Electrical Storm Induced by Cardiac Resynchronization: Efficacy of the Multipoint Pacing Stimulation.

Although cardiac resynchronization therapy (CRT) reduces morbidity and mortality and reverses left ventricular (LV) remodeling in heart failure patients with LV electrical dyssynchrony, induced proarrhythmia has been reported. The mechanism of CRT-induced proarrhythmia remains under debate. In this case report, a description of how LV pacing induced polymorphic ventricular tachycardia immediately after the initiation of CRT has been reported. By changing the pacing configuration using a multipoint pacing stimulation, we can assume that induced ventricular tachycardia is related to the reentry mechanism facilitated by the unidirectional block. As a result, a multipoint pacing (MPP) configuration near the scar area can avoid the onset of a unidirectional block with the establishment of the reentry phenomenon, thus avoiding induced VTs.

Association Between Quality of Life and Procedural Outcome After Catheter Ablation for Atrial Fibrillation: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Catheter ablation is effective in reducing atrial fibrillation (AF), but the association of ablation for AF with quality of life is unclear. Objective: To evaluate whether the procedural outcome of ablation for AF is associated with quality of life (QOL) measures. Design, Setting, and Participants: This was a prespecified secondary analysis of the Substrate and Trigger Ablation for Reduction of Atrial Fibrillation-Part II (STAR AF II) prospective randomized clinical trial, which compared 3 strategies for ablation of persistent AF. This analysis included 549 of the 589 patients enrolled in the trial who underwent ablation. Enrollment occurred at 35 centers in Europe, Canada, Australia, China, and Korea from November 2010 to July 2012. Data for the current study were analyzed on December 11, 2019. Interventions: Patients underwent AF ablation with 1 of 3 ablation strategies: (1) pulmonary vein isolation (PVI), (2) PVI plus complex fractionated electrograms, or (3) PVI plus linear lesions. Main Outcomes and Measures: Quality of life was assessed at baseline and at 6, 12, and 18 months after ablation for AF using the 36-Item Short Form Health Survey and the EuroQol Health-Related Quality of Life 5-Dimension 3-Level questionnaire. Scores were also converted to a physical health component score (PCS) and a mental health component score (MCS). Individual AF burden was calculated by the total time with AF from Holter monitors and the percentage of transtelephonic monitor recordings showing AF. Results: Among the 549 patients included in this secondary analysis, QOL was assessed in 466 (85%) at baseline and at 6, 12, and 18 months after ablation for AF. The mean (SD) age of the study population was 60 (9) years; 434 (79%) individuals were men, and 417 (76%) had continuous AF for 6 months or more before ablation. The AF burden significantly decreased from a mean (SD) of 82% (36%) before ablation to 6.6% (23%) after ablation (P < .001). Significant improvements in mean (SD) PCS (68.3 [20.7] to 82.5 [18.6]) and MCS (35.3 [8.6] to 37.5 [7.6]) occurred 18 months after ablation (P < .05 for both). Significant QOL improvement occurred in all 3 study arms and regardless of AF recurrence, defined as AF episodes lasting more than 30 seconds: for no recurrence, mean (SD) PCS increased from 66.5 (20.9) to 79.1 (19.4) and MCS from 35.3 (8.7) to 37.7 (7.7); for recurrence, mean (SD) PCS increased from 70.2 (20.4) to 86.4 (16.8) and MCS from 35.3 (8.6) to 37.1 (7.4) (P < .05 for all). When outcome was defined by AF burden reduction, in patients with less than 70% reduction in AF burden, the increase in PCS was significantly less than in those with greater than 70% reduction, and only 3 of 8 subscales showed significant improvement. Conclusions and Relevance: In this secondary analysis, decreases in AF burden after ablation for AF were significantly associated with improvements in QOL. Quality of life changes were significantly associated with the percentage of AF burden reduction after ablation. Trial Registration: ClinicalTrials.gov Identifier: NCT01203748.

Real-life outcome of implantable cardioverter-defibrillator and cardiac resynchronization defibrillator replacement/upgrade in a contemporary population: observations from the multicentre DECODE registry.

AIMS: The benefit of prolonged implantable cardioverter-defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) therapy following device replacement is hindered by clinical and procedure-related adverse events (AEs). Adverse events rate is highest in more complex devices and at upgrades, as per the REPLACE registry experience, but is changing owing to the improvement in device technology and medical care. We aimed at understanding the extent and type of AEs in a contemporary Italian population. METHODS AND RESULTS: Detect long-term complications after ICD replacement (DECODE) was a prospective, single-arm, multicentre cohort study aimed at estimating medium- to long-term AEs in a large population of patients undergoing ICD/cardiac resynchronization defibrillator replacement/upgrade from 2013 to 2015. We prospectively analysed all clinical and device-related AEs at 12-month follow-up (FU) of 983 consecutive patients (median age 71 years, 76% male, 55% ischaemic, 47% CRT-D) followed for 353 ± 49 days. Seven percent of the patients died (60.6% for cardiovascular reasons), whereas 104 AEs occurred; 43 (4.4%) patients needed at least one surgical action to treat the AE. Adverse events rates were 3.3/100 years lead-related, 3.4/100 years bleedings, and 1.6/100 years infective. The primary endpoint was predicted by hospitalization in the month prior to the procedure [hazard ratio (HR) = 2.23, 1.16-4.29; 0.0169] and by upgrade (HR = 1.75, 1.02-2.99, 0.0441). One hundred and twelve (11.4%) patients met the combined endpoint of death from any cause, cardiac implantable electronic device (CIED)-related infection, and surgical action/hospitalization required to treat the AE. Hospitalization within 30 days prior to the procedure (HR = 2.07, 1.13-3.81; 0.0199), anticoagulation (HR = 1.97, 1.26-3.07; 0.003), and ischaemic cardiomyopathy (HR = 1.67, 95% confidence interval 1.06-2.63; P = 0.0276) were associated with the combined endpoint during FU. CONCLUSIONS: Adverse events following CIED replacement/upgrade are lower than previously reported, possibly owing to improved patients care. Hospitalization in the month prior to the procedure, upgrade, and clinical profile (anticoagulation, ischaemic cardiomyopathy) hint to increased risk, suggesting an individualized planning of the procedure to minimize overall AEs. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov/ Identifier: NCT02076789.

Remote monitoring of subcutaneous implantable cardioverter defibrillators.

BACKGROUND: Remote monitoring (RM) of implantable cardioverter defibrillators (ICD) has been shown to improve patient safety and reduce in-office visits. The subcutaneous ICD (S-ICD) is an effective alternative to transvenous ICD and has recently been endowed with the RM function. However, the RM communicator for S-ICD requires patient interaction to activate data transmission. We assessed patient compliance and acceptance. METHODS: Patients with S-ICD received the communicator and were followed up for 15 months. Weekly remote transmissions were programmed. Compliance with checks was measured as the number of checks performed by the patient divided by the number of automatic notifications by the communicator. A questionnaire on acceptance of the system was administered to patients. RESULTS: A total of 106 patients were analyzed. The proportion of weekly checks properly executed by the patients was 94% during the first 3 months and 93% from months 12 to 15. Of the checks performed, 93% were on the same day as the automatic notification. On a patient basis, compliance with weekly checks was > 85% (less than one check missed per month) in 88% of patients during the first 3 months and in 82% from months 12 to 15 (p = 0.615). No variables emerged as predictors of lower (≤ 85%) long-term compliance with weekly checks. During follow-up, 49 alerts were transmitted and the mean delay between the detected event and the patient transmission was 2 ± 2 days. The majority of patients found the system easy to use and felt confident about being remotely monitored. CONCLUSIONS: The level of patient compliance with remote checks is high with current technology for RM of S-ICD. The vast majority of data transmissions are consistently performed on a weekly basis on the day scheduled.

Predictors of Zero X-Ray Ablation for Supraventricular Tachycardias in a Nationwide Multicenter Experience.

BACKGROUND: This multicenter, prospective study evaluated the determinants of zero-fluoroscopy (ZFL) ablation of supraventricular tachycardias. METHODS AND RESULTS: Four hundred thirty patients (215 male, 55.4±22.1 years) with indication to electrophysiological study or ablation of supraventricular tachycardias were enrolled. All participating physicians agreed to follow the as low as reasonably achievable policy. A procedure was defined as ZFL when no fluoroscopy was used. The total fluoroscopy time inversely correlated to the number of procedures previously performed by each operator since study start (r=-0.112; P=0.02). Two hundred eighty-nine procedures (67.2%) were ZFL; multivariable analysis identified as predictors of ZFL: procedure after the 30th for each operator, compared with procedures up to the ninth (P=0.011; hazard ratio, 3.49; 95% confidence interval [CI], 1.79-6.80); the type of arrhythmia (P=0.031; electrophysiological study and atrioventricular nodal reentry tachycardia ablation having the highest probability of ZFL; hazard ratio, 6.87; 95% CI, 2.08-22.7 and hazard ratio, 2.02; 95% CI, 1.04-3.91, respectively); the operator's (P=0.002) and patient's age (P=0.009). Among operators, achievement of ZFL varied from 0% to 100%; 8 (22.8%) operators achieved ZFL in <25% of their procedures; 17 (48.6%) operators achieved ZFL in >75% of their procedures. The probability of ZFL increased by 2.8% (hazard ratio, 0.98; 95% CI, 0.97-0.99) as patient's age decreased by 1 year. Acute procedural success was obtained in all cases. CONCLUSIONS: The use of 3-dimensional mapping system completely avoided the use of fluoroscopy in most cases, with very low fluoroscopy time in the remaining and high safety and effectiveness profiles. Achievement of ZFL was predicted by the type of arrhythmia, operator's experience, and patient's age.

Manufacturer change and risk of system-related complications after implantable cardioverter defibrillator replacement: physicians' survey and data from the Detect Long-term Complications After Implantable Cardioverter Defibrillator Replacement Registry.

AIMS: Some barriers seem to exist in changing implantable cardioverter defibrillator (ICD) manufacturer at the time of device replacement. We sought to understand the obstacles to changing ICD manufacturer within the cohort of patients enrolled in the Detect Long-term Complications After ICD Replacement Registry. METHODS: We analyzed 784 consecutive ICD/cardiac resynchronization therapy defibrillator (CRT-D) device replacements within a 1.5-year time-frame in 36 Italian centers to evaluate potential factors associated with changing manufacturers and system-related complications. RESULTS: Manufacturer change occurred in 191 patients (24%): 72/211 single-chamber ICDs (34%), 52/210 dual-chamber ICDs (25%) and 67/363 CRT-D (18%, P < 0.0001 vs. single-chamber). Replacement-only procedures were associated with a lower rate of manufacturer change than upgrading procedures (23 vs. 32%, P = 0.02). In the single-chamber/dual-chamber cohort, the only variables associated with manufacturer change were the number of available manufacturers (OR = 1.9; P < 0.0001) and an upgrade procedure (OR = 1.7; P = 0.035), whereas the center volume was associated with maintenance of the same manufacturer (OR = 0.5; P = 0.0172). In the CRT-D group, the number of available manufacturers [OR = 2.9; P < 0.0001, service life below the median value (OR = 2.5; P = 0.0026)], and physiological design (OR = 8.4; P = 0.0048) were associated with manufacturer change. At 6-month follow-up, 17 patients (2.2%) experienced a system complication that was lead-related in all cases; upgrade procedure was the only predictor (hazard ratio = 6.7) of complications. CONCLUSION: At the time of ICD replacement, a manufacturer change occurred in 24% of patients and it was less likely in CRT-D devices, which are equipped with more specific technology and less frequently require the addition of features. System-related complications are strongly associated to upgrade procedures rather than to manufacturer change.

Impact of acute atrial fibrillation termination and prolongation of atrial fibrillation cycle length on the outcome of ablation of persistent atrial fibrillation: A substudy of the STAR AF II trial.

BACKGROUND: Controversy exists about the impact of acute atrial fibrillation (AF) termination and prolongation of atrial fibrillation cycle length (AFCL) during ablation on long-term procedural outcome. OBJECTIVE: The purpose of this study was to analyze the influence of AF termination and AFCL prolongation on freedom from AF in patients from the STAR AF II (Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial-Part II) trial. METHODS: Acute changes in AFCL and AF termination were collected during the index procedure of the STAR AF II trial and compared to recurrence of AF at 18 months. Recurrence was assessed by ECG, Holter (3, 6, 9, 12, 18 months), and weekly transtelephonic ECG monitoring for 18 months. RESULTS: AF terminated in 8% of the pulmonary vein isolation (PVI) arm, 45% in the PVI+complex electrogram arm, and 22% of the PVI+linear ablation arm (P <.001), but freedom from AF did not differ among the 3 groups (P = .15). Freedom from AF was significantly higher in patients who presented to the laboratory in sinus rhythm (SR) compared to those without AF termination (63% vs 44%, P = .007). Patients with AF termination had an intermediate outcome (53%) that was not significantly different from those in SR (P = .84) or those who did not terminate (P = .08). AF termination was a univariable predictor of success (P = .007), but by multivariable analysis, presence of early SR was the strongest predictor of success (hazard ratio 0.67, P = .004). Prolongation of AFCL was not predictive of 18-month freedom from AF. CONCLUSION: Acute AF termination and prolongation in AFCL did not consistently predict 18-month freedom from AF. Presence of SR before or early during the ablation was the strongest predictor of better outcome.

Device Longevity in a Contemporary Cohort of ICD/CRT-D Patients Undergoing Device Replacement.

INTRODUCTION: The longevity of defibrillators (ICD) is extremely important from both a clinical and economic perspective. We studied the reasons for device replacement, the longevity of removed ICD, and the existence of possible factors associated with shorter service life. METHODS AND RESULTS: Consecutive patients who underwent ICD replacement from March 2013 to May 2015 in 36 Italian centers were included in this analysis. Data on replaced devices were collected. A total of 953 patients were included in this analysis. In 813 (85%) patients the reason for replacement was battery depletion, while 88 (9%) devices were removed for clinical reasons and the remaining 52 because of system failure (i.e., lead or ICD generator failure or a safety advisory indication). The median service life was 5.9 years (25th-75th percentile, 4.9-6.9) for single- and dual-chamber ICD and 4.9 years (25th-75th percentile, 4.0-5.7) for CRT-D. On multivariate analysis, the factors CRT-D device, SC/DC ICD generator from Biotronik, percentage of ventricular pacing, and the occurrence of a system failure were positively associated with a replacement procedure. By contrast, the device from Boston Scientific was an independent protective factor against replacement. Considerable differences were seen in battery duration in both ICD and CRT-D. Specifically, Biotronik devices showed the shortest longevity among ICD and Boston Scientific showed the longest longevity among CRT-D (log-rank test, P < 0.001 for pairwise comparisons). CONCLUSION: Several factors were associated with shorter service life of ICD devices: CRT-D, occurrence of system failure and percentage of ventricular pacing. Our results confirmed significant differences among manufacturers.

Approaches to catheter ablation for persistent atrial fibrillation.

BACKGROUND: Catheter ablation is less successful for persistent atrial fibrillation than for paroxysmal atrial fibrillation. Guidelines suggest that adjuvant substrate modification in addition to pulmonary-vein isolation is required in persistent atrial fibrillation. METHODS: We randomly assigned 589 patients with persistent atrial fibrillation in a 1:4:4 ratio to ablation with pulmonary-vein isolation alone (67 patients), pulmonary-vein isolation plus ablation of electrograms showing complex fractionated activity (263 patients), or pulmonary-vein isolation plus additional linear ablation across the left atrial roof and mitral valve isthmus (259 patients). The duration of follow-up was 18 months. The primary end point was freedom from any documented recurrence of atrial fibrillation lasting longer than 30 seconds after a single ablation procedure. RESULTS: Procedure time was significantly shorter for pulmonary-vein isolation alone than for the other two procedures (P<0.001). After 18 months, 59% of patients assigned to pulmonary-vein isolation alone were free from recurrent atrial fibrillation, as compared with 49% of patients assigned to pulmonary-vein isolation plus complex electrogram ablation and 46% of patients assigned to pulmonary-vein isolation plus linear ablation (P=0.15). There were also no significant differences among the three groups for the secondary end points, including freedom from atrial fibrillation after two ablation procedures and freedom from any atrial arrhythmia. Complications included tamponade (three patients), stroke or transient ischemic attack (three patients), and atrioesophageal fistula (one patient). CONCLUSIONS: Among patients with persistent atrial fibrillation, we found no reduction in the rate of recurrent atrial fibrillation when either linear ablation or ablation of complex fractionated electrograms was performed in addition to pulmonary-vein isolation. (Funded by St. Jude Medical; ClinicalTrials.gov number, NCT01203748.).

Characterization of ventricular activation pattern and acute hemodynamics during multipoint left ventricular pacing.

BACKGROUND: Multipoint left ventricular (LV) pacing (MultiPoint Pacing [MPP], St Jude Medical, Sylmar, CA) in a single coronary sinus branch has been introduced as a novel means of cardiac resynchronization therapy (CRT). It is speculated that MPP improves LV function by capturing a larger LV tissue area, resulting in uniform wavefront propagation throughout the ventricles, in comparison to conventional biventricular pacing (BIV). OBJECTIVE: The purpose of this study was to evaluate MPP by means of contact mapping and hemodynamic measures to understand the underlying mechanisms and effects. METHODS: Ten patients with non-ischemic cardiomyopathy (mean age 69 ± 9 years; 6 men (60%); New York Heart Association heart failure class II or III; QRS duration 173 ± 20 ms; LV ejection fraction 27% ± 5%) received a CRT-defibrillator capable of MPP. After the implantation procedure, an acute pacing protocol was implemented, including 2 BIV and up to 9 MPP interventions. In all pacing interventions, LV electrical activation patterns and hemodynamics (dP/dtmax) were evaluated, and for each patient, both the resulting measures were compared between MPP and BIV interventions. RESULTS: Compared with BIV, MPP resulted in an increase in LV dP/dtmax (30% ± 13% vs. 25% ± 11%; P = .041), a reduction in QRS duration (22% ± 11% vs. 11% ± 11%; P = .01), and a decrease in total endocardial activation time (25% ± 15% vs. 10% ± 20%; P = .01). MPP resulted in a larger capture of LV mass during the first 25 ms (35% ± 22% vs. 16% ± 8%; P = .005) and during the first 50 ms (78% ± 27% vs. 60% ± 23%; P = .03) of pacing, suggesting a quicker wavefront propagation throughout the left ventricle. CONCLUSION: In this acute study, MPP in CRT improved both endocardial and surface electrical parameters and hemodynamics in comparison with BIV.

Single-center experience of a quadripolar pacing lead for cardiac resynchronization therapy.

AIM: Recent studies have shown that a quadripolar left ventricular (LV) lead can result in low rates of dislocation and phrenic nerve stimulation (PNS) acutely and on medium-term follow-up in cardiac resynchronization therapy (CRT). We evaluated the outcomes of CRT patients in whom a quadripolar LV lead was implanted in our institution. METHODS: We studied 45 consecutive heart failure patients (75 % men; age, 70.3 ± 9.0 years) following successful implantation of a quadripolar LV lead. Demographic and clinical data were collected preoperatively, and patients were followed up for 18.9 months. RESULTS: The implantation success rate was 100 %. Mean overall duration was 100.1 ± 34.6 min, and X-ray exposure time was 13.20 ± 13.5 min. The most distal effective pacing site was used as the final pacing configuration in all patients. Acute dislodgment requiring reoperation occurred before discharge in three cases (6.6 %). Six patients (13 %) suffered PNS during follow-up; we solved this problem by changing the stimulation vector. Three months after implantation, a mean of six out of ten effective sites (threshold <2.5 V at 1.5 ms, no PNS) per patient was recorded. CONCLUSIONS: Over the relatively long term, the quadripolar LV lead was associated with excellent pacing thresholds and low rates of dislocation and PNS.

Catheter ablation of atrial fibrillation guided by a 3D electroanatomical mapping system: a 2-year follow-up study from the Italian Registry On NavX Atrial Fibrillation ablation procedures (IRON-AF).

AIMS: Clinical trials have established that atrial fibrillation (AF) catheter ablation improves symptoms in appropriately selected patients. Confirmation of these results by long-term prospective observational studies is needed. This registry was created to describe the experience of 16 Italian centers with a large cohort of AF patients treated with catheter ablation guided by the NavX 3D mapping system. METHODS: From November 2006 to May 2008, 545 consecutive patients (age 60.4 ± 9.8, 67 % male) with paroxysmal (44 %), persistent (43 %), and long-standing persistent (13 %) AF referred for catheter ablation guided by the NavX system, were included in this registry. For this paper, follow-up was censored at 24 months; however, patients are being followed in the ongoing registry. RESULTS: Before the ablation, 80 % of patients failed to respond to at least one antiarrhythmic drug aimed at rhythm control. Pulmonary vein (PV) isolation guided by a circular mapping catheter was performed in 70 % of patients whereas non potential-guided PV encircling was performed in 30 % of patients. In 67 % of patients, additional left atrial (LA) substrate modification was performed. Image integration was performed in 9.2 % of patients. Considering a 3-month blanking period, after a single-ablation procedure, the patients had 1- and 2-year freedom from AF recurrence of 67.4 and 57.0 % (36.1 % off antiarrhythmic drugs), respectively. Cox regression analysis showed that AF recurrences during blanking (HR 2.1), and previous AF ablation (HR 3.3) were independent predictors of AF recurrences. Major procedure-related complications occurred in 53 patients (9.7 %). In 35 patients (6.7 %), a repeat procedure was performed at a median of 5 months after the initial procedure. CONCLUSIONS: This prospective, multicenter clinical experience provides significant insights into current ablation care of patients with AF. Despite favorable outcomes, real-world complication rates appear higher than previously recognized.

Risk stratification of ischaemic patients with implantable cardioverter defibrillators by C-reactive protein and a multi-markers strategy: results of the CAMI-GUIDE study.

AIMS: Patients at risk of sudden cardiac death (SCD) after myocardial infarction (MI) can be offered therapy with implantable cardioverter defibrillators (ICDs). Whether plasma biomarkers can help risk stratify for SCD and ventricular arrhythmias (VT/VF) is unclear. METHODS AND RESULTS: The primary objective of the CAMI-GUIDE study is to assess the predictive role of C-reactive protein for SCD or VT/VF in ischaemic patients with the ejection fraction <30% and ICDs. Secondary endpoints included all-cause mortality, hospitalizations, and death from heart failure. Additional analyses incorporated cystatin-C and NT-ProBNP in multi-marker approach for the prediction of adverse outcomes. A total of 300 patients were enrolled. All-cause mortality at 2 years was 22.6%, mortality from heart failure was 8.3%. Primary endpoint occurred in 17.3%. At a competing risk multivariable analysis adjusted for baseline variables, no significant difference in primary endpoint was found between patients with C-reactive protein ≤3 vs. >3 mg/L [heart rate (HR) 0.91 (0.50-1.64) P = 0.76], while C-reactive protein >3 mg/L was strongly associated with mortality due to heart failure [HR: 3.17 (1.54-6.54) P = 0.002]. NT-proBNP above median was significantly associated with the primary endpoint [adjusted HR: 1.46 (1.020-2.129) P = 0.042]. A risk function, including the three biomarkers, NYHA class and resting HR, allowed stratification of patient mortality risk from 5 to 50%. CONCLUSION: C-reactive protein >3 mg/L is not associated with SCD or fast VT/VF, however, is a strong predictor of HF mortality. Biomarkers combined with clinical markers allow an excellent risk stratification of mortality at 2 years.

Cardiac resynchronization therapy modifies the neurohormonal profile, hemodynamic and functional capacity in heart failure patients.

BACKGROUND: Cardiac resynchronization therapy (CRT) has been shown to improve the clinical status and survival in congestive heart failure (CHF) patients, but little is known about its influence on neurohormonal profile. METHODS: Heart failure patients treated with CRT for moderate/severe heart failure were studied with echocardiography, cardiopulmonary test, and neurohormonal profile [brain natriuretic peptide (BNP), endothelin (END), big endothelin (big-END), epinephrine (EPI), tumor necrosis factor-alpha (TNF-alpha)] at baseline and after 1 year from the pacemaker implantation. RESULTS: 120 NYHA II-IV patients entered this study, all with an indication to CRT; 100 agreed to be implanted (group A), whereas 20 refused, identifying a control group (group B). In group A NYHA class (from 3.15+/-0.49-1.15+/-0.49, p=0.001), left ventricular ejection fraction (from 19.6+/-4.95-35.6+/-5.95%, p=0.001), severity of mitral regurgitation (from 13.3+/-4.19-6.09+/-4.11 cmq, p=0.001), and peak VO(2) (from 9.68+/-4.61-13.35+/-3.32 mL/kg/min, p=0.001) improved at 1-year follow-up. In the neurohormonal profile only plasma BNP (from 185.1+/-185.9-110.2+/-137.5 pg/mL, p=0.03) and big-END (from 1.8+/-1.5-0.87+/-0.7 fmol/mL, p=0.007) were reduced significantly. None of these parameters significantly changed in the control group at 1-year follow-up. CONCLUSIONS: In patients with moderate/severe heart failure, CRT improved clinical status and the functional parameters modifying the neurohormonal profile at 1-year follow-up.

Effects of the addition of a low dose of spironolactone on brain natriuretic peptide plasma level and cardiopulmonary function in patients with moderate congestive heart failure.

BACKGROUND: The purpose of our study was to assess the effects of a low dose of spironolactone in patients with moderate congestive heart failure (CHF) on the plasma level of brain natriuretic peptide (BNP), echocardiographic left ventricular ejection fraction (LVEF), and cardiopulmonary function assessed by cardiopulmonary (CP) test. MATERIAL/METHODS: 51 CHF patients (74.5% males, mean age 60 years) underwent transthoracic echocardiography, CP test, and plasma BNP assay at the time of enrollment and after 6 months of standard therapy for CHF plus a low dose of spironolactone (group A). A control group (21 patients, group B) was treated using standard therapy only. All subjects were in NYHA class I-III and had LVEF < or = 40%. RESULTS: BNP concentration decreased significantly (from 45.7+/-57.4 pg/ml to 18.6+/-26.9 pg/ml at follow-up; p=0.01), and the NYHA class and LVEF improved (2.2+/-0.6 vs 1.7+/-0.5, p=0.0001; 27.7+/-7.2% vs 35.1+/-11%, p=0.001 respectively) in subjects in group A. In spite of clinical amelioration, peak oxygen consumption, oxygen pulse and anaerobic threshold in the CP test did not change significantly (16.6+/-5.7 ml/kg/min vs 17.1+/-5.3 ml/kg/min p=0.5; 8.8 +/- 4.3 ml/beat vs 9.5+/-3.6 ml/beat p=0.2; 0.75+/-0.2 ml/Kg/min vs 0.73+/-0.2 ml/Kg/min p=0.7). No differences were noticed in the control group. CONCLUSIONS: The addition of spironolactone reduced the BNP plasma level in patients with moderate CHF and increased LVEF. This therapy improved the NYHA class without modifying the functional parameters in the CP test.