Publications by authors named "Theodor Fischlein"

167 Publications

About usefulness of GERAADA score.

Eur J Cardiothorac Surg 2021 Apr 11. Epub 2021 Apr 11.

Department of Cardiac surgery, Klinikum Nürnberg-Paracelsus Medical University, Nuremberg, Germany.

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http://dx.doi.org/10.1093/ejcts/ezab168DOI Listing
April 2021

Comparison between Surgical Access and Percutaneous Closure Device in 787 Patients Undergoing Transcatheter Aortic Valve Replacement.

J Clin Med 2021 Mar 24;10(7). Epub 2021 Mar 24.

Paracelsus Medical University, 90419 Nuremberg, Germany.

Background: The vascular access in transcatheter aortic valve replacement (TAVR) was initially dominated by a surgical approach. Meanwhile, percutaneous closure systems became a well-established alternative. The aim of this study was to compare the clinical outcome between the two approaches.

Methods: In this retrospective study, we observed 787 patients undergoing a TAVR-Procedure between 2013 and 2019. Of those, 338 patients were treated with surgical access and 449 with the Perclose ProGlide™-System (Abbott, Chicago, IL, USA). According to the Bleeding Academic Research Consortium (BARC) and Valve Academic Research Consortium (VARC) criteria, the primary combined endpoints were defined.

Results: Overall hospital mortality was 2.8% with no significant difference between surgical (3.8%) and percutaneous (2.2%) access ( = 0.182). Major vascular complications or bleeding defined as the primary combined endpoint was not significantly different in either group (Surgical group 5.3%, ProGlide group 5.1%, = 0.899). In the ProGlide group, women with pre-existing peripheral artery disease (PAD) were significantly more often affected by a vascular complication ( = 0.001 for female sex and = 0.03 for PAD).

Conclusions: We were able to show that the use of both accesses is safe. However, the surgical access route should also be considered in case of peripheral artery disease.
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http://dx.doi.org/10.3390/jcm10071344DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8037566PMC
March 2021

Leaflet Dimensions as a Guide to Remodeling Annuloplasty During Aortic Valve Repair.

Innovations (Phila) 2021 Mar 18:1556984521997422. Epub 2021 Mar 18.

5631 Department of Cardiovascular and Thoracic Surgery, West Virginia University Heart and Vascular Institute, Morgantown, WV, USA.

Objective: In chronic aortic insufficiency (AI), the method and degree of annular downsizing required to achieve durable coaptation in aortic valve repair (AVr) remains poorly defined. This study evaluated the relationship between leaflet size and annular diameter to predict adequate annular sizing in remodeling AVr.

Methods: Under regulatory supervision, 74 patients with chronic tri-leaflet AI underwent AVr using ring annuloplasty and leaflet reconstruction. Fifty-four (73%) had ascending aortic ( = 25) and/or root ( = 29) aneurysms, and aortic grafts were sized 5 to 7 mm larger than the rings. Intraoperatively, leaflet free-edge length (FEL) was measured with special ball sizers positioned in the coronary sinus, and "normal" annular diameter was predicted from the validated formula: Required "normal" diameter = FEL/1.5. "Normal" annular diameters predicted from FEL were compared with pathologic diameters measured intraoperatively with Hegar dilators, and both were correlated with gender, age, and BSA.

Results: Average age was 62.1 ± 13.3 years (mean ± SD), 73% (54/74) were male, and 96% (71/74) had moderate-to-severe AI. All patients had annular dilatation, with a pathologic diameter 26.6 ± 2.3 mm before repair, and a predicted "normal" diameter of 21.7 ± 1.7 mm ( < 0.001). Both predicted and pathologic annular diameters were larger in men ( < 0.001), but no relationship existed with age. BSA correlated with both predicted and pathologic diameters, although variability was large.

Conclusions: Based on a simple validated method to predict "normal" annular diameter, all patients with chronic AI have some degree of annular dilatation. This finding implies that most AVr should include annuloplasty, with adequate and precise annular reduction based on leaflet size.
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http://dx.doi.org/10.1177/1556984521997422DOI Listing
March 2021

Sutureless aortic valves in elderly patients with aortic stenosis and intermediate-risk profile.

J Cardiovasc Med (Hagerstown) 2021 Apr;22(4):297-304

Division of Cardiac Surgery, University of Brescia Medical School, Brescia, Italy.

Aims: Sutureless valves became an alternative to standard bioprostheses, allowing surgeons to significantly reduce cross-clamping and extracorporeal circulation times, with a potential positive impact on major postoperative complications. The aim of this European multicentre study was to evaluate the safety and efficacy of sutureless valves in patients with an intermediate-risk profile undergoing aortic valve replacement (AVR).

Methods: We investigated early and mid-term outcomes of 518 elderly patients with aortic stenosis at intermediate-risk profile (mean STS Score 6.1 ± 2%) undergoing AVR with sutureless aortic valve. Primary endpoints were 30-day mortality and freedom from all-cause death at follow-up. The secondary endpoint was survival freedom from MACCEs [all-cause death, stroke/transitory ischemic attack (TIA), bleeding, myocardial infarction, aortic regurgitation Grade II, endocarditis, reintervention and pacemaker implant; VARC 1--2 criteria].

Results: Sutureless valve implantation was successfully performed in 508 patients, with a procedural success rate of 98.1% (508/518) as per VARC criteria. Concomitant myocardial revascularization [coronary artery bypass grafting (CABG)] was performed in 74 out of 518 patients (14.3%). In-hospital mortality was 1.9% (10/518). Postoperative complications included revision for bleeding (23/518; 4.4%), prolonged intubation more than 48h (4/518; 0.7%), acute renal failure (14/518; 2.7%), stroke/TIA (11/518; 2.1%), pacemaker implantation (26/518; 5.1%) and aortic regurgitation more than Grade II (7/518; 1.4%). At 48-month follow-up, Kaplan-Meier overall survival and freedom from MACCEs in patients receiving isolated AVR were 83.7% [95% confidence interval (95% CI): 81.1-86.3] and 78.4% (95% CI: 75.5-81.4), respectively, while in patients with concomitant CABG, Kaplan-Meier overall survival and freedom from MACCEs were 82.3% (95% CI: 73.3-91.3) and 79.1% (95% CI: 69.9-88.3), respectively.

Conclusion: The use of sutureless aortic valves in elderly patients with an intermediate-risk profile provided excellent early and mid-term outcomes, providing a reliable tool in patients undergoing surgical AVR in this specific subset of population. These preliminary data need to be investigated with a TAVI control-group in further studies.
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http://dx.doi.org/10.2459/JCM.0000000000001120DOI Listing
April 2021

Calcium load assessment for aortic valve interventions: a call for consensus.

Eur J Cardiothorac Surg 2021 Feb 18. Epub 2021 Feb 18.

Department of Cardiac Surgery, Cardiovascular Center, Klinikum Nürnberg - Paracelsus Medical University, Nuremberg, Germany.

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http://dx.doi.org/10.1093/ejcts/ezab083DOI Listing
February 2021

Midterm outcomes with a sutureless aortic bioprosthesis in a prospective multicenter cohort study.

J Thorac Cardiovasc Surg 2021 Jan 13. Epub 2021 Jan 13.

Cardio-thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.

Objective: The objective of this study was to report midterm clinical outcomes with a self-expandable sutureless aortic valve.

Methods: Between 2010 and 2013, 658 patients at 25 European institutions received the Perceval sutureless valve (LivaNova Plc, London, United Kingdom). Mean follow-up was 3.8 years; late cumulative follow-up was 2325.2 patient-years.

Results: The mean age of the population was 78.3 ± 5.6 years and 40.0% (n = 263) were 80 years of age or older; mean Society of Thoracic Surgeons-Predicted Risk of Mortality score was 7.2 ± 7.4. Concomitant procedures were performed in 31.5% (n = 207) of patients. Overall duration of cardiopulmonary bypass time was 64.8 ± 25.2 minutes and aortic cross-clamping time was 40.7 ± 18.1 minutes. Thirty-day all-cause mortality was 3.7% (23 patients), with an observed:expected ratio of 0.51. Overall survival was 91.6% at 1 year, 88.5% at 2 years, and 72.7% at 5 years. Peak and mean gradients remained stable during follow-up, and were 17.8 ± 11.3 mm Hg and 9.0 ± 6.3 mm Hg, respectively, at 5 years. Preoperatively, 33.4% of those who received the Perceval valve (n = 210) were in New York Heart Association functional class I or II versus 93.1% (n = 242) at 5 years.

Conclusions: This series, representing, to our knowledge, the longest follow-up with sutureless technology in a prospective, multicenter study, shows that aortic replacement using sutureless valves is associated with low mortality and morbidity and good hemodynamic performance.
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http://dx.doi.org/10.1016/j.jtcvs.2020.12.109DOI Listing
January 2021

Sutureless versus conventional bioprostheses for aortic valve replacement in severe symptomatic aortic valve stenosis.

J Thorac Cardiovasc Surg 2021 03 14;161(3):920-932. Epub 2020 Dec 14.

Cardio-Thoracic Surgery Department, Heart and Vascular Center, Maastricht University Medical Center (MUMC+), Cardiovascular Research Institute Maastricht (CARIM), Maastricht, The Netherlands.

Objective: Sutureless aortic valves are a novel option for aortic valve replacement. We sought to demonstrate noninferiority of sutureless versus standard bioprostheses in severe symptomatic aortic stenosis.

Methods: The Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement is a prospective, randomized, adaptive, open-label trial. Patients were randomized (March 2016 to September 2018) to aortic valve replacement with a sutureless or stented valve using conventional or minimally invasive approach. Primary outcome was freedom from major adverse cerebral and cardiovascular events (composite of all-cause death, myocardial infarction, stroke, or valve reintervention) at 1 year.

Results: At 47 centers (12 countries), 910 patients were randomized to sutureless (n = 453) or conventional stented (n = 457) valves; mean ages were 75.4 ± 5.6 and 75.0 ± 6.1 years, and 50.1% and 44.9% were female, respectively. Mean ± standard deviation Society of Thoracic Surgeons scores were 2.4 ± 1.7 and 2.1 ± 1.3, and a ministernotomy approach was used in 50.4% and 47.3%, respectively. Concomitant procedures were performed with similar rates in both groups. Noninferiority was demonstrated for major adverse cerebral and cardiovascular events at 1 year, whereas aortic valve hemodynamics improved equally in both groups. Use of sutureless valves significantly reduced surgical times (mean extracorporeal circulation times: 71.0 ± 34.1 minutes vs 87.8 ± 33.9 minutes; mean crossclamp times: 48.5 ± 24.7 vs 65.2 ± 23.6; both P < .0001), but resulted in a higher rate of pacemaker implantation (11.1% vs 3.6% at 1 year). Incidences of perivalvular and central leak were similar.

Conclusions: Sutureless valves were noninferior to stented valves with respect to major adverse cerebral and cardiovascular events at 1 year in patients undergoing aortic valve replacement (alone or with coronary artery bypass grafting). This suggests that sutureless valves should be considered as part of a comprehensive valve program.
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http://dx.doi.org/10.1016/j.jtcvs.2020.11.162DOI Listing
March 2021

Redo aortic valve replacement for prosthesis endocarditis in patients previously classified as high or prohibitive risk: a narrative review.

Ann Transl Med 2020 Dec;8(23):1629

Department of Cardiac Surgery, Medical Microbiology and Infectiology, Klinikum Nürnberg - Paracelsus Medical University, Nuremberg, Germany.

Transcatheter aortic valve implantation (TAVI) and sutureless aortic valve replacement (Su-AVR) enabled in the last years many patients at high or prohibitive risk to be treated for their severe symptomatic aortic valve stenosis. As often happens in medicine, new techniques bring not only new hopes, but also new problems. In recent years, alongside the lengthening of the life of these patients treated with TAVI or Su-AVR, cardiologists and cardiac surgeons have had to face the long-term complications associated with the implantation of these devices, such as the prosthetic infective endocarditis. The correct management of prosthesis valve endocarditis after TAVI or Su-AVR in high risk patients, and the possible role of surgery are a matter of debate because pushing the limits of the modern medicine and becoming a new challenge for cardiac surgeons of 21 century. In this review, we summarized the incidence, characteristics and evidences for this new and controversial problem of the cardiovascular community. Moreover, we investigated the outcomes reported in literature of the conservative and the surgical strategy. Although the reported mortality rate of surgical treatment is high, seems not prohibitive, mostly if compared to conservative medical therapy. The collaborative exchange between cardiologist, cardiac surgeons, clinical microbiologists and expert of imaging is mandatory to face this challenge.
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http://dx.doi.org/10.21037/atm-20-4630DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7791219PMC
December 2020

Guidelines on prosthetic heart valve management in infective endocarditis: a narrative review comparing American Heart Association/American College of Cardiology and European Society of Cardiology guidelines.

Ann Transl Med 2020 Dec;8(23):1625

Cardiac Surgery, Centre Cardiologique du Nord de Saint-Denis, Paris, France.

Infective endocarditis (IE) represented over the last year a growing medical and surgical concern. The changes in etiology and demographic of the disease, which now includes also a large proportion of iatrogenic conditions, has prompted new studies and updates in the guideline for IE treatment. The increasing use of intravascular and intracardiac devices has introduced new challenges in terms of both antibiotic resistance and surgical treatment of prosthetic endocarditis. Also, patients with complex congenital heart diseases, intravenous drug abusers and patients with chronic renal failure under hemodialysis have been added to the list of high-risk subjects for IE. Important aspects concerning the establishment of the endocarditis team, the clinical management, the optimal medical therapy and the indication and timing for surgery are arguments of debate and controversy across the literature. In particular, the most adequate strategy to be adopted in the context of concomitant neurological complication remains greatly debated. Despite attempts to standardize the practice in IE, the lack of powered randomized clinical evidence prevented the achievement of a univocal consensus in several aspects of the management of IE. This situation reflects in some differences in the recommendation promoted by the European Society of Cardiology and American Heart Association/American College of Cardiology. In this review, we will compare the European Society of Cardiology and the American Heart Association guidelines and discuss important aspects related to clinical management and indications of for treatment.
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http://dx.doi.org/10.21037/atm-20-5134DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7791243PMC
December 2020

Sharing of decision-making for infective endocarditis surgery: a narrative review of clinical and ethical implications.

Ann Transl Med 2020 Dec;8(23):1624

Department of Cardiac Surgery, Centre Cardiologique du Nord de Saint-Denis, Paris, France.

Infective endocarditis (IE) is nowadays one of the most challenging disease in cardiac surgery because of its multifaceted clinical and anatomical presentation. Despite the many clinical and surgical advances achieved in the past 60 years, there is a lack of evidence regarding the ideal strategy. The present review aims to investigate and highlight two main novel concepts for the decision-making of the best substitute. Firstly, the concept of an "endocarditis team": a coordinated multidisciplinary effort in the diagnostic work-up, especially in conditions of high risk of embolization or clinical deterioration. A good "endocarditis team" has the role to overcome such problem, in order to ensure a prompt and balanced strategy. Secondly, which ethical considerations are required to drive the choice of valvular substitute. The choice of best valve substitute is a relevant issue of debate, not only with operative but also prognostic and accordingly ethical aftermaths. Many different solutions have been developed to substitute the infected valve. Among these: mechanical prosthesis (MP), biological stented prosthesis (BP), sutureless bioprosthesis and cryopreserved homografts (CHs). Patients need to be informed in detail about the technical issues pertaining the use of these valve substitute. We will discuss the evidences regarding the risk of recurrent infections or future potentially severe calcification of aortic homograft valve and wall (in other words, the failure of the homograft) and the difficulties in managing the reoperation.
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http://dx.doi.org/10.21037/atm-20-4626DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7791252PMC
December 2020

Surgical Treatment of Post-Infarction Left Ventricular Free-Wall Rupture: a Multicenter Study.

Ann Thorac Surg 2020 Dec 8. Epub 2020 Dec 8.

Department of Cardiothoracic Surgery, Heart and Vascular Centre, Maastricht University Medical Centre, Maastricht, The Netherlands.

Background: Left ventricular free-wall rupture (LVFWR) is an uncommon but serious mechanical complication of acute myocardial infarction (AMI). Surgical repair, though challenging, is the only definitive treatment. However, given the rarity of this condition, results following surgery are still not well established. The aim of this study was to review a multicenter experience with the surgical management of post-infarction LVFWR and analyze the associated early outcomes.

Methods: Using the CAUTION study database, we identified 140 patients who were surgically treated for post-AMI LVFWR in 15 different centers from 2001 to 2018. The main outcome measured was operative mortality. Multivariate analysis was carried out by constructing a logistic regression model to identify predictors of postoperative mortality.

Results: The mean age of patients was 69.4 years. The oozing type of LVFWR was observed in 79 patients (56.4%), and the blowout type in 61 subjects (43.6%). Sutured repair was used in the 61.4% of cases. The operative mortality rate was 36.4%. Low cardiac output syndrome was the main cause of perioperative death. Myocardial re-rupture after surgery occurred in 10 patients (7.1%). Multivariable analysis revealed that preoperative left ventricular ejection fraction (p < 0.001), cardiac arrest at presentation (p = 0.011), female gender (p = 0.044), and the need for preoperative extracorporeal life support (p = 0.003) were independent predictors for operative mortality.

Conclusions: Surgical repair of post-infarction LVFWR carries a high operative mortality. Female gender, preoperative left ventricular ejection fraction, cardiac arrest, and extracorporeal life support, are predictors of early mortality.
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http://dx.doi.org/10.1016/j.athoracsur.2020.11.019DOI Listing
December 2020

Predictors of pacemaker implantation after transcatheter aortic valve implantation according to kind of prosthesis and risk profile: a systematic review and contemporary meta-analysis.

Eur Heart J Qual Care Clin Outcomes 2021 Mar;7(2):143-153

Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza Hospital and University of Turin, Italy.

Aims: Permanent pacemaker implantation (PPI) may be required after transcatheter aortic valve implantation (TAVI). Evidence on PPI prediction has largely been gathered from high-risk patients receiving first-generation valve implants. We undertook a meta-analysis of the existing literature to examine the incidence and predictors of PPI after TAVI according to generation of valve, valve type, and surgical risk.

Methods And Results: We made a systematic literature search for studies with ≥100 patients reporting the incidence and adjusted predictors of PPI after TAVI. Subgroup analyses examined these features according to generation of valve, specific valve type, and surgical risk. We obtained data from 43 studies, encompassing 29 113 patients. Permanent pacemaker implantation rates ranged from 6.7% to 39.2% in individual studies with a pooled incidence of 19% (95% CI 16-21). Independent predictors for PPI were age [odds ratio (OR) 1.05, 95% confidence interval (CI) 1.01-1.09], left bundle branch block (LBBB) (OR 1.45, 95% CI 1.12-1.77), right bundle branch block (RBBB) (OR 4.15, 95% CI 3.23-4.88), implantation depth (OR 1.18, 95% CI 1.11-1.26), and self-expanding valve prosthesis (OR 2.99, 95% CI 1.39-4.59). Among subgroups analysed according to valve type, valve generation and surgical risk, independent predictors were RBBB, self-expanding valve type, first-degree atrioventricular block, and implantation depth.

Conclusions: The principle independent predictors for PPI following TAVI are age, RBBB, LBBB, self-expanding valve type, and valve implantation depth. These characteristics should be taken into account in pre-procedural assessment to reduce PPI rates. PROSPERO ID CRD42020164043.
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http://dx.doi.org/10.1093/ehjqcco/qcaa089DOI Listing
March 2021

Reply on Evaluation of Acquired Thrombocytopenia According to the Balloon-Expandable Versus Self-Expandable Valves in Patients Undergoing Transcatheter Aortic Valve Replacement.

Angiology 2021 03 1;72(3):295-296. Epub 2020 Dec 1.

Cardiac Surgery, 9211Klinikum Nürnberg-Paracelsus Medical University, Nuremberg, Germany.

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http://dx.doi.org/10.1177/0003319720974887DOI Listing
March 2021

Comment on Patient-tailored Therapy for Aortic Valve Stenosis: Open Questions and Future Directions.

Ann Surg 2020 Nov 12. Epub 2020 Nov 12.

Cardiac Surgery Department, Klinikum Nürnberg - Paracelsus Medical University, Nuremberg, Germany Cardiac Surgery Department, Klinikum Nürnberg - Paracelsus Medical University, Nuremberg, Germany.

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http://dx.doi.org/10.1097/SLA.0000000000004517DOI Listing
November 2020

Letter by Pollari et al Regarding Article, "Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: The PARTNER 3 Trial".

Circulation 2020 Nov 2;142(18):e308-e309. Epub 2020 Nov 2.

Cardiac Surgery, Klinikum Nürnberg - Paracelsus Medical University, Nuremberg, Germany.

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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.047864DOI Listing
November 2020

Minimally invasive sutureless and rapid deployment aortic valve replacement: the new benchmark for aortic valve surgery?

Ann Cardiothorac Surg 2020 Jul;9(4):328-329

Department of Cardiac Surgery, Klinikum Nürnberg - Paracelsus Medical University, Nuremberg, Germany.

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http://dx.doi.org/10.21037/acs-2019-surd-175DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7415695PMC
July 2020

Sutureless and rapid deployment implantation in bicuspid aortic valve: results from the sutureless and rapid-deployment aortic valve replacement international registry.

Ann Cardiothorac Surg 2020 Jul;9(4):298-304

Cardiac Surgery Unit, Lancisi Cardiovascular Center, Polytechnic University of Marche, Ospedali Riuniti, Ancona, Italy.

Background: Benefits of sutureless and rapid deployment (SURD) bioprostheses in bicuspid aortic valves (BAV) are controversial. The aim of this study is to report the outcomes of patients undergoing aortic valve replacement (AVR) for BAV from the Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry (SURD-IR).

Methods: Of the 4,636 patients who received primary isolated SURD-AVR between 2007 and 2018, 191 (4.1%) BAV patients underwent AVR with SURD valve.

Results: Overall 30-day mortality was 1.6%. The Intuity valve was implanted in 53.9% of cases, whereas the Perceval was implanted in 46.1%. Rate of stroke for isolated AVR was 4.2%. No case of endocarditis, thromboembolism, myocardial infarction, valve dislocation or structural valve deterioration was reported in the early phase. Rate of pacemaker implantation and moderate-severe aortic regurgitation (AR) were 7.9% and 3.7%, respectively.

Conclusions: BAV is not considered a contraindication for the implantation of SURD valves. However, detailed information of aortic root geometry as well as the knowledge of some technical considerations are mandatory for a good outcome.
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http://dx.doi.org/10.21037/acs-2020-surd-33DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7415698PMC
July 2020

Long-term outcomes of sutureless and rapid-deployment aortic valve replacement: a systematic review and meta-analysis.

Ann Cardiothorac Surg 2020 Jul;9(4):265-279

Cardiac Surgery, Paracelsus Medical University - Klinikum Nürnberg, Nuremberg, Germany.

Background: Sutureless and rapid-deployment aortic valve replacement (SURD-AVR) has become a prominent area of research as the medical community evaluate its place amongst other aortic valve interventions. The main advantages of SURD-AVR established to date are the reduced cross-clamp and cardiopulmonary bypass (CPB) times, as well as facilitating minimally invasive surgery in high-risk surgical patients. This current systematic review and meta-analysis, to our knowledge, is the first focusing on long-term outcomes regarding safety, efficacy and durability of SURD-AVR from available current literature.

Methods: A literature search via six electronic databases was performed from their inception to November 2019. Inclusion criteria for this systematic review included survival and postoperative echocardiographic outcomes greater than five years in patients who underwent SURD-AVR with either Perceval or Intuity valves. Studies were identified and data extracted by two independent reviewers. Long-term survival outcomes were aggregated using digitized Kaplan-Meier curves where available.

Results: After applying predefined inclusion and exclusion criteria, four studies were identified for review. All four studies were observational and in total reported data for 1,998 patients. Almost half (42.4%) of patients underwent SURD-AVR via full sternotomy, with almost one third (30.1%) also undergoing concomitant cardiac procedures. Aggregate overall survival rates at 1-, 2-, 3-, and 5-year follow-up were 94.9%, 91.2%, 89.0%, and 84.2%, respectively. Incidence of strokes (4.8%), severe paravalvular leaks (PVLs) (1.5%) and permanent pacemaker (PPM) insertion (8.2%) at up to 5-year follow-up were acceptable. At 5-year follow-up hemodynamic outcomes were also acceptable for mean pressure gradient (MPG) (range, 8.8-13.6 mmHg), peak pressure gradient (PPG) (range, 18.9-21.1 mmHg) and effective orifice area (EOA) (range, 1.5-1.8 cm).

Conclusions: Evaluation of the evidence reporting long-term outcomes of SURD-AVR suggests that it is a safe procedure for AVR with low rates of complications. Long-term outcomes presented in this review show that not only does SURD-AVR have acceptable survival rates, but also good hemodynamic performance at 5-year follow-up.
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http://dx.doi.org/10.21037/acs-2020-surd-25DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7415693PMC
July 2020

Sutureless versus transcatheter aortic valves in elderly patients with aortic stenosis at intermediate risk: A multi-institutional study.

J Thorac Cardiovasc Surg 2020 Jun 15. Epub 2020 Jun 15.

Universitätsklinik der Paracelsus Medizinischen Privatuniversität, Nuremberg, Germany.

Objective: This multi-institutional study compares the long-term outcome of elderly patients with severe aortic stenosis and an intermediate risk profile undergoing sutureless versus transcatheter aortic valve implantation.

Methods: From 2008 to 2015, 967 elderly patients (>75 years) with intermediate risk (Society of Thoracic Surgeons score 4%-8%) and isolated aortic stenosis were included in the study (sutureless valve = 481; transcatheter aortic valve implantation = 486). After propensity score matching, 2 matched groups of 291 patients were obtained. Transcatheter valves implanted in patients were the CoreValve (Medtronic, Minneapolis, Minn), Edwards SAPIEN-XT (Edwards Lifesciences, Irvine, Calif), and Acurate-TA (Symetis, Lausanne, Switzerland). Primary end points included all-cause death at 30 days and 5 years. Secondary end points included early and 5-year incidence of composite adverse events (major adverse cardiovascular events: all-cause death, stroke, pacemaker implant, myocardial infarction, paravalvular leak ≥II, and reoperation).

Results: After matching, there were no substantial differences between groups. The 30-day mortality was significantly lower in the sutureless valve group (sutureless valve = 1.7% vs transcatheter aortic valve implantation = 5.5%; P = .024) and the rate of permanent pacemaker implantation (sutureless valve = 5.5% vs transcatheter aortic valve implantation = 10.7%, P = .032). Stroke/transient ischemic attack cumulative incidence at 5 years was 1.4% in the sutureless valve group and 5.3% in the transcatheter aortic valve implantation group (P = .010). The incidence of perivalvular leak grade II or greater was 1.3% in the sutureless valve group and 9.8% in the transcatheter aortic valve implantation group (P < .001). At 60 months follow-up, the all-cause death rate was lower in the sutureless valve group than in the transcatheter aortic valve implantation group (sutureless valve = 16.1% ± 4.1% vs transcatheter aortic valve implantation = 28.9% ± 5.3%, P = .006), and the major adverse cardiovascular event rate was lower in the sutureless valve group (sutureless valve = 23.5% ± 4.1% vs transcatheter aortic valve implantation = 39.0% ± 5.6%, P = .002). Multivariable Cox regression identified transcatheter aortic valve implantation as an independent predictor for 5-year mortality and major adverse cardiovascular events (hazard ratio, 1.86; confidence interval, 1.09-3.18; P = .022) (hazard ratio, 1.73; confidence interval, 1.13-2.73; P = .010).

Conclusions: Sutureless valves improved the outcomes of aortic stenosis in elderly patients with an intermediate risk profile when compared with transcatheter aortic valve implantation. The use of transcatheter aortic valve implantation in this subset population should be evaluated in further controlled randomized trials with sutureless valve use in a comparative cohort.
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http://dx.doi.org/10.1016/j.jtcvs.2020.04.179DOI Listing
June 2020

Minimally invasive access type related to outcomes of sutureless and rapid deployment valves.

Eur J Cardiothorac Surg 2020 11;58(5):1063-1071

Cardiac Surgery Unit, Lancisi Cardiovascular Center, Polytechnic University of Marche, Ospedali Riuniti, Ancona, Italy.

Objectives: Minimally invasive surgical techniques with optimal outcomes are of paramount importance. Sutureless and rapid deployment aortic valves are increasingly implanted via minimally invasive approaches. We aimed to analyse the procedural outcomes of a full sternotomy (FS) compared with those of minimally invasive cardiac surgery (MICS) and further assess MICS, namely ministernotomy (MS) and anterior right thoracotomy (ART).

Methods: We selected all isolated aortic valve replacements in the Sutureless and Rapid Deployment Aortic Valve Replacement International Registry (SURD-IR, n = 2257) and performed propensity score matching to compare aortic valve replacement through FS or MICS (n = 508/group) as well as through MS and ART accesses (n = 569/group).

Results: Postoperative mortality was 1.6% in FS and MICS patients who had a mean logistic EuroSCORE of 11%. Cross-clamp and cardiopulmonary bypass (CPB) times were shorter in the FS group than in the MICS group (mean difference 3.2 and 9.2 min; P < 0.001). Patients undergoing FS had a higher rate of acute kidney injury (5.6% vs 2.8%; P = 0.012). Direct comparison of MS and ART revealed longer mean cross-clamp and CPB times (12 and 16.7 min) in the ART group (P < 0.001). The postoperative outcome revealed a higher stroke rate (3.2% vs 1.2%; P = 0.043) as well as a longer postoperative intensive care unit [2 (1-3) vs 1 (1-3) days; P = 0.009] and hospital stay [11 (8-16) vs 8 (7-12) days; P < 0.001] in the MS group than in the ART group.

Conclusions: According to this non-randomized international registry, FS resulted in a higher rate of acute kidney injury. The ART access showed a lower stroke rate than MS and a shorter hospital stay than all other accesses. All these findings may be related to underlying patient risk factors.
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http://dx.doi.org/10.1093/ejcts/ezaa154DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7577292PMC
November 2020

Higher rates of pacemaker implantation after rapid-deployment intuity aortic valve replacement: can it be improved?

Eur J Cardiothorac Surg 2021 Jan;59(1):287

Department of Cardiac Surgery, Paracelsus Medical University - Klinikum Nürnberg, Nuremberg, Germany.

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http://dx.doi.org/10.1093/ejcts/ezaa192DOI Listing
January 2021

Failure to achieve a satisfactory cardiac outcome after isolated coronary surgery in low-risk patients.

Interact Cardiovasc Thorac Surg 2020 07;31(1):9-15

Department of Surgery, Oulu University Hospital and Research Unit of Surgery, Anesthesiology and Critical Care, University of Oulu, Oulu, Finland.

Objectives: This study aims to investigate the incidence and determinants of major early adverse events in low-risk patients undergoing isolated coronary artery bypass grafting (CABG).

Methods: The multicentre E-CABG registry included 7352 consecutive patients who underwent isolated CABG from January 2015 to December 2016. Patients with an European System for Cardiac Operative Risk Evaluation (EuroSCORE) II of <2% and without any major comorbidity were the subjects of the present analysis.

Results: Out of 2397 low-risk patients, 11 (0.46%) died during the index hospitalization or within 30 days from surgery. Five deaths were cardiac related, 4 of which were secondary to technical failures. We estimated that 8 out of 11 deaths were potentially preventable. Logistic regression model identified porcelain aorta [odds ratio (OR) 34.3, 95% confidence interval (CI) 1.3-346.3] and E-CABG bleeding grades 2-3 (OR 30.2, 95% CI 8.3-112.9) as independent predictors of hospital death.

Conclusions: Mortality and major complications, although infrequently, do occur even in low-risk patients undergoing CABG. Identification of modifiable causes of postoperative adverse events may be useful to develop preventative strategies to improve the quality of care of patients undergoing cardiac surgery.

Clinical Trial Registration: NCT02319083 (https://clinicaltrials.gov/ct2/show/NCT02319083).
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http://dx.doi.org/10.1093/icvts/ivaa062DOI Listing
July 2020

Balloon Transcatheter Aortic Valve Replacement After Aortic Valve Repair With HAART 300 Device.

Ann Thorac Surg 2020 11 4;110(5):e375-e376. Epub 2020 May 4.

Department of Cardiac Surgery, Paracelsus Medical University Nuremberg, Nuremberg, Germany.

The HAART 300 (BioStable Science and Engineering, Austin, TX) is a rigid, elliptical device introduced to facilitate aortic valve repair providing annular stabilization in the setting of aortic regurgitation. Percutaneous strategies have been described for patients with dysfunctional biological prostheses or recurrence insufficiency after mitral ring annuloplasty. This report shows the feasibility of aortic valve-in-ring transcatheter aortic valve replacement (TAVR). The sufficient ring stability to support the implanted TAVR-prosthesis and the fact that the elliptical shape of the HAART-ring did not result in a problem concerning paravalvular leakage were important for the success of this procedure.
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http://dx.doi.org/10.1016/j.athoracsur.2020.03.090DOI Listing
November 2020

Current trends of sutureless and rapid deployment valves: an 11-year experience from the Sutureless and Rapid Deployment International Registry.

Eur J Cardiothorac Surg 2020 11;58(5):1054-1062

Cardiac Surgery Unit, Lancisi Cardiovascular Center, Polytechnic University of Marche, Ospedali Riuniti, Ancona, Italy.

Objectives: Current evidence on sutureless and rapid deployment aortic valve replacement (SURD-AVR) is limited and does not allow for the assessment of the clinical impact and the evolution of procedural and clinical outcomes of this new valve technology. The Sutureless and Rapid Deployment International Registry (SURD-IR) represents a unique opportunity to evaluate the current trends and outcomes of SURD-AVR interventions.

Methods: Data from 3682 patients enrolled between 2007 and 2018 were analysed. Patients were divided according to the date of surgery into 6 equal groups and by the type of intervention: isolated SURD-AVR (n = 2472) and combined SURD-AVR (n = 1086).

Results: Across the 11-year study period, significant changes occurred in patient characteristics including a decrease in age and in estimated surgical risk. Less invasive approaches for isolated SURD-AVR increased considerably from 49.4% to 85.5%. The overall in-hospital mortality rate was 1.6% and 3.9% in isolated and combined procedures, respectively, with no change over time. The rate of perioperative stroke decreased significantly (from 4% to 0.5%), as did the rates of postoperative pacemaker implantation (from 12.8% to 5.9%) and aortic regurgitation (from 17.8% to 2.7%).

Conclusions: The present study provides a comprehensive analysis of the current trends and results of SURD-AVR interventions. The most notable changes over time were the increasing implantation of SURD valves in a younger population, with more frequent utilization of less invasive techniques. SURD-AVR demonstrated remarkable improvements in clinical outcomes with a significant reduction in the rates of stroke, pacemaker implantation and postoperative aortic regurgitation.
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http://dx.doi.org/10.1093/ejcts/ezaa144DOI Listing
November 2020

Two approaches-one phenomenon-thrombocytopenia after surgical and transcatheter aortic valve replacement.

J Card Surg 2020 Jun 29;35(6):1186-1194. Epub 2020 Apr 29.

Cardiac Surgery Unit, Department of Experimental and Clinical Science, Magna Graecia, University of Catanzaro, Catanzaro, Italy.

Backgropund And Aim: Postoperative thrombocytopenia after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) and aggravating causes were the aim of this retrospective study.

Methods: Data of all patients treated with SAVR (n = 1068) and TAVR (n = 816) due to severe aortic valve stenosis was collected at our center from 2010 to 2017. Preprocedural and postprocedural values were collected from electronic patient records.

Results: There was a significant drop in platelets in both groups, the TAVR group showed overall superior platelet preservation compared to the AVR group (P < .001). In the SAVR subgroup analysis, a significant difference in platelet preservation was observed between the valve types (P < .001), particularly with the Freedom SOLO valve. In the TAVR subgroup analysis, the valve type did not influence platelet count (PLT) reduction (P = .13). In the SAVR subgroup analyses, PLT was found to be worsened with cardiopulmonary bypass (CPB) duration.

Conclusion: Thrombocytopenia frequently occurs after implantation of a biological heart valve prosthesis, with a higher frequency observed in patients after cardiac surgery rather than TAVR. Although some surgical bioprosthetic models are more susceptible to this phenomenon, CPB duration seems to be a major determinant for the development of postoperative thrombocytopenia.
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http://dx.doi.org/10.1111/jocs.14547DOI Listing
June 2020

Reply.

Ann Thorac Surg 2020 04 24;109(4):1307. Epub 2020 Jan 24.

Department of Cardiac Surgery, Paracelsus Medical University Nuremberg, Nuremberg, Germany; Department of Cardiac Surgery, Città di Lecce Hospital, GVM Care & Research, Lecce, Italy; Cardiac Surgery Unit, Department of Experimental and Clinical Science, "Magna Graecia" University, Catanzaro, Italy.

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http://dx.doi.org/10.1016/j.athoracsur.2019.08.117DOI Listing
April 2020

Preoperative risk stratification of deep sternal wound infection after coronary surgery.

Infect Control Hosp Epidemiol 2020 04 20;41(4):444-451. Epub 2020 Jan 20.

Department of Cardiac Surgery, St Anna Hospital, Catanzaro, Italy.

Objective: To develop a risk score for deep sternal wound infection (DSWI) after isolated coronary artery bypass grafting (CABG).

Design: Multicenter, prospective study.

Setting: Tertiary-care referral hospitals.

Participants: The study included 7,352 patients from the European multicenter coronary artery bypass grafting (E-CABG) registry.

Intervention: Isolated CABG.

Methods: An additive risk score (the E-CABG DSWI score) was estimated from the derivation data set (66.7% of patients), and its performance was assessed in the validation data set (33.3% of patients).

Results: DSWI occurred in 181 (2.5%) patients and increased 1-year mortality (adjusted hazard ratio, 4.275; 95% confidence interval [CI], 2.804-6.517). Female gender (odds ratio [OR], 1.804; 95% CI, 1.161-2.802), body mass index ≥30 kg/m2 (OR, 1.729; 95% CI, 1.166-2.562), glomerular filtration rate <45 mL/min/1.73 m2 (OR, 2.410; 95% CI, 1.413-4.111), diabetes (OR, 1.741; 95% CI, 1.178-2.573), pulmonary disease (OR, 1.935; 95% CI, 1.178-3.180), atrial fibrillation (OR, 1.854; 95% CI, 1.096-3.138), critical preoperative state (OR, 2.196; 95% CI, 1.209-3.891), and bilateral internal mammary artery grafting (OR, 2.088; 95% CI, 1.422-3.066) were predictors of DSWI (derivation data set). An additive risk score was calculated by assigning 1 point to each of these independent risk factors for DSWI. In the validation data set, the rate of DSWI increased along with the E-CABG DSWI scores (score of 0, 1.0%; score of 1, 1.8%; score of 2, 2.2%; score of 3, 6.9%; score ≥4: 12.1%; P < .0001). Net reclassification improvement, integrated discrimination improvement, and decision curve analysis showed that the E-CABG DSWI score performed better than other risk scores.

Conclusions: DSWI is associated with poor outcome after CABG, and its risk can be stratified using the E-CABG DSWI score.

Trial Registration: clinicaltrials.gov identifier: NCT02319083.
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http://dx.doi.org/10.1017/ice.2019.375DOI Listing
April 2020

Minimally Invasive Redo Aortic Valve Replacement: Results From a Multicentric Registry (SURD-IR).

Ann Thorac Surg 2020 08 16;110(2):553-557. Epub 2020 Jan 16.

Cardiac Surgery Unit, Department of Experimental and Clinical Medicine, Polytechnic University of Marche, Ospedali Riuniti, Ancona, Italy; The Collaborative Research (CORE) Group.

Background: Reoperation for aortic valve replacement can be challenging and is usually associated with an increased risk for complications and mortality. The study aim was to report the results of a multicenter cohort of patients who underwent minimally invasive reoperative aortic valve replacement with a sutureless or rapid-deployment prosthesis.

Methods: From 2007 to 2018 data from 3651 patients were retrospectively collected from the Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry. Of them, 63 patients who had previously undergone cardiac surgery represented the study population. In-hospital clinical and echocardiographic outcomes were recorded.

Results: Mean age of the selected 63 patients was 75.3 ± 7.8 years and logistic EuroSCORE 10.1. Surgery was performed by ministernotomy in 43 patients (68.3%) and by anterior right thoracotomy in 20 (31.7%); 31 patients (49.2%) received the Perceval valve (Livanova PLC, London, UK) and 32 (50.8%) the Intuity valve (Edwards Lifesciences, Irvine, CA). Mean cross-clamp time was 57.8 ± 23.2 minutes and cardiopulmonary bypass time 95.0 ± 34.3 minutes. Neither conversion to full sternotomy nor in-hospital deaths occurred. Postoperative events were ischemic cerebral events in 3 patients (4.8%), need for pacemaker implantation in 2 (3.6%), bleeding requiring reoperation in 5 (8.9%), and dialysis in 1 (1.6%). Median intensive care unit stay was 1 day, and median length of hospital stay was 10 days. On echocardiographic evaluation 1 patient showed a significant postoperative aortic regurgitation.

Conclusions: Minimally invasive reoperative aortic valve replacement with a sutureless or rapid-deployment prosthesis is a safe and feasible treatment strategy, resulting in fast recovery and improved postoperative outcome with no mortality and an acceptable complication rate.
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http://dx.doi.org/10.1016/j.athoracsur.2019.11.033DOI Listing
August 2020

Minimally Invasive Aortic Valve Replacement with Sutureless Valves: Results From an International Prospective Registry.

Innovations (Phila) 2020 Mar/Apr;15(2):120-130. Epub 2019 Dec 26.

267621 Ospedale del Cuore G. Pasquinucci, Massa, Italy.

Objective: To report the early and mid-term results of patients who underwent minimally invasive aortic valve replacement (MI-AVR) with a sutureless prosthesis from an international prospective registry.

Methods: Between March 2011 and September 2018, among 957 patients included in the prospective observational SURE-AVR (Sorin Universal REgistry on Aortic Valve Replacement) registry, 480 patients underwent MI-AVR with self-expandable Perceval aortic bioprosthesis (LivaNova PLC, London, UK) in 29 international institutions through either minithoracotomy ( = 266) or ministernotomy ( = 214). Postoperative, follow-up, and echocardiographic outcomes were analyzed for all patients.

Results: Patient age was 76.1 ± 7.1 years; 64.4% were female. Median EuroSCORE I was 7.9% (interquartile range [IQR], 4.8 to 10.9). Median cardiopulmonary bypass and cross-clamp times were 81 minutes (IQR 64 to 100) and 51 minutes (IQR 40 to 63). First successful implantation was achieved in 97.9% of cases. Two in-hospital deaths occurred, 1 for noncardiovascular causes and 1 following a disabling stroke. In the early (≤30 days) period, stroke rate was 1.4%. Three early explants were reported: 2 due to nonstructural valve dysfunction (NSVD) and 1 for malpositioning. One mild and 1 moderate paravalvular leak were reported. In 16 patients (3.3%) pacemaker implantation was needed. Mean follow-up was 2.4 years (maximum = 7 years). During follow-up 5 explants were reported, 3 due to endocarditis and 2 due to NSVD. Follow-up stroke rate was 2.5%. Three structural valve deteriorations not requiring reintervention were reported. Five-year survival was 91.45%.

Conclusions: In this large prospective international registry, MI-AVR with Perceval valve confirmed to be safe, reproducible, and effective in an intermediate-risk population, providing excellent clinical recovery both in early and mid-term follow-up.
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http://dx.doi.org/10.1177/1556984519892585DOI Listing
January 2021

Aortic valve calcification as a risk factor for major complications and reduced survival after transcatheter replacement.

J Cardiovasc Comput Tomogr 2020 Jul - Aug;14(4):307-313. Epub 2019 Dec 7.

Cardiac surgery, Cardiovascular Center, Paracelsus Medical University-Klinikum Nürnberg, Nuremberg, Germany.

Background: Aortic valve calcification is supposed to be a possible cause of embolic stroke or subclinical valve thrombosis after transcatheter aortic valve replacement (TAVR). We aimed to assess the role of aortic valve calcification in the occurrence of in-hospital clinical complications and survival after TAVR.

Methods: We retrospectively analyzed preoperative contrast-enhanced multidetector computed tomography scans of patients who underwent TAVR on the native aortic valve in our center. Calcium volume was calculated for each aortic cusp, above and below the aortic annulus. Outcomes were recorded according to VARC-2 criteria.

Results: Overall, 581 patients were included in the study (SapienXT = 192; Sapien3 = 228; CoreValve/EvolutR = 45; Engager = 5; Acurate = 111). Median survival was 4.98 years (interquartile range 4.41-5.54). Logistic regression identified calcium load beneath the right coronary cusp in left ventricular outflow tract (LVOT) as significantly associated with stroke (odds ratio [OR] 1.2; 95% confidence interval [CI] 1.03-1.3; p = 0.0019) and in-hospital mortality (OR 1.1; 95% CI 1.004-1.2; p = 0.04), whereas total calcium volume of the LVOT was associated with both in-hospital and 30 day-mortality (OR 1.2; 95% CI 1.01-1.4; p = 0.03, and OR 1.2; 95% CI 1.02-1.43; p = 0.029, respectively). Cox regression identified total calcium of LVOT (hazard ratio [HR] 1.18; 95% CI 1.02-1.38; p = 0.026), male sex (HR 1.88; 95% CI 1.06-3.32; p = 0.031), baseline creatinine clearance (HR 0.96; 95% CI 0.93-0.98; p < 0.001), and baseline severe aortic regurgitation (HR 7.48; 95% CI 2.76-20.26; p < 0.001) as risk factors associated with lower survival.

Conclusion: LVOT calcification is associated with increased risk of peri-procedural stroke and mortality as well as shorter long-term survival.
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http://dx.doi.org/10.1016/j.jcct.2019.12.001DOI Listing
September 2020