and effectiveness.

Methods
35 consecutive high-risk patients (78.4±7.9 years, EUROScore II 10.7±10.8%, STS Score 7.9±4.1) with symptomatic TR were treated using the MitraClip® system between 2017–2020. with an NTR (N=18, 51.4%) or XTR (N=17, 48.6%) system. The primary outcome was successful TTVr with TR reduction of ≥1 grade with no mortality, single leaflet device attachment (SLDA), or conversion to surgery until hospital discharge. At 30-day follow-up, TR severity grade and NYHA functional class were assessed.

Results
We found more severe initial TR grades in the XTR group compared to the NTR group expressed with wider TR V. contracta (14.8±4.3 vs 11.1±3.8 mm, p=0.011), larger EROA (0.99±0.4 vs 0.72±0.3 cm2, p=0.032), wider coaptation depth (9.6±2.8 vs 7.3±0.4 mm, p=0.036) and V. cava inferior (30.7±3.6 vs. 25.8±6.4 mm in NTR, p=0.013). 5 patients (29.4%) in the XTR and 3 patients (16.7%) in the NTR group presented initially with torrential TR. No significant differences were observed for clinical characteristics, comorbidities, co-medication, laboratory parameters or initial NYHA functional class (3.0±0.5 in NTR vs 3.2±0.4 in XTR, p=0.45). TTVr was safe with no intraprocedural deaths, emergency surgery or major vascular complications. Duration of the procedure and fluoroscopy did not differ. Both, NTR and XTR system led to procedural success in 72.2% (N=13) and 76.5% (N=13), respectively. At discharge, a significant reduction of initial TR grade was observed in both groups (2.4±0.9 in NTR and 2.3±0.9 in XTR, p&lt;0.001) with a tendency of greater mean reduction in the XTR group (1.9±1.0 vs. 1.3±0.9, p=0.09). All 5 patients with torrential TR in the XTR group (100%) and just 1 patient (33.3%) in the NTR group achieved the primary outcome. At 30-day follow-up, overall SLDA rate was 22% vs 17.6% for NTR and XTR, respectively. However, these cases were attributed to very high risk patients with poor anatomy. Mortality rate was 11.1% in NTR vs 5.9% in XTR group (p=0.59). Achieved reduction of TR was maintained in both groups (2.6±0.9 in NTR and 2.8±0.9 in XTR, p&lt;0.001). Also, improvement of NYHA functional class was seen (2.5±0.5, p=0.001 in NTR and 2.9±0.6, p=0.055 in XTR).

Conclusion
MitraClip® NTR and XTR systems for TTVr of severe TR in high-risk patients are safe and effective leading to a significant reduction of TR and clinical improvement. The XTR system seems to allow successful treatment of more severe TR stages compared to NTR.

Funding Acknowledgement
Type of funding sources: None.
First results of a regenerative transcatheter heart valve implant from autologous tissue in a long-term animal model
Authors: Kiekenap J , Sun X , Hultsch J , Dietrich T , Oetvoes J , Schmidt T , Reiter K , Kargin H , Emeis J , Berger F , Schmitt B 
Published: October 2021

Abstract

Background
The perfect heart valve replacement remains to be found regarding longevity, freedom of anticoagulation and availability in each size.

Purpose
Examination of a new technique for a regenerative, immunocompatible, transcatheter pulmonary valve implant from autologous pericardium was performed in an adult sheep model.

Methods
For each valve implant a pericardial patch was harvested by left antero-lateral mini-thoracotomy, placed on one of two slightly different shaped moulds either made of acrylic glass (AG) or printed in a 3D Printer (3D) and transferred into a container filled with a biological crosslinking agent at a non-toxic concentration to stabilize the given shape. After a median of 3 days (d) they were unpacked, sewn into a self-expandable nitinol stent with a diameter of 26 or 30mm and implanted via the jugular vein into pulmonary valve position of the same animal using a custom-made delivery system (1). Three groups (Gr) were planned: Gr 1) 4 animals with at least 6 d of crosslinking and AG mould; Gr 2) 5 animals with at least 3 d of crosslinking and AG mould; Gr 3) 6 animals with at least 3 d crosslinking and 3D mould. Follow ups (FU) were performed every 3 months (mo) evaluating valve function by intracardiac echocardiography (ICE) and cardiac MRI for up to 20.5 mo. All experiments were approved and conducted according to German federal law.

Results
In 11 of 13 animals minimally-invasive implantation was successful. One animal died because of ventricular fibrillation, in the other the implant dislocated into the right ventricle, so it had to be sacrificed. Direct post-implantation valve insufficiency was evaluated in 9 animals using ICE or angiography. In Gr 1 insufficiency was non-existent (n=2), in Gr 2 moderate or severe (n=2) and in Gr 3 non-existent or mild (n=5). Long term function as shown in figure 1 decreased rapidly in Gr 1 and 2 with median MRI regurgitation fractions (RF) in Gr 1 of 31% at 3 mo (n=3), 41% at 6 mo (n=3), 48% at 9 mo (n=2), 47% at 12 mo (n=3) and in Gr 2 of 43% at 3 and 54% at 6 mo (n=1) after implantation. Median RF in Gr 3 was small with 9% at 3 mo (n=4), 8% at 6 mo (n=3), 8% at 9 mo (n=3), 12% at 13 mo (n=3), 8% at 17 mo (n=2) and 20.5 mo (n=2). We never witnessed valve stenosis in any group at any point in time.

Conclusion
Gr 3 showed promising results regarding long time function of the implant which encourages further research with higher validity. The reason for failing of Gr 1 and 2 remains a topic of discussion. Regardless, valuable experience was gained in crafting and conducting the implantation of this new regenerative heart valve implant.

Funding Acknowledgement
Type of funding sources: Public grant(s) – National budget only. Main funding source(s): EXIST research transfer program of the federal ministry of education and research
Transcatheter paravalvular leak closure is an effective alternative to surgical repair with respect to 5-year outcomes
Authors: Moeliker L M , Nijenhuis V J , Ten Berg J M , Swaans M J , De Kroon T L , Heijmen R H , Agostoni P , Sonker U , Timmers L , Van Kuijk J P 
Published: October 2021

Abstract

Introduction
Paravalvular leakage (PVL) is a relatively common complication of heart valve replacement, associated with heart failure and increased mortality. Transcatheter PVL closure may be a promising alternative to surgical repair, especially in high-risk patients.

Purpose
Assessment of safety and efficacy of transcatheter PVL closure compared to surgical repair.

Methods
This is a retrospective single-centre study including all consecutive patients who underwent either transcatheter PVL closure between January 2013 and December 2020, or surgical repair between March 2015 and December 2020. Primary endpoints were 5-year all-cause mortality and the composite of 5-year cardiovascular mortality and rehospitalization for the underlying condition. Secondary endpoints were technical success and individual patient success at one year according to the PVL Academic Research Consortium.

Results
Of the 129 patients included, 85 went for transcatheter repair and 44 went for surgical repair. As compared to surgical repair, patients undergoing transcatheter PVL closure were older (71 years vs. 64,5 years; p≤0,01) and more symptomatic (NYHA class III & IV; 76,5% vs. 59,1%; p=0,04). At 5 years, transcatheter PVL closure was comparable to surgery in terms of the primary composite endpoint (HR: 1,20; 95% CI: 0,68–2,13; p=0,54), all-cause mortality (HR: 1,70; 95% CI: 0,82–3,50; p=0,15) and rehospitalization for the underlying condition (HR: 1,12; 95% CI: 0,54–2,89; p=0,780). Rates of technical success (92,9% vs. 95,5%; p=0,58) and individual patient success at one year (70,6% vs. 77,3%; p=0,87) were similar between transcatheter PVL closure and surgery respectively. Transcatheter PVL closure was associated with shorter in-hospital stay (7 days vs. 14 days; p≤0,01).

Conclusion
These findings support the use of transcatheter closure of PVL, especially in high-risk patients. Long term survival remains temperate in these challenging patients.

Funding Acknowledgement
Type of funding sources: None.
Nutrition and frailty status of patients undergoing cardiovascular surgery and its association with postoperative outcomes
Authors: Patricio M D , Lagos T B , Tan A D , Tortosa C J , Permejo C C 
Published: October 2021

Abstract

Background
Malnutrition is a component of Frailty Syndrome characterized by weakness, poor nutritional status and reduced cognitive function. Frailty has been recognized to adversely affect post Cardiovascular Surgery outcomes in the elderly. In developing countries, Frailty can occur in younger patients from Rheumatic Heart Disease and earlier onset of Atherosclerotic Cardiovascular Disease. There is limited data on frailty in the young.

Methods
Malnutrition and Frailty were assessed preoperatively in 111 adult patients undergoing Cardiovascular Surgery from October 2020 to February 2021. Nutrition Risk Screening Tool (NRS) and Clinical Frailty Scale (CFS) were used for assessment respectively. Their in-hospital postoperative outcomes was then observed.

Results
There were 57 patients (51%) diagnosed with malnutrition, 26 (23%) of which were also Frail. Advanced age, Rheumatic Heart Disease, Heart Failure and Chronic Kidney Disease was significantly higher in malnutrition and frail group. After multivariate analysis, mortality rate (odds ratio [OR] 7.8; 95% confidence interval [CI]: 1.45 - 41.91; P=.017), prolonged hospitalization (OR: 5.96; 95% CI: 2.14–16.53; P=.001), mechanical ventilation (OR: 7.56; 95% CI: 1.81–31.62; P=.006) and nosocomial infections (OR: 13.57; 95% CI: 4.41–41.76; P≤.001) were found higher in patients with malnutrition and frailty.

Conclusion
Evaluation of nutrition and frailty status using NRS and CFS was helpful in predicting postoperative outcomes. With a significant number of this population having Malnutrition and Frailty, there is a need to strengthen clinical pathways on perioperative nutrition and rehabilitation with the possibility of improving Cardiovascular Surgery outcomes.

Funding Acknowledgement
Type of funding sources: None.