
February8, 2019 
LarryChan HAPG –Division ofPractitionerServices(DPS) Centers for Medicare& Medicaid Services C4-04-27 7500 Security Blvd Baltimore, MD 21224 
(410) 786-6864 Larry.Chan@cms.hhs.gov 
RE:MedicareProgram;RevisionstoPaymentPoliciesUnderthePhysicianFeeSchedule andOtherRevisionstoPartBforCY2019;MedicareSharedSavingsProgram Requirements;QualityPaymentProgram;andMedicaidPromotingInteroperability Program 
DearMr. Chan, 
On behalf of LegacyHeartCare,LLC (Legacy), I write to respectfully request immediate action to revise HCPCS code G0166 that was inappropriatelyrevalued in the CY 2019 Physician Fee Schedule (PFS) Final Rule. Ifleft unaddressed, this actionwill significantly impedeLegacy’s abilitytocontinueprovidingthis life-enhancing treatment toourpatients. We appreciate the opportunity to bring this matter to your attention. 
Legacyis thenation’s leadinghealthcareproviderfor the non-invasivecardiovascular therapy External Counterpulsation (ECP; HCPCSCodeG0166), delivering an estimated 25% ofthenational utilization forthis service.  Per thePurpose Statement to our organization, wefirmlybelievein makinga positiveimpact on everylifewe touch and havebeen achieving this objective for the past 15 years.  We have a unique expertise on this particular service andproudlypartnerwith over1,000 cardiologists(many members of American CollegeofCardiology) in thecommunities we serve to deliver exemplary health care to Medicarebeneficiaries. 
In opening, I would like to point out the reason of the timing of this correspondence. The Federal Registerforthe PFSProposed Rule (83 FR 35704)1did notcorrespond withthe changes made in the fee schedule formula, more specifically the PE RVU inputs.  In reviewing the Proposed Rule,we hope you will agree with the confusion when reconciling 
the facts listed in this document compared to the actual changes to Code G0166. 
Thereare4items Iwould liketo pointto in this document: 
1. 
Proposed Valuation of Specific Codes: (62)ExternalCounterpulsation(HCPCSCODE G0166) 83 FR 35772 

2. 
Table13 –CY2019Proposed WorkRVUs forNew,Revised,and PotentiallyMisvalued Codes 83 FR 35786 

3. 
Table14 –CY2019Proposed DirectPE Refinements 83 FR 35787 

4. 
Table 17 – Proposed CY2019 No Direct PE Refinements 83 FR 35832 


In the Proposed Valuation section, the rule text clearly states there is a proposed adjustment to workRVU. In the last sentence,theproposal suggestsPE RVUrefinement to the equipment times in accordance to standard equipment time formulas. This is theonly textual reference to adjustmentofPE RVU inputs. 
In Table 13, G0166 is listed inagreement to the Proposed Valuation section that the work RVU will beadjusted from 0.07 to 0.00.LegacyHeart Care reviewed this suggestion anddid not contest. 
In Table 14, titledProposed Direct PE Refinements, G0166 isnot listed. 
In Table 17, titled No DirectPE Refinements,G0166 is listed. 
Wereviewed this information in July 2018 and elected not to commentbecauseweagreed with the information provided in the ruling.  However,we were certainly caught off guard when discoveringsignificantchangesweremadeto several components of thePE RVU inputs that resulted in a 20% reductionfor G0166. We understand that CMS promotes an environment of transparency andvalues high-qualitycareforitsbeneficiares,so we appreciate the opportunity to clarify facts thatwebelievewill compel the Agencytorevise accordingly the direct PE inputs forthis value-added service. Unfortunately, if G0166 is not adjusted back to CY 2018 rates, we areconcerned that our abilityto continue providing these life-enhancing treatments to Medicarebeneficiarieswhom greatly benefitfrom ourserviceswillbesignificantlyimpeded and force patients to utilize higher cost services, such as emergency services. 
The LegacyHeart Care Approach 
LegacyHeartCaredevelops and manages focusedcardiovascular treatment facilities that specialize inECP.  The LegacyHeartCareclinics are currently the largest provider of ECP services in theUnited States and havebeen nationallyrecognized as theleaderin quality. LegacyHeart Careearned this distinction bycompletelyrethinkingthetreatmentexperiencefrom both a clinical andpatient-centered perspective.  
Thereis recognition that,historically,the modalityoftreatmentmayhavelimited thebroad utilization ofECP. LegacyHeartCareadvocates thatthis bias is not associated with the clinical aspects of the therapy butrather stems fromnon-clinical challenges associated with the deliveryof ECP in traditional settings. Such challengesareasfollows: 
The overwhelming majorityof ECP treatment has been provided via a single unit within the infrastructureof a cardiovasculargroup practiceorhospital setting.  Underthis model, viable patientvolumesarerarelyachieved within thegroup and non-group referrals are the exception. Thereis a strong tendency against referring patients to a competing practicefora 7-week treatment regime. This lack of sustainable volume, along with the compromised patient experience, is a natural deterrent for a single group or hospital tofocuson ECPand forpatients to complete the full course of treatment.  
Forthepast15years,LegacyHeartCare has removed the therapy from its typical confines of a single bed in a single exam-room, designing 8-10 treatment unit facilities that are easily accessible to the broad healthcare communities weserve.  LegacyHeartCareconsciously designed thetreatment experience and operational flow downthe smallest of details, resulting in high levels of patient compliance with and completion of treatment. In fact, while the national completion ratewith thehistorical model averaged 60%, over90%ofpatientsinitiating treatment at Legacy Heart Care will complete their entire seven-weekcourse of therapy. This is asignificantadvancementto thehistorical challengesthistherapy facedin previous single-bed­models that may devote a single technician. 
As an example,with thestandard courseofECPatLegacy'sfacility, acardiovascular nurse practitioner,will bededicatedtothe patient’s7-weekcourse(onehoura day,fivedaysa week). At each visit the patient is weighed, vital signs are taken pre and post treatment, and EKG is continuously monitored throughoutthetreatment.The nursepractitionerauscultates heartand lungsounds,assessesvolumestatus, reviews medication adherence,educates forco­morbiditiesand chronic conditions, discussesnutritionand activitylevels,and actsasa conduit to thepatient'scommunity physiciansif the patient is showing any significant change in status. This focus on education and patientcarehas been proven to reducehospital readmissions. Our workwas published in the American Journal of Cardiologydemonstrating an 82% reduction in 90-dayhospital readmissions(34% to 6%).2Manydo notrecognizethat ECP hasover400 published peerreviewed articlesand 13randomized control trialsprovingits safety and efficacy.[Attachment 3] 
TheLegacyHeartCareclinics haveredefined thedeliverysystem of this technology, developing a dynamic program with ECP at its core.  Data collected on Legacy Heart Care patients – pre­treatment, over the course of treatment, and post-treatment(up to 2 year follow up) –provides a strong evidentiary basisforthe valueofthistherapy.[Attachment 2]Improvements in symptom frequency and severity, enhanced quality of life measures, and a reduction in health care resource utilizationplaceLegacy Heart Care in the center of the Triple Aim initiative. Along withourclinical outcomemeasures,Legacyhasearneda Net Promotor Score (NPS) of 88from our patients. 
Our overridingconcern is that CMS is unaware of the full set offacts that have led to the recent changes inRVU inputs, whichwill result in our program disappearing for all stakeholders –the patientsand CMS. Therefore,werespectfullyrequest that the informationthat was used to makethechanges in LaborCodevalue from 0.51 for a registered nurse to0.37for a technician/limitedpracticenurseblend. As mentioned above, Legacy is viewed as a Center of Excellenceforthesechronicischemicpatients,ourcenterscanoffercare to 25-45 patients per day and service an entire community for this specialized service.  
In our staffing model,we dedicatea Nurse Practitioner to every 4-5 patients per hour (simultaneously being treated, similar to a dialysis center model).  In addition, we have 1 Medical Technician forevery2patientsperhour. Wehavelearned over15yearsofexperience that it is necessaryto dedicate this licensed provider along with the described medical technician ratio,who are supervised by a physician,in orderto deliverappropriate care for these complexpatients. Manyof ourpatientshave4-6 chronic conditionsthat our staff can assist managing through the 35 treatment sessions.  Not only are our Nurse Practitioners essential to coaching patientsto adhere to their treatment programs(90% adherence vs 60%), thisdedicated oversightaddstremendousvaluebyadvancing patient self-managementskills. 
Although we are not requesting an increaseto the RVU labor inputsfrom years past or challenging the work RVU adjustment described in the CY 2019 Final Rule, wecertainlydo not believeitis indicativeorpractical useto reducethelaborcodefrom 0.51 to 0.37.Webelieveit is relevant theCMS decided the LaborCodevalue 0.51 forthepast 15 years. It appears there has not been an appropriate review to conclude of any such change. 
In addition, we would like to contest theaccuracy of the contractor (StrategyGen) CMS utilized for equipment pricing. Please see the attached [Attachment 1]5-year pricing fromVasomedical, whichisthe only manufacturer of ECP equipmentwith proven randomized control trials (RCT) to support meaningful clinical outcomes. StrategyGenhasrecommended a changeinequipment cost from $150,000 to roughly $61,000 over a 4-year phase-in for EQ012 (ECPequipment). This change is exceptionallymisrepresentative and would be detrimental to the ability to offer care to Medicare beneficiariesif it affectedthe PE RVU inputs.It is clear that the contractor most likelydid not haveaccess to complete information, such as, the understanding of the cost of equipment from the only manufacturer the with RCT clinical outcomes, the cost of preventative maintenance,expensiveparts thatdegradewithin oneyear(treatmenthoses,treatmentcuffs, valves, carbon fins on air compressors, air regulators, treatment bladders,and ECG cables). All oftheseelementsare part of the Equipment costs that need to be taken into account. 
Additionally,webelievethePracticeExpense Subcommitteeerred becauseit did nothave certain information to include all the necessary information in regard to the Supply vignette to CMS. Notes state the patient is fully clothed during treatment – this is untrue.  ECP must be performed with a patientin specialized treatmentpants. Thesepantsfitto thelegsto prevent blisteringanddo notimpedethe appropriatecompression thatisthefoundation ofthetherapy. If a patient wore clothing such as pants or shorts, the therapy would be ineffective or dangerous. This is yet another example of RVU inputs being altered without the full set of facts.    
Legacyis devoted to makinga differencethrough valueto Medicarebeneficiaries. We work directlywith patientsthat have multiplechronic conditions and have the ability to deliver care for 35 consecutive days with a 90% completion rate.Wespecializein keepingpatients outof the hospital and continueto generatecompelling data thatsavesthesystem significantresources and drives health to your beneficiaries [Attachment 2]. Therefore,we urgeCMS to fully consider all pertinent factsbeforeassumingthehistorical deliveryofECPistheonlymethod ofsuccess with this technology. Below is a list of some of the leading hospital system’s we partner with to providecareto their patients: 
Baylor Scott&White Texas Health Resources UT Southwestern VeteransAdministration MethodistHealthcareSystem Hospital Corporation of America Adventist Health System St. David’s (HCA) Seton Medical Center(Ascension) Atrium Health Novant Health Banner Health DignityHealth HonorHealth TenetHealthcare Caromont Health Piedmont Medical Center University Health System Baptist Health System 
Specifically, we request that a technical correction—torevisetheequipmentandclinical staff directpracticeexpenseinputsdiscussedabove—beretroactivelyimplementedassoonas possible,hopefully inaquarterlyupdatein2019. TheRUC reviewed this servicefor CY 2019 rulemaking and we do not believe further review by that group will improve the accuracy of the inputs beyond the information provided in this document. 
Given the time-sensitive urgency of this matter, I welcome the opportunity to speak with you directlyto addressany questions and clarify any concerns you may have. I will be reaching out to youshortly to schedule a time for us to meet in personand thank you for your prompt attention to this matter. 
Sincerely, 

Michael Gratch LegacyHeartCarePresident 
cc: Seema Verma,Administrator DemetriosKouzoukas,Principal DeputyAdministratorforMedicareand Director,Centerfor Medicare Elizabeth Richter, Deputy Director, Center for Medicare Carol Blackford,Director,Hospital and AmbulatoryPolicyGroup,CenterforMedicare Ing-Jye Cheng, Deputy Director, Hospital and Ambulatory Policy Group, Center for Medicare Edith Hambrick,Hospital and AmbulatoryPolicyGroup,CenterforMedicare 
ATTACHMENTS 
1. 
VasomedicalProgramCost Analysis 

2. 
LHCOutcomes 

3. 
BibliographyofPubMedindexedarticlesonexternalcounterpulsation(ECP)orEECP 


REFERENCES 
1. 
OfficeoftheFederalRegister.MedicareProgram;RevisionstoPayment PoliciesUnderthe PhysicianFeeScheduleandOtherRevisionstoPart BforCY2019;MedicareSharedSavings ProgramRequirements;QualityPayment Program;andMedicaidPromotingInteroperability Program.Availablefrom:https://www.federalregister.gov/d/2018-14985/ [Accessed06 February2019] 

2. 
TecsonKM,SilverMA,BruneSDet al.Impact ofEnhancedExternalCounterpulsationonHeart FailureRehospitalizationinPatientsWithIschemicCardiomyopathy.AmJCardiol.2016Mar 15;117(6):901-5. 



Estimated Cost Analysis for EECPSystem,AccessoriesandServices
This5-yearestimated cost analysisforEECPsystem,accessoriesandservices isbasedon4patientsperday,5days aweek@260working days peryear
1,040 = Treatment Hours for 1 Year for 1 Lumenair30 = Estimated Patients Per Year = (1,040 standard hours / 35 treatment hours per patient)
Year 1  Year 2  Year 3  Year 4  Year 5  Total 
Quantity  Cost  Quantity  Cost  Quantity  Cost  Quantity  Cost  Quantity  Cost  Quantity  Cost  
Lumenair EECP System  $19,000.00  $19,000.00  $19,000.00  $19,000.00  $19,000.00  $95,000.00  
Cuff Sets  9  $1,980.00  2  $440.00  6  $1,320.00  6  $1,320.00  6  $1,320.00  29  $6,380.00  
Connectors  54  $243.00  0  $0.00  0  $0.00  6  $27.00  6  $27.00  66  $297.00  
Bladder Sets  9  $585.00  2  $130.00  6  $390.00  6  $390.00  6  $390.00  29  $1,885.00  
Treatment Pants  29  $507.50  33  $577.50  33  $577.50  33  $577.50  33  $577.50  161  $2,817.50  
ECG Paper  2  $22.00  4  $44.00  4  $44.00  4  $44.00  4  $44.00  18  $198.00  
Nu Prep Gel, 4 oz (3 pak)  2  $72.00  1  $36.00  1  $36.00  2  $72.00  1  $36.00  7  $252.00  
3 Lead ECG Cable  0  $0.00  1  $140.00  1  $140.00  1  $140.00  1  $140.00  4  $560.00  
Electrodes (600 per case)  5  $910.00  5  $910.00  5  $910.00  5  $910.00  5  $910.00  25  $4,550.00  
Hoses  0  $0.00  0  $0.00  1  $360.00  1  $360.00  1  $360.00  3  $1,080.00  
Spo2 Probe  0  $0.00  0  $0.00  1  $252.00  0  $0.00  1  $252.00  2  $504.00  
Patient Stop Cable  0  $0.00  0  $0.00  0  $0.00  1  $300.00  0  $0.00  1  $300.00  
Service / Maintenance  0  $0.00  1  $8,995.00  1  $8,995.00  1  $8,995.00  1  $8,995.00  4  $35,980.00  
Clinical Training  0  $0.00  0  $0.00  1  $4,500.00  0  $0.00  1  $4,500.00  2  $9,000.00  
TOTAL  $23,319.50  $30,272.50  $36,524.50  $32,135.50  $36,551.50  $158,803.50  

Cost per patient $777.32  $1,009.08  $1,217.48  $1,071.18  $1,218.38  $1,058.69 

Total estimated cost for Vasomedical related products and services for a 5-year EECP Program. $158,803.50 Average cost per patient per year $1,058.69This estimate does not take into account other costs associated with administering an EECP program, such as space, staff , marketing, supplies other incidentals. 
DISCLAIMER:This analysis is providedonly as a generalestimate. Resultsdepend on many factors. Vasomedicaldoesnot make any representation as to itsaccuracy or applicability toone's particular circumstances.
This analysis is not an offer,representation or warranty by Vasomedical.Thespecificvaluesshown in these calculationsmaynot be the valuesof any offersmadeby Vasomedicalat any time. Any product or service purchase d from Vasomedicalwillbegoverned exclusively by the terms of the specificwrittenagreement based on that productor service. 
Attachment 1 

EECP®THERAPY CONSUMABLES/ACCESSORIES ORDER FORM FacilityName:______________________________ Customer IDNo.:____________________PurchaseOrder No.:_______________ Address:_________________________________________ City:_________________ State:____________ Zip:_________________ ShiptoAttn:___________________ Phone: _____________________Fax: _____________________ EMail: ____________________ 
ShippingMethod(Selectone): NextDay AM NextDay 2nd Day 3rdDay Ground (Customerisresponsibleforallshippingcharges) 
PlaceOrdersviafax:(516)997-6971or EMail:eohara@vasomedical.com 
QTY  P/N  DESCRIPTION  PRICE  
V93-0003  Z-FoldECGPaper, 147 ft. (ModelsTS3,andTS4 andLumenair™)  $11.00  
2-128  RollECGPaper, 240 ft. (ModelMC2)  $8.00  
V93-0025-1  Nu PrepGel,4oz (3Pk)  $36.00  
V93-0026  SignaElectrode Gel,8oz  $8.50  
V93-0026-1  SignaElectrode Gel,2oz  $4.75  
A12-0033  3 LeadIntegrated ECG Cable (AngioNew®V&VI)  $450.00  
V10-0017  3 LeadIntegrated ECG Cable(Models MC2,TS4andLumenair™)  $140.00  
V10-0021  3 LeadIntegrated ECG Cable(Model TS3–includesadapter)  $175.00  
V83-0066  ECG Cable Adaptor (Model TS3 – for use withV10-0017)  $65.00  
V93-0020  Electrodes (600 per case)  $182.00  
V23-0005  Cuff Set,X-Small  $220.00  
V23-0004  Cuff Set,Small  $220.00  
V23-0003  Cuff Set,Medium  $220.00  
V23-0002  Cuff Set,Large  $220.00  
V23-0001  Cuff Set,X-Large  $220.00  
V23-0077  Cuff Set,XX-Large  $220.00  
V10-0022-1  ThighCuff,X-Small  $170.00  
V10-0022-2  ThighCuff,Small  $170.00  
V10-0022-3  ThighCuff,Medium  $170.00  
V10-0022-4  ThighCuff,Large  $170.00  
V10-0022-5  ThighCuff,X-Large  $170.00  
V10-0022-6  ThighCuff,XX-Large  $170.00  
V10-0023-1  CalfCuff,X-Small  $75.00  
V10-0023-2  CalfCuff,Small,Medium &Large  $75.00  
V10-0023-5  CalfCuff,X-Large  $75.00  
V10-0023-6  CalfCuff,XX-Large  $75.00  
V23-0013  Bladder Set,X-Small  $65.00  
V23-0012  Bladder Set,Small  $65.00  
V23-0011  Bladder Set,Medium  $65.00  
V23-0010  Bladder Set,Large  $65.00  
V23-0000  Bladder Set,X-Large(shouldbeused withXLandXXL cuffs)  $65.00  

QTY  P/N  DESCRIPTION  PRICE  
V23-0022-1  TreatmentPants,X-Small  $17.50  
V23-0022-2  TreatmentPants,Small  $17.50  
V23-0022-3  TreatmentPants,Medium  $17.50  
V23-0022-4  TreatmentPants,Large  $17.50  
V23-0022-5  TreatmentPants,X-Large  $17.50  
V23-0022-6  TreatmentPants,XX-Large  $17.50  
V10-0011  Finger Plethysmograph(Models TS3 and TS4)  $325.00  
V83-0006  Finger Plethysmograph(ModelMC2, AngioNew®V&VI)  $168.00  
V23-0007  AbdominalExtension Strap  $20.00  
V23-0006  Ankle Strap  $30.00  
V31-0267  TwiLok™ CuffSideHoseConnector  $4.50  
V53-0084  TwiLok™ SystemAdapterfor Hose (insertedintosystemtable)  $2.25  
V23-0075-0  Hose, Setof6(Lumenair™)  $360.00  
V23-0078-0  Hose, Setof6(Models MC2, TS3, TS4)  $360.00  
V53-0087-0  Hose, Single, (Models MC2, TS3, TS4and Lumenairfor LowerThighAndCalf)  $65.00  
V53-0086-0  Hose, Single,UpperThigh(Lumenair™)  $65.00  
A12-0047  Hose,CompleteSet,Calf,UpperThigh& LowerThigh(AngioNew®V)  $1,125.00  
A12-0045-0  HoseSingle, (250mm) (AngioNew®VI)  $72.00  
A12-0044-0  HoseSingle, (300mm)(AngioNew® VI)  $72.00  
A12-0046-0  Hose,Setof6 (AngioNew®VI)  $550.00  
V83-0253  Spo2Probe(Lumenair™ andModelTS4)  $252.00  
A12-0035  Spo2Probe(Older AngioNew®VandVI)  $380.00  
A12-0037  Spo2Probe(Newer AngioNew®VandVI)  $380.00  
V10-0012  PatientStopCable(ModelTS3)  $300.00  
V10-0014  PatientStopCable(ModelTS4and Lumenair™)  $300.00  
A12-0036  PatientStopCable(AngioNew®VandVI)  $200.00  
AdditionalNotes:  

*Pricessubjecttochange.EECPis aregisteredtrademarkofVasomedical,Inc.All rightsreserved. SER/0100-10Rev.8(Effective2/29/2016) 
Attachment 2 







Attachment 3 
External Counterpulsation /EECP 
PUBMED INDEXED CITATIONS(N=421) [February 08, 2019] 
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2: Wu E, Broström A, Mårtensson J. Experiences of Undergoing Enhanced External Counterpulsation in Patients With Refractory Angina Pectoris: A Qualitative Study. J Cardiovasc Nurs. 2018 Sep 28. doi: 10.1097/JCN.0000000000000530. [Epub ahead of print] PubMed PMID: 30273260. 
3: Abdelwahab AA, Elsaied AM. Can enhanced external counter pulsation as a non-invasive modality be useful in patientswith ischemic cardiomyopathy after coronary artery bypass grafting? Egypt Heart J. 2018 Jun;70(2):119-123. doi: 10.1016/j.ehj.2018.01.002. Epub 2018 Feb 1. PubMed PMID: 30166893; PubMed Central PMCID: PMC6112334. 
4: Sardari A, Hosseini SK, Bozorgi A, Lotfi-Tokaldany M, Sadeghian H, Nejatian M. Effects of Enhanced External Counterpulsation on Heart Rate Recovery in Patients with Coronary Artery Disease. J Tehran Heart Cent. 2018 Jan;13(1):13-17. PubMed PMID: 29997665; PubMed Central PMCID:PMC6037627. 
5: Valenzuela PL, Montalvo Z, Torrontegi E, Sánchez-Martínez G, Lucia A, de la Villa P. Enhanced External Counterpulsation and Recovery From a Plyometric Exercise Bout. Clin J Sport Med. 2018 Jun 26. doi: 10.1097/JSM.0000000000000620. [Epub ahead of print] PubMed PMID: 29952839. 
6: Buschmann EE, Hillmeister P, Bondke Persson A, Liebeskind DS, Schlich L, Kamenzky R, Busjahn A, Buschmann IR, Bramlage P, Hetzel A, Reinhard M. Short-term external counterpulsation augments cerebral blood flow and tissue oxygenation in chronic cerebrovascular occlusive disease. Eur J Neurol. 2018 Nov;25(11):1326-1332. doi:10.1111/ene.13725. Epub 2018 Aug 3. PubMed PMID: 29924461; PubMed Central PMCID: PMC6221180. 
7: Liu JY, Xiong L, Stinear CM, Leung H, Leung TW,Wong KSL. External counterpulsation enhances neuroplasticity to promote stroke recovery. J Neurol Neurosurg Psychiatry. 2018 May 29. pii: jnnp-2018-318185. doi: 10.1136/jnnp-2018-318185. [Epub ahead of print] PubMed PMID: 29844246. 
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cardiovascular and cerebrovascular disease. Med Biol Eng Comput. 2018 Nov;56(11):1959-1971. doi: 10.1007/s11517-018-1834-z.Epub 2018 May 1. PubMed PMID: 29713856. 
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10: Valenzuela PL, Sánchez-Martínez G, Torrontegi E, Montalvo Z, Lucia A, de la Villa P. Enhanced External Counterpulsation and Short-Term Recovery From High-Intensity Interval Training. Int J Sports Physiol Perform. 2018 Sep 1;13(8):1100-1106. doi: 10.1123/ijspp.2017-0792. Epub 2018 Sep 17. PubMed PMID: 29466090. 
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12: Picard F, Panagiotidou P, Wolf-Pütz A, Buschmann I, Buschmann E, Steffen M, Klein RM. Usefulness of Individual Shear Rate Therapy, New Treatment Option for Patients With Symptomatic Coronary Artery Disease. Am J Cardiol. 2018 Feb 15;121(4):416-422. doi: 10.1016/j.amjcard.2017.11.004. Epub 2017 Nov 24. PubMed PMID: 29274808. 
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14: Lapanashvili LV, Alshibaya MD, Veselova J, Bockeria LA. Acute Beneficial Effects of Muscular Counterpulsation in Patients with Coronary Heart Diseases. Int J Angiol. 2017 Sep;26(3):148-157. doi: 10.1055/s-0036-1593825. Epub 2016 Nov 
28. PubMed PMID: 28804232; PubMed Central PMCID: PMC5552896. 
15: Xiong L, Tian G, Wang L, Lin W, Chen X, Leung TWH, Soo YOY, Wong LKS. External Counterpulsation Increases Beat-to-Beat Heart Rate Variability in Patients with Ischemic Stroke. J Stroke Cerebrovasc Dis. 2017 Jul;26(7):1487-1492. doi: 10.1016/j.jstrokecerebrovasdis.2017.03.007. Epub 2017 Apr 7. PubMed PMID: 28396189. 
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PMID: 27891374; PubMed Central PMCID: PMC5121712. 
18: Melin M, Montelius A, Rydén L, Gonon A, Hagerman I, Rullman E. Effects of enhanced external counterpulsation on skeletal muscle gene expression in patients with severe heart failure. Clin Physiol Funct Imaging. 2018 Jan;38(1):118-127. doi: 10.1111/cpf.12392. Epub 2016 Oct 26. PubMed PMID: 27782354. 
19: Zietzer A, Buschmann EE, Janke D, Li L, Brix M, Meyborg H, Stawowy P, Jungk C, Buschmann I, Hillmeister P. Acute physical exercise and long-term individual shear rate therapy increase telomerase activity in human peripheral blood mononuclear cells. Acta Physiol (Oxf). 2017 Jun;220(2):251-262. doi: 10.1111/apha.12820. Epub 2016 Nov 22. PubMed PMID: 27770498. 
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Reference2 
Impact of Enhanced External Counterpulsation on Heart Failure Rehospitalization in Patients With Ischemic Cardiomyopathy 

Kristen M. Tecson, PhDa, Marc A. Silver, MDb, Sonja D. Brune, CNSc, Clay Cauthen, MDd, Michael D. Kwan, MDe, Jeffrey M. Schussler, MDf, Anupama Vasudevan, PhDa, James A. Watts, MDg, and Peter A. McCullough, MD, MPHa,f,h,i,* 
Heart failure (HF) affects millions of Americans and causes .nancial burdens because of the need for rehospitalization. For this reason, health care systems and patients alike are seeking methods to decrease readmissions. We assessed the potential for reducing read­missions of patients with postacute care HF through an educational program combined with enhanced external counterpulsation (EECP). We examined 99 patients with HF who were referred to EECP centers and received heart failure education and EECP treatment within 90 days of hospital discharge from March 2013 to January 2015. We compared observed and predicted 90-day readmission rates and examined results of 6-minute walk tests, Duke Activity Status Index, New York Heart Association classi.cation, and Cana­dian Cardiovascular Society classi.cation before and after EECP. Patients were treated with EECP at a median augmentation pressure of 280 mm Hg (quartile 1 [ 240, quartile 3 [ 280), achieved as early as the .rst treatment. Augmentation ratios varied from 0.4 to 1.9, with a median of 1.0 (quartile 1 [ 0.8, quartile 3 [ 1.2). Only 6 patients (6.1%) had unplanned readmissions compared to the predicted 34%, p <0.0001. The average increase in distance walked was 52 m (18.4%), and the median increase in Duke Activity Status Index was 9.95 points (100%), p values <0.0001. New York Heart Association and Cana­dian Cardiovascular Society classes improved in 61% and 60% of the patients, respectively. In conclusion, patients with HF who received education and EECP within 90 days of discharge had signi.cantly lower readmission rates than predicted, and improved func­tional status, walk distance, and symptoms. 2016 Elsevier Inc. All rights reserved. (Am J Cardiol 2016;117:901e905) 
In March 1995, the US Food and Drug Administration granted 510(k) clearance to market enhanced external counterpulsation (EECP) for the treatment of angina pec­toris, acute myocardial infarction, and cardiogenic shock. Clinical indications expanded in 2002 to include heart failure (HF). An EECP characteristic of particular relevance to the population with HF is the systolic unloading of the left ventricle during de.ation, resulting in reduced afterload and improved ejection fraction. HF affects roughly 5.7 
aBaylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, Texas; bDepartment of Medicine, Advocate Christ Medical Center, Oak Lawn, Illinois; cUT Medicine Cardiology, UT Medicine, San Antonio, Texas; dDell Medical School, Seton Heart Institute, Austin, Texas; eAd­vanced Heart Failure and Cardiac Transplant Program, MHS Health, San Antonio, Texas; fDivision of Cardiology, Baylor University Medical Cen­ter, Dallas, Texas; gCardiology Division, Brooke Army Medical Center, San Antonio, Texas; hDivision of Cardiology, Baylor Jack and Jane Hamilton Heart and Vascular Hospital, Dallas, Texas; and iDivision of Cardiology, The Heart Hospital Baylor Plano, Plano, Texas. Manuscript received November 30, 2015; revised manuscript received and accepted December 17, 2015. 
Funding: This work was funded by the Baylor Foundation and Legacy (Trinity) Heart Care. 
See page 905 for disclosure information. 
*Corresponding author: Tel: (248) 444-6905; fax: (214) 820-7393. 
E-mail address: peteramccullough@gmail.com (P.A. McCullough). 
0002-9149/16/$ -see front matter 2016 Elsevier Inc. All rights reserved. 
http://dx.doi.org/10.1016/j.amjcard.2015.12.024 
million Americans, causes over 1,000,000 hospitalizations each year, and was estimated to cost 32.4 billion dollars in 2015, with millions of dollars attributed to 30-day read­mission penalties.1e3 Thus, health care systems and patients alike are seeking innovative methods to decrease read­missions. In 2007, Soran et al.4 observed an 83% post-treatment reduction of hospitalization for ischemic patients with low ejection fraction. In other studies, EECP improved quality of life, increased exercise tolerance and peak volume of oxygen consumption, and improved New York Heart Association (NYHA) classi.cation.5e8 As attention centers on HF readmission as a target of clinical effectiveness, the role of tailored EECP programs coupled with education regarding medication and diet is worthy of examination and is the purpose of this report.9 
Methods 
Legacy (Trinity) Heart Care provided EECP treatment using Vasomedical Inc. equipment at standalone facilities in multiple US metropolitan areas to patients referred from hospitals and practitioners for EECP therapy. After receiving patients’ informed consent and institutional review board’s approval, the program tracked patients with HF due to ischemic cardiomyopathy who were referred for treatment after hospitalization from 65 physicians. These patients were 
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