Comparison between IEGM-based approach and echocardiography in AV/PV and VV delay optimization in CRT-D recipients (Quicksept study).

BACKGROUND: AtrioVentricular (AV) and InterVentricular (VV) delay optimization can improve ventricular function in Cardiac Resynchronization Therapy (CRT) and is usually performed by means of echocardiography. St Jude Medical has developed an automated algorhythm which calculates the optimal AV and VV delays (QuickOpt™) based on Intracardiac ElectroGrams, (IEGM), within 2 min. So far, the efficacy of the algorhythm has been tested acutely with standard lead position at right ventricular (RV) apex. Aim of this project is to evaluate the algorhythm performance in the mid- and long-term with RV lead located in mid-septum. METHODS: AV and VV delays optimization data were collected in 13 centers using both echocardiographic and QuickOpt™ guidance in CRTD implanted patients provided with this algorhythm. Measurements of the aortic Velocity Time Integral (aVTI) were performed with both methods in a random order at pre-discharge, 6-month and 12-month follow-up. RESULTS: Fifty-three patients were studied (46 males; age 68 ± 10y; EF 28 ± 7%). Maximum aVTI obtained by echocardiography at different AV delays, were compared with aVTI acquired at AV delays suggested by QuickOpt. The AV Pearson correlations were 0.96 at pre-discharge, 0.95 and 0,98 at 6- and 12- month follow-up respectively. After programming optimal AV, the same approach was used to compare echocardiographic aVTI with aVTI corresponding to the VV values provided by QuickOpt. The VV Pearson Correlation were 0,92 at pre-discharge, 0,88 and 0.90 at 6-month and 12- month follow-up respectively. CONCLUSIONS: IEGM-based optimization provides comparable results with echocardiographic method (maximum aVTI) used as reference with mid-septum RV lead location.

"Shift and cover technique": conservative management of complications for the rescue of S-ICD subcutaneous implantable defibrillator systems.

BACKGROUND: The risk of complications has been shown to be lower with subcutaneous implantable defibrillator (S-ICD) than with conventional ICDs. Given the low frequency of complications, experience of how to manage them is limited. In this paper, we describe generator- and lead-related complications recorded in a series of S-ICD patients, and we propose our conservative approach to managing them. METHODS: The study cohort consisted of S-ICD patients who were referred to our institution owing to generator- or lead-related complications requiring surgical intervention. With our "shift and cover" approach, the system component involved is moved from its original position to an alternative, more protected location. In the case of the generator, this involves moving it to an intermuscular pocket. In the case of infections at the parasternal scar, the electrode sleeve is moved away from its original location, stitched, and then covered with the muscular fascia. RESULTS: Fourteen S-ICD patients were referred to our institution owing to system-related complications. Complications involved the generator in 7 cases (deep pocket infections with erosion, extrusion, or pain), the lead in 5 cases (parasternal infections at the xyphoid incision site), and both the generator and the lead in 2 cases. Complications were managed without completely removing the device and resolved in a single surgical session with no intraoperative complications. During defibrillation testing, the first shock at 65 J was effective in all patients. The shock impedance after revision was significantly lower than that measured during first implantation (59 ± 10 Ohm versus 86 ± 24 Ohm, P = 0.013). In all cases, the cosmetic result was satisfactory. No complications or recurrent infections were reported at the 12-month follow-up visit. CONCLUSIONS: The proposed conservative approach was successful in managing S-ICD complications. The revision procedure allowed to optimize the system configuration in terms of the defibrillation vector, resulting in lower shock impedance values and better device positioning.

Effective nonapical left ventricular pacing with quadripolar leads for cardiac resynchronization therapy.

BACKGROUND: Current guidelines recommend avoiding apical left ventricular (LV) pacing for cardiac resynchronization therapy (CRT). AIMS: We investigated the feasibility of nonapical pacing with the current quadripolar LV lead technology. METHODS: We analyzed consecutive patients who received CRT with an LV quadripolar lead. The post--implantation position of each electrode of the LV lead was designated as basal, mid, or apical. The pacing capture threshold (PCT) and phrenic nerve stimulation (PNS) threshold were assessed for each electrode. RESULTS: We enrolled 168 patients. A total of 8 CRT defibrillators were from Biotronik (with Sentus OTW QP leads), 98 were from Boston Scientific (with 21 Acuity X4 Spiral and 77 Acuity X4 Straight leads), and 62 from St. Jude Medical (with Quartet leads). The median (interquartile range) number of electrodes at nonapical segments per patient was 3 (1-4) with Biotronik Sentus leads, 4 (3-4) with spiral -design Boston Scientific leads, 4 (3-4) with straight Boston Scientific leads, and 3 (3-4) with St. Jude Medical Quartet leads (P = 0.045). Three patients (38%) with Biotronik Sentus leads, 21 (100%) with spiral -design Boston Scientific leads, 69 (90%) with straight -design Boston Scientific leads, and 49 (79%) with St. Jude Medical Quartet leads (P <0.001) had at least 1 electrode located at nonapical segments linked with a PNS -PCT safety margin of more than 2 V. During the 6-month follow -up, PNS was detected in 4 patients and was eliminated with reprogramming. No significant changes in PCT were detected during follow -up. CONCLUSIONS: Quadripolar leads allowed nonapical pacing with acceptable electrical parameters in the majority of CRT recipients, although differences were found among the currently available devices.

Does the Age Affect the Outcomes of Cardiac Resynchronization Therapy in Elderly Patients?

BACKGROUND: More and more heart failure (HF) patients aged ≥ 75 years undergo cardiac resynchronization therapy (CRT) device implantation, however the data regarding the outcomes and their predictors are scant. We investigated the mid- to long-term outcomes and their predictors in CRT patients aged ≥ 75 years. METHODS: Patients in the Cardiac Resynchronization Therapy Modular (CRT MORE) Registry were divided into three age-groups: <65 (group A), 65-74 (group B) and ≥75 years (group C). Mortality, hospitalization, and composite event rate were evaluated at 1 year and during long-term follow-up. RESULTS: Patients (n = 934) were distributed as follows: group A 242; group B 347; group C 345. On 12-month follow-up examination, 63% of patients ≥ 75 years displayed a positive clinical response. Mortality was significantly higher in patients ≥ 75 years than in the other two groups, although the rate of hospitalizations for HF worsening was similar to that of patients aged 65-74 (7 vs. 9.5%, respectively; p = 0.15). Independent predictors of death and of negative clinical response were age >80 years, chronic obstructive pulmonary disease (COPD) and chronic kidney disease (CKD). Over long-term follow-up (1020 days (IQR 680-1362)) mortality was higher in patients ≥ 75 years than in the other two groups. Hospitalization and composite event rates were similar in patients ≥ 75 years and those aged 65-74 (9 vs. 11.8%; p = 0.26, and 26.7 vs. 20.5%; p = 0.06). CONCLUSION: Positive clinical response and hospitalization rates do not differ between CRT recipients ≥ 75 years and those aged 65-74. However, age > 80 years, COPD and CKD are predictors of worse outcomes.

Adherence to 2016 European Society of Cardiology guidelines predicts outcome in a large real-world population of heart failure patients requiring cardiac resynchronization therapy.

BACKGROUND: Professional guidelines are based on the best available evidence. However, patients treated in clinical practice may differ from those included in reference trials. OBJECTIVE: The aim of this study was to evaluate the effects of cardiac resynchronization therapy (CRT) in a large population of patients implanted with a CRT device stratified in accordance with the 2016 European heart failure (HF) guidelines. METHODS: We collected data on 930 consecutive patients from the Cardiac Resynchronization Therapy MOdular REgistry. The primary end point was a composite of death and HF hospitalization. RESULTS: Five hundred sixty-three (60.5%) patients met class I indications, 145 (15.6%) class IIa, 108 (11.6%) class IIb, and 114 (12.3%) class III. After a median follow-up of 1001 days, 120 (14.7%) patients who had an indication to CRT had died and 71 (8.7%) had been hospitalized for HF. The time to the end point was longer in patients with a class I indication (hazard ratio 0.55; 95% confidence interval 0.39-0.76; P = .0001). After 12 months, left ventricular (LV) end-systolic volume had decreased by ≥15% in 61.5% (320/520) of patients whereas in 57.5% (389/676) of patients the absolute LV ejection fraction improvement was ≥5%. Adherence to class I was also associated with an absolute LV ejection fraction increase of >5% (P = .0142) and an LV end-systolic volume decrease of ≥15% (P = .0055). CONCLUSION: In our population, ∼60% of patients underwent implantation according to the 2016 European HF guidelines class I indication. Adherence to class I was associated with a lower death and HF hospitalization rates and better LV reverse remodeling.

The stricter criteria for Class I CRT indication suggested by the 2016 ESC Guidelines reliably exclude patients with a worse prognosis in comparison with the 2013 ESC indication criteria.

BACKGROUND: The European Society of Cardiology (ESC) Guidelines published in 2016 modified indications for cardiac resynchronization therapy (CRT) in comparison with the 2013 ESC Guidelines. The aim of this analysis was to evaluate the impact of the stricter criteria suggested by the 2016 ESC Guidelines on patient outcome in a real-world population. METHODS: We collected data on 930 consecutive patients with complete outcome information who had undergone CRT implantation from 2011 to 2013 from the CRT-MORE registry. Patients were classified according to 2013 (Reference) and 2016 (Current) ESC Guidelines. The primary end-point of the study was death from any cause and heart failure hospitalization. RESULTS: According to the Reference Guidelines, 650 (69.9%) patients met Class I indications, 190 (20.4%) Class IIa, 39 (4.2%) Class IIb and 51 (5.5%) Class III. According to the Current Guidelines, 563 (60.5%) patients met Class I indications, 145 (15.6%) Class IIa, 108 (11.6%) Class IIb and 114 (12.3%) Class III. On comparing the Reference and Current Guidelines, the 538 patients who confirmed their Class I indication had a better outcome in terms of freedom from the combined end-point of heart failure (HF) hospitalization or death from any cause (hazard ratio (HR) of 0.64; 95% CI 0.42 to 0.99; p = 0.0436) when compared to the 112 patients who lost their class I indication (84 moved to class IIb and 28 moved to class III). CONCLUSIONS: The stricter criteria for Class I CRT indication suggested by the 2016 ESC Guidelines excluded about 20% of patients with a worse prognosis. CLINICAL TRIAL REGISTRATION: CRT MORE: Cardiac Resynchronization Therapy Modular Registry URL: http://clinicaltrials.gov/Identifier:NCT01573091.