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The Future of Cardiovascular Biomedicine

The Future of Cardiovascular Surgery


Richard J. Shemin, MD

C ardiac surgery has been a vibrant field since the early


pioneering procedures were attempted, became success-
ful, and eventually reproducible. From the successful closure
coronary intervention to the right coronary artery and cir-
cumflex vessels and the robotic left internal mammary artery
harvest with an off pump beating heart minimal access left
of a patent ductus arteriosus in 1938 and the Blalock-Taussig internal mammary artery to left anterior descending coronary
shunt, discovery and innovation have been the hallmarks of artery anastomosis. Performing these procedures in a hybrid
cardiac surgery.1 Dr John Gibbon’s first clinical use of the room allows surgical and interventional procedures to be per-
heart lung machine in 1953 opened the door to diverting the formed seamlessly.
circulation and oxygenating the blood, making open heart
surgery to repair congenital defects and valvular lesions Valvular Heart Disease
possible.4 The development of safe myocardial preservation Exciting advances have occurred with the introduction of
with solutions to protect the heart opened the surgical world transcatheter aortic valve replacement (TAVR) clinical trials
to complex prolonged cardiac procedures and made cardiac and subsequent approval of the devices for the treatment of
transplantation feasible. Routine preservation of myocardial aortic stenosis. The burden of aortic stenosis, a very lethal
structure and function for periods of several hours has been condition once symptoms develop, is well documented. Many
achieved. patients are untreated because they are deemed too old, too
The future holds dramatic advances that will transform frail, or have too many comorbidities to undergo conventional
the cardiac surgeon, in part, into an interventionalist with new or minimally invasive cardiac surgery.
skills in diagnostic and therapeutic approaches to structural The results from TAVR trials for the inoperable aortic ste-
heart disease. nosis subset of patients in comparison with medical therapy
have been positive and led to the initial US Food and Drug
Ischemic Heart Disease Administration approval of these devices. Further results,
The burden of ischemic heart disease in our society challenges from the trials between 2 and 5 years after a TAVR procedure
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the multiple approaches used to treat coronary artery disease. in comparison with conventional surgical aortic valve replace-
Advances in primary and secondary prevention have finally ment, have shown equivalence in procedural mortality and
had an impact; however, current therapy for acute myocardial short-term survival.6
infarction is primarily culprit vessel percutaneous coronary In addition to the frail and elderly patients with multiple
intervention or occasionally coronary artery bypass surgery. comorbidities now having the TAVR option, the future will
Surgery has been necessary for the mechanical complications see these devices used in lower-risk and younger populations.
of myocardial infarction including mitral regurgitation, ven- Valve tissue durability will become an important concern as
tricular septal defect, or cardiac rupture. However, the future use expands in this way. Future directions in tissue prepara-
will see the effective use of percutaneous closure devices for tion and preservation will focus on enhancing durability: the
postinfarction ventricular septal defect and the use of a variety vision of valve leaflets bioengineered with custom-designed
of devices for acute postinfarction mitral regurgitation. scaffolds seeded with the patient’s own stem cells that will
Treatment of unstable angina, chronic stable angina, or differentiate into autologous leaflet tissue capable of regenera-
left main disease remains a dynamic field with competing tion and remodeling. The result may be a more durable tissue
interventional and surgical approaches. Data from random- than the current glutaraldehyde-fixed pericardial tissue.
ized clinical trials and larger registries have helped define sub- Many of the early TAVR problems have been resolved
groups and have informed us of some of the best treatment with improved design both of the valves and of their delivery
strategies for patient subsets. Professional cardiology and sur- systems. The ability to perform more of the procedures from
gical societies have collaboratively developed appropriate-use a transfemoral approach has resulted from the redesign of the
criteria and practice guidelines. These efforts will continue to delivery systems. In addition, fabric skirts around the bottom
evolve and help focus physicians on best practices, reducing of the valves have helped reduce the incidence of paravalvular
practice variation and unnecessary or harmful procedures. leak, which contributes significantly to postoperative morbid-
Efforts to explore new ways to combine interventional and ity and mortality over time. The risks of periprocedural stroke
less invasive surgical techniques are being instituted and stud- have been markedly reduced by improved delivery systems
ied. An example, in 3-vessel disease, is the use of percutaneous that can be shaped and flexed to deliver the valve into the

From Ronald Reagan UCLA Medical Center; David Geffen School of Medicine at UCLA, Los Angeles, CA.
Correspondence to Richard J. Shemin, MD, 100 UCLA Medical Plaza, Suite 730, Los Angeles, CA 90095. E-mail Rshemin@mednet.ucla.edu
(Circulation. 2016;133:2712-2715. DOI: 10.1161/CIRCULATIONAHA.116.023545.)
© 2016 American Heart Association, Inc.
Circulation is available at http://circ.ahajournals.org DOI: 10.1161/CIRCULATIONAHA.116.023545

2712
Shemin   Future of Cardiovascular Surgery   2713

aortic valve position, minimizing contact with the aortic arch. surgery for it bears significant risks. A reliable transcatheter
Future improvements will continue in delivery technologies tricuspid valve has great promise.
and other valve designs that will compete with the 2 currently The use of transcatheter valves for valve-in-valve posi-
approved US Food and Drug Administration valves. tioning will become routine in the future. The uses of these
The development of cerebral protection devices to be valves to treat structural failure of bioprosthetic valves have
used to reduce further neurological events is moving for- shown promising results in the aortic and the pulmonic posi-
ward. The transapical, transaortic, and subclavian approaches tion. There is a need to have a percutaneous approach to treat
remain options when a femoral access is not possible. A major failed bioprosthetic valves and repairs in the mitral position.
advance is the ability to perform these procedures with con- Specific knowledge of the geometry of the failed bioprothesis
scious sedation instead of general anesthesia. This approach or annuloplasty band/ring is paramount to determine the size
avoids intubation, transesophageal echocardiography, and an of the percutaneous device.
obligate stay in the intensive care unit. The goal is to reduce The option of transcatheter valves used valve-in-valve has
morbidity, length of hospitalization, and procedural cost. expanded the choice of a bioprosthetic valve to a younger age
Real-world large data sets will be analyzed to study prac- group. The hope is that early bioprosthetic valve deteriora-
tice patterns, determine outcomes, and identify best practices. tion requiring open surgical reoperation can be obviated by
The use of large registries in the field of cardiac surgery and the valve-in-valve technique extending the function of the
cardiology has been well established and will continue to be valve without open reoperation.12 The expected impact will
expanded and funded into the future. These data will direct be a reduced need for mechanical valves that require obligate
future research, identify knowledge gaps, and establish best life-long anticoagulation and its attendant morbidity and mor-
practices. tality. There are concept designs for valves that can be placed
The expansion of transcatheter device implantation tech- in the inferior vena cava to reduce the consequences of severe
niques for the mitral valve will be the next frontier for device right heart failure’s impact on the development of cardiac cir-
development, delivery systems, and clinical trials. The cur- rhosis and other comorbidities that develop from high venous
rently approved MitraClip, which is based on the Alfieri stitch pressure.
concept, has been approved in the United States for prohib- One of the most exciting and positive impact of the trans-
itive-risk surgical patients with mitral valve regurgitation catheter valve trials in the United States, which has become a
attributable to degenerative disease. Expansion of this tech- new standard in clinical practice, is the development of Heart
nology to other subsets of mitral regurgitation (eg, ischemic Teams. Cardiologists (both clinical and interventional) and
mitral regurgitation) and eventually to lower-risk populations cardiac surgeons evaluate all high-risk patients as an inte-
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will be the next direction for investigation. grated team in a joint clinic setting and make a single joint
Devices for coronary sinus implantation are under devel- recommendation after consideration of the individual needs of
opment to create an annuloplasty interventionally. There are the patient. The patient may have to continue medical therapy
many technical challenges in this area that will need to be or be a candidate for a TAVR or surgical aortic valve replace-
overcome to produce effective devices. The surgical literature ment procedure. This is a very patient-centric approach and
supports the combined use of an annuloplasty with the Alfieri eliminates the usual dynamics in clinical decision making
edge-to-edge repair to maximize the results and durability of that often results from competing technologies and physicians
the repair. competing with each other to perform a procedure. In addition,
Transcatheter mitral valve replacement devices have many the interventional cardiologist and cardiac surgeon are both
design and delivery challenges. These devices are in vari- scrubbed and perform the procedure together, further align-
ous stages of development. The mitral valve is a much more ing incentives. The TAVR payment determination by Centers
difficult valve position and structure for which to develop a for Medicare & Medicaid Services has resulted in the TAVR
replacement device in comparison with the aortic valve posi- procedure having shared payment between surgeons and
tion.7–11 The access via the left ventricular apex will proba- interventional cardiologists. Thus, the physician stakeholders
bly be the most efficient and direct approach used; however, are aligned in the patient’s best interest both in joint decision
alternative antegrade approaches through the venous system making, the joint technical performance of the procedure, and
with a transseptal puncture to deliver the device into the left financially, as well. This model has led to improve dynamics
atrium will eventually be developed to reduce the risk of the and cooperation between the healthcare professionals. This
procedure and avoid a surgical incision. Device positioning, approach has reversed a trend that has been adversarial in the
stabilization, and the capture of the anterior leaflet to prevent treatment of ischemic heart disease resulting from the compe-
systolic anterior motion–induced left ventricular outflow tract tition between percutaneous coronary artery intervention and
obstruction and chordal entanglement will all be challenges coronary artery bypass surgery.
that need to be overcome in developing these devices and the
techniques for their implantation. Cardiac Transplantation and
Expansion of the transcatheter valves to treat tricuspid and Mechanical Circulatory Support
pulmonic valve lesions will continue to evolve. The current The major advances expected in the arena of cardiac trans-
use of the Melody valve in the pulmonary position, primarily plantation are continued improvement in control of immuno-
for congenital pulmonic stenosis, is well established. Tricuspid suppression, reduction of infections, monitoring for rejection
regurgitation is a serious valvular lesion, and conventional without the need for endomyocardial biopsy, and advances in
2714  Circulation  June 21, 2016

organ preservation and transport. Currently, with cardioplegic common blood type, or high degree of sensitization will prob-
arrest of the donor heart followed by cold storage, the upper ably be accepted for devices approved as destination therapy.
limit of reliable myocardial protection to prevent primary Destination therapy patients will live with the device for their
graft dysfunction is ≈5 hours. Techniques and technologies rest of their life. Mechanical circulatory support devices for
to harvest the heart and to place the organ in a sterile device this category of patients must be reliable, they must be durable,
that allows coronary perfusion with donor blood perfusing the and they must have the capacity for extended portable battery
heart and allowing the heart to beat in an empty state is under power of >4 hours. Future improvements in battery life technol-
investigation. The organ procurement system allows transport ogy and transcutaneous power transmission are essential. The
of the donor heart in the device. The heart is then rearrested in future goal is to avoid the percutaneous drive or power line. The
the recipient’s hospital and transplanted.13,14 Initials trials dem- drive line is a common site for infection, morbidity, and death.
onstrate noninferiority to standard cold storage with transport Thromboembolic events, pump malfunction attributable to
of the donor heart in donor runs <6 hours. New trials are being thrombosis, and the development of gastrointestinal bleeding
developed for extended time of cardiac storage. If these trials with nonpulsatile pumps are clinical problem areas under active
are successful, a broader range in distance and the time of day investigation for required solutions. Clinicians and device man-
the heart can transplanted will be possible. The heart can be ufacturers are seeking best practices and standardization of the
metabolically monitored on the storage device, as well, which protocols for anticoagulation and implantation to reduce these
could prevent the implantation of a damaged organ and reduce complications. Improved biocompatible surfaces will be devel-
the serious problem of primary graft dysfunction. oped to reduce the adverse blood to surface interactions. A bet-
Mechanical circulatory support has had rapid growth. The ter understanding of the physiology of nonpulsatile circulation
devices are becoming more efficient with reductions in size, on the cardiovascular system and end organs will be required to
and they are more likely to be continuous-flow than pulsatile advance the safety of long-term circulatory support.
pumps. The US Food and Drug Administration has approved Regenerative medicine’s application to cardiovascular dis-
many such devices, both for destination therapy and also for eases holds great promise but requires further understanding
a bridge to transplantation. A total artificial heart used as a and procedural breakthroughs. The goal is to regenerate the
bridge to transplantation in both adult (70 mL) and pediat- myocardium with stem cells or scaffold patches seeded with
ric size (50 mL) are now available. This device requires the stem cells. Success can change the current reliance on car-
removal of the ventricles and has been particularly helpful in diac transplantation and assisted devices. The collaboration of
cardiac restrictive diseases and chronic posttransplant rejec- basic science and translational clinical research to impact the
tion. Nonpulsatile axial flow devices of the future will become growing problem of end-stage cardiac failure will be essential
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smaller, more efficient, and implanted with minimally inva- to advancing new therapeutic options for this important public
sive or percutaneous approaches. health problem. Additional applications in the vascular system
Advances are needed in surface compatibility to reduce the are a priority for regenerative cardiovascular medicine.
thrombogenicity of these devices leading to device malfunc-
tion and thromboembolic ischemic stroke. New more effec-
tive anticoagulants with minimal side effects are required.
Atrial Arrhythmia
Future directions for cardiac arrhythmia surgery for atrial
Understanding each person’s individual response to a particu-
fibrillation will continue to evolve. Attempts to make this
lar drug will allow improved efficacy and minimize compli-
cations. There is an increasing need for implantable devices procedure less invasive will require a hybrid approach. The
to support the right ventricle in addition to the left ventricle, concept of the Heart Team applied to the maze procedure
because biventricular failure is a major high-risk clinical prob- will foster the essential collaboration of the surgeon and
lem. The current practice of total circulatory support will be electrophysiologist.
challenged by investigations studying whether or not smaller The surgeon can easily occlude the left atrial appendage
devices that deliver partial circulatory support will be sufficient. with an external clip and perform the pulmonary vein isola-
Most mechanical circulatory support has been used as a tion performing a box lesion by using a minimally invasive
bridge to transplantation to stabilize the patient through the approach. The electrophysiologist can map for lesion isolation
period of low output associated with end-stage heart dis- and perform the left atrial isthmus lesion and a right side flut-
ease. However, the concept of a bridge to a decision in very ter lesion. This combined approach has great appeal to have
ill patients continues to be a clinical reality. Many of these a complete procedure in 1 setting performed by both electro-
patients are too sick to determine whether or not they will ever physiology and cardiac surgeon. Trials are needed to dem-
become a transplant candidate or if a lifetime of circulatory onstrate improved efficacy with a single procedure. Payment
support (destination therapy) is appropriate. reform is necessary to support the collaboration. An integrated
The extended use of centrifugal pumps, such as the hybrid procedure suite is essential to provide the mapping,
CentriMag, has become quite popular as a bridge to decision integrated imaging, and appropriate surgical and interven-
making; these can be used for months. Therefore, the patient tional environment.
who was not thought to be a transplant candidate can be sup-
ported on these devices until a decision can be made by the Minimal Access Surgery
transplant selection committee. Less invasive cardiac surgery includes small incisions, robotic
The patient who is not a transplant candidate or the patient technology, and the use novel biocompatible cardiopulmonary
who may never receive a transplant because of large body size, bypass circuits or procedures without cardiopulmonary bypass
Shemin   Future of Cardiovascular Surgery   2715

circuits. These approaches reduce complications, blood usage, 3. Blalock A, Taussig HB. The surgical treatment of malformations of the
heart in which there is pulmonary stenosis or pulmonary atresia. JAMA
infections, postoperative pain, and wound-healing problems.
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An important example is a small minimal access inter- Gibbon. Ann Thorac Surg. 2003;76:S2220–S2223.
costal right thoracotomy mitral valve repair with or without 5. Rose EA, Moskowitz AJ, Packer M, Sollano JA, Williams DL, Tierney
AR, Heitjan DF, Meier P, Ascheim DD, Levitan RG, Weinberg AD,
the use of the Da Vinci Robot. The small-incision approach to Stevenson LW, Shapiro PA, Lazar RM, Watson JT, Goldstein DJ, Gelijns
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Vinci Robot to harvest the left internal mammary artery and
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rior descending coronary artery anastomosis. Other less inva- 7. Tang GH, George I, Hahn RT, Bapat V, Szeto WY, Kodali SK.
sive approaches will be enabled when performed in hybrid Transcatheter mitral valve replacement: design implications, potential
pitfalls and outcomes assessment. Cardiol Rev. 2015;23:290–296. doi:
operating room/catheterization laboratory suites equipped 10.1097/CRD.0000000000000086.
with highly integrated imaging capability. Minimal access 8. Schueler R, Nickenig G, May AE, Schillinger W, Bekeredjian R, Ouarrak
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dures hold great promise. Widespread adoption will require of 778 prospective patients from the German TRAMI registry focusing
trials to prove these concepts and new procedures accomplish on baseline renal function. EuroIntervention. 2015;11:. doi: 10.4244/
the goals of efficacy, durability, and cost-effectiveness. EIJY15M09_07.
9. Abdul-Jawad Altisent O, Dumont E, Dagenais F, Sénéchal M, Bernier
M, O’Connor K, Bilodeau S, Paradis JM, Campelo-Parada F, Puri R, Del
Conclusion Trigo M, Rodés-Cabau J. Initial Experience of Transcatheter Mitral Valve
The future is bright for advances in the treatment of cardiac Replacement With a Novel Transcatheter Mitral Valve: Procedural and
6-Month Follow-Up Results. J Am Coll Cardiol. 2015;66:1011–1019. doi:
diseases. The cardiac surgeon is evolving into an interven- 10.1016/j.jacc.2015.06.1322.
tional cardiac specialist to complement conventional surgical 10. Taramasso M, Maisano F. Transcatheter mitral valve interventions: patho-
skills. The Heart Team has been a patient-focused advance that physiological considerations in choosing reconstruction versus transcath-
eter valve implantation. EuroIntervention. 2015;11(suppl W):W37–W41.
allows the expertise of all the relevant cardiovascular special-
doi: 10.4244/EIJV11SWA9.
ists to consult and recommend the best evidence-based treat- 11. Cohen HA, O’Neill BP. TMVR: continuing the paradigm shift in valvular
ment plan for each patient. Personalized medicine is enhanced heart disease therapy: hype or hope? J Am Coll Cardiol. 2015;66:1020–
by these strategies. Cost pressures will increase and continue 1022. doi: 10.1016/j.jacc.2015.06.1321.
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12. Erlebach M, Wottke M, Deutsch MA, Krane M, Piazza N, Lange R,


to challenge cardiovascular medicine. Therefore, therapies Bleiziffer S. Redo aortic valve surgery versus transcatheter valve-in-
that provide value, extend life, and relieve human suffering valve implantation for failing surgical bioprosthetic valves: consecutive
are essential. patients in a single-center setting. J Thorac Dis. 2015;7:1494–1500. doi:
10.3978/j.issn.2072-1439.2015.09.24.
13. Hawkey MC, Lauck SB, Perpetua EM, Fowler J, Schnell S, Speight M,
Disclosures Lisby KH, Webb JG, Leon MB. Transcatheter aortic valve replacement
None. program development: recommendations for best practice. Catheter
Cardiovasc Interv. 2014;84:859–867. doi: 10.1002/ccd.25529.
14. Sintek M, Zajarias A. Patient evaluation and selection for transcatheter
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