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Valve related trials in 2024

Valve related trials in 2024

By Dr Ben Chisnall

Journal of the American College of Cardiology

Lurz, P, Rommel, K, Schmitz, T. et al. Real-World 1-Year Results of Tricuspid Edge-to-Edge Repair From the bRIGHT Study. JACC. 2024 Aug, 84 (7) 607–616.

https://doi.org/10.1016/j.jacc.2024.05.006

This study looked at 511 patients treated with the Abbott TriClipDevice in 26 sites across Europe from 2020 – 2022 (mean age 79.7; 88% massive or torrential TR).

TR was reduced to moderate or less in 81% at 1 year, with improvements in NYHA functional class (21% to 75% I/II, P < 0.0001) and KCCQ score (19 ± 26-points, P <0.0001).

One-year mortality was significantly lower in subjects who achieved moderate or lower TR at 30 days, with no difference in class of TR lower than moderate.

Baseline serum creatinine and baseline RV TAPSE were independently associated with mortality at 1 year (OR: 2.169; 95% CI: 1.494-3.147; P < 0.0001; OR: 0.636; 95% CI: 0.415-0.974; P = 0.0375).

Authors’ conclusions: Tricuspid TEER using the TriClip system was safe and effective through 1 year for subjects with significant TR and advanced disease in a diverse real-world population.

The New England Journal of Medicine

Hermann H et al. Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus. N Engl J Med 2024;390:1959-1971 (SMART trial)

https://doi.org/10.1056/NEJMoa2312573

716 patients with symptomatic severe AS and an aortic-valve annulus area of 430 mm2 or less were randomised 1:1 to undergo TAVR with either a self-expanding supra-annular valve (SEV) or a balloon expandable valve (BEV) (83 sites, 13 countries; 87% women; mean age 80)

Primary end points: a composite of death, disabling stroke, or rehospitalization for heart failure, and acomposite end point measuring bioprosthetic-valve dysfunction in 12 months

Kaplan-Meier estimate for death / stroke / heart failure was 9.4% for SEV and 10.6% with BEV (difference -1.2%; CI -4.9 to 2.5; p = 0.001 for noninferiority)

Kaplan-Meier estimate for valve dysfunction was 9.4% with SEV and 41.6% with BEV (difference -32.2%; CI-38.7 to -25.6 to p <0.001 for superiority)

Authors’ conclusions: Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supra-annular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months

European Heart Journal

Troels Højsgaard Jørgensen TJ et al. Transcatheter aortic valve implantation in low-risk tricuspid or bicuspid aortic stenosis: the NOTION-2 trial, European Heart Journal, Volume 45, Issue 37, 1 October 2024, Pages 3804–3814,

https://doi.org/10.1093/eurheartj/ehae331

  • Low-risk patients (n=370) aged ≤75 years with severe symptomatic AS were randomised 1:1 to TAVI or surgery.
  • Primary endpoint: a composite of all-cause mortality, stroke, or rehospitalization at 12 months.
  • 1-year incidence of the primary endpoint was 10.2% in the TAVI group and 7.1% in the surgery group [absolute risk difference 3.1%; 95% CI, −2.7% to 8.8%; hazard ratio (HR) 1.4; 95% CI, 0.7–2.9; P = 0.3].
  • TAVI patients had lower risk of major bleeding and new-onset AF; but higher risk of non-disabling stroke, PPM implantation, and moderate or greater paravalvular regurgitation.
    The risk of the primary composite endpoint was 8.7% and 8.3% in patients with tricuspid AS (HR 1.0; 95% CI, 0.5–2.3) and 14.3% and 3.9% in patients with bicuspid AS (HR 3.8; 95% CI, 0.8–18.5) treated with TAVI or surgery, respectively (P for interaction = 0.1).
  • Authors’ conclusions: Among low-risk patients aged ≤75 years with severe symptomatic AS, the rate of the composite of death, stroke, or rehospitalization at 1 year was similar between TAVI and surgery. Transcatheter aortic valve implantation outcomes in young bicuspid AS patients warrant caution and should be further investigated.

European Heart Journal

Mascherbauer J et al. Sex-related differences in severe native valvular heart disease: the ESC-EORP Valvular Heart Disease II survey, European Heart Journal, Volume 45, Issue 37, 1 October 2024, Pages 3818–3833

https://doi.org/10.1093/eurheartj/ehae523

  • This study looked at sex differences in patients with severe native valvular heart disease included in the VHD II EURObservational Research Programme.
  • 5219 patients were enrolled in 208 European and North African centres and followed for 6 months [41.2% AS, 5.3% AR, 4.5% MS, 21.3% MR, 2.7% isolated right-sided VHD, 24.9% multiple left-sided VHD].
  • Overall, women were older, more symptomatic, and presented with a higher EuroSCORE II. Bicuspid aortic valve and AR were more prevalent among men while mitral disease, concomitant TR, and AS above age 65 were more prevalent among women.
  • Concordance with recommended treatment was poorer in women with MS and primary MR (both P < .001), with age, patient refusal, and decline of symptoms after conservative treatment were reported as reasons.
  • Concomitant tricuspid intervention was performed at a similar rate in both sexes although prevalence of significant TR was significantly higher in women. In-hospital and 6-month survival did not differ between sexes.
  • Authors’ conclusions: (i) Valvular heart disease subtype varied between sexes; (ii) concordance with recommended intervention for MS and primary MR was significantly lower for women; and (iii) survival of men and women was similar at 6 months.

Heart

Galli E, Le Ven F, Coisne A, et al. Randomised study for the Optimal Treatment of symptomaticpatients with low-gradient severe Aortic valve Stenosis and preserved left ventricular ejectionfraction (ROTAS trial) Heart 2024;110:1223-1230.

https://doi.org/10.1136/heartjnl-2024-324224

  • Patients with symptomatic LG severe AS and preserved LVEF (>50%) were randomised 1:1 to AVR or medical therapy (MT). The primary endpoint was a composite of overall death and/or cardiovascular hospitalisation.
  • The study was stopped early because of insufficient recruitment.
  • 52 patients (age 79±7 years; women 54%; NYHA III-IV 27%; median STS score 3.3%) were included in the study. During follow-up (mean: 14±7 months), the primary endpoint occurred in 12 (23%) patients.
  • Compared with MT, AVR was not associated with a significant prognostic benefit (events: 5/26 (19%) vs 7/26 (27%) (HR 0.76, 95% CI 0.24 to 2.39, p=0.63). During follow-up, 11 (42%) patients in the MT group developed class I criteria for AVR or severe symptoms justifying a cross-over to the AVR group.
  • Authors’ conclusions: Because of the small number of included patients and short follow-up the ROTAS trial was underpowered and unable to demonstrate a difference in the study endpoint between treatment arms. In patients in the MT arm, a regular echocardiographic and clinical assessment might be useful to disclose those developing class I indications of AVR or severe AS-related symptoms.

Journal of the American Heart Association

Rogers CA et al. Low Frequency Ventilation During Cardiopulmonary Bypass to Protect Postoperative Lung Function in Cardiac Valvular Surgery: The PROTECTION Phase II Randomized Trial. J Am Heart Assoc. 2024 Oct;13(19):e035011.

https://doi.org/10.1161/JAHA.124.035011

  • 63 patients with severe mitral or aortic valve disease were randomized to either LFV (n=33) or usual care (n=30).
  • Primary outcomes included release of generic inflammatory and vascular biomarkers and the lung-specific biomarker sRAGE (soluble receptor for advance glycation end products) up to 24 hours post-surgery.
  • Secondary outcomes included pulmonary function tests and 6-minute walking test up to 8 weeks post discharge.
  • LFV was associated with changes of sRAGE levels after CPB. No changes were observed for any of the generic biomarkers.
  • Respiratory index soon after surgery, FEV1/FVC ratio 6 weeks post-op, and FVC and 6-minute walking test score at discharge were better preserved in the LFV group. No other differences were noted.
  • Authors’ Conclusions: The use of LFV during CPB in patients undergoing valvular surgery was feasible and safe and was associated with changes in sRAGE levels along with better preserved lung function and walking performance. These observations warrant further investigation in larger future studies.

The Journal of Thoracic and Cardiovascular Surgery

Yousef, Sarah et al. Valve-in-valve transcatheter aortic valve replacement versus isolated redo surgical aortic valve replacement. The Journal of Thoracic and Cardiovascular Surgery, Volume 168, Issue 4, 1003 – 1010

https://doi.org/10.1016/j.jtcvs.2023.06.014

  • Retrospective study comparing valve in valve (ViV) TAVR (n = 198) with redo isolated SAVR (n = 147).
  • Operative mortality was 2% in each group; observed to expected operative mortality in the redo SAVR group was higher than in the ViV TAVR group (1.2 vs 0.32).
  • The redo SAVR group more likely to have transfusions / need for reoperation; new-onset renal failure requiring dialysis; and need for PPM postop.
  • Mean gradient was lower in the redo SAVR group than in the ViV group at 1 year.
  • ViV TAVR was not significantly associated with an increased hazard of death compared with redo SAVR (hazard ratio, 1.39; 95% CI, 0.65-2.99; P = .40). Estimates for heart-failure readmissions were higher in the ViV cohort.
  • Authors’ conclusions: ViV TAVR and redo SAVR were associated with comparable mortality. Patients who underwent redo SAVR had lower postoperative mean gradients and greater freedom from heart failure readmissions, but they also had more postoperative complications than the VIV group, despite their lower baseline risk profiles.