First-time surgical aortic valve replacement: nationwide trends and outcomes from The Netherlands Heart Registration.

OBJECTIVES: The aim of this study was to describe trends and outcomes for patients undergoing surgical aortic valve replacement (SAVR) in the Netherlands. METHODS: The Netherlands Heart Registration database was used to report the number and outcomes of isolated, primary SAVR procedures performed from 2007 to 2018 in adult patients. RESULTS: A total of 17 142 procedures were included, of which 77.9% were performed using a biological prosthesis and 21.0% with a mechanical prosthesis. Median logistic EuroSCORE I decreased from 4.6 [interquartile range (IQR) 2.4-7.7] to 4.0 (IQR 2.6-6.0). The 120-day mortality decreased from 3.3% in 2007 to 0.7% in 2018. The median duration of follow-up was 76 months (IQR 53-111). Ten-year survival, when adjusted for age, EuroSCORE I and body surface area, was 72.4%, and adjusted 10-year freedom from reinvervention was 98.1%. Additional analysis for patients under the age of 60 showed no difference between patients treated with a biological or mechanical prosthesis in adjusted 10-year survival, 89.7% vs 91.9±%, respectively (P = 0.25), but a significant difference in adjusted 10-year freedom from reintervention, 90.0±% vs 95.9%, respectively (P < 0.01). CONCLUSIONS: Between 2007 and 2018, age and risk profile of patients undergoing SAVR decreased, especially for patients treated with a biological prosthesis. The 120-day mortality decreased over time. Patients undergoing SAVR nowadays have a risk of 120-day mortality of <1% and 10-year freedom from valve-related reintervention of >95%.

Patterns of aortic valve replacement in Europe and adoption by sex.

OBJECTIVE: Management of patients with severe aortic stenosis (AS) may differ according to the patient sex. This study aimed to describe patterns of aortic valve replacement (AVR) for severe AS across Europe, including stratification by sex. METHODS: Procedure volume data for surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) for six years (2015-2020) were extracted from national databases for Austria, Czech Republic, Denmark, England, Finland, France, Germany, Norway, Poland, Spain, Sweden, and Switzerland and stratified by sex. Patients per million population (PPM) undergoing AVR per year were calculated using population estimates from Eurostat. RESULTS: Between 2015 and 2019, AVR procedures grew at an average annual rate of 3.9%. In 2020, the average total PPM undergoing AVR across all countries was 339, with 51% of procedures being TAVI and 49% SAVR. AVR PPM varied widely between countries, with the highest and lowest in Germany and Poland, respectively. The average total PPM was higher for men than women (423 vs. 258), but a higher proportion of women (62%) than men (44%) received TAVI. The proportion of TAVI among total AVR procedures increased with age, with an overall average of 96% of men and 98% of women aged ≥85 years receiving TAVI; however, adoption of TAVI varied by country. CONCLUSIONS: The analysis of temporal trends in the adoption of TAVI vs. SAVR across Europe showed significant variations. Despite the higher use of TAVI vs. SAVR in women, overall rates of AV intervention in women were lower compared to men.

Travel distance and outcomes after surgical aortic valve among veterans.

OBJECTIVE: To investigate the association between travel distance and postoperative length of stay (LOS) and discharge disposition among veterans undergoing surgical aortic valve replacement (SAVR). DATA SOURCES/STUDY SETTING: We performed a retrospective cohort study of patients undergoing SAVR, with or without coronary artery bypass grafting (CABG) at VA Boston Healthcare (January 1, 2005-December 31, 2015). STUDY DESIGN: Postoperative LOS and discharge disposition were compared for SAVR patients based on travel distance to the facility: <100 miles or ≥100 miles. Multivariable regression was performed to ascertain factors associated with LOS and home discharge. DATA COLLECTION/EXTRACTION METHODS: Data were collected via chart review. All patients undergoing SAVR at our institution who primarily resided within the defined region were included. PRINCIPAL FINDINGS: Of 597 patients studied, 327 patients underwent isolated SAVR; 270 patients underwent SAVR/CABG. Overall median (IQR) distance between the patient's residence and the hospital was 49.95 miles (27.41-129.94 miles); 190 patients (32%) resided further than 100 miles away. There were no differences in the proportion of patients with diabetes, hypertension, chronic obstructive pulmonary disease (COPD), cerebrovascular disease, atrial fibrillation, or prior myocardial infarction between groups. Overall LOS (IQR) was 9 (7-13) days and did not differ between groups (p = 0.18). The proportion of patients discharged home was higher among patients who resided more than 100 miles from the hospital (71% vs. 58%, p = 0.01). On multivariable analysis, residing further than 100 miles from the hospital was independently associated with home discharge (OR = 1.64, 95% CI: 1.09-2.48). Travel distance was not associated with LOS. CONCLUSIONS: Based on our institutional experience, potential concerns of longer hospital stay or discharge to other inpatient facilities for geographically distanced patients undergoing SAVR do not appear supported. Continued examination of the drivers underlying the marked shift of veterans to the private sector appears warranted.

Urgent versus elective surgical disparities among American Indian and Alaska Native patients.

BACKGROUND: American Indian and Alaska Native (AIAN) health issues are understudied despite documentation of lower-than-average life expectancy. Urgent surgery is associated with higher rates of postsurgical complications and postoperative death. We assess whether American Indian and Alaska Native (AIAN) patients in Washington State are at greater risk of requiring urgent rather than elective surgery compared with non-Hispanic Whites (NHW). METHODS: We accessed data for the period 2009-2014 from the Washington State Comprehensive Hospital Abstract Reporting System (CHARS) database, which captures all statewide hospital admissions, to examine three common surgeries that are performed both urgently and electively: hip replacements, aortic valve replacements, and spinal fusions. We extracted patient race, age, insurance status, comorbidity, admission type, and procedures performed. We then constructed multivariable logistic regression models to identify factors associated with use of urgent surgical care. RESULTS: AIAN patients had lower mean age at surgery for all three surgeries compared with NHW patients. AIAN patients were at higher risk for urgent surgery for hip replacements (OR = 1.49, 95% CI 1.19-1.88), spinal fusions (OR = 1.39, 95% CI 1.04-1.87), and aortic valve replacements (OR = 2.06, 95% CI 1.12-3.80). CONCLUSION: AIAN patients were more likely to undergo urgent hip replacement, spinal fusion, and aortic valve replacement than NHW patients. AIAN patients underwent urgent surgery at younger ages. Medicaid insurance conferred higher risks for urgent surgery across all surgeries studied. Further research is warranted to more clearly identify the factors contributing to disparities among AIAN patients undergoing urgent surgery.

Adipokines are possible risk markers for aortic stenosis requiring surgery.

OBJECTIVES: Aortic stenosis (AS) is the most prevalent valvular heart disease among adults. The adipocyte-derived hormones, leptin and adiponectin, have profound metabolic actions. We examined whether these adipokines are independently associated with future aortic valve replacement (AVR). DESIGN: In this longitudinal case-control study, we identified 336 cases who had undergone AVR due to AS, and who had previously participated in population-based health surveys. Two referents were matched to each case and leptin and adiponectin concentrations were analysed from stored baseline survey samples. Uni- and multivariable logistic regression analyses were used to estimate the risk of future AVR. An additional cohort was identified for validation including 106 cases with AVR and 212 matched referents. RESULTS: Median age (interquartile range (IQR)) in years at survey was 59.9 (10.4) and at surgery 68.3 (12.7), and 48% were women. An elevated concentration of leptin was not associated with future AVR (odds ratio [95% confidence interval]) (1.10 [0.92-1.32]), although leptin was associated with a higher risk in patients with coronary artery disease (CAD) having more than 5 years between survey and AVR (1.41 [1.08-1.84]). Adiponectin was not associated with higher risk for future AVR (0.95 [0.82-1.11]), although after stratification for age, higher levels were associated with reduced risk for AVR in persons aged ≥60 years at surgery (0.79 [0.64-0.98]). In the validation study, leptin was associated with future AVR whereas adiponectin was not. None of the associations remained significant after adjustment for body mass index (BMI). CONCLUSIONS: The adipokine leptin may promote the development of AS.

Recent improvement in operative techniques lead to lower pacemaker rate after Perceval implant.

OBJECTIVES: Our goal was to compare pacemaker rate usage following two different operating techniques for implanting the Perceval aortic valve replacement. METHODS: In this retrospective, single-centre study, we studied patients with isolated or concomitant Perceval aortic valve replacement operated on first between April 2013 and January 2016, following traditional operating techniques, with patients operated on between January 2016 and December 2020, after the adoption of a modified protocol based on different annulus sizing, higher positioning of the valve and no ballooning after valve deployment was adopted. The operations were performed by 2 surgeons, and patients were followed-up for a period of 30 days. RESULTS: A total of 286 patients, with a mean age of 77 (4.9) years, had Perceval valves implanted during the study period, of which 79% were isolated aortic valve procedures. Most patients (66.8%) underwent minimally invasive procedures. Cross-clamp time was 55.1 (17.6) min. The overall postoperative pacemaker insertion rate was 8.4%, which decreased decisively after the 2016 change in the implant protocol (16% vs 5.6%; P = 0.005), adjusted odds ratio of 0.31 (95% confidence interval: 0.13-0.74, P = 0.012). Univariable and multivariable analysis showed that larger valve size (P = 0.01) and ballooning (P = 0.002) were associated with higher risk of implanting a pacemaker. Postoperative 30-day mortality was of 4.5%. CONCLUSIONS: Improvement in the operating techniques for implanting the Perceval valve may decrease the rate of pacemakers implanted postoperatively. Although further studies are needed to confirm these results, such a risk reduction may lead to wider use of Perceval valves in the future, potentially benefiting patients who are suitable candidates for minimally invasive surgery.

Transcatheter Edge-to-Edge Repair in COAPT-Ineligible Patients: Incidence and Predictors of 2-Year Good Outcome.

BACKGROUND: COAPT-trial entry criteria are useful to identify patients with better outcomes after transcatheter edge-to-edge repair (TEER). However, up to one-half of real-world patients with secondary mitral regurgitation (SMR) undergoing TEER do not meet these highly selective criteria and no study has formally investigated them. The aim of this study was to evaluate the predictors of good outcome after TEER in COAPT-ineligible patients. METHODS: All consecutive patients with SMR and heart failure (HF) treated with MitraClip at 3 European centres were retrospectively screened. The presence of at least 1 COAPT exclusion criterion was used to define a COAPT-ineligible profile, allowing the inclusion in the study population. Freedom from all-cause death or HF hospitalisation was evaluated at 2-year follow-up (primary end point). RESULTS: A total of 305 patients (47%) had a COAPT-ineligible profile. An overall 58% rate of all-cause death or HF hospitalisation was detected at 2 years. Patients with a single COAPT exclusion criterion experienced fewer adverse events than those with multiple criteria (55% vs 69%). At multivariable Cox regression analysis, New York Heart Association functional class II, younger age (< 75 years), lower serum creatinine (< 2 mg/dL), lower left ventricular end-diastolic volume (< 240 mL), and the absence of hemodynamic instability, atrial fibrillation, and chronic obstructive pulmonary disease were independently associated with good outcome. CONCLUSIONS: In this real-world series of patients with SMR undergoing TEER, a COAPT-ineligible profile was common. The presence of only 1 COAPT exclusion criterion or the absence of hemodynamic instability were associated with the most favourable outcomes.

Epidemiology of Aortic Stenosis/Aortic Valve Replacement (from the Nationwide Swedish Renal Registry).

Contemporary data on the prevalence and incidence of aortic stenosis (AS) and aortic valve replacement (AVR) in patients initiating dialysis are scarce. This observational cohort study aimed to estimate (1) the point prevalence of AS and AVR at dialysis start and (2) the AS incidence and associated factors prospective to dialysis initiation. The study included 14,550 patients initiating dialysis registered in the Swedish Renal Registry between 2005 and 2018. AS was defined by the International Statistical Classification of Diseases, Tenth Revision codes, and AVR by the surgical procedure codes. Associations between covariates and outcomes were assessed in Cox regression models. The median age was 68 (57 to 77), 66% were males, and the point prevalence of AS and AVR was 3.4% and 1.1%, respectively. In those without known AS/AVR at dialysis initiation (n = 14,050), AS was diagnosed in 595 patients (incidence 16.3/1000 person-years, 95% confidence interval [CI] 15.1 to 17.7/1,000 person-years) during a median follow-up of 2.7 years (interquartile range 1.1 to 5.7). In adjusted Cox regression models, higher age (hazard ratio [HR] 1.03, 95% CI 1.02 to 1.04), male gender (HR 1.51, 95% CI 1.25 to 1.83), atrial fibrillation (HR 1.32, 95% CI 1.06 to 1.64), and hypertension (HR 1.65, 95% CI 1.03 to 2.65) were associated with incident AS. Peritoneal dialysis patients had a nonsignificant trend toward higher AS risk compared with hemodialysis (HR 1.18, 95% CI 0.99 to 1.40). About 20% of patients (n = 113) diagnosed with incident AS underwent AVR (incidence 3.1/1000 person-years, 95% CI 2.6 to 3.7/1,000). Only the male gender was associated with AVR (HR 2.07, 95% CI 1.30 to 3.30). In conclusion, the prevalence and incidence of AS and AVR in patients initiating dialysis are high. A fifth of newly diagnosed AS underwent AVR after dialysis onset.

Revascularization strategies in patients with infective endocarditis-related ST-elevation myocardial infarction: The STEMI-ENDO Registry.

OBJECTIVE: Infective endocarditis (IE)-related ST elevation myocardial infarction (STEMI) is extremely rare. A clear clinical consensus is lacking regarding the management of this emergency. In this study, we aimed to describe the clinical outcomes of treatment strategies in this patient population. METHODS: The study population comprised 19 retrospectively evaluated patients (nine women; mean age 52±11.8 years) with a diagnosis of IE-related STEMI. Transesophageal echocardiography detected vegetation in all the patients. The study population was divided into two groups on the basis of in-hospital mortality. RESULTS: Major clinical manifestations included dyspnea (89.5%), fever (78.9%), and chest pain (63.2%). Catheter-based coronary angiography was performed in all the patients. The causative agent was isolated in all the cases, and Staphylococcus aureus was identified in seven (36.8%). The most common infarction was in the left anterior descending artery (n=12 [63.2%]). The treatment strategy consisted of mechanical thrombectomy (n=1), valve replacement following stent implantation (n=5), direct balloon angioplasty (n=4), valve replacement along with coronary artery bypass grafting (CABG; n=6), and medical follow-up (n=3). Moreover, thrombolysis in myocardial infarction III flow was significantly higher in the survival group (100% vs. 0%, p<0.001). All these patients preferred CABG or stent implantation for revascularization. CONCLUSION: The current data suggest that a revascularization strategy with stent implantation or revascularization with CABG has a lower mortality rate in patients with IE-related STEMI.

Transcatheter Mitral Valve Therapy in the United States: A Report From the STS-ACC TVT Registry.

Data for nearly all patients undergoing transcatheter edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR) with an approved device in the United States is captured in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. All data submitted for TEER or TMVR between 2014 and March 31, 2020, are reported. A total of 37,475 patients underwent a mitral transcatheter procedure, including 33,878 TEER and 3,597 TMVR. Annual procedure volumes for TEER have increased from 1,152 per year in 2014 to 10,460 per year in 2019 at 403 sites and for TMVR from 84 per year to 1,120 per year at 301 centers. Mortality rates have decreased for TEER at 30 days (5.6%-4.1%) and 1 year (27.4%-22.0%). Early off-label use data on TMVR in mitral valve-in-valve therapy led to approval by the U.S. Food and Drug Administration in 2017, and the 2019 30-day mortality rate was 3.9%. Overall improvements in outcomes over the last 6 years are apparent. (STS/ACC TVT Registry Mitral Module; NCT02245763).

Adults With Tetralogy of Fallot: Early Postoperative Outcomes and Risk Factors for Complications.

OBJECTIVE: To report the early postoperative outcomes in adults with tetralogy of Fallot (TOF) undergoing cardiac surgery and to identify patient factors associated with complications. PATIENTS AND METHODS: We performed a single-institution retrospective review of adults with TOF who underwent cardiac surgery from January 8, 2008, through June 21, 2018. Patients' characteristics, preoperative imaging, surgical interventions, outcomes, and complications were analyzed. RESULTS: There were 219 adults with TOF (mean age, 40 years; range, 18-83 years; 88 [40%] female) in the study. Surgical interventions included repair or replacement of the pulmonary valve (n=199 [91%]), tricuspid valve (n=70 [32%]), mitral valve (n=13 [5.9%]), and aortic valve (n=8 [3.7%]). Three patients (1.4%) underwent first-time TOF repair. The 30-day mortality rate was 1.4% (n=3). Early postoperative complications occurred in 66 (30%) and included arrhythmias requiring treatment, dialysis requirement, liver dysfunction, respiratory failure, infection, reoperation, cardiac arrest, mechanical circulatory support, and death. Multivariate analysis found older age at current surgery (odds ratio [OR], 1.04 per year; 95% CI, 1.01 to 1.06; P<.001), longer cardiopulmonary bypass time (OR, 1.01 per minute; 95% CI, 1.01 to 1.02; P<.001), right ventricular systolic dysfunction (OR, 1.31; 95%, CI 1.02 to 1.69; P=.03), diabetes mellitus (OR, 3.50; 95% CI, 1.20 to 10.2; P=.02), and history of initial palliative surgery (OR, 1.99; 95% CI, 1.01 to 3.91; P=.05) as independent predictors of complications. CONCLUSION: Surgical interventions for adult patients with TOF can be performed with low early morbidity and mortality. Clinical characteristics and preoperative testing parameters can predict risk for complications in the postoperative period.

Multicenter Study of Endocarditis After Transcatheter Pulmonary Valve Replacement.

BACKGROUND: Endocarditis has emerged as one of the most impactful adverse events after transcatheter pulmonary valve replacement (TPVR), but there is limited information about risk factors for and outcomes of this complication. OBJECTIVES: The purpose of this study was to evaluate risk factors for and outcomes of endocarditis in a large multicenter cohort. METHODS: The authors established an international registry focused on characterizing endocarditis after TPVR, including the incidence, risk factors, characteristics, and outcomes. RESULTS: Investigators submitted data for 2,476 patients who underwent TPVR between July 2005 and March 2020 and were followed for 8,475 patient-years. In total, 182 patients were diagnosed with endocarditis a median of 2.7 years after TPVR, for a cumulative incidence of 9.5% (95% CI: 7.9%-11.1%) at 5 years and 16.9% (95% CI: 14.2%-19.8%) at 8 years (accounting for competing risks: death, heart transplant, and explant) and an annualized incidence of 2.2 per 100 patient-years. Staphylococcus aureus and Viridans group Streptococcus species together accounted for 56% of cases. Multivariable analysis confirmed that younger age, a previous history of endocarditis, and a higher residual gradient were risk factors for endocarditis, but transcatheter pulmonary valve type was not. Overall, right ventricular outflow tract (RVOT) reintervention was less often to treat endocarditis than for other reasons, but valve explant was more often caused by endocarditis. Endocarditis was severe in 44% of patients, and 12 patients (6.6%) died, nearly all of whom were infected with Staphylococcus aureus. CONCLUSIONS: The incidence of endocarditis in this multicenter registry was constant over time and consistent with prior smaller studies. The findings of this study, along with ongoing efforts to understand and mitigate risk, will be critical to improve the lifetime management of patients with heart disease involving the RVOT. Although endocarditis can be a serious adverse outcome, TPVR remains an important tool in the management of RVOT dysfunction.

Comparison of postprocedural new-onset atrial fibrillation between transcatheter and surgical aortic valve replacement: A systematic review and meta-analysis based on 16 randomized controlled trials.

BACKGROUND: Presently, transcatheter aortic valve replacement (TAVR) as an effective and convenient intervention has been adopted extensively for patients with severe aortic disease. However, after surgical aortic valve replacement (SAVR) and TAVR, the incidence of new-onset atrial fibrillation (NOAF) is prevalently found. This meta-analysis was designed to comprehensively compare the incidence of NOAF at different times after TAVR and SAVR for patients with severe aortic disease. METHODS: A systematic search of PubMed, Embase, Cochrane Library, and Web of Science up to October 1, 2020 was conducted for relevant studies that comparing TAVR and SAVR in the treatment of severe aortic disease. The primary outcomes were the incidence of NOAF with early, midterm and long term follow-up. The secondary outcomes included permanent pacemaker (PM) implantation, myocardial infarction (MI), cardiogenic shock, as well as mortality and other complications. Two reviewers assessed trial quality and extracted the data independently. All statistical analyses were performed using the standard statistical procedures provided in Review Manager 5.2. RESULTS: A total of 16 studies including 13,310 patients were identified. The pooled results indicated that, compared with SAVR, TAVR experienced a significantly lower incidence of 30-day/in-hospital, 1-year, 2-year, and 5-year NOAF, with pooled risk ratios (RRs) of 0.31 (95% confidence interval [CI] 0.23-0.41; 5725 pts), 0.30 (95% CI 0.24-0.39; 6321 pts), 0.48 (95% CI 0.38-0.61; 3441 pts), and 0.45 (95% CI 0.37-0.55; 2268 pts) respectively. In addition, TAVR showed lower incidence of MI (RR 0.62; 95% CI 0.40-0.97) and cardiogenic shock (RR 0.34; 95% CI 0.19-0.59), but higher incidence of permanent PM (RR 3.16; 95% CI 1.61-6.21) and major vascular complications (RR 2.22; 95% CI 1.14-4.32) at 30-day/in-hospital. At 1- and 2-year after procedure, compared with SAVR, TAVR experienced a significantly higher incidence of neurological events, transient ischemic attacks (TIA), permanent PM, and major vascular complications, respectively. At 5-year after procedure, compared with SAVR, TAVR experienced a significantly higher incidence of TIA and re-intervention respectively. There was no difference in 30-day, 1-year, 2-year, and 5-year all-cause or cardiovascular mortality as well as stroke between TAVR and SAVR. CONCLUSIONS: Our analysis showed that TAVR was superior to SAVR in decreasing the both short and long term postprocedural NOAF. TAVR was equal to SAVR in early, midterm and long term mortality. In addition, TAVR showed lower incidence of 30-day/in-hospital MI and cardiogenic shock after procedure. However, pooled results showed that TAVR was inferior to SAVR in reducing permanent pacemaker implantation, neurological events, TIA, major vascular complications, and re-intervention.

Cardiovascular procedural deferral and outcomes over COVID-19 pandemic phases: A multi-center study.

BACKGROUND: The COVID-19 pandemic has disrupted routine cardiovascular care, with unclear impact on procedural deferrals and associated outcomes across diverse patient populations. METHODS: Cardiovascular procedures performed at 30 hospitals across 6 Western states in 2 large, non-profit healthcare systems (Providence St. Joseph Health and Stanford Healthcare) from December 2018-June 2020 were analyzed for changes over time. Risk-adjusted in-hospital mortality was compared across pandemic phases with multivariate logistic regression. RESULTS: Among 36,125 procedures (69% percutaneous coronary intervention, 13% coronary artery bypass graft surgery, 10% transcatheter aortic valve replacement, and 8% surgical aortic valve replacement), weekly volumes changed in 2 distinct phases after the initial inflection point on February 23, 2020: an initial period of significant deferral (COVID I: March 15-April 11) followed by recovery (COVID II: April 12 onwards). Compared to pre-COVID, COVID I patients were less likely to be female (P = .0003), older (P < .0001), Asian or Black (P = .02), or Medicare insured (P < .0001), and COVID I procedures were higher acuity (P < .0001), but not higher complexity. In COVID II, there was a trend toward more procedural deferral in regions with a higher COVID-19 burden (P = .05). Compared to pre-COVID, there were no differences in risk-adjusted in-hospital mortality during both COVID phases. CONCLUSIONS: Significant decreases in cardiovascular procedural volumes occurred early in the COVID-19 pandemic, with disproportionate impacts by race, gender, and age. These findings should inform our approach to future healthcare disruptions.

Disability-free survival after major cardiac surgery: a population-based retrospective cohort study.

BACKGROUND: Cardiovascular research has traditionally been dedicated to "tombstone" outcomes, with little attention dedicated to the patient's perspective. We evaluated disability-free survival as a patient-defined outcome after cardiac surgery. METHODS: We conducted a retrospective cohort study of patients aged 40 years and older who underwent coronary artery bypass grafting (CABG) or single or multiple valve (aortic, mitral, tricuspid) surgery in Ontario between Oct. 1, 2008, and Dec. 31, 2016. The primary outcome was disability (a composite of stroke, 3 or more nonelective hospital admissions and admission to a long-term care facility) within 1 year after surgery. We assessed the procedure-specific risk of disability using cumulative incidence functions, and the relative effect of covariates on the subdistribution hazard using Fine and Gray models. RESULTS: The study included 72 824 patients. The 1-year incidence of disability and death was 2431 (4.6%) and 1839 (3.5%) for CABG, 677 (6.5%) and 539 (5.2%) for single valve, 118 (9.0%) and 140 (10.7%) for multiple valve, 718 (9.0%) and 730 (9.2%) for CABG and single valve, and 87 (13.1%) and 94 (14.1%) for CABG and multiple valve surgery, respectively. With CABG as the reference group, the adjusted hazard ratios for disability were 1.34 (95% confidence interval [CI] 1.21-1.48) after single valve, 1.43 (95% CI 1.18-1.75) after multiple valve, 1.38 (95% CI 1.26-1.51) after CABG and single valve, and 1.78 (95% CI 1.43-2.23) after CABG and multiple valve surgery. Combined CABG and multiple valve surgery, heart failure, creatinine 180 µmol/L or greater, alcohol use disorder, dementia and depression were independent risk factors for disability. INTERPRETATION: The cumulative incidence of disability was lowest after CABG and highest after combined CABG and multiple valve surgery. Our findings point to a need for models that predict personalized disability risk to enable better patient-centred care.

Clinical Outcomes of Adults With Bicuspid Aortic Valve: A European Perspective.

OBJECTIVE: To describe the clinical history of patients with a wide age range diagnosed with bicuspid aortic valve (BAV) and no surgical indication and to evaluate the long-term outcome of patients with BAV referred for elective surgery. PATIENTS AND METHODS: Between 2005 and 2017, 350 consecutive patients with no surgical indication (surveillance group, mean age 53±16, 71% men) and 191 with a surgical indication (surgical group, mean age 59±13, 71% men) were prospectively included. Median follow-up was 80 (32 to 115) months. RESULTS: In the surveillance group, the 5-year and 10-year survival rates were 93±1% and 89±2%, respectively, with a relative survival of patients with BAV compared with an age- and sex-matched control population of 98.7%. During follow-up, the cumulative 10-year incidence of aortic valve and aorta surgery was high; of 35±4%, the incidence of native valve infective endocarditis (IE) of 0.2% per patient-year, and no cases of aortic dissection were observed. In the surgical group, the 5-year and 10-year survival rates were 97±1% and 89±3%, respectively, with a relative survival of 99.4% compared with the general population. The incidence of IE was 0.4% per patient-year, and no cases of aortic dissection were observed. CONCLUSION: This regional cohort shows that the 10-year survival rates of patients with BAV and a wide age range, but mostly middle-aged adults, were similar to those of the general population with a very low rate of complications. Adherence to prophylactic surgical indications and younger age might have contributed to this lack of difference.

Reasons for Screen Failure for Transcatheter Mitral Valve Repair and Replacement.

Despite an expanding armamentarium of devices, many patients with mitral regurgitation referred for transcatheter mitral valve repair (TMVr) or replacement (TMVR) do not meet strict clinical trial inclusion and exclusion criteria. We sought to understand the rates that patients were excluded from transcatheter mitral valve therapies and reasons why. We retrospectively analyzed the medical charts and correspondence related to patients referred to our tertiary valve center for TMVr or TMVR between June 2016 and September 2019. Patients were screened for eligibility by our structural Heart Team for either TMVr or TMVR. If TMVr or TMVR was not offered, the reason for screen failure was recorded and categorized. Over the 3-year period, 564 patients were referred for TMVr and orTMVR. Out of these, 15.9% were determined to be eligible for, and underwent, surgical repair or replacement. Ninety-two patients (16.3%) underwent TMVr or TMVR. The majority of patients (343 of 564, 60.8%) ultimately did not undergo intervention. The primary reason for exclusion was clinical in 38.5%, issues related to patient preference of care delivery in 38.8%, anatomical in 13.7%, and futility in 9.0%. In contemporary real-world practice, the majority of patients with mitral regurgitation referred for transcatheter therapies are excluded. Clinical trials testing new transcatheter devices should be encouraged to record and report reasons for screen failure and follow these patients to better understand optimal timing of intervention, address challenging anatomies, and, ultimately, improve penetrance of these novel therapies.

Relation of Institutional Mitral Valve Surgical Volume to Surgical and Transcatheter Outcomes in Medicare Patients.

There are limited data to support proposed increases to the minimum institutional mitral valve (MV) surgery volume required to begin a transcatheter mitral valve repair (TMVr) program. The current study examined the association between institutional MV procedure volumes and outcomes. All 2017 Medicare fee-for-service patients who received a TMVr or MV surgery procedure were included and analyzed separately. The exposure was institutional MV surgery volume: low (1 to 24), medium (25 to 39) or high (40+). Outcomes were in-hospital mortality and 1-year postdischarge mortality and cardiovascular rehospitalization. For MV surgery patients, in-hospital mortality rates were 6.4% at low-volume, 8.7% at medium-volume and 9.8% at high-volume facilities. Rates were significantly higher for low-volume [OR = 1.50, 95% CI (1.23 to 1.84)] and medium-volume [OR = 1.33, 95% CI (1.06 to 1.67)] compared with high-volume facilities. There was no statistically significant relationship between institutional MV surgery volume and in-hospital mortality for TMVr patients, either at low-volume [OR = 1.52, 95% CI (0.56, 4.13)] or medium-volume [OR = 1.58, 95% CI (0.82, 3.02)] facilities, compared with high-volume facilities. Across all volume categories, in-hospital mortality rates for TMVr patients were relatively low (2.3% on average). For both cohorts, the rates of 1-year mortality and cardiovascular rehospitalizations were not significantly higher at low- or medium-volume MV surgery facilities, as compared with high-volume. In conclusion, among Medicare patients, there was a relation between institutional MV surgery volume and in-hospital mortality for MV surgery patients, but not for TMVr patients.

Relative survival after aortic valve surgery in patients with bicuspid aortic valves.

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.

Transcatheter Tricuspid Valve Intervention in Patients With Previous Left Valve Surgery.

BACKGROUND: Scarce data exist on patients with previous left valve surgery (PLVS) undergoing transcatheter tricuspid valve intervention (TTVI). This study sought to investigate the procedural and early outcomes in patients with PLVS undergoing TTVI. METHODS: This was a subanalysis of the multicenter TriValve registry including 462 patients, 82 (18%) with PLVS. Data were analyzed according to the presence of PLVS in the overall cohort and in a propensity score-matched population including 51 and 115 patients with and without PLVS, respectively. RESULTS: Patients with PLVS were younger (72 ± 10 vs 78 ± 9 years; p < 0.01) and more frequently female (67.1% vs 53.2%; P = 0.02). Similar rates of procedural success (PLVS 80.5%; no-PLVS 82.1%; P = 0.73), and 30-day mortality (PLVS 2.4%, no-PLVS 3.4%; P = 0.99) were observed. After matching, there were no significant differences in both all-cause rehospitalisation (PLVS 21.1%, no-PLVS 26.5%; P = 0.60) and all-cause mortality (PLVS 9.8%, no-PLVS 6.7%; P = 0.58). At last follow-up (median 6 [interquartile range 1-12] months after the procedure), most patients (81.8%) in the PLVS group were in NYHA functional class I-II (P = 0.12 vs no-PLVS group), and TR grade was ≤ 2 in 82.6% of patients (P = 0.096 vs no-PVLS group). A poorer right ventricular function and previous heart failure hospitalization determined increased risks of procedural failure and poorer outcomes at follow-up, respectively. CONCLUSIONS: In patients with PLVS, TTVI was associated with high rates of procedural success and low early mortality. However, about one-third of patients required rehospitalisation or died at midterm follow-up. These results would support TTVI as a reasonable alternative to redo surgery in patients with PLVS and suggest the importance of earlier treatment to improve clinical outcomes.