Minimally invasive therapies for the mitral valve: How will you incorporate
into your clinical practice?
Guilherme F. Attizzani, MD UH Harrington Heart and Vascular Institute
Interventional Cardiologist/Structural Heart Disease InterventionJohn C. Haugh Valve Fellow
UH Case Medical CenterAssistant Professor of Medicine
Case Western Reserve University School of Medicine
Key Aspects – Mitral Regurgitation
Prevalence is agePrevalence is age--dependent, affecting 9.3% dependent, affecting 9.3% of those aged >75 yearsof those aged >75 years
Etiology is primary (i.e., valvular) or Etiology is primary (i.e., valvular) or secondary (i.e., ventricular)secondary (i.e., ventricular)
Excess mortality occurs from medical Excess mortality occurs from medical management and delays in interventionmanagement and delays in intervention
Surgical risk and etiology determine Surgical risk and etiology determine intervention and its timingintervention and its timing
Nkomo et al. Burden of Valvular Heart Diseases: A Population‐based Study, Lancet, 2006; 368: 1005‐11.Suri R et al., JAMA 2013;310:609‐16Nishimura R, et al., J Am Coll Cardiol 2014;63:2438‐88
Total MR Patients1,2
Eligible for Treatment3,4
(MR Grade ≥3+)
4,100,000
1,700,000
Annual MV Surgery5
Annual Incidence3
(MR Grade ≥3+)250,000
30,000Only 2% Treated Surgically
14% Newly Diagnosed Each Year
1,670,000Untreated Large and Growing Clinical Unmet Need
Untreated Large and Growing Clinical Unmet Need
1. US Census Bureau. Statistical Abstract of the US: 2006, Table 12.2. Nkomo et al. Burden of Valvular Heart Diseases: A Population-based Study, Lancet, 2006; 368: 1005-11.3. Patel et al. Mitral Regurgitation in Patients with Advanced Systolic Heart Failure, J of Cardiac Failure, 2004.4. ACC/AHA 2008 Guidelines for the Management of Patients with Valvular Heart Disease, Circulation: 20085. Gammie, J et al, Trends in Mitral Valve Surgery in the United States: Results from the STS Adult Cardiac Database, Annals of Thoracic Surgery 2010.
A Largely Untreated Patient Population
Mitral Regurgitation 2009 U.S. Prevalence
Flail Mitral Leaflets
Natural History100
80
60
40
20
0
Sur
viva
l %
Years After Diagnosis
0 1 2 3 4 5 6 7 8 9 10
P<0.001
Class I or II
Class III or IV
Mortality4% per year
34% per year
Ling L, et al. N Engl J Med 1996; 335:1417-1423
Hospitalization-free survival decreased with increased MR severity1
100
80
60
40
20
0Hos
pita
lizat
ion-
free
Sur
viva
l (%
)
Years
0 1 2 3 4 5 6 7
P<0.01
No MR(40%)
Severe MR 7%)
Mild/mod MR(25%)
Transplant-free survival decreased with increased MR severity2
100
90
80
70
60
50
40Tr
ansp
lant
-free
Sur
viva
l (%
)
Days
0 500 1000 1500 2000
Grade IV(46.5 ±6.7%)
Grade III(68.5 ±4.6%)
Secondary Mitral RegurgitationSecondary Mitral RegurgitationIncreased Severity = Increased MorbidityIncreased Severity = Increased Morbidity
Grade II(64.4 ±4.9%)
No MR & Grade I(82.7 ±3.1%)
1. Rossi A, Dini FL, Faggiano P, et al. Heart. 2011;97(20):1675-1680.2. Bursi F, Barbieri A, Grigioni F, et al. Eur J Heart Fail. 2010;12(4):382-388.
Medical Management1,095 pts with severe MR and CHF
55‐‐yr mortality for medically managed = 50%yr mortality for medically managed = 50%
DMRDMR
84%
16%
FMRFMR
36%64%
16%
Goel SS, et al. J Am Coll Cardiol 2014;63:185-90
MitraClip Experience
EVEREST IEVEREST I Feasibility (n=55)Feasibility (n=55)
EVEREST IIEVEREST II Pivotal Pivotal PrePre--Randomization (n=60)Randomization (n=60) HR Registry (n= 78)HR Registry (n= 78) Randomized Randomized (2:1 Clip to Surgery) (2:1 Clip to Surgery) (n= 279)(n= 279)
Worldwide Commercial Use: Worldwide Commercial Use: >15,000 patients>15,000 patients
REALISMREALISM RegistryRegistryContinued Access (n=965)Continued Access (n=965)
Prohibitive Surgical Risk DMR Cohort (n=127)
Left Ventricular Volumes
Hospitalizations for Heart Failure
Left Ventricular End Diastolic Volume Left Ventricular End Systolic Volume
(N = 69)PairedData (N=69)
0.67
0.18
0.0
0.2
0.4
0.6
0.8
1.0
1 Year Prior… 1 Year Post…
HF Hospitalization Rate pe
r Pa
tien
t Year
73% Reduction
125
109
60
70
80
90
100
110
120
130
140
Baseline 1 Year
Volu
me
mL
‐16 mL
0 ≈
49
46
30
35
40
45
50
55
60
Baseline 1 Year0 ≈
‐3 mL
0
1+
3+
4+
2+Clinically Important Reduction of Mitral Regurgitation
I
II
IVIIIClinically Important Improvement
in NYHA Functional Class
Clinically Important Reduction in the Rate of Hospitalization
for Heart Failure
Clinically Important Reverse LV Remodeling
Lim et al., JACC 2014;64:182-192.
May be considered for prohibitive risk patients with significant symptomatic
primary mitral regurgitation (MR ≥ 3+) and severe symptoms despite GDMT. Risk should be determined by a heart team that includes
a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced
in mitral valve disease (class IIb)
ACC/AHA Guidelines - MitraClip
Nishimura et al., JACC 2014
Take Home Messages
Patients withPatients with MR ≥ 3+ who are considered to be of prohibitive risk for surgery currently have a percutaneous treatment option.
MitraClip procedure is associated with very MitraClip procedure is associated with very low rates of complications and early, low rates of complications and early, sustained improvement in MR, NYHA sustained improvement in MR, NYHA functional class and QOL.functional class and QOL.
Transesophageal echo is a mandatory Transesophageal echo is a mandatory screening exam to check for procedure screening exam to check for procedure suitability.suitability.