New York Valves 2024: Everything you need to know in a nutshell

The NOTION-2 trial provides important insights into the comparison between TAVR and SAVR in a young, low-risk patient population, including those with bicuspid AS. The analysis included 81 patients undergone to TAVR and 77 to surgery with less than 70 years old.

Key message:

The NOTION-2 trial demonstrates clinical equipoise between TAVR and SAVR in very young patients (70 years old or younger) with tricuspid aortic stenosis at one year, while outcomes are less favorable for TAVR in young bicuspid AS patients.

Outcome details at 1 year:

• Primary composite (death, stroke, re-hospitalization) endpoint (PE): TAVR = 8.6 % vs. SAVR = 5.2 %, HR 1.76 (95 % CI 0.5-5.8), p = 0.4
• All-cause mortality at one year: TAVR = 2.5 % vs. SAVR = 1.3 %, p = 0.6
• Stroke at one year: TAVR = 1.9 % vs. SAVR = 2.8 %, p = 0.4
• Myocardial infarction at one year: TAVR = 3.7 % vs. SAVR = 2.6 %, p = 0.7
• Tricuspid AS Patients PE: TAVR = 5.8 % vs. SAVR = 7.8 %, HR 0.7 (95 % CI 0.2-3.2), p = 0.7
• Bicuspid AS Patients PE: TAVR = 13.8 % vs. SAVR = 0.0 %, p < 0.05

The SMART trial provides critical insights into the predictors of clinical outcomes and valve performance in patients with small aortic annuli undergoing TAVR (716 patients randomized 1:1 stratified by site & sex: SEV (n = 355) Medtronic Evolut PRO/PRO+/FX vs BEV (N = 361) Edwards SAPIEN 3/SAPIEN 3 Ultra).

Key message:

At 12 months, the SMART trial showed that self-expanding valves (SEVs) had superior valve performance and non-inferior clinical outcomes compared with balloon-expandable valves (BEVs), with significant predictors of adverse outcomes, including history of arrhythmia, NYHA Class III/IV, chronic lung disease, and lower stroke volume index.

Outcome details:

• All-cause mortality: SEV 5.1 % vs. BEV 5.9 %, HR 0.88 (95 % CI 0.47, 1.65)
• Disabling stroke: SEV 3.1 % vs. BEV 2.6 %, HR 1.26 (95 % CI 0.52, 3.03)
• Heart failure rehospitalization: SEV 3.8 % vs. BEV 3.5 %, HR 1.11 (95 % CI 0.51, 2.44)
• Bioprosthetic valve dysfunction: SEV 9.4 % vs. BEV 41.6 %, p < 0.001
• Predictors of clinical outcomes:
  • History of arrhythmia: HR 3.14 (95 % CI 1.83-5.39), p < 0.001
  • NYHA Class III/IV vs. I/II: HR 2.02 (95 % CI 1.17-3.49), p = 0.01
  • Chronic lung disease: HR 1.93 (95 % CI 1.07-3.47), p = 0.03
  • Stroke volume index (per ml/beat/m²): HR 0.96 (95 % CI 0.93-0.99), p = 0.003
• Predictors of BVD:
  • Balloon-expandable valve: OR 8.21 (95 % CI 5.10-13.23), p < 0.0001
  • Body surface area (per 0.1 m²): OR 1.27 (95 % CI 1.13-1.43), p < 0.0001
  • Aortic annulus area (per 1 mm²): OR 0.99 (95 % CI 0.98-0.99), p < 0.0001

The study provides important insights into the impact of cerebral embolic protection devices (EPDs) on disabling stroke following TAVR.

Key message:

The TVT Registry analysis shows a small but significant reduction in disabling in-hospital stroke with cerebral EPD use during TAVR, particularly benefiting patients with prior stroke. The reduction aligns with findings from the PROTECTED-TAVR trial, though the effect size may be modest.

Outcome details:

• In-Hospital Disabling Stroke:
  • IV Analysis: EPD: 0.79 % vs. No EPD: 0.91 %, Adjusted RR 0.87 (95 % CI 0.73-1.00)
  • Propensity-Weighted Analysis: EPD: 0.76 % vs. No EPD: 0.95 %, Adjusted RR 0.79 (95 % CI 0.70-0.90)
• Any stroke:
  • IV Analysis: EPD: 1.27 % vs. No EPD: 1.40 %, Adjusted RR 0.90 (95 % CI 0.79-1.01)
  • Propensity-Weighted Analysis: EPD: 1.24 % vs. No EPD: 1.47 %, Adjusted RR 0.84 (95 % CI 0.76-0.93)
• Non-disabling stroke:
  • IV Analysis: EPD: 0.48 % vs. No EPD: 0.49 %, Adjusted RR 0.97 (95 % CI 0.78-1.16)
  • Propensity-Weighted Analysis: EPD: 0.48 % vs. No EPD: 0.52 %, Adjusted RR 0.92 (95 % CI 0.79-1.08)
• GI or GU bleed:
  • IV Analysis: EPD: 0.38 % vs. No EPD: 0.37 %, Adjusted RR 1.04 (95 % CI 0.82-1.26)
  • Propensity-Weighted Analysis: EPD: 0.39 % vs. No EPD: 0.38 %, Adjusted RR 1.05 (95 % CI 0.86-1.27)

The study provides critical insights into the long-term outcomes of TAVR with BEVs in patients with small aortic annuli, highlighting the excellent durability and comparable clinical outcomes with larger annuli.

Key message:

Five-year outcomes from the PARTNER trials (PARTNER 2 S3i registry, n = 870, or PARTNER 3 RCT, n = 485; total 1,355 patients who received SAPIEN 3 TF TAVR) demonstrate comparable clinical outcomes and valve durability between small and large annulus patients receiving SAPIEN 3 BEV, with no significant impact of post-TAVR mean gradient or 30-day prosthesis-patient mismatch on long-term outcomes.

Outcome details:

• Primary endpoint (all-cause death, disabling stroke, or HFH at 5 years): HR 0.9 (95 % CI 0.5-1.7), p = 0.68
• All-Cause death at 5 years: Small Annulus = 28.5 % vs. Large Annulus = 29.3 %, HR 0.9 (95% CI 0.5-1.8), p = 0.76
• Aortic valve reintervention at 5 years: Small Annulus = 1.8 % vs. Large Annulus = 2.7%, p = 0.52
• Bioprosthetic valve failure at 5 years: Small Annulus: 2.9% vs. Large Annulus: 2.1%, p=0.46
• Primary endpoint (Small Annulus, MG < 20 vs. ≥ 20 mmHg): < 20 mmHg = 33.9 % vs. ≥ 20 mmHg = 44.2 %, p = 0.32
• All-Cause dDeath (Small Annulus, MG < 20 vs. ≥ 20 mmHg): < 20 mmHg = 27.6 % vs. ≥ 20 mmHg =  30.8%, p = 0.88
• Primary endpoint (Small Annulus, No PPM vs. Moderate PPM vs. Severe PPM): No PPM = 35.5 % vs. Moderate PPM = 44.1 % vs. Severe PPM = 30.4%, p = 0.22

The study provides critical insights into the long-term outcomes of self-expanding TAVI compared with surgery in patients at intermediate or higher surgical risk. Implanted study population (N = 5,752) = CoreValve high risk & SURTAVI RCT implanted subjects (N = 2,401) + CoreValve extreme risk & CAS non-RCT implanted subjects (N = 3,351).

Key message:

The findings demonstrate significantly better 5-year valve performance and lower risk of bioprosthetic valve dysfunction (BVD) in patients undergoing CoreValve/Evolut TAVI compared with surgery, with BVD associated with increased mortality and hospitalization.

Outcome details:

• BVD: Surgery = 15.4 % vs. TAVI = 9.6 %, sHR 0.57 (95 % CI 0.44-0.73), p < 0.001
• SVD: Surgery = 4.5 % vs. TAVI = 2.1 %, sHR 0.50 (95 % CI 0.30-0.82), p = 0.007
• NSVD: Surgery = 9.6 % vs. TAVI = 5.5 %, sHR 0.55 (95 % CI 0.40-0.75), p < 0.001
• Severe PPM: Surgery = 12.1 % vs. TAVI = 3.7 %, sHR 0.28 (95 % CI 0.19-0.41), p < 0.001
• Severe PVR: Surgery = 0.31 % vs. TAVI = 2.3 %, sHR 7.86 (95 % CI 2.38-25.89), p < 0.001
• All-Cause Mortality: BVD = adj-HR 1.53 (95 % CI 1.35-1.72), p < 0.001
• Cardiovascular Mortality: BVD = adj-HR 1.76 (95 % CI 1.52-2.04), p < 0.001

The study provides important insights into the mid-term outcomes of AViV using balloon-expandable valves, highlighting the need for careful consideration of valve type and patient characteristics to optimize treatment outcomes.

Key message:

At mid-term follow-up, AViV (N = 13 711) using balloon-expandable valves showed lower mortality and stroke rates than native TAVR (N = 368 176), with significant differences in hemodynamic performance and re-intervention rates depending on valve type and patient characteristics.

Outcome details:

• All-cause mortality at 3 years: AViV 26.9 %, native TAVR 35.3 %, HR 0.72 (95 % CI 0.67, 0.77), p < 0.001
• Stroke at 3 years: AViV 8.1 %, native TAVR 9.2 %, HR 0.83 (95 % CI 0.73, 0.94), p = 0.003
• Re-intervention rate at 3 years: AViV 3.3 %, native TAVR 1.3 %, HR 2.36 (95 % CI 1.86, 2.99), p < 0.001
• PSM: Sapien 3 Ultra Resilia vs. Sapien 3/Sapien 3 Ultra: Larger EOA (1.7 vs. 1.5 cm²), lower mean gradient (14.2 vs. 17.4 mmHg), p < 0.0001
• Stented vs. Stentless: Larger mean EOA (1.6 vs. 1.4 cm²), lower mean gradient (15.8 vs. 18.0 mmHg), p < 0.0001

The study presents promising 30-day results for the novel TRIA polymer surgical mitral valve, indicating its potential as a viable alternative for patients with symptomatic, moderate to severe mitral valve stenosis and/or regurgitation.

Key message:

At 30 days, the TRIA surgical mitral valve showed low mortality and thromboembolism rates, with excellent hemodynamic performance, indicating its potential as an effective treatment for patients with symptomatic, moderate to severe mitral valve stenosis and/or regurgitation.

Outcome details:

• All-cause mortality: 1.4 % (1 patient)
• Thromboembolism: 1.4 % (1 patient)
• Major bleeding: 1.4 % (1 patient)
• Mean gradient: reduced from 9.5 mmHg to 4.3 mmHg
• Peak gradient: reduced from 19.8 mmHg to 9.6 mmHg
• EOA: increased from 0.9 cm² to 1.7 cm²

The study provides critical insights into the use of the MitraClip System for the management of moderate secondary mitral regurgitation (SMR) in heart failure patients, based on one of the largest and most recent studies about mitral transcatheter edge-to-edge repair (TEER).

Key message:

EXPANDed studies demonstrate substantial 1-year clinical benefits in moderate SMR patients treated with the MitraClip TEER therapy, including sustained MR reduction, significant LV volume reduction, and large improvements in quality of life.

Outcome details:

• All-Cause Mortality: 15.2 % (2+ SMR) vs. 16.0 % (≥3+ SMR), p = 0.68
• Heart Failure Hospitalization: 21.9 % (2+ SMR) vs. 23.7 % (≥3+ SMR), p = 0.38
• MR Reduction to ≤ 1+ at 1 Year: 94.6 % (2+ SMR) vs. 89.6 % (≥ 3+ SMR), p < 0.0001
• LVEDV Reduction: -20 ± 4 mL (2+ SMR), p < 0.0001
• LVESV Reduction: -24 ± 4 mL (2+ SMR), p < 0.0001
• NYHA I/II Improvement: 79.2 % (2+ SMR) vs. 77.8 % (≥ 3+ SMR), p < 0.0001
• KCCQ-OS Score Increase: +21 ± 2 points for both groups, p < 0.0001

The study provides critical insights into the comparative effectiveness of TEER and TMVR in patients with challenging mitral valve anatomy.

Key message:

TMVR demonstrated superior outcomes in terms of severe mitral regurgitation (MR) reduction, with similar functional improvement but higher all-cause mortality and post-procedural complications at 2 years compared to TEER.

Outcome details:

• Residual MR ≥ 2 at 2 years: TEER 39.0 % vs. TMVR 45.0 %, p = 0.02
• Similar functional improvement: p = 0.58 for NYHA I-II at 2 yrs. TEER 68.9 % vs. TMVR 70.5 %
• EROA: TEER 0.3 cm² (median) vs. TMVR 0.4 cm² (median), p = 0.012
• Regurgitant volume: TEER 45.0 mL (median) vs. TMVR 61.6 mL (median), p = 0.046
• Mean MV pressure gradient: TEER 3.0 mmHg (median) vs. TMVR 3.9 mmHg (median), p < 0.001
• Higher post-procedural complications for TMVR: major access site bleeding p = 0.002; major bleeding 0.031; AKI stage 2/3 p < 0.001; disabling stroke p = 0.24 (3.6 % vs 0.8 %)
• All-cause mortality at 2 years: TEER 32.1 % vs. TMVR 45.0 %, p = 0.03
• NYHA Class III/IV: TEER 39.0 % vs. TMVR 32.1 %, p = 0.04

The study provides important insights into the incidence, predictors, and management of conduction disturbances following TTVR.

Key Message:

The TRIPLACE Registry included 182 patients treated for severe TR with TTVR, 50 patients (27 %) with already a PPM, and 3 patients (1.6 %) undergone surgery. The analysis (129 patients) shows at 1 month: 22 % of new RBBB, a 15 % incidence of high-grade AVB (HAVB), and a 12.4 % rate of new PPM implantation at 1-month post-TTVR. Baseline conduction abnormalities significantly increase the risk of HAVB, emphasizing the need for careful pre-procedural assessment and post-procedural monitoring.

Outcome details:

• HAVB at 1 month: 15 %
• New PPM implantation: 12.4 %
• Procedural complete AVB: 3.9 % (HAVB 21.1 %, No HAVB 0.9 %, p = 0.002)
• Baseline LBBB or LAFB/LPFB → HAVB 21 % vs. No HAVB 5 %, p = 0.034; Adj-OR: 6.9 (95 % CI 1.2-36.4)
• Management of conduction disturbances: Leadless PM 37.5 %, Dual Chamber PM 25.0 %, Coronary Sinus Lead 37.5 %

The study provides critical insights into the use of the TriClip G4 system for the management of severe TR across a wide range of anatomies, highlighting significant benefits in terms of reducing TR severity and improving patient outcomes.

Key message:

The TRILUMINATE Pivotal trial demonstrates that the TriClip G4 system effectively reduces tricuspid regurgitation and improves symptoms and quality of life in patients with severe TR maintaining a high safety profile. 57 % (179) of patients had more than 4 valve leaflets, 43 % (103) had a gaps ≥ 7 mm, and 29 % (93) of patients had prior RV lead. 

Outcome details:

• Patients with more than 3 leaflets:
  • TR Reduction (to moderate or less): 83 %
  • TR Reduction (to mild or less): 45 %
  • NYHA Functional Class I/II: 81 %
  • Change in KCCQ Score: +18 ± 20 points (p < 0.0001)
• Patients with coaptation gaps ≥ 7 mm:
  • TR Reduction (to moderate or less): 78 %
  • TR Reduction (to mild or less): 36 %
  • NYHA Functional Class I/II: 82 %
  • Change in KCCQ Score: +20 ± 22 points (p < 0.0001)
• Patients with prior RV lead placement:
  • TR Reduction (to moderate or less): 87 %
  • TR Reduction (to mild or less): 44 %
  • NYHA Functional Class I/II: 84 %
  • Change in KCCQ Score: +21 ± 22 points (p < 0.0001)

The study provides important insights into the impact of TR reduction on right heart remodeling in patients undergoing TEER with the TriClip system. The findings highlight the significant benefits of TR reduction on right heart structure and function.

Key Message:

93 subjects from 10 sites were enrolled in the imaging sub-study between July 2020 and March 2024. The TRILUMINATE Pivotal imaging sub-study demonstrates significant right heart reverse remodeling and improvement in effective RVEF following TR reduction with TriClip treatment. The extent of remodeling is associated with the degree of TR reduction.

Outcome details:

Large reduction in TR: ≥ 30 mL reduction in regurgitant volume
Moderate reduction in TR: ≥ 15 mL but < 30 mL reduction in regurgitant volume
Small reduction in TR: < 15 mL reduction or increase in regurgitant volume
TR Volume Change (Baseline vs 30 days): significant reduction in the TriClip group.

• RVEDV Change (Baseline vs 30 days):
  • Large Reduction in TR: -55 ml
  • Moderate Reduction in TR: -18 ml
  • Small or No Reduction in TR: 5 mL
• RVESV Change (Baseline vs 30 days):
  • Large Reduction in TR: -5 ml
  • Moderate Reduction in TR: 0 ml
  • Small or No Reduction in TR: 2 mL

Effective RVEF Change (Baseline vs 30 days): significant improvement with large TR reduction.

• RA Volume Change (Baseline vs 30 days):
  • Large Reduction in TR: -28 ml
  • Moderate Reduction in TR: -20 ml
  • Small or No Reduction in TR: 7 mL
• TV Annulus Area Change (Baseline vs 30 days):
  • Large Reduction in TR: -2.6 cm²
  • Moderate Reduction in TR: -2.1 cm²
  • Small or No Reduction in TR: -0.5 cm²