State of the Art Review of Surgical Techniques for Microaxial Flow Pump Implantation.

Recently, temporary mechanical circulatory support (tMCS) has been increasingly used for cardiogenic shock therapy. Originally designed as a bail-out option for patients who could not be weaned from cardiopulmonary bypass, the indications for tMCS have been expended and now enable us to support a wide range of patients with various cardiac pathologies. Modern tMCS devices include microaxial flow pumps (mAFP) which are small, versatile systems that can provide both acute cardiac support and cardiac protection for high-risk interventions. In this paper, we review different surgical implantation techniques with modern mAFP as well as specific aspects of preoperative indications and patient evaluation.

Patient related outcomes of mechanical lead extraction techniques (PROMET) study: A comparison of two professions.

BACKGROUND: With an increasing number of cardiac implantable electronic devices (CIEDs), there has been a paralleled increase in demand for transvenous lead extraction (TLE). Cardiac surgeons (CS) and cardiologists perform TLE; however, data comparing the two groups of operators is scarce. OBJECTIVE: We compared the outcomes of TLE performed by cardiologists and CS from six European lead extraction units. METHOD: Data was collected retrospectively of 2205 patients who had 3849 leads extracted (PROMET) between 2005 and 2018. Patient demographics and procedural outcomes were compared between the CS and cardiologist groups, using propensity score matching. A multivariate regression analysis was also performed for variables associated with 30-day mortality. RESULTS: CS performed the majority of extractions (59.8%), of leads with longer dwell times (90 [57-129 interquartile range (IQR)] vs. 62 [31-102 IQR] months, CS vs. cardiologists, p < .001) and with pre-dominantly non-infectious indications (57.4% vs. 50.2%, CS vs. cardiologists, p < .001). CS achieved a higher complete success per lead than the cardiologists (98.1% vs. 95.7%, respectively, p < .01), with a higher number of minor complications (5.51% vs. 2.1%, p < .01) and similar number of major complications (0.47% vs. 1.3%, p = .12). Thirty-day mortality was similarly low in the CS and cardiologist groups (1.76% vs. 0.94%, p = .21). Unmatched data multivariate analysis revealed infection indication (OR 6.12 [1.9-20.3], p < .01), procedure duration (OR 1.01 [1.01-1.02], p < .01) and CS operator (OR 2.67, [1.12-6.37], p = .027) were associated with 30-day mortality. CONCLUSION: TLE by CS was performed with similar safety and higher efficacy compared to cardiologists in high and medium-volume lead extraction centers.

Right atriotomy closure with modified ventricular assist device ring.

BACKGROUND: Severe tricuspid regurgitation is a known risk factor for right ventricular failure (RVF) after left ventricular assist device (LVAD) implantation and is often treated with concomitant tricuspid valve repair (TVR). The right atriotomy needed for exposure of the tricuspid valve may complicate early implantation of a durable right ventricular assist device, which may be needed if RVF persists. MATERIALS & METHODS: A 53-year-old male patient on Impella and extracorporeal life support was scheduled for LVAD implantation with concomitant TVR. RESULTS: We performed a technique for closure of the right atrium after TVR with a modified ventricular assist device ring to facilitate right ventricular support implantation if needed.

Transvenous lead extraction: The influence of age on patient outcomes in the PROMET study cohort.

BACKGROUND: Cardiac implantable electronic device (CIED) therapy contributes to an improvement in morbidity and mortality across all patient demographics. Patient age is a recognized risk factor for unfavorable outcomes in invasive procedures. This is the largest series of non-laser transvenous lead extraction (TLE) evaluating the association between patient age and procedure outcomes. METHODS: Data of 2205 (3849 leads) patients was collected retrospectively from six European TLE centers between January 2005-December 2018 in the PROMET study. Of these, 153 patients with 319 leads were excluded for incomplete data. A comparison of outcomes was performed between the age groups young [< 50 years], young intermediate [50-69 years], older intermediate [70-79 years], and octogenarian [≥80 years]. RESULTS: Infection was most common indication for TLE in the octogenarian cohort, less common in the younger population (60.1% vs. 33.2%, respectively, p < .01). High-voltage leads were extracted most frequently from young patients, less frequently from octogenarians (31.6% vs. 10%, p < .001), while the opposite was evident for pacemaker leads (p < .001). Rotational sheath use was equally prevalent across all patient groups (p = .79). Minor and major complications across all the age groups were statistically similar, as was procedural success; the 30-day mortality was most significant in the octogenarian and least in the young patients (4.9% vs. 0.4%, p = .005). Propensity matching multivariate analysis found systemic infection, lead dwell time, and patient age (p = .013, OR 1.064 [1.013-1.116]) increased risk of 30-day mortality. CONCLUSION: TLE is safe and effective across all age groups. 30-day mortality risk is significantly higher in the older patients.

Results of the Patient-Related Outcomes of Mechanical lead Extraction Techniques (PROMET) study: a multicentre retrospective study on advanced mechanical lead extraction techniques.

AIMS: Several large studies have documented the outcome of transvenous lead extraction (TLE), focusing on laser and mechanical methods. To date there has been no large series addressing the results obtained with rotational lead extraction tools. This retrospective multicentre study was designed to investigate the outcomes of mechanical and rotational techniques. METHODS AND RESULTS: Data were collected on a total of 2205 patients (age 66.0 ± 15.7 years) with 3849 leads targeted for extraction in six European lead extraction centres. The commonest indication was infection (46%). The targeted leads included 2879 pacemaker leads (74.8%), 949 implantable cardioverter-defibrillator leads (24.6%), and 21 leads for which details were unknown; 46.6% of leads were passive fixation leads. The median lead dwell time was 74 months [interquartile range (IQR) 41-112]. Clinical success was obtained in 97.0% of procedures, and complete extraction was achieved for 96.5% of leads. Major complications occurred in 22/2205 procedures (1%), with a peri-operative or procedure-related mortality rate of 4/2205 (0.18%). Minor complications occurred in 3.1% of procedures. A total of 1552 leads (in 992 patients) with a median dwell time of 106 months (IQR 66-145) were extracted using the Evolution rotational TLE tool. In this subgroup, complete success was obtained for 95.2% of leads with a procedural mortality rate of 0.4%. CONCLUSION: Patient outcomes in the PROMET study compare favourably with other large TLE trials, underlining the capability of rotational TLE tools and techniques to match laser methods in efficacy and surpass them in safety.

Physical preconditioning on biventricular temporary mechanical circulatory support while awaiting heart transplantation.

Temporary mechanical circulatory support (tMCS) is increasingly used in patients with cardiogenic shock as a bridge to further treatment. We present the case of a 52-year-old female patient with biventricular heart failure who was bridged to heart transplantation employing biventricular tMCS through a non-femoral access. The 'groin-free' tMCS concept facilitates pre-habilitation while awaiting heart transplantation.

Transcatheter management of pure native aortic valve regurgitation in patients with left ventricular assist device.

OBJECTIVES: Aortic valve regurgitation (AR) frequently complicates the clinical course after left ventricular assist device (LVAD) implantation. Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement (SAVR) in this cohort with a mostly high surgical risk profile. The unique challenges in LVAD patients, such as presence of non-calcified aortic valves and annular dilatation, raise concerns about device migration and paravalvular leakage (PVL) leading to missing device success. This study evaluates procedural outcomes and survival rates in LVAD patients who underwent TAVI, emphasizing strategies to enhance device success. METHODS: Between January 2017 and April 2023, 27 LVAD patients with clinically significant AR underwent elective or urgent TAVI at our centre. Primary end-points were procedural success rates, without the need for a second transcatheter heart valve (THV) and postprocedural AR/PVL. Secondary outcomes included survival rates and adverse events. RESULTS: Among the cohort, 14.8% received AR-dedicated TAVI devices, with none requiring a second THV. There was no intraprocedural AR, and 1 patient (25%) had AR > 'trace' at discharge. Additionally, 25.9% underwent device landing zone (DLZ) pre-stenting with a standard TAVI device, all without needing a second THV. There was no intraprocedural AR, and none to trace AR at discharge. Among the 59.3% receiving standard TAVI devices, 37.5% required a second THV. In this subgroup, intraprocedural AR > 'trace' occurred in 12.5%, decreasing to 6.25% at discharge. In-hospital mortality was 3.7%, and median follow-up survival was 388 days (interquartile range 208-1167 days). CONCLUSIONS: TAVI yields promising procedural outcomes and early survival rates in LVAD patients with AR. Tailored TAVI devices and pre-stenting techniques enhance procedural success. Continued research into these strategies is essential to optimize outcomes in this complex patient cohort.

Deactivation of LVAD support for myocardial recovery-surgical perspectives.

Left ventricular assist devices (LVADs) are excellent therapies for advanced heart failure patients either bridged to transplant or for lifetime use. LVADs also allow for reverse remodeling of the failing heart that is often associated with functional improvement. Indeed, growing enthusiasm exists to better understand this population of patients, whereby the LVAD is used as an adjunct to mediate myocardial recovery. When patients achieve benchmarks suggesting that they no longer need LVAD support, questions related to the discontinuation of LVAD therapy become front and center. The purpose of this review is to provide a surgical perspective on the practical and technical issues surrounding LVAD deactivation.

Removal of Wall-Adherent Inferior Vena Cava Thrombus with a Combined Approach Using Vacuum-Assisted Thrombectomy and a Rotational Thrombectomy Device.

Introduction. Large thrombi in the inferior vena cava pose a high risk for a pulmonary embolism. Percutaneous extracorporeal circulation-based vacuum-assisted thrombus aspiration is a viable option for removal. Wall adherence of thrombotic material can compromise procedural success. Case Report. A 46-year-old female presented with a subtotal thrombotic occlusion of the inferior vena cava and the proximal right common iliac vein after weaning from extracorporeal life support. Due to severe wall adherence of the thrombotic material, the patient was treated with the combination of percutaneous extracorporeal circulation-based thrombus aspiration using the AngioVac system and a rotational thrombectomy device.

Severe pulmonary valve insufficiency caused by transjugular cannulation of pulmonary artery for right ventricular assist device: diagnosis and surgical solution-a case report.

Implantation of a temporary percutaneous right ventricular assist device (RVAD) in patients with right heart failure after left ventricular assist device (LVAD) implantation is an established technique that may cause complications. We present a 60-year-old male patient who underwent urgent LVAD implantation. On the second postoperative day the patient developed acute right heart failure. We implanted a temporary percutaneous RVAD with two cannulas via the right internal jugular vein and the right femoral vein. Transesophageal echocardiography revealed severe pulmonary insufficiency. After performing re-sternotomy we anastomosed a prosthetic graft to the pulmonary trunk (PT), performed subxiphoid tunneling of the graft and replaced the transjugular outflow cannula. The pulmonary regurgitation caused by the percutaneous transvalvular cannula disappeared. In such case a direct anastomosis to the PT is the solution.

Complications related to the access site after transaxillary implantation of a microaxial left ventricular assist device.

BACKGROUND: Impella 5.0 and 5.5 (summarized as Impella 5+) are microaxial, catheter-based left ventricular assist devices (LVAD) that are implanted via a vascular graft sutured to the axillary artery and provide blood flow of up to 5.5 liter/min. This study aims to investigate the incidence of long-term complications following circulatory support with Impella 5+. METHODS: A single-center retrospective analysis of 203 consecutive adult patients treated between January 2017 and September 2021 with a surgically implanted Impella 5.0 or 5.5 via a vascular graft sutured to the axillary artery. RESULTS: The median Impella support duration was 8 days. Of 203 patients, 78 (38.4%) died while on temporary mechanical circulatory support. Fifty-five (27.1%) were successfully weaned from Impella 5+ and 70 (34.5%) were bridged to a durable LVAD with a median follow-up time of 232 (IQR 68.5, 597) days after Impella 5+ explantation. In 119 of these patients, the Impella was explanted and the vascular graft was shortened, ligated, and pushed under the pectoralis muscle; in 6 patients early graft infection prompted complete graft removal during explantation. In addition, 13 patients (10.9%) developed a late-onset graft infection after a median of 86 days, requiring complete (n = 10) or partial (n = 2) explantation of the retained graft. In 1 patient, the graft infection was successfully treated by conservative therapy. Our analysis identified no specific risk factors for graft infections. Of the 203 patients, 5 (2.5%) developed a brachial plexus injury resulting in neurological dysfunction. CONCLUSIONS: In 10.9% of patients, retaining the vascular graft was complicated by a late graft infection. Complete explantation of the graft prosthesis may decrease the infection rate, but may in turn increase the risk of brachial plexus injury. On the other hand, this method offers the possibility of bedside explantation.

Transvenous lead extraction in children with bidirectional rotational dissection sheaths.

Objectives: Due to the limited longevity of endovascular leads, children require thoughtful lifetime lead management strategies including conservation of access vessel patency. Consequently, there is an increasing interest in transvenous lead extraction (TLE) in children, however, data on TLE and the use of powered mechanical dissection sheaths is limited. Methods: We performed a retrospective cohort study analyzing all children <18 years that underwent TLE in our institution from 2015 to 2022. Procedural complexity, results and complications were defined as recommended by recent consensus statements. Results: Twenty-eight children [median age 12.8 (interquartile range 11.3-14.6) years] were included. Forty-one leads were extracted [median dwell time 85 (interquartile range 52-102) months]. Extractions of 31 leads (76%) in 22 patients (79%) were complex, requiring advanced extraction tools including powered bidirectional rotational dissection sheaths in 14 children. There were no major complications. Complete procedural success was achieved in 18 (64%) and clinical success in 27 patients (96%), respectively. Procedural success and complexity varied between lead types. The Medtronic SelectSecure™ lead was associated with increased odds of extraction by simple traction (p = 0.006) and complete procedural success (p < 0.001) while the Boston Scientific Fineline™ II lead family had increased odds of partial procedural failure (p = 0.017). Conclusions: TLE with the use of mechanical powered rotational dissection sheaths is feasible and safe in pediatric patients. In light of rare complications and excellent overall clinical success, TLE should be considered an important cornerstone in lifetime lead management in children. Particular lead types might be more challenging and less successful to extract.

Impella for the Management of Ventricular Septal Defect Complicating Acute Myocardial Infarction: A European Multicenter Registry.

Ventricular septal defect (VSD) is a rare but severe complication of myocardial infarction (MI). Temporary mechanical circulatory support (MCS) can be used as a bridge to VSD closure, heart transplantation, or ventricular assist device. We describe the use of Impella device in this context based on a multicenter European retrospective registry (17 centers responded). Twenty-eight post-MI VSD patients were included (Impella device were 2.5 for 1 patient, CP for 20, 5.0 for 5, and unknown for 2). All patients were in cardiogenic shock with multiple organ failure (SAPS II 41 [interquantile range {IQR} = 27-53], lactate 4.0 ± 3.5 mmol/L) and catecholamine support (dobutamine 55% and norepinephrine 96%). Additional temporary MCS was used in 14 patients (50%), mainly extracorporeal life support (ECLS) (n = 9, 32%). Severe bleedings were frequent (50%). In-hospital and 1 year mortalities were 75%. Ventricular septal defect management was surgical for 36% of patients, percutaneous for 21%, and conservative for 43%. Only surgically managed patients survived (70% in-hospital survival). Type and combination of temporary MCS used were not associated with mortality (Impella alone or in combination with intra-aortic balloon pump [IABP] or ECLS, p = 0.84). Impella use in patients with post-MI VSD is feasible but larger prospective registries are necessary to further elucidate potential benefits of left ventricular unloading in this setting.

Surgical Ventricular Reconstruction Eligible for Late Assist Device Implantation.

In patients with ischemic cardiomyopathy and left ventricular aneurysm formation who are symptomatic despite optimal medical therapy, it is challenging to determine whether surgical ventricular reconstruction, heart transplantation, or left ventricular assist device (LVAD) implantation is the treatment of choice. This report describes the concept of surgical ventricular reconstruction with a specially prepared LVAD fixation ring to facilitate subsequent LVAD implantation if required. In the patient reported in this case, endoventricular circular LVAD ring plasty sufficiently reduced the ventricular volume, normalized the left ventricular geometry, and subsequently led to an improvement of left ventricular ejection fraction.

The iTOP trial: Comparing immediate techniques of oncoplastic surgery with conventional breast surgery in women with breast cancer - A prospective, controlled, single-center study.

INTRODUCTION: Oncoplastic techniques allow resection of larger tumors, permitting breast conservation in cases otherwise requiring mastectomy. We sought to prospectively compare quality of life (QoL) in patients undergoing oncoplastic surgery as compared to conventional breast conservation (CBC) or mastectomy is lacking. METHODS: Patients diagnosed with BIRADS IV-VI lesion were eligible if resection of ≥10% of the breast volume was planned. Patients were allowed to decide whether they wanted to undergo CBC or oncoplastic breast conservation (OBC). Patients who underwent mastectomy and immediate breast reconstruction (IBR) were also included for comparison. The primary endpoint was breast self-esteem using the Breast Image Scale (BIS) at 12 months, secondary endpoints were perioperative morbidity and QoL using the BREAST-Q questionnaire. RESULTS: From 2011 to 2016, 205 patients were included in the study. 116 patients (56.6%) received CBC, 46 (22.4%) OBC and 43 (21%) MIBR. Women in the OBC group were more likely to have tumors ≥ 2 cm than those in the CBC group (34.7% vs. 17.5%, respectively). Women who underwent MIBR were more likely to have tumors > 5 cm than those in the CBC and OBC groups (23% vs 1% and 10%, respectively). The BIS and BREAST-Q improved in each group after 12 months but did not differ significantly between groups at any time point. Surgical complications (seroma, bleeding, infection, necrosis) were numerically more likely in the OBC and MIBR groups. CONCLUSION: OBC and the MIBR allow for resection of larger tumors with a similar quality of life as CBC.

Two implantable continuous-flow ventricular assist devices in a biventricular configuration: technique and results.

OBJECTIVES: No continuous-flow right ventricular assist device for long-term support is available at the moment. Two continuous-flow ventricular assist devices used in a continuous-flow biventricular assist device configuration is an emerging option which has proven its feasibility but still is not approved for routine use. We present our technique and results of modifying the left ventricular assist device and making it suitable for right ventricular support. METHODS: Between September 2009 and October 2017, 39 patients received implantation of a continuous-flow ventricular assist device for right ventricular support in a continuous-flow biventricular assist device configuration. For implantation of the HeartWare® manufacturers name of the pump HeartWare HVAD pump (HVAD)® centrifugal ventricular assist device, we performed 2 major modifications: banding of the outflow graft and reducing the intracaval length of the inflow cannula. The HVAD® could be safely implanted into the right atrium or ventricle. The HeartMate 3® left ventricular assist device needed no banding, but we increased the extraventricular part of the inflow cannula. RESULTS: The overall 30-day survival for the group receiving primarily a continuous-flow biventricular assist device was 72.7% (9.5% standard error of the mean (SEM)), and the 1-year survival was 45.0% (10.7% SEM). The overall 30-day survival for the group receiving a subsequent pump for right ventricular support in a continuous-flow biventricular assist device configuration after temporary right ventricular support was 71.4% (12.1% SEM), and 1-year survival was 40.8% (13.6% SEM). CONCLUSIONS: At the moment, there is a lack of a continuous-flow right ventricular assist device especially designed and approved for right ventricular support. Therefore, modifications in continuous-flow ventricular assist devices designed for the left ventricle are done to make them suitable for right ventricular support. However, more information is needed regarding the optimal surgical technique, patient selection and the optimal time point of implantation.