Augusto D'Onofrio

Safety and effectiveness of a selective strategy for coronary artery revascularization before transcatheter aortic valve implantation

We assessed the safety and effectiveness of a selective percutaneous revascularization strategy before TAVI in a single‐center prospective registry.

Unravelling the (arte)fact of increased pacemaker rate with the Edwards SAPIEN 3 valve.

AIMS Early data on the Edwards SAPIEN 3 valve (S3-THV) have shown low rates of paravalvular leaks and vascular complications but relatively high 30-day permanent pacemaker implantation (PPMI) rates. No direct comparisons on clinical outcomes including PPMI rates are available for the S3-THV and the Edwards SAPIEN XT (XT-THV). We aimed to compare the 30-day PPMI rates in patients treated with the two prostheses and to assess the interplay among valve type, depth of implantation and PPMI rate. METHODS AND RESULTS Two hundred and nine patients treated by TAVI were considered. The S3-THV was associated with higher PPMI rates compared to the XT-THV, both overall and in subgroups matched for several predictors of PPMI. However, in the S3-THV group, 30-day PPMI was strictly associated with deep valve implantation, and PPMI risk of high-implanted S3-THVs was similar to that of the overall XT-THV matched group. No cases of significant paravalvular leak were observed in the S3-THV group. CONCLUSIONS The S3-THV was associated with a higher incidence of PPMI compared to the XT-THV. In the S3-THV group, pacemaker implantation was strictly associated with deep valve implantation. An implantation technique involving higher initial placement of the central marker (from 0 to 3 mm above the base of the aortic cusps) and, as a consequence, higher final valve depth might help in preventing post-TAVI PPMI with the S3-THV, without affecting the risk of paravalvular leak.

Impact of preoperative mitral valve regurgitation on outcomes after transcatheter aortic valve implantation

OBJECTIVES The aim of this single-centre prospective study was to assess the impact of preoperative mitral valve regurgitation (MR) on outcomes of patients undergoing transcatheter aortic valve implantation (TAVI). METHODS From June 2007 to January 2011, 176 consecutive patients underwent TAVI at our institution. Patients were divided into two groups according to the degree of MR: <2+, the NoMR group (133 patients); ≥2+, the MR group (43 patients). Clinical and echocardiographic examination were performed before the procedure, at discharge, 1, 3, 6, 12 months after TAVI and yearly thereafter. The mean follow-up was 10.4 ± 7.7 months (range 1-36). RESULTS MR patients had higher EuroSCORE (27 ± 16 vs. 20 ± 11%, P < 0.001), lower ejection fraction (49 ± 13 vs. 57 ± 12%, P = 0.001), higher systolic pulmonary pressure (50 ± 17 vs. 39 ± 10 mmHg, P < 0.001) and larger left ventricular volumes (end-diastolic volume index: 78 ± 29 vs. 66 ± 20 ml/m(2), P = 0.002) than NoMR. Hospital mortality was 9.3% (four patients) and 3% (four patients) in MR and NoMR groups, respectively (P = 0.10). The Kaplan-Meier survival at 20 months was 78 ± 8 and 75 ± 6% in MR and NoMR groups, respectively (P: n.s.). At follow-up, the degree of MR in the MR group decreased to trivial-mild in 28% of patients. Patients of both groups experienced a significant reduction in the New York Hear Association class, being in class I-II in 91% of cases. CONCLUSIONS Patients undergoing TAVI with preoperative MR ≥ 2+ have a higher surgical risk profile and a trend towards higher hospital mortality. MR was not identified as a risk factor for mortality. At follow-up, a reduction in MR and an improvement of echocardiographic parameters were observed in the MR group.

Mid-term results after extensive vein patch reconstruction and internal mammary grafting of the diffusely diseased left anterior descending coronary artery

OBJECTIVE To analyze the results of extensive reconstruction of the left anterior descending coronary artery (LAD) by an autologous vein patch, with or without endarterectomy (EA), associated with left internal mammary artery grafting onto the patch. METHODS Between January 1994 and April 2001, among 5871 myocardial revascularizations, 83 patients (1.4%), 77 male (93%), with a mean age+/-SD of 64+/-8 years (range 44-84) underwent the above mentioned procedure. Seventy-three of them (88%) were in Canadian Cardiovascular Society (CCS) Class III or IV, and 78 (94%) had a three-vessel disease. Mean preoperative ejection fraction was 58+/-12%. Risk factors included hypertension (63%), family history (51%), hyperlipidemia (41%), smoking (38%), diabetes (19%). Mean number of anastomoses/patient was 3+/-0.6. Mean length of vein patch was 2.8+/-0.9 cm (range 2-6 cm). A total of 16% of the patients underwent associated LAD-EA (mean cardiopulmonary bypass time: 132+/-21 min; mean aortic crossclamp time: 81+/-15 min). RESULTS There was one hospital death (recurrent MI, 1.2%). Seven patients (8%) had a perioperative myocardial infarction, in three cases in the region supplied by the LAD (none after associated LAD-EA). Mean follow-up period was 47+/-20 months (range 5-90) and is 99% complete. There were five late cardiac deaths (6%). A total of 74% survivors have no symptoms, 12% are in CCS Class I-II, and 14% in III-IV. Actuarial freedom from recurrent angina at 3 and 5 years is 77 and 69%, respectively. Follow-up angiograms (49 patients, 60%) revealed a full patent LAD graft in 82% of the cases (GI), versus poor run-off/occluded graft in the remaining 18% (GII). Anginal status was significantly worse in GII patients (P<0.05). CONCLUSIONS Extended reconstruction of the LAD coronary artery increases surgical risk. The procedure however enhances the probability for a complete revascularization in patients with an unfavourable anatomical substrate, with acceptable mid-term 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.

Clinical impact and evolution of mitral regurgitation following transcatheter aortic valve replacement: a meta-analysis

Objectives Mitral regurgitation (MR) is a common entity in patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), but its influence on outcomes remains controversial. The purpose of this meta-analysis was to assess the clinical impact of and changes in significant (moderate–severe) MR in patients undergoing TAVR, overall and according to valve design (self-expandable (SEV) vs balloon-expandable (BEV)). Methods All national registries and randomised trials were pooled using meta-analytical guidelines to establish the impact of moderate–severe MR on mortality after TAVR. Studies reporting changes in MR after TAVR on an individual level were electronically searched and used for the analysis. Results Eight studies including 8015 patients (SEV: 3474 patients; BEV: 4492 patients) were included in the analysis. The overall 30-day and 1-year mortality was increased in patients with significant MR (OR 1.49, 95% CI 1.16 to 1.92; HR 1.32, 95% CI 1.12 to 1.55, respectively), but a significant heterogeneity across studies was observed (p<0.05). The impact of MR on mortality was not different between SEV and BEV in meta-regression analysis for 30-day (p=0.360) and 1-year (p=0.388) mortality. Changes in MR over time were evaluated in nine studies including 1278 patients. Moderate–severe MR (SEV: 326 patients; BEV: 192 patients) improved in 50.5% of the patients at a median follow-up of 180 (30–360) days after TAVR, and the degree of improvement was greater in patients who had received a BEV (66.7% vs 40.8% in the SEV group, p=0.001). Conclusions Concomitant moderate–severe MR was associated with increased early and late mortality following TAVR. A significant improvement in MR severity was detected in half of the patients following TAVR, and the degree of improvement was greater in those patients who had received a BEV.

Cardiac rehabilitation after transcatheter versus surgical prosthetic valve implantation for aortic stenosis in the elderly.

Background Transcatheter aortic valve implantation plays a leading role in the management of aortic stenosis in patients with comorbidities but no data are available about cardiac rehabilitation in these subjects. This study aimed to compare safety and efficacy of an early, exercise-based, cardiac rehabilitation programme in octogenarians after a traditional surgical aortic valve replacement versus transcatheter aortic valve implantation. Methods Seventy-eight consecutive transcatheter aortic valve implantation patients were studied in order to evaluate the effect of an exercise-based cardiac rehabilitation programme in comparison to 80 of a similar age having surgical aortic valve replacement. Functional capacity was assessed by a 6 min walking test on admission and at the end of the programme. When possible, a cardiopulmonary exercise test was also performed before discharge. Results The two groups were similar in terms of gender and length of stay in cardiac rehabilitation; as expected, the transcatheter aortic valve implantation group had more comorbidities but no major complications occurred in either group during rehabilitation. All patients enhanced autonomy and mobility and were able to walk at least with the assistance of a stick. In those patients who were able to perform the 6 min walking test, the distance walked at discharge did not significantly differ between the groups (272.7 ± 108 vs. 294.2 ± 101 m, p = 0.42), neither did the exercise capacity assessed by cardiopulmonary exercise test (peak-VO2 12.5 ± 3.6 vs. 13.9 ± 2.7 ml/kg/min, p = 0.16). Conclusions Cardiac rehabilitation is feasible, safe and effective in octogenarian patients after transcatheter aortic valve implantation as well as after traditional surgery. An early cardiac rehabilitation programme enhances independence, mobility and functional capacity and should be highly encouraged.

Impact of previous cardiac operations on patients undergoing transapical aortic valve implantation: results from the Italian Registry of Transapical Aortic Valve Implantation.

OBJECTIVES Redo cardiac surgery has an increased risk of morbidity and mortality when compared with the initial operation. The aim of this study was to assess the impact of previous cardiac operations on patients undergoing transapical aortic valve implantation (TA-TAVI). METHODS We analysed data from 566 patients included in the Italian Registry of Transapical Aortic Valve Implantation who underwent TA-TAVI implantation with the Sapien valve (Edwards Lifesciences, Irvine, CA, USA) from April 2008 through May 2011. Of these, 110 patients (19.4%) had already undergone at least one previous cardiac operation with opening of the pericardium (group R) while for 456 patients (80.6%) TA-TAVI was the first cardiac procedure (group F). Data were prospectively collected at each of the 20 participating centres and then sent to a central database for storage and analysis. RESULTS Preoperative logistic EuroSCORE was higher in group R (35 ± 18.6 vs. 23.5 ± 11.9%; P < 0.001). Hospital mortality occurred in eight (7.2%) and 36 (7.9%) patients in groups R and F, respectively (P = 0.8). Mean follow-up was 10.4 ± 7.9 months (range: 1-34). Overall 2-year Kaplan-Meier survival was 64.2 ± 9.8 and 75.4 ± 3.5% in groups R and F, respectively (P = 0.69). Incidence of operative complications, postoperative bleeding, pacemaker implantation, myocardial infarction and stroke did not show statistically significant differences between groups. The univariate analysis showed that arterial hypertension, logistic EuroSCORE, porcelain aorta, left ventricular ejection fraction and previous percutaneous coronary interventions were significantly associated with 30-day mortality in group R. CONCLUSIONS According to our data, patients undergoing TAVI with previous cardiac operations have a higher preoperative risk profile but have similar outcomes when compared with patients undergoing a first operation. In these subset of patients, TAVI is a promising therapeutic option.

Transapical aortic valve implantation in high-risk patients with severe aortic valve stenosis.

BACKGROUND Transapical aortic valve implantation (TA-TAVI) represents an alternative in patients with symptomatic severe aortic valve stenosis (SSAVS) who cannot be operated on or have a high surgical risk. The aim of this prospective multicenter observational study was to assess early and 2-year clinical and hemodynamic outcomes after TA-TAVI. METHODS From May 2008 to September 2010, 179 patients with inoperable conditions or high-risk patients underwent TA-TAVI at 4 institutions. Indications for TA-TAVI were SSAVS and logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) greater than 20% or porcelain aorta in patients with severe aortoiliac disease. Patients underwent clinical and echocardiographic follow-up visits at hospital discharge, 3 and 6 months after TA-TAVI, and every 6 months thereafter. The impact of the learning curve for the centers and of intraoperative complications on patient outcomes was also evaluated. RESULTS Mean age was 81 ± 6 years. Mean logistic EuroSCORE was 22% ± 12%. Transapical delivery was successful in all patients. Seventeen severe intraoperative complications occurred in 13 (7.3%) patients. Thirty-day mortality was 3.9% (7 patients). Mean follow-up was 9.2 ± 6.5 months. Late mortality occurred in 9 patients. Two-year survival was 88% ± 3%. An intraoperative severe complication was identified as the only significant independent predictor of 1-year mortality. A significant benefit was found when comparing 2-year survival of the second versus the first 50% patients at each center (93% ± 2% versus 84% ± 3 %; p = 0.046). A significant reduction of both mean and peak gradients from the preoperative to the postoperative period, which remained stable during follow-up, was found. CONCLUSIONS TA-TAVI provides excellent early and 2-year results in terms of survival, valve-related adverse events, and hemodynamic performance. Survival after TA-TAVI is affected by the center learning curve and by the occurrence of an intraoperative complication.

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.