pica eee chores United States Senate rangi eini—rah r CConmaITTEE ON THE JUDICIARY WASHINGTON, 6 2510-671 VIA ELECTRON] Morton Schapiro Richard J. Gannotta President President Northwestern University Northwestern Memorial Hospital 633 Clark Street 251 East Huron Street Evanston, IL 60208 Chicago, IL 60611 Dear Mr. Schapiro and Mr. Gannotta: On December 8, 2008, and September 30, 2009, I wrote to you about troubling allegations that the Myxo-ETlogix 5100 Ring (Myxo Ring), an annuloplasty ring used in heart valve repair, had not been cleared for marketing by the Food and Drug ‘Administration (FDA) before it was implanted in patients as part of an outcomes study. In April 2009, the device was cleared with a new name, dETlogix Annuloplasty Ring. Since we last corresponded, several inadequacies in the responses I received from the Northwestern entities® have been brought to my attention. First, it appears that Dr. Patrick McCarthy made contradictory statements regarding the similarity of the Myxo Ring to preexisting devices. Second, it is not clear whether patients received sufficient notice of the safety questions that arose regarding the Mxyo Ring implanted at Northwestern Memorial Hospital (NMH). Most alarmingly, however, I recently received a report from Dr. Nalini Rajamannan —a former professor and physician at Northwestern University’s Feinberg School of Medicine and co-author of the protocol for the study — alleging that a series of documents that fall squarely within the scope of my December 8, 2008 letter was withheld by the University, without any notice that the documents were being withheld. Specifically, the withheld documents pertain to IRB Project Number 1532-004 and consist of the following: (a) A Protocol Application signed by Dr. Patrick McCarthy; (2) An Echo Protocol entitled, “Mitral Valve Pathology: A Quantitative Assessment Pre- and Post- Repair,” authored by Dr. McCarthy; + «arly and Late Outcomes Following Surgical Intervention for Atrial Fibrillation Database.” ? Northwestern University (University); Northwestern Memorial Hospital (NMH); and Northwestern Memorial Faculty Foundation (NMFF).Mr. Schapiro and Mr. Gannotta March 4, 2014 Page 2 of 3 (3) A Waiver of Consent Form signed by Dr. McCarthy (4) A cover letter dated June 29, 2006 and addressed to Dr. McCarthy from Eileen Yates of the University's IRB, which approved IRB Project Number 1532-004 for the period 6/29/2006-6/27/2007 under submission accession number 200606-0680; and (5) A HIPAA Waiver of Authorization Form attached to a cover letter dated June 29, 2006 and addressed to Dr. McCarthy from Eileen Yates of the University's IRB. Moreover, itis alleged that each of these documents were either signed or submitted by Dr. McCarthy in June 2006. If these allegations are true, each of these documents should have been produced in response to Question 2 of my December 8, 2008 letter, which requested: Please provide a copy of all internal communications and correspondence regarding the Myxo Ring and the use of the device as part of an outcomes study. ‘This request covers the period of January 2006 through the date of this letter. As part of its January 5, 2009 response, the University produced a number of documents pertaining to IRB Project Number 1532-003 which were held out as responsive ~ including a New Project Submission Form (NPSF),° a Waiver of Consent Form,? and a HIPPA. Waiver of Authorization Form,® If other responsive documents were to be withheld, then notice and an explanation of the reasons for withholding them should have been provided. ‘To address this inadequacy in your previous document productions, please respond to the following requests for information: (a) Please provide a copy of the following documents pertaining to IRB Project, Number 1532-004: a. A Protocol Application signed by Dr. Patrick McCarthy; b, An Echo Protocol entitled, “Mitral Valve Pathology: A Quantitative Assessment Pre- and Post- Repair,” authored by Dr. McCarthy; ¢. A Waiver of Consent Form signed by Dr. McCarthy; d. A cover letter dated June 29, 2006 and addressed to Dr. MeCarthy from Eileen Yates of the University's IRB, which approved IRB Project Number 1532-004 for the period 6/29/2006-6/27/2007 under submission accession number 200606-0680; and NWU 00058. = NWU 00060. 8 NWU 00061 ~ NWU 00065.Mr. Schapiro and Mr. Gannotta March 4, 2014 Page’3 of 3 e, AHIPAA Waiver of Authorization Form attached to a cover letter dated June 29, 2006 and addressed to Dr. McCarthy from University’s IRB. een Yates of the (2) Please provide a copy of any other documentation, form, report, email, or memorandum regarding IRB Project Number 1532-004, including a New Project, Submission Form, that is in the possession of the University, NMH, or NMFR. ‘This request covers the period of January 2005 through the date of this letter. ‘Thank you for your cooperation in this matter. I would appreciate a response by March 14, 2014. Should you have any questions, please contact Jay Lim of my Committee staff at (202) 224-5225, Sincerely, Charles E. Grassley Ranking Member Committee on the Judiciarytee forthe Piteehon — Nothwestn Una é Stoceorvsubjectn” —— 750Hat Late Shore Biv Soo 700 3 rag, ms tt NORTHWESTERN grote = Pan st 503085 June 29, 2006 Pairick MoCarthy, M.D, Cardiae Surgery 201 F. Huron Streot Galter 10-105) Chicago Campus ARB Project Number: 1532-004 Review Date: 62772006 Approval Period: 6129/2006 - 62772007 Study Sites: ‘Northwestern University, Northwestern Memorial Hospital, Northwestern Medical ‘Faculty Foundation Project'Title: Mitral Valve Pathology: A Quantitative Assessonent Pre- and Post-Repar 20606-0680 Proj ulynission(a) Consider ‘Submission Accession Number ED Pe (On a member ofthe Intiutional Review Board considered and approved your submission reference! above for & gue yeo period ending 62772007. IRB approval includes approval ofthe protocol, HIPAA Compliance and waiver ‘of writen and verbal consent “Veision Date: 06/08/2006 | Waiver of Consent Version Date: 06/07/2006. Protocol IRB approval is granted withthe undorstanding that dhe investigator will: one hangs neither the procedures nor the eansent form without prior IRB review and approval of hose changes Propesed changes most be submited via the IB Rovisions Submission Form found on the OPRS website, 4 Report any cerious adverse events (SAEs) involving an NU subject to tho IRB within S days Report any tmantiipaed problems involving risks fo subjects or adverse events (AES) (the IRB within 30 days, ‘Submit periodic review (PR) to the IRB 6 weeks prior to the expiration of this approval. If renewal is not obtained by the expiration date inleated above, the project will be closed, Senda copy ofthe Final approved consent form and a copy of this approval letter othe Office of Sponsored Research (OSR) itthis sa sponsored projec, Addiinally, OSK nmust be contacted if any mmendinent re made to this projet that may affect the award. «Tor research involving Jesse Brown Veteran's Affairs Medical Center (SBVAMC): Researeb nay not be {nitated at 3B until after IBVAMC Research end Development (R&D) Committee approval, Use only IRB- approved and stamped VA consent documents. EXHIBIT lea ‘NMC Forme formation eprding ORS submsion nd gui, please const hip ow northwest ofeseare VOPR ‘Tus huduaton stn epposedPederatwide Asrancs with th Deparment of Heath and Human Seems; Aszrene IDY FWAQQ0015#9, NMH 000005ttn fordho Protection Notes Lowest Gifseeaeh sects” TSOW Lae Shove On ‘ute 700 hago 6614 N@eotwesteme Ino Sisto June 29, 2006 Pattie MeCarthy, M.D. Cardio Surgery 201 B. Huron Street Galter 10-105 IRB Project Number: 1592-006 Project Title: Mitral Valve Pathology: A Quantitative Assessinent Pre- and Fost-Repair Review Procedure: Expedited ‘Mtachments; Waiver of Authorization Form ear Dr. MeCatthy: “The Institutional Review Boord, in compliance with section 45 CFR 164 512 (i) 2) of the HIPAA Privacy’ Rule and with Northwostern University's HIPAA Research Policy has reviewed your request for Waiver of ‘Authorization form dated 6/8/2006. ‘Based on the information provided, the IRB determined that: «© These of diselosure of PIU involves no more than a minimal ris to the privacy of individuals, based on, at Teast, the presence of the following elements: a). An adequate plan to protect the identifiers from improper use and disclosure, t) An adequate plan o destroy the identifiers atthe earliest opportunity consistent with conduct ofthe ‘scare, unless there is a health ot research justification for retaining the identifies or such retention is ‘otherwise required by law: and e) Adequate written assurances thal the protested health information will not be reused or disclosed to any ‘ther person or entity, exeopt as required by law, for authotized oversight of the esearch study, or for other research for which the use or disclosure of protested health information Would be permitted by HIPAA. ‘© Thesesearch could not practicably be conducted without the waiver, and ‘The research could not praeticably be conducted without access to and vse of the Protected Health Information; and therefore approved Waiver of Authorization for this research, Please note thatthis is « one-time approval and that you do not need to re-submit the FUPAA response forsn with ‘your periodic review submission, Sino EXHIBIT Bileen Yates, BR, CIP Senior IRB Chat¥jnator ! fe ‘oc mare infomation regrdiog OPRS submissions and guidelines, plese consult pif sorthvestern.cdulesenrcVOPRSIHD, ene arate ea Peteratwide Assurance with he Deparment of Health and Human SercesAssurene ID PWADOOD1 S49, NMH 060006TRB Review -Oiice Use Only | MF Dave Slamp- Office se Ouly | RB Accession Nombor Northwastam University RECEIVED POOIL00W — Oo 3D. Inattulona Rovio card Office Us Only EXPEDITED REVI JUN 2.0 20 Pr he one ypu ON 20 208 OPRS. Northwestern University ~ Office for the Protection of Research Subjects TIRAA Waiver of Authorization Form struction: Consult Northwestern Univorsity"s HJPAA Restatch Polley for additional guidance woven northwest ed researcl/OPRS/inbfbandbook/NU EURAA policy das, Weivers and exceptions (other than de-ienlified mformatjon) are not available if yous research Involves sensitive information ‘uding information related to AYDSI(AIV, mental heath or substance abuse or genetics Forward thts submission OPRS, Rubloff, ® Floor, 250 N. Lake Shore Drive, Chicago, 1 60641 or Hogan, 6100-6" Floor, 2205 Teeh Drive, Evanston, U, 60208 HANDWRITTEN FORMS WILL NOT BE ACCEPTED. Fi. Date of Preparation; 6/06 REVISED 60/06 2. Project Titles Mitral Valve Pathology: A Quantitative Assessment Pre- and Post Repair 5. Investigator Principal Investigator Name: Patrick M. McCarthy Faculty [] Faculty Advisor School/Centor: Medical hepartment/Division: | Surgery! Cardiothoracie Division [Mailing Address: 204 1. Huron |Building/Room H/Campus): Galfer $0105 HTelephone Number; 312-695-3114 Fax Number 5-1903 pager Number: 5-5420 E-Mail Adduess: pmecart@un Submission Preparer: ‘nna Hsin, RN |School/Center: Medicine DepartmenvDivision Cardiology Mailing Addtess: 201 B, Huron (Building/Room #) Galter 11-215 ‘Telephone Number: 312-695.-4067 Fax Number: 5-684 E-Mail Address: [email protected] J Abstract Summanyi (Please use the abstract sumimnry that fe included in the New Projeet Submission Form if applicable) Summarize the proposed research project. Thestnmary shouldbe writen in non fchniea!longuage Mat eon be aeeesiood by nom acne members. The information st Hcl: 1) a brief statement of he problem ane yeleted theory ‘pportng the reason forthe study, 2) abr bu spel deseripion ofthe procedure) volving human subjects (This summary should be 200 words or less [approximately "4 page).) “Mitral regurgitation (MR) i the most commonly encountered valve lesionin modern clinical prctiee, In ft there Nout $00,060 discharge diagnoses of mira valve disease annually inthe United States. MR may be dus to a primary bnormality ofthe valve apparatus or may be secondary to another eardia disease, Patients with chron severe MR. iimy romain asymptomatic for years; however, 28th disease progresses patents may experience dyspnea (shatness of brea, paroxyemel nocturnal dyspnes, and pelptations due to aval Abrilaon,Mivalregurgitstion may eventally result in dilation of the ffi ventricle dilaton and hypertrophy to sega noreasing reguigitant volume, HIPAA Walt of Athrtion Foe 47/2006 ofa NMH 000007jrof the mival valve annulus and | ire and even death, ment oF the tlt alvivm and in (urn causes dl ly load to congestive leat fail Ti ernst volun and ens cversining of Mit IfTef untreated, nie regurgitation can eventual ization willbe used. There ave no study interventions, Medical ‘yet mitral valve repair between April 2004 and Sune 2006, Data 17). Roce, gender, economic class, age, and ‘is isa single-center, rettospective study. No randori lccond reviews will be conducted on patients who under [collected fon this study can be seen in the Protocol Appendix (pages 3 sonal ability wll have no infvence on study inclusion The primary objectives ofthis project are 1) Quantify mite Mave pathology pre-and post-opair by eshocardiographie examination an dretsurgveal analysis, 2) Assess the efcts Persea Rak and Mio Elo ix ings on mitral valve geometry aud reduction in mitt regwigiation, as measured iby 2D/3D echocartiograph [5 Project Fonding S's Projectinatated by C]Sponsor BB tovestigtor other (plan) Js2. Funding Source: PyPedeatState — C}Poundaion _[[]Industy Sponsored [5] Voluntary Heath uganaaon ENorhwestom University Sponsored C}Intnal Sources] Deparment] ia BJ Ove Yenplaia) No funding: projet supported bythe Bum Cardiovsscabar Institute 53. Sponson/Company. Contactor Grant Nomber: ct Name: Cantsce Phone ojeet Site(e (Check all bones Indicating whore he ty conducted) Northwestern University (NU) TL] Rebsbtitation Intute of Chea (RIC) Novthwestem Ceter for Clinial Ressarch (NCR) 1 VA" Lakorde Division (VALMC) Northwestern Mele! Faculty Foundation (NM?) {Z] Evanston Novthwestern Hospital ENH) ‘Norwest Memorial (NM) 1 Chidren's Memorial Hospital (CMA) "Monhwestetn Memorial Nospitst, [E) Edward H. Kaplan Assocaee General Chnkal Rescach Centr (GCRC) 1] Metey Grom Fy Noster Memor! Home Heath Care QIMANCC)[) Midwest Cano Resoach Grown [5 Nortiestem Memoril Physician's Group (MPG) Midwest Conter HematclogyOncology {21 Othe (Specify and Explain) 17, Protected Health Taformation (PHI): IDescribe the entra you wll vse for selecting patil subject records JA patients who underwent mitral valve repair from April 2004 through June 2006 retrospectively. Race, gender, economic elas, age, and mental ability wil have wo rie purpose of accessing these records is (pease check below) [BQ to collect etrospective data for purpose ofthe study a desertbed inthe [5 to recruit: demificaion of potenti! participants [1 other (pease describe): we sludy protocol please check bslow the PUT elements that you intent to ae and (calle or your research Names Ba Names sail sibalisions smal than Stat, intng ste es cli couty, pein ip cals an Net ae eas exept forthe nt) tre dls ofthe ap code according he current pblicy aval dau em rds with the same thee nial digs conaina ‘lureu ofthe census a) the googrephio unit formed by contbining all zp co Encinas dls of mip coe for leach geogrophic uns contaning 20,000 or ‘mote than 20,000 peop! fewer people ls changed to 000, +r dates dretly related to an individual, including bith date, admission date, dscherB® ‘eept that such Bd Alleternnts of dates (except year) fo ‘date, death dale; and ell ages over fags and elements may be sgeregeed i (Telephone nunbers 1B ox numbers Blecteonic mail addresses 5 Social security numbers 1B Medica! record numbers ED Health plen identification nurnbers "HIPAA Waiver of Astro orn 4212006 Tora 19 ond il clerrnts of dates (nciding year) indeatve of such age, into a single calogory of age 90 or oer NMH 000008LT Account nimbers 1) Centteueticense munbors (C} Veiete entfrs nd serial numbers, Devic fetes ad serial numbers ‘Wah Universal Resowes Locators (ORLA) Inert Protocol (IP) addiess numbers Biome Wet, eluding finger and von pits Pall fice potorapic mages ond my comparable inoges fang other unig entfyingenmber, haart codes yes, expan ching license pate numbers [s. Minimal Necessary Stanc IBeveribe how the inforrvation you are collecting (inicaed above in #7) isthe minimally necessary required information to condt your esearch, Collecting information about characteristics of the entire study population, determining outcomes (sue rate, complication rate ef.) and avoidance of record duplication can only be accomplished through access to and u lof the protected health information. [o, Fall Waiver “This section does wot apply C] var Tor Purposes other than Recraliment hrtcase complete this setion only If the purpose of your research study is fo callect retrospective information from a medical Jeharc review, and it your study guslifies fora waiver of consent form: 5.1 The proposed uo of the protected health Information presents no move than minimal rik tothe privacy a individuals bese: Minimal risk has becn defined as the amount of risk that an individual would encounter in their daily life, Using this definition, the study does not invalve any physical risk lo the patient. There are no prescribed Invterventions for this study. Any reports will have information analyzed in aggreyate fo make individwal identification impossible. ly.2. Describe she plan to protect dente o inks to identifiers from imypropet vse and disclosure: ‘or this study protected health inforination will be maintained jx both paper and electronic formats. Access {0 protected healt information maintained in a paper format will be secured in a locked document storage room Phen the information is not in use, Access ¢o protected health intormation maintained in electronic format will pe sceured by Hiniting access tothe information using password proteetion and operating system user permission, J» Data is only available to persons entering data (coordinator) and (o the Investigator/Co- Investigators. Study ata will be stored in a password-protected computer and only the nuthorized study personnel will have access fo the data after itis entered. The coordinator will keep paper copics of the Data Collection Forms (DCF) in Tocked file cabinets, accessible to authorized personnel only, until Inter entry into the computer spreadsheet. No| personally identifying information will ever be presented/published 193 Describe the plan to destroy the wentfer atthe earliest opportunity consistent withthe conduct of research Study documentation, hard copies and electronic willbe retained for a period of five yents fellowing Completion of data analysis and manuseript preparation. At this time the site will delete all eomputer files and all paper records will be shredded. o.4 ‘The research could not practcably be conducted without the waiver of authorization because Js Due to the large number of patients (> 100) undergoing mitral valve repair it would be difficult fo contact all patients a contact information may not be eurrent, and some of the patients nay no longer be alive, 5 ‘The research could not precticably be conducted without acess to and use of protected health information becauce: le ‘This research could not practicably be conducted without access to and use of the protected health iuformation because protected health information (Le, patient name aad DOB) is necessary ( dentify patients who satisfy the patien selection exiteria, Collecting informacion about outcomes (complications, success rate ote) of mitral valve surgery treatment can only be accomplished through access fo and use of protected health information HIPAA Weer af Asrzaan Fo 47212006 3o0f4 NMH 060009“Ihe protected health information (PLT that you plan (o use iu this researc! 10, Whore will you obta 1s Patient Records ofthe felling Institution: please chek the Snorder to eolect the vesearch data, you wil wed vo aces appropiate sites) bolow: 2 Northwestern Univesity (NU) [ Retwbittaion institate of Chicago (RIC) Gy Nouthwestern Centr fot Ciiieal Research (NCCR) Cy VA- Lakeside Division (VALMO) [Bd Nonthwvestern Medical Faculty Foundation (MEF) 1] ivonston Nosthorestezn Hospital END) ) Noxthwestern Memonal (NM) Fy Children's Memorial Hospital (CME) {2 Noxthwestein Memorial Hospital, Babar Kaplan & Associates 5) General Ctinical Research Center (GORC) (Mercy Group [EF] Nonthorestern Memorial Home Heath Core (NMEEICC) [E} Miwest Cancer Research Group [7] Nouthwestern Memoriel Physician's Group (NMPG) EE} Midwest Center for lematology/Oncology Silver Coss i Other (Specify and Explaln) ~ Lis all the entities or individwals who may use oF will have access €0 protected health informatio (iene note: The IRB Boatd Members andthe OPRS staff have acess to al recarch records apart of thelr compliance and quality control oversight responsibilities) {] Pronrpal investigator C) Date Coordinating Centers IF) See tsechOnpiatineOes (Name: ) Bl Governn Sponsors [i Research Data Management Offices (Name Offices: Bluhm CardovaseulneBustitute'sCtintenl Trials Watt) [Other (Specify and Explains) 2 1 Other NU staff working on the project Ey collsboraing Centers (Name Centers. ) Agencies 12, Waiver for Recruitment purposes only: ‘This section docs not apply ‘As of December 13, 2005, waiver for recruitment fs not necessary it you ave receiving patient information from NIMH, NMER and/or RIC for the purpose of contacting these patients fo enrolt then in a research stedy. Iyou are receiving potential subject information from any other healthcare provider, you are required to complete this section. ‘This waiver ts considered a PARTIAL Wales you will need to obtain authorization from subjects who consent (o participate In your study. 12 1 Any PHI used to identify individuals to enrol as study participants will nt be removed form the source's ste ‘lease cheek "Yes" or "No" below If "No", the woiver canot be granted. Dyer No 12.2, Describe the processes uted for selecting subjects and the methods of recruitment? 12.3 Who will review the records to gather information? (Note: this person(s) must bested on the authorl2cd personnel list ofthe JR's NPSF and must be allowed (0 yeview the records under IRD regulations of the Common Rule (the treating physician or a study coordinator who fs also a nurse in the practice are persons who would, under IRB rules, be allowed (o review the records.) [Name of Person doing review ofthe records: “The IRB will require a letter from the relevant phyolan or authorized personnel ofthat physician evidencing their consent to permit the above named individual) to roview ie records, A template eters attached to this application an shouldbe revised to reflect the relevant physician or authorized personnel from whom you seek permission, as well ws the Individuals) ‘who wil be reviewing the records. IRB wil not grant the Wawver for Recruitment without this eter 12.4 The proposed use ofthe protected helth information presets no mare hat nla sk ta the privacy of individuals be 12.5 The research could not practcably be conducted without the waiver of authorization because 12,6 The research could not practcably be conducted without access to end use of protected heath information because: 13. InvestigatordPaculty Advisor Assurance Luvestigator’s Assuranee: "HIPAA Warrerofdleroain For W22006 ora NMH 0000101, Laat all the enlties or individuals who may nse oF will have access 0p |Qlease note: The IRB Board Members andthe OPRS staff have acess to all esate records as part oftheir compliance sd quay contol oversight vesponsibiities ) Principal investigator {5 Other NU sta working an the project Data Coordinating Centers Cy Collaborating Centers (Naine Centers ) {Gouna ex ne 9} €1 Government Agencies Sponsors . [Gl Reseach Data Management Offices (Narne Offices lum CuvdioyaseutarTustitate's Clinical Tats Uni) |] Other (Specify and Explain: 12, Waiver for Reeruitinent purposes only: is nection does not apply 6d ‘Asof December 13, 2005, a waiver for recruitment is notsecessary i'you ave receiving patient information from MLE, NMR and/or RIC for the purpose of covtacting these patients (0 enroll then fn a resenveh study. {Ifyou are jeveiving potential subject information from any other hentthare provider, you are required (0 complete ths section. ‘his waver is considered a PARTIAL Waiver; you wil wed fo obtain authorization from subjects who consent opartsipate in your stay. 121 Any PHI uted fo Wnty individuals to enrol as dy pcipants wil nt be removed fm the source's site ‘lease eheck"Yes" of "No below. IF “No the wove exnnol be granted. (ves One 122 Deserbo te processes used fr selecting subject andthe methods of ecient? 12.3, Who wil evlw the record to gather information? (Mote: tis person) must be iste onthe avnrized personnel st ofthe TR's NPST and ust be alowed fo review the records under IRD regulations ofthe Cominon Rate (ete treating physician ora sy eaortinator who Is also nurse fn the practice ae persons who would, wnder IRB rules, be alowed fo review the records) “Namne of Peron ding renew ofthe ecards: ‘Phe IRB wil requuealetirfrom the relevant physician or authorized personne! ofthat physician evidenemg then consent to perm the above named individual(s (orev the records A template leer 1 attached to this application and should be revised to eflect the relevant physician ov authorized personne! fom whom you seek permission, as well ste individual(s) ‘who wil be reviewing the rseord, RIB wil not unt the Waive: fr Recruitment without this letter 12.4 The propoted vse ofthe protected health information presents no more that minimal isk to ve privaeyof individuals became 12,5 "The resareh could not pracy be conducted withowt the waiver of authorization because: 12.6 The research could wot practicably be conducted without acess to end use of protected health information because: Ta: Tnvestigntor/Faculty Advisor Assurance tavestigntor’s Assurance: + Toertiy that the information provided inthis application is complete nd accurate, and bat wil comply withthe use and (leclosie resttions described above, nformtion about date will not be used or disclosed 10 anyother perton or entity = apres towoify the NU IRB of any material change inthe statements made on thi aplication, I further cert that any and al ‘protected health information obtained in the course of my esearch is that amount which is minimally necessmy to conduct the Fesearch, ie M.ecaniy MD Pre] 612-66 Briel Ivesgalor’ Nee "al veg Sgt Dae Siadent Tavenignor's Nae “Sladen Tnventgators Signature Dae Fooully Advisors Name Faculty Advisors Signature Daw HIPAA Wane Ata Porm 212006 40f4 NMH 000011‘Mita Vsve Pathology: A Quanststve Asessnent ean Post Rept Mitral Valve Pathology: A Quantitative Assessment Pre- and Post-Repair Patrick M. McCarthy, MD; Principal Investigator ‘Thomas G. Gleason, MD; Co-Investigator Edwin C, MeGee, MD, Co-Investigator Nalini Rajamaman, MD; Co-Investigator ‘Vera H, Rigolin, MD; Co-Investigator Supported by: The Bluhm Cardiovascular Institute Pattick M. MeCarthy M.D. Chief, Division of Cardiothoracic Surgery esnommemara) Co-Director, Bluhm Cardiovascular Institute BIT Professor of Surgery, Feinberg School of Medicine ‘Northwestern University _ 201 East Huron bo Galter Pavilion, 10-105 Chicago, YL 60611-2969 [email protected], Mitral Pathology (MeCerthy, PM) ‘Version 1.0 June 7, 2006) _ NMH 000012ul Vale Pathology A Quantitative Assessment Pre- and Post Rope [Maal Pathology (McCarthy, PM) ‘Version 1.0 (une 7, 2006) NMH 000013‘tl Valve Patology A Quantitative Assessment re and Post Rept ‘Table of Contents I. Buckgvound/Rationale ‘A. Mitral Valve Disease, B, Mitral Regurgitation . Myxomatous Mitral Rega D, Ischemic mitral regurgitation 1B, Quantitative Assessment HH, Study Objective: I, Study Design IV, Potential Risks/Confidentiality 8. V. Bthies a _ ete VE. Data Management/Security _ oe -10- VIL Record Keeping. VIM, Data analyses. References. “ie oe -15- -16- -16- oT Appendix: A: Data Collection. oe _ Preoperative Patient characteristics: Mitral Valve Repair Procedure: __ ‘Postoperative Prior to Discharge Follow-up (6 months after operation): Echocardiography Data Collection ‘Mitral Pathology (MeCxrthy, PM) Version 1.0 (Sune 7, 2006) NMH 000014‘Mata VelvePthgy. Que Assessment re: wnd ost Repal ‘A. Mitval Valve Disease ‘Valvular heart disease 1s the fifth most common cardiovascular disordey affecting, millions of people worldwide,” Fortunately, during the last three decades there have been remarkable advances 1n terms of understanding, diagnosing and managung valvular heatt disease, These advances provide pationts the promise of improved quality of life and the potential for a normal Wifespan.”” However, pe a result of these advances the mimber of patients undergoing complex valve repairs has been ‘Grammatically increasing over the past fow years. In fact, estimates show that valvular surgical cases ill incrense by about 14% fiom 2003 to 2008 (from 89,981 to 102,578), most of which will be for repairs of the mitral valve." “The mitral valve (MY) isa complex structure composed of two valve leaflets (anterior and posto), the mitral valve annulus (which forms a ring around the valve leaflets), the papiliary ranseles Cuhich tether the valve leaflets to the left venuiele, preventing them from prolapsing into {he le alrium), and the chosdae tendineae (which connect the valve leaflets to the papillary muscles). The posterior leaflet isthe widest around the annals and divided into three scallops, Pl, Po, and P3. Pi adjacent tothe anteto-Jateral eomnmissure and is closes (o the aorta (anterios). The opposing sections of the anterior leallet ave designated Al, A2 and A3, 56-The two leaflets are Separated athe annulus by the posteromedial and anterolateral commissures, A. dysfunction of any of those components of the mitral valve apparatus can cause mitral xegurgitation. B. Mitral Regurgitation Mitral regurgitation (MR) is the most commonly encountered valve leston mn modem elinieat practice, In fact, thee about 500,000 discharge diagnoses of mitrl valve discase annually in the United States,’ MR may be dive to a primary abnormality of the valve appavatus or may be secondary to another cardiac disease. Causes of primary MR include myxomatous mitral valve (also called degenerative disease, or MV prolapse), inflammatory (i. rheumatic heart disease) infective endocarditis, wauma (i.e, ruptured chordae) and congenital causes. The secondary (functional) causes of MR include ischemic heart disease, left ventricular systolic dysfunction and hypertrophic cardiomyopathy. Patients with chronic severe MR may remain asymptomatic for years because the regurgitant volume load is well tolerated as a result of compensatory ventricular dilatation, However, as the disease progresses patients may exporience dyspnea, orihopnea, paroxysmal noctuinal dyspnea, and palpitations due to atrial fibrllation.* Mitral regurgitation may ‘eventually result in left ventricle dilation and hypertrophy 1 accommodate for the inoreasing regurgitant ‘volue.®"* "This increased Volume leads to enlargement of the Jett atrium and in turn causes dilation ofthe valve annulus and ‘worsening of leaflet coaptation, As the severity of mitral regurgitation increases, the let ventricle (LV) continues to dilate lending to increases in systolic wall sttess and end-systolio volume with left Ventrcle dysfunction, Ifleft untreated, mitral regurgitation can eventually lend to congestive heart failure and even death.” ‘Today, the optimal surgical intervention for mitrl zeguritation is valve repair, Surgical repair of @ valve involves rebuilding the valve apparatus so that functions properly. As compared with valve replacement, successful valve reper esuls in superior hemodynams, lower operative risk, better ‘Mina Pathology (MeCarthy, PM) Version 1.0 Gune 7, 2006) NMH 000015ia Valve Pathology. A Quanitive Assessment Pre an Pos- Repair c complications, better preservation of ventricular Jong-texm survival, lower sisk of thromboerboll fonetion, and eliminates the need for Yong term anticoagalation. |. Myxomatous Mitral Regurgitation “Fhe most common eause of mitral regurgitation in the United States is myxomgtgus (also known ss degenortive "Dopp" or “billowing” vale) degeneration ofthe ital valve" Degeneration of tne MY is caused by a genetic abnormality inthe connective tissue resulting in thickened, clongated vraive leaftel(s) and chordae tendineae and conunonlyinvoSves thickening and dilaton of the vonulus.!2"" The elongation of the leaflets and chordae tendineae prevent the mitral valve leaflets thom fully coapting when closed, causing the fee edge ofthe leaflets to override the plane ofthe dans resulting in a prolapse into the left atsiom; thereby causing mitral regurgitation ‘he gold standard for repair of myxomatous valves is performed via quadiangular reseeton followed by either annulus placation or andlor sliding leaflet technique (Gliding:plasty)."? The ftuadkangoln technique involves removal of section ofthe valve leaflet, most commonly the Astrir Teall, cinching th vemaining tissues together and veinforeing th repair wih pes toplasty ing tiding-pasty procedure reduces tho height of the posterior leaflet which ultimately moves the coaptation line posteyiorly. 1516 Using these techniques, up to 90% of pation aavndeygo repair of myxematous valves"; however, these techniques are very Gine-consuminty qe diffi o perform and require nonerous years of experience fo perfor successfully AS @ Sea itis likely that a significant percentage of these eases are instead addressed vin a valve seplacement. ‘After quadrangular esection myxomatous valve repairs are most often accompanied by ‘pbtotaon ofan nmoloplasty sng, An annuloplasty sing reduces the size ofthe mia) oocs ancl aeenanor improved leaflet coaptation as well as to stabilize vepans dove on the valve leaflets or hop structures. Nevertheless, repair with cuveat ing systems do not adess the spose Stbogy of myxomatous MV (excessive leaflet issue), which may lead to @ serious eomplicaton fnovieas systolic anterior motion (SAM). This increased risk of SAM after repair of myxomelous aaeae hos been shown to be due ( excess tissue o anterior displacement, or both, of the leaflet coaplation point, "™" “The Myxo ETlogix Annuloplasty Ring was specifically developed for patients with myxomistous Jalval valves (© help eliminate the need to perfoum the complex, time-consuming sliding-plasty Macedure, The Myxo ETlogi is the first ring to address designed Co reshape the annulus to ecommodate the larger leaflets (increases AP distance by 39%) of as previously described by Carpentier allows the Aneror ‘door (leaflets) (o fit the frame (annulus), but by reshaping the frame instend of cutting the door.” In addition, the 3-D design is clevated at the P2 segment; thereby, pulling the posterior leaflet away from the sortc outflow tract to reduce the risk of SAM, The design of the sing should result in simplification ofthe complex repair and thus, will rive mote ‘widespread adoption of mitral valve repair Myxo ETlogix Ring Mitral Pathology (MoCarthy, Po) ‘Version 3.0 (Juve 7, 2006) NMH 000016‘Mal Vale Pathology A Quanfate Assesment re on Post Repay Previous findings suggest that preoperative measurements such as height of the anterior and posterior leaflets, septal thickness, lft venricuareontatlity, and distance of the coapation point Dr the leaflets to the septom are useful in predicting those patients at higher risk for developing, SAM?” Jn addition, studies have also show that reducing, excessive leaflet tissue and posterior: Ieaflet height has been shown to reduce SAM following repair of the mitral valve a D. Ischemic mitral regurgitation Ischomie mittal regurgitation (IMR) most often results from coronary heart disease, particularly the setting of a prior MI? IMR results from several anatomic and pathophystological changes cluding 1) let venbicular wall venodeting [wall motion abnormalities, ditstation) 2) papillary thnusele displacement 3) diataion/asortion of mitral annulus, du to fet venticular enlargement, 2526-7) initiating insult in IMR 1s ventricula specifically left ventricular remodeling following ‘myocardial achemia or infaretion. ‘his remodeling changes the shape ofthe Ly, which ultimately Tends to poor leaflet coaptation, paticularly the posterior leaflet during systole.” “rhe outlook fe» the patient with ischemie MR is substantially worse than that for regurgitation from ‘other eanses.22™ A worse prognosis accrues from the fact tha ischemic MR is usually caused by TLV dysfunetion due to myocardial infaretion, Fuathermore, (he mitral valve itself is usually rmnatomieally normal and MIR is secondary allesatons in the geometry ofthe Teft ventricle and fo papillary muscle dysfuneion and/or displacement making repair of the valve move éafficlt °° Surgical yepair of IMR is often accomplished by placement of an undersized ammnvlopfasty ring Nevertheless, using the standavd, symmnotric annuloplasty rings still leaves up to 30% of patients with residual of recurrent mitral segorgitation.”*>"™ "The Carpentier-MeCarthy-Adams IMR Tetlogix Amauloplasty Ring (CMA IMR ring) was specifically devetoped lor patients with ischemic iia regurgitation. [isthe first asyimmelti ring designed ( treat asymmetric annular dilaton, ‘especially in the anterior-posterioy (A-P) direction, which js observed in patients with IMR.” This Srmloplasty ing ean be fled stategically tothe mstal valve to seduce the antero-posterior Mmenuions to improve function and teduet the amount of rogurgitation in persons with IMR The Ssynmpeti 3-D design with redveed mide to medial (P2-P3) curvature anda slight dpa the P2- /P3 segments inereases coaptation of the wtheted P2-P3 segments aR ETHogh ing ‘The optimal treatment of IMR is a matter of controversy and there is still wide variation in practice among cardiovascular surgeons.'”** We aim to investigate the efficacy and safety of CMA IMR ring in surgical treatment of MR. ‘Mitral Pathology (MeCerthy, PM) Version 1.0 lune 7, 2006) NMH 0600017‘Mua Valve Pathology A Quastiative Assessment Pre- an Post Rept E. Quantitative Assessment Fehocurdiogsaphy is routinely wsed to assess the mechanisms of valve dysfunction and evaluate the results of valve repair, Inb aoperative echacardiographic examination audes jn defesinining predictors of SAM such as the location and severity of leaflet prolapse, leaflet mobility, point of Jeafict coaplation ad thickness of interventricular septum. "* Currently, surgeons at NM are directly measuring the height of mitral valve leaflets using specially designed calipers, Yhrongh these dreet measurements it was identified that antetir leaflet height (A2) and width (commissure to-commissure [C-C)) varied extensively in patients with myxomatous mitral valve disease. This information may explain the variability used for setection of ring sizing [e.. tall A2, narrow C- oF he opposite can occur). Quantification of mitral valve pathology pre- ad post-epait by Crhocariopraphie examination and direct surgical analysis eould potentially allow for tailoring of the valve repair techniques, Quantifying the precise eaflet(s) measurements (ic, height of P2,P3, fle) tha result in suecessfil valve repais may allow fora more predictable repair and advance this surgical technique from an ar oa science. Wl, Srupy Osjecrives rp objectives 1. Quantify mitral valve pathology pre- and post-repair by echocardiographic examination and direct surgical analysis. 9, Assess the effects of the CMA IMR and Myxo FeTlogix rings on mitral valve geometry, as measured by 2D/3D echocardiography. Secondary objectives: 1. Evaluate catly results of myxomatous mitral valve repair using the Myxo BTlogix Ammuloplasty Ring in fexms of veduetion in mitval regurgitation. 2, Determine early results of surgical mivzal valve repair with the CMA IMR ring in terms of the redvotion of ischemic mitral regurgitation. 3. Compare ovicomes of mitral valve repair using the Myxo ETlogix Annuloplasty ring and CMA IMR ring © other annuloplasty ring systems. 4, Disseminate research findings through, scientific conferences, peer-reviewed joumals and other publications IL, Srupy DesiGn “This is a single-center, retrospective study. No randomization will be used. Medical xecord reviews, ‘will be conducted on patients who underwent mitral valve repair between April 2004 and June 2006, Rave, gender, economic class, age, and mental ability will have no influence on study inclusion, Data willbe obtained from the Investignton’s and Co-Investigator’s patient records et Northwestern Memorial Hospital (NMH), Northwestern Medical Faculty Foundation (NMEF) and from our patent population in the Society of Thoraci Surgeons (STS) database (note: In accordance wath STS guidelines, as a Participant jn the database we are able to use our individual database-< id information for clinical research purposes”), All available inpatient (NMI) and ‘outpatient (NMFF) reho studies (Dhn-mode, Doppler, stress echo, RT3DE, and TEB) will be reviewed. Beh and linical parameters pre-and post-susgery will be compared. All data gathered during this study is Mitral Pthology (MeCarthy, PM) te ‘esi 1.0 ie 7, 2006) NMH 060018‘ua Wave Pathology: A Quantitative Assessment Pre and Pos Rep normal and customary clinical mformation recorded by treating physicians. Data collected for this study can be scen in Appondis. A. IV. POFENTIAL HUSKS/CONHIDLN TALLEY Minimal rsk has been defined as the amount of risk that an individual would encounter in the Aaily life, Using this definition, thi stody does not involve any physical isk ta the patient ere sree preseibed interventions. All data that ave callested are from pre-existing mestical record ae ans The study does involve the potendal risks ofa bench of confidentiality ofthe wnedical yecord information and associated privaey of the participants. ‘In cases where stay data is published or shared with ther institutions, data wal be de-kentified. Till never includ identiliable information, such as name, social seemty number, address o+ aan net souoed notnber in osder to rants patient's identity In addon, in most eases the dala aT natinelade identifiers other than age, race, Sex, an Alagnoss sinee most reports are only ve comed with descriptive sunimaries and statistical analyses of “grovped” data, (Nota. Patients cot cat be informed of any study results, as data is analyzed and reported in aggregate.) Vv. Bruics [All patients who underwent mital valve separ from Apnl 2004 through June 2006 wil be reviewed ‘tubapectvely, Race, pendet, esonomic class, age, and mental ability will have no mfvence on study inclusion, ‘We are requesting © waiver of werbaliwritten consent and Health Insurance Portability ant ‘Necantbility Act (HIPAA) authorization for this vtrospective analysis based on the following points: +The use or dsclosute of protected heath information involves no more than. sina isk fo the individuals (HIPAA Privacy; Title 45 CRF Past 46) o Minimal rick has been defined as the amount of risk that an individual! would encounter Waibelr daily life, Using this definition, this etrospoctive project doesnot involve any Hak tothe patents; ii areyiew of pre-existing data ony, There are no prescsibed va penticns.All data that are collected are confidential and no patient identifiers wil be transmitted outside the participating institution. co Any reports or publications wil have information analyzed in aggregate to make ey dal identification impossible. No identifying information will ever be presented or published, + Theatteration or waiver will no adversely affect the privacy rights andthe welfare ofthe individuals (Title 45 CER Patt 46) Hii atent identifying infosmation will be protected and will not be released. © Data wll be presented in aerogae and subject identifiers will not be used. 8 Noppersonal identifying information wil ever be presented or published ‘Mitel Pathology (MeCarthy, PM) cob Version 1,0 Gune 7, 2006) NMH 000019Mitt Valve Pathology. A Quetative AsesientPe- and Post Rea All paper records produced or collected in connection with ths projet Ge data alleetion forms, electronic files) will be destroyed 5 years following completion of data nalysis, Paper documents wll be destroyed by shredding and willbe performed in 8 aver that ensures information cannot be reconstructed. Electronie records will be eaved or destroyed in a manner that guarantees thatthe isk of diselosure of inforration is removed. se ‘There are adequate wniten assurances that PHL will not be used or disclosed toa third party xcept as requlted by law, for authorized oversight ofthe project, or for other uses ‘and Gisclosures permitted by the Privacy Rule (WIPAA Privacy Ruse); oo ats to protected health information is Hinited fo only hose individuals who need fo ase acoese to the information to persorm their responsibilities forthe study, ‘ota his tly protected health information willbe maintained in both paper and re tronic formats. Access to protected health information maintained in @ paper format oral be secured in a locked document storage room when the information 1s notin use suse to protected health information maintained in electronic foxinat will be secured ty limiting acess lo the information using password protection and operating system user permission, + Theprojeet could not practicaby be condvted withouta waiver of individual informed consent Due to the large number of patients @ 125) undergoing mitral valve repair af Northwestern Memorial Lospital between Apnl 2006 arid Jone 2006 itis not Practiable to obiin consent a contaet information may longer be current, and some ff the patients may no longer be alive + Theproject could not practcably be conducted without access to and se of the protected health information (HIPAA Privacy Rule); re i olleoting information about outcomes (reduction in MR, complications, veces rae, ie) of mital valve repair can only be aesomplshed though access 0 and use of protected health information. ‘VI. DATA MANAGEMENT/SECURITY Seudy data will be stored by patient’s name and date of bin in a Miorosol Excel spreadsheet for snalyss ona scour, password protected computer. Only the study investignlons ‘and authorized aaee yeh personel will have access to this dat, This data will be housed on 8 network that is Separated fom the iferet through the use ofa fxewall By design, this denies all external access fo Teeddtabase, To ens integrity and confidentiality of the dat, the system will ot run ‘without the: entry ofa valid username and password. Mitval Pathology QveCarthy, PM), Version 1.0 (une 7, 2006) NMH 000020Miz Valve Patolony, A Quanutanve Assessment ic-and Post-epar VIL Recon KceEPIN ‘The paper file for each subject will contain the corresponding Data Colicotion Forms, The pauticipant’s study folder will be adentified by a mumneric 1D (MVROO1, MVRO02) and patient initials and will be kept in the investigators o1 study coordinater’s office in @ locked file cabinet. Access to safe and locked drawers will be granted only to the Investigator aod study coordinator. ‘Study documentation, hard copies and electronic, will be retained for a period of five years following completion of data analysis and manuscrtpt preparation, AUihis tone the site will delete all computer files and all paper records will be shredded, ‘VIII, DATA ANALYSES Descriptive statistics will be used co compare echocardiographic and surgical measurements before ‘and after surgery for valvular regurgitation, Parameitic tests will be employed to assess the significance of echovardiographic changes. Appropriate comparison will be made within and between patients The differences in other echocardiographic measurements between preoperative and postoperative values will be analyzed by panned fest, Mitral Pathology (MeCarthy, PM) aH10- Version 1.0 (ane 7, 2006) NMH 060021Miual ValvePaology A Quantitative Assessment Pre-ad Post Repair Rurerences 1. American Heart Association, 2000 Heart and Stroke Stabstical Update, 2, Jamieson B, Castier PC, otal. Surgical management of valvular heaxt disease 2004, Can J Cardiol. 2004 (Suppl E); 20-72-1208. 3. Bonow RO, Carabello B, De l.eon AC Jr, etal Guidelines for the management of patients with valvular heant disease: executive summary, A repott of the American Colloge of Cardiology/American Veatt Association Task Foree on Practice Guidelines (Committee on ‘Management of Patients with Valvular Heart Disease). Cireulation, 1998;98:1949-84, 4, Pennington DG. The Impact of New ‘Technology on Cardiothoracic Surgical Practice. Am ‘Thorac Surg. 2006;81°10-18. 5, Alexander, R, et al, Ninth edition Hurst’s The Heart, McGraw-Hill 1998; Chapter 64. 6, Gillinoy AM, Cosgrove DM, Blackstone EU, ot al. Durability of mitral valve repair for degenerative disease. J Thorac Cardiovase Surg. 1998; 116:734-743 7. Jones EC, Devereux RB, Roman MI, etal, Prevalence and correlates of mitral regurgitation in ‘2 population-based sample (the Strong Heart Study), Am J Cardiol. 2001;87:298-304, 8. Carabello BA. The pathophysiology of mitral regurgitation, J Heart Valve Dis. 2000; 9:600- 608, 9. Connolly MW, Gelbfish JS, Jacobowitz , et al, Surgical results for mitral regurgitation from coronary artery disease. J Thorac Cardiovase Surg. 1986; 91:379-388 10, Bekberg DL, Gault JH, Bouchard RL, Karliner JS, Ross J Jr, Mechanics of left ventricular contraction in chronic severe mitral regurgitation, Cirewlation, 1973;47:1252-9 e2-Sarano M, Orszulak TA, Schaff HV, Abel MD, Tajik AAJ, Frye RL. Mitral new clinical perspective, Mayo Clin Proc, 1997;72:1034-43. 11, Basi regurgitation 12, Otto, CM, Evaluation and management of chronic mitral regurgitation. N Eng! J Med. 2001; 345:740-746, 13, Pelletin D, Brecker 8, Veyrat C. Degenerative mitral valve disease with emphasis on mitral valve prolapse. Heart, 2002;88;20-28. jon: an overview. Curr Probl Cardiol. 1995; 14, Fenster MS, Feldman MD: Mitral regurgit 20:193. 15, Perier, P. Quadrangular resection for repair of postetior leaflet prolapse. Multimedia Manual of Cardiothoracic Surg. (November 29, 2005). doi:10.1510/mmets.2004.000893, ‘Mitra Pathology (MeCarthy, PM) critics ‘Version 1.0 (une 7, 2006) NMH 9000022Mist Valve Pathology A Quapbhave Assessneat Px nnd Post Repair 16. Deloohe A, Jcbara VA, Relland JY, of al, Valve ropait with Carpentier techniques. ‘The seeond decade. J Thorac Cardiovasc Surg. 1990;99:990-1001 17. Rew! RM, Cohn LHI, Mitral valve reconstrvction for mitral insufficiency. Prog Cardiovasc Dis 1997,39:567-99. 18. Quigley RL. Prevention of systolic anterior motion after repair ofthe severely myxomatous citat valve with an anterior leaflet valvoloplasty. Ann Thorac Surg, 2005;80:179-182. 19, Rubenstein F, Reichart B, Letsou GV. Alternatives in selection of vings for mitral annuloplasty Current Opinion in Cardiology. 20013)6Q)136-139. 20, Caipentier A. Cardiac valve surgery- the “French Corestion”. J Thorae Cardiovase Sur 1983; 86:323-337, 21. Maslow AD, Regan MM, Haening JM, cal: Echooardiographie predictors of left ventricular eeiflow (act obstruction and systolic anterior motion ofthe mitral valve after mitral valve caeatnetion fer myxomatous valve disease. J Am Coll Cardiol. 199%; 34:2096-2104 22, Lee KS, Stewart W), Lever HM, oa, Mechanism of ntflow tract obstruction causing fae! eral valve rept, Anterior displacement of leaflet coaplalion. Cireulation, 1993; 88:1124-29, 23, He, Topmeyer J, Lefebvre XP, e al, Importance of leaflet elongation in emusing systolic anterior motion of the mitral valve. J Heart Valve Dis. 1997, 6:149-159. 24, Lefebvre XP, He 8, Levine RA, Yoganathan AP. Systolic anterior motion of the mital valye in typertrophue cardiomyopathy: ain vitro pulsatile flow study J Heart Valve Dis. 19953 4:422- 38, 95, Hickey MS, Smith LR, Mubibaies LH, Hancell PE Jr, Reves 1G, Hinobara T, Califf RM, Pryor Dp, Renkin JS, Curent prognosis of ischemic mitral egurgitaton. Implications for future management. Circulation. 1988; 78:151-159. 26, Calafiore, AM, Di Mauro, M, Gallina, S, etal, Mitral Valve Surgery for cbronic mitral regurgitation, Ann Thorac Surg, 2004; 77:1989-97. 27, Pilsoufi, F, Salzberg, SP, Adams, DH. Curent management of ischemic mitral regurgitation. ‘Me Sinai J Med 2005; 72(2):105-15. 28. Akins CW, Hilgenberg AD, Buckley MJ, etal. Mitral valve reconstruction versus replacement for degenerative or schemi mitral regurgitation. An Thorac Surg, 1994; $8°668-675; discussion 675-676. 29, Hausmann J, Siniawski H, Hetzer R. Mitral valve reconstruction and replacement for ischemic rail insufficiency: seven years follow up. J Heart Valve Dis, 1999; 8:536-42. ‘Mira Pathology (McCarthy, PM) seTe ‘Vexsion 1.0 (une 7, 2006) NMH 060023720000 HWN . (on0e 1 9m 01 991%, oe (ova ope 09) Alone TEMA PSE TRTUPTRUOTHTTRT STO NISNTAIO TS MARTA wo. “900% ‘LI AEP poaotnay -asequiep jaLoNoU SS atp Jo asodind puv Aroistg] "(SOOZ) "suOdBINg aF9eXOLL,1Oy KIaWOS “GE e-916:821 ‘vO0e Tame osoAo;pans av.ore ¢ “woRslanBox yee ovetayposs YoUOYoTE 10} JAnseoyne soye wore San9¢ ceniar yuanNo99] “8 19°F BUOISIOUIE “YPN AOUITED “A 99D BE yoensqy °LOS °L1 poor “orpavooyogt o0s wy _p-somg orleBoxpreootjoq eanerodownyuy uy -copeusentiny renin orwaqpsy ut doy aAye A enya ataneg pre jryssagong uosmnog, Wostredued “je 19 WUE Helos Kf UI ‘A BuodarovsBuoy “LE verLOLI “et 100% Bung asouoipany svsoyy, 7 storyeouduroo pu [VAfains wsxay-Buo{ Jo vostEdiod :jwoUaDN|Cos ‘pire tonionustiogas angea Jeni ateHOYss] “Te 79 “Y BHDLTET ‘Cr Braqpjog “Ve SSID “9 Te-SeHt 2 ‘Lone Bang: osenoypse:) osouy, p xonenBinox yen orezayost 39) mHourooefor oF ayqaropond ewdax | “Wed ‘AME, “NEL O14] {f AIAN ING OnouHSOD “Se AOYSTET “HA BHO}SOTIEL ‘Nel AUDA LY AOUTED “SE “poor “woneroossy qe9p] UwoLoUY porous pezuoinduoo JeAoN woneyTandox jeniur omutoyasy ul Kjoruood aeycTUE pest yo toneye(ap warToUIKUASe pam MONOURSAD [RIOT ‘Je 19 {A PUIBKaY] “f OULDEIES “Py COLLECT ve “e-t812:1T1 ‘S002 wonminestD “ppOpEauIAG Ue ML APM oN eXBOrPEDOKIA CE oMN-TORT Y ALORENTINBOy PENNY OHHONDS| ‘sIWOXKKD 10g tedoy] BAJA, ENE SnoDtTENNOADA TWO AY AOTIITD “L BIOMS TWMOUNEA "EE ‘Ov-SELT:LON 1€002 No MOALD “KpmIS KydesBoIpreaoYso peUOIBLOLUP south au qear wvoneySinBar jenn eames Tym AxywdoKutoypreo poyep pue oon st ‘wooing smyemdte pen up Jo soauaroytp ojouroog fe 10 “VC_ JOB “y, HONS “FUE “Ze “OBTZL9T Tbe $1661 ‘woUP/Ro!4D “uoRENteAE jequeUATaAK® LE SwoneyxBenBON yenyur orators} Jo was UENO “VET BUEISONO], ‘A HOOUSHID ‘CAK ZINIONS *§ [ww “TC uw -s91:s6'g961 Sang asorompang aosou.y,¢ wore) Smn8o1 penta otuoyos} wy ywoUtooN| ox anes smstan ated angen fons Jo vostiedwoo [wom Y “1e19 ‘SH ADYOHHT “aT Aojouog “SE UO “OE edoasog pan -atg moussossy onnemaend Vy “BojoyHa AKA, FETtial Vale Pathology A Quanttaie Assessment ie and Pos Repir ‘A COLLECTION, Data collection is broken into four periods: Preoperative, Operative (MY Repair), Postoperative prior to discharge, and Fallove-up (i available), The following data wil be obtained for this retrospective study: Preoperative Pationt characteristies: 1) Patient Demographics: a) Age (at time of procedme) b) Gender ©) Height (em) a) Weight (ke) 2) Previous cardiac comorbidities a) Arrhytluna b) Cerebrovascular accident (yes/no) ‘¢)_ Number of coronary arteries with stenosis (50%) 4) Recent Mi (<14 days) (yes or no) ©) Previous oavdiae operations (PCI, CABG, ete ) 1). Family history of coxonany artery discase (yes/no) ) Re-operation (yes/no) 1h) Other significant valvular disease 3) Non-cardiac comorbidity 1) Diabetes b) Hyperlipidemia ©) Hypertension (DBP > 90 montis) 4) Hyperlididemia (yes or n0) ) Smoking i) Cunently smoking (yes/no) ii) Previously smoke (yos/no) Chronic obstructive pulmonary disease (COPD) £) Renal insufficiency (creatinine & 2.0 me/a.) 1) Other 4) Emergent operation (yes or no) 5) Echocardiographie evaluations- Refer to echo data collection Mitel Pathology (MeCarthy, PM) oie ‘Version 1.0 (une 7, 2006) NMH 000025ial Valve Pathology A Quanttaive Assesimeat Pee an Past Rept Mitval Valve Repair Procedure: Pre-Repair: 1) Date of epaie 2) Regurgitation: (Nome; 415425 435 44) 3) Biology: (Myxomatous;Ischemic; Calcific; Rheumatic; Radiation; Cardiomyopathy; Other) 4) Leaflet (posterior): (normal; lai (prolapse); tethering) 5) Leaflet Height (mm): (P1; P25 P3; A2) 8) Lesion: (Posterior, Anterior, bi-teaflet) Intra-Operative Ret 1) Commissure to Commissure (min) 2) Trigone to Trigone (mum) 3) Owiandragular Resection (yes/no) a) Width of Resection (mmm) b) Width of Resection (min) (after annuloplasty) c)_ Width of Resection (imi) (after compression) 4) Sliding Amnoloplasty (yes/no) Post-Revair 1) Valve Procedure 2) Annuloplasty Only b) Reconstruction w Annuloplasty ). Reconstruction wo Annuloplasty Repair w reconstruction i) Chordal ‘Transfer (yes/no) ii) Quadrangular Resection (yes/no) i) Alfieri Repair iv) Plication v) Compression vi) Patch 2) X-Clamp time (bh:mm) 3). CPB time (hmm) 4), Regurgitation: (None; +15 +2, 435 +4) 5) Leaflet Height (mm): (P1; P2; P3; A2; P-middle) 6) Coaptation Depth/ Overlap (anim): (P1; P25 P3; Al; A2; A3) 7) Annuloplasty Ring (oom) 8) Mitral Ring Type: Physio; Bt-Logix; Myxo-logic 9) Inside of Ring to Coaptation Point (mam) 10)Concomitant procedures a) Coronary artery bypass graft (# of vessels) b) Left ventricular reconstruction ©) Maze procedure ¢) Ligation of lef atrial appendectomy 2) Tiicuspid repait {) Patent foramen ovale (PFO) closure ‘Maral Pathology (MeCarthy, PM) ise ‘Version 1.0 Gune 7,2006) NMH 000026Mital Vlve Pathology, A Quamutive Assessinel Pre and Post Repa 2) Aoitic root /valve replacement h) Other 3) Operative complications 8). Atvial Fibrillation (yes or no) b) Archythmia ©) Bleoding. ) Pleural effusion ©) Cardiac arrest ) Congestive heat failure 8) Pericardial effusion h) Death i) Other 6) Transesophageal echocardiography (TEB)- Refer to echo data collection forms Postoperative Prior to Discharge 1) Complications 8) AF (yes or no) b) Amhythmia ©) Bleeding 4) Pleural effusion €) Cardiac arrest 4) Congestive heart failure #) Death h) Other i) NYMA class (1-V) 2, Behocardiography (2-10 days after surgery)- Refer to echo data collection forms Follow-up (6 months after operation Collect, if available 1) Medical history for the follow-up period (e.g, hospitalizations) 2) NYIIA Classification (-V) 3) Echooardiography- Refer to echo data collection forms ‘Mitral Pathology (MeCerthy, PM) 16 Version 1,0 une 7, 2006) NMH 000027Mitel Valve Pathology, A Quonanve Assessment Pre and Post Roa Behocardiography Data Collection Raed Va Rep ehocaraiogeaply Data Collection Danesh Josectcae 7. 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A Quantitae Assessment Pre: snd Post Repair ett esos atonal ote ho etn socom, — ‘ 2 Pek eat Pot waecnkntcn ont can 21 Rouben nom testlooond now colony). 4 ome cc plocghan (Sep. er) 5 i fdr, 6 Wel vegas toa) . ® ce omen pores (Cp A) —__ Levee isl amt mee). otto me VT) ee 11 Venera ah ial Ve Ceomety oe Tame TAL ont ako an 20m). ADU enh Ler Yenc a tet mn Ley) Weve) et aran rs deere ut elocener m= pepe esc cu =ryebre cba condonipay veonera ‘Mitral Pathology (MeCarthy, PM) s18-= Version 1.0 (June, 2006) tn) Cheats (oot (AMeteps ea) Fite ropa CINpted Ch naegeted et epatod adpatos Binaepates neat Drea Dieses Diego Chnrpates area Diisreeeed Dives Div eats (Naps Datseptos Diistepates Clete Caveat bg 8 8 NMH 000029