IMPORTANCE: Stroke remains a major predictor of mortality after transcatheter aortic valve implantation (TAVI). Cerebral protection devices might reduce brain injury as determined by ...diffusion-weighted magnetic resonance imaging (DWMRI). OBJECTIVE: To determine the effect of a cerebral protection device on the number and volume of cerebral lesions in patients undergoing TAVI. DESIGN, SETTING, AND PARTICIPANTS: Investigator-initiated, single center, blinded, randomized clinical trial in higher-risk patients with severe aortic stenosis undergoing TAVI at the University of Leipzig Heart Center. Brain MRI was performed at baseline, 2 days, and 7 days after TAVI. Between April 2013 and June 2014, patients were randomly assigned to undergo TAVI with a cerebral protection device (filter group) or without a cerebral protection device (control group). The last 1-month follow-up occurred in July 2014. INTERVENTIONS: TAVI with or without a cerebral protection device (filter system). MAIN OUTCOMES AND MEASURES: The primary end point was the numerical difference in new positive postprocedure DWMRI brain lesions at 2 days after TAVI in potentially protected territories. The first hierarchical secondary outcome was the difference in volume of new lesions after TAVI in potentially protected territories. RESULTS: Among the 100 enrolled patients, mean (SD) age was 80.0 (5.1) years in the filter group (n = 50) and 79.1 (4.1) years in the control group (n = 50), and the mean (SD) procedural risk scores (logistic EuroScores) were 16.4% (10.0%) in the filter group and 14.5% (8.7%) in the control group. For the primary end point, the number of new lesions was lower in the filter group, 4.00 (interquartile range IQR, 3.00-7.25) vs 10.00 (IQR, 6.75-17.00) in the control group (difference, 5.00 IQR, 2.00-8.00; P < .001). For the first hierarchical secondary end point, new lesion volume after TAVI was lower in the filter group (242 mm3 95% CI, 159-353) vs in the control group (527 mm3 95% CI, 364-830) (difference, 234 mm3 95% CI, 91-406; P = .001). Considering adverse events, 1 patient in the control group died prior to the 30-day visit. Life-threatening hemorrhages occurred in 1 patient in the filter group and 1 in the control group. Major vascular complications occurred in 5 patients in the filter group and 6 patients in the control group. One patient in the filter group and 5 in the control group had acute kidney injury, and 3 patients in the filter group had a thoracotomy. CONCLUSIONS AND RELEVANCE: Among patients with severe aortic stenosis undergoing TAVI, the use of a cerebral protection device reduced the frequency of ischemic cerebral lesions in potentially protected regions. Larger studies are needed to assess the effect of cerebral protection device use on neurological and cognitive function after TAVI and to devise methods that will provide more complete coverage of the brain to prevent new lesions. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01833052
BACKGROUND—Learning curves are vigorously discussed and viewed as a negative aspect of adopting new procedures. However, very few publications have methodically examined learning curves in cardiac ...surgery, which could lead to a better understanding and a more meaningful discussion of their consequences. The purpose of this study was to assess the learning process involved in the performance of minimally invasive surgery of the mitral valve using data from a large, single-center experience.
METHODS AND RESULTS—All mitral (including tricuspid, or atrial fibrillation ablation) operations performed over a 17-year period through a right lateral mini-thoracotomy with peripheral cannulation for cardiopulmonary bypass (n=3907) were analyzed. Data were obtained from a prospective database. Individual learning curves for operation time and complication rates (using sequential probability cumulative sum failure analysis) and average results were calculated. A total of 3895 operations by 17 surgeons performing their first minimally invasive surgery of the mitral valve operation at our institution could be evaluated. The typical number of operations to overcome the learning curve was between 75 and 125. Furthermore, >1 such operation per week was necessary to maintain good results. Individual learning curves varied markedly, proving the need for good monitoring or mentoring in the initial phase.
CONCLUSIONS—A true learning curve exists for minimally invasive surgery of the mitral valve. Although the number of operations required to overcome the learning curve is substantial, marked variation exists between individual surgeons. Such information could be very helpful in structuring future training and maintenance of competence programs for this kind of surgery.
Abstract
OBJECTIVES
Non-leaflet resection techniques including loop chordal replacement are being used with increasing frequency, but the long-term results of these techniques are still unknown. The ...aim of this study was to compare the long-term results of loop neochord replacement with leaflet resection techniques in patients undergoing minimally invasive mitral valve (MV) repair for MV prolapse.
METHODS
Between 1999 and 2014, 2134 consecutive MV prolapse patients underwent minimally invasive MV repair with isolated loop (n = 1751; 82.1%) or resection techniques (n = 383, 17.9%) at our institution. Follow-up data were available for 86% of patients with a mean follow-up time of 6.1 ± 4.3 years.
RESULTS
The 30-day mortality was 0.8% for all patients (loop: 0.7%, resection: 1.6%; P = 0.09). Leaflet resection was associated with more moderate or more mitral regurgitation on predischarge echocardiography (P = 0.003). The 1-, 5- and 10-year survival rates were 98 ± 1%, 95 ± 1% and 86 ± 2% for the loop technique versus 97 ± 1%, 92 ± 1% and 81 ± 2% for resection patients, respectively (P = 0.003). Significant predictors for late mortality were MV repair technique (P = 0.004), left ventricular ejection fraction (P < 0.001), age (P < 0.001) and myocardial infarction (P < 0.001). Freedom from MV reoperation at 1, 5 and 10 years was 98 ± 1%, 97 ± 1%, 97 ± 1% and 97 ± 1%, 97 ± 1%, 96 ± 1% for patients operated on with the loop technique and leaflet resection (P = 0.4).
CONCLUSIONS
In our patient cohort, MV repair with loop chordal replacement is associated with less early recurrent mitral regurgitation and very good long-term results when compared to classical leaflet resection techniques for MV prolapse and is therefore an excellent option for such patients.
Abstract
Aims
Transcatheter aortic valve implantation (TAVI) has emerged as established treatment option in patients with symptomatic aortic stenosis. Technical developments in valve design have ...addressed previous limitations such as suboptimal deployment, conduction disturbances, and paravalvular leakage. However, there are only limited data available for the comparison of newer generation self-expandable valve (SEV) and balloon-expandable valve (BEV).
Methods and results
SOLVE-TAVI is a multicentre, open-label, 2 × 2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral TAVI comparing SEV (Evolut R, Medtronic Inc., Minneapolis, MN, USA) with BEV (Sapien 3, Edwards Lifesciences, Irvine, CA, USA). The primary efficacy composite endpoint of all-cause mortality, stroke, moderate/severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days was powered for equivalence (equivalence margin 10% with significance level 0.05). The primary composite endpoint occurred in 28.4% of SEV patients and 26.1% of BEV patients meeting the prespecified criteria of equivalence rate difference −2.39 (90% confidence interval, CI −9.45 to 4.66); Pequivalence = 0.04. Event rates for the individual components were as follows: all-cause mortality 3.2% vs. 2.3% rate difference −0.93 (90% CI −4.78 to 2.92); Pequivalence < 0.001, stroke 0.5% vs. 4.7% rate difference 4.20 (90% CI 0.12 to 8.27); Pequivalence = 0.003, moderate/severe paravalvular leak 3.4% vs. 1.5% rate difference −1.89 (90% CI −5.86 to 2.08); Pequivalence = 0.0001, and permanent pacemaker implantation 23.0% vs. 19.2% rate difference −3.85 (90% CI −10.41 to 2.72) in SEV vs. BEV patients; Pequivalence = 0.06.
Conclusion
In patients with aortic stenosis undergoing transfemoral TAVI, newer generation SEV and BEV are equivalent for the primary valve-related efficacy endpoint. These findings support the safe application of these newer generation percutaneous valves in the majority of patients with some specific preferences based on individual valve anatomy.
Background The goal of this study was to compare the outcome after mitral valve surgery through either standard sternotomy or right lateral minithoracotomy in elderly patients with higher ...perioperative risk. Methods All 1,027 elderly patients (>70 years) who received isolated mitral valve surgery (± tricuspid valve repair) between August 1999 and July 2009 were analyzed for outcome differences due to surgical approach using propensity score matching. The etiology of mitral valve disease was degenerative (83%), endocarditis (6%), rheumatic (10%), and acute ischemic (<1%). Isolated stenosis was rare (3%); most patients had mitral valve regurgitation (72%) or combined mitral valve disease (25%). Results The minimally invasive approach led to longer duration of surgery (186 ± 61 vs 169 ± 59 minutes, p = 0.01), cardiopulmonary bypass time (142 ± 54 vs 102 ± 45 minutes, p = 0.0001), and cross-clamp time (74 ± 44 vs 64 ± 28 minutes, p = 0.015). There were no differences between the matched groups in 30-day mortality (7.7% vs 6.3%, p = 0.82), combined major adverse cardiac and cerebrovascular events (11.2% vs 12.6%, p = 0.86), or other postoperative outcome. Only the number of postoperative arrhythmias and pacemaker implants was higher in the sternotomy group (65.7% vs 50.3%, p = 0.023 and 18.9% vs 10.5%, p = 0.059). Long-term survival was 66% ± 5.6% vs 56 ± 5.5% at 5 years and 35% ± 12% vs 40% ± 7.9% at 8 years, and did not show significant differences. Conclusions Minimally invasive mitral valve surgery through a right lateral minithoracotomy is at least as good and safe as the standard sternotomy approach in elderly patients.
Elderly patients were randomly assigned to CABG with cardiopulmonary bypass (on-pump CABG) or without it (off-pump CABG). At 30 days and at 1 year, there was no significant difference in the ...composite outcome of death, stroke, MI, repeat revascularization, or new renal-replacement therapy.
There is an ongoing debate about the benefits and shortcomings of coronary-artery bypass grafting (CABG) without cardiopulmonary bypass (off-pump CABG). Cardiopulmonary bypass can have detrimental effects.
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Initial trials have shown that off-pump CABG is feasible in selected low-risk patients and offers results similar to those of CABG performed with the conventional on-pump technique (on-pump CABG). In institutions with experience in off-pump CABG, the rate of major adverse events and the rates of complete revascularization and graft patency have been similar to those with on-pump CABG.
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These positive results have been called into question by reports of inferior graft . . .
To compare early and long-term outcomes of minimally invasive surgery (MIS) versus full sternotomy (FS) isolated aortic valve replacement (AVR).
We retrospectively analysed all patients who underwent ...isolated bioprosthetic AVR between 2003 and March 2012 at our institution. Matching was performed based on a propensity score, which was obtained using the output of a logistic regression on relevant preoperative risk factors. Mean follow-up was 3.1±2.7 years (range 0-9.0 years) and was 99.8% complete.
A total of 2051 patients (FS, 1572; MIS, 479) underwent isolated bioprosthetic AVR during the study period. MIS patients were significantly younger (67.8±11.2 vs 70.4±9.4 years) and had a lower logistic EuroSCORE (6.6±6.4 vs 11.2±13.4%, both P<0.001). Propensity matching resulted in 477 matched patients from each group, with no significant differences in any of the preoperative variables. Aortic cross-clamp times were significantly longer in MIS patients (59.4±16.0 vs 56.9±14.6 min, P=0.008). Nonetheless, MIS AVR was associated with a significantly lower incidence of intra-aortic balloon pump usage (0.4 vs 2.1%, P=0.042) and in-hospital mortality (0.4 vs 2.3%, P=0.013), while FS patients had a lower rate of re-exploration for bleeding (1.5 vs 4.2%, P=0.019). Five- and 8-year survival post-AVR was significantly higher in MIS patients (89.3±2.4% and 77.7±4.7% vs 81.8±2.2% and 72.8±3.1%, respectively, P=0.034). Cox regression analysis revealed MIS (hazard ratio: 0.47, 95% confidence interval: 0.26-0.87) as an independent predictor of long-term survival.
MIS AVR is associated with very good early and long-term survival, despite longer myocardial ischaemic times. MIS AVR can be performed safely with results that are at least equivalent to those achieved through an FS.
Background
Transcatheter aortic valve implantation (TAVI) has become standard treatment for elderly patients with symptomatic severe aortic valve stenosis. The ACURATE neo AS study evaluates 30-day ...and 1-year clinical and hemodynamic outcomes in patients treated with the ACURATE
neo
2 valve.
Methods
The primary endpoint of this single-arm multicenter study is 30-day all-cause mortality. Other key endpoints include device performance, echocardiographic measures assessed by an independent core laboratory, and VARC-2 clinical efficacy and safety endpoints through 12 months.
Results
The study enrolled 120 patients (mean age 82.1 ± 4.0 years; 67.5% female, mean baseline STS score 4.8 ± 3.8%). The VARC-2 composite safety endpoint at 30 days occurred in 13.3% of patients. All-cause mortality was 3.3% at 30 days and 11.9% at 1 year. The 30-day stroke rate was 2.5% (disabling stroke 1.7%); there were no new strokes between 30 days and 12 months. The rate of permanent pacemaker implantation was 15.0% (18/120) at 30 days and 17.8% (21/120) at 1 year. No patients required re-intervention for valve-related dysfunction and there were no cases of valve thrombosis or endocarditis. Patients demonstrated significant improvement in mean aortic valve gradient (baseline 38.9 ± 13.1 mmHg, 1 year 7.8 ± 3.5 mmHg;
P
< 0.001 in a paired analysis). In the overall population, paravalvular leak was evaluated at 1 year as none/trace in 60.5%, mild in 37.0%, and moderate in 2.5%; no patients had severe PVL.
Conclusions
One-year outcomes from the ACURATE neo AS study support the safety and performance of TAVI with the ACURATE
neo
2 valve.
Graphic Abstract
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Available for:
EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Abstract
OBJECTIVES
Destruction of the intervalvular fibrous body (IFB) due to infective endocarditis (IE) warrants a complex operation involving radical debridement of all infected tissue, followed ...by double valve replacement (aortic and mitral valve replacement) with patch reconstruction of the IFB. This study assesses the 5-year outcomes in patients undergoing this complex procedure for treatment of double valve IE with IFB involvement.
METHODS
A total of 127 consecutive patients underwent double valve replacement with reconstruction of the IFB for active complex IE between January 1999 and December 2018. Primary outcomes were 3-year and 5-year survival, as well as 5-year freedom from reoperation.
RESULTS
Patients’ mean age was 65.3 ± 12.9 years. Preoperative cardiogenic shock and sepsis were present in 17.3% and 18.9%, respectively. The majority of patients (81.3%) had undergone previous cardiac surgery. Overall, 30-day and 90-day mortality rates were 28.3% and 37.0%, respectively. The 3- and 5-year survival rates for all patients were 45.3 ± 5.1% and 41.8 ± 5.8%, and for those who survived the first 90 postoperative days 75.8 ± 6.1% and 70.0 ± 8.0%, respectively. The overall 5-year freedom from reoperation was 85.1 ± 5.7%. Preoperative predictors for 30-day mortality were Staphylococcus aureus odds ratio (OR) 1.65; P = 0.04 and left ventricular ejection fraction (LVEF) <35% (OR 12.06; P = 0.03), for 90-day mortality acute kidney injury requiring dialysis (OR 6.2; P = 0.02) and LVEF <35% (OR 9.66; P = 0.03) and for long-term mortality cardiogenic shock (hazard ratio 2.46; P = 0.01).
CONCLUSIONS
Double valve replacement with reconstruction of the IFB in patients with complex IE is a challenging operation associated with high morbidity and mortality, particularly in the first 90 days after surgery. Survival and freedom from reoperation rates are acceptable thereafter, particularly considering the severity of disease and complex surgery.
Objectives
We present 1‐year outcomes of the post‐market registry of a next‐generation transcatheter heart valve used for aortic regurgitation (AR).
Background
Transcatheter aortic valve replacement ...(TAVR) is routine in high‐risk patients with aortic stenosis but is not recommended for AR. The JenaValve™ (JenaValve Technology GmbH, Munich, Germany) overcomes technical challenges in AR patients through a leaflet clipping mechanism.
Methods
The JenaValve EvalUation of Long Term Performance and Safety In PaTients with SEvere Aortic Stenosis oR Aortic Insufficiency (JUPITER) Registry is a European study to evaluate safety and effectiveness of this THV. From 2012‐2015, 30 patients with AR were enrolled.
Results
Mean age was 74.4 ± 9.3 years. Procedural success was 96.7% (29/30). One patient was converted to open surgery. No annular rupture or coronary ostia obstruction occurred. Mortality at 30 days was 10.0% (3/30). Combined safety endpoint was met in 13.3% (4/30). Paravalvular regurgitation was not present/trivial in 84.6% (22/26) and mild in 15.4% (4/26). Rate of permanent pacemaker implantation was 3.8% (1/26). One‐year Kaplan‐Meier survival was 79.9%, one‐year combined efficacy was 73.1% (19/30). No further strokes were observed during 1 year of follow‐up.
Conclusions
The JenaValve overcomes technical challenges of TAVR in AR through a clipping mechanism. We report satisfactory outcomes of a multicenter registry using the JenaValve for predominant AR, as rate of THV embolization, residual AR and permanent pacemaker implantation was low. One‐year results using the JenaValve for AR encourage its use for this indication.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
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