Probability Of Freedom Research Articles

Freedom from infection: enhancing decision-making for malaria elimination

Assessing elimination of malaria locally requires a surveillance system with high sensitivity and specificity to detect its presence without ambiguity. Currently, the WHO standard criteria of observing the absence of...

Progress in Paratuberculosis Control Programmes for Dairy Herds.

While paratuberculosis control has been studied for over a century, knowledge gaps still exist regarding the uptake and efficacy of control programmes. This narrative review aims to summarise studies on control programmes presented at the IDF ParaTB Fora in 2021 and 2022 and the International Colloquium on Paratuberculosis in 2022. Studies were grouped by topic as follows: successful control, field studies, education and extension, voluntary and compulsory control programmes, and surveillance. Various Map control programmes resulted in a decreasing animal and herd level Map prevalence. Long-term stakeholder commitment, stable funding, involvement of herd veterinarians and incentives for farmers to participate were shown to be pivotal for long-term success. Control measures focused on vertical and calf-to-calf transmission may improve Map control in infected herds. Easy-to-capture visualisation of surveillance test results to inform participants on the progress of Map control in their herds was developed. The probability of freedom from disease and estimated within-herd prevalence were identified as good candidates for categorisation of herds to support low-risk trade of cattle. Results of the surveillance schemes may inform genetic selection for resistance to Map infection. In conclusion, successful paratuberculosis control is feasible at both the herd and country level provided that crucial prerequisites are met.

Long-term results of ablation index guided atrial fibrillation ablation: insights after 5+ years of follow-up from the MPH AF Ablation Registry.

Catheter ablation (CA) for symptomatic atrial fibrillation (AF) offers the best outcomes for patients. Despite the benefits of CA, a significant proportion of patients suffer a recurrence; hence, there is scope to potentially improve outcomes through technical innovations such as ablation index (AI) guidance during AF ablation. We present real-world 5-year follow-up data of AI-guided pulmonary vein isolation. We retrospectively followed 123 consecutive patients who underwent AI-guided CA shortly after its introduction to routine practice. Data were collected from the MPH AF Ablation Registry with the approval of the institutional research board. Our patient cohort was older, with higher BMI, greater CHA2DS2-VASc scores, and larger left atrial sizes compared to similar previously published cohorts, while gender balance and other characteristics were similar. The probability of freedom from atrial arrhythmia with repeat procedures is as follows: year 1: 0.95, year 2: 0.92, year 3: 0.85, year 4: 0.79, and year 5: 0.72. Age >75 years (p = 0.02, HR: 2.7, CI: 1.14-6.7), BMI >35 kg/m2 (p = 0.0009, HR: 4.6, CI: 1.8-11.4), and left atrial width as measured on CT in the upper quartile (p = 0.04, HR: 2.5, CI: 1-5.7) were statistically significant independent predictors of recurrent AF. AI-guided CA is an effective treatment for AF, with 95.8% of patients remaining free from atrial arrhythmia at 1 year and 72.3% at 5 years, allowing for repeat procedures. It is safe with a low major complication rate of 1.25%. Age >75 years, BMI >35 kg/m2, and markedly enlarged atria were associated with higher recurrence rates.

Survival and Freedom From Reinterventions in Patients With Repaired Tetralogy of Fallot: Up to 42-Year Follow-Up of 917 Patients.

Background To evaluate long-term outcome of tetralogy of Fallot repair analyzing an unbiased country-wide surgically treated population with tetralogy of Fallot. Methods and Results Retrospective analysis of consecutive patients aged <18 years who underwent tetralogy of Fallot repair at a single nationwide pediatric cardiac center. Death from any cause and need for surgical or catheter reintervention were thestudy end points. Cox regression analysis was used to identify related risk factors. A total of 917 patients (male, 56.3%) were analyzed. Staged repair was performed in 16.9%. Early mortality (24/917, 2.62% patients) was confined to the early surgical eras. Late mortality was 4.5% (40/893 patients). Survival probability was 95.1%, 93.8% and 91.9% at 10, 20 and 30 years after repair, respectively. Early surgical era (P=0.013) and surgical/catheter reinterventions (P<0.001) were multivariable predictors of late death. A total of 487 reinterventions were performed after initial repair in 253/917 patients (27.6%), with pulmonary artery revalvulation (196/917 patients, 21.4%) being most frequent. Probability of freedom from first reintervention was 89.0%, 73.3%, and 55.1% at 10, 20, and 30 years after primary repair, respectively. Transannular repair was associated with the need for pulmonary artery revalvulation (P<0.001). Patients who underwent staged repair were more likely to need reinterventions on pulmonary arteries (P<0.001). Conclusions In an unbiased nationwide cohort, tetralogy of Fallot repair carried a favorable survival of >90% at 30 years. Each reintervention significantly incrementally increased the risk of mortality. Type of initial repair predicted the need for specific surgical or catheter reinterventions.

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.

Long-term follow-up after endovascular treatment of aortic coarctation with bare and covered Cheatham platinum stents.

Endovascular treatment of aortic coarctation (CoA) in children and adults frequently requires stent implantation. The aim of this study was to analyze long-term results after CoA treatment with bare and covered Cheatham-PlatinumTM (CP) stents in our institution and to derive recommendations for the differential use of these stent types. In this retrospective single institution study, 212 patients received endovascular CoA treatment with bare (n = 71) and covered (n = 141) CP stents between September 1999 and July 2021, respectively. The indications for treatment were native CoA in 110/212 patients (51.9%) and re-coarctation after primary surgical or interventional treatment in 102/212 patients (48.1%). Median patient age at endovascular CoA treatment was 18.8 years [IQR 11.9; 35.8]. Long-term follow-up was available in 158/212 patients (74.5%) with a median follow-up of 7.3 years [IQR 4.3; 12.6]. Procedural success was achieved in 187/212 (88.2%) patients. Survival rate was 98.1% after 5, and 95.6% after 10 and 15 years, respectively. The probability of freedom from re-intervention was 93.0% after 5, 82.3% after 10 and 77.8% after 15 years, respectively. Freedom from re-interventions (44/158, 27.8%) did not differ between patients who received bare or covered CP stents (p = 0.715). Multivariable risk factor analysis identified previous CoA surgery (HR: 2.0, 95% confidence interval (CI): 1.1-3,9, p = 0.029), postdilatation (HR: 2,9, 95% CI: 1.1-6.3, p = 0.028) and age at intervention (HR: 0.96, 95% CI: 0.94-0.99, p = 0.002) as independent risk factors for re-intervention. Peri-procedural complications occurred in 15/212 (7.1%) patients (dissection/thrombosis of vascular access vessel: n = 9; bleeding: n = 1; stent dislocation: n = 2; aortic dissection/aortic wall rupture: n = 3). Long-term complications were observed in 36 patients and included stent fracture (n = 19), aneurysm formation (n = 14), endoleak (n = 1) and subclavian artery stenosis (n = 2). Peri-procedural and long-term complications did not differ between patients who received CoA treatment with bare or covered CP stents (all p > 0.05). Endovascular treatment of CoA using bare or covered CP stents can be performed safely and effectively with excellent long-term results. Survival, re-intervention and complication rate did not significantly differ between both stent types. However, individual stent selection is advisable with regard to CoA morphology and severity as well as patient age.

Fate of transposition of the great arteries with pulmonary stenosis after double-root translocation, Rastelli, and Réparation à l’Etage Ventriculaire

ObjectivesFor transposition of the great arteries with unrestricted ventricular septal defect and pulmonary stenosis, double-root translocation is reported to reconstruct ideal double artery roots with growth potential. However, prospective long-term studies describing the long-term outcomes are still scarce. Therefore, the aim was to assess development of double artery roots, hemodynamics, and freedom from death and heart failure 17 years after double-root translocation, Rastelli, and Réparation à l’Etage Ventriculaire procedures. MethodsIn this prospective population-based study, 266 patients with transposition of the great arteries/ventricular septal defect/pulmonary stenosis (from July 2004 to August 2021) were consecutively included before surgery. All patients were divided into 3 groups based on the type of operation: double-root translocation (174), Rastelli (68), and Réparation à l’Etage Ventriculaire (24), who accepted postoperative evaluations annually. Generalized linear mixed model analysis was performed to determine growth potential of artery roots. ResultsLongitudinal repeated computed tomography measurements show the pulmonary root has significantly increased diameter (0.62 [0.03] mm/y, P < .001) over time and an adequate Z-score (−0.18) at the last follow-up only in the double-root translocation group. The pressure gradients of double outflow tracts in the double-root translocation group were the least among 3 groups. The probabilities of freedom from death/heart failure at the 15th year were 73.1%, 59.3%, and 60.9% in the double-root translocation, Rastelli, and Réparation à l’Etage Ventriculaire groups, respectively (double-root translocation vs Rastelli, P = .026; double-root translocation vs Réparation à l’Etage Ventriculaire, P = .009; Rastelli vs Réparation à l’Etage Ventriculaire, P = .449). ConclusionsBy reconstructing ideal double artery roots, double-root translocation can provide postoperative long-term excellent hemodynamics and minimal death and heart failure for patients with transposition of the great arteries/ventricular septal defect/pulmonary stenosis.

The Impact of Patient Sex on Outcomes after Endovascular Treatment of Aortoiliac Occlusive Disease

The aim of this study was to explore the effect of patient sex on short and long-term outcomes after endovascular treatment for aortoiliac occlusive disease (AIOD). A multi-center retrospective analysis was performed on all patients who underwent iliac artery stenting for aorto-iliac occlusive disease across the three participating sites from October 1, 2018 to September 21, 2021. Preoperative clinical, operative, and post-operative data were collected on a dedicated database. Demographics and outcomes were compared between male and female patients and the probability of freedom from amputation and freedom from target lesion reintervention were estimated with the Kaplan-Meier method. Of 574 patients, 346 (60%) were male and 228 (40%) were female. Mean follow-up was 12 months. Female patients were significantly older (69.2 ± 10.2 years vs. 67.8 ± 8.9 years, p=0.025) and more likely to have Trans-Atlantic Inter-Society Consensus (TASC II) D disease (p=0.003). The female cohort had significantly less coronary artery disease (40% vs. 50%, p=0.013), coronary stenting (14% vs. 21%, p=0.039), and coronary artery bypass grafting (13% vs. 25%, p < 0.001) than the male cohort, as well as less statin use (69% vs 80%, p=0.004). There were no differences in stent type, concomitant open surgery, intraoperative events or hospital length of stay. For 30-day post-operative complications, female patients had a significantly higher rate of thrombotic acute limb ischemia (2% vs. 0%, p=0.01), while male patients had a higher rate of amputation (4% vs. 9%, p=0.048). On mid-term outcomes, there was no difference in freedom from amputation or target lesion re-intervention between male and female patients (p=0.14, p=0.32 respectively). Female patients had lower incidence of cardiovascular risk factors but presented with higher TASC II classification and had higher rates of 30-day thrombotic acute limb ischemia. Male patients were more likely to require amputation within 30 days. Despite no differences in the mid-term, these short-term findings suggest that patient sex may be a relevant consideration in post-operative management and surveillance after endovascular treatment of AIOD.

Value of NT-proBNP and Galectin-3 as Biomarkers in the Follow-Up of Asymptomatic Elderly Patients with Severe Aortic Stenosis.

Recognizing symptoms in elderly patients with severe aortic stenosis (AS) can be a challenge. Serum biomarkers such as Galectin-3 or N-terminal prohormone B-type natriuretic peptide (NT-proBNP) are involved in remodeling and heart failure (HF) development and could support the diagnosis of AS. We set out to test the usefulness of NT-proBNP and Galectin-3 in predicting events in this population. We designed a prospective observational case-control study, including 50 asymptomatic patients older than 70 years, diagnosed with severe degenerative AS, and 50 control individuals. The NT-proBNP and Galectin-3 levels were measured. A follow-up was carried out at 12 months to determine the occurrence of hospital admission for HF, all-cause mortality or the appearance of symptoms. The patients with severe AS had higher Galectin-3 and NT-proBNP concentrations. The area under the receiver operating characteristic curve of the NT-proBNP was 0.812 (95% CI, 0.646-0.832), and that of the Galectin-3 was 0.633 (95% CI, 0.711-0.913). NT-proBNP was a good predictor of events [HR 3.45 (95% CI 1.32-9.03), p = 0.011]. A Kaplan-Meier analysis showed that the probability of freedom from events was significant in patients who exhibited a combination of higher NT-proBNP and Galectin-3 levels (log-rank p = 0.032). Therefore, NT-proBNP was the most reliable predictor of events in asymptomatic patients with severe AS. A combination of NT-proBNP and Galectin-3 levels may be vital in the clinical follow-up of these patients and in the decision-making process.

Congenitally corrected transposition with left ventricular outflow obstruction and cardiac malposition: One-and-a-half ventricular repair vs. Fontan pathway?

This study was to assess the mid-term results of the one-and-a-half ventricular repair (hemi-Mustard and bidirectional Glenn procedures combined with the Rastelli procedure) and Fontan pathway for correcting congenitally corrected transposition of great artery (ccTGA) patients with left ventricular outflow tract obstruction (LVOTO) and cardiac malposition. In this retrospective study, 74 consecutive ccTGA with LVOTO and cardiac malposition underwent the one-and-a-half ventricular repair (group A; 33 cases) and Fontan operation (group B; 41 cases) between October 2011 and March 2018. The Median follow-up time was 49 (20-84) and 42 (7-85) months in groups A and B, respectively. To estimate excise tolerance the 6-min walk test (MWT) was performed. No in-hospital death. Compared with group A, group B have significantly less CPB, mechanical ventilation time, and intensive care unit stay, but prolonged pleural effusions developed more frequently in Group B. The survival probability was 90.2% (95% CI, 80.2-100%) and 97.2% (95% CI, 92-100%) at 7 years (p = 0.300) in group A and B. The probability of freedom from re-intervention were 80.6% (95% CI, 66.5-97.6%) and 97.2% (95% CI, 92-100%) at 7 years (p = 0.110). Longitudinal repeated measured echo data at every follow-up time shows that group A has more systemic ventricular EF% (p < 0.001) and less moderate systemic ventricular valve regurgitation (p < 0.001) compared with group B. Estimated by 6 MWT, group A has better outcomes for 6-min walk distance. For correction of ccTGA with LVOTO and cardiac malposition, the one-and-a-half ventricular repair had superior midterm heart function and excise tolerance.

Trough Concentration Deficiency of Rivaroxaban in Patients With Nonvalvular Atrial Fibrillation Leading to Thromboembolism Events.

This retrospective study investigated factors influencing the steady-state trough concentrations (C trough ) of rivaroxaban in patients with nonvalvular atrial fibrillation (NVAF). We retrieved data from patients with NAVF who first started rivaroxaban anticoagulation at the Fujian Provincial Hospital from October 2017 to October 2020 through the electronic medical record system. Patients were followed for 1 year after the first dose of rivaroxaban, and the primary efficacy and safety end points were recorded. All follow-up visits were completed by October 2021. A C trough of <12 ng/mL was defined as C trough deficiency. Factors that influenced rivaroxaban C trough deficiency were investigated using multivariate binary logistic regression analysis. Kaplan-Meier survival curve analysis was used to determine differences between C trough deficiency and event-free survival. A total of 167 patients with NVAF were enrolled in the study, including 113 men and 54 women, with an average (± SD) age of 70.40 ± 12.46 years. High albumin levels were an independent protective factor against C trough deficiency (odds ratio, 0.932; P = 0.031). C trough deficiency was associated with the probability of freedom from thrombotic events ( P = 0.004); however, there were no significant differences in the probability of freedom from bleeding events ( P > 0.05). In conclusion, among the variables studied, a low albumin level was the main contributor to C trough deficiency. Rivaroxaban C trough deficiency also increased thrombotic events, but this was not associated with hemorrhagic events in Chinese patients with NVAF.

Initial Surgical Strategy for the Treatment of Type A Acute Aortic Dissection: Does Proximal or Distal Extension of the Aortic Resection Influence the Outcomes?

(1) Background: We sought to analyze and compare the outcomes in terms of early and late mortality and freedom from a redo operation in patients undergoing surgical treatment for a type A acute aortic dissection in relation to the initial surgical treatment strategy, i.e., proximal or distal extension of the aortic segment resection, compared with isolated resection of the supracoronary ascending aorta. (2) Methods: This is a retrospective study in which we included 269 patients who underwent operations for a type A acute aortic dissection in the Department of Cardiac Surgery of Tor Vergata University from May 2006 to May 2016. The patients were grouped according to the extent of the performed surgical treatment: isolated replacement of the supracoronary ascending aorta (NE, no extension), replacement of the aortic root (PE, proximal extension), replacement of the aortic arch (DE, distal extension), and both (BE, bilateral extension). The analyzed variables were in-hospital mortality, postoperative complications (incidence of neurological damage, renal failure and need for prolonged intubation), late mortality and need for a redo operation. (3) Results: Unilateral cerebral perfusion was performed in 49.3% of the patients, and bilateral perfusion—in 50.6%. The overall in-hospital mortality was 31.97%. In the multivariate analysis, advanced age, cardiopulmonary bypass time and preoperative orotracheal intubation were independent predictors of in-hospital mortality. In the population of patients who survived the surgery, the probability of survival at 92 months was 70 ± 5%, the probability of freedom from a redo operation was 71.5 ± 5%, the probability of freedom from the combined end-point death and a redo operation was 50 ± 5%. The re-intervention rate in the general population was 16.9%. The overall probability of freedom from re-intervention was higher in patients undergoing aortic root replacement, although not reaching a level of statistical significance. Patients who underwent aortic arch treatment showed reduced survival. (4) Conclusions: In the treatment of type A acute aortic dissection, all the surgical strategies adopted were associated with satisfactory long-term survival. In the group of patients in which the aortic root had not been replaced, we observed reduced event-free survival.

P708: CANADIAN AND RUSSIAN EXPERIENCES OF ASCIMINIB IN CHRONIC MYELOID LEUKEMIA (CML) PATIENTS WHO FAILED MULTIPLE LINES OF TYROSINE KINASE INHIBITOR (TKI) THERAPY.

Background: Asciminib (ASC) is a novel, first in class ‘specifically targeting the ABL myristate pocket (STAMP) inhibitor. Recent update of the ASCEMBL phase 3 data showed a superior cumulative incidence of major molecular rate (MMR) of 33.2% with ASC over bosutinib (BOS) at 18.6% by 48 weeks and higher MR4 rate (BCR-ABL1 ≤0.01%) of 14.0% with ASC over 6.6% with BOS at 48 weeks in CML patients (pts) in chronic phase (CP) who have failed at least two lines of TKI therapy. Aims: Canadian and Russian groups individually reported their real-world experiences of ASC therapy under the Managed Access Program in heavily pre-treated CML patients. Methods: Data was collected, updated and merged from 80 CML pts treated with ASC between Nov 2018 - Dec 2021 (n=57 in Russia; n=23 in Canada). Median age was 57 years (range 20-92). The median number of previous TKIs was 4 (range 2-6); Imatinib (n=74, 93%), dasatinib (n=64, 80%), nilotinib (n=58, 73%), bosutinib (n=51, 64%), ponatinib (n=35, 44%), and others (n=13, 16%). Median duration from diagnosis to ASC treatment was 92 mo (months) (range 11-310). 27 (34%) pts had a past history of clinically significant cardiovascular disease or high risk profile for cardiovascular disease. Of the 80 pts, 27 (34%) had a preexisting T315I mutation and 18 (23%) had a non-T315I mutation. Pts failed previous TKI therapy due to A)resistance or suboptimal response (n=59; 74%) and B)intolerance (n=21; 26%). BCR-ABL qPCRs were monitored at each institution. Achievement of MMR and molecular response of 4 log reduction (MR4) was assessed at 6 and 12 mo. Results: With a median of 9 mo of follow-up (range 1-38), MMR was noted in 15/68 (22%) and 14/36 pts (39%) evaluated at 6 and 12 mo, respectively. MR4 was noted in 11/68 (16%) and 9/36 pts (25%) at 6/12 mo. The cumulative incidence of MMR and MR4 was 32.6% (20.9-44.8%) and 15.9% (7.9-26.3%) at 12 mo. The probability of freedom from treatment failure (FTF) at 12 mo was 42.4% (27.6-56.4%), based on the ELN 2013 failure criteria for 2nd line therapy or beyond. In the overall population (n=80), FTF was significantly associated with reason for switch to ASC (p=0.006), and there was a trend toward association of FTF with disease phase (p=0.08) and ponatinib therapy (p=0.12), but not with ABL1 kinase domain mutation (p=0.402), additional cytogenetic abnormality (p=0.908), nor cardiovascular risk profile (p=0.345). When analysis was restricted to the patients in CML-CP (n=65), a median duration of FTF was calculated as 11.6 mo, while the 12 mo FTF rate was 46.8% (28.9-62.8%). The patients previously treated with ponatinib (n=25) showed a 27.7% (8.4-51.4%) FTF rate at 12 mo, which was lower than that in those naïve to ponatinib (n=40), 61.7% (34.9-80.2%; p=0.023). Those switched to ASC for intolerance (n=21) showed higher 12 mo FTF rate of 81.2% (41.5 -95.2%) compared to 29.4% (11.3-50.2%) in those with resistance (n=44; p=0.008). Fifteen pts discontinued ASC due to treatment failure (n=11), progression of disease to blast phase (n=3) or grade 4 thrombocytopenia (n=1). No cardiovascular event was noted. Image:Summary/Conclusion: This combined Canadian and Russian real-world experience of ASC study includes heavily pretreated CML pts including 15 pts in advanced phase. The MMR and MR4 rates were comparable in those in CP, while it was lower in non-CP pts. The 12 mo FTF rate of 42.4% was comparable to the one reported from the ASCEMBL study, 57.7%, considering that this group includes more patients who had heavily pre-treated with advanced disease. *AGT and FK contributed equally as co-first author.

Auryon Laser in Treating Symptomatic Infrainguinal Arterial Disease: 1-Year Outcome.

The Auryon 355-nm laser atherectomy system (AngioDynamics, Inc) showed a low rate of target-lesion revascularization (TLR) at 6-month follow-up in the EX-PAD-03 investigational device exemption study and the Auryon single-center experience (SCE) in treating infrainguinal arteries. In this study, we present the 1-year outcomes of the Auryon SCE study on TLR in all comers at a single center. The Auryon SCE was a retrospective study that evaluated the outcomes of all comers treated with the Auryon laser for infrainguinal arterial disease. There was no TLR seen at 6-month follow-up. We present the TLR rate at 1 year in the same cohort of patients. TLR rates were obtained from medical record review of patients enrolled in the study who had completed office visit follow-up at 1 year. Secondary endpoints included unplanned major amputation and total mortality. Kaplan-Meier survival analysis was performed to estimate the freedom from TLR rate following index procedure. Statistical differences were analyzed for ankle-brachial index (ABI) between baseline and 1 year. A total of 56 patients (65 procedures, 70 lesions) were enrolled. The mean age was 70.9 ± 10 years, with 66.1% males, 48.2% diabetics, and 25% demonstrating limb ischemia. Of the 70 lesions, 31.4% had severe calcification, 38.6% were chronic total occlusions, and 48.6% were de novo disease (in-stent restenosis, 29.6%). Stenting was performed in 24/70 lesions (34.3%), with 11/70 (15.7%) bailout procedures. Embolic filters were used in 26/65 procedures (40%). The majority of treated lesions were femoropopliteal (90.0%); of all procedures, 29.2% had 2 or more prior interventions. Drug-coated balloon usage was 47.1% Lutonix (BD/Bard), 27.1% In.Pact (Boston Scientific), and 1.4% both in all lesions treated. Distal embolization occurred in 1/65 procedures (1.5%). At 1 year, mortality occurred in 3/56 patients (5.4%). Of 65 limbs treated, 2 (3.1%) had major amputation at 1 year. The probability of freedom from TLR was 83.7%. In a realworld cohort of patient with complex disease, the Auryon laser had excellent freedom from TLR at 1 year.

Auryon Laser in Peripheral Arterial Interventions: A Single-Center Experience (Auryon-SCE).

The Auryon 355-nm laser atherectomy system (AngioDynamics, Inc) showed a low rate of target-lesion revascularization (TLR) at 6-month follow-up in the investigational device exemption study. At present, real-world data are not available. In this study, we analyze major adverse events and 6-month outcomes with the Auryon laser system in treating infrainguinal arterial disease in all comers at a single center. Consecutive patients treated with the Auryon laser between September 2017 and March 2021 were retrospectively reviewed from a single operator at a single center. Demographic, procedural, angiographic, and outcome data were extracted from patients' medical records. Descriptive and survival analyses were performed. The study's primary endpoint was the assessment of freedom from TLR at 6-month follow-up. Secondary endpoints included acute procedural results, distal embolization, bailout stenting (dissection type D or higher by National Heart, Lung, and Blood Institute [NHLBI] classification, and/or residual narrowing >30%), unplanned major amputation, death, or vascular complications. A total of 56 patients (65 procedures, 70 lesions) were enrolled. The mean age was 70.9 ± 10 years, 66.1% were males, 48.2% were diabetics, and 25% had limb ischemia. Of the 70 lesions, 31.4% had severe calcification, 38.6% were chronic total occlusions, and 48.6% were de novo disease (in-stent restenosis in 28.6%). The majority of treated vessels were femoropopliteal (88.6%) and 29.2% had 2 or more prior interventions. Mean stenosis was 91.3 ± 9.7% at baseline, 56.0 ± 17.3% post laser, and 11.4 ± 11.2% post final treatment. Lesion length was 117.1 ± 101.2 mm and treated length was 174.0 ± 116.0 mm. Bailout stenting occurred in 11/70 lesions (15.7%). There were no NHLBI type D dissections post laser and 1 type D dissection post laser + percutaneous transluminal angioplasty. A total of 47.1% received Lutonix drug-coated balloons (BD/Bard), 27.1% received In.Pact drug-coated balloons (Boston Scientific), and 1.4% received both. The probability of freedom from TLR per procedure was 95.6% at 6 months. In a real-world cohort of patients with complex disease, the Auryon laser had excellent freedom from TLR at 6 months, although these findings need to be replicated in a randomized trial.

Comparison of the confidence in freedom from infection based on different control programmes between EU member states: STOC free

The STOC free project constructed a generic framework that allows a standardised and harmonised description of different control programmes (CP) for cattle diseases. The STOC free model can be used to determine the confidence of freedom from infection that has been achieved in disease CPs, in support of an ongoing assessment of progress towards output-based standards as outlined in the EU Animal Health Law. With this information, and as required, further CP actions can be taken to mitigate the risks of persistence and (re-)introduction on the probability of freedom from infection. Bovine viral diarrhoea virus (BVDV) was chosen as the case disease because of the diversity in CPs in the six participating countries. A Bayesian hidden Markov model was considered the best modelling method. Detailed BVDV CP information was collected in the participating countries and the key aspects for inclusion in the STOC free model were identified. A first version of STOC free model was developed and tested on simulated data. The risk factors for BVDV infection that needed to be included in the model were defined and default values for these risk factors were quantified. A data collection tool was finalised with which the data for the STOC free model was collected. Subsequently, the developed model was tested and validated using real BVDV CP data from partner countries. Based on the feedback, the model was finalised and the report and corresponding computer code were made publicly available. There were roughly three different BVDV situations that occurred in the partner countries: 1. Endemic situation with a CP operating at herd level, 2. Endemic situation with a CP operating at animal level and 3. BVD free situation. The STOC free model is able to include herd level data only and animal level data has to be aggregated to herd level before the model can be applied. The STOC free model is not applicable for a country that is completely BVDV free given that it needs some infections to estimate its parameters and converge. In the latter situation, a scenario tree model could be a better suited tool, and this was evaluated in the Swedish case study. Further work is needed for generalisation of the method to other diseases and expansion of the method to include socioeconomic aspects of CPs.

The effectiveness of strict low-density lipoprotein cholesterol management in secondary prevention of Japanese patients

Abstract Background In Japanese guidelines, target value of low-density lipoprotein cholesterol (LDL-C) &amp;lt;100mg/dL is recommended as standard management for secondary prevention of coronary artery disease. On the other hand, the guidelines also state that LDL-C targeting &amp;lt;70mg/dL should be considered in high-risk patients. However, the effectiveness of strict LDL-C management in the prevention of long-term coronary event recurrence in Japanese patients remains unclear. Purpose The purpose of the present study was to evaluate whether the strict management of LDL-C targeting &amp;lt;70 mg/dL was effective to prevent recurrence of acute coronary syndrome (ACS) than standard management in patients with previous percutaneous coronary intervention (PCI). Methods From January 2007 to August 2020, we performed coronary angiography in 359 patients with previous PCI who were suspected of having signs of recurrent cardiac ischemia. Patients were stratified into three groups according to achieved LDL-C value; &amp;lt;70mg/dL (n=57), 70 to &amp;lt;100mg/dL (n=135) and ≥100mg/dL (n=167). In addition, patients who had previous ACS and/or diabetes mellitus were defined as high-risk group, and sub-analysis by their achieved LDL-C values was performed in high-risk group and non-high-risk group. Endpoint was recurrence of ACS. Moreover, risk factors associated with recurrent-ACS were examined in patients with LDL-C &amp;lt;100 mg/dL. Results After follow-up (median 6.1 years), 99 patients (28%) had recurrent-ACS. Recurrent-ACS was significantly lower in patients with LDL-C &amp;lt;70mg/dL than LDL-C 70 to &amp;lt;100mg/dL and LDL-C ≥100mg/dL (p&amp;lt;0.01 and p&amp;lt;0.001, respectively). In sub-analysis, high-risk group with LDL-C &amp;lt;70 mg/dL had lower incidence of recurrent-ACS than LDL-C 70 to &amp;lt;100 mg/dL (p=0.03). Similar tendency was found in non-high-risk group (p=0.08). There was no difference of recurrent-ACS between high-risk group and non-high-risk group in patients with LDL-C &amp;lt;70mg/dL (p=0.41). Moreover, in patients with achieved LDL-C &amp;lt;100mg/dL (n=192), multivariate analysis identified that LDL-C (HR: 1.032, p&amp;lt;0.01) and HbA1c (HR: 1.330, p&amp;lt;0.01) were independent predictors of recurrent-ACS. In these patients, whether or not they were in the high-risk group was not a significant predictor (p=0.61). Conclusions Strict management of LDL-C targeting &amp;lt;70 mg/dL should be considered for a wider range of Japanese patients as well as for Westerners to prevent recurrence of ACS in secondary prevention. Funding Acknowledgement Type of funding sources: None. Probability of freedom from ACS

Long-term outcomes of 265,737 patients hospitalised with atrial fibrillation and atrial flutter from 2008 to 2015

Abstract Background Atrial fibrillation/atrial flutter (AF/AFL) hospitalisations are common, however, little is known about the long-term outcomes of these episodes. Objective To examine the incidence of mortality, all-cause and cause-specific re-hospitalisations at up to 8 years after a hospitalisation for AF/AFL. Methods Unique patients hospitalised with a primary diagnosis of AF/AFL from 2008–2015 were identified using nation-wide hospitalisation data from Australia and New Zealand. All-cause mortality was the primary outcome. Secondary endpoints included all-cause and cause-specific re-hospitalisations. Results were reported as incident rate per 100 patient-years. Results We included 265,737 patients (mean age 69.9±13.9y, female 45.2%, elective 28.7%). The median length of stay was 1 day (Interquartile range [IQR] 0–4 days) and the median CHA2DS2-VASc score was 2 (IQR 1–2). During the index hospitalisation, 9,837 (3.7%) patients underwent catheter or surgical ablation and 52,634 (19.8%) underwent cardioversion. During the median follow-up time of 3.4 years (range 0–8.0 years), 53,669 patients died (incident rate of 5.7/100 patient-years) with a survival probability gradually decreasing from 92.8% (95% CI 92.7–92.9%) at 1-year to 65.4% (95% CI 64.9–65.8%) at 8-years post-discharge (Table 1 and Figure 1). All-cause re-hospitalisations occurred in 210,118 patients (incident rate of 22.2/100 patient-years) with a rehospitalisation-free survival probability of 7.1% (95% CI 6.9—7.3%) at the end of follow-up. Unplanned re-hospitalisations occurred more frequently than planned episodes (incident rate of 17.2 vs. 16.6/100 patient-years respectively). AF/AFL accounted for 25.1% of all-cause re-hospitalisations (incident rate of 8.9/100 patient-years) and the probability of freedom from re-hospitalisations for AF/AFL was 55.4% (95% CI 55.0–55.8%) at 8-years. Incident rates of re-hospitalisations for catheter ablation (1.5/100 patient-years), stroke (1.6/100 patient-years), heart failure (2.7/100 patient-years), and acute myocardial infarction (1.0/100 patient-years) were low. In subgroup analyses, worse survival was observed in female patients, older age groups, patients with comorbid heart failure, hypertension, diabetes, and those who did not undergo ablation during the index hospitalisation. Conclusion Nearly two-thirds of patients were surviving by 8-years following an AF/AFL hospitalisation with a low rate of re-hospitalisations for stroke, heart failure, and myocardial infarction. However, re-hospitalisations for recurrent atrial arrhythmia were common. Efforts to reduce re-hospitalisations, especially unplanned encounters, are required to improve patient outcomes. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): National Heart Foundation of Australia

Pulmonary artery augmentation using decellularized equine pericardium (Matrix Patch™): initial single-centre experience.

The aim of this study was to report our initial experience when using Matrix Patch™ a cell-free equine-derived pericardium for the augmentation of branch pulmonary arteries (PAs) in children. Between September 2016 and September 2019, Matrix Patch was used for the augmentation of branch PAs in 96 patients and implanted in 147 separate locations. The median age at implantation was 3.2 years (interquartile range: 0.9-8.4), and 33% of patients were infants. The patch was used mainly in redo surgeries (89.6%). Intra-procedural feasibility and reinterventions were analysed. Primary end points were death or patch-related reoperation/stent implantation. Explanted patches were stained for recellularization/calcification, or to reveal proliferation/inflammation. A total of 81 patients, who received patches in 119 separate locations, were followed within a median of 20 months (interquartile range: 10.2-30.2). Patients with early reoperation/stent implantation were excluded from follow-up. No patch-related death was noted. Survival at last follow-up was 88% (95% CI: 78.8-93.7%). Overall probability of freedom from reoperation/stent implantation per location, 12 and 24 months after initial surgery was 85.8% (95% CI: 76.2-91.7%) and 78.7 (95% CI: 65.9-87.2%), respectively. At 20 months, superficial proliferation with discrete macrophage activity was seen in explants; however, no signs of calcification are observed. The initial experience with the Matrix Patch in PAs showed comparable results to other xenogeneic patch materials. Long-term follow-up data are needed to prove the desired durability of the patch in different locations.

Reliability and longevity of implantable defibrillators

PurposeWe hypothesized that data in manufacturers’ product performance reports (PPRs) can provide clinically valuable ICD and cardiac resynchronization defibrillator (CRT-D) reliability and longevity information.MethodsData were obtained from 2019 PPRs. Kaplan-Meier (K-M) probabilities of freedom from malfunction, normal battery depletion (NBD), and NBD + malfunction were calculated for ICD and CRT-D pulse generators (PGs) with LiMnO2 or LiSVO/CFx batteries marketed in the USA from 2010 to 2019 and compared using the log-rank test. Malfunctions (MAL) included PGs that were found outside specifications.ResultsStudy population included 1,149,803 ICD and CRT-D PGs: Abbott (ABT; 35.1%), Biotronik (BIO; 4.6%), Boston Scientific (BSC; 23.5%), and Medtronic (MDT; 36.9%). Significant differences in reliability (p < 0.001), defined by freedom from MAL, were found between manufacturers; the majority of 6808 MAL occurred in ABT devices (n = 4045; 59.4%), followed by BSC (n = 2384; 35.0%), MDT (n = 338;5.0%), and BIO (n = 41; 0.6%). Battery failure (n = 890; 57.9%) was the most common cause of MAL compromising therapy; analysis of unique ABT battery MAL–indicated problem appeared a year prior to advisory. Significant differences (p < 0.001) in battery longevity, as defined by freedom from NBD, were found between manufacturers. Overall performance (freedom from NBD + MAL) favored BSC for CRT-D PGs and MDT and BIO for ICDs. BSC subcutaneous ICD reliability was inferior to its transvenous ICD (p < 0.001).ConclusionPPRs contain valuable data that can be aggregated and analyzed to inform physicians. Differences in product reliability exist between manufacturers. Battery longevity has improved, but MAL have significantly impacted performance. PPR data may be useful for assessing product problems and new technology.