Paolo Biglioli’s research while affiliated with Centro Cardiologico Monzino and other places

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Publications (150)


Transcatheter vs. surgical aortic valve replacement
  • Article

April 2012

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48 Reads

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28 Citations

Journal of Cardiovascular Medicine

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Manuela Muratori

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[...]

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Paolo Biglioli

To compare, in terms of clinical effectiveness and safety, patients who underwent transcatheter aortic valve implantation (TAVI) with those who underwent surgical aortic valve replacement (S-AVR) for the treatment of severe aortic stenosis during the same period. One hundred and eighty-seven consecutive patients were included: 81 with S-AVR and 106 with TAVI. Primary and secondary outcomes were reported in accordance with published reporting guidelines for valve surgery. A propensity matching model was computed in the attempt to reduce confounding effects of covariates. Thirty-day mortality and morbidity, as well as follow-up events, did not differ between the two therapeutic options, except for ICU stay, in favor of TAVI, and occurrence of pleural effusions, in favor of S-AVR. TAVI accomplished significant mean aortic gradient reduction (better than S-AVR in the immediate postoperative and at least comparable at follow-up) and improvement in valve area and functional class (always higher than S-AVR). Although for the first year, survival was at least comparable between TAVI and S-AVR (both whole and matched groups); at later times, TAVI all-cause and noncardiac mortality was higher in the whole sample, as expected from age and comorbidities of TAVI patients. At later follow-up, in the matched subsamples, 1-year mortality rates were replicated, with a significantly higher incidence of cardiac deaths in S-AVR patients. TAVI morbidity and mortality registered in this series are lower than those estimated for conventional surgery in high-risk patients and compare to those associated with S-AVR in good surgical candidates.


Figure 1: Scatterplot showing the correlation between body mass index and the effective dose during a TEVAR procedure. A trend line with the corresponding Pearson coefficient (r) and significance value ( p) is depicted. 
Figure 2: Stacked histogram depicting the cumulative radiation exposure of a patient undergoing a TEVAR procedure and adhering to the suggested followup. The proportional contribution of the three different imaging methods to the cumulative RE is depicted. 
Cumulative radiation exposure during thoracic endovascular aneurysm repair and subsequent follow-up
  • Article
  • Full-text available

January 2012

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66 Reads

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36 Citations

European journal of cardio-thoracic surgery: official journal of the European Association for Cardio-thoracic Surgery

Thoracic endovascular aneurysm repair (TEVAR) is an appealing alternative to the standard surgical approach, but requires rigorous radiological follow-up. The cumulative radiation exposure (RE) of patients undergoing TEVAR-including pre-operative workup, the procedure and subsequent follow-up computed tomography (CT) imaging-has not previously been investigated. From August 2003 to February 2011, 48 patients underwent TEVAR at our institution. Mean age was 66 ± 11 years, with 10 patients (21%) aged <60 years. Forty-one (85%) patients were male; 7 (15%) had urgent/emergent operation; 21 (44%) had undergone previous aortic surgery. Mean aortic diameter was 7.3 ± 2.1 cm. Intra-operative screening time and RE were reviewed, and typical institutional thoracic CT scan RE was calculated (17.8 mSv). Life expectancy of an age- and sex-matched population was estimated to assess the cumulative RE from recurrent CT follow-up. The average screening time was 15.7 ± 11.4 min, with an RE of 11.3 ± 9 mSv. Obese patients had significantly higher RE during TEVAR (Pearson's coefficient = 0.388, P = 0.019). The RE dropped from 14.9 ± 9.4 mSv to 8.6 ± 7.9 mSv (P = 0.033) after a hybrid suite was established. Our institutional TEVAR protocol involves one pre-operative thoracoabdominal CT scan and three follow-up thoracic CT scans for the first year, with a yearly evaluation thereafter. The life expectancy of an age- and sex-matched population was 17 years. A patient adhering to our surveillance protocol would be subjected to an overall exposure of 89 mSv at 1 year and 161 mSv at 5 years, with a projected lifetime RE >350 mSv. A 2-year RE exceeding the threshold of 100 mSv with a life expectancy >15 years can be estimated to lead to a lifetime risk increase in radiation-induced leukaemia and solid-tumour cancer >2.7%. The risks of cumulative RE especially in younger and/or obese patients must be balanced with the expected morbidity and mortality reduction in TEVAR versus traditional open repair, and the anticipated benefits of recurrent radiographic imaging.

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Case Series of Bail-Out Procedures With a Balloon-Expandable Sheath After Unsuccessful Introduction of the NovaFlex Device

January 2012

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39 Reads

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3 Citations

Innovations Technology and Techniques in Cardiothoracic and Vascular Surgery

Vascular complications remain the main problem of transcatheter aortic valve replacement, despite downsizing of delivery catheter diameter and judicious patient selection. In case of diffusely calcified and/or very tortuous access vessels, the SoloPath Balloon Expandable TransFemoral Introducer (Onset Medical Corporation, Irvine, CA USA), providing the smallest insertion profile of any sheath in its class, may enable exceptional trackability and offer the largest working diameter, thus helping to prevent feared vascular complications. We report the successful use of SoloPath sheath to face six cases of NovaFlex (Edwards Lifesciences Inc, Irvine, CA USA) sheath failed insertion due to vessel tortuosity and calcifications. In six patients enrolled for transfemoral transcatheter Edwards SAPIEN XT replacement, resistance to NovaFlex sheath pushing was encountered, subsequent to the bending of the distal portion of the sheath due to vessel tortuosity and calcifications. Damaged Edwards sheaths were exchanged for a SoloPath sheath with a 21-French inner diameter. SoloPath Controlled Deployment Technology design provides the introducer, once expanded, with great radial and pillar resistance. The unexpanded SoloPath sheath-dilator combination tracked without resistance or kinking over a stiff guide wire through the iliofemoral axis and then was expanded. All transcatheter prostheses were successfully deployed within the native annulus, showing good hemodynamic function. We report six successful bail-out procedures with the SoloPath Balloon Expandable TransFemoral sheath after unsuccessful introduction of the NovaFlex device. If similar results are confirmed, use of the SoloPath during transcatheter aortic valve replacement may help prevent vascular complications and eliminate the need for other preoperative steps (eg, vascular stenting), therefore reducing procedural mortality, surgical expense, and patient recovery time.


Transapical Aortic Valve Implantation in High-Risk Patients With Severe Aortic Valve Stenosis

November 2011

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26 Reads

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19 Citations

The Annals of Thoracic Surgery

Transapical aortic valve implantation (TA-TAVI) represents an alternative in patients with symptomatic severe aortic valve stenosis (SSAVS) who cannot be operated on or have a high surgical risk. The aim of this prospective multicenter observational study was to assess early and 2-year clinical and hemodynamic outcomes after TA-TAVI. From May 2008 to September 2010, 179 patients with inoperable conditions or high-risk patients underwent TA-TAVI at 4 institutions. Indications for TA-TAVI were SSAVS and logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) greater than 20% or porcelain aorta in patients with severe aortoiliac disease. Patients underwent clinical and echocardiographic follow-up visits at hospital discharge, 3 and 6 months after TA-TAVI, and every 6 months thereafter. The impact of the learning curve for the centers and of intraoperative complications on patient outcomes was also evaluated. Mean age was 81 ± 6 years. Mean logistic EuroSCORE was 22% ± 12%. Transapical delivery was successful in all patients. Seventeen severe intraoperative complications occurred in 13 (7.3%) patients. Thirty-day mortality was 3.9% (7 patients). Mean follow-up was 9.2 ± 6.5 months. Late mortality occurred in 9 patients. Two-year survival was 88% ± 3%. An intraoperative severe complication was identified as the only significant independent predictor of 1-year mortality. A significant benefit was found when comparing 2-year survival of the second versus the first 50% patients at each center (93% ± 2% versus 84% ± 3 %; p = 0.046). A significant reduction of both mean and peak gradients from the preoperative to the postoperative period, which remained stable during follow-up, was found. TA-TAVI provides excellent early and 2-year results in terms of survival, valve-related adverse events, and hemodynamic performance. Survival after TA-TAVI is affected by the center learning curve and by the occurrence of an intraoperative complication.


Table 1 dose of colchicine in pericardial effusion 
Recurrent pericardial effusion after cardiac surgery: The use of colchicine after recalcitrant conventional therapy

August 2011

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443 Reads

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11 Citations

Journal of Cardiothoracic Surgery

Pericardial effusion represents a common postoperative complication in cardiac surgery. Nonetheless, it can be resistant to conventional therapy leading to prolonged in-hospital stay and worsening of clinical conditions. Recent literature shows that colchicine therapy should be useful in the treatment of recurrent post surgical pericardial effusion. Hereby we report the case of a patient with postsurgical recurrent effusion treated with colchicine, and a review of literature concerning the use of this old drug.


Feasibility and accuracy of a comprehensive multidetector computed tomography acquisition for patients referred for balloon-expandable transcatheter aortic valve implantation

June 2011

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20 Reads

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88 Citations

American Heart Journal

The aim of this study was to assess the accuracy of a comprehensive multidetector computed tomography (MDCT) evaluation of the aortic annulus (AoA), coronary artery disease (CAD), and peripheral vessels in patients referred for transcatheter aortic valve implantation (TAVI). In 60 patients referred for TAVI, the following parameters were assessed with 64-slices MDCT and compared with transesophageal echocardiography (TEE), invasive coronary angiography (ICA), and peripheral angiography: AoA maximum diameter (Max-AoA-D(MDCT)), minimum diameter (Min-AoA-D(MDCT)), and area; lumen morphology index ([Max-AoA-D(MDCT)/Min-AoA-D(MDCT)]); length of the left, right, and non-coronary aortic leaflets; degree (grades 1-4) of aortic leaflet calcifications; distance between AoA and left main coronary ostium and between AoA and right coronary ostium CAD and peripheral vessel disease. The Max-AoA-D(MDCT) and Min-AoA-D(MDCT) were 25.1 ± 2.8 and 21.2 ± 2.2 mm, respectively, with high correlation versus AoA diameter measured with TEE (r = 0.82 and 0.86, respectively). The area of AoA, systolic and diastolic lumen morphology index were 410 ± 81.5 mm(2), 1.19 ± 0.1 and 1.22 ± 0.11, respectively. Aortic leaflet calcification score was 3.3 ± 0.5. The lengths of left, right, and non-coronary aortic leaflets were 14.2 ± 2.4, 13.7.1 ± 2.1, and 14.5 ± 2.6 mm, whereas distances between AoA and the left main coronary ostium and between AoA, and the right coronary ostium were 13.7 ± 2.9 and 15.8 ± 3.5 mm, respectively. Feasibility, negative predictive value, and accuracy for CAD detection versus ICA were 87%, 100% (CI 100-100), and 96% (95% CI 94-100), respectively. All patients (N = 17) who were ineligible for TAVI were correctly detected by MDCT. A comprehensive MDCT evaluation of patients referred for TAVI is feasible, provides more accurate assessment than TEE of AoA morphology, and may replace peripheral angiography in all patients and ICA in patients without significant CAD.


Conservative management of the pseudoaneurysms of ascending aortic graft: A case of spontaneous regression at follow-up

May 2011

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28 Reads

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8 Citations

Journal of Cardiovascular Medicine

Pseudoaneurysms of thoracic aorta represent life-threatening complications of cardiac surgery. We present a case report of a patient who underwent urgent aortic valvular replacement with a biological prosthesis and ascending aortic replacement with graft interposition and developed postoperative ascending aortic pseudoaneurysms. The pseudoaneurysms did not increase in the postoperative stay and a conservative management was chosen. At follow-up, the two pseudoaneurysms had completely regressed. The therapeutic steps for aortic pseudoaneurysms should be tailored to the patient and even conservative management could be effective if selected after an evaluation of the clinical status of the patient.


Traitement endovasculaire d’un anévrysme de l’aorte abdominale après pneumonectomie gauche : Un bon choix

May 2011

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16 Reads

Annales de Chirurgie Vasculaire

Le traitement chirurgical d’un anévrysme de l’aorte abdominale après pneumonectomie est un défi en raison de la fonction respiratoire altérée et des risques chirurgicaux accrus. Le traitement endovasculaire chez les patients anatomiquement adaptés à haut risque-chirurgical offre d’excellents résultats à court terme et assure une bonne protection contre le décès lié à l’anévrysme. Dans cet article, nous rapportons le traitement endovasculaire d’un anévrysme de l’aorte sous-rénale chez un patient ayant eu une pneumonectomie.


Endovascular Treatment of Abdominal Aortic Aneurysm After Previous Left Pneumonectomy: A Sound Choice

March 2011

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22 Reads

Annals of Vascular Surgery

Surgical treatment of abdominal aortic aneurysm after previous pneumonectomy is a challenge because of the impaired respiratory function and increased surgical risks. Endovascular aneurysm repair in anatomically suited high-surgical-risk patients offers excellent short-term results and provides good protection from aneurysm-related death. In this article, we report a successful endovascular aneurysm repair of an infrarenal aortic aneurysm in a patient with past left pneumonectomy.


Citations (76)


... Experience with balloon-expandable, non-re-collapsible and re-collapsible sheaths have been described in isolated case reports and small case series, but their femoral access thresholds were larger and sample sizes smaller than our study (Table V). Fusari and colleagues [21] in 2012 published their early experience with a 21-French balloon-expandable, non-re-collapsible Solopath sheath in six patients undergoing TAVR and concluded that it should not be used in noncalcified arteries <7 mm in diameter or calcified arteries <8 mm. Dimitriadis and colleagues reported eight TF-TAVR cases in which an 11/19-French balloonexpandable, non-re-collapsible Solopath sheath was used, with one major vascular complication [22]. ...

Reference:

Vascular complication can be minimized with a balloon-expandable, re-collapsible sheath in TAVR with a self-expanding bioprosthesis
Case Series of Bail-Out Procedures with a Balloon-Expandable Sheath after Unsuccessful Introduction of the NovaFlex Device
  • Citing Article
  • January 2012

Innovations Technology and Techniques in Cardiothoracic and Vascular Surgery

... The process of cryopreservation and subsequent thawing results in various changes in the valvular and vascular tissue as listed here; a. morphologic changes: mainly manifested as fractures; both macroscopic and microscopic [36][37][38], b. metabolic changes: manifested by the change in the concentrations and composition of glycosoaminoglycans [39], c. antigenic changes: cryopreservation results in the loss of endothelial cells in a vascular graft which may result in a decrease in antigenicity [40]. ...

CRYOPRESERVATION OF PORCINE AORTIC VALVE: OPEN STATUS OF THE AORTIC LEAFLETS RESULTS IN INCREASED MATRIX GLYCOSAMINOGLYCANS STRUCTURAL MAINTENANCE
  • Citing Chapter
  • April 2004

... They showed that both patency and number of distal anastomoses are lower in OPCAB, which confirms and ex-tends previous evidence published by our group concerning reduced patency rates. [2][3][4] The OPCAB technique was developed and reintroduced in the clinical practice for economic reasons in some southern America countries more than a decade ago, and then it became progressively adopted by European and North America centers to reduce trauma, thus rendering coronary bypass surgery an easier choice compared with less invasive options (eg, interventional cardiologic procedures). ...

Does off-pump coronary artery bypass graft surgery increase risk of graft occlusion? Reply
  • Citing Article
  • August 2006

The Annals of Thoracic Surgery

... Experience with balloon-expandable, non-re-collapsible and re-collapsible sheaths have been described in isolated case reports and small case series, but their femoral access thresholds were larger and sample sizes smaller than our study (Table V). Fusari and colleagues[21]in 2012 published their early experience with a 21-French balloon-expandable, non-re-collapsible Solopath sheath in six patients undergoing TAVR and concluded that it should not be used in noncalcified arteries <7 mm in diameter or calcified arteries <8 mm. Dimitriadis and colleagues reported eight TFTAVR cases in which an 11/19-French balloonexpandable, non-re-collapsible Solopath sheath was used, with one major vascular complication[22]. ...

Case Series of Bail-Out Procedures With a Balloon-Expandable Sheath After Unsuccessful Introduction of the NovaFlex Device
  • Citing Article
  • January 2012

Innovations Technology and Techniques in Cardiothoracic and Vascular Surgery

... 20,21 Histopathological examination of excised ventricular wall helps to confirm the diagnosis of this disease. 22,23 Unlike true aneurysms, which are regions of dilated ventricle encompassing all the layers (i.e. the endocardium, myocardium and epicardium), ventricular pseudoaneurysms affect only the epicardium and are often contained by the serosal layer of the pericardium. 1,24 Histopathologic examination was performed in our case and PSA diagnosis was confirmed. ...

An unusual case of large left ventricular aneurysm: Complementary role of echocardiography and multidetector computed tomography in surgical planning
  • Citing Article
  • May 2005

European Journal of Radiology Extra

... Surgical Aortic Valve Replacement (SAVR) is the traditional approach to treating AS [3]. In recent years, transcatheter aortic valve replacement (TAVR) has emerged as a formidable alternative, offering less invasive intervention with a rapidly expanding body of evidence supporting its efficacy and safety in high-risk and intermediate-risk patient populations [4,5]. Despite this, TAVR's role in younger and lower-risk patients or those with specific challenges like a small aortic annulus (SAA) remains under intense debate, with a preference for SAVR as the standard treatment approach [5,6]. ...

Transcatheter vs. surgical aortic valve replacement
  • Citing Article
  • April 2012

Journal of Cardiovascular Medicine

... Radiation effects of endovascular procedures are broadly grouped into two categories: deterministic effects and stochastic effects. 2 Deterministic effects on cells can be seen once a threshold amount of radiation exposure has been reached 3 and follow a standard doseresponse curve. 4 A stochastic effect is due to a random mutation in a cell induced by radiation damaged prolonged exposure is not necessary to induce a stochastic effect, although the potential risk of a stochastic effect increases with additional radiation. 3 This factor can lead to the development of a malignancy, for example, the phenotype of this stochastic effect may take years to become apparent. ...

Cumulative radiation exposure during thoracic endovascular aneurysm repair and subsequent follow-up

European journal of cardio-thoracic surgery: official journal of the European Association for Cardio-thoracic Surgery

... The implications of the 'learning curve' are even more problematic when it is protracted such as in complex interventions [14]. The effect of the 'learning curve' on outcome also extends beyond the surgeon into the institutional experience [15,16]. It is, therefore, paramount for the 'learning curve' of the team including the surgeon, anaesthesiologist, perfusionist and scrub team to be considered as a minimally invasive cardiac surgery programme is traversed [17][18][19]. ...

Transapical Aortic Valve Implantation in High-Risk Patients With Severe Aortic Valve Stenosis
  • Citing Article
  • November 2011

The Annals of Thoracic Surgery

... Colchicine is a second-line therapeutic option for pericarditis (Dainese et al., 2011;Deftereos et al., 2013b). Adding colchicine to standard treatments can reduce the recurrence rate of patients with pericarditis. ...

Recurrent pericardial effusion after cardiac surgery: The use of colchicine after recalcitrant conventional therapy

Journal of Cardiothoracic Surgery

... Only evaluable segments are considered for analysis. Comparison between coronary computed tomography and invasive angiography, using a cut-off value of 50% lumen stenosis, are displayed [27,28,32,[40][41][42][43]45]. ...

Feasibility and accuracy of a comprehensive multidetector computed tomography acquisition for patients referred for balloon-expandable transcatheter aortic valve implantation
  • Citing Article
  • June 2011

American Heart Journal