Association between triglyceride-glucose index and all-cause mortality in patients underwent transcatheter aortic valve replacement.

BACKGROUNDS: The prognosis of the triglyceride-glucose (TyG) index, a validated surrogate marker for insulin resistance, in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) remains unknown. METHODS: This study consecutively enrolled patients diagnosed with severe AS who underwent TAVR in a Chinese tertiary hospital from March 2013 to September 2023. Participants were stratified based on the TyG index cut-off value. Cox proportional hazards regression models were utilized to explore the association between the TyG index and all-cause mortality, including an assessment of interactions between the TyG index and various covariates on mortality outcomes. RESULTS: Among 1045 patients (mean age 74.7 years, 58.2% male), there was 134 all-cause mortality, resulting in a crude mortality rate of 64.3 per 1000 person-years. Adjusting for age, sex, body mass index, smoking, hypertension, diabetes mellitus, bicuspid aortic valve, atrial fibrillation, Society of Thoracic Surgeons (STS) score, and left ventricular ejection fraction, a per-unit increase in the TyG index was associated with a 41% higher all-cause mortality risk (HR 1.41, 95% CI 1.03-1.93, p = 0.030). Notably, the relationship between the TyG index and all-cause mortality was significantly modified by age (pinteraction = 0.027), sex (pinteraction = 0.007), hypertension (pinteraction = 0.030), and STS score (pinteraction = 0.002). CONCLUSIONS: A higher TyG index is significantly associated with an increased risk of all-cause mortality in AS patients after TAVR. These results underscore the importance of considering the TyG index in the prognostic evaluation of AS patients following TAVR.

Midterm Clinical Outcomes after Isolated Surgical and Transcatheter Aortic Valve Replacement in Low-Risk Patients with Aortic Stenosis.

PURPOSE: This study aimed to compare the clinical outcomes of isolated surgical aortic valve replacement (SAVR) and transfemoral (TF)-transcatheter aortic valve replacement (TAVR) in low-risk aortic stenosis (AS) patients. METHODS: A total of 696 low-risk (Society of Thoracic Surgeons score <4%) AS patients underwent isolated SAVR or TF-TAVR at five centers. After 1:1 propensity score matching, 159 pairs were identified. Early and follow-up events, including cardiac mortality and major adverse cardiac and cerebrovascular events (MACCE: all-cause mortality, heart failure admission, reoperation, prosthetic valve endocarditis, and stroke), were compared. RESULTS: Baseline characteristics are similar between the matched groups. There were no 30-day cardiac mortalities in either group. All-cause mortality and MACCE at 30 days did not differ. During 5-year follow-up (median 3.1 [range 0-7.2] years), the incidence of cardiac mortality (1.3% vs. 18.9%; adjusted hazard ratio [aHR], 8.89; 95% confidence interval [CI], 2.68-29.53; P <0.001), all-cause mortality (4.2% vs. 33.9%; aHR, 8.56; 95% CI, 3.41-21.45; P <0.001), and MACCE (25.1% vs. 47.0%; aHR, 2.36; 95% CI, 1.54-3.63; P <0.001) were lower in the SAVR group than in the TAVR group. CONCLUSIONS: Isolated SAVR demonstrated better outcomes in low-risk AS patients. TAVR in this subset should be chosen carefully.

Periprocedural Assessment of Paravalvular Regurgitation After Transcatheter Aortic Valve Replacement Using Diastolic Delta and Videodensitometry.

BACKGROUND: Paravalvular regurgitation (PVR) is a common complication after transcatheter aortic valve replacement, posing an increased risk of heart failure and mortality. Accurate intraprocedural quantification of PVR is challenging. Both hemodynamic indices and videodensitometry can be used for intraprocedural assessment of PVR. We compared the predictive value of the isolated versus combined use of the hemodynamic index diastolic delta (DD) and videodensitometry for the incidence of relevant PVR 1 month after transcatheter aortic valve replacement. METHODS AND RESULTS: In this prospective cohort study, patients underwent periprocedural PVR assessment by DD and videodensitometry (using left ventricular outflow tract-aortic regurgitation [LVOT-AR]). Cardiac magnetic resonance served as reference modality for PVR assessment. Relevant PVR was defined as cardiac magnetic resonance-regurgitant fraction >20%. Fifty-one patients were enrolled in this study. Mean age was 80.6±5.2 years and 45.1% of patients were men. Mean LVOT-AR and cardiac magnetic resonance-regurgitant fraction were 8.2%±7.8% and 11.7%±9.6%, respectively. The correlation between DD and LVOT-AR was weak (r=-0.36). DD and LVOT-AR showed a comparable accuracy to predict relevant PVR (area under the curve 0.82, 95% CI: 0.69-0.95 versus area area under the time-density curve 0.80, 95% CI: 0.62-0.99). The combination of DD and LVOT-AR improved the prediction of relevant PVR (area under the time-density curve, 0.90, 95% CI: 0.81-0.99), and resulted in an increased concordance (86.3%) and positive predictive value (75%) compared with DD alone (76.5% and 40%, respectively), or LVOT-AR alone (82.3% and 50%, respectively). CONCLUSIONS: DD and videodensitometry are both accurate and feasible modalities for the assessment of PVR after transcatheter aortic valve replacement. The synergistic use of both techniques increases the predictive value for relevant PVR after transcatheter aortic valve replacement. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04281771.

Recovery rate from conduction disorders in patients with permanent pacemaker implantation after transcatheter aortic valve implantation.

BACKGROUNDS: Permanent pacemaker implantation (PPMI) is one of the greatest disadvantages of transcatheter aortic valve implantation (TAVI). To seek the predictors and clinical impacts of PPMI and investigate the recovery rate from conduction disorders. METHODS: We retrospectively analysed data from 745 consecutive patients who underwent TAVI for severe aortic stenosis from November 2013 to July 2022. The ventricular pacing (VP) rate was recorded at 1 and 6 months after PPMI and the recovery from conduction disorders was defined as the VP rate <1%. RESULTS: Postoperative PPMI was performed in 7.1% (53/745) of patients. Balloon predilatation was significantly frequent in the PPMI (-) group (52.8% (28/53) vs 80.6% (558/692); p<0.001) and the oversizing ratio was significantly greater in the PPMI (+) group (11.8%±10.1% vs 9.1%±9.7%; p=0.035). Freedom from rehospitalisation due to heart failure rate was significantly higher in the PPMI (-) group (p=0.032). In patients with postoperative PPMI, recovery from conduction disorders was observed in 17.0% and 27.9% of patients at 1 and 6 months, respectively. CONCLUSIONS: Recovery from conduction disorders occurred frequently. Avoidance of oversizing and extension of observation time may reduce the need for PPMI after TAVI.

Impact of Balloon-Expandable TAVR Valve Deformation and Calcium Distribution on Outcomes in Bicuspid Aortic Valve.

BACKGROUND: Research on the role of transcatheter heart valve (THV) deformation and calcium distribution in patients with bicuspid aortic valves (BAVs) undergoing transcatheter aortic valve replacement (TAVR) remains limited. OBJECTIVES: The aim of this study was to evaluate the impact of THV deformation on clinical outcomes in individuals with BAVs undergoing TAVR and the influence of calcium on these outcomes. METHODS: In total, 229 consecutive patients with BAVs who underwent TAVR with balloon-expandable valves and had computed tomography (CT) performed 30 days post-TAVR were analyzed. Patients were stratified into 3 groups: group 1 (n = 125), with no THV underexpansion or eccentricity; group 2 (n = 69), with underexpansion or eccentricity; and group 3 (n = 35), with both. Calcium distribution was assessed using CT, and its associations with clinical outcomes, including all-cause mortality at 3 years and leaflet thrombosis at 30 days, were determined. A subgroup analysis of patients with type 1 BAVs was conducted. RESULTS: Group 3 exhibited higher rates of all-cause mortality than the other groups, along with the highest risk for hypoattenuated leaflet thickening at 30 days. Multivariate analysis identified annular and left ventricular outflow tract calcification as independent predictors of all-cause mortality and hypoattenuated leaflet thickening. In patients with type 1 BAVs, excessive calcification at the raphe and opposite leaflet were associated with all-cause mortality at 3 years. CONCLUSIONS: THV deformation post-TAVR was significantly linked to all-cause mortality in patients with BAVs. Annular and left ventricular outflow tract calcification correlated with increased risks for all-cause mortality and leaflet thrombosis. (Assessment of Transcatheter and Surgical Aortic Bioprosthetic Valve Thrombosis and Its Treatment With Anticoagulation [RESOLVE]; NCT02318342).

Management of Fluid Overload in Patients With Severe Aortic Stenosis (EASE-TAVR): A Randomized Controlled Trial.

BACKGROUND: Fluid overload (FO) subjects patients with severe aortic stenosis (AS) to increased risk for heart failure and death after valve replacement and can be objectively quantified using bioimpedance spectroscopy (BIS). OBJECTIVES: The authors hypothesized that in AS patients with concomitant FO, BIS-guided decongestion could improve prognosis and quality of life following transcatheter aortic valve replacement (TAVR). METHODS: This randomized, controlled trial enrolled 232 patients with severe AS scheduled for TAVR. FO was defined using a portable whole-body BIS device according to previously established cutoffs (≥1.0 L and/or ≥7%). Patients with FO (n = 111) were randomly assigned 1:1 to receive BIS-guided decongestion (n = 55) or decongestion by clinical judgment alone (n = 56) following TAVR. Patients without FO (n = 121) served as a control cohort. The primary endpoint was the composite of hospitalization for heart failure and/or all-cause death at 12 months. The secondary endpoint was the change from baseline to 12 months in the Kansas City Cardiomyopathy Questionnaire. RESULTS: The occurrence of the primary endpoint at 12 months was significantly lower in the BIS-guided vs the non-BIS-guided decongestion group (7/55 [12.7%, all deaths] vs 18/56 [32.1%, 9 hospitalizations for heart failure and 9 deaths]; HR: 0.36; 95% CI: 0.15-0.87; absolute risk reduction = -19.4%). Outcomes in the BIS-guided decongestion group were identical to the euvolemic control group (log-rank test, P = 0.7). BIS-guided decongestion was also associated with a higher increase in the Kansas City Cardiomyopathy Questionnaire score from baseline compared to non-BIS-guided decongestion (P = 0.001). CONCLUSIONS: In patients with severe AS and concomitant FO, quantitatively guided decongestive treatment and associated intensified management post-TAVR was associated with improved outcomes and quality of life compared to decongestion by clinical judgment alone. (Management of Fluid Overload in Patients Scheduled for Transcatheter Aortic Valve Replacement [EASE-TAVR]; NCT04556123).

Asymmetrical Expansion of Balloon-Expandable Transcatheter Aortic Valve Prostheses: Implications for Valve Hemodynamic and Clinical Outcomes.

BACKGROUND: Asymmetrical expansion of transcatheter heart valves (THVs), manifesting as stent frame deformation, is an occasional fluoroscopic finding in transcatheter aortic valve replacement (TAVR). OBJECTIVES: The aim of this study was to investigate the impact of asymmetrical expansion of balloon-expandable THVs on hemodynamic valve performance and clinical outcomes. METHODS: In a prospective registry, TAVR asymmetry index was measured using freeze-frame fluoroscopic images and was defined as the ratio of THV heights: [(longer height/shorter height) - 1] × 100. THV hemodynamic performance was measured using echocardiography before hospital discharge. Impaired hemodynamic valve performance was defined as a mean residual THV gradient ≥20 mm Hg and/or moderate or greater paravalvular regurgitation. RESULTS: Among 1,216 patients undergoing transfemoral TAVR for native severe aortic valve stenosis with contemporary balloon-expandable THVs between February 2014 and June 2022, asymmetry index was an excellent predictor of impaired hemodynamic valve performance (area under the receiver-operating characteristic curve: 0.88; 95% CI: 0.84-0.92; P < 0.001). The optimal asymmetry index threshold for predicting impaired THV performance was >5.5% (sensitivity 77%, specificity 86%) and occurred in 17% of patients. Higher asymmetry index, as a continuous variable, was associated with impaired hemodynamic valve performance independent of total aortic valve calcium, bicuspid anatomy, balloon-expandable valve prosthesis type or size, and Society of Thoracic Surgeons Predicted Risk of Mortality score (OR: 1.37; 95% CI: 1.29-1.46; P < 0.001). High TAVR asymmetry index was not associated with all-cause mortality during a median of 376 days of follow-up (HR: 1.00; 95% CI: 0.71-1.41; P = 0.989). CONCLUSIONS: Asymmetrical expansion of balloon-expandable THVs was associated with impaired hemodynamic valve performance but not with clinical outcomes.

Outcomes of transcatheter aortic valve implantation for native aortic valve regurgitation.

BACKGROUND: Large datasets of transcatheter aortic valve implantation (TAVI) for pure aortic valve regurgitation (PAVR) are scarce. AIMS: We aimed to report procedural safety and long-term clinical events (CE) in a contemporary cohort of PAVR patients treated with new-generation devices (NGD). METHODS: Patients with grade III/IV PAVR enrolled in the FRANCE-TAVI Registry were selected. The primary safety endpoint was technical success (TS) according to Valve Academic Research Consortium 3 criteria. The co-primary endpoint was defined as a composite of mortality, heart failure hospitalisation and valve reintervention at last follow-up. RESULTS: From 2015 to 2021, 227 individuals (64.3% males, median age 81.0 [interquartile range {IQR} 73.5-85.0] years, with EuroSCORE II 6.0% [IQR 4.0-10.9]) from 41 centres underwent TAVI with NGD, using either self-expanding (55.1%) or balloon-expandable valves (44.9%; p=0.50). TS was 85.5%, with a non-significant trend towards increased TS in high-volume activity centres. A second valve implantation (SVI) was needed in 8.8% of patients, independent of valve type (p=0.82). Device size was ≥29 mm in 73.0% of patients, post-procedure grade ≥III residual aortic regurgitation was rare (1.2%), and the permanent pacemaker implantation (PPI) rate was 36.0%. At 30 days, the incidences of mortality and reintervention were 8.4% and 3.5%, respectively. The co-primary endpoint reached 41.6% (IQR 34.4-49.6) at 1 year, increased up to 61.8% (IQR 52.4-71.2) at 4 years, and was independently predicted by TS, with a hazard ratio of 0.45 (95% confidence interval: 0.27-0.76); p=0.003. CONCLUSIONS: TAVI with NGD in PAVR patients is efficient and reasonably safe. Preventing the need for an SVI embodies the major technical challenge. Larger implanted valves may have limited this complication, outweighing the increased risk of PPI. Despite successful TAVI, PAVR patients experience frequent CE at long-term follow-up.

Aortic regurgitation: from mechanisms to management.

Aortic regurgitation (AR) is a common clinical disease associated with significant morbidity and mortality. Investigations based largely on non-invasive imaging are pivotal in discerning the severity of disease and its impact on the heart. Advances in technology have contributed to improved risk stratification and to our understanding of the pathophysiology of AR. Surgical aortic valve replacement is the predominant treatment. However, its use is limited to patients with an acceptable surgical risk profile. Transcatheter aortic valve implantation is an alternative treatment. However, this therapy remains in its infancy, and further data and experience are required. This review article on AR describes its prevalence, mechanisms, diagnosis and treatment.

Acurate neo2 is associated with a reduced inflammatory response in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.

BACKGROUND: Inflammation following transcatheter aortic valve implantation (TAVI) is associated with an increased risk of adverse outcomes. The aim of this study was to compare the inflammatory response between low radial force valves (Acurate neo2, Boston Scientific) and high radial force valves (Evolut R/Pro, Medtronic; SAPIEN Edwards Lifesciences; and Myval, Meril valves). METHODS: We conducted a retrospective study of patients with severe aortic stenosis treated with TAVI between 2021 and 2022. The primary endpoint was the difference in the inflammatory response between low radial force valves and high radial force valves, measured as the difference between post-procedural and pre-procedural high-sensitivity C-reactive protein levels (hsCRP delta). RESULTS: A total of 114 patients were included, of which 65 patients (57%) received a low radial force valve. The hsCRP delta was lower in the low radial force valve group compared to the high radial force valve group (8.7 [2.1-15.6] mg/L vs. 18.8 mg/dL [6.4-19] mg/L; P=0.003), due to a lower post-implantation hsCRP (8.9 [5.45-19.6] mg/L vs. 15.8 [9.8-27.3] mg/L; P=0.013). The incidence of new left bundle branch block (LBBB) after TAVI was lower in the low radial force valve group compared to the high radial force valve group (11 [17%] vs. 18 [37%]; P=0.020). CONCLUSIONS: Low radial force TAVI prostheses were associated with a lower inflammatory response, and a lower incidence of new LBBB compared to the radial force valve group, suggesting that inflammation may contribute to the increased risk of conduction disturbances.

Clinical implications of Sokolow-Lyon voltage less than 3.5 mV in patients who have undergone transcatheter aortic valve replacement.

BACKGROUND: Degenerative severe aortic valve stenosis (AS) is increasingly prevalent in the aging population, leading to the adoption of transcatheter aortic valve replacement (TAVR) as a less invasive alternative. While TAVR indications have expanded, the procedure is associated with a substantial incidence of major adverse cardiac events (MACE). The study aims to establish a preoperative risk-stratification system for TAVR candidates based on Sokolow-Lyon voltage (SLV) and other relevant factors. METHODS: A total of 181 consecutive patients who underwent TAVR were retrospectively reviewed. Baseline characteristics, preoperative electrocardiogram (ECG) and echocardiography findings, and TAVR procedures were assessed. Low SLV (<3.5 mV) was defined based on ECG measurements. RESULTS: Baseline characteristics revealed a mean age of 84 years, with 71.8% females. The two-year incidence of MACE defined as a composite of cardiac death and hospitalization due to heart failure, was 11.6%, significantly higher in the low SLV group. Low SLV emerged as an independent prognostic factor. The Tokyo Bay Risk (TBR) Score, including low SLV, Body Mass Index <18.5 kg/m2, and previous coronary artery disease, effectively stratified MACE risk. Higher TBR scores (2 or 3) correlated with increased MACE risk. CONCLUSIONS: Patients with low SLV in pre-procedural ECG demonstrated a heightened risk of two-year MACE. The TBR score, incorporating low SLV, proved valuable for preoperative risk assessment. Careful consideration of TAVR indications, along with TBR score integration, is crucial for optimizing outcomes.

Rupture of the ascending aorta 6 months after TAVI procedure caused by TAVI prosthesis.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is indicated for elderly patients who often have severe comorbidities and high operative risk. Despite many advantages, it carries the potential for both early and late complications. The literature reports mainly periprocedural problems. This case report describes a rare instance of ascending aortic rupture as a late complication following TAVI. CASE PRESENTATION: An 81-year-old male with severe aortic stenosis (AS) was a non-surgical patient due to a high operative risk (EuroSCORE II 14.08%) and comorbidities, including cardiovascular problems, chronic obstructive pulmonary disease, myelodysplastic syndrome. During the TAVI procedure Medtronic CoreValve™ Evolut™ R-26 was implanted via the right femoral artery. Postoperative period elapsed without complications and the patient was discharged home. Six months later, the patient was re-admitted to the hospital on an emergency basis and transferred directly to the operating room due to ascending aortic rupture (EuroSCORE II 53.20%, GERAADA score 64.9%). Computed tomography angiography (CTA) showed aortic rupture with a multiple fresh blood reservoirs and thrombus around the ascending aorta originating from the spot where the nitinol frame of the TAVI valve was attached to the native aorta. Supracoronary excision of the ascending aorta with implantation of a vascular graft (Intergard Woven Graft 34 mm) was performed, preserving the earlier implanted TAVI valve. On the 9th day after surgery the patient's general condition deteriorated, he suffered from circulatory and respiratory insufficiency. Furthermore, a gastrointestinal bleeding with the need for gastro-, and colonoscopy and multiple blood transfusions occurred. Patient developed urosepsis and acute renal failure with the need for hemodiafiltration. Despite intensive treatment, further deterioration of the medical condition of the patient. and finally the multiple organ failure was observed. Patient died on the 50th postoperative day. CONCLUSIONS: TAVI is a safe method of treating severe AS, especially recommended for non-surgical candidates. Rupture of the ascending aorta is a rare but serious complication of TAVI that usually occur during or shortly after the procedure. This case report highlights the importance of post-procedural monitoring for such TAVI complications, even in the late period following TAVI, and if such complications occur, taking the risk to perform a life-saving operation.

3-Year Outcomes of Balloon-Expandable Valves: 20-mm vs Larger Valves (≥23 mm).

BACKGROUND: A prior Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry-based analysis reported similar 1-year clinical outcomes with small (20-mm) vs large (≥23-mm) balloon-expandable valves (BEV). OBJECTIVES: The aim of this study was to describe mid-term 3-year clinical outcomes for small vs large BEV and the relationship between discharge echocardiographic mean gradient (MG) and different definitions of prothesis-patient mismatch (PPM) with clinical outcomes. METHODS: Using the TVT Registry with Centers for Medicare and Medicaid Services linkage, a propensity-matched analysis of patients receiving 20- vs ≥23-mm BEVs was performed. Spline curves and Kaplan-Meier plots with adjusted HRs determined the relationship between MG and 3-year mortality. RESULTS: In total, 316,091 patients were analyzed; after propensity matching, 8,100 pairs of each group were compared. The 20-mm BEV was associated with higher MGs compared with ≥23-mm BEVs (16.2 ± 7.2 mm Hg vs 11.8 ± 5.7 mm Hg; P < 0.0001). At 3 years, there was no difference in mortality between 20- and ≥23-mm BEVs (31.5% vs 32.5%, respectively; HR: 0.97; 95% CI: 0.90-1.05). Compared with an MG of 10 to 30 mm Hg, an MG <10 mm Hg (HR: 1.25; 95% CI:1.22-1.27) was associated with increased 3-year mortality. Measured severe PPM and predicted no PPM were associated with increased 3-year mortality (33.5% vs 32.9% vs 32.1%; P < 0.0001) and (33.5% vs 31.1% vs 30%; P < 0.0001), respectively. Low MG and severe measured PPM were associated with lower left ventricular ejection fraction (LVEF). CONCLUSIONS: Patients with small-prosthesis BEVs (20 mm) had identical 3-year survival as those with larger (≥23-mm) BEV valves. Severe measured PPM and low MG (<10 mm Hg), but not predicted severe PPM, were associated with lower LVEF and increased mortality, suggesting that LVEF is the culprit for worse outcomes.