Mid-term Outcomes Of Patients Research Articles

Comparative Data of Procedural and Midterm Outcomes in Patients Who Underwent Percutaneous Left Atrial Appendage Closure Between the WATCHMAN FLX and WATCHMAN 2.5 Devices - Insight From the OCEAN-LAAC Registry.

Limited data are available regarding clinical outcomes after percutaneous left atrial appendage closure using WATCHMAN FLX (WM-FLX) and WATCHMAN-2.5 (WM2.5) devices in Asian patients.Methods and Results: Data of 1,464 consecutive patients (WM-FLX, n=909; WM2.5, n=555) were extracted from a Japanese multicenter registry, and clinical data were compared between the 2 groups. No in-hospital deaths, periprocedural stroke, or device embolization occurred. Procedural success was significantly higher in the WM-FLX than WM2.5 group (95.8% vs. 91.9%; P=0.002) owing to the lower incidence of periprocedural pericardial effusion (0.55% vs. 1.8%; P=0.021). No significant differences in all-cause death, postprocedural stroke, and device-related thrombus were observed between the 2 groups. However, the cumulative bleeding rate at 1 year was substantially lower in the WM-FLX group (7.8% vs. 16.4%; P<0.001). Landmark analysis of bleeding events highlighted lower bleeding rates in the WM-FLX than WM2.5 group within the first 6 months (6.4% vs. 14.8%; P<0.001), with comparable bleeding rates over the 6- to 12-month period (1.5% vs. 3.2%, respectively; P=0.065). This study demonstrated higher early safety and lower 1-year bleeding rates in the WM-FLX than WM2.5 group. The lower bleeding events with WM-FLX are likely due to multiple factors other than purely difference in devices, such as postprocedural drug regimen.

EARLY TO MID-TERM OUTCOMES OF THE CUSTOM-MADE 3D-PRINTED TRIFLANGE ACETABULAR COMPONENT (AMACE) IN COMPLEX REVISION HIP ARTHROPLASTY: LARGEST UK STUDY REPORTING THE COMBINED EXPERIENCE OF TWO TERTIARY REVISION CENTRES

Different techniques have been described to address massive bone loss of the acetabulum in revision hip surgery. aMace has gained popularity as it provides customization aiming to restore hip centre and provide good initial stability in cases of large non-contained defects. It takes into account quality of host bone. Its porous defect filling scaffold provides an excellent surface for osteointegration.Our aim was to assess the short and mid-term outcomes of patients who underwent revision surgery using aMace system.Ethical approval was obtained. A retrospective study included all patients who had aMace between June 2013 and October 2022 allowing for a minimum of 12-months follow-up. Patients’ demographics, indication, bone-loss severity, reconstruction details, re-operation, complications, mortality, pain and function were assessed.52 cases were performed by 13 surgeons with median 51 months follow-up. Median age was 72.7 years. 86.5% were female. Average BMI was 25.3. Average ASA grade was 3.65% were classified as Paprosky IIIB and 32% were IIIA.73% were found to have poor bone quality on CT. Main indication for aMace was massive bone loss/discontinuity secondary to aseptic loosening in 88.5%.77% underwent single-stage revision. 53.8% had 2 or more previous revisions. 71% underwent stem revision in the same setting. 77% received a dual mobility bearing.Re-operation rate was 5.7% for instability and femoral PPF. LLD was reported in 9.6%.Permanent Sciatic nerve palsy occurred in 3.8% of the cases.30-days mortality was 1.9%.Statistically significant post-op improvements in pain and mobility were reported (p&lt;0.001). None of the acetabular components have been revised.Our study shows satisfactory surgical outcomes with a relatively low complication rate and significant pain and mobility improvements in the early to mid-term stages.We recommend these costly cases to be done in highly specialist centres adopting MDT approach.

B-13 | Short and Mid-Term Outcomes of Patients Undergoing Arterial Duct Stenting in Duct Dependent Pulmonary Circulation

B-13 | Short and Mid-Term Outcomes of Patients Undergoing Arterial Duct Stenting in Duct Dependent Pulmonary Circulation

Outcomes of Patients Presenting with Non-ST Elevation Myocardial Infarction Undergoing Surgical Revascularization.

Non-ST-segment elevation myocardial infarction (NSTEMI) is a leading cause of emergency hospitalisation across Europe. This study evaluates the in-hospital and mid-term outcomes of patients undergoing coronary artery bypass grafting (CABG) following NSTEMI. A retrospective analysis of all cases undergoing isolated CABG following NSTEMI from September/2017 to September/2022 at our Centre. Patients were stratified according to in-hospital survival. Patient characteristics, operative details, and procedural complications were compared between those who survived and those who did not. Predictors of in-hospital and mid-term mortality were evaluated using logistic and Cox regression modelling. Kaplan Meier analysis was used to generate a survival curve for all alive patients at the time of discharge. Among 1011 patients (median age 64 [56 - 72] years, 852 [84.3%] male), 735 (72.7%) underwent urgent, 239 (23.6%) elective, and 37 (3.7%) emergency CABG. The in-hospital mortality was 1.5% (15/1011 patients). Those who died were more likely to be NYHA class III/IV, have LVEF <21%, severe renal impairment, peripheral vascular disease (PVD), or poor mobility. Emergency procedures, pre-operative ventilation, inotropic support, and intra-aortic balloon pump (IABP) use were also more prevalent among those who died. Logistic regression modelling revealed new postoperative stroke (OR:22.0; 95% CI:3.6-135.5; p=0.001), pre-operative IABP use (11.4; 2.4-53.7; p=0.002), new haemodialysis (9.6; 2.7-34.7; p<0.001), PVD (5.6; 1.6-20.0; p=0.008), and poor mobility (OR: 4.8; 95% CI: 1.3-18.2; p=0.022) as independent predictors of in-hospital mortality. In conclusion, new postoperative stroke, pre-operative IABP use, new haemodialysis, PVD and poor mobility are independent predictors of mortality in NSTEMI patients undergoing isolated CABG.

Isolated or Combined Ascending Aortic Replacement through a Partial Sternotomy: Early and Midterm Outcomes

Abstract Background We aimed to investigate the in-hospital and midterm outcomes of patients undergoing ascending aortic replacement (AAR) through a partial or a full sternotomy approach through a propensity matching analysis. Methods We retrospectively included all patients (n = 167) who underwent elective AAR in our institution between 2013 and 2020. The study population was divided into two groups according to the surgical access (40 patient in the partial sternotomy or “PS” group and 127 in the full sternotomy or “FS” group). Due to the significant differences between the groups, a propensity matching of 1:3 was applied. In-hospital complications, survival, and reoperation at follow-up were investigated. Results The PS group showed higher cross-clamp and cardiopulmonary bypass times than the FS group (94.2 vs. 83 minutes and 164.2 vs. 126.8 minutes, respectively). Moreover, the postoperative ventilation time was significantly higher in the PS group, but it did not affect the length of stay in the intensive care unit (ICU). The incidences of bleeding, stroke, and mortality were comparable between the two groups (11 vs. 3%, 3 vs. 6%, and 5 vs. 3%, respectively). After a median follow-up of 2 ± 1.98 years, the Kaplan–Meier analysis showed no significant differences between the two groups (log-rank, p = 0.17) in terms of survival. Conclusion The surgical ascending aorta replacement through a partial sternotomy is associated with longer operative times, but this does not affect the early as well as the long-term follow-up.

Branched and fenestrated endovascular aortic arch repair in patients with native proximal aortic landing zone

ObjectiveFenestrated and branched thoracic endovascular repair (f/bTEVAR) have been successfully applied in patients with diverse aortic arch pathologies. The aim of this study is to present the early and mid-term outcomes of patients with native proximal aortic landing (NPAL) managed with f/bTEVAR. MethodsA single-center retrospective analysis of patients with NPAL, managed with f/bTEVAR, between September 1, 2011, and June 30, 2022, was conducted. All patients were treated with custom-made devices (Cook Medical) with landing within Ishimaru zones 0 to 2. Primary outcomes were technical success, mortality, stroke, and retrograde type A dissection at 30 days. Follow-up outcomes were considered secondary. ResultsA total of 126 patients were included (69.8% males; mean age, 70.8 ± 4.2 years; 18.3% urgent). The main indications (60.4%) for repair were aortic arch (29.4%) and thoracoabdominal aortic aneurysms (31.0%). Seventy-two patients (57.1%) were managed with fTEVAR. Proximal landing in zone 0 and 1 was chosen in 97.6%. Technical success was 94.4%, and 30-day mortality was 11.9%. Strokes were diagnosed in 13.5% of patients and major strokes were identified in 7.9% cases. Retrograde type A dissection rate was 3.9%. The multivariate analysis confirmed landing in Ishimaru zone 0 as an independently related factor for stroke (P = .005), whereas stroke (P < .001), pericardial effusion (P < .001), and acute kidney injury (P < .001) were independently related to 30-day mortality. Mean follow-up was 17.5 ± 9.3 months. The estimated survival rate and the freedom from reintervention rate were 72.6% (standard error, 4.4%) and 46.4% (standard error, 6.0%) at 24-month follow-up, respectively. ConclusionsStroke rate after endovascular arch repair was alarming among patients with NPAL. Proximal landing to zone 0 was related to higher risk of stroke. Reinterventions were common within the 24-month follow-up.

(246) - Short to Mid-Term Outcomes in Patients Bridged to Recovery Using Impella 5.5

(246) - Short to Mid-Term Outcomes in Patients Bridged to Recovery Using Impella 5.5

A Multicenter Study of the Mid-term Outcomes of Patients with Uncomplicated Type B Aortic Dissection After Distal Porous Talos Stent-Graft Implantation

ObjectivesThe Talos stent-graft has extended length to improve aortic remodeling, and distal porous design to decrease the rate of spinal cord ischemia. This study retrospectively analyzed its mid-term outcomes for uncomplicated type B aortic dissection in a multicenter study. MethodsThe primary safety endpoint was 30-day major adverse events, including all-cause mortality, dissection-related mortality, conversion to open surgery, and device-related adverse events. The primary efficacy endpoint was treatment success at 12 months post-operation, defined as no technical failure or secondary dissection-related reintervention. The survival status of the patients was visualized using the Kaplan-Meier curve. Aortic growth was assessed at four levels, and spinal cord ischemia was evaluated at 12 months. Results113 patients participated with a mean age of 54.4 (11.1) years and 71.7% (81/113) were male. The 30-day mortality was 0.9% (1/113), no conversions to open surgery or device-related adverse events were recorded. The 12-month treatment success rate was 99.1% (112/113), with no dissection-related reinterventions. There was no spinal cord or visceral ischemia at 12 months. At a median of 34 months follow-up, 9 further deaths were recorded and the 3-year survival rate was 91.7%. The percentage of aortic growth was 1.8% (2/111) at the tracheal bifurcation, 3.6% (4/111) below the left atrium, 6.0% (5/83) above the celiac artery, and 12.1% (9/74) below the lower renal artery. The total thrombosis rate of the false lumen at the stented segment was 80.5% (91/113). ConclusionsThe results showed satisfactory results of Talos stent-graft in terms of safety and efficacy. More data are needed to confirm the long-term performance.

Repair of complex transposition of great arteries: What is the best technique to avoid outflow tract obstructions?

This study aimed to evaluate the short-/mid-term outcome of patients with complex dextro (d)-/levo (l)-transposition of the great arteries (TGA), ventricular septal defect and left ventricular outflow tract obstructions. A single-centre, retrospective review of all complex dextro-TGA (n = 85) and levo-TGA (n = 22) patients undergoing different surgeries [Arterial switch operation + left ventricular outflow tract obstruction-resection (ASO-R), half-turned truncal switch/Mair (HTTS), Nikaidoh and Rastelli] between May 1990 and September 2022 was performed. Groups were analysed using Kruskal-Wallis test with post hoc pairwise comparison and Kaplan-Meier time-to-event models. A total of 107 patients [ASO-R (n = 20), HTTS (n = 23), Nikaidoh (n = 21), Rastelli (n = 43)] were included, with a median age of 1.0 year (0.5-2.5) and surgical repair median follow-up was 3.8 years (0.3-10.5). Groups did not differ in respect to early postoperative complications/early mortality. Five-year overall survival curves were comparable: ASO-R 78.9% (53.2-91.5), HTTS 75.3% (46.8-89.9), Nikaidoh 85% (60.4-94.9) and Rastelli 83.9% (67.5-92.5), P = 0.9. Highest rates of right ventricular outflow tract (RVOT) reinterventions [33.3% and 32.6% (P = 0.04)] and reoperations [28.6% and 32.6% (P = 0.02)] occurred after Nikaidoh and Rastelli procedures. However, overall freedom from RVOT reinterventions and RVOT reoperations at 5 years did not differ statistically significantly between the groups (ASO-R, HTTS, Nikaidoh and Rastelli): 94.4% (66.6-99.2), 69.1% (25.4-90.5), 67.8% (34-86.9), 64.4% (44.6-78.7), P = 0.2, and 90.0% (65.6-97.4), 91% (50.8-98.7), 65.3% (32.0-85.3) and 67.0% (47.4-80.6), P = 0.3. Surgical repair of complex dextro-/levo-TGA can be performed with satisfying early/mid-term survival. RVOT reinterventions/reoperations were frequent, with highest rates after Nikaidoh and Rastelli procedures. Left ventricular outflow tract obstruction reoperations were rare with zero events after Nikaidoh and HTTS procedures.

Early and midterm outcomes of EVAR with 34 and 36 mm large endograft sizes: A single tertiary center study

Aim: Endovascular aneurysm repair (EVAR) has become a preferred method for accessing anatomically suitable abdominal aortic aneurysms in recent years. Advances in techniques and materials have led to the management of more challenging cases. Anatomical difficulties in the structure of the aneurysm neck can adversely affect the success of the procedure. In this study, we aimed to evaluate early and midterm outcomes in patients with wide-necked infrarenal abdominal aortic aneurysms treated with 34 mm or 36 mm EVAR endografts. Material and Methods: We evaluated infrarenal abdominal aortic aneurysms treated with 34 mm or 36 mm long EVAR allografts between January 2019 and January 2023 at Ankara Bilkent City Hospital Cardiovascular Surgery Clinic. We included and assessed patients with a neck diameter of 28 mm or greater using follow-up computed tomography angiography (CTA). We evaluated early and midterm morbidity and mortality as well as endovascular complications such as endoleak or migration. Results: A total of 58 patients with wide-neck infrarenal abdominal aortic aneurysms underwent 34 mm or 36 mm EVAR endograft deployment. There was no early mortality. The mean follow-up period was 21.7±6.4 months. Eight patients were found to have endoleaks—four had type 2 endoleaks, two had type 1b endoleaks, one had type 3 endoleak and one had type 1a endoleak. Except for type 2 endoleaks, all patients underwent endovascular reintervention. Conclusion: Our study demonstrated the successful application of 34 mm or 36 mm long endografts to patients with abdominal aortic aneurysms with a wide neck diameter. Regarding the midterm outcomes, standard EVAR procedures with large endografts are feasible and have successful outcomes.

Comparison of Early and Mid-Term Outcomes After Classic and Modified Morrow Septal Myectomy in Patients with Hypertrophic Obstructive Cardiomyopathy.

The aim of our study is to compare the early and mid-term outcomes of patients with hypertrophic obstructive cardiomyopathy who underwent classic and modified Morrow septal myectomy. Between 2014 and 2019, 48 patients (24 males; mean age 49.27±16.41 years) who underwent septal myectomy were evaluated. The patients were divided into two groups - those who underwent classic septal myectomy (n=28) and those who underwent modified septal myectomy (n=20). Mitral valve intervention was higher in the classic Morrow group than in the modified Morrow group, but there was no significant difference (P=0.42). Mortality was found to be lower in the modified Morrow group than in the classic Morrow group (P=0.01). In both groups, the mean immediate postoperative gradient was significantly higher than the mean of the 3rd and 12th postoperative months. The preoperative and postoperative gradient difference of the modified Morrow group was significantly higher than of the classic Morrow group (P<0.001). Classic Morrow and modified Morrow procedures are effective methods for reducing left ventricular outflow tract obstruction. The modified Morrow procedure was found to be superior to the classic Morrow procedure in terms of reducing the incidence of mitral valve intervention with the reduction of the left ventricular outflow tract gradient.

Short and mid-term outcomes of valve-sparing, aortic root reimplantation (David’s procedure)

BackgroundIn the current study, we aimed to report the short- and mid-term outcomes of patients undergoing valve-sparing aortic root reimplantation (VSARR) and our center’s experience with the procedure.MethodsForty patients with aortic root aneurysms underwent VSARR at our center from 2010 until 2022. We retrospectively reviewed the medical records of these patients and extracted the relevant data. After carefully examining the aortic valve, the surgeon decided to perform Bentall or David’s procedure during the operation.ResultsThe study population comprised 31 (77.5%) men and nine (22.5%) women, with a mean age of 55.35 ± 15.40. One patient developed hemodynamic instability post-surgery in the hospital and died from multi-organ failure. Another patient had severe AI in the intraoperative echocardiography, and aortic valve replacement with a prosthetic graft was performed during the same operation. In pre-operation echocardiography, 25 (62.5%) patients had severe, nine (22.5%) had moderate, and six (15%) had mild AI. In the in-hospital post-operation follow-up echo, AI was improved, and no patients had severe AI (P < 0.001). Only eight patients had moderate AI in post-one-year follow-up echo exams, while the rest had mild AI.ConclusionDavid’s procedure showed excellent mid-term results in our center, with only one in-hospital mortality.

Left atrial posterior wall isolation using pulsed-field ablation: procedural characteristics, safety, and mid-term outcomes.

Non-pulmonary vein (PV) ablation targets such as posterior wall isolation (PWI) have been tested in patients with persistent atrial fibrillation (AF). Pulsed-field ablation (PFA) offers a novel ablation technology possibly able to overcome the obstacles of incomplete PWI and concerns of damage to adjacent structures compared to thermal energy sources. Our aim was to assess procedural characteristics, safety, and mid-term outcomes of patients undergoing PWI using PFA in a clinical setting. Patients undergoing PFA-PVI with PWI were included. First-pass isolation was controlled using a multipolar mapping catheter. One hundred consecutive patients were included (median age 69 [IQR 63-75] years, 33 females (33%), left atrial size 43 [IQR 39-47] mm, paroxysmal AF 24%). Median procedure time was 66 (IQR 59-77) min, and fluoroscopy time was 11 (8-14) min. PWI using PFA was achieved in 100% of patients with a median of 19 applications (IQR 14-26). There were no major complications. Overall, in 15 patients (15%), recurrent AF/AT was noted during a median follow-up of 144 (94-279) days. PWI using PFA appears safe and results in high acute isolation rates and high arrhythmia survival during mid-term follow-up. Further randomized trials are essential and warranted.

Transposition versus interposition method in microvascular decompression for trigeminal neuralgia: midterm analysis of both techniques in a single-center study.

Operative interposition of material between the trigeminal nerve and offending artery for surgical treatment of drug-resistant trigeminal neuralgia (TGN), following the Jannetta method, has been proven to be the most successful invasive treatment. Reexplorations of patients with recurrence of TGN have revealed nerve root irritations and scarring due to interposed material. To prevent these complications, modifications of microvascular decompression (MVD) aim at transposing the vessel away from the trigeminal nerve, without attachment of additional material to the nerve root. Given that both techniques (interposition and transposition) have been performed in the authors' institution, they decided to analyze them for the short- and midterm outcomes. All patients who had undergone MVD for drug-resistant TGN in the authors' institution between 2008 and 2022 were analyzed retrospectively. Outcome at discharge and follow-up was evaluated using the Barrow Neurological Institute pain intensity score. Additionally, complications and pain recurrence were assessed. A total of 114 patients were operated on using transposition and 110 patients were treated using interposition. For transposition 102 patients were followed up for a median of 31.5 months, and for interposition 100 patients were followed up for a median of 95 months. At discharge 92.1% versus 94.5% of patients in the transposition and interposition groups, respectively, experienced a good outcome (Barrow Neurological Institute pain intensity scores I-III). At follow-up, 83.3% versus 85% of patients in the transposition and interposition groups, respectively, continued to demonstrate a good outcome. In 4.9% of patients in the transposition group and in 6% of patients in the interposition group, recurrence of pain occurred. Complications occurred in 24.6% of patients in the transposition and in 27.3% of those in the interposition group. The most frequent complications were facial hypesthesia (10.5% vs 11.8%, transposition vs interposition), followed by CSF leaks (2.6% vs 8.2%). Transposition for MVD is an elegant way of solving vessel-nerve conflicts at the cerebellopontine angle. Similar to interposition, transposition shows positive short- and midterm outcomes for patients experiencing drug-resistant TGN. However, the main objective of transposition, which is improved prevention of recurrence and reduction of complications at the trigeminal nerve, could not be confirmed in this study.

Minimally Invasive Trans-Axillary versus Full Sternotomy Mitral Valve Repair: A Propensity Score-Matched Analysis on Mid-Term Outcomes.

Background and Objectives: Minimally invasive cardiac surgery is an established approach for the treatment of heart valve pathologies and is associated with excellent technical and early postoperative outcomes. Data from medium- and long-term longitudinal evaluation of patients who underwent mitral valve repair (MVr) through transaxillary approach (TAxA) are still lacking. The aim of this study is to investigate mid-term results in patients who underwent TAxA MVr. Materials and Methods: Prospectively collected data of patients who underwent first-time MVr for MV regurgitation between 2017 and 2022, were reviewed. A total of 308 patients received TAxA, while in 220 cases, traditional full sternotomy (FS) was performed. Concomitant aortic and coronary artery bypass grafting (CABG) procedures, infective endocarditis or urgent operations were excluded. A propensity match (PS) analysis was used to overcome preoperative differences between the populations. Follow-up data were retrieved from outpatients' clinic, telephone calls and municipal administration records. Results: After PS-matching, two well-balanced cohorts of 171 patients were analysed. The overall 30-day mortality rate was 0.6% in both cohorts. No statistical difference in postoperative complications was reported. TAxA cohort experienced earlier postoperative extubation (p < 0.001) with a higher rate of extubation performed in the operating theatre (p < 0.001), shorter intensive care unit (ICU) stay (p < 0.001), and reduced hospitalization with 51% of patients discharged home (p < 0.001). Estimated survival at 5 years was 98.8% in TAxA vs. 93.6% in FS cohort (Log rank p = 0.15). The cumulative incidence of reoperation was 2.6% and 4.4% at 5 years, respectively, in TAxA and FS cohorts (Gray test p = 0.49). Conclusions: TAxA approach for MVr was associated with low rates of in-hospital mortality and major postoperative complications being furthermore associated with shorter mechanical ventilation time, shorter ICU stay and reduced hospitalization with a higher rate of patients able to be discharged home. At mid-term, TAxA was associated with excellent survival and low rate of MV reoperation.

One-year outcomes of patients undergoing percutaneous coronary intervention with the revived directional coronary atherectomy catheter: Insights from the J-PCI OUTCOME registry.

We sought to investigate the 1-year outcomes, including all-cause and cardiovascular mortality, major adverse cardiovascular events (MACEs), and major bleeding, of patients undergoing percutaneous coronary intervention (PCI)with or without the revived directional coronary atherectomy (DCA)catheter in a Japanese nationwide registry. Clinical data regarding the midterm outcomes of patients undergoing PCI with DCA are scarce in contemporary real-world practice. We analyzed the data of 74,764 patients who underwent PCI at 179 hospitals from January 2017 to December 2018. The baseline characteristics and 1-year outcomes of patients with stable coronary artery disease or unstable angina who underwent PCI with or without DCA were assessed. Overall, 431 patients (0.6%) underwent PCI with DCA. Patients in the DCA group were younger and predominantly male, with fewer comorbidities than patients in the non-DCA group. Stentless PCI with DCA following additional drug-coated balloon (DCB) angioplasty was the dominant strategy in the DCA group (43.6%). One-year outcomes, including all-cause mortality (1.2% in the DCA group vs. 2.5% in the non-DCA group, respectively, p = 0.075), cardiovascular death (0.9% vs. 1.0%, p = 0.69), MACEs (1.9% vs. 1.8%, p = 0.96), and nonfatal major bleeding requiring readmission (1.2% vs. 1.4%, p = 0.62), were comparable between the two groups. In the DCA group, 1-year outcomes were comparable, regardless of whether the stent or DCB was used. One-year clinical outcomes after PCI with DCA in patients with stable coronary artery disease or unstable angina are acceptable, regardless of stent use.

Abstract 12199: Mid-Term Survival of Low-Risk Patients Treated With Transcatheter versus Surgical Aortic Valve Replacement: Meta-Analysis of Reconstructed Time-to-Event Data

Background: We performed a meta-analysis of reconstructed time-to-event data from randomized controlled trials (RCTs) and propensity-score matched (PSM) studies comparing transcatheter versus surgical aortic valve replacement (TAVR versus SAVR) to evaluate mid-term outcomes in patients considered low risk for SAVR. Methods and Results: Study-level meta-analysis of Kaplan-Meier-derived time-to-event of RCTs and PSM studies published by December 31, 2022. Eight studies (3 RCTs; 5 PSM studies) met our eligibility criteria and included 5,444 patients (2,639 patients underwent TAVR and 2,805 patients underwent SAVR). TAVR showed a higher risk of all-cause mortality at 8 years of follow-up [hazard ratio (HR) 1.22, 95% confidence interval (CI) 1.03-1.43, P=0.018]. Up to 2 years of follow-up, TAVR was not inferior to SAVR (HR 1.08, 95%CI 0.89-1.31, P=0.448); however, we observed a statistically significant difference after 2 years with higher mortality with TAVR (HR 1.51; 95% CI 1.14-2.00; P=0.004). This difference was driven by PSM studies; our sensitivity analysis showed a statistically significant difference between TAVR and SAVR when we included only PSM studies (HR 1.41, 95%CI 1.16-1.72, P=0.001), but no statistically significant difference when we included only RCTs (HR 0.89, 95%CI 0.69-1.16, P=0.398). At 8 years of follow-up after the primary intervention, the treatment difference in restricted mean survival time (RMST) is statistically significant, resulting in a benefit of 187.2 days (95% CI, 85.1-289.2, P&lt;0.001) in the SAVR arm. Conclusion: In comparison with TAVR, SAVR appeared to be associated with improved survival beyond 2 years in low-risk patients. However, the survival benefit of SAVR was only observed in PSM studies and not in RCTs. The addition of data from ongoing RCTs as well as longer follow-up in previous RCTs will help to confirm if there is a difference in mid- and long-term survival between TAVR vs. SAVR in low-risk population.

Midterm Survival of Low-Risk Patients Treated With Transcatheter Versus Surgical Aortic Valve Replacement: Meta-Analysis of Reconstructed Time-to-Event Data.

Background We performed a meta-analysis of reconstructed time-to-event data from randomized controlled trials (RCTs) and propensity-score matched (PSM) studies comparing transcatheter versus surgical aortic valve replacement (TAVR versus SAVR) to evaluate midterm outcomes in patients considered low risk for SAVR. Methods and Results Study-level meta-analysis of reconstructed time-to-event data from Kaplan-Meier curves of RCTs and PSM studies published by December 31, 2022 was conducted. Eight studies (3 RCTs, 5 PSM studies) met our eligibility criteria and included 5444 patients; 2639 patients underwent TAVR, and 2805 patients underwent SAVR. TAVR showed a higher risk of all-cause mortality at 8 years of follow-up (hazard ratio [HR] 1.22, [95% CI, 1.03-1.43], P=0.018). Up to 2 years of follow-up, TAVR was not inferior to SAVR (HR, 1.08 [95% CI, 0.89-1.31], P=0.448); however, we observed a statistically significant difference after 2 years with higher mortality with TAVR (HR, 1.51 [95% CI, 1.14-2.00]; P=0.004). This difference was driven by PSM studies; our sensitivity analysis showed a statistically significant difference between TAVR and SAVR when we included only PSM studies (HR, 1.41 [95% CI, 1.16-1.72], P=0.001) but no statistically significant difference when we included only RCTs (HR, 0.89 [95% CI, 0.69-1.16], P=0.398). Conclusions In comparison with TAVR, SAVR appeared to be associated with improved survival beyond 2 years in low-risk patients. However, the survival benefit of SAVR was observed only in PSM studies and not in RCTs. The addition of data from ongoing RCTs as well as longer follow-up in previous RCTs will help to confirm if there is a difference in mid- and long-term survival between TAVR versus SAVR in the low-risk population.

Transanal minimally invasive surgery for benign and malignant rectal lesions: midterm outcomes from a tertiary center

BACKGROUND: Although transanal minimally invasive surgery (TAMIS) for rectal neoplasia has gained wide acceptance, the mid-term and long-term outcomes are not widely reported in the literature. OBJECTIVE: Describe the mid-term outcomes of patients who underwent TAMIS for benign and malignant rectal lesions in a single center. DESIGN: Retrospective cohort study SETTINGS: Tertiary referral center PATIENTS AND METHODS: Demographic, clinical, and oncological outcomes of patients who underwent TAMIS between January 2015 and December 2022 were prospectively collected. The indication for TAMIS was based on the National Comprehensive Cancer Network guidelines. The follow up for the cancer patients included clinical examination, tumor markers every 6 months and MRI rectum at the end of one year. In addition, colonoscopy and CT scan at years one and three and a final CT scan and colonoscopy at year five. MAIN OUTCOME MEASURES: Mid-term oncological and clinical outcome. RESULTS: Thirty elective TAMIS procedures included adenocarcinoma for 33.3% (n=10) of the patients, 20% (n=6) neuroendocrine tumor and the 40% (n=12) were adenomatous lesions. Negative resection margins were achieved in all malignant lesions. Perioperative complications occurred in 2 patients (6.6%), one patient had breaching into the peritoneal cavity, and postoperative hypotension occurred in another patient. The median follow-up time was 23 months (range: 5–72 months). Two patients with adenoma and positive margins developed recurrent adenoma (6.6%) and one patient with initial polypectomy biopsy of adenocarcinoma, had TAMIS with histopathology of adenoma and distant metastasis had developed. CONCLUSIONS: TAMIS for local excision of rectal neoplasia is a valid option with favorable mid-term outcomes provided there is adherence to careful selection criteria. LIMITATIONS: Retrospective nature and small number of the patients.

Improved functional, radiographic and patient-reported outcomes at midterm follow-up for shoulder arthroplasty patients 75 years and older

BackgroundCurrent discussion centers around the appropriateness of shoulder arthroplasty in elderly patients, and whether anatomic and reverse total shoulder arthroplasty yield acceptable results in this population. The purpose of this study was to examine midterm outcomes in patients 75 years and older who underwent either procedure. MethodsA retrospective review was performed on patients who underwent anatomic total shoulder arthroplasty (aTSA) or reverse total shoulder arthroplasty (rTSA) between 2000 and 2018. Inclusion criteria was patient age ≥75 years at time of surgery and ≥1 years postoperative follow-up. Primary outcomes were differences in Simple Shoulder Test (SST), American Shoulder and Elbow Surgeons (ASES) score, Visual Analog Scale (VAS) pain score, and range of motion. A secondary outcome was revision surgery. Results22 patients who underwent aTSA and 17 patients who underwent rTSA were included. Mean age at surgery was 79 and 80 in the aTSA and rTSA groups, respectively. Mean postoperative follow-up was 6.6 years across both cohorts. Anatomic TSA patients experienced improvements in VAS (7 preop vs. 1 postop; p < 0.001), ASES (16 vs. 75; p < 0.001), and SST (2 vs. 8; p < 0.001) scores. Reverse TSA patients also experienced improvements in VAS (7 vs. 1; p < 0.001), ASES (29 vs. 74; p < 0.001), and SST (1 vs. 7; p < 0.001) scores. Anatomic TSA patients experienced improved external rotation (17° vs. 53°; p < 0.001), forward elevation (108° vs. 155°; p < 0.001), and internal rotation (L5 vs. T10; p < 0.001). Reverse TSA patients experienced improved forward elevation (52° vs. 126°; p < 0.001). 21 aTSA patients (100%) and 16 rTSA patients (94%) experienced survival free from revision. 100% of aTSA and rTSA patients experienced survival free from loosening. ConclusionBoth aTSA and rTSA can be performed in the elderly population with acceptable midterm outcomes, suggesting that implant survival and patient satisfaction have the potential to endure through the end of life. Level of evidenceIV.