In-hospital outcomes and cost-effectiveness of transcatheter aortic valve replacement among younger patients: a double/debiased machine learning approach using electronic health records in Germany.

1-Year Outcomes After Transfemoral Transcatheter or Surgical Aortic Valve Replacement: Results From the Italian OBSERVANT Study

On 16 April 2002, my colleagues and I performed, in an inoperable and desperately ill man with critical calcific aortic stenosis (AS), the first clinical percutaneous implantation of an aortic valve bioprosthesis. As of 2013, more than 80,000 patients have been treated; and transcatheter aortic valve replacement (TAVR), so strongly criticized by all the experts throughout the early years, continues to grow in parallel with its constant technological improvements. Transcatheter aortic valve replacement can now be recognized as a medical breakthrough. It is a revolutionary technology that meets an unfulfilled clinical need for a common disease, is validated by rigorous evidence-based studies, and is applicable worldwide. We report here the main phases of this 20-year odyssey and briefly consider the prospects of TAVR, which remains in continuous development.

Comment on “1-year outcomes after transfemoral transcatheter or surgical aortic valve replacement. Results from the Italian OBSERVANT study”

Commentary: An all-access pass to transcatheter aortic valve replacement

Decreasing Prices but Increasing Demand for Transcatheter Aortic Valve Replacement.

Comparison of Outcomes and Discharge Location After Transcatheter vs. Surgical Aortic Valve Replacement With Prior Coronary Artery Bypass Grafting

Recent randomized trials have documented the superiority of TAVR-particularly via transfemoral access-over SAVR in patients with severe aortic stenosis considered to have a high or intermediate operative risk of death. We sought to assess in-hospital outcomes of patients with severe aortic stenosis and a low risk of operative mortality undergoing routine surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). We performed a propensity-score matched comparison of all patients undergoing first-time treatment by SAVR or transfemoral TAVR (TF-TAVR) in 2014 in Germany who had a logistic EuroSCORE (logES) ≤ 10%, considered to reflect low surgical risk. The primary endpoint of our analysis was in-hospital mortality. Of 7624 SAVR and 9969 TF-TAVR procedures, 6844 (89.8%) and 2751 patients (27.6%), respectively, were considered low risk with a logES between 1.505 and 10.0%. Matching yielded 805 TF-TAVR/SAVR patient pairs with identical propensity scores and no difference in pertinent baseline characteristics, except for the logES, which was significantly higher in TF-TAVR patients (6.8 ± 1.7 vs. 4.2 ± 1.3% in SAVR patients, P < 0.001). Observed in-hospital mortalities were 1.7% (95% confidence interval, 1.1-3.0%) in SAVR and 2.0% (1.3-3.3%) in TF-TAVR patients (P = 0.85). Our finding of no difference in in-hospital mortality in propensity-score matched low-surgical-risk patients treated by SAVR or TF-TAVR in a routine clinical setting indicates that TF-TAVR can be offered safely to individual patients, despite their operative risk being low. This finding needs to be confirmed in a randomized trial.

BackgroundThe treatment of aortic stenosis is evolving rapidly. Pace of change in the care of patients undergoing transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) differs. We sought to determine differences in temporal changes in 30‐day mortality, 30‐day readmission, and length of stay after TAVR and SAVR.Methods and ResultsWe conducted a retrospective cohort study of patients treated in the United States between 2012 and 2019 using data from the Medicare Data Set Analytic File 100% Fee for Service database. We included consecutive patients enrolled in Medicare Parts A and B and aged ≥65 years who had SAVR or transfemoral TAVR. We defined 3 study cohorts, including all SAVR, isolated SAVR (without concomitant procedures), and elective isolated SAVR and TAVR. The primary end point was 30‐day mortality; secondary end points were 30‐day readmission and length of stay. Statistical models controlled for patient demographics, frailty measured by the Hospital Frailty Risk Score, and comorbidities measured by the Elixhauser Comorbidity Index (ECI). Cox proportional hazard models were developed with TAVR versus SAVR as the main covariates with a 2‐way interaction term with index year. We repeated these analyses restricted to full aortic valve replacement hospitals offering both SAVR and TAVR. The main study cohort included 245 269 patients with SAVR and 188 580 patients with TAVR, with mean±SD ages 74.3±6.0 years and 80.7±6.9 years, respectively, and 36.5% and 46.2% female patients, respectively. Patients with TAVR had higher ECI scores (6.4±3.6 versus 4.4±3) and were more frail (55.4% versus 33.5%). Total aortic valve replacement volumes increased 61% during the 7‐year span; TAVR volumes surpassed SAVR in 2017. The magnitude of mortality benefit associated with TAVR increased until 2016 in the main cohort (2012: hazard ratio [HR], 0.76 [95% CI, 0.67–0.86]; 2016: HR, 0.39 [95% CI, 0.36–0.43]); although TAVR continued to have lower mortality rates from 2017 to 2019, the magnitude of benefit over SAVR was attenuated. A similar pattern was seen with readmission, with a lower risk of readmission from 2012 to 2016 for patients with TAVR (2012: HR, 0.68 [95% CI, 0.63–0.73]; 2016: HR, 0.43 [95% CI, 0.41–0.45]) followed by a lesser difference from 2017 to 2019. Year over year, TAVR was associated with increasingly shorter lengths of stay compared with SAVR (2012: HR, 1.91 [95% CI, 1.84–1.98]; 2019: HR, 5.34 [95% CI, 5.22–5.45]). These results were consistent in full aortic valve replacement hospitals.ConclusionsThe rate of improvement in TAVR outpaced SAVR until 2016, with the recent presence of U‐shaped phenomena suggesting a narrowing gap between outcomes. Future longitudinal research is needed to determine the long‐term implications of lowering risk profiles across treatment options to guide case selection and clinical care.

Transfemoral transcatheter aortic valve replacement (TAVR) was superior to surgical aortic valve replacement (SAVR) in the placement of aortic transcatheter valves (PARTNER) 2A trial (P2). The generalizability of the trial results to the broader population of patients with intermediate surgical risk remains unknown. To compare the outcomes of SAVR and TAVR among patients with intermediate surgical risk treated in the VA Healthcare System. We retrospectively analyzed the clinical characteristics and outcomes on all SAVR (1987-2014) and TAVR procedures (2015-2017) performed at the Minneapolis VA Healthcare System. Patients were divided into three groups based on their estimated 30-day mortality risk. The primary outcome was a composite of death or stroke at 30-days. A total of 1,049 patients underwent SAVR with (n = 468, 45%) or without CABG (n = 581, 55%) and 110 underwent TAVR during the study period. Intermediate-risk patients represented 29.4% and 40% of patients undergoing SAVR and TAVR, respectively. The predicted 30-day mortality risk of intermediate-risk patients was 5.5% for the SAVR group and 5.2% for the TAVR group (P = 0.54). The observed combined rate of stroke or death at 30-days for intermediate-risk patients treated with SAVR and TAVR was 11% and 2.2%, respectively (P = 0.05). The results for SAVR and TAVR at the VA were comparable to the P2 trial and STS database (all P = NS). The results did not change when the analysis was restricted to a more contemporary (2005-2014) surgical cohort or isolated SAVR. The number needed to treat to prevent one death/stroke with TAVR was 10. Adoption of TAVR as the preferred treatment modality in intermediate-risk patients may result in significant improvements in morbidity and mortality.

We aimed to determine and compare the prevalence, and predictors of readmissions after the transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). There are limited data on the readmission rates after TAVR in comparison with SAVR. We analyzed the data from 2013 National Readmission Database. Propensity-matched pairs were used to analyze differences in readmission rates between TAVR and SAVR for patients aged ≥65. A total of 24,020 (TAVR-transfemoral 3,469, TAVR-transapical 1,433, SAVR 19,118) patients were included. The readmission rates were not statistically different for all propensity-matched TAVR and SAVR patients (17.2% vs. 20.6%, P = 0.28). However, in subgroup analysis, transapical TAVR had the highest readmission rate (22.8% vs. 16.5% vs. 16.0%, P < 0.001, respectively) and readmission leading to death (7.1% vs. 5.3% vs. 3.9%, P = 0.022, respectively) when compared with transfemoral TAVR and SAVR. In all the groups, two-thirds of readmissions were due to noncardiac causes. Congestive heart failure (CHF) and arrhythmia were the most frequent cardiac etiologies. The independent predictors of readmission were female sex, CHF, and chronic obstructive pulmonary disease. Patients who received care in teaching hospitals had lower probability of readmission. One of six patients were readmitted within 30 days after the aortic valve replacement. On propensity score analysis, there were no significant differences between the early readmission rates between TAVR and SAVR groups. However, the patients undergoing transapical TAVR were at higher risk for readmission, and subsequent deaths when compared with transfemoral TAVR and SAVR. © 2017 Wiley Periodicals, Inc.

IMPACT OF COMPLICATION COST ASSUMPTIONS ON THE REAL-WORLD COST-EFFECTIVENESS OF TRANSCATHETER AORTIC VALVE REPLACEMENT IN THE UNITED STATES

Invited Commentary

In patients with severe symptomatic aortic stenosis at low surgical risk, transfemoral transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve has been shown to reduce the composite of death, stroke, or rehospitalization at 2-year follow-up compared with surgical aortic valve replacement (SAVR). Whether TAVR is cost-effective compared with SAVR for low-risk patients remains uncertain. Between 2016 and 2017, 1000 low-risk patients with aortic stenosis were randomly assigned to TAVR with the SAPIEN 3 valve or SAVR in the PARTNER 3 trial (Placement of Aortic Transcatheter Valves). Of these patients, 929 underwent valve replacement, were enrolled in the United States, and were included in the economic substudy. Procedural costs were estimated using measured resource use. Other costs were determined by linkage with Medicare claims or by regression models when linkage was not feasible. Health utilities were estimated using the EuroQOL 5-item questionnaire. With the use of a Markov model informed by in-trial data, lifetime cost-effectiveness from the perspective of the US health care system was estimated in terms of cost per quality-adjusted life-year gained. Although procedural costs were nearly $19 000 higher with TAVR, total index hospitalization costs were only $591 more with TAVR compared with SAVR. Follow-up costs were lower with TAVR such that TAVR led to 2-year cost savings of $2030/patient compared with SAVR (95% CI, -$6222 to $1816) and a gain of 0.05 quality-adjusted life-years (95% CI, -0.003 to 0.102). In our base-case analysis, TAVR was projected to be an economically dominant strategy with a 95% probability that the incremental cost-effectiveness ratio for TAVR would be <$50 000/quality-adjusted life-year gained (consistent with high economic value from a US health care perspective). These findings were sensitive to differences in long-term survival, however, such that a modest long-term survival advantage with SAVR would render SAVR cost-effective (although not cost saving) compared with TAVR. For patients with severe aortic stenosis and low surgical risk similar to those enrolled in the PARTNER 3 trial, transfemoral TAVR with the SAPIEN 3 valve is cost saving compared with SAVR at 2 years and is projected to be economically attractive in the long run as long as there are no substantial differences in late death between the 2 strategies. Long-term follow-up will be critical to ultimately determine the preferred treatment strategy for low-risk patients from both a clinical and economic perspective.

Senile calcific aortic stenosis (AS) is the most common acquired valvular heart disease with an increasing prevalence attributable to an aging population. Survival is poor in patients with severe or critical AS, chiefly after the onset of symptomology that primarily includes angina, dyspnea, or syncope. On the onset of symptoms, mortality occurs at very high rates during the ensuing 2 to 3 years.1 Until recently, surgical aortic valve replacement represented the sole therapy that definitive reduced mortality and morbidity in patients with severe symptomatic AS, with medical therapy generally ineffective of these patients. Given the advanced age commonly associated with severe AS, a high proportion of these patients are denied surgical intervention because of multiple comorbidities and excessively high surgical risk.2 Recently, transcatheter aortic valve replacement (TAVR) has emerged as a novel disruptive technology that serves an alternative therapy to surgical AVR and has been shown to be an effective therapy in nonoperable and high-risk patients with severe symptomatic AS.3,4 TAVR was first described in humans by Cribier et al in 20025 by a transvenous approach delivered in an antegrade fashion. This technique requires a transseptal puncture and passage of the aortic stent valve across the mitral valve to the aortic position. Subsequently, array of alternative transvascular approaches have arisen, including transfemoral, transaortic, trans-subclavian, and aortic methods. Of these, the retrograde transarterial approach through the femoral artery, developed by Webb et al,6 has been the commonly used approach, with >60 000 such procedures performed worldwide to date. To date, the global experience with TAVR as documented in both single and multicenter registries as well as through multicenter trials have shown good clinical outcomes with improvement in hemodynamic and clinical status, establishing TAVR to be a feasible alternative therapy to traditional surgical aortic valve …

Randomised trials comparing transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) have included mainly elderly patients >80 years. The authors investigated comparative in-hospital outcomes of younger patients <75 years undergoing transfemoral (TF) TAVR or isolated SAVR. A total of 6,972 patients aged 65-74 years undergoing TF-TAVR or SAVR between 2013 and 2014 were identified from the observational German Quality Assurance Registry on Aortic Valve Replacement (AQUA), which comprises all TAVR and SAVR procedures performed in Germany. Analyses were performed for the overall unmatched cohort as well as for 1,388 propensity-matched patients. Overall, 82.4% of patients <75 years needing treatment for aortic valve stenosis received SAVR. Patients undergoing TF-TAVR were older and had more comorbidities with higher predicted risk of death. After propensity-matching, in-hospital mortality (1.3% vs. 1.9%, p=0.39), neurologic complications (1.0% vs. 2.1%, p=0.09), and myocardial infarctions (0 vs. 0.3%, p=0.16) were not different after TF-TAVR or SAVR. Postoperative delirium was more frequent after SAVR (8.9% vs. 2.4%, p<0.001), whereas the need for new pacemaker was 4 times higher after TF-TAVR (13.3% vs. 3.5%, p<0.001). Younger patients <75 years undergoing TF-TAVR or SAVR had similar outcomes with the exception of more frequent need for new pacemaker implantation and less frequent incidence of post-operative dialysis and delirium in TF-TAVR patients. Whether these similar in-hospital outcomes are replicable in the longer-term events in TF-TAVR and SAVR remains to be proven in future studies.