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The study , by Gennaro Giustino , MD , et al ., pooled data for 9,577 patients from six randomized controlled trials , and investigated the efficacy and safety of long-term ( 12 months ) vs . short-term ( 3 or 6 months ) DAP T with aspirin and clopidogrel according to PCI complexity . The primary efficacy endpoint was major adverse cardiac events ( MACE ), defined as the composite of cardiac death , myocardial infarction , or stent thrombosis . The primary safety endpoint was major bleeding . Intention-to-treat was the primary analytic approach .
Results showed 1,680 patients ( 17.5 %) underwent complex PCI and had a higher risk of MACE at the median follow-up time of 392 days compared to the non-complex group . Those patients in the complex PCI group saw significant reductions in MACE with long-term DAPT compared with short-term DAPT . Researchers noted the magnitude of the benefit with long-term DAPT was progressively greater per increase in procedural complexity . However , long-term DAPT was associated with increased risk for major bleeding , irrespective of procedural complexity .
Moving forward , study authors note that “ patients who undergo complex PCI might benefit from upfront longer (> 6 months ) DAPT duration to prevent MACE , irrespective of clinical presentation .” Additionally , “ ad hoc pharmacological strategies to optimize outcomes after complex PCI may warrant prospective randomized investigation .”
Giustino G , Chieffo A , Palmerini T , et al . J Am Coll Cardiol . 2016 ; doi : 10.1016 / j . jacc . 2016.07.760

Study Explores Potential Clinical Implications of THV Thrombosis

New data presented Aug . 28 during the ESC Congress 2016 in Rome offer a closer look at the incidence , potential predictors , and clinical implications of transcatheter heart valve ( THV ) thrombosis following transcatheter aortic valve replacement ( TAVR ).
The study , simultaneously published in JACC , looked at 460 patients undergoing TAVR with the
Edwards Sapien XT or Sapien 3 valves at Aarhus University Hospital in Denmark between January 2011 and January 2016 . Of these patients , 405 ( 88 %) underwent contrast-enhanced multidetector computed tomography ( MDCT ) in addition to transthoracic and transesophageal echocardiography 1 to 3 months after TAVR . The MDCT scans were evaluated for hypoattenuated leaflet thickening indicating THV thrombosis .
Overall results found THV thrombosis in 7 % of patients ( 28 of 405 ). While there was no significant difference in THV thrombosis risk between patients receiving the Edwards Sapien XT and the Sapien 3 valves , study authors did note a difference in risk between patients taking warfarin ( 1.8 %) and those not taking warfarin ( 10.7 %). A larger THV was also associated with an increased THV thrombosis risk ( p = 0.03 ). In multivariable analysis , the use of a 29 mm THV and no post-TAVR warfarin treatment , independently predicted THV thrombosis . Treatment with warfarin effectively reverted THV thrombosis and normalized THV function in 85 % of patients .
“ Although often subclinical , THV thrombosis may have important clinical implications ,” the study authors said . “ Future studies are warranted to assess whether tailored post-TAVR antithrombotic therapy can reduce the incidence of THV thrombosis .”
Hansson NC , Grove EL , Andersen HR , et al . J Am Coll Cardiol . 2016 ; doi : 10.1016 / j . jacc . 2016.08.010

ACC Health Policy Statement Stresses Importance of EHR Interoperability

Participating in Integrating the Healthcare Enterprise ( IHE ) – a unique collaboration of health care professionals and industry focused on improving the way computer systems in health care share information – is crucial to achieving electronic health record ( EHR ) interoperability , according to a new ACC health policy statement published recently in JACC , developed in conjunction with the American Society

“ The lack of interoperability of health information technology prevents the field of health care from realizing the full potential of the Information Age [...].”

— John R . Windle , MD
of Echocardiography , American Society of Nuclear Cardiology , Heart Rhythm Society and Society for Cardiovascular Angiography and Interventions .
“ The lack of interoperability of health information technology ( IT ) prevents the field of health care from realizing the full potential of the Information Age that has revolutionized so many fields of human endeavor ,” write John R . Windle , MD , chair of the writing committee and a member of ACC ’ s Informatics and Health IT Taskforce , and co-authors . “ Using internationally recognized standards , IHE provides a construct to create the technical frameworks to exchange health care data while maintaining the granular syntactic and semantic attributes needed to accommodate the needs of
the diverse consumers of health care information ,” they add . Given the complexity of achieving interoperability , the statement stresses the importance of stakeholders – including medical societies , government agencies and vendors – coming together to share best practices and work towards standardization .
Interoperability describes how effectively clinical data can move between different participants , both human and technological , in the care delivery chain . The authors explain that while achieving interoperability is important for everyone involved in health care , it impacts different groups in different ways . Clinicians and ACC members could see data flowing from outside and within their institutions , increasing the communication necessary to deliver complex care to growing number of people . C-suite leaders can benefit from interoperability by driving down longterm costs using open source solutions to prevent data blocking and limit the expensive interfaces required to move data between clinical silos , eventually breaking down the walls between specialties . For patients , interoperability ensures access to an individual ’ s complete medical record . The authors further explain that this is increasingly important since various clinicians and facilities often contribute to a patient ’ s medical record and a large amount of clinical data can make it difficult to keep track of what has been done where .
“ The ACC believes that meaningful interoperability of data , agnostic of proprietary vendor formatting , is crucial for optimal patient care as well as the many associated activities necessary to support a robust and transparent health care delivery system . IHE serves a unique role and fills a critical gap in pursuit of this goal ,” the statement concludes .
As such , the College has worked with device vendors , medical societies and clinical facilities to develop 14 IHE profiles for cardiology that have been tested and validated at the annual IHE Connectathon testing event .
Moving forward , the writing committee hopes this health policy statement will help members of the C-suite as well as clinical leadership navigate interoperability and leverage IHE to connect various parts of the clinical workflow into a cohesive whole .
Windle JR , Katz AS , Dow J , Jr ., et al . J Am Coll Cardiol . 2016 ; doi : 10.1016 / j . jacc . 2016.04.017
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