“sustainable”

Reductions In Mitral Regurgitation At One Year

One-year follow-up data from the Tendyne European experience registry, which were presented during a late-breaking clinical trial session at PCR London Valves, point towards “low” rates of allcause and cardiovascular mortality, investigators have reported, as well as noting that the transcatheter treatment exhibits a durable clinical benefit, with a sustained reduction in mitral regurgitation (MR).

Tendyne (Abbott) is the first and only commercially available transcatheter mitral valve replacement (TMVR), having received the CE mark in January 2020 for the management of patients with mitral regurgitation (MR) who are not suitable for mitral valve surgery or percutaneous edge-to-edge repair.

Michaela Hell (University Medical Centre Mainz, Mainz, Germany) presented the latest results from the European registry—known as TENDER—reporting data from 195 patients across 31 sites throughout Europe to have implanted the device commercially between January 2020 and December 2021. TMVR offers a treatment option for patients with high surgical risk, said Hell of the therapy, adding: “We have very promising results from the early feasibility studies, with very low mortality rates.”

Detailing the baseline patient data for the patient population, Hell reported that patients had a mean EuroScore II of 7.7, with a prior rate of hospitalisation for heart failure of 68%, and 81% of patients were in New York Heart Association (NYHA) functional class III/IV at baseline. In terms of MR aetiology, 40% had primary MR, 39% secondary, and 21% were classified as “mixed”. Severe calcification was found in 11% of patients.

Significantly, the investigators included patients who were treated for an off-label indication—totalling 33% (65) of the procedures—with the predominant reasons for off-label use

67% in 2020–2022. The data also point to a decline in Society of Thoracic Surgeons (STS) Score over time, spanning 5.7±4.5 in 2008–2013, 5.1±4 in 2014–2016, 4.8±3.5 in 2017–2019 and 4.8±3.9 in 2020–2022.

Turning to the safety endpoints, Koell reported that there was a decline in safety endpoints and reintervention rates from 2008 through to 2022, with no M-VARC safety endpoints reported in 45.8% of patients between 2008–2013, 43.3% between 2014–2016, 58% in 2017–2019, and 69.5% in 2020–2022. Reintervention rates within 12 months of the procedure stood at 4.8% in 2008–2013, 1.8% for the 2014–2016 period, 1.7% for 2017–2019, and 2.3% for 2020–2022.

Detailing the M-VARC safety endpoints he noted there was a low procedural mortality, with about 1% over time, also a low procedural stroke rate of about 1.2%, but what is important, is that we see a constant decrease in minor bleeding, major bleeding and minor vascular complications over time,” Koell reported.

The data also demonstrated gradually improving rates of residual MR at discharge, with none or trace MR reported in 70.7% of patients in 2020–2022, compared to 51.9% of patients at 2008–2013. including severe calcification or a prior mitral valve intervention or surgery. Outcome data were available for 186 of the 195 patients treated, with Hell reporting a 29% all-cause mortality rate and 17% cardiovascular mortality rate at one year, compared to rates of 9% and 7% for the same figures respectively at 30 days. Breaking these figures down for patients who were treated in an on- or off-label context, Hell noted that all-cause mortality rates stood at 27% and cardiovascular mortality at 15% for on-label patients, alongside 33% all-cause mortality and 21% cardiovascular mortality at one-year among the off-label patients.

“This is the largest registry on M-TEER in primary MR patients, and in this first preliminary analysis, we see that the complication rates constantly decline, and more importantly that the proportion of residual MR also gradually declines and the overall outcomes improve,” Koell concluded.

Turning to major adverse events, Hell reported that there was a reduction in heart failure hospitalisation from 66% at baseline to 29% at one year. Furthermore, the registry demonstrated a 1.6% overall rate of in-hospital disabling stroke, occurring exclusively in patients who received on-label treatment. Disabling stroke stood at 3% overall at one year, with an event rate of 1.1% in on-label patients and 7.3% in off-label patients.

Major bleeding—comprising Bleeding Academic Research Consortium (BARC) class 2, 3 or

5 bleeding—was reported in 14% of patients in hospital. At one year, 5.1% of patients required mitral valve reintervention or surgery, comprising 5.3% of on-label patients and 4.5% of off-label patients.

In terms of the reduction in MR seen among the patient cohort, Hell said that the registry data point toward “sustained improvement” at one year, with 99% of patients having MR grade 1 or 2 at one year. Improvements in NYHA functional class were also largely sustained out to the one-year timepoint, with 79% of patients remaining in NYHA class I or II. This was consistent across both on- and off-label patient cohorts, Hell detailed.

The data comprise “the largest series of commercial implants of a dedicated TMVR device,” Hell added, noting that the findings demonstrate “very similar low, one-year mortality rates, and even slightly lower severe mortality rates, compared to the previous early reports”. “We also showed a very durable clinical benefit, with an elimination of the MR and sustainability at one year. And, importantly of this registry, we can also say that there was no difference in survival outcomes of major adverse events between the on- and off-label indication groups,” Hell concluded.

Extended follow-up of the ISCHEMIA-EXTEND trial has shown no difference in rates of all-cause mortality with an initial invasive strategy when compared to a conservative strategy in patients with chronic coronary disease and moderate or severe ischaemia.

JUDITH S HOCHMAN (NEW YORK University School of Medicine, New York, USA) presented this interim conclusion, taken at a median of 5.7 years, in a late-breaking trial session at the American Heart Association Scientific Sessions (AHA 2022; 5–7 November, Chicago, USA). The findings were simultaneously published in Circulation ISCHEMIA-EXTEND follows on from the ISCHEMIA trial, looking at the potential benefit in adding cardiac catheterisation and revascularisation— with either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery—to optimal medical therapy in stable patients with at least moderate ischaemia on a stress test. Both patient groups in the study received guideline-directed medical therapy, with those in the conservative group treated invasively if symptoms worsened despite drug therapy or in the case of an emergency.

Hochman delivered the initial results of the trial at AHA 2019 (16–18 November, Philadelphia, USA), taken at a median of 3.2 years, and showing that the revascularisation strategy conferred no additional benefit when compared to the conservative approach.

Interim findings from the extended study presented at AHA 2022 included all 5,179 patients for whom data were collected in the initial trial, discounting