The purpose of this study was to evaluate the incidence, predictors, and clinical outcomes of permanent pacemaker (PPM) implantation following transcatheter aortic valve replacement (TAVR).
...Conduction abnormalities leading to PPM implantation are common complications following TAVR. Whether PPM placement can be predicted or is associated with adverse outcomes is unclear.
A retrospective cohort study of patients undergoing TAVR in the United States at 229 sites between November 2011 and September 2014 was performed using the Society of Thoracic Surgeons/American College of Cardiology TVT Registry and the Centers for Medicare and Medicaid Services database.
PPM placement was required within 30 days of TAVR in 651 of 9,785 patients (6.7%) and varied among those receiving self-expanding valves (25.1%) versus balloon-expanding valves (4.3%). Positive predictors of PPM implantation were age (per 5-year increment, odds ratio: 1.07; 95% confidence interval CI: 1.01 to 1.15), prior conduction defect (odds ratio: 1.93; 95% CI: 1.63 to 2.29), and use of self-expanding valve (odds ratio: 7.56; 95% CI: 5.98 to 9.56). PPM implantation was associated with longer median hospital stay (7 days vs. 6 days; p < 0.001) and intensive care unit stay (56.7 h vs. 45.0 h; p < 0.001). PPM implantation was also associated with increased mortality (24.1% vs. 19.6%; hazard ratio HR: 1.31; 95% CI: 1.09 to 1.58) and a composite of mortality or heart failure admission (37.3% vs. 28.5%; hazard ratio HR: 1.33; 95% CI: 1.13 to 1.56) at 1 year but not with heart failure admission alone (16.5% vs. 12.9%; HR: 1.23; 95% CI: 0.92 to 1.63).
Early PPM implantation is a common complication following TAVR, and it is associated with higher mortality and a composite of mortality or heart failure admission at 1 year.
The purpose of this study was to identify predictors and clinical implications of permanent pacemaker (PPM) implantation after transcatheter aortic valve replacement (TAVR).
Cardiac conduction ...disturbances requiring PPM are a frequent complication of TAVR. However, limited data is available regarding this complication after TAVR with a balloon-expandable valve.
The study included patients without prior pacemaker who underwent TAVR in the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry and investigated predictors and clinical effect of new PPM.
Of 2,559 TAVR patients, 586 were excluded due to pre-existing PPM. A new PPM was required in 173 of the remaining 1,973 patients (8.8%). By multivariable analysis, predictors of PPM included right bundle branch block (odds ratio OR: 7.03, 95% confidence interval CI: 4.92 to 10.06, p < 0.001), prosthesis diameter/left ventricular (LV) outflow tract diameter (for each 0.1 increment, OR: 1.29, 95% CI: 1.10 to 1.51, p = 0.002), LV end-diastolic diameter (for each 1 cm, OR: 0.68, 95% CI: 0.53 to 0.87, p = 0.003), and treatment in continued access registry (OR: 1.77, 95% CI: 1.08 to 2.92, p = 0.025). Patients requiring PPM had a longer mean duration of post-procedure hospitalization (7.3 ± 2.7 days vs. 6.2 ± 2.8 days, p = 0.001). At 1 year, new PPM was associated with significantly higher repeat hospitalization (23.9% vs. 18.2%, p = 0.05) and mortality or repeat hospitalization (42.0% vs. 32.6%, p = 0.007). There was no difference between groups in LV ejection fraction at 1 year.
PPM was required in 8.8% of patients without prior PPM who underwent TAVR with a balloon-expandable valve in the PARTNER trial and registry. In addition to pre-existing right bundle branch block, the prosthesis to LV outflow tract diameter ratio and the LV end-diastolic diameter were identified as novel predictors of PPM after TAVR. New PPM was associated with a longer duration of hospitalization and higher rates of repeat hospitalization and mortality or repeat hospitalization at 1 year. (THE PARTNER TRIAL: Placement of AoRtic TraNscathetER Valves Trial; NCT00530894).
Leadless Cardiac Pacemakers: Back to the Future Miller, Marc A; Neuzil, Petr; Dukkipati, Srinivas R ...
Journal of the American College of Cardiology,
2015-Sep-08, 20150908, Letnik:
66, Številka:
10
Journal Article
Recenzirano
Odprti dostop
Despite significant advances in battery longevity, lead performance, and programming features since the first implanted permanent pacemaker was developed, the basic design of cardiac pacemakers has ...remained relatively unchanged over the past 50 years. Because of inherent limitations in their design, conventional (transvenous) pacemakers are prone to multiple potential short- and long-term complications. Accordingly, there has been intense interest in a system able to provide the symptomatic and potentially lifesaving therapies of cardiac pacemakers while mitigating many of the risks associated with their weakest link-the transvenous lead. Leadless cardiac pacing represents the future of cardiac pacing systems, similar to the transition that occurred from the use of epicardial pacing systems to the familiar transvenous systems of today. This review summarizes the current evidence and potential benefits of leadless pacing systems, which are either commercially available (in Europe) or under clinical investigation.
Professional practice guidelines recommend that pacemaker recipients be followed regularly. However, the majority of scheduled ambulatory visits is unproductive and imposes a heavy burden on the ...health-care system.
The COMPAS randomized, multicentre, non-inferiority trial examined the safety of long-term remote monitoring of pacemakers. Between December 2005 and January 2008, 538 patients were randomly assigned to remote monitoring follow-up (active group) vs. standard care (control group). The primary objective was to confirm that the proportion of patients who experienced at least one major adverse event (MAE), including all-cause death and hospitalizations for device-related or cardiovascular adverse events, was not >7% higher in the active than in the control group. MAE-free survivals and quality of life were compared in both groups. The characteristics of the study groups were similar. Over a follow-up of 18.3 months, 17.3% of patients in the active and 19.1% in the control group experienced at least one MAE (P < 0.01 for non-inferiority). Hospitalizations for atrial arrhythmias (6 vs. 18) and strokes (2 vs. 8) were fewer (P < 0.05), and the number of interim ambulatory visits was 56% lower (P < 0.001) in the active than the control group. Changes in pacemaker programming or drug regimens were made in 62% of visits in the active vs. 29% in the control group (P < 0.001). Quality of life remained unchanged in both groups.
Remote monitoring was a safe alternative to conventional care and significantly lowered the number of ambulatory visits during long-term follow-up of permanently paced patients. ClinicalTrials.gov identifier: NCT00989326.
A dual-chamber pacemaker (DDD/R) for a sinus node disease is sometimes referred to as a physiological pacemaker as it maintains atrioventricular synchrony, however several clinical trials have proved ...its inferiority to a nonphysiological single-chamber ventricular back-up pacing.
A subject of the study is a 74-year-old woman with a sick sinus syndrome (SSS) and a previously implanted physiological DDD/R pacemaker. The SSS was diagnosed because of patient's very slow sinus rhythm of about 36 bpm, and due to several episodes of dizziness. After the DDD/R implantation the percentage of atrial pacing approached 100%, with almost none ventricular pacing.
Sick sinus syndrome, complete Bachmann's bundle block, atrial fibrillation, atrial flutter.
The patient was previously implanted with a physiological DDD/R pacemaker. Several years after the implantation, the atrial fibrillation was diagnosed and the pulmonary vein isolation was then performed by cryoablation. During the follow-up after pulmonary vein isolation, the improvement of mitral filling parameters was assessed using echocardiography. Shortly thereafter the patient developed the persistent paroxysm of a typical atrial flutter which was successfully terminated using a radiofrequency ablation. No recurrence thereof has been observed ever since (24 months).
The atrial electrode of the pacing system was implanted within the low interatrial septal region that resulted in a reduced P-wave duration compared to native sinus rhythm P-waves. The said morphology was deformed because of the complete Bachmann bundle block. That approach, despite a nonphysiological direction of an atrial activation, yielded relatively short P-waves (paced P-wave: 179 ms vs intrinsic sinus P-wave: 237 ms). It also contributed to a significantly shorter PR interval (paced PR: 204 ms vs sinus rhythm PR: 254 ms).
The authors took into consideration different aspects of alternative right atrial pacing sites. This report has shown that in some patients with a sinus node disease, low interatrial septal pacing can reduce the P-wave duration but does not prevent from the development of atrial arrhythmias.
Abstract Objective(s) To assess the impact of univentricular versus biventricular pacing (BiVP) on systemic ventricular function in patients with congenitally corrected transposition of the great ...arteries (ccTGA). Methods We performed a retrospective review of all patients with a diagnosis of ccTGA who underwent pacemaker insertion. From 1993 to 2014, 53 patients were identified from the cardiology database and surgical records. Results Overall mortality was 7.5% (n = 4). One patient required transplantation and 3 late deaths occurred secondary to end-stage heart failure. Median follow-up was 3.7 years (range, 4 days to 22.5 years). Twenty-five (47%) underwent univentricular pacing only, of these, 8 (32%) developed significant systemic ventricular dysfunction. Twenty-eight (53%) received BiVP, 17 (26%) were upgraded from a dual-chamber system, 11 (21%) received primary BiVP. Fourteen (82%) of the 17 undergoing secondary BiVP demonstrated systemic ventricular dysfunction at the time of pacer upgrade, with 7 (50%) demonstrating improved systemic ventricular function after pacemaker upgrade. Overall, 42 (79%) patients underwent univentricular pacing, with 22 (52%) developing significant systemic ventricular dysfunction. In contrast, the 11 (21%) who received primary BiVP had preserved systemic ventricular function at latest follow-up. Conclusions Late-onset systemic ventricular dysfunction is a major complication associated with the use of univentricular pacing in patients with ccTGA. All patients with ccTGA who develop heart block should undergo primary biventricular pacing, as this prevents late systemic ventricular dysfunction. Preemptive placement of BiVP leads at the time of anatomical repair or other permanent palliative procedure will facilitate subsequent BiVP should heart block develop.
A worldwide cardiac pacing and implantable cardioverter‐defibrillator (ICD) survey was undertaken for calendar year 2009 and compared to a similar survey conducted in 2005. There were contributions ...from 61 countries: 25 from Europe, 20 from the Asia Pacific region, seven from the Middle East and Africa, and nine from the Americas. The 2009 survey involved 1,002,664 pacemakers, with 737,840 new implants and 264,824 replacements. The United States of America (USA) had the largest number of cardiac pacemaker implants (225,567) and Germany the highest new implants per million population (927). Virtually all countries showed increases in implant numbers over the 4 years between surveys. High‐degree atrioventricular block and sick sinus syndrome remain the major indications for implantation of a cardiac pacemaker. There remains a high percentage of VVI(R) pacing in the developing countries, although compared to the 2005 survey, virtually all countries had increased the percentage of DDDR implants. Pacing leads were predominantly transvenous, bipolar, and active fixation. The survey also involved 328,027 ICDs, with 222,407 new implants and 105,620 replacements. Virtually all countries surveyed showed a significant rise in the use of ICDs with the largest implanter being the USA (133,262) with 434 new implants per million population. This was the largest pacing and ICD survey ever performed, because of mainly a group of loyal enthusiastic survey coordinators. It encompasses more than 80% of all the pacemakers and ICDs implanted worldwide during 2009. (PACE 2011; 34:1013–1027)
A number of nonischemic conditions including myocarditis, pulmonary embolism, acute and chronic heart failure, and sepsis may be associated with elevated troponin levels (1,2), although they may ...include supply-demand imbalance and thus at least some element of ischemia. ...there remains the possibility that 60 min of pacing produced myocyte necrosis of a small number of cells without lactate production as measured in this study. ...the conclusion that ischemia alone caused the increase in hs-cTnT levels is not fully substantiated by the study findings.\n Thus, proteolysis to create small fragments could allow these to pass through a cellular membrane with normal membrane integrity.
Abstract
Based on a long-standing voluntary registry founded by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS), well-defined data of all cardiac, thoracic, and vascular surgery ...procedures performed in 78 German heart surgery departments during the year 2016 are analyzed. In 2016, a total of 103,128 heart surgery procedures (implantable defibrillator, pacemaker, and extracardiac procedures excluded) were submitted to the registry. Approximately 15.7% of the patients were at least 80 years of age, resulting in an increase of 0.9% compared with the data of 2015. For 37,614 isolated coronary artery bypass grafting procedures (relationship on-/off-pump 4.4:1), an unadjusted in-hospital mortality of 2.9% was observed. Concerning the 33,451 isolated heart valve procedures (including 11,701 catheter-based procedures), the unadjusted in-hospital mortality was 4.3%.
This annual updated registry of the GSTCVS represents voluntary public reporting by accumulating actual information for nearly all heart surgical procedures in Germany, describes advancements in heart medicine, and is a basis for internal and external quality assurances for all participants. In addition, the registry demonstrates that the provision of cardiac surgery in Germany is appropriate and patients are treated nationwide at all times.
Despite advances in antiarrhythmia therapies, ventricular tachycardia (VT) is a leading cause of sudden cardiac death. Investigation into the characteristics and new treatments for this arrhythmia is ...required to improve outcomes and a reproducible model of VT would be useful in these endeavors. We therefore created a canine model of ischemia-induced VT.
A pacing lead was implanted in the right ventricle in canines (n = 13) and the left anterior descending artery was occluded in two locations for 2 h and subsequently released to create an ischemia-reperfusion injury. In the 10 dogs that survived the first 48 h following the initial study, a terminal study was conducted 4-7 d later and VT was induced using premature stimulation or burst pacing through the right ventricle lead. The arrhythmia was terminated using either antitachycardia pacing or a defibrillatory shock. Multiple inductions into sustained VT were attempted.
Sustained VT was induced in eight of 10 dogs with an average cycle length of 335 ± 70 bpm. Multiple episodes of VT were induced. Episodes of VT exhibited different electrocardiogram morphologies and cycle lengths in individual animals.
This canine model provides a consistent technique for inducing multiple episodes of sustained VT. It may be useful for investigating VT mechanisms and testing novel therapeutics and treatments for patients with VT.