Long-Term Clinical and Echocardiographic Outcomes Following the Ross Procedure

IMPORTANCE:The Ross procedure as treatment for adults with aortic valve disease (AVD) has been the subject of renewed interest. OBJECTIVE:To evaluate the long-term clinical and echocardiographic outcomes following the Ross procedure for the treatment of adults with AVD. DESIGN, SETTING, AND PARTICIPANTS:This post hoc analysis of a randomized clinical trial included adult patients (age &lt;69 years) who underwent a Ross procedure for the treatment of AVD, including those with active endocarditis, rheumatic AVD, decreased ejection fraction, and previous cardiac surgery. The trial, conducted from September 1, 1994, to May 31, 2001, compared homograft root replacement with the Ross procedure at a single center. Data after 2010 were collected retrospectively in November and December 2022. EXPOSURE:Ross procedure. MAIN OUTCOMES AND MEASURES:The primary end point was long-term survival among patients who underwent the Ross procedure compared with that in the age-, country of origin– and sex-matched general population. Secondary end points were freedom from any reintervention, autograft reintervention, or homograft reintervention and time-related valve function, autograft diameter, and functional status. RESULTS:This study included 108 adults (92 [85%] male) with a median age of 38 years (range, 19-66 years). Median duration of clinical follow-up was 24.1 years (IQR, 22.6-26.1 years; 2488 patient-years), with 98% follow-up completeness. Of these patients, 9 (8%) had active endocarditis and 45 (42%) underwent reoperations. The main hemodynamic lesion was stenosis in 30 (28%) and regurgitation in 49 (45%). There was 1 perioperative death (0.9%). Twenty-five year survival was 83.0% (95% CI, 75.5%-91.2%), representing a relative survival of 99.1% (95% CI, 91.8%-100%) compared with the general population (83.7%). At 25 years, freedom from any reintervention was 71.1% (95% CI, 61.6%-82.0%); from autograft reintervention, 80.3% (95% CI, 71.9%-89.6%); and from homograft reintervention, 86.3% (95% CI, 79.0%-94.3%). Thirty-day mortality after the first Ross-related reintervention was 0% and after all Ross-related reinterventions was 3.8% (n = 1); 10-year survival after reoperation was 96.2% (95% CI, 89.0%-100%).CONCLUSIONS AND RELEVANCE:This study found that the Ross procedure provided excellent survival into the third decade postoperatively that was comparable to that in the general population. Long-term freedom from reintervention demonstrated that the Ross procedure may be a durable substitute into late adulthood, showing a delayed but progressive functional decline.</p

Long-Term Clinical and Echocardiographic Outcomes Following the Ross Procedure:A Post Hoc Analysis of a Randomized Clinical Trial

IMPORTANCE:The Ross procedure as treatment for adults with aortic valve disease (AVD) has been the subject of renewed interest. OBJECTIVE:To evaluate the long-term clinical and echocardiographic outcomes following the Ross procedure for the treatment of adults with AVD. DESIGN, SETTING, AND PARTICIPANTS:This post hoc analysis of a randomized clinical trial included adult patients (age &lt;69 years) who underwent a Ross procedure for the treatment of AVD, including those with active endocarditis, rheumatic AVD, decreased ejection fraction, and previous cardiac surgery. The trial, conducted from September 1, 1994, to May 31, 2001, compared homograft root replacement with the Ross procedure at a single center. Data after 2010 were collected retrospectively in November and December 2022. EXPOSURE:Ross procedure. MAIN OUTCOMES AND MEASURES:The primary end point was long-term survival among patients who underwent the Ross procedure compared with that in the age-, country of origin– and sex-matched general population. Secondary end points were freedom from any reintervention, autograft reintervention, or homograft reintervention and time-related valve function, autograft diameter, and functional status. RESULTS:This study included 108 adults (92 [85%] male) with a median age of 38 years (range, 19-66 years). Median duration of clinical follow-up was 24.1 years (IQR, 22.6-26.1 years; 2488 patient-years), with 98% follow-up completeness. Of these patients, 9 (8%) had active endocarditis and 45 (42%) underwent reoperations. The main hemodynamic lesion was stenosis in 30 (28%) and regurgitation in 49 (45%). There was 1 perioperative death (0.9%). Twenty-five year survival was 83.0% (95% CI, 75.5%-91.2%), representing a relative survival of 99.1% (95% CI, 91.8%-100%) compared with the general population (83.7%). At 25 years, freedom from any reintervention was 71.1% (95% CI, 61.6%-82.0%); from autograft reintervention, 80.3% (95% CI, 71.9%-89.6%); and from homograft reintervention, 86.3% (95% CI, 79.0%-94.3%). Thirty-day mortality after the first Ross-related reintervention was 0% and after all Ross-related reinterventions was 3.8% (n = 1); 10-year survival after reoperation was 96.2% (95% CI, 89.0%-100%).CONCLUSIONS AND RELEVANCE:This study found that the Ross procedure provided excellent survival into the third decade postoperatively that was comparable to that in the general population. Long-term freedom from reintervention demonstrated that the Ross procedure may be a durable substitute into late adulthood, showing a delayed but progressive functional decline.</p

Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial

BackgroundTocilizumab blocks pro-inflammatory activity of interleukin-6 (IL-6), involved in pathogenesis of pneumonia the most frequent cause of death in COVID-19 patients.MethodsA multicenter, single-arm, hypothesis-driven trial was planned, according to a phase 2 design, to study the effect of tocilizumab on lethality rates at 14 and 30 days (co-primary endpoints, a priori expected rates being 20 and 35%, respectively). A further prospective cohort of patients, consecutively enrolled after the first cohort was accomplished, was used as a secondary validation dataset. The two cohorts were evaluated jointly in an exploratory multivariable logistic regression model to assess prognostic variables on survival.ResultsIn the primary intention-to-treat (ITT) phase 2 population, 180/301 (59.8%) subjects received tocilizumab, and 67 deaths were observed overall. Lethality rates were equal to 18.4% (97.5% CI: 13.6-24.0, P=0.52) and 22.4% (97.5% CI: 17.2-28.3, P&lt;0.001) at 14 and 30 days, respectively. Lethality rates were lower in the validation dataset, that included 920 patients. No signal of specific drug toxicity was reported. In the exploratory multivariable logistic regression analysis, older age and lower PaO2/FiO2 ratio negatively affected survival, while the concurrent use of steroids was associated with greater survival. A statistically significant interaction was found between tocilizumab and respiratory support, suggesting that tocilizumab might be more effective in patients not requiring mechanical respiratory support at baseline.ConclusionsTocilizumab reduced lethality rate at 30 days compared with null hypothesis, without significant toxicity. Possibly, this effect could be limited to patients not requiring mechanical respiratory support at baseline.Registration EudraCT (2020-001110-38); clinicaltrials.gov (NCT04317092)