( 41.3 %) or cardiac resynchronation therapy with a defibrillator ( CRT- D ) ( 38.9 %) and 95,545 ( 83.5 %) of these devices were used for primary prevention .
The median duration of followup after implantation was 2.7 years . During this period , 40,072 ( 35 %) patients died , and the cumulative incidence of mortality increased linearly over time , reaching 55 % by 6 years follow-up . Mortality was higher among patients who received ICDs for secondary , rather than primary , prevention and among those who received CRT-D rather than single- or dual-chamber devices .
Isuru Ranasinghe , MBChB , MMed , PhD , and colleagues observed 6.1 ICD-related complications per 100 patient-years of follow-up . Of these , reoperation was necessary in 2.6 per 100 patient-years , mostly due to device malfunction or infection . Additionally , 3.5 patients per 100 patient-years had a complication that required hospitalization only , with a greater number of mechanical complications than device infections . The highest rates of ICD-related complications were seen in the first 90 days after implantation . More complications were seen in patients with CRT- D and those implanted for secondary prevention .
The authors write that this study “ makes novel observations about the association between patient factors and risk for long-term complications .” Patients who were younger at implantation , female and black , had the strongest independent associations with increased hazards for device complications , as did increasing complexity of ICD devices . Older age and the presence of comorbidities such as diabetes , prior myocardial infarction and poor left ventricular function were associated with a lower adjusted hazard for complications . According to the researchers , this is primarily due to a higher observed morality leading to reduced survival time , and therefore , exposure to complications .
“ Long-term risks of ICD implantation and strategies to reduce them , such as by device selection , should be actively considered in the preimplantation decision-making process ,” the authors conclude .
Ranasinghe I , Parzynski CS , Freeman JV , et al . Ann Intern Med . 2016 ; doi : 10.7326 / M15- 2732
PCI Access Site and Outcomes : Are Operator and Center Volume a Factor ?
In percutaneous coronary intervention ( PCI ), transradial access is associated with reduced access site-related bleeding complications and mortality . According to research published in Circulation : Cardiovascular Intervention , this may be due to both the total procedural volume and the proportion of procedures undertaken radially by operator . Operators undertaking the greatest proportion of their procedures radially demonstrated the largest relative reduction in mortality risk .
While radial access is more difficult to master than femoral , it has become the preferred access site in many countries .
In this analysis from the British Cardiovascular Intervention Society , William Hulme , MSc , and colleagues , a total of 164,395 PCI procedures performed in patients in England and Wales between 2012 and 2013 were analyzed . The influence of operator and center total volume , radial volume , and radial proportions on outcomes was studied . Operators typically performed either high proportion of radial or femoral procedures , with few performing around 50 % of each . High-volume centers were more likely to be highproportional radial centers . During the study period , radial proportion increased from 60.4 %– 70.1 %.
The use of transradial access increased from 54.3 % in the lowest operator total volume group to 72.9 % in the highest total volume group , and increased from 57.6 % in the lowest center total volume group to 76.0 % in the highest center total volume group . Across all operator and center volume groups , crude 30-day mortality outcomes were significantly fewer in the transradial cohort . The authors report similar observations for in-hospital major adverse cardiac events and major bleeding complications .
Hulme and colleagues also report that the study suggests that higher total volume of procedures and higher proportion of cases undertaken radially at the operator level are independently associated with a larger reduced odds of mortality , with an 11 % reduction in the odds for 30-day mortality for each 100 extra procedures performed per year , and an 8 % reduction in the odds for 30-day mortality for each 10 % increase in the proportion of cases undertaken through the transradial approach compared to the transfemoral approach .
The authors had previously found that the greatest mortality reduction associated with transradial approach
Patients at low risk of bleeding complications gain little mortality benefit from adopting this approach .
adoption is derived from patients at highest baseline bleeding risk , who are often the most hemodynamically unstable , have adverse clinical characteristics such as the elderly , women , or are undergoing PCI for emergent indications , whereas patients at low risk of bleeding complications gain little mortality benefit from adopting this approach . ■
Hulme W , Sperrin M , Rushton H , et al . Circ Cardiovasc Interv . 2016 ; 9 : e003333 .
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