Transcript dolce acuti

Original Article
Biventricular pacing is superior to right
ventricular pacing in bradycardia patients
with preserved systolic function: 2-year results
of the PACE trial
Joseph Yat-Sun Chan, Fang Fang, Qing Zhang, Jeffrey Wing-Hong Fung,
Omar Razali, Hussin Azlan, Kai-Huat Lam, Hamish Chi-Kin Chan,
and Cheuk-Man Yu
Eur Heart J.
2011 Oct;32(20):2533-40.
Epub 2011 Aug 29.
Biventricular Pacing in Patients with
Bradycardia and Normal Ejection
Fraction
Cheuk-Man Yu, M.D., F.R.C.P., Joseph Yat-Sun Chan, F.H.K.A.M., Qing Zhang, M.M.,
Ph.D., Razali Omar, M.D., Gabriel Wai-Kwok Yip, M.D., F.A.C.C., Azlan Hussin, M.D.,
Fang Fang, Ph.D., Kai Huat Lam, M.B., B.S., Hamish Chi-Kin Chan, F.R.C.P., and Jeffrey
Wing-Hong Fung, M.D., F.R.C.P.
N Engl J Med
Volume 361(22):2123-2134
November 26, 2009
Introduction
 Rright ventricular apical pacing (RVA) can, over time,
result in deterioration of left ventricular (LV) function.
• Unexpected increased rates of death and heart failure
admissions among patients who were randomly assigned
DDDR mode in DAVID trial (the Dual Chamber and VVI Implantable Defibrillator)
 RVA pacing continues to be practiced because of its easy
accessibility and relative stability.
Wilkoff BL,et al.2002: JAMA :288:3115-23
Introduction
 Preclinical data: Biventricular pacing (BiV) > RVA to
preserve myocardial performance. (normal EF)
Frias PA et al.2003J Cardiovasc Electrophysiol :14:996-1000.
 Acute hemodynamic study: BiV > RVA to preserve LV
systolic function (normal EF)
.
 Clinical study: BiV > RVA to improve exercise capacity &
quality of life (LV dysfunction)
Lieberman R et al.2006 J Am Coll Cardiol:48:1634-41
Kindermann M et al.2006:J Am Coll Cardiol47:1927-37.
 Underlying mechanism may be
LV systolic dyssynchrony
Cojoc A et al. 2006: J Cardiovasc Electrophysiol17:884-9.
 BiV pacing -a feasible option in patients with normal LV
function as it may attenuate the adverse effect of RVA
pacing on LV systolic function.
Hypothesis & Study Design
 The Pacing to Avoid Cardiac Enlargement (PACE) study
was a prospective, double-blind, randomized, multicenter
clinical trial
 The study done in four centers at China and Malacia from
March 2005 to July 2008.
 Atrial-synchronized BiV pacing is superior to RVA pacing
in preserving LV systolic function & avoiding adverse LV
structural remodeling in patients with standard pacing
indication and normal LV ejection fraction
Inclusion criteria
 Patients with normal LV ejection fraction
(≥45%) who had standard pacing indications
Sinus-node dysfunction
Bradycardia due to advanced AV block
Exclusion criteria
 Persistent atrial fibrillation, ACS
 PCI or CABG <3 months
 Life expectancy of <6 months
 Heart transplant recipients
 Pregnant women
 Patients who fulfilled the eligibility criteria but, implantation
of a BiV system was unsuccessful were also excluded
Study Design
 Patients received an atrial-synchronized BiV pacemaker
capable of delivering RVA pacing or BiV pacing
 The RA and RV leads were positioned at the RA appendage
and the RV apex and LV lead - posterolateral or lateral
branches of the coronary sinus.
 Two days after implantation, patients were stratified
according to normal or abnormal LV diastolic function
 Patients in each group were randomly assigned to receive
BiV pacing or RVA pacing, and their pacemakers were
programmed accordingly.
Study flowchart
Recruitment
Randomization
251 Were screened for
pacemaker therapy
Follow up
88 received
RVA pacing
(97% RVA
pacing)
177 underwent
randomization
Excluded:
inadequate image
quality (7), ejection
fraction<45% (6)
238 Fulfilled the study
inclusion criteria
67 Had normal
diastolic function
110 Had diastolic
dysfunction
81completed
2-yr follow up
45 declined
participation
193 Underwent device
implantation
4 died, 3
declined
follow up
RVA pacing
(n=33)
Biv pacing
(n=34)
RVA pacing
(n=55)
89 received
BiV pacing
(98% BiV
pacing)
3died, 3
declined
follow up
82 completed
2-yr follow up
(1 -inadequate
image quality)
BiV pacing
(n=55)
14 patients had a high LV lead pacing threshold (.5 V) and 2 patients had dissection of the coronary sinus without further
clinical complications. These 16 patients received conventional dual-chamber pacing and were not included for randomization
2 patients in the BiV pacing group experienced diaphragmatic stimulation and were crossed over to the RVA pacing group at 1
and 7 months, and 1 patient from the RVA group was crossed over to BiV because of heart failure and significant LV
dysfunction at 14 month
Study End-points
 Primary End-points
LV ejection fraction at 12 months
LV end-systolic volume at 12 months
Real-time 3D echocardiography in 90% of the patients, Biplane Simpson’s method in 10%
 Secondary End-points
LV end-diastolic volume
6-min hall walk distance
Quality of life scores (SF-36 health survey questionnaire)
For the present 2-year extended follow-up study, all enrolled patients were followed up at 18 and 24 months
.
Statistical Analysis
 Sample size calculation
Estimated on the basis of the postulated difference in LVEF of
5% between the 2 pacing groups at 12 months (PASS 2000
software,NCSS)
Sample size for the study was 170 patients
 Statistical analysis on end-points
Intention-to-treat: patients with ≥3 months follow up were
included
Analysis was also performed based on final pacing sites
Two-sided t-test or non-parametric test: for differences in endpoints
General Liner Model: potential interaction of clinical factors on
primary end-points
Baseline Characteristics
Parameters
RVA pacing (n=88)
BiV pacing (n=89)
P value
Age – years
68±11
69±11
0.76
Male sex – no. (%)
49 (56)
47 (53)
0.70
Systolic blood pressure – mmHg
143±22
148±24
0.14
Diastolic blood pressure – mmHg
69±12
73±12
0.01
Heart rate – bpm
59±18
59±17
0.98
QRS duration – ms
107±30
107±27
0.98
Left ventricular ejection fraction – %
61.5±6.6
61.9±6.7
0.86
Dyssynchrony Index – ms
12.4±8.1
14.0±10.6
0.43
Indication for pacing – no. (%)
0.24
Advanced atrioventricular block
55 (63)
49 (55)
Sinus node dysfunction
33 (37)
40 (45)
Hypertension
55 (62)
62 (70)
0.24
Diabetes mellitus
26 (29)
23 (26)
0.70
Coronary heart disease
20 (23)
19 (21)
0.71
Heart failure
12 (14)
10 (11)
0.63
4 (5)
2 (2)
0.44
Medical history – no. (%)
Chronic renal failure
Comparison of Primary End-points
BiV pacing
*P<0.001 vs RVA pacing
Absolute difference of EF by 10%
RVA pacing
*P<0.001 vs RVA pacing
Absolute difference of LVESV by 13 ml
Comparison of Secondary End-points
Subgroup Analysis – LV Ejection Fraction
Subgroup Analysis – LV End-Systolic Volume
Major findings in the study
 LV ejection fraction reduced by 13% in the second year of RVA pacing
 Eighteen patients in the BiV pacing gp. (20.2%) and 55 in the RVA
gp. (62.5%) had a significant reduction of LVEF (of ≥5%, P , 0.001)
 Both patients with normal and abnormal baseline LV diastolic function
benefited from BiV pacing
 No difference in 6-min walk or quality of life between RVA and BiV
pacing
Study limitations
 Small sample size, not powered at any difference in clinical
events
 Lower success rate for BiV pacing (92%) than conventional
dual chamber pacing
 A longer follow-up period is desirable to examine the
progressive change in LVESV over time.
Conclusion
The PACE study
• The first randomized, controlled study showing that In
patients with normal systolic function, conventional
right ventricular apical pacing resulted in adverse left
ventricular remodeling and in a reduction in the left
ventricular
ejection
fraction;
prevented by biventricular pacing.
these
effects
were
Original Article
Benefit of Early Statin Therapy in Patients
With Acute Myocardial Infarction Who Have
Extremely Low Low-Density Lipoprotein
Cholesterol
Ki Hong Lee, Myung Ho Jeong, Ha Mi Kim RN, Youngkeun Ahn,Jong Hyun Kim,Shung
Chull Chae,Young Jo Kim,Seung Ho Hur, In Whan Seong,Taek Jong Hong,Dong Hoon
Choi,Myeong Chan Cho,Chong Jin Kim,
Ki Bae Seung,Wook Sung Chung,Yang Soo Jang, Seung Woon Rha,Jang Ho Bae, Jeong
Gwan Cho and Seung Jung Park,
J Am Coll Cardiol
2011;Nov.58:1664–71.
Introduction
 Physicians often encounter patients with ACS with LDL-C levels
below 70 mg/dl
 PROVE IT–TIMI 22 trial revealed no benefit in patients with
baseline LDL-C ≥66 mg/dl
 Several studies reported that statin therapy resulted in favorable
outcomes regardless of baseline LDL-C levels
 The influence of baseline LDL-C on the clinical benefit of lipidlowering therapy remains controversial.
 This study investigated whether statin therapy could be beneficial in
AMI patients with a baseline LDL-C levels below 70 mg/dl.
Study Design
 Analyzed 1,054 patients with AMI who had baseline LDL-C
levels below 70 mg/dl and survived at discharge from the
Korean Acute MI Registry between Nov. 2005 and Dec. 2007.
 They were divided into 2 groups according to the prescribing
of statins at discharge (statin gp. n 607; nonstatin gp. n 447)
 The primary endpoint was the composite of 1-yr. MACE,
including death, recurrent MI, target vessel revascularization,
and CABG
Baseline Characteristics
Estimates of the Rate of the Primary
Endpoint Events
Clinical outcomes at 6 and 12 Months
according to statin medication
Conclusion
 Statin therapy in patients with AMI with
LDL-C levels below 70 mg/dl was
associated with improved clinical outcome
 Statin therapy significantly reduced the
risk of the composite of the MACE, mainly
driven by the risk reduction in cardiac
death and coronary revascularization.
Original Article
Effects of Hydration in Contrast-Induced Acute
Kidney Injury After Primary Angioplasty : A
Randomized, Controlled Trial
Mauro Maioli, Anna Toso,Mario Leoncini,
Carlo Micheletti and Francesco Bellandi
Circ Cardiovasc Interv.
2011;Oct.4:456-462.
Introduction
 Intravascular volume expansion is a beneficial measure
against contrast-induced acute kidney injury (CI-AKI) in
patients undergoing elective angiographic procedures.
 Efficacy of this has not yet been established for patients
with STEMI, who are at higher risk of CI-AKI after
primary PCI.
 This study investigated the possible beneficial role of
periprocedural intravenous volume expansion in patients
with STEMI undergoing primary PCI.
Study Design
 Prospective, randomized , 3-arm,single centre study
at Misericordia e Dolce Hospital, Prato, Italy.
 July 2004 to Dec. 2008, all consecutive patients
with STEMI who were candidates for primary PCI
• Randomly assigned to 3 groups
preprocedure and postprocedure hydration of sodium
bicarbonate (early hydration group)
 postprocedure hydration of isotonic saline (late hydration
group)
No hydration (control group)
Study flowchart
Baseline Characteristics
End Points of the Study, Incidence of CI-AKI in HighRisk Patients, and In-Hospital Outcomes in
the 3 Study Groups
*Early hydration versus control group, P0.001 (Bonferroni correction).
†Early versus late hydration group, P0.015 (Bonferroni correction).
Conclusion
 Adequate intravenous volume expansion may prevent CIAKI in patients undergoing primary PCI.
 A regimen of preprocedure and postprocedure hydration
therapy with sodium bicarbonate appears to be more
efficacious than postprocedure hydration only with isotonic
saline.