Device-device communication stability of leadless anti-tachycardia pacemaker and subcutaneous implantable cardioverter defibrillator over 18 months

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
F.V.Y Tjong ◽  
R.E Knops ◽  
B Swackhamer ◽  
B Koop ◽  
B Soltis ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Linear Regression Analysis ◽  
Funding Source ◽  
Private Company ◽  
Leadless Pacemaker ◽  
Significant Difference ◽  
System Migration ◽  
Termination Time ◽  
Time Point

Abstract Background A novel modular cardiac rhythm management (mCRM) therapy approach is evaluated in this study: the performance of an anti-tachycardia pacing enabled leadless pacemaker (LP) commanded by a subcutaneous-ICD (S-ICD) via wireless, intra-body, device-device communication (DDC). Objectives To investigate long-term DDC performance of linked S-ICD to LP (mCRM System) and factors that impact DDC performance. Methods The mCRM System was implanted in 37 canine subjects: 33 with an S-ICD and an LP; 4 with an S-ICD and 2 LPs. The S-ICD was implanted using a Parsonnet pouch in the first 8 subjects. Communication thresholds were measured in three postures up to 18 months. Percent tissue encapsulation of the LP was measured at necropsy and ranged from 6% to 100% (mean: 62%). S-ICD system migration was evaluated radiographically at implant vs. at necropsy in two planes (anterior-posterior and left lateral) and evaluated 0–3 scale: none, minimal, moderate, significant. Communication thresholds were evaluated at 0 vs. 3 days using a t-test and 3 days through 18 months using a linear regression analysis. A repeated measures generalized linear model (GLM) was used to evaluate if test posture, percent tissue encapsulation of the LP, Parsonnet pouch use, or S-ICD system migration (no/ minimal migration vs. moderate/significant migration) were significant predictors of DDC performance at the subject's termination time point. Results DDC was successful for each tested posture and time point for all subjects (n=37), with 355 tests in Left Lateral (LL), 371 tests in Dorsal (D), and 355 tests in Right Lateral (RL). Follow up data are available up to 18 months for 19 subjects at the time of this abstract; additional follow-up data will be added to the analysis for presentation. Communication thresholds decreased between 0 days and 3 days (LL P<0.01, D P<0.01, RL P<0.05) and did not change significantly from 3 days through 18 months (LL P=0.90, D P=0.83, RL P=0.83). The GLM showed that there is no significant difference in communication thresholds for test posture (P=0.24 LL vs. D, P=0.24 RL vs. D), percent tissue encapsulation of the LP (P=0.63), Parsonnet pouch use (P=0.65), or S-ICD system migration (P=0.95). Conclusion Longitudinal studies demonstrate low and stable communication thresholds of a novel mCRM system over time for all three tested postures, regardless of factors such as LP encapsulation, Parsonnet pouch use, or S-ICD system migration. Device Communication Threshold Stability Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Boston Scientific

scholarly journals Silent cerebral embolisation during TAVI: evolution, predictors and neurocognitive effects

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M De Carlo ◽  
R Liga ◽  
G.M Migaleddu ◽  
M Scatturin ◽  
C Spaccarotella ◽  
...  
Keyword(s):  
White Matter ◽  
Median Number ◽  
Funding Source ◽  
Private Company ◽  
Diffuse White Matter ◽  
Transcatheter Aortic Valve ◽  
Age Related ◽  
Cerebral Mri ◽  
Neurocognitive Evaluation

Abstract Background Most patients undergoing transcatheter aortic valve implantation (TAVI) develop silent cerebral ischemic lesions (SCIL) detectable at magnetic resonance imaging (MRI). The natural history and clinical relevance of SCIL are not well established. We aimed to assess the characteristics, predictors, evolution, and neurocognitive effects of SCIL. Methods Cerebral MRI was performed within 7 days before TAVI to assess baseline status and age-related white matter changes (ARWMC) score. MRI was repeated postoperatively to assess the occurrence, location, number and dimensions of SCIL. Patients developing SCIL underwent a third MRI at 3–5 months follow-up. A neurocognitive evaluation was performed before TAVI, at discharge and at 3-month follow-up. Results Of the 117 patients enrolled, 96 underwent a postprocedural MRI; SCIL were observed in 76% of patients, distributed in all vascular territories, with a median number of 2 lesions, median diameter 4.5 mm, and median total volume 140 mm3. Independent predictors of SCIL occurrence were a higher baseline ARWMC score and the use of self-expanding or mechanically-expanded bioprostheses. Among 47 patients who underwent follow-up MRI, only 26.7% of postprocedural SCIL evolved into a gliotic scar. SCIL occurrence was associated with a more pronounced transient neurocognitive decline early after TAVI and with a lower recovery at follow-up. Conclusions SCIL occur in the vast majority of patients undergoing TAVR and are predicted by a more diffuse white matter damage at baseline and by the use of non-balloon-expandable prostheses. Although most SCIL disappear within months, their occurrence has a limited but significant impact on neurocognitive function. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): unrestricted grants from Edwards Lifesciences SA, Nyon, Switzerland, and from Medtronic Italia SpA, Milan, Italy

HIV may indirectly accelerate coronary artery disease through enhancing the effects of conventional and non-conventional cardiovascular risk factors

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Kolossvary ◽  
E.K Fishman ◽  
G Gerstenblith ◽  
D.A Bluemke ◽  
R.N Mandler ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cardiovascular Risk ◽  
Hiv Infection ◽  
Cardiovascular Risk Factors ◽  
Agatston Score ◽  
Funding Source ◽  
Significant Difference ◽  
Ascvd Risk ◽  
Artery Disease

Abstract Background/Introduction Cross-sectional studies are inconsistent on the potential independent adverse effects of human immunodeficiency virus (HIV)-infection on coronary artery disease (CAD). Furthermore, there is no information on the potential effects of HIV-infection on plaque volumes. Also, only the independent effects of HIV-infection on CAD have been investigated. Purpose In a prospective longitudinal observational cohort, we wished to assess whether HIV-infection accelerates CAD independently, or by acting in synergistic fashion with conventional and nonconventional cardiovascular risk factors to accelerate disease progression as assessed by clinical and volumetric parameters of CAD on coronary CT angiography (CCTA). Methods Overall, 300 asymptomatic individuals without cardiovascular symptoms but with CCTA-confirmed coronary plaques (210 males, age: 48.0±7.2 years) with or without HIV (226 HIV-infected) prospectively underwent CCTA at two time points (mean follow-up: 4.0±2.3 years). Agatston-score, number of coronary plaques, segment stenosis score were calculated, and we also segmented the coronary plaques to enumerate total, noncalcified (−100–350HU) and calcified (≥351HU) plaque volumes. Linear mixed models were used to assess the effects of HIV-infection, atherosclerotic cardiovascular disease (ASCVD) risk, years of cocaine use and high-sensitivity C-reactive protein on CCTA markers of CAD. Results In univariate analysis, there was no significant difference in CAD characteristics between HIV-infected and -uninfected, neither at baseline nor at follow-up (p>0.05 for all). Furthermore, there was no significant difference in annual progression rates between the two groups (p>0.05 for all). By multivariate analysis, HIV was not associated with any CAD parameter (p>0.05 for all). However, among HIV-infected individuals, each year of cocaine use significantly increased all CAD parameters (p<0.05 for all), while ASCVD risk score was significantly associated with CAD parameters except for Agatston-score (p<0.05). These associations were only present among HIV-infected individuals. Conclusion(s) Instead of directly worsening CAD, HIV may promote CAD through increased susceptibility to conventional and nonconventional cardiovascular risk factors. Therefore, aggressive management of both conventional and nonconventional cardiovascular risk factors is needed to reduce cardiovascular burden of HIV-infection. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Institutes of Health, National Institute on Drug Abuse

scholarly journals Cytotoxicity assessment of different doses of ozonated water on dental pulp cells

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ferdiye Küçük ◽  
Sibel Yıldırım ◽  
Serap Çetiner
Keyword(s):  
Cell Viability ◽  
Repeated Measures ◽  
Dental Pulp ◽  
Control Group ◽  
Dental Pulp Cells ◽  
Time Points ◽  
Significant Difference ◽  
Pulp Cells ◽  
Time Point ◽  
Ozonated Water

Abstract Background The purpose of this study was to assess the cytotoxicity of various concentrations of ozonated water (OW) on human primary dental pulp cells. Methods Human primary dental pulp cells were isolated from exfoliated primary canine teeth of an 11-year-old patient with good systemic and oral health. Afterwards, cells were divided into 6 experimental groups; four groups of OW in concentrations of 2 mg/L, 4 mg/L, 8 mg/L, and 16 mg/L, untreated control group, and cell culture without cells. Cytotoxicity was evaluated after exposure for 5-min exposure using Mosmann’s Tetrazolium Toxicity (MTT) assay at 0 h and 48 h time points. Data were analyzed using a repeated measures analysis of variance and Post-hoc tests were performed using Bonferroni correction for multiple comparisons. Results All experimental groups showed proliferation at 0 h time point. However, all groups also experienced a decrease in overtime at 48 h time point (p < 0.05). At both time points 2 mg/L OW showed the highest cell viability as well as proliferation. At 0 h time point, the increase in cell viability for all experimental groups was found statistically significant when compared to positive control group (p < 0.05). At 48 h time point, although 8 mg/L and 16 mg/L OW showed statistically significant reduction in compare to 0 h time point, 2 mg/L and 4 mg/L OW groups didn’t experience any statistically significant difference (p < 0.05). Conclusion Considering our findings, due to ozonated water's induced a higher proliferation rate of dental pulp cells, indicating their biocompatibility and a possible adjuvant on irrigating agent in regenerative endodontic procedures.

Benefits of tafamidis in patients with advanced transthyretin amyloid cardiomyopathy

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
C Rapezzi ◽  
A.V Kristen ◽  
B Gundapaneni ◽  
M.B Sultan ◽  
M Hanna
Keyword(s):  
Disease Severity ◽  
Nyha Class ◽  
Funding Source ◽  
Class Iii ◽  
Private Company ◽  
Risk Of Death ◽  
6Mwt Distance ◽  
All Cause Mortality ◽  
Amyloid Cardiomyopathy

Abstract Background In the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT), tafamidis was shown to be an effective treatment for patients with transthyretin amyloid cardiomyopathy (ATTR-CM). Further assessment of the efficacy of tafamidis in patients with more advanced ATTR-CM would aid treatment decisions. Purpose To characterize the benefits of tafamidis in patients with advanced ATTR-CM. Methods In ATTR-ACT, ATTR-CM patients were randomized to tafamidis (n=264) or placebo (n=177) for 30 months. Efficacy outcomes included all-cause mortality and frequency of cardiovascular (CV)-related hospitalisations. Key secondary endpoints were change from baseline to Month 30 in 6MWT distance and KCCQ-OS score. Efficacy assessments in NYHA Class III patients at baseline (n=141) were a pre-specified analysis. In a post-hoc analysis, mortality and CV-related hospitalizations were assessed in all patients grouped into quartiles of increasing disease severity based on 6MWT distance at baseline. Longer-term all-cause mortality (as of 1 Aug 2019) was assessed in NYHA Class III patients utilizing data from ATTR-ACT patients who enrolled in a long-term, extension study (LTE) and continued treatment with higher dose tafamidis (n=55; median treatment duration 51.6 months); or, if previously treated with placebo, started tafamidis treatment (placebo/tafamidis; n=63 [50.1 months]). Results In advanced ATTR-CM patients (NYHA Class III), tafamidis reduced the risk of death (HR [95% CI] 0.837, [0.541, 1.295], P=0.4253), and the decline in 6MWT distance (LS mean [SE], 31.6 (22.1) m; P=0.1526) and KCCQ-OS score (LS mean [SE], 13.1 (5.0); P=0.0090), vs placebo. Paradoxically, there was a higher frequency of CV-related hospitalizations with tafamidis (RR [95% CI] vs placebo, 1.411 [1.048, 1.900]). In all patients by 6MWT quartile, CV-related hospitalizations/year with tafamidis and placebo increased with disease severity, with the exception that placebo-treated patients in the highest severity quartile had fewer CV-related hospitalisations (0.73) than those in the third quartile (0.92). Mortality with tafamidis and placebo increased, and was greater with placebo, in every quartile (Figure). Survival (NYHA Class III patients in ATTR-ACT and LTE) was improved with high dose tafamidis with longer term follow-up (HR vs placebo/tafamidis [95% CI], 0.6569 [0.4175, 1.0336]; P=0.0692). Conclusions These analyses, including longer-term follow-up, demonstrate that patients with advanced ATTR-CM benefit from tafamidis. The decrease in CV-related hospitalisations in more severe patients treated with placebo suggests that the comparatively greater hospitalisation frequency in NYHA Class III patients treated with tafamidis is a consequence of their lower mortality rate. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This study was sponsored by Pfizer

Artificial intelligence-guided image acquisition on patients with implanted electrophysiological devices: results from a pivotal prospective multi-center clinical trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S Surette ◽  
A Narang ◽  
R Bae ◽  
H Hong ◽  
Y Thomas ◽  
...  
Keyword(s):  
Qualitative Assessment ◽  
Funding Source ◽  
Software Performance ◽  
Private Company ◽  
Diagnostic Quality ◽  
Icd Leads ◽  
Significant Difference ◽  
Level 3 ◽  
And Function ◽  
The Impact

Abstract Background A novel, recently FDA-authorized software uses deep learning (DL) to provide prescriptive transthoracic echocardiography (TTE) guidance, allowing novices to acquire standard TTE views. The DL model was trained by &gt;5,000,000 observations of the impact of probe motion on image orientation/quality. This study evaluated whether novice-acquired TTE images guided by this software were of diagnostic quality in patients with and without implanted electrophysiological (EP) devices, focusing on RV size and function, which were thought to be sensitive to EP devices. Some aspects of the study have previously been presented. Methods 240 patients (61±16 years old, 58% male, 33% BMI &gt;30 kg/m2, 91% with cardiac pathology) were recruited. 8 nurses without echo experience each acquired 10 view TTEs in 30 patients guided by the software. 235 of the patients were also scanned by a trained sonographer without assistance from the software. 5 Level 3 echocardiographers independently assessed the diagnostic quality of the TTEs acquired by the nurses and sonographers to evaluate the effect of EP devices on DL software performance. Results Nurses using the AI-guided acquisition software acquired TTEs of sufficient quality to make qualitative assessments of right ventricular (RV) size and function in greater than 80% of cases for patients with and without implanted EP devices (Table). There was no significant difference between nurse- and sonographer-acquired scans. Conclusion These results indicate that new DL software can guide novices to obtain TTEs that enable qualitative assessment of RV size even in the presence of implanted EP devices. The results of the comparison to sonographer-acquired exams indicate the software performance is robust to presence of pacemaker/ICD leads visible in the images (Figure). Nurse-acquired TTE with visible ICD lead Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Caption Health, Inc.

scholarly journals RNAi inhibition of angiopoietin-like protein 3 (ANGPTL3) with ARO-ANG3 mimics the lipid and lipoprotein profile of familial combined hypolipidemia

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
G.F Watts ◽  
C Schwabe ◽  
R Scott ◽  
P Gladding ◽  
D Sullivan ◽  
...  
Keyword(s):  
Adverse Events ◽  
Dose Response ◽  
Minimal Change ◽  
Funding Source ◽  
Private Company ◽  
Good Tolerability ◽  
Duration Of Action ◽  
Mixed Dyslipidemia ◽  
Genetic Deficiency

Abstract Background Elevated LDL-C and triglyceride rich lipoproteins (TRLs) are independent risk factors for cardiovascular disease (CVD). Genetic deficiency of angiopoietin-like protein 3 (ANGPTL3) is associated with reduced circulating levels of LDL-C, triglycerides (TGs), VLDL-C, HDL-C and reduced CVD risk, with no described adverse phenotype. ARO-ANG3 is a RNA interference drug designed to silence expression of ANGPTL3. Single doses of ARO-ANG3 have been shown to reduce ANGPTL3, TGs, VLDL-C and LDL-C in healthy volunteers (HVs, AHA 2019). We report the effects of multiple doses of ARO-ANG3 in HVs with a focus on the duration of action. Methods ARO-ANG3 was administered subcutaneously to HVs on days 1 and 29 at doses of 100, 200 or 300 mg (n=4 per group). Measured parameters included ANGPTL3, LDL-C, TGs, VLDL-C and HDL-C. Follow up is ongoing. Results All HVs have received both doses and follow-up is currently through week 16 (12 weeks after second dose). Mean nadir for ANGPTL3 levels occurred 2 weeks after the second dose (−83–93%) with minimal change for 200 and 300 mg but 16% recovery for 100 mg at week 16. Mean TGs and VLDL-C reached nadir earlier (3 wks, −61–65%) without apparent dose response and minimal change for any dose at wk 16. LDL-C nadir occurred 4–6 wks after the second dose (−45–54%), again with minimal evidence for dose response or change through wk 16. HDL-C was reduced 14–37% at wk 16. ARO-ANG3 was well tolerated without serious or severe adverse events or dropouts related to drug. The most common adverse events have been headache and upper respiratory infections. Conclusions Genetic deficiency of ANGPTL3 is a cause of familial combined hypolipemia and is associated with a decreased risk of CVD. Using RNAi to selectively suppress ANGPTL3 production reproduces these genetic effects with a duration of at least 12 weeks following a second dose and with good tolerability over 16 wks. ANGPTL3 inhibition results in lowering of LDL-C and TRLs which may confer protection against CVD in patients with atherogenic mixed dyslipidemia. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Arrowhead Pharmaceuticals

Impact of cardiac rehabilitation on 3 year outcomes amongst patients after acute coronary syndrome: (ACS) SNAPSHOT ACS follow-up study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Redfern ◽  
K Hyun ◽  
D Brieger ◽  
D Chew ◽  
J French ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Cardiac Rehabilitation ◽  
Data Linkage ◽  
Research Network ◽  
Funding Source ◽  
Cardiovascular Research ◽  
Coronary Syndrome ◽  
Follow Up Study ◽  
Significant Difference

Abstract Background Cardiovascular disease is the leading cause of disease burden globally. With advancements in medical and surgical care more people are surviving initial acute coronary syndrome (ACS) and are in need of secondary prevention and cardiac rehabilitation (CR). Increasing availability of high quality individual-level data linkage provides robust estimates of outcomes long-term. Purpose To compare 3 year outcomes amongst ACS survivors who did and did not participate in Australian CR programs. Methods SNAPSHOT ACS follow-up study included 1806 patients admitted to 232 hospitals who were followed-up by data linkage (cross-jurisdictional morbidity, national death index, Pharmaceutical Benefit Schedule) at 6 and 36 months to compare those who did/not attend CR. Results In total, the cohort had a mean age of 65.8 (13.4) years, 60% were male, only 25% (461/1806) attended CR. During index admission, attendees were more likely to have had PCI (39% v 14%, p&lt;0.001), CABG (11% v 2%, p&lt;0.001) and a diagnosis of STEMI (21% v 5%, p&lt;0.001) than those who did not attend. However, there was no significant difference between CR attendees/non-attendees for risk factors (LDL-cholesterol, smoking, obesity). Only 19% of eligible women attended CR compared to 30% of men (p&lt;0.001). At 36 months, there were fewer deaths amongst CR attendees (19/461, 4.1%) than non-attendees (116/1345, 8.6%) (p=0.001). CR attendees were more likely to have repeat ACS, PCI, CABG at both 6 and 36 months (Table). At 36 months, CR attendees were more likely to have been prescribed antiplatelets (78% v 53%, p&lt;0.001), statins (91% 73%, p&lt;0.001), beta-blockers (11% v 13%, p=0.002) and ACEI/ARBs (72% v 61%, p&lt;0.001) than non-attendees. Conclusions Amongst Australian ACS survivors, participation in CR was associated with less likelihood of death and increased prescription of pharmacotherapy. However, attendance at CR was associated with higher rates of repeat ACS and revascularisation. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): New South Wales Cardiovascular Research Network, National Heart Foundation

The effect of displacement of the esophagus by transoesophageal echocardiography probe in cryoablation of atiral fibrillation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Y Sun ◽  
X.M Yin ◽  
L.J Gao ◽  
X.J Xiao ◽  
X.H Yu ◽  
...  
Keyword(s):  
Lower Risk ◽  
Transoesophageal Echocardiography ◽  
The Other ◽  
Esophageal Injury ◽  
Funding Source ◽  
Success Rates ◽  
Procedure Time ◽  
Mechanical Displacement ◽  
Significant Difference

Abstract Background Esophageal injury caused by cryoballoon-based PVI is common. Cryoablation guided by transoesophageal echocardiography (TEE) for occlusion of the pulmonary vein (PV) is safe and effective. Objective To investigate the protective effect of mechanical displacement of the esophagus by TEE probe in cryoablation of atiral fibrillation. Methods Fifty patients with paroxysmal AF (PAF) were enrolled in the present study. 25 patients underwent cryoablation without TEE (non-TEE group) and the other 25 underwent with TEE (TEE group) for PV occlusion guidance and displacement of the esophagus. In the TEE group during the procedure, TEE was used to guide the movement of the balloon to achieve PV occlusion. And before freezing, the probe of the TEE was moved to displace the esophagus away from the PV being freezed in order to reduce the risk of cryoinjury. All patients underwent esophagogastroscopy within 2 days of the procedure. The patients were followed up in our center at regularly scheduled visits every 2 months. Results There was no significant difference between the TEE group and non-TEE group in regard to the procedure time. The fluoroscopy time in the TEE group was less compared to the non-TEE group (4.1±3.3 min vs. 16.6±6.9 min, P&lt;0.05), and the amount of contrast agent in the TEE group was less than the non-TEE group (4.7±5.7ml vs. 17.9±3.4 ml, P&lt;0.05). The incidence of esophageal injury was significantly lower in TEE group compared with non-TEE group (0 vs. 20%, P&lt;0.05). At a mean of 14.0 months follow-up, success rates were similar between the TEE group and non-TEE group (80.0% vs. 84.0%, P=0.80). Conclusion Cryoablation of AF with TEE for protecting the esophagus from cryoinjury is safe and effective. Lower risk of esophageal injury can be achieved with the help of TEE probe movement for mechanical displacement of the esophagus during freezing. Funding Acknowledgement Type of funding source: None

Baseline characteristics and follow-up outcomes in routine clinical practice patients categorised by renal function in the ETNA-AF-Europe registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R De Caterina ◽  
M Gwechenberger ◽  
A Bakhai ◽  
P Monteiro ◽  
P Kelly ◽  
...  
Keyword(s):  
Renal Function ◽  
Total Mortality ◽  
Haemorrhagic Stroke ◽  
Risk Scores ◽  
Funding Source ◽  
Private Company ◽  
Group I ◽  
Baseline Characteristics ◽  
Event Rates

Abstract Background Edoxaban is an oral factor Xa inhibitor anticoagulant with 50% renal clearance, and proven efficacy and safety in patients (pts) with atrial fibrillation (AF). The post-authorisation, observational, ETNA-AF-Europe registry (NCT02944019) assessed the risks and benefits of edoxaban in pts with AF from 10 European countries. Purpose Evaluate baseline characteristics and event rates in pts categorised by creatinine clearance (CrCl) at 1-year follow-up of the ETNA-AF-Europe registry. Methods In this analysis, pts were divided into three groups according to CrCl: ≤50 ml/min (I), 50–80 mL/min (II) and ≥80 mL/min (III) (calculated using Cockcroft-Gault). Outcomes were descriptively analysed. Results Pts with the lowest CrCl (Group I) were mostly females, and had a higher mean age, lower body weight, higher stroke and bleeding risk scores and were considered more frail than those with higher CrCl (Groups II and III) (Table). Group I experienced higher rates of stroke or SEE, major or CRNM bleeding, cardiovascular death, and had a higher total mortality (Figure). Rates of intracranial haemorrhage (ICH) and haemorrhagic stroke (intracerebral and subarachnoid haemorrhage) were low and similar in pts across the range of CrCl. Conclusions Those with lower CrCl had more comorbidities and higher event rates than those with higher CrCl, with the exception of ICH and haemorrhagic stroke. A steep rise in the proportion of pts perceived as frail and in overall mortality in the lowest renal function tertile, raises the question whether low renal function is a determinant or a correlate of mortality. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Daiichi Sankyo Europe GmbH, Munich, Germany

scholarly journals Minimum 3.5-year outcomes of operative treatment for Achilles tendon partial tears in the midportion and retrocalcaneal area

2020 ◽  
Author(s):  
Heinz Lohrer
Keyword(s):  
Achilles Tendon ◽  
Repeated Measures ◽  
Treatment Strategies ◽  
Systematic Effect ◽  
Partial Tear ◽  
Partial Tears ◽  
Significant Difference ◽  
Respective Treatment ◽  
Retrocalcaneal Bursa

Abstract Background: Achilles tendon partial tears are not easy to diagnose and to manage. Most frequently, they are located in the midportion and insertional area. These entities result from different pathologic pathways and different treatment strategies are applied. The outcome is rarely investigated. Methods: This study includes patients who underwent surgery for partial tears in the midportion or retrocalcaneal Achilles tendon area between the years 2009 and 2015 by a single surgeon. Patients were prospectively assessed preoperatively and 3, 6, and 12 months postoperatively, using the VISA-A-G questionnaire. The final retrospective follow-up was performed after a minimum of 3.5 years postoperatively. Forty-eight Achilles tendon partial tears at the level of the retrocalcaneal bursa (impingement lesions) and 27 midportion Achilles tendon partial tears were identified. After applying rigorous exclusion criteria, 21 and 16 cases, respectively, remained for the final follow-up. Results were analysed by inferential and descriptive statistics.Results: The VISA-A-G outcome scores improved significantly from preoperative to six months, 12 months, and final postoperative assessment. Preoperatively, the average VISA-A-G score was 42.1 (range, 18-73) for patients operated for Achilles tendon partial tears at the level of the retrocalcaneal bursa and 44.6 (range, 10-73) for the midportion Achilles tendon partial tear group, respectively. At final follow-up 88.8 (range, 15 to 100) and 96.9 (range, 71 to 100) were scored in the respective treatment groups. A repeated measures ANOVA determined that mean performance levels showed a statistically significant difference between measurements (p < 0.001). There was no systematic effect found between groups (p = 0.836).Conclusions: In Achilles tendon partial tears recalcitrant to conservative treatment, operative intervention is highly successful in most cases, irrespective of the level of the injury. Results were statistically equal when comparing the midportion and retrocalcaneal Achilles tendon partial tear groups. Trial registration: DRKS, DRKS00014266. Registered 06 April 2018. 'Retrospectively registered', https://www.drks.de/drks_web/navigate.do?navigationId=results .

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