Carlo Savini

Acute kidney injury following transcatheter aortic valve implantation: incidence, predictors and clinical outcome

BACKGROUND Limited data exist on renal complications of transcatheter aortic valve implantation (TAVI) within a comprehensive program using different valves with transfemoral, transapical, and trans-subclavian approach. METHODS Prospective single-center registry of 102 consecutive patients undergoing TAVI using both approved bioprostheses and different access routes. The main objective was to assess the incidence, predictors and the clinical impact of acute kidney injury (AKI). AKI was defined according to the valve academic research consortium (VARC) indications. RESULTS Mean age was 83.7 ± 5.3 years, logistic EuroSCORE 22.6 ± 12.4%, and STS score 8.2 ± 4.1%. Chronic kidney disease at baseline was present in 87.3%. Periprocedural AKI developed in 42 patients (41.7%): 32.4% stage 1, 4.9% stage 2 and 3.9% stage 3. The incidence of AKI was 66.7% in transapical, 30.3% in transfemoral, and 50% in trans-subclavian procedures. The only independent predictor of AKI was transapical access, with a hazard ratio (HR) between 4.57 and 5.18 based on the model used. Cumulative 1-year survival was 88.2%. At Cox regression analysis, the only independent predictor of 30-day mortality was diabetes mellitus (HR 7.05, 95% CI 1.07-46.32; p=0.042), whilst the independent predictors of 1-year death were baseline glomerular filtration rate<30 mL/min (HR 5.74, 95% CI 1.42-23.26; p=0.014) and post-procedural AKI 3 (HR 8.59, 95% CI 1.61-45.86, p=0.012). CONCLUSIONS TAVI is associated with a high incidence of AKI. Although in the majority of the cases AKI is of mild entity and reversible, AKI 3 holds a strong negative impact on 1-year survival. The incidence of AKI is higher with transapical access.

Complex thoracic aortic disease: Single-stage procedure with the frozen elephant trunk technique

OBJECTIVE Extensive thoracic aortic aneurysms represent a challenging pathology in cardiac surgery. The frozen elephant trunk procedure, combining conventional surgery with endovascular techniques, allows single-stage treatment for such pathology. Here we present our surgical technique and results with the single-stage frozen elephant trunk procedure. METHODS Between January 2007 and December 2009, 67 patients were treated with the frozen elephant trunk procedure in our institution. Mean age was 61 ± 11 years. Indications for surgery included chronic aneurysm (n = 22, 32.8%), acute type A dissection (n = 4, 6.0%), acute type B dissection (n = 2, 3.0%), chronic type A dissection (n = 30, 44.8%), and chronic type B dissection (n = 9, 13.4%). Thirty-six patients (53.7%) had undergone 38 previous cardiac or aortic operations. Thirty-two associated aortic and cardiac operations were performed. Brain protection was achieved by means of antegrade selective cerebral perfusion and moderate hypothermia (26°C) in all cases. RESULTS In-hospital mortality was 13.4%. Postoperatively, permanent neurologic dysfunction (coma) occurred in 5 cases (7.5%), paraplegia in 2 (3.2%), and paraparesis in 3 (4.9%). Follow-up was 100% complete, with mean duration of 11.1 ± 8.4 months. The 1- and 2-year survivals were 76.7 ± 5.6% and 70.3 ± 8.0%, respectively. Ten patients (14.9%) required endovascular completion 2.3 ± 3.1 months after the first procedure, with 100% technical and procedural success. CONCLUSIONS In contrast to the conventional elephant trunk technique, the frozen elephant trunk technique offers a potentially curative single-stage procedure for patients with extensive thoracic aortic disease, with encouraging short-term and midterm results.

Medium Term Outcomes of Transapical Aortic Valve Implantation: Results From the Italian Registry of Trans-Apical Aortic Valve Implantation

BACKGROUND Transcatheter aortic valve implantation (TAVI) has been proposed as a therapeutic option for high-risk or inoperable patients with severe symptomatic aortic valve stenosis. The aim of this multicenter study was to assess early and medium term outcomes of transapical aortic valve implantation (TA-TAVI). METHODS From April 2008 through June 2012, a total of 774 patients were enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). Twenty-one centers were included in the I-TA registry. Outcomes were also analyzed according to the impact of the learning curve (first 50% cases versus second 50% cases of each center) and of the procedural volume (high-volume versus low-volume centers). RESULTS Mean age was 81.0±6.7 years, mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I, EuroSCORE II, and The Society of Thoracic Surgeons risk score were 25.6%±16.3%, 9.4%±11.0%, and 10.6%±8.5%, respectively. Median follow-up was 12 months (range, 1 to 44). Thirty-day mortality was 9.9% (77 patients). Overall 1-, 2-, and 3-year survival was 81.7%±1.5%, 76.1%±1.9%, and 67.6%±3.2%, respectively. Thirty-day mortality of the first 50% patients of each center was higher when compared with the second half (p=0.04) but 3-year survival was not different (p=0.64). Conversely, 30-day mortality at low-volume centers versus high-volume centers was similar (p=0.22). At discharge, peak and mean transprosthetic gradients were 21.0±10.3 mm Hg and 10.2±4.1 mm Hg, respectively. These values remained stable 12 and 24 months after surgery. CONCLUSIONS Transapical TAVI provides good results in terms of early and midterm clinical and hemodynamic outcomes. Thus it appears to be a safe and effective alternative treatment for patients who are inoperable or have high surgical risk.

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.

Endovascular treatment for acute traumatic transection of the descending aorta: Focus on operative timing and left subclavian artery management

OBJECTIVE The operative timing and management of acute traumatic aortic rupture are matters of debate. We reviewed our experience with endovascular repair of acute traumatic aortic rupture, focusing on these topics. METHODS From 1998 to 2007, 31 patients were referred to our institute for acute traumatic rupture of the descending aorta. In 11 patients (group I) an early stent graft procedure was performed, whereas in 16 patients (group II) endovascular repair was delayed. The median time from trauma was 24 hours in group I and 1.5 months in group II. Eight (25.8%) patients had a short proximal neck (<5 mm from the left subclavian artery). Of these, 2 had the left subclavian artery totally covered by the endoprosthesis, and 2 had the left subclavian artery partially covered. Four patients with a posttraumatic pseudoaneurysm involving the left subclavian artery (3 patients) or the left common carotid artery (1 patient) underwent conventional open surgical intervention. RESULTS Technical success was obtained in all patients. There were neither intraoperative nor perioperative deaths. Cerebellar stroke was detected in 1 patient after the intentional closure of the left subclavian artery. Follow-up (32.7 +/- 27.5 months) was 100% complete. No late deaths, endoleaks, or complications occurred. CONCLUSION The endovascular approach was a safe and flexible procedure in traumatic aortic rupture and allowed us to fit the operative timing to every patients clinical and imaging findings. In the presence of an inadequate proximal landing zone, conventional open surgical intervention still remains a favorable option as an alternative to endovascular procedures if a surgical revascularization of the left subclavian artery, carotid artery, or both is necessary.

Short- and midterm results after hybrid treatment of chronic aortic dissection with the frozen elephant trunk technique

OBJECTIVE The purpose of this study was to examine our experience with the frozen elephant trunk in patients with chronic aortic dissection. METHODS In our Institution, between January 2007 and August 2010, 49 patients (mean age: 59.6 ± 9.0 years) underwent total arch replacement with the frozen elephant trunk technique for chronic aortic dissection (type A, n=2; residual type A, n=37; type B, n=10). Forty patients (81.6%) patients had undergone previous cardiovascular procedures. Associated cardiac procedures were indicated in 21 (42.8%) patients. Brain protection was achieved with antegrade selective cerebral perfusion in all cases. RESULTS Hospital mortality (n=5) was 10.2%. Postoperative serious complications included coma (n=3; 6.1%), paraplegia (n=2; 4.1%), respiratory failure (n=6; 12.2%), and definitive dialysis (n=2; 4.1%). Follow-up was 100% completed (mean period: 12.9 ± 11.7 months). The estimated 1- and 3-year survival rates were 91.2 ± 4.2% and 81.6 ± 6.5%, respectively. Endovascular extension was required in 11 (22.4%) patients, with technical success of 100%. Complete thrombosis of the peri-stent false lumen was achieved in 82.9% of cases, with significant reduction of the false lumen diameter (preoperative: 36 ± 11 mm; postoperative: 24 ± 17 mm; p=0.001) and increase of the true lumen diameter (preoperative: 15 ± 5 mm; postoperative: 26 ± 6 mm; p=0.001). CONCLUSIONS The frozen elephant trunk technique, allowing treatment of extensive disease of the thoracic aorta, was associated with encouraging short- and midterm results. Longer-term follow-up is warranted.

Trans-subclavian versus transapical access for transcatheter aortic valve implantation: A multicenter study

To compare the outcomes of trans‐subclavian (TS) and transapical (TA) access for transcatheter aortic valve implantation (TAVI).

Myocardial protection using HTK solution in minimally invasive mitral valve surgery.

BACKGROUND Minimally invasive cardiac surgery (MICS) is a safe and satisfactory approach used mainly in mitral valve surgery with excellent results in many centers. Cardioplegia administration can be still a problem, especially when an endoaortic clamp is used. We retrospectively analyzed our early results with histidine-triptophane-ketoglutarate (HTK) solution used for myocardial protection in MICS. METHODS Between February 2003 and February 2004, 8 patients underwent mitral valve surgery using an endo- cardiopulmonary bypass (CPB) system and HTK solution as myocardial protection. The mean patient age was 67.7 +/- 9.2 years, and the preoperative ejection fraction was normal in all patients. Three patients had valve repair and 5 had valve replacement. Mean CPB time was 129.2 +/- 19.4 minutes, and aortic cross-clamp duration was 88.5 +/- 15.4 minutes. RESULTS In every case HTK solution was used for only a single dose for cardioplegia at the beginning of the procedure, without any recalls. The heart restarted spontaneously at reperfusion in 6 of 8 cases (75%), and there were no significant modifications in electrocardiogram results or myocardial cytonecrosis enzymes (creatine kinase and its MB fraction) during the postoperative period. CONCLUSIONS HTK solution is a cold crystalloid cardioplegia solution that has demonstrated its utility in MICS because it provides a safe long cardioplegic arrest time and it reduces the risk of inadequate coronary perfusion due to dislodgement of the endoaortic clamp.

Cerebral protection during surgery of the aortic arch

Brain injury represents a primary concern during aortic arch surgery. Valid surgical techniques and reliable methods of brain protection are required to obtain a favorable outcome after such a complex surgery. Our aim was to review available methods of brain protection including deep hypothermia and circulatory arrest, retrograde cerebral perfusion and antegrade cerebral perfusion.

When does transapical aortic valve replacement become a futile procedure? An analysis from a national registry

OBJECTIVES Patient selection is crucial to achieve good outcomes and to avoid futile procedures in patients undergoing transcatheter aortic valve replacement. The aim of this multicenter retrospective study was to identify independent predictors of 1-year mortality in patients surviving after transapical transcatheter aortic valve replacement. METHODS We analyzed data from the Italian registry of transapical transcatheter aortic valve replacement that includes patients undergoing operation in 21 centers from 2007 to 2012. Futility was defined as mortality within 1 year after transapical transcatheter aortic valve replacement in patients surviving at 30 days. Thirty-day survivors were divided in 2 groups: futility (group F) and nonfutility (group NF). Cox proportional hazard regression analysis was performed to identify independent predictors of futility. RESULTS We analyzed data from 645 patients with survival of 30 days or more after transapical transcatheter aortic valve replacement. Groups F and NF included 60 patients (10.8%) and 585 patients (89.2%), respectively. Patients in group F were more likely to have insulin-dependent diabetes (15% vs 7.2%, P = .03), creatinine 2.0 mg/dL or greater or dialysis (18.3% vs 8.2%, P = .01), logistic European System for Cardiac Operative Risk Evaluation greater than 20% (66.7% vs 50.3%, P = .02), preoperative rhythm disorders (40% vs 25.3%, P = .03), critical preoperative state (8.3% vs 1.8%, P = .002), and left ventricular ejection fraction less than 30% (15% vs 2.9%, P < .001). The multivariate analysis identified the following as independent predictors of futility: insulin-dependent diabetes (odds ratio, 3.1; P = .003), creatinine 2.0 mg/dL or greater or dialysis (odds ratio, 2.52; P = .012), preoperative rhythm disorders (odds ratio, 1.88; P = .04), and left ventricular ejection fraction less than 30% (odds ratio, 4.34; P = .001). CONCLUSIONS According to our data, among patients undergoing transapical transcatheter aortic valve replacement, those with insulin-dependent diabetes, advanced chronic kidney disease, rhythm disorders, and low left ventricular ejection fraction have a higher risk to undergo futile procedures.