Anticoagulation Therapy After Biologic Aortic Valve Replacement.

Objectives: Thromboembolism prophylaxis after biologic aortic valve replacement (BAVR) is recommended for 3 months postoperatively. We examined the continuation of oral anticoagulation (OAC) treatment and its effect on the long-term prognosis after BAVR. Methods: We used nation-wide register data from 4,079 individuals who underwent BAVR. We examined the association between warfarin and the non-vitamin K antagonist oral anticoagulant use with death, stroke and major bleeding in 2010 - 2016. Results: The risk of stroke was higher (HR 2.39, 95% CI 1.62 - 3.53, p < 0.001) and the risk of death was lower (HR 0.79, 95% CI 0.65 - 0.96, p = 0.016) in OAC-users compared to individuals without OAC. We observed no significant associations between OAC use and bleeding risk. Conclusion: OAC use after BAVR was associated with increased risk of stroke and decreased risk of death. These observational findings warrant validation in randomized controlled trials before any clinical conclusions can be drawn.

Population trends in aortic valve surgery in Finland between 2001 and 2016.

Objectives. To investigate nationwide changes in procedure rates, patient selection, and prognosis after all surgical aortic valve replacements. Design. Patients undergoing primary surgical aortic valve replacement between 2001 and 2016 were identified from three nationwide registers with compulsory reporting to examine trends in aortic valve surgery over four four-year time periods. Results. A total of 12,139 surgical aortic valve replacement procedures (mean age 61.9 ± 11.8 years, 39.1% women) were performed. The total number of biological valves increased from 1001 (42.9%) to 2526 (75.5%) from 2001-2004 to 2013-2016 (p < .001). During the first and last time periods the comorbidity burden increased; share of patients with hypertension increased from 37.5% to 46.9% (p < .001), diabetes from 14% to 16.5% (p = .01) and previous stroke from 5.2% to 7.2% (p = .01). The proportion of women undergoing surgery decreased from 40% to 36.1% from 2001-2004 to 2013-2016, respectively (p = .01). Overall 28-day mortality was 3.5%. In patients with biologic valve the multivariable-adjusted risk of short-term mortality decreased steadily in every four-year period from 2001-2004 to 2005-2008 (HR, 0.66; 95% CI 0.47-9.92), 2009-2012 (HR, 0.54; 95% CI, 0.39-0.75) and 2013-2016 (HR, 0.41; 95% CI, 0.29-0.58), whereas short-term mortality remained similar in patients with mechanical valve. The risk of four-year postoperative mortality after all surgical aortic valve replacements stayed constant. Conclusions. The use of biologic aortic valve prosthesis has increased from 2001 to 2016. The proportion of women has declined markedly. The short-term mortality has decreased and the long-term mortality has stayed constant despite increasing comorbidity burden.

Sex Differences in Long-Term Outcomes After Surgical Aortic Valve Replacement: A Nationwide Propensity-matched Study.

OBJECTIVES: Women are considered to have poorer prognoses after cardiac surgery, although evidence is scarce. The authors studied sex differences and long-term outcomes after surgical aortic valve replacement (SAVR). DESIGN: Nationwide retrospective cohort study. SETTING: Six public hospitals and 2 private hospitals. PARTICIPANTS: All first-time SAVR (±coronary artery bypass surgery) patients (excluding endocarditis) aged ≥18 with a prosthetic valve were retrospectively identified from a national registry (n = 7616). Propensity score matching identified 2814 men and 2814 women with comparable baseline features. INTERVENTIONS: No intervention. MEASUREMENTS AND MAIN RESULTS: Outcomes were survival, major bleeding, ischemic stroke, infective endocarditis, and reoperation. Ten-year survival was 66.8% in men and 67.5% in women (hazard ratio [HR] 1.09; p = 0.107). Major bleeding occurred in 21.5% of men and 19.7% of women (HR 1.36; confidence interval [CI] 1.13-1.63; p = 0.0009) within 10 years, with similar results for mechanical and biological prosthesis. Bleeding was gastrointestinal in 38.5%, intracranial in 27.6%, and 33.9% in other sites with no sex difference in location. Ischemic stroke occurred in 12.5% of men and 13.3% of women within 10 years (HR 1.06; p = 0.614), and 4.7% of men and 2.6% of women (HR 1.77; CI 1.24-2.51; p = 0.001) had infective endocarditis, but association was present only with biological prosthesis (interaction p = 0.02). Aortic valve re-surgery was more common in men at 1 (HR 2.98; CI 1.27-7.00; p = 0.013) and 5 years after SAVR, but not at 10 years (2.4% v 3.8%; p = 0.189). CONCLUSIONS: Baseline-matched long-term survival after SAVR is similar between sexes. Men had increased risk of bleeding, early re-surgery after SAVR, and infective endocarditis when using biological prosthesis.

Long-term Outcomes of Mechanical Vs Biologic Aortic Valve Prosthesis in Patients Older Than 70 Years.

BACKGROUND: Biologic prostheses are preferred for surgical aortic valve replacement (SAVR) in patients more than 70 years of age in clinical practice. This study investigated differences in long-term outcomes between SAVR-treated patients more than 70 years of age who received mechanical or biologic prosthetic valves. METHODS: All patients (excluding those with endocarditis) who were more than 70 years of age and who underwent isolated first-time SAVR (with or without coronary artery bypass grafting) in Finland between 2004 and 2014 were retrospectively studied (n = 4227). Propensity score matching (1:3) was used to account for baseline differences (n = 296 with mechanical prostheses and n = 888 with biologic prostheses). Outcomes were 10-year survival, major bleeding (all, gastrointestinal, intracranial), ischemic stroke, infective endocarditis, and aortic valve reoperation. Mean age was 75.8 years, and mean follow-up was 8.3 years. RESULTS: Survival at 10 years was 46.1% with mechanical prostheses and 57.8% with biologic prostheses (hazard ratio [HR], 1.48; 95% confidence interval [CI], 1.21 to 1.80; P < .001; number needed to harm = 7.0). The 10-year major bleeding rates were 37.0% with mechanical valves and 18.8% with biologic valves (HR, 1.77; 95% CI, 1.25 to 2.49; P = .001; number needed to harm = 7.4). Both gastrointestinal bleeding (26.5% vs 8.9%; HR, 2.63; 95% CI, 1.63 to 4.23; P < .001) and intracranial bleeding (8.8% vs 6.0%; HR, 2.12; 95% CI, 1.09 to 4.15; P = .028) were significantly more frequent with mechanical valve prosthesis. Occurrence of ischemic stroke (18.9% with mechanical prosthesis vs 16.1% with biologic prosthesis; P = .341), infective endocarditis (3.7% vs 2.8%; P = .242), or aortic valve reoperation (0.8% vs 2.8%; P = .707) did not differ between study groups. CONCLUSIONS: Mechanical aortic valve prosthesis is associated with worse long-term survival and increased bleeding after SAVR in patients more than 70 years old. The study results suggest caution when considering mechanical aortic valve prostheses in elderly patients.

Population trends in mitral valve surgery in Finland between 1997 and 2014: the finnish CVD register.

OBJECTIVES: Contemporary, nationwide data on trends in mitral valve surgery are scarce. Our aim was to investigate changes in procedure rates, patient selection, and post-procedural prognosis of open-heart mitral valve surgery in Finland. DESIGN: We combined data from three nationwide administrative registers with compulsory reporting. We identified patients who had undergone first-ever open-heart mitral valve surgery between 1997 and 2014 and followed them for adverse events. We examined trends in mitral valve surgery over three six-year time periods (1997-2002, 2003-2008, and 2009-2014). RESULTS: 3684 mitral valve procedures (mean age: 67.0 ± 10.9 years, 42.6% women) were performed in 1997-2014 in Finland. During this period, mitral valve repair operations became more common than replacements and we observed an increasing trend in the use of bioprosthetic valves. Between 1997-2002 and 2009-2014, the mean age of patients undergoing mitral valve surgery and the proportion of urgent surgeries increased (p < .001 for both). The proportion of women undergoing surgery decreased while the share of patients with hypertension (p = .023) or diabetes (p = .026) increased. The multivariable-adjusted risk of 28-day (hazard ratio, 0.55; 95% confidence interval, 0.37-0.83) and 6-year (hazard ratio, 0.80; 95% confidence interval, 0.67-0.97) post-operative mortality was lower in the last six-year period than in 1994-1998. CONCLUSIONS: Short- and long-term mortality of mitral valve surgery patients in Finland has decreased from 1997 to 2014 despite the patients being older and having more comorbidities. Understanding the changing characteristics and prognosis of these patients is important for the interpretation of previous and future cohort studies and trials.