The Carpentier-Edwards supra-annular porcine bioprosthesis was implanted in 1,576 operations (1,536 patients with 1,704 valves) between 1981 and 1987. The mean age of the patients was 61.9 years (range 13 to 87 years). During the years 1981 and 1987, approximately 90% of the total valvular surgery population received the prosthesis. The early mortality was 7.0% (included patients with concomitant procedures including coronary artery bypass and ascending aortic aneurysm resection). Late mortality was 4.0% per patient-year. The total cumulative follow-up was 4,237 years. Thromboembolism (TE) was 2.4% per patient-year (fatal 0.4% per patient-year) (minor 1.2%; major 1.3%); antithromboembolic therapy-related hemorrhage (ATH) 0.5% (fatal 0.07%); prosthetic valve endocarditis (PVE) 0.5% (fatal 0.2%); periprosthetic leak (PPL) 0.3% (fatal 0%); clinical valve dysfunction (CVD) 0.3% (fatal 0.02%); and structural valve deterioration/primary tissue failure (SVD) 0.2%/patient-year (fatal 0%). Thromboembolism and structural valve deterioration were the significant complications, SVD occurring primarily between the fourth and fifth year of evaluation. The overall patient survival was 77.1% +/- 1.4% at five years. The patients were classified as 89.6% NYHA functional Class III and IV preoperatively and 96.1% Class I and II postoperatively. The freedom at five years from TE was 90.6% +/- 1.0%; SVD 98.9% +/- 0.5%; and reoperation 95.9% +/- 0.9%. Freedom from all valve-related complications at five years was 84.1% +/- 1.3%; valve-related mortality 96.8% +/- 0.7%; mortality and reoperation (valve failure) 92.9% +/- 1.1%; mortality and residual morbidity (treatment failure) 93.7% +/- 0.9%; and mortality, residual morbidity, and reoperation (valve failure and dysfunction) 90.0% +/- 1.2%. There were 28 valve-related deaths of a total 280 deaths (early 4, late 24) (TE 17; ATH 3; CVD 1; PVE 7; PPL 0; and SVD 0). Valve-related reoperations were performed in 32 patients (TE 2; CVD 4; PVE 7; PPL 11; and SVD 8). The supra-annular Carpentier-Edwards porcine bioprosthesis has provided very satisfactory clinical performance and afforded patients an excellent quality of life. The long-term durability of this low pressure glutaraldehyde fixed prosthesis will be determined by observation over the next five to seven years.
Studies have shown patients who are delayed for surgical cardiac revascularization are faced with increased risks of symptom deterioration and death. This could explain the observation that operative mortality among persons undergoing coronary artery bypass surgery (CABG) is higher among women than men. However, in jurisdictions that employ priority wait lists to manage access to elective cardiac surgery, there is little information on whether women wait longer than men for CABG. It is therefore difficult to ascertain whether higher operative mortality among women is due to biological differences or to delayed access to elective CABG. Using records from a population-based registry, we compared the wait-list time between women and men in British Columbia (BC) between 1990 and 2000. We compared the number of weeks from registration to surgery for equal proportions of women and men, after adjusting for priority, comorbidity and age. In BC in the 1990s, 9,167 patients aged 40 years and over were registered on wait lists for CABG and spent a total of 136,071 person-weeks waiting. At the time of registration for CABG, women were more likely to have a comorbid condition than men. We found little evidence to suggest that women waited longer than men for CABG after registration, after adjusting for comorbidity and age, either overall or within three priority groups. Our findings support the hypothesis that higher operative mortality during elective CABG operations observed among women is not due to longer delays for the procedure.
Many health care systems now use priority wait lists for scheduling elective coronary artery bypass grafting (CABG) surgery, but there have not yet been any direct estimates of reductions in in-hospital mortality rate afforded by ensuring that the operation is performed within recommended time periods. We used a population-based registry to identify patients with established coronary artery disease who underwent isolated CABG in British Columbia, Canada. We studied whether postoperative survival during hospital admission for CABG differed significantly among patients who waited for surgery longer than the recommended time, 6 weeks for patients needing semi-urgent surgery and 12 weeks for those needing non-urgent surgery. Among 7316 patients who underwent CABG, 97 died during the same hospital admission, for a province-wide death rate at discharge of 1.3%. The observed proportion of patients who died during the same admission was 1.0% (27 deaths among 2675 patients) for patients treated within the recommended time and 1.5% (70 among 4641) for whom CABG was delayed. After adjustment for age, sex, anatomy, comorbidity, calendar period, hospital, and mode of admission, patients with early CABG were only 2/3 as likely as those for whom CABG was delayed to experience in-hospital death (odds ratio 0.61; 95% confidence interval [CI] 0.39 to 0.96). There was a linear trend of 5% increase in the odds of in-hospital death for every additional month of delay before surgery, adjusted OR = 1.05 (95% CI 1.00 to 1.11). We found a significant survival benefit from performing surgical revascularization within the time deemed acceptable to consultant surgeons for patients requiring the treatment on a semi-urgent or non-urgent basis.
The Canadian trial of physiologic pacing (CTOPP), published in 2000, demonstrated a reduction in atrial fibrillation (AF), stroke and death with preservation of atrioventricular synchrony, though only the lower rate of AF was statistically significant. The purpose of this study was to determine the effect of CTOPP on pacing mode selection in our region. The British Columbia Cardiac Registry contains prospectively entered data covering a population of 4 millions (M) and 17 implanting centers. It was examined for mode selection trends from 1997 to 2002. At examination, there were data on 22,446 pulse generators (PG) and 29,898 leads. New implant rates per M population were 1997:473; 1998:456; 1999:505; 2000:513; 2001:486; 2002:510. PG replacements also increased, resulting in a total implant rate of 667 PG per M in 2002. Over the 6‐year period, DDD use decreased from 321 to 306, but DDDR use, more than doubled from 317 to 750 PG/year. VVI use steadily decreased from 741 to 410 PG/year, while VVIR use increased more modestly from 1997 to 1999, then remained stable. During the 6‐year period bracketing CTOPP, use of modes maintaining AV synchrony increased by over 32%, to 53% of PG implanted in 2002. Our PG implant rate was much higher than expected from prior retrospective surveys, and similar to rates in Belgium, France, and Germany. CTOPP did not decrease our use of physiologic pacing but, instead, was associated with a brief pause, then progressively increased in both academic and community centers. Patients' need and widely accepted standards of care proved more important in clinical decision making than the results of a flawed randomized trial.
Objective: Advancing life expectancy with the increased prevalence of aortic valve degenerative disease brings the need for an aortic bioprosthesis with excellent haemodynamic performance and comparable durability. The Mitroflow bioprosthesis has been on the worldwide market, except in the United States, since 1982, while the current model (1991) has only recently gained regulatory approval in the latter country. This study was primarily performed to determine the durability of the current Mitroflow bioprosthesis. Methods: The contemporary Mitroflow bioprosthesis was implanted in 381 patients in three centres. The mean age was 76.4 years (range 53–91 years) and the mean follow-up period was 5.4 ± 3.4 years, a total of 2048.7 years of evaluation. Prosthesis–patient mismatch (PPM) was classified by reference effective orifice area index categories: normal ≥0.85 cm2 m−2 (53.9%), mild 0.84–0.76 cm2 m−2 (33.9%), moderate ≤0.75–0.66 cm2 m−2 (11.7%) and severe ≤0.65 cm2 m−2 (0.5%). Results: The survival, at 10 years, was 39.9 ± 7.9% for 50–69 years, 27.0 ± 3.7% for 70–79 years and 16.6 ± 4.4% for ≥80 years (p = 0.011). There was a trend (p = 0.063) influencing survival for moderate-to-severe PPM. Of the independent predictors influencing survival – moderate-to-severe projected effective orifice area index (pEOAI) (Hazard Ratio (HR) 1.6, p = 0.0142) and left ventricular dysfunction (ejection fraction ≪35%) (HR 1.9, p = 0.0193) were included. The 10-year freedom from structural valve deterioration (SVD) at explant assessing the same age groups as survival was not different (p = 0.081). The 10-year actual/actuarial freedom from SVD, at explant was for ≥60 years – 94.4 ± 1.4% (85.2 ± 3.9%), for ≥65 years – 94.2 ± 1.4% (85.0 ± 4.0%), for 61–70 years – 97.4 ± 2.6% (95.7 ± 4.3%) and for >70 years – 94.0 ± 1.5% (83.2 ± 4.6%). Conclusions: The Mitroflow external mounted, pericardial aortic bioprosthesis with documented excellent haemodynamics (especially for the small aortic root), demonstrates that prosthesis–patient mismatch in moderate and severe categories can essentially be eliminated, with durability performance comparable to other heterograft (porcine and pericardial) bioprostheses.
Priority wait lists are common for managing access to cardiac surgery in publicly funded health systems. We evaluated whether longer delays contribute to the probability of death before surgery among patients prioritized into the less urgent category.We studied records of 9233 patients registered for isolated coronary artery bypass graft (CABG) in British Columbia, Canada. The primary outcome was death before surgery. We estimated the probability that a patient, who could be removed from the list as a result of surgery, death, or other competing events, dies on or before a certain wait-list week.Despite similar death rates in semiurgent and nonurgent groups, 0.63 (95% confidence interval, 0.46-0.80) versus 0.58 (0.36-0.80) per 1000 patient-weeks, nonurgent patients were remaining on the list longer, which contributed to higher cumulative incidence of all-cause death than in semiurgent group (adjusted odds ratio = 1.66; 1.03-2.68). By 52 weeks on the wait list, 0.9% (0.6-1.1) and 1.3% (0.8-1.8) of patients died in semiurgent and nonurgent groups, respectively (P < 0.01). Similar proportions of deaths related to cardiovascular disease estimated over wait-list time in both groups (P = 0.40) were the result of shorter delays in the semiurgent group despite a higher rate of death resulting from cardiovascular disease (0.50 [0.36-0.65] vs. 0.34 [0.17-0.51] per 1000 patient-weeks).Queuing according to urgency of treatment contributed to a higher proportion of CABG candidates dying before surgery from all causes in the nonurgent compared with the semiurgent group despite similar weekly death rates observed in both groups. However, similar probabilities of death resulting from cardiovascular disease observed in both groups over wait-list time were the result of shorter delays in the semiurgent group despite a higher rate of cardiovascular death.
In British Columbia, Canada, all necessary medical services are funded publicly. Concerned with growing wait lists in the mid-1990s, the provincial government started providing extra funding for coronary artery bypass grafting (CABG) operations annually. Although aimed at improving access, it is not known whether supplementary funding changed the time that patients spent on wait lists for CABG. We sought to determine whether the period of registration on wait lists had an effect on time to isolated CABG and whether the period effect was similar across priority groups.Using records from a population-based registry, we studied the wait-list time before and after supplementary funding became available. We compared the number of weeks from registration to surgery for equal proportions of patients in synthetic cohorts defined by five registration periods in the 1990s.Overall, 9,231 patients spent a total of 137,126 person-weeks on the wait lists. The time to surgery increased by the middle of the decade, and decreased toward the end of the decade. Relative to the 1991-92 registration period, the conditional weekly probabilities of undergoing surgery were 30% lower among patients registered on the wait lists in 1995-96, hazard ratio (HR) = 0.70 (0.65-0.76), and 23% lower in 1997-98 patients, HR = 0.77 (0.71-0.83), while there were no differences with 1999-2000 patients, HR = 0.94 (0.88-1.02), after adjusting for priority group at registration, comorbidity, age and sex. We found that the effect of registration period was different across priority groups.Our results provide evidence that time to CABG shortened after supplementary funding was provided on an annual basis to tertiary care hospitals within a single publicly funded health system. One plausible explanation is that these hospitals had capacity to increase the number of operations. At the same time, the effect was not uniform across priority groups indicating that changes in clinical practice should be considered when adding extra funding to reduce wait lists.
Currently there are no direct estimates of mortality reduction afforded by coronary-artery bypass grafting (CABG) that take into account the deaths among patients for whom coronary revascularization was indicated but who did not undergo the treatment. The objective of this analysis was to compare survival after the treatment decision between patients who underwent CABG and those who remained untreated. We used a population-based registry to identify patients with established coronary artery disease who were to undergo first-time isolated CABG. We measured the effect of surgical revascularization on survival after the treatment decision in two cohorts of patients categorized by symptoms, coronary anatomy, and left ventricular function. One in 10 patients died during the five years after treatment decision. The hazard of death among patients who underwent CABG was 51 percent of that for the untreated group, the adjusted hazard ratio was 0.51 (95 percent confidence interval, 0.43 to 0.61). The effect was stronger when CABG was performed within the recommended time: adjusted hazard ratios were 0.43 (95 percent confidence interval, 0.35 to 0.53) and 0.58 (95 percent confidence interval, 0.48 to 0.70) for early and late intervention, respectively; chi-square for the difference between hazard ratios was 12.2 (P < 0.001). Estimates that account for patients who died before they could undergo a required CABG indicate a significant survival benefit of performing early surgical revascularization even for patients registered to undergo the operation on the non-urgent basis.
