Epidemiology of Heart Valve Disease in Taiwan.

Studies conducted in developed nations have shown that increase in life expectancy has brought with it a rise in the incidence and treatment of degenerative aortic and mitral heart valve diseases. Current standards recommend valve replacement among even some asymptomatic patients. In this research, we examine the epidemiology of valvular heart disease and rate of valve replacement in Taiwan, where life expectancy now stands at 80.69 years. Patients were enrolled based on claims from a widely used national database and categorized into cohorts defined by type of valve disease and, further, by valve replacements and type of valve (mechanical, porcine, or bovine). Data, including disease type, age, and gender, were analyzed to determine annual and cumulative incidence rates and prosthetic usage from 2000 to 2017. Results showed that across the cohorts, the cumulative incidence rate in 2017 was 3.59%, and in the aortic valve cohort, the percentage of surgical valve replacement for those ≥60 years was 6.99%. Compared with other developed nations, this demonstrates that incidence rates are slightly higher, yet surgical replacements are less than half that of other developed nations. This under-treatment of patients with valvular heart disease presents an important public health challenge in Taiwan.

Structural Deterioration of Transcatheter Versus Surgical Aortic Valve Bioprostheses in the PARTNER-2 Trial.

BACKGROUND: It is unknown whether transcatheter valves will have similar durability as surgical bioprosthetic valves. Definitions of structural valve deterioration (SVD), based on valve related reintervention or death, underestimate the incidence of SVD. OBJECTIVES: This study sought to determine and compare the 5-year incidence of SVD, using new standardized definitions based on echocardiographic follow-up of valve function, in intermediate-risk patients with severe aortic stenosis given transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) in the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial and registry. METHODS: In the PARTNER 2A trial, patients were randomly assigned to receive either TAVR with the SAPIEN XT or SAVR, whereas in the SAPIEN 3 registry, patients were assigned to TAVR with the SAPIEN 3. The primary endpoint was the incidence of SVD, that is, the composite of SVD-related hemodynamic valve deterioration during echocardiographic follow-up and/or SVD-related bioprosthetic valve failure (BVF) at 5 years. RESULTS: Compared with SAVR, the SAPIEN-XT TAVR cohort had a significantly higher 5-year exposure adjusted incidence rates (per 100 patient-years) of SVD (1.61 ± 0.24% vs. 0.63 ± 0.16%), SVD-related BVF (0.58 ± 0.14% vs. 0.12 ± 0.07%), and all-cause (structural or nonstructural) BVF (0.81 ± 0.16% vs. 0.27 ± 0.10%) (p ≤ 0.01 for all). The 5-year rates of SVD (0.68 ± 0.18% vs. 0.60 ± 0.17%; p = 0.71), SVD-related BVF (0.29 ± 0.12% vs. 0.14 ± 0.08%; p = 0.25), and all-cause BVF (0.60 ± 0.15% vs. 0.32 ± 0.11%; p = 0.32) in SAPIEN 3 TAVR were not significantly different to a propensity score matched SAVR cohort. The 5-year rates of SVD and SVD-related BVF were significantly lower in SAPIEN 3 versus SAPIEN XT TAVR matched cohorts. CONCLUSIONS: Compared with SAVR, the second-generation SAPIEN XT balloon-expandable valve has a higher 5-year rate of SVD, whereas the third-generation SAPIEN 3 has a rate of SVD that was not different from SAVR. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII A [PARTNERII A]; NCT01314313; The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - PARTNER II - PARTNERII - S3 Intermediate [PARTNERII S3i]; NCT03222128).

Biologic Grafts for Use in Pelvic Organ Prolapse Surgery: a Contemporary Review.

PURPOSE OF REVIEW: Pelvic organ prolapse (POP) is a common condition and there is a plethora of surgical techniques available to address this problem. We present a review of biologic grafts, including the latest literature to help guide a surgeon's choice on the type of biologic materials to augment repairs. RECENT FINDINGS: Since the 2019 Food and Drug Administration (FDA) ban on mesh, including xenograft, there is a sparsity of biologic graft products available for POP repairs. This has led to a significant decrease in surgical application. Surgeons must be familiar with the biochemical properties, processing, and clinical application of biologic grafts prior to use. They should also be familiar with alternative operative techniques that utilize autografts, although there is limited outcome data on these techniques. With heightened awareness of mesh and its complications, biologic grafts have made a resurgence. Surgeons must be well versed on their available options. Current literature is limited, and studies have not demonstrated superiority of biologic graft over native tissue repairs for prolapse. Nevertheless, there is a role for these types of biologic graft material in specific patient populations. Future studies are warranted.

Contemporary trends in mitral valve surgery in East China: a 10-year experience.

BACKGROUND: Contemporary nationwide data from mainland China on trends in mitral valve surgery are scarce. The purpose of the present study was to review a single-center experience with mitral valve surgery over a 10-year period in East China. METHODS: Between July 2009 and June 2019, 3238 consecutive patients who underwent mitral valve surgery in our center were retrospectively reviewed. The patients were evenly divided into three periods: July 2009 to October 2012 (period I), November 2012 to February 2016 (period II), March 2016 to June 2019 (period III). RESULTS: The 3238 patients included 536 (16.6%) who had mitral valve repair and 2702 (83.4%) who had mitral valve replacement. Early mortalities for mitral valve repair and mitral valve replacement were 0.2% and 0.9%, respectively. There were trends towards a higher proportion of degenerative valve lesions (24.6%, 35.8%, 54.7% in periods I, II, and III, respectively) and a lower proportion of rheumatic valve lesions (71.0%, 62.6%, 38.0%) in more recent years. The proportions of minimally invasive surgery (0.7%, 2.1%, 30.2%), mitral valve repair (8.3%, 15.4%, 27.5%), use of a bioprosthesis (10.1%, 17.0%, 23.1%), and concomitant tricuspid valve procedures (13.2%, 28.5%, 46.0%) increased dramatically, while early mortality remained constant during the 10-year period (1.0%, 0.3%, 0.9%). CONCLUSIONS: In the past 10 years, the spectrum of mitral valve disease experienced a trend towards more degenerative valve lesions and less rheumatic valve lesions in East China. Mitral valve repair, bioprostheses, tricuspid valve repair, and minimally invasive surgery have been more often applied in recent years.

Bioprosthetic Aortic Valve Leaflet Thickening in the Evolut Low Risk Sub-Study.

BACKGROUND: Subclinical leaflet thrombosis has been reported after bioprosthetic aortic valve replacement, characterized using 4-dimensional computed tomographic imaging by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM). The incidence and clinical implications of these findings remain unclear. OBJECTIVES: The aim of this study was to determine the frequency, predictors, and hemodynamic and clinical correlates of HALT and RLM after aortic bioprosthetic replacement. METHODS: A prospective subset of patients not on oral anticoagulation enrolled in the Evolut Low Risk randomized trial underwent computed tomographic imaging 30 days and 1 year after transcatheter aortic valve replacement (TAVR) or surgery. The primary endpoint was the frequency of HALT at 30 days and 1 year, analyzed by an independent core laboratory using standardized definitions. Secondary endpoints included RLM, mean aortic gradient, and clinical events at 30 days and 1 year. RESULTS: At 30 days, the frequency of HALT was 31 of 179 (17.3%) for TAVR and 23 of 139 (16.5%) for surgery; the frequency of RLM was 23 of 157 (14.6%) for TAVR and 19 of 133 (14.3%) for surgery. At 1 year, the frequency of HALT was 47 of 152 (30.9%) for TAVR and 33 of 116 (28.4%) for surgery; the frequency of RLM was 45 of 145 (31.0%) for TAVR and 30 of 111 (27.0%) for surgery. Aortic valve hemodynamic status was not influenced by the presence or severity of HALT or RLM at either time point. The rates of HALT and RLM were similar after the implantation of supra-annular, self-expanding transcatheter, or surgical bioprostheses. CONCLUSIONS: The presence of computed tomographic imaging abnormalities of aortic bioprostheses were frequent but dynamic in the first year after self-expanding transcatheter and surgical aortic valve replacement, but these findings did not correlate with aortic valve hemodynamic status after aortic valve replacement in patients at low risk for surgery. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).

Contemporary Outcomes of Surgical Aortic Valve Replacement in Japan.

BACKGROUND: Given the rapid expansion in the use of transcatheter aortic valve implantation (TAVI), recent outcomes of surgical aortic valve replacement (SAVR) should be re-evaluated.Methods and Results:Using the data from the Japan Cardiovascular Surgery Database of 160 enrolled hospitals, trends in elective isolated SAVR were evaluated until the introduction of TAVI in Japan. Trend analyses were performed over 4 periods: period 1, 2008-2009 (4,415 cases); period 2, 2010-2011 (4,861 cases); period 3, 2012-2013 (5,674 cases); and period 4, 2014-2015 (5,563 cases). Baseline risk, evaluated on JapanSCORE, increased significantly over the 4 periods, from a median of 1.56 (IQR, 0.99-2.61) in period 1 to 2.08 (IQR, 1.33-3.96) in period 4 (P<0.001, trend test). Despite the increased risk, the composite major complication and operative mortality rate decreased significantly (10.7% in period 1 to 9.2% in period 4, P=0.01). Using a risk-adjusted model, the OR of operative mortality was 1.61 (95% CI: 1.29-2.02) in period 1 (P<0.0001) compared with period 4. An increase in the use of bioprostheses was also observed, from 60.4% to 76.8% (P<0.001) over the 4 periods. CONCLUSIONS: Even in a short 8-year period, SAVR outcomes improved in Japan. This should be taken into account when discussing the indications for aortic valve intervention.

A paradox in sex-specific clinical outcomes after bioresorbable scaffold implantation: 2-year results from the AIDA trial.

BACKGROUND: Females are underrepresented in clinical trials evaluating new stent technologies whilst results may differ between the sexes. Females are known to have smaller, more tortuous coronary arteries and have generally more comorbidities. On the other hand, they may have smaller plaque burden. This subgroup-analysis sought to assess sex-specific outcomes after Absorb bioresorbable vascular scaffold (BVS) or XIENCE everolimus-eluting stent (EES) implantation. METHODS: The AIDA trial was an investigator-initiated, non-inferiority, all-comers trial, in which 1845 patients were randomly assigned to either Absorb BVS or XIENCE EES. Baseline clinical, angiography and procedural variables, as well as 2-year clinical outcomes were analyzed by sex and device modality. RESULTS: Of the 1845 randomized patients, 475 (25.7%) were females. The 2-year rates of target vessel failure (TVF) with Absorb BVS versus XIENCE EES in females were 6.4% versus 10.6% (HR 0.59; 95% CI: 0.31-1.11; p = 0.10) and in males 12.7% versus 9.7% (HR 1.34; 95% CI: 0.98-1.85; p = 0.07). Males treated with Absorb BVS were at higher risk for TVF compared to females treated with Absorb BVS (HR 2.06; 95% CI 1.21-3.53; p = 0.007). Definite/probable device thrombosis occurred in females with Absorb BVS versus XIENCE EES in 1.6% versus 1.4% (HR 1.15; 95% CI: 0.26-5.12; p = 0.86) and in males 3.9% versus 0.7% (HR 5.55; 95% CI: 2.11-14.35; p < 0.001). A statistical significant interaction between sex and device was present for TVF (p = 0.02), but was not seen for definite/probable device thrombosis (p = 0.08). CONCLUSIONS: In this subgroup analysis, Absorb BVS used in routine practice tends to result in better clinical outcomes in females compared to males.

Transcatheter aortic valve replacement for bicuspid aortic valve stenosis with first- and new-generation bioprostheses: A systematic review and meta-analysis.

BACKGROUND: Subjects with bicuspid aortic valve (BAV) have been excluded from transcatheter aortic valve replacement (TAVR) randomized trials. METHODS: With this meta-analysis of observational studies we first compared TAVR outcomes of BAV vs. tricuspid aortic valve (TAV) patients, stratifying the results by device generation. Then, we looked for differences between balloon-expandable (BE) and self-expandable (SE) bioprostheses in BAV patients. Primary outcome was 30-day mortality. Secondary outcomes were 30-day stroke, moderate-severe paravalvular leakage, new pacemaker implantation, vascular complications and 1-year mortality. RESULTS: Thirteen studies (11,032 patients, 7291 TAV and 3741 BAV) and seven studies (706 patients, 367 treated with BE, 339 with SE valve) met inclusion criteria. Thirty-day (OR = 1.13; 95% CI 0.88-1.46, p = 0.33) and 1-year mortality (OR = 1.02; 95% CI 0.77-1.37, p = 0.87) were similar between patients receiving TAVR for BAV or TAV. Subjects treated for BAV were at higher risk of conversion to conventional surgery (OR = 2.35; 95% CI 1.30-4.23, p = 0.005), implantation of a second valve (OR = 2.06; 95% CI 1.31-3.25; p = 0.002), moderate/severe paravalvular leakage (PVL) (OR = 1.67; 95% CI 1.29-2.17; p = 0.0001) and device failure (OR = 1.26; 95% CI 1.02-1.56; p = 0.04). Rates of adverse events decreased significantly with the use of new-generation devices, but outcome differences remained consistent. BAV patients treated with BE vs. SE valves had similar 30-day and 1-year mortality, stroke and moderate-severe PVL. Balloon-expandable valves were associated with lower rates of a second valve and new pacemaker implantation but carried higher risk of annular rupture. CONCLUSIONS: BAV patients treated with TAVR had similar 30-day and 1-year mortality as well as stroke and new pacemaker implantation rates compared to TAV subjects, but carried higher risk of moderate/severe PVL, conversion to surgery and device failure. Event rates significantly decreased with the use of new-generation devices, but TAVR still showed better procedural results in TAV compared to BAV.

Population trends in aortic valve surgery in Finland between 2001 and 2016.

Objectives. To investigate nationwide changes in procedure rates, patient selection, and prognosis after all surgical aortic valve replacements. Design. Patients undergoing primary surgical aortic valve replacement between 2001 and 2016 were identified from three nationwide registers with compulsory reporting to examine trends in aortic valve surgery over four four-year time periods. Results. A total of 12,139 surgical aortic valve replacement procedures (mean age 61.9 ± 11.8 years, 39.1% women) were performed. The total number of biological valves increased from 1001 (42.9%) to 2526 (75.5%) from 2001-2004 to 2013-2016 (p < .001). During the first and last time periods the comorbidity burden increased; share of patients with hypertension increased from 37.5% to 46.9% (p < .001), diabetes from 14% to 16.5% (p = .01) and previous stroke from 5.2% to 7.2% (p = .01). The proportion of women undergoing surgery decreased from 40% to 36.1% from 2001-2004 to 2013-2016, respectively (p = .01). Overall 28-day mortality was 3.5%. In patients with biologic valve the multivariable-adjusted risk of short-term mortality decreased steadily in every four-year period from 2001-2004 to 2005-2008 (HR, 0.66; 95% CI 0.47-9.92), 2009-2012 (HR, 0.54; 95% CI, 0.39-0.75) and 2013-2016 (HR, 0.41; 95% CI, 0.29-0.58), whereas short-term mortality remained similar in patients with mechanical valve. The risk of four-year postoperative mortality after all surgical aortic valve replacements stayed constant. Conclusions. The use of biologic aortic valve prosthesis has increased from 2001 to 2016. The proportion of women has declined markedly. The short-term mortality has decreased and the long-term mortality has stayed constant despite increasing comorbidity burden.

Treatment of failed aortic bioprostheses: An evaluation of conventional redo surgery and transfemoral transcatheter aortic valve-in-valve implantation.

BACKGROUND: The use of bioprostheses for surgical aortic valve replacement increased substantially within the last years. In case of prosthesis failure, re-SAVR is standard of care, whereas valve-in-valve deployment of a transfemoral transcatheter aortic valve prosthesis (VinV-TFAVI) has recently emerged as an alternative. We sought to evaluate early safety, clinical efficacy, and all-cause 1-year-mortality of VinV-TFAVI and redo surgery for failing aortic bioprostheses (re-SAVR). METHODS AND RESULTS: Patients receiving either VinV-TFAVI (n = 147) or re-SAVR (n = 111) for a degenerated aortic bioprosthesis between 01/2006 and 05/2017 were included in this analysis. All-cause 1-year mortality was the primary outcome measure. Early safety and clinical efficacy according to VARC-2 endpoint definitions were evaluated at 30 days. Baseline characteristics differed significantly between both groups including age, STS-PROM, and incidence of relevant comorbidities. Re-stenosis was the predominant mode of failure in 45.9% of re-SAVR and 63.1% of VinV-TFAVI patients. The rate of "early safety" endpoints was lower with VinV-TFAVI (17.7% vs. 64.9%, p < 0.01), the rate of "clinical efficacy" endpoints was lower, e.g. better with re-SAVR (53.1% vs. 32.4%, p < 0.01). All-cause 1-year-mortality (VinV-TFAVI 8.8% vs re-SAVR 9.9%, p = 0.84) was not different. Treatment strategy was not associated with 1-year-mortality in a Cox regression analysis. The incidence of prosthesis-patient-mismatch was higher in VinV-TFAVI compared to re-SAVR. CONCLUSION: VinV-TFAVI represents a viable alternative for treatment of degenerated aortic bioprostheses in patients at increased surgical risk. However, in patients at low risk for reoperation, a better clinical efficacy and acceptable safety may favour re-SAVR.

Trends, characteristics, in-hospital outcomes and mortality in surgical mitral valve replacement among patients with and without COPD in Spain (2001-2015).

PURPOSE: We examined trends, characteristics and in-hospital outcomes in mechanical and bioprosthetic surgical mitral valve replacement (SMVR) among patients with and without chronic obstructive pulmonary disease (COPD) in Spain from 2001 to 2015. We also identified factors associated with in-hospital mortality (IHM) in both groups of patients according to the implanted valve type. METHODS: We analyzed data from the Spanish National Hospital Discharge Database for patients aged 40 years or over. We selected admissions of patients whose medical procedures included SMVR. We grouped hospitalizations by COPD status. RESULTS: Over 43,024 patients identified, 83.63% underwent mechanical mitral valve replacement and 16.37% bioprosthetic valve (6.71% and 7.78% with COPD, respectively). The incidence of SMVR decreased for mechanical valves and increased for bioprosthetic valves over time in both groups of patients. The incidence of SMVR admissions was lower among COPD patients than in those without COPD, both for mechanical and bioprosthetic valves. IHM decreased significantly over time, regardless of the type of valve, in both groups of patients. COPD was associated with a significant increase in IHM, but only among patients who underwent bioprosthetic SMVR (OR 1.32, 95% CI 1.01-1.73). CONCLUSIONS: The incidence of mechanical SMVR decreased while that of bioprosthetic SMVR increased over time in both groups of patients. COPD patients were less surgically operated than non-COPD patients for both valve types. In COPD patients, bioprosthetic SMVR was proportionally more used than mechanical SMVR. Mortality decreased over time for both valve types in patients with and without COPD. COPD increased in-hospital mortality among patients undergoing a biological SMVR.

Long-term outcomes with balloon-expandable and self-expandable prostheses in patients undergoing transfemoral transcatheter aortic valve implantation for severe aortic stenosis.

BACKGROUND: Data on long-term outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) is scarce. METHODS: We investigated long term outcomes of consecutive patients undergoing TAVI with balloon- and self-expandable bioprostheses (Edwards SAPIEN (ESV), Edwards Lifesciences Inc., Irvine, CA, USA; Medtronic Corevalve system (MCS), Medtronic Inc., Minneapolis, MN, USA). RESULTS: Among 628 patients (mean age 82.4 ±â€¯5.8 years, 55% female), 489 (77.8%) underwent transfemoral TAVI. 309 (63.2%) patients received a MCS prosthesis, whereas 180 (36.8%) patients were treated with an ESV prosthesis. The median duration of follow-up amounted to 5.2 years (range 3.4-8.3 years). All-cause mortality did not differ between the two groups (MCS 46.9%, ESV 53.4%, CI 95%: RR 1.21 [0.93-1.57], P = 0.15), whereas cardiac mortality was higher in the ESV cohort after 5 years of follow-up (MCS 35.1%, ESV 45.4%, CI 95%: RR 1.37 [1.01-1.86], P = 0.04). Structural valve deterioration, which was on average diagnosed 41.9 months (range 18-60 months) after TAVI, occurred in 8 cases (1.6%), resulting in one repeat intervention. CONCLUSIONS: While half of all patients died within 5 years after TAVI with no significant differences in all-cause mortality, structural valve deterioration was documented in <2% of cases.

Durability Data for Bioprosthetic Surgical Aortic Valve: A Systematic Review.

Importance: Although several studies have reported data on surgical aortic valve durability, variability in study methodologies and definitions as well as inadequate follow-up make the interpretation of data from these studies difficult to interpret. Objective: To review available data on structural valve deterioration (SVD) of surgical bioprosthetic aortic valves by examining the published literature as well as data reported to the US Food and Drug Administration (FDA). Evidence Review: A systematic review using Preferred Reporting Items for Systematic Review and Meta-Analysis reporting guidelines to obtain all available data from preexisting literature on the actuarial freedom from SVD and outcomes of SVD. Data were collected from database inception to November 2016. Additionally, data reported to the FDA were obtained. Findings: In total, 167 studies and 12 FDA reports including 101 650 patients and 17 different valve types were analyzed. There were 11 different definitions of SVD used in the studies. Core laboratory data were available for 11 studies. Mean follow-up ranged from less than 1 year to 14 years. Kaplan-Meier estimates were reported for up to 30 years of follow-up, with 0% to 37% of patients remaining at risk at maximum follow-up. Food and Drug Administration-reported data are similarly variable in duration (mean follow-up range, 1.2 to 7 years) and completeness of follow-up, with final follow-up of 0.1% to 95%. Conclusions and Relevance: There is considerable variability in reporting SVD of surgical aortic valves, with different definitions and inadequate long-term systematically collected core laboratory data. Rigorously collected long-term data with standardized definitions for surgical valves are needed to provide a benchmark for the durability of rapidly evolving transcatheter valves.

Stroke After Surgical Versus Transfemoral Transcatheter Aortic Valve Replacement in the PARTNER Trial.

BACKGROUND: Transfemoral-transcatheter aortic valve replacement (TF-TAVR) is increasingly used to treat aortic stenosis, but risk of post-procedure stroke is uncertain. OBJECTIVES: The purpose of this study was to assess stroke risk and its association with quality of life after surgical aortic valve replacement (SAVR) versus TF-TAVR. METHODS: The authors performed a propensity-matched study of 1,204 pairs of patients with severe aortic stenosis treated with SAVR versus TF-TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valves) trials from April 2007 to October 2014. Outcomes were: 1) 30-day neurological events; 2) time-varying risk of neurological events early (≤7 days) and late (7 days to 48 months) post-procedure; and 3) association between stroke and quality of life 1 year post-procedure by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score. RESULTS: Thirty-day stroke (5.1% vs. 3.7%; p = 0.09) was similar, but 30-day major stroke (3.9% vs. 2.2%; p = 0.018) was lower after TF-TAVR than SAVR. In both groups, risk of stroke peaked in the first post-procedure day, followed by a near-constant low-level risk to 48 months. Major stroke was associated with a decline in quality of life at 1 year in both SAVR (KCCQ score median [15th, 85th percentile]: 79 [53, 94] without major stroke vs. 64 [30, 94] with major stroke; p = 0.03) and TF-TAVR (78 [49, 96] without major stroke vs. 60 [8, 99] with major stroke; p = 0.04). CONCLUSIONS: Despite similar early-peaking (<1 day post-procedure) neurological risk profiles, SAVR is associated with a higher risk of early major stroke than TF-TAVR. Periprocedural strategies are needed to reduce stroke risk after aortic valve procedures. (Placement of AoRTic TraNscathetER Valve Trial [PARTNER]; NCT00530894).

Impact of type 2 diabetes mellitus in the utilization and in-hospital outcomes of surgical aortic valve replacement in Spain (2001-2015).

BACKGROUND: The aims of this study were to examine trends in the incidence and in-hospital outcomes of SAVR among T2DM patients from 2001 to 2015, to compare clinical variables among T2DM patients and matched non-T2DM patients hospitalized for SAVR and to identify factors associated with in-hospital mortality (IHM) among T2DM patients. METHODS: We performed a retrospective study using the Spanish National Hospital Discharge Database, 2001-2015. We included patients who had SAVR as the procedure in their discharge report. For each T2DM patient, we selected a sex-, age-, implanted valve type- and year-matched nondiabetic patient. RESULTS: We identified 78,223 patients who underwent SAVR (23.49% with T2DM). The prevalence of T2DM increased significantly (p < 0.001) from 16.7% in 2001-2003 to 23.5% in 2012-2015. The incidence of SAVR increased significantly from 28.99 cases in 2001 to 65.79 cases in 2015 per 100,000 individuals in the T2DM population. Using Poisson regression models, we found that the incidence of SAVR was 2.60 times higher among patients with T2DM than among those without diabetes (IRR 2.60; 95% CI 2.56-2.65). The incidence of mechanical SAVR among T2DM patients remained stable from 2001 to 2015, and bioprosthetic SAVR rose from 8.29 to 41.74 cases per 100,000 individuals in the T2DM patient population (p < 0.001). We matched 8835 and 9543 patients who underwent mechanical and bioprosthetic SAVR, respectively. IHM decreased over time in T2DM patients and non-T2DM patients (from 8.89% and 7.81% to 3.88% and 5.07%, respectively). IHM was significantly lower in T2DM patients than in nondiabetic subjects who underwent bioprosthetic SAVR (4.77% vs. 6.04%, p < 0.001), with similar results obtained for mechanical valves (7.11% and 7.77%). CONCLUSIONS: The incidence of SAVR was higher in T2DM patients, and the incidence of bioprosthetic SAVR increased significantly among T2DM subjects. IHM decreased over time, regardless of the existence or absence of T2DM and the valve type. IHM was significantly lower in T2DM patients than in nondiabetic patients who underwent bioprosthetic SAVR.