Prevalence of asymptomatic upper extremity venous obstruction in 302 patients undergoing first implantation of cardioverter defibrillator

Background: Little is known about the prevalence of upper extremity vein obstruction or anomalies in patients before first implantation of implantable cardioverter defibrillator (ICD). It remains unclear in which patients contrast venography is warranted before implantation procedure. Methods: Results of clinical data and contrast venography of 302 consecutive patients scheduled for first ICD implantation were analyzed. Results: Prevalence of upper vein obstruction was 6.6% (20/302 patients) in a typical patient population undergoing first ICD implantation. Age, left ventricular ejection fraction, underlying heart disease, prior open‐heart surgery, or cardiopulmonary resuscitation were not predictors of obstruction. Patients with previous cardiac pacemaker implantation had a higher rate of obstruction, though this was not statistically significant (20% vs 15.7%, P = 0.54). Persistent left vena cava was found in 0.7%. Conclusion: There is no clinical parameter sufficient enough to predict upper extremity venous obstruction. Contrast venography may be considered in patients with previous pacemaker placement but should not be a routine diagnostic tool in unselected patients prior to first ICD‐implantation procedure. (PACE 2011; 684–689)     

The innominate vein as alternative venous access for complicated implantable cardioverter defibrillator revisions

BACKGROUND: Venous complications of implantable cardioverter defibrillator (ICD) systems may cause significant problems when the need for system revision or upgrades arises. Such revisions require venous access close to the site of the previous ICD implantation. The internal and external jugular vein have disadvantages due to a long subcutaneous course crossing the clavicle and problems with lead extraction if infection occurs. METHODS: In seven patients with ICD revisions due to lead dysfunction (n = 4) and upgrade to a biventricular device (n = 2) and status after system removal due to infection with new device implantation (n = 1) conventional venous access could not be obtained. Intraoperative contrast venography demonstrated an occluded left subclavian and/or left innominate vein in all patients. In all patients, we gained venous access through puncture of the right innominate vein and tunneled the new lead subcutaneously to the ICD pocket on the left. RESULTS: No intraoperative complications were observed. All patients are followed in our ICD clinic. Mean follow-up is 16 +/- 4 months now. So far, no clinical or lead complications with this access have been observed. CONCLUSIONS: We have demonstrated that ICD lead placement through puncture of the right innominate vein is feasible. We propose the innominate vein as an alternative route for establishing venous access in patients requiring ICD revisions or upgrades who suffer from venous obstruction. ICD implanting physicians should acquaint themselves with the technique of right innominate vein puncture to use this vein as a bail-out strategy in patients with complicated venous access.     

Supraclavicular Vein Approach for Upgrading an Implantable Cardioverter Defibrillator to a Biventricular Device

Total occlusion of the left subclavian vein was found in a 52‐year‐old patient, 5 years after implantation of an implantable cardioverter defibrillator (ICD). During replacement, the ICD was upgraded to a biventricular device for worsening of the patient's congestive heart failure to New York Heart Association class III. Insertion of the left ventricular lead in the ipsilateral vein system was successfully achieved by using the supraclavicular approach, enabling puncturing of the left subclavian vein medially to the obstruction. (PACE 2010; 634–636)     

Double Target Method (Double Marker-Guided Extrathoracic Introducer Insertion)

Incidence of damage to pacemaker and implantable cardioverter defibrillator leads is an emerging problem that should be prevented. The extrathoracic venipuncture approach has been suggested as a technique for venous access to avoid the problem. This report describes the method of double marker-guided venipuncture of extrathoracic subclavian and/or axillary vein. This approach achieves definite, safe, and speedy extrathoracic venipuncture and may be especially suitable for multiple lead placement for cardiac resynchronization therapy. (PACE 2004; 27[Pt. I]:818–820)     

Biventricular defibrillator patients have higher complication rates after revision of recalled leads

Background: Since the 2009 revised advisory statement regarding Sprint Fidelis® Defibrillator Lead failure rates (Medtronic Inc., Minneapolis, MN, USA), there has been a significant increase in revision of these leads. We sought to establish the frequency of major procedural complications and determine what patient characteristics were associated with these outcomes. Methods: We retrospectively reviewed the charts of 621 patients with Fidelis® leads being followed in the University of Pittsburgh Medical Center through January 1, 2010. The population was then examined for rates of lead malfunction, revision, and complication. Results: The average time from implantation of Fidelis® lead to endpoint was 32 ± 16 months. Overall lead survival rates were 89% at 41 months and were lower in biventricular implantable cardioverter defibrillator (BiVICD) as compared to standard implantable cardioverter defibrillator patients (log rank P = 0.053). Prophylactic revisions increased dramatically during 2009 (9.4% vs 1.4%, P < 0.001). Among the 131 patients who underwent revision during the entire time of follow‐up, 11 patients had postoperative complications (8.5%). The only significant variable found between patients who did and did not have complications was the presence of a BiVICD (81.8 vs 48.7%, P = 0.036). Of the 40 total patients who underwent lead extraction, all three complications occurred in patients with BiVICDs. Conclusion: The number of prophylactic Fidelis® lead revisions has increased dramatically since 2008, and procedure‐related complications have been higher than anticipated. Major procedural complication rates are greater among patients with BiVICDs. Overall, lead extraction does not appear to increase procedural risk as compared to abandonment. (PACE 2012; 35:665–671)     

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)     

Clopidogrel increases bleeding complications in patients undergoing heart rhythm device procedures

Background: Management of antiplatelet therapy at the time of device implantation remains controversial. This study aimed to assess the risk of bleeding complications in patients receiving clopidogrel at the time of cardiac device surgery. Methods: We performed a retrospective case‐control study. Between 2004 and 2010, 101 consecutive patients receiving clopidogrel underwent cardiac device surgery (pacemaker or implantable cardioverter–defibrillator implantation, and generator replacement) in our institution. Controls were 1:1 matched on age, sex, device, type of procedure, number of leads implanted, and venous approach (cephalic or subclavian). A significant bleeding complication was defined as pocket hematoma requiring surgical evacuation or prolonged hospitalization, hemothorax, pericardial effusion, or tamponade. Results: Bleeding complications occurred more frequently in patients receiving clopidogrel at the time of device procedure: 11.9% versus 4.0% (P = 0.037; odds radio [OR] 3.27 [1.02–10.5]). Significant bleeding complications were noted in 12 patients (11.9%) receiving clopidogrel, including two patients with pericardial effusion and one patient with hemothorax. Four controls (4.0%) had bleeding complications (three pocket hematomas and one pericardial effusion). The single factor associated with increased bleeding complications in patients receiving clopidogrel was subclavian puncture (P = 0.008). In the entire cohort (n = 202), multivariate analysis identified two independent predictors of significant bleeding complications: clopidogrel treatment at the time of surgery (P = 0.03; OR 3.7 [1.1–12.6]) and subclavian venous puncture (P = 0.03; OR 3.44 [1.1–10.4]). Conclusions: Clopidogrel treatment at the time of heart rhythm device procedures is associated with an increased risk of significant bleeding complications. Subclavian puncture seems to strongly increase hemorrhagic complications in this setting. (PACE 2012; 1–7)     

Transfemoral Snaring and Stabilization of Pacemaker and Defibrillator Leads to Maintain Vascular Access During Lead Extraction

Background: Lead extraction is an effective method for removing pacemaker and defibrillator leads and to obtain venous access when central veins are occluded. Objective: We report a series of patients who required lead extraction and preservation of vascular access requiring a vascular snare introduced from the femoral vein to provide traction on the lead. This technique allowed advancement of the extraction sheath beyond the level of vascular occlusion, preserving vascular access in all patients. Methods: All patients had peripheral contrast venography performed immediately prior to the procedure to identify the site(s) of venous occlusion. An extraction sheath was employed and with direct manual traction, the lead tip pulled free from the myocardial surface prior to advancement of the sheath beyond the occlusion. A transfemoral snare was used to grasp the distal portion of the lead and traction was used to immobilize the lead. Results: In all patients, transfemoral snaring of the leads was necessary to allow safe advancement of a sheath to open the occluded venous system. There were no complications in any of the patients. Conclusion: Our series demonstrates the simple and safe technique of transfemoral lead snaring to assist lead extraction and maintain vascular access in the setting of venous occlusion, when the distal lead tip pulls free of the myocardium before an extraction sheath is passed beyond the point of venous obstruction.     

Subclavian Crush Syndrome Complicating Transvenous Cardioverter Defibrillator Systems

Subclavian crush syndrome, described with pacemaker leads implanted via subclavian puncture, may occur when conductor fractures and insulation breaches develop by compression of a lead between the first rib and clavicle. We reviewed our experience in 164 patients who underwent intended implantation of transvenous defibrillator systems to determine the clinical relevance of subclavian crush syndrome in defibrillator patients. Venous access was obtained via subclavian puncture in 114 patients (70%) and via cephalic cut-down in 50 patients (30%). Nonthoracotomy lead systems, with or without subcutaneous patch, were successfully implanted in 131 of 164 patients (79.9%). Thoracotomy was required in 32 patients (19.5%) and subxiphoid patch in 1 patient (0.6%). Over a mean of 12.9 months (range 1–62 months), 3 patients (1.8%) required revision of the rate sensing lead/coil or superior vena cava coil after development of lead compression fractures in the region of the clavicle and first rib. In all 3 patients the leads had been implanted via subclavian puncture (2.6% of patients in whom the subclavian technique was utilized). Two patients presented with spurious shocks. One patient was asymptomatic. Conclusions: When venous access is obtained via subclavian puncture, subclavian crush syndrome may develop in patients with transvenous defibrillator systems. Patients may be asymptomatic and lead fractures may go unrecognized. When implanting transvenous defibrillator systems, strong consideration should be given to obtaining venous access primarily via the cephalic cut-down technique.     

Prevalence of venous anatomic variants and occlusion among patients undergoing implantation of transvenous leads

BACKGROUND: The implantation of transvenous leads may be prohibited by venous occlusion or anatomical variants. The prevalence of these conditions among patients undergoing transvenous pacing or implantable cardioverter defibrillator (ICD) leads implantation has not been systematically studied. This study examined the prevalence of venous anatomic variants and/or venous occlusion, and related risk factors, prior to lead implantation. METHOD: The study included 273 consecutive patients scheduled for implantation of transvenous pacing or ICD leads. Before the procedure, the venous network of arms, neck, and thorax was evaluated by bilateral intravenous digital subtraction angiography (DSA). RESULTS: Complete venous occlusion associated with developed collateral circulation was observed in 12 patients (4.4%); at the site of the left innominate vein in 9, left subclavian vein in 2, and right subclavian vein in 1 patient. Of 12 patients with venous occlusion, 7 patients had a history of prior surgical procedure. A persistent left superior vena cava was observed in 1 patient (0.4%). The presence of abnormal findings on DSA was significantly higher on the left than the right side (P < 0.001). The cardio-thoracic ratio (CTR) was significantly greater in patients with venous occlusions than patients with normal circulation (P = 0.012). CONCLUSIONS: Asymptomatic venous abnormalities are not rare among patients requiring transvenous pacing lead implantation. Careful attention should be paid when implanting pacing or ICD leads from the left side, especially in patients with an increased CTR or history of prior insertion for central venous catheter.     

Placement of transvenous pacemaker and ICD leads across total chronic occlusions

OBJECTIVE: To establish a method of implantation for device leads across total venous occlusions. BACKGROUND: Indications for pacemaker and implantable cardiac defibrillator implantation continue to expand. Chronic venous occlusions are increasingly encountered with lead placement. Some degree of obstruction can be as high as 13% before device implantation and 50% after transvenous device implantation. We report an approach of venoplasty/dilatation of chronic total occlusions to allow lead placement. METHODS: From January 1, 2002 through December 16, 2004, 1,356 systems (initial and upgrade) were implanted at the University of Virginia. At the time of device implant, seven patients were noted to have chronic venous occlusions and alternative access was precluded. Four of the seven patients had an existing system; the other three received initial implantations. Subsequently, these seven patients had a 5 Fr catheter placed in the basilic/axillary/subclavian vein and a venogram was obtained to demonstrate the area of chronic occlusion. A guide wire was advanced across the lesion for initial recanalization. Dilatation or venoplasty was performed at the occluded site. A guide wire was retained across the lesion and the patient underwent lead implantation. RESULTS: In all seven patients, recanalization was achieved and leads were successfully placed. There were no complications or damage to the vessels or existing leads. CONCLUSIONS: Venoplasty or dilatation of chronic total venous occlusion is a safe and effective technique, which allows for placement of transvenous leads.     

Opportunistic access: Successful retrograde guide wire advancement to the pocket through a track created by laser lead extraction

Obtaining vascular access can be difficult following lead extraction if a wire is not retained within the vessel. We describe a unique situation in which retrograde passage of a guidewire to the explanted internal cardioverter/defibrillator pocket facilitated regaining subclavian venous access.     

Evolution in transvenous extraction of pacemaker and implantable cardioverter defibrillator leads using a mechanical dilator sheath

Background: With developing technology, transvenous lead extraction (TLE) has undergone an explosive evolution due to incremental problems related to lead infection and malfunction. Objective: We aimed to present our experience in TLE with the Evolution®Mechanical Dilator Sheath (Cook Medical, Grandegrift, PA, USA). Methods: Between June 2009 and July 2011, the Evolution®mechanical dilator sheath was used for the extraction of 140 pacemaker (PM) and implantable cardioverter‐defibrillator (ICD) leads in 66 patients. Indications for extraction, procedural success, and complications were defined according to Heart Rhythm Society Guidelines. Results: Indications for TLE were infection in 39 patients (59.1%), lead malfunction in 26 patients (39.4%), and lead displacement in one patient (1.5%). Extracted devices were PM in 28 cases (42.3%), ICD in 26 cases (39.4%), and biventricular cardioverter defibrillator in 12 cases (18.2%). Among 140 leads, 31 (22.1%) were right ventricular, 49 (35.0%) were defibrillator coil, 47 (33.6%) were atrial, and 13 (9.3%) were coronary sinus electrodes. The median time interval from the lead implantation to lead extraction was 85 months (range 22–240 months). Complete procedural success with the Evolution®system alone was achieved in 58 (87.9%) patients and overall clinical success was 98.5%. Four leads were completely removed with the help of a femoral snare and partial success was achieved in three leads with a remaining small ventricular tip. Major complication was observed in only one (1.5%) patient without any mortality. Conclusions: Our experience confirms that the hand‐powered Evolution system is an effective extraction tool for chronically implanted PM/ICD leads. Randomized controlled studies are required to evaluate success and complication rates in comparison to other techniques. (PACE 2012;XX:1–7)     

Subclavian venoplasty may reduce implant times and implant failures in the era of increasing device upgrades

Background: The incidence of subclavian venous occlusions (SCVOs) may be an increasing problem in the era of device upgrades, especially to cardiac resynchronization therapy. Venoplasty (VP) performed by the electrophysiologist as a way of managing SCVOs may be advantageous. Methods: We reviewed the implantable cardioverter defibrillator (ICD) implants of the past 5 years at Montefiore Medical Center and searched for SCVOs that required intervention and compared cases where VP was performed with cases where it was not. Results: Of 1,853 ICD implants, 41 SCVOs (2.2%) requiring intervention were identified. Its incidence increased seven‐fold from 0.7% in 2005 to 5.2% in 2009. Twenty‐seven of the 41 SCVOs were found during a device upgrade. Of these 41 SCVOs, 18 underwent VP and 23 did not. In the VP group, there was a trend towards a shorter total procedure time, 2:31 hours versus 3:28 hours (P = 0.37), and the total fluoroscopy time was 30 minutes versus 27 minutes (P = 0.55). VP was successful in all 18 patients. Among the non‐VP group (n = 23), five (21.5%) had a failed implantation because of the inability to gain venous access and 10 (42.7%) had to be implanted on the contralateral side. Conclusion: The incidence of SCVOs requiring intervention is increasing in the era of device upgrades. VP performed by an electrophysiologist appears to be a safe and efficient approach to manage these SCVOs. VP seems to reduce the implant time and the need to implant on the other side as well as implant failure due to the inability to gain venous access. PACE 2012; 35:444–448)     

Performance Evaluation of a Right Atrial Automatic Capture Verification Algorithm using Two Different Sensing Configurations

Background: This acute data collection study evaluated the performance of a right atrial (RA) automatic capture verification (ACV) algorithm based on evoked response sensing from two electrode configurations during independent unipolar pacing. Methods: RA automatic threshold tests were conducted. Evoked response signals were simultaneously recorded between the RA_Ring electrode and an empty pacemaker housing electrode (RA_Ring→Can) and the electrically isolated Indifferent header electrode (RA_Ring→Ind). The atrial evoked response (AER) and the performance of the ACV algorithm were evaluated off‐line using each sensing configuration. An accurate threshold measurement was defined as within 0.2 V of the unipolar threshold measured manually. Threshold tests were designed to fail for small AER (< 0.35 mV) or insufficient signal‐to‐artifact ratio (SAR < 2). Manual threshold measurements were obtained during RA unipolar and bipolar pacing and compared across device indications. Results: Data were collected from 38 patients with RA bipolar leads from four manufacturers. AER signals were analyzed from 34 patients who were indicated for a pacemaker (five), implantable cardioverter‐defibrillator (11), or cardiac resynchronization therapy pacemaker (six) or defibrillator (12). The minimum AER amplitude was larger (P < 0.0001) when recorded from RA_Ring→Can (1.6±0.9 mV) than from RA_Ring→Ind (1.3±0.8 mV). The algorithm successfully measured the pacing threshold in 96.8% and 91.0% of tests for RA_Ring→Can and RA_Ring→Ind, respectively. No statistical difference between the unipolar and bipolar pacing threshold was observed. Conclusions: The RA_Ring→Can AER sensing configuration may provide a means of implementing an independent pacing/sensing method for ACV in the RA. RA bipolar pacing therapy based on measured RA unipolar pacing thresholds may be feasible.     

Prospective Randomized Comparison of the Safety and Effectiveness of Placement of Endocardial Pacemaker and Defibrillator Leads Using the Extrathoracic Subclavian Vein Guided by Contrast Venography Versus the Cephalic Approach

CALKINS, H., et al. : Prospective Randomized Comparison of the Safety and Effectiveness of Placement of Endocardial Pacemaker and Defibrillator Leads Using the Extrathoracic Subclavian Vein Guided by Contrast Venography Versus the Cephalic Approach. The purpose of this prospective randomized study was to compare the safety and efficacy of the cephalic approach versus a contrast-guided extrathoracic approach for placement of endocardial leads. Despite an increased incidence of lead fracture, the intrathoracic subclavian approach remains the dominant approach for placement of pacemaker and implantable defibrillator leads. Although this complication can be prevented by lead placement in the cephalic vein or by lead placement in the extrathoracic subclavian or axillary vein, these approaches have not gained acceptance. A total of 200 patients were randomized to undergo placement of pacemaker or implantable defibrillator leads via the contrast-guided extrathoracic subclavian vein approach or the cephalic approach. Lead placement was accomplished in 99 of the 100 patients randomized to the extrathoracic subclavian vein approach as compared to 64 of 100 patients using the cephalic approach. In addition to a higher initial success rate, the extrathoracic subclavian vein medial approach was determined to be preferable as evidenced by a shorter procedure time and less blood loss. There was no difference in the incidence of complications. In conclusion, these results demonstrate that lead placement in the extrathoracic subclavian vein guided by contrast venography is effective and safe. It was also associated with no increased risk of complications as compared with the cephalic approach. These findings suggest that the contrast-guided approach to the extrathoracic portion of the subclavian vein should be considered as an alternative to the cephalic approach.     

ICD Lead Implantation Following Sharp Cannulation of a Blocked Superior Vena Cava

Blocked superior vena cava (SVC) presents a well‐recognized problem for the implantation of device leads. Implantable cardioverter defibrillator (ICD) leads pose a greater challenge than the pacing leads by requiring an adequate shock vector for successful defibrillation. We present here a novel technique of opening the blocked SVC to facilitate ICD lead implantation through the upper venous system. (PACE 2011; 34:e82–e84)     

ICD Implantation after Crossing a Totally Occluded Subclavian Vein Via Collaterals from the Superior Vena Cava

Placing an implantable cardioverter‐defibrillator is a challenge in the presence of bilateral venous obstruction of the upper extremities. We describe a case where venous access was obtained by passing a hydrophilic wire from the superior vena cava through collaterals to the infraclavicular region. (PACE 2010; 33:e14–e16)     

Implantation of Cardioverter Defibrillator and Pacemaker Using the Same Pectoral Quadrant

We implanted a cardioverter defibrillator (ICD) together with a pacemaker system in three patients with ventricular tachycardia and bradyarrhythmias. Both systems (ICD and pacemaker) were implanted in the same left pectoral quadrant using a single skin incision and the subclavian and/or the cephalic vein. The ICD was implanted deep to the pectoralis major muscle, the pacemaker was placed subcutaneously in a more medial pocket. There were no technical difficulties during implantation or complications during follow-up.     

Transcatheter Leadless Cardiac Pacing in Renal Failure with Limited Venous Access

Entirely leadless cardiac pacemakers that are delivered transvenously required the use of large‐diameter delivery sheath and femoral venous approach. The complexity of external femoral and iliac venous anatomy may limit their implantation. We describe a hemodialysis patient without subclavian venous access and a conventional pacemaker with a failed right ventricular lead, who had difficult iliac venous anatomy that was also compressed by an external endovascular abdominal aortic stent. Successful leadless pacing using a Micra? (Medtronic Inc., Minneapolis, MN, USA) was accomplished with a strong support wire, hydrophilic delivery sheath, and guided by venography.