Percutaneous mitral annuloplasty with the Carillon device: Outcomes in proportionate and disproportionate functional mitral regurgitation.

BACKGROUND: It has been suggested that the disparity of outcomes between the studies of transcutaneous edge-to-edge repair (TEER) for functional mitral regurgitation (FMR) in heart failure with reduced ejection fraction (HFrEF) could be due to systematic differences in the populations studied. One proposal is that there are 2 broad groups: those with proportional FMR who respond less favorably, and those in whom the FMR is greater than expected (disproportionate) FMR where edge-to-edge TEER seems to be more effective. Whether this grouping is relevant for other percutaneous interventions for FMR is unknown. OBJECTIVES: We sought to compare clinical and echocardiographic outcomes of patients with HFrEF and proportionate and disproportionate FMR treated with indirect annuloplasty using the Carillon device. METHODS: This is a pooled analysis from 3 trials of patients with FMR. Key patient eligibility in these trials specified persistent grade 2+ to 4+ FMR with >5.5 cm left ventricular (LV) end-diastolic diameter (LVEDD) and reduced ejection fraction. Patients with an effective regurgitant orifice area/LV end-diastolic volume (EROA/LVEDV) ratio under 0.15 were assigned to the proportionate FMR group (n = 74;65%) and those with a ratio above 0.15 were classed as having disproportionate FMR (n = 39;35%). RESULTS: At 12 months following treatment, both groups showed improvements in all MR variables including regurgitation volume, EROA and vena contracta. Moreover, in patients with proportionate MR there were clinically relevant and statistically significant improvements in LV volumes and diameters. There was no independent relationship between the degree of proportionality as a continuous variable and the remodeling response to Carillon therapy (change in LVEDV r = 0.17; change in LVESV r = 0.14). CONCLUSION: Percutaneous mitral annuloplasty with the Carillon device reduces MR in patients with both proportionate and disproportionate FMR, and also results in LV reverse remodeling in those with proportionate FMR. The effect on remodeling remains to be verified in a large-scale trial.

Treating symptoms and reversing remodelling: clinical and echocardiographic 1-year outcomes with percutaneous mitral annuloplasty for mild to moderate secondary mitral regurgitation.

AIMS: To determine the effects of percutaneous mitral annuloplasty on symptoms, walk distance and left ventricular (LV) structure and function in patients with mild or moderate secondary mitral regurgitation (SMR). METHODS AND RESULTS: This was a pooled analysis of patients (n = 68) who, despite guideline-directed medical therapy had symptomatic heart failure (HF) with mild (n = 25) or moderate (n = 43) SMR treated with percutaneous mitral annuloplasty as part of the TITAN, TITAN II, or REDUCE-FMR trials. Primary outcomes were changes in symptoms, 6-min walk distance, and quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) after 1 year. Secondary analyses included changes in LV structure and function. At 1 year, New York Heart Association class status was maintained (48%) or improved (46%) in most patients, mean KCCQ scores increased from baseline by 10 units [95% confidence interval (CI) 3 to17; P < 0.01] and mean 6-min walk test distance increased by 34 m (95% CI 12 to 57; P < 0.01). SMR grade improved in 25% of patients and was maintained in 58% of patients with changes in mean regurgitant volume of -7 mL (95% CI -11 to -3; P < 0.001), vena contracta -0.11 cm (95% CI -0.20 to -0.02; P < 0.05), and effective regurgitant orifice area -0.03 cm2 (95% CI -0.06 to -0.01; P < 0.05). There were non-significant improvements in LV ejection fraction and volumes. Survival over 1 year was 89% with no difference between mild (96%) and moderate (86%) SMR (log-rank P = 0.22). Progression-free survival was 70% (82% in mild vs. 63% in moderate SMR; P = 0.16). Freedom from HF hospitalization was 73% (87% in mild SMR vs. 66% in moderate SMR; P = 0.07). CONCLUSION: Among patients with symptomatic HF and mild or moderate SMR on guideline-directed medical therapy, percutaneous mitral annuloplasty was associated with improvements in symptoms, SMR, a stabilization of LV structure and function, and high survival rates.

Electrocardiographic criteria for anterior STEMI - Does the cut-off point affect treatment delay?

BACKGROUND: Diagnostic criteria for anterior STEMI differ between the European Society of Cardiology (ESC) and the European Resuscitation Council (ERC). A greater degree of ST-segment elevation is required to meet ERC criteria compared to ESC criteria. This may potentially lead to discrepancies in management between emergency teams and cardiologists, subsequent delay in reperfusion therapy and worse prognosis. METHODS: We performed an observational study in patients with anterior STEMI routinely treated with primary PCI and assessed whether differing electrocardiographic diagnostic criteria could impact treatment and short-term prognosis. All patients in the study had anterior STEMI confirmed by electrocardiographic ESC criteria and subsequent coronary angiography. Patients were divided into two groups. Those who did not meet ERC criteria in the index ECG were assigned to the "non-ERC" group and were compared with those who met them - the "ERC" group. RESULTS: Out of 60 patients with anterior STEMI based on ESC criteria (mean age 66.9 ± 13.6 years, 70% males), 26 patients (44%) did not meet ERC criteria ("non-ERC" group) for STEMI. There were no significant differences in age, gender distribution or clinical characteristics between "ERC" and "non-ERC" patients. Total-Ischemic-Time, Patient-Delay, and System-Delay times were significantly longer in "non-ERC" group (433.1 ± 389.9 min vs. 264.2 ± 229.6 min, p = 0.03; 290.8 ± 337.6 min vs. 129.5 ± 144.9 min; p < 0.05 and 158.8 ± 158 vs 134.6 ± 191 min, p < 0.02 respectively). There were no differences in In-Hospital-Delay, procedure duration, and success rate of PCI. Proximal LAD occlusion (64.7%) and TIMI = 0 flow (73.5%) tended to be more frequently observed in "ERC" than in the "non-ERC" group (53.8% and 65.4%, respectively). Hospitalization time and LVEF (44.4 ± 8.7 vs 42.8 ± 9.5%, p = 0.53) were similar between groups. CONCLUSIONS: Differences in electrocardiographic criteria for anterior STEMI leave a significant proportion of patients undiagnosed. Patients with STEMI who failed to meet less strict ERC criteria had more distal LAD disease with better TIMI flow but received reperfusion therapy later. Thus, character of the disease may compensate for treatment delay but this needs to be further evaluated. Finally, lowering the cut-off point with stricter criteria compromises specificity and is expected to increase the false positive rate, however there were no false positives in this study as all patients were angiographically confirmed to have acute coronary obstruction.

Transcatheter treatment of functional mitral valve regurgitation.

Functional mitral regurgitation is a clinical entity with increasing prevalence and significant impact on morbidity and mortality. Because of the unsatisfactory results of medical therapy and high perioperative risk resulting in low referral/high denial rates for surgical treatment, benefits of which still remain controversial, novel minimally invasive transcatheter techniques are under development. Herein, in the present review, we discuss the recent progress in the emerging field of catheter-based techniques for functional mitral regurgitation.

Long-term prognosis of patients treated by coronary sinus-based percutaneous annuloplasty: single centre experience.

AIMS: This study aims to report long-term mortality, echocardiographic, and clinical outcomes of patients receiving treatment for functional mitral regurgitation (FMR) with the Carillon device. METHODS AND RESULTS: This was a single centre analysis of prospectively collected data from patients treated with the Carillon Mitral Contour System for symptomatic congestive heart failure despite guideline-directed medical therapy, who were included from a single centre from the TITAN II study. All patients presented with New York Heart Association (NYHA) class 2 or greater symptoms, grade 2+ to 4+ FMR, left ventricular enlargement, and reduced ejection fraction. Surviving patients were evaluated for long-term follow-up post-procedure, averaging 6.9 years. Fifteen (15) patients (mean age 72 years, 60% male, 100% NYHA class III or IV, 50% MR grade 3+ or 4+) were treated with the Carillon device. The Kaplan-Meier mortality rate was 40% at 6 years of follow-up. Long-term survival through 6 years was associated with echocardiographic improvement in mitral regurgitation (change in effective regurgitant orifice area in survivors versus non-survivors from baseline to 1 year follow-up, -9.0 ± 5.6 vs. -1.7 ± 1.5, P = 0.02) and clinical status at 12 months (difference in NYHA at 1 year follow-up between survivors versus non-survivors, P = 0. 05) which was sustained throughout follow-up. All patients at 6 year follow-up had ≤2+ MR, with 6 of 7 having 0-1+ MR. Left ventricular end-diastolic volume was reduced from 154.0 ± 65.7 mL at baseline to 104.5 ± 59.2 mL at 6 year follow-up, P = 0.03 in survivors with both measurements. CONCLUSIONS: Among patients with congestive heart failure treated with the Carillon device, long-term survival is associated with favourable 1 year and sustained improvements in mitral regurgitation, left ventricular volume, ejection fraction, and clinical status.

Long-Term Survival Following Transcatheter Mitral Valve Repair: Pooled Analysis of Prospective Trials with the Carillon Device.

PURPOSE: To report long-term survival and to identify potential determinants of survival among patients receiving treatment for functional mitral regurgitation (FMR) with the Carillon device. METHODS: This was a post hoc analysis in which we pooled prospectively collected data from three studies of the Carillon device with available long-term vital status data. Patient eligibility in these trials specified symptomatic congestive heart failure despite guideline-directed medical therapy, grade 2 to 4 FMR, left ventricular enlargement, and reduced ejection fraction. Echocardiographic parameters were available through the 12-month visit and vital status was available through 5 years. The association of patient characteristics and changes in echocardiographic parameters at 6 and 12 months with long-term survival was analyzed using Cox proportional hazards regression. RESULTS: A total of 74 patients (mean age 67 years, 72% male, 59% MR grade 3 or 4) were treated with the Carillon device. Over 1 year of follow-up, the New York Heart Association (NYHA) class decreased in 64% of patients, distance on the 6-minute walk test increased, and echocardiographic measures indicated significant decreases in MR grade and favorable left ventricular remodeling. The Kaplan-Meier survival rate was 83.6% at 1 year, 73.1% at 2 years, 67.9% at 3 years, and 56.2% at 4 and 5 years of follow-up. Primary determinants of long-term survival were a decrease in NYHA class, an increase in 6-minute walk test distance, and a decrease in regurgitant volume during the first year of follow-up. CONCLUSIONS: Among patients with congestive heart failure and grade 2 to 4 FMR who were symptomatic despite guideline-directed medical therapy, transcatheter mitral valve repair with the Carillon device resulted in a favorable 5-year survival rate. The survival benefit was greatest among patients with improvement in clinical and hemodynamic parameters during the first year of follow-up.

The REDUCE FMR Trial: A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation.

OBJECTIVES: This study sought to evaluate the effects of the Carillon device on mitral regurgitation severity and left ventricular remodeling. BACKGROUND: Functional mitral regurgitation (FMR) complicates heart failure with reduced ejection fraction and is associated with a poor prognosis. METHODS: In this blinded, randomized, proof-of-concept, sham-controlled trial, 120 patients receiving optimal heart failure medical therapy were assigned to a coronary sinus-based mitral annular reduction approach for FMR or sham. The pre-specified primary endpoint was change in mitral regurgitant volume at 12 months, measured by quantitative echocardiography according to an intention-to-treat analysis. RESULTS: Patients (69.8 ± 9.5 years of age) were randomized to either the treatment (n = 87) or the sham-controlled (n = 33) arm. There were no significant differences in baseline characteristics between the groups. In the treatment group, 73 of 87 (84%) had the device implanted. The primary endpoint was met, with a statistically significant reduction in mitral regurgitant volume in the treatment group compared to the control group (decrease of 7.1 ml/beat [95% confidence interval [CI]: -11.7 to -2.5] vs. an increase of 3.3 ml/beat [95% CI: -6.0 to 12.6], respectively; p = 0.049). Additionally, there was a significant reduction in left ventricular volumes in patients receiving the device versus those in the control group (left ventricular end-diastolic volume decrease of 10.4 ml [95% CI: -18.5 to -2.4] vs. an increase of 6.5 ml [95% CI: -5.1 to 18.2]; p = 0.03 and left ventricular end-systolic volume decrease of 6.2 ml [95% CI: -12.8 to 0.4] vs. an increase of 6.1 ml [95% CI: -1.42 to 13.6]; p = 0.04). CONCLUSIONS: The Carillon device significantly reduced mitral regurgitant volume and left ventricular volumes in symptomatic patients with functional mitral regurgitation receiving optimal medical therapy. (Carillon Mitral Contour System for Reducing Functional Mitral Regurgitation [REDUCE FMR]; NCT02325830).

Emergency treatment of iatrogenic coronary perforation by transcatheter embolization with gelatin sponge particles-Description of technique.

Coronary artery perforation (CAP) is a rare but potentially life-threatening complication of percutaneous coronary intervention (PCI) that requires prompt diagnosis and effective treatment. Importantly, dynamic advances in interventional cardiology reflected by the increasing percentage of more challenging PCIs performed in more complex lesions have resulted in significant changes in CAPs pattern. Herein, we describe a technique and present a case report of CAP that occurred during percutaneous recanalization of the occluded restenotic right coronary artery (RCA) successfully treated with transcatheter embolization using gelatin sponge particles prepared on-site. The patient underwent coronary angiography with a subsequent attempt to open chronically occluded RCA. During the procedure, a guidewire was inadvertently positioned outside the arterial bed resulting in type III CAP. After unsuccessful prolonged balloon inflations as well as an anticoagulation reversal, embolization of the RCA with gelatin sponge particles as an ultima ratio treatment was performed. Sponge particles were prepared on-site by the operator, by cutting gelatin sponge used for wound healing. The procedure resulted in a total occlusion of the RCA and significant clinical improvement. The patient did not require pericardiocentesis and was discharged from the hospital after 10 days of an uneventful postprocedural course. The described technique is an easy and effective method of guidewire-related CAPs treatment in whom stent grafts cannot be implanted. Noteworthy, the technique can be applied in most cath labs as it utilizes a widely available gelatin sponge and does not require any specific expertise.

Impact of previous percutaneous coronary interventions on the course and clinical outcomes of coronary artery bypass grafting.

BACKGROUND: Despite the increasing number of patients after percutaneous coronary intervention (PCI) requiring coronary artery bypass grafting (CABG), studies on the impact of these procedures on surgical revascularisation outcomes are sparse. Furthermore, advances in cardiology require reassessment of their potential prognostic significance. AIM: We sought to assess the influence of previous PCI on CABG outcomes. METHODS: A total of 211 consecutive patients scheduled for CABG were enrolled into this prospective study. Patients after PCI (group 1, n = 99) were compared with subjects with no history of PCI (group 2, n = 112) in terms of preoperative, operative, and postoperative data. All the patients were followed-up for the incidence of in-hospital (cardiogenic shock, myocardial infarction, stroke, acute renal failure, reoperation, death) and long-term (overall mortality, occlusion of at least one graft in 64-row computed tomography) clinical endpoints. RESULTS: Group 1 had more advanced heart failure and coronary artery disease as reflected by New York Heart Association (2.43 ± 0.57 vs. 2.17 ± 0.68; p < 0.001) and Canadian Cardiovascular Society (2.44 ± 0.59 vs. 2.03 ± 0.65; p < 0.001) scales, respectively. Compared with group 2, longer aortic cross-clamp (33.5 ± 9.9 vs. 29.5 ± 8.4; p < 0.05) and cardiopul-monary bypass (67.5 ± 28.2 vs. 56.5 ± 17.9; p < 0.001) times were observed as well as a higher number of implanted grafts (3.0 ± 0.7 vs. 2.8 ± 0.70; p < 0.05). No significant differences were observed in terms of in-hospital clinical endpoints. During 12 ± 3.41 months of follow-up group 1 had higher mortality (5.05% vs. 0%; p < 0.05) but similar graft patency. CONCLUSIONS: "Stent-loaded" patients undergo more time-consuming CABG with a higher number of grafts. Furthermore, they have higher long-term mortality but similar graft patency and in-hospital mortality/morbidity.

A randomized double-blind trial of an interventional device treatment of functional mitral regurgitation in patients with symptomatic congestive heart failure-Trial design of the REDUCE FMR study.

The Carillon Mitral Contour System has been studied in 3 nonrandomized trials in patients with symptomatic congestive heart failure and functional mitral regurgitation. The REDUCE FMR study is a uniquely designed, double-blind trial evaluating the impact of the Carillon device on reducing regurgitant volume, as well as assessing the safety and clinical efficacy of this device. Carillon is a coronary sinus-based indirect annuloplasty device. Eligible patients undergo an invasive venogram to assess coronary sinus vein suitability for the Carillon device. If the venous dimensions are suitable, they are randomized on a 3:1 basis to receive a device or not. Patients and assessors are blinded to the treatment assignment. The primary end point is the difference in regurgitant volume at 1 year between the implanted and nonimplanted groups. Other comparisons include clinical parameters such as heart failure hospitalizations, 6-minute walk test, Kansas City Cardiomyopathy Questionnaire (KCCQ), and other echocardiographic parameters. An exercise echo substudy will also be included.

Cath lab costs in patients undergoing percutaneous coronary angioplasty - detailed analysis of consecutive procedures.

BACKGROUND: Costs of percutaneous coronary interventions (PCI) have an important impact on health care expenditures. Despite the present stress upon the cost-effectiveness issues in medicine, few comprehensive data exist on costs and resource use in different clinical settings. AIM: To assess catheterisation laboratory costs related to use of drugs and single-use devices in patients undergoing PCI due to coronary artery disease. METHODS: Retrospective analysis of 1500 consecutive PCIs (radial approach, n = 1103; femoral approach, n = 397) performed due to ST segment elevation myocardial infarction (STEMI; n = 345) and non ST-segment elevation myocardial infarction (NSTEMI; n = 426) as well as unstable angina (UA; n = 489) and stable angina (SA; n = 241) was undertaken. Comparative cost analysis was performed and shown in local currency units (PLN). RESULTS: The cath lab costs were higher in STEMI (4295.01 ± 2384.54PLN, p < 0.001) compared to NSTEMI (3493.40 ± 1907.43 PLN, p < 0.001), UA (3206.31 ± 1692.82 PLN, p < 0.001) and SA patients (3138.91 ± 1427.62 PLN, p < 0.001). They were higher in males than in females (3668.9 ± 2095.2 vs. 3292.0 ± 1656.0 PLN, p < 0.05). In females PCIs performed via radial approach were more expensive than via femoral approach (3360.4 ± 1540.1 vs. 3135.5 ± 1890.3 PLN, p < 0.01). In all subgroups analysed, costs were positively correlated with X-ray dose, fluoroscopy, and total procedure times. Patients' age negatively correlated with cath lab costs in STEMI/NSTEMI patients. CONCLUSIONS: Cath lab costs were higher in STEMI patients compared to other groups. In STEMI/NSTEMI they were lower in older patients. In all analysed groups costs were related to the level of procedural difficulty. In female patients, the costs of PCI performed via radial approach were higher compared to femoral approach. Despite younger age, male patients underwent more expensive procedures.

Evaluation of radiological risk during coronary angioplasty procedures: comparison of transradial and transfemoral approaches.

Increasing operator experience and newer available interventional cardiology devices require reassessment of radiological risk related to percutaneous coronary interventions (PCI). We aimed at comparison of radiological risk and procedural data of PCIs performed by radial (RA) and femoral (FA) approach in real life patients. Detailed retrospective analysis of 1500 consecutive PCIs with the use of radial or femoral access was performed. Comparison between RA and FA groups included procedural time (PT), fluoroscopy time (FT), radiation dose and contrast volume usage. There was no significant differences between RA and FA procedures in FT (12.6 ± 13.5 vs. 11.7 ± 9.5 min), X-ray dose generated during PCI (805.9 ± 615.9 vs. 792.2 ± 633.9 mGy) and use of contrast medium (145.2 ± 62.2 vs. 152.5 ± 64.2 ml). Mean total PT was shorter in RA (43.7 ± 24.5 min) than in FA group (47.2 ± 30.13 min, p < 0.02). Patients' age positively correlated with FT (r = 0.14, p < 0.05) and PT (r = 0.07, p < 0.05) in RA but not in FA group (r = 0.05; r = -0.06, respectively). Despite younger age, PCIs in males needed higher usage of contrast medium (151.7 ± 69.2 vs. 139.1 ± 49.3 ml; p < 0.001), and higher X-ray dose (887.0 ± 660.4 vs. 657.8 ± 515.2 mGy; p < 0.001). Age significantly correlated with PT only in female (r = 0.093, p < 0.05) but not in male patients (r = 0.015). We conclude that fluoroscopy times, X-ray dose and use of contrast medium were similar in RA and FA, but mean total procedural time was significantly shorter in RA than in FA group. However, older patients in RA group needed longer fluoroscopy and procedural times to complete PCI and this was not seen in FA.

Percutaneous Trans-Coronary Venous Mitral Annuloplasty in Patients With Functional Mitral Regurgitation: Analysis of Poznan Carillon Registry Data.

OBJECTIVES: The purpose of our study is to verify, whether percutaneous mitral annuloplasty results in reverse remodeling in patients with functional mitral regurgitation (FMR) and impaired ejection fraction (EF) and to investigate which echo parameters may help in prediction of the efficacy of the procedure. BACKGROUND: FMR exacerbates left ventricular (LV) dilatation and contributes to both LV remodeling and heart failure. METHODS: We analyzed baseline and 1 month follow-up data in 22 consecutive patients with FMR, who underwent successful percutaneous trans-coronary venous mitral annuloplasty with the Carillon device. RESULTS: Significant reduction of FMR echo parameters, including vena contracta (VC), effective regurgitant orifice area (EROA), and regurgitant volume (RV) were observed and maintained throughout 1 month follow up and did not correlate with baseline annular, LV or with the left atrial diameters. Baseline mitral tenting area correlated negatively with the relative improvement (% difference) of EROA (r = -0.5898) and RV (r = -0.4363), but not with VC (r = 0.1341). In addition, increased EF as well as a significant reduction in left ventricular diameters were noted. The increase in EF negatively correlated with the change in EROA (r = -0.50058), PISA (r = -0.5327), and RV (r = -0.5457). Baseline mitral tenting area significantly correlated with the 1 month change in EF (r = 0.5946) and stroke volume (r = 0.6913). CONCLUSIONS: The improvement of FMR after treatment with the Carillon device is associated with LV reverse remodeling and an increase in systolic performance, that correlates with the reduction in mitral regurgitation, being not dependent on baseline heart diameters. Mitral tenting area seems to be an important parameter in prediction of benefit from percutaneous mitral annuloplasty.

Bipolar irrigated radiofrequency ablation of resistant ventricular tachycardia with a septal intramural origin: the initial experience and a description of the method.

Bipolar radiofrequency (RF) ablation is effective in treatment of ventricular tachycardia originating from thick interventricular septum. The RF generator and CARTO system can be used to precisely and safely perform ablation. Standard ablation catheter can be used with indifferent ablation electrode connected to the electrode receptacle in RF generator with custom-made cable.

Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial.

OBJECTIVE: Functional (or secondary) mitral regurgitation (FMR) is associated with greater morbidity and worse outcomes in patients with congestive heart failure (CHF) and cardiomyopathy. The Carillon® Mitral Contour System® is a coronary sinus-based percutaneous therapy to reduce FMR. We evaluated the safety and efficacy of a modified version of the Carillon device in the treatment of patients with cardiomyopathy and FMR. METHODS: 36 patients with CHF, depressed left ventricular function (ejection fraction <40%) and at least moderate FMR underwent the Carillon device implant. RESULTS: There was 1 major adverse event within 30 days-a death (not device related)-occurring 17 days after the implant. Reductions in FMR and improvements in functional class and 6 min walk tests were seen, similar to prior studies. Device fractures in the high strain region of the proximal anchor (seen in prior studies) were not seen in this study. CONCLUSIONS: The modified Carillon device was associated with improvements in clinical and echocardiographic parameters in treating patients with FMR, while successfully addressing the issue of anchor fracture. This version of the Carillon device will be used in a blinded randomised trial of symptomatic patients with FMR.

Comparison of Baseline Heart Rate Variability in Stable Ischemic Heart Disease Patients with and without Stroke in Long-Term Observation.

GOAL: Decreased heart rate variability (HRV) has predictive value in postinfarction as well as in ischemic stroke patients. However, it is unknown if ischemic heart disease (IHD) patients who are at high risk of stroke have different HRV profile. The goal of this study was to compare baseline HRV (traditional and novel indices) in stable IHD patients with and without stroke in long-term observation. METHODS: A total of 139 consecutive patients with stable IHD scheduled for coronary angiography were enrolled. Five-minute electrocardiogram readings were taken. Traditional and novel HRV measures were calculated. After 70.06 ± 4.297 months of follow-up, baseline HRV indices in patients who had had a stroke were compared with indices in patients without the aforementioned cerebrovascular event. RESULTS: During follow-up, 6 patients developed stroke. Compared to patients without such a cerebrovascular event, these patients with stroke had lower values for the following HRV indices: de Hann long-term irregularity (30,521 ± 32,767 versus 46,678 ± 25,328; P < .05), Yeh interval index (.0207 ± .0208 versus .0326 ± .0157; P < .05), Organ BAND (3.0563 ± 3.328 versus 4.515 ± 2.276; P < .05), Dalton standard deviation (SD) (17,887 ± 17,636 versus 29,859 ± 16,478; P < .05), Zugaib short-term variability (.004 ± .00416 versus .00622 ± .00418; P < .05), Zugaib long-term variability (.0161 ± .0151 versus .0247 ± .0115; P < .05), standard deviation of all NN intervals (8,954 ± 8,812 versus 16,724 ± 11,594; P < .05), total power (2,616 ± 4,855 versus 4,678 ± 4,653; P < .05), w2 (.71 ± .338 versus 1.719 ± 1.08; P < .05), w3 (1.399 ± .924 versus 2.552 ± 1.609; P < .05), and w4 (1.367 ± 1.705 versus 2.824 ± 2.027; P < .05). No significant differences in other analyzed indices were observed. CONCLUSIONS: Patients with IHD and stroke in long-term observation have different baseline profiles of HRV indices. Further investigations are needed to assess the usefulness of HRV analysis in stroke risk assessment.