International Journal of Cardiology 168 (2013) 294–299 Contents lists available at ScienceDirect International Journal of Cardiology j ourna l homepage: www.e lsev ie r .com/ locate / i j ca rd Implantation of cardioverter-defibrillator: Effects on shoulder function Igor Diemberger a,⁎, Francesco Pegreffi b, Andrea Mazzotti a, Elia Foschi c, Cristian Martignani a, Guido Belli c, Mauro Biffi a, Matteo Ziacchi a, Angelo Branzi a, Francesco Grigioni a, Pasqualino Maietta Latessa c, Giuseppe Porcellini d, Claudio Tentoni c, Giuseppe Boriani a a Institute of Cardiology, University of Bologna, Azienda Ospedaliera S.Orsola-Malpighi, Bologna, Italy b Institute of Sport Medicine, University of Bologna, Bologna, Italy c Department of Histology, Embryology and Applied Biology, School of Exercise and Sport Sciences, University of Bologna, Bologna, Italy d Unit of Shoulder and Elbow Surgery, “D. Cervesi” Hospital, Cattolica, Italy ⁎ Corresponding author at: Institute of Cardiology, Un S. Orsola-Malpighi, Via Massarenti n. 9, 40138 Bologna fax: +39 051344859. E-mail address:
[email protected] (I. Diem 0167-5273/$ – see front matter © 2012 Elsevier Ireland http://dx.doi.org/10.1016/j.ijcard.2012.09.071 a b s t r a c t a r t i c l e i n f o Article history: Received 28 September 2011 Received in revised form 2 May 2012 Accepted 15 September 2012 Available online 7 October 2012 Keywords: Implantable defibrillator Heart failure Shoulder pain Shoulder impingement Background: Subcutaneous almost substituted subpectoral approach of implantable cardioverter-defibrillator (ICD) implantation as a less invasive surgical technique. However, the impact of this change in placement site on procedure-related shoulder impairment is poorly understood. Methods: Candidates for ICD implantation were prospectively evaluated at baseline, 2-weeks and 3-months after the procedure. Assessment of shoulder function included: Constant Score, Numeric Rating Scale (NRS) for pain and the Disability of the Arm, Shoulder and Hand (DASH) scoring method. The Short Form-36 (SF-36) questionnaire was adopted for quality of life. Results: Fifty consecutive patients were enrolled (21 single-chamber, 5 dual-chamber and 24 biventricular ICD). Significant changes in the short term were observed: physical component summary (regarding SF-36) decreased from 44.5±9.1 to 41.8±11.4 (p=0.016), patients with NRS >1 increased from 14% to 44% (pb0.001), DASH score increased from 1.29 [interquartile range 0.00–10.34] to 30.60 [interquartile range 12.93–46.34] (pb0.001). Notably, only the shoulder ipsilateral to implantation site presented a decrease in Constant Score (76.00 [interquartile range 61.37–86.87] vs. 95.75 [interquartile range 91.37– 98.00]; pb0.001). After three months most of the parameters seemed to have recovered, except for range of motion. Procedure-related increase in pain (i.e. NRS increase ≥1 point) was the most important indepen- dent predictor of shoulder impairment, in terms of Constant Score modification (r=0.570; pb0.001). Conclusions: ICD implantation is frequently associated with ipsilateral shoulder impairment which tends to recover within 3-months. These data positively compare with the subpectoral approach and should be considered for future research regarding impact of ICD implant on physical well-being and quality of life. © 2012 Elsevier Ireland Ltd. All rights reserved. 1. Introduction The increasing knowledge regarding ventricular arrhythmias and risk stratification for sudden cardiac death promotes a widening of the indication for implantation of a implantable cardioverter-defibrillator (ICD) in primary prevention [1]. These data coupled with the awareness that the patients most likely to benefit from ICD therapy are those with lesser physical impairment (i.e. lower New York Heart Association (NYHA) class and fewer comorbidities) are lowering the average age of the ICD implanted population [2]. However, in a group of patients with less general impairment at baseline, adverse events related to ICD implantation, though mild, could significantly affect overall well-being. In particular, a frequent problem like the ipsilateral arm and shoulder iversity of Bologna, Policlinico , Italy. Tel.: +39 051349858; berger). Ltd. All rights reserved. functional disability induced by ICD implantation, which has been documented with subpectoral ICD positioning [3], has never been the subject of study since the general adoption of the subcutaneous ap- proach [4]. The aim of this prospective, single-center study was to eval- uate the impact of routine subcutaneous ICD implantation on the shoulder joint, in particular focusing on shoulder-related pain, motility and disability together with the impact on patient quality of life (QoL). 2. Methods 2.1. Eligibility criteria All patients referred to our institutes for ICD implantation (single chamber, dual chamber or cardiac resynchronization devices) according to current guidelines [5,6] between January and May 2011 were considered for enrollment in this prospective study. This observational study was approved by the local ethics committee and all patients gave informed consent to participate. To better define the real impact of insertion of a subcutaneous ICD on the development of shoulder disability, we decided to exclude all the subjects who, at baseline, presented a significant limitation due to known shoulder diseases, fractures or surgery or who were affected by a known http://dx.doi.org/10.1016/j.ijcard.2012.09.071 mailto:
[email protected] http://dx.doi.org/10.1016/j.ijcard.2012.09.071 http://www.sciencedirect.com/science/journal/01675273 295I. Diemberger et al. / International Journal of Cardiology 168 (2013) 294–299 neuromuscular disease. Patients with a history of milder shoulder disability without significant impairment at the assessment performed before ICD implantation were not excluded but this information was recorded. This decision was made by the study team composed of one cardiologist, one orthopedic surgeon and a kinesiology specialist. 2.2. Clinical and instrumental evaluation All patients underwent a standard baseline evaluation according to our institutional protocol for ICD implantation including: collection of clinical data (e.g. sex, age, heart disease, NYHA class, drug therapy, clinical evaluation) and functional assessment (i.e. transthoracic echocardiography and six minute walking test). For the specific purpose of this study, we identified a dedicated team composed of one cardiologist, one orthopedic surgeon and a kinesiology specialist who assessed at baseline (before ICD implantation) and at short/medium-term after implantation (2 weeks and 3 months respectively) the modification in terms of shoulder disability/motility, pain and QoL through different, widely adopted, scoring methods to obtain prospective quantitative data: • Numeric Rating Scale (NRS): is a 10 point scale used for evaluation of the procedure-related pain. The two extremities of the scale are the level of no pain (1 point) and the worst pain the patient could imagine (10 points). The adopted NRS was graphically delivered, with numbers enclosed in boxes. We adopted this type of scale because it is reported to be superior to verbal scales and equivalent to the well-known visual analog scale, but with respect to the last one it seems to be easier to understand for most people (not depending on clear vision, dexterity, paper, and pen) [7,8]. • Disability of the Arm, Shoulder and Hand (DASH): is a 30-item questionnaire developed by the American Academy of Orthopedic Surgeons along with the Institute for Work & Health (Toronto, Ontario, Canada). This tool was specifically created to evaluate the “…difficulty doing activities in any domain of life”. [9] DASH covers different concepts: symptoms, physical function, social function and psychological function [9,10]. • Constant Score: unlike most of the other scoring systems, this hybrid 100-point scale combines a subjective assessment including one item for pain (15 points) and one item for activities of daily living (20 points) with an objective evaluation of range of motion (forward elevation, lateral elevation, internal rotation and external rotation, 10 points each) and power (25 points). Notably, a further advantage of this method is the possibility to use the opposite shoulder as a control at each follow-up assessment [11,12]. • Short Form-36 Health Survey (SF-36): is a widely adopted questionnaire to evaluate the QoL within eight domains investigating physical and social function, emotional and physical role, bodily pain, general health, vitality and mental health. Responses are transformed to a score between 0 and 100, where a higher score represents a better QoL within that subsection. Scoring algorithms can then be applied to produce two sum- mary scores, which are commonly considered to compare QoL modifications through SF-36 survey: the physical component summary (PCS) andmental component summary (MCS) [13–17]. 2.3. Device implantation The procedures were performed by four trained electrophysiologists from our insti- tute, with similar skill in implanting cardiac devices for treating brady/tachyarrhythmias (single-chamber, dual-chamber and biventricular pacemakers/defibrillators). In particular, all patients underwent subcutaneous pre-pectoral implantation in the left side of the body (except in the case of contraindication). The device pocket was created in the left infraclavicular area within the virtual space present between the subcutaneous layer and the anterior pectoralis fascia. The pocket was created just below the left infraclavicular incision that was used for cephalic vein cutdown or subclavian vein puncture. After the transvenous placement of the appropriate lead/s (catheterization of the left cephalic vein was preferred whenever possible) and connection to the pulse-generator, the ICD was se- cured to the pre-pectoral fascia with a non-reabsorbable suture. Before ICD implantation patients received from a single operator all the information regarding the surgical proce- dure and the instructions to follow after device implantation. In particular, after the proce- dure the patients underwent a 12 h bed-rest in the ward with the suggestion of free moving of the forearm with avoidance of extreme abduction (above 90°) and extreme extrarotation of the shoulder during the following week. For patients presenting shoulder pain after ICD implantation, we prescribed as first line therapy paracetamol 1000 mg twice a day, or tramadol in case of severe symptoms; NSAID agents were not prescribed for possible interference with anticoagulants and antiplatelet drugs, which are frequently prescribed in ICD carriers. 2.4. Statistical methods The Shapiro–Wilk test was used to discriminate the presence/absence of normal distribution of the analyzed continuous variables; parametric/non-parametric statistic was adopted accordingly. Continuous variables with normal distribution are expressed as mean and standard deviation, while parameters without normal distribution are reported with median and interquartile range. Categorical variables are expressed in terms of fraction and percentages. Comparisons between baseline and post-procedure follow-up at short and medium term were performed using the paired Student's t-test or Wilcoxon test, when appropriate (the second for ordinal variables and for variables not normally distributed). Multiple logistic regression was performed for the analysis of prediction of response using variables that reached pb0.1 at univariate logistic regression analysis. p values less than 0.05 were considered significant. The present study was approved by the institutional ethics committee on human research and patients gave informed consent to participate in the study. The investiga- tion complies with the principles outlined in the 1975 Declaration of Helsinki. The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology. 3. Results 3.1. Population Fifty consecutive candidates for ICD implantation were enrolled in the study: 21 received a single chamber ICD, 5 patients received a dual-chamber device and biventricular ICD was implanted in the remaining 24; all patients were right-handed. Three patients were excluded in view of a significant shoulder impairment present before ICD implantation (the disability was caused by previous shoulder fracture in 2 and by severe scoliosis in 1 patient); no patient enrolled in the study was taking regular analgesia for other clinical condition. The device was implanted for primary prevention of sudden cardiac death in 49 patients (98%) and only one patient received the ICD after a clinical event. Table 1 depicts the characteristics of the patient population. During the follow-up period 7 patients developed a significant pocket hematoma needing close clinical follow-up and modification of anticoagulation/antiplatelet therapy. 3.2. Quality of life Table 2 shows results of QoL evaluation before and after ICD implantation for each SF-36 domain and for the two summary scores PCS andMCS.While the MCS did not present any significant modifica- tion, a significant decrease in mean PCS was present at two weeks after device implantation (41.8 vs. 44.5; t-test p=0.016), which seemed to be completely restored at the three-month follow-up (surprisingly, at this time-point PCS was above the baseline value: 46.9 vs. 44.5; t-test p=0.040). In particular the short-term decrease in PCS was mainly driven by the bodily pain domain which restored at medium term, while the later improvement was prompted by an increase in the physical role and function which also presented a decrease not reaching the significance level. 3.3. Functional evaluation • NRS: as reported in Fig. 1 our patients presented a significant increase in shoulder-related pain in the short term after device implantation, as assessed by NRS (Friedman test pb0.001; Wilcoxon test pb0.001). Pain tended to regress to baseline values in the medium term, without complete resolution (Wilcoxon p=0.080; see Fig. 1). • DASH: upper-extremity related disability, as measured by this score, had a temporal evolution that paralleled shoulder-related pain. As clearly depicted in Fig. 2, our population presented a great increase in average DASH score results in the short term with respect to baseline evaluation (median value 30.60 [interquartile range, 12.93–46.34] vs. 1.29 [interquartile range, 0.00–10.34]; Wilcoxon test pb0.001). At three months after ICD implant, patients presented a recovery toward baseline (median value 3.02 [interquartile range, 0.00–13.79] vs. 1.29 [interquartile range, 0.00–10.34]; Wilcoxon test p=0.178). • Constant Score: Fig. 3 clearly highlights a different temporal distribu- tion of Constant Score results between left and right shoulders among our population after device implantation. While right shoulders seemed to provide similar results at the three assessments (median value 96.00 [interquartile range, 91.87–98.00] at baseline vs. 93.50 [interquartile range, 90.23–98.00] 2 weeks after ICD implanta- tion vs. 96.00 [interquartile range, 91.75–98.00] three months after the procedure; Friedman p=0.239), we found a significant decrease Table 1 Baseline clinical and echocardiographic characteristics of patients. Characteristic Population (n=50) Age at implant (y) 62±12 Male [n(%)] 38 (76) Weight (kg) 75±14 Height (m) 1.7±0.9 BMI (kg/m2) 25.6±3.6 BSA ( m2) 1.88±0.23 Heart disease [n(%)] DCM 25 (50) CAD 20 (40) HCM 3 (6) Other 2 (4) NYHA class [n(%)] I–II 26 (52) III–IV 24 (48) 6MWT (m) 346±127 LVtd volume (ml) 195±64 LVts volume (ml) 138±54 LVEF (%) 31±12 SBP (mmHg) 118±16 DBP (mmHg) 73±8 HR (bpm) 65±13 Anamnestic AF [n(%)] 8 (16) Diabetes [n(%)] 10 (20) Hypertension [n(%)] 24 (48) Diuretics [n(%)] 37 (74) ARBs [n(%)] 13 (26) ACE inhibitors [n(%)] 33 (66) Beta blockers [n(%)] 47 (94) Calcium channel antagonists [n(%)] 2 (4) VKA [n(%)] 26 (52) Antiplatelets [n(%)] 26 (52) Insulin [n(%)] 5 (10) Statins [n(%)] 21 (42) PPIs [n(%)] 12 (24) Primary SCD prevention [n(%)] 49 (98) ICD type [n(%)] Single chamber 21 (42) Dual chamber 5 (10) Biventricular 24 (48) Data are expressed asmean±standard deviation or number of patients (percentage) as appropriate. ACE inhibitors, angiotensin-converting enzyme inhibitors; AF, atrial fibrillation; ARBs, angiotensin receptor blockers; BMI, body mass index; BSA, body surface area; CAD, coronary artery disease; DBP, diastolic blood pressure; DCM, dilated cardiomyopathy; EF, ejection fraction; HCM, hypertrophic cardiomyopathy; HR, heart rate; ICD, implantable defibrillator; LVtd, left ventricular telediastolic; LVts, left ventricular telesystolic; NYHA, New York Heart Association; PPIs, proton-pump inhibitors; SBP, systolic blood pressure; SCD, sudden cardiac death; VKA, vitamin K antagonists; 6MWT, six minute walk test. Table 2 Values obtained for the SF-36 domains among the enrolled patients at baseline and at short and medium term follow-up. Baseline 2 wk f-up 3 mo f-up p* p# p§ PF 71±21 67±22 76±23 ns b0.01 0.04 RP 51±43 44±40 67±36 ns b0.01 0.01 BP 81±27 72±24 81±25 0.01 0.01 ns GH 59±17 59±22 59±23 ns ns ns VT 64±19 69±19 68±21 0.02 ns ns SF 72±27 74±27 81±24 ns 0.01 b0.01 RE 65±43 65±44 67±44 ns ns ns MH 68±19 71±18 71±22 ns ns ns PCS 44±9 42±10 47±9 0.01 b0.01 0.04 MCS 47±11 49±11 48±12 ns ns ns Data are shown as the mean±SD. *, results of paired-sample t-test between baseline and two weeks follow-up; #, results of paired-sample t-test between two weeks and three months follow-up; §, results of paired-sample t-test between baseline and three months follow-up; 2 wk f-up, follow-up at two weeks; 3 mo f-up, follow-up at three months; BP, bodily pain; GH, general health; MCS, mental component summary; MH, mental health; ns, nonsignificative; PF, physical function; PCS, physical component summary; RE, role emotional; RP, role physical; SF, social functioning; VT, vitality. Fig. 1. Shoulder-related pain modification according to the NRS (Numeric Rating Scale) scale for procedure-related pain among the entire enrolled population at two weeks follow-up (2 wk f-up) and three months follow-up (3 mo f-up) after ICD implantation. 296 I. Diemberger et al. / International Journal of Cardiology 168 (2013) 294–299 in left shoulder performance in the short term (median value 76.00 [interquartile range, 61.37–86.87] vs. 95.75 [interquartile range, 91.37–98.00]; Wilcoxon test pb0.001) with a trend toward normali- zation at three months, but like NRS a borderline difference was still present in the medium term with respect to baseline (median value 95.50 [interquartile range, 83.88–98.00] vs. 95.75 [interquartile range, 91.37–98.00]; Wilcoxon test p=0.029). Notably, the short- term drop in left-shoulder performance regards all the explored sub- jective/objective domains composing the total score. However, while power, shoulder-related pain and impairment in daily living activities tended to present a higher degree of recovery in the medium term, shoulder range of motion presented some level of alteration also in the long term (Table 3). 3.4. Functional limitation predictors We performed a linear regression analysis to identify possible pre- dictors of shoulder impairment after device implantation, expressed as percentage decrease in Constant Score with respect to baseline. Only SF-36 PCS and MCS results at baseline and post-procedural pocket-hematoma proved to be independently correlated to shoulder impairment at linear multivariate regression analysis (r=0.537, p= 0.001). Considering that procedure-induced pain can represent an im- portant factor affecting shoulder impairment, we decide to perform a further (post-hoc) analysis including procedure-related pain, expressed as an increase of >/=1 point in the NRS in the short term evaluation with respect to baseline. After including post-procedural pain, the new model, which included patient age and procedure-related pain, performed significantly better (Fig. 4). In order to avoid the bias which can arise from considering a characteristic (pain) which is partially included in the target dependent variable (Constant Score), we also performed three further regression analyses which once again confirmed the importance of post-procedural pain as a Fig. 2. Upper-extremity related disability modification according to the DASH score among the entire enrolled population at two weeks follow-up (2 wk f-up) and three months follow-up (3 mo f-up) after ICD implantation. 297I. Diemberger et al. / International Journal of Cardiology 168 (2013) 294–299 predictor of short term impairment. In particular, it was the variable with the strongest association with (short-term) percentage modifi- cation in the Constant Score items of range of motion and daily activ- ities (both pb0.001, data not shown). 4. Discussion ICD implantation is the main treatment for the prevention of sud- den cardiac death in selected patients at high risk of life-threatening ventricular tachycardias. However, ICD implantation and functioning can be associated with complications, which sometimes significantly affect the patient's life. This impact tends to be higher in patients with less functional impairment like young patients and subjects af- fected by a disease without significant heart-failure manifestations Fig. 3. Comparison of Constant Score modification between right and left shoulder (nearer to the site of implantation) among the entire enrolled population at two weeks follow-up (2 wk f-up) and three months follow-up (3 mo f-up) after ICD implantation. [18]. More recently, the attention has been focused on device-recalls and device-related infections, while in the recent past inappropriate shocks represented one of the most discussed topics [19]. However, the current broadening of the indications for ICD implantation in a less impaired population can potentially raise the question of other device-related problems which can affect ICD-recipients' well-being, such as procedure-related shoulder impairment. Although some authors have already reported this problem, only one study explored this problem in a population of 50 patients after pectoral implanta- tion, a procedure which is infrequently performed today owing to device downsizing and improved surgical technique, proving a high rate of shoulder impairment. No data have ever been reported about the subcutaneous approach. In our study we demonstrated that most of the candidates for ICD implantation present significant shoulder impairment. Notably, this impairment is not confined to one or a few aspects, but all the ex- plored domains (power, range of motion, pain, daily activities, QoL) are significantly affected until at least 2 weeks after the procedure. To give an estimate of the incidence of significant shoulder impair- ment in the short term, our population showed a greater decrease in left-shoulder Constant Score than the (more conservative) intra-observer errors reported in the literature (i.e. ≥16 points) [9] in about 60% of the patients. These data are confirmed through a paired comparison of the Constant Score variation of the two shoulders: 60% and 70% of the enrolled subjects respectively presented an absolute and percentage decrease in left-shoulder Constant Score greater than the relative maximum impairment reported for the right shoulder. Moreover, about one third of these patients (>20% of the entire population) presented a similar impairment of left shoulder at three months. It should be noted that this difference was mainly driven by an impairment in range of motion, the only parameter presenting a significant alteration in the long term. Despite the methodological differences, the comparison of our re- sults with the data provided by Korte et al. in a population of patients with subpectoral ICD placement shows a faster recovery of shoulder mobility at 3 months with the subcutaneous approach. In fact, regarding shoulder range of motion, the population considered by Korte et al. showed a reduction of motility in 60% of patients at three months and 37% at six months; in our population an equivalent alteration occurred at least in 76% of patients at two weeks, but only 28% of patients still presented a similar limitation at three months. These data seem to support the idea that the use of a smaller ICD and subcutaneous placement could be associated with a reduction of functionality limitations. A new interesting result provided by our study is the role of post-procedure pain as the most important independent predictor of short-term shoulder impairment. This result stresses the importance of a good pain management not only in the first days after ICD implant, but also in the medium term for at least two weeks. The persistence of shoulder impairment that is more strictly connected with shoulder motion rather than with pain and daily ac- tivity impairment may be explained by different mechanisms: (1) a slower physiological recovery of this specific aspect which can be promoted by a lower degree of physical activity in ICD carriers, (2) a limitation derived from fear of causing problems with the ICD system or (3) a direct effect of the ICD system (device and catheters) on the shoulder. Further studies could investigate these aspects through the enrollment of different patient populations (i.e. patients who are candidates for pacemaker implant) and by the assessment of various interventions for decreasing the incidence of shoulder impairment and/or promoting its recovery. 5. Study limitations When designing the study, we adopted different methods to as- sess shoulder impairment in order to analyze the different domains image of Fig.€2 image of Fig.€3 Table 3 Variation of the specific items constituting Constant Score at baseline and at 2 weeks/3 months after ICD implantation. Left Shoulder Right Shoulder Baseline 2 wk f-up 3 mo f-up p* p# p§ Baseline 2 wk f-up 3 mo f-up p* p# p§ Pain 15 (15–15) 10 (10–15) 15 (15–15) b0.001 b0.001 0.175 15 (15–15) 15 (15–15) 15 (15–15) 0.785 0.564 0.656 ADL 20 (20–20) 13 (12–20) 20 (20–20) b0.001 b0.001 0.089 20 (20–20) 20 (20–20) 20 (20–20) 1.000 1.000 1.000 ROM 38 (36–40) 32 (26–36) 37 (34–38) b0.001 b0.001 0.001 38 (36–40) 38 (36–40) 38 (36–40) 0.446 0.841 0.253 Strength 100 (80–100) 70 (30–90) 90 (78–100) b0.001 b0.001 0.156 100 (80–100) 85 (70–100) 95 (80–100) 0.001 0.007 0.950 Data are expressed as median (interquartile range). *, results of paired-sample Wilcoxon test between baseline and two weeks follow-up; #, results of paired-sample Wilcoxon test between two weeks and three months follow-up; §, results of paired-sample Wilcoxon test between baseline and three months follow-up; 2 wk f-up, follow-up at two weeks; 3 mo f-up, follow-up at three months; ADL, activities of daily living; ROM, range of movement. 298 I. Diemberger et al. / International Journal of Cardiology 168 (2013) 294–299 that can be affected by ICD implantation. However, in order to com- bine methodological rigor with feasibility considerations we decided to adopt three of the widely adopted scoring methods including both objective and subjective information. However, like other tools, they have limitations that we tried to overcome through identifica- tion of a specialized team of investigators including one cardiologist, one orthopedic surgeon and a kinesiology specialist. Moreover, the population size can represent a limit, but it should be underlined that this is the largest study in this field and that the choice of a prospective assessment without censoring of any subject made it possible to increase the reproducibility of our results. Fig. 4. Scatter plot explaining the fitness of line-regression model including procedure-rela 6. Conclusions According to our study, ICD implantation is associated with shoulder impairment in a significant number of candidates which varies from 60% to over 75% at two weeks, according to the definition of impairment (e.g. a significant decrease in Constant Score or impairment in at least one type of movement). This impairment tends to recover within three months in the vast majority of subjects, but more than 20% pres- ent some degree of residual dysfunction mainly regarding range of motion. These data positively compare with previous results regarding subpectoral implantation, evidencing that the different surgical ted pain and patient age to predict Constant Score modification after ICD implantation. image of Fig.€4 299I. Diemberger et al. / International Journal of Cardiology 168 (2013) 294–299 technique and ICD downsizing can play a role in reducing this impair- ment. 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Circulation 2002;105:589-94. [17] Ware JE, Gandeg B, Kosinski M. The equivalence of SF-36 summary health scores estimated using standard and country-specific algorithms in 10 countries: result from the IQOLA project. J Clin Epidemiol 1998;51:1171-8. [18] Boriani G, Artale P, Biffi M, et al. Outcome of cardioverter-defibrillator implant in patients with arrhythmogenic right ventricular cardiomyopathy. Heart Vessels 2007;22:184-92. [19] Diemberger I, Martignani C, Biffi M, et al. Arrhythmia discrimination by physician and defibrillator: Importance of atrial channel. Int J Cardiol 2012;154:134-40. Implantation of cardioverter-defibrillator: Effects on shoulder function 1. Introduction 2. Methods 2.1. Eligibility criteria 2.2. Clinical and instrumental evaluation 2.3. Device implantation 2.4. Statistical methods 3. Results 3.1. Population 3.2. Quality of life 3.3. Functional evaluation 3.4. Functional limitation predictors 4. Discussion 5. Study limitations 6. Conclusions References