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OBJECTIVES: Left Ventricular Assist Device (LVAD) therapy has evolved from a short-term bridge-to-transplant strategy into a long-term and often chronic therapy due to long waiting times for heart transplantation and application as destination therapy. Consequently, patients are at risk of developing complications necessitating LVAD exchange. The aim of this study is to assess patient outcome after LVAD exchange. METHODS: Patients who underwent LVAD exchange between January 2010 and December 2022 were included. Logistic and cox regression analyses were used to identify potential risk factors for short and long-term adverse events, respectively. Survival after exchange was assessed using Kaplan-Meier estimates. RESULTS: Sixty-one patients underwent a total of 80 LVAD exchanges. Most frequently observed short-term complications were pulmonary infections (16.3%) and right heart failure (16.3%). Exit-site infections (34.7%) and device malfunctions (25.3%) were the most often observed long-term complications. HeartWare Ventricular Assist Device (HVAD) as index device was associated with a higher risk of right heart failure (HR 6.42, 95% CI 1.80-22.90) and respiratory failure (HR 7.81, 95% CI 1.95-31.23) compared to HeartMate II and HeartMate 3. Survival was 83% (95% CI 75.5%-95.3%) at one year and 67% (95% CI 53.9%-84.7%) at six years after exchange. After five years, 25.0% was transplanted, 23.8% had undergone a re-exchange and 32.5% was alive without new intervention. CONCLUSIONS: Although LVAD exchange can be performed with a relatively low mortality, other post-operative adverse events are common. Patients with the HVAD as index device may be at higher risk of developing right heart failure and respiratory failure after exchange.

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AIMS: Subcutaneous implantable cardioverter-defibrillators (S-ICDs) offer potentially distinct advantages over transvenous defibrillator systems. Recent randomized trials showed significantly lower lead failure rates than transvenous ICD. Still, S-ICDs remain associated with the risk of inappropriate shocks (IAS). While previous studies have reported varying causes of IAS, this study explores a rare cause of IAS, referred to as 'sense-B-noise.' It was recently described in case series, but its incidence has not been studied in a large cohort of S-ICD patients. METHODS AND RESULTS: We retrospectively reviewed data from patients implanted with S-ICD models 1010, A209, and A219 between October 2009 and July 2023 across nine centres in Europe and the USA. The analysis concentrated on determining the incidence and understanding the implications of sense-B-noise events. Sense-B-noise represents a rare manifestation of distinct electrogram abnormalities within the primary and alternate sensing vectors. Data were collected from medical records, device telemetry, and manufacturer reports for investigation. This registry is registered on clinicaltrials.gov (NCT05713708). Subcutaneous implantable cardioverter-defibrillator devices of the 1158 patients were analysed. The median follow-up time for all patients was 46 (IQR 23-64) months. In 107 patients (9.2%) ≥1 IAS was observed during follow-up. Sense-B-noise failure was diagnosed in six (0.5 and 5.6% of all IAS) patients, in all patients, the diagnosis was made after an IAS episode. Median lead dwell time in the affected patients was 23 (2-70) months. To resolve the sense-B-noise defect, in three patients reprogramming to the secondary vector was undertaken, and two patients underwent system removal with subsequent S-ICD reimplantation due to low amplitude in the secondary vector. In one patient, the secondary vector was initially programmed, and subsequently, an S-ICD system exchange was performed due to T-wave-oversensing IAS episodes. CONCLUSION: This multicentre analysis' findings shed light on a rare but clinically highly significant adverse event in S-ICD therapy. To our knowledge, we provide the first systematic multicentre analysis investigating the incidence of sense-B-noise. Due to being difficult to diagnose and limited options for resolution, management of sense-B-noise is challenging. Complete system exchange may be the only option for some patients. Educating healthcare providers involved in S-ICD patient care is crucial for ensuring accurate diagnosis and effective management of sense-B-noise issues.

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AIMS: Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have become established in preventing sudden cardiac death, with some advantages over transvenous defibrillator systems, including a lower incidence of lead failures. Despite technological advancements, S-ICD carriers may suffer from significant complications, such as premature battery depletion (PBD), that led to an advisory for nearly 40 000 patients. This multicentre study evaluated the incidence of PBD in a large set of S-ICD patients. METHODS AND RESULTS: Data from patients implanted with S-ICD models A209 and A219 between October 2012 and July 2023 across nine centres in Europe and the USA were reviewed. Incidence and implications of PBD, defined as clinically observed sudden drop in battery longevity, were analysed and compared to PBD with the definition of battery depletion within 60 months. Prospectively collected clinical data were obtained retrospectively from medical records, device telemetry, and manufacturer reports. This registry is listed on ClinicalTrials.gov (NCT05713708). Of the 1112 S-ICD devices analysed, 547 (49.2%) were equipped with a potentially affected capacitor linked to PBD occurrence, currently under Food and Drug Administration advisory. The median follow-up time for all patients was 46 [inter-quartile range (IQR) 24-63] months. Clinically suspected PBD was observed in 159 (29.1%) of cases, with a median time to generator removal or replacement of 65 (IQR 55-72) months, indicative of significant deviations from expected battery lifespan. Manufacturer confirmation of PBD was made in 91.7% of devices returned for analysis. No cases of PBD were observed in devices that were not under advisory. CONCLUSION: This manufacturer-independent analysis highlights a notable incidence of PBD in patients equipped with S-ICD models under advisory, and the rate of PBD in this study corresponds to the rate currently estimated by the manufacturer. To the best of our knowledge, this provides the largest contemporary peer-reviewed study cohort investigating the actual incidence of PBD in S-ICD patients. These findings emphasize the importance of post-market registries in collaboration between clinicians and the manufacturer to optimize safety and efficacy in S-ICD treatment.

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The utilization of endostapler devices has become standard practice for renal vein ligation during laparoscopic nephroureterectomy. While exceptionally rare, malfunctions can occur in these devices. In the video, we present a malfunctioning endostapler that became trapped on the renal vein. Fortunately, this catastrophic event was successfully managed without conversion to open surgery or massive blood loss and was recorded on video. We propose a structured management flow chart for addressing GIA malfunction, aiming to assist surgeons in navigating through this potentially life-threatening situation.

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Intrauterine devices (IUDs) have become one of the most frequently used forms of long-acting reversible contraception (LARC) in women of childbearing age. While complications are generally considered to be minimal, they can occur during the insertion, during use, or upon removal. Uterine anomalies, such as a bicornuate uterus, can increase the risk of complications during all stages. Here, we describe a case of a patient with a bicornuate uterus who had a levonorgestrel IUD in place for five years before she experienced a dislodging of the IUD, fragmentation upon attempted removal, and ultimately required a hysteroscopy to remove an embedded fragment from the endocervical canal. Due to the limited reporting on fragmented IUDs, further studies will be required to assess the optimal management. While symptomatic patients should have the fragment removed, asymptomatic patients should have their individual history and desire for future pregnancy weighed against the risk and benefits of treatment.

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OBJECTIVE: Drug-resistant epilepsy (DRE) can have devastating consequences for patients and families. Vagal nerve stimulation (VNS) is used as a surgical adjunct for treating DRE not amenable to surgical resection. Although VNS is generally safe, it has its inherent complications. With the increasing number of implantations, adequate patient education with discussion of possible complications forms a critical aspect of informed consent and patient counseling. There is a lack of large-scale reviews of device malfunction, patient complaints, and surgically related complications available to date. MATERIALS AND METHODS: Complications associated with VNS implants performed between 2011 and 2021 were identified through a search of the United States Food and Drug Administration Manufacturer And User Facility Device Experience (MAUDE) data base. We found three models on the data base, CYBERONICS, INC pulse gen Demipulse 103, AspireSR 106, and SenTiva 1000. The reports were classified into three main groups, "Device malfunction," "Patient complaints," and "Surgically managed complications." RESULTS: A total of 5888 complications were reported over the ten-year period, of which 501 reports were inconclusive, 610 were unrelated, and 449 were deaths. In summary, there were 2272 reports for VNS 103, 1526 reports for VNS 106, and 530 reports for VNS 1000. Within VNS 103, 33% of reports were related to device malfunction, 33% to patient complaints, and 34% to surgically managed complications. For VNS 106, 35% were related to device malfunction, 24% to patient complaints, and 41% to surgically managed complications. Lastly, for VNS 1000, 8% were device malfunction, 45% patient complaints, and 47% surgically managed complications. CONCLUSION: We present an analysis of the MAUDE data base for adverse events and complications related to VNS. It is hoped that this description of complications and literature review will help promote further improvement in its safety profile, patient education, and management of both patient and clinician expectations.

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Bioabsorbable implants (eg, Latera) have recently been approved for addressing nasal valve collapse. The purpose of this study is to summarize adverse events and treatment sequelae associated with bioabsorbable nasal implants queried in the Manufacturer and User Facility Device Experience (MAUDE) database. Of the 26 device reports entered between March 2017 and April 2022, the most frequently reported complications included abscess (n = 13) and implant protrusion (n = 5). Other common symptoms reported greater than 1-year postimplantation included facial pain/discomfort (n = 3) and failure to absorb (n = 3). Management of adverse events included treatment with antibiotics (n = 9), steroid injections (n = 4), and explantation (n = 20). In 3 reports, adverse reactions required a biopsy of adjacent tissue for pathologic analysis. These findings suggest that further research is required to assess the potential long-term complications and optimize the management of bioabsorbable nasal implants. Furthermore, standardized reporting templates may improve the utility of the MAUDE database.

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OBJECTIVE: Evaluate rates of Advanced Bionics Ultra 3D/Ultra cochlear implant failure in the setting of a worldwide device recall and report surgical and auditory outcomes after revision. METHODS: Retrospective chart review was performed for adult and pediatric patients implanted with at risk devices at our center from 2016 to 2020. Device failure rates, surgical, and auditory outcomes were recorded and analyzed. RESULTS: Of 113 at-risk devices, 20 devices (17.7%) in 18 patients (two bilaterally implanted) were identified as failures. All devices were with mid-scala electrodes. Eleven patients (61.1%) were children and 7 (38.9%) adults. Twelve patients were found to have failing devices after reporting subjective performance decline; the remainder were prompted by manufacturer notification. All were revised, with the majority (83.3%) choosing the same manufacturer. All had uncomplicated original and revision insertions. Among adults, average word scores on the revised side were stable pre- to post-revision (P = 0.95). DISCUSSION: Patients with device failure due to this field action performed well after revision implantation. Patients with bilateral at-risk devices but evidence of unilateral failure may elect to undergo simultaneous empiric revision of the contralateral device. Three patients who elected to change device manufacturers on revision have variable results that require further investigation. CONCLUSIONS: Patients requiring revision for a device field action overall perform well. At-risk devices continue to require monitoring as a growing number are likely to fail over time.

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INTRODUCTION: Flexible cystoscopes can be multi-use devices that visually inspect genitourinary structures such as the bladder and urethra. The objective of this study is to characterize the adverse events and associated device malfunctions of reusable flexible cystoscopes and to provide information on contamination and post-procedural infections. MATERIALS AND METHODS: The Manufacturer and User Facility Device Experience (MAUDE) database was queried for all adverse events and device malfunctions related to the use of flexible cystoscopes between January 2015 and December 2020. The MAUDE adverse event classification system was used to standardize the severity of complications and special focus was taken to identify clusters of events related to a single device. RESULTS: A total of 335 adverse events related to flexible cystoscopes were identified. Most adverse events associated with patient harm were caused by infection (n = 121), which included 19 cases of sepsis, one ICU admission, and one death. Among the infections, 29 cases showed growth of the same organism in both the device and patient. There were five infectious outbreaks identified and each outbreak was attributed to a single cystoscope. Other adverse events included mechanical malfunction (n = 6) and allergic reaction (n = 1). CONCLUSIONS: Our findings highlight the risk of post-procedural infection associated with flexible cystoscope contamination. Further studies are needed to characterize the prevalence and incidence of flexible cystoscope contamination and to develop strategies to prevent post-procedural infection.

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Despite the widespread use of peripheral intravenous catheters, unscheduled catheter failure before completion of treatment occurs frequently. If a large vein is selected, catheter failures may be prevented despite administering a highly irritant drug. In this study, we attempted to use a catheter that can be placed in a large upper arm vein. The new catheter was 88 mm long but had no guidewire to reduce contamination risk. This study aimed to evaluate the safety of the first-in-human trial for the new catheter with the administration of highly irritant drugs. This study was conducted at a university hospital in Tokyo, Japan. Eight Japanese adults were hospitalized adults with planned administration of non-cancer drugs with high irritant potential using a peripheral catheter. A trained nurse catheterized with the new catheter in the upper arm using ultrasonography. The catheterization site was monitored by staff and a research nurse once every 24 hours for up to 7 days. No adverse events or catheter failure occurred and the catheter placement success rate was 100%. In two patients, a temporary occlusion alarm of the infusion pump occurred, possibly due to the flexion of the catheter base. The new peripheral intravenous catheter did not interrupt medical treatments as is common after placement, but safety administered the irritant drugs. However, because this catheter may be easily affected by the contraction of the muscle at the fixation position, the position and method of catheter fixation in the upper arm need to be carefully considered.

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The HeartWare HVAD System (Medtronic) is a durable implantable left ventricular assist device that has been implanted in approximately 20,000 patients worldwide for bridge to transplant and destination therapy indications. In December 2020, Medtronic issued an Urgent Medical Device Communication informing clinicians of a critical device malfunction in which the HVAD may experience a delay or failure to restart after elective or accidental discontinuation of pump operation. Moreover, evolving retrospective comparative effectiveness studies of patients supported with the HVAD demonstrated a significantly higher risk of stroke and all-cause mortality when compared with a newer generation of a commercially available durable left ventricular assist device. Considering the totality of this new information on HVAD performance and the availability of an alternate commercially available device, Medtronic halted the sale and distribution of the HVAD System in June 2021. The decision to remove the HVAD from commercial distribution now requires the use of the HeartMate 3 left ventricular assist system (Abbott, Inc) if a patient previously implanted with an HVAD requires a pump exchange. The goal of this document is to review important differences in the design of the HVAD and HeartMate 3 that are relevant to the medical management of patients supported with these devices, and to assess the technical aspects of an HVAD-to-HeartMate 3 exchange. This document provides the best available evidence that supports best practices. (J Thorac Cardiovasc Surg 2022;-:1-8).

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The HeartWare HVAD System (Medtronic) is a durable implantable left ventricular assist device that has been implanted in approximately 20,000 patients worldwide for bridge to transplant and destination therapy indications. In December 2020, Medtronic issued an Urgent Medical Device Communication informing clinicians of a critical device malfunction in which the HVAD may experience a delay or failure to restart after elective or accidental discontinuation of pump operation. Moreover, evolving retrospective comparative effectiveness studies of patients supported with the HVAD demonstrated a significantly higher risk of stroke and all-cause mortality when compared with a newer generation of a commercially available durable left ventricular assist device. Considering the totality of this new information on HVAD performance and the availability of an alternate commercially available device, Medtronic halted the sale and distribution of the HVAD System in June 2021. The decision to remove the HVAD from commercial distribution now requires the use of the HeartMate 3 left ventricular assist system (Abbott, Inc) if a patient previously implanted with an HVAD requires a pump exchange. The goal of this document is to review important differences in the design of the HVAD and HeartMate 3 that are relevant to the medical management of patients supported with these devices, and to assess the technical aspects of an HVAD-to-HeartMate 3 exchange. This document provides the best available evidence that supports best practices.

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Reservoir induced bladder rupture is a rare complication of inflatable penile prosthesis (IPP) revision surgery. Our aim is to review the literature and describe our experience with this complication using two case reports that involved reusing an in-situ reservoir. In each case, an episode of gross hematuria indicated that a bladder rupture had occurred. From our experience, we propose ways to possibly avoid and if necessary, manage this rare complication.

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Left ventricular assist devices (LVADs) improve symptoms and outcomes in advanced heart failure. Although device malfunction has decreased significantly with later generation LVADs, it has not been eliminated. We describe the clinical course of a patient with HeartMate 3 LVAD who experienced device malfunction, involving temporary pump shutdown suspected to be caused by electrostatic discharge. (Level of Difficulty: Advanced.).

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BACKGROUND AND PURPOSE: The prevalence of patients with a cardiac implantable device (CIED) developing cancer and requiring a course of radiotherapy (RT) is increasing remarkably. Previously published reports agree that standard and conventionally fractionated RT is usually safe for CIEDs, but no "in-vivo" reports are available on the potential effects of thoracic stereotactic ablative radiotherapy (SABR) regimens to CIEDs functioning. The purpose of our study is therefore to evaluate the effects of SABR on CIEDs (pacemakers [PM] or implantable cardiac defibrillators [ICD]) in a cohort of patients affected by primary or metastatic lung lesions. MATERIALS AND METHODS: We retrospectively collected all CIED-bearing patients undergoing SABR between 2007 and 2019 at our Institution. All CIEDs were interrogated before and after the SABR course to check for any malfunction. Prescription dose, beam energy and maximum dose (Dmax) to CIEDs were retrieved for each patient. Electrical records of the CIEDs were reviewed by the medical records. RESULTS: Thirty-four consecutive patients (24 with a PM and 10 with an ICD), who underwent 38 separate SABR courses, were included in the study. Eight patients (24%) were PM-dependent. Prescription dose of SABR ranged 26-60 Gy in 1-8 fractions, with a photon energy ranging 6-to-10 MV (76.3% and 23.7%, respectively) and a median Dmax to CIEDs of 0.17 Gy (range 0.04-1.97 Gy). Electrical parameters were stable in post-treatment device programming visits and no transient or persistent alteration of the CIED function was recorded in any patient. No inappropriate interventions were recorded in the 10 ICD-bearing patients during the treatment fractions. CONCLUSIONS: Thoracic SABR proved to be safe for CIEDs when the dose is kept <2 Gy and the beam energy is ≤10 MV, irrespective of the pacing-dependency and of the CIED type.

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Robotic prostatectomy is the most commonly performed robotic procedure in the United States. Increasing utilization of this procedure necessitates characterization of robot malfunctions and associated patient injuries. We performed a review of adverse events reported to a publicly available database. We searched the Manufacturer and User Facility Device Experience (MAUDE) database for reported adverse events (RAE) involving the intuitive surgical system. Reports involving prostatectomy from 2014 to 2019 were extracted and analyzed for data regarding death, patient injury, and device malfunction. Of 9109 reported adverse events (RAE), 602 were extracted for robotic prostatectomy over the study period. Seven were patient deaths (1.2%), 53 (8.8%) were patient injuries (Table 1), and 542 (90.0%) were malfunctions (Table 2). Malfunctions resulted in 25 aborted cases, 21 open conversions, and 25 laparoscopic conversions (71/542, 13.1%; Fig. 1). Instrument failures comprised the majority (76.4%) of malfunctions. Seven malfunctions (1.3%) resulted in patient injury. The most common device-related injury involved the monopolar curved scissors. No reported deaths were related to robot malfunction. Instrument failures comprise majority of the malfunctions of the Da Vinci robot during robot-assisted laparoscopic prostatectomy. When malfunctions do occur they are usually recoverable and rarely lead to patient injury.

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With mounting time on continuous-flow left ventricular assist device (CF-LVAD) support, patients occasionally sustain damage to the device driveline. Outcomes associated with external and internal driveline damage and repair are currently not well documented. We sought to evaluate the outcomes of driveline damage and its repair. Electronic search was performed to identify all relevant studies published over the past 20 years. Fifteen studies were selected for analysis comprising of 55 patients with CF-LVAD dysfunction due to driveline damage. Demographic and perioperative variables along with outcomes including survival rates were extracted and pooled for the systematic review. Most patients (53/55) were supported on HeartMate II LVAD (Abbott Laboratories, Abbott Park, IL). Internal damage was more commonly reported than external damage [69.1% (38/55) vs. 30.9% (17/55), P = .01]. Median time to driveline damage was 1.9 years [IQR 1.0, 2.5]. Most patients presented with a CF-LVAD alarm [94.5% (52/55)] and patients with internal driveline damage had a significantly higher rate of alarm activation compared to that observed for those with external damage [38/38 (100%) vs. 14/17 (82.4%), P = .04]. Patients with internal driveline dysfunction were more likely to experience component wear compared to those with external driveline dysfunction [10/38 (26.3%) vs. 0/17 (0%), P = .05]; 14.5% of patients (8/55) underwent external repair of the driveline, 5.5% (3/55) were treated with rescue tape, and 5.5% (3/55) were placed on an ungrounded cable, indicating a short-to-shield event had occurred. A total of 49.1% of patients (27/55) underwent CF-LVAD exchange, 5.5% (3/55) were weaned off the CF-LVAD to explant, and 5.5% (3/55) underwent emergent heart transplantation. The median length of hospital stay was 12 days [IQR 7, 12] and 30-day mortality rate was 14.5% (8/55). Driveline damage was more commonly reported at an internal location and despite being a well-recognized complication, mortality still appears high.

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The analysis of the pacemaker ECG is usually regarded as difficult and may generate rather mediocre interpretations. It is a common opinion that a pacemaker ECG can only be analyzed if the type of pacemaker (single-, dual-, triple-chamber, manufacturer, model) and its programming are known. The following pitfalls illustrate how to achieve a clinically meaningful ECG interpretation in daily practice, even if these details are not known. A systematic approach to ECG interpretation is particularly crucial in this context: Basic rhythm (P waves, intrinsic or paced rhythm), paced QRS complex (axis, width, bundle branch block morphology), signs of pacemaker malfunction (under­/oversensing, loss of capture), arrhythmia to which the pacemaker reacts, or activity of any pacemaker algorithm. Many small details should not be overlooked and many questions can be answered if a few principles are applied. Understanding of the pacemaker ECG can improve the life of a device patient at the touch of a button.

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BACKGROUND: Obesity remains a relative contraindication for heart transplantation, and hence, obese patients with advanced heart failure receive ventricular assist devices (VADs) either as a destination or "bridge to weight loss" strategy. However, impact of obesity on clinical outcomes after VAD implantation is largely unknown. We sought to determine the clinical outcomes of obese patients with body mass index (BMI) ≥ 35 kg/m2) following contemporary VAD implantation. METHODS: The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) registry was queried for patients who underwent VAD implantation. Patients were categorized into BMI groups based on World Health Organization classification. RESULTS: Of 17,095 patients, 2620 (15%) had a BMI ≥ 35 kg/m2. Obese patients were likely to be young, non-white, females with dilated cardiomyopathy and undergo device implantation as destination. Survival was similar amongst BMI groups (P = .058). Obese patients had significantly higher risk for infection (hazard ratio [HR]: 1.215; P = .001), device malfunction or thrombosis (HR: 1.323; P ≤ .001), cardiac arrhythmia (HR: 1.188; P = .001) and hospital readmissions (HR: 1.073; P = .022), but lower risk of bleeding (HR: 0.906; P = .018). Significant weight loss (≥10%) during VAD support was achieved only by a small proportion (18.6%) of patients with BMI ≥ 35 kg/m2. Significant weight loss rates observed in obese patients with VAD implantation as destination and bridge to transplant strategy were comparable. Obese patients with significant weight loss were more likely to undergo cardiac transplantation. Weight loss worsened bleeding risk without altering risk for infection, cardiac arrhythmia, and device complications. CONCLUSIONS: Obesity alone should not be considered a contraindication for VAD therapy in contemporary era. Given durability of heart transplantation, strategies should be developed to promote weight loss, which occurs infrequently in obese patients. Impact of weight loss on clinical outcome of obese patients warrants further investigation.

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