Risk Of Reintervention Research Articles

Abstract 17625: Comparative Analysis of Mortality and Amputation Rates in Patients Undergoing Atherectomy for Infra-Popliteal Peripheral Arterial Disease: Insight From the VQI

Introduction: Infra-popliteal peripheral arterial disease (IPPAD) poses challenges due to complex vasculature. The BASIL-2 trial demonstrated superiority in endovascular treatment compared with surgical bypass in patients with IPPAD. However, the choice of endovascular modality has not been conclusive. Hypothesis: Combining plain balloon angioplasty (POBA)+atherectomy is associated with improved clinical outcomes compared to POBA. Methods: Patients that underwent POBA vs POBA+Atherectomy for IPPAD from the Vascular Quality Initiative database were identified. Propensity score matching (PSM) was employed to balance the distribution of confounding variables for mortality identified on multivariable logistic regression. Patient characteristics and long-term outcomes between the two treatment groups were compared. Results: A total of 10,494 individuals (74.6%) were treated with POBA, while 3,569 (25.4%) were treated with POBA+atherectomy. PSM ensured minimal differences in baseline characteristics, such as indication for procedure and prior revascularization. The atherectomy group was associated with higher technical success and lower perioperative complications, such as renal complications and hematoma, at the expense of higher rates of distal embolization. During long term follow up, patients who underwent atherectomy had lower rates of major amputation but lower freedom from reintervention. There were no differences in major adverse limb events and mortality. Conclusion: Combining POBA with atherectomy appears to be a safe approach in IPPAD, with lower rates of long-term amputation at the cost of higher risk for future re-intervention.

Abstract 18989: Neonatal Arch Reconstruction via Sternotomy or Thoracotomy: A Propensity Score Matched Analysis

Introduction: For neonatal repair of coarctation of the aorta, patients may either undergo thoracotomy or sternotomy with cardiopulmonary bypass. While some guidance exists, the optimal approach remains poorly defined. Methods: This is a single center retrospective cohort study from 7/05 through 5/22 including patients who underwent neonatal aortic arch reconstruction for isolated coarctation of the aorta and excluding genetic syndromes, heterotaxy, and right aortic arch. Propensity score was estimated using demographic and anatomic variables and 1:1 optimal matching was performed. Primary outcomes were reintervention, either open or catheter-based, and survival. A hazard spline was constructed in order to assess the effect of varying distal arch size on hazard of reoperation (Figure 1). ICU and Hospital length of stay were secondary outcomes. Results: There were 263 patients who underwent isolated coarctation repair during the given time period. Matching yielded 50 patient pairs (n = 100). In the propensity matched population, one patient died and 11 patients underwent reintervention, with 2 of these patients undergoing 2 reinterventions. The interaction between distal transverse arch size and operative approach (sternotomy vs. thoracotomy) was statistically significant, p < 0.05 for interaction. Among patients with a distal arch z-score < -3.5, there appeared to be an advantage to sternotomy. With a distal arch z-score > -3.5, patients undergoing sternotomy appeared to have a disadvantage with respect to risk for reintervention. ICU length of stay was greater for patients undergoing sternotomy, 5.9 days [IQR: 4 to 12.6] vs 2.8 days [IQR: 1.7 to 4.2], p < 0.001, as was hospital length of stay, 14.3 days [IQR: 11 to 23.7] vs 6.5 days [IQR: 5.2 to 9.8], p < 0.001. Conclusions: Patients with a distal arch z-score larger than -3.5 may benefit from thoracotomy, and those with a distal arch z-score smaller than -3.5 may benefit from sternotomy.

Comparative Analysis of Mortality and Amputation Rates in Patients Undergoing Atherectomy for Infra-Popliteal Peripheral Arterial Disease: Insight From the VQI.

Infra-popliteal peripheral arterial disease (IPPAD) poses challenges due to high restenosis and occlusion rates. The BASIL-2 trial demonstrated the superiority of endovascular treatment compared with surgical bypass in patients with IPPAD. However, the association between different endovascular modalities and clinical outcomes has not been conclusive. Combining plain old balloon angioplasty (POBA) with atherectomy is associated with improved clinical outcomes compared with POBA alone. Patients who underwent POBA vs POBA+atherectomy for IPPAD from the Vascular Quality Initiative database were identified. To mitigate potential selection bias, we employed propensity score matching (PSM) to balance the distribution of confounding variables for mortality identified on multivariable logistic regression. Subsequently, we compared patient characteristics and long-term outcomes between the 2 treatment groups. Among patients who underwent endovascular intervention for IPPAD, 19 979 individuals (80.8%) were treated with POBA alone, while 4747 (19.2%) were treated with both POBA+atherectomy after PSM. Propensity score matching ensured minimal differences in baseline characteristics, such as indication for lower extremity revascularization (LER) and history of LER. After PSM, patients receiving POBA+atherectomy experienced higher rates of technical success and lower perioperative complications, such as renal complications and hematoma, compared with POBA alone. During long-term follow-up, patients who underwent atherectomy had lower rates of major amputation and major adverse limb events (MALE) but slightly lower freedom from reintervention. Nonetheless, there were no differences in mortality. Combining POBA with atherectomy appears to be a safe approach in patients with IPPAD, with lower rates of long-term amputation and MALE at the cost of a higher risk of reintervention. The use of adjunctive atherectomy is associated with improved long-term outcomes in patients with infra-popliteal disease.

Androgens and Urethral Health: How Hypogonadism Affects Postoperative Outcomes of Patients Undergoing Artificial Urinary Sphincter or Inflatable Penile Prosthesis Placement

To determine the role of androgens in penile and urethral health, we sought to understand what impact hypogonadism may have on artificial urinary sphincter (AUS) and inflatable penile prosthesis (IPP) outcomes. We hypothesize that patients with hypogonadism are at increased risk of reinterventions, complications, and infections. We queried the TriNetX Global Database in March 2023 for patients receiving an AUS or IPP, looking at lifetime reintervention, complication, and infection rates. We conducted multiple comparisons: (1) eugonadal patients against hypogonadal patients, (2) hypogonadal patients on testosterone replacement therapy (TRT) against hypogonadal patients not on TRT, and (3) hypogonadal patients on TRT against eugonadal patients. Hypogonadal patients undergoing AUS had more complications (33.5% vs 28.3%), higher reintervention rates (27.7% vs 24.3%) and higher infection rates (7.3% vs 6.8%), albeit none reaching significance. Hypogonadal patients undergoing IPP had significantly higher infection rates (6.3% vs 4.4%, RR 1.5 (1.04, 2.04)) and reintervention rates (14.9% vs 11.9%, RR 1.3 (1.04, 1.61)), but not complication rates (21.9% vs 18.9%). When comparing patients with hypogonadism on TRT vs off TRT, there was not a significant difference in reinterventions, or complications, in AUS and IPP patients, but there were significantly more infections in IPP patients (7.0% vs 3.9%, RR 1.9 (1.002, 3.5)). Hypogonadal patients have more reinterventions, complications, and infections following urologic implant surgery, to varying levels of significance. TRT may not be completely protective to improve tissue health but with many limitations that should be explored in further research.

Long-Term Risk of Reintervention after Uterine Preserving Surgical Fibroid Treatments and Variation by Sociodemographic Factors

Long-Term Risk of Reintervention after Uterine Preserving Surgical Fibroid Treatments and Variation by Sociodemographic Factors

Long-term risk of reintervention after transcatheter aortic valve replacement

Transcatheter aortic valve replacement (TAVR) has surpassed surgical aortic valve replacement (SAVR) as the predominant mode of valve replacement for the treatment of severe aortic stenosis (AS). However, the long-term need for valvular reintervention after TAVR remains unknown. Using data from the Medicare Fee for Service 100% dataset, all patients receiving TAVR between July 2011 and December 2020 were identified. Patients were categorized as receiving a valve reintervention (either surgical or transcatheter) or not using the appropriate International Classification of Diseases 10th Revision Procedure Coding System (ICD-10-PCS). A competing risk regression model was used to estimate the cumulative probability of valve reintervention. Of 230,644 TAVR patients were identified, of whom 1,880 received a reintervention. Patients receiving a reintervention were younger and more likely to be male. At 10 years, the crude rate of reintervention was 0.59% within a surviving cohort of 341 patients. After adjusting for the competing risk of death and other covariates, the adjusted cumulative incidence of reintervention at 10 years after TAVR was 1.63%. When the rate of reinterventions was compared between early (2011-2016) and later (2017-2020) time periods, the risk-adjusted rate of reintervention at 4 years had decreased over time (0.85% vs 0.51%). The 10-year risk of valve reintervention after TAVR is low and appears to be decreasing over time. Further research is necessary to determine the driving factors contributing to valve reintervention in the current era.

Percutaneous Transhepatic Biliary Drainage for Malignant Biliary Obstruction in Advanced Solid Organ Malignancy: Clinical Outcomes and a Perspective on Quality of Life

Background: Malignant obstructive jaundice is associated with a poor prognosis. Patients can undergo percutaneous transhepatic biliary drainage (PTBD), but the impact it has on quality of life is not well understood.Objective: To assess the potential impact of PTBD on quality of life in patients with obstructive jaundice from advanced malignancy using surrogate markers including complications, hospital length of stay, readmission, reintervention, and mortality. Methods: A retrospective analysis of a single-centre cohort of all patients with advanced solid organ malignancy undergoing PTBD between April 2020 and February 2022. Data was collected from electronic medical records.Results: Among the sixteen patients, abdominal pain and cholangitis were observed in 62.5% and 37.5% patients, respectively. Peritonitis, biliary leak, perihepatic abscess, and haemobilia occurred in individual cases. The median hospital length of stay post PTBD was nine days. The 30-day readmission rate for PTBD-related complications was 31.3% with a median of three total readmissions per patient. The 30-day reintervention rate was 62.5%. The 30-day all-cause mortality was 25% (95% CI:8.9-53.3), which included one procedure-related death. Conclusions: Quality of life in patients with obstructive jaundice from advanced solid organ malignancy undergoing PTBD can be adversely impacted due to the high risk of complications, reintervention, hospitalisation, and mortality. Thorough patient assessments are crucial in selecting appropriate candidates for PTBD.

Long-Term Outcomes of Open Versus Endovascular Treatment for Abdominal Aortic Aneurysm: Systematic Review and Meta-Analysis With Reconstructed Time-to-Event Data.

The advent of endovascular techniques has revolutionized the care of patients with uncomplicated abdominal aortic aneurysms. This analysis compares the overall survival and the freedom from reintervention rate between open surgical repair (OSR) and endovascular repair (EVAR) in patients undergoing elective abdominal aortic aneurysm (AAA) repair. PubMed, Scopus, and Cochrane databases were searched for studies including patients who underwent either OSR or EVAR for uncomplicated AAA. All randomized controlled trials and propensity-score-matched cohort studies reporting on the outcomes of interest were considered eligible for inclusion. The systematic search of the literature was performed by 2 independent investigators in accordance with the recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. We conducted 1-stage and 2-stage meta-analyses with Kaplan-Meier-derived time-to-event data and meta-analysis with a random-effects model. Thirteen studies met our eligibility criteria, incorporating 13 409 and 13 450 patients in the OSR and EVAR arms, respectively. Patients who underwent open repair had improved overall survival rates compared with those who underwent EVAR (hazard ratio [HR]=0.93, 95% confidence interval [CI]=0.88-0.98, p=0.004) during a mean follow-up of 53.8 (SD=29.8) months and this was validated by the 2-stage meta-analysis (HR=0.89, 95% CI=0.8-0.99, p=0.03, I2=62.25%). Splitting timepoint analysis suggested that EVAR offers better survival outcome compared with OSR in the first 11 months following elective intervention (HR=1.37, 95% CI=1.22-1.54, p<0.0001), while OSR offers a significant survival advantage after the 11-month timepoint and up to 180 months (HR=0.84, 95% CI=0.8-0.89, p<0.0001). Similarly, freedom from reintervention was found to be significantly better in EVAR patients (HR=1.28, 95% CI=1.14-1.44, p<0.0001) within the first 30 days. After the first month postrepair, however, OSR demonstrated higher freedom-from-reintervention rates compared with EVAR that remained significant for up to 168 months during follow-up (HR=0.73, 95% CI=0.66-0.79, p<0.0001). Despite the first-year survival advantage of EVAR in patients undergoing elective AAA repair, OSR was associated with a late survival benefit and decreased risk for reintervention in long-term follow-up. Open surgical repair for uncomplicated abdominal aortic aneurysm offers better long-term outcomes in terms of survival and freedom from reintervention rate compared to the endovascular approach but in the first year it carries a higher risk of mortality. The novelty of our study lies that instead of comparing study-level effect estimates, we analyzed reconstructed individual patient-level data. This offered us the opportunity to perform our analyses with mathematically robust and flexible survival models, which was proved to be crucial since there was evidence of different hazard over time. Our findings underline the need for additional investigation to clarify the significance of open surgical repair when compared to the latest endovascular devices and techniques within the evolving era of minimally invasive procedures.

Association Between Aneurysm Wall Inflammation Detected by Imaging Perivascular Fat and Secondary Intervention Risk for Abdominal Aortic Aneurysm Patients After Endovascular Repair.

To investigate the association between the imaging biomarker (volumetric perivascular characterization index [VPCI]) which indicates the aortic wall inflammation by mapping the spatial changes of perivascular fat attenuation on computed tomography angiography (CTA) and the reintervention risk for abdominal aortic aneurysm (AAA) patients after endovascular aortic repair (EVAR). This case-control study included AAA patients undergoing EVAR from a single center (n=260). Cases were AAA patients undergoing reintervention after EVAR and a 1:1 frequency-matched control group of AAA patients post-EVAR with a shrunken or ≥3-year stable sac and free of reintervention signs during the follow-up. The predictive variable (VPCI trajectory) was converted to binary variables according to the changing trend of VPCI with follow-up time. As a quasi-complete separation data pattern, least absolute shrinkage and selection operator (lasso) regression was used to screen and prove the VPCI trajectory as the best predictor, and the performance was evaluated by calculating the accuracy, sensitivity, and specificity. Between 2010 and 2021, 15 AAA patients after EVAR with type I/III endoleak, aneurysm rupture, or impending rupture were included. Compared with the 1:1 frequency-matched controls with a shrunken or ≥3-year stable sac and free of reintervention signs during the follow-up, VPCI trajectories of the case group were all upward trends, whereas the controls showed 86.7% downward trends (p<0.001). The best predictive model of lasso regressions included 4 variables, and VPCI trajectory was the most outstanding, followed by the proximal landing zone, the distal landing zone, and the infrarenal β angle. The accuracy, sensitivity, and specificity of predicting the risk of reintervention were as follows, respectively: 93.3%, 100%, and 86.7%. The wall inflammation detected by imaging perivascular adipose tissue based on the CTAs was strongly associated with the reintervention risk for AAA patients after EVAR, which might hold major promise as a new imaging biomarker for the mechanism and treatment study of human AAAs before and after EVAR. The study introduces a novel imaging biomarker which indicates the aortic wall inflammation by mapping spatial changes of perivascular fat attenuation on CTA. This biomarker demonstrates a strong association with the reintervention risk in AAA patients after EVAR. Incorporation of VPCI into clinical practice has the potential to enhance the traditional surveillance methods (CT/CTAs) by providing clinicians with a non-invasive method to assess aortic wall inflammation and predict the risk of reintervention. Additionally, this study might offer a valuable tool for mechanism and treatment research in humans with AAAs both pre- and post-EVAR, ultimately improving patient outcomes and refining therapeutic strategies.

Alfieri versus conventional repair for bileaflet mitral valve prolapse

ObjectiveMitral valve repair for bileaflet prolapse can be complex, involving multiple chords or resection. The Alfieri technique for bileaflet disease is simple but may be associated with mitral stenosis or recurrent mitral regurgitation. Outcomes of patients with bileaflet prolapse undergoing mitral valve repair using the Alfieri versus conventional chord/resection techniques were compared. MethodsAdults undergoing mitral valve repair for bileaflet prolapse for degenerative disease from 2017 to 2023 were stratified by repair technique. Outcomes including operative mortality and echocardiogram data were compared. Time to event analysis was used to characterize freedom from recurrent mitral regurgitation (moderate or greater mitral regurgitation). ResultsAmong 188 patients with bileaflet prolapse, 37% (70) were repaired with the Alfieri and the remaining patients were repaired with chords/resection. Compared with chords/resection, patients undergoing the Alfieri had shorter cardiopulmonary bypass and crossclamp times. Operative mortality (0% [0/70] vs 2% [2/118], P = .27) was similar between both techniques. The mean mitral gradient was low and similar for the Alfieri versus chords/resection (3 vs 3, P = .34). Development of recurrent mitral regurgitation at 2 years, incorporating the competing risk of death and mitral reintervention, was 4.3% (95% CI, 1.5%-9.3%) for the Alfieri technique and 5.8% (95% CI, 2.2%-11.8%) for chord/resection (P = .83). ConclusionsBoth the Alfieri and chord/resection techniques had low rates of recurrent mitral regurgitation at 2 years. The mitral valve gradient was low and similar regardless of technique; thus, those who received the Alfieri technique did not have an increased rate of mitral stenosis. The Alfieri may be an underused technique for bileaflet prolapse.

CardioCel® for repair of congenital heart defects: nationwide results of over 1000 implants.

To assess the mid-term performance of CardioCel for the repair of congenital heart defects. Data were retrospectively collected from databases and hospital records in 3 congenital cardiac surgery centres in Australia. Kaplan-Meier curves and log-rank tests were used to test for associations between patient age, gender, patch type and site of implantation. Multivariable Cox regression was used to test whether any specific implantation site was associated with reintervention risk, after adjusting for age group, gender and patch type. A total of 1184 CardioCel patches were implanted in 752 patients under the age of 18 years. Median age at implant was 12 months [interquartile range (IQR) 3.6-84]. Median follow-up was 2.1 years (IQR 0.6-4.6). Probability of freedom from CardioCel-related reintervention was 93% [95% confidence interval (CI) 91-95] at 1 year, 91% (95% CI 88-93) at 3 years and 88% (95% CI 85-91) at 5 years, respectively. On multivariable regression analysis, aortic valve repair had a higher incidence of reintervention [hazard ratio (HR) = 7.15, P = 0.008] compared to other sites. The probability of reintervention was higher in neonates (HR = 6.71, P = 0.0007), especially when used for augmentation of the pulmonary arteries (HR = 14.38, P = 0.029), as compared to other age groups. CardioCel can be used for the repair of a variety of congenital heart defects. In our study, in patients receiving a CardioCel implant, reinterventions were higher when CardioCel was used to augment the pulmonary arteries in neonates and for aortic valve repair as compared to other sites.

Bypass surgery versus endovascular revascularization for occlusive infrainguinal peripheral artery disease: a meta-analysis of randomized controlled trials for the development of the Italian Guidelines for the treatment of diabetic foot syndrome.

To report a review and meta-analysis of all randomized controlled trials (RCTs) comparing bypass surgery (BS) and endovascular treatment (ET) in infrainguinal peripheral arterial disease (PAD) for several endpoints, such as major and minor amputation, major adverse limb events (MALEs), ulcer healing, time to healing, and all-cause mortality to support the development of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome (DFS). A MEDLINE and EMBASE search was performed to identify RCTs, published since 1991 up to June 21, 2023, enrolling patients with lower limb ischemia due to atherosclerotic disease (Rutherford I-VI). Any surgical BS or ET was allowed, irrespective of the approach, route, or graft employed, from iliac to below-the-knee district. Primary endpoint was major amputation rate. Secondary endpoints were amputation-free survival major adverse limb events (MALEs), minor amputation rate, all-cause mortality, ulcer healing rate, time to healing, pain, transcutaneous oxygen pressure (TcPO2) or ankle-brachial index (ABI), quality of life, need for a new procedure, periprocedural serious adverse events (SAE; within 30days from the procedure), hospital lenght ofstay, and operative time. Twelve RCTs were included, one enrolled two separate cohorts of patients, and therefore, the studies included in the analyses were 13. Participants treated with ET had a similar rate of major amputations to participants treated with BS (MH-OR 0.85 [0.60, 1.20], p = 0.36); only one trial reported separately data on patients with diabetes (N = 1), showing no significant difference between ET and BS (MH-OR: 0.67 [0.09, 5.13], p = 0.70). For minor amputation, no between-group significant differences were reported: MH-OR for ET vs BS: 0.83 [0.21, 3.30], p = 0.80). No significant difference in amputation-free survival between the two treatment modalities was identified (MH-OR 0.94 [0.59, 1.49], p = 0.80); only one study reported subgroup analyses on diabetes, with a non-statistical trend toward reduction in favor of ET (MH-OR 0.62 [0.37, 1.04], p = 0.07). No significant difference between treatments was found for all-cause mortality (MH-OR for ET vs BS: 0.98 [0.80, 1.21], p = 0.88). A significantly higher rate of MALE was reported in participants treated with ET (MH-OR: 1.44 [1.05, 1.98], p = 0.03); in diabetes subgroup analysis showed no differences between-group for this outcome (MH-OR: 1.34 [0.76, 2.37], p = 0.30). Operative duration and length of hospital stay were significantly shorter for ET (WMD: - 101.53 [- 127.71, - 75.35] min, p < 0.001, and, - 4.15 [- 5.73, - 2.57] days, p < 0.001 =, respectively). ET was associated with a significantly lower risk of any SAE within 30days in comparison with BS (MH-OR: 0.60 [0.42, 0.86], p = 0.006). ET was associated with a significantly higher risk of reintervention (MH-OR: 1.57 [1.10, 2.24], p = 0.01). No significant between-group differences were reported for ulcer healing (MH-OR: 1.19 [0.53, 2.69], p = 0.67), although time to healing was shorter (- 1.00 [0.18, 1.82] months, p = 0.02) with BS. No differences were found in terms of quality of life and pain. ABI at the end of the study was reported by 7 studies showing a significant superiority of BS in comparison with ET (WMD: 0.09[0.02; 0.15] points, p = 0.01). The results of this meta-analysis showed no clear superiority of either ET or BS for the treatment of infrainguinal PAD also in diabetic patients. Further high-quality studies are needed, focusing on clinical outcomes, including pre-planned subgroup analyses on specific categories of patients, such as those with diabetes and detailing multidisciplinary team approach and structured follow-up.

Comparison of safety and healthcare utilization following sleeve gastrectomy or gastric bypass among medicare beneficiaries using sex as a biologic variable.

Bariatric surgery is a common operation, but differences in outcomes between males and females are unknown. To compare the risk of mortality, complications, reintervention, and healthcare utilization after sleeve gastrectomy or gastric bypass using sex as a biologic variable. United States. Retrospective cohort study of adults undergoing sleeve gastrectomy or gastric bypass from January 1, 2012 to December 31, 2018 using Medicare claims data. We performed a heterogeneity of treatment effect analysis to determine the impact of sleeve gastrectomy versus gastric bypass comparing males to females. The primary outcome was safety (mortality, complications, and reinterventions) up to 5 years after surgery. The secondary outcome was healthcare utilization (hospitalization and emergency department use). Among 95,405 patients the majority (n = 71,348; 74.8%) were female and most (n = 57,008; 59.8%) underwent sleeve gastrectomy. For all patients, compared to gastric bypass, sleeve gastrectomy was associated with a lower risk of complications and reintervention but a higher risk of revision. Compared to gastric bypass, sleeve gastrectomy was associated with a lower risk of mortality for females (adjusted hazard ratio .86, 95% CI .75-.96) but not males. We found no difference in procedure treatment effect by sex for mortality, hospitalization, emergency department use, or overall reintervention when comparing sleeve to gastric bypass. Females and males have similar outcomes following bariatric surgery. Females have a lower risk of complications but a higher risk of reintervention. Decisions surrounding treatment for this common procedure should be tailored to include a discussion of sex-specific differences in treatment outcome.

Should mitral valve replacement age guidelines be lowered due to better bioprosthetic mitral valve durability?

ObjectiveGuideline recommendations for mechanical or bioprosthetic valve for mitral valve replacement by age remains controversial. We sought to determine bovine pericardial valve durability by age and risk of reintervention. MethodsThis retrospective study between 2 large university-based cardiac surgery programs examined patients who underwent bioprosthetic mitral valve replacement from 2004 to 2020. Follow-up was obtained through June 2022. Durability outcomes involving structural valve deterioration were compared by age decile. ResultsOf 1544 available patients, mean age was 66 ± 13 years and 652 (42%) were aged less than 65 years. Indications for mitral valve replacement were as follows: mitral regurgitation greater than 2+ in 53% (n = 813), mitral stenosis in 44% (n = 650), endocarditis in 18% (n = 277), and reoperation in 39% (n = 602). Concomitant procedures were aortic valve replacement in 28% (n = 426), tricuspid valve in 36% (n = 550), and coronary artery bypass in 19% (n = 290). Thirty-day mortality was 5.4%. In follow-up (clinical: median [interquartile range] 75 [25-129] months), reoperation for endocarditis and new stroke were low (0.30 and 1.06 per 100 patient/years, respectively). The cumulative incidence of mitral valve reintervention for structural valve deterioration among all patients was 6.2% at 10 years and 9.0% at 12 years with no statistical difference in structural valve deterioration in patients aged 40 to 70 years (P = .1). In 90 patients with mitral valve reintervention, 30-day mortality after reintervention was 4.7% (n = 2) for 43 with mitral valve-in-valve and 6.4% (n = 3) for 47 with reoperation. ConclusionsBovine pericardial mitral valve replacement is a durable option for younger patients. The opportunity to avoid anticoagulation and the associated risks with mechanical mitral valve replacement may be of benefit to patients. These insights may provide data needed to revise the current guidelines.

Comparison of middle-term valve durability between transcatheter aortic valve implantation and surgical aortic valve replacement: an updated systematic review and meta-analysis of RCTs.

This study aims to compare valve durability between transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR). We conducted a systematic review and meta-analysis using data from randomized controlled trials (RCTs). The primary outcome was structural valve deterioration (SVD). Secondary outcomes were bioprosthetic valve failure, reintervention, effective orifice area (EOA), mean pressure gradient, and moderate-severe aortic regurgitation (AR, transvalvular and/or paravalvular). Twenty-five publications from seven RCTs consisting of 7,970 patients were included in the analysis with follow-up ranges of 2-8 years. No significant difference was found between the two groups with regard to SVD [odds ratio (OR) 0.72; 95% CI: 0.25-2.12]. The TAVI group was reported to exhibit a statistically significant higher risk of reintervention (OR 2.03; 95% CI: 1.34-3.05) and a moderate-severe AR (OR 6.54; 95% CI: 3.92-10.91) compared with the SAVR group. A trend toward lower mean pressure gradient in the TAVI group [(mean difference (MD) -1.61; 95% CI: -3.5 to 0.28)] and significant higher EOA (MD 0.20; 95% CI: 0.08-0.31) was noted. The present data indicate that TAVI provides a comparable risk of SVD with favorable hemodynamic profile compared with SAVR. However, the higher risk of significant AR and reintervention was demonstrated. PROSPERO (CRD42022363060).

Comparison of Safety of Leadless Pacemakers and Transvenous Pacemakers: A Meta-Analysis.

Pacemakers have been accessible for six decades, and clearly defined criteria for pacemaker implantation have been established. Within the contemporary clinical practice, two dependable pacing platforms exist leadless pacemakers and transvenous pacemakers. The aim of this meta-analysis is to compare the safety of leadless pacemakers to transvenous pacemakers.This meta-analysis adhered to the guidelines outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 framework.A comprehensive and systematic search was conducted across various databases including Scopus, Cochrane Library, and EMBASE, spanning from inception to August 15, 2023.The primary outcomes assessed in this meta-analysis were total complications, all-cause mortality, and device-related complications. Furthermore, secondary outcomes evaluated encompassed the need for reintervention, occurrences of pneumothorax, pericardial effusion, endocarditis, hemothorax, and hematoma. Total 17 studies were included in this meta-analysis. The findings of this study showed that patients with leadless pacemakers had a lower risk of total complications, device-related complications, pneumothorax, and endocarditis. The risk of reintervention was significantly lower in the leadless pacemaker group. However, compared to a transvenous pacemaker, the risk of pericardial effusion was significantly higher in the leadless pacemaker group.It is important to acknowledge the limitations arising from the lack of extensive long-term follow-up data for leadless pacemakers. As technology evolves, continued research will be essential in uncovering the full spectrum of prolonged complications associated with these devices.

Neck radiation is not associated with increased risk of perioperative adverse events after transcarotid artery revascularization or transfemoral carotid artery stenting

ObjectiveIt is unclear whether patients with prior neck radiation therapy (RT) are at high risk for carotid artery stenting (CAS). We aimed to delineate 30-day perioperative and 3-year long-term outcomes in patients treated for radiation-induced stenotic lesions by the transfemoral carotid artery stenting (TFCAS) or transcarotid artery revascularization (TCAR) approach to determine comparative risk and to ascertain the optimal intervention in this cohort. MethodsData were extracted from the Vascular Quality Initiative CAS registry for patients with prior neck radiation who had undergone either TCAR or TFCAS. The Student t-test and the χ2 test were used to compare baseline patient characteristics. Multivariable logistic regression and Cox Hazard Proportional analysis were used to compare perioperative and long-term differences between patients with and without prior neck radiation following TCAR and TFCAS. Kaplan-Meier estimator was used to determine the incidence of 3-year adverse events. ResultsA total of 72,656 patients (TCAR, 40,879; TFCAS, 31,777) were included in the analysis. Of these, 4151 patients had a history of neck radiation. Patients with a history of neck radiation were more likely to be younger, white, and have fewer comorbidities than patients with no neck radiation history. After adjustment for confounding factors, there was no difference in relative risk of 30-day perioperative stroke (P = .11), death (P = .36), or myocardial infarction (MI) (P = .61) between TCAR patients with or without a history of neck radiation. The odds of stroke/death (P = .10) and stroke/death/MI (P = .07) were also not statistically significant. In patients with prior neck radiation, TCAR had lower odds for in-hospital stroke/death/MI (odds ratio, 0.59; 95% confidence interval [CI], 0.35-0.99; P = .05) and access site complications than TFCAS. At year 3, patients with prior neck radiation had an increased hazard for mortality after TCAR (hazard ratio [HR], 1.24; 95% CI, 1.02-1.51; P = .04) and TFCAS (HR, 1.33; 95% CI, 1.12-1.58; P = .001). Patients with prior neck radiation also experienced an increased hazard for reintervention after TCAR (HR, 2.16; 95% CI, 1.45-3.20; P < .001) and TFCAS (HR, 1.67; 95% CI, 1.02-2.73; P<.001). ConclusionsPatients with prior neck radiation had a similar relative risk of 30-day perioperative adverse events as patients with no neck radiation after adjustment for baseline demographics and disease characteristics. In these patients, TCAR was associated with reduced odds of perioperative stroke/death/MI as compared with TFCAS. However, patients with prior neck radiation were at increased risk for 3-year mortality and reintervention.

Long-Term Outcomes of Patients Undergoing Aortic Root Replacement WithMechanical Versus Bioprosthetic Valves: Meta-Analysis of Reconstructed Time-to-Event Data.

Background An aspect not so clear in the scenario of aortic surgery is how patients fare after composite aortic valve graft replacement (CAVGR) depending on the type of valve (bioprosthetic versus mechanical). We performed a study to evaluate the long-term outcomes of both strategies comparatively. Methods and Results Pooled meta-analysis of Kaplan-Meier-derived time-to-event data from studies with follow-up for overall survival (all-cause death), event-free survival (composite end point of cardiac death, valve-related complications, stroke, bleeding, embolic events, and/or endocarditis), and freedom from reintervention. Twenty-three studies met our eligibility criteria, including 11 428 patients (3786 patients with mechanical valves and 7642 patients with bioprosthetic valve). The overall population was mostly composed of men (mean age, 45.5-75.6 years). In comparison with patients who underwent CAVGR with bioprosthetic valves, patients undergoing CAVGR with mechanical valves presented no statistically significant difference in the risk of all-cause death in the first 30 days after the procedure (hazard ratio [HR], 1.24 [95% CI, 0.95-1.60]; P=0.109), but they had a significantly lower risk of all-cause mortality after the 30-day time point (HR, 0.89 [95% CI, 0.81-0.99]; P=0.039) and lower risk of reintervention (HR, 0.33 [95% CI, 0.24-0.45]; P<0.001). Despite its increased risk for the composite end point in the first 6 years of follow-up (HR, 1.41 [95% CI, 1.09-1.82]; P=0.009), CAVGR with mechanical valves is associated with a lower risk for the composite end point after the 6-year time point (HR, 0.46 [95% CI, 0.31-0.67]; P<0.001). Conclusions CAVGR with mechanical valves is associated with better long-term outcomes in comparison with CAVGR with bioprosthetic valves.

Biliary drainage in malignant biliary obstruction: an umbrella review of randomized controlled trials.

There are still many controversies about biliary drainage in MBO, and we aimed to summarize and evaluate the evidence associated with biliary drainage. We conducted an umbrella review of SRoMAs based on RCTs. Through July 28, 2022, Embase, PubMed, WOS, and Cochrane Database were searched. Two reviewers independently screened the studies, extracted the data, and appraised the methodological quality of the included studies. GRADE was used to evaluate the quality of the evidence. 36 SRoMAs were identified. After excluding 24 overlapping studies, 12 SRoMAs, including 76 RCTs, and 124 clinical outcomes for biliary drainage in MBO were included. Of the 124 pieces of evidence evaluated, 13 were rated "High" quality, 38 were rated "Moderate", and the rest were rated "Low" or "Very low". For patients with MBO, 125I seeds+stent can reduce the risk of stent occlusion, RFA+stent can improve the prognosis; compared with PC, SEMS can increase the risk of tumor ingrowth and reduce the occurrence of sludge formation, and the incidence of tumor ingrowth in C-SEMS/PC-SEMS was significantly lower than that in U-SEMS. There was no difference in the success rate of drainage between EUS-BD and ERCP-BD, but the use of EUS-BD can reduce the incidence of stent dysfunction. For patients with obstructive jaundice, PBD does not affect postoperative mortality compared to direct surgery. The use of MS in patients with periampullary cancer during PBD can reduce the risk of re-intervention and stent occlusion compared to PC. In addition, we included four RCTs that showed that when performing EUS-BD on MBO, hepaticogastrostomy has higher technical success rates than choledochoduodenostomy. Patients who received Bilateral-ENBD had a lower additional drainage rate than those who received Unilateral-ENBD. Our study summarizes a large amount of evidence related to biliary drainage, which helps to reduce the uncertainty in the selection of biliary drainage strategies for MBO patients under different circumstances.

Comparison Study between Artificial Urinary Sphincter and Adjustable Male Sling: A Propensity-Score-Matched Analysis.

This study aimed to compare the outcomes of the AUS and an adjustable male sling (ATOMSTM). It was a retrospective observational cohort study with two arms. Propensity score matching (PSM) was performed in order to limit selection bias and, consequently, a comparison between groups in terms of functional outcomes (24 h pad test and perception of improvement questionnaires), complications (overall complications, high-grade complications, reinterventions and explantations) and device survival was performed. 49 patients in both arms were included. The baseline characteristics were similar between the groups. The mean follow up was 43 ± 35 months. Dryness was achieved in 22 patients (44.9%) in the AUS group and 11 (22.5%) in the sling group (p = 0.03). A total of 40 patients declared themselves well improved in the sling group (81%), while 35 (71%) declared the same in the AUS group (p = 0.78). The AUS was associated with more high-grade complications, reinterventions and explantations than the ATOMSTM. Survival at 60 months was 82 ± 9% in the sling group and 67 ± 7% in the AUS group (p = 0.03). While the AUS may be characterized by a higher dry rate, it has an increased risk of high-grade complications and reinterventions. It is proposed that the ATOMS prosthesis can be successfully used for patients who require a less invasive procedure that maintains good functional outcomes.