BACKGROUND:The fibrosis-4 index (FIB-4) score, a noninvasive marker of subclinical liver fibrosis, has shown prognostic utility in general surgical populations. Current risk assessment models for patients with coronary artery disease undergoing percutaneous coronary intervention or coronary artery bypass grafting do not account for liver dysfunction apart from overt liver cirrhosis. We analyzed the distribution of the baseline FIB-4 score and its association with all-cause death in patients with coronary artery disease using data from the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) trial. METHODS:The baseline FIB-4 score was calculated for all ISCHEMIA randomized participants with laboratory data (platelet count, aspartate aminotransferase, and alanine aminotransferase). The primary outcome was the association between baseline FIB-4 and all-cause death. Secondary outcomes were cardiovascular death, heart failure, myocardial infarction, and stroke. Multivariable Cox regression was performed adjusting for key risk factors. RESULTS:The FIB-4 score was calculated for 3735 participants. Baseline FIB-4 score was significantly associated with an increased risk of all-cause (hazard ratio [HR], 1.19 [95% CI, 1.07-1.32]; P=0.001) and cardiovascular death (HR, 1.19 [95% CI, 1.04-1.36]; P=0.011). This association was consistent across the overall population and within subgroups of patients treated with percutaneous coronary intervention, coronary artery bypass grafting, and medical therapy. There was no significant association regarding heart failure, myocardial infarction, and stroke. CONCLUSIONS:The FIB-4 score may be a significant predictor of death in patients with coronary artery disease. Preprocedural hepatic assessment should be considered to stratify risk in patients undergoing invasive cardiac procedures.
BACKGROUND:Proton pump inhibitors (PPIs) are commonly prescribed for gastroprotection in patients undergoing percutaneous coronary intervention (PCI), who are at increased risk of gastrointestinal bleeding due to antiplatelet therapy. However, emerging evidence suggests that PPIs may adversely impact cardiovascular outcomes. This systematic review and meta-analysis sought to assess the relationship between using PPIs and cardiovascular outcomes in patients following PCI. METHODS:We searched various databases up to March 15, 2024, for observational studies and randomized controlled trials (RCTs) assessing the cardiovascular effects of PPIs in PCI patients. Data were extracted on study characteristics, patient demographics, PPI use, and cardiovascular outcomes. The Newcastle-Ottawa Scale and Cochrane Risk of Bias Tool 2 assessed study quality. Meta-analyses were conducted using a random-effects model using R software version 4.3. RESULTS:A total of 21 studies involving diverse populations and study designs were included. Observational studies suggested a moderate increase in risk for composite cardiovascular diseases (CVD), myocardial infarction (MI), and major adverse cardiac events (MACE) associated with PPI use, with pooled hazard ratios (HRs) of 1.20 (95% CI: 1.093-1.308) for CVD, 1.186 (95% CI: 1.069-1.303) for MI, and 1.155 (95% CI: 1.001-1.309) for MACE. However, RCTs showed no significant link between PPI therapy and negative cardiovascular events (Relative Risk: 1.016, 95% CI: 0.878-1.175). Substantial heterogeneity was observed among observational studies but not RCTs. CONCLUSION:The findings indicate that while observational studies suggest a potential risk of adverse cardiovascular events with post-PCI use of PPI, RCTs do not support this association. Further large-scale, high-quality studies are required to understand the cardiovascular implications of individual PPIs better and optimize patient management post-PCI. This analysis shows the complexity of PPI use in patients with coronary artery diseases and the necessity to balance gastroprotective benefits against potential cardiovascular risks.
Background This study aimed to assess the influence of the model of end-stage liver disease without International Normalized Ratio (INR) (MELD-XI) score on outcomes after elective coronary artery bypass surgery (CABG) without (Off-Pump) or with (On-Pump) cardiopulmonary bypass. Methods We calculated MELD-XI (5.11 x ln serum bilirubin + 11.76 x ln serum creatinine in + 9.44) for 3,535 consecutive patients having undergone elective CABG between 2009 and 2020. A MELD-XI threshold was determined using the Youden Index based on receiver operating characteristics. Propensity score matching and logistic regression was performed to identify risk factors for inhospital mortality and Major Adverse Cardiac and Cerebrovascular Event (MACCE). Results Patients were 68 +/- 10 years old (76% male). Average MELD-XI was 10.9 +/- 3.25. The MELD-XI threshold was 11. Patients below this threshold had somewhat lower EuroSCORE II than those above (3.5 +/- 4 vs. 4.1 +/- 4.7, p < 0.01), but mortality was almost four times higher above the threshold (below 1.5% vs. above 6.2%, p < 0.001). Two-thirds of patients received Off-Pump CABG. There was a trend towards higher risk in Off-Pump patients. Mortality was numerically but not statistically different to On-Pump below the MELD XI threshold (1.3 vs. 2.2%, p = 0.34) and was significantly lower above the threshold (4.9 vs. 8.9%, p < 0.02). Off-Pump above the threshold was also associated with less low-output syndrome and fewer strokes. Equalizing baseline differences by propensity matching verified the significant mortality difference above the threshold. Multivariable regression analysis revealed MELD-XI, On-Pump, atrial fibrillation, and the De Ritis quotient (Aspartate aminotransferase (ASAT)/Alanine Aminotransferase (ALAT)) as independent predictors of mortality. Conclusion Elective CABG patients with elevated MELD-XI scores are at increased risk for perioperative mortality and morbidity. This risk can be significantly mitigated by performing CABG Off-Pump.
Abstract Background In symptomatic high-risk patients with severe mitral valve regurgitation (MR), who are not eligible for surgery, Transcatheter edge-to-edge repair (TEER) or transcatheter mitral valve replacement (TMVR) may be an option, especially when surgical mitral valve repair by annuloplasty has been performed earlier. After TMVR, the appropriate anticoagulation regimen is still matter of debate. Case presentation We here report on a 78-year-old frail lady with heart failure and atrial fibrillation who underwent surgical reconstruction of the mitral valve nine years ago. Due to high surgical risk and after heart team discussion, TMVR using a transcatheter aortic valve prosthesis (valve-in-ring concept) was performed successfully via the transapical access route. Several months later, an excellent result could be confirmed. Since surgical excision of the left atrial appendage was carried out during first surgery, oral anticoagulation was withdrawn. Two months later, the patient presented with a massive LA thrombus mass and severe stenosis of the mitral valve prosthesis requiring re-do surgery. Conclusions Management of anticoagulation in patients with atrial fibrillation and successfully performed LAA excision is still a matter of debate, in particular after transcatheter heart valve implantation in mitral position. TMVR devices may be very thrombogenic. Thus, caution should be used whenever discontinuing oral anticoagulation in these patients. Despite the lack of evidence, withdrawal of anticoagulation should be avoided here, especially in the absence of bleeding complications. Left atrial appendage closure or excision should not influence this decision.
Background: Heated debates have arisen over potential advantages of avoiding cardiopulmonary bypass during coronary artery bypass grafting (Off-Pump CABG). Guidelines recommend Off-Pump in cases with elevated risks. Yet, in randomized patient populations, no survival advantage of Off-Pump has ever been documented. However, randomized patient populations mainly consist of selected low-risk individuals. One prohibitive risk factor for trials is liver cirrhosis, but earlier affections of liver function, such as liver fibrosis, have never been directly evaluated in CABG. We utilized the Fib-4 score to compare On-Pump and Off-Pump CABG in our elective or urgent CABG patients.
We report the rare case of a 51-year-old patient with a 15 cm mediastinal rhabdomyosarcoma with blood supply from the left anterior descending artery presenting as a large mass including the pericardium with extensive contact to the epicardium compressing heart and left lung. The tumor was successfully removed through median sternotomy, blunt dissection from the heart and the left lung, resection of the infiltrated pericardium, and ligation of the tumor-feeding vessels using off-pump stabilizers. Histopathological examination revealed a spindle cell rhabdomyosarcoma with R0 resection. The postoperative course was uneventful, and patient is feeling well at 3-month follow-up.
Central MessageFor optimal surgical care, we need to mobilize all our reserves and improve graft patency, including fractional flow (eg, multiarterial grafting, improved vein handling, and surgeon specialization).See Article page 74. For optimal surgical care, we need to mobilize all our reserves and improve graft patency, including fractional flow (eg, multiarterial grafting, improved vein handling, and surgeon specialization). See Article page 74. Ever since the introduction of percutaneous coronary intervention (PCI) for the treatment of chronic coronary artery disease (CAD), there has been hope of curing CAD mechanically without exposing the patient to much more invasive coronary artery bypass surgery (CABG). Hefty controversies have created somewhat of a “battlefield of PCI and CABG” (see the EXCEL trial data controversy1Cohan D. Brown E. Is the tide turning on the “grubby” affair of EXCEL and the European guidelines? 2020.https://www.medscape.com/viewarticle/939944Date accessed: September 11, 2020Google Scholar), where different guideline interpretations and possibly other incentives resulted in ratios of PCI to CABG performance ranging from approximately 2:1 in one country to more than 10:1 in the next.2Figulla H.R. Lauten A. Maier L.S. Sechtem U. Silber S. Thiele H. Percutaneous coronary intervention in stable coronary heart disease: is less more?.Dtsch Arztebl Int. 2020; 117: 137-144Google Scholar From a patient perspective, such differences should be acceptable only if treatment effects are similar. However, results may differ significantly,3Head S.J. Milojevic M. Daemen J. Ahn J.M. Boersma E. Christiansen E.H. et al.Mortality after coronary artery bypass grafting versus percutaneous coronary intervention with stenting for coronary artery disease: a pooled analysis of individual patient data.Lancet. 2018; 391: 939-948Abstract Full Text Full Text PDF PubMed Scopus (255) Google Scholar and we recently suggested that CABG and PCI differ in their mechanisms.4Doenst T. Haverich A. Serruys P. Bonow R.O. Kappetein P. Falk V. et al.PCI and CABG for treating stable coronary artery disease: JACC review topic of the week.J Am Coll Cardiol. 2019; 73: 964-976Crossref PubMed Scopus (82) Google Scholar CABG, in addition to revascularizing chronically ischemic myocardium, provides protection against new myocardial infarctions by creating “surgical collaterals.” Collaterals can prevent infarctions if a proximal coronary lesion causes vessel occlusion. This infarct preventative effect appears to be responsible for the survival effect of invasive CAD therapy.4Doenst T. Haverich A. Serruys P. Bonow R.O. Kappetein P. Falk V. et al.PCI and CABG for treating stable coronary artery disease: JACC review topic of the week.J Am Coll Cardiol. 2019; 73: 964-976Crossref PubMed Scopus (82) Google Scholar Since most infarct-causing lesions are not stented, CABG's advantage over PCI emerges with increasing risks for new myocardial infarctions.4Doenst T. Haverich A. Serruys P. Bonow R.O. Kappetein P. Falk V. et al.PCI and CABG for treating stable coronary artery disease: JACC review topic of the week.J Am Coll Cardiol. 2019; 73: 964-976Crossref PubMed Scopus (82) Google Scholar This effect requires patent bypass grafts; however, graft occlusions are common (up to 50% at 10 years5Gaudino M. Antoniades C. Benedetto U. Deb S. Di Franco A. Di Giammarco G. et al.Mechanisms, consequences, and prevention of coronary graft failure.Circulation. 2017; 136: 1749-1764Crossref PubMed Scopus (74) Google Scholar). Thus, it may be time to mobilize our reserves to improve graft patency, including multiarterial grafting, surgeon specialization, and/or improved vein harvesting and handling techniques.6Gaudino M. Benedetto U. Bakaeen F. Rahouma M. Tam D.Y. Abouarab A. et al.Off- versus on-pump coronary surgery and the effect of follow-up length and surgeons' experience: a meta-analysis.J Am Heart Assoc. 2018; 7: e010034Crossref PubMed Scopus (29) Google Scholar, 7Rosati C.M. Torregrossa G. Balkhy H.H. Puskas J.D. Dedicated training in advanced coronary surgery: need and opportunity.J Thorac Cardiovasc Surg. April 18, 2020; ([Epub ahead of print])Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar, 8Samano N. Geijer H. Liden M. Fremes S. Bodin L. Souza D. The no-touch saphenous vein for coronary artery bypass grafting maintains a patency, after 16 years, comparable to the left internal thoracic artery: a randomized trial.J Thorac Cardiovasc Surg. 2015; 150: 880-888Abstract Full Text Full Text PDF PubMed Scopus (131) Google Scholar, 9Taggart D.P. Webb C.M. Desouza A. Yadav R. Channon K.M. De Robertis F. et al.Long-term performance of an external stent for saphenous vein grafts: the VEST IV trial.J Cardiothorac Surg. 2018; 13: 117Crossref PubMed Scopus (19) Google Scholar Our current decision making for PCI or CABG is based on outcomes from the CABG trial, with patients not always having received our best. The collateralization hypothesis would require all diseased territories to be grafted. However, besides surgical technicalities, graft patency is also affected by the flow relevance of coronary lesions. Fractional flow reserve (FFR) assesses the functional flow relevance of coronary lesions and has improved outcomes in PCI (primarily by reducing the need for re-revascularization). In this issue of the Journal, Glineur and colleagues10Glineur D. Chong A.Y. Grau J. What should be the role of fractional flow reserve measurement in patients undergoing coronary artery bypass grafting?.J Thorac Cardiovasc Surg Open. 2021; 5: 74-79Google Scholar elegantly review the value of FFR for CABG. For fully arterial CABG, it indeed allows the prediction of graft occlusions. At an FFR value <0.78, 97% of grafts were perfect at 6 months. At higher values, the risk of occlusion increased, depending on graft targets (circumflex or right) and configuration (single vs sequential). Two findings appear to be most important in this context. First, the detected graft occlusions were clinically silent. Thus, grafting a diseased vessel with a 50% risk of occlusion would still provide infarct protection in the other 50% without adding harm. Second, vein grafts do not appear to be as sensitive to competitive flow, suggesting that other mechanisms may be more relevant for graft failure. Thus, applying strategies to improve vein patency, such as no-touch techniques8Samano N. Geijer H. Liden M. Fremes S. Bodin L. Souza D. The no-touch saphenous vein for coronary artery bypass grafting maintains a patency, after 16 years, comparable to the left internal thoracic artery: a randomized trial.J Thorac Cardiovasc Surg. 2015; 150: 880-888Abstract Full Text Full Text PDF PubMed Scopus (131) Google Scholar or external stenting,9Taggart D.P. Webb C.M. Desouza A. Yadav R. Channon K.M. De Robertis F. et al.Long-term performance of an external stent for saphenous vein grafts: the VEST IV trial.J Cardiothorac Surg. 2018; 13: 117Crossref PubMed Scopus (19) Google Scholar may be attractive options in case veins are required. Glineur and coauthors conclude that FFR should not be used to decide between PCI and CABG. However, it can be used to improve graft type selection and thereby enhance our ability to provide more patients with patent grafts. On the battlefield of invasive CAD therapy, graft patency is key.4Doenst T. Haverich A. Serruys P. Bonow R.O. Kappetein P. Falk V. et al.PCI and CABG for treating stable coronary artery disease: JACC review topic of the week.J Am Coll Cardiol. 2019; 73: 964-976Crossref PubMed Scopus (82) Google Scholar Therefore, it is time to mobilize all our reserves, with and without fractional flow. What should be the role of fractional flow reserve measurement in patients undergoing coronary artery bypass grafting?JTCVS OpenVol. 5PreviewFeature Editor's Introduction—Glineur and colleagues from Ottawa present a superb summary on the evidence of the use of fractional flow reserve (FFR) for coronary bypass surgery. FFR was conceived to guide percutaneous coronary interventions, a procedure that targets directly the culprit plaque and whose success is inversely related to the complexity and the numbers of the lesions treated. In this context, a tool able to identify the flow-limiting lesions and reduce the procedural complexity and the number of stents implanted makes obvious sense. Full-Text PDF Open Access
Central MessageParavalvular leaks are bad news. Correction seems beneficial. Even mild leaks limit long-term prognosis, but they are considered harmless with transcatheter valves. Long follow-up is thus crucial.See Article page 1785. Paravalvular leaks are bad news. Correction seems beneficial. Even mild leaks limit long-term prognosis, but they are considered harmless with transcatheter valves. Long follow-up is thus crucial. See Article page 1785. Classically, the diagnosis of a paravalvular leak (PVL) has made the surgeon feel uncomfortable, because it either reflects a technical blemish of surgical craftsmanship or signals a serious underlying pathology (eg, endocarditis or annular remodeling). Possibly as a consequence of the perceived surgical failure, the number of surgical publications on prognosis and management of paravalvular leaks is limited.1Kliger C. Eiros R. Isasti G. Einhorn B. Jelnin V. Cohen H. et al.Review of surgical prosthetic paravalvular leaks: diagnosis and catheter-based closure.Eur Heart J. 2013; 34: 638-649Crossref PubMed Scopus (122) Google Scholar It is well documented, however, that PVL increases risks for endocarditis and hemolytic anemia and, if severe, compromises hemodynamics.1Kliger C. Eiros R. Isasti G. Einhorn B. Jelnin V. Cohen H. et al.Review of surgical prosthetic paravalvular leaks: diagnosis and catheter-based closure.Eur Heart J. 2013; 34: 638-649Crossref PubMed Scopus (122) Google Scholar, 2Dávila-Román V.G. Waggoner A.D. Kennard E.D. Holubkov R. Jamieson W.R. Englberger L. et al.Artificial valve endocarditis reduction trial echocardiography study. Prevalence and severity of paravalvular regurgitation in the artificial valve endocarditis reduction trial (AVERT) echocardiography study.J Am Coll Cardiol. 2004; 44: 1467-1472Crossref PubMed Scopus (100) Google Scholar With the advent of catheter valve technology, the perception of PVL has changed. Initially, PVL was considered a major obstacle to transcatheter aortic valve implantation (TAVI), because severe PVL was frequent and poor survival was confirmed repeatedly.3Athappan G. Patvardhan E. Tuzcu E.M. Svensson L.G. Lemos P.A. Fraccaro C. et al.Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature.J Am Coll Cardiol. 2013; 61: 1585-1595Crossref PubMed Scopus (614) Google Scholar, 4Kodali S.K. Williams M.R. Smith C.R. Svensson L.G. Webb J.G. Makkar R.R. et al.PARTNER Trial InvestigatorsTwo-year outcomes after transcatheter or surgical aortic-valve replacement.N Engl J Med. 2012; 366: 1686-1695Crossref PubMed Scopus (1899) Google Scholar Technical progress has decreased the incidence of PVL, however, and most recent studies have found mild PVL to be harmless.3Athappan G. Patvardhan E. Tuzcu E.M. Svensson L.G. Lemos P.A. Fraccaro C. et al.Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature.J Am Coll Cardiol. 2013; 61: 1585-1595Crossref PubMed Scopus (614) Google Scholar, 5Vasa-Nicotera M. Sinning J.M. Chin D. Lim T.K. Spyt T. Jilaihawi H. et al.Impact of paravalvular leakage on outcome in patients after transcatheter aortic valve implantation.JACC Cardiovasc Interv. 2012; 5: 858-865Crossref PubMed Scopus (94) Google Scholar PVL thus does not seem to pose a considerable problem for the expansion of TAVI into patients at lower and lower risk undergoing aortic valve replacement.6Khan S.U. Lone A.N. Saleem M.A. Kaluski E. Transcatheter vs surgical aortic-valve replacement in low- to intermediate-surgical-risk candidates: a meta-analysis and systematic review.Clin Cardiol. 2017; 40: 974-981Crossref PubMed Scopus (21) Google Scholar In this issue of the Journal, Shah and colleauges7Shah S. Alashi A. Pettersson G.B. Rodriguez L.L. Gillinov A.M. Grimm R.A. et al.Characteristics and longer-term outcomes of paravalvular leak after aortic and mitral valve surgery.J Thorac Cardiovasc Surg. 2019; 157: 1785-1792.e1Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar present a large experience of purely surgical patients presenting with paravalvular leaks. They focused their analysis on patients who had an acceptable operative risk range and who were either conservatively or surgically treated (interventional techniques were reserved for patients with prohibitive surgical risk). Of almost 500 patients, the center decided to operate on two-thirds. In this surgical group, they found that despite excellent perioperative results, long-term mortality was high. They identified classic surgical risk factors as independent predictors of death, (ie, high Society of Thoracic Surgeons score, pulmonary hypertension, and endocarditis). They also found mitral leaks to be worse than aortic leaks. Shah and colleauges7Shah S. Alashi A. Pettersson G.B. Rodriguez L.L. Gillinov A.M. Grimm R.A. et al.Characteristics and longer-term outcomes of paravalvular leak after aortic and mitral valve surgery.J Thorac Cardiovasc Surg. 2019; 157: 1785-1792.e1Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar thus confirmed the TAVI literature, in which significant PVL has been found to affect survival negatively. The decision making of Shah and colleauges7Shah S. Alashi A. Pettersson G.B. Rodriguez L.L. Gillinov A.M. Grimm R.A. et al.Characteristics and longer-term outcomes of paravalvular leak after aortic and mitral valve surgery.J Thorac Cardiovasc Surg. 2019; 157: 1785-1792.e1Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar left one-third of patients without operative intervention. Similar to the TAVI literature, PVL was mostly mild (65%, 35% moderate), and there was no evidence for hemolysis. Demographic data were otherwise equivalent to those of the surgical group. Surprisingly, despite the less complex PVL pattern in the conservative group, there was a significant (>10%) worse survival probability at 12 years relative to surgical patients. Importantly, because surgery is always associated with a “mortality investment,” it takes time to “harvest the benefit.” When inspecting the patient survival of Shah and colleauges,7Shah S. Alashi A. Pettersson G.B. Rodriguez L.L. Gillinov A.M. Grimm R.A. et al.Characteristics and longer-term outcomes of paravalvular leak after aortic and mitral valve surgery.J Thorac Cardiovasc Surg. 2019; 157: 1785-1792.e1Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar the curves can be seen to cross, and the benefit of surgery only begins to develop at 2 to 3 years. Because most current TAVI trials have end points defined between 1 and 5 years (PARTNER 3, NCT02675114; DEDICATE, NCT03112980), it is well possible that we miss long-term negative impacts, such as that of only mild PVL, as suggested by Shah and colleagues7Shah S. Alashi A. Pettersson G.B. Rodriguez L.L. Gillinov A.M. Grimm R.A. et al.Characteristics and longer-term outcomes of paravalvular leak after aortic and mitral valve surgery.J Thorac Cardiovasc Surg. 2019; 157: 1785-1792.e1Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar here. Similar mechanisms may apply to long-term sequelae of other end points, such as new pacemakers or valve durability.8De Biase C. Mastrokostopoulos A. Philippart R. Bonfils L. Berthoumieu P. Dumonteil N. What are the remaining limitations of TAVI?.J Cardiovasc Surg (Torino). 2018; 59: 373-380PubMed Google Scholar It thus may be time to blow the whistle on our current evaluation of new valve technology—not to condemn transcatheter technology, but to emphasize the need for longer follow-up in cardiovascular trials including a surgical arm. Shah and colleagues7Shah S. Alashi A. Pettersson G.B. Rodriguez L.L. Gillinov A.M. Grimm R.A. et al.Characteristics and longer-term outcomes of paravalvular leak after aortic and mitral valve surgery.J Thorac Cardiovasc Surg. 2019; 157: 1785-1792.e1Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar present a great base for a randomized trial assessing PVL with their important article. Let us see whether our next steps can be longer. Characteristics and longer-term outcomes of paravalvular leak after aortic and mitral valve surgeryThe Journal of Thoracic and Cardiovascular SurgeryVol. 157Issue 5PreviewParavalvular leak (PVL) is often seen after aortic (AV) and mitral valve (MV) surgery, either due to infection or valve dehiscence. We sought to describe predictors of longer-term outcomes in patients who developed PVL after AV and MV surgery and were considered eligible for reoperative cardiac surgery (RCS). Full-Text PDF Open Archive
OBJECTIVES Aortic valve replacement (AVR) via minimally invasive surgery (MIS) may provide clinical benefits in patients with aortic valve disease. A new class of bioprosthetic valves that enable rapid deployment AVR (RDAVR) may facilitate MIS. We here report the 1-year results of a randomized, multicentre trial comparing the outcomes for MIS-RDAVR with those for conventional AVR via full sternotomy (FS) with a commercially available stented aortic bioprosthesis. METHODS A total of 100 patients with aortic stenosis were enrolled in a prospective, multicentre, randomized comparison trial (CADENCE-MIS). Key exclusion criteria included AVR requiring concomitant procedures, ejection fraction of <25% and recent myocardial infarction or stroke. Patients were randomized to undergo MIS-RDAVR via upper hemisternotomy (EDWARDS INTUITY) or AVR via FS with a commercially available stented valve. Procedural, early and late clinical outcomes were assessed for both groups. Haemodynamic performance was evaluated by an echocardiography CoreLaboratory. RESULTS Technical success was achieved in 94% of MIS-RDAVR patients. MIS-RDAVR was associated with significantly reduced cross-clamp times compared with FS (41.3 ± 20.3 vs 54.0 ± 20.3 min, P < 0.001). Clinical and functional outcomes were similar at 30 days and 1 year postoperatively for both groups. While both groups received a similarly sized implanted valve (22.9 ± 2.1 mm MIS-RDAVR vs 23.0 ± 2.1 mm FS-AVR; P = 0.91), MIS-RDAVR patients had significantly lower peak gradients 1 year postoperatively (16.9 ± 5.3 vs 21.9 ± 8.6 mmHg; P = 0.033) and a trend towards lower mean gradients (9.1 ± 2.9 vs 11.5 ± 4.3 mmHg; P = 0.082). In addition, MIS-RDAVR patients had a significantly larger effective orifice area 1 year postoperatively (1.9 ± 0.5 vs 1.7 ± 0.4 cm2; P = 0.047). Paravalvular leaks, however, were significantly more common in the MIS-RDAVR group (P = 0.027). CONCLUSIONS MIS-RDAVR is associated with a significantly reduced cross-clamp time and better valvular haemodynamic function than FS-AVR. However, paravalvular leak rates are higher with MIS-RDAVR.
Background. Minimally invasive surgical procedures (MIS) may offer several advantages over conventional full sternotomy (FS) aortic valve replacement (AVR). A novel class of aortic valve prostheses has been developed for rapid-deployment AVR (RDAVR). We report a randomized, multicenter trial comparing the outcomes for MIS-RDAVR with those of conventional FS-AVR.Methods. A total of 100 patients with aortic stenosis were enrolled in a prospective, multicenter, randomized comparison trial (CADENCE-MIS). Exclusion criteria included ejection fraction below 25%, AVR requiring concomitant procedures, and recent myocardial infarction or stroke. Patients were randomized to undergo MIS-RDAVR through an upper hemisternotomy (n = 51) or AVR by FS with a conventional stented bioprosthesis (n = 49). Three patients were excluded before the procedure, and 3 more patients who were randomized to undergo RDAVR were excluded because of their anatomy. Procedural, early clinical outcomes, and functional outcomes were assessed for the remaining 94 patients. Hemodynamic performance was assessed by an echocardiography core laboratory.Results. Implanted valve sizes were similar between groups (22.9 +/- 2.1 vs 23.0 +/- 2.1 mm, p =0.9). MIS-RDAVR was associated with significantly reduced aortic cross-clamp times compared with FS-AVR (41.3 +/- 20.3 vs 54.0 +/- 20.3 minutes, p < 0.001), although cardiopulmonary bypass times were similar (68.8 +/- 29.0 vs 74.4 +/- 28.4 minutes, p = 0.21). Early clinical outcomes were similar between the two groups, including quality of life measures. The RDAVR patients had a significantly lower mean transvalvular gradient (8.5 vs 10.3 mm Hg, p = 0.044) and a lower prevalence of patient-prosthesis mismatch (0% vs 15.0%, p = 0.013) 3 months post-operatively compared with the FS-AVR patients.Conclusions. RDAVR by the MIS approach is associated with significantly reduced myocardial ischemic time and better valvular hemodynamic function than FS-AVR with a conventional stented bioprosthesis. Rapid deployment valves may facilitate the performance of MIS-AVR. (C) 2015 by The Society of Thoracic Surgeons
BACKGROUND:Outcome prediction scoring systems are increasingly used in intensive care medicine, but most were not developed for use in cardiac surgery patients. We compared the performance of four intensive care outcome prediction scoring systems (Acute Physiology and Chronic Health Evaluation II [APACHE II], Simplified Acute Physiology Score II [SAPS II], Sequential Organ Failure Assessment [SOFA], and Cardiac Surgery Score [CASUS]) in patients after open heart surgery.METHODS:We prospectively included all consecutive adult patients who underwent open heart surgery and were admitted to the intensive care unit (ICU) between January 1st 2007 and December 31st 2008. Scores were calculated daily from ICU admission until discharge. The outcome measure was ICU mortality. The performance of the four scores was assessed by calibration and discrimination statistics. Derived variables (Mean- and Max- scores) were also evaluated.RESULTS:During the study period, 2801 patients (29.6% female) were included. Mean age was 66.9 ± 10.7 years and the ICU mortality rate was 5.2%. Calibration tests for SOFA and CASUS were reliable throughout (p-value not < 0.05), but there were significant differences between predicted and observed outcome for SAPS II (days 1, 2, 3 and 5) and APACHE II (days 2 and 3). CASUS, and its mean- and maximum-derivatives, discriminated better between survivors and non-survivors than the other scores throughout the study (area under curve ≥ 0.90). In order of best discrimination, CASUS was followed by SOFA, then SAPS II, and finally APACHE II. SAPS II and APACHE II derivatives had discrimination results that were superior to those of the SOFA derivatives.CONCLUSIONS:CASUS and SOFA are reliable ICU mortality risk stratification models for cardiac surgery patients. SAPS II and APACHE II did not perform well in terms of calibration and discrimination statistics.