Novel concept of routine total arterial coronary bypass grafting through a left anterior approach avoiding sternotomy.

Coronary artery bypass grafting (CABG) via full sternotomy remains a very invasive procedure, often requiring prolonged recovery of the patient. We describe a novel, less invasive approach for totally arterial CABG via a small left anterior thoracotomy in a pilot series of 20 unselected patients. From January to March 2020, 20 consecutive patients (mean age 65.9 ± 9.2 years, 100% male, STS-score: 1.6 ± 2) underwent CABG using only arterial conduits via a small left anterior thoracotomy. Patients were operated on cardiopulmonary bypass with peripheral cannulation and transthoracic aortic cross-clamping. Pulling tapes encircling the great vessels, the arrested empty heart was rotated and moved within the pericardium to enable conventional anastomotic techniques especially on lateral and inferior wall coronary targets. In all patients, left internal mammary artery and radial artery were utilized for bypass with 3.3 ± 0.7 distal coronary anastomoses per patient. Anterior, lateral, and inferior wall territories were revascularized in 100%, 85%, and 70% of patients, respectively. Complete anatomical revascularization was achieved in 95% of patients. ICU stay was 1 day in 17 patients, and 14 of patients left the hospital within 8 days. There was no hospital death, no stroke, no myocardial infarction, and no repeat revascularization. In this pilot series of 20 patients, minimally invasive, totally arterial CABG with avoidance of sternotomy was technically feasible with favorable patient outcomes.

Underweight is associated with inferior short and long-term outcomes after MitraClip implantation: Results from the German TRAnscatheter mitral valve interventions (TRAMI) registry.

BACKGROUND: Underweight and obesity represent classical risk factors for adverse outcome in patients treated for cardiovascular disease. AIMS: The current analysis examines the impact of underweight, overweight and obesity on intra-hospital, short and long-term outcomes in patients treated by MitraClip therapy. METHODS AND RESULTS: From August 2010 until July 2013, 799 patients (age 75.3 ±â€¯8.6 years, male gender 60.7%, median logistic EuroSCORE 20% [12; 31], functional mitral regurgitation (MR): 69.3%) were prospectively enrolled into the multicenter German Transcatheter Mitral Valve Interventions registry. Patients were stratified according to body mass index (BMI) into 4 groups: BMI <20 kg/m2 (underweight), BMI 20.0 to <25.0 kg/m2 (normal weight, reference group), BMI 25.0 to <30.0 kg/m2 (overweight) and BMI ≥30 kg/m2 (obese). Significant increased rates of procedural failure, transfusion/bleeding, sepsis or multiorgan failure and low cardiac output failure were found for underweight patients only. Kaplan-Meier survival curves demonstrated inferior survival for underweight patients, but comparable outcomes for all other patients (global log rank test, P < .01). Multivariable Cox-regression analysis (adjusted for age, gender, creatinine ≥1.5 mg/dL, diabetes, left ventricular ejection fraction <30% and chronic obstructive pulmonary disease) confirmed underweight (as compared to normal weight) as an independent risk factor of death (hazard ratio [HR]: 1.58, 95% confidence interval (CI): 1.01-2.46, P = .044) and overweight as protective against death (HR: 0.71; 95%-CI: 0.55-0.93; P = .011). CONCLUSIONS: Compared to other weight groups, underweight patients undergoing MitraClip implantation are exposed to increased rates of procedural failure, bleeding and low cardiac output as well as increased short- and long-term mortality rates and should therefore be carefully discussed in the heart-team.

Incidence and outcome of peri-procedural transcatheter heart valve embolization and migration: the TRAVEL registry (TranscatheteR HeArt Valve EmboLization and Migration).

AIMS: Peri-procedural transcatheter valve embolization and migration (TVEM) is a rare but potentially devastating complication of transcatheter aortic valve implantation (TAVI). We sought to assess the incidence, causes, and outcome of TVEM in a large multicentre cohort. METHODS AND RESULTS: We recorded cases of peri-procedural TVEM in patients undergoing TAVI between January 2010 and December 2017 from 26 international sites. Peri-procedural TVEM occurred in 273/29 636 (0.92%) TAVI cases (age 80.8 ± 7.3 years; 53.8% female), of which 217 were to the ascending aorta and 56 to the left ventricle. The use of self-expanding or first-generation prostheses and presence of a bicuspid aortic valve were independent predictors of TVEM. Bail-out measures included repositioning attempts using snares or miscellaneous tools (41.0%), multiple valve implantations (83.2%), and conversion to surgery (19.0%). Using 1:4-propensity matching, we identified a cohort of 235 patients with TVEM (TVEMPS) and 932 patients without TVEM (non-TVEMPS). In the matched cohort, all-cause mortality was higher in TVEMPS than in non-TVEMPS at 30 days (18.6% vs. 4.9%; P < 0.001) and after 1 year (30.5% vs. 16.6%; P < 0.001). Major stroke was more frequent in TVEMPS at 30 days (10.6% vs. 2.8%; P < 0.001), but not at 1 year (4.6% vs. 1.9%; P = 0.17). The need for emergent cardiopulmonary support, major stroke at 30 days, and acute kidney injury Stages 2 and 3 increased the risk of 1-year mortality, whereas a better renal function at baseline was protective. CONCLUSION: Transcatheter valve embolization and migration occurred in approximately 1% and was associated with increased morbidity and mortality.

Meta-analysis of drug eluting stents compared with bare metal stents in high bleeding risk patients undergoing percutaneous coronary interventions.

OBJECTIVES: To determine the efficacy and safety of drug-eluting stents (DESs) and bare metal stents (BMSs) when used with short or tailored dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients. BACKGROUND: DES have been shown to reduce target lesion revascularization (TLR) as well as stent thrombosis (ST) compared to BMS in patients undergoing percutaneous coronary intervention (PCI). However, patients at HBR continue to receive BMS given the fear of bleeding or ST from premature discontinuation of DAPT in patients receiving DES. METHODS: We performed a meta-analysis of randomized controlled trials by performing systematic search for studies comparing DES with BMS in HBR patients using PUBMED, MEDLINE, and Cochrane Central, reported until March 1, 2018. RESULTS: Three randomized controlled studies met the inclusion criteria with total of 4,460 patients; 50% received DES. Major adverse cardiovascular event (MACE); composite of death, myocardial infarction (MI), and TLR, at 1 year was significantly lower (RR = 0.63, 95% CI 0.50-0.80) in DES group compared to BMS. This difference was primarily driven by lower TLR (RR = 0.46, 95% CI 0.35-0.61) in DES group. Definite or probable ST (RR = 0.59, 95% CI = 0.32-1.08) and major (RR = 0.94, 95% CI = 0.74-1.20) bleeding were similar. CONCLUSIONS: DES was associated with lower MACE without increased risk of bleeding or ST compared to BMS when used with short or tailored DAPT in patients with HBR.

Incidence and outcomes of emergent cardiac surgery during transfemoral transcatheter aortic valve implantation (TAVI): insights from the European Registry on Emergent Cardiac Surgery during TAVI (EuRECS-TAVI).

Aims: Life-threatening complications occur during transcatheter aortic valve implantation (TAVI) which can require emergent cardiac surgery (ECS). Risks and outcomes of patients needing ECS during or immediately after TAVI are still unclear. Methods and results: Incidence, risk factors, management, and outcomes of patients requiring ECS during transfemoral (TF)-TAVI were analysed from a contemporary real-world multicentre registry. Between 2013 and 2016, 27 760 patients underwent TF-TAVI in 79 centres. Of these, 212 (0.76%) patients required ECS (age 82.4 ± 6.3 years, 67.5% females, logistic EuroSCORE: 17.1%, STS-score 5.8%). The risk of ECS declined from 2013 (1.07%) to 2014 (0.70%) but remained stable since. Annual TF-TAVI numbers have more than doubled from 2013 to 2016. Leading causes for ECS were left ventricular perforation by the guidewire (28.3%) and annular rupture (21.2%). Immediate procedural mortality (<72 h) of TF-TAVI patients requiring ECS was 34.6%. Overall in-hospital mortality was 46.0%, and highest in case of annular rupture (62%). Independent predictors of in-hospital mortality following ECS were age > 85 years [odds ratio (OR) 1.87, 95% confidence interval (95% CI) (1.02-3.45), P = 0.044], annular rupture [OR 1.96, 95% CI (0.94-4.10), P = 0.060], and immediate ECS [OR 3.12, 95% CI (1.07-9.11), P = 0.037]. One year of survival of the 114 patients surviving the in-hospital period was only 40.4%. Conclusion: Between 2014 and 2016, the need for ECS remained stable around 0.7%. Left ventricular guidewire perforation and annular rupture were the most frequent causes, accounting for almost half of ECS cases. Half of the patients could be salvaged by ECS-nevertheless, 1 year of all-cause mortality was high even in those ECS patients surviving the in-hospital period.

Outcomes of transfemoral transcatheter aortic valve implantation at hospitals with and without on-site cardiac surgery department: insights from the prospective German aortic valve replacement quality assurance registry (AQUA) in 17 919 patients.

AIMS: Performing transcatheter aortic valve implantation (TAVI) at hospitals with only cardiology department but no cardiac surgery (CS) on-site is at great odds with current Guidelines. METHODS AND RESULTS: We analysed data from the official, prospective German Quality Assurance Registry on Aortic Valve Replacement to compare characteristics and in-hospital outcomes of patients undergoing transfemoral TAVI at hospitals with (n = 75) and without CS departments (n = 22). An interdisciplinary Heart Team was established at all centres (internal staff physicians at hospitals with on-site CS; in-house cardiologists and visiting cardiac surgical teams from collaborating hospitals at non-CS hospitals). In 2013 and 2014, 17 919 patients (81.2 ± 6.1 years, 55% females, German aortic valve (GAV) score 2.0 5.6 ± 5.8%, logistic EuroSCORE I 21.1 ± 15.4%) underwent transfemoral TAVI in Germany: 1332 (7.4%) at hospitals without on-site CS department. Patients in non-CS hospitals were older (82.1 ± 5.8 vs. 81.1 ± 6.1 years, P < 0.001), with more frequent co-morbidities. Predicted mortality risks per GAV-score 2.0 (6.1 + 5.5 vs. 5.5 ± 5.9%, P < 0.001) and logEuroSCORE I (23.2 ± 15.8 vs. 21.0 ± 15.4%, P < 0.001) were higher in patients at non-CS sites. Complications, including strokes (2.6 vs. 2.3%, P = 0.452) and in-hospital mortality (3.8 vs. 4.2%, P = 0.396), were similar in both groups. Matched-pair analysis of 555 patients in each group with identical GAV-score confirmed similar rates of intraprocedural complications (9.2 vs. 10.3%, P = 0.543), strokes (3.2% for both groups, P = 1.00), and in-hospital mortality (1.8 vs. 2.9%, P = 0.234). CONCLUSION: Although patients undergoing TAVI at hospitals without on-site CS department were older and at higher predicted perioperative death risk, major complications, and in-hospital mortality were not statistically different, suggesting the feasibility and safety of Heart Team-based TAVI at non-CS sites. These findings need confirmation in future randomized study.

One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from the German transcatheter mitral valve interventions registry.

AIMS: The transcatheter mitral valve interventions (TRAMI) registry was established in order to assess safety and efficacy of catheter-based mitral valve interventional techniques in Germany, and prospectively enrolled 828 MitraClip patients (median age 76 years, median log. EuroSCORE I 20.0%) between August 2010 and July 2013. We present the 1-year outcome in this MitraClip cohort-which is the largest published to date. METHODS AND RESULTS: Seven forty-nine patients (90.5%) were available for 1-year follow-up and included in the following analyses. Mortality, major adverse cardiovascular event rates, and New York Heart Association (NYHA) classes were recorded. Predictors of 1-year mortality were identified by multivariate analysis using a Cox regression model with stepwise forward selection. The 1-year mortality was 20.3%. At 1 year, 63.3% of TRAMI patients pertained to NYHA functional classes I or II (compared with 11.0% at baseline), and self-rated health status (on EuroQuol visual analogue scale) also improved significantly by 10 points. Importantly, a significant proportion of patients regained the complete independence in self-care after MitraClip implantation (independence in 74.0 vs. 58.6% at baseline, P = 0.005). Predictors of 1-year mortality were NYHA class IV (hazard ratio, HR 1.62, P = 0.02), anaemia (HR 2.44, P = 0.02), previous aortic valve intervention (HR 2.12, P = 0.002), serum creatinine ≥1.5 mg/dL (HR 1.77, P = 0.002), peripheral artery disease (HR 2.12, P = 0.0003), left ventricular ejection fraction <30% (HR 1.58, P = 0.01), severe tricuspid regurgitation (HR 1.84, P = 0.003), and procedural failure (defined as operator-reported failure, conversion to surgery, failure of clip placement, or residual post-procedural severe mitral regurgitation) (HR 4.36, P < 0.0001). CONCLUSIONS: Treatment of significant MR with MitraClip resulted in significant clinical improvements in a high proportion of TRAMI patients after 12 months. In the TRAMI cohort, the failure of procedural success exhibited the highest hazard ratio concerning the prediction of 1-year mortality.

Incidence and Clinical Impact of Stroke Complicating Transcatheter Aortic Valve Implantation: Results From the German TAVI Registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has emerged as a safe and effective treatment for patients with severe, symptomatic aortic valve stenosis at high surgical risk over the last years. However, besides its minimal invasive character, TAVI still is an invasive procedure usually performed in a population, carrying a substantial risk for vascular complications, like stroke. Stroke is known to be a rare but serious complication of transvascular interventions in clinical practice, which is associated with high morbidity and mortality rates. Despite broad clinical research in many fields of TAVI over the last years, only sparse data still exist on the incidence and clinical risk factors of stroke complicating TAVI in clinical practice today. METHODS: We analyzed data of 1.413 TAVIs, which were enrolled at 30 sites into the prospective and multicenter German TAVI Registry from January 2009 until June 2010. RESULTS: The overall incidence of cerebrovascular events complicating TAVI was 3.2% (n = 45/1.413) in a real-world population today. 40% of all cerebrovascular events were classified as transient ischemic attacks (TIA) with symptoms lasting < 24 hr (18/45) and 60% were classified as stroke with symptoms persisting > 24 hr (27/45). All strokes complicating TAVI of 50% were classified as major strokes leading to notable disability in patients, who survive this complication (Modified Ranking Scale 3-6). In-hospital mortality rate in patients with stroke/TIA was 28.9%, compared to 6.9% in patients without stroke/TIA and 1-year mortality rate 46.7% versus 18.6%, respectively. In multivariate analysis, prior stroke and renal impairment were found as the only independent predictors for stroke complicating TAVI. CONCLUSIONS: Stroke complicating TAVI is a serious complication with a clinically relevant incidence even in daily practice leading to a fivefold increase in 30-day-mortality rate, as well as a significant increase in morbidity and disability in patients, who survive this devastating complication. Further research is needed to identify risk factors and ways to reduce stroke after TAVI. © 2016 Wiley Periodicals, Inc.

Thoracic Endovascular Repair of Complicated Penetrating Aortic Ulcer: An 11-Year Single-Center Experience.

PURPOSE: To analyze an 11-year single-center experience of treating complicated penetrating aortic ulcer (PAU) using thoracic endovascular aortic repair (TEVAR). METHODS: This study included 63 consecutive patients (mean age 69.1±11.5 years; 40 men) with complicated PAU (42 symptomatic, 22 with rupture) who underwent TEVAR between 2002 and 2013. The PAUs were located in the aortic arch (n=11), the descending thoracic aorta (n=43), and the thoracoabdominal aorta (n=9). RESULTS: TEVAR was performed within 14 days of diagnosis in 33 (52.3%) cases (19 ruptures treated immediately); the other 30 (47.6%) patients had an average interval between diagnosis and intervention of 40±39 days. Technical success was 98.4% (62/63). One patient had a type I endoleak after stent-graft repair of a PAU in the aortic arch without great vessel transposition; another procedure was required for carotid-subclavian bypass and proximal stent-graft extension. No patient experienced spinal cord ischemia after TEVAR. Five (7.9%) patients died in-hospital; 3 had severe cardiac complications, 1 died from complications of aortic rupture, and the other succumbed to septic shock. Mean follow-up was 45.6±47.2 months, during which 12 (19.0%) patients needed a secondary intervention because of late endoleaks (n=4, 6.3%) or new complications due to disease progression. Multivariate analysis indicated that a PAU depth >15 mm was an independent predictor of mortality (hazard ratio 6.92, p=0.03). In the biomarker analysis, symptomatic patients had significantly higher D-dimer and troponin levels compared to asymptomatic patients [559.5±460.7 vs 283.2±85.2 µg/L (p=0.016) and 0.22±0.61 vs 0.02±0.03 ng/mL (p=0.04), respectively]. CONCLUSION: Patients with PAU suffer from underlying severe atherosclerotic disease and have a significant number of cardiovascular comorbidities that lead to relevant mortality and morbidity after TEVAR. As a PAU diameter >15 mm represented high risk for disease progression, these patients may be candidates for early intervention. D-dimer levels may help identify patients at risk and with progression of PAU.

Dynamic MR angiography in acute aortic dissection.

BACKGROUND: To evaluate the benefit (additional flow information), image quality, and diagnostic accuracy of a dynamic magnetic resonance angiography (MRA) combining high spatial and temporal resolution for the preinterventional assessment of acute aortic dissection. METHODS: Nineteen patients (12 men, 7 women; aged 32-78 years) with acute aortic dissection underwent contrast-enhanced four-dimensional (4D) MRA and 3D conventional high-resolution MRA (3D MRA) within one examination on a 1.5 Tesla MR system. Both MRA datasets for each patient were evaluated and compared for image quality and visualization of vascular details on a 5-point scale (5 = excellent image quality, 1 = nondiagnostic image quality). In addition, presence and relevance of additional hemodynamic information (flow direction and organ perfusion delay) gained by dynamic MRA were assessed. RESULTS: Conventional 3D MRA provided significantly higher values for image quality of the aorta and aortic side branches compared with dynamic MRA (aorta: 4.3 versus 3.3; P = 0.006 side branches: 4.2 versus 3.3; P = 0.02). However, in 10 of the 19 patients (53%) the additionally available information on flow dynamics due to dynamic MRA (e.g., delayed perfusion of parenchymal organs) led to a change in therapy planning and realization. CONCLUSION: Dynamic MRA is a technique that combines functional flow and morphological information. Thus, the combination of 3D and dynamic MRA provides all requested information for treatment planning in patients suffering from acute aortic dissection.

Thoracic aortic aneurysm expansion due to late distal stent graft-induced new entry.

OBJECTIVES: This study analyzed the mechanism and risk factors of thoracic aortic aneurysm expansion due to late distal stent graft-induced new entry (dSINE). BACKGROUND: This late complication of thoracic endovascular aneurysm repair (TEVAR) for aortic dissection is under-recognized but potentially life-threatening. METHODS: In 142 patients who underwent TEVAR with endovascular entry sealing for acute and chronic aortic type B dissection, using commercially available straight (nontapered) stent-grafts, we examined the oversizing rate, the aortic taper ratio, and the need for reintervention. RESULTS: Nine of 142 patients developed thoracic aortic aneurysm expansion due to dSINE after TEVAR. The median follow-up was 47.5 ± 37.4 months. There was a significant difference in the distal stent-aorta angle between the patients with and without dSINE (149.08 ± 15.09° vs. 166.72 ± 12.47°, P < 0.005). Patients with dSINE showed a significantly higher taper ratio of the true lumen of the aorta (40.9 ± 14.13% vs. 25.36 ± 20.2%, P < 0.05). There was also a significant difference in the oversizing of the stent-graft in the distal landing zone (95.88 ± 49.3% vs. 55.94 ± 36.23%, P < 0.01). All patients with dSINE underwent a secondary endograft procedure without any complications or deaths. In 7 cases we used a custom-made, highly tapered stent-graft. CONCLUSIONS: Lifelong follow-up of patients is mandatory after TEVAR. A stent-graft with a tapered design should be used in aortic dissection to avoid oversizing and devastating late complications.

Risk and outcomes of complications during and after MitraClip implantation: Experience in 828 patients from the German TRAnscatheter mitral valve interventions (TRAMI) registry.

AIMS: To analyze risk and outcomes of complications during and after MitraClip implantation using multicenter data from the prospective German Transcatheter Mitral Valve Interventions (TRAMI) registry. METHODS AND RESULTS: Data of 828 patients (mean age: 76.0 [71-81] years, 327 (40%) females) undergoing MitraClip implantation in Germany between 2010 and 2013 were analyzed. Most patients (85%) underwent elective procedures with on average implantation of 1.4 ± 0.6 clips. Emergent cardiac surgery was not required; a single patient died intraoperatively. During the in-hospital period, complications occurred in 215 (25.9%) patients, of which 106 (12.8%) were considered major. Major bleeding complications were among the most frequent major complications (7.4%), while rates of pericardial tamponade (1.9%) and clip-specific complications (embolization: 0%, partial clip detachment: 1.9%) were low. In-hospital death, stroke or myocardial infarction (MACCE) occurred in 2.2, 0.9, and 0% patients, respectively. Patients with complications appeared to be older and more critically ill pre-interventionally; in-hospital mortality was significantly higher as compared to those without procedural complications. CONCLUSIONS: MitraClip implantation appears to be a safe treatment option with low rates of MACCE and clip-specific complications. Nevertheless, MitraClip therapy is not without complications. Careful patient selection and improvements in preventing peri-procedural bleeding have the potential of reducing post-procedural complications and improving outcomes.

Percutaneous mitral valve repair with the MitraClip system according to the predicted risk by the logistic EuroSCORE: preliminary results from the German Transcatheter Mitral Valve Interventions (TRAMI) Registry.

OBJECTIVE: To evaluate in-hospital and short-term outcomes of percutaneous mitral valve repair according to patients' logistic EuroSCORE (logEuroSCORE) in a multicenter registry BACKGROUND: The logEuroSCORE is an established tool to predict the risk of mortality during cardiac surgery. In high-risk patients percutaneous mitral valve repair with the MitraClip system represents a less-invasive alternative METHODS: Data from 1002 patients, who underwent percutaneous mitral valve repair with the MitraClip system, were analyzed in the German Transcatheter Mitral Valve Interventions (TRAMI) Registry. A logEuroSCORE (mortality risk in %) ≥ 20 was considered high risk RESULTS: Of all patients, 557 (55.6%) had a logEuroSCORE ≥ 20. Implantation of the MitraClip was successful in 95.5 % (942/986) patients. Moderate residual mitral valve regurgitation was more often detected in patients with a logEuroSCORE ≥ 20 (23.8% vs. 17.1%, respectively, P < 0.05). In patients with a logEuroSCORE ≥ 20 the procedural complication rate was 8.9% (vs. 6.4, n.s.) and the in-hospital MACCE rate 4.9% (vs. 1.4% P < 0.01). The in-hospital mortality rate in patients with a logEuroSCORE ≥ 20 and logEuroSCORE < 20 was 4.3 and 1.1%, respectively (P ≤ 0.01) CONCLUSION: Percutaneous mitral valve repair with the MitraClip system is feasible in patients with a logEuroSCORE ≥ 20 with similar procedural results compared to patients with lower predicted risk. Although mortality was four times higher than in patients with logEuroSCORE < 20, mortality in high risk patients was lower than predicted. In those with a logEuroSCORE ≥ 20, moderate residual mitral valve regurgitation was more frequent.

Cerebral embolization during transcatheter aortic valve implantation: a transcranial Doppler study.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is associated with a higher risk of neurological events for both the transfemoral and transapical approach than surgical valve replacement. Cerebral magnetic resonance imaging has revealed more new, albeit clinically silent lesions from procedural embolization, yet the main source and predominant procedural step of emboli remain unclear. METHODS AND RESULTS: Eighty-three patients underwent transfemoral (Medtronic CoreValve [MCV(TF)], n=32; Edwards Sapien [ES(TF)], n=26) and transapical (ES(TA): n=25) TAVI. Serial transcranial Doppler examinations before, during, and 3 months after TAVI were used to identify high-intensity transient signals (HITS) as a surrogate for microembolization. Procedural HITS were detected in all patients, predominantly during manipulation of the calcified aortic valve while stent valves were being positioned and implanted. The balloon-expandable ES prosthesis caused significantly more HITS (mean [95% CI]) during positioning (ES(TF), 259.9 [184.8-334.9]; ES(TA), 206.1[162.5-249.7]; MCV(TF), 78.5 [25.3-131.6]; P<0.001) and the self-expandable MCV prosthesis during implantation (MCV(TF), 397.1 [302.1-492.2]; ES(TF), 88.2 [70.2-106.3]; ES(TA), 110.7 [82.0-139.3]; P<0.001). Overall, there were no significant differences between transfemoral and transapical TAVI or between the MCV and ES prostheses. No HITS were detected at baseline or 3-month follow-up. There was 1 major procedural stroke that resulted in death and 1 minor procedural stroke with full recovery at 3-month follow-up in the MCV group. CONCLUSIONS: Procedural HITS were detected by transcranial Doppler in all patients. Although no difference was observed between the transfemoral and the transapical approach with the balloon-expandable ES stent valve, transfemoral TAVI with the self-expandable MCV prosthesis resulted in the greatest number of HITS, predominantly during implantation.

Hemodynamic assessment of paravalvular aortic regurgitation after TAVI: estimated myocardial supply-demand ratio and cardiovascular mortality.

A relevant (at least moderate) paravalvular regurgitation (PAR) after transcatheter aortic valve implantation (TAVI) is found in up to 20% of cases and associated with increased mortality. The ratio of the diastolic over the systolic pressure time integral (DPTI:SPTI) has been proposed to reflect an estimate of myocardial oxygen supply versus demand and the propensity for myocardial ischemia. We have now evaluated the potential of this ratio to predict PAR-associated cardiovascular mortality after TAVI, retrospectively analyzing data from 167 consecutive TAVI patients. PAR was graded angiographically, and the myocardial supply-demand ratio was estimated from the planimetric integration of the diastolic and systolic pressure-time area (DPTI and SPTI), respectively. PAR was observed in 113 patients (67%) and angiographically graded as mild in 89 (78.8%), moderate in 21 (18.6%) or moderate to severe in 3 (2.7%) cases. The DPTI:SPTI ratio decreased with increasing Sellers grade of PAR (P < 0.001). A DPTI:SPTI of ≤0.7 predicted cardiovascular mortality (area under the curve = 0.96). Cardiovascular mortality at 30 days and 1 yr was increased in patients with DPTI:SPTI ≤ 0.7 over those with DPTI:SPTI > 0.7 (42 vs. 2% and 63 vs. 3%, respectively; P < 0.001). In conclusion, DPTI:SPTI provides an excellent cutoff value of ≤0.7 for the prediction of PAR-associated mortality.

Suture-mediated arterial access site closure after transfemoral aortic valve implantation.

OBJECTIVES: To evaluate feasibility, safety and efficacy of percutaneous arterial access site closure after transfemoral, transcatheter aortic valve implantation (TF-TAVI) using a single, commercially available six French monofilament suture-mediated vascular closure device (VCD) in "preclosure" technique. BACKGROUND: Currently, TF-TAVI is evolving into a completely percutaneous procedure. However, percutaneous access site closure still remains a major technical challenge with room for improvement. METHODS: 94 of 144 consecutive patients underwent completely percutaneous TF-TAVI using following technique for access site closure: After puncture of the common femoral artery using fluoroscopy and contralateral angiography for guidance, the VCD was deployed prior further predilatation of the vessel and insertion of the large-bore introducer sheath. At the end of the procedure, the preloaded sutures were tied for final hemostasis and crossover angiography was used for postprocedural evaluation of the access vessel. RESULTS: Application of the VCD was technically successful in all cases, resulting in an efficient hemostasis with cessation of any bleeding within 10 min of final knot-tying in 83 of the 94 patients, and there was only one closure-failure with continuous bleeding despite prolonged manual compression requiring endovascular treatment. In addition, we observed four closure-related access vessel stenoses of hemodynamic relevance requiring endovascular treatment in three and surgical repair in one patient. However, interventional and surgical repair was not associated with death or irreversible end-organ damage and all patients recovered without sequelae. CONCLUSION: "Preclosure" of the arterial access site with a single six French suture-mediated VCD is relatively easy, safe and efficient method for access site closure after TF-TAVI which, along with ongoing profile reductions of TAVI devices, should further simplify and broaden the way toward a routine, completely percutaneous procedure.

Impact of aortic valve calcification on the outcome of transcatheter aortic valve implantation: results from the prospective multicenter German TAVI registry.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) is an emerging technology in patients with severe aortic stenosis. BACKGROUND: Whether the degree of aortic valve calcification impacts the outcome after TAVI has not been thoroughly evaluated. METHODS: We analyzed data from the prospective multicenter German TAVI registry, including 1,365 patients as of July 2010. Patients were divided into three groups, based on the degree of aortic valve calcification: mild (n = 67), moderate (n = 392), and severe (n = 906) valve calcification, determined by visual estimation by the operator. RESULTS: Mean age was 81.7 ± 6.2 years; mean logistic EUROscore was 20.6 ± 13.7%. Patients with severe aortic valve calcification had a higher mean and peak-to-peak gradient before the intervention (P < 0.0001). Technical success was achieved in 97%, similar in each group. The Medtronic CoreValve was implanted in 80.8%, the Sapien Edwards prosthesis in the remaining cases. The duration of the procedure and fluoroscopy was higher in the group with severe calcification (P < 0.01 for procedure and P < 0.05 for fluoroscopy). During the periprocedural period there were no differences among the groups regarding in-hospital death, cerebrovascular events, myocardial infarction, thromboembolic events, aortic dissection, or severe vascular complications. Furthermore, there was no significant difference in postprocedural aortic mean gradient (7.0 mm Hg vs. 5.6 mm Hg vs. 6.3 mm Hg; P = 0.07), in residual aortic regurgitation (74% vs. 72% vs. 68%; P = 0.3) or postprocedure pacemaker implantation (38% vs. 30.4% vs. 34.2%; P = 0.35). During 30-day follow up there was no difference in regard to the number of death, strokes, and myocardial infarctions. CONCLUSIONS: Our results of a real-world registry suggest that the extent of aortic valve calcification does not influence the success or procedural outcome significantly.