Rationale, design and methodology of APPROACH-IS II: International study of patient-reported outcomes and frailty phenotyping in adults with congenital heart disease.

BACKGROUND: In recent years, patient-reported outcomes (PROs) have received increasing prominence in cardiovascular research and clinical care. An understanding of the variability and global experience of PROs in adults with congenital heart disease (CHD), however, is still lacking. Moreover, information on epidemiological characteristics and the frailty phenotype of older adults with CHD is minimal. The APPROACH-IS II study was established to address these knowledge gaps. This paper presents the design and methodology of APPROACH-IS II. METHODS/DESIGN: APPROACH-IS II is a cross-sectional global multicentric study that includes Part 1 (assessing PROs) and Part 2 (investigating the frailty phenotype of older adults). With 53 participating centers, located in 32 countries across six continents, the aim is to enroll 8000 patients with CHD. In Part 1, self-report surveys are used to collect data on PROs (e.g., quality of life, perceived health, depressive symptoms, autonomy support), and explanatory variables (e.g., social support, stigma, illness identity, empowerment). In Part 2, the cognitive functioning and frailty phenotype of older adults are measured using validated assessments. DISCUSSION: APPROACH-IS II will generate a rich dataset representing the international experience of individuals in adult CHD care. The results of this project will provide a global view of PROs and the frailty phenotype of adults with CHD and will thereby address important knowledge gaps. Undoubtedly, the project will contribute to the overarching aim of improving optimal living and care provision for adults with CHD.

Education as important predictor for successful employment in adults with congenital heart disease worldwide.

BACKGROUND: Conflicting results have been reported regarding employment status and work ability in adults with congenital heart disease (CHD). Since this is an important determinant for quality of life, we assessed this in a large international adult CHD cohort. METHODS: Data from 4028 adults with CHD (53% women) from 15 different countries were collected by a uniform survey in the cross-sectional APPROACH International Study. Predictors for employment and work limitations were studied using general linear mixed models. RESULTS: Median age was 32 years (IQR 25-42) and 94% of patients had at least a high school degree. Overall employment rate was 69%, but varied substantially among countries. Higher education (OR 1.99-3.69) and having a partner (OR 1.72) were associated with more employment; female sex (OR 0.66, worse NYHA functional class (OR 0.67-0.13), and a history of congestive heart failure (OR 0.74) were associated with less employment. Limitations at work were reported in 34% and were associated with female sex (OR 1.36), increasing age (OR 1.03 per year), more severe CHD (OR 1.31-2.10), and a history of congestive heart failure (OR 1.57) or mental disorders (OR 2.26). Only a university degree was associated with fewer limitations at work (OR 0.62). CONCLUSIONS: There are genuine differences in the impact of CHD on employment status in different countries. Although the majority of adult CHD patients are employed, limitations at work are common. Education appears to be the main predictor for successful employment and should therefore be encouraged in patients with CHD.

Comparison of participants and non-participants in patient-reported outcome surveys: the case of Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study.

BACKGROUND: The last decade has seen a vast increase in the use of patient-reported outcomes. As patient-reported outcomes are used in order to capture patients' perspectives of their health and illness, it is a prerequisite for accurate patient-reported outcome evaluations to use representative samples. In order to evaluate representativeness, the present study focussed on the comparison between participants and non-participants in the Swedish branch of the international study APPROACH-IS (Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study), regarding demographic, clinical, and health status characteristics. METHODS: Eligible patients for APPROACH-IS were identified and selected from SWEDCON, the Swedish registry for congenital heart disease (CHD). Overall, 912 eligible patients were identified, of whom 471 participated, 398 did not participate, and 43 were either unreachable or declined to participate in APPROACH-IS. The participants and non-participants were compared in terms of statistical significance and effect sizes. RESULTS: Significant differences were observed between participants and non-participants for sex, age, primary diagnosis, number of cardiac operations, and fatigue; however, the effect sizes were in general small, except for the difference in primary diagnosis. No differences between the two groups were found in number of catheterisations, implanted device, the distribution of NYHA functional class, or health status and symptoms. CONCLUSIONS: This study shows that participants and non-participants are relatively comparable groups, which confirms the representativeness of the participants. The Swedish data from APPROACH-IS can therefore be reliably generalised to the population of adults with CHD in Sweden.

Quality of Life of Adults With Congenital Heart Disease in 15 Countries: Evaluating Country-Specific Characteristics.

BACKGROUND: Measuring quality of life (QOL) is fundamental to understanding the impact of disease and treatment on patients' lives. OBJECTIVES: This study aimed to explore QOL in an international sample of adults with congenital heart disease (CHD), the association between patient characteristics and QOL, and international variation in QOL and its relationship to country-specific characteristics. METHODS: We enrolled 4,028 adults with CHD from 15 countries. QOL was assessed using a linear analog scale (LAS) (0 to 100) and the Satisfaction with Life Scale (SWLS) (5 to 35). Patient characteristics included sex, age, marital status, educational level, employment status, CHD complexity, and patient-reported New York Heart Association (NYHA) functional class. Country-specific characteristics included general happiness and 6 cultural dimensions. Linear mixed models were applied. RESULTS: Median QOL was 80 on the LAS and 27 on the SWLS. Older age, lack of employment, no marriage history, and worse NYHA functional class were associated with lower QOL (p < 0.001). Patients from Australia had the highest QOL (LAS: 82) and patients from Japan the lowest (LAS: 72). Happiness scores and cultural dimensions were not associated with variation in QOL after adjustment for patient characteristics and explained only an additional 0.1% of the variance above and beyond patient characteristics (p = 0.56). CONCLUSIONS: This large-scale, international study found that overall QOL in adults with CHD was generally good. Variation in QOL was related to patient characteristics but not country-specific characteristics. Hence, patients at risk for poorer QOL can be identified using uniform criteria. General principles for designing interventions to improve QOL can be developed.

Catheter closure of atrial septal defect in the elderly (≥65years). A worthwhile procedure.

BACKGROUND: Secundum atrial septal defect (ASD2) is one of the most common cardiac malformations diagnosed in adult life. Catheter closure has made treatment possible even in patients of high age. However, published outcome data for elderly patients is limited. The aim of this study was to report, on a national basis, the long-term outcome of ASD2 catheter closure in the elderly. MATERIAL AND RESULTS: We report the clinical and echocardiographic outcome of catheter closure of ASD2 in 148 patients aged 65-87years. Data was obtained from a national registry, medical records and a questionnaire. The proportion of patients in NYHA I increased from 34% to 61% (p<0.001) one year after closure and remained stable at the latest follow-up 4,4 (SD 2,6) years post-closure. The proportion of patients with moderate/severe enlargement of the right ventricle and atrium fell from 77% and 76% to 25% and 40%, respectively, (p<0.001) and right ventricular systolic pressure dropped significantly. Improvement of NYHA class was associated with reduced right ventricular systolic pressure but not with remodelling of the right heart. NYHA deteriorated in 9 patients, despite reduced right ventricular size. Overall, the prevalence of atrial fibrillation was unchanged after closure. Major complication rate was 2% and there was no procedure- or device-related mortality. CONCLUSION: Catheter closure of ASD2 in the elderly is a worthwhile procedure since it improves symptoms and has a low complication rate. However, a subset of patients do not improve, in which we suggest that concealed left ventricular dysfunction may play a causative role.

Long-Term Outcome of Mustard/Senning Correction for Transposition of the Great Arteries in Sweden and Denmark.

BACKGROUND: The atrial switch operation, the Mustard or Senning operation, for the transposition of the great arteries (TGA) was introduced in the late 1950s and was the preferred surgery for TGA until the early 1990s. The Mustard and Senning operation involves extensive surgery in the atria and leaves the right ventricle as the systemic ventricle. The Mustard and Senning cohort is now well into adulthood and we begin to see the long-term outcome. METHODS AND RESULTS: All the 6 surgical centers that performed Mustard and Senning operations in Sweden and Denmark identified all operated TGA patients. Information about death was obtained in late 2007 and early 2008 from the Danish and Swedish Centralised Civil Register by using the patients' unique national Civil Registration Numbers. Four hundred sixty-eight patients undergoing the atrial switch operation were identified. Perioperative 30-day mortality was 20%, and 60% were alive after 30 years of follow-up. Perioperative mortality was significantly increased by the presence of a ventricular septal defect, left ventricular outflow obstruction, surgery early in the Mustard and Senning era. However, only pacemaker implantation is predictive of long-term outcome (hazard ratio, 1.90; 95% confidence interval, 1.05-3.46, P=0.04), once the TGA patient has survived the perioperative period. The risk of reoperation was correlated to the presence of associated defects and where the first Mustard/Senning operation was performed. CONCLUSIONS: The long-term survival of patients with Mustard and Senning correction for TGA appears to be primarily determined by factors in the right ventricle and tricuspid valve and not the timing of or the type of surgery in childhood. Cardiac function necessitating the implantation of a pacemaker is associated with an increase in mortality.

Strategies and outcomes of periprocedural bridging therapy with low-molecular-weight heparin in patients with mechanical heart valves.

Patients with mechanical heart valves (MHV) undergoing invasive procedures often receive periprocedural bridging with low-molecular-weight heparin (LMWH). The bridging strategies used in real-life and the predictors for bleeding and thrombosis are not well studied. We retrospectively assessed patients with MHV that underwent invasive procedures requiring vitamin K antagonist interruption and LMWH bridging. Thromboembolic and bleeding events occurring up to 30 days after the procedures were recorded. Predictors of major bleeding events (MBEs) were analyzed with logistic regression. We evaluated 547 patients with MHV who underwent 275 procedures during a 6.5-year period. Bridging with LMWH was used in 185 procedures in a total of 117 patients. Combined pre- and post-operative bridging was the most frequently employed (63 %). Doses of LMWH were prophylactic in 96 (52 %) of the procedures and therapeutic in 89 (48 %). The procedure-related bleeding risk was evaluated as high in 70 (38 %) and low in 115 (62 %) of the procedures. There was a trend to more frequent use of prophylactic doses (61 %) in high-risk surgery, and more therapeutic doses (53 %) in low-risk ones. There were 36 bleeding episodes, 21 (11 % of procedures) of which were classified as MBEs, but there were no thromboembolic events. Most MBEs (n = 14; 67 %) occurred in surgeries with high bleeding risk. In the multivariate analysis, the bleeding risk of the surgery itself was the only independent predictor for MBEs. For patients with MHV receiving perioperative bridging with LMWH, the major predictor for MBE is the bleeding risk of the surgery.

Functioning and quality of life in adults with mild-to-moderate osteogenesis imperfecta.

PURPOSE: The aim of this study was to describe physical activity, quality of and satisfaction with life, pain, joint mobility and muscle function in adults with mild-to-moderate osteogenesis imperfecta (OI) to form the basis of improved clinical care and physical therapy treatment. METHOD: A total of 40 men and women aged between 21 and 71 years were identified and a prospective, cross-sectional study was performed on 29 (18 women) included participants. The participants had to be able to walk and to have a diagnosis of mild-to-moderate OI. Self-administered questionnaires and clinical examinations were used. RESULTS: Difficulties were found in all domains of the International Classification of Functioning, Activity and Health. Pain was reported in 25 of 29 participants and scoliosis was found in 23 participants. Difficulty to run was estimated in 18 participants. A total of 19 of 27 participants reported reaching the recommendations of 30 min of moderate-intensity activity preferably every day. Life satisfaction was high even though health-related quality of life, assessed with the Short Form 36, was significantly lower than the Swedish norm. CONCLUSION: Impairments and activity limitations involved pain, scoliosis, contractures as well as trouble with running, heavy lifting, heavy work and sports. This study show that individuals with mild-to-moderate OI perceive themselves as having decreased health-related quality of life and this seems to depend on decreased physical functioning. Despite that, as a group, they estimated high life satisfaction and 19 participants reported adhering to the general recommendation of 30 min of moderate-intensity activity preferably every day.

Clinical implications of azole resistance in Aspergillus fumigatus, The Netherlands, 2007-2009.

The prevalence and spread of azole resistance in clinical Aspergillus fumigatus isolates in the Netherlands are currently unknown. Therefore, we performed a prospective nationwide multicenter surveillance study to determine the effects of resistance on patient management strategies and public health. From June 2007 through January 2009, all clinical Aspergillus spp. isolates were screened for itraconazole resistance. In total, 2,062 isolates from 1,385 patients were screened; the prevalence of itraconazole resistance in A. fumigatus in our patient cohort was 5.3% (range 0.8%-9.5%). Patients with a hematologic or oncologic disease were more likely to harbor an azole-resistant isolate than were other patient groups (p<0.05). Most patients (64.0%) from whom a resistant isolate was identified were azole naive, and the case-fatality rate of patients with azole-resistant invasive aspergillosis was 88.0%. Our study found that multiazole resistance in A. fumigatus is widespread in the Netherlands and is associated with a high death rate for patients with invasive aspergillosis.

Left ventricular hypertrophy in incident dialysis patients randomized to treatment with hemofiltration or hemodialysis: results from the ProFil study.

INTRODUCTION: Left ventricular hypertrophy (LVH) is present in a majority of hemodialysis (HD) patients and is among the strongest risk factors for cardiovascular events and mortality. Hemofiltration (HF), a purely convective dialysis treatment, has been associated with enhanced hemodynamic stability compared with HD, possibly as a result of a more physiologic removal of fluid and solutes. METHODS: In a randomized controlled study conducted at ten dialysis centers in Sweden and Denmark, incident patients (HD <3 months) without clinical signs or history of cardiovascular disease were randomized to treatment with either online, predilution HF or low-flux HD. The primary endpoint was change in left ventricular mass index (LVMI), as measured by two-dimensional M-mode and Doppler echocardiography. RESULTS: The analyses included 34 patients (18 HF, 16 HD) followed for up to 2 years. At baseline, 65% of the patients had LVH, but LVMI did not differ between the study groups. In the HF group, LVMI decreased by 22 ± 48 g/m(2) during a mean treatment time of 19 ± 7 months, while in the HD group the decrease was 15 ± 57 g/m(2) during 16 ± 7 months. As analyzed by MANOVA (mixed model), the difference in LVMI over the whole period was statistically significant (p = 0.03) with a more favorable outcome in HF. Blood pressure and other study variables did not differ between the groups, but at baseline and throughout the study, HF patients required heavier antihypertensive treatment. CONCLUSIONS: In incident dialysis patients, long-term predilution HF, a purely convective dialysis treatment, is associated with a significantly more favorable development of LVMI compared with regular low-flux HD. Considering the predictive strength of LVMI as a risk factor, the quantitative difference between the treatments is of clinical importance.

Adolescents' perceptions of obesity treatment--an interview study.

PURPOSE: To describe adolescents' perceptions of obesity treatment in order to provide valuable information for design and development of treatment. METHOD: A nominated sample of 18 obese adolescents (12 girls, 14-16 years, body mass index (BMI) 25-47.4 kg·m(-2)), recruited from a paediatric obesity clinic, participated in semi-structured interviews. These were analysed using a phenomenographic research approach. Purposeful sampling reflected variations in age, gender, degree of obesity, weight loss achievement, ethnicity, time of registration and socioeconomic status. RESULTS: The adolescents expressed numerous physical, psychological and social disabilities as a consequence of their obesity. Qualitatively different ways of perceiving and responding to obesity treatment were identified and could be described in six categories of descriptions and a two-dimensional construct for interpreting these categories; (a) personal empowerment, (b) despair and disappointment, (c) safety and relief, (d) ambivalence and uncertainty, (e) acceptance and realisation and (f) shame and guilt. The distinguishing structures to be found between the categories were as follows: focus on the individual and focus on body weight. CONCLUSIONS: Treatment strategies must consider the large impact obesity has on adolescents' lives. It is necessary to engage the obese adolescent personally in the treatment process and to focus on the adolescents' personal needs, goals and motive for weight reduction.

Glossopharyngeal pistoning for lung insufflation in children with spinal muscular atrophy type II.

AIM: To evaluate whether children with spinal muscular atrophy (SMA) type II were able to learn glossopharyngeal pistoning for lung insufflation (GI), and to evaluate the effects of GI on pulmonary function and chest expansion. METHODS: Eleven children with SMA type II were recruited. They performed 10 cycles of GI, four times per week, for 8 weeks. Lung function and chest expansion were measured before and after the 8-week period. RESULTS: Five of the 11 children learned the technique. The median GI volume was 0.28 (range 0.15-0.98) L. Four of the children who completed the study showed a mean increase in inspiratory vital capacity (IVC) of 0.13 L (95% confidence interval (CI) 0.03-0.23) and peak expiratory flow (PEF) of 116 L/min (95% CI 60-173). They also had an increased chest expansion with GI at the level of the xiphoid process of 1.50 cm (95% CI 0.16-2.84) and at the level of the fourth costa of 1.79 cm (95% CI 0.85-2.73). The children reported temporary symptoms of dizziness and tension in the chest. CONCLUSION: Five of the 11 children were able to learn the technique of GI and for the four who fulfilled the training, it had positive effects on IVC, PEF and chest expansion. GI did not cause major discomfort.

Fear-avoidance beliefs and pain as predictors for low physical activity in patients with leg ulcer.

BACKGROUND AND PURPOSE: Previous studies have shown that patients with chronic venous insufficiency are deconditioned and physically inactive. The present study aimed to examine the occurrence of fear-avoidance beliefs in patients with chronic venous insufficiency, and to investigate the role of fear-avoidance beliefs and pain severity in predicting the low level of physical activity in these patients. METHOD: Data were collected by a postal questionnaire sent to 146 patients with chronic venous insufficiency and current or previous venous leg ulcer. Complete data were collected from 98 patients aged 60-85 years - 63% women - giving a response rate of 67%. Fear-avoidance beliefs were assessed by the Fear-Avoidance Beliefs Questionnaire, physical activity subscale. Pain and physical activity were assessed by the Six-point Verbal Rating Scale of Pain Assessment and the Physical Activity Questionnaire, respectively. RESULTS: Fear-avoidance beliefs were present in 81 (83%) of the patients with chronic venous insufficiency (range 0-24, median 12). Forty patients (41%) had strong fear-avoidance beliefs. One-third of the patients with healed ulcers had strong fear-avoidance beliefs. Patients with low physical activity had significantly stronger fear-avoidance beliefs and more severe pain than patients with high physical activity. Multiple logistic regression showed that the odds ratio (OR) for low physical activity were about three times higher for patients with strong fear-avoidance beliefs (OR 3.1, 95% confidence interval 1.1-8.3; p = 0.027) than for patients with weak fear-avoidance beliefs. CONCLUSIONS: Fear-avoidance beliefs were present in most patients with chronic venous insufficiency and were associated with low physical activity. Clinical implications ought to include a better recognition of fear-avoidance beliefs, early information about the negative consequences of such beliefs, and the importance of physical activity to counteract poor mobility.

Six-minute walk test in obese children and adolescents: reproducibility and validity.

BACKGROUND AND PURPOSE: The six-minute walk test (6MWT) is increasingly used in clinical practice. The aims of this study were to determine the reproducibility of the 6MWT in obese children and adolescents, to describe walking capacity in this population and compare the results with values from normal-weight children (known group validity), and, finally, to describe the correlation between distance walked and estimated maximum oxygen uptake (VO(2)max). METHODS: Reproducibility was determined by a test-retest design and known group validity by a comparative design. The 6MWT was first test-retested in 49 obese children (30 boys, 19 girls, 8-16 years, body mass index [BMI] 24.9-52.1 kg?m(-2)). Then, for validation, 250 obese children (126 boys, 124 girls, 8-16 years, BMI 23.2-57 kg/m(2)) and 97 normal-weight children (48 boys, 49 girls, 8-16 years, BMI 13.3-23.2 kg.m(-2)) performed the 6MWT. The obese children also performed a sub-maximal bicycle ergometry test. RESULTS: In the test-retest, the obese children walked 571 m the first test and 57 m the second (p = 0.578). The measurement error (S(w)) was 24 m, coefficient of variation (CV): 4.3% and the intraclass correlation (ICC1:1): 0.84. Repeatability was 68 m, and limits of agreement were +71 and -65 m. In comparison mean (standard deviation), six-minute walk distance (6MWD) in the obese children was 571 m (65.5), and in the normal-weight children, 663 m (61.1) (p < 0.001). The correlation between 6MWD and estimated VO(2)max (r = 0.34) was low. CONCLUSIONS: The 6MWT showed good reproducibility and known group validity, and can be recommended for use in clinical practice in the studied population. To evaluate individual outcomes after intervention, the 6MWD needs to change by >68 m to be statistically significant. The 6MWD performed by obese children averaged 86% of the distance normal-weight children walked. In obese children, the correlation between 6MWD and estimated VO(2)max was low, hence the 6MWT cannot substitute a bicycle ergometry test.

Urinary incontinence in very young and mostly nulliparous women with a history of regular organised high-impact trampoline training: occurrence and risk factors.

The aim of this study was to examine the occurrence of urinary incontinence (UI) in mostly nulliparous women with a history of regular organised trampoline training as adolescents and to identify possible predictors. Female trampolinists in Sweden with licence for trampolining between 1995--1999 (n = 305), with a median age of 21 (range 18-44) years answered retrospectively a validated questionnaire. Competition with double somersaults had been performed by 85 women, the "competition group" (CG), while 220 women comprised the "recreational group" (RG). Of the trampolinists with UI during trampolining, 76% continued to leak. In CG, 57% and, in RG, 48% reported current UI. Strong predictors for UI were inability to interrupt micturition (p < 0.001) and constipation (p = 0.007). Training factors such as frequency/week x years of trampolining (p < 0.001) and years of trampolining after menarche increased the risk of UI (p < 0.001). The prevalence of current UI was higher in ex-trampolinists than in normals (p < 0.001), and hence the negative effects of trampolining cannot be ruled out.

Urinary incontinence in women with low back pain.

Urinary incontinence (UI) is a common female dysfunction, affecting women in all ages. Experienced physiotherapists and experts on low back pain (LBP) have since long observed and discussed the empirical association between LBP and UI. The aim of this study was to describe the occurrence of UI in women with LBP and to compare this group with a reference group of comparable age, language, culture and parity. The authors of this study had previously collected all original data from the reference group. A validated questionnaire concerning UI was answered by 200 consecutive women with LBP visiting specialised physiotherapy clinics in the area of Stockholm. Inclusion criteria were LBP, female, not pregnant, Swedish speaking, age between 17 and 45 years. Seventy-eight percent of the women with LBP reported UI. In comparison with the reference group, the prevalence of UI and signs of dysfunctional pelvic floor muscles (PFM) were greatly increased (p < 0.001) in the LBP group. Logistic regression analysis showed that the condition LBP and PFM dysfunction i.e. inability to interrupt the urine flow (p < 0.001) were risk factors for UI irrespective of parity. Physiotherapists treating patients with LBP should be aware of possible incontinence problems in this patient group.

Staphylococcal peptidoglycan initiates an inflammatory response and procoagulant activity in human vascular endothelial cells: a comparison with highly purified lipoteichoic acid and TSST-1.

Staphylococcus aureus is one of the most significant pathogens in human sepsis and endocarditis. A hallmark of these endovascular S. aureus infections is that the coagulation system is triggered by a tissue factor (TF)-dependent pathway. This study demonstrates that highly purified S. aureus peptidoglycan, lipoteichoic acid (LTA) and TSST-1 increase TF mRNA and TF surface protein in human umbilical vein endothelial cells (ECs). Concomitantly, peptidoglycan- and LTA-activated ECs express significant TF-dependent procoagulant activity (TF PCA). In addition peptidoglycan, but not LTA or TSST-1, induced surface expression of the EC inflammation markers ICAM-1 and VCAM-1, which supported the adhesion of monocytes to these ECs. During the coculture of peptidoglycan-activated ECs and adherent monocytes, a marked additional increase of TF PCA was observed. Marginal increases in TF PCA were observed in cocultures of monocytes with LTA- or TSST-1-activated ECs. This study defines in particular staphylococcal peptidoglycan, previously known as a potent initiator of TF PCA in monocytes, as also being an activator of a coagulant response in human ECs that is further intensified by the presence of surface-bound monocytes.

Effects of glossopharyngeal pistoning for lung insufflation on vital capacity in healthy women.

OBJECTIVES: To determine whether healthy women could be trained to perform glossopharyngeal pistoning (GP) to insufflate the lungs to volumes exceeding maximum inspiratory capacity (IC), whether such insufflation caused discomfort, and the immediate and long-term effects on vital capacity (VC). DESIGN: A randomized controlled trial. Twenty-six healthy women were randomly assigned to a training group (TG, n = 17) or to a control group (CG, n = 9). The TG performed 15-30 deep inspiratory efforts supplemented by GP to lung volumes exceeding IC, three times per week for 6 wks. Pulmonary function and chest expansion were measured before and after the 6-wk period. The TG was retested again 12 wks after the end of the training period. RESULTS: One of 17 women had difficulty performing GP and was excluded. Temporary symptoms (while performing GP) were reported in 44% of subjects in the TG. After 6 wks of training, subjects in the TG had significantly increased their VC (P < 0.001). VC did not change in the CG. The increase in vital capacity of the TG was still evident after 12 wks without performing GP. Chest expansion increased significantly with GP. CONCLUSION: The women in the TG were able to perform the technique, and it did not cause major discomfort. VC increased significantly in the TG, and the increase was still present after 12 wks without GP.

Edge-to-edge mitral repair without annuloplasty in combination with surgical ventricular restoration.

BACKGROUND: Functional mitral regurgitation is common in ischemic dilated cardiomyopathy. Edge-to-edge repair is an option for correction and can be performed through the ventriculotomy during surgical ventricular restoration (SVR). This report describes the durability of the edge-to-edge repair without annuloplasty in combination with SVR. METHODS: From March 1997 to July 2002, 31 patients with left ventricular aneurysm or ischemic dilated cardiomyopathy and functional ischemic mitral regurgitation grade II (n = 18), III (n = 10), and IV (n = 3) underwent SVR and edge-to-edge repair without annuloplasty with concomitant coronary artery bypass grafting. Long-term valve competence was assessed by echocardiography. Early and late survival and hospital readmission for heart failure were analyzed. RESULTS: Early mortality was 5 (16%) of 31 patients. At 1, 3, and 5 years, actuarial survival was 77%, 55%, and 48%. The cumulative follow-up was 117 patient-years (4.5 years mean follow-up). Late echocardiograms performed at a mean of 3.1 years postoperatively showed patients had mitral regurgitation at grade 0 (n = 4), I (n = 10), II (n = 9), and III (n = 1). Two patients underwent reoperation owing to grade III-IV recurrent mitral regurgitation. Freedom from hospital readmission or cardiac death was 56% at 1 year and 48% at 3 years. CONCLUSIONS: Combined mitral valve repair and SVR carries high operative risk and long-term prognosis is worse than after SVR alone. The edge-to-edge repair without annuloplasty for functional ischemic mitral regurgitation seems to be fairly durable in conjunction with SVR. To improve results a transventricular annuloplasty may be added.