David Holzhey

The German Aortic Valve Registry (GARY): in-hospital outcome

Background Aortic stenosis is a frequent valvular disease especially in elderly patients. Catheter-based valve implantation has emerged as a valuable treatment approach for these patients being either at very high risk for conventional surgery or even deemed inoperable. The German Aortic Valve Registry (GARY) provides data on conventional and catheter-based aortic procedures on an all-comers basis. Methods and results A total of 13 860 consecutive patients undergoing repair for aortic valve disease [conventional surgery and transvascular (TV) or transapical (TA) catheter-based techniques] have been enrolled in this registry during 2011 and baseline, procedural, and outcome data have been acquired. The registry summarizes the results of 6523 conventional aortic valve replacements without (AVR) and 3464 with concomitant coronary bypass surgery (AVR + CABG) as well as 2695 TV AVI and 1181 TA interventions (TA AVI). Patients undergoing catheter-based techniques were significantly older and had higher risk profiles. The stroke rate was low in all groups with 1.3% (AVR), 1.9% (AVR + CABG), 1.7% (TV AVI), and 2.3% (TA AVI). The in-hospital mortality was 2.1% (AVR) and 4.5% (AVR + CABG) for patients undergoing conventional surgery, and 5.1% (TV AVI) and AVI 7.7% (TA AVI). Conclusion The in-hospital outcome results of this registry show that conventional surgery yields excellent results in all risk groups and that catheter-based aortic valve replacements is an alternative to conventional surgery in high risk and elderly patients.

Aortic valve calcium scoring is a predictor of significant paravalvular aortic insufficiency in transapical-aortic valve implantation‡

OBJECTIVE Transapical-aortic valve implantation (TA-AVI) has evolved as routine for selected high-risk patients. However, paravalvular leaks >1+ remain an unsolved issue using current generations of transcatheter valve devices. The purpose of this study was to investigate the impact of native aortic valve calcification on paravalvular leaks and outcomes using the Edwards SAPIEN™ prosthesis. METHODS One hundred and twenty consecutive patients (out of 307 TA-AVIs) with preoperative computed tomography aged 82.6 ± 6.2 years, 75.0% female were included. Implanted prosthetic valve sizes were 23 mm (n = 31) and 26 mm (n = 89), respectively. Mean logistic European System for Cardiac Operative Risk Evaluation-Score was 30.1 ± 15.5% and mean Society of Thoracic Surgeons-Score was 12.8 ± 7.9%. Electrocardiographic (ECG)-gated cardiac computed tomography allowed to quantify the amount of calcification of aortic valve leaflets using a scoring analogous to the Agatston calcium scoring of coronary arteries [Aortic Valve Calcium Scoring (AVCS)]. Paravalvular leaks were assessed intraoperatively by echocardiography and root angiography. RESULTS All valves were implanted successfully. The mean AVCS in patients without paravalvular leaks (n = 66) was 2704 ± 1510; with mild paravalvular leaks (n = 31) was 3804 ± 2739 (P = 0.05); and with moderate paravalvular leaks (n = 4) was 7387 ± 1044 (P = 0.002). There was a significant association between the AVCS and paravalvular leaks [odds ratio (OR; per AVCS of 1000), 11.38; 95% confidence interval (CI) 2.33-55.53; P = 0.001)] and a trend towards a higher incidence of new pacemaker implantation (OR 1.27; 95% CI 0.85-1.89; P = 0.26). No association was found to 30-day mortality, major cardiac events and stroke rate (OR 1.05; 95% CI 0.84-1.32; P = 0.68; OR 0.92; 95% CI 0.68-1.25; P = 0.57 and OR 0.90; 95% CI 0.41-1.96; P = 0.79, respectively). Overall 30-day mortality was 14.2%. CONCLUSION Severe native valve calcifications are predictive for postoperative relevant paravalvular leak. AVCS prior to TA-AVI might serve as an additional tool to reconsider the TAVI indication to reduce the risk of paravalvular leaks especially in so-called operable patients.

The German Aortic Valve Registry: 1-year results from 13 680 patients with aortic valve disease †

OBJECTIVES The German Aortic Valve Registry (GARY) seeks to provide information on a real-world, all-comers basis for patients undergoing aortic valve interventions. This registry comprises patients undergoing the complete spectrum of transcutaneous and conventional surgical aortic valve interventions. The aim of this study was to use the GARY registry to evaluate conventional and catheter-based aortic valve interventions in several risk groups. METHODS A total of 13 860 consecutive patients undergoing intervention for aortic valve disease [conventional aortic valve replacement (AVR) or transvascular/transapical TAVR (TV-/TA-TAVR)] were enrolled in 78 German centres in 2011. Baseline, procedural and outcome data, including quality of life, were acquired up to 1 year post-intervention. Vital status at 1 year was known for 98.1% of patients. RESULTS The 1-year mortality rate was 6.7% for conventional AVR patients (n = 6523) and 11.0% for patients who underwent AVR with coronary artery bypass grafting (n = 3464). The 1-year mortality rate was 20.7 and 28.0% in TV- and TA-TAVR patients, respectively (n = 2695 and 1181). However, if patients were stratified into four risk groups by means of the EuroSCORE and the German AV Score, the highest risk cohorts showed the same mortality at 1 year with either therapy. More than 80% of patients in all groups were in the same or better state of health at 1 year post-intervention and were satisfied with the procedural outcome. CONCLUSIONS Conventional AVR surgery yields excellent results after 1 year in lower-risk patients. Catheter-based AVR is a good alternative in high-risk and elderly patients.

Learning Minimally Invasive Mitral Valve Surgery A Cumulative Sum Sequential Probability Analysis of 3895 Operations From a Single High-Volume Center

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. # Clinical Perspective {#article-title-25}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.

Transapical Aortic Valve Implantation

Background— Transapical aortic valve implantation has evolved to a reproducible therapeutic option for high-risk patients. The aim of the present study was to evaluate our learning experience over 4 years and to analyze outcome-related risk factors. Methods and Results— A total of 299 patients who received transapical aortic valve implantation between February 2006 and January 2010 with the Edwards SAPIEN transcatheter prosthesis were analyzed according to early experience (EE; patients 1 to 150) and recent experience (RE; patients 151 to 299). Patients consistently demonstrated high risk scores, and major perioperative parameters were comparable between the 2 groups. RE patients had a significantly higher logistic EuroSCORE (RE 33.2±17.2, EE 29.4±14; P=0.039) but a significantly lower STS (Society of Thoracic Surgeons) score (RE 11.4±7.5, EE 13.5±7.8; P=0.019). Use of contrast dye (EE 104±78 mL, RE 93±46 mL) and the need to perform a balloon redilation were significantly reduced in the RE group. Thirty-day mortality decreased from 11.3% to 6.0%, and 1-year mortality improved significantly from 30.7% (EE) to 21.5% in the RE patients (P=0.047). Multivariate logistic regression analysis revealed reduced vital capacity (<70%) and concomitant preoperative mitral regurgitation >1+ as the only independent predictors of 30-day mortality. Classic variables such as age, logistic EuroSCORE >30%, and STS score >15% failed to predict mortality. Conclusions— Recent results with transapical aortic valve implantation indicate a progressive improvement in outcomes despite an unchanged patient risk profile, which reflects a significant learning curve that includes a better understanding of optimal patient selection. Classic surgical risk factors fail to predict outcome, which indicates the need for new transapical aortic valve implantation–specific risk scores.

Minimally Invasive Hybrid Coronary Artery Revascularization

BACKGROUND Here we report the short- and long-term results of a minimally invasive hybrid approach in 117 patients. METHODS From 1996 to 2007, revascularization of the left anterior descending artery was performed in 1,696 patients by minimally invasive direct coronary artery bypass grafting (MIDCAB), in 89 patients by beating-heart totally endoscopic coronary artery bypass grafting (TECAB) and in 30 patients by arrested-heart TECAB. Of these patients, 117 were scheduled for a hybrid procedure. Revascularization of the left anterior descending artery was performed by either MIDCAB (107 patients), beating-heart TECAB (8 patients) or arrested-heart TECAB (2 patients). Percutaneous coronary intervention of vessels other than the left anterior descending artery was performed 4 to 6 weeks preoperatively (53 cases), intraoperatively (5 cases), or 2 to 45 days postoperatively (59 cases). Demographic data, perioperative outcome, and annual follow-up were obtained from all patients. RESULTS Minimally invasive bypass and stenting could be completed in all patients. Two high-risk patients (1.9%) died postoperatively. Follow-up of all patients adds up to 208 patient-years. Eight patients died during follow-up. Kaplan-Meier survival was 92.5% (95% confidence interval [CI]: 86.5% to 98.4%) at 1 year and 84.8% (95% CI: 73.5% to 94.9%) at 5 years. Follow-up angiogram of symptomatic patients showed 1 bypass occlusion and 5 in-stent restenosis with need for reintervention. Freedom from major adverse cardiac and cerebral events (including reintervention) and angina was 85.5% (95% CI: 76.9% to 94.1%) at 1 year and 75.5% (95% CI: 62.7% to 87.3%) at 5 years. CONCLUSIONS Minimally invasive hybrid coronary revascularization is a safe approach with good long-term results. It should be performed in selected patients at centers with considerable experience in minimally invasive bypass surgery and requires close cooperation between cardiologists and surgeons.

Risk of acute kidney injury after minimally invasive transapical aortic valve implantation in 270 patients

OBJECTIVE Contrast agent is a potential risk factor for acute kidney injury (AKI). Little is known about the incidence of contrast-induced nephropathy (CIN) after trans-apical aortic valve implantation (TA-AVI) and on the impact of contrast exposure during preoperative computed tomography (CT) scan and cardiac catheterization. METHODS A total of 270 consecutive high-risk patients received TA-AVI for symptomatic aortic valve stenosis during a 3-year period. Different preoperative, peri-procedural, and postoperative variables were analyzed by uni- and multivariate logistic regression concerning incidence of early (<7 days) AKI and need for renal replacement therapy (RRT). Nine patients on chronic preoperative dialysis were excluded. RESULTS Mean age was 82 ± 5.8 years, 71% were female. LogEuroSCORE (European System for Cardiac Operative Risk Evaluation) and STS Score were 31.4 ± 15.6% and 12.1 ± 7.4%, respectively. Preoperative estimated glomerular filtration rate (eGFR) <60 ml min(-1) was present in 35.2%. CT scan and cardiac catheterization within 7 days before TA-AVI were performed in 43.7% and 20.3% of the patients and were associated with a mean contrast-agent exposition of 110 ± 21 ml for CT scans and 91 ± 65 ml for cardiac catheterization. Regarding the postoperative renal outcome, an improved or at least stable eGFR was seen in more than 50% of the patients. Intra-operative contrast-agent application was 99 ± 64 ml and correlated significantly to the development of postoperative AKI and need for RRT (p=0.013 and p=0.003). Postoperative RRT was required in 15.7%. Chronic renal insufficiency (odds ratio (OR)=6.8, p=0.025) and number of blood transfusions (OR=8.8, p=0.009) were independent risk factors for RRT. Postoperative AKI occurred in 16.1% and intra-operative contrast-agent burden >99 ml (OR=2.3, p=0.038), new thrombocytopenia (OR=4.4, p=0.005) and pathological leucocyte count (OR=2.8, p=0.009) were independent risk factors for this event. Early (within 1-7 days before TA-AVI) preoperative CT and cardiac catheterization did not significantly increase incidence of RRT or AKI. Short-term and long-term survival was explicitly lower in the AKI and in the RRT groups (p<0.001 each). CONCLUSIONS GFR improves after TA-AVI. Postoperative AKI and RRT depend on the amount of intra-operative contrast agent. These results strongly support the need for intra-operative tools to reduce contrast-agent exposition during TA-AVI.

Does Reasonable Incomplete Surgical Revascularization Affect Early or Long-Term Survival in Patients With Multivessel Coronary Artery Disease Receiving Left Internal Mammary Artery Bypass to Left Anterior Descending Artery?

Background— The objective was to evaluate the impact of complete revascularization (CR) versus reasonable incomplete surgical revascularization (IR) in others than left anterior descending artery territory on early and late survival in patients with multivessel coronary artery disease (CAD). Methods and Results— During a 7-year period, 8.806 consecutive patients with multivessel CAD affecting the proximal left anterior descending artery or left main stem underwent sternotomy for isolated coronary artery bypass grafting including left internal mammary artery–left anterior descending artery bypass. A total of 936 patients (10.6%) had IR of the circumflex or right coronary artery territory. IR was based on the traditional classification. Follow-up was 3.5±2.2 years. Patient groups were comparable regarding age (CR 67.1 versus IR 67.6 years), ejection fraction (57.2% versus 57.5%), and logEuroscore (4.5% versus 4.5%). Patients receiving IR presented with more complex CAD. Mean number of distal anastomoses was 3.0±0.8 CR versus 2.4±0.6 IR. Operation time (176 versus 187 minutes) and cross-clamp time (52 versus 56 minutes) were longer in the IR group (P<0.001). Hospital mortality was 3.3% CR versus 3.2% IR (P=0.520). Independent risk factors for hospital mortality were age, pulmonary hypertension, chronic obstructive pulmonary disease, peripheral vascular disease, and emergency indication, but not IR (P=0.922). Arterial revascularization was protective. Cumulative survival at 1-year was 93.1% CR versus 93.6% IR and at 5 years 82.2 CR versus 80.9% IR (P=0.457). Conclusions— In presence of left internal mammary artery-to-left anterior descending artery bypass, reasonable IR of the circumflex or right coronary artery territory did not adversely affect early or long-term survival in patients with multivessel CAD. In patients presenting with 1 poor target vessel; however, IR is a good therapeutic option and the benefit of CR should be balanced against the risks.

Effect of a Cerebral Protection Device on Brain Lesions Following Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis: The CLEAN-TAVI Randomized Clinical Trial

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.

Minimally Invasive Versus Sternotomy Approach for Mitral Valve Surgery in Patients Greater Than 70 Years Old: A Propensity-Matched Comparison

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.