Assessment of coronary artery disease during hospitalization for cancer treatment.

BACKGROUND: With improvement of cancer-specific survival, comorbidities and treatment-related side effects, particularly cardiovascular toxicities, need close attention. The aim of the present study was to evaluate clinical characteristics and outcomes of cancer patients requiring coronary angiography during inpatient care. METHODS: We performed a retrospective analysis of patients hospitalized between 02/2011 and 02/2018 in our two university hospital cancer centers. From a cohort of 60,676 cancer patients, we identified 153 patients (65.7 ± 11.6 years, 73.2% male), who underwent coronary angiography and were eligible for analysis. These were compared to a control group of 153 non-cancer patients pair-matched with respect to age, sex, and indication for catheterization. RESULTS: Cancer patients presented in 66% with an acute coronary syndrome (ACS). The most prevalent cancer entities were lymphoma (19%) and lung cancer (18.3%). The rate of primary percutaneous coronary interventions (PCI) was significantly lower in the cancer cohort (40.5% vs. 53.6%, p = 0.029), although manifestation of coronary artery disease (CAD) and PCI results were comparable (SYNergy between PCI with TAXus and cardiac surgery (SYNTAX)-score, delta pre- and post-PCI - 9.8 vs. - 8.0, p = 0.2). Mortality was remarkably high in cancer patients (1-year mortality 46% vs. 8% in non-cancer patients, p < 0.001), particularly with troponin-positive ACS (5-year mortality 71%). CONCLUSION: Strategies to effectively control cardiovascular risks in cancer patients are needed. Additionally, suspected CAD in cancer patients should not prevent prompt diagnostic clarification and optimal revascularization as PCI results in cancer patients are comparable to non-cancer patients and occurrence of troponin-positive ACS leads to a significantly increased risk of mortality.

Troponins and Natriuretic Peptides in Cardio-Oncology Patients-Data From the ECoR Registry.

BACKGROUND: The long-term survival of cancer patients has significantly improved over the past years. Despite their therapeutic efficacy, various cancer therapies are associated with cardiotoxicity. Therefore, timely detection of cardiotoxic adverse events is crucial. However, the clinical assessment of myocardial damage caused by cancer therapy remains difficult. METHODS: This retrospective study was performed to evaluate the diagnostic value of cardiac troponin I (cTnI) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) for monitoring cancer therapy-induced cardiomyopathy. A total of 485 cancer patients referred to our cardio-oncology unit between July 2018 and January 2020 were selected from our Essen Cardio-oncology Registry (ECoR). We included patients with all types of cancer. Plasma concentrations of cTnI and NT-proBNP were measured by radioimmunoassay, and two-dimensional left ventricular ejection fraction (2D-LVEF), diastolic function, and global longitudinal strain (GLS) were measured by transthoracic echocardiography. In 116 patients, assessment was conducted before the induction of cancer therapy and during a short-term follow-up period; n = 42 of these were treated for malignant melanoma, and n = 42 with serial measurements were under treatment for breast cancer. RESULTS: In cross-sectional data, elevated NT-proBNP was associated with reduced LVEF and pathological GLS in the total cohort. A total of 116 patients had serial LVEF and biomarker measurements, and changes in NT-proBNP and troponin correlated with changes in LVEF during follow-up investigations. Similar to the total cohort, a subgroup of patients treated for malignant melanoma showed a correlation between the change in cTnI and the change in LVEF. In a subgroup analysis of patients undergoing breast cancer therapy, a correlation between the change in NT-proBNP and the change in LVEF could be detected. Thirty patients presented with chemotherapy-induced cardiomyopathy, defined as a significant LVEF decrease (> 10%) to a value below 50%. The number of patients with increased cTnI and NT-proBNP was significantly higher in patients with chemotherapy-induced cardiomyopathy than in patients without cardiotoxicity. Patients with positive cTnI and NT-proBNP were more likely to have a history of coronary heart disease, atrial fibrillation, and arterial hypertension. CONCLUSION: Our data suggest that cardiac biomarkers play an important role in the detection of cancer therapy-induced cardiotoxicity. Larger systematic assessment in prospective cohorts is mandatory.

Impact of left-ventricular end-diastolic pressure as a predictor of periprocedural hemodynamic deterioration in patients undergoing Impella supported high-risk percutaneous coronary interventions.

BACKGROUND: An increasing number of high-risk percutaneous coronary interventions (PCI) are performed with mechanical circulatory support (MCS) to minimize the risk of periprocedural hemodynamic compromise. Prior studies have demonstrated that an elevated left-ventricular end-diastolic pressure (LVEDP) is associated with worse outcome after acute myocardial infarction or cardiac surgery. Although LVEDP is frequently measured, little is known about the usefulness for predicting periprocedural hemodynamic deterioration in high-risk PCI. The objective of this study is to assess the impact of preprocedural measured LVEDP in non-shock patients undergoing high-risk PCI with MCS on periprocedural hemodynamic deterioration. METHODS AND RESULTS: We reviewed the PCI protocol and the Automated Impella Controller in a consecutive series of 64 patients (mean age 73 years, 80% male), who underwent high-risk PCI with Impella MCS (period 01/2017-12/2018). LVEDP (17 ± 8 mm Hg) was measured in all cases before Impella insertion and start of PCI. Periprocedural hemodynamic deterioration was defined as: systolic blood pressure (SBP) drop (decrease ≥20 mm Hg or ≤90 mm Hg), or transient loss of arterial pressure pulsatility. Hemodynamic deterioration occurred in 33% (n = 21) of all patients but did not lead to a hemodynamic compromise due to the Impella support. Regression analysis of LVEDP for periprocedural hemodynamic deterioration or in-hospital major adverse cardiac and cerebrovascular events (MACCE) showed no significant results. CONCLUSION: LVEDP was not associated with periprocedural hemodynamic deterioration or a higher rate of in-hospital MACCE. Our data propose that LVEDP may not be used as a risk stratification variable for MCS usage in non-shock patients undergoing high-risk PCI.

Troponins and brain natriuretic peptides for the prediction of cardiotoxicity in cancer patients: a meta-analysis.

AIMS: Cardiac biomarkers are a mainstay in diagnosis of cardiovascular disease but their role in cardio-oncology has not yet been systematically evaluated. This meta-analysis aims to determine whether cardiac troponins and (N-terminal pro) brain natriuretic peptide (BNP/NT-proBNP) predict cancer therapy-related left ventricular (LV) dysfunction. METHODS AND RESULTS: Scientific databases were searched for studies that assessed troponins or BNP/NT-proBNP in adult patients undergoing cancer therapy. Data from 61 trials with 5691 patients were included. Cancer therapy was associated with an increase in troponin levels [odds ratio (OR) 14.3, 95% confidence interval (CI) 6.0-34.1; n = 3049]. Patients with elevated troponins receiving chemotherapy or human epidermal growth factor receptor 2 inhibitor therapy were at higher risk for LV dysfunction (OR 11.9, 95% CI 4.4-32.1; n = 2163). Troponin had a negative predictive value of 93%. Mean BNP/NT-proBNP levels were increased in patients post-treatment (standardized mean difference 0.6, 95% CI 0.3-0.9; n = 912), but the available evidence did not consistently indicate prediction of LV dysfunction (OR 1.7, 95% CI 0.7-4.2; n = 197). ß-blocker and angiotensin-converting enzyme inhibitor therapy to mitigate cardiotoxicity during cancer therapy was associated with a decline in serum troponins (OR 4.1, 95% CI 1.7-9.8; n = 466). CONCLUSION: Elevated troponin levels predict LV dysfunction in patients receiving cancer therapy. Assessment of troponin levels may qualify as a screening test to identify patients who require referral to cardio-oncology units and benefit from preventive strategies. Further evidence is required for both biomarkers.

Six months follow-up of protected high-risk percutaneous coronary intervention with the microaxial Impella pump: results from the German Impella registry.

BACKGROUND: Percutaneous coronary intervention (PCI) represents an important alternative to coronary bypass surgery for the treatment of patients with complex coronary artery disease and high perioperative risk. Protected percutaneous coronary intervention applies temporary percutaneous ventricular assist devices to mitigate potential hemodynamic compromise in high-risk patients. The Impella system is currently the most commonly used device for protected percutaneous coronary intervention and showed improved hemodynamic parameters in earlier trials. METHODS: This study was designed as a retrospective, observational multi-center registry conducted in ten hospitals in Germany. We included consecutive patients undergoing protected high-risk percutaneous coronary intervention with Impella support. The primary endpoint was defined as the occurrence of a major adverse cardiac event defined as all-cause mortality, ST-elevation myocardial infarction, or stroke during a postprocedural 180-day follow-up period. RESULTS: In total, 157 patients (80.3% male; mean age 71.8 ± 10.8 years) were included in the present study, and 180-day follow-up was complete for 149 patients (94.9%). At baseline, the patients had a median left ventricular ejection fraction of 39.0% (interquartile range, 25.0-50.0%). The median SYNergy between PCI with TAXUS and Cardiac Surgery-Score I was 33.0 (interquartile range, 24.0-40.5) and the median EuroSCORE II was 7.2% (interquartile range, 3.2-17.1%). During postprocedural follow-up, 34 patients (22.8%) suffered a major adverse cardiac event. All-cause mortality was 18.1% (27 patients). Nine patients (6.0%) sustained a ST-elevation myocardial infarction, while 4 patients (2.7%) had a stroke. CONCLUSIONS: Patients undergoing protected high-risk percutaneous coronary intervention with Impella support showed an acceptable 180-day clinical outcome regarding major adverse cardiac event and mortality.

Access site complications following Impella-supported high-risk percutaneous coronary interventions.

Mechanical circulatory support (MCS) devices are increasingly used to provide hemodynamic stability for patients with severe coronary artery disease, comorbidities, and/or impaired hemodynamics during high-risk percutaneous coronary interventions (PCI). Vascular access site complications, particularly those due to the use of large-bore sheaths, may limit outcomes in these patients. The aim of this study was to investigate the incidence and predictors of vascular complications in protected high-risk PCIs. Therefore, we included patients undergoing high-risk PCI with an Impella device from January 2016 to August 2018. Vascular complications were graded according to 'Valve Academic Research Consortium-2', a definition routinely used in transcatheter valve implantation procedures. In total, 61 patients (mean age 72 ± 11 years, 79% male, SYNTAX score 33 ± 7) were included, and angiographic- and fluoroscopic-guided vascular access was used for Impella implantation in all patients. Major vascular complications occurred in 5 male patients (8%). All major vascular complications were treated conservatively without the need for surgical intervention, and only one patient received a transfusion of three erythrocyte concentrates. Regression analysis revealed that patients with peripheral arterial disease of the lower extremities are at higher risk of major vascular complications. In conclusion, the utilization of Impella using a standardized protocol for angiographic- and fluoroscopic-guided vascular access was associated with a low rate of vascular complications.

Impact of Liver Indicators on Clinical Outcome in Patients Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: Liver dysfunction increases death and morbidity after cardiac operations. There are currently no data evaluating liver function in patients undergoing transcatheter aortic valve replacement (TAVR). We aimed therefore to evaluate our TAVR results in regard to liver function. METHODS: A total of 640 consecutive TAVR patients were evaluated. Of those, 11 patients presented with chronic liver disease before TAVR. The Model for End-Stage Liver Disease score was used to measure liver function in these patients. The primary study end point was 30-day mortality in patients presenting with liver dysfunction. Secondary study end point was liver enzymes after TAVR. RESULTS: The mean Model for End-Stage Liver Disease score in patients with chronic liver disease was 16.8 ± 6.2 (median, 18; range, 7 to 26). The 30-day mortality was 9.1% (57 of 629) in patients presenting without liver disease and 9.1% (1 of 11) in patients with liver disease (p = 1.00). Patients with chronic liver disease showed significantly higher preoperative levels of γ-glutamyl transpeptidase (p < 0.001). After TAVR, we observed a significant increase in alanine aminotransferase on postoperative day 3 compared with preoperative values (p < 0.001), accompanied by a decrease in albumin (p < 0.001). CONCLUSIONS: Liver cirrhosis per se is not considered as a contraindication for cardiac operations. In the present study, we did not observe a higher 30-day mortality rate in liver cirrhotic patients undergoing TAVR, suggesting TAVR as a feasible alternative with acceptable outcomes in patients with chronic liver disease. Moreover, the present study is the first to evaluate liver variables in patients undergoing TAVR.

No protection of heart, kidneys and brain by remote ischemic preconditioning before transfemoral transcatheter aortic valve implantation: Interim-analysis of a randomized single-blinded, placebo-controlled, single-center trial.

BACKGROUND: Remote ischemic preconditioning (RIPC) reduces myocardial injury and improves clinical outcome in patients undergoing coronary revascularization, but only in the absence of propofol-anesthesia. We investigated whether RIPC provides protection of heart, kidneys and brain and improves outcome in patients undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI). METHODS: Patients undergoing TF-TAVI were randomized to receive RIPC (3cycles of 5min left upper arm ischemia and 5min reperfusion) or placebo. The primary endpoint was myocardial injury, reflected by the area under the curve for serum troponin I concentrations (AUC-TnI) over the first 72h. Secondary endpoints included the incidences of periprocedural myocardial infarction, delayed gadolinium enhancement on postprocedural cardiac MRI, acute kidney injury, periprocedural stroke, and the incidence and volume of new lesions on postprocedural cerebral MRI. All-cause and cardiovascular mortality and major adverse cardiac and cerebrovascular events (MACCE) were assessed over 1-year follow-up. A prespecified interim-analysis was performed after the last patient had completed 1-year follow-up (NCT02080299). RESULTS: 100 consecutive patients were enrolled between September 2013 and June 2015. There were no significant between-group differences in the primary endpoint of peri-interventional myocardial injury (ratio RIPC/placebo AUC-TnI: 0.87, 95% CI: 0.57-1.34, p=0.53) or the secondary endpoints of cardiac, renal and cerebral impairment. There was no significant treatment effect in subgroup-analyses of patients undergoing cardiac or cerebral MRI. Mortality and MACCE did not differ. No RIPC-related adverse events were observed. CONCLUSIONS: RIPC did neither protect heart, kidneys and brain nor improve clinical outcome in patients undergoing TF-TAVI.

Intraaortic Protection From Embolization in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation.

PURPOSE: Transcatheter aortic valve implantation (TAVI) results in the dislodgement of debris with risk of cerebral lesions or stroke. The EMBOL-X protection device (Edwards Lifesciences, Irvine, CA) is positioned within the ascending aorta to capture such debris. DESCRIPTION: Between July 2012 and April 2014 we randomly assigned 30 high-risk patients to undergo transaortic TAVI with the SAPIEN XT prosthesis (Edwards Lifesciences) combined with either the EMBOL-X device (group-1, n = 14) or without (group-2, n = 16). Periprocedural cerebral lesions were assessed by diffusion-weighted magnetic resonance imaging (DW-MRI) at baseline and within 7 days post-procedurally. EVALUATION: New foci of restricted diffusion on cerebral DW-MRI were found in 69% in group-2 and 50% in group-1. Lesion size was smaller in patients treated with the EMBOL-X device than in those without (88 ± 60 vs 168 ± 217 mm(3), p = 0.27, t = 1.2, degrees of freedom = 10). Transaortic TAVI patients treated with the EMBOL-X device had significantly smaller lesion volumes in the supply region of the middle cerebral artery (33 ± 29 vs 76 ± 67 mm(3), p = 0.04). There were no neurologic events after transaortic TAVI. CONCLUSIONS: The intraaortic protection device seems to reduce both the incidence and the volume of new cerebral lesions (ClinicalTrials.gov number, NCT01735513).

Low Incidence of Paravalvular Leakage With the Balloon-Expandable Sapien 3 Transcatheter Heart Valve.

BACKGROUND: We evaluated the clinical and hemodynamic performance of the new balloon-expandable Sapien 3 (Edwards Lifesciences, Irvine, CA) transcatheter heart valve (S3 THV). METHODS: Between April 2013 and January 2015, 54 consecutive high-risk patients presenting with aortic stenosis were treated with the new S3 THV. Clinical and hemodynamic data as well as device and procedure variables were obtained at baseline, intraoperatively and at 30-days according to Valve Academic Research Consortium-2. RESULTS: The S3 THV was implanted in 41 patients (44% female) via transapical access and in 13 patients via transaortic access. Patients were a mean ± standard deviation age of 80.3 ± 6.0 years. The mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of all patients was 33.3% ± 13.4%, the mean The Society of Thoracic Surgeons Score was 6.7% ± 5.3%, and the mean EuroSCORE II was 7.0% ± 5.5%. All patients underwent successful implantation (23 mm, n = 12; 26 mm, n = 22; 29 mm, n = 20), without any intraprocedural complications or repeat ballooning. At 30 days, 53 patients (97.8%) showed no or mild paravalvular aortic regurgitation, 1 patient (2.2%) showed moderate regurgitation, and no patients had more than moderate postprocedural aortic regurgitation. Stroke incidence was 3.7% (2 of 54), and all-cause mortality was 3.7% (2 of 54, sepsis and multiorgan failure). Two patients required a new pacemaker. At 30 days, all patients were in New York Heart Association Functional Class I or II, and the mean pressure gradients were 10.8 ± 3.6 mm Hg. CONCLUSIONS: The present study shows excellent clinical and hemodynamic outcomes of high-risk transapical valve replacement patients treated with the new S3 THV. The S3 THV shows a low incidence of postoperative aortic regurgitation, with 98% presenting with less than mild aortic regurgitation.

Outcome in TAVI patients with symptomatic aortic stenosis not fulfilling PARTNER study inclusion criteria.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has rapidly evolved to the standard-of-care for inoperable patients with severe, symptomatic aortic valve stenosis, and to an alternative treatment option for high-risk patients. However, the randomized PARTNER trial excluded patients with conditions frequently encountered in daily clinical practice. METHODS: From 2006 to 2011, 467 high-risk patients, who underwent transfemoral TAVI (Edwards Sapien n = 166; Medtronic CoreValve n = 301) at two German centers were divided into a "PARTNER-like" (n = 227) and a "Real-World" cohort (n = 240), based on the original PARTNER trial in- and exclusion criteria. Differences in 30-day and 2-year mortality and morbidity were assessed. RESULTS: Mean age of patients was 80 ± 8 years with a logistic EuroSCORE of 22 ± 16%. The most frequent exclusion criteria were previous PCI (15.4%), prior valve surgery (13.7%), chronic renal failure (12.0%), and severe mitral regurgitation (10.8%). Despite significant differences in baseline data, estimated perioperative mortality in terms of STS and logistic EuroScore was identical between both groups. However, patients in the "Real-World" cohort had a non-significant trend towards a higher 30-day mortality (10.0% vs. 6.7%, P = 0.088) and a significantly higher 2-year mortality (23.3% vs. 14.5%, P = 0.016) compared with patients of the "PARTNER-like" cohort. CONCLUSION: Patients meeting PARTNER study exclusion criteria had an acceptable outcome at 30 days and 2 years, however, with significant differences to "PARTNER-like" patients. Still, our results indicate that also real-life patients with relevant comorbidities, who would have been excluded from the randomized PARTNER trials, benefit from TAVI with acceptable short- and long-term outcome.

Conventional aortic valve replacement or transcatheter aortic valve implantation in patients with previous cardiac surgery.

BACKGROUND: Clinical outcomes were compared among patients with previous cardiac surgery undergoing transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (AVR). METHODS: Between 2007 and 2014 a total of 142 consecutive patients with previous cardiac surgery were treated by TAVI either by the transfemoral (n=68) or transapical access (n=74), and 236 patients underwent a surgical redo-AVR. Of these patients, propensity analysis (m:n) matched 62 (group 1, TAVI) and 51 patients (group 2, redo-AVR). A multivariate logistic regression model was constructed. Moreover, mortality was compared between both groups by Cox regression. RESULTS: Both groups differed significantly (p<0.01) in regard to age and preoperative risk scores (EuroSCORE and STS-Score). Thirty-day mortality was 14.5% (9/62) in group 1 and 5.8% (3/51) in group 2 (p=0.23). Risk-adjusted multivariable analysis revealed only the logistic EuroSCORE to be strongly correlated with 30-day mortality (p=0.01). Multivariate analysis showed no difference in 30-day mortality between both groups (p=0.21). Multivariate Cox regression revealed New York Heart Association functional class (p=0.001), logistic EuroSCORE (p=0.01), and STS-Score (p=0.03) to be strongly associated with overall mortality. Moreover, evaluating overall mortality, Cox regression showed no difference between both groups (p=0.36). CONCLUSIONS: The present study shows that in patients with cardiac reoperation, TAVI comes with similar outcomes when compared to surgical AVR. On the other hand, conventional redo-AVR is still a valuable and safe treatment option.

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.

Comparison between different risk scoring algorithms on isolated conventional or transcatheter aortic valve replacement.

BACKGROUND: There are a number of scoring systems for risk evaluation in cardiac surgery, the most important of which are the European System for Cardiac Operative Risk Evaluation (EuroSCORE), The Society of Thoracic Surgeons (STS) score, the ACEF score (acronym for age, preoperative creatinine, and ejection fraction), and more recently, the new EuroSCORE-II. The aim of our study was to analyze and compare the predictive value of these scores in patients undergoing aortic valve replacement (AVR) or transcatheter aortic valve replacement (TAVR). METHODS: A total of 1,512 consecutive patients undergoing either conventional AVR (n = 1,066) or TAVR (transfemoral, n = 291; transapical, n = 155) were enrolled. Logistic and additive EuroSCORE of all patients were 13.3% ± 13.2% and 7.8% ± 3.3%, on average. The mean STS score, ACEF score, and EuroSCORE-II were 5.7% ± 5.0%, 1.5% ± 0.7%, and 4.2% ± 4.9%, respectively. RESULTS: Overall mortality at 30 days was 6.3%. The area under the curve (AUC) was 73.8 for the logistic EuroSCORE and 73.5 for the additive EuroSCORE. The STS score gave an AUC of 70.8. The AUCs for the ACEF and EuroSCORE-II were 63.8 and 71.2, respectively. In the transfemoral TAVR group, AUCs were 59.8 and 59.3 for the logistic and additive EuroSCORE, respectively, 63.2 for the STS score, and 55.9 and 55.4 for the ACEF and EuroSCORE-II, respectively. In the transapical TAVR group, AUCs were 88.0 and 82.8 for the logistic and additive EuroSCORE, respectively, 79.0 for the STS score, and 61.7 and 83.7 for the ACEF and EuroSCORE-II, respectively. CONCLUSIONS: Overall, 30-day mortality was best predicted by the STS score. Discrimination threshold predicting mortality was equal between all other risk calculators. Surprisingly, the new EuroSCORE-II was not superior to other models in risk prediction for AVR and TAVR patients.

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.

Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study.

BACKGROUND: The risk of stroke after transfemoral aortic valve implantation (TAVI) due to dislodgement and subsequent embolization of debris from aortic arch atheroma or from the calcified valve itself ranges between 2% and 10%. The rate of clinically silent cerebral ischemia is unknown but may be even higher. METHODS AND RESULTS: Thirty-two patients who underwent TAVI with the use of a balloon-expandable (n=22) or self-expandable (n=10) stent valve prosthesis were included in this descriptive study and compared with a historical control group of 21 patients undergoing open surgical aortic valve replacement. Periprocedural apparent and silent cerebral ischemia was assessed by neurological testing and serial cerebral diffusion-weighted magnetic resonance imaging at baseline, at 3.4 (2.5 to 4.4) days after the procedure, and at 3 months. TAVI was successful in all patients. After the procedure, new foci of restricted diffusion on cerebral diffusion-weighted magnetic resonance imaging were found in 27 of 32 TAVI patients (84%) and were more frequent than after open surgery (10 of 21 patients [48%]; P=0.011). These lesions were usually multiple (1 to 19 per patient) and dispersed in both hemispheres in a pattern suggesting cerebral embolization. Volumes of these lesions were significantly smaller after TAVI than after surgery (77 [59 to 94] versus 224 [111 to 338] mm(3); P<0.001). There were neither measurable impairments of neurocognitive function nor apparent neurological events during the in-hospital period among TAVI patients, but there was 1 stroke (5%) in the surgical patient group. On 3-month follow-up diffusion-weighted magnetic resonance imaging, there were no new foci of restricted diffusion, and there was no residual signal change associated with the majority (80%) of the foci detected in the periprocedural period. CONCLUSIONS: Clinically silent new foci of restricted diffusion on cerebral magnetic resonance imaging were detected in almost all patients (84%) undergoing TAVI. Although typically multiple, these foci were not associated with apparent neurological events or measurable deterioration of neurocognitive function during 3-month follow-up. Further work needs to be directed to determine the clinical significance of these findings in a larger patient population.