Claims-based surveillance for reintervention after endovascular aneurysm repair among non-Medicare patients

Journal Journal of Vascular Surgery
Authors Columbo JA, Kang R, Hoel AW, Kang J, Leinweber KA, Tauber KS, Hila R, Ramkumar N, Sedrakyan A, Goodney PP.
Year Published 2019
Link to publication



The accurate measurement of reintervention after endovascular aneurysm repair (EVAR) is critical during postoperative surveillance. The purpose of this study was to compare reintervention rates after EVAR from three different data sources: the Vascular Quality Initiative (VQI) alone, VQI linked to Medicare claims (VQI-Medicare), and a “gold standard” of clinical chart review supplemented with telephone interviews.


We reviewed the medical records of 729 patients who underwent EVAR at our institution between 2003 and 2013. We excluded patients without follow-up reported to the VQI (n = 68 [9%]) or without Medicare claims information (n = 114 [16%]). All patients in the final analytic cohort (n = 547) had follow-up information available from all three data sources (VQI alone, VQI linked to Medicare, and chart review). We then compared reintervention rates between the three data sources. Our primary end points were the agreement between the three data sources and the Kaplan-Meier estimated rate of reintervention at 1 year, 2 years, and 3 years after EVAR. For gold standard assessment, we supplemented chart review with telephone interview as necessary to assess reintervention.


VQI data alone identified 12 reintervention events in the first year after EVAR. Chart review confirmed all 12 events and identified 18 additional events not captured by the VQI. VQI-Medicare data successfully identified all 30 of these events within the first year. VQI-Medicare also documented four reinterventions in this time period that did not occur on the basis of patient interview (4/547 [0.7%]). The agreement between chart review and VQI-Medicare data at 1 year was excellent (κ = 0.93). At 3 years, there were 81 (18%) reinterventions detected by VQI-Medicare and 70 (16%) detected by chart review for a sensitivity of 92%, specificity of 96%, and κ of 0.80. Kaplan-Meier survival analysis demonstrated similar reintervention rates after 3 years between VQI-Medicare and chart review (log-rank, P = .59).


Chart review after EVAR demonstrated a 6% 1-year and 16% 3-year reintervention rate, and almost all (92%) of these events were accurately captured using VQI-Medicare data. Linking VQI data with Medicare claims allows an accurate assessment of reintervention rates after EVAR without labor-intensive physician chart review.

Long-Term Clinical Outcomes of Silzone Era St. Jude Medical Mechanical Heart Valves

Journal Journal of Heart Valve Disease
Authors Brennan JM, Zhao Y, Williams J, O’Brien S, Dokholyan R, Gammie J, Edwards F, Loyo-Berrios N, Canos D, Gross T, Marinac-Dabic D, Peterson E.
Year Published 2015
Link to publication



Since the voluntary recall of St. Jude Medical (SJM) Silzone impregnated heart valves, no large-scale study has examined their long-term outcomes.


Using Medicare-linked records from the Society of Thoracic Surgeons Adult Cardiac Surgery Database (1993-2004), the clinical outcomes were evaluated through eight years among those patients who received SJM mechanical heart valves during the Silzone era (March 1998 to December 1999; n = 3,775), relative to those in both the pre-Silzone era (January 1993 to February 1998; n = 13,570) and the post-Silzone era (January 2000 to December 2004; n = 6,882). An inverse probability weighting was used to balance the observed differences in case mix.


During the Silzone era, 79% of all implanted mechanical heart valves were manufactured by SJM. By eight years post-implantation, the most common adverse events in this Medicare-linked cohort (median age 71 years) were death (43.5%) and thromboembolism (14.7%), while valve reoperation (1.7%) and endocarditis (1.4%) were less common. Patients treated during the Silzone era experienced a lower associated risk of mortality to eight years than those in both the pre-Silzone era (adjusted hazards ratio (HR) 0.93, 95% confidence interval (CI) 0.88-0.98) and post-Silzone era (adjusted HR 0.92, CI 0.67-0.98), while the adjusted eight-year risks of reoperation, thromboembolism and endocarditis were similar across the three eras for the overall cohort and among both aortic valve and mitral valve patients.


Medicare patients who received SJM mechanical heart valves during the Silzone era experienced similar clinical outcomes as those treated before or after the Silzone era. These data do not substantiate continued public health concerns associated with Silzone era valve prostheses among older individuals.

Hospice use following implantable cardioverter-defibrillator implantation in older patients: results from the National Cardiovascular Data Registry

Journal Circulation
Authors Kramer D, Reynolds M, Normand S-L, Parzynski C, Spertus J, Mor V, Mitchell S.
Year Published 2016
Link to publication



Older recipients of implantable cardioverter-defibrillators (ICDs) are at increased risk for short-term mortality in comparison with younger patients. Although hospice use is common among decedents aged >65, its use among older ICD recipients is unknown.

Methods and Results—

Medicare patients aged >65 matched to data in the National Cardiovascular Data Registry – ICD Registry from January 1, 2006 to March 31, 2010 were eligible for analysis (N=194 969). The proportion of ICD recipients enrolled in hospice, cumulative incidence of hospice admission, and factors associated with time to hospice enrollment were evaluated. Five years after device implantation, 50.9% of patients were either deceased or in hospice. Among decedents, 36.8% received hospice services. The cumulative incidence of hospice enrollment, accounting for the competing risk of death, was 4.7% (95% confidence interval [CI], 4.6%–4.8%) within 1 year and 21.3% (95% CI, 20.7%–21.8%) at 5 years. Factors most strongly associated with shorter time to hospice enrollment were older age (adjusted hazard ratio, 1.77; 95% CI, 1.73–1.81), class IV heart failure (versus class I; adjusted hazard ratio, 1.79; 95% CI, 1.66–1.94); ejection fraction <20 (adjusted hazard ratio, 1.57; 95% CI, 1.48–1.67), and greater hospice use among decedents in the patients’ health referral region.


More than one-third of older patients dying with ICDs receive hospice care. Five years after implantation, half of older ICD recipients are either dead or in hospice. Hospice providers should be prepared for ICD patients, whose clinical trajectories and broader palliative care needs require greater focus.

Geographic and temporal variation in implanted electric devices to treat heart failure

Journal Journal of the American Heart Association
Authors L.A. Hatfield, D. B. Kramer, M. Volya, M. Reynolds, and S-L. T. Normand
Year Published 2016
Link to publication



Cardiac implantable electric devices are commonly used to treat heart failure. Little is known about temporal and geographic variation in use of cardiac resynchronization therapy (CRT) devices in usual care settings.

Methods and Results

We identified new CRT with pacemaker (CRT‐P) or defibrillator generators (CRT‐D) implanted between 2008 and 2013 in the United States from a commercial claims database. For each implant, we characterized prior medication use, comorbidities, and geography. Among 17 780 patients with CRT devices (median age 69, 31% women), CRT‐Ps were a small and increasing share of CRT devices, growing from 12% to 20% in this study period. Compared to CRT‐D recipients, CRT‐P recipients were older (median age 76 versus 67), and more likely to be female (40% versus 30%). Pre‐implant use of β‐blockers and angiotensin‐converting enzyme inhibitors or angiotensin II receptor blockers was low in both CRT‐D (46%) and CRT‐P (31%) patients. The fraction of CRT‐P devices among all new implants varied widely across states. Compared to the increasing national trend, the share of CRT‐P implants was relatively increasing in Kansas and relatively decreasing in Minnesota and Oregon.


In this large, contemporary heart failure population, CRT‐D use dwarfed CRT‐P, though the latter nearly doubled over 6 years. Practice patterns vary substantially across states and over time. Medical therapy appears suboptimal in real‐world practice.