New-Onset Left Ventricular Dysfunction After Left Bundle Branch Pacing.

Left bundle branch pacing (LBBP) provides stable pacing parameters and has been suggested as an alternative for right ventricular pacing and cardiac resynchronization therapy. The aim of the study was to assess the incidence and etiology of new-onset left ventricular dysfunction (NOLVD) following LBBP in patients with baseline normal left ventricular (LV) function and cardiomyopathy patients with normalized LV function. Patients undergoing successful LBBP for symptomatic bradyarrhythmia or as an alternative to cardiac resynchronization therapy were included. Normalization of LV function was defined as improvement in LV ejection fraction to ≥50%. Patients with baseline normal LV function and those with recovered LV function after LBBP constituted the study group. Loss of conduction system capture (LOCSC) was defined as complete or partial loss of right bundle branch delay pattern along with inability to demonstrate capture transition during threshold assessment. A total of 426 patients were included; 59% (n = 250) had baseline normal LV function (group I) and 41% (n = 176) had recovered LV function after LBBP (group II). Mean follow-up duration of 28.3 ± 16.7 months. NOLVD was noted in 3.75% (n = 16; group I, n = 5, and group II, n = 11) of patients. The etiologies for NOLVD were LOCSC in 62.5% (n = 10), suboptimal atrioventricular (AV) delay in 18.7% (n = 3), atrial fibrillation in 6.3% (n = 1), and idiopathic in 12.5% (n = 2). LOCSC occurred at a mean interval of 9.2 ± 6.4 months after the initial implantation. Reinterventions (n = 6) including lead repositioning, AV delay optimization, and AV junction ablation resulted in renormalization of LV function in all 6 patients. Periodic assessment in device clinic is required because NOLVD from reversible causes can occur during follow-up in patients after LBBP.

Ponnusamy SS ，Ganesan V ，Nagalingam S ，Ramalingam V ，Mariappan S ，Moghal H ，Murugan S ，Kumar M ，Joseph R ，Vijayaraman P ... -  《-》

Predictors of failed left bundle branch pacing implant in heart failure with reduced ejection fraction: Importance of left ventricular diameter and QRS morphology.

Left bundle branch pacing (LBBP) is considered an alternative to cardiac resynchronization therapy (CRT). However, LBBP is not suitable for all patients with heart failure. The aim of our study was to identify predictors of unsuccessful LBBP implantation in CRT candidates. A cohort of consecutive patients with indications for CRT were included. Clinical, echocardiographic, and electrocardiographic variables were prospectively recorded. A total of 187 patients were included in the analysis. LBBP implantation was successful in 152 of 187 patients (81.2%) and failed in 35 of 187 patients (18.7%). The causes of unsuccessful implantation were unsatisfactory paced QRS morphology (28 of 35 [80%]), inability to screw the helix (4 of 35 [11.4%]), lead instability (2 of 35 [5.7%]), and high pacing thresholds (1 of 35 [2.8%]). The left ventricular end-diastolic diameter (LVEDD), non-LBBB (left bundle branch block) QRS morphology, and QRS width were predictors of failed implantation according to the univariate analysis. According to the multivariate regression analysis, LVEDD (odds ratio 1.31 per 5-mm increase; 95% confidence interval 1.05-1.63 per 5-mm increase; P = .02) and non-LBBB (odds ratio 3.07; 95% confidence interval 1.08-8.72; P = .03) were found to be independent predictors of unsuccessful LBBP implantation. An LVEDD of 60 mm has 60% sensitivity and 71% specificity for predicting LBBP implant failure. When LBBP was used as CRT, LVEDD and non-LBBB QRS morphology predicted unsuccessful implantation. Non-LBBB triples the likelihood of failed implantation independent of LVEDD. Caution should be taken when considering these parameters to plan the best pacing strategy for patients.

Graterol FR ，Pujol-López M ，Borràs R ，Ayala B ，Uribe L ，Guasch E ，Regany-Closa M ，Niebla M ，Carro E ，Guichard JB ，Castel MÁ ，Arbelo E ，Porta-Sánchez A ，Sitges M ，Brugada J ，Roca-Luque I ，Doltra A ，Mont L ，Tolosana JM ... -  《-》

LOCAlizaTion and clinical corrElation of Left Bundle Branch Pacing lead: Insights from a computed tomographic angiography (LOCATE LBBP) study.

Left bundle branch pacing (LBBP) provides physiological activation with stable pacing parameters. However, there is a paucity of data on direct assessment of lead stability. The purpose of this study was to assess the stability of an LBBP lead using computed tomographic angiography (CTA) during medium-term follow-up and to correlate the anatomic location of the lead and electrophysiological characteristics of LBBP. Consecutive patients with successful LBBP using a lumenless lead were included. Patients without LBB capture, contrast allergy, and renal dysfunction were excluded. CTA was performed postimplantation and at 6 months. Primary endpoint was defined as consistent left bundle branch (LBB) capture with helix tip separated from the left ventricular (LV) blood pool by <2 mm by CTA at 6 months. Secondary endpoints were defined as loss of conduction system capture (LOCSC) or perforation with complete capture loss at 6 months. Overall, 67 of 105 patients who underwent CTA after successful LBBP were included. Mean follow-up was 33.8 ± 4.4 months. Nonselective to selective capture transition was noted in 82% (n = 55). The lead remained stable at 6 months, with no difference in mean distance between LV blood pool and helix tip (-0.5 ± 1.8 mm vs -0.1 ± 2.1 mm; P = .23). Primary endpoint was achieved in 89.5% (n = 60). Consistent LBB capture (group I) at 6 months was noted in 94% (n = 63). LOCSC (group 2) was noted in 6% (n = 4) at 6 months. No perforation into the LV cavity with complete loss of capture was seen. Lead displacement by >2 mm away from the LV blood pool (sensitivity 100%; specificity 95%) and lack of nonselective to selective capture transition during implantation (odds ratio 18.0; 95% confidence interval 1.7-192.7; P = .01) were LOCSC predictors. Deep septal deployment of the lead in the LV subendocardium for LBB capture is safe, with 94% of patients showing consistent conduction system capture during follow-up.

Ponnusamy SS ，Barka N ，Yang Z ，Ganesan V ，Murugan M ，Moghal H ，Ramalingam V ，Kumar S ，Ramamoorthy R ，Ramu K ，Bhuvaneshwari VN ，Selvaraj D ，Alagar AS ，Dhanapal J ，Selvaraj R ，Diana M ，Vijayaraman P ... -  《-》

Transseptal Transition Patterns During Left Bundle Branch Area Lead Implantation.

Continuous deep septal pacing and signal recording during implantation of left bundle branch pacing (LBBP) lead enables to monitor beat-to-beat changes of electrocardiogram (ECG) and myocardial current of injury (COI) as the lead crosses the septum. This study aimed to characterize patterns of continuous QRS, ST-T, and COI change for monitoring of the lead depth and instantaneous determination of the obtained capture type (LBBP vs left ventricular septal pacing [LVSP]). The ECG and COI during lead implantation were scrutinized for sudden changes of V6 R-wave peak time, V1 initial and terminal R-wave amplitude, V3-V6 R-wave amplitude, repolarization pattern and S-wave amplitude in I, V5-V6, and COI drop. The sudden and gradual transition patterns were diagnosed depending on the presence or absence of the above beat-to-beat ECG phenomena, respectively. A total of 212 pacemaker recipients were analyzed; LBBP and LVSP were obtained in 77.4% and 22.6%, respectively. There were 4.7 ± 2.1 and 0.2 ± 0.6 beat-to-beat phenomena in LBBP and LVSP patients, respectively. The sudden transition pattern, recognized in 80.7%, had sensitivity and specificity for LBBP diagnosis of 98.8% and 81.2%, respectively. A sudden drop of COI (29.4 ± 8.5 mV to 12.8 ± 4.9 mV) was observed in 53.9% patients (LBBP was simultaneously obtained in 92.7%). Capture of left bundle branch during lead penetration is a beat-to-beat phenomenon. Two transseptal transition patterns were identified: 1) sudden, which is typical for obtaining LBBP; and 2) gradual, which is typical for obtaining LVSP. A sudden COI drop, a very observable phenomenon, also identified reaching the left subendocardial area.

Jastrzębski M ，Kiełbasa G ，Moskal P ，Bednarek A ，Rajzer M ，Burri H ，Curila K ，Vijayaraman P ... -  《-》

Comparison of Two Modern Survival Prediction Tools, SORG-MLA and METSSS, in Patients With Symptomatic Long-bone Metastases Who Underwent Local Treatment With Surgery Followed by Radiotherapy and With Radiotherapy Alone.

Survival estimation for patients with symptomatic skeletal metastases ideally should be made before a type of local treatment has already been determined. Currently available survival prediction tools, however, were generated using data from patients treated either operatively or with local radiation alone, raising concerns about whether they would generalize well to all patients presenting for assessment. The Skeletal Oncology Research Group machine-learning algorithm (SORG-MLA), trained with institution-based data of surgically treated patients, and the Metastases location, Elderly, Tumor primary, Sex, Sickness/comorbidity, and Site of radiotherapy model (METSSS), trained with registry-based data of patients treated with radiotherapy alone, are two of the most recently developed survival prediction models, but they have not been tested on patients whose local treatment strategy is not yet decided. (1) Which of these two survival prediction models performed better in a mixed cohort made up both of patients who received local treatment with surgery followed by radiotherapy and who had radiation alone for symptomatic bone metastases? (2) Which model performed better among patients whose local treatment consisted of only palliative radiotherapy? (3) Are laboratory values used by SORG-MLA, which are not included in METSSS, independently associated with survival after controlling for predictions made by METSSS? Between 2010 and 2018, we provided local treatment for 2113 adult patients with skeletal metastases in the extremities at an urban tertiary referral academic medical center using one of two strategies: (1) surgery followed by postoperative radiotherapy or (2) palliative radiotherapy alone. Every patient's survivorship status was ascertained either by their medical records or the national death registry from the Taiwanese National Health Insurance Administration. After applying a priori designated exclusion criteria, 91% (1920) were analyzed here. Among them, 48% (920) of the patients were female, and the median (IQR) age was 62 years (53 to 70 years). Lung was the most common primary tumor site (41% [782]), and 59% (1128) of patients had other skeletal metastases in addition to the treated lesion(s). In general, the indications for surgery were the presence of a complete pathologic fracture or an impending pathologic fracture, defined as having a Mirels score of ≥ 9, in patients with an American Society of Anesthesiologists (ASA) classification of less than or equal to IV and who were considered fit for surgery. The indications for radiotherapy were relief of pain, local tumor control, prevention of skeletal-related events, and any combination of the above. In all, 84% (1610) of the patients received palliative radiotherapy alone as local treatment for the target lesion(s), and 16% (310) underwent surgery followed by postoperative radiotherapy. Neither METSSS nor SORG-MLA was used at the point of care to aid clinical decision-making during the treatment period. Survival was retrospectively estimated by these two models to test their potential for providing survival probabilities. We first compared SORG to METSSS in the entire population. Then, we repeated the comparison in patients who received local treatment with palliative radiation alone. We assessed model performance by area under the receiver operating characteristic curve (AUROC), calibration analysis, Brier score, and decision curve analysis (DCA). The AUROC measures discrimination, which is the ability to distinguish patients with the event of interest (such as death at a particular time point) from those without. AUROC typically ranges from 0.5 to 1.0, with 0.5 indicating random guessing and 1.0 a perfect prediction, and in general, an AUROC of ≥ 0.7 indicates adequate discrimination for clinical use. Calibration refers to the agreement between the predicted outcomes (in this case, survival probabilities) and the actual outcomes, with a perfect calibration curve having an intercept of 0 and a slope of 1. A positive intercept indicates that the actual survival is generally underestimated by the prediction model, and a negative intercept suggests the opposite (overestimation). When comparing models, an intercept closer to 0 typically indicates better calibration. Calibration can also be summarized as log(O:E), the logarithm scale of the ratio of observed (O) to expected (E) survivors. A log(O:E) > 0 signals an underestimation (the observed survival is greater than the predicted survival); and a log(O:E) < 0 indicates the opposite (the observed survival is lower than the predicted survival). A model with a log(O:E) closer to 0 is generally considered better calibrated. The Brier score is the mean squared difference between the model predictions and the observed outcomes, and it ranges from 0 (best prediction) to 1 (worst prediction). The Brier score captures both discrimination and calibration, and it is considered a measure of overall model performance. In Brier score analysis, the "null model" assigns a predicted probability equal to the prevalence of the outcome and represents a model that adds no new information. A prediction model should achieve a Brier score at least lower than the null-model Brier score to be considered as useful. The DCA was developed as a method to determine whether using a model to inform treatment decisions would do more good than harm. It plots the net benefit of making decisions based on the model's predictions across all possible risk thresholds (or cost-to-benefit ratios) in relation to the two default strategies of treating all or no patients. The care provider can decide on an acceptable risk threshold for the proposed treatment in an individual and assess the corresponding net benefit to determine whether consulting with the model is superior to adopting the default strategies. Finally, we examined whether laboratory data, which were not included in the METSSS model, would have been independently associated with survival after controlling for the METSSS model's predictions by using the multivariable logistic and Cox proportional hazards regression analyses. Between the two models, only SORG-MLA achieved adequate discrimination (an AUROC of > 0.7) in the entire cohort (of patients treated operatively or with radiation alone) and in the subgroup of patients treated with palliative radiotherapy alone. SORG-MLA outperformed METSSS by a wide margin on discrimination, calibration, and Brier score analyses in not only the entire cohort but also the subgroup of patients whose local treatment consisted of radiotherapy alone. In both the entire cohort and the subgroup, DCA demonstrated that SORG-MLA provided more net benefit compared with the two default strategies (of treating all or no patients) and compared with METSSS when risk thresholds ranged from 0.2 to 0.9 at both 90 days and 1 year, indicating that using SORG-MLA as a decision-making aid was beneficial when a patient's individualized risk threshold for opting for treatment was 0.2 to 0.9. Higher albumin, lower alkaline phosphatase, lower calcium, higher hemoglobin, lower international normalized ratio, higher lymphocytes, lower neutrophils, lower neutrophil-to-lymphocyte ratio, lower platelet-to-lymphocyte ratio, higher sodium, and lower white blood cells were independently associated with better 1-year and overall survival after adjusting for the predictions made by METSSS. Based on these discoveries, clinicians might choose to consult SORG-MLA instead of METSSS for survival estimation in patients with long-bone metastases presenting for evaluation of local treatment. Basing a treatment decision on the predictions of SORG-MLA could be beneficial when a patient's individualized risk threshold for opting to undergo a particular treatment strategy ranged from 0.2 to 0.9. Future studies might investigate relevant laboratory items when constructing or refining a survival estimation model because these data demonstrated prognostic value independent of the predictions of the METSSS model, and future studies might also seek to keep these models up to date using data from diverse, contemporary patients undergoing both modern operative and nonoperative treatments. Level III, diagnostic study.

Lee CC ，Chen CW ，Yen HK ，Lin YP ，Lai CY ，Wang JL ，Groot OQ ，Janssen SJ ，Schwab JH ，Hsu FM ，Lin WH ... -  《-》