1. There are three fundamental types of medical research: (1) Basic science research which probes
the biologic process and greatly improves our knowledge of biology in general and a disease
process in particular. However, the findings from this type of research, even if it leads directly to
drug development may not be implemented in clinical care for 10-20 years in most cases. (2)
Pharmaceutical and device vendor/manufacturer research in its latter stages is performed for the
purpose of gaining FDA approval for the marketing of a product. This type of multi-million or in
some cases billion dollar research is designed, funded, and conducted by industry. These studies
must have a very high likelihood of demonstrating a favorable result for the manufacturer’s
product for the effort and expense to be undertaken. Keep in mind that it is believed that
approximately 75-90% of national professional society treatment guidelines in cardiology
(American Heart Association, American College of Cardiology) are based upon the results of
pharmaceutical and device industry research. (3) Physician-initiated or investigator-initiated
clinical research is designed, conducted, funded, and published by a physician-scientist. This
type of research is performed for the purpose of improving patient care and clinical outcomes
using availableor approved medications, medical devices, or treatment strategies. The results of
physician-initiated research, if favorable, may be implemented immediately. In addition, negative
results from investigator-initiated studies are also reported which may not be true of industry-
initiated research.

2. The purpose of the ERADICATEStudyisto determine the radiationexposure forpatientsundergoing
nuclearand non-nuclearcardiovascularstress-testingata single institutionbetweenJanuary2003 and
December2012.
To determine the relative contributionof nuclearstresstestinganddiagnosticcoronaryangiographyto
the total diagnosticradiationexposure of acardiovascularpatientpopulationovera10 yearperiod.
For patientsundergoingcardiacstresstestingthe radiationexposurereceivedfromanuclear-based
stresstestrepresentsasignificantportion(37%) of the cumulative diagnosticradiationexposure during
a ten-yearperiod(includingcardiacandnon-cardiacdiagnosticprocedures).
Conclusions:Adoptionof astress-firstorstress-onlyprotocolfornuclear-basedcardiacstresstesting
resultsina significantreductioninunnecessaryradiationexposure forpatientsundergoingcardiac
stresstesting(from37% to 25% of cumulative dose andisdependentoninstitutional SPECTnormal
rate).
Background:The presence of a permanentpacemakerorimplantedcardioverter-defibrillator(ICD) has
longbeena contraindicationtomagneticresonanceimaging(MRI). However,the risktobothpatient
and device hasneverbeensufficientlyevaluatedinalarge-scale study.
Methods:Patientswere referredforclinically-indicatednon-thoracicMRI.PacemakerandICD
interrogationwasperformedpre- andpost-MRIusingastandardizedprotocol.Deviceswere
appropriatelyreprogrammedduringthe procedure.PacemakerdependentICDpatientswere excluded.
Primaryendpointswere death,generator/leadfailure,inducedventricularoratrial arrhythmiaor
electrical reset.Secondaryendpointswere device parameterchanges.
Results:Clinically-indicatednon-thoracicMRIwas performedin1500 patients(1000 pacemakers,500
ICDs) at 21 clinical centers.Nodeaths,generator/leadfailures,lossesof capture,orventricular
arrhythmiasoccurredduringthe scan. One ICD generatorrequiredreplacementwhentachytherapywas
inappropriatelyactive duringthe exam.Six episodesof self-terminatingatrial fibrillation(<49hours) and
6 casesof partial electrical resetwere observed.A change inpacingleadimpedance of ≥50Ω occurredin
3% of pacemakersand4% of ICDs. A decrease of ≥ 50% in P-wave amplitude occurredin5pacemakers
and 1 ICD.A decrease of ≥25% in R-wave amplitudeoccurredin4% of pacemakersand2% of ICDs, and a
decrease of ≥50% in1 ICD.A pacingthresholdincrease ≥0.5V occurredin1% of pacemakerandICD
leads.

3. Conclusions:Clinically-indicatednon-thoracicMRIat 1.5T maybe performedforpatientswithnon-MRI
conditional devicesatnodetectable riskwhenthe device isappropriatelyprogrammedduringthe exam.
Background:Intravascularultrasound(IVUS) isaninvasive imagingtechniqueusedtovisualize coronary
cross-sectional anatomy.Several studieshave examinedthe role of IVUS-guidedstentplacementwith
varyingclinical restenosisrates.However,differentIVUScriteriaforoptimal stentplacementwere used
ineach study.To testthe hypothesisthatIVUS-guidedstentplacementresultsinalowerrate of target
lesionrevascularizationthe presenttrial wasinitiatedusingprespecifiedIVUScriteriaforprocedure
success.
Methodsand Results:The AngiographyVersusIntravascularultrasound-Directed(AVID) stentplacement
studyisa multicenterrandomizedclinical trial designedtodetermine the role of IVUSduringelective
coronary stentplacementinnative coronaryarteriesaswellasbypassgrafts.IVUScriteriafor optimal
stentplacement(expansion,appositionandlackof dissection)hadbeenpreviouslytestedinapilottrial.
Assessmentof the primaryendpointwasdeterminedbyclinical follow-upwithoutrepeatangiography.
In an intention-to-treatanalysis,the 12-monthtargetlesionrevascularizationrate,whichwasthe
study’sprimaryoutcome variable,waslowerinthe IVUS-directedtreatmentgroupcomparedtothe
angiographydirectedgroup(8.1%vs.12.0%, P=0.08). Ina per-protocol analysis,excludingprotocol
violationsof adistal referencevessel of <2.5 mm, the 12-month rate of targetlesionrevascularization
was 4.9% inthe IVUS-directedgroupand12.4% in the Angiography-guidedgroup(P=0.01).
Conclusions:IVUS-directedstentplacementresultsinlargeracute stentdimensionswithoutanincrease
incomplications,andsignificantlylower12-monthTLRrates for vessels>2.5mm byangiography,vein
grafts,and vesselswithhigh-gradepreprocedure stenosis.

4. Background:To determine if anaggressive approachtocoronaryrevascularizationwithoversized
balloonsiscounterproductive,we studiedthe effectof balloon-to-artery(B:A) ratiosonneointimal
hyperplasiafollowingstentplacementinporcine coronaryarteries.
Methodsand Results:A porcine coronaryoverstretchmodel wasusedtodetermine the effectof varying
B:A ratioson neointimalgrowthafterintravascularultrasound(IVUS)-guidedprimarystentplacement.
Vesselswererandomlyassignedtoone of five B:A ratiosbetween1.0and 1.4 to 1. IVUS imagingwas
performedpre- andpost-stentplacementandat28-day follow-up.Quantitative IVUSmeasurementsof
stent,vessel lumen,andneointimal diameterandareawere made every1 mm alongthe stentlength.
Volumeswere calculatedusingSimpson’srule.Sixtyvesselsin33 animalswere treatedwithcoronary
stentplacement.StentrecoilincreasedwithincreasingB:A ratio(linearregressiontestforslope,
P=.003). Neointimal volumeincreasedwithincreasingB:A ratio(P<0.001) andwas independentof vessel
size.Evenminorvessel overstretch(B:A ratioof 1.1-to-1) resultedinneointimal hyperplasia.In-stent
volume stenosisandmaximumcross-sectional areastenosisalsoincreasedwithincreasingB:A ratio
(P=.001 andP<.001, respectively) andwere independentof vessel .Neointimal growthextendedbeyond
the stentedge (2.58±2.09 mm),increasedwithincreasingB:A ratio(P<.001),and wasindependentof
vessel size.
Conclusion:Inaporcine model of IVUS-guidedprimarystentplacement,in-stentneointimalvolumewas
stronglyassociatedwithincreasingballoon-to-arteryratioandwasindependentof vesselsize.The
clinical implicationisthatcareful matchingof vesselandstentdiametersbyIVUSmayminimize
neointimal hyperplasia.

5. The Left Main IVUSRegistryResults:A significantleftmainstenosiswasfoundin47% of patients withan
inconclusiveangiogramwhowere theneligible forCABG/LeftMainPCI.
Purpose:Todetermine if IVUSissuperiortoangiographyforthe evaluationof inconclusive angiogram
inthe settingof minimal diseasebyangiography(<50% stenosis).
For patientswithaninconclusivecoronaryangiogram(<50%),asignificantstenosiswasidentifiedin33%
of patientsbyIVUS.
Angiographiclesionlocation,diameter,andcalciumcontentwere predictive of asignificantstenosis
whenan inconclusive lesionwasevaluatedbyIVUS.
Lesionseveritybyangiographywasnotpredictive of asignificantstenosisdetectedbyIVUS(andneed
for revascularization).
Whenangiographyisnon-diagnostic(stenosis<50%),IVUSisan essential techniqueforthe
identificationof clinicallyimportantleftmaincoronarydisease.