Intermediate-term Results Research Articles

Assessment of Right Ventricular Reverse Remodeling in Infants with Critical Pulmonary Stenosis after Balloon Pulmonary Valvuloplasty Using 3D Echocardiography

Abstract Aim and Objectives The aim of this study is to identify role of 3D echocardiographic assessment of RV volumes and function in infants with critical pulmonary stenosis undergoing balloon pulmonary valvuloplasty pre and post dilatation, the immediate and intermediate term outcome of relieving obstruction on RV volumes Patients and Methods The study included all infants who were referred for elective or urgent BPV in the congenital and structural heart disease Unit, Cardiology department, Ain Shams University because of critical pulmonary stenosis and are followed for 3-6 months after the procedure since first of December 2020 till end of august 2021. Results sixty infants with critical PS with a median age of 8.5 months were subjected to BPV, immediately after the procedure there was significant reduction in RVSP (P < 0.01), there was significant increase in TAPSE, Annulus and FAC by 2D echocardiography immediately post procedure and at 3-6 month follow up (P < 0.01), while there was significant decrease in PG immediately post procedure and throughout a follow up period of 3-6 month (P < 0.01), The indexed RV wall thickness and indexed RA area showed no significant change between pre and immediately post procedure while there was significant decrease at 3-6 month than pre and immediately post (P < 0.01), The indexed End-Diastolic and End systolic volumes by 3D Echocardiography decreased insignificantly immediately post procedure (P = 0.421) (P = 0.317) respectively while it decreased significantly at 3-6 month follow up (P < 0.05), The right ventricle Ejection fraction, FAC and TAPSE by 3D echocardiography increased significantly immediately post procedure and throughout a follow up period of 3-6 month (P < 0.01), The Basal RV dimension by 3D echocardiography decreased insignificantly immediately post procedure (P = 0.057)while there was significant decrease at 3-6 month than pre and immediately post (P < 0.01), The mid RV dimension and Longitudinal RV dimension by 3D Echocardiography decreased significantly immediately post procedure and at 3-6 month follow up (P < 0.01). Conclusion BPV is safe and effective to relieve critical PS. The balloon promotes advantageous changes in pulmonary annulus RVSP, PG and FAC by two dimensional echo across the RVOT. In addition, the Doppler gradient observations during the follow-up support the expectation that BPV is a ‘curative’ therapy and Three-dimensional echocardiography is an effective method to assess RV volumes and function Abbreviations RV: Right ventricle; CHD: Congenital heart disease; BPV: Balloon pulmonary valvuloplasty; LV: Left ventricle; PS: Pulmonary stenosis; HF: Heart failure; RVSP: Right ventricle systolic pressure; ASD: Atrial septal defect; TAPSE: Tricuspid annular peak systolic excursion; PFO: patent foramen ovale; FAC: Fractional area change; VSD: Ventricular septal defect; PG: Pressure gradient; PDA: patent ductus arterioses; RA: Right atrium; RVES: Right ventricle end systole; RVOT: Right ventricle outflow tract; RVED: Right ventricle end diastole; CMR: Cardiac magnetic resonance

Contemporary outcomes of pediatric cardiac transplantation with a positive retrospective crossmatch.

A positive crossmatch (+ XM) has traditionally been associated with adverse outcomes following pediatric heart transplantation. However, more recent studies suggest that favorable intermediate-term outcomes may be achieved despite a + XM. This study's hypothesis is that children with a + XM have similar long-term survival, but higher rate of complications such as rejection, coronary allograft vasculopathy (CAV), and infection, compared to patients with a negative (-) XM. The Pediatric Heart Transplant Society Registry (PHTS) database was queried from 2010-2021 for all patients <18 years of age with a known XM. Baseline demographics were compared between + XM and - XM groups using appropriate parametric and non-parametric group comparisons. Cox Proportional Hazards Modeling was used to identify risk factors for post-transplant graft loss, rejection, and CAV. Of 4599 pediatric heart transplants during the study period, XM results were available for 3914 (85%), of which 373 (9.5%) had a + XM. Univariate analysis showed lower 10-year survival for patients with + XM (HR = 1.3, p = .04). Multivariate analyses revealed no significant difference in 10-year survival in the 2 groups; however, time to first rejection (p = .0001) remained significantly shorter in the + XM group. Pediatric patients transplanted across a + XM experience earlier rejection; however, after multivariate adjustment, + XM is not independently associated with intermediate-term graft loss. The risk of heart transplantation against a + XM must be balanced with the ongoing risk of waitlist mortality.

Outcomes of ankle joint distraction in a paediatric and young adult cohort presenting with symptomatic ankle arthritis.

Ankle arthritis in paediatric and young adult patients causes significant morbidity; therefore, joint-preserving procedures are preferable. Ankle joint distraction (AJD) is a technique that preserves the native joint. However, only short-term outcomes are reported in paediatric patients. Therefore, this study reports on intermediate-term outcomes in a paediatric cohort. Demographics for all patients who underwent AJD at two centres were prospectively collected. Case records were reviewed retrospectively for complications and further intervention. Mean joint space at baseline and follow-up radiographs were evaluated by two independent observers. All patients were contacted for completion of a Foot and Ankle Outcome Score (FAOS). Seven patients received AJD between February 2016 and June 2019. Median age at surgery was 15 years (9.0-24.6 years). Complications included one superficial pin-site infection and one patient death due to complications from juvenile idiopathic arthritis 6.2 years post-operatively. Two patients were converted to fusion, at 12.6 months and 26.2 months following frame removal; one patient underwent spontaneous fusion at 9 months following frame removal. The four patients who continued without further intervention achieved 2.59 mm mean joint space at last follow-up (0.65-5.08 mm) and FAOS of 35-79%. Mean follow-up length was 4.3 years (2.9-6.3 years) with final radiographs at mean 2.6 years. While recognising the limitations of this retrospective review, several patients had significant, sustained improvements in joint space with good clinical outcome. Complications for this procedure are minimal, and it is a potential joint-preserving option for managing end-stage ankle arthritis in young patients.

A Multi-Institutional Report of Intermediate-Term Kidney Outcomes in Uterus Transplant Recipients

A Multi-Institutional Report of Intermediate-Term Kidney Outcomes in Uterus Transplant Recipients

Diagnosis related group and outcomes following transcatheter aortic valve implantation.

The association between Medicare Severity-Diagnosis Related Group (DRG) and early and intermediate-term outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) has not been well studied. We aimed to assess the relationship between DRG and 30-day and 1-year mortality in patients undergoing TAVI. The study population included 289 patients with severe symptomatic AS who underwent TAVI from December 2015 to June 2018 at an academic tertiary care medical center. Patients were categorized as DRG 266 or DRG 267, specifying TAVI with or without major complication or comorbidities respectively. Of the 289 patients, 182 patients (63.0%) were classified under DRG 267 and 107 patients (37.0%) under DRG 266. The DRG 266 group had longer hospital lengths of stay and higher rates of discharge to a skilled nursing facility. While rates of in-hospital and 30-day mortality were similar in both DRG groups, the DRG 266 group had higher 1-year all-cause mortality (26.2% vs 8.8%, P less than .001). In multivariable analysis, serum creatinine (OR 1.42, 95%CI 1.05-1.93) was the only independent predictor of 1-year mortality in the DRG 266 group while atrial fibrillation (OR 3.04, 95%CI 1.03-8.92) was the only independent predictor of mortality in the DRG 267 group. In this prospective registry of patients undergoing TAVI, while rates of in-hospital and 30-day mortality were similar in both DRG 266 and 267 groups, the DRG 266 group had higher 1-year all-cause mortality. Distinct predictors of mortality in each DRG group exist.

Association Between Rome Classification Among Hospitalized Patients With COPD Exacerbations and Short-Term and Intermediate-Term Outcomes

Recently, the Rome proposal updated the definition of exacerbation of COPD (ECOPD). However, such severity grade has not yet demonstrated intermediate-term clinical relevance. What is the association between the Rome severity classification and short-term and intermediate-term clinical outcomes? We retrospectively grouped hospitalized patients with ECOPD according to the Rome severity classification (ie, mild, moderate, severe). Baseline, clinical, microbiologic, gas analysis, and laboratory variables were collected. In addition, data about the length of hospital stay and mortality (in-hospital and a follow-up time line from 6months until 3 years) were assessed. Of the 347 hospitalized patients, 39%were categorized as mild, 31%were categorized as moderate, and 30%were categorized as severe. Overall, patients with severe ECOPD had an extended length of hospital stay. Although in-hospital mortality was similar among groups, patients with severe ECOPD presented a worse prognosis in all follow-up time points. The Kaplan-Meier curves show the role of the severe classification in the cumulative survival at 1 and 3 years (Gehan-Breslow-Wilcoxon test, P= .032 and P= .004, respectively). The multivariable Cox regression analysis showed a higher risk of death at 1 year when patients presented a severe (hazard ratio, 1.99; 95%CI, 1.49-2.65) or moderate grade (hazard ratio, 1.47; 95%CI, 1.10-1.97) compared with a mild grade. Older patients (aged ≥ 80 years), patients requiring long-term oxygen therapy, or patients reporting previous ECOPD episodes had a higher mortality risk. A BMI between 25 and 29kg/m2 was associated with a lower risk. The Rome classification makes it possible to discriminate patients with a worse prognosis (severe or moderate) until a 3-year follow-up.

Intermediate-Term Prognostic Value of Homocysteine in Acute Coronary Syndrome Complicated with or without Hypertension: A Multicenter Observational Cohort Study.

As a classical biomarker associated with hypertension, the prognostic value of homocysteine (Hcy) in the intermediate-term outcome of acute coronary syndrome (ACS) remains controversial. This study aimed to investigate the role of homocysteine in ACS patients with different blood pressure statuses. A total of 1288 ACS patients from 11 general hospitals in Chengdu, China, from June 2015 to December 2019 were consecutively included in this observational study. The primary endpoint was defined as all-cause death. Secondary endpoints included cardiac death, nonfatal myocardial infarction (MI), unplanned revascularization and nonfatal stroke. The patients in the hypertension group (n = 788) were further stratified into hyperhomocysteinemia (H-Hcy, n = 245) and normal homocysteinaemia subgroups (N-Hcy, n = 543) around the cut-off value of 16.81 µmol/L. Similarly, the nonhypertensive patients were stratified into H-Hcy (n = 200) and N-Hcy subgroups (n = 300) around the optimal cut-off value of 14.00 µmol/L. The outcomes were compared between groups. The median follow-up duration was 18 months. During this period, 78 (6.05%) deaths were recorded. Kaplan‒Meier curves illustrated that H-Hcy had a lower survival probability than N-Hcy in both hypertension and nonhypertension groups (p 0.01). Multivariate Cox regression analysis revealed that H-Hcy was a predictor of intermediate-term mortality in ACS, regardless of blood pressure status. Elevated Hcy levels predict intermediate-term all-cause mortality in ACS regardless of blood pressure status. This association could be conducive to risk stratification of ACS. The study was registered in the Chinese Clinical Trials Registry in China (ChiCTR1900025138).

Pulmonary valve reconstruction for acquired pulmonary regurgitation in patients with treated congenital heart disease.

Pulmonary valve regurgitation is a common problem after relief of right ventricular outflow tract (RVOT) obstruction with a transannular patch. Pulmonary valve replacement with a homograft or xenograft is the routine treatment. Longevity of biological valves and the availability of homografts are limited. Alternatives to restore RVOT competence are evaluated. The goal of this study was to present intermediate-term results for pulmonary valve reconstruction (PVr) in patients with severe regurgitation. PVr was performed in 24 patients (August 2006‒July 2018). We analysed perioperative data, pre- and postoperative cardiac magnetic resonance (CMR) imaging studies, freedom from valve replacement and risk factors for pulmonary valve dysfunction. The underlying diagnoses were tetralogy of Fallot (n = 18, 75%), pulmonary stenosis (n = 5, 20.8%) and the double outlet right ventricle post banding procedure (n = 1, 4.2%). The median age was 21.5 (14.8-23.7) years. Main (n = 9, 37.5%) and branch pulmonary artery procedures (n = 6, 25%) and surgery of the RVOT (n = 16, 30.2%) were often part of the reconstruction. The median follow-up after the operation was 8.0 (4.7-9.7) years. Freedom from valve failure was 96% at 2 and 90% at 5 years. The mean longevity of the reconstructive surgery was 9.9 years (95% confidence interval: 8.8-11.1 years). CMR before and 6 months after surgery showed a reduction in the regurgitation fraction [41% (33-55) vs 20% (18-27) P = 0.00] and of the indexed right ventricular end-diastolic volume [156 ml/m2 (149-175) vs 116 ml/m2 (100-143), P = 0.004]. Peak velocity across the pulmonary valve (determined by CMR) half a year after surgery was 2.0, unchanged. PVr can be achieved with acceptable intermediate-term results and may delay pulmonary valve replacement.

Comparison of Outcomes Following Transcatheter Aortic Valve Replacement Requiring Peripheral Vascular Intervention or Alternative Access.

Background Peripheral vascular intervention (PVI) is occasionally required to facilitate delivery system insertion or to treat vascular complications during transfemoral transcatheter aortic valve replacement (TF-TAVR). However, the impact of PVI on outcomes is not well understood. Therefore, we aimed to compare outcomes between TF-TAVR with versus without PVI and between TF-TAVR with PVI versus non-TF-TAVR. Methods and Results We retrospectively reviewed 2386 patients who underwent TAVR with a balloon-expandable valve at a single institution from 2016 to 2020. The primary outcomes were death and major adverse cardiac/cerebrovascular event (MACCE), defined as death, myocardial infarction, or stroke. Of 2246 TF-TAVR recipients, 136 (6.1%) required PVI (89% bailout treatment). During follow-up (median 23.0 months), there were no significant differences between TF-TAVR with and without PVI in death (15.4% versus 20.7%; adjusted HR [aHR], 0.96 [95% CI, 0.58-1.58]) or MACCE (16.9% versus 23.0%; aHR, 0.84 [95% CI, 0.52-1.36]). However, compared with non-TF-TAVR (n=140), TF-TAVR with PVI carried significantly lower rates of death (15.4% versus 40.7%; aHR, 0.42 [95% CI, 0.24-0.75]) and MACCE (16.9% versus 45.0%; aHR, 0.40 [95% CI, 0.23-0.68]). Landmark analyses demonstrated lower outcome rates following TF-TAVR with PVI than non-TF-TAVR both within 60 days (death 0.7% versus 5.7%, P=0.019; MACCE 0.7% versus 9.3%; P=0.001) and thereafter (death 15.0% versus 38.9%, P=0.014; MACCE 16.5% versus 41.3%, P=0.013). Conclusions The need for PVI during TF-TAVR is not uncommon, mainly due to the bailout treatment for vascular complications. PVI is not associated with worse outcomes in TF-TAVR recipients. Even when PVI is required, TF-TAVR is associated with better short- and intermediate-term outcomes than non-TF-TAVR.

Outcomes After Isolated Aortic Valve Replacements in Patients With Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is a frequently encountered co-morbidity and is 1 of the main culprits for inoperability in cardiac surgeries among patients with aortic stenosis (AS). 1 Mok M Nombela-Franco L Dumont E Urena M DeLarochellière R Doyle D Villeneuve J Côté M Ribeiro HB Allende R Laflamme J DeLarochellière H Laflamme L Amat-Santos I Pibarot P Maltais F Rodés-Cabau J. Chronic obstructive pulmonary disease in patients undergoing transcatheter aortic valve implantation: insights on clinical outcomes, prognostic markers, and functional status changes. JACC Cardiovasc Interv. 2013; 6: 1072-1084 Crossref PubMed Scopus (82) Google Scholar ,2 Kumbhani DJ Kapadia SR Jneid H. Transcatheter or surgical aortic valve replacement in patients with chronic lung disease? The answer, my friend, is blowin’ in the Wind. J Am Heart Assoc. 2018; 7e008933 Crossref Google Scholar Aortic valve replacement (AVR) through surgical approach (surgical aortic valve replacement [SAVR]) carries a high risk of morbidity and mortality in patients with COPD on home-oxygen (home-O2), 3 Kumar K Morris CC Samhan A Herman T Chau T Lantz G Chadderdon SM Song HK Zahr FE Golwala H. Intermediate-term outcomes following transcatheter aortic valve implantation in patients with a history of supplemental home oxygen use. Am J Cardiol. 2022; 167: 159-160 Abstract Full Text Full Text PDF Scopus (0) Google Scholar ,4 Dvir D Waksman R Barbash IM Kodali SK Svensson LG Tuzcu EM Xu K Minha S Alu MC Szeto WY Thourani VH Makkar R Kapadia S Satler LF Webb JG Leon MB Pichard AD. Outcomes of patients with chronic lung disease and severe aortic stenosis treated with transcatheter versus surgical aortic valve replacement or standard therapy: insights from the PARTNER trial (placement of AoRTic transcatheter Valve). J Am Coll Cardiol. 2014; 63: 269-279 Crossref PubMed Scopus (81) Google Scholar which makes AVR through transcatheter approach (transcatheter aortic valve implantation [TAVI]) an increasingly attractive option in this patient population. 5 Doldi P Steffen J Orban M Theiss H Sadoni S Hagl C Massberg S Hausleiter J Deseive S Braun D. Clinical outcome following transcatheter aortic valve implantation in patients with chronic obstructive pulmonary disease. JACC Cardiovasc Interv. 2022; 15: 1188-1190 Crossref Scopus (1) Google Scholar However, the outcomes of home-O2 users among patients with AS and COPD who undergo different treatment strategies are not well understood. Hence, we compared the outcomes of home-O2 users and nonusers among patients with AS and COPD from a nationwide registry.

Carpal Tunnel Release With Ultrasound Guidance: Intermediate-Term Clinical Outcomes and Magnetic Resonance Imaging Findings

The purpose of this study was to report intermediate-term outcomes following carpal tunnel release using ultrasound guidance and wide-awake local anesthesia no tourniquet, including a subset of patients with preoperative and postoperative magnetic resonance imaging (MRI). In this observational study, patients with carpal tunnel syndrome were treated with carpal tunnel release using ultrasound guidance and wide-awake local anesthesia no tourniquet in a procedure room at a single center. Main outcomes were complications; return to activity and work at 2 weeks; Quick Disabilities of the Arm, Shoulder, and Hand and Boston Carpal Tunnel Questionnaire scores through 6 months; and postoperative morphological changes of the transverse carpal ligament, median nerve, and carpal tunnel evaluated using MRI. No complications were reported among 65 patients (68% women, 96 wrists). By 2 weeks, 97% of patients returned to normal activity and 100% returned to work. Statistically significant improvements in Boston Carpal Tunnel Questionnaire symptom severity scale, Boston Carpal Tunnel Questionnaire functional status scale, and Quick Disabilities of the Arm, Shoulder, and Hand scores occurred by the 2-week follow-up interval and persisted at 6 months (all P < .001). Pre- and postoperative MRI scans were available for 13 patients (17 wrists) at the 3-month mean follow-up. Complete transverse carpal ligament transection was documented in all wrists. Key MRI findings included a 22% increase in carpal tunnel cross-sectional area at the hamate (P < .001), a 52% increase in median nerve cross-sectional area at the hamate (P < .001), an 18% reduction in median nerve signal intensity (P= .002), a 38% reduction in the flattening ratio of the median nerve at the hamate (P < .001), a 33% reduction in the flattening ratio of the median nerve at the pisiform (P < .001), a 20% reduction in the flattening ratio of the carpal tunnel at the hamate (P < .001), and a palmar shift of the median nerve relative to the hamate in all cases. Carpal tunnel release using ultrasound guidance using wide-awake local anesthesia no tourniquet in a procedure room setting was safe, effective, and resulted in morphological changes that were consistent with carpal tunnel decompression as demonstrated by MRI. Therapeutic IV.

Intermediate-Term Outcomes Following Transcatheter Aortic Valve Implantation in Patients with a History of Chest Radiation Therapy: A Propensity Score Matched Analysis.

Chest radiation therapy (XRT) has been associated with a higher rate of mortality following surgical aortic valve replacement. We performed a single-center retrospective analysis of patients with severe AS who underwent TAVI from January 1 2012 to July 31 2020 comparing patients with and without XRT. A total of 915 patients met inclusion criteria, with a total of 50 patients found to have a history of XRT. At a mean follow-up of 2.4 years, unadjusted and propensity score matching analysis demonstrated no differences in mortality, heart failure or bleeding-related hospitalization, overall stroke, and 30-day pacemaker implantation in patients with and without XRT.

Prediction of long-term survival among patients with cirrhosis using time-varying models.

Risk prediction among patients with cirrhosis has historically focused on short-term (ie, 90 days) mortality among patients waitlisted for a transplant. Although several models have been developed to predict intermediate and longer term survivals, they have important limitations, namely, including only baseline laboratory and clinical variables to predict survival over a time horizon of years. We developed prediction models using time-varying laboratory and clinical data among patients with cirrhosis in the OneFlorida Clinical Research Consortium. We fit extended Cox models and assessed model discrimination and calibration in complete-case analysis and imputation of missing laboratory data. Among 15,277 patients, 9922 (64.9%) were included in the complete-case analysis. Final models included demographic (age and sex), time-updating laboratory (albumin, alanine transaminase, alkaline phosphatase, bilirubin, platelet, and sodium), and time-updating clinical (ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, and bleeding esophageal varices) variables. Model discrimination was excellent in the complete-case analysis [AUC and concordance-index (C-index) > 0.85] at 1-, 2-, 3-, 4-, and 5-year time points. Model performance was unchanged with the exclusion of race and ethnicity as model predictors. Model discrimination was excellent (C-index >0.8) when imputation was used for patients with 1 or 2 missing laboratory variables. Using data from a statewide sample of patients with cirrhosis, we developed and internally validated a time-updating model to predict survival with excellent discrimination. Based on its measures of discrimination (AUC and c-index), this model matched or exceeded the performance of other published risk models depending on the time horizon. If externally validated, this risk score could improve the care of patients with cirrhosis by improving counseling on intermediate and longer term outcomes to guide clinical decision-making and advanced care planning.

Transesophageal echocardiography-guided versus fluoroscopy-guided patent foramen ovale closure: A single center registry.

Percutaneous closure of patent foramen ovale (PFO) is conventionally performed under continuous transesophageal echocardiographic (TEE) guidance. We aimed to evaluate whether a simplified procedural approach, including pure fluoroscopy-guidance and final TEE control, as well as an aimed 'next-day-discharge' is comparable with the conventional TEE-guided procedure in terms of periprocedural and intermediate-term outcomes. All patients who underwent a PFO closure at our center between 2010 and 2022 were retrospectively included. Prior to June 2019 cases were performed with continuous TEE guidance (TEE-guided group). Since June 2019, only pure fluoroscopy-guided PFO closures have been performed with TEE insertion and control just prior to device release (fluoroscopy-guided group). We analyzed procedural aspects, as well as long term clinical and echocardiographic outcomes. In total 291 patients were included in the analysis: 197 in the TEE-guided group and 94 in the fluoroscopy-guided group. Fluoroscopy-guided procedures were markedly shorter (48±20 min vs. 25±9 min; p<.01). There was no difference in procedural complications, including death, major bleeding, device dislodgement, stroke or clinically relevant peripheral embolization between the two groups (.5% vs. 0%; p=.99). Hospital stay was also shorter with the simplified approach (2.5±1.6 vs. 3.5±1.2 days; p< .01), allowing 85% same-day discharges during the last 12 months of observation period. At 6±3 months echocardiographic follow-up a residual leakage was described in 8% of the TEE-guided cases and 2% of the fluoroscopy-guided cases (p= .08). While a complete TEE-free PFO closure might have potential procedural risks, our approach of pure fluoroscopy-guided with a brisk final TEE check seems to be advantageous in terms of procedural aspects with no sign of any acute or intermediate-term hazard and it could offer an equitable compromise between the two worlds: a complete TEE procedure and a procedure without any TEE.

Comparison of Intermediate-Term Clinical Outcomes Between Medial and Lateral Osteochondral Lesions of the Talus Treated With Autologous Osteochondral Transplantation.

The conventional operative method to treat an osteochondral lesion of the talus (OLT) is through bone marrow stimulation (BMS). Autologous osteochondral transplantation (AOT) is being used as an alternative option in cases with a large OLT, accompanying subchondral cyst, and/or failed BMS. We aimed to compare the intermediate-term clinical and radiologic results between medial and lateral OLTs after an AOT procedure. Among the patients who underwent AOT, 45 cases with at least 3 years' follow-up were included in this retrospective study. We had 15 cases of lateral lesions and selected 30 cases of medial lesions matched for age and gender. Lateral lesions were resurfaced without an osteotomy; medial lesion resurfacing was combined with a medial malleolar osteotomy. Clinical assessment was performed using the Foot and Ankle Outcome Score (FAOS) and Foot and Ankle Ability Measure (FAAM). Radiographic assessment included the irregularity of articular surface (subchondral plate), the progression of degenerative arthritis, and the change of the talar tilt. The mean FAOS and FAAM scores significantly improved after surgery in both groups. Up to 1 year postoperatively, there was significant difference in FAAM scores between the both groups (mean 75.3 points in medial group and 87.2 points in lateral group, P < .001). Delayed union or malunion of the malleolar osteotomy was found in 4 cases (13%) in the medial group. In addition, the progression of joint degeneration was observed in 3 cases (10%) in the medial group. There were no significant differences in the irregularity of articular surface and the change of talar tilt between both groups. A comparison between medial and lateral OLTs treated with AOT demonstrated comparable intermediate-term clinical outcomes. However, patients with medial OLT required a longer period to restore ability for daily and sport activities. In addition, we found more complications and higher rate of progression in the radiologic arthritis grade after medial malleolar osteotomy. Level IV, retrospective comparative study.

Intermediate-term outcomes of complement inhibition for prevention of antibody-mediated rejection in immunologically high-risk heart allograft recipients

Allosensitization represents a major barrier to heart transplantation. We previously reported favorable 1-year outcomes of complement inhibition at transplant in highly sensitized recipients. We now report a longer follow-up. In this single-arm trial (NCT02013037), 20 patients with panel reactive antibodies ≥70% and preformed donor-specific antibodies received eculizumab during the first 2 months post-transplant. The primary end-point was antibody-mediated rejection≥pAMR2 and/or left ventricular dysfunction. The median follow-up was 4.8 years. Beyond the first year post-transplant, there were no episodes of pAMR2 or greater and no Left Ventricular (LV) dysfunction. There were 3 deaths, 1 episode of pAMR1, and 1 patient with minimal de novo cardiac allograft vasculopathy. Compared to a matched control group, we observed a nonstatistically significant benefit of eculizumab with a lower incidence of the primary end-point or death (primary end-point: hazard ratio=0.50, 95% confidence interval=0.15-1.67,andp=0.26; mortality: hazard ratio=0.51, 95% confidence interval=0.13-2.07, andp=0.35). Our results support the utility of complement inhibition for high-immunological-risk recipients. CLINICAL TRIAL REGISTRATION: ClinincalTrials.gov, NCT02013037. https://clinicaltrials.gov/ct2/show/NCT02013037?term=eculizumab&cond=heart+transplantation&draw=2&rank=1.

Intermediate-term results of TachoSil grafting to correct residual curvature during inflatable penile prosthesis implantation in patients with Peyronie's disease.

Grafting techniques may be mandatory to improve residual penile curvature during inflatable penile prosthesis (IPP) implantation in Peyronie's disease patients. We aimed to report the intermediate-term outcomes of grafting with TachoSil (Corza Health, San Diego, USA) in patients with severe erectile dysfunction and concomitant complex Peyronie's disease through a prospective cohort study. We included 25 patients that underwent the PICS (penile implant in combination with Sealing) technique from 2017 to 2020 and were evaluated 24 months after surgery. Their mean age was 61.8 ± 8.7 years. Total straightness of the penis was achieved in 21 cases, while 4 (16%) patients presented a residual penile curvature of less than 15°. The mean penile length increased significantly (15 ± 1.2 to 16.4 ± 1.6 cm, p < 0.001). No intraoperative complications occurred, while, postoperatively, two patients developed fever and three scrotal hematoma, which resolved spontaneously. At three and six weeks, as well as at 24 months after surgery, no further complications occurred, and no cases of penile glans hyposensitivity were observed. At the 24-month follow-up evaluation, the 5-item score of the International Index of Erectile Function was 23.7 ± 1.4 (range: 20.5-25) and all patients responded positively to questions 2 and 3 of the sexual encounter profile questionnaire (p < 0.001 for all outcomes compared to baseline). Accordingly, the Erectile Dysfunction Inventory of Treatment Satisfaction score improved from 45.8 ± 6 at baseline to 25.6 ± 4.6 at 24 months, p < 0.001. Grafting with TachoSil to improve residual penile curvature during IPP is a safe and effective procedure. Nevertheless, careful patient selection and counseling, surgeon's experience with the technique, and strict postoperative penile rehabilitation are the main factors for treatment success and high satisfaction rates.

B-48 | Intermediate-Term Outcomes Following Transcatheter Aortic Valve Implantation in Patients With Paravalvular Leak

B-48 | Intermediate-Term Outcomes Following Transcatheter Aortic Valve Implantation in Patients With Paravalvular Leak

Rotablation for Octogenarians in a Modern Cathlab: Short- and Intermediate-Term Results.

There are limited reports on the treatment of complex calcified lesions using rotational atherectomy (RA) in octogenarians, particularly in high-risk patients. To evaluate procedural and clinical outcomes of RA in octogenarians. Consecutive RA patients from 2010 to 2018 were selected from our catheterization laboratory database, stratified into two groups (≥ or < 80 years old), and analyzed. A total of 411 patients (269 males and 142 females) with a mean age of 73.8 ± 11.3 years were enrolled, of whom 153 were ≥ 80 years old and 258 were < 80 years old. Most of the patients displayed high-risk features. The baseline Syntax scores were high in both groups, and most lesions were heavily calcified (96.1% vs. 97.3%, p = 0.969, respectively). The use of hemodynamic support intra-aortic balloon pump was more frequent in the octogenarians (21.6% vs. 11.6%, p = 0.007), but the RA completion rate was similarly high (95.9% vs. 99.1%, p = 0.842). There was no difference in acute complications. The total/cardiovascular (CV) death rate within one year was higher in the octogenarians, along with higher major adverse cardiovascular event (MACE)/CV MACE rates in the first month. Cox regression analysis showed that age ≥ 80 years, acute coronary syndrome, ischemic cardiomyopathy/shock, multi-vessel disease and serum creatinine were all predictors of MACE, and that these factors plus peripheral artery disease were predictors of all-cause mortality in these patients. RA is feasible with a very high success rate in high-risk octogenarians with complex anatomies, and with equal safety and no increase in complications. The higher rates of all-cause death and MACE were attributed to an older age and other traditional risk factors.

PO-03-026 ACUTE PROCEDURAL AND INTERMEDIATE-TERM LEAD PERFORMANCE OF LEFT BUNDLE BRANCH AREA PACING

Left bundle branch area pacing (LBBAP) has demonstrated stable short and intermediate-term electrophysiological outcomes. To evaluate acute procedural and intermediate-term follow up electrophysiological outcomes of LBBAP. Patients undergoing LBBAP between February 2019 and September 2022 were prospectively analyzed. Implantation characteristics, electrocardiographic outcomes, and echocardiographic outcomes were assessed at time of implant and at time of follow-up. LBBAP was successful in 597/662 patients (90.2%). Lead revision/dislodgement occurred in 2% of the patients. Median follow up was 476 days (IQR 247-754), with mean 506 ± 324 days. Baseline demographics are listed in Table 1. Patients had baseline QRS duration of 117.3 ± 32.3 ms. Pacemaker indications were sinus nodal dysfunction (40.2%), atrioventricular block (36.3%), cardiac resynchronization therapy (7.4%), and refractory atrial fibrillation (16.1%). Mean procedure duration and fluoroscopic time were 89.7 ± 27.6 min and 11.4 ± 7.9 min, respectively. Mean LVAT at high and low output were 72.5 ± 10.9 ms and 75.8 ± 11.4 ms, respectively. Paced QRS duration was 117.2 ± 12.8 ms, and stim-QRS latency was 22.0 ± 9.0 ms. Paced V1 morphologies were qR (64.1%), rSR (6.7%), and QS (29.2%). Pre procedure left-ventricular ejection fraction (LVEF) was 54.5 ± 11.2%, and it remained stable at post-implant with value of 54.7 ± 9.7% (p>0.5). Capture threshold, lead impedance, and R waves at different follow up periods were stable at follow-up, compared to 1-month follow up, despite statistical significance (Figure 1). LBBAP demonstrates stable intermediate-term electrophysiological and echocardiographic parameters, proving itself to be a reliable approach to conduction system pacing.