Giulio Rizzoli added an update.
Twenty year patient survival and 17 year complications of isolated Mitral Biocor Standard porcine prosthesis
Rizzoli G, Bottio T, Comisso M, Faggian G, Milano A, et al. (2J Clin Exp Cardiolog 8:508, 2017 . doi: 10.4172/2155-9880.1000508
I publisched two papers after my retirement: My last paper : "Pharyngeal hemorrhage: a catstrophic post-operative event" which can be read and downloades at this adress: file:///C:/Users/User/Downloads/article_ejbps_volume_4_november_issue_11_1509430839.pdf . This paper reports an unfortunate case I attended at the end of my carrier. It was the consequence of a missmatch between increasing case volume vs. restricted resources imposed by healthcare economy, resulting in a decreased safety of the surgical environment, both for the patient and for the attending surgeon.I t describes a typical example of malpractice in which a series of medical omissions were consecutively dismally aligned, resulting in patient’s death and my earlier retirement. It begann with a very long-lasting surgical case requiring the use of extracorporeal circulation, a double anti-aggregated patient, a fast track extubation and an Intensive Care Unit staffed with a second year anesthesia resident: lacking of video-laryngoscope, capnography, cricothyroidotomy set and training. It resulted in the inability to diagnose and neutralize an extremely rare and previously unknown complication.
My penultimate paper "Twenty year patient survival and 17 year complications of isolated Mitral Biocor Standard porcine prosthesisRizzoli G et Al. . (2017) J Clin Exp Cardiolog 8:508 . doi: 10.4172/2155-9880.1000508 " requires a short resumee:
I have been active in the Cardiac Surgery department of the University of Padova from 1970 to 2010 and according to Pubmed I authored or coauthored 96 papers.In most of the coauthored papers my principal contribution was devoted to the collection and analysis of data, because of some competence in statistical analysis of medical data and in the “Research of Outcome”, which I acquired in 1979 as a pupil of Prof. Eugene Blackstone at the University of Alabama.I have also “personally” collected within an Access Database more than 13000 records of patients who underwent valvular operations at the University of Padova that have been used in several of these papers.
It is one which offers an example of my lasting contribution to valvular research and I decided to publish it because I felt it was a worthy conclusion of it. It was left in the drawer at the time of my retirement in 2010. It was judged as potentially acceptable from the editor of JTCVS but finally refuted because of the strong opposition of a reviewer, complaining the lack of echo data which I was no longer able to collect. This was a fault because prosthetic valve must undergo the test of time concerning their durability and the Biocor Valve is a device at risk of tissue calcification, detected from echocardiography.
This is nonetheless just one of the purposes of prospective studies:the main purpose is to verify our ability to cure, that depends from overall operative strategy. For this reason we joined our data with those of the University of Verona, were the use of the Standard Biocor Valve was initially started on 1989 from prof. Dino Casarotto, so to cover the whole range of 20 years. Ideally we should be able to identify the mode and causes of death, but this is seldom possible. A valid alternative, unrelated to disease-linked prejudice, is to measure the ability to restore in our patients a life expectation similar to the one of the general population matched for age, sex and race. Success may be graphically certified by inclusion of general population survival curves within the 95% or 70% confidence limits of our patients survival. The amount of our failure may be appreciated in fig. 2 and appears that we pay the toll of a rather high peri-operative hazard phase, the following survival slope is rather similar to the general population slope.
Comparison of survival results in the international arena requires a “neutral benchmark”. An easily available common standard is the one offered from US survival data.The Finnish series, published by Mykén  in 2009, reported a survival which was significantly better than ours (6% vs. 16%), but the mean age of their patients was 65 year vs.73 years of ours, an 8 year difference obviously related to a shorter survival and to a lower rate of calcific degeneration.
The hazard parametric analysis, which in this paper utilized the Royston-Parmar model  instead of the more popular Blackstone hazard model , identified three more risk factors beside operative age that were independently and significantly related to shorter survival: NYHA class, male sex, pulmonary hypertension. Figure 4 of the paper clearly shows how survival of patients in the most favourable risk factors scenario (female, Nyha 1-3, age≤71,MPAP≤35) compares to survival of the general population but this is not so in the worst scenario, justifying the conclusions of the paper and the search of alternative surgical strategies offered by up to date technology, which in Padova is actively pursued by Gino Gerosa, chief of the cardiac surgery department .
I want to also emphasize an issue which is of public interest, therefore I reprint a paragraph of the paper discussion: "A large series has been recently published from Mykén in Finland. Finland and Italy are both founded on a public health service and committed to high quality data, nonetheless we must complain that Italian citizens and statistical data repositories oppose resistance to share individual data with researchers because of “privacy” issues and legislation ”
In this Italian reference the economist prof. Ichino writes: ”It's a matter of democracy and transparency: the scientific community must have access to microdata to check and replicate the results. Some might think that only economists have these needs. It's not like that. The heart surgeon Giulio Rizzoli says: Among the obstacles that our country imposes on scientific progress we include the recent adoption of privacy regulations that prevent our national statistical institute to allow us to view the death reports of our patients, recorded by our colleagues.
The investigation of the mode or cause of death is essential to understand the risks associated with the use of new biomedical technologies, including prostheses. In our case it must answer the question if death was due to cardiac causes, to complications of prosthesis or to cardiac unrelated disease/events-.This is a particularly significant example of the fact that privacy cannot be considered an absolute good. The data that Rizzoli cannot obtain would provide essential information to improve cardiosurgical therapies with positive effects for the whole nation".
In the Age of Genomics the new paradigm of medicine is offering personalized treatments for each patient, likewise medical statistics must individualize the evaluation of the results based on the constellation of risk factors of the individual patient.
In Italy we often rely on the Outcome Research coming from the USA, that has predominantly private health care. I believe that if health is provided from the state, thanks to taxes payed from all the citizens, as in our health system and in most Europe, there is a moral obligation of the ill to allow the experience gained during his own treatment to be used to increase the healing chances of other citizen. At the contrary, the law of privacy, which is frequently circumvented from gossip, very efficiently limits the skill of Italian surgeons to monitor the outcomes of their operations.T his should be a worldwide privilege of the medical professionals because also for a world recognized scientist as Eugene Blackstone, it is difficult to tackle informations concerning patients, despite consent. He complains that, although the Institute of Medicine envisioned a “Learning Health System” that would transform medicine by 2020 from shared health information, that has not yet happened, as individual institutions are sinkholes of medical information in the US as well.
1] Mykén PS, Bech-Hansen O. (2009) A 20 year experience of 1712 patients with the Biocor porcine bioprosthesis JTCVS 137:76-81
2] Royston P, Parmar MK (2002) Flexible proportional hazard and proportional odds model for censored survival data, with applications to prognostic modeling and estimation of treatment effects Statistics in medicine 21:2175-97
3] Blackstone EH, Naftel DC, Turner ME Jr. (1986) The decomposition of time-varying hazard into phases, each incorporating a separate stream of concomitant information. JASA 81:615-24.
4] Ichino A. (2005) L’ISTAT che vorremmo. (the national statistic institute we would like to have) La Voce
5] Colli A, Manzan E, Aidietis A, ..... Gerosa G.(2018) An early European experience with transapical off-pump mitral valve repair with NeoChord implantation. Eur J Cardiothorac Surg. Mar 5. doi: 10.1093/ejcts/ezy064. [Epub ahead of print]Eur J Cardiothorac Surg. 2018 Mar 5. doi: 10.1093/ejcts/ezy064. [Epub ahead of print]