The Outcomes for Different Biological Heart Valve Prostheses in Surgical Aortic Valve Replacement before and after the Introduction of Transcatheter Aortic Valve Implantation

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

* The authors showed the outcome for different types of biological heart valve prostheses in the surgical treatment of aortic valve disease in 2,500 patients before and after the introduction of transcatheter aortic valve implantation. This study is a monocentric real-life experience.

* The concluded that surgical aortic valve replacement remains a viable option for the future. 

This study is novel and interesting.

Methods and Results are very well written.

I have only two minor suggestions:

1.        The title is too long. It should be more concise.

2.        The introduction should be expanded including more issues. For example cite and comment the following study  (10.3390/prosthesis6010014).

Author Response

* The authors showed the outcome for different types of biological heart valve prostheses in the surgical treatment of aortic valve disease in 2,500 patients before and after the introduction of transcatheter aortic valve implantation. This study is a monocentric real-life experience.

* The concluded that surgical aortic valve replacement remains a viable option for the future. 

This study is novel and interesting.

Methods and Results are very well written.

I have only two minor suggestions:

1. The title is too long. It should be more concise.

            This has been shortened accordingly

2. The introduction should be expanded including more issues. For example cite and comment the following study  (10.3390/prosthesis6010014).

• This is the very recent series published by Jiritano, in which major adverse cardiovascular events, bleeding and the use of blood products in SAVR versus TAVI are discussed. In-hospital mortality was the secondary end-point. The patients were subdivided into octogenarians and younger age group. Their conclusion is that “age alone should not be considered as a predictive factor for post-operative adverse events or in-hospital mortality in elderly patients with severe symptomatic AS”. Our own finding in 2004 was that need for urgent or emergent surgery was of more importance for mortality than age over 80 years (reference 7) and was confirmed in a series comparing patients of 80-84 years with patients aged 85 years or more (reference 8)
• The prostheses in use for SAVR were the Carpentier-Edwards Magna Ease (CEME), which was also used in the majority of our patients. For TAVI, three generations of Sapien balloon expandable valves were used. The TAVI procedure and the details of successive improvements of the valves (use of cobalt-chromium, lowering of the profile, use of an sealing cuff), however, is beyond the scope of this manuscript.
• Of interest are the need for blood products (RBC, plasma products and thrombocytes). This was comparable for both age groups and for both procedures. The occurrence of MACE, including bleeding showed the same pattern.
• However, mortality in the SAVR group was higher in octogenarian patients, compared to the younger. This age effect was not seen in TAVI patients. Absolute numbers were low.

Elements of interest to expand the introduction for the current manuscript are

• The use of the CEME device throughout the referenced series as well as in the current series, after the introduction of TAVI in 2008
• The parallel improvement of de surgical devices (Carpentier-Edwards, Carpentier-Edwards Magna and Carpentier-Edwards Magna Ease) and the TAVI devices ( Sapient, Sapien XT and Sapien 3) with the common aspect of lowering the device profile
• The comparability of the age of the surgical group in the referenced series and current series
• The comparability of outcome irrespective of age and procedure with the exception of age over 80 after SAVR.
• The conclusion that age alone is not the main determinant of outcome

We consider the additional reference valuable.

Reviewer 2 Report

Comments and Suggestions for Authors

Dear authors

It is a great pleasure for me to review your paper

The topic is very interested.

The study is well-designed 

I suggest you to deepen the discussion. Please cite and briefly discuss the following papers:

- Lacquaniti et al . Surgical aortic valve replacement and renal dysfunction: from acute kidney injury to chronic disease. JCM 2024 May 16;13(10)

- Lansac E., Aortic valve surgery in nonelderly patients: insights gained from AVIATOR. Seminars in Thoracic and Cardiovascular Surgery 2019; 31 (4): 643

-Sansone F et al Long term follow-up of stentless prosthesis J. Cardiol.2014 May; 63 (5): 365-372

Moreover, why didn't you divide the patients in two groups to compare the standard  bioprotheses with the rapid deployment ones?

 

 

Author Response

It is a great pleasure for me to review your paper

The topic is very interested.

The study is well-designed 

I suggest you to deepen the discussion. Please cite and briefly discuss the following papers:

- Lacquaniti et al . Surgical aortic valve replacement and renal dysfunction: from acute kidney injury to chronic disease. JCM 2024 May 16;13(10)

This article discusses in admirable detail the risk factors for acute renal injury after SAVR and the development of CKD in the following period. The interesting aspect was the effect of the stage of CKD on the rapidity of the development of acute renal injury. The logistic regression identified the severity of CKD as well as CPB and cross-clamp time as predictors. This is in line with the current observation that ARI is less common with isolated SAVR, compared to SAVR with an associated procedure. For both surgical groups, the rate of postoperative AKI rate increased over time, as preoperative CKD (both groups) and CPB time (for combined surgery) did.  Association of other procedures is expected to lead to longer operation times. It is also interesting to observe that, although high age was identified as a factor with a significant effect, acute renal injury after SAVR is also a problem in a younger patient group (66+/-11 years), part of whom received a mechanical valve prosthesis.

- Lansac E., Aortic valve surgery in nonelderly patients: insights gained from AVIATOR. Seminars in Thoracic and Cardiovascular Surgery 2019; 31 (4): 643

This interesting manuscript deals with several problems addressing the complication rates, reoperation rate and survival after aortic valve procedures in relatively young patients. They have a longer exposure to potential valve-related complications. There are interesting notes concerning tissue heart valve engineering and  the potential bias of industry against aortic valve repair. However, the current patient population is older and suffers mainly from degenerative aortic valve disease with stenosis. Although implantation of a mechanical valve was an exclusion criterion for the current series, it is noteworthy that loss of life expectancy after implantation of an aortic valve bioprosthesis results in a loss of life expectancy, which is worse after a biological valve, compared to a mechanical prosthesis. With biological valve prostheses, there is also a higher reintervention rate. The use of valve-in-valve TAVI might be promising in this respect, but this still remains to be documented. The discussion is expanded with a remark in this respect. Aortic valve repair and the Ross procedure do not play a role in the current elderly population with mostly a degenerated aortic valve. Moreover, some authors see the Ross procedure as a ‘Trojan horse’ (https://doi.org/10.1093/eurheartj/ehl550)

-Sansone F et al Long term follow-up of stentless prosthesis J. Cardiol.2014 May; 63 (5): 365-372

This reference deals with the use of stentless aortic valve prostheses in patients with small annuli. In our patient population, this is was not a routine procedure. Stentless valves show a better hemodynamic performance during exercise but are technically more demanding to implant. These devices seem less suitable for elderly patients with limited exercise capacity.

In the reference, the patient population receiving a stentless device is considerable younger compared to ours (61+/-12y) and there is a much higher proportion of redo-surgery (31%). The rate of infective endocarditis is also higher (27%). Operation times are also considerably younger, which is undesirable in elderly patients. This also goes against the concept of the use of a Perceval device. The comparison between stented and stentless devices in the reference does not offer seemingly long-term (survival, adverse event rate, reoperation) advantages of one over the other. The need for permanent pacemaker implantation in the stentless groups seems a mystery, but this is worthwhile to mention since this is also a problem with rapid deployment valves.

Moreover, why didn't you divide the patients in two groups to compare the standard  bioprotheses with the rapid deployment ones?

This is indeed an important issue. The comparison with respect to mortality would require a propensity score match analysis since the Perceval group is much smaller and has serious age and comorbidity differences than the standard bioprostheses. This would result in low numbers. As alternative, a logistic regression could be offered, in which the effect of the rapid deployment valve on 30-day mortality could be established. This shows that there are five predictors (age over 80 years, chronic renal and pulmonary disease, congestive heart failure and need for urgent SAVR). In comparison, the use of the Perceval is far from being a predictor for this outcome, since the p-value is over 0.9.

Predictors for 30-day mortality are presented in the manuscript; the data concerning the Perceval device can be found within the text.

Hospital mortality		p-value	Odds Ratio	95% CI
				Lower	Upper
	age >80y	,014	1,819	1,126	2,938
	COPD	<,001	2,320	1,430	3,766
	CKD	,002	2,128	1,307	3,464
	CHF	,011	1,972	1,169	3,325
	Urgent SAVR	<,001	2,958	1,767	4,952
	perceval	,961	1,029	,335	3,161

We consider the added references as well as the table an important improvement of the paper.

Round 2

Reviewer 2 Report

Comments and Suggestions for Authors

I think that this paper should be accepted outright