Composite Endpoint Of Death Research Articles

Sex Differences Among Patients Undergoing Transcatheter Tricuspid Valve Repair Using the Edge-to-Edge Technique.

Tricuspid valve regurgitation (TR) is more prevalent among females. Transcatheter tricuspid valve repair (TTVR) using the edge-to-edge technique represents an alternative to surgery in patients with severe TR and high surgical risk. This study aims to investigate sex differences among patients undergoing TTVR. All patients who underwent TTVR at our center were retrospectively included. We compared baseline characteristics, intra-hospital, and one-year outcomes between males and females. A total of 105 consecutive patients underwent TTVR. Females were more prevalent in the study cohort (n = 63, 60%). Coronary artery disease (CAD) was more evident in males than females (71.4% vs. 47.6%, p = 0.016). Left ventricular ejection fraction (LVEF) was also worse in males (48.8 ± 13.4 vs. 58 ± 6.8, p < 0.001). Other clinical characteristics were similar between both groups. The Success of the procedure (88.1% vs. 95.2%, p = 0.177) and intra-hospital mortality (4.8% vs. 11.1%, p = 0.255) were similar among males and females. At one-year follow-up, mortality was similar between both groups (24.3% vs. 25.9%, p = 0.863). Furthermore, hospitalization due to acute heart failure was also similar between both groups (40.5% vs. 37.5%, p = 0.768), as was a composite endpoint of death or hospitalization. In patients with successful procedures and who survived one year, TR severity was comparable between both groups. In our real-world cohort, more females underwent TTVR than males. No difference was observed in outcomes between males and females at one-year follow-up.

Complete versus culprit-only coronary revascularization in patients with myocardial infarction and multivessel disease undergoing percutaneous coronary intervention: an updated meta-analysis.

Recently, the FFR-Guidance for Complete Nonculprit Revascularization (FULL REVASC) trial in ST elevation myocardial infarction (STEMI) patients with multiple vessel disease (MVD) did not show differences in the composite endpoint of death from any cause, myocardial infarction, or unplanned revascularization than culprit-lesion-only percutaneous coronary intervention (PCI) at 4.8 years, although complete revascularization is a recommendation IA in current guidelines. We want to determine through an updated meta-analysis whether complete revascularization is associated with decreased mortality and hard clinical endpoints compared to culprit lesion only PCI. We searched MEDLINE, Embase, ISI Web of Science, and Cochrane Central Register of Controlled Trials) from January 1990 to April 2024 using the terms "percutaneous coronary intervention" combined with "non culprit lesions" or "culprit lesion" or "complete revascularization" or "incomplete revascularization." Additionally, a "snowball search" was conducted. Only randomized clinical trials (RCT) reporting mortality, re-infarction or new revascularization after at least 12 months and using predominantly drug eluting stents were included. The summary effect of different revascularization strategies on cardiovascular endpoints was estimated and measures of effect size were expressed as odds ratios (ORs). Eight RCT involving 9515 patients were included, with a follow-up range between 12 months and 4.8 years. Main findings show that culprit lesion revascularization was associated with an increased risk of MI (OR: 1.38; 95% CI: 1.05 to 1.81, I2 42%) and ischemia-guided revascularization (OR: 2.81; 95% CI: 1.86 to 4.26, I2 80%) compared to complete revascularization, without differences in overall mortality (OR: 1.15; 95% CI: 0.98 to 1.36, I2 2%). In patients with STEMI and MVD without cardiogenic shock, our metanalysis showed that complete revascularization with PCI significantly reduced the risk of non-fatal myocardial reinfarction and ischemic-driven revascularization compared to culprit vessel-only revascularization, without differences in overall mortality.

Incidence, determinants, and impact of in-hospital complications during percutaneous patent foramen ovale closure

Abstract Introduction The incidence, types, determinants, and clinical impact of in-hospital complications after contemporary patent foramen ovale (PFO) percutaneous closure is unclear. Purpose To describe the incidence, types, determinants, and clinical impact of in-hospital complications after percutaneous PFO closure. Methods This study included consecutive patients undergoing PFO percutaneous closure for any indication in 18 centers in France and Italy from the ongoing AIR-FORCE registry. Periprocedural complications were collected, including death, bleeding, myocardial infarction (MI), supraventricular arrhythmia, pericardial effusion or tamponade, cardiac perforation, device embolization, intracardiac thrombus, venous thrombosis, atrioventricular block, brachial paraesthesia, oesophageal hematoma, and veno-arterial fistula. Determinants of periprocedural complications were evaluated using a logistic multivariate model. The clinical impact of periprocedural complications on cardiovascular events after discharge measured by the composite endpoint of death, stroke, transient ischemic attack, MI atrial arrhythmia, pulmonary embolism, deep veinous thrombosis, BARC ≥2 bleeding, or percutaneous or surgical re-intervention on the PFO) at longest follow-up was evaluated using a Cox model adjusted on age, sex, body mass index, diabetes mellitus, hypertension, dyslipidemia, and shunt severity prior to closure. Results We analyzed a total of 2,799 patients undergoing PFO closure with median age 50.7 [41.7-58.6] years and 57.9% male. A total of 109 (3.9% 95%CI 3.2%-4.7%) patients presented at least one in-hospital complication, the most frequent being supraventricular arrhythmia in 39 (1.4% 95%CI 1.0-1.9%) patients and BARC bleeding type ≥2 in 26 (0.9% 95%CI 0.6-1.4%) patients. Determinants of in-hospital complications were older age (per on year aOR 1.02 95%CI 1.01-1.04), diabetes mellitus (aOR 2.58 95%CI 1.36-4.89) and PFO closure for secondary prevention of an arterial embolic event (aOR 2.12 95%CI 1.18-3.82). With a median follow-up of 1.1 [0.3-3.1] years, the occurrence of an in-hospital complication was associated with an increased risk of cardiovascular events after discharge (aHR 1.90 95%CI 1.26-2.89) (Figure 1). Conclusions Although relatively rare, the occurrence of in-hospital complication during PFO percutaneous closure is associated with an increased risk of cardiovascular events in the year following the procedure.

Long-term outcome after Mustard procedure at young age: longitudinal follow-up of 40 to 48 years after surgery

Abstract Objectives To evaluate the long-term clinical outcome and quality of life up to 48 years of patients with Transposition of the Great Arteries (TGA) after Mustard procedure at young age. Primary outcome was defined as a composite endpoint of death, re-intervention, clinically relevant heart failure or arrhythmia, ischemic stroke and endocarditis. Methods Single center, longitudinal cohort study evaluating consecutive patients with TGA who underwent Mustard procedure before the age of 15 between 1973 and 1980 at our medical center, the Netherlands. Survival of all eligible patients was obtained. All eligible patients were invited for in hospital evaluation and underwent extensive cardiac and psychological evaluation every 10 years. The latest evaluation took place in 2021 and 2022. Results The original study cohort consisted of 91 consecutive patients. Cumulative survival at 48 years (95% complete) was 62% and significantly decreased compared to the general Dutch population (p&amp;lt;0.001). Cumulative survival at 48 years in hospital survivors was 66%. Mortality rate was 0.19 per 100 patient-years. Thirty-four patients (77%) of the eligible 44 survivors (71% male, median age at study 46 years) were included in the present study. Median follow-up since initial surgical correction was 46 (range 40-48) years. Event-free survival at 48 years was 14%. Overall, 34 patients underwent re-intervention of which 3 in the last 10 years (predominantly Baffle revision). In total, 29 patients had supraventricular tachycardia and 11 patients had ventricular tachycardia of which 8 and 4 respectively occurred in the last 10 years. Alltogether, 22 patients had symptomatic heart failure of which 9 occurred in the last 10 years. Cardiac magnetic resonance imaging (n=11) showed a median systemic right ventricular ejection fraction (sRVEF) of 35% [32-40%]. In 73% of the patients, sRVEF fraction was below 40%. Echocardiography showed a diminished sRVEF in all patients. VO2max was reduced in 95% of all patients. Self-perceived quality of life (SF-36) generally was comparable to the general Dutch population with the exception of domain general health (p&amp;lt;0.001). Conclusion Late mortality, and especially morbidity of hospital survivors after Mustard procedure was substantial, with an event free survival of only 14% at 48 years. Re-intervention and symptomatic arrhythmia were often reported. The function of the systemic right ventricle was diminished and VO2max was also reduced. The burden of heart failure increased drastically in the last decade. Therefore, intensive follow-up of these patients is warranted.

Imaging characteristics and clinical outcomes of hemodialysis vs. non-hemodialysis patients undergoing transcatheter aortic valve replacement: a Japanese single-center experience.

In 2021, Japan approved transcatheter aortic valve replacement (TAVR) for end-stage renal disease patients on hemodialysis (ESRD-HD). Yet, clinical/anatomical differences and outcomes between patients with and without ESRD-HD remain underexplored. This single-center study enrolled consecutive patients who underwent TAVR with the SAPIEN 3 between 2021 and 2023. Baseline characteristics and outcomes up to 1year were compared. Inverse probability treatment weighting (IPTW) approach and Cox regression were used. Among 287 eligible patients, 59 had ESRD-HD. Patients with ESRD-HD were predominantly male (59.2% vs. 40.7%; p = 0.01), younger (78.0 [73.5-83.5] vs. 84.0 [79.8-88.0]; < 0.001), with lower body mass index (21.4 [19.6-23.3] vs. 22.9 [20.3-25.3]; p = 0.02], higher surgical risk (Society of Thoracic Surgeons Predicted Risk of Mortality ≧8%: 28 [47.5%] vs. 34 [14.9%]; p < 0.001), and more peripheral artery disease (25.4% vs. 4.8%; p < 0.001). Patients with ESRD-HD had a significantly higher prevalence of severely calcified femoral arteries (12.5% vs. 2.6%; p < 0.001). However, there were no differences in the computed-tomographic (CT) anatomical characteristics of the aortic valve complex (AVC), including the aortic valve calcium score (1995 [1372-3374] vs. 2195 [1380-3172]; p = 0.65) or the presence of moderate or severe left ventricular outflow tract calcification (4.3% vs. 5.2%; p > 0.99). Major vascular complications were rare, and technical (98.3% vs. 98.7%; p > 0.99) and device success (75.9% vs. 82.4%; p = 0.26) rates were high in both. At 1year, there were no significant differences in a composite endpoint of death, stroke, major bleeding, or myocardial infarction (32.4% vs. 33.2%; HR 1.12; 95% CI 0.45-2.80; p = 0.81), nor its components after baseline adjustment.

Liberal versus restrictive transfusion strategies in acute myocardial infarction: a systematic review and comparative frequentist and Bayesian meta-analysis of randomized controlled trials

BackgroundThe transfusion strategy in the acute phase of myocardial infarction (AMI) remains a debated topic with non-standardized guidelines. This study aimed to evaluate the impact of liberal versus restrictive transfusion strategies on mortality during AMI.MethodsA systematic search was conducted across MEDLINE, EMBASE, and the COCHRANE library databases, focusing on randomized controlled trials (RCTs). The primary endpoint was the latest measured mortality within 90 days following myocardial infarction (MI). Secondary endpoints included recurrence of MI, cardiovascular mortality, stroke occurrence, unplanned revascularization, and a composite endpoint of death or recurrent MI. Mixed and random-effects models were employed to estimate relative risks. Sensitivity analyses were conducted using two approaches: one incorporating only studies assessed as low risk of bias according to the Rob2 tool, and another employing a Bayesian analysis.ResultsFour RCTs including a total of 4324 participants were analyzed. Neither the fixed-effect nor random-effects models demonstrated a significant reduction in mortality, with risk ratios (RR) of 1.16 (95% CI 0.95–1.40) for the fixed-effect model and 1.13 (95% CI 0.67–1.91) for the random-effects model (GRADE: low certainty of evidence). Sensitivity analyses, including the exclusion of two high-risk-of-bias studies and a Bayesian analysis, were consistent with the primary analysis. For the composite outcome death or MI both fixed-effect and random-effects models showed a statistically significant RR of 1.18 (95% CI 1.01–1.37) with negligible heterogeneity (I2 = 0%, p = 0.46), indicating results unfavorable to restrictive transfusion (GRADE: very low certainty of evidence). However, this result was primarily driven by a single study. For cardiac mortality, the fixed-effects model indicated a significant RR of 1.42 (95% CI 1.07–1.88), whereas the random-effects model showed non-significant RR of 1.05 (95% CI 0.36–3.80). Analyses of other secondary endpoints did not show statistically significant results.ConclusionsOur analysis did not demonstrate a significant benefit in early mortality with a liberal transfusion strategy compared to a restrictive strategy for AMI, low certainty of evidence. Liberal transfusion may reduce the risk of the composite outcome death or MI, with very low certainty of evidence. These findings should be interpreted with caution in critically ill patients.

Lung-Protective Mechanical Ventilation in Patients with Severe Acute Brain Injury: A Multicenter Randomized Clinical Trial (PROLABI).

Rationale: Lung-protective strategies using low Vt and moderate positive end-expiratory pressure (PEEP) are considered best practice in critical care, but interventional trials have never been conducted in patients with acute brain injuries because of concerns about carbon dioxide control and the effect of PEEP on cerebral hemodynamics. Objectives: To test the hypothesis that ventilation with lower VT and higher PEEP compared to conventional ventilation would improve clinical outcomes in patients with acute brain injury. Methods: In this multicenter, open-label, controlled clinical trial, 190 adult patients with acute brain injury were assigned to receive either a lung-protective or a conventional ventilatory strategy. The primary outcome was a composite endpoint of death, ventilator dependency, and acute respiratory distress syndrome (ARDS) at Day 28. Neurological outcome was assessed at ICU discharge by the Oxford Handicap Scale and at 6 months by the Glasgow Outcome Scale. Measurements and Main Results: The two study arms had similar characteristics at baseline. In the lung-protective and conventional strategy groups, using an intention-to-treat approach, the composite outcome at 28 days was 61.5% and 45.3% (relative risk [RR], 1.35; 95% confidence interval [CI], 1.03-1.79; P = 0.025). Mortality was 28.9% and 15.1% (RR, 1.91; 95% CI, 1.06-3.42; P = 0.02), ventilator dependency was 42.3% and 27.9% (RR, 1.52; 95% CI, 1.01-2.28; P = 0.039), and incidence of ARDS was 30.8% and 22.1% (RR, 1.39; 95% CI, 0.85-2.27; P = 0.179), respectively. The trial was stopped after enrolling 190 subjects because of termination of funding. Conclusions: In patients with acute brain injury without ARDS, a lung-protective ventilatory strategy, as compared with a conventional strategy, did not reduce mortality, percentage of patients weaned from mechanical ventilation, or incidence of ARDS and was not beneficial in terms of neurological outcomes. Because of the early termination, these preliminary results require confirmation in larger trials. Clinical trial registered with www.clinicaltrials.gov (NCT01690819).

Impact of Operator Experience on Left Atrial Appendage Occlusion Outcomes

BackgroundThe relationship between long-term outcomes and operator experience for left atrial appendage occlusion (LAAO) is still unknown. ObjectivesThis study sought to explore the association between operator LAAO experience and one-year clinical outcomes. MethodsThe RECORD study (Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology; NCT03917563) was a multicenter, prospective registry that included patients with the WATCHMAN LAAO device (Boston Scientific) in China from April 1, 2019, to October 31, 2020. The current analyses included patients with solely LAAO from the registry; those who had concomitant LAAO and ablation/other procedures were excluded. The primary outcome was a composite endpoint of death, stroke, systemic embolism, and Bleeding Academic Research Consortium (BARC)-defined type 3 or 5 bleeding at 1 year. ResultsA total of 1,547 LAAO patients and 111 operators were included. The mean CHA2DS2-VASc and HAS-BLED scores of patients were 4.0 ± 1.8 and 2.5 ± 1.1, respectively. The mean age of operators was 47.0 ± 7.2 years, 15 (13.5%) were female, and 52 (46.8%) were electrophysiologists. Utilizing maximally selected log-rank statistics, the thresholds to categorize an experienced operator were performing ≥32 LAAOs annually or ≥134 LAAOs in total. Performing ≥32 LAAOs annually is the better criterion than ≥134 LAAOs in total (absolute net reclassification index: 25.79%; P < 0.001). Compared with the ≥32 LAAO annually group, the <32 group was associated with a 1.8-fold (HRadjusted: 1.79; 95% CI: 1.16-2.78; P = 0.009) increase in the risk of the primary endpoint, and such risk in the <32 group can be reduced by ∼12% after performing each additional 5 cases (HRadjusted per 5 cases: 0.88; 95% CI: 0.78-0.99; P = 0.033). ConclusionsPerforming ≥32 LAAOs annually could be a threshold to categorize an experienced operator. Before reaching this threshold, the risk of death, stroke, systemic embolism, and BARC-defined type 3 or 5 bleeding decreased by 12% after every 5 cases performed.

Long-term outcomes of left bundle branch area pacing compared with right ventricular pacing in TAVI patients

BackgroundNew-onset permanent pacemaker implantation (PPMI) is still a common complication after transcatheter aortic valve implantation (TAVI) with adverse clinical outcomes. ObjectiveThe purpose of this study was to investigate whether left bundle branch area pacing (LBBAP) improves long-term clinical results compared with traditional right ventricular pacing (RVP) in patients requiring PPMI after TAVI. MethodsA total of 237 consecutive patients undergoing RVP (N = 117) or LBBAP (N = 120) after TAVI were retrospectively included. Long-term outcomes, including all-cause death, heart failure rehospitalization (HFH), and left ventricular ejection fraction (LVEF) change compared to baseline, were obtained until 5 years post-TAVI. ResultsThe mean age of the overall population was 74 years, with a mean surgical risk score of 4.4%. The paced QRS duration was significantly longer in the RVP group compared with the LBBAP group (151 ± 18 vs 122 ± 12 ms; P < .001). No difference was found between the 2 groups in all-cause death (13.7% vs 13.3%; adjusted hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.37–1.58; P = .466) or the composite endpoint of death and HFH (29.9% vs 19.2%; adjusted HR, 1.22; 95% CI, 0.70–2.13; P = .476); however, the risk of HFH was significantly higher in the RVP group at 5 years after TAVI (21.4% vs 7.5%; adjusted HR, 2.26; 95% CI, 1.01–5.08; P = .048). There was greater improvement of LVEF over time in the LBBAP group (P = .046 for LVEF changes over time between groups). ConclusionsLBBAP improved long-term clinical outcomes compared with RVP in patients undergoing PPMI after TAVI in terms of less HFH and better LVEF improvement.

Outcomes in Cardiac Transthyretin Amyloidosis and Association With New York Heart Association Class: Real-World Data.

Results from ATTR-ACT (Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy)indicate that tafamidis prolongs survival and reduces cardiovascular hospitalizations in cardiac transthyretin amyloidosis (ATTR-CA). However, real-world data supporting these findings are scarce. Thus, we sought to characterize the clinical outcome of patients with ATTR-CA treated with tafamidis in a real-world setting and assess the prognostic role of the New York Heart Association (NYHA) classification. We conducted a retrospective observational study, enrolling a consecutive sample of patients with ATTR-CA (wild-type or variant) treated with tafamidis. Clinical outcome was tracked through follow-up visits or phone calls. Primary outcomes were death and major adverse cardiac events (MACE), a composite end point of death and hospitalizations for acute cardiac decompensation, myocardial infarction, severe arrythmias, or stroke. Kaplan-Meier analysis estimated overall and MACE-free survival including NYHA subgroups (NYHA I/II versus NYHA III). One hundred sixty-seven patients with ATTR-CA (94.6% wild-type) were enrolled and followed for a median of 539 [323-869] days. Median overall survival was not reached. Estimated 1-year, 2-year, and 5-year overall survival among the whole cohort was 93.5%, 85.9%, and 70.2%, respectively. Overall survival was higher in the NYHA I/II subgroup (P=0.002). Median MACE-free survival time was 1082 (95% CI, 962-1202) days. MACE-free survival was higher in the NYHA I/II subgroup (P<0.001). With respective hazard ratios of 5.85 (95% CI, 1.48-23.18; P=0.012) and 3.95 (95% CI, 1.99-7.84; P<0.001), NYHA III was an independent predictor of death and MACE. Treatment of ATTR-CA with tafamidis led to substantial improvements of clinical outcome. NYHA classification at treatment initiation is a reliable tool to provide patients with individualized prognostic information.

The Impact of Transcatheter Aortic Valve Implantation on Health Care Costs and Clinical Outcomes Based on Frailty Risk: A Nationwide Cohort Analysis

BackgroundTranscatheter aortic valve implantation (TAVI) is preferred for treating severe aortic stenosis in older, frail populations, yet the impact of frailty on economic and clinical outcomes of TAVI is not well studied. MethodsThis retrospective cohort study included 2175 TAVI patients from 2015 to 2019, using Korea's National Health Insurance Service database, stratifying patients into low, intermediate, and high-frailty groups, using the Hospital Frailty Risk Score (HFRS). Health care costs, admissions, and total length of hospitalization were analyzed using Wilcoxon-rank test 12 months pre- and post-TAVI. Composite endpoint of death, stroke, and major bleeding, with individual outcomes, were compared using χ2 tests and Kaplan-Meier analysis. ResultsMean age was 80.2 years, and 47.3% were male; 747 (34.3%) were low frailty, 1159 (53.3%) were moderate frailty, and 269 (12.4%) were high frailty. After TAVI, medical costs decreased in the intermediate- (pre-TAVI: 2,269,000 KRW [$1668 USD], post-TAVI: 1,607,000 KRW [$1181 USD]; P < 0.001) and high-frailty groups (pre-TAVI: 3,949,000 KRW [$2904 USD], post-TAVI: 2,188,000 KRW [$1609 USD]; P < 0.001). All frailty groups had shorter length of hospital stay post-TAVI (26 to 21 days in the low-frailty, 44 to 31 days in the intermediate-frailty, and 65 to 41 days in the high-frailty group; all P <0.001). The composite outcome was higher in the frailer groups (27.8% in the low-frailty vs 31.5% in the intermediate-frailty vs 37.9% in the high-frailty group; P = 0.008). All groups showed comparable rates of cardiovascular death, stroke, or bleeding. ConclusionsTAVI is clinically viable and cost-saving treatment option for frail patients with severe aortic stenosis.

Comparison of peri-device sealing and procedural outcome after LAA closure in patients with and without isolated left atrial appendage

Abstract Background Catheter-based electrical isolation of the left atrial appendage (LAA) is increasingly performed in patients with symptomatic atrial fibrillation (AF) not responding to pulmonary vein isolation (PVI). Since the electrically isolated LAA is known to be susceptible to thromboembolism, endovascular LAA occlusion (LAAO) is increasingly being used. Objective We performed a procedural and clinical outcome analysis over 12 months in patients receiving two different LAAO device systems and compared those with versus those without LAA isolation (LAAI). Methods Between 08/2021 and 10/2022 we enrolled 83 consecutive patients (median age 73.2 years; median CHA2DS2-VASc Score 3.0; 51 men [61%]) of whom 59 (71%) had LAAI and 24 (29%) no LAAI. All patients had a least one previous catheter ablation procedure of AF. LAAO was done 6 weeks after the last ablation procedure. The main indication for LAAO was the implementation of electrical LAAI. In the no-LAAI group, all patients had lost persistent LAAI. Implanted devices were Watchman FLXTM (n=30) and LAmbreTM (n=53). Pertinent procedural data, periprocedural complications, as well as peri-device leaks (PDL) at 45 days were assessed according to device type. The composite endpoints (death, TIA/stroke, device thrombus, bleeding) and the clinical impact after switch of anticoagulation therapy were assessed at 12 months follow-up. Results The distribution of LAAI/No LAAI were found in 21[70%]/9 patients treated with the Watchman device and in 38[72%]/15 patients treated with the LAmbre device (p=0.87). PDL on follow-up (f/u) TEE was observed in 13/54 LAAI patients (24%) and 10/23 No-LAAI patients (43%, p=0.089). Leak distribution (&amp;lt;3mm/3-5mm/&amp;gt;5mm/no leak) at f/u was different between LAAI groups (LAAI: 12/1/0/41; No LAAI: 5/4/1/13; p=0.027) but not between device types. The mechanisms of leaks according to device type are listed in Table 1. Procedural complications were observed in 6/59 LAAI patients and 0/24 No-LAAI patients (p=0.11). The composite endpoint of death, stroke, severe bleeding, device-related thrombus and thromboembolism was reached by a total of 2 patients (both LAAI with LAmbre device). In 9/13 LAAI-group patients (69%) with PDL (all &amp;lt;6 mm) the sealing effect was assumed to be incomplete with perfusion of the LAA. Post procedural anticoagulation therapy was switched after the control TEE from NOAC/VKA (8/1) to aspirin alone. None of these patients reached the composite endpoint after 12 months. Conclusions LAAO can be performed safely and efficaciously in patients with LAAI. Compared with patients without LAAI after LAAO, the occurrence of minor leaks, periprocedural complications, and composite endpoint events was not different between the two patient groups. Despite the presence of incomplete sealing with perfusion of LAA in the LAAI group, the switch in post-procedural anticoagulation seems to be safe regarding the composite endpoint after 12 months.Mechanism of PDL of the LAmbre DeviceMechanism of PDL between the LAAO types

Bioresorbable vascular scaffolds - a single center experience

Abstract Funding Acknowledgements None. Background/Introduction Bioresorbable vascular scaffolds (BVS) were considered promising alternatives to drug-eluting stents in percutaneous coronary interventions (PCI). They would restore the normal vasomotor tone and allow positive remodeling, reducing the trigger for inflammation and facilitating further interventions. Although randomized trials showed beneficial outcomes up to 1 year of follow-up, longer-term results have been disappointing, with increased rates of events, leading to its discontinuation. Purpose This study aims to evaluate our center’s 5-year follow-up of the BVS implantations, in terms of safety and efficacy. Methods Retrospective cohort of 46 patients submitted to PCI with a BVS was evaluated. The outcomes assessed were composite endpoint of death, myocardial infarction (MI), and revascularization (DMR), target vessel failure (TVF) and cardiovascular death, and each endpoint individually. Data analysis was done with SPSS software. Results The cohort was a total of 46 patients, with a mean age 69,5±1,5 years, and 23,9% women (n=11). The mean follow-up time was 5,6±0,2 years. BVS were implanted 74% (n=34) of the times in acute coronary syndromes, and 68% (n=31) were PCI on previous stent failure. Total of 24% (n=11) had an episode in the follow-up. Regarding each individual outcome, there was 9% (n=4) of MI, 0% (n=0) of cardiovascular deaths and 15,2% (n=7) of BVS re-stenosis requiring revascularization. Only 4% (n=2) of patients had complete BVS resorption on reassessment coronary angiography. Conclusions In the 5-year follow-up, there was a high rate of events, with 24% (n=11) of events, of which the most common was BVS re-stenosis, with 15,2% cases (n=7), and MI in 9% (n=4). Despite theoretical benefits with the resorption of BVS, it was only verified in 4% of the cases (n=2). According to the recent data, from the longer-term follow-up, BVS have been associated with a higher number of events, with the intended benefit not being verified.

Right Ventricular Function on Cardiovascular Magnetic Resonance Imaging and Long-Term Outcomes in Stable Heart Transplant Recipients.

In heart transplant recipients, right ventricular (RV) dysfunction may occur for a variety of reasons. Whether RV dysfunction in the stable phase after heart transplantation is associated with long-term adverse outcomes is unknown. We aimed to determine the long-term prognostic significance of RV dysfunction identified on cardiovascular magnetic resonance imaging (CMR) at least 1 year after heart transplantation. In consecutive heart transplant recipients who underwent CMR for surveillance, we assessed 2 CMR measures of RV function: RV ejection fraction and RV global longitudinal strain (RVGLS). We investigated associations between RV dysfunction and a composite end point of death or major adverse cardiac events, including retransplantation, nonfatal myocardial infarction, coronary revascularization, and heart failure hospitalization. A total of 257 heart transplant recipients (median age, 59 years; 75% men) who had CMR at a median of 4.3 years after heart transplantation were included. Over a median follow-up of 4.4 years after the CMR, 108 recipients experienced death or major adverse cardiac events. In a multivariable Cox regression analysis adjusted for age, time since transplantation, indication for transplantation, cardiac allograft vasculopathy, history of rejection, and CMR covariates, RV ejection fraction was not associated with the composite end point, but RVGLS was independently associated with the composite end point with a hazard ratio of 1.08 per 1% worsening in RVGLS ([95% CI, 1.00-1.17]; P=0.046). RVGLS provided incremental prognostic value over other variables in multivariable analyses. The association was replicated in subgroups of recipients with normal RV ejection fraction and recipients with late gadolinium enhancement imaging. A similar association was seen with a composite end point of cardiovascular death or major adverse cardiac events. CMR feature tracking-derived RVGLS assessed at least 1 year after heart transplantation was independently associated with the long-term risk of death or major adverse cardiac events. Future studies should investigate its role in guiding clinical decision-making in heart transplant recipients.

Transcatheter versus surgical aortic valve replacement for severe aortic valve stenosis: Meta-analysis with trial sequential analysis

ObjectivesRandomized controlled trials comparing transcatheter aortic valve implantation with surgical aortic valve replacement demonstrate conflicting evidence, particularly in low-risk patients. We aim to reevaluate the evidence using trial sequential analysis, balancing type I and II errors, and compare with conventional meta-analysis. MethodsDatabases were searched for randomized controlled trials, which were divided into higher-risk and lower-risk randomized controlled trials according to a pragmatic risk classification. Primary outcomes were death and a composite end point of death or disabling stroke assessed at 1 year and maximum follow-up. Conventional meta-analysis and trial sequential analysis were performed, and the required information size was calculated considering a type I error of 5% and a power of 90%. ResultsEight randomized controlled trials (n = 5274 higher-risk and 3661 lower-risk patients) were included. Higher-risk trials showed no significant reduction in death at 1 year with transcatheter aortic valve implantation (relative risk, 0.93, 95% CI, 0.81-1.08, P = .345). Lower-risk trials suggested lower death risk on conventional meta-analysis (relative risk, 0.67, 95% CI, 0.47-0.96, P = .031), but trial sequential analysis indicated potential spurious evidence (P = .116), necessitating more data for conclusive benefit (required information size = 5944 [59.8%]). For death or disabling stroke at 1 year, higher-risk trials lacked evidence (relative risk, 0.90, 95% CI, 0.79-1.02, P = .108). In lower-risk trials, transcatheter aortic valve implantation indicated lower risk in conventional meta-analysis (relative risk, 0.68, 95% CI, 0.50-0.93, P = .014), but trial sequential analysis suggested potential spurious evidence (P = .053), necessitating more data for conclusive benefit (required information size = 5122 [69.4%]). Follow-up results provided inconclusive evidence for both primary outcomes across risk categories. ConclusionsConventional meta-analysis methods may have prematurely declared an early reduction of negative outcomes after transcatheter aortic valve implantation when compared with surgical aortic valve replacement.

CT pericoronary adipose tissue density predicts coronary allograft vasculopathy and adverse clinical outcomes after cardiac transplantation.

To assess pericoronary adipose tissue (PCAT) density on Coronary Computed Tomography Angiography (CCTA) as a marker of inflammatory disease activity in coronary allograft vasculopathy (CAV). PCAT density, lesion volumes, and total vessel volume-to-myocardial mass ratio (V/M) were retrospectively measured in 126 CCTAs from 94 heart transplant patients (mean age 49 [SD 14.5] years, 40% female) who underwent imaging between 2010 to 2021; age and sex-matched controls; and patients with atherosclerosis. PCAT density was higher in transplant patients with CAV (n = 40; -73.0 HU [SD 9.3]) than without CAV (n = 86; -77.9 HU [SD 8.2]), and controls (n = 12; -86.2 HU [SD 5.4]), p < 0.01 for both. Unlike patients with atherosclerotic coronary artery disease (n = 32), CAV lesions were predominantly non-calcified, comprised of mostly fibrous or fibrofatty tissue. V/M was lower in patients with CAV than without (32.4 mm3/g [SD 9.7] vs. 41.4 mm3/g [SD 12.3], p < 0.0001). PCAT density and V/M improved the ability to predict CAV from AUC 0.75 to 0.85 when added to donor age and donor hypertension status (p < 0.0001). PCAT density above -66 HU was associated with a greater incidence of all-cause mortality (OR 18.0 [95%CI 3.25-99.6], p < 0.01) and the composite endpoint of death, CAV progression, acute rejection, and coronary revascularization (OR 7.47 [95%CI 1.8-31.6], p = 0.01) over 5.3 (SD 2.1) years. Heart transplant patients with CAV have higher PCAT density and lower V/M than those without. Increased PCAT density is associated with adverse clinical outcomes. These CCTA metrics could be useful for diagnosis and monitoring of CAV severity.

Prognostic impact and predictors of persistent renal dysfunction in acute kidney injury after percutaneous coronary intervention for acute myocardial infarction.

This study aimed to evaluate the prognostic impact and predictors of persistent renal dysfunction in acute kidney injury (AKI) after an emergency percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). A total of 877 patients who underwent emergency PCI for AMI were examined. AKI was defined as serum creatinine (SCr) ≥ 0.3mg/dL or ≥ 50% from baseline within 48h after PCI. Persistent AKI was defined as residual impairment of SCr ≥ 0.3mg/dL or ≥ 50% from baseline 1month after the procedure. The primary outcome was the composite endpoints of death, myocardial infarction, hospitalization for heart failure, stroke, and dialysis. AKI and persistent AKI were observed in 82 (9.4%) and 25 (2.9%) patients, respectively. Multivariate Cox proportional hazards analysis demonstrated that persistent AKI, but not transient AKI, was an independent predictor of primary outcome (hazard ratio, 4.99; 95% confidence interval, 2.30-10.8; P < 0.001). Age > 75years, left ventricular ejection fraction < 40%, a high maximum creatinine phosphokinase MB level, and bleeding after PCI were independently associated with persistent AKI. Persistent AKI was independently associated with worse clinical outcomes in patients who underwent emergency PCI for AMI. Advanced age, poor cardiac function, large myocardial necrosis, and bleeding were predictors of persistent AKI.

Practicality and Safety of Electrical Pulmonary Vein Isolation and Left Atrial Appendage Ligation in Lung Transplant Recipients With Pretransplant Atrial Fibrillation.

Lung transplant surgery creates surgical pulmonary vein isolation (PVI) as a routine part of the procedure. However, many patients with pretransplant atrial fibrillation continue to have atrial fibrillation at 1 y. We hypothesized that the addition of electrical PVI and left atrial appendage isolation/ligation (LAL) to the lung transplant procedure restores sinus rhythm at 1 y in patients with pretransplant atrial fibrillation. We retrospectively reviewed all adult lung transplant recipients at the University of California Los Angeles from April 2006 to August 2021. All patients with pretransplant atrial fibrillation underwent concomitant PVI/LAL and were compared with lung transplant recipients without preoperative atrial fibrillation. In-hospital outcomes; 1-y survival; and the incidence of stroke, cardiac readmissions, repeat ablations, and sinus rhythm (composite endpoint) were examined at 1 y for the PVI/LAL cohort. Sixty-one lung transplant recipients with pretransplant atrial fibrillation underwent concomitant PVI/LAL. No patient in the PVI/LAL cohort required cardiac-related readmission or catheter ablation for atrial fibrillation within 1 y of transplantation. Freedom from the composite endpoint of death, stroke, cardiac readmission, and repeat ablation for atrial fibrillation at 1 y was 85% (95% confidence interval, 73%-92%) for lung transplant recipients treated with PVI/LAL. The addition of PVI/LAI to the lung transplant operation in patients with pretransplant atrial fibrillation was safe and effective in maintaining sinus rhythm and baseline risk of stroke at 1 y.

Characterizing advanced heart failure risk and hemodynamic phenotypes using interpretable machine learning

BackgroundAlthough previous risk models exist for advanced heart failure with reduced ejection fraction (HFrEF), few integrate invasive hemodynamics or support missing data. This study developed and validated a heart failure (HF) hemodynamic risk and phenotyping score for HFrEF, using Machine Learning (ML). MethodsPrior to modeling, patients in training and validation HF cohorts were assigned to 1 of 5 risk categories based on the composite endpoint of death, left ventricular assist device (LVAD) implantation or transplantation (DeLvTx), and rehospitalization in 6 months of follow-up using unsupervised clustering. The goal of our novel interpretable ML modeling approach, which is robust to missing data, was to predict this risk category (1, 2, 3, 4, or 5) using either invasive hemodynamics alone or a rich and inclusive feature set that included noninvasive hemodynamics (all features). The models were trained using the ESCAPE trial and validated using 4 advanced HF patient cohorts collected from previous trials, then compared with traditional ML models. Prediction accuracy for each of these 5 categories was determined separately for each risk category to generate 5 areas under the curve (AUCs, or C-statistics) for belonging to risk category 1, 2, 3, 4, or 5, respectively. ResultsAcross all outcomes, our models performed well for predicting the risk category for each patient. Accuracies of 5 separate models predicting a patient's risk category ranged from 0.896 +/- 0.074 to 0.969 +/- 0.081 for the invasive hemodynamics feature set and 0.858 +/- 0.067 to 0.997 +/- 0.070 for the all features feature set. ConclusionNovel interpretable ML models predicted risk categories with a high degree of accuracy. This approach offers a new paradigm for risk stratification that differs from prediction of a binary outcome. Prospective clinical evaluation of this approach is indicated to determine utility for selecting the best treatment approach for patients based on risk and prognosis.

Patient Characteristics and Outcomes Associated with Sentinel Protection Device Use in Patients with Aortic Valve Disease Undergoing TAVR in a "Real-World" Setting.

Transcatheter aortic valve replacement (TAVR) has become the dominant treatment for aortic valve disease. While TAVR safety has improved over time, concern remains over the occurrence of cerebrovascular accidents (CVA) secondary to device placement, which is associated with increased morbidity and mortality. The Sentinel Cerebral Protection System (CPS) was developed to reduce the risk of embolic strokes associated with debris produced during TAVR. Studies evaluating Sentinel CPS efficacy have produced conflicting results, and there is little understanding of which patients are selected for device placement in "real-world" settings. With no existing guidelines on device use, the purpose of this study was to describe and compare the characteristics of patients who receive CPS with those who do not in a "real-world" setting of consecutive TAVR patients and evaluate its impact on postoperative complications, namely stroke. This was a single-center, retrospective study of all patients undergoing TAVR between July 1, 2019, and December 31, 2020. Patient demographics, baseline, and perioperative characteristics were collected prospectively using the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry and our institution's TAVR database for analysis. Postoperative outcomes were assessed using primary endpoints of in-hospital/30-day stroke and the composite of death, stroke, and bleeding/vascular events at one-year. To adjust for baseline differences, a propensity score was developed including all factors that were different between groups, and Multivariate Cox Regression analysis was used to control for these differences. Patient follow-up was 97% complete at 12 months with 100% echocardiographic follow-up. A total of 242 consecutive patients (57.9% male) were analyzed, with a mean age of 79.9 9 years. Of these patients, 134 (55.4%) received the Sentinel CPS and 108 (44.6%) did not. Sentinel CPS patients were more likely to be male, not on dialysis, without prior CVA or pacemaker, had less severe chronic lung disease, and were lower operative risk compared to concurrent non-CPS patients. CPS patients were also found to have higher hemoglobin and albumin levels, lower creatinine, and were less likely to be on immunosuppressant therapy. The incidence of in-hospital/30-day stroke after TAVR did not differ between CPS and non-CPS patients (0.0% vs. 1.9%; p = 0.198). Unadjusted analyses at one-year showed a lower occurrence of the composite endpoint in CPS patients compared non-CPS patients (8.3% vs. 17.0%; p = 0.034). After adjustment, the hazard ratio (Adj HR) for the CPS group was no longer significantly associated with a lower composite endpoint (Adj HR = 0.609, 95% CI 0.244-1.523; p = 0.289). Both unadjusted (p = 0.233) and adjusted (p = 0.132) analyses showed no difference in the incidence of stroke at one-year. Our study demonstrates that in a "real-world" setting, the Sentinel CPS device is more likely to be used in healthier and less complex patients. In analyses adjusted for illness severity and patient complexity, CPS use did not have a significant effect on the incidence of in-hospital/30-day stroke or the composite endpoint of death, stroke, and bleeding/vascular events at one-year.