Structural Heart Interventions

prior pacemaker or implantable cardioverter defibrillator. The Evoque implant procedure was performed successfully in 94.4% of patients, with a relatively “short” implant time of 71.6 minutes needed on average per patient. Discharge to home was achieved in 91.1% of patients, with the length of hospital stay averaging three days.

Turning to the clinical results, Windecker detailed that cardiovascular mortality, which stood at 1.7% at 30 days, totalled 9.4% at one year. Further to this, no incidence of myocardial infarction (MI) was reported, there was a low rate of stroke (0.6% at 30 days and 1.3% at one year). Nonelective tricuspid valve reinterventions were observed in 4% of patients at one year and severe bleeding was 16.9% at one month and 25.5% at one year.

TRISCEND trial reports oneyear outcomes in patients undergoing transcatheter tricuspid valve implantation

One-year results from the TRISCEND study, investigating the Evoque (Edwards Lifesciences) tricuspid valve replacement system, show favourable safety, efficacy, echocardiographic and quality of life outcomes in patients with symptomatic tricuspid regurgitation (TR), investigators have reported.

Stephan Windecker (Bern University Hospital, Bern, Switzerland) presented the trial’s clinical, functional and echocardiographic outcomes at 12 months in a late-breaking trial session at PCR London Valves (27–29 November, London, UK), following on from encouraging results at both 30 days and six months.

TRISCEND is a prospective, multicentre, single-arm study, that has enrolled 176 patients with symptomatic, moderate or greater primary or secondary tricuspid regurgitation despite medical therapy at 20 sites across the USA, Canada, France and Switzerland.

In his presentation, Windecker detailed that the Evoque transcatheter valve replacement system consists of a selfexpanding nitinol frame, with a pericardial bovine valve and fabric skirt, delivered through a 28Fr transfemoral delivery system, inserted transvenously.

Summarising the patient characteristics, Windecker described the trial’s population as elderly, with a mean age of 78.7, largely female (71%), and noted that these patients had frequent comorbidities and three quarters of the patients were highly symptomatic with New York Heart Association class III‒IV. Additionally, 92% of patients had atrial fibrillation (AF), 22% ascites, and 32% of patients had had

There were no major cardiac structural complications and the composite major adverse event rate was 18.6% at 30 days and 30.2% at one year, Windecker reported. Pacemakers were implanted in 13.3% of patients within 30 days, but there was no further implant beyond 30 days. Furthermore, the results showed a 90.1% rate of survival at one year, alongside an 88.4% rate of freedom from heart failure hospitalisation.

Windecker also then presented serial core lab assessment of TR at both 30 days and one year versus baseline. He commented: “What you note is that the vast majority of patients that had severe, massive or torrential TR, in nearly 90% of cases at baseline was turned into an outcome where there was no, or only mild tricuspid regurgitation in 98% of patients. Of note, these changes were durable at all times of follow-up: 30 days, six months and one year, and there was the absence of any severe or more tricuspid regurgitation.

Outlining the echocardiographic results, which were adjudicated by core lab at one year, Windecker commented that there was evidence of right ventricular (RV) remodelling after Evoque implant, demonstrated by a change in mean RV end-diastolic mid diameter from 41.4mm at baseline to 35mm at one year and inferior vena cava (IVC) diameter was reduced from 27.6mm at baseline to 20.4mm at one year.

On functional and quality of life changes, Windecker commented that prior to the intervention, most of the patients were highly symptomatic, but after the intervention, 93% were oligosymptomatic with New York Heart Association (NYHA) classification I or II. “You see a remarkable difference in Kansas City Cardiomyopathy Questionnaire (KCCQ) score where a mean score of 46 increased to 17.7 with a change of 26,” noted Windecker.

“To give you an impression, any change of more than 20 is considered large or a very large improvement in these patients, and there was also a highly significant difference in the improvements of six-minute walk test of 56 metres.”

Summarising the message from the presentation, Windecker said the findings demonstrate “favourable survival and freedom from heart failure hospitalisation”.

“The core lab-adjudicated rates of TR reduction were remarkable, where 98% of patients had either no or only mild tricuspid regurgitation,” he added. “There was echocardiographic evidence of right ventricular remodelling and there were also significant clinically meaningful improvements in heart failure symptoms, and very beneficial development as it relates to quality-of-life measures, KCCQ score and the six-minute walk test.”

No sex difference seen in outcomes for transcatheter tricuspid valve intervention

TRANSCATHETER TRICUSPID VALVE intervention is associated with similar outcomes in both women and men, research published in the European Heart Journal indicates. Investigators also concluded that patients undergoing transcatheter therapy benefitted from increased one-year survival compared to those receiving solely medical therapy, regardless of their sex.

Authored by Andrea Scotti, Augustin Coisne (both Montefiore Health System, New York, USA) and colleagues, the research sought to offer clarity on whether sex has an impact on characteristics and outcomes in patients with significant tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve intervention.

“In our study, we showed that after transcatheter tricuspid valve intervention, clinical outcomes are similar in both women and men, with one-year survival rates of 81% and 78% respectively,” Scotti, Coisne et al write. “Similarly, the survival benefit of transcatheter tricuspid valve intervention over medical therapy was significant irrespective of sex.”

Using the TriValve registry—an international, multicentre, retrospective, multidevice registry evaluating tricuspid valve intervention—the researchers assessed data from 556 patients who underwent transcatheter tricuspid valve intervention at 24 centres between 2016–2021. Patients undergoing transcatheter therapy were compared to a control cohort of 2,072 medically managed patients with severe or greater TR, diagnosed at the Montefiore–Einstein Center for Heart and Vascular Care during 2015–2018.

The investigators report that after transcatheter therapy, there was no difference between women and men in one-year freedom from all-cause mortality (p=0.56), nor in heart failure hospitalisation (p=0.36), New York Heart Association (NYHA) Functional Classes II and IV (p=0.17), and TR severity >2+ at last follow-up. Multivariable Cox-regression weighted by inverse probability of treatment weighting (IPTW) showed improved one-year survival after transcatheter compared with medical therapy alone in both women (adjusted hazard ratio [HR] 0.45, 95% confidence interval [CI] 0.23–0.83) and men (adjusted HR 0.42, 95% CI 0.18–0.89, p=0.03).

Discussing the findings, the authors highlight that the baseline characteristics between women and men were not markedly different. “This may explain the discrepancies with surgical series, where women were at much higher risk compared with the male candidates,” the study team writes, adding that this stresses the importance of timely referral and management of tricuspid valve disease.