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Objective: Ventricular assist device is one of the treatment options for heart failure patients. Therefore, the purpose of this review is to aid in clinical decision-making of exchanging previous older ventricular assist device models to the newest one, HM3. Methods: The search was conducted across several databases until February 25, 2023, and was registered with the ID of CRD42023405367. Risk of bias was performed using Cochrane Risk of Bias 2.0 and the Newcastle Ottawa Scale. In order to rank and evaluate the pooled odds ratios and mean differences with 95% confidence intervals, we employed conventional and Bayesian network meta-analysis converted to surface under the cumulative ranking. Results: A total of 49 studies with 31,105 patients were included in this review. HM3 is the best device exchange choice that causes the lowest risk of mortality (HM3 (99.98) > HM2 (32.43) > HVAD (17.58)), cerebrovascular accidents (HM3 (99.99) > HM2 (42.41) > HVAD (7.60)), other neurologic events beside cerebrovascular accident (HM3 (91.45) > HM2 (54.16) > HVAD (4.39)), pump thrombosis (HM3 (100.00) > HM2 (39.20) > HVAD (10.80)), and bleeding (HM3 (97.12) > HM2 (47.60) > HVAD (5.28)). HM3 is also better than HM2 in hospital admissions (OR: 1.90 (95% CI: 1.15-3.12)). When complications were present, HM2 or Heartware ventricular assist devices exchange to HM3 lowered the mortality rate compared to exchanging it to the same device type. Conclusion: HM3 is the best device for all six outcomes. Exchange from Heartware ventricular assist devices or HM2 to HM3 rather than the same ventricular assist device type is recommended only if a complication is present.

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Introduction: While the exchange of a superior valved glaucoma drainage device (GDD) for a non-valved GDD has been reported for achieving glaucoma control, inferior GDD exchange for improving the cosmetic appearance of the eyes due to poor appearance caused by encapsulated GDDs has not been previously documented. Here, we report on two patients with inferior valved GDDs who underwent an exchange for non-valved devices for glaucoma control and cosmetic improvement. Case description: We report on the case of a 23-year-old gentleman and that of an 8-year-old girl, both of whom had inferior valved GDDs with uncontrolled intraocular pressure and unsightly appearance due to encapsulated GDD plates within the palpebral aperture. Both patients were unhappy about the appearance of their eyes. In each case, improvements in both glaucoma control and cosmesis were achieved by exchanging the valved GDDs for non-valved ones. Conclusion: Exchanging a valved for a non-valved GDD might help improve the cosmetic appearance of the eyes, in addition to providing glaucoma control.

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OBJECTIVE: Among left ventricular assist device patients, the most commonly infected component is the drive line, which can be managed with antibiotics and local debridement. Infection of intrathoracic device components is less common but more difficult to manage. Herein we describe the incidence of deep device infection (DDI) at our center as well as management and outcomes. METHODS: We retrospectively reviewed 658 patients who underwent implantable left ventricular assist device insertion with HeartMate 2 (Abbott) or HeartMate 3 (Abbott) devices between January 2004 and June 2021. DDI was defined according to radiographic and clinical criteria. Cumulative incidence was calculated using a Fine-Gray subdistribution model; survival analysis was performed using the method of Kaplan and Meier. RESULTS: There were 32 (4.8%) DDIs during this study period. Drive line infection and re-exploration for bleeding were associated with development of DDI. Cumulative incidence of DDI increased over time, affecting 11% (7%-18%) at 5 years. The dominant microbes involved in DDI were Pseudomonas aeruginosa (19%) and methicillin-resistant Staphylococcus aureus (13%). Nineteen patients (59%) with device infection underwent device exchange, 6 (19%) underwent initial transplant, and 7 (22%) were treated solely with debridement and antibiotics. Of those who underwent device exchange, 12 (63%) developed reinfection of their new device and 6 underwent subsequent heart transplant. Patients who underwent transplantation for management of device infection had improved 5-year survival (80% vs 11%; P = .01) but 3 patients (25%) developed deep sternal wound infection after transplant. CONCLUSIONS: DDI is a rare but challenging complication in this destination era. Heart transplantation is the preferred management strategy for eligible patients but infectious complication is common.

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BACKGROUND: The new heart transplant allocation criteria prioritize inpatients who require temporary mechanical circulatory support and give lower urgency to candidates on a durable left ventricular assist device (LVAD) who require a device exchange. This study explores whether the latter group should warrant higher priority to reduce wait-list mortality. METHODS: This is a retrospective observational study of 13,113 adult heart transplant candidates in the Organ Procurement and Transplantation Network database who underwent LVAD implantation between 2007 and 2017. It evaluates the impact of LVAD exchange on the composite endpoint of death or removal from the wait list owing to worsening medical condition 1 y after device implantation. RESULTS: There were 1085 pump exchanges in 954 patients (7% of candidates), of which 22% were women. The pump exchange rate was 5.92 events per 100 patient-years. One-year survival was lower for those who required a pump exchange (76.3% versus 88.5%, logrank P < 0.001). This was congruent with the risk-adjusted mortality 1-y after implantation (hazards ratio: 2.56, 95% confidence interval: 2.18-3.00, P < 0.001). CONCLUSIONS: These findings indicate that among candidates awaiting heart transplantation with a durable LVAD, undergoing pump exchange doubles the risk of 1-y mortality. Giving priority to these candidates may reduce wait-list mortality.

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The purpose of this study is to compare clinical outcomes of left ventricular assist device (LVAD) patients with device thrombosis who underwent device exchange (DE) or medical therapy (MT) alone. Consecutive patients undergoing LVAD implant between July 2008 and December 2017 were included. Device thrombosis was diagnosed with comprehensive assessments including ramp test, laboratory data, device parameters, and clinical presentations. First, MT was initiated in all patients. After MT, DE was considered if device thrombosis was refractory to initial MT, and it caused end-organ impairment and/or hemodynamic instability. Among 319 consecutive LVAD patients, 43 patients (13.5%) were diagnosed with device thrombosis. DE was performed in 28 patients (DE group); device explant was performed in 1 patient. MT was continued in 14 patients (MT group). In-hospital mortality was significantly lower in the DE group than the MT group (3.6% [1/28] vs. 28.6% [4/14], P = .0184). One-year survival was significantly better in the DE group (74.0% vs. 30.1%; log-rank = .001), and freedom from cerebrovascular accident (CVA) at 1 year was greater in the DE group (87.1% vs. 47.7%; log-rank = .004). DE was associated with improved 1-year survival and fewer CVAs. Surgical intervention, if feasible, is recommended for LVAD device thrombosis.

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This is a single-center retrospective study to summarize clinical outcomes of patients requiring surgical continuous-flow left ventricular assist device (HeartMate II) exchange. The patients who underwent HeartMate II exchange were divided into two groups either via a subcostal approach (SC group) or a full sternotomy (FS group). The exclusion criteria of a subcostal approach for device exchange included the presence of outflow graft obstruction, and/or the need for concomitant cardiac procedures. Among 277 consecutive patients who underwent HeartMate II implantation from July 2008 to December 2015, 25 patients (9.0%) required device exchange (SC group; N = 13, FS group; N = 12). The SC group, compared to the FS group, had a shorter operative time (200.6 ± 31.4 min vs 534.2 ± 123.9 min; P < 0.001), shorter cardiopulmonary bypass time (33.1 ± 22.0 min vs 151.5 ± 53.1 min; P < 0.001), fewer blood transfusion (0.31 ± 0.48 units vs 4.67 ± 3.65 units; P = 0.002). The SC group had lower incidence of postoperative prolonged intubation (> 24 h) (7.7% vs 90.9%, P < 0.001), tracheostomy (0.0% vs 41.7%, P = 0.015), acute kidney injury requiring dialysis (0.0% vs 33.3%, P = 0.039). In-hospital mortality was 0.0% (0/13) in the SC group and 16.7% (2/12) in the FS group (P = 0.220). In conclusion, a subcostal approach was associated with shorter operative time, fewer blood transfusions, and less postoperative complications, compared to full sternotomy. A subcostal approach, if feasible, is preferred for HeartMate II device exchange.

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The most common technical complication during ECMO is clot formation. A large clot inside a membrane oxygenator reduces effective membrane surface area and therefore gas transfer capabilities, and restricts blood flow through the device, resulting in an increased membrane oxygenator pressure drop (dpMO). The reasons for thrombotic events are manifold and highly patient specific. Thrombus formation inside the oxygenator during ECMO is usually unpredictable and remains an unsolved problem. Clot sizes and positions are well documented in literature for the Maquet Quadrox-i Adult oxygenator based on CT data extracted from devices after patient treatment. Based on this data, the present study was designed to investigate the effects of large clots on purely technical parameters, for example, dpMO and gas transfer. Therefore, medical grade silicone was injected into the fiber bundle of the devices to replicate large clot positions and sizes. A total of six devices were tested in vitro with silicone clot volumes of 0, 30, 40, 50, 65, and 85 mL in accordance with ISO 7199. Gas transfer was measured by sampling blood pre and post device, as well as by sampling the exhaust gas at the devices' outlet at blood flow rates of 0.5, 2.5, and 5.0 L/min. Pre and post device pressure was monitored to calculate the dpMO at the different blood flow rates. The dpMO was found to be a reliable parameter to indicate a large clot only in already advanced "clotting stages." The CO2 concentration in the exhaust gas, however, was found to be sensitive to even small clot sizes and at low blood flows. Exhaust gas CO2 concentration can be monitored continuously and without any risks for the patient during ECMO therapy to provide additional information on the endurance of the oxygenator. This may help detect a clot formation and growth inside a membrane oxygenator during ECMO even if the increase in dpMO remains moderate.

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BACKGROUND: Pump thrombosis is a major adverse event in patients supported with a left ventricular assist device (LVAD). Treatment approaches include device exchange, lytic therapy, or augmentation of anticoagulation or antiplatelet therapy. The optimal strategy in the HeartWare HVAD Ventricular Assist System (HeartWare, Framingham, MA) is uncertain, and because few large studies have examined differing treatment outcomes, we have reviewed findings from the Mechanical Circulatory Support Research Network registry. METHODS: Between March 2009 and August 2014, 175 patients (133 male) underwent implantation of the HeartWare HVAD at institutions that comprise the Mechanical Circulatory Support Research Network. Median age at implant was 59 years (range, 18-76 years). Follow-up was available in all patients for a median of 6 months (maximum, 61 months) and for a total of 163 patient-years of support. There were 36 pump thromboses (using Interagency Registry for Mechanically Assisted Circulatory Support criteria) in 21 patients for a total event rate of 0.22 events/patient-year of support; 13 patients had 1 event, 4 had 2, 2 had 3, 1 had 4, and 1 had 5. The median time to the first thrombosis was 6.4 months, and to each subsequent thrombosis was 4, 3, 2, and 2 months, respectively. Primary treatment success was defined as the patient remaining alive and within the first 30 days of the initial treatment be free from stroke, recurrence of pump thrombosis, device exchange, or urgent transplantation (United Network of Organ Sharing Status 1A). Medical treatment was defined as tissue plasminogen activator, heparin plus glycoprotein IIb/IIIa inhibitor, or heparin alone, not followed by surgical treatment within 72 hours. RESULTS: Initial medical treatment was used in 29 episodes (tissue plasminogen activator in 24, heparin alone in 4, and heparin plus glycoprotein IIb/IIIa in 1) and surgical (device exchange) in 7. Medical treatment was successful in 14 of 29 episodes (48%). Complications of medical treatment included hemorrhagic stroke in 6 patients (21%), need for urgent device exchange/transplant in 6 (21%), and death in 3 (10%). Surgical treatment was successful in all 7 patients (100%). No significant early complications or early deaths occurred after device exchange. CONCLUSIONS: In this large multicenter analysis, we observed that medical therapy, as the initial treatment strategy for HeartWare HVAD thrombosis, is associated with low success (48%) and a significant risk of hemorrhagic stroke (21%) and death (10%). However, initial treatment with device exchange was uniformly successful and not associated with significant early morbidity or death. Although the optimal treatment approach for HeartWare HVAD pump thrombosis remains undecided, these data do not support the routine use of medical therapy as an initial treatment strategy.

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AIMS: The approach to infected cardiac devices has changed during recent decades. Optimal treatment is still a matter of debate, especially in pacemaker-dependent patients. Therefore, we investigated the management and outcome of patients with pacemaker infections in a single centre over four decades. METHODS AND RESULTS: We conducted a retrospective analysis of 4212 patients and extracted those with pacemaker infections admitted to Rostock Heart Center between 1973 and 2012. One hundred and thirty-one consecutive patients (median age 69.6 ± 14.9 years) were admitted for device infections. Two-stage exchange was performed in 42 patients (32.8%). In 72 patients (55%), explantation and implantation on the contralateral side was performed simultaneously. In 17 cases the device was not replaced. Mean follow-up was 63 ± 81 months. Reinfection rate was 12.2%, which declined from 24% (1980s) to 2.6% (after 2000). Complete device removal (in 57.3%) reduced the risk for reinfection by 75% (P = 0.02), as well as increasing age (0.049% per year, P = 0.001). One-stage exchange increased the risk of reinfection six-fold (P = 0.021). Cultured bacteria after initiation of antibiotic therapy predicted a four-fold increase in risk of a recurrent infection (P = 0.01). CONCLUSION: Continuous assimilation of guidelines for pacemaker infection improved the outcome over time: complete extraction of the infected device seems to be highly desirable. A one-stage exchange increased the risk of recurrent device infection and should probably be avoided, but complete extraction seems to be more important than timing.

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BACKGROUND: A percentage of patients with a left ventricular assist device (LVAD) require device exchange. Although this is an important clinical entity, there are only a handful of relevant studies on this topic in the literature. METHODS: From 2004 to 2012, 30 device exchanges (HeartMate II to HeartMate II) were performed. Since June 2011, we have employed the subcostal approach for device exchange if indicated. Sixteen patients underwent device exchange through a subcostal approach (S group), whereas 14 patients had devices exchanged through a full sternotomy (F group). Pre- and post-operative data were retrospectively reviewed. RESULTS: There was no difference in baseline patient characteristics between the two groups. Overall, mean duration between primary surgery and device exchange was 425 ± 407 days. Surgical indications included device thrombus/hemolysis (N = 19), device malfunction (N = 9) and infection (N = 2). Cardiopulmonary bypass time was significantly shorter in the S group (S: 40 ± 23 minutes, F: 105 ± 84 minutes; p < 0.05), and post-operative bleeding within 24 hours after surgery was less in the S group (S: 362 ± 367 ml, F: 1,286 ± 971 ml; p < 0.05). Length of ICU stay was significantly shorter in the S group (S: 4.6 ± 1.8 days, F: 8.2 ± 4.9 days; p < 0.05). There was no difference in post-operative complications, except for prolonged intubation (F: N = 6 [43%], S: N = 1 [6.3%]; p < 0.05). There were 3 deaths in the F group and 0 in the S group, with no statistical difference (p = 0.09). Also, there was no significant difference in other outcomes, including transplantation, device explantation and ongoing LVAD support. CONCLUSIONS: A subcostal approach may be preferred for HeartMate II device exchange if indicated.

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