A 78-year-old woman was referred with refractory heart failure. She had previous surgical mitral ... more A 78-year-old woman was referred with refractory heart failure. She had previous surgical mitral valve repair with a 32 Carpentier-Edwards Physio ring (Edwards Lifesciences, Irvine, California) and a polypropylene Alfieri stitch. Echocardiography demonstrated restricted mitral valve leaflets, 2 eccentric regurgitant jets, and pulmonary vein flow reversal (Figure 1). Two orifices were evident on echocardiography and computed tomography (Figure 2).
Background: Transcatheter aortic valve replacement (TAVR) is an established treatment modality fo... more Background: Transcatheter aortic valve replacement (TAVR) is an established treatment modality for patients with aortic stenosis. Novel technological advancements have made this percutaneous minimally invasive therapy a first-line treatment for many patients at severe and most recently at intermediate risk for conventional cardiac surgery. However, despite this rising uptrend and technology improvements, vascular complications remain an Achilles heel for percutaneous aortic valve replacement. We set out to provide a comparative analysis of the incidence of vascular complications across first and second generation TAVR devices and their impact on clinical outcomes. Methods and results: An international, multi-centre registry was established to pursue collaborative research projects in the field of structural heart disease. Demographic, procedural and outcome data for the present study have been collected in 1018 patients undergoing TAVR. Vascular complications (minor or major) occurred in 245 patients (24%). At 30 day follow up, cardiovascular mortality was significant higher in the group with vascular complications (13% vs 4%; odds ratio (OR):1.37, 95% CI [1.06-1.77], p=0.01). Also cardiovascular mortality at one year remained higher in subjects with vascular complications (25% vs 16%; hazard ratio (HR): 1.15, 95% CI [1.0-1.33], p=0.05). When analyzed separately, as compared to the control group, mortality significantly increased in subjects who developed both major (37% vs 18%; (HR): 1.63, 95% CI [1.25-2.12],p<0.001) and minor vascular complications (28% vs 18%; (HR): 1.65, 95% CI [1.27-2.23], p=0.01). Conclusion: Vascular complications are a major determinant of mortality after TAVR. Mortality increases substantially after any provoked vascular damage irrespectively of whether this is major or minor. Efforts should be directed towards the minimize this complication to further improve survival after TAVR.
Cardiovascular Revascularization Medicine, May 1, 2019
Incidence, technical safety and feasibility of coronary angiography and intervention following se... more Incidence, technical safety and feasibility of coronary angiography and intervention following self-expanding transcatheter aortic valve replacement
The Journal of Thoracic and Cardiovascular Surgery, Aug 1, 2014
Objectives: With the introduction of the 31-mm Medtronic CoreValve prosthesis, patients with larg... more Objectives: With the introduction of the 31-mm Medtronic CoreValve prosthesis, patients with large aortic annulus have become eligible for transcatheter aortic valve implantation. The aim of this study was to evaluate the feasibility, efficacy, and safety of transcatheter aortic valve implantation using the 31-mm Medtronic CoreValve in patients with severe aortic valve stenosis and large aortic annulus. Methods: Five institutions in the Netherlands and Italy participated in a retrospective multicenter registry. Clinical, procedural, and imaging data of patients treated with the 31-mm Medtronic CoreValve were retrospectively collected in accordance with the Valve Academic Research Consortium-2 criteria. Results: Between August 2011 and November 2012, 47 patients (44 men, mean age 77.6 AE 8.9 years) received the 31-mm Medtronic CoreValve prosthesis for severe aortic stenosis. Device success (correct positioning of a single valve with intended performance and no all-cause 30-day mortality) was achieved in 31 patients (66.0%). Reasons for failing the device success criteria were significant prosthetic aortic regurgitation in 3 patients (6.4%), second valve implantation in 10 patients (21.2%) (8 cases of malpositioning with high-grade aortic regurgitation, 1 acute valve dislocation, and 1 delayed valve dislocation), 1 of whom died intrahospital, and in-hospital mortality in a further 3 patients (6.4%). Peak and mean transaortic gradients decreased significantly (P <.01). The rate of new pacemaker implantations was 41.7%. Conclusions: In this retrospective multicenter registry, transcatheter treatment of severe aortic valve stenosis with the 31-mm Medtronic CoreValve seemed to be challenging, even in experienced hands. If the prosthesis is properly implanted, it offers adequate valve hemodynamics and proper functioning.
Aim Transcatheter aortic valve implantation (TAVI) is a mainstay in the management of severe aort... more Aim Transcatheter aortic valve implantation (TAVI) is a mainstay in the management of severe aortic stenosis in patients with intermediate to prohibitive surgical risk. When a single TAVI device fails and cannot be retrieved, TAVI-in-TAVI must be performed acutely, but outcomes of bailout TAVI-in-TAVI have been incompletely appraised. We aimed at analyzing patient, procedural and outcome features of patients undergoing bailout TAVI-in-TAVI in a multicenter registry. Methods Details of patients undergoing bailout TAVI-in-TAVI, performed acutely or within 24 h of index TAVI, in 6 international high-volume institutions, were collected. For every case provided, 2 same-week consecutive controls (prior TAVI, and subsequent TAVI) were provided. Outcomes of interest were procedural and long-term events, including death, myocardial infarction, stroke, access site complication, major bleeding, and reintervention, and their composite (i.e. major adverse events [MAE]). Results A total of 106 patients undergoing bailout TAVI-in-TAVI were included, as well as 212 controls, for a total of 318 individuals. Bailout TAVI-in-TAVI was less common in younger patients, those with higher body mass index, or treated with Portico/Navitor or Sapien devices (all p < 0.05). Bailout TAVI-in-TAVI was associated with higher in-hospital rates of death, emergency surgery, MAE, and permanent pacemaker implantation (all p < 0.05). Long-term follow-up showed that bailout TAVI-in-TAVI was associated with higher rates of death and MAE (both < 0.05). Similar findings were obtained at adjusted analyses (all p < 0.05). However, censoring early events, outlook was not significantly different when comparing the two groups (p = 0.897 for death, and p = 0.645 for MAE). Conclusions Bail-out TAVI-in-TAVI is associated with significant early and long-term mortality and morbidity. Thus, meticulous preprocedural planning and sophisticated intraprocedural techniques are of paramount importance to avoid these emergency procedures.
European Heart Journal - Quality of Care and Clinical Outcomes
Aims Standardized data definitions are necessary for the quantification of quality of care and pa... more Aims Standardized data definitions are necessary for the quantification of quality of care and patient outcomes in observational studies and randomised controlled trials (RCTs). The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) project of the European Society of Cardiology (ESC) aims to create pan-European data standards for cardiovascular diseases and interventions, including transcatheter aortic valve implantation (TAVI). Methods and results We followed the EuroHeart methodology for cardiovascular data standard development. A Working Group of 29 members representing 12 countries was established and included a patient representative, as well as experts in the management of valvular heart disease from the European Association of Percutaneous Cardiovascular Interventions (EAPCI), the European Association of Cardiovascular Imaging (EACVI) and the Working Group on Cardiovascular Surgery. We conducted a systematic review of the literature and us...
OBJECTIVES The PREVAIL study evaluated the safety and effectiveness of a paclitaxel-coated percut... more OBJECTIVES The PREVAIL study evaluated the safety and effectiveness of a paclitaxel-coated percutaneous transluminal coronary angioplasty balloon catheter for the treatment of coronary de novo and in-stent restenosis (ISR) lesions in patients with symptomatic ischemic heart disease. METHODS PREVAIL was a prospective, multicenter, single-arm study that enrolled patients with clinical evidence of ischemia who had coronary lesions (de novo or first ISR) amenable to treatment with a drug-coated balloon (DCB). The study included 50 subjects (53 target lesions) who were treated with a Prevail DCB (Medtronic) during the index procedure and followed for 12 months. Mean lesion length was 14.5 ± 7.6 mm. The primary endpoint was in-stent (in-balloon) late lumen loss (LLL) by quantitative coronary angiography at 6 months post procedure. If the mean in-stent (in-balloon) LLL was less than the maximum acceptance rate of 0.50 mm at 6 months, then the study was considered successful. RESULTS Mean i...
Catheterization and Cardiovascular Interventions, 2020
COVID‐19 pandemic raised the issue to guarantee the proper level of care to patients with acute c... more COVID‐19 pandemic raised the issue to guarantee the proper level of care to patients with acute cardiovascular diseases and concomitant suspected or confirmed COVID‐19 and, in the meantime safety and protection of healthcare providers. The aim of this position paper is to provide standards to healthcare facilities and healthcare providers on infection prevention and control measures during the management of suspected and confirmed cases of 2019‐nCoV infection accessing in cath‐lab. The document represents the view of the Italian Society of Interventional Cardiology (GISE), and it is based on recommendations from the main World and European Health Organizations (WHO, and ECDC) as well as from the Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI).
High-grade conduction disturbances requiring permanent pacemaker (PPM) implantation occur in up t... more High-grade conduction disturbances requiring permanent pacemaker (PPM) implantation occur in up to 40% of patients following transcatheter aortic valve implantation (TAVI). The aim of this study was to identify pre-operative risk factors for PPM implantation after TAVI with the Medtronic CoreValve prosthesis (CVP). We retrospectively analysed 109 patients following transfemoral CVP implantation performed between 2008 and 2009 at the Leipzig Heart Center. Patients who had indwelling PPM at the time of TAVI (n ¼ 21) were excluded, leaving 88 patients for analysis. Mean age was 80.3 + 6.6 years and logistic EuroScore predicted risk of mortality was 23.3 + 12.1%. A total of 32 patients (36%) underwent PPM implantation post-TAVI during the same hospital admission. A total of 27/88 (31%) had evidence of pre-operative abnormal conduction, including first degree AV block and left bundle brunch block. Statistically significant risk factors for the need for post-operative PPM were patient age .75 years [P ¼ 0.02, odds ratio (OR) 4.6], pre-operative heart rate ,65 beats per minute (b.p.m.; P ¼ 0.04, OR 2.9), CVP oversizing .4 mm (P ¼ 0.03, OR 2.8), CVP prosthesis .26 mm (OR 2.2), atrial fibrillation (P ¼ 0.001, OR 5.2), and ventricular rate ,65 b.p.m. at the first post-operative day (P ¼ 0.137, OR 6.0). PPM implantation occurs frequently after transfemoral TAVI with the CVP. Older age, chronic atrial fibrillation, preoperative bradycardia, and larger or significantly oversized prostheses were independent risk factors for PPM implantation following TAVI with the CVP.
Journal of the American College of Cardiology, Sep 1, 2014
Background: Transcatheter aortic valve implantation (TAVI in patients with large aortic annuli (>... more Background: Transcatheter aortic valve implantation (TAVI in patients with large aortic annuli (>26mm) can be challenging and may be associated with suboptimal results, particularly as regards to post-procedural aortic regurgitation (AR). Recently, Direct Flow Medical (DFM) introduced the 29mm version of their fully repositionable and retrievable valve to treat aortic annuli measuring 26 to 28.5mm. Methods: All consecutive patients successfully implanted with a 29mm DFM valve between December 2013 and May 2014 were retrospectively analyzed in this multicenter European study. Endpoints were defined according to VARC-2 criteria periprocedurally and at 30 days. Results: A total of 36 high-and extreme-risk patients with severe aortic stenosis were implanted with a 29mmDFM valve. The mean age of patients was 82AE4.6 years and 90% were males. The average annular diameter and perimeter were 27.4AE1.2mm and 86.8AE3.4mm, respectively. The 29mm DFM was oversized in relation to the native annulus by 4.9%AE3.9% by diameter and 5.0%AE4.0% by perimeter. Implantation of the 29mm DFM resulted in a reduction of mean transaortic gradient from 41.9AE15.8mmHg to 6.1AE5.1mmHg. Device success was achieved in 97% of patients. Implantation of a DFM valve was associated with none or trivial AR in 81%, mild AR in 17%, and moderate AR in 1 (2%) patient. There were no coronary occlusions, device embolizations, annular rupture or intraprocedural deaths. Complete 30-day outcomes will be available and presented at the meeting. Conclusions: The Direct Flow Medical Transcatheter Aortic Valve System was associated with excellent peri-procedural outcomes and virtually eliminated AR in patients with aortic stenosis and a large annulus.
OBJECTIVES The management of severe aortic stenosis has been revolutionized by the introduction o... more OBJECTIVES The management of severe aortic stenosis has been revolutionized by the introduction of transcatheter aortic valve implantation (TAVI), especially in patients at intermediate, high, or prohibitive surgical risk. There is uncertainty, however, regarding the comparative effectiveness and safety of contemporary TAVI devices. METHODS We queried detailed data from the ongoing national Italian TAVI registry and compared baseline features, procedural details, and 12-month outcomes of Acurate Neo (Boston Scientific), Evolut Pro/R (Medtronic), Lotus (Boston Scientific), Portico (Abbott Vascular), and Sapien/ Sapien S3 Ultra (Edward Lifesciences) transcatheter aortic valves. Several endpoints were collected and appraised, including the composite of death, stroke, myocardial infarction (MI), major bleeding, major vascular complication, surgical aortic valve replacement and transcatheter aortic valve reimplantation, which were deemed major adverse events (MAEs). RESULTS A total of 1976 patients were included, with 234 treated with Acurate, 703 with Evolut, 151 with Lotus, 347 with Portico, and 541 with Sapien. Twelve-month events were not significantly different among the 5 devices, including death (P=.29) and MAE (P=.21), with the notable exception of major vascular complications, which were more common with Acurate and Sapien (P<.001) and permanent pacemaker implantation, which was more frequent with Lotus and Evolut (P<.001). Differences in MAE were more pronounced in women and subjects with prior cardiac surgery, with the lowest event rates in the Evolut group. Propensity-score adjusted analysis suggested that Acurate, Evolut, Portico, and Sapien were all associated with similarly favorable results, whereas adverse events were more evident with Lotus (P<.05). CONCLUSION Leading current-generation TAVI devices offer similarly favorable results at mid-term follow-up.
Cochrane Database of Systematic Reviews, Jul 20, 2005
The epidemic of cardiovascular disease and, in particular, of coronary heart disease, has started... more The epidemic of cardiovascular disease and, in particular, of coronary heart disease, has started several years ago (Pearson 1997), but despite large advances in prevention and management the global burden of these conditions will unfortunately increase in the next ...
Circulation-cardiovascular Interventions, Jun 1, 2021
Background: Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the ... more Background: Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the treatment of patients with severe aortic stenosis. However, the durability of bioprostheses is still a matter of concern, and little is known about the management of degenerated TAV. We sought to evaluate the outcomes of patients with a degenerated TAV treated by means of a second TAVR. Methods: The TRANSIT is an international registry that included cases of degenerated TAVR from 28 centers. Among around 40 000 patients treated with TAVR in the participating centers, 172 underwent a second TAVR: 57 (33%) for a mainly stenotic degenerated TAV, 97 (56%) for a mainly regurgitant TAV, and 18 (11%) for a combined degeneration. Overall, the rate of New York Heart Association class III/IV at presentation was 73.5%. Results: Valve Academic Research Consortium 2 device success rate was 79%, as a consequence of residual gradient (14%) or regurgitation (7%). At 1 month, the overall mortality rate was 2.9%, while rates of new hospitalization and New York Heart Association class III/IV were 3.6% and 7%, respectively, without significant difference across the groups. At 1 year, the overall mortality rate was 10%, while rates of new hospitalization and New York Heart Association class III/IV were 7.6% and 5.8%, respectively, without significant difference across the groups. No cases of valve thrombosis were recorded. Conclusions: Selected patients with a degenerated TAV may be safely and successfully treated by means of a second TAVR. This finding is of crucial importance for the adoption of the TAVR technology in a lower risk and younger population. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04500964.
In the last decade, transcatheter aortic valve (TAV) replacement determined a paradigm shift in t... more In the last decade, transcatheter aortic valve (TAV) replacement determined a paradigm shift in the treatment of patients with severe symptomatic aortic stenosis. Data on long-term TAV performance are still limited. We sought to evaluate the clinical and haemodynamic outcomes of the CoreValve self-expandable valve up to 8-year followup (FU).
A 78-year-old woman was referred with refractory heart failure. She had previous surgical mitral ... more A 78-year-old woman was referred with refractory heart failure. She had previous surgical mitral valve repair with a 32 Carpentier-Edwards Physio ring (Edwards Lifesciences, Irvine, California) and a polypropylene Alfieri stitch. Echocardiography demonstrated restricted mitral valve leaflets, 2 eccentric regurgitant jets, and pulmonary vein flow reversal (Figure 1). Two orifices were evident on echocardiography and computed tomography (Figure 2).
Background: Transcatheter aortic valve replacement (TAVR) is an established treatment modality fo... more Background: Transcatheter aortic valve replacement (TAVR) is an established treatment modality for patients with aortic stenosis. Novel technological advancements have made this percutaneous minimally invasive therapy a first-line treatment for many patients at severe and most recently at intermediate risk for conventional cardiac surgery. However, despite this rising uptrend and technology improvements, vascular complications remain an Achilles heel for percutaneous aortic valve replacement. We set out to provide a comparative analysis of the incidence of vascular complications across first and second generation TAVR devices and their impact on clinical outcomes. Methods and results: An international, multi-centre registry was established to pursue collaborative research projects in the field of structural heart disease. Demographic, procedural and outcome data for the present study have been collected in 1018 patients undergoing TAVR. Vascular complications (minor or major) occurred in 245 patients (24%). At 30 day follow up, cardiovascular mortality was significant higher in the group with vascular complications (13% vs 4%; odds ratio (OR):1.37, 95% CI [1.06-1.77], p=0.01). Also cardiovascular mortality at one year remained higher in subjects with vascular complications (25% vs 16%; hazard ratio (HR): 1.15, 95% CI [1.0-1.33], p=0.05). When analyzed separately, as compared to the control group, mortality significantly increased in subjects who developed both major (37% vs 18%; (HR): 1.63, 95% CI [1.25-2.12],p<0.001) and minor vascular complications (28% vs 18%; (HR): 1.65, 95% CI [1.27-2.23], p=0.01). Conclusion: Vascular complications are a major determinant of mortality after TAVR. Mortality increases substantially after any provoked vascular damage irrespectively of whether this is major or minor. Efforts should be directed towards the minimize this complication to further improve survival after TAVR.
Cardiovascular Revascularization Medicine, May 1, 2019
Incidence, technical safety and feasibility of coronary angiography and intervention following se... more Incidence, technical safety and feasibility of coronary angiography and intervention following self-expanding transcatheter aortic valve replacement
The Journal of Thoracic and Cardiovascular Surgery, Aug 1, 2014
Objectives: With the introduction of the 31-mm Medtronic CoreValve prosthesis, patients with larg... more Objectives: With the introduction of the 31-mm Medtronic CoreValve prosthesis, patients with large aortic annulus have become eligible for transcatheter aortic valve implantation. The aim of this study was to evaluate the feasibility, efficacy, and safety of transcatheter aortic valve implantation using the 31-mm Medtronic CoreValve in patients with severe aortic valve stenosis and large aortic annulus. Methods: Five institutions in the Netherlands and Italy participated in a retrospective multicenter registry. Clinical, procedural, and imaging data of patients treated with the 31-mm Medtronic CoreValve were retrospectively collected in accordance with the Valve Academic Research Consortium-2 criteria. Results: Between August 2011 and November 2012, 47 patients (44 men, mean age 77.6 AE 8.9 years) received the 31-mm Medtronic CoreValve prosthesis for severe aortic stenosis. Device success (correct positioning of a single valve with intended performance and no all-cause 30-day mortality) was achieved in 31 patients (66.0%). Reasons for failing the device success criteria were significant prosthetic aortic regurgitation in 3 patients (6.4%), second valve implantation in 10 patients (21.2%) (8 cases of malpositioning with high-grade aortic regurgitation, 1 acute valve dislocation, and 1 delayed valve dislocation), 1 of whom died intrahospital, and in-hospital mortality in a further 3 patients (6.4%). Peak and mean transaortic gradients decreased significantly (P <.01). The rate of new pacemaker implantations was 41.7%. Conclusions: In this retrospective multicenter registry, transcatheter treatment of severe aortic valve stenosis with the 31-mm Medtronic CoreValve seemed to be challenging, even in experienced hands. If the prosthesis is properly implanted, it offers adequate valve hemodynamics and proper functioning.
Aim Transcatheter aortic valve implantation (TAVI) is a mainstay in the management of severe aort... more Aim Transcatheter aortic valve implantation (TAVI) is a mainstay in the management of severe aortic stenosis in patients with intermediate to prohibitive surgical risk. When a single TAVI device fails and cannot be retrieved, TAVI-in-TAVI must be performed acutely, but outcomes of bailout TAVI-in-TAVI have been incompletely appraised. We aimed at analyzing patient, procedural and outcome features of patients undergoing bailout TAVI-in-TAVI in a multicenter registry. Methods Details of patients undergoing bailout TAVI-in-TAVI, performed acutely or within 24 h of index TAVI, in 6 international high-volume institutions, were collected. For every case provided, 2 same-week consecutive controls (prior TAVI, and subsequent TAVI) were provided. Outcomes of interest were procedural and long-term events, including death, myocardial infarction, stroke, access site complication, major bleeding, and reintervention, and their composite (i.e. major adverse events [MAE]). Results A total of 106 patients undergoing bailout TAVI-in-TAVI were included, as well as 212 controls, for a total of 318 individuals. Bailout TAVI-in-TAVI was less common in younger patients, those with higher body mass index, or treated with Portico/Navitor or Sapien devices (all p < 0.05). Bailout TAVI-in-TAVI was associated with higher in-hospital rates of death, emergency surgery, MAE, and permanent pacemaker implantation (all p < 0.05). Long-term follow-up showed that bailout TAVI-in-TAVI was associated with higher rates of death and MAE (both < 0.05). Similar findings were obtained at adjusted analyses (all p < 0.05). However, censoring early events, outlook was not significantly different when comparing the two groups (p = 0.897 for death, and p = 0.645 for MAE). Conclusions Bail-out TAVI-in-TAVI is associated with significant early and long-term mortality and morbidity. Thus, meticulous preprocedural planning and sophisticated intraprocedural techniques are of paramount importance to avoid these emergency procedures.
European Heart Journal - Quality of Care and Clinical Outcomes
Aims Standardized data definitions are necessary for the quantification of quality of care and pa... more Aims Standardized data definitions are necessary for the quantification of quality of care and patient outcomes in observational studies and randomised controlled trials (RCTs). The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) project of the European Society of Cardiology (ESC) aims to create pan-European data standards for cardiovascular diseases and interventions, including transcatheter aortic valve implantation (TAVI). Methods and results We followed the EuroHeart methodology for cardiovascular data standard development. A Working Group of 29 members representing 12 countries was established and included a patient representative, as well as experts in the management of valvular heart disease from the European Association of Percutaneous Cardiovascular Interventions (EAPCI), the European Association of Cardiovascular Imaging (EACVI) and the Working Group on Cardiovascular Surgery. We conducted a systematic review of the literature and us...
OBJECTIVES The PREVAIL study evaluated the safety and effectiveness of a paclitaxel-coated percut... more OBJECTIVES The PREVAIL study evaluated the safety and effectiveness of a paclitaxel-coated percutaneous transluminal coronary angioplasty balloon catheter for the treatment of coronary de novo and in-stent restenosis (ISR) lesions in patients with symptomatic ischemic heart disease. METHODS PREVAIL was a prospective, multicenter, single-arm study that enrolled patients with clinical evidence of ischemia who had coronary lesions (de novo or first ISR) amenable to treatment with a drug-coated balloon (DCB). The study included 50 subjects (53 target lesions) who were treated with a Prevail DCB (Medtronic) during the index procedure and followed for 12 months. Mean lesion length was 14.5 ± 7.6 mm. The primary endpoint was in-stent (in-balloon) late lumen loss (LLL) by quantitative coronary angiography at 6 months post procedure. If the mean in-stent (in-balloon) LLL was less than the maximum acceptance rate of 0.50 mm at 6 months, then the study was considered successful. RESULTS Mean i...
Catheterization and Cardiovascular Interventions, 2020
COVID‐19 pandemic raised the issue to guarantee the proper level of care to patients with acute c... more COVID‐19 pandemic raised the issue to guarantee the proper level of care to patients with acute cardiovascular diseases and concomitant suspected or confirmed COVID‐19 and, in the meantime safety and protection of healthcare providers. The aim of this position paper is to provide standards to healthcare facilities and healthcare providers on infection prevention and control measures during the management of suspected and confirmed cases of 2019‐nCoV infection accessing in cath‐lab. The document represents the view of the Italian Society of Interventional Cardiology (GISE), and it is based on recommendations from the main World and European Health Organizations (WHO, and ECDC) as well as from the Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI).
High-grade conduction disturbances requiring permanent pacemaker (PPM) implantation occur in up t... more High-grade conduction disturbances requiring permanent pacemaker (PPM) implantation occur in up to 40% of patients following transcatheter aortic valve implantation (TAVI). The aim of this study was to identify pre-operative risk factors for PPM implantation after TAVI with the Medtronic CoreValve prosthesis (CVP). We retrospectively analysed 109 patients following transfemoral CVP implantation performed between 2008 and 2009 at the Leipzig Heart Center. Patients who had indwelling PPM at the time of TAVI (n ¼ 21) were excluded, leaving 88 patients for analysis. Mean age was 80.3 + 6.6 years and logistic EuroScore predicted risk of mortality was 23.3 + 12.1%. A total of 32 patients (36%) underwent PPM implantation post-TAVI during the same hospital admission. A total of 27/88 (31%) had evidence of pre-operative abnormal conduction, including first degree AV block and left bundle brunch block. Statistically significant risk factors for the need for post-operative PPM were patient age .75 years [P ¼ 0.02, odds ratio (OR) 4.6], pre-operative heart rate ,65 beats per minute (b.p.m.; P ¼ 0.04, OR 2.9), CVP oversizing .4 mm (P ¼ 0.03, OR 2.8), CVP prosthesis .26 mm (OR 2.2), atrial fibrillation (P ¼ 0.001, OR 5.2), and ventricular rate ,65 b.p.m. at the first post-operative day (P ¼ 0.137, OR 6.0). PPM implantation occurs frequently after transfemoral TAVI with the CVP. Older age, chronic atrial fibrillation, preoperative bradycardia, and larger or significantly oversized prostheses were independent risk factors for PPM implantation following TAVI with the CVP.
Journal of the American College of Cardiology, Sep 1, 2014
Background: Transcatheter aortic valve implantation (TAVI in patients with large aortic annuli (>... more Background: Transcatheter aortic valve implantation (TAVI in patients with large aortic annuli (>26mm) can be challenging and may be associated with suboptimal results, particularly as regards to post-procedural aortic regurgitation (AR). Recently, Direct Flow Medical (DFM) introduced the 29mm version of their fully repositionable and retrievable valve to treat aortic annuli measuring 26 to 28.5mm. Methods: All consecutive patients successfully implanted with a 29mm DFM valve between December 2013 and May 2014 were retrospectively analyzed in this multicenter European study. Endpoints were defined according to VARC-2 criteria periprocedurally and at 30 days. Results: A total of 36 high-and extreme-risk patients with severe aortic stenosis were implanted with a 29mmDFM valve. The mean age of patients was 82AE4.6 years and 90% were males. The average annular diameter and perimeter were 27.4AE1.2mm and 86.8AE3.4mm, respectively. The 29mm DFM was oversized in relation to the native annulus by 4.9%AE3.9% by diameter and 5.0%AE4.0% by perimeter. Implantation of the 29mm DFM resulted in a reduction of mean transaortic gradient from 41.9AE15.8mmHg to 6.1AE5.1mmHg. Device success was achieved in 97% of patients. Implantation of a DFM valve was associated with none or trivial AR in 81%, mild AR in 17%, and moderate AR in 1 (2%) patient. There were no coronary occlusions, device embolizations, annular rupture or intraprocedural deaths. Complete 30-day outcomes will be available and presented at the meeting. Conclusions: The Direct Flow Medical Transcatheter Aortic Valve System was associated with excellent peri-procedural outcomes and virtually eliminated AR in patients with aortic stenosis and a large annulus.
OBJECTIVES The management of severe aortic stenosis has been revolutionized by the introduction o... more OBJECTIVES The management of severe aortic stenosis has been revolutionized by the introduction of transcatheter aortic valve implantation (TAVI), especially in patients at intermediate, high, or prohibitive surgical risk. There is uncertainty, however, regarding the comparative effectiveness and safety of contemporary TAVI devices. METHODS We queried detailed data from the ongoing national Italian TAVI registry and compared baseline features, procedural details, and 12-month outcomes of Acurate Neo (Boston Scientific), Evolut Pro/R (Medtronic), Lotus (Boston Scientific), Portico (Abbott Vascular), and Sapien/ Sapien S3 Ultra (Edward Lifesciences) transcatheter aortic valves. Several endpoints were collected and appraised, including the composite of death, stroke, myocardial infarction (MI), major bleeding, major vascular complication, surgical aortic valve replacement and transcatheter aortic valve reimplantation, which were deemed major adverse events (MAEs). RESULTS A total of 1976 patients were included, with 234 treated with Acurate, 703 with Evolut, 151 with Lotus, 347 with Portico, and 541 with Sapien. Twelve-month events were not significantly different among the 5 devices, including death (P=.29) and MAE (P=.21), with the notable exception of major vascular complications, which were more common with Acurate and Sapien (P<.001) and permanent pacemaker implantation, which was more frequent with Lotus and Evolut (P<.001). Differences in MAE were more pronounced in women and subjects with prior cardiac surgery, with the lowest event rates in the Evolut group. Propensity-score adjusted analysis suggested that Acurate, Evolut, Portico, and Sapien were all associated with similarly favorable results, whereas adverse events were more evident with Lotus (P<.05). CONCLUSION Leading current-generation TAVI devices offer similarly favorable results at mid-term follow-up.
Cochrane Database of Systematic Reviews, Jul 20, 2005
The epidemic of cardiovascular disease and, in particular, of coronary heart disease, has started... more The epidemic of cardiovascular disease and, in particular, of coronary heart disease, has started several years ago (Pearson 1997), but despite large advances in prevention and management the global burden of these conditions will unfortunately increase in the next ...
Circulation-cardiovascular Interventions, Jun 1, 2021
Background: Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the ... more Background: Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the treatment of patients with severe aortic stenosis. However, the durability of bioprostheses is still a matter of concern, and little is known about the management of degenerated TAV. We sought to evaluate the outcomes of patients with a degenerated TAV treated by means of a second TAVR. Methods: The TRANSIT is an international registry that included cases of degenerated TAVR from 28 centers. Among around 40 000 patients treated with TAVR in the participating centers, 172 underwent a second TAVR: 57 (33%) for a mainly stenotic degenerated TAV, 97 (56%) for a mainly regurgitant TAV, and 18 (11%) for a combined degeneration. Overall, the rate of New York Heart Association class III/IV at presentation was 73.5%. Results: Valve Academic Research Consortium 2 device success rate was 79%, as a consequence of residual gradient (14%) or regurgitation (7%). At 1 month, the overall mortality rate was 2.9%, while rates of new hospitalization and New York Heart Association class III/IV were 3.6% and 7%, respectively, without significant difference across the groups. At 1 year, the overall mortality rate was 10%, while rates of new hospitalization and New York Heart Association class III/IV were 7.6% and 5.8%, respectively, without significant difference across the groups. No cases of valve thrombosis were recorded. Conclusions: Selected patients with a degenerated TAV may be safely and successfully treated by means of a second TAVR. This finding is of crucial importance for the adoption of the TAVR technology in a lower risk and younger population. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04500964.
In the last decade, transcatheter aortic valve (TAV) replacement determined a paradigm shift in t... more In the last decade, transcatheter aortic valve (TAV) replacement determined a paradigm shift in the treatment of patients with severe symptomatic aortic stenosis. Data on long-term TAV performance are still limited. We sought to evaluate the clinical and haemodynamic outcomes of the CoreValve self-expandable valve up to 8-year followup (FU).
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