Machine-Learning Approaches for Risk Prediction in Transcatheter Aortic Valve Implantation: Systematic Review and Meta-Analysis.

OBJECTIVES: With the expanding integration of artificial intelligence (AI) and machine learning (ML) into the structural heart domain, numerous ML models have emerged for the prediction of adverse outcomes following transcatheter aortic valve implantation (TAVI). We aim to identify, describe, and critically appraise ML prediction models for adverse outcomes after TAVI. Key objectives consisted in summarizing model performance, evaluating adherence to reporting guidelines, and transparency. METHODS: We searched PubMed, SCOPUS, and Embase through August 2023. We selected published machine learning models predicting TAVI outcomes. Two reviewers independently screened articles, extracted data, and assessed the study quality according to the PRISMA guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). Outcomes included summary C-statistics and model risk of bias assessed with the Prediction Model Risk of Bias Assessment Tool (PROBAST). C-statistics were pooled using a random-effects model. RESULTS: Twenty-one studies (118,153 patients) employing various ML algorithms (76 models) were included in the systematic review. Predictive ability of models varied: 11.8% inadequate (C-statistic <0.60), 26.3% adequate (C-statistic 0.60-0.70), 31.6% acceptable (C-statistic 0.70-0.80), and 30.3% demonstrated excellent (C-statistic >0.80) performance. Meta-analyses revealed excellent predictive performance for early mortality (C-statistic: 0.81 [95% CI, 0.65-0.91]), acceptable performance for 1-year mortality (C-statistic: 0.76 [95% CI, 0.67-0.84]), and acceptable performance for predicting permanent pacemaker implantation (C-statistic: 0.75 [95% CI, 0.51-0.90]). CONCLUSION: ML models for TAVI outcomes exhibit adequate to excellent performance, suggesting potential clinical utility. We identified concerns in methodology and transparency, emphasizing the need for improved scientific reporting standards.

Catheter-based therapy for high-risk or intermediate-risk pulmonary embolism: death and re-hospitalization.

BACKGROUND AND AIMS: Catheter-based therapies (CBTs) have been developed as a treatment option in patients with pulmonary embolism (PE). There remains a paucity of data to inform decision-making in patients with intermediate-risk or high-risk PE. The aim of this study was to characterize in-hospital and readmission outcomes in patients with intermediate-risk or high-risk PE treated with vs. without CBT in a large retrospective registry. METHODS: Patients hospitalized with intermediate-risk or high-risk PE were identified using the 2017-20 National Readmission Database. In-hospital outcomes included death and bleeding and 30- and 90-day readmission outcomes including all-cause, venous thromboembolism (VTE)-related and bleeding-related readmissions. Inverse probability of treatment weighting (IPTW) was utilized to compare outcomes between CBT and no CBT. RESULTS: A total of 14 903 [2076 (13.9%) with CBT] and 42 829 [8824 (20.6%) with CBT] patients with high-risk and intermediate-risk PE were included, respectively. Prior to IPTW, patients with CBT were younger and less likely to have cancer and cardiac arrest, receive systemic thrombolysis, or be on mechanical ventilation. In the IPTW logistic regression model, CBT was associated with lower odds of in-hospital death in high-risk [odds ratio (OR) 0.83, 95% confidence interval (CI) 0.80-0.87] and intermediate-risk PE (OR 0.76, 95% CI 0.70-0.83). Patients with high-risk PE treated with CBT were associated with lower risk of 90-day all-cause [hazard ratio (HR) 0.77, 95% CI 0.71-0.83] and VTE (HR 0.46, 95% CI 0.34-0.63) readmission. Patients with intermediate-risk PE treated with CBT were associated with lower risk of 90-day all-cause (HR 0.75, 95% CI 0.72-0.79) and VTE (HR 0.66, 95% CI 0.57-0.76) readmission. CONCLUSIONS: Among patients with high-risk or intermediate-risk PE, CBT was associated with lower in-hospital death and 90-day readmission. Prospective, randomized trials are needed to confirm these findings.

Outcomes of Valve-in-Valve Transcatheter Aortic Valve Replacement.

Structural valve degeneration is increasingly seen given the higher rates of bioprosthetic heart valve use for surgical and transcatheter aortic valve replacement (TAVR). Valve-in-valve TAVR (VIV-TAVR) is an attractive alternate for patients who are otherwise at high risk for reoperative surgery. We compared patients who underwent VIV-TAVR and native valve TAVR through a retrospective analysis of our institutional transcatheter valve therapy (TVT) database from 2013 to 2022. Patients who underwent either a native valve TAVR or VIV-TAVR were included. VIV-TAVR was defined as TAVR in patients who underwent a previous surgical aortic valve replacement. Kaplan-Meier survival analysis was used to obtain survival estimates. A Cox proportional hazards regression model was used for the multivariable analysis of mortality. A total of 3,532 patients underwent TAVR, of whom 198 (5.6%) underwent VIV-TAVR. Patients in the VIV-TAVR cohort were younger than patients who underwent native valve TAVR (79.5 vs 84 years, p <0.001), with comparable number of women and a higher Society of Thoracic Surgeons risk score (6.28 vs 4.46, p <0.001). The VIV-TAVR cohort had a higher incidence of major vascular complications (2.5% vs 0.8%, p = 0.008) but lower incidence of permanent pacemaker placement (2.5% vs 8.1%, p = 0.004). The incidence of stroke was comparable between the groups (VIV-TAVR 2.5% vs native TAVR 2.4%, p = 0.911). The 30-day readmission rates (VIV-TAVR 7.1% vs native TAVR 9%, p = 0.348), as well as in-hospital (VIV-TAVR 2% vs native TAVR 1.4%, p = 0.46), and overall (VIV-TAVR 26.3% vs native TAVR 30.8%, p = 0.18) mortality at a follow-up of 1.8 years (0.83 to 3.5) were comparable between the groups. The survival estimates were also comparable between the groups (log-rank p = 0.27). On multivariable Cox regression analysis, VIV-TAVR was associated with decreased hazards of death (hazard ratio 0.68 [0.5 to 0.9], p = 0.02). In conclusion, VIV-TAVR is a feasible and safe strategy for high-risk patients with bioprosthetic valve failure. There may be potentially higher short-term morbidity with VIV-TAVR, with no overt impact on survival.

Readmission-related outcomes of surgical versus transcatheter aortic valve replacement in patients aged 65 or older with bicuspid aortic valve.

BACKGROUND: There continues to be debate regarding the superiority of transcatheter (TAVR) over surgical aortic valve replacement (SAVR) in patients with bicuspid aortic valves (BAV). We aimed to compare outcomes during readmissions in elderly patients with BAV who underwent SAVR or TAVR. METHODS: Patients 65 years or older with BAV who underwent TAVR or isolated SAVR were identified using the National Readmission Database from 2012 through 2018. We compared outcomes during readmissions within 90 days after discharge from the index surgery. Propensity score matching was performed to adjust the baseline differences. RESULTS: During the study period, 8555 and 1081 elderly patients with BAV underwent SAVR and TAVR, respectively. The number of patients who underwent TAVR went up by 179 % from 2012 to 2018. Propensity score matching yielded 573 patients in each group. A total of 111 (19.4 %) in the SAVR group and 125 (21.8 %) in the TAVR group were readmitted within 90 days after the index surgery (p = .31). The mortality during the readmissions within 90 days was equivalent between the two groups (0.9 % in the SAVR group vs. 3.2 % in the TAVR group, p = .22). However, the median hospital cost was approximately doubled in the TAVR group during the readmission (18,250 dollars vs. 9310 dollars in the SAVR group, p < .001). CONCLUSIONS: Readmission within 90 days was common in both groups. While the mortality during the readmissions after the surgery was equivalent between the two groups, hospital cost was significantly more expensive in the TAVR group.

Shock score for prediction of clinical outcomes among stable patients with acute symptomatic pulmonary embolism.

BACKGROUND: The Composite Pulmonary Embolism Shock (CPES) score has been developed to identify normotensive patients with acute pulmonary embolism (PE) and a low cardiac index (referred to as normotensive shock). We aimed to externally assess the validity of this model for predicting a complicated course among hemodynamically stable patients with acute PE. METHODS: Using prospectively collected data from the PROgnosTic valuE of Computed Tomography scan (PROTECT) study, we calculated the CPES score for each patient and the proportion of patients with a score > 3. We calculated the test performance characteristics to predict a complicated course (i.e., death from any cause, hemodynamic collapse, or recurrent PE) and the discriminatory power using the area under the receiver operating characteristic curve. RESULTS: Sixty-three of the 848 (7.4 %) patients had a complicated course during the 30-day follow-up period. Of the 848 enrolled patients, the CPES score was positive (i.e., score > 3) in 78 (9.2 %). The specificity was 92.1 % (723/785), the positive predictive value was 20.5 % (16/78), and the positive likelihood ratio was 3.22 for a complicated course. The areas under the receiver operating characteristic curve for a complicated course were 0.71 (95 % confidence interval [CI], 0.65-0.78). With the higher score risk classification threshold (cutoff score > 4), the proportion of patients designated as positive was 2.1 %, and the specificity was 98.1 %. When echocardiographic right ventricle (RV) dysfunction was replaced by computed tomographic RV enlargement, the specificity was 85.4 %, the positive predictive value was 14.2 %, and the positive likelihood ratio was 2.06 for a complicated course. When analyses were restricted to the subgroup of patients with intermediate-risk PE, the specificity and the positive predictive value for a complicated course were identical to the overall cohort. CONCLUSIONS: The CPES score has acceptable C-statistic, excellent specificity, and low positive predictive value for identification of hemodynamic deterioration in normotensive patients with PE. CLINICALTRIALS: gov number: NCT02238639.

Long-Term Outcomes of Valve-in-Valve Transcatheter Aortic Valve Implantation Versus Redo Surgical Aortic Valve Replacement: Meta-Analysis of Kaplan-Meier-Derived Data.

Valve-in-valve (ViV) transcatheter aortic valve implantation (ViV-TAVI) in patients with failed bioprostheses arose as an alternative to redo surgical aortic valve replacement (SAVR). To evaluate all-cause mortality in ViV-TAVI versus redo-SAVR, we performed a study-level meta-analysis of reconstructed time-to-event data from Kaplan-Meier curves of nonrandomized studies published by August 2023. A total of 16 studies met our eligibility criteria, with a total of 4,373 patients (2,204 patients underwent ViV-TAVI and 2,169 patients underwent redo-SAVR). Pooling all the studies, ViV-TAVI showed a lower risk of all-cause mortality in the first 6 months (hazard ratio [HR] 0.58, 95% confidence interval [CI] 0.46 to 0.73, p <0.001), with an HR reversal after this time point favoring redo-SAVR (HR 1.92, 95% CI 1.58 to 2.33, p <0.001). Pooling only the matched populations (which represented 64.6% of the overall population), ViV-TAVI showed a lower risk of all-cause mortality in the first 6 months (HR 0.56, 95% CI 0.43 to 0.73, p <0.001], with a reversal after 6 months favoring redo-SAVR (HR 1.55, 95% CI 1.25 to 1.93, p <0.001). The meta-regression analyses revealed a modulating effect of the following covariates: age, coronary artery disease, history of coronary artery bypass graft surgery, and implanted valves <25 mm. In conclusion, ViV-TAVI is associated with better survival immediately after the procedure than redo-SAVR; however, this primary advantage reverses over time, and redo-SAVR seems to offer better survival at a later stage. Because these results are pooled data from observational studies, they should be interpreted with caution, and randomized controlled trials are warranted.

Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study.

BACKGROUND: Hemodynamically unstable high-risk, or massive, pulmonary embolism (PE) has a reported in-hospital mortality of over 25%. Systemic thrombolysis is the guideline-recommended treatment despite limited evidence. The FLAME study (FlowTriever for Acute Massive PE) was designed to generate evidence for interventional treatments in high-risk PE. METHODS: The FLAME study was a prospective, multicenter, nonrandomized, parallel group, observational study of high-risk PE. Eligible patients were treated with FlowTriever mechanical thrombectomy (FlowTriever Arm) or with other contemporary therapies (Context Arm). The primary end point was an in-hospital composite of all-cause mortality, bailout to an alternate thrombus removal strategy, clinical deterioration, and major bleeding. This was compared in the FlowTriever Arm to a prespecified performance goal derived from a contemporary systematic review and meta-analysis. RESULTS: A total of 53 patients were enrolled in the FlowTriever Arm and 61 in the Context Arm. Context Arm patients were primarily treated with systemic thrombolysis (68.9%) or anticoagulation alone (23.0%). The primary end point was reached in 9/53 (17.0%) FlowTriever Arm patients, significantly lower than the 32.0% performance goal (P<0.01). The primary end point was reached in 39/61 (63.9%) Context Arm patients. In-hospital mortality occurred in 1/53 (1.9%) patients in the FlowTriever Arm and in 18/61 (29.5%) patients in the Context Arm. CONCLUSIONS: Among patients selected for mechanical thrombectomy with the FlowTriever System, a significantly lower associated rate of in-hospital adverse clinical outcomes was observed compared with a prespecified performance goal, primarily driven by low all-cause mortality of 1.9%. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04795167.

Randomized controlled trial of mechanical thrombectomy vs catheter-directed thrombolysis for acute hemodynamically stable pulmonary embolism: Rationale and design of the PEERLESS study.

BACKGROUND: The identification of hemodynamically stable pulmonary embolism (PE) patients who may benefit from advanced treatment beyond anticoagulation is unclear. However, when intervention is deemed necessary by the PE patient's care team, data to select the most advantageous interventional treatment option are lacking. Limiting factors include major bleeding risks with systemic and locally delivered thrombolytics and the overall lack of randomized controlled trial (RCT) data for interventional treatment strategies. Considering the expansion of the pulmonary embolism response team (PERT) model, corresponding rise in interventional treatment, and number of thrombolytic and nonthrombolytic catheter-directed devices coming to market, robust evidence is needed to identify the safest and most effective interventional option for patients. METHODS: The PEERLESS study (ClinicalTrials.gov identifier: NCT05111613) is a currently enrolling multinational RCT comparing large-bore mechanical thrombectomy (MT) with the FlowTriever System (Inari Medical, Irvine, CA) vs catheter-directed thrombolysis (CDT). A total of 550 hemodynamically stable PE patients with right ventricular (RV) dysfunction and additional clinical risk factors will undergo 1:1 randomization. Up to 150 additional patients with absolute thrombolytic contraindications may be enrolled into a nonrandomized MT cohort for separate analysis. The primary end point will be assessed at hospital discharge or 7 days post procedure, whichever is sooner, and is a composite of the following clinical outcomes constructed as a hierarchal win ratio: (1) all-cause mortality, (2) intracranial hemorrhage, (3) major bleeding, (4) clinical deterioration and/or escalation to bailout, and (5) intensive care unit admission and length of stay. The first 4 components of the win ratio will be adjudicated by a Clinical Events Committee, and all components will be assessed individually as secondary end points. Other key secondary end points include all-cause mortality and readmission within 30 days of procedure and device- and drug-related serious adverse events through the 30-day visit. IMPLICATIONS: PEERLESS is the first RCT to compare 2 different interventional treatment strategies for hemodynamically stable PE and results will inform strategy selection after the physician or PERT determines advanced therapy is warranted.

Self-Expanding Transcatheter Aortic Valves Optimize Transvalvular Hemodynamics Independent of Intra- Versus Supra-Annular Design.

This study sought to characterize transvalvular hemodynamics during the first 30 days after transcatheter aortic valve implantation (TAVI) across various transcatheter heart valves (THVs), while adjusting for annular dimensions. This was an observational study of TAVIs from September 2021 to October 2022. The primary outcome was mean transvalvular pressure gradient (TVPG), measured using transthoracic echocardiography at day 0, day 1, and day 30 post-TAVI, and were compared across 3 THV, including the self-expandable intra-annular Portico (Abbott Vascular, Santa Clara, California) valve, the balloon-expandable SAPIEN 3 Ultra (Edwards Lifesciences, Irvine, California), and the self-expandable supra-annular Evolut Pro+ (Medtronic, Minneapolis, Minnesota). A total of 560 patients who underwent TAVI were identified, of which 106 (18.9%) received a Portico THV, 176 (31.4%) received a SAPIEN THV, and 278 (49.6%) received an Evolut THV. For Portico THV, the TVPG on day 0 increased from 6.0 (4.7 to 9.0) to 7.0 (6.0 to 10.0) by day 30 (p = 0.009). For SAPIEN THV, the TVPG on day 0 increased from 6.5 (5.0 to 8.0) to 12.0 (9.0 to 15.0) by day 30 (p <0.001). For Evolut THV, the TVPG on day 0 increased from 6.0 (5.0 to 9.0) to 7.2 (5.0 to 10.0) by day 30 (p = 0.001). Adjusting for time and annular diameter in a multivariable mixed effects model, the SAPIEN group had a significantly greater increase in TVPG over time than the Evolut reference group (p <0.001), while there was no difference in the change of TVPG over time for the Portico group vs. the Evolut group (p = 0.874). In conclusion, compared with balloon-expandable valves, self-expanding THV may optimize transvalvular hemodynamics across all annular diameters, independent of their supra-annular and intra-annular design.

Thrombotic risk in patients with acute coronary syndromes discharged on prasugrel or clopidogrel: results from the PROMETHEUS study.

AIMS: Based on recent clinical data, the 2020 ESC guidelines on non-ST-elevation acute coronary syndrome (NSTE-ACS) suggest to tailor antithrombotic strategy on individual thrombotic risk. Nonetheless, prevalence and prognostic impact of the high thrombotic risk (HTR) criteria proposed are yet to be described. In this analysis from the PROMETHEUS registry, we assessed prevalence and prognostic impact of HTR, defined according to the 2020 ESC NSTE-ACS guidelines, and if the benefits associated with prasugrel vs. clopidogrel vary with thrombotic risk. METHODS AND RESULTS: PROMETHEUS was a multicentre prospective study comparing prasugrel vs. clopidogrel in ACS patients undergoing percutaneous coronary intervention (PCI). Patients were at HTR if presenting with one clinical plus one procedural risk feature. The primary endpoint was major adverse cardiac events (MACE), composite of death, myocardial infarction, stroke, or unplanned revascularization, at 1 year. Adjusted hazard ratio (adjHR) and 95% confidence intervals (CIs) were calculated with propensity score stratification and multivariable Cox regression. Among 16 065 patients, 4293 (26.7%) were at HTR and 11 772 (73.3%) at low-to-moderate thrombotic risk. The HTR conferred increased incidence of MACE (23.3 vs. 13.6%, HR 1.85, 95% CI 1.71-2.00, P < 0.001) and its single components. Prasugrel was prescribed in patients with less comorbidities and risk factors and was associated with reduced risk of MACE (HTR: adjHR 0.83, 95% CI 0.68-1.02; low-to-moderate risk: adjHR 0.75, 95% CI 0.64-0.88; pinteraction = 0.32). CONCLUSION: High thrombotic risk, as defined by the 2020 ESC NSTE-ACS guidelines, is highly prevalent among ACS patients undergoing PCI. The HTR definition had a strong prognostic impact, as it successfully identified patients at increased 1 year risk of ischaemic events.

Valve-in-valve transcatheter aortic valve replacement versus isolated redo surgical aortic valve replacement.

OBJECTIVE: To compare outcomes of patients undergoing valve-in-valve transcatheter aortic valve replacement (ViV TAVR) versus redo surgical aortic valve replacement (SAVR). METHODS: This was a retrospective study using institutional databases of transcatheter (2013-2022) and surgical (2011-2022) aortic valve replacements. Patients who underwent ViV TAVR were compared with patients who underwent redo isolated SAVR. Clinical and echocardiographic outcomes were analyzed. Kaplan-Meier survival estimation and Cox regression were performed. Cumulative incidence functions were generated for heart failure readmissions. RESULTS: A total of 4200 TAVRs and 2306 isolated SAVRs were performed. Of these, there were 198 patients who underwent ViV TAVR and 147 patients who underwent redo SAVR. Operative mortality was 2% in each group, but observed to expected operative mortality in the redo SAVR group was higher than in the ViV TAVR group (1.2 vs 0.32). Those who underwent redo SAVR were more likely to require transfusions and reoperation for bleeding, to have new-onset renal failure requiring dialysis, and to require a permanent pacemaker postoperatively than those in the ViV group. Mean gradient was significantly lower in the redo SAVR group than in the ViV group at 30 days and 1 year. Kaplan-Meier survival estimates at 1 year were comparable, and on multivariable Cox regression, ViV TAVR was not significantly associated with an increased hazard of death compared with redo SAVR (hazard ratio, 1.39; 95% CI, 0.65-2.99; P = .40). Competing-risk cumulative incidence estimates for heart-failure readmissions were higher in the ViV cohort. CONCLUSIONS: ViV TAVR and redo SAVR were associated with comparable mortality. Patients who underwent redo SAVR had lower postoperative mean gradients and greater freedom from heart failure readmissions, but they also had more postoperative complications than the VIV group, despite their lower baseline risk profiles.

Prevalence and Predictors of Cardiogenic Shock in Intermediate-Risk Pulmonary Embolism: Insights From the FLASH Registry.

BACKGROUND: Patients with acute pulmonary embolism (PE) and hypotension (high-risk PE) have high mortality. Cardiogenic shock can also occur in nonhypotensive or normotensive patients (intermediate-risk PE) but is less well characterized. OBJECTIVES: The authors sought to evaluate the prevalence and predictors of normotensive shock in intermediate-risk PE. METHODS: Intermediate-risk PE patients in the FLASH (FlowTriever All-Comer Registry for Patient Safety and Hemodynamics) registry undergoing mechanical thrombectomy with the FlowTriever System (Inari Medical) were included. The prevalence of normotensive shock (systolic blood pressure ≥90 mm Hg but cardiac index ≤2.2 L/min/m2) was assessed. A composite shock score consisting of markers of right ventricular function and ischemia (elevated troponin, elevated B-type natriuretic peptide, moderately/severely reduced right ventricular function), central thrombus burden (saddle PE), potential additional embolization (concomitant deep vein thrombosis), and cardiovascular compensation (tachycardia) was prespecified and assessed for its ability to identify normotensive shock patients. RESULTS: Over one-third of intermediate-risk PE patients in FLASH (131/384, 34.1%) were in normotensive shock. The normotensive shock prevalence was 0% in patients with a composite shock score of 0 and 58.3% in those with a score of 6 (highest score). A score of 6 was a significant predictor of normotensive shock (odds ratio: 5.84; 95% CI: 2.00-17.04). Patients showed significant on-table improvements in hemodynamics post-thrombectomy, including normalization of the cardiac index in 30.5% of normotensive shock patients. Right ventricular size, function, dyspnea, and quality of life significantly improved at the 30-day follow-up. CONCLUSIONS: Although hemodynamically stable, over one-third of intermediate-risk FLASH patients were in normotensive shock with a depressed cardiac index. A composite shock score effectively further risk stratified these patients. Mechanical thrombectomy improved hemodynamics and functional outcomes at the 30-day follow-up.

A Readmission Risk Score for Transcatheter Aortic Valve Replacement: An Analysis of 200,000 Patients.

OBJECTIVE: The objective of this study was to leverage a national database of TAVR procedures to create a risk model for 30-day readmissions. METHODS: The National Readmissions Database was reviewed for all TAVR procedures from 2011 to 2018. Previous ICD coding paradigms created comorbidity and complication variables from the index admission. Univariate analysis included any variables with a P-value of ≤0.2. A bootstrapped mixed-effects logistic regression was run using the hospital ID as a random effect variable. By bootstrapping, a more robust estimate of the variables' effect can be generated, reducing the risk of model overfitting. The odds ratio of variables with a P-value <0.1 was turned into a risk score following the Johnson scoring method. A mixed-effect logistic regression was run using the total risk score, and a calibration plot of the observed to expected readmission was generated. RESULTS: A total of 237,507 TAVRs were identified, with an in-hospital mortality of 2.2 %. A total of 17.4 % % of TAVR patients were readmitted within 30 days. The median age was 82 with 46 % of the population being women. The risk score values ranged from -3 to 37 corresponding to a predicted readmission risk between 4.6 % and 80.4 %, respectively. Discharge to a short-term facility and being a resident of the hospital state were the most significant predictors of readmission. The calibration plot shows good agreement between the observed and expected readmission rates with an underestimation at higher probabilities. CONCLUSION: The readmission risk model agrees with the observed readmissions throughout the study period. The most significant risk factors were being a resident of the hospital state and discharge to a short-term facility. This suggests that using this risk score in conjunction with enhanced post-operative care in these patients could reduce readmissions and associated hospital costs, improving outcomes.

Acute Coronary Syndrome After Transcatheter Aortic Valve Implantation (Results from Over 40,000 Patients).

Acute coronary syndrome (ACS) encompasses a broad category of presentations from unstable angina to ST-elevation myocardial infarctions. Most patients undergo coronary angiography upon presentation for diagnosis and treatment. However, the ACS management strategy after transcatheter aortic valve implantation (TAVI) may be complicated because of challenging coronary access. The National Readmission Database was reviewed to identify all patients who were readmitted with ACS within 90 days after TAVI between 2012 and 2018. Their outcomes were described between patients who were readmitted with ACS (ACS group) and without (non-ACS group). A total of 44,653 patients were readmitted within 90 days after TAVI. Among them, 1,416 patients (3.2%) were readmitted with ACS. The ACS group had a higher prevalence of men, diabetes, hypertension, congestive heart failure, peripheral vascular disease, and a history of percutaneous coronary intervention (PCI). In the ACS group, 101 patients (7.1%) developed cardiogenic shock, whereas 120 patients (8.5%) developed ventricular arrhythmias. Overall, 141 patients (9.9%) in the ACS group died during readmissions (vs 3.0% in the non-ACS group, p <0.001). Among the ACS group, PCI was performed in 33 (5.9%), whereas coronary bypass grafting was performed in 12 (0.82%). The factors associated with ACS readmission included a history of diabetes, congestive heart failure, chronic kidney disease, and PCI, and nonelective TAVI. Coronary artery bypass grafting was an independent factor related to in-hospital mortality during ACS readmission (odds ratio 11.9, 95% confidence interval 2.18 to 65.4, p = 0.004), whereas PCI was not (odds ratio 0.19, 95% confidence interval 0.03 to 1.44, p = 0.11). In conclusion, patients readmitted with ACS have significantly higher mortality compared with those readmitted without ACS. History of PCI is an independent factor associated with ACS after TAVI.

Outcomes of Transcatheter Aortic Valve Replacement in Patients With Concomitant Aortic Regurgitation.

BACKGROUND: This study sought to evaluate outcomes of transcatheter aortic valve replacement (TAVR) in patients with moderate or greater aortic regurgitation (AR). METHODS: This was an observational study using an institutional database of TAVRs from November 2012 to April 2022. The study compared outcomes of TAVR in patients with isolated aortic stenosis (AS) vs patients with AS and concomitant AR (moderate or greater). Those patients with trace or mild AR were excluded. Clinical and echocardiographic outcomes were compared, with end points established by the Valve Academic Research Consortium 3. Kaplan-Meier survival estimation and Cox regression for mortality were performed. Competing-risk cumulative incidence estimates for heart failure readmissions were also compared. RESULTS: Of 3295 patients, 605 (53.4%) had severe AS with no AR and 529 (46.6%) had severe AS with moderate or severe AR. There were no significant differences in in-hospital mortality, length of stay, stroke, myocardial infarction, permanent pacemaker requirement, transfusion requirement, minor or major vascular complications, or 30-day readmissions between the 2 groups (P > .05). There were also no significant differences in annular dissection or rupture, coronary obstruction, or device embolization. Mean gradient and paravalvular leak rates at 30 days and 1 year were similar between the groups. Survival estimates were comparable, and, on multivariable Cox regression, mixed aortic valvular disease was not associated with an increased hazard of death as compared with isolated AS (hazard ratio, 1.01; 95% CI, 0.81-1.25; P = .962). Cumulative incidence estimates for heart failure readmissions were comparable between groups. CONCLUSIONS: TAVR can be safely performed in patients with mixed valvular disease, with outcomes comparable to those in isolated AS.

Coronary Artery Bypass With Multiarterial Grafting vs Percutaneous Coronary Intervention.

BACKGROUND: Data comparing patients who undergo multiarterial grafting during coronary artery bypass grafting (CABG) vs percutaneous coronary intervention (PCI) in patients with multivessel coronary disease are scarce. This study addresses the relevance of using multiple arterial conduits vs PCI for appropriate patients. METHODS: This retrospective study included all patients with coronary artery disease who underwent CABG with multiple arterial conduits or PCI. Propensity score matching was performed for baseline characteristics. Kaplan-Meier estimates, cumulative incidence, and freedom from major adverse cardiac and cerebrovascular events (MACCE) curves were performed. RESULTS: The total patient population consisted of 3648 patients from 2011 to 2018 divided into 902 CABG patients and 2746 PCI patients. Patients were propensity matched (PCI, n = 838; CABG, n = 838). In the CABG cohort the left internal mammary artery was used in 837 patients (99.9%), the right internal mammary artery in 770 patients (92%), and radial arteries in 108 patients (12.9%). Patients in the PCI cohort had significantly higher 30-day mortality (24 [2.9%] vs 7 [0.8%], P < .01). Survival over follow-up (median, 4.9 years; range, 3.3-6.8) was better for the CABG cohort (730 [87.1%] vs 625 [74.6%], P < .01). Patients in the CABG cohort had greater freedom from MACCE (607 [72.4%] vs 339 [40.5%], P < .01). Cox multivariable regression showed that patients who underwent CABG had a significantly reduced risk of mortality (hazard ratio, 0.49; 95% confidence interval, 0.39-0.61; P < .01) and of MACCE (hazard ratio, 0.33; 95% confidence interval, 0.28-0.38; P < .01). CONCLUSIONS: Patients with coronary artery disease who undergo CABG with multiple arterial conduits have significantly fewer major adverse events, improved survival, and reduced hospital readmissions.

Acute outcomes for the full US cohort of the FLASH mechanical thrombectomy registry in pulmonary embolism.

BACKGROUND: Evidence supporting interventional pulmonary embolism (PE) treatment is needed. AIMS: We aimed to evaluate the acute safety and effectiveness of mechanical thrombectomy for intermediate- and high-risk PE in a large real-world population. METHODS: FLASH is a multicentre, prospective registry enrolling up to 1,000 US and European PE patients treated with mechanical thrombectomy using the FlowTriever System. The primary safety endpoint is a major adverse event composite including device-related death and major bleeding at 48 hours, and intraprocedural adverse events. Acute mortality and 48-hour outcomes are reported. Multivariate regression analysed characteristics associated with pulmonary artery pressure and dyspnoea improvement. RESULTS: Among 800 patients in the full US cohort, 76.7% had intermediate-high risk PE, 7.9% had high-risk PE, and 32.1% had thrombolytic contraindications. Major adverse events occurred in 1.8% of patients. All-cause mortality was 0.3% at 48-hour follow-up and 0.8% at 30-day follow-up, with no device-related deaths. Immediate haemodynamic improvements included a 7.6 mmHg mean drop in mean pulmonary artery pressure (-23.0%; p<0.0001) and a 0.3 L/min/m2 mean increase in cardiac index (18.9%; p<0.0001) in patients with depressed baseline values. Most patients (62.6%) had no overnight intensive care unit stay post-procedure. At 48 hours, the echocardiographic right ventricle/left ventricle ratio decreased from 1.23±0.36 to 0.98±0.31 (p<0.0001 for paired values) and patients with severe dyspnoea decreased from 66.5% to 15.6% (p<0.0001).  Conclusions: Mechanical thrombectomy with the FlowTriever System demonstrates a favourable safety profile, improvements in haemodynamics and functional outcomes, and low 30-day mortality for intermediate- and high-risk PE.

Readmission with infective endocarditis within 90 days following transcatheter aortic valve implantation.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) continues to be the most common modality of treating aortic stenosis in the United States. While infective endocarditis (IE) and its outcomes have been well documented after surgical aortic valve replacement, the incidence and outcomes of early IE after TAVI have not been well described. METHODS: All patients who underwent TAVI from 2012 through 2018 were identified using the National Readmission Database. Among them, patients who underwent TAVI at the index admission and readmitted within 90 days were included. Patients who died or had IE during the index admission were excluded. Clinical outcomes were compared between patients readmitted with IE (IE group) and those without (non-IE group). RESULTS: A total of 168,283 patients were readmitted to a hospital within 90 days after TAVI. The median age of the IE group and non-IE group were 81 and 82 years old, respectively (p = 0.21). Of those, 525 (0.3%) were readmitted with IE. The median time from TAVI to readmission was 20 days. During readmissions, 11.6% of the IE group died while only 3.15% of the non-IE group experienced death (p < 0.001). The most common causative organism of IE was enterococcus (22.1%). Multivariable analysis revealed that congestive heart failure, cerebrovascular disease, dialysis, concomitant valve disease, Medicaid, and discharge to a facility were independently associated with readmission with IE within 90 days. CONCLUSION: The incidence of readmission with IE is low after TAVI. However, the mortality was markedly high during readmissions. Surgical intervention was rarely performed for IE during the first admission. Enterococcus was the most common organism observed in IE after TAVI. DISCLOSURE: IS receives institutional research support from Abbott, Atricure, cryolife, and Medtronic. None related to this manuscript. CLINICAL TRIAL REGISTRATION: Not applicable.

Mechanical thrombectomy versus catheter directed thrombolysis in patients with pulmonary embolism: A multicenter experience.

OBJECTIVES: Compare in-hospital outcomes of patients treated with either mechanical thrombectomy (MT) or catheter directed lysis (CDL) in treatment of acute pulmonary embolism (PE). METHODS: This is a multicenter, retrospective cohort study of patients undergoing MT or CDL for acute PE between 2014 and 2021. The primary outcome was the composite of in-hospital death, significant bleed, vascular complication, or need for mechanical support post-procedure. Secondary outcomes included the individual components of the composite outcome in addition to blood transfusions, invasive hemodynamics, echocardiographic data, and intensive care unit (ICU) utilization. RESULTS: 458 patients were treated for PE with 266 patients in the CDL arm and 192 patients in the MT arm. The primary composite endpoint was not significantly different between the two groups with CDL 12% versus MT 11% (p = 0.5). There was a significant difference in total length of ICU time required with more in the CDL group versus MT (3.8 ± 2.0 vs. 2.8 ± 3.0 days, p = 0.009). All other secondary end points showed no significant difference between the groups. CONCLUSIONS: In patients undergoing catheter directed treatment of PE, there was no difference between MT and CDL in terms of in-hospital mortality, bleeds, catheter-related complications, and hemodynamics.

Development and validation of a scoring system for predicting clinical coronary artery perforation during percutaneous coronary intervention of chronic total occlusions: the PROGRESS-CTO perforation score.

BACKGROUND: Coronary artery perforation is a feared complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) and often leads to serious adverse clinical events. AIMS: We sought to develop a risk score to predict clinical coronary artery perforation in patients undergoing CTO PCI. METHODS: We analysed clinical and angiographic parameters from 9,618 CTO PCIs in the Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS-CTO). Logistic regression prediction modelling was used to identify variables independently associated with clinical perforation, and the model was internally validated with bootstrapping. Clinical coronary artery perforation was defined as any perforation requiring treatment. RESULTS: The incidence of clinical coronary perforation was 3.8% (n=367). Five factors were independently associated with perforation and were included in the score: patient age ≥65 years +1 point (odds ratio [OR] 1.79, 95% confidence interval [CI]: 1.37-2.33), moderate/severe calcification +1 point (OR 1.85, 95% CI: 1.41-2.42), blunt/no stump +1 point (OR 1.45, 95% CI: 1.10-1.92), use of antegrade dissection and re-entry +1 point (OR 2.43, 95% CI: 1.61-3.69), and use of the retrograde approach +2 points (OR 4.02, 95% CI: 2.95-5.46). The resulting score showed acceptable performance on receiver operating characteristic (ROC) curve (area under the curve [AUC]: 0.741, 95% CI: 0.712-0.773). The Hosmer-Lemeshow test indicated a good fit (p=0.991), and internal validation with bootstrapping demonstrated good agreement with the model with observed AUC: 0.736 (95% bias-corrected CI: 0.706-0.767). CONCLUSIONS: The PROGRESS-CTO perforation score may be a useful tool for predicting clinical coronary perforation during CTO PCI.