Publications by authors named "Jeffrey A Morgan"

160 Publications

Primary intra-abdominal melanoma arising in association with extracutaneous blue naevus: a report of two cases.

Histopathology 2021 Jan 16;78(2):281-289. Epub 2020 Oct 16.

Department of Pathology, Brigham and Women's Hospital, Boston, MA, USA.

Aims: Blue naevi are uncommon dermal melanocytic neoplasms characterised by GNAQ/GNA11 mutations, which very rarely progress to melanoma. Such melanomas also often have BAP1 mutations, and lack genetic events associated with conventional melanoma. Exceptionally, blue naevi arise in extracutaneous locations; one melanoma arising in this setting has been reported. We report the clinicopathological, immunohistochemical and molecular genetic features of two cases of melanoma arising in extracutaneous blue naevus.

Methods And Results: Both arose in males, aged 25 and 63 years, with no history of other melanocytic lesions, and presented as large, painful intra-abdominal masses. The tumours were dark-brown/black, multilobulated, involved small intestinal mesentery and consisted of a predominantly fascicular and spindled, but occasionally nested and epithelioid, proliferation of variably pigmented, relatively monotonous cells with pale cytoplasm and ovoid nuclei with mild to moderate atypia. Mitotic activity was variable but generally low. Both cases showed areas of conventional and cellular blue naevus. Recurrent tumour in one case showed predominantly epithelioid morphology and greater cytological atypia and mitotic activity. One case expressed Melan-A, SOX10 and CD117, with absent expression of S100 protein and DOG1; the other expressed Melan-A, HMB45 and S100 protein. Next-generation sequencing identified GNAQ and BAP1 mutations in one case and GNA11 mutation in the other. Both patients developed widespread metastatic disease.

Conclusion: Exceptionally rare, aggressive melanomas arising in extracutaneous blue naevi should be distinguished from metastatic melanoma, gastrointestinal stromal tumour and malignant melanotic nerve sheath tumour, especially given the significant therapeutic and prognostic differences between these different entities.
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http://dx.doi.org/10.1111/his.14219DOI Listing
January 2021

Sternum-Sparing HVAD Implantation with Attachment of the Outflow Graft to the Descending Aorta.

ASAIO J 2020 Sep/Oct;66(9):1006-1013

From the Division of Cardiothoracic Transplant and Assist Devices, Baylor College of Medicine, Houston, Texas.

The standard approach for implanting an HVAD left ventricular assist device (LVAD) is performing a median sternotomy and sewing the outflow graft to the ascending aorta. However, in patients with sternal comorbidities, it may be advantageous to use a sternum-sparing approach. We retrospectively studied eight patients who underwent HVAD implantation for destination therapy via a left subcostal or fifth/sixth intercostal space incision. With this procedure, the outflow graft was sewed to the descending aorta. Ninety-day and one-year survival rates were 87.5% and 75%, respectively. Two patients (25%) died during the perioperative period: one from multisystem organ failure and the other from unrelated causes. We adjusted the HVAD speed to open the aortic valve once every three to four beats. Compared with other continuous-flow LVAD implantations performed at our institution during the study period (n = 437), this technique resulted in shorter bypass times and a lower incidence of infection; it was not associated with an increased incidence of heart failure, aortic root thrombosis, pump thrombosis, progression of aortic insufficiency, or ischemic neurologic dysfunction. Our findings suggest that a sternum-sparing approach for HVAD implantation is feasible and may be a safe option in patients with serious comorbidities that preclude the use of traditional implantation techniques.
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http://dx.doi.org/10.1097/MAT.0000000000001136DOI Listing
March 2021

Plasmapheresis in Patients With Heparin-induced Thrombocytopenia Requiring Ventricular Assist Device.

Ann Thorac Surg 2020 06 9;109(6):e439-e440. Epub 2019 Nov 9.

Division of Cardiothoracic Transplantation and Circulatory Support, Baylor College of Medicine, Houston, Texas.

Anticoagulation with unfractionated heparin is vital to reduce the risk of thromboembolic events during cardiopulmonary bypass and left ventricular assist device placement. However patients with heparin-induced thrombocytopenia are at risk of developing immune-mediated thrombotic events. We describe 2 patients with heparin-induced thrombocytopenia confirmed via serotonin release assay who were successfully treated with plasmapheresis exchange before left ventricular assist device placement.
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http://dx.doi.org/10.1016/j.athoracsur.2019.09.056DOI Listing
June 2020

Effect of cardiac arrest with aortic cross-clamping during left ventricular assist device implantation.

Interact Cardiovasc Thorac Surg 2020 01;30(1):47-53

Division of Cardiothoracic Transplantation and Circulatory Support, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, USA.

Objectives: Some patients who undergo continuous-flow left ventricular assist device (CF-LVAD) implantation require concomitant procedures that can be performed with or without cardiac arrest under aortic cross-clamping (AXC). Procedures normally performed with cardiac arrest are sometimes avoided or performed without cardiac arrest because it may be detrimental to right heart function. However, the effects of cardiac arrest on patients with advanced heart failure necessitating CF-LVAD support have not been thoroughly studied. We examined our single-centre experience to determine whether cardiac arrest during CF-LVAD implantation was associated with worse patient outcomes.

Methods: From November 2003 to March 2016, a total of 526 patients with chronic end-stage heart failure underwent primary CF-LVAD implantation. Preoperative demographics, postoperative complications and mortality rates were compared between patients who required cardiac arrest with AXC (n = 50) and those who did not (n = 476).

Results: The most frequently performed procedure requiring AXC was aortic valve closure (n = 23, 26.1%). Although the AXC group had longer cardiopulmonary bypass times (P < 0.01), long-term (5-year) survival was similar in AXC and non-AXC patients (P = 0.13). Also, postoperative right heart failure (P = 0.15) and neurological dysfunction (P = 0.89) rates were not significantly different between the 2 groups. Cox proportional hazards analysis showed that cardiac arrest with AXC was not an independent predictor of mortality (hazard ratio, 0.89; P = 0.73).

Conclusions: Cardiac arrest with AXC during CF-LVAD implantation did not negatively affect long-term survival or the incidence of right ventricular failure or stroke. These findings should be considered in deciding surgical strategies. Additional investigation may be warranted to further understand the effects of cardiac arrest during LVAD implantation.
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http://dx.doi.org/10.1093/icvts/ivz223DOI Listing
January 2020

Reply.

Ann Thorac Surg 2020 03 14;109(3):988. Epub 2019 Sep 14.

Division of Cardiothoracic Transplantation and Circulatory Support, Baylor College of Medicine, Houston, Texas.

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http://dx.doi.org/10.1016/j.athoracsur.2019.07.088DOI Listing
March 2020

Device exchange from Heartmate II to HeartWare HVAD.

J Card Surg 2019 Nov 3;34(11):1204-1207. Epub 2019 Sep 3.

Division of Cardiothoracic Transplant and Mechanical Circulatory Support, Baylor College of Medicine, Houston, Texas.

Background: Despite technological advancements, pump durability and pump-related complications continue to affect and adversely impact the lives of patients with end-stage heart failure on left ventricular assist device (LVAD) support. In an attempt to avoid recurrent LVAD-related complications, there may be circumstances where it is clinically advantageous to exchange a patient's device from HeartMate II to HeartWare HVAD. However, there is a paucity of data that describes the safety and feasibility of such an approach.

Objective: We present the largest single-center series of HeartMate II (HMII) to HeartWare (HVAD) device exchanges.

Methods: A retrospective review of 11 patients who underwent HMII to HVAD exchange from 2012 to 2017 was conducted to evaluate patient characteristics, incidence of postoperative complications, and survival.

Results: Eleven male patients (mean age 55 ± 14.4 years) underwent HMII to HVAD device exchange. One patient expired on postoperative day 7 secondary to sepsis. One patient was lost-to-follow-up after 23 months. An additional three patients died at 5, 7, and 24 months. Mean follow-up after device exchange was 1555 ± 311 days for the remaining six patients. None of the 11 study patients underwent LVAD explant, further device exchange, or heart transplant.

Conclusion: Exchange of an HMII LVAD to an HVAD can be performed safely with acceptable perioperative morbidity and mortality.
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http://dx.doi.org/10.1111/jocs.14229DOI Listing
November 2019

Phase I Study of Rapid Alternation of Sunitinib and Regorafenib for the Treatment of Tyrosine Kinase Inhibitor Refractory Gastrointestinal Stromal Tumors.

Clin Cancer Res 2019 12 30;25(24):7287-7293. Epub 2019 Aug 30.

Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.

Purpose: Polyclonal emergence of KIT secondary mutations is a main mechanism of imatinib progression in gastrointestinal stromal tumor (GIST). Approved KIT inhibitors sunitinib and regorafenib have complementary activity against KIT resistance mutations. Preclinical evidence suggests that rapid alternation of sunitinib and regorafenib broadens the spectrum of imatinib-resistant subclones targeted.

Patients And Methods: Phase Ib study investigating continuous treatment with cycles of sunitinib (3 days) followed by regorafenib (4 days) in patients with tyrosine kinase inhibitor (TKI)-refractory GIST. A 3+3 dosing schema was utilized to determine the recommended phase II dose (RP2D). Plasma samples were analyzed for pharmacokinetics and circulating tumor DNA (ctDNA) studies using targeted error correction sequencing (TEC-seq) and droplet digital PCR (ddPCR).

Results: Of the 14 patients enrolled, 2 experienced dose-limiting toxicities at dose level 2 (asymptomatic grade 3 hypophosphatemia). Sunitinib 37.5 mg/day and regorafenib 120 mg/day was the RP2D. Treatment was well-tolerated and no unexpected toxicities resulted from the combination. Stable disease was the best response in 4 patients, and median progression-free survival was 1.9 months. Combined assessment of ctDNA with TEC-seq and ddPCR detected plasma mutations in 11 of 12 patients (92%). ctDNA studies showed that KIT secondary mutations remain the main mechanism of resistance in TKI-refractory GIST, revealing effective suppression of KIT-mutant subpopulations in patients benefiting from the combination.

Conclusions: Sunitinib and regorafenib combination is feasible and tolerable. Rapid alternation of TKIs with complementary activity might be effective when combining drugs with favorable pharmacokinetics, potentially allowing active doses while minimizing adverse events. Serial monitoring with ctDNA may guide treatment in patients with GIST.
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http://dx.doi.org/10.1158/1078-0432.CCR-19-2150DOI Listing
December 2019

Accuracy of Postoperative Risk Scores for Survival Prediction in Interagency Registry for Mechanically Assisted Circulatory Support Profile 1 Continuous-Flow Left Ventricular Assist Device Recipients.

ASAIO J 2020 05;66(5):539-546

Division of Cardiothoracic Surgery, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.

In this study, we sought to determine the accuracy of several critical care risk scores for predicting survival of Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profile 1 patients after continuous-flow left ventricular assist device (CF-LVAD) placement. We retrospectively analyzed the records of 605 patients who underwent CF-LVAD implantation between 2003 and 2016. We calculated the preoperative HeartMate II Risk Score (HMRS) and preoperative Right Ventricular Failure Risk Score (RVFRS) and the following risk scores for postoperative days 1-5: HMRS, RVFRS, Model for End-stage Liver Disease (MELD), MELD-eXcluding International Normalized Ratio, Post Cardiac Surgery (POCAS) risk score, Sequential Organ Failure Assessment (SOFA) risk score, and Acute Physiology and Chronic Health Evaluation III. The preoperative scores and the postoperative day 1, 5-day mean, and 5-day maximum scores were entered into a receiver operating characteristic curve analysis to examine accuracy for predicting 30-day, 90-day, and 1-year survival. The mean POCAS score was the best predictor of 30-day and 90-day survival (area under the curve [AUC] = 0.869 and 0.816). The postoperative mean RVFRS was the best predictor of 1-year survival (AUC = 0.7908). The postoperative maximum and mean RVFRS and HMRS were more accurate than the preoperative scores. Both of these risk score measurements of acuity in the postoperative intensive care unit setting help predict early mortality after LVAD implantation.
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http://dx.doi.org/10.1097/MAT.0000000000001044DOI Listing
May 2020

Acute Kidney Injury With Ventricular Assist Device Placement: National Estimates of Trends and Outcomes.

Am J Kidney Dis 2019 11 1;74(5):650-658. Epub 2019 Jun 1.

Selzman Institute for Kidney Health, Section of Nephrology, Department of Medicine; Section of Nephrology, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX.

Rationale & Objective: Ventricular assist devices (VADs) are used for end-stage heart failure not amenable to medical therapy. Acute kidney injury (AKI) in this setting is common due to heart failure decompensation, surgical stress, and other factors. Little is known about national trends in AKI diagnosis and AKI requiring dialysis (AKI-D) and associated outcomes with VAD implantation. We investigated national estimates and trends for diagnosed AKI, AKI-D, and associated patient and resource utilization outcomes in hospitalizations in which implantable VADs were placed.

Study Design: Cohort study of 20% stratified sample of US hospitalizations.

Setting & Participants: Patients who underwent implantable VAD placement in 2006 to 2015.

Exposure: No AKI diagnosis, AKI without dialysis, AKI-D.

Outcomes: In-hospital mortality, length of stay, estimated hospitalization costs.

Analytical Approach: Multivariate logistic and linear regression using survey design methods to account for stratification, clustering, and weighting.

Results: An estimated 24,140 implantable VADs were placed, increasing from 853 in 2006 to 3,945 in 2015. AKI was diagnosed in 56.1% of hospitalizations and AKI-D occurred in 6.5%. AKI diagnosis increased from 44.0% in 2006 to 2007 to 61.7% in 2014 to 2015; AKI-D declined from 9.3% in 2006 to 2007 to 5.2% in 2014 to 2015. Mortality declined in all AKI categories but this varied by category: those with AKI-D had the smallest decline. Adjusted hospitalization costs were 19.1% higher in those with diagnosed AKI and 39.6% higher in those with AKI-D, compared to no AKI.

Limitations: Administrative data; timing of AKI with respect to VAD implantation cannot be determined; limited pre-existing chronic kidney disease ascertainment; discharge weights not derived for subpopulation of interest.

Conclusions: A decreasing proportion of patients undergoing VAD implantation experience AKI-D, but mortality among these patients remains high. AKI diagnosis with VAD implantation is increasing, possibly reflecting changes in AKI surveillance, awareness, and coding.
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http://dx.doi.org/10.1053/j.ajkd.2019.03.423DOI Listing
November 2019

Donation After Cardiac Death: A Necessary Expansion for Heart Transplantation.

Semin Thorac Cardiovasc Surg 2019 Winter;31(4):721-725. Epub 2019 May 16.

Division of Mechanical Circulatory Support and Cardiac Transplantation, Baylor College of Medicine, Houston, Texas; Department of Cardiothoracic Surgery, Texas Heart Institute, Houston, Texas. Electronic address:

The gold standard and sole curative therapy for advanced stage heart failure is cardiac transplantation. As the population ages, the number of patients diagnosed with advanced heart failure and listed for transplant steadily increases annually. However, there remains a paucity of eligible donation after brain death (DBD) donor hearts which severely limits access to cardiac transplantation and leads to increasing wait-list times and avoidable patient mortalities. Though the first human heart transplant in 1967 was performed using a deceased donor heart, the advent of brain death criteria and the ability to avoid long warm ischemic times led donation after cardiac death (DCD) transplantation to fall out of favor. Due the current state of cardiac transplantation, there has been a resurgence in interest in DCD heart transplantation leading to the development of DCD heart transplantation programs in the UK and Australia after positive reports of successful DCD cardiac transplantation in the pediatric literature. These programs have demonstrated favorable post-transplantation outcomes equivalent to matched traditional DBD transplants with current techniques and strict donor criteria. This technique has been proven safe with favorable outcomes and has been demonstrated to significantly increase transplant volumes and decrease patient mortality. Given these outcomes and the high patient benefit to risk ratio, DCD donor heart transplantation is necessary to expand the donor pool and decrease patient mortality and should be developed in high volume experienced cardiac transplant centers.
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http://dx.doi.org/10.1053/j.semtcvs.2019.05.010DOI Listing
January 2020

Gastrointestinal Bleeding After HeartMate II or HVAD Implantation: Incidence, Location, Etiology, and Effect on Survival.

ASAIO J 2020 03;66(3):283-290

From the Division of Cardiothoracic Transplantation and Circulatory Support, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.

The number of patients on destination therapy is increasing as long-term survival on continuous-flow left ventricular assist device (CF-LVAD) therapy has improved. Gastrointestinal bleeding (GIB) is a common complication after CF-LVAD implantation, and its risk correlates with longer support time, emphasizing the importance of GIB management. The lower pulsatility of CF-LVADs may promote arteriovenous malformations, which amplify the bleeding risk. Here, we retrospectively analyzed the location, incidence, and survival effect of GIB events in HeartMate II (HM-II) and HeartWare Ventricular Assist Device (HVAD) recipients to provide specific details regarding these complications. From November 2003 to March 2016, 526 patients with chronic heart failure underwent primary implantation of an HM-II (n = 403) or HVAD (n = 123) CF-LVAD at our center. Of the 526 patients, 140 (26.6%) had a GIB event (HM-II: n = 100; HVAD: n = 40), 92 (17.5%) had a single GIB event, and 48 (9.1%) had multiple GIB events (range: 2-9 events). HVAD recipients had a higher incidence of both upper and lower GIB events (p < 0.001 and P = 0.002, respectively) than HM-II recipients. Arteriovenous malformation was the most common etiology for GIB (50 patients/72 events); for this group, the average time-to-event was 300.4 days, the recurrence rate was 34%, and the 90-day and 1-year survival rates were 88.3% and 66.7%, respectively. Age at implantation was the only predictor of GIB. In conclusion, our study provides detailed information about GIB events associated with current CF-LVADs. Additional studies are required to evaluate strategies to reduce the incidence of GIB morbidity.
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http://dx.doi.org/10.1097/MAT.0000000000000998DOI Listing
March 2020

Concomitant valve procedures in patients undergoing continuous-flow left ventricular assist device implantation: A single-center experience.

J Thorac Cardiovasc Surg 2019 10 21;158(4):1083-1089.e1. Epub 2019 Feb 21.

Division of Cardiothoracic Transplant and Assist Devices, Baylor College of Medicine, Houston, Tex.

Objective: Long-term support with continuous-flow left ventricular assist devices (CF-LVADs) has improved the outcomes of patients with end-stage heart failure. However, valve disease management in patients who undergo CF-LVAD implantation remains controversial. The aim of this study was to assess our single-center experience with patients who underwent a concomitant valve procedure during implantation of a CF-LVAD.

Methods: From November 2003 through March 2016, 526 patients underwent primary CF-LVAD implantation with a HeartMate II (St Jude Inc, St Paul, Minn; n = 403) or HeartWare (Medtronic, Minneapolis, Minn; n = 123) device at our center. Of those, 91 underwent a concomitant valve procedure during implantation (CF-LVAD+valve procedure group), whereas 435 did not (CF-LVAD-only group). We compared preoperative characteristics and short-term and mid-term survival rates between these groups.

Results: The concomitant valve procedures performed included 13 tricuspid valve repairs, 19 aortic valve repairs or replacements, 30 mitral valve repairs or replacements, and 29 double valve repairs or replacements. Survival rates at 1 month, 6 months, 12 months, and 24 months were 90.3%, 81.4%, 74.9%, and 67.4%, respectively, for the CF-LVAD-only group and 89.0%, 75.8%, 70.3%, and 65.9%, respectively, for the CF-LVAD+valve procedure group (P = .55). The results of Cox regression multivariable modeling showed that performing a concomitant valve procedure was not an independent predictor of mortality (hazard ratio, 1.29; 95% confidence interval, 0.96-1.74; P = .08).

Conclusions: In our experience, performing a concomitant valve procedure during CF-LVAD implantation was not associated with an increased mortality rate. The decision to perform a concomitant valve procedure should be made primarily on the basis of clinical indications for the procedure.
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http://dx.doi.org/10.1016/j.jtcvs.2019.02.040DOI Listing
October 2019

A left ventricular end-diastolic dimension less than 6.0 cm is associated with mortality after implantation of an axial-flow pump.

J Thorac Cardiovasc Surg 2019 06 21;157(6):2302-2310. Epub 2019 Jan 21.

Division of Cardiothoracic Transplantation and Circulatory Support, Baylor College of Medicine, Houston, Tex.

Objective: The effects of having a lower left ventricular end-diastolic dimension before HeartMate II (Thoratec Corp, Pleasanton, Calif) left ventricular assist device implantation remain unclear. We analyzed our single-center data on HeartMate II implantation to determine whether having a lower left ventricular end-diastolic dimension preoperatively was associated with inferior outcomes.

Methods: From November 2003 to March 2016, 393 patients with chronic heart failure underwent primary HeartMate II implantation. We compared the preoperative left ventricular end-diastolic dimension and associated survival outcomes of these patients to determine the left ventricular end-diastolic dimension cutoff for worse overall survival. Then, we compared the preoperative demographics, stroke rate, and mortality of patients with a left ventricular end-diastolic dimension above the cutoff for worse survival with those of patients with a left ventricular end-diastolic dimension below the cutoff.

Results: A Cox multivariate regression model showed that low left ventricular end-diastolic dimension was an independent predictor of mortality (hazard ratio, 1.49; P = .02). The Contal and O'Quigley method showed that overall survival postimplantation was decreased in patients with a left ventricular end-diastolic dimension less than 6.0 cm (n = 91). Kaplan-Meier analysis confirmed that the left ventricular end-diastolic dimension less than 6.0 cm group had lower overall survival than the left ventricular end-diastolic dimension 6.0 cm or greater group (P = .04). Furthermore, a competing-risk analysis showed that postoperative stroke was more common in the left ventricular end-diastolic dimension less than 6.0 cm group than in the left ventricular end-diastolic dimension 6.0 cm or greater group (P < .01).

Conclusions: Overall survival was decreased and postoperative stroke was increased in HeartMate II recipients with a preoperative left ventricular end-diastolic dimension less than 6.0 cm. Future research should determine the left ventricular end-diastolic dimension cutoff values for safely implanting other support devices, and device designs should be improved to better accommodate the needs of patients with a limited left ventricle size.
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http://dx.doi.org/10.1016/j.jtcvs.2019.01.015DOI Listing
June 2019

Severe LVAD-related infections requiring surgical treatment: Incidence, predictors, effect on survival, and impact of device selection.

J Card Surg 2019 Feb 2;34(2):82-91. Epub 2019 Feb 2.

Division of Cardiothoracic Transplant and Assist Devices, Baylor College of Medicine, Houston, Texas.

Background: Left ventricular assist devices (LVADs) are being used more frequently for treating refractory, advanced heart failure. However, infection remains a frequent complication. In this study, we analyzed the incidence of severe infections in LVAD recipients to determine its impact on survival.

Methods: From May 2009 through March 2016, 437 patients with advanced heart failure underwent implantation of a continuous-flow LVAD (n = 314, HeartMate II LVAD [Abbott Laboratories, Abbott Park, IL]; n = 123 HeartWare HVAD [Medtronic, Minneapolis, MN]). We analyzed the rate of severe device infection requiring surgical intervention or involving sepsis and the impact of severe infection on outcomes in patients on long-term LVAD support.

Results: Infection occurred in 244 patients (HeartMate II, n = 186; HVAD, n = 58); severe infections developed in 160 patients (HeartMate II, n = 119; HVAD, n = 41). HeartMate II recipients had 344 severe infection events (0.63 events per patient-year [EPPY]), whereas HeartWare recipients had 89 severe infection events (0.42 EPPY; P = 0.047). HeartMate II recipients had a higher incidence of pump infections (P < 0.001). Severe infections did not significantly affect survival (P = 0.42).

Conclusions: Although HeartMate II patients had a significantly higher incidence of pump infections requiring surgical treatment, survival was not adversely affected. The difference in postoperative infection rates may be an important factor in device type selection.
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http://dx.doi.org/10.1111/jocs.13987DOI Listing
February 2019

Outcomes of Repeat Left Ventricular Assist Device Exchange.

ASAIO J 2020 01;66(1):64-68

From the Division of Cardiothoracic Transplantation and Circulatory Support, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.

Implantable continuous-flow left ventricular assist devices (CF-LVADs) are used for long-term LV support in bridging patients to heart transplantation or as destination therapy. With prolonged support times, some patients will have repeat complications necessitating multiple device exchanges. To elucidate the safety and efficacy of repeat device exchange, we retrospectively reviewed data from 25 patients who underwent two or more CF-LVAD implantations between July 2005 and August 2017. Indications for exchange were thrombus/hemolysis (n = 8, 32%), electromechanical device malfunction (n = 14, 56%), and infection (n = 3, 12%). The implanted devices were the HeartMate II (n = 13, 52%), the HeartWare HVAD (n = 11, 44%), and the Jarvik 2000 (n = 1, 4%). Average hospital length of stay was 44 days (range 4-221 days), and 17 patients (68%) survived to discharge. Average duration of support after the most recent LVAD implantation was 802 days (range 1-3,229 days). Overall survival was 72% at 1 year and 60% at 2 years. Postoperative complications included respiratory failure in five patients (20%), device infection in five (20%), bleeding requiring reoperation in four (16%), neurologic dysfunction in four (16%), and acute renal failure in two (8%). Overall, our data suggest that repeat LVAD exchange is a feasible option for patients with recurrent device-related complications.
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http://dx.doi.org/10.1097/MAT.0000000000000928DOI Listing
January 2020

Fatal Neurologic Dysfunction During Continuous-Flow Left Ventricular Assist Device Support.

Ann Thorac Surg 2019 04 20;107(4):1132-1138. Epub 2018 Nov 20.

Division of Cardiothoracic Transplantation and Circulatory Support, Baylor College of Medicine, Houston, Texas.

Background: During continuous-flow left ventricular assist device (CF-LVAD) support, neurologic dysfunction (ND) is a common complication and can be fatal. Few reports provide detailed data on neurologic mortality in such patients. Therefore, we examined ND-related mortality during CF-LVAD support.

Methods: Between November 2003 and March 2016, 526 patients underwent implantation of a CF-LVAD (403 HeartMate II [Thoratec, Pleasanton, CA] and 123 HVAD [HeartWare International, Framingham, MA]) at our center. We categorized ND as hemorrhagic or ischemic and recorded resulting deaths. Records were reviewed to determine preoperative demographics, perioperative variables, prevalence and causes of postimplantation ND, duration of support until ND, time from ND to death, laboratory data and medications at the time of ND, post-ND treatment procedures, and causes of hemorrhagic ND. We also performed Cox multivariable logistic regression analysis to identify predictors of ND-related mortality by calculating odds ratios and confidence intervals.

Results: Neurologic dysfunction occurred in 141 patients (26.8%), 48 (9.1%) of whom subsequently died. Median duration of left ventricular assist device support before ND was 230 days (range, 3 to 2,422), and median time from ND to death was 3.5 days (range, 0 to 55). Parenchymal hemorrhage was the most frequent cause of early conversion (76.7%). In the Cox multivariable regression analysis, predictors of fatal ND were age, ischemic cause of heart failure, history of stroke, and longer intraoperative aortic cross-clamp time.

Conclusions: Our study elucidates the characteristics and risk factors of patients who died of ND during CF-LVAD support. Further studies are required to find ways to decrease the incidence of fatal ND during CF-LVAD support.
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http://dx.doi.org/10.1016/j.athoracsur.2018.10.012DOI Listing
April 2019

In Vivo Hemodynamic Evaluation of CH-VAD in a Bovine Model for 14 Days.

Annu Int Conf IEEE Eng Med Biol Soc 2018 Jul;2018:4512-4515

The CH-VAD is a centrifugal-flow magnetically levitated (maglev) left ventricular assist device (LVAD) used to treat end-stage heart failure. It is implanted in the chest cavity; the inflow cannula is inserted into the apex of the left ventricle, and the outflow graft is anastomosed to the aorta. Among several key VAD system improvements, the CH-VAD has a smaller body size than other LVADs and its maglev system offers a large-gap design that makes it superior in terms of hemocompatibility. In this study, we implanted the CH-VAD in a calf and evaluated the hemodynamic and hemocompatibility characteristics over a 14-day period. The hemodynamic parameters, the pump data, and blood test results were recorded throughout the study. The results showed that the CH-VAD provided hemodynamic stability. Hemocompatibility testing indicated negligible hemolysis throughout the study, and no signs of infection were seen. On necropsy, the results showed only expected focal mild-to-moderate adhesions between the pericardial sac (along the pump) and the adjacent rib cage, and between the pericardial sac and the heart. Gross examination of internal organs was unremarkable. Examination of the CH-VAD after explantation revealed no evidence of thrombus formation internally or around the inflow or outflow cannulas.
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http://dx.doi.org/10.1109/EMBC.2018.8513110DOI Listing
July 2018

Effect of concomitant mitral valve procedures for severe mitral regurgitation during left ventricular assist device implantation.

J Artif Organs 2019 Jun 25;22(2):91-97. Epub 2018 Oct 25.

Division of Cardiothoracic Transplantation and Circulatory Support, Baylor College of Medicine, Houston, TX, USA.

The effect of performing a concomitant mitral valve procedure (MVP) during continuous-flow left ventricular assist device (CF-LVAD) implantation has been reported for patients with moderate-to-severe mitral regurgitation (MR), but moderate MR is less of a clinical concern for CF-LVAD patients. There is a paucity of reports focusing on patients with severe MR. Thus, the purpose of this study was to analyze the effect of performing a concomitant MVP during CF-LVAD implantation in patients with severe preoperative MR. Between November 2003 and March 2016, 526 patients underwent primary implantation of a CF-LVAD at our center. Patients with severe MR who underwent a concomitant MVP were compared to those who did not in regard to overall survival, perioperative complications, postoperative echocardiography data, bridge-to-transplantation success, and CF-LVAD explantation. Of the 108 patients with severe MR, 26 underwent a concomitant MVP and 82 did not. These groups showed no difference in survival (p = 0.61). Additionally, the two groups had similar rates of postoperative right heart failure (p = 0.69) and readmissions (p = 0.42). The 24-month follow-up echocardiography results were also similar. Furthermore, the groups showed no difference in bridge-to-cardiac transplantation success (30.0% vs 25.0%, p = 0.80) or CF-LVAD explantation rates (0.0% vs 0.0%. p = 1.0). Our findings suggest that patients with severe MR who undergo a MVP during CF-LVAD implantation do not have superior outcomes to those who do not. However, assessments of other outcomes may show some benefits to performing concomitant MVPs.
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http://dx.doi.org/10.1007/s10047-018-1076-8DOI Listing
June 2019

Total artificial heart implantation as a bridge to transplantation: a viable model for the future?

Expert Rev Med Devices 2018 Oct 26;15(10):701-706. Epub 2018 Sep 26.

c Division of Mechanical Circulatory Support and Cardiac Transplantation , Baylor College of Medicine , Houston , TX , USA.

Introduction: Since the first total artificial heart (TAH) surgery in a human patient performed in 1969, over 1300 devices have been implanted worldwide. Patients are benefiting from increased lengths of durable support and indications have expanded beyond biventricular failure including allograft failure, severe restrictive disease, and complex congenital anomalies. Areas covered: The role of the TAH in biventricular failure, rates of successful bridge-to-transplant (BTT), and survival compared with biventricular assist devices (BiVADs) are discussed and differences between TAH and LVAD patient populations are highlighted. The device's niche role in physiologies not amenable to single ventricle support is further described. New developments such as the 50cc Syncardia, continuous flow mechanisms (BiVACOR and Cleveland Clinic CF-TAH), and a bioprosthetic model (CARMAT) are discussed. Literature review was conducted utilizing the PubMed database selecting published research, database analyses, and case reports under 'total artificial heart' relevant to the paper's aims. Expert commentary: TAH patients have high rates of successful BTT and survival on par with BiVAD-supported patients. Ongoing developments including decreased device size, continuous flow mechanisms, and use of bioprosthetic materials will ensure that the TAH will have an increasing role in advanced heart failure with increased device longevity and decreased post-implant complications.
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http://dx.doi.org/10.1080/17434440.2018.1524294DOI Listing
October 2018

Left Ventricular Recovery with Explantation of Continuous-Flow Left Ventricular Assist Device after 5 Years of Support.

Ann Thorac Cardiovasc Surg 2018 Aug 28. Epub 2018 Aug 28.

Division of Cardiothoracic Transplant and Assist Devices, Baylor College of Medicine, Houston, TX, USA.

Mechanical circulatory support may result in sufficient myocardial recovery to allow for explantation of the left ventricular assist device (LVAD). The duration of support associated with left ventricular recovery has generally been 6-12 months. In this report, we present a patient in whom the left ventricle recovered after 5 years of support with a LVAD. Our report demonstrates that long-term monitoring for left ventricular recovery is prudent and may allow for late device explantation.
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http://dx.doi.org/10.5761/atcs.cr.18-00082DOI Listing
August 2018

Continuous-Flow Left Ventricular Assist Device Therapy in Adults with Transposition of the Great Vessels.

Ann Thorac Cardiovasc Surg 2021 Feb 10;27(1):64-67. Epub 2018 Aug 10.

Division of Cardiothoracic Transplantation and Circulatory Support, Baylor College of Medicine, Houston Texas, USA.

An increasing number of children with congenital heart disease are surviving into adulthood and subsequently developing end-stage heart failure. Two example populations are adults who have been previously operated on for congenitally corrected transposition of the great arteries (CCTGA) and transposition of the great arteries (TGA). Implantation of a continuous flow left ventricular assist device (CF-LVAD) in these patients can present unusual anatomical and physiologic challenges. In this report, we describe outcomes of CF-LVAD implantation in three such patients. These cases demonstrate the feasibility of implanting a CF-LVAD in patients who have undergone surgery for CCTGA and/or TGA.
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http://dx.doi.org/10.5761/atcs.cr.18-00021DOI Listing
February 2021

Long-Term Continuous-Flow Left Ventricular Assist Device Support After Left Ventricular Outflow Tract Closure.

ASAIO J 2019 08;65(6):558-564

From the Division of Cardiothoracic Transplant and Assist Devices, Baylor College of Medicine, Houston, Texas.

Aortic valve insufficiency can be addressed during continuous-flow 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 patient-years 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.
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http://dx.doi.org/10.1097/MAT.0000000000000856DOI Listing
August 2019

Implantable Ventricular Assist Device Use and Outcomes in People With End-Stage Renal Disease.

J Am Heart Assoc 2018 07 6;7(14). Epub 2018 Jul 6.

Section of Nephrology, Department of Medicine, Selzman Institute for Kidney Health Baylor College of Medicine, Houston, TX.

Background: People with end-stage renal disease (ESRD) are at risk for advanced heart failure, but little is known about use and outcomes of durable mechanical circulatory support in this setting. We examined use and outcomes of implantable ventricular assist devices (VADs) in a national ESRD cohort.

Methods And Results: We performed a retrospective cohort study of Medicare beneficiaries with ESRD who underwent implantable VAD placement from 2006 to 2014. We examined in-hospital and 1-year mortality, all-cause and cause-specific hospitalizations, and heart/kidney transplantation outcomes. We investigated as predictors demographic factors, time-period of VAD implantation, primary or post-cardiotomy implantation, and duration of ESRD before VAD implantation. We identified 96 people with ESRD who underwent implantable VAD placement. At time of VAD implantation, 74 (77.1%) were receiving hemodialysis, 10 (10.4%) were receiving peritoneal dialysis and 12 (12.5%) had renal transplant. Time from incident ESRD to VAD implantation was median 4.0 (interquartile range 1.1, 8.2) years. Mortality during the implantation hospitalization was 40.6%. Within 1 year of implantation 61.5% of people had died. On multivariable analysis, males had half the mortality risk of females. Lower mortality risk was also seen with VAD implantation in a primary setting, and with more recent year of implantation, but these results did not reach statistical significance.

Conclusions: Medicare beneficiaries with ESRD are undergoing durable VAD implantation, often several years after incident ESRD, although in low numbers. Mortality is high among these patients, highlighting the need for investigations to improve treatment selection and management.
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http://dx.doi.org/10.1161/JAHA.118.008664DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6064848PMC
July 2018

Predictive value of preoperative serum albumin levels on outcomes in patients undergoing LVAD implantation.

J Card Surg 2018 Aug 2;33(8):469-478. Epub 2018 Jul 2.

Division of Cardiothoracic Transplant and Assist Devices, Baylor College of Medicine, Houston, Texas.

Background: We performed a single-center retrospective analysis to determine whether preoperative serum albumin levels were associated with postoperative adverse events and short- and long-term survival in patients who underwent continuous-flow left ventricular assist device (CF-LVAD) implantation.

Methods: From November 2003 through March 2016, 526 patients underwent CF-LVAD implantation. Patients whose preoperative serum albumin level was normal (≥3.5 g/dL) were compared to patients with preoperative hypoalbuminemia (<3.5 g/dL), which was further categorized as moderate (2.5-3.5 g/dL) or severe (<2.5 g/dL). These groups were compared regarding preoperative demographics, incidence of postoperative complications, and long-term survival.

Results: Patients with hypoalbuminemia had higher serum levels of liver enzymes (P < 0.05) and total bilirubin (P < 0.001) and significantly lower platelet counts (P = 0.02) and prealbumin levels (P < 0.001) than patients with normal preoperative albumin levels. Survival in patients with moderate and severe preoperative hypoalbuminemia was significantly decreased compared with patients with normal preoperative serum albumin levels (P < 0.001). Preoperative hypoalbuminemia was also associated with higher incidences of postoperative infection, gastrointestinal bleeding, neurological dysfunction, and acute kidney injury (P ≤ 0.01 for all) but did not affect the success of bridge to transplantation or survival after transplantation.

Conclusions: Our data demonstrated that there is a significant association of preoperative low serum albumin levels with postoperative adverse outcomes and lower survival rates. This highlights the importance of a patient's preoperative nutritional status on postoperative outcomes after CF-LVAD implantation.
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http://dx.doi.org/10.1111/jocs.13745DOI Listing
August 2018

Effect of obesity on outcomes in patients who undergo implantation of a continuous-flow left ventricular assist device.

J Artif Organs 2018 09 27;21(3):397. Epub 2018 Jun 27.

Division of Cardiothoracic Transplant and Assist Devices, Baylor College of Medicine, Houston, TX, USA.

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http://dx.doi.org/10.1007/s10047-018-1054-1DOI Listing
September 2018

Long-Term Continuous-Flow Biventricular Support in a 63-Year-Old Woman.

Tex Heart Inst J 2018 04 7;45(2):110-112. Epub 2018 Apr 7.

We describe the successful use of long-term biventricular continuous-flow mechanical circulatory support as a bridge to transplantation in a small-framed 63-year-old woman with long-standing nonischemic cardiomyopathy. After placement of a left-sided HeartWare HVAD, persistent right-sided heart failure necessitated implantation of a second HeartWare device for long-term right ventricular support. After 262 days, the patient underwent successful orthotopic heart transplantation and was discharged from the hospital. This report indicates the feasibility of biventricular device support in older patients of relatively small stature, and our results may encourage others to consider this therapy in similar patient populations.
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http://dx.doi.org/10.14503/THIJ-17-6348DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5940277PMC
April 2018

HeartMate II implantation technique that spares the sternum and ascending aorta.

J Artif Organs 2018 Dec 21;21(4):458-461. Epub 2018 May 21.

Division of Cardiothoracic Transplant and Assist Devices, Baylor College of Medicine, Houston, TX, USA.

Left ventricular assist devices (LVADs) have become the standard therapy for patients with end-stage heart failure, and the use of LVADs for long-term support has grown exponentially over the past decade. As the number of LVAD implantations has increased, surgeons have faced more challenging cases, such as those in which the patient has previously undergone a sternotomy. The HeartMate II is one of the most widely implanted LVADs. The standard procedure for HeartMate II implantation is median sternotomy and sewing the outflow graft to the ascending aorta. However, in patients with sternal comorbidities, it can be advantageous to use a less invasive approach that avoids this procedure. We describe the case of a 64-year-old man with a history of end-stage ischemic cardiomyopathy who had previously undergone a median sternotomy and a coronary artery bypass grafting operation and had patent grafts. He required a HeartMate II LVAD (destination therapy), which was implanted via a left subcostal incision; the pump was placed subdiaphragmatically, and the outflow graft was sewed to the descending aorta to avoid a complicated redo cardiac operation via median sternotomy and to minimize the risk of injuring the patent bypass grafts. The patient survived for more than 500 days postoperatively. This approach is feasible and could be a safer method for implanting a HeartMate II device in patients with serious comorbidities that preclude the use of the traditional implantation techniques.
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http://dx.doi.org/10.1007/s10047-018-1049-yDOI Listing
December 2018

Acute kidney injury after implantation of a left ventricular assist device: a comparison of axial-flow (HeartMate II) and centrifugal-flow (HeartWare HVAD) devices.

J Artif Organs 2018 Sep 15;21(3):285-292. Epub 2018 May 15.

Division of Cardiothoracic Transplantation and Circulatory Support, Baylor College of Medicine, 6720 Bertner Ave., Houston, TX, 77030, USA.

Continuous-flow left ventricular assist devices (CF-LVADs) are increasingly being used to treat advanced, refractory chronic heart failure. Herein, we sought to determine the incidence of postoperative acute kidney injury (AKI) in axial-flow (HeartMate II; HM-II) and centrifugal-flow (HVAD) CF-LVAD recipients, as well as the effect of AKI on mortality. The study cohort comprised 520 patients who received a HM-II (n = 398) or HVAD (n = 122) at our center between November 2003 and March 2016. Their records were reviewed to determine the incidence of RIFLE-defined AKI after LVAD implantation. We compared the perioperative characteristics, postoperative complications, and survival rates of the patients with and without AKI and differentiated the outcomes based on device type (HM-II or HVAD). Seventy-five patients (14.4%) developed AKI postoperatively. Patients with AKI after LVAD implantation had significantly reduced survival compared to patients without AKI (p = 0.01). Cox proportional hazards models showed that AKI was a significant independent predictor of mortality (HR = 1.54, p = 0.03). Preoperative mechanical circulatory support and prolonged cardiopulmonary bypass time were independent predictors of AKI. The incidence of AKI was similar for HM-II and HVAD recipients (p = 0.25). There was no significant difference in AKI rates for the HM-II and HVAD recipients. Developing AKI adversely affected survival.
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http://dx.doi.org/10.1007/s10047-018-1047-0DOI Listing
September 2018

Model of End-Stage Liver Disease-eXcluding International Normalized Ratio (MELD-XI) Scoring System to Predict Outcomes in Patients Who Undergo Left Ventricular Assist Device Implantation.

Ann Thorac Surg 2018 08 4;106(2):513-519. Epub 2018 Apr 4.

Division of Cardiothoracic Transplant and Assist Devices, Baylor College of Medicine, Houston, Texas; Department of Cardiopulmonary Transplantation and the Center for Cardiac Support, Texas Heart Institute, Houston, Texas.

Background: The use of continuous-flow left ventricular assist devices (CF-LVADs) to treat advanced heart failure is increasing. Although risk scores, such as Model for End-Stage Liver Disease and the HeartMate II Risk Score, require the use of the international normalized ratio, many patients are on anticoagulation before CF-LVAD implantation. This study evaluated the ability of the Model of End-Stage Liver Disease-eXcluding International Normalized Ratio (MELD-XI) scoring system to predict clinical outcomes in patients with advanced heart failure who undergo CF-LVAD implantation.

Methods: A single-center retrospective review was performed of 524 patients who were implanted with the HeartMate II LVAD (Thoratec Corporation, Pleasanton, CA) or the HeartWare HVAD (HeartWare International Inc, Framingham, MA) between 2004 and 2016. Patients were stratified into two cohorts: those with a MELD-XI score of less than 14 (n = 301) and 14 or higher (n = 223).

Results: Patients with the higher-risk MELD-XI score of 14 or higher demonstrated lower survival rates at 1, 3, 6, 12, and 24 months (p < 0.001 for all) and increased risk of early right heart failure and infections compared with patients with MELD-XI score of less than 14. MELD-XI was not significantly inferior at predicting 90-day mortality compared with the HeartMate II Risk Score (p = 0.92). Patients with elevated MELD-XI scores at follow-up demonstrated higher rates of mortality.

Conclusions: These findings suggest that a MELD-XI score of 14 or higher was associated with a higher postoperative mortality rate than that seen in patients with a lower MELD-XI score. The MELD-XI scoring system can be used to predict outcomes in patients with advanced heart failure who undergo CF-LVAD implantation.
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http://dx.doi.org/10.1016/j.athoracsur.2018.02.082DOI Listing
August 2018