Optimization of coronary sinus lead placement targeted to right-to-left delay in patients undergoing cardiac resynchronization therapy.

AIMS: Anatomical placement of the coronary sinus (CS) lead in basal or mid-ventricular positions of the posterior and lateral walls is associated with a better clinical outcome of cardiac resynchronization therapy (CRT). We hypothesized that optimization of CS lead placement targeted the right-to-left electrical delay (RLD) predicts an additional clinical benefit. METHODS AND RESULTS: The CS lead was placed according to current standards in 90 patients (Conventional group) and at the site of the longest RLD in 121 patients (RLD group). Non-responders were defined as those who died or underwent hospitalization for heart failure or did not improve in their Clinical Composite Score within 6 months. There were 67 (32%) non-responders. Compared with Conventional group, the final CS pacing site was more frequently in the basal segments in the RLD group (40% vs. 23%, P = 0.007); moreover, the RLD ratio (%RLD) of the total QRS width was longer (77 ± 13 vs. 73 ± 15, P = 0.05) and biventricular QRS shortened more from the baseline (-31 ± 21 ms vs. -21 ± 26 ms, P = 0.004). Nevertheless, the rate of non-responders was similar in the RLD and Conventional groups (35% vs. 28%, P = 0.30), as was %RLD (76 ± 16 vs. 75 ± 13, P = 0.66). QRS width during right ventricular (RV) pacing was an independent predictors of adverse outcome, with a 2% increase in the risk of failure for each 1 ms increase in QRS (P = 0.006). CONCLUSION: Optimization of CS lead placement targeted to latest electrical activation does not provide additional clinical benefit to anatomical placement in basal or mid-ventricular positions of the posterior and lateral walls. QRS width during RV pacing was a strong predictor of CRT failure. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT03204864.

Optimization of coronary sinus lead placement targeted to the longest right-to-left delay in patients undergoing cardiac resynchronization therapy: The Optimal Pacing SITE 2 (OPSITE 2) acute study and protocol.

AIMS: Left ventricular (LV) lead positioning at the site of delayed electrical activation is associated with better response to cardiac resynchronization therapy (CRT). We hypothesized that a long electrical conduction delay between right ventricular (RV) and coronary sinus (CS) leads during RV pacing (RLD index) is correlated with a better clinical outcome METHODS AND RESULTS: RLD is measured intraprocedurally, during RV pacing, as the time interval between the intracardiac electrograms of RV and CS leads. Initially, we did a prove-of-concept, feasibility, acute study in 97 patients who underwent CRT implantation. The CS lead position was assessed in the 40° right anterior oblique and 40° left anterior oblique views and assigned to one of 11 prespecified segments of a schematic eyeball depiction of the LV walls. Acute outcomes were QRS width during biventricular (BIV) pacing. The longest RLD were found in the basal and mid lateral segments; these accounted for 82% and 78%, respectively, of the total QRS width (%RLD). %RLD was inversely correlated with BIV-paced QRS (P  =  0.0001). A similar slope was present either in the 78 patients with preserved atrioventricular (AV) conduction and in the 19 without AV conduction (- 0.34 vs - 0.27, P  =  0.7). CONCLUSION: We showed that RLD can be used to guide lead placement at the time of CRT implantation and that it is correlated with BIV-QRS width, an indirect predictor of clinical outcome. Based on these findings we started the prospective, multicenter Optimal Pacing SITE 2 (OPSITE 2) trial with the objective to demonstrate a relationship between RLD and clinical outcomes assessed as death, hospitalization for heart failure, New York Heart Association class, and clinical composite score. The protocol is provided.

Automatic atrial capture device control in real-life practice: A multicenter experience.

BACKGROUND: Device-based fully automatic pacing capture detection is useful in clinical practice and important in the era of remote care management. The main objective of this study was to verify the effectiveness of the new ACAP Confirm® algorithm in managing atrial capture in the medium term in comparison with early post-implantation testing. METHODS: Data were collected from 318 patients (66% male; mean age, 73±10 years); 237 of these patients underwent device implantation and 81 box changes in 31 Italian hospitals. Atrial threshold measurements were taken manually and automatically at different pulse widths before discharge and during follow-up (7±2 months) examination. RESULTS: The algorithm worked as expected in 73% of cases, considering all performed tests. The success rate was 65% and 88% pre-discharge and during follow-up examination (p<0.001), respectively, in patients who had undergone implantation. We did not detect any difference in the performance of the algorithm as a result of the type of atrial lead used. The success rate was 70% during pre-discharge testing in patients undergoing device replacement. Considering all examination types, manual and automatic measurements yielded threshold values of 1.07±0.47 V and 1.03±0.47 V at 0.2-ms pulse duration (p=0.37); 0.66±0.37 V and 0.67±0.36 V at 0.4 ms (p=0.42); and 0.5±0.28 V and 0.5±0.29 V at 1 ms (p=0.32). CONCLUSIONS: The results show that the algorithm works before discharge, and its reliability increases over the medium term. The algorithm also proved accurate in detecting the atrial threshold automatically. The possibility of activating it does not seem to be influenced by the lead type used, but by the time from implantation.

New heparinizable modified poly(carbonate urethane) surfaces diminishing bacterial colonization.

Percutaneous devices are extensively used in modern medicine therapies, even in long term applications. Complications from their use, related to bacterial colonization and/or to materials thrombogenicity, may result in a significant morbidity and mortality incidence. In this study, a novel polycarbonate-urethane (PCU), incorporating a tailor-made diamino-diamide-diol (PIME) showing the ability to bind heparin at physiological pH, was compared to commercial medical-grade PCUs (Carbothane and Bionate). Mechanical and thermal properties were evaluated by tensile tests, dynamic mechanical analysis and differential scanning calorimetry. The presence of a low amount of PIME chain extender in Bionate polyurethanes (Bionate-PIME) slightly affects the mechanical properties, remaining however comparable with the medical grade PCUs used for the fabrication of cardiovascular devices. To verify thereof heparin surface adsorbed in disfavouring bacterial colonization, heparinized Bionate-PIME was tested for bacterial adhesion, using Bionate and Carbothane as reference. In vitro bacterial interaction tests were performed with the strains mainly involved in the pathogenesis of device-related infections (S. epidermidis and S. aureus). MTT tests and SEM observations showed a decrease in colonization of the different strains on the heparinized Bionate-PIME surfaces, confirming that preadsorbed heparin plays a role in mediating the biomaterial surface/bacterial cells interactions.