Osteosarcopenia and Mortality in Older Adults Undergoing Transcatheter Aortic Valve Replacement.

Importance: Osteosarcopenia is an emerging geriatric syndrome characterized by age-related deterioration in muscle and bone. Despite the established relevance of frailty and sarcopenia among older adults undergoing transcatheter aortic valve replacement (TAVR), osteosarcopenia has yet to be investigated in this setting. Objective: To determine the association between osteosarcopenia and adverse outcomes following TAVR. Design, Setting, and Participants: This is a post hoc analysis of the Frailty in Aortic Valve Replacement (FRAILTY-AVR) prospective multicenter cohort study and McGill extension that enrolled patients aged 70 years or older undergoing TAVR from 2012 through 2022. FRAILTY-AVR was conducted at 14 centers in Canada, the United States, and France between 2012 and 2016, and patients at the McGill University-affiliated center in Montreal, Québec, Canada, were enrolled on an ongoing basis up to 2022. Exposure: Osteosarcopenia as measured on computed tomography (CT) scans prior to TAVR. Main Outcomes and Measures: Clinically indicated CT scans acquired prior to TAVR were analyzed to quantify psoas muscle area (PMA) and vertebral bone density (VBD). Osteosarcopenia was defined as a combination of low PMA and low VBD according to published cutoffs. The primary outcome was 1-year all-cause mortality. Secondary outcomes were 30-day mortality, hospital length of stay, disposition, and worsening disability. Multivariable logistic regression was used to adjust for potential confounders. Results: Of the 605 patients (271 [45%] female) in this study, 437 (72%) were octogenarian; the mean (SD) age was 82.6 (6.2) years. Mean (SD) PMA was 22.1 (4.5) cm2 in men and 15.4 (3.5) cm2 in women. Mean (SD) VBD was 104.8 (35.5) Hounsfield units (HU) in men and 98.8 (34.1) HU in women. Ninety-one patients (15%) met the criteria for osteosarcopenia and had higher rates of frailty, fractures, and malnutrition at baseline. One-year mortality was highest in patients with osteosarcopenia (29 patients [32%]) followed by those with low PMA alone (18 patients [14%]), low VBD alone (16 patients [11%]), and normal bone and muscle status (21 patients [9%]) (P < .001). Osteosarcopenia, but not low VBD or PMA alone, was independently associated with 1-year mortality (odds ratio [OR], 3.18; 95% CI, 1.54-6.57) and 1-year worsening disability (OR, 2.11; 95% CI, 1.19-3.74). The association persisted in sensitivity analyses adjusting for the Essential Frailty Toolset, Clinical Frailty Scale, and geriatric conditions such as malnutrition and disability. Conclusions and Relevance: The findings suggest that osteosarcopenia detected using clinical CT scans could be used to identify frail patients with a 3-fold increase in 1-year mortality following TAVR. This opportunistic method for osteosarcopenia assessment could be used to improve risk prediction, support decision-making, and trigger rehabilitation interventions in older adults.

Protein and Exercise to Reverse Frailty in Older Men and Women Undergoing Transcatheter Aortic Valve Replacement: Design of the PERFORM-TAVR Trial.

Despite the high procedural success of transcatheter aortic valve replacement (TAVR), 2 out of 5 older adults report poor physical performance and health-related quality of life (HRQOL) in the ensuing months, particularly those with frailty. There has yet to be a trial examining the synergistic effects of exercise and protein supplementation to counteract frailty and improve patient-centred outcomes following TAVR. The PERFORM-TAVR trial is a multicentre parallel-group randomised clinical trial that is enrolling 200 frail older adults ≥ 70 years of age undergoing TAVR. Patients will be randomly allocated to 1 of 2 treatment groups: standard-of-care lifestyle education (control group) or protein-rich oral nutritional supplement for 4 weeks before TAVR with the addition of home-based supervised exercise sessions for 12 weeks after TAVR (intervention group). The primary outcome will be physical performance as measured by a blinded observer using the Short Physical Performance Battery at 3 months. Secondary outcomes at 3, 6, and 12 months will include HRQOL, as measured by the Short-Form 36 Physical and Mental Component summary scores, and a composite safety end point. The PERFORM-TAVR trial is testing a novel frailty intervention in older adults undergoing TAVR to optimise recovery and downstream HRQOL. This represents a potential paradigm shift that highlights the value of assessing and treating patients' frailty in parallel with their underlying heart valve disease. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03522454.

The Role of CT-Guided Optimal Fluoroscopic Viewing Angle to Guide Right Endomyocardial Biopsy.

We report the case of a 64-year-old man with a history of chemotherapy-induced cardiomyopathy requiring heart transplant in 2022 who underwent successful endomyocardial biopsy using patient-specific computed tomographic fluoroscopic projections. (Level of Difficulty: Beginner.).

The Role of CT-Guided Optimal Fluoroscopic Viewing Angle for Coronary Engagement After TAVR.

We report the case of an 89-year-old woman with prior transcatheter aortic valve replacement who underwent successful left coronary artery engagement and left circumflex percutaneous coronary intervention using patient-specific computed tomography fluoroscopic projections. (Level of Difficulty: Advanced.).

Outcomes in Patients Undergoing Surgical Aortic Valve Replacement With vs Without a Preoperative Heart Team Assessment.

Background: This study sought to compare characteristics and outcomes of patients who underwent surgical aortic valve replacement (SAVR) after being referred to a heart team (HT), to those of patients referred directly for SAVR. Methods: An analysis of patients who underwent SAVR from 2015 to 2020 was conducted. Patients were categorized into 3 groups, as follows: (i) H-HT: patients referred to the HT from 2015 to 2017 (historical cohort); (ii) C-HT: patients referred to the HT from 2018 to 2020 (contemporary cohort); and (iii) No-HT: patients referred directly to cardiac surgery from 2018 to 2020. Two subanalyses were performed: H-HT vs C-HT patients, and C-HT vs No-HT patients. The primary outcome was a composite of in-hospital mortality, prolonged intubation, reoperation, sternal wound infection, and stroke. Results: This study consisted of 288 patients, distributed as follows: H-HT (n = 45); C-HT (n = 51); and No-HT (n = 192). The mean ages of H-HT, C-HT, and No-HT patients was 76.3 ± 6.9 years, 73.3 ± 7.6 years, and 69.6 ± 9.7 years, respectively (P = 0.0001). H-HT, C-HT, and No-HT patients had average Society of Thoracic Surgeons scores of 4.8 ± 2.2, 3.2 ± 1.6, and 4.2 ± 2 (P = 0.002), respectively. The composite outcome rate was more than 5 times higher among H-HT patients compared to that among the C-HT patients (20.0 vs 3.9%, P = 0.02), and was numerically higher in No-HT compared to C-HT patients (13.0 vs 3.9%, P = 0.07). Conclusions: Referral to an HT appears to be primarily driven by higher chronological age rather than overall risk profile. Patients assessed by the HT prior to undergoing SAVR have a low incidence of complications, comparable to that among patients referred directly to cardiac surgery.

Contexte: Cette étude visait à comparer les caractéristiques et le devenir de patients ayant subi une chirurgie de remplacement valvulaire aortique après avoir été orientés vers une équipe de cardiologie (EC) à ceux de patients orientés directement en chirurgie cardiaque pour une chirurgie de remplacement valvulaire aortique. Méthodologie: Une analyse portant sur les patients ayant subi une chirurgie de remplacement valvulaire aortique de 2015 à 2020 a été effectuée. Les patients ont été divisés en trois groupes, à savoir : i) CH-POEC : patients orientés vers une EC de 2015 à 2017 (cohorte historique); ii) CC-POEC : patients orientés vers une EC de 2018 à 2020 (cohorte contemporaine); iii) PODC : patients orientés directement en chirurgie cardiaque de 2018 à 2020. Deux sous-analyses ont été effectuées : CH-POEC vs CC-POEC, et CC-POEC vs PODC. Le paramètre d'évaluation principal était composite. Il comprenait la mortalité hospitalière, l'intubation prolongée, la réopération, l'infection de la plaie sternale et l'accident vasculaire cérébral. Résultats: L'étude regroupait 288 patients, répartis comme suit : CH-POEC, n = 45; CC-POEC, n = 51; PODC, n = 192. L'âge moyen dans les groupes CH-POEC, CC-POEC et PODC était respectivement de 76,3 ± 6,9 ans, 73,3 ± 7,6 ans et 69,6 ± 9,7 ans (P = 0,0001). Les groupes CH-POEC, CC-POEC et PODC présentaient des indices STS (Society of Thoracic Surgeons) moyens de 4,8 ± 2,2, 3,2 ± 1,6 et 4,2 ± 2 (P = 0,002), respectivement. Le taux composite d'événements au sein du groupe CH-POEC était plus de cinq fois supérieur à celui noté dans le groupe CC-POEC (20,0 vs 3,9 %, P = 0,02). Il était aussi plus élevé au sein du groupe PODC comparativement au groupe CC-POEC (13,0 vs 3,9 %, P = 0,07). Conclusions: Le principal motif d'orientation vers une EC semble être un âge chronologique avancé plutôt que le profil de risque global. Chez les patients qui sont évalués par une EC avant de subir une chirurgie de remplacement valvulaire aortique, l'incidence de complications est faible et comparable à celle observée chez les patients orientés directement en chirurgie cardiaque.

Aortic Annulus S-Curve: Implications for Transcatheter Aortic Valve Replacement and Related Procedures, Part 1.

Most transcatheter aortic valve replacement-related procedures (eg, transcatheter aortic valve replacement implantation depth, commissural alignment, coronary access, bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction, paravalvular leak closure) require an optimal fluoroscopic viewing angle located somewhere along the aortic annulus S-curve. Chamber views, coronary cusp and coronary anatomy, can be understood along the aortic annulus S-curve. A better understanding of the optimal fluoroscopic viewing angles along the S-curve may translate into increased operator confidence and improved safety and efficacy while reducing procedural time, radiation dose, contrast volume, and complication rates.

Canadian Spontaneous Coronary Artery Dissection Cohort Study: 3-Year Outcomes.

BACKGROUND: Spontaneous coronary artery dissection (SCAD) is an important cause of myocardial infarction (MI) in young to middle-aged women. OBJECTIVES: We aim to define the long-term natural history of SCAD. METHODS: We performed a multicenter, prospective, observational study of patients with nonatherosclerotic SCAD presenting acutely from 22 North American centers. We recorded baseline demographics, in-hospital characteristics, precipitating and predisposing conditions, angiographic features (adjudicated), in-hospital and 3-year major adverse cardiovascular events (MACE). Cox regression multivariable analysis was performed. RESULTS: We prospectively enrolled 750 consecutive patients with SCAD from June 2014 to June 2018. Mean age was 51.7 ± 10.5 years, 88.5% were women (55.0% postmenopausal); 31.3% presented with ST-segment elevation myocardial infarction, and 68.3% with non-ST-segment elevation myocardial infarction. Precipitating emotional stressor was reported in 50.3%, and physical stressor in 28.9%. Predisposing conditions included fibromuscular dysplasia in 42.9% (56.4% in those with complete screening), peripartum state 4.5%, and genetic disorders 1.6%. Most patients were treated conservatively (84.3%); 14.1% underwent percutaneous coronary intervention (PCI), 0.7% coronary artery bypass graft. At 3.0-year median follow-up, mortality was 0.8%, recurrent MI 9.9% (extension of previous SCAD 3.5%, de novo recurrent SCAD 2.4%, iatrogenic dissection 1.9%), with overall MACE 14.0%. Presence of genetic disorders, peripartum SCAD, and extracoronary fibromuscular dysplasia were independent predictors of 3-year MACE. Patients who underwent PCI at index hospitalization had similar postdischarge MACE compared with no PCI. At 3 years, 80.0% remained on aspirin and 73.5% on beta-blockade. CONCLUSIONS: Long-term mortality and de novo recurrent SCAD was low in our contemporary large SCAD cohort that included low revascularization rate and high use of beta-blockade and aspirin. Genetic disorders, extracoronary fibromuscular dysplasia, and peripartum SCAD were independent predictors of long-term MACE.

Canadian Cardiovascular Society 2022 Guidelines for Cardiovascular Interventions in Adults With Congenital Heart Disease.

Interventions in adults with congenital heart disease (ACHD) focus on surgical and percutaneous interventions in light of rapidly evolving ACHD clinical practice. To bring rigour to our process and amplify the cumulative nature of evidence ACHD care we used the ADAPTE process; we systematically adjudicated, updated, and adapted existing guidelines by Canadian, American, and European cardiac societies from 2010 to 2020. We applied this to interventions related to right and left ventricular outflow obstruction, tetralogy of Fallot, coarctation, aortopathy associated with bicuspid aortic valve, atrioventricular canal defects, Ebstein anomaly, complete and congenitally corrected transposition, and patients with the Fontan operation. In addition to tables indexed to evidence, clinical flow diagrams are included for each lesion to facilitate a practical approach to clinical decision-making. Excluded are recommendations for pacemakers, defibrillators, and arrhythmia-directed interventions covered in separate designated documents. Similarly, where overlap occurs with other guidelines for valvular interventions, reference is made to parallel publications. There is a paucity of high-level quality of evidence in the form of randomized clinical trials to support guidelines in ACHD. We accounted for this in the wording of the strength of recommendations put forth by our national and international experts. As data grow on long-term follow-up, we expect that the evidence driving clinical practice will become increasingly granular. These recommendations are meant to be used to guide dialogue between clinicians, interventional cardiologists, surgeons, and patients making complex decisions relative to ACHD interventions.

Snare or Scalpel: Challenges of Intracardiac Cement Embolism Retrieval.

Intracardiac cement embolism after percutaneous vertebroplasty is a rare, but dangerous, complication, and guiding principles for its management are not well described. The management of this present case of intracardiac cement embolism offers insight to facilitate the treatment decision-making process in symptomatic patients requiring extraction.

The Essential Frailty Toolset in Older Adults Undergoing Coronary Artery Bypass Surgery.

Background The Essential Frailty Toolset (EFT) was shown to be easy to use and predictive of adverse events in patients undergoing aortic valve replacement procedures. The objective of this study was to evaluate the EFT in patients undergoing coronary artery bypass grafting procedures. Methods and Results The McGill Frailty Registry prospectively included patients ≥60 years of age undergoing urgent or elective isolated coronary artery bypass grafting between 2011 and 2018 at 2 hospitals. The preoperative EFT was scored 0 to 5 points as a function of timed chair rises, Mini-Mental Status Examination, serum albumin, and hemoglobin. The primary outcome was all-cause mortality assessed by Cox proportional hazards regression. The cohort consisted of 500 patients with a mean age of 71.4 ± 6.4 years, of which 27% presented with acute coronary syndromes requiring urgent surgery. The mean EFT was 1.3 ± 1.1 points, 132 (26%) were nonfrail, 298 (60%) were prefrail, and 70 (14%) were frail. Over a median follow-up of 4.0 years, 78 deaths were observed. In nonfrail, prefrail, and frail patients, survival at 1 year was 98%, 95%, and 91%, and at 5 years was 89%, 83%, and 63% (P<0.001). After adjustment, each incremental EFT point was associated with a hazard ratio of 1.28 (95% CI, 1.05-1.56) and frail patients had a 3-fold increase in all-cause mortality. Conclusions The EFT is a pragmatic and highly prognostic tool to assess frailty and guide decisions for coronary artery bypass grafting in older adults. Furthermore, the EFT may be actionable through targeted interventions such as cardiac rehabilitation and nutritional optimization.

Percutaneous Closure of a Giant Aortic Pseudoaneurysm Using Multimodality Imaging Guidance.

Ascending aortic pseudoaneurysm is a rare, life-threatening complication of cardiac surgery. Surgical management is recommended, however, transcatheter techniques offer a less invasive alternative. We describe successful percutaneous closure, guided by using multimodality imaging, in a patient with high surgical risk.

Pegylated interferon beta-1a (Plegridy) Italian real-world experience: a Delphi analysis of injection-site reaction and flu-like symptom management.

BACKGROUND AND AIM: Peginterferon beta-1a (Plegridy) offers the advantage of a prolonged half-life with less-frequent administration and a higher patient adherence. However, the use of an interferon may lead to flu-like symptoms (FLS) and injection-site reactions (ISR) that results in drug discontinuation. The objective of this Delphi analysis was to obtain consensus on the characteristics and management of FLS/ISR of peginterferon beta-1a in patients with relapsing-remitting MS based on real-world clinical experiences.4 METHODS: A steering committee of MS neurologists and nurses identified issues regarding the features and management of adverse events and generated a questionnaire used to conduct three rounds of the Delphi web survey with an Italian expert panel (54 neurologists and nurses). RESULTS: Fifty-three (100%), fifty-one (96.22%), and forty-two (79.24%) responders completed questionnaires 1, 2, and 3 respectively. Responders reported that, during the first 6 months of treatment, FLS generally occurred 6-12 h after injection; the fever tended to resolve after 12-24 h; otherwise, FLS lasted up to 48 h. FLS improved or disappeared after 6 months of treatment in most cases. Paracetamol was recommended as the first choice for managing FLS. Erythema was the most common ISR and usually resolved within 1 week after injection. Responders reported that the adherence to treatment increases after adequate patient education on the drug's tolerability profile. CONCLUSIONS: Patient education and counseling play a key role in promoting adherence to treatment especially in the first months also in patients switching from nonpegylated IFNs to peginterferon beta-1a.

Double S-Curve Versus Cusp-Overlap Technique: Defining the Optimal Fluoroscopic Projection for TAVR With a Self-Expanding Device.

OBJECTIVES: The purpose of this study was to assess the concordance between transcatheter aortic valve implantation angles generated by the "double S-curve" and "cusp-overlap" techniques. BACKGROUND: The "double S-curve" and "cusp-overlap" methods aim to define optimal fluoroscopic projections for transcatheter aortic valve replacement (TAVR) with a self-expandable device. METHODS: The study included 100 consecutive patients undergoing TAVR with self-expanding device planned by multidetector computed tomography. TAVR was performed using the double S-curve model, as a view in which both the aortic valve annulus and delivery catheter planes are displayed perpendicularly on fluoroscopy. Optimal projection according to the cusp-overlap technique was retrospectively generated by overlapping the right and left cups on the multidetector computed tomography annular plane. The angular difference between methods was assessed in spherical 3 dimensions and on the left and right anterior oblique (RAO) and cranial and caudal (CAU) axes. RESULTS: The double S-curve and cusp-overlap methods provided views located in the same quadrant, mostly the RAO and CAU, in 92% of patients with a median 3-dimensional angular difference of 10.0° (interquartile range: 5.5° to 17.9°). The 3-dimensional deviation between the average angulation obtained by each method was not statistically significant (1.49°; p = 0.349). No significant differences in average coordinates were noted between the double S-curve and cusp-overlap methods (RAO: 14.7 ± 15.2 vs. 12.9 ± 12.5; p = 0.36; and CAU: 27.0 ± 9.4 vs. 26.9 ± 10.4; p = 0.90). TAVR using the double S-curve was associated with 98% device success, low complication rate, and absence of moderate-to-severe paravalvular leak. CONCLUSIONS: The double S-curve and cusp-overlap methods provide comparable TAVR projections, mostly RAO and CAU. TAVR using the double S-curve model is associated with a high rate of device success and low rate of procedural complications.

Optimal Fluoroscopic Projections of Coronary Ostia and Bifurcations Defined by Computed Tomographic Coronary Angiography.

OBJECTIVES: The aim of this study was to define the optimal fluoroscopic viewing angles of both coronary ostia and important coronary bifurcations by using 3-dimensional multislice computed tomographic data. BACKGROUND: Optimal fluoroscopic projections are crucial for coronary imaging and interventions. Historically, coronary fluoroscopic viewing angles were derived empirically from experienced operators. METHODS: In this analysis, 100 consecutive patients who underwent computed tomographic coronary angiography (CTCA) for suspected coronary artery disease were studied. A CTCA-based method is described to define optimal viewing angles of both coronary ostia and important coronary bifurcations to guide percutaneous coronary interventions. RESULTS: The average optimal viewing angle for ostial left main stenting was left anterior oblique (LAO) 37°, cranial (CRA) 22° (95% confidence interval [CI]: LAO 33° to 40°, CRA 19° to 25°) and for ostial right coronary stenting was LAO 79°, CRA 41° (95% CI: LAO 74° to 84°, CRA 37° to 45°). Estimated mean optimal viewing angles for bifurcation stenting were as follows: left main: LAO 0°, caudal (CAU) 49° (95% CI: right anterior oblique [RAO] 8° to LAO 8°, CAU 43° to 54°); left anterior descending with first diagonal branch: LAO 11°, CRA 71° (95% CI: RAO 6° to LAO 27°, CRA 66° to 77°); left circumflex bifurcation with first marginal branch: LAO 24°, CAU 33° (95% CI: LAO 15° to 33°, CAU 25° to 41°); and posterior descending artery and posterolateral branch: LAO 44°, CRA 34° (95% CI: LAO 35° to 52°, CRA 27° to 41°). CONCLUSIONS: CTCA can suggest optimal fluoroscopic viewing angles of coronary artery ostia and bifurcations. As the frequency of use of diagnostic CTCA increases in the future, it has the potential to provide additional information for planning and guiding percutaneous coronary intervention procedures.

Predictors of Outcomes Following Transcatheter Edge-to-Edge Mitral Valve Repair.

Transcatheter edge-to-edge mitral valve repair is a viable alternative to surgery in patients with severe mitral regurgitation and high surgical risk. Yet the specific group of patients who would optimally benefit from this therapy remains to be determined. Selection of patients for transcatheter strategy is currently based on surgical prognostic scores and technical feasibility. Meanwhile, various clinical, anatomic, and procedural factors have been recently recognized as predictors of adverse outcomes following transcatheter edge-to-edge mitral valve repair, including device failure, recurrent mitral regurgitation, and mortality. Integration of these prognostic factors in the decision-making process of the heart team might improve patient management and outcomes. Herein, the authors review the different factors related to symptomatic status, comorbidity, serum biomarkers, echocardiographic findings, and procedural technique that have been identified as independent predictors of adverse outcome following transcatheter edge-to-edge mitral valve repair and discuss their potential application in everyday clinical practice.

A Case of TAVR Complicated by Severe Functional Mitral Regurgitation.

Mitral regurgitation (MR) is a known complication of transcatheter aortic valve replacement (TAVR). We report a case of a 90-year-old man with severe symptomatic aortic stenosis who underwent elective TAVR. The procedure was complicated by severe functional MR from left ventricular stunning and dilatation caused by hypotension throughout the procedure. An Impella CP (Abiomed, Inc, Danvers, MA) was inserted to unload the left ventricle and decrease its size with subsequent improvement in MR severity, which was sustained after Impella CP removal. In conclusion, we present the first case of successful management of post-TAVR severe functional MR with an Impella CP.

Restricted mean survival time of older adults with severe aortic stenosis referred for transcatheter aortic valve replacement.

BACKGROUND: Few studies have measured frailty as a potential reason for foregoing transcatheter aortic valve replacement (TAVR) in older adults with severe aortic stenosis (AS). This study sought to determine the impact of frailty and other clinician-cited reasons on restricted mean survival time (RMST). METHODS: An analysis of the McGill Frailty Registry was conducted between 2014 and 2018 at the McGill University Health Center Structural Valve Clinic. Consecutive nonsurgical patients referred for TAVR were included. In those that underwent balloon aortic valvuloplasty or medical management, the primary clinician-cited reason for foregoing TAVR was codified. Vital status was ascertained at 1 year and analysed using RMST and Kaplan-Meier analyses. RESULTS: The study consisted of 373 patients with a mean age of 82.4 years, of which 233 underwent TAVR and 140 did not. Patients who did not undergo TAVR were more likely to be nonagenarians, with left ventricular dysfunction, chronic kidney disease, dementia, disability, depression, malnutrition, and frailty. The primary clinician-cited reason was: comorbidity in 34%, frailty in 23%, procedural feasibility and risks in 16%, and mild or unrelated symptoms in 27%. Compared to the TAVR group, 1-year RMST was reduced by 2.0 months in the medical management group (95% CI 1.2, 2.7) and by 1.1 months in the valvuloplasty group (95% CI -0.2, 2.5). CONCLUSIONS: Patients with severe AS referred for TAVR may never undergo the procedure on the basis of comorbidity, frailty, procedural issues, and symptoms. The best treatment decision is one that follows from multi-disciplinary assessment encompassing frailty.

Frailty and Bleeding in Older Adults Undergoing TAVR or SAVR: Insights From the FRAILTY-AVR Study.

OBJECTIVES: The aim of this study was to examine the value of frailty to predict in-hospital major bleeding and determine its impact on mid-term mortality following transcatheter (TAVR) or surgical (SAVR) aortic valve replacement. BACKGROUND: Bleeding complications are harbingers of mortality and major morbidity in patients undergoing TAVR or SAVR. Despite the high prevalence of frailty in this population, little is known about its effects on bleeding risk. METHODS: A post hoc analysis was performed of the multinational FRAILTY-AVR (Frailty Aortic Valve Replacement) cohort study, which prospectively enrolled older adults ≥70 years of age undergoing TAVR or SAVR. Trained researchers assessed frailty using a questionnaire and physical performance battery pre-procedure and ascertained clinical data from the electronic health record. The primary endpoint was major or life-threatening bleeding during the index hospitalization, and the secondary endpoint was units of packed red blood cells transfused. RESULTS: The cohort consisted of 1,195 patients with a mean age of 81.3 ± 6.0 years. The incidence of life-threatening bleeding, major bleeding with a clinically apparent source, and major bleeding without a clinically apparent source was, respectively, 3%, 6%, and 9% in the TAVR group and 8%, 10%, and 31% in the SAVR group. Frailty measured using the Essential Frailty Toolset was an independent predictor of major bleeding and packed red blood cell transfusions in both groups. Major bleeding was associated with a 3-fold increase in 1-year mortality following TAVR (odds ratio: 3.40; 95% confidence interval: 2.22 to 5.21) and SAVR (odds ratio: 2.79; 95% confidence interval: 1.25 to 6.21). CONCLUSIONS: Frailty is associated with post-procedural major bleeding in older adults undergoing TAVR and SAVR, which is in turn associated with a higher risk for mid-term mortality.