Long-Term Outcomes of Mechanical versus Bioprosthetic Aortic Valve Replacement in Patients Under 50 Years Old: Meta-Analysis of Reconstructed Time-to-Event Data.

To compare long-term outcomes of mechanical versus bioprosthetic aortic valve replacement (AVR) in patients under the age of 50, we performed a study-level meta-analysis with reconstructed time-to-event data including studies published by December of 2023. The primary outcome was overall survival. Secondary outcomes included reoperation, major bleeding, and stroke. Five studies met our inclusion criteria with a total of 4245 patients (2311 mechanical, 1934 bioprosthetic). All studies were observational and the mean age of groups across the studies ranged from 38.2 to 43.0 years. The median follow-up time was 11.4 years (IQR, 6.9-15.0). Bioprosthetic AVR was associated with reduced overall survival and higher risk of all-cause death (HR, 1.170 [95% CI, 1.002-1.364], P=0.046), increased risk of reoperation over time (HR, 2.581, [95% CI, 2.102-3.168], P<0.001), decreased risk of major bleeding (HR, 0.500, [95% CI, 0.367-0.682], P<0.001), and decreased risk of stroke (HR, 0.751, [95% CI, 0.565-0.998], P=0.049) compared to mechanical AVR in patients under 50. In conclusion, for patients under the age of 50, bioprosthetic AVR is associated with increased mortality and risk of reoperation compared to mechanical valves. On the other hand, mechanical AVR is associated with an increased risk of major bleeding events and stroke. These aspects should be carefully considered during the selection of valve type in this age group; however, we should keep in mind that the statistically significant differences in the risk of all-cause death and stroke might not be clinically relevant (due to marginal statistical significance).

Outcomes of complete removal versus conservative therapy in cardiac implantable electronic device infections - A systematic review and Meta-analysis.

BACKGROUND: Complete removal of cardiac implantable electronic devices (CIEDs) is recommended in patients with CIED infections, including both systemic and localized pocket infection. The aim of the study was to provide an up-to-date and comprehensive assessment of evidence relating to the effect of complete CIED extraction in patients with a CIED infection. METHODS: We performed a systematic review and meta-analysis of studies reporting short- and mid-term outcomes in patients who had a device infection or infective endocarditis (IE) and underwent complete removal of the cardiac device (generator and leads) compared to those who received conservative therapy (no removal, partial removal, local antibiotic infiltration or isolated antibiotic therapy). The primary outcome was reinfection/relapse. Secondary outcomes were short-term (30-day/in-hospital) and mid-term (mean follow-up: 43.0 months) mortality. Random effects model was performed. RESULTS: Thirty-two studies met the criteria for inclusion in the final analysis. Patients with complete CIED extraction (n = 905) exhibited a lower rate of relapse/re-infection compared to patients (n = 195) with a conservative treatment approach (n = 195, OR 0.02, 95%CI 0.01-0.06, p < 0.0001, mean-follow-up: 16.1 months). Additionally, these patients displayed a lower short- (OR 0.40, 95%CI 0.23-0.69, p = 0.01) and mid-term (OR 0.52, 95%CI 0.34-0.78, p = 0.002) mortality. CONCLUSIONS: The analysis indicates that patients with a CIED infection who undergo complete CIED extraction exhibit a lower rate of relapse/re-infection. Additionally, a lower short- and mid-term mortality is observed, although it is acknowledged that this outcome may be influenced by treatment allocation bias.

Cardiac Damage Staging Predicts Outcomes in Aortic Valve Stenosis After Aortic Valve Replacement: Meta-Analysis.

Background: The prognostic value of cardiac damage staging classification based on the extent of extravalvular damage has been proposed in moderate/severe aortic stenosis (AS). Objectives: The purpose of this study was to assess the association of cardiac damage staging with mortality across the spectrum of patients with AS following aortic surgical or transcatheter aortic valve replacement (AVR). Methods: We conducted a pooled meta-analysis of Kaplan-Meier-derived reconstructed time-to-event data from studies published through February 2023. Results: In total, 16 studies (n = 14,499) met our eligibility criteria and included 12,282 patients with symptomatic severe AS and 2,217 patients with asymptomatic severe/moderate AS. For patients with symptomatic severe AS, all-cause mortality was 24.0%, 27.7%, 38.0%, 56.3%, and 57.3% at 5 years in patients with cardiac damage stage 0, 1, 2, 3, and 4, respectively (stage 0 as reference; HR in stage 1: 1.30 [95% CI: 1.03-1.64]; P = 0.029; stage 2: 1.74 [95% CI: 1.41-2.16]; P < 0.001; stage 3: 2.92 [95% CI: 2.35-3.64]; P < 0.001, and stage 4: 3.51 [95% CI: 2.79-4.41]; P < 0.001). For patients with asymptomatic moderate/severe AS, all-cause mortality was 19.3%, 36.9%, 51.7%, and 67.8% at 8 years in patients with cardiac damage stage 0, 1, 2, and 3 to 4, respectively (HR in stage 1: 1.70 [95% CI: 1.21-2.38]; P = 0.002; stage 2: 2.20 [95% CI: 1.60-3.02]; P < 0.001; and stage 3 to 4: 3.90 [95% CI: 2.79-5.47]; P < 0.001). Conclusions: In patients undergoing AVR across the symptomatic and severity spectrum of AS, cardiac damage staging at baseline has important prognostic implications. This pooled meta-analysis in patients undergoing AVR suggests that staging of baseline cardiac damage could be considered for timing and selection of therapy in patients with moderate or severe AS to determine the need for earlier AVR or adjunctive pharmacotherapy to prevent irreversible cardiac damage and improve the long-term prognosis.

Long-term outcomes of total arch replacement with bilateral antegrade cerebral perfusion using the "arch first" approach.

OBJECTIVE: To report outcomes of total arch replacement (TAR) with hypothermic circulatory arrest and bilateral antegrade cerebral perfusion (bACP) using an "arch first" approach for acute Type A aortic dissection (ATAAD). The "arch first" approach involved revascularization of the aortic arch branch vessels with uninterrupted ACP, before lower body circulatory arrest, while the patient was cooling. METHODS: This was an observational study of aortic surgeries from 2010 to 2021. All patients who underwent TAR with bACP for ATAAD were included. Short-term and long-term outcomes were reported utilizing descriptive statistics and Kaplan-Meier survival estimation. RESULTS: A total of 215 patients were identified who underwent TAR + bACP for ATAAD. Age was 59.0 [49.0-67.0] years and 35.3% were female. 73 patients (34.0%) underwent a concomitant aortic root replacement, 188 (87.4%) had aortic cannulation, circulatory arrest time was 37.0 [26.0-52.0] minutes, and nadir temperature was 20.8 [19.4-22.5] degrees Celsius. 35 patients (16.3%) had operative mortality (STS definition), 17 (7.9%) had a new stroke, 79 (36.7%) had prolonged mechanical ventilation (>24 h), 35 (16.3%) had acute renal failure (by RIFLE criteria), and 128 (59.5%) had blood product transfusions. One-year survival was 77.1%, while 5-years survival was 67.1%. During follow-up, there were 23 (10.7%) reinterventions involving the descending thoracic aorta - either thoracic endovascular aortic repair or open thoracoabdominal aortic replacement. CONCLUSIONS: Among patients with ATAAD, short-term postoperative outcomes after TAR + bACP using the "arch first" approach are acceptable. Moreover, this operative strategy may furnish long-term durability, with a reasonably low reintervention rate and satisfactory overall survival.

Long-Term Outcomes of Tricuspid Valve Replacement With Mechanical Versus Tissue Valves: Meta-Analysis of Reconstructed Time-to-Event Data.

Tricuspid valve replacement (TVR) with mechanical versus tissue valves remains a controversial subject. To evaluate the long-term effects of types of valves on patient-relevant outcomes, we performed a systematic review with meta-analysis of reconstructed time-to-event data of studies published by March 15, 2024 (according to referred the Reporting Items for Systematic Reviews and Meta-analyses guidelines). A total of 21 studies met our eligibility criteria and included 7,166 patients (mechanical: 2,495 patients, 34.8%). Patients who underwent mechanical TVR had a lower risk of death than those who received a tissue valve (hazard ratio [HR] 0.77, 95% confidence interval [CI] 0.70 to 0.84, p <0.001). Mechanical TVR was associated with lifetime gain, as evidenced by the restricted mean survival time, which was 2.2 years longer in patients who underwent TVR with mechanical valves (12.4 vs 10.2 years, p <0.001). Our landmark analysis for reoperations revealed the following: from the time point 0 to 7 years, we found no difference in the risk of reoperation between mechanical and tissues valves (HR 0.98, 95% CI 0.60 to 1.61, p = 0.946); however, from the time point 7 years onward, we found that mechanical TVR had a lower risk of reoperation in the follow-up (HR 0.24, 95% CI 0.08 to 0.72, p = 0.001). The meta-regression analysis demonstrated a modulating effect of atrial fibrillation on the association between mechanical valves and mortality; the HRs for all-cause death tended to decrease in the presence of populations with a larger proportion of atrial fibrillation (p = 0.018). In conclusion, our results suggest that TVR with mechanical valves, whenever considered clinically reasonable and accepted by patients as an option, can offer a better long-term survival and lower risk of reoperation in the long run.

Overcoming prosthesis-patient mismatch with transcatheter aortic valve replacement.

For decades, surgeons have recognized the risk of prosthesis-patient mismatch (PPM) when treating aortic stenosis (AS) with surgical aortic valve replacement (SAVR). The concept of PPM-or placing a valve that is too small for the cardiac output requirements of the patient-has been associated with worse patient outcomes, including increased risk of death. Transcatheter aortic valve replacement (TAVR) has become the standard treatment for most patients with severe symptomatic AS and is associated with improved hemodynamics and lower risks of PPM. Larger surgical valves, stentless, and sutureless technology, and surgical aortic annulus enlargement (AAE) have been employed to avoid severe PPM. However, especially in the small aortic annulus (SAA), TAVR may provide a benefit. Understanding who is at risk for PPM requires preplanning, and cardiac-gated computed tomography (CT) imaging is the standard of care when considering TAVR. It should be standard for all patients with AS. Once SAA is identified, the risk of PPM can be calculated, and an informed decision made on whether to proceed with SAVR or TAVR. In the current TAVR era, younger patients are treated with TAVR driven by patient preference, but with little long-term data to support the practice. Selecting the best valve for the patient is a multifactorial decision often nuanced by anatomical considerations, hemodynamic and durability expectations, and decisions regarding lifetime management that may include placing a second valve. Although PPM may be only one of the factors to consider, the association with elevated mean gradients and worse outcomes certainly makes TAVR a good solution for many patients.

Central versus peripheral cannulation for acute type A aortic dissection: A meta-analysis of over 14,000 patients.

OBJECTIVE: The optimal cannulation strategy for patients with acute type A aortic dissections (ATAAD) is unclear. METHODS: A systematic search was performed to identify all studies comparing aortic and non-aortic cannulation in patients undergoing ATAAD repair. The primary endpoint was overall survival. The secondary endpoints were operative mortality, postoperative stroke, renal failure, renal replacement therapy, paraplegia, and mesenteric ischemia. Pooled meta-analyses with aggregated and reconstructed time-to-event data were performed. RESULTS: Twenty-three studies were included (aortic: 3904; non-aortic: 10,719). Ten-year overall survival was 61.1 â€‹% and 58.4 â€‹% for aortic and non-aortic cannulation, respectively (HR 1.07; 95 â€‹% CI 0.92-1.25; p â€‹= â€‹0.38). No statistically significant difference was observed for operative mortality (p â€‹= â€‹0.10), stroke (p â€‹= â€‹0.89), renal failure (p â€‹= â€‹0.83), or renal replacement therapy (p â€‹= â€‹0.77). CONCLUSION: Patients undergoing surgery for ATAAD can undergo aortic cannulation with similar outcomes to those who undergo non-aortic cannulation.

Is Stroke risk analysis (SRA) a reliable method for predicting atrial fibrillation? A systematic review.

INTRODUCTION: Atrial fibrillation is responsible for a considerable number of cases of cardioembolism, accounting for 17% to 30% of the etiologies of all strokes. The software known as Stroke Risk Analysis (SRA) detects patients at high risk of paroxysmal atrial fibrillation by analyzing a continuous electrocardiogram recorded over different periods of time. OBJECTIVES: This article aims to carry out a systematic review investigating the effectiveness of the SRA method in predicting the risk of stroke patients having paroxysmal atrial fibrillation as the cause of the event. METHODS: The methods correspond to the format of the International Prospective Register of Systematic Reviews Protocol, according to CRD Identification Code: CRD42021253974. A systematic search was carried out in BMJB, PubMed/MEDLINE, Science Direct and LILACS. Six cohort studies met the inclusion criteria, representing a total of 2,088 participants with stroke, and compared the detection of patients with paroxysmal atrial fibrillation on the continuous recording electrocardiogram with a time variation of 1 to 48h with the use of SRA. RESULTS: Studies have shown that SRA has a high negative predictive value (between 96 and 99.1%) and can contribute to the selection of patients at high risk of paroxysmal atrial fibrillation to be referred for implantable cardiac monitoring to continue the investigation. CONCLUSIONS: A sequential combination of SRA with implantable cardiac monitoring is a promising strategy for detecting undiagnosed paroxysmal atrial fibrillation. Thus, the SRA can act as a cost-effective pre-selection tool to identify patients at higher risk of having paroxysmal atrial fibrillation as a possible cause of stroke and who may benefit from implantable cardiac monitoring. However, the lack of randomized studies is a limitation that must be considered.

Late Outcomes After Transcatheter Aortic Valve Implantation with Balloon-Versus Self-Expandable Valves: Meta-Analysis of Reconstructed Time-To-Event Data.

Self-expanding valves (SEV) and balloon-expandable valves (BEV) for transcatheter aortic valve implantation (TAVI) have their own features. There is a growing interest in long-term outcomes with the adoption of lifetime management in younger patients. To evaluate late outcomes in TAVI with SEV versus BEV, we performed a study-level meta-analysis of reconstructed time-to-event data published by May 31, 2023. We found no statistically significant difference in all-cause death after TAVI with SEV versus BEV. Randomized controlled trials are warranted to validate our results.

Extracorporeal life support after surgical repair for acute type a aortic dissection: A systematic review and meta-analysis.

BACKGROUND: The use of extracorporeal life support (ECLS) in patients after surgical repair for acute type A aortic dissection (ATAAD) has not been well documented. METHODS: We performed a systematic review and meta-analysis to assess the outcomes of ECLS after surgery for ATAAD with data published by October 2023 in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) and the Meta-analysis of Observational Studies in Epidemiology (MOOSE) reporting guidelines. The protocol was registered in PROSPERO (CRD42023479955). RESULTS: Twelve observational studies met our eligibility criteria, including 280 patients. Mean age was 55.0 years and women represented 25.3% of the overall population. Although the mean preoperative left ventricle ejection fraction was 59.8%, 60.8% of patients developed left ventricle failure and 34.0% developed biventricular failure. Coronary involvement and malperfusion were found in 37.1% and 25.6%, respectively. Concomitant coronary bypass surgery was performed in 38.5% of patients. Regarding ECLS, retrograde flow (femoral) was present in 39.9% and central cannulation was present in 35.4%. In-hospital mortality was 62.8% and pooled estimate of successful weaning was 50.8%. Neurological complications, bleeding and renal failure were found in 25.9%, 38.7%, and 65.5%, respectively. CONCLUSION: ECLS after surgical repair for ATAAD remains associated with high rates of in-hospital death and complications, but it still represents a chance of survival in critical situations. ECLS remains a salvage attempt and surgeons should not try to avoid ECLS at all costs after repairing an ATAAD case.

Impact of Incomplete Revascularization on Long-term Survival Based on Revascularization Strategy.

BACKGROUND: This study investigated the impact of complete revascularization (CR) and incomplete revascularization (IR) on long-term survival in patients undergoing isolated coronary artery bypass grafting (CABG) using multiple arterial graft (MAGs) or a single artery with saphenous vein grafts (SAGs). METHODS: Between January 2006 and December 2020, 12,625 patients underwent CABG and were divided into 4 groups: MAG CR (n = 1066), MAG IR (n = 286), SAG CR (n = 8360), and SAG IR (n = 2913). Inverse probability of treatment weighting based on the generalized propensity score was used to minimize imbalance between the groups. RESULTS: In the weighted cohort, median follow-up time was 8.35 years (interquartile range, 5.01-11.6 years). MAG CR was associated with similar long-term survival compared with MAG IR (hazard ratio [HR], 0.79; 95% CI, 0.60-1.03; P = .084). SAG CR was associated with improved long-term survival compared with SAG IR (HR, 0.67; 95% CI, 0.52-0.84; P = .01). MAG CR was associated with better long-term survival compared with SAG CR (HR, 0.45; 95% CI, 0.35-0.57; P < .001). Moreover, MAG IR was protective compared with SAG IR (HR, 0.62; 95% CI, 0.45-0.85; P = .033). Additional analysis was performed comparing perfect CR vs imperfect CR vs IR in MAG and SAG patients, separately. In the weighted sample of MAG, there were no differences in the long-term survival between perfect CR, imperfect CR, and IR. However, in the weighted sample of the SAG cohort, SAG perfect CR was associated with improved survival compared with SAG imperfect CR (HR, 0.81; 95% CI, 0.0.72-0.92; P = .001). Whereas, SAG perfect and imperfect CR were both associated with improved survival compared with SAG IR (HR, 0.51; 95% CI, 0.0.35-0.87; P = .006 and HR, 0.72; 95% CI, 0.64-0.82; P < .001), respectively. CONCLUSIONS: MAG CR is associated with better survival compared with SAG CR. If IR is inevitable, patients with MAG IR had better long-term survival compared with patients receiving SAG IR. Moreover, similar long-term survival is observed whether perfect CR, imperfect CR, or IR is achieved in the MAG population but not in SAG patients.

Moderate Aortic Valve Stenosis Is Associated With Increased Mortality Rate and Lifetime Loss: Systematic Review and Meta-Analysis of Reconstructed Time-to-Event Data of 409 680 Patients.

BACKGROUND: The mortality risk attributable to moderate aortic stenosis (AS) remains incompletely characterized and has historically been underestimated. We aim to evaluate the association between moderate AS and all-cause death, comparing it with no/mild AS (in a general referral population and in patients with heart failure with reduced ejection fraction). METHODS AND RESULTS: A systematic review and pooled meta-analysis of Kaplan-Meier-derived reconstructed time-to-event data of studies published by June 2023 was conducted to evaluate survival outcomes among patients with moderate AS in comparison with individuals with no/mild AS. Ten studies were included, encompassing a total of 409 680 patients (11 527 with moderate AS and 398 153 with no/mild AS). In the overall population, the 15-year overall survival rate was 23.3% (95% CI, 19.1%-28.3%) in patients with moderate AS and 58.9% (95% CI, 58.1%-59.7%) in patients with no/mild aortic stenosis (hazard ratio [HR], 2.55 [95% CI, 2.46-2.64]; P<0.001). In patients with heart failure with reduced ejection fraction, the 10-year overall survival rate was 15.5% (95% CI, 10.0%-24.0%) in patients with moderate AS and 37.3% (95% CI, 36.2%-38.5%) in patients with no/mild AS (HR, 1.83 [95% CI, 1.69-2.0]; P<0.001). In both populations (overall and heart failure with reduced ejection fraction), these differences correspond to significant lifetime loss associated with moderate AS during follow-up (4.4 years, P<0.001; and 1.9 years, P<0.001, respectively). A consistent pattern of elevated mortality rate associated with moderate AS in sensitivity analyses of matched studies was observed. CONCLUSIONS: Moderate AS was associated with higher risk of death and lifetime loss compared with patients with no/mild AS.

Acute Aortic Dissection After Transcatheter Aortic Valve Replacement.

Acute aortic dissection (AAD) is a rare and potentially fatal complication associated with transcatheter aortic valve replacement (TAVR). Owing to the paucity of existing institutional data, we sought to assess the incidence of postimplant AAD in patients who underwent TAVR at a single institution. All patients who underwent TAVR from 2013 to 2022 were retrospectively reviewed to identify those who possessed clinical or radiologic evidence of AAD after TAVR. Follow-up and survival data were retrieved for all included patients. A total of 4,317 patients underwent TAVR, of whom 9 (0.2%) sustained an AAD. These patients had a mean age of 80 years (range 53 to 92), mean Society of Thoracic Surgeons 30-day mortality risk of 5.7% (2.4% to 16.7%), and mean effective aortic valve area of 0.8 cm2 (0.4 to 1.5 cm2). Preoperative maximum aortic diameter was 3.9 cm (2.6 to 4 cm). Of these 9 patients, 6 (67%) showed evidence of Stanford type A dissection, whereas 3 (33%) were diagnosed with Stanford type B dissection. The most common causes of dissection were posterior annular rupture by the transcatheter valve (THV) (44%) and THV embolization or "pop-out" into the ascending aorta (22%). A total of 6 patients (66.7%), comprising 5 type A (55.6%) and 1 type B (11.1%) aortic dissections, died within 30 days of AAD. The median time to follow-up in those surviving TAVR with intraoperative AAD was 1,042 days (range: 648 to 2,666). Surviving patients were managed through thoracic endovascular aortic repair and medical management. In conclusion, in this highly selected cohort of patients, our experience indicates that AAD after TAVR is a rare but often lethal intraprocedural sequela of THV implantation, especially in cases of type A aortic dissection.

External validation of the ARCH score in patients undergoing aortic arch reconstruction under circulatory arrest.

BACKGROUND: Aortic arch surgery with hypothermic circulatory arrest (HCA) carries a higher risk of morbidity and mortality compared to routine cardiac surgical procedures. The newly developed ARCH (arch reconstruction under circulatory arrest with hypothermia) score has not been externally validated. We sought to externally validate this score in our local population. METHODS: All consecutive open aortic arch surgeries with HCA performed between 2014 and 2023 were included. Univariable and multivariable analyses were performed. Model discrimination was assessed by the C-statistic with 95% confidence intervals as part of the receiver operating characteristic (ROC) curve analysis. Model performance was visualized by a calibration plot and quantified by the Brier score. RESULTS: A total of 760 patients (38.3% females) were included. The mean age was 61 (±13.6) years, with 56.4% of patients' age >60 years. The procedures were carried out mostly emergently or urgently (59.6%). Total arch replacement was performed in 32.5% of the patients, and aortic root procedures were carried out in 74.6%. In-hospital death occurred in 64 patients (8.4%), and stroke occurred in 5.4%. The C-statistic revealed a low discriminatory ability for predicting in-hospital mortality (area under the ROC curve, 0.62; 95% confidence interval, 0.54-0.69; P = .002); however, model calibration was found to be excellent (Brier score of 0.07). CONCLUSIONS: The ARCH score for in-hospital mortality showed low discriminatory ability in our local population, although with excellent ability for prediction of mortality.

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 after 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 Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Outcomes included summary C-statistics and model risk of bias assessed with the Prediction Model Risk of Bias Assessment Tool. 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% confidence interval [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). CONCLUSIONS: 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.

Late Outcomes of Surgery Versus Medical Therapy in Patients With Type A Aortic Intramural Hematoma: Meta-Analysis of Reconstructed Time-to-Event Data.

The effect of an initial surgical approach (in comparison with initial medical therapy) in acute type A intramural hematoma remains insufficiently explored. We designed a pooled analysis of Kaplan-Meier-derived individual patient data from studies with follow-up for overall survival (all-cause death). Restricted mean survival time was calculated to evaluate lifetime gain or loss. The Risk of Bias in Non-Randomized Studies of Interventions tool (ROBINS-I) was used to assess risk of bias. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) was applied to assess certainty of evidence. Eight studies met our eligibility criteria, including a total of 654 patients (311 patients treated with surgery and 343 patients treated with medical therapy alone). All the studies were non-randomized and observational. The median follow-up was 4.6 years (interquartile range 1.0 to 7.7). Patients who underwent surgery had a significantly lower risk of mortality compared with patients receiving medical therapy alone (hazard ratio 0.51, 95% confidence interval 0.35 to 0.74, p <0.001). The restricted mean survival time was overall 1.1 years greater with surgery compared with medical therapy, and this difference was statistically significant (p <0.001), which means that surgery is associated with lifetime gain. The overall risk of bias (ROBINS-I) was considered moderate-to-serious and the certainty of evidence (GRADE) was deemed to be low. In conclusion, in the overall follow-up, surgery as the initial approach was associated with better late survival and lifetime gain in comparison with medical therapy alone in the setting of acute type A aortic intramural hematoma; however, high-quality randomized trials are warranted to establish the efficacy of the surgical strategy.

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

OBJECTIVES: Randomized 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. METHODS: Databases 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%. RESULTS: Eight 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. CONCLUSIONS: Conventional 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.

Impact of Prosthesis-Patient Mismatch After Surgical Aortic Valve Replacement: Systematic Review and Meta-Analysis of Reconstructed Time-to-Event Data of 122 989 Patients With 592 952 Patient-Years.

BACKGROUND: It remains controversial whether prosthesis-patient mismatch (PPM) impacts long-term outcomes after surgical aortic valve replacement. We aimed to evaluate the association of PPM with mortality, rehospitalizations, and aortic valve reinterventions. METHODS AND RESULTS: We performed a systematic review with meta-analysis of reconstructed time-to-event data of studies published by March 2023 (according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses). Sixty-five studies met our eligibility criteria and included 122 989 patients (any PPM: 68 332 patients, 55.6%). At 25 years of follow-up, the survival rates were 11.8% and 20.6% in patients with and without any PPM, respectively (hazard ratio [HR], 1.16 [95% CI, 1.13-1.18], P<0.001). At 20 years of follow-up, the survival rates were 19.5%, 12.1%, and 8.8% in patients with no, moderate, and severe PPM, respectively (moderate versus no PPM: HR, 1.09 [95% CI, 1.06-1.11], P<0.001; severe versus no PPM: HR, 1.29 [95% CI, 1.24-1.35], P<0.001). PPM was associated with higher risk of cardiac death, heart failure-related hospitalizations, and aortic valve reinterventions over time (P<0.001). Statistically significant associations between PPM and worse survival were observed regardless of valve type (bioprosthetic versus mechanical valves), contemporary PPM definitions unadjusted and adjusted for body mass index, and PPM quantification method (in vitro, in vivo, Doppler echocardiography). Our meta-regression analysis revealed that populations with more women tend to have higher HRs for all-cause death associated with PPM. CONCLUSIONS: The results of the present study suggest that any degree of PPM is associated with poorer long-term outcomes following surgical aortic valve replacement and provide support for implementation of preventive strategies to avoid PPM after surgical aortic valve replacement.

Conservative Versus Surgical Therapy in Patients With Infective Endocarditis and Surgical Indication-Meta-Analysis of Reconstructed Time-to-Event Data.

BACKGROUND: Infective endocarditis represents a life-threatening disease with high mortality rates. A fraction of patients receives exclusively conservative antibiotic treatment due to their comorbidities and high operative risk, despite fulfilling criteria for surgical therapy. The aim of the present study is to compare outcomes in patients with infective endocarditis and indication for surgical therapy in those who underwent or did not undergo valve surgery. METHODS AND RESULTS: Three databases were systematically assessed. A pooled analysis of Kaplan-Meier-derived reconstructed time-to-event data from studies with longer follow-up comparing conservative and surgical treatment was performed. A landmark analysis to further elucidate the effect of surgical intervention on mortality was carried out. Four studies with 3003 patients and median follow-up time of 7.6 months were included. Overall, patients with an indication for surgery who were surgically treated had a significantly lower risk of mortality compared with patients who received conservative treatment (hazard ratio [HR], 0.27 [95% CI, 0.24-0.31], P<0.001). The survival analysis in the first year showed superior survival for patients who underwent surgery when compared with those who did not at 1 month (87.6% versus 57.6%; HR, 0.31 [95% CI, 0.26-0.37], P<0.01), at 6 months (74.7% versus 34.6%) and at 12 months (73.3% versus 32.7%). CONCLUSIONS: Based on the findings of this study-level meta-analysis, patients with infective endocarditis and formal indication for surgical intervention who underwent surgery are associated with a lower risk of short- and long-term mortality when compared with conservative treatment.

The Surgical Treatment of Infective Endocarditis: A Comprehensive Review.

Infective endocarditis (IE) is a severe cardiac complication with high mortality rates, especially when surgical intervention is delayed or absent. This review addresses the expanding role of surgery in managing IE, focusing on the variation in surgical treatment rates, the impact of patient demographics, and the effectiveness of different surgical approaches. Despite varying global data, a notable increase in surgical interventions for IE is evident, with over 50% of patients undergoing surgery in tertiary centres. This review synthesizes information from focused literature searches up to July 2023, covering preoperative to postoperative considerations and surgical strategies for IE. Key preoperative concerns include accurate diagnosis, appropriate antimicrobial treatment, and the timing of surgery, which is particularly crucial for patients with heart failure or at risk of embolism. Surgical approaches vary based on valve involvement, with mitral valve repair showing promising outcomes compared to replacement. Aortic valve surgery, traditionally favouring replacement, now includes repair as a viable option. Emerging techniques such as sutureless valves and aortic homografts are explored, highlighting their potential advantages in specific IE cases. The review also delves into high-risk groups like intravenous drug users and the elderly, emphasizing the need for tailored surgical strategies. With an increasing number of patients presenting with prosthetic valve endocarditis and device-related IE, the review underscores the importance of comprehensive management strategies encompassing surgical and medical interventions. Overall, this review provides a comprehensive overview of current evidence in the surgical management of IE, highlighting the necessity of a multidisciplinary approach and ongoing research to optimize patient outcomes.