A comparison of the femoral and radial crossover techniques for vascular access management in transcatheter aortic valve implantation: the Milan experience.

OBJECTIVE: To compare radial and femoral crossover techniques (CT) for vascular access management in transcatheter aortic valve implantation (TAVI). BACKGROUND: Femoral crossover for controlled angiography and balloon inflation of the therapeutic access site to facilitate safe vascular closure is beneficial but technically challenging in patients with complex femoral anatomy. An alternative approach should be available. METHODS: Between June 2011 and March 2012, 41 transfemoral TAVI patients receiving the femoral CT were compared to 46 transfemoral TAVI patients receiving the radial CT. Outcomes were 30-day valve academic research consortium (VARC) endpoints. RESULTS: Patients undergoing the radial CT received higher median contrast volumes (150 interquartile range [IQR]: 105-180 vs. 111 IQR: 90-139 ml; P = 0.025) but procedural radiation dose and fluoroscopy times were comparable. Thirty day all cause and cardiovascular death were similar between radial and femoral CT groups (respectively 2.4% vs. 7.9%, P = 0.258 and 0% vs. 7.9%, P = 0.063). There were no differences in major vascular complications (4.3% vs. 7.3%, P = 0.553), life threatening or major bleeding events (respectively 9.1% vs. 19.5%, P = 0.168 and 13.6% vs. 22%, P = 0.315). CONCLUSION: In TAVI cases with unfavorable contralateral femoral anatomy, radial CT for vascular access management is a reasonable alternative to the femoral CT.

Transcatheter vs surgical aortic valve replacement in intermediate-surgical-risk patients with aortic stenosis: a propensity score-matched case-control study.

BACKGROUND: Limited real-world data comparing outcomes after transcatheter (TAVR) and surgical aortic valve replacement (SAVR) in intermediate-surgical-risk patients with aortic stenosis are available. METHODS: We identified 182 consecutive patients who underwent TAVR via the transfemoral (TF) route (November 2007-February 2011) and 111 moderate-to-high-risk historical case controls undergoing SAVR (August 2003-July 2008). Using propensity score matching based on clinical characteristics and surgical risk scores, we compared clinical outcomes in 111 matched patients. Valve Academic Research Consortium definitions were applied for end point adjudication. RESULTS: Baseline clinical characteristics, in particular Logistic European System for Cardiac Operative Risk Evaluation (23.2 ± 15.1 vs 24.4 ± 13.4) and Society of Thoracic Surgeons score (4.6 ± 2.3 vs 4.6 ± 2.6), were well matched between groups. Transfemoral TAVR was associated with more vascular complications (33.3% vs 0.9%, P < .001). On the other hand, acute kidney injury was more frequent after SAVR (8.1% vs 26.1%, P < .001). The rates of all-cause mortality in both TF-TAVR and SAVR groups was1.8% at 30 days (P = 1.00) and 6.4% and 8.1%, respectively, at 1 year (P = .80). At 1 year, the rate of cerebrovascular events was similar in the 2 groups (4.6% vs 9.1%, P = .19). CONCLUSIONS: In this real-world cohort of intermediate-surgical-risk patients with aortic stenosis, TF-TAVR and SAVR were associated with similar mortality rates during follow-up but with a different spectrum of periprocedural complications. Furthermore, the survival rate after TF-TAVR in this group of elderly patients with intermediate Society of Thoracic Surgeons score was encouraging.

Complete left atrial ablation with bipolar radiofrequency.

OBJECTIVE: Despite its efficacy and swiftness, bipolar radiofrequency is generally not used on the left isthmus for concern of injuring a coronary branch. Incomplete lesion sets or use of an additional unipolar device are often considered. We report a technique to perform a full left lesion set involving the mitral line using a standard bipolar radiofrequency device. METHODS: An innovative complete left atrial lesion set was performed using only bipolar radiofrequency in 70 consecutive patients (study group). In 67/70 patients (96%) mitral valve disease was the main indication to surgery. Atrial fibrillation was permanent in 42 patients (60%), persistent in 25 (36%) and paroxysmal in three patients (4%). After beating-heart pulmonary vein isolation on-pump, the coronary-free area of the AV groove was marked epicardially by sticking a needle into the left atrial wall, behind the coronary sinus. The projection of the needle marker on the mitral annulus was then identified through the atriotomy and an endo-epicardial ablation was performed with the bipolar device involving the atrial wall, the coronary sinus, up to the annulus. The lesion set was then completed by connecting the encirclings and the left appendage, which was then sutured. Follow-up was 100% complete. Results were compared with those of a control group of 33 patients receiving bipolar radiofrequency left atrial ablations and a mitral connecting line with a second unipolar device. RESULTS: All patients survived. No major complication occurred. Haematoma of the AV groove was observed during retrograde cardioplegia in one case. No myocardial ischaemia or re-exploration for bleeding (median 325 cc, interquartile range 250-442) occurred. Two out of 70 patients required a permanent pacemaker for AV block. Freedom from atrial fibrillation was 84% (95% CI: 75%, 93%) at 6 months and 81% (95% CI: 70%, 93%) at 1 year. One patient had left flutter. Comparison with the control group did not show any difference in clinical outcomes, but revealed bipolar ablation to the mitral annulus to abate the per patient cost of the ablation devices (1245+/-50 euro vs 2403+/-17 euro; p<0.0001). CONCLUSIONS: Performing the mitral line with bipolar radiofrequency is safe and cost-effective. A complete left atrial ablation with a single bipolar radiofrequency device yields excellent clinical mid-term results.

Takotsubo Cardiomyopathy Following Pericardiocentesis After Aortic Valve Repair and Ascending Aorta Replacement.

Takotsubo cardiomyopathy is a reversible cardiomyopathy, which generally developes in menopausal women and is characterized by left ventricle dysfunction with apical ballooning in the absence of coronary artery disease. It is often triggered by a stressful event, and its clinical presentation resembles acute anterior myocardial infarction. This condition is a rare adverse event of cardiac operations, and only a few cases are described in the literature, especially after mitral valve operations. We report the case of a 69-year-old man who underwent aortic valve repair and ascending aorta replacement, followed by pericardial effusion 6 months later, requiring pericardiocentesis resulting in Takotsubo cardiomyopathy.

MitraClip therapy and surgical edge-to-edge repair in patients with severe left ventricular dysfunction and secondary mitral regurgitation: mid-term results of a single-centre experience†.

OBJECTIVES: To compare the surgical and percutaneous edge-to-edge (EE) repair in patients with severe left ventricular (LV) dysfunction and secondary mitral regurgitation (MR). METHODS: We reviewed the prospectively collected data of the first 120 consecutive patients (age: 65 ± 9.8 years, EF: 28 ± 8.2%) treated with surgical (65 patients) or percutaneous (55 patients) EE repair for severe secondary MR in our institution. Age (P = 0.005) and logistic European System for Cardiac Operative Risk Evaluation (P < 0.0001) were significantly higher in the MitraClip group. LVEF (P = 0.37), end-diastolic (P = 0.83) and end-systolic (P = 0.68) volumes and systolic pulmonary artery pressure (SPAP) (P = 0.58) were similar. The follow-up was 100% complete [median: 4 years; interquartile range (IQR): 2.2-7.2]. RESULTS: The length of hospital stay was 10 days (IQR: 8-13) for surgery and 5 days (IQR: 3.9-7.8) for MitraClip (P < 0.0001). Hospital mortality (3 vs 0%, P = 0.49) and freedom from cardiac death at 4 years (80.8 ± 4.9% vs 79.1 ± 5.9%, P = 0.9) were not significantly different in the surgical and MitraClip group, respectively. Residual MR ≥ 2+ at hospital discharge was 7.6% for surgery and 29% for MitraClip (P = 0.002). At 4 years, freedom from MR ≥ 2+ (74.9 ± 5.6% vs 51.4 ± 7.4%, P = 0.01) and freedom from MR ≥ 3+ (92.8 ± 3.4% vs 68.1 ± 7%, P = 0.002) were both significantly higher in the surgical group. Multivariate analysis identified the use of MitraClip as an independent predictor of recurrence of MR ≥ 2+ [Hazard ratio (HR): 2.1, 95% confidence interval (CI): 1.1-3.9, P = 0.02] as well as of MR ≥ 3 (HR: 6.1, 95% CI: 1.5-24.3, P = 0.01). In the surgical group, no predictors of cardiac mortality were identified. In the MitraClip group, left ventricular end-diastolic diameter (HR: 1.1, 95% CI: 1-1.2, P = 0.005) and SPAP (HR: 1, 95% CI: 1-1.1, P = 0.005) were independent predictors of cardiac death at the follow-up. CONCLUSIONS: MitraClip therapy is a safe therapeutic option in selected high-risk patients with secondary MR and relevant comorbidities. The surgical EE provides higher efficacy both postoperatively and at the mid-term follow-up.

Optimal results immediately after MitraClip therapy or surgical edge-to-edge repair for functional mitral regurgitation: are they really stable at 4 years?

OBJECTIVES: Recurrent mitral regurgitation (MR) is common after surgical and percutaneous (MitraClip) treatment of functional MR (FMR). However, the Everest II trial suggested that, in patients with secondary MR and initially successful MitraClip therapy, the results were sustained at 4 years and were comparable with surgery in terms of late efficacy. The aim of this study was to assess whether both those findings were confirmed by our own experience. METHODS: We reviewed 143 patients who had an initial optimal result (residual MR ≤ 1+ at discharge) after MitraClip therapy (85 patients) or surgical edge-to-edge (EE) repair (58 patients) for severe secondary MR (mean ejection fraction 28 ± 8.5%). Patients with MR ≥ 2+ at hospital discharge were excluded. The two groups were comparable. Only age and logistic EuroSCORE were higher in the MitraClip group. RESULTS: Follow-up was 100% complete (median 3.2 years; interquartile range 1.8;6.1). Freedom from cardiac death at 4 years (81 ± 5.2 vs 84 ± 4.6%, P = 0.5) was similar in the surgical and MitraClip group. The initial optimal MitraClip results did not remain stable. At 1 year, 32.5% of the patients had developed MR ≥ 2+ (P = 0.0001 compared with discharge). Afterwards, patients with an echocardiographic follow-up at 2 years (60 patients), 3 years (40 patients) and 4 years (21 patients) showed a significant increase in the severity of MR compared with the corresponding 1 year grade (all P < 0.01). Freedom from MR ≥ 3+ at 4 years was 75 ± 7.6% in the MitraClip group and 94 ± 3.3% in the surgical one (P = 0.04). Freedom from MR ≥ 2+ at 4 years was 37 ± 7.2 vs 82 ± 5.2%, respectively (P = 0.0001). Cox regression analysis identified the use of MitraClip as a predictor of recurrence of MR ≥ 2+ [hazard ratio (HR) 5.2, 95% confidence interval (CI) 2.5-10.8, P = 0.0001] as well as of MR ≥ 3 (HR 3.5, 95% CI 0.9-13.1, P = 0.05). CONCLUSIONS: In patients with FMR and optimal mitral competence after MitraClip implantation, the recurrence of significant MR at 4 years is not uncommon. This study does not confirm previous observations reported in the Everest II randomized controlled trial indicating that, if the MitraClip therapy was initially successful, the results were sustained at 4 years. When compared with the surgical EE combined with annuloplasty, MitraClip therapy provides lower efficacy at 4 years.

Long-Term Outcomes After Transcatheter Aortic Valve Implantation from a Single High-Volume Center (The Milan Experience).

Transcatheter aortic valve implantation (TAVI) is now the treatment of choice for patients with symptomatic aortic stenosis who are inoperable or with high surgical risk. Data with regards to contemporary clinical practice and long-term outcomes are sparse. To evaluate temporal changes in TAVI practice and explore procedural and long-term clinical outcomes of patients in a contemporary "real-world" population, outcomes of 829 patients treated from November 2007 to May 2015, at the San Raffaele Scientific Institute, Milan, Italy, were retrospectively analyzed. Median follow-up was 568 days, with the longest follow-up of 2,677 days. Overall inhospital mortality was 3.5%. During the study period, there was a trend toward treating younger, lower risk patients. Overall mortality rates were 3.5% (30 days), 14% (1 year), 22% (2 years), 29% (3 years), 37% (4 years), 47% (5 years), 53% (6 years), and 72% (7 years). The survival probability at 5 years was significantly higher in patients treated through the transfemoral (TF) route compared to other vascular access sites (log rank p <0.001). Non-TF vascular access and residual paravalvular leak ≥2 (after TAVI) were identified as independent predictors for both all-cause and cardiovascular mortality. No patient required further aortic valve intervention for TAVI prosthesis degeneration. In conclusion, there is a trend toward treating younger, lower-risk patients. Non-TF vascular access approach and ≥2 PVL after TAVI were identified as independent predictors for both overall and cardiovascular mortality with no cases of prosthesis degeneration suggesting acceptable durability.

Predictive ability of the CHADS2 and CHA2DS2-VASc scores for stroke after transcatheter aortic balloon-expandable valve implantation: an Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER) sub-analysis.

OBJECTIVES: Stroke incidence after transcatheter aortic valve implantation (TAVI) still represents a concern. This multicentre study aimed at investigating the hypothesis that CHADS2 and CHA2DS2-VASc scores may be used to predict perioperative stroke after TAVI. METHODS: The Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER) is a multicentre, prospective registry of patients undergoing balloon-expandable TAVI using Edwards Sapien and Sapien XT prosthesis between 2007 and 2012. The primary end-point of this study was the 30-day stroke rate. Secondary safety end-points were all the major adverse events based on Valve Academic Research Consortium (VARC-2) criteria. RESULTS: One thousand nine hundred and four patients were enrolled in the registry. Mean age was 81.6 ± 6.2 years and 1147 (60.2%) patients were female; mean CHADS2 and CHA2DS2-VASc scores were 2.2 ± 0.8 and 4.4 ± 1.1, respectively. Fifty-four (2.8%) patients had a stroke within 30 days. At multivariable logistic regression analysis, CHA2DS2-VASc (OR: 1.35, 95% CI: 1.03-1.78; P = 0.031) and previous cardiac surgery (OR: 1.96, 95% CI: 1.06-3.6; P = 0.033) but not CHADS2 (OR: 1.05, 95% CI: 0.76-1.44; P = 0.77) were found to be independent predictors of in-hospital stroke. A CHA2DS2-VASc score ≥5 was strongly related to the occurrence of in-hospital stroke (OR: 2.51, 95% CI: 1.38-4.57; P= 0.001). However, CHA2DS2-VASc score showed only poor accuracy for in-hospital stroke with a trend for better accuracy when compared with CHADS2 score (area under the curve: 0.61, 95% CI: 0.59-0.63 vs 0.51; 95% CI: 0.49-0.54, respectively, P = 0.092). CONCLUSIONS: In TAVI patients, CHA2DS2-VASc provided a strong correlation for in-hospital stroke but with low accuracy. Dedicated scores to properly tailor procedures and preventive strategies are needed.

Early and mid-term outcomes of 1904 patients undergoing transcatheter balloon-expandable valve implantation in Italy: results from the Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER).

OBJECTIVES: The aim of this multicentre study is to report the clinical experiences of all patients undergoing transcatheter aortic valve implantation (TAVI) with a balloon-expandable device in Italy. METHODS: The Italian Transcatheter balloon-Expandable valve Registry (ITER) is a real-world registry that includes patients who have undergone TAVI with the Sapien (Edwards Lifesciences, Irvine, CA, USA) bioprosthesis in Italy since it became available in clinical practice. From 2007 to 2012, 1904 patients were enrolled to undergo TAVI in 33 Italian centres. Outcomes were classified according to the updated Valve Academic Research Consortium (VARC-2) definitions. A multivariable analysis was performed to identify independent predictors of all-cause mortality. RESULTS: Mean age was 81.7 (SD:6.2) years, and 1147 (60.2%) patients were female. Mean Logistic EuroSCORE was 21.1% (SD:13.7). Transfemoral, transapical, transaortic and transaxillary TAVI was performed in 1252 (65.8%), 630 (33.1%), 18 (0.9%) and 4 (0.2%) patients, respectively. Operative mortality was 7.2% (137 patients). The VARC-2 outcomes were as follows: device success, 88.1%; disabling stroke, 1.0%; life-threatening and major bleeding 9.8 and 10.5%, respectively; major vascular complication, 9.7%; acute kidney injury, 8.2%; acute myocardial infarction ≤72 h, 1.5%. Perioperative pacemaker implantation was necessary in 116 (6.1%) patients. At discharge, the mean transprosthetic gradient was 10.7 (SD:4.5) mmHg. Incidence of postoperative mild, moderate or severe paravalvular leak was, respectively, 32.1, 5.0 and 0.4%. A total of 444/1767 (25.1%) deaths after hospital discharge were reported: of these, 168 (37.8%) were classified as cardiac death. Preoperative independent predictors of all-cause mortality were male gender (HR: 1.395; 95% CI:1.052-1.849); overweight, BMI 25-30 kg/m2 (HR: 0.775; 95% CI: 0.616-0.974); serum creatinine level (every 1 mg/dl increase; HR: 1.314; 95% CI:1.167-1.480); haemoglobin level (every 1 g/dl increase; HR: 0.905; 95% CI:0.833-0.984); critical preoperative state (HR: 2.282; 95% CI: 1.384-3.761); neurological dysfunction (HR: 1.552; 95% CI:1.060-2.272); atrial fibrillation (HR: 1.556; 95% CI:1.213-1.995); pacemaker rhythm (HR: 1.948; 95% CI:1.310-2.896); NYHA Class III or IV (HR: 1.800; 95% CI:1.205-2.689 or HR: 2.331; 95% CI:1.392-3.903, respectively). CONCLUSIONS: TAVI with a balloon-expandable device in the 'real world' shows good mid-term outcomes in terms of survival, technical success, valve-related adverse events and haemodynamic performance.

Preliminary outcomes after transcatheter aortic valve implantation in patients with systemic sclerosis.

AIMS: The aim of this study was to report the feasibility and the preliminary outcomes after transcatheter aortic valve implantation (TAVI) in the frail and unique high-risk population of patients with systemic sclerosis (SSc) and severe aortic stenosis (AS). METHODS AND RESULTS: All patients with SSc and severe AS treated with TAVI between November 2007 and June 2013 in our centre were included in the current study. Outcomes were assessed using the Valve Academic Research Consortium 2 (VARC-2) definitions. Of 526 surgical high-risk patients treated in the study period, only six had SSc (1.1%). All SSc patients underwent transfemoral TAVI under conscious sedation. The procedure was successfully performed in all patients. There was one case of a major vascular complication. During a median follow-up time of 550 days (interquartile range 390-1,009 days), five of the six patients were alive, free from any complications and with an NYHA Class I or II. One patient died at 670 days from a stroke of unknown aetiology. CONCLUSIONS: The present case series suggests that the TAVI procedure is feasible in patients with SSc and severe AS.

Routine Screening of Coronary Artery Disease With Computed Tomographic Coronary Angiography in Place of Invasive Coronary Angiography in Patients Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: Coronary artery disease (CAD) screening is required before transcatheter aortic valve implantation (TAVR). Although invasive coronary angiography (CA) remains the gold standard for CAD assessment, computed tomographic CA (CTCA) could be a safe and effective noninvasive alternative for CAD screening in patients undergoing TAVR. METHODS AND RESULTS: From November 2007 to May 2013, all patients undergoing TAVR at our institution were included in the study cohort. CTCA was used as first-line imaging tool for CAD screening. Invasive CA was performed when any of the following were present: coronary anatomy at CTCA was not evaluable and presence of significant CAD at CTCA. The primary objective was to compare major adverse cardiovascular and cerebrovascular events at 30 days and 1 year between patients who performed CTCA as only screening test and those who performed CTCA and invasive CA. Of 491 patients treated with TAVR, 375 (76.3%) performed only CTCA, whereas 116 (21.7%) underwent also CA. No differences were present in crude major adverse cardiovascular and cerebrovascular event rates at 30 days and 1 year between the 2 groups. After multivariable adjustment, CTCA performed alone was not associated with higher risk of MACE at 1 year of follow-up (hazard ratio, 0.89; 95% confidence interval, 0.49-1.60; P=0.69). CONCLUSIONS: CTCA performed as a routine noninvasive imaging tool in patients undergoing TAVR seems safe and effective allowing, with a single test, acquisition of information on aortic annulus anatomy, peripheral access sites, and evaluation of coronary anatomy.

Clinical outcomes of MitraClip for the treatment of functional mitral regurgitation.

AIMS: The aim of this study was to report medium-term outcomes of MitraClip implantation in inoperable or high-risk surgical candidates with functional mitral regurgitation (FMR) in our single-centre experience. From October 2008, 109 consecutive patients with FMR underwent MitraClip implantation (mean age 69±9 years; 82% NYHA Class III-IV). Logistic EuroSCORE was 22±16%. Comorbidities included: chronic renal failure (47%), diabetes (22%), COPD (28%). Mean EF was 28±11%; LVEDD was 68±8 mm. Procedural success was 99% and 30-day mortality was 1.8%. At discharge, 87% patients had MR ≤2+. At 12 months, EF was 34.7±10.4% (p=0.002 compared to preoperative value). Actuarial survival at three years was 74.5±7%. Actuarial freedom from MR ≥3+ at 2.5 years was 70±6%. At one-year follow-up, 86% of patients were in NYHA Class I-II. Preoperative pro-BNP level ≥1,600 pg/ml was identified as an independent risk factor of mortality at follow-up. MitraClip therapy for FMR is a valuable alternative to surgery in high-risk patients. Higher preoperative pro-BNP level is a risk factor for mortality at follow-up. Although patients treated in current practice are high-risk, the procedure remains safe and effective in selected patients.

Usefulness of baseline activated clotting time-guided heparin administration in reducing bleeding events during transfemoral transcatheter aortic valve implantation.

OBJECTIVES: This study sought to evaluate the impact of baseline activated clotting time (ACT)-guided heparin administration on major bleeding after transfemoral transcatheter aortic valve implantation (TAVI). BACKGROUND: Bleeding after TAVI is frequent and associated with unfavorable prognosis. Proper intraprocedural heparin dose administration may reduce the risk of potential overdosing in this frail study group. METHODS: Of the patients who underwent transfemoral TAVI in our center from November 1, 2007 to June 31, 2012, 362 were retrospectively analyzed. Because abnormally high baseline ACT values were noted, heparin was administered at the operator's discretion, according to baseline ACT (ACT-guided, n = 174) or patient's body weight (non-ACT-guided, n = 188). The primary study objective was 30-day major bleeding as defined by the Valve Academic Research Consortium criteria. Secondary objectives were any life-threatening, and minor bleeding, and other Valve Academic Research Consortium outcomes at 30 days. RESULTS: Bleeding occurred in 167 (46.1%) patients; of these, 76 (21.0%) had major bleeding. The ACT-guided group had a significantly lower occurrence of major (7.5% vs. 33.5%, p < 0.001), life-threatening (12.1% vs. 20.2%, p = 0.04), and any bleeding (25.9% vs. 64.9%, p < 0.001). Conversely, no differences were noted in the other study objectives. After adjustment for potential confounders, the protective odds ratio for ACT-guided therapy on major bleeding was 6.4 (95% confidence interval: 2.3 to 17.9; p < 0.001) at 30 days. CONCLUSIONS: In our experience, heparin administration according to baseline ACT was correlated with a significantly lower occurrence of major bleeding in transfemoral TAVI. This strategy might be a useful tool in reducing bleeding in this high-risk study group.

Computed tomography-based evaluation of aortic annulus, prosthesis size and impact on early residual aortic regurgitation after transcatheter aortic valve implantation.

OBJECTIVES: Computed tomography (CT) is an increasingly utilized method for the evaluation of patient suitability for transcatheter aortic valve implantation (TAVI). The aim of this study was to analyse the role of CT in the choice of prosthesis and the prevention of residual aortic regurgitation (RAR). METHODS: From November 2007 to September 2010, 115 patients (median age 81 years, inter-quantile range (IQR) 76-85; median ejection fraction 55%, IQR 45-60; median logistic EuroSCORE 19.7, IQR 11.0-32.1) undergoing TAVI were evaluated with a pre-procedural CT. An aortic complex was evaluated with multi-planar reconstructions, and we defined significant early RAR as RAR ≥ 2, and prosthesis/annulus mismatch (PAM) as the ratio between prosthesis size and mean annular size. All analyses were conducted for the whole sample and then separately for the two types of prosthesis implanted. RESULTS: An Edwards-SAPIEN(®) prosthesis was implanted in 62 patients (54.7%), and a Medtronic CoreValve(®) in 52 (45.2%). Aortic annulus minimum and maximum diameters were 22.6 ± 2.1 and 26.0 ± 2.3 mm, respectively. The aortic annulus diameter and the length of the free edge of the aortic cusps were linearly related to a 1:1 ratio (P < 0.0001). Significant RAR (34 patients, 30%) appeared directly related to the annulus diameters (particularly maximum and medium diameters, P = 0.0003 and P = 0.0010, respectively) and cusp length (P = 0.0007) but inversely correlated with PAM (P = 0.0006). Prosthesis/annulus oversizing was associated with a reduction in RAR, with a cut-off of 7% as the limit below which RAR increases; moreover, we observed different cut-off values for the Edwards and CoreValve prostheses, although statistical significance was not reached for the CoreValve (respectively, 2% with P < 0.0001, 11% with P = 0.16). No association was found between PAM and possible PAM-related complications. CONCLUSIONS: CT evaluation prior to TAVI showed that RAR was directly correlated with aortic root dimensions (particularly maximum and medium annulus diameters and cusp lengths) and inversely correlated with PAM. Oversizing the prosthesis by at least 7% reduces the risk of RAR. CT is an essential and invaluable tool in the assessment of patients undergoing TAVI.

The impact of transcatheter aortic valve implantation on patients' profiles and outcomes of aortic valve surgery programmes: a multi-institutional appraisal.

OBJECTIVES: The aim of this retrospective multicenter study was to assess how the development of transcatheter aortic valve implantation (TAVI) influenced the characteristics and outcomes of patients undergoing aortic valve procedures. METHODS: We reviewed 1395 patients who underwent isolated surgical aortic valve replacement (SAVR) or TAVI in three centres with a high-volume TAVI programme. Patients were divided into two groups: 'Pre-TAVI' (395 patients, 28.3%) and 'Post-TAVI' (1000 patients, 71.7%) operated on before and after the introduction of TAVI into clinical practice. We evaluated age, logistic EuroSCORE I (LES) and hospital mortality according to time periods and the procedure performed, whether SAVR or TAVI. RESULTS: 'Post-TAVI' patients were older (78.2 ± 7.8 vs 76.8 ± 6.7 years; P = 0.002) and with a significantly higher LES (17.8 ± 14.7 vs 9.1 ± 9.2%; P < 0.001) than 'Pre-TAVI' patients. Hospital mortality was not significantly different between groups ('Pre-TAVI' vs 'Post-TAVI': 2 vs 3.4%; P = 0.17). Of the 1000 'Post-TAVI' patients, 605 (60.5%) underwent TAVI and 395 (39.5%), SAVR. Patients undergoing TAVI were older (79.9 ± 7.1 vs 75.5 ± 9.2 years; P < 0.001) and with a higher LES (22.9 ± 15.3 vs 9.7 ± 9.3%; P < 0.001) than 'Post-TAVI' SAVR patients, but their hospital mortality was similar (3.9 vs 2.5%; P = 0.22). LES was similar between 'Pre-TAVI' and 'Post-TAVI' SAVR patients (9.1 ± 9.2 vs 9.7 ± 9.3%; P = 0.26). Furthermore, we did not find significant differences in the overall hospital mortality between SAVR and TAVI patients: 2.3 vs 3.9%, P = 0.08. CONCLUSIONS: This analysis shows that the development of TAVI has caused an increase in the preoperative risk profile of patients scheduled for aortic valve procedures (SAVR or TAVI) without increasing hospital mortality.

Managing patients with an indication for anticoagulant therapy after transcatheter aortic valve implantation.

Patients who undergo transcatheter aortic valve implantation are generally discharged on dual-antiplatelet therapy. However, many of these patients also have indications for anticoagulant therapy, and it is unclear what the best antithrombotic strategy is in these cases. Data from 360 patients who underwent transcatheter aortic valve implantation were retrospectively analyzed, of whom 60 (16.7%) had indications for anticoagulant treatment, mainly because of atrial fibrillation. The antithrombotic regimen was decided according to clinical evaluation of thrombotic and hemorrhagic risk; most of these patients (n = 43) were discharged with warfarin plus a single antiplatelet drug. Their outcomes were compared to those in a group with no indications for anticoagulation (n = 300) treated with dual-antiplatelet therapy. During the follow-up period (median 11 months), 53 patients (15%) died; mortality was not associated with antithrombotic regimen. The incidence of cerebral events or intracranial hemorrhage (4.6% and 1.1%, respectively) was low in the study population, and no significant differences were detected between groups; the bleeding rate was also unaffected by antithrombotic therapy. In conclusion, when anticoagulation is indicated after transcatheter aortic valve implantation, many variables must be taken into account. The most frequent scenario in this study was patients in atrial fibrillation, most of whom were discharged with warfarin plus a single antiplatelet medication. When bleeding was a concern, especially in the absence of coronary disease, warfarin alone was prescribed. These results suggest that this approach is safe, but data from larger, randomized studies are needed.

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.

Comparison of incidence and predictors of left bundle branch block after transcatheter aortic valve implantation using the CoreValve versus the Edwards valve.

Conduction disorders and permanent pacemaker implantation are common complications in patients who undergo transcatheter aortic valve implantation (TAVI). The aim of this study was to assess the incidence and clinical significance of new bundle branch block in patients who underwent TAVI with the Medtronic CoreValve Revalving System (MCRS) or the Edwards SAPIEN valve (ESV). Data from 238 patients with no previous pacemaker implantation, left bundle branch block (LBBB) or right bundle branch block at baseline electrocardiography who underwent TAVI with either MCRS (n = 87) or ESV (n = 151) bioprostheses from 2007 to 2011 were analyzed. New-onset LBBB occurred in 26.5% patients (n = 63): 13.5% with the ESV (n = 20) and 50.0% with the MCRS (n = 43) (p = 0.001). Permanent pacemaker implantation was required in 12.7% of patients (n = 8) because of complete atrioventricular block (ESV n = 2, MCRS n = 4), LBBB and first degree atrioventricular block (MCRS n = 1) and new-onset LBBB associated with sinus bradycardia (MCRS n = 1). At discharge, LBBB persisted in 8.6% of ESV patients (n = 13) and 32.2% of MCRS patients (n = 28) (p = 0.001). On multivariate analysis, the only predictor of LBBB was MCRS use (odds ratio 7.2, 95% confidence interval 2.9 to 17.4, p <0.001). Persistent new-onset LBBB at discharge was not associated with overall (log-rank p = 0.42) or cardiovascular (log-rank p = 0.46) mortality. New-onset right bundle branch block was documented in 4.6% of patients (n = 11), with no statistically significant differences between the ESV and MCRS. In conclusion, new-onset LBBB is a frequent intraventricular conduction disturbance after TAVI with a higher incidence with the MCRS compared with the ESV. LBBB persists in most patients, but in this cohort, it was not a predictor of overall or cardiovascular mortality or permanent pacemaker implantation.

Clinical outcome and quality of life in octogenarians following transcatheter aortic valve implantation (TAVI) for symptomatic aortic stenosis.

OBJECTIVE: TAVI is the alternative option in pts with AS deemed ineligible for surgery. Although mortality and morbidity are measures to assess the effectiveness of treatments, quality of life (QOL) should be an additional target. We assessed clinical outcome and QOL in octogenarians following TAVI. DESIGN: All octogenarians with a risk profile considered by the Heart Team to be unacceptable for surgery entered in this registry. QOL was assessed by questionnaires concerning physical and psychic performance. PATIENTS: A hundred forty-five octogenarians (age: 84.7 ± 3.4 years; male: 48.3%) underwent TAVI for AS (97.2%) or isolated AR (2.8%). NYHA class: 2.8 ± 0.6; Logistic EuroScore: 26.1 ± 16.7; STS score: 9.2 ± 7.7.Echocardiographic assessments included AVA (0.77 ± 0.21 cm2), mean/peak gradients (54.5 ± 12.2/88 ± 19.5 mm Hg), LVEF (21%=EF ≤ 40%), sPAP (43.1 ± 11.6 mmHg). INTERVENTIONS: All pts underwent successful TAVI using Edward-SAPIEN valve (71.2%) or Medtronic CoreValve (28.8%). MAIN OUTCOME MEASURES: Rates of mortality at 30 days, 6 months and 1 year were 2.8%, 11.2% and 17.5%. RESULTS: At 16-month follow up, 85.5% survived showing improved NYHA class (2.8 ± 0.6 vs 1.5 ± 0.7; p<0.001), decreased sPAP (43.1 ± 11.6 mm Hg vs 37.1 ± 7.7 mm Hg; p<0.001) and increased LVEF in those with EF ≤ 40% (34.9 ± 6% vs 43.5 ± 14.4%; p=0.006). Concerning QOL, 49% walked unassisted, 79% (39.5% among pts ≥ 85 years) reported self-awareness improvement; QOL was reported as "good" in 58% (31.4% among pts ≥ 85 years), "acceptable according to age" in 34% (16% among pts ≥ 85 years) and "bad" in 8%. CONCLUSION: TAVI procedures improve clinical outcome and subjective health-related QOL in very elderly patients with symptomatic AS.

Quality of life improvement is maintained up to two years after transcatheter aortic valve implantation in high-risk surgical candidates.

AIMS: The aim of the study was to investigate the changes in quality of life (QoL) following transcatheter aortic valve implantation (TAVI) up to two years' follow-up. METHODS AND RESULTS: One hundred consecutive patients (46 females, mean age 79.7 ± 6.1 years) with at least two years' follow-up who underwent TAVI in our institution, between November 2007 and September 2009, were enrolled in this study. Peak and mean aortic gradients were 87.8 ± 25.8 mmHg and 53.3 ± 15.4 mmHg, respectively. Mean log EuroSCORE was 27.9 ± 15.9. Patients had multiple comorbidities. All patients underwent a standardised prospective screening pathway, including QoL evaluation with the 36-item short-form health survey (SF-36v2(®)) and the Minnesota Living with Heart Failure Questionnaires (MLHFQ). The scores obtained preoperatively were compared with those obtained at two years' follow-up. An Edwards SAPIEN valve (Edwards Lifesciences, Irvine, CA, USA) was implanted in 67 patients (55 transfemoral and 12 transapical) and a CoreValve (Medtronic, Inc., Minneapolis, MN, USA) was implanted in 33 patients (26 transfemoral and seven transaxillary). Thirty-day mortality was 4%. Actuarial survival was 80.6 ± 4.1%, 72.6 ± 4.7% and 63.2 ± 6.3% at one, two and three years, respectively. Mean SF36-physical improved from 31.9 ± 8.8 to 51.5 ± 9.5 (p<0.0001) and SF36-mental improved from 44.7 ± 11.6 to 49.5 ± 8.6 (p=0.0002). Mean MLHFQ decreased from 41.5 ± 14.5 to 15.9 ± 13.7 (p<0.0001). QoL score changes were not influenced by age or comorbidities. CONCLUSIONS: TAVI in high-risk surgical candidates is associated with favourable short and long-term survival and with improvement of QoL up to two years after the procedure.