MitraClip: Treating Mitral Valve Regurgitation at Northwestern

Program overview

The Transcatheter Valve Program (TVP) at Northwestern’s Bluhm Cardiovascular Institute (BCVI) routinely provides both commercial and investigational treatment options to the high surgical risk patient population requiring treatment for all valvular heart disease.  Since 2008, our program has performed over 450 advanced transcatheter valve procedures including transcatheter aortic valve replacement (TAVR), transcatheter pulmonic valve replacement, and transcatheter mitral valve repair (TMVr).  Our mitral valve repair program has seen significant growth since its inception in 2012. We have performed over 40 TMVr procedures (investigational and commercial) in our cath lab using the Abbott MitraClip device. The TMVr program consists of a multidisciplinary team: cardiac cath lab personnel, valve clinic personnel (with a dedicated nurse practitioner [NP], nurse and a scheduler), and dedicated physicians. The physician team is led by Dr. Mark Ricciardi and also consists of Drs. Charles J. Davidson (interventional cardiology), S. Chris Malaisrie (cardiothoracic surgery), Patrick McCarthy (cardiothoracic surgery), Jyothy Puthamana (echocardiography), and James Thomas (echocardiography).  

Who are we treating?  

The MitraClip device is commercially available to the high surgical risk patients suffering from symptomatic, degenerative mitral valve regurgitation. Patients are referred from both internal and external sources. Northwestern is also participating in the COAPT clinical trial, which is investigating TMVr for heart failure due to functional mitral valve regurgitation. 

How did we get started?

Due to a keen interest in the treatment of both valvular heart disease and heart failure, we became involved in the early trails of TAVR and TMVr (namely COAPT). The infrastructure for transcatheter valve therapy allowed us to become early adopters of MitraClip when it became commercially available in 2012.  

What is our TMVr process? 

The key to the success of the TMVr program is the multidisciplinary approach. Each team member is important. Initial contact with the patient is often made by a patient service representative or new patient coordinator. These personnel are trained to recognize key terminology that would indicate a patient is being referred for a TMVr.  These patients are then referred to valve clinic.  The valve clinic provides a comprehensive evaluation of all valvular heart disease being considered for catheter-based intervention by both interventional cardiology and cardiac surgery. The patient’s records are screened for necessary pre-evaluation testing by the new patient coordinators, valve nurse, and nurse practitioner. If appropriate, these patients are then scheduled, prior to their consultation, for any necessary testing such as transthoracic echocardiogram (TTE) or transesophageal echocardiogram (TEE). Once in valve clinic, the patients are evaluated independently by each specialist to determine diagnosis, surgical risk, and course of treatment.  Any additional testing recommended, such as evaluation of coronary anatomy, is scheduled after the consultation by the dedicated TVP scheduler.  

Thorough procedure planning is a key component in the success of the MitraClip procedures at Northwestern. Following completion of testing and evaluation, the patients are presented for multidisciplinary review by the Transcatheter Mitral Valve team. This team is comprised of physicians specializing in echocardiography, interventional cardiology, cardiac surgery and congestive heart failure. In addition to the physician team members, our mitral valve research coordinators, dedicated TVP scheduler, registered nurse, and advanced practice nurse are active participants at the case review. The physician team members review the TEE and other available imaging together, and utilize the strengths of each member of the multidisciplinary team in order to plan the approach to each individual valve procedure. This is a regularly scheduled meeting which allows our team to coordinate care for the patients while ensuring the care providers are in agreement on valve disease etiology, surgical risk and treatment strategy.   

Generally, one to two weeks prior to the scheduled MitraClip procedure, the patients have a pre-operative visit with the nurse practitioner. General health history, medications, and procedural concerns are addressed. The patients are screened at that time for presence of adequate home care and post procedure care plans. During this visit, the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is completed as well as the Transcatheter Valve Therapy (TVT) registry-required six-minute walk test. Patients then undergo a series of pre-operative testing including blood work, urinalysis, chest radiograph, and electrocardiogram. This testing is reviewed by the nurse practitioner for completeness prior to the planned MitraClip procedure.  

MitraClip setup/procedure

Staff/physicians in lab:
1 to 2 circulators (initially for setup);
1 monitor/recorder;
1 interventional cardiologist;
1 interventional senior cardiology fellow;
1 cardiac surgeon;
1 cardiologist trained in echocardiography who runs the TEE machine during the procedure;
1 Abbott clinical specialist;
1 anesthesia team member (resident/attending or CRNA).

The TMVr procedure: MitraClip

The day of procedure, the patients are admitted to the cardiac recovery and observation unit (CROU) for pre procedure preparation. The patients receive intravenous access, updated laboratory work if needed, and are evaluated by the anesthesia team. During this process, the cath lab team is setting up for the procedure. The equipment required for these procedures includes the Abbott MitraClip system and standard transseptal puncture equipment. Most of the equipment existed in our cath lab prior to establishing the procedure at NMH. The single-use MitraClip system consists of a steerable guide catheter, the MitraClip delivery system, and a single clip. The reusable stabilizer system is kept in the cath lab and sterilized after each procedure. This is the only piece of equipment not routinely used in cath labs.

Once the cath lab team has set up the stabilizer system, the physician manipulates the MitraClip delivery system to deploy the clip(s) within the mitral valve. Currently, all of our cases are performed under general anesthesia. Monitoring for the MitraClip procedure includes non-invasive blood pressure, 12-lead electrocardiogram, oxygen saturation monitor, and radial arterial line. A time out and huddle are performed by the cath lab staff and interventional attending physician prior to anesthesia induction.  

TMVr procedure setup

The TMVr procedures require two separate, sterile workspace setups. The first is the basic cath lab table. The second table is the MitraClip prep table, which is a bit longer to accommodate the length of the MitraClip system. The interventional cardiologist or cardiac surgeon prime the MitraClip system with the assistance of the circulating nurse.  Heparinized saline and tubing is connected via sterile technique to the MitraClip system.  Transseptal access is obtained by the interventional cardiologist utilizing TEE guidance. Unfractionated heparin is administered to achieve an activated clotting time greater than 250 seconds. The echocardiographer is essential for imaging guidance during clip deployment.  

Post procedure plan

Once the procedure has been successfully completed, the MitraClip sheath is removed and hemostasis achieved with a “figure of eight” subcutaneous suture. The patients are extubated in the cath lab and then admitted to the cardiac care unit (CCU) for observation and monitoring overnight. The patients are admitted to the CCU, then cardiac step-down, and are cared for by cardiac nurses in these areas. Arterial monitoring and indwelling urinary catheters are routinely removed once the six-hour bed rest is complete. Ambulation is strongly encouraged on the day of procedure.  

The patients are discharged home after a brief hospitalization, usually 1 to 2 days. The patients are given a loading dose of 300mg clopidogrel post procedure, then continue on dual antiplatelet therapy (aspirin 81mg and clopidogrel 75mg) for a period of 6 months, with aspirin therapy continued indefinitely. For patients on chronic anticoagulation therapy, aspirin and oral anticoagulation are utilized. The follow-up for these patients include a registry-required 30-day and 1-year evaluation with the TVP as well as TTE, blood work, EKG, and chest radiograph. The patients are all strongly recommended to take part in phase 2 cardiac rehabilitation at a site close to their home, in order to enhance their endurance in the setting of the newly repaired valve. Antibiotic prophylaxis for prevention of bacterial endocarditis is recommended as per valve replacement guidelines. 
Data collection and tracking:

The preliminary work up, clinical data and outcomes related to the TMVr procedure is abstracted for inclusion in the Society of Thoracic Surgery (STS) TVT registry. The TVT registry has a specific reporting structure for the transcatheter mitral valve procedures.  General demographic information, history, and risk factors, as well as procedure-specific information, are collected. The TVT registry requires clinical data to be collected at 30 days and one year post procedure.  

Instrumental team members in our success

Critical to any TVP is the cardiac catheterization lab team. Integral to success in MitraClip procedures is a strong, knowledgeable, and well-trained cath lab personnel. The team is responsible for procedure preparation, patient monitoring, patient positioning, and device preparation. The nurses and radiologic technologists are experts in care of the patient undergoing transcatheter valve treatment and active participants in the procedure. All mitral valve catheter-based procedures are performed in our cath lab in coordination with the cath lab team, interventional cardiologists, cardiac surgeons, interventional echocardiographers, and cardiac anesthesiologists.   

The Invasive Cardiology Operations Coordinator, Lynda Buccellato, is another key component to the team here at Northwestern. She is a nurse whose background includes 6 years medical/ICU nursing and 12 years in the cardiac cath lab. She is responsible not only for the day-to-day operations here in invasive cardiology, but also is a key component to the training of our nurses. She also monitors outcomes and quality indicators within the interventional cardiology program, and leads process and quality improvement initiatives.  

The TVP Coordinator, Abby Doerr, is an integral member of the MitraClip team. The TVP coordinator is a nurse practitioner with 10 years of experience in cardiac, vascular, and neurovascular interventional nursing. She is fellowship trained as an advanced neurovascular practitioner and certified as a cardiac vascular nurse (CVRN). Her role includes pre-procedure medical record review, pre-procedure evaluation, and post-procedure follow-up. Outside of direct clinical responsibilities, this role includes leading quality and process improvement initiatives within the valve program. She is responsible for ensuring that pre and post procedure documentation is adequate for the requirements of the STS/ACC Transcatheter Valve Registry (TVT) Transcatheter Mitral Valve Procedures – Leaflet Clip. This role serves as a connection between the patients and the MitraClip procedural team.  

Additionally, we utilize a dedicated TVP nurse clinician, Rebecca Dominy, within the valve clinic. This nurse brings 4 years of cardiology and general medicine nursing experience to the team. She is responsible for pre-procedure screening and evaluation of the transcatheter valve patients, including those undergoing evaluation for MitraClip. This nurse provides the team with frailty assessments, quality of life evaluation using KCCQ-12, and coordination of care for the TAVR patients.  

What are the keys to our success with MitraClip for treatment of mitral valve regurgitation?

• Multidisciplinary approach
• Well-trained, educated, knowledgeable team, including:
  • Cardiac cath lab team 
•     nurses and technologists
  • TVP coordinator
  • Valve Clinic APN and RN
  • CCU team and nurses
• In-depth procedure planning with multidisciplinary team
• Supportive leadership and administration within Northwestern and the BCVI 

Recommendations for future programs at other facilities:

• Establish your readiness: evaluate the prevalence of symptomatic mitral valve regurgitation in your current program.
• Determine who your operator team will include.
• Develop your patient screening, pre-procedure tracking and outcome management process.
• Train your teams: operators, cath lab staff and valve clinic staff.

Questions? Please feel free to contact a member of our team!  

Abby Doerr, Transcatheter Valve Program Coordinator
Northwestern Bluhm Cardiovascular Institute
251 East Huron Street
Feinberg Pavilion, Suite 8-530
Chicago, IL 60611
adoerr@nm.org
Phone: 312-694-4226

Lynda Buccellato, Invasive Cardiology Operations Coordinator
Northwestern Bluhm Cardiovascular Institute
251 East Huron Street
Feinberg Pavilion, Suite 8-530
Chicago, IL 60611
lonik@nm.org 
Phone: 312-694-4799

Mark Ricciardi, Director, Cardiac Catheterization and Interventional Cardiology
Northwestern Bluhm Cardiovascular Institute
676 North St Clair St, Suite 600
Chicago, IL 60611
MRICCIA1@nm.org
Phone: 312-926-2826
www.heart.nmh.org

Disclosures: Abbigayle Doerr and Lynda Buccellato report no conflicts of interest regarding the content herein. Dr. Ricciardi reports he is on the Abbott advisory board and has been on the Abbott speakers bureau in the past.