Cardiac Resynchronization Therapy Procedures Research Articles

Left ventricular lead implantation failure in an unselected nationwide cohort

Left ventricular (LV) lead implantation is often the most challenging aspect of cardiac resynchronization therapy (CRT) procedures; early studies reported implant failure rates in ∼10% of cases. The purpose of this study was to define rates, reasons for, and factors independently associated with LV lead implant failure. We studied patients with left bundle branch block and ejection fraction ≤ 35% who underwent planned de novo transvenous CRT implantation (2010-2016) and were reported to the National Cardiovascular Data Registry ICD Registry. Independent predictors of LV lead implant failure were determined using logistic regression; age, sex, and variables with a univariate P value of <.15 were considered for inclusion in the model. Of the 111,802 patients who underwent a planned CRT procedure, 3.6% of patients (n = 3979) had LV lead implant failure. Reasons for implant failure included venous access (7.5%), coronary sinus access (64.3%), tributary vein access (13.5%), coronary sinus dissection (7.6%), unacceptable threshold (4.4%), and diaphragmatic stimulation (1.7%). Significant independent predictors of LV lead implant failure included younger age (odds ratio [OR] 1.01; 95% confidence interval [CI] 0.1.01-1.02), female sex (OR 1.38; 95% CI 1.29-1.47), black race (vs white, OR 1.44; 95% CI 1.32-1.57), Hispanic ethnicity (OR 1.23; 95% CI 1.08-1.40), QRS duration (OR 1.055 per 10 ms; 95% CI 1.038-1.072 per 10 ms), obstructive sleep apnea (OR 1.14; 95% CI 1.04-1.24), and implant by a physician without specialized training (vs electrophysiology trained, OR 1.53; 95% CI 1.34-1.76). LV lead implant failure is uncommon in the current era and is most commonly due to coronary sinus access failure. Predictors of LV lead implant failure included younger age, female sex, black race, Hispanic ethnicity, increased QRS duration, sleep apnea, and absence of electrophysiology training.

Biventricular or Conduction System Pacing for Cardiac Resynchronization Therapy: A Strategy for Cardiac Resynchronization Based on a Hybrid Approach

Cardiac resynchronization therapy (CRT) is usually performed with biventricular pacing (BiVP), but recently, conduction system pacing (CSP) has been proposed as an alternative in case of BiVP failure. The aim of this study is to define an algorithm to choose between BiVP and CSP resynchronization using the interventricular conduction delays (IVCD) as a guide. Consecutive patients from January 2018 to December 2020 with an indication for CRT were prospectively enrolled in the study group (delays-guided resynchronization group, DRG). A treatment algorithm based on IVCD was used to decide whether to leave the left ventricular (LV) lead to perform BiVP or pull it out and perform CSP. Outcomes from the DRG group were compared to a historical cohort of CRT patients who underwent CRT procedures between January 2016 and December 2017 (resynchronization standard guide group, SRG). The primary endpoint was a composite of cardiovascular mortality, heart failure (HF) hospitalization, or HF event at 1 year after the date of intervention. The study population consisted of 292 patients, of which 160 (54.8%) were in the DRG and 132 (45.2%) in the SRG. In the DRG, 41 of 160 patients underwent CSP based on the treatment algorithm (25.6%). The primary endpoint was significantly higher in the SRG (48/132, 36.4%) compared to the DRG (35/160, 21.8%) (hazard ratio (HR): 1.72; 95% confidence interval (CI): 1.12-2.65; p = 0.013). A treatment algorithm based on IVCD shifted one patient out of every four from BiVP to CSP, with consequent reduction in the primary endpoint after implantation. Therefore, its application could be useful to determine whether to perform BiVP or CSP.

986 LEFT VENTRICULAR LEAD PLACEMENT FOR BIVENTRICULAR PACING INTO A LEFT LATERAL VEIN IN PATIENT WITH CONGENITAL ATRESIA OF THE CORONARY SINUS OSTIUM WHO UNDERWENT AORTIC VALVE REPLACEMENT

Abstract Introduction Coronary sinus ostial atresia (CSOA) is a rare congenital heart anomaly consisting in the occlusion of the coronary sinus (CS) outlet in the right atrium. It is one of the causes of placement left lead failure in CS during cardiac resynchronization therapy (CRT) device implantation. The persistence of the left superior vena cava is the most common pathway that allows venous blood flow to drain into the right atrium and can represent a new possible way to reach a left ventricular vein from the CS. Methods A 66-year-old male suffering from sarcoidosis was studied after an episode of syncope under exertion. EKG showed a 1st degree atrioventricular block and a left bundle branch block (LBBB) with wide QRS (170 ms). Echocardiography found left ventricle dilatation, severe systolic dysfunction, and a severe low-flow low-gradient aortic stenosis for which he underwent aortic valve replacement. After surgery and finding of 2nd degree type II atrioventricular block, CRT implant was performed but the procedure was complicated by the finding of CSOA. The insertion of the left quadripolar lead along a left branch of the occluded CS was achieved with a push-and-pull technique of the lead over a guidewire, after the retrieval and the cannulation of the persistent left superior vena cava. Results A new approach was applied on a rare case of CSOA found during CRT procedure. The contrast medium (CM) in the left subclavian vein revealed the existence of the left superior vena cava that was than cannulated. CM injection in CS highlighted a posterior left branch that was approached with a specific guidewire and a subselector after selective venography. With a fine technique of sliding of the lead on a tensioned guidewire, the quadripolar catheter was successfully placed in the left ventricular vein. Left-ventricle-right ventricle delays and catheter thresholds were tested and a final QSR duration of 90 msec in CRT mode was obtained. Conclusions This case-report shows a complex technique, reported in parallel with other similar procedures, to help the approach toward a rare anatomical variant of CSOA accompanied by persistent left superior vena cava when a CRT implant is needed after cardiac valve surgery in a patient suffering from sarcoidosis.

Usefulness of Decapolar catheter via femoral approach on CS cannulation during CRT device implantation.

IntroductionCardiac resynchronization therapy (CRT) device insertion comprises of a transvenous pacing lead implanted in posterolateral branch of the coronary sinus (CS) for left ventricular (LV) pacing, in addition to leads in the right ventricle and right atrium. In patients undergoing CRT device implantation, failure of CS cannulation was earlier reported to be around 10% but has come down to about 4% in recent years. Although the use of electrophysiology (EP) catheter has been reported during CRT procedures but femoral approach to place decapolar catheter as fluoroscopic guide for CS ostium cannulation during LV lead implantation has not been evaluated.Materials and methodsThe aim of the study was to compare fluoroscopy time during CRT procedure between conventional technique and using decapolar EP catheter via femoral approach as fluoroscopic marker to cannulate CS.ResultsThis study included 21 patients. Group 1 (using decapolar catheter) had 12 patients and group 2 (using the conventional technique) had 9 patients. CS cannulation was successful in all 21 cases. The mean fluoroscopy time for the CS cannulation and LV lead placement in group 1 was 10.7 (±1.03) min and in group 2 was 19.1 (±1.51) min. This difference in mean fluoroscopy time for the CS cannulation and LV lead placement was statistically significant with p < .05.ConclusionThis study highlights the usefulness of decapolar catheter via femoral approach as a fluoroscopic guide for CS cannulation during CRT device implantation. The decreased fluoroscopic time results in decreased radiation exposure to not only the patient but also to the operator.

Orthodromic and Antidromic Snare Techniques for Left Ventricular Lead Implantation in Cardiac Resynchronization Therapy

The snare technique can be used to overcome unsuitable cardiac venous anatomies for left ventricular (LV) lead implantation in cardiac resynchronization therapy (CRT) procedures. However, limited data exist regarding performance of the snare technique. We classified 262 patients undergoing CRT procedure into the snare (n = 20) or conventional group (n = 242) according to the LV lead implantation method. We compared the safety, efficacy, and composite outcome (all-cause death and heart failure readmission) at 3 years post-implant between the snare and conventional groups. In the snare group, all LV leads were implanted safely using orthodromic (n = 15) or antidromic (n = 5) techniques, and no immediate complications occurred including vessel perforation, tamponade, and lead dislodgement. During follow-up, LV lead threshold and impedance remained stable without requiring lead revision in the snare group. There were no significant between-group differences regarding LV ejection fraction increase (12 ± 13% vs. 12 ± 13%, p = 0.929) and LV end-systolic volume reduction (18 ± 48% vs. 28 ± 31%, p = 0.501). Both groups exhibited comparable CRT-response rates (62.5% vs. 60.6%, p = 1.000). The risk of primary outcome was not significantly different between the two groups (25.9% vs. 30.9%, p = 0.817). In patients who failed conventional LV lead implantation for CRT, the snare technique could be a safe and effective solution to overcome difficult coronary venous anatomy.

Using Machine-Learning for Predictionofthe Response to CardiacResynchronization Therapy: TheSMART-AV Study.

This study aimed to apply machine learning (ML) to develop a prediction model for short-term cardiac resynchronization therapy (CRT) response to identifying CRT candidates for early multidisciplinary CRT heart failure (HF) care. Multidisciplinary optimization of cardiac resynchronization therapy (CRT) delivery can improve long-term CRT outcomes but requires substantial staff resources. Participants from the SMART-AV (SmartDelay-Determined AV Optimization: Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy [CRT]) trial (n=741; age: 66 ± 11 years; 33% female; 100% NewYork Heart Association HF functional class III-IV; 100% ejection fraction≤35%) were randomly split into training/testing (80%; n=593) and validation (20%; n=148) samples. Baseline clinical, electrocardiographic, echocardiographic, and biomarker characteristics, and left ventricular (LV) lead position (43 variables) were included in 8 ML models (random forests, convolutional neural network, lasso, adaptive lasso, plugin lasso, elastic net, ridge, and logistic regression). Acomposite of freedom from death and HF hospitalization and a >15% reduction in LV end-systolic volume index at 6months after CRT was the end point. The primary end point was met by 337 patients (45.5%). The adaptive lasso model was the most more accurate (area under the receiver operating characteristic curve: 0.759; 95% CI: 0.678-0.840), well calibrated, and parsimonious (19 predictors; nearly half potentially modifiable). Participants in the 5th quintile compared with those in the 1st quintile of the prediction model had 14-fold higher odds of composite CRT response (odds ratio: 14.0; 95%CI: 8.0-14.4). The model predicted CRT response with 70% accuracy, 70% sensitivity, and 70% specificity, and should be further validated in prospective studies. ML predicts short-term CRT response and thus may help with CRT procedure and early post-CRT careplanning. (SmartDelay-Determined AV Optimization: A Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy [CRT] [SMART-AV]; NCT00677014).

Abstract 13731: Randomized Trial of CMR Guidance for Cardiac Resynchronization Therapy: Findings in Nonischemic Cardiomyopathy From an Interim Analysis

Introduction: Cardiac resynchronization therapy (CRT) response rates in unselected cohorts are suboptimal. Cardiac magnetic resonance (CMR) provides high-quality imaging of strain and scar, and post-CRT CMR offers reliable assessment of left ventricular (LV) reverse remodeling. Hypothesis: Cardiac magnetic resonance (CMR) guidance for CRT will increase CRT response rates, particularly in nonischemic cardiomyopathy (NICM). Methods: Patients were randomized 1:1 to standard CRT or CMR guidance for CRT using circumferential strain from Displacement Encoding with Stimulated Echoes (DENSE) and scar (late gadolinium enhancement [LGE]) by CMR. The primary endpoint is the percent change in LV end-systolic volume (LVESV) calculated from CMRs before CRT and 6 months after CRT. A pre-specified interim analysis by cardiomyopathy type was performed after completion of enrollment of 45 of the projected 90 patients needed for adequate power. Results: Of 45 patients enrolled (age 65.9 +/- 10.3 years, 29% female), two patients did not undergo a CRT procedure, and the LV lead could not be placed in one patient. Of the remaining 42 patients, 26/42 had NICM and 21/42 were randomized to CMR guidance. In a linear regression model for the primary endpoint adjusted for baseline QRS duration (p=0.04) and cardiomyopathy type (p=0.01), a favorable trend for the intervention on response was noted (p=0.06). Box plots demonstrate a significant difference in the primary endpoint among NICM patients (p=0.03) and a favorable trend for QRS shortening (0.07) in NICM patients (Figure). In all patients (including ICM patients), the overall p-value for the intervention relative to the primary endpoint was 0.08. Conclusion: An interim analysis in CRT patients with NICM demonstrated a favorable effect of CMR guidance on LV reverse remodeling after CRT, as assessed with post-CRT CMRs. Enrollment is continuing to evaluate the effect of the intervention on the entire cohort and other endpoints.

Abstract 12414: 3D Fusion of MRI Mechanical Activation, Cardioinsight Electrical Activation, and Fluoroscopic Lead Location for CRT

Introduction: 3D image integration can help achieve personalized medicine for patients undergoing device therapy for heart failure, such as cardiac resynchronization therapy (CRT). Hypothesis: Electrical mapping data and mechanical activation from cardiac magnetic resonance (CMR) integrated with live fluoroscopic data will provide complementary information to optimize CRT procedures. Methods: Ten patients underwent cardiac CT and electrical mapping with the CardioInsight 252-electrode vest (Medtronic) during CRT implantation using a 3D-capable fluoroscopy system (Artis zeego, Siemens) and a 3D image integration software prototype (Guide-CRT, Siemens). A myocardial mechanical activation map based on strain from CMR Displacement Encoding with Stimulated Echoes (DENSE) and an electrical activation map from CardioInsight were fused with fluoroscopic images using Guide-CRT. Results: In a representative patient with LBBB and QRS duration 140 ms, integrated 3D maps of electrical and mechanical activation with the fluoroscopic lead location are shown for right/left anterior oblique (RAO/LAO) and anterior-posterior (AP) views (Figure). While the area of late mechanical activation is centered at about 3 o’clock on the mitral annulus, a slightly more anterolateral and smaller focus of late electrical activation is noted on the CardioInsight maps (Figure). Furthermore, more basal activation data is possible with the electrical maps, as strain imaging typically starts below the mitral valve. While a middle LV electrode (LV2-4) was chosen for CRT pacing based on the CMR map, the more proximal and anterolateral LV electrode could have been chosen based on the electrical map. Conclusions: Multimodality mapping and 3D fusion of mechanical activation, electrical activation, and lead position provide important information regarding electromechanical coupling and the choice of the optimal pacing location.

Diastolic dyssynchrony assessment by gated myocardial perfusion-SPECT in subjects who underwent cardiac resynchronization therapy

BackgroundLeft ventricular diastolic dyssynchrony (LVDD) can be assessed by gated myocardial perfusion single-photon emission computed tomography (GMP-SPECT). LVDD is an area of interest in subjects who underwent cardiac resynchronization therapy (CRT). The aim of this post hoc analysis was to assess the role of LVDD in subjects with CRT who were followed up at 6-month period. Material & MethodsLeft ventricular diastolic dyssynchrony was assessed by GMP-SPECT at baseline and after CRT procedure in 160 subjects from 10 different cardiological centers. CRT procedure was performed as per current guidelines. Outcomes were defined as improvement in ≥1 New York Heart Association (NYHA) class, left ventricular ejection fraction (LVEF) by 5%, and reduction in end-systolic volume (ESV) by 15% and 5% points in Minnesota Living with Heart Failure Questionnaire. LVDD was defined as diastolic phase standard deviation ≥40 ± 14°. ResultsImprovement in NYHA functional class occurred in 105 (65.6%), LVEF in 74 (46.3%), decrease in ESV in 86 (53.8%), and Minnesota score in 85 (53.1%) cases. Baseline LV diastolic standard deviation was 53.53° ± 20.85 and at follow-up 40.44° ± 26.1283; (P < 0.001). LVDD was not associated with improvement in clinical outcomes at follow-up. ConclusionCRT improves both systolic and diastolic dyssynchrony values at 6-month follow-up. LVDD at baseline is correlated with cardiac functionality at follow-up, but not with overall favorable clinical outcomes.

Using ensemble of ensemble machine learning methods to predict outcomes of cardiac resynchronization.

The efficacy of cardiac resynchronization therapy (CRT) has been widely studied in the medical literature; however, about 30% of candidates fail to respond to this treatment strategy. Smart computational approaches based on clinical data can help expose hidden patterns useful for identifying CRT responders. We retrospectively analyzed the electronic health records of 1664 patients who underwent CRT procedures from January 1, 2002 to December 31, 2017. An ensemble of ensemble (EoE) machine learning (ML) system composed of a supervised and an unsupervised ML layers was developed to generate a prediction model for CRT response. We compared the performance of EoE against traditional ML methods and the state-of-the-art convolutional neural network (CNN) model trained on raw electrocardiographic (ECG) waveforms. We observed that the models exhibited improvement in performance as more features were incrementally used for training. Using the most comprehensive set of predictors, the performance of the EoE model in terms of the area under the receiver operating characteristic curve and F1-score were 0.76 and 0.73, respectively. Direct application of the CNN model on the raw ECG waveforms did not generate promising results. The proposed CRT risk calculator effectively discriminates which heart failure (HF) patient is likely to respond to CRT significantly better than using clinical guidelines and traditional ML methods, thus suggesting that the tool can enhanced care management of HF patients by helping to identify high-risk patients.

Device infections related to cardiac resynchronization therapy in clinical practice–An analysis of its prevalence, risk factors and routine surveillance at a single center university hospital

BackgroundThe implantation rates of cardiac implantable electronic devices have steadily increased, accompanied by a steeper rise of device related infections (DRI).HypothesisThe prevalence of DRI for cardiac resynchronization therapy (CRT) is higher in clinical practice than reported previously, even at a university hospital, and likely higher than reported to the national device registry.MethodsElectronic medical records of consecutive patients undergoing a CRT procedure between January 2016 and December 2017 were analyzed. Clinical history, procedure related variables and complications were reviewed by specialists in cardiology and infectious diseases.ResultsA total of 171 patients, mean aged 74 years, 138 males (80.7%) were included. Twelve DRI occurred in 10 patients during mean 2.5 years follow‐up, giving a prevalence of 7% (incidence of 29/1000 person‐years). Reoperation, pocket haematoma, ≥3 procedures, previous device infection and indwelling central venous line were the strongest predictive factors according to univariate analysis. Out of 63/171 (36.8%) major complications, 31(49.2%) were lead‐related. There were 49/171 (28.7%) reoperations and 15/171 (8.8%) minor complications. The number major complications and DRI reported to the national device registry were 7/171 (4.1%) and 2/171 (0.6%), respectively, reflecting a 5‐fold underreporting.ConclusionsThe high rate of CRT device infections is in sharp contrast to those reported by others and to the national device registry. Although a center specific explanation cannot be excluded, the high rates highlight a major issue with registries, reinforcing the need for better surveillance and automatic reporting of device related complications.

Predictive value of post-implantation frontal QRS-T angle in patients receiving cardiac resynchronization therapy

Abstract Funding Acknowledgements Type of funding sources: None. Objective Favourable response criteria for cardiac resynchronization therapy (CRT) implantation are still under debate. We investigated the relationship between frontal QRS-Tangle and improvement of functional New York Heart Association (NYHA) class and thus favourable response to CRT. Method Eighty-one patients were included in the study who CRT implanted. ECG and echocardiography were obtained 1 week before and after six month-1 years the CRT procedure. Patients were classified as "NYHA improvement" and "NYHA non-improvement" according to their NYHA class. The frontal QRS-T angle was calculated the absolute value of the difference between the QRS and T wave axes [Frontal QRS-Tangle=(QRS axis-T axis)] Results The mean age of patients was 64.5 ± 9.1 years. There was no difference between two groups in terms of demographic features. The post-implantation LVEF was higher in patients NYHA improvement group (p &amp;lt; 0.001). Post–implantation QRS duration (p = 0.008), cQT interval (p = 0.012), frontal QRS-T angle (p = 0.003) values were very shorter in NYHA improvement group (Table 1). In multivariate regression analysis showed the frontal QRS-T angle and age independent risk factors for improvement of NYHA class (p &amp;lt; 0.05). The receiver operating characteristics curve analysis (ROC) were showed the optimal cut-off value of predicting NYHA improvement for frontal QRS-Tangle was &amp;lt; 135 (AUC:0.69, 95%CI 0.575-0.814, p = 0.004). Conclusion: We found that after CRT implantation, functional NYHA class improvement was associated the shortened of QRS, cQT interval, increased LVEF and narrowed of the frontal QRS-Tangle (&amp;lt;135 ms) was in both ischemic and non-ischemic patients Table 1 variables NYHA improvement group(43) NYHA non-improvement group (n = 34) p value age (years) 61.1 ± 9.9 66.5 ± 8.9 0.017 Post-implantation EF (%) 39 (30-50) 30 (20-37) &amp;lt;0.001 Pre-CRT Frontal QRS-T angle (º) 153.0 ± 57.8 155.7 ± 56.7 0.840 Post-CRT Frontal QRS-T angle (º) 118.4 ± 69.7 168.1 ± 67.8 0.003 Table 1

Clinical manifestations of device-related infective endocarditis in cardiac resynchronization therapy recipients.

IntroductionThe aim of the study was to analyse microbiological characteristics and clinical manifestations of cardiac device-related infective endocarditis (CDRIE) in cardiac resynchronization therapy (CRT) recipients, and to compare the diagnostic value of modified Duke (MDC) versus modified Duke lead criteria (MDLC; including to MDC local infection and pulmonary infection or embolism as major criteria).Material and methodsThe study population comprised 765 consecutive CRT patients from a high-volume, tertiary care centre from 2002 to 2015. All patients were screened for CDRIE.ResultsDuring a median follow-up of 1692 days (range: 457–3067) 5.36% of patients (n = 41) developed CDRIE, which was accompanied by CRT pocket infection in 17.1% (n = 7) and recurrent pulmonary infection or pulmonary embolism in 29.3% (n = 12). Fever was present in 95.1% of patients (n = 39), whereas blood cultures were positive in 65.9% (n = 27). Staphylococcus was the most prevalent pathogen in 59.3% (n = 16), Gram-negative bacteria in 25.9% (n = 7). Transoesophageal echocardiography showed intracardiac vegetations in 73.2% of patients (n = 30). Non-different pathogen types with the most common methicillin-sensitive Staphylococcus aureus were observed for early versus late CDRIE (endocarditis ≤ 6 vs. > 6 months from CRT or other device-related procedure). All 3 inflammatory markers (C-reactive protein, white blood cells, procalcitonin) were normal in 4.9% of patients (n = 2). MDC versus MDLC indicated definite CDRIE in 48.8% versus 80.5%, respectively (p = 0.003).ConclusionsFever is the most common symptom of CRT-related CDRIE, and transoesophageal echocardiography allows vegetations to be visualised in nearly 3/4 of patients with CDRIE. Although the most common pathogens were Staphylococci, Gram-negative bacteria accounted for a quarter of CDRIE. Modified Duke lead criteria proved superior to MDC.

Usefulness of Pre-Procedural Imaging of the Coronary Venous System With Coronary Angiography Before Cardiac Resynchronization Therapy.

Cardiac resynchronization therapy (CRT) is a treatment modality for selected patients with refractory heart failure. We intended to examine the usefulness of coronary venous system imagining with conventional coronary angiogram before the CRT implantation procedure. A total of 180 patients were scheduled for CRT and were prospectively randomized 1:2 into 2 groups. Group 1 (n = 60) received standard CRT procedure without the guidance of selective left coronary angiography. In group 2 (n = 120), CRT implantation was accomplished with the guidance of the preprocedural coronary angiography. We compared the 2 groups in terms of the total implantation time, total fluoroscopy time, the amount of contrast medium used, and cumulative radiation exposure. The total implantation and fluoroscopy times, the amount of contrast medium used, and cumulative radiation exposure were significantly less in group 2 compared with group 1 (53 ± 7 vs 66 ± 9 minutes, 11 ± 3 vs 20 ± 5 minutes, 24 ± 8 vs 42 ± 14 mL, 26 192 ± 6658 vs 37 388± 9064 mGy cm2, and 253 ± 49 vs 392 ± 79 mGy, P < .0001, respectively). We concluded that coronary angiography prior to CRT implantation is useful in simplifying the procedure, saving time, reducing radiation exposure, and reducing contrast use.

Comparison of de novo versus upgrade cardiac resynchronisation therapy on clinical effect and long-term outcome

Background The benefit of de novo cardiac resynchronisation therapy (CRT) implantation in selected patients with heart failure is well known. The number of upgrade procedures is increasing but data on clinical response and outcome are less well documented as compared to de novo implantation. Objectives To investigate the efficacy and outcome of CRT upgrade procedures in patients with existing cardiac implantable electronic devices (CIEDs). Methods Baseline characteristics, change in New York Heart Association (NYHA) functional class, echocardiographic parameters, life-threatening ventricular tachyarrhythmias, all-cause mortality and mode of death were evaluated in CRT patients with the comparison between de novo and upgrade CRT procedures. Results About 410 patients (CRT upgrade/de novo CRT, n = 97/313) were followed for 63.5 ± 38.1 months. Upgrade patients were older (75.5 ± 8.1 vs 69.9 ± 10.7 years; p < 0.001), had more often an ischaemic cause of heart failure (58.8% vs 45.4%; p = 0.021), a higher NYHA functional class (p = 0.004) and a higher comorbidity burden. Improvement in left ventricular ejection fraction (LVEF) was higher in the de novo CRT group (8.4 ± 9.9 vs 11.0 ± 10.3%; p = 0.035). Clinical response was similar between both groups (60.5 vs 62.5%; p = 0.793), as was mortality at 1 year (8.2 vs 5.8%; p = 0.351) and at last follow-up (33.0 vs 28.8%; p = 0.447). The proportion of cardiovascular related deaths was similar between both groups (46.9% vs 38.9%; p = 0.531). Conclusions Patients with CRT upgrade procedures have similar symptomatic improvements, as well as 1 year and long-term outcome as compared to patients with de novo CRT implantation.

Cardiac pacing procedures during coronavirus disease 2019 lockdown in Southern Italy: insights from Campania Region.

Aim of our study was to assess the association between COVID-19 lockdown and cardiac pacing (CP) procedures rates in Campania Region, the third-most-populous region of Italy with about 5.8 million residents. Data about type of CP procedures and unit admissions were obtained from 14 CP centers throughout Campania region from March 10th and May 4Th 2020 and compared with the same time frame in 2019. A remarkable reduction in both temporary (reduction rate: -62.5%), definitive pace maker (reduction rate: -30.2%), ICD (reduction rate: -48.3%) and CRT (reduction rate: -48.4%) implantation and in CRT replacement (reduction rate: -88.8%) procedures has been shown between the two observation periods among 951 hospitalized patients. Planned hospitalizations showed a reduction rate of 69.3%. Conversely, urgent intra-hospital admissions (increase rate +430%; P < 0.001) increased during COVID-19 lockdown and no significant difference in attendance rate to the emergency department (increase rate +6.7%; P = 0.254) has been shown. COVID-19 lockdown was associated with a remarkable decrease in CP procedures due to the reduction of planned hospitalizations in Campania Region; however, no significant difference in emergency department admission rate was shown.

Comparative Analysis of Procedural Outcomes and Complications Between De Novo and Upgraded Cardiac Resynchronization Therapy.

This study compared rates of procedural success and complications between de novo cardiac resynchronization therapy (CRT) implantation versus upgrade, including characterization of technical challenges. CRT upgrade is common, but data are limited on the incidence of procedural success and complications as compared to de novo implantation. All patients who underwent a transvenous CRT procedure at a single institution between 2013 and 2018 were reviewed for procedure outcome, 90-day complications, reasons for unsuccessful left ventricular lead delivery, and the presence of venous occlusive disease (VOD) that required a modified implantation technique. Among 1,496 patients, 947 (63%) underwent de novo implantation and 549 (37%) underwent device upgrade. Patients who received a device upgrade were older (70 ± 12 years vs. 68 ± 13 years; p<0.01), with a male predominance (75% vs. 66%; p<0.01) and greater prevalence of comorbidities. There was no difference in the rate of procedural success between de novo and upgrade CRT procedures (97% vs. 96%; p=0.28) or 90-day complications (5.1% vs. 4.6%; p=0.70). VOD was present in 23% of patients who received a device upgrade and was more common among patients with a dual-chamber versus a single-chamber device (26% vs. 9%; p<0.001). Patients with and without VOD had a similar composite outcome of procedural failure or complication (8.0% vs. 7.8%; p=1.0). Rates of procedural success and complications were no different between de novo CRT implantations and upgrades. VOD frequently increased procedural complexity in upgrades, but alternative management strategies resulted in similar outcomes. Routine venography before CRT upgrade may aid in procedural planning and execution of these strategies.

Remarkable response to cardiac resynchronization therapy via left bundle branch pacing in patients with true left bundle branch block.

BackgroundLeft bundle branch pacing (LBBP) has been suggested as an alternative means to deliver cardiac resynchronization therapy (CRT).HypothesisLBBP may deliver resynchronization therapy along with an advantage over traditional biventricular (BiV) pacing in clinical outcomes.MethodsHeart failure patients who presented LBBB morphology according to Strauss's criteria and received successful CRT procedure were enrolled in the present study. Propensity score matching was applied to match patients into LBBP‐CRT group and BiV‐CRT group. Then, the electrographic data, the echocardiographic data and New York heart association (NYHA) class were compared between the groups.ResultsTwenty‐one patients with successful LBBP procedure and another 21 matched patients with successful BiV‐CRT procedure were finally enrolled in the study. The QRS duration (QRSd) was narrowed from 167.7 ± 14.9 ms to 111.7 ± 12.3 ms (P < .0001) in the LBBP‐CRT group and from 163.6 ± 13.8 ms to 130.1 ± 14.0 ms (P < .0001) in the BiV‐CRT group. A trend toward better left ventricular ejection fraction (LVEF) was recorded in the LBBP‐CRT group (50.9 ± 10.7% vs 44.4 ± 13.3%, P = .12) compared to that in the BiV‐CRT group at the 6‐month follow‐up. A trend toward better echocardiographic response was documented in patients receiving LBBP‐CRT procedure (90.5% vs 80.9%, P = .43) and more super CRT response was documented in the LBBP‐CRT group (80.9% vs 57.1%, P = .09) compared to that in the BiV‐CRT group.ConclusionsLBBP‐CRT can dramatically improve the electrical synchrony in heart failure patients with LBBB. Meanwhile, compared with the traditional BiV‐CRT, it has a tendency to significantly improve LVEF and enhance the NYHA cardiac function scores.

Impact of diabetes on clinical outcome of patients with heart failure undergoing ICD and CRT procedures: results from the German Device Registry.

AimsDiabetes mellitus (DM) has a negative impact on prognosis in patients with heart failure (HF). The role impact of DM in HF patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) devices might differ and remains unclear. The aim of our study was to investigate the impact of DM on periprocedural complications and clinical outcome in HF patients undergoing ICD or CRT implantation.Methods and resultsWithin the German Device Registry, data from 50 German centres were collected between January 2007 and February 2014. A retrospective analysis of n = 5329 patients undergoing ICD implantation was conducted. Patients' characteristics, procedural data, periprocedural complications, and post‐procedural clinical outcome, including a composite clinical endpoint of all‐cause mortality, stroke, and myocardial infarction (MACCE), were analysed. Subgroup analysis were performed for ICD and CRT implantations. Median follow‐up was 15.7 (12.9; 20.0) and 16.2 (12.8; 21.2) months in DM and non‐DM patients. Of 5329 patients enrolled, n = 1448 (27.2%) had a diagnosis of DM. Within the cohort, 94% of DM and 90% of non‐DM patients had a diagnosis of HF. Patients with DM were older, had higher body mass index, and higher rate of cardiovascular comorbidities compared with non‐DM patients. Unadjusted and adjusted analyses revealed similar all‐over intrahospital periprocedural complication rates in both groups (4.1% vs 3.9%). Unadjusted Kaplan–Meier survival analysis showed higher all‐cause mortality after 1 year (9.0% vs 6.3%; log‐rank P = 0.001) with higher MACCE rates (10.0% vs 7.3%; P < 0.001) in the DM group versus non‐DM patients. After multivariable adjustment for relevant covariates, the association of DM to MACCE disappeared [HR 1.11 (0.89‐1.38)]. Because chronic kidney disease (CKD) was clearly associated with increased 1 year MACCE after multivariate adjustment [odds ratio (OR) 2.11 (1.68–2.64)], a subgroup analysis was performed showing a strong trend towards more perioperative complications in DM patients with CKD [OR 2.16 (0.9–5.21)], while no effect of DM was observed in patients without CKD [OR 0.73 (0.42–1.28)].ConclusionsThe overall risk of periprocedural complications and short‐term (1 year) clinical outcome in patients with DM and HF undergoing ICD or CRT defibrillator (CRT‐D) implantation was not increased. In contrast, CKD was associated with an increased risk of 1 year MACCE in HF patients undergoing ICD/CRT‐D implantation.

Can machine learning improve patient selection for cardiac resynchronization therapy?

RationaleMultiple clinical trials support the effectiveness of cardiac resynchronization therapy (CRT); however, optimal patient selection remains challenging due to substantial treatment heterogeneity among patients who meet the clinical practice guidelines.ObjectiveTo apply machine learning to create an algorithm that predicts CRT outcome using electronic health record (EHR) data avaible before the procedure.Methods and resultsWe applied machine learning and natural language processing to the EHR of 990 patients who received CRT at two academic hospitals between 2004–2015. The primary outcome was reduced CRT benefit, defined as <0% improvement in left ventricular ejection fraction (LVEF) 6–18 months post-procedure or death by 18 months. Data regarding demographics, laboratory values, medications, clinical characteristics, and past health services utilization were extracted from the EHR available before the CRT procedure. Bigrams (i.e., two-word sequences) were also extracted from the clinical notes using natural language processing. Patients accrued on average 75 clinical notes (SD, 29) before the procedure including data not captured anywhere else in the EHR. A machine learning model was built using 80% of the patient sample (training and validation dataset), and tested on a held-out 20% patient sample (test dataset). Among 990 patients receiving CRT the mean age was 71.6 (SD, 11.8), 78.1% were male, 87.2% non-Hispanic white, and the mean baseline LVEF was 24.8% (SD, 7.69). Out of 990 patients, 403 (40.7%) were identified as having a reduced benefit from the CRT device (<0% LVEF improvement in 25.2%, death by 18 months in 15.6%). The final model identified 26% of these patients at a positive predictive value of 79% (model performance: Fβ (β = 0.1): 77%; recall 0.26; precision 0.79; accuracy 0.65).ConclusionsA machine learning model that leveraged readily available EHR data and clinical notes identified a subset of CRT patients who may not benefit from CRT before the procedure.