Change in cognitive function over 12 months among patients with an implantable cardioverter-defibrillator.

BACKGROUND: Patients with implantable cardioverter-defibrillators (ICDs) have decreased cognitive function associated with arrhythmic and/or cardiac disorders, such as ischemic cardiomyopathy. Little is known about changes in cognitive function over time among ICD patients. AIMS: The aim of this study was to evaluate baseline-to-12-month changes in cognitive function in memory (total recall and delayed recall), psychomotor speed, and executive function among ICD patients. METHODS: In this prospective study, 115 (mean [SD] age, 64.83 [9.06] years, 75% mean) and 77 ICD patients completed baseline and 12-month face-to-face interviews, respectively, which included neuropsychological tests to evaluate cognitive function. RESULTS: Patients who completed baseline and 12-month testing had decreased total and delayed recall memory (all P < .05). No significant changes from baseline to 12 months were observed in psychomotor speed (t = 0.33; P = .74) and executive function (t = -1.12; P = .27). Using 1.0 standard deviation or below the mean as a cutoff criterion, 12% to 22% of ICD patients had poor cognitive function over time. Particularly, at baseline, 17 (15%) and 15 (13%) of the 115 patients had poor memory in total and delayed recall, respectively. At 12 months, 12 (16%) and 9 (12%) of the 77 patients had poor memory in total and delayed recall, respectively. CONCLUSIONS: In this sample of patients with ICDs, memory was poor at baseline and decreased over 12 months. Future studies are indicated to determine how this change in memory influences outcomes such as medication adherence.

2022 HRS expert consensus statement on evaluation and management of arrhythmic risk in neuromuscular disorders.

This international multidisciplinary document is intended to guide electrophysiologists, cardiologists, other clinicians, and health care professionals in caring for patients with arrhythmic complications of neuromuscular disorders (NMDs). The document presents an overview of arrhythmias in NMDs followed by detailed sections on specific disorders: Duchenne muscular dystrophy, Becker muscular dystrophy, and limb-girdle muscular dystrophy type 2; myotonic dystrophy type 1 and type 2; Emery-Dreifuss muscular dystrophy and limb-girdle muscular dystrophy type 1B; facioscapulohumeral muscular dystrophy; and mitochondrial myopathies, including Friedreich ataxia and Kearns-Sayre syndrome, with an emphasis on managing arrhythmic cardiac manifestations. End-of-life management of arrhythmias in patients with NMDs is also covered. The document sections were drafted by the writing committee members according to their area of expertise. The recommendations represent the consensus opinion of the expert writing group, graded by class of recommendation and level of evidence utilizing defined criteria. The recommendations were made available for public comment; the document underwent review by the Heart Rhythm Society Scientific and Clinical Documents Committee and external review and endorsement by the partner and collaborating societies. Changes were incorporated based on these reviews. By using a breadth of accumulated available evidence, the document is designed to provide practical and actionable clinical information and recommendations for the diagnosis and management of arrhythmias and thus improve the care of patients with NMDs.

Electrocardiographic abnormalities and sudden death in myotonic dystrophy type 1.

BACKGROUND: Sudden death can occur as a consequence of cardiac-conduction abnormalities in the neuromuscular disease myotonic dystrophy type 1. The determinants of the risk of sudden death remain imprecise. METHODS: We assessed whether the electrocardiogram (ECG) was useful in predicting sudden death in 406 adult patients with genetically confirmed myotonic dystrophy type 1. A patient was characterized as having a severe abnormality if the ECG had at least one of the following features: rhythm other than sinus, PR interval of 240 msec or more, QRS duration of 120 msec or more, or second-degree or third-degree atrioventricular block. RESULTS: Patients with severe abnormalities according to the entry ECG were older than patients without severe abnormalities, had more severe skeletal-muscle impairment, and were more likely to have heart failure, left ventricular systolic dysfunction, or atrial tachyarrhythmia. Such patients were more likely to receive a pacemaker or an implantable cardioverter-defibrillator during the follow-up period. During a mean follow-up period of 5.7 years, 81 patients died; there were 27 sudden deaths, 32 deaths from progressive neuromuscular respiratory failure, 5 nonsudden deaths from cardiac causes, and 17 deaths from other causes. Among the 17 patients who died suddenly in whom postcollapse rhythm was evaluated, a ventricular tachyarrhythmia was observed in 9. A severe ECG abnormality (relative risk, 3.30; 95% confidence interval [CI], 1.24 to 8.78) and a clinical diagnosis of atrial tachyarrhythmia (relative risk, 5.18; 95% CI, 2.28 to 11.77) were independent risk factors for sudden death. CONCLUSIONS: Patients with adult myotonic dystrophy type 1 are at high risk for arrhythmias and sudden death. A severe abnormality on the ECG and a diagnosis of an atrial tachyarrhythmia predict sudden death. (ClinicalTrials.gov number, NCT00622453.)

Pacemaker and implantable cardioverter-defibrillator use in a US myotonic dystrophy type 1 population.

INTRODUCTION: We assessed implant rates, indications, characteristics, and outcomes in patients with the neuromuscular disease, myotonic dystrophy type 1 (DM1) receiving a pacemaker or an implantable cardioverter-defibrillator (ICD). METHODS AND RESULTS: Device use was evaluated in a prospective, multicenter registry of 406 genetically confirmed adult patients followed for 9.5 ± 3.2 years. Forty-six (11.3%) had or received a pacemaker and 21 (5.2%) received an ICD. Devices were primarily implanted for asymptomatic conduction abnormalities and left ventricular (LV) systolic dysfunction. However, 7 (15.2%) pacemakers were implanted for third-degree atrioventricular block and 6 (28.6%) ICDs were implanted for ventricular tachyarrhythmias (ventricular tachycardia [VT] or fibrillation [VF]). Patients receiving devices were older and more frequently had heart failure, LV systolic dysfunction, atrial tachyarrhythmias, and ECG conduction abnormalities compared to nondevice patients. Five (10.9%) pacemaker patients underwent upgrade to an ICD, 3 for LV systolic dysfunction, 1 for VT/VF, and 1 for progressive conduction disease. Seventeen (27.4%) of the 62 patients with devices were pacemaker-dependent at last follow-up. Three (14.3%) ICD patients had appropriate therapies. Twenty-four (52.2%) pacemaker patients died including 13 of respiratory failure and 7 of sudden death. Seven (33.3%) ICD patients died including 2 of respiratory failure and 3 of sudden death. The patients with ICDs and sudden death all had LV systolic dysfunction and 1 death was documented due to inappropriate therapies. CONCLUSIONS: DM1 patients commonly receive antiarrhythmia devices. The risk of VT/VF and sudden death suggests that ICDs rather than pacemakers should be considered for these patients.

Survival and CTG repeat expansion in adults with myotonic dystrophy type 1.

INTRODUCTION: An association is observed between the severity of myotonic dystrophy type 1 (DM1) and the genetic abnormality of cytosine-thymine-guanine (CTG) repeat expansion. It is unknown whether an association exists between survival and CTG repeat expansion. METHODS: In an adult 406-patient DM1 cohort, the phenotype, including survival age, was evaluated in relation to CTG repeat expansion. RESULTS: At study entry, age was 42 ± 12 (range 18-78) years, with a CTG repeat length of 629 ± 386 (range 54-1965). An inverse correlation was observed between CTG repeat length and the age at onset and younger DM1 phenotype. Over a follow-up of 9.2 ± 3.1 years, 118 (29.1%) patients died, including 60 of neuromuscular respiratory failure, 41 of cardiac causes, and 17 of non-neuromuscular, non-cardiac causes. There was an inverse relationship between all-cause survival and CTG length (relative risk 5.4 per log repeat, 95% confidence interval 2.9-10.2, P < 0.001). CONCLUSION: The data demonstrate a genotype-mortality association in DM1.

Increased mortality with left ventricular systolic dysfunction and heart failure in adults with myotonic dystrophy type 1.

BACKGROUND: Myotonic dystrophy type 1 (DM1) is a neurologic disorder with known cardiac involvement, including left ventricular systolic dysfunction (LVSD), heart failure (HF), atrioventricular and intraventricular conduction system disease, and sudden death. We studied the prevalence of these conditions and associated findings in a large population with DM1. METHODS: History, physical examination, genetic testing, and electrocardiography were performed on 406 patients with DM1, and cardiac imaging was performed on 180 (44.3%) of these patients. RESULTS: Left ventricular systolic dysfunction and clinical HF were found in 34 (18.9%) of 180 and in 23 (5.7%) of 406 of enrolled subjects, respectively, yielding an overall prevalence of LVSD/HF in 41 (10.1%) of 406. Increasing age, male sex, electrocardiographic conduction abnormalities, presence of atrial and ventricular arrhythmias, and implanted devices were all significantly associated with LVSD/HF, whereas cytosine-thiamine-guanine repeat length and neuromuscular severity score were not. The interval≥240 milliseconds (relative risk 4.1, 95% CI 1.7-9.6, P=.001) and QRS duration≥120 milliseconds (relative risk 4.2, 95% CI 2.0-8.5, P<.001) were significant predictors of LVSD/HF. The presence of LVSD/HF was also significantly associated with all-cause death (relative risk 3.9, 95% CI 2.3-6.4, P<.001) and cardiac death (relative risk 5.7, 95% CI 2.6-12.4, P<.001). CONCLUSIONS: A significant prevalence of LVSD/HF exists in patients with DM1. The presence of LVSD/HF in DM1 is significantly associated with all-cause and cardiac death.

Clinical Care Recommendations for Cardiologists Treating Adults With Myotonic Dystrophy.

Myotonic dystrophy is an inherited systemic disorder affecting skeletal muscle and the heart. Genetic testing for myotonic dystrophy is diagnostic and identifies those at risk for cardiac complications. The 2 major genetic forms of myotonic dystrophy, type 1 and type 2, differ in genetic etiology yet share clinical features. The cardiac management of myotonic dystrophy should include surveillance for arrhythmias and left ventricular dysfunction, both of which occur in progressive manner and contribute to morbidity and mortality. To promote the development of care guidelines for myotonic dystrophy, the Myotonic Foundation solicited the input of care experts and organized the drafting of these recommendations. As a rare disorder, large scale clinical trial data to guide the management of myotonic dystrophy are largely lacking. The following recommendations represent expert consensus opinion from those with experience in the management of myotonic dystrophy, in part supported by literature-based evidence where available.

Physical function of patients with implantable cardioverter-defibrillators.

BACKGROUND: Patients with implantable cardioverter-defibrillators (ICDs) face problems in physical function, but little is known about how mastery predicts physical function over time. PURPOSE: The primary purpose of this study was to examine the influence of mastery (assessed at baseline) on physical function (observed distance walked and perceived function) over 12 months among ICD patients. Secondary purposes were to (1) examine the influence of aging, in interaction with mastery, on physical function and (2) determine predictors of 12-month physical function. METHODS: The ICD patients (N = 122; 75% men; 88% white; mean age, 65 years) completed the baseline interviews; 100 patients completed the 12-month interviews. Repeated-measures 1-way analyses of variance were used to examine the influence of mastery and the interaction of mastery and aging on physical function over 12 months. Multiple regression analyses were conducted to determine predictors of 12-month physical function. RESULTS: The ICD patients with higher mastery had better walk distances than those with lower mastery; and walk distances were improved over 12 months, but only in those with lower mastery (F = 5.40, P = .02). The ICD patients with higher mastery had better perceived physical function than those with lower mastery (F = 25.57, P < .0001), but those with both lower and higher mastery did not show significant improvement. Neither significant interaction of aging and mastery on physical function nor predictors of walk distances were found. Baseline depression significantly predicted 12-month perceived physical function (F = 8.94, P = .0042). CONCLUSIONS: The ICD patients with lower mastery had considerable impairments in physical function compared with those with higher mastery over time. Depression is more likely to predict perceived physical function. Further prospective studies are needed to validate these findings in a larger sample and develop interventions to improve physical impairment in ICD patients.

Consensus-based care recommendations for adults with myotonic dystrophy type 1.

PURPOSE OF REVIEW: Myotonic dystrophy type 1 (DM1) is a severe, progressive genetic disease that affects between 1 in 3,000 and 8,000 individuals globally. No evidence-based guideline exists to inform the care of these patients, and most do not have access to multidisciplinary care centers staffed by experienced professionals, creating a clinical care deficit. RECENT FINDINGS: The Myotonic Dystrophy Foundation (MDF) recruited 66 international clinicians experienced in DM1 patient care to develop consensus-based care recommendations. MDF created a 2-step methodology for the project using elements of the Single Text Procedure and the Nominal Group Technique. The process generated a 4-page Quick Reference Guide and a comprehensive, 55-page document that provides clinical care recommendations for 19 discrete body systems and/or care considerations. SUMMARY: The resulting recommendations are intended to help standardize and elevate care for this patient population and reduce variability in clinical trial and study environments.

Characteristics of volunteers responding to emergencies in the Public Access Defibrillation Trial.

OBJECTIVES: To evaluate the characteristics of volunteers responding to emergencies in the North American Public Access Defibrillation (PAD) Trial. METHODS: The PAD Trial was a prospective evaluation of cardiac arrest survival in community facilities randomized to cardiopulmonary resuscitation (CPR) or to CPR with automated external defibrillators (AEDs). The PAD volunteers' characteristics were analyzed using Poisson regression clustered on the facility and offset by the number of emergency episodes to which volunteers were exposed. RESULTS: A total of 19,320 volunteers in 1260 facilities were trained to provide emergency care. Of these, 8169 volunteers were participating actively at their facility during a time when one or more emergency episodes occurred. There were 1971 emergency episodes responded to by 1245 volunteers. The treatment arm (CPR-only versus CPR+AED) was not associated with the likelihood of volunteer participation in an episode. Likewise, the volunteers' age or sex did not affect response. Volunteers more likely to respond were supervisory/management or security personnel, non-minority participants, volunteers with previous CPR training, volunteers with previous experience in emergency care and those who passed the PAD CPR skills follow-up test. Volunteers who had a formal education beyond a high school level were less likely to respond. CONCLUSIONS: Volunteers with previous emergency training and positions of responsibility in their facility had a greater likelihood of participation in medical emergencies in the PAD Trial.

Utility of Conventional Electrocardiographic Criteria in Patients With Idiopathic Ventricular Tachycardia.

OBJECTIVES: This study sought to determine the ability of conventional electrocardiographic (ECG) criteria to correctly differentiate idiopathic ventricular tachycardia (VT) from supraventricular tachycardia (SVT) with aberrancy. BACKGROUND: Previously reported VT ECG criteria were developed from cohorts of patients with structural heart disease and have not been applied to patients with idiopathic VT. METHODS: ECGs of 115 idiopathic VTs, 101 post-myocardial infarction (MI) VTs, and 111 wide QRS SVTs were analyzed using standard criteria. VT was diagnosed in patients when at least 1 criterion was met, SVT when no criteria were met, and indeterminate when there were conflicting criteria. RESULTS: Standard ECG criteria more frequently diagnosed VT in the post-MI group than the idiopathic group (95% vs. 82%, respectively; p < 0.01). Diagnosis in only 12 of the 111 SVT patients (11%) met the criteria for VT. All patients in the idiopathic VT group with right branch bundle block morphology who did not meet VT criteria demonstrated an rsR' pattern in V1 (consistent with SVT). Among idiopathic VT patients, Purkinje-associated VT had the lowest sensitivity for correct VT diagnosis in 13 of 23 patients (57%), septal sites of origin were correctly diagnosed in only 56 of 76 patients (74%), whereas nonseptal sites had a high sensitivity in 35 of 35 patients (100%; p < 0.005). CONCLUSIONS: Conventional ECG criteria have reduced sensitivity to distinguish VT from SVT with aberrancy in patients with idiopathic VT. This is most pronounced in VT originating from septal sites, particularly Purkinje sites and the septal outflow tract regions. Clinicians should be aware that application of conventional ECG criteria in idiopathic VT may underdiagnose VT.

Thoracic spinal cord stimulation reduces the risk of ischemic ventricular arrhythmias in a postinfarction heart failure canine model.

BACKGROUND: Thoracic spinal cord stimulation (SCS) is a promising therapy in treating refractory angina. This study was designed to investigate SCS with regard to the risk of arrhythmias during myocardial ischemia and its cardiac electrophysiological effects. METHODS AND RESULTS: We studied 22 dogs with healed anterior myocardial infarction (MI) and superimposed heart failure (HF) induced by rapid ventricular pacing. SCS was applied at the dorsal T1-T2 segments of the spinal cord (at 50 Hz, 0.2 ms) for 15 minutes. Transient (2-minute) myocardial ischemia was induced on 2 separate occasions (no SCS and SCS) to provoke ventricular arrhythmias (ventricular tachycardia/ventricular fibrillation; VT/VF). Ischemic episodes were separated by 90 minutes, and dogs were randomly assigned to receive SCS or no SCS before the first or second ischemic episode. SCS reduced the occurrence of VT/VF from 59% to 23% when SCS was applied during transient myocardial ischemia (odds ratio, 0.36; 95% confidence interval, 0.1626 to 0.5646; P=0.0009). SCS also decreased sinus rate by 7.5+/-14 bpm (P=0.048), increased the PR interval by 11.1+/-14.7 ms (P=0.009), and reduced systolic blood pressure by 9.8+/-13.6 mm Hg (P=0.02). CONCLUSIONS: Thoracic SCS appears to protect against ischemic VT/VF in a canine model of healed MI and HF. SCS reduced sinus rate and systolic blood pressure, changes consistent with the previously known antisympathetic effect of SCS, which may have contributed to the antiarrhythmic benefits.

Adverse events associated with lay emergency response programs: the public access defibrillation trial experience.

UNLABELLED: The adverse event (AE) profile of lay volunteer CPR and public access defibrillation (PAD) programs is unknown. We undertook to investigate the frequency, severity, and type of AE's occurring in widespread PAD implementation. DESIGN: A randomized-controlled clinical trial. SETTING: One thousand two hundred and sixty public and residential facilities in the US and Canada. PARTICIPANTS: On-site, volunteer, lay personnel trained in CPR only compared to CPR plus automated external defibrillators (AEDs). INTERVENTION: Persons experiencing possible cardiac arrest receiving lay volunteer first response with CPR+AED compared with CPR alone. MAIN OUTCOME MEASURE: An AE is defined as an event of significance that caused, or had the potential to cause, harm to a patient or volunteer, or a criminal act. AE data were collected prospectively. RESULTS: Twenty thousand three hundred and ninety six lay volunteers were trained in either CPR or CPR+AED. One thousand seven hundred and sixteen AEDs were placed in units randomized to the AED arm. There were 26,389 exposure months. Only 36 AE's were reported. There were two patient-related AEs: both patients experienced rib fractures. There were seven volunteer-related AE's: one had a muscle pull, four experienced significant emotional distress and two reported pressure by their employee to participate. There were 27 AED-related AEs: 17 episodes of theft involving 20 devices, three involved AEDs that were placed in locations inaccessible to the volunteer, four AEDs had mechanical problems not affecting patient safety, and three devices were improperly maintained by the facility. There were no inappropriate shocks and no failures to shock when indicated (95% upper bound for probability of inappropriate shock or failure to shock = 0.0012). CONCLUSIONS: AED use following widespread training of lay-persons in CPR and AED is generally safe for the volunteer and the patient. Lay volunteers may report significant, usually transient, emotional stress following response to a potential cardiac arrest. Within the context of this prospective, randomized multi-center study, AEDs have an exceptionally high safety profile when used by trained lay responders.

Factors associated with poor survival in women experiencing cardiac arrest in a rural setting.

OBJECTIVES: The purpose of this study was to determine whether gender differences exist in the characteristics and outcomes for out-of-hospital cardiac arrest (OHCA) occurring in a rural setting. BACKGROUND: In urban settings, women have a lower incidence of OHCA than men but otherwise a comparable survival for ventricular fibrillation (VF) OHCA. Whether OHCA gender differences exist in rural settings is not clear. METHODS: The study consisted of a prospective collection and analysis of nontraumatic, adult OHCA prompting a 911 call in six rural Indiana counties. RESULTS: Over an average period of 2.2 years, 138 women and 250 men experienced OHCA (annual incidence rate: 56.4 per 100,000 men and 29.3 per 100,000 women). Women were older, less likely to experience OHCA in a public setting, more likely to be in an extended care facility, and less likely to have a witnessed arrest than were men. Women were less likely to present with an initial rhythm of VF than men (33.3% vs 53.6%, P < .001). Women in VF had a longer time interval from 911 call to first shock compared with men. Women had poorer survival to hospital discharge for all OHCA (2.2% vs 7.2%, P = .04) and VF OHCA (2.2% vs 13.4%, P = .05) compared with men. After age adjustment, female gender remained associated with a poorer OHCA survival outcome. With adjustment for all significant arrest characteristics, female gender was no longer associated with survival. CONCLUSIONS: In a rural population, women suffering OHCA have a dismal survival rate likely because of multiple unfavorable arrest characteristics.

Ischemic ventricular arrhythmias during heart failure: a canine model to replicate clinical events.

BACKGROUND: Development of experimental animal models has played an invaluable role in understanding the mechanisms of ventricular arrhythmias. OBJECTIVES: The purpose of this study was to evaluate a new canine model of myocardial infarction (MI), heart failure, and ischemic ventricular arrhythmias in an attempt to replicate clinical conditions. METHODS: Thirty-six mongrel dogs underwent placement of a permanent ventricular pacemaker and induction of an anterior MI by percutaneous transcatheter embolization of polyvinyl foam particles into the left anterior descending coronary artery (just distal to the first septal branch). After a 2-week recovery period, heart failure was induced by continuous rapid ventricular pacing at 200 to 240 ppm for 3 weeks. Transient (4-minute) myocardial ischemia was induced via balloon occlusion of the proximal left circumflex coronary artery. Echocardiographic and electrophysiologic testing was performed before MI creation and repeated prior to acute ischemia induction. RESULTS: Seven dogs (19%) died within several hours of MI creation. All surviving dogs developed severe left ventricular systolic dysfunction. Significant increases in the intraatrial and intraventricular conduction intervals were observed following MI creation and heart failure induction compared with baseline values, as evidenced by increases in the duration of the P wave and QRS complex. Significant increases in corrected QT interval and ventricular refractoriness were observed. Acute transient ischemia induced sustained ventricular tachycardia or ventricular fibrillation in 21 of 29 dogs (72%). CONCLUSION: This canine model can serve as a useful tool for studying ventricular arrhythmias during the interactions of healed infarction, heart failure, increased sympathetic tone, and myocardial ischemia.

Intrathecal clonidine reduces the incidence of ischemia-provoked ventricular arrhythmias in a canine postinfarction heart failure model.

BACKGROUND: Intrathecal clonidine (ITC) is used clinically to manage neuropathic pain but frequently causes hypotension and bradycardia due to centrally mediated sympatholytic effects. OBJECTIVES: The purpose of this study was to evaluate the cardiac electrophysiologic effects of thoracic ITC and its effects on ischemia-provoked ventricular arrhythmias. METHODS: Twelve mongrel dogs with healed myocardial infarctions and heart failure were evaluated. ITC was delivered locally via catheter to the T2-T4 spinal segments and was dosed to reduce heart rate (HR) by >20% to 25%. Electrophysiologic testing was performed before and after ITC. Transient (4-minute) myocardial ischemia was induced via left circumflex coronary artery occlusion on two separate occasions to provoke ventricular arrhythmias (ventricular tachycardia [VT]/ventricular fibrillation [VF]). Ischemic episodes were separated by 1 to 2 days, and dogs were randomly assigned to receive ITC or intrathecal saline flush (control) prior to the first or the second ischemic episode. RESULTS: ITC produced significant decrease in HR (31%) and increases in PR interval (22%), Wenckebach cycle length (122%), and atrial and ventricular effective refractory periods (19% and 9%, respectively) but had no significant effect on systemic blood pressure. The occurrence of VT/VF was reduced from 9 of 12 to 3 of 12 dogs when ITC was administered prior to transient myocardial ischemia (P = .04). ITC also blunted ischemia-induced HR increase by 74%. CONCLUSION: ITC reduced ischemia-induced VT/VF in a canine model of healed myocardial infarction with superimposed heart failure and acute ischemia. Results from electrophysiologic testing were consistent with a clonidine-induced reduction in cardiac sympathetic activity from the spinal cord. These data suggest that ITC administration may be a novel approach to treating ventricular arrhythmias.

Arrhythmias in the muscular dystrophies.

In patients with muscular dystrophies, cardiac involvement leading to cardiomyopathy and arrhythmias occurs with variable prevalence, mirroring the phenotypic variability seen among and within the various hereditary myopathies. Knowledge of the incidence of arrhythmias and predictors of sudden death in the various hereditary myopathies can help guide screening and appropriate management of these patients, thereby improving survival. The noncardiac manifestations can lead to delayed recognition of symptoms, affect the decision to implant a prophylactic device, and once a decision is made to proceed with device implant, increase peri-procedural respiratory and anesthesia-related complications.