| 1. |
|
|
| 2. |
- Kennergren, Charles, 1948, et al.
(författare)
-
Laser-assisted lead extraction: the European experience.
- 2007
-
Ingår i: Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. - : Oxford University Press (OUP). - 1099-5129. ; 9:8, s. 651-6
-
Tidskriftsartikel (refereegranskat)abstract
- AIMS: The aim of this study is to investigate the safety and effectiveness of Excimer laser-assisted lead extraction in Europe. The final European multi-centre study experience is presented. METHOD AND RESULTS: The Excimer is a cool cutting laser (50 degrees C) with a wavelength of 308 nm. The energy is emitted from the tip of a flexible sheath and is absorbed by proteins and lipids, 64% of the energy is absorbed at a tissue depth of 0.06 mm. The sheath is positioned over the lead, and the fibrosis surrounding the lead is vaporized while advancing the sheath without damaging other leads. From August 1996 to March 2001, 383 leads (170 atrial, 213 ventricular) in 292 patients (mean age 61.6 years, range 13-96) were extracted at 14 European centres. Mean implantation time was 74 months (3-358). Most frequent indications were pocket infection (26%), non-functional leads (21%), patient morbidity (21%), septicaemia or endocarditis (14%), erosion (5%), and lead interference (8%). Median extraction time was 15 min (1-300). Complete extraction was achieved in 90.9% of the leads and partial extraction in 3.4%. Extraction failed in 5.7% of the leads. Major complications = perforations caused 10/22 (3.4/5.7%) of the failures. Most partially extracted patients were considered clinically successful, as only minor lead parts without clinical significance were left. Femoral non-laser technique was used to remove 8/12 of the non-complication failures. The total complication rate, including five minor complications (1.7%), was 5.1%. No in-hospital mortality occurred. CONCLUSION: Pacing and implantable cardioverter-defibrillator leads can safely, effectively, and predictably be extracted. Open-heart extractions can be limited to special cases. The results indicate that the traditional policy of abandoning redundant leads, instead of removing them, may be obsolete in many patients.
|
|
| 3. |
- Arora, Y., et al.
(författare)
-
Location of Superior Vena Cava Tears in Transvenous Lead Extraction
- 2022
-
Ingår i: Annals of Thoracic Surgery. - : Elsevier BV. - 0003-4975. ; 113:4, s. 1165-1171
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND Superior vena cava (SVC) tears are rare but potentially lethal complications associated with transvenous lead extraction. When lacerations occur, surgeons need to be prepared for an emergent response. Nonetheless, little is known about the precise whereabouts of these lesions. Understanding the location and injury patterns enables a more anticipated and targeted surgical response.& nbsp;METHODS We collected data via physician interviews after an SVC laceration occurred. These physicians were identified through the US Food and Drug Administration's Manufacturer and User Facility Device Experience database and independent physician reports of adverse events. We identified 116 reports of SVC tears between July 1, 2016, and July 31, 2018. For an SVC tear to be included in our registry, a cardiothoracic surgeon had to be physically present to confirm the injury via emergent sternotomy. In each case, the surgeon recorded the SVC injury's exact location after a repair was attempted.& nbsp;RESULTS During the study period, 116 SVC tears were confirmed by sternotomy. Tears occurred in any combination of the following locations: SVC-innominate vein, body of the SVC, and SVC-right atrial junction. The majority of tears (n = 72; 62%) were located in the isolated body of the SVC, followed by the SVC-right atrial junction (n = 23;19.8%) and the SVC-innominate junction (n = 17;14.6%). Combined tears were rare, accounting for only 3.6% (n = 4) of the adverse events recorded.& nbsp;CONCLUSIONS Most SVC tears occurred in the isolated body of the SVC. The second most common location was the SVC-right atrial junction. The SVC-innominate junction was the third most common location for these injuries. Combined tears were uncommon. & nbsp;(C)& nbsp;2022 by The Society of Thoracic Surgeons
|
|
| 4. |
- Boehmer, John P, et al.
(författare)
-
Adjudication of mortality events in a heart failure-arrhythmia trial by a multiparameter descriptive method: comparison with methods used in heart failure trials and methods used in arrhythmia trials.
- 2008
-
Ingår i: Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing. - : Springer Science and Business Media LLC. - 1383-875X. ; 23:2, s. 101-10
-
Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: Mortality events in studies of cardiovascular disease are currently adjudicated using different methodologies depending on the investigators' preferences. Traditionally, deaths have been categorized by a single term, such as sudden, ischemic, or pump failure, a method that can be referred to as "categorical". In contrast, deaths may be categorized using several specific pieces of information about the event, a method that can be referred to as "multiparameter descriptive." Herein, we describe an adaptation of this descriptive method in a trial of patients with heart failure and arrhythmias. METHODS AND RESULTS: Case examples were selected from two clinical trials of an investigational implantable cardioverter-defibrillator (ICD)-biventricular pacing system in patients with symptomatic heart failure and a class I indication for ICD implantation, and the complete results for one of the trials are given. Deaths were classified according to the new descriptive method, and also according to published categorical methods for heart failure and arrhythmia trials. The descriptive method preserved traditional arrhythmia and heart failure trial single category classifications of death. Furthermore, there was agreement between the arrhythmia and heart failure category classifications in 126 of the 148 of the mortality events adjudicated (85%). CONCLUSION: A descriptive method for the classification of death retains more data and allows for comparison among trials using different classification schemes. This may allow greater mechanistic insight into study populations that have diverse and frequently multiple etiologies of death.
|
|
| 5. |
- Bratel, John, 1953, et al.
(författare)
-
Treatment of oral infections prior to heart valve surgery does not improve long-term survival
- 2011
-
Ingår i: Swedish Dental Journal. - 0039-6745. ; 35:2, s. 49-55
-
Tidskriftsartikel (refereegranskat)abstract
- The objective was to evaluate the importance of preoperative elimination of oral infections and oral health for survival after heart valve surgery In a group of patients (n=149; treatment group, GP group), oral health was examined and dental treatment was performed 3-6 months prior to heart valve surgery. In a second group (n=103; control group, SP group), oral health was examined postoperatively, but patients did not receive dental treatment prior to surgery. Sixteen years after heart valve surgery was performed, morbidity endpoint data were obtained. Differences in survival between the two groups and the influence of differences in oral health were analyzed. Fewer patients survived in the study group (37%) compared with the control group (45%). Mean survival was 122.9 months in the GP group compared with 143.3 months in the SP group, including time to death and those alive at the endpoint (p=0.018). A positive relationship was found between the number of teeth and survival, with RR = 0.98 (95% CI 0962-0.996 (p=0.016)).The deaths from heart valve disease were 18% in the GP group and 7% in the SP group (chi2=3.65, df=1, p=0.56). At the long-term follow-up,the results of the present study show,that it was not possible to demonstrate that dental treatment before heart valve surgery improved survival. Therefore, the need for extensive dental treatment prior to heart valve surgery may be reconsidered.
|
|
| 6. |
- Gottfridsson, Christer, 1958, et al.
(författare)
-
Acute evaluation of transthoracic impedance vectors using ICD leads.
- 2009
-
Ingår i: Pacing and clinical electrophysiology : PACE. - : Wiley. - 1540-8159 .- 0147-8389. ; 32:6, s. 762-71
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Minute ventilation (MV) has been proven to be very useful in rate responsive pacing. The aim of this study was to evaluate the feasibility of using implantable cardioverter-defibrillator (ICD) leads as part of the MV detection system. METHODS: At implant in 10 patients, the transthoracic impedance was measured from tripolar ICD, tetrapolar ICD, and atrial lead vectors during normal, deep, and shallow voluntary respiration. MV and respiration rate (RespR) were simultaneously measured through a facemask with a pneumotachometer (Korr), and the correlations with impedance-based measurements were calculated. Air sensitivity was the change in impedance per change in respiratory tidal volume, ohms (Omega)/liter (L), and the signal-to-noise ratio (SNR) was the ratio of the respiratory and cardiac contraction components. RESULTS: The air sensitivity and SNR in tripolar ICD vector were 2.70 +/- 2.73 ohm/L and 2.19 +/- 1.31, respectively, and were not different from tetrapolar. The difference in RespR between tripolar ICD and Korr was 0.2 +/- 1.91 breaths/minute. The regressed correlation coefficient between impedance MV and Korr MV was 0.86 +/- 0.07 in tripolar ICD. CONCLUSIONS: The air sensitivity and SNR in tripolar and tetrapolar ICD lead vectors did not differ significantly and were in the range of the values in pacemaker leads currently used as MV sensors. The good correlations between impedance-based and Korr-based RespR and MV measurements imply that ICD leads may be used in MV sensor systems.
|
|
| 7. |
- Kennergren, Charles, 1948
(författare)
-
A European perspective on lead extraction: part I.
- 2008
-
Ingår i: Heart rhythm : the official journal of the Heart Rhythm Society. - : Elsevier BV. - 1547-5271. ; 5:1, s. 160-2
-
Tidskriftsartikel (refereegranskat)
|
|
| 8. |
- Kennergren, Charles, 1948, et al.
(författare)
-
A single-centre experience of over one thousand lead extractions.
- 2009
-
Ingår i: Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. - : Oxford University Press (OUP). - 1532-2092. ; 11:5, s. 612-7
-
Tidskriftsartikel (refereegranskat)abstract
- AIMS: The aim of the study was to present a single-centre experience of pacemaker and implantable cardioverter defibrillator (ICD) lead extraction using different methods, mainly laser-assisted extraction. METHODS AND RESULTS: Data from 1032 leads and 647 procedures were gathered. A step-by-step approach using different techniques while performing an ongoing risk-benefit analysis was used. The most common indications were local infection, systemic infection, non-functional lead, elective lead replacement, and J-wire fracture. Mean implantation time for all leads was 69 months and for laser-extracted leads 91 months. Laser technique was used to extract 60% of the leads, 29% were manually extracted, 6% extracted with mechanical tools, 4% were surgically removed, and 0.6% extracted by a femoral approach. Failure rate was 0.7%, and major complication rate was 0.9%. No extraction-related mortality occurred. Median time for laser extraction was 2 min. Long implantation time was not a risk factor for failure or for complication. CONCLUSION: Pacing and ICD leads can safely, successfully, and effectively be extracted. Leads can often be extracted by a superior transvenous approach; however, open-chest and femoral extractions are still required. Laser-assisted lead extraction proved to be a useful technique to extract leads that could not be removed by manual traction. The results indicate that the paradigm of abandoning redundant leads, instead of removing them, may have to be reconsidered.
|
|
| 9. |
- Kennergren, Charles, 1948
(författare)
-
Cardiac implantable electronic device treatment: taking care of complications.
- 2009
-
Ingår i: Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. - : Oxford University Press (OUP). - 1532-2092. ; 11:11, s. 1419-20
-
Tidskriftsartikel (refereegranskat)
|
|
| 10. |
- Kennergren, Charles, 1948
(författare)
-
Cellular monitoring in open heart surgery. Monitoring of markers for ischemia, free amino acids, glucose and lactate in the myocardial interstitial fluid before, during and after cardiac surgery using microdialysis technique
- 2000
-
Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Protection of the myocardium during open-heart surgery is a field of intense development. Numerous protocols have been proposed to minimize ischemia, since the beginning of open-heart surgery more than 40 years ago. Their evaluation is largely based on clinical outcome, since available methods lack the sensitivity required to determine the effects on myocardial oxygenation by small, but sometimes critical, methodological developments. We applied microdialysis to the myocardium with the aim to monitor the degree of ischemia from the concentrations of ASAT, troponin-T, free amino acids, glucose and lactate before, during and after cardioplegia. We also aimed at correlating postoperative events with the concentration of these markers. The myocardium of a mixed group of patients undergoing coronary artery by-pass grafting (CABG) and/or aortic valve surgery was monitored with a flexible microdialysis probe developed in our laboratory. The safety and function of the probe was first examined in an animal model for myocardial ischemia and then confirmed in man. Specific time courses were found in the interstitium for ASAT, troponin-T and several amino acids, during and after cardioplegia. Twenty and 300 times higher peak concentrations than in plasma were recorded in the interstitium for ASAT and troponin-T, respectively. The regulation of glucose and lactate was studied in the myocardial interstitium before, during and after cardioplegia in another group of patients undergoing CABG surgery. Concentrations of glucose and lactate were, to our knowledge, determined for the first time in the myocardial interstitium, with the use of internal calibration. Glucose was not critically reduced during cardioplegia, nor did lactate reach pathologically high concentrations. Even though transient elevations of marker levels coincided with postoperative clinical events in a number of patients, a larger population than was studied would be required for significant correlation. It is concluded that microdialysis sampling of the myocardial interstitial fluid is a safe procedure in clinical use. The approach has a potential for the evaluation of new technology for myocardial protection and for postoperative surveillance
|
|
| 11. |
- Kennergren, Charles, 1948
(författare)
-
European perspective on lead extraction: part II.
- 2008
-
Ingår i: Heart rhythm : the official journal of the Heart Rhythm Society. - : Elsevier BV. - 1547-5271. ; 5:2, s. 320-3
-
Tidskriftsartikel (refereegranskat)
|
|
| 12. |
- Lensvelt, L. M. H., et al.
(författare)
-
Mechanical extraction of cardiac implantable electronic devices leads with long dwell time: Efficacy and safety of the step up approach
- 2021
-
Ingår i: Pacing and Clinical Electrophysiology: PACE. - : Wiley. - 0147-8389 .- 1540-8159. ; 44:1, s. 120-128
-
Tidskriftsartikel (refereegranskat)abstract
- The aim of this study was to evaluate the efficacy and safety of the stepwise mechanical transvenous lead extraction approach in a patient population with chronically implanted transvenous leads with a long dwell time. From January 2014 till December 2018, all lead extractions with lead dwell time >= 5 years performed at our tertiary centre were retrospectively analysed. A total of 173 leads, from 78 patients (median age 68 years; 81% male) with a median dwell time of 9 years (interquartile range [IQR] 5) were extracted, with three or more leads in 42% of the patients. Right atrial leads: 41%; right ventricular pacing leads: 16%; implantable cardioverter-defibrillator (ICD) leads: 31% (72% dual coil); coronary sinus leads: 12%. The majority (75%) of the leads had an active fixation. Most frequent indication for extraction was pocket infection/erosion (76%). Overall clinical success was 97%, and complete procedural success was 93%. Venous patency, assessed with venous angiography, was well preserved in 93% of the cases. The overall procedural complication rate was 3.8% (2.6% major and 1.3% minor). Despite the complexity of the population and a very long dwell time (median 9 years), a clinical success rate of 97% was achieved with the stepwise mechanical approach. Analysis of impeding progression of pectoral extraction suggests that dense fibrosis and sharp lead curvature in the transvenous trajectory pose a challenge. Complication rate was low, and acute venous patency was generally well preserved.
|
|
| 13. |
- Mantovani, Vittorio, 1965, et al.
(författare)
-
Microdialysis for myocardial metabolic surveillance: developing a clinical technique.
- 2006
-
Ingår i: Clinical physiology and functional imaging. - 1475-0961. ; 26:4, s. 224-31
-
Tidskriftsartikel (refereegranskat)abstract
- Metabolic surveillance of the myocardium is of great interest in cardiac surgery. Microdialysis allows sampling of chemical substances from the interstitial fluid for immediate analysis. The two objectives of this study were to develop a technique for simple and safe implantation of a commercially available microdialysis probe (CMA-70) into the myocardium and to obtain reference data for further use and metabolic control. Eighteen pigs were used in an experimental ischaemic heart model where the left anterior descending coronary artery was occluded for 20 min. Microdialysis was performed proximally as well as distally to the arterial occlusion site corresponding to a control and an ischaemic area in the heart. Two techniques were tried for probe implantation, using either a pacemaker wire attached to the probe tip or a needle introducer. Metabolic substrates (glucose, lactate, glycerol and pyruvate) were collected before, during and after ischaemia, for up to 6 h. Both techniques were highly effective in registering metabolic changes due to ischaemia with sharp time resolution, but the needle introducer was superior regarding probe durability. It is concluded that the CMA-70 microdialysis probe implanted with the needle introducer allows for an accurate monitoring of myocardial metabolism during a prolonged period of time. Future studies in the human heart are warranted to further validate the technique.
|
|
| 14. |
- Mantovani, Vittorio, et al.
(författare)
-
Myocardial metabolism assessed by microdialysis: a prospective randomized study in on- and off-pump coronary bypass surgery.
- 2010
-
Ingår i: International journal of cardiology. - : Elsevier BV. - 1874-1754 .- 0167-5273. ; 143:3, s. 302-8
-
Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: The aim of the study was to compare energetic metabolism in the myocardium during coronary surgery with and without cardiopulmonary bypass by means of microdialysis. METHODS: Twenty-six low-risk patients were prospectively randomized to off-pump versus on-pump surgery. Microdialysis was used to sample myocardial interstitial fluid during and for 23hours after surgery. RESULTS: Preoperative characteristics and clinical outcome were similar in both groups. Blood glucose and lactate did not differ between groups throughout the observation time. During surgery, intramyocardial levels of glucose, pyruvate and urea were unaffected in off-pump patients, while the same substances significantly decreased (p<0.05) in on-pump patients during cardioplegic arrest, and increased during reperfusion. Interstitial lactate levels were higher during off-pump surgery (p<0.05). From 3 to 15hours after surgery, intramyocardial concentrations of glucose, urea and lactate were higher in off-pump patients (p<0.001), while pyruvate was higher in on-pump patients (p<0.01). Intramyocardial lactate/pyruvate ratio never differed between groups. Postoperatively, cumulative blood release of troponin-T was significantly higher in the on-pump group (p<0.005). CONCLUSIONS: Microdialysis could demonstrate significant differences in energetic metabolism between the two groups. Our data confirm and might help in explaining the lower release of myocardial ischemic markers after off-pump surgery.
|
|
| 15. |
- Mittal, S., et al.
(författare)
-
The World-wide Randomized Antibiotic Envelope Infection Prevention (WRAP-IT) trial: Long-term follow-up
- 2020
-
Ingår i: Heart Rhythm. - : Elsevier BV. - 1547-5271. ; 17:7, s. 1115-1122
-
Tidskriftsartikel (refereegranskat)abstract
- Background: The World-wide Randomized Antibiotic Envelope Infection Prevention trial reported a 40% reduction in major cardiac implantable electronic device (CIED) infections within 12 months of the procedure with the use of an antibacterial-eluting envelope (TYRX Absorbable Antibacterial Envelope, Medtronic, Mounds View, MN). Objective: The purpose of this report was to describe the longer-term (>12 months) envelope effects on infection reduction and complications. Methods: All trial patients who underwent CIED replacement, upgrade, revision, or initial cardiac resynchronization therapy – defibrillator implantation received standard-of-care infection prophylaxis and were randomized in a 1:1 ratio to receive the envelope or not. CIED infection incidence and procedure and system-related complications were characterized through all follow-up (36 months) by using Cox proportional hazards regression modeling. Results: In total, 6800 patients received their intended randomized treatment (3371 envelope; 3429 control; mean follow-up period 21.0 ± 8.3 months). Major CIED-related infections occurred in 32 envelope patients and 51 control patients (Kaplan-Meier [KM] estimate 1.3% vs 1.9%; hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.41–0.99; P = .046). Any CIED-related infection occurred in 57 envelope patients and 84 control patients (KM estimate 2.1% vs 2.8%; HR 0.69; 95% CI 0.49–0.97; P = .030). System- or procedure-related complications occurred in 235 envelope patients and 252 control patients (KM estimate 8.0% vs 8.2%; HR 0.95; 95% CI 0.79–1.13; P < .001 for noninferiority); the most common were lead dislodgment (1.1%), device lead damage (0.5%), and implant site hematoma (0.4%). Implant site pain occurred less frequently in the envelope group (0.1% vs 0.4%; P = .067). There were no (0.0%) reports of allergic reactions to the components of the envelope (mesh, polymer, or antibiotics). Conclusion: The effects of the TYRX envelope on the reduction of the risk of CIED infection are sustained beyond the first year postprocedure, without an increased risk of complications. © 2020 The Authors
|
|
| 16. |
- Rundström, Hanna, 1972, et al.
(författare)
-
Pacemaker endocarditis during 18 years in Göteborg.
- 2004
-
Ingår i: Scandinavian journal of infectious diseases. - : Informa UK Limited. - 0036-5548 .- 1651-1980. ; 36:9, s. 674-9
-
Tidskriftsartikel (refereegranskat)abstract
- Pacemaker endocarditis is a rare but serious complication. Few studies addressing its treatment have been published. Clinical characteristics and outcome were retrospectively studied in 38 patients with 44 episodes of pacemaker infective endocarditis (PMIE) in Göteborg, during 1984-2001. The male/female ratio of episodes was 27/17 and the mean age 69 y. Transthoracic echocardiography (TTE) showed vegetation in 4/22 (18%) episodes and transoesophageal echocardiography (TEE) in 22/33 (67%). Staphylococci were isolated in 66% of blood cultures. The pacemaker system (PS) was removed in 28 episodes and in 18 of these there were no signs of reinfection at follow-up. In 16 episodes the PS was not removed, and in 13 of these, signs of infection were found at follow-up. Thus, the present study of PMIE showed staphylococci to be predominant causative agents and demonstrated a high diagnostic sensitivity of TEE. According to our results, PM removal rather than conservative treatment should be considered in all cases.
|
|
| 17. |
- Sperzel, Johannes, et al.
(författare)
-
Clinical performance of a ventricular automatic capture verification algorithm.
- 2005
-
Ingår i: Pacing and clinical electrophysiology : PACE. - : Wiley. - 0147-8389 .- 1540-8159. ; 28:9, s. 933-7
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: This study was conducted to evaluate the clinical performance of the ventricular automatic capture feature as implemented in the Insignia I Ultra pacemaker system (Guidant) utilizing a variety of ventricular leads. Currently, the optimal programming of the pacemaker output considers both pacemaker efficiency (prolonging battery longevity) and patient safety (adequate safety margin). The ability of a pacemaker to automatically adjust the ventricular output above the pacing threshold while maintaining the appropriate safety margin has been explored since the early 1970s and is only available today in conjunction with a specific low polarization lead system. METHODS: One hundred and five patients were enrolled from 17 European centers utilizing 31 different types of ventricular leads were followed through their 3-month follow-up visit. There were no restrictions on the type of ventricular leads used. RESULTS: The average mean difference between the commanded autothreshold test (0.652 + 0.335 V) and the manual threshold test (0.651 + 0.335 V) was 0.001 + 0.49 (P < 0.0001). The average mean difference between the ambulatory autothreshold test (0.696 + 0.322 V) and the commanded autothreshold test (0.682 + 0.315 V) was 0.002 + 0.74 (P < 0.0001). Holter recordings confirmed that there were no loss of capture incidences without a backup pulse being delivered. In addition, the mean number of backup pulses delivered in a 24-hour period was less than 0.1% of the total number of paced beats. CONCLUSIONS: This study provided that the automatic capture feature while using a variety of leads accurately determines the ventricular stimulation threshold and safely delivers a backup pulse when required.
|
|
| 18. |
- Sperzel, Johannes, et al.
(författare)
-
Performance evaluation of a right atrial automatic capture verification algorithm using two different sensing configurations.
- 2009
-
Ingår i: Pacing and clinical electrophysiology : PACE. - : Wiley. - 1540-8159 .- 0147-8389. ; 32:5, s. 579-87
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: This acute data collection study evaluated the performance of a right atrial (RA) automatic capture verification (ACV) algorithm based on evoked response sensing from two electrode configurations during independent unipolar pacing. METHODS: RA automatic threshold tests were conducted. Evoked response signals were simultaneously recorded between the RA(Ring) electrode and an empty pacemaker housing electrode (RA(Ring)-->Can) and the electrically isolated Indifferent header electrode (RA(Ring)-->Ind). The atrial evoked response (AER) and the performance of the ACV algorithm were evaluated off-line using each sensing configuration. An accurate threshold measurement was defined as within 0.2 V of the unipolar threshold measured manually. Threshold tests were designed to fail for small AER (< 0.35 mV) or insufficient signal-to-artifact ratio (SAR < 2). Manual threshold measurements were obtained during RA unipolar and bipolar pacing and compared across device indications. RESULTS: Data were collected from 38 patients with RA bipolar leads from four manufacturers. AER signals were analyzed from 34 patients who were indicated for a pacemaker (five), implantable cardioverter-defibrillator (11), or cardiac resynchronization therapy pacemaker (six) or defibrillator (12). The minimum AER amplitude was larger (P < 0.0001) when recorded from RA(Ring)-->Can (1.6+/-0.9 mV) than from RA(Ring)-->Ind (1.3+/-0.8 mV). The algorithm successfully measured the pacing threshold in 96.8% and 91.0% of tests for RA(Ring)-->Can and RA(Ring)-->Ind, respectively. No statistical difference between the unipolar and bipolar pacing threshold was observed. CONCLUSIONS: The RA(Ring)-->Can AER sensing configuration may provide a means of implementing an independent pacing/sensing method for ACV in the RA. RA bipolar pacing therapy based on measured RA unipolar pacing thresholds may be feasible.
|
|
| 19. |
|
|
| 20. |
- Wilkoff, B. L., et al.
(författare)
-
Impact of Cardiac Implantable Electronic Device Infection A Clinical and Economic Analysis of the WRAP-IT Trial
- 2020
-
Ingår i: Circulation-Arrhythmia and Electrophysiology. - : Ovid Technologies (Wolters Kluwer Health). - 1941-3149 .- 1941-3084. ; 13:5
-
Tidskriftsartikel (refereegranskat)abstract
- Background: Current understanding of the impact of cardiac implantable electronic device (CIED) infection is based on retrospective analyses from medical records or administrative claims data. The WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) offers an opportunity to evaluate the clinical and economic impacts of CIED infection from the hospital, payer, and patient perspectives in the US healthcare system. Methods: This was a prespecified, as-treated analysis evaluating outcomes related to major CIED infections: mortality, quality of life, disruption of CIED therapy, healthcare utilization, and costs. Payer costs were assigned using medicare fee for service national payments, while medicare advantage, hospital, and patient costs were derived from similar hospital admissions in administrative datasets. Results: Major CIED infection was associated with increased all-cause mortality (12-month risk-adjusted hazard ratio, 3.41 [95% CI, 1.81-6.41]; P<0.001), an effect that sustained beyond 12 months (hazard ratio through all follow-up, 2.30 [95% CI, 1.29-4.07]; P=0.004). Quality of life was reduced (P=0.004) and did not normalize for 6 months. Disruptions in CIED therapy were experienced in 36% of infections for a median duration of 184 days. Mean costs were $55 547 +/-$45 802 for the hospital, $26 867 +/-$14 893, for medicare fee for service and $57 978 +/-$29 431 for Medicare Advantage (mean hospital margin of -$30 828 +/-$39 757 for medicare fee for service and -$6055 +/-$45 033 for medicare advantage). Mean out-of-pocket costs for patients were $2156 +/-$1999 for medicare fee for service, and $1658 +/-$1250 for medicare advantage. Conclusions: This large, prospective analysis corroborates and extends understanding of the impact of CIED infections as seen in real-world datasets. CIED infections severely impact mortality, quality of life, healthcare utilization, and cost in the US healthcare system.
|
|
