Effect of ICD Therapies on Mortality in the OMNI Trial.

BACKGROUND: Analyses from primary prevention trials on implantable cardioverter defibrillator (ICD) therapy have shown an association between shocks and increased mortality. Recent data suggest a similar association with antitachycardia pacing (ATP). OBJECTIVE: The OMNI study is an observational study of pacemaker and ICD use. We aim to examine associations between ICD therapies and mortality in this setting. METHODS: A total of 2,255 OMNI patients with ICDs were included. Treated episodes were classified as appropriate or inappropriate. Patients were assigned into 1 of 3 groups depending on whether the episode required ATP only, single shock, or multiple shocks, and then followed for all-cause mortality. Additionally, we aimed to determine the frequency with which inappropriate ATP precipitated ventricular arrhythmias that led to shock, since this has been suggested as a mechanism of harm. RESULTS: Over a mean follow-up of 39 ± 19 months, there were a total of 470 deaths (21%). Compared to patients with no treated episodes, patients with appropriate therapy had greater risk of death. Hazard ratios were 1.46 (95% confidence interval [CI] 1.05-2.02; P = 0.023) for the ATP-only group, 2.11 (95% CI 1.51-2.96; P < 0.001) for the single-shock group, and 2.55 (95% CI 1.43-4.57; P = 0.002) for the multishock group. There was no significant association between any type of inappropriate therapy and increased mortality. We identified only 7 instances of inappropriate ATP precipitating ventricular arrhythmia resulting in shock. CONCLUSIONS: Patients receiving appropriate therapy of all types had increased mortality compared to those with no episodes. Furthermore, inappropriate ATP rarely precipitates ventricular arrhythmias.

Outcomes after atrioventricular node ablation and biventricular pacing in patients with refractory atrial fibrillation and heart failure: a comparison between non-ischaemic and ischaemic cardiomyopathy.

AIMS: Atrioventricular junction ablation (AVJA) combined with biventricular (BiV) pacing (AVJA/BiV) is an effective treatment for refractory atrial fibrillation (AF) and rapid ventricular response (RVR) associated with heart failure (HF). This study compared the outcomes between patients with non-ischaemic (DCM) and ischaemic cardiomyopathy (ICM) following AVJA/BiV for AF/RVR. METHODS AND RESULTS: This was a retrospective study of 45 patients, comparing the response to AVJA/BiV in patients with ICM to those with DCM. The study compared (a) the change in echocardiographic parameters of HF (ejection fraction (EF) and left ventricular dimensions) prior to, and at least 6 months post AVJA/BiV; and (b) HF hospitalizations (HFH) and appropriate implantable cardioverter defibrillator (ICD) therapies occurring post-procedure. Ejection fraction improved significantly in the DCM group (ΔEF 11.2% ± 11.9; P< 0.01); however, EF remained unchanged (ΔEF 0.5% ± 9.9; P = NS) in the ICM group post-AVJA/BiV. Post-procedurely, HFH were significantly more common (15/18 vs. 4/25; P < 0.0001), and there were significantly more appropriate ICD therapies (9.4 ± 12.3 vs. 2.3 ± 6.1; P = 0.01) in the ICM compared with the DCM group. CONCLUSION: After AVJA/BiV, there was significantly less post-procedural echocardiographic reverse remodelling, and more HFH in the ICM compared with the DCM group. In addition, significantly more appropriate ICD therapies occurred in ICM patients post-procedure. These differences may be due to the presence of more extensive discrete myocardial scar in patients with ICM. Furthermore, it is possible that tachycardia-induced cardiomyopathy plays more of a causative role in HF in patients with AF and DCM than those with ICM.

A randomized controlled trial evaluating the safety and efficacy of cardiac contractility modulation in advanced heart failure.

BACKGROUND: Cardiac contractility modulation (CCM) delivers nonexcitatory electrical signals to the heart during the absolute refractory period intended to improve contraction. METHODS: We tested CCM in 428 New York Heart Association class III or IV, narrow QRS heart failure patients with ejection fraction (EF) ≤ 35% randomized to optimal medical therapy (OMT) plus CCM (n = 215) versus OMT alone (n = 213). Efficacy was assessed by ventilatory anaerobic threshold (VAT), primary end point, peak Vo2 (pVo2), and Minnesota Living with Heart Failure Questionnaire (MLWFQ) at 6 months. The primary safety end point was a test of noninferiority between groups at 12 months for the composite of all-cause mortality and hospitalizations (12.5% allowable delta). RESULTS: The groups were comparable for age (58 ± 13 vs 59 ± 12 years), EF (26% ± 7% vs 26% ± 7%), pVo2 (14.7 ± 2.9 vs 14.8 ± 3.2 mL kg⁻¹ min⁻¹), and other characteristics. While VAT did not improve at 6 months, CCM significantly improved pVo2 and MLWHFQ (by 0.65 mL kg⁻¹ min⁻¹ [P = .024] and -9.7 points [P < .0001], respectively) over OMT. Forty-eight percent of OMT and 52% of CCM patients experienced a safety end point, which satisfied the noniferiority criterion (P = .03). Post hoc, hypothesis-generating analysis identified a subgroup (characterized by baseline EF ≥ 25% and New York Heart Association class III symptoms) in which all parameters were improved by CCM. CONCLUSIONS: In the overall target population, CCM did not improve VAT (the primary end point) but did improve pVo2 and MLWHFQ. Cardiac contractility modulation did not have an adverse affect on hospitalizations or mortality within the prespecified boundaries. Further study is required to clarify the role of CCM as a treatment for medically refractory heart failure.

Subgroup analysis of a randomized controlled trial evaluating the safety and efficacy of cardiac contractility modulation in advanced heart failure.

BACKGROUND: Cardiac contractility modulation (CCM) signals are nonexcitatory electrical signals delivered during the absolute refractory period intended to improve contraction. We previously tested the safety and efficacy of CCM in 428 NYHA functional class III/IV heart failure patients with EF ≤35% and narrow QRS randomized to optimal medical treatment (OMT) plus CCM (n = 215) versus OMT alone (n = 213) and found no significant effect on ventilatory anaerobic threshold (VAT), the study's primary end point. In the present analysis, we sought to identify if there was a subgroup of patients who showed a response to CCM. METHODS AND RESULTS: The protocol specified that multiregression analysis would be used to determine if baseline EF, NYHA functional class, pVO(2), or etiology of heart failure influenced the impact of CCM on AT. Etiology and baseline pVO(2) did not affect efficacy. However, baseline NYHA functional class III and EF ≥25% were significant predictors of increased efficacy. In this subgroup (comprising 97 OMT and 109 CCM patients, ∼48% of the entire population) VAT increased by 0.10 ± 2.36 in CCM versus -0.54 ± 1.83 mL kg(-1) min(-1) in OMT (P = .03) and pVO(2) increased by 0.34 ± 3.11 in CCM versus -0.97 ± 2.31 (P = .001) at 24 weeks compared with baseline; 44% of CCM versus 23% of OMT subjects showed improvement of ≥1 class in NYHA functional class (P = .002), and 59% of CCM versus 42% of OMT subjects showed a ≥10-point reduction in Minnesota Living with Heart Failure Questionnaire (P = .01). All of these findings were similar to those seen at 50 weeks. CONCLUSIONS: The results of this retrospective hypothesis-generating analysis indicate that CCM significantly improves objective parameters of exercise tolerance in a subgroup of patients characterized by normal QRS duration, NYHA functional class III symptoms, and EF >25%.

Preventing shoulder pain after cardiac rhythm management device implantation: a randomized, controlled study.

INTRODUCTION: Shoulder pain and disability ipsilateral to the implant site is a common complication of cardiac rhythm device implantation, yet very little has been published about this morbidity. We designed a study to assess the potential benefit of a simple exercise protocol in preventing shoulder pain postoperatively. METHODS AND RESULTS: Patients undergoing subcutaneous device implantation were randomized to one of two groups. The control group received standard instructions, whereas the exercise group was instructed on specific exercises aimed at strengthening or stretching the shoulder girdle, to be completed 3 days per week. Groups were postoperatively monitored for the development of shoulder discomfort and shoulder impingement by using physical examination and disability questionnaires. At 1 month, seven of 21 control patients reported developing shoulder pain or discomfort compared to one of 23 in the exercise group (P = 0.02). At 6 months, four of 23 control patients still reported worsening shoulder symptoms, compared to none in the exercise group (P = 0.11). In the control group, five of 19 patients developed a positive impingement test at 1 month, versus none in the exercise group (P = 0.01). Scores for the questionnaires designed to assess shoulder pain and dysfunction were worse in the control group. There were no activity-related complications in either group. CONCLUSION: Shoulder pain and disability occurs often following cardiac rhythm management device implantation. A simple exercise program aimed at strengthening the shoulder girdle is effective at preventing this complication.

Electrocardiographic findings, device therapies, and comorbidities in octogenarian implantable defibrillator recipients.

BACKGROUND: The use of implantable cardioverter-defibrillators (ICDs) in octogenarians is poorly defined. OBJECTIVE: To assess baseline electrocardiographic (ECG) findings, arrhythmia episodes, and development of severe nonarrhythmic illness or death in patients aged >or=80 years at ICD implantation, and to compare them with younger patients. METHODS: Medical records and device interrogations for 199 patients >or=70 years old who underwent ICD implantation were reviewed. Patients were divided into 3 groups based on age at the time of implant: age 70-74 (group 1; 88 patients), age 75-79 (group 2; 67 patients), and age >or=80 (group 3; 44 patients). RESULTS: ECGs: Octogenarians were more likely to have sinus bradycardia (SB) (P = 0.047) and left bundle branch block (LBBB) (P = 0.043) compared to younger patients. There was no difference among groups in the proportion of patients with atrial fibrillation or any degree of AV block. THERAPIES: There was no difference between age groups in any therapy (P = 0.78), appropriate therapy (P = 0.54), or inappropriate therapy (P = 0.21) per patient-year. There was no difference between groups in time-to-first therapy of any type (P = 0.71). NONARRHYTHMIC DEATH/MORBIDITY: There was no difference between groups in time to death or serious illness. CONCLUSION: Our study is the first to evaluate in detail the therapies received by octogenarians after ICD placement. The higher incidence of SB and LBBB might influence the number of pacing sites in octogenarian patients. Very elderly patients have similar rates of arrhythmic episodes and development of severe comorbidities as septuagenarians, and they should not be denied ICD implantation based solely on age.

Mechanical valve dysfunction after percutaneous perimitral leak closure: salvage by percutaneous occluder retrieval.

Percutaneous closure of perivalvular regurgitation may be complicated by prosthetic valve impingement and dysfunction. We describe a patient with two perimitral defects who developed severe mitral stenosis due to mitral leaflet impingement after percutaneous implantation of three amplatzer muscular ventricular septal defect occluder devices. The largest amplatzer occluder device was successfully snared with restoration of normal prosthetic valve motion.

Contemporary use of embolic protection devices in saphenous vein graft interventions: Insights from the stenting of saphenous vein grafts trial.

BACKGROUND: We sought to evaluate the contemporary use of embolic protection devices (EPDs) in saphenous vein graft (SVG) interventions. METHODS: We examined EPD use in the stenting of saphenous vein grafts (SOS) trial, in which 80 patients with 112 lesions in 88 SVGs were randomized to a bare metal stent (39 patients, 43 grafts, and 55 lesions) or paclitaxel-eluting stent (41 patients, 45 grafts, and 57 lesions). RESULTS: An EPD was used in 60 of 112 lesions (54%). A Filterwire (Boston Scientific) was used in 70% of EPD-treated lesions, Spider (ev3, Plymouth, Minnesota) in 12%, Proxis (St. Jude, Minneapolis, Minnesota) in 12%, and Guardwire (Medtronic, Santa Rosa, California) in 7%. Of the remaining 52 lesions, an EPD was not utilized in 13 lesions (25%) because the lesion was near the distal anastomosis, in 14 lesions (27%) because of an ostial location, in one lesion (2%) because of small SVG size, in two in-stent restenosis lesions (4%) because of low distal embolization risk, and in 22 lesions (42%) because of operator's preference even though use of an EPD was feasible. Procedural success was achieved in 77 patients (96%); in one patient a Filterwire was entrapped requiring emergency coronary bypass graft surgery and two patients had acute stent thrombosis. CONCLUSION: In spite of their proven efficacy, EPDs were utilized in approximately half of SVG interventions in the SOS trial. Availability of a proximal protection device could allow protection of approximately 25% of unprotected lesions, yet operator discretion appears to be the major determinant of EPD use.

Habitual cocaine use is associated with high defibrillation threshold during ICD implantation.

BACKGROUND: Habitual cocaine use can lead to dilated cardiomyopathy (DCM) and sudden cardiac death. Based on prior clinical observations, we hypothesized that prior habitual cocaine use is a strong predictor of high defibrillation threshold (DFT) during implantable cardioverter-defibrillator (ICD) implant. METHODS: We reviewed the medical records of 130 consecutive patients undergoing initial ICD implantation or revision at Parkland Hospital and the Dallas VA Hospital, Dallas, TX, from January 2002 to November 2005. Patient characteristics and DFT data were collected retrospectively. RESULTS: The study group includes 11 patients (8.46%) who were identified as having a history of prior habitual cocaine use as demonstrated by history and urine toxicology; the rest (119 patients) form the control group. Cocaine-using patients tended to be younger (48.2 +/- 10 vs 60.1 +/- 12.3 years; P = 0.0026), were less likely to have coronary disease (36.3% vs 72.2%; P = 0.032), and had less comorbidity. The average DFT was 27.9 +/- 7.8 J for all cocaine-using patients and 14.5 +/- 4.1 J for noncocaine-using patients (P = 0.00018). In the cocaine-using group, three out of 11 patients required a subcutaneous array compared to none in the control group. CONCLUSIONS: Our results suggest that patients with a history of habitual cocaine use may be at increased risk to have a high DFT during ICD implantation. This is the first study to demonstrate such association. ICD implantation in patients with this history should be planned with these findings in mind, as larger output generators or subcutaneous arrays might be required.

Embolic complications of direct current cardioversion of atrial arrhythmias: association with low intensity of anticoagulation at the time of cardioversion.

OBJECTIVES: The goal of this study was to identify the factors responsible for embolic complications of direct current (DC) cardioversion of atrial arrhythmias. BACKGROUND: Direct current cardioversion of atrial fibrillation (AF) carries a risk of thromboembolism, which is reduced, but not eliminated, by anticoagulation. The risk of embolism after conversion of atrial flutter is believed to be lower. No series to date has included enough patients receiving anticoagulants or enough patients with atrial flutter to estimate the risk in these groups. METHODS: We reviewed the case records of 1,950 patients who underwent 2,639 attempts at DC cardioversion. RESULTS: Cardioversion was performed within two days of the apparent onset of the arrhythmia in 443 episodes, 352 without subsequent prolonged anticoagulation with one embolic complication. Cardioversion was preceded by warfarin therapy for > or = 3 weeks in 1,932 instances. No embolic complication occurred in 779 attempts performed with an international normalized ratio (INR) of > or = 2.5 (95% confidence limits 0% to 0.48%). Of 756 cases in which the INR was <2.5 or was not measured before conversion, nine were complicated by thromboembolism. Embolism was significantly more common at an INR of 1.5 to 2.4 than at an INR > or = 2.5 (0.93% vs. 0%, p = 0.012). The incidence of embolism after conversion of atrial flutter or tachycardia was similar to that after cardioversion of AF (0.72% vs. 0.46%, p = NS). CONCLUSIONS: The INR should be > or = 2.5 at the time of cardioversion if the duration of AF is uncertain or >2 days. Cardioversion of atrial flutter presents similar risks and requires similar anticoagulation.

Impact of Chronic Total Occlusions and Coronary Revascularization on All-Cause Mortality and the Incidence of Ventricular Arrhythmias in Patients With Ischemic Cardiomyopathy.

Coronary chronic total occlusions (CTOs) have been associated with higher mortality in patients with ischemic cardiomyopathy and implantable cardioverter defibrillators (ICDs); yet the impact of CTO revascularization on subsequent clinical outcomes has not been studied. We evaluated the clinical characteristics and outcomes of patients with ischemic cardiomyopathy who also received an ICD for primary prevention of sudden death at the Dallas VA Medical Center from January 2002 to December 2013. On the basis of coronary angiography performed before device implantation, patients were divided into 3 groups: no CTOs, revascularized CTOs (with percutaneous coronary intervention or surgery), and unrevascularized CTOs. Primary and secondary outcomes were all-cause mortality and appropriate ICD therapy for sustained ventricular arrhythmias. A total of 307 patients (mean age 64.3 ± 8.1 years, 100% men) were included in the study. At least 1 CTO was present in 213 patients (69%) and was revascularized in 99 patients (32%). During a median follow-up of 4.1 years, 51 patients (17%) died and 98 (32%) had at least 1 episode of sustained ventricular arrhythmia. Mortality and incidence of ventricular arrhythmias were similar in the 3 study groups in both univariate and multivariate analyses. In conclusion, CTOs are commonly found in patients with ischemic cardiomyopathy. In contrast to previous studies, the presence of a CTO was not associated with higher mortality or incidence of ventricular arrhythmias. In addition, revascularization of CTOs was not associated with improved outcomes in this high-risk cohort.

Newer algorithms in bradycardia management.

Permanent cardiac pacemakers (PPM) are effective in the treatment of bradycardia in a growing number of clinical scenarios. An appreciation of the capacity of PPMs to result in negative hemodynamic and proarrhythmic effects has grown alongside clinical experience with permanent pacing. Such experience has necessitated the development of algorithms aimed at optimizing device functionality across a broad spectrum of physiologic and pathologic conditions. This review highlights recent device-based algorithms used in automated threshold testing, reduction of right ventricular pacing, prevention and treatment of pacemaker-mediated tachycardia, mode switching for atrial tachyarrhythmias, rate-modulated pacing, and advances in arrhythmia storage and remote monitoring.

Current trends in supraventricular tachycardia management.

BACKGROUND: Supraventricular tachycardia (SVT) is a general term describing a group of arrhythmias whose mechanism involves or is above the atrioventricular node. The mechanisms of most forms of SVT have been elucidated, and pharmacologic and invasive therapies have evolved simultaneously. METHODS: We provide a brief overview of the mechanisms, classifications, and electrocardiographic characteristics of different SVTs and describe current trends in noninvasive and invasive therapies. RESULTS: The term SVT encompasses a heterogeneous group of arrhythmias with different electrophysiologic characteristics. Knowledge of the mechanism of each SVT is important in determining management at the bedside and in the electrophysiology laboratory. CONCLUSION: In the acute setting, vagal maneuvers and pharmacologic therapy can be effective in arrhythmia termination. Catheter-based radiofrequency ablation has revolutionized therapy for many SVTs, and newer techniques have significantly improved ablation efficacy and reduced periprocedural complications and procedure times. Cryoablation is currently being investigated as an alternative form of energy delivery, although the long-term effectiveness of this procedure currently limits its use for many SVTs.

Prevalence and outcomes of intermediate saphenous vein graft lesions: findings from the stenting of saphenous vein grafts randomized-controlled trial.

BACKGROUND: We sought to examine the prevalence and progression rate of intermediate saphenous vein graft (SVG) lesions in the Stenting Of Saphenous vein grafts (SOS) trial. METHODS: The baseline and follow-up angiograms of 80 patients participating in the SOS trial were analyzed to determine the prevalence of intermediate (30-60% angiographic diameter stenosis) SVG lesions and their progression rate. RESULTS: At least one intermediate SVG lesion was present in 31 of 143 (22%) SVGs in 27 of 80 (34%) patients. Most intermediate lesions were present in the SOS stented SVGs (20 grafts in 19 patients). During a median follow-up of 35 months, angiographic follow-up was available for 28 grafts in 25 patients. Progression (defined as percent diameter stenosis ≥ 70% but <100% at follow-up angiography) was seen in 11 of 28 SVGs (39%) in 11 of 25 patients (44%). Progression rate at 12, 24 and 36 months was 28% and 47% and 84%, respectively. Seven of 11 patients (64%) with intermediate SVG lesion progression presented with an acute coronary syndrome and 8 (73%) underwent PCI. Four of the 28 grafts with intermediate lesions at baseline were 100% occluded at follow-up; all of those SVGs had received a stent in another location in the SVG as part of the SOS trial. CONCLUSIONS: Intermediate SVG lesions are common in patients undergoing SVG stenting, have high rates of progression and frequently present with an acute coronary syndrome. Further study of pharmacologic and mechanical treatments to prevent progression of these lesions is needed.

Continued benefit from paclitaxel-eluting compared with bare-metal stent implantation in saphenous vein graft lesions during long-term follow-up of the SOS (Stenting of Saphenous Vein Grafts) trial.

OBJECTIVES: This study sought to report the long-term outcomes after drug-eluting stent (DES) implantation in saphenous vein graft (SVG) lesions in the SOS (Stenting of Saphenous Vein Grafts) trial. BACKGROUND: The long-term outcomes after DES implantation in SVGs are poorly studied. Apart from the SOS trial, the only other randomized trial comparing DES with bare-metal stents (BMS) in SVGs reported higher mortality in the DES group at 32 months. METHODS: In the SOS trial, 80 patients with 112 lesions in 88 SVGs were randomized to a BMS or paclitaxel-eluting stent (PES) and demonstrated improved short-term angiographic and clinical outcomes with PES. Extended clinical follow-up was subsequently obtained. RESULTS: Mean age was 67 ± 9 years, and all patients were men. The indications for stenting included acute coronary syndrome in 60% and stable angina in 31% of patients. The mean SVG age was 12 ± 6 years. The baseline characteristics of the patients in the 2 study groups were similar. Procedural success was achieved in 77 patients (96%). During a median follow-up of 35 months, compared with patients randomized to BMS, those receiving PES had a lower incidence of myocardial infarction (hazard ratio [HR]: 0.32, p = 0.01), target lesion revascularization (HR: 0.20, p = 0.004), target vessel revascularization (HR: 0.41, p = 0.03), and target vessel failure (HR: 0.34, p = 0.001) as well as a trend toward less definite or probable stent thrombosis (HR: 0.15, p = 0.08). All-cause mortality (HR: 2.04, p = 0.19) and cardiac mortality (HR: 0.62, p = 0.51) did not differ between groups. CONCLUSIONS: During long-term follow-up, use of PES was associated with significantly better clinical outcomes than BMS in SVG lesions. (Stenting of Saphenous Vein Grafts Trial [SOS]; NCT00247208).

Recurrent cardiovascular events with paclitaxel-eluting versus bare-metal stents in saphenous vein graft lesions: insights from the SOS (Stenting of Saphenous Vein Grafts) trial.

UNLABELLED: The Stenting of Saphenous Vein Grafts (SOS) trial demonstrated a reduction in clinical and angiographic adverse events with paclitaxel-eluting stents (PES) compared to bare-metal stents (BMS) in saphenous vein graft (SVG) lesions, but the rate of recurrent adverse events has not been described. METHODS: We performed a post hoc, landmark analysis to evaluate the risk of event recurrence following a non-fatal initial event among the SOS trial patients (pts). RESULTS: During a median follow-up of 35 months, the 80 pts enrolled in SOS experienced a total of 78 major cardiovascular events (MACE): 51 in the BMS group and 27 in PES group. No MACE were found in 28 pts (35%) while 52 pts (65%) had at least one event. The initial event was death in 13 pts (16%). Among the 39 pts whose initial event was not fatal, 12 (31%) had one or more subsequent MACE (50% of which were definitely related to the study SVG). The mean and median number of MACE per patient was significantly higher in patients receiving BMS versus PES (1.3 ± 1.2 and 1 ± 1.26 versus 0.6 ± 0.7 and 1 ± 0.825, p = 0.005 and p = 0.008, respectively). The rate of a second MACE following an initial event was 17% in the PES group and 37% in the BMS group (p = 0.24). Ten of 12 pts with recurrent events had received a BMS (83%). CONCLUSION: Pts undergoing SVG stenting had a high rate of recurrent events after an initial non-fatal event. These events were often related to the target vessel and most occurred in pts who had received a BMS, further supporting the benefit of PES over BMS in SVG lesions.

Paclitaxel-eluting stents reduce neointimal hyperplasia compared to bare metal stents in saphenous vein grafts: intravascular ultrasonography analysis of the SOS (Stenting of Saphenous Vein Grafts) trial.

AIMS: To compare the intravascular ultrasonography (IVUS) findings between saphenous vein grafts (SVG) treated with paclitaxel-eluting stents (PES) vs. bare metal stents (BMS) in the Stenting Of Saphenous Vein Grafts (SOS) trial. METHODS AND RESULTS: Of the 80 SOS trial patients, 38 had both baseline and follow-up IVUS examination and were included in this substudy: 17 patients received 28 BMS in 26 lesions and 21 patients received 30 PES in 28 lesions. Quantitative IVUS analysis was performed to determine the volume of in-stent neointimal hyperplasia (NIH) - defined as the difference between stent volume and lumen volume in the stented segments. Baseline characteristics were similar between patients who did and did not undergo baseline and follow-up IVUS. Patients receiving BMS and PES had similar stent and lumen volumes immediately after stenting. At 12-month follow-up, compared to BMS, PES-treated lesions had significantly less NIH volume (3.4 vs. 21.9 mm³, p<0.001) and neointima hyperplasia progression (1.6 vs. 17.1 mm³, p<0.001). No significant differences were seen in the 5 mm segment proximal and distal to the stent. CONCLUSIONS: Compared to BMS, use of PES in SVG lesions is associated with significantly lower NIH formation, which may help explain the improved clinical outcomes with PES in these lesions.