compariSon of secOnd-generation seLf-expandable vs. balloon-expandable Valves and gEneral vs. local anaesthesia in Transcatheter Aortic Valve Implantation - SOLVE-TAVI

Contribution To Literature:

The SOLVE-TAVI trial showed that both the Edwards Sapien S3 valve and Medtronic CoreValve Evolut R have equivalent clinical outcomes at 30 days among patients undergoing TAVR. Also, in this patient population, conscious sedation is equivalent to general anesthesia.

Description:

The goal of the trial was to compare the safety and efficacy of the Edwards Sapien S3 valve vs. Medtronic’s CoreValve among patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis. Further, in a 2x2 factorial design, the trial also sought to compare conscious sedation vs. general anesthesia in this patient population.

Study Design

Using a 2x2 factorial design, patients undergoing TAVR were randomized in a 1:1 fashion to either: a) TAVR with the Edwards Sapien S3 valve (n = 219) or the Medtronic CoreValve Evolut R (n = 219), or b) conscious sedation with local anesthesia (n = 218) vs. general anesthesia (n = 220).

  • Total number of enrollees: 447
  • Duration of follow-up: 30 days, 1 year
  • Mean patient age: 81.6 years
  • Percentage female: 52%

Inclusion criteria:

  • Symptomatic severe aortic stenosis
  • Adequate transfemoral access
  • Age ≥75 years
  • High risk for conventional surgical AVR (Society of Thoracic Surgeons [STS] risk score ≥10%, EuroSCORE ≥20%, or other high-risk features)

Exclusion criteria:

  • Contraindication for a specific valve type
  • Cardiogenic shock or hemodynamic instability
  • History of or active endocarditis
  • Active infection requiring antibiotic treatment
  • Life expectancy <12 months
  • Active peptic ulcer or upper gastrointestinal bleeding <3 months
  • Hypersensitivity or contraindication to aspirin, heparin, or clopidogrel
  • Participation in another trial

Other salient features/characteristics:

  • Median STS risk score: 4.8
  • Frailty: 40%
  • Atrial fibrillation: 45%
  • Pacemaker: 11%
  • Left ventricular ejection fraction >55%: 57%

Principal Findings:

a) Edwards Sapien S3 vs. Evolut R: The primary endpoint, all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, permanent pacemaker implantation at 30 days, was 25.9% vs. 28.4%, p for equivalence = 0.04, p for superiority = 0.83.

  • Mortality: 2.3% vs. 3.2%, p for equivalence < 0.0001
  • Stroke: 4.7% vs. 0.5%, p for equivalence = 0.03
  • Moderate/severe paravalvular leak (PVL): 1.5% vs. 3.4%, p for equivalence = 0.0002
  • New pacemaker: 19.2% vs. 23.0%, p for equivalence = 0.06

Secondary outcomes for Sapien S3 vs. Evolut R:

  • Device success: 91.7% vs. 94.0%, p = 0.46
  • Contrast use: 90 vs. 110 cc, p < 0.001
  • Major vascular complication: 6.4% vs. 5.1%, p = 0.54
  • Mean gradient ≥20 mm Hg at 1 month: 3.3% vs. 2.0%, p = 0.09

One-year outcomes for Sapien S3 vs. Evolut R:

  • Composite endpoint: 40.4% vs. 41.9%, p = 0.76
  • All-cause mortality: 17% vs. 17.6%, p = 0.88
  • Cardiovascular mortality: 1.8% vs. 0.5%, p = 0.19
  • Stroke: 6.9% vs. 1%, p = 0.002
  • Mean gradient: 10 vs. 6 mm Hg, p < 0.001

b) Conscious sedation vs. general anesthesia: The primary endpoint, all-cause mortality, stroke, myocardial infarction (MI), infection requiring antibiotic treatment, acute kidney injury at 30 days, was 25.5% vs. 27.0%, p for equivalence = 0.02; p for superiority = 0.74.

  • Mortality: 2.3% vs. 2.8%, p = 0.77
  • Stroke: 2.8% vs. 2.4%, p > 0.99
  • MI: 0.5% vs. 0.5%, p > 0.99

Secondary outcomes for conscious sedation vs. general anesthesia:

  • Moderate to severe PVL: 1.9% vs. 1.4%, p = 0.72
  • Need for catecholamines: 97.3% vs. 62.8%, p < 0.001
  • Hospital stay: 9 vs. 9 days, p = 0.74
  • Intensive care unit stay: 47 vs. 51 hours, p = 0.59

One-year outcomes for conscious sedation vs. general anesthesia:

  • All-cause mortality: 15.2% vs. 19.4%, p = 0 .27
  • Cardiovascular mortality: 0.9% vs. 1.4%, p = 0.68
  • Stroke: 3.0% vs. 4.9%, p = 0.33

Interpretation:

The results of this trial indicate that both the Edwards Sapien S3 valve and Medtronic CoreValve Evolut R have equivalent clinical outcomes at 30 days among mostly intermediate- and high-risk patients undergoing TAVR (median STS risk score 4.8). Stroke rates were numerically higher with Edwards Sapien S3, while moderate to severe PVL was numerically higher with Evolut R. At 1 year, the stroke rate was significantly higher with Edwards Sapien 3; echo-based mean gradients were also higher. The trial also shows that conscious sedation is equivalent to general anesthesia for TAVR, with no differences in moderate to severe PVL, clinical outcomes, or length of stay, but with a lower need for inotropic agents. Similar results were observed on 1-year follow-up.

This is an important trial because it provides head-to-head comparison between the two commercially available contemporary TAVR valves. However, the trial is underpowered for most individual endpoints. Longer-term outcomes are also needed, as are hemodynamic comparisons between the two valves (for instance, patient-prosthesis mismatch, valve thrombosis, etc.).

References:

Presented by Dr. Hans-Josef Feistritzer at the Transcatheter Cardiovascular Therapeutics Virtual Meeting (TCT Connect), October 16, 2020.

Thiele H, Kurz T, Feistritzer HJ, et al. Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: the randomized SOLVE-TAVI trial. Eur Heart J 2020;41:1890-9.

Webb J, Wood D, Sathananthan J, Landes U. Editorial: Balloon-expandable or self-expandable transcatheter heart valves. Which are best? Eur Heart J 2020;41:1990-2.

Presented by Dr. Holger Thiele at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2018), San Diego, CA, September 23, 2018.

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Atrial Fibrillation/Supraventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and CHD and Pediatrics, Cardiac Surgery and VHD, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Interventions, Interventions and Structural Heart Disease

Keywords: Transcatheter Cardiovascular Therapeutics, Acute Kidney Injury, Atrial Fibrillation, Anesthesia, Aortic Valve Stenosis, Catecholamines, Conscious Sedation, Geriatrics, Heart Defects, Congenital, Heart Valve Diseases, Heart Valve Prosthesis, Myocardial Infarction, Pacemaker, Artificial, Stroke, Thrombosis, TCT18, TCT20, Transcatheter Aortic Valve Replacement


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