Impact of dual-chamber pacing with closed loop stimulation on quality of life in patients with recurrent reflex vasovagal syncope: results of the SPAIN study.

AIMS: Reflex vasovagal syncope (VVS) is the most common cause of syncope and patients with recurrent episodes may severely impair quality of life (QoL). This pre-specified analysis evaluated whether the clinically significant reduction in syncope burden demonstrated by dual-chamber pacing with closed loop stimulation (DDD-CLS) reported in the SPAIN trial translates into improved QoL. METHODS AND RESULTS: Patients aged ≥40 years with ≥5 VVS episodes and cardioinhibitory response induced by head-up tilt testing were included. Patients were randomized 1:1 to active DDD-CLS pacing algorithm for 12 months followed by sham DDI mode for the remaining 12 months (Group A) or vice versa (Group B). QoL was assessed using the Short Form-36 (SF-36) health survey, Physical Component Score (PCS), and Mental Component Score (MCS) before randomization (baseline) and at 12- and 24-month follow-up. Fifty-four patients were enrolled from 11 participating centres. No significant carryover effect was detected for any variable, and the only period effect was observed in the vitality subdomain (P = 0.033). Mean SF-36 scores were higher in the DDD-CLS group vs. the DDI group for the eight subdomains and significantly different in physical role, bodily pain, and vitality (P < 0.05). The analysis of component summary scores indicated that DDD-CLS benefited both mental and physical components with significant differences in PCS when compared with the DDI group. CONCLUSION: Dual-chamber pacing with closed loop stimulation determined a significant and clinically relevant improvement in QoL across both mental and physical components in patients with recurrent VVS. REGISTRATION: Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study); NCT01621464.

Dual-Chamber Pacing With Closed Loop Stimulation in Recurrent Reflex Vasovagal Syncope: The SPAIN Study.

BACKGROUND: Pacing in vasovagal syncope remains controversial. OBJECTIVES: The authors evaluated dual-chamber pacing with closed loop stimulation (DDD-CLS) in patients with cardioinhibitory vasovagal syncope. METHODS: This randomized, double-blind, controlled study included Canadian and Spanish patients age ≥40 years, with high burden syncope (≥5 episodes, ≥2 episodes in the past year), and a cardioinhibitory head-up tilt test (bradycardia <40 beats/min for 10 s or asystole >3 s). Patients were randomized to either DDD-CLS pacing for 12 months followed by sham DDI mode pacing at 30 pulses/min for 12 months (group A), or sham DDI mode for 12 months followed by DDD-CLS pacing for 12 months (group B). Patients in both arms crossed-over after 12 months of follow-up or when a maximum of 3 syncopal episodes occurred within 1 month. RESULTS: A total of 46 patients completed the protocol; 22 were men (47.8%), and mean age was 56.30 ± 10.63 years. The mean number of previous syncopal episodes was 12 (range 9 to 20). The proportion of patients with ≥50% reduction in the number of syncopal episodes was 72% (95% confidence interval [CI]: 47% to 90%) with DDD-CLS compared with 28% (95% CI: 9.7% to 53.5%) with sham DDI mode (p = 0.017). A total of 4 patients (8.7%) had events during DDD-CLS and 21 (45.7%) during sham DDI (hazard ratio: 6.7; 95% CI: 2.3 to 19.8). Kaplan-Meier curve was significantly different between groups in time to first syncope: 29.2 months (95% CI: 15.3 to 29.2 months) versus 9.3 months (95% CI: 6.21 months, NA; p < 0.016); odds ratio: 0.11 (95% CI: 0.03 to 0.37; p < 0.0001). CONCLUSIONS: DDD-CLS pacing significantly reduced syncope burden and time to first recurrence by 7-fold, prolonging time to first syncope recurrence in patients age ≥40 years with head-up tilt test-induced vasovagal syncope compared with sham pacing. (Closed Loop Stimulation for Neuromediated Syncope [SPAIN Study]; NCT01621464).

[In-hospital and long-term mortality in women with acute myocardial infarction treated by primary angioplasty]. / Mortalidad a corto y largo plazo en mujeres con infarto de miocardio tratado con angioplastia primaria.

INTRODUCTION AND OBJECTIVES: Mortality and morbidity after ST-elevation myocardial infarction (STEMI) are higher in women than men. It is not clear whether reperfusion by elective treatment with primary angioplasty can improve the poor prognosis in women with this condition. The objective of this study was to determine the effect of sex on clinical characteristics, and on in-hospital and long-term outcomes in patients with STEMI undergoing reperfusion by primary angioplasty. METHODS: A prospective observational study was performed in 838 consecutive patients with STEMI treated by primary angioplasty at a single hospital. Of these, 183 (22%) were women. RESULTS: Women were older (70 years vs 62 years; P<.01), were less frequently smokers (8% vs 53%; P<.01), more frequently had diabetes (45% vs 27%; P<.01) or hypertension (59% vs 36%; P<.01), presented later for angioplasty (4.1 h vs 3.6 h; P=.05), and experienced cardiogenic shock more frequently during the procedure (21% vs 12%; P<.01). There were no differences in the culprit vessel most often responsible for the infarction, in the procedural success rate, or in stent or glycoprotein IIb/IIIa inhibitor use. The total in-hospital mortality rate was higher in women (22% vs 9%; P<.01), as was the adjusted in-hospital rate (odds ratio 2.5, 95% confidence interval 1.2-5.2). During long-term follow-up after discharge (median 35.4 months), there was no significant difference in age-adjusted survival rate (relative risk 1.2, 95% confidence interval 0.7-1.9). CONCLUSIONS: Despite recent advances in the treatment of STEMI, women experience greater in-hospital mortality, even after adjustment for baseline clinical characteristics. However, the long-term age-adjusted mortality rate in women discharged from hospital was similar to that in men.

[Early heart rate increase does not predict the result of the head-up tilt test potentiated with nitroglycerin]. / El incremento temprano de la frecuencia cardíaca no predice el resultado de la prueba de basculación potenciada con nitroglicerina.

INTRODUCTION AND OBJECTIVES: The magnitude of the change in heart rate during the first few minutes of the head-up tilt test has been used to predict the test's result. The aim of this study was to investigate whether the heart rate increase during the head-up tilt test potentiated with nitroglycerin is related to the development of syncope. PATIENTS AND METHOD: The study included 158 consecutive patients with syncope, with stable sinus rhythm, and without structural cardiac disease who were undergoing a head-up tilt test with nitroglycerin. The heart rate increment induced by the tilt maneuver and by nitroglycerin administration was calculated, and its relationship to clinical variables and to the test's results was analyzed. RESULTS: The head-up tilt test gave positive results in 117 patients (74%). The heart rate was 68.7 (11.3) bpm in the decubitus position and 85.1 (15.4) bpm during the first 6 min of tilting. There was strong inverse correlation between the heart rate increase induced by tilting and age (r=--0.63; P<.001), but the increase (16.8 [9.3] bpm in patients with syncope versus 14.9 [11.3] bpm in those without; P=.3) did not predict the result of the test. The heart rate increase induced by nitroglycerin was also similar for patients with and without syncope during the pharmacologic phase of the test (27.3 [12.6] bpm and 26.7 (13.4) bpm, respectively; P=.8). CONCLUSIONS: The magnitude of the heart rate increase during the first few minutes of tilt-testing and after nitroglycerin administration is inversely related to age but does not predict the result of the head-up tilt test with nitroglycerin.

[Effect of time elapsed from spontaneous syncope on the diagnostic performance of the head-up tilt table test]. / Efecto del tiempo transcurrido tras el síncope sobre el rendimiento diagnóstico de la prueba de basculación.

OBJECTIVES: The propensity for spontaneous and tilt-induced neurocardiogenic syncope may exhibit temporal variations. Therefore the diagnostic performance of the head-up tilt test could be improved if it were performed soon after the occurrence of spontaneous syncope. The objective of this study was to assess whether the time interval between the last syncopal episode and tilt table testing influenced the outcome of the test. PATIENTS AND METHOD: Three hundred and fifteen patients undergoing diagnostic tilt table testing potentiated with nitroglycerin for suspected neurocardiogenic syncope were included in the study. The time between the last spontaneous syncope and the tilt table test was recorded and its relationship with the results of the test was analyzed. RESULTS: The tilt table test was positive in 211 patients (67.0%). The time from syncope to test was similar for patients with positive and negative tilt table test results: 28 (1-500) vs 32 (2-700) days (NS). No significant relation was observed between the results of the test and the occurrence of spontaneous syncope during the week, the month or the three months previous to the procedure. However, in men and in patients older than 50 years a higher rate of positive tests was observed if the tilt test was performed within the first month after the last spontaneous syncope. CONCLUSIONS: The time from the last previous spontaneous syncope to the head-up tilt test does not have a significant impact on test outcome in the overall population with suspected neurocardiogenic syncope. However, the rate of positivity might decrease in men and patients older than 50 years if the test is performed later than one month after the spontaneous syncopal episode.

[Head-up tilt test potentiated with nitroglycerin. What is the optimal duration of the test after administration of the drug?]. / Prueba de basculación potenciada con nitroglicerina: 'cuánto debe durar la prueba tras la administración del fármaco?

INTRODUCTION AND OBJECTIVES: Numerous variations of the head-up tilt-table test potentiated with nitrates have been reported. After the administration of nitroglycerin, between 10 and 25 min of continued tilting have been recommended. The aim of this study was to assess the optimal duration of the pharmacological phase of the head-up tilt-table test potentiated with sublingual administration of nitroglycerin spray (NTG-TT). METHOD: The records of 498 consecutive NTG-TT were reviewed. Our protocol consisted of a 20-min drug-free phase at a 60o angle. If syncope does not develop, 400 microgram of sublingual nitroglycerin spray is administered and the patient continues to be tilted for a further 25 min. The test results and time to a positive response were analyzed. RESULTS: The result of NTG-TT was positive in 288 procedures, most of them after nitroglycerin administration (255, 88.5%). The mean time to a positive response was 10.7 6.7 and 5.0 2.4 min during the control and pharmacological phases respectively. Most positive responses were concentrated in the 3 to 5 min after drug administration. The time to syncope after nitroglycerin administration was over 10 min in 9 patients and 15 min in only 2 patients. CONCLUSIONS: The duration of the pharmacological phase of NTG-TT using the described protocol can be reduced to 15 min without loss of sensitivity. A further reduction to 10 min would decrease the rate of positive responses by a small amount and might be considered clinically acceptable.

Emergency percutaneous coronary intervention in unprotected left main coronary arteries. Predictors of mortality and impact of cardiogenic shock.

INTRODUCTION AND OBJECTIVES: Percutaneous coronary intervention (PCI) for unprotected left main coronary artery (LMCA) disease may be essential following acute myocardial infarction (AMI). However, few data are available on the use of emergency PCI in unprotected LMCAs outside of clinical trials. The objective of this study was to determine the frequency of in-hospital mortality, its predictors and its association with cardiogenic shock, and long-term outcomes in patients with unprotected LMCA disease who undergo emergency PCI because of AMI. METHODS: The study included 71 consecutive patients who underwent emergency angioplasty of the LMCA and who were followed up clinically. RESULTS: Overall, 42 patients (59%) had ST-elevation AMI and 47 (66%) had cardiogenic shock or developed it during PCI. Eleven patients (16%) died in the catheterization laboratory and 33 (47%) died during hospitalization. Inhospital mortality was similar in those with and without evidence of ST-segment elevation on ECG (48% vs. 45%; P=1). Multivariate analysis showed that the predictors of in-hospital mortality were cardiogenic shock (odds ratio [OR]=4.5; 95% confidence interval [CI], 1.1-18) and incomplete revascularization (OR=5.1; 95% CI, 1.0-26). After discharge, 39 patients were followed up for a median of 32 months. Mortality in the first year was 10%. CONCLUSIONS: Emergency PCI is a viable therapeutic option for AMI due to unprotected LMCA disease. However, in-hospital mortality is high, regardless of ST-segment elevation, particularly if there is cardiogenic shock or complete revascularization has not been achieved.