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1.
Clin Pharmacol Drug Dev ; 12(1): 57-64, 2023 01.
Article in English | MEDLINE | ID: mdl-36168148

ABSTRACT

Dysphagia is highly prevalent in patients with amyotrophic lateral sclerosis (ALS). Riluzole is a US Food and Drug Administration-approved treatment for ALS. Riluzole oral film (ROF; Exservan™) contains riluzole in a polymer-based film matrix. The ROF is administered by placing on the tongue, where it dissolves and the drug is ingested with the saliva. Two clinical trials assessed the safety and tolerability of the ROF. Bioavailability and pharmacokinetics (PK) were evaluated in an open-label, randomized, single-dose, replicate crossover study of 50 mg of ROF and riluzole 50-mg tablets in 32 healthy volunteers. The second study was a videofluoroscopic swallowing examination conducted with nine patients with ALS before and after receiving a single dose of 50 mg of ROF. The primary outcome was change on penetration-aspiration scale (PAS) scores from pre- to post-dose. Overall, the PK parameters for ROF and riluzole tablets were comparable between treatments and administrations when administered under fasting conditions. Administration of ROF with food resulted in a 15% reduction in area under the curve and a 45% reduction in maximum serum concentration. A total of 44 treatment-emergent adverse events (AEs) were reported in the study; all were mild in severity. No serious AEs were observed and no subjects discontinued due to AEs. In the swallowing study, very little numerical or categorical change was observed following the dose of ROF. No evidence of deterioration of swallowing function was observed post-dose. The ROF was bioequivalent to riluzole tablets, was well tolerated, and had no detrimental effect on swallowing.


Subject(s)
Amyotrophic Lateral Sclerosis , Riluzole , United States , Humans , Riluzole/adverse effects , Amyotrophic Lateral Sclerosis/drug therapy , Amyotrophic Lateral Sclerosis/chemically induced , Biological Availability , Deglutition , Cross-Over Studies
2.
J Card Surg ; 37(4): 927-929, 2022 Apr.
Article in English | MEDLINE | ID: mdl-35083788

ABSTRACT

External reinforcement of the dilated or thin-walled aorta has been tried for nearly half a century. A range of materials has been used as external support. This commentary assesses the evidence that exists regarding the efficacy of wrapping the aorta as well as compares the different options available with a particular focus on the usage of the autologous pericardium.


Subject(s)
Aorta , Aorta/diagnostic imaging , Aorta/surgery , Dilatation, Pathologic , Humans , Retrospective Studies , Treatment Outcome
3.
J Card Surg ; 36(7): 2269-2276, 2021 Jul.
Article in English | MEDLINE | ID: mdl-33821500

ABSTRACT

BACKGROUND: To investigate the impact of severe patient-prosthesis mismatch (PPM) related to the Edwards Lifesciences Perimount (EP) bioprosthesis in the aortic position on early in-hospital outcomes and long-term survival. METHODS: A total of 5964 consecutive patients underwent aortic valve replacement at the Bristol Heart Institute between 1998 and 2014, 2667 representing the cohort of this study received EP. PPM was defined severe as EOAi < 0.65 cm2 /m2 . To minimize bias, propensity score matching was conducted and two groups A and B (without and with severe PPM) of 320 patients with similar preoperative characteristics were matched. We assessed early in-hospital outcomes including CVA, re-exploration for bleeding, low cardiac output, wound infection, acute renal injury, length of hospital stay, and long-term survival for both groups in unmatched and matched populations. RESULTS: In the unmatched analysis, 18.3% of patients had severe PPM. Severe PPM was not associated with increased in-hospital mortality (4.5% vs. 2.9%, respectively, p = .09) or any other early adverse outcomes except increased length of hospital stay (10.57 ± 8.2 vs. 11.7 ± 9.4, respectively, p = .01). Long-term survival differed significantly between groups at 2 and 8 years (91.8% vs. 91.4% and 60.5% vs. 55.7%, respectively, p = .02). Matched analysis showed no differences between the groups in early health outcomes and overall survival at 2 and 8 years was also similar (89.7% vs. 91% and 57.3% vs. 58%, group A vs. B, respectively p = .9). CONCLUSION: Presence of PPM does not seem to affect early in-hospital outcomes or late survival when using EP in patients undergoing aortic valve replacement.


Subject(s)
Aortic Valve Stenosis , Bioprosthesis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Aortic Valve/surgery , Aortic Valve Stenosis/surgery , Humans , Propensity Score , Prosthesis Design , Retrospective Studies , Treatment Outcome
4.
Eur J Cardiothorac Surg ; 60(2): 354-360, 2021 07 30.
Article in English | MEDLINE | ID: mdl-33585898

ABSTRACT

OBJECTIVES: Surgical myocardial revascularization will be increasingly needed in adult patients with congenital heart disease. We investigated the results of coronary artery bypass grafting (CABG) performed on adults by congenital cardiac surgeons at our institution. METHODS: We conducted a retrospective, single-centre study. Adults undergoing isolated or combined CABG from 2004 to 2017 were included. Early and late outcomes were analyzed for the whole cohort. Furthermore, a propensity matched analysis was conducted comparing the results of isolated CABG between congenital and adult surgeons. RESULTS: A total of 514 and 113 patients had isolated and combined CABG for acquired heart disease, respectively. A total of 33 patients had myocardial revascularization at the time of surgery for congenital heart disease. Overall early mortality was 1.2%, the rate of re-exploration for bleeding was 4.5%, and an internal mammary artery to left anterior descending artery graft was used in 85.6% patients. One-year survival was 97.5% (96.2-98.8%), and 5-year survival was 88.0% (84.8-91.3%). After propensity matching (468 pairs), early mortality (0.6% vs 1.2%, P = 0.51), re-exploration for bleeding (3.6% vs 3.0%, P = 0.72), use of internal mammary artery to left anterior descending artery graft (92.7% vs 91.9%, P = 0.70) and late survival did not differ between congenital surgeons and adult surgeons, respectively. CONCLUSIONS: Surgical myocardial revascularization can be required for adult congenital patients in a broad spectrum of clinical situations. Despite lower volumes, congenital cardiac surgeons perform CABG safely and with results that are comparable to those of the adult surgeons at our centre.


Subject(s)
Coronary Artery Disease , Surgeons , Adult , Coronary Artery Bypass , Humans , Propensity Score , Retrospective Studies , Treatment Outcome
5.
Lancet Reg Health Eur ; 1: 100003, 2021 Feb.
Article in English | MEDLINE | ID: mdl-35104303

ABSTRACT

BACKGROUND: There is little known about how payer status impacts clinical outcomes in a universal single-payer system such as the UK National Health Service (NHS). The aim of this study was to evaluate the relationship between payer status (private or public) and clinical outcomes following cardiac surgery from NHS providers in England. METHODS: The National Adult Cardiac Surgery Audit (NACSA) registry was interrogated for patients who underwent adult cardiac surgery in England from 2009 to 2018. Information on socioeconomic status were provided by linkage with the Iteration of the English Indices of Deprivation (IoD). The primary outcome was in-hospital mortality. Secondary outcomes included incidence of in-hospital postoperative cerebrovascular accident (CVA), renal dialysis, sternal wound infection, and re-exploration. To assess whether payer status was an independent predictor of in-hospital mortality, binomial generalized linear mixed models (GLMM) were fitted along with 17 items forming the EuroSCORE and the IoD domains. FINDINGS: The final sample consisted of 280,209 patients who underwent surgery in 31 NHS hospitals in England from 2009 to 2018. Of them, 5,967 (2.1%) and 274,242 (97.9%) were private and NHS payers respectively. Private payer status was associated with a lower risk of in-hospital mortality (OR 0.79; 95%CI 0.65 - 0.97;P = 0.026), CVA (OR 0.77; 95%CI 0.60 - 0.99; P = 0.039), need for re-exploration (OR 0.84; 95%CI 0.72 - 0.97; P = 0.017) and with non-significant lower risk of dialysis (OR 0.84; 95%CI 0.69 - 1.02; P = 0.074). Private payer status was found to be independently associated with lower risk of in-hospital mortality in the elective subgroup (OR 0.76; 95%CI 0.61 - 0.96; P = 0.020) but not in the non-elective subgroup (OR 1.01; 95%CI 0.64 - 1.58; P = 0.976). INTERPRETATION: In conclusion, using a national database, we have found evidence of significant beneficial effect of payer status on hospital outcomes following cardiac surgery in favour of private payers regardless their socioeconomic factors.

6.
J Card Surg ; 36(1): 203-205, 2021 Jan.
Article in English | MEDLINE | ID: mdl-33169876

ABSTRACT

"Turn-down" rate has been reported to have a significant influence on outcomes, and being turned down for an operation is associated with significant short-term mortality risk. A study examining the impact of the pandemic on the "turn-down" rates of acute aortic syndromes in the United Kingdom reported an overall "turn-down" rate of  7.3% in the early part of the pandemic. This review examines the significance of "turn-downs" in this setting and scrutinizes the adequacy of reporting this complex variable.


Subject(s)
Aorta , Emergencies , Humans , Uncertainty , United Kingdom
7.
Indian J Thorac Cardiovasc Surg ; 36(2): 114-118, 2020 Mar.
Article in English | MEDLINE | ID: mdl-33061109

ABSTRACT

BACKGROUND: Out-of-hours work is believed to lead to a higher complication rate and mortality after surgery. However, there is no data supporting this perception in type A acute aortic dissections (TAAD) repair. We present an observational study of prospectively collected data comparing operative outcomes and late survival of TAAD repair performed after hours versus regular daytime working hours. METHODS: A total of 196 patients undergoing emergency TAAD repair (mean age 59 ± 13 years, range 18-81, F/M 57/139) were included in the final analysis. Patients were stratified as daytime between 7 AM and 7 PM (n = 124), and night time between 7 PM and 7 AM (n = 72). Inverse propensity score (PS) weighting for modelling causal effects was used to assess the effect of time procedure on outcomes of interest. RESULTS: Overall 30-day mortality was 14.3% (28 patients). No significant differences were found between the night-time and day-time groups with regard to operative mortality (8.3% versus 17.3%; adjusted OR 0.35; 95%CI 0.12-1.04; P = 0.06), re-exploration (12.5% versus 9.7%; adjusted OR 2.09; 95%CI 0.72-6.07; P = 0.18) and neurological deficit (18.1% versus 16.9%; adjusted OR 0.91; 95%CI 0.33-2.54; P = 0.87). Long-term survival at mean 9 years follow-up was comparable between the two groups (adjusted log-rank P = 0.28). CONCLUSIONS: Night-time surgical repair of TAAD when compared with day-time repair does not seem to be associated with a greater risk of surgical complications, operative mortality and long-term mortality.

8.
J Cardiothorac Vasc Anesth ; 32(1): 170-177, 2018 02.
Article in English | MEDLINE | ID: mdl-29217251

ABSTRACT

OBJECTIVE: To determine the effectiveness and safety of aprotinin use in adult patients undergoing thoracic aortic surgery. DESIGN: Single-center, retrospective study. SETTING: All cases performed at a single university hospital. PARTICIPANTS: Between January 2004 and December 2014, 846 adult patients underwent thoracic aortic surgery. Due to missing or duplicated data on primary outcomes, 314 patients were excluded. The final sample of 532 patients underwent surgery on the thoracic aorta. INTERVENTIONS: The patients were divided in the following 2 groups: 107 patients (20.1%) received aprotinin during the surgery, which represented the study group, whereas the remaining 425 patients (79.9%) underwent surgery without the use of aprotinin. MEASUREMENTS AND MAIN RESULTS: To adjust for patient selection and preoperative characteristics, a propensity score-matched analysis was conducted. Mean total blood loss at 12 hours after surgery was similar between the 2 groups. The blood product transfusion rates did not differ in the 2 groups, except for the rate of fresh frozen plasma transfusion being significantly higher in the aprotinin group. Re-exploration for bleeding and the incidence of a major postoperative bleeding event were similar between the groups. Rates of in-hospital mortality, renal failure, and cerebrovascular accidents did not show any statistically significant difference. Aprotinin did not represent a risk factor for mortality over the long term (hazard ratio 1.14, 95% confidence interval 0.62-2.08, p = 0.66). CONCLUSIONS: The use of aprotinin demonstrated a limited effect in reducing postoperative bleeding and prevention of major bleeding events. Aprotinin did not adversely affect early outcomes and long-term survival.


Subject(s)
Aorta, Thoracic/surgery , Aprotinin/therapeutic use , Cardiac Surgical Procedures/adverse effects , Hemostatics/therapeutic use , Postoperative Hemorrhage/drug therapy , Aged , Aged, 80 and over , Cardiac Surgical Procedures/mortality , Cardiac Surgical Procedures/trends , Cohort Studies , Female , Hospital Mortality/trends , Humans , Male , Middle Aged , Postoperative Hemorrhage/etiology , Postoperative Hemorrhage/mortality , Prospective Studies , Retrospective Studies , Treatment Outcome
9.
Semin Thorac Cardiovasc Surg ; 29(3): 301-310, 2017.
Article in English | MEDLINE | ID: mdl-29195572

ABSTRACT

Despite the widespread use of carbon dioxide insufflation (CDI) in cardiac surgery, there is still paucity of evidence to prove its benefit in terms of neurologic protection. Therefore, we conducted a meta-analysis of available randomized controlled trials comparing CDI vs standard de-airing maneuvers. Electronic searches were performed to identify relevant randomized controlled trials. Primary outcomes investigated were postoperative stroke, neurocognitive deterioration, and in-hospital mortality. Risk difference (RD) was used as summary statistic. Pooled estimates were obtained by means of random-effects model to account for possible clinical diversity and methodological variation between studies. Eight studies were identified with 668 patients randomized to CDI (n = 332) vs standard de-airing maneuvers (n = 336). In-hospital mortality was 2.1% vs 3.0% in the CDI and control group, respectively (RD 0%; 95% confidence interval [CI] -2% to 2%; P = 0.87; I2 = 0%). Incidence of stroke was similar between the 2 groups (1.0% vs 1.2% in the CDI and control group, respectively; RD 0%; 95% CI -1% to 2%; P = 0.62; I2 = 0%). Neurocognitive deterioration rate was 12% vs 21% in the CDI and control group, respectively, but this difference was not statistically significant (RD: -7%; 95% CI -0.22% to 8%; P = 0.35; I2 = 0%). The present meta-analysis did not find any significant protective effect from the use of CDI when compared with manual de-airing maneuvers in terms of clinical outcomes, including postoperative neurocognitive decline.


Subject(s)
Carbon Dioxide/administration & dosage , Cardiac Surgical Procedures/adverse effects , Central Nervous System/drug effects , Cognition/drug effects , Insufflation/methods , Neurocognitive Disorders/prevention & control , Carbon Dioxide/adverse effects , Cardiac Surgical Procedures/mortality , Central Nervous System/physiopathology , Chi-Square Distribution , Hospital Mortality , Humans , Insufflation/adverse effects , Insufflation/mortality , Neurocognitive Disorders/mortality , Neurocognitive Disorders/physiopathology , Neurocognitive Disorders/psychology , Odds Ratio , Randomized Controlled Trials as Topic , Risk Factors , Time Factors , Treatment Outcome
10.
J Thorac Cardiovasc Surg ; 154(4): 1269-1275.e5, 2017 10.
Article in English | MEDLINE | ID: mdl-28669437

ABSTRACT

OBJECTIVES: Although the use of the right internal thoracic artery (RITA) as second arterial conduit to graft the left coronary system consistently has been shown to provide a survival benefit compared with the saphenous vein graft (SVG), the choice of conduit for the right coronary artery (RCA) system remains controversial. We compared long-term (>15 years) survival in patients who underwent RITA-RCA versus SVG-RCA grafting at a single institution. METHODS: The study population consisted of 7223 patients undergoing coronary artery bypass graft surgery. Of them 245 (3.4%) and 6978 (96.6%) received RITA-RCA and SVG-RCA graft, respectively. Propensity score matching and time-segmented Cox regression were used to compare the 2 groups. RESULTS: Survival probability at 5, 10, and 15 years were 95.9% (95% confidence interval [CI], 93.4-98.4) versus 96.0% (95% CI, 94.3-97.8), 89.8% (95% CI, 85.9-93.7) versus 88.0% (95% CI, 85.0-91.0) and 82.9% (95% CI, 77.6-88.2) versus 76.3 (95% CI, 72.0-80.5) in the RITA-RCA and SVG-RCA group, respectively. Time-segmented Cox regression showed that during the first 9 years, the 2 strategies were associated with comparable risk of death (hazard ratio, 1.13; 95% confidence interval, 0.67-1.90; P = .65) but beyond 9 years, the RITA-RCA was associated with a significantly lower risk of death (hazard ratio, 0.43; 95% confidence interval, 0.22-0.84; P = .01). CONCLUSIONS: Revascularization of the RCA system with the RITA was associated with superior late survival compared with SVG. This supports the view that, the use of RITA to graft the RCA should be encouraged, especially in patients with long life expectancy.


Subject(s)
Mammary Arteries , Coronary Vessels , Humans , Propensity Score , Radial Artery , Retrospective Studies , Saphenous Vein , Treatment Outcome
11.
Semin Thorac Cardiovasc Surg ; 29(1): 12-22, 2017.
Article in English | MEDLINE | ID: mdl-28683990

ABSTRACT

The learning curve of coronary artery bypass grafting (CABG) with multiple arterial grafting (MAG) is perceived to be associated with increased surgical morbidity and potentially poorer long-term outcomes. We compared short-term outcomes and long-term survival in patients who underwent CABG with MAG performed by attending surgeons or resident trainees at a single institution over a period of 19 years. Using our institutional database, we identified 3039 patients undergoing MAG from 1996-2015. Of those, 958 (32%) were operated on by residents and 2081 (68%) by attending surgeons. Propensity score matching and mixed-effects models were used to compare the 2 groups. Operative mortality rate was 0.3% and 0.4% among patients operated by residents and attending surgeons, respectively (P = 0.71), with no significant differences among the groups in postoperative complications. After a mean follow-up time of 11 ± 4 years, survival probability at 5, 10, and 15 years was 95.1% ± 0.7% vs 96.4% ± 0.6%, 87.0% ± 1.1% vs 87.8% ± 1.1%, and 76.6.% ± 1.8% vs 77.6% ± 1.8% in the resident and attending surgeon group, respectively. Resident and attending surgeon cases showed comparable risk of death (hazard ratio [HR] = 1.01; 95% CI: 0.80-1.28; P = 0.92). The equipoise between the 2 groups was confirmed among cases receiving bilateral internal thoracic arteries only (HR = 0.88; 95% CI: 0.54-1.43; P = 0.61), radial artery (HR = 1.22; 95% CI: 0.92-1.61; P = 0.15), or their combination (HR = 0.74; 95% CI: 0.33-1.65; P = 0.47). The present analysis confirms that adequately supervised trainees can perform CABG with MAG without compromising patient safety and long-term survival.


Subject(s)
Coronary Artery Bypass/education , Coronary Artery Disease/surgery , Education, Medical, Graduate , Internship and Residency , Academies and Institutes , Clinical Competence , Coronary Artery Bypass/adverse effects , Coronary Artery Bypass/mortality , Coronary Artery Disease/diagnosis , Coronary Artery Disease/mortality , Curriculum , Databases, Factual , England , Humans , Learning Curve , Logistic Models , Multivariate Analysis , Patient Safety , Postoperative Complications/etiology , Program Evaluation , Propensity Score , Proportional Hazards Models , Registries , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
12.
Br J Hosp Med (Lond) ; 78(6): 320-326, 2017 Jun 02.
Article in English | MEDLINE | ID: mdl-28614024

ABSTRACT

Aortic dissection remains a serious cardiovascular emergency with significant early and late mortality and morbidity. Improving outcomes is directly linked to early clinical diagnosis, swift confirmation by appropriate imaging and management by dedicated teams with high levels of expertise in a complex clinical condition.


Subject(s)
Antihypertensive Agents/therapeutic use , Aortic Aneurysm/therapy , Aortic Dissection/diagnostic imaging , Aortic Dissection/therapy , Pain Management/methods , Vascular Surgical Procedures/methods , Aortic Dissection/complications , Aortic Aneurysm/complications , Aortic Aneurysm/diagnostic imaging , Aortic Rupture/etiology , Early Diagnosis , Early Medical Intervention , Echocardiography , Emergencies , Humans , Magnetic Resonance Imaging , Tomography, X-Ray Computed
13.
Int J Cardiol ; 246: 32-36, 2017 Nov 01.
Article in English | MEDLINE | ID: mdl-28499666

ABSTRACT

BACKGROUND: We sought to compare the incidence of incomplete revascularization (IR) and long-term survival (up to 20years) after off-pump (OPCAB) versus on-pump (ONCAB) coronary artery bypass in a high OPCAB volume centre where OPCAB was introduced in 1996 and has become the preferred strategy over the years. METHODS AND RESULTS: From 1996 to 2015 a total of 7,427 OPCAB and 7128 ONCAB procedures were performed at Bristol Heart Institute, United Kingdom. We obtained 5423 propensity matched pairs for final comparison. Mixed effect Cox model accounting for clustering due to different surgeon was used to investigate the treatment effect on mortality. RESULTS: OPCAB was associated with higher rate of incomplete revascularization 13.3% versus 6.7%; P<0.0001). Mean follow-up time was 7.8±4.6year [max 17.3]. At 12years OPCAB was associated with a marginal but significant +3% increase in overall mortality (67.4%[95%CI 65.8-69.1] vs 64.4%[95%CI 62.7-66.2]; stratified log-rank P=0.03). When compared to ONCAB with complete revascularization, OPCAB with IR (HR 1.74;95%CI 1.53-1.99; P<0.001) and ONCAB with IR (HR 1.29; 95%CI 1.06-1.57; P=0.01) but not OPCAB with complete revascularization (HR 1.02;95%CI 0.94-1.11; P=0.63) were associated with increased risk of late mortality. CONCLUSION: Despite completeness of revascularization was achieved in the majority of OPCAB cases, OPCAB remained associated with a significantly higher rate of incomplete revascularization. This translated into a marginal but significant reduction in late survival rates after OPCAB when compared to ONCAB.


Subject(s)
Coronary Artery Bypass, Off-Pump/methods , Coronary Artery Disease/surgery , Registries , Aged , Coronary Angiography , Coronary Artery Disease/diagnosis , Coronary Artery Disease/mortality , Female , Humans , Incidence , Male , Myocardial Revascularization , Postoperative Complications/epidemiology , Retrospective Studies , Survival Rate/trends , Time Factors , Treatment Outcome , United Kingdom/epidemiology
14.
J Thorac Cardiovasc Surg ; 154(1): 81-86, 2017 07.
Article in English | MEDLINE | ID: mdl-28420536

ABSTRACT

BACKGROUND: Although generally better outcomes are reported in patients undergoing early repair of type A aortic dissection, patients who survive the first 48 hours self-select themselves toward better outcomes as well. Malperfusion is another important determinant of outcome in these patients. The aim of this study was to examine the hypothesis that malperfusion, not the timing of operation, is the dominant determinant of outcome in repair of type A aortic dissection. METHODS: A total of 205 patients underwent operative repair of acute type A aortic dissection in our hospital over a 17-year period. The time from symptom onset to surgical repair was reliably established in 152 cases. Patients were grouped into those who had undergone surgery within 12 hours of symptom onset (early surgery group; n = 72 [47%]) and those who underwent surgery beyond 12 hours of symptom onset (late surgery group; n = 80 [53%]). RESULTS: Thirty-day mortality was similar in the 2 groups (early surgery: 19.4% [95% confidence interval [CI] 12.0%-30.6%]; late surgery: 13.8% [95% CI, 7.9%-23.5%]; P = .08). The log-rank test for equality of survivor functions was 0.08. However, malperfusion with hemodynamic compromise was more common in the early surgery group (47% vs 31%; P = .029) and was identified as an independent predictor of long-term mortality (hazard ratio, 2.65; 95% CI, 1.21-5.79; P = .014). CONCLUSIONS: Malperfusion at presentation rather than timing of intervention is the major risk factor of death both in the hospital and at long-term follow-up in patients undergoing surgery for type A aortic dissection.


Subject(s)
Aortic Dissection/surgery , Aged , Aortic Dissection/complications , Aortic Dissection/mortality , Aortic Dissection/physiopathology , Blood Circulation , Female , Hemodynamics , Humans , Male , Middle Aged , Risk Factors , Survival Analysis , Time Factors
16.
J Thorac Cardiovasc Surg ; 153(2): 300-309.e6, 2017 02.
Article in English | MEDLINE | ID: mdl-27955911

ABSTRACT

OBJECTIVES: There is growing concern that off-pump coronary artery bypass (OPCAB) is associated with reduced long-term survival compared with traditional on-pump coronary artery bypass (ONCAB); however, most of available comparisons between OPCAB and ONCAB focus on single-artery (SA) revascularization. We sought to investigate the impact of using multiple arterial (MA) conduits in the comparison between OPCAB versus ONCAB by performing a single-center, long-term propensity score base analysis. METHODS: The study population included 5195 SA-ONCAB, 1208 MA-ONCAB, 4412 SA-OPCAB, and 1818 MA-OPCAB procedures. Late survival was available for all cases (100%). Inverse propensity score weighting and a time-segmented Cox model were used for multiple treatments comparison. RESULTS: No significant differences were found between the 4 groups in terms of 30-day mortality, postoperative cerebrovascular accident, and renal replacement therapy. After a mean follow-up time of 8.2 ± 4.7 years, in the propensity score-weighted sample, survival probabilities at 10 years were 74.5 ± 0.4, 79.7 ± 0.4, 73.4 ± 0.5, and 79.0 ± 0.5 in the SA-ONCAB, MA-ONCAB, SA-OPCAB, and MA-OPCAB groups respectively. Propensity-weighted analysis confirmed that MA-OPCAB (hazard ratio, 0.81; 95% confidence interval, 0.69-0.98) and MA-ONCAB (hazard ratio, 0.81; 95% confidence interval, 0.65-0.99) were associated with a lower late mortality compared with standard SA-ONCAB. CONCLUSIONS: OPCAB with multiple arterial grafts is as safe as the conventional ONCAB and achieves excellent long term survival rates which are superior to those observed after standard SA-ONCAB and comparable with MA-ONCAB.


Subject(s)
Blood Vessel Prosthesis , Coronary Artery Bypass/methods , Coronary Artery Disease/surgery , Coronary Vessels/surgery , Propensity Score , Aged , Coronary Artery Bypass, Off-Pump/methods , Coronary Artery Disease/diagnosis , Coronary Vessels/diagnostic imaging , Coronary Vessels/physiopathology , Female , Follow-Up Studies , Humans , Incidence , Male , Middle Aged , Postoperative Complications/epidemiology , Prosthesis Design , Retrospective Studies , Survival Rate/trends , Time Factors , Treatment Outcome , United Kingdom/epidemiology , Vascular Patency
17.
J Thorac Cardiovasc Surg ; 153(1): 79-88.e4, 2017 01.
Article in English | MEDLINE | ID: mdl-27697357

ABSTRACT

OBJECTIVES: We conducted propensity score matching to determine whether the use of the right internal thoracic artery (RITA) confers a survival advantage when compared with the radial artery (RA) as second arterial conduit in coronary artery bypass grafting. METHODS: The study population included a highly selected low-risk group of patients who received the RITA (n = 764) or the RA (n = 1990) as second arterial conduit. We obtained 764 matched pairs that were comparable for all pretreatment variables. A time-segmented Cox regression model that stratified on the matched pairs was used to investigate the effect of treatment on late mortality. RESULTS: After a mean follow-up of 10.2 ± 4.5 years (maximum 17.3 years), survival probabilities at 5, 10, and 15 years were 96.4% ± 0.7% versus 95.4% ± 0.7%, 91.0% ± 1.1% versus 89.1% ± 1.2%, and 82.4% ± 1.9% versus 77.2% ± 2.5% in the RITA and RA groups, respectively. During the first 4 years, RITA and RA were comparable in terms of mortality (hazard ratio [HR], 1.00; 95% confidence interval [CI], 0.56-1.78; P = .98). However, after 4 years RITA was associated with a significant reduction in late mortality (HR, 0.67; 95% CI, 0.48-0.95; P = .02). RITA was superior to RA when the experimental conduit was used to graft the left coronary system (HR, 0.69; 95% CI, 0.47-0.99; P = .04) but not the right coronary system (HR, 0.98; 95% CI, 0.59-1.62; P = .93). CONCLUSIONS: In a highly selected low-risk group of patients, the use of the RITA as second arterial conduit instead of the RA was associated with better survival when used to graft the left but not the right coronary artery.


Subject(s)
Coronary Artery Bypass/methods , Mammary Arteries/transplantation , Radial Artery/transplantation , Aged , Aged, 80 and over , Coronary Artery Bypass/mortality , Female , Follow-Up Studies , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Propensity Score , Proportional Hazards Models , Risk Factors , Survival Analysis , Time Factors
18.
JAMA Intern Med ; 177(1): 79-86, 2017 01 01.
Article in English | MEDLINE | ID: mdl-27820610

ABSTRACT

Importance: Postmarket evidence generation for medical devices is important yet limited for prosthetic aortic valve devices in the United Kingdom. Objective: To identify prosthetic aortic valve models that display unexpected patterns of mortality or reintervention using routinely collected national registry data and record linkage. Design, Setting, and Participants: This observational study used data from all National Health Service and private hospitals in England and Wales that submit data to the National Adult Cardiac Surgery Audit (NACSA). All patients undergoing first-time elective and urgent aortic valve replacement surgery (with or without coronary artery bypass grafting) with a biological (n = 15 series) or mechanical (n = 10 series) prosthetic valve from 5 primary suppliers, and satisfying prespecified data quality criteria (n = 43 782 biological; n = 11 084 mechanical) between 1998 and 2013 were included. Valves were classified into series of related models. Outcome tracking was performed using multifaceted record linkage. The median follow-up was 4.1 years (maximum, 15.3 years). Cox proportional hazards regression with random effects (frailty models) were used to model valve effects on the outcomes, with and without adjustment for preoperative and intraoperative covariates. Main Outcomes and Measures: Time to all-cause mortality or aortic valve reintervention (surgical or transcatheter). There were 13 104 deaths and 723 reinterventions during follow-up. Results: Of 79 345 isolated aortic valve replacement procedures with or without coronary artery bypass grafting, 54 866 were analyzed. Biological valve implantation rates increased from 59% in 1998 and 1999 to 86% in 2012 and 2013. Two series of valves associated with significantly increased hazard of death or reintervention were identified (first series: frailty, 1.18; 95% prediction interval [PI], 1.06-1.32 and second series: frailty, 1.19; 95% PI, 1.09-1.31). These results were robust to covariate adjustment and sensitivity analyses. There were 3 prosthetic valves with a significant reduction in hazard (valve 1: frailty, 0.88; 95% PI, 0.80-0.96; valve 2: frailty, 0.88; 95% PI, 0.80-0.96; and valve 3: frailty, 0.88; 95% PI, 0.78-0.98). Conclusions and Relevance: Meaningful evidence from the analysis of routinely collected registry data can inform postmarket surveillance of medical devices. Although the findings are associated with a number of caveats, 2 specific biological aortic valve series identified in this study may warrant further investigation.


Subject(s)
Aortic Valve , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Medical Record Linkage , Product Surveillance, Postmarketing , Registries , England/epidemiology , Follow-Up Studies , Heart Valve Prosthesis Implantation/mortality , Humans , Outcome Assessment, Health Care , Reoperation/statistics & numerical data , Risk Factors , Survival Rate , Wales
19.
J Thorac Dis ; 8(Suppl 10): S758-S771, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27942394

ABSTRACT

Coronary artery bypass grafting remains the standard treatment for patients with extensive coronary artery disease. Coronary surgery without use of cardiopulmonary bypass avoids the deleterious systemic inflammatory effects of the extracorporeal circuit. However there is an ongoing debate surrounding the clinical outcomes after on-pump versus off-pump coronary artery bypass (ONCAB versus OPCAB) surgery. The current review is based on evidence from randomized controlled trials (RCTs) and meta-analyses of randomized studies. It focuses on operative mortality, mid- and long-term survival, graft patency, completeness of revascularisation, neurologic and neurophysiologic outcomes, perioperative complications and outcomes in the high risk groups. Early and late survival rates for both OPCAB and ONCAB grafting are similar. Some studies suggest early poorer vein graft patency with off-pump when compared with on-pump, comparable midterm arterial conduit patency with no difference in long term venous and arterial graft patency. A recent, pooled analysis of randomised trials shows a reduction in stroke rates with use off-pump techniques. Furthermore, OPCAB grafting seems to reduce postoperative renal dysfunction, bleeding, transfusion requirement and respiratory complications while perioperative myocardial infarction rates are similar to ONCAB grafting. The high risk patient groups seem to benefit from off-pump coronary surgery.

20.
J Thorac Dis ; 8(Suppl 10): S795-S798, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27942397

ABSTRACT

The role of off-pump coronary artery bypass (OPCAB) grafting in high risk patients remains controversial. While there have been studies showing the potential benefits of it, there is still a lot to be learned from the application of this technique in this sub-group of patients. The results of the different trials and papers that we reviewed seem to indicate a benefit in the OPCAB group. Despite of the fact that trials were significantly different in methodology, especially when choosing the risk score stratification tool or the cut-off to define high risk the literature seems to suggest a benefit from the use of OPCAB surgery. Here, we present a review which focussed on early and late outcome in high risk patients undergoing on- and off-pump coronary revascularization.

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