Implantation Procedure Research Articles

Experience in the development of a system for repeated prosthetic heart valves

The failure of heart valve bioprostheses, requiring repeated intervention to replace them, is a serious drawback that narrows the scope of such devices. The present study demonstrates the experimental investigation of a medical device designed to partially solve the problem of repeated interventions on heart valves, primarily with an emphasis on reducing the duration and trauma of such procedures due to the sutureless balloon implantation method of the «valvein- valve» method.Material and methods. The paper presents a series of in silico, in vitro and in vivo experiments to evaluate various aspects of the device under development. Numerical modeling of the final shape setting to the supporting frame of the heart valve prosthesis to select the most promising concept for prototyping was carried out in the Abaqus/CAE (Dassault Systèmes, France) based on the finite element method. The selected optimal support frame model was prototyped in the form of a series of prosthesis samples of four standard sizes for hydrodynamic studies of quantitative characteristics in vitro. The study was carried out in the Vivitro Labs unit (Vivitro Labs, Canada), imitating the physiological mode of the heart, the prostheses were examined for the mitral position. The developed prototypes of the device were supplemented with related products, an implant holder and a balloon catheter, after which the proposed method of sutureless fixation was validated in an in vitro implantation procedure on a bovine heart model and a series of in vivo (n = 3) chronic experiments on animals.Results. In the course of numerical simulation, it was shown that in Model No. 3 of the supporting frame of the prosthesis, the smallest stresses occur – with an amplitude of up to 490 MPa. For other concepts (Models No. 1 and No. 2), this indicator was significantly higher, 543 and 514 MPa, respectively. Prototypes obtained on the basis of the selected shape of the support frame demonstrated satisfactory hydrodynamic characteristics: effective hole area 190-261 mm2, regurgitation volume 6–9 ml/cycle, average transprosthetic gradient 4.4–6.4 mmHg, depending on size. The study of the technology of sutureless balloon implantation in an in vitro model of the heart and the subsequent chronic experiment on sheep confirmed the main idea of the system – the possibility of a significant reduction in the duration of repeated prosthetics. It has been shown that the time of suture implantation of the “classic” frame prosthesis of the mitral valve is 23–29 minutes, with a total access time of 41–52 minutes. When implanting the experimental device, the sutureless prosthesis itself took 4–6 minutes, access time 24–29 minutes. At the same time, one-month results of an echocardiographic study of the operation of the prosthesis demonstrated satisfactory hemodynamics.Conclusions. This work demonstrates a consistent series of tests of the system being developed for repeated heart valve replacement, which substantiates some design solutions, confirms the effectiveness and viability of the chosen approach to sutureless minimally invasive implantation.

Complications of pacemaker implantation: mid-term follow-up

Objective: There are very limited data of complications of pacemaker implantation in Vietnam
 Method and Results: From 1/2015 to 12/2019, 1227 consecutive patients with bradycardias, aged 60,39 ± 18,93 years (40,34% male) were underwent the pacemaker implantation. Models of pacemaker is 59,01% with one chamber device and 40,99% with two chambers device. Early complications of pacemaker implantation were pneumothorax of 0,24%, hematoma in pocket of 1,87%, lead dislodgment of 0,57%. Late complications of pacemaker implantation were pocket infection of 0,33%, ventricular arrhythmias of 2,61%, atrial fibrillation of 3,34% and heart failure of 0,33%.
 Conclusion: The pacemaker implantation procedure is safe and very low complications.

Multi-objective design optimization of bioresorbable braided stents

Background and objectivesBioresorbable braided stents, typically made of bioresorbable polymers such as poly-l-lactide (PLLA), have great potential in the treatment of critical limb ischemia, particularly in cases of long-segment occlusions and lesions with high angulation. However, the successful adoption of these devices is limited by their low radial stiffness and reduced elastic modulus of bioresorbable polymers. This study proposes a computational optimization procedure to enhance the mechanical performance of bioresorbable braided stents and consequently improve the treatment of critical limb ischemia. MethodsFinite element analyses were performed to replicate the radial crimping test and investigate the implantation procedure of PLLA braided stents. The stent geometry was characterized by four design parameters: number of wires, wire diameter, initial stent diameter, and braiding angle. Manufacturing constraints were considered to establish the design space. The mechanical performance of the stent was evaluated by defining the radial force, foreshortening, and peak maximum principal stress of the stent as objectives and constraint functions in the optimization problem. An approximate relationship between the objectives, constraint, and the design parameters was defined using design of experiment coupled with surrogate modelling. Surrogate models were then interrogated within the design space, and a multi-objective design optimization was conducted. ResultsThe simulation of radial crimping was successfully validated against experimental data. The radial force was found to be primarily influenced by the number of wires, wire diameter, and braiding angle, with the wire diameter having the most significant impact. Foreshortening was predominantly affected by the braiding angle. The peak maximum principal stress exhibited contrasting behaviour compared to the radial force for all parameters, with the exception of the number of wires. Among the Pareto-optimal design candidates, feasible peak maximum principal stress values were observed, with the braiding angle identified as the differentiating factor among these candidates. ConclusionsThe exploration of the design space enabled both the understanding of the impact of design parameters on the mechanical performance of bioresorbable braided stents and the successful identification of optimal design candidates. The optimization framework contributes to the advancement of innovative bioresorbable braided stents for the effective treatment of critical limb ischemia.

Transcatheter Aortic Valve Implantation with the Portico Valve: 2-Year Outcomes of a Multicenter, Real-World Registry.

The self-expanding, resheathable, repositionable transcatheter aortic heart valve Portico is being used successfully for transcatheter aortic valve implantation procedures (TAVI) in patients with severe aortic stenosis. The aim of this study was to evaluate outcomes at 2 years after TAVI with the Portico valve. Multicenter registry of clinical, echocardiographic and survival data from consecutive patients treated with the Portico TAVI system (Abbott, Chicago, IL, USA) in three cath labs in Northern Greece and Epirus during 2017-2020. The primary end point was all-cause mortality at 24 months. Secondary end points included procedural outcomes (efficacy and safety) and echocardiographic measurements. A total of 90 patients (81 ± 6 years, 50% females, mean age 81 ± 6 years) were included in the registry. The indication for implantation was severe, symptomatic aortic stenosis (NYHA III, IV) in eighty-two (91.1%) and degeneration of a prosthetic aortic valve in eight (8.9%) patients. All patients were categorized as high surgical risk (mean Logistic Euroscore 25.9 ± 10, Euroscore II 7.7 ± 4.4 and STS score 10.8 ± 8.9). The procedure was performed transfemorally in all patients, under general anesthesia in 95.6%, under TOE guidance in 21.1%, with native valve predilatation in 46.7%, and the "resheath" option was used in 31.1% of the cases. The implantation was successful in 97.8% and there was a need for a second valve in 2.2% of the cases. Complications included permanent pacemaker implantation (16.7%), access cite complications (15.6%), arrythmias (23.3%), paravalvular leak (moderate 7.8%, severe 1.1%), acute kidney injury (7.8%), no strokes and one death during the procedure. Aortic valve peak velocity, peak and mean pressure gradients, were significantly reduced after the procedure. All-cause mortality at 1, 12 and 24 months was 4.4%, 6.7% and 7.8%, respectively. TAVI with the Portico system comprises an effective and safe solution for the management of severe, symptomatic aortic stenosis in high-risk surgical patients.

Survival Rate of Dental Implants in the Cleft Area: A Cross-Sectional Retrospective Study.

This study aimed to evaluate the survival rate of osseointegrated implants installed in the cleft area. An extensive data survey was conducted using the medical records of individuals who had implants installed in the cleft area between 1999 and 2020. The variables assessed were age, sex, implant follow-up time, implantation procedures, and rehabilitation with implant-supported prostheses. Data were analyzed in terms of implant survival time, correlating with the factors: age, sex, execution, or no-execution of bone regrafting, the time interval between secondary alveolar bone grafting and regrafting, the time interval between regrafting and implant installation, and the time interval between implant installation and provisional and definitive prosthesis. Data were analyzed with respect to implant survival. χ 2 and Student t tests were used with a 5% significance level. A total of 1295 medical records were analyzed, of which 688 reported implants in cleft areas (56.1% in females, 43.9% in males) with a success rate of 92.73% and a mean follow-up time of 53.2 (±45.0) months. There were no statistically significant differences in the correlation between the survival rate and sex ( P = 0.895, χ 2 test), between the implant survival rate and regrafted area ( P = 0.904, χ 2 test), or between the survival rate and patient age ( P = 0.246, Student t test). The survival rate of implants in the cleft area was 92.73%. Age, sex, and the need for regrafting did not influence the survival rate of implants installed in the cleft area. Clinical studies that evaluate the survival rate of implants installed in patients with cleft maxilla are of great relevance to the dental field.

Computed tomography to guide transcatheter aortic valve implantation.

Since its introduction in 2022, transcatheter aortic valve implantation (TAVI) has revolutionized the treatment and prognosis of patients with aortic stenosis. Robust clinical trial data and awealth of scientific evidence support its efficacy and safety. One of the key factors for success of the TAVI procedure is careful preprocedural planning using imaging. Computed tomography (CT) has developed into the standard imaging method for comprehensive patient assessment in this context. Suitability of the femoral and iliac arteries for transfemoral access, exact measurement of aortic annulus size and geometry as the basis for prosthesis selection, quantification of the spatial relationship of the coronary ostia to the aortic annular plane, and identification of optimal fluoroscopic projection angles for the implantation procedure are among the most important information that can be gained from preprocedural CT. Further research is aimed at improving risk stratification, for example, with respect to annular perforation, periprosthetic aortic regurgitation, and need for postprocedural implantation of apermanent pacemaker.

Real-time pulmonary artery pressure monitoring in heart failure patients: an updated cost-effectiveness analysis.

Previous cost-effectiveness analysis suggests that CardioMEMS is cost-effective compared with usual care for patients with persistent New York Heart Association class III symptoms and at least one heart failure (HF) hospitalization within 12months. The aim of the paper is to perform an update of the cost-effectiveness analysis of CardioMEMS using the most recent data from the published literature. A Microsoft Excel Markov model from a previous UK cost-effectiveness study of CardioMEMS was updated using the clinical effectiveness of pulmonary artery pressure (PAP)-guided treatment derived from the pivotal trials. The model included the device costs (and the implantation procedure and related complications), costs of remote monitoring, costs of HF-related hospitalizations, and costs of usual care. Quality-adjusted life years (QALYs) were estimated based on utilities from pivotal trials and published literature. Cost-effectiveness results were estimated as incremental cost per QALY gained of CardioMEMS compared with usual care. Scenario analyses were also performed using data from real-world studies that showed a significant decrease in HF-related hospitalizations. In the base case analysis over a time horizon of 10years, PAP-guided HF therapy increased cost compared with usual care by £6337 (i.e. from £22770 in usual care to £29107 in PAP-guided HF therapy) and the QALYs per patient for usual care and PAP-guided patients were 2.62 and 2.94, respectively, reflecting an increase of 0.32 QALYs with PAP-guided treatment. The resultant incremental cost-effectiveness ratio (ICER), the ratio between incremental costs and the QALYs, is estimated at £19761/QALY. Scenario analyses suggest that the ICER for CardioMEMS can range from being dominant to £27910/QALY. Probabilistic sensitivity analyses suggested that PAP-guided HF therapy has 81.9% probability of being cost-effective at a threshold of £30000/QALY. Our model suggests that CardioMEMS is likely to be cost-effective in the United Kingdom, at the currently considered thresholds of £20000-30000/QALY.

Nanomechanical Characterization of Bone Quality Depending on Tissue Age via Bimodal Atomic Force Microscopy

Characterization of bone quality during the healing process is crucial for successful implantation procedures and patient comfort. In this study, a bone implant specimen that underwent a 4-week healing period was investigated. Bimodal atomic force microscopy (AFM) was employed to simultaneously obtain the morphology and elastic modulus maps of the newly formed and pre-existing bone regions within the sample. Results indicate that the new bone matrix possessed lower mineralization levels and presented larger, uneven mineral grains, exhibiting the attributes of a woven bone. On the other hand, the old bone matrix exhibited a more uniform and mineralized structure, which is characteristic of lamellar bones. The new bone had a lower overall elastic modulus than the old bone. Bimodal AFM further confirmed that the new bone displayed three regions comprising unmineralized, partially mineralized, and fully matured sections, which indicate a turbulent change in its composition. Meanwhile, the old bone exhibited two sections comprising partially mineralized and matured bone parts, which denote the final phase of mineralization. This study provides valuable insights into the morphological and nanomechanical differences between the old and new bone matrixes and presents a novel approach to investigate bone quality at different phases of the bone-healing process.

Real-world evidence for the use of subcutaneous implantable cardioverter-defibrillators in China: Asingle-center experience.

Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have been shown to be non-inferior to transvenous ICDs in the prevention of sudden cardiac death (SCD), but there is still alack of evidence from clinical trials in China. We investigated whether S‑ICD implantation in the Chinese population is safe and feasible and should be promoted in the future. Consecutive patients undergoing S‑ICD implantation at our center were enrolled in this retrospective study. Data were collected within the median follow-up period of 554days. Data concerning patient selection, implantation procedures, complications, and episodes of shock were analyzed. In total, 70.2% of all 47patients (median age = 39years) were included for secondary prevention of SCD with different etiologies. Vector screening showed that 98% of patients were with > 1 appropriate vector in all postures. An intraoperative defibrillation test was not performed on six patients because of the high risk of disease deterioration, while all episodes of ventricular fibrillation induced post implantation were terminated by one shock. As expected, no severe complications (e.g., infection and device-related complications) were observed, except for one case of delayed healing of the incision. Overall, 15patients (31.9%) experienced appropriate shocks (AS) with all episodes terminated by one shock. Two patients (4.3%) experienced inappropriate shocks (IAS) due to noise oversensing, resulting in ahigh Kaplan-Meier IAS-free rate of 95.7%. Based on appropriate patient selection and standardized implantation procedures, this real-world study confirmed the safety and efficacy of S‑ICD in Chinese patients, indicating that it may help to promote the prevention of SCD in China.

Five-Year Outcomes After Implantation of a Scaffold-Free Tissue-Engineered Construct Generated From Autologous Synovial Mesenchymal Stromal Cells for Repair of Knee Chondral Lesions.

In an earlier study, a scaffold-free tissue-engineered construct (TEC) derived from autologous synovial membrane mesenchymal stromal cells (MSCs) was developed and demonstrated to be safe and effective for cartilage repair at 2 years postoperatively. To investigate clinical outcomes and magnetic resonance imaging (MRI) findings at 5 years after implantation. Case series; Level of evidence, 4. This was an observational first-in-human study limited to 5 patients (age, 28-46 years) with symptomatic knee chondral lesions (size, 1.5-3.0 cm2) on the medial femoral condyle, lateral femoral condyle, or femoral groove. Synovial MSCs were isolated from arthroscopic biopsy specimens and cultured to develop a TEC that matched the lesion size. The TECs were then implanted into chondral defects without fixation and assessed at up to 5 years postoperatively. The patients were clinically evaluated using the visual analog scale for pain, Lysholm score, Tegner score, and Knee injury and Osteoarthritis Outcome Score. An MRI scan evaluation was also performed for morphologic and compositional quality of the repair tissue at both 2 and 5 years of follow-up. All clinical scores were significantly improved from the preoperative evaluation to the 2- and 5-year follow-ups and the results were stable over time. The MRI scan evaluation showed cartilage defects filled with newly generated tissues with good tissue integration to adjacent host cartilage over time. The cartilage thickness and surface smoothness of the repair cartilage were maintained up to 5 years postoperatively. The MOCART (magnetic resonance observation of cartilage repair tissue) 2.0 Knee Scores remained high at 5 years, although the total points decreased slightly. The results highlight the efficacy and feasibility of autologous scaffold-free TEC derived from synovial MSCs for regenerative cartilage repair via a sutureless and simple implantation procedure, showing good clinical outcomes and MRI findings with stable results at midterm follow-up. Further follow-up will be needed to assess the long-term quality of the repair tissue.

Isokinetic Training After A Matrix-Induced Autologous Chondrocyte Implantation Procedure: A Case Study

BACKGROUND: Matrix-induced autologous chondrocyte implantation (MACI) is an effective surgical procedure to repair defective cartilage. CASE PRESENTATION: This case study examined the influence of an isokinetic training program on muscle strength, size, and vertical jump performance for a young female adult after a MACI procedure. The subject completed an isokinetic training program 3 days/week for 12 weeks. Weekly assessments included isometric and isokinetic assessments of thigh muscle strength and power, ultrasound assessments of quadriceps and hamstrings muscle size, and force plate assessments of bilateral and unilateral vertical jump performance. OUTCOME AND FOLLOW-UP: Thigh muscle size 15% to 23%. Thigh muscle strength increased from 19% to 105%, whereas power increased from 29% to 121%. Bilateral and unilateral vertical jump performance increased from 6% to 93%. DISCUSSION: This study demonstrates that a 12-week isokinetic training program appears effective for increasing muscle strength, size, and vertical jump performance within the year following a MACI procedure. JOSPT Cases 2023;3(3):150-157. Epub: 20 June 2023. doi:10.2519/josptcases.2023.11617

Four-year visual outcomes and optical quality of SMILE and implantable collamer lens V4c (EVO-ICL) implantation for high myopia: a retrospective study

BackgroundTo compare the 4-year visual outcomes of implantable collamer lens V4c (EVO-ICL) implantation and small incision lenticule extraction (SMILE) for high myopia and astigmatism.MethodsThis retrospective case study included 64 eyes of 40 patients. These patients with preoperative manifest refraction spherical equivalent (SE) between − 6.00 and − 10.00 diopters (D) were screened from the database of SMILE and EVO-ICL implantation procedures in 2015. The ICL group [32 eyes of 19 patients (mean age, 29.6 ± 6.3 years); mean SE, -8.71 ± 1.06 D] and SMILE group [32 eyes of 21 patients (mean age, 27.7 ± 5.6 years); mean SE, -8.35 ± 0.65D] were compared. All patients were then prospectively examined at a four-year follow-up for routine postoperative examinations, higher-order ocular aberrations, retinal image quality and a questionnaire.ResultsThe safety indexes were 1.15 ± 0.14 and 1.22 ± 0.21 (P = 0.36) for the SMILE and ICL groups, respectively. No eyes lost two or more lines of CDVA in either group. The efficacy indexes were 0.97 ± 0.16 and 0.96 ± 0.19 (P = 0.87), respectively. Twenty-three eyes (72%) in ICL and 26 eyes (81%) in SMILE groups were within ± 0.5 D of the attempted SE (P < 0.01). ICL-treated eyes had significantly less spherical aberration and coma (P < 0.01 and < 0.05, respectively) postoperatively. Halos were the prevalent visual disturbance in both groups.ConclusionSMILE and EVO-ICL implantation provided safe and effective correction of high myopia. SMILE showed slightly better long-term predictability. Mild postoperative visual disturbances were observed after ICL and SMILE at 4-year follow-up.

Role of nursing in the implantation of the injectable holter

Abstract Funding Acknowledgements Type of funding sources: None. Main funding source(s): No Introduction The injectable Holter monitor is a useful tool in the evaluation of patients with recurrent syncope of unknown etiology and in patients with suspected embolic paroxysmal AF. This device monitors heart rhythm for 2-3 years. In our center, the implantation and follow-up of this type of patient is carried out exclusively by nursing, with three centers in Andalusia performing this type of procedure. The objective is to describe the injectable holter implant procedure prepared by nursing. Material and Method Through the bibliographic search in the CUIDEN and PubMed databases, a procedure for the implantation of an injectable Holter monitor by nursing has been developed. The types of Holter that are implanted in the Hemodynamics Unit, the implantation procedure, as well as the necessary material are described. When an injectable Holter monitor is implanted in a patient, a series of steps are followed, such as checking them the next day, conducting health education, as well as delivering the remote monitoring device. Results Since 2010, 266 devices have been implanted, with the nursing staff being fully responsible for both implanting and monitoring them. In the insertion procedure, the previous preparation of the patient, information, the necessary material for the implant, procedure and activation of the device by means of a programmer are highlighted. After the implant, monitoring and remote control are performed by the nursing staff for functional tests. Conclusions The complete approach to the implantation and follow-up of the injectable Holter monitor by nursing has allowed us to grow, helping closely in the diagnosis and treatment of heart rhythm disorders. The utility in the early detection of cardiac events in the injectable Holter monitor is a leap in the quality of life of patients, in the optimization of resources and in response time.

Cost-effectiveness analysis of epidural morphine/ropivacaine treatment in patients with cancer pain.

Cancer pain is one of the main causes of human suffering, which can generate disabilities and compromise quality of life, giving rise to several psychosocial and economic consequences. This quantitative study sought to perform a cost-effectiveness pharmacoeconomic analysis to assess the impact of implanting epidural morphine associated with ropivacaine treatment in gastrointestinal cancer patients with pain that is difficult clinical control, compared with conventional oral treatment. The study population consisted of 24 patients with gastrointestinal neoplasia who underwent treatment for cancer pain that was difficult to clinically control. 12 patients each were recruited into the control and intervention groups, respectively. While patients in the control group were administered drug treatment orally, patients in the intervention group underwent a surgical procedure for subcutaneous implantation of a catheter that allowed epidural administration of morphine and ropivacaine. For pain assessment, the Visual Analogue Scale was applied. Data analysis had a descriptive character of costs, taking into account the costs for the year 2021. The study perspective was the Brazilian public healthcare provider, referred to as the Unified Health System (Sistema Único de-SUS in Portuguese). Costs were computed over the time horizon corresponding to the duration of treatment, from the first medical consultation (when the treatment was defined) to the end (end of treatment, disease progression, or death). Treatment duration was divided into three phases (first 60 days, support with palliative care, and end-of-life care). To assess the robustness of the economic analysis, sensitivity analyses were performed, considering the effectiveness of pain reduction on the Visual Analogue Scale, and a comparison of results using the median prices of pharmaceutical components used in the study. The mean age of patients was 59.3 years. The results from the cost-effectiveness analysis showed the epidural morphine/ropivacaine treatment to be more effective with regard to pain reduction on the pain scale, particularly for end-of-life care, when compared to the conventional oral treatment, however, at a significantly higher cost. From the accomplishment of this research, it was observed that the application of the pain assessment scale is a way to better interpret and understand the patient's pain, facilitating care planning and decision-making by health professionals, as well as monitoring the effectiveness of the proposed new treatment. To present a better cost-effectiveness ratio, a reduction in the cost of the new epidural technology or an increase in the value of the existing oral intervention would be required. However, the latter is not feasible and unlikely to occur. A value judgement to decide whether the incremental benefit associated with the use of the new intervention is worth the extra cost will have to be made by the healthcare provider. Interventions that can relieve cancer pain symptoms should be investigated continuously, in search of evidence to support clinical practice and promote better quality of life for patients.

Incidental lymphadenopathy in renal transplantation.

Iliac lymphadenectomy is performed to provide anastomotic access during the vascular implantation procedure in renal transplantation. Iliac lymph nodes (LNs) are often enlarged, but there are no standardised guidelines for the management of incidentally enlarged LNs during transplantation. We aimed to evaluate histological findings of LNs sent for examination at our unit. Patients were evaluated in two distinct date cycles. In the first cycle, lymphadenectomy and histological assessment were performed at the discretion of the transplanting surgeon. In the second cycle, all incidentally enlarged LNs were sent for histological assessment, regardless of size. In the first cycle (n = 76), 11 patients (14.47%) had incidentally enlarged iliac LNs on lymphadenectomy and histology showed only reactive changes. In the second cycle (n = 165), eight patients (4.85%) had incidentally enlarged LNs on lymphadenectomy. One patient was found to have mature B cell chronic lymphocytic leukaemia. The patient was referred to haematology and a "watch and wait" approach was taken, with the patient still alive at last follow-up (511 days post-transplantation). There are currently no published guidelines on the management of incidentally enlarged iliac LNs during transplantation. Current literature suggests that clinically significant lymphadenopathy needs to be investigated in all patients. Based on our centre's experience of a 5.26% (1 in 19) positive pathological LN sampling, we recommend that all incidental LNs with suspicious features and/or that are greater than 10mm in diameter should be considered for histological, microbiological and molecular assessment as appropriate.

Postapproval Study of a Subcutaneous Implantable Cardioverter-Defibrillator System

BackgroundThe subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to avoid complications related to transvenous implantable cardioverter-defibrillator (TV-ICD) leads. Device safety and efficacy were demonstrated previously with atypical clinical patients or limited follow-up. ObjectivesThe S-ICD PAS (Subcutaneous Implantable Cardioverter-Defibrillator System Post Approval Study) is a real-world, multicenter, registry of U.S. centers that was designed to assess long-term S-ICD safety and efficacy in a diverse group of patients and implantation centers. MethodsPatients were enrolled in 86 U.S. centers with standard S-ICD indications and were observed for up to 5 years. Efficacy endpoints were first and final shock efficacy. Safety endpoints were complications directly related to the S-ICD system or implantation procedure. Endpoints were assessed using prespecified performance goals. ResultsA total of 1,643 patients were prospectively enrolled, with a median follow-up of 4.2 years. All prespecified safety and efficacy endpoint goals were met. Shock efficacy rates for discrete episodes of ventricular tachycardia or ventricular fibrillation were 98.4%, and they did not differ significantly across follow-up years (P = 0.68). S-ICD–related and electrode-related complication-free rates were 93.4% and 99.3%, respectively. Only 1.6% of patients had their devices replaced by a TV-ICD for a pacing need. Cumulative all-cause mortality was 21.7%. ConclusionsIn the largest prospective study of the S-ICD to date, all study endpoints were met, despite a cohort with more comorbidities than in most previous trials. Complication rates were low and shock efficacy was high. These results demonstrate the 5-year S-ICD safety and efficacy for a large, diverse cohort of S-ICD recipients. (Subcutaneous Implantable Cardioverter-Defibrillator [S-ICD] System Post Approval Study [PAS]; NCT01736618)

Peri-Procedural Management of Direct-Acting Oral Anticoagulants (DOACs) in Transcatheter Miniaturized Leadless Pacemaker Implantation.

Data on peri-operative management of direct-acting oral anticoagulants (DOACs) during transcatheter pacing leadless system (TPS) implantations remain limited. This study aimed to evaluate a standardized DOAC management regime consisting of interruption of a single dose prior to implantation and reinitiation within 6-24 h; also, patient clinical characteristics associated with this approach were identified. Consecutive patients undergoing standard TPS implantation procedures from two Swiss tertiary centers were included. DOAC peri-operative management included the standardized approach (Group 1A) or other approaches (Group 1B). Three hundred and ninety-two pts (mean age 81.4 ± 7.3 years, 66.3% male, left ventricular ejection fraction 55.5 ± 9.6%) underwent TPS implantation. Two hundred and eighty-two pts (71.9%) were under anticoagulation therapy; 192 pts were treated with DOAC; 90 pts were under vitamin-K antagonist. Patients treated with DOAC less often had structural heart disease, diabetes mellitus, and advanced renal failure. The rate of major peri-procedural complications did not differ between groups 1A (n = 115) and 1B (n = 77) (2.6% and 3.8%, p = 0.685). Compared to 1B, 1A patients were implanted with TPS for slow ventricular rate atrial fibrillation (AF) (p = 0.002), in a better overall clinical status, and implanted electively (<0.001). Standardized peri-procedural DOAC management was more often implemented for elective TPS procedures and did not seem to increase bleeding or thromboembolic adverse events.

Hearing and speech outcomes in children with cochlear nerve hypoplasia who underwent cochlear implantation

Background: Data on hearing and speech outcomes following cochlear implantation in prelingual sensorineural hearing loss (SNHL) children with cochlear nerve hypoplasia, especially in Indonesia, is still limited. Purpose: To evaluate the hearing and speech function of prelingual SNHL children who had undergone cochlear implantation. Method: A retrospective cross-sectional study was conducted on 28 children who had undergone cochlear implantation procedures at the Department of Otorhinolaryngology and Head and Neck Surgery, Dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia, for more than 12 months. The hearing and speech function of the subjects were assessed using the modified Categories of Auditory Performance (CAP-II) and the speech intelligibility rating (SIR) scores. Result: Children with cochlear nerve hypoplasia showed an increase in CAP-II and SIR scores after using cochlear implants for more than 12 months (versus pre-surgery, high CAP score [≥5]: 89.3% [25/28 children] vs 3.6% [1/28 children] and high SIR score [≥3]: 82.1% [23/28 children] vs 7.1% [2/28 children]; both p&lt;0.001). Post-operative CAP-II and post-operative SIR scores were highly positively correlated (r=0.705, p&lt;0.001). Type of cochlear nerve hypoplasia (unilateral vs bilateral) were not significantly associated with post-operative CAP-II and SIR scores (p=0.382 and p=0.459, respectively). Conclusion: Prelingual SNHL children with cochlear nerve hypoplasia may still get the benefit from cochlear implantation, as shown by a remarkable improvement in hearing and speech function as assessed with the CAP-II and SIR scores.&#x0D; Keywords: auditory perception, cochlear implants, cochlear nerve hypoplasia, prelingual sensorineural hearing loss, speech intelligibility

Guided implantation of a leadless left ventricular endocardial electrode and acoustic transmitter using computed tomography anatomy, dynamic perfusion and mechanics, and predicted activation pattern

The WiSE-CRT System (EBR systems, Sunnyvale, CA) permits leadless left ventricular pacing. Currently, no intraprocedural guidance is used to target optimal electrode placement while simultaneously guiding acoustic transmitter placement in close proximity to the electrode to ensure adequate power delivery. The purpose of this study was to assess the use of computed tomography (CT) anatomy, dynamic perfusion and mechanics, and predicted activation pattern to identify both the optimal electrode and transmitter locations. A novel CT protocol was developed using preprocedural imaging and simulation to identify target segments (TSs) for electrode implantation, with late electrical and mechanical activation, with ≥5 mm wall thickness without perfusion defects. Modeling of the acoustic intensity from different transmitter implantation sites to the TSs was used to identifythe optimal transmitter location. During implantation, TSs wereoverlaid on fluoroscopy to guide optimal electrode locationthat were evaluated by acute hemodynamic response (AHR) by measuring the maximal rate of left ventricular pressure rise with biventricular pacing. Ten patients underwent the implantation procedure. The transmitter could be implanted within the recommended site on the basis of preprocedural analysis in all patients. CT identified a mean of 4.8 ± 3.5 segments per patient with wall thickness < 5 mm. During electrode implantation, biventricular pacing within TSs resulted in a significant improvement in AHR vs non-TSs (25.5% ± 8.8% vs 12.9% ± 8.6%; P < .001). Pacing in CT-identified scar resulted in either failure to capture or minimal AHR improvement. The electrode was targeted to the TSs in all patients and was implanted in the TSs in 80%. Preprocedural imaging and modeling data with intraprocedural guidance can successfully guide WiSE-CRT electrode and transmitter implantation to allow optimal AHR and adequate power delivery.

Cardiac contractility modulation therapy in patients with implanted cardiac resynchronization therapy: results of the 2 year follow-up

Aim. Cardiac contractility modulation (CCM) is a device therapy for patients with heart failure with reduced ejection fraction (HFrEF), most of the data on its programming are concerned patients with narrow QRS and of limited follow up. Our aim was to propose programming approach for Optimizer device in setting of wide QRS complex and fragmented ventricular local activation.Methods. We enrolled 11 patients with HFrEF (median age, 8 males, median NYHA class 3) and LBBB-related wide QRS complex, who underwent Optimizer™ device implantation. Three patients got Optimizer™ IV system and eight patients were implanted Optimizer™ Smart. Ten patients were previously implanted with CRT-D due to HFrEF and LBBB; one patient received CRT-D after Optimizer™ implantation.Results. During the implantation procedure ventricular local sense (LS) channel signal fragmentation was detected in all patients. In five patients signal detection was optimized by lead relocation. In six patients LS signal sensitivity limitations were resolved by programming. At two-year follow-up survival 4 patients died of noncardiac causes (1 intracranial hemorrhage, 1 gastrointestinal bleeding and 2 - terminal kidney failure). At 12-month follow-up we observed a non-significant improvement in 6-minute walking distance (300 vs 305, p=0.093), NYHA class (2.75 vs 2, p=0.085), MLHF score (53 vs 42, p=0.109) and left ventricular ejection fraction (LVEF) (30 vs 33.5, p=0.212).Conclusion. CCM system implantation is feasible and safe in patients with HFrEF and LBBB-related wide QRS complex. Device programming maneuvers can resolve the challenges of ventricular local signal detection in these patients.