Defining the blanking period, using continuous ECG monitoring, after cryoballoon pulmonary vein isolation.

BACKGROUND: Pulmonary vein isolation (PVI) is the cornerstone of atrial fibrillation (AF) ablation. A blanking period (BP) of 3 months is used in clinical trials and practice. However, the optimal BP duration after PVI remains undefined. OBJECTIVE: The aim of this study was to objectively define, using continuous monitoring by an implantable loop recorder, the optimal BP duration after cryoballoon PVI. METHODS: We enrolled consecutive patients who had cryoballoon PVI and an implantable loop recorder. We determined the time of the last confirmed episode of AF within the blanking period. This was then correlated with AF recurrence in the first year after ablation. RESULTS: There were 210 patients (66 ± 9 years; 138 [66%] male; 116 [55%] paroxysmal AF; CHA2DS2-VASc score, 2.5 ± 1.6). We defined 4 distinct groups based on the last AF episode within the BP: no AF days 0-90 (n = 96 [46%]) and last AF 0-30 days (n = 46 [22%]), 31-60 days (n = 18 [9%]), and 61-90 days (n = 50 [24%]). After the 3-month BP, 101 (48%) patients had AF recurrence at 160 ± 86 days. Compared with patients with no AF in the BP, those with recurrent AF and AF burden >0% 30 days after ablation had a significantly greater AF recurrence during long-term follow-up (P = .001). CONCLUSION: Our data show that the approximately one-third of patients in whom AF occurs and who have a burden of >0% after the first month that follows PVI are at significantly higher risk of long-term recurrent AF. We therefore suggest that the blanking period be limited to a month after cryoballoon PVI.

Incidence and Predictors of Very Late Recurrence of Atrial Fibrillation Following Cryoballoon Pulmonary Vein Isolation.

BACKGROUND: A very late recurrence (VLR) of atrial fibrillation (AF) is considered present when the first recurrence of AF occurs ≥12 months following ablation. Prior studies characterizing VLR have not used an implantable loop recorder for ECG monitoring. Thus, it is unknown whether VLR truly occurs or whether these patients have simply had unrecognized AF. Our objective was to assess the incidence and predictors of VLR in patients who underwent cryoballoon pulmonary vein isolation alone, had an implantable loop recorder, and were confirmed AF free for at least 1 year. METHODS: We enrolled consecutive patients with paroxysmal or persistent AF who underwent cryoballoon pulmonary vein isolation and had an implantable loop recorder implanted <3 months post-ablation. Patients free of AF 1 year post-ablation were followed prospectively for recurrent AF. All AF episodes were adjudicated. RESULTS: We included 188 patients (66±10 years; 116 [62%] men; 102 [54%] paroxysmal AF; CHA2DS2-VASc, 2.6±1.7). After 1 year post-pulmonary vein isolation, 93 (49%) patients remained AF free. During subsequent follow-up, 30 (32%) patients had VLR of AF. The only independent risk factor for VLR was an elevated CHA2DS2-VASc score (hazard ratio, 1.317 [95% CI, 1.033-1.6979]; P=0.026). Patients with CHA2DS2-VASc score ≥4 represented a quarter of the population and were at the highest risk. CONCLUSIONS: Our data using implantable loop recorders for continuous ECG monitoring post-AF ablation show that VLR occurs in a third of patients after an apparently successful cryoballoon pulmonary vein isolation procedure. Additional strategies are needed to ensure long-term freedom from AF recurrences in these high-risk patients.

Detection of atrial fibrillation using an implantable loop recorder following cryptogenic stroke: implications for post-stroke electrocardiographic monitoring.

PURPOSE: Approximately 10-40% of strokes are cryptogenic (CS). Long-term electrocardiographic (ECG) monitoring has been recommended in these patients to search for atrial fibrillation (AF). An unresolved issue is whether ambulatory ECG (AECG) monitoring should be performed first, followed by an implantable loop recorder (ILR) if AECG monitoring is non-diagnostic, or whether long-term ECG monitoring should be initiated using ILRs from the onset. The purpose of this study was to assess, using an ILR, AF incidence in the first month after CS. METHODS: We enrolled consecutive CS patients referred for an ILR. All patients were monitored via in-hospital continuous telemetry from admission until the ILR (Medtronic [Minneapolis, MN] LINQ™) was implanted. The duration and overall burden of all AF episodes ≥ 2 min was determined. RESULTS: The cohort included 343 patients (68 ± 11 years, CHA2DS2-VASc 3.5 ± 1.7). The time between stroke and ILR was 3.7 ± 1.5 days. During the first 30 days, only 18 (5%) patients had AF. All episodes were paroxysmal, lasting from 2 min to 67 h and 24 min. The median AF burden was 0.85% (IQR 0.52, 10.75). During 1 year of follow-up, 67 (21%) patients had AF. CONCLUSION: The likelihood of AF detection by an ILR in the first month post-CS is low. Thus, the diagnostic yield of 30 days of AECG monitoring is likely to be limited. These data suggest a rationale for proceeding directly to ILR implantation prior to hospital discharge in CS patients, as many have AF detected during longer follow-up.

Incidence, duration, pattern, and burden of de novo atrial arrhythmias detected by continuous ECG monitoring using an implantable loop recorder following ablation of the cavotricuspid isthmus.

Background: Following cavotricuspid isthmus (CTI) ablation, many patients with atrial flutter (AFL) are diagnosed with atrial fibrillation (AF). The incidence, duration, pattern, and burden of AF remain undefined. These may have implications for the management of these patients. Objective: To classify the incidence, duration, pattern, and burden of AF/AFL using an implantable loop recorder (ILR) after CTI ablation. Methods: We enrolled consecutive patients with CTI-dependent AFL, no known history of AF, and CHA2DS2-VASc ≥ 2. An ILR was implanted before or within 90 days of ablation. The time to first AF/AFL, pattern, duration, and burden of longest AF/AFL were determined. Five distinct AF/AFL cohorts were identified: no AF/AFL and those with recurrences of isolated, clustered, frequent, or persistent AF/AFL. Results: Fifty-two patients (81% male; 73 ± 9 years; CHA2DS2-VASc 3.7 ± 1.2) were followed for 784 (interquartile range [IQR] 263, 1150) days. AF/AFL occurred in 44 (85%) patients at 64 (IQR 8, 189) days post-CTI ablation and was paroxysmal in 31 (70%) patients (burden 0.6% [IQR 0.1, 4.8]). AF/AFL was isolated (n = 5, 11%), clustered (n =7, 16%), frequent (n =19, 43%), and persistent (n =13, 30%). The longest AF episode was <24 hours in 27 (61%) patients. Conclusion: Following CTI ablation in AFL patients, although AF/AFL occurs in most patients, the burden is low and episodes were <24 hours in the majority of patients. Additional studies are needed to determine whether long-term electrocardiographic monitoring can help guide management of patients undergoing CTI ablation.

Brugada Syndrome Unmasked by Use of Testosterone in a Transgender Male: Gender Trumps Sex as a Risk Factor.

We describe a genetic female living as a transgender male through the use of exogenous testosterone supplementation. He developed Brugada pattern (that was unrecognized) and subsequently had an out-of-hospital cardiac arrest. Sustained ventricular arrhythmias were suppressed through treatment with quinidine; however, this medication could only be administered at very low doses due to the development of angioedema at higher doses. Subsequently, the patient required endocardial ablation for elimination of highly symptomatic, repetitive monomorphic ventricular ectopy. This case highlights the presentation of a unique patient in whom a channelopathy was unmasked by the patient's lifestyle, suggesting that gender trumps sex when it comes to arrhythmia risk in patients at risk for Brugada syndrome.

The Efficacy of His Bundle Pacing: Lessons Learned From Implementation for the First Time at an Experienced Electrophysiology Center.

OBJECTIVES: This study sought to evaluate the clinical and procedural characteristics impacting outcomes during implementation of a His bundle pacing (HBP) program in a real-world setting. BACKGROUND: Right ventricular pacing is associated with an elevated risk of heart failure, but device reprogramming and upgrades have significant challenges. HBP has emerged as an alternative and is reported to be highly successful in the hands of highly experienced centers. METHODS: All patients referred for permanent pacemaker implantation at the Valley Hospital (Ridgewood, New Jersey) between October 2015 and October 2017 were evaluated; a subset of 24% was selected for HBP. RESULTS: Permanent HBP was feasible with an acute implant success rate of 75%. HBP in the presence of bundle branch block (64% vs. 85%; p = 0.05) or complete heart block (56% vs. 83%; p = 0.03) was significantly less successful. The pattern of atrioventricular block in combination with bundle branch block (BBB) further affects outcomes. HBP is highly successful across the spectrum of atrioventricular block pattern severity in the absence of BBB. In the presence of BBB, Mobitz II AV block and complete heart block significantly attenuated HBP success compared with Mobitz I atrioventricular block (62% vs. 100%; p = 0.02). A rising threshold was observed in 30%, and 8% required lead intervention. CONCLUSIONS: HBP was feasible and readily learned with a high implant success in the hands of experienced electrophysiologists without prior exposure to the technique. BBB and atrioventricular block pattern appears to affect success. The technique is limited by a high rate of rising thresholds and lead intervention. These data have important implications for patient selection.

Focal impulse and rotor modulation: Acute procedural observations and extended clinical follow-up.

BACKGROUND: Focal impulse and rotor modulation (FIRM) was based on the premise that atrial fibrillation (AF) is sustained by rotors that are sufficiently stable to be eliminated by targeted ablation. Early experience reported high success as compared to conventional strategies. OBJECTIVE: The purpose of this study was to report on a single-center experience with extended follow-up by using FIRM in a variety of patients with AF. METHODS: All FIRM-guided ablation procedures were included. During spontaneous or induced AF, FIRM software constructed phase maps to identify putative AF sources, then targeted for radiofrequency ablation, with adjunctive pulmonary vein isolation (PVI), if needed. All mapped rotors and/or sources were eliminated on the basis of repeated FIRM mapping. RESULTS: Of 47 patients, sustained AF was not present or induced in 4 patients who did not undergo FIRM ablation. Of the remaining 43 patients, prior AF was paroxysmal in 9 (21%) and 72% had a median of 1 prior PVI. Spontaneous AF (n = 22, 52%) and induced AF (n = 21, 49%) were mapped, and all patients had rotors identified (1.8 ± 0.8 per patient; 70% in the left atrium). AF termination occurred in 2 patients (5%) and none organized to atrial tachycardia. Touch-up redo PVI was also performed in 31 patients (72%). At 16.0 ± 10.7 months (range 1-34 months), only 9 patients (21%) were free of recurrent AF; and only 5 patients (12%) were free of AF and off antiarrhythmic drugs. CONCLUSION: Long-term clinical results after FIRM ablation in this diverse challenging cohort showed poor efficacy. Randomized clinical trials are needed to evaluate the efficacy and clinical utility of the FIRM ablation approach for treating AF.

Atrioesophageal fistula following ablation procedures for atrial fibrillation: systematic review of case reports.

BACKGROUND: Atrioesophageal fistula (AEF) is a rare but serious adverse event of atrial fibrillation (AF) ablation. OBJECTIVE: To identify the clinical characteristics of AEF following ablation procedures for AF and determine the associated mortality. METHODS: A systematic review of observational cases of AEF following ablation procedures for AF was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement protocol. RESULTS: 53 cases were identified. Mean age was 54±13 years; 73% (39/53) of cases occurred in males. Mean interval between procedure and presentation was 20±12 days, ranging from 2 to 60 days. AEF was observed in 12 patients who underwent surgical radiofrequency ablation (RFA) and in 41 patients with percutaneous RFA. Fever was the most common presenting symptom (n=44) followed by neurological deficits (n=27) and haematemesis (n=19). CT of the chest (n=27) was the preferred diagnostic test. Patients who did not receive a primary esophageal repair were more likely to have a deadly outcome (34% vs 83%; p<0.05). No difference in mortality rate was found between patients who underwent surgical RFA when compared with percutaneous RFA (58% vs 56%; p=0.579). No association was found between onset of symptoms and mortality (19±10 vs 23±14 days; p=0.355). CONCLUSIONS: AEF following ablation procedures for AF is a serious complication with high mortality rates. Presenting symptoms most often include a triad of fever, neurological deficit and/or haematemesis within 60 days of procedure. The preferred diagnostic test is CT of the chest. The treatments of choice is surgical repair.

Comparative safety of periablation anticoagulation strategies for atrial fibrillation: data from a large multicenter study.

BACKGROUND: There are a variety of periprocedural anticoagulation strategies for atrial fibrillation (AF) ablation, including the use of dabigatran. It is unclear which strategy is superior. OBJECTIVE: To compare the safety and efficacy of anticoagulation with uninterrupted warfarin, dabigatran, and warfarin with heparin bridging in patients undergoing ablation of AF at four experienced centers. METHODS AND RESULTS: In this retrospective analysis, 882 patients (mean age: 61 ± 11 years) underwent ablation of AF using uninterrupted warfarin (n = 276), dabigatran (n = 374), or warfarin with heparin bridging (n = 232) for periprocedural anticoagulation. The rate of total complications was 23/276 (8.3%) in the uninterrupted warfarin group, 30/374 (8.0%) in the dabigatran group, and 29/232 (12.5%) in the bridged group (P = 0.15). Major complications were more frequent in the uninterrupted warfarin group 12/276 (4.3%) compared with 3/374 (0.8%) in dabigatran and 6/232 (2.6%) in the bridged group (P = 0.01). The most common major complication was the need for transfusion or occurrence of major bleeding. Minor complications did not differ among the three groups. On multivariate analysis, female gender (odds ratio [OR] 1.93, confidence interval [CI] 1.16-3.19, P = 0.011), bridging heparin (OR 2.13, CI 1.100-3.941, P = 0.016), use of triple antithrombotic therapy (OR 1.77, CI 1.05-2.98, P = 0.033), and prior myocardial infarction (OR 2.40, CI 1.01-5.67, P = 0.046) independently predicted total complications. CONCLUSIONS: When comparing the use of uninterrupted warfarin, dabigatran, and warfarin with heparin bridging in patients undergoing catheter ablation of AF, dabigatran was not associated with increased risk, major complications were more common in the uninterrupted warfarin group, and after adjustment, warfarin with bridging increased total complications.

Very long-term outcome after initially successful catheter ablation of atrial fibrillation.

BACKGROUND: The ablation of atrial fibrillation (AF) using pulmonary vein isolation is indicated when patients do not respond favorably to medical therapy. Successful procedures are accomplished in the majority of patients, but the outcome after many years of follow-up after ablation is unknown. OBJECTIVE: To describe the long-term recurrence rate and pattern of AF after successful ablation. METHODS: A prospectively identified cohort of 445 patients who demonstrated freedom from AF for at least 1 year postablation (single procedure in 391 [87.9%]) was followed for 66.0 ± 34.0 months. Patients were seen at least annually as outpatients and underwent regular electrocardiographic monitoring. RESULTS: At 40.7 ± 27.0 months postablation, 97 (21.8%) patients experienced at least 1 episode of recurrent AF. The vast majority of events were symptomatic, and no serious clinical events were associated with AF recurrence (eg, stroke). There was a steady attrition rate reaching 16.3% and 29.8% at 5 and 10 years, respectively. In 29 patients (29.5%) of the patients, recurrences were self-limited; the remainder required either medical therapy or repeat ablation. By multivariate analysis, persistent AF (hazard ratio 3.08; P < .0001) and hypertension (hazard ratio 1.08; P = .009) were independent risk factors for the recurrence of AF. The presence of both factors placed the patient at high risk of recurrence: 37.6% at 5 years and 68.8% at 10 years. CONCLUSIONS: Over the decade after a successful ablation of AF, most patients continue to demonstrate freedom from AF. At the highest risk of very late recurrence is the subset of patients with hypertension and prior persistent AF.

Comparison of endovascular versus epicardial lead placement for resynchronization therapy.

Cardiac resynchronization therapy (CRT) has been shown to improve survival and symptoms in patients with severe left ventricular (LV) dysfunction, congestive heart failure, and prolonged QRS duration. LV lead placement is achieved by placing the lead in the coronary sinus, an endovascular approach, or by a minimally invasive robotic-assisted thoracoscopic epicardial approach. There are no data directly comparing the 2 methods. Patients eligible for CRT were randomized to the endovascular and epicardial arms. Coronary sinus lead placement was achieved using the standard technique, and epicardial leads were placed using a minimally invasive robotic-assisted thoracoscopic approach. The primary end point was a decrease in LV end-systolic volume index at 6 months. The secondary end points included 30-day mortality rate, measures of clinical improvement, 1-year electrical lead performance, and 1-year survival rate. The relative improvement of LV end-systolic volume index from baseline to 6 months was similar between the arms (28.8% for the transvenous [n = 12] vs 30.5% for the epicardial (n = 9) arm, p = 0.93). There were no significant differences in the secondary end points between the 2 groups. In conclusion, there were no differences in echocardiographic and clinical outcomes comparing a conventional endovascular approach versus robotic-assisted surgical epicardial LV lead placement for CRT in patients with heart failure. Surgical approaches are still a viable alternative when a transvenous procedure has failed or is not technically feasible.

Cardiac implantable electronic device infections: incidence, risk factors, and the effect of the AigisRx antibacterial envelope.

BACKGROUND: Cardiac implantable electronic device (CIED) infection is associated with morbidity and mortality. OBJECTIVES: To determine the incidence and risk factors for CIED infection, to develop a scoring index for risk stratification, and to analyze the effect of the AIGISRx envelope on infection rates. METHODS: Consecutive patients who underwent a CIED procedure were identified and surveyed for 6 months for the development of an infection necessitating removal of all implanted hardware. RESULTS: In the pre-envelope era, an infection occurred in 25 (1.5%) of 1651 patients. After its availability, an envelope was used in 275 (22%) of 1240 patients; an infection occurred in 8 (0.6%) patients in this era (P = .029 vs pre-envelope). In the overall cohort of 2891 patients, the infection rate was 1.2% and 3.5% in patients with an implantable cardioverter-defibrillator device and those with a cardiac resynchronization therapy defibrillator device, respectively (P = .018); in these patients, 7 independent risk factors predicted infection: early pocket re-exploration, male sex, diabetes, upgrade procedure, heart failure, hypertension, and glomerular filtration rate < 60 mL/min. A composite risk score (0-25; C index 0.72; 95% confidence interval 0.61-0.83) was created by weight, adjusting these 7 factors: 3 groups emerged-low risk (score 0-7; 1% infection), medium risk (score 8-14; 3.4% infection), and high risk (score ≥15; 11.1% infection). The envelope reduced infections by 79% and 100% in the medium- and high-risk groups, respectively. CONCLUSIONS: CIED infection most commonly occurred in patients with an implantable cardioverter-defibrillator device and those with a cardiac resynchronization therapy defibrillator device. A composite score based on clinical variables appeared feasible for infection risk stratification. The AIGISRx envelope significantly lowered the risk of CIED infection. Randomized clinical data are warranted.

Correlation of QT interval correction methods during atrial fibrillation and sinus rhythm.

The calculation of the corrected QT interval (QTc) is particularly problematic in patients during atrial fibrillation (AF). The aims of this study were to compare the QTc calculated using Bazett's formula in AF and sinus rhythm (SR) and determine whether alternative methods for QT correction were superior to Bazett's, in an effort to define the optimal method for QT correction in patients with AF. We evaluated consecutive patients with persistent AF admitted for initiation of dofetilide. The QT interval was corrected according to the following formulas: Bazett's, Fridericia, and Framingham. We compared the QTc interval on the last electrocardiogram in AF to the first electrocardiogram in SR. The cohort included 54 patients (age 60 ± 10 years, 80% men) with persistent AF for a median of 36 months. Bazett's overestimated QTc during AF compared with SR (464 ± 34 vs 445 ± 38 ms, p = 0.008); in contrast, Framingham underestimated it (385 ± 48 vs 431 ± 40 ms, p <0.001, respectively). However, there was no significant difference between the QTc interval in AF and SR when assessed by Fridericia (435 ± 33 vs 440 ± 35 ms, p = 0.46). There were 24 dofetilide dose reductions based on Bazett's QTc; this would have been avoided in 33% of patients had Fridericia been used. In conclusion, the commonly used Bazett's formula leads to an overestimation of the QTc during AF. This may result in unnecessary reduction in antiarrhythmic doses and thus drug efficacy. These data suggest that the Fridericia most closely approximates the QTc during AF to QTc during SR.

Long-term ECG monitoring using an implantable loop recorder for the detection of atrial fibrillation after cavotricuspid isthmus ablation in patients with atrial flutter.

BACKGROUND: In patients with atrial flutter who undergo cavotricuspid isthmus ablation, long-term electrocardiographic (ECG) monitoring may identify new onset of atrial fibrillation (AF). OBJECTIVES: To ascertain, through the use of an implantable loop recorder (ILR) with a dedicated AF detection algorithm, the incidence, duration, and burden of new AF in these patients and to develop an optimal postablation ECG monitoring strategy. METHODS: We enrolled 20 patients with flutter, a CHADS2 score of 2-3, and no prior episode of AF. After cavotricuspid isthmus ablation, we implanted an ILR, which was interrogated routinely; all stored ECGs were adjudicated. RESULTS: During a mean follow-up of 382 ± 218 days, 3 patterns were observed. First, in 11 (55%) patients, stored ECGs confirmed AF at 62 ± 38 days after ablation. Second, in 4 (20%) patients, although the ILR suggested AF, episodes actually represented sinus rhythm with frequent premature atrial contractions and/or oversensing. Third, in 5 (25%) patients, no AF was observed. Episodes <4 hours were associated with low AF burden (<1%) or false detections. The 1-year freedom from any episode of AF >4 and >12 hours was 52% and 83%, respectively. CONCLUSIONS: Our data show that many (but not all) patients develop new AF within the first 4 months of flutter ablation. Since external ECG monitoring for this duration is impractical, the ILR has an important role for long-term AF surveillance. Future research should be directed toward identifying the relationship between duration/burden of AF and stroke and improving existing ILR technology.

Dexmedetomidine sedation leading to refractory cardiogenic shock.

Dexmedetomidine is frequently used for deep sedation during electrophysiology procedures. We report a case where, presumably, the use of dexmedetomidine resulted in a patient's death. The patient developed unexplained and refractory cardiogenic shock and could not be resuscitated. Autopsy failed to demonstrate any abnormality or cause of death. We postulate that, in certain susceptible individuals, dexmedetomidine may lead to terminal complications. We therefore urge caution about using dexmedetomidine in the electrophysiology laboratory.

Long-term outcome following successful pulmonary vein isolation: pattern and prediction of very late recurrence.

BACKGROUND: Despite encouraging results of pulmonary vein isolation (PVI) ablation for atrial fibrillation (AF), it is unclear whether there is genuine cure or there is an important attrition rate. We sought to determine the long-term outcome of the initial responders who experienced a prolonged AF-free complete response. METHODS: From a series of 350 consecutive patients who underwent PVI for AF, 264 patients (75%) (males 71%, age 57 +/- 12 years, paroxysmal AF 87%) who demonstrated >or=1 year AF-free follow-up on no antiarrhythmic drugs were followed for 1-5 years. RESULTS: During 28 +/- 12 months follow-up, 23 of 264 (8.7%) patients had recurrence of AF. The actuarial recurrence at 2 years postablation was 5.8% and increased to 25.5% at 5 years. Compared with long-term responders, more patients with late recurrence had hypertension (HR = 2.18, P = 0.009) and hyperlipidemia (HR = 4.01, P = 0.0005). Among 18 patients with recurrent AF necessitating repeat PVI, 15 (83%) required re-isolation of > 1 PV and 28 of 45 (58%) PVs showed reconnection. All PVs were re-isolated and five (28%) patients had additional linear ablation. All 15 patients became AF-free again. CONCLUSIONS: Although most patients following PVI remain AF-free, some patients develop "late" recurrence of AF. The "late" recurrence patients are more likely to have hypertension and hyperlipidemia. Most late recurrences are associated with PV reconnections. Our observations emphasize the importance of continued long-term vigilance for AF recurrence, and also raise concerns regarding the need for long-term anticoagulation therapy.

Impact of systemic hypertension on the cardiovascular benefits of statin therapy--a meta-analysis.

The ASCOT-LLA and ALLHAT-LLT trials provide conflicting evidence of the efficacy of statins in decreasing cardiovascular (CV) morbidity and mortality in hypertensive patients. We performed a meta-analysis to compare the overall efficacy of statins in hypertensive and nonhypertensive patients enrolled in major randomized clinical trials. We systematically reviewed PubMed publications from 1985 onward for placebo-controlled randomized trials that examined the effect of statins on cardiac morbidity and mortality. Only trials that followed >or=1,000 patients for >or=2 years were included in the meta-analysis. Outcomes included cardiac or CV death, major coronary events, or major CV events. Pooled estimates of relative risk (RR) were calculated separately for hypertensive and nonhypertensive patients. The moderating effect of the percentage of hypertensive patients at baseline was tested using meta-regression. Besides the ASCOT-LLA and ALLHAT-LLT, 12 trials enrolling 69,984 patients met inclusion criteria. Overall, in these 12 trials, statin therapy decreased cardiac death by 24% (RR 0.76, 95% confidence interval [CI] 0.71 to 0.82). There was no evidence of difference in RR estimates for hypertensive (RR 0.78, 95% CI 0.72 to 0.84) and nonhypertensive (RR 0.76, 95% CI 0.72 to 0.80) patients. Similarly, meta-regression showed that the efficacy of statins was not moderated by the percentage of hypertensive patients at baseline (Q estimate 1.51, p=0.22). In conclusion, statin therapy effectively decreases CV morbidity and mortality to the same extent in hypertensive and nonhypertensive patients.