Journal and News Scan

The outcomes of the Transcatheter Aortic Valve Replacement in Low-Risk Patients at Five Years (5y PARTNER 3 trial) were presented during the late-breaking clinical trial session of TCT 2023 and simultaneously published in the New England Journal of Medicine. The results give valuable insights and add new evidence for the decision making and treatment of low-risk patients with severe symptomatic AS.

The PARTNER 3 trial randomly assigned 1,000 patients with severe symptomatic aortic stenosis (AS) and low surgical risk (STS-PROM < 4 percent) to undergo either transcatheter aortic valve replacement with a balloon expandable bioprosthesis (503 patients) or surgical aortic valve replacement (497 patients) with a prespecified superiority hypothesis. The two primary endpoints were composite of death, stroke, or rehospitalization, and hierarchical composite of death, disabling stroke, nondisabling stroke, and the number of rehospitalization days.

At five years, there was no significant difference in the risk of death, stroke, or rehospitalizations between the transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) arms. The Kaplan–Meier estimates were 22.8 percent vs. 27.2 percent in the TAVR and SAVR groups, respectively; p=0.07. Furthermore, Kaplan-Meier curves did not show a statistical difference in the five-year all-cause mortality. At five years, there was a mortality of 10.0 percent vs. 8.2 percent in the TAVR and SAVR groups, respectively; HR 1.23 and 95 percent CI 0.79-1.90. Remarkably, the Kaplan-Meier all-cause mortality curves initially showed an early result favoring TAVR, but beyond one year, attenuation of the observed differences occurred, with the curves crossing close to 36 months. The risk of cardiovascular (HR 1.08; 95 percent CI 0.61–1.92) and noncardiovascular (HR 1.46; 95 percent CI 0.74–2.90) mortality was similar in both groups. Valve hemodynamics were similar in both study arms, with a mean valve gradient 12.8±6.5 mmHg vs. 11.7±5.6 mmHg in the TAVR and SAVR groups, respectively. 

Moreover, bioprosthetic valve failure defined by VARC-3 criteria occurred at similarly low rates in both groups: 3.3 percent vs. 3.8 percent in the TAVR and SAVR groups, respectively. However, TAVR was associated with an increased risk of valve thrombosis: 0.2 percent vs. 2.5 percent; HR 10.52 (95 percent CI 1.37–80.93). Patient-reported health status was similar in the two groups, with a mean Kansas City Cardiomyopathy Questionnaire–Overall Summary score (KCCQ-OS) of 86.2 vs. 85.9 in the TAVR and SAVR groups, respectively. Similarly, 84.4 percent vs. 86.0 percent of the patients in the TAVR and SAVR groups presented with a New York Heart Association (NYHA) class I or II at five years, respectively.

The authors performed a structured review of the evidence surrounding the effect of donor age in lung transplantation. They examined whether or not lungs from donors over sixty years old had equivalent outcomes to lungs from younger donors. Twelve articles supplied the best evidence to answer this question. It was notable that recipients with interstitial lung disease, pulmonary hypertension, or cystic fibrosis had worse overall survival with grafts from older donors. The authors concluded that when allocated to the recipient who would most benefit, lung grafts from older donors offer results comparable to those obtained with younger donors.

This article brings attention to the need for representation of women in cardiovascular research trials, with women typically accounting for only 20 percent of participants. This comes following a Lancet commission aimed at reducing the global burden of cardiovascular disease in women. From this, investigators of the ROMA trial have launched ROMA-Women, given that women only represented 15 percent of their sample. The ROMA-Women trial is a nested design, one not previously seen in cardiovascular trials. This is achieved by leveraging the ROMA infrastructure and looks to be the first cardiac surgery trial dedicated to women.

Transcatheter pulmonary valve replacement (tPVR) is a key therapy in RVOT pathologies but is associated with long term risks such as infective endocarditis (IE). In fact, some reports claim a higher IE risk compared to surgical pulmonary valve replacement. This paper investigates outcomes to different management strategies used to treat IE in patients who underwent tPVR. A total of 69 cases were identified with 98 admissions due to a readmission rate of 29 percent. During the initial admission, surgical rates were 22 percent. Surgical rates were 36 percent overall, as the likelihood of surgical intervention increased with each subsequent admission. Mortality rate in the overall and surgical cohort was 4.3 percent and 8 percent respectively.