Long-term survival after surgical treatment for post-infarction mechanical complications: results from the Caution study.

BACKGROUND AND AIMS: Mechanical complications (MCs) are rare but potentially fatal sequelae of acute myocardial infarction (AMI). Surgery, though challenging, is considered the treatment of choice. The authors sought to study early and long-term results of patients undergoing surgical treatment for post-AMI MCs. METHODS: Patients undergone surgical treatment for post-infarction MCs between 2001 through 2019 in 27 centers worldwide were retrieved from the database of CAUTION study. In-hospital and long-term mortality were the primary outcomes. Cox proportional hazards regression models were used to determine independent factors associated with overall mortality. RESULTS: The study included 720 patients. The median age was 70.0 [62.0-77.0] years, with a male predominance (64.6%). The most common MC encountered was ventricular septal rupture (VSR) (59.4%). Cardiogenic shock was seen on presentation in 56.1% of patients. In-hospital mortality rate was 37.4%; in more than 50% of cases, the cause of death was low cardiac output syndrome (LCOS). Late mortality occurred in 133 patients, with a median follow-up of 4.4 [1.0-8.6] years. Overall survival at 1, 5 and 10 years was 54.0%, 48.1% and 41.0%, respectively. Older age (p < 0.001) and postoperative LCOS (p < 0.001) were independent predictors of overall mortality. For hospital survivors, 10-year survival was 65.7% and was significant higher for patients with VSR than those with papillary muscle rupture (long-rank P = 0.022). CONCLUSIONS: Contemporary data from a multicenter cohort study show that surgical treatment for post-AMI MCs continues to be associated with high in-hospital mortality rates. However, long-term survival in patients surviving the immediate postoperative period is encouraging.Trial registration number: NCT03848429.

Contemporary outcomes of cardiac surgery patients supported by the intra-aortic balloon pump.

OBJECTIVES: Although the intra-aortic balloon pump (IABP) has been the most widely adopted temporary mechanical support device in cardiac surgical patients, its use has declined. The current study aimed to evaluate the occurrence and predictors of early mortality and complication rates in contemporary cardiac surgery patients supported by an IABP. METHODS: A multicentre, retrospective analysis was performed of all consecutive cardiac surgical patients receiving perioperative balloon pump support in 8 centres between January 2010 to December 2019. The primary outcome was early mortality, and secondary outcomes were balloon-associated complications. A multivariable binary logistic regression model was applied to evaluate predictors of the primary outcome. RESULTS: The study cohort consisted of 2615 consecutive patients. The median age was 68 years [25th percentile 61, 75th percentile 75 years], with the majority being male (76.9%), and a mean calculated 30-day mortality risk of 10.0%. Early mortality was 12.7% (n = 333), due to cardiac causes (n = 266), neurological causes (=22), balloon-related causes (n = 5) and other causes (n = 40). A composite end point of all vascular complications occurred in 7.2% of patients, and leg ischaemia was observed in 1.3% of patients. The most important predictors of early mortality were peripheral vascular disease [odds ratio (OR) 1.63], postoperative dialysis requirement (OR 10.40) and vascular complications (OR 2.57). CONCLUSIONS: The use of the perioperative IABP proved to be safe and demonstrated relatively low complication rates, particularly for leg ischaemia. As such, we believe that specialists should not be held back to use this widely available treatment in high-risk cardiac surgical patients when indicated.

Antecedent ACE-inhibition, inflammatory response, and cardiac surgery associated acute kidney injury.

Cardiopulmonary bypass (CPB) may trigger organs damage, including kidney injury, due to a massive cytokine release. In this observational, prospective study, we analyzed the possible impact of chronic treatment with ACE-Inhibitors (ACE-I) on the inflammatory response and renal function after CPB. Sixty-nine patients undergoing major cardiac surgery with CPB were enrolled. Patients were stratified according to long-term (> 6 mo.) ACE-I use (n = 38) or not (n = 31). The primary endpoint was the change in IL-1alpha, IL-1beta, IL-2, IL-4, IL-6, IL-8, IL-10, TNF alpha, EGF and VEGF plasma levels. Secondary (renal) endpoints were postoperative acute kidney injury (AKI), recovery of baseline GFR values and the absolute changes in renal function indexes. After CPB, IL-1alpha, IL-1beta, IL-4 and TNF-alpha remained stable over time while a significant decrease in IL-2 levels was noticed in the ACE-I group (p = 0.01). IL-6 and IL-8 increased after surgery and tended to decrease after 48 h. IL-10 levels showed a similar variation, but both their rise and decrease were more pronounced in patients under ACE-I treatment (p = 0.007). Finally, VEGF and EGF showed a marked initial decrease with a tendency to normalization 10 days after surgery (p for trend ranging from 0.01 to 0.001). The occurrence of AKI within 2 days after surgery, the rate of GFR recovery and the absolute changes in renal function indexes were not statistically different between groups. Chronic, long-term ACE-I treatment may influence the inflammatory response following CPB. On the other hand, this drug class apparently has neutral impact on perioperative renal outcomes.

Relation of Prolonged Pacemaker Dependency After Cardiac Surgery to Mortality.

Permanent pacemaker implantation (PPI) represents a rare complication after cardiac surgery, with no uniform agreement on timing and no information on follow-up. A multicenter retrospective study was designed to assess pacemaker dependency (PMD) and long-term mortality after cardiac surgery procedures. Between 2004 and 2016, PPI-patients from 18 centers were followed. Time-to-event data were evaluated with semiparametric regression Cox models and semiparametric Fine and Gray model for competing risk framework. Of 859 (0.90%) PPI-patients, 30% were pacemaker independent (PMI) at 6 months. PMD showed higher mortality compared with PMI (10-year survival 80.1% ± 2.6% and 92.2% +2.4%, respectively, log-rank p-value < 0.001) with an unadjusted hazard ratio for death of 0.36 (95% CI 0.20 to 0.65, p< 0.001 favoring PMI) and an adjusted hazard ratio of 0.19 (95% CI 0.08 to 0.45, p< 0.001 with PMD as reference). Crude cumulative incidence function of restored PMI rhythm at follow-up at 6 months, 1 year and 12 years were 30.5% (95% CI 27.3% to 33.7%), 33.7% (95% CI 30.4% to 36.9%) and 37.2% (95% CI 33.8% to 40.6%) respectively. PMI was favored by preoperative sinus rhythm with normal conduction (SR) (HR 2.37, 95% CI 1.65 to 3.40, p< 0.001), whereas coronary artery bypass grafting and aortic valve replacement were independently associated with PMD (HR 0.63, 95% CI 0.45 to 0.88, p = 0.006 and HR 0.807, 95% CI 0.65 to 0.99, p = 0.047 respectively). Time-to-implantation was not associated with increased rate of PMI. Although 30% of PPI-patients are PMI after 6 months, PMD is associated with higher mortality at long term.

Mitral Valve Replacement With a Third-Generation Porcine Valve: An Italian Multicentered Study.

BACKGROUND: Postoperative outcomes of a third-generation porcine bioprosthesis for mitral valve replacement (MVR) have been poorly addressed. The objective of this study was to perform an independent, retrospective, multicenter study on outcomes of patients undergoing MVR with a Mosaic (Medtronic Inc, Minneapolis, MN) porcine bioprosthesis. METHODS: From 1998 to 2011, 805 patients underwent MVR with a Mosaic porcine valve in 11 cardiac centers. There were 465 female patients (58%), and the overall mean age was 73.5 ± 7 years. Associated procedures included coronary artery bypass grafting (201 patients; 24.9%), aortic valve replacement (152 patients; 18.9%), tricuspid annuloplasty (187 patients; 22.3%), and other cardiac procedures (116 patients; 14.4%). RESULTS: Median follow-up was 44 months (interquartile range, 16 to 63), with a cumulative duration of 2.769 patient-years. Early mortality for isolated elective MVR was 3.8% (12 of 313), and overall early mortality was 7.8% (n = 63). The rate of late mortality was 3.4%/patient-year (95 late deaths). At 10 years, overall survival was 57.4% (95% confidence interval [CI], 48.8% to 67.5%), and cumulative rates of cardiac- and valve-related death were 7.4% (95% CI, 4.8% to 10.1%) and 1.1% (95% CI, 0.2% to 1.9%), respectively. The 10-year cumulative rates of thromboembolic and hemorrhagic events were 6.6% (95% CI, 1.4% to 11.8%) and 3.9% (95% CI, 0.1% to 8%), respectively, and the 10-year cumulative incidence of prosthetic valve endocarditis was 3% (95% CI, 1.2% to 4.9%). Finally, the 10-year cumulative incidences of structural valve degeneration and reoperations were 5.8% (95% CI, 0.2% to 11.5%) and 4.8% (95% CI, 0.7% to 10.3%), respectively. CONCLUSIONS: This independent, multicenter, retrospective study indicated that the Mosaic porcine bioprosthesis for MVR provides satisfactory results in terms of both early and long-term outcomes up to 14 years from its implantation.

Incidence and prognostic impact of bleeding and transfusion after coronary surgery in low-risk patients.

BACKGROUND: Excessive bleeding and blood transfusion are associated with adverse outcome after cardiac surgery, but their mechanistic effects are difficult to disentangle in patients with increased operative risk. This study aimed to evaluate the incidence and prognostic impact of bleeding and transfusion of blood products in low-risk patients undergoing coronary artery bypass grafting (CABG). STUDY DESIGN AND METHODS: Sixteen tertiary European centers of cardiac surgery contributed to the prospective European registry of CABG (E-CABG). The severity of bleeding was defined by the E-CABG bleeding severity classification and universal definition of perioperative bleeding (UDPB) classification. RESULTS: Of 1213 patients with EuroSCORE II of less than 2% (mean, 1.1 ± 0.4%), 18.5% suffered from mild bleeding (E-CABG bleeding Grade 1) and 3.4% experienced severe bleeding (E-CABG bleeding Grade 2-3). Similarly, 19.7% had UDPB Class 2 and 5.9% had UDPB Classes 3 and 4. Mild and severe bleeding defined by the E-CABG and UDPB classifications were associated with an increased risk of several adverse events as adjusted by multiple covariates. The risk of death, stroke, and acute kidney injury was particularly increased in patients with severe bleeding. CONCLUSION: Severe bleeding is rather uncommon in low-risk patients undergoing CABG, but it is associated with an increased risk of major adverse events. Prevention of excessive perioperative bleeding and patient blood management may improve the outcome of cardiac surgery also in low-risk patients.

Antiplatelet versus oral anticoagulant therapy as antithrombotic prophylaxis after mitral valve repair.

OBJECTIVE: To verify the rate of thromboembolic and hemorrhagic complications during the first 6 months after mitral valve repair and to assess whether the type of antithrombotic therapy influenced clinical outcome. METHODS: Retrospective data were retrieved from 19 centers. Inclusion criteria were isolated mitral valve repair with ring implantation. Exclusion criteria were ongoing or past atrial fibrillation and any combined intraoperative surgical procedures. The study cohort consisted of 1882 patients (aged 58 ± 15 years; 36% women), and included 1517 treated with an oral anticoagulant (VKA group) and 365 with antiplatelet drugs (APLT group). Primary efficacy outcome was the incidence of arterial thromboembolic events within 6 months and primary safety outcome was the incidence of major bleeding within 6 months. Propensity matching was performed to obtain 2 comparable cohorts (858 vs 286). RESULTS: No differences were detected for arterial embolic complications in matched cohort (1.6% VKA vs 2.1% APLT; P = .50). Conversely, patients in the APLT group showed lower incidence of major bleeding complications (3.9% vs 0.7%; P = .01). Six-month mortality rate was significantly higher in the VKA group (2.7% vs 0.3%; P = .02). Multivariable analysis in the matched cohort found VKA as independent predictor of major bleeding complications and mortality at 6 months. CONCLUSIONS: Vitamin K antagonist therapy was not superior to antiplatelet therapy to prevent thromboembolic complications after mitral valve repair. Our data suggest that oral anticoagulation may carry a higher bleeding risk compared with antiplatelet therapy, although these results should be confirmed in an adequately powered randomized controlled trial.

Surgical ablation in patients undergoing mitral valve surgery: impact of lesion set and surgical techniques on long-term success.

AIMS: To assess the results and impact of lesion set and surgical technique on long-term success of surgical ablation during mitral surgery. METHODS AND RESULTS: The patient population consisted of 685 subjects with persistent and long-standing persistent atrial fibrillation (AF) undergoing cardiac surgery for mitral valve disease as the primary indication and concomitant ablation between January 2003 and January 2012 at three institutions. One hundred and sixty-six underwent unipolar (24.2%), 371 (54.2%) bipolar, and 148 (21.6%) had combined ablation. Median follow-up was 58.4 months (interquartile range 43.3-67.9). To appropriately account for death, a competing risk model was employed to identify predictors of cumulative incidence of recurrent AF among lesion set and surgical techniques. Eight-year freedom from recurrent arrhythmia without antiarrhythmic drugs was 0.60 ± 0.02. Success rate was higher using bipolar radiofrequency (RF) (P < 0.001), after performing mitral isthmus line (P = 0.003) and following the biatrial technique (P < 0.001). Competing risk regression revealed that use of unipolar RF [sub-hazard ratio (SHR) 2.41 (1.52-3.43), P < 0.001], combined unipolar/bipolar ablation [SHR 1.93 (0.89-2.57), P = 0.003] and the absence of right atrial ablation [SHR 2.79 (1.27-3.48), P < 0.001] were predictors of cumulative incidence of long-term recurrence. CONCLUSIONS: Our experience suggests that the use of bipolar clamp improves long-term results in surgical treatment of AF and that right-sided ablation should be routinely added. Randomized studies are necessary to confirm our findings.

Acute kidney injury after composite valve-graft replacement for ascending aorta aneurysms.

Acute kidney injury (AKI) following cardiac surgery is a continuing source of morbidity and mortality. Although several studies have attempted to determine its etiology and prophylactic measures, limited data exist after thoracic aortic surgery. The aim of this study was to evaluate the incidence and predictors of AKI in patients undergoing aortic root replacement (ARR) with valve conduit for ascending aorta aneurysms. A multi-center observational study of 414 patients undergoing ARR with a valve conduit was conducted, focusing on clinical outcome and AKI defined by consensus RIFLE (risk, injury, failure, loss of function, end-stage renal disease) criteria. Mean age was 62.5 years (range: 21-82 years) with 327 males (79%). Emergent operations were performed in 5% of the cases, while concomitant surgical procedures were performed in 24.9%. Postoperative AKI (all RIFLE classes) occurred in 69 (16.7%) patients, while eight (1.9%) required dialysis. Independent AKI predictors were packed red blood cells (pRBCs) >4 units (OR 2.28; 95% CI 1.20-4.30), cardiopulmonary bypass (CPB) time longer than 180 min (OR, 2.08; 95% CI, 1.16-3.73), and concomitant surgical procedures (OR, 1.85; 95% CI, 1.04-3.29). The severity of RIFLE class was associated with longer ICU stay, hospitalization, and higher hospital mortality (p < 0.001 for each variable). AKI after ARR operations with valve conduit for ascending aorta aneurysms increases utilization of health resources and is associated with adverse events. Concomitant surgical procedures, prolonged CPB-time, and pRBCs >4 units as independent AKI predictors merit further researches enhancing possible preventive strategies.

Mitral valve repair or replacement for ischemic mitral regurgitation? The Italian Study on the Treatment of Ischemic Mitral Regurgitation (ISTIMIR).

OBJECTIVE: It is uncertain whether mitral valve replacement is really inferior to mitral valve repair for the treatment of chronic ischemic mitral regurgitation. This multicenter study aimed at providing a contribution to this issue. METHODS: Of 1006 patients with chronic ischemic mitral regurgitation and impaired left ventricular function (ejection fraction < 40%) operated on at 13 Italian institutions between 1996 and 2011, 298 (29.6%) underwent mitral valve replacement whereas 708 (70.4%) received mitral valve repair. Propensity scores were calculated by a nonparsimonious multivariable logistic regression, and 244 pairs of patients were matched successfully using calipers of width 0.2 standard deviation of the logit of the propensity scores. The postmatching median standardized difference was 0.024 (range, 0-0.037) and in none of the covariates did it exceed 10%. RESULTS: Early deaths were 3.3% (n = 8) in mitral valve repair versus 5.3% (n = 13) in mitral valve replacement (P = .32). Eight-year survival was 81.6% ± 2.8% and 79.6% ± 4.8% (P = .42), respectively. Actual freedom from all-cause reoperation and valve-related reoperation were 64.3% ± 4.3% versus 80% ± 4.1%, and 71.3% ± 3.5% versus 85.5% ± 3.9 in mitral valve repair and mitral valve replacement, respectively (P < .001). Actual freedom from all valve-related complications was 68.3% ± 3.1% versus 69.9% ± 3.3% in mitral valve repair and mitral valve replacement, respectively (P = .78). Left ventricular function did not improved significantly, and it was comparable in the 2 groups postoperatively (36.9% vs 38.5%, P = .66). At competing regression analysis, mitral valve repair was a strong predictor of reoperation (hazard ratio, 2.84; P < .001). CONCLUSIONS: Mitral valve replacement is a suitable option for patients with chronic ischemic mitral regurgitation and impaired left ventricular function. It provides better results in terms of freedom from reoperation with comparable valve-related complication rates.

Impact of lesion sets on mid-term results of surgical ablation procedure for atrial fibrillation.

OBJECTIVES: The objective of this study was to evaluate the effects of different lesion sets of ablation in patients undergoing mitral surgery plus maze. BACKGROUND: The role of lesion sets on outcome after maze is poorly defined. METHODS: A total of 141 patients were prospectively followed up. Two different lesion sets were prepared: 32 patients underwent a radiofrequency left atrial lesion set of maze ("limited"), and 109 had combined left and right atrial lesion sets of maze ± ganglionic plexi isolation ("extensive"). A longitudinal observational study assessed the role of "extensive" versus "limited" ablation on atrial fibrillation (AF), New York Heart Association (NYHA) functional class II/III, treatment with antiarrhythmic drugs, follow-up recovery of the ratio of E- to A-wave (E/A), and survival and time to hospitalization (overall and for heart failure). RESULTS: The prevalence of AF over time was lower in the "extensive" arm (adjusted relative risk [RR]: 0.10; 95% confidence interval [CI]: 0.03 to 0.31; p < 0.001), with significantly lower prevalence at discharge, 3 months, and 18 months. The prevalence of patients in NYHA functional class II/III over time was lower in the "extensive" arm (adjusted RR: 0.11; 95% CI: 0.03 to 0.34; p < 0.001), with significant differences at any assessment (except the third month). The differences in E/A recovery and use of antiarrhythmic drugs were less marked, with an RR of 1.55 (95% CI: 0.99 to 2.42; p = 0.05) and RR of 0.76 (95% CI: 0.54 to 1.06; p = 0.11), respectively, with a significantly lower prevalence of antiarrhythmic drugs in the "extensive" ablation arm at 12, 18, and 24 months. Rates of hospitalization for heart failure, overall hospitalization, and the combined event death/hospitalization were lower in the "extensive" arm (p = 0.11, p = 0.003, and p = 0.002, respectively). CONCLUSIONS: The addition of right-sided ablation improves clinical and electrophysiologic results after maze procedure.

Mid-term echocardiographic results with different rings following restrictive mitral annuloplasty for ischaemic cardiomiopathy.

BACKGROUND: Despite restrictive mitral annuloplasty (RMA) being considered effective for chronic ischaemic mitral regurgitation (CIMR), few data exist on mid-term echocardiographic results with different prosthetic rings. Therefore, comparative echocardiographic analysis has been performed. METHODS: Sixty-four consecutive coronary artery bypass graft surgery (CABG) + RMA (downsizing by two-ring sizes; median size: 26 mm) for CIMR with a follow-up of at least 6 months were prospectively followed-up with serial echocardiograms (preoperative, discharge, 6 months, follow-up ending). Hospital mortality, follow-up clinical and echocardiographic results were analysed and compared between three groups (group A: semi-rigid band, 17 patients; group B: complete symmetric semi-rigid, 22 patients; group C: complete asymmetric semi-rigid, 25 patients). RESULTS: Hospital mortality was 6.3%; 22.8 +/- 14.7 standard deviation (SD) months (range: 6-55) survival was 96.5 +/- 2.5%; freedom from re-intervention was 94.2 +/- 4.2%, from re-revascularisation 87.5 +/- 11.7%, from > or = grade-2 mitral regurgitation 58.2 +/- 9.8% and from heart failure (CHF) 71.6 +/- 10.5%. Recurrent (> or = grade-2) CIMR resulted in lower freedom-from-CHF (p = 0.0001), worsened New York Heart Association (NYHA) classification (p = 0.0001) and absence of reverse remodelling of the left ventricular end-diastolic diameter (LVEDD; p = 0.004), systolic diameter (LVESD; p = 0.014), indexed mass (LVMi; p = 0.005) and coaptation depth (p = 0.0001). Group A showed significant worse freedom from CHF (group A: 42.8 +/- 19.5% vs group B: 88.9 +/- 10.5% vs group C: 92.3 +/- 7.5%; p = 0.049) and from recurrent CIMR (17.4 +/- 13.8% vs 82.1 +/- 11.7% vs 94.1 +/- 5.7%, respectively; p = 0.0001). Complete rings decreased the hazard of recurrent CIMR (Physio = 0.141; Adams = 0.089). Higher NYHA during follow-up was found in group A (p = 0.002 for group B and p = 0.001 for group C) with a progressive reduction of trans-mitral mean gradient (p = 0.001), and a lower degree of reverse remodelling of LVEDD (p = 0.009 and p = 0.010) and coaptation depth (p = 0.040 and p = 0.002). CONCLUSIONS: Recurrent CIMR correlates with absent ventricular reverse remodelling. Despite a higher trans-mitral gradient, complete rings achieve better results in the treatment of CIMR.

Safety and efficacy of transbrachial intra-aortic balloon pumping with the use of 7-Fr catheters in patients undergoing coronary bypass surgery.

We report the cases of five consecutive patients undergoing coronary artery bypass grafting (CABG) who required a transbrachial approach for 7-Fr catheter intra-aortic balloon pumping (IABP) insertion because of unsuitable femoral arteries. No adverse outcomes occurred in any patient during a mean 72 h of IABP support. Our experience with 7-Fr catheters appears to confirm previous reports of the safety and efficacy of transbrachial IABP assistance and suggests that such support can be provided safely for an extended duration with the use of these smaller catheters.

Results of atrial fibrillation ablation during mitral surgery in patients with poor electro-anatomical substrate.

BACKGROUND AND AIM OF THE STUDY: Enlarged (> 50 mm) atria, longstanding (> 5 years) persistent atrial fibrillation (AF) and age > 70 years are considered predictive of recurrent AF following surgical ablation. The electrophysiological and clinical outcome after AF-ablation was evaluated in high-risk patients undergoing concomitant procedures. METHODS: Between January 2005 and January 2009, a total of 45 patients who complied with the three major predictors of failure, but who had undergone AF ablation ('left + right bipolar radiofrequency Maze') during concomitant mitral surgery were followed up. Freedom from AF, atrial flutter (AFL) and atrial tachycardia (AT), without anti-arrhythmic therapy (discontinued at the sixth month) was the primary endpoint. Survival, freedom from AF/AFL/AT with anti-arrhythmic therapy, early events during post-ablation blanking period, freedom from congestive heart failure (CHF) and from re-hospitalization, and changes in NYHA functional class were registered. RESULTS: Postoperatively, 18 patients (40%) showed sinus rhythm (SR) at admission to the intensive care unit, while 16 (26%) showed junctional rhythm and five (11%) required definitive pacemaker. Eleven of the 40 patients (28%) were discharged without a pacemaker, and experienced early events during the post-ablation blanking period. After a mean of 21 +/- 14 months' follow up, the actuarial survival was 88 +/- 7%. The prevalence of SR at six, 12, and 18 months was 74%, 64%, and 64% respectively. Freedom from AF/AFL/AT was 54 +/- 10% without anti-arrhythmic medications, and 51 +/- 9% with such drugs. Freedom from CHF was 85 +/- 6%, and significantly better in SR patients (94 +/- 6%) than in AF patients (69 +/- 13%; p = 0.018). Freedom from rehospitalization was 75 +/- 8%, and better in SR patients (94 +/- 6%) than in AF patients (37 +/- 14%; p = 0.0001). Accordingly, when compared to AF patients, the NYHA class was significantly ameliorated in SR patients at both six months (1.4 +/- 0.6 versus 2.7 +/- 0.9) and at the final follow up control (1.2 +/- 0.5 versus 1.9 +/- 0.7; p < 0.0001). The E/A wave recovered in 22 (85%) of the SR patients. CONCLUSION: AF ablation during mitral valve surgery achieves good electrophysiological results, even in patients traditionally considered as poor candidates. SR recovery allows a higher freedom from CHF and rehospitalization, with a better functional recovery when compared to AF.