scholarly journals Superior Improvements in Knee Pain and Function with a Novel Synthetic Medial Meniscus Replacement Implant Compared to Non-surgical Care in Subjects with Knee Pain Following Partial Meniscectomy: Two-year Results from Two Prospective US Clinical Trials

2021 ◽  
Vol 9 (7_suppl4) ◽  
pp. 2325967121S0020
Author(s):  
Elliott Hershman ◽  
Brian McKeon ◽  
Christopher Kaeding ◽  
Richard Edelson ◽  
Jonathan Greenleaf ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Knee Pain ◽  
Medial Meniscus ◽  
Surgical Care ◽  
Partial Meniscectomy ◽  
Control Group ◽  
Patient Reported ◽  
The Difference ◽  
And Function

Objectives: Arthroscopic partial meniscectomy (APM) is the most common surgical treatment for symptomatic, irreparable meniscal tears that do not improve with non-surgical care. For many patients, APM is associated with improvements in knee pain and function, but a subset of patients reports persistent or recurrent knee pain 1-2 years after APM surgery. Current treatment options for post-APM knee pain are limited, especially for patients considered too young for knee replacement. The polymeric medial meniscus implant mimics the biomechanical function of the natural medial meniscus and is intended to provide relief from pain and improved function in subjects with knee pain following APM. Two FDA-regulated clinical trials were conducted in the United States and pooled for analysis, to assess superiority of a synthetic medial meniscus implant to non-surgical care in treating persistent or recurrent knee pain following previous partial meniscectomy. The hypothesis was that the meniscus implant is superior to non-surgical care for improvements in composite measures of knee-related pain, function, and quality of life at 2 years of follow-up. Methods: 242 patients (176 investigational, 66 control) were treated in 2 prospective, concurrent clinical trials in the U.S.: a randomized controlled superiority trial (RCT) comparing the medial meniscus implant to non-surgical care (control) and a single-arm, implant-only trial. Eligible subjects had persistent knee pain and one or more previous partial meniscectomies at least 6 months before trial entry. Treated subjects returned for follow-up visits at 1.5 months, 6 months, 1 year, and 2 years. Patient-reported knee pain, function, and quality of life were assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS). The primary patient-reported outcomes were 2 KOOS subscales: KOOS Pain and KOOS Overall. KOOS success was defined as subjects who achieved either (1) KOOS Pain ≥86.1 at 2 years and KOOS Overall ≥86.2 at 2 years or (2) a ≥20-point improvement from baseline to 2 years in KOOS Pain and KOOS Overall, with KOOS Pain ≥40 at 2 years. Treatment cessation was defined as any subject who discontinued the per-protocol treatment by permanent implant removal (implant group) or any surgical procedure on the index knee (control group). Implant subjects who underwent subsequent surgical procedures on index knees (e.g. implant exchange) remained in the trial. The two treatment groups were well-matched, except for baseline KOOS Sports and Recreation. Statistical analyses adjusted for high vs low baseline KOOS Sports and Recreation using 2-factor analysis of variance (ANOVA) for continuous variables and 2x2 logistic regression for dichotomous variables. Results: Sixteen subjects (6.6%; 14 control, 2 implant) were lost to follow-up or withdrew from the study over 2 years. The magnitude of improvement from baseline to 2 years was significantly greater in the implant group compared to control for 5 of 6 KOOS subscales (Figure 1), including the primary outcomes of KOOS Overall and KOOS Pain (Figure 1A,B). The proportion of subjects who achieved KOOS success was significantly higher in the implant group (63.4%) than the control group (27.9%), which remained true with or without the adjustment for baseline KOOS Sports and Recreation ( P<.0001 in each case). Treatment cessation through 2 years was less frequent in the implant group (10.5%) compared to the control group (17.3%), but the difference was not statistically significant ( P=.19). Conclusions: Two-year results from 2 prospective, concurrent, US clinical trials demonstrate that the synthetic meniscus implant provides superior relief from post-APM knee pain when compared to treatment with non-surgical care alone. In addition, the magnitude of change from baseline to 2 years in the primary patient-reported outcomes and the rate of KOOS success significantly favored the implant group compared to the control group. Subjects in the implant group tended to discontinue treatment at a lower rate compared to subjects in the control group, but the difference was not statistically significant. Subjects treated with the implant who underwent a device exchange or repositioning procedure were able to continue treatment therapy with the medial meniscus implant. Overall, the implant group experienced superior improvements and outcomes at 2 years compared to subjects receiving non-surgical care alone.

scholarly journals Treatment of post-meniscectomy knee symptoms with medial meniscus replacement results in greater pain reduction and functional improvement than non-surgical care

2021 ◽  
Author(s):  
Kenneth R. Zaslav ◽  
Jack Farr ◽  
Richard Alfred ◽  
R. Maxwell Alley ◽  
Michael Dyle ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Knee Pain ◽  
Medial Meniscus ◽  
Surgical Care ◽  
Partial Meniscectomy ◽  
Treatment Cessation ◽  
Patient Reported ◽  
And Function

Abstract Purpose Partial meniscectomy is a common orthopedic procedure intended to improve knee pain and function in patients with irreparable meniscal tears. However, 6–25% of partial meniscectomy patients experience persistent knee pain after surgery. In this randomized controlled trial (RCT) involving subjects with knee pain following partial meniscectomy, it was hypothesized that treatment with a synthetic medial meniscus replacement (MMR) implant provides significantly greater improvements in knee pain and function compared to non-surgical care alone. Methods In this prospective, multicenter RCT, subjects with persistent knee pain following one or more previous partial meniscectomies were randomized to receive either MMR or non-surgical care. This analysis evaluated the 1-year outcomes of this 2-year clinical trial. Patient-reported knee pain, function, and quality of life were measured using nine separate patient-reported outcomes. The primary outcomes were the pain subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS) and the average of all five KOOS subscales (KOOS Overall). Treatment cessation was defined as permanent device removal in the MMR group and any surgical procedure to the index knee in the non-surgical care group. Results Treated subjects had a median age of 52 years old (range 30–69 years) and one or more previous partial meniscectomies at a median of 34 months (range 5–430 months) before trial entry. Among 127 subjects treated with either MMR (n = 61) or non-surgical care (n = 66), 11 withdrew from the trial or were lost to follow-up (MMR, n = 0; non-surgical care, n = 11). The magnitude of improvement from baseline to 1 year was significantly greater in subjects who received MMR in both primary outcomes of KOOS Pain (P = 0.013) and KOOS Overall (P = 0.027). Treatment cessation was reported in 14.5% of non-surgical care subjects and only 4.9% of MMR subjects (n.s.). Conclusion Treatment with the synthetic MMR implant resulted in significantly greater improvements in knee pain, function, and quality of life at 1 year of follow-up compared to treatment with non-surgical care alone. Level of evidence I.

scholarly journals Arthroscopic partial meniscectomy versus placebo surgery for a degenerative meniscus tear: a 2-year follow-up of the randomised controlled trial

2017 ◽  
Vol 77 (2) ◽  
pp. 188-195 ◽  
Author(s):  
Raine Sihvonen ◽  
Mika Paavola ◽  
Antti Malmivaara ◽  
Ari Itälä ◽  
Antti Joukainen ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Knee Pain ◽  
Medial Meniscus ◽  
Controlled Trial ◽  
Partial Meniscectomy ◽  
Meniscus Tear ◽  
Arthroscopic Partial Meniscectomy ◽  
Serious Adverse Events ◽  
Secondary Outcomes

ObjectiveTo assess if arthroscopic partial meniscectomy (APM) is superior to placebo surgery in the treatment of patients with degenerative tear of the medial meniscus.MethodsIn this multicentre, randomised, participant-blinded and outcome assessor-blinded, placebo-surgery controlled trial, 146 adults, aged 35–65 years, with knee symptoms consistent with degenerative medial meniscus tear and no knee osteoarthritis were randomised to APM or placebo surgery. The primary outcome was the between-group difference in the change from baseline in the Western Ontario Meniscal Evaluation Tool (WOMET) and Lysholm knee scores and knee pain after exercise at 24 months after surgery. Secondary outcomes included the frequency of unblinding of the treatment-group allocation, participants' satisfaction, impression of change, return to normal activities, the incidence of serious adverse events and the presence of meniscal symptoms in clinical examination. Two subgroup analyses, assessing the outcome on those with mechanical symptoms and those with unstable meniscus tears, were also carried out.ResultsIn the intention-to-treat analysis, there were no significant between-group differences in the mean changes from baseline to 24 months in WOMET score: 27.3 in the APM group as compared with 31.6 in the placebo-surgery group (between-group difference, −4.3; 95% CI, −11.3 to 2.6); Lysholm knee score: 23.1 and 26.3, respectively (−3.2; −8.9 to 2.4) or knee pain after exercise, 3.5 and 3.9, respectively (−0.4; −1.3 to 0.5). There were no statistically significant differences between the two groups in any of the secondary outcomes or within the analysed subgroups.ConclusionsIn this 2-year follow-up of patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after APM were no better than those after placebo surgery. No evidence could be found to support the prevailing ideas that patients with presence of mechanical symptoms or certain meniscus tear characteristics or those who have failed initial conservative treatment are more likely to benefit from APM.

scholarly journals Difference in patient-reported outcomes of various patellar component designs in total knee arthroplasty: A randomized clinical study

2021 ◽  
Vol 29 (1) ◽  
pp. 230949902199606
Author(s):  
Takeshi Mochizuki ◽  
Koichiro Yano ◽  
Katsunori Ikari ◽  
Ken Okazaki
Keyword(s):  
Knee Osteoarthritis ◽  
Clinical Effects ◽  
Patellar Component ◽  
American College Of Rheumatology ◽  
Randomized Clinical Study ◽  
Component Design ◽  
Patient Reported ◽  
Total Knee ◽  
The Difference ◽  
And Function

Purpose: This study investigated the clinical effects of different patellar components without being affected by the femoral component design in total knee arthritis (TKA) for patients with knee osteoarthritis (OA). Methods: In total, 48 patients with OA who met the criteria of the American College of Rheumatology for OA were enrolled and randomly assigned in a 1:1 ratio to two groups according to the usage of patellar component design for TKA (medialized dome type [dome group] or medialized anatomic type [anatomic group]). To evaluate the clinical outcomes for TKA, knee range of motion (ROM), pain intensity of 0–100 mm visual analog scale (pain VAS), and the Japanese Knee Osteoarthritis Measure (JKOM) score were obtained at baseline and year 1. Results: The difference in knee ROM, pain VAS, or total JKOM score at year 1 was not significant between the dome and anatomic groups ( p = 0.398, 0.733 and 0.536, respectively). Moreover, similar results were obtained for changes in knee ROM, pain VAS, or total JKOM scores from baseline. In both groups, the pain VAS and total JKOM scores were significantly improved at year 1. Conclusion: Both dome and anatomic groups in TKA are significantly effective for pain and function using the JKOM score. However, their efficacy did not differ, according to the JKOM score. Results of this study are rare information focusing on the patellar component design and provide one of the insights into the TKA clinical management.

scholarly journals 83 A Medication Self-Management Intervention to Improve Medication Adherence For Older People with Multimorbidity: A Pilot Study

2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i12-i42
Author(s):  
C Yang ◽  
Z Hui ◽  
S Zhu ◽  
X Wang ◽  
G Tang ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Pilot Study ◽  
Older People ◽  
Intervention Group ◽  
Self Management ◽  
Control Group ◽  
Medication Knowledge ◽  
Management Intervention ◽  
Patient Reported

Abstract Introduction Medication self-management support has been recognised as an essential element in primary health care to promote medication adherence and health outcomes for older people with chronic conditions. A patient-centred intervention empowering patients and supporting medication self-management activities could benefit older people. This pilot study tested a newly developed medication self-management intervention for improving medication adherence among older people with multimorbidity. Method This was a two-arm randomised controlled trial. Older people with multimorbidity were recruited from a community healthcare centre in Changsha, China. Participants were randomly allocated to either a control group receiving usual care (n = 14), or to an intervention group receiving three face-to-face medication self-management sessions and two follow-up phone calls over six weeks, targeting behavioural determinants of adherence from the Information-Motivation-Behavioural skills model (n = 14). Feasibility was assessed through recruitment and retention rates, outcome measures collection, and intervention implementation. Follow-up data were measured at six weeks after baseline using patient-reported outcomes including medication adherence, medication self-management capabilities, treatment experiences, and quality of life. Preliminary effectiveness of the intervention was explored using generalised estimating equations. Results Of the 72 approached participants, 28 (38.89%) were eligible for study participation. In the intervention group, 13 participants (92.86%) completed follow-up and 10 (71.42%) completed all intervention sessions. Ten participants (71.42%) in the control group completed follow-up. The intervention was found to be acceptable by participants and the intervention nurse. Comparing with the control group, participants in the intervention group showed significant improvements in medication adherence (β = 0.26, 95%CI 0.12, 0.40, P &lt; 0.001), medication knowledge (β = 4.43, 95%CI 1.11, 7.75, P = 0.009), and perceived necessity of medications (β = −2.84, 95%CI -5.67, −0.01, P = 0.049) at follow-up. Conclusions The nurse-led medication self-management intervention is feasible and acceptable among older people with multimorbidity. Preliminary results showed that the intervention may improve patients’ medication knowledge and beliefs and thus lead to improved adherence.

Comparing Midterm Outcomes of High-Level Athletes Versus Nonathletes Undergoing Primary Hip Arthroscopy: A Propensity-Matched Comparison With Minimum 5-Year Follow-up

2021 ◽  
pp. 036354652110417
Author(s):  
Andrew E. Jimenez ◽  
Peter F. Monahan ◽  
David R. Maldonado ◽  
Benjamin R. Saks ◽  
Hari K. Ankem ◽  
...  
Keyword(s):  
Hip Arthroscopy ◽  
Statistical Significance ◽  
Arthroscopic Surgery ◽  
Harris Hip Score ◽  
Control Group ◽  
Level Of Evidence ◽  
Femoroacetabular Impingement Syndrome ◽  
Patient Reported ◽  
High Level

Background: High-level athletes (HLAs) have been shown to have better short-term outcomes than nonathletes (NAs) after hip arthroscopy. Purpose: (1) To report midterm outcomes of HLAs after primary hip arthroscopy and (2) to compare their results with a propensity-matched cohort of NA patients. Study Design: Cohort study; Level of evidence, 3. Methods: Data were prospectively collected and retrospectively reviewed between February 2008 and November 2015 for HLAs (professional, college, or high school) who underwent primary hip arthroscopy in the setting of femoroacetabular impingement syndrome (FAIS). HLAs were included if they had preoperative, minimum 2-year, and minimum 5-year follow-up data for the modified Harris Hip Score (mHHS), Non-Arthritic Hip Score (NAHS), and Hip Outcome Score Sports-Specific Subscale (HOS-SSS). Radiographic and intraoperative findings, surgical procedures, patient-reported outcomes (PROs), patient acceptable symptomatic state (PASS), minimal clinically important difference (MCID), and return to sport were reported. The HLA study group was propensity-matched to a control group of NA patients for comparison. Results: A total 65 HLA patients (67 hips) were included in the final analysis with mean follow-up time of 74.6 ± 16.7 months. HLAs showed significant improvement in all PROs recorded, achieved high rates of MCID and PASS for mHHS (74.6% and 79.4%, respectively) and HOS-SSS (67.7% and 66.1%, respectively), and returned to sport at high rates (80.4%). When compared with the propensity-matched NA control group, HLAs reported higher baseline but comparable postoperative scores for the mHHS and NAHS. HLA patients achieved MCID and PASS for mHHS at similar rates as NA patients, but the HLA patients achieved PASS for HOS-SSS at higher rates that trended toward statistical significance (66.1% vs 48.4%; P = .07). NA patients underwent revision arthroscopic surgery at similar rates as HLA patients (14.9% vs 9.0%, respectively; P = .424). Conclusion: Primary hip arthroscopy results in favorable midterm outcomes in HLAs. When compared with a propensity-matched NA control group, HLAs demonstrated a tendency toward higher rates of achieving PASS for HOS-SSS but similar arthroscopic revision rates at minimum 5-year follow-up.

Exercise and Osteoarthritis: Are We Stopping Too Early? Findings from the Clearwater Exercise Study

2006 ◽  
Vol 14 (2) ◽  
pp. 169-180 ◽  
Author(s):  
Frances V. Wilder ◽  
John P. Barrett ◽  
Edward J. Farina
Keyword(s):  
Clinical Trials ◽  
Knee Pain ◽  
Exercise Intervention ◽  
Pain Reduction ◽  
Optimal Length ◽  
Knee Oa ◽  
Pain Scores ◽  
Time Periods

The value of exercise for people with knee osteoarthritis (OA) receives continuing consideration. The optimal length of study follow-up time remains unclear. A group of individuals with knee OA participating in an exercise intervention was followed for 2 years. The authors quantified the change in knee-pain scores during Months 1–12 and during Months 13–24. Eleven individuals with radiographic knee OA and knee-pain scores of 2+ were evaluated. Pain scores were collected weekly from participants who exercised three times a week. Participants demonstrated pain reduction during both time periods. Pain reduction during Months 13–24, –10.7%, was slightly higher than pain reduction during Months 1–12, –7.8%. Among people with knee OA who exercise, these findings suggest that knee-pain amelioration continues beyond 12 months. Clinicians should consider encouraging long-term exercise programs for knee-OA patients. To best characterize the effect of exercise on knee pain, researchers designing clinical trials might want to lengthen the studies’ duration.

scholarly journals A case report: Type II Abernethy malformation complicated with congenital polydactyly and enlargement of all cardiac chambers.

2019 ◽  
Author(s):  
Cheng Zhu ◽  
Min Wang ◽  
Qian Hao
Keyword(s):  
Congenital Malformations ◽  
Portacaval Anastomosis ◽  
Test Results ◽  
Abernethy Malformation ◽  
Form And Function ◽  
Laboratory Test Results ◽  
Number Of Patients ◽  
Patient Reported ◽  
And Function

Abstract Background: Abernethy malformation is a kind of congenital malformation of portal vein system caused by abnormal portacaval anastomosis. It can be in combination with other congenital malformations. The major therapy of Abernethy malformation is surgery. There has been a limited number of patients since the first patient reported, leading to a limited view towards this kind of disease until now.Results: In August 2018 we treated a patient diagnosed with typeII Abernethy malformation complicated with both congenital polydactyly and enlargement of all cardiac chambers, which is extremely rare and can be a supplementary to the existing cases. Besides, the low white blood cell and platelet, the arrested megakaryocytic maturation and the positive platelet autoantibody in serum may result in misdiagnosis as immune thrombocytopenia, so we analyze the differential points between these two diseases. We treated this patient with silybin orally and advised him to make follow-up visits because of his mild liver function disorder, normal cardiac function and no other malformations or complications complicated. At the latest follow-up, we knew the condition of the patient was generally satisfactory, whether in terms of laboratory test results or his daily life experience.Conclusions: Because of some changes of spleen in form and function secondary to Abernethy malformation, in some cases, this disease has similarities with a part of blood diseases, which we should take into consideration for differential diagnosis, especially when other congenital malformations are found in combination at the same time. This case also suggests that simply conservative treatment with regular follow-up visits can be suitable for certain patients.

scholarly journals Three-month and six-month outcomes of patients with COVID-19 associated hyperinflammation treated with short-term immunosuppressive therapy: follow-up of the CHIC study

RMD Open ◽  
2021 ◽  
Vol 7 (3) ◽  
pp. e001906
Author(s):  
Marlou THF Janssen ◽  
Sofia Ramiro ◽  
Rémy LM Mostard ◽  
Cesar Magro-Checa ◽  
Robert BM Landewé
Keyword(s):  
Immunosuppressive Therapy ◽  
Outcome Measures ◽  
Normal Population ◽  
Immunosuppressive Treatment ◽  
Control Group ◽  
Medium Term ◽  
Short Term ◽  
Function Tests ◽  
Patient Reported

ObjectivesTo prospectively investigate differences in medium-term patient-reported outcome measures and objective functional outcome measures, between patients receiving and those not receiving intensive short-term immunosuppressive therapy for coronavirus disease 19 (COVID-19)-associated hyperinflammation.MethodsPatients previously included in the COVID-19 High-intensity Immunosuppression in Cytokine storm syndrome (CHIC) study who received immunosuppressive treatment versus standard of care for COVID-19-associated hyperinflammation were invited for follow-up at 3 and 6 months after hospitalisation. At both visits, patients were assessed by a pulmonologist, completed quality of life (QoL) questionnaires and performed pulmonary and exercise function tests. At 3 months, patients additionally completed questionnaires on dyspnoea, anxiety, depression and trauma. Outcomes were compared between patients receiving and those not receiving intensive short-term immunosuppressive therapy for COVID-19-associated hyperinflammation.Results131 (66.5%) patients survived hospitalisation due to COVID-19-associated hyperinflammation and 118 (90.1%) were included. QoL questionnaires, pulmonary- and exercise function tests showed improvement between 3 and 6 months after discharge, which was similar in both groups. Assessed patients reached levels that were close to levels predicted from the normal population. In contrast, diffusing capacity of the lung for carbon monoxide was disturbed in both groups: 69.6% predicted (SD 16.2) and 73.5% predicted (SD 16.5) in control group and treated group, respectively.ConclusionsNo differences in medium-term outcomes are demonstrated in survivors of COVID-19-associated hyperinflammation treated or not treated with methylprednisolone with or without tocilizumab during the acute phase. Short-term benefits of this therapy, as showed in the baseline CHIC study analysis, are thus not hampered by medium-term adverse events.

scholarly journals The Effect of a Lower Body Positive Pressure Supported Treadmill Exercise Regime on Systemic Biomarkers of Inflammation and Cartilage Degradation in Individuals with Knee Osteoarthritis: A Pilot Study

2021 ◽  
Vol 9 (3) ◽  
pp. 18
Author(s):  
Stephen Cornish ◽  
Jason Peeler
Keyword(s):  
Articular Cartilage ◽  
Knee Pain ◽  
Weight Bearing ◽  
Cartilage Degradation ◽  
Treadmill Walking ◽  
Positive Pressure ◽  
Control Group ◽  
Knee Oa ◽  
And Cartilage

Background: Knee osteoarthritis (OA) has been linked to a chronic low-grade inflammatory response and altered metabolic activity of articular cartilage. Objective: The purpose of this investigation was to evaluate the effectiveness of a 12-week (3 times/week) lower body positive pressure (LBPP) treadmill walking regime on knee pain and systemic biomarkers of inflammation and cartilage degradation. Methods: Sixteen overweight (BMI > 25 kg/m2) knee OA patients were randomized to a LBPP treadmill walking exercise group (N = 7) or non-exercise control group (N = 9). Baseline and 12-week follow-up assessments evaluated the following dependent variables: acute knee pain during full weight bearing treadmill walking; inflammatory biomarkers (C-reactive protein, interleukin-1β, interleukin-6, s100A8/A9, and tumor necrosis factor-α), and catabolic metabolism of articular cartilage (sCOMP). Results: Knee pain at baseline and follow-up remained unchanged for the non-exercise control group (P > 0.05). However, knee pain for the LBPP exercise group was significantly decreased at follow-up (P ≤ 0.05). No differences in the biomarkers of inflammation and cartilage degradation were observed for between and within group comparisons (all P > 0.05). Conclusions: Data suggested that the LBPP supported walking regime could be effectively used to promote regular weight bearing exercise without exacerbation of knee joint pain and did not increase levels of systemic inflammation or catabolic activity of articular cartilage in overweight knee OA patients. This pilot investigation offers important insight regarding the potential role that the LBPP technology could play in facilitating investigations examining the disease modifying effect of exercise on knee OA pathogenesis.

scholarly journals Left Atrial Shape and Function after Endovascular Device and Surgical Closure of ASDs in Children

2021 ◽  
Author(s):  
Alexander Sokolov ◽  
Viktor Varvarenko ◽  
Evgeny Krivoshchekov ◽  
Andrey Smorgon
Keyword(s):  
Left Atrium ◽  
Left Atrial ◽  
Surgical Correction ◽  
Control Group ◽  
Surgical Closure ◽  
Younger Age ◽  
Asd Closure ◽  
And Function ◽  
Endovascular Device

Retrospective analysis of echocardiograms was performed in 756 children who received endovascular device or surgical ASD closure from 2006 to 2016 in the Cardiac Center in Tomsk Russia. 564 patients had an endovascular closure and 192 had surgical correction. Follow-up duration was from 1 day to 10 years, mean 3.6 yrs for the device group and 4.2 yrs for the surgery group. The control group consisted of 3393 age-matched healthy patients. In patients with endovascular closure of an ASD, 35% had a change in the shape of the left atrium in early follow-up. Changes in the shape of the left atrium at early follow-up were more often observed in the device group and in children of a younger age. The left atrial changes were a decrease in sphericity and an increase in ellipsoidy. Changes in the shape of the left atrium persisted in 22% after transcatheter correction in the long-term. The change in shape of the left atrium after the placement of ASD devices was accompanied by activation of the mechanical function of the atrium and an increase in the filling pressure of the left ventricle. These changes were not accompanied by any disturbance in the contractility and volume of the heart chambers. In the group with surgical correction of ASD, the contractility and volume of the heart chambers did not significantly differ from those in the device closure group

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