Functional Mitral Valve Regurgitation: Mitral Valve Repair or Replacement? Our "Road Map" for the Appropriate Strategy.

Objectives: The optimal surgical approach for the treatment of functional mitral regurgitation (FMR) remains controversial. Current guidelines suggest that the surgical approach has to be tailored to the individual patient. The aim of the present study was to clarify further aspects of this tailored treatment. Methods: From 01/2006 to 12/2015, 390 patients underwent mitral valve (MV) surgery for FMR (ischemic n = 241, non-ischemic n = 149) at our institution. A regression analysis was used to determine the effect of MV repair or replacement on survival. The patients were analyzed according to the etiology of the MR (ischemic or non-ischemic), different age groups (<65 years, 65-75 years, and >75 years), LV function, and LV dimensions, as well as the underlying heart rhythm. Results: The overall survival rates for the repair group at 1, 5, and 8 years were 86.1 ± 1.9%, 70.6 ± 2.6%, and 55.1 ± 3.1%, respectively. For the same intervals, the survival rates in patients who underwent MV replacement were 75.9 ± 4.5%, 58.6 ± 5.4%, and 40.9 ± 6.4%, respectively (p = 0.003). Patients younger than 65 years, with an ischemic etiology of FMR, poor ejection fraction (<30%), severe dilatation of left ventricle (LVEDD > 60mm), and presence of atrial fibrillation had significantly higher mortality rates after MV replacement (HR, 3.0; CI, 1.3-6.9; p = 0.007). Patients between 65 and 75 years of age had a higher risk of death when undergoing mitral valve replacement (HR, 1.7; CI, 1.0-2.8; p = 0.04). In patients older than 75 years, the surgical approach (MV repair or replacement) had no effect on postoperative survival (HR, 0.8; CI, 0.4-1.3; p = 0.003). Conclusions: Our data demonstrate that, in patients younger than 65 years, the treatment of choice for FMR should be MV repair. This advantage was even more evident in patients with an ischemic origin of MR, a poor ejection fraction, a severe LV dilatation, and atrial fibrillation.

Impact of Patient-Prosthesis Mismatch on Long-term Outcomes After Aortic Valve Replacement.

BACKGROUND: Patient-prosthesis mismatch (PPM) after aortic valve replacement potentially affects the outcome after the operation. This study sought to determine whether PPM has an impact on long-term mortality and reoperation rates. METHODS: We included 645 patients who underwent biologic aortic valve replacement between 2000 and 2007. Based on echocardiographic examinations at postoperative month 6, the incidence of PPM was determined according to an indexed effective orifice area <0.85 cm2/m2. Survival and reoperation status were analyzed during 15 years of follow-up. RESULTS: PPM was present in 256 patients (40%), of whom 175 had moderate PPM and 81 had severe PPM. In multivariable adjusted analysis, survival was not statistically significantly impaired in patients with moderate PPM compared with patients with no PPM, whereas patients with severe PPM showed a marginally significant impairment of survival (hazard ratio [HR], 1.40; 95% CI, 0.99-1.97; P = .054). Risk factors for survival were higher age (HR, 1.12; 95% CI, 1.10-1.14; P < .001), arterial hypertension (HR, 1.78; 95% CI, 1.38-2.31; P < .001), and diabetes mellitus (HR, 1.67; 95% CI, 1.31-2.14; P < .001). In patients with no, moderate, and severe PPM, there were 10.1, 8.5, and 14.8 events of reoperation/1000 patient-years, respectively. The corresponding 10-year cumulative incidence of reoperation was 8.3%, 6.7%, and 12.1%, respectively. In multivariable adjusted analysis, PPM category was not significantly associated with the risk of reoperation (P > .2). CONCLUSIONS: In our study with directly measured effective orifice area, PPM was only marginally related to long-term survival and was not statistically significantly associated with the risk of reintervention.

Bridge-to-transplant temporary mechanical circulatory support and risk of allosensitization.

INTRODUCTION: Since the 2018 change in the US adult heart allocation policy, more patients are bridged-to-transplant on temporary mechanical circulatory support (tMCS). Previous studies indicate that durable left ventricular assist devices (LVAD) may lead to allosensitization. The goal of this study was to assess whether tMCS implantation is associated with changes in sensitization. METHODS: We included patients evaluated for heart transplants between 2015 and 2022 who had alloantibody measured before and after MCS implantation. Allosensitization was defined as development of new alloantibodies after tMCS implant. RESULTS: A total of 41 patients received tMCS before transplant. Nine (22.0%) patients developed alloantibodies following tMCS implantation: 3 (12.0%) in the intra-aortic balloon pump group (n = 25), 2 (28.6%) in the microaxial percutaneous LVAD group (n = 7), and 4 (44.4%) in the veno-arterial extra-corporeal membrane oxygenation group (n = 9)-p = .039. Sensitized patients were younger (44.7 ± 11.6 years vs. 54.3 ± 12.5 years, p = .044), were more likely to be sensitized at baseline - 3 of 9 (33.3%) compared to 2 out of 32 (6.3%) (p = .028) and received more transfusions with red blood cells (6 (66.6%) vs. 8 (25%), p = .02) and platelets (6 (66.6%) vs. 5 (15.6%), p = .002). There was no significant difference in tMCS median duration of support (4 [3,15] days vs. 8.5 [5,14.5] days, p = .57). Importantly, out of the 11 patients who received a durable LVAD after tMCS, 5 (45.5%) became sensitized, compared to 4 out of 30 patients (13.3%) who only had tMCS-p = .028. CONCLUSIONS: Our findings suggest that patients bridged-to-transplant with tMCS, without significant blood product transfusions and a subsequent durable LVAD implant, have a low risk of allosensitization. Further studies are needed to confirm our findings and determine whether risk of sensitization varies by type of tMCS and duration of support.

Hospital Readmissions in Patients Supported with Durable Centrifugal-Flow Left Ventricular Assist Devices.

Background: Centrifugal-flow left ventricular assist devices (CF-LVADs) have improved morbidity and mortality for their recipients. Hospital readmissions remain common, negatively impacting quality of life and survival. We sought to identify risk factors associated with hospital readmissions among patients with CF-LVADs. Methods: Consecutive patients receiving a CF-LVAD between February 2011 and March 2021 were retrospectively evaluated using prospectively maintained institutional databases. Hospital readmissions within three years post-LVAD implantation were dichotomized into heart failure (HF)/LVAD-related or non-HF/LVAD-related readmissions. Multivariable Cox regression models augmented using a machine learning algorithm, the least absolute shrinkage and selection operator (LASSO) method, for variable selection were used to estimate associations between HF/LVAD-related readmissions and pre-, intra- and post-operative clinical variables. Results: A total of 204 CF-LVAD recipients were included, of which 138 (67.7%) had at least one HF/LVAD-related readmission. HF/LVAD-related readmissions accounted for 74.4% (436/586) of total readmissions. The main reasons for HF/LVAD-related readmissions were major bleeding, major infection, HF exacerbation, and neurological dysfunction. Using pre-LVAD variables, HF/LVAD-related readmissions were associated with substance use, previous cardiac surgery, HF duration, pre-LVAD inotrope dependence, percutaneous LVAD/VA-ECMO support, LVAD type, and the left ventricular ejection fraction in multivariable analysis (Harrell's concordance c-statistic; 0.629). After adding intra- and post-operative variables in the multivariable model, LVAD implant hospitalization length of stay was an additional predictor of readmission. Conclusions: Using machine learning-based techniques, we generated models identifying pre-, intra-, and post-operative variables associated with a higher likelihood of rehospitalizations among patients on CF-LVAD support. These models could provide guidance in identifying patients with increased readmission risk for whom clinical strategies to mitigate this risk may further improve LVAD recipient outcomes.

Artificial intelligence predictive analytics in heart failure: results of the pilot phase of a pragmatic randomized clinical trial.

OBJECTIVES: We conducted an implementation planning process during the pilot phase of a pragmatic trial, which tests an intervention guided by artificial intelligence (AI) analytics sourced from noninvasive monitoring data in heart failure patients (LINK-HF2). MATERIALS AND METHODS: A mixed-method analysis was conducted at 2 pilot sites. Interviews were conducted with 12 of 27 enrolled patients and with 13 participating clinicians. iPARIHS constructs were used for interview construction to identify workflow, communication patterns, and clinician's beliefs. Interviews were transcribed and analyzed using inductive coding protocols to identify key themes. Behavioral response data from the AI-generated notifications were collected. RESULTS: Clinicians responded to notifications within 24 hours in 95% of instances, with 26.7% resulting in clinical action. Four implementation themes emerged: (1) High anticipatory expectations for reliable patient communications, reduced patient burden, and less proactive provider monitoring. (2) The AI notifications required a differential and tailored balance of trust and action advice related to role. (3) Clinic experience with other home-based programs influenced utilization. (4) Responding to notifications involved significant effort, including electronic health record (EHR) review, patient contact, and consultation with other clinicians. DISCUSSION: Clinician's use of AI data is a function of beliefs regarding the trustworthiness and usefulness of the data, the degree of autonomy in professional roles, and the cognitive effort involved. CONCLUSION: The implementation planning analysis guided development of strategies that addressed communication technology, patient education, and EHR integration to reduce clinician and patient burden in the subsequent main randomized phase of the trial. Our results provide important insights into the unique implications of implementing AI analytics into clinical workflow.

Machine Learning Multicenter Risk Model to Predict Right Ventricular Failure After Mechanical Circulatory Support: The STOP-RVF Score.

Importance: The existing models predicting right ventricular failure (RVF) after durable left ventricular assist device (LVAD) support might be limited, partly due to lack of external validation, marginal predictive power, and absence of intraoperative characteristics. Objective: To derive and validate a risk model to predict RVF after LVAD implantation. Design, Setting, and Participants: This was a hybrid prospective-retrospective multicenter cohort study conducted from April 2008 to July 2019 of patients with advanced heart failure (HF) requiring continuous-flow LVAD. The derivation cohort included patients enrolled at 5 institutions. The external validation cohort included patients enrolled at a sixth institution within the same period. Study data were analyzed October 2022 to August 2023. Exposures: Study participants underwent chronic continuous-flow LVAD support. Main Outcome and Measures: The primary outcome was RVF incidence, defined as the need for RV assist device or intravenous inotropes for greater than 14 days. Bootstrap imputation and adaptive least absolute shrinkage and selection operator variable selection techniques were used to derive a predictive model. An RVF risk calculator (STOP-RVF) was then developed and subsequently externally validated, which can provide personalized quantification of the risk for LVAD candidates. Its predictive accuracy was compared with previously published RVF scores. Results: The derivation cohort included 798 patients (mean [SE] age, 56.1 [13.2] years; 668 male [83.7%]). The external validation cohort included 327 patients. RVF developed in 193 of 798 patients (24.2%) in the derivation cohort and 107 of 327 patients (32.7%) in the validation cohort. Preimplant variables associated with postoperative RVF included nonischemic cardiomyopathy, intra-aortic balloon pump, microaxial percutaneous left ventricular assist device/venoarterial extracorporeal membrane oxygenation, LVAD configuration, Interagency Registry for Mechanically Assisted Circulatory Support profiles 1 to 2, right atrial/pulmonary capillary wedge pressure ratio, use of angiotensin-converting enzyme inhibitors, platelet count, and serum sodium, albumin, and creatinine levels. Inclusion of intraoperative characteristics did not improve model performance. The calculator achieved a C statistic of 0.75 (95% CI, 0.71-0.79) in the derivation cohort and 0.73 (95% CI, 0.67-0.80) in the validation cohort. Cumulative survival was higher in patients composing the low-risk group (estimated <20% RVF risk) compared with those in the higher-risk groups. The STOP-RVF risk calculator exhibited a significantly better performance than commonly used risk scores proposed by Kormos et al (C statistic, 0.58; 95% CI, 0.53-0.63) and Drakos et al (C statistic, 0.62; 95% CI, 0.57-0.67). Conclusions and Relevance: Implementing routine clinical data, this multicenter cohort study derived and validated the STOP-RVF calculator as a personalized risk assessment tool for the prediction of RVF and RVF-associated all-cause mortality.

Left ventricular functional improvement appears to contribute to lower rates of device thrombosis in patients on durable mechanical circulatory support.

By unloading the failing heart, left ventricular (LV) assist devices (LVADs) provide a favorable environment for reversing adverse structural and functional cardiac changes. Prior reports have suggested that an improved native LV function might contribute to the development of LVAD thrombosis. We used the Interagency Registry for Mechanically Assisted Circulatory Support and found that LV functional improvement is associated with a lower risk for device thrombosis. The risk for cerebrovascular accident and transient ischemic attack was comparable across post-LVAD LV function subgroups, while the risk of hemolysis was lower in subgroups of patients with better LV function on LVAD support.

Safety of same-day discharge versus overnight stay strategy following cardiac device implantations: a high-volume single-centre experience.

BACKGROUND: The strategy of cardiac implantable electronic device (CIED) implantations performed as day-case admissions has gained a wider acceptance overtime; however, data on safety are still limited. This study aims to investigate the safety of a same-day discharge protocol introduced in our hospital for the postprocedural management of patients undergoing CIED implantation. METHODS: Α prospective, non-interventional, non-randomised study performed in a single high-volume implanting centre for a 16-month period (March 2020 to June 2021). At total of 821 of 965 (85.1%) patients scheduled for elective CIED implantation were considered to be eligible for inclusion in the Short-stay Device Management Protocol. These patients were compared with a historical group of 932 patients, meeting the same inclusion criteria. RESULTS: Procedure was successful in 812 patients (98.9%), committed to same-day discharge versus 921 of 932 patients (98.8%) admitted for overnight stay (p = 0.87). Overall, 90-day complication rate was comparable in both groups (4.14% vs 4.07%, p = 0.95), as was major (1.46% vs. 1.82%, p = 0.55) and minor (2.67% vs. 2.25%, p = 0.64) complication rates. The composite early post-procedural complication rates and late post-procedural complication rates were comparable among groups (0.97 vs 1.18%, p = 0.70 and 0.73% vs 0.64%, p = 0.83, respectively). Six hundred sixty-seven patients (84%) preferred the same-day discharge strategy. Finally, a reduction of 792 bed-days was recorded, resulting in possible financial Health System benefits. CONCLUSIONS: Same-day discharge is feasible and safe in the majority of patients referred for CIED implantation. Additionally, same-day discharge is preferred by patients and may reduce procedure-related costs due to significant bed-day reductions.

COVID-19 in Patients with Melanoma: A Single-Institution Study.

We conducted a single-center, non-interventional retrospective study of melanoma patients with COVID-19 (1 March 2020 until 17 March 2023). The cohort was further divided into three groups according to the periods of SARS-CoV-2 variant dominance in Greece. We recorded demographics, comorbidities, vaccination data, cancer diagnosis/stage, types of systemic melanoma treatments, date of COVID-19 diagnosis and survival. We identified 121 patients. The vast majority (87.6%) had advanced disease (stages III or IV). A total of 80.1% of the patients were receiving immune checkpoint inhibitor-based therapies, 92.5% had asymptomatic/mild COVID-19 and 7.4% had moderate/severe/critical disease, while 83.5% contracted COVID-19 during the third period of the pandemic. Sixteen patients (13.2%) were hospitalized for COVID-19 with a median length of stay of 12 days (range: 1-55 days). Advanced age, heart failure, number of comorbidities (≤1 vs. >1), vaccination status and the time period of the infection correlated with more severe COVID-19, whereas only heart failure and time period were independently correlated with severity. The 30-day mortality rate after COVID-19 was 4.2%. With a median follow-up of 340 days post-COVID-19, 17.4% of patients were deceased. In this cohort of melanoma patients with COVID-19, the 30-day mortality rate was low. There was no association between melanoma stage, treatment receipt and type of treatment with COVID-19 severity.

Blood pressure control measures and cardiovascular outcomes: a prospective hypertensive cohort.

PURPOSE: We investigated whether blood pressure (BP) control measures, visit-to-visit BP variability, and time in therapeutic range (TTR) are associated with future cardiovascular outcomes in hypertensive patients. MATERIALS AND METHODS: Among 1,408 hypertensive patients without cardiovascular disease, we prospectively evaluated the incident major cardiovascular events over 6 years. In newly diagnosed patients, antihypertensive drug treatment was initiated. We estimated two markers of on-treatment BP control, (1) visit-to-visit BPV as the coefficient of variation of office systolic BP (BP-CV), and (2) TTR calculated as the percentage of office systolic BP measurements within 120-140mmHg across visits. RESULTS: The hypertensive cohort (672 males, mean age 60 years, 31% newly diagnosed) had a mean systolic/diastolic BP of 142/87 mmHg. The mean number of visits was 4.9 ± 2.6, while the mean attained systolic/diastolic BP during follow-up was 137/79 mmHg using 2.7 ± 1.1 antihypertensive drugs. The BP-CV and TTR were 9.1 ± 4.1% and 45 ± 29%, respectively, and the incidence of the composite outcome was 8.3% (n = 117). After adjustment for relevant confounders and standardization to z-scores, BP-CV and TTR were associated with a 43% (95% CI, 27-62%) increase and a 33% (95% CI, 15-47%) reduction in the outcome. However, the joint evaluation of TTR and BP-CV in a common multivariable model indicated that a standardized change of TTR was associated with the outcome to a greater extent than BP-CV (mean hazard ratios of 30% vs. 24%, respectively). When combined with the higher BP standardized-CV quartile, the lower TTR quartile predicted the outcome by 2.3 times (95% CI, 1.1-5.4) compared to the inverse TTR and BP-CV quartile pattern. CONCLUSION: High BP-CV or low TTR was associated with future cardiovascular events in a cohort of treated hypertensive patients. As a determinant, the extent of TTR value appears greater than BP-CV when these measures are considered in the same multivariable model.

AVNeo improves early haemodynamics in regurgitant bicuspid aortic valves compared to aortic valve repair.

OBJECTIVES: Calcified or fibrotic cusps in patients with bicuspid aortic valves and aortic regurgitation complicate successful aortic valve (AV)-repair. Aortic valve neocuspidization (AVNeo) with autologous pericardium offers an alternative treatment to prosthetic valve replacement. We compared patients with regurgitant bicuspid valves undergoing AV-repair or AVNeo. METHODS: We retrospectively analysed patients with regurgitant bicuspid valves undergoing AV-repair or AVNeo. We focused on residual regurgitation, pressure gradients and effective orifice area, determined preoperatively and at discharge. RESULTS: AV-repair was performed in 61 patients (mean age: 43.2 ± 11.3 years) and AVNeo in 22 (45.7 ± 14.1). Prior to the operation patients of the AV-repair group showed severe regurgitation in 38 cases (62.3%) and moderate in 23 (37.6%); in the AVNeo group, all patients exhibited severe regurgitation. Postoperatively, 57 patients (93.4%) patients had no or mild regurgitation after AV-repair and 21 (95.4%) after AVNeo. In AVNeo-patients, peak (10.6 ± 3.1 mmHg vs 22.7 ± 11 mmHg, P< 0.001) and mean pressure gradients (5.9 ± 2 mmHg vs 13.8 ± 7.3 mmHg, P < 0.001) were significantly lower and the orifice area significantly larger (2.9 ± 0.8 cm2 vs 1.9 ± 0.7 cm2, P < 0.001) compared to repair. CONCLUSIONS: Compared to AV-repair, patients AVNeo showed lower mean pressure gradients and larger orifice areas at discharge. The functional result was not different.

LVAD as a Bridge to Remission from Advanced Heart Failure: Current Data and Opportunities for Improvement.

Left ventricular assist devices (LVADs) are an established treatment modality for advanced heart failure (HF). It has been shown that through volume and pressure unloading they can lead to significant functional and structural cardiac improvement, allowing LVAD support withdrawal in a subset of patients. In the first part of this review, we discuss the historical background, current evidence on the incidence and assessment of LVAD-mediated cardiac recovery, and out-comes including quality of life after LVAD support withdrawal. In the second part, we discuss current and future opportunities to promote LVAD-mediated reverse remodeling and improve our pathophysiological understanding of HF and recovery for the benefit of the greater HF population.

Non-robotic minimally invasive mitral valve repair: a 20-year single-centre experience.

OBJECTIVES: Minimally invasive mitral valve repair (MVR) promises major advantages over median sternotomy regarding cosmetic results and faster recovery. However, the long-term functional outcome of minimally invasive MVR has been questioned by critics because the limited access may not exclusively promise high-quality repair. This study examines the long-term outcome regarding survival and reoperation rate. METHODS: All patients undergoing minimally invasive MVR from February 2000 until March 2020 were included in this study. Baseline clinical and surgical characteristics were summarized from the internal database. Primary end points were survival and freedom from reoperation, analysed via Kaplan-Meier curves. Secondary end points were periprocedural complications after minimally invasive MVR and incidence for recurrent mitral regurgitation >II°. RESULTS: A total of 1194 patients underwent minimally invasive MVR, in 17 cases mitral valve replacement was required. The mean age was 55.1 years [47.6; 62.7]. The successful minimally invasive repair rate was 97%. The 30-day mortality was 0.6%. Survival was 96.7% [standard deviation (SD): 5.8%], 91.6% (SD: 1.1%) and 80.0% (SD: 11.2%) at 5, 10 and 20 years. The incidence of reoperation was 4.4% (SD: 3.2%), 10.3% (SD: 7.4%) and 16.7% (SD : 7.4%) at 5, 10 and 20 years, respectively. Concomitant procedures such as tricuspid valve repair and modified Cryo-maze procedure were performed in 263 cases. CONCLUSIONS: Minimally invasive MVR for degenerative mitral regurgitation is safe, shows excellent functional long-term results and is associated with low perioperative and late mortality.

Repair of Mitral Valves with Severe Annular Dilatation and Abundant Leaflet Tissue Using a Prosthetic Ring with a Large Anterior-Posterior Diameter.

BACKROUND: Mitral valve (MV) repair in the case of a large anterior-posterior diameter and redundant valve tissue remains challenging and favors repair with a ring that exhibits a large anterior-posterior diameter. Compared to other available rings, the Medtronic Simulus annuloplasty ring shows the largest anterior-posterior diameter. This study reports for the first time mid-term results using this annuloplasty ring. METHODS: Between 11/2015 and 12/2019, a total of 378 patients underwent MV repair for degenerative mitral regurgitation using the Medtronic Simulus ring, according to the following selection criteria: large MV annuli, abundant leaflet tissue (i.e., Barlow disease), and risk for SAM. RESULTS: Overall survival after 5 years was 90.8 ± 4.6%. Five patients required valve-related reoperations because of ring dehiscence (n = 1), progression of native valve disease (n = 2), dehiscence of quadrangular resection suture (n = 1), and endocarditis (n = 1). The cumulative incidence of valve-related reoperation at 5 years was 1.3 ± 0.5%. At latest follow-up, echocardiography demonstrated excellent valve function with no/mild MR in 299 patients (94.6%). Two patients (0.6%) had more than moderate MR. No patient developed SAM after repair. CONCLUSION: Repair of MV with large annuli and abundant leaflet tissue with the Medtronic Simulus annuloplasty ring shows excellent mid-term results regarding reoperation rates and recurrent MR.

His bundle pacing: A promising alternative strategy for anti-bradycardic pacing - report of a single-center experience.

His bundle pacing (HBP) is proven to be a safe and effective alternative pacing modality that, in addition, avoids pacemaker-induced cardiomyopathy (PICM) by achieving a "physiological" ventricular stimulation, via the native conduction system. Indications include various causes of bradycardia requiring anti-bradycardic pacing, inadequately controlled atrial fibrillation requiring AV node ablation and established PICM. In addition, HBP may also be used as an alternative therapy for patients with heart failure (HF) and an indication for cardiac resynchronization therapy (CRT). Available data show several advantages of HBP with regard to preservation or restoration of intra- and inter-ventricular synchronization; improvement in left ventricular ejection fraction, functional status and quality of life; decrease in atrial fibrillation incidence and improvement in HF hospitalization rates, compared with conventional pacing. Nevertheless, superiority in terms of mortality rates has not been consistently demonstrated, and the long-term efficacy and safety of HBP remain to be proven. In the present manuscript, we review the status of HBP and present our current experience with this novel pacing modality.

Anatomical reasons for failure of dual-filter cerebral embolic protection application in TAVR: A CT-based analysis.

BACKGROUND: The dual-filter Sentinel™ Cerebral Protection System (Sentinel-CPS) is increasingly used during transcatheter aortic valve replacement (TAVR). However, complex vascular anatomy may challenge Sentinel-CPS deployment. AIM OF THE STUDY: We sought to investigate the impact of anatomic features of the aortic arch and the supra-aortic arteries on technical device failure of Sentinel-CPS application. METHODS: Analysis of the multislice computed tomography pre-TAVR aortograms of all patients undergoing TAVR with Sentinel-CPS between 2016 and 2020 (n = 92) was performed. We investigated the impact of aortic arch anatomy, configuration, and the angles of the supra-aortic arteries, including the determination of vascular tortuosity index on device failure of Sentinel-CPS application. RESULTS: The Sentinel-CPS was applied successfully in 83 patients (90.2%). Device failure in nine patients (9.8%) was due to the infeasibility to perform correct deployment of both filters (n = 7) and to obtain peripheral radial access (n = 2). Patients with a failure of Sentinel-CPS application had a higher right subclavian tortuosity index (217 [92-324] vs. 150 [42-252], p = .046), a higher brachiocephalic tortuosity index (27 [5-51] vs. 10 [0-102], p = 0.033) and a larger angulation of the brachiocephalic artery (59° [22-80] vs. 39° [7-104], p = .014) compared with patients with successful application. A brachiocephalic angle more than 59° was predictive for device failure. No differences in aortic arch anatomy or common carotid artery tortuosity were detected between the groups. CONCLUSIONS: Brachiocephalic tortuosity was found to be associated with failure of Sentinel-CPS application. Filter-based usage should be avoided in TAVR patients with a brachiocephalic angle more than 59°.