Clinical Experience With HeartWare Left Ventricular Assist Device in Patients With End-Stage Heart Failure

doi:10.1016/j.athoracsur.2011.11.076

The Annals of Thoracic Surgery

Volume 93, Issue 3, March 2012, Pages 810-815

https://doi.org/10.1016/j.athoracsur.2011.11.076 Get rights and content

Background

The gold standard treatment for end-stage heart failure is cardiac transplantation. Because of the increasing number of heart failure patients and the limited supply of donor hearts, a ventricular assist device (VAD) is used as a bridge to transplantation, recovery, or decision. Newer generation VADs have lower risk of fatal adverse events and are also smaller in size. We present our experience with the intrapericardial HeartWare VAD (HeartWare, Framingham, MA) and its clinical outcome.

Methods

The clinical outcome of HeartWare VAD implantations for end-stage heart failure patients performed at Harefield Hospital from March 2007 to June 2011 was studied. The study design was a retrospective review of the prospectively collected data.

Results

Thirty-four patients with a mean age of 51 ± 10 years were included in this study. Twenty-nine patients were male (85%). The mean duration of mechanical support was 261 ± 64 days. Five patients (15%) were successfully bridged to heart transplantation. The overall mortality was 24% (8 patients). There were 1 case of mechanical device failure (2%) and 3 cases of device failure due to thrombus formation (8%). Postoperative complications included 5 reoperations for bleeding (15%), 12 acute renal failures (36%), 7 respiratory failures (21%), 2 hepatic dysfunctions (6%), 3 neurologic dysfunctions (9%), 7 right-side heart failures (21%), and 5 driveline infections (15%).

Conclusions

Although cardiac transplantation remains the gold standard for treatment of end-stage heart failure patients, the HeartWare VAD can be used as a safe alternative with a satisfactory clinical outcome.

Section snippets

Study Population

All HW implantations due to end-stage heart failure refractory to medical treatment, performed at Harefield Hospital from March 2007 to June 2011 were included in this study. Data were collected prospectively as part of Harefield Hospital VAD surgery database collection. The Harefield Hospital database includes detailed information about patient demographics, preoperative risk factors, operative details, postoperative hospital course, morbidity, and mortality. This data collection is part of

Perioperative Outcome

There was no perioperative mortality after HW implantation. Four cases had a simultaneous temporary right ventricular assist device implantation in addition to their HW implantation due to right-side heart failure. Another 4 cases had a combined procedure with HW implantation (tricuspid valve repair, aortic valve replacement, closure of atrial septal defect, closure of patent foramen ovale).

The operation was performed through median sternotomy with cardiopulmonary bypass. The mean

Comment

Although heart transplantation remains the gold standard treatment for end-stage heart failure, owing to the shortage of donor organs, VADs are playing an increasingly important role in the management of heart failure patients. These devices have proved to be an excellent treatment option for patients with end-stage heart failure and for those awaiting cardiac transplantation. They significantly improve the survival and the quality of life [1, 4].

The HW LVAD is a miniaturized centrifugal blood

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Cited by (64)

A Bayesian Model to Predict Survival After Left Ventricular Assist Device Implantation
2018, JACC: Heart Failure
This study investigates the use of a Bayesian statistical models to predict survival at various time points in patients undergoing left ventricular assist device (LVAD) implantation.
LVADs are being increasingly used in patients with end-stage heart failure. Appropriate patient selection continues to be key in optimizing post-LVAD outcomes.
Data used for this study were derived from 10,277 adult patients from the INTERMACS (Inter-Agency Registry for Mechanically Assisted Circulatory Support) who had a primary LVAD implanted between January 2012 and December 2015. Risk for mortality was calculated retrospectively for various time points (1, 3, and 12 months) after LVAD implantation, using multiple pre-implantation variables. For each of these endpoints, a separate tree-augmented naïve Bayes model was constructed using the most predictive variables.
A set of 29, 26, and 31 pre-LVAD variables were found to be predictive at 1, 3, and 12 months, respectively. Predictors of 1-month mortality included low Inter-Agency Registry for Mechanically Assisted Circulatory Support profile, number of acute events in the 48 h before surgery, temporary mechanical circulatory support, and renal and hepatic dysfunction. Variables predicting 12-month mortality included advanced age, frailty, device strategy, and chronic renal disease. The accuracy of all Bayesian models was between 76% and 87%, with an area under the receiver operative characteristics curve of between 0.70 and 0.71.
A Bayesian prognostic model for predicting survival based on the comprehensive INTERMACS registry provided highly accurate predictions of mortality based on pre-operative variables. These models may facilitate clinical decision-making while screening candidates for LVAD therapy.
Percutaneous and transcutaneous connections
2018, Mechanical Circulatory and Respiratory Support
Device-related infection is one of the major complications of mechanical circulatory support (MCS) and hinders long-term MCS success. Biofilm formation and migration are important strategies of microorganisms in the pathogenesis and persistence of MCS device infections. Biofilm formation provides a shield against antimicrobials and human immune responses, and biofilm migration further extends the infections to deeper tissues. Replacement of infected MCS devices, such as ventricular assist devices or extracorporeal membrane oxygenation, is associated with significant morbidity and mortality, underscoring the importance of developing preventative strategies for MCS device infections. Such strategies include optimizing the design of MCS devices to increase its tissue integration and developing antiinfective coatings for the device surfaces. Replacing the percutaneous device cable with wireless energy transfer systems is considered an ultimate solution for these infections. Thus, transcutaneous energy supply systems, an “infection-free” power supply for MCS, are now under development.
Longitudinal changes in hemostatic parameters and reduced pulsatility contribute to non-surgical bleeding in patients with centrifugal continuous-flow left ventricular assist devices
2016, Journal of Heart and Lung Transplantation
Bleeding and thromboembolic events are identified complications in patients supported with newer centrifugal continuous-flow left ventricular assist devices (cfLVADs). Bleeding events have been associated with acquired von Willebrand syndrome (vWS) in these patients, though longitudinal changes and the effect of pulsatility remain unquantified. We evaluated longitudinal effects of third-generation cfLVADs on hemostatic biomarkers, non-surgical bleeding, and thromboembolic events. We investigated the association between pulsatility (as defined by aortic valve opening) on von Willebrand Factor (VWF) profile and bleeding.
We prospectively studied 28 patients implanted with the HeartWare (HeartWare International, Framingham, MA) cfLVAD for up to 360 days. We performed bleeding and coagulation assays 8 times from pre-implant to Day 360 (D360) post-implant, including platelet aggregometry, VWF collagen binding activity-to-antigen (CBA/Ag) ratio, thromboelastography, soluble P-selectin, platelet-specific marker soluble glycoprotein VI (sGPVI), and platelet microparticles. Aortic valve opening was assessed by echocardiography at each assessment. Bleeding and thromboembolic events were documented.
Bleeding events occurred in 14 patients (50%). Maximal platelet inhibition occurred by D30. VWF profile impairment (VWF CBA/Ag < 0.8) was demonstrated in 89% of patients at D30, with subsequent recovery but further deterioration after D180. Bleeding was associated with elevated pre-implant sGPVI (p = 0.008). Pulsatility was associated with higher VWF CBA/Ag (p = 0.02) and a trend to less bleeding.
Third-generation cfLVADs were associated with longitudinal changes in hemostatic markers, and bleeding was associated with elevated pre-implant plasma sGPVI. Further, pulsatility may contribute to recovery of the VWF profile and potentially lower bleeding risk.
Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF A Multicenter Study
2015, Journal of the American College of Cardiology
Citation Excerpt :
This first clinical study with this new centrifugal-flow chronic LVAS has successfully demonstrated the safety and performance of this device in an advanced HF population (Central Illustration), including patients requiring BTT or DT under a single set of entry criteria. Survival rates of 98% at 30 days and 92% at 6 months compare well with the reported survival in prior studies involving BTT or DT indications (1,3,21–31). Additionally, compared with an SHFM-predicted 6-month survival of 78%, support with this new device was associated with a mortality risk reduction of 66%.
The HeartMate 3 left ventricular assist system (LVAS) is intended to provide long-term support to patients with advanced heart failure. The centrifugal flow pump is designed for enhanced hemocompatibility by incorporating a magnetically levitated rotor with wide blood-flow paths and an artificial pulse.
The aim of this single-arm, prospective, multicenter study was to evaluate the performance and safety of this LVAS.
The primary endpoint was 6-month survival compared with INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support)-derived performance goal. Patients were adults with ejection fraction ≤25%, cardiac index ≤2.2 l/min/m² without inotropes or were inotrope-dependent on optimal medical management, or listed for transplant.
Fifty patients were enrolled at 10 centers. The indications for LVAS support were bridge to transplantation (54%) or destination therapy (46%). At 6 months, 88% of patients continued on support, 4% received transplants, and 8% died. Thirty-day mortality was 2% and 6-month survival 92%, which exceeded the 88% performance goal. Support with the fully magnetically levitated LVAS significantly reduced mortality risk by 66% compared with the Seattle Heart Failure Model–predicted survival of 78% (p = 0.0093). Key adverse events included reoperation for bleeding (14%), driveline infection (10%), gastrointestinal bleeding (8%), and debilitating stroke (modified Rankin Score >3) (8%). There were no pump exchanges, pump malfunctions, pump thrombosis, or hemolysis events. New York Heart Association classification, 6-min walk test, and quality-of-life scores showed progressive and sustained improvement.
The results show that the fully magnetically levitated centrifugal-flow chronic LVAS is safe, with high 30-day and 6-month survival rates, a favorable adverse event profile, and improved quality of life and functional status. (HeartMate 3™ CE Mark Clinical Investigation Plan [HM3 CE Mark]; NCT02170363)
Long-term outcome of heart transplantation performed after ventricular assist device compared with standard heart transplantation
2019, Archives of Cardiovascular Diseases
Citation Excerpt :
It was conducted recently, and only included patients since 2005; this was because post-transplantation ECMO was used routinely from that time. Moreover, it also corresponds to the emergence and validation of implantable continuous-flow LVAD devices, such as HeartMate II® [30] and HeartWare® [5,18,31,32], for long-term circulatory support. Over the past decade, dramatic improvements have been made in terms of circulatory assist devices and surgical techniques for performing heart transplantation, as well as in device implantation and the management of patients immediately after the operation and during long-term follow-up.
Data on the long-term outcome of heart transplantation in patients with a ventricular assist device (VAD) are scarce.
To evaluate long-term outcome after heart transplantation in patients with a VAD compared with no mechanical circulatory support.
Consecutive all-comers who underwent heart transplantation were included at a single high-volume centre from January 2005 until December 2012, with 5 years of follow-up. Clinical and biological characteristics, operative results, outcomes and survival were recorded. Regression analyses were performed to determine predictors of 1-year and 5-year mortality.
Fifty-two patients with bridge to transplantation by VAD (VAD group) and 289 patients transplanted without a VAD (standard group) were enrolled. The mean age was 46 ± 11 years in the VAD group compared with 51 ± 13 years in the standard group (P = 0.01); 17% of the VAD group and 25% of the standard group were women (P = 0.21). Ischaemic time was longer in the VAD group (207 ± 54 vs 169 ± 60 minutes; P < 0.01). There was no difference in primary graft failure (33% vs 25%; P = 0.22) or 1-year mortality (17% vs 28%; P = 0.12). In the multivariable analysis, preoperative VAD was an independent protective factor for 1-year mortality (odds ratio 0.40, 95% confidence interval 0.17–0.97; P = 0.04). Independent risk factors for 1-year mortality were recipient age > 60 years, recipient creatinine, body surface area mismatch and ischaemic time. The VAD and standard groups had similar long-term survival, with 5-year mortality rates of 35% and 40%, respectively (P = 0.72).
Bridge to transplantation by VAD was associated with a reduction in 1-year mortality, leading critically ill patients to similar long-term survival compared with patients who underwent standard heart transplantation. This alternative strategy may benefit carefully selected patients.
Peu de données sont disponibles concernant le devenir des patients transplantés après l’implantation d’un dispositif d’assistance ventriculaire (DAV).
Évaluer le devenir à long terme après transplantation cardiaque des patients implantés d’un DAV, comparativement aux patients transplantés sans dispositif.
Tous les patients consécutifs qui ont bénéficié d’une transplantation cardiaque entre janvier 2005 et décembre 2012 ont été inclus au sein d’un unique centre à haut volume, avec un suivi de 5 ans. Les caractéristiques cliniques, biologiques, les résultats opératoires, le devenir et la mortalité totale ont été relevés. Des analyses de régression ont été effectuées pour déterminer les facteurs prédictifs de mortalité à 1 et 5 ans.
Cinquante-deux patients « DAV » et 289 patients « standards » transplantés sans DAV ont été inclus. L’âge moyen était de 46 ± 11 ans dans le groupe DAV vs 51 ± 13 ans dans le groupe standard (p = 0,01) et 17% des patients DAV étaient de sexe féminin vs 25% (p = 0,21). Le temps d’ischémie froide était plus long dans le groupe DAV (207 ± 54 vs 169 ± 60 min, p < 0,01). Il n’y avait pas de différence de défaillance primaire du greffon (33% vs 25%, p = 0,22) ou de mortalité à 1 an (17% vs 28%, p = 0,12). Le DAV pré-transplantation était un facteur protecteur indépendant de mortalité à 1 an (OR 0,40 [0,17-0,97], p = 0,04). Les facteurs de risque indépendants de mortalité à 1 an étaient l’âge du receveur>60 ans, la créatinine de receveur, le mismatch de surface corporelle et la durée d’ischémie. Les patients DAV et standards avaient une survie à long terme similaire, avec une mortalité à 5 ans respectivement de 35% et 40% (p = 0,72).
Le pont vers la transplantation par un DAV était associé à une réduction de la mortalité à 1 an, conduisant les patients les plus critiques à une survie à long terme comparable à celle des patients transplantés de façon standard. Cette stratégie alternative est susceptible de bénéficier à une population de patients sélectionnés.
Is it safe for patients with left ventricular assist devices to undergo non-cardiac surgery?
2020, Medicina (Lithuania)

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Original articleAdult cardiacClinical Experience With HeartWare Left Ventricular Assist Device in Patients With End-Stage Heart Failure

Background

Methods

Results

Conclusions

Section snippets

Study Population

Perioperative Outcome

Comment

J Am Coll Cardiol

Ann Thorac Surg

J Heart Lung Transplant

J Am Coll Cardiol

J Heart Lung Transplant

J Thorac Cardiovasc Surg

Original article
Adult cardiac
Clinical Experience With HeartWare Left Ventricular Assist Device in Patients With End-Stage Heart Failure