HHE Cardiovascular supplement 2018 - Page 14

Electrical parameters at the time of implantation and at six months closely approximated those seen in the investigational study. 12 Real-world data from a worldwide registry corroborate the findings of the investigational study. Of 795 patients who underwent an attempted implantation, the Micra™ was successfully implanted in 792 (99.6%). The 30-day major complication rate was low at 1.51%, including six (0.75%) puncture site complications, one (0.13%) cardiac perforation with effusion requiring pericardiocentesis, and one (0.13%) device dislodgement without embolisation. One patient, a 96-year-old man with severe aortic valve disease, died from pulmonary oedema the day after the procedure. The device was functioning normally at the time, had not migrated and there was no evidence of pericardial tamponade. 12 There were four (0.50%) other cardiac perforation events that fell outside the criteria for a major complication, because they did not result in death, system revision or prolonged hospitalisation. In three cases no action was required, and in one pericardiocentesis was undertaken. Figure 4 Chest X rays (A) showing a standard single chamber permanent pacemaker with septal position ventricular lead, and (B) a Nanostim™ LCP positioned at the right ventricular apex. Used with permission of Mayo Foundation for Medical Education and Research, all rights reserved. 14 HHE 2018 | hospitalhealthcare.com Nanostim™ Leadless Cardiac Pacemaker (LCP) At 42mm in length, the Nanostim™ LCP is longer than the Micra™, but with a smaller diameter at 5.99mm requires a smaller introducer sheath at implantation. The principles of the implantation procedure are broadly the same as with the Micra™, with the most notable difference being that the Nanostim™ is affixed to the myocardium by means of a screw-in helix at its tip. Figure 4 shows two chest X rays with a transvenous single chamber pacemaker and the Nanostim™ respectively. The LEADLESS trial, the first study to assess safety and efficacy of the Nanostim™, was a small single-arm, multi-centre study involving 33 patients. Successful device implantation occurred in 32 (97%) patients, and 31 (94%) remained free from complications at 90 days. Of the remaining two patients, one had a patent foramen ovale through which the Nanostim™ had inadvertently been passed before implantation in the left ventricle. This was subsequently recognised and the device successfully retrieved. The other patient sustained cardiac perforation and tamponade at implantation, requiring pericardial drainage and later median sternotomy and surgical repair of the apical perforation. He later suffered a st H[X\]Y[HYY L•H]X\\PQTRHX[[YY[[\\و L]Y[وHX\ٝ[[\[][ۈ\Y[ L  MK JKH]HقYYHH\X][ۜ\^[۝œ Z[\[][ۈ\LˌK\H\H ]XH[]Y\X][ۜ[ ]Y[ JK[Y[]XH\[Y[ KJK\XXœ\ܘ][ۈ KJK\[\\X][ۜ KJB[Y\\H\\]Z\[]XB]Y][[Z[\[][ۈ KJK]XBZYܘ][ۈ\Y[^]Y[Z]\B[[ܘ[Z[܈[[ۘ\H\\K[[[\\H]XH\X\ٝ[H]Y]Y\][[\K\H\HX] JBYYYHY\K\[]Y []X[[\[XX[\[Y]\\HYZ[[H\H[\\\ܝ []H[[H\[\ݙ[Y[ݙ\[YBYHXH K M\]HHZ\[Y[[YHYYX[[\[H[Y\\[\[][ۜوB[[x([ؙ\ MYH\ܝق[X]\H]\HZ[\HXY[X[›]] \H\H XZ[\\\ܝY ]و M [[x([\[][ۜܛYB JK\H\Y]HYX[و H0H YX\˜Y\[\[][ۋ\H\H\ܝو[B]Y[][YH\H\H\[ MB\H]Y][وH]XH\][\Y ]\X\ٝ[[L Hو\\ˈ[H[XZ[[ŽKKH[]ۈݙY[X\XK[[ۙH\HX[YH]XY[ZYܘ]YB[[ۘ\H\\KH[و LMH]Y[\B][[Y][ۘ[X[XZ\]][][\]]Y][H[[x([\B\H\ܝوY\H[\X[ۜœX\]Y[H]Y[H^\[\[\ˈ M