Lorenzo Di Bacco

Treating the patients in the ‘grey-zone’ with aortic valve disease: a comparison among conventional surgery, sutureless valves and transcatheter aortic valve replacement

OBJECTIVES Although the use of transcatheter aortic valve replacement (TAVR) has recently become an attractive strategy in extremely high-risk patients undergoing aortic valve replacement (AVR), the most appropriate treatment option in patients with an intermediate- to high-risk profile with conventional surgery (sAVR), TAVR or novel options, such as sutureless valves, has been widely debated. METHODS One hundred and sixty-three consecutive patients with intermediate to high risk were prospectively enrolled and selected to undergo sAVR (Group 1: G1, n = 55), sutureless valve implantation (Group 2: G2, n = 53) or TAVR (Group 3: G3, n = 55) following a multidisciplinary evaluation including frailty, anatomy and degree of atherosclerotic disease of the aorta/peripheral vessels. The mean logistic EuroSCORE (G1 = 21.3 ± 12.7 vs G2 = 16 ± 11.7 vs G3 = 20.4 ± 12.7, P = 0.06) and preoperative demographics, such as age, gender and left ventricular ejection fraction, were similar: of note, chronic obstructive pulmonary disease was more frequent in TAVI patients (G1 = 27.2% vs G2 = 15.1% vs G3 = 47%; P <0.01). The Perceval S sutureless valve was used in Group 2, whereas TAVR was performed with a Corevalve prosthesis. RESULTS Post-procedural pacemaker implantation (G1 = 1.8% vs G2 = 2% vs G3 = 25.5%, P <0.001) and peripheral vascular complications (G1 = 0% vs G2 = 0% vs G3 = 14.5%, P <0.001) occurred more frequently in patients undergoing TAVR. Hospital mortality was similar among the groups (G1 = 0% vs G2 = 0% vs G3 = 1.8%, P = NS). At the 24-month follow-up, overall survival free from major adverse cardiac and cerebrovascular events and prosthetic regurgitation was better in patients who had undergone sAVR and sutureless valves than those who had undergone TAVR (G1 = 95.2 ± 3.3% vs G2 = 91.6 ± 3.8% vs G3 = 70.5 ± 7.6%; P = 0.015). CONCLUSIONS This preliminary study suggests that the use of TAVR in patients with an intermediate- to high-risk profile is associated with a higher rate of perioperative complications and decreased survival at the 24-month follow-up compared with the use of conventional surgery or sutureless valves.

Hybrid revascularization in multivessel coronary artery disease

OBJECTIVES Minimally invasive hybrid revascularization (MIHR) by means of the left mammary artery on the left anterior descending artery [minimally invasive direct coronary artery bypass (MIDCAB)] combined with percutaneous coronary interventions (PCI) stenting may be an alternative to conventional coronary artery bypass grafting through sternotomy or multiple PCI. The purpose of this study is to retrospectively evaluate the long-term outcomes of this strategy. METHODS Since May 1997 up to January 2011, 810 MIDCAB have been performed as isolated revascularization in 644 patients. Since 2004, MIDCAB, as a part of hybrid revascularization, was associated with PCI in 166 patients. RESULTS In the MIDCAB group, mean age was 64.6 ± 12.0, with 83.8% males. Two-vessel disease was 62.4%, three-vessel disease 37.6%. Overall mortality was 0.24%, perioperative acute myocardial infarction-1.6%, early reoperation-0.74%, reopening for bleeding-1.2%, case rate of haemotrasfusion-3.1%, with a mean hospital postoperative stay of 4 ± 2.5 days. Postoperative angiographic control prior to PCI and in symptomatic patients showed patent left internal mammary artery in 100% of cases. PCI was performed in 166 patients, 64.2% before MIDCAB and 35.8% after surgery (interval 2.2 ± 1.3 months). The mean follow-up in the MIDCAB group was 8.4 ± 3.2 years. In the MIHR group, at the mean follow-up of 4.5 ± 2.3 years, freedom from related cardiac death was 93% with freedom from cardiac reintervention of 83%. CONCLUSIONS Our 13-year experience with MIDCAB demonstrates that the operation is safe and associated with a very low incidence of early and late complications. The hybrid approach provided excellent long-term outcome in terms of freedom from cardiac death and reoperation. Accurate patient selection, as well the timing of the hybrid procedure, is mandatory to optimize surgical and PCI results.

A comparison of conventional surgery, transcatheter aortic valve replacement, and sutureless valves in “real-world” patients with aortic stenosis and intermediate- to high-risk profile

OBJECTIVE We sought to investigate the clinical outcomes of patients with isolated severe aortic stenosis and an intermediate- to high-risk profile treated by means of conventional surgery (surgical aortic valve replacement), sutureless valve implantation, or transcatheter aortic valve replacement in a multicenter evaluation. METHODS Among 991 consecutive patients with isolated severe aortic stenosis and an intermediate- to high-risk profile (Society of Thoracic Surgeons score >4 and logistic European System for Cardiac Operative Risk Evaluation I >10), a propensity score analysis was performed on the basis of the therapeutic strategy: surgical aortic valve replacement (n = 204), sutureless valve implantation (n = 204), and transcatheter aortic valve replacement (n = 204). Primary end points were 30-day mortality and overall survival at 24-month follow-up; the secondary end point was survival free from a composite end point of major adverse cardiac events (defined as cardiac-related mortality, myocardial infarction, cerebrovascular accidents, and major hemorrhagic events) and periprosthetic regurgitation greater than 2. RESULTS Thirty-day mortality was significantly higher in the transcatheter aortic valve replacement group (surgical aortic valve replacement = 3.4% vs sutureless = 5.8% vs transcatheter aortic valve replacement = 9.8%; P = .005). The incidence of postprocedural was 3.9% in asurgical aortic valve replacement vs 9.8% in sutureless vs 14.7% in transcatheter aortic valve replacement (P< .001) and peripheral vascular complications occurred in 0% of surgicalaortic valve replacement vs 0% of sutureless vs 9.8% transcatheter aortic valve replacement (P< .001). At 24-month follow-up, overall survival (surgical aortic valve replacement = 91.3% ± 2.4% vs sutureless = 94.9% ± 2.1% vs transcatheter aortic valve replacement = 79.5% ± 4.3%; P < .001) and survival free from the composite end point of major adverse cardiovascular events and periprosthetic regurgitation were significantly better in patients undergoing surgical aortic valve replacement and sutureless valve implantation than in patients undergoing transcatheter aortic valve replacement (surgical aortic valve replacement = 92.6% ± 2.3% vs sutureless = 96% ± 1.8% vs transcatheter aortic valve replacement = 77.1% ± 4.2%; P < .001). Multivariate Cox regression analysis identified transcatheter aortic valve replacement as an independent risk factor for overall mortality hazard ratio (hazard ratio, 2.5; confidence interval, 1.1-4.2; P = .018). CONCLUSIONS The use of transcatheter aortic valve replacement in patients with an intermediate- to high-risk profile was associated with a significantly higher incidence of perioperative complications and decreased survival at short- and mid-term when compared with conventional surgery and sutureless valve implantation.

Early hemodynamics and clinical outcomes of isolated aortic valve replacement with stentless or transcatheter valve in intermediate-risk patients

Objective: Stentless aortic valves have been developed to overcome obstructive limitations associated with stented bioprostheses. The aim of the current multi‐institutional study was to compare hemodynamics of transcatheter (TAVR) and the Freedom SOLO Stentless (FS) valve in an intermediate risk population undergoing surgical aortic valve replacement. Methods: From 2010 to 2014, 420 consecutive patients underwent isolated surgical aortic valve replacement with FS and 375 patients underwent TAVR. Only patients with intermediate operative risk (Society of Thoracic Surgeons score 4‐10) and small aortic annulus (≤23 mm) were included. After a propensity matched analysis 142 patients in each group were selected. Thirty‐day postoperative clinical and echocardiographic parameters were evaluated. Results: Mean prosthesis diameter was 22.2 ± 0.9 mm for FS and 22.4 ± 1.0 mm for TAVR. In‐hospital mortality was 2.1% for FS and 6.3% for TAVR (P = .02). Postoperative FS peak gradients were 19.1 ± 9.6 mm Hg (mean 10.8 ± 5.9 mm Hg); TAVR peak gradients were 20.2 ± 9.5 mm Hg (mean 10.7 ± 6.9 mm Hg) P = .57 (P = .88). Postoperative effective orifice area was 1.93 ± 0.52 cm2 for FS and 1.83 ± 0.3 cm2 for TAVR (P = .65). There was no prostheses‐patient mismatch in either group. Postoperative grade 2‐3 paravalvular leak was present in 3.5% for TAVR and 0.7% for FS. Postoperative permanent pacemaker implant rate was 12% for TAVR and only 1 case (0.7%) in the FS group (P < .001). Conclusions: In patients with small aortic annulus and intermediate risk, both FS and TAVR demonstrated similar excellent hemodynamic performance. TAVR demonstrated greater mortality and rates of pacemaker insertion. Further studies are warranted to validate TAVR indications in this subset of patients.

Hybrid Coronary Revascularization in 100 Patients With Multivessel Coronary Disease

BACKGROUND Hybrid coronary revascularization, meaning, left mammary artery on left anterior descending artery combined with non-left anterior descending artery percutaneous coronary intervention stenting, is considered a viable alternative to conventional coronary artery bypass graft surgery or to multivessel percutaneous coronary intervention, to perform a functionally complete revascularization. METHODS One hundred consecutive patients underwent hybrid coronary revascularization. Coronary risk was assessed by the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) score. Long-term outcomes, major adverse cardiac and cerebrovascular events (MACCE) rate, and repeated target vessels revascularization (TVR) rate were evaluated. RESULTS Mean age was 66.3±12.0 years. Mean SYNTAX score was 28.22±7. Mean European System for Cardiac Operative Risk Evaluation II score was 4.05±1.83. Percutaneous coronary intervention was performed in all patients (n=100), in 75% of cases before and in 25% of cases after surgery (interval, 2.2±1.3 months). No in-hospital mortality was reported. At follow-up, 1 cardiac death of acute MI occurred. At 3.5±1.3 years follow-up, overall population freedom from MACCE rate was 82.6% (95% confidence interval [CI]: 79.5% to 85.7%) and the freedom from TVR rate was 86.1% (95% CI: 82.9% to 89.3%). MACCE and TVR rates were higher in patients with intermediate and high coronary risk than in patients with SYNTAX score of 22 or less, although not statistically significant (p>0.05). Cox regression analysis showed a significant increment of risk for TVR on overall population in patients with diabetes mellitus (OR 2.4, 95% CI 1.3-3.5, p=0.03) and in patients with non-left anterior descending artery stented lesions (OR 4.5, with 95% CI 2.8-6.2, p=0.02). CONCLUSIONS Hybrid coronary revascularization is a viable option to perform a minimally invasive, functionally complete revascularization in high-risk patients for conventional revascularization, with better results when performed on patients with a SYNTAX score of 22 or less.

European prospective multicentre study of hybrid thoracoscopic and transcatheter ablation of persistent atrial fibrillation: the HISTORIC-AF trial

OBJECTIVES The HISTORIC‐AF trial is a prospective, multicentre, single‐arm study designed to evaluate the outcomes of a staged endoscopic and transcatheter ablation in patients with stand‐alone, persistent or long‐standing persistent atrial fibrillation (AF). METHODS From 2012 to 2015, 100 consecutive patients were enrolled and underwent thoracoscopic left atrial epicardial isolation (‘box lesion’) followed by transcatheter ablation in case of AF recurrency. The safety end point was the composite outcome of freedom from major adverse events at 30‐days, while efficacy end points were: (i) primary: freedom from AF and stable sinus rhythm following isolated thoracospic ablation >60% and (ii) secondary: freedom from AF and stable sinus rhythm >80% following hybrid ablation (as per HRS criteria). RESULTS No death occurred and surgical thoracoscopic procedure was successfully completed in all patients. Survival free from major adverse events at 30 days was 94%: there were 3 permanent pacemaker implants, 2 episodes of stroke and 1 revision for bleeding. At discharge, 87% of patients were in sinus rhythm. A staged transcatheter ablation was carried out in all patients with AF recurrences at the end of 3 months blanking period (17% of patients). At 12‐months follow‐up, a stable restoration of sinus rhythm was achieved in 75% and 88% of patients following isolated thoracoscopic ablation and hybrid ablation, respectively. CONCLUSIONS The HISTORIC‐AF trial showed that thoracoscopic isolated surgical ablation reached both the safety and the efficacy end points. Hybrid ablation steadily improved rhythm outcomes and may be considered in the future as the treatment of choice for patients with persistent and long‐standing persistent AF. ClinicalTrials.gov Identifier NCT01622907.

Is the Freedom SOLO Stentless Bioprosthesis a Useful Tool for Patients with Aortic Endocarditis and Aortic Annular Destruction

BACKGROUND  The Freedom SOLO (FS) stentless bovine-pericardial prosthesis with a supra-annular implantation technique can be a viable option for patients with endocarditic annular destruction. We assessed early- and long-term outcomes following the use of this prosthesis in extensive aortic valve endocarditis. METHODS  From 2006 to 2016, 59 patients with extensive aortic endocarditis underwent aortic valve replacement (AVR) with FS (cumulative follow-up 263 patients-years) in three European centers; all patients presented annular tissue infection, while 54.3% of patients had annular abscess. RESULTS  Mean age was 66 ± 11 years and mean EuroSCORE I was 30.3% (standard deviation: 24.1%). In our series, 30.5% of patients had prosthetic valve endocarditis. Early mortality was 15.2% (nine patients). Estimated overall survival at 5 and 10 years was 68.9% (95% confidence interval [CI]: 62.8-75.0%) and 59.1% (95% CI: 66.8-81.2%), respectively. At 10-year survival, freedom from valve-related death was 83.7% (95% CI: 80.9-86.5%). No structural valve deterioration was reported in this series. Five patients (8.5%) had recurrent endocarditis during follow-up and two of them underwent reoperation. Survival freedom from reoperation and endocarditis at 10-year follow-up was 88.0% (CI: 80.4-95.6%) and 86.7% (CI: 80.5-92.9%), respectively. CONCLUSION  FS stentless bioprosthesis is a valuable and simple option to achieve AVR in patients with extensive aortic annulus endocarditis. Although in this group of complex patients, early mortality remains considerably high, late survival outcomes are comparable to the more technically demanding homografts and conventional stentless bioprostheses, with low rates of endocarditis recurrence.

Long term follow-up of total arterial versus conventional and hybrid myocardial revascularization: A propensity score matched analysis

PURPOSE To evaluate the impact of the revascularization technique (by means of conventional, total arterial or hybrid myocardial revascularization) in patients with multivessel coronary artery disease. METHODS A propensity-score analysis of patients undergoing myocardial revascularization from 1998 to 2012 was performed based on the surgical technique utilized, either total arterial (Group1, G1,n° = 89), conventional CABG(LIMA on LAD plus veins, Group2, G2,n° = 89), or hybrid revascularization (LIMA on LAD plus PTCA on non-LAD vessels, Group3, G3, n° = 89). Primary end-points were overall survival and cardiac-related death while secondary composite end-point was survival freedom from major adverse cardiac and cerebrovascular events (MACCEs) defined as myocardial infarction, cardiac death, stroke and repeated target vessel revascularization. RESULTS Study population was mostly affected by double-vessels disease (G1 = 2.35 vs G2 = 2.3 vs G3 = 2.4, p = 0.14) with a preserved LV function(G1 = 48% vs G2 = 49% vs G3 = 50%, p = 0.12). Hospital mortality was 0% in all groups. At a mean follow-up of 6 ± 2 years overall survival was significantly better in patients receiving total arterial myocardial revascularization (G1 = 90.4 ± 3.5% vs G2 = 82.3 ± 4.2% vs G3 = 82.1 ± 5.9%, p = 0.049) as well as freedom from MACCEs (G1 = 95.2 ± 2.4% vs G2 = 86.5 ± 4% vs G3 = 68 ± 6.9%, p = 0.001) while survival free from cardiac-related death was similar(G1 = 97.7 ± 1.6% vs G2 = 95.1 ± 2.4% vs G3 = 89.5 ± 5.4%, p = 0.08). Conversely, at 10 years follow-up only freedom from MACCEs was significantly better in patients of Group 1(G1 = 78.9 ± 8.6% vs G2 = 72.4 ± 5.7% vs G3 = 52 ± 8.7%, p < 0.001). CONCLUSIONS Total arterial revascularization provides improved outcomes at mid and long term follow-up compared with conventional or hybrid revascularization. The latter technique is particularly associated with a significantly higher incidence of late myocardial infarction and repeat revascularization.

Rapid Explantation of Rapid-Deployment Sutureless Valve in Case of Acute Endocarditis: How to Remove Safely Sutureless Perceval S Prostheses

We report a case of infective endocarditis on a Perceval S aortic valve bioprosthesis, and we describe a feasible and useful technique that can help remove the infected valve. These maneuvers consist of an “x-movement” reached with the aid of anatomical forceps. The risk of infective endocarditis in patients with prosthetic valves is a well-known phenomena in cardiac surgery, and it can represent a life-threatening event in many cases. According to guidelines, an emergency surgical intervention is required in case of high risk of embolization, vegetation superior than 1 cm or acute cardiac failure secondary to the acute valve dysfunction. In the reported case, the patient was submitted to emergency surgery because of vegetation with diameter superior to 1 cm on the aortic bioprosthesis. The described “x-movement” technique allowed an easily “en block” excision of the damaged bio-prostheses together with vegetation, minimizing the risk of vegetation fragmentation.