Alkhouli, Mohamad

Abstract Aims Transcatheter mitral valve replacement (TMVR) has become a feasible alternative to surgical mitral valve replacement (SMVR) in selected patients at high surgical risk. The risk of valve thrombosis following SMVR and TMVR, and the optimal antithrombotic therapy following these procedures, remains uncertain. We aimed to compare the incidence of bioprosthetic mitral valve thrombosis (bMVT) after SMVR and TMVR, and the incidence of bMVT between patients on different antithrombotic regimens. Methods and results A literature search of Medline, Embase, and Cochrane Library was performed between January 2000 and August 2024. Random-effects models were used to derive pooled estimates of the incidence of bMVT in the absence of prior or active endocarditis and valve thrombosis. A total of 47 studies (6170 patients, total follow-up 9541.8 patient-years) were eligible for inclusion. The overall incidence of bMVT was 5.05 [95% confidence interval (CI) 3.18–8.01, I2 = 82%] per 100-patient-years. Subclinical bMVT was more common than clinically significant bMVT: incidence 19.11 vs. 7.91 per 100-patient-years, adjusted incidence rate ratio (aIRR) 4.62 (95% CI 1.39–15.36), P = 0.012. bMVT was numerically more common after TMVR than SMVR, but the comparison was not statistically significant: incidence 7.03 vs. 0.58 per 100-patient-years, aIRR 2.19 (95% CI 0.72–6.72), P = 0.170. Patients on vitamin-K antagonists (VKA) had a lower incidence of bMVT than patients on direct oral anticoagulants (DOAC; incidence 5.72 vs. 17.08, aIRR 0.31, 95% CI 0.13–0.73, P = 0.007). Conclusions bMVT is not uncommon, with numerically higher incidence in transcatheter compared to surgical valves, but the comparison was not statistically significant. VKAs are associated with a lower incidence of bMVT compared to DOACs.

Background: The research on the outcomes of transcatheter aortic valve replacement with balloon-expandable valves (BEV) and self-expanding valves (SEV) are limited. Hypothesis: This study aims to compare the clinical and hemodynamic outcomes of BEV and SEV at short-term (30 days), mid-term (1 year), and long-term (>1 year) endpoints. Methods: PubMed, Embase, Scopus, and Cochrane Library databases were searched up to April 25, 2024, for randomized controlled trials (RCTs). Random-effect model (DerSimonian–Laird method) was used to pool the risk ratios (RR), mean differences (MD) and 95% confidence interval (CI) for binary and continuous outcomes, respectively. Results: A total of 11 RCTs comprising 4,325 patients (2,295 BEV, 2,030 SEV) were included. At short-term, the risk of cardiovascular (RR: 0.56, 95% CI: 0.36-0.87) and all-cause mortality (RR: 0.54, 95% CI: 0.35-0.81) were lower in the BEV group. However, no differences were noted between the two treatment modalities in longer follow-ups despite the lower risk of moderate to severe paravalvular leak (PVL) among BEV patients. The risk of stroke was comparable between two groups across all three follow-up endpoints, albeit a limited number of studies suggesting the BEV group showed a greater risk of clinical valve thrombosis in mid-term and long-term assessments. The need for permanent pacemaker implantation was lower in BEV arm in short-term (RR: 0.56, 95% CI: 0.37-0.87) and mid-term (RR: 0.78, 95% CI: 0.64-0.94). Yet, this difference was not observed in long-term follow-ups. Conversely, the SEV group had a larger effective orifice area with lower mean transvalvular pressure gradient from short-term (MD: 0.17, 95% CI: 0.07-0.26 and MD: 3.71, 95% CI: 2.64-4.78, respectively) to long-term (MD: 0.25, 95% CI: 0.17-0.32 and MD: 3.73, 95% CI: 3.19-4.27, respectively) periods. Conclusions: BEV is associated with reduced risk of clinical outcomes at short-term; however, most differences diminish in longer evaluations, except for moderate to severe PVL. Conversely, SEV is linked to better hemodynamic outcomes and a lower risk of clinical valve thrombosis across all follow-up durations.

Abstract Background The exclusion/occlusion of the left atrial appendage (LAA) is a treatment option for atrial fibrillation (AF) patients who are at high risk of stroke and high risk of bleeding. As the role of the LAA is not well understood or explored, this study aims to assess its role on flow dynamics in the left atrium. Methods Computational fluid dynamics (CFD) simulations were carried out for nine AF patients before and after LAA exclusion. The flow parameters investigated included the LA velocities, Time Averaged Wall Shear Stress (TAWSS), Oscillatory Shear Index (OSI), Relative Residence Time (RRT), and Pressure in the LA. Results This study shows that, on average, a decrease in TAWSS (1.82 ± 1.85 Pa to 1.27 ± 0.96 Pa, p < 0.05) and a slight increase in OSI (0.16 ± 0.10 to 0.17 ± 0.10, p < 0.05), RRT (1.87 ± 1.84 Pa −1 to 2.11 ± 1.78 Pa −1 , p < 0.05), and pressure (−19.2 ± 6.8 mmHg to −15.3 ± 8.3 mmHg, p < 0.05) were observed in the LA after the exclusion of the LAA, with a decrease in low‐magnitude velocities. Conclusion The exclusion of the LAA seems to be associated with changes in LA flow dynamics. Further studies are needed to elucidate the clinical implications of these changes.

Abstract Background A significant proportion of patients requiring mitral valve (MV) intervention have undergone prior coronary artery bypass grafting (CABG). Reoperative heart surgery is associated with increased risk. Aims To evaluate the utilization and outcomes of transcatheter vs. surgical MV interventions in patients with prior CABG. Methods We queried the Nationwide Readmission Database (2016–21) to identify adults with prior CABG hospitalized for transcatheter or surgical MV intervention. In-hospital outcomes were compared using multivariable regression and propensity-matching analyses. Readmissions were compared using Cox proportional hazards regression model. Results Of 305 625 weighted hospitalizations for MV intervention, 23 506 (7.7%) occurred in patients with prior CABG. From 2016Q1–2021Q4, the use of transcatheter MV interventions increased among patients with prior CABG (72 to 191 for repair and 6 to 45 for replacement per 100 000 hospitalizations, both ptrend &lt; 0.001). Compared with surgical MV repair and replacement, transcatheter MV repair and replacement were associated with similar in-hospital mortality (adjusted odds ratio [aOR] 0.44, 95% confidence interval [CI] 0.20–1.03 for repair; aOR 0.61, 95% CI 0.38–1.02 for replacement) and 180-day heart failure (HF) readmissions (adjusted hazard ratio [aHR] 1.56, 95% CI 0.85–2.87 for repair; aHR 1.15, 95% CI 0.63–2.09 for replacement) and lower stroke, acute kidney injury, permanent pacemaker placement, length of stay, and non-home discharges, respectively. Vascular complications were higher with transcatheter vs. surgical MV replacement. Conclusion Transcatheter MV interventions are increasingly used as the preferred modality of MV intervention in patients with prior CABG and are associated with similar in-hospital mortality and 180-day HF readmissions compared with surgical MV interventions.

Background: Data on racial/ethnic and sex disparities in the utilization and outcomes of tricuspid valve surgery (TVS) in the United States are scarce. The authors aimed to evaluate the impact of race/ethnicity and sex on the utilization and outcomes of TVS. Methods: The authors analyzed the National Inpatient Sample database from 2016 to 2020 to identify hospitalizations for TVS. Racial/ethnic and sex disparities in TVS outcomes were determined using logistic regression models. Results: Between 2016 and 2020, 19 395 hospitalizations for TVS were identified. The utilization rate (number of surgeries/100,000 hospitalizations) was lower in Black and Hispanic patients compared with White patients for surgical tricuspid valve repair (STVr) (331 versus 493 versus 634, P<0.01) and surgical tricuspid valve replacement (STVR) (312 versus 601 versus 728, P<0.01). Similarly, the utilization rate was lower for women compared with men for STVr (1021 versus 1364, P<0.01) and STVR (930 versus 1,316, P<0.01). Compared to White men undergoing TVS, all women had lower odds of acute kidney injury [adjusted odds ratio (aOR) 0.65, 95% CI 0.55–0.78] and higher odds of blood transfusion (aOR 1.30, 95% CI 1.07–1.59), and Black men had higher odds of blood transfusion (aOR 1.59, 95% CI 1.08–2.35). In-hospital mortality and other surgical complications were similar between all groups (all P>0.05). Conclusions: Significant racial/ethnic and sex disparities exist in the utilization of TVS in the United States. Further studies are needed to understand the reasons for these disparities and to identify effective strategies for their mitigation.

Abstract OBJECTIVES Low forced expiratory volume in 1 s (FEV1) and elevated N-terminal pro-B-type natriuretic peptide (NT-Pro-BNP) have been individually associated with poor outcomes after transcatheter aortic valve replacement (TAVR). We hypothesized a combination of the 2 would provide prognostic indication after TAVR. METHODS We categorized 871 patients who received TAVR from 2008 to 2018 into 4 groups according to baseline FEV1 (&lt;60% or ≥60% predicted) and NT-Pro-BNP (&lt;1601 or ≥1601 pg/ml): group A (n = 312, high FEV1, low NT-Pro-BNP), group B (n = 275, high FEV1, high NT-Pro-BNP), group C (n = 123 low FEV1, low NT-Pro-BNP) and group D (n = 161, low FEV1, high NT-Pro-BNP). The primary end point was survival at 1 and 5 years. RESULTS Patients in group A had more severe aortic stenosis and achieved the best long-term survival at 1 [93% (95% CI: 90–96)] and 5 [45.3% (95% CI: 35.4–58)] years. Low FEV1 and high NT-Pro-BNP (group D) patients had more severe symptoms, higher Society of Thoracic Surgeons predicted risk of operative mortality, lower ejection fraction and aortic valve gradient at baseline. Patients in group D had the worst survival at 1 [76% (95% CI: 69–83)] and 5 years [13.1% (95% CI: 7–25)], hazard ratio compared to group A: 2.29 (95% CI: 1.6–3.2, P &lt; 0.001) with 25.7% of patients in New York Heart Association class III–IV. Patients in groups B and C had intermediate outcomes. CONCLUSIONS The combination of FEV1 and NT-Pro-BNP stratifies patients into 4 groups with distinct risk profiles and clinical outcomes. Patients with low FEV1 and high NT-Pro-BNP have increased comorbidities, poor functional outcomes and decreased long-term survival after TAVR.

Abstract Background Pulmonary vein stenosis (PVS), which is often unrecognized, may arise from a variety of conditions resulting in major morbidity and mortality. In some patients, pharmacological therapy may help but more often in advance stages, mechanical treatment must be considered. Transcatheter approaches, both balloon angioplasty (BA) and stent implantation have been applied. While both may be effective, they continue to be limited by restenosis. Herein, we compare the outcomes following BA and stenting for PVS. Purpose PVS presents a challenge for both diagnosis and therapy, with BA and stenting being primarily limited by restenosis. Stenting is performed in most cases and is associated with improved patency rates. Historical comparisons of BA and stenting for PVS have yielded similar results. Our analysis incorporates more conventional studies (2010–2021) and provides a larger stent (N=361) versus BA (N=229) contemporary analysis of the current state of PV intervention practice. Methods From January 1, 2010 to August 2, 2021, studies, limited to English language and humans, were assessed in Ovid MEDLINE®, Ovid Embase, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus. Two independent reviewers screened articles including those in which balloon angioplasty or stenting was performed for pulmonary vein stenosis with reporting of restenosis outcomes and data was independently extracted. Systematic review was performed, and overall restenosis rates were reported across all included studies. Meta-analysis was then performed using RevMan 5.4 assessing rates of restenosis and restenosis requiring repeat intervention. Results Our systematic review yielded 34 studies reporting on BA and/or stenting for PVS. Of these, 7 studies (1–7), treating a total of 343 patients with 590 PV interventions (229 BA and 361 Stents) reported restenosis rates with mean follow-up ranging from 10 to 60 months. Stenting was associated with a lower risk of restenosis compared to balloon angioplasty [risk ratio 0.35, 95% CI (0.18, 0.64), p=0.0008] (Figure 1). Restenosis requiring repeat intervention was reported in 5 studies, including 303 patients with 502 PV interventions (160 BA and 342 Stents) with stenting similarly associated with a lower risk of restenosis requiring re-intervention [risk ratio 0.34, 95% CI (0.16, 0.72), p=0.005]. Conclusion Stenting for pulmonary vein stenosis is associated with reduced risk of restenosis and re-intervention as compared to balloon angioplasty. Funding Acknowledgement Type of funding sources: None.

Importance In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited. Objective To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. Design, Setting, and Participants SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021. Intervention Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis. Main Outcomes and Measures The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years. Results A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P &amp;lt; .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm 2 vs 1.8 [0.6] cm 2 ; P &amp;lt; .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P &amp;lt; .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention. Conclusions and Relevance Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.