Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus.

BACKGROUND: Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR). METHODS: We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm2 or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority). RESULTS: A total of 716 patients were treated at 83 sites in 13 countries (mean age, 80 years; 87% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality, 3.3%). The Kaplan-Meier estimate of the percentage of patients who died, had a disabling stroke, or were rehospitalized for heart failure through 12 months was 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, -1.2 percentage points; 90% confidence interval [CI], -4.9 to 2.5; P<0.001 for noninferiority). The Kaplan-Meier estimate of the percentage of patients with bioprosthetic-valve dysfunction through 12 months was 9.4% with the self-expanding valve and 41.6% with the balloon-expandable valve (difference, -32.2 percentage points; 95% CI, -38.7 to -25.6; P<0.001 for superiority). The aortic-valve mean gradient at 12 months was 7.7 mm Hg with the self-expanding valve and 15.7 mm Hg with the balloon-expandable valve, and the corresponding values for additional secondary end points through 12 months were as follows: mean effective orifice area, 1.99 cm2 and 1.50 cm2; percentage of patients with hemodynamic structural valve dysfunction, 3.5% and 32.8%; and percentage of women with bioprosthetic-valve dysfunction, 10.2% and 43.3% (all P<0.001). Moderate or severe prosthesis-patient mismatch at 30 days was found in 11.2% of the patients in the self-expanding valve group and 35.3% of those in the balloon-expandable valve group (P<0.001). Major safety end points appeared to be similar in the two groups. CONCLUSIONS: Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.).

Clinical considerations and challenges in TAV-in-TAV procedures.

Transcatheter aortic valve replacement (TAVR) has emerged as a viable treatment for aortic valve disease, including low-risk patients. However, as TAVR usage increases, concerns about long-term durability and the potential for addition interventions have arisen. Transcatheter aortic valve (TAV)-in-TAV procedures have shown promise in selected patients in numerous registries, offering a less morbid alternative to TAVR explantation. In this review, the authors aimed to comprehensively review the experience surrounding TAV-in-TAV, summarize available data, discuss pre-procedural planning, highlight associated challenges, emphasize the importance of coronary obstruction assessment and provide insights into the future of this technique.

Clinical relevance of transcranial Doppler in a cardiac surgery setting: embolic load predicts difficult separation from cardiopulmonary bypass.

BACKGROUND: During cardiac surgery, transcranial Doppler (TCD) represents a non-invasive modality that allows measurement of red blood cell flow velocities in the cerebral arteries. TCD can also be used to detect and monitor embolic material in the cerebral circulation. Detection of microemboli is reported as a high intensity transient signal (HITS). The importance of cerebral microemboli during cardiac surgery has been linked to the increased incidence of postoperative renal failure, right ventricular dysfunction, and hemodynamic instability. The objective of this study is to determine whether the embolic load is associated with hemodynamic instability during cardiopulmonary bypass (CPB) separation and postoperative complications. METHODS: A retrospective single-centre cohort study of 354 patients undergoing cardiac surgery between December 2015 and March 2020 was conducted. Patients were divided in tertiles, where 117 patients had a low quantity of embolic material (LEM), 119 patients have a medium quantity of microemboli (MEM) and 118 patients who have a high quantity of embolic material (HEM). The primary endpoint was a difficult CPB separation. Multivariate logistic regression was used to determine the potential association between a difficult CPB separation and the number of embolic materials. RESULTS: Patients who had a difficult CPB separation had more HITS compared to patients who had a successful CPB separation (p < 0.001). In the multivariate analysis, patients with MEM decreased their odds of having a difficult CPB weaning compared to patients in the HEM group (OR = 0.253, CI 0.111-0.593; p = 0.001). In the postoperative period patients in the HEM group have a higher Time of Persistent Organ Dysfunction (TPOD), a longer stay in the ICU, a longer duration under vasopressor drugs and a higher mortality rate compared to those in the MEM and LEM groups. CONCLUSION: The result of this study suggests that a high quantity of cerebral embolic material increases the odds of having a difficult CPB separation. Also, it seems to be associated to more complex surgery, a longer CPB time, a higher TPOD and a longer stay in the ICU. Six out of eight patients who died in this cohort were in the HEM group.

TAVI-PREP: A Deep Learning-Based Tool for Automated Measurements Extraction in TAVI Planning.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to open-heart surgery for treating severe aortic stenosis. Despite its benefits, the risk of procedural complications necessitates careful preoperative planning. METHODS: This study proposes a fully automated deep learning-based method, TAVI-PREP, for pre-TAVI planning, focusing on measurements extracted from computed tomography (CT) scans. The algorithm was trained on the public MM-WHS dataset and a small subset of private data. It uses MeshDeformNet for 3D surface mesh generation and a 3D Residual U-Net for landmark detection. TAVI-PREP is designed to extract 22 different measurements from the aortic valvular complex. A total of 200 CT-scans were analyzed, and automatic measurements were compared to the ones made manually by an expert cardiologist. A second cardiologist analyzed 115 scans to evaluate inter-operator variability. RESULTS: High Pearson correlation coefficients between the expert and the algorithm were obtained for most parameters (0.90-0.97), except for left and right coronary height (0.8 and 0.72, respectively). Similarly, the mean absolute relative error was within 5% for most measurements, except for left and right coronary height (11.6% and 16.5%, respectively). A greater consensus was observed among experts than when compared to the automatic approach, with TAVI-PREP showing no discernable bias towards either the lower or higher ends of the measurement spectrum. CONCLUSIONS: TAVI-PREP provides reliable and time-efficient measurements of the aortic valvular complex that could aid clinicians in the preprocedural planning of TAVI procedures.

Outcomes After Transcatheter Mitral Valve Replacement According to Regurgitation Etiology.

BACKGROUND: Whether transcatheter mitral valve replacement (TMVR) devices perform similarly with respect to the underlying mitral regurgitation (MR) etiology remains unknown. The aim of the present analysis was to assess outcomes of TMVR according to the MR underlying etiology among the CHoice of OptImal transCatheter trEatment for Mitral Insufficiency (CHOICE-MI) registry. METHODS: Of 746 patients, 229 patients (30.7%) underwent TMVR. The study population was subdivided according to primary, secondary, or mixed MR. Patients with mitral annular calcification were excluded. The primary study endpoint was a composite endpoint of all-cause mortality or hospitalization for heart failure at 1 year. Secondary study endpoints were all-cause and cardiovascular mortality at 1 year, New York Heart Association functional class, and residual MR, both at discharge and 1 year. RESULTS: The predominant MR etiology was secondary MR (58.4%), followed by primary MR (28.7%) and mixed MR (12.9%). Technical success and procedural mortality were similar according to MR etiology. Discharge echocardiography revealed residual MR 2+ in 11.3%, 3.7%, and 5.3% of patients with primary, secondary, and mixed MR, respectively (P = .1). MR elimination was similar in all groups up to the 1-year follow-up. There was no difference in terms of primary combined outcome occurrence according to MR etiology. One-year all-cause mortality was reported in 28.8%, 24.2%, and 32.1% of patients with primary, secondary, and mixed MR, respectively (P = .07). CONCLUSIONS: In our study we did not find differences in short-term and 1-year outcomes after TMVR according to MR etiology.

Rationale and Design of the Randomized Bayesian Multicenter COME-TAVI Trial in Patients With a New Onset Left Bundle Branch Block.

Patients with new-onset left bundle branch block (LBBB) after transcatheter aortic valve implantation (TAVI) are at risk of developing delayed high-degree atrioventricular block. Management of new-onset LBBB post-TAVI remains controversial. In the Comparison of a Clinical Monitoring Strategy Versus Electrophysiology-Guided Algorithmic Approach in Patients With a New LBBB After TAVI (COME-TAVI) trial, consenting patients with new-onset LBBB that persists on day 2 after TAVI, meeting exclusion/inclusion criteria, are randomized to an electrophysiological study (EPS)-guided approach or 30-day electrocardiographic monitoring. In the EPS-guided approach, patients with a His to ventricle (HV) interval ≥ 65 ms undergo permanent pacemaker implantation. Patients randomized to noninvasive monitoring receive a wearable continuous electrocardiographic recording and transmitting device for 30 days. Follow-up will be performed at 3, 6, and 12 months. The primary endpoint is a composite outcome designed to capture net clinical benefit. The endpoint incorporates major consequences of both strategies in patients with new-onset LBBB after TAVI, as follows: (i) sudden cardiac death; (ii) syncope; (iii) atrioventricular conduction disorder requiring a pacemaker (for a class I or IIa indication); and (iv) complications related to the pacemaker or EPS. The trial incorporates a Bayesian design with a noninformative prior, outcome-adaptive randomization (initially 1:1), and 2 prespecified interim analyses once 25% and 50% of the anticipated number of primary endpoints are reached. The trial is event-driven, with an anticipated upper limit of 452 patients required to reach 77 primary outcome events over 12 months of follow-up. In summary, the aim of this Bayesian multicentre randomized trial is to compare 2 management strategies in patients with new-onset LBBB post-TAVI-an EPS-guided approach vs noninvasive 30-day monitoring. Trial registration number: NCT03303612.

Les patients chez qui un bloc de branche gauche (BBG) est récemment apparu à la suite de l'implantation valvulaire aortique par cathéter (IVAC) présentent un risque de bloc auriculoventriculaire de haut degré tardif. La prise en charge d'un BBG récemment apparu après une IVAC demeure controversée. Dans le cadre de l'essai COME-TAVI (Comparison of a ClinicalMonitoring Strategy VersusElectrophysiology-Guided Algorithmic Approach in Patients With a New LBBB AfterTAVI, ou comparaison d'une stratégie de surveillance clinique, par rapport à une approche guidée par étude électrophysiologique et fondée sur un algorithme, chez des patients présentant un BBG d'apparition récente à la suite d'une IVAC), des patients qui présentent un BBG d'apparition récente persistant le 2e jour après une IVAC, qui répondent aux critères d'admissibilité et qui ont donné leur consentement sont répartis aléatoirement pour être suivis à l'aide d'une approche guidée par une étude électrophysiologique (EEP) ou faire l'objet d'une surveillance électrocardiographique d'une durée de 30 jours. Un stimulateur cardiaque est implanté chez les patients du groupe de l'EEP dont l'intervalle HV (temps de conduction dans le tronc du faisceau de His jusqu'aux ventricules) est ≥ 65 ms. Les patients du groupe de surveillance non invasive reçoivent un dispositif portable d'enregistrement et de transmission continue de données électrocardiographiques pour une période de 30 jours. Le suivi sera réalisé aux 3e, 6e et 12e mois. Le critère d'évaluation principal est un paramètre composite conçu afin de saisir le bienfait clinique net. Il comprend les conséquences majeures des deux stratégies chez les patients présentant un BBG d'apparition récente après une IVAC, comme suit : (i) mort subite d'origine cardiaque; (ii) syncope; (iii) trouble de la conduction auriculoventriculaire nécessitant la pose d'un stimulateur cardiaque (pour une indication de classe I ou IIa); et (iv) complications relatives au stimulateur cardiaque ou à l'EEP. L'essai intègre une conception bayésienne avec une répartition aléatoire (dans un rapport initial de 1:1) antérieure non informative adaptée aux résultats et deux analyses intermédiaires définies au préalable lorsque 25 % et 50 % du nombre anticipé des critères d'évaluation principaux seront atteints. L'essai est axé sur les événements, et la limite supérieure anticipée pour atteindre 77 événements relatifs aux critères d'évaluation principaux sur 12 mois de suivi est de 452 patients. En résumé, l'objectif de cet essai bayésien multicentrique à répartition aléatoire est de comparer deux stratégies de prise en charge de patients présentant un BBG d'apparition récente après une IVAC, soit une approche guidée par une EEP, par rapport à une surveillance non invasive de 30 jours. Trial registration number: NCT03303612.

Impact of Valve Academic Research Consortium 3 (VARC-3) minor access site vascular complications in patients undergoing percutaneous transfemoral transcatheter aortic valve implantation.

OBJECTIVES: The aim of this study was to investigate the impact of Valve Academic Research Consortium 3 minor access site vascular complications (VCs) in patients who underwent percutaneous transfemoral (TF) transcatheter aortic valve implantation (TAVI). METHODS: This single-centre retrospective study included consecutive patients who underwent percutaneous TF-TAVI from 2009 to 2021. A propensity score-matched analysis was performed to compare early and long-term clinical results between patients with VC and without VC (nVC). RESULTS: A total of 2161 patients were included, of whom 284 (13.1%) experienced access site VC. Propensity score analysis allowed to match 270 patients from the VC group with 727 patients from the nVC group. In the matched cohorts, the VC group showed longer operative times (63.5 vs 50.0 min, P < 0.001), higher operative and in-hospital mortality (2.6% vs 0.7%, P = 0.022; and 6.3% vs 3.2%, P = 0.040, respectively), longer hospital length of stay (8 vs 7 days, P = 0.001) and higher rates of blood transfusion (20.4% vs 4.3%, P < 0.001) and infectious complications (8.9% vs 3.8%, P = 0.003). Overall survival during follow-up was significantly lower in the VC group (hazard ratio 1.37, 95% CI 1.03-1.82, P = 0.031) with 5-year survival rates being 58.0% (95% CI 49.5-68.0%) and 70.7% (95% CI 66.2-75.5%) for the VC and nVC groups, respectively. CONCLUSIONS: This retrospective study observed that minor access site VCs during percutaneous TF-TAVI can be serious events affecting early and long-term outcomes.

Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation: A Propensity Score-Matched Comparison.

BACKGROUND: Transcatheter mitral valve replacement (TMVR) is an emerging therapeutic alternative for patients with secondary mitral regurgitation (MR). Outcomes of TMVR versus guideline-directed medical therapy (GDMT) have not been investigated for this population. This study aimed to compare clinical outcomes of patients with secondary MR undergoing TMVR versus GDMT alone. METHODS: The CHOICE-MI registry (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency) included patients with MR undergoing TMVR using dedicated devices. Patients with MR pathogeneses other than secondary MR were excluded. Patients treated with GDMT alone were derived from the control arm of the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation). We compared outcomes between the TMVR and GDMT groups, using propensity score matching to adjust for baseline differences. RESULTS: After propensity score matching, 97 patient pairs undergoing TMVR (72.9±8.7 years; 60.8% men; transapical access, 91.8%) versus GDMT (73.1±11.0 years; 59.8% men) were compared. At 1 and 2 years, residual MR was ≤1+ in all patients of the TMVR group compared with 6.9% and 7.7%, respectively, in those receiving GDMT alone (both P<0.001). The 2-year rate of heart failure hospitalization was significantly lower in the TMVR group (32.8% versus 54.4%; hazard ratio, 0.59 [95% CI, 0.35-0.99]; P=0.04). Among survivors, a higher proportion of patients were in the New York Heart Association functional class I or II in the TMVR group at 1 year (78.2% versus 59.7%; P=0.03) and at 2 years (77.8% versus 53.2%; P=0.09). Two-year mortality was similar in the 2 groups (TMVR versus GDMT, 36.8% versus 40.8%; hazard ratio, 1.01 [95% CI, 0.62-1.64]; P=0.98). CONCLUSIONS: In this observational comparison, over 2-year follow-up, TMVR using mostly transapical devices in patients with secondary MR was associated with significant reduction of MR, symptomatic improvement, less frequent hospitalizations for heart failure, and similar mortality compared with GDMT. REGISTRATION: URL: https://clinicaltrials.gov; Unique identifier: NCT04688190 (CHOICE-MI) and NCT01626079 (COAPT).

Clinical outcomes of transcatheter mitral valve replacement: two-year results of the CHOICE-MI Registry.

BACKGROUND: Transcatheter mitral valve replacement (TMVR) using dedicated devices is an alternative therapy for high-risk patients with symptomatic mitral regurgitation (MR). AIMS: This study aimed to assess the 2-year outcomes and predictors of mortality in patients undergoing TMVR from the multicentre CHOICE-MI Registry. METHODS: The CHOICE-MI Registry included consecutive patients with symptomatic MR treated with 11 different dedicated TMVR devices at 31 international centres. The investigated endpoints included mortality and heart failure hospitalisation rates, procedural complications, residual MR, and functional status. Multivariable Cox regression analysis was applied to identify independent predictors of 2-year mortality. RESULTS: A total of 400 patients, median age 76 years (interquartile range [IQR] 71, 81), 59.5% male, EuroSCORE II 6.2% (IQR 3.8, 12.0), underwent TMVR. Technical success was achieved in 95.2% of patients. MR reduction to ≤1+ was observed in 95.2% at discharge with durable results at 1 and 2 years. New York Heart Association Functional Class had improved significantly at 1 and 2 years. All-cause mortality was 9.2% at 30 days, 27.9% at 1 year and 38.1% at 2 years after TMVR. Chronic obstructive pulmonary disease, reduced glomerular filtration rate, and low serum albumin were independent predictors of 2-year mortality. Among the 30-day complications, left ventricular outflow tract obstruction, access site and bleeding complications showed the strongest impact on 2-year mortality. CONCLUSIONS: In this real-world registry of patients with symptomatic MR undergoing TMVR, treatment with TMVR was associated with a durable resolution of MR and significant functional improvement at 2 years. Two-year mortality was 38.1%. Optimised patient selection and improved access site management are mandatory to improve outcomes.

Transcatheter Aortic Valve Replacement in Patients With Reduced Ejection Fraction and Nonsevere Aortic Stenosis.

BACKGROUND: The potential benefit of transcatheter aortic valve replacement (TAVR) in patients with nonsevere aortic stenosis (AS) and heart failure is controversial. This study aimed to assess outcomes of patients with nonsevere low-gradient AS (LGAS) and reduced left ventricular ejection fraction undergoing TAVR or medical management. METHODS: Patients undergoing TAVR for LGAS and reduced left ventricular ejection fraction (<50%) were included in a multinational registry. True-severe low-gradient AS (TS-LGAS) and pseudo-severe low-gradient AS (PS-LGAS) were classified according to computed tomography-derived aortic valve calcification thresholds. A medical control group with reduced left ventricular ejection fraction and moderate AS or PS-LGAS was used (Medical-Mod). Adjusted outcomes between all groups were compared. Among patients with nonsevere AS (moderate or PS-LGAS), outcomes after TAVR and medical therapy were compared using propensity score-matching. RESULTS: A total of 706 LGAS patients undergoing TAVR (TS-LGAS, N=527; PS-LGAS, N=179) and 470 Medical-Mod patients were included. After adjustment, both TAVR groups showed superior survival compared with Medical-Mod patients (all P<0.001), while no difference was found between TS-LGAS and PS-LGAS TAVR patients (P=0.96). After propensity score-matching among patients with nonsevere AS, PS-LGAS TAVR patients showed superior 2-year overall (65.4%) and cardiovascular survival (80.4%) compared with Medical-Mod patients (48.8% and 58.5%, both P≤0.004). In a multivariable analysis including all patients with nonsevere AS, TAVR was an independent predictor of survival (hazard ratio, 0.39 [95% CI, 0.27-0.55]; P<0.0001). CONCLUSIONS: Among patients with nonsevere AS and reduced left ventricular ejection fraction, TAVR represents a major predictor of superior survival. These results reinforce the need for randomized-controlled trials comparing TAVR versus medical management in heart failure patients with nonsevere AS. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04914481.

Extracorporeal membrane oxygenation and microaxial left ventricular assist device in cardiogenic shock: Choosing the right mechanical circulatory support to improve outcomes.

Objective: To evaluate the outcomes of patients supported with Impella (CP/5.0) or venoarterial extracorporeal membrane oxygenation (VA-ECMO) for cardiogenic shock according to shock phenotype. The primary end point was 30-day survival. Methods: A retrospective study of patients supported with Impella (CP/5.0) or VA-ECMO between 2010 and 2020 was performed. Patients were grouped according to 1 of 2 shock phenotypes: isolated left ventricular (LV) dysfunction versus biventricular dysfunction or multiple organ failure (MOF). The local practice favors Impella for isolated LV dysfunction and VA-ECMO for biventricular dysfunction or MOF. Results: Among the 75 patients included, 17 (23%) had isolated LV dysfunction. Patients with biventricular dysfunction or MOF had a greater median lactate level compared with those with isolated LV dysfunction (7.9 [2.9-11.8] vs 3.8 [1.1-5.8] mmol/L, respectively). Among patients with isolated LV dysfunction, 30-day survival was 46% for the Impella group (n = 13) and 75% for VA-ECMO (n = 4). Among patients with biventricular dysfunction or MOF, 30-day survival was 9% for the Impella group (n = 11) and 28% for VA-ECMO (n = 47). Patients supported with Impella 5.0 had better 30-day survival compared with those supported with Impella CP, for both shock phenotypes (83% vs 14% and 14% vs 0%, respectively). Conclusions: In this small cohort, patients supported with Impella for isolated LV dysfunction and VA-ECMO for biventricular dysfunction or MOF had acceptable survival at 30 days. Patients with biventricular dysfunction or MOF who were supported by Impella had the lowest survival rates. Patients with isolated LV dysfunction who were supported with VA-ECMO had good 30-day survival.

Explant vs Redo-TAVR After Transcatheter Valve Failure: Mid-Term Outcomes From the EXPLANTORREDO-TAVR International Registry.

BACKGROUND: Valve reintervention after transcatheter aortic valve replacement (TAVR) failure has not been studied in detail. OBJECTIVES: The authors sought to determine outcomes of TAVR surgical explantation (TAVR-explant) vs redo-TAVR because they are largely unknown. METHODS: From May 2009 to February 2022, 396 patients in the international EXPLANTORREDO-TAVR registry underwent TAVR-explant (181, 46.4%) or redo-TAVR (215, 54.3%) for transcatheter heart valve (THV) failure during a separate admission from the initial TAVR. Outcomes were reported at 30 days and 1 year. RESULTS: The incidence of reintervention after THV failure was 0.59% with increasing volume during the study period. Median time from index-TAVR to reintervention was shorter in TAVR-explant vs redo-TAVR (17.6 months [IQR: 5.0-40.7 months] vs 45.7 months [IQR: 10.6-75.6 months]; P < 0.001], respectively. TAVR-explant had more prosthesis-patient mismatch (17.1% vs 0.5%; P < 0.001) as the indication for reintervention, whereas redo-TAVR had more structural valve degeneration (63.7% vs 51.9%; P = 0.023), with a similar incidence of ≥moderate paravalvular leak between groups (28.7% vs 32.8% in redo-TAVR; P = 0.44). There was a similar proportion of balloon-expandable THV failures (39.8% TAVR-explant vs 40.5% redo-TAVR; P = 0.92). Median follow-up was 11.3 (IQR: 1.6-27.1 months) after reintervention. Compared with redo-TAVR, TAVR-explant had higher mortality at 30 days (13.6% vs 3.4%; P < 0.001) and 1 year (32.4% vs 15.4%; P = 0.001), with similar stroke rates between groups. On landmark analysis, mortality was similar between groups after 30 days (P = 0.91). CONCLUSIONS: In this first report of the EXPLANTORREDO-TAVR global registry, TAVR-explant had a shorter median time to reintervention, with less structural valve degeneration, more prosthesis-patient mismatch, and similar paravalvular leak rates compared with redo-TAVR. TAVR-explant had higher mortality at 30 days and 1 year, but similar rates on landmark analysis after 30 days.

Transcatheter valvular therapies in patients with left ventricular assist devices.

Aortic, mitral and tricuspid valve regurgitation are commonly encountered in patients with continuous-flow left ventricular assist devices (CF-LVADs). These valvular heart conditions either develop prior to CF-LVAD implantation or are induced by the pump itself. They can all have significant detrimental effects on patients' survival and quality of life. With the improved durability of CF-LVADs and the overall rise in their volume of implants, an increasing number of patients will likely require a valvular heart intervention at some point during CF-LVAD therapy. However, these patients are often considered poor reoperative candidates. In this context, percutaneous approaches have emerged as an attractive "off-label" option for this patient population. Recent data show promising results, with high device success rates and rapid symptomatic improvements. However, the occurrence of distinct complications such as device migration, valve thrombosis or hemolysis remain of concern. In this review, we will present the pathophysiology of valvular heart disease in the setting of CF-LVAD support to help us understand the underlying rationale of these potential complications. We will then outline the current recommendations for the management of valvular heart disease in patients with CF-LVAD and discuss their limitations. Lastly, we will summarize the evidence related to transcatheter heart valve interventions in this patient population.

Novel Humanized Biosimulator to Predict Coronary Obstruction in High-Risk Valve-in-Valve Procedures.

We developed humanized biosimulator to predict the risk of coronary obstruction among high-risk patients undergoing valve-in-valve (ViV) procedures. In this case, based on unchanged instantaneous wave-free ratio values measured during a ViV simulation session, the procedure was performed safely in the patient the day afterward, without coronary artery issues and with good hemodynamic results. (Level of Difficulty: Advanced.).

Clinical Characteristics and Outcomes of Patients Screened for but Deemed Clinically Not Suitable for Transcatheter Mitral Valve Replacement: DECLINE-TMVR Registry.

BACKGROUND: Transcatheter therapies are a recognized alternative intervention in patients with severe mitral regurgitation who are at high surgical risk. The purpose of this study was to characterize patients screened for transcatheter mitral valve replacement (TMVR), establish the clinical and anatomic reasons for unsuitability, and determine clinical course and early outcomes. METHODS: International multicentre registry was conducted of consecutive patients screened for TMVR at 12 centres in Europe, the United States, and Canada between April 2015 and September 2018. Patient-level retrospective data were collected for all patients screened. RESULTS: From a total of 294 patients, 87 (30%) patients were suitable for and underwent TMVR, whereas 207 (70%) patients were unsuitable for TMVR. There was no difference in Society of Thoracic Surgeons predicted risk of mortality (6.3% ± 4.3% vs 6.7 ± 6.1%, P = 0.52) for mitral valve replacement between the groups. The most common reasons for TMVR unsuitability were mitral annular size outside therapeutic range (28%) and small predicted neo-LVOT (25%). Preprocedural multidetector computed tomographic demonstrated that patients unsuitable for TMVR had smaller predicted neo-left ventricular outflow tract (LVOT) area (318 ±192 mm2 vs 495 ± 202 mm2, P = 0.04). At 30 days, there was no difference in rates of rehospitalization (8% vs 8%, P = 0.21), stroke (1% vs 2%, P = 0.42), or mortality (4% vs 10%, P = 0.10), unadjusted for procedural risk, between unsuitable for TMVR and TMVR groups, respectively. CONCLUSIONS: Two-thirds of patients failed screening as anatomically unsuitable for TMVR. The findings of this study have important clinical implications, highlighting an unmet clinical need and provide a target for design innovation in future iterations of TMVR devices.

Impact of clinical variables on outcomes in refractory cardiac arrest patients undergoing extracorporeal cardiopulmonary resuscitation.

Background: In the past two decades, extracorporeal resuscitation (ECPR) has been increasingly used in the management of refractory cardiac arrest (CA) patients. Decision algorithms have been used to guide the care such patients, but the effectiveness of such decision-making tools is not well described. The aim of this study was to compare the rate of survival with a good neurologic outcome of patients treated with ECPR meeting all criteria of a clinical decision-making tool for the initiation of ECPR to those for whom ECPR was implemented outside of the algorithm. Methods: All patients who underwent E-CPR between January 2014 and December 2021 at the Montreal Heart Institute were included in this retrospective analysis. We dichotomized the cohort according to adherence or non-adherence with the ECPR decision-making tool, which included the following criteria: age ≤65 years, initial shockable rhythm, no-flow time <5 min, serum lactate <13 mmol/L. Patients were included in the "IN" group when they met all criteria of the decision-making tool and in the "OUT" group when at least one criterion was not met. Main outcomes and measures: The primary outcome was survival with intact neurological status at 30 days, defined by a Cerebral Performance Category (CPC) Scale 1 and 2. Results: A total of 41 patients (IN group, n = 11; OUT group, n = 30) were included. A total of 4 (36%) patients met the primary outcome in the IN group and 7 (23%) in the OUT group [odds ratio (OR): 1.88 (95% CI, 0.42-8.34); P = 0.45]. However, survival with a favorable outcome decreased steadily with 2 or more deviations from the decision-making tool [2 deviations: 1 (11%); 3 deviations: 0 (0%)]. Conclusion and relevance: Most patients supported with ECPR fell outside of the criteria encompassed in a clinical decision-making tool, which highlights the challenge of optimal selection of ECPR candidates. Survival rate with a good neurologic outcome did not differ between the IN and OUT groups. However, survival with favorable outcome decreased steadily after one deviation from the decision-making tool. More studies are needed to help select proper candidates with refractory CA patients for ECPR.

Key questions about aortic insufficiency in patients with durable left ventricular assist devices.

The development of the latest generation of durable left ventricular assist devices (LVAD) drastically decreased adverse events such as pump thrombosis or disabling strokes. However, time-related complications such as aortic insufficiency (AI) continue to impair outcomes following durable LVAD implantation, especially in the context of long-term therapy. Up to one-quarter of patients with durable LVAD develop moderate or severe AI at 1 year and its incidence increases with the duration of support. The continuous regurgitant flow within the left ventricle can compromise left ventricular unloading, increase filling pressures, decrease forward flow and can thus lead to organ hypoperfusion and heart failure. This review aims to give an overview of the epidemiology, pathophysiology, and clinical consequences of AI in patients with durable LVAD.