Continuously Updated Estimation of Heart Transplant Waitlist Mortality.

BACKGROUND: Heart transplant allocation in the United States is made on the basis of coarse tiers, defined by mechanical circulatory devices and therapy for advanced heart failure, updated infrequently as a patient's condition deteriorates. Thus, many patients die awaiting heart transplantation. What is needed is a tool that continuously updates risk of mortality as a patient's condition changes to inform clinical decision making. OBJECTIVES: This study sought to develop a decision aid that aggregates adverse events and measures of end-organ function into a continuously updated waitlist mortality estimate. METHODS: From 2008 to 2013, 414 patients were listed for heart transplantation at Cleveland Clinic, Cleveland, Ohio. The endpoint was waitlist death. Pre-listing patient characteristics and events and laboratory results during listing were analyzed. At each event or measurement change, mortality was recomputed from the resulting model. RESULTS: There were 77 waitlist deaths, with 1- and 4-year survival of 85% and 57%, respectively. When time-varying events and measurements were incorporated into a mortality model, pre-listing patient characteristics became nonsignificant. Neurological events (hazard ratio [HR]: 13.5; 95% confidence interval [CI]: 7.63 to 23.8), new requirement for dialysis (HR: 3.67; 95% CI: 1.88 to 7.14), more respiratory complications (HR: 1.79 per episode; 95% CI: 1.23 to 2.59), and higher serum bilirubin (p < 0.0001) and creatinine (p < 0.0001) yielded continuously updated estimates of patient-specific mortality across the waitlist period. CONCLUSIONS: Mortality risk for patients with advanced heart failure who are listed for transplantation is related to adverse events and end-organ dysfunction that change over time. A continuously updated mortality estimate, combined with clinical evaluation, may inform status changes that could reduce mortality on the heart transplant waiting list.

Optimal Timing of Heart Transplant After HeartMate II Left Ventricular Assist Device Implantation.

BACKGROUND: Optimal timing of heart transplantation in patients supported with second-generation left ventricular assist devices (LVADs) is unknown. Despite this, patients with LVADs continue to receive priority on the heart transplant waiting list. Our objective was to determine the optimal timing of transplantation for patients bridged with continuous-flow LVADs. METHODS: A total of 301 HeartMate II LVADs (Thoratec Corp, Pleasanton, CA) were implanted in 285 patients from October 2004 to June 2013, and 86 patients underwent transplantation through the end of follow-up. Optimal transplantation timing was the product of surviving on LVAD support and surviving transplant. RESULTS: Three-year survival after both HeartMate II implantation and heart transplantation was unchanged when transplantation occurred within 9 months of implantation. Survival decreased as the duration of support exceeded this. Preoperative risk factors for death on HeartMate II support were prior valve operation, prior coronary artery bypass grafting, low albumin, low glomerular filtration rate, higher mean arterial pressure, hypertension, and earlier date of implant. Survival for patients without these risk factors was lowest when transplant was performed within 3 months but was relatively constant with increased duration of support. Longer duration of support was associated with poorer survival for patients with many of these risk factors. Device reimplantation, intracranial hemorrhage, and postimplant dialysis during HeartMate II support were associated with decreased survival. CONCLUSIONS: Survival of patients supported by the HeartMate II is affected by preoperative comorbidities and postoperative complications. Transplantation before complications is imperative in optimizing survival.

Mechanical circulatory support for heart failure: past, present and a look at the future.

Heart transplantation remains the gold standard for long-term cardiac replacement, but a shortage of donor organs will always limit this option. For both transplant-eligible and noneligible patients, advances in mechanical circulatory support have revolutionized the options for the management of end-stage heart failure, and this technology continues to bring us closer to a true alternative to heart transplantation. This review provides a perspective on the past, present and future of mechanical circulatory support and addresses the changes in technology, patient selection and management strategies needed to have this therapy fully embraced by the heart failure community, and perhaps replace heart transplantation either as the therapy of choice or as a strategy by which to delay transplantation in younger patients.

Axial and centrifugal continuous-flow rotary pumps: a translation from pump mechanics to clinical practice.

The recent success of continuous-flow circulatory support devices has led to the growing acceptance of these devices as a viable therapeutic option for end-stage heart failure patients who are not responsive to current pharmacologic and electrophysiologic therapies. This article defines and clarifies the major classification of these pumps as axial or centrifugal continuous-flow devices by discussing the difference in their inherent mechanics and describing how these features translate clinically to pump selection and patient management issues. Axial vs centrifugal pump and bearing design, theory of operation, hydrodynamic performance, and current vs flow relationships are discussed. A review of axial vs centrifugal physiology, pre-load and after-load sensitivity, flow pulsatility, and issues related to automatic physiologic control and suction prevention algorithms is offered. Reliability and biocompatibility of the two types of pumps are reviewed from the perspectives of mechanical wear, implant life, hemolysis, and pump deposition. Finally, a glimpse into the future of continuous-flow technologies is presented.

Unplanned hospital readmissions after HeartMate II implantation: frequency, risk factors, and impact on resource use and survival.

OBJECTIVES: The purpose of this study was to identify potential areas for quality improvement and cost containment. We investigated readmissions after HeartMate II left ventricular assist device (LVAD) implantation by characterizing their type, temporal frequency, causative factors, and resource use and survival after readmission. BACKGROUND: The HeartMate II LVAD provides enhanced survival and quality of life to end-stage heart failure patients. Whether these improved outcomes are accompanied by a similar reduction in unplanned hospital readmissions is largely unknown. METHODS: From October 2004 to January 2010, 118 patients received a HeartMate II, of whom 92 were discharged on device support. Subsequent readmissions were analyzed using prospectively maintained clinical and financial databases. RESULTS: Forty-eight patients (52%) had 177 unplanned hospital readmissions, 87 non-LVAD- and 90 LVAD-associated. Reasons for non-LVAD-associated readmissions included medical management of comorbidities and progression of cardiac pathology (n = 48), neuropsychiatric/psychosocial issues (n = 22), and infections (n = 17). Those for LVAD-associated readmissions included device component infection (n = 51), management of nontherapeutic anticoagulation or device malfunction (n = 22), and bleeding (n = 15). Cumulative incidence of unplanned readmissions was higher (p < 0.0001) for destination therapy than bridge-to-transplant patients (9/patient vs. 4/patient at 24 months). Cumulative hospital days overall were 25 and 42 at 12 and 18 months, respectively, and the costs were 18% and 29% of initial implantation costs. Increased number of unplanned readmissions was predictive of mortality. CONCLUSIONS: Unplanned readmissions are common during HeartMate II support and negatively affect resource use and survival. Refining patient selection, especially in destination therapy patients, reducing infectious and bleeding complications, and increasing awareness about these devices might reduce unnecessary readmissions.

Cardiac transplantation and mechanical circulatory support at Cleveland Clinic.

The cardiac transplantation program at Cleveland Clinic has performed 1,627 adult orthotopic heart transplants, with a current 1-year survival of 96% and a 3-year survival of 82%. The change in the heart allocation system in 2006 has affected our Center by both reducing the number of transplants we perform annually and increasing the percentage of recipients on MCS at the time of transplant. Despite the increased utilization of left ventricular assist devices (LVADs) as a bridge to transplant, we continue to maintain excellent outcomes. The major clinical advances in LVAD technology have allowed us to expand this therapy to ineligible transplant patients, with outcomes that are continually improving. Nevertheless, the field of MCS as permanent therapy is still in its infancy. The number of patients who can benefit from this technology in the U.S. alone is in the thousands, but refinements in patient selection and management are needed to further advance this lifesaving therapy.

Bridge to transplant experience: factors influencing survival to and after cardiac transplant.

OBJECTIVE: Balancing longer duration of mechanical circulatory support while awaiting functional recovery against the increased risk of adverse events with each day on support is difficult. Therefore, we investigated the complex interplay of duration of mechanical circulatory support and patient and device factors affecting survival on support, as well as survival after transplantation. METHODS: From December 21, 1991, to July 1, 2006, mechanical circulatory support was used in 375 patients as a bridge to transplantation, with 262 surviving to transplant. Implantable pulsatile devices were used in 321 patients, continuous flow was used in 11 patients, a total artificial heart was used in 5 patients, external pulsatile devices were used in 34 patients, and extracorporeal membrane oxygenation was used in 68 patients. Two time-related models were developed: (1) a competing-risks multivariable model of death on mechanical circulatory support, with modulated renewal for each sequential support mode; and (2) a model of death after transplant in which patient factors and duration of mechanical circulatory support were investigated as risk factors. RESULTS: Survival after initiating mechanical circulatory support, irrespective of transplantation, was 86% at 30 days, 55% at 5 years, and 41% at 10 years; survival was 94%, 74%, and 58% at the same time intervals, respectively, after transplantation in those surviving the procedure. Risk factors for death included longer, but not shorter, duration of mechanical circulatory support, use of multiple devices, global sensitization, and poor renal function. CONCLUSION: Initiating mechanical circulatory support early with a single definitive device may improve survival to and after cardiac transplantation. Early transplant, which avoids infection, sensitization, and neurologic complications, may improve bridge and transplant survival.

Decision support in surgical management of ischemic cardiomyopathy.

OBJECTIVES: The surgical approach to ischemic cardiomyopathy maximizing survival remains a dilemma, with decisions complicated by secondary mitral regurgitation, ventricular remodeling, and heart failure. As a component of decision support, we sought to develop prediction models for comparing survival after coronary artery bypass grafting alone, coronary artery bypass grafting plus mitral valve anuloplasty, coronary artery bypass grafting plus surgical ventricular restoration, and listing for cardiac transplantation. METHODS: From 1997 to 2007, 1468 patients with ischemic cardiomyopathy (ejection fraction <30%) underwent coronary artery bypass grafting alone (n = 386), coronary artery bypass grafting plus mitral valve anuloplasty (n = 212), coronary artery bypass grafting plus surgical ventricular restoration (n = 360), or listing for cardiac transplantation (n = 510). Mean follow-up was 3.8 +/- 2.8 years, with 5577 patient-years of data available for analysis. Risk factors were identified for early and late mortality by using 80% training and 20% validation sets. Outcomes were calculated for each applicable strategy to identify which maximized predicted 5-year survival. Models were programmed as a strategic decision-support tool. RESULTS: One-, 5-, and 9-year survival were as follows, respectively: coronary artery bypass grafting, 92%, 72%, and 53%; coronary artery bypass grafting plus mitral valve anuloplasty, 88%, 57%, and 34%; coronary artery bypass grafting plus surgical ventricular restoration, 94%, 76%, and 55%; and listing for cardiac transplantation, 79%, 66%, and 54%. Risk factors included older age, higher New York Heart Association class, lower ejection fraction, longer interval from myocardial infarction to operation, and numerous comorbidities. Predicted and observed survivals in validation groups were similar (P > .1). Patient-specific simultaneous solutions of applicable models revealed therapy potentially providing maximum survival benefit. Coronary artery bypass grafting alone and listing for cardiac transplantation often maximized 5-year survival; only 15% of patients undergoing coronary artery bypass grafting plus mitral valve anuloplasty were predicted to fare best with this therapy. CONCLUSION: Validated prediction models can aid surgeons in recommending personalized treatment plans that maximize short- and long-term survival for ischemic cardiomyopathy.

Prognosis of patients removed from a transplant waiting list for medical improvement: implications for organ allocation and transplantation for status 2 patients.

OBJECTIVES: To address the present controversy regarding optimal management of status 2 heart transplant candidates, we studied the short- and long-term fate of medically improved patients removed from our transplant waiting list to assess return of heart failure and occurrence of sudden cardiac death, identify interventions to improve outcomes, and compare their survival with that of similar transplanted patients. METHODS: From January 1985 to February 2004, 100 status 2 patients were delisted for medical improvement (median on-list duration, 314 days). Return of heart failure, sudden cardiac death, and all-cause mortality were determined from follow-up (mean, 7.7 +/- 3.9 years among survivors; 10% followed >12 years). Hazard function modeling, competing-risks analyses, simulation, and propensity matching to equivalent patients undergoing transplantation were used to analyze and compare outcomes and predict benefit of interventions. RESULTS: Freedom from return of heart failure was 77% at 5 years. The most common mode of death was sudden cardiac death, with risk peaking at 2.5 years after delisting but remaining at 3.5% per year thereafter. Event-free survival at 1, 5, and 10 years was 94%, 55%, and 28%, respectively; simulation demonstrated that implantable cardioverter-defibrillators could have improved this to 45% at 10 years. Overall survival after delisting was better than that of matched status 2 patients who underwent transplantation, but was demonstrably worse after 30 months. CONCLUSIONS: Status 2 patients, including those delisted, require vigilant surveillance and optimal medical management, implantable cardioverter-defibrillators, and a revised approach to transplantation timing, such that overall salvage is maximized while allocation of scarce organs is optimized.

Percutaneous and minimally invasive valve procedures: a scientific statement from the American Heart Association Council on Cardiovascular Surgery and Anesthesia, Council on Clinical Cardiology, Functional Genomics and Translational Biology Interdisciplinary Working Group, and Quality of Care and Outcomes Research Interdisciplinary Working Group.

The incidence of valvular heart disease is expected to increase over the next several decades as a large proportion of the US demographic advances into the later decades of life. At the same time, the next several years can be anticipated to bring a broad transition of surgical therapy to minimally invasive (minithoracotomy and small port) access and the more gradual introduction of percutaneous approaches for the correction of valvular heart disease. Broad acceptance of these technologies will require careful and sometimes perplexing comparisons of the outcomes of these new technologies with existing standards of care. The validation of percutaneous techniques, in particular, will require the collaboration of cardiologists and cardiac surgeons in centers with excellent surgical and catheter experience and a commitment to trial participation. For the near term, percutaneous techniques will likely remain investigational and will be limited in use to patients considered to be high risk or to inoperable surgical candidates. Although current-generation devices and techniques require significant modification before widespread clinical use can be adopted, it must be expected that less invasive and even percutaneous valve therapies will likely have a major impact on the management of patients with valvular heart disease over the next several years.

Improved outcomes after aortic valve surgery for chronic aortic regurgitation with severe left ventricular dysfunction.

OBJECTIVES: Among patients undergoing aortic valve surgery for chronic aortic regurgitation (AR), we sought to: 1) compare survival among those with and without severe left ventricular dysfunction (LVD); 2) identify risk factors for death, including LVD and date of operation; and 3) estimate contemporary risk for cardiomyopathic patients. BACKGROUND: Patients with chronic AR and severe LVD have been considered high risk for aortic valve surgery, with limited prognosis. Transplantation is considered for some. METHODS: From 1972 to 1999, 724 patients underwent surgery for chronic AR; 88 (12%) had severe LVD. They were propensity matched to patients with nonsevere LVD to compare hospital mortality, interaction of operative date with severity of LVD, and late survival. Propensity score-adjusted multivariable analysis was performed for all 724 patients to identify risk factors for death. RESULTS: Survival was lower (p = 0.04) among patients with severe LVD than among matched patients with nonsevere LVD (30-day, 1-, 5-, and 25-year survival estimates were 91% vs. 96%, 81% vs. 92%, 68% vs. 81%, and 5% vs. 12%, respectively). However, survival of patients with severe LVD improved dramatically across the study time frame (p = 0.0004): hospital mortality decreased from 50% in 1975 to 0% after 1985, and time-related survival in patients with severe LVD operated on since 1985 became equivalent to that of matched patients with nonsevere LVD (p = 0.96). CONCLUSIONS: Neutralizing risk of severe LVD has improved early and late survival such that aortic valve surgery for chronic AR and cardiomyopathy is no longer a high-risk procedure for which transplantation is the best option.

Duration of inotropic support after left ventricular assist device implantation: risk factors and impact on outcome.

OBJECTIVES: Because duration of inotropic support after left ventricular assist device implantation has been recognized as a surrogate for right ventricular dysfunction, we sought to (1) identify its preimplantation risk factors, particularly its association with preimplantation right ventricular dysfunction, and (2) assess its impact on clinical outcomes. METHODS: Between 1991 and 2002, left ventricular assist devices were implanted in 207 patients, exclusive of those receiving preoperative mechanical circulatory support, which precluded measuring right ventricular stroke work. Duration of inotropic support was analyzed as a continuous variable, truncated by death or transplantation, and in turn as a risk factor for these 2 events. RESULTS: Inotropic support decreased from 100% on the day of implantation to 57%, 33%, and 22% by days 7, 14, and 21. Its duration was strongly associated with lower preimplantation right ventricular stroke work index, older age, and nonischemic cardiomyopathy and was associated (P < .04) with higher mortality before transplantation but not with transition to transplantation. We identified no preimplantation risk factors for right ventricular assist device use because of its relatively infrequent use in this population (18 patients, only 4 of whom survived to transplantation). CONCLUSION: Duration of inotropic support after left ventricular assist device insertion is strongly correlated with low preimplantation right ventricular stroke work index. In turn, it was associated with reduced survival to transplantation. Thus, right ventricular stroke work measured before implantation might be useful in decision making for biventricular support, destination therapy, or total artificial heart.

Neurohormonal response to left ventricular reconstruction surgery in ischemic cardiomyopathy.

OBJECTIVES: Activation of the neuroendocrine axis in congestive heart failure is of prognostic significance, and neurohumoral blocking therapy prolongs survival. The hypothesis that surgical reduction of left ventricular size and function decreases neuroendocrine activation is less established. We evaluated the neurohormonal response to left ventricular reconstruction surgery in ischemic cardiomyopathy. METHODS: Norepinephrine, plasma renin activity, and angiotensin II were measured in 10 patients before and 12 months after left ventricular reconstruction. In an additional 5 patients, brain natriuretric peptide was measured before and 3 months postoperatively. Three-dimensional cardiovascular imaging was used to assess ejection fraction and left ventricular end-diastolic volume index. RESULTS: Concurrent with improvements of New York Heart Association functional class (2.9 +/- 0.5 preoperatively vs 2.0 +/- 0.4 postoperatively, P <.001), ejection fraction (23.9% +/- 6.6% vs 36.2% +/- 6.2%, P <.01), and left ventricular end-diastolic volume index (140.8 +/- 33.8 mL/m(2) vs 90.6 +/- 18.3 mL/m(2), P <.01), considerable reductions were observed for median plasma profiles of norepinephrine (562.0 pg/mL vs 319.0 pg/mL, P <.05), plasma renin activity (5.75 microg/L/h vs 3.45 microg/L/h, P <.05), angiotensin II (41.0 ng/mL vs 23.0 ng/mL, P =.051), and brain natriuretric peptide (771.0 pg/mL vs 266.0 pg/mL, P <.05). The more plasma renin activity or angiotensin II decreased after left ventricular reconstruction, the higher was the increase in ejection fraction (R = -.745, P <.05 [plasma renin activity]; R = -.808, P <.05 [angiotensin II]). CONCLUSIONS: Surgical improvements of ejection fraction and left ventricular end-diastolic volume index by left ventricular reconstruction were accompanied by improvement of both the neuroendocrine activity and the functional status in patients with congestive heart failure. Whether this favorable neurohormonal response is predictive of an improved survival requires further evaluation.

Tricuspid valve repair: durability and risk factors for failure.

OBJECTIVES: To compare durability of tricuspid valve annuloplasty techniques, identify risk factors for repair failure, and characterize survival, reoperation, and functional class of surviving patients. METHODS: From 1990 to 1999, 790 patients (mean age 65 +/- 12 years, 51% New York Heart Association functional class III or IV, and mean right ventricular systolic pressure 56 +/- 18 mm Hg) underwent tricuspid valve annuloplasty for functional regurgitation using 4 techniques: Carpentier-Edwards semi-rigid ring, Cosgrove-Edwards flexible band, De Vega procedure, and customized semicircular Peri-Guard annuloplasty. Of these patients, 89% had concomitant mitral valve surgery. A total of 2245 follow-up transthoracic echocardiograms were retrieved. Tricuspid regurgitation was analyzed, and risk factors for worsening regurgitation were identified, by multivariable ordinal longitudinal methods. RESULTS: Tricuspid regurgitation 1 week after annuloplasty was 3+ or 4+ in 14% of patients. Regurgitation severity was stable across time with the Carpentier-Edwards ring (P =.7), increased slowly with the Cosgrove-Edwards band (P =.05), and rose more rapidly with the De Vega (P =.002) and Peri-Guard (P =.0009) procedures. Risk factors for worsening regurgitation included higher preoperative regurgitation grade, poor left ventricular function, permanent pacemaker, and repair type other than ring annuloplasty. Right ventricular systolic pressure, ring size, preoperative New York Heart Association functional class, and concomitant surgery were not risk factors. Tricuspid reoperation was rare (3% at 8 years), and hospital mortality after reoperation was 37%. CONCLUSIONS: Tricuspid valve annuloplasty did not consistently eliminate functional regurgitation, and across time regurgitation increased importantly after Peri-Guard and De Vega annuloplasties. Therefore, these repair techniques should be abandoned, and transtricuspid pacing leads should be replaced with epicardial leads.

Ventricular reconstruction surgery for congestive heart failure.

The significant increase in the prevalence of heart failure in the United States has made this disease a major health problem. The continued shortage of donor organs has prevented heart transplantation from becoming an effective solution for the treatment of end-stage heart failure, and as a result, surgical treatments for heart failure have been reexamined. Surgical therapies represent the evolution of conventional operations, such as coronary artery bypass surgery, and the application of the more novel left ventricular (LV) reconstruction operations which address the geometry of the LV, the important component in the failing heart.

Evolving strategies for surgical management of patients with severe left ventricular dysfunction.

As a result of an increasing population with advanced congestive heart failure and the lack of growth in cardiac transplantation, surgical treatments for heart failure have been re-examined. These therapies represent the evolution of well-known operations such as coronary bypass surgery and valve surgeries, and the more novel left ventricular reconstruction and operations aimed at inhibiting left ventricular remodeling. When performed by surgeons with experience in this evolving speciality within cardiovascular surgery, surgery for advanced heart failure is a treatment of choice for many patients.

Cardiac transplantation at the Cleveland Clinic.

The cardiac transplant program at the Cleveland Clinic began in 1984 and has performed nearly 1,100 heart transplants. One-year actual graft and patient survival was 88% among 185 adult recipients transplanted between 1997-1999. In the past 20 years, we have seen a significant evolution of recipient selection criteria, donor suitability, immunosuppressive therapies, and posttransplant patient surveillance. Many of the changes in our program are a result of the bleak forecast, that even in a utopian situation, there would be an inadequate supply of donors. Since the potential growth in transplantable organs appears to be finite, every mechanism possible should be utilized to decrease the demand for this scarce resource. It is of utmost importance that all medical and surgical options have been exhausted prior to listing a patient for transplantation. More than 90% of our transplants are performed in patients who are UNOS Status 1A or 1B. Every patient on the waiting list must be reviewed periodically, to ensure that transplantation is still the most viable option. Finally, to reduce the risk of rejection and preserve graft survival, we must continue the search for novel immunosuppressants.

Predictors of severe right ventricular failure after implantable left ventricular assist device insertion: analysis of 245 patients.

BACKGROUND: Insertion of an implantable left ventricular assist device (LVAD) complicated by early right ventricular (RV) failure has a poor prognosis and is largely unpredictable. Prediction of RV failure after LVAD placement would lead to more precise patient selection and optimal device selection. METHODS AND RESULTS: We reviewed data from 245 patients (mean age, 54+/-11 years; 85% male) with 189 HeartMate (77%) and 56 Novacor (23%) LVADs. Ischemic cardiomyopathy predominated (65%), and 29% had dilated cardiomyopathy. Overall, RV assist device (RVAD) support was required after LVAD insertion for 23 patients (9%). We compared clinical and hemodynamic parameters before LVAD insertion between RVAD (n=23) and No-RVAD patients (n=222) to determine preoperative risk factors for severe RV failure. By univariate analysis, female gender, small body surface area, nonischemic etiology, preoperative mechanical ventilation, circulatory support before LVAD insertion, low mean and diastolic pulmonary artery pressures (PAPs), low RV stroke work (RVSW), and low RVSW index (RVSWI) were significantly associated with RVAD use. Elevated PAP and pulmonary vascular resistance were not risk factors. Risk factors by multivariable logistic regression were preoperative circulatory support (odds ratio [OR], 5.3), female gender (OR, 4.5), and nonischemic etiology (OR, 3.3). CONCLUSIONS: The need for circulatory support, female gender, and nonischemic etiology were the most significant predictors for RVAD use after LVAD insertion. Regarding hemodynamics, low PAP and low RVSWI, reflecting low RV contractility, were important parameters. This information may lead to better patient selection for isolated LVAD implantation.

Left ventricular splints and wraps for end-stage heart failure: a new approach in the new millennium.

The epidemic of heart failure and its subsequent effect on public health policy is escalating. Cardiac transplantation continues to be limited by the shortage of donor organs, and the current generation of mechanical circulatory support devices has not yet approached the goal of destination therapy. A better understanding of the role of left ventricular remodeling in the development of heart failure has resulted in novel surgical therapies and devices that may reverse or retard the remodeling process.