Long-Term Outcomes Associated With Permanent Pacemaker Implantation in Low-Risk Surgical Aortic Valve Replacement.

Background: Permanent pacemaker implantation is associated with an increased risk of mortality and heart failure after surgical aortic valve replacement (SAVR). Objectives: The purpose of this study was to analyze long-term prognosis of permanent pacemaker implantation following SAVR on low-risk patients. Methods: This nationwide, population-based, observational cohort study included all patients who underwent SAVR in Sweden between 2001 and 2018 with low surgical risk, defined as logistic EuroSCORE I <10% or EuroSCORE II <4%. Patients received a permanent pacemaker implantation within 30 days after SAVR. Main outcomes were all-cause mortality, heart failure hospitalization, and endocarditis. Regression standardization addressed confounding. Results: We included 19,576 patients with low surgical risk. Of these, 732 (3.7%) patients received a permanent pacemaker within 30 days after SAVR. The mean age was 68 years and 33% were women. We found no difference in all-cause mortality between patients who received a pacemaker compared to those who did not (absolute survival difference at 17 years: 0.1% (95% CI: -3.6% to 3.8%). After 17 years, the estimated cumulative incidence of heart failure in patients who received a pacemaker was 28% (95% CI: 24%-33%) vs 20% (95% CI: 19%-22%) in patients who did not (absolute difference 8.2% [95% CI: 3.8%-13%]). We found no difference in endocarditis between the groups. Conclusions: We found an increased incidence of heart failure in patients with low surgical risk who received a permanent pacemaker after SAVR. Permanent pacemaker implantation was not associated with all-cause mortality or endocarditis. Efforts should be made to avoid the need for permanent pacemaker following SAVR.

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.

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.

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.

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.

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.

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.

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.

Socioeconomic Status and Risk of Bleeding After Mechanical Aortic Valve Replacement.

BACKGROUND: Whether low socioeconomic status (SES) is associated with increased risk of anticoagulation-related adverse events in patients with mechanical heart valves is unknown. OBJECTIVES: This study sought to investigate the impact of patients' SES on the risk of bleeding after mechanical aortic valve replacement (AVR). METHODS: This nationwide population-based cohort study included all patients aged 18-70 years who underwent mechanical AVR in Sweden from 1997 to 2018. Data were obtained from the SWEDEHEART register and other national health data registers. The exposure was quartiles of household disposable income. The primary outcome was hospitalization for a bleeding event. RESULTS: Among 5974 patients, the absolute risk for bleeding after 20 years of follow-up was 20% (95% CI: 17%-24%) in the lowest income quartile (Q1) and 16% (95% CI: 13%-20%) in the highest quartile (Q4). The risk of bleeding decreased with increasing income level and was significantly lower in patients in income level Q3 (HR: 0.77; 95% CI: 0.60-0.99) and Q4 (HR: 0.68; 95% CI: 0.50-0.92) than Q1. The risk of death from intracranial hemorrhage was five times higher in the lowest income quartile than the age- and sex-matched general Swedish population (standardized mortality ratio: 5.0; 95% CI: 3.3-7.4). CONCLUSIONS: We observed a strong association between SES and risk of bleeding among patients who underwent mechanical AVR. These findings suggest suboptimal anticoagulation treatment in patients with lower SES and the need for strategies to optimize anticoagulation treatment in patients with a mechanical heart valve. (Health-Data Register Studies of Risk and Outcomes in Cardiac Surgery [HARTROCS]; NCT02276950).

Comparison of Long-term Performance of Bioprosthetic Aortic Valves in Sweden From 2003 to 2018.

IMPORTANCE: The performance of bioprosthetic aortic valves is usually assessed in single valve models or head-to-head comparisons. National databases or registries offer the opportunity to investigate all available valve models in the population and allows for a comparative assessment of their performance. OBJECTIVE: To analyze the long-term rates of reintervention, all-cause mortality, and heart failure hospitalization associated with commonly used bioprosthetic aortic valves and to identify valve model groups with deviation in clinical performance. DESIGN, SETTING, AND PARTICIPANTS: This population-based, nationwide cohort study included all adult patients who underwent surgical aortic valve replacement (with or without concomitant coronary artery bypass surgery or ascending aortic surgery) in Sweden between January 1, 2003, and December 31, 2018. Patients were identified from the SWEDEHEART (Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) registry. Patients with concomitant valve surgery, previous cardiac surgery, and previous transcatheter valve replacement were excluded. Follow-up was complete for all participants. Data were analyzed from March 9, 2020, to October 12, 2021. EXPOSURES: Primary surgical aortic valve replacement with the Perimount, Mosaic/Hancock, Biocor/Epic, Mitroflow/Crown, Soprano, and Trifecta valve models. MAIN OUTCOMES AND MEASURES: The primary outcome was cumulative incidence of reintervention, defined as a subsequent aortic valve operation or transcatheter valve replacement. Secondary outcomes were all-cause mortality and heart failure hospitalization. Regression standardization and flexible parametric survival models were used to account for intergroup differences. Mean follow-up time was 7.1 years, and maximum follow-up time was 16.0 years. RESULTS: A total of 16 983 patients (mean [SD] age, 72.6 [8.5] years; 10 685 men [62.9%]) were included in the analysis. The Perimount valve model group had the lowest and the Mitroflow/Crown valve model group had the highest cumulative incidence of reintervention. The estimated cumulative incidence of reintervention at 10 years was 3.6% (95% CI, 3.1%-4.2%) in the Perimount valve model group and 12.2% (95% CI, 9.8%-15.1%) in the Mitroflow/Crown valve model group. The estimated incidence of reintervention at 10 years was 9.3% (95% CI, 7.3%-11.3%) in the Soprano valve model group. CONCLUSIONS AND RELEVANCE: Results of this study showed that the Perimount valve was the most commonly used and had the lowest incidence of reintervention, all-cause mortality, and heart failure hospitalization, whereas the Mitroflow/Crown valve had the highest rates. These findings highlight the need for clinical vigilance in patients who receive either a Soprano or Mitroflow/Crown aortic bioprosthesis.

Sex and Permanent Pacemaker Implantation After Surgical Aortic Valve Replacement.

BACKGROUND: We performed a nationwide population-based cohort study to investigate sex differences in the rate of permanent pacemaker implantation after surgical aortic valve replacement (AVR). METHODS: This study included all adult patients who underwent primary AVR in Sweden between 2005 and 2018. Study data were obtained from the Swedish Web system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART) registry and other Swedish national health-data registers. The rate of permanent pacemaker implantation within 30 days of surgery AVR was compared between men and women. We estimated propensity scores that were used for inverse probability of treatment weighting to account for sex differences in patient characteristics. RESULTS: A total of 18 131 patients were included, 11 657 men (64%) and 6474 women (36%). The rate of permanent pacemaker implantation did not differ between women (3.8%; 95% CI, 3.2%-4.3%) and men (3.7%; 95% CI, 3.3%-4.1%; P = .831). In patients aged <60 years, the rate of permanent pacemaker implantation was significantly higher in women (6.2%; 95% CI, 4.3%-8.0%) than in men (3.6%; 95% CI, 2.8%-4.4%; P = .006). The odds of pacemaker implantation in patients aged <60 years was significantly higher in women (odds ratio, 1.76; 95% CI, 1.17-2.63; P = .006). In patients aged 60 to 79 years and ≥80 years, the rate of pacemaker implantation did not differ between men and women. CONCLUSIONS: The rate of permanent pacemaker implantation after surgical AVR in patients aged <60 years was higher in women than in men. The susceptibility to conduction disturbances requiring permanent pacemaker implantation in women aged <60 years warrants further investigation and should be recognized as transcatheter aortic valve replacement expands into younger patients.

Survival after aortic root replacement with a stentless xenograft is determined by patient characteristics.

OBJECTIVES: Our objective was to examine intermediate-term survival and reinterventions in unselected patients, stratified according to indication, who received a Freestyle (Medtronic Inc, Minneapolis, Minn) bioprosthesis as a full aortic root replacement. METHODS: Data from medical records were retrospectively collected for patients who had aortic root replacement using Freestyle bioprostheses between 1999 and 2018 at 6 North-Atlantic centers. Survival status was extracted from national registries and results stratified according to indication for surgery. RESULTS: We included 1030 implantations in 1008 patients with elective indications for surgery: aneurysm (39.8%), small root (8.3%), and other (13.8%), and urgent/emergent indications: endocarditis (26.7%) and Stanford type A aortic dissection (11.4%). Across indications, 46.3% were nonelective cases and 34.0% were reoperations. Median age was 66.0 (interquartile range, 58.0-71.8) years and median follow-up was 5.0 (interquartile range, 2.6-7.9) years. Thirty-day mortality varied from 2.9% to 27.4% depending on indication. Intermediate survival for 90-day survivors with elective indications were not different from the general population standardized for age and sex (P = .95, .83, and .16 for aneurysms, small roots, and other, respectively). In contrast, patients with endocarditis and type A dissection had excess mortality (P < .001). Freedom from valve reinterventions was 95.0% and 94.4% at 5 and 8 years, respectively. In all, 52 patients (5.2%) underwent reinterventions, most because of endocarditis. CONCLUSIONS: At intermediate term follow-up this retrospective study provides further support for the use of the Freestyle bioprosthesis in the real-world setting of diverse, complex, and often high-risk aortic root replacement and suggests that outcome is determined by patient and disease, rather than by prosthesis, characteristics.