Abstract Advanced chronic kidney disease (CKD) is associated with poor outcomes in patients undergoing surgical aortic valve replacement while its prognostic role in transcatheter aortic valve ...implantation (TAVI) remains unclear. This study aimed to investigate outcomes in patients with advanced CKD undergoing TAVI. 1904 consecutive patients undergoing balloon-expandable TAVI in 33 centers between 2007-2012 were enrolled in the I talian T ranscatheter Balloon- E xpandable Valve Implantation R egistry (ITER). Advanced CKD was defined according to estimated glomerular filtration rate (eGFR): 15-29 mL/min/1.73m2 stage 4 (S4), <15 mL/min/1.73m2 stage 5 (S5). Edwards Sapien or Sapien-XT prosthesis were used. Primary end-point was all-cause mortality during follow-up. Secondary end-points were 30-days and FU major-adverse-cardiac-events (MACE), defined with VARC-2 criteria. 421 patients were staged S5 (n=74) or S4 (n=347). S5 patients were younger, had more frequently porcelain aorta and lower incidence of previous stroke. Peri-procedural and 30-days outcomes were similar in S5 and S4 patients. During a 670 (±466) days of FU, S5 patients suffered higher mortality rates (69% vs. 39%, p<0.01) and cardiac death (19% vs. 9%, p=0.02) compared to S4. Male sex (HR 1.6, 95%CI 1.2-2.2), LVEF<30% (HR 2.3, 95% CI: 1.3-4), atrial fibrillation (HR 1.4, 95%CI:1.0-1.9) and S5 CKD (HR 1.5, 95%CI: 1.0-2.1) were independent predictors of death. In conclusion, TAVI in pre-dialytic or dialytic patients (i.e. S5) is independently associated with poor outcomes with more than double risk of death compared to patients with stage 4 renal function. Conversely, in severe CKD (i.e. S4) a rigorous risk stratification is required to avoid the risk of futility risk.
Abstract Objective Transcatheter aortic valve implantation (TAVI) and sutureless aortic valve replacement (SU-AVR) are suitable alternatives to conventional surgery. The aim of this study is to ...compare early outcomes of patients undergoing TAVI and SU-AVR. Methods Data were analyzed on patients who underwent TAVI and patients who underwent SU-AVR. Two matched cohorts (TAVI vs SU-AVR) were created using propensity scores; all analyses were repeated for transapical TAVI and transfemoral TAVI, separately. Outcomes were defined according to Valve Academic Research Consortium–2 criteria. Results A total of 2177 patients were included in the analysis: 1885 (86.6%) treated with TAVI; 292 (13.4%) treated with SU-AVR. Mortality in unmatched TAVI and SU-AVR patients was 7.1% and 2.1%, respectively, at 30 days, and 12.9% and 4.6%, respectively, at 1 year. No differences were found in 30-day mortality in the 214 matched patient pairs (3.7% vs 2.3%; P = .4), but patients treated with TAVI showed a lower incidence of device success (85.9% vs 98.6%; P < .001) and pacemaker implantation (2.8% vs 9.4%; P = .005), and a higher incidence of any paravalvular leakage (PVL). Conclusions SU-AVR is associated with better device success and a lower incidence of PVL, compared with TAVI. Nevertheless, patients treated with SU-AVR were more likely to receive a permanent pacemaker. SU-AVR and TAVI provide good results in patients who have severe symptomatic aortic valve stenosis. Given the multiple therapeutic options available, patients may receive the treatment that is most appropriate for their clinical and anatomical characteristics.
Background Acute fulminant myocarditis (AFM) may represent a life-threatening event, characterized by rapidly progressive cardiac compromise that ultimately leads to refractory cardiogenic shock or ...cardiac arrest. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) provides effective cardiocirculatory support in this circumstance, but few clinical series are available about early and long-term results. Data from a multicenter study group are reported which analyzed subjects affected by AFM and treated with VA-ECMO during a 5-year period. Method From hospital databases, 57 patients with diagnoses of AFM treated with VA-ECMO in the past 5 years were found and analyzed. Mean age was 37.6 ± 11.8 years; 37 patients were women. At VA-ECMO implantation, cardiogenic shock was present in 38 patients, cardiac arrest in 12, and severe hemodynamic instability in 7. A peripheral approach was used with 47 patients, whereas 10 patients had a central implantation or other access. Results Mean VA-ECMO support was 9.9 ± 19 days (range, 2 to 24 days). Cardiac recovery with ECMO weaning was achieved in 43 patients (75.5%), major complications were observed in 40 patients (70.1%), and survival to hospital discharge occurred in 41 patients (71.9%). After hospital discharge (median follow-up, 15 months) there were 2 late deaths. The 5-year actual survival was 65.2% ± 7.9%, with recurrent self-recovering myocarditis observed in 2 patients (at 6 and 12 months from the first AFM event), and 1 heart transplantation. Conclusions Cardiopulmonary support with VA-ECMO provides an invaluable tool in the treatment of AFM, although major complications may characterize the hospital course. Long-term outcome appears favorable with rare episodes of recurrent myocarditis or cardiac-related events.
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.
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 cm2 . 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.
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.
Objectives The goal of this study was to evaluate the safety and performance of the NeoChord DS1000 system (NeoChord, Inc., Minneapolis, Minnesota). Background There is an increasing interest in ...transcatheter mitral valve (MV) treatment. The NeoChord DS 1000 system enables off-pump beating heart transapical MV repair with implantation of artificial neo-chordae. Methods Patients with severe mitral regurgitation (MR) due to isolated posterior prolapse were included in this TACT (Transapical Artificial Chordae Tendinae) trial. All patients were scheduled for off-pump transapical implantation of neo-chordae. Results Thirty patients at 7 centers were enrolled. Major adverse events included 1 death due to post-cardiotomy syndrome and concomitant sepsis and 1 minor stroke with the patient fully recovered at the 30-day follow-up visit. Additional patients experienced procedural major adverse events related to a reoperation or conversion to standard of care. Acute procedural success (placement of at least 1 neo-chord and reduction of MR from 3+ or 4+ to ≤2+) was achieved in 26 patients (86.7%). In 4 patients neo-chordae were not placed for technical and/or patient-specific reasons. These patients underwent intraoperative (3 patients) or post-operative (1 patient) standard MV repair. At 30 days, 17 patients maintained an MR grade ≤2+. Four patients who developed recurrent MR were successfully treated with open MV repair during 30-day follow-up. Results improved with experience: durable reduction in MR to ≤2+ at 30 days was achieved in 5 (33.3%) of the first 15 patients and 12 (85.7%) of the last 14 patients. Conclusions Off-pump transapical implantation of artificial chordae to correct MR is technically safe and feasible; however, it yields further potential for improvement of efficacy and durability. (Safety and Performance Study of the NeoChord Device TACT; NCT01777815 )
Objective The aim of this propensity-matched, multicenter study was to compare early clinical and echocardiographic outcomes of patients undergoing transapical aortic valve implantation (TA-TAVI) ...versus patients undergoing sutureless aortic valve replacement (SU-AVR) for severe symptomatic aortic valve stenosis. Methods We reviewed 468 TA-TAVIs performed in 20 centers from April 2008 to May 2011, and 51 SU-AVRs performed in 3 centers from March to September 2011. Based on a propensity score analysis, 2 groups with 38 matched pairs were created. Variables used in the propensity analysis were age, sex, body surface area, New York Heart Association class, logistic EuroSCORE, peripheral vascular disease, chronic obstructive pulmonary disease, aortic valve area, mitral regurgitation, and left ventricular ejection fraction. Results Preoperative characteristics of the 2 groups were comparable. Hospital mortality was 5.3% and 0% in the TA-TAVI and SU-AVR groups, respectively ( P = .49). We did not observe stroke or acute myocardial infarction in the 2 groups. Permanent pacemaker implantation was needed in 2 patients of each group (5.3%, P = 1.0). Dialysis was required in 2 patients (5.3%) in the SU-AVR group and in 1 patient (2.7%) in the TA-TAVI group ( P = 1.0). Predischarge echocardiographic data showed that the incidence of paravalvular leak (at least mild) was greater in the TA-TAVI group (44.7% vs 15.8%, P = .001), but there were no differences in terms of mean transprosthetic gradient (10.3 ± 5 mm Hg vs 11 ± 3.7 mm Hg, P = .59). Conclusions This preliminary experience showed that, in patients at high risk for conventional surgery, SU-AVR is as safe and effective as TA-TAVI and that it is associated with a lower rate of postprocedural paravalvular leak.
Midterm outcomes for patients presenting with heart failure and functional mitral regurgitation (MR) treated with Mitraclip remain unclear. Pubmed, Medline, and Google Scholar were systematically ...searched for studies enrolling patients with severe-moderate MR who underwent Mitraclip implantation. All events after at least 6 months were the primary safety end point (including death, rehospitalization for heart failure, and reinterventions), whereas change in the ejection fraction, left ventricular volumes, arterial pulmonary pressure, and left atrial diameters were considered as secondary end points. Meta-regression analysis was performed to evaluate the effect of baseline clinical and echocardiographic parameters on efficacy outcomes: 875 patients were included in 9 studies; 1.48 clips (1.3 to 1.7) for patients were implanted, and after a median follow-up of 9 months (6 to 12), 409 patients (78% 75% to 83%) were in class New York Heart Association I/II and 57 (11% 8% to 14%) still had moderate-to-severe MR. Overall adverse events occurred in 137 (26% 20% to 31%) of the patients and 78 (15% 1% to 17%) of them died; 6-minute walk test improved by 100 m (83 to 111), whereas a significant reduction in left ventricular volumes and systolic pulmonary pressure was reported. At meta-regression analysis, an increase in left ventricle systolic volumes positively affected reduction of volumes after Mitraclip, whereas atrial fibrillation reduced the positive effect of the valve implantation on ejection fraction on end-diastolic and -systolic volumes. In conclusion, Mitraclip represents an efficacious strategy for patients with heart failure and severe MR. It offers a significant improvement in functional class and in cardiac remodeling, in patients with severely dilated hearts as well, although its efficacy remains limited in the presence of atrial fibrillation.
Background Interest in right minithoracotomy mitral valve surgery (MVS) is rapidly growing and, to date, different perfusion strategies and aortic clamping techniques are available. However each ...approach carries specific advantages and drawbacks. This retrospective study analyses our experience in right minithoracotomy MVS with different arterial perfusion and aortic clamping strategies, highlighting the results of a patient tailored approach. Methods Between March 2009 and March 2014, 460 patients with a full preoperative work-up that included also aortoiliac-femoral axis’ screening underwent right minithoracotomy MVS. One hundred and eight were redo cases (23.5%), 63 had aortoiliac atheromatous disease or significant tortuosity (13.7%), and 38 had chronic obstructive pulmonary disease (8.3%). Based on anatomy and comorbidities, each patient was allocated to the most appropriate of 3 approaches: femoral arterial cannulation with endoaortic balloon (P+EB) (247, 53.7%) or with transthoracic clamp (P+XC) (150, 32.6%), and direct aortic cannulation with endoaortic balloon occlusion (C+EB) (63, 13.7%). Results No cases of aortic dissection were reported. Early outcome were similar between the 3 groups; no differences were reported in terms of stroke rate (1.7% in the P+EB, 2% in the P+XC, and no cases in the C+EB group; p = NS) and 30-day mortality (2.1% in the P+EB, 2.7% in the P+XC, and 1.6% in the C+EB group; p = NS). Logistic regression showed no influences of arterial perfusion and aortic clamping techniques on 30-day mortality and stroke. Conclusions Right minithoracotomy MVS can routinely be performed with favorable outcomes in all comers when perfusion strategies and clamping techniques are carefully selected after proper evaluation of the patient’s preoperative characteristics.
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