Abstract
Aims
Transcatheter aortic valve implantation (TAVI) has emerged as established treatment option in patients with symptomatic aortic stenosis. Technical developments in valve design have ...addressed previous limitations such as suboptimal deployment, conduction disturbances, and paravalvular leakage. However, there are only limited data available for the comparison of newer generation self-expandable valve (SEV) and balloon-expandable valve (BEV).
Methods and results
SOLVE-TAVI is a multicentre, open-label, 2 × 2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral TAVI comparing SEV (Evolut R, Medtronic Inc., Minneapolis, MN, USA) with BEV (Sapien 3, Edwards Lifesciences, Irvine, CA, USA). The primary efficacy composite endpoint of all-cause mortality, stroke, moderate/severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days was powered for equivalence (equivalence margin 10% with significance level 0.05). The primary composite endpoint occurred in 28.4% of SEV patients and 26.1% of BEV patients meeting the prespecified criteria of equivalence rate difference −2.39 (90% confidence interval, CI −9.45 to 4.66); Pequivalence = 0.04. Event rates for the individual components were as follows: all-cause mortality 3.2% vs. 2.3% rate difference −0.93 (90% CI −4.78 to 2.92); Pequivalence < 0.001, stroke 0.5% vs. 4.7% rate difference 4.20 (90% CI 0.12 to 8.27); Pequivalence = 0.003, moderate/severe paravalvular leak 3.4% vs. 1.5% rate difference −1.89 (90% CI −5.86 to 2.08); Pequivalence = 0.0001, and permanent pacemaker implantation 23.0% vs. 19.2% rate difference −3.85 (90% CI −10.41 to 2.72) in SEV vs. BEV patients; Pequivalence = 0.06.
Conclusion
In patients with aortic stenosis undergoing transfemoral TAVI, newer generation SEV and BEV are equivalent for the primary valve-related efficacy endpoint. These findings support the safe application of these newer generation percutaneous valves in the majority of patients with some specific preferences based on individual valve anatomy.
In a multivariate binary logistic regression analysis, chronic hemodialysis (hazard ratio HR: 8.37; 95% confidence interval CI: 2.54 to 27.63; p < 0.001) and peripheral artery disease (HR: 3.77; 95% ...CI: 1.88 to 7.58; p < 0.001) remained the only independent predictors for developing IE. Negative imaging 15/47 (31.9) Total patients with affected prosthetic valve 22/47 (46.8) Vegetation only on prosthetic valve 12/47 (25.5) Vegetation on prosthetic valve and other valve 7/47 (14.9) Vegetation on prosthetic valve and PM/ICD lead 1/47 (2.1) Vegetation on prosthetic valve, PM/ICD lead and other valve 2/47 (4.3) Paravalvular abscess 9/47 (19.1) Vegetation on other valve than prosthetic valve 4/47 (8.5) Vegetation on PM/ICD lead 3/47 (6.4) Vegetation on PM/ICD lead and other valve 3/47 (6.4) Table 1 Characteristics of Patients Without and With Development of Infective Endocarditis Values are mean ± SD, median (interquartile range), or n (%).AR = aortic regurgitation; CKD = chronic kidney disease stage; COPD = chronic obstructive lung disease; ICD = implantable cardioverter-defibrillator; IE = infective endocarditis; PAD = peripheral artery disease; PM = pacemaker; STS = Society of Thoracic Surgeons; TOE = transesophageal echocardiography; ViV = valve-in-valve.
Red blood cell distribution width (RDW) is calculated in every blood count test and reflects variability in erythrocyte size. High levels mirror dysregulated erythrocyte homeostasis and have been ...associated with clonal hematopoiesis as well as higher mortality in several conditions.
We aimed to determine the impact of preprocedural RDW levels on functional outcomes after transcatheter aortic valve implantation (TAVI).
In this single-center retrospective study, we analyzed 176 consecutive patients receiving TAVI between 2017 and 2021. RDW upper limit of normal was < 15 %. Patients were stratified according to preprocedural RDW as having normal or elevated values. We assessed all-cause-mortality and a composite endpoint comprising cardiovascular/ valve-related mortality and cardiovascular, valve-related and heart failure hospitalization at 1 year.
43 patients (24.4 %) had RDW ≥ 15 %. There were significant baseline differences between groups (Society of Thoracic Surgeons – Predicted Risk of Mortality score 3.18 %interquartile range 1.87–5.47 vs. 6.63 %4.12–10.54 p < 0.001; hemoglobin 13.2 g/dL11.8–14.1 vs. 10.4 g/dL9.8–12.2, p < 0.001, RDW-normal vs. RDW-high, respectively). Age was not distinct (80.2 years 77.5–84.1 vs 81.271.3–84.7, p = 0.78). 1-year-all-cause mortality was not different (7.9 % vs. 9.4 %, p = 0.79). The RDW-high group showed markedly higher NT-proBNP levels after 1 year (647 ng/ml283–1265 vs. 1893 ng/ml744–5109, p = 0.005), and experienced more clinical endpoints (hazard ratio 2.571.28–5.16 for the composite endpoint, p = 0.006). RDW remained an independent predictor of the composite endpoint when accounting for all baseline differences in multivariable regression.
Elevated preprocedural RDW identifies patients at risk for impaired functional outcome after TAVI and may represent a useful low-cost parameter to guide intensity of outpatient surveillance strategies.
Background
Impaired left ventricular (LV) ejection fraction is a common finding in patients with aortic stenosis and serves as a predictor of morbidity and mortality after transcatheter aortic valve ...replacement. However, conflicting data on the most accurate measure for LV function exist. We wanted to examine the impact of LV ejection fraction, mean pressure gradient, and stroke volume index on the outcome of patients treated by transcatheter aortic valve replacement.
Methods and Results
Patients treated by transcatheter aortic valve replacement were primarily separated into normal flow (NF; stroke volume index >35 mL/m2) and low flow (LF; stroke volume index ≤35 mL/m2). Afterwards, patients were divided into 5 groups: “NF–high gradient,” “NF–low gradient” (NF‐LG), “LF–high gradient,” “paradoxical LF‐LG,” and “classic LF‐LG.” The 3‐year mortality was the primary end point. Of 1600 patients, 789 (49.3%) were diagnosed as having LF, which was characterized by a higher 30‐day (P=0.041) and 3‐year (P<0.001) mortality. LF was an independent predictor of all‐cause (hazard ratio, 1.29; 95% confidence interval, 1.03–1.62; P=0.03) and cardiovascular (hazard ratio, 1.37; 95% confidence interval, 1.06–1.77; P=0.016) mortality. Neither mean pressure gradient nor LV ejection fraction was an independent predictor of mortality. Patients with paradoxical LF‐LG (35.0%), classic LF‐LG (35.1%) and LF–high gradient (38.1%) had higher all‐cause mortality at 3 years compared with NF–high gradient (24.8%) and NF‐LG (27.9%) (P=0.001). However, surviving patients showed a similar improvement in symptoms regardless of aortic stenosis entity.
Conclusions
LF is a common finding within the aortic stenosis population and, in contrast to LV ejection fraction or mean pressure gradient, an independent predictor of all‐cause and cardiovascular mortality. Despite increased long‐term mortality, high procedural success and excellent functional improvement support transcatheter aortic valve replacement in patients with LF severe aortic stenosis.
Background Infective endocarditis ( IE ) after transcatheter aortic valve replacement is a devastating complication associated with a high mortality. Our objective was to determine the impact of ...cardiac surgery (CS) and antibiotics ( IE - CS ) compared with medical treatment with antibiotics only ( IE - AB x) on 1-year mortality in patients developing IE after transcatheter aortic valve replacement. Methods and Results Patients developing IE after transcatheter aortic valve replacement were included in this retrospective analysis. All-cause 1-year mortality was the primary end point. A total of 20 patients underwent IE - CS compared with 44 patients treated by IE - AB x. In this unmatched cohort, patients treated by IE - AB x were older ( P=0.006), had a higher Society of Thoracic Surgeons score ( P=0.029), and more often had severe chronic kidney disease ( P=0.037). One-year mortality was not different between groups ( IE -CS versus IE-ABx, 65% versus 68.2%; P=0.802). The rate of any complication during treatment was higher in the IE - CS group ( P=0.024). In a matched cohort, baseline characteristics were not significantly different. All-cause 1-year mortality was not different between groups ( IE -CS versus IE-ABx, 65% versus 75%; P=0.490). A Cox regression analysis revealed any indication for surgery (hazard ratio, 6.20; 95% confidence interval, 1.80-21.41; P=0.004), sepsis on admission (hazard ratio, 4.03; 95% confidence interval, 1.97-8.24; P<0.001), and mitral regurgitation ≥2 (hazard ratio, 2.91; 95% confidence interval, 1.33-6.37) as factors associated with 1-year mortality. Conclusions In patients developing IE after transcatheter aortic valve replacement, mortality was predicted by the severity of IE and concomitant mitral regurgitation. In this small, and therefore statistically limited, but high-risk patient cohort, CS provided no significant mortality benefit compared with medical therapy. Individual decision making by a "heart and endocarditis team" is necessary to offer those patients the most reasonable treatment option.
Background
Patients undergoing transcatheter aortic valve replacement (TAVR) are often characterized by risk factors not reflected in conventional risk scores. In this context, little is known about ...the outcome of patients suffering from an active cancer disease (ACD). The objective was to determine the prevalence, clinical characteristics, perioperative outcomes, and mortality of patients with ACD undergoing TAVR compared to those with a history of cancer (HCD) and controls without known tumor disease.
Methods
TAVR patients between 02/2006 and 09/2014 were stratified according to the presence of ACD, HCD, and control. All‐cause‐mortality at 1‐year was the primary end point. All end point definitions were subject to the Valve Academic Research Consortium II definitions.
Results
Overall, 1821 patients were included: 99 patients (5.4%) suffered from ACD and 251 patients (13.8%) had HCD. ACD was related to a solid organ or hematological source in 72.7% and 27.3%, respectively. Patients with ACD were more often male (P = 0.004) and had a lower logisticEuroScore I (P = 0.033). Overall rates of VARC‐II defined periprocedural myocardial infarction, stroke, bleeding, access‐site complications, and acute kidney injury were not different between groups. Thirty‐day mortality did not differ between patients with ACD, HCD, and controls (6.1% vs 4.4% vs 7.6%, P = 0.176). All‐cause 1‐year mortality was higher in patients with ACD compared HCD and controls (37.4% vs 16.4% vs 20.8%, P < 0.001). ACD was an independent predictor of all‐cause 1‐year mortality (HR 2.10, 95%‐CI 1.41‐3.13, P < 0.001).
Conclusion
The presence of ACD in patients undergoing TAVR is associated with significantly higher 1‐year mortality.
Background As transcatheter aortic valve replacement (TAVR) is expected to progress into younger patient populations, valve-in-TAVR (ViTAVR) may become a frequent consideration. Data on ViTAVR, ...however, are limited. This study investigated the outcome of ViTAVR in comparison to valve in surgical aortic valve replacement (ViSAVR), because ViSAVR is an established procedure for higher-risk patients requiring repeated aortic valve intervention. Methods and Results Clinical and procedural data of patients who underwent ViTAVR at 3 sites in the United States and Germany were retrospectively compared with data of patients who underwent ViSAVR at Cedars-Sinai Medical Center, according to Valve Academic Research Consortium-2 criteria. A total of 99 consecutive patients, 52.5% women, with a median Society of Thoracic Surgeons score of 7.2 were identified. Seventy-four patients (74.7%) underwent ViSAVR, and 25 patients (25.3%) underwent ViTAVR. Balloon-expandable devices were used in 72.7%. ViSAVR patients presented with smaller index devices (21.0 versus 26.0 mm median true internal diameter;
<0.001). Significantly better postprocedural hemodynamics (median prosthesis mean gradient, 12.5 interquartile range, 8.8-16.2 versus 16.0 interquartile range, 13.0-20.5 mm Hg;
=0.045) were observed for ViTAVR compared with the ViSAVR. Device success, however, was not different (79.2% and 66.2% for ViTAVR and ViSAVR, respectively;
=0.35), as were rates of permanent pacemaker implantation (16.7% versus 5.4%;
=0.1). One-year-mortality was 9.4% and 13.4% for ViTAVR and ViSAVR, respectively (log-rank
=0.38). Conclusions Compared with ViSAVR, ViTAVR provides acceptable outcomes, with slightly better hemodynamics, similar device success rates, and similar 1-year mortality.
We evaluated the outcome of PCI of de novo stenosis with drug-coated balloons (DCB) versus drug-eluting stents (DES) in patients with insulin-treated diabetes mellitus (ITDM) versus ...non-insulin-treated diabetes mellitus (NITDM).
Patients were randomized in the BASKET-SMALL 2 trial to DCB or DES and followed over 3 years for MACE (cardiac death, non-fatal myocardial infarction MI, and target vessel revascularization TVR). Outcome in the diabetic subgroup (
= 252) was analyzed with respect to ITDM or NITDM.
In NITDM patients (
= 157), rates of MACE (16.7% vs. 21.9%, hazard ratio HR 0.68, 95% confidence interval CI 0.29-1.58,
= 0.37), death, non-fatal MI, and TVR (8.4% vs. 14.5%, HR 0.30, 95% CI 0.09-1.03,
= 0.057) were similar between DCB and DES. In ITDM patients (
= 95), rates of MACE (DCB 23.4% vs. DES 22.7%, HR 1.12, 95% CI 0.46-2.74,
= 0.81), death, non-fatal MI, and TVR (10.1% vs. 15.7%, HR 0.64, 95% CI 0.18-2.27,
= 0.49) were similar between DCB and DES. TVR was significantly lower with DCB versus DES in all diabetic patients (HR 0.41, 95% CI 0.18-0.95,
= 0.038).
DCB compared to DES for treatment of de novo coronary lesions in diabetic patients was associated with similar rates of MACE and numerically lower need for TVR both for ITDM and NITDM patients.
Transcatheter aortic valve replacement (TAVR) has become the standard of care in the majority of patients with symptomatic severe aortic stenosis. Data on long-term mortality and durability of ...transcatheter heart valves (THVs) beyond 5 years are limited. Our study aimed to assess elderly and high-risk patients’ long-term outcomes treated with TAVR in a prospective single-centre registry focusing on the durability of THVs.
We included 795 patients with severe calcific aortic stenosis treated by transfemoral TAVR between 2006 and 2011. Echocardiography was performed at baseline; discharge; 1 year; and afterward, annually, until the longest available follow-up. Mortality rates were estimated for 1, 5, 6, 7, and 8 years. The rates of structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) were assessed in accordance with consensus definitions. Outcome measures were adjudicated according to Valve Academic Research Consortium-2 (VARC-2).
Median (interquartile range) follow-up time was 1345 (316; 2015) days. One-year, 5-year, 6-year, 7-year, and 8-year overall mortality was 25.4%, 59.0%, 64.6%, 67.9%, and 69.2%, respectively. At 8 years, no significant differences in mortality were found comparing self-expanding vs balloon-expandable valves (69.5% vs 68.0%, P = 0.709) and postdilatation (PD) vs no-PD (69.4% vs 69.2%, P = 0.363). SVD was detected in 26 patients (3.3%), and 19 (2.4%) of the 795 patients had evidence of BVF during follow-up.
Our study demonstrates good long-term results for high-risk patients who were alive up to 8 years after TAVR.
Le remplacement valvulaire aortique par cathéter (RVAC) est maintenant la norme de soins dans la majorité des cas de sténose de l’aorte grave symptomatique. On dispose de peu de données sur la mortalité à long terme et sur la durabilité des valves cardiaques transcathéter (VCT) au-delà de 5 ans. Nous avons donc évalué les résultats à long terme, notamment la durabilité des VCT, chez les patients âgés et les patients exposés à un risque élevé traités par RVAC figurant dans un registre prospectif unicentrique.
Notre étude comprenait 795 patients présentant une sténose calcifiée de l’aorte grave traitée par RVAC transfémoral entre 2006 et 2011. Une échocardiographie a été réalisée au départ, à la sortie de l’hôpital, 1 an plus tard et tous les ans par la suite, jusqu’au suivi le plus long disponible. Les taux de mortalité à 1, 5, 6, 7 et 8 ans ont été estimés. Les taux de détérioration structurelle des valves (DSV) et de défaillance de la bioprothèse valvulaire (DBV) ont été évalués selon des définitions établies par consensus. Les mesures des résultats ont été confirmées selon les critères du VARC-2 (Valve Academic Research Consortium-2).
La durée médiane (intervalle interquartile) du suivi était de 1 345 (316 à 2 015) jours. Les taux de mortalité globaux s’établissaient comme suit : taux à 1 an : 25,4 %; à 5 ans : 59,0 %; à 6 ans : 64,6 %; à 7 ans : 67,9 % et à 8 ans : 69,2 %. À 8 ans, on n’a noté aucune différence significative en ce qui concerne la mortalité chez les patients ayant reçu une valve auto-expansible comparativement à ceux ayant reçu une valve expansible par ballonnet (69,5 % vs 68,0 %; p = 0,709) et chez ceux ayant subi une post-dilatation ou non (69,4 % vs 69,2 %; p = 0,363). Une DSV a été détectée chez 26 patients (3,3 %), et 19 (2,4 %) des 795 patients ont présenté des signes de DBV pendant la période de suivi.
Notre étude a révélé de bons résultats à long terme chez les patients présentant un risque élevé qui étaient toujours en vie 8 ans après le RVAC.
BACKGROUND:In clinical practice, local anesthesia with conscious sedation (CS) is performed in roughly 50% of patients undergoing transcatheter aortic valve replacement. However, no randomized data ...assessing the safety and efficacy of CS versus general anesthesia (GA) are available.
METHODS:The SOLVE-TAVI (Comparison of Second-Generation Self-Expandable Versus Balloon-Expandable Valves and General Versus Local Anesthesia in Transcatheter Aortic Valve Implantation) trial is a multicenter, open-label, 2×2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement comparing CS versus GA. The primary efficacy end point was powered for equivalence (equivalence margin 10% with significance level 0.05) and consisted of the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury at 30 days.
RESULTS:The primary composite end point occurred in 27.2% of CS and 26.4% of GA patients (rate difference, 0.8 90% CI, −6.2 to 7.8; Pequivalence=0.015). Event rates for the individual components were as followsall-cause mortality, 3.2% versus 2.3% (rate difference, 1.0 90% CI, −2.9 to 4.8; Pequivalence<0.001); stroke, 2.4% versus 2.8% (rate difference, −0.4 90% CI, −3.8 to 3.8; Pequivalence<0.001); myocardial infarction, 0.5% versus 0.0% (rate difference, 0.5 90% CI, −3.0 to 3.9; Pequivalence<0.001), infection requiring antibiotics 21.1% versus 22.0% (rate difference, −0.9 90% CI, −7.5 to 5.7; Pequivalence=0.011); acute kidney injury, 9.0% versus 9.2% (rate difference, −0.2 90% CI, −5.2 to 4.8; Pequivalence=0.0005). There was a lower need for inotropes or vasopressors with CS (62.8%) versus GA (97.3%; rate difference, −34.4 90% CI, −41.0 to −27.8).
CONCLUSIONS:Among patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement, use of CS compared with GA resulted in similar outcomes for the primary efficacy end point. These findings suggest that CS can be safely applied for transcatheter aortic valve replacement.
REGISTRATION:URLhttps://www.clinicaltrials.gov; Unique identifierNCT02737150.
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