Predicted prosthesis-patient mismatch and long-term clinical outcomes after transcatheter aortic valve replacement: a SWEDEHEART study.

BACKGROUND: The impact of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) is uncertain. This study was performed to investigate the risk of all-cause mortality, heart failure hospitalization, and aortic valve reintervention in patients with and without predicted PPM after TAVR. METHODS: This nationwide, population-based cohort study included all patients who underwent transfemoral primary TAVR in Sweden from 2008 to 2022 in the SWEDEHEART register. PPM was defined according to published effective orifice areas for each valve model and size. The patients were divided into those with and without PPM. Additional baseline characteristics and outcome data were obtained from other national health data registers. Regression standardization was used to adjust for intergroup differences. RESULTS: Of 8485 patients, 7879 (93%) had no PPM and 606 (7%) had PPM. The crude cumulative incidence of all-cause mortality at 1, 5, and 10 years in patients with versus without PPM was 7% versus 9%, 40% versus 44%, and 80% versus 85%, respectively. After regression standardization, there was no between-group difference in long-term mortality, and the absolute difference at 10 years was 1.5% (95% confidence interval, -2.9%-6.0%). The mean follow-up was 3.0 years (maximum, 14 years). There was no difference in the risk of heart failure hospitalization or aortic valve reintervention. CONCLUSIONS: The risk of all-cause mortality, heart failure hospitalization, or aortic valve reintervention was not higher in patients with than without predicted PPM following TAVR. Furthermore, PPM was present in only 7% of patients, and severe PPM was almost nonexistent.

Early Creatinine Changes After Aortic Valve Replacement and Late Survival, Heart Failure, and Chronic Kidney Disease in a National Registry.

BACKGROUND: The impact of small increases in serum creatinine after surgical aortic valve replacement (SAVR) that fail to meet the acute kidney injury stage 1 criteria is unknown. The aim of this study was to investigate prognosis after primary SAVR in patients with small increases in postoperative serum creatinine. METHODS: This observational cohort study included all adult patients who underwent primary SAVR in Sweden from 2009 to 2022. The primary outcome was all-cause mortality. Secondary outcomes were chronic kidney disease and heart failure. Regression standardization addressed confounding. RESULTS: In 16,766 patients, 4074 (24.2%) had no change in postoperative serum creatinine, 5764 (34.3%) had a small increase in postoperative serum creatinine (0.06 mg/dL ≤ Δserum creatinine <0.3 mg/dL), and 2753 (16.4%) fulfilled the Kidney Disease Improving Global Outcomes acute kidney injury stage 1 criteria. The mean age was 67 years, and 31% of patients were female. No significant difference in long-term all-cause mortality was observed in the no change group at 13 years compared with the small increase group (absolute survival difference, 2.3% [95% CI, 0%-4.6%]). A stepwise increase in the risk of 30-day mortality was observed with increasing changes in serum creatinine. At 13 years of follow-up, there was a significant difference in the risk of chronic kidney disease (absolute difference, 2.8% [95% CI, 1.0%-4.5%]) and heart failure (absolute difference, 3.5% [95% CI, 1.3%-5.7%]) between the no change and small increase groups. CONCLUSIONS: A small increase in postoperative serum creatinine after SAVR was associated with an increased risk of adverse outcomes. The acute kidney injury definition may benefit from including more reliable and specific biomarkers together with small creatinine increases to detect kidney injury.

Bleeding in minimally invasive versus conventional aortic valve replacement.

BACKGROUND: Observational studies have shown reduced perioperative bleeding in patients undergoing minimally invasive, compared with full sternotomy, aortic valve replacement. Data from randomized trials are conflicting. METHODS: This was a Swedish single center study where adult patients with aortic stenosis, 100 patients were randomly assigned in a 1:1 ratio to undergo either minimally invasive (ministernotomy) or full sternotomy aortic valve replacement. The primary outcome was severe or massive bleeding defined by the Universal Definition of Perioperative Bleeding in adult cardiac surgery (UDPB). Secondary outcomes included blood product transfusions, chest tube output, re-exploration for bleeding, and several other clinically relevant events. RESULTS: Out of 100 patients, three patients randomized to ministernotomy were intraoperatively converted to full sternotomy (none was bleeding-related). Three patients (6%) in the full sternotomy group and 3 patients (6%) in the ministernotomy group suffered severe or massive postoperative bleeding according to the UDPB definition (p = 1.00). Mean chest tube output during the first 12 postoperative hours was 350 (standard deviation (SD) 220) ml in the full sternotomy group and 270 (SD 190) ml in the ministernotomy group (p = 0.08). 28% of patients in the full sternotomy group and 36% of patients in the ministernotomy group received at least one packed red blood cells transfusion (p = 0.39). Two patients in each group (4%) underwent re-exploration for bleeding. CONCLUSIONS: Minimally invasive aortic valve replacement did not result in less bleeding-related outcomes compared to full sternotomy. CLINICAL TRIAL REGISTRATION: http://www. CLINICALTRIALS: gov . Unique identifier: NCT02272621.

Skeletonized Versus Pedicled Harvesting of the Internal Thoracic Artery and Long-Term Clinical Outcomes in Coronary Artery Bypass Surgery.

BACKGROUND: The internal thoracic artery (ITA) is the most important conduit for coronary artery bypass grafting. Recent evidence suggests that skeletonized ITA harvesting yields long-term outcomes inferior to those of pedicled harvesting. The aim was to investigate the impact of the ITA harvesting method on 10-year mortality and major adverse cardiovascular events. METHODS AND RESULTS: In this observational cohort study, we identified all patients from the SWEDEHEART (Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) register who underwent isolated coronary artery bypass grafting using at least 1 ITA at Karolinska University Hospital from 2012 to 2021. The main outcome was all-cause mortality, and the secondary outcomes were a combination of myocardial infarction, repeat revascularization, heart failure, and stroke. Outcomes were ascertained using national health data registers and compared between the skeletonized and pedicled groups using weighted flexible parametric survival models. Among 3267 patients, 1657 (51%) underwent pedicled ITA harvesting and 1610 (49%) underwent skeletonized ITA harvesting. The patients' mean age was 66 years, and 15% were women. The weighted all-cause mortality incidence rate in the pedicled versus skeletonized ITA group was 2.6% (95CI, 2.2%-3.0%) versus 2.6% (95% CI, 2.2%-3.1%), respectively (hazard ratio (HR), 1.01 [95% CI, 0.81-1.27]). The weighted major adverse cardiovascular events incidence rate was 7.8% (95% CI, 7.1%-8.6%) versus 7.5% (95% CI, 6.7%-8.4%), respectively (HR, 0.94 [95% CI, 0.82-1.08]). CONCLUSIONS: We found no significant differences in all-cause mortality or major adverse cardiovascular events rates between the 2 ITA harvesting methods.

Transcatheter Aortic Valve Implantation in Low-Risk Tricuspid or Bicuspid Aortic Stenosis: The NOTION-2 Trial.

BACKGROUND AND AIMS: Transcatheter aortic valve implantation (TAVI) has become the first choice to treat older patients with severe symptomatic aortic stenosis (AS). This study aimed to compare TAVI with surgery in low-risk patients ≤ 75 years of age, including both tricuspid and bicuspid AS. METHODS: The NOTION-2 trial enrolled and 1:1 randomized low-risk patients aged ≤ 75 years with severe symptomatic AS to TAVI or surgery. The primary endpoint was a composite of all-cause mortality, stroke or rehospitalization (related to the procedure, valve or heart failure) at 12 months. RESULTS: A total of 370 patients were enrolled with a mean age of 71.1 years and a median Society of Thoracic Surgeons risk score of 1.1%. A total of 100 patients had bicuspid AS. The 1-year incidence of the primary endpoint was 10.2% in the TAVI group and 7.1% in the surgery group (absolute risk difference 3.1%; 95% confidence interval [CI], -2.7% to 8.8%; hazard ratio (HR) 1.4, 95% CI: 0.7 to 2.9; p=0.3). Patients with TAVI, when compared to surgery, had lower risk of major bleeding and new-onset atrial fibrillation and higher risk of non-disabling stroke, permanent pacemaker implantation and moderate-or-greater paravalvular regurgitation. The risk of the primary composite endpoint was 8.7% and 8.3% in patients with tricuspid AS (HR 1.0, 95% CI: 0.5 to 2.3) and 14.3% and 3.9% in patients with bicuspid AS (HR 3.8, 95% CI: 0.8 to 18.5) treated with TAVI or surgery, respectively (P for interaction=0.1). CONCLUSIONS: Among low-risk patients aged ≤ 75 years with severe symptomatic AS, the rate of the composite of death, stroke, or rehospitalization at one year was similar between TAVI and surgery. TAVI outcomes in young bicuspid AS patients warrant caution and should be further investigated. (NOTION-2, ClinicalTrials.gov, NCT02825134).

Comparative Long-Term Clinical Performance of Mechanical Aortic Valve Prostheses.

Importance: Aggregated data and long-term follow-up in national health data registers offer the opportunity to compare the performance of mechanical aortic prostheses within the same population. Objective: To investigate the clinical performance of mechanical aortic valve prostheses. Design, Setting, and Participants: This nationwide cohort study included all 5224 patients who underwent primary mechanical aortic valve replacement in Sweden between January 1, 2003, and December 31, 2018. Statistical analysis was performed between May and September 2023. Exposures: Surgical aortic valve replacement with the On-X, Carbomedics, Bicarbon, Standard, Regent, Open Pivot, Masters, or Advantage valve models. Main Outcomes and Measures: The primary outcome was all-cause mortality, and secondary outcomes were reintervention, heart failure, major bleeding, stroke, and embolic events. Regression standardization was used to account for baseline differences. Results: Overall, 5224 patients (mean [SD] age, 56.8 [11.7] years; 3908 men [74.8%]) were included. Total follow-up time was 43 982 person-years (mean [SD], 8.4 [4.6] years; maximum, 17.2 years). After regression standardization, there was a significant difference in 10-year mortality between the Carbomedics model group (17%; 95% CI, 15%-18%), Regent model group (17%; 95% CI, 13%-20%), and Standard model group (17%; 95% CI, 14%-19%) compared with the Bicarbon model group (27%; 95% CI, 21%-34%). Conclusions and Relevance: In this cohort study of mechanical valve surgical aortic replacement outcomes in Sweden, the rate of all-cause mortality was higher in the Bicarbon group than in the Carbomedics, Regent, and Standard model groups. These findings warrant further research on the long-term clinical performance of the Bicarbon valve.

The effect of continuous bilateral parasternal block with lidocaine on patient-controlled analgesia opioid requirement and recovery after open heart surgery: a double-blind randomised controlled trial.

Background: We hypothesised that a continuous 72-h bilateral parasternal infusion of lidocaine at 2×35 mg h-1 would decrease pain and the inflammatory response after sternotomy for open heart surgery, subsequently improving quality of recovery. Methods: We randomly allocated 45 participants to a 72-h bilateral parasternal infusion of lidocaine or saline commencing after wound closure. The primary outcome was the cumulative patient-controlled analgesia (PCA) morphine consumption at 72 h. Secondary outcomes included total morphine requirement, pain, peak expiratory flow, and serum interleukin-6 concentration. In addition, we used an eHealth platform for a 3-month follow-up of pain, analgesic use, and Quality of Recovery-15 scores. Results: The 72-h PCA morphine requirement was significantly lower in the lidocaine than the saline group (10 mg [inter-quartile range: 5-19 mg] and 28.2 mg [inter-quartile range: 16-42.5 mg], respectively; P=0.014). The total morphine requirement (including morphine administered before the start of PCA) was significantly lower at 24, 48, and 72 h. Pain was well controlled with no difference in pain scores between treatment groups. The peak expiratory flow was lower in the lidocaine group at 72 h. Interleukin-6 concentrations showed no difference at 24, 48, or 72 h. Quality of Recovery-15 scores did not differ between treatment groups at any time during the 3-month follow-up. Conclusions: After sternotomy for open heart surgery, a 72-h bilateral parasternal lidocaine infusion significantly decreased PCA and total morphine requirement. However, neither signs of decreased inflammatory response nor an improvement in recovery was seen. Clinical trial registration: EudraCT number 2018-004672-35.

Self-reported preoperative depressive symptoms and survival after cardiac surgery.

OBJECTIVES: Depression has been associated with increased cardiovascular morbidity and mortality. This study aimed to determine whether self-reported preoperative depressive symptoms were associated with worse long-term survival in patients undergoing cardiac surgery. METHODS: This population-based, observational cohort study included patients who had undergone cardiac surgery at Karolinska University Hospital between 2013 and 2016. Self-reported data about depressive symptoms were collected using the Patient Health Questionnaire (PHQ-9) and other patient data were collected from the institutional surgical database and medical charts. Depression was defined as a PHQ-9 score ≥10. Weighted flexible parametric survival models were used to estimate the association between self-reported preoperative depressive symptoms and all-cause mortality and to quantify absolute survival differences. RESULTS: Of the 1120 study patients, 162 (14.5%) had depressive symptoms before cardiac surgery. During a mean follow-up of 7.2 years (maximum, 9.2 years), there were 36 deaths in 1129 person-years (PYs) in the depressed group, compared to 160 deaths in 6889 PYs in the non-depressed group. In the adjusted analysis, self-reported depressive symptoms were associated with worse long-term survival (hazard ratio 1.66; 95% confidence interval 1.09-2.54) compared with no reported depressive symptoms. The absolute survival differences (% and 95% confidence interval) between the non-depressed and the depressed patients were -1.9 (-3.9 to 0.19), -5.7 (-11 to -0.01) and -9.7 (-19 to -0.4) after 1, 5 and 8 years, respectively. CONCLUSIONS: Self-reported preoperative depressive symptoms were associated with worse long-term survival following cardiac surgery and should be regarded as important as other classical risk factors.

Uniportal video-assisted thoracic surgery: segmentectomy versus lobectomy-early outcomes.

OBJECTIVES: To assess the feasibility and safety of uniportal video-assisted thoracoscopic pulmonary segmentectomy compared with lobectomy by studying early postoperative outcomes. METHODS: We included all patients who underwent uniportal segmentectomy and lobectomy between 2017 and 2022 at Karolinska University Hospital. Early clinical outcomes were compared between the uniportal segmentectomy and lobectomy groups. Differences in baseline characteristics were addressed using inverse probability of treatment weighting. RESULTS: A total of 833 patients (232 segmentectomy, 601 lobectomy) were included. The number of uniportal operations increased during the study period. Patients in the segmentectomy and lobectomy groups, respectively, had stage I lung cancer in 65% and 43% of the cases; 97% and 94% had no postoperative complications, the median number of lymph node stations sampled was 4 vs 5, and non-radical microscopic resection occurred in 1.7% vs 1.8%. The drains were removed on postoperative day 1 in 75% vs 72% of the patients following segmentectomy and lobectomy, respectively, and 90% vs 89% were discharged directly home. CONCLUSIONS: Uniportal video-assisted segmentectomy was performed with similar early postoperative clinical results compared with uniportal lobectomy in patients with benign, metastatic or early-stage lung cancer.

Association of Preoperative Renal-Resistive Index With Long-term Renal and Cardiovascular Outcomes After Cardiac Surgery.

OBJECTIVE: To investigate the association of elevated preoperative renal-resistive index (RRI) with persistent renal dysfunction, major adverse kidney events (MAKE), and major adverse cardiovascular events (MACE) after cardiac surgery. DESIGN: Observational cohort study. SETTING: University hospital. PARTICIPANTS: Ninety-six adult patients undergoing cardiac surgery. INTERVENTIONS: RRI measurement the day before surgery. MEASUREMENTS AND MAIN RESULTS: Fifty-eight patients (60%) had elevated RRI ≥0.70. Five years after surgery, persistent renal dysfunction (sustained decline in estimated glomerular filtration rate ≥25%) had occurred in 25 patients (26%), MAKE (persistent renal dysfunction, renal replacement therapy, or death) in 34 (35%), and MACE (myocardial infarction, unstable angina, decompensated heart failure, stroke, or cardiovascular death) in 28 (29%). RRI was higher in patients who developed persistent renal dysfunction (median, 0.78 [IQR, 0.74-0.82] v 0.70 [0.66-0.77], p = 0.001), MAKE (0.77 [0.72-0.81] v 0.68 [0.65-0.76], p = 0.002), and MACE (0.77 [0.72-0.81] v 0.70 [0.66-0.77], p = 0.006). Patients with elevated RRI had a significantly higher cumulative incidence of all long-term outcomes. After adjustment for baseline renal function and heart failure, elevated RRI was associated with persistent renal dysfunction (hazard ratio [HR], 5.82 [95% CI, 1.71-19.9]), MAKE (HR, 4.21 [1.59-11.1]), and MACE (HR, 2.81 [1.03-7.65]). CONCLUSIONS: Elevated preoperative RRI is associated with persistent renal dysfunction, MAKE, and MACE after cardiac surgery. Preoperative RRI may be used for long-term risk assessment in patients undergoing cardiac surgery.

Prosthetic Valve Endocarditis After Aortic Valve Replacement With Bovine Versus Porcine Bioprostheses.

BACKGROUND: Whether a bovine or porcine aortic valve bioprosthesis carries a higher risk of endocarditis after aortic valve replacement is unknown. The aim of this study was to compare the risk of prosthetic endocarditis in patients undergoing aortic valve replacement with a bovine versus porcine bioprosthesis. METHODS AND RESULTS: This nationwide, population-based cohort study included all patients who underwent surgical aortic valve replacement with a bovine or porcine bioprosthesis in Sweden from 1997 to 2018. Regression standardization was used to account for intergroup differences. The primary outcome was prosthetic valve endocarditis, and the secondary outcomes were all-cause mortality and early prosthetic valve endocarditis. During a maximum follow-up time of 22 years, we included 21 022 patients, 16 603 with a bovine valve prosthesis and 4419 with a porcine valve prosthesis. The mean age was 73 years, and 61% of the patients were men. In total, 910 patients were hospitalized for infective endocarditis: 690 (4.2%) in the bovine group and 220 (5.0%) in the porcine group. The adjusted cumulative incidence of prosthetic valve endocarditis at 15 years was 9.5% (95% CI, 6.2%-14.4%) in the bovine group and 2.8% (95% CI, 1.4%-5.6%) in the porcine group. The absolute risk difference between the groups at 15 years was 6.7% (95% CI, 0.8%-12.5%). CONCLUSIONS: The risk of endocarditis was higher in patients who received a bovine compared with a porcine valve prosthesis after surgical aortic valve replacement. This association should be considered in patients undergoing both surgical and transcatheter aortic valve replacement.

Extrapleural infusion of levobupivacaine versus levobupivacaine-sufentanil-adrenaline after video-assisted thoracoscopic surgery (VATS): A randomised controlled trial.

BACKGROUND: Peripheral blocks are increasingly used for analgesia after video-assisted thoracic surgery (VATS). We hypothesised that addition of sufentanil and adrenaline to levobupivacaine would improve the analgesic effect of a continuous extrapleural block. METHODS: We randomised 60 patients undergoing VATS to a 5-mL h-1 extrapleural infusion of levobupivacaine at 2.7 mg mL-1 (LB group) or levobupivacaine at 1.25 mg mL-1 , sufentanil at 0.5 µg mL-1 , and adrenaline at 2 µg mL-1 (LBSA group). The primary outcome was the cumulative morphine dose administered as patient-controlled analgesia (PCA-morphine) at 48 and 72 h. The secondary outcomes were pain according to numerical rating scale (NRS) at rest and after two deep breaths twice daily, peak expiratory flow (PEF) daily, quality of recovery (QoR)-15 score at 1 day and 3 weeks postoperatively, serum levobupivacaine concentrations at 1 h after the start and at the end of the intervention, and adverse events. RESULTS: At 48 h, the median cumulative PCA-morphine dose for the LB group was 6 mg (IQR, 2-10 mg) and for the LBSA group 7 mg (IQR, 3-13.5 mg; p = .378). At 72 h, morphine doses were 10 mg (IQR, 3-22 mg) and 12.5 mg (IQR, 4-21 mg; p = .738), respectively. Median NRS score at rest and after two deep breaths was 3 or lower at all time points for both treatment groups. PEF did not differ between groups. Three weeks postoperatively, only the LB group returned to baseline QoR-15 score. The LB group had higher, but well below toxic, levobupivacaine concentrations at 48 and 72 h. The incidence of nausea, dizziness, pruritus and headache was equally low overall. CONCLUSION: For a continuous extrapleural block, and compared to plain levobupivacaine at 13.5 mg h-1 , levobupivacaine at 6.25 mg h-1 with addition of sufentanil and adrenaline did not decrease postoperative morphine consumption. The levobupivacaine serum concentrations after 48 and 72 h of infusion were well below toxic levels, therefore our findings support the use of the maximally recommended dose of levobupivacaine for a 2- to 3-day continuous extrapleural block.

Quality of life and functional status after pulmonary endarterectomy for chronic thromboembolic pulmonary hypertension: A Swedish single-center study.

Little is known about long-term quality of life (QOL) and functional status after pulmonary endarterectomy (PEA) for chronic thromboembolic pulmonary hypertension (CTEPH). We investigated QOL and functional status late after PEA. All patients who underwent PEA for CTEPH 1993-2020 at one Swedish center were included. Baseline characteristics and data from right heart catheterization, 6-min walk test, and Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) were obtained from patient charts and national registers. The RAND 36-Item Health Survey was sent by post, and Karnofsky Performance Status (KPS) was evaluated by telephone. A total of 110 patients were included. The survey was completed by 49/66 (74%) patients who were alive in 2020. In all domains except for bodily pain, QOL was slightly lower than that of an age-matched reference population. The KPS score was obtained from 42/49 (86%) patients; of these, 31 patients (74%) had a KPS score of ≥80% (able to carry on normal activity). All 42 patients were able to live at home and care for personal needs. The median postoperative CAMPHOR scores were: 4 for symptoms, 4 for activity, and 2.5 for QOL. We observed that QOL after PEA approached the expected QOL in a reference population and that CAMPHOR scores were comparable to those of a large UK cohort after PEA. Functional status improved when assessed late after PEA. Three-quarters of the study population were able to conduct normal activities at late follow-up. Our findings suggest that many patients enjoy satisfactory QOL and high functional status late after PEA.

Effect of Prosthesis-Patient Mismatch on Long-Term Clinical Outcomes After Bioprosthetic Aortic Valve Replacement.

BACKGROUND: Prosthesis-patient mismatch (PPM) is common following surgical aortic valve replacement (SAVR). OBJECTIVES: The purpose of this study was to quantify the impact of PPM on all-cause mortality, heart failure hospitalization, and reintervention following bioprosthetic SAVR. METHODS: This observational nationwide cohort study from SWEDEHEART (Swedish Web system for Enhancement and Development of Evidence based care in Heart disease Evaluated According to Recommended Therapies) and other national registers included all patients who underwent primary bioprosthetic SAVR in Sweden from 2003 to 2018. PPM was defined according to the Valve Academic Research Consortium 3 criteria. Outcomes were all-cause mortality, heart failure hospitalization, and aortic valve reintervention. Regression standardization was used to account for intergroup differences and to estimate cumulative incidence differences. RESULTS: We included 16,423 patients (no PPM: 7,377 [45%]; moderate PPM: 8,502 [52%]; and severe PPM: 544 [3%]). After regression standardization, the cumulative incidence of all-cause mortality at 10 years was 43% (95% CI: 24%-44%) in the no PPM group compared with 45% (95% CI: 43%-46%) and 48% (95% CI: 44%-51%) in the moderate and severe PPM groups, respectively. The survival difference at 10 years was 4.6% (95% CI: 0.7%-8.5%) and 1.7% (95% CI: 0.1%-3.3%) in no vs severe PPM and no vs moderate PPM, respectively. The difference in heart failure hospitalization at 10 years was 6.0% (95% CI: 2.2%-9.7%) in severe vs no PPM. There was no difference in aortic valve reintervention in patients with or without PPM. CONCLUSIONS: Increasing grades of PPM were associated with long-term mortality, and severe PPM was associated with increased heart failure. Moderate PPM was common, but the clinical significance may be negligible because the absolute risk differences in clinical outcomes were small.

Dual or single antiplatelet therapy after coronary surgery for acute coronary syndrome (TACSI trial): Rationale and design of an investigator-initiated, prospective, multinational, registry-based randomized clinical trial.

The TACSI trial (ClinicalTrials.gov Identifier: NCT03560310) tests the hypothesis that 1-year treatment with dual antiplatelet therapy with acetylsalicylic acid (ASA) and ticagrelor is superior to only ASA after isolated coronary artery bypass grafting (CABG) in patients with acute coronary syndrome. The TACSI trial is an investigator-initiated pragmatic, prospective, multinational, multicenter, open-label, registry-based randomized trial with 1:1 randomization to dual antiplatelet therapy with ASA and ticagrelor or ASA only, in patients undergoing first isolated CABG, with a planned enrollment of 2200 patients at Nordic cardiac surgery centers. The primary efficacy end point is a composite of time to all-cause death, myocardial infarction, stroke, or new coronary revascularization within 12 months after randomization. The primary safety end point is time to hospitalization due to major bleeding. Secondary efficacy end points include time to the individual components of the primary end point, cardiovascular death, and rehospitalization due to cardiovascular causes. High-quality health care registries are used to assess primary and secondary end points. The patients will be followed for 10 years. The TACSI trial will give important information useful for guiding the antiplatelet strategy in acute coronary syndrome patients treated with CABG.

Aortic Valve Replacement With Mechanical Valves vs Perimount Bioprostheses in 50- to 69-Year-Old Patients.

Background: Evidence is mixed regarding the most appropriate type of valve prosthesis for surgical aortic valve replacement (AVR) in patients 50 to 69 years. American and European guidelines differ. Objectives: The purpose of this study was to determine the long-term all-cause mortality and complication rates after AVR in patients aged 50 to 69 years according to implantation of a Perimount bioprosthetic valve or a mechanical valve. Methods: In this nationwide observational cohort study, all patients aged 50 to 69 years who underwent primary surgical AVR in Sweden 2003 to 2018 using a Perimount bioprosthesis or mechanical valve were identified from the SWEDEHEART register. Primary outcome; all-cause mortality, secondary outcomes; major bleeding, aortic valve reintervention, heart failure hospitalization, and stroke. National health-data registers were used to ascertain outcomes. Regression standardization addressed confounding. Results: A total of 6,907 patients aged 50 to 69 years were included (Perimount group, n = 3,831 and mechanical valve group, n = 3,076) and 74% were men. The use of bioprostheses increased during the study period. At 15 years of follow-up, the estimated cumulative incidence of all-cause mortality was 37% (95% CI: 35%-40%) vs 45% (95% CI: 42%-48%) in the mechanical and Perimount groups, respectively (survival difference -7.9% [95% CI: -11% to -4.6%]). Patients with mechanical valves had a lower risk of aortic valve reintervention but a higher risk for bleeding. Survival difference at 15 years in ages 50 to 59 years was -15% (95% CI: -8.4% to -21%). Conclusions: In patients aged 50 to 69 years who underwent surgical AVR, survival was better in those who received mechanical compared to Perimount bioprosthetic valves. While valve choice should be guided by individual patient factors and patient preference rather than by chronological age, the substantial survival advantage observed in patients with mechanical valves in ages 50 to 59 years must be recognized.

Surgery for endocarditis in patients with bicuspid aortic valves.

Background: The objective of this study is to investigate clinical outcomes in patients with bicuspid aortic valves (BAV) after surgical treatment for endocarditis. Methods: This was a population-based, observational cohort study, conducted on all patients who received aortic valve surgery for native or prosthetic valve endocarditis at Karolinska University Hospital between 2002-2020. Baseline characteristics and postoperative complications were collected from the institutional surgical database and patient medical charts. The primary endpoint was all-cause mortality. We used unadjusted and adjusted Cox regression to determine the association between valve morphology and long-term mortality. Results: Of the 338 patients, 122 (36%) had a BAV and 216 (64%) had a tricuspid aortic valve (TAV). The mean follow-up was 5.8 years (maximum 18.4 years). Survival rates at one, five, ten and 14 years were 88%, 81%, 78% and 76% versus 85%, 69%, 58% and 43%, in BAV and TAV patients, respectively [adjusted hazard ratio (HR) 0.64; 95% confidence interval (CI): 0.39-1.05]. In patients with native valve endocarditis, those with BAV had lower all-cause mortality compared to those with TAV (adjusted HR 0.44; 95% CI: 0.22-0.89), despite having a higher prevalence of perivalvular abscess (40% versus 22%, respectively, in BAV and TAV patients). In patients with prosthetic valve endocarditis, original valve morphology did not affect all-cause mortality (adjusted HR 1.94; 95% CI: 0.64-5.87). Conclusions: In patients with native valve endocarditis, a BAV was associated with improved survival after surgical treatment. In patients with prosthetic valve endocarditis, survival was not affected by the original valve morphology of the patient.