Valve Academic Research Consortium Research Articles

Determining risk factors for vascular and bleeding complications after TAVR using CT angiography

Abstract Funding Acknowledgements None. Introduction The use of pre-procedural computed tomography angiography (CTA) of the iliofemoral sector in the planning of transaortic valve replacement (TAVR) has demonstrated a reduction in the risk of vascular complications in patients undergoing TAVR. In this study, we aimed to characterise the clinical and radiological factors associated with bleeding and vascular complications after TAVR. Methods Patients undergoing transfemoral TAVR in a tertiary centre between 2017 and 2019 were included in this analysis. All patients underwent iliofemoral CTA before the procedure and classical CTA-derived data as well as iliofemoral calcium volume were collected. Clinical data and outcomes regarding bleeding events, as well as vascular complications according to Valve Academic Research Consortium 2 (VARC-2) criteria, were also collected. 207 patients were included in this analysis, of whom 53% were women. The median age was 82 years (IQR 76-86) and the median STS mortality risk score was 3.9% (IQR 2.59-5.99). In this population, vascular complications according to the VARC-2 criteria occurred in 33% of patients (19% with major complications). Patients with lower body mass index (BMI) were more likely to suffer vascular complications. Vascular access with fluoroscopy was associated with a higher prevalence of complications compared to ultrasound-guided vascular access (62% vs. 38%, p=0.037). When considering radiological criteria, smaller minimum luminal diameter and area of the common femoral and external iliac arteries were associated with a greater risk of vascular complications, as were increased sheath to external iliac artery ratios and luminal attenuation values (p<0.05 for all). Bleeding complications occurred in 20 patients, with a greater prevalence of bleeding events in female patients (77% vs. 23%, p=0.001). Patients with a lower BMI, a history of obstructive pulmonary disease or coronary artery disease, aortic insufficiency and fluoroscopic valvular access were more likely to have bleeding complications. Regarding radiological criteria, decreased maximal luminal diameter of the common femoral artery and smaller minimal luminal diameters and areas of the external iliac artery were associated with bleeding complications. Increased sheath-to-femoral artery ratios and luminal attenuation values were associated with an increased risk of vascular complications (p<0.05 for all). Conclusion Our study underscores the importance of pre-procedural CTA in TAVR planning and identifies separate risk factors for vascular and bleeding complications.

Simultaneous transapical transcatheter aortic and mitral valve replacement in patients with severe valve dysfunction: initial experience.

Simultaneous transcatheter mitral valve in valve (VIV) replacement and aortic valve replacement experience is limited. We report our initial experience with simultaneous transapical transcatheter aortic and mitral valve replacement in patients with severe valve dysfunction. A total of 8 patients had simultaneous transcatheter heart valve implants for severe mitral bioprosthesis failure (VIV), with a second valve procedure that included native aortic regurgitation (n = 3) or degenerated bioprostheses in the aortic position (n = 5). All patients were treated with a self-expandable J-valve transcatheter valve, using the transapical approach. The mean age of the patients was 73.1 ± 6.2years. The mean Society of Thoracic Surgeons score was 13.8 ± 6.3%. Device success was 100% according to Valve Academic Research Consortium-2 criteria. No other procedure-associated complications occurred, including left ventricular outflow tract obstruction and valve migration. The mean hospital lengths of stay after the procedure were 11.5 ± 8.0days. No deaths occurred at 30days. At a median follow-up period of 28.7 ± 22.3months, no patients died. All patients were in New York Heart Association functional classes I-II. Echocardiographic parameters at follow-up showed a normofunctioning J valve in the mitral position and a mean max mitral flow velocity of 2.0 ± 0.5m/s; the J valve in the aortic position was also normofunctioning, and the mean max aortic flow velocity was 2.3 ± 0.5m/s. Simultaneous transapical transcatheter aortic and mitral valve replacement using the self-expandable J valve appears to be a feasible and effective alternative to redo surgery.

Improved Hemodynamics With Self-Expanding Compared to Balloon-Expandable Transcatheter Aortic Valve Implantation in Small Annulus Patients: A Propensity-Matched Analysis

Patients with small aortic annuli (SAA) pose a challenge in patients undergoing aortic valve replacement because of the potential for prosthesis-patient mismatch (PPM). This study aimed to compare the clinical and hemodynamic outcomes of self-expandable valve (SEV) versus balloon-expandable valve (BEV) transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and SAA. All patients who underwent TAVI for severe native aortic stenosis with a SAA between January 2018 and December 2022 were retrospectively included in the study from a single center. Propensity score matching was performed to balance the baseline characteristics. Bioprosthesis valve dysfunction was based on modified Valve Academic Research Consortium 3 criteria. A total of 1,170 TAVI procedures were performed between 2018 and 2022. After applying the exclusion criteria, 332 patients reported a SAA at computed tomography scan, and the matching created 109 balanced pairs. Echocardiographic data at discharge showed higher mean transvalvular gradients (p <0.001), higher grades of mitral regurgitation (p = 0.029), and lower ejection fraction (p <0.043) in BEVs than SEVs. At follow-up, significant differences favoring the SEV group regarding bioprosthesis valve dysfunction were observed (p = 0.002), especially in terms of severe PPM (p = 0.046) and at least moderate structural valve deterioration (p = 0.040). In conclusion, TAVI in patients with SAA using a BEV was associated with lower valve areas, higher mean pressure gradients, and PPM (including severe) than a SEV. Short- and midterm all-cause and cardiac-related mortality did not differ between the 2 groups. Future randomized studies with extended follow-ups are warranted to validate these outcomes.

Safety and feasibility of early discharge after transcatheter aortic valve implantation with ACURATE Neo-the POLESTAR trial.

Transcatheter aortic valve implantation (TAVI) serves a growing range of patients with severe aortic stenosis (AS). TAVI has evolved to a streamlined procedure minimizing length of hospital stay. To evaluate the safety and efficacy of an early discharge (ED) strategy after TAVI. We performed an international, multi-center, prospective observational single-arm study in AS patients undergoing TAVI with the ACURATE valve platform. Eligibility for ED was assessed prior to TAVI and based on prespecified selection criteria. Discharge ≤ 48h was defined as ED. Primary Valve Academic Research Consortium (VARC)-3-defined 30-day safety and efficacy composite endpoints were landmarked at 48h and compared between ED and non-ED groups. A total of 252 patients were included. The median age was 82 [25th-75th percentile, 78-85] years and the median Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score was 2.2% [25th-75th percentile, 1.6-3.3]. ED and non-ED were achieved in 173 (69%) and 79 (31%) patients respectively. Monitoring for conduction disturbances was the principal reason for non-ED (33%). Overall, at 30days, all-cause mortality was 1%, new permanent pacemaker rate was 4%, and valve- or procedure-related rehospitalization was 4%. There was no difference in the primary safety and efficacy endpoint between the ED and non-ED cohorts (OR 0.84 [25th-75th percentile, 0.31-2.26], p = 0.73, and OR 0.97 [25th-75th percentile, 0.46-2.06], p = 0.94). The need for rehospitalization was similarly low for ED and non-ED groups. Early discharge after TAVI with the ACURATE valve is safe and feasible in selected patients. Rhythm monitoring and extended clinical observation protracted hospital stay.

Baseline NT-proBNP predicts acute kidney injury following transcatheter aortic valve implantation

Background/purposeAcute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) increases morbidity and mortality. Our study aimed to investigate the role of baseline N-terminal pro B-type natriuretic peptide (NT-proBNP) as a predictor of AKI following TAVI. MethodsAll consecutive TAVI patients were included in the analysis, except patients with dialysis and those with a GFR < 15 ml/min/1.73 m2 at baseline. Rates of AKI after TAVI were assessed according to the updated valve academic research consortium definitions using AKIN classification in three stages. NT-proBNP was measured at baseline. One-year mortality rates were assessed. ResultsWe included 1973 patients treated with TAVI between January 2006 and December 2016. Median [IQR] age was 81.0 [77.0;84.0] years, the STS score was 6.2 [3.9;9.0], and the logEuroScore was 14.5 [9.0;23.0]. 30-day and one-year mortality was 5.1 % and 16.1 % for all patients, respectively. Multivariate analysis revealed that patients with NT-proBNP levels higher than two times above the upper level of normal (ULN) had an increased risk for AKI after TAVI compared to patients with NT-proBNP levels < 2× ULN (OR 1.40 [1.03–1.91]). ConclusionsRoutine assessment of baseline NT-proBNP levels might be an additional tool to identify patients at increased risk for AKI after TAVI.

Transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation (ALIGN-AR): a prospective, multicentre, single-arm study

Surgery remains the only recommended intervention for patients with native aortic regurgitation. A transcatheter therapy to treat patients at high risk for mortality and complications with surgical aortic valve replacement represents an unmet need. Commercial transcatheter heart valves in pure aortic regurgitation are hampered by unacceptable rates of embolisation and paravalvular regurgitation. The Trilogy transcatheter heart valve (JenaValve Technology, Irvine, CA, USA) provides a treatment option for these patients. We report outcomes with transfemoral transcatheter aortic valve implantation (TAVI) in patients with pure aortic regurgitation using this dedicated transcatheter heart valve. The ALIGN-AR trial is a prospective, multicentre, single-arm study. We recruited symptomatic patients (aged ≥18 years) with moderate-to-severe or severe aortic regurgitation at high risk for mortality and complications after surgical aortic valve replacement at 20 US sites for treatment with the Trilogy transcatheter heart valve. The 30-day composite primary safety endpoint was compared for non-inferiority with a prespecified performance goal of 40·5%. The primary efficacy endpoint was 1-year all-cause mortality compared for non-inferiority with a performance goal of 25%. This trial is registered with ClinicalTrials.gov, NCT04415047, and is ongoing. Between June 8, 2018, and Aug 29, 2022, we screened 346 patients. We excluded 166 (48%) patients and enrolled 180 (52%) patients with symptomatic aortic regurgitation deemed high risk by the heart team and independent screening committee assessments. The mean age of the study population was 75·5 years (SD 10·8), and 85 (47%) were female, 95 (53%) were male, and 131 (73%) were White. Technical success was achieved in 171 (95%) patients. At 30 days, four (2%) deaths, two (1%) disabling strokes, and two (1%) non-disabling strokes occurred. Using standard Valve Academic Research Consortium-2 definitions, the primary safety endpoint was achieved, with events occurring in 48 (27% [97·5% CI 19·2-34·0]) patients (pnon-inferiority<0·0001), with new pacemaker implantation in 36 (24%) patients. The primary efficacy endpoint was achieved, with mortality in 14 (7·8% [3·3-12·3]) patients at 1 year (pnon-inferiority<0·0001). This study shows the safety and effectiveness of treating native aortic regurgitation using a dedicated transcatheter heart valve to treat patients with symptomatic moderate-to-severe or severe aortic regurgitation who are at high risk for mortality or complications after surgical aortic valve replacement. The observed short-term clinical and haemodynamic outcomes are promising as are signs of left ventricular remodelling, but long-term follow-up is necessary. JenaValve Technology.

ACURATE neo2 Versus SAPIEN 3 Ultra Transcatheter Heart Valve in Severe Aortic Valve Calcification: A Propensity-Matched Analysis.

Comparative data on transcatheter self-expanding ACURATE neo2 (NEO2) and balloon-expandable SAPIEN 3 Ultra prostheses in technically challenging anatomy of severe aortic valve calcified aortic annuli are scarce. A total of 1987 patients with severe native aortic stenosis treated with the self-expanding NEO2 (n=1457) or balloon-expandable SAPIEN 3 Ultra (n=530) from January 2017 to April 2023 were evaluated. The primary end point was procedural outcome according to the Valve Academic Research Consortium 3 definitions. Propensity matching defined 219 pairs with severe calcification (calcium density cutoff, 758 AU/cm2) of the native aortic valve. Technical success (90.4% versus 91.8%; risk difference, 1.4% [95% CI, -4.4 to -7.2]; P=0.737) and device success at 30 days (80.8% versus 75.8%; risk difference, -5.0% [95% CI, -13.2 to 3.1]; P=0.246) were comparable between NEO2 and SAPIEN 3 Ultra. The rate of severe prosthesis-patient mismatch (1.1% versus 10.1%; risk difference, 10.0% [95% CI, 4.0-13.9]; P<0.001) and mean transvalvular gradient ≥20 mm Hg (2.8% versus 14.3%; risk difference, 11.5% [95% CI, 5.8-17.1]; P<0.001) was lower with NEO2. The rate of more-than-mild paravalvular leakage or valve-in-valve due to paravalvular leakage was significantly higher (6.2% versus 0.0%; risk difference, 6.2% [95% CI, -10.1 to -2.7]; P=0.002), and there was a tendency for a higher rate of device embolization or migration (1.8% versus 0.0%; risk difference, -1.8% [95% CI, -4.1 to 0.4]; P=0.123) with NEO2. Multivarate regression revealed no independent impact of transcatheter heart valve selection on device success (odds ratio, 0.93 [95% CI, 0.48-1.77]; P=0.817). In patients with severely calcified annuli, supraannular implantation of NEO2 showed hemodynamic advantages. Nevertheless, NEO2 was associated with a higher incidence of relevant paravalvular leakage and a numerically higher rate of device embolization than SAPIEN 3 Ultra in this particular patient group.

The role of the vascular surgeon in transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) has become the standard treatment for severe aortic valve stenosis in patients at increased surgical risk. Percutaneous transfemoral (TF) is the access of choice due to its reduced invasiveness and perioperative morbidity/mortality compared with the trans-axillary, aortic, and apical routes. On the other hand, vascular access complications (VACs) of the TF access are associated with prolonged hospitalization, 30-day, and 1-year mortality. In addition, the concomitance of peripheral arterial disease may require associated endovascular management. A multidisciplinary team with Interventional Cardiologists and Vascular Surgeons may minimize the rate of VACs in patients with challenging femoral-iliac access or concomitant disease of other vascular districts, thus optimizing the outcome of TF-TAVI. The aim of this study was to evaluate the role of Vascular Surgeons in TF TAVI procedures. We conducted a retrospective single-center review of all TF-TAVI procedures assisted by Vascular Surgeons between January 2016 and December 2020 in a high-volume tertiary hospital. Pre, intra, and postoperative data were analyzed by a dedicated group of Interventional Cardiologists and Vascular Surgeons. VACs were defined according with the Valve Academic Research Consortium (VARC) three guidelines. The outcomes of TF-TAVI procedures with Vascular Surgeons involvement were assessed as study's endpoints. Overall, 937 TAVI procedures were performed with a TF approach ranging between 78% (2016) and 98% (2020). Vascular Surgeons were involved in 67 (7%) procedures with the following indications: concomitant abdominal aortic aneurysm (EVAR + TAVI) - 3 (4%), carotid stenosis (TAVI + CAS) - 2 (3%), hostile femoral/iliac access, or VACs - 62 (93%). Balloon angioplasty of iliac artery pre-TAVI implantation was performed in 51 cases (conventional PTA: 38/51%-75%; conventional PTA + intravascular lithotripsy: 13/51%-25%; stenting: 5/51%-10%). TAVI procedure was successfully completed by percutaneous TF approach in all 62 cases with challenging femoral/iliac access. VACs necessitating interventions were 18/937 (2%) cases, localized to the common femoral or common/external iliac artery in 15/18 (83%) and 3/18 (17%) cases, respectively. They were managed by surgical or endovascular maneuvers in 3/18 (17%) and 15/18 (83%) cases, respectively. Fifteen/18 (83%) VACs were treated during the index procedure. There was no procedure-related mortality or 30-day readmission. In our experience, Vascular Surgeon assistance in TAVI procedures was not infrequent and allowed safe and effective device introduction through challenging TF access. Similarly, the concomitant significant disease of other vascular districts could be safely addressed, potentially reducing postoperative related mortality and morbidity. The implementation of multidisciplinary team with interventional cardiologists and vascular surgeons should be encouraged whenever possible.

Analysis of complications in transfemoral transcatheter aortic valve implantation: a single-center study.

Transfemoral access is a prevailing approach for transcatheter aortic valve implantation (TAVI) in contemporary practice, with a shift from surgical arteriotomy to a percutaneous arterial approach. This study assessed long- and short‑term mortality, along with Valve Academic Research Consortium-2-defined complications in percutaneous transfemoral approach (PTA) TAVI. Furthermore, it explored the impact of a learning curve on procedural outcomes. The study included 600 patients undergoing PTA TAVI at the National Institute of Cardiology, Warsaw, Poland, from January 2009 to September 2020. Retrospective data comparison involved 2 groups: early experience (first 200 patients) and late experience (next 400 patients). The primary end point (composite of life‑threatening bleeding, major vascular complication, or death at 30 days) occurred less often in the late experience group (28% vs 17.5%; P = 0.003). The late experience group also showed fewer cases of vascular complications (19% vs 10.7%; P = 0.005) and major bleeding (17.5% vs 8.5%; P = 0.001). Propensity matching yielded similar trends, including reduced frequency of pacemaker implantation (22.8% vs 10.9%; P = 0.03) and shorter median (interquartile range) hospitalization (11 [8-18] vs 7 [6-12] days; P <0.001) in the late experience group. The late experience group rated with PTA TAVI exhibited significantly reduced periprocedural complications, indicating a positive impact of accumulated expertise.

Ultrasound-guided deployment of ProGlide™ device in transfemoral transcatheter aortic valve implantation and risk reduction of vascular complications: A propensity-matched cohort study.

ProGlide is a percutaneous suture-mediated closure device used in arterial and venous closure following percutaneous intervention. Risk of vascular complications from use, particularly related to failure in hemostasis, or acute vessel closure, remains significant and often related to improper suture deployment. We describe a technique of ultrasound-guided ProGlide deployment in transfemoral transcatheter aortic valve implantation (TF-TAVI). The aim of this study is to assess vascular outcomes for ultrasound-guided deployment of ProGlide vascular closure devices in patients undergoing TF-TAVI. We collected relevant clinical data of patients undergoing TAVI in a large volume centre. main access Valve Academic Research Consortium 3 (VARC-3) major vascular complication. any major/minor VARC-3 vascular complication, its type (bleed or ischemia), and treatment required (medical, percutaneous, or surgical). We performed inverse weighting propensity score analysis to compare the population undergoing ultrasound-guided versus conventional ProGlide deployment for main TAVI access. Ultrasound technique for ProGlide insertion was performed as described below. Five hundred and seventeen patients undergoing TF-TAVI were included. In 126 (ultrasound-guided) and 391 (conventional ProGlide insertion), 0% versus 1.8% (p < 0.001) had a major VARC-3 vascular complication, respectively. 0.8% (one minor VARC-3 bleed) vs 4.1% (13 bleeds and three occlusions) had any VARC-3 vascular complication (major and minor) (p < 0.001). Surgical treatment of vascular complication was required in 0.8% versus 1.3% (p = NS). Ultrasound-guided deployment of ProGlide for vascular closure reduced the risk of major vascular complications in a large population undergoing TAVI.

See It Best: A Propensity-Matched Analysis of Ultrasound-Guided versus Blind Femoral Artery Puncture in Balloon-Expandable TAVI.

Background: Currently, transcatheter aortic valve implantation (TAVI) is the standard procedure recommended for patients over 75 years of age with symptomatic aortic valve stenosis. Percutaneous transfemoral (TF) access is the main route used to perform the procedure. Among periprocedural complications, access-related ones are the most frequent, potentially leading to prolonged in-hospital stays and transfusions. Methods: We performed a retrospective analysis of prospectively collected data on consecutive patients undergoing TF-TAVI with the latest generation balloon-expandable transcatheter valve between 2013 and 2022. Results: A total of 600 patients were analyzed, differentiating the population between ultrasound-guided and blind common femoral artery puncture. Valve Academic Research Consortium 3 (VARC-3)criteria were used to report at 30 days and follow-up. In our propensity-matched comparison of the two groups, we found a strong reduction in access-related complications in the echo-guided group, particularly in terms of reduction of major and minor bleedings. We also found a significant trend in reduction of local complications, such as pseudoaneurysms, hematomas, arterio-venous fistulas, dissection of the femoral or iliac arteries, and stenosis. Conclusions: Although there is a lack of consensus on the role of ultrasound-guided puncture, we found better outcomes for patients having an echo-guided puncture of the main access, particularly with regard to access-related complications, early mobilization, and early discharge home.

Tricuspid Regurgitation and TAVR: Outcomes, Risk Factors and Biomarkers.

Background. The significance of concomitant tricuspid regurgitation (TR) in the context of transcatheter aortic valve replacement (TAVR) remains unclear. This study aimed to analyze the severity of TR before and after TAVR with regard to short- and long-term survival and to analyze the influencing factors. Methods. In our retrospective analysis, TR before and after TAVR was examined and patients were classified into groups accordingly. Special attention was paid to patients with post-interventional changes in TR. Mortality after TAVR was considered the primary endpoint of the analysis and major complications according to the Valve Academic Research Consortium 3 (VARC3) were compared. Moreover, biomarkers and risk factors for worsening or improvement of TR through TAVR were analyzed. Results. Among 775 patients who underwent TAVR in our center between January 2009 and December 2019, 686 patients (89%) featured low- and 89 patients (11%) high-grade TR. High-grade pre-TAVR TR was associated with worse short- (30-day), mid- (2-year) and long-term survival up to 8 years. Even though in nearly half of the patients with high-grade TR the regurgitation improved within seven days after TAVR (n = 42/89), this did not result in a survival benefit for this subgroup. On the other hand, a worsening of low-grade TR was seen in more than 10% of the patients (n = 73/686), which was also associated with a worse prognosis. Predictors of worsening of TR after TAVR were adipositas, impaired right ventricular function and the presence of mild TR. Age, atrial fibrillation, COPD, impaired renal function and elevated cardiac biomarkers were risk factors for mortality after TAVR independent from the grade of TR. Conclusions. Not only pre-interventional, but also post-TAVR high-grade TR is associated with a worse prognosis after TAVR. TAVR can change concomitant tricuspid regurgitation, but improvement does not have any impact on short- and long-term survival. Worsening of TR after TAVR is possible and impairs the prognosis.

Current definitions of hemodynamic structural valve deterioration after bioprosthetic aortic valve replacement lack consistency

ObjectiveNew echocardiographic definitions have been proposed for hemodynamic structural valve deterioration. We aimed to study their consistency in classifying structural valve deterioration after surgical aortic valve replacement. MethodsData were used of patients undergoing surgical aortic valve replacement in a multicenter, prospective cohort study with a 5-year follow-up. All patients received the same stented bioprosthesis. Echocardiographic parameters were assessed by an independent core laboratory. Moderate or greater stenotic hemodynamic structural valve deterioration was defined according to Capodanno and colleagues, Dvir and colleagues, and the Valve Academic Research Consortium 3; regurgitation data were not considered in this analysis. Consistency was quantified on the basis of structural valve deterioration classification at subsequent time points. ResultsA total of 1118 patients received implants. Patients’ mean age was 70 years, and 75% were male. Hemodynamic structural valve deterioration at any visit was present in 51 patients (4.6%), 32 patients (2.9%), and 34 patients (3.0%) according to Capodanno, Dvir, and Valve Academic Research Consortium 3. A total of 1064 patients (95%) were never labeled with structural valve deterioration by any definition. After the first classification with structural valve deterioration, 59%, 59%, and 65% had no subsequent structural valve deterioration classification according to Capodanno, Dvir, and Valve Academic Research Consortium 3, respectively. ConclusionsThe current definitions of hemodynamic structural valve deterioration are strong negative predictors but inconsistent positive discriminators for the detection of stenotic hemodynamic structural valve deterioration. Although the diagnosis of structural valve deterioration may be categorical, echocardiographic indices lack this degree of precision in the first 5 years after surgical aortic valve replacement. The inconsistency of current structural valve deterioration definitions impedes the detection of true valve degeneration, which challenges the clinical usefulness of these definitions.

Early outcomes of transapical mitral valve implantation versus surgical replacement in matched elderly patients at intermediate surgical risk.

Data comparing transcatheter mitral valve implantation (TMVI) with surgical mitral valve replacement (SMVR) are lacking. This study sought to compare the 30-day Valve Academic Research Consortium (VARC)-3 device success of TMVI with that of SMVR. Matching protocol combined exact matching (sex, atrial fibrillation, previous surgical aortic valve replacement [SAVR] or coronary artery bypass grafting [CABG]), coarsened exact matching (age) and propensity score matching (body mass index, mitral valve pathology and concomitant tricuspid regurgitation). A total of 40 Tendyne TMVI and 80 SMVR patients with similar baseline characteristics were analysed (TMVI vs SMVR): age (78 years [interquartile range [{IQR} 75; 80] vs 78 years [IQR 73; 80]; p=0.8), female (60% vs 60%; p=1.0), atrial fibrillation (67.5% vs 63.7%; p=0.8), previous SAVR (12.5% vs 10.0%; p=0.8), previous CABG (20.0% vs 16.2%; p=0.8), body mass index (25.54 kg/m² vs 25.24 kg/m²; p=0.7) and valve pathology (mitral regurgitation: 70.0% vs 73.8%, mitral stenosis: 7.5% vs 3.8%, and mixed disease: 22.5% vs 22.5%; p=0.6). Most baseline characteristics not included in the matching model were balanced among the TMVI/SMVR cohorts: European System for Cardiac Operative Risk Evaluation (EuroSCORE) II (5.8% [IQR 2.9; 7.5] vs 4.2% [IQR 2.4; 6.8]; p=0.3) and Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score (5.2% [IQR 3.2; 8.6] vs 4.1% [IQR 3.3; 6.1]; p=0.076). Coronary artery disease (67.5% vs 32.5%; p<0.001) and previous percutaneous coronary intervention (47.5% vs 25.0%; p=0.023) differed among groups. Mitral VARC (MVARC) device success at 30 days was achieved in 82.5% of patients after TMVI and 57.5% of patients after SMVR (p=0.04). MVARC procedural success at 30 days was 75.0% after TMVI versus 52.5% after SMVR (p=0.07). Thirty-day mortality (2.5% vs 3.8%; p=0.47), technical success (97.5% vs 97.5%; p=1.0), major bleeding (17.5% vs 18.7%; p=0.087), stroke (5.0% vs 4.9%; p=1.0) and postoperative haemodialysis (7.5% vs 5.2%; p=0.4) were similar in both groups. Patients with intermediate surgical risk, according to STS-PROM and EuroSCORE II, demonstrated higher rates of MVARC device at 30 days after TMVI compared to 30 days after SMVR. Rates of survival and procedural success, neurological, renal and bleeding complications were similar. Transfusion count and length of stay were lower after TMVI. For elderly patients at intermediate risk, a TMVI eligibility assessment may be considered.

Vascular complications and outcomes following transcatheter aortic valve replacement in patients on chronic steroid therapy: a meta-analysis.

Chronic steroid (CS) therapy was reportedly linked to increased vascular complications following percutaneous coronary intervention. However, its association with vascular complications after transcatheter aortic valve replacement (TAVR) remained uncertain, with conflicting results being reported. The authors aimed to compare the rate of vascular complications and outcomes between patients with and without CS use after TAVR. The authors conducted a comprehensive literature search in PubMed, Embase, and Cochrane databases from their inception until 18th April 2022 for relevant studies. Endpoints were described according to Valve Academic Research Consortium-2 definitions. Effect sizes were pooled using DerSimonian and Laird random-effects model as risk ratio (RR) with 95% CI. Five studies with 6136 patients undergoing TAVR were included in the analysis. The included studies were published between 2015 and 2022. The mean ages of patients in both study groups were similar, with the CS group averaging 80 years and the nonsteroid group averaging 82 years. Notably, a higher proportion of patients in the CS group were female (56%) compared to the nonsteroid group (54%). CS use was associated with a significantly higher risk of major vascular complications (12.5 vs. 6.7%, RR 2.32, 95% CI: 1.73-3.11, P <0.001), major bleeding (16.8 vs. 13.1%, RR 1.61, 95% CI: 1.27-2.05, P <0.001), and aortic annulus rupture (2.3 vs. 0.6%, RR 4.66, 95% CI: 1.67-13.01, P <0.001). There was no significant difference in terms of minor vascular complications (RR 1.43, 95% CI: 1.00-2.04, P =0.05), in-hospital mortality (2.3 vs. 1.4%, RR 1.86, 95% CI: 0.74-4.70, P =0.19), and 30-day mortality (2.9 vs. 3.1%, RR 1.14, 95% CI: 0.53-2.46, P =0.74) between both groups. Our study showed that CS therapy is associated with increased major vascular complications, major bleeding, and annulus rupture following TAVR. Further large multicenter studies or randomized controlled trials are warranted to validate these findings.

Navigating the challenges of minimally invasive mitral valve surgery: a risk analysis and learning curve evaluation

BackgroundThis study aimed to report the risk and learning curve analysis of a minimally invasive mitral valve surgery program performed through a right mini-thoracotomy at a single institution.MethodsFrom January 2013 through December 2019, 266 consecutive patients underwent minimally invasive mitral valve surgery in our department and were included in the current study. Multiple logistic regression analysis was used for the adverse event outcome. Distribution over time of perioperative complications, defined as clinical endpoints in the Valve Academic Research Consortium-2 (VARC-2) consensus document, as well as CUSUM charts for assessment of cardiopulmonary bypass and aortic cross-clamping duration over time, has been performed for learning curve assessment.ResultsOverall incidences of postoperative stroke (1.1%), myocardial infarction (1.1%), and thirty-day mortality (1.5%) were low. The mitral valve reconstruction rate in our series was 95%. Multivariable analysis revealed that concomitant tricuspid valve surgery (OR 4.44; 95%CI 1.61–11.80; p = 0.003) was significantly associated with adverse event outcomes. Despite a trend towards adverse event outcomes in patients with preexisting active mitral valve endocarditis (OR 2.69; 95%CI 0.81–7.87; p = 0.082), mitral valve pathology did not significantly impact postoperative morbidity and mortality. Distribution over time of perioperative complications, defined as clinical endpoints in the VARC-2 consensus document, showed a trend towards an improved complication rate after the initial 65–100 procedures.ConclusionsMitral valve surgery via right-sided mini-thoracotomy can be implemented safely with low perioperative morbidity and mortality rates. Careful patient selection regarding isolated mitral valve surgery in the presence of degenerative mitral valve disease may represent a significant safety issue during the learning curve.Trial Registration: The cantonal ethics commission of Zurich approved the study (registration ID 2020-00752, date of approval 24 April 2020).

Transcatheter Aortic Valve Replacement in Patients ≥80 and &lt;80 Years of Age with Aortic Valve Stenosis at Moderate Surgical Risk: Findings from an Observational Study in the Vietnamese Population

Objectives: The increasing number of elderly patients with severe aortic valve stenosis undergoing transcatheter aortic valve replacement (TAVR) has prompted concerns regarding their clinical outcomes compared with the younger population. This study evaluated the outcomes of TAVR on the basis of age group (&lt;80 or ≥80 years) among Vietnamese patients with severe aortic valve stenosis at intermediate surgical risk. Methods: From March 2017 to December 2022, 21 patients ≥80 years of age and 69 patients &lt;80 years of age underwent TAVI at a single center. Clinical characteristics, procedures, and outcomes at 30 days and 1 year were compared with the Valve Academic Research Consortium (VARC-2) criteria. Results: Patients ≥80 years of age had a higher prevalence of comorbidities but no significant differences in other clinical characteristics and procedures. No statistically significant differences were observed in procedural mortality (4.8% vs. 0.0%, P = 0.233), 30-day mortality (5.0% vs. 1.5%, P = 0.405), and 1-year mortality (11.8% vs. 3.7%, P = 0.241) between age groups. Major endpoints at specified time points also showed no significant differences. Conclusions: TAVR in patients with aortic stenosis at intermediate surgical risk has similar clinical outcomes at 30 days and 1 year, according to VARC-2 criteria, with no statistically significant age-associated differences (≥80 vs. &lt;80 years). However, further studies with larger patient populations are needed to better understand the effects of age on TAVI outcomes in patients with similar characteristics.

The role of external iliac artery diameter indexed to BSA score in predicting vascular access complications after transfemoral transcatheter aortic valve implantation.

Aortic stenosis is the most common primary valve disease and requires invasive treatment. Transcatheter aortic valve implantation (TAVI) from a transfemoral access is a routine intervention worldwide. To investigate the correlation between external iliac artery diameter (EIAD) indexed to body surface area (BSA) (EIAD-BSA) and access site complications in patients undergoing TAVI via transfemoral access (TF) (TF-TAVI). Patients underwent TF-TAVI in 2017-2019 at the Upper-Silesian Medical Center in Katowice. Based on the preoperative multi-slice computed tomography (MSCT), pre-specified measurements of the ilio-femoral vessels were performed. The results were indexed to BSA and body mass index (BMI). Complications after TAVI were defined by Valve Academic Research Consortium 3 (VARC-3). The primary outcome regarding the adverse events after TAVI was the composite of access site complications requiring surgical intervention or blood transfusion. The registry included 193 unselected patients with severe symptomatic aortic stenosis. Vascular and access-related complications including bleeding occurred in 17.1% of patients. Major TAVI access site complications (VARC-3) were reported in 5.7% of patients, while minor complications (VARC-3) occurred in 2.6%. EIAD-BSA demonstrated a positive correlation with the access site complications primary endpoint. Patients with greater EIAD-BSA had a numerically higher number of access site adverse events requiring surgical intervention or blood transfusion: n = 12 (5%) vs. n = 4 (4%), p = 0.011. External iliac artery diameter indexed to BSA could be an underestimated indicator of unfavorable outcomes after TF-TAVI, predicting periprocedural access site complications.

Preoperative computed tomography-imaging with patient-specific computer simulation in transcatheter aortic valve implantation: Design and rationale of the GUIDE-TAVI trial

Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with severe aortic valve stenosis, but is still associated with relatively high rates of pacemaker implantation and paravalvular regurgitation. Routine preoperative computed tomography (CT) combined with patient-specific computer modelling can predict the interaction between the TAVI device and the patient's unique anatomy, allowing physicians to assess the risk for paravalvular regurgitation and conduction disorders in advance to the procedure. The aim of this trial is to assess potential improvement in the procedural outcome of TAVI by applying CT-based patient-specific computer simulations in patients with suitable anatomy for TAVI. The GUIDE-TAVI trial is an international multicenter randomized controlled trial including patients accepted for TAVI by the Heart Team. Patients enrolled in the study will be randomized into 2 arms of each 227 patients. In patients randomized to the use of FEops HEARTGuide (FHG), patient-specific computer simulation with FHG is performed in addition to routine preoperative CT imaging and results of the FHG are available to the operator(s) prior to the scheduled intervention. In patients randomized to no use of FHG, only routine preoperative CT imaging is performed. The primary objective is to evaluate whether the use of FHG will reduce the incidence of mild to severe PVR, according to the Valve Academic Research Consortium 3. Secondary endpoints include the incidence of new conduction disorders requiring permanent pacemaker implantation, the difference between preoperative and final selected valve size, the difference between target and final implantation depth, change of preoperative decision, failure to implant valve, early safety composite endpoint and quality of life. The GUIDE-TAVI trial is the first multicenter randomized controlled trial to evaluate the value of 3-dimensional computer simulations in addition to standard preprocedural planning in TAVI procedures.

Outcomes of Transcatheter Aortic Valve Implantation under Transfemoral Approach Versus Alternative Approach in King Chulalongkorn Memorial Hospital

Background: The transfemoral approach (TF) is the access of choice for transcatheter aortic valve implantation (TAVI). However, approximately 10% of patients have anatomy or comorbidity unsuitable for TF. Objective: To analyze the outcomes of an alternative approach compared with TF in the authors’ institute. Materials and Methods: A retrospective analysis of patients undergoing TAVI in King Chulalongkorn Memorial Hospital between December 2010 and 2021 was conducted. The present study compared the baseline characteristics, outcomes, and complications of TAVI procedures, including one-year mortality, according to whether they were performed through a TF or alternative approach. Results: Among 210 patients that underwent TAVI, 188 (89.6%) were in the TF group and 22 (10.4%) were in the alternative group with seven in the trans-subclavian, nine in the transapical, and six in the transaortic. The mean age of the population was 81 years. Patients in the alternative group had more severe disease (median logistic EuroSCORE-II 19.67 versus 10.01, p&lt;0.001). Other baseline characteristics were not different between groups. According to the Valve Academic Research Consortium 3 (VARC-3) criteria, there were higher mortality and complication rates in the alternative group but no statistical differences regarding 30-day mortality of TF at 2.1% versus alternative at 9.1% (p=0.121) and 1-year mortality of TF at 5.3% versus alternative at 13.6% (p=0.143). Hospitalization times were significantly longer in the alternative group (median hospital stay in days of TF 4 versus alternative 10, p=0.013). Although no statistical significance was found, there were trends towards a higher rate of valve malpoition for TF at 3.7% versus alternative at 13.6%, and major vascular complications for TF at 1.6% versus alternative at 9.1%. Conclusion: The authors’ institute data demonstrates alternative approach TAVI was associated with a similar mortality rate and post-procedural complication rate compared with transfemoral TAVI, except for a trend toward a higher rate of valve malposition and major vascular complications. The alternative approach TAVI may be favored in patients with high or prohibitive surgical risk unsuitable for transfemoral TAVI. Keywords: Transcatheter aortic valve implantation; TAVI; Alternative approach; Transfemoral; Operative outcomes