Report of the STS-ACC TVT TAVR Registry

Carroll JD, Mack MJ, Vemulapalli S, et al.
STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. J Am Coll Cardiol 2020;76:2492-2516.

The following are key points to remember from this report of the Society of Thoracic Surgeons–American College of Cardiology Transcatheter Valve Therapy (STS-ACC TVT) Registry:

  1. From 2011-2019, data for 276,316 patients who have undergone commercial transcatheter aortic valve replacement (TAVR) have been submitted to the STS-ACC TVT Registry. This includes demographics, patient characteristics, procedure information, 30-day and 1-year mortality, in-hospital and 30-day morbidity, hospital length of stay, and discharge disposition. This report of the STS-TVT Registry presents procedural outcomes for each year of data collected from 2011-2019, as well as trends over time.
  2. Case Volume and Geographical Reach: TAVR volume has increased annually, from 13,723 cases in the early experience (2011-2013) to 72,991 cases in 2019. TAVR volume eclipsed isolated surgical aortic valve replacement (SAVR) volume between 2015-2016 and then eclipsed all SAVR volume (isolated SAVR as well as SAVR/coronary artery bypass grafting [CABG] and composite root replacement) between 2018-2019. The geographic penetrance of TAVR sites includes all 50 states as well as the District of Columbia and Puerto Rico, and by the end of August 2020, the number of US sites performing TAVR was at 715. There is wide variation in procedure volume per site (median volume per site is 84 cases; interquartile range [IQR], 50-137), with 161 sites performing <50 annual cases in 2019.
  3. Patient Characteristics: In 2019, the median age of patients who underwent TAVR was 80 years (IQR, 73-85 years), with median age 75 years (IQR, 70-81 years) in the low-risk group; 55.8% of patients were male. Median 30-day STS Predicted Risk of Mortality (STS-PROM) has steadily decreased from 6.9% in 2013 to 4.4% in 2019, but by Heart Team evaluation, 31,000-33,000 procedures per year were performed in high- or extreme-risk patients over the last several years. New York Heart Association (NYHA) class of treated patients has decreased over time. While the number of TAVR procedures performed in Black patients has increased over time, the proportion of TAVR procedures performed in Black patients was only 4.0% in 2019.
  4. Procedure Characteristics: Over 90% of procedures were performed for native severe aortic stenosis (AS). Other indications include failed bioprosthetic valve (4.3%), mixed AS/aortic insufficiency (AI), and primary AI (0.7%). Procedures were predominantly elective (91.4%), and the majority were performed in a hybrid operating room (54.7%). Major shifts that have occurred include the shift toward use of conscious sedation (in 64% of TAVRs performed in 2019) over general anesthesia and treating most (95%) patients via transfemoral access, both of which have decreased complication rates and length of stay as well as increasing discharge to home. Cardiopulmonary bypass is now used rarely (0.4%) and conversion to open surgery has decreased over time from 1.4% to 0.4%. Use of adjunctive techniques, including placement of cerebral protection devices (n = 11,877), balloon fracture of a bioprosthetic valve stent frame (n = 332), and bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) (n = 166) has been captured since 2018.
  5. TAVR Valve Choice: In 2019, 72.3% of native TAVR valves implanted were balloon-expanding, 26.7% were self-expanding, and 1.0% were mechanically expanding. For valve-in-valve (ViV) TAVR procedures, 53.3% were self-expanding, 46.5% were balloon-expanding, and 0.2% were mechanically expanding.
  6. Outcomes: Mortality has declined annually and was down to 1.3% (in-hospital) and 2.5% (30-day) in 2019. Based on 2018 data, overall 1-year mortality decreased to 12.6%, with mortality differing based on risk group and intermediate-risk patients experiencing in-hospital, 30-day, and 1-year mortality about half that of high/extreme-risk patients. Overall in-hospital and 30-day stroke decreased to 1.6% and 2.3%, respectively, by 2019. Need for in-hospital dialysis declined to 0.4%, use of blood transfusion decreased to 5.8%, and major vascular access site complications decreased to 1.3%. Incidence of permanent pacemaker implantation at 30 days has been stable over time at 10.8%. Length of stay has declined from a median of 7 days (IQR, 4-10 days) to 2 days (IQR, 1-3 days), with median length of stay similar across risk groups. The majority of patients (90.3%) are discharged home.
  7. TAVR Valve Function: Degree of intra-/para-valvular AI after TAVR has markedly improved over time. Incidence of moderate/severe AI at 30 days was seen in 8% of patients in the early TAVR experience but decreased to 1.6% in 2019. However, mean transvalvular gradient ≥20 mm Hg after TAVR, either in-hospital or at 30 days, has increased from 5.3% before 2013 to 6.2% in 2018. Notably, the proportion of patients with gradient ≥20 mm Hg was highest in the low-risk group, at 8.2%. At 1 year, 4.7% of patients treated in 2018 had an increase in transvalvular mean gradient of ≥10 mm Hg, which occurred similarly across risk groups.
  8. Valve-in-valve TAVR: Valve-in-valve (ViV) TAVR procedures involving immediate deployment of a second valve during the primary procedure due to malfunction of the first TAVR valve has declined. Elective (ViV) TAVR has increased and comprised 6.2% of procedures in 2019 (n = 4,508), predominantly as TAVR-in-SAVR.
  9. Low-Risk Patients: Since Food and Drug Administration approval of TAVR in patients considered low risk for mortality from SAVR, the number of commercial TAVR procedures performed in this cohort was up to 8,395, with median age 75 years (IQR, 70-81 years), 65% being male, 48.9% with NYHA class III or IV, median STS-PROM 2.3% (IQR, 1.6-3.5%), and 97.8% undergoing TAVR with transfemoral access. In-hospital mortality was 0.5%.

Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease

Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Cardiac Surgical Procedures, Cardiopulmonary Bypass, Conscious Sedation, Coronary Artery Bypass, Geriatrics, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Length of Stay, Pacemaker, Artificial, Renal Dialysis, Risk Factors, Stents, STS/ACC TVT Registry, Transcatheter Aortic Valve Replacement

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