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LEADLESS PACEMAKER AND SUBCUTANEOUS ICD

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ADVANCES IN PACEMAKER

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LEADLESS PACEMAKER AND SUBCUTANEOUS ICD

  1. 1. SUBCUTANEOUS ICD’S & LEADLESS PACEMAKER SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  2. 2. OUTLINE • INTRODUCTION • S-ICD • LEADLESS PACEMAKER • FUTURE PERSPECTIVE • SUMMARY SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  3. 3. INTRODUCTION • Sudden cardiac death (SCD) resulting from cardiac arrhythmia is the world's leading cause of cardiovascular mortality, accounting for over 50 percent of cardiovascular deaths worldwide • Conventional transvenous ICD (TV-ICD) systems come with the inherent drawbacks of transvenous leads, including: – Risks at the time of insertion – cardiac perforation, pericardial effusion, cardiac tamponade, hemothorax, pneumothorax – Delayed risks over the lifetime of the device – intravascular lead infection, lead failure • The subcutaneous ICD (S-ICD) has been developed in an attempt to minimize some of the limitations of TV-ICD systems by avoiding endovascular access entirely SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  4. 4. REQUIREMENTS FOR AN ICD SYSTEM Effective Defibrillation • Deliver adequate energy with an adequate safety margin to defibrillate. • Deliver this energy in a sufficiently short time to minimize syncope while still allowing the possibility of spontaneous termination. Effective VT/VF Sensing • Appropriate sensing of ventricular events at high rates while not oversensing non-ventricular/non-cardiac events. • Adequately distinguishing VT/VF events from supraventricular arrhythmias. • Safe ICD System Implantation. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  5. 5. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER The current S-ICD was originally conceived in 1994 by Dr. Gust Bardy July 28, 2008 First Human Implant by Dr. Margaret Hood and Dr. Warren Smith (Duke EP Alum) in New Zealand
  6. 6. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER N Engl J Med 2010;363:36-44.
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  9. 9. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER Weighs 145 g Volume 69 ml Battery 5 years Data per episode 120 sec Max data storage 24episodes
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  11. 11. COMPONENTS OF S-ICD • As with a standard transvenous ICD (TV-ICD), the S-ICD is comprised of a pulse generator and a shocking lead • The pulse generator is implanted in a subcutaneous pocket in the left lateral, mid-axillary thoracic position. • The subcutaneous lead, which toward its terminal end contains an 8-cm shocking coil electrode, is tunneled from the pulse generator to a position along the left parasternal margin. • There are proximal and distal sensing electrodes within the lead that flank the 8-cm shocking coil. • The distal electrode sits just below the sternal notch, and the proximal electrode lies just above the xiphoid process. • The cardiac rhythm is detected via a wide bipole between the two sensing electrodes or between one of the sensing electrodes and the pulse generator SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  12. 12. S-ICD IMPLANTATION SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
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  14. 14. S-ICD Sensing Lead Vectors SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  15. 15. FUNCTIONING OF S-ICD • The S-ICD system detects changes in ventricular rate by using modified subsurface electrocardiography through either a primary, secondary, or alternate vector • The device uses proprietary algorithms to automatically determine the optimal sensing vector based on an R- to T- wave ratio that avoids double QRS counting or T-wave oversensing. • It measures the heart rate as the rolling average of 4 consecutive sensed intervals, recognizing ventricular fibrillation (VF) when 18 of 24 consecutive sensed events exceed a pre-determined nonprogrammable detection zone limit. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  16. 16. EFFECTIVE SENSING • Primarily rate sensing (common to all ICDs) SICD Arrhythmia Discrimination Criteria • Correlation between current beat and stored template – if < 50% favors VT • Continuous beat-to-beat correlation – if polymorphic favors VT – • Continuous beat-to-beat QRS width – if wide QRS is noted during monomorhpic relationship, favors VT SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  17. 17. • The device then charges its capacitors to deliver a biphasic-waveform defibrillating pulse of up to 80 J. • The S-ICD can provide post-shock bradycardia ventricular pacing support for 30 s, activated only after more than 3.5 sec of post shock asystole. • If vt or vf persists following the initial shock, the device will reverse polarity between the electrodes and deliver subsequent shocks. • The s-icd will deliver a maximum of five shocks for a single episode of a ventricular arrhythmia. • It can reverse shock polarity if the initial shock is unsuccessful • During an event, the s-icd will store the electrocardiogram (ecg) tracing for subsequent review SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  18. 18. Eligibility For S-ICD SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
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  20. 20. Placement of the surface electrodes during screening SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
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  22. 22. When To Consider The S-ICD There are no formal guidelines for the selection of an S-ICD system. 1. S-icds may be considered in younger patients due to the expected longevity of the implanted leads and a desire to avoid chronic transvenous leads. 2. S-icd system might be an appropriate consideration in patients with hypertrophic cardiomyopathy, congenital cardiomyopathies, or inherited channelopathies. 3. S-icds may also be considered in patients at high risk for bacteremia, such as patients on hemodialysis or with chronic indwelling endovascular catheters. 4. Patients with challenging vascular access or prior complications with tv-icds may be considered for s-icds. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  23. 23. WHEN TO AVOID THE S-ICD S-ICDs provide neither antitachycardia pacing as a therapy for ventricular arrhythmias nor continuous bradycardia pacing in the event of symptomatic bradyarrhythmias. • Recurring ventricular tachycardia (vt) that is reliably terminated with anti-tachycardia pacing (atp) • In patients with sinus node dysfunction, atrioventricular block. • S-ICD s are not indicated in patients requiring biventricular pacing for cardiac resynchronization therapy. • Unipolar pacing from a coexisting device is contraindicated SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  24. 24. S-ICD Candidate Selection + FAVORABLE FACTORS RELATIVE CONTRAINDICATIONS Young and active Recurrent monomorphic VT CHD that limits lead placement Bradycardia requiring pacing Indwelling catheters Indication for CRT Immunocompromsed High risk for VT( sarcoidosis, ARVD) Inherited channelopathies Preference for remote monitoring SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER +S-ICD :is it the future? Chapter 159; cardiac update by dr.o.sai satish md dm
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  26. 26. EFFICACY OF S-ICD SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  27. 27. COMPARISON WITH TV-ICD • In the START (Subcutaneous versus Transvenous Arrhythmia Recognition Testing) trial, which compared simulated sensing performance of the S-ICD with that of standard TV-ICDs in 64 patients, both S-ICD and TV-ICD devices were successful in detecting 100 % of ventricular arrhythmias. • In this trial, the S-ICD also had greater success in discriminating supraventricular tachycardias from ventricular tachycardias (VTs) (98 % S- ICD versus 76.7 % for single-chamber TV-ICD versus 68 % for dual- chamber TV-ICD) • In a case-control study of 69 patients with S-ICD who were matched with control patients with TV-ICDs, successful conversion of induced ventricular fibrillation (VF) occurred in 89.5 percent of initial shocks delivered by S-ICD (95.5 percent including reverse polarity defibrillation), compared with 90.8 percent success in conversion with traditional TV-ICD SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
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  29. 29. PRAETORIAN Trial • Currently is underway and should be the first multicenter, randomized trial to directly compare S-ICDs with TV-ICD. • The study is designed to enroll a total of 700 patients, powered to prove non-inferiority of the S-ICD with the composite primary endpoint being inappropriate shocks and ICD-related complications, along with secondary endpoints of shock efficacy and patient mortality SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  30. 30. POTENTIAL COMPLICATIONS SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
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  34. 34. Inappropriate Shocks SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER • Most common and concerning complications seen with s-icds,( 4 to 16%). • The majority of inappropriate shocks are due to oversensing (85%) most frequently of cardiac signals (94% of over sensed episodes) mainly consisting of T waves or low amplitude signals. • Most common cause for inappropriate shocks from S-ICD’s is oversensing of t- waves, for tv-icd systems, due to supraventricular arrhythmias or lead malfunction . • Inappropriate sensing of myopotentials from chest muscle activity may also be a source of inappropriate shocks. • Inappropriate shocks are more likely to occur in younger, physically active patients, who are also those commonly selected for placement of an S-ICD system.
  35. 35. Proportion of appropriate and inappropriate therapies and their etiologies SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
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  37. 37. • A preimplantation surface electrocardiogram (ECG) screening tool has also been developed to minimize the number of patients at risk for inappropriate shock due to T-wave oversensing error. • The tool identifies patients who have large and or late T-waves relative to the QRS using three vectors that mimic the device sensing vectors. • Studies suggest that between 8 and 15 percent of patients are ineligible for an S-ICD due to susceptibility to T-wave oversensing and thus high risk of inappropriate shocks. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  38. 38. • The programming of an arrhythmia discrimination zone can reduce the frequency of inappropriate S-ICD shocks due to supraventricular arrhythmias. • Inappropriate shocks due to oversensing may be minimized by appropriate patient screening prior to implantation and appropriate device programming following implantation. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  39. 39. Pocket Infections • 1 to 10 % of S-ICD recipients , 1 to 4% requiring device explantation. • The rate of pocket infection with the S-ICD exceeds that with the T-ICD. • The 3 incisions required for s-icd implantation provide a greater probability for bacterial entry. • The increased bulk of the s-icd may exert more pressure on the skin and increase the risk of tissue necrosis and erosion. • S-icd infections can be treated conservatively with a course of antibiotics. • S-icd device does not contain any endovascular leads, the risk of infection causing bacteremia/endocarditis is reduced. • The infection rate may decrease with more operator experience, introduction of smaller pulse generators, and use of a 2-incision technique for system implantation. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  40. 40. Lead Movement • Lead dislodgement or migration had been noted to occur in( 3 to 11%). • Lead dislodgement or migration results from vigorous physical activity occurring without adequate fixation of the parasternal lead. • Requires reoperation to reposition the lead. • Suture sleeves are now used to anchor the proximal segment of the parasternal lead SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  41. 41. • Other less common complications that may require reintervention may include – skin erosion, – premature battery depletion, – explantation due to need for antitachycardia/bradycardia pacing or a new indication for resynchronization therapy • Complication rates have been shown to improve as operators and centers gain experience with S-ICD implantation. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  42. 42. APPROACH TO S-ICD DEVICE SELECTION 1. Does the patient have an indication for antitachycardia pacing or known to respond to antitachycardia pacing? 2. Does the patient have an indication for standard transvenous pacing? 3. Is the patient a candidate for biventricular pacing and cardiac resynchronization therapy? 4. Is the patient relatively young with anticipated prolonged ICD therapy or multiple ICD systems in the course of one’s lifetime? 5. Does the patient have other indwelling venous catheters or leads? 6. Is the patient at high risk for systemic infection? SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  43. 43. Algorithm for choosing subcutaneous ICD SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  44. 44. Advantages of S-ICD 1. obviates some of the mechanical complications associated with transvenous lead implantation (eg, cardiac perforation leading to pericardial effusion and cardiac tamponade, hemothorax, pneumothorax, endovascular lead infection) 2. solid core design of the S-ICD lead and its lack of exposure to the repeated mechanical stresses of myocardial contraction improves lead durability when compared with transvenous ICD (TV-ICD) leads. 3. No transvenous lead 4. Fluoroscopy not required for implant 5. Ultra far field signals for arrhythmia discrimination. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  45. 45. 6. The S-ICD system delivers energy to the heart in a more homogenously distributed pattern than the endocardial shock delivered by the T-ICD . 7. Endocardial shocks produce significant troponin release; shocks delivered from subcutaneous electrodes do not. • The uneven distribution of energy across the myocardium after an endocardial shock can produce voltage gradients and electroporation resulting in myocardial stunning and damage. • Myocardial injury and stunning associated with ICD discharge might explain the increased mortality seen in heart failure patients receiving multiple shocks. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  46. 46. Limitations of S-ICD 1. Does not provide pacing for bradyarrhythmias 2. CRT is not available 3. No ATP 4. No atrial lead for monitoring of atrial tachyarrhythmias 5. No remote monitoring 6. Larger size 7. Long charge times 8. Battery life is shorter approximately 5 years 9. NO mortality data or long term experioence 10. 80J shock 11. Inappropriate shocks, might be associated with reduced longevity and quality of life SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  47. 47. Future of S-ICD • The S-ICD is a promising technology that could fill a gap in the treatment of ventricular tachyarrhythamias by extending this vital therapy to patients in countries where the facilities to implant T-ICDs are not available. • Indeed, if this new device that is based on simplicity and ease of implan- tation can be deployed at less cost and with non inferior clinical outcomes, it could become a breakthrough therapy. • But it is a new technology and, as such, requires the scrutiny of a comparative effectiveness trial. • Only then can we tell patients that it is as effective as existing ICDs. Otherwise, a fully informed patient who is offered this device today should not want one. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  48. 48. CONCLUSIONS . • The clinical experience from the introduction of the S-ICD system underscores its role as a reliable alternative for pre- venting SCD. The exclusive use of a subcutaneous lead for sensing and defibrillation represents the greatest advantage of this novel technology; the S-ICD eliminates the draw- backs associated with endovascular electrodes. However, the lack of demand bradycardia or anti-tachycardia pacing limits its utility in patients with conduction system disease or pace-terminable VT. The first- generation device raises concerns about an increased risk of pocket infection, battery longevity, and inappropriate shocks compared with the newest T-ICD systems. No study to date directly compared the T-ICD and the S-ICD in patients indicated for ICD therapy as primary prevention of SCD. The clinical expe- rience does suggest that its use be considered in relatively SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  49. 49. LEADLESS PACEMAKER SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  50. 50. • In response to the limitations of both transvenous and epicardial pacing systems, efforts have been made to develop leadless cardiac pacing systems. • leadless systems have a self-contained system which includes both the pulse generator and the electrode within a single unit that is placed into the right ventricle via a transvenous approach. • Leadless cardiac pacing systems have been approved for use in Europe since 2013, and in April 2016, the first leadless cardiac pacing system was approved for use in the United States SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  51. 51. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER MICRA NANOSTIM
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  53. 53. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER NANOSTIM LEADLESS CARDIAC PACEMAKER
  54. 54. MICRA TRANSCATHETER PACING SYSTEM SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
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  59. 59. CLINICAL TRAILS SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  60. 60. LEADLESS Trial • The, a first-in-human, single-arm, multicenter study of the safety and clinical performance of the LCP. • patients were considered eligible if they had indications for single-chamber, right ventricular pacing (VVI [R]). Indications included: 1) permanent atrial fibrillation with atrioventricular block (including atrial fibrillation with a slow ventricular response). 2) normal sinus rhythm with second- or third-degree atrioventricular block with a low level of physical activity or short expected life span. 3) sinus bradycardia with infrequent pauses or un- explained syncope with electrophysiologic findings. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  61. 61.  Thirty-three patients were enrolled in the LEADLESS trial.  The implantation success rate was 97% (32 of 33 patients),  the mean procedure duration was 28 +/-17 min  the overall complication-free rate was 94% (31 of 33 patients). The 1-year follow-up results of the LEADLESS trial were recently reported and demonstrated that: 1) performance measures (pacing threshold, impedance, and sensing) remained stable; 2) there were further no complications related to the device (beyond the index procedure); 3) there were no premature battery depletions or under/oversensing issues; 4) adequate rate response, defined as 80% of the predicted maximal heart adjusted for age, was observed in those patients for whom it was activated SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  62. 62. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER n engl j med 373;12 :September 17, 2015
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  64. 64. • In the leadless II trial, a prospective, non-randomized, multicenter trial of self-contained leadless device (nanostim leadless cardiac pacemaker , st. Jude medical ) enrolled patients with an indication for single chamber RV pacing. • 93 % met the primary efficacy endpoint of acceptable pacing capture threshold (<2v at 0.4 milliseconds) and sensing amplitude (R wave ≥5 mv). • The primary safety endpoint (freedom from device-related adverse events) was also achieved in 93 percent of patients (280 out of 300). • On the basis of the observed device-use conditions (e.g Heart rate, percentage of ventricular pacing, and pacing impedance) of the 300-patient cohort followed for 6 months, the battery longevity is estimated to be 15.0±6.7 years SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  65. 65. Complications of conventional and leadless pacemaker LEADLESS PACEMAKER (6.7%) • Device dislodgement in 1.7% • Cardiac perforation in 1.3% • Elevated pacing thresholds requiring device retrieval and re implantation in 1.3% • Vascular complications in 1.3% CONVENTIONAL VENTRICULAR PACEMAKERS (3.2%) • Pneumothorax in 1.1% • Lead dislodgement in 0.8% • Infection in 0.5% • Cardiac perforation 0.6 to 5.0% SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  66. 66. LIMITATIONS • This pacemaker was safely retrievable; however, most of the devices that were retrieved were explanted within 1 year after implantation, and there are few data on the feasibility of the removal of leadless cardiac pacemakers beyond this point • This study was limited by the observational design that did not directly compare the leadless cardiac pacemaker with conventional pacemakers, thereby limiting our ability to draw conclusions about the relative safety and efficacy of these devices. • Furthermore, the mean follow-up was only 6 months, again limiting understanding of long-term efficacy and pacemaker-related complications, particularly in comparison with conventional pacemaker systems. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  67. 67. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER n engl j med 374;6 February 11, 2016
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  69. 69. • In the Micra Transcatheter Pacing Study, which enrolled 725 patients with an indication for single chamber RV pacing, the leadless device was successfully placed in 719 patients (99.2 percent). • The primary safety end point was freedom from system-related or procedure- related major complications. The primary efficacy end point was the percentage of patients with low and stable pacing capture thresholds at 6 months (≤2.0 V). • The Kaplan-Meier estimate of freedom from device-related adverse events at six months was 96 percent. • The second primary endpoint, <2V mean pacing capture threshold at 0.24 millisecond pulse width, was assessed at six months in a subset of 297 patients, among whom 292 (98.3 percent) reached the primary endpoint SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  70. 70. POTENTIAL BENEFITS OF LEADLESS CARDIAC PACING 1. Mitigates the risk of complications of transvenous lead. 2. Inherent benefit of preventing intrasystem connection errors because the pulse generator pace/sense electrodes are a single unit. 3. The single-component systems do not require a surgical incision/subcutaneous pocket, which mitigates the risk of surgical complications and may provide a more favorable cosmetic profile. 4. Smaller size. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  71. 71. 5. LCP have projected battery longevity that is comparable to that of standard single-chamber transvenous pacemakers. Less internal current drain ,approximately 1mA The lack of “lost” energy through the lead High-density lithium carbon monofluoride battery Use of energy-efficient conductive (vs. Inductive) telemetry 6. The LCP and TPS are also believed to be safe for use with magnetic resonance imaging, because of their lack of ferrous material 7. There is potentially less radiation exposure for the implanting physician. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  72. 72. POTENTIAL LIMITATIONS OF LEADLESS CARDIAC PACING 1. Most important limitation is their ability to perform only single-chamber pacing, specifically right ventricular pacing , not appropriate for patients with sinus node dysfunction. 1. Chance of device embolization with single- component systems. 1. The optimal fixation mechanism, with regard to both chronic performance and the need for future extraction, remains to be seen. 1. The portion of the device that interacts with the endocardium has a wider diameter, which has raised the possibility of proarrhythmia. 2. Although leadless pacemakers are reportedly retrievable acutely, the ability to remove a chronically-implanted device remains untested in humans. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  73. 73. 5. The larger caliber of the delivery units has the potential to increase complications related to either the femoral access site or catheter manipulation within the right ventricle.(Large venous 24-F for the TPS and 18-F for the LCP) 6. As such, the strategy for device management (retrieval vs. Abandonment) once the battery has been depleted remains to be determined. 7. The leadless cardiac pacemaker also cannot provide electrographic data. 8. Higher chance of Perforations related to leadless cardiac pacemakers due to the relatively large diameter of the device. 9. Special training will be required to develop proficiency in lcp implantation. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  74. 74. CONCLUSIONS Leadless cardiac pacing holds promise as a long-term permanent cardiac pacing option for patients requiring single ventricle (RV only) pacing. • However, longer-term follow-up is needed to assess the safety and efficacy of these devices. • The potential for and incidence of long-term deleterious effects of pacing only the RV will also need to be assessed. • Randomized clinical trials will be necessary to definitively determine whether the theoretical benefits of leadless systems will be superior to those of conventional pacemakers both from a safety perspective and in terms of long-term pacing and sensing performance. SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  75. 75. FUTURE PERSPECTIVE SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
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  79. 79. SUMMARY • S-ICD • LEADLESS PACEMAKER SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER
  80. 80. THANK YOU SUBCUTANEOUS ICD'S & LEADLESS PACEMAKER

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