Aortic valve replacement for aortic stenosis: Influence of centre volume on TAVR adoption rates and outcomes in France.

BACKGROUND: Transcatheter (TAVR) has supplanted surgical (SAVR) aortic valve replacement (AVR). AIM: To evaluate whether adoption of this technology has varied according to centre volume at the nationwide level. METHODS: From an administrative hospital-discharge database, we collected data on all AVRs performed in France between 2007 and 2019. Centres were divided into terciles based on the annual number of SAVRs performed in 2007-2009 ("before TAVR era"). RESULTS: A total of 192,773 AVRs (134,662 SAVRs and 58,111 TAVRs) were performed in 47 centres. The annual number of AVRs and TAVRs increased significantly and linearly in low-volume (<152 SAVRs/year; median 106, interquartile range [IQR] 75-129), middle-volume (152-219 SAVRs/year; median 197, IQR 172-212) and high-volume (>219 SAVRs/year; median 303, IQR 268-513) terciles, but to a greater degree in the latter (+14, +16 and +24 AVRs/centre/year and +16, +19 and +31 TAVRs/centre/year, respectively; PANCOVA<0.001). Charlson Comorbidity Index and in-hospital death rates declined from 2010 to 2019 in all terciles (all Ptrend<0.05). In 2017-2019, after adjusting for age, sex and Charlson Comorbidity Index, there was a trend toward lower death rates in the high-volume tercile (P=0.06) for SAVR, whereas death rates were similar for TAVR irrespective of tercile (P=0.27). Similar results were obtained when terciles were defined based on number of interventions performed in the last instead of the first 3years. Importantly, even centres in the lowest-volume tercile performed a relatively high number of interventions (150 TAVRs/year/centre). CONCLUSIONS: In a centralized public healthcare system, the total number of AVRs increased linearly between 2007 and 2019, mostly due to an increase in TAVR, irrespective of centre volume. Progressive declines in patient risk profiles and death rates were observed in all terciles; in 2017-2019 death rates were similar in all terciles, although lower in high-volume centres for SAVR.

Temporal Trends, Outcomes, and Predictors of Next-Day Discharge and Readmission Following Uncomplicated Evolut Transcatheter Aortic Valve Replacement: A Propensity Score-Matched Analysis.

BACKGROUND: Next-day discharge (NDD) outcomes following uncomplicated self-expanding transcatheter aortic valve replacement have not been studied. Here, we compare readmission rates and clinical outcomes in NDD versus non-NDD transcatheter aortic valve replacement with Evolut. METHODS AND RESULTS: Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry patients (n=29 597) undergoing elective transcatheter aortic valve replacement with self-expanding supra-annular valves (Evolut R, PRO, and PRO+) from July 2019 to June 2021 were stratified by postprocedure length of stay: ≤1 day (NDD) versus >1 day (non-NDD). Propensity score matching was used to compare risk adjusted 30-day readmission rates and 1-year outcomes in NDD versus non-NDD, and multivariable regression to determine predictors of NDD and readmission. Between the first and last calendar quarter, the rate of NDD increased from 45.4% to 62.1% and median length of stay decreased from 2 days to 1. Propensity score matching produced relatively well-matched NDD and non-NDD cohorts (n=10 549 each). After matching, NDD was associated with lower 30-day readmission rates (6.3% versus 8.4%; P<0.001) and 1-year adverse outcomes (death, 7.0% versus 9.3%; life threatening/major bleeding, 1.6% versus 3.4%; new permanent pacemaker implantation/implantable cardioverter-defibrillator, 3.6 versus 11.0%; [all P<0.001]). Predictors of NDD included non-Hispanic ethnicity, preexisting permanent pacemaker implantation/implantable cardioverter-defibrillator, and previous surgical aortic valve replacement. CONCLUSIONS: Most patients undergoing uncomplicated self-expanding Evolut transcatheter aortic valve replacement are discharged the next day. This study found that NDD can be predicted from baseline patient characteristics and was associated with favorable 30-day and 1-year outcomes, including low rates of permanent pacemaker implantation and readmission.

National Trends and Outcomes of Acute Myocardial Infarction After Transcatheter Aortic Valve Replacement.

BACKGROUND: Prior studies have reported decreased use of an invasive approach for acute myocardial infarction (AMI) in patients undergoing transcatheter aortic valve replacement (TAVR). OBJECTIVES: The aim of this study was to determine whether prior TAVR affects the use of subsequent coronary revascularization and outcomes of AMI in a contemporary national data set. METHODS: Consecutive TAVR patients from 2016 to 2022 were identified from the U.S. Vizient Clinical Data Base who were hospitalized after the index TAVR hospitalization with ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI). Patients with STEMI or NSTEMI with or without prior TAVR from the same time period were compared for the use of coronary angiography, revascularization, and in-hospital outcomes. Propensity score matching was used to account for imbalances in patient characteristics. RESULTS: Among 206,229 patients who underwent TAVR, the incidence of STEMI was 25 events per 100,000 person-years of follow-up, and that of NSTEMI was 229 events per 100,000 person-years. After propensity matching, the use of coronary revascularization was similar in the prior TAVR and no TAVR cohorts in both the STEMI (65.3% vs 63.9%; P = 0.81) and NSTEMI (41.4% vs 41.7%; P = 0.88) subgroups. Compared with patients without prior TAVR, in-hospital mortality was higher in the prior TAVR cohort in patients with STEMI (27.1% vs 16.7%; P = 0.03) and lower in those with NSTEMI (5.8% vs 8.2%; P = 0.02). CONCLUSIONS: In this large, national retrospective study, AMI events after TAVR were infrequent. There were no differences in the use of coronary revascularization for STEMI or NSTEMI in TAVR patients compared with the non-TAVR population. In-hospital mortality for STEMI is higher in TAVR patients compared with those without prior TAVR.

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.

Severe aortic stenosis: secular trends of incidence and outcomes.

BACKGROUND AND AIMS: Severe aortic stenosis (AS) is the guideline-based indication for aortic valve replacement (AVR), which has markedly increased with transcatheter approaches, suggesting possible increasing AS incidence. However, reported secular trends of AS incidence remain contradictory and lack quantitative Doppler echocardiographic ascertainment. METHODS: All adults residents in Olmsted County (MN, USA) diagnosed over 20 years (1997-2016) with incident severe AS (first diagnosis) based on quantitatively defined measures (aortic valve area ≤ 1 cm2, aortic valve area index ≤ 0.6 cm2/m2, mean gradient ≥ 40 mmHg, peak velocity ≥ 4 m/s, Doppler velocity index ≤ 0.25) were counted to define trends in incidence, presentation, treatment, and outcome. RESULTS: Incident severe AS was diagnosed in 1069 community residents. The incidence rate was 52.5 [49.4-55.8] per 100 000 patient-year, slightly higher in males vs. females and was almost unchanged after age and sex adjustment for the US population 53.8 [50.6-57.0] per 100 000 residents/year. Over 20 years, severe AS incidence remained stable (P = .2) but absolute burden of incident cases markedly increased (P = .0004) due to population growth. Incidence trend differed by sex, stable in men (incidence rate ratio 0.99, P = .7) but declining in women (incidence rate ratio 0.93, P = .02). Over the study, AS clinical characteristics remained remarkably stable and AVR performance grew and was more prompt (from 1.3 [0.1-3.3] years in 1997-2000 to 0.5 [0.2-2.1] years in 2013-16, P = .001) but undertreatment remained prominent (>40%). Early AVR was associated with survival benefit (adjusted hazard ratio 0.55 [0.42-0.71], P < .0001). Despite these improvements, overall mortality (3-month 8% and 3-year 36%), was swift, considerable and unabated (all P ≥ .4) throughout the study. CONCLUSIONS: Over 20 years, the population incidence of severe AS remained stable with increased absolute case burden related to population growth. Despite stable severe AS presentation, AVR performance grew notably, but while declining, undertreatment remained substantial and disease lethality did not yet decline. These population-based findings have important implications for improving AS management pathways.

Trends in Transcatheter and Surgical Aortic Valve Replacement Among Older Adults in the United States.

BACKGROUND: Recent trends, including survival beyond 30 days, in aortic valve replacement (AVR) following the expansion of indications for transcatheter aortic valve replacement (TAVR) are not well-understood. OBJECTIVES: The authors sought to characterize the trends in characteristics and outcomes of patients undergoing AVR. METHODS: The authors analyzed Medicare beneficiaries who underwent TAVR and SAVR in 2012 to 2019. They evaluated case volume, demographics, comorbidities, 1-year mortality, and discharge disposition. Cox proportional hazard models were used to assess the annual change in outcomes. RESULTS: Per 100,000 beneficiary-years, AVR increased from 107 to 156, TAVR increased from 19 to 101, whereas SAVR declined from 88 to 54. The median [interquartile range] age remained similar from 77 [71-83] years to 78 [72-84] years for overall AVR, decreased from 84 [79-88] years to 81 [75-86] years for TAVR, and decreased from 76 [71-81] years to 72 [68-77] years for SAVR. For all AVR patients, the prevalence of comorbidities remained relatively stable. The 1-year mortality for all AVR decreased from 11.9% to 9.4%. Annual change in the adjusted odds of 1-year mortality was 0.93 (95% CI: 0.92-0.94) for TAVR and 0.98 (95% CI: 0.97-0.99) for SAVR, and 0.94 (95% CI: 0.93-0.95) for all AVR. Patients discharged to home after AVR increased from 24.2% to 54.7%, primarily driven by increasing home discharge after TAVR. CONCLUSIONS: The advent of TAVR has led to about a 60% increase in overall AVR in older adults. Improving outcomes in AVR as a whole following the advent of TAVR with increased access is a reassuring trend.

Association Between Patient Survival and Clinician Variability in Treatment Rates for Aortic Valve Stenosis.

Background Patients with symptomatic severe aortic stenosis (ssAS) have a high mortality risk and compromised quality of life. Surgical/transcatheter aortic valve replacement (AVR) is a Class I recommendation, but it is unclear if this recommendation is uniformly applied. We determined the impact of managing cardiologists on the likelihood of ssAS treatment. Methods and Results Using natural language processing of Optum electronic health records, we identified 26 438 patients with newly diagnosed ssAS (2011-2016). Multilevel, multivariable Fine-Gray competing risk models clustered by cardiologists were used to determine the impact of cardiologists on the likelihood of 1-year AVR treatment. Within 1 year of diagnosis, 35.6% of patients with ssAS received an AVR; however, rates varied widely among managing cardiologists (0%, lowest quartile; 100%, highest quartile [median, 29.6%; 25th-75th percentiles, 13.3%-47.0%]). The odds of receiving AVR varied >2-fold depending on the cardiologist (median odds ratio for AVR, 2.25; 95% CI, 2.14-2.36). Compared with patients with ssAS of cardiologists with the highest treatment rates, those treated by cardiologists with the lowest AVR rates experienced significantly higher 1-year mortality (lowest quartile, adjusted hazard ratio, 1.22, 95% CI, 1.13-1.33). Conclusions Overall AVR rates for ssAS were low, highlighting a potential challenge for ssAS management in the United States. Cardiologist AVR use varied substantially; patients treated by cardiologists with lower AVR rates had higher mortality rates than those treated by cardiologists with higher AVR rates.

Inequities in Aortic Stenosis and Aortic Valve Replacement Between Black/African-American, White, and Hispanic Residents of Maryland.

Background Racial and ethnic inequities exist in surgical aortic valve replacement for aortic stenosis (AS), and early studies have suggested similar inequities in transcatheter aortic valve replacement. Methods and Results We performed a retrospective analysis of the Maryland Health Services Cost Review Commission inpatient data set from 2016 to 2018. Black patients had half the incidence of any inpatient AS diagnosis compared with White patients (incidence rate ratio [IRR], 0.50; 95% CI, 0.48-0.52; P<0.001) and Hispanic patients had one fourth the incidence compared with White patients (IRR, 0.25; 95% CI, 0.22-0.29; P<0.001). Conversely, the incidence of any inpatient mitral regurgitation diagnosis did not differ between White and Black patients (IRR, 1.00; 95% CI, 0.97-1.03; P=0.97) but was significantly lower in Hispanic compared with White patients (IRR, 0.36; 95% CI, 0.33-0.40; P<0.001). After multivariable adjustment, Black race was associated with a lower incidence of surgical aortic valve replacement (IRR, 0.67; 95% CI, 0.55-0.82 P<0.001 relative to White race) and transcatheter aortic valve replacement (IRR, 0.77; 95% CI, 0.65-0.90; P=0.002) among those with any inpatient diagnosis of AS. Hispanic patients had a similar rate of surgical aortic valve replacement and transcatheter aortic valve replacement compared with White patients. Conclusions Hospitalization with any diagnosis of AS is less common in Black and Hispanic patients than in White patients. In hospitalized patients with AS, Black race is associated with a lower incidence of both surgical aortic valve replacement and transcatheter aortic valve replacement compared with White patients, whereas Hispanic patients have a similar incidence of both. The reasons for these inequities are likely multifactorial.

Temporal Trends and Drivers of Heart Team Utilization in Transcatheter Aortic Valve Replacement: A Population-Based Study in Ontario, Canada.

Background The multidisciplinary Heart Team (HT) is recommended for management decisions for transcatheter aortic valve replacement (TAVR) candidates, and during TAVR procedures. Empiric evidence to support these recommendations is limited. We aimed to explore temporal trends, drivers, and outcomes associated with HT utilization. Methods and Results TAVR candidates were identified in Ontario, Canada, from April 1, 2012 to March 31, 2019. The HT was defined as having a billing code for both a cardiologist and cardiac surgeon during the referral period. The procedural team was defined as a billing code during the TAVR procedure. Hierarchical logistical models were used to determine the drivers of HT. Median odds ratios were calculated to quantify the degree of variation among hospitals. Of 10 412 patients referred for TAVR consideration, 5489 (52.7%) patients underwent a HT during the referral period, with substantial range between hospitals (median odds ratio of 1.78). Utilization of a HT for TAVR referrals declined from 69.9% to 41.1% over the years of the study. Patient characteristics such as older age, frailty and dementia, and hospital characteristics including TAVR program size, were found associated with lower HT utilization. In TAVR procedures, the procedural team included both cardiologists and cardiac surgeons in 94.9% of cases, with minimal variation over time or between hospitals. Conclusions There has been substantial decline in HT utilization for TAVR candidates over time. In addition, maturity of TAVR programs was associated with lower HT utilization.

Geographic and Demographic Variability in Transcatheter Aortic Valve Replacement Dispersion in the United States.

Background Transcatheter aortic valve replacement (TAVR) has transformed the management of aortic valve stenosis. However, little national data are available characterizing the geographic and demographic dispersion of this disruptive technology relative to surgical aortic valve replacement (SAVR). Methods and Results In this US claims-based study, we analyzed a 100% sample of fee-for-service Medicare beneficiaries from 2012 to 2017 and examined national rates of TAVR versus SAVR. Procedure rates were compared across years as a function of age, sex, race, and geography for TAVR and SAVR beneficiaries. There was significant growth in TAVR from 15.4 beneficiaries/100 000 enrollees in 2012 to 90.6 in 2017 (P<0.001). SAVR rates declined from 92.8 beneficiaries/100 000 enrollees in 2012 to 63.5 in 2017 (P<0.001). The growth of TAVR varied as a function of age (P<0.0001). While TAVR was the dominant strategy among beneficiaries ≥85 and 75 to 84 years old, SAVR was more common among beneficiaries 65 to 74 years old. TAVR was also used more frequently than SAVR among women (P<0.001). While TAVR increased among all races, it was less commonly used among non-White beneficiaries (P<0.001). Contemporary use of TAVR relative to SAVR varied significantly by geographic location, with a TAVR:SAVR ratio in 2017 of 1.24 in the Midwest and 1.68 in the Northeast (P<0.001). Conclusions In 2017, the number of Medicare beneficiaries receiving TAVR exceeded SAVR for the first time in the United States. There is significant variation, however, in the geographic expansion of TAVR and in patient demographics relative to SAVR.

Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk.

BACKGROUND: In low surgical risk patients with symptomatic severe aortic stenosis, the PARTNER 3 (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis) trial demonstrated superiority of transcatheter aortic valve replacement (TAVR) versus surgery for the primary endpoint of death, stroke, or re-hospitalization at 1 year. OBJECTIVES: This study determined both clinical and echocardiographic outcomes between 1 and 2 years in the PARTNER 3 trial. METHODS: This study randomly assigned 1,000 patients (1:1) to transfemoral TAVR with the SAPIEN 3 valve versus surgery (mean Society of Thoracic Surgeons score: 1.9%; mean age: 73 years) with clinical and echocardiography follow-up at 30 days and at 1 and 2 years. This study assessed 2-year rates of the primary endpoint and several secondary endpoints (clinical, echocardiography, and quality-of-life measures) in this as-treated analysis. RESULTS: Primary endpoint follow-up at 2 years was available in 96.5% of patients. The 2-year primary endpoint was significantly reduced after TAVR versus surgery (11.5% vs. 17.4%; hazard ratio: 0.63; 95% confidence interval: 0.45 to 0.88; p = 0.007). Differences in death and stroke favoring TAVR at 1 year were not statistically significant at 2 years (death: TAVR 2.4% vs. surgery 3.2%; p = 0.47; stroke: TAVR 2.4% vs. surgery 3.6%; p = 0.28). Valve thrombosis at 2 years was increased after TAVR (2.6%; 13 events) compared with surgery (0.7%; 3 events; p = 0.02). Disease-specific health status continued to be better after TAVR versus surgery through 2 years. Echocardiographic findings, including hemodynamic valve deterioration and bioprosthetic valve failure, were similar for TAVR and surgery at 2 years. CONCLUSIONS: At 2 years, the primary endpoint remained significantly lower with TAVR versus surgery, but initial differences in death and stroke favoring TAVR were diminished and patients who underwent TAVR had increased valve thrombosis. (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [PARTNER 3]; NCT02675114).

Expansion of transcatheter aortic valve replacement in the United States.

BACKGROUND: Patterns of diffusion of TAVR in the United States (U.S.) and its relation to racial disparities in TAVR utilization remain unknown. METHODS: We identified TAVR hospitals in the continental U.S. from 2012-2017 using Medicare database and mapped them to Hospital Referral Regions (HRR). We calculated driving distance from each residential ZIP code to the nearest TAVR hospital and calculated the proportion of the U.S. population, in general and by race, that lived <100 miles driving distance from the nearest TAVR center. Using a discrete time hazard logistic regression model, we examined the association of hospital and HRR variables with the opening of a TAVR program. RESULTS: The number of TAVR hospitals increased from 230 in 2012 to 540 in 2017. The proportion of the U.S. population living <100 miles from nearest TAVR hospital increased from 89.3% in 2012 to 94.5% in 2017. Geographic access improved for all racial and ethnic subgroups: Whites (84.1%-93.6%), Blacks (90.0%- 97.4%), and Hispanics (84.9%-93.7%). Within a HRR, the odds of opening a new TAVR program were higher among teaching hospitals (OR 1.48, 95% CI 1.16-1.88) and hospital bed size (OR 1.44, 95% CI 1.37-1.52). Market-level factors associated with new TAVR programs were proportion of Black (per 1%, OR 0.78, 95% CI 0.69-0.89) and Hispanic (per 1%, OR 0.82, 95% CI 0.75-0.90) residents, the proportion of hospitals within the HRR that already had a TAVR program (per 10%, OR 1.07, 95% CI 1.03-1.11), P <.01 for all. CONCLUSION: The expansion of TAVR programs in the U.S. has been accompanied by an increase in geographic coverage for all racial subgroups. Further study is needed to determine reasons for TAVR underutilization in Blacks and Hispanics.

Aortic valve replacement in Germany in 2019.

AIMS: Both surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) are established options to treat aortic valve stenosis. We present the outcome of the complete cohort of all patients undergoing SAVR or TAVI in Germany during the calendar year 2019. METHODS AND RESULTS: Data concerning all isolated aortic valve procedures performed in Germany in 2019 were retrieved from the mandatory nationwide quality control program: 22,973 transvascular (TV)-TAVI procedures, 7905 isolated SAVR (iSAVR), and 1413 transapical (TA)-TAVI. Data was complete in 99.9% (n = 32,156). In-hospital mortality after TV-TAVI (2.3%) was significantly lower when compared with iSAVR (2.8%, p = 0.007) or TA-TAVI (6.3%; p < 0.001). Expected mortality was calculated with a new version of the German Aortic valve score (AKL Score) based on the data of either catheter-based (AKL-CATH) or surgical (AKL-CHIR) aortic valve replacements in Germany in 2018. TV-TAVI and iSAVR both showed lower observed mortality in 2019 than expected based on their respective performance in 2018, yielding an observed/expected (O/E) mortality ratio < 1. This was particularly apparent for patients at low risk. After exclusion of emergency procedures, in-hospital mortality after TV-TAVI (2.1%) and after iSAVR (2.1%) was identical, even though patients undergoing TV-TAVI showed a considerably higher perioperative risk profile. CONCLUSION: After excluding emergency procedures, in-hospital mortality of TV-TAVI and iSAVR in 2019 in Germany was identical. In 2019, TV-TAVI and iSAVR both show lower matched mortality ratios compared with 2018, which suggests technical improvements of both therapies.

Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement: Comprehensive Midterm Evaluation of Valve-in-Valve and Valve-in-Ring Implantation From the VIVID Registry.

BACKGROUND: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. METHODS: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate. RESULTS: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (P<0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (P=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P<0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P=0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P=0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; P=0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88-21.53; P<0.001) were both independently associated with repeat mitral valve replacement. CONCLUSIONS: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.

The Sky Is Not Falling: Surgical Perspectives on a New Transcatheter Paradigm.

The role of cardiac surgeons in the treatment of aortic valve disease is changing with the expansion of transcatheter aortic valve replacement. Recent trials in patients at low surgical risk will further this paradigm shift, and the future cardiac surgeons in this space remain uncertain. In this Viewpoint article, we discuss the role that surgeons can play in the future of structural heart medicine. We examine the potential effects of the low-risk transcatheter aortic valve replacement trials on overall operative volumes and how these effects may be limited through structured training programs and strong collaboration within the heart team. Finally, future considerations and cautions for the cardiac surgical community are discussed. The coming era presents an opportunity for growth, leadership, and strong interdisciplinary collaboration for the cardiac surgery community.

Aortic Valve Replacement in Young and Middle-Aged Adults: Current and Potential Roles of TAVR.

BACKGROUND: Contemporary practice patterns and outcomes for aortic valve replacement (AVR) among young and middle-aged adults are unknown given guideline modifications for surgical AVR (SAVR) and increasing transcatheter AVR (TAVR) acceptance. This study describes SAVR and TAVR use and outcomes using The Society of Thoracic Surgeons (STS) National Databases. METHODS: Adults 18 to 55 years of age in the Congenital Heart Surgery Database (CHSD) and the Adult Cardiac Surgery Database (ACSD) who underwent SAVR or TAVR from 2013 to 2018 were included. Perioperative characteristics and early outcomes were described by valve type. Multivariable regression identified determinants of death, length of hospital stay, and a composite end point of renal failure, persistent neurologic deficit, readmission, and reoperation. RESULTS: The study analyzed 1580 unique CHSD and 44,173 ACSD operations, 16% of which were performed in patients with congenital heart disease. Valve use included the following: TAVR, 1%; mechanical, 42%; bioprosthetic, 55%; autograft, 0.6%; homograft, 1.2%; and Ozaki, 0.4%. Over time, TAVR volumes increased by 167%. The 30-day mortality was as follows: TAVR, 3.8%; mechanical, 3.2%; bioprosthetic, 3.7%; autograft, 0.6%; homograft, 9%; and Ozaki, 3.4%. Stroke rate was lower for isolated SAVR vs isolated TAVR (0.9% vs 2.4%; P = .002). In multivariable analyses, mortality risk was lower with mechanical valves, congenital morbidity risk was higher with TAVR, and length of stay was shorter with TAVR. CONCLUSIONS: TAVR is increasingly used for adults younger than 55 years of age. Given the uniformly excellent results with SAVR, including both mortality and morbidity-particularly regarding stroke, our data favor SAVR in this population, but a prospective trial is needed. Ongoing efforts to harmonize variables and outcomes definitions between the ACSD and CHSD are valuable.

Smart materials in cardiovascular implants: Shape memory alloys and shape memory polymers.

Smart materials have intrinsic properties that change in a controlled fashion in response to external stimuli. Currently, the only smart materials with a significant clinical impact in cardiovascular implant design are shape memory alloys, particularly Nitinol. Recent prodigious progress in material science has resulted in the development of sophisticated shape memory polymers. In this article, we have reviewed the literature and outline the characteristics, advantages, and disadvantages of shape memory alloys and shape memory polymers which are relevant to clinical cardiovascular applications, and describe the potential of these smart materials for applications in coronary stents and transcatheter valves.