Abstract 224: No Difference in Complications or Mortality by Implanted Cardioverter Defibrillator Type in Veterans Enrolled in The Outcomes Among Veterans with Implantable Devices (OVID) Registry

Author(s):  
Preston M Schneider ◽  
Cara N Pellegrini ◽  
Paul Heidenreich ◽  
Edmund Keung ◽  
Barry M Massie ◽  
...  

Introduction: Dual chamber ICD implantation has been associated with higher complication rates than single chamber ICD implantation without associated decrease in morbidity or mortality in prior reports. If this association is present using validated long term outcomes or whether the same is true for cardiac resynchronization therapy defibrillator (CRT-D) devices is not well described. Methods: The OVID registry enrolled 3,918 veterans between 2003 and 2009. Retrospective chart abstraction from enrollment to implant date captured pre- and peri-procedural data. Patients were then followed prospectively until death or study conclusion. Abstraction was done by trained abstractors. Clinical outcomes and mortality were abstracted and validated. Mortality was cross referenced with the social security death index. Association of ICD type (single chamber, dual chamber, CRT-D) with mortality, non-fatal major events (major adverse cardiac events, TIA, stroke, cardiogenic syncope, cardiac hospitalization, device complication or infection, procedural complications), and the composite of mortality and non-fatal events was examined using Cox proportional hazards regression, adjusting for baseline clinical characteristics and comorbidities. Results: There were 786 deaths and 1143 non-fatal major events over 11,290 person years of follow up. In unadjusted analyses, CRT-D was associated with non-fatal major events (HR 1.26, 95% CI 1.09-1.45; p<0.05) and the composite outcome (HR 1.12, 95% CI 1.06-1.35; p<0.05) as was Dual chamber ICD (non-fatal major-HR 1.19, 95% CI 1.03-1.37; p<0.05, composite-HR 1.17, 95% CI 1.04-1.31; p<0.05). No significant difference existed in risk between ICD types in the unadjusted analysis of mortality or for any outcome when adjusted for clinical covariates. Conclusions: Unadjusted analyses showed an association between dual chamber ICD and CRT-D devices and risk of non-fatal major events and the composite outcome versus single chamber ICD implantation. This did not persist when adjusted for clinical characteristics and comorbidities, though we are underpowered for small differences. Further study is needed as prior reports may not have adjusted adequately for clinical covariates and lacked validated outcomes.

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Thomas A Dewland ◽  
Cara N Pellegrini ◽  
Yongfei Wang ◽  
Gregory M Marcus ◽  
Paul D Varosy

Background: Dual chamber implantable cardioverter-defibrillators (ICDs) offer potential advantages over single chamber devices. Definitive evidence demonstrating improved outcomes with dual chamber ICDs is lacking, however, and the choice of such devices remains controversial. The prevalence, predictors, and procedural complication rates of single versus dual chamber devices in patient populations not enrolled in randomized trials are unknown. Methods and Results: Between January 2006 and December 2007, the NCDR ICD Registry recorded 104,049 first-time implantations of single or dual chamber ICDs. Dual chamber devices were implanted in 64,489 patients (62%). After adjusting for potential confounding factors and clustering on patient center using hierarchical logistic regression models, characteristics associated with lower odds of dual chamber ICD implantation included black race (odds ratio (OR), 0.89; 95% confidence interval (CI), 0.85 – 0.93), Medicaid insurance (OR, 0.88; CI, 0.82 – 0.94), diabetes (OR, 0.94; CI, 0.91 – 0.97), and end-stage renal disease (OR, 0.82; CI, 0.76 – 0.89). Complications were more frequent with dual chamber device implantation, including cardiac arrest (0.31% vs. 0.23%, P = 0.01), hematoma (0.92% vs. 0.71%, P < 0.001), pneumothorax (0.53% vs. 0.36%, P < 0.001), pericardial tamponade (0.09% vs. 0.05%, P = 0.01), lead dislodgement (0.88% vs. 0.50%, P < 0.001), and any complication (3.2% vs. 2.1%, P < 0.001). The increased risk of complications associated with dual chamber ICD selection persisted after adjusting for patient demographic characteristics, medical comorbidities, and ICD indication (OR, 1.40; CI, 1.28 – 1.52; P < 0.001). Conclusions: While dual chamber ICD selection is more common than single chamber implantation among patients enrolled in the NCDR ICD Registry, both blacks and patients insured with Medicaid are less likely to receive dual chamber devices. Further investigation is needed to determine whether the benefits of dual chamber ICD therapy outweigh the greater risk of peri-procedural complications.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Ciesielski ◽  
A Slawuta ◽  
A Zabek ◽  
K Boczar ◽  
B Malecka ◽  
...  

Abstract   A single-chamber ICD is a standard method for primary SCD prophylaxis. In patients with chronic atrial fibrillation it does not contribute to the regularization of heart rate, which is crucial for proper treatment. Moreover, to avoid the deleterious effect of right ventricular pacing only minority of the patients with single chamber ICD get the appropriate, recommended dose of beta-blockers. The aim of our study was to assess the efficacy of direct His-bundle pacing in a population of patients with congestive heart failure and chronic atrial fibrillation using upgrade from single chamber to dual-chamber ICD and atrial channel to perform the His-bundle pacing Methods The study population included 39 patients (37 men, 2 women) aged 67.2±9.3 years, with CHF and chronic AF implanted primarily with single chamber ICD with established pharmacotherapy and stable clinical status. Results The echocardiography measurements at baseline and during follow-up were presented in the table: During short period (3–6 months) of follow-up the mean values of EF and LV dimensions significantly improved. This was also accompanied by functional status improvement. Conclusions His-bundle-based pacing in CHF-chronic AF patients contributes to significant echocardiographic and clinical improvement. Standard single-chamber ICD implantation in CHF-chronic AF patients yields only SCD prevention without influence on remodeling process. The physiological pacing contributes to better pharmacotherapy. Funding Acknowledgement Type of funding source: None


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
I Warchol ◽  
A Lubinski ◽  
M Sterlinski ◽  
O Kowalski ◽  
K Goscinska-Bis ◽  
...  

Abstract Background In the Polish ICD Registry population secondary prevention recipients account for over 27%. Despite the evolution of indications for secondary prevention implantable cardioverter defibrillators (ICDs), recommendations regarding the use of ICDs for secondary prevention of sudden cardiac death (SCD) rely on information from a small number of randomized controlled trials that were performed decades ago, with mixed results. Moreover, research on the outcomes after implantations for secondary prevention of ICDs is limited. While dual-chamber devices offer theoretical advantage over single-chamber devices, dual-chamber ICDs (DC-ICDs) were announced not superior to single-chamber (SC-ICDs) in some research. Purpose Therefore, the aim of the study was to evaluate the all-cause mortality among patients from the Polish ICD Registry receiving either a single- or a dual-chamber device for secondary prevention in contemporary clinical practice. Methods All patients enrolled in the Polish ICD Registry from 1995 to 2016 were identified. Patients were included in the study if they were designated as receiving an ICD for secondary prevention of SCD after documented tachycardic arrest, sustained ventricular tachycardia (VT), or syncope. Kaplan-Meier survival analysis was used to assess all-cause mortality. Results In the study population of 3596 ICD recipients (mean age 69±12 years, 81% male, SC-ICD 61%, DC-ICD 39%), during mean follow-up of 79±43 months all-cause mortality rate was higher in the dual-chamber group than in the single chamber group, with a significant difference between the two groups as depicted in Kaplan-Meier curve (p<0,05). The median survival time was 98 months versus 110 months for SC and DC-ICD, respectively. Conclusions This study is the first to describe the characteristics of a national cohort of patients receiving a secondary prevention ICD in such a long follow-up period in contemporary practice. Implantation of a dual-chamber ICD was associated with higher all-cause mortality compared with single chamber devices.


Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Brian Olshansky ◽  
Mark Richards ◽  
Arjun D Sharma ◽  
Paul W Jones ◽  
Nicholas Wold ◽  
...  

Introduction: Recent remote follow-up data analysis suggests that Lower Rate Limit (LRL) programming at 40 beats per minute (bpm) is associated with lower mortality than higher LRL in patients receiving cardiac resynchronization defibrillators (CRT-d) devices. Purpose: We evaluated: 1. if LRL programming in CRT-d devices is based on implanting center or if it varies from patient-to-patient within centers and 2. if LRL programming is associated with survival. Method: The ALTITUDE remote follow-up database was analyzed for dual-chamber CRT-d devices implanted 2006-2011. LRL programming near implant was assessed. Patients were included if LRL remained constant during follow-up. Centers were included with >25 implants. Mortality was determined from the Social Security Death Index. Results: Of 64,482 patients receiving CRT-d devices (not in chronic atrial fibrillation), 56,501 were from centers implanting >25 devices. Of these, 4,683 were implanted in centers where most patients (>75%) received the same LRL (homogeneous); 51,818 were implanted in centers with variable LRL programming (heterogeneous). No difference in overall survival existed between the two approaches to LRL programming. However, in centers that varied LRL programming, LRL<60 bpm was associated with better 5-year survival (p<0.001) (figure). Conclusion: Most patients in the ALTITUDE database received CRT-D devices from centers that vary LRL programming. At these centers, LRL <60 bpm programming is associated with better survival but the mechanism of benefit is unknown. Alternatively, LRL <60 bpm programming for all patients does not confer survival benefit.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Najmul Siddiqi ◽  
Salim Ahmed ◽  
Rohan Bhojwani ◽  
Mohammed Kanj ◽  
Patrick Tchou ◽  
...  

Introduction: Defibrillation threshold (DFT) testing is a routine part of implantable cardiac defibrillator (ICD) placement at most centers. If a patient is found to have a high DFT, many physicians perform system modification by adding subcutaneous or transvenous shocking coil to the ICD in an attempt to lower DFT. It is not clear how patients with system modification fare compared to patients without such modification. Hypothesis: System modification should have an effect of reducing mortality in patients high DFT when compared with those who don’t undergo it. Methods: We retrospectively reviewed demographic and procedural data from 6520 patients who underwent ICD implant at the Cleveland Clinic, between August 1996 and November 2010. The Social Security Death Index was queried to obtain mortality data. High DFT was defined as DFT greater than 25 joules. Among patients with high DFT, survival was compared between those who underwent system modification versus those who did not, using the log-rank test. Results: 191 patients had a high DFT (mean DFT 30.6+/- 3.4J). The types of ICDs were single chamber 64 (33.5%); dual chamber 72 (37.7%) and cardiac resynchronization or CRT-D 55 (28.8%). 120 patients underwent a system modification (mean DFT after modification was 24.3+/- 5.6J). The commonest system modification was subcutaneous coil (70 patients; Medtronic 6996SQ-58). Median follow-up was 1788 days. Kaplan-Meier survival curves of these two groups exhibited no significant difference in mortality between patients with and without system modification (Mantel-Cox Log-rank, p = 0.731). Conclusions: Patients with high DFT at ICD implant managed by system modification have mortality similar to patients without it. This questions the practice of system modification & calls for further analysis.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Ciesielski ◽  
A Slawuta ◽  
K Boczar ◽  
A Zabek ◽  
B Malecka ◽  
...  

Abstract A single-chamber ICD is a standard method for primary SCD prophylaxis. In patients with chronic atrial fibrillation it dose not contribute to the regularization of heart rate, which is crucial for proper treatment. The aim of our study was to assess the efficacy of direct His-bundle pacing in patients with congestive heart failure and chronic atrial fibrillation using upgrade from single chamber to dual-chamber ICD. Methods The study population included 21 patients with CHF and chronic AF implanted primarily with single chamber ICD with etablished pharmacotherapy and stable clinical status. Results The echocardiography measurements at baseline and during ollow-up were presented in the table: Table 1 Baseline Follow-up p-value LVEDD (ms) 67.7±10.7 64.5±8.6 <0.05 EF (%) 27.0±4.8 33.2±6.9 <0.05 NYHA class 2.8±0.6 1.9±0,5 <0.05 During short 4-months of follow-up the mean values of EF and LV dimensions significantly improved. This was also accompanied by functional status improvement. Conclusions His-bundle-based pacing in CHF-chronic AF patients contributes to significant echocardiographic and clinical improvement. Standard single-chamber ICD implantation in CHF-chronic AF patients yields only SCD prevention without influence on remodeling process.


2020 ◽  
Vol 132 (6) ◽  
pp. 1757-1763 ◽  
Author(s):  
Eva M. Wu ◽  
Tarek Y. El Ahmadieh ◽  
Benjamin Kafka ◽  
James P. Caruso ◽  
Om J. Neeley ◽  
...  

OBJECTIVEObjective assessment tests are commonly used to predict the response to ventriculoperitoneal (VP) shunting in patients with normal pressure hydrocephalus (NPH). Whether subjective reports of improvement after a lumbar drain (LD) trial can predict response to VP shunting remains controversial. The goal in this study was to compare clinical characteristics, complication rates, and shunt outcomes of objective and subjective LD responders who underwent VP shunt placement.METHODSThis was a retrospective review of patients with NPH who underwent VP shunt placement after clinical improvement with the LD trial. Patients who responded after the LD trial were subclassified into objective LD responders and subjective LD responders. Clinical characteristics, complication rates, and shunt outcomes between the 2 groups were compared with chi-square test of independence and t-test.RESULTSA total of 116 patients received a VP shunt; 75 were objective LD responders and 41 were subjective LD responders. There was no statistically significant difference in patient characteristics between the 2 groups, except for a shorter length of stay after LD trial seen with subjective responders. The complication rates after LD trial and VP shunting were not significantly different between the 2 groups. Similarly, there was no significant difference in shunt response between objective and subjective LD responders. The mean duration of follow-up was 1.73 years.CONCLUSIONSReports of subjective improvement after LD trial in patients with NPH can be a reliable predictor of shunt response. The currently used objective assessment scales may not be sensitive enough to detect subtle changes in symptomatology after LD trial.


2020 ◽  
Vol 49 (3) ◽  
pp. E11 ◽  
Author(s):  
Yoshifumi Kudo ◽  
Ichiro Okano ◽  
Tomoaki Toyone ◽  
Akira Matsuoka ◽  
Hiroshi Maruyama ◽  
...  

OBJECTIVEThe purpose of this study was to compare the clinical results of revision interbody fusion surgery between lateral lumbar interbody fusion (LLIF) and posterior lumbar interbody fusion (PLIF) or transforaminal lumbar interbody fusion (TLIF) with propensity score (PS) adjustments and to investigate the efficacy of indirect decompression with LLIF in previously decompressed segments on the basis of radiological assessment.METHODSA retrospective study of patients who underwent revision surgery for recurrence of neurological symptoms after posterior decompression surgery was performed. Postoperative complications and operative factors were evaluated and compared between LLIF and PLIF/TLIF. Moreover, postoperative improvement in cross-sectional areas (CSAs) in the spinal canal and intervertebral foramen was evaluated in LLIF cases.RESULTSA total of 56 patients (21 and 35 cases of LLIF and PLIF/TLIF, respectively) were included. In the univariate analysis, the LLIF group had significantly more endplate injuries (p = 0.03) and neurological deficits (p = 0.042), whereas the PLIF/TLIF group demonstrated significantly more dural tears (p < 0.001), surgical site infections (SSIs) (p = 0.02), and estimated blood loss (EBL) (p < 0.001). After PS adjustments, the LLIF group still showed significantly more endplate injuries (p = 0.03), and the PLIF/TLIF group demonstrated significantly more dural tears (p < 0.001), EBL (p < 0.001), and operating time (p = 0.04). The PLIF/TLIF group showed a trend toward a higher incidence of SSI (p = 0.10). There was no statistically significant difference regarding improvement in the Japanese Orthopaedic Association scores between the 2 surgical procedures (p = 0.77). The CSAs in the spinal canal and foramen were both significantly improved (p < 0.001).CONCLUSIONSLLIF is a safe, effective, and less invasive procedure with acceptable complication rates for revision surgery for previously decompressed segments. Therefore, LLIF can be an alternative to PLIF/TLIF for restenosis after posterior decompression surgery.


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