Assessment of Heart Rate Adjusted Mechanical Asynchrony Better Predicts Response to Cardiac Resynchronization Therapy in Heart Failure Patients

The 11th Annual Scientific Meeting stress echocardiography (DSE) and hemodynamics have been used to quantitate myocardial recovery in heart failure(HF) patients supported with LVAD. Here we give our recent experience (since 2000) with assessment of LV recovery and ability to explant LVADs after long term unloading. Objective: Assess utility of DSE and hemodynamics in evaluating recovery of LV function after mechanical unloading with LVAD in patients with end-stage HF. Methods: The study population included 10 patients (8 male, 2 female, age 35 6 18.3) with non-ischemic cardiomyopathy who had undergone LVAD implantation (HeartMate XVE, Jarvik 2000, or HeartMate II devices), regained functional capacity on full LVAD support, and tolerated decreased mechanical support with no worsening of dyspnea or fatigue. All 10 patients underwent DSE with increasing doses of dobutamine (from 5 to 40 mcg/kg/min). Hemodynamics and 2-D echocardiography were performed at each dose level. Different parameters including PCWP, EF, LVDD and degree of mitral regurgitation were recorded. Patients were divided into two groups, favorable and unfavorable based on the results of testing. The favorable patients underwent explantation of their LVADs. Results and Conclusions: There were no significant demographic and echocardiographic differences between the groups before LVAD implantation. Patients in both groups showed a trend in improvement of LV function after one month of LVAD implantation; however, patients in the unfavorable group did not sustain the early improvement. The maximum EF obtained with DSE was recorded for each group. Among the favorable patients ejection fractions at baseline, LVAD off and peak were 29.5, 28.5 and 36.2 respectively. Unfavorable patients had ejection fractions at baseline, LVAD off and peak of 30, 19 and 38 respectively. The echocardiographic and hemodynamic findings correlated with patient outcome after explant. Six patients underwent explantation and all of these had a good long term outcome, though two required later transplantation. In conclusion, LVAD recovery and decision to explant can be assessed with DSE and hemodynamics.



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135 Assessment of Heart Rate Adjusted Mechanical Asynchrony Better Predicts Response to Cardiac Resynchronization Therapy in Heart Failure Patients Asim Rafique1, Tasneem Naqvi1; 1Cedars Sinai Medical Center, Los Angeles, CA Background: Current mechanical asynchrony criteria for predicting response to cardiac resynchronization therapy (CRT) are based on absolute time regardless of cardiac cycle length (RR). Adjusting time to peak (Tp) velocity for RR may better determine response to CRT. Methods: We evaluated 71 pts (67% M, 65 6 16 yr, NYHA class 3.2 6 0.8, 53% ischemic cardiomyopathy (CMP), 42% QRS ! 130 ms, 35% RV pacemaker, 30% A Fib) by tissue Doppler imaging (TDI) pre CRT. Mechanical asynchrony was assessed by published TDI criteria and after adjusting Tp for RR. Mean time to follow up echo was 1 month. Responders (R) were defined as pts with left ventricle (LV) end systolic volume (ESV) reduction of O 15% post CRT. Results: 58% of pts responded to CRT with significant improvement in LV dimension, EF and MR (Table). Pre CRT there was no difference in etiology of CMP, NYHA class, LV EF between R and non-responders (NR). 47% of pts with QRS ! 130 ms, 91% of LBBB, 55% of A Fib, 58% of RV pacemaker pts were R. R had more asynchrony by various criteria (Figure). On logistic regression significant predictor of R was RR adjusted Tp velocity difference in 12 LV segments (TpD) of O 40% (p 5 0.01, OR 5 6 CI 2-23). Sensitivity and specificity of TpD O 40% was 71%, 70% respectively compared with asynchrony index O 33 ms (89%, 28%), septo lateral delay O 60 ms (60%, 52%), septo posterior delay by M Mode O 130 ms (44%, 63%). Conclusion: Adjustment of Tp for RR better predicts response to CRT at 1 month. Pre and Post CRT Echocardiographic Characteristics Responders (N 5 41)

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NYHA Class QRS duration (ms) Pre ESD (cm) Pre LV EF (%) % reduction in LV ESV (%) % improvement in LV EF (%) % reduction in MR Grade

Percutaneous Ventricular Restoration in Chronic Heart Failure Patients (PARACHUTE) e Six Month Followup Peter Otasevic1, Horst Sievert2, Albert Elsasser3, William Abraham4, Michael Dae5; 1 Dedinje Cardiovascular Research, Belgrade, Serbia; 2CardioVascular Center, Frankfurt, Germany; 3Kerckhoff-Klinic, Bad Nauheim, Germany; 4University of Ohio, Columbus, OH; 5UC San Francisco, San Francisco, CA Introduction: One of the most important late complications after myocardial infarction is remodeling of the left ventricle, leading to heart failure. PARACHUTE is a prospective, non-randomized, multicenter, international, first-in-man trial to assess the feasibility of percutaneous catheter mediated ventricular partitioning for treating patients with antetrior apical infarction and congestive heart failure. The goal of the left ventricular partitioning technique is to decrease the End Diastolic Volume of the LV chamber (LVEDV) by partitioning into a dynamic (flow) and a static (no flow) chamber, and to protect remote myocardium from the forces that promote remodeling and progressive dilation of the LV. Methods: A ventricular partition device (VPD) was implanted percutaneously into the apical region of the LV cavity, under fluoroscopy, in 13 patients with symptomatic heart failure, mean age 59.8. One center in Serbia and 2 centers in Germany contributed to the patient cohort. Paired baseline and 6 month LV function (LVEF, LVEDV, LVESV), assessed by echo core lab, along with 6 minute walk, and NYHA class were available in 10/13 patients. Results are shown in the table. Conclusion: This is the first catheter-based system to treat LV enlargement in HF patients with anterior apical infarction. Preliminary data support: 1) the safety of the VPD implant procedure, 2) acute and sustained reductions in LV volumes, and 3) improvement in functional status. An adequately powered randomized controlled trial is needed to confirm these initial observations.

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Serious adverse events consisted of device migration requiring surgical removal in one patient, and one death e not device related.

LVEDV (ml), N 5 10; p ! 0.001 vs 6 months LVESV (ml), N 5 10; p ! .002 vs 6 mos EF (%), N 5 9; p 5 ns vs 6 mos 6 Minute Walk (m), N 5 7; p 5 ns NYHA Class, N 5 10

Baseline Pre Implant (mean 6 sd)

Acute Post Implant (mean 6 sd)

6 Months Post Implant (mean 6 sd)

265 6 51

220 6 58

214 6 37

196 6 50

148 6 43

149 6 32

27 6 8

32 6 9

31 6 6

346 6 130

368 6 119 Improved e 8/10 (80%), Same e 2/10 (20%), Worse e 0/10 (0%)

3.3 146 5.4 30 28 47 58

6 6 6 6 6 6 6

0.8 47 1.1 11 12 50 28

Non Responders (N 5 30)

p Value

6 6 6 6 6 6 6

0.8 0.03 0.3 0.9 !0.001 0.001 !0.001

3.2 127 5.7 30 -6 13 21

0.7 35 0.8 12 24 34 44

Managing Heart Failure Patients with Intra-Thoracic Impedance Monitoring: A Multi-Center US Evaluation Roy Small1, Wilson Tang2, William Wickemeyer3, Robin Germany4, Bobbi Hoppe5, John Andriulli6, Peter Brady7, LaBeau Melody8, Douglas Hettrick8; 1Lancaster Heart; 2Cleveland Clinic; 3Iowa Heart Center; 4University of Oklahoma; 5North Memorial Hospital; 6Cooper Heart Institute; 7Mayo Clinic; 8Medtronic, Inc. Background: Some CRT-D devices also measure intra-thoracic impedance (Z). Changes in Z are used to derive a fluid index (FI) that may cross a programmed threshold value previously shown to reasonably predict worsening heart failure (HF). We examined the clinical utility of device diagnostic data in a US population with Z monitoring but without direct patient alert. Methods: The OFISSER clinical registry included 326 CRT-D (In Sync Sentry, Medtronic) patients (70 6 11yrs, 76%M, EF 5 25 6 8%) from 7 US centers. Clinically relevant events (CRE) including HF hospitalization, symptoms of worsening HF, diuretic changes, and surgical revisions occurring beyond 60 days post implant were identified. Clinicians had access to device data throughout the analysis period. Results: Over 333 6 96 days of follow up, 228 patients (70%) experience 540 FI threshold crossings at the nominal value (60 Udays). Patients with a FI threshold crossing averaged 17 6 12% of days with FI above threshold. Patients with FI values above threshold were significantly