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.

Drivers and outcomes of variation in surgical versus transcatheter aortic valve replacement in Ontario, Canada: a population-based study.

OBJECTIVES: To understand the patient and hospital level drivers of the variation in surgical versus trascatheter aortic valve replacement (SAVR vs TAVR) for patients with aortic stenosis (AS) and to explore whether this variation translates into differences in clinical outcomes. BACKGROUND: Adoption of TAVR has grown exponentially worldwide. Notwithstanding, a wide variation in TAVR rates has been seen within and between countries and in some jurisdictions AS is still primarily being managed by SAVR. METHODS: We conducted a population-based retrospective cohort study in Ontario, Canada, including individuals who received TAVR or SAVR between 2016 and 2020. We developed iterative hierarchical logistic regression models for the likelihood of receiving TAVR instead of SAVR examining sequentially patient characteristics, hospital factors and year of procedure, calculating the median ORs and variance partition coefficients for each. Using Cox proportional hazards models, we examined the relationship between TAVR/SAVR ratio on all-cause mortality and readmissions. RESULTS: Annual procedures rates per million population increased from 171 to 201, mainly driven by the expansion of TAVR. TAVR/SAVR ratios differed substantially between hospitals, from 0.21 to 3.27. Neither patient nor hospital factors explained the between-hospital variation in AS treatment. The TAVR/SAVR ratio was significantly associated with clinical outcomes with high ratio hospitals having lower mortality and rehospitalisations. CONCLUSIONS: Despite the expansion of TAVR, dramatic variation exists that is not explained by patient or hospital factors. This variation was associated with differences in clinical outcomes, suggesting that further work is needed in understanding and addressing inequity of access.

Results of transcarotid compared with transfemoral transcatheter aortic valve replacement.

OBJECTIVES: The femoral artery is the preferred vascular access to perform transcatheter aortic valve replacement (TAVR). However, the optimal alternative approach has not been elucidated in patients who are not candidates for a transfemoral (TF) access. The objective of this study was to compare the outcomes of TAVR performed by the transcarotid (TC) compared with the TF approach. METHODS: This was a single-center study that included 526 consecutive patients who underwent TAVR between 2015 and 2019. TC-TAVR was performed in 127 and TF-TAVR in 399 patients. Postprocedural and 30-day clinical events were evaluated according to main access (TC vs TF) using a multivariate logistic regression model. One-year survival and freedom from neurological events were also evaluated. RESULTS: The prevalence of diabetes, chronic obstructive pulmonary disease, coronary artery disease, and peripheral vascular disease was higher in the TC group. In-hospital mortality (3.2% vs 2.0%, adjusted odds ratio, 1.83; 95% confidence interval, 0.47-7.15; P = .39), and 30-day stroke (2.4% vs 3.3%; odds ratio, 0.84; 95% confidence interval, 0.21-3.41; P = .81), were similar between groups as were other outcomes: procedural success (98.4% vs 97.0%; P = .52), 30-day cumulative mortality (4.8% vs 2.8%; P = .26), major vascular complication (2.4% vs 4.5%; P = .25), and major/life-threatening bleeding (4.7% vs 6.0%; P = .41) (TC vs TF, respectively). No differences were found among groups regarding survival or neurological events at 1-year follow-up. CONCLUSIONS: The TC approach is a safe alternate-access strategy for TAVR, and is associated with similar outcomes compared with TF-TAVR, despite a higher disease burden in TC patients.

Introduction of transcatheter aortic valve replacement technology increases overall aortic valve surgical volume: Evaluating the Florida experience.

OBJECTIVE: Transcatheter aortic valve replacement technology is increasingly used for aortic valve stenosis. We sought to evaluate the adoption of transcatheter aortic valve replacement technology with respect to overall surgical aortic valve replacement volume in Florida. METHODS: The 2010-2019 Florida Agency for Health Care Administration data set was queried. Difference-in-difference analysis was used to evaluate the impact of transcatheter aortic valve replacement on the total aortic valve surgical volume of transcatheter aortic valve replacement versus nonperforming hospitals. Length of stay and elements of charges were compared for the raw and 1:1 propensity matched data. RESULTS: A total of 46,032 surgical aortic valve procedures were performed at 88 hospitals. Transcatheter aortic valve replacement performing hospitals experienced a 21% increase in total aortic valve surgical volume. Length of stay was significantly less for patients undergoing transcatheter aortic valve replacement. Propensity matched transcatheter aortic valve replacement patients had less gross total charges. CONCLUSION: Introduction of transcatheter aortic valve replacement technology significantly increased overall surgical aortic valve volume and may be associated with less gross total hospital charges.

The Impact of the COVID-19 Pandemic on Cardiac Procedure Wait List Mortality in Ontario, Canada.

BACKGROUND: The novel SARS-CoV-2 (COVID-19) pandemic has dramatically altered the delivery of healthcare services, resulting in significant referral pattern changes, delayed presentations, and procedural delays. Our objective was to determine the effect of the COVID-19 pandemic on all-cause mortality in patients awaiting commonly performed cardiac procedures. METHODS: Clinical and administrative data sets were linked to identify all adults referred for: (1) percutaneous coronary intervention; (2) coronary artery bypass grafting; (3) valve surgery; and (4) transcatheter aortic valve implantation, from January 2014 to September 2020 in Ontario, Canada. Piece-wise regression models were used to determine the effect of the COVID-19 pandemic on referrals and procedural volume. Multivariable Cox proportional hazards models were used to determine the effect of the pandemic on waitlist mortality for the 4 procedures. RESULTS: We included 584,341 patients who were first-time referrals for 1 of the 4 procedures, of whom 37,718 (6.4%) were referred during the pandemic. The pandemic period was associated with a significant decline in the number of referrals and procedures completed compared with the prepandemic period. Referral during the pandemic period was a significant predictor for increased all-cause mortality for the percutaneous coronary intervention (hazard ratio, 1.83; 95% confidence interval, 1.47-2.27) and coronary artery bypass grafting (hazard ratio, 1.96; 95% confidence interval, 1.28-3.01), but not for surgical valve or transcatheter aortic valve implantation referrals. Procedural wait times were shorter during the pandemic period compared with the prepandemic period. CONCLUSIONS: There was a significant decrease in referrals and procedures completed for cardiac procedures during the pandemic period. Referral during the pandemic was associated with increased all-cause mortality while awaiting coronary revascularization.

Dissemination of Transcatheter Aortic Valve Replacement in the United States.

BACKGROUND: Societal guidelines and payor coverage decisions for transcatheter aortic valve replacement (TAVR) attempt to strike a balance between providing access and maintaining quality. The extent to which dissemination of TAVR has achieved these ideals remains unknown. OBJECTIVES: This study sought to define patterns of TAVR dissemination in the United States and their influence on outcomes. METHODS: Using data from the TVT (Transcatheter Valvular Therapy) registry, this study identified TAVR sites from 2011 to 2018 and calculated drive-times from existing to new sites. In a contemporary cohort, this study compared site and patient characteristics by annual case volume and density of sites per million Medicare beneficiaries. Using hierarchical regression and Cox methods, this study determined the association between case volumes, site density, and changes in volume and density with patient risk profiles and outcomes. RESULTS: TAVR sites participating in the TVT registry increased from 198 to 556 from 2011 to 2018. Median drive-time from existing to new sites decreased from 403 minutes (interquartile range: 211-587 minutes) to 26 minutes (interquartile range: 17-48 minutes). In a contemporary cohort, higher site density was associated with lower procedural risk as well as with an increased hazard of 30-day risk-adjusted mortality (P = 0.017). Similarly, longitudinal increases in site density over time were associated with a higher hazard of 30-day (P = 0.011) and 1-year (P = 0.013) mortality. CONCLUSIONS: TAVR has expanded significantly over time, but with regional clustering of sites. Although procedural risk is lower at higher density sites, these sites demonstrate an increased hazard of mortality. These findings suggest that the expansion of TAVR services in the United States may have had unintended consequences on procedural quality.

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.

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.

Factors associated with a high or low implantation of self-expanding devices in TAVR.

OBJECTIVES: Optimizing valve implantation depth (ID) plays a crucial role in minimizing conduction disturbances and achieving optimal functional integrity. Until now, the impact of intraprocedural fast (FP) or rapid ventricular pacing (RP) on the implantation depth has not been investigated. Therefore, we aimed to (1) evaluate the impact of different pacing maneuvers on ID, and (2) identify the independent predictors of deep ID. METHODS: 473 TAVR patients with newer-generation self-expanding devices were retrospectively enrolled and one-to-one propensity-score-matching was performed, resulting in a matching of 189 FP and RP patients in each cohort. The final ID was analyzed, and the underlying functional, anatomical, and procedural conditions were evaluated by univariate and multivariate analysis. RESULTS: The highest ID was reached under RP in severe aortic valve calcification and valve size 26 mm. Multivariate analysis identified left ventricular outflow (LVOT) calcification [OR 0.50 (0.31-0.81) p = 0.005*], a "flare" aortic root [OR 0.42 (0.25-0.71), p = 0.001*], and RP (OR 0.49 [0.30-0.79], p = 0.004*) as independent highly preventable predictors of a deep ID. In a model of protective factors, ID was significantly reduced with the number of protective criteria (0-2 criteria: - 5.7 mm ± 2.6 vs. 3-4 criteria - 4.3 mm ± 2.0; p < 0.0001*). CONCLUSION: Data from this retrospective analysis indicate that RP is an independent predictor to reach a higher implantation depth using self-expanding devices. Randomized studies should prove for validation compared to fast and non-pacing maneuvers during valve delivery and their impact on implantation depth. TRAIL REGISTRATION: Clinical Trial registration: NCT01805739. STUDY DESIGN: Evaluation of the impact of different pacing maneuvers (fast ventricular pacing-FP vs. rapid ventricular pacing-RP) on implantation depth (ID). After one-to-one-propensity-score-matching, independent protective and risk factors for a very deep ID beneath 6 mm toward the LVOT (< - 6 mm) were identified. Stent frame pictures as a courtesy by Medtronic®. AVC aortic valve calcification.

Pacemaker dependency after transcatheter aortic valve replacement compared to surgical aortic valve replacement.

ABSTRACT: Transcatheter aortic valve replacement (TAVR) is a standard treatment indicated for severe aortic stenosis in high-risk patients. The objective of this study was to evaluate the incidence of pacemaker dependency after permanent pacemaker implantation (PPI) following TAVR or surgical aortic valve replacement (SAVR) and the risk of mortality at a tertiary center in Korea.In this retrospective study conducted at a single tertiary center, clinical outcomes related to pacemaker dependency were evaluated for patients implanted with pacemakers after TAVR from January 2012 to November 2018 and post-SAVR from January 2005 to May 2015. Investigators reviewed patients' electrocardiograms and baseline rhythms as well as conduction abnormalities. Pacemaker dependency was defined as a ventricular pacing rate > 90% with an intrinsic rate of <40 bpm during interrogation.Of 511 patients who underwent TAVR for severe AS, 37(7.3%) underwent PPI after a median duration of 6 (3-7) days, whereas pacemakers were implanted after a median interval of 13 (8-28) days post-SAVR in 10 of 663 patients (P < .001). Pacemaker dependency was observed in 36 (97.3%) patients during 7 days immediately post-TAVR and in 25 (64.9%) patients between 8 and 180 days post-TAVR. Pacemaker dependency occurred after 180 days in 17 (50%) patients with TAVR and in 4 (44.4%) patients with SAVR. Twelve (41.4%) patients were pacemaker-dependent after 365 days post-TAVR.Pacemaker dependency did not differ at 6 months after TAVR vs SAVR. In patients undergoing post-TAVR PPI, 58.6% were not pacemaker-dependent at 1 year after the TAVR procedure.

TAVR in patients with hip fracture and severe aortic stenosis: how and when?

Comorbidities are common in elderly patients with hip fracture and are associated with an increased mortality after surgery. Internal medicine/geriatric leaded multidisciplinary hip fracture teams may play a pivotal role in the clinical management of complex patients. Treatment strategy is particular relevant in patients with severe aortic stenosis that represent more than 5% of patients with hip fracture. These patients have a high in-hospital mortality and poor 1-year survival (less than 50%). Transcatheter aortic valve replacement (TAVR) may be an option in selected patients; however, the choice to treat and, in the case, the timing of valve replacement in relation to hip surgery is highly dependent on clinical conditions before trauma. In this paper, three different scenario of TAVR timing after hip fracture are reported.

Indirect Impact of the COVID-19 Pandemic on Activity and Outcomes of Transcatheter and Surgical Treatment of Aortic Stenosis in England.

[Figure: see text].

[Frailty, depression and prognosis after transcatheter aortic valve replacement: a review of the literature]. / Fragilité, dépression et pronostic après remplacement valvulaire aortique percutané : une revue de littérature.

A systematic review of the literature was conducted to analyze the results of studies evaluating the link between frailty and depression before percutaneous aortic valve replacement (TAVR) and vital prognosis and quality of life after TAVR. The literature indicates that TAVR is a procedure that improves quality of life for one year in older subjects, the longer-term effect being debated, possibly depending on the underlying comorbidities and their own course. The presence of depression before and after TAVR is associated with a lower quality of life before and after TAVR, suggesting to screen it systematically before and after TAVR. The underlying frailty of elderly patients eligible for TAVR is associated with excess mortality, justifying assessing before TAVR functional and cognitive reserves, and nutritional status of patients, especially. The link between depression before TAVR and excess mortality after TAVR is not clearly demonstrated and may in part be linked to apathy or impaired executive functions which can mimic depression and which should also be investigated before TAVR.

Baseline, procedural and outcome features of patients undergoing transcatheter aortic valve implantation according to different body mass index categories.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become first-line treatment for severe aortic valve stenosis in patients with moderate, high or prohibitive surgical risk. However, access site complications may occur more frequently in extreme body mass index (BMI) categories. The aim of this study was to describe the features and outcomes of patients undergoing TAVI in a comprehensive Italian prospective clinical registry, focusing on BMI classes. METHODS: A national prospective database was queried for baseline, procedural, and outcome details of patients undergoing TAVI according to established BMI categories: underweight (BMI <18.5 kg/m2), normal weight (BMI 18.5-24.9 kg/m2), overweight (BMI 25.0-29.9 kg/m2), and obese (BMI≥30 kg/m2). Short- and long-term outcomes, including major adverse events (MAE), i.e. the composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure, were appraised with bivariate and multivariable analyses. RESULTS: A total of 3075 subjects were included, 64 (2.1%) were underweight, 1319 (42.9%) were normal weight, 1152 (37.4%) were overweight, and 540 (17.6%) were obese. Several baseline differences were evident, including gender, diabetes mellitus, renal function, chronic obstructive pulmonary disease, surgical scores, and left ventricular ejection fraction (LVEF) (all P<0.05). Several procedural differences were also evident, including percutaneous approach, predilation, prosthesis type and size (all P<0.05), with postprocedural aortic regurgitation >2+ significantly more common in underweight patients (P<0.05). Nonetheless, unadjusted analysis for one-month outcomes showed similar rates for fatal and non-fatal outcomes, including MAE (all P>0.05), with the notable exception of permanent pacemaker implantation, which was more common in higher BMI classes (P=0.010) Unadjusted analysis for long-term events showed an increased rate of death in underweight patients (P=0.024). Multivariable adjusted analysis confirmed the increased risk of permanent pacemaker implantation in obese patients (P=0.015 when comparing obese vs. normal weight subjects), but disproved differences in long-term mortality and other outcomes (P>0.05 for all comparisons). CONCLUSIONS: Irrespective of BMI class, TAVI is associated with favorable outcomes in surgical high-risk risk patients, with the notable exclusion of permanent pacemaker implantation, which is significantly more common in obese subjects.

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.

Multivariate meta-analysis model for the difference in restricted mean survival times.

In randomized controlled trials (RCTs) with time-to-event outcomes, the difference in restricted mean survival times (RMSTD) offers an absolute measure of the treatment effect on the time scale. Computation of the RMSTD relies on the choice of a time horizon, $\tau$. In a meta-analysis, varying follow-up durations may lead to the exclusion of RCTs with follow-up shorter than $\tau$. We introduce an individual patient data multivariate meta-analysis model for RMSTD estimated at multiple time horizons. We derived the within-trial covariance for the RMSTD enabling the synthesis of all data by borrowing strength from multiple time points. In a simulation study covering 60 scenarios, we compared the statistical performance of the proposed method to that of two univariate meta-analysis models, based on available data at each time point and based on predictions from flexible parametric models. Our multivariate model yields smaller mean squared error over univariate methods at all time points. We illustrate the method with a meta-analysis of five RCTs comparing transcatheter aortic valve replacement (TAVR) with surgical replacement in patients with aortic stenosis. Over 12, 24, and 36 months of follow-up, those treated by TAVR live 0.28 [95% confidence interval (CI) 0.01 to 0.56], 0.46 (95% CI $-$0.08 to 1.01), and 0.79 (95% CI $-$0.43 to 2.02) months longer on average compared to those treated by surgery, respectively.

Added value of 18F-FDG-PET/CT and cardiac CTA in suspected transcatheter aortic valve endocarditis.

BACKGROUNDS: Transcatheter-implanted aortic valve infective endocarditis (TAVI-IE) is difficult to diagnose when relying on the Duke Criteria. Our aim was to assess the additional diagnostic value of 18F-fluorodeoxyglucose (18F-FDG) positron emission/computed tomography (PET/CT) and cardiac computed tomography angiography (CTA) in suspected TAVI-IE. METHODS: A multicenter retrospective analysis was performed in all patients who underwent 18F-FDG-PET/CT and/or CTA with suspected TAVI-IE. Patients were first classified with Duke Criteria and after adding 18F-FDG-PET/CT and CTA, they were classified with European Society of Cardiology (ESC) criteria. The final diagnosis was determined by our Endocarditis Team based on ESC guideline recommendations. RESULTS: Thirty patients with suspected TAVI-IE were included. 18F-FDG-PET/CT was performed in all patients and Cardiac CTA in 14/30. Using the Modified Duke Criteria, patients were classified as 3% rejected (1/30), 73% possible (22/30), and 23% definite (7/30) TAVI-IE. Adding 18F-FDG-PET/CT and CTA supported the reclassification of 10 of the 22 possible cases as "definite TAVI-IE" (5/22) or "rejected TAVI-IE" (5/22). This changed the final diagnosis to 20% rejected (6/30), 40% possible (12/30), and 40% definite (12/30) TAVI-IE. CONCLUSIONS: Addition of 18F-FDG-PET/CT and/or CTA changed the final diagnosis in 33% of patients and proved to be a valuable diagnostic tool in patients with suspected TAVI-IE.

How low is "low-flow" in aortic stenosis? A retrospective analysis of patients with true low-flow/low-gradient aortic stenosis undergoing TAVI.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a valuable treatment option for patients with reduced left ventricular ejection fraction (LVEF) and low-flow/low-gradient (LF/LG) aortic stenosis (AS). According to current literature, the presence of severe AS is unlikely in case of severely reduced LVEF and mean pressure gradient (meanPG) below 30 mmHg. However, a considerable number of patients presenting with typical clinical symptoms of severe AS, show gradients below 30 mmHg. We hypothesized, that these patients undergoing TAVI do have a measurable clinical benefit and an improved LVEF. METHODS: In this single center retrospective cohort study, data from 1199 patients undergoing TAVI between 2013 and 2017 was analyzed. A 6-month follow-up was performed to assess changes in NT-proBNP, NYHA-class, and LVEF. RESULTS: Thirty patients presented with LVEF<35%, an aortic valve area (AVA<1 cm2), and a meanPG below 30 mmHg. Mean logistic EuroSCORE II was 24.05±10.9. Most patients (56%) showed improved NYHA-class upon follow-up. NT-proBNP-levels decreased from 3.901 pg/mL IQR 10.880 to 1.491 pg/mL IQR 2.245 (P<0.001). LVEF increased from 30% IQR 6.25 to 40% IQR 15 (P<0.001). CONCLUSIONS: Based on our findings TAVI represents a valuable treatment option even in patients with LF/LG AS and PGmean below 30mmHg.

Catheterization laboratory activity before and during COVID-19 spread: A comparative analysis in Piedmont, Italy, by the Italian Society of Interventional Cardiology (GISE).

BACKGROUND: COronaVIrus Disease 19 (COVID-19) led to the reorganization of Cardiology Units in terms of working spaces and healthcare personnel. In this scenario, both outpatient visits and elective interventional cardiology procedures were suspended and/or postponed. We aimed to report the impact of COVID-19 on interventional coronary and structural procedures in Piedmont, Italy. METHODS: The number of coronary angiographies (CAG), percutaneous coronary interventions (PCI), primary PCI (pPCI), transcatheter aortic valve replacements (TAVR) and Mitraclip performed in Piedmont between March 1st and April 20th, 2020 (CoV-time) were collected from each catheterization laboratory and compared to the number of procedures performed the year before in the same months (NoCoV-time). RESULTS: Procedural data from 18 catheterization laboratories were collected. Both coronary (5498 versus 2888: difference: -47.5%; mean 305.4 VS 160.4; p = 0.002) and structural (84 versus 17: difference: -79.8%; mean 4.7 Vs 0.9; p < 0.001) procedures decreased during CoV-time compared to NoCoV-time. In particular, coronary angiographies (1782 versus 3460), PCI (1074 versus 1983), p PCI (271 versus 410), TAVR (11 versus 72) and Mitraclip (6 versus 12) showed a reduction of 48.5%, 45.7%, 33.7%, 84.7% and 50.0%, respectively (all p for comparison <0.05). CONCLUSIONS: Compared to the same time-period in 2019, both coronary and structural interventional procedures during COVID-19 epidemic suffered a dramatic decrease in Piedmont, Italy. Organizational change and structured clinical pathways should be created, together with awareness campaigns.