Papers by Mark S. Slaughter
Journal of Thoracic Disease, 2014
Heart failure remains a major global problem with approximately 6 million individuals suffering f... more Heart failure remains a major global problem with approximately 6 million individuals suffering from heart failure in the United States alone. The surgical technique of heart transplantation, popularized by Dr. Norman Shumway, has led to its success and currently remains the best treatment options for patients with end-stage. However, with the continued limitation of donor organs and the rapid development of ventricular assist device technology, the number of patients bridged to transplant with mechanical circulatory support has increased significantly. This has created some new technical challenges for heart transplantation. Therefore, it is now important to be familiar with multiple new technical challenges associated with the surgical techniques of heart transplantation with an ultimate goal in reducing donor heart ischemic time, recipient cardiopulmonary bypass time and post-operative complications. In this review, we described our technique of heart transplantation including th...
Heart Transplantation, Oct 10, 2018
Adults with congenital heart disease (ACHD) have emerged as a new patient population that poses a... more Adults with congenital heart disease (ACHD) have emerged as a new patient population that poses a variety of treatment and management obstacles. This chapter discusses the diagnosis of heart failure and treatment challenges faced by ACHD specifically addressing when to initiate mechanical circulatory support versus heart transplantation. It is evident that the ACHD population presents with a variety of unique challenges and considerations that still need to be explored. Addressing each of these issues will vastly change and improve how ACHD patients are approached from a treatment standpoint and ultimately provide more advantageous clinical options that can successfully handle the complexities presented by this population.
European heart journal, Jan 4, 2015
Advanced heart failure is a growing epidemic that leads to significant suffering and economic los... more Advanced heart failure is a growing epidemic that leads to significant suffering and economic losses. The development of left ventricular assist devices (LVADs) has led to improved quality of life and long-term survival for patients diagnosed with this devastating condition. This review briefly summarizes the short history and clinical outcomes of LVADs and focuses on the current controversies and issues facing LVAD therapy. Finally, the future directions for the role of LVADs in the treatment of end-stage heart failure are discussed.
The Annals of thoracic surgery, Jan 9, 2015
The shortage of donor hearts has limited cardiac transplantation for end-stage heart failure, lea... more The shortage of donor hearts has limited cardiac transplantation for end-stage heart failure, leading to the increased use of left ventricular assist devices (LVADs) as bridge-to-transplant (BTT) and marginal donor hearts; however, outcomes have been mixed. This study examines differences in wait list survival of patients with continuous flow LVADs and post-transplantation survival of patients receiving a marginal donor heart. The United Network of Organ Sharing database was retrospectively queried from January 2005 to June 2013 to identify adult patients listed for heart transplant. Marginal donor criteria included age greater than 55 years, hepatitis C positive, cocaine use, ejection fraction less than 0.45, or donor to recipient body mass index mismatch of greater than 20%. The primary endpoint was wait list survival of patients with LVADs compared with post-transplant survival of marginal donor heart recipients using Kaplan-Meier analysis. A total of 2,561 and 4,737 patients rec...
Texas Heart Institute journal / from the Texas Heart Institute of St. Luke's Episcopal Hospital, Texas Children's Hospital, 2011
Texas Heart Institute Journal, 2014
Interventional Cardiology, 2011
Mortality in patients suffering from cardiogenic shock remains high. The article by Kar et al. pr... more Mortality in patients suffering from cardiogenic shock remains high. The article by Kar et al. presents the results of the largest number of patients in a single-center experience receiving percutaneous ventricular assist device support in cardiogenic shock, despite intra-aortic balloon pump and/or high-dose vasopressors and inotropic therapy. Hemodynamic improvements with the use of the TandemHeart™ (Cardiac Assist Technologies, Inc., PA, USA) device were well documented. The salvage rate for this cohort of patients, the majority of whom would have died without rapid implementation of mechanical circulatory support, was remarkable. As would be expected for application in refractory shock, there was also a high rate of mortality and adverse events. Nonetheless, the authors have demonstrated that the rapid deployment of mechanical circulatory assistance can positively influence outcomes in refractory cardiogenic shock. KEyworDS: cardiogenic shock n heart failure n intra-aortic balloon pump n percutaneous ventricular assist device n TandemHeart™
ChronoPhysiology and Therapy, 2011
Traditionally, blood pressure measurements have been performed in office settings and have provid... more Traditionally, blood pressure measurements have been performed in office settings and have provided the basis for all diagnostic and therapeutic decisions. However, the development of a clinically relevant 24-hour blood pressure monitoring system has added greatly to the ability of blood pressure values to confer additional clinical information, including prognostic value. Mechanistically, the circadian rhythm of blood pressure is mediated by a complex process as a part of the neurohormonal cascade. Pattern recognition of blood pressure peaks and troughs over a 24-hour period has led to categorization into specific subsets namely, ie, dippers, nondippers, extreme dippers, and reverse dippers. Cardiovascular risk is associated with certain pattern types, as has been demonstrated in large observational and prospective studies. The development of therapies for the purpose of restoring more pathological patterns to normal ones continues to grow. These include both pharmaceutical and device therapy. This article describes the development of 24-hour blood pressure monitoring systems, the identification of circadian blood pressure patterns, and the treatment strategies studied thus far which affect these newer blood pressure parameters.
JACC: Heart Failure, 2014
The study sought to assess feasibility, safety, and potential efficacy of a novel implantable ext... more The study sought to assess feasibility, safety, and potential efficacy of a novel implantable extra-aortic counterpulsation system (C-Pulse) in functional class III and ambulatory functional class IV heart failure (HF) patients. BACKGROUND 30% to 40% of HF patients suffer from poor functional status and quality of life (QoL) but are not in need of end-stage treatments. We undertook a multicenter single-arm study to assess the C-Pulse System in such patients. METHODS New York Heart Association (NYHA) functional class III or ambulatory functional class IV HF patients were eligible. Safety was assessed continuously through 12 months. Efficacy measurements included changes from baseline to 6 and 12 months in NYHA functional class, Minnesota Living with Heart Failure (MLWHF) and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, 6-min walk distance (6MWD), and exercise peak oxygen consumption (pVO 2 ; 6 months only). RESULTS Twelve men and 8 women (56.7 AE 7 years, 34 to 71 years of age) with ischemic (n ¼ 7) or nonischemic (n ¼ 13) cardiomyopathy were implanted. There was no 30-day mortality and no neurological events or myocardial infarctions through 12 months. At 6 months, there were 3 deaths (1 device-related). One-year survival was 85%. At 6 months, C-Pulse produced improvements in NYHA functional class (3.1 AE 0.3 to 1.9 AE 0.7, p ¼ 0.0005), MLWHF (63.6 AE 19.9 to 40.2 AE 23.2, p ¼ 0.0005), and KCCQ scores (43.6 AE 21.1 to 65.6 AE 21.5, p ¼ 0.0002), but not 6MWD (275.5 AE 64.0 to 296.4 AE 104.9, p ¼ NS) or pVO 2 (14.5 AE 3.6 to 13.1 AE 4.4, p ¼ NS). Improvements continued at 12 months, with 6MWD change becoming statistically significant (336.5 AE 91.8, p ¼ 0.0425).
ASAIO Journal, 2014
Biomaterials with direct intramyocardial injection devices have been developed and are being inve... more Biomaterials with direct intramyocardial injection devices have been developed and are being investigated as a potential cardiac regenerative therapy for end-stage ischemic heart failure. Decellularized extracellular matrix (ECM) has been shown to improve cardiac function and attenuate or reverse pathologic remodeling cascades. CorMatrix Cardiovascular, Inc. has developed a porcine small intestinal submucosaderived particulate extracellular matrix (P-ECM) and ECM Delivery System to provide uniform and controlled intramyocardial delivery of the injectable P-ECM material into infarcted regions. The CorMatrix ECM Delivery System is composed of a Multi-Needle P-ECM Syringe Assembly, Automated Injection Controller, and Tissue Depth Measurement System (portable ultrasound). Feasibility of the P-ECM delivery system was tested intraoperatively in a chronic ischemic heart failure bovine model (n = 11), and demonstrated the ability to control injection volume (0.1-1.0 ml) and depth of penetration (3-5 mm) under regulated injection pressure (150 psi CO 2) into the ischemic region. Targeted intramyocardial delivery of P-ECM may improve efficacy and enable development of novel patient-specific therapy.
ASAIO Journal, 2014
APK Advanced Medical Technologies (Atlanta, GA) is developing a sutureless beating heart (SBH) le... more APK Advanced Medical Technologies (Atlanta, GA) is developing a sutureless beating heart (SBH) left ventricular assist device (LVAD) connector system consisting of anchoring titanium coil, titanium cannula with integrated silicone hemostatic valve, coring and delivery tool, and LVAD locking mechanism to facilitate LVAD inflow surgical procedures. Feasibility testing was completed in human cadavers (n=4) under simulated normal and hypertensive conditions using saline to observe seal quality in degraded human tissue and assess anatomic fit; acutely in ischemic heart failure (IHF) bovine model (n=2) to investigate short-term performance and ease of use; and chronically for 30-days in healthy calves (n=2) implanted with HeartWare HVAD to evaluate performance and biocompatibility. Complete hemostasis was achieved in human cadavers and animals at LV pressures up to 170 mmHg. In animals, off pump (no cardiopulmonary bypass) anchoring of the connector was accomplished in less than 1 minute with no residual bleeding after full delivery and locking of the LVAD; and implant of connector and LVAD were successfully completed in under 10 minutes with total procedure blood loss less than 100mL. In chronic animals prior to necropsy, no signs of leakage or disruption at the attachment site were observed at systolic LV pressures >200 mmHg.
The Journal of Thoracic and Cardiovascular Surgery, 2011
Journal of the American College of Cardiology, 2010
Background: Continuous flow (CF) left ventricular assist devices (LVADs) have been shown to impro... more Background: Continuous flow (CF) left ventricular assist devices (LVADs) have been shown to improve quality of life (QoL) and functional capacity (FC) in patients (pts) with advanced heart failure (HF). We evaluated the impact of age, gender, and indication (bridge to transplant [BTT] vs destination therapy [DT]) on QoL and FC in pts with a CF LVAD. Methods: We analyzed paired data from the multicenter HeartMate II LVAD BTT (n=90) and DT trials (n=200). HF-related QoL (Minnesota Living with Heart Failure [MLWHF], Kansas City Cardiomyopathy Questionnaires [KCCQ]) and FC (6-minute walk distance [6MWD]) at baseline and 6 months were measured. Changes by gender and age in BTT and DT pts were compared. Results: DT pts were older (62±12 vs 51±13), more had ischemic etiology (58% vs 46%), with similar percentage of women (25% vs 24%) vs BTT pts. There were significant improvements in QoL and FC in all pts at 6 months. No differences in the magnitude of improvement in QoL or FC were observed by gender or age. Improvements in QoL scores were greater in DT pts than in BTT pts for KCCQ (figure) and MLWHF scores (DT: Δ=39±28; BTT: Δ=28±28, p=0.003). Improvements in 6MWD after 6 months were similar (BTT: Δ=167±133m; DT Δ=205±184m, p=0.42). Conclusions: All pts showed significant improvement in QoL with CF LVAD, but DT pts had more pronounced changes than BTT pts. This improvement cannot be directly attributed to age and may be related to severity of illness and comorbid conditions before LVAD support and greater QoL benefit during support.
Journal of the American College of Cardiology, 2011
Background: The Seattle Heart Failure Model (SHFM) is a well-validated and calibrated risk model.... more Background: The Seattle Heart Failure Model (SHFM) is a well-validated and calibrated risk model. We sought to estimate the impact of ventricular assist device (VAD) therapy in the HeartWare HVAD Bridge-to-Transplant ADVANCE trial by comparing observed survival to that predicted with medical therapy by the SHFM in 140 patients. Methods: The SHFM was calculated with the inclusion of inotropes, intra-aortic balloon pumps (IABP) and a diminished benefit of the ICD as the annual mortality increases (J Heart Lung Transplant 2010:1021-5). A t statistic was used to estimate the P value of the observed HVAD survival vs. SHFM estimated survival with continued medical therapy.. Results: The patients were high risk with 26% on IABP/ventilator, 76% on inotropes, systolic blood pressure 104±1mmHg, and a high diuretic requirement (furosemide 7.0±1.8 mg/kg/day). The overall estimated hazard ratio for HVAD benefit was ~0.15 at 30, 90, 180 and 365 days, consistent with an ~85% reduction in mortality vs. the SHFM estimated survival with medical therapy (all P<0.0001). Patients with an IABP (n=35) had an estimated ~95% reduction in mortality at 1 year with the HVAD (P<0.0001). Patients with (n=77) and without inotropes (n=28) had an ~85% and ~80% reduction in mortality at 1 year with the HVAD (p<0.0001 and p=0.002). There was no evidence that the post VAD survival varied with the pre VAD SHFM estimated risk. The SHFM model predicted survival and the observed HVAD outcomes will be presented. Conclusions: The SHFM can be used to describe patients who are currently receiving VADs and may potentially serve as a virtual control arm in single arm trials. The survival with the HVAD did not vary by the baseline risk of the SHFM. It is estimated that the HVAD reduced mortality by ~85% vs. continued medical therapy.
The Journal of Heart and Lung Transplantation, 2010
The circadian rhythm of varying blood pressure and heart rate is attenuated or absent in patients... more The circadian rhythm of varying blood pressure and heart rate is attenuated or absent in patients with severe heart failure. In 28 patients supported by a left ventricular assist device (LVAD) for at least 30 days, a restoration of the circadian rhythm was demonstrated by a consistent nocturnal decrease, and then increase, of the LVAD flow while at a constant LVAD speed. The return of the circadian rhythm has implications for cardiac recovery, and the observation indicates that the continuous-flow LVAD has an intrinsic automatic response to physiologic demands.
The Journal of Heart and Lung Transplantation, 2013
BACKGROUND: The HeartWare Ventricular Assist System (HeartWare Inc, Framingmam, MA) is a miniatur... more BACKGROUND: The HeartWare Ventricular Assist System (HeartWare Inc, Framingmam, MA) is a miniaturized implantable, centrifugal design, continuous-flow blood pump. The pivotal bridge to transplant and continued access protocols trials have enrolled patients with advanced heart failure in a bridge-to-transplant indication. METHODS: The primary outcome, success, was defined as survival on the originally implanted device, transplant, or explant for ventricular recovery at 180 days. Secondary outcomes included an evaluation of survival, functional and quality of life outcomes, and adverse events. RESULTS: A total of 332 patients in the pivotal bridge to transplant and continued access protocols trial have completed their 180-day primary end-point assessment. Survival in patients receiving the HeartWare pump was 91% at 180 days and 84% at 360 days. Quality of life scores improved significantly, and adverse event rates remain low. CONCLUSIONS: The use of the HeartWare pump as a bridge to transplant continues to demonstrate a high 180-day survival rate despite a low rate of transplant. Adverse event rates are similar or better than those observed in historical bridge-to-transplant trials, despite longer exposure times due to longer survival and lower transplant rates.
Journal of Cardiac Surgery, 2010
Aortic valve insufficiency can be addressed during continuousflow left ventricular assist device ... more Aortic valve insufficiency can be addressed during continuousflow left ventricular assist device (CF-LVAD) implantation by performing aortic valve repair or replacement, or patch closure of the left ventricular outflow tract (LVOT). However, few studies have examined the safety of long-term CF-LVAD support after LVOT closure. From November 2003 through March 2016, 16 patients with advanced chronic heart failure underwent CF-LVAD implantation and concomitant LVOT closure for severe aortic insufficiency. We compared their long-term outcomes with those of 510 CF-LVAD recipients without concomitant LVOT closure. Total support time was 26.1 patientyears in the LVOT-closure group and 938.6 patient-years in the CF-LVAD-only group. Survival at 30 days, 6 months, 1 year, and 2 years was similar for CF-LVAD-only patients (90.4%, 80.6%, 74.3%, 67.5%) and LVOT-closure patients (81.3%, 81.3%, 75.0%, 68.8%; p = 0.59). There were no deaths related to LVOT closure. The event rate per patient-year for neurologic dysfunction (ND) was 0.23 in the LVOT-closure group (6 ND events) and 0.20 in the CF-LVAD-only group (136 ND events; p = 0.97). We conclude that for select patients with aortic insufficiency who are undergoing CF-LVAD implantation, LVOT closure produces acceptable outcomes and, therefore, is a viable option.
The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation, 2012
The HeartMate II (Thoratec Corp, Pleasanton, CA) continuous-flow left ventricular assist device (... more The HeartMate II (Thoratec Corp, Pleasanton, CA) continuous-flow left ventricular assist device (LVAD) improved survival in destination therapy (DT) patients during a randomized trial compared with pulsatile-flow LVADs. This study documented changes in cognitive performance in DT patients from that trial to determine if there were differences between continuous-flow and pulsatile-flow support.
Expert Review of Cardiovascular Therapy, 2008
Acute myocardial infarction complicated by cardiogenic shock (AMI-CS) is the leading cause of in-... more Acute myocardial infarction complicated by cardiogenic shock (AMI-CS) is the leading cause of in-hospital death for patients admitted with acute coronary syndromes. Expert guidelines for the care of AMI-CS patients recommend early revascularization with intra-aortic balloon pump support. Ventricular assist devices (VADs) offer the advantages of providing greater and longer-term cardiac support than an intra-aortic balloon pump and may improve outcomes when inserted early after heart failure symptoms begin. Pulsatile VADs are versatile and can provide biventricular support but are associated with a higher incidence of serious complications. The newer percutaneous VADs can normalize cardiac index and can be implanted without surgery. Therefore, early implementation of percutaneous VADs and early revascularization may reduce the high mortality of AMI-CS. However, access to revascularization and VAD support, including percutaneous VADs, is currently limited and must improve to more effectively treat AMI-CS patients.
Biomedical Instrumentation & Technology, 2011
Preclinical hemolysis testing is a critical requirement toward demonstrating device safety for U.... more Preclinical hemolysis testing is a critical requirement toward demonstrating device safety for U.S. Food and Drug Administration (FDA) 510(k) approval of mechanical circulatory support devices (MCSD). FDA and ASTM (formerly known as the American Society for Testing and Materials) have published guidelines to assist industry with developing study protocols. However, there can be significant variability in experimental procedures, study design, and reporting of data that makes comparison of test and predicate devices a challenge. To overcome these limitations, we present a hemolysis testing protocol developed to enable standardization of hemolysis testing while adhering to FDA and ASTM guidelines. Static mock flow loops primed with fresh bovine blood (600 mL, Hematocrit = 27±5%, heparin titrated for ACT >300 sec) from a single-source donor were created as a platform for investigating test and predicate devices. MCSD differential pressure and temperature were maintained at 80 mmHg a...
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Papers by Mark S. Slaughter