Treatment of cardiac implantable electronic device endocarditis in pacemaker-dependent patients utilizing a percutaneous aspiration system.

With the increasing use of cardiac implantable electronic devices, the number of patients with cardiac implantable electronic device-related endocarditis is also rising. The treatment of this type of endocarditis is a challenging clinical task, in particular if device removal is required in patients who are pacemaker dependent. This video tutorial describes a treatment strategy for cardiac implantable electronic device-related endocarditis involving the tricuspid valve in pacemaker-dependent patients. The proposed treatment strategy consists of implanting an epicardial pacemaker via a minimally invasive subxiphoid approach, percutaneous aspiration of tricuspid valve vegetations and complete transvenous explantation of the infected cardiac implantable electronic device system using advanced lead extraction tools.

Mechanical Circulatory Support Strategies in Takotsubo Syndrome with Cardiogenic Shock: A Systematic Review.

BACKGROUND: Takotsubo syndrome is, by definition, a reversible form of acute heart failure. If cardiac output is severely reduced, Takotsubo syndrome can cause cardiogenic shock, and mechanical circulatory support can serve as a bridge to recovery. To date, there are no recommendations on when to use mechanical circulatory support and on which device is particularly effective in this context. Our aim was to determine the best treatment strategy. METHODS: A systematic literature research and analysis of individual patient data was performed in MEDLINE/PubMed according to PRISMA guidelines. Our research considered original works published until 31 July 2023. RESULTS: A total of 93 publications that met the inclusion criteria were identified, providing individual data from 124 patients. Of these, 62 (50%) were treated with veno-arterial extracorporeal life support (va-ECLS), and 44 (35.5%) received a microaxial left ventricular assist device (Impella). Eighteen patients received an Impella CP and twenty-one an Impella 2.5. An intra-aortic balloon pump (IABP) without other devices was used in only 13 patients (10.5%), while other devices (BiVAD or Tandem Heart) were used in 5 patients (4%). The median initial left ventricular ejection fraction was 20%, with no difference between the four device groups except for the IABP group, which was less affected by cardiac output failure (p = 0.015). The overall survival was 86.3%. Compared to the other groups, the time to cardiac recovery was shorter with Impella (p < 0.001). CONCLUSIONS: Though the Impella treatment is new, our analysis may show a significant benefit of Impella compared to other MCS strategies for cardiogenic shock in Takotsubo syndrome.

Transvenous lead extraction: Experience of the Tandem approach.

AIMS: Transvenous lead extraction (TLE) is important in the management of cardiac implantable electronic devices but carries risk. It is most commonly completed from the superior access, often with 'bail-out' support via the femoral approach. Superior and inferior access may be used in tandem, which has been proposed as an advance in safety and efficacy. The aim of this study is to evaluate the safety and efficacy of the Tandem approach. METHOD: The 'Tandem' procedure entailed grasping of the targeted lead in the right atrium to provide countertraction as a rotational dissecting sheath was advanced over the lead from the subclavian access. Consecutive 'Tandem' procedures performed by a single operator between December 2020 and March 2023 in a single large-volume TLE centre were included and compared with the conventional superior approach (control) using 1:1 propensity score matching; patients were statistically matched for demographics. RESULTS: The Tandem in comparison with the conventional approach extracted leads of much greater dwell time (148.9 ± 79 vs. 108.6 ± 77 months, P < 0.01) in a shorter procedure duration (96 ± 36 vs. 127 ± 67 min, P < 0.01) but requiring more fluoroscopy (16.4 ± 10.9 vs. 10.8 ± 14.9 min, P < 0.01). The Tandem and control groups had similar clinical (100% vs. 94.7%, P = 0.07) and complete (94.8% vs. 92.8%, P = 0.42) success, with comparable minor (4% vs. 6.7%, P = 0.72) and major (0% vs. 4%, P = 0.25) complications; procedural (0% vs. 1.3%, P = 1) and 30-day (1.3% vs. 4%, P = 0.62) mortality were also similar. CONCLUSION: The Tandem procedure is as safe and effective as the conventional TLE. It can be applied to leads of a long dwell time with a potentially shorter procedure duration.

Successful treatment of cardiogenic shock due to Takotsubo syndrome with implantation of a temporary microaxial left ventricular assist device in transaxillary approach.

OBJECTIVES: Cardiogenic shock (CS) can occur in patients with Takotsubo syndrome (TTS). As TTS has received increasing attention and has been more closely researched, several aspects of the pathogenesis have been identified, particularly that an excessive release of catecholamines plays an important role. Nevertheless, evidence on specific therapy concepts is still lacking. As a result, TTS with severe hemodynamic instability and low cardiac output creates unique challenges, and mechanical circulatory support is needed with as few inotropic drugs as possible. METHODS: We present a 77-year-old female patient who underwent minimally invasive surgical mitral valve replacement. After an uneventful course, the patient developed acute heart failure eleven days after surgery. Transthoracic echocardiography (TTE) revealed a new onset of TTS. The patient needed left ventricular venting and full haemodynamic flow. We successfully implanted a microaxial left ventricular assist device (Impella 5.5) using the transaxillary approach. The haemodynamic situation stabilised immediately. The patient was weaned and the Impella 5.5 was explanted after five days. CONCLUSION: We present the first-in-man implantation of a transaxillary Impella 5.5 in a patient with TTS. The patient benefitted from Impella 5.5 therapy with full haemodynamic support and venting of the left ventricle.

Comparison of non-laser and laser transvenous lead extraction: a systematic review and meta-analysis.

AIMS: Transvenous lead extraction (TLE) is performed using non-laser and laser techniques with overall high efficacy and safety. Variation in outcomes between the two approaches does exist with limited comparative evidence in the literature. We sought to compare non-laser and laser TLE in a meta-analysis. METHODS AND RESULTS: We searched Medline, Embase, Scopus, ClinicalTrials.gov, and CENTRAL databases for TLE studies published between 1991 and 2021. From the included 68 studies, safety and efficacy data were carefully evaluated and extracted. Aggregated cases of outcomes were used to calculate odds ratio (OR), and pooled rates were synthesized from eligible studies to compare non-laser and laser techniques. Subgroup comparison of rotational tool and laser extraction was also performed. Non-laser in comparison with laser had lower procedural mortality (pooled rate 0% vs. 0.1%, P < 0.01), major complications (pooled rate 0.7% vs. 1.7%, P < 0.01), and superior vena cava (SVC) injury (pooled rate 0% vs. 0.5%, P < 0.001), with higher complete success (pooled rate 96.5% vs. 93.8%, P < 0.01). Non-laser comparatively to laser was more likely to achieve clinical [OR 2.16 (1.77-2.63), P < 0.01] and complete [OR 1.87 (1.69-2.08), P < 0.01] success, with a lower procedural mortality risk [OR 1.6 (1.02-2.5), P < 0.05]. In the subgroup analysis, rotational tool compared with laser achieved greater complete success (pooled rate 97.4% vs. 95%, P < 0.01) with lower SVC injury (pooled rate 0% vs. 0.7%, P < 0.01). CONCLUSION: Non-laser TLE is associated with a better safety and efficacy profile when compared with laser methods. There is a greater risk of SVC injury associated with laser sheath extraction.

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.

Improving Survival in Cardiogenic Shock-A Propensity Score-Matched Analysis of the Impact of an Institutional Allocation Protocol to Short-Term Mechanical Circulatory Support.

Temporary mechanical circulatory support (tMCS) is a life-saving treatment option for patients in cardiogenic shock (CS), but many aspects such as patient selection, initiation threshold and optimal modality selection remain unclear. This study describes a standard operating procedure (SOP) for tMCS allocation for CS patients and presents outcome data before and after implementation. Data from 421 patients treated for CS with tMCS between 2018 and 2021 were analyzed. In 2019, we implemented a new SOP for allocating CS patients to tMCS modalities. The association between the time of SOP implementation and the 30-day and 1-year survival as well as hospital discharge was evaluated. Of the 421 patients included, 189 were treated before (pre-SOP group) and 232 after implementation of the new SOP (SOP group). Causes of CS included acute myocardial infarction (n = 80, 19.0%), acute-on-chronic heart failure in patients with dilated or chronic ischemic heart failure (n = 139, 33.0%), valvular cardiomyopathy (n = 14, 3.3%) and myocarditis (n = 5, 1.2%); 102 patients suffered from postcardiotomy CS (24.2%). The SOP group was further divided into an SOP-adherent (SOP-A) and a non-SOP-adherent group (SOP-NA). The hospital discharge rate was higher in the SOP group (41.7% vs. 29.7%), and treating patients according to the SOP was associated with an improved 30-day survival (56.9% vs. 38.9%, OR 2.21, 95% CI 1.01-4.80, p = 0.044). Patient allocation according to the presented SOP significantly improved 30-day survival.

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.

ILEEM-survey on the Heart Team approach and team training for lead extraction procedures.

BACKGROUND: The Heart Team approach has become an integral part of modern cardiovascular medicine. To evaluate current opinions and real-world practice among lead extraction practitioners, an online survey was created and distributed among a pool of lead extraction specialists participating in the International Lead Extraction Expert Meeting (ILEEM) 2018. METHODS: The online survey consisted of 10 questions and was performed using an online survey tool (www.surveymonkey.com). The collector link was sent to 48 lead extraction experts via email. RESULTS: A total of 43 answers were collected (89% return rate) from lead extraction experts in 16 different countries. A great majority (83.7%) of the respondents performed more than 30 lead extraction procedures per year. The most common procedural environment in this survey was the hybrid operating room (67.4%). Most procedures were performed by electrophysiologists and cardiologists (80.9%). Important additional members of the current lead extraction teams were cardiac surgeons (79.1%), anesthesiologists (95.3%) and operating room scrub nurses (76.7%). An extended Heart Team is regarded beneficial for patient care by 86.0%, with potential further members being infectious diseases specialists, intensivists and radiologists. Team training activities are performed in 48.8% of participating centers. CONCLUSIONS: This survey supports the importance of establishing lead extraction Heart Teams in specialized lead extraction centers to potentially improve patient outcomes. The concept of a core and an extended Heart Team approach in lead extraction procedures is introduced.

Persistent left superior vena cava transvenous lead extraction: A European experience.

BACKGROUND: Transvenous lead extraction (TLE) is rising in parallel to cardiac implantable electronic device implantations. Persistent left side superior vena cava (PLSVC) is a relatively common anatomical variant in the healthy population; TLE in patients with a PLSVC is rare. METHOD: Data were collated from 6 European TLE institutes of 10 patients who had undergone lead extraction with a PLSVC. Patient demographics, procedural challenges and outcomes were reported. RESULTS: Ten patients aged 73.4 ± 7.8 years (60% male) underwent TLE of 20 leads (3 left ventricle, 10 right ventricle, 7 right atrium) with dwell time of 82.95 ± 39.1 months. Of the 10 cases, 4 had an infection indication and 5 were biventricular system extractions; 25% of the extracted leads were defibrillator leads. The majority of the procedures were completed in the cardiac catheterization suite (80%) under general anaesthesia (60%) by cardiologists (80%) using a rotational powered sheath (65%). The Tandem approach was used successfully in 3 cases. Complete procedural success was obtained in 100% of cases in the absence of complications within 127.4 ± 74.7 min. There was no 30-day mortality. CONCLUSION: TLE in PLSVC is feasible albeit rare. Standard extraction techniques in experienced hands are associated with favorable outcomes; the Tandem procedure may be an additional technique to improve the safety and efficacy of TLE in PLSVC.

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.

Performance and outcomes of transvenous rotational lead extraction: Results from a prospective, monitored, international clinical study.

BACKGROUND: Transvenous lead extraction (TLE) plays a critical role in managing patients with cardiovascular implantable electronic devices. Mechanical TLE tools, including rotational sheaths, are used to overcome fibrosis and calcification surrounding leads. Prospective clinical data are limited regarding the safety and effectiveness of use of mechanical TLE devices, especially rotational tools. OBJECTIVE: To prospectively investigate the safety and effectiveness of mechanical TLE in real-world usage. METHODS: Patients were enrolled at 10 sites in the United States and Europe to evaluate the use of mechanical TLE devices. Clinical success, complete procedural success, and complications were evaluated through follow-up (median, 29 days). Patient data were source verified and complications were adjudicated by an independent clinical events committee (CEC). RESULTS: Between October 2018 and January 2020, mechanical TLE tools, including rotational sheaths, were used to extract 460 leads with a median indwell time of 7.4 years from 230 patients (mean age 64.3 ± 14.4 years). Noninfectious indications for TLE were more common than infectious indications (61.5% vs 38.5%, respectively). The extracted leads included 305 pacemaker leads (66.3%) and 155 implantable cardioverter-defibrillator leads (33.7%), including 85 leads with passive fixation (18.5%). A bidirectional rotational sheath was needed for 368 leads (88.0%). Clinical success was obtained in 98.7% of procedures; complete procedural success was achieved for 96.3% of leads. CEC-adjudicated device-related major complications occurred in 6 of 230 (2.6%) procedures. No isolated superior vena cava injury or procedural death occurred. CONCLUSION: This prospective clinical study demonstrates that use of mechanical TLE tools, especially bidirectional rotational sheaths, are effective and safe.

Surgical Implantation Techniques of Modern Continuous Flow Ventricular Assist Devices.

Implantable left ventricular assist devices (durable LVADs) have dramatically improved mortality and morbidity in patients with advanced heart failure. Originally designed as a bridge or candidacy to heart transplantation, the indications extend toward permanent support and palliation. Modern durable continuous flow LVADs are small, commercially available, and allow for different surgical approaches to a wide range of patients with various cardiac pathologies. We will review different surgical implantation techniques of modern continuous flow LVADs, as well as specific aspects of preoperative patient evaluation and planning.

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.

Transcatheter aspiration of large pacemaker and implantable cardioverter-defibrillator lead vegetations facilitating safe transvenous lead extraction.

AIMS: Treatment of patients with systemic cardiac implantable electronic device (CIED) infection with large lead vegetations is challenging and associated with relevant morbidity and mortality. To avoid complications from open surgical extraction, a novel approach with percutaneous aspiration of large vegetations prior to transvenous lead extraction was instituted. The results of this treatment concept were retrospectively analysed in this multicentre study. METHODS AND RESULTS: One hundred and one patients [mean age 68.2 ± 13.1 (30-92) years] were treated in four centres for endovascular CIED infection with large lead vegetations. Mean lead vegetation size was 30.7 ± 13.5 mm. Two hundred and forty-seven leads were targeted for extraction (170 pacemaker leads, 77 implantable cardioverter-defibrillator leads). Mean lead implant duration was 81.7 (1-254) months. The transcatheter aspiration system with a specialized long venous drainage cannula and a funnel-shaped tip was based on a veno-venous extracorporeal circuit with an in-line filter. The aspiration of vegetations showed complete procedural success in 94.0% (n = 95), partial success in 5.0% (n = 5). Three major complications (3.0%) were encountered. Complete procedural success (per lead) of the subsequently performed transvenous lead extraction procedure was 99.2% (n = 245). Thirty-day mortality was 3.0% (n = 3). Five patients (5.0%) died in the further course on Days 51, 54, 68, 134, and 182 post-procedure (septic complications: n = 4; heart failure: n = 1). CONCLUSION: The percutaneous aspiration procedure is highly effective and is associated with a low complication profile. The aspiration of vegetations immediately prior and during the lead extraction procedure may avoid septic embolization into the pulmonary circulation. This may potentially lead to a long-term survival benefit.

A combination of rare complications 3 years after a dual-chamber pacemaker implantation.

Late perforation of the atrial wall after pacemaker implantation frequently remains asymptomatic but may cause chest pain, dyspnea or syncope. Perforation can also lead to rarer complications such as hemoptysis and pneumopericardium. We present the case of a patient who developed progressive hemoptysis 3 years after a dual-chamber pacemaker implantation. Pacemaker interrogation showed stable impedance of the right atrial lead and stable pacing threshold values. CT revealed perforation of the right atrial wall by the RA-lead with consecutive pneumopericardium and diffuse lung bleeding of the right middle lobe. The patient was hemodynamically stable at all times. The right atrial lead was transvenously extracted and replaced without any further complications.