Marco Aiello

Clinical and hemodynamic outcomes of ''all-comers'' undergoing transapical aortic valve implantation: Results from the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA)

OBJECTIVE The aim of this study was to assess clinical and hemodynamic outcomes of transapical aortic valve implantation (TA-TAVI) in patients enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). METHODS From April 2008 until November 2010, 504 patients from 20 Italian centers were enrolled in the I-TA registry. Mean logistic EuroSCORE and Society of Thoracic Surgeons score were 24% ± 16% and 11% ± 4%, respectively. Mean follow-up was 9.2 ± 6.5 months (range, 1-26 months). Outcomes were analyzed according to intraoperative complications, procedural volume (high-volume centers, >20 cases; low-volume centers, < 20 cases) and learning curve (first 50% cases vs second 50% cases of each center). RESULTS All-cause overall mortality was 8.3% (42 patients). Device success was 99% (500/504 patients). Intraoperative severe complications occurred in 24 (4.8%) patients. Overall 2-year survival was 71.5% ± 6.2%. At discharge, peak and mean gradients were 16.4 ± 11.2 and 8.7 ± 4.1 mm Hg, respectively, and effective orifice area was 1.67 cm(2). These values remained stable at 3, 6, and 12 months after surgery. Independent risk factors for mortality after TA-TAVI were as follows: New York Heart Association class III and IV (odds ratio [OR], 4.43; 95% confidence intervals [CI], 1.28-15.40; P = .02); logistic EuroSCORE greater than 20 (OR, 1.83; 95% CI, 1.02-3.29; P = .04); creatinine concentration greater than 200 μmol/L (OR, 2.56; 95% CI, 1.07-6.15; P = .03), and intraoperative complications (OR, 5.80; 95% CI, 2.68-12.55; P < .001). There were no significant differences in outcomes between high- and low-volume centers and between the first and the second 50% of cases. CONCLUSIONS TA-TAVI represents a safe and effective alternative treatment for patients who are inoperable or at high risk for surgery. The occurrence of an intraoperative complication significantly affects survival. Procedural volume and learning curve have no impact on patient survival.

Neoplastic disease after heart transplantation: single center experience

OBJECTIVES Mandatory use of prolonged immunosuppression in organ transplantation is complicated by an increased incidence of cancer. The current study represents a retrospective analysis of the incidence of neoplasms in our heart transplantation program. METHODS Four-hundred and seventy-four patients (403 male and 71 female; mean age, 48.6+/-12.1 years), with at least 30 days of follow-up, were enrolled in this study. Patients received triple immunosuppression with cyclosporin A, azathioprine and steroids. Moreover, as a prophylactic anti-lymphocyte therapy, 388 patients (82%) were administered RATG, 67 patients (14%) received ALG and 19 patients (4%) OKT3. The mean follow-up time was 71.1+/-43.0 months. RESULTS Fifty-five patients (11.6%) developed malignant neoplasms. The cancer frequencies were: solid tumors, 55%; non-Hodgkin lymphomas (NHL), 20%; Kaposis sarcomas, 11%; skin cancers, 9%; undifferentiated sarcomas and myelomas, 5%. Solid tumors mainly affected the lung (39%), bowel (16%), stomach (6.5%), liver (6.5%), pancreas (6.5%) and oral cavity (6.5%). The times to the onset of cancer from transplantation were: Kaposis sarcoma, 12.7+/-16.8 months; skin cancers, 34.5+/-23.8 months; solid tumors, 54.3+/-38.7 months; NHL, 60.1+/-36.4 months; undifferentiated sarcomas and myelomas, 90.0+/-15.6 months. As determined by univariate and multivariate analyses, sex, number of treated rejections, previous history of tumor, average dose of cyclosporine and prednisone and cyclosporine blood levels did not increase the incidence of malignancies. Univariate analysis suggests a significant correlation between the type of prophylactic immunoglobulins and the average dose of azathioprine with the incidence of neoplasms. Both univariate and multivariate analyses demonstrated a significant correlation between patients age at the time of transplantation and risk of cancer occurrence (risk increased by 1.074/year; P=0.0056 with multivariate Cox regression). CONCLUSIONS Cancer is a strong limitation for long-term survival after heart transplantation. The only risk factor recognized is the patients age at the time of transplant. Furthermore, the type of prophylactic globulins used for induction therapy and some specific immunosuppressant agent (azathioprine) may play a significant role in the development of malignancies after transplantation.

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.

Port-access minimally invasive surgery for atrial septal defects: A 10-year single-center experience in 166 patients

OBJECTIVE We assessed the surgical results and the benefits to the patient of a minimally invasive surgical approach for atrial septal defects. METHODS Between May 1998 and May 2008, 166 patients (median age, 44 years) had surgery for atrial septal defects in our institution. Of these patients, 118 (71%) had a patent foramen ovale (associated with atrial septal aneurysm in 48 cases), 33 (20%) had a wide ostium secundum defect, 6 (3.6%) had an ostium primum defect, 6 (3.6%) had a sinus venosus defect with abnormal pulmonary vein connection, and 1 (0.6%) had a coronary sinus defect. In 2 cases (1.2%) patients were referred to our department for surgical correction after failure of interventional occluder placement. All patients were operated on via a right minithoracotomy (mean incision, 5.5 + or - 1 cm) in the fourth intercostal space and under cardiopulmonary bypass. RESULTS The HeartPort access system was used in 106 patients (64%), with an endoaortic clamp (central kit in 50 cases and peripheral kit in 56). In the remaining patients (36%), we preferred the Portaclamp system (37 cases) or the Chitwood clamp (23 cases). Average crossclamp time was 38.4 + or - 22.2 minutes with a mean cardiopulmonary bypass time of 64.9 + or - 34.5 minutes. There was no conversion in classic sternotomy. There were no early or late hospital deaths. Surgical revision was performed in 6 patients for bleeding from the thoracic wall. The mean hospital stay was 5.8 days. At 51 months mean follow-up, 4 patients died of non-cardiac-related causes. CONCLUSIONS Port-access minimally invasive surgery for atrial septal defects is a safe, less-invasive, reproducible, and cosmetic operation, providing an excellent outcome and an effective correction, and could be now considered the standard approach for this type of patient.

Port-access surgery as elective approach for mitral valve operation in re-do procedures

BACKGROUND Re-do mitral valve procedures performed through median sternotomy carry substantial mortality and morbidity. To avoid complications of sternal re-entry and to provide adequate mitral valve exposure, antero-lateral thoracotomy has been suggested by some authors. METHODS From October 1997 to January 2007, 677 mitral valve operations have been performed in our centre using port-access video-assisted right mini-thoracotomy. Among these, 241 (35.6%) were performed on patients who had undergone one or more previous cardiac surgery procedures. RESULTS Mean cardio-pulmonary bypass time and endo-clamp time were 117+/-46 min and 71+/-31 min, respectively. Arterial cannulation was performed either on the ascending aorta, with the endo-direct cannula (112 patients, 46.5%), or peripherally with a femoral artery approach (129 patients, 53.5%). Conversion to median sternotomy was necessary in only two patients (0.8%) due to aortic dissection (one case) and left ventricle free wall rupture (one case). Median intensive care unit stay was 24h, median mechanical ventilation time was 12h; median hospital stay was 8 days. Bleeding requiring surgical revision occurred in 12 patients (4.9%). Hospital mortality was 4.9% (12/241 patients). CONCLUSIONS Port-access video-assisted right mini-thoracotomy allows good results in a difficult subset of patients; it allows minimal adhesion dissection, short ICU and hospital stay. In our practice, this technique has become the treatment of choice for mitral valve re-do surgery.

Clodronate treatment of established bone loss in cardiac recipients: a randomized study.

Background. Bone loss has been reported as a complication after heart transplantation (HTx), and the increase in bone fractures is an effective problem. Treatment of osteoporosis has obtained mixed results. In this study we evaluate the effect of treatment with an oral bisphosphonate. Methods. Sixty-four patients with low mineral density 6 months after HTx were randomized as follows: Group A received oral clodronate (1600 mg/day in two divided doses), and Group B received placebo. Every patient was also treated with 2000 mg/day of oral calcium carbonate. Bone mineral density (BMD) was measured by dual energy x-ray absorptiometry at the lumbar spine, 1/3 and 1/10 of the distal nondominant forearm before and after 12 months of treatment. Laboratory tests were performed at 3, 6, and 12 months of treatment. Results. All patients demonstrated manifest bone loss 6 months after HTx compared with normal non-HTx controls (P =0.0001). After 1 year of clodronate therapy, BMD at the lumbar spine increased from 0.77±1.4 g/cm2 to 0.86 g/cm2 (P =0.02). Laboratory tests did not show any significant variation, except for the bone isoenzyme of alkaline phosphatase, which showed a significant decrease after 1 year of treatment. The incidence of new fractures was 9.3% in the placebo group and 0% in the clodronate group. Therapy was well tolerated without impact on graft function. Conclusions. One year of clodronate therapy induced a significant increase in BMD at the lumbar spine in our HTx patients. Treatment was well tolerated without onset of new bone fractures.

Transcatheter Aortic Valve Replacement Using Transaortic Access: Experience From the Multicenter, Multinational, Prospective ROUTE Registry

OBJECTIVES The Registry of the Utilization of the TAo-TAVR approach using the Edwards SAPIEN Valve (ROUTE) was established to assess the effectiveness and safety of the use of transaortic (TAo) access for transcatheter aortic valve replacement (TAVR) procedures (NCT01991431). BACKGROUND TAVR represents an alternative to surgical valve replacement in high-risk patients. Whereas the transfemoral access route is used commonly as the first-line approach, transapical access is an option for patients not suitable for transfemoral treatment mainly due to anatomic conditions. TAo-TAVR has been shown to be a viable alternative surgical access route; however, only limited data on its effectiveness and safety has been published. METHODS ROUTE is a multicenter, international, prospective, observational registry; data were collected from 18 centers across Europe starting in February 2013. Patients having severe calcific aortic stenosis were documented if they were scheduled to undergo TAo-TAVR using an Edwards SAPIEN XT or a SAPIEN 3 valve. The primary endpoint was 30-day mortality. Secondary endpoints were intraprocedural or in hospital and 30-day complication rates. RESULTS A total of 301 patients with a mean age of 81.7 ± 5.9 years and an Society of Thoracic Surgeons score of 9.0 ± 7.6% were included. Valve success was documented in 96.7%. The 30-day mortality was 6.1% (18/293) (procedure-related mortality: 3.1%; 9 of 293). The Valve Academic Research Consortium-2 defined complications included myocardial infarction (1.0%), stroke (1.0%), transient ischemic attack (0.3%), major vascular complications (3.4%), life-threatening bleeding (3.4%), and acute kidney injury (9.5%). In 3.3% of patients, paravalvular regurgitation was classified as moderate or severe (10 of 300). Twenty-six patients (8.8%) required permanent pacemaker implantation. CONCLUSIONS TAo access for TAVR seems to be a safe alternative to the transapical procedure.

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.

Directional coronary atherectomy plus stent implantation vs. left internal mammary artery bypass grafting for isolated proximal stenosis of the left anterior descending coronary artery

The aim of this study was to compare the short‐ (< 30 days) and long‐term (≥ 30 days) clinical outcomes of left internal mammary artery bypass grafting (LIMA‐LAD) and directional coronary atherectomy plus stent implantation (DCA + stent) in the treatment of isolated proximal left anterior descending coronary (LAD) lesions. One hundred and twenty‐six patients underwent LIMA‐LAD and 132 consecutive patients underwent DCA + stenting. The primary endpoint was the incidence of short‐ and long‐term major adverse cardiac events (MACE); the secondary endpoints included any periprocedural events and long‐term target vessel revascularization (TVR). We found no significant between‐treatment difference in the occurrence of short‐term MACE, and the long‐term MACE rate per 100 person‐years was 3.0 in the LIMA‐LAD group and 4.6 in the DCA + stent group. After 5‐year follow‐up, 79% of the patients in the DCA + stent group and 89% of those in the LIMA‐LAD group were still MACE‐free. The risk of any periprocedural events was six times lower in the DCA + stent group, and the risk of TVR was six times higher. We conclude that both procedures lead to good short‐ and long‐term follow‐up results in isolated proximal LAD disease. As fewer periprocedural events and more TVRs occur after DCA + stenting than after LIMA‐LAD, they can be considered valuable alternatives to each other. Catheter Cardiovasc Interv 2005;64:45–52.

Minimally invasive video-assisted cardiac surgery: operative techniques, application fields and clinical outcomes.

Minimally invasive video-assisted surgery through a right minithoracotomy has become the standard surgical approach for several cardiac diseases at many major centers worldwide. In this article we review the existing literature on the subject and describe different operative techniques, application fields and clinical outcomes.