Pacemaker/defibrillator lead extraction: a single centre experience

Transcription

1 Pacemaker/defibrillator lead extraction: a single centre experience Pier Giorgio GOLZIO Division of Cardiology, Department of Internal Medicine University of Turin, Azienda Ospedaliero Universitaria San Giovanni Battista di Torino Molinette Funding: none reported. Conflicts of interest: none stated

2 Introduction Over the last few years, an increasingly widespread use of cardiac implantable electronic devices for treatment of cardiac rhythm disturbances has been closely followed by an increase in the number of cases with device-related complications, mainly infections and malfunctions Staph. epidermidis colonies The ill-fated solar-powered pacemaker

3 Introduction Concurrently, the necessity arose to define more effective and safe techniques for device removal in case of complications This study reports our experience in lead extraction

4 The question.

5 The problem... Adherences! Lead in contact with the vessel wall

6 Location of adherences Scar tissue locations 72% 48% 36% 41% 16% 71% Smith H J et a. PACE 1994; 17: Bongiorni M G et al. Europace 2007;9:69-73

7 Clinical perspective Direct traction can be inconsistent due to scar tissue bonding sites along lead length Pulling a lead without support can cause: stretching breakage or fracture

8 Clinical perspective Force required to extract tined electrodes may be enough to risk avulsion of the myocardium Open heart surgery is associated with significant morbidity and mortality

9 Aim We believed it was appropriate to proceed with a quality assessment of the procedures carried out at our Centre. The decision of carrying out this assessment comes from the awareness, supported by the Guidelines on lead extraction, that in every specialised Centre the optimisation of the operating methods and the necessary level of experience to perform delicate operations are directly proportional to the number of treated patients

10 Patients May 2003 Novembre 2011 Sex N = 316 leads 152 patients N % M F 33 22

11 Patients May 2003 November 2011 Min Max Mean SD Age N of leads Dwelling time (months) N of previous reparative operations

12 Clinical Indications 40 39,6 % , ,2 3,2 0,9 0 Sepsis /endocarditis Pocket infection Chronic draining sinus PM malfunction ICD malfunction Inteference with other systems

13 Lead characteristics % Polarity Insulation Fixation Type Access vein Monopolar 7,8 Bipolar 84,3 Silicon 72,5 Polyurethane 27,5 Pins 84,3 Screw-in, retractable 3,9 Screw-in, fixed 11,8 Atrial 34,3 Ventricular 37,0 VDD 1,4 Coronary sinus 10 ICD 17,4 Left Cephalic 27,1 Right Cephalic 7,8 Left Subclavian 61,2 Right Subclavian 3,9

14 Methods - Extraction protocol Cardiothoracic team on duty Type and cross match blood Continuous monitoring of ECG Continuous monitoring of invasive arterial blood pressure and oxygen saturation Backup pacing Echocardiograph (TT-TE) Intravascular U/sound (not always) Pericardiocentesis set General or local anaesthesia/working anaesthesia equipment

15 Methods - Techniques and tools Manual traction with conventional stylets Dilation with polypropylene sheaths by Cook Vascular Inc. (Leechburg, PA, USA). The size of the sheaths, all provided with bevelled ends, ranged from 7 to 14 F. We used the single-sheath technique, according to Bongiorni (*) Ancillary tools (Lassos, Osypka GmbH, Grentzig- Whylen, Germany; Needle s eye snare, Cook Vascular; Amplaz goose neck snare) (*) Bongiorni, Europace 2008; 29:

16 MULTIPLE APPROACHES ANCILLARY TOOLS

17 MULTIPLE APPROACHES ANCILLARY TOOLS

18 Results - Definitions Complete Procedural Success: removal of all targeted leads and all lead material from the vascular space, with the absence of any permanently disabling complication or procedure related death. Clinical Success: removal of all targeted leads and lead material from the vascular space, or retention of a small portion of the lead that does not negatively impact the outcome goals of the procedure. This may be the tip of the lead or a small part of the lead (conductor coil, insulation, or the latter two combined) when the residual part does not increase the risk of perforation, embolic events, perpetuation of infection or cause any undesired outcome. Failure: inability to achieve either complete procedural or clinical success, or the development of any permanently disabling complication or procedure related death. Transvenous Lead Extraction: Heart Rhythm Society Expert Consensus. Heart Rhythm 2009; 6::

19 Results Success N % Complete ,9 Partial 11 3,5 Failure 2 0,6

20 Sequential results N=316 Manual traction Ineffective N=189 59,8% Effective: N= % Dilation Ineffective: N=2 Efficacy, partial 1,1% Efficacy, overall 0,6% Effective: N=187 Efficacy, partial 98,9% Efficacy, overall 99,4%

21 Procedural times: Definitions Operating-room time: from entry to exit from the operating room Preparative time: from entry into the operating room to skin incision Operation time: skin to skin procedural time Mobilization time: from skin incision to complete mobilization of the lead up to the entry into the vascular space Extraction time: from complete mobilization of the lead up to the entry into the vascular space to complete extraction. It includes two times: Manual traction time: from complete mobilization of the lead up to the vascular access to complete extraction or stopping of the traction due to insuccess and change to dilatation Dilation time: from stopping of the manual traction to complete extraction

22 Variables and operation room times May 2003 November 2011 Variables Min Max M SE SD N of sheaths Operating-room time 0:50:00 6:15:00 3:49:30 0:11:24 1:21:24 Preparative time 0:10:00 3:05:00 1:22:21 0:06:18 0:45:02 Operation time 0:20:00 3:45:00 1:53:14 0:08:00 0:57:10 Mobilization time 0:05:00 1:50:00 0:45:01 0:03:59 0:28:33 Extraction time 0:00:10 2:05:00 0:26:53 0:04:39 0:33:18 Manual traction time 0:00:05 0:05:00 0:00:51 0:00:08 0:00:59 Dilation time 0:02:30 0:45:00 0:16:31 0:02:24 0:11:49 Fluoroscopy time 0:01:00 0:42:00 0:13:52 0:01:32 0:10:59

23 % Reimplantation according to indications 86,5 8, (*) Pearson Chi square p=0.007 (*) p=0.005 (*) ,7 83,3 83,3 13,5 13,9 8,9 5,5 3,1 3,8 88,8 8,8 2,4 Overall Totale Not Non infectious infettive Infectious Infettive Sepsis sepsi infezione decubito Pocket inf. Chronic locale recidivante draining Reimpianto Reimplantation Non Reimplantation reimpianto Già Already reimpiantato sinus not performed reimplanted

24 Pacing modes before and after extraction Pearson s Chi square p= ,5 p= ,6 20,6 p= p= ,9 % 15 14,8 p= ,5 5 0 Not non stimolato reimplanted 5,4 5 3,1 4,1 4,4 2,5 2,2 2,2 1,2 0 VVI VVIR DDD DDDR VDD ICD mono Before extraction Stimolazione pre ICD bi PM CRT ICD CRT Stimolazione After extraction post

25 Complications - Definitions Major Complications 1. Death 2. Cardiac avulsion or tear requiring thoracotomy, pericardiocentesis, chest tube, or surgical repair 3. Vascular avulsion or tear (requiring thoracotomy, pericardiocentesis, chest tube, or surgical repair) 4. Pulmonary embolism requiring surgical intervention 5. Respiratory arrest or anesthesia related complication leading to prolongation of hospitalization 6. Stroke 7. Pacing system related infection of a previously non-infected site Minor Complications 1. Pericardial effusion not requiring pericardiocentesis or surgical intervention 2. Hemothorax not requiring a chest tube 3. Hematoma at the surgical site requiring reoperation for drainage 4. Arm swelling or thrombosis of implant veins resulting in medical intervention 5. Vascular repair near the implant site or venous entry site 6. Hemodynamically significant air embolism 7. Migrated lead fragment without sequelae 8. Blood transfusion related to blood loss during surgery 9. Pneumothorax requiring a chest tube 10. Pulmonary embolism not requiring surgical intervention Transvenous Lead Extraction: Heart Rhythm Society Expert Consensus. Heart Rhythm 2009; 6::

26 COMPLICATIONS Complications % Acute complications Chronic complications Treatment None 90,5 nsvt > 7 beats 1,3 Symptomatic hypotension 1,3 Minor complications Asymptomatic hypotension 5,7 Pericardial effusion 0,6 Cardiac tamponade thoracotomy require DIC death in 2 nd post-operative day Major complications 0,6 None 96,3 Fever 3,7 Volume expansion 14,6 Drugs 11,4 Transfusions 3,5

27 Study RESULTS, COMPLICATIONS AND MORTALITY WITH DIFFERENT TECHNIQUES First cases (1) Accufix (2) Non-Accufix (2) Mechanical dilators. Dilation/countertraction (3) Mechanical dilators. Single sheath, Pisa (4) Laser Registry, USA (5) Laser, European (6) Laser (LEXICON) (7) EDS (8) EDS (9) # of Patients(Pts) and leads (L) 1299 Pts 2195 L 985 Pts 1237 L 1011 Pts 1743 L 2338 Pts 3540 L 1193 Pts 2062 L 1684 Pts 2561 L 292 Pts 383 L 1449 Pts 2405 L 265 Pts 459 L 120 Pts 161 L Dwellig time, years Success, % T P F Major Complications,% Death, % 4,7±3, , ,1±2, ,4-4,5±4, ,5-3,9±3, ,4 0,4 5,75 (0,1-28) 98,4 0,9 0,6 0,8 0,3 5,8±4, ,9 0,8 6,1 (0,2-30) 90,9 3,4 5,7 3,4-6,8 (0,1-29,7) 96,6 2, ,4 0,28 8,4±5.0 95,9 3,5 0,6 2,6 0,6 6,1±1,2 93 3,3 3,7 6,6 -

28 Results, Complications and mortality: References 1. Smith HJ, Fearnot NE, Byrd CL, Wilkoff BL, Love CJ, Sellers TD. Five-years experience with intravascular lead extraction. U.S. Lead Extraction Database. Pacing Clin Electrophysiol Nov;17: Wilkoff BL, Byrd CL, Love CJ, Sellers TD, Van Zandt HJ. Trends in intravascular lead extraction. Analysis of data from 5339 procedures in 10 years. XI th World Symposium on Cardiac Pacing and Electrophysiology. Berlin. Pacing Clin Electrophysiol. 1999;22:A Byrd CL, Wilkoff BL, Love CJ, Sellers TD, Turk KT, Reeves R, et al. Intravascular extraction of problematic or infected permanent pacemaker leads: U.S. Extraction Database, MED Institute. Pacing Clin Electrophysiol Sep;22: Bongiorni MG, Soldati E, Zucchelli G, Di Cori A, Segreti L, De Lucia R, et al. Transvenous removal of pacing and implantable cardiac defibrillating leads using single sheath mechanical dilatation and multiple venous approaches: high success rate and safety in more than 2000 leads. Eur Heart J Dec;29: Byrd CL, Wilkoff BL, Love CJ, Sellers TD, Reiser C. Clinical study of the laser sheath for lead extraction: the total experience in the United States. Pacing Clin Electrophysiol May;25: Kennergren C, Bucknall CA, Butter C, Charles R, Fuhrer J, Grosfeld M, et al. Laser-assisted lead extraction: the European experience. Europace Aug;9: Wazni O, Epstein LM, Carrillo RG, Love C, Adler SW, Riggio DW, et al. Lead extraction in the contemporary setting: the LExICon study: an observational retrospective study of consecutive laser lead extractions. J Am Coll Cardiol Feb 9;55: Love CJ, Byrd CL, Wilkoff BL, Kutalek SP, Schaerf R, Goode LB, et al. Leads extraction using a bipolare electrosurgical dissection sheaths: an interim report. Europace 2001, copenhagen, Denmark, June 24-27, : Neuzil P, Taborsky M, Rezek Z, Vopalka R, Sediva L, Niederle P, et al. Pacemaker and ICD lead extraction with electrosurgical dissection sheaths and standard transvenous extraction systems: results of a randomized trial. Europace Feb;9:

29 RISK SCORE OF MAJOR COMPLICATIONS NR: not reported; NS: not significant;?: possible, doubtful Factor RR Significance Operator # of procedures < 30 procedures (Laser) (1) NR 0,005 related Years of experience Within 3 years (2) 2,8 NS Procedure > 10 yearsi (3) NR related Dwelling time > 5 years (4) 3,25 NS Patient related # of leads Type of leads Type of dilator For each year (5) 1,16/year 0,0001 # of leads, overall (1) NR 0,005 # of leads, incremental (2) 3,51 0,013 ICD vs pacing (2) 2,52 0,053 Ventricular vs atrial? Not isodiametric vs isodiametric? Laser vs mechanical (6) 3 NS Laser vs mechanical (5) 9,14 0,0119 Laser, double coil, superior vena cava (7) +++ NV Gender Female vs male (1) NR 0,01 Female vs male (4) 1,37 NS Concomitant disease Renal failure, creatinine > 2.5 (4) 2,5 0,0164 Infection, endocarditis WBC count increased at time of procedure (2) 1,52 0,005 Endocarditis (4) 4,0 0,001 Endocarditis+diabetes (4) x 1,9 0,0001 Endocarditis+diabetes+ins. Renal failure (4) x 6,3 0,0001

30 Risk score of complications - References 1. Byrd CL, Wilkoff BL, Love CJ, Sellers TD, Turk KT, Reeves R, et al. Intravascular extraction of problematic or infected permanent pacemaker leads: U.S. Extraction Database, MED Institute. Pacing Clin Electrophysiol Sep;22: Agarwal SK, Kamireddy S, Nemec J, Voigt A, Saba S. Predictors of complications of endovascular chronic lead extractions from pacemakers and defibrillators: a singleoperator experience. J Cardiovasc Electrophysiol Feb;20: Byrd CL, Wilkoff BL, Love CJ, Sellers TD, Reiser C. Clinical study of the laser sheath for lead extraction: the total experience in the United States. Pacing Clin Electrophysiol May;25: Wazni O, Epstein LM, Carrillo RG, Love C, Adler SW, Riggio DW, et al. Lead extraction in the contemporary setting: the LExICon study: an observational retrospective study of consecutive laser lead extractions. J Am Coll Cardiol Feb 9;55: Roux JF, Page P, Dubuc M, Thibault B, Guerra PG, Macle L, et al. Laser lead extraction: predictors of success and complications. Pacing Clin Electrophysiol Feb;30: Wilkoff BL, Byrd CL, Love CJ, Hayes DL, Sellers TD, Schaerf R, et al. Pacemaker lead extraction with the excimer laser sheath: results of the Pacing Lead EXtraction with the Excimer Sheath (PLEXES) trial. J Am Coll Cardiol. 1999;33: Hauser RG, Katsiyiannis WT, Gornick CC, Almquist AK, Kallinen LM. Deaths and cardiovascular injuries due to device-assisted implantable cardioverter-defibrillator and pacemaker lead extraction. Europace Mar;12:

31 Factors associated with higher procedure risk Deharo, JC, Bongiorni, M.G, Rozkovec, A, et al.: Pathways for training and accreditation for transvenous lead extraction. Europace 2012; 14:124-34

32 Results Results Success Total Partial Failure Major complications Deaths % References: Wilkoff, Cleveland Clinic Foundation, Cleveland, OH, on behalf of U.S. Database participants, Berlin, XIth Worl Symposyum on Cardiac Pacing and Electrophysiology Byrd CL, US Lead Extraction Database, PACE 1999; 22: Byrd CL, US Laser Lead Extraction Database, PACE 2002; 25: Kennergren, Europace 2001 Byrd CL, NASPE 2001

33 Conclusions The results obtained show that the procedure of lead extraction was rewarded by a high success rate both in terms of a high percentage of success and a limited number of recorded complications, comparable with literature data. The methods employed, involving manual traction with the use of a locking stylet, dilation with the use of polypropylene sheaths and transjugular approach were able to treat and resolve even the most complex cases.

34 Thank you for Your attention! Turin from Villa della Regina: Vittorio Veneto Square, Mole Antonelliana, and the Alps