Trends of blood pressure, raised blood pressure, hypertension and its control among Italian adults: CUORE Project cross-sectional health examination surveys 1998/2008/2018

Objectives
To assess in the Italian general adult population the trends of blood pressure (BP) and prevalence of raised BP (RBP), hypertension and its control in order to evaluate population health and care, and the achievement of an RBP 25% relative reduction as recommended by the WHO at population level.

Design
Results comparison of health examination surveys, cross-sectional observational studies based on health examination of randomly selected age and sex stratified samples including residents aged 35–74 years. Data of the 2018/2019 survey were compared with the previous ones collected in 1998/2002 and 2008/2012.

Setting
Health examination surveys conducted in Italy within the CUORE Project following standardised methodologies.

Participants
2985 men and 2955 women examined in 1998/2002, 2218 men and 2204 women examined in 2008/2012 and 1031 men and 1066 women examined in 2018/2019.

Primary and secondary outcome measures
Age-standardised mean of BP, prevalence of RBP (systolic BP and/or diastolic BP ≥140/90 mm Hg), hypertension (presenting or being treated for RBP) and its awareness and control, according to sex, age class and educational level.

Results
In 2018/2019, a significant reduction was observed in systolic BP and diastolic BP in men (1998/2002: 136/86 mm Hg; 2008/2012: 132/84 mm Hg; and 2018/2019: 132/78 mm Hg) and women (132/82 mm Hg, 126/78 mm Hg and 122/73 mm Hg), and in the prevalence of RBP (50%, 40% and 30% in men and 39%, 25% and 16% in women) and of hypertension (54%, 49% and 44% in men and 45%, 35% and 32% in women). Trends were consistent by age and education attainment. In 2018/2019, hypertensive men and women with controlled BP were only 27% and 41%, but a significant favourable trend was observed.

Conclusions
Data from 2018/2019 underlined that RBP is still commonly observed in the Italian population aged 35–74 years, however, the WHO RBP target at that time may be considered met.

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Novembre 2022

Abstract 14531: Intracardiac versus Transvenous Pacemaker Implantation: Impact on Clinical Outcomes and Healthcare Utilization

Circulation, Volume 146, Issue Suppl_1, Page A14531-A14531, November 8, 2022. Introduction:Permanent pacemakers are frequently used to treat disorders of cardiac rhythms. Recently, intracardiac (leadless) pacemakers offer potential treatment with an alternative insertion procedure due to their novel design. Literature comparing hospitalization outcomes between the devices is scarce. We aim to assess the impact of intracardiac pacemakers on readmissions and hospitalization trends.Methods:We analyzed the National Readmissions Database (NRD) from 2016 to 2019 seeking patients admitted for sick sinus syndrome, second-degree or third-degree AV block who received either a transvenous pacemaker or an intracardiac pacemaker. Patients were stratified by device type and assessed for 30-day readmissions, inpatient mortality, and length of stay. Descriptive statistics, Cox proportional hazards and multivariate regressions were used to compare the groups.Results:During the studied period, 21,782 patients met the inclusion criteria. Transvenous pacemakers were implanted in 17,677 patients and intracardiac pacemakers implanted in 4,017 patients. The mean age was 81.07 years, and 45.52% were female. No statistical difference was noted for readmissions (HR 1.14, 95% CI 0.92 – 1.41, p = 0.225) and inpatient mortality (HR 1.36, 95% CI 0.71 – 2.62, p = 0.352) between transvenous and intracardiac groups. Kaplan-Meier curves for readmission and mortality are presented in Figure 1A and 1B, respectively. Multivariate linear regression revealed that length of stay was 0.54 (95% CI 0.26 – 0.83, p < 0.001) days longer for intracardiac group.Conclusion:Hospitalization outcomes associated with intracardiac pacemakers are comparable to traditional transvenous pacemakers. Patients may benefit from the use of this new device without incurring additional resource utilization. Further studies are needed to compare long term outcomes between transvenous and intracardiac pacemakers.

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Ottobre 2022

Abstract 15819: Longing for a Pacemaker, Association of Prolonged Qrs and Permanent Pacemaker in the Tavr Population

Circulation, Volume 146, Issue Suppl_1, Page A15819-A15819, November 8, 2022. Background:The duration of the QRS carries valuable information regarding structural disease, conduction defects, or even ischemia. Studies have shown that a widened QRS ( >120) is associated with poor cardiovascular outcomes. In this study we investigated the impact of the presence of a widened QRS (wQRS )previous to Transcatheter Aortic Valve Replacement (TAVR) and clinical outcomes.Methods::Retrospective analysis of electronic medical records from 2018-2020 at the University of Illinois Chicago identified TAVR patients. Patients were placed into two groups: a wQRS and a nQRS group. Those with pacemakers prior to procedure were excluded. Primary outcomes included PPM placement prior to discharge, composite MACE (all-cause mortality, MI, or CVA), and (LOS) at 6 and 12 months.Results:We included 149 patients in this analysis. There were 76.1% male, 57.1% non-white, and 74 ± 13 years old on average. A wQRS was found in 46 (30.9%) and 103 (69.1%) were found to have a nQRS. Of this group, 40.2% had a history of congestive heart failure (CHF). The average ejection fraction (EF) was 50% with 80% of patients having a normal (EF). The CoreValve was placed in 65.7% of patient compared to 34.3% of patients having the Sapian valve placed. There were no differences in age, sex, or race between the two groups. Of all patient’s in the study, those with a wQRS were more likely to have a PPM placed prior to discharge compared to those with nQRS (17.4% (8) vs 5.8% (6) , p=0.025). Though not significant, 14% (13)of patients with the CoreValve placed required PPM prior to discharge compared to 2.5%(1) in the Sapian valve group (p=.175). There was no statistically significant difference in composite MACE, LOS, or significant bleeding events in either groups at 6 or 12 months.Conclusion:Our results suggest that patients with a wQRS are more likely to receive a PPM placement post TAVR during index hospitalization compared to those with a nQRS. This study suggests further investigation into the predictive nature of EKG parameters on clinical outcomes be done.

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Ottobre 2022

Abstract 15725: Non Existing Pacemaker: A Complication of Kyphoplasty

Circulation, Volume 146, Issue Suppl_1, Page A15725-A15725, November 8, 2022. Introduction:Diagnosis of cement emboli remains challenging due to heterogenicity of diagnostic findings. We describe a case of cement embolism interpreted as abandoned pacemaker leads.Case description:A 76-year-old female underwent lumbar kyphoplasty. In the post-anesthesia care unit, she developed multiple asymptomatic episodes of non-sustained ventricular tachycardia. Her lab work including basic metabolic panel, electrolytes, and troponin was unremarkable. A transthoracic echocardiogram (TTE) revealed intracardiac foreign body interpreted as abandoned pacemaker wires originating at the superior vena cava with one terminating in the right ventricular (RV) apex and the other in the right atrial (RA) appendage (Figure 1). Chest computer tomography (CT) confirmed intracardiac pacemaker wires. The patient denied any history of pacemaker placement. TTE and CT images were reviewed again with multiple other opinions stating that the foreign body represented dense cement from the vertebral body. It exited through a paravertebral vein into the inferior vena cava making its way to the right heart (Figure 2). Coronary angiography confirmed an elongated cement embolus. The patient underwent cement removal through sternotomy.Conclusions:Diagnosis of cement embolism may remain challenging as it can mimic any foreign bodies including pacemaker wires. Suspicion for the diagnosis should remain high in any patient who underwent kyphoplasty and developed cardiac arrhythmias or other cardiac symptoms.Image 1.A – Pacemaker lead passing through RA to the RV.Image 2.A- cement material in the right heart. B- Cement extravasating through right paravertebral vein.

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Ottobre 2022

Abstract 13109: Pacemaker Mediated Contact Allergy to Thiuram and Paraphenylenediamine

Circulation, Volume 146, Issue Suppl_1, Page A13109-A13109, November 8, 2022. Introduction:Allergic contact dermatitis to cardiac rhythm devices (CRD) has been reported sporadically from the early 1980s to present. Most of these cases involve allergic reactions to direct contact agents such as nickel, silicone, titanium, cobalt, epoxy resin, mercury, polysulfone, polyurethane and polychloroparaxylene. Our case is unique in that the strongest allergic reaction was with thiuram and P-phenylenediamine (PPD), which has only been documented once since the advent of permanent pacemakers (PPM)Case:58-year old male with history of hypertension and coronary artery disease presented with palpitations and fatigue. Holter monitoring demonstrated tachybrady syndrome and he underwent dual chamber PPM implantation (L331 AccoladeTMMRI – Boston Scientific Inc). Eight weeks later he presented with new onset rash around his neck and the surgical site. PPM allergy was suspected, as patient did not respond to empiric antibiotics. He underwent PPM and lead extraction. Decision was made to observe patient without immediate re-implantation of PPM. Skin patch testing was strongly positive to thiuram and PPD. Final diagnosis of allergic contact dermatitis was made and patient’s condition improved.Discussion:Thiuram and PPD, the raw materials used in the production of silicone rubber, encase pacemaker headers and leads. Individuals typically get sensitized to PPD by using hair dyes or temporary henna tattooing. The device used in our patient contained the same compounds. No studies to date document the true incidence and/or prevalence of allergic reactions to pacemaker components. One non-randomized retrospective trial reported benefits of skin patch testing before CRD implantation in patients who had a history of allergy to metals. Future trials are warranted to further evaluate the efficacy and benefits of pre-implantation skin testing and if it would benefit the population as a whole.

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Ottobre 2022

Abstract 10052: Leadless Pacemaker and Deep Brain Stimulator: Proximity Without Interference

Circulation, Volume 146, Issue Suppl_1, Page A10052-A10052, November 8, 2022. Introduction:Deep Brain Stimulator (DBS) treatment is a known form of treatment for advanced Parkinson’s disease refractory to medical therapy. With the current aging population, instances where cardiac implantable electronic devices are becoming more frequent. Due to risk of complications from implantation of both devices, literature has recommended keeping a minimum distance of 20cm (or 6in) between the two generators. In this case we have demonstrated a successful leadless pacemaker placement at 37mm apart without any complications.Case Report:75 year old female with past medical history of essential tremor status post left VIM and VOA/VOP deep brain stimulator placement in 2019 presented to the emergency department with chief complaint of fall secondary to weakness. Electrocardiogram demonstrated Afib with RVR. Heparin was started for anticoagulation as the patient’s CHADSVASC score was noted to be 5. Rate control was unsuccessful despite attempts with Metoprolol, digoxin loading, and max use of intravenous Cardizem. Cardioversion was not an option as the patient would need to commit to 4 weeks of uninterrupted therapeutic anticoagulation and be unable to undergo lung biopsy for new found lung mass. Extensive discussion was held with the patient and it was determined to proceed with AV nodal ablation with leadless pacemaker placement. Patient underwent successful placement of the Medtronic MC1VR01 US leadless pacemaker 37mm apart from the prior DBS device. Patient’s heart rate after the procedure remained stable at the lower rate of 80bpm with follow up device check in clinic showing no complications or interference among devices.

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Ottobre 2022

Abstract 14480: Importance of the Characteristics of Aortic Valve Calcification for Identifying Patients at a High Risk for Permanent Pacemaker Implantation After Different Types of Transcatheter Aortic Valve Replacement

Circulation, Volume 146, Issue Suppl_1, Page A14480-A14480, November 8, 2022. Background:Aortic valve calcification is a known risk factor for permanent pacemaker implantation (PPMI) following transcatheter aortic valve replacement (TAVR). However, the impact of characteristics of the calcium deposit on the aortic valve and annulus on post-TAVR PPMI has not been well defined.Hypothesis:Analysis of the characteristics of aortic valve calcification and its interactions with different types of TAVR could identify patients at a high risk for PPMI.Methods:This single-center retrospective study included 352 patients treated with TAVR for severe symptomatic aortic stenosis. One hundred ninety-three patients received self-expanding (SE) valves and 159 patients received balloon-expandable (BE) valves. Aortic valve calcification was evaluated using multi-slice computed tomography (MSCT) and 3mensio™ software prior to the TAVR. Total calcium volume (TCV) in the aortic valve was measured in the space ±10 mm of the aortic annulus. In addition, the largest calcium nodule diameter (LCND) was measured at the non-coronary cusp – right coronary cusp commissure, which is anatomically adjacent to the His bundle. TCV and LCND were compared among patients who required PPMI vs. those who did not.Results:PPMI was required post-TAVR in 69 subjects (25.9% in SE and 11.9% in BE, p10mm (Figure). There was no significant association between either TCV or LCND and PPMI in BE TAVR.Conclusions:PPMI was more common in SE than in BE. The size of LCND was associated an increased risk for SE. The preprocedural assessment of LCND may help the selection of appropriate types of TAVR (SE vs. BE) to reduce the risk for PPMI.

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Ottobre 2022

Abstract 13416: Evaluation of Risk Factors for Pacemaker After Tavr Among Patients With a Pre-Existing Right Bundle Branch Block

Circulation, Volume 146, Issue Suppl_1, Page A13416-A13416, November 8, 2022. Background:Pacemaker implantation (PMI) remains a common complication after TAVR. While a pre-existing right bundle branch block (RBBB) is consistently the strongest reported risk factor for PMI, most patients with a RBBB will not require PMI after TAVR.Objective:To identify factors associated with a higher risk of PMI after TAVR among patients with pre-existing RBBB.Methods:We identified all patients at a single institution undergoing first-time TAVR with a balloon-expandable prosthesis without a pre-existing pacemaker or ICD, and pre-existing RBBB (defined as RBBB morphology with QRS >=110ms) from December 2013 to December 2020 (n=219). We evaluated the univariate association for numerous clinical, EKG, imaging, and procedural characteristics with PMI. We included all factors with p=16% were associated with PMI on univariate analysis. When included in a logistic regression model, syncope (OR 3.2, 95%CI: 1.1-8.8, p=0.027) and oversizing (OR 3.1, 95% CI: 1.4-6.8, p=0.005) remained independently associated with PMI. These findings were consistent in the bootstrapped samples. Those with both factors (n=4) had a PMI rate of 75% which was higher compared to those with one or neither (43% and 22%, respectively; p16% were independently associated with a higher risk of PMI. These findings warrant external validation.

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Ottobre 2022

Abstract 11583: Impact of Micra Pacemaker Implantation on Echocardiographic Parameters: A Multi-Center Analysis

Circulation, Volume 146, Issue Suppl_1, Page A11583-A11583, November 8, 2022. Introduction:Studies on leadless pacemakers (LP) are very limited and they often fail to reflect real population outcomes.Hypothesis:We sought to evaluate the effect of leadless pacemaker implantation on the echocardiographic parameters including ventricular function and valvular competence.Methods:A retrospective review including 162 patients (81 Micra Leadless pacemaker implant and 81 dual-chamber transvenous pacemakers) from 3 centers were included. Follow-up clinical, echocardiographic, and pacing characteristics were obtained over a median of 14+/-2 months.Results:baseline demographics and clinical characteristics were comparable between the 2 groups including age (78.6+/-9.9, Range 35-95) and gender (49 males, 69.5%). Compared to conventional pacemakers, LP patients had worsening tricuspid regurgitation noted on follow-up echo in 59.3% of patients compared to baseline(P

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Ottobre 2022

Abstract 12834: Hospital Variation in Implantation of Permanent Pacemaker After Transcatheter Aortic Valve Implantation: An Insight From the US Nationwide Readmission Database

Circulation, Volume 146, Issue Suppl_1, Page A12834-A12834, November 8, 2022. Background:Pacemaker implantation (PPM) remains the most common complication after TAVI. However, the relationship between hospital volume of TAVI discharge and PPM implantation remains unknown.Methods and Results:The purpose of this study was to evaluate the association between annual TAVI discharge volumes with 30-day incidence of PPM implantation. We utilized the most recent available 2018 US Nationwide Readmission Database. International Classification of Diseases ICD-10 codes were used to identify all hospitalizations. We categorized hospitals performing 200 high-volume facilities. A total of 34,740 non-weighted TAVI hospitalizations were included in this analysis. Of the included cases, 37.5% (13,024) were performed in low volume centers, whereas 31.3% (10,862) and 31.2% (10,854) cases were performed in medium and high-volume centers. The overall 30-day rate of PPM Implantations was 19.5% (6,771). On adjusted analysis there was no difference between high (OR 1.01, 95% CI 0.95-1.08) and medium volume (OR 1.02, 95% CI 0.95-1.09) centers when compared to low volume centers respectively. Moreover, cumulative incidence curves showed similar rates of readmission for PPM implantations (Figure 1: P log rank 0.20).Conclusions:PPM implantation rates remain high post TAVI. Higher volume of TAVI discharge does not result in fewer PPM implantations. Further studies and interventions are required to reduce PPM implantation after TAVI.

Leggi
Ottobre 2022

Abstract 12053: Worsening Tricuspid Regurgitation After Leadless Pacemaker Implantation Leads to Higher Hospitalization for Heart Failure

Circulation, Volume 146, Issue Suppl_1, Page A12053-A12053, November 8, 2022. Introduction:One of the many purported benefits of a leadless pacemaker (LP) is avoidance of interaction with the tricuspid valve, decreasing tricuspid valve dysfunction from chronic injury resulting from contact with transvenous leads. Data suggests that 31-38% of patients develop worsening tricuspid regurgitation (TR) after transvenous pacemaker implantation. However, some recent data suggest that LP therapy is also associated with a higher incidence of worsening TR, possibly similar to transvenous pacemakers. We present data from a large community-based health system on the incidence of worsening TR after LP implantation and its clinical implications.Methods:A total of 256 patients (mean age 80±10 years, 61% male) who received Micra leadless single chamber pacemaker devices at the NorthShore University HealthSystem between April 2017 and November 2021 were retrospectively reviewed. A total of 103 patients (40%) received both a transthoracic echocardiogram within 6 months pre-implantation and 6 months post-implantation. Characterization of TR and heart failure hospitalization were gathered through chart review.Results:Of the 103 patients, 39 (38%) were found to have worsening of their TR after LP implantation when compared to before. Of the patients with worsening TR, 18 (46%) required hospitalization for heart failure within 12 months, compared to 15 (23%) without worsening TR (X2= 5.7,p= 0.02).Conclusions:LP implantation is associated with comparable levels of worsening TR (38%) when compared to transvenous pacemakers. Worsening TR is associated with increased heart failure hospitalization within 12 months. More data is required to establish the reasoning behind the comparable levels of worsening TR in LP given the lack of mechanical interaction with the tricuspid valve apparatus.

Leggi
Ottobre 2022

Abstract 13296: The Internal Jugular Vein for Leadless Pacemaker Implantation in Patients Under 30 Kg

Circulation, Volume 146, Issue Suppl_1, Page A13296-A13296, November 8, 2022. Pacemaker placement in pediatrics involves consideration for potential complications with leads, pocket erosion and infection. Pacemaker generators also carry their own complications such as hematoma formation and additional infection. This is why a reliable leadless pacemaker implantation technique is desired. In this dual center, single operator, retrospective study we demonstrate the feasibility of leadless pacemaker implantation via internal jugular vein in patients under 30 kg. This technique does not require surgical cut-down and preserves the patency of the involved vessels. Procedures were conducted by an electrophysiologist at the University of Minnesota and UC Davis Medical Center and University of Minnesota Medical Center from 2018-2021 with the Micra (Medtronic, Minneapolis, MN, USA). Vascular access in the largest diameter internal jugular vein was obtained in the right or left internal jugular veins via the Seldinger technique with serial dilation from 5 or 8 French size to 27 French. Results showed that in eight patients under 30kg, leadless pacemaker can implanted via the internal jugular vein with no need for surgical cut down due to having good short-term and mid-term vein patency. Seven out of eight patients were discharged the next day after the procedure. No venous complications related to access were noted. All patients met an indication for pacemaker implantation with ventricular-only pacing needed or had prophylactic leadless pacemaker placed or was the patient and cardiology team preference after multi-disciplinary discussion. We recommend echocardiographic guidance to minimize perforation risk.

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Ottobre 2022

Abstract 11555: Risk Factors Associated With Pacemaker Implant Following Hospital Discharge, Within 30 Days of TAVR

Circulation, Volume 146, Issue Suppl_1, Page A11555-A11555, November 8, 2022. Introduction:Delayed conduction abnormalities can occur after transcatheter aortic valve replacement (TAVR) in a small but significant group of patients and may be associated with out-of-hospital adverse events including syncope and need for urgent permanent pacemaker (PPM) implantation. There are limited data on the factors associated with need for PPM implantation following TAVR hospital discharge.Methods:A single-center retrospective analysis of TAVR patients (2011-2019) was performed. Exclusion criteria included presence of a PPM prior to TAVR, PPM implant during index admission for TAVR, and absence of pre-TAVR ECG data. The primary endpoint was PPM implantation occurring after hospital discharge, within 30 days of TAVR (late PPM).Results:Of 1148 TAVR procedures performed during the study period, 850 (79.7 ± 9.3 years old, 53.8% male) were included in analysis. There were 16 patients (1.88%) who required late PPM implantation. The median duration of time between discharge and late PPM was 4 (2.8-9.3) days. Univariate analysis revealed that pre-existing right bundle branch block, and change in PR interval from pre-TAVR through day of discharge was associated with late PPM (Figure). Notably, new left bundle branch block was not associated with late PPM. Multivariate analysis demonstrated that change in PR interval from pre-TAVR through day of discharge was independently associated with late PPM. The rate of late PPM increased linearly with greater PR prolongation (y=1.10x-1.01, r2=0.93), and patients with PR increase >20ms had a 4.8% rate of late PPM implantation (Figure).Conclusions:PR prolongation through day of discharge independently predicted need for late PPM following TAVR in our single center experience. Patients with PR increase >20ms from baseline are at particularly high risk for late PPM and should be counseled about the potential need for future PPM.

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Ottobre 2022

Abstract 10305: A Bioresorbable Pacemaker With Transient Closed-Loop System

Circulation, Volume 146, Issue Suppl_1, Page A10305-A10305, November 8, 2022. Introduction:Conventional temporary pacemakers with percutaneous pacing leads limit patient mobility, create risks for infections, require removal procedures following completion of therapy and demand an additional collection of wired devices to monitor the status of the patient and to provide closed-loop operation. Recently reported wireless, bioresorbable pacemakers avoid the first set of disadvantages, but they must still be paired with conventional wired-based systems for cardiac monitoring, power delivery and control.Methods:We present a bioresorbable pacemaker that combines with a wirelessly networked collection of temporary, body-integrated devices to (1) power, control, and monitor processes of cardiac stimulation, (2) track cardiopulmonary status via comprehensive, multi-modal measurements, (3) provide patient-specific multi-haptic feedback on device and physiological status, and (4) support transient operation through bioresorption and gentle removal from the skin.Results:Data captured from various locations of the body yield detailed information of patient status, across various aspects of cardiopulmonary health and physical activity. The results define autonomous rate-adaptive pacing parameters to match metabolic demand via wireless powering of the bioresorbable module. Operation is possible over extended periods to match clinical needs, enabled by advanced mechanical designs and drug eluting configurations of the battery-free, bioresorbable pacemaker platform. Replacement of the cardiac module can occur in a manner that does not disrupt continuous pacing. The skin-interfaced devices can be easily peeled away for removal after patient recovery, due to their soft, flexible construction.Conclusions:We demonstrate for the first time that a bioresorbable pacemaker with transient closed-loop system is feasible in a clinically relevant, large animal and human whole heart model. Further improvements in this technology could open doors for out of hospital temporary pacing for varying periods of time, without the need for permanent hardware.

Leggi
Ottobre 2022