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2.
Heart Rhythm ; 20(5): 737-743, 2023 05.
Article in English | MEDLINE | ID: mdl-36693614

ABSTRACT

BACKGROUND: The TYRX (Medtronic) absorbable antibacterial envelope has been shown to stabilize implantable cardiac devices and reduce infection. A third-generation envelope was developed to reduce surface roughness with a redesigned multifilament mesh and enhanced form factor but identical polymer coating and antibiotic concentrations as the currently available second-generation envelope. OBJECTIVE: The purpose of this study was to compare drug elution, bacterial challenge efficacy, stabilization, and absorption of second- vs third-generation envelopes. METHODS: Antibiotic elution was assessed in vitro and in vivo. For efficacy against gram-positive/gram-negative bacteria, 40 rabbits underwent device insertions with or without third-generation envelopes. For stabilization (migration, rotation), 5 sheep were implanted with 6 devices each in second- or third-generation envelopes. Prespecified acceptance criteria were <83-mm migration and <90° rotation. Absorption was assessed via gross pathology. RESULTS: Elution curves were equivalent (similarity factors ≥50 per Food and Drug Administration guidance). Third-generation envelopes eluted antibiotics above minimal inhibitory concentration (MIC) in vivo at 2 hours postimplant through 7 days, consistent with second-generation envelopes. Bacterial challenge showed reductions (P <.05) in infection with second- and third-generation envelopes. Device migration was 5.5 ± 3.5 mm (third-generation) vs 9. 9 ±7.9 mm (second-generation) (P <.05). Device rotation was 18.9° ± 11.4° (third-generation) vs 17.6° ± 15.1° (second-generation) and did not differ (P = .79). Gross pathology confirmed the absence of luminal mesh remainders and no differences in peridevice fibrosis at 9 or 12 weeks. CONCLUSION: The third-generation TYRX absorbable antibacterial envelope demonstrated equivalent preclinical performance to the second-generation envelope. Antibiotic elution curves were similar, elution was above MIC for 7 days, infections were reduced compared to no envelope, and acceptance criteria for migration, rotation, and absorption were met.


Subject(s)
Defibrillators, Implantable , Rabbits , Animals , Sheep , Anti-Bacterial Agents/pharmacology
4.
J Innov Card Rhythm Manag ; 13(8): 5104-5110, 2022 Aug.
Article in English | MEDLINE | ID: mdl-36072446

ABSTRACT

Radiographic identification of the cardiac implantable electronic device (CIED) manufacturer facilitates urgent interrogation of an unknown CIED. In the past, we relied on visualizing a manufacturer-specific X-ray logo. Recently, a free smartphone application ("Pacemaker-ID") was made available. A photograph of a chest X-ray was subjected to an artificial intelligence (AI) algorithm that uses manufacturer characteristics (canister shape, battery design) for identification. We sought to externally validate the accuracy of this smartphone application as a point-of-care (POC) diagnostic tool, compare on-axis to off-axis photo accuracy, and compare it to X-ray logo visualization for manufacturer identification. We reviewed operative reports and chest X-rays in 156 pacemaker and 144 defibrillator patients to visualize X-ray logos and to test the application with 3 standard (on-axis) and 4 non-standard (off-axis) photos (20° cranial; caudal, leftward, and rightward). Contingency tables were created and chi-squared analyses (P < .05) were completed for manufacturer and CIED type. The accuracy of the application was 91.7% and 86.3% with single and serial application(s), respectively; 80.7% with off-axis photos; and helpful for all manufacturers (range, 85.4%-96.6%). Overall, the application proved superior to the X-ray logo, visualized in 56% overall (P < .0001) but varied significantly by manufacturer (range, 7.7%-94.8%; P < .00001). The accuracy of the Pacemaker-ID application is consistent with reports from its creators and superior to X-ray logo visualization. The accuracy of the application as a POC tool can be enhanced and maintained with further AI training using recent CIED models. Some manufacturers can enhance their X-ray logos by improving placement and design.

6.
Heart Rhythm ; 18(12): 2072-2079, 2021 12.
Article in English | MEDLINE | ID: mdl-34214647

ABSTRACT

BACKGROUND: To date, only a few comparisons between subcutaneous implantable cardioverter-defibrillator (S-ICD) patients undergoing and those not undergoing defibrillation testing (DT) at implantation (DT+ vs DT-) have been reported. OBJECTIVE: The purpose of this study was to compare long-term clinical outcomes of 2 propensity-matched cohorts of DT+ and DT- patients. METHODS: Among consecutive S-ICD patients implanted across 17 centers from January 2015 to October 2020, DT- patients were 1:1 propensity-matched for baseline characteristics with DT+ patients. The primary outcome was a composite of ineffective shocks and cardiovascular mortality. Appropriate and inappropriate shock rates were deemed secondary outcomes. RESULTS: Among 1290 patients, a total of 566 propensity-matched patients (283 DT+; 283 DT-) served as study population. Over median follow-up of 25.3 months, no significant differences in primary outcome event rates were found (10 DT+ vs 14 DT-; P = .404) as well as for ineffective shocks (5 DT- vs 3 DT+; P = .725). At multivariable Cox regression analysis, DT performance was associated with a reduction of neither the primary combined outcome nor ineffective shocks at follow-up. A high PRAETORIAN score was positively associated with both the primary outcome (hazard ratio 3.976; confidence interval 1.339-11.802; P = .013) and ineffective shocks alone at follow-up (hazard ratio 19.030; confidence interval 4.752-76.203; P = .003). CONCLUSION: In 2 cohorts of strictly propensity-matched patients, DT performance was not associated with significant differences in cardiovascular mortality and ineffective shocks. The PRAETORIAN score is capable of correctly identifying a large percentage of patients at risk for ineffective shock conversion in both cohorts.


Subject(s)
Defibrillators, Implantable , Electric Countershock/statistics & numerical data , Equipment Failure Analysis , Equipment Failure/statistics & numerical data , Tachycardia, Ventricular , Comparative Effectiveness Research , Death, Sudden, Cardiac/epidemiology , Death, Sudden, Cardiac/prevention & control , Defibrillators, Implantable/adverse effects , Defibrillators, Implantable/statistics & numerical data , Equipment Failure Analysis/methods , Equipment Failure Analysis/statistics & numerical data , Europe/epidemiology , Female , Humans , Male , Materials Testing/methods , Materials Testing/statistics & numerical data , Middle Aged , Propensity Score , Risk Assessment/methods , Tachycardia, Ventricular/mortality , Tachycardia, Ventricular/therapy
7.
Heart Rhythm ; 18(12): 2050-2058, 2021 12.
Article in English | MEDLINE | ID: mdl-34271173

ABSTRACT

BACKGROUND: Recently, the Food and Drug Administration issued a recall for the subcutaneous implantable cardioverter-defibrillator (S-ICD) because of the possibility of lead ruptures and accelerated battery depletion. OBJECTIVE: The aim of this study was to evaluate device-related complications over time in a large real-world multicenter S-ICD cohort. METHODS: Patients implanted with an S-ICD from January 2015 to June 2020 were enrolled from a 19-institution European registry (Experience from the Long-term Italian S-ICD registry [ELISIR]; ClinicalTrials.gov identifier NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue. RESULTS: A total of 1254 patients (median age 52.0 [interquartile range 41.0-62.2] years; 973 (77.6%) men; 387 (30.9%) ischemic) was enrolled. Over a follow-up of 23.2 (12.8-37.8) months, complications were observed in 117 patients (9.3%) for a total of 127 device-related complications (23.6% managed conservatively and 76.4% required reintervention). Twenty-seven patients (2.2%) had unanticipated generator replacement after 3.6 (3.3-3.9) years, while 4 (0.3%) had lead rupture. Body mass index (hazard ratio [HR] 1.063 [95% confidence interval 1.028-1.100]; P < .001), chronic kidney disease (HR 1.960 [1.191-3.225]; P = .008), and oral anticoagulation (HR 1.437 [1.010-2.045]; P = .043) were associated with an increase in overall complications, whereas older age (HR 0.980 [0.967-0.994]; P = .007) and procedure performed in high-volume centers (HR 0.463 [0.300-0.715]; P = .001) were protective factors. CONCLUSION: The overall complication rate over 23.2 months of follow-up in a multicenter S-ICD cohort was 9.3%. Early unanticipated device battery depletions occurred in 2.2% of patients, while lead fracture was observed in 0.3%, which is in line with the expected rates reported by Boston Scientific.


Subject(s)
Death, Sudden, Cardiac/epidemiology , Defibrillators, Implantable/adverse effects , Registries , Adult , Death, Sudden, Cardiac/etiology , Device Removal , Equipment Failure , Female , Follow-Up Studies , Humans , Incidence , Italy/epidemiology , Male , Middle Aged , Time Factors
8.
Card Electrophysiol Clin ; 13(3): 459-471, 2021 09.
Article in English | MEDLINE | ID: mdl-34330373

ABSTRACT

Guidelines exist for monitoring to diagnose and manage patients with several different conditions. Although there have been recent updates to the guidelines, the constantly evolving and advancing nature of the technologies creates a gap at times between the newest monitors, the indications for their use, and the reimbursement by the payers. The key element to the choice of the modality of monitoring remains matching the correct technology to the type, severity, frequency, and duration of the patient's symptoms.


Subject(s)
Electrocardiography, Ambulatory , Humans
9.
Europace ; 23(7): 983-1008, 2021 07 18.
Article in English | MEDLINE | ID: mdl-33878762

ABSTRACT

With the global increase in device implantations, there is a growing need to train physicians to implant pacemakers and implantable cardioverter-defibrillators. Although there are international recommendations for device indications and programming, there is no consensus to date regarding implantation technique. This document is founded on a systematic literature search and review, and on consensus from an international task force. It aims to fill the gap by setting standards for device implantation.


Subject(s)
Defibrillators, Implantable , Pacemaker, Artificial , Asia , Consensus , Humans , United States
10.
Europace ; 23(9): 1446-1455, 2021 09 08.
Article in English | MEDLINE | ID: mdl-33755136

ABSTRACT

AIM: The Prevention of Arrhythmia Device Infection Trial (PADIT) infection risk score, developed based on a large prospectively collected data set, identified five independent predictors of cardiac implantable electronic device (CIED) infection. We performed an independent validation of the risk score in a data set extracted from U.S. healthcare claims. METHODS AND RESULTS: Retrospective identification of index CIED procedures among patients aged ≥18 years with at least one record of a CIED procedure between January 2011 and September 2014 in a U.S health claims database. PADIT risk factors and major CIED infections (with system removal, invasive procedure without system removal, or infection-attributable death) were identified through diagnosis and procedure codes. The data set was randomized by PADIT score into Data Set A (60%) and Data Set B (40%). A frailty model allowing multiple procedures per patient was fit using Data Set A, with PADIT score as the only predictor, excluding patients with prior CIED infection. A data set of 54 042 index procedures among 51 623 patients with 574 infections was extracted. Among patients with no history of prior CIED infection, a 1 unit increase in the PADIT score was associated with a relative 28% increase in infection risk. Prior CIED infection was associated with significant incremental predictive value (HR 5.66, P < 0.0001) after adjusting for PADIT score. A Harrell's C-statistic for the PADIT score and history of prior CIED infection was 0.76. CONCLUSION: The PADIT risk score predicts increased CIED infection risk, identifying higher risk patients that could potentially benefit from targeted interventions to reduce the risk of CIED infection. Prior CIED infection confers incremental predictive value to the PADIT score.


Subject(s)
Defibrillators, Implantable , Pacemaker, Artificial , Prosthesis-Related Infections , Adolescent , Adult , Arrhythmias, Cardiac/therapy , Defibrillators, Implantable/adverse effects , Delivery of Health Care , Electronics , Humans , Pacemaker, Artificial/adverse effects , Prosthesis-Related Infections/diagnosis , Prosthesis-Related Infections/epidemiology , Prosthesis-Related Infections/prevention & control , Retrospective Studies , Risk Factors
11.
JACC Clin Electrophysiol ; 7(8): 976-987, 2021 08.
Article in English | MEDLINE | ID: mdl-33640345

ABSTRACT

OBJECTIVES: The goal of this study was to test whether continuous automatic remote patient monitoring (RPM) linked to centralized analytics reduces nonactionable in-person patient evaluation (IPE) but maintains detection of at-risk patients and provides actionable notifications. BACKGROUND: Conventional ambulatory care requires frequent IPEs. Many encounters are nonactionable, and additional unscheduled IPEs occur. METHODS: Patients receiving implantable cardioverter-defibrillators for Class I/IIa indications were randomized (2:1) to RPM or conventional follow-up, and they were followed up for 15 months. IPEs were conducted every 3 months in the conventional care group but at 3 and 15 months with RPM. Groups were compared for patient retention, nonactionable IPEs, and discovery of at-risk patients during 1 year of exclusive RPM. Frequency and value of RPM alerts were assessed. RESULTS: Patients enrolled (mean age 63.5 ± 12.8 years; male 71.9%; left ventricular ejection fraction 29.0 ± 10.7%; primary prevention 72.3%; n = 1450) were similar between groups (977 RPM vs. 473 conventional care). Mean follow-up durations were 407 ± 103 days for the RPM group versus 399 ± 111 days for the conventional care group (p = 0.165). Patient attrition to follow-up was 42% greater with conventional care (20.1% [87 of 431]) versus RPM (14.2% [129 of 908]; p = 0.007). Nonactionable IPEs were reduced 81% by RPM (0.7 per patient year) compared with conventional care (3.6 per patient year; p < 0.001) but event discoveries remained similar (2.9 per patient year). In RPM, alert rate was median 1 per patient (interquartile range: 0 to 3) with >50% actionability, indicating low volume but high clinical value. Unscheduled IPE was the basis for discovery of 100% of intercurrent problems in RPM and also 75% in conventional care, indicating limited value of appointment-based follow-up for problem discovery. The number of IPEs needed to discover an actionable event was 8.2 in Conventional, 4.9 in RPM, and 2.1 when alert driven (p < 0.001). CONCLUSIONS: RPM transformed ambulatory care to IPE directed to those patients with clinically actionable events when required. Filtering patient information by digitally driven remote monitoring expends fewer clinic resources while providing a greater yield of actionable interventions. (Lumos-T Safely Reduces Routine Office Device Follow-up [TRUST]; NCT00336284).


Subject(s)
Ambulatory Care , Ventricular Function, Left , Aged , Humans , Male , Middle Aged , Monitoring, Physiologic , Primary Prevention , Stroke Volume
13.
Circ Arrhythm Electrophysiol ; 13(11): e008680, 2020 11.
Article in English | MEDLINE | ID: mdl-33028082

ABSTRACT

BACKGROUND: Left ventricular (LV) epicardial pacing results in slowly propagating paced wavefronts. We postulated that this effect might limit cardiac resynchronization therapy efficacy in patients with LV enlargement using conventional biventricular pacing with single-site LV pacing, but be mitigated by LV stimulation from 2 widely spaced sites using MultiPoint pacing with wide anatomic separation (MPP-AS: ≥30 mm). We tested this hypothesis in the multicenter randomized MPP investigational device exemption trial. METHODS: Following implant, quadripolar biventricular single-site pacing was activated in all patients (n=506). From 3 to 9 months postimplant, among patients with available baseline LV end-diastolic volume (LVEDV) measures, 188 received biventricular single-site pacing and 43 received MPP-AS. Patients were dichotomized by median baseline LVEDV indexed to height (LVEDVIMedian). Outcomes were measured by the clinical composite score (primary efficacy end point), quality of life, LV structural remodeling (↑EF >5% and ↓ESV 10%) and heart failure event/cardiovascular death. RESULTS: LVEDVIMedian was 1.1 mL/cm. Baseline characteristics differed in patients with LVEDVI>Median versus LVEDVI≤Median. Among patients with LVEDVI>Median, biventricular single-site pacing was less efficacious compared to patients with LVEDVI≤Median (clinical composite score, 65% versus 79%). In contrast, MPP-AS programming generated greater clinical composite score response (92% versus 65%, P=0.023) and improved quality of life (-31.0±29.7 versus -15.7±22.1, P=0.038) versus biventricular single-site pacing in patients with LVEDVI>Median. Reverse remodeling trended better with MPP-AS programming. In patients with LVEDVI>Median, heart failure event rate increased following the 3-month randomization point with biventricular single-site pacing (0.0150±0.1725 in LVEDVI>Median versus -0.0190±0.0808 in LVEDVI ≤Median, P=0.012), but no heart failure event occurred in patients with MPP-AS programming between 3 and 9 months in LVEDVI>Median. All measured outcomes did not differ in patients receiving MPP-AS and biventricular single-site pacing with LVEDVI≤Median. CONCLUSIONS: Conventional biventricular single-site pacing, even with a quadripolar lead, has reduced efficacy in patients with LV enlargement. However, the greatest response rate in patients with larger hearts was observed when programmed to MPP-AS pacing.


Subject(s)
Cardiac Resynchronization Therapy , Heart Failure/therapy , Heart Rate , Hypertrophy, Left Ventricular/physiopathology , Ventricular Function, Left , Ventricular Remodeling , Aged , Cardiac Resynchronization Therapy/adverse effects , Cardiac Resynchronization Therapy/mortality , Female , Heart Failure/diagnosis , Heart Failure/mortality , Heart Failure/physiopathology , Humans , Hypertrophy, Left Ventricular/diagnostic imaging , Hypertrophy, Left Ventricular/mortality , Male , Middle Aged , Quality of Life , Randomized Controlled Trials as Topic , Recovery of Function , Retrospective Studies , Time Factors , Treatment Outcome , United States
14.
Heart Rhythm O2 ; 1(3): 222-226, 2020 Aug.
Article in English | MEDLINE | ID: mdl-32835317

ABSTRACT

Our world is faced with a global pandemic that threatens to overwhelm many national health care systems for a prolonged period. Consequently, the elective long-term cardiac implantable electronic device (CIED) management of millions of patients is potentially compromised, raising the likelihood of patients experiencing major adverse events owing to loss of CIED therapy. This review gives practical guidance to health care providers to help promptly recognize the requirement for expert consultation for urgent interrogation and/or surgery in CIED patients.

15.
J Cardiovasc Electrophysiol ; 31(9): 2533-2538, 2020 09.
Article in English | MEDLINE | ID: mdl-32716084

ABSTRACT

We present a case report of severed epicardial atrial lead salvage using an IS-1 lead extender. A 37-year-old male with single ventricle physiology, Fontan palliation, sinus node dysfunction, recurrent atrial tachycardias, and atrial fibrillation resulting in failing Fontan physiology presented with failure of the atrial pacing lead. The patient was initially paced with an epicardial system that had to be removed due to pocket infection, and the epicardial leads were cut and abandoned. Given his significant sinus node dysfunction he required atrial pacing to allow for rhythm control. The failing Fontan physiology of the patient precluded him from undergoing surgery for epicardial lead placement or a complex intravascular lead placement procedure (although anatomically feasible). We considered the option of salvaging the existing epicardial atrial leads to provide atrial pacing, allowing for rhythm control and improvement of his failing Fontan physiology as a bridge to a more permanent pacing solution. This case report is important because it demonstrates how a lead extender can be used to salvage a severed pacemaker lead. This may be useful for patients in whom implantation of new leads is not promptly feasible due to patient anatomy and/or clinical status.


Subject(s)
Fontan Procedure , Pacemaker, Artificial , Adult , Cardiac Pacing, Artificial , Fontan Procedure/adverse effects , Humans , Male , Pericardium/surgery , Sick Sinus Syndrome/therapy
16.
J Cardiovasc Electrophysiol ; 31(9): 2415-2424, 2020 09.
Article in English | MEDLINE | ID: mdl-32618399

ABSTRACT

INTRODUCTION: To improve the mechanistic understanding of spontaneous initiation of ventricular fibrillation (VF), we characterized the patterns of premature ventricular complex (PVC) preceding spontaneous VF in primary and secondary implantable cardioverter-defibrillator (ICD) recipients. METHODS AND RESULTS: A single-center, cross-sectional analysis of 1209 patients with primary and secondary prevention ICD identified 190 patients who received ICD therapy (firing or antitachycardia pacing) for VF or monomorphic ventricular tachycardia (MMVT). Initiation was quantified by the coupling interval (CI), the cycle length immediately preceding the CI (CL(-1)), the CI corrected by CL(-1) using Fridericia's formula (CIc), and the prematurity index (PI). In both VF (n = 44; 23%) and MMVT (n = 134; 71%), the most common pattern of initiation was late-coupled PVC, followed by the short-long-short pattern. The parameters such as pre-initiation median CL, CL(-1), CI, and PI were not significantly different between VF and MMVT for any patterns. At least some events (45% of VF and 63% of MMVT) had extremely long CIs beyond the QTc cut-off estimated from the CL(-1), suggestive of initiation by a train of multiple PVCs or nonsustained VT instead of a single PVC. CONCLUSION: Some spontaneous VF events in ICD recipients appear to be initiated by a train of multiple PVC or nonsustained VT rather than a single PVC. This finding indicates that patterns of a single PVC are not an important determinant of VF initiation and thus account for conflicting results in previous studies.


Subject(s)
Defibrillators, Implantable , Ventricular Fibrillation , Cross-Sectional Studies , Humans , Tachycardia, Ventricular/diagnosis , Tachycardia, Ventricular/therapy , Ventricular Fibrillation/diagnosis , Ventricular Fibrillation/therapy , Ventricular Premature Complexes/diagnosis
17.
Transfusion ; 60(8): 1741-1746, 2020 08.
Article in English | MEDLINE | ID: mdl-32579271

ABSTRACT

BACKGROUND: Transvenous lead extractions (TLEs) have increased in number due to an increased prevalence of cardiac implantable devices. Bleeding complications associated with TLEs can be catastrophic, and many institutions order blood components to be available in the procedure room. There are few studies supporting or refuting this practice. We evaluated transfusion rates for TLEs at a single, high-volume center to assess the need for having blood in the procedure room. STUDY DESIGN AND METHODS: Patients undergoing TLEs from April 2010 to February 2019 were identified from our institutional database. The percentage of patients transfused intraoperatively, the number of units transfused, and the reasons for transfusion were determined from the database and by manual chart review. RESULTS: A total of 473 patients underwent a TLE during this time frame. Of these, only 17 patients (3.6%) received a red blood cell (RBC) transfusion. Ten of the 17 patients received RBCs secondary to preoperative anemia. Of the remaining seven patients, only four patients received more than 2 RBC units, and only one received more than 10 RBC units. No patient received more than 2 RBC units or any plasma or platelets in the past 4 years. CONCLUSION: Due to improvements in procedural techniques, advent of accessible remote blood allocation systems, and changes in transfusion practice (e.g., electronic crossmatch), routinely having blood components in the procedure room for every TLE may be an outdated practice for high-volume centers.


Subject(s)
Anemia , Continuous Renal Replacement Therapy , Databases, Factual , Defibrillators, Implantable , Erythrocyte Transfusion , Lead/blood , Preoperative Care , Adult , Aged , Aged, 80 and over , Anemia/blood , Anemia/therapy , Female , Humans , Male , Middle Aged
18.
Pacing Clin Electrophysiol ; 43(1): 2-9, 2020 01.
Article in English | MEDLINE | ID: mdl-31691986

ABSTRACT

BACKGROUND: Pacemaker battery depletion triggers alert for replacement notification and results in automatic reprogramming, which has been shown to be associated with relevant cardiorespiratory symptoms and adverse clinical events. OBJECTIVE: Determine if electrocardiogram (ECG) pacing features may be predictive of pacemaker battery depletion and clinical risk. METHODS: This is an ECG substudy of a cohort analysis of 298 subjects referred for pacemaker generator replacement from 2006 to 2017. Electronic medical record review was performed; clinical, ECG, and pacemaker characteristics were abstracted. We applied two ECG prediction rules for pacemaker battery depletion that are relevant to all major pacemaker manufacturers except Boston Scientific and MicroPort: (1) atrial pacing not at a multiple of 10 and (2) nonsynchronous ventricular pacing not at a multiple of 10, to determine diagnostic sensitivity, specificity, and risk in applicable ECG subjects. RESULTS: We excluded 32 subjects not at replacement notification or duplicate surgeries. Overall, 176 of 266 subjects (66.2%) demonstrated atrial pacing or nonsynchronous ventricular pacing on preoperative ECG. When utilizing both rules, 139 of 176 preoperative ECGs and 12 of 163 postoperative ECGs met criteria for battery depletion yielding reasonable sensitivity (79.0%), high specificity (92.6%), and a positive likelihood ratio of 11.6:1. These rules were associated with significant increase in cardiorespiratory symptoms (P < .001) and adverse clinical events (P < .025). CONCLUSIONS: The "Rules of Ten" provided reasonable sensitivity and specificity for detecting replacement notification in pacemaker subjects with an applicable ECG. This ECG tool may help clinicians identify most patients with pacemaker battery depletion at significant clinical risk.


Subject(s)
Electric Power Supplies , Electrocardiography/methods , Equipment Failure , Pacemaker, Artificial , Aged , Aged, 80 and over , Female , Humans , Male , Predictive Value of Tests , Retrospective Studies , Sensitivity and Specificity
20.
J Cardiovasc Electrophysiol ; 30(11): 2453-2459, 2019 11.
Article in English | MEDLINE | ID: mdl-31502324

ABSTRACT

BACKGROUND: An internal risk stratification algorithm was developed to decrease the risk of major adverse cardiac events (MACEs) during lead extractions (LEs). OBJECTIVE: To report upon the impact of a risk stratification algorithm (RISE [RIsk Stratification prior to lead Extraction] protocol) on outcomes of LEs in a high-volume center. METHODS: A retrospective review of a prospectively maintained LEs database was performed to identify features associated with MACEs. On the basis of the retrospective data, the RISE protocol differentiated LEs procedures into "High" and "Low" risk for occurrence of MACEs. High-risk LEs included dual-coil defibrillator lead (≥3 years), pacemaker and single-coil lead (≥5 years), and any StarFix coronary sinus lead. During the prospective evaluation of the RISE protocol, "High-risk" LEs were performed in an operating room (OR) or hybrid laboratory with the cardiac anesthesiologist, OR nursing team, perfusionist in the room, and a cardiac surgeon on the premises. "Low-risk" LEs were performed in the electrophysiology (EP) laboratory with anesthesia provided by EP nursing team. The preintervention (pre-RISE) and postintervention (post-RISE) group spanned 19 and 40 months and consisted of 449 (632 leads) and 751 patients (1055 leads), respectively. The primary outcome of MACEs in the two groups was compared. RESULTS: Protocol compliance was 100%. The primary outcome of MACEs occurred in 15 patients (3.34%) before and 12 (1.6%) after implementation of the RISE protocol (P = .04). CONCLUSION: RISE identified a low-risk group where minimal resources are needed and allowed for rapid intervention in the high-risk group that reduced the consequences of MACEs.


Subject(s)
Clinical Protocols , Defibrillators, Implantable , Device Removal/adverse effects , Pacemaker, Artificial , Postoperative Complications/prevention & control , Aged , Aged, 80 and over , Databases, Factual , Device Removal/mortality , Female , Hospitals, High-Volume , Humans , Male , Middle Aged , Ohio , Postoperative Complications/mortality , Prospective Studies , Prosthesis Design , Quality Improvement , Quality Indicators, Health Care , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
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