Comparative effectiveness of ceramic-on-ceramic implants in stemmed hip replacement: a multinational study of six national and regional registries

Journal Journal of Bone and Joint Surgery, American Volume
Authors Sedrakyan, Art; Graves, Stephen; Bordini, Barbara; Pons, Miguel; Havelin, Leif; Mehle, Susan; Paxton, Elizabeth; Barber, Thomas; Cafri, Guy
Year Published 2014
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Abstract

BACKGROUND: The rapid decline in use of conventional total hip replacement with a large femoral head size and a metal-on-metal bearing surface might lead to increased popularity of ceramic-on-ceramic bearings as another hard-on-hard alternative that allows implantation of a larger head. We sought to address comparative effectiveness of ceramic-on-ceramic and metal-on-HXLPE (highly cross-linked polyethylene) implants by utilizing the distributed health data network of the ICOR (International Consortium of Orthopaedic Registries), an unprecedented collaboration of national and regional registries and the U.S. FDA (Food and Drug Administration).

METHODS: A distributed health data network was developed by the ICOR and used in this study. The data from each registry are standardized and provided at a level of aggregation most suitable for the detailed analysis of interest. The data are combined across registries for comprehensive assessments. The ICOR coordinating center and study steering committee defined the inclusion criteria for this study as total hip arthroplasty performed without cement from 2001 to 2010 in patients forty-five to sixty-four years of age with osteoarthritis. Six national and regional registries (Kaiser Permanente and HealthEast in the U.S., Emilia-Romagna region in Italy, Catalan region in Spain, Norway, and Australia) participated in this study. Multivariate meta-analysis was performed with use of linear mixed models, with survival probability as the unit of analysis. We present the results of the fixed-effects model and include the results of the random-effects model in an appendix. SAS version 9.2 was used for all analyses. We first compared femoral head sizes of >28 mm and ≤28 mm within ceramic-on-ceramic implants and then compared ceramic-on-ceramic with metal-on-HXLPE.

RESULTS: A total of 34,985 patients were included; 52% were female. We found a lower risk of revision associated with use of ceramic-on-ceramic implants when a larger head size was used (HR [hazard ratio] = 0.73, 95% CI [confidence interval] = 0.60 to 0.88, p = 0.001). Use of smaller-head-size ceramic-on-ceramic bearings was associated with a higher risk of failure compared with metal-on-HXLPE bearings (HR = 1.36, 95% CI = 1.09 to 1.68, p = 0.006). Use of large-head-size ceramic-on-ceramic bearings was associated with a small protective effect relative to metal-on-HXLPE bearings (not subdivided by head size) in years zero to two, but this difference dissipated over the longer term.

CONCLUSIONS: Our multinational study based on a harmonized, distributed network showed that use of ceramic-on-ceramic implants with a smaller head size in total hip arthroplasty without cement was associated with a higher risk of revision compared with metal-on-HXLPE and >28-mm ceramic-on-ceramic implants. These findings warrant careful reflection by regulatory and clinical communities and wide dissemination to patients for informed decision-making regarding such surgery.

National and International Postmarket Research and Surveillance Implementation: Achievements of the International Consortium of Orthopaedic Registries Initiative

Journal The Journal of Bone and Joint Surgery
Authors Sedrakyan, Art; Paxton, Elizabeth; Graves, Stephen; Love, Rebecca; Marinac-Dabic, Danica
Year Published 2014
Link to publication

Nearly every American will be exposed to a medical device during his or her life, and tens of millions of people will be treated with an implantable device. However, regulatory and public health systems in the United States and internationally have critical gaps. The U.S. Food and Drug Administration (FDA) has released a national medical device postmarket surveillance plan, in which the agency identifies as a main priority the goal of promoting the development of national and international medical device registries for selected products. Another top priority of the FDA is the creation of a unique device identification (UDI) system for medical devices in response to a 2007 federal law.

Comparative safety of endovascular and open surgical repair of abdominal aortic aneurysms in low-risk male patients.

Journal Journal of Vascular Surgery
Authors Siracuse, Jeffrey J., Heather L. Gill, Ashley R. Graham, Darren B. Schneider, Peter H. Connolly, Art Sedrakyan, and Andrew J. Meltzer
Year Published 2014
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Objective

The prevalence of significant comorbidities among patients with abdominal aortic aneurysms (AAAs) has contributed to widespread enthusiasm for endovascular AAA repair (EVAR). However, the advantages of EVAR in patients at low risk for open surgical repair (OSR) remain unclear. The objective of this study was to assess perioperative outcomes of EVAR and OSR in low-risk patients.

Methods

Patients undergoing EVAR and OSR for infrarenal AAAs were identified in the 2007 to 2010 National Surgical Quality Improvement Program data sets. AAA-specific risk stratification, by the Medicare aneurysm scoring system, was used to create matched low-risk (score <3) cohorts. Perioperative morbidity and mortality were assessed by crude comparisons of matched groups and regression models.

Results

Of 11,753 elective patients undergoing EVAR, 4339 (37%) were deemed low risk (score <3). A matched cohort of 1576 low-risk patients was developed from a total of 3804 (41%) undergoing OSR. The low-risk cohorts included only male patients and those <75 years of age, without significant cardiac, pulmonary, or vascular comorbidities. Mean age in both low-risk groups was 67 ± 6 years (P = NS). EVAR patients had higher rates of obesity (40% vs 33%; P < .001), diabetes (16% vs 13%; P = .005), history of cardiac intervention (24% vs 19%; P < .001), cardiac surgery (23% vs 20%; P = .02), steroid use (4% vs 2%; P = .002), and bleeding disorders/anticoagulation (9% vs 6%; P = .001) compared with OSR patients. There were no other differences between the matched cohorts. EVAR was associated with reduced 30-day mortality (0.5% vs 1.5%; P < .01) and reduced rates of major complications, including the following: sepsis (0.7% vs 3.2%; P < .01), unplanned intubation (1.0 vs 5.4%; P < .001), pneumonia (0.8% vs 6.1%; P < .001), acute renal failure (0.4% vs 2.7%; P < .001), and early reoperation (3.7% vs 6.0%; P < .001). Furthermore, EVAR was associated with reduced perioperative morbidity across organ systems, including venous thromboembolism (0.1% vs 0.3%; P = .001), transfusion requirement of more than 4 units (2.0% vs 13.0%; P < .001), cardiac arrest (0.2 vs 0.8; P = .001), neurologic deficits (0.2% vs 0.5%; P = .032), and urinary tract infections (1.2% vs 2%; P = .02).

Conclusions

Our results demonstrate that even among those male patients at low risk for OSR on the basis of comorbidities, EVAR is associated with reduced perioperative mortality and major complications. Whereas clinical decisions must account for safety and long-term effectiveness, the short-term benefit of EVAR is evident even among male patients at the lowest risk for OSR.

Comparative effectiveness of drug-eluting stents on long-term outcomes in elderly patients treated for in-stent restenosis: a report from the National Cardiovascular Data Registry.

Journal Catheterization and Cardiovascular interventions
Authors Kutcher, Michael A.; Brennan, J. Matthew; Rao, Sunil V.; Dai, David; Anstrom, Kevin J.; Mustafa, Nowwar; Sedrakayan, Art
Year Published 2014
Link to Publication

Abstract

OBJECTIVE:

We assessed the long-term outcomes of elderly patients who had in-stent restenosis (ISR) treated with drug-eluting stents (DES) compared with other treatment strategies.

BACKGROUND:

Elderly patients with ISR represent a vulnerable group of which little is known regarding the safety and efficacy of repeat percutaneous coronary intervention (PCI).

METHODS:

We analyzed patients ≥ 65 years of age who underwent PCI for ISR in the National Cardiovascular Data Registry(®) from 2004 to 2008. Death, myocardial infarction (MI), revascularization, stroke, and bleeding were assessed for up to 30 months by a linkage with Medicare rehospitalization claims.

RESULTS:

Of 43,679 linked patients, 30,012 were treated with DES, 8,277 with balloon angioplasty (BA), and 4,917 with bare metal stents (BMS). Compared with BMS, DES use was associated with a lower propensity score-matched (PM) risk of death (hazard ratio [HR] 0.72; 95% confidence interval [CI] 0.66-0.80, P < 0.001), MI (HR 0.81; 95% CI 0.70-0.93, P = 0.003), and revascularization (HR 0.90; 95% CI 0.82-1.00, P = 0.055). Compared with BA, DES use was associated with a lower PM risk of death (HR 0.82; 95% CI 0.76-0.89, P < 0.001) and revascularization (HR 0.86; 95% CI 0.80-0.93, P < 0.001), but no statistically significant difference across other endpoints. There were no significant differences in long-term outcomes for BA compared with BMS.

CONCLUSIONS:

There was lower mortality and reduced risk for MI, revascularization, and stroke, but a similar rate of bleeding with DES compared with other modalities. Our results indicate that DES use is a comparatively effective strategy to treat elderly patients with ISR.

The international registry infrastructure for cardiovascular device evaluation and surveillance

Journal JAMA
Authors Sedrakyan, Art; Marinac-Dabic, Danica; Holmes, David
Year Published 2013
Link to publication

Since the creation of the US Food and Drug Administration (FDA) Medical Device Epidemiology Network (MDEpiNet), there has been an increasing FDA commitment to support the development of a global medical device research and surveillance infrastructure. The FDA’s new postmarket surveillance plan strengthens this commitment and highlights the importance of national and international registries, and multi-stakeholder involvement for ensuring this commitment is fulfilled.This Viewpoint summarizes the potential for development of an International Consortium of Cardiovascular Registries, modeled on a consortium established for orthopedic devices, as an initial project in the realm of cardiovascular devices with the focus on transcatheter aortic valve replacement (TAVR).