Prognostic Impact of Prefrailty and Frailty in Women Undergoing TAVR: Insights From the WIN-TAVI Registry.

BACKGROUND: The risks of prefrail and frail women undergoing transcatheter aortic valve replacement (TAVR) have not been fully examined. The aim of the analysis was to assess the prognostic impact of prefrailty and frailty in women undergoing TAVR. METHODS: Women at intermediate or high surgical risk with severe aortic stenosis undergoing TAVR from the prospective multicentre WIN-TAVI (Women's International Transcatheter Aortic Valve Implantation) registry were stratified based on the number of Fried frailty criteria (weight loss, exhaustion, low physical activity, slow gait, weakness) met: nonfrail (no criteria), prefrail (1 or 2 criteria), or frail (3 or more criteria). The primary outcome at 1 year was the Valve Academic Research Consortium 2 (VARC-2) efficacy end point, a composite of mortality, stroke, myocardial infarction, hospitalisation for valve-related symptoms or heart failure, and valve-related dysfunction; secondary outcomes included the composite of VARC-2 life-threatening or major bleeding. RESULTS: Out of 1019 women, 297 (29.1%) met at least 1 frailty criterion: 264 (25.9%) had prefrailty and 33 (3.2%) frailty. The 1-year risk of the primary outcome was significantly higher in prefrail and frail (20.2%) than in nonfrail (14.9%) women (adjusted hazard ratio [aHR] 1.51, 95% confidence interval [CI] 1.07-2.12). The risk of VARC-2 life-threatening or major bleeding was higher in prefrail or frail (19.9%) than in nonfrail (10.0%) women (aHR 2.06, 95% CI 1.42-2.97). These risks were consistently increased in the prefrail and frail groups assessed separately. CONCLUSIONS: In women undergoing TAVR, the presence of prefrailty or frailty conferred an increased risk of the VARC-2 efficacy end point and of VARC-2 life-threatening or major bleeding.

Clinical and Hemodynamic Outcomes of Balloon-Expandable Mitral Valve-in-Valve Positioning and Asymmetric Deployment: The VIVID Registry.

BACKGROUND: Mitral valve-in-valve (ViV) is associated with suboptimal hemodynamics and rare left ventricular outflow tract (LVOT) obstruction. OBJECTIVES: This study aimed to determine whether device position and asymmetry are associated with these outcomes. METHODS: Patients undergoing SAPIEN 3 (Edwards Lifesciences) mitral ViV included in the VIVID (Valve-in-Valve International Data) Registry were studied. Clinical endpoints are reported according to Mitral Valve Academic Research Consortium definitions. Residual mitral valve stenosis was defined as mean gradient ≥5 mm Hg. Depth of implantation (percentage of transcatheter heart valve [THV] atrial to the bioprosthesis ring) and asymmetry (ratio of 2 measures of THV height) were evaluated. RESULTS: A total of 222 patients meeting the criteria for optimal core lab evaluation were studied (age 74 ± 11.6 years; 61.9% female; STS score = 8.3 ± 7.1). Mean asymmetry was 6.2% ± 4.4%. Mean depth of implantation was 19.0% ± 10.3% atrial. Residual stenosis was common (50%; mean gradient 5.0 ± 2.6 mm Hg). LVOT obstruction occurred in 7 cases (3.2%). Implantation depth was not a predictor of residual stenosis (OR: 1.19 [95% CI: 0.92-1.55]; P = 0.184), but more atrial implantation was protective against LVOT obstruction (0.7% vs 7.1%; P = 0.009; per 10% atrial, OR: 0.48 [95% CI: 0.24-0.98]; P = 0.044). Asymmetry was found to be an independent predictor of residual stenosis (per 10% increase, OR: 2.30 [95% CI: 1.10-4.82]; P = 0.027). CONCLUSIONS: Valve stenosis is common after mitral ViV. Asymmetry was associated with residual stenosis. Depth of implantation on its own was not associated with residual stenosis but was associated with LVOT obstruction. Technical considerations to reduce postdeployment THV asymmetry should be considered.

Outcomes of Patients With Very Severe Aortic Stenosis Treated With Transcatheter Aortic Valve Implantation.

Symptoms of aortic stenosis (AS) are not proportional to its severity and patients with very severe AS (VSAS) remain asymptomatic for a long time. The appropriate time for intervention in patients with VSAS and the effects of transcatheter aortic valve implantation (TAVI) on left ventricular hypertrophy (LVH) remain debated. Our aim was to compare the procedural and 30-day outcomes of TAVI between patients with VSAS and patients with severe AS (SAS) and the changes in LVH. We selected patients with an aortic peak velocity ≥5 m/s (VSAS) and those with aortic peak velocity 4 to 5 m/s (SAS) treated with TAVI. Patients with reduced left ventricular ejection fraction (<45%) were excluded. The primary end point was the incidence of all-cause death at 30 days. The secondary end points included the 30-day incidence of cardiac death, cardiac rehospitalization, and stroke/transient ischemic attack and the changes in LVH from baseline to 30 days. A total of 102 patients in the VSAS group and 535 in the SAS group were included. Patients in the VSAS group had a thicker septal wall (p <0.001) and a higher Agaston score (p <0.001) and calcium volume (p = 0.007). No differences were observed regarding the primary and secondary clinical end points. However, patients with VSAS showed a significantly greater improvement in concentric LVH, although the prevalence of concentric LVH remained higher than in patients with SAS. TAVI in patients with VSAS showed similar procedural and clinical outcomes to patients with SAS and experienced a more pronounced improvement in the prevalence of concentric LVH.

Comparison of different percutaneous revascularisation timing strategies in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: The optimal timing to perform percutaneous coronary interventions (PCI) in transcatheter aortic valve implantation (TAVI) patients remains unknown. AIMS: We sought to compare different PCI timing strategies in TAVI patients. METHODS: The REVASC-TAVI registry is an international registry including patients undergoing TAVI with significant, stable coronary artery disease (CAD) at preprocedural workup. In this analysis, patients scheduled to undergo PCI before, after or concomitantly with TAVI were included. The main endpoints were all-cause death and a composite of all-cause death, stroke, myocardial infarction (MI) or rehospitalisation for congestive heart failure (CHF) at 2 years. Outcomes were adjusted using the inverse probability treatment weighting (IPTW) method. RESULTS: A total of 1,603 patients were included. PCI was performed before, after or concomitantly with TAVI in 65.6% (n=1,052), 9.8% (n=157) or 24.6% (n=394), respectively. At 2 years, all-cause death was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (6.8% vs 20.1% vs 20.6%; p<0.001). Likewise, the composite endpoint was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (17.4% vs 30.4% vs 30.0%; p=0.003). Results were confirmed at landmark analyses considering events from 0 to 30 days and from 31 to 720 days. CONCLUSIONS: In patients with severe aortic stenosis and stable coronary artery disease scheduled for TAVI, performance of PCI after TAVI seems to be associated with improved 2-year clinical outcomes compared with other revascularisation timing strategies. These results need to be confirmed in randomised clinical trials.

Vascular Access in Patients With Peripheral Arterial Disease Undergoing TAVR: The Hostile Registry.

BACKGROUND: The optimal access route in patients with severe peripheral artery disease (PAD) undergoing transcatheter aortic valve replacement (TAVR) remains undetermined. OBJECTIVES: This study sought to compare clinical outcomes with transfemoral access (TFA), transthoracic access (TTA), and nonthoracic transalternative access (TAA) in TAVR patients with severe PAD. METHODS: Patients with PAD and hostile femoral access (TFA impossible, or possible only after percutaneous treatment) undergoing TAVR at 28 international centers were included in this registry. The primary endpoint was the propensity-adjusted risk of 30-day major adverse events (MAE) defined as the composite of all-cause mortality, stroke/transient ischemic attack (TIA), or main access site-related Valve Academic Research Consortium 3 major vascular complications. Outcomes were also stratified according to the severity of PAD using a novel risk score (Hostile score). RESULTS: Among the 1,707 patients included in the registry, 518 (30.3%) underwent TAVR with TFA after percutaneous treatment, 642 (37.6%) with TTA, and 547 (32.0%) with TAA (mostly transaxillary). Compared with TTA, both TFA (adjusted HR: 0.58; 95% CI: 0.45-0.75) and TAA (adjusted HR: 0.60; 95% CI: 0.47-0.78) were associated with lower 30-day rates of MAE, driven by fewer access site-related complications. Composite risks at 1 year were also lower with TFA and TAA compared with TTA. TFA compared with TAA was associated with lower 1-year risk of stroke/TIA (adjusted HR: 0.49; 95% CI: 0.24-0.98), a finding confined to patients with low Hostile scores (Pinteraction = 0.049). CONCLUSIONS: Among patients with PAD undergoing TAVR, both TFA and TAA were associated with lower 30-day and 1-year rates of MAE compared with TTA, but 1-year stroke/TIA rates were higher with TAA compared with TFA.

Outcomes in Patients With Early Menopause Who Underwent Transcatheter Aortic Valve Implantation.

Early menopause is associated with an increased risk of cardiovascular diseases, including aortic stenosis (AS). We sought to investigate the prevalence and impact of early menopause on clinical outcomes in patients who underwent transcatheter aortic valve implantation (TAVI) for severe symptomatic AS. Women's International TAVI is a multinational, prospective, observational registry of women who underwent TAVI for severe symptomatic AS (n = 1,019). Patients were divided into 2 groups based on age of menopause: early menopause (age ≤45 years) and regular menopause (age >45 years). The primary outcome of interest was Valve Academic Research Consortium 2 efficacy end point, a composite of mortality, stroke, myocardial infarction, hospitalization for valve-related symptoms, or heart failure or valve-related dysfunction at 1-year follow-up. Of 732 patients with available data on menopause age, 173 (23.6%) were classified as having early menopause. These patients presented for TAVI at a younger age (81.6 ± 6.9 vs 82.7 ± 5.9, p = 0.05) and had a significantly lower Society of Thoracic Surgeons score (6.6 ± 4.8 vs 8.2 ± 7.1, p = 0.03) than those with regular menopause. However, the total valve calcium volume was smaller among patients with early versus regular menopause (731.8 ± 850.9 mm3 vs 807.6 ± 633.8 mm3, p = 0.002). Other co-morbidities were similar between the 2 groups. At 1-year follow-up, there were no significant differences in clinical outcomes between patients with early versus regular menopause (hazard ratio 1.00, 95% confidence interval 0.61 to 1.63, p = 1.00). In conclusion, despite presenting for TAVI at a younger age, patients with early menopause had a similar risk of adverse events as patients with regular menopause at 1 year after TAVI.

Four-year outcomes of a single-center experience with coronary everolimus-eluting bioresorbable scaffolds.

BACKGROUND: Bioresorbable scaffolds (BRS) have been introduced to overcome the limitations of drug-eluting stents and the ABSORB (Everolimus-Eluting BRS, Abbott Vascular, Santa Clara, CA, USA) was the most extensively tested. Nevertheless, major RCTs reported higher rates of target lesion failures and BRS thrombosis at 3 years follow-up, bringing to the withdrawing of the device from the market. It has been suggested that a better lesions selection and an optimized implantation technique could mitigate the displayed adverse results. METHODS: Consecutive patients undergoing BRS implantation were included in this observational, single center study. Clinical follow-up was conducted up to 4 years. Endpoint of interest was the target lesion failure (TLF), a composite outcome including cardiac death, target vessel myocardial infarction and target lesion revascularization. RESULTS: A total of 62 patients with a mean age of 55±8.5 years were analyzed of which 70.9% presented with an acute coronary syndrome and 59.6% with myocardial infarction. A total of 100 lesions were treated and 51.6% were complex (B2/C). Predilatation was performed in all the case, post-dilatation in 74.1%. All the target vessel reference diameter (RVD) were >2.5 mm (average RVD 3.2±0.24 mm). At 4 years, the rate for TLF was 6.9%. Subgroup's analysis did not show significative differences among groups although consistently higher event rates were found for RVD <2.5 mm (12.6% vs. 6.4%, P=0.5), BRS overlapping (11.8% vs. 5%, P=0.2) and ticagrelor instead of clopidogrel on top of cardioaspirin (9.1% vs. 3%, P=0.2). CONCLUSIONS: This small-sized real-world registry displays lower rates of clinical events during long-term follow-up in respect to previous studies. The avoidance of implantation in small vessels, inclusion of acute myocardial infarction and extensive performance of BRS post-dilatation could explain the observed better results. Long-term outcomes of the ongoing ABSORB IV Trial are needed to confirm this data.

Pre-procedural oral anticoagulant use is associated with cardiovascular events in women after transcatheter aortic valve replacement: An analysis from the WIN-TAVI cohort.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become an accepted treatment for patients with severe aortic stenosis (AS). Predicting which patients are at risk for adverse clinical outcomes after TAVI remains difficult, especially in women. AIM: To identify predictors of adverse events in the WIN-TAVI cohort. METHODS: The WIN-TAVI study is an observational registry of 1019 women undergoing TAVI for severe symptomatic AS. Follow-up was 1 year. The primary outcome was defined according to VARC-2: a composite of mortality, stroke, myocardial infarction or hospitalization for valve-related symptoms or heart failure. The secondary outcome was a composite of cardiovascular mortality or hospitalization for valve-related symptoms or heart failure. RESULTS: We included 1019 women with severe AS (mean age of 82.5 ± 6.3 years). At 1 year, 16.4% of the patients experienced the primary endpoint and 12.6% the secondary endpoint. The use of oral anticoagulants (OAC) was the strongest independent predictor of the primary outcome (adjusted hazard ratio [aHR] 1.51, 95% confidence interval [CI] 1.079-2.106, p = 0.016). Independent predictors of the secondary endpoint were age (aHR 1.04 per year, 95% CI 1.01-1.074, p = 0.016) and use of OAC (aHR: 1.79, 95% CI 1.24-2.60, p = 0.002). OAC use was not associated with higher bleeding risk. CONCLUSION: Pre-procedural use of OAC was the strongest predictor of adverse outcomes during 1-year follow-up, likely reflecting a combination of high-risk factors and comorbidities, but was not related to increased bleeding risk.

Management of Myocardial Revascularization in Patients With Stable Coronary Artery Disease Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: The best management of stable coronary artery disease (CAD) in patients undergoing transcatheter aortic valve implantation (TAVI) is still unclear due to the marked inconsistency of the available evidence. METHODS: The REVASC-TAVI registry (Management of Myocardial Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation With Coronary Artery Disease) collected data from 30 centers worldwide on patients undergoing TAVI who had significant, stable CAD at preprocedural work-up. For the purposes of this analysis, patients with either complete or incomplete myocardial revascularization were compared in a propensity score matched analysis, to take into account of baseline confounders. The primary and co-primary outcomes were all-cause death and the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure, respectively, at 2 years. RESULTS: Among 2407 patients enrolled, 675 pairs of patients achieving complete or incomplete myocardial revascularization were matched. The primary (21.6% versus 18.2%, hazard ratio' 0.88 [95% CI, 0.66-1.18]; P=0.38) and co-primary composite (29.0% versus 27.1%, hazard ratio' 0.97 [95% CI, 0.76-1.24]; P=0.83) outcome did not differ between patients achieving complete or incomplete myocardial revascularization, respectively. These results were consistent across different prespecified subgroups of patients (< or >75 years of age, Society of Thoracic Surgeons score > or <4%, angina at baseline, diabetes, left ventricular ejection fraction > or <40%, New York Heart Association class I/II or III/IV, renal failure, proximal CAD, multivessel CAD, and left main/proximal anterior descending artery CAD; all P values for interaction >0.10). CONCLUSIONS: The present analysis of the REVASC-TAVI registry showed that, among TAVI patients with significant stable CAD found during the TAVI work-up, completeness of myocardial revascularization achieved either staged or concomitantly with TAVI was similar to a strategy of incomplete revascularization in reducing the risk of all cause death, as well as the risk of death, stroke, myocardial infarction, and rehospitalization for heart failure at 2 years, regardless of the clinical and anatomical situations.

Correlation of left ventricular myocardial work indices with invasive measurement of stroke work in patients with advanced heart failure.

Objectives: This study aimed to explore the correlation between left ventricular (LV) myocardial work (MW) indices and invasively-derived LV stroke work index (SWI) in a cohort of patients with advanced heart failure (AHF) considered for heart transplantation. Background: Left ventricular MW has emerged as a promising tool for diagnostic and prognostic purposes in heart failure (HF) but its relationship with hemodynamic data derived from right heart catheterization (RHC) has not been assessed in patients with advanced heart failure yet. Materials and methods: Consecutive patients with AHF considered for heart transplantation from 2016 to 2021 performing RHC and echocardiography as part of the workup were included. Conventional LV functional parameters and LV MW indices, including LV global work index (GWI), LV global constructive work (GCW), LV global wasted work (GWW), LV global work efficiency (GWE), and other were calculated and compared with invasively-measured LV SWI. Results: The population included 44 patients. Median time between RHC and echocardiography was 0 days (IQR: 0-24). Median age was 60 years (IQR: 54-63). For the most part, etiology of HF was non-ischemic (61.4%) and all patients were either on class NYHA II (61.4%) or III (27.3%). Median left ventricular ejection fraction was 25% (IQR: 22.3-32.3), median NT-proBNP 1,377 pg/ml (IQR: 646-2570). LV global longitudinal strain (GLS) significantly correlated with LV SWI (r = -0.337; p = 0.031), whereas, LV ejection fraction (EF) did not (r = 0.308; p = 0.050). With regard to LV MW indices, some of them demonstrated correlation with LV SWI, particularly LV GWI (r = 0.425; p = 0.006), LV GCW (r = 0.506; p = 0.001), LV global positive work (LV GPW; r = 0.464; p = 0.003) and LV global systolic constructive work (GSCW; r = 0.471; p = 0.002). Conclusion: Among LV MW indices, LV GCW correlated better with invasively-derived SWI, potentially representing a powerful tool for a more comprehensive evaluation of myocardial function.

Prognostic value of right ventricle to pulmonary artery coupling in transcatheter aortic valve implantation recipients.

AIMS: To investigate the impact of the right ventricle to pulmonary artery (RV-PA) coupling on the outcome of patients undergoing transcatheter aortic valve intervention (TAVI), and to describe changes in right ventricular function, pulmonary hypertension, and their ratio after TAVI. METHODS: Three hundred and seventy-seven patients from the Italian ClinicalService Project, who underwent TAVI between February 2011 and August 2020, were included. Tricuspid annular plane systolic excursion/pulmonary artery systolic pressure (TAPSE/PASP) ratio was retrospectively calculated as a surrogate of RV-PA coupling. The population was stratified according to TAPSE/PASP using a cut-off of 0.36 mm/mmHg derived from a receiving operating characteristic (ROC) curve. The primary end point was 6-month all-cause death. RESULTS: Compared with patients with a TAPSE/PASP ratio ≥0.36 mm/mmHg (81%), those with TAPSE/PASP ratio <0.36 mm/mmHg (19%) had more comorbidities and were more symptomatic.Moreover, they were more likely to receive general anesthesia and an old generation device. Device success was similar between the two groups. A TAPSE/PASP ratio <0.36 mm/mmHg was associated with a higher risk of all-cause death at 6-months (17.3% versus 5.3%; adjusted HR 2.66; P = 0.041). The prognostic impact of the TAPSE/PASP ratio was stronger than the impact of TAPSE and PASP as separate parameters and was independent of the surgical risk score. Both TAPSE, PASP, and their ratio improved from baseline to 1 month and 6 months after TAVI. CONCLUSIONS: A TAPSE/PASP ratio <0.36 mm/mmHg is strongly associated with an increased risk of mortality after TAVI. Providing a left ventricle unloading, TAVI is associated with improvement of both TAPSE, PASP, and their ratio.

Predictors of early discharge after transcatheter aortic valve implantation: insight from the CoreValve ClinicalService.

AIMS: The aim of this study was to minimize the procedure, and reduce the length of hospital stay (LoS) is the future objective for transcatheter aortic valve replacement (TAVI).Aims of the study are to identify procedural and electrocardiographical predictors of fast-track discharge in patients who underwent TAVI. METHODS: Patients treated with TAVI included in the One Hospital ClinicalService project were categorized according to the LoS. 'Fast-Track' population, with a postprocedural LoS less than or equal to 3 days, was compared with the 'Slow-Track' population with a postprocedural LoS greater than 3 days. RESULTS: One thousand five hundred and one patients were collected. Despite single baseline characteristics being almost similar between the two groups, Slow-Track group showed a higher surgical risk (P < 0.001). Patients in the Slow-Track group were more frequently treated with general anaesthesia (P = 0.002) and less frequently predilated (P < 0.001) and received a lower amount of contrast media. No difference between Slow-Track and Fast-Track patients was observed at 30 days in death and in cardiovascular rehospitalization.In the multivariable analysis, STS score of at least 4% [odds ratio (OR): 1.64; P = 0.01], general anaesthesia (OR: 2.80; P = 0.03), predilation (OR: 0.45; P < 001), NYHA 3-4 at baseline (OR: 1.65; P = 0.01), AVB I/LBBB/RBBB onset (OR: 2.41; P < 0.001) and in-hospital new PM (OR: 2.63; P < 0.001) were independently associated with a higher probability of Slow-Track. CONCLUSION: Fast-Track patients were safely discharged home showing no difference in clinical outcomes after discharge up to 30 days compared with the Slow-Track group. The STS score, general anaesthesia, NYHA 3--4 at baseline, in-hospital onset of conduction disturbances and new PM implantation after TAVI turned out to be predictors of Slow-Track.

Transcatheter Aortic Valve Replacement for Mixed Aortic Valve Disease: A Propensity Score-Adjusted Analysis From the RISPEVA Registry.

BACKGROUND: The differential outcomes between pure/predominant aortic stenosis (AS) and mixed aortic valve disease (MAVD) in patients undergoing transcatheter aortic valve implantation (TAVI) are still debated. OBJECTIVE: To evaluate the comparative clinical outcomes of patients with MAVD and AS undergoing TAVI using data from the RISPEVA registry. METHODS: A total of 3263 patients were included. Of the 3263 patients, 656 with concomitant moderate/severe aortic regurgitation constituted the MAVD group and 2607 constituted the AS cohort. Primary endpoints were 30-day mortality and 1-year survival. Postprocedural paravalvular regurgitation (PPVR), cerebrovascular events, bleeding, and vascular complications were assessed at 30 days. RESULTS: In the overall population, 30-day mortality in the MAVD group was higher than in AS patients (4.3% vs 2.6%;P=.02); however, no differences were detected after propensity-score matching (4.1% vs 3.5%; P=.62). One-year survival was comparable between MAVD and AS patients in both unmatched and matched cohorts. Left ventricular ejection fraction, pulmonary artery systolic pressure, and PPVR, but not baseline MAVD, were predictors of 30-day mortality. The incidence of PPVR was higher in the MAVD group vs the AS group; this difference was not confirmed in patients implanted with a balloon-expandable device. CONCLUSION: MAVD per se did not negatively affect patients' prognoses, but appears to identify a more complex cohort of patients with a worse clinical and functional status, probably referred to TAVI in a later stage of the disease. Patients with MAVD had a greater propensity to develop PPVR, which is a known predictor of worse outcome; this tendency seems to be mitigated by the implantation of balloon-expandable valves.

Impact of Small Valve Size on 1-Year Outcomes After Transcatheter Aortic Valve Implantation in Women (from the WIN-TAVI Registry).

Although most patients with small aortic annulus are women, there is paucity of data on the prognostic impact of small aortic prosthesis in women who underwent transcatheter aortic valve implantation (TAVI). Therefore, we aimed to evaluate the impact of small valve size on 1-year clinical outcomes after TAVI in women. The Women's INternational Transcatheter Aortic Valve Implantation is an all-women registry evaluating patients with severe aortic stenosis who underwent TAVI. Based on the size of the aortic bioprosthesis implanted, women were stratified into small (≤23 mm) and nonsmall (>23 mm) valve. The primary efficacy endpoint was the Valve Academic Research Consortium-2 composite of all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up. Of 934 women who underwent TAVI, 388 (41.5%) received a small valve. Women with a small valve size had a lower body mass index, lower surgical risk scores, were less likely to suffer from atrial fibrillation, less often required postdilation and had a lower rate of residual aortic regurgitation grade ≥2. The occurrence of the Valve Academic Research Consortium-2 efficacy endpoint was similar between women treated with small and nonsmall valve (16.0% vs 16.3%, p = 0.881; adjusted hazard ratio 1.34, 95% confidence interval 0.90 to 2.00). Likewise, there were no significant differences in the occurrence of other secondary endpoints after multivariable adjustment. In conclusion, women with severe aortic stenosis who underwent TAVI with the implantation of a small valve bioprosthesis had similar 1-year outcomes as those receiving a nonsmall bioprosthesis.

Valve-in-Valve Implantation of Medtronic CoreValve Prosthesis in Patients With Failing Bioprosthetic Aortic Valves: Mid-term Outcomes From the Italian CoreValve Clinical Service Project.

OBJECTIVES: We evaluated the acute and two-year safety and efficacy of using the Corevalve, Evolut R, and Evolut PRO valves for treating failed surgical bioprosthesis from the Italian CoreValve Clinical Service Project. BACKGROUND: Valve-in-valve (ViV) TAVR is an emerging treatment option for failed surgical bioprosthesis. Choice of transcatheter valve is an important determinant of procedural and clinical outcomes, however, longer-term data are lacking. METHODS: The Clinical Service Project is a national clinical data repository evaluating the use of implantable devices across Italy. The present multi-center analysis includes consecutive patients who underwent ViV-TAVR with the Medtronic CoreValve series between October 2008 to June 2019. Evaluated endpoints included rates of overall mortality, cardiovascular mortality, myocardial infarction, and cerebrovascular accidents at 2-year follow-up. Procedural success, complications, and echocardiographic outcomes were reported according to VARC-2 criteria. RESULTS: A total of 139 patients (mean age, 80 ± 7 years; 47.5% male; mean STS score, 10.0 ± 9.7%) underwent ViV-TAVR with CoreValve (28.5%), Evolut R (68.6%), and Evolut Pro (2.9%) valves. Device success was achieved in 68% and acute coronary obstruction requiring PCI was observed in 4 patients (2.9%). Moderate PVL was observed in 3.7% and 2.8% of patients at 30-day and 2-year follow-up and moderate structural valve degeneration seen only 5 patients (3.6%). All-cause and cardiovascular mortality were 3.6% and 2.9% at 30 days, respectively, and 20.6% and 10.2% at 2-year follow-up. CONCLUSIONS: This real-world nationwide analysis demonstrates the acute and longer-term safety and efficacy of using the self-expanding Medtronic THV for ViV-TAVR.

Impact of High Body Mass Index on Vascular and Bleeding Complications After Transcatheter Aortic Valve Implantation.

Increased body mass index (BMI) is an established cardiovascular risk factor. The impact of high BMI on vascular and bleeding complications in patients undergoing transcatheter aortic valve implantation (TAVI) is not clarified. RISPEVA, a multicenter prospective database of patients undergoing TAVI stratified by BMI was used for this analysis. Patients were classified as normal or high BMI (obese and overweight) according to the World Health Organization criteria. A comparison of 30-day vascular and bleeding outcomes between groups was performed using propensity scores methods. A total of 3776 matched subjects for their baseline characteristics were included. Compared with normal BMI, high BMI patients had significantly 30-day greater risk of the composite of vascular or bleeding complications (11.1% vs 8.8%, OR: 1.28, 95% CI [1.02 to 1.61]; p = 0.03). Complications rates were higher in both obese (11.3%) and overweight (10.5%), as compared with normal weight patients (8.8%). By a landmark event analysis, the effect of high versus normal BMI on these complications appeared more pronounced within 7 days after the TAVI procedure. A significant linear association between increased BMI and vascular complications was observed at this time frame (p = 0.03). In conclusion, compared with normal BMI, both obese and overweight patients undergoing TAVI, experience increased rates of 30-day vascular and bleeding complications. These findings indicate that high BMI is an independent risk predictor of vascular and bleeding complications after TAVI.

Incidence, predictors and clinical impact of permanent pacemaker insertion in women following transcatheter aortic valve implantation: Insights from a prospective multinational registry.

OBJECTIVES: To describe the incidence, predictors, and clinical impact of permanent pacemaker insertion (PPI) following transcatheter aortic valve replacement (TAVR) in women. BACKGROUND: Data on pacemaker insertion complicating TAVR in women are scarce. METHODS: The Women's International Transcatheter Aortic Valve implantation (WIN-TAVI) is a prospective registry evaluating the safety and efficacy of TAVR in women. We included patients without preprocedural pacemakers and divided them into two groups: (1) PPI and (2) no-PPI. We identified PPI predictors using logistic regression and studied its clinical impact on the Valve Academic Research Consortium (VARC)-2 efficacy and safety endpoints. RESULTS: Out of 1019 patients, 922 were included in the analysis. Post-TAVR PPI occurred in 132 (14.3%) patients. Clinical and procedural characteristics were similar in both groups. Pre-existing right bundle branch block (RBBB) was associated with a high risk of post-TAVR PPI (OR 3.62, 95% CI 1.85-7.06, p < 0.001), while implantation of balloon-expandable prosthesis was associated with a lower risk (OR 0.47, 95% CI 0.30-0.74, p < 0.001). Post-TAVR PPI prolonged in-hospital stay by a median of 2 days (11 [9-16] days in PPI vs. 9 [7-14] days in no-PPI, p = 0.005), yet risks of VARC-2 efficacy and safety endpoints at 1 year were similar in both groups (adj HR 0.95, 95% CI 0.60-1.52, p = 0.84 and adj HR 1.22, 95% CI 0.83-1.79, p = 0.31, respectively). CONCLUSION: Pacemaker implantation following TAVR is frequent among women and is associated with pre-existing RBBB and valve type. PPI prolongs hospital stay, albeit without any significant impact on 1-year outcomes.

Permanent Pacemaker Implantation Following Valve-in-Valve Transcatheter Aortic Valve Replacement: VIVID Registry.

BACKGROUND: Permanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly with the use of newer-generation transcatheter heart valves (THVs). OBJECTIVES: The goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures. METHODS: Data were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months [interquartile range: 3 to 41 months]) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs. RESULTS: A total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon- and self-expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio [OR]: 1.05 for each increase of 1 year; 95% confidence interval [CI]: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups). CONCLUSIONS: In a contemporary large series of ViV-TAVR patients, the rate of periprocedural PPI was relatively low, and its incidence decreased with the use of new-generation THV systems. PPI following ViV-TAVR was associated with a trend toward increased mortality at follow-up.

Comparing the Safety and Effectiveness of Five Leading New-Generation Devices for Transcatheter Aortic Valve Implantation: Twelve-Month Results From the RISPEVA Study.

OBJECTIVES: The management of severe aortic stenosis has been revolutionized by the introduction of transcatheter aortic valve implantation (TAVI), especially in patients at intermediate, high, or prohibitive surgical risk. There is uncertainty, however, regarding the comparative effectiveness and safety of contemporary TAVI devices. METHODS: We queried detailed data from the ongoing national Italian TAVI registry and compared baseline features, procedural details, and 12-month outcomes of Acurate Neo (Boston Scientific), Evolut Pro/R (Medtronic), Lotus (Boston Scientific), Portico (Abbott Vascular), and Sapien/ Sapien S3 Ultra (Edward Lifesciences) transcatheter aortic valves. Several endpoints were collected and appraised, including the composite of death, stroke, myocardial infarction (MI), major bleeding, major vascular complication, surgical aortic valve replacement and transcatheter aortic valve reimplantation, which were deemed major adverse events (MAEs). RESULTS: A total of 1976 patients were included, with 234 treated with Acurate, 703 with Evolut, 151 with Lotus, 347 with Portico, and 541 with Sapien. Twelve-month events were not significantly different among the 5 devices, including death (P=.29) and MAE (P=.21), with the notable exception of major vascular complications, which were more common with Acurate and Sapien (P<.001) and permanent pacemaker implantation, which was more frequent with Lotus and Evolut (P<.001). Differences in MAE were more pronounced in women and subjects with prior cardiac surgery, with the lowest event rates in the Evolut group. Propensity-score adjusted analysis suggested that Acurate, Evolut, Portico, and Sapien were all associated with similarly favorable results, whereas adverse events were more evident with Lotus (P<.05). CONCLUSION: Leading current-generation TAVI devices offer similarly favorable results at mid-term follow-up.

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.