bluuebunny/crossref_metadata_2025_split huggingface dataset:
Large multicenter evaluation of clinical outcomes of transcatheter aortic valve implantation in different age groups: results from the Israeli TAVI registry
Authors: Maller T , Jubeh R , Perel N , Barbash I M , Segev A , Kornowski R , Vaknin Assa H , Finkelstein A , George J , Perlman G , Guetta V , Asher E , Karameh H , Glikson M , Dvir D 
Published: October 2022

Abstract

Introduction
Transcatheter aortic valve implantation (TAVI) is becoming the preferred treatment for elderly patients with severe aortic stenosis. Clinical outcomes of these patients according to different age groups and especially in the very old population are under reported.

Purpose
To describe clinical characteristics at baseline, according to different age groups, and to compare clinical outcomes in the very old population with other patients undergoing the procedure.

Methods
Data was extracted from the Israeli National TAVI Registry. Clinical outcomes in very old patients (above the age of 90 years) were compared with younger patients. Multivariable analysis for 30-day and 1-year mortality were performed. Procedural complication was defined as one or more of the following: need for permanent pacemaker, major vascular complication, severe acute kidney injury and major stroke.

Results
A total of 5,936 patients who underwent TAVI from 2008 to 2021 were analyzed (age 81.6±7.1 years, 50.6% female). Patients older than 90 years of age had more comorbidities than the younger population (STS score for mortality 6.4%±3.8% vs. 4.1%±4.8%, p&lt;0.001). Independent correlates for 30-day mortality included STS score (OR=1.01, 95% CI [1.03–1.13], p&lt;0.001) and procedural complication (OR=4.29, 95% CI [2.24–8.20], p&lt;0.0001). Independent correlates for 1-year mortality included chronic obstructive pulmonary disease (OR=1.83, 95% CI [1.28–2.60]; p=0.001), atrial fibrillation (OR=1.71, 95% CI [1.31–2.23]; p&lt;0.001 (STS score); OR=1.13 95% CI [1.09–1.18]; p&lt;0.001), and procedural complication) OR=2.58, 95% [1.89–3.50]; p&lt;0.001).

Conclusions
Although older patients undergoing TAVI had a higher risk profile, short- and long-term survival of these patients were associated significantly more with procedural complications than with patient age. It seems that extreme patient age alone should not be viewed as a consideration for not performing valve replacement, as long as the risk for procedural complications does not seem to be severely elevated.

Funding Acknowledgement
Type of funding sources: None.
Predictors and outcomes of acute, sub-acute and early stroke following transcatheter aortic valve implantation
Authors: Van Nieuwkerk A C , Alfonso F , Tchetche D , De Brito Jr F S , Barbanti M , Latib A , Kornowski R , D'Onofrio A , Ribichini F , Mehran R , Delewi R 
Published: October 2022

Abstract

Background
Stroke is one of the most devastating complications after transcatheter aortic valve implantation (TAVI). The recent third Valve Academic Research Consortium (VARC-3) proposes new stroke terminology according to time between TAVI and stroke onset.

Purpose
We aimed to identify predictors and assessed mortality in patients undergoing transfemoral TAVI complicated by acute, sub-acute and early stroke.

Methods
Patients undergoing transfemoral TAVI were included in a global patient level database. Acute stroke was defined as stroke occurring ≤24 hours after the index procedure. Sub-acute stroke was defined as stroke occurring between &gt;1 day and ≤30 days and early stroke as &gt;30 and ≤365 days following TAVI, according to VARC-3. We identified predictors for these complications using multivariate logistic regression analysis and assessed mortality outcomes in these patients.

Results
A total of 11230 patients underwent transfemoral TAVI. Mean age was 81.5±7.0 years, 58% was female and median STS-PROM score was 6.5% (4.0%-13.2%). A total of 405 (3.6%) experienced stroke during the first year after TAVI. Of these 93 (23%) had acute stroke, 195 (46%) sub-acute stroke and 117 (27%) early stroke. One year mortality was highest after acute stroke (56.9%), followed by sub-acute stroke (41.7%), and early stroke (29.0%), but one-year mortality in all stroke patients was higher than in non-stroke patients (40.5% vs 15.8%, p&lt;0.001). Glomerular filtration rate was an independent predictor for acute stroke (odds ratio [OR] 0.9, 95% confidence interval [CI] 0.9–1.0, p=0.03). Previous cerebrovascular events independently predicted sub-acute stroke (OR 2.1, 95% CI 1.4–3.1, p=0.001). Independent predictors for early stroke were age (OR 1.0 per year, 95% CI 1.0–1.0, p=0.04) and peripheral vascular disease (OR 2.0, 95% CI 1.4–3.0, p&lt;0.001).

Conclusions
Patients undergoing transfemoral TAVI complicated by stroke showed higher one-year mortality than non-stroke patients. Earlier timing of post-TAVI stroke was associated with increased mortality. Acute stroke was predicted by renal impairment; sub-acute stroke by previous cerebrovascular events and early stroke by age and peripheral vascular disease, suggesting different pathways leading to stroke in these patients.

Funding Acknowledgement
Type of funding sources: Foundation. Main funding source(s): Hartstichting
Cardiac arrhythmias and conduction disorders monitoring after transcatheter aortic valve replacement procedure, using a mobile electrocardiogram 6 lead device
Authors: De Lucia R , Giannini C , Parollo M , Costa G , Barletta V , Giannotti Santoro M , Primerano C , De Carlo M , Angelillis M , Zucchelli G , Petronio A S 
Published: October 2022

Abstract

Background
In the early post transcatheter aortic valve replacement (TAVR) discharge era, rate of readmission for permanent pacemaker implantation (PPM-I) due to delayed conduction disturbances (CDs) has significantly increased. This issue has powered post procedural ambulatory electrocardiogram (AECG) monitoring by using implantable cardiac monitors or mobile cardiac telemetry devices, despite several disadvantages as frequent electrode changes and costs.

Purpose
In this scenario we aimed to evaluate the incidence of post-TAVR new onset arrhythmias and delayed CDs, performing an AECG monitoring through a 30s spot digital ECG (AeECG), by using a mobile electrocardiogram 6 lead (ME6L) device in a 30 days period after a TAVR procedure.

Methods
Between March 2021 and February 2022 we consecutively enrolled all patients undergoing a TAVR at the University Hospital of Pisa, excepting who already had a PM. At discharge, all patients received ME6L device and were asked to record a spot eECG for 1 month: 1 eECG per day during the first week and then 1 eECG per week. Clinical and follow-up data were collected and analyzed, and eECG scheduling compliance and quality recordings were explored.

Results
Among 185 consecutive TAVR patients, 12 were excluded due to pre-existing pacing device and 33 due to PPM-I &lt;2 days post TAVR; 3 died before enrollment and 10 refused the enrollment; 18 were excluded because failed the ME6L training phase, 6 for severe postprocedural complications and the last 3 because affected by isolated aortic regurgitation.The remaining ones (100) had 30-day AeECG data. Delayed CDs with a Class I/IIa indications for PPM-Ioccurred in 8 patients with a median of 6 days (range 4–8 days) post-TAVR. New onset documented arrhythmias were AT/AF in 3 patients, isolated PVCs in 10 patients, and competitive transitory junctional rhythm in 2 patients. Delayed PPM-I versus non-delayed PPM-Ipatients were more likely to have a non-self-expandable valve (3 vs 69; p=0.02) and longer PR and QRS intervals at discharge (250.00±53,29 ms vs 179.17±39.17 ms; p=0,003; 125±33.38 ms vs 102.55±30.48 ms; p=0,04). The overall eECG schedule level compliance was 96.5%. Out of a total of 965 sent eECGs, 950 (98,4%) have been correctly recorded and transmitted.

Conclusion
Delayed CDs requiring PPM-I are the most important drawback of TAVR procedure. In our study, AeECG was seen to be safe and helpful in the identification and treatment of delayed CDs requiring PPM-I, with a very high eECG schedule level of compliance and quality. Further prospective studies are needed to better identify patient selection for outpatient monitoring, making safer and safer the early post TAVR discharge approach.

Funding Acknowledgement
Type of funding sources: None.
Impact of periprocedural pulmonary hypertension on outcomes after TAVR: novel risk stratification from the OCEAN-TAVI Registry
Authors: Miyamoto J , Ohno Y , Ikari Y , Tada N , Naganuma T , Yamawaki M , Yamanaka F , Shirai S , Mizutani K , Tabata M , Ueno H , Takagi K , Watanabe Y , Yamamoto M , Hayashida K 
Published: October 2022

Abstract

Aim
There are limited data on prognostic impact of periprocedural pulmonary hypertension (PH) after transcatheter aortic valve replacement (TAVR). The aim of this study was to investigate the prognostic impact of normalized, new-onset, and residual PH after TAVR.

Methods and results
OCEAN-TAVI registry is an ongoing, multicenter Japanese registry which includes 2588 patients who underwent TAVR. Patients were classified into 4 groups according to periprocedural systolic pulmonary artery pressure (sPAP) by echocardiography: pre-no PH/post-no PH (no PH) group, pre-PH/post-no PH (normalized PH) group, pre-no PH/post-PH (new-onset PH) group, and pre-PH/post-PH (residual PH) group. PH was defined as sPAP&gt;36mmHg. Primary endpoint was all-cause mortality at 2 years. Logistic regression analysis was used to identify the clinical predictors of residual and new-onset PH. In total, 1872 patients were divided into 4 groups: 1027 patients (54.9%) in the no PH, 257 patients (13.7%) in the normalized PH, 280 patients (15.0%) in the new-onset PH, and 308 patients (16.5%) in the residual PH group, respectively. There was a significant difference in all-cause mortality among the 4 groups at 2 years (11.0%, 12.8%, 18.6%, and 24.7%, respectively; P&lt;0.01). Among 565 patients who had pre-procedural PH, 257 patients (45.5%) experienced normalization of PH with mortality comparable with no PH group. In multivariable logistic regression analysis, predictors of residual PH after TAVR were atrial fibrillation and baseline tricuspid regurgitation&gt;moderate, whereas prosthesis-patient mismatch (PPM) was a predictor of new-onset PH.

Conclusions
Risk stratification based on improvement in PH or new-onset/residual PH after TAVR can identify patients at increased mortality after TAVR. PPM was identified as a novel predictor of new-onset PH.

Funding Acknowledgement
Type of funding sources: Private company. Main funding source(s): The OCEAN-TAVI registry is supported by Edwards Lifesciences, Medtronic Japan, Boston Scientific, Abbott Medical, and Daiichi-Sankyo company.
Combined strategy for large-bore arteriotomy closure after transcatheter aortic valve implantation
Authors: Sluka M , Ostransky J , Nykl R 
Published: October 2022

Abstract

Background
The access site vascular complications remain a relevant complication following transcatheter aortic valve implantation (TAVI). They are frequently associated with vascular closure device failure (VCD). Incidence of vascular complications depends on different factors such as patient's characteristics and clinical risk profile, femoral morphology, access sheath size or technical procedural experience. Their rate is reported between 4–19% [1]. Vascular complications negatively affect morbidity and mortality following TAVI [2]. VCDs that are most commonly used include the suture-based ProGlide and the plug-based MANTA. ProGlide was originally developed for small-bore vessel closure between 6–8F, but a combination of 2 or more devices is suitable for large-bore vessel closure &gt;12F. The MANTA device is originally dedicated for large-bore vessel closure. The MANTA device was not superior to the use of 2 ProGlides in their direct comparison in terms of access site–related vascular complications or access site bleedings. Plug-based VCDs required fewer, but a different kind of bailout maneuvers [3,4]. The alternative and less frequently used strategy is intentional combination of one suture-based VCD – ProGlide with small-bore plug-based VCD AngioSeal. The data supporting this approach are very limited, but showing this concept as a safe, with lower risk of vascular or bleeding complications. Moreover, this strategy requires less additional endovascular interventions when compared with vascular closure using two suture-based VCDs [5].

Methods
Retrospectively analysed single centre comparison of two different large-bore vessel closure strategies: two suture-based ProGlides (SB group) vs. intentional combination of one ProGlide with plug-based AngioSeal 8F (CB group). The primary endpoint was occurrence of access site–related vascular complications at 30-days.

Results
71 consecutive patients treated between Aug/2020 and May/2021 (SB group) were compared with 68 consecutive patients treated between May/2021 and Jan/2022 (CB group). There wasn`t any significant difference in patient's characteristics between both groups: mean age 80 vs. 81 years, females 53,8% vs. 54,9%, STS score 3,46% vs. 3,47%. The only difference was higher proportion of the patients treated oral anticoagulation in SB group (46,4% vs. 38,5%). The lower rate of vascular complication was observed in CB group 2,9% vs. 7,1%. Moreover, we had to use additional VCD in 14 cases among patients from SB group to achieve haemostasis.

Conclusion
The intentional combination of one suture-based VCD with one plug-based VCD is effective and safe. This combined strategy was associated with lower rate of vascular complication compare the use of 2 suture-based VCDs in our patient's cohort following TAVI.

Funding Acknowledgement
Type of funding sources: None.
Predictors of mitral valve hemodynamics after mitral valve repair for degenerative mitral regurgitation: a subanalysis of the CAMRA randomized trial
Authors: Rumman R , Verma S , Chan V , Mazer D , Quan A , De Varennes B E , Chu M W A , Latter D , Teoh H , Yanagawa B , Leong-Poi H , Connelly K 
Published: October 2022

Abstract

Introduction
Intra-operative predictors of mid-to-late mitral valve dysfunction after surgical repair of mitral regurgitation (MR) caused by prolapse remain poorly characterized. This study aims to evaluate the effect of annuloplasty prosthesis size on post-operative MV hemodynamics at rest and during exercise, and to identify perioperative predictors of MV dysfunction.

Methods
104 patients were randomly assigned to resection and preservation for surgical treatment of posterior leaflet prolapse in the Canadian Mitral Research Alliance CardioLink-2 study. Echocardiograms were performed at baseline and 1 year postoperatively. Intraoperative TEE was performed to assess immediate MV gradients. Exercise TTE was performed 1 year after repair. Linear regression analysis was used to identify associations between MV indices (rest and peak exercise gradients) at 12 months, and perioperative echocardiographic and clinical factors.

Results
Mean age of participants was 65±10 years, and 83% were male. Larger annuloplasty size was associated with lower transmitral gradients at rest and during peak exercise. In multivariable analysis, annuloplasty size ≥34mm was associated with lower mean and peak rest and exercise gradients at 12 months, after adjustment for repair type, age, sex, and BSA (p&lt;0.001). Higher pre-operative pulmonary artery pressures were associated with reduced functional capacity post-operatively. Intra-operative TEE gradients predict resting and exercise MV hemodynamics at 1 year.

Conclusion
Annuloplasty size ≥34mm is associated with improved MV hemodynamics at rest and during peak exercise 1 year post MV repair. MV repair prior to onset of pulmonary hypertension confers favourable post operative functional capacity. Finally, intra-operative TEE can be used to identify patients at risk of mitral valve dysfunction within 1 year of repair.

Funding Acknowledgement
Type of funding sources: Other. Main funding source(s): The Heart and StrokeFoundation of Ontario (GIA 16-00014666)
Echocardiographic predictors of operative outcome for transapical off-pump mitral valve repair with neochord implantation
Authors: Perez Camargo D , Cobiella Carnicer J , Mahia Casado P , Carnero Alcazar M , Campelos Fernandez P , Montero Cruces L , Maroto Castellanos L C 
Published: October 2022

Abstract

Introduction
Transapical off-pump mitral valve repair with artificial neochord implantation (TOP-MINI) is safe and effective for the treatment of primary mitral regurgitation12, however, the current literature regarding echocardiographic criteria prior to the procedure is scarce.

Objective
To identify preoperative echocardiographic predictors of technical success after TOP-MINI for severe primary mitral regurgitation.

Methods
All consecutive patients who underwent TOP-MINI for severe primary mitral regurgitation from 2017 to 2022 were included. Preoperative echocardiographic evaluation included transthoracic and transesophageal echocardiography. Transesophageal evaluation included 2D measurements of mitral valve annulus, mitral leaflets, flail gap, and 3D mitral valve reconstruction among others, the leaflet-to-annulus index was estimated in all patients. Mitral valve morphology was classified as: Type A (Central posterior leaflet prolapse/flail) or non-Type A (Type B: posterior multisegment involvement; type C: anterior leaflet prolapse; type D: paracommissural or calcified leaflet). Technical success was defined according to the Mitral Valve Academic Research Consortium criteria. Independent echocardiographic predictors for the primary outcome were identified using a multivariate logistic regression model.

Results
Fifty-five patients were included. Mean age was 66.7 years (SD 12.9). Technical success with MR &lt;2+ was achieved in 48 (87.27%) patients. Significant predictors for technical success were the leaflet-to-annulus index (OR 1.09; p=0.012; 95% CI: 1.02–1.15), with an optimal cutoff value of 1.26 (sensitivity 73.3%, specificity 85.7%); and a non-type A valve morphology (OR 0.04; p=0.024; 95% CI: 0.01–0.65). The model showed good discrimination (AUC = 0.92) and calibration (Hosmer-Lemeshov p=0.21).

Conclusion
A thorough preoperative echocardiographic evaluation is key to improve outcomes in TOP-MINI. In this study, a leaflet-to-annulus index &gt;1.26 was associated with technical success, whether a non-type A valve morphology was associated with technical failure. These parameters could help to identify proper candidates for this technique.

Funding Acknowledgement
Type of funding sources: None.
18F-sodium fluoride positron emission tomography and coronary plaque radiomics derived from computed tomography angiography for prediction of myocardial infarction
Authors: Kwiecinski J , Kolossvary M , Tzolos E , Meah M N , Adamson P D , Joshi N V , Williams M C , Van Beek E J R , Berman D S , Maurovich-Horvat P , Newby D E , Dweck M R , Dey D , Slomka P 
Published: October 2022

Abstract

Background
Assessments of coronary disease activity with 18F-sodium fluoride positron emission tomography (18F-NaF PET) and radiomics-based precision coronary plaque phenotyping derived from contrast-enhanced computed tomography (CT) have both been shown to enhance risk stratification in patients with coronary artery disease (CAD). To date, no study has investigated whether these two promising methods (which can be obtained during a single imaging session on a hybrid PET/CT scanner) are interchangeable or can provide superior predictive performance when used in combination.

Purpose
We sought to investigate whether the prognostic information provided by latent morphological radiomic coronary plaque features and assessments of disease activity by 18F-NaF PET are complementary in prediction of myocardial infarction.

Methods
Patients with known CAD underwent coronary 18F-NaF PET and CT angiography on a hybrid PET/CT scanner. Coronary 18F-NaF uptake was determined by the coronary microcalcification activity (CMA). We performed quantitative plaque analysis of coronary CT angiography datasets. Additionally, coronary plaque segmentations on CT angiography were used to extract 1103 radiomic features. Using weighted correlation network analysis we derived latent morphological features of coronary plaques which were aggregated to patient-level radiomic normograms to predict myocardial infarction using univariate and multivariate Cox proportional hazard models.

Results
The study cohort comprised of 260 patients with established CAD (age: 65±9 years; 84% men); 179 (69%) participants showed increased coronary 18F-NaF activity (CMA &gt;0). Over 53 [40–59] months of follow-up 18 patients had a myocardial infarction. Using weighted correlation network analysis, from the 1103 radiomic features we derived 15 distinct eigen radiomic features representing latent morphological coronary plaque patterns. On univariate cox modelling 7 of these emerged as predictors of myocardial infarction (Figure). Following adjustments for calcified, noncalcified and low-density noncalcified plaque volumes and 18F-NaF CMA 4 radiomic features (related to texture and geometry) remained independent predictors of myocardial infarction (Figure).

Conclusion(s)
In patients with established CAD latent morphological features of coronary plaques are predictors of myocardial infarction above and beyond plaque volumes and 18F-NaF uptake. Comprehensive plaque analysis with radiomics may enhance risk stratification of CAD patients.

Funding Acknowledgement
Type of funding sources: Public grant(s) – National budget only. Main funding source(s): NIH, Wellcome Trust
4 year outcomes in a prospective evaluation of transcatheter mitral valve-in-valve, valve-in-ring and valve-in-mitral annular calcification: results from the MITRAL trial
Authors: Guerrero M , Eleid M F , Wang D D , Pursnani A , Kodali S , George I , Palacios I , Makkar R , Satler L , Kaptzan T , Lewis B , Thaden J , Oh J , O'Neill W , Rihal C 
Published: October 2022

Abstract

Background
The MITRAL Trial (Mitral Implantation of TRAnscatheter vaLves) evaluates the safety and feasibility of balloon-expandable aortic transcatheter heart valves in patients with severe mitral valve disease with mitral annular calcification (MAC), failed surgical rings or failed bioprostheses.

Purpose
We sought to evaluate 4-year outcomes of patients enrolled in the MITRAL trial.

Methods
This is a prospective study that enrolled 91 high surgical risk patients at 13 sites in the U.S. 30 patients underwent Mitral Valve-in-Valve (MViV), 30 Valve-in-Ring (MViR) and 31 Valve-in-MAC (ViMAC). 4-year outcomes of these patients were evaluated in this analysis. Primary endpoints and key serious adverse events including deaths were adjudicated by an independent Clinical Events Committee. Cardiac computed tomography (CT) and echocardiographic images were evaluated by independent CT and Echocardiographic Core Laboratories.

Results
Mean age was 74.3±8.9 years. Most patients undergoing MViV and ViMAC were female (MVIV=63.3%, MViR=36.7% and ViMAC=71%). Mean STS score was 9.2±6.6% (MViV 10.2±6.5%, MViR 8.7±4.7%, ViMAC=8.6±8.2%). All-cause mortality at 4 years was higher for ViMAC and MViR: MViV=6.9% (cardiovascular 3.4%), MViR=48.1% (cardiovascular 18.5%), ViMAC=51.9% (cardiovascular 29.6%), p=0.002 (Figure 1). At 4 years, all survivors had ≤1+ mitral regurgitation and most had none or trace mitral regurgitation (MViV=87.5, MViR=33.3% and ViMAC=100%). Mean mitral valve gradients remained stable (MViV=5.9±2.2 mmHg, MViR= 6.6±5.1 mmHg, ViMAC=5.1±1.0 mmHg), Figure 2. Most survivors experienced significant improvement of symptoms and were in NYHA class I-II at 4-year follow-up (MViV=78.9%, MViR=66.7% and ViMAC=66.7%).

Conclusions
MViV is associated with excellent outcomes at 4 years. MViR and ViMAC were associated with higher mortality at 4 years. However, most survivors in all groups experienced sustained improvement of symptoms and stable THV performance at 4 years. Whether survival bias had an impact on THV performance and improved symptoms at follow-up is not known and deserves further evaluation.

Funding Acknowledgement
Type of funding sources: Private company. Main funding source(s): Unrestricted Research Grant from Edwards Lifesciences.