Search

Objective: To characterize contemporary pacemaker procedure trends., Methods: Nationwide analysis of pacemaker procedures and costs between 2008 and 2017 in Australia. The main outcome measures were total, age- and gender-specific implant, replacement, and complication rates, and costs., Results: Pacemaker implants increased from 12,153 to 17,862. Implantation rates rose from 55.3 to 72.6 per 100,000, a 2.8% annual increase (incidence rate ratio [IRR] 1.028; 95% CI, 1.02-1.04; p < .001). Pacemaker implants in the 80+ age group were 17.37-times higher than the < 50 group (95% CI 16.24-18.59; p < .001), and in males were 1.48-times higher than in females (95% CI 1.42-1.55; p < .001). However, there were similar increases according to age (p = .10) and gender (p = .68) over the study period. Left ventricular lead rates were stable (IRR 0.995; 95% CI 0.98-1.01; p = .53). Generator replacements decreased from 20.5 to 18.3 per 100,000 (IRR 0.975; 95% CI 0.97-0.98; p < .001). Although procedures for generator-related complications were stable (IRR 0.995; 95% CI 0.98-1.01; p = .54), those for lead-related complications decreased (IRR 0.985; 95% CI 0.98-0.99; p < .001). Rates for all pacemaker procedures were consistently greater in males (p < .001). Although annual costs of all pacemaker procedures increased from $178 million to $329 million, inflation-adjusted costs were more stable, rising from $294 million to $329 million., Conclusions: Increasing demand for pacemaker implants is driven by the ageing population and rising rates across all ages, while replacement and complication procedure rates appeared more stable. Males have consistently greater pacemaker procedure rates than females. Our findings have significant clinical and public health implications for healthcare resource planning., (© 2021 Wiley Periodicals LLC.)

Background: Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic stenosis (AS). There is limited data exploring differences in outcomes post-TAVI SEV vs. BEV. This study compared procedural success and 30-d clinical outcomes self-expandable valves (SEV), vs. balloon-expandable valves (BEV) for patients with severe AS. Methods: Retrospective analysis was undertaken of patients receiving TAVI at St Vincent's Hospital, Melbourne between August 2009 and May 2018. The primary endpoints included procedural success, clinical outcomes and complication rates at 30-d. Results: Out of 151 patients undergoing TAVI, 70 received (46.3%) SEV (Medtronic CoreValve & Evolut-R) and 81 (53.6%) BEV (Edwards SAPIEN-XT & S3). The mean Society of Thoracic Surgery (STS) risk score did not differ between the groups, SEV (83.6 ± 4.9 years, STS 4.4 ± 3.8) compared to BEV (82.3 ± 5.8 years, STS 4.9 ± 4.9). Procedural success was similar SEV 67 (95.7%) vs. BEV 78 (96.3%). Rates of ≥ moderate paravalvular aortic regurgitation (PAR) at 30-d were significantly higher in SEV compared to BEV (6.7 vs. 0.0%; p =  .02). SEV patients had higher rates of pacemaker insertion (36.4 vs. 9.5%; p =  .001) and stroke rates (12.4 vs. 1.4%; p =  .04) compared to BEV patients. The difference in 30-d mortality between the two groups was similar (SEV 4.6% vs. BEV 1.3%; p  = .23). Conclusions: This real-world retrospective analysis demonstrates higher rates of ≥ moderate PAR, stroke and pacemaker insertion with SEV compared to BEV at 30 d post-TAVI for severe symptomatic AS.

Objective: Patients undergoing single-ventricle palliation have experienced significant improvement in survival in the recent era. However, a substantial proportion of these patients undergo reoperations. We performed a review of the Australia and New Zealand (ANZ) Fontan Registry to determine the overall reintervention and reoperative burden in these patients., Methods: A retrospective longitudinal cohort study was performed using data from patients who underwent a Fontan operation between 1975 and 2016 from the ANZ Fontan Registry. The data obtained included Fontan operation, reinterventions and most recent follow-up status. We examined the type and timing of reinterventions and survival., Results: Of the 1428 patients identified, 435 (30%) underwent at least one reintervention after the Fontan operation: 110 patients underwent early reintervention and 413 underwent late reinterventions. Excluding Fontan conversion and transplantation, 220 patients underwent at least one interventional procedure and 209 patients underwent at least one reoperation. Fenestration closure and pacemaker-related procedures were the most common catheter and surgical interventions, respectively. The cumulative incidence of reintervention following Fontan was 23%, 37% and 55% at 10, 20 and 30 years, respectively. Survival and freedom from failure were worse in patients requiring later reintervention after Fontan surgery (51% vs 83% and 42% vs 69%, respectively at 30 years, p<0.001). This difference persisted after excluding pacemaker-related procedures (p<0.001). Operative mortality for non-pacemaker late reoperations after Fontan was 6%., Conclusions: A substantial proportion of Fontan patients require further intervention to maintain effective single-ventricle circulation. Patients undergoing reoperation after Fontan have higher rates of mortality and failure, despite intervention., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: A pacemaker (PM) and implantable cardioverter-defibrillator (ICD) survey was undertaken in Australia (Au) and New Zealand (NZ) for 2005., Results and Conclusions: Compared to the 2001 survey, significant increases in implantation numbers were recorded. For 2005, the total new PMs implanted was 11,850 in Au (9498 in 2001) and 1134 in NZ (914 in 2001). The number of new PM implants per million population was 590 in Au (486 in 2001) and 275 in NZ (245 in 2001). Biventricular PMs were documented for the first time with 461 implants in Au and 16 in NZ. Pulse generator types were predominantly dual chamber with 73% in Au (70% in 2001) and 51% in NZ (54% in 2001). Pacing leads were overwhelmingly transvenous and bipolar with an increase in the use of active fixation leads in preference to tined leads. There was a marked increase in the use of ICDs with 2864 new implants in Au (956 in 2001) and 134 in NZ (86 in 2001). The new ICD implants per million population were 142 in Au (49 in 2001) and 33 in NZ (23 in 2001). ICDs were 35% biventricular in Au and 10% in NZ. The Au Northern Territory is included for the first time.

Background: Despite the increasingly widespread use of active-fixation leads, long-term clinical follow-up of pacing lead outcomes is lacking. The aim was to analyze pacing parameters over a 2-year follow-up. We performed a prospective observational study of consecutive new pacemaker implants using the 1488T St. Jude (100) and the Medtronic 5076 (100) active-fixation leads. Detailed analysis of pacing parameters was collected at implant, day 1, and 1, 3, 6, 12, 18, and 24 months., Methods and Results: One hundred patients underwent implantation of 100 dual-chamber pacemakers. Initial pacing parameters in the ventricle were threshold 0.7 +/- 0.2 V, R wave 12.0 +/- 6.5 mV, and impedance 879 +/- 224 Omega. Threshold increased significantly from day 1 (0.7 +/- 0.2 V) to month 1 (0.9 +/- 0.6 V, P < 0.01) and remained stable over the long term. Four of the 100 patients had a threshold >2 V (mean 3.3 +/- 0.9 V) all between day 1 and month 3. For all patients, R wave remained stable, but impedance declined significantly from day 1 (879 +/- 184 Omega) to month 1 (677 +/- 122 Omega, P < 0.01). There were no ventricular lead complications. Initial pacing parameters in the atrium were threshold 0.9 +/- 0.3 V, P wave 3.3 +/- 2.4 mV, and impedance 606 +/- 144 Omega. Threshold remained stable over the long-term follow-up. One of 100 patients had a rise in threshold >2 V (2.2 V) between day 1 and month 1. No patients underwent lead repositioning. Sensing and impedance remained stable over the long term. Patient follow-up was completed in 94% (6 unrelated deaths). There was an 8% incidence of atrial fibrillation., Conclusion: Active-fixation leads are generally associated with stable long-term pacing parameters.

This paper discusses the problems associated with the refurbishing and re-use of medical devices which are sold by manufacturers as 'single use items' by focusing in particular on the re-use of pacemakers. Re-use of single-use devices such as pacemakers does occur in Australia, and in many other parts of the world, but there has been little public awareness of this fact. The paper explains and discloses medical, legal and ethical issues which arise through the re-use of pacemakers. It also discusses the recommendations of the 1995 'Draft report of the NHMRC Expert Panel on Re-Use of Medical Devices Labelled as Single Use'.