Download Minimally Invasive Cardiac Surgery

Minimally Invasive
Cardiac Surgery
John Bell-Thomson MD MBA
Chairman Department
Cardiothoracic Surgery
Mercy Hospital of Buffalo
Evolution of Minimally Invasive Heart
Surgery (MIHS)
Inception in 1991 by Heartport
Commercially available in 1996
Initial efforts on multi-vessel CABG
Heartport, industry, marketing
Multiple Problems
“HEARTPORT KILLS PATIENTS”
Wall Street Journal 1998
WALL STREET JOURNAL
KILLS HEARTPORT
Evolution of MIHS
Establishment and maintenance of
adequate perfusion(cannulation)
Myocardial Preservation
Optimal Exposure
The Heartport ® Platform
Heartport EndoPlege
sinus catheter
Heartport EndoVent
pulmonary catheter
Heartport EndoReturn
arterial cannula
Heartport EndoClamp
aortic catheter
Heartport venous
cannula
To Cardiopulmonary
Bypass Machine
The Heartport ® Platform
EndoClamp
aortic catheter
Heartport EndoPlege
sinus catheter
Heartport venous
cannula
Heartport EndoVent
pulmonary catheter
MIS: What is it?
•
•
•
•
Upper Mini Sternotomy-AVR
Intercostal Approach-AVR
Lower Mini Sternotomy-MVR
Mini Thoracotomy-MVR (what defines
“Mini”)
• Port Access Surgery-MVR
• Robotic Surgery-MVR,CABG
Surgeon Acceptance of MIVS
•
•
•
•
•
•
VISUALIZATION
Decreased bleeding
Eliminate Sternal wound complications
Minimize infection incidence
Faster recovery
Cosmetic result
Myocardial Preservation
Ventricular Fibrillation,
Systemic Hypothermia
Transthoracic Aortic
Crossclamping
Endoballoon use
Myocardial Preservation in MISMVR
Ventricular Fibrillation
 Advantages:
- No aortic manipulation
 Disadvantages:
- ?Adequacy of preservation
- Minimal annular distortion causes AR, resulting
in flooding of field
Myocardial Preservation in MISMVR
Aortic Cross Clamping
 Advantage: “Comfort” level with traditional
techniques
 Disadvantages
- Additional hole in the chest wall
- Potential damage to the PA: Bad Problem!
- Potential damage to LA: Worse problem
- Suture control of aortic cardioplegic site
- Alteration of incision to access Aorta in MVR
Myocardial Preservation in MISMVR
Endoballoon Use
 Advantages:
- No additional chest holes
- No aortic suture
- Safe, reliable, reproducible
- Both options of antegrade,retrograde
- Aortic root venting once deflation occurs
 Disadvantages
- Learning curve(avoidance of antegrade,
retrograde migration; learning deployment and
principles)
CT Angiography for MIHS
• MANDATORY for all MIHS candidates
• Chest, Abdomen and Pelvis
• AVR – Calcification of Ascending aorta,
retrograde perfusion if Intercostal Approach used.
Coronary Screening in younger pts.
• MVV – Size the aorta for EB, r/o important aortic
calcification, assess aorta, iliac and femoral
vessels for cannulation and retrograde perfusion.
Coronary screening in younger patients.
• Both AVR and MVV – r/o aortic arch anomalies.
•
•
Prevalence
In the United States, patients are often undertreated for both mitral
and aortic valve disease.
• Only 1 in 40 patients with moderate or severe mitral regurgitation
are surgically treated.(1-3)
• “Only 59% of the patients who should have had aortic valve
replacement according to the practice guidelines were actually
offered surgical treatment...” (4)
Patients are often not being referred or are opting out of surgery for a
variety of reasons that may include(5):
• Co-morbid disease, risk factors and age
• Perceived fear of traumatic nature of conventional surgery
• Patients concerns of body image/cosmesis, pain, time out of
work, etc.
1. U.S. Census Bureau, Population Estimates and Projections, 2008. Projected Population by Single Year of Age, Sex, Race, and Hispanic Origin for the United States: July 1, 2000 to July 1, 2050.
http://www.census.gov/population/www/projections/downloadablefiles.html
2. Nkomo, VT et al. Burden of valvular heart diseases: a population-based study. Lancet, 2006;368:1005-11.
3. Health Research International. U.S. Opportunities in Surgical Heart Valve Technologies. July 2009.
4. B J Bouma et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart. 1999;82:143-148.
5 Helium Market Research, Coady 051109; pages 25-34.
Why Minimal Incision Valve Surgery
A decade worth of clinical data
demonstrate that MIVS results can be
optimal, if not better than, open chest
valve surgery:
• Less surgical trauma
• Reduced blood loss
• Better cosmetics
• Faster recovery
• Greater patient satisfaction
6. Rosengart, TK, et al. Percutaneous and Minimally Invasive Valve Procedures. A Scientific Statement. Circulation, 2008;117. DOI:10.1161/CIRCULATIONAHA.107.188525
Symptoms and Physical Findings Should Also Be
Considered when Diagnosing Valvular Heart Disease7
• Dyspnea
• Paroxysmal nocturnal dyspnea (especially
when laying down)
• Fatigue (especially during exertion)
• Arrhythmia
• Edema of the feet or ankles
• Heart murmur
• Angina
• Syncope
7. Bonow, RO, Carabello, BA, Kanu C, et al. 2008 Focused Update Incorporated Into the ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart
Disease. Circulation 2008;118;e523-e661
Diagnosing Heart Valve Disease
•
•
•
Patients are often poor historians at reporting symptoms of valvular disease.
Clinical correlation of physical findings, reported symptoms, and diagnostic
tests should allow for early diagnosis and improved likelihood of full recovery.
•
What questions do you ask to elicit actual symptoms and their functional
significance as they relate to the disease process?
•
What initial diagnostic tests are most appropriate?
•
How far advanced is the disease process? It is imperative that both physician and
patient discuss the natural history of the untreated disease process.
Consider additional diagnostic tests to evaluate whether patient is an
appropriate candidate for MIVS
•
TEE is a primary diagnostic tool for surgeons to evaluate valve morphology,
function, and degree of aortic atheroma
•
Cardiac catheterization may be necessary to exclude concomitant coronary artery
disease
•
CT Angiography may be appropriate in high risk patients to exclude significant
aortic pathology
Consider referral to a surgeon prior to completing diagnostic tests
•
Improve patient understanding of functional significance of disease progression
•
Evaluate whether patient is appropriate candidate for MIVS, consideration of
ACC/AHA Guidelines
7. Bonow, RO, Carabello, BA, Kanu C, et al. 2008 Focused Update Incorporated Into the ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease.
Circulation 2008;118;e523-e661.
Initial Clinical Assessment of Mitral
Many patients are often unaware that they have mitral regurgitation; however,
symptoms most commonly identified are fatigue, shortness of breath, decreased
exercise capacity, and arrhythmias or atrial fibrillation.7
Evaluation should include looking for symptoms, signs of heart failure, and
physical indicators of severe mitral regurgitation.9
7. Bonow, RO, Carabello, BA, Kanu C, et al. 2008 Focused Update Incorporated Into the ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease.
Circulation 2008;118;e523-e661.
9. Enriquez-Sarano, M, et al. Mitral Regurgitation. The Lancet, 2009;373:1382-394.
10. Bonow, RO, Carabello, BA, et al. ACC/AHA 2006 guidelines for the management of patients with valvular heart disease. Circulation, 2006;114:e84-231.
2008 Focused Update Incorporated Into the ACC/AHA
2006 Guidelines Timing of Mitral Valve Surgery
Surgery Recommended
Class I
Surgery Not
Recommended
Class IIa
Class IIb should be considered
Class III
MV repair is reasonable in experienced
surgical centers for asymptomatic patients with
chronic severe MR with preserved LV function
(ejection fraction greater than 0.60 and endMV surgery is beneficial for patients
systolic dimension less than 40 mm) in
with chronic severe MR and NYHA
whom the likelihood of successful repair without
functional class II, III, or IV symptoms
residual MR is greater than 90%.
in the absence of severe LV
dysfunction (severe LV dysfunction is
defined as ejection fraction less than MV surgery is reasonable for asymptomatic
patients with chronic severe MR, preserved LV
0.30) and/or end-systolic dimension
function, and new onset of atrial fibrillation.
greater than 55 mm.
MV repair may be considered for
patients with chronic severe
secondary MR due to severe LV
dysfunction (ejection fraction less
than 0.30) who have persistent
NYHA functional class III–IV
symptoms despite optimal
therapy for heart failure, including
biventricular pacing
MV surgery is not indicated for
asymptomatic patients with MR and
preserved LV function (ejection
fraction greater than 0.60 and endsystolic dimension less than 40 mm)
in whom significant doubt about the
feasibility of repair exists
MV surgery is recommended for the
symptomatic patient with acute
severe MR
MV surgery is beneficial for
asymptomatic patients with chronic
severe MR and mild to moderate LV
dysfunction, ejection fraction 0.30 to
0.60, and/or endsystolic dimension
greater than or equal to 40 mm.
MV surgery is reasonable for asymptomatic
patients with chronic severe MR, preserved LV
function, and pulmonary hypertension
(pulmonary artery systolic pressure greater
than 50 mm Hg at rest or greater than
60 mm Hg with exercise)
MV surgery is reasonable for patients with
chronic severe
MR due to a primary abnormality of the mitral
apparatus and NYHA functional class III–IV
symptoms and severe LV dysfunction (ejection
fraction less than 0.30 and/or end-systolic
dimension greater than 55 mm) in whom MV
repair is highly likely.
Isolated MV surgery is not indicated
for patients with mild or moderate
MR
Miral Regurgitation
Decision Diagram
Mitral Valve Stenosis
Decision Diagram
MV repair is recommended over MV
replacement in the
majority of patients with severe
chronic MR who require surgery, and
patients should be referred to
surgical centers experienced in MV
repairRO, Carabello, BA, Kanu C, et al. 2008 Focused Update Incorporated Into the ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease. Circulation
7. Bonow,
2008;118;e523-e661.
Mitral Regurgitation is not Properly Diagnosed
•
•
66% (6/9) of asymptomatic patients and 47% (8/17) of patients cited with stable LV size had at least 1 indication for
surgery
Of 53 unoperated patients, 43 (81%) were followed up by cardiologist; only 5 (9%) were referred to cardiothoracic
surgeon for evaluation
Rationale for Not Referring to Surgery
n
Death
Cardiac Death
Asymptomatic
9 (17%)
1
0
Stable LVEF, stable chambers
17 (32%)
3
3
6 (11%)
1
1
10 (19%)
7
4
Patient refused
4
2
2
Died before planned evaluation
1
1
1
MR unrecognized
4
1
0
MR improved on subsequent echocardiogram
Comorbidities / risk
•
Surgical
MR. One
MRintervention
ignored occurred in just over half of patients with severe
2
1 or more indication
1 for intervention was
present in approximately three quarters of the unoperated patients, suggesting poor adherence to guideline
Total
53
17 (32%)
12 (23%)
recommendations.
11. Bach, David S., Mazen Awais, Hitinder S. Gurm, and Sarah Kohnstamm. Failure of Guideline Adherence for Intervention in Patients with Severe Mitral Regurgitation. Journal
of the American College of Cardiology. 2009;54: 860-65.
Asymptomatic Severe Mitral Regurgitation has
Significant Mortality With Medical Management
Mild regurgitation
Moderate
regurgitation
Severe regurgitation
Kaplan-Meier Estimates of the Mean (±SE) Rates of Overall Survival among Patients with Asymptomatic Mitral
Regurgitation under Medical Management, According to the Effective Regurgitant Orifice (ERO)
9. Enriquez-Sarano,
M. et al. N Engl J Med 2005;352:875-883
Earlier Repair Leads to Better
Functional class
Unadjusted Operative Mortality by Preoperative New
York Heart Association (NYHA) Functional Class
NYHA
Repair
Replace
Overall
Class
Mortality (%) Mortality (%) Mortality (%)
I
0.64
2.07
1.09
II
0.87
2.59
1.51
of patients undergoing mitral valve surgery (p
60
45
30
III
1.80
3.71
2.75
15
IV
3.71
7.14
5.66
0
I & II
III & IV
20002001200220032004200520062007
Value of p less than 0.001, test of trend
• Operative mortality for patients undergoing isolated mitral valve
repair for mitral regurgitation was 1.2% (n = 28,140).
• “There was a clear trend of earlier referral of patients with better
functional status over time.”
12. Gammie, James S., et al. Trends in Mitral Valve Surgery in the United States: Results from the Society of Thoracic Surgeons Adult
Cardiac Database. Annals of Thoracic Surgery. 2009; 87: 1431-39.
Calcific Aortic Valve Disease
• Slowly progressive
disorder
• Disease continuum
• Not “wear-and-tear” with
passive calcium
depositing
Severity Indicators
• An active disease
Indicator
Mild
process like
Jet Velocity (m/s)
< 3.0
atherosclerosis:
Mean Gradient (mm Hg)
Valve Area (cm2)
• Lipoprotein
deposition
Valve Area Index (cm /m )
• Chronic inflammation
• Active leaflet calcification
2
7. Bonow,
2
Moderate*
Severe**
3.0 - 4.0
> 4.0
< 25.0
> 1.5
25 – 40
1.0 - 1.5
> 40.0
< 1.0
-
-
< 0.6
*Often Class IIa
**Often Class I or IIb
RO, Carabello, BA, Kanu C, et al. 2008 Focused Update Incorporated Into the ACC/AHA 2006 Guidelines for the Management of
Patients With Valvular Heart Disease. Circulation 2008;118;e523-e661.
2008 Focused Update Incorporated Into the ACC/AHA
2006 Guidelines Timing of Aortic Valve Surgery
Surgery Recommended
Surgery Not
Recommended
Class I
Class IIa
Class IIb should be considered
Class III
AVR is indicated for
symptomatic patients with
severe AS
AVR is reasonable for patients
with moderate AS undergoing
CABG or surgery on the aorta
or other heart valves
AVR may be considered for asymptomatic
patients with severe AS and abnormal response
to exercise (e.g., development of symptoms or
asymptomatic hypotension)
AVR is not useful for the
prevention of sudden death
in asymptomatic patients
with AS who have none of
the findings listed under the
Class IIa/IIb
recommendations
AVR is indicated for patients
with severe AS undergoing
coronary artery bypass graft
surgery
AVR is indicated for patients
with severe AS undergoing
surgery on the aorta or other
heart valves
AVR is recommended for
patients with severe AS and
LV systolic dysfunction
(ejection fraction less than
0.50)
AVR may be considered for adults with severe
asymptomatic AS if there is a high likelihood of
rapid progression (age, calcification, and CAD)
or if surgery might be delayed at the time of
symptom onset
AVR may be considered in patients undergoing
CABG who have mild AS when there is
evidence, such as moderate to severe valve
calcification, that progression may be rapid
AVR may be considered for asymptomatic
patients with extremely severe AS (aortic valve
area less than 0.6 cm2, mean gradient greater
than 60mmHg, and jet velocity greater than 5.0
m per second) when the patient’s expected
operative mortality is 1.0% or less
Aortic
Stenosis
Decision
Diagram
Aortic
Regurgitation
Decision
Diagram
7. Bonow, RO, Carabello, BA, Kanu C, et al. 2008 Focused Update Incorporated Into the ACC/AHA 2006 Guidelines for the Management of Patients
With Valvular Heart Disease. Circulation 2008;118;e523-e661.
Studies Show Patients are
Surgically treated
Untreated
43
54
57
48
60
61
74
57
46
EU
43
52
40
United States
39
26
Bouma 1999
Iung 2003
Pellikka 2005
69
Charlson 2006 Varadarajan 2006
Bach 2007
Jan 2009
31
Freed 2010
4. B J Bouma et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart. 1999;82:143-148.
13. Bernard Iung et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J.
2003;24:1231-1243.
14. Patricia A. Pellikka et
al. Outcome of 622 Adults with Asymptomatic, Hemodynamically Significant Aortic Stenosis During Prolonged Follow-Up. Circ. 2005;111:3290-3295.
15. Erik Charlson et al. Decision-Making and Outcomes in Severe Symptomatic Aortic Stenosis. J Heart Valve Dis. 2006;15:312-321.
16. Padmini Varadarajan et al. Clinical Profile and Natural History of 453 nonsurgically Managed Patients With Severe Aortic Stenosis. Ann Thorac Surg.
2006;82:2111-5.
17. David S. Bach et al. Unoperated Patients With Severe Aortic Stenosis. JACC. 2007;50:2018-2019.
18. Faud Jan et al. Unoperated Patients With Severe Symptomatic Aortic Stenosis. Circ.2009;120:S753.
19. Benjamin H. Freed et al. Reasons for Nonadherence to Guidelines for Aortic Valve Replacement in Patients With Severe Aortic Stenosis and Potential
Solutions. AMJC. 2010;105:1339-1342.
Survival Benefit in Surgically Treated
20. Morgan L. Brown et al. The benefits of early valve replacement in asymptomatic patients with severe aortic stenosis. J Thorac Cardiovasc Surg. 2008
308-315.
Survival Rate of Asymptomatic Patients was
Higher in AVR group vs. Medically Managed
Survival rates of 338 severe asymptomatic patients
100%
75%
50%
AVR patients
Medical patients
25%
0%
Survival Rates Year
Survival
1
Rates Year
Survival
2
Rates Year 5
“Our observational data indicate that the natural history of
asymptomatic AS is not benign and that survival is
dramatically improved by AVR.”
. Ramdas G. Pai et al. Malignant Natural History of Asymptomatic Severe Aortic Stenosis: Benefit of
Aortic Valve Replacement. Ann Thorac Surg. 2006;82:2116-22.
21
Why Refer for Minimal Incision Valve Surgery
(MIVS)?
A decade worth of clinical data demonstrate
that MIVS results can be optimal, if not better
than, open chest valve surgery:
•
•
•
•
•
Less surgical trauma
Reduced blood loss
Better cosmetics
Faster recovery
Greater patient satisfaction
6. Rosengart,
TK, et al. Percutaneous and Minimally Invasive Valve Procedures. A Scientific Statement. Circulation, 2008;117. DOI:10.1161/
CIRCULATIONAHA.107.188525
Type of Surgical Approaches
Hemi or Mini
Sternotomy
Incision
Location
Incision Size6
Visualization
Port Mini
Thoracotomy
Port Mini Thoracotomy:
Robot-Assisted
Sternotomy
Lower Stern.
Hemi- or Ministernotomy
Thoracotomy
Port
Port
[Rib-spreading]
[Non-Rib-Spreading]
(Robot-assisted)
12+ cm
8+ cm
5-8 cm
6-8 cm
4-6 cm
2-4 cm
Direct
Direct
Direct
Direct
Videoscopic
Videoscopic
6. Rosengart, TK, et al. Percutaneous and Minimally Invasive Valve Procedures. A Scientific Statement. Circulation, 2008;117. DOI:10.1161/CIRCULATION
107.188525
Minimal Incision Mitral Valve
Flexibility to reduce
incision size is enabled by:
•
•
•
•
•
•
•
EndoClamp aortic catheter for intra-aortic
occlusion
EndoReturn arterial cannula / EndoDirect
arterial cannula for cannulation
EndoPlege sinus catheter for retrograde
cardioplegia delivery
EndoVent pulmonary catheter for
assisting in decompressing and draining
the heart
QuickDraw venous cannula for venous
drainage
Soft Tissue Retractor to expand and
enabling minimal incisions
Precision Series Instruments with long
shafts to work within smaller incisions
Thoracotomy
Mini-sternotomy
Robotic Mitral Valve repair
Minimal Incision Aortic Valve Replacement
Flexibility to reduce
incision size is enabled by:
•
•
•
•
•
EndoPlege sinus catheter for
retrograde cardioplegia delivery
EndoVent pulmonary catheter Right Anterior Thoracotomy
for assisting in decompressing
and draining the heart
QuickDraw venous cannula for
venous drainage
Soft Tissue Retractor to expand
and enabling minimal incisions
Precision Series Instruments
with long shafts to work within
smaller incisions
Hemi-Sternotomy
Mini AVR
Mini AVR
Minimal Incision Valve Surgery Delivers
Excellent Clinical Outcomes23-26
Provides patients with:
• Excellent clinical outcomes23-25
• Shorter hospital stay24,26
• Quick return to work or routine
activities23
– 71% within 8 weeks
• Significantly less pain than traditional
sternotomy23
• Eliminates median sternotomy and its
associated wound morbidity
• 99% of patients extremely pleased with
cosmetic results23
• 94% of patients would choose the same
procedure23
Provides surgeons with:
• Excellent visualization of
structures
• Clear view of operative
field
• Virtually bloodless
operative field
23. Casselman FP, Slycke SV, Wellens F, De Geest R, Degrieck I, VanPraet F, Vermueulen Y, Vanermen H. Mitral Valve Surgery Can
Now Routinely Be Performed Endoscopically. Circulation. 2003: 108 Suppl 1:II48-54.
24. Grossi E, Galloway AC, Ribicove GH, Zakow PK, Derivaux CC, Baumann FG, Schwesinger DW, Colvin SB. Impact of minimally
invasive valvular heart surgery – a case control study. Ann Thorac Surg. 2001;71:807-810.
25. Glower DD, Siegel LC, Frischmeyer KJ, Galloway AC, Ribakove GH, Robinson NB, Ryan WH, Colvin SB. Predictors of outcome in
a multicenter port-access valve registry. Ann Thorac Surgy. 2000;70:1054-9
Minimal Incision Valve Surgery
Indications
• Indicated
for patients
undergoing
Contraindicati
ons
• Relative
Summary
• Under treatment of valvular disease, based on
ACC/AHA guidelines, remains a relevant issue,
particularly in asymptomatic patients
• Patients with both mitral valve and aortic valve
disease are under-treated in the United States
• Most mitral valves are repairable, and earlier
surgery has better short and long term outcomes
• AVR patients experienced better survival rates
than those who did not receive a procedure.
• Surgical options should be considered for patients
with appropriate need for a procedure
Summary
• Minimal incision valve surgery:
– Provides excellent clinical outcomes
– Allows for significantly smaller incisions and faster
recovery than traditional surgery
– Reduces surgical trauma while equaling or exceeding
the safety and effectiveness of conventional cardiac
surgery
– Is as safe as sternotomy, with shorter hospital stay and
improvement in functional status
– Provides a safe and reproducible approach to CPB and
myocardial protection
– Applicable to the majority of patients and procedures
Minimally Invasive Coronary Bypass
Surgery
• Minimally Invasive Direct Coronary Artery
Bypass MIDCAB
• Single or Multivessel Bypass
• “Small” Left Thoracotomy Incision
– On Pump
• Arrested Heart ( Cross Clamp)
• Beating Heart
– Off Pump
• Sutured or Stapled Anastomosis
Minimally Invasive Coronary Bypass
Surgery
•
•
•
•
•
Robotic Totally Endoscopic Coronary Bypass
TECAB / PortaCAB
Arrested Heart
Off pump Beating Heart
Intuitive Endowrist Stabilizer (Medtronic TE
predecessor) FDA cleared March 2008
• Anastomotic Device (Flexible) FDA cleared
April 2007
CARDICA C-PORT FLEX A




Less-Invasive Distal Anastomosis Device
Remote activation
Sternal sparing
Robotic or non Robotic applications
Harvesting the LIMA through a small
incision MIDCAB
Harvesting the LIMA with the Robot
Robotic T E C A B
Seven days Post OP. Robotic T E C A B
Hybrid Revascularisation
Coronary Bypass Surgery
• Prediction:
“In five years time coronary bypass
will not (should not) be done through a
mediansternotomy”
John Bell-Thomson, MD. MBA