Underwent Device Implantation Research Articles

Urinary Continence Restoration Through an Endourethral Device: A 3-Month Pilot Study on 10 Patients.

Background: Stress urinary incontinence (SUI) is a widespread and frustrating condition that affects millions of people worldwide, with severe consequences on patients' quality of life and health care systems' costs. Currently, the most severe cases of SUI are treated using implanted (and rather invasive) extraurethral artificial sphincters. The authors propose an innovative, minimally invasive endourethral device for the treatment of SUI. Methods: Ten patients with SUI were enrolled in three Italian centers and underwent device implantation. After 10, 30, 60, and 90 days, correct device position was confirmed by ultrasonography. Improvements in continence and quality of life were evaluated through a 24-hour pad-test, an International Consultation on Incontinence Questionnarie-Short Form (ICI-Q) and a custom checklist. The device was explanted after 90 days. Results: The proposed device was successfully implanted and explanted in 8 out of 10 patients. The results of the pad-test, ICI-Q, and custom checklist demonstrated remarkable improvements in continence (median improvement: 82% with respect to the initial condition) and quality of life (mean reduction of the impact of urine losses on the quality of life: 61%). No major pain or discomfort was reported. Conclusions: The results demonstrate the efficacy of the proposed endourethral artificial sphincter in addressing SUI. The proposed device was successfully implanted and explanted in a short time (∼10 minutes) without intrinsic side effects and without triggering pain or discomfort.

The Role of TOMM40 in Cardiovascular Mortality and Conduction Disorders: An Observational Study.

Aims: TOMM40 single nucleotide polymorphism (SNP) rs2075650 consists of allelic variation c.275-31A > G and it has been linked to Alzheimer disease, apolipoprotein and cholesterol levels and other risk factors. However, data on its role in cardiovascular disorders are lacking. The first aim of the study is to evaluate mortality according to TOMM40 genotype in a cohort of selected patients affected by advanced atherosclerosis. Second aim was to investigate the relationship between Xg and AA alleles and the presence of conduction disorders and implantation of defibrillator (ICD) or pacemaker (PM) in our cohort. Materials and Methods: We enrolled 276 patients (mean age 70.16 ± 7.96 years) affected by hemodynamic significant carotid stenosis and/or ischemia of the lower limbs of II or III stadium Fontaine. We divided the population into two groups according to the genotype (Xg and AA carriers). We evaluated several electrocardiographic and echocardiographic parameters, including heart rate, rhythm, presence of right and left bundle branch block (LBBB and RBBB), PR interval, QRS duration and morphology, QTc interval, and left ventricular ejection fraction (LVEF). We clinically followed these patients for 82.53 ± 30.02 months and we evaluated the incidence of cardiovascular events, number of deaths and PM/ICD implantations. Results: We did not find a difference in total mortality between Xg and AA carriers (16.3 % vs. 19.4%; p = 0.62). However, we found a higher mortality for fatal cardiovascular events in Xg carriers (8.2% vs. 4.4%; HR = 4.53, 95% CI 1.179-17.367; p = 0.04) with respect to AA carriers. We noted a higher percentage of LBBB in Xg carriers (10.2% vs. 3.1%, p = 0.027), which was statistically significant. Presence of right bundle branch block (RBBB) was also higher in Xg (10.2% vs. 4.4%, p = 0.10), but without reaching statistically significant difference compared to AA patients. We did not observe significant differences in heart rate, presence of sinus rhythm, number of device implantations, PR and QTc intervals, QRS duration and LVEF between the two groups. At the time of enrolment, we observed a tendency for device implant in Xg carriers at a younger age compared to AA carriers (58.50 ± 0.71 y vs. 72.14 ± 11.11 y, p = 0.10). During the follow-up, we noted no statistical difference for new device implantations in Xg respect to AA carriers (8.2% vs. 3.5%; HR = 2.384, 95% CI 0.718-7.922; p = 0.156). The tendency to implant Xg at a younger age compared to AA patients was confirmed during follow-up, but without reaching a significant difference(69.50 ± 2.89 y vs. 75.63 ± 8.35 y, p = 0.074). Finally, we pointed out that Xg carriers underwent device implantation 7.27 ± 4.43 years before AA (65.83 ± 6.11 years vs. 73.10 ± 10.39 years) and that difference reached a statistically significant difference (p = 0.049) when we considered all patients, from enrollment to follow-up. Conclusions: In our study we observed that TOMM40 Xg patients affected by advanced atherosclerosis have a higher incidence of developing fatal cardiovascular events, higher incidence of LBBB and an earlier age of PM or ICD implantations, as compared to AA carriers. Further studies will be needed to evaluate the genomic contribution of TOMM40 SNPs to cardiovascular deaths and cardiac conduction diseases.

Leadless ultrasound-based cardiac resynchronization system in heart failure results from the SOLVE-CRT randomised sub-study and the primary population patient cohort

Abstract Background Despite the well-established role of CRT in heart failure, major limitations of CRT include an occasional incidence of unsuccessful coronary sinus (CS) lead placement, one third non-responders in conventional CRT patients and higher complications risk in CRT upgrade procedures. The WiSE® CRT System (EBR Systems, Inc) is designed to overcome these limitations. Prior non-randomized studies with the WiSE System have shown high implant success rates and improvement in LV remodeling and heart failure symptoms. Objectives The pivotal SOLVE-CRT study is comprised of two parts: a randomized part and the subsequent single-arm part enrolled during the pandemic. The primary safety endpoint is freedom from Type I (device & procedure-related) complications through 6 months and primary efficacy endpoint is the mean relative (%) change in left ventricular end systolic volume (LVESV) from baseline to 6 months. Method Between Jan. 2018 and Mar. 2020 the randomized part enrolled 108 participants for three indications: non-responders (NR), previously untreated, including acute and chronic lead failures (PU), and high-risk upgrades (HRU). All underwent device implantation and were then randomized in 1:1 ratio to Treatment (system turned ON) or Control (system turned OFF) groups. In the single arm, 75 participants had been enrolled within two indications: PU and HRU. The efficacy analysis of the entire randomised cohort included 99 participants (PU, HRU, NR). For the primary indication sub-population, 57 participants (PU, HRU) were analysed. Results Randomized Group: Results were available for 91 of the 99 patients. Significant improvements were seen between the Treatment and Control groups with a mean reduction in LVESV (-14.6% vs -5.2%, p=0.005), mean reduction in LVEDV (-8.1% vs -3.0%, p=0.027), mean increase in LVEF (5.4% vs 2.4%, p=0.048) and mean reduction in QRS (-41.9ms vs -1.7ms, p=0.001). Primary Indication Sub-Population Group: The primary indication sub-population also saw significant improvements between Treatment and Control group with a mean reduction in LVESV (-18.2% vs -3.1%, p=0.002), mean reduction in LVEDV (-11.6% vs -2.1%, p=0.004), mean increase in LVEF (5.7% vs 1.1%, p=0.025) and mean reduction in QRS (-38.0ms vs -3.1ms, p<0.001). Conclusion This pivotal SOLVE-CRT trial demonstrates that leadless, ultrasound-based endocardial pacing for heart failure is feasible and efficacious showing evidence of left ventricular remodelling and electrical response after 6 month in the primary population as well as in the sub-study group. Picture 1: Efficacy entire randomised population Picture 2: Efficacy primary indications population

The impact of clinical audits on patient radiation exposure for device procedures

Abstract Background Clinical audits aim to ensure ideal use of ionizing radiation in clinical practice. Since it became mandatory by Swiss law in 2018, such an audit also took place in our Cardiac Pacing and Electrophysiology Division at the University Heart Center. Purpose To establish local diagnostic reference levels (DRLs) for specific procedures and to examine if patient radiation exposure was reduced after the clinical audit. Methods Retrospective cohort study including patients from October 2018 to October 2020 who underwent device implantation, including pacemakers, implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy (CRT), or lead extraction / device explantation. Main measures to reduce radiation exposure after the audit were lower pulsed fluoroscopy frame rates and dose characteristics at baseline. Patient radiation exposure was evaluated with the dose-area product (DAP), cumulative dose, fluoroscopy time, and the number of cine acquisitions. Secondary endpoints included the effective dose, the acute procedural success rate and 30-day complications. Data were collected from a dose management system and cross-checked for accuracy with the patient information system. The third quartiles were set as local DRLs. Data before and after the clinical audit were compared. Results A total of 541 patients (45.7 % before the audit, 54.3% after the audit) were included. 28.3% had a conventional pacemaker, 22.0% a leadless pacemaker, 21.1% an ICD, and 17.2% a CRT implantation. Lead extraction / device explantation was undergone by 11.5% of patients. The local DRLs (including all procedures before and after the audit) for the DAP were significantly lower as compared to national DRLs (6.2 dGy.cm2 versus 300 dGy.cm2 for conventional pacemakers; 7.6 dGy.cm2 versus 200 dGy.cm2 for ICDs, 203 dGy.cm2 versus 570 dGy.cm2 for CRTs). After the audit, DAP (Figure 1), cumulative dose, effective dose and the number of cine acquisition significantly decreased for conventional pacemakers (p-value ≤ 0.04), whereas no significant differences were observed for the other procedures. The acute procedural success rate (98.4 vs 98.9%) and the 30-day complications (4.0 vs 7.8%) were not significantly different before and after the audit. Conclusions The clinical audit in our institution led to a significant reduction of radiation exposure for patients during pacemaker implantations. Regarding DRLs, local values were far below national DRLs, which suggests that national DRLs need to be updated more regularly. Our study highlights the importance of clinical audits and the need for more research in this field.

Clinical outcomes of cardiac devices in heart failure patients hospitalized with COVID-19: insights from the united states national inpatient database

Abstract Background COVID-19 has caused global impact especially in patients with cardiac devices(CD). Moreover, since the onset of the COVID-19 pandemic, physicians have suspended nonurgent procedures. Scarce date is available with respect to CD implantations in patients with active COVID-19. Purpose We aimed to investigate the impact of COVID-19 on implantation rates and clinical outcomes in heart failure (HF) patients hospitalized for COVID-19. Methods Data from National Inpatient Sample database from 2020 was used to identify hospitalizations for COVID in HF patients. Clinical outcomes of CD implantations were compared using univariate and multivariate logistic regression analysis. Results From March-December 2020, a total of 20,426 CD were performed in HF patients in the United States, of which 0.9 % were among those with active COVID-19 infection. Patients with COVID were younger, more hispanic and black population, and had a higher prevalence of comordities such as ventricular fibrillation and complete heart block when compared to patients without COVID. CD implantation in patients with COVID had significantly increased in-hospital mortality, longer lengths of stay, higher hospitalization costs, and outcomes such as incidence of acute stroke, thromboembolism, and sepsis. Device related complications and the need for revisions were comparable in the two cohorts. After adjustment for baseline characteristics, COVID cohort had increased odds of in-hospital mortality. Conclusion Patients with active COVID-19 infection who underwent device implantation had increased in-hospital mortality, longer lengths of stay and higher hospitalization costs with comparable outcomes of device complications.Figure 1Figure 2

Single-Center Outcomes of WATCHMAN™ Implantation with Comparison to Oral Anticoagulant and Dual Antiplatelet Therapy.

Background The WATCHMAN™ device is aFood and Drug Administration(FDA)-approved device that reduces the risk of stroke from atrial fibrillation (AF) in those who have a contraindication to taking oral anticoagulation. A key aspect of this device implantation is the choice of medical therapy in the months after device implantation with Vitamin K antagonist oral anticoagulants (OAC) being the mainstay of therapy but dual antiplatelet therapy (DAPT) poses as a potential alternative to patients who have a contraindication to OAC use. Methods Our single-center study retroactively followed 150 patients post-WATCHMAN™ implantation and evaluated outcomes at 12 months post-implantation in two cohorts, those treated with OAC or DAPT. Our results were obtained via chart review of a single-center electronic medical records system. Results In our study, 67.33% of study patients were males and 49.33% were on OAC compared to 36.00% that were on DAPT. Ten patients were not able to undergo device implantation. With this analysis, we found similarly low rates of complications such as stroke and device-associated thrombosis (DAT) in both groups. Our DAPT cohort did have a higher number of gastrointestinal (GI) bleeding but this was not significant in our analysis. Discussion Our study compares to larger trials that show similar outcomes between OAC and DAPT post-implantation of the WATCHMAN™ device. The increased number of GI bleeding in our DAPT cohort could be the result of the underlying advanced age and comorbidity of that patient cohort. Conclusion Our results suggest that DAPT is a safe alternative to OAC for patients undergoing WATCHMAN™ implantation.

Echocardiographic mechanical dyssynchrony predicts long-term mortality in patients with cardiac resynchronisation therapy

Cardiac resynchronisation therapy (CRT) is an established treatment for patients with symptomatic heart failure with reduced left ventricular ejection fraction (LVEF ≤ 35%; HFrEF) and conduction disturbances (QRS duration ≥ 130 ms). The presence of mechanical dyssynchrony (MD) on echocardiography has been hypothesised to be of predictive value in determining indication for CRT. This study investigated the impact of MD (apical rocking [AR] and septal flash [SF]) on long-term survival in CRT recipients. HFrEF patients (n = 425; mean age 63.0 ± 10.6 years, 72.3% male, 60.7% non-ischaemic aetiology) with a guideline-derived indication for CRT underwent device implantation. MD markers were determined at baseline and after a mean follow-up of 11.5 ± 8.0 months; long-term survival was also determined. AR and/or SF were present in 307 (72.2%) participants at baseline. During post-CRT follow-up, AR and/or SF disappeared in 256 (83.4%) patients. Overall mean survival was 95.9 ± 52.9 months, longer in women than in men (109.1 ± 52.4 vs. 90.9 ± 52.4 months; p < 0.001) and in younger (< 60 years) versus older patients (110.6 ± 53.7 vs. 88.6 ± 51.1 months; p < 0.001). Patients with versus without MD markers at baseline generally survived for longer (106.2 ± 52.0 vs. 68.9 ± 45.4 months; p < 0.001), and survival was best in patients with resolved versus persisting MD (111.6 ± 51.2 vs. 79.7 ± 47.6 months p < 0.001). Age and MD at baseline were strong predictors of long-term survival in HFrEF patients undergoing CRT on multivariate analysis. Novel echocardiography MD parameters in HFrEF CRT recipients predicted long-term mediated better outcome, and survival improved further when AR and/or SF disappear after CRT implantation.Graphical abstract

Worsening tricuspid regurgitation associated with permanent pacemaker and implantable cardioverter-defibrillator implantation: A systematic review and meta-analysis of more than 66,000 subjects

Worsening tricuspid regurgitation (TR) after either permanent pacemaker (PPM) or implantable cardioverter-defibrillator (ICD) implantation is an emerging clinical challenge. Early recognition of this entity is essential in guiding treatment. This meta-analysis was designed to identify the overall incidence and patient-specific predictors of TR post-device implantation. We searched electronic databases from inception to January 2023 for published studies that reported the incidence of TR worsening post-device implantation. The log odds ratio (OR) was used to summarize group differences. Our analysis included 29 studies with 66,590 participants. Patients who underwent device implantation (n = 1008) were significantly more likely to develop worsening TR than controls who did not undergo device implantation (n = 58,605) (OR 3.18; P < .01). In a total of 7777 patients, the pooled incidence of at least 1-grade worsening of TR post-device implantation was 24%. Worsening TR post-device implantation significantly increases mortality (hazard ratio 1.42; P = .02). Larger right atrial area (OR 1.11; P<.01) is significantly associated with an increased risk of worsening TR post-device implantation, while male patients are less likely to develop this complication than female patients (OR 0.74; P < .01). Importantly, there is no statistically significant difference between the type of implanted device (ICD vs PPM) and post-device implantation TR. Further, right ventricular dysfunction, pulmonary artery pressure, baseline mitral regurgitation, left ventricular ejection fraction, baseline atrial fibrillation, and age have no association with worsening TR post-device implantation. A substantial number of patients undergoing PPM or ICD implantation are at an increased risk of worsening TR. Importantly, in this largest review to date incorporating more than 66,000 subjects, worsening TR significantly increases mortality by greater than 140%, accordingly deserving more recognition and clinical attention in the current era.

Does Patient Compliance Influence Wearable Cardioverter Defibrillator Effectiveness? A Single-Center Experience.

The study was designed to assess patient adherence to wearable cardioverter defibrillator as an indicator of device effectiveness. The patient training is not widely properly standardized. We enrolled 25 patients with a wearable cardioverter defibrillator to prevent sudden cardiac death between June 2020 and August 2022. Among them, 84% were male with a median age of 63.6 years. The indication was an ischemic (44%) and a non-ischemic (56%) disease. The patients were followed-up until the decision to upgrade to an implantable device was taken. We trained the patients according to our suggested protocol. The median wear time was 90 days, and the median daily wear time was 23.5 h, similar throughout sex, age, and indication groups. In total, 24% of the participants underwent cardioverter defibrillator implantation. Between the device-implanted and non-implanted groups, left ventricular ejection fraction and left ventricular indexed end-diastolic volume were significantly different (EF 35.8 ± 12 vs. 46.4 ± 8.5%, p = 0.028, iEDV 108 ± 52 vs. 70.7 ± 21.1 mL/m2, p = 0.024). We did not find any differences in cardiac magnetic resonance data, even though all patients who underwent device implantation had late gadolinium enhancement spots. Our results support standardized patient training to obtain great patient adherence to the instructions to the wearable device and therefore its effectiveness.

P438 DIABETES MELLITUS AND HEART FAILURE: A DANGEROUS ASSOCIATION

Abstract Introduction Diabetes mellitus is a frequent co–morbidity in heart failure patients reaching a prevalence of about 35% and patients with diabetes mellitus are twice as likely as non–diabetics to develop heart failure. The presence of diabetes is associated with higher rates of cardiovascular morbidity and mortality. In recent years, the introduction of remote monitoring systems has allowed for more careful management of them, although there are no large studies demonstrating their effectiveness in terms of improving prognosis. The aim of our study was to evaluate the prognosis of patients with diabetes mellitus and heart failure undergoing remote monitoring. Methods All patients undergoing device implantation for heart failure in our Center were recruited into the study, and the incidence of events (new hospitalizations or hospitalizations) during the period from January 1, 2021 to December 31, 2021 was assessed. Patients were monitored, and direct telephone contact or contact with one of the family members was made for all of them. Data on clinical characteristics and drug therapy were recorded. Results A total of 240 patients (73±11 years, 81% male) of whom 74 were diabetic (73±11 years, 87% male) and 166 were nondiabetic (73±10 years, p=0.82, 80% male, p= 0.198) were enrolled in the study. The two groups had no statistically significant differences in terms of clinical characteristics (such as ejection fraction, NYHA class, presence of anemia, rate of wide QRS, or rate of defibrillator implantation) except for a higher incidence of coronary artery disease in diabetic patients (70%) and multivessel coronary disease (67%) than in non–diabetic patients (57% coronary artery disease p= 0.05, and 46% multivessel disease p= 0.02). There were no significant differences in terms of drugs with the exception of higher use of statins in the group of diabetic patients (84%) compared to non–diabetics (64%, p= 0.002). Diabetic patients had almost 4 times higher mortality rates than non–diabetic patients (22% and 6% respectively, p&amp;lt; 0.0001). Differently, hospitalization rates were not significantly different among diabetic patients (24%) compared with nondiabetic patients (28%, p= 0.58). Conclusions The association of diabetes mellitus and heart failure represents a dangerous combination associated with an increased incidence of death. Therefore, clinical monitoring strategies and intensity of drug therapy should be particularly implemented in diabetic patients.

Cardiac magnetic resonance findings and prognosis in type 1 myotonic dystrophy.

Cardiac involvement is a major determinant of prognosis in type 1 myotonic dystrophy (DM1), but limited information is available about myocardial remodeling and tissue changes. The aim of the study was to investigate cardiac magnetic resonance (CMR) findings and their prognostic significance in DM1. We retrospectively identified all DM1 patients referred from a neurology unit to our CMR laboratory from 2009 to 2020. Thirty-four patients were included (aged 45 ± 12, 62% male individuals) and compared with 68 age-matched and gender-matched healthy volunteers (43 male individuals, age 48 ± 15 years). At CMR, biventricular and biatrial volumes were significantly smaller (all P < 0.05), as was left ventricular mass (P < 0.001); left ventricular ejection fraction (LVEF) and right ventricular ejection fraction (RVEF) were significantly lower (all P < 0.01). Five (15%) patients had a LVEF less than 50% and four (12%) a RVEF less than 50%. Nine patients (26%) showed mid-wall late gadolinium enhancement (LGE; 5 ± 2% of LVM), and 14 (41%) fatty infiltration. Native T1 in the interventricular septum (1041 ± 53 ms) was higher than for healthy controls (1017 ± 28 ms) and approached the upper reference limit (1089 ms); the extracellular volume was slightly increased (33 ± 2%, reference <30%). Over 3.7 years (2.0-5.0), 6 (18%) patients died of extracardiac causes, 5 (15%) underwent device implantation; 5 of 21 (24%) developed repetitive ventricular ectopic beats (VEBs) on Holter monitoring. LGE mass was associated with the occurrence of repetitive VEBs (P = 0.002). Lower LV stroke volume (P = 0.017), lower RVEF (P = 0.016), a higher LVMi/LVEDVI ratio (P = 0.016), fatty infiltration (P = 0.04), and LGE extent (P < 0.001) were associated with death. DM1 patients display structural and functional cardiac abnormalities, with variable degrees of cardiac muscle hypotrophy, fibrosis, and fatty infiltration. Such changes, as evaluated by CMR, seem to be associated with the development of ventricular arrhythmias and a worse outcome.

A North American, single-center experience implanting fenestrated atrial devices and atrial flow regulators into a heterogeneous group of pediatric pulmonary hypertension patients.

The clinical deterioration commonly experienced by pediatric patients with pulmonary arterial hypertension (PAH) has motivated a shift in the treatment of pulmonary hypertension (PH) through innovations in surgical salvage interventions. The Occlutech fenestrated atrial septal defect (FASD) Occluder and the atrial flow regulator (AFR), which provides a protective, atrial-level shunt during hypertensive crises, have found an important role in treating pediatric patients with PAH. Other groups of pediatric patients with PH may also benefit from a similar protective physiology. The primary aim of this work is to present a single center's experience with AFR and FASD devices for managing a heterogeneous group of pediatric PH patients. A secondary goal is to identify hemodynamic changes and complications following device implantation. We performed a retrospective review of all pediatric PH patients who, after being found suitable, either successfully or unsuccessfully received an FASD or AFR device between January 2015 and December 2021 at the Stollery Children's Hospital in Edmonton, Canada. Fourteen patients (eight female) with a median age of 4.6 (range 0.3-17.9) years and a median body mass index of 15.1 (Q1 = 13.8, Q3 = 16.8) kg/m2 underwent device implantation: five received FASDs, eight received AFRs, and one was ultimately unable to receive an implant due to thrombosed iliac vessels and required surgical intervention. Of the fourteen patients, seven were in group 1 (PAH), one was in group 3 (lung disease), and six were in group 5 (primarily pulmonary hypertension vascular disease) under the World Symposium PH classification. All patients were on mono-, dual-, or triple-drug PH therapy. Device stabilization was not possible for two patients, who then required a repeat catheterization. Of the group 1 patients, three AFR and three FASD implants were successful, while one FASD implant was unsuccessful due to thrombosed vessels. At a six-month clinical assessment, all group 1 patients had patent devices and improved WHO FCs. This work presents a single center's experience with AFR and FASD implants in a heterogeneous group of fourteen pediatric patients with severe PH. This treatment strategy is novel in the pediatric population and so this work provides momentum for future studies of interventional cardiac catheterization procedures for pediatric patients with PH. Further collaborations are required to develop criteria to identify ideal pediatric candidates and optimally time interventions in order to maximize the benefits of this treatment.

Delayed versus primary sternal closure for left ventricular assist device implantation: Impact on mechanical circulatory support infections

Delayed sternal closure may be required after left ventricular assist device (LVAD) implantation due to coagulopathy or hemodynamic instability. There is conflicting data regarding infection risk. We performed a single-center, retrospective analysis of patients who received their first LVAD between May 2012 and January 2021. Patients were divided into delayed sternal closure (DSC) and primary sternal closure (PSC) groups. We used chi-squared or Fisher Exact tests, as appropriate, to compare the incidence of postoperative LVAD-related infections (mediastinal/sternal wound) and LVAD-specific infections (driveline and pump pocket) after definitive chest closure between these two groups. A total of 327 patients met eligibility criteria, including 127 (39%) patients that underwent DSC and 200 (61%) patients that had a PSC. Demographic and clinical characteristics were similar except for an overrepresentation of men (87% vs. 75%, p=.016), Interagency Registry of Mechanically Assisted Circulatory Support class I-II patients (89% vs 66%, p < .001), patients with a previous sternotomy (43% vs 13%, p < .001), and patients with chronic kidney disease (55% vs 43%, p=.030) in the DSC group. The median DSC time was 24 (IQR: 24-48) hours. The incidence of LVAD-related mediastinal/sternal wound infection was similar between the DSC and PSC groups (4.7% vs 3.0%, p=.419). There was no difference between DSC and PSC groups in the incidence of driveline infection (6.3% vs 9%, p=.411) and pump pocket infection (1.6% vs 1.5%, p =.901), respectively. DSC does not seem to increase the incidence of LVAD-related or LVAD-specific infection rates in heart failure patients undergoing device implantation surgery.

A survey of the implementation rate of cardiac rehabilitation for patients with heart disease undergoing device implantation in Japan.

The effect of cardiac rehabilitation (CR) on patients undergoing device implantation (DI) for arrhythmias has been reported; however, the implementation status of these patients has not been clarified. This study aimed to verify the implementation status of CR for patients with heart disease who have undergone DI using real-world data. This was an observational study using a nationwide administrative database associated with the diagnosis procedure combination (DPC) system in Japan (2014-2018). Subjects were patients with heart disease (70 667 cases) who underwent DI during the above scheduled hospitalization period. The overall rate of CR and the background factors of the subjects were verified. The CR rate for patients with heart disease who underwent DI during hospitalization was 23%, and the CR rate for patients with comorbid heart failure who underwent DI was only 32%. It was confirmed that progressing age was associated with a higher CR implementation rate. The lower the Barthel index score at the time of admission, the higher the CR implementation rate. CR was performed for only one-quarter of all the patients during admission for DI and just one-third of the patients for DI with heart failure. Most of these patients were elderly and had a decreased ability to perform activities of daily living. The DPC data are subject to various limitations, and further research is necessary.

Endovascular Baroreflex Amplification With the MobiusHD Device in Patients With Heart Failure and Reduced Ejection Fraction: Interim Analysis of the First-in-Human Results

BackgroundEndovascular baroreflex amplification with the MobiusHD, a self-expanding stent-like device that is implanted in the internal carotid artery, was designed to reduce the sympathetic overactivity that contributes to progressive heart failure with reduced ejection fraction. MethodsSymptomatic patients (New York Heart Association class III) with heart failure with reduced ejection fraction (left ventricular ejection fraction [LVEF] ≤40%) despite guideline directed medical therapy and n-terminal pro-B type natriuretic peptide (NT-proBNP) levels ≥400 pg/mL in whom carotid ultrasound and computed tomographic angiography demonstrated absence of carotid plaque were enrolled. Baseline and follow-up measures included 6-minute walk distance (6MWD), Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ OSS), and repeat biomarkers and transthoracic echocardiography. ResultsTwenty-nine patients underwent device implantation. The mean age was 60.6 ± 11.4 years, and all had New York Heart Association class III symptoms. Mean KCCQ OSS was 41.4 ± 12.7, mean 6MWD was 216.0 ± 43.7 m, median NT-proBNP was 1005.9 pg/mL (894, 1294), and mean LVEF was 34.7 ± 2.9%. All device implantations were successful. Two patients died (161 days and 195 days) and one stroke occurred (170 days) during follow-up. For the 17 patients with 12-month follow-up, mean KCCQ OSS improved by 17.4 ± 9.1 points, mean 6MWD increased by 97.6 ± 51.1 meters, a mean 28.4% reduction from the baseline NT-proBNP concentration was found, and mean LVEF improved by 5.6% ± 2.9 (paired data). ConclusionEndovascular baroreflex amplification with the MobiusHD device was safe and effected positive changes in quality of life, exercise capacity, and LVEF, consistent with observed reductions in NT-proBNP levels.

Transvenous Phrenic Nerve Stimulation for Central Sleep Apnea

RespiCardia remedē System (Minnetonka, MN 2017), a transvenous phrenic nerve stimulator, is indicated to treat central sleep apnea (CSA) by stimulating the phrenic nerve to cause diaphragmatic contraction to restore normal breathing during sleep. CSA is associated with decreased patient quality of life and worsens cardiovascular outcomes. Systematic review was conducted according to the Preferred Reporting of Systematic Reviews and Meta-Analysis guidelines. PubMed/MEDLINE, Cochrane, EBSCO CINAHL, and Ovid databases were queried by 2 independent reviewers for English-language studies published between 2000 and 2021. The initial search screened for all occurrences of "remedē" then was further refined to include studies evaluating use of the RespiCardia remedē System as a treatment for CSA in multiple patients. A total of 124 articles were identified from the initial search results. A total of 37 articles were identified through screening of title and abstracts from initial results. Full-text review of all the articles was then completed. Of the 13 articles included, a total of 232 patients underwent device implantation. We sought to summarize the available evidence regarding patient selection for implantation, immediate and delayed complications, adherence to therapy, and polysomnographic evidence of efficacy. All 13 articles detailed significant decreases in central apnea index and many patients reported significant mild to marked improvement in quality of life. In conclusion, the remedē System has been demonstrated to improve sleep and respiratory parameters, with few complications. This device demonstrates safe and effective treatment of moderate to severe CSA in adult patients, including those with heart failure.

Diagnosis and treatment of the rare procedural complication of malpositioned pacing leads in the left heart: a single center experience

Objectives. This study assessed the management approach and outcome of the pacemaker or implantable cardioverter-defibrillator (ICD) leads malpositioned in the left heart. Malpositioned leads (MPLs) may have deleterious consequences, and appropriate management remains uncertain. Methods. The study population included all patients referred to a single institution for MPL in the left side of the heart after pacemaker or ICD implantation during the period from 2015 to 2021. The approach and outcome of lead management were retrospectively assessed. Results. During the study period, 6887 patients underwent device implantation. MPL was diagnosed in five patients (0.07%). In four cases, the pacing lead was placed in a coronary sinus (CS) branch, while the pacing lead was inside the left ventricle (LV) in one case. Symptoms suggestive of lead malposition were reported by 2 patients (40%). One of the patients presented with recurrent TIAs. Another presented with inappropriate ICD shocks. In one asymptomatic case, an ICD lead changed position from the right ventricle to the CS, suggesting idiopathic lead migration. In 4/5 patients, the leads were removed or repositioned by percutaneous approach, with no major periprocedural complications. Conclusions. In this series of MPL in the left heart, two patients presented with thromboembolic events or inappropriate ICD shocks. These serious complications highlight the critical need for early correct diagnosis and proper management of MPL.

Usability, performance and safety of a new device for degenerative mitral regurgitation: in vivo chronic evaluation.

OBJECTIVESThis study aimed to evaluate the usability, performance and safety of an innovative mitral valve device in the chronic setting characterized by an intraventricular bridge, which enables artificial chordae anchoring and/or direct posterior leaflet fixation.METHODSTen female sheep were employed and underwent device implantation. Any interference of the device with leaflet motion, ease of device use, correct chordae length estimation and implantation were evaluated. Post-procedural valve competence and device performance were verified by periodic postoperative echocardiograms and laboratory examinations. Following euthanasia, gross anatomy and histology evaluation of the hearts and valves were performed to detect tissue abnormalities and inflammation reaction related to the device.RESULTSThe procedure was successfully completed in all 10 sheep. Lengths of the 2 chordae implanted were 23 (21.5–24) mm and 23 (22.5–24) mm. The time required to suture both pairs of the artificial chordae was 2.7 ± 0.7 min. At the 3-month follow-up, left ventricular function was normal. The transvalvular peak pressure gradient was 9 (7.5–10) and the mean gradient was 4 (3.5–4) mmHg. Upon necropsy and histological evaluation, no damage to left ventricle wall, valve leaflets, chordae and papillary muscles and absence of thrombus formation and inflammatory reaction were observed. Radiological images showed neither fracture of the device nor calcifications. Laboratory tests showed no signs of haemolysis.CONCLUSIONSIn vivo late tests confirmed the ease of correct chordal length estimation prior to implantation, short operative time and usability in flailed anterior leaflet repair. The absence of negative impact of the device on mitral leaflets motion, function and structure and successful repair might suggest that the device would be useful in complex degenerative mitral disease.

Therapeutic benefits of distal ventricular pacing in mid-cavity obstructive hypertrophic cardiomyopathy

Introduction:Hypertrophic cardiomyopathy (HCM) patients with left ventricular (LV) mid-cavity obstruction (LVMCO) often experience severe drug-refractory symptoms thought to be related to intraventricular obstruction. We tested whether ventricular pacing, guided by invasive haemodynamic assessment, reduced LVMCO and improved refractory symptoms.Methods:Between December 2008 and December 2017, 16 HCM patients with severe refractory symptoms and LVMCO underwent device implantation with haemodynamic pacing study to assess the effect on invasively defined LVMCO gradients. The effect on the gradient of atrioventricular (AV) synchronous pacing from sites including right ventricular (RV) apex and middle cardiac vein (MCV) was retrospectively assessed.Results:Invasive haemodynamic data were available in 14 of 16 patients. Mean pre-treatment intracavitary gradient was 77 ± 22 mmHg (in sinus rhythm) versus 21 ± 21 mmHg during pacing from optimal ventricular site (95% CI: −70.86 to −40.57, p < 0.0001). Optimal pacing site was distal MCV in 12/16 (86%), RV apex in 1/16 and via epicardial LV lead in 1/16. Pre-pacing Doppler-derived gradients were significantly higher than at follow-up (47 ± 15 versus 24 ± 16 mmHg, 95% CI: −37.19 to −13.73, p < 0.001). Median baseline NYHA class was 3, which had improved by ⩾1 NYHA class in 13 of 16 patients at 1-year post-procedure (p < 0.001). The mean follow-up duration was 4.6 ± 2.7 years with the following outcomes: 8/16 (50%) had continued symptomatic improvement, 4/16 had symptomatic decline and 4/16 died. Contributors to symptomatic decline included chronic atrial fibrillation (AF) (n = 5), phrenic nerve stimulation (n = 3) and ventricular ectopy (n = 1).Conclusion:In drug-refractory symptomatic LVMCO, distal ventricular pacing can reduce intracavitary obstruction and may provide long-term symptomatic relief in patients with limited treatment options. A haemodynamic pacing study is an effective strategy for identifying optimal pacing site and configuration.

31 Cardiac magnetic resonance findings in patients with Type 1 myotonic dystrophy

Abstract Aims Heart disease is a major determinant of prognosis in type 1 myotonic dystrophy (DM1), second only to respiratory complications. Cardiac imaging, possibly including cardiac magnetic resonance (CMR), is recommended in patients with DM1. However, limited information is available on CMR findings and their prognostic significance in DM1. Methods and results We identified all patients with DM1 evaluated from 2009 to 2020 in a CMR laboratory with an established collaboration with a Neuromuscular Disorder Unit. Thirty-four patients were retrieved (21 males, aged 45 ± 12). By the time of CMR examination, 90% had neuromuscular symptoms (mean duration 17 ± 13 years), 13 (38%) had previous reports of atrioventricular block (n = 12 1st degree, n = 1 2nd degree type 1), 30 (88%) of intraventricular conduction disturbances (n = 5 left bundle branch block, n = 5 right bundle branch block, n = 3 left anterior fascicular block, n = 17 other non-specific or incomplete intraventricular conduction delay), 4 (12%) of atrial fibrillation or flutter. No patient had a device. At CMR, 5 (15%) patients had left ventricular (LV) systolic dysfunction [LV ejection fraction (LVEF) &amp;lt;50%] and 4 (12%) a depressed right ventricular (RV) function (RVEF &amp;lt;50%). Compared to age- and sex-specific reference values for our laboratory (Figure 1 left), 12 (35%) patients showed a decreased LV end-diastolic volume index (LVEDVi), 7 (21%) a decreased LV mass index (LVMi), and 29 (85%) a decreased LVMi/LVEDVi ratio. Nine (26%) patients had mid-wall late gadolinium enhancement (LGE, mean extent 4.5 ± 2.0% of LVM; n = 8 septal, n = 4 inferolateral, n = 2 inferior, n = 1 anterolateral, see Figure 1 middle), and 14 (41%) some areas of fatty infiltration (n = 9 involving the LV, n = 13 the RV). Native T1 in the interventricular septum (1,041 ± 53 ms) approached the upper reference limit (1089 ms), and the extracellular volume was slightly increased (33 ± 2%, reference values &amp;lt;30%). Over a median follow-up of 2.5 years (interquartile interval: 1.5–4.0), 2 (6%) patients died for infectious and respiratory complications, 5 (15%) underwent device implantation (n = 4 PM; n = 1 ICD), and 4 (12%) had a documentation of high-risk (Lown class ≥4) ventricular ectopic beats (VEBs). Among all CMR variables collected, higher values of LVMi/LVEDVi ratio emerged as univariate predictor of all-cause death (P = 0.044). At logistic regression analysis, anteroseptal wall thickness was associated with the need for device implantation (P = 0.028), while LGE mass was associated with high-risk VEBs (P = 0.026) (Figure 1 right). Conclusions Patients with DM1 display several structural and functional cardiac abnormalities, with variable degrees of cardiac muscle hypotrophy, fibrosis, and fatty infiltration. The possibility to predict the need for device implantation, ventricular arrhythmias, and all-cause or cardiovascular mortality should be verified in larger cohorts.