Cardiac Rhythm Management Device Implantation Research Articles

P1467Ambulatory implantation of cardiac rhythm management devices: a retrospective safety and cost-minimization analysis in a developing country

Abstract Introduction The monetary costs and safety of ambulatory implantation of cardiac rhythm management devices (CRMD) has been previously studied in many developed countries, but few of these analyses come from developing countries. Here we present a summary of complications and comparative costs of ambulatory implantation of CRMDs sourced from a set of cases logged in a large database of a public facility from a developing country, over a period of 6 years. Purpose To determine the number and type of complications in ambulatory implantation of CRMDs and to perform a cost-minimization analysis of the outpatient versus the implantation with hospital admission. Methods We performed a retrospective study using the database of CRMDs that included implantation procedures of unicameral (UNI) and bicameral (BI) pacemakers, implantable cardiac defibrillators (ICD) and generator replacements (RPL) from September 2012 to December 2018, in order to determine the number of patients that received the device in ambulatory and hospitalization regimens. Then, we reviewed the medical records to determine the complication rate during the first month in both modalities. Finally, we compared the ambulatory implant costs, including hospital day-care, against the costs of a two-day hospitalization, one of these being spent in an intermediate-care unit and the other in general hospitalization. Results We identified a total of 541 procedures; mean age 70 ± 14 years; 227 (42%) female patients. From these, 361 were ambulatory (66,7%), 45% being BI implantation, 38% RPL, 9% UNI implantation and 8% ICD implantation. Of this, 81% of the procedures were for AV block, 7% for sinus node dysfunction and 12% for sudden death prevention (primary or secondary). There were a significant lower number of complications in the ambulatory group (3,9%, n = 14) compared with the hospitalization group (11,6%, n = 15) p = 0,006 (X²) , with no CRMDs emergencies, fatal complications or emergency readmissions in either group. Complications included pneumothorax, deep venous thrombosis, endocarditis, lead displacement and local hematoma. The cost of an ambulatory CRMD implantation was 65 USD whereas the same procedure with hospital admission was 675 USD, according with the payment units valid for our country. Conclusion Ambulatory implantation of all CRMDS is feasible and safe. This modality implies a significant monetary saving that directly benefits the patients and the social security system. It can be done in a tertiary level hospital that can reach the whole quality standards for these interventions.

Effect of early pendulum exercise on shoulder function after cardiac rhythm management device implantation.

Patients who are post-implantation of cardiac rhythm management devices (CRMDs) are commonly instructed to restrict ipsilateral arm movement to reduce risk of lead dislodgement. This immobilization practice increases risk of shoulder-related pain leading to limited shoulder function. We aimed to assess effect of pendulum exercise on shoulder function in patients after CRMD implantation. This study was a prospective, randomized, open-blinded end point study conducted with 200 patients undergoing CRMD implantation. They were randomized into two groups, standard care (control) and pendulum exercise (experimental) groups. The shoulder function was assessed using QuickDASH-TH scores and measurement of the range of motion (ROM) of shoulder abduction and flexion before and 1month after implantation. Baseline characteristics did not differ between the two groups. The lower incidence of shoulder ROM reduction after CRMD implantation was demonstrated in the pendulum exercise group compared to the control group in both flexion (16.8% vs. 40.4%, P < 0.001) and abduction (9.9% vs. 32.3%, P < 0.001). A lower disability of shoulder function after implantation assessed by QuickDASH-TH scores was also noted in the exercise group compared to control (15.2 ± 16.4 vs. 23.4 ± 18.1, P = 0.001). Two patients in the control group and one in the exercise group had atrial lead dislodgement on the day following the procedure. Early pendulum exercise with ipsilateral arm after CRMD implantation was safe and resulted in lower incidence of limited shoulder ROM and less disability of shoulder function compared to control group. The study was registered in clinicaltrials.in.th , and the identification number is TCTR20180612003.

Electrical Interaction between Implantable Vagus Nerve Stimulation Device and Implantable Cardiac Rhythm Management Device.

Autonomic regulation therapy via vagus nerve stimulation (VNS) was recently approved as a therapy for chronic heart failure, and will likely be utilized in patients who are also indicated for cardiac rhythm management device implantation. This study is designed to assess the degree to which VNS is likely to cause interference in the cardiac sensing of an implantable cardiac rhythm management device. A VNS stimulation lead and a cardiac sensing lead were placed in a simulated biological medium. A nonconductive carrier frame was used to position the leads at a precise electrode spacing. Stimulation was delivered through the VNS Therapy lead at a maximum output current and a variety of combinations of stimulation frequencies from 5-30 Hz and stimulation pulse widths from 130-1000 μs. The electrode spacing began at 0 cm and was increased in 1 cm increments until the measured signal dropped below the cardiac rhythm management device noise floor for sensing. The test was conducted with both bipolar and unipolar sensing. In the bipolar sensing configuration, the maximum sensed signal amplitude was 687 μV at an electrode separation of 0 cm, signal frequency of 30 Hz, pulse width of 1000 μs, and output current of 3.5 mA. In the unipolar sensing configuration, the maximum amplitude was 406 μV. In both configurations, the measured signal with maximum stimulation intensity decreased significantly with electrode separation, and dropped below the noise floor at an electrode spacing of 3.0 cm. The sensed signal amplitude was further attenuated at lower stimulation amplitudes and pulse widths. Even at maximum neural stimulation intensity of 3.5 mA, at an electrode separation of at least 3.0 cm, neural stimulation did not result in a detectable level of interference with either bipolar or unipolar sensing. Because this separation is significantly smaller than the minimum electrode separation of 15 cm in clinical practice, VNS Therapy is not expected to interfere with the function of implantable cardiac devices.

Pneumothorax as a complication of cardiac rhythm management devices implantation

Introduction/Objective. Pneumothorax is one of the most common complications of cardiac rhythm management (CRM) devices implantation. We aimed to assess the incidence of pneumothorax after implantation of these devices and to determine risk factors for this complication. Methods. A retrospective, observational study included patients in whom CRM devices were implanted, pacing system was upgraded, or lead revision was performed during 2012 at the Pacemaker Center, Clinical Center of Serbia. We determined the connection between different variables, including sex, age, type of implanted device, prior history of chronic obstructive pulmonary disease, operator experience, venous access, the use of intravenous contrast during procedure, and the development of pneumothorax as the procedure-related complication, using multiple logistic regression. Results. A total of 999 patients were included in this study. The patients? mean age was 68.1 ?} 9.2 years; 665 (66.6%) patients were male. The incidence of pneumothorax was 1.8% and an invasive treatment of this complication was required in 13 (72.2%) patients. Pneumothorax was more frequent in women (B = -2.136, p = 0.015), in patients with age &gt; 75 years (B = 4.315, p = 0.001), venous access with subclavian vein puncture (B = 2.672, p = 0.045), and use of intravenous contrast during procedure (B = 3.155, p = 0.007). Conclusion. Pneumothorax is a relatively rare complication of CRM device implantation, and for reducing its incidence, cephalic vein cut-down should be preferred to subclavian or axillary vein puncture as venous access, axillary vein puncture should not be avoided when cephalic vein cannot be found or used, and in the case of difficult vein puncture, contrast venography should be done immediately, before risky punctures.

Complications Related to Cardiac Rhythm Management Device Therapy and Their Financial Implication: A Prospective Single-Center Two-Year Survey

Cardiac rhythm management devices (CRMDs) have proven their clinical effectiveness for patients with heart rhythm disorders. Little is known about safety and complication rates during the implantation of these devices. This study demonstrated the complication rates related to CRMD implantation, and estimated the additional hospital stay and cost associated with the management of complications. During a period of one year, a total of 464 consecutive recipients underwent CRMD implantation and were followed for 2 years. Finally, data were analyzed for 398 patients who completed the two-year follow up, resulting in a total of 796 patient-years. Of the 201 patients with initial pacemaker (PM) implantations, 6 (2.99%) had seven complications (5 patients had lead dislodgement, 1 of them twice), and 1 patient developed pocket infection. Of the 117 PM replacements, 1 (0.85%) patient developed a complication (pocket erosion). Two patients with complications (1 with an initial PM and 1 with a replacement) died before completing the follow up for reasons unrelated to cardiac causes. There were no complications in either initial implantations (69 patients) or replacements (11 patients) of implantable cardioverter-defibrillators. The average prolongation of the hospital stay was 7 days, ranging from 1 to 35 days, resulting in 17,411 of total additional direct hospital costs. This study found relatively low rates of complications in patients undergoing CRMD implantation, initial or replacement, in our center, compared with other studies. The additional hospitalization days and costs attributable to these complications depend on the nature of the complication.

Predictors of pocket hematoma in patients on antithrombotic therapy undergoing cardiac rhythm device implantation: insights from the FinPAC trial

Background. The FinPAC trial showed that the strategy of uninterrupted oral anticoagulation (OAC) was non-inferior to interrupted OAC for the primary outcome of bleeding and thromboembolic complications in patients undergoing cardiac rhythm management device (CRMD) implantation.Methods. We conducted a post hoc analysis of the FinPAC data to explore the incidence and predictors of significant (> 100 cm2) pocket hematoma after CRMD implantation among the study population (n = 447). A total of 213 patients were on OAC, 128 were on aspirin, and 106 on no antithrombotic therapy.Results. The incidence of significant pocket hematoma during hospital stay was significantly higher among patients using OAC (5.6%) and aspirin (5.5%) than in those with no antithrombotic medications (0.9%), but only one patient (0.8%) in the aspirin group needed revision of hematoma. Two patients (0.9%) in the OAC group and one (0.8%) in the aspirin group needed blood products. In multivariable regression analysis, no pre- procedural features predicted the significant hematoma in any of the groups.Conclusions. Clinically significant pocket hematoma is a rare complication after CRMD implantation in patients with ongoing therapeutic OAC. The incidence of significant pocket hematoma formation is similar in patients using OAC and those using aspirin.Trial registration: ClinicalTrials.gov identifier: NCT00479362.

PCV99 - Procedure (Implantation) Cost And Total Hospitalization Cost Of Patients Subjected To Cardiac Rhythm Management Devices Implantation: Results From A Single Tertiary Centre

PCV99 - Procedure (Implantation) Cost And Total Hospitalization Cost Of Patients Subjected To Cardiac Rhythm Management Devices Implantation: Results From A Single Tertiary Centre

Abstract 19093: Paradoxical Improvement of Tricuspid Valve Incompetence Severity Following Implantation of Ventricular Leads

Background: Cardiac rhythm management devices (CRMD) require an endocardial ventricular lead to be placed across the tricuspid valve. Worsening tricuspid regurgitation (TR) with implantation of CRMD has been described. We report the incidence of improvement in TR after CRMD placement, which is an unexpected finding. Methods: We retrospectively reviewed 148 patients (age 68±15) that received a CRMD. TR, ejection fraction (EF) and pulmonary artery systolic pressure (PASP) measured by Doppler echocardiography before and after CRMD implantation were analyzed. The TR was graded according to the degree of severity as mild, moderate and severe. A scale of 0-4 according to the grade of severity was used. Improvement in the severity of TR was classified corresponding with the reduction in grades of severity of TR as follows: minimal (&lt;1grade), slight (1), and significant reduction (≥2). Results: Mean follow-up time was 30±12 months. Thirty-nine (26%) patients experienced improvement in the severity of TR (from 1.7±0.8 to 0.9±0.7; p=0.0001-5) after placement of a CRMD. The remaining 109 patients had an increase in the severity of TR (from 0.1±0.5 to 1.4±0.9; p=0.0005-10). Reduction in TR was associated with improvement in EF (from 41±19 to 47±14%; p=0.01) and PASP (from 45±15 to 36±14mmHg; p=0.002-2). Patients that had increase in TR did not have a significant change in their EF (from 40±17 to 42±15%; p=0.07) and had worsening of their PASP (from 38±14 to 42±16mmHg; p=0.002). Evaluation of improvement in TR per type of device implanted revealed no difference between patients who received pacemakers (PPM), defibrillators (ICD) or cardiac resynchronization therapy devices (CRT) (ICD/CRT vs PPM p=0.12; ICD vs PPM p=0.22; ICD vs CRT p=0.29 and CRT vs PPM p=0.07). Conclusion: Severity of TR may improve in some patients after CRMD placement. This could be attributed to diuresis and optimization of medical therapy at the time of CRM implant or restoration of AV synchrony with pacing, as evidenced by the reduction in PASP and improved EF among those patients.

PCV17 - Cost-Of-Illness Study of Patients Subjected to Cardiac Rhythm Management Devices Implantation: Results from a Single Tertiary Centre

PCV17 - Cost-Of-Illness Study of Patients Subjected to Cardiac Rhythm Management Devices Implantation: Results from a Single Tertiary Centre

Clinical significance of increased tricuspid valve incompetence following implantation of ventricular leads

Cardiac rhythm management devices (CRMD) require a ventricular lead to be placed across the tricuspid valve. Tricuspid regurgitation (TR) is an under-recognized clinical complication of lead implantation and its clinical significance is unknown. We studied the incidence of hospitalizations for congestive heart failure (CHF) exacerbation among patients with worsening TR after ventricular lead implantation. We reviewed 148 patients (age 68 ± 15) that received a CRMD. TR and pulmonary artery systolic pressure (PASP) measured by Doppler echocardiography before and after CRMD implantation were analyzed. Hospitalizations for CHF exacerbation post-implantation were counted. Follow-up was 32 ± 14 months. Ninety-nine (67%) patients had no change, 24 (16%) slight, and 9 (6%) significant increase in TR after CRMD implantation, while 13 (9%) patients had slight and 3 (2%) significant improvement. Patients with a significant increase in TR had higher incidence of hospitalizations (1.7 ± 0.5) compared to patients with slight (0.8 ± 1; p = 0.006) or no increase (0.5 ± 1; p = 0.0002) in TR. Patients with significant increase in TR had a greater change in PASP (25 mmHg; p = 0.002) after device implantation compared to those with a slight (10 mmHg; p = 0.002) or no increase (0.7 mmHg; p = 0.17). Increased TR following CRMD implantation is relatively common (33%) and correlated with subsequent risk of hospitalization for heart failure. A preventive strategy and close monitoring for development or worsening of CHF after CRMD implantation may help prevent hospital admissions.

Reuse of infected cardiac rhythm management devices in the same individual

Infected device explantation is increasingly necessary given the rapid growth in cardiac rhythm management device (CRMD) implantation in China. However, some patients with CRMD infection are unlikely to be capable of paying for a new device. Reassuringly, evidence suggests that reuse of cardiac devices can be safe and feasible. In this study, we evaluated whether explanted cardiac devices, due to infection, can be reimplanted safely within the same individuals. All patients with CRMD infection between 2007 and 2010 were entered into a computer database. From these, patients that had need for CRMD implantation and reimplantation of their infected device were analyzed for safety and complications. Sixty patients had CRMD implantation after the infected device removal, and 44 (73.3 %) patients underwent procedures for reimplantation of their infected device. The mean age of the patients was 64.8 ± 16.5 years, and 32 (72.7 %) were male. Indications for device explantation were: pocket infection (86.6 %) and endocarditis (11.4 %). The average follow-up was 20.4 ± 9.0 months. Endocarditis recurred in one (2.3 %) patient with Brugada syndrome at 17 months after reimplantation of a refurbished implantable cardioverter-defibrillator. There were three deaths during the follow-up period secondary to myocardial infarction and cerebral vascular accident. No early battery depletion or device malfunction was identified during follow-up. Our data emphasize that reimplantation of explanted CRMDs, due to infection, within the same individual is feasible, safe, and effective. Reuse of explanted CRMDs is an alternative choice for people in developing countries.

Preventing Shoulder Pain after Cardiac Rhythm Management Device Implantation: A Randomized, Controlled Study

Shoulder pain and disability ipsilateral to the implant site is a common complication of cardiac rhythm device implantation, yet very little has been published about this morbidity. We designed a study to assess the potential benefit of a simple exercise protocol in preventing shoulder pain postoperatively. Patients undergoing subcutaneous device implantation were randomized to one of two groups. The control group received standard instructions, whereas the exercise group was instructed on specific exercises aimed at strengthening or stretching the shoulder girdle, to be completed 3 days per week. Groups were postoperatively monitored for the development of shoulder discomfort and shoulder impingement by using physical examination and disability questionnaires. At 1 month, seven of 21 control patients reported developing shoulder pain or discomfort compared to one of 23 in the exercise group (P = 0.02). At 6 months, four of 23 control patients still reported worsening shoulder symptoms, compared to none in the exercise group (P = 0.11). In the control group, five of 19 patients developed a positive impingement test at 1 month, versus none in the exercise group (P = 0.01). Scores for the questionnaires designed to assess shoulder pain and dysfunction were worse in the control group. There were no activity-related complications in either group. Shoulder pain and disability occurs often following cardiac rhythm management device implantation. A simple exercise program aimed at strengthening the shoulder girdle is effective at preventing this complication.

Increased Complication Rates of Cardiac Rhythm Management Devices in ESRD Patients

Patients with end-stage renal disease (ESRD) have a high incidence of sudden cardiac death and may benefit from implantable cardioverter defibrillators (ICDs). However, ESRD also may predispose patients to device-related complications, potentially offsetting some of the benefits of prophylactic ICD placement. The purpose of this study is to compare the incidence of complications after cardiac rhythm management device (CRMD) implantation in patients with and without ESRD. An observational study was performed on 41 patients with ESRD and 123 controls without ESRD who had a CRMD (permanent pacemaker or ICD) implanted at a single institution from 1998 to 2005. Controls were matched for age, sex, type of device, and calendar year of device implantation. Primary and secondary end points were any complication and complications requiring intervention, respectively. 23 complications occurred in 16 of 41 patients with ESRD (39%) versus 13 complications in 13 of 123 matched controls (11%; P < 0.001). Major complications occurred in 29% of patients with ESRD versus 5% of controls (P < 0.001), whereas minor complications occurred in 17% and 6%, respectively (P < 0.03). Hematoma, thrombosis, and device-related complications, including elevated defibrillation thresholds, were more common in patients with ESRD (P < 0.05 for all), and there also was a nonsignificant trend toward greater infection risk (P = 0.1). There were no fatal complications in either group. Patients with ESRD had greater complication rates after CRMD implantation compared with matched controls, but these complications did not result in death. These results should be considered when evaluating patients with ESRD for prophylactic CRMD implantation, but do not support withholding such therapy.

Practice Advisory for the Perioperative Management of Patients with Cardiac Rhythm Management Devices: Pacemakers and Implantable Cardioverter–Defibrillators

Practice Advisory for the Perioperative Management of Patients with Cardiac Rhythm Management Devices: Pacemakers and Implantable Cardioverter–Defibrillators

Complications of cardiac rhythm management devices in patients with end-stage renal disease

Background: Patients (pts) with end-stage renal disease (ESRD) have a high incidence of sudden cardiac death and may benefit from prophylactic implantable defibrillator (ICD) implantation. ESRD may also predispose to device-related complications thus offsetting some of the benefits of ICD implantation. The purpose of this study is to evaluate the incidence of complications following cardiac rhythm management device implantation (CRMD) in ESRD pts.