bluuebunny/crossref_metadata_2025 huggingface dataset:
Impact of new-onset left bundle branch block on clinical and echocardiographic outcomes after TAVR with SAPIEN-3 valve
Authors: Lak H , Sammour Y , Chahine J , Chawla S , Kadri A , Popovic Z , Tarakji K , Svensson L G , Reed G , Puri R , Krishnaswamy A , Kapadia S
Published: October 2021

Background

New left bundle branch block (LBBB) is a common finding after transcatheter aortic valve replacement (TAVR) that can result in worse outcomes after TAVR. We aim to investigate the impact of new-onset LBBB after TAVR using the SAPIEN-3 (S3) valve.

Methods

Consecutive patients who underwent transfemoral-TAVR with S3 valve between April 2015 and December 2018 were included. Exclusion criteria included pre-existing LBBB, right bundle branch block, left anterior hemiblock, left posterior hemiblock, wide QRS ≥120 msec, prior permanent pacemaker (PPM), and non-transfemoral access.

Results

Among 612 patients, 11.4% developed new-onset LBBB upon discharge. Implantation depth was the only predictor of new-onset LBBB (OR 1.294; 95% CI 1.121–1.493; p<0.001). The median (IQR) length of stay was longer with new-onset LBBB [3 (2–5) days vs. 2 (1–3) days; p<0.001]. New-onset LBBB was associated with higher thirty-day PPM requirement (18.6% vs. 5.4%; p<0.001) including those implanted after discharge (4.3% vs. 0.9%; p=0.02). There was no difference in 3-year all-cause mortality between both groups (30.9% vs. 30.6%; log-rank p=0.829). Further, new-onset LBBB was associated with lower left ventricular ejection fraction (LVEF) at both 30 days (55.9±11.4% vs. 59.3±9%; p=0.026) and 1 year (55±12% vs. 60.1±8.9%; p=0.002) despite no differences at baseline. These changes were still present when we stratified patients according to baseline LVEF (≥50% or <50%). We also noted higher mean LV end-diastolic volume index (51.4±18.6 vs. 46.4±15.1 ml/m2; p=0.036), and LV end-systolic volume index (23.2±14.1 vs. 18.9±9.7 ml/m2; p=0.009) with new-onset LBBB at 1 year. Lastly, there were significantly higher rates of heart failure readmissions at 1 year with new-onset LBBB (10.7% vs. 4.4%; log-rank p=0.033).

Conclusion

Among our cohort of S3 recipients, new-onset LBBB was associated with higher PPM requirement, worse LVEF, higher LV volumes and increased risk of heart failure hospitalizations. However, it did not affect mortality in the short-to-intermediate post-TAVR period.

Funding Acknowledgement

Type of funding sources: None. Figure 1. All-cause Survival
Transcatheter aortic valve implantation in degenerated trans-catheter and surgical bioprosthetic aortic valve
Authors: Chanchai R , Ancona M R , Ancona M , Montorfano M
Published: October 2021

Background

The moving forward indication of transcatheter aortic valve implantation (TAVI) to younger aortic valve stenosis (AS) patients might lead to degenerated trans-catheter heart valve (TAV) issues which need re-intervention. TAVI in a degenerated bioprosthetic surgical valve (SAV) is feasible. However, the results of TAVI-in-TAV when compare to TAVI-in-SAV have been rarely reported.

Purpose

The aims of this study is to compare device success, early safety events at 30 days, clinical efficacy events after 30 days, and time related valve safety events between TAVI-in-TAV and TAVI-in-SAV.

Methods

Retrospectively analysed data from 62 consecutive patients with degenerated TAV or SAV who received TAVI at our Scientific institute from January 2016 to June 2020.

Results

10 patients who received TAVI-in-TAV and 52 patients who received TAVI-in-SAV were included. The patient median age was 78 years and 60% was male. The median STS score was significantly higher in TAVI-in-TAV compared to TAVI-in-SAV groups; 7.80% vs. 3.30% respectively, p=0.006. The age of the first bioprosthetic was longer in TAVI-in-SAV compared to TAV-in-SAV group; 9.8 versus 5.3 years, respectively. All TAVI devices used in both groups were second generation. The device success rate, early safety at 30 days, clinical efficacy events at median 2-years follow up were comparable; 90% vs. 88.5%, 80% vs. 76.9%, 70% vs. 44.2%, in TAVI-in-TAV and TAVI-in-SAV groups respectively. All-cause mortality at 2-years follow up was comparable; 10% vs. 9.8% in TAVI-in-SAV and TAVI-in-SAV groups, respectively. Time related valve safety events at 2-years follow up was comparable; 30% vs. 26.9% in TAVI-in-TAV and TAVI-in-SAV groups respectively. Most valve safety events were related to residual high trans-aortic valve gradient which found only in small first bioprosthetic valve. The rate of new permanent pacemaker implantation was 16.7% in both groups. The coronary obstruction found was 19.2% in TAVI-in-SAV group.

Conclusions

TAVI-in-TAV is feasible and comparable on device success, immediate and 2-years follow up outcomes compared to TAVI-in-SAV. Larger studies with longer-term follow-up time are needed to confirm these results as well as the upstream management of AS patient with long life expectancy.

Funding Acknowledgement

Type of funding sources: None. Conclusion
Valve-in-valve transcatheter aortic valve replacement or re-surgical aortic valve replacement in degenerated bioprostheses: a systematic review and meta-analysis of short and mid-term results
Authors: Bruno F , Elia E , D'Ascenzo F , Marengo G , De Filippo O , Gallone G , Andreis A , Fortuni F , Salizzoni S , Rinaldi M , La Torre M , Conrotto F , De Ferrari G M
Published: October 2021

Introduction

Despite limited to short and mid-term outcomes, Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) has emerged as a less invasive alternative to redo surgery for high and intermediate-risk patients with good outcomes across different surgical risk profiles.

Purpose

The aim of the resent meta-analysis is to compare short and mid-term outcomes of VIV and surgical redo fo patients with a degenerative aortic bioprosthesis.

Methods

All studies comparing with multivariate adjustment between ViV TAVI and re-SAVR were screened. All-cause mortality at 30-day and at follow-up were the primary endpoints, while Valve Academy research Consortium (VARC) endpoints at 30 days including stroke, myocardial infarction (MI), major vascular complications, major bleeding, new onset atrial fibrillation (AF) and permanent pacemaker implantation (PPI) during the index hospitalization were the secondary endpoints. Subgroup analysis were performed according to the surgical risk. All the analyses were stratified according to the design of the study (observational vs propensity-matched study).

Results

We obtained data from 11 studies, encompassing 8570 patients, 4224 undergoing ViV TAVI and 4346 re-SAVR. Four studies included intermediate-risk patients and seven high-risk patients. Mean age was 76 and 71.5 years in the ViV and re-SAVR group respectively, with a 60.2% and 61.3% of male. For the ViV procedure, BE prostheses were used in the 49.6% of patients and SE prostheses in the 45.8%. The ViV group have higher prevalence of previous CAD (53.8% vs 41.1%) and CABG (35% vs 23.6%) and more history of HF (72.1% vs 65.6%), CKD (26.6% vs 14.8%) and COPD (25.4 vs 14.8%). 30-day all-cause and CV mortality were significantly lower in ViV (OR 0.43, 0.29–0.64 and OR 0.44, 0.26–0.73 respectively), while after a mean follow-up of 717 (180–1825) days, there were no difference between the two groups (OR 1.04, 0.87–1.25 and OR 1.05, 0.78–1.43 respectively). The result were consistent both in intermediate and high-risk classes. The risk of stroke (OR 1.03, 0.59–1.82), MI (OR 0.70, 0.34–1.44), major vascular complications (OR 0.92, 0.50–1.67) and permanent pacemaker implantation (OR 0.67, 0.36–1.25) at 30 days did not differ, while major bleedings and new onset atrial fibrillation were significantly lower in ViV patients (OR 0.41, 0.25–0.67 and OR 0.23, 0.12–0.42 respectively, all CI 95%).

Conclusions

In patients with a degenerated aortic bioprosthesis, ViV TAVI is associated with better short-term outcomes, including all-cause mortality, without any difference in all-cause and cardiovascular mortality at mid-term follow-up compared to surgical redo.

Funding Acknowledgement

Type of funding sources: None.
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

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<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<0.01).

Following TAVR, 355 patients (54.7%) had died after 64.2±31.9 months. Independent predictors of mortality were (para-)prosthetic regurgitation >mild at discharge (HR: 1.58, 95% CI: 1.21–2.06, p<0.001), male sex (HR: 1.57, 95% CI: 1.24–2.00, p<0.001), baseline NT-proBNP serum levels (graded into quartiles, HR: 1.31, 95% CI: 1.17–1.46, p<0.001), and diabetes (HR: 1.38, 95% CI: 1.08–1.76, p=0.011), but not time-dependent HVD (p>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

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>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

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<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

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<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<0.01), while they did not in case of residual postprocedural MR >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

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<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<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

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

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

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.
Prognostic role of right ventricular geometry and function in patients undergoing double valve surgery
Authors: Tse Y K , Yu Y J , Li H L , Wu M Z , Ren Q W , Chen Y , Yu S Y , Tse H F , Yiu K H
Published: October 2021

Introduction

Multiple valvular heart disease, a combination of stenotic and regurgitant lesions occurring on two or more valves, is a highly prevalent condition. For these patients, surgical correction is the only definitive treatment to improve prognosis, yet concomitant aortic and mitral (double) valve surgery is associated with poor post-operative outcomes. While current guidelines outline left ventricular dimensions and function as surgical triggers, little is known regarding the importance of right ventricular (RV) remodelling in these patients.

Purpose

We sought to evaluate the prognostic value of RV remodelling in patients undergoing double valve surgery.

Methods

RV remodelling was characterised by transthoracic echocardiography in 152 patients undergoing concomitant aortic and mitral valve replacement (n=118) or aortic valve replacement and mitral valve repair (n=34). Four patterns of RV remodelling were defined according to the presence of RV dilation (tricuspid annulus diameter>35mm) and RV systolic dysfunction (percentage RV fractional area change <35%): normal RV size and systolic function (pattern 1); dilated RV with normal systolic function (pattern 2); RV systolic dysfunction with normal RV size (pattern 3); and dilated RV with systolic dysfunction (pattern 4). Adverse events were defined as the composite of all-cause mortality and hospitalisation for heart failure.

Results

Overall, 62 (41%), 31 (20%), 35 (23%), and 24 (16%) patients were classified as RV remodelling patterns 1, 2, 3, and 4, respectively. Patients with advanced RV remodelling patterns were more frequently male, had worse renal function, and a higher EuroSCORE II. During a median follow-up of 43 months, 41 adverse events (22 heart failure hospitalisation and 19 deaths) occurred. Patients with patterns 3 and 4 RV remodelling had an increased risk of adverse events compared to pattern 1 (log-rank χ2 27.42; p<0.001; Figure 1). After adjustments for EuroSCORE II and significant tricuspid regurgitation, RV remodelling patterns 3 (Hazard Ratio [HR] 3.24, 95% Confidence Interval [CI] 1.27–8.24, p=0.014) and 4 (HR 6.18, 95% CI 2.49–15.32, p<0.001) were independently associated with poor post-operative outcomes. Importantly, RV remodelling patterns provided incremental prognostic value to EuroSCORE II (χ2 increased from 18 to 38, p<0.001).

Conclusion

In patients with concomitant aortic and mitral valve disease, RV remodelling is frequent and associated with poorer outcomes. Our study highlights the involvement of the RV in left-sided valvular heart disease and underlines the importance of preoperative assessment of RV geometry and function in patients undergoing double valve surgery.

Funding Acknowledgement

Type of funding sources: None. Figure 1
Artificial intelligence derived age algorithm after heart transplantation
Authors: Ozcan I , Toya T , Cohen-Shelly M , Ahmad A , Corban M T , Noseworthy P A , Kapa S , Lerman L O , Attia Z I , Friedman P A , Kushwaha S S , Lerman A
Published: October 2021

Background

An artificial intelligence (AI) algorithm detecting age from 12-lead ECG has been suggested to signal “physiological age” of the individual. Importantly, increased physiological age gauged by an increased difference between ECG-age and chronological age has been associated with higher risk of cardiac events in non-transplant population.

Purpose

We sought to investigate the validity of the AI-derived ECG-age algorithm in patients who underwent heart transplantation and its relationship to major adverse cardiovascular events (MACE).

Methods

A total of 489 consecutive patients who had undergone heart transplantation in our institution between 1994 and 2018 were studied. AI-ECG age was calculated by a previously-trained artificial intelligence (AI) algorithm using a 12-lead ECG per patient. ECGs used in the training process of the algorithm were excluded. The average of the ECG-ages within one year before and one year after heart transplantation was used to represent pre- and post-transplant ECG-ages. MACE was defined as any incidence of revascularization, re-transplantation, and death.

Results

Pre-transplant ECG-age (mean 63±10 years) correlated significantly with recipient chronological age (mean 50±13 years, r=0.57, p<0.0001), but this correlation between recipient and ECG-ages was weakened after transplantation (mean post-transplant ECG age of 55±10 years, r=0.34, p<0.0001). Interestingly, post-transplant ECG-age correlated significantly with donor age (mean ECG age of 55±10 years vs. mean donor age of 32±13 years, r=0.42, p<0.0001). During a median (IQR) follow-up of 9 (5, 14) years, 251 patients had MACE. Mean change in ECG age after transplantation compared to before was −8.8±12.7 years. Patients who had an increase in ECG-age after compared to before transplantation showed increased risk of MACE (HR: 1.53 [1.16, 2.01], p=0.002), independent of recipient and donor ages (adjusted HR: 1.68 [1.26, 2.25], p=0.001); whereas there were no significant differences in risk of MACE in patients who were transplanted with an older donor heart (HR: 1.07 [0.77, 1.50], p=0.66). In a Kaplan Meier survival analysis, those with increased ECG-age after transplantation had significantly lower MACE-free survival compared to those with decreased ECG-age. (Log-rank P=0.002; Wilcoxon P=0.001) (Figure)

Conclusion

Post-transplant ECG-age correlates more faithfully with the donor's than the recipient's chronological age, suggesting that ECG-age more closely reflects cardiac age than the patient age. Furthermore, ECG-age derived cardiac aging after transplantation is associated with higher risk of MACE.

Funding Acknowledgement

Type of funding sources: None.
Association between blood pressure classification using the 2017 American College of Cardiology/American Heart Association blood pressure guideline and hypertensive retinopathy
Authors: Seki H , Kaneko H , Matsuoka S , Itoh H , Yano Y , Morita K , Kiriyama H , Kamon T , Fujiu K , Michihaka N , Jo T , Takeda N , Morita H , Yasunaga H , Komuro I
Published: October 2021

Purpose

We aimed to explore the association of blood pressure (BP) classification using the 2017 American College of Cardiology/ American Heart Association Guideline and the prevalence of hypertensive retinopathy using a nationwide epidemiological database.

Methods

This study is a retrospective observational cross-sectional analysis using the health claims database of the JMDC between 2005 and 2020. We analyzed 280,599 participants who did not take anti-hypertensive medications. Each participant was categorized as having normal BP (systolic BP [SBP] <120 mm Hg and diastolic BP [DBP] <80 mm Hg; n=159,524); elevated BP (SBP 120–129 mm Hg and DBP <80 mm Hg; n=35,603); stage 1 hypertension (SBP 130–139 mm Hg or DBP 80–89 mm Hg; n=54,795); or stage 2 hypertension (SBP ≥140 mm Hg or DBP ≥90 mm Hg; n=30,677). Retinal photography at health check-up was classified as normal, grade 1, grade 2, grade 3, or grade 4 according to the Keith-Wagener-Barker system.

Results

Median (interquartile range) age was 46 (40–53) years, and 50.4% were men. Hypertensive retinopathy which was defined as ≥ Keith-Wagener-Barker system grade 1, was observed in 16,836 participants (6.0%). Multivariable logistic regression analysis showed that, compared with normal BP, elevated BP (odds ratio [OR] 1.30, 95% confidence interval [CI] 1.23–1.38), stage 1 hypertension (OR 1.71, 95% CI 1.64–1.79), and stage 2 hypertension (OR 4.10, 95% CI 3.93–4.28) were associated with higher prevalence of hypertensive retinopathy. Even among 92,121 participants without obesity, high waist circumference, diabetes mellitus, dyslipidemia, cigarette smoking, and alcohol drinking, multivariable logistic regression analysis showed that, compared with normal BP, elevated BP (odds ratio 1.34, 95% CI 1.19–1.51), stage 1 hypertension (OR 1.79, 95% CI 1.61–1.98), and stage 2 hypertension (OR 4.42, 95% CI 4.00–4.92) were associated with higher prevalence of hypertensive retinopathy. The association between BP category and hypertensive retinopathy was observed in all subgroups stratified by age or sex.

Conclusion

Our investigation showed that the prevalence of hypertensive retinopathy increased with the blood pressure category, suggesting that atherosclerotic change could start even in elevated BP and stage 1 hypertension.

Funding Acknowledgement

Type of funding sources: Public grant(s) – National budget only. Main funding source(s): This work was supported by grants from the Ministry of Health, Labour and Welfare, Japan (19AA2007 and H30-Policy-Designated-004) and the Ministry of Education, Culture, Sports, Science and Technology, Japan (17H04141).
Arterial stiffness and the risk of heart failure formation in rotational shift workers in the arctic
Authors: Shurkevich N , Vetoshkin A , Gapon L , Dyachkov S , Simonyan A
Published: October 2021

Aim

To investigate factors associated with arterial hypertension (AH) development, evaluate arterial stiffness (AS) and the risk of heart failure formation in rotational shift workers in the Arctic.

Methods

Within 6 days of September 2019, in the polar settlement of Yamburg (68 N), on the basis of Yamburggazdobycha LLC medical unit, 183 individuals (48.7±8.3 years), working rotating shifts (16.9±8.7 years) were enrolled via medical examination. Patients were divided into 2 groups according to the level of blood pressure (BP): Group 1 (Gr. 1) included 86 individuals with AH of 1,2 stages; Group 2 (Gr. 2) comprised 97 individuals with BP <140/90 mm Hg. Ultrasound examination of carotid arteries (CA) was performed, Peterson's elastic modulus (Ep), β-stiffness index, cardio-ankle vascular index (CAVI), pulse wave velocity (PWV) were determined; ABPM was performed; EchoCG was conducted using calculation of probability for heart failure with preserved ejection fraction (HFpEF) by the H2FPEF score (Heavy; Hypertensive; Atrial Fibrillation; Pulmonary Hypertension; Elder; Filling Pressure); blood lipid spectrum, inflammatory markers, brain natriuretic peptide were determined.

Results

In Gr.1 vs Gr.2, elevated levels of left CAVI (7.9 vs 7.4) (p=0.022) and right CAVI (7.9 vs 7.5) (p=0.045) were registered; PWV: 13.8 m/s vs 12.6 m/s (right), (p<0.001) and 13.9 m/s vs 12.6 m/s (left), (p<0.001); triglycerides, (p=0.03); very low density lipoprotein cholesterol, (p=0.054); homocysteine, (p=0.025). Probability of HFpEF by the H2FPEF score was higher in Gr.1 than Gr.2 (p<0.001). According to logistic regression analysis, data of odds ratio (OR) determined the risk of AH developing with increasing of PWV (OR=1.444); 24-hour diastolic blood pressure variability (DBPV24) (OR = 1.164); probability of HFpEF by the H2FPEF score (OR = 1.677). Relationships of Peterson's elastic modulus (Ep) of common carotid artery (CCA) with left ventricular myocardial mass (LVMM) (r=0.39), (p<0.01), LVMMI (r=0.39), (p<0.01), probability HFpEF by H2EPEF score (r=0.27), (p<0.01); β-stiffness index of CCA with LVMM (r=0.25), (p<0.01) were found.

Conclusion

Interrelation of AH with PWV (OR=1.444), DBPV24 (OR=1.677), probability of HFpEF by the H2FPEF score (OR = 1.677) should be considered for prognostication of the risk of AH with HFpEF formation in rotational shift workers in the Arctic. Associations of AS with LVMM and LVMMI, HFpEF signs may indicate processes of simultaneous interconnected formation of arterial and cardiac stiffness.

Funding Acknowledgement

Type of funding sources: None.
Age differences in the association between arterial velocity pulse index and muscle sympathetic nerve activity in hypertensive patients
Authors: Sugimoto H , Murai H , Hirai T , Hamaoka T , Mukai Y , Tokuhisa H , Usui S , Sakata K , Kawajiri M , Takamura M
Published: October 2021

Background

Increased arterial stiffness characterize by aging. It is reported that age-related increases in muscle sympathetic nerve activity (MSNA) may be one of contributing factor for arterial stiffness. Arterial reflected wave was composed of SNA and aging. Increased arterial reflected wave partly plays an important role in blood pressure. Recently, we reported that arterial velocity pulse index (AVI), a novel index of arterial reflected waves, was associated with MSNA in hypertensive patients. It is still uncertain the effect of age on the association between AVI and SNA in hypertensive patients.

Method

Patients with essential HT and matched non-hypertensive control subjects were included in this study. HT was diagnosed as systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥90 mmHg. AVI was measured from left upper arm by NAS-1000. SNA was evaluated by direct recording of muscle sympathetic nerve activity (MSNA) from peroneal nerves.

Results

45 HT patients and 46 control subjects were included. Age, SBP and DBP were significantly increased in HT group compared to control (Age 63±14 vs 42±16 years, p<0.001; SBP 144±16 vs 115±9 mmHg, p<0.001; DBP 80±14 vs 67±9 mmHg, p<0.001). MSNA and AVI were significantly increased in HT group compared to control (MSNA 34±10 vs 25±8 bursts/min, p<0.05; AVI 28±9 vs 17±5, p<0.05). AVI was significantly correlated with MSNA, age, and SBP in HT group. HT group was divided into two groups according to their age (group 1, age ≤63 N=21, group 2, age ≥64 N=26). AVI in group 1 showed correlation with MSNA (r=0.59, p<0.05), but no correlation was seen in group 2. However excluded SBP>160 mmHg subjects in group 2, significant correlation was clarified between AVI and MSNA (r=0.62, p<0.05).

Conclusion

The relationship between AVI and MSNA in HT patients is preserved regardless of aging, however, high blood pressure over 160mmHg might obscure its correlation. These results indicate that AVI is useful to estimate sympathetic nerve activity in high aging HT patient treated <160 blood pressure.

Funding Acknowledgement

Type of funding sources: None.
Strain analysis by two-dimensional speckle tracking echocardiography for evaluating left ventricular systolic function in women with pre-eclampsia
Authors: Giorgione V , O'Driscoll J , Di Fabrizio C , Frick A , Cauldwell M , Khalil A , Thilaganathan B
Published: October 2021

Background

Previous echocardiographic studies have shown that most women affected by pre-eclampsia present with mild-to moderate diastolic dysfunction and left ventricle remodelling with a preserved systolic function. These alterations appear more severe when pre-eclampsia develops before 34 weeks of gestation.

Purpose

The aim of this study is to compare left ventricular systolic (LV) function by using 2-D speckle tracking echocardiography in women with early-onset and late-onset pre-eclampsia.

Methods

In this single-centre prospective longitudinal study, 119 women with a diagnosis of pre-eclampsia underwent standard trans-thoracic echocardiography (TTE) in the immediate peripartum period from February 2019 to December 2020. LV function was assessed using two-dimensional speckle-tracking strain imaging on 4-chamber views with a frame rate of 60–90 frames/second. Strain analysis quantification was performed using a commercial software.

Results

Pre-eclampsia was diagnosed before and after 34 weeks in 37.3% (44/119) and 62.7% (74/119) of the patients, respectively. Maternal characteristics, such as maternal age, body mass index, pre-existing hypertension and nulliparity, did not show any significant difference between the two groups. Although LV remodelling/hypertrophy and diastolic dysfunction occurred more often in early-onset pre-eclampsia compared to late-onset (65.9% vs 60.8% and 59.1% vs 51.4%, respectively), this difference was not statistically significant (p=0.580 and p=0.414, respectively). Similarly, LV mass index was 80.1±16.3 in pre-eclampsia <34 and 79.1±15 >34 (p=0.715) and E/e' was 7.8±1.9 and 7.6±1.7 (p=0.424). However, global longitudinal strain (GLS) was significantly lower (−16.4±2.4 vs −17.6±2.4, p=0.030) and apical rotation was higher (11.1±5.9 vs 8.7±4.7, p=0.019) in early-onset pre-eclampsia. A positive weak correlation has been found between GLS and difference in days from pre-eclampsia diagnosis to delivery (r=0.2, p=0.002).

Conclusions

Lower GLS in women affected by early-onset pre-eclampsia compared to late-onset pre-eclampsia might be useful to detect sub-clinical LV systolic impairment. Although further studies are needed, this sensitive marker may have a role in identifying women at risk of preterm delivery and/or severe maternal morbidity in the peripartum period.

Funding Acknowledgement

Type of funding sources: Public grant(s) – EU funding. Main funding source(s): Veronica Giorgione and Carolina Di Fabrizio have received funding from the European Union's Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No 765274 (iPLACENTA project).