Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 35
Filter
1.
JAMA Netw Open ; 7(4): e247525, 2024 Apr 01.
Article in English | MEDLINE | ID: mdl-38639933

ABSTRACT

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.


Subject(s)
Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Male , Humans , Middle Aged , Aortic Valve/surgery , Cohort Studies , Prosthesis Design
2.
J Am Heart Assoc ; 13(1): e031387, 2024 Jan 02.
Article in English | MEDLINE | ID: mdl-38156596

ABSTRACT

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.


Subject(s)
Bioprosthesis , Endocarditis, Bacterial , Endocarditis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Male , Humans , Animals , Cattle , Swine , Aged , Female , Aortic Valve/surgery , Heart Valve Prosthesis/adverse effects , Bioprosthesis/adverse effects , Endocarditis, Bacterial/surgery , Cohort Studies , Endocarditis/epidemiology , Endocarditis/etiology , Heart Valve Prosthesis Implantation/methods
4.
J Am Coll Cardiol ; 81(10): 964-975, 2023 03 14.
Article in English | MEDLINE | ID: mdl-36889875

ABSTRACT

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.


Subject(s)
Aortic Valve Stenosis , Heart Failure , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Humans , Aortic Valve/surgery , Heart Valve Prosthesis Implantation/adverse effects , Cohort Studies , Aortic Valve Stenosis/surgery , Treatment Outcome , Heart Valve Prosthesis/adverse effects , Heart Failure/epidemiology , Heart Failure/surgery , Risk Factors , Prosthesis Design
6.
Ann Cardiothorac Surg ; 11(4): 448-458, 2022 Jul.
Article in English | MEDLINE | ID: mdl-35958533

ABSTRACT

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.

8.
J Am Coll Cardiol ; 79(25): 2502-2513, 2022 06 28.
Article in English | MEDLINE | ID: mdl-35738711

ABSTRACT

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).


Subject(s)
Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Anticoagulants/adverse effects , Aortic Valve/surgery , Cohort Studies , Heart Valve Prosthesis Implantation/adverse effects , Hemorrhage/epidemiology , Hemorrhage/etiology , Humans , Social Class , Treatment Outcome
10.
JAMA Netw Open ; 5(3): e220962, 2022 Mar 01.
Article in English | MEDLINE | ID: mdl-35254431

ABSTRACT

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.


Subject(s)
Aortic Valve , Heart Failure , Aged , Aortic Valve/surgery , Cohort Studies , Female , Humans , Male , Prosthesis Design , Sweden/epidemiology
12.
Ann Thorac Surg ; 114(5): 1621-1627, 2022 11.
Article in English | MEDLINE | ID: mdl-34648811

ABSTRACT

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.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Pacemaker, Artificial , Transcatheter Aortic Valve Replacement , Female , Humans , Male , Aortic Valve/surgery , Cohort Studies , Risk Factors , Aortic Valve Stenosis/surgery , Treatment Outcome , Retrospective Studies
13.
J Thorac Cardiovasc Surg ; 164(6): 1712-1724.e10, 2022 12.
Article in English | MEDLINE | ID: mdl-34452760

ABSTRACT

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.


Subject(s)
Bioprosthesis , Endocarditis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Humans , Aged , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Heart Valve Prosthesis Implantation/methods , Retrospective Studies , Heterografts , Prosthesis Design , Treatment Outcome , Endocarditis/surgery , Follow-Up Studies
15.
BMJ Open ; 11(11): e047962, 2021 11 18.
Article in English | MEDLINE | ID: mdl-34794986

ABSTRACT

OBJECTIVE: Bioprosthetic aortic valves with an extended subannular component, such as transcatheter valves, exert increased compression on the cardiac conduction system and increase the risk for permanent pacemaker implantation. It is unknown if the On-X mechanical prosthetic valve, which has an elongated subannular valve housing, increases the risk of permanent pacemaker implantation following aortic valve replacement. DESIGN: Observational nationwide cohort study. SETTING: Swedish population-based study. PARTICIPANTS: All patients aged 18-65 years who underwent primary mechanical aortic valve replacement in Sweden between 2005 and 2018. We used the Swedish Web system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies register and other Swedish national health-data registers. EXPOSURE: Patients implanted with an On-X valve versus patients implanted with other bileaflet mechanical valves. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome measure was permanent pacemaker implantation within 30 days of surgery. RESULTS: A total of 2602 patients were included, and 581 patients received an On-X valve and 2021 patients received a St Jude Masters/Regent (n=945) or Carbomedics Reduced valve (n=1076). In the total study population, 115 (4.4%) permanent pacemaker implantations were performed within 30 days after aortic valve replacement. In the propensity score matched population, there was no significant difference in the rate of permanent pacemaker implantation in the On-X group compared with the control group: 3.6% (95% CI: 2.4% to 5.5%) vs 4.0% (95% CI: 2.7% to 5.9%), p=0.877. CONCLUSIONS: The On-X prosthetic heart valve was associated with a similarly low risk for permanent pacemaker implantation after aortic valve replacement compared with other conventional bileaflet mechanical valves. The On-X elongated subannular valve housing does not interfere with the cardiac conduction system.


Subject(s)
Aortic Valve Stenosis , Pacemaker, Artificial , Transcatheter Aortic Valve Replacement , Aortic Valve/surgery , Aortic Valve Stenosis/surgery , Cohort Studies , Humans , Retrospective Studies , Risk Factors , Treatment Outcome
16.
J Am Heart Assoc ; 10(22): e022627, 2021 11 16.
Article in English | MEDLINE | ID: mdl-34743549

ABSTRACT

Background Prior studies showed that life expectancy in patients who underwent surgical aortic valve replacement (AVR) was lower than in the general population. Explanations for this shorter life expectancy are unknown. The aim of this nationwide, observational cohort study was to investigate the cause-specific death following surgical AVR. Methods and Results We included 33 018 patients who underwent primary surgical AVR in Sweden between 1997 and 2018, with or without coronary artery bypass grafting. The SWEDEHEART (Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) register and other national health-data registers were used to obtain and characterize the study cohort and to identify causes of death, categorized as cardiovascular mortality, cancer mortality, or other causes of death. The relative risks for cause-specific mortality in patients who underwent AVR compared with the general population are presented as standardized mortality ratios. During a mean follow-up period of 7.3 years (maximum 22.0 years), 14 237 (43%) patients died. The cumulative incidence of death from cardiovascular, cancer-related, or other causes was 23.5%, 8.3%, and 11.6%, respectively, at 10 years, and 42.8%, 12.8%, and 23.8%, respectively, at 20 years. Standardized mortality ratios for cardiovascular, cancer-related, and other causes of death were 1.79 (95% CI, 1.75-1.83), 1.00 (95% CI, 0.97-1.04), and 1.08 (95% CI, 1.05-1.12), respectively. Conclusions We found that life expectancy following AVR was lower than in the general population. Lower survival after AVR was explained by an increased relative risk of cardiovascular death. Future studies should focus on the role of earlier surgery in patients with asymptomatic aortic stenosis and on optimizing treatment and follow-up after AVR. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02276950.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Neoplasms , Aortic Valve/surgery , Aortic Valve Stenosis/surgery , Cause of Death , Heart Valve Prosthesis Implantation/adverse effects , Humans , Retrospective Studies , Risk Factors , Treatment Outcome
17.
Open Heart ; 8(2)2021 10.
Article in English | MEDLINE | ID: mdl-34642241

ABSTRACT

BACKGROUND: Small femoral arteries have been associated with a higher risk of vascular complications in transfemoral transcatheter aortic valve replacement (TAVR). We investigated the feasibility and safety of TAVR in patients with small femoral arteries. METHODS: In this observational study, we included 82 patients who underwent transfemoral TAVR with the ACURATE neo system using the expandable 14F iSleeve sheath between 2018 and 2019 at Karolinska University Hospital, Sweden. Of these, 41 patients had a minimal femoral artery diameter of ≥5.5 mm (mean 6.5, range 5.5-9.2), and 41 patients had a minimal femoral artery diameter <5.5 mm (mean 4.9, range 3.9-5.4). RESULTS: There was no significant difference in major vascular and bleeding complications between the small femoral artery group (7%) and the normal femoral artery group (2%) (p=0.62). The total of major and minor vascular complications did not differ significantly according to femoral artery size (17% vs 5%) (p=0.16). The iSleeve sheath was not correlated with any of the complications. The use of the iSleeve sheath was unsuccessful in four patients (5%), of which one patient had a small femoral artery diameter. CONCLUSION: Transfemoral TAVR with the ACURATE neo system using the iSleeve sheath is a promising method for patients with small femoral arteries even though we found a trend towards higher rates of complications in these patients. The use of expandable sheaths may expand the spectrum of patients that can be treated with transfemoral TAVR, and thus may improve the prognosis in patients with severe aortic valve stenosis.


Subject(s)
Angiography/methods , Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Femoral Artery/diagnostic imaging , Transcatheter Aortic Valve Replacement/instrumentation , Aged , Aged, 80 and over , Aortic Valve Stenosis/diagnosis , Cardiac Catheterization/instrumentation , Equipment Design , Feasibility Studies , Female , Femoral Artery/surgery , Follow-Up Studies , Humans , Male , Retrospective Studies , Risk Factors
18.
JACC Cardiovasc Interv ; 14(19): 2173-2181, 2021 10 11.
Article in English | MEDLINE | ID: mdl-34620397

ABSTRACT

OBJECTIVES: This study was performed to investigate long-term, clinically important outcomes in patients who underwent permanent pacemaker implantation after transcatheter aortic valve replacement (TAVR). BACKGROUND: The impact of permanent pacemaker implantation after TAVR is unknown, and prior studies have produced conflicting results. METHODS: In this nationwide, population-based cohort study, the study included all patients who underwent transfemoral TAVR in Sweden from 2008 to 2018 from the SWEDEHEART (Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies) register. Additional baseline characteristics and information about outcomes were obtained by individual crosslinking with other national health data registers. Unadjusted and multivariable-adjusted analyses were performed using Cox proportional hazards regression. RESULTS: Of 3,420 patients, 481 (14.1%) underwent permanent pacemaker implantation within 30 days after TAVR. The survival rate at 1, 5, and 10 years was 90.0%, 52.7%, and 10.9% in the pacemaker group and 92.7%, 53.8%, and 15.3% in the nonpacemaker group, respectively (HR: 1.03; 95% CI: 0.88-1.22; P = 0.692). The median follow-up was 2.7 years (interquartile range: 2.5, and maximum 11.8 years). There was no difference in the risk of cardiovascular death (HR: 0.91; 95% CI: 0.71-1.18; P = 0.611), heart failure (HR: 1.23; 95% CI: 0.92-1.63; P = 0.157), or endocarditis (HR: 0.90; 95% CI: 0.47-1.69; P = 0.734) between the groups. CONCLUSIONS: The study found no difference in long-term survival between patients who did and did not undergo permanent pacemaker implantation after TAVR. As the use of TAVR expands to include younger and low-risk patients with a long life expectancy, it will become increasingly important to understand the impact of permanent pacemaker implantation after TAVR.


Subject(s)
Aortic Valve Stenosis , Pacemaker, Artificial , Transcatheter Aortic Valve Replacement , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Cardiac Pacing, Artificial , Cohort Studies , Humans , Retrospective Studies , Risk Factors , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
19.
JAMA Netw Open ; 4(7): e2116564, 2021 07 01.
Article in English | MEDLINE | ID: mdl-34255050

ABSTRACT

Importance: Prior studies investigating the long-term clinical outcomes of patients who have undergone permanent pacemaker implantation after aortic valve replacement reported conflicting results. Objective: To investigate long-term outcomes after primary surgical aortic valve replacement among patients who underwent postoperative permanent pacemaker implantation. Design, Setting, and Participants: This cohort study included all patients who underwent surgical aortic valve replacement in Sweden from 1997 to 2018. All patients who underwent primary surgical aortic valve replacement in Sweden and survived the first 30 days after surgical treatment were included. Patients who underwent preoperative permanent pacemaker implantation, concomitant surgical treatment for another valve, or emergency surgical treatment were excluded. Patients who underwent concomitant coronary artery bypass grafting or surgical treatment of the ascending aorta were included. Follow-up data were complete for all patients. Data were analyzed from October through December 2020. Exposures: Patients underwent implantation of a permanent pacemaker or implantable cardioverter defibrillator within 30 days after aortic valve replacement. Main Outcomes and Measures: The primary outcome was all-cause mortality. Results: Among 24 983 patients who underwent surgical aortic valve replacement, 849 patients (3.4%) underwent permanent pacemaker implantation within 30 days after surgical treatment and 24 134 patients (96.6%) did not receive pacemakers in that time. The mean (SD) age of the total study population was 69.7 (10.8) years, and 9209 patients were women (36.9%). The mean (SD) and maximum follow-up periods were 7.3 (5.0) years and 22.0 years, respectively. At 10 years and 20 years after surgical treatment, the Kaplan-Meier estimated survival rates were 52.8% and 18.0% in the pacemaker group, respectively, and 57.5% and 19.6% in the nonpacemaker group, respectively. All-cause mortality was statistically significantly increased in the pacemaker group compared with the nonpacemaker group (hazard ratio [HR], 1.14; 95% CI, 1.01-1.29; P = .03), and so was risk of heart failure hospitalization (HR, 1.58; 95% CI, 1.31-1.89; P < .001). No statistically significant increase was found in the risk of endocarditis in the pacemaker group. Conclusions and Relevance: This study found that there were increased risks of all-cause mortality and heart failure hospitalization among patients who underwent permanent pacemaker implantation after surgical aortic valve replacement, suggesting that these risks are important considerations, especially in an era when transcatheter aortic valve replacement is used in younger patients at lower risk of adverse surgical outcomes. These findings further suggest that future research should investigate how to avoid permanent pacemaker dependency after surgical and transcatheter aortic valve replacement.


Subject(s)
Defibrillators, Implantable/statistics & numerical data , Pacemaker, Artificial/statistics & numerical data , Postoperative Complications/surgery , Prosthesis Implantation/mortality , Transcatheter Aortic Valve Replacement/adverse effects , Aged , Aorta/surgery , Coronary Artery Bypass/adverse effects , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Postoperative Complications/etiology , Postoperative Period , Prosthesis Implantation/instrumentation , Survival Rate , Sweden , Treatment Outcome
20.
Heart ; 107(14): 1167-1172, 2021 07.
Article in English | MEDLINE | ID: mdl-33622679

ABSTRACT

OBJECTIVES: The objective of this cohort study was to analyse long-term relative survival in patients with bicuspid aortic valve (BAV) who underwent aortic valve surgery. METHODS: We studied 865 patients with BAVs who participated in three prospective cohort studies of elective, open-heart, aortic valve surgery at the Karolinska University Hospital, Stockholm, Sweden, between 2007 and 2020. The expected survival for the age, sex and calendar year-matched general Swedish population was obtained from the Human Mortality Database. The Ederer II method was used to calculate relative survival, which was used as an estimate of cause-specific survival. RESULTS: No differences were found in the observed versus expected survival at 1, 5, 10 or 12 years: 99%, 94%, 83% and 76% vs 99%, 93%, 84% and 80%, respectively. The relative survival at 1, 5, 10 and 12 years was 100% (95% CI 99% to 100%), 101% (95% CI 99% to 103%), 99% (95% CI 95% to 103%) and 95% (95% CI 87% to 102%), respectively. The relative survival at the end of follow-up tended to be lower for women than men (86% vs 95%). The mean follow-up was 6.3 years (maximum 13.3 years). CONCLUSIONS: The survival of patients with BAV following aortic valve surgery was excellent and similar to that of the general population. Our results suggest that the timing of surgery according to current guidelines is correct and provide robust long-term survival rates, as well as important information about the natural history of BAV in patients following aortic valve surgery.


Subject(s)
Aortic Valve , Bicuspid Aortic Valve Disease , Heart Valve Prosthesis Implantation , Long Term Adverse Effects , Adult , Aortic Valve/abnormalities , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Bicuspid Aortic Valve Disease/diagnosis , Bicuspid Aortic Valve Disease/epidemiology , Bicuspid Aortic Valve Disease/physiopathology , Bicuspid Aortic Valve Disease/surgery , Cohort Studies , Female , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis Implantation/statistics & numerical data , Humans , Kaplan-Meier Estimate , Long Term Adverse Effects/diagnosis , Long Term Adverse Effects/etiology , Long Term Adverse Effects/mortality , Male , Outcome Assessment, Health Care , Prospective Studies , Sex Factors , Sweden/epidemiology
SELECTION OF CITATIONS
SEARCH DETAIL
...