Left Ventricular Functional Recovery after Long-Term Mechanical Unloading with Left Ventricular Assist Device, the Recent Texas Heart Institute Experience

S112 Journal of Cardiac Failure Vol. 13 No. 6 Suppl. 2007 130 Hemodynamics in Patients with a HeartMate II Left Ventricular Assist Device Are Altered with Acute Pump Speed Changes Stuart D. Russell1, MaryAnn Albaugh2, Susan Ullrich2, Heather M. Richardson1, Jessica L. Dossa1, Celine A. Roberts2, John V. Conte2; 1Medicine, Division of Cardiology, Johns Hopkins Hospital, Baltimore, MD; 2Surgery, Johns Hopkins Hospital, Baltimore, MD Background: The HeartMate II (HMII) left ventricular assist device (LVAD) is a new, continuous flow device. Determing the proper speed requires balancing the concerns of inadequate unloading and excessive unloading causing ‘‘septal shift’’ and resultant decrease in function. We evaluated the impact of high and low speeds on acute hemodynamics in patients undergoing right heart cath (RHC) after HMII implantation. Methods: Patients undergoing RHC to evaluate hemodynamics simultaneously underwent echo optimization studies. Baseline hemodynamics were obtained. The pump speed was then decreased until the aortic valve opened with every beat or 8000 rpms. The speed was then increased until septal shift occurred. RHC and echo parameters were obtained at each speed. Results: 16 patients an average of 81 days from implant underwent a total of 23 RHC. The average age was 48, 69% male, 69% idiopathic, EF 13.4%, SBP 95.9, Na 135, and creatinine 1.5. As shown in table, high speeds caused an increase in RV size with no improvement in hemodynamics. Low speeds improved RV size, but were associated with an increase in PCWP, and a decrease in cardiac output. Conclusion: Increasing pump speed until septal shift is associated with acute enlargement of the right ventricle and no significant changes in cardiac output. Conversely, decreasing pump speed is associated with an increase in PCWP and a reduction in cardiac output. Routine echo optimization studies are required to optimize pump speed and hemodynamics with the HMII LVAD.

Figure 1. Kaplan-Meier estimates of survival after LVAD placement (HR: 4.9; 95%CI: 3.5-13, p ! 0.001). ——— Cardiac transplantation ___No cardiac transplantation.

132 Preoperative Risk Factors for Mortality after Biventricular Assist Device Implantation Firas Zahr1, Yoshio Ootaki2, Randall Starling1, Nicholas Smedira3, Mohamad Yamani1, Kiyotaka Fukamachi2; 1Cardiovasvular Medicine, Cleveland Clinic; 2 Biomedical Engineering; 3Cardiac Surgery, Cleveland Clinic

Speed (rpm) Septal shift (%) Aortic v. open (%) RV width (cm) PA sys (mm Hg) PCWP (mm Hg) Cardiac output PA sat (%)

Initial

High

Low

9826 8.7 17.4 4.31 30.4 11.8 5.7 67.2

10,478 91.3 17.4 4.85 33.3 9.6 5.9 67.5

8772 13.0 50.0 4.27 36.4 13.3 5.3 64.0

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A right ventricular assist device (RVAD) is a treatment option for severe right heart failure after left ventricular assist device (LVAD) implantation. Recognitions of risk factors for mortality after biventricular assist implantation are important for patient selection and optimal outcomes. We reviewed our experience in 44 patients who had both LVAD and RVAD support. Thirteen patients (30%) survived until heart transplantation, and 31 patients (70%) died while on support. Survivors and nonsurvivors were supported for 92 6 90 days and 40 6 82 days, respectively. Coagulopathy that required intervention was observed in 32 patients (73%). Neurological defects were observed in 10 patients (23%). Thromboembolic events were observed in 8 patients (18%). There was no significant difference in the rates of these complications between survivors and non-survivors. By univariate analysis, there was no difference in the rates for the need for preoperative support by an intraaortic balloon pumping, ventilator, and extracorporeal membrane oxygenation between survivors and non-survivors. Survivors had significantly less prior surgery and lower creatinine value. Although there were no significant differences, the rates of male gender and primary diagnosis of ischemic cardiomyopathy were higher in non-survivors. Conclusion: Prior cardiac surgery and elevated creatinine were risk factors for mortality after Biventrivular assist devices implantation.

Long-Term Outcomes after the Use of Left Ventricular Assist Devices Santiago Garcia1, Andrew Boyle1, Ranjit John2, Kenneth Lliao2, Lyle Joyce2, Monica Colvin-Adams1; 1Cardiovascular Medicine, University of Minnesota, Minneapolis, MN; 2Cardiovascular Surgery, University of Minnesota, Minneapolis, MN Background: Left ventricular assist devices (LVAD) have been approved for use in selected patients with advanced heart failure. As the experience with the use of LVAD continues to evolve and the mismatch between donors and recipients continues to grow the indications for LVAD have been expanded. In this abstract we report our long-term experience with the use of LVAD. Methods: From October 1998 until June 2006, 136 patients underwent LVAD implantation secondary to class IV congestive heart failure refractory to medical treatment. Long-term mortality was compared between LVAD alone vs. LVAD followed by transplantation. Patients (n 5 10) who died within 30 days of device placement were excluded. Results: Patients (n 5 126) were more likely to be male (81%) and have underlying ischemic heart disease (56%). The mean age at the time of implantation was 55 6 11 years. Cardiac transplantation followed LVAD placement in 61% of patients at a mean time of 222 days (95%CI: 179-266). Long term survival was mainly affected by whether or not cardiac transplantation followed LVAD placement (Fig 1). The survival curves started to diverge early on and remained separated throughout the follow up period (p ! 0.001). The median survival time for LVAD patient was 1.6 years if cardiac transplantation was not performed. Conversely, 73% of LVAD patients were alive at 8 years of follow up if cardiac transplantation was performed. Reasons for not undergoing cardiac transplantation included: 1- myocardial recovery (7 patients), 2- ongoing support or expired while awaiting heart transplantation (39 patients), and ineligibility to heart transplantation (destination therapy, 8 patients). Conclusions: Although the use of LVAD has been expanded from bridge to transplantation to destination therapy and bridge to recovery, cardiac transplantation offers a clear survival advantage in the long term and should follow LVAD placement whenever possible.

Patients characteristics of survirors and non-survivors

Male % Age (y) Ischemic CM % Prior surgery % Delayed RVAD implants % IABP support % Ventilator support % ECMO Support % Total bilirubin (mg/dl) Creatinine (mg/dl)

Survivor

Non-survivor

P value

38 47.8 6 12.7 23 8 31 54 54 23 1.6 6 1.1 1.1 6 0.5

68 51.3 6 13.0 52 39 23 77 77 42 2.6 6 3.3 2.0 6 0.9

0.072 0.411 0.081 0.04 0.604 0.118 0.118 0.235 0.303 0.002

133 Left Ventricular Functional Recovery after Long-Term Mechanical Unloading with Left Ventricular Assist Device, the Recent Texas Heart Institute Experience Reynolds Delgado1, Yazan S. Khouri1, Mitra Rajabi2, Heinrich Taegtmeyer2, Ahmed Abugiazya1, Branislav Radovancevic1, Peggy Odegaard1, O.H. Frazier1; 1Department of Cardiac Transplantation, Texas Heart Institute, Houston, TX; 2Internal Medicine, The University of Texas-Houston, Houston, TX Introduction: Cardiac function may improve in the patients who are supported for a long-term (O 60 days) with left ventricular assist devices (LVADs). Dobutamine

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.



HFSA

S113

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)

134

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.

136

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