Most Sacred Heart of Jesus Cardiology and Valvular Institute

Nalini M. Rajamannan, MD, FACC

Most Sacred Heart of Jesus Cardiology
Corvita
Visiting Adjunct Scientist Mayo Clinic Telephone 920-451-4611
703 N 8th St Suite 303 Fax 920-451-4614
Sheboygan, WI

May 11, 2021

VIA E-MAIL

J. Landis Martin J. Landis Martin

Chairman of the Board of Trustees Chairman and Managing Director of Platte River
633 Clark Street, Rebecca Crown Center 2-112 Equity
Evanston, IL 60208 200 Filmore Street, Suite 200
Admin-planning@northwestern.edu Denver, CO 80206
trustee@northwestern.edu info@platteriverequity.com

Marilyn McCoy Julia Uihlein, PhD

Vice President of Administration and Planning Former Northwestern University Board of Trustee
633 Clark Street, Rebecca Crown Center 2-112 Assistant Adjunct Professor of Bioethics and Medical
Evanston, IL 60208 Humanities and Pediatrics
mmccoy@northwestern.edu Medical College of Wisconsin
Center for Bioethics and Medical Humanities
8701 Watertown Plank Road
Milwaukee, WI 53226
juihlein@mcw.edu

Re: Dr. Nalini Rajamannan/Heart Valve Matters

Dear Mr. J. Landis Martin, Ms. McCoy, and Dr. Uihlein,

I am writing with respect to matters related to my work with heart valve annuloplasty rings.

In May 2007 the Journal of Thoracic and Cardiovascular Surgery published an abstract of the results of the
study protocol 1532-004, which was directed by Dr. Patrick M. McCarthy. (See Exhibit A.) I am listed as the
second author. A few months later, Northwestern University IRB terminated the study on July 17, 2007 as
reported in the Daily Northwestern story in May 2019. (See Exhibit B
(https://dailynorthwestern.com/2019/05/23/top-stories/years-after-surgery-documents-renew-patients-
malpractice-claims-northwestern-memorial-doctor/).)

By means of this letter, I am requesting that Northwestern University retract my name from the published
abstract in the Journal of Thoracic and Cardiovascular Surgery (see Exhibit A) because I believe that patients
receiving the valves were not provided with informed consent, adverse events went unreported in the abstract
publication, and Dr. McCarthy failed to obtain an investigational device exemption from the FDA in 2006.
Additionally, I have ongoing concerns about the failure to monitor acute and long term adverse events in
patients who underwent Dr. McCarthy’s experimental mitral valve repair procedure as well as the failure of the
IRB to bring Dr. McCarthy into compliance following termination of the study in 2007. I am requesting
confirmation by Monday, May 17, 2021, that you will remove my name from the published abstract. My
attorney has sent a similar letter making this same request to Northwestern’s General Counsel, Stephanie M.
Graham .

As you are aware, during my tenure as the former Valve Director and Associate Professor at Northwestern
University, I first reported my concerns about Dr. McCarthy’s study in 2007, and then to the Board of Trustees
in 2009. And as reported by the Daily Northwestern, several patients have had heart attacks and reoperations
due to the experimental annuloplasty ring, and at least one patient has died. Going forward, I am interested in
meeting with and providing further information to the Board of Trustees regarding Dr. McCarthy’s continued
unauthorized use of protocol 1532-004. I currently have several patients who have been injured by the
experimental annuloplasty ring and are seeking further information regarding how their surgeries became part
of this experimental study. I hope that Northwestern will be able to assist these patients.

Respectfully,

Nalini M. Rajamannan, MD
Most Sacred Heart of Jesus Cardiology and Valvular Institute
CorVita Science and Research Foundation
Visiting Adjunct Scientist Mayo Clinic

Enclosures
AATS: Novel Surgical Approach to Myxomatous Mitral Valve Repair 11/26/12 10:45 AM

Home | Association | Membership | Publications | CME Meetings | For CT Surgeon | For Resident | For Medical Student

Members Only Area Apply for Membership Find a CT Surgeon

Novel Surgical Approach to Myxomatous Mitral Valve Repair

Patrick M. McCarthy1, Nalini M. Rajamannan2, Edwin C. McGee1, Vera H. Rigolin2, Qiong Zhao2, Anna L. Huskin2, Haris Subacius2,
Stacie Landron2, Susan Underwood2, Robert O. Bonow2; 1Division of Cardiothoracic Surgery, Northwestern University/Northwestern
Memorial Hospital, Chicago, IL; 2Northwestern University, Chicago, IL

Objective: Patients with myxomatous (Myxo) mitral regurgitation (MR) can present complex surgical challenges. This study was designed
to assess a new surgical strategy and ring technology in patients who underwent surgery for Myxo mitral disease.

Methods: From 4/2004 to 9/2006, 128 patients underwent primary mitral valve repair (MVR) for Myxo MR. In Group I, 92
patients underwent repair with conventional annuloplasty rings (Physio, n=70) and surgical techniques. In Group II, 36 patients
(3/06 to 9/06) underwent MVR with a new Myxo ETlogix ring. This ring has a larger orifice to accommodate elongated leaflets, a
29% increase in AP diameter, and a 3D design that pulls the posterior leaflet away from the outflow tract to reduce systolic
anterior motion (SAM). Ring sizing for Group II was calculated by direct measurement of the anterior and posterior leaflet
heights. Baseline patient characteristics between the groups were similar, except for gender (76.1% males in Group I vs. 55.6%
in Group II; p=0.022).

Results: Myxo MR was repaired in all patients. Quadrangular resection was performed in 77.2% vs. 75.0% of cases in Groups I
and II, respectively. Sliding annuloplasty was performed in 28.3% of Group I patients and was not required in Group II
(p<0.001). One operative mortality occurred in Group I (1.1%) and 0 in Group II. Median ring size was 32mm (range 26-40) and
34mm (range 26-36) in Groups I and II, respectively. After repair, overlap of the leaflet coaptation at A2 was 5.7±2.1mm and at
P2 was 6.2±1.8mm in Group II. By echo, the mean distance from the coaptation point to the septum was 17.3±3.4mm (range
11-24) in Group II. Median gradient was 3.5mmHg at discharge and 3.4mmHg at follow-up and did not differ between groups. In
Group I, mitral leaflet SAM occurred in 4 patients and chordal SAM in 1 patient (5.4% overall). In Group II, mitral leaflet SAM
was not observed and chordal SAM occurred in 1 patient at late follow-up (2.8% overall). SAM in Group I resulted in early
reoperation for 2 patients (2.2%), 1 requiring valve replacement, and 2 additional patients await reoperation. MR is depicted in
the table (mean ±SD).

Conclusion: Surgical repair of Myxo mitral disease with this etiology-specific ring significantly reduced MR, simplified the repair
technique by eliminating the need for sliding annuloplasty, without the subsequent development of SAM.

Back to Annual Meeting

Back to Program Outline

Policies | Find a Surgeon | About | Contact We Model Excellence

Copyright © 2012 American Association for Thoracic Surgery
All rights reserved. IMPORTANT REMINDER: The preceding information is intended only to provide
general guidance and not as a definitive basis for diagnosis or treatment in any particular case.
It is very important that you consult a doctor about any specific medical problem or question.

http://aats.org/annualmeeting/Abstracts/2007/T9.cgi Page 1 of 1

Exhibit A
Exhibit B
Exhibit B
Exhibit B
Exhibit B
Exhibit B
Exhibit B
Exhibit B