Pulmonary fluid overload monitoring in heart failure patients with single and dual chamber defibrillators.

AIMS: Heart failure has a relevant healthcare impact. Monitoring of pulmonary fluid overload (PFO), measured by intrathoracic impedance, has been proposed to alert to heart failure worsening before symptoms become patent. The aim of our research was to evaluate whether PFO diagnostics reduce heart failure hospitalizations in heart failure patients receiving single-chamber or dual-chamber implantable cardioverter-defibrillator (ICD) for primary prevention of sudden death. METHODS: Twenty-five Italian cardiological centers prospectively followed 221 ICD patients (86% men, 66 ±â€Š11 years, 79% New York Heart Association II and left ventricular ejection fraction 28 ±â€Š5%), of whom 123 received an ICD with PFO monitoring (diagnostics group) and 98 an ICD without such a diagnostics (control group). The association of each patient to a group was assigned a priori, independently of patients' characteristics but based on regional device allocation policies. RESULTS: Patient clinical characteristics and observation period were similar between groups. In a mean follow-up of 17 ±â€Š11 months, heart failure hospitalizations or emergency-room admissions occurred in eight (7%) patients of the diagnostics group and in 16 of the control group (16%; P = 0.02), with an incidence, measured by Kaplan-Meier analysis, of 23% at 2 years and 34% at 3 years in patients of the control group compared with 8% at 2 and 3 years in patients of the diagnostics group (Log rank test P = 0.044). CONCLUSION: Our data show that in heart failure patients receiving single-chamber or dual-chamber ICD, the use of intrathoracic impedance monitoring is associated with a significant reduction of heart failure hospitalizations. Our results support the hypothesis that PFO diagnostics improve the likelihood of timely detection of heart failure worsening.

Short-spaced dipole for managing phrenic nerve stimulation in patients with CRT: the "phrenic nerve mapping and stimulation EP" catheter study.

BACKGROUND: Phrenic nerve stimulation (PNS), occurring in 33%-37% of the patients with cardiac resynchronization therapy (CRT), is a limiting factor when implanting left ventricular (LV) leads from coronary veins. OBJECTIVE: To test the hypothesis that PNS occurrence is related to bipolar electrode spacing. METHODS: During standard CRT defibrillator implant procedures, a 5-F diagnostic electrophysiology catheter with 10 electrodes, spaced 2-5-2 mm, was positioned in a cardiac vein suitable for permanent LV lead placement. Pacing in the unipolar configuration identified the site with the lowest PNS threshold. PNS and left ventricular pacing (LVP) thresholds were then measured in different configurations at 0.5 ms: unipolar, each LV electrode served as the cathode in turn; and bipolar with different electrode spacing, cathode being the electrode with the lowest unipolar PNS threshold. RESULTS: From February to September 2010, 40 patients undergoing CRT implantation were enrolled in 4 centers in Italy. It was possible to identify PNS and perform a complete set of measurements in 23 patients. A bipolar electrode spacing of 2 mm resulted in higher PNS thresholds in bipolar configurations han did a bipolar electrode spacing of ≥ 5 mm. However, no significant increase in the LVP threshold was observed (P = ns). CONCLUSIONS: This experience suggests that LVP with a bipolar electrode spacing of 2 mm significantly increases the PNS threshold without affecting the LVP threshold, thereby increasing the possibility of delivering CRT when the LV lead is placed in proximity to the phrenic nerve.

Permanent His-bundle pacing maintains long-term ventricular synchrony and left ventricular performance, unlike conventional right ventricular apical pacing.

AIMS: Right ventricular apical pacing (RVAP) may be deleterious, determining abnormal left ventricular (LV) electrical activation and progressive LV dysfunction. Permanent His-bundle pacing (HBP) has been proposed to prevent this detrimental effect. The aim of our study was to compare the long-term effects of HBP on LV synchrony and systolic performance with those of RVAP in the same group of patients. METHODS: Our analysis included 26 patients who received both an HBP lead and an RVAP lead, as backup, in our electrophysiology laboratory between 2004 and 2007. After implantation, all devices were programmed to obtain HBP. An intra-patient comparison of the effects of HBP and RVAP on LV dyssynchrony and function was performed at the last available follow-up examination. RESULTS: After a mean of 34.6 ± 11 months, the pacing modality was temporarily switched to RVAP. During RVAP, LV ejection fraction significantly decreased (50.1 ± 8.8% vs. 57.3 ± 8.5%, P < 0.001), mitral regurgitation significantly increased (22.5 ± 10.9% vs.16.3 ± 12.4%; P = 0.018), and inter-ventricular delay significantly worsened (33.4 ± 19.5 ms vs. 7.1 ± 4.7 ms, P = 0.003) in comparison with HBP. However, the myocardial performance index was not statistically different between the two pacing modalities (P = 0.779). No asynchrony was revealed by tissue Doppler imaging during HBP, while during RVAP the asynchrony index was significantly higher in both the four-chamber (125.8 ± 63.9 ms; P = 0.035 vs. HBP) and two-chamber (126 ± 86.5 ms; P = 0.037 vs. HBP) apical views. CONCLUSION: His-bundle pacing has long-term positive effects on inter- and intra-ventricular synchrony and ventricular contractile performance in comparison with RVAP. It prevents asynchronous pacing-induced LV ejection fraction depression and mitral regurgitation.

Effect of bipolar electrode spacing on phrenic nerve stimulation and left ventricular pacing thresholds: an acute canine study.

BACKGROUND: Phrenic nerve stimulation (PNS) is a common complication of cardiac resynchronization therapy when left ventricular (LV) pacing occurs via a coronary vein. The purpose of this study was to evaluate the effects of bipolar electrode spacing on PNS and LV pacing thresholds. METHODS AND RESULTS: Electrophysiology catheters with standard (2 mm-5 mm-2 mm) or modified (1 mm-5 mm-1 mm) interelectrode spacing was, respectively, inserted in a posterior/lateral cardiac vein in a randomized order in 6 anesthetized dogs via jugular access. The phrenic nerve was dissected via a left minithoracotomy and repositioned over the vein as close as possible to one of the electrodes. The presence of PNS was verified (ie, PNS threshold <2 V at 0.5 ms in unipolar configuration). Bipolar pacing was delivered using the electrode closest to the phrenic nerve as the cathode, and multiple bipolar electrode spacing configurations were tested. During bipolar pacing, PNS threshold increased as bipolar electrode spacing was reduced (P<0.05), whereas LV pacing thresholds did not change significantly (P>0.05). Compared with a standard bipolar electrode spacing of 20 mm for LV leads, 1 and 2 mm bipolar electrode spacing resulted in a PNS threshold increase of 5.5±2.2 V (P=0.003) and 2.8±1.7 V (P<0.001), respectively. Similarly, PNS threshold increased by 6.5±3.7 V with 1 mm and by 3.8±1.9 V with 2 mm bipolar pacing (both P<0.001), compared with unipolar pacing. CONCLUSIONS: This study suggests that reducing LV bipolar electrode spacing from the standard 20 mm to 1 or 2 mm may significantly increase the PNS threshold without compromising LV pacing thresholds.

Safety and performance of a system specifically designed for selective site pacing.

INTRODUCTION: In the right ventricle, selective site pacing (SSP) has been shown to avoid detrimental hemodynamic effects induced by right ventricular apical pacing and, in the right atrium, to prevent the onset of atrial fibrillation and to slow down disease progression. The purpose of our multicenter observational study was to describe the use of a transvenous 4-French catheter-delivered lead for SSP in the clinical practice of a large number of centers. METHODS: We enrolled 574 patients in whom an implantable device was indicated. In all patients, SSP was achieved by using the Select Secure System™ (Medtronic Inc., Minneapolis, MN, USA). RESULTS: In 570 patients, the lead was successfully implanted. In 125 patients, atrial SSP was performed: in 75 (60%) the lead was placed in the interatrial septum, in 31 (25%) in the coronary sinus ostium, and in 19 (15%) in the Bachman bundle. Ventricular SSP was undertaken in 138 patients: in 105 (76%) the high septal right ventricular outflow tract (RVOT) position was paced, in seven (5%) the high free-wall RVOT, in 25 (18%) the low septal RVOT, and in one (1%) the low free-wall RVOT. In the remaining 307 patients, the His zone was paced: in 87 (28%) patients, direct His-bundle pacing and in 220 (72%) patients para-hisian pacing was achieved. Adequate pacing parameters and a lead-related complication rate of 2.6% were recorded during a follow-up of 20 ± 10 months. CONCLUSIONS: Our results demonstrated that many sites, in the right atrium, in the right ventricle, and in His-bundle region, can be paced using the Select Secure System™.

Physiopathologic correlates of intrathoracic impedance in chronic heart failure patients.

BACKGROUND: Increased plasma levels of amino-terminal fraction of brain natriuretic peptide (NT-proBNP) and alterations of diastolic filling as described by Doppler transmitral flow pattern are well-known markers of decompensated heart failure (HF). Recently, some implantable defibrillators have allowed monitoring of intrathoracic impedance, which is related to lung water content, potentially indicating HF deterioration. The aim of this study was to assess the correlation between intrathoracic impedance and NT-proBNP and echo-Doppler transmitral flow indexes. METHODS: Data were collected from 111 HF patients, in six Italian centers. All patients were on optimal medical therapy. Device diagnostics, echographic data, NT-proBNP determination, and clinical status as assessed by the Heart Failure Score (HFS) were registered at baseline, at bimonthly visits, and at unscheduled examinations due to HF decompensation or device alerts. RESULTS: Over a median follow-up of 413 days, 955 examinations were performed. Intrathoracic impedance was significantly correlated with NT-proBNP (P = 0.013) and with mitral E-wave deceleration time (DtE) (P = 0.017), but not with HFS. At the time of confirmed alert events, NT-proBNP was significantly higher than during confirmed nonalert event examinations; DtE did not differ, whereas impedance was significantly lower. CONCLUSION: A decrease in intrathoracic impedance is inversely correlated with NT-proBNP and directly correlated with DtE. Intrathoracic impedance monitoring therefore has the physiologic basis for being a useful tool to identify early HF decompensation.

Intrathoracic and ventricular impedances are associated with changes in ventricular volume in patients receiving defibrillators for CRT.

BACKGROUND: Some implantable cardioverter defibrillators (ICD) are able to monitor intrathoracic impedance to detect pulmonary fluid overload. This is achieved by measuring impedance between the ICD case and the right ventricular (RV) lead. We hypothesized that the measured impedance would rise with improvement in left ventricular (LV) volumes during cardiac resynchronization therapy (CRT), and that such impedance changes would be more apparent when measured with an alternative pacing vector. METHODS: We analyzed echocardiographic and impedance data from heart failure patients implanted with a CRT-ICD capable of intrathoracic impedance measurement for fluid accumulation diagnosis, and LV pacing impedance recording for lead integrity monitoring. RESULTS: In 127 out of 170 patients that received de novo CRT implantation, the LV end-systolic volume (LVESV) decreased at 6-month follow-up (LVESV at 6 month-LVESV at baseline <0: group A). For the remaining 43 patients (group B) the change was > or = 0. Despite comparable values at baseline (P = 0.262), the impedances of groups A and B gradually diverged soon after the implant, resulting in significant difference between the two groups at the 6-month visit (P = 0.001). The changes in LV dimensions produced larger differences between groups in the impedance measured between the LV and the RV leads (P < 0.001). The regression analysis demonstrated an inverse correlation between paired changes of volume and intrathoracic impedance. Higher correlation coefficient was obtained using the LV-to-RV measurement vector (r =-0.635, P < 0.001). CONCLUSIONS: The changes in ICD-measured impedance seem associated with the LV volume changes induced by CRT. Specifically, the LV-to-RV impedance estimations seem to better correlate with paired changes of ventricular volumes.

Monitoring intrathoracic impedance with an implantable defibrillator reduces hospitalizations in patients with heart failure.

PURPOSE: Some implantable cardioverter-defibrillators (ICDs) are now able to monitor intrathoracic impedance. The aim of the study was to describe the use of such monitoring in clinical practice and to evaluate the clinical impact of the fluid accumulation alert feature of these ICDs. METHODS AND RESULTS: Five hundred thirty-two heart failure (HF) patients implanted with these ICDs were followed up for 11 +/- 7 months. A clinical event (CE) was deemed to have occurred if it resulted in hospitalization or milder manifestations of HF deterioration. Three hundred sixty-two acute decreases in intrathoracic impedance (Z events) occurred in 230 patients. Of these episodes, 171 (47%) were associated with a CE within 2 weeks of the Z event. In another 71 (20%) Z events, drug therapy was adjusted despite the absence of overt signs of clinical deterioration. The rate of unexplained Z events was 0.25 per patient-year and 25 hospitalizations were not associated with Z events. The audible alert was disabled in a group of 102 patients (OFF group). HF hospitalizations occurred in 29 (7%) patients in the ON group and 20 (20%, P < 0.001) patients in the OFF group. The rate of combined cardiac death and HF hospitalization was lower in patients with Alert ON (log-rank test, P = 0.007). CONCLUSIONS: The ICD reliably detected CE and yielded low rates of unexplained and undetected events. The alert capability seemed to reduce the number of HF hospitalizations by allowing timely detection and therapeutic intervention.

Implantable CRT device diagnostics identify patients with increased risk for heart failure hospitalization.

PURPOSE: To determine the association between device-determined diagnostic indices, including intrathoracic impedance, and heart failure (HF) hospitalization. METHODS: Clinical and device diagnostic data of 558 HF patients indicated for CRT-D therapy (In Sync Sentry, Medtronic Inc.) were prospectively collected from 34 centers. Device-recorded intrathoracic impedance fluid index threshold crossing event (TCE), mean activity counts, tachyarrhythmia events, night heart rate (NHR) and heart rate variability (HRV) were compared within patients with vs. without documented HF hospitalization. RESULTS: Mean follow-up was 326 +/- 216 days. Patients hospitalized for HF had significantly higher rates of TCE, a higher percentage of days with the thoracic impedance fluid index above the programmed threshold, a higher percentage of days with low activity, with low HRV or with high NHR. Multivariate analysis showed that TCE resulted in a 36% increased probability of HF hospitalization. Both TCE duration and patient activity were also significantly associated with hospitalization. Kaplan Meier analysis indicated that patients with more TCE events were significantly more likely to be hospitalized (log rank test, p = 0.005). CONCLUSIONS: Decreased intrathoracic impedance, low patient activity and low HRV were all independently associated with increased risk for HF hospitalization in HF patients treated with resynchronization therapy. Device-derived diagnostic data may provide valuable and reliable indices for the prognostic stratification of HF patients.