Transcatheter aortic valve replacement (TAVR) has emerged as an alternative to surgical aortic valve replacement (SAVR), but unbiased data regarding evolution of the treatment of patients with aortic ...stenosis at the nationwide level are scarce.
This study sought to evaluate the number of aortic valve replacements (AVRs) performed in France, changes over time, and the effect of the adoption of TAVR.
Based on a French administrative hospital-discharge database, the study collected all consecutive AVRs performed in France between 2007 and 2015.
A total of 131,251 interventions were performed: 109,317 (83%) SAVR and 21,934 (17%) TAVR. AVR linearly increased (from 10,892 to 18,704; p for trend <0.0001) mainly due to a marked increase in TAVR (from 244 to 6,722; p for trend = 0.0004), whereas SAVR remained stable (from 10,892 to 11,982; p for trend = 0.18). Parallel to a decrease in the Charlson index (p for trend <0.05), SAVR and TAVR in-hospital mortality rates significantly declined (both p for trend <0.01). The number of TAVRs significantly increased in all age categories (<75, 75 to 79, 80 to 84, and ≥85 years of age; all p for trend = 0.003), but reached or even exceeded SAVR in the 2 oldest categories. Although mortality rates declined for both isolated SAVR and TAVR, it became similar or slightly lower for TAVR than for isolated SAVR in 2015 in the 3 oldest age categories even if it did not reach statistical significance (p = 0.66, p = 0.47, and p = 0.06, respectively).
The number of AVRs markedly increased in France between 2007 and 2015 due to the wide adoption of TAVR, which represented one-third of all AVRs in 2015. Patients’ profile improved, suggesting that patients are referred earlier, and in-hospital mortality declined in all AVR subsets. Despite a worse clinical profile, the immediate outcome of TAVR compared favorably to isolated SAVR in patients >75 years of age. The results may have major implications for clinical practice and policymakers.
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Femoral access is the gold standard for transcatheter aortic valve replacement (TAVR). Guidelines recommend reconsidering surgery when this access is not feasible. However, alternative peripheral ...accesses exist, although they have not been accurately compared with femoral access.
This study compared nonfemoral peripheral (n-FP) TAVR with femoral TAVR.
Using the data from the national prospective French registry (FRANCE TAVI French Transcatheter Aortic Valve Implantation), this study compared the characteristics and outcomes of TAVR procedures according to whether they were performed through a femoral or a n-FP access, using a pre-specified propensity score−based matching between groups. Subanalysis during 2 study periods (2013 to 2015 and 2016 to 2017) and among low/intermediate-low and intermediate-high/high volume centers were performed.
Among 21,611 patients, 19,995 (92.5%) underwent femoral TAVR and 1,616 (7.5%) underwent n-FP TAVR (transcarotid, n = 914 or trans-subclavian, n = 702). Patients in the n-FP access group had more severe disease (mean logistic EuroSCORE 19.95 vs. 16.95; p < 0.001), with a higher rate of peripheral vascular disease, known coronary artery disease, chronic pulmonary disease, and renal failure. After matching, there was no difference in the rate of post-procedural death and complications according to access site, except for a 2-fold lower rate of major vascular complications (odds ratio: 0.45; 95% confidence interval: 0.21 to 0.93; p = 0.032) and unplanned vascular repairs (odds ratio: 0.41; 95% confidence interval: 0.29 to 0.59; p < 0.001) in those who underwent n-FP access. The comparison of outcomes provided similar results during the second study period and in intermediate-high/high volume centers.
n-FP TAVR is associated with similar outcomes compared with femoral peripheral TAVR, except for a 2-fold lower rate of major vascular complications and unplanned vascular repairs. n-FP TAVR may be favored over surgery in patients who are deemed ineligible for femoral TAVR and may be a safe alternative when femoral access risk is considered too high.
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The “obesity paradox” that patients with high body mass index (BMI) have good prognoses remains controversial. This study aimed to assess the impact of BMI on clinical outcomes in patients who ...underwent transcatheter aortic valve implantation (TAVI). Data from the French national TAVI registry were collected for 3,072 patients who underwent TAVI from January 2010 to October 2011. The patients were categorized into 4 groups according to BMI (kg/m2 ): underweight (<18.5 kg/m2 ), normal weight (18.5 to 25 kg/m2 ), overweight (25 to 30 kg/m2 ), and obese (>30 kg/m2 ). Thereafter, clinical outcomes were compared among the 4 groups. The BMI distribution was 3.1% (n = 95), 44.1% (n = 1,355), 34.2% (n = 1,050), and 18.6% (n = 572). Although the 4 groups greatly differed in baseline clinical background, they had similar procedural success rates (95.8%, 97.1%, 97.3%, and 95.6%, p = 0.23). Major vascular complication was significantly associated with the underweight patients after adjusting for the other potential confounders (odds ratio 2.33, 95% confidence interval 1.17 to 4.46, p = 0.016). The cumulative postoperative survival rates were increasing across the 4 groups at 30 days (83.2%, 88.9%, 91.6%, and 93.0%, p = 0.003) and 1 year (67.9%, 73.6%, 77.4%, and 80.3%, p = 0.006). In a multivariate Cox regression analysis, the overweight and obese patients were independently associated with superior cumulative survival rate at 1 year (hazard ratios 0.74 and 0.71, 95% confidence intervals 0.57 to 0.97 and 0.59 to 0.87, p = 0.050 and 0.029, respectively). In conclusion, major morbidity and 1-year mortality were less in overweight and obese patients than those classified as normal weight even in a TAVI cohort.
Cryoballoon ablation is currently the gold standard technique for single-shot pulmonary vein isolation (PVI). Pulsed field ablation (PFA) has recently emerged as an interesting nonthermal alternative ...energy for PVI. The purpose of our study was to evaluate the safety and long-term efficacy of PVI using the pentaspline PFA catheter in comparison to cryoballoon ablation.
Between January 2021 and December 2022, we included all consecutive patients of our center in whom a first PVI-only procedure was performed using PFA or cryoballoon. The choice of the energy was based on patients' preference between general anesthesia (PFA) and local anesthesia (cryoballoon). The primary end point was freedom from documented atrial arrhythmia recurrence after a 3-month blanking period. A total of 301 patients (paroxysmal atrial fibrillation in 220 patients) underwent a first PVI procedure performed using PFA (n=151) or cryoballoon (n=150). Complete short-term PVI was obtained in 144 of 150 patients (96%) in the cryoballoon group and in all patients of the PFA group (
=0.01). Procedure duration was significantly longer in the cryoballoon group. Transient and persistent phrenic nerve injuries were observed in the cryoballoon group only (13/150 and 2/150, respectively). One-year freedom from atrial arrhythmia was significantly higher in the PFA group compared with the cryoballoon group (87.9% versus 77.7%; adjusted hazard ratio, 0.53 95% CI, 0.30-0.96;
=0.037).
This prospective, comparative, real-life study suggested that PFA could overcome safety limitations of cryoballoon with optimal effectiveness. Randomized controlled studies are required to further investigate the potential superiority of PFA over cryoballoon.
Background Although transcatheter aortic valve implantation has been developing as an alternative treatment in elderly patients with high surgical risk, age-specific differences in clinical outcome ...have not been fully validated. Methods Data were analyzed for 2,254 patients at least 80 years old who were enrolled between January 2010 and October 2011 in the French national transcatheter aortic valve implantation registry, FRANCE-2. Procedural and clinical outcomes defined according to the Valve Academic Research Consortium criteria were compared among subjects in three age groups: 80 to 84 years (n = 867), 85 to 89 years (n = 1,064), and at least 90 years (n = 349; range, 90 to 101 years). Results The self-expandable prosthesis was implanted in 710 patients, and the balloon-expandable prosthesis was implanted in 1,544 patients. No differences were observed in rates of procedural success, Valve Academic Research Consortium–defined complications, and length of hospitalization among groups. Cumulative 30-day mortalities did not change among the three groups (80 to 84 years, 10.3% versus 85 to 89 years, 9.5% versus ≥90 years, 11.2%; p = 0.53). Cumulative 1-year mortalities also showed no statistical differences, although the mortality rate was higher in patients 85 to 89 years old and at least 90 years old compared with those 80 to 84 years old (19.8% versus 26.1% versus 27.7%; p = 0.16). After adjustment for differential baseline characteristics and potential confounders, patient age (85 to 89 years and ≥90 years compared with 80 to 84 years) was not associated with increasing risk of 30-day mortality (hazard ratio, 0.92, 1.26; 95% confidence interval, 0.66 to 1.27, 0.83 to 1.94; p = 0.38, 0.28, respectively) and 1-year mortality (hazard ratio, 1.16, 1.36; 95% confidence interval, 0.90 to 1.49, 0.97 to 1.89; p = 0.25, 0.073, respectively). Conclusions This study revealed acceptable clinical results of transcatheter aortic valve implantation even in very elderly populations.
As transcatheter aortic valve implantation (TAVI) becomes more routinely used, the recommended duration of monitoring after uncomplicated TAVI remains indeterminate. Retrospective analysis suggests ...that discharge within 72 hours is safe, but prospective data are largely lacking. We therefore prospectively assess the feasibility and safety of early discharge (within 72 hours) after transfemoral TAVI using Edwards SAPIEN-XT and SAPIEN-3 prostheses. Patients undergoing elective transfemoral TAVI were assessed prospectively for early discharge home. Feasibility and safety (death or repeat hospitalization within 30 days of discharge) of early discharge were assessed. Causes for failure of early discharge were assessed by prospective data collection and multivariate analysis. Of 130 patients, 76 (59%) were discharged early. Death or repeat hospitalization within 30 days occurred only in 4 cases (5%) among patients who discharged early: repeat hospitalization within 30 days was required in 3 early-discharge patients (4%), and there was a single death at 30 days. By multivariate analysis, factors associated with delayed discharge were blood transfusion (hazard ratio 13.85, 95% CI 1.61 to 119.40, p = 0.017) and pacemaker implantation (hazard ratio 4.47, 95% CI 1.34 to 14.26, p = 0.012). In conclusion, early discharge after elective transfemoral TAVI with SAPIEN-XT/SAPIEN-3 prostheses is safe and attainable in a large proportion of patients, with no evident compromise in safety. Factors associated with failure of early discharge are postprocedural blood transfusion and permanent pacemaker implantation.
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