Implantation of left ventricular leads using a telescopic catheter system

BACKGROUND: Implantation procedures for cardiac resynchronization therapy (CRT) remain challenging with regard to coronary sinus (CS) cannulation and left ventricular (LV) lead positioning. Technologic advances in catheter design may facilitate CS cannulation and LV lead placement. AIMS: To evaluate two different telescoping dual-catheter systems, RAPIDO Guiding Catheter System (Group R) and RAPIDO ADVANCE Guiding Catheter System (Group A) (Guidant Inc., St. Paul, MN, USA), during implantation of a CRT device. METHODS: Seventy-four consecutive patients randomly received a CRT device using the R or A system. RESULTS: An LV lead was successfully implanted in 74 patients (100%). (1) Median times for CS cannulation in groups R and A were 0.3 minutes (range from 0.05 to 14 minutes) and 0.5 minutes (range from 0.05 to 9 minutes), respectively (P = NS). (2) Median times for LV lead placement were 8 minutes (range from 0.8 to 100 minutes) and 3.5 minutes (range from 0.25 to 30 minutes), respectively, for groups R and A (P = 0.032). (3) Median total fluoroscopy times were 12.33 minutes (range from 5 to 70 minutes) and 14.33 minutes (range from 6 to 53 minutes) for groups R and A, respectively (P = NS). (4) Median procedural times for CRT implantation were 80 minutes (range from 40 to 200 minutes) and 75 minutes (range from 45 to 180 minutes) (P = NS) in groups R and A, respectively. There were no major complications. CONCLUSION: CS cannulation and LV lead placement with a telescopic dual-catheter system is a safe and feasible approach that may reduce fluoroscopy and overall CRT implantation times. Our observations suggest that the RAPIDO ADVANCE System is faster than the RAPIDO System in terms of median time for LV lead positioning.     

Greater three-dimensional ventricular lead tip separation is associated with improved outcome after cardiac resynchronization therapy

Background: Effective cardiac resynchronization therapy (CRT) is more likely with widely separated left ventricular (LV) and right ventricular (RV) pacing leads tips. We hypothesized that lead separation is an important factor in determining the clinical response to CRT. Methods: A retrospective study of 86 consecutive patients age 71 ± 10 years, male (74%), coronary disease (71%), atrial fibrillation (23%), LV ejection fraction (22 ± 9%), QRS duration (160 ± 27 ms), New York Heart Association (NYHA) class III (81%), NYHA class IV (19%) undergoing CRT from January 2006 to September 2008. The median follow‐up was 12 months and clinical response to CRT was defined as reduction of NYHA class by one or more. The three‐dimensional separation between RV and LV pacing lead tips was calculated using measurements obtained from orthogonal posteroanterior and lateral chest radiographs performed the day after implantation. Results: Fifty‐nine patients (69%) responded to CRT. There was a statistically significant association between increased three‐dimensional lead separation and clinical response to CRT (P= 0.005). Stronger association was obtained when lead separation was corrected for cardiac size (P= 0.001). A significantly higher response rate of 88% was achieved in patients with QRS duration of 160 ms or more, and lead separation of 100 mm or more compared with 60% when lead separation was less than 100 mm and QRS duration remained the same (P = 0.027). Conclusions: Greater three‐dimensional separation of LV‐to‐RV leads is associated with improved response to CRT. A prospective multicenter trial is needed to assess lead separation as a predictor for response. (PACE 2010; 33:1490–1496)     

Fluoroscopic left ventricular lead position and the long-term clinical outcome of cardiac resynchronization therapy

Background: To determine the effects of left ventricular (LV) lead tip position on the long‐term outcome of cardiac resynchronization therapy (CRT). Setting: Cardiac device therapy center. Patients: Five hundred and fifty‐six patients (age 70.4 ± 10.7 years [mean ± standard deviation]). Interventions: CRT‐pacing or CRT‐defibrillation device implantation. Main outcome measures: Cardiovascular mortality and events over a maximum follow‐up period of 9.1 years. Results: Hazard ratios (HRs [95% 785]797) for cardiovascular mortality, adjusted for age, gender, QRS duration, heart failure etiology, New York Heart Association class, and presence of diabetes and atrial fibrillation, were derived for LV lead tip positions in terms of veins, circumferential, and longitudinal positions with respect to the LV chamber. For vein position, these were 1.07 (0.74–1.56) for anterolateral vein position and 1.24 (0.79–1.95) for the middle cardiac vein, compared with a posterolateral vein. For circumferential lead tip position, HRs were 1.56 (0.73–3.34) for anterolateral and 1.57 (0.76–3.25) for lateral, compared with posterior positions. For longitudinal lead tip positions, HRs were 1.02 (0.72–1.46) for basal and 1.21 (0.68–2.17) for apical, compared with mid‐ventricular positions. The risk of meeting the composite endpoints of cardiovascular death or hospitalizations for heart failure and death from any cause or hospitalizations for major adverse cardiovascular events was similar among the various LV lead tip positions. Conclusions: The position of the LV lead over the LV free wall, assessed by fluoroscopy, has no influence over the long‐term outcome of CRT. (PACE 2011; 34:1–13)     

X-ray and magnetic resonance imaging fusion for cardiac resynchronization therapy

Cardiac Resynchronization Therapy (CRT) can effectively treat left ventricle (LV) driven Heart Failure (HF). However, 30% of the CRT recipients do not experience symptomatic benefit. Recent studies show that the CRT response rate can reach 95% when the LV pacing lead is placed at an optimal site at a region of maximal LV dyssynchrony and away from myocardial scars. Cardiac Magnetic Resonance (CMR) can identify the optimal site in three dimensions (3D). 3D CMR data can be registered to clinical standard x-ray fluoroscopy to achieve an optimal pacing of the LV. We have developed a 3D CMR to 2D x-ray image registration method for CRT procedures. We have employed the LV pacing lead on x-ray images and coronary sinus on MR data as landmarks. The registration method makes use of a guidewire simulation algorithm, edge based image registration technique and x-ray C-arm tracking to register the coronary sinus and pacing lead landmarks.     

Effect of percutaneous interventions within the coronary sinus on the success rate of the implantations of resynchronization pacemakers

BACKGROUND: Cardiac resynchronization therapy (CRT) becomes a "gold standard" in therapy of selected patients with advanced heart failure. We set out to evaluate the feasibility and safety of percutaneous interventions within coronary sinus (CS) and their effect on the success rate of left ventricular (LV) lead implantation during CRT. METHODS: The study analyzed eight consecutive patients with the indications for CRT, who needed additional procedures within CS to overcome technical problems during left ventricular (LV) electrode implantation. The analyzed group consisted of three subgroups: patients in whom percutaneous balloon angioplasty within CS was needed (n = 4); patients with acute instability of the lead, requiring stenting of the vein to fix the electrode (n = 2); and patients with the stenting of CS due to late dislocation of the lead (n = 2). Success rate, procedure duration, fluoroscopy, complications, and electrical parameters of leads were analyzed. RESULTS: Success rate of the procedures was 87.5%; additional interventions increased overall efficacy of CRT implantation at our center from 88% to 98% (P < 0.05). Procedure duration (155.0 minute) and fluoroscopy time (42.5 minute) remained acceptable for the patient and operator; however, both were higher than in the procedures performed routinely in our hospital. Electrical properties of the LV leads were stable and within normal ranges during the observation period. We noted two local dissections of CS during the procedure, which remained clinically silent. CONCLUSION: Percutaneous interventions within CS seem to be feasible and safe treatment options, which can improve the short- and long-term success rates of CRT.     

Cardiac resynchronization therapy guided by late gadolinium-enhancement cardiovascular magnetic resonance

Background

Myocardial scarring at the LV pacing site leads to incomplete resynchronization and a suboptimal symptomatic response to CRT. We sought to determine whether the use of late gadolinium cardiovascular magnetic resonance (LGE-CMR) to guide left ventricular (LV) lead deployment influences the long-term outcome of cardiac resynchronization therapy (CRT).

Methods

559 patients with heart failure (age 70.4 ± 10.7 yrs [mean ± SD]) due to ischemic or non-ischemic cardiomyopathy underwent CRT. Implantations were either guided (+CMR) or not guided (-CMR) by LGE-CMR prior to implantation. Fluoroscopy and LGE-CMR were used to localize the LV lead tip and and myocardial scarring retrospectively. Clinical events were assessed in three groups: +CMR and pacing scar (+CMR+S); CMR and not pacing scar (+CMR-S), and; LV pacing not guided by CMR (-CMR).

Results

Over a maximum follow-up of 9.1 yrs, +CMR+S had the highest risk of cardiovascular death (HR: 6.34), cardiovascular death or hospitalizations for heart failure (HR: 5.57) and death from any cause or hospitalizations for major adverse cardiovascular events (HR: 4.74) (all P < 0.0001), compared with +CMR-S. An intermediate risk of meeting these endpoints was observed for -CMR, with HRs of 1.51 (P = 0.0726), 1.61 (P = 0.0169) and 1.87 (p = 0.0005), respectively. The +CMR+S group had the highest risk of death from pump failure (HR: 5.40, p < 0.0001) and sudden cardiac death (HR: 4.40, p = 0.0218), in relation to the +CMR-S group.

Conclusions

Compared with a conventional implantation approach, the use of LGE-CMR to guide LV lead deployment away from scarred myocardium results in a better clinical outcome after CRT. Pacing scarred myocardium was associated with the worst outcome, in terms of both pump failure and sudden cardiac death.     

Use of preshaped sheath to plan and facilitate cannulation of the coronary sinus for the implantation of cardiac resynchronization therapy devices: preshaped sheath for implantation of biventricular devices

OBJECTIVES: The aim of the study is to describe a new technique for facilitating the implantation of cardiac resynchronization therapy (CRT) devices. BACKGROUND: CRT, by simultaneous pacing of the right and left ventricles has proven to be a useful treatment for patients with advanced heart failure and left ventricular (LV) systolic dysfunction, who have concomitant LV dyssynchrony. One of the greatest challenges to the wide applications of this therapy has been the technical difficulty encountered with implantation of the left ventricular lead. This is mainly due to the varied anatomy of the coronary venous system, which is further complicated by distortion of the anatomy in patients with advanced heart failure. METHODS: Details of the coronary venous anatomy are initially assessed by cannulating the coronary sinus (CS) using a specialized long preshaped sheath introduced from the femoral approach. Occlusive venography is performed in three views, and then the guide wire or the deflated balloon catheter is left in the CS for guidance. The most suitable equipment for the anatomy is chosen. Then, the operative site is prepped and the CS is approached from above. RESULTS: From November 2003 until December 2004, we have used this approach on all patients presenting for CRT device implantation at Prince Sultan Cardiac Center (n = 25). The CS was cannulated using the preshaped catheter in less than 5 minutes in all cases. After delineation of the anatomy, successful CRT implantation was achieved in all patients. Mean procedure time for the implantation was 110 +/- 18 minutes. Uncomplicated minor CS dissection related to the use of the preshaped sheath was observed in 1 patient without consequences. CONCLUSIONS: The use of preshaped sheath from the femoral approach facilitates planning the successful and safe implantation of CRT systems.     

Two-year performance of a preshaped lead for left ventricular stimulation

Important goals, when implanting a cardiac resynchronization therapy (CRT) system, are to reach a stable LV lead position in a suitable coronary sinus (CS) tributary associated with a low capture threshold and no extracardiac stimulation. The aim of this study was to assess the 2-year performance of a new preshaped lead designed for LV stimulation. The study enrolled 102 patients with heart failure and bundle branch block who underwent implantation of a CRT system, including a sheath-guided, unipolar, S-shaped LV lead placed in a CS tributary. At each follow-up the electrical parameters and CRT system related adverse events were recorded. Eight patients who underwent LV stimulation alone, versus 88 patients who received biventricular CRT systems, were analyzed separately. Access to the CS was reached in 98 patients, and the lead was permanently implanted in 96 (94%) patients. The overall procedural time was 98 +/- 28 minutes. During follow-up, three patients underwent reinterventions for phrenic nerve stimulation (n = 2) and hematoma (n = 1). The capture threshold at implantation was 1.4 +/- 0.9 V with LV versus 1.7 +/- 0.5 V with biventricular stimulation, and after a transient increase, remained between 1.6 and 1.9 V in both configurations. The device measured impedance was significantly higher with LV than with biventricular stimulation at the time of CRT system implantation (698 +/- 296 Omega vs 380 +/- 67 Omega, P < 0.05) and during follow-up. The initial R wave amplitude was 14.3 +/- 5.9 mV in LV versus 8.9 +/- 3.2 V in the biventricular configuration (NS) and 13.8 +/- 7 mV in LV versus 12.8 +/- 4.8 mV in the biventricular configuration at 24 months (NS). Implantation of the S-shaped LV lead for CRT was safe, expeditious, and associated with a high success rate and reliable long-term performance.     

Coronary Sinus Aneurysm and Left Ventricular‐Coronary Sinus Fistula. Implantation of CRT Device

We describe a 72‐year‐old man referred for implantation of a cardiac resynchronization therapy device who had previously undergone repeated operations to replace the mitral valve. Retrograde venography of the coronary sinus (CS) to implant the left ventricular (LV) pacing lead revealed aneurysmal dilatation of the CS with LV‐CS fistula that hindered—but did not prevent—complete implantation of the system. (PACE 2013; 36:e38–e40)     

Transseptal left ventricular endocardial pacing reduces dispersion of ventricular repolarization

Background: Cardiac resynchronization therapy (CRT) may be proarrhythmic in some patients. This may be due to the effect of left ventricular (LV) epicardial pacing on ventricular repolarization. The purpose of this study was to evaluate the effect of endocardial versus epicardial LV biventricular pacing on surface electrocardiogram (ECG) parameters that are known markers of arrhythmogenic repolarization. Methods: ECG markers of repolarization (QT dispersion, QTD; T peak to end, T_peak‐end; T_peak‐end dispersion, T_peak‐endD; QTc) were retrospectively measured before and after CRT in seven patients with transseptal LV endocardial leads (TS group), 28 matched patients with coronary sinus (CS) LV leads (CS group), and eight patients with surgical LV epicardial leads (SUR group). All ECGs were scanned and analyzed using digital callipers. Results: Compared to the CS group, the TS group CRT was associated with a significant postpacing reduction in QTD (?45.2 ± 35.6 vs ?4.3 ± 43.6 ms, P = 0.03) and T_peak‐end (?24.2 ± 22.1 vs 3.4 ± 26.7 ms, P = 0.02). There was a nonsignificant post‐CRT reduction in both T_peak‐endD (?11.3 ± 31.0 vs 2.4 ± 28.9 ms, P = 0.27) and QTc (?50.0 ± 46.4 vs 4.4 ± 70.2 ms, P = 0.06) in the TS versus the CS group. In contrast, there were no differences between the SUR and CS groups in terms of the effect of CRT on these repolarization parameters. Conclusions: CRT with (atrial transseptal) endocardial LV lead placement is associated with repolarization characteristics that are considered to be less arrhythmogenic than those generated by CS (epicardial) LV lead placement. Further work is needed to determine whether these changes translate to a reduction in proarrhythmia. (PACE 2011; 34:1258–1266)     

Acute hemodynamic effects of right and left ventricular lead positions during the implantation of cardiac resynchronization therapy defibrillators

Background: To evaluate the acute hemodynamic effects of different right (RV) and left ventricular (LV) pacing sites in patients undergoing the implantation of a cardiac resynchronization therapy defibrillator (CRT‐D). Methods: Stroke volume index (SVI), assessed via pulse contour analysis, and dp/dt max, obtained in the abdominal aorta, were analyzed in 21 patients with New York Heart Association class III heart failure and left bundle branch block (mean ejection fraction of 24 ± 6%), scheduled for CRT‐D implantation under general anesthesia. We compared the hemodynamic effects of RV apical (A), RV septal (B), and biventricular pacing using the worst (lowest SVI; C) and best (highest SVI; D) coronary sinus lead positions. Results: Mean arterial pressure, SVI, and dp/dt max did not differ significantly between RV apical and septal pacing. Dp/dt max and SVI increased significantly during biventricular pacing (dp/dt max: B, 588 ± 160 mmHg/s; C, 651 ± 218 mmHg/s, P = 0.03 vs B; D, 690 ± 220 mmHg/s, P = 0.02 vs C; SVI: B, 33.6 ± 5.5 mL/m², C, 34.8 ± 6.1 mL/m², P = 0.08 vs B, D 36.0 ± 6.0 mL/m², P < 0.001 vs C). The best hemodynamic response was associated with lateral or inferior lead positions in 15 patients. Other LV lead positions were most effective in six patients. Conclusions: The optimal LV lead position varies significantly among patients and should be individually determined during CRT‐D implantation. The impact of the RV stimulation site in patients with intraventricular conduction delay, undergoing CRT‐D implantation, has to be investigated in further studies. (PACE 2011; 34:1537–1543)     

Female gender is associated with a better outcome after cardiac resynchronization therapy

Background: Some studies have suggested that women respond differently to cardiac resynchronization therapy (CRT). We sought to determine whether female gender influences long‐term clinical outcome, symptomatic response as well as echocardiographic response after CRT. Methods and Results: A total of 550 patients (age 70.4 ± 10.7 yrs [mean ± standard deviation]) were followed up for a maximum of 9.1 years (median: 36.2 months) after CRT‐pacing (CRT‐P) or CRT‐defibrillation (CRT‐D) device implantation. Outcome measure included mortality as well as unplanned hospitalizations for heart failure or major adverse cardiovascular events (MACE). Female gender predicted survival from cardiovascular death (hazard ratio [HR]: 0.52, P = 0.0051), death from any cause (HR: 0.52, P = 0.0022), the composite endpoints of cardiovascular death /heart failure hospitalizations (HR: 0.56, P = 0.0036) and death from any cause/hospitalizations for MACE (HR: 0.67, P = 0.0214). Female gender predicted death from pump failure (HR: 0.55, P = 0.0330) but not sudden cardiac death. Amongst the 322 patients with follow‐up echocardiography, left ventricular (LV) reverse remodelling (≥15% reduction in LV end‐systolic volume) was more pronounced in women (62% vs 44%, P = 0.0051). In multivariable Cox proportional hazards analyses, the association between female gender and cardiovascular survival was independent of age, LV ejection fraction, atrial rhythm, QRS duration, CRT device type, New York Heart Association (NYHA) class, and LV reverse remodelling (adjusted HR: 0.48, P = 0.0086). At one year, the symptomatic response rate (improvement by ≥1 NYHA classes or ≥25% increase in walking distance) was 78% for both women and men. Conclusions: Female gender is independently associated with a lower mortality and morbidity after CRT. (PACE 2011; 82–88)     

Site‐Specific Differences in Latency Intervals during Biventricular Pacing: Impact on Paced QRS Morphology and Echo‐Optimized V‐V Interval

Objective: To investigate differences in latency intervals during right ventricular (RV) pacing and left ventricular (LV) pacing from the (postero‐)lateral cardiac vein in cardiac resynchronization therapy (CRT) patients and their relationship to echo‐optimized interventricular (V‐V) intervals and paced QRS morphology. Methods: We recorded digital 12‐lead electrocardiograms in 40 CRT patients during RV, LV, and biventricular pacing at three output settings. Stimulus‐to‐earliest QRS deflection (latency) intervals were measured in all leads. Echocardiographic atrioventricular (AV) and V‐V optimization was performed using aortic velocity time integrals. Results: Latency intervals were longer during LV (34 ± 17, 29 ± 15, 28 ± 15 ms) versus RV apical pacing (17 ± 8, 15 ± 8, 13 ± 7 ms) for threshold, threshold ×3, and maximal output, respectively (P < 0.001), and shortened with increased stimulus strength (P < 0.05). The echo‐optimized V‐V interval was 58 ± 31 ms in five of 40 (12%) patients with LV latency ≥ 40 ms compared to 29 ± 20 ms in 35 patients with LV latency < 40 ms (P < 0.01). During simultaneous biventricular pacing, four of five (80%) patients with LV latency ≥ 40 ms exhibited a left bundle branch block (LBBB) pattern in lead V₁ compared to three of 35 (9%) patients with LV latency < 40 ms (P < 0.01). After optimization, all five patients with LV latency ≥ 40 ms registered a dominant R wave in lead V₁. Conclusions: LV pacing from the lateral cardiac vein is associated with longer latency intervals than endocardial RV pacing. LV latency causes delayed LV activation and requires V‐V interval adjustment to improve hemodynamic response to CRT. Patients with LV latency ≥ 40 ms most often display an LBBB pattern in lead V₁ during simultaneous biventricular pacing, but a right bundle branch block after V‐V interval optimization. (PACE 2010; 1382–1391)     

Transseptal Left Ventricular Lead Placement Using Snare Technique

Background: Coronary sinus (CS) lead placement for cardiac resynchronization therapy has a failure rate of ～5–10%. Here we describe a way of implanting an endocardial left ventricular (LV) lead via a transseptal puncture (TSP), using a GooseNeck snare and active fixation lead. Methods: Three male patients (67–83 years) with failed or extracted epicardial LV leads implanted via the CS had an endocardial LV lead implanted. TSP was performed via a femoral vein. The active fixation pacing lead was advanced to the right atrium from a subclavian vein. A GooseNeck snare was passed via the TSP sheath and used to grasp the tip of the pacing lead. The sheath, GooseNeck snare, and pacing lead tip were then passed to the left atrium by sliding the system up the TSP guidewire and across the interatrial septum before deflecting the lead to permit implantation in the left ventricle. Results: Successful implantation was performed in all patients with an LV implant time of 25–55 minutes. Conclusion: The use of a GooseNeck snare via a deflectable transseptal sheath represents a reliable alternative method for endocardial LV lead placement in patients with failed CS LV lead implantation. (PACE 2012; 35:1248–1252)     

Magnetic Resonance Imaging is Superior to Cardiac Scintigraphy to Identify Nonresponders to Cardiac Resynchronization Therapy

Background: Left ventricular (LV) postero-lateral scar and total scar burden are factors responsible for a poor response to cardiac resynchronization therapy (CRT). Contrast-enhanced magnetic resonance imaging (CMR) and ^99mTc-2-methoxy isobutyl isonitrile single photon emission computed tomography (SPECT) perfusion imaging are widely used to detect myocardial scar tissue; however, their ability to detect regional scars and predict a positive response to CRT has not been fully evaluated.
Methods: CMR and SPECT were performed in 17 patients with dilated cardiomyopathy (DCM) and seven patients with ischemic cardiomyopathy (ICM) before CRT. All images were scored, using a 17-segment model. To analyze the LV scar regions by CMR, we assessed the transmural delayed enhancement extent as the transmural score in each segment (0 = no scar, 4 = transmural scar). Similarly, a perfusion defect score was assigned to each segment by SPECT (0 = normal uptake, 4 = defect).
Results: By both SPECT and CMR imaging, the total scar score was significantly higher in the ICM than in the DCM group. An LV postero-lateral wall scar region was detected using both imaging modes. By SPECT imaging, the percentage of regional scar score in the LV inferior wall was significantly higher in the DCM than in the ICM group.
Conclusions: By SPECT imaging in the DCM group, severe perfusion defects, due to attenuation artifacts, were frequently observed in the LV inferior wall, resulting in the overestimation of scar tissue. CMR identified nonresponders to CRT more reliably than SPECT in patients with DCM.     

Early patient experience with an electro-anatomic navigation system dedicated to device lead implantation: feasibility and safety

Introduction: Fluoroscopy‐guided pacing lead placement has well‐recognized limitations and risks. We studied the safety and feasibility of using a novel electromagnetic navigation system specifically designed to guide pacemaker and implantable cardioverter defibrillator lead placement. Methods: Twenty‐four patients (mean age of 54 ± 34 years) underwent the study protocol; 16 before electrophysiology study and eight before device implantation. The navigational deflectable sheath assembly was introduced via the subclavian vein and advanced to seven prespecified targets within the right heart chambers. The time taken to reach each target site was measured. Results: All seven prespecified targets were successfully reached by 21 of 24 patients (88%). The total time required to complete the study protocol ranged from 3.21 to 15.25 minutes (average 8.9 minutes), with an associated mean fluoroscopy time of 50 ± 36 seconds. In three of the 24 patients, this navigation system was successfully used to guide right ventricular pacing lead placement. The average total procedure time for these devices was 97.8 minutes (excluding the study protocol), with an average associated fluoroscopy time of 6.93 minutes. These procedures were well tolerated and no periprocedural complications were noted. Conclusions: This study suggests that this novel electro‐anatomic navigation system is a viable and safe alternative to traditional fluoroscopy‐guided lead implantation. Further studies are required to determine the absolute reduction in radiation exposure and increased efficiency relative to current standard fluoroscopic techniques. PACE 2012; 35:385–391)     

A New Endocardial "Over-the-Wire" or Stylet-Driven Left Ventricular Lead:

Transvenous left ventricular (LV) leads are primarily inserted "over-the-wire" (OTW). However, a stylet-driven (SD) approach may be a helpful alternative. A new polyurethane-coated, unipolar LV lead can be placed either by a stylet or a guide wire, which can be inserted into the lead body from both ends. The multicenter OVID study evaluates the clinical performance of this new steroid- and nonsteroid eluting lead. The primary endpoint is the LV lead implant success rate after identification of the coronary sinus (CS). Secondary endpoints include complication rate, short- and long-term lead characteristics, overall procedure and LV lead placement duration, total fluoroscopy time, and lead handling characteristics ratings. To date, 96 patients with heart failure (68 ± 9 years old, 76% men) are enrolled. The CS was identified in 95 patients and, in 85 (88.5%), the LV lead was successfully implanted. The final lead positioning was lateral in 41%, posterolateral in 35%, anterolateral in 18%, and great cardiac vein in 6% of patients. In 70%, the 85 successful implantations, both stylet-driven and guide-wire techniques were used, a stylet only was used in 22%, and a guide wire only in 8%. Mean overall duration of 85 successful procedures was 112 ± 40 minutes, total fluoroscopy time 28 ± 15 minutes, and the duration of LV lead placement was 35 ± 29 minutes. During a 3-month follow-up, the loss of LV capture occurred in three and phrenic nerve stimulation in six patients. The mean long-term pacing threshold is 0.8 V/0.5 ms and pacing impedance is 550 Ω. The OVID data suggest that these new leads are safe and effective. The choice of both OTW and SD techniques during lead implantation offers greater procedural flexibility.     

Effect of transvenous cardiac resynchronization therapy device implantation on cardiac troponin I release

BACKGROUND: Pacemaker and implantable cardioverter defibrillator (ICD) implantation increases cardiac troponin I (cTnI) levels which indicates myocardial injury. During implantation of a cardiac resynchronization therapy (CRT) device, balloon inflation for coronary sinus (CS) venogram, cannulation of CS side branch, and electrode advancement may interfere with CS drainage and, hence, may decrease the washout of toxic metabolites from the heart. Thus, CRT implantation may further increase cTnI levels. In this study, we investigated the effects of CRT implantation on cTnI release. METHODS: We included 10 patients (mean age = 57 +/- 15 years) in whom a successful transvenous CRT system was implanted (CRT group). Twenty patients (mean age = 65 +/- 10 years) who underwent a transvenous pacemaker or ICD implantation were included as the control group. Blood samples for cTnI were drawn at baseline and at six, 12, 18, and 24 hours thereafter. RESULTS: Baseline median cTnI levels were similar in CRT and control groups (0.03 ng/mL vs 0.02 ng/mL, respectively; P = 0.1). Postoperative cTnI levels during 24 hours were significantly higher in the CRT group (P < 0.05) by two-way repeated measures of analysis of variance. Post hoc analysis revealed that cTnI levels were higher at the 6th, 12th, 18th, and 24th hours compared to baseline levels (P < 0.001, P < 0.001, P < 0.01, and P < 0.01, respectively). There was a significant difference in the area under the curves (AUCs) of cTnI measurements (1.79 hr.ng/mL in the CRT group and 0.78 hr.ng/mL in the control group, P < 0.05). CONCLUSION: Postoperative cTnI levels were higher after CRT implantation than simple pacemaker/ICD implantation. This may be due to CS manipulation during CRT implantation.     

Response to Cardiac Resynchronization Therapy in Patients with Heart Failure and Renal Insufficiency

Background: Renal insufficiency (RI) adversely impacts prognosis in heart failure (HF) patients, partly because renal and cardiac dysfunction are intertwined, yet few cardiac resynchronization therapy (CRT) studies have examined patients with moderate‐to‐severe RI. Methods: We analyzed 787 CRT‐defibrillator (CRT‐D) recipients with a glomerular filtration rate (GFR) measured prior to implant. Patients were grouped by GFR (in mL/min/1.73 m²): ≥60 (n = 376), 30–59 (n = 347), and <30 (n = 64). Overall survival, changes in left ventricular (LV) ejection fraction and LV end‐systolic diameter, and GFR change at 3–6 months were compared among CRT‐D groups and with a control cohort (n = 88), also stratified by GFR, in whom LV lead implant was unsuccessful and a standard defibrillator (SD) was placed. All patients met clinical criteria for CRT‐D. Results: Among CRT‐D recipients, overall survival improved incrementally with higher baseline GFR (for each 10 mL/min/1.73 m² increase, corrected hazard ratio [HR] 1.21, 95% confidence interval [CI] 1.13–1.30, P < 0.0001). Survival among SD and CRT‐D patients within GFR < 30 and GFR ≥ 60 groups was similar, whereas CRT‐D recipients with GFR 30–59 had significantly better survival compared to SD counterparts (HR 2.23, 95% CI 1.34–3.70; P = 0.002). This survival benefit was associated with improved renal and cardiac function. CRT recipients with GFR ≥ 60 derived significant echocardiographic benefit but experienced a GFR decline, whereas those with GFR < 30 had no echocardiographic benefit but did improve GFR. Conclusions: CRT may provide the largest survival benefit in HF patients with moderate RI, perhaps by improving GFR and LV function. Severe baseline RI predicts poor survival and limited echocardiographic improvement despite a modest GFR increase, such that CRT may not benefit those with GFR < 30 mL/min/1.73 m². CRT recipients with normal renal function derive echocardiographic benefit but no overall survival advantage. (PACE 2010; 850–859)     

Long-term outcome of leads and patients following robotic epicardial left ventricular lead placement for cardiac resynchronization therapy

Introduction: In cardiac resynchronization therapy (CRT), positive clinical response and reverse remodeling have been reported using robotically assisted left ventricular (LV) epicardial lead placement. However, the long‐term performance of epicardial leads and long‐term outcome of patients who undergo CRT via robotic assistance are unknown. In addition, since the LV lead placement is more invasive than a transvenous procedure, it is important to identify patients at higher risk of complications. Methods: We evaluated 78 consecutive patients (70 ± 11 years, 50 male) who underwent robotic epicardial LV lead placement. The short‐ (<12 months) and long‐term (≥12 months) lead performance was determined through device interrogations. Mortality data were determined by contact with the patient's family and referring physicians and confirmed using the Social Security Death Index. Results: All patients had successful lead placement and were discharged in stable condition. When compared to the time of implantation, there was a significant increase in pacing threshold (1.0 ± 0.5 vs 2.14 ± 1.2; P < 0.001) and decrease in lead impedance (1010 ± 240 Ω vs 491 ± 209 Ω; P < 0.001) at short‐term follow‐up. The pacing threshold (2.3 ± 1.2 vs 2.14 ± 1.2; P = 0.30) and lead impedance (451 ± 157 Ω vs 491 ± 209 Ω; P = 0.10) remained stable during long‐term follow‐up when compared to short‐term values. At a follow‐up of 44 ± 21 months, there were 20 deaths (26%). These patients were older (77 ± 7 vs 67 ± 11 years; P = 0.001) and had a lower ejection fraction (EF) (13 ± 7% vs 18 ± 9%; P = 0.02) than surviving patients. Conclusion: Robotically implanted epicardial LV leads for CRT perform well over short‐ and long‐term follow‐up. Older patients with a very low EF are at higher risk of death. The risks and benefits of this procedure should be carefully considered in these patients. (PACE 2011; 34:235–240)