scholarly journals Leadless pacemakers: does location matter?

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
C Menexi ◽  
M Elrefai ◽  
M Abouelasaad ◽  
P Roberts

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Leadless pacemakers (LPs) provide a viable alternative for patients who have an indication for pacing where transvenous pacing is not desirable or possible. Registries have demonstrated stable performance associated with LPs. There is preference towards implanting LPs into the trabeculated septum rather than the apex or free wall. We report our experience with the impact of the implantation site on acute and long-term electrical performance of LPs. Methods We ran a retrospective analysis on the first 100 LPS implanted at our centre. Two independent observers reviewed the fluoroscopic images and post-implant chest x-rays to classify the LPs’ positions.  We obtained the recorded pacing threshold , R-wave amplitude and impedance of the devices at the time of implant and at the latest available routine device follow-up. We used one-way ANOVA testing to compare the acute and long-term electrical performance of the LPs between different implantation sites. Results We were able to classify the site of the LPs implants in a total of 90 patient. 84 Patients (60% male) 57.3± 22.16 years were included .23.8% of the patients presented with syncope.  Indications for pacing were symptomatic sinus node dysfunction (33.3%), high grade AV block (34.5%), bradyarrhythmia associated with atrial tachyarrhythmias (28.6%) and other indications (3.6%). We had a 100% successful implant rate, 85.7% required ≤2 attempts and 71.4% required one attempt. A total of 32 implants were in the apex (38.1%), 26 in mid-septum (30.9 %), 13 in the apical septum (15.5%), 12 on the septal aspect of the right ventricular inflow (14.3%) and 1 implant (1.2%) in the septum of the RV outflow tract. The follow up period of the 84 patients was 3.09 ± 1.97 years. 100% of the LPs had the pacing thresholds <2.0 V @0.24 ms at the time of implant. Pacing threshold, R-wave amplitude, and impedance averaged at 0.67 ± 0.41 V, 10.86 ± 5.41 mV, and 775 ± 193.28 Ohms respectively at the time of implantation and 0.66 ± 0.39 V, 14.08 ± 6.14 mV, and 564.29 ± 96.76 Ohms at the last device check. There was no statistically significant difference in either the pacing thresholds or the impedance between implant sites. Post hocTukey’s analysis (excluding the outflow tract case) demonstrated significant statistical difference in the R-wave amplitudes between implants at the apex and the mid-septum both at the time of implantation (12.9 ± 6.1 mV and 8.53 ± 2.84 mV; p = 0.0196) and at follow up (15.97 ± 5.35 mV and 11.52 ± 5.01 mV; p = 0.0415). There were no differences between other sites Conclusions Our analysis demonstrated that aside from the difference between the sensed R wave amplitudes between LPs implanted at the apex and those implanted at mid-septum , there was no statistically significant difference in the acute or the long term electrical performance of implanted LPs regardless of the implantation site. A limitation to our analysis is the relatively low number of LP implants included in our analysis. Abstract Figure. Mean of parameters by validated position

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Gianfranco Mitacchione ◽  
Marco Schiavone ◽  
Gianmarco Arabia ◽  
Francesca Salghetti ◽  
Manuel Cerini ◽  
...  

Abstract Aims Micra-VR transcatheter pacing system (TPS) has shown strong stability of electrical parameters over time. Nevertheless, a small percentage of patients develops high pacing threshold (PT) (>1 [email protected] ms) which can decrease the longevity of battery. Our study sought to investigate the intraoperative electrical parameters able to predict device electrical performances during the time. Methods and results Patients (pts) implanted with Micra-VR TPS from March 2018 to January 2021 were prospectively considered at the Cardiology Department of Spedali Civili Hospital (Brescia) and Luigi Sacco Hospital (Milan). R-wave sensing amplitude (mV), pacing impedance (Ohm), and PT ([email protected] ms) were recorded twice: upon Micra final positioning, and after removal of the delivery system. All pts received a follow-up visit at 1- and 12-month after discharge. Electrical parameters were recorded at each visit. A total of 93 pts underwent Micra-VR implantation were enrolled. When compared to the first assessment, R-wave amplitude increased of 19.1% at second control performed after 13 ± 4 min (+1.71 ± 0.2 mV, 95% CI: 1.4–2.02; P < 0.001). Conversely, PT significantly decreased of 22.1% at 12-month follow-up respect to baseline (−0.22 ± 0.03 V, 95% CI: −0.13 to − 0.31; P < 0.001) (Figure 1). Among patients with high PT, acute increase of R-wave sensing of 1.5 mV after 14 ± 4 min significantly predicted PT normalization (≤1 [email protected] ms) 12 months post-implant (R = 0.72, 95% CI: 0.13–0.33, P < 0.001) (Figure 2), with a sensitivity of 87.5% (95% CI: 0.61–0.98) and a specificity of 88.8% (95% CI: 0.51–0.99) (Figure 3). Conclusions A 1.5 mV increase in R-wave amplitude at implant time is predictive of PT normalization (<1.0 V/0.24 ms) at 12-month FU. This finding may have practical implications for device repositioning in case of HPT at implant. This parameter could be considered for acute device repositioning, particularly in HPT patients. 536 Figure


2019 ◽  
Vol 2019 ◽  
pp. 1-6 ◽  
Author(s):  
Joanna Wojtasik-Bakalarz ◽  
Zoltan Ruzsa ◽  
Tomasz Rakowski ◽  
Andreas Nyerges ◽  
Krzysztof Bartuś ◽  
...  

The most relevant comorbidities in patients with peripheral artery disease (PAD) are coronary artery disease (CAD) and diabetes mellitus (DM). However, data of long-term follow-up of patients with chronic total occlusion (CTO) are scarce. The aim of the study was to assess the impact of CAD and DM on long-term follow-up patients after superficial femoral artery (SFA) CTO retrograde recanalization. In this study, eighty-six patients with PAD with diagnosed CTO in the femoropopliteal region and at least one unsuccessful attempt of antegrade recanalization were enrolled in 2 clinical centers. Mean time of follow-up in all patients was 47.5 months (±40 months). Patients were divided into two groups depending on the presence of CAD (CAD group: n=45 vs. non-CAD group: n=41) and DM (DM group: n=50 vs. non-DM group: n=36). In long-term follow-up, major adverse peripheral events (MAPE) occurred in 66.6% of patients with CAD vs. 36.5% of patients without CAD and in 50% of patients with DM vs. 55% of non-DM subjects. There were no statistical differences in peripheral endpoints in both groups. However, there was a statistically significant difference in all-cause mortality: in the DM group, there were 6 deaths (12%) (P value = 0.038). To conclude, patients after retrograde recanalization, with coexisting CTO and DM, are at higher risk of death in long-term follow-up.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Kano ◽  
K Nasu ◽  
M Habara ◽  
T Shimura ◽  
M Yamamoto ◽  
...  

Abstract Background For recanalization of coronary chronic total occlusion (CTO) lesions, subintimal guidewire tracking in both antegrade and retrograde approaches are commonly used. Purpose This study aimed to assess the impact of subintimal tracking on long-term clinical outcomes after recanalization of CTO lesions. Methods Between January 2009 and December 2016, 474 CTO lesions (434patients) were successfully recanalized in our center. After guidewire crossing in a CTO lesion, those lesions were divided into intimal tracking group (84.6%, n=401) and subintimal tracking group (15.4%, n=73) according to intravascular ultrasound (IVUS) findings. Long-term clinical outcomes including death, target lesion revascularization (TLR), target vessel revascularization (TVR) were compared between the two groups. In addition, the rate of re-occlusion after successful revascularization was also evaluated. Results The median follow-up period was 4.7 years (interquartile range, 2.8–6.1). There was no significant difference of the rate of cardiac death between the two groups (intimal tracking vs. subintimal tracking: 7.0% vs. 4.1%; hazard ratio, 0.61; 95% confidence interval [CI], 0.19 to 2.00; p=0.41), TLR (14.3% vs. 16.2%; hazard ratio, 1.34; 95% CI, 0.71 to 2.53; p=0.37), and TVR (17.5% vs. 20.3%; hazard ratio, 1.27; 95% CI, 0.72 to 2.23; p=0.42). However, the rate of re-occlusion was significantly higher in the subintimal tracking group than intimal tracking group at 3-years re-occlusion (4.2% vs. 14.5%; log-rank test, p=0.002, Figure). In the multivariate COX regression, subintimal guidewire tracking was an independent predictor of re-occlusion after CTO recanalization (HR: 5.40; 95% CI: 2.11–13.80; p<0.001). Figure 1 Conclusions Subintimal guidewire tracking for recanalization of coronary CTO was associated with significantly higher incidence of target lesion re-occlusion during long-term follow-up period.


1994 ◽  
Vol 12 (9) ◽  
pp. 1778-1782 ◽  
Author(s):  
M Omne-Pontén ◽  
L Holmberg ◽  
P O Sjödén

PURPOSE To evaluate, in a long-term follow-up study of consecutive patients (N = 99), the impact of surgery--breast-conserving treatment (BCT) versus mastectomy (MT)--on psychosocial adjustment among women with breast cancer, pTNM stage I/II. PATIENTS AND METHODS Semistructured interviews were conducted at a median of 6 years (range, 5.8 to 8.1) after primary surgery. Sixty-six women were available for the long-term follow-up study. Twenty-six women had been treated with BCT and 40 with MT. RESULTS No statistically significant differences were found between the two groups concerning psychosocial adjustment, as measured by the Social adjustment Scale (SAS). In general, the levels of maladjustment were lower than at 13 months postoperatively, but 10% still showed maladjustment. Sixty percent of the women were unwilling to show themselves naked, and 22% felt that they had become less attractive because of the surgical treatment. In an explorative part of the interview, 68% of the women complained about how they had been informed of the diagnosis. A tendency toward a significant difference was found in the relation between previous maladjustment and a negative experience at the time of diagnosis (P = .07). CONCLUSION Few data are available on long-term follow-up results with regard to psychosocial adjustment among women after breast cancer surgery. This study provides the important information that there are no differences in patient psychosocial adjustment that can be ascribed to the type of surgery at 6-year follow-up evaluation.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yong-Sheng Liu ◽  
Mei Wei ◽  
Le Wang ◽  
Gang Liu ◽  
Guo-Ping Ma ◽  
...  

Abstract Background Subclinical hypothyroidism (SCH) is reportedly associated with an increased risk of adverse events in patients undergoing percutaneous coronary intervention (PCI). The prognostic significance of SCH in the elderly was poorly defined. The purpose of this study was to evaluate the association between SCH and long-term outcomes in older patients undergoing PCI. Methods Three thousand one hundred sixty-eight patients aged 65 years or older who underwent PCI from January 2012 to October 2014 were included. Patients were divided into SCH group (n = 320) and euthyroidism (ET) group (n = 2848) based on thyroid function test. Cox proportional hazard regression analyses were used to estimate the relative risks (RRs) of all-cause death and cardiac death for patients with SCH during a 4-year follow-up period. Results There were 227 deaths during the follow-up period including 124 deaths caused by cardiac events. There was no significant difference in mortality rate between the SCH group and the ET group (p > 0.05). After adjustment for covariates, compared with patients with ET, the RRs of death from all-cause and cardiac in patients with SCH were 1.261 (95%CI: 0.802–1.982, p = 0.315) and 1.231 (95%CI: 0.650–2.334, p = 0.524), respectively. When SCH was stratified by age, gender, and degree of thyroid-stimulating hormone elevation, no significant associations were also found in any stratum. Conclusion Our investigation revealed that SCH was negatively associated with the outcome of PCI in older patients.


Author(s):  
Wenlong Dai ◽  
Baojing Guo ◽  
Chen Cheng Dai ◽  
Jian zeng Dong

Objective: To explore the safety and feasibility of left bundle branch area pacing (LBBAP) in children. Methods: This study observed 12 children attempted LBBAP from 2019 to 2021 in our department prospectively. Clinical data, pacing parameters, electrocardiograms, echocardiographic measurements and complications were recorded at implant and during follow-up. Results: The 12 patients aged between 3 and 14ys and weighted from 13 to 48kg. 11 patients were diagnosed with third-degree AVB and 1 patient (case 4) suffered from cardiac dysfunction due to right ventricular apical pacing (RVAP). LBBAP was successfully achieved in all patients with narrow QRS complexes. LVEF of case 4 recovered on the 3rd day after LBBAP. The median of LVEDD Z score of the 12 patients decreased from 1.75 to1.05 3 months after implantation (p<0.05). The median of paced QRS duration was 103ms. The median of pacing threshold, R-wave amplitude and impedance were 0.85V, 15mV and 717Ω respectively and remained stable during follow-up. No complications such as loss of capture, lead dislodgement or septal perforation occurred. Conclusions: LBBAP can be performed safely in children with narrow QRS duration and stable pacing parameters. Cardiac dysfunction caused by long-term RVAP can be corrected by LBBAP quickly.


Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2635-2635
Author(s):  
Jack Bartram ◽  
Rachel Clack ◽  
Rachel Wade ◽  
Ajay J Vora ◽  
Jeremy Hancock ◽  
...  

Abstract Background Sensitive measurement of minimal residual disease (MRD) at the end of induction, to a minimum limit of detection of 0.01% is known to highlight a large group of patients (>40%) with an excellent (>90%) short term EFS. The UKALL 2003 study showed treatment reduction is feasible in children and young adults with no MRD >0.01% at day 28 of therapy (Vora et al, Lancet Oncology 2013). Nevertheless, follow up in that study and other recent trials is relatively short, raising concerns about using this result to infer the safety of further therapy reduction in the future. In order to provide insight into the applicability of this result, we have studied the longer term outcome of patients with MRD <0.01% at day 28 in our non-interventional pilot studies; UK ALL 97, 97/99 and 2003. Methods We examined 225 patients treated on one of the 3 trials between 1997 and 2003 for whom MRD results were available. The UK Medical Research Council (MRC) protocol ALL97 (1997–1999) had a 5 year EFS of 74% and OS 83.5%, and its amended version ALL 97/99 (1999–2002) had a 5 year of EFS 80% and OS 88%. These studies both compared in a randomised fashion, the efficacy and toxicity of dexamethasone with prednisolone, and 6-thioguanine with 6-Mercaptopurine. The successor trial ALL 2003, had a 5 year EFS of 87.7% and an OS of 91.3%, using more intensive induction including dexamethasone for all patients and PEGylated asparaginase. These trials provided an opportunity to determine the impact of MRD clearance on EFS and OS, with extended follow-up. MRD status at the end of induction chemotherapy was defined as low risk if no MRD was detected by at least one marker sensitive to 0.01%. In the ALL 97 study, MRD was measured by radiolabelled allele specific oligoprobing (sensitive to 0.01%); in ALL 99 and 2003 it was measured using the Euro-MRD RQ PCR of antigen receptor genes (quantitative range 0.01%). Results 100 patients (44%) were low risk by MRD at end of induction. The median range of follow-up across the trials was 7 years 4 months to 12 years 11 months (longest individual follow up 14 years 1 month). There was no significant difference in NCI risk group between MRD positive and negative patients. Discussion Our pilot data defines a cohort of 44% of children with ALL who have a very good EFS and an excellent long term OS. Of 100 day 28 MRD low risk patients, 6 died: 1 because of toxicity at 1 month post diagnosis; and 1 from influenza 147 months post diagnosis whilst in CR; only 4 patients had relapses, at 17, 45, 74 and 125 months post diagnosis. Conclusion The excellent outcome for childhood ALL with low risk MRD after induction chemotherapy is sustained in the intermediate to long term. This result supports the potential for further reduction in therapy in subsequent trials for these children, without risk of worsening outcome. Disclosures: No relevant conflicts of interest to declare.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
X Liu ◽  
M Gu ◽  
Y.R Hu ◽  
W Hua ◽  
S Zhang

Abstract Background His-bundle pacing (HBP) is recognized as the most physiological way of pacing but with less study focused on electrical characteristics in different site. Purpose We aimed to evaluate the differences of pacing and echocardiographic parameters between atrial and ventricular side His-bundle pacing. Methods Patients who successfully underwent HBP implantation from September 2018 to August 2019 were retrospectively analyzed. All patients were assigned to atrial-side HBP (aHBP) group or ventricular-side HBP (vHBP) group according to the location of the His-bundle pacing lead, which was confirmed by two methods including postoperative echocardiography and visualization of tricuspid valve annulus (TVA). The pacing and echocardiographic parameters were compared between two groups during the procedure and at 3-month follow-up. Results A total of 71 bradycardia patients who successfully underwent HBP implantation and confirmed lead position were included. Among them, twenty-seven were assigned to aHBP group and the other 44 were assigned to vHBP group with no significant differences in baseline clinical characteristics between two groups. During the procedure, the proportion of selective HBP was significantly higher (77.8% vs. 11.4%; P&lt;0.01) and the intra-procedural HV intervals was significantly longer (50.85±6.53 ms vs. 42.95±6.02 ms, P&lt;0.01) in aHBP group than in vHBP group. The capture threshold in vHBP group was significantly lower than in aHBP group at implantation (0.92±0.22 V/1.0ms vs. 1.05±0.26 V/1.0ms, P=0.03) and remain significantly difference after 3-month follow-up (0.98±0.23 V/1.0ms vs. 1.15±0.44 V/1.0ms, P=0.03). The R-wave amplitude was significantly higher in vHBP group than in aHBP group at implantation (5.82±2.52 mV vs. 3.74±1.81 mV, P&lt;0.01), and these differences still persisted during follow-up (5.88±2.51 mV vs. 3.67±1.61 mV, P&lt;0.01). During 3-month follow-up, an increase in the capture threshold &gt;1 V/1.0ms was seen in 2 cases in aHBP group while all patients remained stable in vHBP group. One patient developed a pocket hematoma in aHBP group compared to none in vHBP group. None of deterioration of tricuspid regurgitation and other procedure-related complications were observed during 3-month follow-up. Conclusions Ventricular side His-bundle pacing can achieve favourable pacing parameters including a lower pacing threshold and a higher R-wave amplitude than atrial side His-bundle pacing, which may be an ideal pacing strategy for patients in need of ventricular pacing. Funding Acknowledgement Type of funding source: None


2020 ◽  
Author(s):  
Yong-Sheng Liu ◽  
Mei Wei ◽  
Le Wang ◽  
Gang Liu ◽  
Guo-Ping Ma ◽  
...  

Abstract BackgroundSubclinical hypothyroidism (SCH) is reportedly associated with an increased risk of adverse events in patients undergoing percutaneous coronary intervention (PCI). The prognostic significance of SCH in the elderly was poorly defined. The purpose of this study was to evaluate the association between SCH and long-term outcomes in older patients undergoing PCI. Methods and Results 3168 patients aged 65 years or older who underwent PCI from January 2012 to October 2013 were included. Patients were divided into SCH group (n = 320) and euthyroidism (ET) group (n = 2848) based on thyroid function test. Cox proportional hazard regression analyses were used to estimate the relative risks (RRs) of all-cause death and cardiac death for patients with SCH during a 4-year follow-up period. There were 227 deaths during the follow-up period including 124 deaths caused by cardiac events. There was no significant difference in mortality rate between the SCH group and the ET group (p > 0.05). After adjustment for covariates, compared with patients with ET, the RRs of death from all-cause and cardiac in patients with SCH were 1.261 (95%CI: 0.802–1.982, p = 0.315) and 1.231 (95%CI: 0.650–2.334, p = 0.524), respectively. When SCH was stratified by age, gender, and degree of thyroid-stimulating hormone elevation, no significant associations were also found in any stratum. Conclusion Our investigation revealed that SCH was negatively associated with the outcome of PCI in older patients.


2021 ◽  
Author(s):  
Yong-Sheng Liu ◽  
Mei Wei ◽  
Le Wang ◽  
Gang Liu ◽  
Guo-Ping Ma ◽  
...  

Abstract Background Subclinical hypothyroidism (SCH) is reportedly associated with an increased risk of adverse events in patients undergoing percutaneous coronary intervention (PCI). The prognostic significance of SCH in the elderly was poorly defined. The purpose of this study was to evaluate the association between SCH and long-term outcomes in older patients undergoing PCI.Methods and Results 3168 patients aged 65 years or older who underwent PCI from January 2012 to October 2013 were included. Patients were divided into SCH group (n=320) and euthyroidism (ET) group (n=2848) based on thyroid function test. Cox proportional hazard regression analyses were used to estimate the relative risks (RRs) of all-cause death and cardiac death for patients with SCH during a 4-year follow-up period. There were 227 deaths during the follow-up period including 124 deaths caused by cardiac events. There was no significant difference in mortality rate between the SCH group and the ET group (p>0.05). After adjustment for covariates, compared with patients with ET, the RRs of death from all-cause and cardiac in patients with SCH were 1.261 (95%CI: 0.802-1.982, p=0.315) and 1.231 (95%CI: 0.650-2.334, p=0.524), respectively. When SCH was stratified by age, gender, and degree of thyroid-stimulating hormone elevation, no significant associations were also found in any stratum. Conclusion Our investigation revealed that SCH was negatively associated with the outcome of PCI in older patients.


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